David Amsellem

David Amsellem of Piper Sandler inquired about the contribution from new products in developed markets, the status of inspections at facilities like Nashik, and the planned commercial infrastructure for the upcoming meloxicam launch.

Answer

CFO Doretta Mistras noted that new product revenue is back-half weighted and that delays could impact the total, but this is factored into guidance. CEO Scott Smith reported that remediation at the Indore facility is nearly complete and that the Nashik facility recently received an encouraging product approval. CCO Corinne Le Goff stated that while launch planning for meloxicam is underway, it is too early to detail the specific commercial strategy.

David Amsellem from Piper Sandler questioned the potential for the Indoor facility's issues to impact 2026, the status of another Indian facility inspection, and the company's M&A appetite for development-stage versus commercial assets.

Answer

CEO Scott Smith and CFO Theodora Mistras explained that remediation at the Indoor facility is on track for a mid-year reinspection request and they expect a significant rebound in related products in 2026. They also confirmed the company's business development focus is currently on in-market or very near-to-market assets to build short-term revenue, rather than mid-stage development assets.

David Amsellem asked about Viatris's confidence that quality control issues are contained to the Indore facility, the expected timing for Phase III data from the cenerimod and selatogrel trials, and the company's long-term strategic vision for its business mix and capital deployment.

Answer

CEO Scott Smith stated that of 26 facilities, only the Indore facility has a warning letter, with one other inspection pending classification. Chief R&D Officer Philippe Martin confirmed that data for selatogrel and cenerimod is expected in late 2026, potentially earlier. CEO Scott Smith and CFO Theodora Mistras reiterated the 5-year, 50/50 capital allocation plan between shareholder returns and business development, noting 2025 prioritizes shareholder returns while maintaining strategic flexibility.

David Amsellem of Piper Sandler requested more specific details on the expected new product contributions for 2025, citing a perceived lack of transparency and asking about products like Sandostatin LAR, Victoza, and glucagon. He also asked about the potential competitive dynamics for Symbicort.

Answer

Chief R&D Officer Philippe Martin reiterated confidence in the $450 million to $550 million new product revenue target for next year, confirming that complex products like glucagon, iron sucrose, and liraglutide (Victoza generic) are included in that forecast. Regarding Symbicort, management expressed satisfaction with the performance of their generic, Breyna, and expects it to continue delivering growth into 2025 despite potential new competition.

David Amsellem from Piper Sandler asked about the strong performance of Uplizna following its IgG4-related disease label expansion, inquiring about pent-up demand and the sales opportunity. He also asked about the anticipated rapidity of uptake for the generalized myasthenia gravis (gMG) label expansion, considering the competitive landscape.

Answer

Murdo Gordon, EVP of Global Commercial Operations, noted early but strong uptake for IgG4-related disease, driven by awareness and Uplizna being the only FDA-approved treatment, suggesting a potentially larger market. For gMG, he anticipated a strong presence due to Uplizna's convenient twice-a-year dosing, durable effect, and the market's high switching rates. James Bradner, EVP of Research and Development, attributed differentiation to targeting core disease biology (CD19 positive cells) and highlighted numerically higher efficacy, steroid sparing, and durability.

David Amsellem asked about Uplizna's strong performance following its label expansion in IgG4-related disease, inquiring about any pent-up demand and the refreshed sales opportunity, and also about the anticipated rapidity of uptake for the generalized myasthenia gravis (GMG) label expansion, considering the competitive landscape.

Answer

Murdo Gordon, EVP of Global Commercial Operations, noted that while it's early for the IgG4 launch, the strong uptake is driven by awareness building for a recently defined condition, with significant efficacy (87% flare reduction) and a potentially larger market than initially estimated. For GMG, he anticipates a strong presence due to Uplizna's convenient twice-a-year dosing (after loading), durable effect, and high interest from prescribers in a market where patients frequently switch therapies. James Bradner, EVP of Research and Development, added that Uplizna's differentiation stems from targeting the core disease biology (CD19 positive cells), leading to numerically higher efficacy, more steroid sparing, and superior durability compared to other agents.

David Amsellem asked about Amgen's appetite for significant M&A in the rare disease sector, given the business's strong performance and the company's improving capital structure.

Answer

Robert Bradway, Chairman & CEO, affirmed a continued interest in rare disease M&A but tempered expectations by highlighting the company's current focus on executing its extensive late-stage pipeline and successfully integrating the Horizon acquisition.

David Amsellem of Piper Sandler questioned the lack of significant growth for TEPEZZA despite long-standing commentary about expanding its prescriber base. He asked what is needed for a growth inflection and if a subcutaneous form is a prerequisite.

Answer

Murdo Gordon, EVP of Global Commercial Operations, described the prescriber expansion as a 'progressive evolution' and cited rising 'intent to prescribe' among endocrinologists as a positive leading indicator. He expects growth before a subcutaneous version, which he agreed would accelerate uptake. Peter Griffith, CFO, also reminded that Amgen has owned the asset for only about 1.5 years.

David Amsellem inquired about the growth outlook for former Horizon products, specifically the runway for KRYSTEXXA and the competitive landscape for TEPEZZA.

Answer

Murdo Gordon, EVP of Global Commercial Operations, noted that the ex-Horizon portfolio consists of early-lifecycle products with significant growth potential. He highlighted the robust opportunity for KRYSTEXXA in severe uncontrolled gout and the strategy for TEPEZZA, which includes international expansion and broadening the U.S. prescriber base beyond specialists.

David Amsellem asked for details on VYALEV's uptake and competitive dynamics against ONAPGO, and discussed the sales potential and role of tavapadon in the Parkinson's franchise.

Answer

Jeff Stewart, Executive Vice President, Chief Commercial Officer, highlighted VYALEV's strong global uptake and competitive advantage (80-85% in-play capture) due to 24-hour coverage and reduced need for oral therapies. Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer, detailed VYALEV's benefits over competitors like ONAPGO, including 24-hour control, lower dyskinesia/sedation, and no orthostatic hypotension warnings. He also discussed tavapadon's potential as a once-daily monotherapy or adjunct, differentiating it from generics with superior efficacy and safety profile.

David Amsellem asked about Cabenfi's adoption barriers, specifically inquiring if GI tolerability, twice-daily dosing, or prescriber inertia (due to D2 blocker dominance) are key factors, and what strategies Bristol Myers Squibb plans to implement to increase product acceptance among psychiatrists.

Answer

Chris Boerner, Board Chair and CEO, noted strong positive feedback from physicians and patients once Cabenfi is used. Adam Lenkowsky, Chief Commercialization Officer, acknowledged Cabenfi's progress in an entrenched market with a new mechanism. He identified the primary question from physicians as how to switch from D2s, which is being addressed through robust peer-to-peer activities, real-world data, and an upcoming Phase 4 switch study. He also noted that Cabenfi is tracking ahead of all recently launched D2 analogs in schizophrenia.

David Amsellem asked about the key barriers to COBENFY adoption, such as GI tolerability, twice-daily dosing, or prescriber inertia due to D2 blocker dominance. He sought insights into what the company is hearing and seeing in the field and what strategies are needed to drive greater acceptance among psychiatrists.

Answer

CEO Chris Boerner noted strong positive feedback from physicians and patients once they start using COBENFY. Chief Commercialization Officer Adam Lenkowsky acknowledged the entrenched market and COBENFY's novel mechanism. He identified the primary physician question as how to switch from D2s, which is being addressed through peer-to-peer activities, real-world data, and an upcoming phase IV switch study. He also noted COBENFY is tracking ahead of recently launched D2 analogs.

David Amsellem of Piper Sandler Companies asked about the competitive landscape for KAMZYOS, specifically how BMY will maintain new patient starts if a competitor launches with a potentially less restrictive REMS program.

Answer

EVP & Chief Commercialization Officer Adam Lenkowsky expressed confidence in KAMZYOS, citing its strong real-world data, high efficacy bar, and a recent positive label update that eased monitoring requirements. He stated that BMY sees no meaningful clinical differentiation with the potential competitor and is prepared to maintain market leadership.

David Amsellem inquired about when the INGREZZA commercial organization and DTC spend would be 'right-sized,' and when more aggressive margin expansion associated with the product could be expected.

Answer

Matt Abernethy, Chief Financial Officer, stated that significant margin expansion has occurred over the last five years, with current year projections in the low 40% range. He noted that the company always invests to pull revenue forward and aims for continued leverage in the latter part of the decade, prioritizing maximizing patients on therapy before the 2027-2029 IRA window. Kyle Gano, Chief Executive Officer, added that the TD market is a robust growth engine, with only 10% of 800,000 patients treated, and the prescriber base has increased 30% in two years, justifying the expansion as a step towards future larger psychiatry indications.

David Amsellem asked about the INGREZZA sales force expansion, inquiring when the commercial organization would be 'right-sized' and when DTC (Direct-to-Consumer) spend would be optimized to lead to more aggressive margin expansion.

Answer

Matt Abernethy, Chief Financial Officer, noted significant margin progress over five years and stated the company always invests to pull revenue forward. Kyle Gano, Chief Executive Officer, emphasized the robust growth of the TD market, with only 10% of 800,000 patients treated, and the increasing prescriber base. He explained the current sales organization is right-sized for TD but not larger psychiatry indications, and the expansion sets the stage for future launches.

David Amsellem of Piper Sandler Companies asked how a potentially positive readout for a competitor's muscarinic agonist in Alzheimer's psychosis might influence Neurocrine's development plans for its own M1/M4 agonist, NBI-1117570.

Answer

CMO Sanjay Keswani and Strategic Advisor Eiry Roberts confirmed they are watching the data with interest. They noted that Neurocrine has a robust portfolio of muscarinic agonists with different profiles. While AD psychosis is an important indication, they may choose to advance a different asset than NBI-1117570 for that elderly population, one that could offer a superior safety profile as a direct agonist without needing an 'add-back' therapy.

David Amsellem followed up on CRENESSITY's launch, asking which patient group, adults or pediatrics, was demonstrating greater early traction.

Answer

Chief Commercial Officer Eric Benevich reiterated that while the launch began with an even split, the trend throughout the first quarter shifted towards greater uptake in the pediatric and adolescent patient population, which was consistent with the company's expectations.

David Amsellem asked for more elaboration on the utilization management headwinds for INGREZZA and how they relate to competitor actions with payers.

Answer

Chief Commercial Officer Eric Benevich explained that some health plans tightened their utilization management in the second half of last year, for instance, by periodically changing prior authorization criteria. He noted that Neurocrine has a sophisticated infrastructure to manage this evolving and complex payer environment and that these dynamics are factored into the company's 2025 guidance.

David Amsellem of Piper Sandler inquired about INGREZZA's pricing strategy against AUSTEDO, the potential spillover effects from IRA negotiations, and the company's plans for NBI-568 in indications beyond schizophrenia.

Answer

CFO Matt Abernethy stated that INGREZZA's net revenue per script in 2025 is expected to be very similar to 2024. CCO Eric Benevich added that payer access remains excellent, and the company will monitor the initial IRA negotiation outcomes. The question regarding NBI-568's other indications was deferred.

David Amsellem of Piper Sandler Companies asked about the payer landscape, out-of-pocket patient costs, and the strategy behind the Anafilm cash-pay initiative and copay buy-down programs.

Answer

CEO Daniel Barber explained that payer access challenges are an industry-wide issue. He confirmed a cash-pay program will be available for Anafilm at launch to ensure immediate access and that copay buy-down programs will be a balanced part of the commercial strategy, consistent with industry practice.

David Amsellem of Piper Sandler asked for insights gleaned from the competitor neffy's launch, its effect on market expansion, and the key topics anticipated for a potential FDA Advisory Committee (Ad Comm) meeting for Anaphylm.

Answer

CEO Daniel Barber and executive Sherry Korczynski noted that the epinephrine market is promotionally sensitive and expanding, with Q1 volume up 5%. They view competitor efforts like neffy's DTC campaign as beneficial, stating 'a rising tide rises all boats.' Regarding a potential Ad Comm, Barber reiterated transparency with the FDA, while executive Carl Kraus stated the company is prepared for any questions, highlighting the comprehensive nature of their data set with over 930 dosings.

David Amsellem asked about the likelihood of a commercial partnership for Anaphylm versus a solo launch, any early learnings from the competitor neffy launch, and the company's strategic plans for the Libervant asset.

Answer

CEO Daniel Barber stated that while financial guidance assumes a solo launch for Anaphylm, the company is actively contemplating a partnership if it expands patient reach. Executive Sherry Korczynski noted that the neffy launch is raising awareness for needle-free alternatives and emphasized that payer access is critical. Regarding Libervant, Mr. Barber reaffirmed its value to patients and said its strategic place will be clarified over the next 12-24 months.

David Amsellem of Piper Sandler inquired about Aquestive's preparations for a potential FDA Advisory Committee (ADCOM) meeting for Anaphylm, the planned size and target audience for the initial Anaphylm sales force, and whether the company is now more likely to retain full rights to Libervant for a long-term, broader launch.

Answer

CEO Daniel Barber stated that the company's focus with Libervant is on maximizing value, which includes being ready for a broader launch while remaining open to partnerships. SVP, Chief Commercial Officer Sherry Korczynski detailed the Anaphylm sales force strategy, targeting allergists and high-prescribing physicians with a force of about 100 reps. Chief Medical Officer Carl Kraus noted that while the company will be prepared for an ADCOM, they have worked to de-risk the program by meeting all study endpoints.

David Amsellem posed a long-term question about the evolution of the payer landscape for the growing ACTH category, asking if a more restrictive environment or net price erosion could be expected over time. He also inquired if ANI plans to explore other clinical settings for Cortrophin beyond its current therapeutic verticals.

Answer

President, Director & CEO Nikhil Lalwani stated that ANI has partnered with payers since launching Cortrophin and will continue to engage with them collaboratively. On exploring new indications, he noted that while other areas could be considered in the future, the company's near-term focus is on capturing the significant, untapped opportunity within its current therapeutic areas.

David Amsellem questioned whether the payer landscape for Cortrophin Gel could become more challenging as the category returns to growth. He also asked for management's current perspective on the Alimera acquisition and what has been the most surprising challenge encountered with the ILUVIEN asset.

Answer

President and CEO Nikhil Lalwani expressed confidence in maintaining a collaborative relationship with payers, who he said appreciate the competition ANI introduced to the ACTH category. Regarding the Alimera acquisition, he reaffirmed his strong belief in the asset's long-term value, citing the recent buyout of the ILUVIEN royalty obligation as proof. He emphasized the team's problem-solving capabilities, comparing the current situation to challenges successfully overcome after the Novitium acquisition.

David Amsellem inquired about ANI's capacity for business development and M&A, its tolerance for pro forma net leverage, the long-term vision for the business mix between Brands and Generics, and the specific contribution of the gout indication to Cortrophin's growth.

Answer

Nikhil Lalwani, an executive, explained that ANI's M&A focus is on rare disease, with a disciplined approach to leverage, historically keeping it under 3x. He stated that while both the Rare Disease and Generics businesses are growing, the company's center of gravity will shift towards Rare Disease and Brands. Lalwani confirmed that gout accounts for 15% of Cortrophin's volume and is a key gateway for new prescribers.

David Amsellem of Piper Sandler inquired about the payer landscape for Cortrophin Gel, the sources of its market growth, and the future growth prospects for ANI's generics business in 2025.

Answer

Nikhil Lalwani, an executive at ANI, explained that the company maintains strong payer relationships and anticipates the Medicare out-of-pocket cap will improve patient access. He stated Cortrophin's growth is driven by both overall market expansion and gaining share from competitors, attracting new and existing prescribers. For the generics business, Lalwani expressed confidence in achieving high single-digit to low double-digit growth, supported by a steady cadence of new product launches from its R&D team and U.S. manufacturing footprint.

David Amsellem from Piper Sandler Companies sought clarification on the components of the full-year revenue guidance, specifically asking if it includes AMP-002 and how many launches are assumed. He also asked about the potential market size and competition for AMP-007.

Answer

CFO Bill Peters confirmed the flat revenue guidance includes risk-adjusted contributions from two potential launches this year: AMP-002 and AMP-015. He added that for AMP-007, Amphastar is not aware of any other filers and believes it could be a first-to-market opportunity, representing a potentially significant market.

David Amsellem asked about the outlook for new product launches in 2025 and their potential to offset competitive pressures, and also sought clarity on the commercial support initiatives for BAQSIMI.

Answer

CFO William Peters expressed optimism for near-term approvals of AMP-007, AMP-002, and AMP-015. Executive Dan Dischner confirmed that the company's flat revenue guidance for the year assumes sales from two of these new products. Regarding BAQSIMI, Dischner noted that the sales force has been expanded and a co-promotion agreement with MannKind was added, with a focus on endocrinologists. He also stated that previous distribution issues from the Lilly transition are resolved, reaffirming guidance for high single-digit unit growth for the year.

David Amsellem of Piper Sandler & Co. sought clarification on the informal 2025 guidance, asking which of the three products with GDUFA dates are factored into the two expected launches, if their contributions are risk-adjusted, and if the company could quantify the expected impact from new launches versus declines from competition. He also asked if AMP-002 was one of the four potential approvals.

Answer

CFO William Peters confirmed the guidance includes risk-adjusted contributions from two of the four potential approvals, with sales anticipated to begin in the fourth quarter. He noted that any of the candidates could be approved but the forecast is based on a risk-adjusted view. Regarding AMP-002, he stated that while its approval is possible, it is considered more likely a Q1 2026 event on a risk-adjusted basis.

David Amsellem sought clarity on the expected sales footprint for the generic albuterol HFA in 2025. He also requested updates on the regulatory path for AMP-002 and asked for reasons for confidence in AMP-007's approval, given its GDUFA date extension, and clarification on its product type.

Answer

CFO William Peters stated that while albuterol will have a slow start, it is expected to be a 'meaningful product' in 2025 as capacity increases. Executive Dan Dischner described ongoing FDA discussions for AMP-002 as 'encouraging' and suggested the AMP-007 delay was a non-alarming, procedural matter for a first-cycle review. He clarified AMP-007 is a drug-device combination, not a multi-compound product.

David Amsellem of Piper Sandler asked about the long-term competitive impact of orexin agonists on Avadel's narcolepsy business. He also questioned whether the idiopathic hypersomnia (IH) opportunity would primarily be a switch market or a market expansion play.

Answer

CEO Gregory Divis stated that physician feedback suggests oxybates will remain an important part of narcolepsy treatment, potentially as a complementary therapy to orexins. Regarding IH, Divis emphasized that with only about 11% of the diagnosed population currently treated, Avadel sees a significant "greenfield" opportunity to grow the market rather than just capturing the small number of existing patients.

David Amsellem of Piper Sandler & Co. asked about the potential patient footprint for LUMRYZ in Idiopathic Hypersomnia (IH) compared to its competitor. He also questioned the company's appetite for M&A to diversify beyond being a single-product company.

Answer

CEO Gregory Divis described the IH market as 'highly untapped' and believes LUMRYZ is well-positioned to capture patients from all segments due to its unique once-at-bedtime value proposition. Regarding corporate strategy, Divis stated that Avadel views LUMRYZ as a 'pipeline in a program' with multiple life-cycle opportunities. The top capital allocation priorities are the commercial launch and life-cycle management, though the company remains open to strategic, aligned M&A.

David Amsellem from Piper Sandler asked if the sales organization is facing a tougher environment after capturing initial 'low-hanging fruit,' questioned the team's recent performance, and inquired about the long-term implications of emerging orexin agonists on the oxybate market.

Answer

Executive Gregory Divis expressed pride in the sales force's performance, highlighting their success in expanding reach beyond the initial early adopters. Regarding the competitive landscape, Divis acknowledged the excitement around orexins but emphasized that based on physician research, Avadel believes a significant role for nighttime oxybate therapy will persist. The company's strategy is to position LUMRYZ as the oxybate of choice in that future treatment paradigm.

David Amsellem asked about the patient mix for LUMRYZ between narcolepsy type 1 (NT1) and type 2 (NT2). He also questioned the company's long-term view on the oxybate market's footprint, considering the potential future entry of orexin agonists.

Answer

Executive Richard Kim stated that the LUMRYZ patient mix reflects historical oxybate use, with approximately 70% NT1 and 30% NT2 patients. Regarding orexin agonists, he and Executive Jennifer Gudeman suggested they would likely be used in combination with an oxybate. They believe LUMRYZ is well-positioned due to its ability to address nighttime symptoms and its convenient once-at-bedtime dosing, which avoids sleep disruption.

David Amsellem of Piper Sandler Companies questioned Collegium's business development strategy, asking if the company's self-description as a 'diversified biopharmaceutical company' implies a search for assets outside of its core pain and CNS areas. He also asked whether the focus is squarely on commercial-stage assets versus late-stage pipeline development.

Answer

President and CEO Vikram Karnani clarified that while the company is diversified, its ideal M&A targets would leverage its existing commercial infrastructure in pain and ADHD/psychiatry. He noted that while they are open to other areas, any such move would be approached with extreme financial discipline. Karnani confirmed that the company's primary focus remains on commercial or 'commercial-ready' assets to minimize risk, stating that a move into earlier-stage pipeline assets is not a priority at this time but could be revisited in the future once more scale is achieved.

David Amsellem questioned the company's long-term plans for the size of the Jornay PM sales force, the potential peak sales for the drug, and the scale of a business development transaction Collegium could undertake with its current capital structure.

Answer

Chief Commercial Officer Scott Dreyer responded that the current sales force of 180 representatives is considered the right size for now and will be evaluated annually. President and CEO Vikram Karnani stated that the company is not providing peak sales guidance for Jornay yet, preferring to first assess the impact of the recent sales force expansion. Regarding transaction size, Karnani and CFO Colleen Tupper explained that while no specific size is targeted, the company has the capacity for a meaningful deal. Tupper added that they would consider leveraging up to 3x net debt to EBITDA for the right commercial asset.

David Amsellem inquired about the Journee sales force expansion, asking what portion of prescribers it will cover and if further expansion is contemplated. He also asked how Collegium is planning for the eventual loss of exclusivity for BELBUCA and Nucynta, given the opioid litigation landscape for generic manufacturers.

Answer

CCO Scott Dreyer explained the expanded 180-person sales force will cover 60% of the long-acting ADHD market, targeting approximately 23,000 key prescribers, with no significant further expansion anticipated. CFO Colleen Tupper addressed loss of exclusivity, stating no generic competitor currently has the necessary regulatory, legal, and manufacturing capabilities to launch against their pain products. She confirmed extended exclusivity for Nucynta ER to July 2027 and BELBUCA to January 2027, noting the company will invest through those dates.

David Amsellem of Piper Sandler & Co. focused on Jornay PM, asking for guidance on its expected gross-to-net spread compared to other branded ADHD agents. He also questioned how the diverse commercial call audience for Jornay PM (including pediatricians, GPs, and psychiatrists) would inform the company's future business development and M&A strategy.

Answer

Executive Scott Dreyer noted Jornay PM has strong coverage across 80% of its commercial and Medicaid business. Executive Colleen Tupper specified that Jornay PM's gross-to-net is in the 60s range, which is typical for the branded ADHD market due to rebates and co-pay programs. An executive also explained that Jornay PM's broad call points offer significant flexibility for future business development, allowing the company to leverage its new commercial expertise as it expands beyond pain.

Asked about the competitive headwinds for Zepzelca in second-line small cell lung cancer and when they anticipate a stabilization and return to growth, particularly with the potential label expansion.

Answer

The company acknowledged competitive pressure from Tarlatumab and a smaller second-line patient pool due to improved first-line treatments. They are focused on the potential first-line maintenance approval for Zepzelca (PDUFA on Oct 7), which they believe will be practice-changing, address a larger patient population with a longer duration of therapy, and drive a return to growth.

David Amsellem of Piper Sandler asked about the long-term growth trajectory for Zepzelca, considering competitive pressure from Imdelltra, and whether the planned first-line label expansion would be sufficient to overcome challenges in the second-line setting.

Answer

Renée Galá, President and COO, stated that while Zepzelca remains the market share leader in second-line SCLC, the expansion into first-line maintenance therapy is expected to be practice-changing. This move targets a larger patient population and longer treatment duration, which she believes will return the product to a growth trajectory. Rob Iannone, Head of R&D, added that the competitor is not approved in this setting, positioning Zepzelca to become a new standard of care.

David Amsellem from Piper Sandler asked about the exclusivity runway for Zepzelca, especially with a potential first-line label expansion, and questioned how critical it is for Jazz to have an orexin asset, probing whether the company would pursue other orexin deals if its internal program fails.

Answer

Renée Galá, President and COO, stated that Zepzelca's composition of matter patent extends to December 2029, with additional patent applications pending. Bruce Cozadd, Chairman and CEO, addressed the pipeline strategy, explaining that while the orexin space is of interest, the company's M&A focus is broad, spanning neuroscience, oncology, and rare diseases, and is not dependent on a single mechanism or therapeutic area.

David Amsellem of Piper Sandler questioned Zepzelca's exclusivity runway beyond 2029 and asked how critical it is for Jazz to have an orexin drug if its internal program, JZP-441, does not succeed.

Answer

President & COO Renée Galá confirmed a composition of matter patent for Zepzelca until December 2029, with other applications pending that could extend it. CEO Bruce Cozadd addressed the orexin question by stating that while Jazz is a leader in the sleep space, the company is also actively looking at opportunities across neuroscience, oncology, and rare diseases, and is not limited to a single area.

David Amsellem asked about Zepzelca's exclusivity runway, noting the 2029 patent expiration and 2027 orphan drug exclusivity, and questioned whether the new first-line data could lead to a new period of orphan drug exclusivity (ODE).

Answer

President and COO Renée Galá stated that the company is not in a position to speculate on any potential updates to intellectual property or exclusivity at this time. She emphasized their current focus is on sharing the new data and preparing for submission.

David Amsellem of Piper Sandler inquired about the exclusivity runway for Zepzelca, including patent and orphan drug exclusivity, and whether the new first-line data could lead to an extension.

Answer

President and COO Renée Galá stated that the company is not in a position to speculate on potential updates to intellectual property or exclusivity at this time. She indicated that any relevant changes would be communicated in the future.

David Amsellem of Piper Sandler Companies asked about the upcoming orexin agonist program, seeking clarity on whether the 2026 data would be from healthy volunteers or patients, the timeline for patient studies, and what would be required to validate a 'best-in-class' claim against advanced competitors.

Answer

Chief Medical & Scientific Officer Dr. Kumar Budur clarified the 2026 data will be from healthy volunteer studies to establish a dose range for the highly potent molecule before advancing to patients. He explained that the 'best-in-class' potential is based on high potency, which could enable flexible, low dosing across multiple hypersomnolence disorders with a better safety and tolerability profile.

David Amsellem inquired about the positioning of Harmony's orexin-2 receptor agonist in a crowded market and how the WAKIX payer landscape and gross-to-net might evolve with increased generic competition.

Answer

Dr. Kumar Budur, CMSO, highlighted their orexin agonist's best-in-class potency as a key differentiator in an emerging field. CEO Dr. Jeffrey Dayno and CCO Adam Zaeske confirmed that generic oxybates have not impacted WAKIX's payer coverage, which remains broad and stable due to its unique non-scheduled profile, with payers not requiring step-through therapy.

David Amsellem questioned the 2028 PDUFA assumption for Pitolisant HD, asking about confidence in enrollment timelines given the increasing competition for narcolepsy and IH patients from other clinical trials.

Answer

Dr. Kumar Budur, Chief Medical and Scientific Officer, expressed confidence in the timelines, noting there is less competition for IH patients and that Harmony has established relationships with global clinical trial sites. For narcolepsy, he cited deep investigator relationships and a global trial strategy. CEO Dr. Jeffrey Dayno added that plans to access patients in other global regions will help accelerate the trial.

David Amsellem asked about the payer landscape and net price expectations for 2025 amid generic oxybate competition, and sought clarification on the dosing strategy for pitolisant HD.

Answer

Chief Commercial Officer Jeffrey Dierks expressed confidence in a stable and favorable payer landscape for 2025, citing WAKIX's unique non-scheduled profile and advantageous pricing. CEO Dr. Jeffrey Dayno clarified that while safety for pitolisant HD was established at up to 5x the current max dose of WAKIX, the development program is targeting a dose up to 2x higher, which Chief Medical and Scientific Officer Dr. Kumar Budur noted would yield significantly higher exposure due to an optimized formulation.

David Amsellem from Piper Sandler Companies inquired about the expected trough and growth trajectory for Amneal's Parkinson's franchise following the Rytary patent expiration, and the profitability of the Metsera GLP-1 manufacturing collaboration.

Answer

CFO Tasos Konidaris projected the Parkinson's franchise revenue trough would occur in 2026, with confidence in overcoming any EBITDA headwinds from the Rytary LOE as Krexant sales ramp up. Co-CEO Chirag Patel explained the Metsera partnership will yield higher-than-typical CMO margins due to Amneal's upfront risk and highlighted the significant revenue potential from commercializing in 20 international markets.

David Amsellem inquired about the 2025 revenue outlook for biosimilars, specifically Alymsys, the strategic timeline for achieving vertical integration in the biosimilar business, and the expected revenue contribution from generic injectables.

Answer

Co-CEO Chirag Patel confirmed the biosimilar revenue forecast is on track for approximately $150-$160 million, with Alymsys contributing $90-$100 million. He also stated that Amneal aims to execute on vertical integration plans by late 2025 or early 2026. Co-CEO Chintu Patel added that the injectables strategy balances addressing drug shortages with developing complex products, supported by a strong pipeline and manufacturing capabilities.

David Amsellem sought clarification on the 2028 GLP-1 peptide launch plans, asking if they involve ex-U.S. markets or specific generics. He also questioned how the significant CapEx for new facilities under the Macera collaboration and for biosimilar vertical integration would impact the company's debt paydown strategy and asked about the potential size of M&A.

Answer

Co-CEO Chirag Patel confirmed the GLP-1 strategy includes ex-U.S. markets, potential generics like Trulicity, and contract manufacturing. He characterized the CapEx as manageable, offset by partner contributions and government incentives. For biosimilars, he noted the strategy is to acquire existing capacity via M&A rather than building from scratch. CFO Anastasios Konidaris emphasized that deleveraging remains a top priority and that Amneal is not a 'big M&A shop,' stressing any deal must be strategic, financially sound, and that the company would pursue creative deal structures to maintain its deleveraging path toward a 3x leverage target.

David Amsellem inquired about the launch of CREXONT, specifically its reimbursement landscape and adoption strategy relative to the upcoming loss of exclusivity for Rytary. He also asked for clarity on the revenue mix of the injectable business between shortage products and complex products, and requested an update on the company's intranasal epinephrine product.

Answer

Co-CEO Chirag Patel stated that CREXONT's launch is off to a strong start with good initial payer coverage, and he does not expect Rytary's LOE to have a significant impact as they aim to expand the overall market. Co-CEO Chintu Patel added that the injectable portfolio is well-balanced with complex products and the capacity to address drug shortages. Regarding epinephrine, he noted their current auto-injector is performing well and they see no immediate market impact from competitors.

David Amsellem inquired about Auvelity's line of use mix in MDD and whether the company needs to expand its sales force to better target general practitioners.

Answer

Chief Commercial Officer Ari Maizel reported that early-line usage for Auvelity remains stable at around 50% (second/third line) but is expected to grow with improved access. He stated that the company is comfortable with the current sales force size, as the impact of the recent expansion is already being seen.

David Amsellem from Piper Sandler questioned how Axsome views the commercial opportunity for AXS-14 (esreboxetine) in fibromyalgia, considering the large market size but also the availability of established generics. He also asked about the planned extent of the sales force expansion to support the product.

Answer

Ari Maizel, Chief Commercial Officer, expressed strong enthusiasm for AXS-14, citing the 17 million diagnosed patients in the U.S. He acknowledged the diverse prescriber base and stated that the company is evaluating the optimal sales team structure, which will likely involve a mix of existing personnel and new hires, particularly to target the rheumatology space.

David Amsellem asked about Axsome's philosophical approach to M&A and business development, particularly regarding its willingness to acquire assets that could leverage its existing commercial infrastructure.

Answer

Chief Financial Officer Nick Pizzie responded that while the company is satisfied with its current portfolio, it is always looking for opportunities and has dedicated internal resources to evaluate potential deals. He indicated an openness to assets that could complement the existing pipeline, potentially at an earlier stage.

David Amsellem of Piper Sandler questioned the future trajectory of Axsome's cost structure, specifically R&D spending as studies conclude and SG&A spending with potential new launches for migraine and Alzheimer's agitation.

Answer

CEO Herriot Tabuteau emphasized the company's rational, ROI-focused approach to spending. CFO Nick Pizzie added that the current cash balance is sufficient to reach cash flow positivity and guided for a slight increase in R&D and SG&A in Q4 to support pipeline and pre-launch activities.

David Amsellem of Piper Sandler Companies inquired about Corcept's Korlym business, specifically the authorized generic's (AG) share of business, its pricing discount, and the impact of pharmacy fulfillment issues on prescription pull-through.

Answer

Sean Maduck, President of Corcept Endocrinology, explained that the AG now constitutes about two-thirds of the business with an average 30% discount to Korlym's list price. He detailed that pharmacy capacity issues, despite some improvement, failed to keep pace with surging demand, resulting in a ~$15 million revenue impact in Q2. A second pharmacy is expected to be online in Q4 to alleviate these constraints.

David Amsellem inquired about the expected mix between branded Korlym and its authorized generic (AG) for the rest of the year and whether volume growth would offset the mix shift. He also asked if an FDA Advisory Committee (AdCom) is anticipated for relacorilant in hypercortisolism and when more details on the broader solid tumor strategy would be released.

Answer

Sean Maduck, President of Endocrinology, confirmed that volume growth is expected to overwhelm any price changes from the AG mix, noting over half of patients are already on the AG. Chief Business Officer Charles Robb stated that an AdCom is not expected. Executive William Guyer added that the company will expand into earlier lines of ovarian cancer and other tumors, with more details coming later in the year.

David Amsellem inquired about the expected timeline for the FDA's acceptance of the relacorilant New Drug Application (NDA) and the likelihood of an Advisory Committee (AdCom) meeting. He also asked about the rationale for changing the ROSELLA trial's primary endpoint to a dual primary endpoint and the associated statistical implications.

Answer

CEO Joseph K. Belanoff clarified the trial has dual primary, not co-primary, endpoints. Chief Business Officer Gary Robb stated the FDA has 60 days from the December 30th submission to accept the NDA, the process is proceeding normally, and an AdCom is not expected. Chief Development Officer William Guyer explained the change to dual primary endpoints (PFS and OS) was made in agreement with the FDA and EMA to provide two opportunities for a positive study, detailing the statistical powering and alpha recycling strategy.

David Amsellem of Piper Sandler questioned the interpretation of the GRADIENT trial data, focusing on the lack of statistical significance versus placebo for the primary blood pressure endpoint and its necessity for the relacorilant NDA approval.

Answer

Chief Development Officer William Guyer explained that GRADIENT was always designed as a supportive study to the pivotal GRACE trial, which met its primary endpoint. He emphasized the totality of evidence from four studies, highlighting clinically significant improvements across multiple Cushing's syndrome symptoms in GRADIENT, including blood pressure vs. baseline, glucose control, and weight. Guyer also pointed to the strong safety profile and data from the long-term extension study as key components of a robust NDA package.

David Amsellem from Piper Sandler Companies inquired about Biogen's lupus pipeline, asking for the data timeline for the second Phase 3 daprolizumab trial and the competitive positioning of its assets against potential oral agents.

Answer

Priya Singhal, EVP & Head of Development, stated that data for the second daprolizumab trial is expected in the 2027-2028 timeframe, with litifilumab data anticipated as early as late 2026. CEO Christopher Viehbacher added that orals do not automatically win in immunology, citing the MS market, and emphasized that Biogen's multi-mechanistic approach is well-suited for the heterogeneous nature of lupus.

David Amsellem from Piper Sandler Companies inquired about Biogen's lupus pipeline, asking for the data timeline for the second dapirolizumab Phase 3 study and the company's view on its assets in a crowded field with potential oral agents.

Answer

Priya Singhal, EVP & Head of Development, noted the high unmet need in lupus and detailed Biogen's multi-mechanistic approach. She projected the second dapirolizumab Phase 3 data in 2027-2028 and litifilumab data by late 2026. CEO Christopher Viehbacher added that lupus is highly heterogeneous and that oral therapies are not guaranteed to dominate, citing the MS market as an analogue.

David Amsellem of Piper Sandler Companies inquired about Indivior's strategy for SUBLOCADE, specifically balancing the commercial and Medicaid patient populations, the role of the criminal justice system channel, and future R&D spending priorities.

Answer

CEO Joe Ciaffoni stated that R&D will be reorganized to focus on Phase 2 assets and that the criminal justice system is a stable base for growth. Chief Commercial Officer Patrick Barry added that while Medicaid remains key, the commercial channel is an underpenetrated opportunity, representing 60% of covered lives but only 25% of SUBLOCADE volume, which the company aims to capitalize on.

David Amsellem asked about the expected timeline for SUBLOCADE's return to growth, the competitive landscape, stabilization in the criminal justice system, and potential commercial strategy shifts under new leadership.

Answer

CEO Mark Crossley stated that he would not speak for the incoming CEO but noted SUBLOCADE's growth is expected to accelerate in the second half of the year, driven by marketing initiatives and label enhancements. He highlighted that new patient share has stabilized around 72% for the last three quarters and experienced prescriber share is stable at 65%, indicating the market has adjusted to two primary players. He anticipates the competitive landscape will be more status quo in 2026, focusing on overall category growth.

David Amsellem questioned the competitive dynamics versus funding gaps in the Criminal Justice System (CJS) channel for SUBLOCADE. He also sought clarity on SUBLOCADE's market share of new patient starts against its competitor, Brixadi, and inquired about the long-term pricing outlook for SUBOXONE Film.

Answer

CEO Mark Crossley, CFO Ryan Preblick, and CCO Richard Simkin responded. Crossley addressed SUBOXONE pricing, stating the environment remains constructive. Preblick clarified that CJS challenges are primarily due to budget constraints, not competition, with this impact factored into H1 2025 guidance. Simkin noted that SUBLOCADE's share of new starts is stable at around 71%, and the company's share among experienced dual prescribers is holding at approximately 65%.

David Amsellem asked about the long-term competitive landscape for SUBLOCADE, specifically the expected share of new patient starts, and the company's capital deployment strategy regarding share buybacks versus business development.

Answer

CEO Mark Crossley responded that early data is encouraging, with SUBLOCADE's new patient share above 70% and cohort data stabilizing in the mid-60% range. He emphasized the large unmet market need allows for multiple players. Regarding capital allocation, Crossley stated the priorities are fueling SUBLOCADE growth and advancing the pipeline, with no short-to-medium term plans for business development beyond the current share buyback program.

David Amsellem of Piper Sandler Companies asked about the impact of generic Revlimid on full-year guidance and whether the raised guidance for UZEDY (YOSEDI) could be considered conservative given its strong prescription growth.

Answer

President and CEO Richard Francis clarified that the generics forecast is robust and not solely dependent on Revlimid due to other launches and biosimilar momentum. Regarding UZEDY, he expressed confidence but noted that future growth depends on competing in a broader market against different molecules, which presents a new dynamic.

David Amsellem of Piper Sandler Companies asked if the Phase 3 program would incorporate dosing flexibility to manage adverse events and questioned the commercial importance of having a cataplexy claim on the label for a wakefulness agent.

Answer

Richard Pops, Chairman & CEO, stated that Phase 3 dosing decisions are pending full analysis of Phase 2 data, including NT2 results. He also expressed high confidence that elixorexant will have a cataplexy claim due to a clear clinical signal. Todd Nichols, Chief Commercial Officer, concurred with this assessment.

David Amsellem asked for the company's latest perspective on business development and M&A, including how aggressively it is pursuing assets and the potential size of a transaction it would consider.

Answer

Blair Jackson, COO, confirmed that Alkermes is actively looking to acquire additional assets from Phase I through mid-stage to bolster its neuroscience pipeline. While declining to specify a transaction size, he emphasized that any deal would need to fit the company's strategy and align with its goal of maintaining profitability.

Alex, on behalf of David Amsellem, asked about the potential competitive impact on LYBALVI from a future long-acting injectable (LAI) form of olanzapine and any impact seen from recently launched LAI competitors.

Answer

CCO C. Nichols stated that no impact has been seen from recent LAI launches, attributing LYBALVI's resilience to its broad indication in both schizophrenia and bipolar disorder. Regarding a future olanzapine LAI, he and CEO Richard Pops noted that the key issue for olanzapine has always been weight gain, which LYBALVI addresses, and that LAIs rarely impact the much larger oral market.

David Amsellem asked for the current portion of LYBALVI's business from schizophrenia, the potential impact of a future long-acting injectable (LAI) form of olanzapine, and the company's strategy for in-licensing to bolster the pipeline beyond orexin.

Answer

CCO Todd Nichols stated the LYBALVI prescription mix is about 50-50 between schizophrenia and bipolar, with new starts trending toward bipolar. He believes an olanzapine LAI would not significantly impact LYBALVI, as the core issue of weight gain remains, which LYBALVI addresses. CEO Richard Pops reiterated the company's desire to add non-covariant assets to the pipeline, focusing on areas with well-credentialed biology and complex molecular design.

David Amsellem asked about the peak sales potential for Recorlev given the expanding market for hypercortisolism and whether Xeris anticipates further expansion of its commercial infrastructure to target a wider physician audience.

Answer

CEO John Shannon explained that the sales force expansion in the second half of 2024 is currently driving growth. He stated that more color on Recorlev's peak sales potential will be provided at the upcoming Analyst and Investor Day in June. While the current infrastructure is sufficient, Shannon acknowledged that further expansion would be considered as the market continues to grow.

David Amsellem questioned Xeris's long-term spending strategy for Recorlev in light of competitor investments, asking about potential headcount expansion and promotional spend. He also asked for a reminder of Recorlev's exclusivity runway.

Answer

CEO John Shannon positioned competitor spending as a positive tailwind that raises overall market awareness. Regarding Recorlev's exclusivity, he and CFO Steven Pieper noted patents extending to 2040 and orphan drug exclusivity through the end of 2028. Shannon confirmed that continued investment in Recorlev is a key priority but did not commit to specific headcount expansion plans at this time.

David Amsellem asked about the long-term trajectory and sustainability of Keveyis amidst generic competition. He also questioned how concerned management is about other treatment modalities in the Cushing's space creating competitive noise for Recorlev.

Answer

CEO John Shannon expressed confidence in the durability of Keveyis, citing the value of its patient support services which helps retain and attract new patients despite some pricing pressure. Regarding Cushing's, he views increased activity and awareness from potential competitors as a positive tailwind that helps identify more patients, positioning Recorlev favorably as a best-in-class cortisol inhibitor.

David Amsellem of Piper Sandler asked about the early competitive dynamics for ONAPGO against AbbVie's Vyalev, particularly regarding any physician pushback on using apomorphine. He also inquired about the pipeline asset SPN-443, asking if sleep-wake disorders could be a potential lead indication given its stimulant-like profile.

Answer

Executive Jack Khattar reported an encouraging initial response to ONAPGO with no significant pushback, highlighting the drug's ability to be used as an add-on therapy as a key advantage. He also noted the company's 'Circle of Care' patient support system is a competitive strength. For SPN-443, Khattar confirmed it is being evaluated for ADHD and other CNS indications, with the lead indication to be selected and announced by the end of 2025.

David Amsellem questioned how Supernus views the competitive landscape for Qelbree with the potential entry of new non-stimulants, particularly regarding the impact on volumes and the payer landscape. He also asked for details on ONAPGO's pricing relative to competitors.

Answer

CEO Jack Khattar stated it is too early to comment on competitors without seeing their data and labels, but affirmed Supernus will remain disciplined with payers, leveraging Qelbree's differentiation and market head start. Regarding ONAPGO, he confirmed the price is public and has been set within a competitive range, without providing specific figures.

David Amsellem of Piper Sandler asked about the company's capital deployment strategy, particularly its M&A priorities between commercial and pipeline assets. He also inquired about the long-term competitive landscape for Qelbree and the company's comfort level with pro forma net leverage for a potential transaction.

Answer

Executive Jack Khattar reiterated that the top M&A priority is commercial-stage assets, followed by late-stage pipeline assets, primarily in CNS. Regarding Qelbree competition, he noted they are monitoring developments but need to see full product profiles to assess any impact. On leverage, Khattar stated a comfort level of around 2.5x to 3x EBITDA, depending on the quality and cash flow profile of the acquired assets.

David Amsellem questioned Organon's confidence in achieving its $150 million sales target for VTAMA, focusing on market access and gross-to-net dynamics. He also asked how future business development fits with the new priority of deleveraging.

Answer

CEO Kevin Ali expressed high confidence in the VTAMA target, citing its strong label advantages, positive early feedback, and progress in securing market access. He stated that while deleveraging is the immediate priority, the long-term goal is to strengthen the balance sheet to pursue more accretive, VTAMA-like deals in the future.

David Amsellem questioned Organon's strategy for leveraging its new dermatology infrastructure beyond VTAMA and asked about long-term net leverage targets, noting the ratio has been 'stubbornly high' around 4x.

Answer

CEO Kevin Ali said the immediate focus is on a successful VTAMA launch, with intentions to build out the dermatology portfolio in the future. CFO Matt Walsh reiterated the strategy of deleveraging through EBITDA growth, projecting the net leverage ratio will be 'cleanly below 4x' by the end of 2026 and targeting a mid-3x range long-term.

David Amsellem asked about Organon's long-term strategy for leveraging its new medical dermatology infrastructure for further acquisitions, including potential interest in medical aesthetics, and how the Dermavant deal alters its capital deployment philosophy.

Answer

Chief Executive Officer Kevin Ali responded that while the Dermavant acquisition opens up future opportunities in dermatology, including international expansion for VTAMA, the company's primary focus for 2025 will be on successfully integrating the asset and driving its performance. He noted the strength of the incoming team and Organon's existing access capabilities but deferred specific comments on future M&A strategy.

David Amsellem of Piper Sandler asked about the commitment of Sage's partner, Biogen, to ZURZUVAE and whether its strategic fit within Biogen's portfolio could cause that commitment to wane.

Answer

CEO Barry Greene affirmed that there has been no change in the collaborative relationship with Biogen. He stated that Biogen, like Sage, is very excited by the profound impact ZURZUVAE is having on PPD and the resulting market paradigm shift. While suggesting the question is best posed to Biogen, he noted that all signals from the partnership remain highly encouraging.

An analyst on behalf of David Amsellem asked if the recent corporate restructuring and extended cash runway might constrain the level of commercial support Sage can provide for ZURZUVAE, particularly in relation to Biogen's contribution.

Answer

CEO Barry Greene stated that the company does not feel constrained at all. He reiterated the belief in ZURZUVAE's blockbuster potential and affirmed the strategy to 'scale with success,' meaning they will continue to invest where they believe a dollar spent will result in an immediate improvement in demand and revenue.

David Amsellem asked about the potential for further streamlining the cost structure beyond the recent restructuring, particularly in light of the company's capital structure.

Answer

Executive Greg Martini stated that the company feels good about its 2025 outlook following the recent cost-saving actions. He indicated that while they will continue to evaluate alternatives to prioritize high-value investments, including for the LINZESS brand with AbbVie, there were no further restructuring plans to announce for 2025 at this time.

David Amsellem asked about the potential for fundamentally different payer contracting strategies for LINZESS to improve net economics as it nears the end of its commercial life, and whether spending will decrease to manage the brand for profitability through its LOE.

Answer

CEO Thomas McCourt confirmed that the primary objective is now to increase LINZESS margins and profitability. He stated that all aspects of brand investment, including promotion, market access, and contracting strategies like copay assistance, are being critically evaluated with their partner AbbVie to maximize cash flow.

David Amsellem asked about Ironwood's 2025 contracting strategy for LINZESS to improve net economics, and what specific efficacy signals are needed for the company to move forward with CNP-104.

Answer

Chief Medical Officer Michael Shetzline explained that for CNP-104, the key data point is the T cell response, which they view as a leading indicator of clinical benefit, alongside markers of liver function. Chief Business Officer Andrew Davis addressed the LINZESS strategy, stating that maximizing net economics over the product's life until the loss of exclusivity is the primary focus guiding their future contracting decisions.

David Amsellem asked for additional details on apraglutide's efficacy, specifically regarding statistical separation in the colon-in-continuity (CIC) patient subgroup at earlier time points. He also inquired about the criteria Ironwood needs to see from the CNP-104 trial to justify its continued advancement.

Answer

Chief Medical Officer Michael Shetzline explained that since CIC patients contributed to the primary endpoint, the company has high confidence in approval for the entire patient population. He noted that upcoming DDW data will further bolster confidence in CIC efficacy and highlight a favorable tolerability profile. Regarding CNP-104, Dr. Shetzline stated the company is looking for a demonstrated T-cell response that indicates a reprogramming of pathologic cells, combined with a meaningful clinical improvement in liver function markers.

David Amsellem asked how Pacira is thinking about its cost structure and margin management in the event of a generic EXPAREL launch, and about the potential risk of additional ANDA filers emerging.

Answer

CEO Frank Lee noted that based on industry analogs, a single generic entrant could result in 15-20% price erosion, which Pacira would treat as competition. He reiterated that an at-risk launch is not believed to be imminent. Lee also stated that while the company monitors the competitive landscape, it has not been notified of any new ANDA filings for liposomal bupivacaine.

Inquired about the current off-label use of atypical antipsychotics in Generalized Anxiety Disorder (GAD) and whether the strategy for ITI-1284 is market expansion or share capture.

Answer

There is some off-label use of antipsychotics in GAD, often for patients with comorbid depression. With good clinical data, they believe ITI-1284 can penetrate this large market by addressing the unmet need for patients who fail first-line therapies, effectively expanding the market for approved treatments in GAD for patients with or without comorbid conditions.

Inquired about the bipolar mania program, asking how additive it is to CAPLYTA's sales potential and the primary rationale for pursuing this indication.

Answer

The primary rationale for the bipolar mania program is to fulfill an agreement with the FDA. Completing these studies in adults, along with pediatric PK studies, will satisfy the company's obligations to obtain pediatric exclusivity for CAPLYTA.

David Amsellem pressed on the issue of solvency, asking directly how the company plans to manage approximately $9 billion in debt maturities that coincide with XIFAXAN's loss of exclusivity. He also asked what the company could realistically do to bolster its R&D pipeline through business development given its financial constraints.

Answer

Interim CFO John Barresi highlighted the company's $1.5 billion in liquidity, the ability to monetize a portion of its Bausch & Lomb stake, and the potential for asset sales. CEO Thomas Appio pointed to the RED-C program as a key growth bridge and mentioned ongoing, low-cost business development efforts in the international business and continued investment in the high-growth Solta segment.

Asked about the impact of increasing competition on pricing and practice behavior, specifically whether practices will start limiting the number of products they carry and if outright price competition is expected.

Answer

The company's strategy is to compete on innovation and performance differentiation rather than price. They believe practices will increasingly choose to carry differentiated products. Management feels that significant price competition already exists in the market, but the market has remained resilient due to factors beyond price, such as product quality and services.

Inquired about the portion of the chronic sinusitis market accessible with the current commercial infrastructure, the potential size of that opportunity, and the status of discussions with payers regarding the label expansion.

Answer

The company estimates that about one-third of the total addressable market (10-12 million patients) is cared for by specialists (ENT/allergy) where their current 75 sales territories are deployed. Regarding payers, the executive noted that current contracts generally restrict usage to FDA-approved indications, not specifically nasal polyps, so the new indication should fall within the scope of existing agreements. They also expect the broader diagnosis of chronic sinusitis to improve access.

David Amsellem of Piper Sandler asked about the on-the-ground impact of the Roe v. Wade overturning on Phexxi interest from practitioners and patients, and inquired about the long-term, steady-state outlook for gross-to-net (GTN) margins.

Answer

CEO Saundra Pelletier described a heightened sense of urgency and interest in Phexxi post-ruling, noting increased engagement from healthcare providers and the success of a new educational birth control chart. CFO Jay File addressed GTN, reaffirming the 40% level for 2022 with expectations for it to trend lower. He projected that GTN could reach 35% or even 30% in the near future as new PBM contracts reduce reliance on co-pay programs, which account for nearly half of the current GTN.

David Amsellem from Piper Sandler asked for a refresher on spending priorities, specifically the long-term trajectory of sales and marketing spend, and the steady-state gross-to-net (GTN) percentage once Phexxi achieves broad, no-copay coverage.

Answer

CFO Jay File explained that the primary driver for the $50 million OpEx reduction in 2022 is lower direct-to-consumer (DTC) marketing spend, while R&D costs will decrease significantly as the EVOGUARD trial concludes. He noted sales and marketing spend may increase to support a potential STI indication launch. Regarding GTN, File stated that even in a perfect environment, the best-case scenario would be in the high 20s to 30% range due to distributor costs and other factors.

David Amsellem of Piper Sandler inquired about the risk of major insurance plans failing to provide mandated zero-copay coverage for Phexxi, the timing of this coverage impact, and whether the 2022 sales guidance of $30-$35 million already assumes full compliance. He also asked for clarification on the expected steady-state gross-to-net margin beyond 2022.

Answer

CEO Saundra Pelletier clarified that the 2022 guidance is conservative and does not assume a 'flood gate' of new coverage this year. She identified United and Express Scripts as the primary non-compliant plans but noted the company is successfully using prior authorizations to secure coverage. CFO Jay File added that the target gross-to-net of 35-40% is a goal for the end of 2023, with improvements from the low 70s to the low 60s already being seen in early 2022.

David Amsellem of Piper Sandler questioned the company's long-term viability and potential need for strategic alternatives if it fails to secure its desired ACA coverage status. He also asked if an STI prevention indication would improve payer leverage and what the steady-state gross-to-net margin could be.

Answer

CEO Saundra Pelletier asserted that Evofem can be viable even without a new ACA category by negotiating more favorable contracts (20-30% rebates) directly with payers, driven by demonstrated demand. She confirmed an STI indication would significantly increase leverage with payers. CFO Jay File added that the STI label would help lower gross-to-net, and CEO Saundra Pelletier noted that efforts to lower manufacturing costs would also improve brand equity.

David Amsellem from Piper Sandler inquired about the specific indications VYNE is considering for its BET inhibitors, VYN201 and VYN202, and whether the topical would target mild-to-moderate disease while the oral targets moderate-to-severe. He also asked for the key go/no-go decision criteria for the FMX114 program following its upcoming data release, given the current market for JAK inhibitors.

Answer

Chief Scientific Officer Dr. Iain Stuart explained that FMX114's differentiation lies in its multimodal approach, combining a JAK inhibitor with fingolimod to both reduce inflammation and support skin barrier recovery. President and CEO Dave Domzalski added that the upcoming PK data will be crucial and that the company is bullish on the program. Regarding the BETi platform, Domzalski stated that while it's early, they are exploring rare dermatoses for the topical VYN201 and broader autoimmune conditions like RA or IBD for the oral VYN202, emphasizing that the data will ultimately guide their strategy rather than a pre-set mild vs. severe segmentation.

David Amsellem of Piper Sandler questioned the competitive landscape for the acquired BET inhibitor assets and the strategic thinking behind divesting the minocycline franchise, asking if payer and resource challenges were considered insurmountable even in a post-pandemic environment. He also asked about the future R&D spending trajectory.

Answer

President & CEO Dave Domzalski described the In4Derm partnership as transformational, secured after following the group for some time. Regarding the divestiture, he cited the prolonged 18-month impact of the pandemic and the constraints of time and money for a company of VYNE's scale. CFO Tyler Zeronda clarified that the projected 2022 quarterly OpEx of $10 million already accounts for a Phase 2b trial for FMX114 and advancing the new VYN201 and VYN202 programs into the clinic.

David Amsellem from Piper Sandler inquired about the long-term outlook for gross-to-net pricing for AMZEEQ and ZILXI, particularly considering the current payer landscape and the CVS Caremark decision. He also asked about the company's philosophy on maintaining contracted payer positions despite high gross-to-net demands.

Answer

CFO Andrew Saik stated that for commercially covered lives, the net price per script is expected to be in the $200 to $250 range, but the overall net will be lower due to the need for a cash pay option following the CVS Caremark decision. President and CEO Dave Domzalski added that the company is still assessing the full impact and will maintain a co-pay card program for the time being, while continuously evaluating all distribution and payer partnership options.

David Amsellem asked about the target patient populations for ZILXI and AMZEEQ, specifically where patients are being sourced from, and whether the launch of FCD105 would expand the acne franchise or cannibalize existing products.

Answer

CCO Matthew Wiley explained that ZILXI is expected to draw patients primarily from metronidazole and doxycycline, while AMZEEQ is seeing broad market disruption. CEO David Domzalski added that FCD105 is viewed as a 'game changer' that will be a welcome, disruptive addition to the market, providing physicians with another valuable treatment choice rather than just causing cannibalization.