Q2 2024 Amgen Inc Earnings Call

August 6, 2024

Operator: --We will also make some forward-looking statements, which are qualified by our safe harbor statement. And please note that actual results can vary materially. Over to you, Bob.

Robert A. Bradway: Okay. Well, thank you, Justin, and let me thank all of you for joining the call today. We're especially grateful in light of all of the volatility in the markets that you would carve out the time to be with us. So thank you. Through the first half of the year, our business is performing well, and we remain confident in our ability to deliver attractive long-term growth. We're achieving strong results the same way we always have, which is by providing innovative medicines to address challenging diseases. Starting with the in-market portfolio. Second quarter revenues grew 20% to $8.4 billion with numerous medicines delivering double-digit sales growth, including in general medicine, REPATHA and EVENITY, in oncology, of course, BLINCYTO, an inflammation TEZSPIRE, and then turning to rare disease, which delivered more than $1 billion on the quarter. I would highlight that KRYSTEXXA, UPLIZNA and TAVNEOS, each delivered at least double-digit sales growth in the quarter, and TEPEZZA grew 8% year-over-year and 13% quarter-over-quarter. All of these first or best-in-class medicines are still early in their life cycles and have plenty of room to run through geographic expansion, new indications and/or new formulations. You'll hear more about these brands in a moment.

Bob Bradway: Through the first half of the year, our business is performing well, and we remain confident in our ability to deliver attractive long-term growth. We're achieving strong results the same way we always have, which is by providing innovative medicines to address challenging diseases. Starting with the in-market portfolio, second quarter revenues grew 20% to $8.4 billion, with numerous medicines delivering double-digit sales growth, including, in general medicine, Repatha and Avenity; in oncology, of course, Blincito, and inflammation, Tespire; and then turning to rare disease, which delivered more than a billion dollars in the quarter.

Bob Bradway: I would highlight that Cristexa, Uplizna, and Tavneos each delivered at least double-digit sales growth in the quarter, and Tepeza grew 8% year over year and 13% quarter over quarter. All of these first or best-in-class medicines are still early in their life cycles and have plenty of room to grow through geographic expansion, new indications, and or new formulations. You'll hear more about these brands in a moment.

Robert A. Bradway: Starting with the in-market portfolio. Second quarter revenues grew 20% to $8.4 billion with numerous medicines delivering double-digit sales growth, including in general medicine, REPATHA and EVENITY, in oncology, of course, BLINCYTO, an inflammation TEZSPIRE, and then turning to rare disease, which delivered more than $1 billion on the quarter. I would highlight that KRYSTEXXA, UPLIZNA and TAVNEOS, each delivered at least double-digit sales growth in the quarter, and TEPEZZA grew 8% year-over-year and 13% quarter-over-quarter. All of these first or best-in-class medicines are still early in their life cycles and have plenty of room to run through geographic expansion, new indications and/or new formulations. You'll hear more about these brands in a moment.

Robert A. Bradway: Turning to research and development. We believe our pipeline looks very promising as well, not just in obesity, but across all of our therapeutic areas. We told you at the beginning of the year that we were anticipating more than a dozen significant pipeline milestones in 2024. We are, so far, so good. In the second quarter alone, we received accelerated approval for IMDELLTRA, a landmark new medicine for small cell lung cancer. And in fact, the physicians I've spoken to since approval are really excited about this drug as the first meaningful innovation in decades for these patients. We also received approval for BLINCYTO in the frontline treatment for B-cell precursor acute lymphoblastic leukemia, based on significantly improved overall survival rates. The frontline approval meaningfully expands the potential impact of BLINCYTO for all patients with B-ALL. We announced impressive Phase III data for UPLIZNA in IGG4-related disease, which is a grievous illness for which there are no currently approved therapies of any kind. Building on our success with TEZSPIRE in treating severe asthma, we announced exciting data from our Phase II study in patients with chronic obstructive pulmonary disease that earned this molecule breakthrough therapy designation. COPD is the world's third leading cause of death, and new treatment options are very much needed.

Bob Bradway: In the second quarter alone, we received accelerated approval for MDeltra, a landmark new medicine for small cell lung cancer. In fact, the physicians I've spoken to since approval are really excited about this drug as the first meaningful innovation in decades for these patients. We also received approval for Blincito as the frontline treatment for B-cell precursor acute lymphoblastic leukemia based on significantly improved overall survival rates. The front line approval meaningfully expands the potential impact of Blincito for all patients with BALL. We announced impressive Phase III data for Euplizma, an IgG4-related disease for which there are currently no currently approved therapies of any kind. Building on our success with Tess Spire in treating severe asthma, we announced exciting data from our Phase 2 study in patients with chronic obstructive pulmonary disease that earned this molecule breakthrough therapy designation. COPD is the world's third leading cause of death, and new treatment options are very much needed.

Robert A. Bradway: We also received approval for BLINCYTO in the frontline treatment for B-cell precursor acute lymphoblastic leukemia, based on significantly improved overall survival rates. The frontline approval meaningfully expands the potential impact of BLINCYTO for all patients with B-ALL. We announced impressive Phase III data for UPLIZNA in IGG4-related disease, which is a grievous illness for which there are no currently approved therapies of any kind. Building on our success with TEZSPIRE in treating severe asthma, we announced exciting data from our Phase II study in patients with chronic obstructive pulmonary disease that earned this molecule breakthrough therapy designation. COPD is the world's third leading cause of death, and new treatment options are very much needed.

Bob Bradway: We announced impressive Phase III data for Euplizma, an IgG4-related disease for which there are currently no currently approved therapies of any kind. Building on our success with Tess Spire in treating severe asthma, we announced exciting data from our Phase 2 study in patients with chronic obstructive pulmonary disease that earned this molecule breakthrough therapy designation. COPD is the world's third leading cause of death, and new treatment options are very much needed.

Robert A. Bradway: We look forward to additional data readouts later this year across therapeutic areas, highlighted, of course, by top line data from the ongoing MariTide Phase II study. We're encouraged by the emerging data in this field, particularly in cardiovascular and renal disease, areas of long-standing strategic focus for us. We are laser focused on preparing to launch a broad Phase III program for MariTide that includes obesity, obesity-related conditions and type 2 diabetes, and we're further ramping our investment to support MariTide in the rest of the pipeline. You'll hear more about that pipeline shortly on this call. All in all, this is a very exciting time for us at Amgen. And as always, I'm grateful to my Amgen colleagues all around the world for their enduring commitment to patients. And now let me turn things over to Murdo.

Bob Bradway: You'll hear more about that pipeline shortly on this call. All in all, this is a very exciting time for us at Amgen, and, as always, I'm grateful to my Amgen colleagues all around the world for their enduring commitment to patience. Now, let me turn things over to Murdo.

Murdo Gordon: Thanks, Bob. Execution was strong in the second quarter, driving 20% year-over-year sales growth and all of our regions delivered attractive growth. Sales of 12 products grew at least double digits, including REPATHA, TEZSPIRE, EVENITY, TAVNEOS and BLINCYTO, all brands that are important to our future growth. Starting with our General Medicine portfolio. Sales of REPATHA, EVENITY and Prolia collectively grew 20% year-over-year in the second quarter, driven by volume growth. REPATHA sales increased 25% year-over-year to $532 million for the second quarter, now well on its way to becoming a multibillion-dollar business. In the quarter, we saw year-over-year volume growth of 46%, partially offset by lower net selling price. In the U.S., we see increased recognition of the importance of lowering LDL cholesterol by health care providers, payers and patients, which has significantly accelerated volume growth for REPATHA. Our efforts have broadened insurance coverage and removed prior authorization requirements by several payers. In a recent survey, roughly 95% of cardiologists responded that REPATHA is accessible, and that access has improved significantly versus two years ago.

Murdo Gordon: In the quarter, we saw year-over-year volume growth of 46%, partially offset by lower net selling price. In the U.S., we see increased recognition of the importance of lowering LDL cholesterol by health care providers, payers, and patients, which has significantly accelerated volume growth for hepatitis. Our efforts have broadened insurance coverage and removed prior authorization requirements by several payers. In a recent survey, roughly 95% of cardiologists responded that Repatha is accessible and that access has improved significantly versus two years ago.

Murdo Gordon: In the U.S., we see increased recognition of the importance of lowering LDL cholesterol by health care providers, payers and patients, which has significantly accelerated volume growth for REPATHA. Our efforts have broadened insurance coverage and removed prior authorization requirements by several payers. In a recent survey, roughly 95% of cardiologists responded that REPATHA is accessible, and that access has improved significantly versus two years ago.

Murdo Gordon: In a recent survey, roughly 95% of cardiologists responded that Repatha is accessible and that access has improved significantly versus two years ago. Eventide sales increased 39% year-over-year to $391 million for the second quarter. In the U.S., volume growth was supported by both increased prescription volume from existing Avenity prescribers and an expansion of new prescribers. In Japan, Avenity has been prescribed to approximately 600,000 patients to date and continues to be the segment leader with 45% of the bone builder segment. There are many women who remain at risk of a fracture due to postmenopausal osteoporosis.

In a recent survey, roughly 95% of cardiologists responded that Repatha is accessible and that access has improved significantly versus two years ago.

Murdo Gordon: Eventide sales increased 39% year-over-year to $391 million for the second quarter. In the U.S., volume growth was supported by both increased prescription volume from existing Avenity prescribers and an expansion of new prescribers. In Japan, Avenity has been prescribed to approximately 600,000 patients to date and continues to be the segment leader with 45% of the bone builder segment. There are many women who remain at risk of a fracture due to postmenopausal osteoporosis. We're encouraged by the growth momentum we are driving and have conviction in the potential for identity to help even more patients. Prolia sales increased 13% year-over-year to $1.2 billion for the second quarter. Volume growth continues to be supported by real-world evidence demonstrating Prolia's superiority in reducing fracture risk when compared to alendronate in treatment-naive patients with postmenopausal osteoporosis at high risk of fracture. In inflammation, test fire continues its strong trajectory with $234 million in sales in the second quarter. Sales increased 76% year-over-year, primarily driven by uptake of the pre-filled single-use pen. We see strong growth opportunities for Tespire given its unique differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma.

Murdo Gordon: We're encouraged by the growth momentum we are driving and have conviction in the potential for identity to help even more patients. Prolia sales increased 13% year-over-year to $1.2 billion for the second quarter. Volume growth continues to be supported by real-world evidence demonstrating Prolia's superiority in reducing fracture risk when compared to alendronate in treatment-naive patients with postmenopausal osteoporosis at high risk of fracture. In inflammation, test fire continues its strong trajectory with $234 million in sales in the second quarter. Sales increased 76% year-over-year, primarily driven by uptake of the pre-filled single-use pen. We see strong growth opportunities for Tespire given its unique differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma.

Murdo Gordon: Prolia sales increased 13% year-over-year to $1.2 billion for the second quarter. Volume growth continues to be supported by real-world evidence demonstrating Prolia's superiority in reducing fracture risk when compared to alendronate in treatment-naive patients with postmenopausal osteoporosis at high risk of fracture. In inflammation, TEZSPIRE continues its strong trajectory with $234 million in sales in the second quarter. Sales increased 76% year-over-year, primarily driven by uptake of the pre-filled single-use pen. We see strong growth opportunities for TEZSPIRE given its unique differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma.

Murdo Gordon: In inflammation, test fire continues its strong trajectory with $234 million in sales in the second quarter. Sales increased 76% year-over-year, primarily driven by uptake of the pre-filled single-use pen. We see strong growth opportunities for Tespire given its unique differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma. Schmitt, Sven Birnbaum, In the U.S., we saw 3% year-over-year growth in new patient prescriptions in the quarter, driven by strong execution by our dermatology sales force and increased Otesla direct-to-consumer media activity.

In inflammation, test fire continues its strong trajectory with $234 million in sales in the second quarter. Sales increased 76% year-over-year, primarily driven by uptake of the pre-filled single-use pen. We see strong growth opportunities for Tespire given its unique differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma.

Murdo Gordon: OTEZLA sales decreased 9% year-over-year for the second quarter with 2% volume growth offset by lower net selling price and unfavorable changes to estimated sales deductions. In the U.S., we saw a 3% year-over-year growth in new patient prescriptions in the quarter, driven by strong execution by our dermatology sales force and increased OTEZLA direct-to-consumer media activity. We've seen an increasingly competitive environment in dermatology with the introduction of novel topicals and new biologic treatments. OTEZLA retains an important role in this landscape given its broad label, safety profile and unique positioning as a first systemic treatment option for patients with cirrhosis. ENBREL sales decreased 15% year-over-year for the second quarter, primarily driven by lower net selling price. Going forward, we expect continued declining net selling price and relatively flat volumes. ENBREL is known for its efficacy and trusted by physicians. Its substantial health benefits and cash flow generation provide a solid foundation for our business.

Murdo Gordon: We've seen an increasingly competitive environment in dermatology, with the introduction of novel topicals and new biologic treatments. Otesla retains an important role in this landscape, given its broad label, safety profile, and unique positioning as a first systemic treatment option for patients with psoriasis. MBREL sales decreased 15% year-over-year for the second quarter, primarily driven by a lower net selling price. Going forward, we expect continued declining net selling price and relatively flat volume. Ambrose is known for its efficacy and trusted by physicians. Its substantial health benefits and cash flow generation provide a solid foundation for our business.

Murdo Gordon: Going forward, we expect continued declining net selling price and relatively flat volumes. ENBREL is known for its efficacy and trusted by physicians. Its substantial health benefits and cash flow generation provide a solid foundation for our business.

Murdo Gordon: Ambrose is known for its efficacy and trusted by physicians. Its substantial health benefits and cash flow generation provide a solid foundation for our business. Turning now to biosimilars, where sales of our biosimilar products were relatively stable year over year for the second quarter, we're positioned for future growth with upcoming launches. Lana biosimilar to Stellara and Bikambia biosimilar to Solaris are both expected to launch in the US in Q1 of 2025.

Ambrose is known for its efficacy and trusted by physicians. Its substantial health benefits and cash flow generation provide a solid foundation for our business.

Murdo Gordon: Turning now to biosimilars, where sales of our biosimilar products were relatively stable year-over-year for the second quarter. We're positioned for future growth with upcoming launches, WEZLANA, a biosimilar to STELARA and BEKEMV, a biosimilar to SOLIRIS, are both expected to launch in the U.S. in Q1 of 2025. Our vertically integrated biosimilar business model ensures efficiency and provides attractive cash flows and returns for our shareholders. In oncology, sales of our seven innovative products, BLINCYTO, LUMAKRAS, VECTIBIX, KYPROLIS, NPLATE, XGEVA and IMDELLTRA grew 12% year-over-year for the second quarter, driven by volume growth and higher net selling prices. In total, these products contributed almost $2 billion of sales in the second quarter. BLINCYTO sales grew 28% year-over-year to $264 million for the second quarter, driven by broad prescribing across academic and community segments for patients with B-cell ALL. BLINCYTO was recently granted approval by the U.S. Food and Drug Administration as a frontline consolidation treatment for patients with Philadelphia chromosome-negative B-cell ALL. Our commercial and medical teams are engaging key academic, regional and community customers in establishing BLINCYTO as a standard of care in this setting.

Murdo Gordon: Chair, Stars and Blades, Brian Morgan, In oncology, sales of our seven innovative products, Lincyto, Lumicraz, Vectabix, Kyprolis, Endplate, Xgeva, and Imdeltra, grew 12% year-over-year for the second quarter, driven by volume growth and higher net selling price. In total, these products contributed almost $2 billion in sales in the second quarter. In cycle sales grew 28% year-over-year to $264 million for the second quarter, driven by broad prescribing across academic and community segments for patients with B-cell ALL. Blincito was recently granted approval by the U.S. Food and Drug Administration as a frontline consolidation treatment for patients with Philadelphia chromosome negative B-cell ALL. Our commercial and medical teams are engaging key academic, regional, and community customers in establishing Blincito as a standard of care in this setting.

Murdo Gordon: In oncology, sales of our seven innovative products, BLINCYTO, LUMAKRAS, VECTIBIX, KYPROLIS, NPLATE, XGEVA and IMDELLTRA grew 12% year-over-year for the second quarter, driven by volume growth and higher net selling prices. In total, these products contributed almost $2 billion of sales in the second quarter. BLINCYTO sales grew 28% year-over-year to $264 million for the second quarter, driven by broad prescribing across academic and community segments for patients with B-cell ALL. BLINCYTO was recently granted approval by the U.S. Food and Drug Administration as a frontline consolidation treatment for patients with Philadelphia chromosome-negative B-cell ALL. Our commercial and medical teams are engaging key academic, regional and community customers in establishing BLINCYTO as a standard of care in this setting.

Murdo Gordon: Blincito was recently granted approval by the U.S. Food and Drug Administration as a frontline consolidation treatment for patients with Philadelphia chromosome negative B-cell ALL. Our commercial and medical teams are engaging key academic, regional, and community customers in establishing Blincito as a standard of care in this setting. William McGrath sales increased 10% year-over-year to $85 million for the second quarter. We see future growth opportunities for William McGrath coming from launches in new markets and additional indications. Executive sales increased 9% year-over-year to $270 million for the second quarter, now annualizing at over $1 billion.

Blincito was recently granted approval by the U.S. Food and Drug Administration as a frontline consolidation treatment for patients with Philadelphia chromosome negative B-cell ALL. Our commercial and medical teams are engaging key academic, regional, and community customers in establishing Blincito as a standard of care in this setting.

Murdo Gordon: LUMAKRAS sales increased 10% year-over-year to $85 million for the second quarter. We see future growth opportunities for LUMAKRAS coming from launches in new markets and additional indications. Back to back sales increased 9% year-over-year to $270 million for the second quarter, now annualizing at over $1 billion. We also drove strong performance of KYPROLIS, which grew 9% year-over-year and NPLATE, which grew 12% year-over-year. Since our U.S. launch of IMDELLTRA in mid-May, we generated $12 million of sales in the second quarter. IMDELLTRA was recently approved for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. We're seeing strong clinical conviction in IMDELLTRA in both academic and community settings, and while very early in the launch, we're encouraged by the adoption of IMDELLTRA and look forward to its potential to bring new possibilities to patients living with this aggressive disease. I'm pleased with our execution in the quarter, driving accelerated performance for our most important growth brands. And with that, I'll turn it over to Vikram, who will cover our rare disease portfolio.

Vikram Karnani: We also drove strong performance of Kyprolis, which grew 9% year-over-year, and Endplate, which grew 12% year-over-year. Additionally, since our U.S. launch of Imdelta in mid-May, we generated $12 million in sales in the second quarter. Imdelta was recently approved for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. We're seeing strong clinical conviction for MDELTA in both academic and community settings. While this is a very early stage in the launch, we're encouraged by the adoption of MDELTA and look forward to its potential to bring new possibilities to patients living with this aggressive disease. I'm pleased with our execution in the quarter, driving accelerated performance for our most important growth brands. And with that, I'll turn it over to Vikram, who'll cover our rare disease portfolio.

Murdo Gordon: IMDELLTRA was recently approved for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. We're seeing strong clinical conviction in IMDELLTRA in both academic and community settings, and while very early in the launch, we're encouraged by the adoption of IMDELLTRA and look forward to its potential to bring new possibilities to patients living with this aggressive disease. I'm pleased with our execution in the quarter, driving accelerated performance for our most important growth brands. And with that, I'll turn it over to Vikram, who will cover our rare disease portfolio.

Vikram Karnani: Thank you, Murdo. I am pleased to provide an update on rare disease, which delivered product sales of over $1.1 billion in Q2. Beginning with TEPEZZA for the treatment of thyroid-eye disease, second quarter sales were $479 million, reflecting growth of 8% year-over-year and 13% quarter-over-quarter, when compared to results from the legacy Horizon business. Recall that there are roughly 100,000 TED patients in the U.S., and penetration is currently only in the single digits. The main growth opportunity is within the roughly 80% of TED patients who have a low clinical activity score or CAS. We are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists who manage many of the low cash patients who can benefit from TEPEZZA. The impact of thyroid-eye disease on quality of life is often underestimated. So our focus is on educating health care providers about the significant effects on patients, even those with less visible symptoms.

Vikram Karnani: The main growth opportunity is within the roughly 80% of TED patients who have a low clinical activity score or CAS. We are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists who manage many of the low cash patients who can benefit from TEPEZZA. The impact of thyroid-eye disease on quality of life is often underestimated. So our focus is on educating health care providers about the significant effects on patients, even those with less visible symptoms.

Vikram Karnani: The main growth opportunity is within the roughly 80% of TED patients who have a low clinical activity score, or CAS. We are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists who manage many of the low-cast patients who can benefit from TIFEP. The impact of sighted eye disease on quality of life is often underestimated. So our focus is on educating healthcare providers about the significant effects on patients, even those with less visible symptoms.

Vikram Karnani: So our focus is on educating healthcare providers about the significant effects on patients, even those with less visible symptoms. In addition, we are increasing our strategic focus in endocrinology with a dedicated sales force to engage in this important space. We are also making significant strides in improving access, thanks to the recognition of TPEZA's efficacy by payers. To date, we have achieved favorable medical policy changes for greater than 65% of U.S. covered lives, compared to 50% last quarter and just 5% roughly one year ago.

So our focus is on educating healthcare providers about the significant effects on patients, even those with less visible symptoms.

Vikram Karnani: In addition, we are increasing our strategic focus in endocrinology with a dedicated sales force to engage in this important space. We are also making significant strides in improving access. Thanks to the recognition of TEPEZZA's efficacy by payers. To date, we have achieved favorable medical policy changes for greater than 55% of U.S. covered lives, compared to 50% last quarter and just 5% roughly one year ago. We expect to continue this momentum throughout 2024. International expansion remains a meaningful long-term growth opportunity for TEPEZZA with regulatory filings complete or underway in multiple geographies. With Japan as the next significant launch expected by early 2025. We also initiated a Phase III subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation. KRYSTEXXA for patients with chronic refractory gout, delivered $294 million in sales in Q2, representing 20% year-over-year growth driven by volume growth from strong commercial execution. KRYSTEXXA with immunomodulation continues to redefine the standard of care for uncontrolled gout.

Vikram Karnani: We expect to continue this momentum throughout 2024. International expansion remains a meaningful long-term growth opportunity for Tepeza, with regulatory filings complete or underway in multiple geographies, with Japan as the next significant launch expected by early 2025. We also initiated a Phase III subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation. Quistexa for patients with chronic refractory gout delivered $294 million in sales in Q2, representing 20% year-over-year growth, driven by volume growth from strong commercial execution. Quistessa with Immunomodulation continues to redefine the standard of care for uncontrolled gout.

Vikram Karnani: We also initiated a Phase III subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation. Quistexa for patients with chronic refractory gout delivered $294 million in sales in Q2, representing 20% year-over-year growth, driven by volume growth from strong commercial execution. Quistessa with Immunomodulation continues to redefine the standard of care for uncontrolled gout.

Vikram Karnani: We also initiated a Phase III subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation. KRYSTEXXA for patients with chronic refractory gout, delivered $294 million in sales in Q2, representing 20% year-over-year growth driven by volume growth from strong commercial execution. KRYSTEXXA with immunomodulation continues to redefine the standard of care for uncontrolled gout.

Vikram Karnani: UPLIZNA, for patients with neuromyelitis optica spectrum disorder, or NMOSD, delivered $92 million in sales in Q2, representing 35% year-over-year growth. International expansion of UPLIZNA is also underway with launches in multiple ex U.S. markets, including Canada, which launched earlier this year. In addition to NMOSD, we are excited about the impressive Phase III results with UPLIZNA in IGG4-related disease. And the potential it has to address a debilitating condition that impacts more than 20,000 patients in the U.S. We also look forward to the Phase III readout for UPLIZNA in myasthenia gravis later this year. Jay will address these in more detail in a moment. Sales of TAVNEOS were $71 million for the second quarter. Sales increased 137% year-over-year driven by volume growth. In the U.S., more than 3,500 patients with ANCA-associated vasculitis have been treated with TAVNEOS. Over 2,300 health care professionals have now prescribed TAVNEOS, a roughly 35% increase in the prescriber br so far this year. The integration of the legacy Horizon business is progressing nicely as we leverage Amgen's leadership in inflammation, world-class manufacturing and process development and extensive global footprint. Now I will pass it over to Jay for our R&D update.

Vikram Karnani: In addition to NMOSD, we are excited about the impressive Phase III results with UPLIZNA in IGG4-related disease. And the potential it has to address a debilitating condition that impacts more than 20,000 patients in the U.S. We also look forward to the Phase III readout for UPLIZNA in myasthenia gravis later this year. Jay will address these in more detail in a moment.

Vikram Karnani: Sales of TAVNEOS were $71 million for the second quarter. Sales increased 137% year-over-year driven by volume growth. In the U.S., more than 3,500 patients with ANCA-associated vasculitis have been treated with TAVNEOS. Over 2,300 health care professionals have now prescribed TAVNEOS, a roughly 35% increase in the prescriber br so far this year. The integration of the legacy Horizon business is progressing nicely as we leverage Amgen's leadership in inflammation, world-class manufacturing and process development and extensive global footprint. Now I will pass it over to Jay for our R&D update.

Vikram Karnani: In the U.S., more than 3,500 patients with anchor-associated vasculitis have been treated with Tavneos. Additionally, over 2,300 healthcare professionals have now prescribed Tavneos, a roughly 35% increase in the prescriber base so far this year. The integration of the Legacy Horizon business is progressing nicely as we leverage Amgen's leadership in inflammation, world-class manufacturing and process development, and extensive global footprint. Now, I will pass it over to Jay for our R&D update.

Jay Bradner: Thank you, Vikram, and good afternoon, everyone. In the second quarter, we rapidly advanced our broad clinical pipeline of potentially first-in-class or best-in-class programs. We received two approvals in the quarter, a breakthrough therapy designation and delivered exciting clinical data for many programs, while eagerly awaiting additional data readouts later this year. Let's begin with general medicine. As previously mentioned, based on the interim analysis, we are seeing a differentiated profile with MariTide and are confident it will address important unmet medical needs in obesity, obesity-related conditions and type 2 diabetes. We remain on track and look forward to top line 52-week data from the ongoing MariTide Phase II study in late 2024. We are actively planning and expect to initiate a broad Phase III program in obesity, obesity-related conditions and diabetes, along with a Phase II trial investigating MariTide for the treatment of diabetes in patients with and without obesity. Beyond MariTide, we continue to progress our early obesity programs that consists of both oral and injectable incretin and non-incretin approaches.

Jay Bradner: Let's begin with general medicine. As previously mentioned, based on the interim analysis, we are seeing a differentiated profile with MariTide and are confident it will address important unmet medical needs in obesity, obesity-related conditions and type 2 diabetes. We remain on track and look forward to top line 52-week data from the ongoing MariTide Phase II study in late 2024. We are actively planning and expect to initiate a broad Phase III program in obesity, obesity-related conditions and diabetes, along with a Phase II trial investigating MariTide for the treatment of diabetes in patients with and without obesity. Beyond MariTide, we continue to progress our early obesity programs that consists of both oral and injectable incretin and non-incretin approaches.

James Bradner: We remain on track and look forward to top-line 52-week data from the ongoing Meritide Phase 2 study in late 2024. We are actively planning and expect to initiate a broad Phase 3 program in obesity, obesity-related conditions, and diabetes, along with a Phase 2 trial investigating Meritide for the treatment of diabetes in patients with and without obesity. Beyond Maritide, we continue to progress our early obesity programs that consist of both oral and injectable, incretin and non-incretin approaches.

Jay Bradner: We expect one of these programs to enter clinical development later this year. Also in Gen med is olpasiran, our potentially best-in-class Lp(a) targeting small interfering RNA medicine, the fully enrolled Phase III cardiovascular outcomes trial of olpasiran continues to progress. To remind, Lp(a) is a genetically defined cardiovascular risk factor that is elevated in approximately 20% of individuals and for whom no effective or targeted therapies currently exist. In oncology, we continue to deliver on high conviction targets with differentiated therapies capable of delivering transformative clinical benefit for patients. Let's begin with IMDELLTRA, a first-in-class bispecific T-cell engager or BiTE molecule targeting DLL3 for small cell lung cancer. We're very pleased that the FDA granted accelerated approval to IMDELLTRA for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-brd chemotherapy. Further, we are pleased that the NCCN guidelines have been updated to include IMDELLTRA as a preferred option for patients with a chemotherapy-free interval less than or equal to six months and as an other recommended treatment option for patients with a chemotherapy-free interval greater than six months. Based on the remarkable activity observed as a single agent in patients receiving second and third-line therapy, we are rapidly advancing IMDELLTRA into frontline therapy with three Phase III studies underway in both extensive and limited stage disease.

Jay Bradner: In oncology, we continue to deliver on high conviction targets with differentiated therapies capable of delivering transformative clinical benefit for patients. Let's begin with IMDELLTRA, a first-in-class bispecific T-cell engager or BiTE molecule targeting DLL3 for small cell lung cancer. We're very pleased that the FDA granted accelerated approval to IMDELLTRA for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-brd chemotherapy. Further, we are pleased that the NCCN guidelines have been updated to include IMDELLTRA as a preferred option for patients with a chemotherapy-free interval less than or equal to six months and as an other recommended treatment option for patients with a chemotherapy-free interval greater than six months.

James Bradner: In oncology, we continue to deliver on high-conviction targets with differentiated therapies capable of delivering transformative clinical benefits for patients. Let's begin with Imdeltra, a first-in-class bispecific T-cell engager, or BITE molecule, targeting DLL3 for small-cell lung cancer. We're very pleased that the FDA granted accelerated approval to Imdeltra for the treatment of adult patients with extensive-stage small-cell lung cancer who have disease progression on or after platinum-based chemotherapy. Furthermore, we are pleased that the NCCN guidelines have been updated to include Imdeltra as a preferred option for patients with a chemotherapy-free interval less than or equal to six months and as an alternative treatment option for patients with a chemotherapy-free interval greater than six months. Based on the remarkable activity observed as a single agent in patients receiving second and third-line therapy, we are rapidly advancing Imdeltra into front-line therapy, with three Phase III studies underway in both extensive and limited-stage disease.

Jay Bradner: Based on the remarkable activity observed as a single agent in patients receiving second and third-line therapy, we are rapidly advancing IMDELLTRA into frontline therapy with three Phase III studies underway in both extensive and limited stage disease. One of these studies, DeLLphi-304, our confirmatory Phase III study in second-line small cell lung cancer has completed enrollment. Notably, IMDELLTRA is the first bispecific T-cell engager approved to treat a common solid tumor. The present study of tarlatamab in earlier lines and in the context of lower tumor burden, draws from our experience with our first approved bispecific T-cell engager BLINCYTO and B-cell acute lymphoblastic leukemia. Here, we observed a dramatic improvement in overall survival in minimal residual disease negative patients, along with improved tolerability. These BLINCYTO data provide evidence that directing the T cell in this manner is an effective means of finding and eliminating residual cancer cells that are drivers of occurrence. This June, brd on the profound survival benefit observed in the treatment of frontline disease, the FDA approved an additional indication for BLINCYTO for the treatment of adult and pediatric patients one month or older with CD19 positive, Philadelphia chromosome negative, B-cell ALL and the consolidation phase of treatment, here regardless of minimal residual disease status. We continue to seek to expand the impact of BLINCYTO in newly diagnosed B-ALL through ongoing studies and with the further investigation of subcutaneous administration.

James Bradner: Based on the remarkable activity observed as a single agent in patients receiving second and third-line therapy, we are rapidly advancing Imdeltra into front-line therapy, with three Phase III studies underway in both extensive and limited-stage disease. One of these studies, Delphi 304, our confirmatory Phase III study in second-line small cell lung cancer, has completed enrollment. Notably, mDelta is the first bispecific T cell engager approved to treat a common solid tumor. The present study of tarlatumab in earlier lines, and in the context of lower tumor burden, draws from our experience with our first approved bispecific T cell engager, Blencito, in B cell acute lymphoblastic leukemia.

Based on the remarkable activity observed as a single agent in patients receiving second and third-line therapy, we are rapidly advancing Imdeltra into front-line therapy, with three Phase III studies underway in both extensive and limited-stage disease.

One of these studies, Delphi 304, our confirmatory Phase III study in second-line small cell lung cancer, has completed enrollment. Notably, mDelta is the first bispecific T cell engager approved to treat a common solid tumor. The present study of tarlatumab in earlier lines, and in the context of lower tumor burden, draws from our experience with our first approved bispecific T cell engager, Blencito, in B cell acute lymphoblastic leukemia. Here, we observed a dramatic improvement in overall survival in minimal residual disease negative patients along with improved tolerability. These Blinn-Saito data provide evidence that directing the T-cell in this manner is an effective means of finding and eliminating residual cancer cells that are drivers of recurrence. This June, based on the profound survival benefit observed in the treatment of front-line disease, the FDA approved an additional indication for Blincito for the treatment of adult and pediatric patients one month or older with CD19 positive, Philadelphia chromosome negative, B cell ALL in the consolidation phase of treatment here regardless of minimal residual disease status. We continue to seek to expand the impact of Blin CITO in newly diagnosed BALL through ongoing studies and with the further investigation of subcutaneous administration.

Jay Bradner: Notably, IMDELLTRA is the first bispecific T-cell engager approved to treat a common solid tumor. The present study of tarlatamab in earlier lines and in the context of lower tumor burden, draws from our experience with our first approved bispecific T-cell engager BLINCYTO and B-cell acute lymphoblastic leukemia. Here, we observed a dramatic improvement in overall survival in minimal residual disease negative patients, along with improved tolerability. These BLINCYTO data provide evidence that directing the T cell in this manner is an effective means of finding and eliminating residual cancer cells that are drivers of occurrence.

James Bradner: Here, we observed a dramatic improvement in overall survival in minimal residual disease negative patients along with improved tolerability. These Blinn-Saito data provide evidence that directing the T-cell in this manner is an effective means of finding and eliminating residual cancer cells that are drivers of recurrence. This June, based on the profound survival benefit observed in the treatment of front-line disease, the FDA approved an additional indication for Blincito for the treatment of adult and pediatric patients one month or older with CD19 positive, Philadelphia chromosome negative, B cell ALL in the consolidation phase of treatment here regardless of minimal residual disease status. We continue to seek to expand the impact of Blin CITO in newly diagnosed BALL through ongoing studies and with the further investigation of subcutaneous administration.

Jay Bradner: This June, brd on the profound survival benefit observed in the treatment of frontline disease, the FDA approved an additional indication for BLINCYTO for the treatment of adult and pediatric patients one month or older with CD19 positive, Philadelphia chromosome negative, B-cell ALL and the consolidation phase of treatment, here regardless of minimal residual disease status.

Jay Bradner: Our first-in-class STEAP1 CD3 bispecific molecule, xaluritamig, has also demonstrated profound clinical activity in metastatic castrate-resistant prostate cancer, importantly, demonstrating our ability to target a second common solid tumor with a bispecific T-cell engager therapy. We are rapidly advancing this program and have now fully enrolled the monotherapy Phase I dose expansion as we continue to enroll patients in reduced monitoring and outpatient cohorts. Further, we are advancing the study of xaluritamig earlier in the prostate cancer treatment paradigm with combinations of xaluritamig and enzalutamide or abiraterone ongoing while we plan additional studies in earlier disease settings. In sum, with regard IMDELLTRA, BLINCYTO, xaluritamig as major advances, further establishing the broad potential of our leading bispecific T cell engager platform. To round out oncology, we have completed enrollment of FORTITUDE-101, a Phase III study of bemarituzumab, a first-in-class fibroblast growth factor receptor IIb directed monoclonal antibody administered in combination with chemotherapy in frontline gastric cancer.

James Bradner: Our first-in-class STEEP1 CD3 bispecific molecule, zaliridamig, has also demonstrated profound clinical activity in metastatic, castrate-resistant prostate cancer, importantly demonstrating our ability to target a second common solid tumor with a bispecific T-cell engager therapy. We are rapidly advancing this program and have now fully enrolled the monotherapy phase one dose expansion as we continue to enroll patients in reduced monitoring and outpatient cohorts. Furthermore, we are advancing the study of xaliridamide earlier in the prostate cancer treatment paradigm, with combinations of xaliridamide and enzalutamide or abiraterone ongoing, while we plan additional studies in earlier disease settings. In sum, we regard Indeltra, Blencito, and Dalaritamig as major advances, further establishing the broad potential of our leading bispecific T cell engager platform. To round out oncology, we have completed enrollment in Fortitude 101, a Phase 3 study of bimerituzumab, a first-in-class fibroblast growth factor receptor 2B-directed monoclonal antibody administered in combination with chemotherapy in front

Jay Bradner: In sum, with regard IMDELLTRA, BLINCYTO, xaluritamig as major advances, further establishing the broad potential of our leading bispecific T cell engager platform. To round out oncology, we have completed enrollment of FORTITUDE-101, a Phase III study of bemarituzumab, a first-in-class fibroblast growth factor receptor IIb directed monoclonal antibody administered in combination with chemotherapy in frontline gastric cancer.

James Bradner: In sum, we regard Indeltra, Blencito, and Dalaritamig as major advances, further establishing the broad potential of our leading bispecific T cell engager platform. To round out oncology, we have completed enrollment in Fortitude 101, a Phase 3 study of bimerituzumab, a first-in-class fibroblast growth factor receptor 2B-directed monoclonal antibody administered in combination with chemotherapy in front We are also rapidly advancing AMG-193, our oral PRMT5 inhibitor developed for MTAP-null solid tumors as both monotherapy and in combination with other therapies. Additional data from the Phase I Dose Escalation and Initial Dose Expansion Study of AMG193 in patients with MTAP-null solid tumors will be presented at ESMO in September.

In sum, we regard Indeltra, Blencito, and Dalaritamig as major advances, further establishing the broad potential of our leading bispecific T cell engager platform. To round out oncology, we have completed enrollment in Fortitude 101, a Phase 3 study of bimerituzumab, a first-in-class fibroblast growth factor receptor 2B-directed monoclonal antibody administered in combination with chemotherapy in front

Jay Bradner: We are also rapidly advancing AMG 193, our oral PRMT5 inhibitor developed for MTAP-null solid tumors as both a monotherapy and in combination with other therapies. Additional data from the Phase I dose escalation and initial dose expansion study of AMG 193 in patients with MTAP-null solid tumors will be presented at ESMO in September. Lastly, we are pleased also to share that the FDA has granted an orphan drug designation to AMG 193 for the treatment of pancreatic cancer. Turning to inflammation. We are encouraged by the data arising from our Phase II study of TEZSPIRE in patients with moderate to very severe COPD. Together with AstraZeneca, we are actively planning for Phase III development in COPD. We are also pleased to announce that the FDA recently granted TEZSPIRE, a Breakthrough Therapy Designation as an add-on maintenance treatment of patients with moderate to very severe COPD, characterized by the eosinophilic phenotype. Beyond COPD, we continue to explore TEZSPIRE in separate Phase III studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top line data are expected later this year.

James Bradner: Lastly, we are pleased to share that the FDA has granted an orphan drug designation to AMG-193 for the treatment of pancreatic cancer. Turning to inflammation, we are encouraged by the data arising from our Phase 2 study of Tespire in patients with moderate to very severe COPD. Together with AstraZeneca, we are actively planning for Phase 3 development of COPD. We are also pleased to announce that the FDA recently granted Tespire breakthrough therapy designation as an add-on maintenance treatment for patients with moderate to very severe COPD, characterized by the eosinophilic phenotype. Beyond COPD, we continue to explore test fire in separate phase three studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top-line data are expected later this year.

Jay Bradner: Turning to inflammation. We are encouraged by the data arising from our Phase II study of TEZSPIRE in patients with moderate to very severe COPD. Together with AstraZeneca, we are actively planning for Phase III development in COPD. We are also pleased to announce that the FDA recently granted TEZSPIRE, a Breakthrough Therapy Designation as an add-on maintenance treatment of patients with moderate to very severe COPD, characterized by the eosinophilic phenotype. Beyond COPD, we continue to explore TEZSPIRE in separate Phase III studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top line data are expected later this year.

James Bradner: Beyond COPD, we continue to explore test fire in separate phase three studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top-line data are expected later this year. Now, turning to rocatinlamab, a first-in-class T-cell rebalancing monoclonal antibody targeting the OX40 receptor. The comprehensive rocatinlamab Phase III rocket program has successfully enrolled over 3,100 patients with moderate to severe atopic dermatitis. Five of the eight studies are now fully enrolled.

Beyond COPD, we continue to explore test fire in separate phase three studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top-line data are expected later this year.

Jay Bradner: Turning to rocatinlimab, a first-in-class T cell rebalancing monoclonal antibody targeting the OX40 receptor. The comprehensive rocatinlimab Phase III ROCKET program has successfully enrolled over 3,100 patients with moderate to severe atopic dermatitis. Five of the eight studies are now fully enrolled. The Phase III HORIZON study, part of this ROCKET program evaluates rocatinlimab monotherapy versus placebo in adults with moderate to severe atopic dermatitis. And it is ongoing with data readout anticipated in H2. Beyond atopic dermatitis, we continue to explore the potential of rocatinlimab in additional indications and have initiated a Phase II study in moderate to severe asthma as well as a Phase III study in prurigo nodularis. Shifting to rare disease, we are encouraged by the advancements of our rare disease pipeline with several mid- to late-stage opportunities. UPLIZNA, a CD19 B-cell depleting therapy offers a differentiated mechanism of action than other autoimmune therapies, durable efficacy with a convenient every six-month IV dosing schedule. This could be very important for chronic inflammatory diseases.

James Bradner: The Phase 3 Horizon Study, part of this ROCKIT program, evaluates ropetinlamib monotherapy versus placebo in adults with moderate to severe atopic dermatitis. Shifting to rare diseases, we are encouraged by the advancements in our rare disease pipeline with several mid to late stage opportunities. Aplizna, a CD19 B-cell depleting therapy, offers a differentiated mechanism of action than other autoimmune therapies, durable efficacy with a convenient every six month IV dosing schedule. Recently, we were excited to announce positive top-line results from a Phase III clinical trial evaluating the efficacy and safety of oplizuna for the treatment of immunoglobulin G4-related disease.

The Phase 3 Horizon Study, part of this ROCKIT program, evaluates ropetinlamib monotherapy versus placebo in adults with moderate to severe atopic dermatitis. Shifting to rare diseases, we are encouraged by the advancements in our rare disease pipeline with several mid to late stage opportunities. Aplizna, a CD19 B-cell depleting therapy, offers a differentiated mechanism of action than other autoimmune therapies, durable efficacy with a convenient every six month IV dosing schedule.

Jay Bradner: Beyond atopic dermatitis, we continue to explore the potential of rocatinlimab in additional indications and have initiated a Phase II study in moderate to severe asthma as well as a Phase III study in prurigo nodularis. Shifting to rare disease, we are encouraged by the advancements of our rare disease pipeline with several mid- to late-stage opportunities. UPLIZNA, a CD19 B-cell depleting therapy offers a differentiated mechanism of action than other autoimmune therapies, durable efficacy with a convenient every six-month IV dosing schedule. This could be very important for chronic inflammatory diseases.

Jay Bradner: Shifting to rare disease, we are encouraged by the advancements of our rare disease pipeline with several mid- to late-stage opportunities. UPLIZNA, a CD19 B-cell depleting therapy offers a differentiated mechanism of action than other autoimmune therapies, durable efficacy with a convenient every six-month IV dosing schedule. This could be very important for chronic inflammatory diseases.

Jay Bradner: Recently, we were excited to announce positive top line results from a Phase III clinical trial evaluating the efficacy and safety of UPLIZNA for the treatment of immunoglobulin G4-related disease. The trial met its primary endpoint, showing an astonishing 87% reduction in the risk of IGG4-related disease flare, as compared to placebo during the 52-week placebo-controlled window. All key secondary endpoints were also met and no new safety signals were identified. This is the first randomized controlled trial to demonstrate efficacy in the IgG4-related disease patient population. Regulatory filing activities are underway and full data from the trial will be presented at a future medical meeting. We are also studying a UPLIZNA in generalized myasthenia gravis through the ongoing Phase III MINT study. The MINT study is evaluating the efficacy and safety of UPLIZNA in patients with generalized myasthenia gravis, who are of a comparable disease severity and a comparable treatment experience to other recently approved biologic therapies. We are investigating UPLIZNA in the two predominant antibody serotypes that drive this disease, acetylcholine receptor positive and in muscle specific tyrosine kinase positive patients.

James Bradner: The trial met its primary endpoint, showing an astonishing 87% reduction in the risk of IgG4-related disease flare as compared to placebo during the 52-week placebo-controlled window. All key secondary endpoints were also met, and no new safety signals were identified.

Jay Bradner: We are also studying a UPLIZNA in generalized myasthenia gravis through the ongoing Phase III MINT study. The MINT study is evaluating the efficacy and safety of UPLIZNA in patients with generalized myasthenia gravis, who are of a comparable disease severity and a comparable treatment experience to other recently approved biologic therapies. We are investigating UPLIZNA in the two predominant antibody serotypes that drive this disease, acetylcholine receptor positive and in muscle specific tyrosine kinase positive patients.

James Bradner: We are also studying Eplizna in generalized myasthenia gravis through the ongoing Phase 3 MINT study. The MINT study is evaluating the efficacy and safety of Eplizna in patients with generalized myasthenia gravis who have a comparable disease severity and a comparable treatment experience to other recently approved biologic therapies. We will have more to say about these programs in due course. Lastly, in May, the FDA approved Bikambi as the first interchangeable biosimilar to cilirus or ecolizumab, in this portfolio of potential first-in-class and best-in-class medicines.

We are also studying Eplizna in generalized myasthenia gravis through the ongoing Phase 3 MINT study. The MINT study is evaluating the efficacy and

Jay Bradner: MINT is the only trial attempting to demonstrate efficacy while removing the treatment benefit of steroids. Patients in the MINT trial who entered on steroids had a protocol specified taper by 24 weeks. We look forward to data readout in the second half of 2024. To expand the impact of our CD19 directed therapeutics to even more patients suffering from serious inflammatory diseases, compelled by both biological inferences and insights from small studies of CD19-directed therapies, we are launching a development program targeting CD19 positive B cell-mediated autoimmune disease with UPLIZNA and blinatumomab. This is an exciting and promising space with Amgen's strong capabilities in inflammatory disease and two well-characterized assets, we are very well positioned to lead in this rapidly advancing field. We will have more to say about these programs in due course. Lastly, in May, the FDA approved BEKEMV as the first interchangeable biosimilar to Soliris or eculizumab. Also in biosimilar development, registration-enabling studies are underway for ABP 234 and a biosimilar candidate to KEYTRUDA and ABP 206, a biosimilar candidate to OPDIVO.

Jay Bradner: This is an exciting and promising space with Amgen's strong capabilities in inflammatory disease and two well-characterized assets, we are very well positioned to lead in this rapidly advancing field. We will have more to say about these programs in due course.

Jay Bradner: Lastly, in May, the FDA approved BEKEMV as the first interchangeable biosimilar to Soliris or eculizumab. Also in biosimilar development, registration-enabling studies are underway for ABP 234 and a biosimilar candidate to KEYTRUDA and ABP 206, a biosimilar candidate to OPDIVO.

Jay Bradner: In closing, I'd like to thank my Amgen colleagues for their strong sense of service to patients facing serious illness, their intense focus and spirited collaboration during this momentous year and their commitment to growing the impact of both our research and our business through this portfolio of potential first-in-class and best-in-class medicines. I'll now turn it over to Peter.

Peter H. Griffith: Thank you, Jay. We're pleased with our strong second quarter performance and are on track with our 2024 full year goals and long-term objectives. We have a strong long-term growth outlook across our four therapeutic areas, driven by the breadth and depth of our innovative pipeline and in-market products, serving patients with serious illnesses around the globe. Starting with our second quarter results, as shown on Slide 27 of the slide deck, we delivered $8.4 billion in total revenue, a 20% increase year-over-year. It's the highest quarterly revenue in Amgen history, achieved with 26% volume growth. This means more patients than ever are receiving Amgen medicines. Excluding the addition of Horizon, product sales increased 5% year-over-year, driven by 10% volume growth. In the second quarter, we delivered a non-GAAP operating margin of 48.2% as a percentage of product sales with total non-GAAP operating expenses increasing 30% year-over-year. Non-GAAP cost of sales as a percent of product sales increased 0.4 percentage points on a year-over-year basis, primarily driven by higher royalties and profit share due to changes in sales mix.

Peter H. Griffith: Starting with our second quarter results, as shown on Slide 27 of the slide deck, we delivered $8.4 billion in total revenue, a 20% increase year-over-year. It's the highest quarterly revenue in Amgen history, achieved with 26% volume growth. This means more patients than ever are receiving Amgen medicines. Excluding the addition of Horizon, product sales increased 5% year-over-year, driven by 10% volume growth. In the second quarter, we delivered a non-GAAP operating margin of 48.2% as a percentage of product sales with total non-GAAP operating expenses increasing 30% year-over-year. Non-GAAP cost of sales as a percent of product sales increased 0.4 percentage points on a year-over-year basis, primarily driven by higher royalties and profit share due to changes in sales mix.

Peter Griffith: Excluding the addition of Horizon, product sales increased 5% year-over-year driven by 10% volume growth. Non-GAAP SG&A expenses increased 36% year-over-year, primarily driven by the addition of Horizon. Excluding the addition of Horizon, non-GAAP SG&A expenses increased 14% year-over-year, driven by investment in Repatha, Otesla, and Avenity. Our non-GAAP tax rate decreased 1.5 percentage points year-over-year to 14.9%.

Excluding the addition of Horizon, product sales increased 5% year-over-year driven by 10% volume growth.

Peter H. Griffith: In the second quarter, we delivered a non-GAAP operating margin of 48.2% as a percentage of product sales with total non-GAAP operating expenses increasing 30% year-over-year. Non-GAAP cost of sales as a percent of product sales increased 0.4 percentage points on a year-over-year basis, primarily driven by higher royalties and profit share due to changes in sales mix.

Peter H. Griffith: Non-GAAP R&D spending in the second quarter increased 30% year-over-year as we strategically invested in the late-stage pipeline, including MariTide, rocatinlimab and bemarituzumab as well as Horizon acquired programs. Non-GAAP SG&A expenses increased 36% year-over-year, primarily driven by the addition of Horizon. Excluding the addition of Horizon, non-GAAP SG&A expenses increased 14% year-over-year, driven by investment in REPATHA, OTEZLA and EVENITY. Our non-GAAP OI&E resulted in a $700 million expense, up $400 million year-over-year, almost entirely due to increased interest expenses from the Horizon acquisition. We remain on track to deleverage with line of sight to retiring greater than $10 billion of debt by the end of 2025. This includes $1.4 billion of debt retired in the second quarter and $2.0 billion year-to-date. Our non-GAAP tax rate decreased 1.5 percentage points year-over-year to 14.9%, primarily due to the change in sales mix from the inclusion of our Horizon.

Peter H. Griffith: In the second quarter of 2024, the Company generated $2.2 billion of free cash flow, a decrease of $3.8 billion--a decrease from $3.8 billion in the previous year, driven by the timing of tax payments. In 2023, federal tax payments, including our repatriation tax were made in the fourth quarter, whereas in 2024, these payments were made in the second quarter. The Horizon integration is progressing well, and we expect to reach $500 million in pretax synergies by year three post acquisition, with roughly 50% to be realized by the end of this year. We expect accretion to non-GAAP earnings per share in 2024. We continue to execute on our capital allocation priorities. We're investing in the best innovation, both internally and externally, to rapidly advance an innovative pipeline, multiple potentially first-in-class and/or best-in-class medicines across the four therapeutic areas. As I said earlier, this is reflected in our second quarter non-GAAP R&D spend of $1.4 billion, an increase of 30% year-over-year.

Peter H. Griffith: Second, we continue investing in our business for long-term growth. We are expanding capacity in our state-of-the-art manufacturing facilities, including investments to support MariTide. Beyond manufacturing, we are opening a new global technology and innovation center in Hyderabad, India, which will attract talent at scale and accelerate digital capabilities across the organization, including artificial intelligence, data science, life science and medical. And third, we returned capital to shareholders as we paid competitive dividends of $2.25 per share in the second quarter. This represented a 6% increase compared to 2023. Turning to the outlook for the business for 2024 on Slide 29. We expect our 2024 total revenues in the range of $32.8 billion to $33.8 billion in non-GAAP earnings per share between $19.10 and $20.10. I will mention a few considerations as you model the remainder of 2024. On revenues, we expect mid-single-digit growth, quarter-over-quarter in the fourth quarter compared to Q3. Our full year non-GAAP R&D expenses are now expected to increase more than 25% year-over-year as we further invest in our late-stage pipeline to support multiple late-stage studies underway across all therapeutic areas. As a result, we now project the full year non-GAAP operating margin as a percentage of product sales to be roughly 47% with Q3 operating margin lower than Q2.

Peter Griffith: Turning to the outlook for the business for 2024 on slide 29, we expect our 2024 total revenues to be in the range of $32.8 to $33.8 billion, with non-GAAP earnings per share between $19.10 and $20.10. I will mention a few considerations as you model the remainder of 2024. On revenues, we expect mid single-digit growth quarter over quarter in the fourth quarter compared to Q3. As a result, we now project the full year non-GAAP operating margin as a percentage of product sales to be roughly 47%, with the Q3 operating margin lower than Q2.

Peter H. Griffith: Turning to the outlook for the business for 2024 on Slide 29. We expect our 2024 total revenues in the range of $32.8 billion to $33.8 billion in non-GAAP earnings per share between $19.10 and $20.10. I will mention a few considerations as you model the remainder of 2024. On revenues, we expect mid-single-digit growth, quarter-over-quarter in the fourth quarter compared to Q3. Our full year non-GAAP R&D expenses are now expected to increase more than 25% year-over-year as we further invest in our late-stage pipeline to support multiple late-stage studies underway across all therapeutic areas. As a result, we now project the full year non-GAAP operating margin as a percentage of product sales to be roughly 47% with Q3 operating margin lower than Q2.

Peter Griffith: On revenues, we expect mid single-digit growth quarter over quarter in the fourth quarter compared to Q3. As a result, we now project the full year non-GAAP operating margin as a percentage of product sales to be roughly 47%, with the Q3 operating margin lower than Q2. Total non-GAAP operating expenses for the third quarter are expected to grow at a similar rate to the first two quarters of this year. This concludes our financial update.

On revenues, we expect mid single-digit growth quarter over quarter in the fourth quarter compared to Q3. As a result, we now project the full year non-GAAP operating margin as a percentage of product sales to be roughly 47%, with the Q3 operating margin lower than Q2.

Peter H. Griffith: Total non-GAAP operating expenses for the third quarter are expected to grow at a similar rate to the first two quarters of this year. We expect OI&E to be approximately $2.5 billion, which includes the interest expense related to the $28 billion of debt raised for the Horizon acquisition. We continue to expect the non-GAAP tax rate to be in the 15% to 16% range, including the full year benefits associated with the inclusion of the Horizon business. As we have previously indicated, we have initiated activities to further expand MariTide manufacturing capacity. To support these initial efforts, we now expect capital expenditures of $1.3 billion in 2024 versus our most recent guidance of $1.1 billion to $1.2 billion. Our long-term outlook remains robust, and I am grateful to our 27,000-plus colleagues worldwide for their dedication to serve patients. This concludes our financial update. We will now begin our Q&A session. Julianne, please remind our participants of the process. Thank you.

Peter H. Griffith: To support these initial efforts, we now expect capital expenditures of $1.3 billion in 2024 versus our most recent guidance of $1.1 billion to $1.2 billion. Our long-term outlook remains robust, and I am grateful to our 27,000-plus colleagues worldwide for their dedication to serve patients. This concludes our financial update. We will now begin our Q&A session. Julianne, please remind our participants of the process. Thank you.

Operator: Thank you. If you would like to ask a question, please press star followed by 1 on your telephone keypad. If for any reason you would like to remove that question, please press star followed by 1. Again, to ask a question, press star 1. Our first question comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open.

Yaron Werber: Great. Thank you, very nice result. Thanks so much. Jay, maybe a question for you, actually. I want to start with the UPLIZNA. And we noticed a few things. The MINT study was supposed to have completion around mid-May. And Amgen just posted a whole bunch of new job postings for GMJ and you have a slot on October 15 at the MGFA to present the data. As you noted, you're doing steroid tapering. It's a different trial design but you also did steroid tapering and the other two indications, NMO and IGG4. Can you talk a little bit sort of what are you hoping to see and what are you expecting to see from the data? Thank you.

Jay Bradner: Thank you, Yaron, for the question, and for following the program so closely. We're very excited about UPLIZNA, the CD19 B-cell depleting monoclonal antibody is showing really remarkable activity, the results in IGG4-related disease is a bellwether and is quite dramatic with a hazard ratio of 0.13, a P value of what, five to the minus seven. This was a stunning result and the first positive Phase III for patients with IGG4-related diseases. As you nicely picked up in your question, one of the opportunities of UPLIZNA is to get patients off steroids, and this is, therefore, a predefined ambition of UPLIZNA in both IGG4-related disease setting in that study as well, as in the generalized myasthenia gravis setting. Now these results won't be available until the second half of this year. And so I have no further update on that timing. But do stay tuned. We're so hopeful that this once every six months CD19 B-cell depleting therapy can differentiate substantially from available treatments like steroids and other B-cell targeting therapies and make a big difference for these patients.

Robert A. Bradway: Julianne, let's go to the next question. Thank you, Yaron. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead. Your line is open.

Unknown: Julianne, let's go to the next question.

Operator: Thank you, Yaron. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead. Your line is open.

Salveen Richter: Good afternoon, thanks for taking my question. Just following up here on Yaron, could you speak to the clinical bar for UPLIZNA and myasthenia gravis, both on a placebo-adjusted basis and also on an absolute basis, given the notable steroid taper, which I believe the other therapies did not have included in their design. And with regard to this MGFA scientific session meeting, should we expect top line results before that presentation? Thank you. Thanks, Salveen. As I just mentioned to Yaron, we won't be providing further guidance on the timing of the results from the UPLIZNA study, the MINT study in myasthenia gravis of that you stay tuned. And as also, as shared knowing that patients with myasthenia gravis are repeatedly and over many, many months of treatment challenge by the requirement for persistent steroids, we built in a taper steroids on to this study. And these results to read out in the second half of this year will bring to light exactly how successful we are at liberating patients from steroids with every six months UPLIZNA.

Jay Bradner: Thanks, Salveen. As I just mentioned to Yaron, we won't be providing further guidance on the timing of the results from the UPLIZNA study, the MINT study in myasthenia gravis of that you stay tuned. And as also, as shared knowing that patients with myasthenia gravis are repeatedly and over many, many months of treatment challenge by the requirement for persistent steroids, we built in a taper steroids on to this study. And these results to read out in the second half of this year will bring to light exactly how successful we are at liberating patients from steroids with every six months UPLIZNA. Julianne, go to the next question, please.

Unknown: Julianne, go to the next question, please.

Operator: Thank you, Salveen. Our next question comes from Evan Seigerman from BMO Capital Markets. Please go ahead. Your line is open. Well, not a huge growth driver. I'd love if you could characterize on some of your negotiations with CMS on Enbrel. Many of your peers are pleased with kind of the fair price that they negotiated with CMS. Do you feel the same way? I'd also love to know how you're seeing about the impact of Part D redesign?

Operator: Thank you, Salveen. Our next question comes from Evan Seigerman from BMO Capital Markets. Please go ahead. Your line is open.

Evan Seigerman: Hi, thank you so much for taking my question. Well, not a huge growth driver. I'd love if you could characterize on some of your negotiations with CMS on ENBREL. Many of your peers are pleased with kind of the fair price that they negotiated with CMS. Do you feel the same way? I'd also love to know how you're seeing about the impact of Part D redesign? Thank you so much. Thanks, Evan, for the question. It's Murdo here. Overall, ENBREL continues to do well in the market despite a very competitive market in psoriatic arthritis and in rheumatoid arthritis. We also continue to have relatively stable volume despite all of the conversion that's going on in adalimumab with biosimilars. So we're quite pleased with prescribers adoption and continued value of ENBREL safety and tolerability, which is well established over a long period of time now in many, many years of experience. The process with CMS has concluded. We do have our price. I would just remind you that roughly 25% of ENBREL revenues come from Medicare Part D. So that will, in part, mitigate the impact of the CMS price reduction. And we continue to see that this is not a good mechanism to incentivize and reward innovation and it does not resemble one we've commonly described as a negotiation. So we've concluded that process. And we continue to look to help patients and support them with ENBREL in the market and we will watch the Part D redesign closely. We will look to see how PBMs redesign their formularies, and we will look to see how patients are impacted by the new model. While the cap may help, the out-of-pocket for many patients may actually rise. So we're watching it closely.

Murdo Gordon: Thanks, Evan, for the question. It's Murdo here. Overall, ENBREL continues to do well in the market despite a very competitive market in psoriatic arthritis and in rheumatoid arthritis. We also continue to have relatively stable volume despite all of the conversion that's going on in adalimumab with biosimilars. So we're quite pleased with prescribers adoption and continued value of ENBREL safety and tolerability, which is well established over a long period of time now in many, many years of experience. The process with CMS has concluded. We do have our price. I would just remind you that roughly 25% of ENBREL revenues come from Medicare Part D. So that will, in part, mitigate the impact of the CMS price reduction. And we continue to see that this is not a good mechanism to incentivize and reward innovation and it does not resemble one we've commonly described as a negotiation. So we've concluded that process. And we continue to look to help patients and support them with ENBREL in the market and we will watch the Part D redesign closely. We will look to see how PBMs redesign their formularies, and we will look to see how patients are impacted by the new model. While the cap may help, the out-of-pocket for many patients may actually rise. So we're watching it closely. Julianne, next question, please.

Murdo Gordon: And we continue to see that this is not a good mechanism to incentivize and reward innovation and it does not resemble one we've commonly described as a negotiation. So we've concluded that process. And we continue to look to help patients and support them with ENBREL in the market and we will watch the Part D redesign closely. We will look to see how PBMs redesign their formularies, and we will look to see how patients are impacted by the new model. While the cap may help, the out-of-pocket for many patients may actually rise. So we're watching it closely.

Robert A. Bradway: Julianne, next question, please. Thank you, Evan. Our next question comes from Mike Yee from Jefferies. Please go ahead. Your line is open.

Unknown: Julianne, next question, please.

Operator: Thank you, Evan. Our next question comes from Mike Yee from Jefferies. Please go ahead. Your line is open. one

Operator: Thank you, Evan. Our next question comes from Mike Yee from Jefferies. Please go ahead. Your line is open.

Michael J. Yee: Thank you for the question. Pivoting to obesity. I know that you are on track for data later this year for the injectable product, which you claim as differentiated as other competitors have moved quickly, both with their programs with injectables but also oral multiple companies are putting off. Can you just comment about how you feel about your positioning in this space, given others have multiple products moving to late stage and how you feel you can position yourself here, given just 133. Thank you. One.

Jay Bradner: Thanks, Mike. Why don't I get started and Murdo, perhaps you could add on at the end. We are very pleased with the results that we've seen at the interim with the overall conduct of the Phase II study. Though there's been no further analysis since the interim, as of the interim all the arms were active, dropout had not been an issue. And we saw a differentiated profile with MariTide and remain confident that this medicine can address significant important unmet medical need in obesity, obesity-related conditions and, in particular, type 2 diabetes, as shared earlier in the call. There's no question that there is quite a democratized and broad base of innovation in this space. And potentially oral medicines could serve to address some of that still vast and remaining unmet need, and we follow these programs very closely. Still, the development of MariTide is advancing very briskly, as we now move to rapidly initiate a broad Phase III program. And we remain confident in what MariTide can offer for patients with obesity-related conditions as well as diabetes. Murdo?

Unknown Executive: Thanks, Mike. Why don't I get started, and Murdo, perhaps you could add on at the end? You know, we are very pleased with the results that we've seen at the interim and with the overall conduct of the phase two study. Though there's been no further analysis since the interim, as of the interim, all the arms were active, dropout had not been an issue, and we saw a differentiated profile with Meritide and remain confident that this medicine can address significant important needs in that medical need and obesity, obesity-related conditions, and in particular type 2 diabetes, as shared earlier in the call. There's no question that there is quite a democratized and broad base of innovation in this space, and potentially, oral medicines could serve to address some of that still vast and remaining unmet need, and we follow these programs very closely. Still, the development of Meritide is advancing very briskly as we now move to rapidly initiate a broad phase three program, and we remain confident in what Meritide can offer for patients with obesity-related conditions as well as diabetes and myeloma.

Unknown Executive: You know, we are very pleased with the results that we've seen at the interim and with the overall conduct of the phase two study. Though there's been no further analysis since the interim, as of the interim, all the arms were active, dropout had not been an issue, and we saw a differentiated profile with Meritide and remain confident that this medicine can address significant important needs in that medical need and obesity, obesity-related conditions, and in particular type 2 diabetes, as shared earlier in the call. There's no question that there is quite a democratized and broad base of innovation in this space, and potentially, oral medicines could serve to address some of that still vast and remaining unmet need, and we follow these programs very closely. Still, the development of Meritide is advancing very briskly as we now move to rapidly initiate a broad phase three program, and we remain confident in what Meritide can offer for patients with obesity-related conditions as well as diabetes and myeloma.

Unknown Executive: There's no question that there is quite a democratized and broad base of innovation in this space, and potentially, oral medicines could serve to address some of that still vast and remaining unmet need, and we follow these programs very closely. Still, the development of Meritide is advancing very briskly as we now move to rapidly initiate a broad phase three program, and we remain confident in what Meritide can offer for patients with obesity-related conditions as well as diabetes and myeloma.

Jay Bradner: There's no question that there is quite a democratized and broad base of innovation in this space. And potentially oral medicines could serve to address some of that still vast and remaining unmet need, and we follow these programs very closely. Still, the development of MariTide is advancing very briskly, as we now move to rapidly initiate a broad Phase III program. And we remain confident in what MariTide can offer for patients with obesity-related conditions as well as diabetes. Murdo?

Murdo Gordon: Yes. Thanks, Jay. I think the data continue to emerge in the obesity and obesity-related conditions landscape, and show a clear benefit that reducing weight will indeed--with GLP-1-brd mechanisms will indeed improve outcomes in many disease settings. So that continues to expand the market and grow it. I do agree with Jay that there will be patients who may seek oral options, but I continue to believe that we have a very good, differentiated product here and that monthly dosing, or even less frequently will continue to help patients persist on their weight loss medication and achieve, hopefully, some of those hard endpoint risk reductions that we're seeing in clinical trial presentations. I would say that we would report that we have a really good convenient dosing here with a single-use pen that we're working on. And that weekly injectable products are probably more vulnerable to orals than a convenient monthly dosing. Next question, please, Julianne.

Unknown Executive: I would say that we would purport to have a really good, convenient dosing here with the single-use pen that we're working on and that weekly injectable products are probably more vulnerable to orals than a convenient monthly dosing.

Robert A. Bradway: Next question, please, Julianne. Thank you, Mike. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead, your line is open. One.

Robert A. Bradway: Next question, please, Julianne. Thank you, Mike. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead, your line is open.

Unknown: Next question, please, Julianne.

Operator: Thank you, Mike. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead, your line is open. Hi, guys. Thanks for taking my question. I wanted to focus on MariTide, if I may. A two-part question. First, it looks like your competitors are moving forward to Phase III on either smaller data sets or lesser further along from a Phase II, Phase III perspective. Just curious why you thought you definitely needed 52-week data? Was that mostly conservatism? Or is that some FDA feedback as well? And then also on CapEx, I feel like the $150 million guidance increase seems relatively trivial but it does imply CapEx being up 80% over first half. Could you please expand on whether it's API related or something else you have in mind? Thank you very much.

Operator: Thank you, Mike. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead, your line is open.

Umer Raffat: Hi, guys. Thanks for taking my question. I wanted to focus on MariTide, if I may. A two-part question. First, it looks like your competitors are moving forward to Phase III on either smaller data sets or lesser further along from a Phase II, Phase III perspective. Just curious why you thought you definitely needed 52-week data? Was that mostly conservatism? Or is that some FDA feedback as well? And then also on CapEx, I feel like the $150 million guidance increase seems relatively trivial but it does imply CapEx being up 80% over first half. Could you please expand on whether it's API related or something else you have in mind? Thank you very much. Yes. Thanks. Pete, why don't I start on the overall development plan for MariTide and the value of the Phase II data that we'll have at the end of this year. Umer, as you know, this medicine coming out of Phase I showed a quite remarkable impact on obesity with a dramatic reduction in BMI, actually proved quite durable after just three doses, MariTide in that Phase I study, we saw persistent weight loss really out 150 days or more at some doses. The Phase II study is a much larger concern. This is a 592 patient study. It has 11 arms, it has monthly or as Murdo said, even less frequent dosing. As a part two that allows us to really follow up on this durability signal, and it will allow the precision selection of dose or doses that patients and their practitioners really desire. This also confirms to regulatory requirements entering into Phase III.

Jay Bradner: Yes. Thanks. Pete, why don't I start on the overall development plan for MariTide and the value of the Phase II data that we'll have at the end of this year. Umer, as you know, this medicine coming out of Phase I showed a quite remarkable impact on obesity with a dramatic reduction in BMI, actually proved quite durable after just three doses, MariTide in that Phase I study, we saw persistent weight loss really out 150 days or more at some doses. The Phase II study is a much larger concern. This is a 592 patient study. It has 11 arms, it has monthly or as Murdo said, even less frequent dosing. As a part two that allows us to really follow up on this durability signal, and it will allow the precision selection of dose or doses that patients and their practitioners really desire. This also confirms to regulatory requirements entering into Phase III.

Peter H. Griffith: Umer's Peter on CapEx, as we previously indicated, which was 1.1 to 1.2 billion. Oh, hey, thanks for taking the question.

Peter H. Griffith: Umer, it's Peter on CapEx, as we previously indicated, we have initiated activities to further expand MariTide manufacturing capacity. So of course, those efforts, I said we now expect CapEx of $1.3 billion in '24 versus the most recent guidance, which was $1.1 billion to $1.2 billion. Julianne, next question, please.

Robert A. Bradway: Julianne, next question, please. Thank you, Umer. Our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open.

Unknown: Julianne, next question, please.

Operator: Thank you, Umer. Our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open.

Jay Olson: Oh, hey, thanks for taking the question and congrats on all the progress, especially in your BiTE platform. Can you talk about any feedback you're getting from clinicians on the IMDELLTRA launch, and potential lessons learned from BLINCYTO that you can leverage for IMDELLTRA, especially since you're launching BLINCYTO now in B-ALL and developing a subcu formulation? Thank you.

Robert A. Bradway: Take it in a couple of parts here. Murdo, do you want to share what we're learning from the launch?

Murdo Gordon: Yes. Thanks for the question, Jay. Obviously, it's very early given that this was a mid-May approval but I have to say we are extremely pleased with how both thought leaders and community oncologists are receiving IMDELLTRA in the market. Their clinical conviction is very high. They are moving quickly to establish care pathways for these patients given the monitoring requirement for IMDELLTRA. And this is--this disease setting, as you know, is a really difficult disease setting. Patients can progress relatively rapidly after platinum-based chemotherapy in the front line. And so we're obviously moving very quickly with our medical teams, our account management teams and our sales organization to build rapid awareness and to help both academic and community oncology accounts, be able to treat patients easily and safely and have the appropriate settings for care follow-up. So very early, but this product is seen as a major transformation in this disease setting. Jay?

Murdo Gordon: They are moving quickly to establish care pathways for these patients, given the monitoring requirement for MDELTRA, and this disease setting, as you know, is a really difficult disease setting. Patients can progress relatively rapidly after platinum-based chemotherapy on the front line, and so we're obviously moving very quickly with our medical teams, our account management teams, and our sales organization to build rapid awareness and to help both academic and community oncology accounts be able to treat patients easily and safely and have the appropriate settings for care follow-up. So, it is very early, but this product is seen as a major transformation in this disease setting. Jay? Yeah, no. Thanks for the question, Jay.

They are moving quickly to establish care pathways for these patients, given the monitoring requirement for MDELTRA, and this disease setting, as you know, is a really difficult disease setting. Patients can progress relatively rapidly after platinum-based chemotherapy on the front line, and so we're obviously moving very quickly with our medical teams, our account management teams, and our sales organization to build rapid awareness and to help both academic and community oncology accounts be able to treat patients easily and safely and have the appropriate settings for care follow-up. So, it is very early, but this product is seen as a major transformation in this disease setting. Jay?

Jay Bradner: Yes. Thanks for the question, Jay. You picked up on something really interesting and that's leveraging the learnings of BLINCYTO. I mean this really is a platform capability that we enjoy with bispecific T-cell engagers. And already in the development of IMDELLTRA after its first approval, we are seeing significant readthrough of the BLINCYTO lessons, moving from later lines of therapy to earlier lines of therapy, to drive efficacy in the setting of reduced tumor burden. The utility of these medicines in combination, which is so much easier to access and assess than other complex modalities, say, like CAR-T and moving these medicines to the point of therapy where they can have the greatest impact, namely frontline, also pathways to reduce monitoring. Jay, we are leveraging all the learnings of BLINCYTO to drive and expedite the development of IMDELLTRA to be a component of frontline small cell lung cancer therapy, both with extensive stage and limited stage disease. And as Murdo shared, we do this work really quite inspired by the impact of the medicine, even so early in its launch, significant demand to learn and access and offer this medicine.

Unknown Executive: You picked up on something really interesting, and that's, you know, leveraging the learnings of Blinn-Saito. This really is a platform capability that we enjoy with bi-specific T-cell engagers. And already, in the development of mDeltra after its first approval, we are seeing significant reading through of the Blinn-Saito lessons to drive efficacy in the setting of reduced tumor burden. The utility of these medicines in combination, which is so much easier to access and assess than other complex modalities, say like CAR-T, and moving these medicines to the point of therapy where they can have their greatest impact, namely frontline, also pathways to reduce monitoring. Jay, we are leveraging all the learnings of Lin-Syto to drive and expedite the development of Imdeltra to be a component of frontline small cell lung cancer therapy for both extensive stage and limited stage disease. And as Myrtle shared, we do this work really quite inspired by the impact of the medicine even so early in its launch, significant demand to learn, access, and offer this medicine.

Unknown Executive: Jay, we are leveraging all the learnings of Lin-Syto to drive and expedite the development of Imdeltra to be a component of frontline small cell lung cancer therapy for both extensive stage and limited stage disease. And as Myrtle shared, we do this work really quite inspired by the impact of the medicine even so early in its launch, significant demand to learn, access, and offer this medicine.

Robert A. Bradway: And Jay, I'd just add that when it comes to xaluritamig, I think you're question applies well there, too. So stay tuned. We'll talk more about xaluritamig's data emerge but we're optimistic about how we can apply the lessons of BLIN and IMDELLTRA to that as well. Let's go to the next question.

Operator: Thank you, Jay. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead, your line is open. One.

Operator: Thank you, Jay. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead, your line is open. Great, thank you very much for taking my question. I have a question for Jay. Again, on MariTide. Is there any reason to think that MariTide may or may not exhibit a different profile versus [inaudible] on parameters such as lipid blood pressure or C-reactive protein? And how important is benefit on those parameters while you design your Phase III trial, something like outcomes trial or not?

Operator: Thank you, Jay. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead, your line is open.

Mohit Bansal: Great, thank you very much for taking my question. I have a question for Jay. Again, on MariTide. Is there any reason to think that MariTide may or may not exhibit a different profile versus [inaudible] on parameters such as lipid blood pressure or C-reactive protein? And how important is benefit on those parameters while you design your Phase III trial, something like outcomes trial or not?

Operator: Thank you, Mohit. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead. Your line is open. Great.

Jay Bradner: Yes. Thank you, Mohit. I can surely understand the interest. And indeed, we are making all these measurements and more. We won't dimensionalize what we mean when we say differentiated profile at this time. We're so focused on completing this ongoing and well-conducted MariTide Phase II study but do expect to learn and listen more when ultimately we're able to be in a position to share the outcomes of Part A of the Phase II study. We are taking a comprehensive assessment to optimize dose and schedule and impact of this medicine. Julianne, next question, please.

Robert A. Bradway: Julianne, next question, please. Thank you, Mohit. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead, your line is open.

Unknown: Julianne, next question, please.

Operator: Thank you, Mohit. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead, your line is open. Oneoneoneone

Operator: Thank you, Mohit. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead, your line is open.

Gregory Renza: Great, thanks. Congratulations on the quarter and thanks for taking my question. My question is just on the obesity franchise. As you and the team had mentioned to expect one of the early obesity programs to enter clinical development later this year. Just curious if you could elaborate on what lens you're using to nominate that first or that next program? I'd imagine it's rather complex in the assessment and any color you have on determining that choice and how to take that forward, would be great. Thank you.

Jay Bradner: Gregory. Thank you. This is Jay, and thanks for following the early pipeline in its development. It's developing very nicely. As we've shared our strategy in the development of obesity medicines and medicines for obesity-related conditions. We're interested in really harvesting the insights of the incretin pathway but also moving beyond this pathway to other novel targets, some supported by genetic inferences but all of them supported by strong preclinical development packages. And so it is a multifactorial assessment that leads to the decision, to resource the medicine in human clinical investigation. But it's a high degree of conviction that's required as the bars are ever rising within our portfolio for that resource as well as in the field. So more to follow on the mechanism and characteristics of this new medicine that we're intending to advance in the clinical investigation in the second half of this year. Right, next question, please.

Unknown: Right, next question, please.

Operator: Thank you, Gregory. Our next question comes from Chris Raymond of Piper Sandler. Please go ahead. Your line is open. Thanks, and, if I may, another obesity question.

Operator: Thank you, Gregory. Our next question comes from Chris Raymond from Piper Sandler. Please go ahead. Your line is open.

Christopher J. Raymond: Thanks. And if I may, another obesity question. Just on MariTide, and I've heard you guys now talk for a long time about planning for a broad Phase III program. But I don't think you guys have ever talked even in generalities, when exactly this will happen. Can you maybe give a range here for when you anticipate kicking off enrollment in that program? Chris, as you can expect...

Robert A. Bradway: Chris, as you can expect, we're focused now on completing the Phase II trial and moving as swiftly as appropriate into Phase III. So we'll have more to say that over the course of the coming year. You can appreciate it's a competitively intense field. So we're not giving dates at this point.

Unknown: Alright guys, next question, please. Our next question comes from Carter Gould from Barclays. Please go ahead, your line is open.

Unknown: Alright guys, next question, please.

Operator: Our next question comes from Carter Gould from Barclays. Please go ahead, your line is open. Hi, thanks

Operator: Our next question comes from Carter Gould from Barclays. Please go ahead, your line is open.

Carter Gould: Good afternoon, thank you for taking the question. For Peter, on August 2nd, the U.S. Tax Court entered a decision against Coke. Their litigation was often referenced as sort of the best benchmark for sort of what you're facing. Appreciating that you took the deposit earlier this year but why shouldn't there be read through from that case? And maybe you could speak to your overall confidence in the outcome. Thank you. Thank you

Peter H. Griffith: No. Thank you very much for the question, Carter. Nothing has changed in our evaluation of the case. Court dates set for November 4. We're confident in our position, right, where we've always been. We're confident in our reserves are at an appropriate level. What I would say is, first of all, I don't see--and Coke hasn't been as much a reference and I won't get into making comparisons. We refer once in a while to the Medtronic situation. But in general, what we've seen is that the tax court in the last several years has reinforced the value of manufacturing down in Puerto Rico. And so we look forward to stating our case. We're very confident where we're at. And that's all we've got to say at this time. No change. We're at where we were in terms of confidence, which is in the same place for the last 2.5 or 3 years now. Julianne, next question, please.

Unknown: Julianne, next question, please. Thank you, Carter. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead, your line is open.

Unknown: Julianne, next question, please.

Operator: Thank you, Carter. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead, your line is open. Great

Operator: Thank you, Carter. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead, your line is open. Great, thanks for taking the question. Peter, another one for you here. I appreciate the incremental guidance on CapEx, but just was wondering if you could speak directionally about margins in 2025, given the likely scope of the MariTide obesity program. Thank you.

Operator: Thank you, Carter. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead, your line is open.

Terence C. Flynn: Great, thanks for taking the question. Peter, another one for you here. I appreciate the incremental guidance on CapEx, but just was wondering if you could speak directionally about margins in 2025, given the likely scope of the MariTide obesity program. Thank you.

Peter H. Griffith: Terence, we don't--as you know, we don't guide long-term margins but let me just comment on what you're seeing this year. I'm happy to speak to that. And I think it's important. At Amgen, we're committed to a capital allocation hierarchy, where we first invest in innovation and first internal innovation. And so with that in mind, Terence, we've consistently said that we would flex out margin, which remember, with us, as a percentage of product sales, not revenue, if there were opportunities to achieve strong after-tax cash returns on our investment in excess of our hurdle rate. And then we would communicate that ahead of time. So this year, we shared with you at the beginning of the year, we felt operating margin to be about 48%. We see an opportunity here during the year to make some investments in the research and development activities with an emphasis, I would say, on development. That's up 30% year-over-year in the quarter, non-GAAP R&D. We now see non-GAAP R&D spend up over 25% year-over-year for '24, which we think is great because you've heard about the deep mid- and late-stage pipeline we have, driving MariTide in that deep mid- and late-stage pipeline. We're always focused Terence, whether it's this year or next year on productivity and prioritization, always looking for opportunities to generate capital to allocate the innovation. We've got a new program called technology and workforce strategy that we're moving along at speed and scale. I spoke about opening a new talent and innovation center in Hyderabad, India. So we are doing everything we can to preserve that margin, reallocate capital innovation and be the disciplined spenders of capital that Amgen always has been.

Peter H. Griffith: We're always focused Terence, whether it's this year or next year on productivity and prioritization, always looking for opportunities to generate capital to allocate the innovation. We've got a new program called technology and workforce strategy that we're moving along at speed and scale. I spoke about opening a new talent and innovation center in Hyderabad, India. So we are doing everything we can to preserve that margin, reallocate capital innovation and be the disciplined spenders of capital that Amgen always has been. All right, next question, please.

Unknown: All right, next question, please.

Operator: All right, next question, please. Thank you, Terence. Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open. Great. Thanks very much. I just had a question on Maritide and your plans for...

All right, next question, please. Thank you, Terence.

Unknown: All right, next question, please.

Operator: Thank you, Terence. Our next question comes from Chris Schott from JPMorgan. Please go ahead. Your line is open.

Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open. Great. Thanks very much. I just had a question on Maritide and your plans for...

Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open.

Chris Schott: Great. Thanks very much. Just had a question on MariTide and your plans in that Phase II diabetes study. Company, obviously, very excited about the broader opportunity for the drug but it does seem like diabetes is a more established market with maybe less of the capacity constraints than we've see in obesity. So can you just talk a little bit about what you think you need to see to be able to compete here in dislodging [inaudible]. And can you also confirm that the study is not needed to move forward in the Phase III obesity studies, or it's just a completely separate program related to the diabetes piece of things? Thank you. One

Robert A. Bradway: Can take this in two pieces again. Jay, why don't you address the first piece and then Murdo feel free to jump in. Yes, absolutely. As you nicely identified later this year, we will initiate an additional dedicated Phase II study that will characterize MariTide from the treatment of diabetes in patients with and without obesity. And this new study is not a gating step at all for the Phase III program for patients with obesity, but conforms to regulatory guidance and importantly, allows us to optimize dosing for the diabetic patients, where medically, I can say [inaudible], your considerable perspective, I'm unaware of a highly efficacious monthly or less frequently administered medicine for the treatment of diabetes. Murdo?

Robert A. Bradway: Can take this in two pieces again. Jay, why don't you address the first piece and then Murdo feel free to jump in.

Jay Bradner: Yes, absolutely. As you nicely identified later this year, we will initiate an additional dedicated Phase II study that will characterize MariTide from the treatment of diabetes in patients with and without obesity. And this new study is not a gating step at all for the Phase III program for patients with obesity, but conforms to regulatory guidance and importantly, allows us to optimize dosing for the diabetic patients, where medically, I can say [inaudible], your considerable perspective, I'm unaware of a highly efficacious monthly or less frequently administered medicine for the treatment of diabetes. Murdo? Yes. Thanks, Jay. I would agree with you that the differentiation that we've talked about for chronic weight management would hold in a robust way in type 2 diabetes. And while there are lots of products that can control hyperglycemia and provided HbA1c control, there is a significant benefit if you can improve adherence and persistence. And we do believe that our monthly dosing could do that.

Murdo Gordon: Yes. Thanks, Jay. I would agree with you that the differentiation that we've talked about for chronic weight management would hold in a robust way in type 2 diabetes. And while there are lots of products that can control hyperglycemia and provided HbA1c control, there is a significant benefit if you can improve adherence and persistence. And we do believe that our monthly dosing could do that. Next question, please, Julianne.

Unknown: Next question, please, Julianne.

Unknown: Next question, please, Julianne. Thank you, Chris. Our next question comes from Kripa Devarakonda from Truist Securities. Please go ahead. Your line is open.

Unknown: Next question, please, Julianne.

Operator: Thank you, Chris. Our next question comes from Kripa Devarakonda from Truist Securities. Please go ahead. Your line is open. Kripa

Operator: Thank you, Chris. Our next question comes from Kripa Devarakonda from Truist Securities. Please go ahead. Your line is open.

Srikripa Devarakonda: Hey, guys. Thank you so much for taking my question. Another obesity question but slightly tangential. I'm not sure if you've talked about this before but there's been a conversation about muscle preservation in people who are losing weight on glip. Have you evaluated this aspect with MariTide? Do you see this being the problem broadly in the space? If so, where do you think MariTide would fit into that landscape? Thank you.

Operator: Sure. Jay, why don't you jump in there? Sure. No, thank you.

Robert A. Bradway: Sure. Jay, why don't you jump in there?

Jay Bradner: Sure. No, thank you for your question. As you apparently do as well, are following this class and class of medicines that provoke remarkable weight loss or the impact on healthy tissues, including but not limited to muscle, and the associated muscle loss that has been reported in the literature may relate mechanistically and may also relate to the quite dramatic cadence of weight loss of patients treated with these medicines. And in the fullness of time, we and others will have that answer. As you can imagine, we're making many of these measurements on our own study and don't have any report--any data to report to you here today but we too are following this. And also the progress of some organizations that are seeking to administer medicine to support muscle loss with obesity medicines that is quite interesting to us given our legacy of muscle biology. But I would say these are early insights from the field. To my knowledge, they have not proven has yet to be debilitating to the patient but we like you follow with interest. Julianne

Unknown: Julianne saying we're getting to the top half of the hour here. Maybe we'll just take two more questions.

Operator: Our next question comes from James Shin from Deutsche Bank. Please go ahead. Your line is open.

James Shin: Hi, guys. Thanks for taking my question. For the next obesity asset that's entering clinics later this year, can you specify whether this asset is aimed to fill in for 786, and whether there's no next obesity asset will work in tandem with 133? Thank you.

Operator: Certainly. Thank you, Kripa. Our next question comes from James Shin from Deutsche Bank. Please go ahead. Your line is open. James

Operator: Certainly. Thank you, Kripa. Our next question comes from James Shin from Deutsche Bank. Please go ahead. Your line is open.

Jay Bradner: Thanks, James. We won't today provide any further insight into this medicine. It's just too early. And as Bob shared, this is nicely for patients, a very competitive space. But as I shared earlier, in our deeper pipeline in obesity, we remain interested in the increasing pathway. We remain interested injectable. We're also pursuing oral medicines. And so in the fullness of time, we'll have a chance to share more. We're really playing the long game to drive true differentiation benefits to the patient and to access segments of the market that are not well addressed even by the current medicines. Julianne, let's take our last question.

Unknown Executive: And as Bob shared, this is, nicely, for patients, a very competitive space. But as I shared earlier, in our deeper pipeline, in obesity, we remain interested in the incretin pathway. We've been interested in Jekyll. We're also pursuing oral medicines, and so in the fullness of time, we'll have a chance to share more. We're really playing the long game to drive a true differentiation benefit to the patient and to access segments of the market that are not well addressed even by the current medicines.

Unknown Executive: We're also pursuing oral medicines, and so in the fullness of time, we'll have a chance to share more. We're really playing the long game to drive a true differentiation benefit to the patient and to access segments of the market that are not well addressed even by the current medicines.

Unknown: Julianne, let's take our last question.

Operator: Thank you, James. Our last question will come from Gary Nachman from Raymond James. Please go ahead. Your line is open. So shifting to TEPEZZA. When do you think we'll see more of an acceleration in the low CAS patients? How has reimbursement been improving for those patients? And describe how much the Japanese opportunity could help next year? And then just talk about the overall resources you're putting behind TEPEZZA and the rest of the rare disease portfolio that obviously, a much bigger focus for you now, if that continues to ramp up at what pace and when you might get more operating leverage from that rare disease business?

Operator: Thank you, James. Our last question will come from Gary Nachman from Raymond James. Please go ahead. Your line is open.

Gary Nachman: So shifting to TEPEZZA. When do you think we'll see more of an acceleration in the low CAS patients? How has reimbursement been improving for those patients? And describe how much the Japanese opportunity could help next year? And then just talk about the overall resources you're putting behind TEPEZZA and the rest of the rare disease portfolio that obviously, a much bigger focus for you now, if that continues to ramp up at what pace and when you might get more operating leverage from that rare disease business? A lot of questions there, Gary, but why don't we take it in a couple of pieces. Go ahead, Vikram.

Robert A. Bradway: A lot of questions there, Gary, but why don't we take it in a couple of pieces. Go ahead, Vikram. Yes. So thanks for the question, Gary. Look, we're pretty pleased with how we've been executing on TEPEZZA this year and driving it towards growth. As you rightly observed, there are a significant number of low CAS patients or low clinical activity score patients that are suffering from this disease who are not being appropriately treated. And specifically, that's about 80,000 out of the 100,000 addressable patients in the U.S. What we have been doing is seeing significant momentum on expanding our prescriber base, which now in addition to oculoplastic surgeons also includes ophthalmologists and endocrinologists. And this is a really important element here. The strategic focus in endocrinology is really important so that we can serve those low C-A-S patients, the low CAS patients favorably. You asked about improving access. To date, we have achieved favorable medical policy changes for greater than 65% of U.S. covered lives. And if you compare that to 50% last quarter and just over 5% about a year ago, I think we've made pretty good progress in enabling patient access using our Phase IV data that have become available last year. So we continue to see a significant growth opportunity for TEPEZZA in the U.S. while also recognizing that as we make progress with a lot of our execution efforts, there continues to be a time lag between when we knock down barriers for access, expand our prescriber base and see patients get on therapy.

Robert A. Bradway: A lot of questions there, Gary, but why don't we take it in a couple of pieces. Go ahead, Vikram.

Vikram Karnani: Yes. So thanks for the question, Gary. Look, we're pretty pleased with how we've been executing on TEPEZZA this year and driving it towards growth. As you rightly observed, there are a significant number of low CAS patients or low clinical activity score patients that are suffering from this disease who are not being appropriately treated. And specifically, that's about 80,000 out of the 100,000 addressable patients in the U.S. What we have been doing is seeing significant momentum on expanding our prescriber base, which now in addition to oculoplastic surgeons also includes ophthalmologists and endocrinologists. And this is a really important element here. The strategic focus in endocrinology is really important so that we can serve those low C-A-S patients, the low CAS patients favorably. You asked about improving access. To date, we have achieved favorable medical policy changes for greater than 65% of U.S. covered lives. And if you compare that to 50% last quarter and just over 5% about a year ago, I think we've made pretty good progress in enabling patient access using our Phase IV data that have become available last year. So we continue to see a significant growth opportunity for TEPEZZA in the U.S. while also recognizing that as we make progress with a lot of our execution efforts, there continues to be a time lag between when we knock down barriers for access, expand our prescriber base and see patients get on therapy.

Vikram Karnani: So we continue to see a significant growth opportunity for TEPEZZA in the U.S. while also recognizing that as we make progress with a lot of our execution efforts, there continues to be a time lag between when we knock down barriers for access, expand our prescriber base and see patients get on therapy. In Japan, Gary, we expect that they'll be, again, an attractive market and this will be well received in that country, and we'll talk about that once we've launched there during the course of next year. With respect to leverage, I think I would just offer that we're on track. With respect to our synergy targets there, and we'll begin to get even more leverage as we're able to take full control of the supply chain for the rare disease products. And then I would just further observe, as we've said many times, that feel fortunate that there's a good overlap between some of our existing capabilities in sales and marketing and the needs of those rare disease products. So all in all, we remain really excited about what we're able to do for rare disease patients, the position we have and the likelihood of that just improving over time. So with that, let me thank all of you. I know we've gone a few minutes over the set time but thank you all for participating in the call, and we look forward to regrouping with you after the third quarter. Thanks.

Robert A. Bradway: In Japan, Gary, we expect that they'll be, again, an attractive market and this will be well received in that country, and we'll talk about that once we've launched there during the course of next year. With respect to leverage, I think I would just offer that we're on track. With respect to our synergy targets there, and we'll begin to get even more leverage as we're able to take full control of the supply chain for the rare disease products. And then I would just further observe, as we've said many times, that feel fortunate that there's a good overlap between some of our existing capabilities in sales and marketing and the needs of those rare disease products. So all in all, we remain really excited about what we're able to do for rare disease patients, the position we have and the likelihood of that just improving over time. So with that, let me thank all of you. I know we've gone a few minutes over the set time but thank you all for participating in the call, and we look forward to regrouping with you after the third quarter. Thanks. This concludes our 2024 Q2 earnings call. You may now disconnect.

Operator: This concludes our 2024 Q2 earnings call. You may now disconnect.

To accompany this call. We will also make some forward looking statements, which are qualified by our safe Harbor statement and please note that actual results can vary materially.

Bob: Over to you Bob.

Bob: Okay, well, thank you Justin and let me. Thank all of you for joining the call today, we're especially grateful.

Bob: In light of all the volatility.

Bob: In the markets that you would carve out the time to be with US. So thank you through the first half of the year, our business is performing well and we remain confident in our ability to deliver attractive long term growth. We are achieving strong results. The same way, we always have which is by providing innovative medicines to address challenging diseases.

Speaker Change: Starting with the end market portfolio second quarter revenues grew 20% to $8 $4 billion with numerous medicines delivering double digit sales growth, including in general Medicine, <unk>, an entity in oncology of course balloon <unk> and inflammation test spire, and then turning to <unk>.

Bob: Your disease, which delivered more than $1 billion on the quarter I would highlight the KRYSTEXXA and <unk> each delivered.

Speaker Change: At least double digit sales growth in the quarter and grew 8% year over year and 13% quarter over quarter. All of these first or best in class medicines are still early in their life cycles and have plenty of room to run through geographic expansion, new indications <unk> new formulations.

Speaker Change: You'll hear more about these brands in a moment.

Speaker Change: Turning to research and development, we believe our pipeline it looks very promising as well not just in obesity, but across all of our therapeutic areas.

Speaker Change: We told you at the beginning of the year that we were anticipating more than a dozen significant pipeline milestones in 2024.

Speaker Change: So far so good in the second quarter alone we received accelerated approval for <unk>.

Speaker Change: Landmark new medicine for small cell lung cancer.

Speaker Change: The physicians I've spoken to since approval I'm really excited about this drug is the first meaningful innovation in decades for these patients.

Speaker Change: We also received approval for <unk> in the frontline treatment for B cell precursor acute lymphoblastic leukemia based on significantly improved overall survival rates.

Speaker Change: The frontline approval meaningfully expands the potential impact of <unk> for all patients with B a L. L.

Speaker Change: We announced impressive phase III data for Prisma and IAG G. Four related disease, which is a grievous illness for which there are no currently approved therapies of any kind.

Bob Bradway: You'll hear more about these brands in a moment. Turning to research and development, we believe our pipeline looks very promising as well, not just in obesity but across all of our therapeutic areas. We told you at the beginning of the year that we were anticipating more than a dozen significant pipeline milestones in 2024. Well, so far, so good.

Speaker Change: Building on our success with test spire in treating severe asthma, we announced exciting data from our phase II study in patients with chronic obstructive pulmonary disease that earned this molecule.

Brands in a moment.

Speaker Change: Turning to research and development, we believe our pipeline it looks very promising as well not just <unk>.

Speaker Change: The city, but across all of our therapeutic areas.

Speaker Change: Through therapy designation.

Speaker Change: COPD is the worlds third leading cause of death and new treatment options are very much needed.

Speaker Change: We told you at the beginning of the year that we were anticipating more than a dozen significant pipeline milestones in 2024.

Speaker Change: We look forward to additional data Readouts later this year across therapeutic areas highlighted of course by topline data from the ongoing maritime phase two study.

Well so far so good in the second quarter alone we received accelerated approval for MD Altra, a landmark new medicine for small cell lung cancer.

Speaker Change: We're encouraged by the emerging data in this field, particularly in cardiovascular and renal disease areas of long standing strategic focus for us.

Speaker Change: <unk> physicians I've spoken to since approval are really excited about this drug is the first meaningful innovation in decades for these patients.

Speaker Change: We are laser focused on preparing to launch a broad phase III program for maritime that includes obesity obesity related conditions and type two diabetes and we are further ramping our investments to support maritime and the rest of the pipeline.

Speaker Change: We also received approval for <unk> in the frontline treatment for B cell precursor acute lymphoblastic leukemia based on significantly improved overall survival rates.

Speaker Change: The frontline approval meaningfully expands the potential impact of <unk> for all patients with B L.

Speaker Change: You'll hear more about that pipeline shortly on this call.

Speaker Change: All in all of this is a very exciting time for us at Amgen and then as always I'm grateful to my Amgen colleagues all around the world for their enduring commitment to patients.

Bob Bradway: We announced impressive Phase III data for Euplizma, an IgG4-related disease for which there are currently no currently approved therapies of any kind. Building on our success with Tespire in treating severe asthma, we announced exciting data from our Phase 2 study in patients with chronic obstructive pulmonary disease that earned this molecule breakthrough therapy designation. COPD is the world's third leading cause of death, and new treatment options are very much needed.

Speaker Change: We announced impressive phase III data for <unk>, and <unk> related disease, which is a grievous illness for which there are no currently approved therapies of any kind.

Speaker Change: Now, let me turn things over to Murdo.

Murdo: Thanks, Bob execution was strong in the second quarter, driving 20% year over year sales growth in all of our regions delivered attractive growth.

Murdo: <unk> of 12 products group at least double digits, including for Panther Aspire is entity tapioca and web sites. So all brands that are important to our future growth.

Speaker Change: Through therapy designation.

Speaker Change: COPD is the worlds third leading cause of death and new treatment options are very much needed.

Murdo: Starting with our general medicine portfolio sales of passive entity and Prolia collectively grew 20% year over year in the second quarter driven by volume growth.

Bob Bradway: We look forward to additional data readouts later this year across therapeutic areas, highlighted, of course, by top-line data from the ongoing Meritide Phase II study. We're encouraged by the emerging data in this field, particularly in cardiovascular and renal disease, areas of longstanding strategic focus for us. We are laser-focused on preparing to launch a broad Phase III program for Maritide that includes obesity, obesity-related conditions, and type 2 diabetes, and we're further ramping up our investment to support Maritide and the rest of the pipeline.

Speaker Change: We look forward to additional data Readouts later this year across therapeutic areas highlighted of course by topline data from the ongoing maritime phase II study.

Murdo: <unk> sales increased 25% year over year to $532 million for the second quarter now well on its way to becoming a multibillion dollar business in.

Speaker Change: We're encouraged by the emerging data in this field, particularly in cardiovascular and renal disease areas of long standing strategic focus for us.

Murdo: In the quarter, we saw year over year volume growth of 46%, partially offset by lower net selling price.

Murdo: In the U S. We see increased recognition of the importance of lowering LDL cholesterol by health care providers payers and patients, which has significantly accelerated volume growth for Papa.

Speaker Change: You'll hear more about that pipeline shortly on this call.

Speaker Change: Our efforts have broadened insurance coverage and removed prior authorization requirements by several pairs in a recent survey roughly 95% of cardiologists responded that repair is accessible and that access has improved significantly versus two years ago.

Speaker Change: All in all this is a very exciting time for us at Amgen and as always I'm grateful to my Amgen colleagues all around the world for their enduring commitment to patients.

Speaker Change: And now let me turn things over to Murdo.

Murdo Gordon: Thanks, Bob. Execution was strong in the second quarter, driving 20% year-over-year sales growth, and all of our regions delivered attractive growth. Sales of 12 products grew at least double digits, including Repatha, Tyspire, Ivenity, Tavneos, and Blinsito, all brands that are important to our future growth. Starting with our general medicine portfolio, sales of Repatha, Avenity, and Prolia collectively grew 20% year-over-year in the second quarter, driven by volume growth. Repata Sales increased 25% year-over-year to $532 million for the second quarter, and it is now well on its way to becoming a multi-billion-dollar business.

Murdo: Thanks, Bob execution was strong in the second quarter, driving 20% year over year sales growth.

Speaker Change: NSE sales increased 13, 9% year over year to $391 million for the second quarter.

Murdo: All of our regions delivered attractive growth.

Speaker Change: In the U S volume growth was supported by both increased prescription volume from existing a benetti prescribers and an expansion of new prescribers.

Murdo: Sales of 12 products grew at least double digits, including for Panther aspire, if entity Taphouse Amblin cycle, all brands that are important to our future growth.

Speaker Change: In Japan of entity has been prescribed to approximately 600000 patients to date and continues to be the segment leader with 45% of the bone builder segment.

Speaker Change: Starting with our general medicine portfolio sales of repair entity and Prolia collectively grew 20% year over year in the second quarter driven by volume growth.

Speaker Change: There are many women who remain at risk of a fracture due to post menopausal osteoporosis. We're encouraged by the growth momentum, we are driving and have conviction in the potential for them to help even more patients.

Speaker Change: <unk> sales increased 25% year over year to $532 million for the second quarter now well on its way to becoming a multibillion dollar business.

Murdo Gordon: In the quarter, we saw year-over-year volume growth of 46 percent, partially offset by lower net selling price. In the U.S., we see increased recognition of the importance of lowering LDL cholesterol by health care providers, payers, and patients, which has significantly accelerated volume growth for hepatitis. Our efforts have broadened insurance coverage and removed prior authorization requirements by several payers.

Speaker Change: Prolia sales increased 13% year over year to $1 $2 billion for the second quarter volume growth continues to be supported by real world evidence demonstrating <unk> superiority in reducing fracture risk when compared to alendronate in treatment nave patients with postmenopausal osteoporosis at high risk.

Speaker Change: In the quarter, we saw year over year volume growth of 46%, partially offset by lower net selling price in.

Speaker Change: In the U S. We see increased recognition of the importance of lowering LDL cholesterol by health care providers payers and patients, which has significantly accelerated volume growth for Papa.

Speaker Change: Our efforts have broadened insurance coverage and removed prior authorization requirements by several payers and a recent survey roughly 95% of cardiologists responded that path is accessible and that access has improved significantly versus two years ago.

Speaker Change: Fracture.

Speaker Change: In inflammation test fire continues its strong trajectory with $234 million in sales in the second quarter.

Murdo Gordon: In a recent survey, roughly 95% of cardiologists responded that Repatha is accessible and that access has improved significantly versus two years ago. Venity sales increased 39% year-over-year to $391 million for the second quarter. In the U.S., volume growth was supported by both increased prescription volume from existing Avenity prescribers and an expansion of new prescribers. In Japan, Avenity has been prescribed to approximately 600,000 patients to date and continues to be the segment leader with 45% of the bone builder segment. There are many women who remain at risk of a fracture due to postmenopausal osteoporosis.

Speaker Change: Sales increased 76% year over year, primarily driven by uptake of the pre filled single use pen we.

Speaker Change: <unk> sales increased 13, 9% year over year to $391 million for the second quarter.

Speaker Change: We see strong growth opportunity for test buyer given its unique differentiated profile and has broad potential to treat the $2 5 million patients worldwide with severe uncontrolled asthma.

Speaker Change: In the U S volume growth was supported by both increased prescription volume from existing a benetti prescribers and an expansion of new prescribers in Japan of entity has been prescribed to approximately 600000 patients to date and continues to be the segment leader with 45% of the bone builder segment.

Speaker Change: With tangible sales decreased 9% year over year for the second quarter with 2% volume growth offset by lower net selling price and unfavorable changes to estimated sales deductions.

Speaker Change: In the U S. We thought we saw 3% year over year growth in new patient prescriptions in the quarter driven by strong execution by our dermatology sales force and increased <unk> direct to consumer media activity.

Speaker Change: We've seen an increasingly competitive environment in dermatology with the introduction of novel topical is a new biologic treatments.

Speaker Change: <unk> sales increased 13% year over year to $1 $2 billion for the second quarter volume growth continues to be supported by real world evidence demonstrating <unk> superiority in reducing fracture risk when compared to alendronate in treatment nave patients with postmenopausal osteoporosis at high risk of fracture.

Speaker Change: <unk> retains an important role in this landscape given his broad label safety profile and unique positioning as the first systemic treatment option for patients with psoriasis.

Speaker Change: Enbrel sales decreased 15% year over year for the second quarter, primarily driven by lower net selling price going forward. We expect continued declining net selling price and relatively flat volumes and <unk> is known for its efficacy and trusted by physicians.

Speaker Change: Sure.

Murdo Gordon: In inflammation, test fire continues its strong trajectory with $234 million in sales in the second quarter. Sales increased 76% year-over-year, primarily driven by uptake of the pre-filled, single-use. We see strong growth opportunities for Tespire given its unique differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma. OTSLA sales decreased 9% year-over-year for the second quarter, with 2% volume growth offset by lower net selling prices and unfavorable changes to estimated sales deductions.

Speaker Change: In inflammation test buyer continues its strong trajectory with $234 million in sales in the second quarter.

Speaker Change: Sales increased 76% year over year, primarily driven by uptake of the pre filled single use pen we.

Speaker Change: Substantial health benefits and cash flow generation provide a solid foundation for our business.

Speaker Change: Turning now to Biosimilars, where sales of our Biosimilar products were relatively stable year over year for the second quarter, we're positioned for future growth with upcoming launches with Lana Biosimilar to Soliris and <unk> a biosimilar to Soliris are both expected to launch in the U S. In Q1 of 2025.

Speaker Change: <unk> sales decreased 9% year over year for the second quarter with 2% volume growth offset by lower net selling price and unfavorable changes to estimated sales deductions.

Speaker Change: Particularly integrated Biosimilar business model ensures efficiency and provides attractive cash flows and returns for our shareholders.

Murdo Gordon: In the U.S., we saw 3% year-over-year growth in new patient prescriptions in the quarter, driven by strong execution by our dermatology sales force and increased Otesla direct-to-consumer media activity. We've seen an increasingly competitive environment in dermatology with the introduction of novel topicals and new biologic treatments. Otezla retains an important role in this landscape given its broad label, safety profile, and unique positioning as a first systemic treatment option for patients with psoriasis. MBREL sales decreased 15% year-over-year for the second quarter, primarily driven by a lower net selling price. Going forward, we expect continued decline in net selling price and relatively flat volumes.

Speaker Change: And oncology sales of our seven innovative products Bulletin cycle, <unk>, Vectibix, Kyprolis and ex Java, and Delta grew 12% year over year for the second quarter, driven by volume growth and higher net selling price.

Speaker Change: We've seen an increasingly competitive environment in dermatology with the introduction of novel topical is a new biologic treatments.

Speaker Change: <unk> retains an important role in this landscape given his broad label safety profile and unique positioning as the first systemic treatment option for patients with psoriasis.

Speaker Change: In total these products contributed almost $2 billion of sales in the second quarter.

Speaker Change: <unk> sales grew 28% year over year to $264 million for the second quarter, driven by broad prescribing across academic and community segments for patients with B cell a L. L.

Speaker Change: <unk> was recently granted approval by the U S food and drug administration as a frontline consolidation treatment for patients with Philadelphia chromosome negative b cell a L. L. A commercial and medical teams are engaging key academic regional and community customers.

Murdo Gordon: Ambrose is known for its efficacy and trusted by physicians. Its substantial health benefits and cash flow generation provide a solid foundation for our business. Turning now to biosimilars, where sales of our biosimilar products were relatively stable year over year for the second quarter. We're positioned for future growth with upcoming launches, with Lana, a biosimilar to Stellara, and Bikambi, a biosimilar to Solaris, both expected to launch in the US in Q1 of 2025. They are vertically integrated by a similar business model that ensures efficiency and provides attractive cash flows and returns

Speaker Change: <unk> is known for its efficacy and trusted by physicians.

Speaker Change: Substantial health benefits and cash flow generation provide a solid foundation for our business.

Speaker Change: Turning now to Biosimilars, where sales of our Biosimilar products were relatively stable year over year for the second quarter, we're positioned for future growth with upcoming launches with Lana Biosimilar to spill Ara and <unk> a biosimilar to Soliris are both expected to launch in the U S. In Q1 of 2025.

Speaker Change: Establishing <unk> as standard of care in this setting.

Speaker Change: <unk> sales increased 10% year over year to $85 million for the second quarter, we see future growth opportunities for <unk> coming from launches in new markets and additional indications.

Speaker Change: Particularly integrated Biosimilar business model ensures efficiency and provides attractive cash flows and returns for our shareholders.

Speaker Change: <unk> sales increased 9% year over year to $270 million for the second quarter now annualizing at over $1 billion.

Murdo Gordon: In Oncology, sales of our seven innovative products, Lincyto, Lumicraz, Vectabix, Kyprolis, Endplate, Xgeva, and Nymdeltra, grew 12% year-over-year for the second quarter, driven by volume growth and higher net selling price. In total, these products contributed almost $2 billion in sales in the second quarter.

Speaker Change: In oncology sales of our seven innovative products <unk>, Vectibix, Kyprolis and ex Java, and Delta grew 12% year over year for the second quarter, driven by volume growth and higher net selling price.

Speaker Change: We also drove strong performance of Kyprolis, which grew 9% year over year.

Speaker Change: <unk>, which grew 12% year over year.

Speaker Change: Since our U S launch of <unk> Delta in mid May we generated $12 million of sales in the second quarter and Delta was recently approved for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum based chemotherapy.

Speaker Change: In total these products contributed almost $2 billion of sales in the second quarter.

Murdo Gordon: CytoSills grew 28% year-over-year to $264 million for the second quarter, driven by broad prescribing across academic and community segments for patients with B-cell ALL. Blincito was recently granted approval by the U.S. Food and Drug Administration as a frontline consolidation treatment for patients with Philadelphia Chromosome Negative B-Cell ALL. Our commercial and medical teams are engaging key academic, regional, and community customers in establishing Blincito as a standard of care in this setting.

Speaker Change: <unk> sales grew 28% year over year to $264 million for the second quarter, driven by broad prescribing across academic and community segments for patients with B cell ALLL.

Speaker Change: We're seeing strong clinical conviction in delta in both academic and community settings.

Speaker Change: We're very early in the launch we are encouraged by the adoption of <unk> Delta and look forward to its potential to bring new possibilities to patients living with this aggressive disease.

Speaker Change: <unk> was recently granted approval by the U S food and drug administration as a frontline consolidation treatment for patients with Philadelphia chromosome negative b cell all.

Speaker Change: I am pleased with our execution in the quarter driving accelerated performance for our most important growth brands and with that I'll turn it over to Vikram, who will cover our rare disease portfolio.

Speaker Change: Our commercial and medical teams are engaging key academic regional and community customers.

Speaker Change: Establishing <unk> as standard of care in this setting.

Murdo Gordon: Lumicrass sales increased 10% year-over-year to $85 million for the second quarter. We see future growth opportunities for Lumicrass coming from launches in new markets and additional indications. Vectivix sales increased 9% year-over-year to $270 million for the second quarter, now annualizing at over a billion dollars. We also drove strong performance for Kyprolis, which grew 9% year-over-year, and Endplate, which grew 12% year-over-year. Since our U.S. launch of IMDELTA in mid-May, we generated $12 million in sales in the second quarter.

Vikram: Thank you Mariano.

Vikram: I am pleased to provide an update on rare disease, which delivered product sales of over $1 1 billion in Q2.

Vikram: Beginning with <unk> for the treatment of thyroid eye disease second quarter sales were $479 million.

Speaker Change: <unk> sales increased 9% year over year to $270 million for the second quarter net annualized and over a $1 billion.

Vikram: Reflecting growth of 8% year over year, and 13% quarter over quarter when compared to the results from the legacy horizon business.

Speaker Change: We also drove strong performance of Kyprolis, which grew 9% year over year and plate, which grew 12% year over year.

Vikram: Recall that there are roughly 100000 <unk> patients in the U S and penetration is currently only in the single digits.

Vikram: The main growth opportunity is within the roughly 80% of <unk> patients, who have a low clinical activity score or Cas.

Murdo Gordon: IMDELTA was recently approved for the treatment of adult patients with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. We're seeing strong clinical conviction for MDELTA in both academic and community settings. While this is a very early stage in the launch, we're encouraged by the adoption of MDELTA and look forward to its potential to bring new possibilities to patients living with this aggressive disease. I'm pleased with our execution in the quarter, driving accelerated performance for our most important growth brands. And with that, I'll turn it over to Vikram, who'll cover our rare disease portfolio.

Speaker Change: We're expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists, who manage many of the low caste patients who can benefit from peso.

Speaker Change: We're seeing strong clinical conviction in Belgium, both academic and community settings, and while very early in the launch we are encouraged by the adoption of <unk> Delta and look forward to its potential to bring new possibilities to patients living with this aggressive disease.

Speaker Change: The impact of pattern I receive on quality of life is often underestimated. So our focus is on educating healthcare providers about the significant effects on patients even those with less visible symptoms in.

Speaker Change: In addition, we are increasing our strategic focus in endocrinology with a dedicated sales force to engage in this important space.

Vikram Karnani: Thank you, Murdo. I am pleased to provide an update on Rare Disease, which delivered product sales of over $1.1 billion in Q2. Beginning with Tepeza for the treatment of thyroid eye disease, second quarter sales were $479 million, reflecting growth of 8% year-over-year and 13% quarter-over-quarter when compared to results from the Legacy Horizon business. Recall that there are roughly 100,000 TED patients in the U.S., and penetration is currently only in the single digits.

Vikram: Thank you Murdo.

Vikram: I am pleased to provide an update on rare disease, which delivered product sales of over $1 1 billion in Q2.

Speaker Change: We're also making significant strides in improving access thanks to the recognition of the pet of efficacy by payers to date, we have achieved favorable medical policy changes, both greater than 55% of U S covered lives compared to 50% last quarter, and just 5% roughly one year.

Vikram: Beginning with <unk> for the treatment of thyroid eye disease.

Speaker Change: Second quarter sales were $479 million.

Speaker Change: Reflecting growth of 8% year over year, and 13% quarter over quarter when compared to the results from the legacy horizon business.

Speaker Change: Ago.

Speaker Change: We expect to continue this momentum throughout 2024.

Speaker Change: Recall that there are roughly 100000 <unk> patients in the U S and penetration is currently only in the single digits. The.

Speaker Change: International expansion remains a meaningful long term growth opportunity for <unk> with regulatory filings complete or underway in multiple geographies with Japan as the next significant launch expected by early 2025.

Vikram Karnani: The main growth opportunity is within the roughly 80% of TED patients who have a low clinical activity score or CAS. We are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists, who manage many of the low-cast patients who can benefit from TIFETS. The impact of sighted eye disease on quality of life is often underestimated, so our focus is on educating healthcare providers about the significant effects on patients, even those with less visible symptoms.

Speaker Change: The main growth opportunity is within the roughly 80% of <unk> patients, who have a low clinical activity score or Cas.

Speaker Change: We also initiated a phase III subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation.

Speaker Change: We are expanding our reach among new prescribers, particularly ophthalmologists and endocrinologists, who manage many of the low caste patients who can benefit from peso.

Speaker Change: The impact of pattern either fees on quality of life is often underestimated. So our focus is on educating healthcare providers about the significant effects on patients even those with less visible symptoms.

Speaker Change: KRYSTEXXA for patients with chronic refractory gout delivered $294 million in sales in Q2, representing 20% year over year growth driven by volume growth from strong commercial execution.

Speaker Change: In addition, we are increasing our strategic focus and endocrinology with a dedicated sales force to engage in this important space.

Speaker Change: <unk> with immuno modulation continues to redefine the standard of care for uncontrolled gout.

Speaker Change: We are also making significant strides in improving access thanks to the recognition of depends of efficacy by payers.

Speaker Change: Ah.

Speaker Change: Listener for patients with Neuromodulators optica spectrum disorder or <unk> delivered.

Speaker Change: Date, we have achieved favorable medical policy changes for greater than 55% of U S covered lives compared to 50% last quarter, and just 5% roughly one year ago.

Speaker Change: We delivered $92 million in sales in Q2, representing 35% year over year over year growth.

Speaker Change: International expansion of our plasma is also underway with launches in multiple ex U S markets, including Canada, which launched earlier this year.

Speaker Change: We expect to continue this momentum throughout 2024.

Speaker Change: International expansion remains a meaningful long term growth opportunity for <unk> with regulatory filings complete or underway in multiple geographies.

Speaker Change: In addition to <unk>, we are excited about the impressive phase III results with <unk> in <unk> related disease, and the potential it has to address a debilitating condition that impacts more than 20000 patients in the U S.

Pam: Pam as the next significant launch expected by early 2025.

Pam: We also initiated a phase III subcutaneous study and see this as an opportunity to increase adoption and improve the patient experience with an alternative option to our current IV formulation.

Speaker Change: We also look forward to the phase III readout for <unk> in myasthenia Gravis later this year.

Speaker Change: Dave will address these in more detail in a moment.

Speaker Change: Sales of tab news were $71 million.

Speaker Change: For the second quarter.

Dave: Sales increased 137% year over year, driven by volume growth.

Dave: In the U S more than 3500 patients with <unk> associated vasculitis have been treated with tab news.

Speaker Change: KRYSTEXXA with immuno modulation continues to redefine the standard of care for uncontrolled gout.

Speaker Change: Over 2300 health care professionals have now prescribed <unk>.

Speaker Change: Uplift now for patients with Neuromodulators optica spectrum disorder or <unk>.

Speaker Change: Roughly 35% increase in the prescriber base. So far this year the integration of the legacy Horizon business is progressing nicely as we leverage Amgen leadership inflammation.

Speaker Change: Delivered $92 million in sales in Q2, representing 35% year over year over year growth.

Vikram Karnani: International expansion of APLISNA is also underway, with launches in multiple ex-US markets, including Canada, which launched earlier this year. In addition to NMOSD, we are excited about the impressive Phase 3 results with Oplizna in IgG4-related diseases and the potential it has to address a debilitating condition that impacts more than 20,000 patients in the U.S. We also look forward to the Phase 3 readout for PLSNA in Jay will address these in more detail in a moment.

Speaker Change: World Class manufacturing and process development and extensive global footprint.

Speaker Change: International expansion is also underway with launches in multiple ex U S markets, including Canada, which launched earlier this year.

Speaker Change: Now I will pass it over to Jay for our R&D update.

Jay: Thank you Vikram and good afternoon, everyone in the second quarter, we rapidly advanced our broad clinical pipeline of potentially first in class or best in class programs.

Speaker Change: In addition to <unk>, we are excited about the impressive phase III results with the <unk> in <unk> related disease and the potential it has to address a debilitating condition that impacts more than 20000 patients in the U S.

Jay: We received two approvals in the quarter, a breakthrough therapy designation and delivered exciting clinical data for many programs while eagerly awaiting additional data Readouts later this year.

Speaker Change: We also look forward to the phase III readout for <unk> in myasthenia Gravis later this year.

Speaker Change: Let's begin with general medicine.

Jay: As previously mentioned based on the interim analysis, we are seeing a differentiated profile with maritime and are confident it will address important unmet medical needs in obesity obesity related conditions and type two diabetes.

Speaker Change: Jay will address these in more detail in a moment.

Vikram Karnani: Sales of Tavneos were $71 million for the second quarter. Sales increased 137% year-over-year, driven by volume growth.

Jay: Sales of tab news were $71 million for the second quarter.

Jay: <unk> increased 137% year over year, driven by volume growth.

Speaker Change: We remain on track and look forward to top line 52 week data from the ongoing maritime Phase III study in late 2024, we are actively planning and expect to initiate a broad phase III program in obesity obesity related conditions in diabetes, along with our phase II trial investigating maritime for the treatment of diabetes.

Speaker Change: In the U S more than 3500 patients with <unk> associated vasculitis have been treated with tab news.

Jay: Over 2300 health care professionals have now prescribed tab news at roughly 35% increase in the prescriber base. So far this year the <unk>.

In patients with and without obesity.

Speaker Change: Integration of the legacy Horizon business is progressing nicely as we leverage Amgen leadership inflammation World class manufacturing and process development and extensive global footprint.

Speaker Change: Beyond Maritime we continue to progress our early obesity programs that consists of both oral and injectable incretin and non creating approaches we expect one of these programs to enter clinical development later this year.

Speaker Change: Also in Gen. Med is all pass ran our potentially best in class L. P. Little a targeting small interfering RNA medicine to.

Speaker Change: The fully enrolled phase III cardiovascular outcomes trial level pass rent continues to progress.

Bob Bradway: We received two approvals in the quarter, a breakthrough therapy designation, and delivered exciting clinical data for many programs, while eagerly awaiting additional data readouts later this year. As previously mentioned, based on the interim analysis, we are seeing a differentiated profile with Meritide and are confident it will address important unmet medical needs in obesity, obesity-related conditions, and type 2 diabetes. Beyond Maritide, we continue to progress our early obesity programs that consist of both oral and injectable, incretin and non-incretin approaches.

Speaker Change: To remind L. P. Little a is a genetically defined cardiovascular risk factor that is elevated and approximately 20% of individuals and for whom no effective or targeted therapies currently exist.

Speaker Change: In oncology, we continue to deliver on high conviction targets with differentiated therapies capable of delivering transformative clinical benefit for patients.

Speaker Change: Let's begin with <unk>, our first in class bi specific T cell engagements or bite molecule targeting DLL three for small cell lung cancer. We're very pleased that the FDA granted accelerated approval to a delta for the treatment of adult patients with extensive stage small cell lung cancer with disease progression.

Speaker Change: Or after platinum based chemotherapy.

Speaker Change: Further we are pleased that the NCC and guidelines have been updated to include <unk> as a preferred option for patients with a chemotherapy free interval of less than or equal to six months.

Speaker Change: Turning to progress our early obesity programs that consists of both oral and injectable incretin and non creating approaches we expect one of these programs to enter clinical development later this year.

Speaker Change: And as in other recommended treatment option for patients with a chemotherapy free interval greater than six months based on the remarkable activity observed as a single agent in patients receiving second and third line therapy. We are rapidly advancing in delta into frontline therapy with three phase III studies underway in both extensive and.

Bob Bradway: We expect one of these programs to enter clinical development later this year. The Fully Enrolled Phase III Cardiovascular Outcomes Trial of Opasaran continues to progress. To remind you, LP little a is a genetically defined cardiovascular risk factor that is elevated in approximately 20% of individuals and for whom no effective or targeted therapies currently exist.

Speaker Change: Also in Gen. Med is all pass around our potentially best in class LP Little a targeting small interfering RNA medicine.

Speaker Change: The fully enrolled phase III cardiovascular outcomes trial level pass rent continues to progress.

Speaker Change: <unk> stage disease.

Speaker Change: To remind LP little a is the genetically defined cardiovascular risk factor that is elevated and approximately 20% of individuals and for whom no effective or targeted therapies currently exists.

Speaker Change: One of these studies Delphi three or four our confirmatory phase III study in second line small cell lung cancer has completed enrollment.

Speaker Change: Notably in Delta is the first bi specific T cell engaged are approved to treat a common solid tumor.

Speaker Change: In oncology, we continue to deliver on high conviction targets with differentiated therapies capable of delivering transformative clinical benefit for patients.

Speaker Change: Present study of <unk> in earlier lines and in the context of lower tumor burden draws from our experience with our first approved by specific T cell engagements blend <unk> and b cell acute lymphoblastic leukemia.

Speaker Change: Let's begin with them Delta a first in class bi specific T cell engagements or bite molecule targeting DLL three for small cell lung cancer. We're very pleased that the FDA granted accelerated approval to a delta for the treatment of adult patients with extensive stage small cell lung cancer with disease progression.

Speaker Change: Here, we observed a dramatic improvement in overall survival and minimal residual disease negative patients along with improved tolerability.

Speaker Change: These blend silo data provide evidence that directing the T cell in this manner is an effective means of finding and eliminating residual cancer cells that are drivers of recurrence.

Speaker Change: On or after platinum based chemotherapy.

Speaker Change: Further we are pleased that the NCC guidelines have been updated to include <unk> as a preferred option for patients with a chemotherapy free interval of less than or equal to six months and as in other recommended treatment option for patients with a chemotherapy free interval greater than six months based on the remarkable activity.

Speaker Change: This June based on the profound survival benefit observed in the treatment of frontline disease. The FDA approved an additional indication for <unk> for the treatment of adult and pediatric patients one month or older with CD 19 positive Philadelphia chromosome negative b cell ALLL in the consolidation phase of treatment here.

Speaker Change: Or regardless of minimal residual disease status.

We continue to seek to expand the impact of <unk> in newly diagnosed <unk> through ongoing studies and with the further investigation of subcutaneous administration.

Speaker Change: Our first in class steep one CD three bi specific molecule <unk> has also demonstrated profound clinical activity in metastatic castrate resistant prostate cancer importantly, demonstrating our ability to target a second common solid tumor with a bispecific T cell engaging therapy.

Speaker Change: We are rapidly advancing this program and have now fully enrolled the monotherapy phase one dose expansion as we continue to enroll patients and reduced monitoring and outpatient cohorts.

Speaker Change: Further we are advancing the study of salary to make earlier in the prostate cancer treatment paradigm with combinations of <unk> and <unk> or abiraterone ongoing while we plan additional studies in earlier disease settings.

Speaker Change: In sum, we regard them Delta upland <unk> celebrated make as major advances further establishing the broad potential of our leading bi specific T cell engage your platform.

Speaker Change: To round out oncology, we have completed enrollment of Fortitude 100, what a phase III study of <unk>, a first in class fibroblast growth factor receptor <unk> directed monoclonal antibody administered in combination with chemotherapy in frontline gastric cancer.

Bob Bradway: We continue to seek to expand the impact of Blin CITO in newly diagnosed BALL through ongoing studies and with the further investigation of subcutaneous administration. We are also pleased to announce that the FDA recently granted Tespire a breakthrough therapy designation as an add-on maintenance treatment for patients with moderate to very severe COPD, characterized by the eosinophilic phenotype. Beyond COPD, we continue to explore test fire in separate Phase 3 studies in eosinophilic esophagitis and in chronic rhinosinusitis with nasal polyps, where top-line data are expected later this year.

Speaker Change: We are also rapidly advancing AMG 193, our oral <unk> inhibitor developed for EM tap no solid tumors as both a monotherapy and in combination with other therapies.

Speaker Change: Cancer.

Speaker Change: Additional data from the phase one dose escalation and initial dose expansion study of AMG 193 in patients with <unk> solid tumors will be presented at ESMO in September.

Speaker Change: Importantly, demonstrating our ability to target a second common solid tumor with a bi specific T cell engagements therapy.

Speaker Change: We are rapidly advancing this program and have now fully enrolled the monotherapy phase one dose expansion as we continue to enroll patients and reduce monitoring and outpatient cohorts.

Speaker Change: Lastly, we are pleased also to share that the FDA has granted an orphan drug designation to AMG 193 for the treatment of pancreatic cancer turning to inflammation. We are encouraged by the data arising from our phase II study of <unk> in patients with moderate to very severe COPD.

Speaker Change: Further we are advancing the study of <unk> earlier in the prostate cancer treatment paradigm with combinations of <unk> and <unk> or abiraterone ongoing while we plan additional studies in earlier disease settings.

Speaker Change: Gather with Astrazeneca, we are actively planning for phase III development in COPD.

Speaker Change: And some with regard to the Delta upland <unk> celebrated make as major advances further establishing the broad potential of our leading bi specific T cell engage your platform.

Speaker Change: We are also pleased to announce that the FDA recently granted Ted's fire a breakthrough therapy designation as an add on maintenance treatment of patients with moderate to very severe COPD characterized by the eosinophilic phenotype.

Speaker Change: To round out oncology, we've completed enrollment of Fortitude 100, what a phase III study of <unk>, a first in class fibroblast growth factor receptor <unk> directed monoclonal antibody administered in combination with chemotherapy in frontline gastric cancer.

Speaker Change: Beyond COPD, we continue to explore test fire in separate phase III studies in eosinophilic esophagitis, and chronic rhinosinusitis with nasal polyps, where top line data are expected later this year.

Speaker Change: We are also rapidly advancing AMG 193, our oral <unk> inhibitor developed for EM tap no solid tumors as both a monotherapy and in combination with other therapies.

Speaker Change: Turning to <unk>, our first in class T cell rebalancing monoclonal antibody targeting the ox 40 receptor.

Speaker Change: The comprehensive <unk> Mab phase III rocket program has successfully enrolled over 3100 patients with moderate to severe atopic dermatitis.

Speaker Change: Five of the eight studies are now fully enrolled.

Speaker Change: The phase III Horizon study part of this rocket program evaluates <unk> monotherapy versus placebo in adults with moderate to severe atopic dermatitis and it is ongoing with data readout anticipated in each two.

Speaker Change: Beyond atopic dermatitis, we continue to explore the potential of <unk> in additional indications and have initiated a phase II study in moderate to severe asthma as well as a phase III study in perrigo nausea layers.

Speaker Change: Shifting to rare disease, we are encouraged by the advancements of our rare disease pipeline with several mid to late stage opportunities.

Speaker Change: A pleasant a CD 19, b cell depleting therapy offers a differentiated mechanism of action and other autoimmune therapies durable efficacy with a convenient every six months IV dosing schedule it could be very important for chronic inflammatory diseases.

Speaker Change: Recently, we were excited to announce positive topline results from our phase III clinical trial evaluating the efficacy and safety of a pleasant for the treatment of immunoglobulin G four related disease.

Bob Bradway: Turning to rocatinlamab, a first-in-class, T-cell-rebalancing monoclonal antibody targeting the OX40 receptor, the comprehensive rocatinlamab Phase III rocket program has successfully enrolled over 3,100 patients with moderate to severe atopic dermatitis. Five of the eight studies are now fully enrolled.

Speaker Change: The trial met its primary endpoint showing an astonishing 87% reduction in the risk of ITG for related disease flare has compared to placebo during the 52 week placebo controlled window.

Bob Bradway: This Phase III Horizon Study, part of this ROCKIT program, evaluates rocatinlamab monotherapy versus placebo in adults with moderate to severe atopic dermatitis, and it is ongoing with data readout anticipated in H2. Beyond atopic dermatitis, we continue to explore the potential of rocatinlamab and additional indications and have initiated a Phase 2 study in moderate to severe asthma, as well as Aplizna, a CD19 B-cell depleting therapy, offers a differentiated mechanism of action than other autoimmune therapies, and durable efficacy with a convenient every six month IV dosing schedule. This could be very important for chronic inflammatory diseases.

Speaker Change: All key secondary endpoints were also met and no new safety signals were identified.

Regulus: This is the first randomized controlled trial to demonstrate efficacy in the ITG for related disease patient population Regulus.

Regulus: Regulatory filing activities are underway and full data from the trial will be presented at a future medical meeting.

Regulus: We are also studying <unk> in generalized myasthenia gravis through the ongoing phase III <unk> study.

Speaker Change: Additional indications and have initiated a phase II study in moderate to severe asthma as well as a phase III study and perrigo nausea layers.

The study is evaluating the efficacy and safety of <unk> in patients with generalized myasthenia gravis, who are of a comparable disease severity and a comparable treatment experience to other recently approved biologic therapies.

Speaker Change: Shifting to rare disease, we are encouraged by the advancements of our rare disease pipeline with several mid to late stage opportunities.

Speaker Change: <unk>, a CD 19, B cell depleting therapy offers a differentiated mechanism of action than other autoimmune therapies durable efficacy with a convenient every six months IV dosing schedule. This could be very important for chronic inflammatory diseases.

Regulus: We are investigating a pleasant and the two predominant antibody serotypes that drive this disease of Cedar choline receptor positive and in muscle specific tyrosine kinase positive patients mint is the only trial attempting to demonstrate efficacy while removing the treatment benefit of steroids patients in the mint trial, who entered on steroids had a.

Bob Bradway: Recently, we were excited to announce positive top-line results from a Phase III clinical trial evaluating the efficacy and safety of eplizuna for the treatment of immunoglobulin G4-related disease. The trial met its primary endpoint, showing an astonishing 87% reduction in the risk of IgG4-related disease flare as compared to placebo during the 52-week placebo-controlled window. This is the first randomized control trial to demonstrate efficacy in the IgG4-related disease patient population. Regulatory filing activities are underway, and full data from the trial will be presented at a future medical meeting.

Speaker Change: Protocol specified paper by 24 weeks, we look forward to data readout second half of 2024 to expand the impact of our CD 19, directed therapeutics to even more patients suffering from serious inflammatory diseases compelled by both biological and for instance, and insights from small studies of CD 19 directed therapies.

Speaker Change: All key secondary endpoints were also met and no new safety signals were identified.

Speaker Change: We are launching a development program targeting CD 19 positive b cell mediated autoimmune disease with a pleasant and putting in tumor mab.

Speaker Change: This is the first randomized controlled trial to demonstrate efficacy in the ITG for related disease patient population regulatory filing activities are underway and full data from the trial will be presented at a future medical meeting.

Speaker Change: This is an exciting and promising space with Amgen strong capabilities in inflammatory disease and to well characterized assets, we are very well positioned to lead in this rapidly advancing field.

Speaker Change: We are also studying <unk> in generalized myasthenia gravis through the ongoing phase III <unk> study.

Speaker Change: We will have more to say about these programs in due course.

Speaker Change: Lastly in May the FDA approved <unk> as the first interchangeable biosimilar to soliris or equalize them at.

Speaker Change: Also in Biosimilar development registration, enabling studies are underway for ABP $2 34, a biosimilar candidate to Keytruda and ABP 206, a biosimilar candidate to Opdivo and.

Bob Bradway: We are investigating aplisna in the two predominant antibody stereotypes that drive this disease, acetylcholine receptor positive and, in muscle-specific, tyrosine kinase positive patients. MINT is the only trial attempting to demonstrate efficacy while removing the treatment benefit of steroids. Patients in the MINT trial who entered on steroids had a protocol-specified taper by 24 weeks. We look forward to data readout in the second half of 2024. To expand the impact of our CD19-directed therapeutics to even more patients suffering from serious inflammatory diseases, compelled by both biological inferences and insights from small studies of CD19-directed therapies, we are launching a development program targeting CD19-positive B-cell-mediated autoimmune disease with aplisna and blinetumamab. We will have more to say about these programs in due course. Also in biosimilar development, registration-enabling studies are underway for ABP234, a biosimilar candidate to Keytruda, and ABP206, a biosimilar candidate to Opdivo.

Speaker Change: In closing I'd like to thank my Amgen colleagues for their strong sense of service to patients facing serious illness their intense focus and spirited collaboration during this momentous year and their commitment to growing the impact of both our research and our business.

Speaker Change: This portfolio of potential first in class and best in class medicines.

Speaker Change: I'll now turn it over to Peter.

Peter: Thank you Jay we're pleased with our strong second quarter performance and are on track with our 2020 for full year goals and objectives. We have a strong long term growth outlook across all therapeutic areas driven by the breadth and depth of our innovative pipeline and end market products serving patients with <unk>.

Peter: Serious illnesses around the globe.

Speaker Change: Starting with our second quarter results as shown on slide 27 of the slide deck, we delivered $8 4 billion and total revenue at 20% increase year over year, it's the highest quarterly revenues Nam and Amgen history achieved with 26% volume growth. This means more patients than ever are receiving <unk>.

Peter: <unk> medicines.

Peter: Excluding the addition of horizon product sales increased 5% year over year, driven by 10% volume growth.

Peter: In the second quarter, we delivered a non-GAAP operating margin of 48, 2% as a percentage of product sales with total non-GAAP operating expenses, increasing 30% year over year.

Peter: non-GAAP cost of sales as a percent of product sales increased <unk> four percentage points on a year over year basis, primarily driven by higher royalties and profit share due to changes in sales mix.

Peter: non-GAAP R&D spending in the second quarter increased 30% year over year as we strategically invested in the late stage pipeline, including Maritime Rocha <unk>, the math as well as horizon acquired program <unk>.

Peter: non-GAAP SG&A expenses increased 36% year over year, primarily driven by the addition of horizon. Excluding the addition of horizon non-GAAP SG&A expenses increased 14% year over year driven by investments in <unk>.

Speaker Change: Weighted pipeline and end market products, serving patients with serious illnesses around the globe.

Bob Bradway: Starting with our second quarter results, as shown on slide 27 of the slide deck, we delivered $8.4 billion in total revenue, a 20% increase year-over-year. It's the highest quarterly revenue in Amgen history, achieved with 26% volume growth. This means more patients than ever are receiving Amgen medicine.

Speaker Change: Starting with our second quarter results as shown on slide 27 of the slide deck, we delivered $8 $4 billion in total revenue a 20% increase year over year, it's the highest quarterly revenues Nam and Amgen history achieved with 26% volume growth.

Speaker Change: Tesla and of entity.

Speaker Change: Our non-GAAP Oi any resulted in a $700 million expense up $400 million year over year almost entirely due to increased interest expenses from the horizon acquisition, we remain on track to deleverage with line of sight to retry retiring greater than $10 billion of debt by the.

Speaker Change: This means more patients than ever are receiving Amgen medicines. Excluding the addition of horizon product sales increased 5% year over year, driven by 10% volume growth.

Bob Bradway: Excluding the addition of Horizon, product sales increased 5% year-over-year driven by 10% volume growth. In the second quarter, we delivered a non-GAAP operating margin of 48.2% as a percentage of product sales, with total non-GAAP operating expenses increasing 30% year over year. Non-GAAP cost of sales as a percent of product sales increased 0.4 percentage points on a year-over-year basis, primarily driven by higher royalties and profit share due to changes in sales mix.

Speaker Change: In the second quarter, we delivered a non-GAAP operating margin of 48, 2% as a percentage of product sales with total non-GAAP operating expenses, increasing 30% year over year.

Speaker Change: The end of 2025. This includes $1 4 billion of debt retired in the second quarter and 2.0 billion year to date.

Speaker Change: Our non-GAAP tax rate decreased one five percentage points year over year to 14, 9% primarily.

Speaker Change: non-GAAP cost of sales as a percent of product sales increased <unk> four percentage points on a year over year basis, primarily driven by higher royalties and profit share due to changes in sales mix non-GAAP R&D spending in the second quarter increased 30% year over year as we strategically invested in the late stage pipeline.

Speaker Change: Primarily due to the change in sales mix from the inclusion of horizon.

Speaker Change: In the second quarter of 2024, the company generated $2 $2 billion of free cash flow a decrease of $3 8 billion a decrease from $3 8 billion in the previous year driven by the timing of tax payments in 2023 federal tax payments include.

Bob Bradway: Non-GAAP R&D spending in the second quarter increased 30% year-over-year as we strategically invested in the late-stage pipeline, including Meritide, Roka Tinlamab, and Bhima Ritusamab, as well as Horizon Acquired Program. Non-GAAP SG&A expenses increased 36% year-over-year, primarily driven by the addition of Horizon. Excluding the addition of Horizon, non-GAAP SG&A expenses increased 14% year-over-year driven by investment in Repatha, Otesla, and Avenity. Our non-GAAP OI&E resulted in a $700 million expense, up $400 million year-over-year, almost entirely due to increased interest expenses from the Horizon acquisition.

Speaker Change: Including maritime broker <unk>, and BMO rituximab as well as horizon acquired program.

Speaker Change: Adding a repatriation tax were made in the fourth quarter.

Speaker Change: As in 2020 for these payments were made in the second quarter.

Speaker Change: Our horizon integration is progressing well and we expect to reach $500 million in pre tax synergies by year, three post acquisition with roughly 50% to be realized by the end of this year.

Speaker Change: We expect accretion to non-GAAP earnings per share in 2024.

Speaker Change: We continue to execute on our capital allocation priorities.

Bob Bradway: We remain on track to deleverage, with a line of sight to retiring greater than $10 billion of debt by the end of 2025. This includes $1.4 billion of debt retired in the second quarter and $2.0 billion year-to-date. Our non-GAAP tax rate decreased 1.5 percentage points year-over-year to 14.9%, primarily due to the change in sales mix from the inclusion of Horizon.

Speaker Change: We're investing in the best innovation, both internally and externally to rapidly advanced and innovative pipeline with multiple potentially first in class <unk> best in class medicines across the four therapeutic areas.

Speaker Change: As I said earlier this is reflected in our second quarter non-GAAP R&D spend of $1 4 billion, an increase of 30% year over year.

Second we continue investing in our business for long term growth, we are expanding capacity in our state of the art manufacturing facilities, including investments to support maritime.

Bob Bradway: In the second quarter of 2024, the company generated $2.2 billion of free cash flow, a decrease of $3.8 billion, a decrease from $3.8 billion in the previous year, driven by the timing of tax payments. In 2023, federal tax payments, including our repatriation tax, were made in the fourth quarter, whereas in 2024, these payments were made in the second quarter. The Horizon integration is progressing well, and we expect to reach $500 million in pre-tax synergies by year three post-acquisition, with roughly 50% to be realized by the end of this year.

Speaker Change: Beyond manufacturing, we are opening a new global technology, and innovation Center in Hyderabad, India, which will attract talent at scale and accelerate digital capabilities across the organization.

Speaker Change: Including artificial intelligence data science life Science and medical.

Speaker Change: And third we returned capital to shareholders as we paid competitive dividend of $2 25 per share in the second quarter. This represented a 6% increase compared to 2023.

Bob Bradway: We expect a decline in non-GAAP earnings per share in 2024. We continue to execute on our capital allocation priorities. We're investing in the best innovation, both internally and externally, to rapidly advance an innovative pipeline with multiple potentially first in class and or best in class medicines across the four therapeutic areas.

Speaker Change: Turning to the outlook for the business for 2024 on Slide 29, we expect our 2020 for total revenues in the range of 32, eight to $33 8 billion and non-GAAP earnings per share between $19 10.

Speaker Change: $20 in handsets.

Speaker Change: I will mention a few considerations as you model the remainder of 2024.

Bob Bradway: As I said earlier, this is reflected in our second quarter non-GAAP R&D spend of $1.4 billion, an increase of 30% year over year. Second, we continue investing in our business for long-term growth. We are expanding capacity in our state-of-the-art manufacturing facilities, including investments to support Meritize. Beyond manufacturing, we are opening a new global technology and innovation center in Hyderabad, India, which will attract talent at scale and accelerate digital capabilities across the organization, including artificial intelligence, data science, life science, and medical. And third, we returned capital to shareholders as we paid competitive dividends of $2.25 per share in the second quarter.

Speaker Change: On revenues, we expect mid single digit growth quarter over quarter in the fourth quarter compared to Q3.

Speaker Change: Our full year non-GAAP R&D expenses are now expected to increase more than 25% year over year as we further invest in our late stage pipeline to support multiple late stage studies underway across all therapeutic areas.

Speaker Change: As a result, we now project our full year non-GAAP operating margin as a percentage of product sales to be roughly 47% with Q3 operating margin lower than Q2.

Speaker Change: Total non-GAAP operating expenses for the third quarter are expected to grow at a similar rate to the first two quarters of this year.

Speaker Change: We expect <unk> to be approximately $2 $5 billion, which includes the interest expense related to the $28 billion of debt raise for the horizon acquisition we.

Speaker Change: In the second quarter. This represented a 6% increase compared to 2023.

Bob Bradway: This represented a 6% increase compared to 2023. Turning to the outlook for the business for 2024 on slide 29, we expect our 2024 total revenues to be in the range of $32.8 to $33.8 billion, with non-GAAP earnings per share between $19.10 and $20.10. I will mention a few considerations as you model the remainder of 2024.

Speaker Change: Turning to the outlook for the business for 2024 on slide 29.

Speaker Change: We continue to expect the non-GAAP tax rate to be in the 15% to 16% range, including the full year benefits associated with the inclusion of the horizon business.

Speaker Change: We expect our 2020 for total revenues in the range of 32, eight to $33 8 billion and non-GAAP earnings per share between $19 10.

Speaker Change: As we have previously indicated we have initiated activities to further expand maritime manufacturing capacity.

Speaker Change: And $20 10.

Speaker Change: I will mention a few considerations as you model the remainder of 2024 on revenues, we expect mid single digit growth quarter over quarter in the fourth quarter compared to Q3.

Bob Bradway: On revenues, we expect mid-single-digit growth quarter over quarter in the fourth quarter compared to Q3. Our full-year non-GAAP R&D expenses are now expected to increase more than 25% year-over-year as we further invest in our late-stage pipeline to support multiple late-stage studies underway across all therapeutic areas. Total non-GAAP operating expenses for the third quarter are expected to grow at a similar rate to the first two quarters of this year. We expect OI&E to be approximately $2.5 billion, which includes the interest expense related to the $28 billion of debt raised for the Horizon acquisition.

Speaker Change: To support these initial efforts, we now expect capital expenditures of $1 3 billion in 2024 versus our most recent guidance of one one to $1 2 billion.

Speaker Change: Our long term outlook remains robust and I am grateful to our 27000 plus colleagues worldwide for their dedication to screen patients.

Speaker Change: This concludes our financial update.

Speaker Change: As a result, we now project our full year non-GAAP operating margin as a percentage of product sales to be roughly 47% with Q3 operating margin lower than Q2.

Speaker Change: We will now begin our Q&A session Julianne, please remind our participants of the process. Thank.

Julianne: Thank you.

Julianne: Thank you if you would like to ask a question. Please press star followed by one on your telephone keypad.

Speaker Change: Total non-GAAP operating expenses for the third quarter are expected to grow at a similar rate to the first two quarters of this year.

Julianne: For any reason you would like to turn that question. Please press star followed by one.

Julianne: To ask a question press star one.

Speaker Change: Our first question comes from year round, whereby from TD Cowen. Please go ahead. Your line is open.

Kieran: Great. Thank you.

Kieran Tully: Nice result, thanks, so much.

Bob Bradway: We continue to expect the non-GAAP tax rate to be in the 15-16% range, including the full-year benefits associated with the inclusion of the Horizon business. As we have previously indicated, we have initiated activities to further expand Meritide manufacturing capacity. To support these initial efforts, we now expect capital expenditures of $1.3 billion in 2024 versus our most recent guidance of $1.1 to $1.2 billion. Our long-term outlook remains robust, and I am grateful to our 27,000-plus colleagues worldwide for their dedication to serving patients. This concludes our financial update. We will now begin our Q&A session. Julianne, please remind our participants of the process.

Speaker Change: Maybe a question for you actually I wanted to start with the <unk> and we noticed a few things.

Kieran Tully: Study.

Kieran Tully: <unk> two <unk>.

Speaker Change: Completion around mid May and engine just posted a whole bunch of new job postings for gmg and Youll have a slot on October 15th at DMG.

Kieran Tully: <unk> the data.

Kieran Tully: As you know that Youre doing steroid tapering nissin trial design, but you also on the.

They bring in the other two indications pneumonia IGT for can you talk a little bit sort of what are you. What are you hoping to see and what do you expect from the data. Thank you.

Speaker Change: Thank you your own for the question and for following the program so closely.

Speaker Change: We're excited about the CD 19, B cell depleting monoclonal antibody is showing.

Speaker Change: <unk> activity. The result in <unk> related disease is a bellwether and it's quite dramatic with a hazard ratio of <unk> three a P value of what five to the minus seven.

Operator: Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If, for any reason, you would like to remove that question, please press star followed by one. Again, to ask a question, press star one. Our first question comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open.

Speaker Change: This was a stunning result.

First positive phase III for patients with ITG for related diseases as you nicely picked up in your question one of the opportunities of our pleasure <unk>.

Yaron Werber: Great, thank you, and a very nice result. Thanks so much.

Speaker Change: Patients off steroids and this is therefore, a predefined ambition of <unk> now in both IGT <unk> four related disease setting in that study as well as in the generalized myasthenia gravis study.

Jay Olson: Jay, maybe a question for you actually. I want to start with Flynn's, and we noticed a few things. The MINT study was supposed to be completed around mid-May, and Amgen just posted a whole bunch of new job postings for GMG, and you have a slot on October 15th at the MGFA to present the data. As you noted, you're doing steroid tapering. It's a different trial design, but you also did steroid tapering in the other two indications, NMO and IgG4. Can you talk a little bit about what you are hoping to see and what you are expecting to see from the data? Thank you.

Speaker Change: Now these results wont be available until the second half of this year and so I have no further update on that timing of the do stay tuned we're still hopeful that this once every six months 2019, b cell depleting therapy there.

<unk> substantially from available treatments like steroids, and other b cell targeted therapies and make a big difference for these patients.

Speaker Change: And let's go to the next question.

Thank you. Our next question comes from <unk> Richter from Goldman Sachs. Please go ahead. Your line is open.

Jay Olson: Thank you, Yaron, for the question and for following the program so closely. We're very excited about Eplizna.

Speaker Change: Good afternoon. Thanks for taking my question just following up here on year round could you speak to the clinical bar for our plans on myasthenia gravis, both on a placebo adjusted basis and also on absolute basis, given the notable steroid taper, which which I believe the other therapy did not.

Jay Olson: This CD19 B-cell-depleting monoclonal antibody is showing remarkable activity. The results in IgG4-related diseases of the bellwether are quite dramatic. It has a ratio of 0.13, a p-value of, what? 5 to the minus 7. This was a stunning result and the first positive phase 3 result for patients with IgG4-related diseases. As you picked up in your question, one of the opportunities of Oplizna is to get patients off steroids, and this is therefore a predefined ambition of Oplizna in both the IgG4-related disease setting in that study, as well as in the generalized myosinia gravis setting.

Speaker Change: Have included in their design and with regard to this MTF any scientific session meeting should we expect top line results.

Speaker Change: For that presentation. Thank you.

Speaker Change: Okay.

Speaker Change: I think <unk> as I just mentioned the euro we won't be providing further guidance on the timing of the results from the <unk> study the study in myasthenia gravis do stay tuned.

Jay Olson: Now, these results won't be available until the second half of this year, and so I have no further update on that timing, but do stay tuned. We're so hopeful that this, you know, once every six months, TD19 B-cell depleting therapy can differentiate substantially from available treatments like steroids and other B-cell targeting therapies and make a big difference for these patients.

Speaker Change: And as also as shared knowing that.

Speaker Change: Patients with myasthenia gravis are repeatedly in.

Speaker Change: Many many months of treatment.

Speaker Change: <unk> by the requirement for persistent steroids, we built in.

Speaker Change: A taper steroids onto this study.

Speaker Change: And.

Speaker Change: These results to read out in the second half of this year, we will bring to light exactly how successful we are.

Salveen Richter: Okay, Julianne, let's go to the next question. Thank you, Yaron. Our next question comes from Salveen Richter from Goldman Sachs.

Speaker Change: Liberating patients from steroids with.

Jay Olson: Thank you, Yaron. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead, your line is open.

Speaker Change: Every six months.

Speaker Change: Julianne go to next question please.

Salveen Richter: Please go ahead. Your line is open. Good afternoon. Thanks for taking my question. Just following up here on your own, could you speak to the clinical bar for a cleanser?

Evan <unk>: Thank you. Our next question comes from Evan <unk> from BMO capital markets. Please go ahead. Your line is open.

Evan <unk>: Alright. Thank you so much for taking my question well not a huge growth driver I was hoping if you could.

Evan <unk>: <unk> on some of your negotiations with CMS on Enbrel on many of your peers are pleased with kind of a fair price that they negotiated with CMS do you feel the same way I'd also love to know how youre thinking about the impact of part D. Redesign. Thank you so much.

Evan <unk>: Thanks, Evan for the question, it's Murdo here.

Jay Olson: Thanks, Salveen. As I just mentioned to Yaron, we won't be providing further guidance on the timing of the results from the EPLISNAS study, the mid-study of myasthenia gravis, but do stay tuned. And as I also shared, knowing that patients with myasthenia gravis are repeatedly and over many, many months of treatment challenged by the requirement for persistent steroids, we built in a taper on steroids into this study. And these results, to be read out in the second half of this year, will bring to light exactly how successful we are at liberating patients from steroids with every six months of EPLISNAS. Julianne, we'll go to the next question, please. Thank you, Salveen. Our next question comes from Evan Seigerman from BMO Capital Markets. Please go ahead. Your line is open.

Evan <unk>: Overall enbrel continues to do well in the market despite.

Evan <unk>: Very competitive market in Psoriatic arthritis, and rheumatoid arthritis.

Evan <unk>: We also continue to have relatively stable volume despite all.

Evan <unk>: All of the conversion that's going on in that aluminum that with Biosimilars. So we're quite pleased with.

Evan <unk>: Prescribers adoption and continued value of Enbrel safety, and Tolerability, which is well established over a long periods of time there are many many years of experience.

Speaker Change: We built in.

Speaker Change: Taper steroids onto this study.

Speaker Change: <unk>.

Speaker Change: These results are to readout in the second half of this year, we will bring to light exactly how successful we are.

Speaker Change: The process with CMS has concluded.

Speaker Change: Did have a price I would just remind you that roughly 25% of enbrel revenues come from Medicare part D. So that will in part mitigate the impact of the CMS.

Speaker Change: At liberating patients from steroids with.

Speaker Change: Every six months so pleasant.

Speaker Change: Julianne go to next question please.

Speaker Change: Thank you. Our next question comes from Evan <unk> from BMO capital markets. Please go ahead. Your line is open.

Speaker Change: Price reduction.

Speaker Change: And we continue to.

Speaker Change: I see that this is not a good mechanism to incentivize.

Evan: Alright. Thank you so much for taking my question well not a huge growth driver I was hoping if you could.

Speaker Change: And reward innovation and.

Evan: <unk> on some of your negotiations with CMS on Enbrel. Many of your peers. We're pleased with kind of a fair price that they negotiated with Tms can you feel the same way. We would also love to know how youre thinking about the impact of part D. Redesign. Thank you so much.

Speaker Change: It does not resemble.

Speaker Change: Sure.

Speaker Change: One would commonly described as a negotiation. So we've concluded that process and we continue to look to help patients and support them with enbrel in the market and we will watch the part D. Redesign closely we will look to see how pbms redesigning their formularies and we will look to.

Murdo Gordon: Thanks, Evan, for the question. It's Murdo here.

Speaker Change: Thanks, Evan for the question as Murdo here.

Speaker Change: Overall enbrel continues to do well in the market despite.

Speaker Change: Very competitive market in Psoriatic arthritis, and rheumatoid arthritis.

Speaker Change: See how patients are impacted by the new model, while the cap may help the out of pocket for many patients may actually rise solar we're watching it closely.

Murdo Gordon: Overall, Enbrel continues to do well in the market, despite a very competitive market in psoriatic arthritis and in rheumatoid arthritis. We also continue to have relatively stable volume, despite all of the conversion that's going on in adalimumab with biosimilars. So we're quite pleased with prescribers' adoption and continued value of Enbrel's safety and tolerability, which is well established over a long period of time, many, many years of experience. The process with CMS has concluded.

Speaker Change: We also continue to have relatively stable volume despite all.

Speaker Change: All of the conversion that's going on in that aluminum that with Biosimilars. So we're quite pleased with.

Speaker Change: Prescribers adoption and continued value of Enbrel safety, and Tolerability, which is well established over a long period of time that many many years of experience.

Speaker Change: So yes next question please.

Speaker Change: Thank you Evan our next question comes from Mike <unk> from Jefferies. Please go ahead. Your line is open.

Speaker Change: Thank you for the question.

Murdo Gordon: We do have our price. I would just remind you that roughly 25% of Enbrel revenues come from Medicare Part D. So that will, in part, mitigate the impact of the CMS price reduction. And we continue to see that this is not a good mechanism to incentivize and reward innovation, and that it does not resemble what one would commonly describe as a negotiation.

Speaker Change: Pivoting to obesity I know that you are on track for data later this year for the injectable product, which you claim is differentiated.

Speaker Change: The process with CMS has concluded.

Speaker Change: Didn't have a price I would just remind you that roughly 25% of enbrel revenues come from Medicare part D. So that will in part mitigate the impact of the CMS.

Speaker Change: Other competitors have moved quickly on both of them.

Speaker Change: Their programs with Injectables, but also oral <unk> multiple companies.

Speaker Change: Can you just comment about how you feel about your positioning in that space given others have multiple products moving to late stage and how you feel you can position yourself here given just 133. Thank you.

Speaker Change: Price reduction.

Murdo Gordon: So we've concluded that process, and we continue to look to help patients and support them with Enbrel on the market. And we will watch the Part D redesign closely. We will look to see how PBMs redesign their formularies, and we will look to see how patients are impacted by the new model. While the cap may help, the out-of-pocket for many patients may actually rise.

Speaker Change: Thanks, Mike why don't I get started and Murdo, perhaps you could add on at the end.

Murdo: We are very pleased with the results that we've seen at the interim.

Murdo: The overall conduct of the phase III study.

Murdo: Though there has been no further analysis since the interim as of the interim all the arms reactive dropout has not been an issue.

Murdo: We saw a differentiated profile with maritime and remain confident that this medicine can address significant important unmet medical need in obesity obesity related conditions and in particular at your diabetes as shared earlier in the call.

Murdo: There is no question that there is a <unk>.

Speaker Change: Democratize the broad base of innovation in this space.

Mike Yee: So we're watching it closely. Thank you, Evan. Our next question comes from Mike Yee from Jefferies. Please go ahead. Your line is open. Thank you for the question. Pivoting to obesity, I know that you are on track for data later this year.

Mike Yee: Thank you, Evan. Our next question comes from Mike Yee from Jefferies. Please go ahead; your line is open. Thank you for the question.

And potentially oral medicines could serve to address some of that still vast and remaining unmet need and we followed these programs very closely.

Speaker Change: Still.

Speaker Change: The development of Maritime is advancing very briskly as we now move to rapidly initiate a broad phase III program.

Speaker Change: And we remain confident in what maritime can offer for patients with obesity related conditions as well as diabetes mirror.

Jay: Thanks, Jay I think.

Jay: Data continues to emerge in the obesity in obesity related conditions landscape.

Speaker Change: And show clear benefit.

Jay Olson: Thanks, Mike. Why don't I get started, and Murdo, perhaps you could add on at the end?

Speaker Change: Reducing weight.

Speaker Change: Will indeed with <unk> based mechanisms will indeed improve outcomes in many disease setting so.

Jay Olson: You know, we are very pleased with the results that we've seen at the interim and with the overall conduct of the phase two study. Though there's been no further analysis since the interim, as of the interim, all the arms were active, dropout had not been an issue, and we saw a differentiated profile with Meritide and remain confident that this medicine can address significant and important unmet medical needs for obesity, obesity-related conditions, and in particular type 2 diabetes, as shared earlier in the call.

Speaker Change: That continues to expand the market and grow it.

Jay: I do agree with Jay that there will be patients who may seek oral options, but I continue to believe that we have a very good differentiated product here and that monthly dosing or even less frequently will continue to help patients persist.

Jay: On their weight loss medication and achieve.

Jay Olson: There's no question that there is quite a democratized and broad base of innovation in this space, and potentially, oral medicines could serve to address some of that still vast and remaining unmet need, and we follow these programs very closely. Still, the development of Meritide is advancing very briskly as we now move to rapidly initiate a broad phase three program, and we remain confident in what Meritide can offer for patients with obesity-related conditions as well as diabetes. Murdo?

Jay: Hopefully some of those hard endpoint risk reductions that we're seeing in clinical trial presentations.

Speaker Change: I would say that we.

Speaker Change: We would.

Speaker Change: Importantly, we have a really good convenient dosing here with a single.

Speaker Change: 10.

Speaker Change: Working on and that weekly injectable products are probably more vulnerable to oracle's than than a convenient monthly dosing.

Julianne: Next question please julianne.

Julianne: Thank you. Our next question comes from Omar <unk> from Evercore ISI. Please go ahead. Your line is open.

Murdo Gordon: Yes, thanks, Jay. I think the data continues to emerge in the obesity and obesity-related conditions landscape and shows, you know, clear benefits that reducing weight will indeed, with GLP-1-based mechanisms, improve outcomes in many disease settings. So, you know, that continues to expand the market and grow it. I do agree with Jay that there will be patients who may seek oral options, but I continue to believe that we have a very good differentiated product here and that monthly dosing or even less frequently will continue to help patients persist on their weight loss medication and achieve, hopefully, some of those hard endpoint risk reductions that we're seeing in clinical trial presentations.

Hi, guys. Thanks for taking my question I wanted to focus on maritime if I may a two part question first it looks like your competitors are moving forward to phase III on either smaller datasets or lesser further along from a phase II phase III perspective.

Speaker Change: Just curious why.

Speaker Change: You thought you definitely need at 52 week data was that mostly conservatism or is that some FDA feedback as well.

Speaker Change: And then also on Capex I feel like the 150 million guidance increase seems.

Speaker Change: Seemed relatively trivial, but it does imply capex being up 80% over first half could you. Please expand on whether its API related or something else you have in mind. Thank you very much.

Speaker Change: Yes, Thanks, Pete why don't I start on.

Speaker Change: On the.

Speaker Change: The overall development plan for maritime and the value of the phase two data that we'll have at the end of this year alumina as you know.

Murdo Gordon: I would say that we would purport to have a really good, convenient dosing here with the single-use pen that we're working on and that weekly injectable products are probably more vulnerable to orals than a convenient monthly dosing.

Speaker Change: This medicine coming out of phase one shown quite remarkable impact on obesity with a dramatic reduction in BMI definitely proved quite durable. After just three doses of maritime in that phase. One study, we saw persistent weight loss really out of 150 days or more.

Umer Raffat: Thank you, Mike. Our next question comes from Umer Raffat from Evercore ISI.

Speaker Change: Some doses.

Murdo: A phase II study is a much larger concern. This is a 592 piece patient study. It has 11 arm the test monthly or as Murdo said, even less frequent dosing.

Umer Raffat: Hi guys, thanks for taking my question. I wanted to focus on Meritide, if I may, a two-part question.

Umer Raffat: Please go ahead. Your line is open. Hi guys.

Jay Olson: First, it looks like your competitors are moving forward to phase three on either smaller data sets or less advanced from a phase two, phase three perspective. Just curious why you thought you definitely needed 52-week data. Was that mostly conservatism, or was that some FDA feedback as well? And then also on CAPEX, I feel like the $150 million guidance increase seems relatively trivial, but it does imply CAPEX being up 80% over the first half. Could you please expand on whether it's API related or something else you have in mind? Thank you very much.

Part two that allows us to really follow up on this durability signal and it will allow the precision selection of dose or doses that patients and practitioners I'm really desire.

Murdo: This also conforms to.

Murdo: Regulatory.

Murdo: Sorry requirements entering into phase III.

Speaker Change: Homeowners Peter on Capex as we previously indicated.

Speaker Change: We have initiated activities to further expand.

Speaker Change: Maritime manufacturing capacity to support those efforts.

Jay Olson: Yes, thanks, Pete, why don't I start on the overall development plan for Maritide and the value of the Phase 2 data that we'll have at the end of this year. Umer, as you know, this medicine coming out of Phase 1 showed a quite remarkable impact on obesity with a dramatic reduction in BMI, and it actually proved quite durable after just three doses of Maritide.

Speaker Change: I said, we now expect Capex of $1 3 billion and 24 versus the most recent guidance.

Speaker Change: Which was $1 one to $1 2 billion.

Speaker Change: Julian next question please.

Julian: Thank you Omar our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open.

Jay Olson: Oh, Hey, thanks for taking the question and congrats on all the progress, especially in your bite platform.

Jay Olson: In that Phase 1 study, we saw persistent weight loss really out for 150 days or more at some doses. The Phase 2 study is a much larger concern. This is a 592-patient study with 11 arms.

Jay Olson: Can you talk about any feedback youre getting from clinicians on the <unk> launch and potential lessons learned from Linde side of that you can leverage from delta, especially since you're launching <unk> and developing a sub Q formulation. Thank you.

Jay Olson: It tests monthly or, as Murdo said, even less frequent dosing. It has a Part 2 that allows us to really follow up on this durability signal. It will allow the precision selection of dose or doses that patients and their practitioners really desire. This also conforms to regulatory requirements entering into Phase 3.

Murdo: Taking on a couple of parts Murdo you want to share what we're learning from the launch yes. Thanks for the question Jay <unk>.

Speaker Change: Obviously, it's very early given that this was a mid may approval, but.

Speaker Change: I have to say we are extremely pleased with.

Speaker Change: However, both thought leaders and community oncologists are receiving and downturn in the market there their clinical conviction is very high.

Jay Olson: Umer's Peter on CapEx, as we previously indicated. We have initiated activities to further expand maritime manufacturing capacity and support those efforts. I said we now expect CapEx of $1.3 billion in 2024 versus the most recent guidance, which was 1.1 to 1.2 billion.

Speaker Change: They are moving quickly to establish care pathways for these patients given the monitoring requirement for in Delta.

Speaker Change: And.

Speaker Change: This is this disease setting as you know is a really difficult disease setting patients can progress relatively rapidly after.

Jay Olson: Julian, next question, please. Thank you, Umer. Our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open. Oh, hey, thanks for taking the call.

Jay Olson: Thank you, Umer. Our next question comes from Jay Olson from Oppenheimer. Please go ahead. Your line is open.

Speaker Change: Platinum based chemotherapy in the frontline and so.

Speaker Change: We're obviously moving very quickly with our medical teams our account management teams and our sales organization.

Speaker Change: Build rapid awareness and to help.

Speaker Change: Can you talk about any feedback youre getting from clinicians on the EMS altura launch and potential lessons learned from <unk> that you can leverage for in Delta, especially since you're launching blend site now and B a L L and developing a sub Q formulation. Thank you.

Speaker Change: Both academic and community oncology accounts.

Speaker Change: Be able to treat patients.

Speaker Change: Easily and safely.

Speaker Change: And have the appropriate settings for careful up so very early but.

Murdo Gordon: Take it in a couple of parts here, Murdo. Do you want to share what we're learning from the launch?

Speaker Change: Thank you and then a couple of parts Murdo you want to share what we're learning from the launch yes. Thanks for the question Jay.

Speaker Change: This product is seen as a major transformation in this disease setting.

Murdo Gordon: Thanks for the question, Jay. Obviously, it's very early given that this was a mid-May approval, but I have to say we are extremely pleased with how both thought leaders and community oncologists are receiving MDELTRA in the market. Their clinical conviction is very high.

Speaker Change: Yes, thanks for the question Jay.

Murdo: Obviously, it's very early given that this was a mid may approval, but.

You picked up on something really interesting and that's leveraging the learnings upland silo and this really is a platform capability that we enjoy with bi specific T cell engagements.

Murdo: I have to say we are extremely pleased with.

Speaker Change: Both thought leaders and community oncologists are receiving and delta in the market there.

Speaker Change: And already in the development of indulge after its first approval, we are seeing significant read through of the blend Sino lessons.

Speaker Change: Our clinical conviction is very high.

Murdo Gordon: They are moving quickly to establish care pathways for these patients given the monitoring requirement for MDELTRA, and this disease setting, as you know, is a really difficult disease setting. Patients can progress relatively rapidly after platinum-based chemotherapy on the front line, and so we're obviously moving very quickly with our medical teams, our account management teams, and our sales organization to build rapid awareness and to help both academic and community oncology accounts be able to treat patients easily and safely and have the appropriate settings for care follow-up. So, very early, but this product is seen as a major transformation in this disease setting. Jay? Yeah, no. Thanks for the question, Jay.

Speaker Change: They are moving quickly to establish care pathways for these patients given the monitoring requirement for in Delta and.

Speaker Change: Moving from later lines of therapy to earlier lines of therapy to drive efficacy in the setting of reduce tumor burden.

Speaker Change: This is this disease setting as you know is a really difficult disease setting patients can progress relatively rapidly after.

The utility of these medicines in combination, which is so much easier to access and <unk> and other complex modalities CLEC car T in and moving these medicines to the point of therapy, where they can have the greatest impact, namely frontline.

Speaker Change: Platinum based chemotherapy in the frontline and so we're obviously moving very quickly with our medical teams our account management teams and our sales organization.

Speaker Change: So pathways to reduce monitoring J, we're leveraging all the learnings of insight to drive and expedite the development of an adult trial to be a component of frontline.

Speaker Change: To build rapid awareness and to help.

Speaker Change: Both academic and community oncology accounts being able to treat patients easily and safely.

Speaker Change: So lung cancer therapy, both with extensive stage and limited stage disease and as.

Speaker Change: As more of a shared.

Speaker Change: We do this work really quite inspired by the impact of the medicine, even so early in its launch significant demands learn and access and offer this medicine.

Speaker Change: And have the appropriate settings for careful up so very early but.

Jay: This product is seen as a major transformation in this disease setting Jay Yes, I do.

Jeff: And Jeff I'd, just add that when it comes to Azalea Rita I think your question applies well there too so stay tuned we'll talk more about your room Mega stated emerge, but we're optimistic about how we can apply the lessons of blend in Belgium that is well, let's go to the next question.

Jay Olson: You picked up on something really interesting, and that's, you know, leveraging the learnings of Blinn-Saito. I mean, this really is a platform capability that we enjoy with bi-specific T cell engagers. And already, in the development of Indeltra after its first approval, we are seeing significant read through of the Blinn-Saito lesson, moving from later lines of therapy to earlier lines of therapy to drive efficacy in the setting of reduced tumor burden. The utility of these medicines in combination, which is so much easier to access and assess than other complex modalities, say like CAR-T, and moving these medicines to the point of therapy where they can have their greatest impact, namely frontline, also pathways to reduce monitoring.

Speaker Change: Thanks for the question Jay.

Speaker Change: You picked up on something really interesting and thats leveraging the learnings upland silo and this really is a platform capability that we enjoy with bi specific T cell engagements.

Speaker Change: And already in the development of <unk>. After its first approval, we are seeing significant read through of the <unk> lessons.

Thank you J. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Mohit Bansal: Great. Thank you very much for taking my question I.

Speaker Change: Moving from later lines of therapy to earlier lines of therapy to drive efficacy in the setting of reduce tumor burden. The utility of these medicines in combination, which is so much easier to access and assess and other complex modalities like car T and.

Mohit Bansal: I have a question for Jay.

Mohit Bansal: Again on very tight.

Mohit Bansal: Is there any reason to think that magnetite may or may not exhibit a difference.

Mohit Bansal: <unk> profile.

Speaker Change: The <unk> bone on such as lipid blood pressure on CD active protein and how important is benefit on both parameters.

Speaker Change: And moving these medicines to the point of therapy, where they can have the greatest impact, namely frontline also pathways to reduce monitoring Jay we are leveraging all the learnings of insight to drive and expedite the development of <unk> to be a component of frontline on small cell lung cancer therapy, both with extensive stage.

Speaker Change: You design your phase III trial, something like outcomes trial.

Jay Olson: Jay, we are leveraging all the learnings of Lin-Syto to drive and expedite the development of Imdeltra to be a component of frontline small cell lung cancer therapy for both extensive stage and limited stage disease. And as Myrtle shared, we do this work really quite inspired by the impact of the medicine even so early in its launch, significant demand to learn, access, and offer this medicine.

Speaker Change: Thank you.

Speaker Change: Yes. Thank you Mohit I can surely understand the interest and indeed, we are making all of these measurements and more.

Speaker Change: Dimensionalize, what we mean when we say differentiated profile at this time, we're still focused on completing this ongoing and well conducted maritime phase II study of that you expect to learn this and more.

Speaker Change: And limited stage disease and as more of a shared we do this work really quite inspired by the impact of the medicine, even so early in its launch.

Speaker Change: <unk> demand to learn and access and offer this medicine.

Jay Olson: And Jay, I might just add that when it comes to Zaireta Omega, I think your question applies well there, too. So stay tuned. We'll talk more about Zaireta Omega as data emerge, but we're optimistic about how we can apply the lessons of Blinn and Indulger to that as well.

Jeff: And Jeff I'd, just add that when it comes to us because I think your question applies well there too. So stay tuned we'll talk more about how you really make us data emerge, but we're optimistic about how we can apply the lessons of blend in delta to that is well, let's go to the next question.

Speaker Change: When ultimately.

Speaker Change: We're able to be in a position to share the outcomes of part a of the phase II study.

Speaker Change: Taking a comprehensive assessment.

Speaker Change: Optimize dose and schedule impacts of this medicine.

Julian: Julian next question please.

Mohit Bansal: Thank you, Jay. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead, your line is open. Great, thank you very much for joining us.

Mohit Bansal: Let's go to the next question. Thank you, Jay. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Great, thank you very much for taking my question. I have a question for Jay. Again, on maritime, is there any reason?

Speaker Change: Thank you J. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Speaker Change: Thank you Mohit <unk>. Our next question comes from Gregory <unk> from RBC Capital markets. Please go ahead. Your line is open.

Mohit Bansal: Great. Thank you very much for taking my question.

Gregory: Great. Thanks, congratulations on the quarter and thanks for taking my question.

Mohit Bansal: I have a question for Jay.

Speaker Change: Hi.

Speaker Change: Again, our maritime.

Gregory: My question is just on the obesity franchise as you and the team had mentioned to expect one of the early RBC program to enter clinical development. Later this year. Just curious if you can elaborate on what lens you are using to nominate that that first or that next program I'd imagine, it's rather complex and the assessment and any color.

Speaker Change: Is there any reason to think that magnetite may or may not exhibit.

Speaker Change: Different profile.

Speaker Change: Say, hey go get that bone on Pandemics, such as lipid blood pressure on CD active protein and how important is benefit on both parameters.

Speaker Change: While you're designing your phase III trial, something like outcome trial.

Speaker Change: Have on determining that choice and how to take that forward would be great. Thank you.

Thank you.

Jay Olson: Yeah, thank you, Mohit. I can surely understand the interest. And indeed, we are making all these measurements and more. But we won't dimensionalize what we mean when we say differentiated profile at this time. We're still focused on completing this ongoing and well-conducted Meritide Phase 2 study, but we do expect to learn this and more when, ultimately, we are able to share the outcomes of Part A of the Phase 2 study. We are taking a comprehensive assessment to optimize dose and schedule and impact of this medicine.

Speaker Change: Yes. Thank you Mohit I can surely understand the interest and indeed, we are making all of these measurements and more.

Gregory: Gregory Thank you Jay.

Gregory: And thanks for following the early pipeline in its development is developing very nicely and as we've shared our strategy and the development of obesity medicines and medicines for obesity related conditions. We're interested in really harvesting the insights of the incretin pathways, but also moving beyond this pathway to other novel targets some supported by genetic infra.

Speaker Change: We won't Dimensionalize, what we mean, when we say differentiated profile at this time, we're so focused on completing this ongoing and well conducted maritime phase III study of the two expect to learn this and more.

Speaker Change: Ultimately we're in.

Gregory: <unk>, but all of them supported by strong preclinical development packages and so it is a multifactorial assessment that leads to the decision to resource of medicine in human clinical investigation, but at a high degree of conviction thats required as the bars of horizon within our portfolio for that resource as well as in the field.

Speaker Change: Well to be in a position to share the outcome of the part a of the phase III studies.

Speaker Change: We are taking a comprehensive assessment of the optimized dosing schedule.

Speaker Change: Fact of this medicine.

Jay Olson: Julianne, next question please. Thank you, Mohit. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead. Your line is open. Great. Thanks. Congratulations on the quarter. And thanks for taking my question.

Julian: Julian next question please.

Gregory Renza: Thank you, Mohit. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead. Your line is open. Great.

Speaker Change: Thank you Mohit <unk>. Our next question comes from Gregory <unk> from RBC Capital markets. Please go ahead. Your line is open.

Gregory: <unk>.

Gregory: So more to follow on the mechanism and characteristics of this new medicine that we're intending to advance into clinical investigation in the second half of this year.

Gregory: Great. Thanks, congratulations on the quarter and thanks for taking my question.

Gregory: My question just on the obesity franchise as you and the team had mentioned to expect one of the early obesity program to enter clinical development. Later this year. Just curious if you could elaborate on what lens you are using to nominate that that first or that next program I'd imagine, it's rather complex and the assessment and any color you have.

Speaker Change: Our next question please.

Speaker Change: Thank you Gregory our next question comes from Chris Raymond from Piper Sandler. Please go ahead. Your line is open.

Speaker Change: Thanks.

Speaker Change: If I may another obesity question.

Speaker Change: Just on maritime and.

Speaker Change: On determining that choice and how to take that forward would be great. Thank you.

Speaker Change: I've heard you guys now talk for.

Speaker Change: A longtime about planning for a broad phase III program, but.

Gregory Renza: Gregory, thank you. This is Jay, and thanks for following the early pipeline and its development. It's developing very nicely.

Gregory: Gregory Thank you Jay.

Speaker Change: I don't think you guys have ever talked even in general generalities when exactly this will happen.

Speaker Change: And thanks for following the early pipeline in its development is developing very nicely and as we've shared our strategy and the development of obesity medicines medicines for obesity related conditions, we're interested in really harvesting the insights of the incretin pathways, but also moving beyond this pathway to other novel targets some supported by genetic <unk>.

Speaker Change: Can you maybe give a range here for when you anticipate.

Speaker Change: Kicking off enrollment in that program.

Speaker Change: Chris as you can expect we're focused now on completing the phase II trial, and moving as swiftly as appropriate into phase III. So we will have more to say that over the course of the.

Speaker Change: But all of them supported by strong preclinical development packages.

Speaker Change: Coming here you can appreciate it's a competitively intense field. So we're not we're not giving dates at this point.

Jay Olson: As we've shared our strategy for the development of obesity medicines and medicines for obesity-related conditions, we're interested in really harvesting the insights of the Incretin pathway but also moving beyond this pathway to other novel targets, some supported by genetic inferences, but all of them supported by strong preclinical development packages. And so it is a multifactorial assessment that leads to the decision to resource the medicine in human clinical investigation, but it's a high degree of conviction that's required as the bar is ever rising within our portfolio for that resource, as well as in the field. So more to follow on the mechanism and characteristics of this new medicine that we're intending to advance into clinical investigation in the second half of this year.

Speaker Change: And so it is a multifactorial assessment that leads to the decision to resource of medicine in human clinical investigation, but at a high degree of conviction thats required as the bars are rising within our portfolio for that resource as well as in the field.

Speaker Change: Next question please.

Speaker Change: Yeah.

Speaker Change: Our next question comes from Carter Gould from Barclays. Please go ahead. Your line is open.

Good afternoon. Thank you for taking the question for Peter.

Speaker Change: So more to follow on the mechanism and characteristics of this new medicine that we're intending to advance into clinical investigation in the second half of this year.

On August 2nd U S tax court entered a decision against Coke their litigation was often referenced as sort of the best benchmark for sort of what youre facing appreciating that you took the deposit earlier this year, but why shouldn't there be read through from that case, and maybe you could speak to your overall confidence on the outcome. Thank you.

Speaker Change: Our next question please.

Chris Raymond: All right, next question, please. Thank you, Gregory. Our next question comes from Chris Raymond on Piper Sandler. Please go ahead. Your line is open. Thanks, and, if I may, another obesity question.

Chris Raymond: Thank you, Gregory. Our next question comes from Chris Raymond on Piper Sandler. Please go ahead. Your line is open.

Speaker Change: Thank you Gregory our next question comes from Chris Raymond from Piper Sandler. Please go ahead. Your line is open.

Speaker Change: Thanks.

Speaker Change: Yeah, no. Thank you very much for the.

Speaker Change: If I may another obesity question.

Carter Gould: Question Carter.

Speaker Change: Just on maritime and.

Speaker Change: <unk> has changed in our evaluation of the case Court date set for November 4th we're confident in our position right, where we've always been we're confident in our reserves at an appropriate level.

Speaker Change: I've heard you guys talk for.

Speaker Change: A long time about planning for a broad phase III program, but.

Speaker Change: I don't think you guys have ever talked to even in general generalities when exactly this will happen.

Speaker Change: And what I would say is first of all I don't see.

Speaker Change: Can you maybe give a range here for when you anticipate.

Speaker Change: And Coke hasnt been as much in referenced and I won't get into making comparisons refer once in a while to the medtronic situation, but in general what we've seen is that the tax court in the last several years has reinforced the value of manufacturing.

Speaker Change: Kicking off enrollment in that program.

Chris Raymond: Chris, as you can expect, we're focused now on completing the phase two trial and moving as swiftly as appropriate into phase three. So we'll have more to say about that over the course of the coming year. You can appreciate it's a competitively intense field, so we're not giving dates at this point. Next question, please. Our next question comes from Carter Gould from Barclays. Please go ahead; your line is open. Good afternoon. Thank you for taking the time to

Speaker Change: Chris as Youre going to expect we're focused now on completing the phase III trial, and moving as quickly as appropriate into phase III, So well have more to say that over the course of the.

Speaker Change: The coming year you can appreciate it it's a competitively intense field. So we're not we're giving dates at this point.

Speaker Change: Puerto Rico, and so we look forward to.

Speaker Change: Saving our case, we're very confident where we're at.

Speaker Change: Okay next question please.

Speaker Change: And that's all we've got to say at this time no change we're at where we were in terms of confidence which is in the same place for the last two and a half for three years now.

Speaker Change: Yeah.

Carter Gould: Our next question comes from Carter Gould from Barclays. Please go ahead. Your line is open. Good afternoon.

Speaker Change: Our next question comes from Carter Gould from Barclays. Please go ahead. Your line is open.

Carter Gould: Good afternoon. Thank you for taking the question for Peter.

Speaker Change: [noise] Julian next question please.

Carter Gould: On August 2nd U S tax court entered a decision against Coke their litigation was often referenced does sort of the best benchmark for sort of what youre facing appreciating that you took the deposit earlier this year, but why shouldn't there be read through from that case, and maybe you could speak to your overall confidence on the outcome. Thank you.

Speaker Change: Thank you Carter. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Terence Flynn: Great. Thanks for taking the question Peter another one for you here.

Terence Flynn: I appreciate the incremental guidance on Capex, but just was wondering if you could speak directionally about margins in 2025, given the likely scope of maritime obesity program. Thank you.

Carter Gould: Yeah, no, thank you very much for the question, Carter. Nothing has changed in our evaluation of the case. Court dates are set for November 4th.

Speaker Change: Yeah, no. Thank you very much for the.

Carter Gould: Question Carter.

Speaker Change: Thing has changed in our evaluation of the case for a date set for November 4th we're confident in our position right, where we've always been we're confident in our reserves at an appropriate level.

Terence Flynn: Terence we don't as you know, we don't guide long term margins, but let me just comment.

Carter Gould: We're confident in our position, right where we've always been. We're confident our reserves are at an appropriate level. And what I would say is, first of all, I don't see, and Coke hasn't been as much of a reference, and I won't get into making comparisons. But we do refer once in a while to the Medtronic situation. But in general, what we've seen is that the tax court, in the last several years, has reinforced the value of manufacturing in Puerto Rico.

Speaker Change #101: On what Youre seeing this year I'm happy to speak to that I think it's important.

Speaker Change: And what I would say is first of all I don't see.

Speaker Change #102: At Amgen, we're committed to a capital allocation hierarchy.

Speaker Change: And Coke hasnt been as much a referenced and I won't get into making comparisons refer once in a while to the medtronic situation, but in general what we've seen is that the tax court in the last several years has reinforced the value of manufacturing.

Speaker Change #102: First investing in innovation and first internal innovation.

Speaker Change #102: And so with that in mind, Terence we've consistently said that we would flex up margin, which remember with us as a percentage of product sales net revenue. If there were opportunities to achieve strong after tax cash returns on our investment in excess of our hurdle rate and then we would communicate that ahead of time so.

Speaker Change: Puerto Rico, and so we look forward to.

Carter Gould: And so we look forward to stating our case. We're very confident where we are. And that's all we've got to say at this time. No change. We're at where we were in terms of confidence, which has been the same place for the last two and a half or three years now. Julian, next question, please. Thank you, Carter. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Speaker Change: <unk> our case, we're very confident where we're at.

Speaker Change: And that's all we've got to say at this time no change we're at where we were in terms of confidence which is in the same place for the last two and a half or three years now.

Terence Flynn: This year, we shared with you at the beginning of the year, we felt operating margin would be about 48%.

Terence Flynn: We see an opportunity here during the year to make some investments in.

Julian: Julian next question please.

Speaker Change: Thank you Carter. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Speaker Change #103: Research and development activities with an emphasis I would say on development, that's up 30% year over year in the quarter non-GAAP R&D.

Terence Flynn: Great, thanks for taking the time.

Terence Flynn: Great. Thanks for taking the question Peter another one for you here.

Speaker Change #103: Now see non-GAAP R&D spend up over 25% year over year for 24, which we think is great. Because you have heard about the deep mid and late stage pipeline, we have driving maritime and that deep mid and late stage pipeline.

Terence Flynn: I appreciate the incremental guidance on Capex, but just was wondering if you could speak directionally about margins in 2025, given the likely scope of the maritime obesity program. Thank you.

Speaker Change #103: These focused terence whether its this year next year on productivity and prioritization always looking for opportunities to generate capital to allocate the innovation we've got.

Terence Flynn: Terence, we don't, as you know, we don't guide long-term margins, but let me just comment on what you're seeing this year. I'm happy to speak to that, and I think it's important.

Julian: Terence.

Speaker Change: As you know we don't.

Peter: Guide long term margins, but let me just comment.

Speaker Change #103: Got a new program called technology and workforce strategy.

Terence: On what Youre seeing this year I'm happy to speak to that and I think it's important.

Speaker Change #103: We're moving along at speed and scale I spoke about opening a new talent and innovation center in Hyderabad, India, but we're doing everything we can to preserve that margin reallocate capital innovation and disciplined spenders of capital that Amgen noises that.

Terence Flynn: You know, we're, at Amgen, committed to a capital allocation hierarchy where we first invest in innovation and first internal innovation. And so with that in mind, Terence, you know, we've consistently said that we would flex our margin, which, remember, with us, it's a percentage of product sales, not revenue, if there were opportunities to achieve strong after-tax cash returns on our investment in excess of our hurdle rate, and that we would communicate that ahead of time. So this year, we shared with you at the beginning of the year that we felt the operating margin would be about 48%.

Speaker Change: At Amgen, we're committed to our capital allocation hierarchy, where are we.

Terence: First investing in innovation and first internal innovation.

Terence: And so with that in mind, Terence we have consistently said that we would flex up margin, which remember with us as a percentage of product sales net revenue. If there were opportunities to achieve strong after tax cash returns on our investment in excess of our hurdle rate and then we would communicate that ahead of time so.

Speaker Change #104: Our next question please.

Speaker Change #105: Thank you Darren our next question comes from Chris Schott from Jpmorgan. Please go ahead. Your line is open.

Chris Schott: Great. Thanks, very much just had a question on maritime <unk> and your plans in that phase II diabetes study company, obviously very excited about the broader opportunity for the drug but it does seem like diabetes as a more established market with maybe less of the capacity constraints that we've seen obesity. So can you just talk a little bit about what you think you need to see to be able to compete here in <unk>.

Terence: This year, we shared with you at the beginning of the year, we felt operating margin would be about 48%.

Terence Flynn: We see an opportunity here during the year to make some investments in research and development activities, with an emphasis, I would say, on development. That's up 30% year-over-year in the quarter for non-GAAP R&D. We now see non-GAAP R&D spend up over 25% year-over-year for 24, which we think is great because you've heard about the deep, mid, and late-stage pipeline we have driving Meritide and that deep, mid, and late-stage pipeline. We're always focused, Terence, whether it's this year or next year, on productivity and prioritization, always looking for opportunities to generate capital to allocate to innovation.

Speaker Change: We see an opportunity here during the year to make some investments in the research and.

Speaker Change: Development activities with an emphasis I would say on development, that's up 30% year over year in the quarter non-GAAP R&D, we now see non-GAAP R&D spend up over 25% year over year for 24, which we think is great. Because you have heard about the deep mid and late stage pipeline, we have driving maritime and that the mid end.

Speaker Change #107: Incumbents and can you also confirm this study is not needed to move forward in the phase III obesity studies and it's just completely separate program really in the diabetes piece of things. Thank you.

Speaker Change #107: I can take those two pieces again, Jay why don't you address the first piece and then Murdo feel free to jump in.

Speaker Change: Late stage pipeline, we're always focused Terence whether its this year next year on productivity and prioritization always looking for opportunities to generate capital to allocate to innovation.

Jay Olson: Yes, absolutely.

Murdo: As you are nicely identified a later this year, we will initiate an additional dedicated phase III study that will characterize maritime for the treatment of diabetes in patients with and without obesity.

Terence Flynn: We've got a new program called Technology and Workforce Strategy that we're moving along at speed and scale. I spoke about opening a new Talent Innovation Center in Hyderabad, India. So we're doing everything we can to preserve that margin, reallocate capital for innovation, and be the disciplined spenders of capital that Amgen always has been.

Speaker Change: We've got a new program called technology and workforce strategy.

Speaker Change: We're moving along at speed and scale I spoke about opening a new talent and innovation center in Hyderabad, India, but we're doing everything we can to preserve that margin reallocate capital innovation and B, the disciplined spenders of capital that Amgen noises that.

Speaker Change #108: This new study is not a gating step at all for the Phase III program for patients with obesity.

Speaker Change #108: But conforms to regulatory guidance and importantly allows us to optimize dosing for the diabetic patient where medically I can say and merlion.

Speaker Change: Our next question please.

Chris Schott: Thank you, Terence. Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open.

Chris Schott: All right, next question, please. Thank you, Terence. Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open. Great. Thanks very much. I just had a question on Maritide and your plans for it.

Speaker Change: Thank you Terence our next question comes from Chris Schott from J P. Morgan. Please go ahead. Your line is open.

Speaker Change #108: Suitable perspectives.

Speaker Change #109: I'm unaware of a highly efficacious monthly or less frequently administered medicine for the treatment of diabetes.

Chris Schott: Great. Thanks, very much just had a question on maritime and your plans in that phase II diabetes study company, obviously very excited about the broader opportunity for the drug but it does seem like diabetes as a more established market with maybe less of the capacity constraints that we've seen obesity. So can you just talk a little bit about what you think you need to see to be able to compete here and dislodge.

Speaker Change #109: Yeah, Thanks, Joe I would agree with you that.

Speaker Change #110: Differentiation that we've talked about for chronic weight management would hold in a robust way in type two diabetes and while there are lots of products that can control.

Speaker Change #110: Hyperglycemia and provided HVA once you control.

Speaker Change: <unk> Conference and can you also confirm this study is not needed to move forward in the phase III obesity studies and it's just completely separate program related to the diabetes piece of things. Thank you.

Speaker Change #111: There is a significant benefit if you can improve it.

Speaker Change #112: <unk> and persistence and we do believe that our monthly dosing could do that.

Chris Schott: We can take this in two pieces again. Jay, why don't you address the first piece, and then Murdo, feel free to jump in. Yes, absolutely.

Speaker Change #112: Our next question please julianne.

Speaker Change: Okay I'll take those two pieces again, Jay why don't you address the first piece and then Murdo feel free to jump in.

Julianne: Thank you Chris Our next question comes from creep up Deborah <unk> from <unk> Securities. Please go ahead. Your line is open.

Jay Olson: Yes, absolutely. As you have correctly identified, later this year we will initiate an additional dedicated Phase 2 study that will characterize Meritide for the treatment of diabetes in patients with and without obesity. And this new study is not a gating step at all for the Phase 3 program for patients with obesity but conforms to regulatory guidance and importantly allows us to optimize dosing for the diabetic patient, where medically, I can say, and Myrtle, I invite your considerable perspectives, I'm unaware of a highly efficacious monthly or less frequently administered medicine for the treatment of diabetes. Myrtle?

Jay: Yes, no absolutely.

Speaker Change: As you are nicely identified a later this year, we will initiate an additional dedicated phase II study that will characterize maritime for the treatment of diabetes in patients with and without obesity.

Deborah: Hey, guys. Thank you so much for taking my question.

Speaker Change #114: Other obesity question, but so I think Tien tsin.

Deborah: Yes.

Speaker Change #115: I'm not sure if you've talked about this before but does the conversation about.

Jay: This new study is not a gating step at all for the Phase III program for patients with obesity.

Martha: Martha preservation.

Speaker Change #116: People who are.

Speaker Change #118: We're losing weight on glad to have you.

Speaker Change: But conforms to regulatory guidance and importantly allows us to optimize dosing for the diabetic patient where medically I can say in Maryland.

Speaker Change #119: Evaluated this aspect with maritime either being the problem broadening the <unk> and <unk>.

Speaker Change #120: So where do you think maritime fits into that landscape. Thank you.

Speaker Change: Considerable perspective.

Speaker Change #120: Sure drew wants to jump in there sure no. Thank you for your question.

Im unaware of a highly efficacious monthly or less frequently administered medicine for the treatment of diabetes.

Speaker Change #121: As you apparently do as well are following this class.

Murdo Gordon: Yes, Jay. I would agree with you that the differentiation that we've talked about for chronic weight management would hold in a robust way for Type 2 diabetes. And while there are lots of products that can control hyperglycemia and provide HbA1c control, there is a significant benefit if you can improve adherence and persistence, and we do believe that our monthly dosing could do that.

Jeff: Yes, Thanks, Jeff.

Speaker Change: With you that.

Speaker Change #122: And that class of medicines that provoke remarkable weight loss for the impact on healthy tissues, including but not limited to muscle and the associated muscle loss that has been reported in the literature.

Speaker Change: Differentiation that we've talked about for chronic weight management would hold in a robust way in type two diabetes and while there are lots of products that can control.

Speaker Change: Hyperglycemia and provided HVA once you control.

Speaker Change #123: <unk> related Mechanistically. It may also relate to the quite dramatic cadence of weight loss of patients treated with these medicines and in the fullness of time, we and others will have that answer as you can imagine we're making many of these measurements on our own study and don't have any report any data to report to you here today, but we too are following this and all.

Speaker Change: There is a significant benefit if you can improve that.

<unk> and persistence and we do believe that our monthly dosing could do that.

Julien: Next question please Julien.

Kripa Devarakonda: Thank you, Chris. Our next question comes from Kripa Devarakonda from Truist Securities. Please go ahead. Your line is open.

Kripa Devarakonda: Next question, please, Julian. Thank you, Chris. Our next question comes from Kripa Devarakonda from Truist Securities. Please go ahead. Your line is open. Hey, guys. Thank you so much for taking my question. Another obesity question.

Julien: Thank you Chris Our next question comes from creep up Deborah <unk> from <unk> Securities. Please go ahead. Your line is open.

Speaker Change #122: Also the progress of some.

Hey, guys. Thank you so much for taking my question.

Speaker Change #122: Patients that are seeking to.

Deborah: Other obesity question, but slightly tangential.

Speaker Change #122: And the instrument sets to support muscle loss with obesity medicine.

Deborah: I'm not sure if you've talked about this before but there has been conversation about.

Speaker Change #128: That is quite interesting to us given our legacy of muscle biology, but I would say these are early insights from the field.

Speaker Change: Preservation and people who are.

Speaker Change #122: Knowledge, they have not proven has yet to be.

We're losing weight on glib.

Speaker Change #124: Debilitating to the patient, but we like you follow with interest.

Speaker Change: Youre evaluating this aspect with maritime do you see that being a problem broadening the case and.

Speaker Change #124: Julian thing, we're getting to the.

Speaker Change #124: Top after the hour here, maybe we'll just take two more questions.

Speaker Change: So where do you think maritime would fit into that landscape. Thank you.

Speaker Change #126: Certainly thank you keep up our next question comes from Jamie Shen from Deutsche Bank. Please go ahead. Your line is open.

Jay Olson: Sure. Jay, why don't you jump in there? Sure. No, thank you for your question. We, like you,

Speaker Change: Sure Jamie wants to jump in there sure no. Thank you for your question.

Jay Olson: Thank you for your question. We, as you apparently do as well, are following this class Bandaid class of medicines that provoke remarkable weight loss because of their impact on healthy tissues, including but not limited to muscle. And the associated muscle loss that has been reported in the literature may relate mechanistically and may also relate to the quite dramatic cadence of weight loss of patients treated with these medicines. And in the fullness of time, we and others will have that answer. As you can imagine, we're making many of these measurements in our own study and don't have any report, or any data to report to you here today.

As you apparently do as well are following this class.

Jamie Shen: Hi, guys. Thanks for taking my question.

Jamie Shen: The next obesity asset that entering clinic later this year can you specify whether this asset is aimed to fill in for 786 and.

And that class of medicines that provoke remarkable weight loss for the impact on healthy tissues, including but not limited to muscle and the associated muscle loss that has been reported in the literature.

Speaker Change #129: And whether there's no RBC asset will work in tandem with 133. Thank you.

Jamie Shen: Yes.

Speaker Change #130: Thanks, James we want to provide any further.

<unk> relate mechanistically. It may also relate to the quite dramatic cadence of weight loss Ah patients treated with these medicines and in the fullness of time, we and others will have that answer as you can imagine we're making many of these measurements on our own study and don't have any report any data to report to you here today, but we are following this and all.

Speaker Change #130: Insight into this medicine, it's just too early and as Bob shared this is nicely for patients a very competitive space.

Speaker Change #131: But as I shared earlier.

Speaker Change #130: <unk>.

Speaker Change #130: Deeper pipeline.

Speaker Change #130: And obesity, we remain interested in incretin pathways.

Jay Olson: But we too are following this and also the progress of some organizations that are seeking to administer medicines to support muscle loss with obesity medicine. That is quite interesting to us given our legacy of muscle biology. But I would say these are early insights from the field. To my knowledge, they have not proven yet to be debilitating to the patient.

Also the progress of some organizations that are seeking to.

Speaker Change #130: <unk> injectable, we're also pursuing oral medicines and so in the fullness of time, we'll have a chance to share more we're really playing the long game to drive.

Administer medicines to support muscle loss with obesity medicine that.

That is quite interesting to us given our legacy of muscle biology, but I would say these are early insights from the field.

Speaker Change #130: Differentiation benefit to the patient and to access segments of the market that are are not well address even by the current medicines.

<unk> knowledge, they have not proven is yet to be.

Speaker Change #130: And Julien, let's take our last question. Please.

Debilitating to the patient, but we like you follow with interest.

Kripa Devarakonda: But we like you to follow with interest. Julianne Singh, we're getting to the top half of the hour here, maybe we'll just take two more questions. Certainly. Thank you, Kripa. Our next question comes from...

Speaker Change #132: Thank you James our last question will come from Gary Nachman from Raymond James. Please go ahead. Your line is open.

Julianne thing, we're getting to the.

Speaker Change: Top after the hour here, maybe we'll just take two more questions.

Gary Nachman: Okay. Thanks, good afternoon, so shifting to <unk> when do you think we'll see more of an acceleration in the low <unk>.

Kripa Devarakonda: Certainly. Thank you, Kripa.

James Shin: Our next question comes from James Shin from Deutsche Bank. Please go ahead. Your line is open. Thank you for taking my question.

Certainly thank you keep up our next question comes from Jamie Shen from Deutsche Bank. Please go ahead. Your line is open.

Hi, guys. Thanks for taking my question.

Speaker Change #133: Patient <unk>.

Speaker Change #135: Reimbursable <unk> been improving for those patients.

The next obesity asset entering clinic later this year can you specify whether this asset is aimed to fill in for 786 and.

Speaker Change #135: Describe how much the Japanese opportunity could help next year.

Speaker Change #136: And then just talk about the overall resources, you're putting behind.

And whether there is no next obesity asset will work in tandem with 133. Thank you.

Speaker Change #135: Hi, <unk>.

Speaker Change #135: And the rest of the rare disease portfolio Thats, obviously, a much bigger focus for you now if that continues to ramp up at what pace and when you might get more operating leverage from that where everything business. Thank you.

Yes.

James Shin: Thanks, James. We won't today provide any further insight into this medicine. It's just too early.

Thanks, James we want today provide any further.

Speaker Change: Insight into this medicine, it's just too early and as Bob shared this is nicely for patients a very competitive space.

But a lot of questions that are very relevant every ticket in a couple of pieces go ahead of it.

But as I shared earlier.

Julien: <unk>.

Deeper pipeline.

Speaker Change #135: Yes so.

Speaker Change #135: So thanks for the question Gary.

And obesity, we remain interested in incretin pathways.

Speaker Change #135: We're pretty pleased with how we've been executing on as of this year and driving it towards growth.

<unk> injectable, we're also pursuing oral medicines and so in the fullness of time, we'll have a chance to share more we're really playing the long game to drive.

Speaker Change #135: As you rightly observed there are.

James Shin: And as Bob shared, this is, nicely for patients, a very competitive space. But as I shared earlier, in our deeper pipeline, in obesity, we remain interested in the incretin pathway, we remain interested in injectables, and we're also pursuing oral medicines. And so, in the fullness of time, we'll have a chance to share more. We're really playing the long game to drive a true differentiation benefit to the patient and to access segments of the market that are not well addressed even by the current medicine.

Speaker Change #135: A significant number of low caste patients or low clinical activity score patients that are suffering from this disease, who are not being appropriate accretive and specifically that's about 80000 out of the 100000 addressable patients in the U S. What we have been doing is seeing some.

Differentiation benefit to the patient and to access segments of the market that are are not well address even by the current medicines.

And Julien, let's take our last question. Please.

Gary Nachman: Thank you, James. Our last question will come from Gary Nachman from Raymond James. Please go ahead. Your line is open.

Thank you James our last question will come from Gary Nachman from Raymond James. Please go ahead. Your line is open.

Gary Nachman: Okay, thanks. Good afternoon.

Speaker Change #138: Amidst the momentum on expanding our prescriber base, which now in addition to Oculoplastic Surgeons also includes ophthalmologists and endocrinologists and this is a really important.

Okay. Thanks, good afternoon, so shifting to <unk> when do you think we'll see more of an acceleration in the low CF patients.

Reimbursement has been improving for those patients.

Speaker Change #135: Element here.

Describe how much the Japanese opportunity could help next year.

Speaker Change #135: <unk> focus on endocrinology is really important so that we can serve those.

And then just talk about the overall resources, you're putting behind <unk> and the rest of the rare disease portfolio.

Speaker Change #139: Patients with a low caste patients.

Speaker Change #135: Thank you.

Speaker Change #140: You asked about improving access.

Speaker Change #141: To date, we have achieved favorable medical policy changes for greater than 65% of U S covered lives and if you compare that to 50% last quarter and just over 5% above a year ago.

Obviously, a much bigger focus for you now.

That continues to ramp up at what pace and when you might get more operating leverage from that where everything business. Thank you.

But a lot of questions there, Gary but all of our ticket and a couple of pieces go ahead.

Speaker Change #141: I think we've made pretty good progress in enabling patient access using that base floor data that have become available last year.

Gary Nachman: So, shifting to Tepeza, when do you think we'll see more of an acceleration in the low CAF patients? And how has reimbursement been improving for those patients? And describe how much the Japanese opportunity could help next year. And then just talk about the overall resources you're putting behind TEPESA and the rest of the rare disease portfolio that's obviously a much bigger focus for you now, if that continues to ramp up, at what pace, and when you might get more operating leverage from that rare disease business.

Yes.

So thanks for the question Gary.

Gary Nachman: There are a lot of questions there, Gary, but why don't we take it in pieces? Go ahead, Vikram.

We're pretty pleased with how we've been executing on this year and driving it towards growth.

Speaker Change #141: We continue to see a significant growth opportunity, especially in the U S. While also recognizing that as we make.

Vikram Karnani: Yeah, so thanks for the question, Gary. Look, we're pretty pleased with how we've been executing on TEPASA this year and driving it towards growth. As you rightly observed, there is a significant number of low-cast patients or low-clinical activities for patients that are suffering from this disease who are not being appropriately treated, and specifically, that's about 80,000 out of the 100,000 addressable patients in the U.S. What we have been doing is seeing significant momentum in expanding our prescriber base, which now, in addition to oculoplastic surgeons, also includes ophthalmologists and endo And this is a really important element here.

As you rightly observed there are significant.

Speaker Change #141: Make progress with a lot of our execution efforts there continues to be.

Significant number of low caste patients so low clinical activities for patients that are suffering from this disease.

Speaker Change #141: <unk> between when we when we.

Who are not being appropriate accretive and specifically that's about 80000 out of the 100000 addressable patients in the U S. What we have been doing is.

Speaker Change #141: Knockdown values for access expand our prescriber base and.

Speaker Change #141: Ah patients get on therapy.

Speaker Change #141: And Japan, Gary we expect that.

Seeing significant momentum on expanding our prescriber base, which now in addition to Oculoplastic Surgeons also includes ophthalmologists and endocrinologists and this is a really important element.

There'll be an attractive market and so this would be well received.

Gary Nachman: In the country and we will talk about that once we've launched.

Gary Nachman: During the course of next year with respect to leverage I think I would just offer that we're on track with respect to our synergy targets, there and we'll begin to get even.

Element here.

Vikram Karnani: The strategic focus in endocrinology is really important so that we can serve those low-CAS patients, the low-cast patients, favorably. You asked about improving access. To date, we have achieved favorable medical policy changes for greater than 65% of US covered lives. And if you compare that to 50% last quarter and just over 5% about a year ago, I think we've made pretty good progress in enabling patient access using our phase four data that became available last year.

<unk> focus on endocrinology is really important so that we can serve those low CF.

Gary Nachman: Even more leverage as we were able to take full control of the supply chain for the rare disease products and then I would just further observe as we've said many times that we feel fortunate that there is a good overlap between some of our existing.

Patients with a low caste patients.

Favorably.

You asked about improving access.

To date, we have achieved favorable medical policy changes for greater than 65% of U S covered lives and if you compare that to 50% last quarter and just over 5% above a year ago.

Gary Nachman: <unk> capabilities in sales and marketing and the needs of those rare disease products. So all in all remain really excited about.

Gary Nachman: What we're able to do for rare disease patients the position, we have and the likelihood of just improving overtime.

We've made pretty good progress in enabling patient access using our base floor data data that was that had become available last year.

Gary Nachman: So with that let me just thank all of you know we've got a few minutes over.

Gary Nachman: But thank you all for participating in the call and we'll look forward to regrouping with you after the third quarter.

Vikram Karnani: So we continue to see a significant growth opportunity for Tepeza in the U.S., while also recognizing that as we make progress with a lot of our execution efforts, there continues to be a time lag between when we, you know, knock down barriers to access, expand our prescriber base, and see patients get on therapy. In Japan, Gary, we expect that there'll be, again, an attractive market and that this will be well-received in that country, and we'll talk about that once we've launched it there during the course of next year.

So we continue to see a significant growth opportunity to put together in the U S.

I'll also recognizing that as we make make.

<unk> progress with a lot of our execution efforts there continues to be a time lag between when we when we.

Knockdown values for access expand our prescriber base and see patients get on therapy.

And Japan, Gary we expected.

There'll be an attractive market and so this would be well received.

In that country, and we will talk about that once we have launched.

During the course of next year with respect to leverage I think I would just offer that we're on track with respect to our synergy targets, there and we will begin to get.

Vikram Karnani: With respect to leverage, I think I would just offer that we're on track with respect to our synergy targets there, and we'll begin to get even more leverage as we're able to take full control of the supply chain for the rare disease products. And then, as we've said many times, we feel fortunate that there is a good overlap between some of our existing capabilities in sales and marketing and the needs of those rare disease products.

Even more leverages, we're able to take full control of the supply chain for the rare disease products and then I would just further observe as we've said many times that we feel fortunate that there is a good overlap between some of our existing.

<unk> capabilities in sales and marketing and the needs of those rare disease products. So all in all remain really excited about.

Vikram Karnani: So all in all, I remain really excited about what we're able to do for rare disease patients, the position we have, and the likelihood of that just improving over time. So with that, let me thank all of you. I know we've gone a few minutes over the set time, but thank you all for participating in the call, and we'll look forward to regrouping with you after the third quarter. Thanks.

What we're able to do for rare disease patients the position, we have and the likelihood of just improving over time.

So with that let me just thank all of you know we've got a few minutes over.

But thank you all for participating in the call and we'll look forward to regrouping with you after the third quarter. Thanks.

Vikram Karnani: This concludes our 2024 Q2 earnings call. You may now disconnect.

This concludes our 2024 Q2 earnings call you may now disconnect.

Okay.

Yes.

Okay.

Yes.

Okay.

Sure.

Okay.

Yes.

Q2 2024 Amgen Inc Earnings Call

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