Get ready, bargain shoppers. Foamix (FOMX) has plummeted 27% since the beginning of the year and it looks like the stock received more lashes than it deserved -- at least, according to Wall Street analysts.
2019 is poised to be a transformative year for Foamix. The company's acne treatment FMX101 is currently pending regulatory review in the U.S, and a PDUFA date of October 20, 2019 has been set. Furthermore, Foamix plans to submit a New Drug Application (NDA) for FMX103 during mid-2019, following positive long-term safety data in papulopustular rosacea patients.
Now, let's take a closer look at what analysts are expecting ahead of October's FDA decision.
FMX101's Approval Chances and Forecasts
Credit Suisse analyst Vamil Divan sees a high likelihood of regulatory approval for FMX101, applying a 90% probability of success (POS). The analyst rates FOMX stock an Outperform with a $9.00 price target, which implies nearly 250% upside from current levels. With an FDA approval in hand (100% POS), Divan says his price target will be boosted to $11.00. According to the analyst, "an increase in the sample size (1,507 patients in this trial vs. ~500 each in the two prior trials) and improved site selection and training helped drive statistically significant [clinical] results," which put the company on track to win FDA approval.
Similarly, H.C Wainright analyst Ram Selvaraju estimates the probability of regulatory approval at 85%, and assigns a $12.00 price target for the stock. If the price target is reached within 12 months, that would provide a 12-month return of nearly 360%. Selvaraju opined, "We believe that the current valuation situation presents an attractive entry point for value-focused investors, given the fact that Foamix currently trades about 2x book value [...] Our risk-adjusted net present value (rNPV) of FMX101 is $400M, which factors in an 85% probability of regulatory approval [...] We have employed a sum-of-the-parts valuation approach that yields a total projected firm value of $696M, which translates into a price objective of $12.00 assuming ~59M fully-diluted shares outstanding as of end-2019."
Selvaraju believes investors seem to be discounting both FMX101 and FMX103 from a commercial standpoint, but "this is unwarranted." Why? "These agents are based on well-known, validated and effective compounds in their respective target indications and have generated statistically significant efficacy data in large, robustlypowered pivotal studies. We also draw investors' attention to the large size and underserved nature of the target markets—namely, acne and rosacea—and the willingness of patients and physicians alike to try new formulations when they are introduced. Furthermore, we point to the user-friendly and well-tolerated nature of the Foamix formulations, which utilize the company's proprietary foam-based delivery technology to enhance efficacy while minimizing off-target systemic side effects," Selvaraju answers.
Cowen analyst Ken Cacciatore has recently spoken with 3 dermatology KOLs; they all agreed that "the clinical data were as good or better than they would have expected," and, according to the analyst, one has indicated that "it looked "more impressive" than Aczone (which peaked at over $200MM+ before genericization)." Cacciatore believes that given the wide use of oral minocycline, clinicians are eager to have this option with potential similar efficacy yet without the the systemic side effects, and therefore, the marketing of FMX-101 should be a very easy story to tell. The analyst says "FMX-101 should be able to easily surpass the peak prescription levels of Aczone (via our consultants' feedback)," and "this would place FMX-101 to achieve at least $250MM in revenue." Furthermore, the analyst believes FMX-101 could ultimately reach his target of $350MM given what he believes will be "improved efficacy/outcomes." Cacciatore argues that "even undifferentiated dermatology assets are selling at 3x peak revenue. Using just FMX-101 alone – and the low-end ($250MM) of what we believe will be the ultimate product size – would yield a value of $750MM, or $13-15 per share."
Foamix has seen its shares struggle mightily this year, but analysts continue to believe that this beaten-down biotech stock is a sure-fire winner. Analysts are confident that lead asset, FMX101, has substantial potential in treating acne, with an upcoming October 20, 2019 PDUFA date as a key potential positive catalyst for FOMX shares.
This latest pullback has arguably skewed the risk-to-reward ratio for the better -- perhaps making FOMX an attractive buy for risk-tolerant investors.