Michael Nedelcovych

Michael Nedelcovych inquired about the FDA's draft guidance on biosimilars, specifically its potential to limit comparative efficacy studies, and how Organon interprets this policy's impact on its business, including future margins. He also asked for details on Nexplanon's contribution to 2026 sales guidance and if the 5-year label will be accretive.

Answer

Joe Morrissey, Organon's Interim CEO, indicated the biosimilar guidance would have an incremental impact, supporting their existing partnership strategy. Matt Walsh, Organon's CFO, projected Nexplanon sales to be roughly flat year-on-year in 2026, with ex-US growth offsetting US reinsertion headwinds, while expressing optimism for long-term growth from the 5-year label.

Michael Nedelcovych from TD Cowen asked for elaboration on the federal funding headwinds affecting Nexplanon in the U.S. and whether the sales decline was due to purchase timing or persistent underlying pressures. He also questioned how capital allocation priorities might shift after leverage targets are met.

Answer

Kevin Ali, CEO & Board Member of Organon, explained the Nexplanon headwinds are a combination of factors, including nervousness around Planned Parenthood and Medicaid funding. He expressed confidence in achieving growth for the year, citing strong ex-U.S. performance and the upcoming five-year indication launch. Regarding capital allocation, he stated the current focus remains on deleveraging to below a 3.5x ratio before discussing future priorities.

Michael Nedelcovych inquired about the future of Organon's business development, asking about the potential size and frequency of deals. He also sought clarity on the strategic scope of 'women's health' and which therapeutic areas might be considered out of bounds.

Answer

CEO Kevin Ali explained that Organon's definition of women's health is broad, covering conditions unique to women, those that disproportionately affect them, and areas where women are primary caregivers. He emphasized that the immediate focus is on deleveraging, which will create future capacity for deals of various sizes, prioritizing assets where Organon can be a better owner.

Michael Nedelcovych inquired about the status of any Paragraph IV filings for NEXPLANON and the likelihood of a generic competitor before 2030. He also asked if the current portfolio is sufficient to accelerate growth post-2026 without further M&A.

Answer

CEO Kevin Ali confirmed that no Paragraph IV filing for NEXPLANON has been received and sees a low risk of a generic competitor before 2030, citing patent protection on the applicator and exclusivity for the potential 5-year indication. He also stated that while the company will continue to pursue business development, he is confident the existing portfolio can drive accelerated top- and bottom-line growth from 2026 through 2030.

Mike Nedelcovych (TD Cowen) asked if it is a settled matter that Entyvio Pen will be included in the IRA price negotiation, or if there's a chance of its exclusion. He also inquired about the partnered AC Immune Alzheimer's asset, specifically if mid-year data would trigger Takeda's opt-in decision, and sought Andy Plump's broader thoughts on Alzheimer's disease prevention via early amyloid plaque clearance.

Answer

Julie Kim (CEO-elect) confirmed that Takeda expects the Entyvio Pen to be included in the IRA negotiation. Andrew Plump (President, R&D) clarified that data for the AC Immune program to drive an opt-in decision would come in subsequent years, not this year. He expressed strong belief in the potential for greater benefits from early A beta plaque clearance compared to passive antibodies, highlighting excitement for the vaccine program despite historical challenges in balancing safety and efficacy.

Mike Nedelcovych asked if Entyvio Pen's inclusion in IRA price negotiations is a settled matter and if there's any chance of its exclusion. He also inquired about the anticipated data readout and opt-in decision for the partnered AC Immune Alzheimer's asset, and Andy Plump's general thoughts on early amyloid plaque clearance for AD prevention.

Answer

CEO-elect Julie Kim confirmed that Takeda expects Entyvio Pen to be included in the IRA negotiation. President of R&D Andrew Plump clarified that data for the AC Immune program to drive a decision will come in subsequent years, not this year. He expressed strong belief in the potential of early A beta plaque clearance for greater benefits in Alzheimer's disease, highlighting the challenge of balancing safety and efficacy in vaccine programs.

Asked about the adoption hurdles for the Entyvio pen and the competitive threat from a new subcutaneous IL-23. Also questioned the design of the zazocitinib head-to-head trial (superiority vs. non-inferiority) and its impact on peak sales projections.

Answer

The company is resolving local-level access issues for the Entyvio pen, which should drive growth. For zazocitinib, they confirmed the head-to-head trial is powered for superiority, which they believe is key to establishing it as a new, more effective oral standard of care and significantly expanding the oral treatment market in psoriasis.

Michael Nedelcovych of TD Cowen asked for the definition of success for the upcoming zasocitinib Phase III psoriasis data, specifically regarding the PASI 75 and PASI 100 endpoints. He also inquired about the trial's timing and whether Takeda had unblinded data in-house.

Answer

Executive Andrew Plump confirmed Takeda remains blinded to the data to maintain trial integrity until the 52-week and 60-week readouts. He noted that while PASI 75 is the primary endpoint, the company is most enthusiastic about demonstrating a clear advantage on PASI 100. CEO Christophe Weber added the goal is to redefine the oral psoriasis segment with biologic-level efficacy.

Michael Nedelcovych of Cowen asked about the competitive positioning of Takeda's TYK2 inhibitor, TAK-279, in IBD following a competitor's trial failure. He also inquired whether the reiteration of full-year guidance was overly cautious, given the better-than-expected performance of VYVANSE and other key products.

Answer

Andrew Plump, President of R&D, suggested the competitor's data was actually encouraging for TAK-279, noting Takeda is using higher, more optimal doses, and expressed continued confidence in its potential. CFO Milano Furuta explained that guidance was maintained because VYVANSE erosion is expected to accelerate and R&D spending is weighted towards the latter half of the year.

Michael Nedelcovych of Cowen and Company inquired if Takeda's high-dose strategy for its TYK2 inhibitor, TAK-279, is validated by a competitor's recent trial failure in IBD. He also asked if the reiteration of full-year guidance was intentionally cautious given strong Q1 results.

Answer

R&D President Andy Plump suggested the competitor data was encouraging for TAK-279, as it showed positive effects even at lower doses. CFO Milano Furuta clarified that the guidance was maintained not out of caution, but because VYVANSE erosion is expected to accelerate and R&D spending is weighted towards the latter half of the year.

Michael Nedelcovych of TD Cowen asked about the hurdles for Entyvio pen adoption in the U.S. and the competitive threat from a rival's subcutaneous offering. He also questioned if the zazocitinib head-to-head trial is powered for superiority and the impact on its peak sales ambition if it is not.

Answer

U.S. Business Unit President Julie Kim explained that Entyvio pen adoption challenges are being addressed at a local level to resolve system and coverage pull-through issues, expressing confidence in continued growth. R&D President Andrew Plump confirmed the zazocitinib vs. ducravacitinib trial is powered for superiority. President and CEO Christophe Weber added that demonstrating superiority is key to establishing a new standard for oral psoriasis treatments and expanding the oral market share.

Questioned the strength of the oncology segment, asking which asset deserves more attention, and inquired about the growth trajectory for the Qdenga vaccine towards its peak sales target, specifically whether it would be linear or occur in large steps.

Answer

Takeda acknowledges it is not yet a leader in oncology but is committed, highlighting mid-stage assets like subasumstat and T-cell engagers. For Qdenga, growth will be a combination of linear uptake in private markets and non-linear jumps from large government contracts for national immunization programs. The peak sales target is tied to expanding manufacturing capacity to 100 million doses annually to meet high demand.

Mike Nedelcovych asked two questions: first, regarding the LP(a) space, if the Horizon trial fails in 2026, to what extent could differences in trial design potentially salvage pelacarsen's prospects in 2027; second, concerning obexelimab, whether the very interesting phase II MS data, reported after Royalty Pharma's deal announcement, changed their thinking on peak potential or if MS upside was already factored in.

Answer

Marshall Urist, EVP Head of Research and Investments, acknowledged that if Novartis's Horizon trial is not positive, differences in trial design and LP(a) lowering depth could differentiate pelacarsen's outcome, but it's hard to comment specifically without details. For obexelimab, he confirmed the MS data was great and validated the B-cell modulating mechanism, but the near-term funding focus for the deal was on IgG4-related disease, which drives the immediate capital need, implying MS upside was not the primary driver of the initial deal valuation. Pablo Legorreta, CEO and Chairman, directed the question to Marshall Urist.

Mike Nedelcovych asked about the LP(a) space, specifically if differences in trial design could salvage pelacarsen's prospects in 2027 if Novartis's Horizon trial fails in 2026. He also inquired if the interesting phase 2 MS data for obexelimab, released after Royalty Pharma's deal announcement, changed their thinking on its peak potential or if MS upside was already considered.

Answer

Marshall Urist, EVP and Head of Research and Investments, stated that if Novartis's Horizon trial fails, differences in trial design and depth of LP(a) lowering could differentiate pelacarsen's outcome, but specific comments are difficult without more details. For obexelimab, he confirmed the MS data validates the mechanism of action, but the near-term funding focus was on IgG4-related disease, which drives the immediate capital need, and MS upside was not the primary driver of the deal.

Michael Nedelcovych of TD Cowen followed up on the Vertex dispute timing, asking if 2026 is a worst-case scenario, and inquired about the aficamten market opportunity in light of Camzyos's performance.

Answer

CEO Pablo Legorreta stated the 2026 timeline for the Vertex dispute resolution is a conservative estimate and it could be resolved sooner. Head of Research & Investments Marshall Urist noted that Camzyos's success confirms the large market opportunity for aficamten, which he believes can differentiate on ease of use and its developing data set.

Michael Nedelcovych from TD Cowen asked if pharmaceutical companies could use accounting methods to offset tariffs that might affect royalties, whether NIH funding uncertainty creates opportunities for Royalty Pharma, and why larger pharma companies are not pursuing the Tourette's drug ecopipam.

Answer

EVP, CFO Terrance Coyne stated it was too early to speculate on pharma's response to tariffs but expects minimal impact on Royalty Pharma. Founder & CEO Pablo Legorreta noted that the capital needs of the biotech sector create a significant opportunity for their synthetic royalty business. EVP Marshall Urist explained that the ecopipam investment showcases their ability to identify underappreciated markets through proprietary analysis.

Michael Nedelcovych questioned if the 2025 top-line guidance could be considered conservative, given the company's history of outperforming initial forecasts. He also asked about the most common reasons for declining a potential transaction during the extensive screening process.

Answer

EVP and CFO Terrance Coyne acknowledged the history of outperformance but noted the guidance range is wider as it is early in the year, while expressing confidence in the portfolio's momentum. EVP, Head of Research and Investments Marshall Urist explained that the disciplined screening process filters opportunities based on a broad set of factors, including development stage, intellectual property strength, and clinical profile. CEO Pablo Legorreta added that this broad review provides valuable ecosystem insights.

Michael Nedelcovych posed two questions: first, regarding expectations for a competitor's (emraclidine) upcoming readout and whether it's viewed as a threat or a 'rising tide' for Covency; and second, about the assumptions for Tremfya's uptake in ulcerative colitis (UC), particularly in frontline versus later-line settings.

Answer

Marshall Urist, EVP, Head of Research and Investments, answered both. On Covency, he explained that competition was assumed in their base case and that having multiple companies developing the market is a positive. For Tremfya, he stated that with Janssen's strong marketing capabilities, they see IBD as a significant future growth driver for the product and a meaningful opportunity for Royalty Pharma, regardless of the specific line of therapy.

Michael Nedelcovych sought clarification on the specific differentiation of Medcera's agents (MET 97, MET 233) from Novo Nordisk's internal pipeline candidates, beyond just once-monthly dosing, and whether public data supports this conclusion. He also asked if Novo Nordisk would cancel its CTAD presentation for the Evoke trials if the results for early Alzheimer's disease were unequivocally negative.

Answer

EVP of Research and Development and CSO Martin Lange reiterated that Medcera's pipeline offers complementarity across efficacy, safety, tolerability, scalability, and dose/frequency, making it an attractive proposition. He clarified that Novo Nordisk does not have internal knowledge of the Evoke trial data and would issue a corporate announcement if they did. He confirmed the company's intention to present whatever data they have at CTAD in early December, regardless of the outcome.

Michael Nedelcovych followed up on Medcera, asking Martin Lange to articulate the specific differentiation of Medcera's agents from Novo Nordisk's internal pipeline candidates (CagriSema, amycretin) beyond once-monthly dosing, and whether this conclusion was based on public or non-public data. He also asked if Novo Nordisk would cancel its CTAD presentation for the Evoke trials if the results were unequivocally negative.

Answer

EVP of Research and Development and CSO, Martin Holst Lange, stated that Novo Nordisk looks for complementarity in efficacy, safety, tolerability, scalability, and dose/frequency, seeing differentiation across multiple parameters for Medcera's assets. He clarified that no one in the room had internal knowledge of the Evoke trial data, and if they did, a corporate announcement would be required. He confirmed the company's intention to present whatever data they have at CTAD in early December, regardless of the outcome.

Michael Nedelcovych of TD Cowen inquired about the impact of Wegovy's exclusive formulary position with CVS and the company's legal strategy to combat the illicit compounding of GLP-1 medications in the U.S.

Answer

David Moore, EVP of U.S. Operations, stated that the CVS formulary conversion is proceeding as planned but declined to provide specific figures. On compounding, Moore emphasized it is a patient safety priority, noting that compounding is largely illegal and that no legal actions are off the table, highlighting increased dialogue with the FDA.

Inquired about potential political risk, specifically whether the U.S. administration might use IRA negotiations to demand a severe price cut for GLP-1s. He also asked for an update on the pipeline, questioning if the Phase III obesity trial for amycretin could start in 2025 and which formulation would be prioritized.

Answer

The company sees limited additional political risk from IRA negotiations, as Wegovy has low Medicare exposure and Ozempic is already part of an established negotiation process. Regarding amycretin, the Phase III program is planned to start in Q1 2026, pending regulatory feedback, and will include both oral and injectable formulations.

Michael Nedelcovych asked about the potential political risk of the U.S. administration using IRA negotiations to demand severe price cuts for GLP-1s. He also inquired about the timeline for the amycretin Phase III obesity trial start.

Answer

CEO Lars Fruergaard Jørgensen stated he sees limited additional risk, as Wegovy has low Medicare exposure and Ozempic is already subject to the established IRA negotiation process. Martin Holst Lange, EVP and Head of Development, clarified that the Phase III program for amycretin is expected to begin in Q1 2026 and will include both oral and injectable formulations.

Michael Nedelcovych from TD Cowen asked about the competitive landscape for the anti-CCR8 program, specifically seeking information on any competitor data that could serve as proof of concept, and also inquired about potential competitors for the anti-IL-27 program.

Answer

Chief Scientific & Development Officer Theresa Lavallee stated that Coherus is not aware of any other anti-IL-27 antagonists in clinical development. Regarding the anti-CCR8 program, she highlighted compelling data from competitors in pancreatic and colorectal cancers as validation for the mechanism. CEO Dennis Lanfear added that he anticipates more data from competitors will become public over the next 6 to 12 months, further validating the class.

Inquired about the competitive landscape for the anti-CCR8 program, specifically asking about any competitor data that could serve as proof of concept, and also asked if there are any other anti-IL-27 molecules in development.

Answer

The company is not aware of any other anti-IL-27 antagonists in clinical development. For the CCR8 class, they see growing validation from competitors' data in various tumors (e.g., pancreatic, colorectal cancer), which they find compelling. They expect more data from competitors in the next year.

Michael Nedelcovych of TD Cowen asked if the time needed to gain LOQTORZI market share implies significant off-label use of other PD-1s. He also inquired about the CCR8 competitive landscape and whether any other molecules have helped validate the therapeutic mechanism.

Answer

Chief Scientific and Development Officer Dr. Theresa Lavallee addressed the CCR8 landscape, noting that while CHS-114 is uniquely selective, competitor data, such as from INOVIO Medicine's LM108, has provided exciting proof of concept for the class. Executive Vice President, Commercial, Sameer Goregaoker, confirmed that off-label use of KEYTRUDA and chemo-only regimens persists due to habit, but their strong data and NCCN guidelines are effectively changing physician behavior over time.

Michael Nedelcovych of TD Cowen questioned the company's confidence in the Direct Corp asset, larsucostol, given its Phase 2b primary endpoint miss. He also asked about the risk of off-label generic Rifaximin use competing with the new SSD formulation and whether a head-to-head trial was considered.

Answer

CEO Thomas Appio conveyed confidence in the larsucostol asset, describing the Phase 2b endpoint miss as "very slight" and emphasizing the company's deep expertise in hepatology. He confirmed the plan for a single Phase 3 trial. Regarding the SSD formulation, he stated it is a different product with a different dosage and that no head-to-head trials against original XIFAXAN are planned.

Michael Nedelcovych questioned the resilience of Bausch Health's business segments in a potential recession, the commercial risk posed by potential off-label Xifaxan use to the RED-C launch, and the manufacturing location for Xifaxan supplied to the U.S.

Answer

CEO Thomas Appio asserted that the business is highly resilient to a recession, citing the essential nature of its pharmaceutical products and the economic stability of Solta's consumer base. Regarding RED-C, he emphasized it is a different drug from Xifaxan and serves a vast global patient population, representing a significant opportunity. CFO JJ Charhon clarified that Xifaxan's API originates in Italy and is manufactured in Canada, making it an Italian import for U.S. customs.

Michael Nedelcovych inquired about the portion of Xifaxan sales derived from Medicare and the potential for IRA-negotiated pricing to spread to private channels. He also asked for quantification of the plan to access capital markets by pledging Bausch + Lomb shares.

Answer

CEO Thomas Appio declined to provide a specific percentage for Medicare sales, noting it's early in the IRA process and the focus is on demonstrating Xifaxan's value. CFO JJ Charhon did not provide a specific quantum for the debt raise but reinforced that the goal is to address as much of the upcoming maturities as possible, considering cash on hand and the company's strong cash flow generation of over $1 billion per year.

Michael Nedelcovych asked about the company's 'Plan B' should the full separation of Bausch & Lomb prove unfeasible. He also questioned the commercial assumptions justifying the costly Phase III program for amiselimod, given it would be a third-to-market product in its class.

Answer

CEO Thomas Appio declined to outline a 'Plan B,' restating that the separation remains a strategic priority. Regarding amiselimod, he explained the plan to target a moderate-to-severe UC population, where data could be stronger, and noted that variable treatment responses in the large IBD market indicate a significant unmet need, justifying the investment.

Michael Nedelcovych from TD Cowen requested an update on Novartis's cardiovascular pipeline, particularly its goal of having multiple arrhythmia assets in the clinic by 2025.

Answer

CEO Vasant Narasimhan confirmed the company is on track, with a novel agent for atrial fibrillation expected to enter the clinic in 2025. He added that one or two additional assets are expected to follow shortly after, reinforcing the company's commitment to building a portfolio in this area of high unmet need.

Michael Nedelcovych questioned the potential for on-target, off-tumor toxicity for the DLL3 program, specifically in organs other than the kidney. He also asked about the company's partnering strategy for the Switch-DARPin platform, inquiring if they favor molecule-specific or broad platform deals.

Answer

Chief Medical Officer Philippe Legenne stated that DLL3 is a very 'clean' target, with only minimal expression in the pituitary gland, which has not been a safety concern in other DLL3-targeted programs. CEO Patrick Amstutz explained their partnering strategy is dual-pronged, pursuing both opportunistic, candidate-specific deals and larger, strategic platform collaborations with major pharmaceutical companies.

Michael Nedelcovych questioned if there are any on-target, off-tumor DLL3-expressing organs of concern for radiotherapy and asked about the company's partnering strategy for its unique Switch-DARPin platform.

Answer

Philippe Legenne, Chief Medical Officer, responded that DLL3 is a very clean target with minimal expression outside of tumors, noting only the pituitary gland has minor levels, which has not posed a safety issue in other DLL3-targeting programs. CEO Patrick Amstutz addressed partnering, stating the company is pursuing a dual strategy: engaging in both candidate-specific deals for partners with a defined need and broader, platform-based collaborations with large pharma seeking to build long-term pipelines.