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Exhibit 99.1

 

 

Egalet Reports First Quarter 2017 Financial Results

 

—Company to webcast from investor event today in New York—

 

Wayne, Penn. — May 10, 2017 — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, is hosting analysts and investors at a meeting today in New York where financial results for the first quarter ended March 31, 2017 will be reviewed.

 

Highlights from first quarter include:

 

·                  Received U.S. Food and Drug Administration (FDA) approval on January 9, 2017 of ARYMO® ER (morphine sulfate) extended-release (ER) tablets C-II 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;

·                  Internalized, expanded and deployed two teams of territory managers, one team promoting SPRIX® (ketorolac tromethamine) Nasal Spray and the other team promoting OXAYDO® (oxycodone HCI, USP) tablets for oral use only —CII and ARYMO ER, in conjunction with the launch of ARYMO ER on March 30, 2017;

·                  Grew SPRIX Nasal Spray and OXAYDO prescriptions 14 percent and added over 550 new SPRIX prescribers and almost 400 new OXAYDO prescribers from the fourth quarter of 2016 to the first quarter of 2017;

·                  Received FDA acceptance on April 18, 2017 of file for prior approval supplement for OXAYDO 10 and 15 mg dosage strengths;

·                  Closed $40 million second tranche of the $80 million senior secured debt financing previously announced on August 31, 2016; and

·                  Augmented board of directors with the addition of industry veterans, Andrea Heslin Smiley, chief executive officer of VMS BioMarketing, and Elaine Hochberg, former chief commercial officer of Forest Laboratories.

 

“The first quarter of 2017 began with the approval of ARYMO ER, the first product developed using our proprietary Guardian Technology, and ended with the deployment of the sales force to educate target health care providers on the risks and benefits of ARYMO ER,” said Bob Radie, president and chief executive officer of Egalet. “During the first quarter we saw growth continue with both SPRIX and OXAYDO and we believe our new sales force structure that was deployed at the end of the quarter should maximize the potential opportunity for all three of our products.”

 

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First Quarter 2017 Financial Results:

 

·                  Cash Position: As of March 31, 2017, Egalet had cash and marketable securities totaling $105.3 million.

·                  Net Revenue: Total net revenue was $5.4 million for the quarter ended March 31, 2017 compared to $2.7 million for the quarter ended March 31, 2016. There were net product sales of $5.4 million for the quarter ended March 31, 2017 compared to $2.6 million for the quarter ended March 31, 2016.  Collaboration revenues for the quarter ended March 31, 2016 were $100,000.

·                  Cost of Sales: Cost of sales was $1.3 million for the quarter ended March 31, 2017 and $882,000 for the quarter ended March 31, 2016.  Cost of sales for the quarter ended March 31, 2017 reflected the average cost of inventory produced and dispensed to patients and included a write down of SPRIX inventory.

·                  G&A Expenses: General and administrative expenses increased to $8.5 million for the quarter ended March 31, 2017 from $6.0 million for the same period in 2016. This was primarily attributable to increases in employee salary and benefits and increases in professional and administrative fees. In the first quarter of 2016, expenses were lower by approximately $800,000 due to a refund of a regulatory fee.

·                  S&M Expenses: Sales and marketing expenses increased to $9.3 million for the quarter ended March 31, 2017 from $6.2 million for the quarter ended March 31, 2016. This increase was primarily attributable to the expansion of our commercial organization, costs associated with the internalization of our previously contracted sales organization in January 2017 and launch preparation expenses related to ARYMO ER.

 

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·                  R&D Expenses: Research and development expenses increased to $6.5 million for the quarter ended March 31, 2017 from $6.1 million for the quarter ended March 31, 2016. The increase was driven primarily by increases in development costs for Egalet-002 and employee salary and benefits, offset by decreases in development costs for ARYMO ER and OXAYDO.

·                  Interest Expense: Interest expense increased to $4.5 million for the quarter ended March 31, 2017 from $2.3 million for the same period in 2016. The increase in interest expense for the quarter ended March 31, 2017 was primarily attributable to the 13% Senior Secured Notes, issued in August 2016 and January 2017.

·                  Net Loss: Net loss for the quarter ended March 31, 2017 was $25.4 million, or $1.02 per share, compared to a net loss of $18.5 million, or $0.76 per share, for the quarter ended March 31, 2016.

 

About Investor Day

 

Egalet is hosting an investor day in New York City with members of management and a panel of leading healthcare providers, Drs. Jeffrey Fudin, Jeffrey Goldstein and Richard Rauck. For more information about the event, please contact ir@egalet.com.  The event is by invitation only.

 

Earnings Webcast Information

 

Egalet’s management will host a live webcast to discuss the first quarter financial results today:

 

Date:              Wednesday, May 10, 2017

Time:             12:45 to 3:15 p.m. EST

Webcast:       http://egalet.investorroom.com/eventsandwebcasts.egalet.com

 

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 three approved products: ARYMO® ER (morphine sulfate) extended-release tablets for oral use only —CII, developed using Egalet’s proprietary Guardian™ Technology, OXAYDO® (oxycodone HCI, USP) tablets for oral use only —CII and SPRIX® (ketorolac tromethamine) Nasal Spray. Using Guardian Technology Egalet is developing a pipeline of clinical-stage, product candidates including Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation 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. 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 full prescribing information on ARYMO ER, including the boxed warning and medication guide, please visit arymoer.com. For full prescribing information on SPRIX, including the boxed warning and medication guide, please visit sprix.com. For full prescribing information on OXAYDO, including the boxed warning and

 

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medication guide, please visit oxaydo.com. For additional information on Egalet, please visit egalet.com.

 

Safe Harbor

 

Statements included in this press release that are not historical in nature and contain the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “look forward to” and other similar expressions are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which include expectations of maximizing the potential opportunity for our products through our deployment of our new salesforce structure, 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 its product candidates and the labeling claims that Egalet believes are necessary or desirable for successful commercialization of its products and product candidates; Egalet’s ability to maintain the intellectual property position of its products and product candidates; Egalet’s ability to identify and reliance upon qualified third parties to manufacture its products; Egalet’s ability to commercialize its products, and to do so successfully; the costs of commercialization activities, including marketing, sales and distribution; Egalet’s ability to execute on its sales and marketing strategy, including developing relationships with customers, physicians, payors and other constituencies; the size and growth potential of the markets for Egalet’s products and product candidates, and Egalet’s ability to service those markets; Egalet’s ability to obtain reimbursement and third-party payor contracts for its products; Egalet’s ability to service its debt obligations; Egalet’s ability to raise additional funds to execute its business plan and growth strategy on terms acceptable to Egalet, if at all; Egalet’s ability to find and hire qualified sales professionals; the rate and degree of 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 the Risk Factors set forth in Egalet’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in other filings Egalet makes with the SEC from time to time.  In addition, the forward-looking statements included in this press release represent Egalet’s views only as of the date hereof. Egalet anticipates that subsequent events and developments may cause its views to change. While Egalet may elect to update these forward-looking statements at some point in the future, it specifically disclaims any 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

 

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Email: bcs@egalet.com
Tel: 917-432-9275

 

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Egalet Corporation and Subsidiaries

 

Consolidated Statements of Operations (Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2016

 

2017

 

Revenues

 

 

 

 

 

Net product sales

 

$

2,563

 

$

5,427

 

Collaboration revenues

 

100

 

 

Total revenue

 

2,663

 

5,427

 

 

 

 

 

 

 

Cost and Expenses

 

 

 

 

 

Cost of sales (excluding amortization of product rights)

 

882

 

1,325

 

Amortization of product rights

 

501

 

503

 

General and administrative

 

5,998

 

8,491

 

Sales and marketing

 

6,202

 

9,258

 

Research and development

 

6,119

 

6,520

 

Total costs and expenses

 

19,702

 

26,097

 

Loss from operations

 

(17,039

)

(20,670

)

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

Change in fair value of derivative liability

 

(610

)

(12

)

Interest expense, net

 

2,309

 

4,534

 

Other gain

 

(3

)

181

 

Loss (gain) on foreign currency exchange

 

(2

)

 

 

 

1,694

 

4,703

 

Loss before provision (benefit) for income taxes

 

(18,733

)

(25,373

)

Provision (benefit) for income taxes

 

(185

)

 

Net loss

 

$

(18,548

)

$

(25,373

)

Per share information:

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(0.76

)

$

(1.02

)

Weighted-average shares outstanding, basic and diluted

 

24,406,247

 

24,766,147

 

 

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Egalet Corporation and Subsidiaries

Consolidated Balance Sheets

(in thousands, except share and per share data)

 

 

 

December 31, 2016

 

March 31, 2017

 

 

 

 

 

(unaudited)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

44,355

 

$

26,987

 

Marketable securities, available for sale

 

42,471

 

78,357

 

Accounts receivable

 

1,108

 

5,410

 

Inventory

 

1,700

 

1,511

 

Other current assets

 

 

197

 

Prepaid expenses and other current assets

 

2,537

 

1,378

 

Other receivables

 

1,001

 

1,049

 

Total current assets

 

93,172

 

114,889

 

Intangible assets, net

 

8,350

 

7,882

 

Property and equipment, net

 

12,709

 

11,857

 

Deposits and other assets

 

627

 

705

 

Total assets

 

$

114,858

 

$

135,333

 

Liabilities and stockholders’ equity (deficit)

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

2,392

 

6,598

 

Accrued expenses

 

18,147

 

15,033

 

Deferred revenue

 

3,975

 

6,175

 

Debt - current

 

381

 

428

 

Total current liabilities

 

24,895

 

28,234

 

Debt - non-current portion, net

 

83,711

 

123,380

 

Deferred income tax liability

 

23

 

23

 

Derivative liability

 

12

 

 

Other liabilities

 

891

 

849

 

Total liabilities

 

109,532

 

152,486

 

 

 

 

 

 

 

Stockholders’ equity (deficit)

 

 

 

 

 

Common stock—$0.001 par value; 75,000,000 shares authorized at December 31, 2016 and March 31, 2017; 25,189,125 and 25,407,427 shares issued and outstanding at December 31, 2016 and March 31, 2017, respectively

 

25

 

26

 

Additional paid-in capital

 

230,379

 

233,941

 

Accumulated other comprehensive (loss) income

 

100

 

194

 

Accumulated deficit

 

(225,178

)

(251,314

)

Total stockholders’ equity (deficit)

 

5,326

 

(17,153

)

Total liabilities and stockholders’ equity

 

$

114,858

 

$

135,333

 

 

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