
Investors
News Release Details
Opiant Pharmaceuticals Reports Fourth Quarter and Full-Year 2020 Financial Results and Provides Corporate Update
Pipeline Update
- Continue to advance OPNT003, nasal nalmefene, for opioid overdose, with significant clinical and regulatory milestones expected in 2021
- Confirmatory pharmacokinetic (“PK”) study
- Anticipate full enrollment
April 2021 - Top-line data anticipated in
June 2021
- Anticipate full enrollment
- Pharmacodynamic (“PD”) study
- Protocol filed with
U.S. Food and Drug Administration (“FDA”) Received Institutional Review Board (“IRB”) approval to initiate trial- Anticipate commencing patient dosing
mid-March 2021 - Top-line data expected by the start of the fourth quarter 2021
- Protocol filed with
- The Company remains on track to complete its New Drug Application (“NDA”) submission for use of OPNT003 in opioid overdose by end 2021
- In December, the Company announced an additional commitment of up to
$3.5 million from theBiomedical Advanced Research and Development Authority (“BARDA”) for the development of OPNT003
- Confirmatory pharmacokinetic (“PK”) study
- Pre-clinical progress on OPNT004, drinabant, for Acute Cannabinoid Overdose (“ACO”)
- Formulation development studies commenced
December 2020 in collaboration withNational Center for Advancing Translational Sciences (“NCATS”) - NCATS awarded the contract for formulation activities to
Irisys LLC
- Formulation development studies commenced
- Phase 2 study of OPNT002, nasal naltrexone, for Alcohol Use Disorder (“AUD”), remains on temporary hold due to the ongoing COVID-19 pandemic
Financial Highlights
- Q4 revenues of
$10.0 million and full-year net revenues of$29.6 million driven by royalties from the sale of NARCAN® Nasal Spray (“NARCAN®”) - In December, Opiant entered into a strategic convertible debt financing agreement with a syndicate comprised of
Pontifax Medison Finance and Kreos Capital through which the Company will have access to up to$50 million ; the first tranche of $20 million was funded at closing onDecember 10, 2020 $48.3 million in cash and cash equivalents atDecember 31, 2020 , inclusive of the first tranche of $20 million received from the convertible debt financing closed inDecember 2020 , compared to$31.1 million atDecember 31, 2019
Commenting,
“We are excited to start 2021 by announcing important clinical progress with OPNT003, nasal nalmefene, for opioid overdose. We are nearing completion of our confirmatory PK study and intend to begin our PD study mid-March. Importantly, we expect top-line data from both of these studies later this year, and we remain on track to complete our NDA for the use of OPNT003 in opioid overdose for FDA review by the end of 2021. Opioid overdose continues to be a growing and devastating epidemic in need of effective treatment solutions. Opiant’s purpose – to develop new medicines to treat addictions and drug overdose – has never been more relevant.”
David O’Toole, Chief Financial Officer of Opiant, said:
“As we move into 2021, we maintain a strong cash position, driven by a focus on responsible cost containment, as well as continued royalties on net sales of NARCAN® Nasal Spray. We also locked in an attractive cost of financing with a convertible debt deal for up to
Financial Results for the Fourth Quarter Ended December 31, 2020
For the three months ended December 31, 2020, Opiant recorded approximately $10.0 million in revenue, compared to approximately $7.7 million during the corresponding period of 2019. For the three months ended December 31, 2020, we recorded approximately $8.3 million of revenue from our license agreement with EBS for the sale of NARCAN®, compared to approximately $7.2 million in the same period of 2019. Fourth quarter 2020 sales of NARCAN® were approximately $77.4 million, as reported by EBS.
For the three months ended December 31, 2020, general and administrative (“G&A”) expenses were approximately $3.6 million, compared to
Research and development (“R&D”) expenses for the three months ended
Sales and marketing (“S&M”) expenses for the three months ended
Royalty expense for the three months ended
Net loss for the three months ended December 31, 2020, was approximately $0.6 million, or a loss of
Financial Results for the Year Ended December 31, 2020
For the year ended December 31, 2020, Opiant recorded approximately $29.6 million in revenue, compared to approximately $40.5 million during the corresponding period of 2019. For the year ended December 31, 2020, we recorded approximately $27.4 million of revenue from our license agreement with EBS for the sale of NARCAN®, compared to approximately $37.6 million in the same period of 2019 which included a final milestone payment of
G&A expenses for the year ended December 31, 2020, were approximately $11.7 million, compared to approximately $12.2 million in the comparable period of 2019. The decrease of
R&D expenses for the year ended December 31, 2020, were approximately $9.2 million, compared to approximately $9.1 million in the comparable period of 2019. The increase in R&D expenses is attributable to a
S&M expenses for the year ended
Royalty expense for the year ended
Net loss for the year ended December 31, 2020, was approximately $1.9 million, or a loss of
In December, the Company announced that it had entered into a $50 million convertible Note Purchase and Security Agreement with a syndicate of Pontifax Medison Finance, a healthcare-dedicated venture and debt fund, and Kreos Capital VI (
As of December 31, 2020, Opiant had cash and cash equivalents of $48.3 million, inclusive of the first tranche of $20 million received from the convertible debt financing closed in
Based on the mid-range of the full-year 2021 guidance for sales of NARCAN® Nasal Spray provided by EBS, of
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Webcast: | http://ir.opiant.com/ |
About Opiant Pharmaceuticals, Inc.
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 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, 2020, filed with the Securities and Exchange Commission on March 4, 2021, 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
Batkins@opiant.com
(310) 598-5410
Consolidated Balance Sheets | ||||||||||
(in thousands, except shares and per share amounts) | ||||||||||
As of |
As of |
|||||||||
2020 | 2019 | |||||||||
Assets | ||||||||||
Current Assets | ||||||||||
Cash & cash Equivalents | $ | 48,251 | $ | 30,981 | ||||||
Accounts receivable | 8,911 | 7,218 | ||||||||
Prepaid expenses and other current assets | 1,937 | 1,056 | ||||||||
Total Current Assets | 59,099 | 39,255 | ||||||||
Long-term Assets | ||||||||||
Property and equipment, net | 171 | 243 | ||||||||
Right of use assets - operating leases | 279 | 769 | ||||||||
Patents and patent applications, net | 13 | 14 | ||||||||
Other non-current assets | 1,051 | - | ||||||||
Total Assets | $ | 60,613 | $ | 40,281 | ||||||
Liabilities and stockholders' equity | ||||||||||
Current Liabilities | ||||||||||
Accounts payable and accrued liabilities | $ | 2,966 | $ | 1,317 | ||||||
Accrued salaries and wages | 909 | 1,238 | ||||||||
Royalty payable | 1,908 | 1,620 | ||||||||
Deferred revenue | 355 | 918 | ||||||||
Operating leases - current | 282 | 517 | ||||||||
Total Current Liabilities | 6,420 | 5,610 | ||||||||
Long-Term Liabilities | ||||||||||
Operating leases - long term | - | 255 | ||||||||
Convertible debt, net of issuance costs | 18,701 | - | ||||||||
Total Long-Term Liabilities | 18,701 | 255 | ||||||||
Total Liabilities | 25,121 | 5,865 | ||||||||
Stockholders' equity | ||||||||||
Common stock, |
||||||||||
authorized, 4,258,105 and 4,186,438 shares | ||||||||||
issued and outstanding at |
||||||||||
respectively | 4 | 4 | ||||||||
Additional paid-in-capital | 100,204 | 97,240 | ||||||||
Accumulated other comprehensive loss | (27 | ) | - | |||||||
Accumulated deficit | (64,689 | ) | (62,828 | ) | ||||||
Total stockholders' equity | 35,492 | 34,416 | ||||||||
Total liabilities and stockholders' equity | $ | 60,613 | $ | 40,281 | ||||||
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 | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||||
Revenues | ||||||||||||||||||
Royalty & licensing revenue | $ | 27,402 | $ | 37,592 | $ | 8,345 | $ | 7,224 | ||||||||||
Treatment investment income | - | 644 | - | - | ||||||||||||||
Grant and contract revenue | 2,223 | 2,284 | 1,579 | 446 | ||||||||||||||
Total Revenue | 29,625 | 40,520 | 9,924 | 7,670 | ||||||||||||||
Operating Expenses | ||||||||||||||||||
General and administrative | 11,742 | 12,197 | 3,604 | 2,807 | ||||||||||||||
Research and development | 9,240 | 9,079 | 4,477 | 2,036 | ||||||||||||||
Royalty expense | 6,197 | 7,720 | 1,908 | 1,621 | ||||||||||||||
Sales & Marketing | 4,687 | 612 | 949 | 471 | ||||||||||||||
Total expenses | 31,866 | 29,608 | 10,938 | 6,935 | ||||||||||||||
Operating income (loss) | (2,241 | ) | 10,912 | (1,014 | ) | 735 | ||||||||||||
Other income (expense) | ||||||||||||||||||
Interest income, net | 94 | 438 | 2 | 81 | ||||||||||||||
Interest expense | (131 | ) | - | (131 | ) | - | ||||||||||||
Gain (loss) on settlement of accrued liability | - | 16 | - | 16 | ||||||||||||||
Gain (loss) on foreign exchange | (9 | ) | 50 | (7 | ) | 115 | ||||||||||||
Total other income | (46 | ) | 504 | (136 | ) | 212 | ||||||||||||
Net income (loss) before income taxes | (2,287 | ) | 11,416 | (1,150 | ) | 947 | ||||||||||||
Income tax benefit | 426 | 177 | 465 | 121 | ||||||||||||||
Net income (loss) | $ | (1,861 | ) | $ | 11,593 | $ | (685 | ) | $ | 1,068 | ||||||||
Other comprehensive income (loss) | ||||||||||||||||||
Foreign currency translation adjustment | (27 | ) | - | 88 | - | |||||||||||||
Total other comprehensive income (loss) | $ | (1,888 | ) | $ | 11,593 | $ | (597 | ) | $ | 1,068 | ||||||||
Net income (loss) per common share | ||||||||||||||||||
Basic | $ | (0.44 | ) | $ | 2.88 | $ | (0.16 | ) | $ | 0.26 | ||||||||
Diluted | $ | (0.44 | ) | $ | 2.17 | $ | (0.16 | ) | $ | 0.20 | ||||||||
Weighted-average common shares outstanding: | ||||||||||||||||||
Basic | 4,249,832 | 4,018,464 | 4,258,105 | 4,068,417 | ||||||||||||||
Diluted | 4,249,832 | 5,342,378 | 4,258,105 | 5,472,139 | ||||||||||||||
Source: Opiant Pharmaceuticals, Inc.