June is shaping up to be a pivotal month for shareholders of Neos Therapeutics (NEOS) and Portola Pharmaceuticals (PTLA). Neos is gearing up for the potential launch of their second-ever product, while Portola is awaiting the early anticipated ruling from the FDA on its next-generation anticoagulant. For more on what these moves could mean for these companies, it's time for a deeper dive.
Neos Therapeutics is a small-cap pharmaceutical company developing modified-release drugs for the treatment of ADHD and other neurodevelopmental disorders. Currently, the company's only approved branded product is Adzenys XR-ODT, an orally dissolvable tablet (ODT) form of extended-release amphetamine indicated for treatment of attention deficit / hyperactivity disorder (ADHD).
Since its launch in May of 2016, sales of Adzenys have been growing well, with a total of 32,296 prescriptions filled between the months of January through March of this year. Monthly prescriptions increased 20% month-over-month during this timeframe, with total Adzenys revenue coming in at $3.1 million. As the company estimates that 54% of kids have difficulty swallowing tablets or capsules, and the total ADHD medication market to be worth $10.4 billion, these sales could have much more room to grow.
In order to capture more of this market, Neos is also developing an ODT version of methylphenidate, or as its better known branded version, Concerta. In December of last year, Neos submitted a new drug application (NDA) to the FDA for their ODT version of Concerta, labeled Cotempla XR-OTD. The company's PDUFA date is set for June 19th, 2017.
While Concerta has been generic for some time, Neos estimates that in 2016, methylphenidate generated $3.4 billion in sales in the U.S. alone. For a company with a market cap below $200 million, approval of Cotempla XR-ODT could have huge implications going forward.
While 2016 has been a great year so far for investors in Portola Pharmaceuticals, next month brings with it the potential to either give up much of those gains, or double-down on major profits.
The company's two lead products are betrixiban, a once-daily oral anticoagulant that is a factor Xa inhibitor indicated for the prevention of blood clots in acute medically ill patients, and andexanet alfa, the much famed "antidote" to the new generation of factor Xa anticoagulants.
In October of last year, Portola submitted a new drug application to the FDA for betrixiban as extended-duration prevention of blood clots in acute medically ill patients. In December, it was announced that the FDA accepted this NDA for priority review with a PDUFA date of June 24, 2017.
While "acute medically ill" may sound like a somewhat general term, this indication includes all patients hospitalized for serious non-surgical conditions such as heart attack, severe infection, stroke, or a host of rheumatic disorders. Due to these patients' immobility during hospitalization, they are generally at an increased risk of developing a blood clot. A long-lasting blood thinner is therefore recommended for use both during and in the weeks following hospitalization.
Although investors are arguably more excited for the potential approval of andexanet alfa, betrixiban is no slouch. While other factor Xa anticoagulants exist (Johnson & Johnson's Xarelto, and Bristol-Myer/Pfizer's Eliquis to name a few), none are approved specifically for extended-duration prevention of blood clots in acute medically ill patients.
The current standard of care for the prevention of blood clots in acute medically ill patients is Lovenox (enoxaparin), an injectable blood thinner marketed by Sanofi. While Lovenox has gone generic, total sales for the compound enoxaparin approximated $1.4 billion in 2015. As biotech companies usually trade for around 3 times potential sales, Portola, which has a market cap of around $2.4 billion could be undervalued on the potential of betrixiban alone.
The better investment today
It must be stated that Neos and Portola are two vastly different companies. Neos, at under a $200 million market cap is an order of magnitude smaller than Portola. In addition, while these are both biopharma companies, Neos only creates alternative delivery systems for existing therapies, while Portola is attempting to create new drugs altogether.
Overall, I'd say that Neos is the better risk-adjusted bet today. The company already has one drug approved and has been executing well on its marketing rollout. In addition, betrixiban's controversial data in its phase 3 trial leads me to believe the FDA may have further concerns involving this product before it receives the FDA's seal of approval. While both are great companies, I'd put my money on Neos.