PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[midastouch017]

Milestones

https://finance.yahoo.com/news/plx-one-down-one-112600835.html

? PRX-115 to start Phase I – 1Q:23

? EMA approval for PRX-102 –May 5th, 2023

? FDA PDUFA date for PRX-102 – May 9th, 2023

? Investor event: Protalix Strategy – late June 2023

? PRX-115 Clinical Study Report – 1Q:24

Valuation

We update our valuation to reflect the May 5th, 2023 approval of PRX-102 by the European Commission (EC) and the increase in share count as a result of the ATM-related capital raise year to date. We had applied an 80% probability of EC approval and have now increased this to 100% following EC approval. We will adjust our probability of success for FDA approval when the status of PRX-102 is clear next week. We now have an 80% chance of success with the US regulatory body. We also shift our DCF valuation forward by one year. The net of our changes results in an increase in our target from $11 per share to $15 per share.

Summary

Protalix has received approval from one regulatory agency and should see a response from the other next week. Chiesi will take over the commercialization of PRX-102 following approval and the focus for Protalix will turn to the development assets are now moving towards center stage. The Phase I trial for PRX-115 has begun and the first 9 of an anticipated 56 subjects have been enrolled. Product sales were down year over year in 1Q:23; however, this is not a surprise as ordering and delivery for Pfizer and Fiocruz are volatile. License and R&D revenues were also down, reflecting this shift away from the development stage for PRX-102. While expectations for Elelyso are low, the product has been generally improving in its revenue contribution over the last several quarters and may benefit from additional sales in Europe following the expiration of exclusivity of Vpriv. EC approval supports a valuation increase. We update our valuation to $15.00 per share.