Offsetting Jakafi LOE and Growth

Q: Can you offset Jakafi loss of exclusivity and continue growth?

A: Yes, our investment in R&D aims to more than compensate for Jakafi's expiration. " We have guidance for peak sales of $3 billion for Jakafi and are well on our way to achieving that. " With 10 launches and 12 new chemical entities in development, each with meaningful potential, our portfolio provides a growth profile that goes beyond Jakafi's patent expiration. "

R&D Investment Strategy

Q: What's your approach to R&D spending and investment levels?

A: We assess each project individually based on financial rationale. " Some programs have been stopped or are ending to make room for new ones. " We're maintaining reasonable R&D spend with improving ratios over the next few years. " Our focus is on prioritizing resources to high-potential programs in the pipeline. "

Tafasitamab Acquisition and Opportunity

Q: What are your thoughts on tafasitamab after acquiring full rights?

A: Acquiring full rights has changed tafasitamab's financial picture " " . We're facing two Phase III studies; positive results could provide significant opportunities " " . While not enormous in size, the brand could increase sales by a few hundred million dollars " " . Tafasitamab's efficacy with low safety cost makes it unique in the market " " .

Pipeline Restructuring and LAG-3 Discontinuation

Q: Can you elaborate on the pipeline restructuring and LAG-3 discontinuation?

A: The restructuring was driven by data review and the progression of our early-stage pipeline. " Retifanlimab data did not impact this decision. " We discontinued LAG-3 programs due to the competitive landscape, as we're behind competitors with established programs. "

Share Repurchase and Capital Allocation

Q: Why did you choose a large share repurchase over acquisitions?

A: The share repurchase reflects our confidence in the business outlook. " We saw a disconnect between the long-term value we see and the stock price, prompting the decision. " Our strong balance sheet allows for both significant repurchases and financial flexibility for business development. " We ended the quarter with $1.5 billion in cash and no debt. "

Key Pipeline Assets for Future

Q: Which pipeline assets will be most important in three years?

A: We are excited about the X2 and X4 antagonists from the Escient acquisition; they are potential first-in-class programs. " The upcoming CDK2 inhibitor data is promising. " Our unique approach with the TGF beta receptor by PD-1 bispecific could be a big differentiator. " Additionally, our mutant CALR and 617 programs aim to change disease outcomes in myeloproliferative neoplasms. "

Jakafi Growth and Competition

Q: What are your expectations for Jakafi's share amidst competitors?

A: Jakafi continues to grow in myelofibrosis; total patients increased by 2% year-over-year. " New patients increased even more. " Competitor drugs are mainly used in the second-line setting. " Growth in polycythemia vera is also strong due to the drug's efficacy. "

Opzelura Growth and Outlook

Q: Can you discuss Opzelura's growth and future expectations?

A: Opzelura's growth is driven by demand. " The current prescription split is 60% atopic dermatitis and 40% vitiligo. " We anticipate further growth with potential pediatric label expansion for ages 12 to 11 years in atopic dermatitis. " We expect the pediatric indication to contribute 10–15% to our total atopic dermatitis business. "

CDK2 Program at ESMO

Q: What should we expect from the CDK2 data at ESMO?

A: We will present data on dose escalation of our CDK2 inhibitor in ovarian cancer at ESMO. " The data supports further development. " We will also provide a development path for the molecule in patients with ovarian cancer. "

ALK2 Inhibitor Data Expectations

Q: What are your expectations for the upcoming ALK2 inhibitor data?

A: Increased dosing has shown increased hepcidin inhibition. " We'll present data at higher doses with more patients. " We're assessing the development path to alleviate anemia from both disease and drug effects. "

MRGPRX4 Antagonist Program

Q: Is Mirum's data a benchmark for your MRGPRX4 antagonist program?

A: Yes, Mirum's data is a reasonable benchmark. " We're excited about our program in primary biliary cholangitis and primary sclerosing cholangitis. " Our X2 and X4 antagonists have shown great safety profiles. " We'll provide an update early next year. "

Combining JAK Inhibitors with PD-1

Q: Any plans to combine JAK inhibitors with PD-1 for oncology?

A: Recent publications suggest potential synergy, but our past clinical experience was not successful. " We currently have no R&D plans but will re-examine the possibility. "

Jakafi XR and CALR/JAK2 Programs

Q: Updates on Jakafi XR and CALR/JAK2 selective programs?

A: Pivotal bioequivalence data for Jakafi XR is expected in early 2025; approval anticipated in 2026. " The CALR and V617F programs are in early stages but hold promise for disease modification. " We may explore new regulatory pathways as these programs represent a new way of viewing the diseases. "

Tafasitamab in Autoimmune Diseases

Q: Thoughts on developing tafasitamab in autoimmune diseases?

A: We're conducting a full evaluation of tafasitamab's potential in autoimmune diseases. " We're aware of the data with CD19-targeted therapies. " We'll provide an update later this year. "