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Exhibit 99.1

 

 

Egalet Reports First Quarter 2015 Financial Results and Provides Business Update

Company accelerates SPRIX® Nasal Spray launch and commercial build out to second quarter—

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

 

Wayne, Penn. — May 7, 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 March 31, 2015.

 

First quarter and recent highlights include:

 

·                  Acquired SPRIX® (ketorolac tromethamine) Nasal Spray and in-licensed OXAYDO™ (oxycodone HCI, USP) tablets for oral use only —CII both approved by the U.S. Food and Drug Administration (FDA);

·                  To fund these transactions, Egalet entered into a $15 million debt financing with Hercules Technology Growth Capital;

·                  Appointed Deanne Melloy as chief commercial officer;

·                  Announced positive top-line results from oral human abuse liability clinical study of abuse-deterrent morphine, Egalet-001;

·                  Provided positive top-line results from 15 and 30 mg bioequivalence study of Egalet-001 compared to MS Contin;

·                  Received supportive feedback from the FDA regarding pursing a bioequivalence (BE) route of approval of Egalet-001 and thus accelerated the new drug application (NDA) filing date to fourth quarter 2015;

·                  Earned $10.0 million milestone payment triggered by the advancement of Shionogi’s product candidate, S-718632, an abuse-deterrent, extended-release hydrocodone developed using Egalet’s Guardian™ Technology;

·                  Appointed Nicholas Nicolaides, Ph.D. and John Osborn to board of directors; and

·                  Completed $60.0 million offering of convertible senior notes due 2020.

 

“The first quarter has been a transformative period for Egalet as we have evolved from a development company to a commercial organization with the acquisition of SPRIX and in-license of OXAYDO,” said Bob Radie, Egalet’s president and chief executive officer. “We have made substantial progress building our commercial capabilities and expect to launch personal promotion of SPRIX in the second quarter followed by OXAYDO in the third quarter. In addition, we have accelerated our timelines with our abuse-deterrent morphine, Egalet-001, designed using our proprietary Guardian™ Technology. Having received positive results from our 15 and 30 mg bioequivalence study combined with supportive feedback from the FDA, we plan to submit an NDA at the end of 2015 following completion of our pivotal 60 mg BE study.”

 



 

First Quarter of 2015 Financial Results

 

·                  Cash Position: Cash as of March 31, 2015 was $53.9 million compared to $52.7 million as of December 31, 2014. The net increase in cash of $1.2 million in the first quarter 2015, primarily consisted of cash inflows of $14.6 million in net proceeds from the Hercules term loan and $14.5 million in deferred revenue related to the sale of SPRIX product to our distributor, which was partially offset by cash outflows of $13.3 million for the acquisition of SPRIX and the license of OXAYDO and the net loss for the period of $16.7 million, which was offset by non-cash items of $1.9 million.

·                  Revenue: Revenues increased to $805,000 for the three months ended March 31, 2015 from $256,000 for the three months ended March 31, 2014. The increase in revenues was from our sales of SPRIX and related party revenues that consisted of the amortization of deferred revenue and certain research and development services performed under our collaboration agreement with Shionogi.

·                  Costs of Sales: Cost of sales were $94,000 for the three months ended March 31, 2015 attributable entirely to sales of SPRIX compared to no cost of sales in 2014 due to no product sales.

·                  G&A Expenses: General and administrative expenses increased to $4.9 million for the three months ended March 31, 2015 compared to $3.3 million for the same period in 2014. This increase was primarily attributable to an increase in employee compensation of $1.1 million as we continue to grow our U.S. operations and $1.0 million in fees associated with the acquisition of SPRIX. These increases were offset by a decrease in stock compensation expense of $325,000.

·                  S&M Expenses: Sales and marketing expenses were $1.6 million for the three months ended March 31, 2015 related to the establishment of the sales and marketing departments in the United States and pre-launch activities for SPRIX and OXAYDO compared to minimal sales and marketing costs in the same period in 2014.

·                  R&D Expenses: Research and development expenses were $10.3 million for the three months ended March 31, 2015 compared to $2.8 million for the same period in 2014. This increase was driven primarily by an increase in our development costs for Egalet-002 of $3.5 million, an increase in our development costs for Egalet-001 of $2.4 million and an increase in employee compensation of $243,000.

·                  Interest Expense: Interest expense decreased to $451,000 for the three months ended March 31, 2015 from $7.1 million for the same period in 2014. The decrease was primarily attributable to the $7.0 million in additional interest expense we recognized in 2014 related to the accretion of our premium that was recorded in connection with our August 2013 convertible debt issuance. Interest expense for the three months ended March 31, 2105 consisted entirely of interest on the Hercules debt financing.

·                  Net Loss: Net loss increased to $16.7 million, or a loss of $1.02 per share, for the three months ended March 31, 2015 from a net loss of $12.9 million, or a loss of $1.34 per share, for the three months ended March 31, 2014.

 

Upcoming Milestones

 

Second quarter

 

·                  Complete build out of commercial organization including 50- to 60-person sales force;

·                  Begin promoting SPRIX to target healthcare professionals;

·                  Initiate Phase 3 program for Egalet-002;

·                  Complete Category 3 oral human abuse liability study of Egalet-002;

 



 

Third quarter

 

·                  Commercial launch of OXAYDO;

·                  Announce top line results of Category 3 intranasal study of Egalet-001;

·                  Announce top line results of pivotal 60 mg bioequivalence study of Egalet-001;

 

Fourth quarter

 

·                  Initiate intranasal human abuse liability study of Egalet-002; and

·                  Submit a new drug application (NDA) filing for Egalet-001.

 

Conference Call Information

 

Egalet’s management will host a conference call to discuss the first quarter 2014 financial results:

 

Date:

Thursday, May 7, 2015

Time:

8:00 a.m. EDT

Webcast (live and archive):

http://egalet.investorroom.com/eventsandwebcasts

Dial-in numbers:

1-877-870-4263 (domestic)

 

1-412-317-0790 (international)

Replay numbers

1-877-344-7529 (domestic)

 

1-412-317-0088 (international)

Conference number:

10045494

 

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 our clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; our ability to obtain regulatory approval of our product candidates; ability to have third parties manufacture our products; competitive factors; our ability to find and hire qualified sales professionals; 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

 

March 31, 2015

 

 

 

 

 

(unaudited)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

52,738

 

$

53,887

 

Related party receivable

 

679

 

10,470

 

Inventory

 

 

2,621

 

Prepaid expenses

 

698

 

1,089

 

Other receivables

 

1,011

 

896

 

Total current assets

 

55,126

 

68,963

 

Intangible assets, net

 

184

 

9,536

 

Property and equipment, net

 

4,417

 

4,279

 

Goodwill

 

 

3,367

 

Deposits and other assets

 

843

 

693

 

Total assets

 

$

60,570

 

$

86,838

 

 

 

 

 

 

 

Liabilities and stockholders’ (deficit) equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Debt — current portion

 

$

 

$

1,294

 

Accounts payable

 

4,209

 

3,086

 

Accrued expenses

 

2,554

 

4,434

 

Deferred revenue

 

588

 

15,953

 

Due to Acura Pharmaceuticals

 

 

2,500

 

Other current liabilities

 

78

 

53

 

Total current liabilities

 

7,429

 

27,320

 

Debt — non-current portion

 

 

13,215

 

Deferred income tax liability

 

25

 

49

 

Deferred revenue — non-current portion

 

8,855

 

18,029

 

Other liabilities

 

 

57

 

Total liabilities

 

16,309

 

58,670

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock—$0.001 par value at December 31, 2014 and March 31, 2015; 75,000,000 shares authorized at December 31, 2014 and March 31, 2015; 17,283,663 and 17,323,663 shares issued and outstanding at December 31, 2014 and March 31, 2015, respectively

 

17

 

17

 

Additional paid-in capital

 

121,028

 

122,471

 

Accumulated other comprehensive loss

 

(171

)

(986

)

Accumulated deficit

 

(76,613

)

(93,334

)

Total stockholders’ equity

 

44,261

 

28,168

 

Total liabilities and stockholders’ equity

 

$

60,570

 

$

86,838

 

 



 

Egalet Corporation and Subsidiaries

 

Consolidated Statements of Operations (Unaudited)

 

(in thousands, except share and per share data)

 

 

 

Three months Ended

 

 

 

March 31,

 

 

 

2014

 

2015

 

Revenues:

 

 

 

 

 

Net Product Sales

 

$

 

$

162

 

Related party revenues

 

256

 

643

 

Total revenues

 

256

 

805

 

 

 

 

 

 

 

Cost and Expenses:

 

 

 

 

 

Cost of sales (excluding amortization of product rights)

 

 

94

 

Amortization of product rights

 

 

378

 

General and administrative

 

3,263

 

4,861

 

Sales and marketing

 

6

 

1,568

 

Research and development

 

2,780

 

10,251

 

Total costs and expenses

 

6,049

 

17,152

 

Loss from operations

 

(5,793

)

(16,347

)

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

Interest expense

 

7,092

 

451

 

Gain on foreign currency exchange

 

(4

)

(103

)

 

 

7,088

 

348

 

Loss before provision for income taxes

 

(12,881

)

(16,695

)

Provision for income taxes

 

35

 

26

 

Net loss

 

$

(12,916

)

$

(16,721

)

 

 

 

 

 

 

Per share information:

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(1.34

)

$

(1.02

)