GENEVA, Switzerland and BOSTON, MA (August 6, 2020) – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a late clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today reported financial results for the quarter ended June 30, 2020 and provided a business update.

"The excellent phase 3 results from PRIMROSE 1 and PRIMROSE 2 last month were critical achievements as we now embark upon regulatory filings and commercial preparation”, said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva. “We strongly believe that our strategy to develop both a low dose of linzagolix without hormonal add back therapy and a high dose with hormonal add back therapy is the optimal way to treat more women suffering from heavy menstrual bleeding due to uterine fibroids.”

 

Pipeline Update

 

Linzagolix for the treatment of uterine fibroids and endometriosis

 

OBE022 to delay childbirth in pregnant women with preterm labor at 24-34 weeks of gestation

 

Nolasiban for improving pregnancy and live birth in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF)

 

Anticipated Milestones

ObsEva expects to achieve the following clinical and regulatory milestones in 2020-21:

 

Fourth Quarter 2020

 

First Half 2021

 

Second Quarter 2020 Financial Results

Net loss for the quarter ending June 30, 2020 was $18.2 million, or $0.38 per share, compared with a net loss of $34.8 million, or $0.80 per share, for the quarter ending June 30, 2019.  Research and development expenses were $15.4 million and general and administrative expenses were $2.2 million for the quarter, compared with $28.4 million and $6.2 million, respectively, for the prior year quarter.  The net loss for the quarter included non-cash expenses of $1.4 million for stock-based compensation, compared with $3.1 million a year ago.   

As of June 30, 2020, ObsEva had cash and cash equivalents of $45.0 million, compared with $69.4 million as of December 31, 2019.

The half-year report 2020 will be available in the financial reports section of the Company’s website.

To access the financial reports section of the Company’s website, please click [here].
To access the half-year report 2020 directly, please click [here].

 

About ObsEva

ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving IVF outcomes. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

 

Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates, the potential therapeutic benefits of such product candidates, the timing of enrollment in and data from clinical trials, including the impact of the COVID-19 pandemic on such trials, ObsEva’s plan to submit its MAA in Europe and NDA in the United States, YuYuan’s submission of an investigational new drug application in China, the results of interactions with regulatory authorities and ObsEva’s ability to enter into a future commercial partnership for linzagolix. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, the effects of the COVID-19 pandemic, any benefits from the joint collaboration with YuYuan or any future commercial partnership for linzagolix may not be fully realized or may take longer to realize than expected and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.ObsEva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

For further information, please contact:

 

CEO Office Contact:
Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550

Investor Contact:
Mario Corso
Vice President, Investor Relations
mario.corso@obseva.com
+1 857 972 9347 Office
+1 781 366 5726 Mobile

 

Consolidated Statements of Comprehensive Loss

   Three-Month Period
Ended June 30		  Six-Month Period
Ended June 30		 
(in USD ’000, except share and per share data) - unaudited 2020  2019  2020  2019 
Operating income other than revenue  4   1   8   6 
OPERATING EXPENSES                
Research and development expenses  (15,377)  (28,438)  (32,565)  (48,578)
General and administrative expenses  (2,191)  (6,186)  (5,900)  (11,441)
Total operating expenses  (17,568)  (34,624)  (38,465)  (60,019)
OPERATING LOSS  (17,564)  (34,623)  (38,457)  (60,013)
Finance income  48   (56)  108   206 
Finance expense  (690)  (43)  (1,701)  (587)
NET LOSS BEFORE TAX  (18,206)  (34,722)  (40,050)  (60,394)
Income tax benefit / (expense)  38   (34)  19   (41)
NET LOSS FOR THE PERIOD  (18,168)  (34,756)  (40,031)  (60,435)
Net loss per share                
Basic  (0.38)   (0.80)   (0.86)   (1.39)
Diluted  (0.38)   (0.80)   (0.86)   (1.39)
Weighted Average Number of Shares Outstanding  47,709,508   43,555,963   46,717,535   43,532,815 
                 
                 
                 

 

Consolidated Balance Sheets

(in USD ’000)  June 30,
2020		  December 31,
2019		 
ASSETS         
Current assets         
Cash and cash equivalents   44,965   69,370 
Other receivables   314   1,044 
Prepaid expenses   5,105   4,359 
Total current assets   50,384   74,773 
Non-current assets         
Right-of-use assets   1,734   2,042 
Furniture, fixtures and equipment   194   245 
Intangible assets   26,608   26,608 
Other long-term assets   278   275 
Total non-current assets   28,814   29,170 
Total assets   79,198   103,943 
LIABILITIES AND SHAREHOLDERS’ EQUITY         
Current liabilities         
Other payables and current liabilities   12,172   8,432 
Accrued expenses   7,171   10,418 
Current lease liabilities   642   618 
Total current liabilities   19,985   19,468 
Non-current liabilities         
Non-current lease liabilities   1,232   1,541 
Non-current borrowings   25,109   24,917 
Post-employment obligations   8,059   7,946 
Other long-term liabilities   1,133   1,116 
Total non-current liabilities   35,533   35,520 
Shareholders’ equity         
Share capital   3,781   3,499 
Share premium   332,566   320,955 
Reserves   24,775   21,912 
Accumulated losses   (337,442)  (297,411)
Total shareholders’ equity   23,680   48,955 
Total liabilities and shareholders’ equity   79,198   103,943 

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