Raghuram Selvaraju • H.C. Wainwright & Co.

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CCO Madhav Vasanthavada explained that revenue is recognized in full only after the patient is treated. He noted that hospitals secure financial agreements with payers before ordering the product, minimizing risk. He also confirmed that payers have not required patients to fail other therapies, attributing this to the strong clinical value proposition of ZivaSkin, which is resonating well with them.

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CEO Vishwas Seshadri explained that the FDA typically indicates acceptance of a resubmission within two weeks and would likely set a six-month PDUFA date for what they anticipate will be a Type 2 resubmission. Regarding strategy, Seshadri outlined several potential growth avenues, including pz-cel life cycle management, leveraging their cell therapy platform in other diseases, and advancing their AAV ophthalmology assets, while stressing the immediate priority is the pz-cel launch.

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CEO Hadar Levy outlined a strategic goal to sign at least five new financing agreements by the end of 2025 and ten more in 2026, with investment sizes ranging from $2 million to $5 million per deal. He highlighted the success of the Stella MSO collaboration, noting it has led to a more than 50% increase in TMS patient utilization at Stella's clinics, a model Brainsway intends to replicate with future partners.

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CCO David Lin explained that post-J code in 2026, the company will expand its focus from 2,000 early adopters to the full universe of 8,500 healthcare providers. He noted it's too early to see a spillover effect on Jelmyto but expects the increased market presence to support its growth. CMO Mark Schoenberg clarified that UGN-103's new formulation addresses solubility and is not expected to change the clinical, safety, or tolerability profile.

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Chief Medical Officer Dr. Mark Schoenberg acknowledged the FDA likely wants a public discussion on the novel approach and confirmed they will use JELMYTO's history to familiarize the committee with the treatment concept. CEO Liz Barrett added this is crucial as the panel is mostly medical oncologists. Regarding UGN-103, she stated enrollment is nearly complete and will finish by the end of summer, with data expected in 2026.

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CFO Chris Degnan addressed the gross-to-net question, stating UGN-102 is not expected to be subject to the Medicare wastes provision and will have less 340B exposure. CCO David Lin noted the prelaunch timeline is not significantly altered. CMO Dr. Mark Schoenberg anticipated a typical AdCom panel of urologists, oncologists, and biostatisticians. CEO Liz Barrett did not have an update on the patent timing.

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CEO Gregory Divis noted the different patient profiles but highlighted the significant overlap in prescribers. COO Susan Rodriguez added that the value proposition of LUMRYZ's extended-release profile, which drives narcolepsy adoption, is also highly valuable for IH patients. Regarding orexins, Divis stated they are awaiting more data but reiterated that physician feedback consistently points to a continued, important role for oxybates.

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David Meeker, Chairman, President & CEO, clarified that the main CMC challenge for Bivamelagon was solved by achieving a 90% drug load, allowing 600mg in a single pill, making smaller pills for lower doses technically straightforward. He stated the auto-injector development for RM-718 is entirely focused on a weekly formulation, with no current plans to explore less frequent dosing.

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Jennifer Chien, Head of North America, highlighted that the HO launch will be more targeted as a vast majority of patients are already under the care of endocrinologists. David Meeker, CEO, added that Rhythm is pleased to have the rights to China back. He noted that while the genetic opportunity is smaller there, the HO opportunity is significant. The company is still developing its China strategy, which will likely involve a partner.

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EVP Yann Mazabraud explained that while pediatric use in Europe has a significant clinical impact, its revenue impact is not major. He and CEO David Meeker clarified that the partnership strategy is evaluated country-by-country, using partners like Trispera where deep local expertise is advantageous over a direct model.

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Chairman, CEO and President David Meeker committed to providing an update on the CHI program in 2025, stating that good progress has been made in identifying a lead molecule. EVP, Head of International Yann Mazabraud noted that the company is selective and plans to launch in only 2 or 3 additional countries in the next 12 months by design, to ensure focus and sustainability.

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Chief Financial Officer Nick Pizzie projected that Cimbravo's gross-to-net will remain high, in the low 80% range, for the rest of the year. Chief Commercial Officer Ari Maizel identified the multi-mechanistic approach as a key differentiator, with early feedback highlighting its rapid onset and durability of response.

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Ari Maizel, Chief Commercial Officer, stated it was premature to provide a specific coverage cadence for SYMBRAVO but affirmed the team is focused on securing access quickly. Herriot Tabuteau, CEO, addressed solriamfetol, noting the encouraging ADHD data and highlighting that for binge-eating disorder, being potentially the second product approved would create a very favorable competitive dynamic, pending Phase III results.

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Chief Commercial Officer Ari Maizel confirmed that a broad-based media outreach for Auvelity is planned for the coming months, with spending timed to align with periods of high patient flow to HCP offices. He noted that specific plans for Symbravo's go-to-market strategy, including any DTC components, would be shared in the future.

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Chairman, President & CEO Ted Harris stated the new facility will be funded within the existing CapEx budget over three years and come online in late 2027/early 2028. He noted that while VitaCholine ProFlo is being introduced, a more significant opportunity is the inclusion of choline in nutritional beverages. He clarified that the focus on clinical studies is a continuation of their science-first strategy, not a pivot towards pharmaceuticals. EVP & CFO Martin Bengtsson confirmed the capital allocation strategy is unchanged, with a focus on paying down debt, and projected the full-year effective tax rate would be near the low end of the 22-23% range.

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Chairman, President and CEO Ted Harris confirmed that choline and vitamin K2 are significant tailwinds, with both categories showing strong double-digit growth, and highlighted strength in the food business. CFO Martin Bengtsson addressed the financial questions, stating that a weaker dollar could provide a $10-15 million annualized revenue tailwind, while transactional FX impact is immaterial. He noted that with leverage low, the company is evaluating M&A and may consider share buybacks. Bengtsson projected a full-year effective tax rate between 22% and 22.5%.

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Theodore Harris, Chairman, President & CEO, stated that marketing for VitaCholine Pro-Flo will leverage existing partnerships and social media to target the adult multivitamin market. He noted Balchem is well-positioned regarding tariffs, with minimal sourcing from China and Mexico. Carl Bengtsson, CFO, clarified the Q4 foreign tax impact was a one-off event and explained that the impact of the bird flu on demand is currently not significant as it is offset by other market dynamics.

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Chairman, President and CEO Ted Harris reported that Optifolin+ is performing ahead of expectations with an annualized sales rate of about $2 million. He explained that new products like VitaCholine Pro-Flo are accretive to gross margin and that Pro-Flo specifically opens up the significant multivitamin market. Harris confirmed plans to increase capital allocation to HNH marketing and R&D, focusing on social media. He noted anti-aging is a core focus, while Balchem's role in weight loss is more ancillary. CFO Carl Bengtsson added that the long-term tax rate is expected to remain in the 22-23% range and that the company's debt strategy remains flexible.

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President, CEO & Chairman Mihael Polymeropoulos explained that the Bisanti launch timing is a strategic decision and that current investments in the Fanapt sales force are directly transferable. CFO Kevin Moran clarified the Ponvory issue involves a disputed $3 million gross-to-net item from Q4 2024. Moran anticipates steady, not rapid, growth for Ponvory, while Polymeropoulos added that the sales force is being reset to increase prescriber frequency. Regarding Tradipitant, Polymeropoulos detailed the ongoing review for motion sickness and the pending hearing request for gastroparesis, noting the FDA has granted expanded access to over 100 patients.

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President and CEO Dr. Mihael Polymeropoulos stated that Bysanti will compete directly with CAPLYTA in treatment-resistant depression, highlighting a similar study design and a convenient once-daily dosing. He suggested Bysanti may offer tolerability advantages regarding akathisia and peripheral neuropathy. He clarified that the Fanapt LAI is entering Phase III first, while the Bysanti LAI remains in the formulation phase, though its chemical structure is amenable to creating long-duration lipid esters.

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CEO Mihael Polymeropoulos stated the Fanapt LAI program is ready to start but is pending FDA policy guidance after an IRB objection to a placebo-controlled design, with results not expected until 2027. He confirmed the 2025 revenue guidance only includes currently marketed products and that no new HETLIOZ generic competitors are expected. Executive Kevin Moran added that the primary reimbursement change, the Medicare benefit redesign, has already been factored into the 2025 financial projections.

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Executive Kevin Moran explained that PONVORY's payer mix leans heavily commercial, while Fanapt and HETLIOZ have a significant portion, likely over half, from governmental payers. CEO Mihael Polymeropoulos stated the Fanapt LAI pivotal study will begin in Q4 2024 and could take over two years. He noted they are initiating a study for milsaperidone in major depression. For PONVORY, an IND for ulcerative colitis was recently submitted, with work potentially starting next year, and an IND for psoriasis, backed by strong existing data, will be submitted shortly.

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CEO Daniel Barber and executive Sherry Korczynski described a phased launch strategy, prioritizing HCP awareness first, then layering in DTC (social media, digital) as payer access grows. For distribution, Korczynski stated it will be predominantly retail (CVS, Walgreens) but they are exploring alternate channels. Barber identified Canada, the U.K., and Germany as key ex-U.S. markets and confirmed engagement with their respective regulatory bodies is planned to support partnerships.

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CEO Daniel Barber commented that competitor awareness spending is a 'rising tide' that benefits the entire space. Regarding Libervant, he explained that court outcomes are uncertain but they are committed to fighting for patient access until VALTOCO's exclusivity expires in early 2027. CFO Ernie Toth attributed the wide revenue guidance to uncertainties surrounding Libervant revenue due to the court case and potential Suboxone erosion.

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CEO Daniel Barber confirmed that the AQST-108 program is on schedule, with the briefing book submitted to the FDA. Regarding Libervant, he stated that price has not been an obstacle and the filing will be timed to launch immediately upon ODE expiration. SVP, Chief Commercial Officer Sherry Korczynski noted that market research indicates Anaphylm's ease of use and carrying will appeal to new patients, those with existing prescriptions, and those who currently avoid treatment.

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CEO David Zaccardelli reiterated that biologics are seen as complementary, not competitive, due to different mechanisms and use cases, with Ohtuvayre's bronchodilation being a key differentiator. Chief Commercial Officer Christopher Martin added that physicians view Ohtuvayre as a broad-use foundational therapy. Regarding M&A, Zaccardelli confirmed the company aims to leverage its capabilities by acquiring mid- to late-stage assets, primarily in the respiratory space, to continue its growth.

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CEO David Zaccardelli and CCO Christopher Martin asserted that physicians view Ohtuvayre as a broad, foundational COPD therapy due to its unique bronchodilator and anti-inflammatory profile, making biologics complementary rather than competitive. On strategy, Zaccardelli stated that the company will actively look for mid-to-late-stage respiratory assets to leverage its commercial and development capabilities as the Ohtuvayre launch matures.

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Executive David Zaccardelli stated that while regions like Japan and South America are important incremental opportunities, the primary focus remains the U.S. launch and securing partners for ex-U.S. territories. Chief Commercial Officer Chris Martin addressed prescribing trends, noting the key driver is persistent symptoms. He believes that over time, Ohtuvayre's use will grow in patients on therapies other than triple therapy, as physicians seek effective non-steroidal options, which could reduce reliance on ICS.

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Executive David Zaccardelli stated that prescribing is broad across all patient types with no specific combination preference, though use on top of triple therapy is high due to unmet need. Chief Financial Officer Mark Hahn clarified that pre-approval manufacturing costs were expensed as R&D, while all ongoing commercial activities, like speaker programs, are booked as SG&A.

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Chief Commercial Officer Chris Martin detailed a multi-faceted marketing plan, highlighting digital outreach to over 50,000 physicians, leading to high engagement from nearly 7,000. He confirmed that speaker programs are being scheduled and that patient-focused marketing is active through a dedicated website and future point-of-care initiatives. An unnamed executive projected the non-CF bronchiectasis trial could take around two years to fully enroll.

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Executive Dror Bashan positioned Elfabrio as a strong alternative for adult Fabry patients, highlighting its safety profile and Chiesi's ongoing investment. For PRX-115, he noted active discussions with U.S. and European regulators about the Phase II plan. Bashan firmly stated that Protalix will not pursue a contract manufacturing (CMO) business model, instead focusing on its core strategy as a boutique development company for rare diseases to maximize shareholder value.

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Executive Dror Bashan stated that PRX-115 could be a very interesting alternative to existing gout enzymes, noting the company is aiming for a superior dosing profile. He confirmed the oral anti-TNF program has been discontinued and that Protalix is evaluating over half a dozen new early-stage programs, with updates expected in the next one to two quarters. Regarding capital structure, Mr. Bashan affirmed the plan to repay the convertible notes in September with cash on hand, without refinancing, citing sufficient resources and growing revenues that have moved the company to a more stable financial position.

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Dror Bashan, an executive, explained that PRX-115 is being developed for uncontrolled gout patients and that the company is optimistic following initial results, leading to preparations for a Phase II study. He stated the goal is to offer improved safety and better dosing frequency compared to existing treatments like KRYSTEXXA. Bashan confirmed the intention is for PRX-115 to compete directly in the uncontrolled gout market, and that the specific design of the Phase II trial and its endpoints would be finalized after discussions with regulators.

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