Boris Peaker

Boris Peaker asked for details on the initial patient adopters of ZUNVAIL, the current gross-to-net discount and its expected evolution, and the timing for the next $3 million milestone payment from CMS.

Answer

COO Lauren D'Angelo described the initial patient types as roughly half switching from donepezil and half being new to therapy, with a third category emerging around behavioral symptoms. CEO Michael McFadden stated the gross-to-net is currently around $600 and will likely settle in the $575 to $625 range in coming quarters. He also confirmed the next CMS payment is expected in the last quarter of 2025.

Inquired about the profile of initial patients adopting Zunveil, the current and future gross-to-net price, and the timing of the next milestone payment from CMS.

Answer

Initial patients are often switching from Donepezil or were previously untreated due to intolerance of other medications. The net price per prescription is currently around $600 and is expected to be in the $575-$625 range in coming quarters. The next $3M tranche from CMS is expected in Q4 of the current year.

Boris Peaker of Titan Partners asked about the status of FDA discussions regarding the DRAGON trial's interim data, its potential to trigger an NDA filing, and the data requirements from the DRAGON-2 study. He also inquired about plans for an interim analysis for the PHOENIX trial in geographic atrophy.

Answer

Chairman & CEO Tom Lin explained that the FDA recommended completing the 24-month DRAGON study for a potential single-study approval based on robust data, rather than pursuing an accelerated approval. He confirmed a single-study filing on DRAGON-1 is possible. He also stated that the PHOENIX trial will have an interim analysis around the halfway point, with the timeline yet to be finalized.

Boris Peaker from Titan Partners asked about the operational process for onboarding new hospitals, including committee approvals and integration steps. He also questioned the company's long-term strategy for mitigating tariff impacts, such as potentially moving manufacturing.

Answer

President Jonathan Harris explained the hospital onboarding process involves committee approvals, integration of Owlet Connect with the hospital's remote patient monitoring platform, and coordination with a DME partner for hardware supply. CFO Amanda Crawford addressed the tariff question, stating that Owlet is actively exploring manufacturing diversification to other locations, partly driven by the need for capacity expansion, to minimize future tariff impacts.

Inquired about the process for onboarding new hospitals and the company's strategy for mitigating tariff costs, including potentially moving manufacturing.

Answer

Onboarding a hospital involves a multi-step process of committee approval, technical integration of Owlet Connect, and coordination with a DME partner. To mitigate tariffs, the company is actively exploring alternative manufacturing locations, which aligns with their existing plans to expand capacity and diversify sourcing.

Boris Peaker from Titan Partners asked if the recent DSMB review for OCU400 in Retinitis Pigmentosa included a futility analysis or was purely for safety. He also requested the timing and expected content of the next interim update for OCU410 in Geographic Atrophy, the timeline for regulatory feedback from the EMA, and clarity on when the revenue from the Korean partnership would be recognized.

Answer

Chief Medical Officer Dr. Huma Qamar clarified that the DSMB review for OCU400 was purely for safety with no futility analysis. She and CEO Shankar Musunuri confirmed that an interim data update for the OCU410 ARMOR trial, including structural and functional outcomes at later time points, is planned for Q4. Mr. Musunuri added that feedback from the EMA on the Stargardt trial is expected by Q4 2025. Chief Accounting Officer Ramesh Ramachandran explained that the revenue from the Korean partnership will be recognized over a period extending into 2027, not at a single point in time.

Asked for the number of patients who went on to transplant and the dropout rate in the uproleselan study, and also inquired about the reason for the long duration of the NCI study.

Answer

The company stated that the transplant rate in the Phase III study is higher than the 31% seen in the Phase II trial, but did not disclose the exact number. The dropout rate was confirmed to be a very low 3%. Regarding the NCI study, the company speculates the delay is because the event trigger for the primary endpoint (EFS) has not been reached, which they view as a potentially positive sign for patients.