Ryan Deschner • Raymond James

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Co-Founder, President & CEO Richard Lowenthal expressed confidence in continued quarter-over-quarter growth through Q4, expecting the DTC campaign to have a notable impact during the back-to-school season. Regarding market expansion, he stated that while current data is anecdotal, they are hearing about adoption from all segments, including patients new to epinephrine therapy. A formal market analysis to quantify these sources is planned for later in the year.

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President and CEO Richard Lowenthal stated that inventory had very little influence on Q1 sales. CFO Kathleen Scott explained that the gross-to-net discount was over 60% in Q1, down from Q4, and is expected to trend towards 50% as insurance coverage improves.

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Richard Lowenthal, Co-Founder, President and CEO, explained that the 1mg dose, representing 23% of the market, is additive and expected to significantly boost the sales ramp, as early adoption is heavily weighted toward children. He stated that ARS Pharma will achieve 51% unrestricted commercial access by April 1 and is on track to reach nearly 80% by July 1, following a key agreement with Zinc which covers CVS Caremark.

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Executive Eric Karas explained that cash payments are slightly higher than expected, driven by strong patient interest. He detailed that about a third of scripts are covered directly, with prior authorizations succeeding 50-55% of the time. Executives Richard Lowenthal and Eric Karas clarified that while data providers like IQVIA log each device as a unit, their co-pay program can consolidate charges for patients, and the number of units per prescription aligns with their expectations for patients needing multiple devices.

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CFO & COO Michael Kaseta reported that less than 50% of starts utilized the free 28-day voucher program, which is in line with launch expectations. CCO Scott Moomaw explained that while the focus is on new-to-prostacyclin patients, they have been surprised by the high volume of switches from Tyvaso DPI and other products. CEO Roger Jeffs added this switch volume from intolerant patients was a key driver of the launch's upside.

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Chief Commercial Officer Scott Moomaw provided the expected payer mix: approximately 50% Medicare, 35% commercial, 10% Medicaid, and 5% other. On the legal question, General Counsel Russell Schundler declined to comment on the specifics of the active '494 patent litigation, stating that the company's position is outlined in the public complaint.

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CEO Dr. Roger Jeffs explained that specific details about the nebulizer are being withheld at this time due to its proprietary nature and ongoing intellectual property efforts, with more information to be disclosed in coming quarters. He reiterated its key features as an iPhone-sized, portable, breath-actuated device that allows for precise drug delivery and dosing.

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Chief Development Officer James Cassella confirmed that deep-dive analyses reinforce that the 54mg dose is the key anchor dose. CEO Jennifer Good added that there were no surprises in the safety profile. She clarified that RCC data will be presented at ERS, while the more extensive IPF data from the CORAL trial is slated for presentation at the CHEST conference in October.

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Executive Jennifer Good responded that the top-line Q2 IPF data will include the primary endpoint and key secondary endpoints like EXACT2 and CSS, but she was uncertain about other exploratory metrics. For future RCC studies, she stated there are no plans to stratify by cough frequency (e.g., moderate vs. severe), as the drug showed a strong effect across the entire range of patients.

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CEO Jennifer Good explained that the DEA review process occurs late in the drug approval cycle, as part of the NDA review, and sometimes a referral to the DEA is not even made by the FDA. She stated the butorphanol dose is a 6-milligram infusion over one hour, a dosage level that was agreed upon with the FDA to mimic the pharmacokinetics of an existing inhaled version while allowing for proper study blinding.

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Co-Founder & CEO Chris Peetz and COO & President Peter Radovich attributed the growth to increased awareness and diagnosis of later-onset PFIC, which expanded the market beyond initial expectations. Radovich noted the tablet was launched in June, so its impact was not reflected in Q2 results, but early feedback is positive.

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CEO Christopher Peetz described the tablet as a highly attractive option for patients over 25 kilos due to reduced pill burden. He anticipates a substantial minority of patients will find it appealing and believes it could drive both switches from the liquid solution and new patient starts, especially among teenagers and young adults seeking convenience.

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CEO Chris Peetz stated that no field team expansion is expected for the potential new indication, as it leverages the existing prescriber base. Regarding patient weight, he described the impact as a modest and gradual increase in the average dispense value, which is tempered by new infant patient starts.

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CCO Eric Foster confirmed the expanded sales team's increased activity was a significant driver of growth in prescribers and prescriptions, and he expects this to continue. Regarding seasonality, he acknowledged that Q1 is typically the most impacted quarter and that the company remains mindful of potential summer vacation impacts in Q3.

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CEO Michael Raab and CCO Eric Foster attributed the market contraction to a consistent seasonal trend that is more apparent as IBSRELA's volume grows. Regarding gross-to-net for XPHOZAH, CFO Justin Renz stated it was 32% in Q1 (excluding the reserve release), and Raab advised modeling 30% +/- 5% going forward. Raab noted there were no new updates to share on the China launch.

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CCO Eric Foster indicated that XPHOZAH's promotional sensitivity remains strong and consistent with 2024 levels. CFO Justin Renz stated it is too early to provide long-term gross-to-net guidance but expects it to be less favorable in 2025 than in 2024 due to the changing payer mix.

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President and CEO, Mike Raab, and Chief Commercial Officer, Eric Foster, confirmed the sales team is fully trained and deployed. They noted that early positive impacts are visible from the first hires, which gives them confidence for future growth. Raab also stated that Chinese approval for XPHOZAH is still anticipated by year-end, with no new updates on other partnerships.

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EVP David Acheson said that initially, total start forms will be reported, with breakdowns by indication to follow over time. CMO Dr. Caroline Baumal noted that the one-time REMS certification is standard for complement inhibitors and is not expected to be a significant burden for physicians.

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Executive Timothy Sullivan stated that the Q4 inventory build was a specific event tied to the competitor's CRL and is now settled. He views the co-pay issue as a one-time event with a continuing effect, not something that would cause a similar inventory dynamic in the future. An unnamed executive added that the DTC campaign has been very positive, driving a 30% higher average quarterly traffic to the website in Q1 2025 compared to the 2024 average.

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CFO Tim Sullivan confirmed that the gross-to-net guidance for 2025 remains unchanged in the low-to-mid 20% range. EVP of Commercial David Acheson noted it was early to measure the full DTC impact but shared a positive early indicator: a single TV spot during a high-profile event drove approximately 3,000 visits to the company's website.

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President & CEO Brian Lian responded that while satiety signals can be inconsistent across studies, they were observed in the Phase I trial. He confirmed that the Phase II data release will include all parallel cohorts simultaneously, noting the maintenance arm that steps down in dosage will be particularly interesting.

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Brian Lian, President and CEO, explained that the initial clinical study for the amylin candidate will be a standard single-ascending and multiple-ascending dose (SAD/MAD) trial. While the company is interested in evaluating a combination regimen with VK2735, this would likely occur next year, after establishing the single-agent profile.

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CEO Brian Lian explained that full study design details will be provided upon trial initiation. He confirmed the program will adhere to regulatory guidance, requiring at least 4,500 participants across two studies: one for obesity and another for obesity with type 2 diabetes. These trials will utilize multiple doses and have a 52-week treatment duration.

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President and CEO Paul Bolno stated that the company is actively planning for late-stage studies, including an 'off-ramp' trial design where patients stable on a GLP-1 would be switched to WVE-007. He noted these studies are being designed to generate meaningful data for clinical use and to support a broad label covering monotherapy and maintenance use cases for reimbursement.

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