For a biotech to make money selling drugs, it doesn’t have to invent a blockbuster drug that will save the world. Another avenue to profit is to take old drugs that already work and then make them better. For instance, let’s say you have a drug in pill form, but you are giving it to small children who have trouble swallowing, so it would be better if the drug were a liquid. This is called reformulation and some companies specialize in doing just that.
Eton Pharmaceutics $ETON is a US company that specializes in making improvements of existing drugs, and they have an FDA approval decision date for one of those drugs on March 17, 2020.
Eton has a total of 8 drugs in its pipeline, one that’s already FDA approved, 3 that need FDA approval, and 5 others that they expect to get approved in 2020 / 2021.
The Drug With the Catalyst
The drug that is up for a FDA approval decision in March is called ET-105 and is a liquid formulation of one of the most widely used anti-epilepsy medications called lamotrigine. Lamotrigine is currently prescribed by doctors to patients who have seizures and bipolar disorder, but it is only FDA approved in tablet formulation. By making lamotrigine a liquid formulation, Eton hopes to be able to take a piece of the $700 million annual market for the drug.
History of the Company
Eton Pharmaceuticals is a Deer Park, IL company that was spun-out of Harrow Health $HROW in 2017 and IPOed in 2018 at $6/share and a $100 million market cap. The company was originally founded to commercialize two of Harrow Health’s drug candidates. Eton’s business model is to scout for drugs that that could be improved and then execute licensing deals, partnerships and joint ventures with the companies that own them.
Other Drugs In Pipeline
Eton’s first FDA approval was for Biorphen, a drug for anesthesiologists to use when patients experience low blood pressure. The product comes ready to inject.
After the company IPOed in 2018, it has had one FDA rejection and one FDA approval. Here is an annotated chart.
- FDA rejected the application for drug EM-100. Stock falls 15%
- FDA approves Biorphen. Stock initially goes up 17% but then gives up all gains.
Upcoming FDA Approval Catalyst
For many biotechs with potential blockbuster drugs, an FDA approval can be a binary event, sending the stock up 100%+ or down 50% on approval or rejection. Eton is not one of those stocks, and this catalyst is not a binary event. For the approval of Eton’s first drug, Biorphen, the stock barely moved, and we at Foreshadow expect a similar reaction on approval of ET-105. On a scale of 1 to 5, with 5 being the most explosive catalysts, we rate this catalyst a 1.
Currently Eton has no revenues, but that may change in the future with one drug already FDA approved and ET-105 coming up for approval.
Here is what the company says are the market sizes for its drugs.
The lamotrigine market alone is $700 million annually. Some back-of-the envelope math says that if they can capture 10% of the lamotrigine market, that would be $70 million in revenue a year. After yearly expenses of $40 million (what they spent in 2019), that is $30 million a year of profit. If you value the company like Harrow Health (NASDAQ: HROW), which trades with a price-to-earnings (P/E) of 10, that means Eton would trade at a $300 million market cap. Currently the stock is trading at a $100 million market cap.
Because of the sales potential, the company currently has 3 large-upside analyst price targets. Investment analysts from firms like B. Riley, Lake Street, and H. C. Wainwright all have buy ratings on the stock and one-year price targets between $13.50 – $23.00.
Although this FDA approval catalyst is unlikely to be a big mover event, if the company can accumulate drug approvals and start bringing in revenue, this certainly looks like an interesting opportunity for a longer-term investor.
- Stock: Eton Pharmaceuticals $ETON
- FDA Approval Date: March 17, 2020
- Catalyst Score: 1/5
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 24 hours. This article is for informational purposes only, and while the author makes every effort to present accurate and reliable information, Foreshadow, LLC does not guarantee the accuracy, completeness, efficiency, timeliness, or correct sequencing of such information. Reliance on such information should only be undertaken after an independent review of its accuracy, completeness, efficiency, and timeliness. This article is not intended to serve as a recommendation to buy or sell any security. The author is not a registered investment advisor.