OREANDA-NEWS. Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or "the Company") today announced financial results for the three-month period ended June 30, 2016.

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

  • Total net revenue was $67.1 million, compared to $77.6 million for the second quarter of 2015;
  • Net income totaled $4.4 million, or $0.06 per basic and $0.06 per diluted share, compared to net income of $7.3 million, or $0.10 per basic and $0.10 per diluted share, for the second quarter of 2015;
  • Cash, cash equivalents and investments were $193.7 million as of June 30, 2016; and
  • Insys received FDA approval for the marketing of SyndrosTM (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol.

“We are pleased that despite the recent drop-off in volume, Subsys has maintained an approximately 44% market share. We believe that Subsys will continue to provide a very solid financial foundation for the Company, and we remain focused on restoring Subsys scripts to a growth path,” said Dr. John N. Kapoor, Chairman, President and Chief Executive Officer of Insys Therapeutics. “The recent FDA approval to market Syndros is excellent news. We are eager to expand our commercial portfolio with a product that we believe has distinct advantages over the current formulation of dronabinol in soft gel capsule and one that will provide significant long-term growth opportunities for Insys. We are proud of our pipeline and believe that product candidates in both sprays and cannabinoids hold great promise. As always, we remain committed to serving the patients who rely on our compounds, while striving to deliver value to Insys stockholders,” he concluded.

Second Quarter 2016 Financial Results

Net revenue for the second quarter of 2016 was $67.1 million compared to $77.6 million for the second quarter of 2015, a decrease of 13.5%. 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 91% for the second quarter of 2016 compared with 89% for the comparable quarter of 2015.

Sales and marketing expense was $19.7 million during the second quarter of 2016, or 29% of net revenue, compared to $22.0 million, or 28% of net revenue, for the second quarter of 2015.

Research and development expense increased to $22.9 million for the second quarter of 2016, compared to $17.8 million for the second quarter of 2015, as we continue to advance the multistage products in our pipeline.

General and administrative expense decreased to $13.9 million for the second quarter of 2016, down from $15.3 million for the second quarter of 2015.

Income tax expense was $240,000 for the second quarter of 2016, compared to $4.8 million during the second quarter of 2015.

Net income for the second quarter of 2016 was $4.4 million, or $0.06 per basic and $0.06 per diluted share, compared to net income of $7.3 million, or $0.10 per basic and $0.10 per diluted share, for the second quarter of 2015. Non-GAAP adjusted net income for the second quarter of 2016 was $9.5 million, or $0.13 per diluted share, compared to non-GAAP adjusted net income of $15.6 million, or $0.21 per diluted share, in the prior-year quarter.

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.

Non-GAAP Financial Measures

In addition to reporting all financial information required in accordance with generally accepted accounting principles (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.

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.

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 —

 
INSYS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED INCOME STATEMENTS
(In thousands, except share and per share amounts)
(unaudited)
                 
    Three Months Ended June 30,   Six Months Ended June 30,
      2016       2015       2016       2015  
Net revenue $ 67,121     $ 77,633     $ 129,083     $ 148,403  
Cost of revenue   6,273       8,305       10,911       14,680  
Gross profit   60,848       69,328       118,172       133,723  
                 
Operating expenses:              
  Sales and marketing   19,691       21,986       39,491       42,902  
  Research and development   22,889       17,796       43,424       28,398  
  General and administrative   13,924       15,284       28,622       28,530  
  Charges related to litigation award   -       2,304       -       10,304  
Total operating expenses   56,504       57,370       111,537       110,134  
                 
Income from operations   4,345       11,958       6,635       23,589  
Other income (expense),net   (5 )     30       44       30  
Interest income   256       105       481       230  
Income before income taxes   4,595       12,093       7,160       23,849  
Income tax expense   240       4,779       371       8,512  
Net income $ 4,355     $ 7,314     $ 6,789     $ 15,337  
                 
Net income per common share:              
  Basic $ 0.06     $ 0.10     $ 0.09     $ 0.22  
  Diluted $ 0.06     $ 0.10     $ 0.09     $ 0.20  
                 
Shares used in computing net income per common share:                  
  Basic   71,543,809       71,517,442       71,567,949       71,217,137  
  Diluted   74,053,550       75,478,649       74,281,838       75,255,048  
                 
                 
Percentage of Net revenue:              
                 
Net revenue   100.0 %     100.0 %     100.0 %     100.0 %
Cost of revenue   9.3 %     10.7 %     8.5 %     9.9 %
Gross profit   90.7 %     89.3 %     91.5 %     90.1 %
                 
Operating expenses:              
  Sales and marketing   29.3 %     28.3 %     30.6 %     28.9 %
  Research and development   34.1 %     22.9 %     33.6 %     19.1 %
  General and administrative   20.7 %     19.7 %     22.2 %     19.2 %
  Charges related to litigation award   0.0 %     3.0 %     0.0 %     6.9 %
Total operating expenses   84.2 %     73.9 %     86.4 %     74.2 %
                 
Income from operations   6.5 %     15.4 %     5.1 %     15.9 %
Other income (expense),net   0.0 %     0.0 %     0.0 %     0.0 %
Interest income   0.4 %     0.1 %     0.4 %     0.2 %
Income before income taxes   6.8 %     15.6 %     5.5 %     16.1 %
Income tax expense   0.4 %     6.2 %     0.3 %     5.7 %
Net income   6.5 %     9.4 %     5.3 %     10.3 %
                 
INSYS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(unaudited)
         
    June 30,   December 31,
      2016       2015  
ASSETS:      
Cash and cash equivalents $ 69,290     $ 79,515  
Short-term investments   89,081       79,576  
Accounts receivable, net   41,049       48,459  
Inventories   29,215       41,715  
Prepaid expenses and other current assets   5,359       3,973  
Long-term investments   35,339       43,219  
Other non-current assets   68,715       54,739  
Total assets $ 338,048     $ 351,196  
         
LIABILITIES AND STOCKHOLDERS' EQUITY:      
Liabilities $ 78,761     $ 97,494  
Stockholders' equity   259,287       253,702  
Total liabilities and stockholders' equity $ 338,048     $ 351,196  
         
INSYS THERAPEUTICS, INC.
RECONCILIATION OF NET INCOME TO NON-GAAP ADJUSTED EBITDA
(In thousands)
(unaudited)
                 
    Three Months Ended June 30,   Six Months Ended June 30,
      2016       2015       2016       2015  
Net income $ 4,355     $ 7,314     $ 6,789     $ 15,337  
Adjustments to arrive at EBITDA:              
  Interest (income)   (256 )     (105 )     (481 )     (230 )
  Income tax expense   240       4,779       371       8,512  
  Depreciation and amortization expense   1,496       1,282       3,023       2,457  
EBITDA   5,835       13,270       9,702       26,076  
  Non-cash stock compensation expense   4,946       4,226       10,572       7,947  
  Charges related to litigation award   -       2,304       -       10,304  
Adjusted EBITDA $ 10,781     $ 19,800     $ 20,274     $ 44,327  
                 
INSYS THERAPEUTICS, INC.
RECONCILIATION OF NET INCOME TO NON-GAAP ADJUSTED NET INCOME
(In thousands, except per share amounts)
(unaudited)
                 
    Three Months Ended June 30,   Six Months Ended June 30,
      2016       2015       2016       2015  
Net income $ 4,355     $ 7,314     $ 6,789     $ 15,337  
Income tax expense   240       4,779       371       8,512  
Income before income taxes   4,595       12,093       7,160       23,849  
Adjustments to arrive at Adjusted net income:              
  Non-cash stock compensation expense   4,946       4,226       10,572       7,947  
  Charges related to litigation award   -       2,304       -       10,304  
Adjusted income before income taxes   9,541       18,623       17,732       42,100  
  Adjusted income tax provision   -       3,032       -       3,032  
Adjusted net income $ 9,541     $ 15,591     $ 17,732     $ 39,068  
                 
Adjusted net income per diluted share $ 0.13     $ 0.21     $ 0.24     $ 0.52