Avenue Therapeutics: Two-Step Merger with Cipla, CVR

Avenue Therapeutics (ATXI) is a one product development stage biotech with a binary investment outcome (let's be honest, most small biotechs are binary, this one just more explicitly so) related to their Stock Purchase and Merger Agreement with a subsidiary of Cipla, an India based global generic pharmaceutical company.  On 11/12/18 (closed in February), Cipla (via their U.S. subsidiary InvaGen) announced the purchase of 33.3% of Avenue for $35MM or $6/share (where it trades today) and agreed to purchase the remaining shares for $180MM or $13.94/share conditional on the FDA approval of IV Tramadol as a Schedule IV drug for post-surgery pain relief.

Tramadol is a fairly common pain reliever (~40th most prescribed medication in the U.S.), it has been around for decades internationally and was first approved in pill form in the U.S. in 1995.  Tramadol is an opiod, but it's considered a weak or a non-conventional opiod, most of the conventional opiods are classified as Schedule II controlled substances by the DEA, which essentially means they're highly susceptible to misuse and abuse, Tramadol contrastingly is Schedule IV (DEA's schedule is a I-V ranking, I being the most dangerous/no medical use).  Given the growing awareness of the opiod epidemic in this country, there's an opportunity for a painkiller that sits somewhere between Schedule II opiods like morphine or Vicodin and over-the-counter drugs like Tylenol and Advil.

Tramadol is currently only approved in oral/pill form in the U.S., Avenue (via their controlling shareholder Fortress Biotech - FBIO) owns the exclusive license to develop and commercialize an intravenous ("IV") version of Tramadol, IV Tramadol is widely approved and used (~10% of IV painkiller market share in Europe) internationally but hasn't been approved for use in the United States.  Avenue has already completed two Phase 3 studies of IV Tramadol with positive results, for moderate to moderately severe pain IV Tramadol has generally performed as well as morphine (don't need something as strong as morphine if you're only in moderate pain, something weaker does the job just as well).  Currently the company is putting together their new drug application ("NDA") to submit to the FDA for approval.

The conditions of the merger specify:

1. Final FDA approval of the Product on or before December 1, 2020, if as of such date there are no pending queries from the FDA with respect to such Product approval, but if there are such pending queries from the FDA as of such date, then such FDA approval shall have been obtained on or before April 30, 2021;
2. Labelling for the Product containing an indication as moderate to moderately severe (post-operative) pain, not restricted to any specific type of surgery; and
3. Classification of the Product by the U.S. Drug Enforcement Agency (“DEA”) as a Schedule IV Drug under applicable Legal Requirements; 

The timeline for FDA approval is typically about a year, 2 months of a preliminary review that justifies a full 10 month review of an NDA.  If Avenue is able (the company says they're on track) to complete and submit the NDA by the end of November, the 12/1/2020 deadline shouldn't be an issue.  By doing two Phase 3 studies (one for tummy tucks and one for bunion surgery) Avenue is going for the broad label and given IV Tramadol's widespread use, should have a good case for it.  The wildcard might be the Schedule IV classification, we are entering into an election season and opiod litigation is heavily in the news, if the DEA changes Tramadol to a Schedule II drug alongside the conventional opiods, that could blow a hole in the merger agreement.

If the merger is completed following FDA approval, Avenue shareholders will get an additional kicker in the form of a CVR tied to the sales of IV Tramadol with a $325MM annual revenue threshold with a favorable graduated tier scale above that.  One similar example to look at is IV acetaminophen (Tylenol), it is both a success story we can point to where it was approved in oral form for many years and then was only recently (well, 9 years ago) approved in IV form, but a quick Google and there's a lot of dispute whether the IV form is any different from than oral, especially hard to justify given that Mallinckrodt has done a series of price increases.  In 2017, IV acetaminophen did $300MM in sales, still below the CVR threshold for Tramadol many years after IV acetaminophen was commercialized.  But again, Tramadol might have a better chance of filling that pain gap than acetaminophen considering it's a weak opiod, either way, the CVR's value is likely many years off and not worth underwriting.

Avenue is an interesting binary outcome, the market is pricing in a less than 50% of chance of the merger with Cipla being completed, despite what appears to be a mostly straight forward FDA approval process (at least to this clueless retail investor) considering the drug is already approved in a different form in the U.S. and in the same form in many other developed markets.  Why is it mispriced?  Management answered this question by pointing to the lack of investor relations and promotion, they don't need additional financing after the deal with Cipla to complete the FDA approval process, so no need to promote the stock.  Makes some sense to me along with the relatively low float given the large stakes owned by FBIO and Cipla.  Additionally, I think people don't like such explicitly binary outcomes and general loss aversion keeps people away despite the seemingly favorable odds.  Thanks to "Ben's Jamin" who mentioned Avenue in a comment section a while back.

Disclosure: I own shares of ATXI