Ashwani Verma

Ashwani Verma asked about the potential impact of first-generation generic market formation on LUMRYZ, whether indirect pricing pressure similar to XYWAV would apply, and if LUMRYZ holds a competitive advantage.

Answer

Todd Nichols, Chief Commercial Officer, asserted LUMRYZ's significant advantage as the only once-nightly oxybate, emphasizing its clear strategic positioning. He clarified that multi-source generics are specific to Xyrem and not interchangeable with LUMRYZ. Payer access for LUMRYZ remains strong (over 90% commercial), with no material changes observed, though potential impacts would likely be in the second half of the year. Sleep specialists are committed to ensuring patient access.

Ashwani Verma asked about the potential impact of first-generation generic oxybates on LUMRYZ, specifically whether indirect pricing pressure on XYWAV would replicate on LUMRYZ, or if LUMRYZ's once-nightly advantage would differentiate it.

Answer

Todd Nichols, Chief Commercial Officer of Alkermes, believes LUMRYZ has a significant advantage as the only once-nightly oxybate, which is not interchangeable with Xyrem generics. He noted strong payer access (over 90% commercial) with no material changes yet, expecting any impact from generics to be in the second half of the year or later.

Ashwani Verma from UBS Group asked about the specific time of day patients were dosed and whether the statement of no visual disturbance signal was based on AEs reported both during and outside of scheduled exams.

Answer

Marcus Yountz, VP of Clinical Development, stated that patients were instructed to take the dose in the morning around 8 AM. Richard Pops, Chairman & CEO, reiterated that specific AE data tables would not be available until the safety database closes in mid-August, with a full presentation at World Sleep in September.

Ashwani Verma questioned the company's commentary on stable inventory, suggesting a disconnect between reported sales and prescription script growth, and asked if there was any inventory build for LYBALVI, ARISTADA, or VIVITROL.

Answer

CCO Todd Nichols reiterated that inventory dynamics were consistent with expectations. He acknowledged that inventory for LYBALVI continues to grow modestly but stated this growth is consistent with and necessary to support the strong underlying demand and TRx growth. He concluded that inventory for both ARISTADA and LYBALVI is considered stable.

Ashwani Verma asked about the rationale behind Axsome's significant sales force expansion from 300 to 600 representatives, and sought guidance on the appropriate range for 2026 SG&A models, given consensus estimates of only 15% year-over-year growth.

Answer

Ari Maizel, Chief Commercial Officer, explained that the sales force expansion is designed to accelerate MDD growth and provide scale for potential ADA approval, increasing reach and frequency to high-value HCPs across primary care, psychiatry, and neurology. Mark Jacobson, Chief Operating Officer, noted that in 2025, revenues grew approximately three times faster than OpEx, and despite the expansion and DTC investments, Axsome expects to see continued operating leverage throughout 2026.

Ashwani Verma asked about the rationale behind the significant sales force expansion (from 300 to 600 reps) and sought guidance on the appropriate SG&A range for models in 2026, given consensus estimates of only 15% year-over-year growth.

Answer

Ari Maizel (Chief Commercial Officer, Axsome Therapeutics) explained that the sales force expansion is designed to accelerate MDD growth and provide scale for potential ADA approval, increasing reach and frequency to high-value HCPs across specialties, particularly primary care, psychiatry, and neurology. Mark Jacobson (COO, Axsome Therapeutics) added that in 2025, revenues grew roughly 3x faster than OpEx, and despite the expansion and DTC, operating leverage is expected to continue into 2026, with the team building in Q1/Q2.

Ashwani Verma sought to understand the discrepancy between Auvelity's 15% sequential prescription growth and its 24% net sales growth, asking if inventory was the primary driver.

Answer

Chief Financial Officer Nick Pizzie explained that the difference was due to three factors: a slight improvement in the gross-to-net percentage (while still in the mid-50s range), an increase in inventory value due to higher demand (while still at the two-week level), and a small, favorable change of estimate from a prior quarter's liability accrual.

Ashwani Verma of UBS asked how pursuing a supplemental NDA (sNDA) for AXS-05 in Alzheimer's disease agitation, rather than a new NDA, could impact the product's commercial potential, particularly concerning its gross-to-net (GTN) discount, which might be consolidated with the depression indication.

Answer

Ari Maizel, Chief Commercial Officer, explained that the sNDA pathway provides promotional clarity under the Auvelity brand name. He viewed this as beneficial, suggesting that existing payer familiarity with the product could facilitate access for the new indication. He did not see the GTN aspect as a necessary negative and expressed confidence in the commercial advantages of this strategy.

Ashwani Verma asked if cabozantinib's RCC revenue grew in Q4, given strong net growth and gross-to-net improvement, and what median PFS delta versus cabozantinib's prior 10 months in LITESPARK-011 data could impact near-term RCC sales.

Answer

P.J. Haley (EVP of Commercial, Exelixis) confirmed strong business momentum and 15% TRX growth year-over-year in Q4, driven by both RCC and NET. He reiterated expectations for continued growth in both franchises in the current year, as indicated by guidance.

Ashwani Verma asked if RCC grew for CABO in Q4, given strong net growth and gross-to-net improvement. He also inquired about the median PFS delta needed from LITESPARK-011 data to impact RCC sales, relative to CABO's prior 10 months.

Answer

P.J. Haley (EVP of Commercial) confirmed strong business momentum and 15% TRX growth year-over-year in Q4, driven by both RCC and NET. He reiterated expectations for continued growth in both franchises in the current year.

Ashwani Verma asked about Exelixis' assumption for the market share of TAS plus bevacizumab in the third-line colorectal cancer market by the time Zanzalintinib plus Atezolizumab enters, given that TAS plus bevacizumab is perceived as a growing segment. He also asked if the subtle differences in the SUNLIGHT study regarding prior bevacizumab exposure have slowed its adoption.

Answer

PJ Haley, Executive Vice President of Commercial, stated that market research indicates the share of the SUNLIGHT regimen has been relatively stable, not growing, and that the fragmented market presents a significant opportunity for Zanza/Atezo. He highlighted extensive physician feedback suggesting Zanza/Atezo will gain uptake from all competitors, and mentioned the expansion of the sales force to enhance reach in the community setting for this common tumor type.

Ashwani Verma from UBS asked if the positive ITT data from the STELLAR-303 trial could be presented at a medical conference this year, even while the final analysis for the second primary endpoint is still pending.

Answer

EVP & CMO Amy Peterson did not commit to a specific venue but confirmed they will share the data once abstract titles are public. She also affirmed that the company has a precedent for presenting positive results from one primary endpoint while another is still maturing.

Ashwani Verma asked for more detail on the NET launch dynamics, specifically from which existing therapies uptake would come and how CABOMETYX would compete with or be sequenced around Lutathera.

Answer

EVP of Commercial P.J. Haley reiterated that based on the unique and broad dataset, they expect CABOMETYX to be used broadly across lines of therapy and sites of origin. He stated the company's goal is to establish it as the small molecule leader within its approved indication, implying competition with other oral therapies.

Ashwani Verma asked if the efficacy level shown for zanzalintinib plus atezolizumab in CRC at ASCO GI is sufficient to support the company's broader peak sales guidance for the drug.

Answer

Chief Medical Officer Amy Peterson stated that the company is encouraged by the data, noting that the observed overall survival of 11.7 months 'bodes well' against the 6.5-7.5 months seen with regorafenib. She also highlighted strong survival data in the non-liver met population, while cautioning that a large, randomized Phase III study is required for confirmation.

Ashwani Verma questioned the company's capital allocation priorities, asking why the focus is on share buybacks now that IP uncertainty is resolved, rather than deploying most capital towards pipeline development.

Answer

President and CEO Michael Morrissey responded that with the company's strong cash flow and commitment to disciplined spending, it can pursue all priorities simultaneously. This includes investing in the pipeline, executing business development, and returning cash to shareholders.

Ashwani Verma asked about Roivant's confidence in batoclimab's upcoming TED results given recent setbacks in the field, and whether a positive Graves' disease readout would translate to TED success.

Answer

CEO Matt Gline stated that the TED studies are ongoing, and data will be released when available. He emphasized that there is not much read-through from TED to Graves' disease, as the diseases are different, and the TED study enrolled mostly euthyroid patients, while Roivant has strong Phase 2 data in Graves' disease.

Ashwani Verma, Research Analyst at UBS, asked about Roivant's confidence in batoclimab's upcoming TED results, considering recent setbacks in the field, and whether a positive Graves' disease readout would translate to success in thyroid eye disease.

Answer

Matt Gline, CEO of Roivant Sciences, stated that the TED studies are ongoing, and data will be released when available. He emphasized that batoclimab's activity in hyperthyroidism from phase 2 Graves' data suggests efficacy in both indications, but the diseases are fundamentally different, with TED studies enrolling mostly euthyroid patients. He does not see significant read-through from TED to Graves' disease.

Ashwani Verma asked about the upcoming batoclimab TED results in light of Vyvgart's recent setback in TED, and Roivant's confidence that a positive Graves' disease readout would translate to success in thyroid eye disease.

Answer

Matt Gline, CEO of Roivant, stated that batoclimab's TED data is forthcoming, and the drug is known to be active in hyperthyroidism. He emphasized that there is little read-through from Vyvgart's TED setback to batoclimab's Graves' disease program, as the diseases and patient populations in the studies are fundamentally different.

Ashwani Verma asked about batoclimab's upcoming TED results in light of the recent Vyvgart setback in TED, and Roivant's confidence that a positive Graves' disease readout would translate to success in thyroid eye disease.

Answer

Matt Gline, CEO of Roivant, stated that TED data is coming, and batoclimab is known to be active in hyperthyroidism. He doesn't see much read-through from Vyvgart's TED setback to Graves' disease, as the diseases and patient populations (TED study enrolled mostly euthyroid patients) are fundamentally different. He is confident in FcRns for Graves' disease.

Ashwani Verma of UBS questioned Teva's R&D funding strategy, specifically how it balances giving away attractive economics through partnerships versus increasing internal R&D spend for its growing pipeline. He also sought expectations for the upcoming TL1A maintenance data, particularly regarding efficacy measures compared to induction data.

Answer

CEO Richard Francis explained that partnerships do not significantly dilute economics due to the high gross margins of innovative products and the accelerated value creation from rapid market entry. Head of R&D Eric Hughes expressed strong confidence in the TL1A maintenance data, citing the drug's potency, selectivity, low anti-drug antibodies, and robust Phase 2 results.

Ashwani Verma from UBS Group AG asked for a timeline on AUSTEDO's BID to XR conversion across all patients and sought more clarity on the impact of tariffs, particularly the mentioned exclusion of certain generics.

Answer

President and CEO Richard Francis noted that the AUSTEDO XR conversion will be gradual as stable patients may not be switched, but the trend is clear. On tariffs, he and EVP & CFO Eli Kalif reiterated that there is too much uncertainty to comment on specific generic exclusions and that confirmed tariffs are already factored into the 2025 guidance with no meaningful short-term impact expected from new European rules.

Ashwani Verma asked about the dynamic between CARVYKTI's utilization in the second to fourth line settings, specifically the prominence of the third line, and the anticipated early impact of the MAJESTY-3 data on the second-line opportunity for CARVYKTI.

Answer

Alan Bash, President of CARVYKTI, stated that while all lines of therapy are growing, approximately 60% of scripts come from earlier lines (second through fourth), with the third line showing the most pronounced growth. Ying Huang, CEO, expressed pleasure about a potential new regimen from MAJESTY-3, noting the large addressable market and CARVYKTI's unique profile of unmatched survival, durability, and one-time treatment convenience, thus not expecting MAJESTY-3 to impact CARVYKTI's second-line uptake.

Ashwani Verma asked for a breakdown of the second to fourth-line dynamic for CARVYKTI, specifically the prominence of the third line, and the potential impact of MAJESTY-3 data on CARVYKTI's second-line opportunity.

Answer

Alan Bash, President of CARVYKTI, declined to break down the exact split but noted that all lines are growing, with the third line showing the most pronounced growth, leading to a 60/40 split between earlier (2-4) and later (5+) lines. Ying Huang, CEO, welcomed MAJESTY-3 as another regimen for second-line patients in a large market, not expecting it to impact CARVYKTI's second-line uptake due to its unmatched survival data, durability, and one-time treatment convenience.

Ashwani Verma asked about the ramp of Novartis's commercial supply in the second half, the potential for CARTITUDE-V data in calendar year 2026, and the possibility of seeing data from CARTITUDE-II cohorts E and F later this year.

Answer

Alan Bash, President of CARVYKTI, clarified that the Novartis supply has been ramping since its approval and is expected to reach full capacity by year-end, contributing to growth throughout the second half. Interim CFO Jessie Yeung reiterated that CARTITUDE-V is event-driven and declined to comment on data timelines or future conference submissions for CARTITUDE-II.

Ashwani Verma of UBS questioned if the Q2 sales step-up from new Novartis supply would be as significant as the growth seen in Q3 of the prior year and asked for thoughts on potential neurotoxicity data from a competitor.

Answer

Alan Bash, President of CARVYKTI, projected a modest step-up in Q2 with further acceleration in the second half of the year, noting strong Q1 performance was partly due to faster-than-expected ramping at the Obelisc facility. Chief Medical Officer Mythili Koneru declined to comment on competitor data but highlighted excitement for Legend's own long-term CARTITUDE-1 data at ASCO and the successful implementation of safety monitoring protocols.

Ashwani Verma asked when the Novartis commercial manufacturing facility will begin to provide a meaningful benefit and what percentage of capacity it will represent. He also questioned how the ALC monitoring protocol from the Tandem data would be adopted in the community setting and if it could be a hurdle.

Answer

Executive Alan Bash said that with the recent approval, the Novartis facility is expected to start contributing meaningfully in the second quarter of the year, though a specific capacity percentage was not provided. Executive Jessie Yeung addressed the second question, explaining that ALC is a common lab test and low-dose steroids are inexpensive and readily available, making the mitigation strategy easily adoptable in both academic and community settings without significant resistance.

Ashwani Verma asked about the order of priority for cost savings in the strategic review (commercial, R&D, operations). He also asked CFO Doretta Mistras about the pushes and pulls for 2026 top-line revenue, considering the lapsing $350 million FX tailwind from 2025 and new product contribution potential.

Answer

CEO Scott Smith clarified that Viatris is not ranking the quantum of savings publicly yet, emphasizing the project's complexity. He noted that the largest quantum could come from sourcing, manufacturing, supply chain, and inventory optimization. CFO Doretta Mistras stated that underlying positive fundamentals are expected to continue into 2026, with revenue drivers including commercial performance, new product approvals/uptake, North America competitive dynamics, and potential Amitiza LOE in Japan. Scott Smith expressed confidence in 2026 new product revenue.

Ashwani Verma from UBS asked about the drivers of the strong China performance and the focus of BD efforts there, as well as the scope, timeline, and potential for cost optimization from the enterprise-wide strategic review.

Answer

CCO Corinne Le Goff attributed the 9% China growth to a diversified commercial model and customer buying patterns, expecting it to moderate to low-to-mid single digits. CEO Scott Smith confirmed China is an active area for BD. Regarding the strategic review, Smith stated it covers all aspects of the business to improve efficiency, expects significant cost savings, and aims to provide detailed granularity on the Q3 earnings call.

Ashwani Verma from UBS asked about the company's appetite for more aggressive share repurchases given the stock price and sought specifics on meloxicam's onset of action and the potential for a 'fast-acting' label claim.

Answer

CEO Scott Smith and CFO Theodora Mistras confirmed their commitment to the existing $500-$650 million share repurchase plan but noted they retain strategic flexibility to potentially increase it, given market volatility. Chief R&D Officer Philippe Martin provided data showing a rapid onset of pain relief for meloxicam but stated he could not speculate on a specific FDA label claim.

Ashwani Verma of UBS inquired about the implications of the Indore warning letter for 2026, particularly regarding offsets for the accelerated loss of lenalidomide revenue, and questioned why the company was not planning a more aggressive share buyback given the stock's pre-market decline.

Answer

CEO Scott Smith explained that the lenalidomide financial impact was an event expected for early 2026 that has been pulled forward by 10-12 months. He characterized the guided $500M-$650M share repurchase for 2025 as a minimum, stating the company has flexibility to be more aggressive and will evaluate doing so if the stock remains under pressure, balancing it with accretive business development.

Ashwani Verma of UBS asked how Viatris plans to balance business development investments with share repurchases, given that debt paydown targets are nearly met and the stock is trading at a low valuation. He also inquired when the supply chain impacts on the ARV business in emerging markets would be resolved.

Answer

CEO Scott Smith confirmed that reaching their leverage target allows for a balanced capital allocation strategy, but noted that given the current stock valuation, Viatris may be 'more aggressive on the share buyback side' in 2025. CFO Theodora Mistras clarified that the recent ARV issue was due to specific supply delays, not therapy shifts, and the company is working to resolve the backlogs.

Ashwani Verma of UBS Group AG sought confirmation on whether the full-year 2025 revenue and EBITDA guidance ranges remain intact given the first-half performance. He also asked for projections on the U.S. market share dynamics for both Humira and Stelara biosimilars through the end of the year.

Answer

CEO Róbert Wessman confirmed that H1 results were in line with expectations and the company is not changing its guidance, reiterating that Q4 is expected to be the strongest quarter. CCO Anil Okay detailed market share performance, noting continued growth in Europe for Humira biosimilars, a top-three position in the U.S., and strong performance for the Stelara biosimilar in Europe with U.S. uptake proceeding as forecast.

Ashwani Verma from UBS sought a clarification on the 1 million units of the HUMIRA biosimilar mentioned in the prepared remarks, asking if the unit of measure was pens.

Answer

Chief Commercial Officer Anil Okay confirmed that the binding purchase orders for over 1 million units are indeed measured in pens.

Ashwani Verma of UBS Group asked whether the pushout of the late-cycle meeting to September was a direct result of the PDUFA extension or a separate development that could cause further delays.

Answer

President and CEO Robert Blum confirmed the later meeting date is consistent with the three-month PDUFA extension and is not a separate development. He stated they have no reason to believe there are other issues and that interactions with the FDA indicate the review is proceeding toward the new PDUFA date.

Ashwani Verma asked about the timeline for NUPLAZID's eligibility for IRA price negotiation. He also questioned if the ACP101 formulation, which requires refrigeration and thrice-daily dosing, could be a hindrance and if a room-temperature stable version is planned.

Answer

CFO Mark Schneyer projected that 2029 would be the first year NUPLAZID is eligible for IRA negotiation, with a potential one-year delay if the 'pill penalty' is removed. EVP, Head of R&D, Elizabeth Thompson, explained that the current ACP101 formulation is being used to maintain consistency for the FDA resubmission and has been acceptable in trials. She added that the company is always considering next-generation, patient-friendly product improvements.

Ashwani Verma of UBS questioned the company's confidence in the low-dose carbetocin (ACP-101) data, given a prior trial showed an inverse dose relationship, and also asked for the company's perspective on the use of GLP-1s in Prader-Willi syndrome.

Answer

An executive, likely Head of R&D Elizabeth Thompson, detailed that confidence in the 3.2mg dose stems from its mechanistic rationale, internal consistency in prior data, and a plausible hypothesis that off-target effects at the higher dose obscured the benefit. Regarding GLP-1s, she stated that their utility in the Prader-Willi patient population remains unproven.

Ashwani Verma of UBS Group AG asked for Royalty Pharma's perspective on the competitive landscape for biopharma royalties, particularly how the scaling up of competitors like Healthcare Royalty Partners (acquired by KKR) impacts its ability to win large transactions.

Answer

CEO Pablo Legorreta stated that the company welcomes competition and emphasized Royalty Pharma's significant advantages, including its unique integrated structure, very low cost of capital, massive scale for multi-billion dollar deals, an experienced team, and deep industry relationships, which allow it to win desirable assets.

Ashwani Verma sought clarification on the 2025 guidance for operating and professional costs, asking if the 10% figure reflects the internalization and how the previously mentioned $100 million in savings is calculated. He also asked if the Alyftrek royalty dispute needs to be resolved before the first royalty payment becomes due.

Answer

EVP and CFO Terrance Coyne confirmed the 10% operating cost guidance does not yet reflect the internalization and that the post-internalization run-rate is expected to be around 4-5%, which accounts for the savings. Regarding the Alyftrek royalty timing, he reiterated that he could not provide any specific details on a resolution timeline.

Ashwani Verma questioned whether Nictimbo's intravenous (IV) administration could become a bottleneck for adoption, considering that many chronic GVHD patients are treated in an outpatient setting.

Answer

Marshall Urist, EVP, Head of Research and Investments, acknowledged that the IV administration was factored into their forecasts. However, he stressed that for patients who have already failed existing oral therapies and carry a significant symptom burden, the high unmet need makes Nictimbo a critical and compelling option, which should drive adoption despite the administration route.

Ashwani Verma of UBS Group questioned the implications of focusing the Fragile X trial on the 'full methylation' patient subgroup, asking about the size of this population and for regulatory precedents where the FDA accepted data from a similar genetically-defined subgroup.

Answer

Chief Medical & Scientific Officer Dr. Kumar Budur explained that fully methylated patients comprise 60-70% of the Fragile X population and have a higher symptom burden, aligning with ZYN-two's mechanism. He confirmed extensive discussions and full alignment with both the FDA and EMA on this targeted approach. President & CEO Dr. Jeffrey Dayno reiterated that the strategy follows both the science and the data from the prior study.

Ashwani Verma asked for thoughts on Shionogi's competing Fragile X program and its different endpoint, and also requested a breakdown of new WAKIX patients by prior oxybate experience.

Answer

Dr. Kumar Budur, CMSO, differentiated their program by noting it targets neurobehavioral symptoms prevalent in all Fragile X patients, unlike the competitor's focus on cognition in a subset of males. CCO Adam Zaeske explained that most new patients have prior therapy experience due to the market's polypharmacy nature. CEO Dr. Jeffrey Dayno added that concomitant WAKIX and oxybate use has been stable at 10-15%.

Ashwani Verma asked about emerging literature suggesting orexin agonists might accelerate Alzheimer's pathology and whether this is a concern for Harmony's program or the FDA.

Answer

Dr. Kumar Budur, Chief Medical and Scientific Officer, stated the concern was linked more to orexin 1 receptors and the effects of sleep deprivation itself, not the agonist. He clarified that this has not been observed in their preclinical models or in data from other ongoing clinical trials, and he does not consider it a current concern.

Ashwani Verma asked about the rationale for including non-complete methylation patients in the ZYN-002 RECONNECT study and inquired about potential inventory build given the divergence in sequential revenue and patient growth.

Answer

Chief Medical and Scientific Officer Dr. Kumar Budur explained that while the primary endpoint for ZYN-002 is in complete methylation patients, the inclusion of partially methylated patients was based on FDA discussions and could support a broader label. CFO Sandip Kapadia stated there was no significant inventory build, attributing the stronger revenue growth to typical second-half improvements in gross-to-net deductions.

Ashwani Verma of UBS Group asked about the typical duration of reimbursement authorizations for Crinesity and whether reauthorization requires demonstrating a specific level of steroid dose reduction.

Answer

CCO Eric Benevich stated that initial authorizations are typically for six or twelve months. For reauthorization, plans generally require the provider to affirm that the patient is benefiting from treatment, rather than mandating specific lab results or a hard threshold for glucocorticoid dose reduction. He described the reauthorization process as being as smooth as the initial authorization.

Ashwani Verma asked about the timing of the benefits from new INGREZZA Medicare contracts and requested a reminder of the sales force expansion size and when its impact would be realized.

Answer

Chief Commercial Officer Eric Benevich stated that pull-through efforts for the new formulary access began in April and primarily benefit new patient starts, and that the 'substantial' sales force expansion is now showing tangible benefits. CFO Matthew Abernethy clarified the financial timing: the negative gross-to-net impact is immediate in Q2, while the positive revenue impact from new patients will accrue over several quarters.

Ashwani Verma asked if the utilization management headwinds for INGREZZA are expected to worsen in 2025 for Medicare Part D plans due to the Inflation Reduction Act (IRA) causing plans to tighten controls.

Answer

Chief Commercial Officer Eric Benevich stated that they do not expect significant changes to INGREZZA's coverage in 2025 versus 2024. He also highlighted that Neurocrine has a 'small manufacturer' designation, which provides a phase-in benefit on the catastrophic coverage contribution under the IRA, a status shared by its competitor, so there is no relative disadvantage within the VMAT2 class.

Ashwani Verma of UBS asked for key learnings from the NBI-568 Phase II results, particularly regarding its orthosteric agonism, and the implications for the rest of the muscarinic pipeline.

Answer

CMO Eiry Roberts stated that the company is rapidly advancing NBI-568 into a Phase III registration program for schizophrenia in H1 2025, following encouraging Phase II data. She emphasized the potential for a selective agent to improve the benefit-risk profile in the space. She also noted the broader pipeline of M1 and M4 agonists will be evaluated for various indications as Phase I data becomes available.

Ashwani Verma from UBS Group AG inquired about the TETON study design, specifically how patient discontinuations are handled statistically and whether the known side effect of cough from Tyvaso could lead to functional unblinding of the trial.

Answer

Dr. C.Q. Deng, SVP of Biostatistics, and Dr. Leigh Peterson, VP of Product Development, both addressed the question. Dr. Deng noted that placebo patients also experience cough, mitigating unblinding risk. Dr. Peterson added that deaths are penalized with a low FVC value (2.5th percentile), while other discontinuations are handled through statistical models like MMRM or multiple imputation.

Ashwani Verma from UBS Group AG asked for an update on Tyvaso patient additions in recent quarters and for the company's expectations regarding Insmed's upcoming TPIP data and Tyvaso's competitive positioning against it.

Answer

President and COO Michael Benkowitz stated that the company no longer provides specific patient-add metrics for competitive reasons but advised that revenue trends are a good proxy for underlying demand. Regarding TPIP, he noted they await the data, while CEO Martine Rothblatt expressed confidence in retaining well-managed patients and highlighted UTHR's own preclinical once-daily NCE as part of its 'multiple shots on goal' strategy.

Ashwani Verma questioned the potential competitive impact from Merck's sotatercept (Winrevair) following the Hyperion study and whether Tyvaso could maintain its growth in the PAH market.

Answer

Michael Benkowitz, President and Chief Operating Officer, asserted that sotatercept is an additive therapy, not a replacement for prostacyclins, and is often used in combination. He believes the long-term impact will be immaterial because PAH is a progressive disease, and patients will ultimately require a prostacyclin, maintaining the company's long-term growth prospects.

Ashwani Verma, also known as Ash Verma, asked if the company remains on track for its $4 billion revenue run rate goal in 2025 and whether it has preemptively initiated rebating ahead of a competitor's launch.

Answer

Executive Martine Rothblatt expressed confidence in reaching future revenue milestones by maintaining double-digit annual growth. Executive Michael Benkowitz confirmed that new Part D payer contracts have been initiated, with all expected to be effective by January 1. He noted this positions the company favorably for future competition by having established rebate flows and parity language.

Ashwani Verma of UBS asked for clarification on the comment about one fewer shipping week, wanting to know if it affected specific products or the entire business.

Answer

Bruce Cozadd, Chairman and CEO, and Renée Galá, President and COO, both confirmed that the impact of having one fewer shipping week in the quarter was common across their U.S. oncology business.

Ashwani Verma from UBS asked for Incyte's view on the potential impact of upcoming competitor readouts in hidradenitis suppurativa (HS), such as canakinumab and Rinvoq, on the value proposition for povorcitinib.

Answer

Pablo Cagnoni, President, Head of R&D, reiterated his confidence that povorcitinib has a very competitive profile. He stated that based on the totality of the Phase II data—including efficacy across multiple HiSCR levels, pain response, and safety—povorcitinib is well-positioned against biologics and Rinvoq, even with an expected correction from Phase II to Phase III results.

Ashwani Verma of Bank of America sought clarification on the LianBio collaboration, asking about the launch timing in their territories relative to the U.S., the potential timing of milestone payments, and whether data from the open-label portion of the LYR-220 Phase 2 study would be publicly shared.

Answer

SVP Corinne Noyes clarified that the launch in China is planned to occur shortly after the U.S. launch, sooner than a year. CFO Jason Cavalier stated that specifics on milestone timing have not been disclosed. President and CEO Maria Palasis confirmed that Lyra would report out on the feasibility and safety data from the open-label part of the study, expecting to have it in the second half of 2022.

Ashwani Verma of Bank of America asked about any differences in inclusion/exclusion criteria between the Phase 2 and upcoming Phase 3 trials for LYR-210, the timing of milestone payments from LianBio, and the future run rate for operating expenses.

Answer

President & CEO Maria Palasis clarified that the Phase 3 trial will mirror the Phase 2 trial, with the main differences being a primary endpoint of three cardinal symptoms (instead of four) and the use of CT imaging instead of MRI. She stated that LianBio milestones are tied to clinical, regulatory, and commercial events without giving specific timing. CFO Don Elsey noted that Q2 G&A was not a new run rate due to episodic costs but that some non-material increases are expected.