Anthea Li

Anthea Li asked about expectations for Q1 sequential quarterly growth, considering the expanded sales force versus seasonality and winter storms, and whether broader Medicare coverage for Voquezna is planned for the year and included in guidance.

Answer

Steven Basta, President and CEO, acknowledged typical seasonality and winter storms as headwinds, noting Q1 is usually the weakest quarter. Sanjeev Narula, Chief Financial and Business Officer, added that 40% of full-year revenue is expected in the first half, with Q1 being the slowest. Steven Basta also clarified that no broad Medicare coverage change is anticipated, but incremental Medicare prescriptions are being covered through appeals or specific Part D plans.

Anthea Li from Jefferies asked about the expectation for Q1 sequential quarterly growth given the expanded sales force, considering seasonality and winter storms, and any plans for broader Medicare coverage for VOQUEZNA this year.

Answer

Steven Basta, President and CEO, and Sanjeev Narula, Chief Financial and Business Officer, discussed typical seasonality, with Q1 expected to be the slowest quarter, similar to 2025 patterns. They clarified that no broad Medicare coverage change is anticipated, but incremental Medicare prescriptions are being covered through medical appeals or specific Part D plans.

Anthea Li asked about the expected timeline to achieve the $2 billion peak sales target, specifically if it would be before the 2032 composition of matter patent expiry and if secondary patents extend beyond that. She also sought details on what constitutes a meaningful trend for erythema in ocular rosacea and the scenario for achieving statistical significance on that endpoint.

Answer

Bobak Azamían, CEO and Chairman, stated it's too early to pinpoint the exact peak sales timeline but noted continued strong growth, expecting to reach $1 billion+ in a couple of years with no signs of slowing. Seshadri Neervannan, Chief Operating Officer, explained that for ocular rosacea, as a first-ever trial, they are focused on objective improvements in hallmark signs like erythema and telangiectasia, which ECPs consider meaningful given the lack of approved treatments, and they have FDA alignment on these measures.

Anthea Li inquired about the expected timeline for XDEMVY to achieve its $2 billion peak sales target, specifically asking if it would be before the 2032 composition of matter patent expiry, and sought clarification on what constitutes a meaningful trend on erythema in the ocular rosacea trial and the potential for statistical significance.

Answer

Bobak Azamian, Chief Executive Officer and Chairman, stated it's too early to provide an exact timeline for the $2 billion peak, but noted continued incredible growth, with the company a couple of years away from $1 billion. Seshadri Neervannan, Chief Operating Officer, explained that for the first-ever ocular rosacea trial, Tarsus is focused on objective improvements in hallmark signs like erythema and telangiectasia, with FDA alignment, and will evaluate data for meaningfulness given the lack of approved treatments.

Anthea asked about Ardelyx's confidence in IBSRELA's underlying volume growth to reach $430 million guidance, identifying key drivers beyond the total addressable market (TAM) and the assumed impact of pull-through improvements and the shift to specialty pharmacies.

Answer

CEO Mike Raab expressed significant confidence, citing the vast patient population needing new alternatives. Chief Commercial Officer Eric Foster detailed strategies including sales force optimization, doubling the field reimbursement manager team, and the high-touch IBSRELA Pharmacy Network to improve fulfillment rates and drive demand.

Anthea asked about the importance of Dr. Mitchell's testimony in the Daubert case for proving direct infringement and any associated risks, as well as Roivant's perspective on the competitive landscape for PH-ILD, specifically if sotatercept could be effective in the disease.

Answer

Matt Gline, CEO of Roivant, stated that he could not comment on ongoing litigation or specific Daubert motions. For PH-ILD, he acknowledged that any drug improving PVR could work, including sotatercept, but noted that systemic vasodilation has not been a highly effective approach. He believes Roivant will be the first non-prostacyclin/prostanoid in PH-ILD with a favorable profile.

Anthea, on behalf of Dennis Ding, asked about the importance of Dr. Mitchell's testimony to the Moderna case and any risk of it being excluded, and also questioned the competitive landscape for PH-ILD, specifically if sotatercept could be effective in the disease.

Answer

Matt Gline, CEO of Roivant, stated that Daubert motions are ongoing in the Moderna litigation, and the judge will make decisions, with anything being possible. Regarding PH-ILD, he acknowledged that sotatercept could theoretically work, but noted that systemic vasodilation has not been a highly successful approach in PH-ILD, and Roivant expects to be the first non-prostacyclin/prostanoid in the space with a favorable profile.

Anthea, on for Dennis Ding at Jefferies, asked about plans to share full data from the lupus study and its potential read-through to dermatomyositis (DM). She also inquired about physician willingness to prescribe JAK inhibitors in DM and the extent of current off-label use.

Answer

CEO Matt Gline noted the lupus study was run by Pfizer and that the total brepocitinib dataset is more informative than any single trial. Priovant CEO Ben Zimmer added that a key lesson from lupus was the importance of managing placebo response. He confirmed that JAKs are used 'pretty extensively' off-label in DM, citing published case reports, and that rheumatologists and dermatologists are very comfortable with the drug class.

Anthea, on behalf of Dennis Ding from Jefferies, inquired about the importance of Dr. Mitchell's testimony in the Daubert motion related to the Moderna litigation and the potential risk of it being excluded. She also asked about the competitive landscape for PH-ILD and whether sotatercept could be effective in this disease.

Answer

Matt Gline, CEO of Roivant Sciences, stated that he could not comment extensively on ongoing litigation but acknowledged the presence of various Daubert motions and expressed hope for favorable outcomes. Regarding PH-ILD, he noted that while systemic vasodilation hasn't been ideal, sotatercept theoretically could work, and Roivant's mosliciguat is expected to be the first non-prostacyclin/prostanoid in the space.

Anthea asked about the importance of Dr. Mitchell's testimony to the Daubert case for direct infringement and any risk of it being excluded, as well as thoughts on the PH-ILD competitive landscape and if sotatercept could work in the disease.

Answer

CEO Matt Gline stated that Roivant cannot comment on ongoing litigation or specific Daubert motions, as decisions are pending from the court. Regarding PH-ILD, he noted that while any drug improving PVR could theoretically work, systemic vasodilation hasn't been a great approach, and Roivant expects to be the first non-prostacyclin/prostanoid in the space.

Anthea Li of Jefferies inquired about Veru's new modified-release formulation of Inovasarm, asking about its potential for fixed-dose combinations with oral GLP-1s and any updates on ex-U.S. partnering discussions.

Answer

Chairman, President & CEO, Mitchell Steiner, confirmed that a fixed-dose combination with oral GLP-1s is feasible and could extend patent life. He stated that Veru is actively engaged in partnership discussions with three categories of companies: established GLP-1 market leaders, large pharmaceutical companies looking to enter the weight-loss space, and companies developing their own GLP-1s that need a differentiator. The primary goal of these discussions is to secure non-dilutive funding for future studies.

Anthea Li, on for Dennis Ding of Jefferies, questioned the potential for a fixed-dose combination of oral enobosarm with oral GLP-1s, the comparative hsCRP reduction of sabizabulin versus Colchicine, and the feasibility of a Phase II study given the company's cash position.

Answer

Chairman, CEO, and President Dr. Mitchell Steiner confirmed a fixed-dose oral combination is possible and attractive. Regarding sabizabulin, he stated that while its mechanism is similar to Colchicine, it has a superior safety profile without the drug-drug interactions with statins, making it a "safety play." He expects similar or better hsCRP reduction. Dr. Steiner also affirmed the company has sufficient cash to operate through the end of the calendar year, covering key data readouts.

Anthea Li, on for Dennis Ding, requested an update on enrollment and follow-up in the long-term extension study for CAH and asked what would constitute a critical mass of data for a public update.

Answer

Dr. R. Struthers, CEO, confirmed that enrollment in the open-label extension (OLE) is ongoing but declined to provide specific numbers or timing for a data release. He emphasized the OLE's value in gathering real-world evidence and stated that data would be presented at a scientific meeting once a sufficient dataset is available.