Bay Street News

ObsEva Reports Third Quarter 2018 Financial Results and Provides Business Update


Geneva, Switzerland and Boston, MA – November 8, 2018 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today reported financial results for the quarter ended September 30, 2018, and provided a business update outlining recent corporate progress and upcoming milestones.

We continued to make significant progress this quarter with two positive data readouts; the live birth rate results from the IMPLANT 2 trial of nolasiban in IVF, and 24-week data from the Phase2b EDELWEISS trial of linzagolix in endometriosis,” said Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva. “With recent regulatory feedback on nolasiban, we plan to initiate IMPLANT 4 before year end and, assuming positive data, intend to file an MAA in late 2019. We are excited by the progress of this program and have begun preparation for commercialization in Europe.”


Recent Highlights


Upcoming Milestones

ObsEva expects to achieve the following clinical and regulatory milestones in 2018 and 2019:


Third Quarter 2018 Financial Results

Net loss for the third quarter of 2018 was $18.6 million, or ($0.42) per basic and diluted share, vs. $17.0 million or ($0.59) per basic and diluted share for the third quarter of 2017. Research and development expenses were $15.9 million and general and administrative expenses were $3.1 million for the quarter ended September 30, 2018, vs. $13.9 million and $3.0 million, respectively, for the quarter ended September 30, 2017.  Third quarter 2018 net loss included non-cash expenses of $2.0 million for share-based compensation, as compared to $2.3 million in the prior period.

As of September 30, 2018, ObsEva had cash and cash equivalents of $156.4 million.

To access the financial reports section of our website, please click here


Conference Call Information

ObsEva will host a conference call and audio webcast today at 8:00 a.m. Eastern Time, 2p.m Central European Time, to provide a business update and discuss third quarter 2018 financial results. To participate in the conference call, please dial 844-419-1772 (U.S.) or (213) 660-0921 (international) and refer to conference ID 3178666. The webcast can be accessed under the “Investors” section of ObsEva’s website www.obseva.com


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 woman’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 timing of enrollment in and data from clinical trials and the results of interactions with regulatory authorities. 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, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, 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, 2017, 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:

Media Contact Switzerland and Europe:
Christophe Lamps
Dynamics Group
cla@dynamicsgroup.ch
+41 22 308 6220 Office
+41 79 476 26 87 Mobile

Media Contact U.S.:
Marion Janic
RooneyPartners LLC
mjanic@rooneyco.com
+1 212 223 4017 Office
+1 646 537 5649 Mobile

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

Investor Contact:
Mario Corso
Senior Director, 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 September 30,
    Nine-Month Period
Ended September 30,
 
(in USD ’000, except per share data)   2018     2017     2018     2017  
    unaudited     unaudited  
Operating income other than revenue     2       3       10       11  
OPERATING EXPENSES                                
Research and development expenses     (15,909 )     (13,910 )     (46,945 )     (40,983 )
General and administrative expenses     (3,137 )     (3,001 )     (10,287 )     (9,601 )
Total operating expenses     (19,046 )     (16,911 )     (57,231 )     (50,584 )
OPERATING LOSS     (19,043 )     (16,908 )     (57,221 )     (50,573 )
Finance income     430       (106 )     616       754  
Finance expense           (1 )           (1 )
NET LOSS BEFORE TAX     (18,613 )     (17,015 )     (56,605 )     (49,820 )
Income tax expense     23       21       23       (36 )
NET LOSS FOR THE PERIOD     (18,590 )     (16,994 )     (56,582 )     (49,856 )
Net loss per share                                
Basic     (0.42 )     (0.59 )     (1.45 )     (1.78 )
Diluted     (0.42 )     (0.59 )     (1.45 )     (1.78 )
Weighted Average Number of Shares Outstanding     43,196,686       28,627,148       39,092,256       28,047,694  


Consolidated Balance Sheets


(in USD ’000)   September 30,
2018
    December 31,
2017
 
    unaudited     audited  
ASSETS                
Current assets                
Cash and cash equivalents     156,439       110,841  
Other receivables     695       783  
Prepaid expenses     1,670       1,490  
Total current assets     158,804       113,114  
Non-current assets                
Furniture, fixtures and equipment     292       323  
Intangible assets     21,608       21,608  
Other long-term assets     273       190  
Total non-current assets     22,173       22,121  
Total assets     180,977       135,235  
LIABILITIES AND SHAREHOLDERS’ EQUITY                
Current liabilities                
Current tax liability     17       51  
Other payables and current liabilities     1,474       2,865  
Accrued expenses     11,600       6,514  
Total current liabilities     13,091       9,430  
Non-current liabilities                
Post-employment obligations     3,004       3,099  
Other long-term liabilities     49       55  
Total non-current liabilities     3,053       3,154  
Shareholders’ equity                
Share capital     3,413       2,864  
Share premium     313,628       219,335  
Reserves     11,041       7,119  
Accumulated losses     (163,249 )     (106,667 )
Total shareholders’ equity     164,833       122,651  
Total liabilities and shareholders’ equity     180,977       135,235  

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