Q3 2024 Amgen Inc Earnings Call
Will address important unmet medical needs across a number of diseases, including type 2 diabetes.
Beyond obesity, we have momentum across each of our therapeutic areas, and I'll start with oncology.
In the third quarter, we saw strong in-market performance with 17% sales growth across the innovative oncology portfolio.
and several products experienced double-digit growth, including Ben Sito, which of course is our first by specific T-cell engagement or bite, which is now established as the standard of care and be cell acute lymphoblicyclic leukemia.
The launch of our next bite in Geltra is also progressing well with strong clinical conviction and three phase three studies underway in small cell lung cancer.
and further demonstrating the strength and promise of this platform in solid tumors, we're pleased to announce today that we will advance a value-in-a-rhythmic into phase three cycle development and advance prostate cancer in the fourth quarter.
Let me remind you to also keep an eye out for Phase 3 Bimmer, Tuzum App data and Gastric Cancer, which we should have in the next few months.
A rare disease portfolio delivered $1.2 billion as sales in the quarter, growing 21% year over year, driven by Tepesa, Restexa, Uplusina, and Tavneos.
These medicines are highly innovative, are still in the early stages of their life cycles and have significant upside potential, including expansion into new indications and geographies. For example, Tepeso was recently approved in Japan.
Also in rare disease, the Plosin-Ademistrated Compiling Data in Generalized Myisthenia Grabbas, and was granted breakthrough therapy designation in IGG-4 related diseases.
We're excited about the promise of an inaballismab in these settings and potentially another B cell mediated autoimmune diseases.
An inflammation to spire continued its strong trajectory with 67% growth year over year in the quarter.
We're further encouraged by the potential of test buyer in COPD and additional indications that we're also actively exploring.
And finally in general medicine, Repathana and Evinity are each delivering strong volume growth. Again, this quarter, these products are pivotal as we continue to serve more patients and meet the growing demand for therapies that address some of the most serious health challenges worldwide, like heart disease and osteoporosis.
Looking ahead, we remain confident that Amjaz Will positions to deliver long-term growth and innovation across each of our therapeutic areas. Our balanced portfolio combined with the strength of our pipeline, we think we'll continue to drive our business forward.
As always, I'd like to thank Michael Yee's cross-amage in for their unwavering commitment to patients and I want to now turn the call over to Murdo.
Murdo: Thanks Bob, execution was strong across our core therapy to Gary's and the third quarter, driving 24% year-over-year product sales growth. Each of our regions delivered double digit volume growth.
Murdo: and Sales of 10 products screwed by double-digit serbetter, including Repapa, Test Spire, Blincitel, Evinity, and Tapney Os, all brands that are important to our future growth trajectory.
Murdo: Starting with our General Medicine Portfolio, Sales of Rapaf and Evinity and probably a collectively group, 18% year over year in the third quarter, driven by volume growth.
We serve large patient populations with these therapies. For example, we expect Repatha and Proliya alone will help over 11 million patients in 2024.
Repass the sales increased 40% year over year to $567 million for the third quarter. Now annualizing at over $2 billion in sales.
Murdo: In the quarter we saw year over year volume growth of 41% and favorable changes to estimate as sales the doctions of 8% partially offset by lower net selling price of 10%.
Murdo: In the U.S. are expanded primary care, fuel force efforts drove a 50% year-over-year increase in primary care physician prescribers. U.S. volume growth was enabled by broad reimbursement and removal of prior authorization requirements by several pairs.
Outside the U.S. Repatha retains category leadership and continues to grow across major markets, despite increased competition in the segment.
If entity sales increased 30% year over year to almost $400 million for the third quarter.
and the U.S. event continues to be the segment leader with 61% of the bull and builder market.
Murdo: Strong U.S. volume growth was supported by an increase in prescription volume from both established and new eventy prescribers with a 34% quarter of a quarter increase in new provider accounts ordering eventy.
In Japan, a vanity continues to hold a leading position with 47% of the bone-builder segment, since launching in Japan in 2019, a vanity has been prescribed to approximately 600,000 patients.
The Vatetic Sales are now annualizing at approximately $1.5 billion.
Murdo: We're encouraged by the growth momentum we're driving and have conviction in the potential for eventity to help the many more women globally, who remain at risk of a fracture due to their post-menopausal osteoporosis.
Murdo: Prolius sales increased 6% year over year to $1 billion for the third quarter driven by 9% volume growth. In the US, we see broad prescribing base with more than 13,000 provider accounts using Prolius so far this year.
In inflammation, test buyer continues a strong trajectory with $269 million in sales in the third quarter. Sales increased 67% year over year supported by test buyers, uniquely differentiated profile and increased adoption by pulmonologists.
We're encouraged by the growth of test fire today and this potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma.
Murdo: Othazlo sales decreased 1% year over year for the third quarter with 5% volume growth. This volume growth was offset by 7% lower net selling price.
Murdo: Outsider Lerman is the only approved oral systemic therapy with a broad indication and is well positioned to help the more than 1.5 million systemic treatment naive U.S. patients with milder surreuses who cannot be optimally addressed by a topical treatment.
Enbro sales decreased 20% year over year for the Thark Quartha, primarily driven by 13% unfavorable changes to estimated sales deductions and 12% lower net selling price.
Murdo: Volumes grew 4% in the quarter. Going forward, we expect continued declining net selling price, relatively stable volume providing strong cash flow for our business.
Sales of our biosum or products increased 9% year over year in the third quarter. We have fully deployed our team in support of the recent U.S. launch of Pav Blue, a biosum or two Iliya.
Our teams move quickly to engage retin specialists and we're encouraged by the enthusiastic feedback from customers.
Our teams are also ready for the upcoming U.S. launches of Wezlanah, a biosimilar to Stilara and Beckenby, a biosimilar to Stilaris. Expect it in the first and second quarters of 2025, respectively.
Murdo: Overall, our biosomers portfolio continues to deliver attractive returns driven via a session business model.
You know, college sales of our seven innovative products, Blincytol, Luma Cras, Vectavix, Kyprolis, Endplay, Exjiva, and Indelta, grew 17% year over year for the third quarter, driven by volume growth and higher net selling price.
and Total These Products contributed over $2 billion of sales in the third quarter.
Murdo: [inaudible]
Growth was supported by the recent expansion of the Blincytal label, not approved by the US Food and Drug Administration for use in patients with Philadelphia, Chromosome, Negative B-cell, A-L-L in the consolidation phase regardless of measurable residual disease status.
Our U.S. launch of him Delta is progressing well, generating $36 million of sales in the third quarter. They're strong clinical conviction in both academic and community settings driven by him Delta's breakthrough efficacy.
We have a strong sense of urgency to bring in Delta to patients living with this aggressive disease.
Glumagrat sales increased 88% year over year to 98 million for the third quarter
Murdo: In fact, the big sales increased 12% year over year to $282 million for the third quarter, now annualizing at over $1 billion. And I call this group a percent year over year to $378 million in the quarter.
and Blake Sales increased 9% to $456 million for the third quarter. If we exclude government sales, and Blake Sales grew 18% year over year for the third quarter, driven by 14% volume growth and higher net selling price.
We've made significant progress in this quarter, driving execution and accelerating performance of our most important growth brands.
And with that, I'll turn it over to Vikram who'll cover our rare disease portfolio.
Vikram: Thank you, Murdo. I am pleased to provide an update on rare disease which delivered product sales of $1.2 billion in Q3.
Beginning with the Pazza for the treatment of Filer, I-D-Zs, third-water sales were $488 million, reflecting growth of 8% year over year, when compared to results from the legacy horizon business.
Vikram: Raffat, 100,000 TED patients in the US, and penetration is currently only in the single digits.
We are excited about the growth opportunity presented by the roughly 80% of T.E.D. patients who have a lower clinical activity score or cast.
As we have discussed previously, to more effectively reach these patients, we have recently reorganized and expanded our field force into two separate and dedicated teams.
One focused on comprehensive automologist and popular specialists and the other focus on endocrinologists.
Murdo: This approach reflects an optimized footprint to continue to serve patients with high cast disease while expanding our reach to those patients with low cast disease who can benefit from depesa.
We made this change in the third quarter and over the last few weeks, these teams have been actively focused on establishing new relationships with potential newspapers drivers.
We expect this optimized focus to gain traction over the next few quarters as physicians become more experienced identifying the right patients for treatment and navigating the reimbursement process to enable access to the peasant.
Following our 8% year over year growth this quarter, we remain confident in the long-term potential for the Pesa in the US as we expand our reach to patients with low cast disease and continue to work closely with payers to expand access.
International expansion remains a key growth opportunity with regulatory filings completed on in progress across multiple regions.
The Pazzo's approval in Japan in September marked a key milestone ahead of the launch, which is expected by early 2025.
Murdo: We also initiated a phase 3 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.
Faker for patients with chronic refractory gout, delivered $310 million in sales in Q3, representing 23% Yaron Werber, Urd, driven by volume growth from strong commercial execution
Chris Tessa with Immunomodulation has established a new standard of care for chronic refractory doubt.
Uplisna, for patients with neuromyelitis optic aspect from disorder or NMOSC delivered $116 million in failed in Q3, representing 58% year-over-year growth.
International Expansional Plasma is also underway with launches in multiple markets, including Canada which launched earlier this year.
Murdo: Additionally, we're excited by the growth potential of a place now driven by the striking data in both IGG-4 related disease which affects over 20,000 patients in the U.S.
Murdo: and Generalized Meistina Grabber's or GMG which affects nearly 80,000 to 100,000 patients in the U.S.
Sales of cab news were $80 million for the third quarter. Sales increased 116% year over year, driven by volume growth.
In the US, more than 4,300 patients with anchor associate vascularitis have been treated with tapios.
Murdo: Over 2600 healthcare professionals have now prescribed tab news, a roughly 53% increase in the prescriber base so far this year.
As we reflect on the past year, it's clear how far we've come in the integration and how well we're progressing.
I want to take this opportunity to express my sincere gratitude to all the team members that are working tirelessly to serve the needs of patient suffering from rare diseases.
Murdo: Looking ahead, we're excited about the opportunities and confident in what will achieve in our rare disease business and beyond.
Now, I'll hand it over to Jay for our R&D update.
Jay: Thank you, Vikram and good afternoon, everyone. In the third quarter, we made CNS progress advancing our broad clinical pipeline, which includes a number of potentially first in class or best in class therapies.
Since our last update, we have initiated a Phase 2 study of Maritide and take two diabetes and delivered positive, potentially practice changing Phase 3 data with a plesna in generalized my senior grovists.
Additionally, the FDA granted breakthrough therapy designation for a plasma and IGG-4 related diseases, so I'm just scoring the important potential impact of this medicine.
We also showcase promising data from several oncology programs and major medical conferences, including M. Delta, Zellaridomig, and AMG193 while reporting positive results from the first of eight phase three studies evaluating Rokatinlamab in A-Topic Dermatitis.
Jay: Let's begin with General Madison.
As previously mentioned, based upon the interim analysis of the ongoing phase-to-study of Maritide and chronic weight management, we are seeing a different sheet of profile and are confident. Maritide will address important, unmet medical needs and obesity, obesity-related conditions and take-see diabetes.
Jay: We remain on track and look forward to top line 52 week data from the Maritime 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 type II diabetes.
This quarter, we initiated a dedicated phase 2 trial investigating Maritime Patients with Type 2 diabetes, living with and without obesity. Maritime has a potential to be the first therapy in this setting with monthly or even less frequent dosing.
Beyond Maritime, our Phase I trial of AMG 513 is actively enrolling patients. We also continue to advance our preclinical obesity programs, which include both oral and injectable approaches, comprising both in cretin and non-increaten mechanisms.
Also a general medicine as a passer-in, but potentially best in class LP Littel A targeting small interfering R&A medicine. The fully enrolled phase 3 cardiovascular outcomes trial of a pass-rank continues to progress.
Jay: and oncology in Deltra, a first-in-class bicep specific T-cell engagement or bite molecule targeting DLL3 for small cell lung cancer. It's rapidly advancing into earlier lines of therapy with three phase-three studies underway in both extensive stage and limited stage disease.
Jay: To further enhance the patient experience, we are evaluating reduced monitoring protocols as part of the phase 3 program, and we have initiated a phase 1B study evaluating subcutaneous Tarlatumab in patients with second-liner later, extensive stage, small cell lung cancer.
In September, we presented impressive follow-up data from our Delphi 301 Phase II study of MDLTRA, in patients with extensive stage small cell lung cancer, demonstrating sustained anti-cancer activity and a manageable safety profile.
We also present the data from Delphi303, a Phase 1 Beast that he of him DelphiR combined with a PDL1 inhibitor as maintenance therapy, following four cycles of chemotherapy in first line extensive stage small saloon cancer.
This design is similar to our ongoing phase 3 study, Delphi-305, which tests the efficacy of Delphi-305, and Peter L1 inhibition versus Peter L1 inhibition alone. In first line, extensive stage, small cell uncancer, following platinum-based chemotherapy.
Jay: With the media in follow up of 10 months, Intelacher has demonstrated a manageable safety profile, media in duration of disease control of 9.3 months, media in progression free survival of 5.6 months, and a 9 month estimated overall survival of 89%.
Moving to our first-in-class, steep one, C-D-3 by specific molecule, Zaloretumig, we are pleased to announce that following consultation with regulatory authorities, we will initiate a phase three study in post-taxing, metastatic castrate, resistant prostate cancer, or MCRPC this quarter.
Jay: The promises that Alaret and Meg was recently evidenced by data presented in September. From a phase one dose exploration cohort, evaluating monotherapy in patients with MCRPC.
Jay: With the median follow-up of 27.9 months, the median overall survival was 17.7 months across all cohorts, a potential improvement upon the historical median survival of 12 to 15 months in the space population.
Additional data from a phase one randomized dose expansion in optimization cohort has identified the recommended dose and schedule for phase three clinical investigation.
Additionally, we are studying Zellore to make an earlier line of therapy, in combination and in earlier stages of prostate cancer.
Our Phase One study of Xelorid Omega in combination with Enceludimide in Aberadiron is ongoing. Recently, we have initiated two additional Phase One Beast Studies investigating Xelorid Omega in the upfront management of more localized disease.
The first study evaluates Neil Agevitt, Zellaridemik Therapy, that is prior to radical prostitectomy, and patients with newly diagnosed localized intermediate or high-risk prostate cancer.
The Second Study of Value 8's Value Rhythmic in High Risk, Non-Medicetic, Hormone sensitive prostate cancer after definitive therapy.
Jay: We are particularly excited about the potential of Zellarid Omega now are third by specific T-cell engagement, entering late stage clinical development.
Beyond our T-Telling Gators, we have completed an enrollment of 42102, a phase 3 study of Bermary II the Mab, our first in class, fiberblast growth factor receptor IIB directed monoclonal antibody, combined with chemotherapy and new volumab in first-line gastric cancer.
In the coming months we expect to read out the results of 4-2-101
A Phase 3 study of the Marituzumad combined with M. Fulfock 6 chemotherapy versus chemotherapy alone in first-line gastric cancer. This study was designed based on the successful Phase 2 fight study, which reported numerically longer progression-free survival and overall survival.
Lastly, we are also rapidly advancing AMG193, our oral PRM-C5 inhibitor developed for M-Tep Null Solid tumors.
We recently initiated a Phase 2 study of AMG193 in patients with M-Tappinol, previously treated advanced non-small cell lung cancer. This study will help to address regulatory agency requirements for dose optimization and selection.
In September, we presented encouraging data from a phase 1 dose escalation and initial dose expansion study, demonstrating promising amount of therapy activity and an acceptable safety profile.
Jay: Turning to information based upon encouraging phase 2 data from test buyer and patients with COPD, we are planning to initiate phase 3 studies in collaboration with AstraZeneca.
These trials will target patients with moderate to very severe COPD, with bloodiest sinful counts greater than or equal to 150 cells per microliter. We expect to begin enrollment in the first half of 2025.
Jay: Casparas also being investigated in separate phase three studies of patients with ESC in a philicosophageitis and in chronic bronchronicisitis with nasal polyps where top-line data are expected later this year.
In September, we announced positive results from the Phase 3 Horizon Study of Rokatinlamab in a topic sermon Titus.
Jay: The study medits co-primerian points and all key secondary end points.
We anticipate additional data readouts from the Rock of Program. We'll deepen our understanding of Roka Timlamad's profile.
Beyond A Topic Dermatitis, we continue to explore Rokatinlamab in moderate to severe asthma and perrogo-najilaris.
To expand the impact of our CD-19 directive therapeutics for even more patients suffering from serious inflammatory diseases, we have initiated Phase 2 studies of Blinitumamab, our CD-19 targeting bite molecule approved as Blincido.
and Nebelusumab, our CD19 targeting monoclonal antibody approved as a prisoner.
These studies build on mounting evidence of therapeutic benefit for B cell depletion and autoimmune diseases, from small, investigator-sponsored trials of Blinnatuma Mavin, systemic flerosis and refractory rumours for arthritis.
Our initial focus will be on systemic loop as aerosemiteosis with nephritis, with plans to expand into additional indications.
Jay: Shifting the rare disease, we recently presented potentially practice changing results from the phase 3 min study. The largest placebo controlled trial for a biologic therapy in generalized Myciniicrabis.
Mint, evaluated a prisoner in both a settle-colymer receptor auto antibody positive, ACHR positive, and muphal specific kinase auto antibody positive or musk positive populations.
Jay: At the reported 26-week-time point, a positive demonstrated clinically meaningful and statistically significant improvements in the My Senior Gravis activities of daily living score after just two doses compared to placebo.
This efficacy was observed in the combined ACHR and Musk positive populations, as well as in each population separately.
and also achieved statistically snifking improvements in the quantitative Myosemia Grabis score, compared to placebo at week 26 in the combined populations.
Jay: Importantly in the men's study, Patients in the Cork, the Sterides were tapered down starting a week four to a five-millimeter Dose by week 24.
Jay: Mint is the first and only phase 3 placebo controlled Mycini Gravis trial for a biologic that tapered corticostero use. As such, the efficacy observed with a plidna in patients with generalized Mycini Gravis offers a chance for meaningful benefit without the burden and toxicity of chronic steroid use.
We look forward to 52-week data for the ACHR Positive Co-Hort and Results from both ACHR positive and Musk-positive patient population. In the open-level period of the mince body, where a plesna has a potential to demonstrate durable efficacy.
Jay: Moving beyond general, I'd like to see you in the province in August the FDA granted a plesna breakthrough therapy designation for the treatment of immunoglobulin G4 related diseases, or IGQ4 related disease.
and the Facebook on data from the phase roomatology conference in November.
Jay: We are extremely encouraged by the potential of a prisoner in both my senior graphics and IGG-4-lated disease and are actively working to file these data with regulatory authorities.
In closing, I want to say my engine colleagues for their unwavering commitment to patients facing grievances for the focus, for the collaboration that's during this productive year. I'm now turning over to Peter for the financial update.
Thank you, Jay. We're pleased with our strong third-quarter performance in our on track with our 2024 full-year goals in long-term objectives.
Peter: We have a strong long-term growth outlook with breath and depths across each of our fourth therapeutic areas, including our innovative pipeline and in-market products, serving patients with serious illnesses around the globe.
We will continue to allocate capital to innovation first and with our strong cash flows, also intend to fund our other capital allocation priorities.
Starting with our third quarter results is shown on flight 28 of the flight deck, we delivered $8.5 billion in total revenue, a 23% year-over-year increase.
excluding the addition of horizon, products sales increase 8% year over year driven by 12% volume growth. In the US, our sales in the quarter were impacted by $173 million, an unfavorable change is to estimated sales deductions.
In the third quarter, we delivered a non-gap operating margin of 49.6%, as the percentage of product sales, with total non-gap operating expenses increasing 27%. You're overyear largely driven by the addition of horizon.
Non-Gap R&D spending in the third quarter increased 35% year over year to 1.4 billion. As we invested in the rapidly advancing late-stage pipeline, including Maritide, Bairou Routouza Matt, and Alpastaran, as well as Horizon Aquired Program.
Jay: Non-Gap SGNA expenses increase 21% year over year, primarily driven by the addition of horizon, excluding the addition of horizon, non-Gap SGNA expenses were relatively flat year over year.
Jay: The Verizon integration is progressing well, and we expect to reach $500 million in pre-tax costs synergies by year 3 post-acquisitions with more than 50% to be realized by the end of this year.
The acquisition is a creedive to non-gap APS year to date and we expect it to be for the full year as well.
Our non-gap OINE resulted in a 554 million expense.
Up 329 million year, almost entirely due to increased interest expense from the Horizon Acquisition. We continue to strengthen our balance sheet with $2.5 billion that's retired in the third quarter.
and expect to return to our pre-horizon acquisition capital structure by the end of 2025.
Jay: Our non-gap tax rate decrease 2.7% of the percentage points you're over here to 13.4% primarily due to the change in earnings mixed from the inclusion of arises.
and the third quarter of 2024, the company generated 3.3 billion of free cash flow and increased of $2.5 billion from the previous year.
Jay: Our strong cash flows enable investing in our business.
for long-term growth, including advancing our exciting pipeline opportunities and expanding capacity in our state of the Art Manufacturing Processes and Facilities.
Our past investments enable us to serve a significant number of patients today. For example, with over 43 million units expected for Repassah and Proliga alone in 2024.
On going in future investments will support Maritai and other products across the portfolio.
In addition, we return capital as shareholders as we pay competitive dividends of $2.25 per share in the second quarter. This represented a 6% increase compared to 2023.
But it's turned to the outlook for the business for 2024 on fly 30. We expect our 2024 total revenues in the range of 33.0 billion to 33.8 billion and non-gap, EPS between $19.25 to $20.
We do expect Q4, non-GAPEP has to be lower than Q3 non-GAPEP, yes, because of planned investment increases in our business, including key assets in our innovative pipeline, beginning with [inaudible]
This sequential pattern is consistent with historical trends
Let me mention a few considerations you modeled the remainder of 2024. We now project full year new assets sales at approximately $400 million, and other revenue at approximately $1.4 billion.
Jay: We expect the Pesaceals in Q4 to be flat, to slightly down versus the third quarter. Resulting in full year sales being roughly 5% year over year, as compared to the full year of the Pesaceals in 2023.
Jay: Consistent with prior years, we expect you for non-gap operating expenses to be the highest of the year and expect approximately 28% of our full year operating expenses to be in the fourth quarter.
This includes additional investments to drive momentum into 2025, for example in key brands like Ripata and Evanity.
Jay: For the full year, our total non-gap operating expenses are expected to grow approximately 25% year over year, including from the addition of Verizon.
We still expect full year non-gap R&D growth of more than 25% year over year
We now expect OI and A to be approximately 2.4 to 2.5 billion dollars, which includes the interest expense related to the $28 billion of debt rates for the Horizon Acquisition.
We now expect that non-gast pact rate to be in the 14-15% range, including the full-year benefits associated with the inclusion of the horizon business and favorable items in the quarter identified in the return to provision process.
Finally, our capital expenditure guidance remains at $1.3 billion for 2024. Our long-term growth outlook remains strong and ungrateful to our colleagues worldwide for their dedication to serve in patients.
Speaker Change: Thank you. If you'd like to ask a question, please press star, followed by one on your telephone keypad. If for any reason you would like to move that question, please press star, followed by one.
Again to ask the question, press their one.
Thanks for watching, you're doing well.
Jay: [inaudible]
Good afternoon. Thanks for taking my question. The Phase 2 Meriti data clearly remains the key update into year-end. Can you help us understand what you will share with regard to this update in terms of actual data and also the Phase 3 developmental plan and timelines and when we might get an update from the other obesity programs? Thank you.
Transcription by ESO, translation by — Transcription by —
Okay, it sounded like a few questions there, Salveen. As we said, we're continuing to be very excited about the prospects for Maritide, and we added the disclosure on this call that we have begun the Phase 2 study in Type 2 diabetes.
Jay: The conduct of the trial is continuing to progress well, and we're expecting to have the data here by the end of the year. And when we have those data, we'll obviously look forward to being able to share that with our investors.
Speaker Change: Julian, let's go to the next question please.
Thank you. Thank you. Thank you.
Speaker Change: Hi, good afternoon. Thank you for the question. You are getting a lot closer to kicking off a phase three Maritime program, so how do you think about the level of spend that will go into that kind of undertaking?
I mean, I assume we're looking at billions as it relates to investments just around R&D, but also manufacturing. But yeah, hoping you guys can put some numbers around it or at least better characterize how you're thinking about things from here. Also hoping you can clarify whether or not you have seen those Phase II data in-house.
Speaker Change: So, with respect to the Phase 3 trial, we would reiterate that we are expecting to pursue a broad Phase 3 trial in obesity, obesity-related conditions, and Type 2 diabetes.
Speaker Change: It will be, we would expect, a large global trial, fully exploring the molecule, and Jay, I'd invite you to add any color you'd like about the Phase 3 program, but obviously our investment in it will reflect our view that this is a differentiated molecule, and we look forward to having the full characterization of its safety and efficacy profile.
Yeah, thanks, Bob. We're fully on track, actively planning, expect to initiate a broad phase 3 program. This will include obesity.
obesity-related conditions, and type 2 diabetes, as you've heard already.
Speaker Change: We're progressing the Phase 2 study to characterize dose response, tolerability, efficacy in patients, importantly, without obesity but having Type 2 diabetes. So we're fully on track, actively planning the broad program.
And we'll, as part of our normal guidance process in the coming year, I'm sure we'll give an updated perspective then that reflects our plans for the Phase 3 trial, and then we'll also add any perspective that may be helpful on the capital expenditure front. I think what I just, you know, would remind you is that this molecule was designed on our existing antibody platform. It fits very well with our network as currently configured, and so, again, we'll have more to say about that through time as necessary.
And maybe to suggest, Bob, Olivia, it's Peter here. I would just remind you of Amgen's long history of being a leader in the science of manufacturing and process development.
That creates opportunities in terms of how we might view yield going forward. So while it might not just be bricks, mortar, and steel, yield is really important. We've got a really strong history in that.
And we did raise the CapEx guide this year, as you know, to about $1.3 billion. We're very thoughtful about that, and you also heard me mention that.
Research and development spanned up 35% quarter over quarter to the prior year. We expect it to be up over 25% for the year. So we certainly are investing where we always say we will in innovation, and Meritide's right at the front of that. And we look forward to investing to be a key player in this global public health crisis.
Speaker Change: Subs by www.zeoranger.co.uk
Julian, let's take the next question please.
Julian: Thank you, Olivia. Our next question comes from Michael Yee from Jefferies. Please go ahead, your line is open.
Speaker Change: [inaudible]
Michael Yee: Great, thanks so much. Maybe for Jay, it sounds like you guys are quite confident about Meritide, and yet you are also building a greater portfolio. I think you've announced 513.
And yet, you also don't have an oral. I don't believe so. Can you just comment about your philosophy or thinking about the totality of the portfolio, given 133 is so far in Phase 3, but the other things are so early, and whether you believe you have the portfolio today to be competitive with everybody else who has so many things late stage? Thank you.
Speaker Change: Thanks, Mike. I really appreciate the question.
With Meritide, we're really pleased with the execution of the study, await data later this year, fully focused, as I shared, on setting up the broad Phase III program.
Speaker Change: The development of additional medicines for obesity and obesity-related conditions is a source of really active investigation here preclinically and clinically now with 5.1.3, as you nicely mentioned. We've not as yet disclosed the mechanism of action of 5.1.3, which is a very interesting program, and as you note, and as is on clinicaltrials.gov,
Sad Mad Ascending Ghost Study has been announced, is enrolling, and features subcutaneous intravenous administration.
to reach, you know, the...
smaller segments, other segments within the obesity landscape to serve all the patients with obesity and its related conditions. We like many others are interested in both injectable as well as oral, non-injectable medicines. We're very interested in creatine pathway as well as non-creatine pathway mechanisms of action and our portfolio reflects each of these.
Speaker Change: Julianne, next question please.
Julianne: Thank you, Michael. Our next question comes from Courtney Breen from Bernstein. Please go ahead. Your line is open.
Thank you. Bye. Bye.
Thank you so much for the question today. Just anchoring on some of the conversation that you shared around the Horizon products and specifically for PESA.
Courtney Breen: Can you please provide some more context on the path to growth and when you expect to see the impact of the sales team there, particularly in the context of the final comments that were shared in terms of expectations for Q4 relative to Q3?
Let's take it in a couple of pieces. First, as you heard us say, the quarter grew 8%. Vikram, why don't you just remind our investors of the plan for expanding the sales force and then also perhaps speak to Japan, or international more general.
Yep, thanks, Bob. So as Bob just said, and as I said in my prepared remarks,
It's about to lose 8% year-over-year.
And as we have also said previously, we're continuing to focus on growth coming not only from the high-caste patients, but also the 80,000, roughly 80,000 patients that suffer from low-caste disease.
What we have learned over our time serving these patients and these prescribers is that in order to most effectively reach these low-cas patients, we need to have a dedicated effort towards both comprehensive ophthalmologists and ocular specialists.
well as endocrinologists. And what we have found is that type of coverage is necessary in order to serve the 80,000 or so low-caste disease patients that we have discussed previously.
This approach reflects an optimized footprint.
We believe that...
Speaker Change: Thank you.
Courtney Breen: This approach will allow us to not only help the right physicians and new prescribers find the right patients for Tepeza, but also help to enable access to Tepeza in the most appropriate way.
Courtney Breen: Finally, what I would say here is, you know, we, this is something that has, that has been, we've been working on for a little bit here, and this change occurred in the third quarter.
So, we do expect the momentum to play out here in the next several quarters. In the last few weeks, the teams have been actively focused on establishing new relationships with these new prescribers, and we look forward to updating you as we go.
Final point on the global aspects of TEPESA.
As you're aware, beyond the U.S., we're also looking forward to bringing to PESA
to patients around the globe, including Japan. Japan's a really important country for us in terms of our next launch. Let me remind you that we received approval in Japan for Tefeza with high-cast patients in September, and we're actively working to a early 2025 launch there as well.
Speaker Change: Julianne, next question please.
Thank you, Courtney. 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 had a two-part question on Maritide, if I may. Perhaps first, from a vomiting profile perspective, I recall in the Phase 1 trial, specifically in Phase 1, the vomiting profile was generally fairly consistent between low and high doses, which would imply perhaps titration in and of itself may not solve for vomiting.
But Jay, I'm curious, is there anything super important in the design of Phase 1 which wasn't incorporated that could have addressed that vomiting? That's number one. And then secondly, on the cadence of weight loss, is there any reason to expect
The plateau in weight loss did not happen past month seven or so, because we've seen other GLIPP trials kind of do that in six to seven months post-saturation. Thank you very much.
Yeah, thanks, Umer. I really appreciate it. You know, the Phase I study published now in January.
It's been pretty thoroughly considered.
Courtney Breen: This was a standard phase one dose escalation.
Courtney Breen: study that did not have antecedent dose titration. So if that answers your question, I suppose.
There's only so much that can be learned from the Phase I. We're honestly just really focused on these Phase II data, where at the interim we saw the differentiated profile, and as you know, we're in Phase III planning. Regarding weight loss plateau, this will be an interesting thing to observe and learn from the data, which we await later this year.
Speaker Change: All right, Julianne, next question, please.
Julianne: Thank you, Umer. Our next question comes from Jay Olson from Oppenheimer. Please go ahead, your line is open.
Jay Olson: Well, hey, congrats on the quarter, and thank you for taking the question. Maybe I'll shift gears to oncology. Congrats on all the progress and impressive growth, especially for Blincito. For sub-cube Blincito...
Jay Olson: It looks like the registrational study is now going to initiate in the second half of next year. Can you talk about what may have changed there and maybe share some color on the plans for that study? Thank you.
Thanks, Jay. This is Jay. The subcutaneous development of blintz cytosine is a major priority for us. We're very encouraged by the efficacy that we've seen with subcutaneous blintz cytosine in prior studies.
You'll remember perhaps that this medicine is dosed three times a week. We did a phase one study back in 2022 at Ashe with striking data among 21 valuable patients. We saw a 67% CR rate within one cycle.
There's been further data in the American Journal of Hematology since that time, 27 patients with an 85% CR rate, 75% of whom were MRD negative, and this is all without any grade 4 CRS.
So subcutaneous blind site was a major priority for us. It is progressing in clinical investigation, and there's really nothing to read into the timing that you allude to in your excellent question. Thank you.
All right, Julianne, next question, please.
Julianne: Thank you, Jay. Our next question comes from Terence Flynn from Morgan Stanley. Please go ahead, your line is open.
Hi, thanks for taking the question. Two-part on Maritide as well. Just wondering if you can confirm if the data disclosure will be a press release or it will be at a conference. I think the Phase 1 data were presented at the Insulin Resistance Conference in December. So just wondering the venue. And then for the Phase 3, Jay, do you think you're going to have to make any changes to the titration schedule you employed in Phase 2? I know Lily had extended their terzapatide titration schedule when they moved from Phase 2 to Phase 3. Do you think that's something that could be necessary here? Thank you.
In terms of the release, Terence, and how we share that with investors, again, we're focused on getting the data in hand, and when we have them, we'll try to do whatever's in best interest of the shareholders.
Stay tuned. As soon as we have them, we'll look forward to being able to report those.
And, Jay, do you want to address the question on Phase 3? You know, the Phase 3 planning, as we've shared, is fully on track, and we won't today give any news or insight into our approach to dosing, but we feel confident it'll be well-informed by the Phase 2 study that is ongoing, and we'll read out later this year.
Great. Next question, please, Julian.
Julian: Thank you, Terence. Our next question comes from Carter Gould from Barclays. Please go ahead. Your line is open.
All right, good afternoon. Thanks for taking the question. I want to maybe switch it up a little bit and ask you around the PAV Blue launch, you know, Amgen's biosimilars have, some have gone really well, others a little bit less so. You've historically talked about the importance of being first.
But, how do you think about adoption ahead of a Q code and discussions with any payers, your expectation around step edits for biosimilars ahead of some of the other newer entrants? Thank you.
Yeah, thanks, Carter. Murdo, why don't you share your thoughts in general on the biosimilar franchise. We don't often get a chance to talk about it, but please, also on Pad Blue.
Murdo: Thanks, Bob. We're obviously quite excited about...
The next wave of launches, not just Pav Blue, but our other biosimilar launches that we are expecting in the not-too-distant future, as I mentioned in my opening remarks.
Julianne: with Wieslana and Bekembe.
On Pablo, as you mentioned, Carter, it's important to be first or in the first wave.
Clearly, we're in that position now as we're launching this product as we speak.
And we expect there to be strong interest in Pad Blue.
pretty much early on in the launch phase. Obviously, having permanent Q codes in this case, given that it's about as similar, are important, but there's a lot of interest out there, even as we may have a temporary reimbursement code.
And generally, Carter, as you know, we've built what we think is an industry leading biosimilar franchise. It's a franchise that is performing very well, and we think it's earning attractive returns for our shareholders.
Speaker Change: Next question, please.
Thank you, Carter. Our next question comes from Chris Schott from J.P. Morgan. Please go ahead. Your line is open.
Great. Thanks so much. Can I ask a quick question on Tez Spire in COPD? Obviously, some really nice Phase 2 data earlier this year, but just I was interested in how you think about the potential landscape here as we consider both DUPIX and essentially the IL33s coming to market ahead of you. It seems like you might have a broader program and some interesting data, but just tell me a little bit about how you're just commercially seeing that fitting into the landscape. Thank you.
Thank you. Thank you. Thank you.
Well, Chris, why don't I start, and this is Jay, and Murdo, hand off to you. So, TEDSPR, as all here know, is our TSLP monoclonal antibody that we're developing with AstraZeneca.
And recently, we had a chance to read out a very compelling Phase II study in moderate to very severe COPD. This was a 337-patient study.
Julianne: these patients were having exacerbations despite triple therapy, and we went head-to-head against placebo over a 52-week period of time, a population actually broader even than DUPI, and Murdo, I perhaps invite you to reflect on that.
The data were quite positive, with a numerically reduced exacerbation rate by 17%. We learned a lot from biomarker studies of bloody eosinophils as to which subsets of patients all preplanned stand to benefit the most.
And with these learnings, we're now pleased to announce that we're planning to initiate Phase III studies together with AstraZeneca.
Julianne: This trial is well-structured and set up to definitively answer the question around efficacy of Tespire.
And Murdo, would you like to reflect a little bit about our competitive posture? Yeah, thanks for the question, Chris. We're obviously really pleased with the performance of TestSpire so far in severe uncontrolled asthma. We're actually now the second...
most prescribed product when it comes to new to brand prescriptions in that category. So I think it's clear now that allergists and pulmonologists appreciate the differentiated profile and the unique mechanism of action that is test buyer.
that ability to address a broader population of patients because of the unique mechanism of action and the upstream way in which it intervenes in the immune inflammation cascade. We are we're hopeful that that differentiation and will continue to play out in COPD and we feel really good about the opportunity to compete there with the combined resources of our partners at AstraZeneca and Amgen. We have a very strong share of voice currently in severe and uncontrolled asthma and we expect to be able to affect that same strong share of voice on the on the successful completion of the phase 3 trial.
All right, Julian, let's take the next question, please.
Chris, our next question comes from Evan Seigerman from BMO Capital Markets. Please go ahead. Your line is open.
Hi, guys. Thank you so much for taking my question. I want to touch on the Biosimilar launch for the Equivalence of Biosimilar. Maybe talk about some of the launch strategy and, more specifically, how you can stimulate demand among ophthalmologists who would otherwise choose a branded product. Are you able to offer rebates or extended invoicing for these practices? Thank you so much.
Julianne: Thank you. Thank you.
Speaker Change: Thanks for the question. Obviously, I'm not going to talk about what we're doing commercially with respect to contracting.
I will just say that we have a very broad deployed field force covering the key customers in this therapeutic area. We have a very strong institutional organization that covers the purchasing groups and the large networks that treat a large percentage of the populations here and the receptivity has been high.
This isn't our first biosimilar launch and we've been preparing effectively and we're excited to be in the market.
Julianne, next question please.
Thank you, Evan. 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, and congrats on the quarter. Maybe a question for Jay. Given that you have diabetes patients with obesity in the ongoing Phase 2 trial, do you think you would be able to look into the A1C profile of the drug as well, or is it just too small a trial to make any conclusion about that at this point?
Yeah, thank you, Mohit. As you know,
Type 2 diabetes runs, regrettably, with obesity and with overweight, and so we do hope and expect to have some insights into diabetic, anti-diabetic activity from the Phase 2 study. But we need to have an experience in the dedicated Phase 2 study of diabetes, in particular in patients without obesity. So more to follow there towards later this year.
Speaker Change: Next question please, Julian.
Thank you, Mohit. Our next question comes from Yaron Werber from TD Cowen. Please go ahead, your line is open.
Great, Murdo, I got maybe a couple of questions for you. One just on Enbro, this quarter we didn't see the normal Q3 bounce back.
Speaker Change: And then secondly, you mentioned 12,000.
accounts of 13,000 accounts ordering Prolia I presume you're mentioning that on purpose is relating to the upcoming biosimilar launches you know late May next year can you talk about maybe just that that dynamic and Prolia versus Xtriva what to expect next year thank you
Thanks for the questions, Yaron. Yes, as you picked up, Enbrel was impacted by two negative trends in the quarter. One, of course, the regular decline in net price, and then another one which was a 30% adjustment in the quarter. So the quarter is a little softer than you normally see. Volume was up 4% in the quarter, so Enbrel continues to do quite well in terms
Speaker Change: prescribers treating patients.
But we are expecting continued...
Net price declines going forward
Speaker Change: When we look at Prolia, I mentioned that we have 13,000 provider accounts having treated patients with Prolia so far this year. This is just to give an idea of the breadth and utility of this important product. The other thing that we enjoy with Prolia is it's an important way for us to source potential patients.
for Ivenity, which we continue to see very strong growth in.
We feel really good about it, and yes, it could end up becoming something that helps us in terms of market presence in the face of biosimilar competition in the future.
Speaker Change: All right, Julianne, let's take the next question, please.
Julianne: Thank you, Yaron. Our next question comes from Gregory Renza from RBC Capital Market. Please go ahead, your line is open.
Great, good afternoon and thanks for taking my question. Bob, maybe just looking at the rare disease franchise and we've always mentioned, you've mentioned that it's certainly a different approach in this space. And to that, what is Amgen's approach on pipeline replenishment when it comes to the rare disease pillar?
Discontinuation in IPF. Just curious how to think about specific
Speaker Change: disease areas in rare disease and also how...
Speaker Change: how you think about kind of supporting and following your current marketed products in the rare disease.
Speaker Change: Youth Franchises.
Speaker Change: Thanks so much. Yeah. We can take this in a couple pieces. And we're obviously very excited about rare disease and what we think we can bring to the field.
with respect to the molecules that are already on the market. Each of them, as you know, is in an early stage of this life cycle.
either diseases or molecular attributes that we think we can add a lot of value to over time.
Speaker Change: We're excited about what we think we can do with those domestically and in international markets. And we're also excited about, frankly, how our genetics resource, which you're familiar
has enabled us to glean insights both from existing...
molecules in the rare disease portfolio as well as potentially others that we might be able to add to it. But I'd invite Jay to share his thoughts as he's already brought a lot of energy to this.
with our rare disease organizations. So, Jay, fire away. Thanks, Bob, and thanks, Gregory, for the question. The acquisition of Horizon has really activated and energized our staff in R&D.
I think inspired by the mechanistic repositioning of a tepeza for thyroid eye disease.
Speaker Change: The capacity to bring rare disease medicine expertly to patients around the world has really activated the imagination of our R&D colleagues and we've had multiple new project launches since the acquisition of Horizon.
Second, I would say that the integration has gone very smoothly and the staff who've joined us through the Horizon Acquisition have both seamlessly executed the development priorities for the rare disease portfolio and also have brought a lot of really interesting ideas.
We have now a rare disease initiative with dedicated leadership. We have dedicated leadership in rare disease drug development, and we hope and expect to continue just the best-in-class external innovation that Horizon was really known for in this space.
So, a blend of internal and external innovation will, I think, more than replenish the rare disease mid- and early-stage pipeline in the years to come. We're also very excited about the talent that joined us from Horizon, particularly on the research and the medical side, so we feel really well-equipped now to...
Speaker Change: continue to invest in this area and make a difference for patients.
So, Julie and Singh, as we're getting to the half hour here, maybe we'll take two more questions.
Certainly. Thank you Gregory. Our next question comes from Matt Phipps from William Blair. Please go ahead, your line is open.
Good afternoon. Thanks for taking my question. Just wanted to confirm if the 420 mg dose is what's going to be taken forward into the COPD trials, and is that something that you can formulate into a single injection given it's twice, I believe, the current?
Speaker Change: size. And then this, just to confirm, this is two separate phase three trials. Will they be identical in design? Thank you.
Speaker Change: Yeah, Matt, thanks for the question. They're good questions, but none that we can address here today. Together with our colleagues from AstraZeneca, we'll have a chance to describe in full the design of the Phase 3 program that will support the consideration of test-bio and COPD soon to come.
All right, Julian, I think we have time for one more.
Our last question today will come from Chris Raymond from Piper Sandler. Please go ahead, your line is open.
Hey, thanks for squeezing me in. Just back on Pav Blue, we've gotten some interesting doc feedback on this with a decent amount of receptivity to this option.
And one thing that's kind of a new development, I think, at least in the U.S. market, has been a recent supply disruption to Avastin, which may actually provide maybe more of an opening for this launch. I'm just curious, as you looked at the market,
Talk about how you looked at the role of biosimilars in this predominantly buy-and-bill market with a very inexpensive option in Avastin.
but one that seems to be fading at least in terms of suppliers wanting to provide the drug. I guess bottom line, does this Avast and supply issue make this even more interesting to you guys? Thanks.
Thanks for the question Chris, but first and foremost obviously when you're treating
Speaker Change: Thank you.
serious illness, you want to have, as a provider,
and your staff get used to handling, and I can say.
We are very fortunate to have world-class manufacturing.
here at Amgen, and we continue to have a highly reliable...
supply chain and manufacturing capability. We have benefited from shortages with other biosimilars.
including Avastin, and as I'll remind you, we have Envasi, our own biosimilar to that product.
So we are seeing customers coming to us given some shortages here in the U.S. and around the world and you know again I'm thankful for our manufacturing colleagues here at Amgen who are putting us in a very strong position to be able to speak to institutional customers to individual providers and obviously communicate with patients about the ability for us to supply and the reliability of that over time.
That being said, I think, you know, we're definitely looking at our own opportunity here in the market with tab blue. I think you mentioned that there's high interest in the customers that you've talked to. These retina specialists are sophisticated customers. They understand.
that if they're going to go with a manufacturer, they're gonna want a relationship that is persistent over time. And we believe we're well positioned for that.
We have a great device in a pre-filled syringe. We also have vials. So we're able to supply this demand in this market. And that's what we intend to do. And that's what our teams are in the field establishing right now. But thanks for your interest.
Okay, Julian, thanks for moderating our call, and thank you all for joining us. If there were any of you who didn't get a chance to ask your questions, Justin and his team will be around still for a few more hours. So we look forward to gathering with you when we next have relevant information. Thank you very much.
Speaker Change: Bye-bye.
Speaker Change: This concludes our 2024 Q3 Earnings Call. You may now disconnect.