Opiant Pharmaceuticals, Inc.

Second-quarter revenue was $3.9 million, including $2.3 million attributable to NARCAN sales under the EBS license. R&D expense was $7.9 million versus $3.1 million in Q2 2021; sales and marketing was about $2.8 million versus about $1.0 million; and G&A was about $4.0 million versus about $2.7 million. The company reported a net loss of $11.8 million, or $2.31 per basic and diluted share, versus net income of $1.7 million in Q2 2021. Cash and cash equivalents ended the quarter at $40.2 million, and BARDA provided an additional $2.1 million award, bringing total BARDA funding to $10.8 million. For guidance, management said the OPNT003 NDA is progressing as a rolling submission, with the non-clinical section submitted, CMC in final review/publishing, clinical section in progress, and completion targeted by year-end; if priority review is granted, a possible PDUFA date would be in Q2 2023. OPNT002 enrollment is expected to reach the target 300 patients by year-end, with data expected in the first half of 2023.

Roger Crystal focused on the clinical and commercial potential of OPNT003, saying the program is particularly well suited for fentanyl and other synthetic opioid overdoses because of its rapid onset, high receptor affinity, and longer duration. He described the first half of 2022 as an important period for advancing the company’s addiction and overdose pipeline, and said the coming months will be pivotal as the NDA submission is completed and launch preparations continue. On OPNT002, he said the company believes the nasal naltrexone approach could help reduce heavy drinking and is designing the study to limit placebo response.

David O’Toole said the quarter’s revenue shortfall was driven by NARCAN royalties, which were affected by EBS applying a 2% rate that Opiant считает inconsistent with the license terms. He said Opiant believes the correct Q2 payment should have been about $9.1 million, a difference of about $6.8 million, and noted the company issued a default notice on August 10 giving EBS 60 days to cure the breach. He also detailed increased spending in R&D, sales and marketing, and G&A, and said Opiant ended the quarter with $40.2 million in cash and cash equivalents while remaining “prudently” focused on expenses.

Analysts pressed on whether OPNT003’s rapid onset and long half-life could drive adoption, especially with generic NARCAN in the market, and whether governments might reassess overdose strategy if deaths do not improve. Management replied that both rapid onset and longer duration matter, emphasizing high receptor affinity for fentanyl and the risk of re-overdose with synthetic opioids. Questions also focused on patent protection, priority review timing, and the EBS royalty dispute; management said it has a strong case for priority review, expects the patent to be granted soon, and would not speculate on EBS’s motivations beyond saying the contract terms are clear.