Myovant Stock: A Great Long-Term Play (NYSE:MYOV)

Myovant Sciences (NYSE:MYOV) is a great biotech to own for the long-term. The reason why I state this is because it has a PDUFA date of May 6, 2022 for a supplemental New Drug Application (sNDA) for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. In the United States MYFEMBREE is currently approved for the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment of up to 24 months. The FDA approval of this drug for this indication was achieved on May 26, 2021. Then, it has already been able to receive FDA approval of another drug in its pipeline known as ORGOVYX. This specific drug has been approved for the treatment of adults with advanced hormone-sensitive prostate cancer in December of 2020. A recent positive Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency was adopted for ORGOVYX in patients for adults with advanced hormone-sensitive prostate cancer. The European Commission should decide within the next two months and this could possibly be a huge catalyst for the biotech as well. It has a pretty solid pipeline and a few of these reasons above that I have listed are why I believe it is a great long-term biotech to own.

MYFEMBREE Drug Has Potential To Grow Depending Upon Added Approval

The thing is that Myovant Sciences has a major catalyst that is rapidly approaching. This involves the PDUFA action date of May 6, 2022 for the potential supplemental New Drug Application (sNDA) of MYFEMBREE for the treatment of moderate to severe pain associated with endometriosis. The reason for the sNDA submission for this indication is because of positive results reported from the phase 3 SPIRIT program. This involved two phase 3 studies known as SPIRIT 1 and SPIRIT 2. Each of these studies recruited women with pain associated with endometriosis and were treated over a 24-week period. In addition to these two late-stage studies, these women were also recruited into an open-label study as well. The data was good across all of these studies and this point was proven in this open-label study data as well. In the open-label study it was shown that women who took MYFEMBREE were able to have a meaningful reduction in menstrual pain of 84.8% at the 1-year mark. The reduction was actually even good when looking at non-menstrual pelvic pain at 1-year as well with a reduction of 73.3%.

Endometriosis is a painful issue in the tissue that normally lines the inside of your uterus which is known as the endometrium, grows outside of the uterus. The thing is that endometriosis most commonly involves several organs such as:

• Ovaries
• Fallopian tubes
• Tissue lining the pelvis

This is a large market opportunity as well, because the endometriosis sector across the seven major markets is expected to grow to $2.91 billion by 2030. As you can see, this is a large market opportunity. Supplemental FDA approval for MYFEMBREE for this indication would be huge. Hopefully, the sNDA of MYFEMBREE for moderate to severe pain associated with endometriosis is approved by the FDA.

The thing is that Myovant Sciences is already in great shape as it relates to MYFEMBREE. Why is that? That’s because this drug has already been approved by the FDA for the treatment of women with heavy menstrual bleeding associated with uterine fibroids in May of 2021. If the company can also obtain approval by the FDA for pain associated with endometriosis as well, then it will receive a $100 million regulatory milestone payment from its partner Pfizer (PFE). If it is approved, both companies expect to launch the drug commercially by May of 2022.

ORGOVYX Has Ability To Expand As Well

Myovant Sciences is firing on all cylinders, because it is still expanding the territories for which its drugs have been approved for. For instance, ORGOVYX has already received FDA approval for the treatment of adults with advanced prostate cancer in December of 2020. This FDA approval was made possible thanks to the phase 3 HERO study, which used ORGOVYX as a once-daily oral pill to treat men with advanced prostate cancer. The primary endpoint of the study was met in that 96.7% of men achieved sustained testosterone suppression to castrate levels < 50 ng/dL through 48 weeks of treatment. This compares to those who took leuprolide acetate injections.

Why was this FDA approval a substantial win for Myovant and how can it help the company going forward? Both of these questions can be answered with one simple answer and that is the ability for ORGOVYX to possibly become the new standard of care (SOC) therapy. That’s because leuprolide is currently the current SOC treatment option for men with advanced prostate cancer. Leuprolide is an injection that a patient receives, which is an androgen deprivation therapy (ADT) agent. Not only is this an injection option for patients but it is associated with a major problem in that there is a huge initial surge in testosterone levels that can make symptoms even worse. Even then, discontinuing the drug for whatever reason can cause recovery of testosterone in a delayed fashion. Why is this bad? An increase in testosterone can cause your cancer to get worse. The reason why I believe that ORGOVYX has a good shot at becoming standard of care of care (SOC) for men with advanced prostate cancer has to do with convenience. For leuprolide, a patient must go to the office/clinic to receive the injection. On the other hand, ORGOVYX can be taken orally at home.

As the subtitle eludes to above, Myovant Sciences has the potential to expand regulatory approval of ORGOVYX for advanced hormone-sensitive prostate cancer patients in Europe. This will include all 27 European territories including several others such as: Norway, Iceland and Liechtenstein. I believe that there is a good chance for European approval of ORGOVYX for these patients in the next few months. Why is that? Well, because the CHMP already gave its opinion recommending approval based on the phase 3 HERO study data I noted above in the beginning of this section. Obtaining regulatory approval of ORGOVYX is a huge catalyst indeed, but that is not all for this program. Around the very same time, Myovant hopes to release news about a possible partner for international rights to relugolix. If this happens, then it is another huge catalyst that would possibly cause the stock to trade higher.

Financials

According to the 10-Q SEC Filing, Myovant Sciences had cash, cash equivalents, marketable securities of $527.8 million as of December 31, 2021. It even has $41.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement it could use as well. The thing is that this company is seeing some pretty good growth across its approved drugs. It achieved Q3 2021 total revenues. This was thanks in part to U.S. sales of ORGOVYX of $24.4 million and $2.4 million in U.S. sales of MYFEMBREE. As I noted above, there is potential to expand approval for the use of MYFEMBREE with the supplemental New Drug Application (sNDA) for moderate to severe pain associated with endometriosis. The PDUFA date remains on track for May 6, 2022 and if all goes well, there should be a launch of the drug during the very same month. The FDA approval itself will also actually help Myovant’s cash position as well. That’s because if this regulatory approval of MYFEMBREE is achieved, then it would be eligible to receive up to $100 million milestone payment from Pfizer.

Risks To Business

The thing is that there are several risks that investors should be aware of when investing in Myovant Sciences. The first and biggest risk of them all would deal with the possible FDA approval of MYFEMBREE for moderate to severe pain associated with endometriosis, which is expected by May 6, 2022. There is no guarantee that the FDA will approve this drug for this indication. I believe that Myovant and Pfizer should receive FDA approval of this drug based on the numbers I noted above. MYFEMBREE was able to reduce menstrual pain by 84.8% and non-menstrual pelvic pain by 73.3% at the 1-year mark for these patients. Although, I would be cautious because one thing I have noticed is that even with good clinical data, the FDA sometimes tends to have issues with chemicals, controls and manufacturing (CMC) in the application. Even the smallest issue can sometimes pose a complete response letter (CRL). Regardless, I remain optimistic that it should receive FDA approval of MYFEMBREE for pain associated with endometriosis. A second risk would be similar in that there is no guarantee that the European Union will approve ORGOVYX for men with hormone-sensitive prostate cancer. I have confidence though that approval should likely be achieved for this as well. The only thing that is not clear is how well MYFEMBREE and ORGOVYX will sell this year. Sequential growth of ORGOVYX of 40% to $24.4 million compared to second fiscal quarter 2021 is nice to see. MYFEMBREE needs to grow more for the time being, but this remains to be seen.

Conclusion

The final conclusion is that Myovant Sciences is a great long-term biotech to own. The reason why I state this is because it has two approved drugs, which are MYFEMBREE and ORGOVYX. There is a supplemental New Drug Application (sNDA) of MYFEMBREE for the potential approval of pain associated with endometriosis. Then, it has the ongoing European review for potential approval of ORGOVYX for hormone-sensitive prostate cancer patients. With these potential regulatory approvals and some growth seen for its drugs from commercial launches, I believe it is a great long-term biotech to own. I think that this statement can be enhanced if Myovant can achieve what it states in its press releases in that both MYFEMBREE and ORGOVYX hold potential to become the new SOC agents in their respective indications. I truly think it’s possible, because they may be safer to take and are orally available. Whereas current SOC agents for these indications must be injected at a physician’s office and have other drawbacks. For instance, the drawback I mentioned above with respect to leuprolide treatment is where it causes an initial spike in testosterone. I think that Myovant Sciences is a great long-term biotech to own just based on MYFEMBREE and ORGOVYX. However, it even has another shot on goal with another drug known as MVT-602, which is to help with female infertility. More than 200 study patients have received treatment with MVT-602 in phase 1 and phase 2 clinical studies. This is another program that holds so much promise for Myovant in the future.