On March 8, 2018 INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported financial results for its fourth quarter and full year ended Dec. 31, 2017 (Press release, Insys Therapeutics, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337183 [SID1234524561]).
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OVERALL HIGHLIGHTS
Achieved gross revenue of $46.1 million, resulting in net revenue of $31.5 million.
Advanced product pipeline with total R&D investment of $16.4 million.
Completed pharmacokinetics (PK) study of naloxone nasal spray as investigational treatment of opioid overdose.
Completed FDA filing of NDA for buprenorphine sublingual spray as investigational treatment for moderate-to-severe acute pain.
Initiated Phase 2 clinical trial of cannabidiol (CBD) oral solution as investigational treatment for medically refractory childhood absence epilepsy.
Enrolled first patient in proof-of-concept study of epinephrine nasal spray as investigational treatment for anaphylaxis.
Received ‘Fast Track’ designation from FDA for CBD oral solution as investigational treatment for Prader-Willi syndrome.
Settled lawsuit with one major health insurer.
"Over the course of 2017, we implemented a series of significant changes that set the foundation for a new strategic direction for the company as a leader in pharmaceutical cannabinoids and spray technologies," said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. "This foundation was built around new leadership and elevated capabilities at all levels of the organization, which has allowed us to aggressively reposition and advance our product pipeline. Most importantly, this foundation establishes an unwavering commitment to enhance the quality of life for underserved patient populations, and we look forward to finding solutions for a number of orphan diseases through our R&D programs."
Motahari continued, "In the fourth quarter, we continued our efforts to stabilize SUBSYS despite the declining market for TIRF medications by securing several managed care wins that went into effect in January 2018. We also continued our controlled rollout of SYNDROS during the period. As a result, we intend to achieve top-line stability in 2018 in parallel with our ongoing transformation of the company."
Motahari concluded, "We believe our R&D in both pharmaceutical cannabinoids and spray technology platforms will propel INSYS to a strong market position for the coming years."
Financial & Operating Highlights
Net revenue for the fourth quarter of 2017 was $31.5 million, compared to $54.9 million for the fourth quarter of 2016.
Gross margin was 85.4 percent for the fourth quarter of 2017, compared to 82.1 percent in the same period of 2016.
Sales and marketing investment was $7.1 million for the fourth quarter of 2017, compared to $13.5 million for the fourth quarter of 2016.
Research and development investment increased to $16.4 million for the fourth quarter of 2017, compared to $15.5 million for the same period in 2016.
General and administrative expense increased to $19.7 million for the fourth quarter of 2017 from $15.8 million for the fourth quarter of 2016.
Income tax expense was $26.8 million for the fourth quarter of 2017 and included a $7.5 million charge related to the change in tax code and $22.6 million of expense to fully reserve our deferred tax assets, compared to an expense of $0.3 million during the fourth quarter of 2016.
Net loss for the fourth quarter of 2017 was $47.0 million, or ($0.65) per basic and diluted share, compared to a net loss of $3.7 million, or ($0.05) per basic and diluted share, for the fourth quarter of 2016.
Adjusted EBITDA loss for the fourth quarter of 2017 was $11.5 million, compared to Adjusted EBITDA of $6.1 million in the prior-year quarter. The reconciliation of net income to Adjusted EBITDA is included at the end of this news release.
The company had $163.9 million in cash, cash equivalents, and short-term and long-term investments with no debt as of Dec. 31, 2017.
Webcast Information
A conference call is scheduled for 5:00 p.m. Eastern Standard Time on March 8, 2018, to discuss the financial and operational results for the fourth quarter of and full year 2017. Interested parties can listen to the call live via the company’s website, View Source, on the INVESTORS section Presentations & Events page; or by dialing 844-263-8304 (from inside the U.S.) or 213-358-0958 (from outside the U.S.). A webcasted replay of the call will be available on the site a few hours after the event.