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    Allison Bratzel • Piper Sandler

    Allison Bratzel's questions to Codexis Inc (CDXS) leadership

    Allison Bratzel's questions to Codexis Inc (CDXS) leadership • Q2 2025

    Question

    Allison Bratzel from Piper Sandler Companies asked for more detail on the company's exploration of options to expand bandwidth for the ECO platform. She questioned how this affects near-term strategy, the decision between using CDMO partners versus building in-house GMP capabilities, and requested a summary of the company's IP position and competitive moat for Ecosynthesis.

    Answer

    CEO Stephen Dilly explained that the focus is on locking in early-phase projects and that the company is increasingly confident in its ability to handle much of the scale-up process in-house, including GLP and future GMP material. He stated that this approach strengthens their competitive position. Regarding IP, he highlighted a strong patent portfolio supplemented by crucial trade secrets and know-how, which incentivizes partners to work directly with Codexis long-term.

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    Allison Bratzel's questions to Codexis Inc (CDXS) leadership • Q1 2025

    Question

    Allison Bratzel of Piper Sandler asked for the key assumptions underlying the guidance for achieving cash flow positivity by year-end 2026, and how potential partnerships or an investment in an internal GMP facility might affect that timeline.

    Answer

    CEO Stephen Dilly clarified that the cash flow positivity target is based on organic growth and does not factor in a new GMP facility, which would require separate financing based on a visible flow of orders. CFO Georgia Erbez added that spending for a potential facility would be staged, with capital costs weighted to 2026 and operating costs coming later, minimizing near-term cash burn.

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    Allison Bratzel's questions to Codexis Inc (CDXS) leadership • Q4 2024

    Question

    Allison Bratzel asked for details on the guidance for achieving cash flow positivity by the end of 2026, including the assumed contribution from the ECO platform and how spending on a proprietary GMP facility might impact this timeline.

    Answer

    CFO Georgia Erbez explained that progress towards cash flow positivity will be driven by revenue growth, which is expected to ramp up in the second half of the year as new ECO and ligase contracts are executed. Regarding the GMP facility, she noted that plans are still being formulated, with more visibility expected by the summer. She indicated that the company's net loss is projected to decrease throughout the year as the revenue base expands.

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    Allison Bratzel's questions to Scholar Rock Holding Corp (SRRK) leadership

    Allison Bratzel's questions to Scholar Rock Holding Corp (SRRK) leadership • Q2 2025

    Question

    Allison Bratzel from Piper Sandler Companies inquired about FDA interactions beyond the CDMO issues, confidence in a broad label, and the receptiveness of U.S. payers to covering apitigramab on top of existing SMA therapies.

    Answer

    President of R&D Akshay Vaishnaw described the late-cycle FDA meeting as "exceptionally constructive." COO Keith Woods added that payer outreach is progressing positively, with payers impressed by the drug's durability data. He noted that a precedent for dual therapy exists, as over 20% of SMA patients already receive more than one treatment.

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    Allison Bratzel's questions to Scholar Rock Holding Corp (SRRK) leadership • Q1 2025

    Question

    Allison Bratzel inquired about the progress of discussions with U.S. and ex-U.S. payers regarding coverage for apitegromab as a combination therapy, and also asked for an update on interactions with the FDA amid general concerns about the agency.

    Answer

    CEO David Hallal outlined a value-based pricing strategy for the rare disease space. COO Keith Woods confirmed that early payer discussions have been positive, noting that payers already cover multiple SMN therapies. President of R&D Akshay Vaishnaw assured that interactions with the FDA are collaborative and on track for the September 22 PDUFA date, stating the agency remains focused on rare diseases.

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    Allison Bratzel's questions to Scholar Rock Holding Corp (SRRK) leadership • Q4 2024

    Question

    Allison Bratzel inquired about the upcoming SAPPHIRE data presentation at the MDA conference, asking what additional data points would be most meaningful. She also asked for clarity on the EMBRAZE study, specifically what level of lean mass preservation would be considered a success for advancing SRK-439 and what the company hopes to see on secondary endpoints like A1c.

    Answer

    Executive Jay Backstrom stated that the full SAPPHIRE data will highlight the consistency and totality of apitegromab's effect across various endpoints and age groups. Regarding EMBRAZE, he explained that a 20% to 40% reduction in lean mass loss, which translates to preserving 1-2 kilograms, would be a meaningful signal to advance SRK-439. He noted this is a snapshot at 24 weeks and the effect could deepen over a full 52-week study.

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    Allison Bratzel's questions to BioMarin Pharmaceutical Inc (BMRN) leadership

    Allison Bratzel's questions to BioMarin Pharmaceutical Inc (BMRN) leadership • Q2 2025

    Question

    Allison Bratzel of Piper Sandler asked for clarification on what is gating the start of the BMN-333 dose-ranging trial and about the company's confidence in achieving regulatory alignment outside the United States.

    Answer

    Gregory Friberg, EVP and Chief R&D Officer, stated that the primary gating factor is the formal completion of the current Phase 1 healthy volunteer study, which is required for regulatory submissions to begin the next phase. He expressed excitement to share that BioMarin has already achieved regulatory alignment with multiple global agencies for the Phase 2/3 plans, and the study initiation is on track for the first half of next year.

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    Allison Bratzel's questions to Replimune Group Inc (REPL) leadership

    Allison Bratzel's questions to Replimune Group Inc (REPL) leadership • Q4 2025

    Question

    Allison Bratzel from Piper Sandler asked for an update on the confirmatory IGNYTE-3 trial's enrollment and timelines, as well as expectations for the breadth of the RP1 label.

    Answer

    CEO Sushil Patel reported that the IGNYTE-3 trial is enrolling well, with a current focus on U.S. sites ahead of the PDUFA date, followed by an expansion to ex-U.S. sites. He expressed confidence in achieving a broad label for RP1, as the IGNYTE study enrolled a real-world population and showed consistent benefit across all subgroups, which he expects the final label to reflect.

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    Allison Bratzel's questions to Ardelyx Inc (ARDX) leadership

    Allison Bratzel's questions to Ardelyx Inc (ARDX) leadership • Q1 2025

    Question

    An analyst on behalf of Allison Bratzel from Piper Sandler requested an update on the Kidney PATIENT Act and the company's strategy for acquiring or in-licensing external assets.

    Answer

    CEO Michael Raab characterized the Kidney PATIENT Act as a "free call option," confirming their $750 million XPHOZAH peak sales forecast does not depend on it. He also affirmed that a dedicated team is actively pursuing business development opportunities in renal, GI, and adjacent areas to build the company, with news to be shared when available.

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    Allison Bratzel's questions to Abcellera Biologics Inc (ABCL) leadership

    Allison Bratzel's questions to Abcellera Biologics Inc (ABCL) leadership • Q3 2024

    Question

    Allison Bratzel of BofA Securities inquired about the competitive landscape for AbCellera's ABCL575 program, particularly in light of recent data from competitors, and sought the company's view on the advantages of its OX40 ligand-targeted approach in atopic dermatitis.

    Answer

    President and CEO Dr. Carl Hansen explained that recent competitor data reinforces their view that non-depleting OX40 ligand antibodies are the leading approach. He differentiated ABCL575 as a non-depleting antibody engineered for a best-in-class profile, contrasting it with depleting antibodies like rocatinlimab. Dr. Hansen expressed strong confidence in the program's potential in atopic dermatitis and other indications, noting plans to present preclinical data next year.

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