ObsEva (OBSV)

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FN Rating

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FN Summary: Lead asset (Yselty) for Uterine Fibroids P3 study achieved significant reduction in pain & MBL. It is also being tested for Endometriosis. There is significant competition from Myovant Sciences, which is in the exact same space, but ahead in drug development. OBSV also has Ebopiprant for preterm labor and will start a Phase 2b study in Q4 2021. OBSV will need to raise funds by the end of the year.

Table of Contents

This company hits a few of the right spots!

Experienced Management

Good Institutional Ownership

Outstanding Phase 3 Trials

Limited Competition

Plenty of Cash before next Catalyst

Large Market

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Next Catalyst

NDA Submission of Yselty ~ Q3 2021
Countdown Timer 👇
days until July 1
NDA Submission Announcement any day!
days until May 28

Interactive Chart

Cash on Hand

.

Est Monthly Cash Burn

$$$$

68M

7M

Notes

okay cushion...

just an estimate...burning through cash fast

Est Cash End of May 2021

54M

A secondary will occur by the end of the year.

Pipeline & Timeline

Products & Sales Potential

Product

Indication

Uterine Fibroids

Endometriosis

US Market

$2B

ROW Market

?

ObsEva Market Cap: ~ $245M as of May 25, 2021

Management

Yes, we get it. This is the boring part of the page. But, it is also the most important. Read this: Importance of Management
  • Brian O’Callaghan is a Life Science Executive with extensive experience within the biotech, big pharma and CRO sectors. He also has extensive global experience, having lived and worked in 5 different countries, as well as both sides of the US. He joined ObsEva in November 2020, as Chief Executive Officer to lead the Company through its future development, regulatory filings and product launches.
  • Prior to joining ObsEva, Brian has held CEO positions at Petra Pharma, Acucela, Sangart and BioPartners, as well as having held senior management positions at Pfizer, Merck Serono, Novartis, Covance and NPS Pharmaceuticals.
  • Brian has experience running both public and private companies, M&A’s, IPO’s, fundraising, divestments, spin-outs and strategic alliances. His operational experience is also wide ranging, having managed multiple businesses and programs, across many therapeutic areas, from concept through to commercialization. He also has extensive Board experience, having served on numerous biotech and 501c3 Boards.
  • Elizabeth Garner joined ObsEva in July 2019, bringing with her over a decade of pharmaceutical development experience, holding roles of increasing strategic responsibility in large and small companies, including Merck, Abbott (AbbVie), Myriad Genetics, and Agile Therapeutics, Inc.
  • From January 2014 to July 2019, Dr. Garner was Chief Medical Officer of Agile Therapeutics, Inc. and led the company’s clinical development, regulatory, and medical affairs strategies for Agile’s candidate transdermal contraceptive products. She was also instrumental in the company’s successful 2014 Initial Public Offering. Prior to her tenure at Agile, Dr. Garner was Vice President, Medical Affairs, Women’s Health/Preventive Care at Myriad Genetics, where she managed the Key Opinion Leader (KOL) programs, provided medical and scientific input on marketing strategies, and was the company’s media spokesperson. Before that, she was Senior Director at Abbott Laboratories, where she oversaw all clinical aspects of the global Phase 3 endometriosis development program for Orilissa® (elagolix, the first oral GnRH antagonist for treatment of endometriosis).
  • From 2007 to 2011, Dr. Garner was Associate Director and then Director, Clinical Research at Merck Research Laboratories. As a leader on the human papillomavirus (HPV) vaccine program she was instrumental in achieving successful outcomes on important regulatory submissions. Dr. Garner also served as chair of the Gardasil®9 HPV vaccine program Product Development Team. She was the core presenter for the 2010 FDA Gardasil® Advisory Committee Meeting for which she developed and delivered the company’s presentation that supported FDA’s approval of a gender-neutral anal cancer indication.
  • Jean-Pierre Gotteland joined ObsEva in September 2015 as Chief Scientific Officer and was also appointed Head of Research & Development in January 2018. He has over 20 years’ experience in the pharmaceutical industry in all product development stages, particularly in research, preclinical development and early clinical development.
  • After an early career at Pierre Fabre Medicament (France), he joined Serono in 1998 (subsequently Merck Serono) where he was responsible for various research and preclinical development programs in the areas of neurology, autoimmune disorders, endocrinology, metabolism and oncology. In 2007, he was one of the first employees to join PregLem, a Swiss based specialty biopharmaceutical company. As VP Non Clinical Development & CMC then Chief Development Officer, he actively contributed to the successful European registration of Esmya® (for the treatment of uterine fibroids), PregLem’s lead product, as well as to the progression of its development product portfolio.

Clinical Trials

Phase 3 trials concluded a while ago and the results are shown below.

Here is an overview of the PRIMROSE-1 (Phase 2b) & PRIMROSE-2 Clinical Trial. The results were outstanding.

Yselty met the primary endpoint for both doses. If approved this gives more options for doctors to prescribe the drug should the patient have an adverse event.

Company PDFs

(FN posts only the most recent documentation)

Read all of this 👇

Corp Presentation - May 2021

Analyst Price Targets

Ownership

Insider Ownership % (not precise)

Recent Insider Transactions

Could not find any info.

Institutional Holdings

Notable Institutional Ownership

Short Interest

Daily Short Volume Chart

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FAQ

Q. Will ObsEva partner with someone to market and sell Yselty
A. Yes.  According the Elle Investments management has made it an objective to enter into a partnership for Yselty commercialization.


Q. Is Yselty the only UF drug that offers a low dose without Add-Back-Therapy (ABT)?
A. Yes. This is one of OBSV’s dual label goals. Some women are not able to take hormone therapy for do not want to. This lower dose option is designed for that customer group.

Risks

The company is burning through cash at a rate of $7M per month. The next catalyst is the FDA submission of Yselty for UF sometime in the 3rd Q. NDA submissions can raise the SP, but usually not by much. FN expects a secondary to occur by the end of the year, which will depress the share price. FN does not see a significant catalyst before these funds are needed.

It is possible after the FDA submission that the FDA requests additional information related to safety. Recall that BMD did decrease slightly with Yselty, but not more than 3%. This will delay FDA approval (if given).

If Yselty gets FDA approval (and we expect it to) the drug will have an uphill battle to take over market share.

Email us at info@frugalnorwegian.com if you have more.  We want to list all risk factors for the drug & trial.

Competition

There is considerable competition in the UF and Endometriosis market. Yselty will be arriving 3rd into a crowded space.
AbbVie’s Orilissa is also an oral, once/twice-daily GnRH receptor antagonist for UF. It received FDA approval for endometriosis in July 2018 and launched in the US the following month.
Myovant Sciences produces Relugolix and has a partnership with Pfizer. Myovant is ahead of drug development and will beat Yselty to market. Relugolix will be serious competition for Yselty. More competition info here.

Have questions about this info? Did we miss a fact? We want to hear from you.

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