Ash Verma

Ash Verma questioned Teva's R&D funding strategy, specifically how it balances giving away attractive economics through partnerships versus increasing internal R&D spend. He also asked about expectations for the upcoming TL1A maintenance data, comparing it to competitors' induction data.

Answer

CEO Richard Francis explained that partnerships accelerate value by bringing a large, high-value pipeline to market quickly, and that innovative products significantly transform Teva's gross margin. Head of R&D and CMO Eric Hughes expressed bullishness on Duvakitug's maintenance data, citing its in vitro potency, selectivity, low anti-drug antibodies, and strong phase II results in Ulcerative colitis and Crohn's disease.

Ash Verma asked about the Complete Response Letter (CRL) for Simponi, specifically inquiring if the observations were different from previous inspections, the status of resolution actions, and the strategic value of maintaining manufacturing in Iceland given past challenges. He also asked about the impact of two CRLs on customer conversations and contracting.

Answer

Joseph McClellan, Chief Operating Officer, clarified that the observations were not repeat observations and that Alvotech committed to over 180 changes, with 93% already completed. Róbert Wessman, CEO, emphasized the strategic importance of in-house R&D and manufacturing, noting successful FDA inspections in the past and the commonality of FDA observations in the pharmaceutical industry. He also stated that Alvotech has not seen any reduction in customer interest, maintaining strong relationships and keeping clients updated on quality system evolution.

Arsh Verma from UBS then asked about the commercial impact of receiving two Complete Response Letters (CRLs) for FDA approvals, specifically how this affects ongoing conversations with customers and contracting efforts for new products like Stelara and Simponi biosimilars.

Answer

Róbert Wessman, CEO, stated that Alvotech continues to see strong interest in its broad product portfolio. He mentioned that clients are aware of the facility status through their own audits and that the company keeps them updated on quality system evolution. He concluded that there has been no reduction in interest, with multiple partners showing strong interest in their portfolio products.

Ash Verma asked about the order of priority for potential savings within the strategic review, specifically if commercial, R&D, and operations were ranked, and the largest potential source. He also questioned the pushes and pulls for the 2026 top line, considering the lapsing FX tailwind and the target for new product contribution.

Answer

CEO Scott Smith clarified that while not providing specific quantum yet, the largest potential savings from the enterprise-wide review are expected from sourcing, manufacturing, supply chain, and inventory optimization, with significant contributions also from corporate support and commercial model evolution. CFO Doretta Mistras outlined 2026 revenue dynamics, including continued commercial performance in Europe, China, and emerging markets, timing of new product approvals, competitive dynamics in North America, and potential Amitiza LOE in Japan. She also noted positive momentum for new product revenues towards the $450M-$550M target. Scott Smith expressed confidence in the 2026 new product revenue.

Ash Verma asked about the colorectal cancer (CRC) market dynamic, specifically the growing share of TAS-102 plus bevacizumab, and if prior bevacizumab exposure is slowing the adoption of that regimen.

Answer

PJ Haley, EVP of Commercial, stated that market research indicates the share of the SUNLIGHT regimen (TAS-102 plus bevacizumab) has been relatively stable, not growing significantly. He noted that the fragmented third-line plus market, with one-third SUNLIGHT, one-third TKI, and one-third other therapies, presents a significant opportunity for Zanzalintinib, with research showing uptake from all competitors.

Ash Verma inquired whether the BiRCh study data is already in-house, given its primary completion in August, and the rationale for the early January readout timeline.

Answer

Will Lewis, Chairman and CEO of Insmed, and Martina Flammer, Chief Medical Officer, confirmed that data is collected almost in real-time, with the vast majority currently in the cleaning process. Martina emphasized taking the necessary time for database lock and cleaning to meet the highest regulatory standards, hence the early January target for readout.

Ash Verma asked about the current status of the BIRCH study data, specifically if it's already in-house, and the timeline for the early January readout, considering the primary completion was in August.

Answer

Will Lewis, Chairman and CEO, stated that the company is moving quickly to process and clean the data for a database lock, aiming for an early January readout to avoid holiday disruptions. Martina Flammer, Chief Medical Officer, confirmed that data is collected almost in real-time, with the vast majority in the cleaning process, and emphasized ensuring the highest regulatory standards for data lock and cleaning.

Ash Verma asked about the medium-term growth outlook for INGREZZA, inquiring if the company believes it can grow at a higher pace than this year's guidance in the years before the IRA impact, given the sales force investment and contracting.

Answer

Eric Benevich, Chief Commercial Officer, stated that the VMAT2 market is experiencing double-digit growth, and INGREZZA is growing faster than the market, with 12% year-over-year growth in Q3. He expressed confidence in continuing this strong, robust growth trajectory into 2026 and beyond, aiming to maximize patient share.

Ash Verma asked about the medium-term growth outlook for INGREZZA, inquiring if the company believes it can grow at a higher pace than the current year's guidance, given the sales force investment and contracting.

Answer

Eric Benevich, Chief Commercial Officer, stated that the VMAT2 market is experiencing double-digit growth, and INGREZZA is growing faster than the market, with 12% year-over-year growth in Q3. He expressed confidence in continuing this strong trajectory into 2026 and beyond, aiming to maximize patient share. He noted more color on 2026 projections would be provided during the Q4 earnings call.

Ash Verma asked if 989 could be pursued in first-line or naive patients in registration studies. He also inquired about the 989 formulation, specifically what volume it could be reduced to and if it could be a home subcutaneous injection.

Answer

President Pablo Cagnoni confirmed the full intent to develop 989 for first-line MF patients, with ongoing work on the combination with ruxolitinib in treatment-naive patients, noting preclinical data shows synergy. He stated the goal for 989's formulation is a device for at-home self-administration subcutaneously, which is the purpose of the ENABLE collaboration, aiming for a path in 2026.

Ash Verma asked for Incyte's expectations regarding the efficacy outcomes for the Phase III inMIND and frontMIND studies of Monjuvi (tafasitamab) in lymphoma.

Answer

Executive Steven Stein expressed encouragement for tafasitamab's profile, citing strong existing data in other lymphoma settings. For the event-driven first-line DLBCL study, he noted data is expected soon and that the drug's mechanism, which preserves CD19 expression, is a key attribute. He indicated a submission would follow rapidly after a positive result.

On behalf of Ash Verma at UBS, a question was asked about Avadel's confidence in preventing a competitor from blocking a future IH approval with another injunction. Further questions covered goals for the patient mix and the potential impact of generic entry in 2026 on market pricing.

Answer

CEO Gregory Divis expressed confidence, citing Avadel's track record of success in overcoming legal challenges and establishing LUMRYZ's clinical superiority. On patient mix, CFO Thomas McHugh reiterated the focus is on growing all patient segments. Regarding generics, Divis stated he expects minimal impact, similar to the current authorized generic, and believes LUMRYZ is well-positioned to capture patients who may be required to step-through a generic first.

Asked for details about the pipeline psychedelic, ITI-1500, including its origin, mechanism of action, and value proposition.

Answer

The ITI-1500 program was developed entirely in-house, leveraging the company's expertise in serotonin (5-HT2) biology. The molecules are 5-HT2A agonists designed to be non-hallucinogenic and to avoid the cardiovascular side effects associated with the drug class, which represents their key value proposition.

Ash Verma from Bank of America inquired about the design and success criteria for the pharmacokinetics (PK) study, the rationale for not providing specific 2021 financial guidance, and the scheduling status of the end-of-Phase 2 meeting with the FDA.

Answer

President & CEO Maria Palasis explained the PK study enrolled 24 patients at two dose levels to measure systemic drug levels, a requirement for the 505(b)(2) pathway, with results expected in Q2 2021. She also confirmed the company is in contact with the FDA and the end-of-Phase 2 meeting is planned to occur before the end of Q2. CFO Don Elsey clarified that providing a cash runway into 2023 was deemed more meaningful than specific 2021 spending guidance due to the variable timing of major clinical trial and tech transfer milestones.