Exhibit 99.1
FOR IMMEDIATE RELEASE
Oculus Innovative Sciences Announces Fiscal Third Quarter 2008
Quarterly Results and Clinical Update
Highlights
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Completed patient treatment and follow-up in Microcyn® Phase II clinical
trial in mildly infected diabetic foot ulcers |
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Announced upcoming presentation of Microcyn Phase II top-line data in
patients with mildly infected diabetic foot ulcers at DFCon 08 (Diabetic Foot Global
Conference) on March 14, 2008 |
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Entered U.S. distribution agreement with a subsidiary of Animal Health
International, Inc. for Microcyn-based animal health care products |
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Awarded $6.6 million in damages by U.S. Federal Court related to intellectual
property rights litigation |
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Appointed Gregg H. Alton, senior vice president and general counsel of Gilead
Sciences, to Oculus board of directors |
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China Bao Tai completed two randomized controlled clinical trials of Microcyn
Technology in China; submitted data to SFDA for marketing approval |
PETALUMA, Calif. (February 7, 2008) Oculus Innovative Sciences, Inc. (NASDAQ: OCLS) today
announced quarterly results for its fiscal third quarter of 2008, ended December 31, 2007.
Hoji Alimi, CEO and founder, stated, Our results for the quarter are aligned with Oculus
strategic directionto reduce costs in the international markets and primarily invest in U.S.
clinical trials to support FDA approval of Microcyn Technology as a drug. The execution of this
strategy was reflected during the most recent quarter by a 57% decline in international operating
expenses and 5% growth in product revenue. This quarter was significant for Oculus as we completed
our Phase II clinical trial of Microcyn Technology in patients with mildly infected diabetic foot
ulcers. As we had advised, we completed the trial before the end of 2007 and expect to report
top-line data at DFCon 08, one of the worlds premier annual conferences focused on diabetic foot
ulcers.
The primary objective of this Phase II trial is to establish a baseline of safety and to identify
strong trends relative to the clinical benefits of Microcyn in combination therapy with
levofloxacin, which is a systemic antibiotic, and as a monotherapy. The trial was not designed as
a superiority study. The primary endpoint is cure or improvement of infection, with microbiological
response, safety, and wound healing as the secondary and exploratory endpoints. This design
provides various options for analyzing the data, which should provide important information for
designing the Phase III trial.
The recently completed Phase II trial included three different treatment arms for evaluation: 1)
topical Microcyn alone; 2) topical Microcyn in combination with oral levofloxacin; and 3) oral
levofloxacin plus topical saline. Each patient received 10 days of treatment with a 14-day
follow-up. Designed into the trial were three assessment time points at days three, 10, and 24.
As a result of our focus on the U.S. clinical program, we have allocated our financial and
management resources to the clinical trials while reducing our international costs, Alimi added.
We continue to rely on partners to grow our sales to international markets, including China and
India. During the most recent quarter, China Bao Tai, our partner in China, completed two
randomized clinical trials of Microcyn and submitted data to the SFDA requesting approval of
Microcyn-based products in China.
Third Fiscal Quarter 2008 Results (Period ending December 31, 2007)
Revenues for the third fiscal quarter of 2008 were $1.07 million, a 1.3% increase from $1.05
million in the fiscal third quarter of 2007. In the third fiscal quarter of 2008, $843,000 in net
sales of Microcyn were $42,000 higher, or a 5.2% increase, than net sales of $801,000 in the third
fiscal quarter of 2007. The increase was related to a year-over-year increase in product sales in
Europe and India, with a slight decline in sales in Mexico and the United States. In Mexico, the
unit sales to pharmacies grew 21% to 83,400 units from 68,700 units in the year ago period as well
as a 20% increase in the average selling price to pharmacies, while sales to hospitals were lower.
Gross product margins in the third fiscal quarter of 2008 were 40%, compared to 32% in the year-ago
period, primarily based on higher sales volume in Europe. Service revenues for the quarter were
$223,000, down 11.2% from $251,000 in the third fiscal quarter last year.
Operating expenses for the third fiscal quarter of 2008 were $5.88 million, an increase of 8.7% as
compared to $5.41 million in the year-ago period. This increase was primarily attributed to a $1.5
million increase in clinical development costs mostly related to the recently completed Phase II
trial, as well as a build up in research and regulatory teams to support the U.S. trials. The
increase in research and development costs was significantly offset by a decrease in selling,
general and administrative expenses of $1.32 million, or 28.5%, mostly due to year-over-year cost
reductions in Mexico and Europe. International operating expenses were down 57% or $1.29 million
from the year ago period, reflecting our strategy to reduce international costs and to focus the
companys resources on the clinical trials in the United States. Despite declines in international
operating expenses, general and administrative costs increased in the United States, caused by
higher costs associated with being a public company.
Net loss for the third fiscal quarter of 2008 was $5.30 million compared to a net loss of $4.82
million in the fiscal third quarter of 2007. For the third fiscal quarter of 2008, net loss
included $406,000 of non-cash stock-based compensation expenses, compared to $791,000 in the third
fiscal quarter of 2007.
Cash and cash equivalents at December 31, 2007 totaled $10.4 million, compared to cash and cash
equivalents of $14.9 million at September 30, 2007. The
company will need to raise additional capital
through financings or strategic partnerships in order to fund the planned Phase III clinical
trials.
Total outstanding debt at December 31, 2007 was $2.5 million, down from $8.1 million at December
31, 2006.
Fiscal Third Quarter 2008 Corporate Highlights and Business Outlook:
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Oculus Innovative Sciences completed patient treatment and follow-up
in its Phase II clinical trial in mildly infected diabetic foot ulcers. |
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The primary objective of the trial is to obtain
positive clinical trends and safety for Microcyn Technology as either a
combination therapy or monotherapy and clarify design considerations for
larger Phase III trials. |
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Phase II trial was not designed as a superiority
study. Trial endpoints are resolution of infection, microbiologic
response, and safety. |
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Sixty-seven total patients enrolled and randomized
into three treatment arms: 1) topical Microcyn alone 2) topical Microcyn
in combination with oral levofloxacin; and 3) topical saline in
combination with oral levofloxacin. |
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Phase II design provides for optimal Phase III trial
design based on multiple assessments of efficacy at various time points
(days three, 10 and 24). |
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Top-line data to be announced in first quarter of
2008. |
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Oculus Innovative Sciences announced that it will present Microcyn
Phase II top-line data at DFCon 08 (Diabetic Foot Global Conference) on March 14,
2008. |
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In-line with management guidance for top-line data
announcement in first quarter 2008. |
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Trial design allows for multiple outcome assessments
through the identification of strong trends relative to clinical benefits
and by establishing a baseline of safety. |
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Oculus Innovative Sciences entered into an exclusive U.S.
distribution agreement with Walco International, Inc, a subsidiary of Animal
Health International, Inc. for the rights to its Microcyn-based Vetericyn Wound
Spray for use in both companion and production animals. |
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U.S. District Court for the Northern District of California awarded
$6.6 million in damages to Oculus Innovative Sciences and entered a permanent
injunction against defendant Nofil Corporation. Nofil was found liable for breach
of contract and misappropriation of Oculus intellectual property rights related
to its Microcyn Technology. |
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Gregg H. Alton, senior vice president and general counsel of Gilead
Sciences, was appointed to Oculus board of directors. |
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China Bao Tai, Oculus partner in China, completed two randomized
controlled clinical trials of Microcyn Technology in China. |
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One-hundred sixty-two patients enrolled in burn wound study. |
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Thirty-five patients enrolled in chronic wound treatment study. |
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Trial data submitted to Chinese State Food and Drug
Administration (SFDA) in December 2007, seeking marketing approval of
Microcyn-based products in China. |
Conference Call
Oculus management will host a conference call and webcast on Thursday, February 7, 2008, at 4:15
p.m. ET (1:15 p.m. PT). A live broadcast over the Internet will be available at
http://ir.oculusis.com/events.cfm and will be archived for one year. To listen over the phone,
please call 1-877-407-4018 (domestic/toll-free) or 1-201-689-8471 (international). A telephone
replay will be available for 30 days after the call at 1-877-660-6853 (domestic/toll-free), or
1-201-612-7415 (international). Please enter account number 3055 and conference identification
number 270645.
Oculus Innovative Sciences, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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December 31, |
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December 31, |
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2007 |
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2006 |
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2007 |
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2006 |
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REVENUES |
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Product |
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$ |
843 |
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$ |
801 |
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$ |
2,145 |
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$ |
2,742 |
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Service |
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223 |
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251 |
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764 |
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639 |
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Total revenues |
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1,066 |
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1,052 |
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2,909 |
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3,381 |
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COST OF REVENUES |
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Product |
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508 |
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|
542 |
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1,287 |
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|
1,584 |
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Service |
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233 |
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|
218 |
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761 |
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641 |
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Total cost of revenues |
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741 |
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760 |
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2,048 |
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2,225 |
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Gross profit |
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325 |
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292 |
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861 |
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1,156 |
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OPERATING EXPENSES |
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Research and development |
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2,580 |
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795 |
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7,070 |
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2,390 |
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Selling, general and administrative |
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3,299 |
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4,614 |
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10,440 |
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12,480 |
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Total operating expenses |
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5,879 |
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5,409 |
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17,510 |
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14,870 |
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Loss from operations |
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(5,554 |
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(5,117 |
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(16,649 |
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(13,714 |
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Interest expense |
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(199 |
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(305 |
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(844 |
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(565 |
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Interest income |
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150 |
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30 |
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556 |
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130 |
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Other income (expense), net |
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299 |
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565 |
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1,073 |
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657 |
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Net loss |
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(5,304 |
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(4,827 |
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(15,864 |
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(13,492 |
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Preferred stock dividends |
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(121 |
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(363 |
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Net loss available to common stockholders |
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$ |
(5,304 |
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$ |
(4,948 |
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$ |
(15,864 |
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$ |
(13,855 |
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Net loss per common share: basic and diluted |
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$ |
(0.40 |
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$ |
(1.17 |
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$ |
(1.26 |
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$ |
(3.28 |
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Weighted-average number of shares used in
per common share calculations: Basic and
diluted |
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13,264 |
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4,223 |
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12,561 |
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4,222 |
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About Oculus
Oculus Innovative Sciences is a biopharmaceutical company that 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 is a
biocompatible solution containing active oxychlorine compounds. The solutions derived from the
Microcyn Technology 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. The
technology has also demonstrated wound healing in chronic and acute wounds in clinical
investigational studies. It has been commercialized outside of the United States for the treatment
of infected wounds.
Oculus principal operations are in Petaluma, California, and it conducts operations in Europe,
Latin America and Japan through its wholly owned subsidiaries, Oculus Innovative Sciences
Netherlands B.V., Oculus Technologies of Mexico, S.A. de C.V. and Oculus Japan K.K. Oculus website
is 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 our belief that our results are aligned
with our strategic direction, that the design of our Phase II trial should provide important
information for our planned Phase III trial, our continued reliance on our partners to grow sales
in international markets, or that our Phase II trials will be sufficient to allow the Company to
move forward in its clinical program. These forward-looking statements are identified by the use of
words such as believe, expect, plan, and should, among others. These forward-looking
statements are based on Oculus Innovative Sciences, Inc.s current expectations. 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 scientific data may not be
sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals,
the risk that court awarded damages may not be secured, risks that revenues will not reach expected
levels, 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 quarterly report on Form 10-Q for the quarter ended December 31, 2007.
Oculus Innovative Sciences disclaims any obligation to update these forward-looking statements.
Oculus, Microcyn and Vetericyn are trademarks or registered trademarks of Oculus Innovative
Sciences, Inc. All other trademarks and service marks are the property of their respective owners.
Contact:
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Oculus Innovative Sciences, Inc.
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The Ruth Group |
Dan McFadden
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Sara Ephraim (investors) |
Director of Public and Investor Relations
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(646) 536-7002 |
(425) 753-2105
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sephraim@theruthgroup.com |
dmcfadden@oculusis.com |
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Jason Rando / Janine McCargo (media) |
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(646) 536-7025 / 7033 |
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jrando@theruthgroup.com |
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jmccargo@theruthgroup.com |