For members who are still interested in Zevra (NASDAQ: ZVRA), here is the latest analyst rating.
CANTOR Fitzgerald
EQUITY RESEARCH January 2, 2024
Price: $6.55
Price Target: NA
Rating: Overweight
Large Cap Pharma, Biopharma, & Biotech
Zevra Therapeutics, Inc. (ZVRA)
Company Update
Don't Miss This One On The Way Up, Why We Like The Stock Heading Into 2024
We see three things this year that could drive ZVRA's stock to re-rate.
1. We expect the approval and launch of arimoclomol in 2H24 for the treatment of Niemann-Pick disease type C (NPC), an ultra-rare, genetic, progressive and fatal neurological disease.
ZVRA is prepared for an AdCom, but it is not certain one will be required. See more details on arimoclomol's resubmission here.
The advocacy community plans to send a petition to the FDA in support of arimoclomol's approval. See details here.
If approved, ZVRA expects a bolus of patients, ~70, in its early access program to be converted into commercial patients.
2. ZVRA could report better than expected sales for OLPRUVA, which is indicated for the treatment of urea cycle disorders (UCDs).
This product comes from the acquisition of Acer. ZVRA will finish creating a commercial infrastructure, in January, for a previously un-promoted drug which should accelerate sales, in our view. See more details here.
The integration of Acer is important for arimoclomol because there is an 80-90% overlap between UCD and NPC. ZVRA is also deciding whether or not to move forward with other products in Acer's pipeline, some of which have not been disclosed yet.
3. We expect ZVRA to report positive topline data from its Phase 2 Idiopathic Hypersomnia (IH) study for KP1077. The Street is underestimating the market opportunity for KP1077, in our view. Notably, KP1077:
Should receive better scheduling than other stimulants, making it more accessible; physicians we have spoken with think that this is a meaningful competitive advantage for the drug
Its smooth PK profile should result in fewer CV events allowing higher doses to be given, hence increasing efficacy without compromising safety
There is a large unmet need for the treatment of IH which opens a meaningful market opportunity for KP1077, if the data are positive.
ZVRA is also looking at KP1077 for the established indication of narcolepsy as well.
There is no financing overhang. When ZVRA reported 3023 results it noted that as of 9/30/23 it had $83.4MM in cash, cash equivalents, and investments which supports a cash runway into 2026. Notably, the cash runway forecast does not include commercial revenue from arimoclomol following potential FDA approval 2H24, or the potential sale of the Priority Review Voucher (PRV), which could be received upon approval (could be worth ~$100MM), or any revenue from sales of OLPRUVA.