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, 2018 and reported on recent
corporate developments. Corium's fiscal year ends
on September 30.
Corporate Highlights
- Corplex™ Donepezil on track for filing —
Corium has completed treatment in all of the ancillary clinical
studies required for its New Drug Application (NDA) for Corplex
Donepezil, a once-weekly patch that delivers the most commonly
prescribed medication for Alzheimer’s patients. These studies
included standard skin tolerability, alternative patch application
site and heat effect studies. Corium remains on track to
submit a Section 505(b)(2) NDA in the first quarter of calendar
2019. In addition, Corium reported clinical pharmacodynamic
results at the Alzheimer's Association International Conference®
2018 that provide additional validation of the therapeutic
equivalence between Aricept® and Corplex Donepezil.
- First two key patents issued for Corplex
Donepezil — In June and July, Corium announced the
issuance of two U.S. patents, including composition elements,
unique design features of the drug product and methods to achieve
sustained, controlled and effective delivery of donepezil across
the skin for a 7-day wear period. Eligible for listing in the
FDA Orange Book, these patents establish the foundation of a strong
IP portfolio for the transdermal delivery of donepezil and extend
patent coverage of the product to at least July 2037. Corium
has several additional pending patent applications relating to
various features of Corplex Donepezil, as well as similar
products.
- Pipeline advances in additional indications —
Corium has progressed its development and feasibility evaluation of
several pipeline product candidates, leveraging nonclinical and
clinical studies that the company has already performed. The
pipeline candidates include programs in several important disease
areas including multiple sclerosis, Alzheimer’s and pain
management. Corium anticipates advancing select programs into
clinical pharmacokinetic and safety studies during fiscal
2019.
- Commercial production commenced using expanded capacity
for P&G — Corium’s expanded commercial manufacturing
capacity for Procter & Gamble’s Crest® Whitestrips is
now fully operational and in production. Part of an extended
supply agreement with P&G, the additional production provides
the companies with greater ability to meet significant increases in
demand for Crest Whitestrips.
"We remain on track to file our Corplex Donepezil NDA in the
first quarter of 2019 and look forward to delivering an important
new treatment option for patients with Alzheimer’s disease and
their caregivers,” said Peter D. Staple, President and Chief
Executive Officer of Corium. “We are executing on our
strategic plan to leverage our Corplex technology to expand our
proprietary pipeline with the development of additional
“first-in-patch” transdermal therapeutics. We’ve identified
several promising candidates in therapeutic areas with significant
unmet needs that, based on our initial formulation and feasibility
work, meet our technical and commercial criteria for further
development.”
Financial Results for the Quarter and Nine Months
Ended June 30, 2018
Corium reported total revenues of $7.7 million for the
third quarter of fiscal 2018, compared with $8.1
million for the same period of fiscal 2017, and reported total
revenues of $27.0 million for the nine-month period ended June 30,
2018, compared with $22.4 million for the same period in fiscal
2017. Product revenues were essentially unchanged for the
third quarter of fiscal 2018, compared to the same period in fiscal
2017, primarily as a result of a decrease in Clonidine TDS
revenues, offset by an increase in revenues from Crest Whitestrips
and Fentanyl TDS. Product revenues increased for the
nine-month period ended June 30, 2018, compared to the same period
in fiscal 2017, as revenues from Procter & Gamble increased,
reflecting strong demand for the Crest Whitestrips products.
Contract research and development (R&D) revenues decreased for
the third quarter of fiscal 2018, compared to the same period in
fiscal 2017, as a result of reduced development work for Agile’s
Twirla® product and several other partner programs, partially
offset by higher revenues from activities associated with
implementing the new production capacity for P&G.
Contract R&D revenues increased for the nine-month period ended
June 30, 2018, compared to the same period in fiscal 2017, due to
increased support for Agile’s regulatory activities, increased
product development for Mayne, and the implementation of the new
production capacity for P&G. Total R&D
expenses were $10.6 million in the third quarter of fiscal
2018, compared with $12.1 million in the same period of
fiscal 2017, and were $39.7 million for the nine-month period ended
June 30, 2018, compared with $30.5 million in the same period in
fiscal 2017. The decrease in total R&D expenses for the
third quarter reflects the lower level of clinical activity for
Corplex Donepezil during this period. The increase in total
R&D expenses for the nine-month period was driven by Corium’s
investment in bioequivalence trials for Corplex Donepezil, as well
as the ancillary clinical trials required to support the NDA filing
for the product, in addition to increased expenses associated with
feasibility programs for new products.
General and administrative (G&A) expenses were $3.3 million
for both the third quarter of fiscal 2018 and for the same period
of fiscal 2017, and were $10.7 million for the nine-month period
ended June 30, 2018, compared with $9.3 million in the same period
in fiscal 2017. The increase in G&A expenses for the nine
months was primarily driven by higher one-time legal and outside
services costs in the second quarter, as well as higher stock-based
compensation costs.
Corium reported a net loss of $12.4 million for the third
quarter of fiscal 2018, or $0.34 per share, compared with a
net loss of $13.4 million, or $0.43 per share, in
the same period of fiscal 2017. For the nine-month period
ended June 30, 2018, the net loss was $43.7 million, or $1.21 per
share, compared with a net loss of $34.9 million, or $1.30 per
share, for the same period in fiscal 2017. As of June
30, 2018, there were 36,244,074 shares of Corium common stock
outstanding.
Cash and cash equivalents as of June 30,
2018 were $82.5 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,
2018. 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 4192359. 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. 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, market and growth opportunities and demand for our
commercial products, financial and operating performance, product
pipeline, intellectual property rights and portfolio, clinical
trial and regulatory timing and plans, 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 Annual
Report on Form 10-Q for the quarter ended March 31, 2018, filed
with the Securities and Exchange Commission (SEC)
on May 15, 2018, 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 speak 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. Aricept® is a registered trademark of Eisai R&D Management
Co, Ltd.Crest® Whitestrips is a registered
trademark of The Procter & Gamble Company.Twirla® is a
registered trademark of Agile Therapeutics, Inc.
Investor and Media Contact:SMP CommunicationsSusan M.
Pietropaolosusan@smpcommunications.com(201) 923-2049
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, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenues |
|
$ |
5,901 |
|
|
$ |
5,906 |
|
|
$ |
18,512 |
|
|
$ |
16,301 |
|
Contract
research and development revenues |
|
|
1,529 |
|
|
|
1,936 |
|
|
|
7,813 |
|
|
|
5,320 |
|
Other
revenues |
|
|
240 |
|
|
|
267 |
|
|
|
720 |
|
|
|
801 |
|
Total
revenues |
|
|
7,670 |
|
|
|
8,109 |
|
|
|
27,045 |
|
|
|
22,422 |
|
Costs and operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
product revenues |
|
|
3,507 |
|
|
|
3,935 |
|
|
|
10,806 |
|
|
|
10,892 |
|
Cost of
contract research and development revenues |
|
|
2,339 |
|
|
|
2,977 |
|
|
|
9,238 |
|
|
|
7,891 |
|
Research
and development expenses |
|
|
8,305 |
|
|
|
9,122 |
|
|
|
30,511 |
|
|
|
22,650 |
|
General
and administrative expenses |
|
|
3,325 |
|
|
|
3,284 |
|
|
|
10,728 |
|
|
|
9,288 |
|
Amortization of intangible assets |
|
|
183 |
|
|
|
159 |
|
|
|
541 |
|
|
|
514 |
|
Loss on
disposal of equipment |
|
|
4 |
|
|
|
6 |
|
|
|
4 |
|
|
|
6 |
|
Total
costs and operating expenses |
|
|
17,663 |
|
|
|
19,483 |
|
|
|
61,828 |
|
|
|
51,241 |
|
Loss from
operations |
|
|
(9,993 |
) |
|
|
(11,374 |
) |
|
|
(34,783 |
) |
|
|
(28,819 |
) |
Interest income |
|
|
332 |
|
|
|
77 |
|
|
|
617 |
|
|
|
149 |
|
Interest expense |
|
|
(3,370 |
) |
|
|
(2,087 |
) |
|
|
(7,903 |
) |
|
|
(6,178 |
) |
Loss on extinguishment
of long-term debt |
|
|
— |
|
|
|
— |
|
|
|
(2,258 |
) |
|
|
— |
|
Other income |
|
|
640 |
|
|
|
— |
|
|
|
640 |
|
|
|
— |
|
Loss before income
taxes |
|
|
(12,391 |
) |
|
|
(13,384 |
) |
|
|
(43,687 |
) |
|
|
(34,848 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
2 |
|
|
|
2 |
|
Net loss and
comprehensive loss |
|
$ |
(12,391 |
) |
|
$ |
(13,384 |
) |
|
$ |
(43,689 |
) |
|
$ |
(34,850 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.34 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.21 |
) |
|
$ |
(1.30 |
) |
Weighted-average shares
used in computing net loss per share attributable to common
stockholders, basic and diluted |
|
|
36,214,740 |
|
|
|
31,457,702 |
|
|
|
36,144,746 |
|
|
|
26,784,678 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORIUM INTERNATIONAL,
INC.CONDENSED BALANCE SHEETS(In
thousands, except share and per share
data)(Unaudited)
|
As of June 30, |
|
As of September 30, |
|
2018 |
|
2017 |
|
|
|
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and
cash equivalents |
$ |
82,523 |
|
|
$ |
57,466 |
|
Accounts
receivable |
|
3,556 |
|
|
|
4,641 |
|
Unbilled
accounts receivable |
|
228 |
|
|
|
169 |
|
Inventories |
|
1,686 |
|
|
|
2,300 |
|
Prepaid
expenses and other current assets |
|
924 |
|
|
|
982 |
|
Total
current assets |
|
88,917 |
|
|
|
65,558 |
|
Property and equipment,
net |
|
15,810 |
|
|
|
12,176 |
|
Intangible assets,
net |
|
7,404 |
|
|
|
7,117 |
|
TOTAL ASSETS |
$ |
112,131 |
|
|
$ |
84,851 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
$ |
4,519 |
|
|
$ |
3,978 |
|
Accrued
expenses and other current liabilities |
|
6,860 |
|
|
|
6,411 |
|
Long-term
debt, current portion |
|
49 |
|
|
|
13,172 |
|
Recall
liability, current portion |
|
119 |
|
|
|
114 |
|
Deferred
contract revenues, current portion |
|
137 |
|
|
|
626 |
|
Total
current liabilities |
|
11,684 |
|
|
|
24,301 |
|
Convertible notes,
net |
|
70,021 |
|
|
|
— |
|
Long-term debt, net of
current portion |
|
337 |
|
|
|
39,027 |
|
Recall liability, net
of current portion |
|
1,697 |
|
|
|
1,811 |
|
Deferred contract
revenues, net of current portion |
|
3,500 |
|
|
|
3,500 |
|
Total
liabilities |
|
87,239 |
|
|
|
68,639 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
Common
stock |
|
36 |
|
|
|
36 |
|
Additional paid-in capital |
|
283,826 |
|
|
|
231,457 |
|
Accumulated deficit |
|
(258,970 |
) |
|
|
(215,281 |
) |
Total
stockholders’ equity |
|
24,892 |
|
|
|
16,212 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
112,131 |
|
|
$ |
84,851 |
|
|
|
|
|
|
|
|
|
Source: Corium
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