Exhibit 99.1
FOR IMMEDIATE RELEASE
Oculus Innovative Sciences Reports
59% Increase in First Quarter Product Revenue
Conference Call Begins at 4:30 p.m. Eastern Time Today
PETALUMA, Calif. (August 5, 2008) Oculus Innovative Sciences, Inc. (NASDAQ: OCLS) today announced
financial and operating results for the first quarter of fiscal year 2009, ended June 30, 2008.
Total revenue for the quarter was $1.2 million, an increase of 39% over $866,000 in the first
quarter of fiscal 2008. Product revenue was $1.0 million, up 59% from $632,000 in the prior year,
primarily due to higher sales in Mexico, Europe and India. Service revenue declined 13% to
$204,000 as a result of the companys focus on increasing product sales worldwide.
We are moving aggressively to capitalize upon our existing regulatory approvals, human clinical
data and partnerships to increase revenue and build a strong financial base. We believe product
revenue will continue to increase as we advance our commercialization efforts in China, Europe,
India, Mexico and the United States, said Hoji Alimi, president and founder of Oculus. In the
quarter we focused on executing our commercial strategy while making progress on multiple fronts.
On the drug development side we await the end-of-Phase II meeting with the FDA, which is scheduled
for late August. Following that meeting we will determine the next steps of our clinical program.
We believe that the U.S. drug development program and related clinical trials will enhance the
value of the Microcyn Technology to partners and to the market.
The gross margin on product revenue for the first quarter of fiscal 2009 was 57%, up from 41% in
the comparable quarter a year ago primarily due to higher sales volume. Operating expenses of $5.6
million were essentially unchanged from the prior year. The loss from operations in the quarter
declined to $5.1 million from a loss from operations of $5.4 million in the first quarter of fiscal
2008. The net loss for the fiscal 2009 first quarter was $5.2 million, or $0.33 per share,
compared with a net loss for the fiscal 2008 first quarter of $5.0 million, or $0.42 per share.
Non-cash stock-compensation expense for the quarter was $456,000, compared with $210,000 in the
same quarter last year.
As of June 30, 2008, Oculus had unrestricted cash and cash equivalents of $11.5 million, compared
with $18.8 million as of March 31, 2008.
Commercial Progress
Oculus is pursuing revenue growth along three fronts: 1) addition of new partners and new
territories, 2) commercialization of new products in existing and new markets, such as the Microcyn
gel and the Microcyn Delivery Device (MDD), and 3) further identification and approval of
additional treatment indications and applications for current products. To highlight the potential
of this third growth category, the company has seen positive clinical evidence from results of
physician studies for the use of Microcyn Technology in abdominal lavage, oral rinse and
post-caesarean sections, among others.
The company has made significant recent progress in each of these areas, including:
| |
|
|
Making initial shipment of Microcyn products to China in July under Oculus agreement with
China Bao Tai (CBT). CBT has licensed two major Chinese distributors Sinopharm (hospitals)
and Lianhua Supermarkets (retail pharmacies) to position Microcyn for the large Chinese
market. Earlier this year, Microcyn was approved by the Chinese State Food and Drug
Administration for the treatment of various acute and chronic wounds, including ulcers, cuts,
contusions and burns. |
| |
| |
|
|
Signing a development agreement with Bayer Australia Animal Health and with Bayer
(Sichuan) Animal Health Co. Ltd. for Microcyn Technology in animal markets for Australia and
China, respectively. Each Bayer unit will be responsible for product development and
regulatory approvals in its respective territory, and each holds a right of first negotiation
to a commercial agreement with Oculus for distribution of the approved product in its
respective territory. |
| |
| |
|
|
Completing development work on a hydrogel formulation of Microcyn that is designed to
address a broad spectrum of applications, including treatment of skin disorders and burns in
wound care, and as an anti-fungal in podiatry. |
| |
| |
|
|
Filing for patent protection for the development-stage MDD wound care device. This device
is intended to accelerate healing by delivering a Microcyn-based solution to the wound site
and transporting organic load from the site via a vacuum process. The MDD is designed to
monitor the wound site and deliver additional Microcyn solution when required, and eliminate
the need for frequent dressing changes at the site, thereby allowing for healthy fibroblast
growth and prevention of infections. In addition, the MDD is designed for use in both
outpatient and in-patient settings. |
| |
| |
|
|
Finalizing development of a proprietary formulation of Microcyn with antimicrobial claims
that we believe will allow us to market in the United States in the over-the-counter oral
care market without the need for further approval by the FDA. The company is seeking to
align itself with an established partner to commercialize this product candidate. |
| |
| |
|
|
Presenting a peer-reviewed abstract relating to the efficacy of Microcyn Technology for
the treatment of atopic dermatitis at the Third Congress of the World Union of Wound Healing
Societies in Toronto in June 2008. |
We have made excellent progress in recent quarters, and over the life of our company, we have
demonstrated the unique and powerful safety, efficacy and healing properties of
Microcyn through use on more than 750,000 patients in 25 clinical trials and in a rigorous Phase II
clinical study in the United States, said Alimi. We believe that advancing our commercial
program has provided Oculus with a strong network of business partners and distributors around the
globe, proven commercial-scale manufacturing capability in Europe and Mexico, and an established
brand name with healthcare professionals. We are well positioned to achieve further progress with
new partners, products and therapeutic applications.
Outlook
Oculus expects to continue to achieve strong growth in sales of Microcyn-based products over the
coming years through international partnerships, although quarterly rates of growth are difficult
to forecast accurately as some marketing approvals and distribution agreements are recent, and
timing of sales and deliveries are variable during introductory stages.
The company is leveraging current 510(k) approvals, results of a Phase II clinical trial and brand
recognition among medical practitioners to begin growing sales in the United States, and is seeking
an expanded label claim that the company expects to further increase domestic sales.
With our current products and partnerships we expect to see continued strong growth this fiscal
year in Mexico, Europe and India, along with a nominal revenue contribution from China. We expect
continued strong revenue growth on a year to year basis, resulting from new partners, new
territories, new products and new applications in conjunction with our established sales,
distribution and manufacturing network, said Alimi.
Conference Call
Oculus management will hold a conference call today to discuss first quarter results and to answer
questions, beginning at 4:30 p.m. Eastern time. Individuals interested in participating in the
call may do so by dialing (800) 232-9476 for domestic callers or (706) 679-2532 for international
callers. Those interested in listening to the conference call live via the Internet may do so at
http://ir.oculusis.com/events.cfm Please log on approximately 30 minutes prior to the presentation
in order to register and download the appropriate software.
A telephone replay will be available for 48 hours following the conclusion of the call by dialing
(800) 642-1687 for domestic callers, or (706) 645-9291 for international callers, and entering
reservation code 57954211. A webcast replay will be available on the site at
http://ir.oculusis.com/events.cfm for one year following the call.
About Oculus
Oculus Innovative Sciences develops, manufactures and markets a family of products based upon the
Microcyn® Technology platform, which is intended to help prevent and treat infections in chronic
and acute wounds. The Microcyn Technology platform features a biocompatible, shelf-stable solution
containing active oxychlorine compounds that is currently commercialized primarily in Europe, India
and Mexico for the treatment of infected wounds. The solutions derived from this platform have
demonstrated, in a variety of research and investigational studies, the ability to treat a wide
range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE),
viruses, fungi and spores. A recent Phase II clinical trial of Microcyn Technology conducted in
the U.S. met its primary endpoints of safety and efficacy for the treatment of mildly infected
diabetic foot ulcers.
Oculus also develops, manufactures and markets a number of devices and products under 510(k)
regulatory approvals to professionals and consumers. The companys headquarters are in Petaluma,
California, with operations in Europe, Latin America and Japan. More information can be found at
www.oculusis.com.
Forward Looking Statements
Except for historical information herein, some matters set forth in this press release are
forward-looking within the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements about Microcyns safety, efficacy and wound
healing capabilities, and the ability of Microcyn to become a new type of drug for comprehensive
treatment of diverse inflammatory conditions. These forward-looking statements are identified by
the use of words such as believe, pursue, intend, design, looking, leverage, seeking
and expects, among others, and include statements about our belief that product revenue will
continue to increase generally or at any specific rate, our belief that we will advance our
commercialization efforts, our belief that the U.S. drug development program and trials will
enhance the value of Microcyn Technology, our ability to successfully pursue revenue growth with
new partners and in new territories, our ability to develop and commercialize new products
(including the MDD), our ability to identify and obtain approval for treatment indications and
applications, the ability of our product and product candidates to address indications as designed
for or as intended, our ability to leverage our current regulatory approvals, expand label claims
and commercialize our products and product candidates over-the-counter or without the need for
further regulatory approval, the ability of our products and products candidates to result in cost
savings, our ability to obtain patent protection for new products and product candidates, and our
ability to identify or align ourselves with new partners. Forward-looking statements in this press
release are subject to certain risks and uncertainties inherent in the Companys business that
could cause actual results to vary, including risks inherent in the development and
commercialization of potential products, the risk that regulatory clinical and guideline
developments may change, the risk that scientific data may not be sufficient to meet
regulatory
standards or receipt of required regulatory clearances or approvals, the risk that clinical results
may not be replicated in actual patient settings, the risk that protection offered by our patents
and patent applications may be challenged, invalidated or circumvented by our competitors, the risk
that present treatment trends will continue and that the available market for our products will not
be as large as expected, the risk that our products will not be able to
penetrate one or more targeted markets, the risk that our work force is inadequate to implement our
business plan, the risk that we are unable to identify or align ourselves with strategic partners,
the risk that revenues will not be sufficient to fund further development and clinical studies, the
Companys future capital needs, and its ability to obtain additional funding and other risks
detailed from time to time in the Companys filings with the Securities and Exchange Commission
including the annual report on Form 10-K for the year ended March 31, 2008. Oculus Innovative
Sciences disclaims any obligation to update these forward-looking statements.
Oculus, Microcyn and Dermacyn are trademarks or registered trademarks of Oculus Innovative
Sciences, Inc. All other trademarks and service marks are the property of their respective owners.
| |
|
|
Contacts: |
|
|
|
|
|
Oculus Innovative Sciences, Inc.
|
|
Lippert/Heilshorn & Associates, Inc. |
|
|
|
Dan McFadden
|
|
Bruce Voss/Don Markley (investors) |
Director of Public and Investor Relations
|
|
(310) 691-7100 |
(425) 753-2105
|
|
bvoss@lhai.com |
dmcfadden@oculusis.com
|
|
dmarkley@lhai.com |
|
|
|
|
|
Jules Abraham (media) |
|
|
(212) 838-3777 |
|
|
jabraham@lhai.com |
Oculus Innovative Sciences, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
| |
|
|
|
|
|
|
|
|
| |
|
For the Three Months |
|
| |
|
Ended June 30, |
|
| |
|
2008 |
|
|
2007 |
|
REVENUE |
|
|
|
|
|
|
|
|
Product |
|
$ |
1,007 |
|
|
$ |
632 |
|
Service |
|
|
204 |
|
|
|
234 |
|
|
|
|
|
|
|
|
Total revenues |
|
|
1,211 |
|
|
|
866 |
|
|
|
|
|
|
|
|
COST OF REVENUES |
|
|
|
|
|
|
|
|
Product |
|
|
438 |
|
|
|
376 |
|
Service |
|
|
198 |
|
|
|
241 |
|
|
|
|
|
|
|
|
Total cost of revenues |
|
|
636 |
|
|
|
617 |
|
|
|
|
|
|
|
|
Gross profit |
|
|
575 |
|
|
|
249 |
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
Research and development |
|
|
2,321 |
|
|
|
2,207 |
|
Selling, general and administrative |
|
|
3,328 |
|
|
|
3,458 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
5,649 |
|
|
|
5,665 |
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(5,074 |
) |
|
|
(5,416 |
) |
Interest expense |
|
|
(162 |
) |
|
|
(339 |
) |
Interest income |
|
|
76 |
|
|
|
206 |
|
Other income (expense), net |
|
|
(39 |
) |
|
|
531 |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,199 |
) |
|
$ |
(5,018 |
) |
|
|
|
|
|
|
|
Net loss per common share: basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.42 |
) |
|
|
|
|
|
|
|
| |
Weighted-average number of shares used in per
common share calculations: Basic and diluted |
|
|
15,924 |
|
|
|
11,844 |
|
|
|
|
|
|
|
|
OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
| |
|
|
|
|
|
|
|
|
| |
|
June 30, |
|
|
March 31, |
|
| |
|
2008 |
|
|
2008 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,455 |
|
|
$ |
18,823 |
|
Accounts receivable, net |
|
|
856 |
|
|
|
770 |
|
Inventory |
|
|
280 |
|
|
|
259 |
|
Prepaid expenses and other current assets |
|
|
1,029 |
|
|
|
1,098 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
13,620 |
|
|
|
20,950 |
|
Property and equipment, net |
|
|
2,243 |
|
|
|
2,303 |
|
Other assets |
|
|
302 |
|
|
|
359 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
16,165 |
|
|
$ |
23,612 |
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS EQUITY
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,792 |
|
|
$ |
2,977 |
|
Accrued expenses and other current liabilities |
|
|
1,379 |
|
|
|
2,460 |
|
Current portion of long-term debt and capital lease obligations |
|
|
1,607 |
|
|
|
2,013 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
4,778 |
|
|
|
7,450 |
|
Deferred revenue |
|
|
499 |
|
|
|
523 |
|
Long-term debt and capital lease obligations, less current portion |
|
|
149 |
|
|
|
211 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
5,426 |
|
|
|
8,184 |
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
Stockholders Equity: |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 100,000,000 shares authorized,
15,923,708 and 15,903,613 shares issued and outstanding at June
30, 2008 (unaudited) and March 31, 2008, respectively. |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
109,519 |
|
|
|
109,027 |
|
Accumulated other comprehensive loss |
|
|
(2,757 |
) |
|
|
(2,775 |
) |
Accumulated deficit |
|
|
(96,025 |
) |
|
|
(90,826 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
10,739 |
|
|
|
15,428 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
16,165 |
|
|
$ |
23,612 |
|
|
|
|
|
|
|
|