Opiant Pharmaceuticals Announces Second Quarter and First Half 2022 Financial Results and Provides Corporate Update
Opiant Pharmaceuticals (NASDAQ: OPNT) reported Q2 2022 revenues of $3.9 million, a decline from $11.3 million in Q2 2021, attributing $2.3 million to NARCAN® sales through Emergent BioSolutions (EBS). Opiant issued a default notice to EBS for underpayment of royalties, claiming $9.1 million is owed. R&D expenses surged to $7.9 million, up from $3.1 million year-over-year. The net loss for Q2 2022 was approximately $11.8 million, marking a substantial decline from a net income in Q2 2021. Opiant maintains a strong financial position with $40.2 million in cash as of June 30, 2022, and continues development of OPNT003 for opioid overdose.
- Completion of NDA for OPNT003 expected in H2 2022.
- Received $2.1 million funding from BARDA for OPNT003.
- U.S. Patent Office issued a Notice of Allowance for OPNT003 patent.
- Q2 2022 revenues declined to $3.9 million from $11.3 million in Q2 2021.
- Net loss of approximately $11.8 million in Q2 2022 compared to a net income in Q2 2021.
- Increased R&D expenses to $7.9 million from $3.1 million year-over-year.
SANTA MONICA, Calif., Aug. 11, 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 and six months ended June 30, 2022, and provided a corporate update. Recent highlights include:
Pipeline Update
- Rolling New Drug Application (NDA) submission for OPNT003, nasal nalmefene for opioid overdose remains on track, with completion expected in the second half of 2022
- Announced that the United States (U.S.) Patent and Trademark Office has issued a Notice of Allowance for U.S. patent with claims covering OPNT003 for opioid overdose
- Enrollment and dosing on track in 300-patient Phase 2 study for OPNT002, nasal naltrexone, for Alcohol Use Disorder (AUD); data expected in H1 2023
Finance Update
- Q2 revenues of
$3.9 million ;$2.3 million of revenue was attributable to the sales of NARCAN® Nasal Spray from Opiant’s License Agreement with Emergent BioSolutions, Inc. (EBS)
- EBS communicated that royalties from U.S. NARCAN® sales were calculated using a
2% rate, despite Q2 2022 U.S. net sales having been greater than70% of Q3 2021 thus requiring higher rates - Opiant delivered to EBS a default notice of material breach of its License Agreement for failure to pay the royalty rate set out in the License Agreement
- EBS communicated that royalties from U.S. NARCAN® sales were calculated using a
- Announced
$2.1 million funding awarded under its contract with the Biomedical Advanced Research and Development Authority (BARDA) for OPNT003 nasal nalmefene - Approximately
$40.2 million in cash and cash equivalents, as of June 30, 2022
Commenting, Roger Crystal, M.D., President and Chief Executive Officer of Opiant, said:
“At Opiant, we feel a strong sense of urgency to meet the need for new treatment options for opioid overdose, driven largely by fentanyl and other very potent illicit synthetic opioids, which are doing so much harm in our communities. We are on track to complete our NDA this year, and believe that OPNT003, nasal nalmefene, is particularly well suited to help confront this national overdose crisis. The value of OPNT003 was further validated by the allowance of our patent application by the USPTO. By year-end, we also anticipate completing enrollment in the Phase 2 study evaluating OPNT002 for the treatment of Alcohol Use Disorder, with data expected during the first half of next year. I am excited by the progress we have made and look forward to advancing our mission to deliver medicines to better treat addiction and drug overdose.”
David O’Toole, Chief Financial Officer of Opiant, said:
“Looking ahead, we are prudently managing expenses while maintaining our good financial position with multiple value creating catalysts expected over the next 12 months. With that said, we intend to pursue all avenues to ensure the terms of the NARCAN® licensing agreement are appropriately enforced.”
Financial Results for the Three Months Ended June 30, 2022
For the three months ended June 30, 2022, Opiant recorded approximately
For the three months ended June 30, 2022, general and administrative (G&A) expenses were approximately
Research and development (R&D) expenses for the three months ended June 30, 2022, increased by
Sales and marketing (S&M) expenses for the three months ended June 30, 2022, were approximately
Royalty expense for the three months ended June 30, 2022, was approximately
During the three months ended June 30, 2022, interest expense was
Net loss for the three months ended June 30, 2022, was approximately
On August 10, 2022, Opiant delivered a Default Notice to EBS under section 10.3 of its License Agreement. The Default Notice put EBS on notice it had materially breached one or more of its obligations under the License Agreement. Opiant stated cause for breach based upon the royalty report EBS provided Opiant for the quarter ended June 30, 2022. The EBS royalty report confirmed U.S. net NARCAN® sales during the second quarter were greater than
Financial Results for the Six Months Ended June 30, 2022
For the six months ended June 30, 2022, Opiant recorded approximately
For the six months ended June 30, 2022, G&A expenses were approximately
R&D expenses during the six months ended June 30, 2022, increased by
S&M expenses for the six months ended June 30, 2022, increased by
Royalty expense for the six months ended June 30, 2022, was approximately
Net loss for the six months ended June 30, 2022, was approximately
As of June 30, 2022, Opiant had
In August, Opiant announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded an additional approximately
Awards from BARDA for up to
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This project has been funded in whole or 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.
Conference Call Details: | |
Thursday, August 11th at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time | |
Toll Free: | 1-877-407-0792 |
International: | 1-201-689-8263 |
Conference ID: | 13730815 |
Webcast: | http://ir.opiant.com/ |
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose. For more information visit: www.opiant.com.
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements, and among other things, submit a New Drug Application in the second half of 2022. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "projects," "potential," or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2021, and our Form 10-Q for the quarter ended June 30, 2022, filed with the Securities and Exchange Commission on March 4, 2022, and August 11, 2022, respectively, including under the caption titled "Risk Factors." These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
Investor Relations Contacts:
Ben Atkins
VP of Corporate Communications and Investor Relations
Batkins@opiant.com
(310) 598-5410
Opiant Pharmaceuticals, Inc. | |||||||||
Condensed Consolidated Balance Sheets | |||||||||
(in thousands, except shares and per share amounts) | |||||||||
As of June 30 | As of December 31, | ||||||||
2022 | 2021 | ||||||||
Assets | (unaudited) | ||||||||
Current Assets | |||||||||
Cash & cash equivalents | $ | 40,173 | $ | 37,854 | |||||
Marketable securities | - | $ | 15,015 | ||||||
Accounts receivable | 2,336 | 13,327 | |||||||
Unbilled receivable | 1,637 | - | |||||||
Prepaid and other current assets | 3,612 | 2,963 | |||||||
Total Current Assets | 47,758 | 69,159 | |||||||
Other Assets | |||||||||
Property and equipment, net | 71 | 78 | |||||||
Right of use assets - operating leases | 733 | 1,000 | |||||||
Patents and patent applications, net | 11 | 12 | |||||||
Other non-current assets | 251 | 179 | |||||||
Total Assets | $ | 48,824 | $ | 70,428 | |||||
Liabilities and stockholders' equity | |||||||||
Current Liabilities | |||||||||
Accounts payable and accrued expenses | $ | 3,102 | $ | 3,370 | |||||
Accrued salaries & wages | 1,226 | 202 | |||||||
Royalty payable | 440 | 2,920 | |||||||
Deferred revenue | - | 17 | |||||||
Operating leases | 227 | 338 | |||||||
Total Current Liabilities | 4,995 | 6,847 | |||||||
Long-Term Liabilities | |||||||||
Operating leases - long term | 523 | 673 | |||||||
Convertible debt - net of unamortized discount | 13,710 | 16,069 | |||||||
Total Long-Term Liabilities | 14,233 | 16,742 | |||||||
Total Liabilities | 19,228 | 23,589 | |||||||
Stockholders' equity | |||||||||
Common stock, | |||||||||
authorized, 5,122,575 and 4,909,846 shares | |||||||||
issued and outstanding at June 30, 2022 and | |||||||||
December 31, 2021, respectively | 5 | 4 | |||||||
Additional paid-in-capital | 115,439 | 108,570 | |||||||
Accumulated other comprehensive loss | (243 | ) | (55 | ) | |||||
Accumulated deficit | (85,605 | ) | (61,680 | ) | |||||
Total stockholders' equity | 29,596 | 46,839 | |||||||
Total liabilities and stockholders' equity | $ | 48,824 | $ | 70,428 | |||||
Opiant Pharmaceuticals Inc. | |||||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||||
(in thousands, except shares and per share amounts) | |||||||||||||||||
Three months ended | Three months ended | Six months ended | Six months ended | ||||||||||||||
June 30 | June 30 | June 30 | June 30 | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||
Revenues | |||||||||||||||||
Royalty revenue | $ | 2,326 | $ | 9,314 | $ | 4,520 | $ | 13,648 | |||||||||
Grant and contract revenue | 1,568 | 1,945 | 3,845 | 3,998 | |||||||||||||
Total Revenue | 3,894 | 11,259 | 8,365 | 17,646 | |||||||||||||
Operating expenses | |||||||||||||||||
General and administrative | 4,011 | 2,733 | 8,343 | 5,380 | |||||||||||||
Research and development | 7,916 | 3,150 | 16,739 | 7,238 | |||||||||||||
Sales & marketing | 2,816 | 1,023 | 5,493 | 2,020 | |||||||||||||
Royalty expense | 517 | 2,107 | 943 | 3,086 | |||||||||||||
Total expenses | 15,260 | 9,013 | 31,518 | 17,724 | |||||||||||||
Income (loss) from operations | (11,366 | ) | 2,246 | (23,153 | ) | (78 | ) | ||||||||||
Other income (expense) | |||||||||||||||||
Interest income | 63 | 4 | 68 | 7 | |||||||||||||
Interest expense | (401 | ) | (542 | ) | (822 | ) | (1,079 | ) | |||||||||
Loss on foreign exchange | (24 | ) | 16 | (10 | ) | ||||||||||||
Total other income (expense) | (338 | ) | (562 | ) | (738 | ) | (1,082 | ) | |||||||||
Income (loss) before provision for income taxes | (11,704 | ) | 1,684 | (23,891 | ) | (1,160 | ) | ||||||||||
Income tax expense | (33 | ) | - | (33 | ) | - | |||||||||||
Net income (loss) | $ | (11,737 | ) | $ | 1,684 | $ | (23,924 | ) | $ | (1,160 | ) | ||||||
Other comprehensive income (loss): | |||||||||||||||||
Foreign currency translationadjustment | (161 | ) | (5 | ) | (188 | ) | 8 | ||||||||||
Comprehensive income (loss) | $ | (11,898 | ) | $ | 1,679 | $ | (24,112 | ) | $ | (1,152 | ) | ||||||
Net income (loss) per common share | |||||||||||||||||
Basic | $ | (2.31 | ) | $ | 0.39 | $ | (4.74 | ) | $ | (0.27 | ) | ||||||
Diluted | $ | (2.31 | ) | $ | 0.31 | $ | (4.74 | ) | $ | (0.27 | ) | ||||||
Weighted-average common shares outstanding: | |||||||||||||||||
Basic | 5,087,647 | 4,332,601 | 5,051,814 | 4,308,027 | |||||||||||||
Diluted | 5,087,647 | 5,427,831 | 5,051,814 | 4,308,027 | |||||||||||||
FAQ
What were Opiant's earnings results for Q2 2022?
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How much cash does Opiant have as of June 30, 2022?
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