Latest News by Industry
Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange
GENEVA, Switzerland – December 1, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN) (“ObsEva” or the “Company”), a biopharmaceutical company developing novel therapies for women’s health, today reported financial results for the third quarter ended September 30, 2022 and provided a business update.
“We are pleased to have neared the completion of a restructuring process that allowed us to generate an important influx of capital, positioned us to resolve our over-indebted position, and streamlined our cost structure,” said Brian O’Callaghan, CEO of ObsEva. “We are now well-positioned to support the development of nolasiban, a novel, oral oxytocin receptor antagonist being developed to improve clinical pregnancy and live birth rates in women undergoing in vitro fertilization, and we look forward to the initiation of our partner’s (Yuyuan BioScience) clinical trial following the recent approval of their IND in China.”
Recent Business Highlights:
Financial Results for the Third Quarter Ended September 30, 2022
The third quarter 2022 financial statements can be accessed in the financial reports section here of the Company’s website, or directly here.
About Nolasiban
Nolasiban is a novel, oral oxytocin receptor antagonist being developed to improve clinical pregnancy and live birth rates in women undergoing in vitro fertilization. ObsEva retains worldwide, exclusive, commercial rights for nolasiban, except for the People’s Republic of China where it has been sub-licensed to Yuyuan. Under the sublicense agreement with Yuyuan for nolasiban, ObsEva is entitled to receive aggregate milestone payments of up to $17 million upon the achievement of specified development, regulatory, and first sales milestones, and aggregate milestone payments of up to $115 million upon the achievement of additional, tiered sales milestones. In addition, Yuyuan has agreed to pay tiered royalties on net sales at percentages ranging from high-single digit to low-second digits.
About ObsEva
ObsEva is a biopharmaceutical company developing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a development program focused on improving clinical pregnancy and live birth rates in women undergoing in vitro fertilization. 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 statements regarding the status of ObsEva’s restructuring process, expected benefits from the sale of rights to ebopiprant to XOMA , ObsEva’s cash runway and indebtedness position, the ability of ObsEva to support the development of nolasiban, the receipt of potential milestone payments under the agreement with XOMA, the receipt of potential milestone and royalty payments under the sublicense agreement with YuYuan, Yuyuan’s plans to initiate a Phase 1 clinical trial for nolasiban as designed, expected savings from the workforce reduction, the timing, outcome and potential impact of ObsEva’s intended withdrawal of the pending moratorium proceedings before Swiss courts, and ObsEva’s plans for and ability to regain compliance with Nasdaq’s continued listing requirements. 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 in the ability of the proceeds from the sale of rights to ebopiprant to XOMA to provide the expected benefits, ObsEva’s cash requirements and ability to resolve its current indebtedness position, the achievement of milestones under the agreement with XOMA, the achievement of milestones under the sublicense agreement with YuYuan, the ability of Yuyuan to conduct a Phase 1 clinical trial for nolasiban as designed, the workforce reduction to provide the anticipated savings, the outcome and potential impact of ObsEva’s intended withdrawal of the pending moratorium proceedings before Swiss courts, including with respect to ObsEva’s agreements with third parties and outstanding debt obligations, ObsEva’s ability to successfully restructure its operations, ObsEva’s ability to regain compliance with the continued listing rules of Nasdaq and the potential for Nasdaq to use its discretionary authority to delist ObsEva’s common shares in connection with the pending Swiss moratorium proceedings if ObsEva is not able to withdraw such proceedings, 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, 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 Securities and Exchange Commission (the “SEC”) on March 10, 2022, in the Reports on Form 6-K filed with the SEC on May 17, 2022, August 17, 2022 and December 1, 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 Administrative Contact
Shauna Dillon
+41 22 552 1550
Investor Contact
Will Brown
+1 (334) 313-2319
Unaudited Condensed Consolidated Statements of Comprehensive Loss
| (in USD ’000, except per share data) | Three-month period ended September 30, | Nine-month period ended September 30, | |||||||||||||||
| Notes | 2022 | 2021 | 2022 | 2021 | |||||||||||||
| OPERATING INCOME OTHER THAN REVENUE | |||||||||||||||||
| Other operating income | 8 | 3 | 20,098 | 4,852 | 20,108 | ||||||||||||
| Assignment income | 8 | 3,709 | — | 3,709 | — | ||||||||||||
| Total operating income other than revenue | 3,712 | 20,098 | 8,561 | 20,108 | |||||||||||||
| OPERATING EXPENSES | |||||||||||||||||
| Research and development expenses | 9 | (692 | ) | (11,531 | ) | (13,411 | ) | (41,532 | ) | ||||||||
| General and administrative expenses | (3,649 | ) | (7,035 | ) | (18,393 | ) | (15,114 | ) | |||||||||
| Impairment of intangible asset | 5 | — | — | (19,400 | ) | — | |||||||||||
| Total operating expenses | (4,341 | ) | (18,566 | ) | (51,204 | ) | (56,646 | ) | |||||||||
| OPERATING (LOSS) INCOME | (629 | ) | 1,532 | (42,643 | ) | (36,538 | ) | ||||||||||
| Finance income | 2,885 | 128 | 2,385 | 702 | |||||||||||||
| Finance expense | (2,494 | ) | (822 | ) | (4,472 | ) | (2,423 | ) | |||||||||
| Loss on event of default | 6 | (17,586 | ) | — | (17,586 | ) | — | ||||||||||
| Gain on debt extinguishment | 6 | 5,713 | — | 5,713 | — | ||||||||||||
| NET (LOSS) INCOME BEFORE TAX | (12,111 | ) | 838 | (56,603 | ) | (38,259 | ) | ||||||||||
| Income tax income (expense) | 11 | 54 | (19 | ) | (53 | ) | (70 | ) | |||||||||
| NET (LOSS) INCOME FOR THE PERIOD | (12,057 | ) | 819 | (56,656 | ) | (38,329 | ) | ||||||||||
| Net (loss) income per share | |||||||||||||||||
| Basic and Diluted | 12 | (0.13 | ) | 0.01 | (0.65 | ) | (0.52 | ) | |||||||||
| OTHER COMPREHENSIVE INCOME | |||||||||||||||||
| Items that will not be reclassified to profit and loss | |||||||||||||||||
| Remeasurements on post-employment benefit plans, net of tax | 14 | 5,581 | — | 5,581 | — | ||||||||||||
| TOTAL OTHER COMPREHENSIVE INCOME | 5,581 | — | 5,581 | — | |||||||||||||
| TOTAL COMPREHENSIVE (LOSS) INCOME FOR THE PERIOD | (6,476 | ) | 819 | (51,075 | ) | (38,329 | ) | ||||||||||
Unaudited Condensed Consolidated Balance Sheets
| (In USD ’000) | Notes | September 30, 2022 | December 31, 2021 | ||||||
| ASSETS | |||||||||
| Current assets | |||||||||
| Cash and cash equivalents | 4 | 9,684 | 54,734 | ||||||
| Other receivables | 174 | 3,560 | |||||||
| Prepaid expenses | 1,705 | 5,223 | |||||||
| Total current assets | 11,563 | 63,517 | |||||||
| Non-current assets | |||||||||
| Right-of-use assets | 313 | 625 | |||||||
| Furniture, fixtures, and equipment | 45 | 58 | |||||||
| Intangible assets | 5 | 4,503 | 24,503 | ||||||
| Other long-term assets | 383 | 288 | |||||||
| Total non-current assets | 5,244 | 25,474 | |||||||
| Total assets | 16,807 | 88,991 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||
| Current liabilities | |||||||||
| Other payables and current liabilities | 7,213 | 9,038 | |||||||
| Accrued expenses | 10 | 2,353 | 13,783 | ||||||
| Current borrowings | 6 | 8,902 | — | ||||||
| Current lease liabilities | 367 | 686 | |||||||
| Total current liabilities | 18,835 | 23,507 | |||||||
| Non-current liabilities | |||||||||
| Non-current lease liabilities | — | 240 | |||||||
| Non-current borrowings | 6 | — | 25,733 | ||||||
| Post-employment obligations | 14 | 568 | 6,581 | ||||||
| Other long-term liabilities | 553 | 591 | |||||||
| Total non-current liabilities | 1,121 | 33,145 | |||||||
| Shareholders’ equity | |||||||||
| Share capital | 8,467 | 6,489 | |||||||
| Share premium | 441,306 | 430,630 | |||||||
| Reserves | 35,129 | 32,195 | |||||||
| Accumulated losses | (488,051 | ) | (436,975 | ) | |||||
| Total shareholders’ equity | 7 | (3,149 | ) | 32,339 | |||||
| Total liabilities and shareholders’ equity | 16,807 | 88,991 | |||||||
Attachment