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 fourth fiscal quarter and the year ended September 30,
2016, and reported on recent corporate developments.
Corium's fiscal year ends on September 30.
“During the 2016 fiscal year we made outstanding progress in
moving our two lead Alzheimer’s programs forward,” said Peter D.
Staple, President and Chief Executive Officer of Corium.
“Corplex™ Donepezil and Corplex™ Memantine are novel once-weekly
transdermal product candidates that deliver the two most widely
used treatments for patients with Alzheimer’s disease, and would be
the first transdermal dosage forms of these drugs. Our two
Alzheimer’s programs provide a powerful foundation for a
CNS-focused proprietary pipeline. At the beginning of the
fiscal year, we had just initiated our first-in-human clinical
trials of both of these product candidates, and since then we have
generated positive human clinical data. With those results,
we have gained clear regulatory guidance from the FDA on a
streamlined bioequivalence-based development path that applies to
both products. The first of those bioequivalence studies has
just begun, and we look forward to submitting Corium’s first NDA in
2018.”
Fourth Quarter and Fiscal Year 2016
Highlights
- Initiated pilot bioequivalence study for Corplex
Donepezil — Following the submission of
an Investigational New Drug application in September, the company
has completed enrollment and commenced dosing in a pilot
bioequivalence study for Corplex Donepezil, a once-weekly
transdermal therapeutic, compared to daily oral Aricept® (donepezil
hydrochloride) for Alzheimer’s disease. The pilot study is a
crossover study in healthy subjects, and will compare the
steady-state plasma concentrations of the transdermal and oral
products after several weeks of treatment. Based on the pilot
study results, the Company will set the parameters of the pivotal
study based on statistical bioequivalence (BE) criteria. The
pivotal study is expected to start in the second half of 2017 and
will have a duration of approximately 16 weeks, which would enable
Corium to submit a 505(b)(2) New Drug Application (NDA) as early as
mid-2018.
- Streamlined bioequivalence development paths for both
of Corium’s Alzheimer’s programs — In
April 2016, the FDA advised the company that, following
demonstration of bioequivalence between Corplex Donepezil and daily
oral Aricept in the company’s pivotal BE study, additional clinical
efficacy studies will not be required. The company also
reported in August that it received similar written guidance from
the FDA regarding its proposal for a pivotal study based on the
demonstration of bioequivalence between Corplex Memantine and oral
Namenda XR® (memantine HCl) extended release capsules.
- Positive Corplex Donepezil data presented at
Alzheimer's Association International Conference® 2016
— The company presented full clinical trial
results demonstrating sustained and controlled delivery of
donepezil in the plasma concentrations of all subjects treated with
Corium's once-weekly Corplex Donepezil patch, comparable to daily
oral Aricept, which were indicative of bioequivalence.
- Positive Phase 1 clinical results drove advances in
Alzheimer’s programs — The company
separately announced top-line results from Phase 1 studies of
Corplex Donepezil and Corplex Memantine. These studies
demonstrated positive pharmacokinetic data with sustained and
controlled drug delivery, and provided a strong foundation for
advancing clinical development of both product candidates.
- Partner Agile Therapeutics announces completion of
subject visits for Phase 3 trial of Twirla® once-weekly
contraceptive patch — Agile has indicated
that it expects to report top-line data in early January
2017. Corium provided all required clinical trial supplies
and CMC support for the trial in which over 2,000 women
participated. Preparations are currently underway for the
manufacture of commercial quantities of Twirla in Corium’s
state-of-the-art facility.
- Partner Aequus Pharmaceuticals reported successful
outcome of aripiprazole clinical study —
Aequus completed a Phase 1 PK study of its once-weekly transdermal
product candidate incorporating the active ingredient of Abilify®
in December 2015 and, pending approval by Health Canada, is
preparing to initiate a multiple-dose follow-on study prior to the
end of calendar 2016. Under its development agreement with
Aequus, Corium has contributed to the formulation of the
aripiprazole candidate, will have an undisclosed share in Aequus’
revenues from the resulting product, and will be the exclusive
manufacturer of the product.
- Completion of divestiture of Clonidine TDS from Teva to
Mayne Pharma — Corium enabled the
successful transfer of the Clonidine TDS product from Teva
Pharmaceuticals to Mayne Pharma, in connection with Teva’s
divestiture of the product as a result of its acquisition of the
Allergan generics business. Mayne Pharma acquired the rights
to more products divested from Teva than any other
company.
Financial Results for the Quarter and Fiscal Year
Ended September 30, 2016
Corium reported total revenues in the fourth quarter of fiscal
2016 of $7.9 million, compared with $9.3 million in
the fourth quarter of fiscal 2015, and for the fiscal year
ended September 30, 2016, reported total revenues
of $33.0 million, compared with $40.9 million in
fiscal 2015. For fiscal 2016, 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 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 $1.2 million decline in product revenues for fiscal 2016
compared to fiscal 2015 is primarily the result of fewer Fentanyl
TDS units ordered and shipped, which was partially offset by an
increase in revenues from Crest® Whitestrips.
Total research and development (R&D) expenses in the
fourth quarter of fiscal 2016 were $8.2 million, compared
with $8.6 million in the fourth quarter of fiscal 2015,
and for the fiscal year ended September 30, 2016, total
R&D expenses were $32.4 million, compared with $32.5
million in fiscal 2015. For fiscal 2016, R&D
expenses associated with Corium’s investment in its proprietary
product programs increased, including the advancement of Corium's
two programs for Alzheimer's disease through Phase 1 clinical
trials. This increase in R&D spending was offset by a
lower level of resources required for contract research and
development programs, corresponding to the lower level of revenues
from contract research and development.
General and administrative (G&A) expenses in the fourth
quarter of fiscal 2016 were $2.5 million, compared
with $3.0 million in the fourth quarter of fiscal 2015,
and for the fiscal year ended September 30, 2016, G&A
expenses were $11.6 million, compared with $11.2
million in fiscal 2015. The increase in G&A for the
year was primarily attributable to an increase in stock-based
compensation expense and higher personnel costs.
Corium reported a net loss for the fourth quarter of fiscal 2016
of $9.3 million, or $0.42 per share, compared with a
net loss of $8.6 million, or $0.42 per share, in the
fourth quarter of fiscal 2015. For the fiscal year
ended September 30, 2016, Corium reported a net loss
of $36.7 million, or $1.65 per share, compared with
a net loss of $28.5 million, or $1.52 per share, in
fiscal 2015. As of September 30, 2016, there were
22,391,631 shares of Corium common stock outstanding.
Cash and cash equivalents as of September 30,
2016 were $39.8 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
fourth fiscal quarter and year ended September 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 17537774. 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, 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 has
recently completed all subject visits for its Phase 3 trial, 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 August 12,
2016, filed with the Securities and Exchange
Commission on June 30, 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 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.Namenda XR® is a registered trademark of
Merz Pharma GmbH & Co. KGaA.Crest® Whitestrips is a
registered trademark of The Procter & Gamble
Company.Abilify® is a registered trademark of Otsuka Pharmaceutical
Co., Ltd.
|
|
CORIUM INTERNATIONAL, INC. |
|
Condensed Statements of Operations and
Comprehensive Loss |
|
(unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
Three Months
Ended September 30, |
|
YearsEnded September 30, |
|
|
|
2016 |
|
2015 |
|
2016 |
|
|
|
2015 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Product
revenues |
$ |
6,432 |
|
|
$ |
6,047 |
|
|
$ |
25,362 |
|
|
$ |
26,514 |
|
|
Contract
research and development revenues |
|
1,192 |
|
|
|
2,923 |
|
|
5,420 |
|
|
|
12,721 |
|
|
Other
revenues |
|
294 |
|
|
|
296 |
|
|
2,241 |
|
|
|
1,686 |
|
|
Total
revenues |
|
7,918 |
|
|
|
9,266 |
|
|
33,023 |
|
|
|
40,921 |
|
|
Costs and
operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
product revenues |
|
4,422 |
|
|
|
4,239 |
|
|
17,346 |
|
|
|
17,608 |
|
|
Cost of
contract research and development revenues |
|
2,073 |
|
|
|
3,772 |
|
|
10,674 |
|
|
|
16,064 |
|
|
Research and
development expenses |
|
6,121 |
|
|
|
4,784 |
|
|
21,687 |
|
|
|
16,454 |
|
|
General and
administrative expenses |
|
2,460 |
|
|
|
2,993 |
|
|
11,566 |
|
|
|
11,185 |
|
|
Amortization
of intangible assets |
|
170 |
|
|
|
158 |
|
|
659 |
|
|
|
622 |
|
|
Loss on
disposal and sale and leaseback of equipment |
|
13 |
|
|
|
10 |
|
|
15 |
|
|
|
12 |
|
|
Total costs
and operating expenses |
|
15,259 |
|
|
|
15,956 |
|
|
61,947 |
|
|
|
61,945 |
|
|
Loss from operations |
|
(7,341 |
) |
|
|
(6,690 |
) |
|
(28,924 |
) |
|
|
(21,024 |
) |
|
Interest income |
|
29 |
|
|
|
12 |
|
|
171 |
|
|
|
23 |
|
|
Interest expense |
|
(2,015 |
) |
|
|
(1,956 |
) |
|
(7,947 |
) |
|
|
(7,446 |
) |
|
Loss before income
taxes |
|
(9,327 |
) |
|
|
(8,634 |
) |
|
(36,700 |
) |
|
|
(28,447 |
) |
|
Income tax expense |
|
— |
|
|
|
1 |
|
|
3 |
|
|
|
3 |
|
|
Net loss and comprehensive
loss |
$ |
(9,327 |
) |
|
$ |
(8,635 |
) |
|
$ |
(36,703 |
) |
|
$ |
(28,450 |
) |
|
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.42 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.65 |
) |
|
$ |
(1.52 |
) |
|
Weighted average shares
used in computing net loss per share attributable to common
stockholders, basic and diluted |
|
22,365,247 |
|
|
|
20,594,810 |
|
|
|
22,282,599 |
|
|
|
18,709,292 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORIUM INTERNATIONAL, INC. |
|
Condensed Balance Sheets |
|
(In thousands) |
|
(Unaudited) |
|
|
|
|
|
As of September 30, |
|
|
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
39,833 |
|
|
$ |
72,218 |
|
|
Accounts
receivable |
|
|
4,336 |
|
|
|
4,461 |
|
|
Unbilled
accounts receivable |
|
|
346 |
|
|
|
812 |
|
|
Inventories,
net |
|
|
2,424 |
|
|
|
2,902 |
|
|
Prepaid
expenses and other current assets |
|
|
1,341 |
|
|
|
1,367 |
|
|
Total
current assets |
|
|
48,280 |
|
|
|
81,760 |
|
|
Restricted cash |
|
|
666 |
|
|
|
— |
|
|
Property and equipment,
net |
|
|
11,147 |
|
|
|
11,593 |
|
|
Intangible assets,
net |
|
|
7,057 |
|
|
|
6,854 |
|
|
TOTAL ASSETS |
|
$ |
67,150 |
|
|
$ |
100,207 |
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,737 |
|
|
$ |
3,952 |
|
|
Accrued
expenses and other current liabilities |
|
|
4,271 |
|
|
|
4,091 |
|
|
Long-term
debt, current portion |
|
|
77 |
|
|
|
57 |
|
|
Capital
lease obligations, current portion |
|
|
72 |
|
|
|
820 |
|
|
Recall
liability, current portion |
|
|
460 |
|
|
|
760 |
|
|
Deferred
contract revenues, current portion |
|
|
355 |
|
|
|
134 |
|
|
Total
current liabilities |
|
|
7,972 |
|
|
|
9,814 |
|
|
Long-term debt, net of
current portion |
|
|
50,966 |
|
|
|
49,270 |
|
|
Capital lease
obligations, net of current portion |
|
|
— |
|
|
|
72 |
|
|
Recall liability, net
of current portion |
|
|
1,859 |
|
|
|
2,229 |
|
|
Deferred contract
revenues, net of current portion |
|
|
3,500 |
|
|
|
3,500 |
|
|
Total
liabilities |
|
|
64,297 |
|
|
|
64,885 |
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
Common
stock |
|
|
22 |
|
|
|
22 |
|
|
Additional
paid-in capital |
|
|
170,319 |
|
|
|
166,085 |
|
|
Accumulated
deficit |
|
|
(167,488 |
) |
|
|
(130,785 |
) |
|
Total
stockholders’ equity |
|
|
2,853 |
|
|
|
35,322 |
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
67,150 |
|
|
$ |
100,207 |
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Contact:
SMP Communications
Susan M. Pietropaolo
susan@smpcommunications.com
(201) 923-2049
CORIUM INTERNATIONAL, INC. (NASDAQ:CORI)
Historical Stock Chart
From Mar 2024 to Apr 2024
CORIUM INTERNATIONAL, INC. (NASDAQ:CORI)
Historical Stock Chart
From Apr 2023 to Apr 2024