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8-K - FORM 8-K - Insys Therapeutics, Inc.insy-8k_20170331.htm

 

 

Exhibit 99.1

For Immediate Release

Insys Therapeutics Reports First Quarter 2017 Results

 

PHOENIX, Ariz. —  May 9, 2017 — Insys Therapeutics, Inc. (NASDAQ: INSY) ("Insys" or "the Company") today announced financial results for the three-month period ended March 31, 2017.

 

Highlights of and subsequent to the first quarter of 2017 include:

 

Net revenue totaled $36.0 million, compared to $60.4 million for the first quarter of 2016;

 

Net loss of $6.5 million, or $(0.09) per basic and diluted share, compared to net income of $2.3 million, or $0.03 per basic and diluted share, for the first quarter of 2016;

 

Cash, cash equivalents and investments were $218.5 million as of March 31, 2017;

 

Providing Cannabidiol Oral Solution at doses up to 40 mg/kg/day in compassionate use studies in subjects with refractory pediatric epilepsy following completion of 48 weeks of treatment in the ongoing long-term safety study;

 

Saeed Motahari became President and Chief Executive Officer and was appointed to the Board of Directors, effective April 17, 2017; and

 

Dr. Steven James joined the Company as Vice President of Medical Affairs.

 

 

“We believe we have the leading sublingual spray technology and a promising cannabinoid platform and that Insys has a significant number of exciting opportunities ahead, and I am encouraged by the progress we are making in our pipeline. Insys intends to remain committed to supporting our substantial R&D program and optimizing the performance of our current approved assets as we focus on providing much needed relief to the patients for whom our products are being developed,” said Saeed Motahari, President and Chief Executive Officer, of Insys.


 

“This year, we believe we are poised to grow our commercial portfolio from one to two products, file an NDA for buprenorphine, and significantly advance our pipeline of products across both our sublingual spray and cannabinoid platforms.  Our goal is to continue to focus on working towards a resolution in the DOJ investigation, stabilizing Subsys sales, successfully launching Syndros, and advancing our pipeline as we position ourselves for future growth,” added Motahari.

 

First Quarter 2017 Financial Results

 

Net revenue for the first quarter of 2017 was $36.0 million compared to $60.4 million for the first quarter of 2016.

 

Gross margin was 87% for the first quarter of 2017 compared with 92% for the first quarter of 2016. During the first quarter, gross margin was impacted by a $2.1 million charge for excess and obsolete Subsys inventory.

 

Sales and marketing expense was $15.7 million during the first quarter of 2017, or 44% of net revenue, compared to $19.8 million, or 33% of net revenue, for the first quarter of 2016.

 

Research and development expense decreased to $12.9 million for the first quarter of 2017, compared to $19.0 million for the first quarter of 2016.

 

General and administrative expense was $15.0 million for the first quarter of 2017, compared to $14.7 million for the first quarter of 2016.  

 

Income tax benefit was $5.3 million for the first quarter of 2017.

 

Net loss for the first quarter of 2017 was $6.5 million, or $(0.09) per basic and diluted share, compared to net income of $2.3 million, or $0.03 per basic and diluted share, for the first quarter of 2016. Non-GAAP adjusted net loss for the first quarter of 2017 was $6.8 million, or $(0.09) per diluted share, compared to non-GAAP adjusted net income of $6.5 million, or $0.09 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 $218.5 million in cash, cash equivalents, short-term and long-term investments, no debt, and $267.8 million in stockholders' equity as of March 31, 2017.

 

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Conference Call

 

As previously announced, Insys management will host its first quarter 2017 conference call as follows:

Date

 

 

 

 

 

 

 

 

 

 

 

 

Tuesday, May 9, 2017

Time

 

 

 

 

 

 

 

 

 

 

 

 

10:00 A.M. EDT

Toll free (U.S.)

 

 

 

 

 

844-263-8304

International

 

 

 

 

 

213-358-0958

Webcast (live and replay)

 

 

 

 

 

www.insysrx.com, under the “Investor Relations” section

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A 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 14339975. The webcast will be archived for 30 days at the aforementioned URL.

 

About Insys

 

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 is developing a pipeline of products intending to address unmet medical needs and the clinical shortcomings of existing commercial products. Insys currently markets one product, SUBSYS® (fentanyl sublingual spray) but has received approval for the marketing of 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 committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with high unmet need.

 

SUBSYS® and SYNDROS™ are trademarks of Insys Development Company, Inc., a subsidiary of Insys Therapeutics, Inc.

 

Forward-Looking Statements

 

This press release contains forward-looking statements including regarding our (i) believe that we have the leading sublingual spray technology and a promising cannabinoid platform, (ii) believe that Insys has a significant number of exciting opportunities ahead and remains committed to supporting our substantial R&D

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program, (iii) believe that we will grow our commercial portfolio from one to two products, file an NDA for buprenorphine, and significantly advance our pipeline of products across both our sublingual spray and cannabinoid platforms, (iv) belief that the differentiating attributes of Syndros™  will provide an important new treatment option for prescribers and patient and that Syndros™ has distinct advantages over the current formulation of dronabinol in soft gel capsule, and (v) 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, 2016 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 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 and government settlements.

 

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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 government settlements); 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.

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Contact:

Lisa M. Wilson

President, In-Site Communications, Inc.

212-452-2793

 

 

— Financial tables follow —


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INSYS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share amounts)

(unaudited)

 

 

Three Months Ended March 31,

 

 

 

2017

 

 

2016

 

Net revenue

 

$

35,962

 

 

$

60,421

 

Cost of revenue

 

 

4,639

 

 

 

4,638

 

Gross profit

 

 

31,323

 

 

 

55,783

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Sales and marketing

 

 

15,658

 

 

 

19,800

 

Research and development

 

 

12,934

 

 

 

19,035

 

General and administrative

 

 

15,042

 

 

 

14,698

 

Total operating expenses

 

 

43,634

 

 

 

53,533

 

Income (loss) from operations

 

 

(12,311

)

 

 

2,250

 

Other income (expense),net

 

 

26

 

 

 

49

 

Interest income

 

 

435

 

 

 

225

 

Income (loss) before income taxes

 

 

(11,850

)

 

 

2,524

 

Income tax expense (benefit)

 

 

(5,326

)

 

 

234

 

Net income (loss)

 

$

(6,524

)

 

$

2,290

 

 

 

 

 

 

 

 

 

 

Net income (loss) per common share:

 

 

 

 

 

 

 

 

Basic

 

$

(0.09

)

 

$

0.03

 

Diluted

 

$

(0.09

)

 

$

0.03

 

 

 

 

 

 

 

 

 

 

Shares used in computing net income per common share:

 

 

 

 

 

 

 

 

Basic

 

 

71,945,743

 

 

 

71,592,089

 

Diluted

 

 

71,945,743

 

 

 

74,462,878

 

 

 

 

 

 

 

 

 

 

Percentage of Net revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenue

 

 

100.0

%

 

 

100.0

%

Cost of revenue

 

 

12.9

%

 

 

7.7

%

Gross profit

 

 

87.1

%

 

 

92.3

%

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Sales and marketing

 

 

43.5

%

 

 

32.8

%

Research and development

 

 

36.0

%

 

 

31.5

%

General and administrative

 

 

41.8

%

 

 

24.3

%

Total operating expenses

 

 

121.3

%

 

 

88.6

%

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

 

(34.2

)%

 

 

3.7

%

Other income (expense),net

 

 

0.1

%

 

 

0.1

%

Interest income

 

 

1.2

%

 

 

0.4

%

Income (loss) before income taxes

 

 

(32.9

)%

 

 

4.2

%

Income tax expense (benefit)

 

 

(14.8

)%

 

 

0.4

%

Net income (loss)

 

 

(18.1

)%

 

 

3.8

%

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INSYS THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(unaudited)

 

 

March 31,

 

 

December 31,

 

 

 

2017

 

 

2016

 

ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

68,373

 

 

$

104,642

 

Short-term investments

 

 

86,914

 

 

 

78,238

 

Accounts receivable, net

 

 

13,313

 

 

 

20,654

 

Inventories

 

 

21,288

 

 

 

20,414

 

Prepaid expenses and other current assets

 

 

7,048

 

 

 

5,695

 

Long-term investments

 

 

63,193

 

 

 

53,796

 

Other non-current assets

 

 

77,467

 

 

 

72,697

 

Total assets

 

$

337,596

 

 

$

356,136

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY:

 

 

 

 

 

 

 

 

Liabilities

 

$

69,810

 

 

$

86,547

 

Stockholders' equity

 

 

267,786

 

 

 

269,589

 

Total liabilities and stockholders' equity

 

$

337,596

 

 

$

356,136

 

 


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INSYS THERAPEUTICS, INC.

RECONCILIATION OF NET INCOME (LOSS) TO NON-GAAP ADJUSTED EBITDA

(In thousands)

(unaudited)

 

Three Months Ended March 31,

 

 

 

2017

 

 

2016

 

Net income (loss)

 

$

(6,524

)

 

$

2,290

 

Adjustments to arrive at EBITDA:

 

 

 

 

 

 

 

 

Interest income

 

 

(435

)

 

 

(225

)

Income tax expense (benefit)

 

 

(5,326

)

 

 

234

 

Depreciation and amortization expense

 

 

1,774

 

 

 

1,527

 

EBITDA

 

 

(10,511

)

 

 

3,826

 

Non-cash stock compensation expense

 

 

3,992

 

 

 

4,126

 

Adjusted EBITDA

 

$

(6,519

)

 

$

7,952

 

 

INSYS THERAPEUTICS, INC.

RECONCILIATION OF NET INCOME (LOSS) TO NON-GAAP ADJUSTED NET INCOME (LOSS)

(In thousands, except share and per share amounts)

(unaudited)

 

Three Months Ended March 31,

 

 

 

2017

 

 

2016

 

Net income (loss)

 

$

(6,524

)

 

$

2,290

 

Income tax expense (benefit)

 

 

(5,326

)

 

 

234

 

Income (loss) before income taxes

 

 

(11,850

)

 

 

2,524

 

Adjustments to arrive at Adjusted net income (loss):

 

 

 

 

 

 

 

 

Non-cash stock compensation expense

 

 

3,992

 

 

 

4,126

 

Adjusted income (loss) before income taxes

 

 

(7,858

)

 

 

6,650

 

Less: Adjusted income tax provision

 

 

(1,095

)

 

 

128

 

Adjusted net income (loss)

 

$

(6,763

)

 

$

6,522

 

 

 

 

 

 

 

 

 

 

Adjusted net income (loss) per diluted share

 

$

(0.09

)

 

$

0.09

 

 

 

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