Seeking Alpha • Jul 05
ObsEva: Ignored, But Long-Term Prospects Exist On Recent Progress
Regulatory approval was achieved of Yselty for the treatment of women with uterine fibroids in the European Union.
Regulatory approval was achieved of Yselty for the treatment of women with uterine fibroids in the United Kingdom.
PDUFA date for potential FDA approval of Yselty for the treatment of women with uterine fibroids set for September 13, 2022.
Trial results from the phase 3 EDELWEISS 3 study and long-term extension study for endometriosis are expected 2nd half of 2022; Post-treatment follow-up results from extension study expected early 2023.
ObsEva SA (OBSV) is a great long-term biotech to own. The reason why I state that is because despite having received regulatory approval in two territories for linzagolix (marketed as Yselty) for the treatment of women with uterine fibroids, the stock still trades at a very low share price. It received approval of this drug for the treatment of this patient population for the European Union and for the United Kingdom.
I believe there is long-term potential just based on these approvals. However, there is an ability to further expand the reach of Yselty to the United States. That's because there is a PDUFA date set for September 13, 2022, and that is when the FDA will decide if this drug should be approved for the very same patient population for use in the United States. I believe that the FDA approval may carry more weight compared to the other two regulatory approvals.
Not only that, but the biotech won't have to attempt to sell the drug on its own. Instead, it has already been able to establish two partners for specific territories. It established a partnership for Theramex to sell the drug outside of the U.S., Canada, and Asia. The other partnership that was established was with Syneos Health to sell the drug within the United States upon regulatory approval. It is developing Yselty (linzagolix) for another large market indication which is endometriosis as well. With a few regulatory approvals for Yselty, plus another possible one on the way in Q3 of 2022, these are the reasons why I believe that ObsEva is a great long-term biotech to look into.
Two Regulatory Approvals With A Third One Being Possible
As I noted directly above, ObsEva received regulatory approvals of Yselty for the treatment of women with uterine fibroids in two territories. Uterine fibroids are benign tumors that end up forming in the uterus (womb) of a woman. When I state the term "benign," that means non-cancerous. The thing is that a majority of the time there are no symptoms. However, in certain cases, they can cause severe pain for the patient. There are several symptoms that uterine fibroids can cause, which are:
Heavy Menstrual bleeding
Prolonged periods
Pelvic pain
Cramping
Urge to urinate
One immediate item to point out is that Yselty was explored in uterine fibroid patients with heavy menstrual bleeding. Thus, heavy menstrual bleeding ((HMB)) is one of the symptoms involved with this disease. Some ways to treat this disease are surgeries and medications. Surgeries may involve attempting to go in and remove the uterine fibroids if successful. The other option involves medications. There are two types of medications:
SERMs (Selective estrogen receptor modulators) - work by changing estrogen levels in the body and holds the ability to shrink fibroids without causing menopause symptoms
GnRH agonist - GnRH is a type of hormone that a person's body makes naturally. These agonist drugs act as a counter to the production of the GnRH hormone. Thus, in turn it is able to shrink fibroids and sometimes can even reduce anemia as well
There are many other additional types of surgeries as well, like cutting off the blood supply to kill the fibroid off. The thing is that the uterine fibroids market is a large one. Well, it only treats women and it is just benign fibroids that are being formed in the uterus. Yes, but believe it or not it is indeed a major problem. Just in the United States alone, it is expected that the uterine fibroids treatment market is estimated to be worth $298.5 million by the end of 2027.
One of the first regulatory approvals was achieved back on June 22, 2022, from the European Commission ((EC)). This approval was followed by a positive opinion from the Committee Medicinal Products for Human Use of the European Medicines Agency back in April of 2022. Then, the biotech was able to receive UK Medicines and Healthcare Products Regulatory Agency ((MHRA)) approval of Yselty for this very same patient population.
The reason why Yselty was approved was because of positive results from the two phase 3 PRIMROSE studies that were done. It was noted from 24 weeks that there were huge response rates. The breakdown of such response rates is as follows:
A responder rate of 84.5% in women who received 200 mg linzagolix with hormonal add back therapy ((ABT))
A responder rate of 56.5% in women who received 100 mg of linzagolix without ABT
These two response rates, plus safety profile of the drug, is what allowed for these regulatory approvals. However, where I believe ObsEva may have a competitive advantage is that Yselty is the first drug approved for this specific patient population that gives women the option to be treated without the need for hormone therapy. The need for a drug like Yselty now is to help a woman either delay or avoid the need for surgery altogether.
There is potential to expand regulatory approval of Yselty to the United States with the upcoming FDA decision in the 2nd half of 2022. A Prescription Drug User Fee Act ((PDUFA)) date has been established with an action date of September 13, 2022. Agreement has been made in partnership with Theramex to sell Yselty outside of the U.S., Canada and Asia. Another agreement had been made with Syneos Health to sell the drug in the United States upon regulatory approval.
Financials
According to the 6-K SEC Filing, ObsEva had cash and cash equivalents of $57.6 million as of March 31, 2022. It has been able to raise cash through several different methods over the years. It raised about $5.7 million of net cash in Q1 of 2022 using its at-the-market offering program. Then, made $8.3 million in proceeds from its securities purchase agreement with JGB Management. Speaking of which, this JGB Securities Purchase Agreement is structured to provide about $135 million in borrowing capacity in nine tranches. The first and second tranche were achieved, October 2021 and then January 2022 respectively.