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Press Release: Egalet Reports Third Quarter 2018 Financial ResultsFont size: A | A | A
6:05 AM ET 11/19/18 | Dow Jones
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Press Release: Egalet Reports Third Quarter 2018 Financial Results





Egalet Reports Third Quarter 2018 Financial Results

-- Highest quarterly revenue for SPRIX Nasal Spray and OXAYDO --

PR Newswire

WAYNE, Pa., Nov. 19, 2018

WAYNE, Pa., Nov. 19, 2018 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain, today reported financial results for the third quarter ended September 30, 2018 including results from commercial products: SPRIX(R) (ketorolac tromethamine) Nasal Spray and OXAYDO(R) (oxycodone HCI, USP) tablets for oral use only --CII.

"In the third quarter, we grew our commercial products and had the highest revenue for any quarter since we acquired SPRIX and licensed OXAYDO in January 2015," said Bob Radie, president and chief executive officer of Egalet. "For the remainder of the year, we are focused on continuing to grow SPRIX and OXAYDO revenues and working toward the anticipated first quarter 2019 closing of our previously-announced acquisition and financial restructuring."

2018 Third Quarter Financial Results

-- Cash Position: As of September 30, 2018, Egalet had cash, marketable

securities and restricted cash totaling $50.6 million.

-- Net Product Sales: There were net product sales of $8.2 million for the

three months ended September 30, 2018 compared to $6.7 million for the

same period in 2017. Net product sales for the three months ended

September 30, 2018 consisted of $6.1 million for SPRIX Nasal Spray, $1.9

million for OXAYDO and $174,000 for ARYMO ER. Net product sales for the

three months ended September 30, 2017 consisted of $5.0 million for SPRIX

Nasal Spray, $1.4 million for OXAYDO and $208,000 for ARYMO ER. Due to

the adoption of ASC 606 on January 1, 2018, net product sales for the

three months ended September 30, 2017 reflected prescriptions dispensed

to patients and net product sales for the three months ended September

30, 2018 reflected shipments to customers.

-- Cost of Sales (excluding product rights amortization): Cost of sales was

$1.8 million for the three months ended September 30, 2018 and $1.2

million for the same period in 2017. Cost of sales for SPRIX Nasal Spray,

OXAYDO and ARYMO ER for the three months ended September 30, 2018

reflects the average cost of inventory shipped to wholesalers and

specialty pharmaceutical companies during the period. Cost of sales for

SPRIX Nasal Spray and OXAYDO for the three months ended September 30,

2017 reflects the average cost of inventory produced and dispensed to

patients in the period. Cost of sales for ARYMO ER for the three months

ended September 30, 2017 includes the portion of inventory produced after

the FDA approval of ARYMO ER in January 2017. The portion of inventory

produced before the FDA approval of ARYMO ER was recorded in research and

development expense in prior periods.

-- G&A Expenses: General and administrative expenses were $5.6 million for

the three months ended September 30, 2018 compared to $6.8 million for

the same period in 2017. The decrease in the period was due to a decrease

in post-marketing study fees and salary expense as well as decreases in

administrative and consultant fees incurred in the three months ended

September 30, 2018.

-- S&M Expenses: Sales and marketing expenses were $7.9 million for the

three months ended September 30, 2018 compared to $8.8 million for the

same period in 2017.

-- R&D Expenses: Research and development expenses were $1.0 million for the

three months ended September 30, 2018 compared to $2.1 million for the

same period in 2017. The decrease was driven by a reduction in clinical

studies expense of $1.1 million in the three months ended September 30,

2018.

-- Restructuring and Other Charges: Restructuring and other charges of $13.9

million for the three months ended September 30, 2018 reflect costs

related to the discontinuation of ARYMO ER of $8.2 million, a charge

related to the termination payment to Halo Pharmaceuticals of $3.1

million and legal fees incurred in the three months ended September 30,

2018 related to the filing of the Chapter 11 Cases of $2.6 million.

Restructuring and other charges of $3.0 million for the three months

ended September 30, 2017 reflect costs related to Egalet's expense

reduction plan announced in August 2017 to decrease the operating

expenses that did not directly support the growth of Egalet's commercial

business.

-- Change in Fair Value of Warrant Liability and Derivative Liability:

During the three months ended September 30, 2018, Egalet recognized a

change in the fair value of its derivative liabilities of $4.0 million.

The change in fair value of the derivative liability is due primarily to

the changes in the value of Egalet's common stock during the three months

ended September 30, 2018.

-- Interest Expense: Interest expense for the three months ended September

30, 2018 was $32.9 million compared to interest expense of $4.7 million

for the same period in 2017. The increase was driven primarily by the

acceleration of the amortization of the debt discounts related to our

5.50% Notes, 6.50% Notes and 13% Notes.

-- Net Loss: Net loss for the three months ended September 30, 2018 was

($51.2 million), or ($0.93) per share, compared to a net loss of ($18.9

million), or ($0.46) per share for the same period in 2017.

Recent Announcement

On October 31, 2018, Egalet announced it had entered into an asset purchase agreement to acquire four marketed products from Iroko Pharmaceuticals, Inc. ("Iroko"). If consummated, the proposed transaction will enable Egalet to focus on marketing predominantly non-narcotic pain products. To facilitate this transaction and reorganize Egalet's capital structure, Egalet has initiated proceedings under Chapter 11 of the United States Bankruptcy Code in the District of Delaware. As part of its restructuring, Egalet has filed a plan of reorganization that is supported by a majority in dollar amount of all classes of Egalet's debt holders. Additional information on the transaction and filing is contained in a report on Form 8-K filed with the Securities and Exchange Commission.

About Egalet

Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain. Given the need for acute and chronic pain products and the issue of prescription opioid abuse, Egalet is focused on bringing non-narcotic products and abuse-discouraging formulations of opioids to patients and healthcare providers. Egalet currently promotes two approved products: SPRIX(R) (ketorolac tromethamine) Nasal Spray and OXAYDO(R) (oxycodone HCI, USP) tablets for oral use only --CII. Egalet also has a pipeline of products developed using Guardian(R) Technology which it may look to partner. The Company plans to continue to grow revenues of its commercial products, explore business development opportunities and leverage its proprietary Guardian Technology.

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 medication guide, 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 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 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 costs of Egalet's restructuring and the ability to emerge expeditiously, including there being no substantial objection to or litigation with respect to the restructuring; Egalet's ability to satisfy the requirements of its restructuring support agreement, including consummation of its proposed plan of reorganization; Egalet's expected motions to be filed in its Chapter 11 proceeding and the dispositions of such motions; Egalet's continued operations and customer and supplier relationships while in a Chapter 11 proceeding; the resources needed to support Egalet's operations while in a Chapter 11 proceeding; Egalet's ability to lower debt and interest payments, operate its business and satisfy its obligations while in a Chapter 11 proceeding; the public disclosure of sensitive business information, including projections, as part of the Chapter 11 proceedings; the anticipated benefits of the proposed Iroko acquisition and the impact of the Iroko acquisition on Egalet's earnings, capital structure, strategic plan and results of operations; the occurrence of any event, change or other circumstance that could give rise to the termination of the asset purchase agreement related to Egalet's acquisition of products from Iroko (the "Iroko Acquisition"), the failure of the closing conditions to the Iroko Acquisition to be satisfied (or any material delay in satisfying such conditions); the failure to consummate the Iroko Acquisition; the costs, fees, expenses and charges (if any) related to the Iroko Acquisition and Egalet's restructuring; Egalet's ability to continue as a going concern; the trading price of Egalet's common stock and the liquidity of the trading market with respect thereto, including the fact that

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November 19, 2018 06:02 ET (11:02 GMT)



Press Release: Egalet Reports Third Quarter 2018 -2-



Egalet's bankruptcy plan contemplated by the restructuring support agreement provides for all existing equity interests of its common stockholders to be cancelled and for its common stockholders to lose the full amount of their investment; Egalet's ability to satisfy Nasdaq initial listing requirements; Egalet's ability to recruit or retain key scientific or management personnel or to retain our executive officers; Egalet's ability to obtain and maintain regulatory approval of Egalet's or Iroko's products and the labeling claims that Egalet believes are necessary or desirable for successful commercialization of its products and product candidates; the impact of strengthening any of the labels for Egalet's products; Egalet's ability to maintain the intellectual property position of Egalet's or Iroko's products; Egalet's ability to identify and reliance upon qualified third parties to manufacture its products; Egalet's ability to commercialize its and Iroko's products, and to do so successfully; the costs of commercialization activities, including marketing, sales and distribution; 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 and Iroko's products; the impact of commercial access wins on patient access to SPRIX; the entry of any generic products for SPRIX or other products; any delay in or inability to reformulate SPRIX; Egalet's ability to find and hire qualified sales and other professionals and to retain those professionals during the pendency of Egalet's bankruptcy; the rate and degree of receptivity in the marketplace and among physicians to Egalet's and Iroko's products; the success of products that compete with Egalet's that are or become available; the regulatory environment and social concerns about limiting the use of opioids; Egalet's ability to integrate and grow any businesses or products that it may acquire; general market conditions; and other 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. 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.

Media and Investor Contact:

E. Blair Clark-Schoeb

Senior Vice President, Communications

Email: [e-mail]

Tel: [phone]

Egalet Corporation and Subsidiaries

Consolidated Balance Sheets

(in thousands, except share and per share data)

December 31, 2017 September 30, 2018

(unaudited)

Assets

Current assets:

Cash and cash equivalents $ 31,090 $ 34,248

Marketable securities,

available for sale 59,953 15,966

Accounts receivable 4,120 10,841

Inventory 3,225 3,039

Prepaid expenses and other

current assets 2,672 848

Other receivables 893 991

Total current assets 101,953 65,933

Intangible assets, net 6,583 4,816

Restricted cash 400 400

Property and equipment, net 9,911 1,158

Deposits and other assets 1,011 308

Total assets $ 119,858 $ 72,615

Liabilities and stockholders'

deficit

Current liabilities:

Accounts payable $ 10,160 $ 6,708

Accrued expenses 16,104 27,001

Deferred revenue 7,456 --

Debt - current, net 1,081 129,372

Warrant liability 8,166 --

Total current liabilities 42,967 163,081

Debt - non-current portion, net 98,890 1,221

Deferred income tax liability 26 25

Derivative liability 16,623 --

Other liabilities 727 583

Total liabilities 159,233 164,910

Stockholders' deficit:

Common stock--$0.001 par value;

75,000,000 and 275,000,000

shares authorized at December

31, 2017 and September 30,

2018, respectively; 45,939,663

and 56,772,101 shares issued

and outstanding at December

31, 2017 and September 30,

2018, respectively 46 53

Additional paid-in capital 254,871 275,680

Accumulated other comprehensive

income 1,008 912

Accumulated deficit (295,300) (368,940)

Total stockholders' deficit (39,375) (92,295)

Total liabilities and

stockholders' deficit $ 119,858 $ 72,615



Egalet Corporation and Subsidiaries

Consolidated Statements of Operations (Unaudited)

(in thousands, except share and per share data)

Three Months Ended Nine Months Ended

September 30, September 30,

2017 2018 2017 2018

Revenue

Net product sales $6,651 $8,153 $18,333 $21,857

Total revenue 6,651 8,153 18,333 21,857

Costs and Expenses

Cost of sales (excluding

amortization of product

rights) 1,249 1,773 3,646 5,553

Amortization of product

rights 528 526 1,554 1,594

General and

administrative 6,849 5,556 27,811 19,322

Sales and marketing 8,803 7,932 27,402 26,006

Research and development 2,073 956 13,187 3,258

Restructuring and other

charges 2,983 13,864 2,983 13,864

Total costs and expenses 22,485 30,607 76,583 69,597

Loss from operations (15,834) (22,454) (58,250) (47,740)

Other (income) expense:

Change in fair value of

warrant and derivative

liability (1,500) (3,986) (1,513) (12,292)

Interest expense, net 4,675 32,891 13,958 40,251

Other (gain) loss (60) (132) 106 (158)

Gain on foreign currency

exchange (1) -- (1) (1)

3,114 28,773 12,550 27,800

Loss before provision

(benefit) for income

taxes (18,948) (51,227) (70,800) (75,540)

Provision (benefit) for

income taxes -- -- -- --

Net loss $(18,948) $(51,227) $(70,800) $(75,540)

Per share information:

Net loss per share of

common stock, basic and

diluted $(0.46) $(0.93) $(2.32) $(1.45)

Weighted-average shares

outstanding, basic and

diluted 41,149,838 55,192,542 30,525,158 51,944,358



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SOURCE Egalet Corporation

/Web site: http://www.egalet.com

> Dow Jones Newswires

November 19, 2018 06:02 ET (11:02 GMT)



Egalet 3Q Rev $6.65M >EGLT





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November 19, 2018 06:04 ET (11:04 GMT)

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Egalet 3Q Loss/Shr 46c >EGLT





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November 19, 2018 06:04 ET (11:04 GMT)

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Correct: Egalet 3Q Rev $8.15M >EGLT





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November 19, 2018 06:04 ET (11:04 GMT)

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*DJ Correct: Egalet 3Q Loss/Shr 93c >EGLT





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November 19, 2018 06:05 ET (11:05 GMT)

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