Press releases
May 5, 2020
GENEVA, Switzerland and BOSTON, MA (May 5, 2020) – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today reported financial results for the quarter ended March 31, 2020 and provided a business update.
“The first quarter of 2020 began very challenging times as we all faced the impact of the global COVID-19 pandemic”, said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva. “We acted very early on, taking appropriate operational and clinical trial measures to support the safety of patients in ObsEva’s trials, employees, and healthcare professionals. I am pleased that through our hard work and commitment, we remain on track to generate important Phase 3 clinical trial results later this quarter for linzagolix in the treatment of women with heavy menstrual bleeding (HMB) 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:
Second Quarter 2020 (June)
Second Half 2020
Fourth Quarter 2020/First Half 2021
First Quarter 2020 Financial Results
Net loss for the quarter ending March 31, 2020 was $21.9 million, or $0.48 per share, compared with a net loss of $25.7 million, or $0.59 per share, for the quarter ending March 31, 2019. Research and development expenses were $17.2 million and general and administrative expenses were $3.7 million for the quarter, compared with $20.1 million and $5.3 million, respectively, for the prior year quarter. The net loss for the quarter included non-cash expenses of $2.7 million for stock-based compensation, compared with $3.3 million a year ago.
The first quarter 2020 financial report 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 first quarter 2020 financial report 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 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 U.S., and 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
+41 22 552 1550
Investor Contact:
Mario Corso
Vice President, Investor Relations
+1 857 972 9347 Office
+1 781 366 5726 Mobile
Consolidated Statements of Comprehensive Loss
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Three-month period ended March 31, |
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(in USD ’000, except share and per share data) – unaudited |
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2020 |
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2019 |
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Operating income other than revenue |
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4 |
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5 |
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OPERATING EXPENSES |
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Research and development expenses |
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(17,188) |
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(20,140) |
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General and administrative expenses |
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(3,709) |
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(5,255) |
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Total operating expenses |
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(20,897) |
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(25,395) |
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OPERATING LOSS |
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(20,893) |
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(25,390) |
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Finance income |
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60 |
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262 |
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Finance expense |
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(1,011) |
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(544) |
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NET LOSS BEFORE TAX |
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(21,844) |
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(25,672) |
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Income tax expense |
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(19) |
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(7) |
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NET LOSS FOR THE PERIOD |
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(21,863) |
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(25,679) |
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Net loss per share |
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Basic |
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(0.48) |
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(0.59) |
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Diluted |
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(0.48) |
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(0.59) |
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Weighted Average Number of Shares Outstanding |
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45,725,561 |
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43,488,440 |
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Consolidated Balance Sheets
(in USD ’000) – unaudited |
March 31, |
December 31, |
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ASSETS |
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Current assets |
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Cash and cash equivalents |
62,042 |
69,370 |
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Other receivables |
514 |
1,044 |
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Prepaid expenses |
5,835 |
4,359 |
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Total current assets |
68,391 |
74,773 |
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Non-current assets |
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Right-of-use assets |
1,888 |
2,042 |
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Furniture, fixtures and equipment |
218 |
245 |
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Intangible assets |
26,608 |
26,608 |
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Other long-term assets |
276 |
275 |
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Total non-current assets |
28,990 |
29,170 |
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Total assets |
97,381 |
103,943 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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Current liabilities |
||||
Other payables and current liabilities |
12,023 |
8,432 |
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Accrued expenses |
11,141 |
10,418 |
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Current lease liabilities |
627 |
618 |
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Total current liabilities |
23,791 |
19,468 |
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Non-current liabilities |
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Non-current lease liabilities |
1,383 |
1,541 |
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Non-current borrowings |
25,012 |
24,917 |
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Post-employment obligations |
7,955 |
7,946 |
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Other long-term liabilities |
1,119 |
1,116 |
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Total non-current liabilities |
35,469 |
35,520 |
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Shareholders’ equity |
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Share capital |
3,699 |
3,499 |
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Share premium |
329,741 |
320,955 |
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Reserves |
23,955 |
21,912 |
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Accumulated losses |
(319,274) |
(297,411) |
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Total shareholders’ equity |
38,121 |
48,955 |
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Total liabilities and shareholders’ equity |
97,381 |
103,943 |
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