Attached files

file filename
EX-31.2 - EX-31.2 - Zyla Life Sciencesa16-19131_1ex31d2.htm
EX-31.1 - EX-31.1 - Zyla Life Sciencesa16-19131_1ex31d1.htm
10-Q/A - 10-Q/A - Zyla Life Sciencesa16-19131_110qa.htm

Exhibit 99.1

 

 

Egalet Reports First Quarter 2016 Financial Results

 

—Webcast and conference call at 8:30 AM EDT—

 

WAYNE, Pa., May 10, 2016 /PRNewswire/ — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today reported financial results for the first quarter ended March 31, 2016.

 

“Highlights from the first quarter include the FDA’s acceptance of our NDA for ARYMO ER, an abuse-deterrent, extended-release morphine product candidate, and momentum building with the commercialization of our two approved products, SPRIX Nasal Spray and OXAYDO,” said Bob Radie, Egalet’s president and chief executive officer. “If approved later this year, we will be able to begin promoting ARYMO ER leveraging our commercial experience over the past 12 months having built relationships with key pain health care professional, pharmacists and payers.”

 

First Quarter 2016 Financial Results:

 

·                  Cash Position: As of March 31, 2016, Egalet had cash and marketable securities totaling $123.6 million.

·                  Revenue: Total net revenue was $2.7 million for the quarter ended March 31, 2016 compared to $805,000 for the quarter ended March 31, 2015. There were net product sales of $2.6 million for the quarter ended March 31, 2016 compared to$162,000 for the quarter ended March 31, 2015. Related party revenues decreased from $643,000 for the quarter endedMarch 31, 2015 to $0 for the quarter ended March 31, 2016 due to the termination of the collaboration agreement with Shionogi in the fourth quarter of 2015. Collaboration revenue of $100,000 for the quarter ended March 31, 2016 consisted entirely of revenue recognized under the SPRIX Nasal Spray marketing agreement with Septodont, Inc.

·                  Cost of Sales: Cost of sales was $882,000 for the quarter ended March 31, 2016 and $94,000 for the first quarter of 2015 related to the sales of SPRIX Nasal Spray and OXAYDO. The cost of sales for SPRIX Nasal Spray (excluding product amortization rights) reflects the fair value of finished

 



 

goods inventory that was acquired as part of the acquisition and was dispensed to patients during the period. The cost of sales for OXAYDO (excluding product amortization rights) reflects the average costs of inventory dispensed to patients during the period. Cost of sales for the first quarter of 2016 consisted of both SPRIX Nasal Spray and OXAYDO sales, while the first quarter in 2015 consisted only of SPRIX Nasal Spray sales.

·                  G&A Expenses: General and administrative expenses increased to $6.0 million for the quarter ended March 31, 2016compared to $4.9 million for the same period in 2015. This was primarily attributable to increases in employee salary and benefits and professional and administrative fees due to the growth of our U.S. operations. These increases were offset by a decrease in regulatory fees.

·                  S&M Expenses: Sales and marketing expenses increased to $6.2 million for the quarter ended March 31, 2016 from $1.6 million in the quarter ended March 31, 2015. Expenses for the quarter ended March 31, 2016 consisted primarily of costs related to the contract sales force, sales and marketing operations for SPRIX Nasal Spray and OXAYDO, as well as salary and benefit expenses of new sales and marketing personnel.

·                  R&D Expenses: Research and development expenses decreased to $6.1 million for the quarter ended March 31, 2016 from$10.3 million for the quarter ended March 31, 2015. The decrease was driven primarily by a decrease in ARYMO ER clinical expenses and Egalet-002 manufacturing development expenses and a decrease in stock compensation expense, partially offset by increases in salary, benefits and administrative expenses.

·                  Interest Expense: Interest expense increased to $2.3 million for the quarter ended March 31, 2016 from $451,000 for the same period in 2015. Interest expense for the quarter ended March 31, 2016 was primarily attributable to the interest expense on the 5.50% convertible notes and the Hercules loan.

·                  Net Loss: Net loss for the quarter ended March 31, 2016 was $18.5 million, or $0.76 per share, compared to a net loss of$16.7 million, or $1.02 per share, for the quarter ended March 31, 2015.

 

Conference Call Information

 

Egalet’s management will host a conference call to discuss the first quarter 2016 financial results:

 

Date:

 

Tuesday, May 10, 2016

Time:

 

8:30 a.m. EDT

Webcast (live and archive):

 

http://egalet.investorroom.com/eventsandwebcasts  

Dial-in numbers:

 

1-888-346-2615 (domestic)

 

 

1-412-902-4253 (international)

Replay numbers

 

1-877-344-7529 (domestic)

 

 

1-412-317-0088 (international)

Conference number:

 

10085537

 



 

About Egalet

 

Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has two approved products: OXAYDO® (oxycodone HCI, USP) tablets for oral use only —CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using its proprietary Guardian™ Technology, Egalet is developing a pipeline of clinical-stage, product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO™ ER, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Egalet’s Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles. For additional information on Egalet, please visit egalet.com. For full prescribing information on SPRIX, including the boxed warning, please visit sprix.com. For full prescribing information on OXAYDO, please visit oxaydo.com.

 

Safe Harbor

 

Statements included in this press release (including but not limited to upcoming milestones) that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, and are subject to known and unknown uncertainties and risks. Actual results could differ materially from those discussed due to a number of factors, including, but not limited to: the success of Egalet’s clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; Egalet’s ability to obtain regulatory approval of Egalet’s product candidates; Egalet’s ability to maintain the intellectual property position of Egalet’s products and product candidates; Egalet’s ability to identify and reliance upon qualified third parties to manufacture its products; Egalet’s ability to service its debt obligations; Egalet’s ability to find and hire qualified sales professionals; the receptivity in the marketplace and among physicians to Egalet’s products; the success of products which compete with Egalet’s that are or become available; general market conditions; and other risk factors described in Egalet’s filings with the United States Securities and Exchange Commission. Egalet assumes no obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by law.

 

Investor and Media Contact:

 

E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com 
Tel: 917-432-9275

 



 

Egalet Corporation and Subsidiaries

Consolidated Statements of Operations (Unaudited)

(in thousands, except share and per share data)

 

 

Three Months Ended

 

 

 

March 31, 

 

 

 

2015

 

2016

 

Revenues

 

 

 

 

 

Net product sales

 

$

162

 

$

2,563

 

Collaboration revenues

 

 

100

 

Related party revenues

 

643

 

 

Total revenue

 

805

 

2,663

 

Cost and Expenses

 

 

 

 

 

Cost of sales (excluding amortization of product rights)

 

94

 

882

 

Amortization of product rights

 

378

 

501

 

General and administrative

 

4,861

 

5,998

 

Sales and marketing

 

1,568

 

6,202

 

Research and development

 

10,251

 

6,119

 

Total costs and expenses

 

17,152

 

19,702

 

Loss from operations

 

(16,347

)

(17,039

)

Other (income) expense:

 

 

 

 

 

Change in fair value of derivative liability

 

 

(610

)

Interest expense, net

 

451

 

2,309

 

Other gain

 

 

(3

)

Gain on foreign currency exchange

 

(103

)

(2

)

 

 

348

 

1,694

 

Loss before provision (benefit) for income taxes

 

(16,695

)

(18,733

)

Provision (benefit) for income taxes

 

26

 

(185

)

Net loss

 

$

(16,721

)

$

(18,548

)

Per share information:

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(1.02

)

$

(0.76

)

Weighted-average shares outstanding, basic and diluted

 

16,451,669

 

24,406,247

 

 



 

Egalet Corporation and Subsidiaries

Consolidated Balance Sheets

(in thousands, except share and per share data)

 

 

 

December 31, 2015

 

March 31, 2016

 

 

 

 

 

(unaudited)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

46,665

 

$

34,167

 

Marketable securities, available for sale

 

99,042

 

89,451

 

Accounts receivable

 

295

 

829

 

Related party receivable

 

57

 

 

Inventory

 

1,837

 

2,137

 

Prepaid expenses and other current assets

 

1,295

 

1,616

 

Other receivables

 

1,047

 

2,217

 

Total current assets

 

150,238

 

130,417

 

Intangible assets, net

 

10,380

 

9,942

 

Property and equipment, net

 

7,801

 

11,310

 

Deposits and other assets

 

3,997

 

3,570

 

Total assets

 

$

172,416

 

$

155,239

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

7,417

 

5,087

 

Accrued expenses

 

7,616

 

9,573

 

Deferred revenue

 

10,128

 

8,374

 

Debt - current

 

3,320

 

5,045

 

Other current liabilities

 

183

 

251

 

Total current liabilities

 

28,664

 

28,330

 

Debt - non-current portion, net

 

52,442

 

51,959

 

Deferred income tax liability

 

1,084

 

900

 

Derivative liability

 

656

 

46

 

Other liabilities

 

348

 

1,269

 

Total liabilities

 

83,194

 

82,504

 

Commitments and contingencies (Note 10)

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Common stock—$0.001 par value; 75,000,000 shares authorized at December 31, 2015 and March 31, 2016;  25,085,554 shares issued and outstanding at December 31, 2015 and March 31, 2016, respectively

 

25

 

25

 

Additional paid-in capital

 

223,784

 

225,099

 

Accumulated other comprehensive (loss) income

 

(41

)

705

 

Accumulated deficit

 

(134,546

)

(153,094

)

Total stockholders’ equity

 

89,222

 

72,735

 

Total liabilities and stockholders’ equity

 

$

172,416

 

$

155,239