Guggenheim reiterated Top Pick
$EYPT Buy; $68
$OCUL REGN RHHBY SRZN KOD
$FDMT
Guggenheim said—Based our recent conversations with the buy-side, we get the sense that EYPT's key competitor OCUL has been cherry-picking and misrepresenting EYPT's Duravyu (TKI insert for aAMD/DME) safety data.
Here, we provide a detailed summary comparing the safety profiles of EYPT's Duravyu and OCUL's Axpaxli. In Exhibit 1, we list a total of 16 relevant adverse events (AEs) and the safety profile of Duravyu is highly favorable vs. that of Axpaxli. Notably, vitreous and anterior chamber opacities appear rather specific to Axpaxli, which has also shown a significantly higher rate of vitreous floaters. Importantly, there have been no cases of endophthalmitis associated with Duravyu; the three reported cases were related to Eylea injections.
We note that OCUL has misrepresented this in their handout by failing to disclose that these events were not related to Duravyu.
We further compiled data on vision loss (Exhibit 2), noting that significantly fewer patients experienced vision loss with Duravyu treatment compared to Axpaxli.
Hence, we continue to believe Duravyu's safety profile has been a key distinguishing feature, and its overall profile continues to look remarkably clean.
EYPT mgmt also reaffirmed the highly favorable safety profile of Duravyu in the ongoing Phase III LUGANO and LUCIA studies.
As of last week, 100% of LUGANO patients have received the 2nd injection (40% have received the third), and 80% of patients in LUCIA have received a 2nd injection.
Blinded safety data looks clean, with no safety events reported.
Finally, we believe EYPT's regulatory strategy is more robust, with two large non-inferiority studies versus SoC.
Given that multiple drugs are already approved for wAMD, we believe two Ph3 studies will be needed for approval. Hence, we expect EYPT to be first to market.
OCUL is currently trading at almost a 2x premium to EYPT (market cap of~$1.9Bn vs. EYPT at~$1.1Bn) and we expect this valuation gap to narrow. EYPT remains one of our Top Picks.