Q2 2026 Rigel Pharmaceuticals Inc Earnings Call

Speaker #1: Good evenings, and welcome to the Rigel Pharmaceuticals Financial Conference call for the second quarter of 2026. At this time, all participants are on a listen-only mode.

Operator 2: Greetings, welcome to the Rigel Pharmaceuticals Financial Conference Call for Q2 2026. At this time, all participants are on a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Furey. You may begin.

Operator: Greetings, welcome to the Rigel Pharmaceuticals Financial Conference Call for Q2 2026. At this time, all participants are on a listen-only mode. A brief question-and-answer session will follow the formal presentation.

Speaker #1: A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Operator: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Furey. You may begin.

Speaker #1: As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel, and Corporate Secretary.

Speaker #1: Thank you, Mr. Furey. You may begin.

Speaker #2: Welcome to our second quarter 2026 financial results and business update conference call. The financial press release for the second quarter of 2026 was issued earlier today and can be viewed, along with the slides for this presentation, in the News and Events section of our Investor Relations site on rigel.com.

Ray J. Furey: Welcome to our Q2 2026 Financial Results, a Business Update Conference Call. The financial press release for the Q2 2026 was issued earlier today and can be viewed along with the slides for this presentation in the news events section of our investor relations site on Rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for commercial, regulatory, product development, and other business activities. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. Description of those risks can be found in our most recent annual report on Form 10-K for the year ended 31 December 2025, on file with the SEC, and subsequent filings with the SEC, including our Q2 quarterly report on Form 10-Q with the SEC.

Ray Furey: Welcome to our Q2 2026 Financial Results, a Business Update Conference Call. The financial press release for the Q2 2026 was issued earlier today and can be viewed along with the slides for this presentation in the news events section of our investor relations site on Rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for commercial, regulatory, product development, and other business activities.

Speaker #2: As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for commercial, regulatory, product development, and other business activities.

Speaker #2: These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. Description of those risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2025, on file with the SEC and subsequent filings with the SEC, including our Q2 quarterly report on Form 10-Q with the SEC.

Ray Furey: These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. Description of those risks can be found in our most recent annual report on Form 10-K for the year ended 31 December 2025, on file with the SEC, and subsequent filings with the SEC, including our Q2 quarterly report on Form 10-Q with the SEC.

Speaker #2: Any forward-looking statements are made only as of today's date. And we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances, except as required by law.

Ray J. Furey: Any forward-looking statements are made only as of today's date. We undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances, except as required by law. At this time, I would like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Raul?

Ray Furey: Any forward-looking statements are made only as of today's date. We undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances, except as required by law. At this time, I would like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Raul?

Speaker #2: At this time, I would like to turn the call over to our president and chief executive officer, Raul Rodriguez. Raul, thank you.

Raul R. Rodriguez: Thank you, Ray. Thank you all for joining us today. Also with me today are Dave Santos, our Chief Commercial Officer, and Dean Schorno, our Chief Financial Officer. I would also like to welcome Dr. Alison Hannah, our newly appointed Chief Medical Officer, who is with us today and will discuss our development pipeline. To begin, I will provide an overview of Rigel's business, our accomplishments for the Q2, and the strategic initiatives that positions us for continued growth in the coming years. Moving to slide four. The Q2 was an excellent one and marked an important step in Rigel's transformation into a diversified commercial oncology and hematology company. During the quarter, we continued to grow our current products. We completed the in-license of VEPPANU or vepdegestrant, adding a significant near-term growth driver.

Raul Rodriguez: Thank you, Ray. Thank you all for joining us today. Also with me today are Dave Santos, our Chief Commercial Officer, and Dean Schorno, our Chief Financial Officer. I would also like to welcome Dr. Alison Hannah, our newly appointed Chief Medical Officer, who is with us today and will discuss our development pipeline. To begin, I will provide an overview of Rigel's business, our accomplishments for the Q2, and the strategic initiatives that positions us for continued growth in the coming years. Moving to slide four. The Q2 was an excellent one and marked an important step in Rigel's transformation into a diversified commercial oncology and hematology company. During the quarter, we continued to grow our current products. We completed the in-license of VEPPANU or vepdegestrant, adding a significant near-term growth driver.

Speaker #3: today. Also with me today are Dave Santos, our chief commercial officer, and Dean Schorno, our chief financial officer. I would also like to welcome Dr. Allison Hano, our newly appointed chief medical officer, who is with us today and will discuss our development pipeline.

Speaker #3: To begin, I will provide an overview of Rigel's business, our accomplishments for the second quarter, and the strategic initiatives that position us for continued growth in the coming years.

Speaker #3: Moving to Ray. slide 4, the second quarter was an excellent one. It And thank you all for joining us marked an important step in Rigel's transformation into a diversified, commercial oncology and hematology company.

Speaker #3: During the quarter, we continued to grow our current products, we completed the in-license of Bepanu, or Beptagestrin, adding a significant near-term growth driver, we delivered another quarter of strong profits, and we continued advancing our 289 in lower-risk MDS in our dose expansion trial, with a readout at year-end.

Raul R. Rodriguez: We delivered another quarter of strong profits. We continued advancing R289 in lower risk MDS in our dose expansion trial with a readout at year-end. We believe these actions positions Rigel for sustainable near-term and long-term growth. On the slide, you see the strategic framework that has guided Rigel's transformation and will continue to drive our growth. Our strategy is centered on four core strategic objectives: grow our commercial business, expand our product portfolio and pipeline through in-licensing or acquisition, advance our development pipeline in the clinic, and maintain financial discipline. Together, these four pillars support a durable long-term growth strategy. Our May announcement of the exclusive global license of VEPPANU demonstrates our execution of this strategy. It expands our portfolio with an important new commercial opportunity and furthers our long-term growth trajectory. Moving to slide five.

Raul Rodriguez: We delivered another quarter of strong profits. We continued advancing R289 in lower risk MDS in our dose expansion trial with a readout at year-end. We believe these actions positions Rigel for sustainable near-term and long-term growth. On the slide, you see the strategic framework that has guided Rigel's transformation and will continue to drive our growth. Our strategy is centered on four core strategic objectives: grow our commercial business, expand our product portfolio and pipeline through in-licensing or acquisition, advance our development pipeline in the clinic, and maintain financial discipline. Together, these four pillars support a durable long-term growth strategy. Our May announcement of the exclusive global license of VEPPANU demonstrates our execution of this strategy. It expands our portfolio with an important new commercial opportunity and furthers our long-term growth trajectory. Moving to slide five.

Speaker #3: We believe these actions position Rigel for sustainable near-term and long-term growth. On the slide, you see the strategic framework that has guided Rigel's transformation and will continue to drive our growth.

Speaker #3: Our strategy is centered on four core strategic objectives: grow our commercial business, expand our product portfolio and pipeline through in-licensing or acquisition, advance our development pipeline in the clinic, and maintain financial discipline.

Speaker #3: Together, these four pillars support a durable, long-term growth strategy. Our main announcement of the exclusive global license of Bepanu demonstrates our execution of this strategy.

Speaker #3: It expands our portfolio with an important new commercial opportunity and furthers our long-term growth trajectory. Moving to slide 5, Bepanu significantly expands Rigel's commercial oncology platform into breast cancer and provides the opportunity to leverage our commercial capabilities across this substantially larger market.

Raul R. Rodriguez: VEPPANU significantly expands Rigel's commercial oncology platform into breast cancer and provides the opportunity to leverage our commercial capabilities across this very substantially larger market. VEPPANU is the first and only FDA-approved proteolysis targeting chimera, or PROTAC, for the patients with second-line or later ER-positive, HER2-negative, advanced or metastatic breast cancer with an ESR1 mutation. There's a critical unmet need in this patient population, and we believe VEPPANU is an important new treatment option. With a novel mechanism and differentiated data, we believe VEPPANU has potential to become a market-leading treatment. When the transaction was closed in June, our team across the organization began actively preparing for the commercial launch, and we are on track for VEPPANU to be available in mid-August. Dave and Alison will provide more information on our launch preparations and the clinical data supporting the FDA approval. Moving to slide six.

Raul Rodriguez: VEPPANU significantly expands Rigel's commercial oncology platform into breast cancer and provides the opportunity to leverage our commercial capabilities across this very substantially larger market. VEPPANU is the first and only FDA-approved proteolysis targeting chimera, or PROTAC, for the patients with second-line or later ER-positive, HER2-negative, advanced or metastatic breast cancer with an ESR1 mutation. There's a critical unmet need in this patient population, and we believe VEPPANU is an important new treatment option. With a novel mechanism and differentiated data, we believe VEPPANU has potential to become a market-leading treatment. When the transaction was closed in June, our team across the organization began actively preparing for the commercial launch, and we are on track for VEPPANU to be available in mid-August. Dave and Alison will provide more information on our launch preparations and the clinical data supporting the FDA approval. Moving to slide six.

Speaker #3: Bepanu is the first and only FDA-approved proteolysis-targeting chimera, or PROTAC, for the patients with second-line or later ER-positive HER2-negative advanced or metastatic breast cancer with an ESR1 mutation.

Speaker #3: There is a critical unmet need in this patient population. And we believe Bepanu is an important new treatment option. With the novel mechanism and differentiated data, we believe Bepanu has potential to become a market-leading treatment.

Speaker #3: When the transaction was closed in June, our team across the organization began actively preparing for the commercial launch, and we are on track for Bepanu to be available in mid-August.

Speaker #3: Dave and Allison will provide more information on our launch preparations and the clinical data supporting the FDA approval. Moving to slide 6: Since 2020, we have transformed Rigel from a single-product company with a limited development pipeline and significant cash burn into the profitable, multi-product company with a promising pipeline that we are today.

Raul R. Rodriguez: Since 2020, we have transformed Rigel from a single-product company with a limited development pipeline and significant cash burn into the profitable multi-product company with a promising pipeline that we are today. In 2026, we expect to grow a compound annual growth rate of approximately 35% since 2022 using the midpoint of our 2026 net product sales guidance, which excludes any contribution from VEPPANU. We view this performance as a foundation of our next phase of growth. Our in-license of VEPPANU marks the next major step in Rigel's evolution. We believe it has potential to become Rigel's largest commercial product and meaningfully drive growth through the end of the decade and beyond. Looking towards the 2030s, we plan to build on the momentum of our commercial portfolio.

Raul Rodriguez: Since 2020, we have transformed Rigel from a single-product company with a limited development pipeline and significant cash burn into the profitable multi-product company with a promising pipeline that we are today. In 2026, we expect to grow a compound annual growth rate of approximately 35% since 2022 using the midpoint of our 2026 net product sales guidance, which excludes any contribution from VEPPANU. We view this performance as a foundation of our next phase of growth. Our in-license of VEPPANU marks the next major step in Rigel's evolution. We believe it has potential to become Rigel's largest commercial product and meaningfully drive growth through the end of the decade and beyond. Looking towards the 2030s, we plan to build on the momentum of our commercial portfolio.

Speaker #3: In 2026, we expect it to grow we expect to grow a compound annual growth rate of approximately 35% since 2022, using the midpoint of our 2026 net product sales guidance, which excludes any contribution from Bepanu.

Speaker #3: This view is we view this performance as a foundation of our next growth phase, phase of growth. Our in-license of Bepanu marks the next major step in Rigel's evolution.

Speaker #3: become Rigel's largest commercial product and meaningfully drive growth through the end of the decade and beyond. Looking toward the 2030s, we plan to build on the momentum of our commercial portfolio.

Speaker #3: We will also continue to evaluate late-stage in-licensing or acquisition opportunities that address areas of significant need, offer substantial growth potential, and continue to further expand our We believe it has potential to portfolio.

Raul R. Rodriguez: We will also continue to evaluate late-stage in-licensing or acquisition opportunities that address areas of significant need, offer substantial growth potential, and continue to further expand our portfolio. Subject to positive clinical data and regulatory approval, R289 could become a new treatment option for patients with lower risk MDS and potentially other indications. Several of the possible R289 indications represent potentially billion-dollar market opportunities. If successful, this could significantly expand our commercial portfolio in the 2030s and beyond. Together, these opportunities can drive sustained growth and long-term shareholder creation, with the potential to transform Rigel once again. With that, I will turn the call over to Dave to discuss our commercial business and VEPPANU and our progress towards commercial availability. Dave?

Raul Rodriguez: We will also continue to evaluate late-stage in-licensing or acquisition opportunities that address areas of significant need, offer substantial growth potential, and continue to further expand our portfolio. Subject to positive clinical data and regulatory approval, R289 could become a new treatment option for patients with lower risk MDS and potentially other indications. Several of the possible R289 indications represent potentially billion-dollar market opportunities. If successful, this could significantly expand our commercial portfolio in the 2030s and beyond. Together, these opportunities can drive sustained growth and long-term shareholder creation, with the potential to transform Rigel once again. With that, I will turn the call over to Dave to discuss our commercial business and VEPPANU and our progress towards commercial availability. Dave?

Speaker #3: The subject and subject to positive clinical data and regulatory approval are 289 could become a new treatment option for patients with lower-risk MDS and potentially other indications.

Speaker #3: Several of the possible R289 indications represent potentially billion-dollar market opportunities. If successful, this could significantly expand our commercial portfolio in the 2030s and beyond.

Speaker #3: Together, these opportunities can drive sustained growth and long-term shareholder creation. With the potential to transform Rigel once again, with that, I will turn the call over to Dave to discuss our commercial business and Bepanu and our progress towards commercial availability.

Speaker #3: Dave?

Speaker #2: Thank you, Raul. On slide 8, you'll see our three commercial products: Tobilies, Gevreto, and Reslidia. Moving to slide 9, which shows our product revenue for the second quarter of 2026.

David A. Santos: Thank you, Raul. On slide eight, you'll see our three commercial products, TAVALISSE, GAVRETO, and REZLIDHIA. Moving to slide nine, which shows our product revenue for Q2 2026. We generated $67 million in US net product sales, an increase of $8.1 million over Q2 2025, representing a 14% increase year-over-year. For TAVALISSE, we reported another strong quarter in which we generated a record $47.4 million in net product sales, an increase of 18% compared to Q2 2025, which was aided by favorable gross to net and inventory dynamics. TAVALISSE was launched in 2018, and we're pleased to see continued contribution from this mature product. For GAVRETO, we delivered $10.7 million in net product sales, a decrease of 10% compared to Q2 2025. GAVRETO continues to be a stable, contributing product in our portfolio.

Dave Santos: Thank you, Raul. On slide eight, you'll see our three commercial products, TAVALISSE, GAVRETO, and REZLIDHIA. Moving to slide nine, which shows our product revenue for Q2 2026. We generated $67 million in US net product sales, an increase of $8.1 million over Q2 2025, representing a 14% increase year-over-year. For TAVALISSE, we reported another strong quarter in which we generated a record $47.4 million in net product sales, an increase of 18% compared to Q2 2025, which was aided by favorable gross to net and inventory dynamics. TAVALISSE was launched in 2018, and we're pleased to see continued contribution from this mature product. For GAVRETO, we delivered $10.7 million in net product sales, a decrease of 10% compared to Q2 2025. GAVRETO continues to be a stable, contributing product in our portfolio.

Speaker #2: We generated $67 million in US net product sales and increase of 8.1 million over the second quarter of 2025, representing a 14% increase year over year.

Speaker #2: For Tobilies, we reported another strong quarter in which we generated a record $47.4 million in net product sales, an increase of 18% compared to the second quarter of 2025, which was aided by favorable gross-to-net and inventory dynamics.

Speaker #2: Tobilies was launched in 2018 and we're pleased to see continued contribution from this mature product. For Gevreto, we delivered 10.7 million in net product sales, a decrease of 10% compared to the second quarter of 2025.

Speaker #2: Gevreto continues to be a stable, contributing product in our portfolio. And finally, for Reslidia, we reported $8.9 million in net product sales, an increase of 27% compared to the prior year period.

David A. Santos: Finally, for REZLIDHIA, we reported $8.9 million in net product sales, an increase of 27% compared to the prior year period. During the quarter, we saw growing community use consistent with our efforts to expand adoption in that setting. We believe emerging frontline venetoclax data may further reinforce the relevance of REZLIDHIA in the post-venetoclax setting and improve adoption in the community. We believe that these efforts and data can be elements to continued REZLIDHIA growth into the future. Overall, we are pleased with our second quarter results. While VEPPANU will become our lead focus upon commercial availability, we remain committed to supporting TAVALISSE, REZLIDHIA, and GAVRETO. Moving to slide 10, we generated $11.7 million in revenues from collaborations in the second quarter, driven by the availability of TAVALISSE in global markets and a regulatory milestone payment for olutasidenib.

Dave Santos: Finally, for REZLIDHIA, we reported $8.9 million in net product sales, an increase of 27% compared to the prior year period. During the quarter, we saw growing community use consistent with our efforts to expand adoption in that setting. We believe emerging frontline venetoclax data may further reinforce the relevance of REZLIDHIA in the post-venetoclax setting and improve adoption in the community. We believe that these efforts and data can be elements to continued REZLIDHIA growth into the future. Overall, we are pleased with our second quarter results. While VEPPANU will become our lead focus upon commercial availability, we remain committed to supporting TAVALISSE, REZLIDHIA, and GAVRETO. Moving to slide 10, we generated $11.7 million in revenues from collaborations in the second quarter, driven by the availability of TAVALISSE in global markets and a regulatory milestone payment for olutasidenib.

Speaker #2: During the quarter, we saw growing community use, consistent with our efforts to expand adoption in that setting. We believe emerging front-line venetoclax data may further reinforce the relevance of Reslidia in the post-venetoclax setting and improve adoption in the community.

Speaker #2: We believe that these efforts and data can be elements for continued Rezlidia growth into the future. Overall, we're pleased with our second quarter results.

Speaker #2: While Bepanu will become our lead focus upon commercial availability, we remain committed to supporting Tobilies, Reslidia, and Gevreto. Moving to slide 10, we generated $11.7 million in revenues from collaborations in the second quarter, driven by the availability of Tobilies in global markets and a regulatory milestone payment for a leucocytinib.

Speaker #2: Our partners continue to pursue regulatory approvals for both Tobilies and Reslidia in new markets. In May, our partner Knight commercially launched Tobilies in Mexico and they achieved regulatory approval of Tobilies in Brazil with plans to commercially launch there in the second half of 2026.

David A. Santos: Our partners continue to pursue regulatory approvals for both TAVALISSE and REZLIDHIA in new markets. In May, our partner, Knight, commercially launched TAVALISSE in Mexico, and they achieved regulatory approval of TAVALISSE in Brazil, with plans to commercially launch there in H2 2026. Also in May, Kissei announced they submitted a new drug application for olutasidenib for marketing approval in Japan. We are delighted that access to our products is expanding outside the US. With that, I will now turn attention to the newest addition to our commercial portfolio, VEPPANU or vepdegestrant. I am now on slide 12. VEPPANU is FDA approved for the treatment of adults with ER-positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer as detected by an FDA-authorized test with disease progression following at least one line of endocrine therapy.

Dave Santos: Our partners continue to pursue regulatory approvals for both TAVALISSE and REZLIDHIA in new markets. In May, our partner, Knight, commercially launched TAVALISSE in Mexico, and they achieved regulatory approval of TAVALISSE in Brazil, with plans to commercially launch there in H2 2026. Also in May, Kissei announced they submitted a new drug application for olutasidenib for marketing approval in Japan. We are delighted that access to our products is expanding outside the US. With that, I will now turn attention to the newest addition to our commercial portfolio, VEPPANU or vepdegestrant. I am now on slide 12. VEPPANU is FDA approved for the treatment of adults with ER-positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer as detected by an FDA-authorized test with disease progression following at least one line of endocrine therapy.

Speaker #2: Also in May, Keisei announced they submitted a new drug application for leucocytinib for marketing approval in Japan. We are delighted that access to our products is expanding outside the US.

Speaker #2: With that, I'll now turn attention to the newest addition to our commercial portfolio, Bepanu, or Bepanugestrin. I'm now on slide 12. Bepanu is FDA-approved for the treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced dermatostatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

Speaker #2: Moving to slide 13, we believe Bepanu has the potential to transform our commercial portfolio. Importantly, Bepanu is the first and only approved PROTAC, a new class of targeted agents.

David A. Santos: Moving to slide 13, we believe VEPPANU has the potential to transform our commercial portfolio. Importantly, VEPPANU is the first and only approved PROTAC, a new class of targeted agents. It has a novel mechanism of action and potential to be an important new treatment option for patients. We believe our proven commercial and medical expertise and organization enable us to successfully commercialize VEPPANU. We integrated both REZLIDHIA and GAVRETO into our portfolio over the last four years, and that experience served us well as we needed to quickly integrate VEPPANU to ensure readiness in such a short amount of time. Lastly, importantly, we believe moving forward that VEPPANU has the potential to become Rigel's largest revenue producer. On slide 14, I will take you through the unique biology of proteolysis targeting chimeras, or PROTACs, which are bifunctional small molecules that destroy specific disease-causing proteins rather than just inhibiting them.

Dave Santos: Moving to slide 13, we believe VEPPANU has the potential to transform our commercial portfolio. Importantly, VEPPANU is the first and only approved PROTAC, a new class of targeted agents. It has a novel mechanism of action and potential to be an important new treatment option for patients. We believe our proven commercial and medical expertise and organization enable us to successfully commercialize VEPPANU. We integrated both REZLIDHIA and GAVRETO into our portfolio over the last four years, and that experience served us well as we needed to quickly integrate VEPPANU to ensure readiness in such a short amount of time. Lastly, importantly, we believe moving forward that VEPPANU has the potential to become Rigel's largest revenue producer. On slide 14, I will take you through the unique biology of proteolysis targeting chimeras, or PROTACs, which are bifunctional small molecules that destroy specific disease-causing proteins rather than just inhibiting them.

Speaker #2: It has a novel mechanism of action and the potential to be an important new treatment option for patients. We believe our proven commercial and medical expertise and organization enable us to successfully commercialize Bepanu.

Speaker #2: We integrated both Reslidia and Gevreto into our portfolio over the last four years, and that experience served us well as we needed to quickly integrate Bepanu to ensure readiness in such a short amount of time.

Speaker #2: Lastly, and importantly, we believe moving forward that Bepanu has the potential to become Rigel's largest revenue producer. On slide 14, I'll take you through the unique biology of proteolysis-targeting chimeras, or PROTACs, which are bifunctional small molecules that destroy specific disease-causing proteins rather than just inhibiting them.

Speaker #2: The Bepanu PROTAC design consists of three parts: a targeting ligand that binds to the estrogen receptor, a recruiting ligand that binds to the E3 ligase complex, and a linker connecting them.

David A. Santos: The VEPPANU PROTAC design consists of three parts, a targeting ligand that binds to the estrogen receptor or ER, a recruiting ligand that binds to the E3 ligase complex, and a linker connecting them. This unique design represents a major innovation in ER degradation. First, VEPPANU binds to an ER and recruits an E3 ligase complex to tag the receptor with a chain of ubiquitin proteins. Next, the ubiquitin-tagged ER is then recognized and eliminated by the proteasome, the cell's natural waste disposal system. Because VEPPANU bonds transiently and reversibly on both ends, it can repeat the process multiple times, allowing a single PROTAC to degrade many ERs. Because of VEPPANU's unique design and mechanism of action, it is the first in a novel pharmacologic class of heterobifunctional protein degraders, which is differentiated from other estrogen receptor antagonists which only bind to the estrogen receptors.

Dave Santos: The VEPPANU PROTAC design consists of three parts, a targeting ligand that binds to the estrogen receptor or ER, a recruiting ligand that binds to the E3 ligase complex, and a linker connecting them. This unique design represents a major innovation in ER degradation. First, VEPPANU binds to an ER and recruits an E3 ligase complex to tag the receptor with a chain of ubiquitin proteins. Next, the ubiquitin-tagged ER is then recognized and eliminated by the proteasome, the cell's natural waste disposal system. Because VEPPANU bonds transiently and reversibly on both ends, it can repeat the process multiple times, allowing a single PROTAC to degrade many ERs. Because of VEPPANU's unique design and mechanism of action, it is the first in a novel pharmacologic class of heterobifunctional protein degraders, which is differentiated from other estrogen receptor antagonists which only bind to the estrogen receptors.

Speaker #2: This unique design represents a major innovation in degradation. First, Bepanu binds to an and recruits an E3 ligase complex to tag the receptor with a chain of ubiquitin proteins.

Speaker #2: Next, the ubiquitin-tagged is then recognized and eliminated by the proteasome, the cell's natural waste disposal system. And because Bepanu bonds transiently and reversibly on both ends, it can repeat the process multiple times, allowing a single PROTAC to degrade many ERs.

Speaker #2: Because of Bepanu's unique design and mechanism of action, it is the first in a novel pharmacologic class of heterobifunctional protein degraders, which is differentiated from other estrogen receptor agonists which only bind to the estrogen receptors.

Speaker #2: Moving on to slide 15, I'd like to review the significant patient opportunity for Bepanu. There are an estimated 170,000 patients in the US living with metastatic breast cancer.

David A. Santos: Moving on to slide 15, I'd like to review the significant patient opportunity for VEPPANU. There are an estimated 170,000 patients in the US living with metastatic breast cancer, and approximately 70%, or 119,000 patients, have ER-positive, HER2-negative disease. The standard of care typically includes endocrine therapy and a CDK4/6 inhibitor, and over time, up to 50% of patients may develop an ESR1 mutation. In VERITAC-2, all patients had received endocrine therapy and a CDK4/6 inhibitor, and 43% had an ESR1 mutation. Using approximately 40% as a benchmark, more than 47,000 ER-positive, HER2-negative patients could have the ESR1 mutated disease. Based on our internal market research, we assume that approximately 60% of these patients are diagnosed and treated annually. Because ESR1 mutations generally emerge after exposure to endocrine therapy and CDK4/6 inhibitors, most of these patients are in the second-line or later setting.

Dave Santos: Moving on to slide 15, I'd like to review the significant patient opportunity for VEPPANU. There are an estimated 170,000 patients in the US living with metastatic breast cancer, and approximately 70%, or 119,000 patients, have ER-positive, HER2-negative disease. The standard of care typically includes endocrine therapy and a CDK4/6 inhibitor, and over time, up to 50% of patients may develop an ESR1 mutation. In VERITAC-2, all patients had received endocrine therapy and a CDK4/6 inhibitor, and 43% had an ESR1 mutation. Using approximately 40% as a benchmark, more than 47,000 ER-positive, HER2-negative patients could have the ESR1 mutated disease. Based on our internal market research, we assume that approximately 60% of these patients are diagnosed and treated annually. Because ESR1 mutations generally emerge after exposure to endocrine therapy and CDK4/6 inhibitors, most of these patients are in the second-line or later setting.

Speaker #2: And approximately 70%, or 119,000 patients, have ER-positive, HER2-negative disease. The standard of care typically includes endocrine therapy and a CDK4/6 inhibitor, and over time, up to 50% of patients may develop an ESR1 mutation.

Speaker #2: In Veritac2, all patients had received endocrine therapy and a CDK4/6 inhibitor, and 43% had an ESR1 mutation. So, using approximately 40% as a benchmark, more than 47,000 ER-positive, HER2-negative patients could have ESR1-mutated disease.

Speaker #2: Based on our internal market research, we assume that approximately 60% of these patients are diagnosed and treated annually. Because ESR1 mutations generally emerge after exposure to endocrine therapy and CDK4/6 inhibitors, most of these patients are in the second line or later setting.

Speaker #2: This results in an estimated 20,000 U.S. patients diagnosed and treated annually with second-line or later, ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer. Overall, we believe this represents a U.S. market opportunity of more than $1 billion.

David A. Santos: This results in an estimated 20,000 US patients diagnosed and treated annually with second-line or later ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer. Overall, we believe this represents a US market opportunity of more than $1 billion. Moving to slide 16, I wanted to provide some background on current treatments for second-line and later ESR1-mutated metastatic breast cancer. First, and importantly, in the blue portions of the bars, you can see how oral SERDs have rapidly become the treatment of choice in the second-line setting, garnering nearly 60% share since they've been introduced. Even in the third-line setting, oral SERDs make up nearly 30% of treatment. This demonstrates how eager clinicians have been to find new options versus older treatments like fulvestrant, chemotherapy, and other therapies.

Dave Santos: This results in an estimated 20,000 US patients diagnosed and treated annually with second-line or later ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer. Overall, we believe this represents a US market opportunity of more than $1 billion. Moving to slide 16, I wanted to provide some background on current treatments for second-line and later ESR1-mutated metastatic breast cancer. First, and importantly, in the blue portions of the bars, you can see how oral SERDs have rapidly become the treatment of choice in the second-line setting, garnering nearly 60% share since they've been introduced. Even in the third-line setting, oral SERDs make up nearly 30% of treatment. This demonstrates how eager clinicians have been to find new options versus older treatments like fulvestrant, chemotherapy, and other therapies.

Speaker #2: Moving to slide 16, I wanted to provide some background on current treatments for second line and later ESR1-mutated metastatic breast cancer. First, and importantly, in the blue portions of the bars, you can see how oral surge have rapidly become the treatment of choice in the second line setting, garnering nearly 60% share since they've been introduced.

Speaker #2: Even in the third-line setting, oral SERDs make up nearly 30% of treatment. This demonstrates how eager clinicians have been to find new options versus older treatments like fulvestrant, chemotherapy, and other therapies.

Speaker #2: That said, those options still make up more than 40% of treatment in the second line setting, and most of the treatment in the third line setting.

David A. Santos: That said, those options still make up more than 40% of treatment in the second-line setting, and most of the treatment in the third-line setting. The adoption of oral SERDs has been the strongest in academic centers, where ESR1 testing and awareness of new therapies are higher. However, approximately 80% of metastatic breast cancer patients are treated in community practices, where oral SERD adoption remains lower. That creates a meaningful opportunity to increase awareness and use of VEPPANU as a new oral treatment option. Moving to slide 17, we believe that VEPPANU has the potential to become a market-leading treatment. In addition to VEPPANU being the first and only PROTAC with a novel mechanism of action, there are three reasons we believe this. First, vepdegestrant demonstrated impressive efficacy in the Phase III VERITAC-2 clinical trial with a significant improvement in median PFS, a 2.4-fold improvement, and meaningful responses.

Dave Santos: That said, those options still make up more than 40% of treatment in the second-line setting, and most of the treatment in the third-line setting. The adoption of oral SERDs has been the strongest in academic centers, where ESR1 testing and awareness of new therapies are higher. However, approximately 80% of metastatic breast cancer patients are treated in community practices, where oral SERD adoption remains lower. That creates a meaningful opportunity to increase awareness and use of VEPPANU as a new oral treatment option. Moving to slide 17, we believe that VEPPANU has the potential to become a market-leading treatment. In addition to VEPPANU being the first and only PROTAC with a novel mechanism of action, there are three reasons we believe this. First, vepdegestrant demonstrated impressive efficacy in the Phase III VERITAC-2 clinical trial with a significant improvement in median PFS, a 2.4-fold improvement, and meaningful responses.

Speaker #2: The adoption of oral SERDs has been the strongest in academic centers, where ESR1 testing and awareness of new therapies are higher. However, approximately 80% of metastatic breast cancer patients are treated in community practices, where oral SERD adoption remains lower.

Speaker #2: That creates a meaningful opportunity to increase awareness and use of Bepanu as a new oral treatment option. Moving to slide 17, we believe that Bepanu has the potential to become a market-leading treatment.

Speaker #2: In addition to Bepanu being the first and only PROTAC with a novel mechanism of action, there are three reasons we believe this. First, Veftagestrant demonstrated impressive efficacy in the phase III Veritac2 clinical trial, with a significant improvement in median PFS, a 2.4-fold improvement.

Speaker #2: And meaningful responses. Allison will walk you through the data from the trial in a few minutes. Second, veftagestrant demonstrated tolerability in the Phase 3 VERITAC-2 study, with a manageable safety profile and low rates and severity of GI-related events.

David A. Santos: Alison will walk you through the data from the trial in a few minutes. Second, vepdegestrant demonstrated tolerability in the Phase III VERITAC-2 study with a manageable safety profile and low rates and severity of GI-related events, mainly vomiting and diarrhea, which can be challenging for patients on other metastatic breast cancer treatments. Indeed, as a marker of being well-tolerated, just 3% of patients discontinued and only 2% required dose reductions. These are important differentiators in this market. Last, we believe that the real-world applicability of the patient population in VERITAC-2 is meaningful to clinicians. The standard of care for ER-positive, HER2-negative metastatic breast cancer patients is to use endocrine therapy and a CDK4/6 inhibitor. Vepdeg demonstrated efficacy, safety, and tolerability in exactly this setting in VERITAC-2, where 100% of patients received a CDK4/6 inhibitor and endocrine therapy as previous treatment for their disease.

Dave Santos: Alison will walk you through the data from the trial in a few minutes. Second, vepdegestrant demonstrated tolerability in the Phase III VERITAC-2 study with a manageable safety profile and low rates and severity of GI-related events, mainly vomiting and diarrhea, which can be challenging for patients on other metastatic breast cancer treatments. Indeed, as a marker of being well-tolerated, just 3% of patients discontinued and only 2% required dose reductions. These are important differentiators in this market. Last, we believe that the real-world applicability of the patient population in VERITAC-2 is meaningful to clinicians. The standard of care for ER-positive, HER2-negative metastatic breast cancer patients is to use endocrine therapy and a CDK4/6 inhibitor. Vepdeg demonstrated efficacy, safety, and tolerability in exactly this setting in VERITAC-2, where 100% of patients received a CDK4/6 inhibitor and endocrine therapy as previous treatment for their disease.

Speaker #2: Mainly vomiting and diarrhea, which can be challenging for patients on other metastatic breast cancer treatments. Indeed, as a marker of being well tolerated, just 3% of patients discontinued, and only 2% required dose reductions.

Speaker #2: These are important differentiators in this market. Last, we believe that the real-world applicability of the patient population in Veritac2 is meaningful to clinicians. The standard of care for ER-positive, HER2-negative metastatic breast cancer patients is to use endocrine therapy and a CDK4/6 inhibitor.

Speaker #2: Veftag demonstrated efficacy, safety, and tolerability in exactly this setting in Veritac2, where 100% of patients received a CDK4/6 inhibitor and endocrine therapy as previous treatment for their disease.

Speaker #2: Based on these data, the NCCN, or National Comprehensive Cancer Network, added Vepdegestrant to the NCCN Clinical Practice Guidelines for breast cancer as a category 2A targeted therapy for HR-positive, HER2-negative, ESR1 mutation, for recurrent unresectable or stage IV disease.

David A. Santos: Based on these data, the NCCN, or National Comprehensive Cancer Network, added vepdegestrant to the NCCN clinical practice guidelines for breast cancer as a Category 2A targeted therapy treatment option for HR-positive, HER2-negative ESR1 mutation for recurrent, unresectable, or Stage 4 disease. Overall, we see significant potential for VEPPANU as a valuable new option in the treatment armamentarium for both academic and community physicians as they treat second-line and later ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer. Let's turn to commercialization planning, which you'll see on slide 18. Thanks to close coordination and the strong partnerships we have, we are on track to make VEPPANU available in mid-August, which is ahead of schedule compared to our initial expectations. We've prepared key stakeholders for commercial availability, including distributors, patient services providers, payers, and GPOs.

Dave Santos: Based on these data, the NCCN, or National Comprehensive Cancer Network, added vepdegestrant to the NCCN clinical practice guidelines for breast cancer as a Category 2A targeted therapy treatment option for HR-positive, HER2-negative ESR1 mutation for recurrent, unresectable, or Stage 4 disease. Overall, we see significant potential for VEPPANU as a valuable new option in the treatment armamentarium for both academic and community physicians as they treat second-line and later ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer. Let's turn to commercialization planning, which you'll see on slide 18. Thanks to close coordination and the strong partnerships we have, we are on track to make VEPPANU available in mid-August, which is ahead of schedule compared to our initial expectations. We've prepared key stakeholders for commercial availability, including distributors, patient services providers, payers, and GPOs.

Speaker #2: Overall, we see significant potential for Bepanu as a valuable new option in the treatment armamentarium for both academic and community physicians as they treat second-line and later, ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer.

Speaker #2: Now, let's turn to commercialization planning, which you'll see on slide 18. First, thanks to close coordination and the strong partnerships, we will make Bepanu available in mid-August, which is ahead of expectations.

Speaker #2: Second, we've prepared key stakeholders for commercial availability, including distributors, patient services providers, payers, and GPOs. And further, we engaged with breast cancer key opinion leaders and identified key accounts in advance of commercial availability, based on our market research, launch forums, and other activation initiatives.

David A. Santos: Further, we engage with breast cancer key opinion leaders and identified key accounts in advance of commercial availability based on our market research, launch forums, and other activation initiatives. Third, our teams fully leveraged our experience to immediately deploy critical promotional activities. After the transaction closed, vepneu.com went live. Importantly, our sales team was fully trained in record time and began enthusiastically driving awareness of VEPPANU's approval and near-term commercial availability. In addition, Rigel OneCare, our patient services hub, is now live and ready to serve healthcare providers and patients to ensure prompt access to VEPPANU upon commercial availability. On slide 19, you'll see our three-phase launch roadmap and examples of the VEPPANU marketing materials. Following the transaction close, we immediately activated our now approved campaign.

Dave Santos: Further, we engage with breast cancer key opinion leaders and identified key accounts in advance of commercial availability based on our market research, launch forums, and other activation initiatives. Third, our teams fully leveraged our experience to immediately deploy critical promotional activities. After the transaction closed, vepneu.com went live. Importantly, our sales team was fully trained in record time and began enthusiastically driving awareness of VEPPANU's approval and near-term commercial availability. In addition, Rigel OneCare, our patient services hub, is now live and ready to serve healthcare providers and patients to ensure prompt access to VEPPANU upon commercial availability. On slide 19, you'll see our three-phase launch roadmap and examples of the VEPPANU marketing materials. Following the transaction close, we immediately activated our now approved campaign.

Speaker #2: And third, our teams fully leveraged our experience to immediately deploy critical promotional activities. After the transaction closed, Bepanu.com went live. And importantly, our sales team was fully trained in record time and began enthusiastically driving awareness of Bepanu's approval and near-term commercial availability.

Speaker #2: In addition, Raja OneCare, our patient services hub, is now live and ready to serve healthcare providers and patients to ensure prompt access to Bepanu upon commercial availability.

Speaker #2: And on slide 19, you'll see our three-phase launch roadmap and examples of the Bepanu marketing materials. Following the transaction close, we immediately activated our now-approved campaign.

Speaker #2: We launched Bepanu.com, added Bepanu to the Raja OneCare and medical information websites, and provided initial materials to our sales force. With commercial availability this month, we're launching the next phase of materials to support customer engagement and patient startups.

David A. Santos: We launched vepneu.com, added VEPPANU to the Rigel OneCare and medical information websites, and provided initial materials to our sales force. With commercial availability this month, we're launching the next phase of materials to support customer engagement and patient starts. These include a VERITAC-2 publication overview, dosing and administration guidance, a distribution guide, and patient resources. In Q4, we expect to begin our branded campaign using an omni-channel approach to expand awareness and adoption among healthcare providers and patients. Our organization has moved quickly to put our patient services, the field team, and promotional resources in place as quickly as possible. We're proud of what the organization has accomplished since closing and are fully ready to make VEPPANU available to patients and drive rapid awareness and adoption. My sincere thanks to the entire Rigel team for all their hard work and commitment.

Dave Santos: We launched vepneu.com, added VEPPANU to the Rigel OneCare and medical information websites, and provided initial materials to our sales force. With commercial availability this month, we're launching the next phase of materials to support customer engagement and patient starts. These include a VERITAC-2 publication overview, dosing and administration guidance, a distribution guide, and patient resources. In Q4, we expect to begin our branded campaign using an omni-channel approach to expand awareness and adoption among healthcare providers and patients. Our organization has moved quickly to put our patient services, the field team, and promotional resources in place as quickly as possible. We're proud of what the organization has accomplished since closing and are fully ready to make VEPPANU available to patients and drive rapid awareness and adoption. My sincere thanks to the entire Rigel team for all their hard work and commitment.

Speaker #2: These include a Veritac 2 publication overview, dosing and administration guidance, a distribution guide, and patient resources. And in the fourth quarter, we expect to begin our branded campaign using an omnichannel approach to expand awareness and adoption among healthcare providers and patients.

Speaker #2: Our organization has moved quickly to put our patient services, field team, and promotional resources in place as quickly as possible. We're proud of what the organization has accomplished since closing, and are fully ready to make Bepanu available to patients and drive rapid awareness and adoption.

Speaker #2: My sincere thanks to the entire Rigel team for all their hard work and commitment. And with that, I'll turn the call over to Allison for a review of the data from the Phase III VERITAC-2 clinical trial and ongoing development of veftagestrant, and to update you on our development pipeline.

David A. Santos: With that, I'll turn the call over to Alison for a review of the data from the phase III VERITAC-2 clinical trial and ongoing development of vepdegestrant, and to update you on our development pipeline. Alison?

Dave Santos: With that, I'll turn the call over to Alison for a review of the data from the phase III VERITAC-2 clinical trial and ongoing development of vepdegestrant, and to update you on our development pipeline. Alison?

Speaker #2: Allison?

Speaker #1: Thank you, Dave. I'm very excited to join Rigel at this important stage in the company's evolution. Having served on Rigel's board since 2021, I've seen firsthand the strength of this team, the scientific rationale behind our programs, and the opportunity we have to advance meaningful new therapies for patients with hematological disorders and other cancers.

Alison L. Hannah: Thank you, Dave. I'm very excited to join Rigel at this important stage in the company's evolution. Having served on Rigel's board since 2021, I've seen firsthand the strength of this team, the scientific rationale behind our programs, and the opportunity we have to advance meaningful new therapies for patients with hematological disorders and other cancers. I'm happy to tell you about the continued development of R289 and Rigel's broader clinical strategy, including the recent addition of vepdegestrant. With that, let me walk you through Rigel's plans to advance our development pipeline. First, I'd like to start with the clinical data from vepdegestrant, which underlies its approval by the FDA and gives us confidence in its potential to help patients. I'm now on slide 22, which shows the design of the VERITAC-2 clinical trial.

Alison Hannah: Thank you, Dave. I'm very excited to join Rigel at this important stage in the company's evolution. Having served on Rigel's board since 2021, I've seen firsthand the strength of this team, the scientific rationale behind our programs, and the opportunity we have to advance meaningful new therapies for patients with hematological disorders and other cancers. I'm happy to tell you about the continued development of R289 and Rigel's broader clinical strategy, including the recent addition of vepdegestrant. With that, let me walk you through Rigel's plans to advance our development pipeline. First, I'd like to start with the clinical data from vepdegestrant, which underlies its approval by the FDA and gives us confidence in its potential to help patients. I'm now on slide 22, which shows the design of the VERITAC-2 clinical trial.

Speaker #1: I'm happy to tell you about the continued development of R289 and Ragil's broader clinical strategy, including the recent addition of Veftagestrant. With that, let me walk you through Ragil's plans to advance our development pipeline.

Speaker #1: First, I'd like to start with the clinical data from Veftagestrant, which underlies its approval by the FDA and gives us confidence in its potential to help patients.

Speaker #1: I'm now on slide 22, which shows the design of the Veritac2 clinical trial. It was a global phase III trial evaluating Veftagestrant versus Fulvestrant, a drug initially approved by the FDA in 2002 in patients with ER-positive HER2-negative ESR1-mutated advanced or metastatic breast cancer.

Alison L. Hannah: It was a global phase III trial evaluating vepdegestrant versus fulvestrant, a drug initially approved by the FDA in 2002 in patients with ER-positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer. Patients were at least 18 years old and had ER-positive, HER2-negative, advanced or metastatic breast cancer, and all patients had already received endocrine therapy in combination with a CDK4/6 inhibitor. Patients were permitted to receive up to one additional line of endocrine therapy, and they needed to have been on their most recent line of endocrine therapy for at least 6 months. They were not allowed to have had a prior third, whether that was fulvestrant or elacestrant, and they could not have had prior cytotoxic chemotherapy for metastatic disease. Patients were randomized in a one-to-one fashion to receive either fulvestrant given at its approved dosing or vepdegestrant, 200 milligrams orally, once daily.

Alison Hannah: It was a global phase III trial evaluating vepdegestrant versus fulvestrant, a drug initially approved by the FDA in 2002 in patients with ER-positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer. Patients were at least 18 years old and had ER-positive, HER2-negative, advanced or metastatic breast cancer, and all patients had already received endocrine therapy in combination with a CDK4/6 inhibitor. Patients were permitted to receive up to one additional line of endocrine therapy, and they needed to have been on their most recent line of endocrine therapy for at least 6 months. They were not allowed to have had a prior third, whether that was fulvestrant or elacestrant, and they could not have had prior cytotoxic chemotherapy for metastatic disease. Patients were randomized in a one-to-one fashion to receive either fulvestrant given at its approved dosing or vepdegestrant, 200 milligrams orally, once daily.

Speaker #1: Patients were at least 18 years old and had ER-positive, HER2-negative advanced or metastatic breast cancer, and all patients had already received endocrine therapy in combination with a CDK4/6 inhibitor.

Speaker #1: Patients were permitted to receive up to one additional line of endocrine therapy and they needed to have been on their most recent line of endocrine therapy for at least six months.

Speaker #1: They were not allowed to have had a prior surge whether that was Fulvestrant, or Elifestrant, and they could not have had prior cytotoxic chemotherapy for metastatic disease.

Speaker #1: Patients were randomized in a one-to-one fashion, to receive either Fulvestrant, given at its approved dosing, or Veftagestrant, 200 milligrams orally once daily. The primary efficacy endpoint was progression-free survival by blinded independent central review.

Alison L. Hannah: The primary efficacy endpoint was progression-free survival by blinded independent central review. Initially, in those patients with ESR1 mutations, if positive, then we would subsequently test progression-free survival among all patients, the ITT population. Secondary endpoints included overall survival, clinical benefit rate, objective response rate, as well as adverse events and tolerability. Moving to slide 23, we show the primary endpoint, PFS, by blinded independent central review among the patients with the ESR1 mutations. Median PFS was 5.0 months for those patients receiving vepdegestrant, where it was only 2.1 months for those patients receiving fulvestrant. This was very much in line with what we expected of how a fulvestrant control arm would perform in this population. The hazard ratio was 0.57 for a statistically significant P value of less than 0.001. You can see the landmark analyses at 6 months progression-free survival.

Alison Hannah: The primary efficacy endpoint was progression-free survival by blinded independent central review. Initially, in those patients with ESR1 mutations, if positive, then we would subsequently test progression-free survival among all patients, the ITT population. Secondary endpoints included overall survival, clinical benefit rate, objective response rate, as well as adverse events and tolerability. Moving to slide 23, we show the primary endpoint, PFS, by blinded independent central review among the patients with the ESR1 mutations. Median PFS was 5.0 months for those patients receiving vepdegestrant, where it was only 2.1 months for those patients receiving fulvestrant. This was very much in line with what we expected of how a fulvestrant control arm would perform in this population. The hazard ratio was 0.57 for a statistically significant P value of less than 0.001. You can see the landmark analyses at 6 months progression-free survival.

Speaker #1: Initially, in those patients with ESR1 mutations, if positive, then we would subsequently test progression-free survival among all patients—the ITT population. Secondary endpoints included overall survival, clinical benefit rate, objective response rate, as well as adverse events and tolerability.

Speaker #1: Moving to slide 23, we show the primary endpoint PFS by blinded independent central review. Among the patients, with the ESR1 mutations. Median PFS was 5.0 months for those patients receiving Veftagestrant, where it was only 2.1 months for those patients receiving Fulvestrant.

Speaker #1: This was very much in line with what we expected of how a Fulvestrant control arm would perform in this population. The hazard ratio was 0.57 for a statistically significant p-value, of less than 0.001.

Speaker #1: You can see the landmark analyses at six months, progression-free survival, approximately double the percentage of patients remaining progression-free at six months who are receiving Veftagestrant, compared to those patients receiving Fulvestrant.

Alison L. Hannah: They approximately doubled the percentage of patients remaining progression free at 6 months who are receiving vepdegestrant compared to those patients receiving fulvestrant. Slide 24 shows important secondary endpoints, clinical benefit rate, and objective response rate by blinded independent central review. In patients with ESR1 mutations, the clinical benefit rate more than doubled with vepdegestrant at 42% compared to 20% with fulvestrant. In terms of objective response rate, vepdegestrant more than quadrupled the ORR observed with fulvestrant in a breast cancer population known to have a relatively low objective response rate. Only 4% of patients receiving single agent fulvestrant had an objective response, compared to 18.6% of patients who received vepdegestrant. Turning to safety and tolerability on slide 25, grade 3 or higher treatment emergent adverse events occurred in 23% of patients receiving vepdegestrant and 18% of patients receiving fulvestrant.

Alison Hannah: They approximately doubled the percentage of patients remaining progression free at 6 months who are receiving vepdegestrant compared to those patients receiving fulvestrant. Slide 24 shows important secondary endpoints, clinical benefit rate, and objective response rate by blinded independent central review. In patients with ESR1 mutations, the clinical benefit rate more than doubled with vepdegestrant at 42% compared to 20% with fulvestrant. In terms of objective response rate, vepdegestrant more than quadrupled the ORR observed with fulvestrant in a breast cancer population known to have a relatively low objective response rate. Only 4% of patients receiving single agent fulvestrant had an objective response, compared to 18.6% of patients who received vepdegestrant. Turning to safety and tolerability on slide 25, grade 3 or higher treatment emergent adverse events occurred in 23% of patients receiving vepdegestrant and 18% of patients receiving fulvestrant.

Speaker #1: Slide 24 shows important secondary endpoints, clinical benefit rate, and objective response rate, by blinded independent central review. In patients with ESR1 mutations, the clinical benefit rate more than doubled with Veftagestrant at 42%, compared to 20% with Fulvestrant.

Speaker #1: In terms of objective response rate, Veftagestrant more than quadrupled the ORR observed with Fulvestrant, in a breast cancer population known to have a relatively low objective response rate.

Speaker #1: Only 4% of patients receiving single-agent fulvestrant had an objective response, compared to 18.6% of patients who received veftagestrant. Turning to safety and tolerability on slide 25, grade 3 or higher treatment-emergent adverse events occurred in 23% of patients receiving veftagestrant and 18% of patients receiving fulvestrant.

Speaker #1: Treatment discontinuations and dose reductions due to adverse events were low, with Veftagestrant at 3% and 2%, respectively. The most common treatment-emergent adverse event was fatigue, reported in 27% of patients receiving Veftagestrant.

Alison L. Hannah: Treatment discontinuations and dose reductions due to adverse events were low, with vepdegestrant at 3% and 2% respectively. The most common treatment emergent adverse event was fatigue, reported in 27% of patients receiving vepdegestrant. ALT and AST increases occurred in approximately 14%, with grade 3 or 4 events in only 1%. Nausea occurred in 13%, with no grade 3 or 4 cases. I'd note you do not see diarrhea on this slide because it did not meet the 10% threshold to be included. Any grade diarrhea was only 6% for patients receiving vepdegestrant. Although QT prolongation of any grade was reported in the VERITAC-2 trial, which led to its inclusion in the warning and precaution section of the US package insert, no clinical sequelae were reported.

Alison Hannah: Treatment discontinuations and dose reductions due to adverse events were low, with vepdegestrant at 3% and 2% respectively. The most common treatment emergent adverse event was fatigue, reported in 27% of patients receiving vepdegestrant. ALT and AST increases occurred in approximately 14%, with grade 3 or 4 events in only 1%. Nausea occurred in 13%, with no grade 3 or 4 cases. I'd note you do not see diarrhea on this slide because it did not meet the 10% threshold to be included. Any grade diarrhea was only 6% for patients receiving vepdegestrant. Although QT prolongation of any grade was reported in the VERITAC-2 trial, which led to its inclusion in the warning and precaution section of the US package insert, no clinical sequelae were reported.

Speaker #1: ALT and AST increases occurred in approximately 14%, with grade 3 or 4 events in only 1%. Nausea occurred in 13%, with no grade 3 or 4 cases.

Speaker #1: I'd note you do not see diarrhea on this slide because it did not meet the 10% threshold to be included. Any diarrhea was only 6% for patients receiving Veftagestrant.

Speaker #1: Although QT prolongation of any grade was reported in the Veritac2 trial, which led to its inclusion in the warning and precaution section of the US package insert, no clinical sequelae were reported.

Speaker #1: A dedicated QT sub-study in 88 patients showed a mean QTcF increase from baseline of 11.1 milliseconds, with the upper bound of the 90% confidence interval below 20 milliseconds.

Alison L. Hannah: A dedicated QT sub-study in 88 patients showed a mean QTCF increase from baseline of 11.1 milliseconds, with the upper bound of the 90% confidence interval below 20 milliseconds, indicating no large QT prolonging effect. Overall, the efficacy and manageable safety profile demonstrated in VERITAC-2 supported FDA approval of vepdegestrant for patients with second-line or later ER-positive, HER2-negative, ESR1 mutated, advanced or metastatic breast cancer. As we think about studying vepdegestrant further, on the left side of slide 26, you will see the ongoing studies for which Arvinas and Pfizer will continue to maintain responsibility. As a reminder, all of the studies listed are active but no longer enrolling patients, with the exception of the hepatic impairment study. These studies include the completion of the VERITAC-2 trial for its time to event and disposition endpoints.

Alison Hannah: A dedicated QT sub-study in 88 patients showed a mean QTCF increase from baseline of 11.1 milliseconds, with the upper bound of the 90% confidence interval below 20 milliseconds, indicating no large QT prolonging effect. Overall, the efficacy and manageable safety profile demonstrated in VERITAC-2 supported FDA approval of vepdegestrant for patients with second-line or later ER-positive, HER2-negative, ESR1 mutated, advanced or metastatic breast cancer. As we think about studying vepdegestrant further, on the left side of slide 26, you will see the ongoing studies for which Arvinas and Pfizer will continue to maintain responsibility. As a reminder, all of the studies listed are active but no longer enrolling patients, with the exception of the hepatic impairment study. These studies include the completion of the VERITAC-2 trial for its time to event and disposition endpoints.

Speaker #1: Indicating no significant QT prolongation effect. Overall, the efficacy and manageable safety profile demonstrated in VERITAC-2 supported FDA approval of Veftagestrant for patients with second-line or later ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

Speaker #1: As we think about studying Veftagestrant further, on the left side of slide 26, you will see the ongoing studies for which Arvinas and Pfizer will continue to maintain responsibility.

Speaker #1: As a reminder, all of the studies listed are active but no longer enrolling patients, with the exception of the hepatic impairment study. These studies include the completion of the VERITAC-2 trial for its time-to-event and disposition endpoints. In addition, there are four studies focused on studying veftagestrant in combination with other agents.

Alison L. Hannah: In addition, there are four studies focused on studying vepdegestrant in combination with other agents. We believe these studies will provide additional safety and efficacy data that will be helpful as we evaluate future development opportunities. Now let's move on to our development focus areas. I'm on slide 27. Our hematology and oncology pipeline focus is around the clinical development of R289, our potent and selective dual IRAK1 and IRAK4 inhibitor in lower-risk myelodysplastic syndrome, referred to as MDS, and potentially other indications. I'll spend time providing an update on R289 in a minute. On the right side of the slide, you can see we are evaluating olutasidenib beyond relapsed or refractory IDH1-mutated AML in collaboration with academic partners. MD Anderson is evaluating olutasidenib in multiple clinical studies in IDH1-mutated AML and other hematologic malignancies where IDH1 plays a role.

Alison Hannah: In addition, there are four studies focused on studying vepdegestrant in combination with other agents. We believe these studies will provide additional safety and efficacy data that will be helpful as we evaluate future development opportunities. Now let's move on to our development focus areas. I'm on slide 27. Our hematology and oncology pipeline focus is around the clinical development of R289, our potent and selective dual IRAK1 and IRAK4 inhibitor in lower-risk myelodysplastic syndrome, referred to as MDS, and potentially other indications. I'll spend time providing an update on R289 in a minute. On the right side of the slide, you can see we are evaluating olutasidenib beyond relapsed or refractory IDH1-mutated AML in collaboration with academic partners. MD Anderson is evaluating olutasidenib in multiple clinical studies in IDH1-mutated AML and other hematologic malignancies where IDH1 plays a role.

Speaker #1: We believe these studies will provide additional safety and efficacy data that will be helpful as we evaluate future development opportunities. Now, let's move on to our development focus areas.

Speaker #1: I'm on slide 27. Our hematology and oncology pipeline focus is around the clinical development of R289. Our potent and selective dual IRAC1 and IRAC4 inhibitor in lower-risk myelodysplastic syndrome.

Speaker #1: Referred to as MDS. And potentially other indications, I'll spend time providing an update on R289 in a minute. On the right side of the slide, you can see we are evaluating olutasidenib beyond relapsed or refractory IDH1-mutated AML.

Speaker #1: In collaboration with academic partners, MD Anderson is evaluating leucocytinib in multiple clinical studies in IDH1-mutated AML and other hematologic malignancies where IDH1 plays a role.

Speaker #1: A leucocytinib is also being evaluated as maintenance therapy in IDH1 mutation-positive high-grade glioma by the Connect Cancer Consortium. Lastly, we are partnering with Myelomatch for a planned study in first-line AML and MDS.

Alison L. Hannah: Olutasidenib is also being evaluated as maintenance therapy in IDH1 mutation-positive high-grade glioma by the CONNECT Cancer Consortium. Lastly, we are partnering with MyeloMatch for a planned study in first-line AML and MDS. We look forward to seeing the data that these studies generate in the future. Now I will discuss R289, our novel dual IRAK1 and IRAK4 inhibitor. You can review the R289 slides in full in our corporate presentation that's posted in the investor section of our website. I'll provide a brief update on the program today. I'm now on slide 29. I'd first like to remind you about the treatment landscape for lower-risk MDS. Therapies used in the upfront setting include erythropoiesis stimulating agent, or ESA, if patients are eligible, or luspatercept. Luspatercept, and more recently, imetelstat, are also approved for ESA failure, transfusion-dependent, lower-risk MDS patients.

Alison Hannah: Olutasidenib is also being evaluated as maintenance therapy in IDH1 mutation-positive high-grade glioma by the CONNECT Cancer Consortium. Lastly, we are partnering with MyeloMatch for a planned study in first-line AML and MDS. We look forward to seeing the data that these studies generate in the future. Now I will discuss R289, our novel dual IRAK1 and IRAK4 inhibitor. You can review the R289 slides in full in our corporate presentation that's posted in the investor section of our website. I'll provide a brief update on the program today. I'm now on slide 29. I'd first like to remind you about the treatment landscape for lower-risk MDS. Therapies used in the upfront setting include erythropoiesis stimulating agent, or ESA, if patients are eligible, or luspatercept. Luspatercept, and more recently, imetelstat, are also approved for ESA failure, transfusion-dependent, lower-risk MDS patients.

Speaker #1: We look forward to seeing the data that these studies generate in the future. Now I will discuss R289, our novel dual IRAK1 and IRAK4 inhibitor.

Speaker #1: You can review the R289 slides in full in our corporate presentation, which is posted in the investor section of our website. I'll provide a brief update on the program today.

Speaker #1: I'm now on slide 29. I'd first like to remind you about the treatment landscape for lower-risk MDS. Therapies used in the upfront setting include erythropoiesis-stimulating agents, or ESAs, if patients are eligible.

Speaker #1: Or Lispatricept. Lispatricept and more recently Imitelstep are also approved for ESA failure, transfusion-dependent lower-risk MDS patients. Finally, hypomethylating agents, or HMAs, are also approved; however, the percentage of patients receiving transfusion-independence is low.

Alison L. Hannah: Finally, hypomethylating agents, or HMAs, are also approved. However, the percentage of patients receiving transfusion independence is low. With 8-week transfusion independence rates approaching 40% with Luspatercept and Imetelstat, there is still a need for safe, effective therapies for transfusion-dependent lower risk MDS patients that are relapsed, or refractory, or ineligible for ESAs. On slide 30 is the value proposition of R289 in lower risk MDS. There are about 12,000 previously treated lower risk MDS patients in the United States. As I mentioned, there is a high unmet need for therapies, including transfusion-dependent patients. R289 has a novel mechanism of action as a dual IRAK1 and IRAK4 inhibitor. Blocking both IRAK1 and 4 may suppress marrow inflammation and leukemic stem progenitor cell function and restore normal hematopoiesis. Clinical proof of concept came from a healthy volunteer study in which R835 markedly suppressed LPS-induced cytokine release compared to placebo.

Alison Hannah: Finally, hypomethylating agents, or HMAs, are also approved. However, the percentage of patients receiving transfusion independence is low. With 8-week transfusion independence rates approaching 40% with Luspatercept and Imetelstat, there is still a need for safe, effective therapies for transfusion-dependent lower risk MDS patients that are relapsed, or refractory, or ineligible for ESAs. On slide 30 is the value proposition of R289 in lower risk MDS. There are about 12,000 previously treated lower risk MDS patients in the United States. As I mentioned, there is a high unmet need for therapies, including transfusion-dependent patients. R289 has a novel mechanism of action as a dual IRAK1 and IRAK4 inhibitor. Blocking both IRAK1 and 4 may suppress marrow inflammation and leukemic stem progenitor cell function and restore normal hematopoiesis. Clinical proof of concept came from a healthy volunteer study in which R835 markedly suppressed LPS-induced cytokine release compared to placebo.

Speaker #1: With eight-week transfusion-independence rates approaching 40%, with Lispatricept and Imitelstep, there is still a need for safe, effective therapies for transfusion-dependent lower-risk MDS patients that are relapsed or refractory or ineligible for ESAs.

Speaker #1: On slide 30 is the value proposition of R289 in lower-risk MDS. There are about 12,000 previously treated lower-risk MDS patients in the United States.

Speaker #1: And as I mentioned, there is a high unmet need for therapies, including transfusion-dependent patients. R289 has a novel mechanism of action as a dual IRAC1 and IRAC4 inhibitor.

Speaker #1: Blocking both IRAC1 and IV may suppress marrow inflammation and leukemic stem progenitor cell function. And restore normal hematopoiesis. Clinical proof of concept came from a healthy volunteer study in which our 835 markedly suppressed LPS-induced cytokine release compared to placebo, as a reminder R289 is the oral prodrug that is rapidly converted to our 835 in the gut.

Alison L. Hannah: As a reminder, R289 is the oral prodrug that is rapidly converted to R835 in the gut. From the FDA, R289 has Fast Track designation for the treatment of patients with previously treated transfusion-dependent lower risk MDS and Orphan Drug Designation for MDS, giving the molecule an expedited regulatory pathway, potential priority review, and 7 years of market exclusivity upon approval. R289 has thus far demonstrated a promising clinical profile with both encouraging preliminary safety and efficacy data in our phase I-B study. On slide 31, you can see the design of our multicenter open-label phase I-B study in patients with relapsed or refractory lower risk MDS. The phase I-B study evaluates the safety, tolerability, PK, and preliminary efficacy of R289 in patients with lower risk MDS and is also designed to select a dose for future studies.

Alison Hannah: As a reminder, R289 is the oral prodrug that is rapidly converted to R835 in the gut. From the FDA, R289 has Fast Track designation for the treatment of patients with previously treated transfusion-dependent lower risk MDS and Orphan Drug Designation for MDS, giving the molecule an expedited regulatory pathway, potential priority review, and 7 years of market exclusivity upon approval. R289 has thus far demonstrated a promising clinical profile with both encouraging preliminary safety and efficacy data in our phase I-B study. On slide 31, you can see the design of our multicenter open-label phase I-B study in patients with relapsed or refractory lower risk MDS. The phase I-B study evaluates the safety, tolerability, PK, and preliminary efficacy of R289 in patients with lower risk MDS and is also designed to select a dose for future studies.

Speaker #1: From the FDA, R289 has fast-track designation for the treatment of patients with previously treated transfusion-dependent lower-risk MDS and orphan drug designation for MDS. Giving the molecule an expedited regulatory pathway, potential priority review, and seven years of market exclusivity upon approval.

Speaker #1: R289 has thus far demonstrated a promising clinical profile with both encouraging preliminary safety and efficacy data in our Phase IB study. Now on slide 31, you can see the design of our multicenter open-label Phase IB study in patients with relapsed or refractory lower-risk MDS.

Speaker #1: The Phase 1b study evaluates the safety, tolerability, PK, and preliminary efficacy of R289 in patients with lower-risk MDS, and is also designed to select a dose for future studies.

Speaker #1: In the dose expansion part of the study, which we are enrolling now, up to 40 transfusion-dependent relapsed refractory lower-risk MDS patients will be randomized to receive R289 doses of either 500 milligrams once or 500 milligrams twice daily in order to select the recommended Phase II dose for future clinical studies.

Alison L. Hannah: In the dose expansion part of the study, which we are enrolling now, up to 40 transfusion-dependent relapsed refractory lower risk MDS patients will be randomized to receive R289 doses of either 500 milligrams once or 500 milligrams twice daily in order to select the recommended phase II dose for future clinical studies. On slide 32, you see highlights from the dose escalation phase data presented at ASH meeting in 2025. Again, I encourage you to review the R289 ASH 2025 data slides in full in our corporate presentation. R289 was generally well-tolerated. Of the 18 evaluable patients reading doses of 500 milligrams daily or higher, six patients or 33% achieved red blood cell transfusion independence, or RBCTI, lasting for 8 weeks or longer. In four patients, RBCTI lasted for more than 16 weeks, and for three patients, more than 6 months.

Alison Hannah: In the dose expansion part of the study, which we are enrolling now, up to 40 transfusion-dependent relapsed refractory lower risk MDS patients will be randomized to receive R289 doses of either 500 milligrams once or 500 milligrams twice daily in order to select the recommended phase II dose for future clinical studies. On slide 32, you see highlights from the dose escalation phase data presented at ASH meeting in 2025. Again, I encourage you to review the R289 ASH 2025 data slides in full in our corporate presentation. R289 was generally well-tolerated. Of the 18 evaluable patients reading doses of 500 milligrams daily or higher, six patients or 33% achieved red blood cell transfusion independence, or RBCTI, lasting for 8 weeks or longer. In four patients, RBCTI lasted for more than 16 weeks, and for three patients, more than 6 months.

Speaker #1: On slide 32, you see highlights from the dose escalation phase data presented at ASH meeting in 2025. Again, I encourage you to review the R289 ASH 2025 data slides in full in our corporate presentation.

Speaker #1: R289 was generally well tolerated. Of the 18 evaluable patients, reading doses of 500 milligrams daily or higher six patients or 33% achieved red blood cell transfusion-independence, or RBCTI, lasting for eight weeks or longer.

Speaker #1: In four patients, RBCTI lasted for more than 16 weeks. And for three patients, more than six months. The median duration of RBCTI was approximately 23 weeks, ranging from nine weeks to more than 24 months, median time to onset of RBCTI was about two months.

Alison L. Hannah: The median duration of RBCTI was approximately 23 weeks, ranging from 9 weeks to more than 24 months. Median time to onset of RBCTI was about 2 months. In summary, R289 was generally well-tolerated with an encouraging safety profile and promising efficacy in an elderly, heavily pretreated transfusion-dependent lower risk MDS population. While this is a small data set, we are encouraged by the dose-dependent positive results given the highly refractory nature of these patients. On slide 33 are the next steps for R289. In lower risk MDS, we plan to complete enrollment of the dose escalation phase of the phase I-B study and select the recommended phase II dose for future studies in H2 of this year. We anticipate sharing top-line data from the dose expansion phase by the end of the year.

Alison Hannah: The median duration of RBCTI was approximately 23 weeks, ranging from 9 weeks to more than 24 months. Median time to onset of RBCTI was about 2 months. In summary, R289 was generally well-tolerated with an encouraging safety profile and promising efficacy in an elderly, heavily pretreated transfusion-dependent lower risk MDS population. While this is a small data set, we are encouraged by the dose-dependent positive results given the highly refractory nature of these patients. On slide 33 are the next steps for R289. In lower risk MDS, we plan to complete enrollment of the dose escalation phase of the phase I-B study and select the recommended phase II dose for future studies in H2 of this year. We anticipate sharing top-line data from the dose expansion phase by the end of the year.

Speaker #1: In summary, R289 was generally well tolerated, with an encouraging safety profile and promising efficacy in an elderly, heavily pretreated, transfusion-dependent, lower-risk MDS population. While this is a small data set, we're encouraged by the dose-dependent positive results given the highly refractory nature of these patients.

Speaker #1: On slide 33 are the next steps for R289. In lower-risk MDS, we plan to complete enrollment of the dose escalation phase of the Phase 1B study.

Speaker #1: And select the recommended Phase II dose for future studies in the second half of this year. We anticipate sharing top-line data from the dose expansion phase by the end of the year.

Speaker #1: Once the recommended Phase II dose has been selected, we will evaluate R289 in a cohort of less heavily pretreated patients who are relapsed or refractory to, or ineligible for, ESAs in the same study.

Alison L. Hannah: Once the recommended Phase II dose has been selected, we will evaluate R289 in a cohort of less heavily pretreated patients who are relapsed or refractory to or ineligible for ESAs in the same study.

Alison Hannah: Once the recommended Phase II dose has been selected, we will evaluate R289 in a cohort of less heavily pretreated patients who are relapsed or refractory to or ineligible for ESAs in the same study.

Speaker #1: Upon completion of the Phase IB study, we plan to follow up with the FDA to discuss the potential registration trial. In addition, we are continuing to progress with our evaluation of R289 in other potential indications that align with its mechanism of action and plan to provide an update later this year.

Alison L. Hannah: Upon completion of the Phase I-B study, we plan to follow up with the FDA to discuss a potential registration trial. In addition, we are continuing to progress with our evaluation of R289 and other potential indications that align with its mechanism of action and plan to provide an update later this year. I'll now pass the call to Dean to discuss our financial results for the quarter. Dean?

Alison Hannah: Upon completion of the Phase I-B study, we plan to follow up with the FDA to discuss a potential registration trial. In addition, we are continuing to progress with our evaluation of R289 and other potential indications that align with its mechanism of action and plan to provide an update later this year. I'll now pass the call to Dean to discuss our financial results for the quarter. Dean?

Speaker #1: I'll now pass the call to Dean to discuss our financial results for the quarter. Dean?

Speaker #2: Thank you, Allison. I'm on slide 35. We reported net product sales of $67 million for the second quarter, a growth of 14% year over year, including top-least net product sales of $47.4 million.

Dean Schorno: Thank you, Alison. I'm on slide 35. We reported net product sales of $67 million for the Q2, a growth of 14% year over year, including TAVALISSE net product sales of $47.4 million, a growth of 18% year over year, GAVRETO net product sales of $10.7 million, a modest decline year over year, and REZLIDHIA net product sales of $8.9 million, a growth of 27% year over year. Our net product sales were recorded net of estimated discounts, charge-backs, rebates, returns, co-pay assistance, and other allowances of $21.4 million. We also reported $11.7 million in contract revenues for the Q2, primarily consisting of $5.8 million of revenue from Kissei, which included a $4 million regulatory milestone payment in connection with the marketing authorization application submission for lutetium in Japan, and the delivery of drug supplies.

Dean Schorno: Thank you, Alison. I'm on slide 35. We reported net product sales of $67 million for the Q2, a growth of 14% year over year, including TAVALISSE net product sales of $47.4 million, a growth of 18% year over year, GAVRETO net product sales of $10.7 million, a modest decline year over year, and REZLIDHIA net product sales of $8.9 million, a growth of 27% year over year. Our net product sales were recorded net of estimated discounts, charge-backs, rebates, returns, co-pay assistance, and other allowances of $21.4 million. We also reported $11.7 million in contract revenues for the Q2, primarily consisting of $5.8 million of revenue from Kissei, which included a $4 million regulatory milestone payment in connection with the marketing authorization application submission for lutetium in Japan, and the delivery of drug supplies.

Speaker #2: A growth of 18% year over year. Get reader net product sales of $10.7 million. A modest decline year over year. And resilidia net product sales of $8.9 million, a growth of 27% year over year.

Speaker #2: Our net product sales were recorded net of estimated discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $21.4 $11.7 million in contract revenues for the second quarter, primarily consisting of $5.8 million of revenue from KeySay, which included a $4 million regulatory milestone payment in connection with the marketing authorization application submission for Lutusid Nib in Japan, and the delivery of drug supplies.

Speaker #2: $5 million of revenue from RIFLES, related to earned royalties and delivery of drug supplies, and $300,000 of revenue from Medison, related to delivery of drug supply and earned royalties.

Dean Schorno: $5 million of revenue from Grifols related to earned royalties and delivery of drug supplies, and $300,000 of revenue from Medison related to delivery of drug supply and earned royalties. Our total revenues for the Q2 was $78.7 million. Moving to slide 36. For the Q2 2026, our cost of product sales was approximately $8.5 million. Total costs and expenses were $55.1 million, compared to $40.6 million for the same period of 2025. The increase in costs and expenses was primarily due to increased research and development costs driven by the timing of clinical activities related to R289 and costs associated with development activities under Rigel's license agreement with Arvinas and Pfizer, as well as an increased cost of product sales and higher personnel-related costs. Income before income taxes was $23.6 million.

Dean Schorno: $5 million of revenue from Grifols related to earned royalties and delivery of drug supplies, and $300,000 of revenue from Medison related to delivery of drug supply and earned royalties. Our total revenues for the Q2 was $78.7 million. Moving to slide 36. For the Q2 2026, our cost of product sales was approximately $8.5 million. Total costs and expenses were $55.1 million, compared to $40.6 million for the same period of 2025. The increase in costs and expenses was primarily due to increased research and development costs driven by the timing of clinical activities related to R289 and costs associated with development activities under Rigel's license agreement with Arvinas and Pfizer, as well as an increased cost of product sales and higher personnel-related costs. Income before income taxes was $23.6 million.

Speaker #2: Our total revenues for the second quarter was $78.7 million. Moving to slide 36, for the second quarter of 2026, our cost of product sales was approximately $8.5 million.

Speaker #2: Total cost and expenses were $55.1 million, compared to $40.6 million for the same period of 2025. The increase in cost and expenses was primarily due to increased research and development costs driven by the timing of clinical activities related to R289 and costs associated with development activities under Rigel's license agreement with Arvinas and Pfizer, as well as an increased cost of product sales and higher personnel-related costs.

Speaker #2: Income before income taxes was $23.6 million. We reported net income of $17.3 million for the second quarter, compared to net income of $59.6 million in the same period in 2025.

Dean Schorno: We reported net income of $17.3 million for Q2, compared to net income of $59.6 million in the same period in 2025. As a reminder, Q2 of 2025 included $40 million in non-cash revenue related to Rigel's collaboration agreement with Lilly. We ended the quarter with cash equivalents, and short-term investments of $95.3 million, compared to $155 million as of the end of 2025. Turning to our financial outlook for 2026. We've raised and narrowed our guidance range and expect total revenues in the range of approximately $285 to $295 million. Our guidance range includes our expectation of approximately $255 to $265 million in net product sales, excluding VEPPANU, and approximately $30 million in contract revenues. We also anticipate reported positive net income for the full year, while funding existing and new clinical development programs.

Dean Schorno: We reported net income of $17.3 million for Q2, compared to net income of $59.6 million in the same period in 2025. As a reminder, Q2 of 2025 included $40 million in non-cash revenue related to Rigel's collaboration agreement with Lilly. We ended the quarter with cash equivalents, and short-term investments of $95.3 million, compared to $155 million as of the end of 2025. Turning to our financial outlook for 2026. We've raised and narrowed our guidance range and expect total revenues in the range of approximately $285 to $295 million. Our guidance range includes our expectation of approximately $255 to $265 million in net product sales, excluding VEPPANU, and approximately $30 million in contract revenues. We also anticipate reported positive net income for the full year, while funding existing and new clinical development programs.

Speaker #2: As a reminder, the second quarter of 2025 included $40 million in non-cash revenue related to Rigel's collaboration agreement with Lilly. We ended the quarter with cash, cash equivalents, and short-term investments of $95.3 million compared to $155 million as of the end of 2025.

Speaker #2: Turning to our financial outlook for 2026, we've raised and narrowed our guidance range and expect total revenues in the range of approximately $285 million to $295 million.

Speaker #2: Our guidance range includes our expectation of approximately $255 to $265 million in net product sales excluding revenue and approximately $30 million in contract revenues.

Speaker #2: We also anticipate reporting positive net income for the full year while funding existing and new clinical development programs. On slide 37, I'll review the key transaction terms of our revenue licensing agreement.

Dean Schorno: On slide 37, I'll review the key transaction terms of our VEPPANU licensing agreement. Rigel paid the upfront payment of $70 million following the close of the transaction. Beyond that, there are $15 million in milestones owed to Arvinas and Pfizer tied to the successful completion of transition activities. Arvinas and Pfizer are also eligible to receive potential regulatory and commercial payments totaling up to $320 million. The tiered royalties on cumulative net sales owed to Arvinas and Pfizer range from the mid-teens to the mid-20s. As Alison mentioned, Pfizer and Arvinas remain responsible for the current ongoing development activities for vepdegestrant. Rigel will contribute up to $40 million over the next 4 years in support of these activities. With that, I'd like to turn the call back over to Raul. Raul?

Dean Schorno: On slide 37, I'll review the key transaction terms of our VEPPANU licensing agreement. Rigel paid the upfront payment of $70 million following the close of the transaction. Beyond that, there are $15 million in milestones owed to Arvinas and Pfizer tied to the successful completion of transition activities. Arvinas and Pfizer are also eligible to receive potential regulatory and commercial payments totaling up to $320 million. The tiered royalties on cumulative net sales owed to Arvinas and Pfizer range from the mid-teens to the mid-20s. As Alison mentioned, Pfizer and Arvinas remain responsible for the current ongoing development activities for vepdegestrant. Rigel will contribute up to $40 million over the next 4 years in support of these activities. With that, I'd like to turn the call back over to Raul. Raul?

Speaker #2: Rigel paid the upfront payment of $70 million following the close of the transaction. Beyond that, there are $15 million in milestones owed to Arvinas and Pfizer tied to the successful completion of transition activities.

Speaker #2: Arvinas and Pfizer are also eligible to receive potential regulatory and commercial payments totaling up to $320 million. The tiered royalties on cumulative net sales owed to Arvinas and Pfizer range from the mid-teens to the mid-20s.

Speaker #2: Also, and as Allison mentioned, Pfizer and Arvinas remain responsible for the current ongoing development activities for VEP2 registrants. Rigel will contribute up to $40 million of an next four years in support of these activities.

Speaker #2: With that, I'd like to turn the call back over to Raul. Raul?

Speaker #3: Thank you, Dean. Moving on to slide 38. The first half of 2026 marked significant progress across each of our strategic priorities. Most notably, we closed the VEP2 transaction, adding a fourth FDA-approved product to our portfolio, and creating an important new long-term growth opportunity.

Alison L. Hannah: Thank you, Dean. Moving on to slide 38. H1 of 2026 marked significant progress across each of our strategic priorities. Most notably, we closed the VEPPANU transaction, adding a fourth FDA-approved product to our portfolio and creating an important new long-term growth opportunity. We remain on track for commercial availability in mid-August. Our priorities for H2 of the year are clear. Successfully launch VEPPANU and grow our commercial portfolio. Complete R289 dose expansion enrollment, select the recommended phase II dose, and share top-line data. Evaluate additional indications for R289, and finally, maintain financial discipline while delivering top-line growth and positive net income. With a broader commercial portfolio, a promising pipeline, and a strong financial foundation, we believe Rigel is well-positioned for its next phase of growth and long-term shareholder value creation. We appreciate your time today.

Raul Rodriguez: Thank you, Dean. Moving on to slide 38. H1 of 2026 marked significant progress across each of our strategic priorities. Most notably, we closed the VEPPANU transaction, adding a fourth FDA-approved product to our portfolio and creating an important new long-term growth opportunity. We remain on track for commercial availability in mid-August. Our priorities for H2 of the year are clear. Successfully launch VEPPANU and grow our commercial portfolio. Complete R289 dose expansion enrollment, select the recommended phase II dose, and share top-line data. Evaluate additional indications for R289, and finally, maintain financial discipline while delivering top-line growth and positive net income. With a broader commercial portfolio, a promising pipeline, and a strong financial foundation, we believe Rigel is well-positioned for its next phase of growth and long-term shareholder value creation. We appreciate your time today. With that, I'll turn the call back to the operator for your questions. Operator?

Speaker #3: We've remained on track for commercial availability in mid-August. Our priorities for the second half of the year are clear: successfully launch VEP2 and grow our commercial portfolio, complete R289 dose expansion enrollment, select the recommended phase 2 dose, and share top-line data.

Speaker #3: Evaluate additional indications for R289, and finally, maintain financial discipline. While delivering top-line growth and positive net income. With a broader commercial portfolio, a promising pipeline, and a strong financial foundation, we believe Rigel is well-positioned for its next phase of growth and long-term shareholder value creation.

Speaker #3: We appreciate your time today, and with that, I'll turn the call back to the operator for your questions. Operator.

Alison L. Hannah: With that, I'll turn the call back to the operator for your questions. Operator?

Speaker #1: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Operator 2: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please for the first question. Our first question comes from the line of Joseph Pantginis with H.C. Wainwright. Please proceed with your question.

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please for the first question. Our first question comes from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your question.

Speaker #1: You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys.

Speaker #1: One moment, please, for the first question. Our first question comes from the line of Joe Pangenis, with AC Rainwright. Please proceed with your question.

Speaker #4: Hey, everybody. Good afternoon and thanks for taking the question. So I wanted to go back to one of your comments on the commercial assets that you have here.

Joseph Pantginis: Hey, everybody. Good afternoon, and thanks for taking the question. Wanted to go back to one of your comments on the commercial assets that you have here. Obviously, VEPPANU is, as you said, the largest potential financial opportunity. I wanted to focus on the comment that this would be the lead focus on availability. Obviously you can't have the accelerator pushed, I guess, 100% on all your assets and what's sort of on autopilot, what gives you the confidence to say it will be the lead focus and how that impacts or potentially impacts your efforts on TAVALISSE and REZLIDHIA?

Joe Pantginis: Hey, everybody. Good afternoon, and thanks for taking the question. Wanted to go back to one of your comments on the commercial assets that you have here. Obviously, VEPPANU is, as you said, the largest potential financial opportunity. I wanted to focus on the comment that this would be the lead focus on availability. Obviously you can't have the accelerator pushed, I guess, 100% on all your assets and what's sort of on autopilot, what gives you the confidence to say it will be the lead focus and how that impacts or potentially impacts your efforts on TAVALISSE and REZLIDHIA?

Speaker #4: Obviously, VEP2 is, as you said, the largest potential financial opportunity, but I wanted to focus on the comment that this would be the lead focus on availability.

Speaker #4: So obviously, you can't have the accelerator pushed, I guess, 100% on all your assets, and what's sort of on autopilot, what gives you the confidence to say it will be the lead focus and how that impacts or potentially impacts your efforts on Tavalis and Resilidia?

Speaker #3: Thank you, Joe. I'll ask Dave to comment.

Raul R. Rodriguez: Thank you, Joe. I'll ask Dave to comment.

Raul Rodriguez: Thank you, Joe. I'll ask Dave to comment.

Speaker #5: Yeah, it's a great question, Joe. Over the years, we have gotten very, very good at really understanding what impacts our business, particularly with Tavalis and certainly more recently over the last four years with Resilidia.

David A. Santos: That's a great question, Joe. Over the years, we have gotten very good at really understanding what impacts our business, particularly with TAVALISSE, and certainly more recently over the last four years with REZLIDHIA. With TAVALISSE, I think we understand that market quite well. We know where there are potential new prescribers as well as existing prescribers. I think you have to understand that the majority of that comes from the community, and our team is going to be in those community offices. What I mean by support in terms of TAVALISSE is we're calling on them, bringing a VEPPANU message, and we're making sure that they're completely supported in their desire to prescribe TAVALISSE.

Dave Santos: That's a great question, Joe. Over the years, we have gotten very good at really understanding what impacts our business, particularly with TAVALISSE, and certainly more recently over the last four years with REZLIDHIA. With TAVALISSE, I think we understand that market quite well. We know where there are potential new prescribers as well as existing prescribers. I think you have to understand that the majority of that comes from the community, and our team is going to be in those community offices. What I mean by support in terms of TAVALISSE is we're calling on them, bringing a VEPPANU message, and we're making sure that they're completely supported in their desire to prescribe TAVALISSE.

Speaker #5: With Tavalis, I think we understand that market quite well. We know where there are potential new prescribers as well as existing prescribers. And I think you have to understand that the majority of that comes from the community, and our team is going to be in those community offices.

Speaker #5: So what I mean by support in terms of Tavalis is we're calling on them, bringing a VEP2 message, and we're making sure that they're completely supported in their desire to prescribe Tavalis.

Speaker #5: With Resilidia, one of the things we've really done well, the team has done a lot of work on this, even incorporated AI as well as a lot of looking at diagnostic data, is we've really helped to have the team target potentially when an IDH1 patient occurs, particularly in the community.

David A. Santos: With REZLIDHIA, one of the things we've really done well, the team has done a lot of work on this, even incorporated AI as well as a lot of looking at diagnostic data, is we've really helped to have the team target potentially when an IDH1 patient occurs, particularly in the community. We get a lot of these, what we call them, are alerts for the team, and they can focus on that when the opportunity arises. We don't have to spend a whole bunch of time going around and talking about AML and REZLIDHIA in the community when there's no patients there. That's not what we want to do. We want to selectively find when we think there's going to be an opportunity and present that message, and that'll continue. What we have here is an opportunity to go in, really talk about VEPPANU a lot.

Dave Santos: With REZLIDHIA, one of the things we've really done well, the team has done a lot of work on this, even incorporated AI as well as a lot of looking at diagnostic data, is we've really helped to have the team target potentially when an IDH1 patient occurs, particularly in the community. We get a lot of these, what we call them, are alerts for the team, and they can focus on that when the opportunity arises. We don't have to spend a whole bunch of time going around and talking about AML and REZLIDHIA in the community when there's no patients there. That's not what we want to do. We want to selectively find when we think there's going to be an opportunity and present that message, and that'll continue. What we have here is an opportunity to go in, really talk about VEPPANU a lot.

Speaker #5: We get a lot of these what we call them are alerts for the team, and they can focus on that when the opportunity arises.

Speaker #5: So we don't have to spend a whole bunch of time going around and talking about AML and Resilidia in the community when there's no patients there.

Speaker #5: That's not what we want to do. We want to selectively find when we think there's going to be an opportunity and present that message.

Speaker #5: And that'll continue. So what we have here is an opportunity to go in, really talk about VEP2 a lot. The team has already been doing that, as I said.

David A. Santos: The team has already been doing that, as I said, since close. Actually, what's been interesting is they're getting more access to accounts because of that. That enables them to support TAVALISSE, support REZLIDHIA when there are patients available.

Dave Santos: The team has already been doing that, as I said, since close. Actually, what's been interesting is they're getting more access to accounts because of that. That enables them to support TAVALISSE, support REZLIDHIA when there are patients available.

Speaker #5: Since close. And actually, what's been interesting is they're getting more access to accounts because of that. And that enables them to support Tavalis, support Resilidia when there are patients available.

Speaker #4: That's very, very helpful. I appreciate that color. And then maybe a question for Allison, if you don't mind. And welcome to the full-time position off of the board as well.

Joseph Pantginis: That's very helpful. I appreciate that color. Then maybe a question for Alison, if you don't mind. Welcome to the full-time position off of the board as well. With regard to R289 and the different strategic collaborations, is there one that may or may not be your personal favorite with other hemes or even the glioma indication based on the drug's mechanism of action or other factors that might contribute?

Joe Pantginis: That's very helpful. I appreciate that color. Then maybe a question for Alison, if you don't mind. Welcome to the full-time position off of the board as well. With regard to R289 and the different strategic collaborations, is there one that may or may not be your personal favorite with other hemes or even the glioma indication based on the drug's mechanism of action or other factors that might contribute?

Speaker #4: With regard to R289 and the different strategic collaborations, is there one that may or may not be your personal favorite? With other hemes or even the Glioma indication, based on the drug's mechanism of action or other factors that might contribute?

Speaker #6: So thank you for the question. Is there one favorite when our corporate collaborations? We have the MD Anderson Alliance, which is moving forward very well with multiple clinical trials at this time.

Alison L. Hannah: Thank you for the question. Is there one favorite within our corporate collaborations? We have the MD Anderson alliance, which is moving forward very well with multiple clinical trials at this time. We have the CONNECT study. We have MyeloMATCH. In terms of favorite collaboration, I dare say it would have to be MD Anderson. I have personally worked with the hematological division of MD Anderson for nearly 30 years, so I'm very familiar with all the important scientific collaborations that they can bring. They are attacking hematological malignancies in various different subgroups that I find very attractive, including a maintenance trial, an upfront trial. Honestly, if I had to pick one favorite, it would probably be the MD Anderson collaboration. Thank you for the question.

Alison Hannah: Thank you for the question. Is there one favorite within our corporate collaborations? We have the MD Anderson alliance, which is moving forward very well with multiple clinical trials at this time. We have the CONNECT study. We have MyeloMATCH. In terms of favorite collaboration, I dare say it would have to be MD Anderson. I have personally worked with the hematological division of MD Anderson for nearly 30 years, so I'm very familiar with all the important scientific collaborations that they can bring. They are attacking hematological malignancies in various different subgroups that I find very attractive, including a maintenance trial, an upfront trial. Honestly, if I had to pick one favorite, it would probably be the MD Anderson collaboration. Thank you for the question.

Speaker #6: We have the Connect study, we have Myelomat, but in terms of favorite collaboration, I dare say it would have to be MD Anderson. I have personally worked with the hematological division of MD Anderson for nearly 30 years.

Speaker #6: So I'm very familiar with all the important scientific collaborations that they can bring. And they have they are attacking hematological malignancies in various different subgroups that I find very attractive, including a maintenance trial, an upfront trial.

Speaker #6: So honestly, if I had to pick one favorite, it would probably be the MD Anderson collaboration. But thank you for the question.

Speaker #4: No, I appreciate that. So maybe not favorite because I don't want you to have a favorite trial.

Joseph Pantginis: No, I appreciate that. Maybe not favorite because I don't want you to have a favorite child.

Joe Pantginis: No, I appreciate that. Maybe not favorite because I don't want you to have a favorite child.

Speaker #6: Yeah, no, I feel like I may have gotten into trouble.

Alison L. Hannah: I know. I feel like I may have gotten into trouble.

Alison Hannah: I know. I feel like I may have gotten into trouble.

Joseph Pantginis: I know.

Joe Pantginis: I know.

Raul R. Rodriguez: Joe.

Raul Rodriguez: Joe.

Speaker #4: You have great infrastructure relationships there. So thanks for the question and the answers. Thank you.

Joseph Pantginis: You have great infrastructure relationships there. Thanks for the questions and the answers. Thank you.

Joe Pantginis: You have great infrastructure relationships there. Thanks for the questions and the answers. Thank you.

Speaker #3: Thank you, Joe.

Raul R. Rodriguez: Thank you, Joe.

Raul Rodriguez: Thank you, Joe.

Speaker #1: Thank you. Our next question comes from the line of Farzan Haque with Jefferies. Please proceed with your question.

Operator 2: Thank you. Our next question comes from the line of Farzin Haque with Jefferies. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Farzin Haque with Jefferies. Please proceed with your question.

Speaker #7: Hi. Thank you for taking our questions. Since I'm in on for Farzan a couple of questions from us. First, you increased the upper bound of guidance by 5 million which doesn't include VEP2.

[Analyst] (Jefferies): Hi. Thank you for taking our questions. This is Amin on for Farzin. A couple of questions from us. First, you increased the upper bound of guidance by five million, which doesn't include VEPPANU. The question is, what are you seeing to date for the commercial portfolio that are underpinning this assumption, and what's your expectation for the VEPPANU launch this year?

Amin Makarem: Hi. Thank you for taking our questions. This is Amin on for Farzin. A couple of questions from us. First, you increased the upper bound of guidance by five million, which doesn't include VEPPANU. The question is, what are you seeing to date for the commercial portfolio that are underpinning this assumption, and what's your expectation for the VEPPANU launch this year?

Speaker #7: So the question is, what are you seeing to date for the commercial portfolio that are underpinning this assumption? And what's your expectation for the VEP2 launch this year?

Speaker #3: Well, as Dave and I can comment, by the way, the change to the guidance, before I turn it over to Dave, was we increased the contract revenue from 20 to 30 range to approximately 30.

Raul R. Rodriguez: Well, I'll ask Dave, and I can comment. By the way, the change to the guidance, before I turn it over to Dave, was we increased the contract revenue from $20 to 30 range to approximately $30 as we've seen strong contract revenue come in in H1 of the year. We left intact the product sales rev guidance of $255 to 265. That sales guidance is only on TAVALISSE, GAVRETO, and REZLIDHIA. I'll ask Dave to comment on VEPPANU specifically, but we've maintained our guidance on the other products.

Raul Rodriguez: Well, I'll ask Dave, and I can comment. By the way, the change to the guidance, before I turn it over to Dave, was we increased the contract revenue from $20 to 30 range to approximately $30 as we've seen strong contract revenue come in in H1 of the year. We left intact the product sales rev guidance of $255 to 265. That sales guidance is only on TAVALISSE, GAVRETO, and REZLIDHIA. I'll ask Dave to comment on VEPPANU specifically, but we've maintained our guidance on the other products.

Speaker #3: As we've seen strong contract revenue come in in the first half of the year, we left intact the product sales rev guidance of 255 to 265.

Speaker #3: That sales guidance is only on Tavalis, Gavretto, and Resilidia. So I'll ask Dave to comment on VEP2 specifically, but we've maintained our guidance on the other products.

Speaker #5: Thanks, Raul. Yeah, in terms of guidance for VEP2, we're not going to be issuing any guidance in the short term for VEP2. Obviously, we don't have any sales yet coming in, and you'll see that after third quarter.

David A. Santos: Thanks, Raul. Yeah, in terms of guidance for VEPPANU, we're not going to be issuing any guidance in the short term for VEPPANU. Obviously, we don't have any sales yet coming in, and you'll see that after Q3. We'll update you to give you color and insights into how the VEPPANU launch is progressing. I'll just reiterate that we believe that VEPPANU can become a market-leading treatment in the 2nd-line ESR1-mutated space. We believe we have a product with a differentiated mechanism, and it's a wholly different pharmacologic class, being a heterobifunctional protein degrader.

Dave Santos: Thanks, Raul. Yeah, in terms of guidance for VEPPANU, we're not going to be issuing any guidance in the short term for VEPPANU. Obviously, we don't have any sales yet coming in, and you'll see that after Q3. We'll update you to give you color and insights into how the VEPPANU launch is progressing. I'll just reiterate that we believe that VEPPANU can become a market-leading treatment in the 2nd-line ESR1-mutated space. We believe we have a product with a differentiated mechanism, and it's a wholly different pharmacologic class, being a heterobifunctional protein degrader.

Speaker #5: So we'll update you. As we to give you color and insights into how the VEP2 launch is progressing. But I'll just reiterate that we believe that VEP2 can become a market-leading treatment in this second line ESR1 mutated space.

Speaker #5: We believe we have a product with a differentiated mechanism, and it's a wholly different pharmacologic class being a heterobifunctional protein degrader. And we have the proven efficacy that Allison reviewed and particularly not only a very strong treatment effect in PFS, but also higher response rates both from a partial response rate or overall response rate and a clinical benefit rate, which includes stable disease, which is extremely important in metastatic breast cancer.

David A. Santos: We have the proven efficacy that Alison reviewed, and particularly not only a very strong treatment effect in PFS, but also higher response rates, both from a partial response rate or overall response rate and a clinical benefit rate, which includes stable disease, which is extremely important in metastatic breast cancer. We think we have a tolerable agent. For all these reasons, frankly, even now, I think as we talk to customers, there's a lot of interest in the product. I think the most frequent question we have is, When is the product going to be available? We get this pretty much from all corners of the field. I think we're really looking forward to this product gaining traction in the near future. At some point, we will be issuing guidance on it.

Dave Santos: We have the proven efficacy that Alison reviewed, and particularly not only a very strong treatment effect in PFS, but also higher response rates, both from a partial response rate or overall response rate and a clinical benefit rate, which includes stable disease, which is extremely important in metastatic breast cancer. We think we have a tolerable agent. For all these reasons, frankly, even now, I think as we talk to customers, there's a lot of interest in the product. I think the most frequent question we have is, When is the product going to be available? We get this pretty much from all corners of the field. I think we're really looking forward to this product gaining traction in the near future. At some point, we will be issuing guidance on it.

Speaker #5: And we think we have a tolerable agent. And for all these reasons, frankly, even now, I think as we talk to customers, there's a lot of interest in the product, and I think the most frequent question we have is, when is the product going to be available?

Speaker #5: We get this pretty much from all corners of the field. So I think we've we're really looking forward to this product gaining traction in the near future.

Speaker #5: And at some point, we will be issuing guidance on it.

Speaker #3: We'll have to wait a little bit until we get a few some time under our belts. Farzan, so that we can feel comfortable with the trajectory of the thing is.

Raul R. Rodriguez: We'll have to wait a little bit until we get some time under our belt, Parsa, that we can feel comfortable what the trajectory of the thing is. I have to say, we're excited to see the product in the hands of clinicians and patients in the short order, and then providing some revenue by the end of the year, what we've accomplished this shortened year. It's an exciting driver for us. We're happy with the performance of the other products. They're growing modestly. This, we expect to be the real driver underlying our commercial business.

Raul Rodriguez: We'll have to wait a little bit until we get some time under our belt, Parsa, that we can feel comfortable what the trajectory of the thing is. I have to say, we're excited to see the product in the hands of clinicians and patients in the short order, and then providing some revenue by the end of the year, what we've accomplished this shortened year. It's an exciting driver for us. We're happy with the performance of the other products. They're growing modestly. This, we expect to be the real driver underlying our commercial business.

Speaker #3: But I have to say, we're excited to see the product in the hands of clinicians and patients in the short order. And then providing some revenue by the end of the year, what we've accomplished this shortened year.

Speaker #3: But it's an exciting driver for us. We're happy with the performance of the other products—they're growing modestly. And this, we expect, will be the real driver underlying our commercial business.

Speaker #7: Thanks. That's very helpful. And just one clarification question on VEP2 market opportunity. Can you clarify the 1 billion figure you reference? Does this represent the overall second line ESR1 mutated opportunity to available for oral surge or the this is an estimate specifically for VEP2 potential peak sales?

[Analyst] (Jefferies): Thanks. That's very helpful. Just one clarification question on VEPPANU market opportunity. Can you clarify the $1 billion figure you referenced? Does this represent the overall 2nd-line ESR1-mutated opportunity available for oral SERDs, or this is an estimate specifically for VEPPANU potential peak sales?

Amin Makarem: Thanks. That's very helpful. Just one clarification question on VEPPANU market opportunity. Can you clarify the $1 billion figure you referenced? Does this represent the overall 2nd-line ESR1-mutated opportunity available for oral SERDs, or this is an estimate specifically for VEPPANU potential peak sales?

Speaker #5: That's the market opportunity. We're clear that that's we think that the second line and later ESR1 mutated patient population is about 20,000, which correlates to about a billion dollar market opportunity.

David A. Santos: That's the market opportunity. We think that the second line and later ESR1-mutated patient population is about 20,000, which correlates to about a billion-dollar market opportunity.

Dave Santos: That's the market opportunity. We think that the second line and later ESR1-mutated patient population is about 20,000, which correlates to about a billion-dollar market opportunity.

Speaker #3: And it's higher than that depending on what assumptions you take on pricing, etc.

Raul R. Rodriguez: It's higher than that, depending on what assumptions you take on pricing, et cetera.

Raul Rodriguez: It's higher than that, depending on what assumptions you take on pricing, et cetera.

Speaker #7: Okay. Thanks.

[Analyst] (Jefferies): Okay, thanks.

Amin Makarem: Okay, thanks.

Speaker #3: Thank you, Farzan.

Raul R. Rodriguez: Thank you, Parsa.

Raul Rodriguez: Thank you, Amin.

Speaker #1: Thank you. Our next question comes from the line of Kristen Kluska with Cancer Free Gerald. Please proceed with your question.

Operator 2: Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

Speaker #8: Hi. This is Jenny on Kristen's line. Thank you so much for taking my questions. I have two. While not giving any guidance on VEP2 at this time, realistically, when should we start to model in first sales and what factors should we take into consideration for cadence and penetration?

[Analyst] (Cantor Fitzgerald): Hi. This is Jenny on Kristen's line. Thank you so much for taking my questions. I have two. While not giving any guidance on VEPPANU at this time, realistically, when should we start to model in for sales, and what factors should we take into consideration for cadence and penetration? Second, could you also provide some color on the ongoing studies that Pfizer is conducting, particularly those evaluating VEPPANU in combination regimens?

Jenny Kim: Hi. This is Jenny on Kristen's line. Thank you so much for taking my questions. I have two. While not giving any guidance on VEPPANU at this time, realistically, when should we start to model in for sales, and what factors should we take into consideration for cadence and penetration? Second, could you also provide some color on the ongoing studies that Pfizer is conducting, particularly those evaluating VEPPANU in combination regimens?

Speaker #8: And then, second, could you also provide some color on the ongoing studies that Pfizer is conducting, particularly those evaluating VEP2 in combination regimens?

Speaker #3: Sure. So in terms of the timing, we will be reporting the Q3 sales that we accomplished, but that'll be in November. We'll actually have those.

Raul R. Rodriguez: Sure. In terms of the timing, we will be reporting the Q3 sales that we accomplished, but that'll be in November, we'll actually have those. Now, this will be a shortened quarter, August and then some in September. Again, we'll report a full quarter at the end of the year. At J.P. Morgan, we typically put out a press release before that call, that meeting, saying what our revenues were for the year, in which case we'll include VEPPANU sales for 2024-- sorry, 2025, 2026 in total. That'll be a quarter and about a little bit more than that. At that point, we'll figure out what we're giving in terms of guidance, but we haven't decided that yet. It may not include VEPPANU at the time. On collaborations?

Raul Rodriguez: Sure. In terms of the timing, we will be reporting the Q3 sales that we accomplished, but that'll be in November, we'll actually have those. Now, this will be a shortened quarter, August and then some in September. Again, we'll report a full quarter at the end of the year. At J.P. Morgan, we typically put out a press release before that call, that meeting, saying what our revenues were for the year, in which case we'll include VEPPANU sales for 2024-- sorry, 2025, 2026 in total. That'll be a quarter and about a little bit more than that. At that point, we'll figure out what we're giving in terms of guidance, but we haven't decided that yet. It may not include VEPPANU at the time. On collaborations?

Speaker #3: Now, this will be a shortened quarter. August and then some in September. And then again, we'll report. A full quarter at the end of the year.

Speaker #3: At JP Morgan, we typically put out a press release, but before that call, that meeting, saying what our revenues were for the year in which case we'll include VEP2 sales for 2024 sorry, 2025.

Speaker #3: 26. In total. So that'll be a quarter in about a little bit more than that. And at that point, we'll figure out what we're giving in terms of guidance, what we haven't decided that yet.

Speaker #3: But it may not include VEP2 at that time. On collaborations.

Speaker #8: Certainly. I can provide where we have been in terms of public distribution of data. The Vep2 gastrin plus palbociclib data was initially presented at ESMO Breast Cancer 2024.

Alison L. Hannah: Certainly, I can provide where we have been in terms of public distribution of data. The vepdegestrant plus palbociclib, the data was initially presented at ESMO Breast Cancer 2024. The vepdegestrant plus abemaciclib was presented at ASCO 2026. Finally, the vepdegestrant plus atirmociclib was also presented at that same meeting, ASCO 2026. The data for ribociclib and somoraciclib have not yet been publicly presented, we would anticipate seeing those data in the future, in the not-too-distant future.

Alison Hannah: Certainly, I can provide where we have been in terms of public distribution of data. The vepdegestrant plus palbociclib, the data was initially presented at ESMO Breast Cancer 2024. The vepdegestrant plus abemaciclib was presented at ASCO 2026. Finally, the vepdegestrant plus atirmociclib was also presented at that same meeting, ASCO 2026. The data for ribociclib and somoraciclib have not yet been publicly presented, we would anticipate seeing those data in the future, in the not-too-distant future.

Speaker #8: The VEP2 gastrin plus abemaciclib was presented at ASCO 2026. And finally, the VEP2 gastrin plus atermociclib was also presented at that same meeting, ASCO 2026.

Speaker #8: The data for ribociclib and simoraciclib have not yet been publicly presented, but we would anticipate seeing those data in the future in the not too distant future.

Raul R. Rodriguez: As you know, Kristin.

Raul Rodriguez: As you know, Kristen.

Speaker #8: Thank you so much.

Raul R. Rodriguez: Thank you so much.

Jenny Kim: Thank you so much.

Speaker #3: The importance of this data is that it'll provide context for clinicians using this product in combo. As you probably heard, the product has a tolerability profile that's quite attractive, and therefore may be a good partner in terms of combining with other agents.

Raul R. Rodriguez: The importance of this data is that it'll provide context for clinicians using this product in combo. As you probably heard, the product has a tolerability profile that's quite attractive and therefore may be a good partner in terms of combining with other agents. Thank you, Kristin.

Raul Rodriguez: The importance of this data is that it'll provide context for clinicians using this product in combo. As you probably heard, the product has a tolerability profile that's quite attractive and therefore may be a good partner in terms of combining with other agents. Thank you, Kristin.

Speaker #3: Thank you, Kristen.

Speaker #8: Thank you.

[Analyst] (Cantor Fitzgerald): Thank you.

Jenny Kim: Thank you.

Speaker #1: Thank you. There are no further questions at this time. I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Operator 2: Thank you. There are no further questions at this time. I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Operator: Thank you. There are no further questions at this time. I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Speaker #3: Thank you, everyone, for joining us today. We are pleased with our second quarter performance and really look forward to VEP2 becoming commercially available later this month in the middle of it, as well as several other important milestones with R289 that we are expected to achieve this year.

Raul R. Rodriguez: Thank you everyone for joining us today. We are pleased with our Q2 performance and really look forward to VEPPANU becoming commercially available later this month, in the middle of it, as well as several other important milestones with R289 that we are expected to achieve this year. We appreciate your continued interest and support, and we'll keep you updated throughout the year. Thank you and have a good evening.

Raul Rodriguez: Thank you everyone for joining us today. We are pleased with our Q2 performance and really look forward to VEPPANU becoming commercially available later this month, in the middle of it, as well as several other important milestones with R289 that we are expected to achieve this year. We appreciate your continued interest and support, and we'll keep you updated throughout the year. Thank you and have a good evening.

Speaker #3: We appreciate your continued interest and support, and we'll keep you updated throughout the year. Thank you and have a good evening.

Operator 2: This concludes today's teleconference. You may disconnect your line at this time. Thank you for your participation.

Operator: This concludes today's teleconference. You may disconnect your line at this time. Thank you for your participation.