Corinne Johnson

Corinne Johnson asked about Roivant's strategy for further development expansion opportunities for brepocitinib, how the recent data informs this direction, and the potential market size for cutaneous sarcoidosis relative to NIU and dermatomyositis.

Answer

Matt Gline, CEO of Roivant, expressed enthusiasm for brepocitinib's further development, noting its strong agent profile in high-unmet-need patient populations and the large orphan market opportunity. Benjamin Zimmer, CEO of Priovant Therapeutics, added that the data reinforces the alignment of TYK2 JAK1 inhibition with T-cell polarization, supporting its distinctive benefits.

Corinne Johnson asked about Roivant's strategy for further development expansion opportunities for brepocitinib, how the recent data informs this direction, and the potential market size for cutaneous sarcoidosis relative to NIU and dermatomyositis.

Answer

Matt Gline, CEO of Roivant, expressed enthusiasm for brepocitinib's continued development in high unmet need, large orphan markets. Benjamin Zimmer, CEO of Priovant Therapeutics, added that the data reinforces the mechanistic alignment of TYK2 JAK1 inhibition to TH1/TH17-driven T-cell polarization and type 1 interferon suppression.

Corinne Johnson asked about the evolving competitive clinical landscape in Graves' disease and its impact on sequencing decisions, and also requested an update on business development.

Answer

CEO Matt Gline highlighted FcRn as a well-understood, safe, and effective mechanism exquisitely suited for Graves' disease biology, positioning it as an important early-line therapy. He noted that increased activity in the space benefits all. For business development, he mentioned strong capitalization, excitement for pipeline expansion, and a focus on programs that can significantly impact the existing pipeline.

Corinne Johnson asked about the evolving competitive clinical landscape in Graves' disease and what factors will inform sequencing decisions, as well as an update on business development.

Answer

CEO Matthew Gline highlighted FcRn's strong position in myositis and its suitability for Graves' biology, emphasizing its safety profile. He believes increased market activity will benefit all. On business development, he noted Roivant is well-capitalized and actively seeking pipeline expansion opportunities of significant scale.

Corinne Johnson requested context on the upcoming Graves' disease remission data for batoclimab, asking what would constitute a clinically meaningful outcome. She also inquired about Roivant's business development outlook, including the types and sizes of deals being considered given its significant cash balance.

Answer

CEO Matt Gline explained that physicians consider any level of remission in this refractory Graves' patient population to be practice-changing, suggesting even a 10% rate would be an 'extraordinary outcome.' On business development, Gline stated that the current market is attractive for an 'asset hunter' and that Roivant will remain opportunistic, looking at potentially transformational late-stage assets.

Eric, on behalf of Corinne Johnson, asked for more detail on the HO launch, specifically the process and cadence of reimbursement and the anticipated gross-to-net ratio compared to BBS.

Answer

David Meeker, Chairman, CEO and President, explained that the gross-to-net ratio is primarily driven by the Medicare/commercial mix (around 50/50 for BBS) and Medicaid share, with potential for a favorable shift if Medicare access is gained. Jennifer Lee, EVP, Head of North America, reiterated ongoing payer engagement and the ability to secure reimbursement even before formal policies are in place, leveraging the experience gained with BBS.

Eric, on behalf of Corinne Johnson, requested more color on the process and cadence of reimbursement for the HO launch and the anticipated gross-to-net, specifically in comparison to BBS.

Answer

David Meeker, Chairman, CEO and President, Rhythm Pharmaceuticals, stated that the gross-to-net for HO is difficult to predict but will primarily depend on the Medicare/commercial mix, as rebates are not a significant factor. Jennifer Lee, EVP, Head of North America, Rhythm Pharmaceuticals, explained that Rhythm is already engaging with payers for pre-approval information exchange. She anticipates a similar reimbursement process to BBS, where access was secured even before formal payer policies were in place, leveraging the existing knowledge of the drug.

Corinne Johnson of Goldman Sachs asked for clarity on the nature of the clinical data that might be shared for the RM-718 weekly formulation later this year. She also inquired about any visibility into off-label use of setmelanotide for younger patients in the U.S.

Answer

David Meeker, Chairman, President & CEO, clarified that due to enrollment timelines for the RM-718 study now extending into Q1 2026, it is 'extremely unlikely' any data will be shared by the end of this year. Jennifer Lee, EVP & Head of North America, responded that off-label use for HO in the U.S. is currently minimal, with only a handful of prescriptions received to date.

Corinne Johnson asked about INGREZZA's share of new-to-category or new-to-class patients versus Osado, where it could go, and how it compares to a year ago, especially with the expanded sales force.

Answer

Eric Benevich, Chief Commercial Officer, explained that new patient starts are a single-digit percentage of total prescriptions but are critically important due to high persistency. He stated that INGREZZA is currently gaining the majority of new patient starts, driving increased total market share, a trend they intend to continue with the sales force expansion.

Corinne Johnson asked about INGREZZA's share of new-to-category or new-to-class patients versus Osado, and where that share could go with the expanded sales force over the next year, contextualizing it against a year ago.

Answer

Eric Benevich, Chief Commercial Officer, explained that new patient starts (NRX) are a single-digit percentage of total TRX but are critically important due to high persistency. He stated that since the beginning of the year, with prior sales force expansion and increased formulary coverage, INGREZZA is capturing the majority of new patient starts, driving increased total market share. He intends to continue this momentum into 2026 and the critical 2027 period.

Corinne Johnson of Goldman Sachs inquired about the reimbursement process for Crinesity, asking when it might become more formulary-driven and how that could affect net pricing.

Answer

CCO Eric Benevich explained that since Crinesity is a 'class of one,' many health plans may continue to cover it as a non-formulary product rather than conduct a formal review. He highlighted that reimbursement has been surprisingly fast, with over 75% of dispensed prescriptions being paid for, minimizing the need for the free goods program. Consequently, he does not expect to provide formulary coverage statistics as a key metric.

Corinne Johnson from Goldman Sachs inquired about the expected cadence of research and development (R&D) spending as the Phase 2 trials in Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD) increase enrollment.

Answer

CFO Greg Weaver clarified that the costs for the AUD and ALD trials are modest, already incorporated into the current budget and cash runway, and are not expected to cause any unusual changes to the company's burn rate in the near term.

Corinne Johnson inquired about the implications of Roux-en-Y surgery's prevalence on Avexatide's potential label and market, and how recent trends in bariatric surgery types might affect the PBH incidence rate.

Answer

Co-CEO & Co-Founder Josh Cohen explained that while the Phase III trial focuses on Roux-en-Y for consistency, the drug's mechanism should work across surgical types, supported by Phase IIb data. He noted that after a period of decline, Roux-en-Y is regaining popularity versus sleeve gastrectomy due to better long-term weight loss outcomes.

Corinne Johnson requested context for the 30% first and second-line usage figure by asking for the prior period's metric, and inquired about the leading indicators being monitored to track the impact of the expanded sales force.

Answer

Jim Ziegler, EVP & CCO, clarified the 30% figure is from IQVIA's rolling three-month claims data, using a consistent methodology, but did not provide a comparative number from the prior period. He stated that leading indicators for the sales team's impact include regional sales performance and execution metrics like call reach and frequency on target physicians.

Corinne Johnson of Goldman Sachs inquired about the expected pace and peak potential for subcutaneous conversion in neurology launches compared to oncology. She also asked for details on the high-volume auto-injector human factor study and if such studies will become a standard prerequisite for future partnerships.

Answer

President and CEO Dr. Helen Torley expressed expectations for a robust conversion for drugs like OCREVUS in neurology, driven by the strong value proposition of a 10-minute injection versus a multi-hour IV infusion. Regarding the auto-injector, Dr. Torley explained that human factor studies are straightforward usability tests that may be used by some partners to optimize device design before clinical trials, but it will be a mix depending on the partner's needs.

Eric on behalf of Corinne Johnson at Goldman Sachs asked about the net price evolution for Wakix during the quarter and for the remainder of the year, and whether price is being used as a lever to drive volume.

Answer

CFO & CAO Sandip Kapadia explained that net price follows a predictable annual pattern, being lowest in Q1 due to insurance resets and then improving throughout the year. He confirmed that Q2 saw this expected improvement and that the trend should continue, allowing the company to realize a good portion of the list price increase taken earlier in the year.

Asked about the long-term sales force strategy, specifically if the planned 2025 expansion will be sufficient for the MDD opportunity or if further expansions are likely.

Answer

The company expects that after the 2025 expansion, the sales force will be appropriately sized to optimize the MDD launch and be highly competitive. While they will always reevaluate based on market conditions, the current plan is for next year's expansion to get them to the right size.