Corium International, Inc. (Nasdaq:CORI), a commercial-stage
biopharmaceutical company focused on the development, manufacture
and commercialization of specialty transdermal products, today
announced unaudited financial results for the third fiscal quarter
and the nine months ended June 30, 2017, and reported on
recent corporate developments. Corium's fiscal year ends
on September 30.
Recent Corporate Developments
- Initiating pivotal trial of Corplex™ Donepezil for
Alzheimer’s — Recruitment and screening of subjects for
Corium’s pivotal bioequivalence (BE) study of Corplex Donepezil is
underway, with dosing expected to begin before the end of September
2017. The pivotal BE trial is a two-way crossover study, and
will be conducted in healthy volunteers at the same clinical site
as the recently-completed pilot BE study. Topline results are
expected in the first calendar quarter of 2018, and Corium is
targeting submission of a Section 505(b)(2) New Drug Application
(NDA) in the second half of calendar 2018.
- Positive pilot bioequivalence results presented at
Alzheimer's Association International Conference® 2017 —
Corium recently presented the results from the company’s pilot BE
study of Corplex Donepezil in a poster presentation at the
Alzheimer’s Association International Conference 2017 (AAIC®) in
London. Data from the pilot BE study demonstrated that
Corium’s Corplex Donepezil transdermal product candidate
successfully met the primary pharmacokinetic criteria for
bioequivalence to oral Aricept® (donepezil hydrochloride), with a
favorable tolerability and safety profile.
- Successful follow-on financing strengthens balance
sheet — In May 2017, Corium completed an underwritten
public offering of common stock, with gross proceeds of $40.3
million, including proceeds from the full exercise of the
underwriters’ option to purchase additional shares.
- Partner Agile Therapeutics resubmits NDA for Twirla®
once-weekly contraceptive — In June 2017, Agile
Therapeutics resubmitted its NDA for Twirla, its investigational
low-dose combined hormonal contraceptive patch, and the FDA has
notified Agile of its acceptance of the resubmitted NDA for
review. Agile reported that the Prescription Drug User Fee
Act (PDUFA) goal date for this NDA is December 26, 2017.
Corium is the exclusive manufacturer and supplier of Twirla.
“Our third quarter was highlighted by the positive
bioequivalence results we reported in May for our Corplex Donepezil
transdermal product candidate,” said Peter D. Staple, President and
Chief Executive Officer of Corium. “These data have enabled
us to finalize the parameters of the pivotal BE study that we are
initiating this quarter. Our once-weekly patch formulation of
donepezil has the potential to provide meaningful benefits to
Alzheimer’s disease patients and their caregivers, including both
improved compliance and the ability to alleviate the most common
gastrointestinal side effects associated with the oral drug.”
Financial Results for the Quarter and
Nine Months Ended June 30, 2017
Corium reported total revenues in the third quarter of fiscal
2017 of $8.1 million, compared with $10.6 million in
the third quarter of fiscal 2016, and for the nine-month period
ended June 30, 2017, reported total revenues of $22.4 million
compared with $25.1 million in the same period of fiscal 2016.
Product revenues decreased for both the third quarter and the
nine-month period ended June 30, 2017 compared to same periods of
fiscal 2016, primarily as a result of a reduction in demand for
both Fentanyl transdermal delivery system (TDS) and Clonidine TDS,
which was partially offset by an increase in revenues
from manufacture of Crest® Whitestrips for Procter &
Gamble. Contract research and development revenues were
unchanged for the third quarter and increased for the nine-month
period ended June 30, 2017 compared to the same periods of fiscal
2016. The increase for the nine-month period was primarily
the result of increased activities supporting Agile’s NDA
resubmission for Twirla.
Total research and development (R&D) expenses in the third
quarter of fiscal 2017 were $12.1 million compared
with $8.3 million in the third quarter of fiscal 2016,
and for the nine-month period ended June 30, 2017, total R&D
expenses were $30.5 million compared with $24.2 million in the same
period of fiscal 2016. These increases in total R&D
expenses were driven by Corium’s investment in its proprietary
product programs, primarily the advancement of Corplex Donepezil
into a pilot BE study beginning in late fiscal 2016 and expenses
associated with the preparation for the upcoming pivotal BE
trial.
General and administrative (G&A) expenses in the third
quarter of fiscal 2017 were $3.3 million compared with $3.1
million for the third quarter of fiscal 2016, and for the
nine-month period ended June 30, 2017, total G&A expenses were
$9.3 million compared with $9.1 million for the same period of
fiscal 2016.
Corium reported a net loss for the third quarter of fiscal 2017
of $13.4 million, or $0.43 per share, compared with
a net loss of $7.5 million, or $0.34 per share, in
the third quarter of fiscal 2016. For the nine-month period
ended June 30, 2017, Corium reported a net loss of $34.9 million,
or $1.30 per share, compared with a net loss of $27.4 million, or
$1.23 per share, in the same period of fiscal 2016. As
of June 30, 2017, there were 35,739,278 shares of Corium
common stock outstanding, reflecting the issuance of 6,440,000
shares in connection with a public offering completed in May
2017.
Cash and cash equivalents as of June 30,
2017 were $66.6 million.
Conference Call and Webcast Details
Corium will host a conference call today at 5:00 p.m. ET
(2:00 p.m. PT) to discuss the financial results for the
third fiscal quarter and the nine months ended June 30,
2017. Investors and analysts can access the call toll-free by
dialing (844) 831-3024 (United States) or +1 (315) 625-6887
(international). The conference ID# is 58879021. The
conference call will also be available via a live audio webcast
which may be accessed here, or by visiting the Investors section of
Corium's website at http://ir.coriumgroup.com/events.cfm. The
webcast will be archived on the Corium website for two weeks
following the presentation.
About Corium
Corium International, Inc. is a commercial-stage
biopharmaceutical company focused on the development, manufacture
and commercialization of specialty pharmaceutical products that
leverage the company's broad experience with advanced transdermal
and transmucosal delivery systems. Corium has multiple
proprietary programs in preclinical and clinical development,
focusing primarily on the treatment of neurological disorders, with
lead programs in Alzheimer's disease. Corium has developed
and is the sole commercial manufacturer of seven prescription drug
and consumer products with partners Mayne Pharma and Procter &
Gamble. The company has two proprietary transdermal
platforms: Corplex™ for small molecules and MicroCor®, a
biodegradable microstructure technology for small molecules and
biologics, including vaccines, peptides and proteins. In
addition to its proprietary Alzheimer's program, the company's
late-stage pipeline includes a contraceptive patch co-developed
with Agile Therapeutics and additional transdermal products that
are being developed with other partners. For further
information, please visit www.coriumintl.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation
Reform Act of 1995, including statements regarding our business
strategy, financial and operating performance, operating costs and
expenses, product pipeline, clinical trial and regulatory timing
and plans and associated resource requirements, regulatory pathways
for our development programs, the achievement of clinical and
commercial milestones, and the advancement of our technologies as
well as our proprietary, co-developed and partnered products and
product candidates. Forward-looking statements are based on
management's current expectations and projections and are subject
to risks and uncertainties, which may cause Corium's actual results
to differ materially from the statements contained herein.
Further information on potential risk factors that could affect
Corium's business and its results are detailed in Corium's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2017,
filed with the Securities and Exchange Commission (SEC)
on May 12, 2017, and other reports as filed from time to time
with the SEC. Undue reliance should not be placed on
forward-looking statements, especially guidance on future financial
or operating performance, which speaks only as of the date they are
made. Corium undertakes no obligation to update publicly any
forward-looking statements to reflect new information, events or
circumstances after the date they were made or to reflect the
occurrence of unanticipated events.
Corplex™ and MicroCor® are trademarks of Corium International
Inc. Twirla® is a registered trademark of Agile Therapeutics,
Inc.Aricept® is a registered trademark of Eisai R&D Management
Co, Ltd.Crest® Whitestrips is a registered
trademark of The Procter & Gamble Company.Alzheimer’s
Association International Conference® and AAIC® are registered
trademarks of Alzheimer’s Disease and Related Disorders
Association, Inc.
Source: Corium
CORIUM INTERNATIONAL, INC. CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands,
except share and per share
data)(Unaudited) |
|
|
|
Three Months EndedJune 30, |
|
Nine Months Ended June 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenues |
|
$ |
5,906 |
|
|
$ |
7,264 |
|
|
$ |
16,301 |
|
|
$ |
18,930 |
|
|
Contract
research and development revenues |
|
|
1,936 |
|
|
|
1,983 |
|
|
|
5,320 |
|
|
|
4,228 |
|
|
Other
revenues |
|
|
267 |
|
|
|
1,359 |
|
|
|
801 |
|
|
|
1,947 |
|
|
Total
revenues |
|
|
8,109 |
|
|
|
10,606 |
|
|
|
22,422 |
|
|
|
25,105 |
|
|
Costs and operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
product revenues |
|
|
3,935 |
|
|
|
4,626 |
|
|
|
10,892 |
|
|
|
12,924 |
|
|
Cost of
contract research and development revenues |
|
|
2,977 |
|
|
|
2,742 |
|
|
|
7,891 |
|
|
|
8,601 |
|
|
Research
and development expenses |
|
|
9,122 |
|
|
|
5,516 |
|
|
|
22,650 |
|
|
|
15,566 |
|
|
General
and administrative expenses |
|
|
3,284 |
|
|
|
3,116 |
|
|
|
9,288 |
|
|
|
9,106 |
|
|
Amortization of intangible assets |
|
|
159 |
|
|
|
168 |
|
|
|
514 |
|
|
|
489 |
|
|
Loss on
disposal of equipment |
|
|
6 |
|
|
|
— |
|
|
|
6 |
|
|
|
2 |
|
|
Total
costs and operating expenses |
|
|
19,483 |
|
|
|
16,168 |
|
|
|
51,241 |
|
|
|
46,688 |
|
|
Loss from
operations |
|
|
(11,374 |
) |
|
|
(5,562 |
) |
|
|
(28,819 |
) |
|
|
(21,583 |
) |
|
Interest income |
|
|
77 |
|
|
|
54 |
|
|
|
149 |
|
|
|
142 |
|
|
Interest expense |
|
|
(2,087 |
) |
|
|
(1,984 |
) |
|
|
(6,178 |
) |
|
|
(5,932 |
) |
|
Loss before income
taxes |
|
|
(13,384 |
) |
|
|
(7,492 |
) |
|
|
(34,848 |
) |
|
|
(27,373 |
) |
|
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
2 |
|
|
|
3 |
|
|
Net loss and
comprehensive loss |
|
$ |
(13,384 |
) |
|
$ |
(7,492 |
) |
|
$ |
(34,850 |
) |
|
$ |
(27,376 |
) |
|
Net loss per share
attributable tocommon stockholders, basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.30 |
) |
|
$ |
(1.23 |
) |
|
Weighted-average shares
used incomputing net loss per share attributableto common
stockholders, basic anddiluted |
|
|
31,457,702 |
|
|
|
22,321,581 |
|
|
|
26,784,678 |
|
|
|
22,254,849 |
|
|
CORIUM
INTERNATIONAL, INC.CONDENSED BALANCE
SHEETS(In
thousands)(Unaudited) |
|
|
|
As ofJune 30, |
|
As ofSeptember 30, |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
66,563 |
|
|
$ |
39,833 |
|
|
Accounts
receivable |
|
|
4,577 |
|
|
|
4,336 |
|
|
Unbilled
accounts receivable |
|
|
260 |
|
|
|
346 |
|
|
Inventories |
|
|
2,521 |
|
|
|
2,424 |
|
|
Prepaid
expenses and other current assets |
|
|
1,133 |
|
|
|
1,341 |
|
|
Total
current assets |
|
|
75,054 |
|
|
|
48,280 |
|
|
Restricted cash |
|
|
666 |
|
|
|
666 |
|
|
Property and equipment,
net |
|
|
12,451 |
|
|
|
11,147 |
|
|
Intangible assets,
net |
|
|
7,356 |
|
|
|
7,057 |
|
|
TOTAL ASSETS |
|
$ |
95,527 |
|
|
$ |
67,150 |
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
5,404 |
|
|
$ |
2,737 |
|
|
Accrued
expenses and other current liabilities |
|
|
4,925 |
|
|
|
4,271 |
|
|
Long-term
debt, current portion |
|
|
54 |
|
|
|
77 |
|
|
Capital
lease obligations, current portion |
|
|
— |
|
|
|
72 |
|
|
Recall
liability, current portion |
|
|
160 |
|
|
|
460 |
|
|
Deferred
contract revenues, current portion |
|
|
121 |
|
|
|
355 |
|
|
Total
current liabilities |
|
|
10,664 |
|
|
|
7,972 |
|
|
Long-term debt, net of
current portion |
|
|
52,040 |
|
|
|
50,966 |
|
|
Recall liability, net
of current portion |
|
|
1,808 |
|
|
|
1,859 |
|
|
Deferred contract
revenues, net of current portion |
|
|
3,500 |
|
|
|
3,500 |
|
|
Total
liabilities |
|
|
68,012 |
|
|
|
64,297 |
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
Common
stock |
|
|
36 |
|
|
|
22 |
|
|
Additional paid-in capital |
|
|
229,817 |
|
|
|
170,319 |
|
|
Accumulated deficit |
|
|
(202,338 |
) |
|
|
(167,488 |
) |
|
Total
stockholders’ equity |
|
|
27,515 |
|
|
|
2,853 |
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
95,527 |
|
|
$ |
67,150 |
|
|
Investor and Media Contact:
SMP Communications
Susan M. Pietropaolo
susan@smpcommunications.com
(201) 923-2049
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