Malcolm Hoffman

Malcolm Hoffman, on behalf of Evan Seigerman from BMO Capital Markets, asked about the most appealing oncology indications for ABCL635 in BMS studies, beyond breast and prostate cancer, and whether equivalent efficacy with a differentiated profile would suffice compared to agents like Linzess and Veozah.

Answer

Sarah Noonberg, Chief Medical Officer of AbCellera, confirmed interest in breast cancer patients on aromatase inhibitors/tamoxifen and prostate cancer patients on ADT. She emphasized that even with equivalent efficacy, ABCL635 offers significant differentiation through its safety profile (lack of liver signal, no liver monitoring required) and convenience of once-monthly dosing. She also noted potential for improved efficacy from deeper and more sustained target engagement as an upside.

Malcolm Hoffman asked about the most promising oncology-based VMS indications for ABCL635, beyond breast and prostate cancer, and whether the drug needs to demonstrate superior efficacy compared to existing agents like Elinzanetant or if a differentiated safety and dosing profile would be sufficient given the limited non-hormonal treatment options.

Answer

Sarah Noonberg, Chief Medical Officer, confirmed interest in breast cancer patients on aromatase inhibitors/tamoxifen and prostate cancer patients on ADT. She emphasized that even with equivalent efficacy, ABCL635's differentiated safety profile (absence of liver signal, no liver monitoring) and once-monthly dosing would be significant differentiators, while improved efficacy from deeper target engagement is considered an upside.

Malcolm Hoffman asked about the perceived stagnation in partner-initiated programs progressing clinically, inquiring if it's a timing issue, and also sought insight into the strategic timing and unique contributions of Dr. Sarah Nunberg's appointment as Chief Medical Officer.

Answer

Carl Hansen, AbCellera's President and CEO, explained that partner programs often take longer than initially anticipated to reach clinical development, sometimes up to six years, but are expected to accrue value over time. Regarding Dr. Nunberg, Mr. Hansen noted her appointment aligns with AbCellera's 2023 strategic shift to internal drug development, the maturation of their pipeline, and the company's ability to attract top-tier clinical development talent.

Malcolm Hoffman of BMO Capital Markets inquired about the key efficacy data and specific biomarkers from the ABCL635 Phase I study that would provide confidence for further development.

Answer

CEO Carl Hansen explained that early biomarker data will include LH and FSH. However, he emphasized that the true measure of efficacy will come from the proof-of-concept (POC) portion of the study, which will assess the frequency and severity of vasomotor symptoms, with data expected in mid-2026.

Malcolm Hoffman of BMO Capital Markets, on for Evan Seigerman, requested more context on the paused development of four NovaRock molecules and its implications. He also asked if AbCellera is considering U.S.-based manufacturing redundancies to mitigate risks associated with its Canadian facilities.

Answer

President and CEO Dr. Carl L. Hansen clarified that the pause in NovaRock's programs is believed to be related to fundraising efforts, a common challenge in the current environment. Regarding manufacturing, Dr. Hansen explained the Canadian facility is built to support Phase I and II trials, and moving products to the U.S. for trials is not expected to be an issue. He noted that considerations for commercial manufacturing locations are a topic for the distant future.

Malcolm Hoffman of BMO Capital Markets asked about the initial preparations for the upcoming CTA filings for ABCL575 and ABCL635, and if there were any notable nuances between a CTA and a U.S. IND filing process.

Answer

CEO Carl L. Hansen responded that IND-enabling studies began over 18 months ago and that extensive work has been done to prepare the clinical teams and plans. He confirmed that both programs have progressed smoothly, all necessary preparations are in place, and there are no particularly noteworthy considerations at this stage. He expressed confidence in the team and the plan to execute.

Malcolm Hoffman asked about the dynamics contributing to Opdualag's particularly strong U.S. growth in Q4, including physician engagement efforts. He also sought to contextualize the remaining growth potential for Reblozyl in the MDS anemia indication, given its high penetration.

Answer

Adam Lenkowsky, Executive Vice President and Chief Commercial Officer, stated that Opdualag is a standard of care in first-line metastatic melanoma in the U.S., approaching 30% market share, with BMS's total share over 65%. He identified opportunities to source business from PD-1 monotherapy patients and international launches (Australia, U.K., France), plus an all-comers indication in Europe. For Reblozyl, he noted strong growth, annualizing over $2 billion, with continued demand in first-line RS positive and significant growth opportunity in RS negative patients in the U.S., and new launches/reimbursements ex-U.S.

Malcolm Hoffman asked about the dynamics contributing to Opdualag's particularly strong U.S. growth in Q4, including physician engagement efforts. He also sought to contextualize the remaining room for growth for Reblozyl in the MDS anemia indication, given its high penetration.

Answer

Adam Lenkowsky (Executive Vice President and Chief Commercial Officer, Bristol Myers Squibb) stated that Opdualag is a standard of care in first-line metastatic melanoma in the U.S., with over 30% market share and BMS's total share exceeding 65%. He identified opportunities to convert patients still on PD-1 monotherapy and highlighted international launches and an all-comers indication in Europe (Q2) as growth drivers. For Reblozyl, he noted continued strong growth, annualizing over $2 billion, with significant opportunity in RS negative patients in the U.S. and international launches/reimbursement in first-line settings ex-U.S.

Malcolm Hoffman asked for quantification of how much of the updated revenue guidance reflects a stronger quarter for COVID-19 vaccines versus contributions from the BMS collaboration and UK government agreements, and if there were any minor changes on the COVID front.

Answer

Uğur Şahin, Chief Executive Officer and Co-founder, explained that the COMIRNATY (COVID-19 vaccine) business is performing within expectations with stable market share and pricing, assuming lower volumes, and is on track to close the year in line with outlook. He clarified that the updated revenue guidance mainly reflects the BMS collaboration, with $700 million recognized in Q3 2025 as part of the total $3.5 billion expected between 2025-2028, to be recognized in broadly equal amounts over the next three years.

Malcolm Hoffman, on behalf of Herbert Desta, asked for quantification of how much the updated revenue guidance reflects a stronger quarter for COVID-19 vaccines versus updates from the BMS collaboration and UK government agreements, seeking clarity on the relative contributions.

Answer

Uğur Şahin, Chief Executive Officer and Co-founder, stated that COMIRNATY maintains a stable position with strong market share and pricing, performing within expectations despite assumed lower volumes. He clarified that the updated revenue guidance primarily reflects the BMS collaboration, which will contribute $3.5 billion in upfront and non-contingent payments between 2025 and 2028, recognized broadly equally over the next three years.

Malcolm Hoffman, on for Evan Seigerman, noted the improvement in Daybue's 12-month-plus patient persistence (from 65% to 70%) and asked for further explanation, questioning if it was related to provider comfort in managing the product's profile.

Answer

Chief Commercial Officer Thomas Garner attributed the improvement to several factors, including better education of the patient community, caregivers, and HCPs on how to utilize the product. He noted that the user base is becoming more comfortable with titration and that learnings from COEs are being amplified into the community, all reinforced by the new customer model.

Malcolm Hoffman of BMO Capital Markets asked about the drivers that could push NUPLAZID's full-year gross-to-net percentage toward the high or low end of its 22.5% to 25.5% guidance range.

Answer

CFO Mark Schneyer explained that the primary factor influencing the gross-to-net percentage is patient payer mix, which can fluctuate quarterly and is outside the company's control. He also mentioned that any future pricing actions would be another variable affecting the final figure.

Malcolm Hoffman, on for Evan Seigerman, asked for Scholar Rock's thoughts on the recent sales rebound for Spinraza and how that might affect long-term market dynamics for apitegromab as a combination therapy.

Answer

CEO David Hallal emphasized that the SAPPHIRE trial demonstrated apitegromab's benefit regardless of the background SMN therapy. He stated that Scholar Rock will monitor the dynamics of the entire SMN market but is confident in its position to help all patients, including those on Zolgensma, which will be further explored in the upcoming OPAL study.

Malcolm Hoffman, on behalf of Evan Seigerman, asked about the potential impact of proposed U.S. tariffs and the company's overall exposure to China.

Answer

CFO Geoffrey Porges confirmed that revenue from China is minimal, substantially less than 5%, and does not pose a significant risk. He further contextualized the company's low geopolitical risk by noting that exposure to the NIH and total U.S. government funding is also very low (less than 1%), insulating the business from potential volatility in U.S. academic research funding.