-Linzagolix for uterine fibroids: Received confirmation of positive CHMP opinion for marketing authorization application; United States NDA PDUFA date in Q3:22-
-Linzagolix for endometriosis: Reported positive topline results for linzagolix 200 mg with add-back therapy in the Phase 3 EDELWEISS 3 trial-
-Linzagolix franchise: Announced licensing agreement with Theramex to support commercialization in Europe, in addition to relationship with Syneos Health to support commercialization in the United States-
Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange
GENEVA, Switzerland – May 17, 2022 – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today reported financial results for the first quarter ended March 31, 2022 and provided a business update.
“We are eagerly anticipating the approval of linzagolix in Europe, which would mark our first product approval and a major achievement for ObsEva,” said Brian O’Callaghan, CEO of ObsEva. “With the potential to be, if approved, the first and only approved GnRH antagonist with flexible dosing options with and without hormonal add-back therapy, we believe linzagolix could transform the standard of care for millions of women living with uterine fibroids. In the United States, the regulatory review process likewise remains on track, setting ObsEva up for multiple potential approvals this year. We are advancing launch preparations in both markets through our commercial agreements with Theramex and Syneos Health to fully realize the significant commercial potential of linzagolix, while continuing to evaluate strategic opportunities in women’s health that could further enhance ObsEva’s value.”
Anticipated Milestones
ObsEva anticipates the following key clinical and regulatory objectives in 2022:
Pipeline Update
At the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting on May 6-8, additional data from the PRIMROSE Phase 3 studies of linzagolix for uterine fibroids was featured in an oral presentation and four posters. The analyses and post-treatment data continue to underscore linzagolix’s clinical utility and differentiated profile.
Leadership Transition
Financial Results for the First Quarter Ended March 31, 2022
The first quarter 2022 financial statements can be accessed in the financial reports section of the Company’s website, or directly here.
Webcast and Conference Call
ObsEva will host a conference call and webcast today at 8:00 a.m. Eastern time, 2:00 p.m. Central European Time. Individuals may participate via telephone by dialing (877) 300-8521 (domestic) or +1 (412) 317-6026 (international) and using conference ID 10166576. The webcast can be accessed live here and will also be accessible under “Events Calendar” in the investors section of ObsEva’s website. The webcast will be archived on the company’s website for at least 30 days after the conference call.
About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s health. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded 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 “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “might”, “ongoing”, “objective”, “plan”, “potential”, “predict”, “should”, “will”, “would”, or the negative of these and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential approval of linzagolix by regulatory authorities, including the European Commission and the FDA, and the timing of such approval and subsequent transition of ObsEva to a commercial-stage company, the timing or results of interactions with regulatory authorities, the commercialization of linzagolix across global markets, expected timing of the European Commission’s decision and the FDA target action date for linzagolix, clinical development of ObsEva’s product candidates, including the timing, advancement of, and potential therapeutic benefits of such product candidates, regulatory and development milestones, including the anticipated milestones and pipeline updates, the potential for such product candidates to be commercially competitive and the success of the Company’s partnerships with third parties. 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, including interactions with the European Medicines Agency during the marketing authorization application process and with the FDA during the NDA process for linzagolix, ObsEva’s reliance on third parties over which it may not always have full control, and the capabilities of such third parties, the impact of the ongoing novel coronavirus outbreak and other geopolitical events, 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, 2021 filed with the Securities and Exchange Commission (SEC) on March 10, 2022, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at 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, except as required by law, 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:
Katja Bührer
Katja.buhrer@obseva.com
+1 (917) 969-3438
Consolidated Statements of Comprehensive Loss
(in USD ’000, except per share data) | Three-month period ended March 31, | ||||||||
2022 | 2021 | ||||||||
Operating income other than revenue | 2,237 | 6 | |||||||
OPERATING EXPENSES | |||||||||
Research and development expenses | (5,608 | ) | (15,516 | ) | |||||
General and administrative expenses | (7,233 | ) | (4,191 | ) | |||||
Total operating expenses | (12,841 | ) | (19,707 | ) | |||||
OPERATING LOSS | (10,604 | ) | (19,701 | ) | |||||
Finance income | 1,933 | 629 | |||||||
Finance expense | (3,077 | ) | (911 | ) | |||||
NET LOSS BEFORE TAX | (11,748 | ) | (19,983 | ) | |||||
Income tax expense | (53 | ) | (21 | ) | |||||
NET LOSS FOR THE PERIOD | (11,801 | ) | (20,004 | ) | |||||
Net loss per share | |||||||||
Basic | (0.14 | ) | (0.29 | ) | |||||
Diluted | (0.14 | ) | (0.29 | ) | |||||
TOTAL OTHER COMPREHENSIVE INCOME / (LOSS) | — | — | |||||||
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD | (11,801 | ) | (20,004 | ) |
Consolidated Balance Sheets
(in USD ’000) | March 31, 2022 | December 31, 2021 | |||||||
ASSETS | |||||||||
Current assets | |||||||||
Cash and cash equivalents | 57,553 | 54,734 | |||||||
Other receivables | 953 | 3,560 | |||||||
Prepaid expenses | 5,756 | 5,223 | |||||||
Total current assets | 64,262 | 63,517 | |||||||
Non-current assets | |||||||||
Right-of-use assets | 521 | 625 | |||||||
Furniture, fixtures and equipment | 63 | 58 | |||||||
Intangible assets | 23,903 | 24,503 | |||||||
Other long-term assets | 395 | 288 | |||||||
Total non-current assets | 24,882 | 25,474 | |||||||
Total assets | 89,144 | 88,991 | |||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||||
Current liabilities | |||||||||
Other payables and current liabilities | 4,734 | 9,038 | |||||||
Accrued expenses | 15,421 | 13,783 | |||||||
Current lease liabilities | 624 | 686 | |||||||
Total current liabilities | 20,779 | 23,507 | |||||||
Non-current liabilities | |||||||||
Non-current lease liabilities | 119 | 240 | |||||||
Non-current borrowings | 33,134 | 25,733 | |||||||
Post-employment obligations | 6,563 | 6,581 | |||||||
Other long-term liabilities | 584 | 591 | |||||||
Total non-current liabilities | 40,400 | 33,145 | |||||||
Shareholders’ equity | |||||||||
Share capital | 6,812 | 6,489 | |||||||
Share premium | 436,694 | 430,630 | |||||||
Reserves | 33,236 | 32,195 | |||||||
Accumulated losses | (448,777 | ) | (436,975 | ) | |||||
Total shareholders’ equity | 27,965 | 32,339 | |||||||
Total liabilities and shareholders’ equity | 89,144 | 88,991 |
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