Leszek Sulewski

Les Sulewski asked for clarification on what drove the significant increase in Cortrophin's guidance since the last update and how ANI outpaced competitor growth. He also inquired about the new product cadence for generics, potential FDA approval delays, and Cortrophin's supply chain capacity.

Answer

President, Director & CEO Nikhil Lalwani attributed the raised guidance to several factors outperforming expectations, including the rapid impact of the sales force expansion, acceleration in new indications, and strong uptake of the prefilled syringe. He reiterated a focus on market growth over market share. Regarding generics, he noted strong R&D execution with no material FDA delays and an expected continued cadence of new launches. He also confirmed that ANI's U.S.-based supply chain is well-positioned to meet the rising demand for Cortrophin.

Leszek Sulewski asked about the trend in naive patient adoption for Cortrophin, the target patient for the prefilled syringe, and its margin impact. He also inquired about the 2025 gross margin outlook, the size of the Medicare Part B patient subset for ILUVIEN, the risk if foundation funding does not return, and whether sales force turnover impacted Cortrophin.

Answer

President and CEO Nikhil Lalwani and CFO Stephen Carey responded. Lalwani noted the naive prescriber base continues to grow and the prefilled syringe is a convenience option with limited near-term margin impact. Carey reiterated the full-year gross margin guidance of 63-64%. Lalwani added that if foundation support for the impacted Medicare Part B patients does not return, ILUVIEN sales would likely trend toward the lower end of its guidance range. He also confirmed the sales force turnover tempered Cortrophin's potential growth but the new team will benefit both products.

Representing Leszek Sulewski of Truist Securities, Jeevan inquired about the key learnings from the Alimera acquisition that could be applied to future M&A, particularly concerning the prevention of delays in closing transactions.

Answer

Executive Nikhil Lalwani outlined two main lessons. First, the importance of adhering to a clear strategy, such as pursuing synergistic acquisitions that expand the rare disease business. Second, the necessity of being prepared to manage unforeseen challenges, citing the YUTIQ supply issue as an example. He expressed confidence in ANI's ability to resolve the issue with its partner EyePoint and highlighted the company's expertise in manufacturing and supply chain management as a key capability in handling such situations.

Les Sulewski of Truist Securities inquired about Collegium's growth strategy for Jornay PM, asking for year-end prescriber targets, current prescriber awareness levels, progress in the adult ADHD market, and whether the company would reconsider its $300-400M peak sales estimate. He also asked a follow-up question about future investment levels for the pain portfolio.

Answer

President and CEO Vikram Karnani stated that the company will reassess Jornay PM's peak sales forecast after evaluating the impact of its expanded sales force and new marketing initiatives. EVP & CCO Scott Dreyer added that while there is no specific prescriber count target, the base grew 23% YoY to 26,000, and they are focused on continued breadth. He noted that the adult segment is growing faster than pediatric, at 33% vs. 21%. Regarding the pain portfolio, Dreyer confirmed that investment levels are stable and consistent, reflecting the franchise's durability.

Leszek Sulewski inquired about the expected trend for Jornay PM prescriptions leading into the summer, the strategy behind the sales force expansion, and the potential to apply Jornay's technology to other compounds. He also asked about the company's appetite for business development in the current market.

Answer

Chief Commercial Officer Scott Dreyer explained the typical seasonality of ADHD medication scripts, with a summer slowdown followed by a back-to-school acceleration. He clarified the sales force expansion aims to increase both reach and frequency with prescribers, with full impact expected in Q4 2025 and beyond. President and CEO Vikram Karnani noted that applying the technology to other compounds was previously explored and found to be most effective for methylphenidate. On business development, Karnani reiterated a disciplined capital deployment strategy, stating the company's strong balance sheet provides capacity for a meaningful deal without being pressured by the market environment.

Leszek Sulewski asked new CEO Vikram Karnani about his 3-to-5-year vision for Collegium, the current stage of business development opportunities, any realized synergies from the Ironshore integration, and the potential impact of the NOPAIN Act on the pain treatment category.

Answer

President and CEO Vikram Karnani outlined a dual growth strategy of organic performance from Journee and inorganic growth via M&A, focusing on commercial assets in neuropsychiatry, CNS, and rare diseases. CFO Colleen Tupper clarified that Ironshore synergies were minimal and related to G&A, as the deal was strategic, not cost-focused. CCO Scott Dreyer stated the NOPAIN Act has no impact on their portfolio as it pertains to inpatient settings, while their products are retail-based.

Leszek Sulewski of Truist Securities inquired about several key areas, including whether the new CEO's rare disease background might alter Collegium's business development strategy, the investment plans for Belbuca leading up to its loss of exclusivity (LOE), and its competitive positioning. He also asked for details on Jornay PM's back-to-school season performance, its peak sales potential, and the seasonality impact.

Answer

Executive Michael Heffernan stated that the immediate strategic focus is integrating Jornay PM and maximizing the pain portfolio, with new CEO Vikram Karnani to refine future business development. Executive Scott Dreyer confirmed Collegium is fully investing in Belbuca through its LOE, viewing emerging pain products as non-competitive in its chronic pain space. Dreyer also highlighted Jornay PM's strong back-to-school performance, with an 18% increase in average weekly prescriptions from July to October, but declined to provide peak sales guidance.

Les Sulewski of Truist Securities asked about the primary drivers of the higher-than-expected clinic attrition, questioning if the adoption of GLP-1s was a contributing factor or if the causes were more internal. He also requested details on the company's longer-term initiatives.

Answer

CEO Bret Christensen responded that the company views GLP-1s as complementary, not a cause of attrition. He attributed the procedure revenue headwinds to two main internal disruptions: the launch of the CDSS software in Q3 2024, which distracted the sales team, and the subsequent organizational restructuring in May 2025. Christensen emphasized that while these actions were necessary for long-term growth, they created short-term slowdowns and the company is still feeling their effects.

Leszek Sulewski asked for clarification on the new sales force realignment, its progress relative to other key initiatives, and the company's potential exposure to tariffs on its supplement business.

Answer

CEO Bret Christensen clarified that the announced realignment is a new initiative focused on growth, not cost-cutting, and effectively increases the field sales team by 25% by converting support roles. He stated the CDSS software rollout is complete. CFO Robert Peterson added that the vertical integration of the Asteria manufacturing facility is in the 'fourth inning' and that the company sees no significant tariff impact due to domestic sourcing and proactive inventory management.

Leszek Sulewski asked for a reconciliation of the 2% to 4% procedural revenue growth guidance for 2025, inquiring about the contribution from new versus existing practitioners. He also sought more detail on the new CEO's three areas of focus and questioned if patient demand was being impacted by the rise of GLP-1s.

Answer

CFO Robert Peterson explained that new customer growth is a material driver but did not provide a specific breakdown, noting that the CDSS software launch temporarily slowed new additions. CEO Bret Christensen detailed his focus on servicing top-tier providers, reigniting new practitioner growth, and improving commercial execution. Both Christensen and Executive Marc Beer stated that GLP-1s are offered as a service via the BioteRx platform, are not core to the business, and they have seen no evidence of them cannibalizing demand for hormone optimization.

Leszek Sulewski asked about the quantifiable impact of hurricanes on clinic closures, competitive pressures from GLP-1 focused clinics, and potential plans to bring BioteRx offerings in-house or pursue M&A. He also inquired about the sustainability of Q3's EBITDA margin.

Answer

CFO Bob Peterson stated that delayed procedures from hurricane-related closures are expected to be recovered in Q4 and early 2025. CEO Teresa Weber asserted that they have not lost patients to GLP-1 clinics and that their offering is competitive. She noted innovation is focused on provider needs, including formulations to help patients transition off GLP-1s. Peterson added that further EBITDA margin expansion in 2025 is possible, contingent on state licensing progress.

Les Sulewski of Truist Securities inquired about the new Johnson & Johnson MedTech partnership for ZILRETTA, its economics, the gross-to-net impact of a new GPO, sales force expansion progress, and the gross margin outlook for the second half of the year and beyond.

Answer

CEO Frank Lee clarified the new J&J partnership is for ZILRETTA and its financial impact is reflected in current guidance. CFO Shawn Cross stated the GPO's gross-to-net impact is a low single-digit percentage and detailed how manufacturing efficiencies led to increased full-year gross margin guidance of 78-80%. CCO Brendan Teehan added that the expanded sales teams are hitting their stride and securing key formulary wins.

Speaking on behalf of Leszek Sulewski, an analyst asked about the potential revenue contribution from ZILRETTA's Phase III study in shoulder osteoarthritis, with data expected in 2026. The analyst also questioned if there were any plans to accelerate development timelines or expand into other indications.

Answer

CEO Frank Lee expressed excitement for ZILRETTA, stating the shoulder indication represents a substantial opportunity in a market with approximately 1 million intra-articular injections annually. He confirmed that if approved, ZILRETTA would be the first long-acting corticosteroid for shoulder pain. Lee stated that the registrational study is enrolling and the company feels good about delivering top-line data in mid-to-late 2026.

Leszek Sulewski asked for an update on receiving a sample of the Avanos generic product, how much of the iovera° treatment cost is covered by the new reimbursement, and the reasons for ZILRETTA's script deterioration.

Answer

CEO Frank Lee confirmed Pacira has not received a generic sample and does not see a launch as imminent. He stated the new $255 iovera° reimbursement significantly improves the value proposition on top of an approximate $450 out-of-pocket cost. For ZILRETTA, Lee acknowledged it has been a lower priority but believes the product is promotionally responsive and expects future growth from new marketing and promotional strategies.

Les Sulewski from Truist Securities asked for an update on the Rytary generic launch, Krexant reimbursement status, international regulatory timelines for Krexant, and the company's long-term gross margin outlook beyond 2027.

Answer

CFO Tasos Konidaris noted Teva's generic Rytary is not yet approved and stated Amneal is not in the business of diluting margins, expecting them to increase steadily over time. SVP & Chief Commercial Officer - Specialty, Joe Renda, reported Krexant commercial coverage is over 60%, exceeding expectations. Co-CEO Chintu Patel projected Krexant launches in Europe by late 2026 and India in late 2026 to early 2027.

Leszek Sulewski asked about AvKARE's exposure to federal government budget cuts, any observed FDA delays in approvals or site visits, and the timeline for establishing ex-U.S. partnerships for CREXONT, particularly in India.

Answer

Co-CEO Chirag Patel clarified that federal cuts do not apply to pharmaceuticals and that Amneal sees volume growth in government channels. He also confirmed no FDA delays. Regarding CREXONT, partnerships are secured for Canada, Latin America, and Europe, with a new deal for Southeast Asia, while Amneal will self-market in India. Co-CEO Chintu Patel added that all product goal dates remain on track.

Leszek Sulewski asked for an update on naloxone, specifically regarding any new state contracts. He also requested commentary on the long-term opportunity for Unithroid and asked if the company has a new deleveraging target for 2025, given its faster-than-anticipated progress.

Answer

Co-CEO Chirag Patel stated that while the state-level process for naloxone is slow, Amneal has a significant contract with California and is working through distributors, expecting to supply about 2.5 million kits in the coming year. He described Unithroid as a stable product with a consistent growth profile. CFO Anastasios Konidaris addressed deleveraging, confirming they will continue to pay down debt and are targeting a net debt to EBITDA ratio of 3.6% to 3.7% by the end of 2025, with a gross debt reduction target of $80 million to $100 million.

Leszek Sulewski's questions centered on the GLP-1 partnership with Metsera. He asked if the deal has raised awareness of Amneal's manufacturing capabilities, leading to new partnership inquiries. He also requested details on current versus future sterile injectable capacity, how that capacity will be allocated, the potential path to enter the generic GLP-1 market, and the expected competitive response.

Answer

Co-CEO Chirag Patel confirmed that the Metsera deal has attracted attention from other large companies. He detailed plans to significantly increase peptide API and finished product capacity over the next three years. Patel outlined a clear strategy to leverage this capacity to become a key global supplier for both branded GLP-1s and future generics upon loss of exclusivity, noting the uniqueness of their co-development partnership model.

Les Sulewski of Truist Securities inquired about the sustainability of the second-half EBITDA margin uptick, potential for cost savings beyond the $700M target, and the company's capital allocation priorities, including buybacks and M&A.

Answer

President and CEO Richard Francis linked the strong EBITDA to the growing high-margin innovative portfolio and described cost savings as a continuous modernization effort. EVP & CFO Eli Kalif projected second-half EBITDA would be above the midpoint of guidance, driven by innovative product growth and transformation savings. He noted that while shareholder returns are reviewed, the immediate focus is on reaching leverage targets and fueling growth.

Leszek Sulewski asked about Vafseo inventory stocking trends, specifically whether a large initial order is expected from LDOs, and requested an overview of the market opportunity for the non-dialysis (NDD) label expansion.

Answer

CCO Nicholas Grund stated that inventory is within the normal 2-4 week range and he does not expect a 'giant stocking' from LDOs. Instead, they will stock for their initial pilots and adjust based on observed demand. CEO John Butler detailed the NDD opportunity, highlighting strong physician interest and a market of ~550,000 patients. He noted the revenue potential is significantly higher than in dialysis, with an estimated net price per patient over $10,000 annually due to the Part D reimbursement model.

Leszek Sulewski asked about the normalization of orders from U.S. Renal Care, the current patient penetration rate, and the ability to differentiate utilization from inventory build-up. He also questioned the strategy for negotiating with Medicare Advantage plans during the TDAPA period.

Answer

CEO Joseph Todisco estimated that U.S. Renal Care is over 80% implemented within its eligible patient population, with growth expected from new patients and other mid-sized customers. He confirmed good visibility into utilization versus inventory. Regarding reimbursement, he stated the plan is to negotiate with Medicare Advantage plans while TDAPA is active, using data from the real-world evidence study, and noted that MA plans already account for a promising 40% of claims.

Leszek Sulewski from Truist Securities requested specific Q3 metrics like patient count or vial usage, the current utilization rate within the 60% of clinics with access, and the strategy to capture the remaining 40% of operators. He also asked about the timeline for meaningful inpatient revenue contribution and the payout details for the triggered MD Partners license agreement.

Answer

CEO Joseph Todisco stated the company is not providing patient or unit metrics at this time but may revisit this. He clarified the 60% access is potential availability and utilization varies, representing significant upside. The strategy for the remaining 40% involves re-engaging a major LDO. He positioned inpatient revenue as a long-term contributor. CFO Matt David added that the MD Partners milestone was met in Q3, the liability is accrued, and payment is expected over the coming year.

Leszek Sulewski asked about the progress of conversations with large dialysis operators, any hesitation on adoption, and the weekly progression of the $5.2 million in sales. He also questioned how the new clinical studies would be funded and the expected timeline for the TPN study enrollment and data.

Answer

CEO Joseph Todisco reported being in late-stage negotiations with a top dialysis provider, while noting some others are taking a 'wait-and-see' approach. He described the sales progression as consistent. Todisco also stated that the company can fund its clinical programs with cash on hand, operating cash flow, and its ATM facility, avoiding large dilutive financing. EVP Elizabeth Masson-Hurlburt added that the TPN study will begin enrollment after FDA feedback, with no planned interim analysis before 2027-2028.

Leszek Sulewski inquired about updates on potential tariffs, the specific drivers of the $150 million reduction in operating cash flow guidance, and the expected cadence for EBITDA margins throughout 2025.

Answer

CEO Thomas Appio stated that the tariff situation is fluid, with the primary impact on the Solta business in China, but short-term effects are mitigated by in-country inventory. CFO JJ Charhon added that overall exposure is limited and has been integrated into the maintained guidance. He clarified the cash flow guidance change is driven by higher interest expenses from the refinancing and associated transaction costs. For EBITDA phasing, he advised using 2024's quarterly performance as a proxy for 2025.

Leszek Sulewski inquired about the status of the Norwich lawsuit regarding Xifaxan, the potential for an at-risk launch, the rationale for discontinuing the amiselimod Crohn's disease study, and requested more details on recent international cardiometabolic business development deals.

Answer

CEO Thomas Appio stated that Bausch Health believes the FDA is correct in its determination that Teva remains the first filer for a Xifaxan generic and has not forfeited its status. Regarding amiselimod, he explained the company determined the investment in Crohn's disease was not worthwhile given the performance of similar drugs. Appio also detailed that the international deals, including one with MSN, are for a broad portfolio of branded generics aimed at building a franchise to drive growth in Latin America and other regions for years to come.

Leszek Sulewski asked for timelines on rulings in the XIFAXAN patent lawsuits against Norwich and Amneal. He also inquired about the drivers of weakness in RELISTOR sales and whether lenders were pressuring the company to halt the Bausch & Lomb separation.

Answer

CEO Thomas Appio stated the Norwich ANDA is barred until 2029, with an expected generic entry in 2028, and noted new patents are in dispute. He attributed RELISTOR's weakness to payer coverage and gross-to-net pressures. He declined to comment on discussions with lenders, citing company policy.