Opiant Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2017 Financial Results and Provides Corporate Update
“Since the beginning of our fiscal second quarter, we have made significant progress on a number of corporate and clinical initiatives designed to establish a foundation for future growth,” said
Fiscal Second Quarter 2017 and Recent Highlights
- Signed a definitive agreement with SWK Holdings Corporation (“SWK”), in which SWK acquired rights to certain royalties and milestone payments related to the sales of NARCAN® Nasal Spray (NARCAN®) for the treatment of opioid overdose for up to $17.5 million. Opiant received $13.7 million at closing and is eligible to receive an additional $3.75 million contingent on the achievement of certain future net sales milestones. After SWK has received 1.5 times its investment, Opiant will receive at least 90% of future NARCAN® royalties and milestone payments.
- Strengthened intellectual property estate and enhanced NARCAN® product exclusivity with the addition of two Orange Book-listed patents. There are now four Orange Book-listed patents covering NARCAN®.
- Generated encouraging Phase 1 data and received supportive
U.S. Food and Drug Administration (FDA ) feedback on a proposed clinical development plan for OPNT002 for treatment of Alcohol Use Disorder (AUD).
- Received
FDA approval for the 2mg formulation of NARCAN® for opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.
- Expanded leadership team through the appointment of
Phil Skolnick , Ph.D., D.Sc. (hon) as Chief Scientific Officer.
- Strengthened corporate governance through the formation of Audit, Compensation and Nominating and Corporate Governance committees.
Upcoming Corporate and Clinical Goals
- During the current fiscal quarter, Opiant expects to initiate a Phase 2 trial of OPNT001 in Bulimia Nervosa.
- During the second half of 2017, Opiant expects to initiate additional clinical trials in AUD.
- During 2017, Opiant plans to pursue an uplisting to a major stock exchange.
- During 2017, Opiant expects to advance pre-clinical development of its heroin vaccine candidate.
Financial Results
Quarter ended
For the quarter ended
Research and development expense in the quarter ended
For the quarter ended
Selling expenses were
Opiant ended the fiscal second quarter 2017 with cash and cash equivalents of
About
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. 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. 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.
Financial tables to follow
Balance Sheets (Unaudited)
As of
| January 31, | July 31, | |||||||
| 2017 | 2016 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 12,925,829 | $ | 1,481,393 | ||||
| Accounts receivable | - | 312,498 | ||||||
| Prepaid expenses | 52,017 | 62,404 | ||||||
| Total current assets | 12,977,846 | 1,856,295 | ||||||
| Other assets | ||||||||
| Computer equipment (net of accumulated amortization of $2,900 at January 31, 2017 and $1,016 at July 31, 2016) | 4,637 | 6,521 | ||||||
| Patents and patent applications (net of accumulated amortization of $9,074 at January 31, 2017 and $8,388 at July 31, 2016) | 18,376 | 19,062 | ||||||
| Total assets | $ | 13,000,859 | $ | 1,881,878 | ||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||
| Liabilities | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 756,212 | $ | 140,584 | ||||
| Accrued salaries and wages | 3,690,289 | 3,681,250 | ||||||
| Note payable | - | 165,000 | ||||||
| Deferred revenue | 750,000 | 250,000 | ||||||
| Total current liabilities | 5,196,501 | 4,236,834 | ||||||
| Deferred revenue | 1,850,000 | 2,350,000 | ||||||
| Total liabilities | 7,046,501 | 6,586,834 | ||||||
| Stockholders' equity (deficit) | ||||||||
| Common stock; par value $0.001; 1,000,000,000 shares authorized; | ||||||||
| 2,007,760 shares issued and outstanding at January 31, 2017 and 1,992,433 shares issued and outstanding at July 31, 2016 | 2,008 | 1,992 | ||||||
| Additional paid-in capital | 57,088,530 | 56,478,394 | ||||||
| Accumulated deficit | (51,136,180 | ) | (61,185,342 | ) | ||||
| Total stockholders' equity (deficit) | 5,954,358 | (4,704,956 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 13,000,859 | $ | 1,881,878 | ||||
| The accompanying notes are an integral part of these unaudited consolidated financial statements. | ||||||||
Statements of Operations (Unaudited)
For the three and six months ended
| For the | For the | |||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| January 31, | January 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue | ||||||||||||||||
| Royalty and licensing revenue | $ | 13,535,000 | $ | 6,860,000 | $ | 14,656,142 | $ | 6,980,000 | ||||||||
| 13,535,000 | 6,860,000 | 14,656,142 | 6,980,000 | |||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | 1,355,704 | 2,394,505 | 2,572,006 | 12,990,324 | ||||||||||||
| Research and development | 344,836 | 254,881 | 786,670 | 879,892 | ||||||||||||
| Selling expenses | 1,196,563 | 209,251 | 1,238,599 | 209,251 | ||||||||||||
| Total operating expenses | 2,897,103 | 2,858,637 | 4,597,275 | 14,079,467 | ||||||||||||
| Income (loss) from operations | 10,637,897 | 4,001,363 | 10,058,867 | (7,099,467 | ) | |||||||||||
| Other income (expense) | ||||||||||||||||
| Interest income (expense), net | 877 | (5,491 | ) | (1,367 | ) | (11,319 | ) | |||||||||
| Income (loss) on foreign exchange | 11,016 | (25,832 | ) | (8,338 | ) | (29,191 | ) | |||||||||
| Total other income (expense) | 11,893 | (31,323 | ) | (9,705 | ) | (40,510 | ) | |||||||||
| Income (loss) before provision for income taxes | 10,649,790 | 3,970,040 | 10,049,162 | (7,139,977 | ) | |||||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net income (loss) | $ | 10,649,790 | $ | 3,970,040 | $ | 10,049,162 | $ | (7,139,977 | ) | |||||||
| Basic income (loss) per common share | $ | 5.31 | $ | 2.11 | $ | 5.03 | $ | (3.83 | ) | |||||||
| Diluted income (loss) per common share | $ | 4.91 | $ | 1.52 | $ | 4.55 | $ | (3.83 | ) | |||||||
| Basic weighted average common shares outstanding | 2,006,181 | 1,880,279 | 1,999,307 | 1,865,230 | ||||||||||||
| Diluted weighted average common shares outstanding | 2,169,966 | 2,605,270 | 2,210,990 | 1,865,230 | ||||||||||||
| The accompanying notes are an integral part of these unaudited consolidated financial statements. | ||||||||||||||||
Statements of Cash Flows (Unaudited)
For the six months ended
| For the | ||||||||
| Six Months Ended | ||||||||
| January 31, | January 31, | |||||||
| 2017 | 2016 | |||||||
| Cash flows used in operating activities | ||||||||
| Net income (loss) | $ | 10,049,162 | $ | (7,139,977 | ) | |||
| Adjustments to reconcile net loss to net cash used by operating activities: | ||||||||
| Depreciation and amortization | 2,570 | 686 | ||||||
| Issuance of common stock for services | 92,623 | 456,483 | ||||||
| Stock based compensation from issuance of options | 517,529 | 10,166,391 | ||||||
| Changes in assets and liabilities: | ||||||||
| Decrease in prepaid expenses | 10,387 | 6,060 | ||||||
| Increase in accounts receivable | 312,498 | - | ||||||
| Decrease in deferred revenue | - | (4,300,000 | ) | |||||
| Increase (decrease) in accounts payable | 615,628 | (280,245 | ) | |||||
| Increase in accrued salaries and wages | 9,039 | 734,441 | ||||||
| Net cash provided by (used in) operating activities | 11,609,436 | (356,161 | ) | |||||
| Cash flows provided by financing activities | ||||||||
| Proceeds from related parties notes payable | - | 151,191 | ||||||
| Payments of related parties notes payable | - | (281,191 | ) | |||||
| Repayment of notes payable | (165,000 | ) | - | |||||
| Investment received in exchange for royalty agreement | - | 1,333,500 | ||||||
| Net cash provided by (used in) financing activities | (165,000 | ) | 1,203,500 | |||||
| Net increase in cash and cash equivalents | 11,444,436 | 847,339 | ||||||
| Cash and cash equivalents, beginning of period | 1,481,393 | 434,217 | ||||||
| Cash and cash equivalents, end of period | $ | 12,925,829 | $ | 1,281,556 | ||||
| Supplemental disclosure | ||||||||
| Interest paid during the period | $ | 4,828 | $ | 78,865 | ||||
| Taxes paid during the period | $ | - | $ | - | ||||
| The accompanying notes are an integral part of these unaudited consolidated financial statements. | ||||||||
CONTACT INFORMATION: Corporate Contact: Investor.relations@opiant.com Media:Susan Forman DGI sforman@dgicomm.com 212-825-3210 Investors:Sam Martin Managing DirectorArgot Partners sam@argotpartners.com 212-600-1902