Anupam Rama • JPMorgan Chase & Co.

Answer

Josh Smiley, President & COO, confirmed that both ZAKDURO and ONCTYRO are expected to show good growth in the second half of the year. He noted that while ZAKDURO's near-term growth might be modestly limited by supply constraints, underlying demand is strong. He also stated that NUZYRA continues to be a strong and consistent driver of growth for the company.

Ask Fintool Equity Research AI

Answer

Dr. Rafael Amado, President and Head of Global R&D, stated the ASCO update will feature the complete dose escalation dataset and new data from the dose optimization cohort of about 50 patients. He advised focusing on which dose demonstrates the most promising therapeutic benefit to carry forward into the pivotal trial.

Ask Fintool Equity Research AI

Answer

Joshua Smiley, President and Chief Operating Officer, responded that while VYVGART is expected to grow faster than the overall rate, strong growth is also anticipated from the base business, particularly ZEJULA and NUZYRA. He also noted that newly launched products AUGTYRO and XACDURO will contribute to the overall strong performance across the portfolio.

Ask Fintool Equity Research AI

Answer

President and Chief Operating Officer Josh Smiley responded that Zai Lab is targeting 1,000 key hospitals for NRDL pull-through. He stated the goal is to have at least two-thirds of these hospitals complete the listing process by the end of the first half of 2024, confirming they are well on track to meet this objective.

Ask Fintool Equity Research AI

Answer

Dr. William Rote, Chief Research Officer, responded that interactions with the FDA, viewed through the lens of the two ongoing sNDAs (REMS modification and FSGS), have been progressing as expected. He noted the frequency and types of questions have been very similar to the process for the full IgA nephropathy approval, indicating an engaged and active review team.

Ask Fintool Equity Research AI

Answer

Chief Financial Officer Chris Cline explained that while Q1 typically has the highest discounts, the impact of the Part D redesign will make the GTN discount 'a bit stickier' and more even throughout 2025 compared to 2024. He reiterated guidance for GTN in the low 20s for the year, up from the mid-to-high teens last year.

Ask Fintool Equity Research AI

Answer

SVP of Research and Development Dr. Bill Rote confirmed that the submission included a substantial body of pooled data from ongoing clinical trials, open-label extensions (DUET, DUPLEX, PROTECT), and commercial real-world experience. He stressed that the safety profile, showing low levels of LFT elevation and no liver injury, remained consistent across this larger dataset.

Ask Fintool Equity Research AI

Answer

Emil Kakkis, Founder, President & CEO, clarified that the FDA requested a routine update of the ongoing clinical endpoint data (Bayley, Vineland) and biomarker data. He explained this was primarily because time has passed since the initial submission, and the agency wants to see the latest information from patients who have continued in the study.

Ask Fintool Equity Research AI

Answer

Chief Medical Officer Eric Crombez confirmed that the company is on track to achieve its goal of fully enrolling the 120-patient pivotal study within the year. He stated that global sites in the U.S., Europe, and Japan are active and currently screening patients for the trial.

Ask Fintool Equity Research AI

Answer

CEO Emil Kakkis confirmed that if the Orbit study hits its endpoint, the company would proceed to final analysis and file for approval quickly. He indicated this would likely only cause a one-quarter delay compared to a scenario where the interim analysis was the final one.

Ask Fintool Equity Research AI

Answer

Chief Commercial Officer Matthew Outten explained that physicians who prescribe Atruvy see its rapid efficacy, which reinforces their decision and leads to more prescriptions. He noted that positive experiences are shared within both physician and patient communities, driving growth in both academic (COE) and community settings, and he expects this trend to continue.

Ask Fintool Equity Research AI

Answer

CEO Neil Kumar highlighted the indication as a large extension population with a favorable pricing environment, making it an attractive opportunity. COO of BridgeBio Cardio Reno, Ananth Sridhar, added that recent proof-of-concept data was strong, with 78% of participants normalizing calcium levels, and noted the HP market is 7-8 times larger than the ADH1 market alone.

Ask Fintool Equity Research AI

Answer

CFO Keith Goldan confirmed that Syndax expects to reach profitability with its current funds, driven by outperforming launches. He stated that profitability is achievable based solely on the relapsed/refractory indications for Revuforge and Nyktymbo, without relying on future frontline approvals. He also noted that operating expenses are expected to remain stable for the next few years while fully funding strategic priorities.

Ask Fintool Equity Research AI

Answer

CFO Keith Goldan stated that inventory levels are expected to remain stable at 2-3 weeks in the channel, though the absolute dollar value will grow with revenue. CCO Steven Closter noted that while specific repeat prescriber numbers are not yet provided, the majority of ordering accounts have prescribed Revuforj more than once, indicating positive initial experiences and habit formation.

Ask Fintool Equity Research AI

Answer

EVP of Commercial, David Acheson, explained that as total injection volume grows, the use of free goods also increases, driven by the ongoing shortage in co-pay foundation funding. He stated that Apellis expects to see similar trends and impact from free goods usage throughout the remainder of 2025.

Ask Fintool Equity Research AI

Answer

Executive David Acheson confirmed that SYFOVRE maintains its preferred positioning on several large Medicare Advantage plans and has not seen significant changes. He emphasized that SYFOVRE's efficacy with every-other-month dosing remains a key differentiator for both physicians and payers, solidifying its competitive position.

Ask Fintool Equity Research AI

Answer

EVP of Commercial David Acheson responded that Apellis is fortunate to already have preferred positions with several sizable payers. He noted that conversations with payers focus on SYFOVRE's strong efficacy data with every-other-month dosing, which is in the label, but he refrained from predicting future payer decisions.

Ask Fintool Equity Research AI

Answer

COO Adam Townsend affirmed that the field force is believed to be rightsized. He detailed new initiatives to drive referrals, including a dedicated ophthalmology field team and a digital optometry team. He noted that while sampling plays a smaller role in a buy-and-bill model with established reimbursement, it is expected to constitute about 5% of vial demand, particularly for physicians new to prescribing SYFOVRE.

Ask Fintool Equity Research AI

Answer

CMO Sanjay Keswani and Strategic Advisor Eiry Roberts explained that the study was a valuable learning opportunity. While it missed the primary endpoint, it showed a positive efficacy signal in the PANSS positive symptom scale, which helps inform the target population for future programs. Roberts added that the study confirmed valbenazine's safety profile in this population and provided interesting signals across various sub-scores that will be published and used to guide the next-generation VMAT2 inhibitors.

Ask Fintool Equity Research AI

Answer

Chief Commercial Officer Eric Benevich attributed the record starts to two main factors: the tangible benefits from the recently expanded sales force, particularly in psychiatry and long-term care, and enhanced marketing initiatives focused on better differentiating INGREZZA from its competitors.

Ask Fintool Equity Research AI

Answer

CEO Kyle Gano responded that while growth is expected across psychiatry, long-term care (LTC), and neurology, the largest opportunity remains in the psychiatry segment. He mentioned that headwinds like provider turnover and telemedicine in psychiatry are being addressed by the recent sales force expansion, which aims to increase the frequency of interactions with healthcare providers.

Ask Fintool Equity Research AI

Answer

CFO Matt Abernethy confirmed that, consistent with the past two years, the company will not pre-announce revenue at the January conference. He stated that Q4 results and full-year 2025 sales guidance will be provided during the February earnings call.

Ask Fintool Equity Research AI

Answer

EVP & Chief Commercial Officer Ross Moat explained that while the core focus remains the 15% penetrated 'two-plus recurrence' population, the first recurrence setting represents a significant growth opportunity with 26,000 patients. He attributed the increasing use in this earlier stage to growing physician confidence, familiarity with Arcalis, and a better understanding of recurrent pericarditis as an IL-1 alpha and beta mediated disease.

Ask Fintool Equity Research AI

Answer

Chief Commercial Officer Ross Moat clarified that the company is agnostic to the practice setting (academic vs. office-based) and focuses its sales force on cardiologists with the highest throughput of recurrent pericarditis patients, identified through data analysis. He stated this targeted approach is driving the consistent quarterly growth in the prescriber base.

Ask Fintool Equity Research AI

Answer

Ross Moat, Chief Commercial Officer, stated that while ARCALYST acceptance is high, a monthly liquid formulation could be advantageous for patient preference. Dr. John Paolini, Chief Medical Officer, confirmed the data shown was for a subcutaneous dose, supporting a monthly dosing schedule.

Ask Fintool Equity Research AI

Answer

CEO Sanj K. Patel acknowledged the company's past cadence but stated that no final decision has been made regarding the timing of pre-announcements or guidance for the upcoming year. He indicated they are still evaluating their plans.

Ask Fintool Equity Research AI

Answer

CEO Sushil Patel explained that Replimune will present new data at ASCO building on the IGNYTE study. The presentations will detail response rates based on whether superficial, visceral, or a combination of lesions are injected, providing a rationale for injecting deeper lesions. Patel also highlighted a poster on safety, showing RP1 is easily neutralized by common disinfectants and does not cause infections in patients or their contacts.

Ask Fintool Equity Research AI

Answer

Head of R&D Dr. Louise Rodino-Klapac clarified that the update was focused on safety information, specifically to include the case of acute liver failure (ALF) and the patient death. She stated this was the breadth of the update and did not mention the inclusion of other data sets.

Ask Fintool Equity Research AI

Answer

President and CEO Doug Ingram stated that the company's primary focus is on the successful launch of ELEVIDYS, the performance of its PMO franchise, and advancing its internal pipeline, particularly the LGMD programs. Regarding the January conference, he noted that while no commitment was being made, Sarepta would likely be consistent with its history of pre-announcing results.

Ask Fintool Equity Research AI

Answer

CEO Douglas Ingram stated that while he would not provide more granular long-term guidance, peak year sales for ELEVIDYS are expected to occur significantly in the back half of the current decade. He reiterated that the company will be treating the prevalent patient population throughout the decade before shifting to the incident population in the 2030s.

Ask Fintool Equity Research AI

Answer

President and CEO Bradley Campbell explained that the U.K.'s industry association negotiated a 22% rebate rate, significantly above the 15% maximum the company had conservatively planned for. Campbell described it as a frustrating, onetime reset for the year's forecast, noting that strong patient growth for Galafold should offset the impact, while Pombiliti/Opfolda's guidance was revised to account for it.

Ask Fintool Equity Research AI

Answer

President and CEO Bradley Campbell stated that in established markets like the U.S., Europe, and Japan, growth is driven by penetrating the diagnosed-but-untreated population and new diagnoses from screening initiatives. In newer markets, such as Latin America and Southeast Asia, there remains a significant opportunity to switch patients from existing therapies in addition to finding new patients.

Ask Fintool Equity Research AI

Answer

President and CEO Bradley Campbell confirmed strong growth across all key markets. Chief Business Officer Sebastien Martel added detail, highlighting robust demand from naive patients in the U.S., with new patient starts near a five-year high. Martel also pointed to strong performance in Europe, particularly the U.K., and significant growth potential in Japan.

Ask Fintool Equity Research AI

Answer

Chief Operating and Financial Officer Charles York explained that while the company disclosed stocking inventory in Q2, going forward it will guide to a standard 2-4 weeks of channel stock and will not provide a specific dollar value unless it deviates materially from that range.

Ask Fintool Equity Research AI