- OPNT003 nasal nalmefene for opioid overdose
- Opiant to use Aptar Pharma’s Unit Dose System
- Upcoming FDA meeting in December to review Pharmacodynamic study in healthy volunteers and 505(b)(2) submission strategy
- Opiant continues to expect to file a New Drug Application by end of 2021
- TheCenters for Disease Control and Prevention reports an increase in fatal drug overdoses in the first three months of 2020 putting theU.S. on pace for record year of drug overdose deaths during coronavirus pandemic
- Q3 revenues of
$9.1 million driven by NARCAN® Nasal Spray (“NARCAN®”) royalties
- Recognized approximately $8.6 million in royalty revenue for Q3 2020 from approximately $88.8 million in net sales of NARCAN® Nasal Spray
- Projected royalties for the full-year 2020 raised from$26.2 million to approximately$28 million , based on Emergent Biosolutions (“EBS”) updated revenue guidance for NARCAN® sales of between$295 million and$315 million
$31.1 million in cash and cash equivalents
Commenting on the quarter,
“Deaths from overdoses on opioids remain a crisis for communities across
David O’Toole, Chief Financial Officer of Opiant, said:
“Royalties from net sales of NARCAN® Nasal Spray continue to fortify our already strong balance sheet. EBS reported higher sales than expected this quarter and raised their NARCAN® revenue guidance for the year to a range of
Third Quarter 2020 Results
For the three months ended September 30, 2020, Opiant recorded approximately $9.1 million in revenue, compared to approximately $20.6 million during the corresponding period of 2019. For the three months ended September 30, 2020, we recorded approximately $8.6 million of revenue from our license agreement with EBS for the sale of NARCAN®, compared to approximately $20.5 million in the same period of 2019 which included a final milestone payment of
General and administrative expenses for the quarter were approximately $2.7 million, compared to
Research and development expenses were approximately $2.8 million, as compared to approximately
Sales and marketing expenses were approximately $0.9 million, as compared to approximately
Royalty expense for the second quarter was approximately
Net income for the third quarter was approximately $0.7 million, or $0.17 per basic and
Financial Results for the Nine Months Ended September 30, 2020
For the nine months ended September 30, 2020, Opiant recorded approximately $19.7 million in revenue, compared to approximately $32.9 million during the corresponding period of 2019. For the nine months ended September 30, 2020, we recognized approximately $19.1 million of revenue from our license agreement with EBS for the sale of NARCAN®, compared to approximately $30.4 million in the comparable period of 2019. The decrease in revenue of approximately
General and administrative expenses for the nine months ended September 30, 2020, were approximately $8.1 million, compared to approximately $9.4 million in the comparable period of 2019. The decrease of
Research and development expenses for the nine months ended September 30, 2020, were approximately $4.8 million, compared to approximately $7.0 million in the comparable period of 2019. The decrease of
Sales and marketing expenses for the nine months ended September 30, 2020, were approximately
Royalty expenses were
Net loss for the nine months ended September 30, 2020, was approximately $1.2 million, or a loss of $0.28 per basic and diluted share, compared to a net income of approximately $10.6 million, or
As of September 30, 2020, Opiant had cash and cash equivalents of $31.1 million, compared to approximately $31 million at December 31, 2019. The current cash balance does not include the full impact of the NIDA grant that we previously received of approximately $7.4 million or the BARDA contract of approximately $4.6 million.
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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, 2019, filed with the Securities and Exchange Commission on March 4, 2020, 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
Managing Director
Daniel@lifesciadvisors.com
(617) 430-7576
Condensed Consolidated Balance Sheets | ||||||||
(in thousands, except shares and per share amounts) | ||||||||
As of | As of | |||||||
2020 | 2019 | |||||||
Assets | (unaudited) | |||||||
Current Assets | ||||||||
Cash & cash equivalents | $ | 31,103 | $ | 30,981 | ||||
Accounts receivable | 8,613 | 7,218 | ||||||
Prepaid expenses and other current assets | 862 | 1,056 | ||||||
Total Current Assets | 40,578 | 39,255 | ||||||
Long-term Assets | ||||||||
Property and equipment, net of depreciation | 202 | 243 | ||||||
Right of use assets - operating leases | 397 | 769 | ||||||
Patents and patent applications, net of amortization | 13 | 14 | ||||||
Other non-current assets | 1,052 | - | ||||||
Total Assets | $ | 42,242 | $ | 40,281 | ||||
Liabilities and stockholders' equity | ||||||||
Current Liabilities | ||||||||
Accounts payable and accrued expenses | $ | 2,553 | $ | 1,317 | ||||
Accrued salaries & wages | 1,435 | 1,238 | ||||||
Royalty payable | 1,952 | 1,620 | ||||||
Deferred revenue | 360 | 918 | ||||||
Operating leases - current | 401 | 517 | ||||||
Total Current Liabilities | 6,701 | 5,610 | ||||||
Long-Term Liabilities | ||||||||
Operating leases - long term | - | 255 | ||||||
Total Long-Term Liabilities | - | 255 | ||||||
Total Liabilities | 6,701 | 5,865 | ||||||
Stockholders' equity | ||||||||
Common stock, | ||||||||
authorized, 4,258,105 and 4,186,438 shares | ||||||||
issued and outstanding at | ||||||||
4 | 4 | |||||||
Additional paid-in-capital | 99,655 | 97,239 | ||||||
Foreign Currency Translation Adjustment | (115 | ) | - | |||||
Accumulated deficit | (64,003 | ) | (62,827 | ) | ||||
Total stockholders' equity | 35,541 | 34,416 | ||||||
Total liabilities and stockholders' equity | $ | 42,242 | $ | 40,281 |
Condensed Consolidated Statements of Operations | ||||||||||||||||
(in thousands, except shares and per share amounts) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three months ended | Nine months ended | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Revenues | ||||||||||||||||
Royalty & licensing revenue | $ | 8,601 | $ | 20,494 | $ | 19,057 | $ | 30,368 | ||||||||
Treatment investment revenue | - | - | - | 644 | ||||||||||||
Grant and contract revenue | 505 | 147 | 644 | 1,838 | ||||||||||||
Total Revenue | 9,106 | 20,641 | 19,701 | 32,850 | ||||||||||||
Operating expenses | ||||||||||||||||
General and administrative | 2,729 | 3,211 | 8,138 | 9,389 | ||||||||||||
Research and development | 2,784 | 1,843 | 4,763 | 7,044 | ||||||||||||
Sales and marketing | 914 | 141 | 3,738 | 141 | ||||||||||||
Royalty expense | 1,952 | 4,851 | 4,289 | 6,099 | ||||||||||||
Total operating expenses | 8,379 | 10,046 | 20,928 | 22,673 | ||||||||||||
Income (loss) from operations | 727 | 10,595 | (1,227 | ) | 10,177 | |||||||||||
Other income (expense) | ||||||||||||||||
Interest income | 4 | 112 | 92 | 356 | ||||||||||||
Gain (loss) on foreign exchange | (6 | ) | (24 | ) | (2 | ) | (65 | ) | ||||||||
Total other income | (2 | ) | 88 | 90 | 291 | |||||||||||
Income (loss) before income taxes | 725 | 10,683 | (1,137 | ) | 10,468 | |||||||||||
Income tax (expense) benefit | - | - | (39 | ) | 57 | |||||||||||
Net income (loss) | $ | 725 | $ | 10,683 | $ | (1,176 | ) | $ | 10,525 | |||||||
Other comprehensive loss | ||||||||||||||||
Foreign currency translation adjustment | 196 | - | (115 | ) | - | |||||||||||
Total other comprehensive loss | $ | 921 | $ | 10,683 | $ | (1,291 | ) | $ | 10,525 | |||||||
Net income (loss) per common share | ||||||||||||||||
Basic | $ | 0.17 | $ | 2.64 | $ | (0.28 | ) | $ | 2.64 | |||||||
Diluted | $ | 0.15 | $ | 1.97 | $ | (0.28 | ) | $ | 1.98 | |||||||
Weighted-average common shares outstanding: | ||||||||||||||||
Basic | 4,258,105 | 4,048,635 | 4,247,045 | 3,985,112 | ||||||||||||
Diluted | 4,847,211 | 5,422,345 | 4,247,045 | 5,310,157 |
Source:
2020 GlobeNewswire, Inc., source