Replies to post #241292 on Biotech Values

[dewophile]

MYOV

Orilissa actually has it in its PI that it should only be used with non-hormonal contraceptives, which may be a serious limitation in this population (if physicians adhere). Patients start on OCs not just because they help with pain but also because they need contraception.

The low dose of Orlissa may not be suppressive enough to be contraceptive - I haven't bothered to check the data bc to effectively control pain you need the higher dose which has the same 6 month limitation as lupron and hot flashes can really be limiting (not just a nuisance - can be disruptive to sleep etc).
I think getting contraception on label is a good idea, but I don't think it will be very limiting in the interim. A good rep should be able to convey when asked about contraception from a prescriber that the recommendation is to use backup contraception, but there is an ongoing trial designed to assess contraceptive efficacy, and oh here is our ovulation inhibition study. The convesation with a patient then becomes - ok continuous oral contraceptives are not controlling your pain, you just had a laparoscopy (or 5) already, you can go on lupron or Orlissa - you have to come off after 6 months unless we give add back but then i still woudl want you to get bone density checked periodically. oh and expect to get hot flahses it induces a medical menopause. Or there is a new drug that does not cause hot flashes because it has just enough estrogen along with the active medication to suppress both the hot flashes and maintain bone density - for which there is data up to 2 years out so you have at least 2 years if you want with this drug if it is working. The recommendation is to use backup contraception so either
1. let's put in an IUD (financially beneficial for the clinician)
2. Between you and me this agent has been shown to suppress ovulation totally and the company is running a trial to prove it is also an effective contraceptive, so on the record use condoms but off the record...
3. "Doc I don't care about contraception - I can't have intercourse anyway because of the pain (dyspareunia is common w endo), I can't get to work sometimes because of the pain - so anything to get this pain under control and not a problem I'll do whatever you suggest on the contraceptive front"

On the contraceptive story I could see some off label use for contraception in patients that cannot tolerate combined hormonal contraception. For example if OCPs trigger migraines, this would be a good alternative. Getting insurance to cover might be a challenge for some, but many will slip through- so many women have fibroids anyway (asymptomatic ) which can be coded, or enough menstrual cramps to code them as pelvic pain. The amount of estrogen in Myfembree is orders of magnitude lower than even low dose hormonal contraception (don't be confused with the units estradiol - which happens to be the most common estrogen produced naturally in the body - is much weaker than ethynil estradiol which is synthetic and used in pretty much all oral contraceptives (they differ in dose of estrogen and in the progestin components)). Another would be someone w some thrombophilia risk who is not a candidate for an IUD (hx STD, multiple sexual partners) or declines an IUD. This may be a harder sell because Myfembree has some estrogen, but the blood levels of estradiol on 1 mg are lower than endogenous estrogen levels produced without Myfembree so literally you are lowering the amount of estrogen and clotting risk vs taking nothing. (I check blood levels when giving estrace for fertility and I can tell you 1mg a day is equivalent to early follicular, 2mg bid - tid gets you E2 levels equivalent to around midcycle peak).
This is just added upside and not the core investment thesis IMO

Going after the experts / specialists may not be the most optimal strategy (although it's typically the most efficient at launch). Broader / larger investment may be needed to unlock the opportunity for these drugs, and it'll likely take longer.

By experts I assume you are thinking of reproductive endocrinologists who has been presenters and authors on alot of these papers. I am an RE. Or pelvic pain specialists but these are few and far between (even in NYC metro area it is hard to find a good pelvic pain specialist). The company is not planning to focus even initially on "experts" IMO. We are one of if not the largest REI groups and we have not seen a single rep for the fibroid indication, and I doubt we will get much traffic once the endo indication is approved (if they call we will turn them away probably). The reason is that infertilty and IVF is our bread and butter. The days of gyns referring pelvic pain (and difficult fibroid cases) to me - and most of my colleagues trust me - are in the past. Gyns now mange much of this themselves (drugs like Myfembree will be something they can give before a referral out), or for difficult cases have a colleague who does more minimally invasive surgery or has an interest in pelvic pain (not many of those around as I said).

Broader / larger investment may be needed to unlock the opportunity for these drugs, and it'll likely take longer.

longer is relative. I didn't follow Myov closely until fairly recently when a former co resident (who no longer practices clinically) asked my opinion as he was thinking of an investment. My deeper dive lead me to realize that there was a real disconnect between market expectations because of the Orlissa experience and what the true opportunity is, particularly in endo. I didn't build a position until now because I was far more bullish about the endo opportunity than fibroids, and I am not close at all to the prostate indication. With endo having a PDUFA in May I figured there was time and I didn't want to deal with the near term angst over the prostate launch and even fibroids. However the share price is now very compelling so I pulled the trigger. Unlike many biotech investors who worry about the next quarter (or the next day/week), I have a longer term horizon so I can give it a year for what I think may be real upside surprise when the drug is launched for endo later this year - and yes it may take 3-4 quarters. so is the middle of 2023 a long time? Not for me (and who knows there may be change in market sentiment earlier, soem buyout vig, and it is not often there is this nice opportunity with such a low bar set by a competitor drug - so I decided to start my position earlier than originally planned)