WAYNE, Pa., Nov. 4, 2016 /PRNewswire/ -- Egalet
Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty
pharmaceutical company focused on developing, manufacturing and
commercializing innovative treatments for pain and other
conditions, today reported financial results for the third quarter
ended September 30, 2016. Egalet's
management will host a live conference call and webcast at
8:30 a.m. Eastern Time to review the
company's financial and operating results and provide a general
business update.
"Much progress was made in the third quarter with the successful
FDA Advisory Committee meeting for ARYMO ER and the closing of a
$40 million financing with a
potential additional $40 million upon
ARYMO ER approval," said Bob Radie,
president and chief executive officer of Egalet. "We are now
focused on working closely with the FDA to complete the regulatory
review of ARYMO ER and preparing for a potential launch in the
first quarter of 2017."
Third quarter highlights include:
- FDA Advisory Committee recommended approval of ARYMO ER™
(morphine sulfate) with abuse-deterrent labeling;
- Publication of ARYMO ER Category 3 oral and intranasal
abuse-deterrent data in Pain Medicine;
- Data presentations supported a strong abuse-deterrent profile
for ARYMO ER at PAINWeek;
- Category 1 abuse-deterrent study demonstrated that
OXAYDO® (oxycodone HCl, USP) tablets CII resists
syringeability, which could potentially deter abuse through the
intravenous route;
- Pharmacokinetic study demonstrated bioequivalence of OXAYDO 15
mg to Roxicodone® (oxycodone hydrochloride tablets USP)
15 mg dose;
- Completed manufacturing capacity expansion at Halo Pharma
facility;
- Appointed Patrick Shea chief
commercial officer; and
- Completed a senior secured debt offering of $40 million.
Third Quarter 2016 Financial Results:
- Cash Position: As of September
30, 2016, Egalet had cash and marketable securities totaling
$101.2 million.
- Revenue: Total net revenue was $4.7 million for the quarter ended September 30, 2016 compared to $1.7 million for the quarter ended September 30, 2015. There were net product sales
of $4.7 million for the quarter ended
September 30, 2016 compared to
$1.3 million for the quarter ended
September 30, 2015. Related party
revenues decreased from $390,000 for
the quarter ended September 30, 2015
to $0 for the quarter ended
September 30, 2016 due to the
termination of the collaboration agreement with Shionogi in the
fourth quarter of 2015.
- Cost of Sales: Cost of sales (excluding product
amortization rights) was $914,000 for
the quarter ended September 30, 2016
and $349,000 for the third quarter of
2015 related to the sales of SPRIX Nasal Spray and OXAYDO. Cost of
sales for the third quarter of 2016 consisted of both SPRIX Nasal
Spray and OXAYDO sales, while the third quarter in 2015 consisted
only of SPRIX Nasal Spray sales. Cost of sales for SPRIX Nasal
Spray reflects inventory acquired at fair value in 2015 and the
average cost of inventory subsequently produced and dispensed to
patients during the period. Cost of sales for OXAYDO reflects the
average cost of inventory dispensed to patients during the
period.
- G&A Expenses: General and administrative expenses
increased to $8.0 million for the
quarter ended September 30, 2016
compared to $5.5 million for the same
period in 2015. This was primarily attributable to increases in
employee salary, benefits and stock based compensation expenses due
to the growth of our U.S. operations. There were also increases in
professional fees which related to the FDA Advisory Committee
meeting that occurred in August
2016.
- S&M Expenses: Sales and marketing expenses increased
to $7.0 million for the quarter ended
September 30, 2016 from $6.3 million in the quarter ended September 30, 2015. Expenses for the quarter
ended September 30, 2016 consisted
primarily of salary and benefits, contract sales force and sales
and marketing for SPRIX Nasal Spray and OXAYDO and commercial
planning expenses related to ARYMO ER.
- R&D Expenses: Research and development expenses
increased to $12.1 million for the
quarter ended September 30, 2016 from
$4.6 million for the quarter ended
September 30, 2015. The increase was
driven primarily by an increase in development costs for Egalet-002
and OXAYDO.
- Interest Expense: Interest expense increased to
$3.6 million for the quarter ended
September 30, 2016 from $2.4 million for the same period in 2015. The
increase was driven primarily by $800,000 in debt extinguishment costs related to
the repayment of the Hercules loan as well as interest expense
related to the newly issued 13% Senior Secured Notes.
- Net Loss: Net loss for the quarter ended September 30, 2016 was $26.9 million, or $1.10 per share, compared to a net loss of
$17.4 million, or $0.81 per share for the quarter ended
September 30, 2015.
Conference Call Information
Egalet's management will host a conference call to discuss the
third quarter 2016 financial results:
Date:
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Friday, November 4,
2016
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Time:
|
8:30 a.m.
EDT
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|
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Webcast (live and
archive):
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egalet.com
(Events & Webcasts, Investor page)
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Dial-in
numbers:
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1-888-346-2615
(domestic)
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1-412-902-4253
(international)
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Replay
numbers:
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1-877-344-7529
(domestic)
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1-412-317-0088
(international)
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Conference
number:
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10095161
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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 two approved products: OXAYDO®
(oxycodone HCI, USP) tablets for oral use only –CII and
SPRIX® (ketorolac tromethamine) Nasal Spray. In
addition, using its proprietary Guardian™ Technology, Egalet is
developing a pipeline of clinical-stage, product candidates that
are specifically designed to deter abuse by physical and chemical
manipulation. The lead programs, ARYMO™ ER, an
abuse-deterrent, extended-release, oral morphine formulation, and
Egalet-002, an abuse-deterrent, extended-release, oral oxycodone
formulation, are being developed 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. 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. For additional information on Egalet, please visit
egalet.com. For full prescribing information on SPRIX, including
the boxed warning, please visit sprix.com. For full prescribing
information on OXAYDO, please visit oxaydo.com.
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: whether our product candidates approve regulatory
approval, our estimates regarding expenses, future revenues,
capital requirements and needs for additional financing; our
current and future indebtedness; our ability to obtain additional
financing; the level of commercial success of our products and, if
approved, our product candidates; the continued development of our
commercialization capabilities, including sales and marketing
capabilities; our ability to execute on our sales and
marketing strategy, including developing relationships with
customers, physicians, payors and other constituencies; the
difficulties in obtaining and maintaining regulatory approval of
our products and product candidates, and any related restrictions,
limitations and/or warnings in the product label under any approval
we may obtain; the success and timing of our preclinical
studies and clinical trials; the accuracy of our estimates of the
size and characteristics of the potential markets for our product
candidates and our ability to serve those markets; the rate and
degree of market acceptance of any of our product candidates; the
performance of third parties, including contract research
organizations, manufacturers and collaborators; our failure to
recruit or retain key scientific or management personnel or to
retain our executive officers; regulatory developments in the U.S.
and foreign countries; obtaining and maintaining intellectual
property protection for our product candidates and our proprietary
technology; our ability to operate our business without infringing
the intellectual property rights of others; recently enacted and
future legislation regarding the healthcare system; the success of
competing products that are or become available; and our ability to
integrate and grow any businesses or products that we may acquire;
and other risk 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
Egalet
Corporation and Subsidiaries
Consolidated
Balance Sheets
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2015
|
|
September 30, 2016
|
|
|
|
|
|
|
(unaudited)
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
46,665
|
|
$
|
46,622
|
|
Marketable securities,
available for sale
|
|
|
99,042
|
|
|
54,592
|
|
Accounts
receivable
|
|
|
295
|
|
|
3,890
|
|
Related party
receivable
|
|
|
57
|
|
|
-
|
|
Inventory
|
|
|
1,837
|
|
|
1,487
|
|
Prepaid expenses and
other current assets
|
|
|
1,295
|
|
|
1,867
|
|
Other
receivables
|
|
|
1,047
|
|
|
1,287
|
|
Total current
assets
|
|
|
150,238
|
|
|
109,745
|
|
Intangible assets,
net
|
|
|
10,380
|
|
|
8,921
|
|
Property and
equipment, net
|
|
|
7,801
|
|
|
13,584
|
|
Deposits and other
assets
|
|
|
3,997
|
|
|
1,823
|
|
Total
assets
|
|
$
|
172,416
|
|
$
|
134,073
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
7,417
|
|
|
5,713
|
|
Accrued
expenses
|
|
|
7,616
|
|
|
13,933
|
|
Deferred
revenue
|
|
|
10,128
|
|
|
4,910
|
|
Debt -
current
|
|
|
3,320
|
|
|
133
|
|
Other current
liabilities
|
|
|
183
|
|
|
500
|
|
Total current
liabilities
|
|
|
28,664
|
|
|
25,189
|
|
Debt - non-current
portion, net
|
|
|
52,442
|
|
|
82,070
|
|
Deferred income tax
liability
|
|
|
1,084
|
|
|
304
|
|
Derivative
liability
|
|
|
656
|
|
|
14
|
|
Other
liabilities
|
|
|
348
|
|
|
941
|
|
Total
liabilities
|
|
|
83,194
|
|
|
108,518
|
|
|
|
|
|
|
|
|
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Commitments and
contingencies (Note 10)
|
|
|
|
|
|
|
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Stockholders'
equity
|
|
|
|
|
|
|
|
Common stock--$0.001
par value; 75,000,000 shares authorized at
December 31, 2015 and September 30, 2016;
25,085,554 and 25,189,125 shares issued and outstanding at
December 31, 2015 and September 30, 2016,
respectively
|
|
|
25
|
|
|
25
|
|
Additional paid-in
capital
|
|
|
223,784
|
|
|
228,735
|
|
Accumulated other
comprehensive (loss) income
|
|
|
(41)
|
|
|
603
|
|
Accumulated
deficit
|
|
|
(134,546)
|
|
|
(203,808)
|
|
Total stockholders'
equity
|
|
|
89,222
|
|
|
25,555
|
|
Total liabilities and
stockholders' equity
|
|
$
|
172,416
|
|
$
|
134,073
|
|
Egalet Corporation
and Subsidiaries
Consolidated
Statements of Operations (Unaudited)
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
2015
|
|
2016
|
|
2015
|
|
2016
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
1,296
|
|
$
|
4,711
|
|
$
|
2,065
|
|
$
|
10,724
|
|
Collaboration
revenues
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
100
|
|
Related party
revenues
|
|
|
390
|
|
|
—
|
|
|
1,361
|
|
|
—
|
|
Total
revenue
|
|
|
1,686
|
|
|
4,711
|
|
|
3,426
|
|
|
10,824
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
(excluding amortization of product
rights)
|
|
|
349
|
|
|
914
|
|
|
650
|
|
|
2,580
|
|
Amortization of product
rights
|
|
|
505
|
|
|
502
|
|
|
1,468
|
|
|
1,506
|
|
General and
administrative
|
|
|
5,515
|
|
|
7,950
|
|
|
16,014
|
|
|
22,802
|
|
Sales and
marketing
|
|
|
6,283
|
|
|
6,973
|
|
|
11,142
|
|
|
19,455
|
|
Research and
development
|
|
|
4,602
|
|
|
12,070
|
|
|
19,905
|
|
|
26,886
|
|
Total costs and
expenses
|
|
|
17,254
|
|
|
28,409
|
|
|
49,179
|
|
|
73,229
|
|
Loss from
operations
|
|
|
(15,568)
|
|
|
(23,698)
|
|
|
(45,753)
|
|
|
(62,405)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of derivative liability
|
|
|
(592)
|
|
|
11
|
|
|
181
|
|
|
(642)
|
|
Interest expense,
net
|
|
|
2,380
|
|
|
3,601
|
|
|
5,146
|
|
|
8,225
|
|
Other (gain)
loss
|
|
|
—
|
|
|
(12)
|
|
|
(2)
|
|
|
54
|
|
Loss (gain) on
foreign currency exchange
|
|
|
2
|
|
|
(3)
|
|
|
87
|
|
|
—
|
|
|
|
|
1,790
|
|
|
3,597
|
|
|
5,412
|
|
|
7,637
|
|
Loss before provision
(benefit) for income taxes
|
|
|
(17,358)
|
|
|
(27,295)
|
|
|
(51,165)
|
|
|
(70,042)
|
|
Provision (benefit)
for income taxes
|
|
|
1
|
|
|
(358)
|
|
|
4
|
|
|
(780)
|
|
Net loss
|
|
$
|
(17,359)
|
|
$
|
(26,937)
|
|
$
|
(51,169)
|
|
$
|
(69,262)
|
|
Per share
information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
|
$
|
(0.81)
|
|
$
|
(1.10)
|
|
$
|
(2.81)
|
|
$
|
(2.83)
|
|
Weighted-average
shares outstanding, basic and diluted
|
|
|
21,530,153
|
|
|
24,565,554
|
|
|
18,182,781
|
|
|
24,480,494
|
|
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SOURCE Egalet Corporation