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    Joseph Stringer • Needham & Company

    Joseph Stringer's questions to Vir Biotechnology Inc (VIR) leadership

    Joseph Stringer's questions to Vir Biotechnology Inc (VIR) leadership • Q2 2025

    Question

    Joseph Stringer from Needham & Company asked for the rationale behind the 12-week deferred treatment period in the ECLIPSE-1 trial, compared to a competitor's 24-week period, and its potential impact on trial success.

    Answer

    EVP & Chief Medical Officer Dr. Mark Eisner explained that a 12-week deferred treatment arm is sufficient because spontaneous viral clearance in untreated HDV patients is essentially zero, a point agreed upon by the FDA and EMA. He stated this shorter duration is a more patient-friendly design, as it reduces the waiting time for patients randomized to the deferred arm to receive active treatment. He concluded that from a probability of success standpoint, a 12-week period is equivalent to a 24-week period.

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    Joseph Stringer's questions to Vir Biotechnology Inc (VIR) leadership • Q1 2025

    Question

    Joseph Stringer asked if there have been any recent changes to U.S. guidelines for HDV diagnosis, such as reflex testing, following VIR's updated patient estimates. He also inquired about the potential impact such changes could have on the addressable patient population.

    Answer

    Marianne De Backer (Executive) confirmed that there have been no changes to U.S. guidelines for reflex testing yet, but awareness is increasing. Mark Eisner (Executive) added that the current prevalence is likely underestimated due to this lack of testing and that he expects an approved, effective therapy would naturally drive more diagnoses, thereby increasing the identified patient population.

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    Joseph Stringer's questions to Vir Biotechnology Inc (VIR) leadership • Q4 2024

    Question

    Joseph Stringer of Needham asked for details on the Alnylam collaboration for elebsiran, specifically regarding the cost-profit share, Alnylam's optionality, and whether this is factored into cash burn assumptions. He also questioned how this agreement impacts potential partnership negotiations for the HBV program.

    Answer

    CEO Dr. Marianne De Backer clarified the Alnylam agreement is a financial arrangement where Alnylam has an option to either co-fund 50% of elebsiran costs for commensurate profit or opt-out for milestones and royalties. She stated this does not preclude a larger partner from taking an operational role in the HBV program. CFO Jason O'Byrne added that the company's cash runway guidance assumes the 'worst case' of Alnylam opting out, meaning an opt-in would be a potential upside.

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    Joseph Stringer's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership

    Joseph Stringer's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q1 2025

    Question

    Joseph Stringer from Needham & Company asked for the specific number of written and reimbursed prescriptions for IMCIVREE in the U.S. during the first quarter.

    Answer

    David Meeker, CEO, stated that the company is no longer breaking out those specific numbers. He explained that while they provided them initially to give a sense of the launch, they now rely on reported revenues as a more holistic measure of market performance.

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    Joseph Stringer's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q4 2024

    Question

    Joseph Stringer asked about the potential impact of including younger (4-6 years) and older (>40 years) patients in the Phase III HO trial on the primary BMI endpoint, compared to the Phase II population.

    Answer

    CEO David Meeker stated he expects no significant impact from either age group. He noted that the difference between a 4 and 6-year-old is negligible and that French early access data showed older adults respond very well, even years after their initial injury. He also highlighted that BMI change doesn't capture improvements in body composition.

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    Joseph Stringer's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q3 2024

    Question

    Joseph Stringer asked about the commercial opportunity for hypothalamic obesity (HO) in Japan and whether Rhythm can manage it independently. He also inquired about the profile of new-to-drug Bardet-Biedl syndrome (BBS) patients at this stage of the launch.

    Answer

    Chairman, CEO and President David Meeker expressed increased optimism for the Japan opportunity, expecting to complete enrollment of the 12-patient cohort by year-end, and affirmed the company's plan to 'go it alone.' EVP, Head of North America Jennifer Chien explained that new BBS patients are a mix, identified through ongoing physician education which makes them more adept at diagnosing patients, leading to growth from both first-time and repeat prescribers.

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    Joseph Stringer's questions to Apellis Pharmaceuticals Inc (APLS) leadership

    Joseph Stringer's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q4 2024

    Question

    Joseph Stringer from Needham & Company asked about the switching dynamics between SYFOVRE and its competitor, IZERVAY, and about patient compliance rates.

    Answer

    EVP of Commercial David Acheson noted that Apellis saw a number of patient switches to SYFOVRE, particularly during the competitor's CRL period, and that the continued growth in injections supports this trend. He reiterated that SYFOVRE's compliance rate is positive and in line with that of anti-VEGF therapies.

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    Joseph Stringer's questions to Vaxcyte Inc (PCVX) leadership

    Joseph Stringer's questions to Vaxcyte Inc (PCVX) leadership • Q4 2024

    Question

    Joseph Stringer from Needham & Company asked about the likelihood of Vaxcyte's candidates not receiving a preferred recommendation from ACIP and whether the company's outlook on this has been affected by the new administration.

    Answer

    CEO Grant Pickering expressed high confidence in securing a preferred recommendation. He argued that VAX-31's profile in adults (broader coverage, higher immune responses) is what ACIP was looking for, and in infants, their candidates address the specific issue of diminished immune response that prevented a preferred recommendation for PCV20. He emphasized that these decisions are historically based on the scientific merits of a vaccine, making it the primary factor regardless of administration changes.

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