This is a PRE-REVENUE biotech stock, so feel free to stop reading.
Why am I writing about a pre-revenue biotech? Because:
- Strong (imo) likelihood that high-margin, recurring revenue is imminent.
- Strong (imo) likelihood they will trounce the competition and expand the relevant TAM
- Strong (…and almost 100% undetected by the market imo) potential for a wash/rinse/repeat model that can add new high-margin drugs at scale with minimal expense and (importantly, for a drug company) extremely limited TIME DELAY e.g. they potentially have a “platform” business model.
If you have a lung condition called PAH (Pulmonary Arterial Hypertension) you may need to inhale a generic drug called Treprostinil. Unfortunately the currently available mechanisms for doing so have MANY shortcomings; the main ones are:
- You have to breathe in hard, which you may have trouble doing with compromised lungs
- The dosing device (a “nebulizer”) does not effectively deliver the Treprostinil to the farther-flung/narrow parts of the lung
- …and the result is too much of the Treprostinil gets on some parts of the lungs (…resulting in toxicity), and not enough on others
- …and thus, patients are not able to get enough Treprostinil in them; the dosage is artificially limited by the dosing device.
$LQDA has technology (“PRINT”) that can produce arbitrarily shaped drug particles at a nano scale, and they used it to produce Treprostinil particles the size and shape of pollen.
((…I find this to be EXTREMELY ingenious; pollen has evolved to solve a problem that is almost identical to the problem described in 1…4, above. ))
With Treprostinil in this size/shape, it is MUCH easier to breath the Treprostinil in and it more efficiently/effectively gets to ALL the little tubes and passages in the lungs. As a result, MORE Treprostinil can be delivered safely with LESS toxicity. It’s a HUGE win for PAH patients, and there are dramatically successful PHASE 3 results to prove it.
But there’s a problem: a company called United Therapeutics ($UTHR), which has been using the Court system to delay market approval for $LQDA’s drug (“Yutrepia”). It’s done so based on patents having to do with the relevant device, and lawsuits alleging IP theft and corporate espionage, but MOSTLY based on patents that basically cover any/all methods of inhaling Treprostilil. These are (imo) seemingly indefensible patents based on “obviousness,” but $UTHR has been outrageously (…LITERALLY imo) successful in using the FDA and the Courts to keep Yutrepia away from patients who need it desperately.
This substack article: Waiting with Bated Breath for Liquidia Corp. has some good background on the legal battle, and there are several good articles on Seeking Alpha that go into gory detail on the legal battles and the tactics (…underhanded imo) $UTHR has engaged in.
Meanwhile, $LQDA submitted an application to additionally approve Yutrepia to treat another condition called PH-ILD, and of course $UTHR is also contesting that.
TL;DR : the risks
- (imo) Buying $LQDA now is essentially a bet that Mr. Market is underestimating the odds that $LQDA will prevail over $UTHR in court, get Yutripia to market and generate revenue.
- The (hopefully) last legal hurdle to FDA approval of Yutripia for PAH and PH-ILD has been cleared as of this past Friday may 31: $UTHR lost its appeal to the FDA’s decision to approve (see link below).
- $UTHR is a tenacious/ruthless litigator with a huge war chest and a lot of money to lose; they will continue to use the court system to battle $LQDA. They have even sued the FDA over the approval of Yutrepia!
TL;DR: the in-the-radar opportunity
- (imo) The most likely scenario is $UTHR and $LQDA sharing an extremely profitable duopoly for some number of years in a huge-and-growing TAM
- In fact, in some cases, patients are ABLE to use Yutrepia who are UNABLE to use $UTHR’s product. Thus, Yutrepia EXPANDS Treprostinil’s TAM.
- IMO this is the ALL the opportunity that Mr. Market is accounting for
TL;DR: the under-the-radar opportunity (…what REALLY gets me excited!)
- LQDA’s PRINT technology is potentially applicable to LOTS of drugs. Not just inhaled drugs; it’s potentially applicable, for instance, to drugs delivered into the bloodstream
- LQDA has stated in at least one past CC that they have significant “inbound interest” in licensing their PRINT technology
- PRINT technology, as demonstrated with Yutrepia, has the ability to DRAMATICALLY TRANSFORM the effectiveness of a generic drug.
- …Meaning there is HUGE blue sky potential to apply PRINT technology to ALREADY APPROVED generics that $LQDA can get CHEAP access to.
- Think about the decreased risk, the shorter timelines, the decreased study costs etc. vs. most drug companies. There essentially is zero risk in applying for an approval of an already-approved drug!
- …and the likely results in terms of profit margins, revenue expansion etc.
What if they find ONE more generic whose effectiveness will improve dramatically with PRINT technology? What if they find TEN?
I’m excited and have a medium (…for me) sized position.