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Exhibit 99.1

 

 

Egalet Reports Second Quarter 2014 Financial Results and Provides Business Update

Webcast and conference call today at 8:30 a.m. EDT—

 

Wayne, Penn. — Aug 12, 2014 — Egalet Corporation (Nasdaq: EGLT) (“Egalet”) today reported business highlights and financial results for the three months ended June 30, 2014.

 

Recent highlights include:

 

·                  Appointed Jeffrey M. Dayno, M.D. as chief medical officer;

·                  Initiated Category 2/3 abuse-deterrent study of Egalet-001;

·                  Received positive results from the Category 1 abuse deterrence study which tested Egalet-001’s ability to resist a broad range of common methods of chemical and physical manipulation, including showed Egalet-001 has strong abuse-deterrent characteristics to one of the most common routes of morphine abuse, intravenous injection; and

·                  Announced top-line results from two of three bioequivalence studies for Egalet-001.

 

“Our mission is to bring medications to those living with chronic pain and offer patients and physicians peace of mind by delivering them in an abuse-deterrent formulation,” said Bob Radie, Egalet’s president and chief executive officer.  “Our top-line results from our Category 1 abuse deterrence studies demonstrated how our lead product candidate, Egalet-001, has strong abuse-deterrent characteristics, including resistance to one of the most common routes of morphine abuse, intravenous injection.”

 

2014 Financial Results

 

·                  Cash Position: Cash as of June 30, 2014 was $69.3 million compared to $77.5 million at March 31, 2014. Our primary use of capital was, and we expect will continue to be, compensation and related expenses, third-party clinical research and development services, manufacturing development and other regulatory expenses and general overhead costs. We expect our cash expenditures to increase in the near term as we fund our clinical development of Egalet-001 and Egalet-002, and continue to build-out our commercial manufacturing capability.

 

·                  Revenue: Revenues increased from zero for the three months ended June 30, 2013 to $490,000 for the three months ended June 30, 2014, as a result of the amortization of deferred revenue and the performance of certain research and development services under our collaborative agreement with Shionogi Limited.

 

·                  R&D Expenses: Research and development expenses increased to $7.4 million for the three months ended June 30, 2014 from $1.2 million for the three months ended June 30, 2013. The increase of $6.2 million was driven primarily by an increase in our development costs for Egalet-001 and Egalet-002 and employee and stock-based compensation expenses.

 



 

·                  G&A Expenses: General and administrative expenses increased to $4.7 million for the three months ended June 30, 2014 from $1.1 million for the three months ended June 30, 2013.  The increase was primarily attributable to the continued investment in our U.S. infrastructure, including the hiring of personnel, as well as the adoption of a stock compensation plan.

 

·                  Interest Expense: Interest increased to $4,000 in interest income for the three months ended June 30, 2014 from an expense of $1.4 million for the three months ended June 30, 2013. This change was primarily attributable to the conversion of our related party convertible debt upon consummation of our initial public offering in February 2014, which was outstanding during the prior year period.

 

·                  Net (Loss) Income: Net loss increased to $11.7 million for the three months ended June 30, 2014 from a net loss of $3.7 million for the three months ended June 30, 2013.

 

Upcoming Milestones

 

2014

 

·                  Q3: Complete Egalet-001 15 mg bioequivalence study

·                  Q4: Complete category 2/3 abuse-deterrent studies for Egalet-001

·                  Q4: Initiate category 2 and 3 abuse deterrence studies for Egalet-002

 

2015

 

·                  Q1: Initiate pivotal Phase 3 trials for Egalet-002

 

Conference Call Information

 

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

 

Date:

 

Tuesday, August 12, 2014

Time:

 

8:30 a.m. EDT

Webcast (live and archive):

 

http://egalet.investorroom.com/eventsandwebcasts

Dial-in numbers:

 

Replay dial-in numbers:

 

1-877-870-4263 (domestic)

1-412-317-0790 (international)

1-877-344-7529 (domestic)

1-412-317-0088 (international)

Conference Number: 10050459

 

About Egalet

 

Egalet’s mission is to help ensure access to effective medications for individuals living with chronic pain while protecting physicians, families and communities from the burden of abuse. Prescription opioid abuse has reached epidemic levels in the United States, with 6.8 million current prescription drug abusers and drug abuse is now the leading cause of accidental death in the United States. With the majority of opioids abused in the United States originating from a prescription and most often coming from a friend or family, a safeguard against the

 



 

unexpected is needed.  Egalet is committed to bringing peace of mind to the patients and physicians it serves by offering abuse-deterrent pain medications.  Using the proprietary Guardian™ Technology the Company has a pipeline of clinical-stage, opioid-based product candidates that are specifically designed to deter abuse by physical and chemical manipulation.  The Guardian Technology is customized to resist specific routes of abuse that often occur with the underlying active pharmaceutical ingredient.  The Company’s lead program, Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, is in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.  It was designed to resist common methods of abuse, including one of the most common routes for morphine via injection. With no abuse-deterrent formulations of morphine currently available, Egalet-001 which is in pivotal studies, if approved, could fill a significant unmet need in the marketplace. Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, is in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. Egalet-002 was designed to resist common methods of abuse, including crushing and snorting the most common route of abuse for oxycodone. Egalet entered into a collaboration with Shionogi in November of 2013, to develop abuse-deterrent hydrocodone based products. 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. Egalet has a strong IP position of 58 granted patents and is continually enhancing its proprietary position.  Visit www.egalet.com for more information.

 

Safe Harbor

 

Statements included in this press release 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; our ability to obtain regulatory approval of our product candidates; competitive factors; 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:

BiotechComm

E. Blair Clark-Schoeb

Tel: 917-432-9275

Email: blair@biotechcomm.com

 

Tables Follow

 



 

Egalet Corporation and Subsidiaries

 

Consolidated Statements of Operations (Unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2013

 

2014

 

2013

 

2014

 

Related party revenues

 

$

 

$

490,000

 

$

 

$

746,000

 

 

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

 

 

General and administrative

 

1,116,000

 

4,728,000

 

1,971,000

 

7,996,000

 

Research and development

 

1,200,000

 

7,361,000

 

2,163,000

 

10,141,000

 

Total operating expenses

 

2,316,000

 

12,089,000

 

4,134,000

 

18,137,000

 

Loss from operations

 

(2,316,000

)

(11,599,000

)

(4,134,000

)

(17,391,000

)

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest expense (income)

 

1,367,000

 

(4,000

)

1,367,000

 

7,088,000

 

Loss (gain) on foreign currency exchange

 

11,000

 

40,000

 

(11,000

)

43,000

 

 

 

1,378,000

 

36,000

 

1,356,000

 

7,131,000

 

Loss before provision for income taxes

 

(3,694,000

)

(11,635,000

)

(5,490,000

)

(24,522,000

)

Provision for income taxes

 

 

16,000

 

 

51,000

 

Net loss

 

$

(3,694,000

)

$

(11,651,000

)

$

(5,490,000

)

$

(24,573,000

)

 

 

 

 

 

 

 

 

 

 

Per share information:

 

 

 

 

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(2.86

)

$

(0.73

)

$

(4.25

)

$

(1.92

)

Weighted average shares outstanding, basic and diluted

 

1,292,307

 

15,887,503

 

1,292,307

 

12,780,145

 

 



 

Egalet Corporation and Subsidiaries

 

Consolidated Balance Sheets

 

 

 

December 31, 2013

 

June 30, 2014

 

 

 

 

 

(unaudited)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

15,700,000

 

$

69,259,000

 

Related party receivable

 

 

345,000

 

Prepaid expenses

 

1,774,000

 

526,000

 

Other receivables

 

231,000

 

230,000

 

Total current assets

 

17,705,000

 

70,360,000

 

Property and equipment, net

 

2,378,000

 

2,476,000

 

Intangible asset

 

209,000

 

208,000

 

Deposits and other assets

 

71,000

 

2,087,000

 

Total assets

 

$

20,363,000

 

$

75,131,000

 

Liabilities, redeemable convertible preferred stock and stockholders’ (deficit) equity

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Related party senior convertible debt, net of discount

 

$

17,209,000

 

$

 

Accounts payable

 

1,046,000

 

2,507,000

 

Accrued expenses

 

1,755,000

 

1,551,000

 

Deferred revenue

 

 

551,000

 

Other current liabilities

 

55,000

 

74,000

 

Total current liabilities

 

20,065,000

 

4,683,000

 

Deferred income tax liability

 

22,000

 

22,000

 

Deferred revenue — non-current portion

 

10,149,000

 

9,188,000

 

Total liabilities

 

30,236,000

 

13,893,000

 

 

 

 

 

 

 

Commitments and contingencies (Note 6)

 

 

 

 

 

Redeemable convertible preferred stock:

 

 

 

 

 

Redeemable convertible Series A-1 preferred stock—$0.01 par value; 1,406,894 shares and 0 shares issued and outstanding at December 31, 2013 and June 30, 2014, respectively

 

1,443,000

 

 

Redeemable convertible Series A-2 preferred stock—$0.01 par value; 593,106 shares and 0 shares issued and outstanding at December 31, 2013 and June 30, 2014, respectively

 

770,000

 

 

Redeemable convertible Series B preferred stock—$0.01 par value; 2,327,301 shares and 0 shares issued and outstanding at December 31, 2013 and June 30, 2014, respectively

 

12,628,000

 

 

Redeemable convertible Series B-1 preferred stock—$0.01 par value; 113,916 shares and 0 shares issued and outstanding at December 31, 2013 and June 30, 2014, respectively

 

116,000

 

 

Total redeemable convertible preferred stock

 

14,957,000

 

 

Stockholders’ (deficit) equity:

 

 

 

 

 

Common stock—$0.01 par value and $0.001 par value at December 31, 2013 and June 30, 2014, respectively; 75,000,000 shares authorized at June 30, 2014, 1,292,307 and 17,258,663 shares issued and outstanding at December 31, 2013 and June 30, 2014, respectively

 

13,000

 

17,000

 

Additional paid-in capital

 

7,431,000

 

118,017,000

 

Accumulated other comprehensive income

 

1,125,000

 

1,176,000

 

Accumulated deficit

 

(33,399,000

)

(57,972,000

)

Total stockholders’ (deficit) equity

 

(24,830,000

)

61,238,000

 

Total liabilities, redeemable convertible preferred stock and stockholders’ (deficit) equity

 

$

20,363,000

 

$

75,131,000