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8-K - FORM 8-K - Insys Therapeutics, Inc.insy20161102_8k.htm

Exhibit 99.1

 

 

  

For Immediate Release

 

Insys Therapeutics Reports Third Quarter 2016 Results

 

PHOENIX, Ariz. — November 3, 2016— Insys Therapeutics, Inc. (NASDAQ: INSY) ("Insys" or "the Company") today announced financial results for the three-month period ended September 30, 2016.

 

Highlights of and subsequent to the third quarter of 2016 include:

 

 

Total net revenue was $55.2 million, compared to $91.3 million for the third quarter of 2015;

 

 

Net income totaled $190,000, or $0.00 per basic and $0.00 per diluted share, compared to net income of $26.1 million, or $0.36 per basic and $0.34 per diluted share, for the third quarter of 2015;

 

 

Cash, cash equivalents and investments were $217.2 million as of September 30, 2016; and

 

 

Insys received FDA approval for the marketing of SyndrosTM (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol.

 

“Although Subsys volumes declined in the quarter, we are pleased to have maintained a mid-40% market share and believe the product will continue to provide a solid financial foundation for growth and to support our R&D efforts,” said Dr. John N. Kapoor, Chairman, President and Chief Executive Officer of Insys Therapeutics. “We are currently awaiting DEA scheduling of Syndros, our recently FDA approved product for cancer induced nausea and vomiting and anorexia associated with weight loss in AIDS patients. We look forward to launching Syndros, our second commercial product, which we believe has distinct advantages over the current formulation of dronabinol in soft gel capsule. We remain excited about our pipeline and believe that both our spray and cannabinoid platform products will provide opportunities for future growth,” he concluded.

 

Third Quarter 2016 Financial Results

 

Net revenue for the third quarter of 2016 was $55.2 million compared to $91.3 million for the third quarter of 2015, a decrease of 39.5%. The results reflect a decline in Subsys prescription volumes due to softness in overall demand in the TIRF category, including Subsys, and continued pressure from third-party payers.

 

 
 

 

  

Gross margin was 92% for the third quarter of 2016 compared with 92% for the comparable quarter of 2015.

 

Sales and marketing expense was $16.7 million during the third quarter of 2016, or 30% of net revenue, compared to $19.2 million, or 21% of net revenue, for the third quarter of 2015.

 

Research and development expense increased to $16.5 million for the third quarter of 2016, compared to $12.3 million for the third quarter of 2015, as we continue to advance the multistage products in our pipeline.

 

General and administrative expense increased to $17.7 million for the third quarter of 2016, up from $13.7 million for the third quarter of 2015, and included a non-cash equity compensation charge of approximately $4 million in connection with the departure of a former executive.

 

Net income for the third quarter of 2016 was $190,000, or $0.00 per basic and $0.00 per diluted share, compared to net income of $26.1 million, or $0.36 per basic and $0.34 per diluted share, for the third quarter of 2015. Non-GAAP adjusted net income for the third quarter of 2016 was $5.0 million, or $0.07 per diluted share, compared to non-GAAP adjusted net income of $38.0 million, or $0.50 per diluted share, in the prior-year quarter. The reconciliation of net income to non-GAAP adjusted net income is included at the end of this press release.

 

Liquidity

 

The Company had $217.2 million in cash, cash equivalents, and short-term and long-term investments, no debt, and $269 million in stockholders' equity as of September 30, 2016.

 

Conference Call

 

Insys management will host its third quarter 2016 conference call as follows:

 

Date: Thursday, November 3, 2016

Time: 10:00 a.m. EDT
Toll free (U.S):
(844) 263-8304
International:
(213) 358-0958
Live webcast
www.insysrx.com under the “Investor Relations” section

 

A telephone replay will be available shortly after the completion of the call for one week by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International) and entering conference call ID number 9540411.

 

A live audio webcast and archive of the call will also be available at www.insysrx.com.

 

 
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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) but has received approval for the marketing of SyndrosTM (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. Insys is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with high unmet need.

 

Subsys® and SyndrosTM are trademarks of Insys Therapeutics, Inc.

 

Forward-Looking Statements 

 

This press release contains forward-looking statements including regarding our (i) belief that Subsys will continue to provide a very solid financial foundation for growth and to support our R&D efforts, (ii) belief that Syndros has distinct advantages over the current formulation of dronabinol in soft gel capsule, (iii) belief that our spray and cannabinoid platform products will provide opportunities for future growth and (iv) our belief that our non-GAAP measures can be a meaningful indicator to both our management and investors. 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 our 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.

 

Non-GAAP Financial Measures

 

In addition to reporting all financial information required in accordance with accounting principles generally accepted in the United States of America(GAAP), the Company is also reporting Adjusted EBITDA, Adjusted net income and Adjusted net income per diluted share, which are non-GAAP financial measures. Since Adjusted EBITDA, Adjusted net income and Adjusted net income per diluted share are not GAAP financial measures, they should not be used in isolation or as a substitute for consolidated statements of comprehensive income (loss) and cash flow data prepared in accordance with GAAP. In addition, the Company's definitions of Adjusted EBITDA, Adjusted net income and Adjusted net income per diluted share may not be comparable to similarly titled non-GAAP financial measures reported by other companies. For a full reconciliation of Adjusted EBITDA and Adjusted net income to GAAP net income, please see the attachments to this earnings release.

 

 
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Adjusted EBITDA, as defined by the Company, is calculated as follows:

 

Net income, plus:

 

 

Interest income (expense), net;

 

 

The recorded provision for income taxes;

 

 

Depreciation and amortization; and

 

 

Non-cash expenses, such as stock compensation expense and accrual for expected litigation judgment.

 

The Company believes that Adjusted EBITDA can be a meaningful indicator, to both Company management and investors, of the past and expected ongoing operating performance of the Company. EBITDA is a commonly used and widely accepted measure of financial performance. Adjusted EBITDA is deemed by the Company to be a useful performance indicator because it includes an add-back of non-cash and non-recurring operating expenses that may be subject to uncontrollable factors not reflective of the Company's true operational performance.

 

Adjusted net income, as defined by the Company, is calculated as follows:

 

Net income, plus:

 

 

The recorded provision for income taxes;

 

 

Non-cash expenses, such as stock compensation expense, non-cash interest, and non-cash other expense (i.e., accrual for expected litigation judgment); and

 

 

Less an estimated cash tax provision, net of the benefit from utilizing NOL carry-forwards and windfalls from employee stock option exercises.

 

Adjusted net income per diluted share is equal to Adjusted net income divided by the diluted share count for the applicable period.

 

 
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The Company believes that Adjusted net income and Adjusted net income per diluted shares are meaningful financial indicators, to both Company management and investors, in that they exclude non-cash income and expense items, as well as other income and expense items that are not expected to recur and therefore are not reflective of continuing operating performance.

 

While the Company uses Adjusted EBITDA, Adjusted net income and Adjusted net income per diluted share in managing and analyzing its business and financial condition and believes these non-GAAP financial measures to be useful to investors in evaluating the Company's performance, each of these financial measures has certain shortcomings. Adjusted EBITDA does not take into account the impact of capital expenditures on either the liquidity or the GAAP financial performance of the Company and likewise omits share-based compensation expenses, which may vary over time and may represent a material portion of overall compensation expense. Adjusted net income does not take into account non-cash expenses that reflect the amortization of past expenditures, or include stock-based compensation, which is an important and material element of the Company's compensation package for its directors, officers and other key employees. As a result of the inherent limitations of each of these non-GAAP financial measures, the Company's management utilizes comparable GAAP financial measures to evaluate the business in conjunction with Adjusted EBITDA, Adjusted net income and Adjusted net income per diluted share and encourages investors to do likewise.

 

— Financial tables follow — 

 

 
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INSYS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED INCOME STATEMENTS

(In thousands, except share and per share amounts)

(unaudited)

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2016

   

2015

   

2016

   

2015

 

Net revenue

  $ 55,180     $ 91,259     $ 184,263     $ 239,663  

Cost of revenue

    4,677       7,707       15,588       22,387  

Gross profit

    50,503       83,552       168,675       217,276  
                                 

Operating expenses:

                               

Sales and marketing

    16,662       19,217       56,153       62,119  

Research and development

    16,516       12,322       59,940       40,720  

General and administrative

    17,653       13,681       46,275       42,212  

Charges related to litigation award

    -       (789 )     -       9,515  

Total operating expenses

    50,831       44,431       162,368       154,566  
                                 

Income (loss) from operations

    (328 )     39,121       6,307       62,710  

Other income (expense),net

    0       (37 )     44       (8 )

Interest income

    281       128       762       360  

Income (loss) before income taxes

    (47 )     39,212       7,113       63,062  

Income tax expense (benefit)

    (237 )     13,084       134       21,596  

Net income

  $ 190     $ 26,128     $ 6,979     $ 41,466  
                                 

Net income per common share:

                               

Basic

  $ 0.00     $ 0.36     $ 0.10     $ 0.58  

Diluted

  $ 0.00     $ 0.34     $ 0.09     $ 0.55  
                                 

Shares used in computing net income per common share:

                               

Basic

    71,640,536       71,905,183       71,592,145       71,446,485  

Diluted

    74,328,963       75,991,330       74,545,823       75,542,173  
                                 
                                 

Percentage of Net revenue:

                               
                                 

Net revenue

    100.0 %     100.0 %     100.0 %     100.0 %

Cost of revenue

    8.5 %     8.4 %     8.5 %     9.3 %

Gross profit

    91.5 %     91.6 %     91.5 %     90.7 %
                                 

Operating expenses:

                               

Sales and marketing

    30.2 %     21.1 %     30.5 %     25.9 %

Research and development

    29.9 %     13.5 %     32.5 %     17.0 %

General and administrative

    32.0 %     15.0 %     25.1 %     17.6 %

Charges related to litigation award

    0.0 %     -0.9 %     0.0 %     4.0 %

Total operating expenses

    92.1 %     48.7 %     88.1 %     64.5 %
                                 

Income from operations

    -0.6 %     42.9 %     3.4 %     26.2 %

Other income (expense),net

    0.0 %     0.0 %     0.0 %     0.0 %

Interest income

    0.5 %     0.1 %     0.4 %     0.2 %

Income before income taxes

    -0.1 %     43.0 %     3.9 %     26.3 %

Income tax expense

    -0.4 %     14.3 %     0.1 %     9.0 %

Net income

    0.3 %     28.6 %     3.8 %     17.3 %

 

 
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INSYS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(unaudited)

 

   

September 30,

   

December 31,

 
   

2016

   

2015

 

ASSETS:

               

Cash and cash equivalents

  $ 93,529     $ 79,515  

Short-term investments

    76,122       79,576  

Accounts receivable, net

    33,911       48,459  

Inventories

    27,982       41,715  

Prepaid expenses and other current assets

    3,684       3,973  

Long-term investments

    47,524       43,219  

Other non-current assets

    70,381       54,739  

Total assets

  $ 353,133     $ 351,196  
                 

LIABILITIES AND STOCKHOLDERS' EQUITY:

               

Liabilities

  $ 84,330     $ 97,494  

Stockholders' equity

    268,803       253,702  

Total liabilities and stockholders' equity

  $ 353,133     $ 351,196  

 
 
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INSYS THERAPEUTICS, INC.

RECONCILIATION OF NET INCOME TO NON-GAAP ADJUSTED EBITDA

(In thousands)

(unaudited)

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2016

   

2015

   

2016

   

2015

 

Net income

  $ 190     $ 26,128     $ 6,979     $ 41,466  

Adjustments to arrive at EBITDA:

                               

Interest (income)

    (281 )     (128 )     (762 )     (360 )

Income tax expense

    (237 )     13,084       134       21,596  

Depreciation and amortization expense

    1,511       1,368       4,534       3,825  

EBITDA

    1,184       40,452       10,884       66,527  

Non-cash stock compensation expense

    8,400       4,321       18,971       12,268  

Charges related to litigation award

    -       (789 )     -       9,515  

Adjusted EBITDA

  $ 9,583     $ 43,984     $ 29,855     $ 88,310  

 

 

 

INSYS THERAPEUTICS, INC.

RECONCILIATION OF NET INCOME TO NON-GAAP ADJUSTED NET INCOME

(In thousands, except per share amounts)

(unaudited)

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2016

   

2015

   

2016

   

2015

 

Net income

  $ 190     $ 26,128     $ 6,979     $ 41,466  

Income tax expense

    (237 )     13,084       134       21,596  

Income (loss) before income taxes

    (47 )     39,212       7,112       63,062  

Adjustments to arrive at Adjusted net income (loss):

                               

Non-cash stock compensation expense

    8,400       4,321       18,971       12,268  

Charges related to litigation award

    -       (789 )     -       9,515  

Adjusted income before income taxes

    8,353       42,744       26,084       84,845  

Adjusted income tax provision

    3,385       4,840       3,385       7,872  

Adjusted net income

  $ 4,968     $ 37,904     $ 22,699     $ 76,973  
                                 

Adjusted net income per diluted share

  $ 0.07     $ 0.50     $ 0.30     $ 1.02  

 

 
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Contact:

Lisa M. Wilson

President, In-Site Communications, Inc.

212-452-2793

 

 

 

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