Alex Hammond

Alex Hammond from Wolfe Research inquired about Amgen's strategy to maintain Pavblu's leadership position in the biosimilar market as new competitors are expected to launch in the second half of the year, and sought clarification on growth expectations.

Answer

Murdo Gordon, EVP of Global Commercial Operations, stated that Amgen has established strong inroads with national retina specialist networks for Pavblu, emphasizing the product's device and the reliability of Amgen's manufacturing. He expressed confidence in competing effectively against both the innovator and future entrants, leveraging Amgen's extensive biosimilar experience. Robert Bradway, CEO, reiterated that product-specific guidance would not be provided.

Alex Hammond asked about Amgen's strategy to maintain Pavblu's leadership position amidst the launch of other biosimilars in the second half of the year and sought clarity on growth expectations.

Answer

Murdo Gordon, EVP of Global Commercial Operations, highlighted Pavblu's strong inroads with national retina specialist networks, its effective competition against the innovator, and confidence in competing effectively with future biosimilar entrants, leveraging Amgen's extensive biosimilar experience and the product's ready-to-use prefilled syringe format.

Alex Hammond asked about the expected update for the Lyme disease vaccine VALOR study, including launch expectations if positive, vaccine contracting models, key target channels, and the potential market size opportunity.

Answer

Chief Scientific Officer Chris Boshoff stated that the phase III VALOR trial for the first-in-class Lyme disease vaccine is expected to read out in the first half of this year. He highlighted the significant unmet need, with approximately 400,000 people affected in the U.S. and 132,000 in Europe, and the potential for a very important vaccine in specific regions.

Alex Hammond from Wolfe Research, LLC asked about the expected update timeframe for the Lyme disease vaccine VALOR study, launch expectations if positive, details on vaccine contracting and key target channels, and the overall market opportunity size.

Answer

Dr. Chris Boshoff, Chief Scientific Officer, Pfizer, stated that the Phase 3 VALOR trial for the first-in-class multivalent protein subunit vaccine for Lyme disease is expected to read out in the first half of this year. He highlighted the significant number of people affected by Lyme disease in the U.S. (400,000) and Europe (132,000), and the potential for a very important vaccine in affected regions due to long-term morbidity and sequelae.

Alex Hammond sought more details on the delay in initiating the pivotal trial for the adult 25-valent pneumococcal program, specifically asking if the dialogue with the FDA had changed and if surrogate endpoints might no longer be approvable.

Answer

Chris Boshoff, Chief Scientific Officer and President of Research and Development, explained that Pfizer is working closely with the FDA and other regulators on study designs and endpoints. He stated that the adult and pediatric 25-valent programs are planned to start next year, pending positive data and FDA feedback, to align and coordinate the studies. He highlighted the vaccine's enhanced immunogenicity against serotype 3 and mentioned ongoing work on a fifth-generation vaccine.

Alex Hammond inquired about the reason for the delay in initiating the pivotal trial for the adult 25-valent pneumococcal program, specifically asking if the dialogue with the FDA has changed or if surrogate endpoints might no longer be approvable.

Answer

Chris Boshoff, Chief Scientific Officer and President of Research and Development, Pfizer, explained that Pfizer is working closely with the FDA and other regulators on study designs and endpoints. The plan is to align the start of the adult 25-valent program with the pediatric 25-valent program in 2026, pending positive fourth-dose data from the pediatric study and regulatory feedback. He highlighted the vaccine's potential for enhanced immunogenicity against serotype 3. Albert Bourla, Chairman and CEO, Pfizer, also contributed.

Alex Hammond questioned the intellectual property runway for Keytruda, specifically the discrepancy between the consensus 2028 U.S. LOE and Merck's SEC filings suggesting patents expiring in 2029, and how to model QLEX's ramp prior to IV biosimilar introduction.

Answer

Rob Davis, Chairman and CEO, clarified that while the compound patent expires in December 2028, two other patents (method of making and method of use) extend to May and November 2029, respectively. He noted growing confidence in defending these patents but maintained a conservative planning assumption of 2028 due to the IRA impact in 2029. He reiterated the goal of 30-40% QLEX adoption by 2028, with pricing strategy aimed at driving this conversion.

Alex Hammond asked for clarification on Keytruda's intellectual property (IP) runway, specifically how to model the expiration given SEC filings suggest patents extending to 2029, and how to think about the ramp-up of Keytruda QLEX prior to IV biosimilar introduction.

Answer

Rob Davis, Chairman and CEO, Merck & Co. Inc, explained that while the compound patent expires in December 2028, two other patents (method of making and method of use) extend to May and November 2029, respectively, with growing confidence in their defense. For planning, Merck conservatively assumes 2028 due to the IRA. He expects 30-40% adoption of Keytruda QLEX by 2028, with a strategy to maximize adoption regardless of the exact LOE date.

Alex Hammond asked about the importance of the upcoming ATTAIN-MAINTAIN trial to orforglipron's commercial opportunity and if its outcome could significantly alter the view on orforglipron's launch scale.

Answer

Kenneth Custer, President, Lilly Cardiometabolic Health, described ATTAIN-MAINTAIN as a first-of-its-kind study, expressing hope that orforglipron will enable patients to maintain weight loss after switching from injectables. He believes it will further expand the market and provide valuable medical information for physicians.

Alex Hammond inquired about the strategic rationale behind the timing of the orthopedic business separation and whether similar divestitures are anticipated for other divisions. He also asked how the separation might impact Johnson & Johnson's long-term financial guidance.

Answer

Chairman and CEO Joaquin Duato explained that the orthopedic separation aligns with J&J's strategy to prioritize high-growth markets and breakthrough innovation, positioning the standalone DePuy Synthes for greater success. CFO Joe Wolk clarified that this separation is not a precursor for other divisions and that 2026 guidance will likely still include the orthopedics business, with material updates expected mid-next year.

Alex Hammond asked about the rationale and timing for the orthopedic spin-out, whether similar separations could be expected in the future, and how the separation might impact Johnson & Johnson's long-term guidance and potential forecast revisions.

Answer

Chairman and CEO Joaquin Duato explained the orthopedic separation as a strategic move to prioritize breakthrough innovation in high-growth markets, while creating a standalone champion in orthopedics (DePuy Synthes). CFO Joe Wolk clarified that this separation is not a precursor to other divestitures and that 2026 guidance would likely still include the orthopedics business, with material updates expected mid-next year.

Alex Hammond from Sidoti & Company, LLC followed up on the 2026 biofragrance commercial ramp, asking if it stems from expanding with the current client or adding new customers. He also requested a comparison of the potential royalty scale for nonallergenic crops and nitrogen use efficiency relative to rice.

Answer

Interim CEO Peter Beethen confirmed the 2026 ramp is focused on a single customer, with potential for future expansion. Regarding royalties, he explained that while productivity traits are priced on farm-gate savings, quality traits like nonallergenic crops could command a considerably higher premium, though no specific figures were provided.

An analyst on behalf of Alex Hammond asked about the expected dynamics of patient switching following potential competitor launches for VOXZOGO, and how these dynamics might differ by geography and patient age.

Answer

Chief Commercial Officer Cristin Hubbard stated that competition is factored into their models and believes VOXZOGO will have significant 'stickiness.' She cited the trust built from positive patient and physician experiences, a strong safety profile with over 6,000 patient-years of data, and high compliance rates (~95%) as high barriers to switching. She also highlighted BioMarin's entrenched global footprint as a key strategic advantage.