Opiant Pharmaceuticals Announces First Quarter 2022 Financial Results and Provides Corporate Update
SANTA MONICA, Calif., May 10, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today reported financial results for the three months ended March 31, 2022, and provided a corporate update. Recent highlights include:
Commenting, Roger Crystal, M.D., President and Chief Executive Officer of Opiant, said:
“The latest CDC data have put a spotlight on the continued worsening of the opioid crisis. The need for new safe and effective opioid overdose reversal treatments is greater than ever, and at Opiant we’ve made strong progress advancing the OPNT003, nasal nalmefene, development program. The compelling results of the recently completed PD study versus nasal naloxone add to the significant body of clinical and non-clinical evidence demonstrating the potential of our late-stage product candidate to offer an important treatment option for opioid overdose. With the planned clinical development program for OPNT003 now concluded, we have met with the FDA, and feel we are well-positioned to submit our NDA for OPNT003, which we anticipate occurring in the second half of this year. On the commercial front, preparations continue at pace. Beyond OPNT003, our robust pipeline also continues to progress, as patient enrollment and dosing ramp up in our ongoing Phase 2 study of OPNT002, nasal naltrexone, for alcohol use disorder.”
David O’Toole, Chief Financial Officer of Opiant, said:
“From a capital resource perspective, we ended the first quarter with approximately $51 million of cash and continue to prudently manage our expenses, enabling us to execute on our key commercial and R&D initiatives. We look forward to multiple potentially value enhancing regulatory, commercial and clinical catalysts in the quarters ahead.”
Financial Results for the First Quarter Ended March 31, 2022
The decrease in royalty rate was due to EBS applying the “Generic Reduction Clause,” which is provided for in the License Agreement between Opiant and Adapt Pharma. Since the generic entry of nasal naloxone into the U.S. marketplace in December of 2021, to the extent the clause is rightfully triggered, EBS can reduce royalties payable to Opiant to 2% for the quarter in the event U.S. net sales decrease by greater than 30% during the quarter when compared to the net NARCAN® sales in the quarter before the launch of the generic. The clause states that this calculation is completed separately each quarter, which means that the application of the Generic Reduction Clause this quarter has no bearing on whether it is triggered in the remaining quarters of 2022.
For the three months ended March 31, 2022, general and administrative (“G&A”) expenses were approximately $4.4 million, as compared to approximately $2.6 million in the comparable period in 2021. The $1.9 million increase was due to a $1.2 million increase in employee costs, including stock-based compensation and a $0.7 million increase in legal fees.
Research and development (“R&D”) expenses for the three months ended March 31, 2022, were approximately $8.8 million, as compared to approximately $4.1 million in the comparable period in 2021. The $4.7 million increase was primarily due to expenses associated with the completion of the clinical work for OPNT003. Approximately $2.2 million of the increase was offset by reimbursement by the contract with Biomedical Advanced Research and Development Authority (“BARDA”).
Sales and marketing (“S&M”) expenses for the three months ended March 31, 2022, were approximately $2.7 million for pre-commercialization efforts related to OPNT003.
Royalty expense for the three months ended March 31, 2022, was approximately $0.4 million and $1.0 million for the comparable period of 2021. The $0.6 million decrease was due to decreased royalty revenue from net sales of NARCAN® Nasal Spray.
Net loss for the three months ended March 31, 2022, was approximately $12.2 million, or a loss of $2.43 per basic and diluted share, compared to a net loss of approximately $2.8 million, or loss of $0.66 per basic and diluted share, for the comparable period of 2021.
As of March 31, 2022, Opiant had approximately $50.8 million in cash, cash equivalents, and marketable securities.
The OPNT003 development program has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800029C.
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