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, 2016, and reported on recent corporate developments.
Corium's fiscal year ends on September 30.
“In our third quarter, we made important advances in executing
on our business strategy. We achieved key milestones in our
Corium-owned Alzheimer’s transdermal product development programs,
which represent transformational growth opportunities,” commented
Peter D. Staple, President and Chief Executive Officer of
Corium. “We also had a strong financial performance in the
quarter. Revenues were up sharply and we used significantly
less cash during the quarter than we have in the preceding two
quarters. In addition, we continue to carefully manage
resources, including the recent realignment of the organization, to
focus on our highest value development programs.”
Corium’s Chief Technology Officer Parminder “Bobby” Singh, Ph.D.
added, “We were very pleased to receive favorable feedback from the
FDA on a streamlined bioequivalence pathway for development of our
Corplex Donepezil once-weekly Alzheimer’s patch candidate, and we
anticipate initiating the pilot bioequivalence study in the fourth
calendar quarter of 2016. We also expect feedback from the
FDA in the coming weeks on whether our Corplex Memantine program
will benefit from the same regulatory pathway.”
Recent Corporate Developments
- Third quarter revenues up 52% from second quarter
— Quarterly revenues returned to levels last achieved
in the third quarter of 2015 as the disruption caused by the
extended FTC review of Teva’s acquisition of Allergan’s generic
business, and its impact on our Clonidine TDS product, moved toward
resolution.
- FDA provides favorable guidance on lead Alzheimer’s
program — The company reported on May 2 that it had
received written pre-IND feedback from the FDA that concurred with
the company’s proposed bioequivalence-based clinical development
plan for its Corplex Donepezil candidate. Consistent with its
handling of Corium’s submission for Corplex Donepezil, the FDA has
advised that a written response to the request for pre-IND guidance
on Corplex Memantine will be provided during the quarter ending
September 30.
- Preclinical study of optimized once-weekly Corplex
Memantine confirms achievement of target dosing — An
optimized formulation has successfully delivered the required dose
of memantine over seven days in a pig study, with acceptable skin
tolerability. Corium plans to conduct a pharmacokinetic study
of the optimized formulation in healthy subjects to confirm
sustained delivery over one week.
- Positive Corplex Donepezil results presented at the
2016 Alzheimer’s Association International Conference (AAIC) in
Toronto, Canada — Dr. Singh presented a poster on the
full results from a recent Phase 1 clinical trial of once-weekly
Corplex Donepezil, Corium’s lead candidate for the treatment of
Alzheimer’s disease.
Financial Results for the Quarter and Nine Months
Ended June 30, 2016
Corium reported total revenues in the third quarter of fiscal
2016 of $10.6 million, compared with $10.6
million in the third quarter of fiscal 2015, and for the
nine-month period ended June 30, 2016, reported total
revenues of $25.1 million, compared with $31.7
million in the same period of fiscal 2015. For the
nine-month period, the decrease in total revenues resulted
primarily from a decline in contract research and development
revenues, as well as a decline in product revenues versus the same
period in fiscal 2015. The decrease in contract research and
development revenues is primarily the result of several programs
advancing into later stages of clinical development, when there are
fewer revenue-generating development activities until preparations
begin for approval and commercial launch, along with the
discontinuation of two development projects in fiscal 2015.
The decline in product revenues for the nine-month period in 2016
compared to the same period in 2015 is primarily the result of the
lower level of Fentanyl TDS units ordered and shipped, which was
partially offset by a slight increase in revenues
from Crest® Whitestrips. Total research and
development (R&D) expenses in the third quarter of fiscal 2016
were $8.3 million, compared with $7.6 million in the
third quarter of fiscal 2015, and for the nine-month period
ended June 30, 2016, total R&D expenses
were $24.2 million, compared with $24.0 million in
the same period of fiscal 2015. The increase in total R&D
expenses primarily reflects Corium's increased investment in its
proprietary product programs, including the advancement of Corium's
two programs for Alzheimer's disease through Phase 1 clinical
trials. This increase was partially offset by the lower level
of resources required for contract research and development
programs, which corresponds to the lower level of revenues from
contract research and development.
General and administrative (G&A) expenses in the third
quarter of fiscal 2016 were $3.1 million, compared
with $2.8 million in the third quarter of fiscal 2015,
and for the nine-month period ended June 30,
2016, G&A expenses were $9.1 million, compared
with $8.2 million in the same period of fiscal 2015.
The increase in G&A for the 9-month period was primarily
attributable to higher personnel costs along with an increase in
stock-based compensation expense.
Corium reported a net loss for the third quarter of fiscal 2016
of $7.5 million, or $0.34 per share, compared with a
net loss of $5.9 million, or $0.33 per share, in the
third quarter of fiscal 2015. For the nine-month period
ended June 30, 2016 Corium reported a net loss
of $27.4 million, or $1.23 per share, compared with
a net loss of $19.8 million, or $1.10 per share, in
the same period of fiscal 2015. As of June 30, 2016,
there were 22,359,011 shares of Corium common stock
outstanding.
Cash and cash equivalents as of June 30,
2016 were $47.4 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 nine months ended June 30,
2016. 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 56382169. The
conference call will also be available via a live audio webcast on
the Investors section of Corium's website
at http://ir.coriumgroup.com/events.cfm. Please access the
website 10 minutes prior to the start of the call to ensure
adequate time for any software downloads that may be
necessary. A replay of the conference call will be available
for two weeks and may be accessed by visiting Corium's website.
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 Teva Pharmaceuticals, Endo
Pharmaceuticals 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. The company's late-stage pipeline includes a
contraceptive patch co-developed with Agile Therapeutics that is
currently in Phase 3 trials, and additional transdermal products
that are being developed with other partners. For further
information, please visit www.coriumgroup.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,
2016, filed with the Securities and Exchange
Commission on May 13, 2016, and other reports as filed
from time to time with the Securities and Exchange
Commission. 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 registered trademarks
of Corium International, Inc.
Crest® Whitestrips is a registered trademark of The
Procter & Gamble Company.
CORIUM
INTERNATIONAL, INC. |
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
(in
thousands, except share and per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Nine Months Ended June 30, |
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
|
7,264 |
|
|
$ |
|
6,296 |
|
|
$ |
|
18,930 |
|
|
$ |
|
20,467 |
|
|
Contract research and development
revenues |
|
|
|
1,983 |
|
|
|
|
3,505 |
|
|
|
|
4,228 |
|
|
|
|
9,798 |
|
|
Other revenues |
|
|
|
1,359 |
|
|
|
|
797 |
|
|
|
|
1,947 |
|
|
|
|
1,390 |
|
|
Total revenues |
|
|
|
10,606 |
|
|
|
|
10,598 |
|
|
|
|
25,105 |
|
|
|
|
31,655 |
|
|
Costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
|
|
4,626 |
|
|
|
|
4,063 |
|
|
|
|
12,924 |
|
|
|
|
13,369 |
|
|
Cost of contract research and
development revenues |
|
|
|
2,742 |
|
|
|
|
4,065 |
|
|
|
|
8,601 |
|
|
|
|
12,292 |
|
|
Research and development
expenses |
|
|
|
5,516 |
|
|
|
|
3,493 |
|
|
|
|
15,566 |
|
|
|
|
11,670 |
|
|
General and administrative
expenses |
|
|
|
3,116 |
|
|
|
|
2,835 |
|
|
|
|
9,106 |
|
|
|
|
8,192 |
|
|
Amortization of intangible
assets |
|
|
|
168 |
|
|
|
|
141 |
|
|
|
|
489 |
|
|
|
|
464 |
|
|
(Gain) / loss on disposal of
equipment |
|
|
|
— |
|
|
|
|
(5 |
) |
|
|
|
2 |
|
|
|
|
2 |
|
|
Total costs and operating
expenses |
|
|
|
16,168 |
|
|
|
|
14,592 |
|
|
|
|
46,688 |
|
|
|
|
45,989 |
|
|
Loss from operations |
|
|
|
(5,562 |
) |
|
|
|
(3,994 |
) |
|
|
|
(21,583 |
) |
|
|
|
(14,334 |
) |
|
Interest income |
|
|
|
54 |
|
|
|
|
5 |
|
|
|
|
142 |
|
|
|
|
11 |
|
|
Interest expense |
|
|
|
(1,984 |
) |
|
|
|
(1,925 |
) |
|
|
|
(5,932 |
) |
|
|
|
(5,490 |
) |
|
Loss before income taxes |
|
|
|
(7,492 |
) |
|
|
|
(5,914 |
) |
|
|
|
(27,373 |
) |
|
|
|
(19,813 |
) |
|
Income tax expense |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
3 |
|
|
|
|
2 |
|
|
Net loss and comprehensive loss |
|
$ |
|
(7,492 |
) |
|
$ |
|
(5,914 |
) |
|
$ |
|
(27,376 |
) |
|
$ |
|
(19,815 |
) |
|
Net loss per share attributable to common
stockholders, basic and diluted |
|
$ |
|
(0.34 |
) |
|
$ |
|
(0.33 |
) |
|
$ |
|
(1.23 |
) |
|
$ |
|
(1.10 |
) |
|
Weighted average shares used in computing net
loss per share attributable to common stockholders, basic and
diluted |
|
|
|
22,321,581 |
|
|
|
|
18,116,021 |
|
|
|
|
22,254,849 |
|
|
|
|
18,073,879 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORIUM
INTERNATIONAL, INC. |
CONDENSED
BALANCE SHEETS |
(in
thousands, except share amounts) |
(Unaudited) |
|
|
|
As of June 30,
2016 |
|
As of September 30,
2015 |
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
|
47,394 |
|
|
$ |
|
72,218 |
|
|
Accounts receivable |
|
|
|
4,091 |
|
|
|
|
4,461 |
|
|
Unbilled accounts receivable |
|
|
|
517 |
|
|
|
|
812 |
|
|
Inventories, net |
|
|
|
2,830 |
|
|
|
|
2,902 |
|
|
Prepaid expenses and other current
assets |
|
|
|
1,459 |
|
|
|
|
1,367 |
|
|
Total current assets |
|
|
|
56,291 |
|
|
|
|
81,760 |
|
|
Restricted cash |
|
|
|
666 |
|
|
|
|
— |
|
|
Property and equipment, net |
|
|
|
11,139 |
|
|
|
|
11,593 |
|
|
Debt financing costs, net |
|
|
|
599 |
|
|
|
|
554 |
|
|
Intangible assets, net |
|
|
|
7,072 |
|
|
|
|
6,837 |
|
|
TOTAL ASSETS |
|
$ |
|
75,767 |
|
|
$ |
|
100,744 |
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
|
3,071 |
|
|
$ |
|
3,952 |
|
|
Accrued expenses and other current
liabilities |
|
|
|
3,895 |
|
|
|
|
4,091 |
|
|
Long-term debt, current
portion |
|
|
|
69 |
|
|
|
|
57 |
|
|
Capital lease obligations, current
portion |
|
|
|
285 |
|
|
|
|
820 |
|
|
Recall liability, current
portion |
|
|
|
460 |
|
|
|
|
760 |
|
|
Deferred contract revenues, current
portion |
|
|
|
292 |
|
|
|
|
134 |
|
|
Total current liabilities |
|
|
|
8,072 |
|
|
|
|
9,814 |
|
|
Long-term debt, net of current portion |
|
|
|
51,080 |
|
|
|
|
49,807 |
|
|
Capital lease obligations, net of current
portion |
|
|
|
— |
|
|
|
|
72 |
|
|
Recall liability, net of current portion |
|
|
|
1,971 |
|
|
|
|
2,229 |
|
|
Deferred contract revenues, net of current
portion |
|
|
|
3,500 |
|
|
|
|
3,500 |
|
|
Total liabilities |
|
|
|
64,623 |
|
|
|
|
65,422 |
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
Common stock |
|
|
|
22 |
|
|
|
|
22 |
|
|
Additional paid-in capital |
|
|
|
169,283 |
|
|
|
|
166,085 |
|
|
Accumulated deficit |
|
|
|
(158,161 |
) |
|
|
|
(130,785 |
) |
|
Total stockholders' equity |
|
|
|
11,144 |
|
|
|
|
35,322 |
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
|
75,767 |
|
|
$ |
|
100,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Contact:
BCC Partners
Karen L. Bergman
kbergman@bccpartners.com
(650) 575-1509
Susan M. Pietropaolo
spietropaolo@bccpartners.com
(845) 638-6290
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