Last Updated on March 15, 2022 by GlobeNewsWire
SANTA MONICA, Calif., March 15, 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 and twelve months ended December 31, 2021, and provided a corporate update. Recent highlights include:
Q4 revenues of $13.8 million, an increase of 39% compared to the same period in 2020 Exceeded full-year 2021 royalty revenue guidance of approximately $38 million with 2021 royalty revenue of approximately $41 million, a 49% increase over full-year 2020 Full-year net income of $3.0 millionWell capitalized, with approximately $53.0 million in cash, cash equivalents and marketable securities, as of December 31, 2021
OPNT003, nasal nalmefene, for opioid overdose: Reported positive topline results from pharmacokinetic (“PK”), safety and tolerability multidose studyCompleted enrollment in pharmacodynamic (“PD”) study comparing nasal nalmefene and nasal naloxone, with top line data now expected in Q2 2022Pre-NDA Meeting with the FDA scheduled for late March 2022Targeting New Drug Application (“NDA”) submission mid-year 2022; commercial preparations well underway for a potential commercial launch in 2023OPNT002, nasal naltrexone, for Alcohol Use Disorder (“AUD”): Initiated patient dosing in Phase 2 study, with data expected in H1 2023
Commenting, Roger Crystal, M.D., President and Chief Executive Officer of Opiant, said:
“Opiant delivered strong financial results in 2021, and continued pipeline momentum, led by OPNT003, nasal nalmefene. We believe the compelling results generated to date from our ongoing development program support OPNT003’s potential to be a differentiated treatment option for the emergency treatment of opioid overdose, particularly in the community setting. In parallel, we initiated dosing in our Phase 2 study for Alcohol Use Disorder, an important advancement for our deep pipeline aimed at bringing about a paradigm shift in the treatment of addictions and drug overdose. Looking ahead, with the clinical portion of our work complete, we look forward to the upcoming top line data from the PD study and remain dedicated to progressing OPNT003 to NDA submission, as well as the continued growth of our commercial organization in preparation for a potential launch in the U.S.”
David O’Toole, Chief Financial Officer of Opiant, said:
“We ended the year with approximately $53 million of cash and continue to prudently manage our capital resources, providing us with a strong financial foundation to support our commercial and R&D initiatives. Based on our anticipated upcoming catalysts and product pipeline, we believe we are well-positioned to drive increasing value for all key stakeholders.”
Financial Results for the Fourth Quarter Ended December 31, 2021
For the three months ended December 31, 2021, Opiant recorded approximately $13.8 million in revenue, compared to approximately $10.0 million during the corresponding period of 2020. $13.0 million of revenue was attributable to the license agreement with Emergent BioSolutions, Inc. (“EBS”) for the sale of NARCAN(R) Nasal Spray, compared to approximately $8.3 million in the same period of 2020, and approximately $0.8 million came from grant and contract revenue, compared to approximately $1.6 million in the same period in 2020. Fourth quarter 2021 sales of NARCAN(R) Nasal Spray were approximately $120.6 million, as reported by EBS.
For the three months ended December 31, 2021, general and administrative (“G&A”) expenses were approximately $3.4 million, as compared to approximately $3.6 million in the comparable period in 2020.
Research and development (“R&D”) expenses for the three months ended December 31, 2021, were approximately $4.7 million, as compared to approximately $4.5 million in the comparable period in 2020.
Sales and marketing (“S&M”) expenses for the three months ended December 31, 2021, were approximately $1.5 million for pre-commercialization efforts related to OPNT003. Sales and marketing expense during the three months ended December 31, 2020, were approximately $0.9 million.
Royalty expense for the three months ended December 31, 2021, was approximately $2.9 million and $1.9 million for the comparable period of 2020. The $1.0 million increase was due to increased royalty revenue from net sales of NARCAN(R) Nasal Spray.
Net income for the three months ended December 31, 2021, was approximately $0.8 million, or income of $0.17 per basic share and $0.11 per diluted share, compared to a net loss of approximately $0.7 million, or loss of $0.16 per basic and diluted share, for the comparable period of 2020.
Financial Results for the 12 Months Ended December 31, 2021
For the twelve months ended December 31, 2021, Opiant recorded approximately $47.8 million in revenue, compared to approximately $29.6 million during the corresponding period of 2020. For the twelve months ended December 31, 2021, the Company recorded approximately $40.7 million of revenue from the sale of NARCAN(R) Nasal Spray, compared to approximately $27.4 million in the same period of 2020. Sales of NARCAN(R) Nasal Spray for the twelve months ended December 31, 2021, were approximately $434.3 million, as reported by EBS.
For the twelve months ended December 31, 2021, the Company recorded approximately $7.1 million in grant and contract revenue compared to approximately $2.2 million in the same period in 2020. The $4.9 million increase in grant and contract revenue was due to the increased funding received from the National Institute of Drug Abuse and Biomedical Advanced Research and Development Authority for the development of OPNT003.
For the twelve months ended December 31, 2021, G&A expenses were approximately $12.2 million, compared to approximately $11.7 million in the comparable period in 2020.
R&D expenses for the twelve months ended December 31, 2021, were approximately $16.8 million, as compared to approximately $9.2 million in the comparable period in 2020. R&D expense increased by $7.6 million primarily due to increased activity on OPNT003.
S&M expenses for the twelve months ended December 31, 2021, were approximately $4.6 million compared to approximately $4.7 million in the comparable period in 2020.
Royalty expense for the twelve months ended December 31, 2021, was approximately $9.1 million, compared to approximately $6.2 million for the comparable period of 2020. The $2.9 million increase was due to increased royalty revenue from net sales of NARCAN(R) Nasal Spray.
Net income for the twelve months ended December 31, 2021, was approximately $3.0 million, or income of $0.68 per basic share and income of $0.51 per diluted share, compared to net loss of approximately $1.9 million, or a loss of $0.44 per basic and diluted share, for the comparable period of 2020.
As of December 31, 2021, Opiant had approximately $53.0 million in cash, cash equivalents, and marketable securities.
We are not providing royalty revenue guidance, currently, due to the uncertainty of the level of sales of NARCAN(R) Nasal Spray in 2022. We intend to provide guidance later in 2022, once we determine the potential impact of the launch in December of 2021 of a generic equivalent by Teva Pharmaceuticals.
The OPNT003 development project 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.
Conference Call Details:Tuesday, March 15th at 4:30 p.m. Eastern Time/1:30 p.m. Pacific TimeToll Free:1-877-407-0792International:1-201-689-8263Conference ID:13726931Webcast:http://ir.opiant.com/
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc., the company that developed NARCAN(R) Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.
For more information visit: www.opiant.com.
This press release contains forward-looking statements, including anticipated results and timing of the receipt of data from our PD study and timing of filing of an NDA. 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 or our industry’s 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, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. 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 same 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 filed quarterly reports on Form 10-Q and our annual report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission on March 15, 2022, 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:
VP of Corporate Communications and Investor Relations
Opiant Pharmaceuticals Inc. Consolidated Statements of Operations and Comprehensive Income (Loss) (in thousands, except shares and per share amounts) Year ended Year ended Three months ended Three months ended December 31, December 31, December 31, December 31, 2021 2020 2021 2020 (Unaudited) (Unaudited) Revenues Royalty revenue $40,725 $27,402 $13,036 $8,345 Grant and contract revenue 7,060 2,223 764 1,579 Total revenue 47,785 29,625 13,800 9,924 Operating expenses General and administrative 12,153 11,742 3,394 3,604 Research and development 16,834 9,240 4,715 4,477 Sales & marketing 4,576 4,687 1,496 949 Royalty expense 9,066 6,197 2,921 1,908 Total expenses 42,629 31,866 12,526 10,938 Operating income (loss) 5,156 (2,241) 1,274 (1,014) Other income (expense) Interest income, net 11 94 1 2 Interest expense (2,129) (131) (503) (131) Gain (loss) on foreign exchange (5) (9) 4 (7) Total other income (2,123) (46) (498) (136) Net income (loss) before income taxes 3,033 (2,287) 776 (1,150) Income tax benefit (expense) (24) 426 27 465 Net income (loss) $3,009 $(1,861) $803 $(685) Other comprehensive income (loss) Foreign currency translation adjustment (28) (27) (27) 88 Total other comprehensive income (loss) $2,981 $(1,888) $776 $(597) Net income (loss) per common share Basic $0.68 $(0.44) $0.17 $(0.16) Diluted $0.51 $(0.44) $0.11 $(0.16) Weighted-average common shares outstanding: Basic 4,456,162 4,249,832 4,742,530 4,258,105 Diluted 5,920,069 4,249,832 7,111,376 4,258,105 Opiant Pharmaceuticals, Inc. Consolidated Balance Sheets (in thousands, except shares and per share amounts) As of December 31, As of December 31, 2021 2020 Assets Current Assets Cash & cash equivalents $37,854 $48,251 Marketable securities 15,015 – Accounts receivable 13,327 8,911 Prepaid expenses and other current assets 2,963 1,937 Total Current Assets 69,159 59,099 Long-term Assets Property and equipment, net 78 171 Right of use assets – operating leases 1,000 279 Patents and patent applications, net 12 13 Other non-current assets 179 1,051 Total Assets $70,428 $60,613 Liabilities and stockholders’ equity Current Liabilities Accounts payable and accrued liabilities $3,370 $2,966 Accrued salaries and wages 201 909 Royalty payable 2,920 1,908 Deferred revenue 17 355 Operating leases – current 338 282 Total Current Liabilities 6,846 6,420 Long-Term Liabilities Operating leases – long term 673 – Convertible debt, net of issuance costs 16,069 18,701 Total Long-Term Liabilities 16,742 18,701 Total Liabilities 23,588 25,121 Stockholders’ equity Common stock, $0.001 par value, 200,000,000 shares authorized, 4,909,846 and 4,258,105 shares issued and outstanding at December 31, 2021 and 2020, respectively 5 4 Additional paid-in-capital 108,570 100,204 Accumulated other comprehensive loss (55) (27) Accumulated deficit (61,680) (64,689) Total stockholders’ equity 46,840 35,492 Total liabilities and stockholders’ equity $70,428 $60,613