ObsEva S.A.

ObsEva ended Q1 2022 with approximately $58 million of cash, up from $55 million at the end of 2021. The company said the increase in net cash came from over $20 million of gross receipts, including $5.7 million of gross ATM receipts, $8.3 million from the JGB convertible debt agreement, and a $5.7 million upfront payment from the Theramex licensing agreement, offset by operating and investing cash use. Revenue was $2.2 million in Q1 2022 versus $6,000 in Q1 2021, reflecting partial recognition of the Theramex upfront payment; the remaining EUR2.5 million is expected to be recognized once European marketing authorization is granted. R&D expense was $5.6 million versus $15.5 million a year ago, G&A was $7.2 million versus $4.2 million, and net loss was $11.8 million, or $0.14 per share, versus $20 million, or $0.29 per share. Forward-looking commentary focused on potential approvals for linzagolix in Europe and the U.S. within the next six months, the U.S. PDUFA date of September 13, 2022, and discussion of next steps with regulators for endometriosis.

Brian O’Callaghan framed 2022 as a pivotal transition year from late-stage development to a commercial company. His strategy centered on linzagolix as a differentiated product for uterine fibroids because it offers flexibility for women who can take hormonal add-back therapy and for those who cannot, are at risk of, or do not want it. He also positioned the broader company as active in partnerships and strategic opportunities, saying current market conditions could support roll-ups, M&A, licensing, or other deals that enhance value.

Will Brown focused on liquidity, financing, and the quarter’s cost structure. He said cash on hand was approximately $58 million at quarter-end, supported by more than $20 million of gross receipts, including ATM proceeds, convertible debt proceeds, and the Theramex upfront payment. He also explained that revenue of $2.2 million was driven by partial recognition of the Theramex payment, R&D fell to $5.6 million as PRIMROSE costs wound down, G&A rose to $7.2 million on commercial launch expenses, and net loss narrowed to $11.8 million, or $0.14 per share.

Analysts focused on timing for endometriosis regulatory discussions, the likelihood of an FDA advisory committee, and launch dynamics for uterine fibroids. Management said it will be in communication with the FDA on endometriosis before year-end and had heard nothing to suggest an ADCOM is expected. On uterine fibroids, Clive Bertram said the current oral GnRH antagonist market is still early, but the class is expanding overall and linzagolix’s no-add-back option could address a large portion of patients not served by current products.