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Exhibit 99.1

 

GRAPHIC

 

Egalet Reports Second Quarter 2015 Financial Results and Provides Business Update

 

—Company deployed specialty sales force, began promoting SPRIX® Nasal Spray, prepared to launch OXAYDO™ in third quarter and completed abuse-deterrent and bioequivalence studies of Guardian™ Technology product candidate Egalet-001, which will support fourth quarter new drug application (NDA) submission —

—Webcast and conference call at 8:00 AM EDT—

 

Wayne, Penn. — Aug 6, 2015 — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today reported business highlights and financial results for the three months ended June 30, 2015.

 

Second quarter and recent highlights include:

 

·                  Commercial advancements:

 

·             Launched 50-person specialty pharmaceutical sales force;

·             Began promoting SPRIX (ketorolac tromethamine) Nasal Spray to target healthcare providers; and

·             Conducted pre-launch activities, including setting up distribution system, to support a third quarter launch of OXAYDO (oxycodone HCI, USP) tablets for oral use only —CII.

 

·                  Pipeline progress:

 

·            Demonstrated bioequivalence at the 60 mg dose of abuse-deterrent, extended-release morphine, Egalet-001, to MS Contin (morphine sulfate controlled-release);

·            Met primary endpoint of reduced drug liking of Egalet-001 compared to MS Contin in intranasal human abuse liability study;

·            Announced positive top-line results from oral human abuse liability clinical study of Egalet-002, an abuse-deterrent oxycodone;

·            Demonstrated in Category 1 abuse-deterrent studies Egalet-002’s abuse-deterrent properties compared to reformulated OxyContin (oxycodone);

·            Showed in a clinical alcohol interaction study that alcohol dose dumping did not occur with Egalet-002;and

·            Announced issuance of U.S. patents covering Egalet product candidates and Guardian™ Technology.

 

·                  Corporate progress:

 

·             Completed $61.0 million offering of 5.50% Convertible Senior Notes due 2020;

·             Appointed Nicholas Nicolaides, Ph.D. and John Osborn to board of directors and appointed Timothy Walbert chairman of the board of directors; and

·             Closed $86.3 million equity follow-on offering on July 31, 2015.

 



 

“In the second quarter Egalet transitioned to a fully commercial organization, with the training and launch of our 50-person specialty sales force, promoting of SPRIX® Nasal Spray and preparing for the anticipated third quarter launch of OXAYDO” said Bob Radie, Egalet’s president and chief executive officer. “In addition, we completed the clinical and abuse-deterrent studies needed to submit the NDA for Egalet-001 in the fourth quarter of this year, which will represent a significant milestone for the company as this would be our first product fully developed using our proprietary Guardian™ Technology.”

 

Second Quarter of 2015 Financial Results

 

·                  Cash Position: Cash and marketable securities as of June 30, 2015 was $108.4 million compared to $53.9 million as of March 31, 2015. The net increase in cash and marketable securities of $54.5 million in the second quarter 2015, primarily consisted of cash inflows of $56.9 million in net proceeds from the 5.50% Convertible Senior Notes.

·                  Revenue: Net product sales of SPRIX increased from $607,000 for the three months ended June 30, 2015 from $162,000 for the three months ended March 31, 2015. Related party revenue of $352,000 for the three months ended June 30, 2015 was comprised of the amortization of the deferred revenue related to milestone payments from Shionogi and the performance of certain research and development services performed by Egalet under Egalet’s collaboration agreement with Shionogi.

·                  Costs of Sales: Cost of sales was $207,000 for the three months ended June 30, 2015 attributable entirely to sales of SPRIX which commenced in February 2015.

·                  G&A Expenses: General and administrative expenses increased to $5.8 million for the three months ended June 30, 2015 compared to $4.5 million for the same period in 2014. This increase was primarily attributable to an increase in employee compensation of $1.0 million and professional fees of $1.1 million as we continue to grow Egalet’s U.S. operations. These increases were offset by a decrease in stock compensation expense of $1.1 million.

·                  S&M Expenses: Sales and marketing expenses of $3.3 million for the three months ended June 30, 2015 were primarily related to the establishment of the commercial operations in the U.S. and launch activities for SPRIX and pre-launch activities for OXAYDO compared to minimal sales and marketing costs in the same period in 2014.

·                  R&D Expenses: Research and development expenses were $4.9 million for the three months ended June 30, 2015 compared to $7.4 million for the same period in 2014. This decrease was driven primarily by a decrease in Egalet’s development costs for Egalet-001 of $1.9 million and a decrease in stock compensation expense of $1.6 million. These decreases were offset by increases in Egalet’s development costs for Egalet-002 of $602,000 and an increase in employee compensation and professional fees of $457,000.

·                  Interest Expense: Interest expense of $2.3 million for the three months ended June 30, 2015 was primarily related to the 5.50% Convertible Senior Notes.

 



 

·                  Net Loss: Net loss increased to $17.1 million, or a loss of $1.03 per share, for the three months ended June 30, 2015 from a net loss of $11.7 million, or a loss of $0.73 per share, for the three months ended June 30, 2014.

 

Upcoming Milestones:

 

·                  Launch OXAYDO in the third quarter;

·                  Present data at PainWeek in September;

·                  Submit new drug application for Egalet-001 in the fourth quarter; and

·                  Select Egalet-003 product candidate by year end.

 

Conference Call Information

 

Egalet’s management will host a conference call to discuss the second quarter 2015 financial results:

 

Date:

Thursday, Aug 6, 2015

Time:

8:00 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:

10070056

 

About Egalet

 

Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative pain treatments. The Company has two approved products: OXAYDO (oxycodone HCI, USP) tablets for oral use only —CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using Egalet’s proprietary Guardian™ Technology, the Company is developing a pipeline of clinical-stage, opioid-based product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments 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. Full additional information on Egalet, please visit www.egalet.com.

 

Please see full prescribing information for OXAYDO at www.oxaydo.com and full prescribing information for SPRIX at www.sprix.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; ability to maintain the intellectual property position of Egalet’s products and product candidates; ability to have third parties manufacture Egalet’s products; the Company's ability to service its debt obligations; competitive factors; the Company’s ability to find and hire qualified sales professionals; the receptivity in the marketplace and among physicians to Egalet’s products; general market conditions; and other risks 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

 

Tables Follow

 



 

Egalet Corporation and Subsidiaries

 

Consolidated Balance Sheets

(in thousands, except share and per share data)

 

 

 

December 31, 2014

 

June 30, 2015

 

 

 

 

 

(unaudited)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

52,738

 

$

57,666

 

Marketable securities, available for sale

 

 

50,764

 

Related party receivable

 

679

 

537

 

Inventory

 

 

3,887

 

Other current assets

 

 

275

 

Prepaid expenses

 

698

 

378

 

Other receivables

 

1,011

 

931

 

Total current assets

 

55,126

 

114,438

 

Intangible assets, net

 

184

 

11,497

 

Property and equipment, net

 

4,417

 

4,330

 

Deposits and other assets

 

843

 

562

 

Total assets

 

$

60,570

 

$

130,827

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

4,209

 

$

3,723

 

Accrued expenses

 

2,554

 

5,504

 

Deferred revenue

 

588

 

15,108

 

Debt - current

 

 

2,616

 

License fee payable

 

 

2,500

 

Other current liabilities

 

78

 

118

 

Total current liabilities

 

7,429

 

29,569

 

Debt — non-current portion

 

 

50,758

 

Deferred income tax liability

 

25

 

27

 

Deferred revenue — non-current portion

 

8,855

 

16,703

 

Derivative liability

 

 

1,689

 

Other liabilities

 

 

120

 

Total liabilities

 

16,309

 

98,866

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock—$0.001 par value; 75,000,000 shares authorized at December 31, 2014 and June 30, 2015; 17,283,663 and 17,331,163 shares issued and outstanding at December 31, 2014 and June 30, 2015, respectively

 

17

 

17

 

Additional paid-in capital

 

121,028

 

141,964

 

Other comprehensive (loss) income

 

(171

)

401

 

Accumulated deficit

 

(76,613

)

(110,421

)

Total stockholders’ equity

 

44,261

 

31,961

 

Total liabilities and stockholders’ equity

 

$

60,570

 

$

130,827

 

 



 

Egalet Corporation and Subsidiaries

 

Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share data)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2014

 

2015

 

2014

 

2015

 

Revenues:

 

 

 

 

 

 

 

 

 

Net product sales

 

$

––

 

$

607

 

$

 

$

769

 

Related party revenues

 

490

 

352

 

746

 

973

 

Total revenues

 

490

 

959

 

746

 

1,742

 

 

 

 

 

 

 

 

 

 

 

Cost and Expenses:

 

 

 

 

 

 

 

 

 

Cost of sales (excluding amortization of product rights)

 

 

207

 

 

301

 

Amortization of product rights

 

 

585

 

 

963

 

General and administrative

 

4,516

 

5,804

 

7,778

 

10,499

 

Sales and marketing

 

212

 

3,284

 

218

 

4,859

 

Research and development

 

7,361

 

4,903

 

10,141

 

15,303

 

Total costs and expenses

 

12,089

 

14,783

 

18,137

 

31,925

 

Loss from operations

 

(11,599

)

(13,824

)

(17,391

)

(30,183

)

 

 

 

 

 

 

 

 

 

 

Other expense:

 

 

 

 

 

 

 

 

 

Change in fair value of derivative liability

 

 

773

 

 

773

 

Interest (income) expense

 

(4

)

2,306

 

7,088

 

2,766

 

Other (gain) loss

 

 

(2

)

 

(2

)

Loss on foreign currency exchange

 

47

 

188

 

43

 

85

 

 

 

43

 

3,265

 

7,131

 

3,622

 

Loss before provision for income taxes

 

(11,642

)

(17,089

)

(24,522

)

(33,805

)

Provision for income taxes

 

16

 

(23

)

51

 

3

 

Net loss

 

$

(11,658

)

$

(17,066

)

$

(24,573

)

$

(33,808

)

 

 

 

 

 

 

 

 

 

 

Per share information:

 

 

 

 

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(0.73

)

$

(1.03

)

$

(1.92

)

$

(2.05

)

Weighted-average shares outstanding, basic and diluted

 

15,887,503

 

16,506,798

 

12,780,145

 

16,481,354