UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 11, 2016
Insys Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
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001-35902 |
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51-0327886 |
(State or other jurisdiction of incorporation) |
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(Commission File No.) |
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(IRS Employer Identification No.) |
1333 S. Spectrum Blvd, Suite 100
Chandler, Arizona 85286
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (602) 910-2617
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On April 11, 2016, Insys Therapeutics, Inc. (the “Company”) issued a press release announcing its preliminary estimate of revenues for the first quarter ended March 31, 2016. A copy of this press release is attached hereto as Exhibit 99.1.
The information in this Item 2.02 and Exhibit 99.1 hereto are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No. Description
99.1 Press Release dated April 11, 2016
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: April 11, 2016 |
Insys Therapeutics, Inc. | |
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By: |
/s/ Darryl S. Baker |
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Darryl S. Baker |
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Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. Description
99.1 Press Release dated April 11, 2016
Exhibit 99.1
For Immediate Release
Insys Therapeutics Reports Preliminary Estimated Revenues from Subsys
for the First Quarter 2016
PHOENIX, AZ— April 11, 2016 - Insys Therapeutics, Inc. (NASDAQ: INSY) ("Insys" or "the Company") today announced that its preliminary estimated revenues from Subsys® (fentanyl sublingual spray) for the first quarter of 2016 will be in the range of $61 million to $62 million. Estimated revenues for the quarter reflect a decline in demand, as Subsys prescription volumes were down, as well as a reduction in wholesale inventory levels. The Company estimates the decrease in wholesale channel inventory levels to be in the range of $7 million.
The Company believes that heightened publicity surrounding the national opioid epidemic has resulted in a sensitivity by some healthcare providers to prescribe opioids. The Company expects the Subsys prescription decline is close to stabilizing. At the current sales levels, the Company believes it will remain profitable and intends to pursue all of its research and development projects.
Today’s preliminary estimate of revenues from Subsys, which is unaudited, is based on management's preliminary financial analysis.
About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. Insys currently markets one product, Subsys® (fentanyl sublingual spray). The Company recently submitted a New Drug Application to the U.S. Food and Drug Administration for Syndros™ (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule. Insys is developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol.
Subsys® and Syndros™ are trademarks of Insys Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements including (i) our preliminary estimate of first quarter 2016 revenue and the financial analysis related thereto, (ii) the Company’s belief that the opioid epidemic has resulted in a sensitivity by some healthcare providers to prescribe opioids; (iii) the Company’s belief that prescription trends indicate Subsys is close to stabilizing; and (iv) the Company’s belief that it will be profitable and will continue to pursue all of its research and development projects. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to risk factors described in the Company’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
Contact:
Lisa M. Wilson
President
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
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