WAYNE, Pa., Nov. 8, 2017 /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 announced financial results for the third quarter
ended September 30, 2017.
"With 124% prescription growth and 41% revenue growth for our
marketed products over last year's third quarter, we continue to
grow our business," said Bob Radie,
president and chief executive officer of Egalet. "With a cash
position of $102.1 million and the
increased focus on non-narcotic and innovative treatments to
alleviate pain, we believe that we are positioned to play an
important role in what must be a multifaceted solution to address
the prescription abuse crisis."
Third quarter and recent highlights include:
- Increased SPRIX® (ketorolac tromethamine) Nasal
Spray prescriptions by 101 percent over the third quarter of 2016
and 18 percent over the second quarter of 2017, with 527 new
prescribers added;
- Partner Ascend Therapeutics began promotion of SPRIX Nasal
Spray to its approximately 11,000 target women's healthcare
providers;
- Increased prescriptions of OXAYDO® (oxycodone HCI,
USP) tablets for oral use only –CII by 71 percent over the third
quarter 2016 and seven percent over the second quarter of 2017,
with 337 prescribers added;
- More than doubled prescriptions of ARYMO® ER
(morphine sulfate) extended-release tablets for oral use —CII going
from 1,124 prescriptions in the second quarter of 2017 to 2,630
prescriptions in the third quarter;
- Garnered market access with a large payer adding ARYMO ER to
its Medicare Part D formulary; and
- Closed $30 million equity financing.
Third Quarter 2017 Financial Results:
- Cash Position: As of September
30, 2017, Egalet had cash, cash equivalents and marketable
securities totaling $102.1
million.
- Net Revenue: Total net product sales were $6.7 million for the quarter ended September 30, 2017 compared to $4.7 million for the quarter ended September 30, 2016.
- Cost of Sales: Cost of sales was $1.2 million for the quarter ended September 30, 2017 and $914,000 for the quarter ended September 30, 2016. Cost of sales for the quarter
ended September 30, 2017 reflected
the average cost of inventory produced and dispensed to
patients.
- G&A Expenses: General and administrative expenses
decreased to $6.8 million for the
quarter ended September 30, 2017 from
$8.0 million for the quarter ended
September 30, 2016. The decrease was
primarily attributable to costs incurred in the quarter ended
September 30, 2016 to prepare for the
ARYMO ER FDA Advisory Committee meeting.
- S&M Expenses: Sales and marketing expenses increased
to $8.8 million for the quarter ended
September 30, 2017 from $7.0 million for the quarter ended September 30, 2016. This increase was primarily
attributable to sales and marketing support related to ARYMO
ER.
- R&D Expenses: Research and development expenses
decreased to $2.1 million for the
quarter ended September 30, 2017 from
$12.1 million for the quarter ended
September 30, 2016. The decrease was
driven primarily by decreased costs for the development of
Egalet-002, ARYMO ER and OXAYDO.
- Interest Expense: Interest expense increased to
$4.7 million for the quarter ended
September 30, 2017 from $3.6 million for the quarter ended September 30, 2016. The increase in interest
expense for the quarter ended September 30,
2017 was primarily attributable to payments on the 13%
senior secured notes, issued in August
2016 and January 2017.
- Net Loss: Net loss for the quarter ended September 30, 2017 was $18.9 million, or $0.46 per share, compared to a net loss of
$26.9 million, or $1.10 per share, for the quarter ended
September 30, 2016.
Conference Call Information
The company will host a
live conference call and webcast at 8:30 a.m. Eastern
Time today to review the company's financial and operating
results and provide a general business update. Interested parties
may listen to the call via a live audio webcast which may be
accessed by visiting Egalet.com. Please connect to the website
a few minutes prior to the live webcast to ensure adequate time for
any software download that may be needed to access the webcast.
Individuals also may participate in the call by dialing
1-888-346-2615 (domestic) or 1-412-902-4253 (international) and
asking for the "Egalet Earnings Call." The replay will be
available approximately two hours after the call
on Egalet.com.
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 three approved products: ARYMO®
ER (morphine sulfate) extended-release tablets for oral use —CII,
developed using Egalet's proprietary Guardian™ Technology,
OXAYDO® (oxycodone HCI, USP) tablets for oral use only
—CII and SPRIX® (ketorolac tromethamine) Nasal Spray.
Using Guardian Technology, Egalet is developing a pipeline of
clinical-stage, product candidates for which we are seeking
partners including Egalet-002, an abuse-deterrent,
extended-release, oral oxycodone formulation 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. 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 full prescribing information on ARYMO ER, including
the boxed warning and medication guide, please visit arymoer.com.
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 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
successful implementation and realization of the anticipated
benefits from Egalet's expense reduction plan; Egalet's estimates
with regard to its operating plan, expenses, future revenues,
capital requirements and needs for additional financing; the
success of Egalet's clinical trials, including the timely
recruitment of trial subjects and meeting the timelines therefor;
Egalet's ability to obtain and maintain regulatory approval of its
product candidates and the labeling claims that Egalet believes are
necessary or desirable for successful commercialization of its
products and product candidates; Egalet's ability to maintain the
intellectual property position of its products and product
candidates; Egalet's ability to identify and reliance upon
qualified third parties to manufacture its products; Egalet's
ability to commercialize its products, and to do so successfully;
the costs of commercialization activities, including marketing,
sales and distribution; Egalet's ability to execute on its sales
and marketing strategy, including developing relationships with
customers, physicians, payors and other constituencies; 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 products; Egalet's ability to service or
refinance its debt obligations; Egalet's ability to raise
additional funds to execute its business plan and growth strategy
on terms acceptable to Egalet, if at all; Egalet's ability to find
and hire qualified sales professionals; the rate and degree of
receptivity in the marketplace and among physicians to Egalet's
products; the success of products which compete with Egalet's that
are or become available; general market conditions; and the 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. In addition, the
forward-looking statements included in this press release represent
Egalet's views only as of the date hereof. Egalet anticipates that
subsequent events and developments may cause its views to change.
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.
Investor and Media Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: ir@egalet.com
Tel: 484-259-7370
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,
|
|
|
|
2016
|
|
2017
|
|
2016
|
|
2017
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
4,711
|
|
$
|
6,651
|
|
$
|
10,724
|
|
$
|
18,333
|
|
Collaboration
revenues
|
|
|
—
|
|
|
—
|
|
|
100
|
|
|
—
|
|
Total
revenue
|
|
|
4,711
|
|
|
6,651
|
|
|
10,824
|
|
|
18,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
(excluding amortization of product rights)
|
|
|
914
|
|
|
1,249
|
|
|
2,580
|
|
|
3,646
|
|
Amortization of product
rights
|
|
|
502
|
|
|
528
|
|
|
1,506
|
|
|
1,554
|
|
General and
administrative
|
|
|
7,950
|
|
|
6,849
|
|
|
22,802
|
|
|
27,811
|
|
Sales and
marketing
|
|
|
6,973
|
|
|
8,803
|
|
|
19,455
|
|
|
27,402
|
|
Research and
development
|
|
|
12,070
|
|
|
2,073
|
|
|
26,886
|
|
|
13,187
|
|
Restructuring
charges
|
|
|
—
|
|
|
2,983
|
|
|
—
|
|
|
2,983
|
|
Total costs and
expenses
|
|
|
28,409
|
|
|
22,485
|
|
|
73,229
|
|
|
76,583
|
|
Loss from
operations
|
|
|
(23,698)
|
|
|
(15,834)
|
|
|
(62,405)
|
|
|
(58,250)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (income)
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of warrant and derivative liability
|
|
|
11
|
|
|
(1,500)
|
|
|
(642)
|
|
|
(1,513)
|
|
Interest expense,
net
|
|
|
3,601
|
|
|
4,675
|
|
|
8,225
|
|
|
13,958
|
|
Other (gain)
loss
|
|
|
(12)
|
|
|
(60)
|
|
|
54
|
|
|
106
|
|
Gain on foreign
currency exchange
|
|
|
(3)
|
|
|
(1)
|
|
|
—
|
|
|
(1)
|
|
|
|
|
3,597
|
|
|
3,114
|
|
|
7,637
|
|
|
12,550
|
|
Loss before provision
(benefit) for income taxes
|
|
|
(27,295)
|
|
|
(18,948)
|
|
|
(70,042)
|
|
|
(70,800)
|
|
Provision (benefit)
for income taxes
|
|
|
(358)
|
|
|
—
|
|
|
(780)
|
|
|
—
|
|
Net loss
|
|
$
|
(26,937)
|
|
$
|
(18,948)
|
|
$
|
(69,262)
|
|
$
|
(70,800)
|
|
Per share
information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
|
$
|
(1.10)
|
|
$
|
(0.46)
|
|
$
|
(2.83)
|
|
$
|
(2.32)
|
|
Weighted-average
shares outstanding, basic and diluted
|
|
|
24,565,554
|
|
|
41,149,838
|
|
|
24,480,494
|
|
|
30,525,158
|
|
Egalet Corporation
and Subsidiaries
|
|
Consolidated
Balance Sheets
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2016
|
|
September 30, 2017
|
|
|
|
|
|
|
(unaudited)
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
44,355
|
|
$
|
37,750
|
|
Marketable securities,
available for sale
|
|
|
42,471
|
|
|
64,308
|
|
Accounts
receivable
|
|
|
1,108
|
|
|
5,607
|
|
Inventory
|
|
|
1,700
|
|
|
1,835
|
|
Prepaid expenses and
other current assets
|
|
|
2,537
|
|
|
1,399
|
|
Other
receivables
|
|
|
1,001
|
|
|
1,153
|
|
Total current
assets
|
|
|
93,172
|
|
|
112,052
|
|
Intangible assets,
net
|
|
|
8,350
|
|
|
7,076
|
|
Restricted
cash
|
|
|
-
|
|
|
400
|
|
Property and
equipment, net
|
|
|
12,709
|
|
|
10,607
|
|
Deposits and other
assets
|
|
|
627
|
|
|
1,052
|
|
Total
assets
|
|
$
|
114,858
|
|
$
|
131,187
|
|
Liabilities and
stockholders' equity (deficit)
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
2,392
|
|
|
5,626
|
|
Accrued
expenses
|
|
|
18,147
|
|
|
17,972
|
|
Deferred
revenue
|
|
|
3,975
|
|
|
8,759
|
|
Debt -
current
|
|
|
381
|
|
|
547
|
|
Warrant
liability
|
|
|
-
|
|
|
8,166
|
|
Total current
liabilities
|
|
|
24,895
|
|
|
41,070
|
|
Debt - non-current
portion, net
|
|
|
83,711
|
|
|
126,161
|
|
Deferred income tax
liability
|
|
|
23
|
|
|
25
|
|
Derivative
liability
|
|
|
12
|
|
|
-
|
|
Other
liabilities
|
|
|
891
|
|
|
770
|
|
Total
liabilities
|
|
|
109,532
|
|
|
168,026
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders' equity
(deficit)
|
|
|
|
|
|
|
|
Common stock--$0.001
par value; 75,000,000 shares authorized at
December 31, 2016 and September 30, 2017;
25,189,125 and 43,029,615 shares issued and outstanding at
December 31, 2016 and September 30, 2017,
respectively
|
|
|
25
|
|
|
43
|
|
Additional paid-in
capital
|
|
|
230,379
|
|
|
258,989
|
|
Accumulated other
comprehensive income
|
|
|
100
|
|
|
868
|
|
Accumulated
deficit
|
|
|
(225,178)
|
|
|
(296,739)
|
|
Total stockholders'
equity (deficit)
|
|
|
5,326
|
|
|
(36,839)
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
|
114,858
|
|
$
|
131,187
|
|
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SOURCE Egalet Corporation