News Release Details
Opiant Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Corporate Update
“We remain focused on advancing our robust pipeline, which is funded through multiple government sources and a growing revenue stream via royalties from net sales of NARCAN® Nasal Spray for the reversal of opioid overdose,” said
David O’Toole, Chief Financial Officer of Opiant, added, “I am extremely pleased to report that, based on net sales of NARCAN® Nasal Spray exceeding
Corporate Highlights and Near-Term Milestones
- Earned a one-time $13.5 million milestone payment based on net sales of NARCAN® exceeding
$200 millionthrough the quarter ended September 30, 2019.
- Continued preparations to conduct confirmatory pharmacokinetic (PK) study of nasal nalmefene, OPNT003, for the treatment of opioid overdose.
- Opiant now expects to report top-line data from the PK study in the first quarter of next year, but continues to anticipate filing a New Drug Application for OPNT003 in the fourth quarter of 2020.
- Dose selection study for OPNT002 for Alcohol Use Disorder is nearing completion. Opiant expects to complete the subsequent Phase 2 study during the second half of 2020.
- Strengthened the executive management team with the appointments of
Aziz Mottiwalaas Chief Commercial Officer, and Rahsaan Thompson, as General Counsel.
- Provided a detailed overview of Opiant’s development programs during an
Investor Research & Developmentmeeting in New York City.
- Expanded relationship with Sanofi to include manufacturing of OPNT004 for the emergency treatment of Acute Cannabinoid Overdose. Opiant intends to initiate formulation development studies in the second half of 2019, with clinical trials to follow.
Financial Results for the Third Quarter Ended September 30, 2019
For the three months ended September 30, 2019, Opiant recorded approximately $20.6 million in revenue, compared to approximately $4.4 million during the corresponding period of 2018. For the three months ended September 30, 2019, Opiant recognized approximately $20.5 million of revenue from the license agreement (the Adapt License) between it and Adapt Pharma Operations Limited, now a subsidiary of Emergent BioSolutions Inc. (EBS), for the sale of NARCAN® Nasal Spray, compared to approximately $4.2 million in the comparable period of 2018. The
General and administrative expenses for the three months ended September 30, 2019, were approximately $3.2 million, compared to approximately $2.9 million in the comparable period of 2018. The increase was primarily due to a
Research and development expenses for the three months ended
Sales and marketing expenses for the three months ended
Royalty expense for the three months ended
Net income for the three months ended September 30, 2019, was approximately $10.7 million, or $2.64 per basic and $1.97 per diluted share, compared to a net loss of approximately ($0.9) million, or a loss of (
Financial Results for the Nine Months Ended September 30, 2019
For the nine months ended September 30, 2019, Opiant recorded approximately $32.9 million in revenue, compared to approximately $9.2 million during the corresponding period of 2018. For the nine months ended September 30, 2019, Opiant recognized approximately $30.4 million of revenue from the license agreement between it and Adapt for the sale of NARCAN® Nasal Spray, compared to approximately $8.9 million in the comparable period of 2018. The $21.5 million increase in royalty revenue was attributable to a significant increase in sales of NARCAN® Nasal Spray to approximately $213.5 million for the nine months ended September 30, 2019, as reported by EBS, as well as the one-time milestone payment of
General and administrative expenses for the nine months ended September 30, 2019, were approximately $9.4 million, compared to approximately $8.7 million in the comparable period of 2018. The increase was primarily due to an increase of
Research and development expenses for the nine months ended September 30, 2019, were approximately $7.0 million, compared to approximately $5.9 million in the comparable period of 2018. The increase was primarily attributable to an increase of
Sales and marketing expenses for the nine months ended
Royalty expense for the nine months ended
There were no license fees recorded for the nine months ended
Net income for the nine months ended September 30, 2019, was approximately $10.5 million, or
As of September 30, 2019, Opiant had cash and cash equivalents of $23.2 million, compared to approximately $24.6 million at December 31, 2018. The cash balance at September 30, 2019, does not include the one-time milestone payment of $13.5 million due to Opiant from EBS based on net sales of NARCAN® Nasal Spray exceeding $200 million in the third quarter of 2019, as reported by EBS. Pursuant to Opiant’s license agreement with EBS, EBS will reduce the amount payable to Opiant by the remaining $2.7 million of the license fees payable. Opiant will receive the net sales milestone of
|Conference Call Details:
Thursday, November 12 at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time
About Opiant Pharmaceuticals, Inc.
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 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, 2018, filed with the Securities and Exchange Commission on March 21, 2019, 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.
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|Opiant Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except shares and per share amounts)
|As of September 30,||As of December 31,|
|Cash & cash equivalents||$||23,222||$||24,614|
|Prepaid expenses and other current assets||940||267|
|Total Current Assets||40,230||29,370|
|Property and equipment, net of depreciation||274||-|
|Right of use assets - operating leases||849||-|
|Patents and patent applications, net||15||16|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||1,952||$||1,133|
|Accrued salaries & wages||1,129||1,084|
|Operating leases - current||493||-|
|Total Current Liabilities||9,404||9,827|
|Operating leases - long term||358||-|
|Total Long-Term Liabilities||358||2,700|
|Common stock, $0.001 par value, 200,000,000 shares authorized, 4,074,622 and 3,845,361 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively||4||4|
|Total stockholders' equity||31,606||16,859|
|Total liabilities and stockholders' equity||$||41,368||$||29,386|
|Opiant Pharmaceuticals Inc.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share amounts)
|Three months ended
|Nine months ended
|Royalty & licensing revenue||20,494||4,185||30,369||8,887|
|Treatment investment revenue||-||63||644||170|
|General and administrative||3,210||2,861||9,389||8,683|
|Research and development||1,843||1,908||7,044||5,945|
|Sales and marketing||141||-||141||-|
|Income (loss) from operations||10,596||(940||)||10,178||(11,570||)|
|Other income (expense)|
|Loss on settlement of liability||-||-||-||(50||)|
|Gain (loss) on foreign exchange||(24||)||2||(65||)||(36||)|
|Total other income (expense)||88||22||291||(55||)|
|Income (loss) before provision for income taxes||10,684||(918||)||10,469||(11,625||)|
|Income tax (expense) benefit||-||-||57||(33||)|
|Net income (loss)||$||10,684||$||(918||)||$||10,526||$||(11,658||)|
|Net income (loss) per common share|
|Weighted-average common shares outstanding:|
Source: Opiant Pharmaceuticals, Inc.