WAYNE, Pa., Aug. 8, 2018 /PRNewswire/ -- Egalet
Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty
pharmaceutical company focused on developing, manufacturing and
marketing innovative treatments for pain and other conditions,
today reported financial results for the second quarter ended
June 30, 2018 and provided updates on
its commercial products: SPRIX® (ketorolac tromethamine)
Nasal Spray, OXAYDO® (oxycodone HCI, USP) tablets for
oral use only –CII and ARYMO® ER (morphine sulfate)
extended-release tablets for oral use —CII.
"In the second quarter, we continued to grow our commercial
products and improve our payer coverage," said Bob Radie, president and chief executive officer
of Egalet. "Since the beginning of the year, we have had five
commercial market access wins which we believe should improve
patient access to both SPRIX Nasal Spray and ARYMO ER."
Second Quarter 2018 Highlights
- Growth in net revenue for all three products and improved gross
to nets;
- National pharmacy benefit manager placed SPRIX Nasal Spray in a
preferred position and placed ARYMO ER in an unrestricted tier 3
position;
- Large Southeast regional plan placed SPRIX Nasal Spray in tier
3 covered position;
- Two large Northeast regional plans placed ARYMO ER in a
preferred formulary position; and
- Egalet appointed industry veteran John
Varian to board of directors.
2018 Second Quarter Financial Results
- Cash Position: As of June 30,
2018, Egalet had cash, marketable securities and restricted
cash totaling $70.4 million.
- Net Product Sales: There were net product sales of
$7.4 million for the three months
ended June 30, 2018 compared to
$6.3 million for the same period in
2017. Net product sales for the three months ended June 30, 2018 consisted of $5.4 million for SPRIX Nasal Spray, $1.7 million for OXAYDO and $351,000 for ARYMO ER. Net product sales for the
three months ended June 30, 2017
consisted of $4.9 million for SPRIX
Nasal Spray, $1.3 million for OXAYDO
and $31,000 for ARYMO ER. Net product
sales in the three months ended June 30,
2017 reflected prescriptions dispensed to patients. Due to
the adoption of the ASC 606 on January 1,
2018, net product sales in the three months ended
June 30, 2018 reflected shipments to
customers.
- Cost of Sales (excluding product rights
amortization): Cost of sales was $1.6
million for the three months ended June 30, 2018 and $1.1
million for the same period in 2017. Cost of sales for SPRIX
Nasal Spray, OXAYDO and ARYMO ER for the three months ended
June 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 June 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 June 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 $6.7 million for the three
months ended June 30, 2018 compared
to $12.5 million for the same period
in 2017. The decrease in the period is due to $4.5 million related to ARYMO ER post-marketing
study fees incurred in the three months ended June 30, 2017 and a decrease in salary and
stock-based compensation expense of $1.1
million for the three months ended June 30, 2018 due to reduced headcount.
- S&M Expenses: Sales and marketing expenses were
$9.0 million for the three months
ended June 30, 2018 compared to
$9.3 million for the same period in
2017.
- R&D Expenses: Research and development expenses were
$1.0 million for the three months
ended June 30, 2018 compared to
$4.6 million for the same period in
2017. The decrease in the period was driven primarily by a decrease
in compensation-related expenses of $1.1
million and a decrease in development costs for Egalet-002
of $3.1 million in the three months
ended June 30, 2018.
- Change in Fair Value of Warrant Liability and Derivative
Liability: During the three months ended June 30, 2018, Egalet recognized a change in the
fair value of its derivative liabilities of $3.2 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 June 30, 2018.
- Interest Expense: Interest expense for the three months
ended June 30, 2018 was $3.8 million compared to interest expense of
$4.7 million for the same period in
2017. The decrease was driven primarily by the decrease in interest
expense of $1.2 million related to
the extinguishment of $36.4 million
of the 5.50% Notes in December 2017,
offset by an increase of $451,000
related to the issuance of $23.9
million of 6.50% Notes. The interest expense of $3.8 million for the three months ended
June 30, 2018 includes non-cash
interest and amortization of debt discount totaling $697,000. The interest expense of $4.7 million for the three months ended
June 30, 2017 includes non-cash
interest and amortization of debt discount totaling $1.6 million.
- Net Loss: Net loss for the three months ended
June 30, 2018 was ($12.0 million), or ($0.22) per share, compared to a net loss of
($26.5 million), or ($1.04) per share for the same period in
2017.
Earnings Conference Call Information
Egalet's
management will host a conference call to discuss the second
quarter 2018 financial results today:
Date:
|
Wednesday, August 8,
2018
|
Time:
|
8:30 a.m.
EDT
|
Webcast (live and
archive):
|
egalet.com
(Events & Webcasts, Investor page)
|
Dial-in
numbers:
|
1-888-346-2615
(domestic)
|
|
1-412-902-4253
(international)
|
Replay
numbers:
|
1-877-344-7529
(domestic)
|
|
1-412-317-0088
(international)
|
Conference
number:
|
10122708
|
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 developed 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
(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: Egalet's
ability to continue as a going concern; Egalet's stock price and
ability to remain listed on the Nasdaq, including Egalet's ability
to meet the conditions and milestones established by the Nasdaq
Hearings Panel and the potential need to redeem portions of its
remaining outstanding indebtedness in the event of such a
delisting; the amount and potential impact of any redemption
of Egalet's 5.50% Convertible Senior Notes due 2020; the potential
need to seek bankruptcy protection, whether in connection with the
potential obligation to redeem portions of our outstanding
indebtedness, our failure to so redeem or in connection with any
defaults under our outstanding indebtedness or otherwise; the
reception by healthcare professionals of any new formulation of
SPRIX and the timing of availability of any new SPRIX formulation;
the potential impact of strengthening the ARYMO ER label or the
labels of any of Egalet's other products; 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 Egalet's products and 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 Egalet's 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; 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; the
impact of commercial access wins on patient access to SPRIX Nasal
Spray and ARYMO ER; Egalet's ability to service 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; the entry of any generic products for SPRIX or
any delay in or inability to reformulate SPRIX; 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 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: ir@egalet.com
Tel: 484-259-7370
Egalet Corporation
and Subsidiaries
Consolidated
Balance Sheets
(in thousands,
except share and per share data)
|
|
|
|
December 31, 2017
|
|
June 30,
2018
|
|
|
|
|
|
(unaudited)
|
Assets
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
31,090
|
|
$
|
37,829
|
Marketable securities,
available for sale
|
|
|
59,953
|
|
|
32,178
|
Accounts
receivable
|
|
|
4,120
|
|
|
9,083
|
Inventory
|
|
|
3,225
|
|
|
3,183
|
Prepaid expenses and
other current assets
|
|
|
2,672
|
|
|
1,539
|
Other
receivables
|
|
|
893
|
|
|
889
|
Total current
assets
|
|
|
101,953
|
|
|
84,701
|
Intangible assets,
net
|
|
|
6,583
|
|
|
5,466
|
Restricted
cash
|
|
|
400
|
|
|
400
|
Property and
equipment, net
|
|
|
9,911
|
|
|
8,565
|
Deposits and other
assets
|
|
|
1,011
|
|
|
848
|
Total
assets
|
|
$
|
119,858
|
|
$
|
99,980
|
Liabilities and
stockholders' deficit
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
10,160
|
|
$
|
8,758
|
Accrued
expenses
|
|
|
16,104
|
|
|
27,949
|
Deferred
revenue
|
|
|
7,456
|
|
|
—
|
Debt - current,
net
|
|
|
1,081
|
|
|
22,386
|
Warrant
liability
|
|
|
8,166
|
|
|
2,833
|
Total current
liabilities
|
|
|
42,967
|
|
|
61,926
|
Debt - non-current
portion, net
|
|
|
98,890
|
|
|
78,620
|
Deferred income tax
liability
|
|
|
26
|
|
|
1,005
|
Derivative
liability
|
|
|
16,623
|
|
|
1,153
|
Other
liabilities
|
|
|
727
|
|
|
634
|
Total
liabilities
|
|
|
159,233
|
|
|
143,338
|
|
|
|
|
|
|
|
Stockholders'
deficit
|
|
|
|
|
|
|
Common stock--$0.001
par value; 75,000,000 and 275,000,000 shares authorized at December
31, 2017 and June 30, 2018, respectively; 45,939,663 and 56,298,373
shares issued and outstanding at December 31, 2017 and June 30,
2018, respectively
|
|
|
46
|
|
|
52
|
Additional paid-in
capital
|
|
|
254,871
|
|
|
273,379
|
Accumulated other
comprehensive income
|
|
|
1,008
|
|
|
926
|
Accumulated
deficit
|
|
|
(295,300)
|
|
|
(317,715)
|
Total stockholders'
deficit
|
|
|
(39,375)
|
|
|
(43,358)
|
Total liabilities and
stockholders' deficit
|
|
$
|
119,858
|
|
$
|
99,980
|
Consolidated
Statements of Operations (Unaudited)
(in thousands,
except share and per share data)
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
June 30,
|
|
June 30,
|
|
|
2017
|
|
2018
|
|
2017
|
|
2018
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
6,255
|
|
$
|
7,443
|
|
$
|
11,682
|
|
$
|
13,704
|
Total
revenue
|
|
|
6,255
|
|
|
7,443
|
|
|
11,682
|
|
|
13,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
(excluding amortization of product rights)
|
|
|
1,072
|
|
|
1,565
|
|
|
2,397
|
|
|
3,780
|
Amortization of
product rights
|
|
|
522
|
|
|
531
|
|
|
1,025
|
|
|
1,068
|
General and
administrative
|
|
|
12,471
|
|
|
6,695
|
|
|
20,962
|
|
|
13,767
|
Sales and
marketing
|
|
|
9,340
|
|
|
9,019
|
|
|
18,598
|
|
|
18,074
|
Research and
development
|
|
|
4,594
|
|
|
999
|
|
|
11,114
|
|
|
2,302
|
Total costs and
expenses
|
|
|
27,999
|
|
|
18,809
|
|
|
54,096
|
|
|
38,991
|
Loss from
operations
|
|
|
(21,744)
|
|
|
(11,365)
|
|
|
(42,414)
|
|
|
(25,287)
|
Other (income)
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of warrant and derivative liability
|
|
|
—
|
|
|
(3,181)
|
|
|
(12)
|
|
|
(8,306)
|
Interest expense,
net
|
|
|
4,749
|
|
|
3,804
|
|
|
9,283
|
|
|
7,360
|
Other (gain)
loss
|
|
|
(14)
|
|
|
(25)
|
|
|
167
|
|
|
(25)
|
|
|
|
4,735
|
|
|
598
|
|
|
9,438
|
|
|
(971)
|
Loss before provision
(benefit) for income taxes
|
|
|
(26,479)
|
|
|
(11,963)
|
|
|
(51,852)
|
|
|
(24,316)
|
Provision (benefit)
for income taxes
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
Net loss
|
|
$
|
(26,479)
|
|
$
|
(11,963)
|
|
$
|
(51,852)
|
|
$
|
(24,316)
|
Per share
information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
|
$
|
(1.04)
|
|
$
|
(0.22)
|
|
$
|
(2.06)
|
|
$
|
(0.48)
|
Weighted-average
shares outstanding, basic and diluted
|
|
|
25,542,733
|
|
|
53,302,399
|
|
|
25,145,440
|
|
|
50,302,419
|
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SOURCE Egalet Corporation