Jennifer Kim • Cantor Fitzgerald

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CFO & Director Hao-Yuan Chuang explained that for the DRAGON trial, they aim to show a statistically significant difference in atrophic lesion growth rate, similar to approved GA drugs. For the PHOENIX trial, he stated the dropout rate is within the expected range and the design of the interim analysis has not yet been finalized.

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Chairman and CEO Dr. Tom Lin confirmed a meeting with the FDA has been scheduled and expressed no concern over regulatory risk from personnel changes. Chief Scientific Officer Dr. Nathan Mata elaborated on the DRAGON trial, stating it is powered to detect a 35% treatment effect. He highlighted the positive safety outlook, referencing the interim analysis which showed a low overall withdrawal rate of less than 10% and only 3.8% due to ocular adverse events.

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Chairman and CEO Dr. Tom Lin responded, expressing confidence that international regulators would likely align with the positive DSMB recommendation but affirmed the study would proceed as planned regardless. For the GA trial, Dr. Lin explained the sample size was increased to 'boost our chances of success' due to smooth enrollment, noting that positive interim results would expedite the launch of a second Phase III trial for GA.

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Chief Scientific Officer Nathan L. Mata stated the all-cause discontinuation rate in the PHOENIX trial is around 15%. He and executive Tom Lin explained that the DRAGON interim analysis is pending data cleaning and a DSMB meeting, which is contingent on appointing a new chair, with results expected by late 2024 or early 2025. For DRAGON 2, enrollment is underway and expected to be complete by Q2 of the following year.

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EVP & CCO Jeff Del Carmen reported that Firdapse's annual discontinuation rate was below 20% and the average daily dose increased by approximately 4mg, as expected. President & CEO Richard Daly confirmed Teva has 180-day exclusivity but explained the Fycompa guidance is a prudent position, accounting for the risk of additional generic competitors and channel loading later in the year.

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CEO William Lewis stated that reauthorization is a key part of payer negotiations aimed at a 'frictionless' process. COO Roger Adsett addressed the Medicare dynamics, noting Q4 is advantageous as patients have likely met their co-pay burden. He acknowledged the Q1 reset is a historical challenge but expressed hope that the process will be smoother in the second year of the new rules, with Insmed ready to provide patient support.

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CEO William Lewis noted the U.S. manufacturing plan has been underway for some time as part of a tariff mitigation strategy, with more updates to come. CMO Martina Flammer added that blinded data from the ENCORE trial looks consistent with the successful ARISE study, and in the BiRCh trial, key PROs are trending in the right direction.

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CEO William Lewis explained that the plan to establish a second U.S. manufacturing source for Brensocatib has been underway for some time, but did not provide a specific timeline. CMO Martina Flammer added that for the ENCORE trial, blinded PRO data trends look consistent with the successful ARISE study. For the BiRCh trial, both primary and secondary PROs are trending in the right direction.

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CMO Martina Flammer cited placebo rates from comparable studies ranging from 0.2 to 1.5 point reductions. CEO Will Lewis added that for both the CRS and TPIP Phase II studies, the goal is to see a clear directional signal, with statistical significance being less critical than informing a Phase III design. For TPIP, they noted the 6-minute walk is a key FDA endpoint but is highly variable, so they hope for a directional improvement over 20 meters.

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CEO Will Lewis confirmed a Q4 filing for brensocatib is on track, with an FDA decision on priority review expected in Q1 2025, which would dictate a mid-year launch. CFO Sara Bonstein noted launch timing would impact revenue models. CMO Martina Flammer clarified that for the ENCORE study, an additional 40-45 patients are in screening, with 15-20 expected to be randomized.

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CEO Will Lewis confirmed the brensocatib filing is on track for Q4, with a decision on priority review expected by day 74 post-filing, which would dictate a mid-year or late-year launch. CFO Sara Bonstein acknowledged that the timing of a launch within a quarter is an important factor for financial modeling. CMO Martina Flammer added that about 40-45 patients are still in the screening period for the ENCORE study, with an expected 15-20 to be randomized.

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CEO Jay Duker explained that while high-level masked demographics might be shared, the company will avoid releasing data that could introduce bias into the well-running trials. CMO Ramiro Ribeiro added that an independent data monitoring committee assesses safety. Regarding future updates, Duker confirmed it is 'quite likely' that periodic safety updates will be provided as the company hears from the Data Safety Monitoring Committee.

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President and CEO Dr. Jay Duker acknowledged that based on current trends, enrollment for the LUGANO trial could potentially complete in Q2 2025, though official guidance remains for the second half of 2025. Chief Medical Officer Dr. Ramiro Ribeiro added that for the DME indication, the company plans to propose a single, efficient Phase III study to the FDA with BCVA as the primary endpoint, with the meeting expected by summer.

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President and CEO Dr. Jay Duker confirmed a public update would follow receipt of written minutes from the agencies. He stressed that the wet AMD program is the absolute priority, and any decision on the DME program's timing is secondary to ensuring the success and financial runway for the wet AMD trials.

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Dr. Helen Sabzevari, President and CEO, expressed confidence in a 'fast fashion' for confirmatory trial enrollment, citing the rapid pace of prior trials and heightened patient interest following the ASCO data presentation. Phil Tennant, Chief Commercial Officer, confirmed the company has 'global ambition' for PRGN-2012, noting a significant disease burden and commercial opportunity exists ex-U.S., even in countries with HPV vaccine programs, due to the long lag time for population-level impact.

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