Dennis Ding

Dennis Ding inquired about the expected ramp-up and full productivity timeline for the recently expanded sales force, and the reasons behind the 12-month EU filing timeline for YCANTH despite no additional clinical trials, including potential for a partnership before filing.

Answer

Jayson Rieger, President and CEO, stated that new sales reps typically take a few months to become productive, expecting them to be effective early next year. He explained the EU filing timeline is due to mechanical steps, such as securing a pediatric waiver, and that the timeline allows for preparing a commercial plan or finding a partner without adversely impacting the commercial launch.

Dennis Ding inquired about the expected ramp-up period for sales force productivity, particularly for 2026, and the reasons behind the 12-month timeline for EU filing despite no additional clinical trials, including potential partnership considerations before filing.

Answer

Jayson Rieger, President and Chief Executive Officer, explained that new sales representatives typically achieve full productivity within a few months, with significant impact expected early next year. For the EU filing, he cited mechanical steps, such as securing a pediatric waiver, as contributing to the timeline, which also provides a runway for commercial planning or partnership.

Dennis Ding inquired about Pulmovant's phase II PHILD data, the translatability from PAH, expectations for PVR delta, and also asked for an update on the LNP litigation regarding OUS trials and the percentage of U.S. doses given to federal employees.

Answer

CEO Matt Gline expressed cautious optimism for mosliciguat's translatability from PAH to PHILD, noting PVRs generally translate well and highlighting the 38% PVR reduction in PAH. For LNP litigation, he stated the percentage of doses to federal employees is relatively small. Regarding OUS trials, he mentioned filings in Europe (UPC), Canada, and Japan, with important hearings in 2026 and potential outcomes in some European jurisdictions within that year.

Dennis Ding inquired about the confidence in mosliciguat's translatability from PAH to PHILD for the upcoming Phase 2 data and the status of LNP litigation in OUS trials.

Answer

CEO Matthew Gline expressed cautious optimism for mosliciguat's translatability, noting PVRs generally translate well and the drug's format addresses VQ mismatch. He expects significant PVR reductions. For OUS LNP trials, he mentioned filings in Europe (UPC), Canada, and Japan, with important hearings and potential outcomes in some jurisdictions in 2026.

Dennis Ding asked for clarification on the VALOR trial design, specifically how a disease 'flare' is defined and treated, and how steroid rescue is managed. He also questioned if the reported 40% steroid elimination was a blinded figure and the potential impact of a treatment-placebo imbalance on the primary endpoint.

Answer

CEO Matt Gline clarified that the trial protocol focuses on a consistent definition of 'rescue therapy' rather than 'flare' to capture worsening patients accurately. He confirmed the 40% steroid elimination is a blinded, pooled number and acknowledged the theoretical risk of an imbalance. However, he described the mandatory steroid taper as a 'belt and suspenders' approach to maximize the trial's chance of success, noting that previous DM trials have succeeded without one.

Dennis Ding from Jefferies Financial Group questioned how Roivant plans to position brepocitinib in the dermatomyositis (DM) market relative to IVIG and which patient segments are considered low-hanging fruit. He also asked about the extent of off-label JAK inhibitor use in DM and the potential for pent-up demand.

Answer

CEO & Director Matt Gline indicated that Roivant views the entire DM market as addressable, considering many patients as "low-hanging fruit" due to the lack of options. He noted extensive physician familiarity with JAKs in DM, evidenced by hundreds of case reports and investigator-initiated trials, suggesting strong potential uptake. He deferred more detailed answers to the upcoming June 17 investor event.

Dennis Ding asked for clarification on the potential outcomes of the LNP litigation summary judgment, particularly whether Moderna could be held partially liable for damages.

Answer

CEO Matthew Gline explained that while he couldn't comment extensively on ongoing litigation, there could be a range of outcomes. He noted that the court has twice declined Moderna's requests to dismiss claims based on the 1498 defense. Gline also highlighted that the government's own statement of interest suggested one of its two contracts with Moderna may not have been made with the required 'authorization and consent,' implying liability might not be fully transferred to the government.

Georgia Banks, on behalf of Dennis Ding, asked whether the initial PWS data disclosure in December would include a go/no-go decision for phase three, or if there's a scenario where Rhythm Pharmaceuticals would wait for longer follow-up.

Answer

David Meeker, Chairman, CEO and President, confirmed that waiting for a longer follow-up before making a final go/no-go decision for phase three is a definite scenario, as the initial December data will be incomplete.

Georgia Banks, on behalf of Dennis Ding, asked whether the initial Prader-Willi Syndrome (PWS) data disclosure in December would include a go/no-go decision for moving into Phase III, or if Rhythm Pharmaceuticals might wait for longer follow-up.

Answer

David Meeker, Chairman, CEO and President, Rhythm Pharmaceuticals, confirmed that a scenario exists where Rhythm Pharmaceuticals might wait for a longer follow-up before making a definitive go/no-go decision for Phase III, especially given the incomplete nature of the initial data. He stated that all options are on the table, depending on the strength of the data signaling.

Dennis Ding of Jefferies Financial Group inquired about the Prader-Willi trial, asking what guidance is given to the investigator regarding patient enrollment, especially given the availability of another therapy (Vicart), and if this could enroll more challenging patients.

Answer

David Meeker, Chairman, President & CEO, explained that the trial's inclusion criteria allow for patients who are stable on Vicart, as studying the combination is of interest. He acknowledged that the trial is enrolling a mix of patients, including some with diabetes, who can be more challenging to treat and manage in a weight loss study, which will be considered in the final analysis.

Dennis Ding from Jefferies asked about critical commercialization factors to compete with a larger player, other potential indications for an ASI, and whether the company is considering a trial in primary aldosteronism.

Answer

CEO Jon Congleton stated that a key commercial factor is maximizing reach to the ~50,000 key prescribers, and partnership considerations include existing coverage and relationships. He highlighted OSA as another promising indication due to its overlap with hypertension. Regarding primary aldosteronism, he confirmed it is an area of consideration as the company evaluates future development options.

Dennis Ding from Jefferies Financial Group questioned if the new Ibsrela revenue guidance was conservative given strong script trends and asked for clarification on Xphozah's Q2 gross-to-net (GTN) of 29%, which seemed favorable despite the payer mix shift.

Answer

President and CEO Mike Raab described the Ibsrela guidance increase as a "meaningful step" that reinforces long-term projections. CFO Justin Renz explained that Xphozah's 29% GTN was driven by improvements in commercial co-pay assistance, which is typical as the year progresses. He expects the GTN to remain in the 29% to 31% range for the rest of the year.

Dennis Ding of Jefferies questioned the discrepancy between third-party script data and reported IBSRELA revenue of $44 million, and also asked for an update on the CMS litigation appeal for XPHOZAH.

Answer

CEO Michael Raab stated that all briefs for the CMS litigation have been filed and they are awaiting a court date. Raab and CCO Eric Foster addressed the revenue question by highlighting typical Q1 dynamics like insurance resets, wholesaler buying patterns, and higher co-pays that impact net sales, while stressing that underlying prescription demand was the second-highest on record and they remain confident in their full-year guidance.

Dennis Ding of Jefferies Financial Group asked a two-part question regarding the DMX200 program for FSGS and the Pombility/OpFolda launch. He sought more detail on the FDA's alignment on proteinuria as an endpoint and the potential impact from Travere's AdCom. He also asked about the expected revenue exit rate for Pombility/OpFolda in 2025 and new country launches planned for 2026.

Answer

Chief Development Officer Dr. Jeff Castelli confirmed clear FDA feedback on the suitability of proteinuria as a primary endpoint for DMX200 and viewed the upcoming Travere AdCom as a net positive for the field. President and CEO Bradley Campbell stated that while a specific 2026 run-rate is TBD, they expect higher absolute revenue growth for Pombility/OpFolda next year and named Australia and Canada as key markets for 2026 expansion.

Dennis Ding of Jefferies questioned the differentiation of DMX-200's CCR2 mechanism, given a prior Phase II failure in FSGS by ChemoCentryx with a drug targeting the same mechanism.

Answer

Chief Development Officer Dr. Jeff Castelli explained that DMX-200 is highly differentiated. Unlike traditional CCR2 binding inhibitors that can cause a rebound effect, DMX-200 acts downstream to block signaling from a specific heteromer on damaged kidney tissue. This approach stops the inflammatory signal without causing a surge in MCP-1 levels and preserves normal monocyte function elsewhere in the body.

Dennis Ding asked about the new 2024 Pombiliti guidance, which implies a relatively flat Q4, and questioned the level of conservatism. He also asked if the launch trajectory is expected to be steady or if an acceleration point is anticipated.

Answer

President and CEO Bradley Campbell responded that the guidance includes some incremental growth for Q4, but the final result depends on the rate of new patient additions in existing markets. He suggested that future acceleration could be driven by new country launches in the latter half of next year and as more U.S. patients on competing therapies become candidates for a switch.

Dennis Ding of Jefferies Financial Group asked if Indivior's cost-cutting initiatives aim to align SG&A spending as a percentage of revenue with industry peers, which he suggested is around 30%, implying a potential $200 million reduction in operating expenses.

Answer

CFO Ryan Preblick responded that while the company's cost structure is too high, the primary focus is resourcing SUBLOCADE for growth while eliminating non-essential spending. He declined to commit to a specific SG&A target percentage but affirmed that the organization is being assessed from top to bottom and that the benefits of this work will be seen in 2026.

Anthea on behalf of Dennis Ding of Jefferies Financial Group Inc. asked about the minimally clinically important difference (MCID) for the stair climb power measure, what would constitute a successful outcome in Phase II, and the rationale for pursuing a broad obesity population versus only elderly patients in Phase III.

Answer

Dr. Mitchell Steiner, Chairman, CEO, and President, explained that the FDA is open to an 'all-comers' obesity indication, with a Phase III primary endpoint likely focused on incremental weight loss alongside functional benefits. Dr. K. Barnette, Chief Scientific Officer, added that success for the stair climb in Phase II would be any observable separation from placebo to inform the Phase III design. He outlined a potential Phase III powered for weight loss in the overall population and for the stair climb functional endpoint in the elderly subgroup.

Asked for clarification on why a higher placebo effect is expected and questioned the drug's previously observed lack of impact on quality of life metrics, asking if that will be measured again.

Answer

The expectation of a higher placebo effect stems from factors like the randomization ratio and increased trial awareness, not changes in study design. The company is still working to identify the most relevant quality of life endpoints for NP, as standard tools may not be appropriate, and this is an ongoing effort for the pivotal program.