Filed Pursuant to Rule 433
Issuer Free Writing Prospectus dated December 21, 2006
Relating to Preliminary Prospectus dated December 1, 2006
Registration No. 333-135584
On
December 21, 2006,
Oculus Innovative Sciences, Inc. filed Amendment No. 5 to its
Registration Statement on Form S-1 to update and augment certain disclosures that
had been provided in its
Preliminary Prospectus dated December 1, 2006. For the purpose of clarifying the updates, substantive
disclosures in the preliminary prospectus
included in Amendment No. 5 to the Registration Statement that did not appear in
the Preliminary Prospectus dated December 1, 2006 are set forth below. In addition to the
attached pages, the preliminary prospectus included in Amendment
No. 5 reflects the completion of our
reincorporation into Delaware on December 15, 2006, the implementation of a one-for-four reverse
split of our outstanding common stock, preferred stock, stock options
and warrants, stockholder approval of our 2006 Stock Incentive Plan, and the approval for quotation of our common stock on the Nasdaq Global Market. References to Oculus,
we, us and our refer to Oculus Innovative Sciences, Inc. and its consolidated subsidiaries unless the context requires otherwise.
This free writing
prospectus includes the following sections from the preliminary prospectus
included in Amendment No. 5 to the Registration
Statement, which augment or otherwise
supersede the corresponding parts of the Preliminary Prospectus dated December 1, 2006:
Portions of our Prospectus Summary, including Oculus Innovative Sciences, Inc., Our Solution, Our Strategy and
Summary Consolidated Financial Data.
Risk Factors Risks Related to Our Common Stock Purchasers in this offering will
experience immediate and substantial dilution in the book value of their investment.
Information Regarding Forward-Looking Statements
Use of Proceeds
Dilution
Portions of our Managements Discussion and Analysis of Financial Condition and Results of
Operations, including Overview, Financial Operations Overview, Comparison of Six Months Ended September 30, 2006 and September 30, 2005 Revenues
and Comparison of Years Ended March 31, 2006 and March 31, 2005 Selling, General and Administrative Expense and Liquidity and Capital Resources Contractual Obligations.
Portions of our Business, including Overview, Our Solution, Our
Strategy, Microcyn Platform Technology, Current Regulatory Approvals and Clearances Physician Clinical Studies, Sales
and Marketing, Other Market Opportunities,
Government Regulation Medical Device Regulation, Pharmaceutical Product Regulation and Regulation of Disinfectants and Legal Proceedings.
Related Party Transactions
Principal Stockholders
Shares Eligible for Future Sale Lock-Up Agreements.
Underwriting
Portions of our Notes to Consolidated Financial Statements, including Note 1 The Company, Note 11
Commitments, Contingencies and Other Matters Legal Matters and Proposed Initial Public Offering, Note 16 Segment and Geographic Information and Note 18 Subsequent Events Settlement Agreement Board Nomination.
The issuer has filed a registration statement (including a prospectus) with the Securities and Exchange Commission, or SEC, for the
offering to which this communication relates. Before you invest, you should read the prospectus in
that registration statement and other documents the issuer has filed with the SEC for more complete
information about the issuer and this offering. You may obtain these documents for free by visiting
EDGAR on the SEC website at www.sec.gov or by clicking on the link
above. Alternatively, the issuer,
any underwriter, or any dealer
participating in the offering will arrange to send you the prospectus
if you request it by calling
1-800-990-2788.
Any disclaimers or other notices that may appear below or elsewhere within the email are not
applicable to this communication and should be disregarded. Such disclaimers or other notices were
automatically generated as a result of this communication being sent via an electronic mail system.
Roth Capital Partners
Maxim Group LLC
Brookstreet Securities Corporation
PROSPECTUS
SUMMARY
Before you decide whether to invest in our common stock, you
should carefully read this entire prospectus, including
Risk Factors and the consolidated financial
statements and related notes. In this prospectus,
we, us, our and
Oculus refer to Oculus Innovative Sciences, Inc. and
its consolidated subsidiaries unless the context requires
otherwise.
Oculus
Innovative Sciences, Inc.
We have developed, and manufacture and market, a family of
products intended to help prevent and treat infections in
chronic and acute wounds. Infection is a serious potential
complication in both chronic and acute wounds, and controlling
infection is a critical step in wound healing. Our platform
technology, called Microcyn, is an electrically charged, or
super-oxidized, water-based solution that is designed to treat a
wide range of organisms that cause disease, or pathogens,
including viruses, fungi, spores and antibiotic resistant
strains of bacteria, such as Methicillin-resistant
Staphylococcus aureus, or MRSA, and Vancomycin-resistant
Enterococcus, or VRE, in wounds.
Microcyn has received CE Mark, or European Union certification,
for wound cleaning and reduction of microbial load, three
U.S. Food and Drug Administration, or FDA, 510(k)
clearances as a medical device in wound cleaning, or
debridement, lubricating, moistening and dressing. Microcyn has
also been granted approvals for use as an antiseptic,
disinfectant and sterilant in Mexico, approval for use in
cleaning and debriding in wound management in India and approval
for moistening, irrigating, cleansing and debriding skin lesions
in Canada. In addition, our 510(k) product label states that our
510(k) product is non-irritating and non-sensitizing to skin and
eyes and no special handling precautions are required. We do not
have the necessary regulatory approvals to market Microcyn in
the United States as a drug, nor do we have the necessary
regulatory clearance or approval to market Microcyn in the U.S.
as a medical device for a wound healing indication.
We believe Microcyn provides significant advantages over current
methods of care in the treatment of a wide range of chronic and
acute wounds throughout all stages of treatment. We believe that
Microcyn is the first topical product that is effective against
a broad range of bacteria and other infectious microbes,
including antibiotic resistant strains, such as MRSA and VRE,
without causing irritation of healthy tissue. Unlike most
antibiotics, we believe Microcyn does not target specific
strains of bacteria, a practice which has been shown to promote
the development of resistant bacteria. In addition, our products
are shelf stable, require no special preparation, and are easy
to use.
Clinical testing we conducted in connection with our 510(k)
submissions to the FDA, as well as physician clinical studies,
suggest that our 510(k) product may help reduce a wide range of
pathogens in acute and chronic wounds. These physician clinical
studies suggest that our 510(k) product is easy to use and
complementary to most existing treatment methods in wound care.
Physician clinical studies in the United States also suggest
that our 510(k) Microcyn product may shorten hospital stays,
lower aggregate patient care costs and, in certain cases, reduce
the need for system-wide, or systemic, antibiotics. Physicians
in several countries have also conducted studies in which
Microcyn was used to treat infection in a variety of wounds,
including
hard-to-treat
wounds such as diabetic ulcers and burns, and, in some cases,
reduced the need for systemic antibiotics. The clinical testing
and the physician studies described above were not intended to
be rigorously designed or controlled clinical trials and, as
such, did not have all of the controls required for clinical
trials used to support a new drug application to the FDA.
In July 2006, we completed a controlled clinical trial for
pre-operative skin preparation. After completion of this trial,
the FDA advised us that it is considering adopting new
heightened performance requirements for evaluating efficacy of
products designed to be used in pre-operative skin preparation
such as ours. In discussions with the FDA, the FDA has not
provided us with the definitive timing for, or parameters of,
any such new requirements, and has informally stated that it is
uncertain during what time frame it will be able to do so. We
plan to continue our discussions with the FDA regarding the
possible timing and parameters of any new guidelines for
evaluating efficacy for pre-operative skin preparations.
Depending on the ultimate position of the FDA regarding
performance criteria for pre-operative skin preparations, we may
reassess our priorities,
1
clinical timelines and schedules for pursuing a pre-operative
skin preparation indication or may decide not to pursue this
indication.
We intend to conduct a pilot study in early 2007 to evaluate the
effectiveness of Microcyn in patients with infections in open
wounds. Following completion of the pilot study, we intend to
establish a protocol for a Phase IIb clinical trial in a
similar patient population, which we intend to begin in mid to
late 2007. We anticipate this trial to last approximately
12 months.
We are also conducting laboratory and animal testing to assess
potential applications for Microcyn in several other markets,
including respiratory, dermatology, dental and veterinary
markets. FDA or other governmental approval may be required for
any potential new products or new indications.
We own one issued U.S. patent, 12 pending U.S. patent
applications and 18 foreign pending patent applications relating
to super-oxidized water, methods of using super-oxidized
water-based solution, and aspects of the method and apparatus
for manufacturing super-oxidized water.
We began selling our Microcyn-based product in July 2004 in
Mexico, where we sell through a dedicated contract sales force,
and in October 2004 in Europe, where we have a direct sales
force and exclusive distribution agreements with distributors
which we believe are experienced in supplying the wound care
market. We began selling our products in the United States in
June 2005 and have established a network of one national and
five regional distributors, who are supported by our commercial
team and clinical support staff. We began selling our product in
India in July 2006 through a national distributor, and in
Canada, we have entered into a distribution agreement under
which distribution is expected to commence by late 2007.
The following is a list of the regulatory approvals and
clearances that Microcyn-based products have received for our
most significant or potentially significant markets:
| |
|
|
|
|
|
|
|
Region
|
|
Approval or Clearance
Type
|
|
Year of Approval or
Clearance
|
|
Summary Indication
|
|
|
|
United States
|
|
510(k)
|
|
2005
|
|
Moistening and lubricating
absorbent wound dressings for traumatic wounds.
|
|
|
|
510(k)
|
|
2005
|
|
Moistening and debriding acute and
chronic dermal lesions.
|
|
|
|
510(k)
|
|
2006
|
|
Moistening absorbent wound
dressings and cleaning minor cuts.
|
|
European Union
|
|
CE Mark
|
|
2004
|
|
Debriding, irrigating and
moistening acute and chronic wounds in comprehensive wound
treatment by reducing microbial load and creating moist
environment.
|
|
Mexico
|
|
Product Registration
|
|
2003
|
|
Antiseptic disinfection solution
for high level disinfection of medical instruments, and/or
equipment and clean-rooms, areas of medical instruments,
equipment and clean room areas.
|
|
|
|
Product Registration
|
|
2004
|
|
Antiseptic treatment of wounds and
infected areas.
|
2
| |
|
|
|
|
|
|
|
Region
|
|
Approval or Clearance
Type
|
|
Year of Approval or
Clearance
|
|
Summary Indication
|
|
|
|
Canada
|
|
Class II Medical Device
|
|
2004
|
|
Moistening, irrigating, cleansing
and debriding acute and chronic dermal lesions, diabetic ulcers
and post-surgical wounds.
|
|
India(1)
|
|
Drug License
|
|
2006
|
|
Cleaning and debriding in wound
management.
|
(1) Drug license held by Indian distributor as required by
Indian law.
If we successfully complete additional clinical studies and
receive the necessary FDA regulatory approvals, we plan to
market Microcyn in the United States as a drug.
Our
Solution
We believe our products have the following key features:
|
|
|
| |
|
Wound Care Solution. Our 510(k) product
is cleared for sale in the United States as a medical device in
wound cleaning, or debridement, lubricating, moistening and
dressing. Although we do not have the necessary regulatory
approvals to market Microcyn in the United States as a drug,
laboratory testing and physician clinical studies further
suggest that our 510(k) product may help reduce a wide range of
bacteria that cause infection in a variety of acute and chronic
wounds. In addition, because of its mechanism of action, we
believe that Microcyn does not target specific strains of
bacteria, the practice of which has been shown to promote the
development of resistant bacteria. In physician clinical studies
involving our 510(k) Microcyn product, Microcyn was used both
independent of and in conjunction with other wound care
therapeutic products, data supported that patients generally
experienced less pain, improved mobility and physical activity
levels and better quality of life.
|
| |
| |
|
Non-irritating. Our 510(k) product
label states that our 510(k) product is non-irritating and
non-sensitizing to the skin and eyes. Throughout all our
clinical trials and physician clinical studies to date and since
our initial commercialization of Microcyn in Mexico in 2004, we
have received no reports of serious adverse events related to
the use of Microcyn products.
|
| |
| |
|
Ease of Use. Our 510(k) product label
states that our 510(k) product requires no special handling
precautions. Our products require no preparation before use or
at time of disposal, and caregivers can use our products without
significant training. In addition, Microcyn can be stored at
room temperature. Unlike other super-oxidized water solutions,
which are typically stable for not more than 48 hours, our
laboratory tests show that Microcyn has a shelf life ranging
from one to two years, depending on the size and type of
packaging. Our products are also designed to be complementary to
most advanced technologies used to treat serious wounds, such as
negative pressure wound therapy, jet lavage and
tissue-engineered skin substitutes.
|
| |
| |
|
Cost Effectiveness. The treatment of
many wounds requires extended hospitalization and care,
including the use of expensive systemic antibiotics. Infection
prolongs the healing time and necessitates increased use of
systemic antibiotics. We believe Microcyn has the potential to
help treat infection, accelerate wound healing time and, in
certain cases, may help reduce the need for systemic
antibiotics, thereby lowering overall patient cost.
|
3
Our
Strategy
Our goal is to become a worldwide leader in wound care by
establishing Microcyn as the standard of care for helping to
prevent and treat chronic and acute wounds. We also intend to
leverage our expertise in wound care into additional market
opportunities. The key elements of our strategy include the
following:
|
|
|
| |
|
drive adoption of Microcyn as the standard of care in the wound
care market to help prevent and treat infection;
|
| |
| |
|
obtain additional regulatory approvals in the United States;
|
| |
| |
|
expand our direct sales force and distribution networks;
|
| |
| |
|
pursue opportunities to combine Microcyn with other treatments;
|
| |
| |
|
develop strategic collaborations in the wound care
market; and
|
| |
| |
|
conduct additional tests to assess whether Microcyn can meet
additional regulatory requirements and be used in other markets.
|
Summary
Consolidated Financial Data
The following tables present our summary consolidated financial
data. Our historical results are not necessarily indicative of
the results that may be expected in the future. You should read
this information together with our audited consolidated
financial statements and related notes and the information under
Selected Consolidated Financial Data and
Managements Discussion and Analysis of Financial
Condition and Results of Operations included elsewhere in
this prospectus.
The following tables present our summary consolidated financial
data:
|
|
|
| |
|
on an actual basis;
|
| |
| |
|
on a pro forma, as adjusted, basis to give effect to:
|
|
|
|
| |
|
the conversion of all outstanding shares of our convertible
preferred stock into 4,176,478 shares of our common stock
upon closing of this offering;
|
| |
| |
|
the sale of 3,076,923 shares of common stock in this
offering at an assumed initial public offering price of
$13.00 per share, which is the midpoint of our expected
offering range on the cover page of this prospectus, after
deducting the estimated underwriting discounts and commissions
and estimated offering expenses payable by us; and
|
| |
| |
|
the Bridge Loan, net of fees, resulting in proceeds to us of
$3,950,000 and repayment of the Bridge Loan out of the net
proceeds of this offering.
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended March 31,
|
|
|
Six Months Ended September 30,
|
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
(In thousands, except per share data)
|
|
|
|
|
Consolidated Statements of
Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
|
|
$
|
95
|
|
|
$
|
473
|
|
|
$
|
1,966
|
|
|
$
|
807
|
|
|
$
|
1,942
|
|
|
Service
|
|
|
807
|
|
|
|
883
|
|
|
|
618
|
|
|
|
275
|
|
|
|
388
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
902
|
|
|
|
1,356
|
|
|
|
2,584
|
|
|
|
1,082
|
|
|
|
2,330
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product(1)
|
|
|
1,403
|
|
|
|
2,211
|
|
|
|
3,899
|
|
|
|
1,350
|
|
|
|
1,043
|
|
|
Service(1)
|
|
|
1,265
|
|
|
|
1,311
|
|
|
|
1,003
|
|
|
|
497
|
|
|
|
422
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of revenues
|
|
|
2,668
|
|
|
|
3,522
|
|
|
|
4,902
|
|
|
|
1,847
|
|
|
|
1,465
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (loss)
|
|
|
(1,766
|
)
|
|
|
(2,166
|
)
|
|
|
(2,318
|
)
|
|
|
(765
|
)
|
|
|
865
|
|
4
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended March 31,
|
|
|
Six Months Ended September 30,
|
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
(In thousands, except per share data)
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development(1)
|
|
|
1,413
|
|
|
|
1,654
|
|
|
|
2,600
|
|
|
|
965
|
|
|
|
1,595
|
|
|
Selling, general and
administrative(1)
|
|
|
3,918
|
|
|
|
12,492
|
|
|
|
15,933
|
|
|
|
7,704
|
|
|
|
7,867
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
5,331
|
|
|
|
14,146
|
|
|
|
18,533
|
|
|
|
8,669
|
|
|
|
9,462
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(7,097
|
)
|
|
|
(16,312
|
)
|
|
|
(20,851
|
)
|
|
|
(9,434
|
)
|
|
|
(8,597
|
)
|
|
Interest expense
|
|
|
(178
|
)
|
|
|
(372
|
)
|
|
|
(172
|
)
|
|
|
(103
|
)
|
|
|
(261
|
)
|
|
Interest income
|
|
|
3
|
|
|
|
8
|
|
|
|
282
|
|
|
|
68
|
|
|
|
100
|
|
|
Other income (expense), net
|
|
|
(26
|
)
|
|
|
146
|
|
|
|
(377
|
)
|
|
|
(101
|
)
|
|
|
92
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from continuing operations
|
|
|
(7,298
|
)
|
|
|
(16,530
|
)
|
|
|
(21,118
|
)
|
|
|
(9,570
|
)
|
|
|
(8,666
|
)
|
|
Loss on discontinued operations
|
|
|
|
|
|
|
|
|
|
|
(1,981
|
)
|
|
|
(174
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(7,298
|
)
|
|
|
(16,530
|
)
|
|
|
(23,099
|
)
|
|
|
(9,744
|
)
|
|
|
(8,666
|
)
|
|
Preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
(121
|
)
|
|
|
|
|
|
|
(242
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders
|
|
$
|
(7,298
|
)
|
|
$
|
(16,530
|
)
|
|
$
|
(23,220
|
)
|
|
$
|
(9,744
|
)
|
|
$
|
(8,908
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share: basic
and diluted
|
|
$
|
(1.87
|
)
|
|
$
|
(4.22
|
)
|
|
$
|
(5.60
|
)
|
|
$
|
(2.38
|
)
|
|
$
|
(2.11
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of shares
used in per common share calculations: basic and diluted
|
|
|
3,911
|
|
|
|
3,914
|
|
|
|
4,150
|
|
|
|
4,086
|
|
|
|
4,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss per common
share: basic and diluted
|
|
|
|
|
|
|
|
|
|
$
|
(2.16
|
)
|
|
|
|
|
|
$
|
(0.79
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma weighted-average number
of shares used in per common share calculations: basic and
diluted
|
|
|
|
|
|
|
|
|
|
|
10,759
|
|
|
|
|
|
|
|
11,283
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes the following stock-based compensation charges: |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
Year Ended March 31,
|
|
|
September 30,
|
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
|
|
$
|
|
|
|
$
|
2
|
|
|
$
|
2
|
|
|
$
|
1
|
|
|
$
|
|
|
|
Service
|
|
|
10
|
|
|
|
3
|
|
|
|
1
|
|
|
|
|
|
|
|
1
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
56
|
|
|
|
5
|
|
|
|
52
|
|
|
|
12
|
|
|
|
40
|
|
|
Selling, general and administrative
|
|
|
358
|
|
|
|
2,339
|
|
|
|
542
|
|
|
|
253
|
|
|
|
229
|
|
5
| |
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2006
|
|
|
|
|
|
|
|
Pro Forma
|
|
|
|
|
Actual
|
|
|
As Adjusted
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
(In thousands, except per share data)
|
|
|
|
|
Consolidated Balance Sheet
Data:
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents(1)
|
|
$
|
2,269
|
|
|
$
|
38,907
|
|
|
Working capital
(deficiency)(1)
|
|
|
(797
|
)
|
|
|
36,169
|
|
|
Total
assets(1)
|
|
|
10,056
|
|
|
|
45,289
|
|
|
Total liabilities
|
|
|
9,082
|
|
|
|
8,754
|
|
|
Total stockholders
equity(1)
|
|
|
974
|
|
|
|
36,535
|
|
|
|
|
|
(1) |
|
A $1.00 increase or decrease in the assumed initial public
offering price of $13.00 per share (the midpoint of our
expected offering range on the cover of this prospectus) would
increase or decrease, as applicable, this amount on a pro forma
as adjusted basis by approximately $2,831 assuming the number of
shares offered by us, as set forth on the cover page of this
prospectus, remains the same and after deducting the estimated
underwriting discounts and commissions and our estimated
offering expenses. |
6
RISK
FACTORS
Investing in our common stock involves a high degree of risk.
You should carefully consider the risks described below with all
of the other information included in this prospectus before
making an investment decision. If any of the following risks
actually occur, our business, results of operations or financial
condition would likely suffer. In that case, the market price of
our common stock could decline and you could lose all or part of
your investment in our common stock. Additional risks and
uncertainties not presently known to us or that we currently
deem immaterial may also impair our business operations.
Risks
Related to Our Common Stock
Purchasers
in this offering will experience immediate and substantial
dilution in the book value of their investment.
The initial public offering price of our common stock is
substantially higher than the net tangible book value per share
of our common stock immediately after this offering. Therefore,
if you purchase our common stock in this offering, you will
incur an immediate dilution of $9.90 in net tangible book value
per share from the price you paid, based on the assumed initial
public offering price of $13.00 per share. The exercise of
outstanding options will result in further dilution of your
investment. For additional information, please see
Dilution.
INFORMATION
REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements that involve
risks and uncertainties, such as statements about our plans,
objectives, expectations, assumptions, and future events. In
some cases, you can identify forward-looking statements by
terminology such as anticipate,
estimate, plan, project,
continue, ongoing,
potential, expect, predict,
believe, intend, may,
will, should, could,
would, and similar expressions. These statements
involve estimates, assumptions, known and unknown risks,
uncertainties and other factors that could cause actual results
to differ materially from any future results, performances, or
achievements expressed or implied by the forward-looking
statements. Consequently, you should not place undue reliance on
these forward-looking statements. We discuss many of these risks
in greater detail under the heading Risk Factors
above.
Forward-looking statements include, but are not limited to,
statements about:
|
|
|
| |
|
the progress and timing of our development programs and
regulatory approvals for our products;
|
| |
| |
|
the benefits and effectiveness of our products;
|
| |
| |
|
the development of protocols for clinical studies;
|
| |
| |
|
enrollment in clinical studies;
|
| |
| |
|
the progress and timing of clinical trials and physician studies;
|
| |
| |
|
our expectations related to the use of our proceeds from this
offering;
|
| |
| |
|
our ability to manufacture sufficient amounts of our product
candidates for clinical trials and products for
commercialization activities;
|
| |
| |
|
the outcome of discussions with the FDA and other regulatory
agencies;
|
| |
| |
|
the content and timing of submissions to, and decisions made by,
the FDA and other regulatory agencies, including demonstrating
to the satisfaction of the FDA the safety and efficacy of our
products;
|
| |
| |
|
the ability of our products to meet existing or future
regulatory standards;
|
| |
| |
|
the rate and causes of infection;
|
| |
| |
|
the accuracy of our estimates of the size and characteristics of
the markets which may be addressed by our products;
|
7
|
|
|
| |
|
our expectations and capabilities relating to the sales and
marketing of our current products and our product candidates;
|
| |
| |
|
the execution of distribution agreements;
|
| |
| |
|
the expansion of our sales force and distribution network;
|
| |
| |
|
the establishment of strategic partnerships for the development
or sale of products;
|
| |
| |
|
the timing of commercializing our products;
|
| |
| |
|
our ability to protect our intellectual property and operate our
business without infringing on the intellectual property of
others;
|
| |
| |
|
our ability to continue to expand our intellectual property
portfolio;
|
| |
| |
|
our expectations about the outcome of litigation and
controversies with third parties;
|
| |
| |
|
our ability to attract and retain qualified directors, officers,
employees and advisory board members;
|
| |
| |
|
our relationship with Quimica Pasteur;
|
| |
| |
|
our ability to compete with other companies that are developing
or selling products that are competitive with our products;
|
| |
| |
|
the ability of our products to become the standard of care for
controlling infection in chronic and acute wounds;
|
| |
| |
|
our ability to expand to and commercialize products in markets
outside the wound care market;
|
| |
| |
|
our estimates regarding future operating performance, earnings
and capital requirements;
|
| |
| |
|
our expectations with respect to our microbiology contract
testing laboratory;
|
| |
| |
|
our expectations relating to the concentration of our revenue
from international sales; and
|
| |
| |
|
the impact of the Sarbanes-Oxley Act of 2002 and any future
changes in accounting regulations or practices in general with
respect to public companies.
|
The forward-looking statements speak only as of the date on
which they are made, and, except as required by law, we
undertake no obligation to update any forward-looking statement
to reflect events or circumstances after the date on which the
statement is made or to reflect the occurrence of unanticipated
events. In addition, we cannot assess the impact of each factor
on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking
statements.
This prospectus contains market data that we obtained from
industry sources. These sources do not guarantee the accuracy or
completeness of the information. Although we believe that the
industry sources are reliable, we have not independently
verified the information.
8
USE OF
PROCEEDS
We expect to receive net proceeds of approximately
$34.0 million from this offering, based on an assumed
initial public offering price of $13.00 per share, after
deducting the estimated underwriting discounts and commissions
and estimated offering expenses payable by us. If the
underwriters exercise their over-allotment option in full, our
estimated net proceeds will be approximately $39.6 million,
after deducting the estimated underwriting discounts and
commissions and estimated offering expenses payable by us. A
$1.00 increase or decrease in the assumed initial public
offering price of $13.00 per share (the midpoint of the
range on the cover page of this prospectus) would increase or
decrease, as applicable, the net proceeds to us by approximately
$2.8 million, assuming the number of shares offered by us,
as set forth on the cover page of this prospectus, remains the
same and after deducting the estimated underwriting discounts
and commissions and our estimated offering expenses.
We currently intend to use the proceeds of this offering as
follows:
|
|
|
| |
|
approximately $12.6 million to expand our sales and
marketing capabilities, including the expansion of our direct
sales force in Europe and the United States;
|
| |
| |
|
approximately $13.0 million to fund clinical trials and
related research;
|
| |
| |
|
repayment of $4.0 million in principal and approximately
$35,000 of accrued interest on our $4.0 million Bridge Loan
from one of our directors, Robert Burlingame. The Bridge Loan,
which bears interest at an annual rate of 7%, is due on the
earlier of the date that is 5 business days after the
completion of an initial public offering resulting in gross
proceeds to us of at least $30.0 million or on
November 10, 2007; and
|
| |
| |
|
the remaining proceeds for general corporate purposes, including
working capital.
|
While we have estimated the particular uses for the net proceeds
to be received upon the completion of this offering, the actual
amounts and timing of any expenditures will depend upon the rate
of growth, if any, of our business, the amount of cash generated
by our operations, status of our research and development
efforts, competitive and technological developments and the
amount of proceeds actually raised in this offering. A portion
of the net proceeds may also be used to acquire or invest in
complementary businesses, technologies, services or products,
although we have no agreements with respect to any such
transactions as of the date of this prospectus. Accordingly, our
management will have significant flexibility in applying the net
proceeds from this offering. Pending these uses described above,
we intend to invest the net proceeds in short-term, investment
grade securities.
We believe that the net proceeds from this offering, the
Series C Financing and the Bridge Loan, together with our
future revenues, cash and cash equivalent balances and interest
we earn on these balances will be sufficient to meet our
anticipated cash requirements through at least the next
12 months.
DILUTION
Our historical net tangible book value as of September 30,
2006 was ($1,379,000) or ($0.33) per share of outstanding
common stock. Historical net tangible book value per share
represents the amount of our total tangible assets less total
liabilities, divided by the number of outstanding shares of
common stock on September 30, 2006. Our pro forma net
tangible book value as of September 30, 2006 was $328,000
or $0.04 per share of common stock. Pro forma net tangible
book value per share represents the amount of our total tangible
assets less total liabilities, including the close of the Bridge
Loan net of fees resulting in net proceeds of $3,950,000,
divided by the number of shares of common stock which includes
4,222,731 shares of common stock outstanding as of
September 30, 2006 and the conversion of all shares of our
convertible preferred stock into 4,176,478 shares of our
common stock upon the closing of this offering. Dilution of pro
forma net tangible book value per share represents the
difference between the amount per share paid by purchasers of
shares of common stock in this offering and the pro forma as
adjusted net tangible book value per share of common stock
immediately after completion of this offering. After giving
effect to the sale of 3,076,923 shares of common stock at
an assumed initial public offering price of $13.00 per
share, which is the
9
midpoint of our expected offering range, and after deducting the
estimated underwriting discounts and commissions and estimated
offering expenses payable by us and the repayment of our Bridge
Loan out of the net proceeds of this offering, our pro forma as
adjusted net tangible book value as of September 30, 2006
would have been $35,587,000 or $3.10 per share of common
stock. This represents an immediate increase in net tangible
book value of $3.06 per share of common stock to existing
common stockholders and an immediate dilution in pro forma as
adjusted net tangible book value of $9.90 per share to new
investors purchasing shares of common stock in this offering.
The following table illustrates this per share dilution:
| |
|
|
|
|
|
|
|
|
|
Assumed initial public offering
price per share of common stock
|
|
|
|
|
|
$
|
13.00
|
|
|
Historical net tangible book value
per share at September 30, 2006
|
|
($
|
0.33
|
)
|
|
|
|
|
|
Increase in pro forma net tangible
book value per share attributable to pro forma adjustments
|
|
$
|
0.37
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net tangible book value
per share as of September 30, 2006
|
|
$
|
0.04
|
|
|
|
|
|
|
Increase in pro forma net tangible
book value per share attributable to new investors
|
|
$
|
3.06
|
|
|
|
|
|
|
Pro forma net tangible book value
per share after this offering
|
|
|
|
|
|
$
|
3.10
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilution in pro forma net tangible
book value per share to new investors in this offering
|
|
|
|
|
|
$
|
9.90
|
|
|
|
|
|
|
|
|
|
|
|
A $1.00 increase or decrease in the assumed initial public
offering price of $13.00 per share (the midpoint of our
expected offering range on the cover of this prospectus) would
increase or decrease, as applicable, our pro forma as adjusted
net tangible book value by $2.8 million, pro forma as
adjusted net tangible book value per share by $0.25 per
share and the dilution to investors in this offering by
$0.75 per share, assuming the number of shares offered by
us, as set forth on the cover page of this prospectus, remains
the same and after deducting the estimated underwriting
discounts and commissions and estimated offering expenses
payable by us.
The following table summarizes, as of September 30, 2006,
on the pro forma basis described above, the number of shares of
common stock purchased from us, the total consideration paid and
the average price per share paid to us by existing and new
investors purchasing shares of common stock in this offering
assuming an initial public offering price of $13.00 per
share, which is the midpoint of our expected offering range,
before deducting the estimated underwriting discounts and
commissions and estimated offering expenses.
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Purchased
|
|
|
Total Consideration
|
|
|
Average Price
|
|
|
|
|
Number
|
|
|
Percent
|
|
|
Amount
|
|
|
Percent
|
|
|
Per Share
|
|
|
|
|
Existing stockholders
|
|
|
8,399,209
|
|
|
|
73
|
%
|
|
$
|
62,384,772
|
|
|
|
61
|
%
|
|
$
|
7.43
|
|
|
New investors
|
|
|
3,076,923
|
|
|
|
27
|
%
|
|
|
40,000,000
|
|
|
|
39
|
%
|
|
$
|
13.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
11,476,132
|
|
|
|
100.0
|
%
|
|
|
102,384,772
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A $1.00 increase or decrease in the assumed initial public
offering price of $13.00 per share (the midpoint of our
expected offering range on the cover of this prospectus) would
increase or decrease, as applicable, total consideration paid by
new investors and total consideration paid by all stockholders
by $2.8 million, assuming the number of shares offered by
us, as set forth on the cover of this prospectus, remains the
same.
If the underwriters exercise their over-allotment option in
full, our existing stockholders would own 70% and our new
investors would own 30% of the total number of shares of our
common stock outstanding after this offering.
The number of shares of our common stock referred to above that
will be outstanding immediately after completion of this
offering is based on 4,222,731 shares of our common stock
outstanding as of September 30,
10
2006 and reflects the automatic conversion of our preferred
stock into 4,176,478 shares of common stock and excludes:
|
|
|
| |
|
2,260,263 shares of our common stock issuable upon the
exercise of outstanding stock options and options to be granted
in connection with this offering, and options to be granted to a
new board member, at a weighted-average exercise price of
$5.04 per share;
|
| |
| |
|
1,098,301 shares of our common stock issuable upon the
exercise of outstanding warrants, at a weighted average exercise
price of $10.18 per share;
|
| |
| |
|
215,385 shares of our common stock issuable upon the
exercise of warrants to be issued to the underwriters in
connection with this offering at an exercise price equal to 165%
of the offering price; and
|
| |
| |
|
up to 1,250,000 additional shares of our common stock
reserved for issuance under our 2006 Stock Incentive Plan.
|
If all of our outstanding options and warrants as of
September 30, 2006 were exercised, our pro forma, as
adjusted, net tangible book value per share after this offering
would be $4.09 per share, representing an increase
attributable to new investors of $2.14 per share, and there
would be an immediate dilution of $8.91 per share to new
investors.
In addition, we may choose to raise additional capital due to
market conditions or strategic considerations even if we believe
we have sufficient funds for our current or future operating
plans. To the extent that additional capital is raised through
the sale of equity or convertible debt securities, the issuance
of these securities could result in further dilution to our
stockholders.
11
MANAGEMENTS
DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and
results of operations should be read together with our
consolidated financial statements and related notes included
elsewhere in this prospectus. This discussion contains
forward-looking statements based upon current expectations that
involve risks, uncertainties and assumptions. Our actual results
may differ materially from those anticipated in these
forward-looking statements as a result of various factors,
including those set forth under Risk Factors,
Information Regarding Forward-looking Statements and
elsewhere in this prospectus.
Overview
We have developed and manufacture and market a family of
products intended to help prevent and treat infections in
chronic and acute wounds. Infection is a serious potential
complication in both chronic and acute wounds, and controlling
infection is a critical step in wound healing. Our platform
technology, called Microcyn, is an electrically charged, or
super-oxidized water-based solution, that is designed to treat a
wide range of pathogens, including viruses, fungi, spores and
antibiotic resistant strains of bacteria such as
Methicillin-resistant Staphylococcus aureus, or MRSA, and
Vancomycin-resistant Enterococcus, or VRE, in wounds.
Microcyn has received CE Mark approval for wound cleaning and
reduction of microbial loads, three U.S. FDA 510(k) clearances
as a medical device in wound debridement, lubricating,
moistening and dressing. Microcyn has also been granted
approvals for use as an antiseptic, disinfectant and sterilant
in Mexico, approval for use in cleaning and debriding in wound
management in India, and approval for moistening, irrigating,
cleansing and debriding skin lesions in Canada. In addition, our
510(k) product label states that our 510(k) product is
non-irritating and non-sensitizing to skin and eyes and no
special handling precautions are required. We do not have the
necessary regulatory approvals to market Microcyn in the United
States as a drug, nor do we have the necessary regulatory
clearance or approval to market Microcyn in the U.S. as a
medical device for a wound healing indication.
We believe that Microcyn may be the first topical product that
is effective against a broad range of bacteria and other
infectious microbes without causing toxic side effects on, or
irritation of, healthy tissue. Unlike most antibiotics,
including antibiotic resistant strains, such as MRSA and VRE, we
believe Microcyn does not target specific strains of bacteria, a
practice which has been shown to promote the development of
resistant bacteria. In addition, our products are shelf stable,
require no special preparation and are easy to use.
We currently sell Microcyn in the United States through a small
commercial team and through one national and five regional
distributors. In Europe, we have a small direct sales force and
exclusive distribution agreements with four distributors, all of
which are experienced suppliers to the wound care market, with
an aggregate combined sales force of over 25 full-time
equivalent salespeople. In Mexico, we sell through a dedicated
contract sales force, including salespeople, nurses and clinical
support staff, and a network of distributors to both the public
and private sector. The MOH, which approves product selection
and procurement for government hospitals and healthcare
institutions, has approved reimbursement for Microcyn. In India
we sell through a national distributor, and in Canada, we have
entered into a distribution agreement under which distribution
will commence upon required regulatory approvals. We plan to
expand our direct sales force in the United States, Europe and
Mexico to support our distribution network.
Clinical testing we conducted in connection with our 510(k)
submissions to the FDA, as well as physician clinical studies,
suggest that our 510(k) product may help reduce a wide range of
pathogens. These physician clinical studies suggest that our
510(k) product is easy to use and complementary to most existing
treatment methods in wound care. Physician clinical studies also
suggest that our 510(k) Microcyn product may shorten hospital
stays, lower aggregate patient care costs and, in certain cases,
reduce the need for system-wide or, systemic, antibiotics.
Physicians in several countries have also conducted studies in
which Microcyn was used to treat infection in a variety of
wounds, including
hard-to-treat
wounds such as diabetic ulcers and burns, and, in some cases,
reduced the need for systemic antibiotics. The clinical testing
and the physician studies described above were not intended to
be rigorously designed or controlled clinical trials and, as
such, did not have all of the controls required for clinical
trials used to support a new drug application to the FDA.
12
In July 2006, we completed a controlled clinical trial for
pre-operative skin preparation. After completion of this trial,
the FDA advised us that it is considering adopting new
heightened performance requirements for evaluating efficacy of
products designed to be used in pre-operative skin preparation
such as ours. In discussions with the FDA, the FDA has not
provided us with the definitive timing for, or parameters of,
any such new requirements, and has informally stated that it is
uncertain during what time frame it will be able to do so. We
plan to continue our discussions with the FDA regarding the
possible timing and parameters of any new guidelines for
evaluating efficacy for pre-operative skin preparations.
Depending on the ultimate position of the FDA regarding the
performance criteria for pre-operative skin preparations, we may
reassess our priorities, clinical timelines and schedules for
pursuing a pre-operative skin preparation indication or may
decide not to pursue this indication.
We intend to conduct a pilot study in early 2007 to evaluate the
effectiveness of Microcyn in patients with open wounds.
Following completion of the pilot study, we intend to establish
a protocol for a Phase IIb clinical trial in a similar
patient population, which we intend to begin in mid to late
2007. We anticipate this trial to last approximately
12 months. The Phase IIb clinical trial is expected to cost
approximately $4.0 million and will be funded through
proceeds from this offering. We anticipate this clinical trial
to be completed in late 2008.
We are also conducting laboratory and animal testing to assess
potential applications for Microcyn in several other markets,
including respiratory, dermatology, dental and veterinary
markets. FDA or other governmental approvals may be required for
any potential new products or new indicators.
In the event we choose to pursue a partnering arrangement to
commercialize products, we would expect a larger portion of our
revenues would be derived from licensing as opposed to direct
sales.
We also have a non-Microcyn based compound in the research and
development phase. This compound has potential applications in
oncology. We anticipate spending approximately $500,000 on
further clinical studies on this compound, funded by proceeds
from this offering. We expect these studies to be completed in
2008.
We have incurred significant net losses since our inception and
had an accumulated deficit of $59.3 million as of
September 30, 2006. We expect to incur significant expenses
in the foreseeable future as we seek to commercialize our
products, and we cannot be sure that we will achieve
profitability.
We also operate a microbiology contract testing laboratory
division that provides consulting and laboratory services to
companies that design and manufacture biomedical devices, as
well as testing on our products and potential products. Our
testing laboratory complies with U.S. good manufacturing
practices and quality systems regulation. We are in the process
of transitioning our business away from providing laboratory
services to others, as we continue to focus our efforts on
commercializing Microcyn.
13
Financial
Operations Overview
Revenues
We derive our revenues from product sales and service
arrangements. Product revenues are generated from the sale of
Microcyn to hospitals, medical centers, doctors, pharmacies,
distributors and strategic partners, and are generally recorded
upon shipment following receipt of a purchase order or upon
obtaining proof of sell-through by a distributor. Product sales
are made either through direct sales personnel or distributors.
Historically, a significant amount of our product sales have
been in Mexico, and more recently in India as well. The
following table shows our revenues generated from product sales
by country:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months Ended
|
|
|
|
|
Year Ended March 31,
|
|
|
September 30,
|
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
|
|
(In thousands)
|
|
|
(In thousands)
|
|
|
U.S
|
|
$
|
|
|
|
$
|
4
|
|
|
$
|
109
|
|
|
$
|
88
|
|
|
$
|
56
|
|
|
Mexico
|
|
|
95
|
|
|
|
434
|
|
|
|
1,788
|
|
|
|
655
|
|
|
|
1,058
|
|
|
India
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
580
|
|
|
Europe
|
|
|
|
|
|
|
35
|
|
|
|
69
|
|
|
|
64
|
|
|
|
248
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
95
|
|
|
$
|
473
|
|
|
$
|
1,966
|
|
|
$
|
807
|
|
|
$
|
1,942
|
|
Service revenues are derived from consulting and testing
contracts. Service revenues are generally recorded upon
performance under the service contract. Revenues generated from
testing contracts are recorded upon completion of the test and
when the final report is sent to the customer. We have refocused
our business efforts away from consulting and testing services
toward the commercialization of Microcyn. As a result, we expect
service revenues to continue to significantly decline in future
periods.
Cost of
Revenues
Cost of product revenues represents the costs associated with
the manufacturing of our products, including expenses for our
various facilities which are fixed, and related personnel cost
and the cost of materials used to produce our products. Cost of
service revenues consists primarily of personnel related
expenses and supplies.
Research
and Development Expense
Research and development expense consists of costs related to
the research and development of Microcyn and our manufacturing
process, the development of new products and new delivery
systems for our products and to carry out preclinical studies
and clinical trials to obtain various regulatory approvals.
Research and development expense is charged as incurred.
Selling,
General and Administrative Expense
Selling, general and administrative expense consists of
personnel related costs, including salaries and sales
commissions, and education and promotional expenses associated
with Microcyn and costs related to administrative personnel and
senior management. These expenses also include the costs of
educating physicians and other healthcare professionals
regarding our products and participating in industry conferences
and seminars. Selling, general and administrative expense also
includes travel costs, outside consulting services, legal and
accounting fees and other professional and administrative costs.
Stock-Based
Compensation Expense
Prior to April 1, 2006, we accounted for stock-based
employee compensation arrangements in accordance with the
provisions of Accounting Principles Board Opinion No. 25,
or APB No. 25, Accounting for Stock Issued to
Employees, and its interpretations and applied the
disclosure requirements of SFAS No. 148, Accounting
for Stock-Based Compensation-Transition and Disclosure, an
amendment of FASB Statement No. 123. We used the
minimum value method to measure the fair value of awards issued
prior to April 1, 2006 with respect to its application
requirements under SFAS No. 123.
14
Effective April 1, 2006, we adopted
SFAS No. 123(R) Share Based Payment, or
SFAS 123(R). This statement is a revision of
SFAS Statement No. 123, Accounting for
Stock-Based Compensation and supersedes APB Opinion
No. 25, and its related implementation guidance.
SFAS 123(R) addresses all forms of share-based payment, or
SBP, awards including shares issued under employee stock
purchase plans, stock options, restricted stock and stock
appreciation rights. Under SFAS 123(R), SBP awards result
in a cost that will be measured at fair value on the
awards grant date, based on the estimated number of awards
that are expected to vest and will result in a charge to
operations.
Under SFAS 123(R), nonpublic entities, including those that
become public entities after June 15, 2005, that used the
minimum value method of measuring equity share options and
similar instruments for either recognition or pro forma
disclosure purposes under Statement 123 are required to apply
SFAS 123(R) prospectively to new awards and to awards
modified, repurchased or cancelled after the date of adoption.
In addition, SFAS 123(R) requires such entities to continue
accounting for any portion of awards outstanding at the date of
initial application using the accounting principles originally
applied to those awards. Accordingly, we record stock-based
compensation expense relating to awards granted prior to
April 1, 2006 that are expected to vest in periods ending
after April 1, 2006 in accordance with the provisions of
APB No. 25 and related interpretive guidance.
We have adopted the prospective method with respect to
accounting for our transition to SFAS 123(R). Accordingly,
we recognized in salaries and related expense $104,000 of
stock-based compensation expense in the six months ended
September 30, 2006, which represents the intrinsic value of
options granted prior to April 1, 2006 that we continue to
account for using the recognition and measurement principles
prescribed under APB No. 25.
Long-lived
Assets in Geographic Regions
Our long-lived assets are located in three countries: the United
States, the Netherlands, and Mexico. The following table shows
our long-lived asset balances by country:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
Year Ended March 31,
|
|
|
September 30,
|
|
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2005
|
|
|
2006
|
|
|
|
|
(In thousands)
|
|
|
(In thousands)
|
|
|
|
|
U.S.
|
|
$
|
1,057
|
|
|
$
|
1,291
|
|
|
$
|
930
|
|
|
$
|
1,181
|
|
|
$
|
965
|
|
|
Mexico
|
|
|
112
|
|
|
|
165
|
|
|
|
371
|
|
|
|
148
|
|
|
|
388
|
|
|
Europe
|
|
|
144
|
|
|
|
503
|
|
|
|
639
|
|
|
|
487
|
|
|
|
871
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,313
|
|
|
$
|
1,959
|
|
|
$
|
1,940
|
|
|
$
|
1,816
|
|
|
$
|
2,224
|
|
Our international operations are subject to risks, including
difficulties and costs of staffing and managing operations in
certain foreign countries and in collecting accounts receivables
on a timely basis or at all. We plan to continue to expand
internationally to respond to customer requirements and market
opportunities. However, until a payment history is established
over time with customers in a new geography or region, the
likelihood of collecting receivables generated by such
operations could be less than our expectations. As a result,
there is a greater risk that reserves set with respect to the
collection of such receivables may be inadequate.
Because of our international operations, we generate revenues in
foreign currencies and are subject to the effects of exchange
rate fluctuations. Foreign exchange gains or losses as a result
of exchange rate fluctuations in any given period could harm our
operating results and negatively impact our revenues. Further,
if the effective price of our products were to increase as a
result of fluctuations in foreign currency exchange rates,
demand for our products could decline and adversely affect our
results of operations and financial condition.
In addition, changes in policies or laws of the United States or
foreign governments resulting in, among other things, changes in
regulations and the approval process, higher taxation, currency
conversion limitations,
15
restrictions on fund transfers or the expropriation of private
enterprises, could reduce the anticipated benefits of our
international expansion.
Discontinued
Operations
On June 16, 2005, we entered into a series of agreements
with Quimica Pasteur, or QP, a Mexico-based distributor of
pharmaceutical products to hospitals and health care entities
owned and/or
operated by the Mexican Ministry of Health, or MOH. These
agreements provided, among other things, for QP to act as our
exclusive distributor of Microcyn to the MOH for a period of
three years.
In connection with these agreements, we were granted an option
to acquire all except a minority share of the equity of QP
directly from its principals in exchange for 150,000 shares
of common stock, contingent upon QPs attainment of certain
financial milestones. Two of our employees were appointed as
officers of QP, which resulted in the establishment of financial
control of QP by our company under applicable accounting
literature. In addition, due to its liquidity circumstances, QP
was unable to sustain operations without our financial and
management support. Accordingly, QP was deemed to be a variable
interest entity in accordance with FIN 46R and the results
of QP were therefore consolidated with our financial statements
for the period from June 16, 2005 through March 26,
2006, the effective termination date of the distribution and
related agreements.
In connection with an audit of QPs financial statements in
late 2005, we were made aware of a number of facts that
suggested that QP or its principals may have engaged in some
form of fraudulent tax avoidance practice prior to the execution
of the agreements between our company and QP. We did not
discover these facts prior to our execution of these agreements
or for several months thereafter. Our prior independent auditors
informed us that we did not have effective anti-fraud programs
designed to detect the activities in which QPs principals
engaged or the personnel to effectively evaluate and determine
the accounting for non-routine or complex accounting
transactions. Our audit committee engaged an outside law firm to
conduct an investigation whose findings implicated QPs
principals in a systemic tax avoidance practice prior to
June 16, 2005. Based on the results of this investigation,
we terminated our agreements with QP on March 26, 2006. We
estimate that QPs liability for taxes, interest and
penalties related to these practices could amount to
$7 million or more. QP had a well-established relationship
with the MOH. Although we lost the benefit of this relationship
when we terminated our agreements with QP, we continue to sell
to the MOH through our dedicated direct sales force and through
other distributors. As of September 30, 2006, our sales to
the MOH were not negatively affected by the termination of our
relationship with QP and we do not expect that it will have a
significant effect on sales to the MOH in the future.
In accordance with SFAS 144, we have reported QPs
results for the period of June 16, 2005 through
March 26, 2006 as discontinued operations because the
operations and cash flows of QP have been eliminated from our
ongoing operations as a result of the termination of these
agreements. We no longer have any continuing involvement with QP
as of the date on which the agreements were terminated. Amounts
associated with the loss upon the termination of the agreements
with QP, which consisted of funds we advanced to QP to provide
it with working capital, are presented separately from QPs
operating results.
Comparison
of Six Months Ended September 30, 2006 and
September 30, 2005
Revenues
Revenues increased $1.2 million, or 116%, to
$2.3 million for the six months ended
September 30, 2006, from $1.1 million for the
six months ended September 30, 2005. Product revenues
increased $1.1 million, or 140%, to $1.9 million for
the six months ended September 30, 2006, from $807,000
for the six months ended September 30, 2005. This
increase was primarily due to $580,000 in sales to a new
customer, Alkem Laboratories Limited, in India, during the
six months ended September 30, 2006. Sales to India,
which amounted to $580,000, were reported as part of our Europe
business which totaled $828,000 in product revenues for the six
months ended September 30, 2006. Other product revenues
from Europe were $248,000. Microcyn product revenues generated
in European countries increased by $184,000 from the six months
ended September 30, 2005, to the six months ended
September 30, 2006, due to continued penetration into the
hospital markets by our direct sales force in Europe.
Additionally, Microcyn product revenues in Mexico
16
increased by $403,000 from the six months ended
September 30, 2005, to the six months ended
September 30, 2006, due to continued penetration into the
hospital markets by our direct sales force in Mexico.
Service revenues increased $113,000, or 41%, to $388,000 for the
six months ended September 30, 2006, from $275,000 for
the six months ended September 30, 2005.
We expect that product revenues will continue to increase as we
expand our sales and marketing efforts worldwide. As of
September 30, 2006, sales of our product to the MOH were
not negatively affected by the termination of our relationship
with QP. We expect that our service revenues will significantly
decline in future periods, as we continue to implement our
strategy of focusing primarily on our Microcyn business.
Comparison
of Years Ended March 31, 2006 and March 31,
2005
Selling,
General and Administrative Expense
Selling, general and administrative expense increased
$3.4 million, or 28%, to $15.9 million during the year
ended March 31, 2006, from $12.5 million during the
year ended March 31, 2005. This increase was partially due
to a $1.5 million increase in United States selling,
general and administrative expense primarily as a result of
higher outside consulting and service fees during the year ended
March 31, 2006. Specifically, outside accounting fees
increased by $653,000 due to the preparation and completion of
an audit of our last four fiscal years, legal fees increased by
$507,000 due to expanded intellectual property and general legal
support, and outside consulting and service fees increased by
$294,000 due to consulting expenses related to the marketing of
our products in Asia.
In addition, sales and marketing expense in Europe increased
$429,000 due to the hiring of additional sales and marketing
personnel during the year ended March 31, 2006.
Selling, general and administrative expense in Mexico increased
$3.3 million in the year ended March 31, 2006 compared
to the prior year primarily due to expanded sales and marketing
efforts in Mexico, as well as non-recurring charges associated
with the relocation of our Mexican subsidiarys facility.
During the year ended March 31, 2006, we began utilizing
75 full-time, direct sales personnel in the major districts
of Mexico, dedicated to the sale of Microcyn60 in the hospital
and pharmacy markets in Mexico. As a result, sales and marketing
expense in Mexico increased $2.7 million during the year
ended March 31, 2006, compared to the prior year.
The increase in selling, general and administrative expense was
offset by a $1.8 million decrease in non-cash stock
compensation expense in the year ended March 31, 2006
compared to the prior year. Approximately $1.7 million of
non-cash stock-based compensation expense incurred in the year
ended March 31, 2005 was related to the grant of an option
to purchase 300,000 shares of common stock to our Chief
Executive Officer.
Liquidity
and Capital Resources
Contractual
Obligations
As of March 31, 2006, we had contractual obligations as follows
(long-term debt and capital lease amounts include principal
payments only):
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
|
Less than
|
|
|
|
|
|
|
|
|
After
|
|
|
|
|
Total
|
|
|
1 year
|
|
|
1-3 years
|
|
|
4-5 years
|
|
|
5 years
|
|
|
|
|
(in thousands)
|
|
|
|
|
Long-term debt
|
|
$
|
714
|
|
|
$
|
504
|
|
|
$
|
93
|
|
|
$
|
117
|
|
|
$
|
|
|
|
Capital leases
|
|
|
56
|
|
|
|
15
|
|
|
|
41
|
|
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
878
|
|
|
|
341
|
|
|
|
340
|
|
|
|
197
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,648
|
|
|
$
|
860
|
|
|
$
|
474
|
|
|
$
|
314
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
BUSINESS
Overview
We have developed and manufacture and market, a family of
products intended to help prevent and treat infections in
chronic and acute wounds. Infection is a serious potential
complication in both chronic and acute wounds, and controlling
infection is a critical step in wound healing. Our platform
technology, called Microcyn, is an electronically charged, or
super-oxidized, water-based solution that is designed to treat a
wide range of organisms that cause disease, or pathogens,
including viruses, fungi, spores and antibiotic resistant
strains of bacteria such as Methicillin-resistant
Staphylococcus aureus, or MRSA, and Vancomycin-resistant
Enterococcus, or VRE, in wounds. We do not have the
necessary regulatory approvals to market Microcyn in the United
States as a drug, nor do we have the necessary regulatory
clearance or approval to market Microcyn in the U.S. as a
medical device for a wound healing indication. Our 510(k)
product is cleared for sale in the United States as a medical
device in wound cleaning, or debridement, lubricating,
moistening and dressing. Clinical testing we conducted in
connection with our submissions to the FDA, as well as physician
clinical studies suggest that our 510(k) product may help reduce
a wide range of pathogens in acute and chronic wounds. These
physician clinical studies suggest that our 510(k) product is
easy to use and complementary to most existing treatment methods
in wound care. Physician clinical studies in the United States
suggest that our 510(k) product may shorten hospital stays,
lower aggregate patient care costs and, in certain cases, reduce
the need for system-wide or, systemic, antibiotics.
In 2005, chronic and acute wound care represented an aggregate
of $9.6 billion in global product sales, of which
$3.3 billion was spent for the treatment of skin ulcers,
$1.6 billion to treat burns and $4.7 billion for the
treatment of surgical and trauma wounds, according to Kalorama
Information, a life sciences market research firm. We believe
our addressable market for the treatment of skin ulcers is
approximately $1.3 billion, $300 million for the
treatment of burns and $700 million for the treatment of
surgical and trauma wounds. Common methods of controlling
infection, including topical antiseptics and antibiotics, have
proven to be only moderately effective in combating infection in
the wound bed. However, topical antiseptics tend to inhibit the
healing process due to their toxicity and may require
specialized preparation or handling. Antibiotics can lead to the
emergence of resistant bacteria, such as MRSA and VRE. Systemic
antibiotics may not be effective in controlling infection in
patients with disorders affecting circulation, such as diabetes,
which are commonly associated with chronic wounds. As a result,
no single treatment is used across all types of wounds and
stages of healing.
We believe Microcyn provides significant advantages over current
methods of care in the treatment of a wide range of chronic and
acute wounds throughout all stages of treatment. These stages
include cleaning, or debridement, prevention and treatment of
infections and wound moistening. We believe that Microcyn may be
the first topical product that is effective against a broad
range of bacteria and other infectious microbes including
antibiotic resistant strains such as MRSA and VRE, without
causing irritation of healthy tissue. Unlike most antibiotics,
we believe Microcyn does not target specific strains of
bacteria, a practice which has been shown to promote the
development of resistant bacteria. In addition, our products are
shelf stable, require no special preparation, and are easy to
use.
Our goal is to become a worldwide leader in wound care by
establishing Microcyn as the standard of care for helping to
prevent and treat infections in chronic and acute wounds. We
currently have, and intend to seek additional regulatory
clearances and approvals to market Microcyn worldwide. In July
2004, we began selling Microcyn in Mexico after receiving
approval from the Mexican Ministry of Health, or MOH, for the
use of Microcyn as an antiseptic, disinfectant and sterilant.
Since then, physicians in the United States, Europe and Mexico
have conducted twelve physician clinical studies assessing
Microcyns use in the treatment of infections in a variety
of wounds, including
hard-to-treat
wounds such as diabetic ulcers and burns. These studies were not
intended to be rigorously designed or controlled clinical trials
and, as such, did not have all of the controls required for
clinical trials used to support an NDA submission to the FDA in
that they did not include blinding, randomization, predefined
clinical end points, use of placebo and active control groups or
U.S. good clinical practices requirements. We used the data
generated from some of these studies to support our application
for the CE Mark, or European Union certification, for wound
cleaning and reduction of infection. We received the
CE Mark in November 2004 and additional international
approvals in Canada,
18
Mexico and India. Microcyn has also received three
FDA 510(k) clearances for use as a medical device in wound
cleaning, or debridement, lubricating, moistening and dressing,
including traumatic wounds and acute and chronic dermal lesions.
In July 2006, we completed a controlled clinical trial for
pre-operative skin preparation. After completion of this trial,
the FDA advised us that it is considering adopting new
heightened performance requirements for evaluating efficacy of
products designed to be used in pre-operative skin preparation
such as ours. In discussions with the FDA, the FDA has not
provided us with the definitive timing for, or parameters of,
any such new requirements, and has informally stated that it is
uncertain during what time frame it will be able to do so. We
plan to continue our discussions with the FDA regarding the
possible timing and parameters of any new guidelines for
evaluating efficacy for pre-operative skin preparations.
Depending on the ultimate position of the FDA regarding
performance criteria for pre-operative skin preparations, we may
reassess our priorities, clinical timelines and schedules for
pursuing a pre-operative skin preparation indication or may
decide not to pursue this indication.
We intend to conduct a pilot study in early 2007 to evaluate the
effectiveness of Microcyn in patients with infections in open
wounds. Following completion of the pilot study, we intend to
establish a protocol for a Phase IIb clinical trial in a
similar patient population, which we hope to begin in mid to
late 2007. We anticipate this trial to last approximately
12 months.
We also are conducting laboratory and animal testing to assess
potential applications for Microcyn in several other markets,
including respiratory, dermatology, dental and veterinary
markets, and FDA or other governmental approvals may be required
for any potential new products or new indications.
We currently sell Microcyn in the United States through one
national and five regional distributors who are supported by our
commercial team and clinical support staff. In October 2006, we
initiated a focused U.S.-based sales effort to increase the
awareness of Microcyn at selected wound treatment centers in a
major metropolitan area, and, if this strategy is successful, we
intend to target other metropolitan areas in 2007 and 2008. In
Europe, we sell Microcyn through exclusive distribution
agreements with distributors, all of which, we believe, are
experienced suppliers to the wound care market, supported by our
direct sales force. In Mexico, we sell Microcyn through a
network of distributors and through a contract sales force,
including salespeople, nurses and clinical support staff. We
plan to continue to expand our sales and marketing force to
support our distribution network. In India we sell through a
national distributor and in Canada, we have entered into a
distribution agreement under which distribution will commence
upon required regulatory approvals.
Our goal is to achieve the following milestones through 2009:
2007
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| |
|
Initiate and complete pilot study for Microcyn in the treatment
of infections in open wounds
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| |
|
Initiate enrollment for Phase IIb clinical trial for Microcyn in
the treatment of infections in open wounds
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| |
| |
|
Initiate several physician-sponsored studies in the United
States, Europe and India
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| |
|
Initiate 510(k) clearance process for next generation Microcyn
product formulation
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Execute distribution agreements for Microcyn in select European,
Asian and South American countries
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Expand U.S. sales force to cover additional major U.S.
metropolitan areas
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2008
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| |
|
Receive 510(k) marketing clearance for next generation Microcyn
product formulation
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2009
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Data expected from Phase IIb clinical trial for Microcyn in the
treatment of infections in open wounds
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| |
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|
Initiate strategic partner discussions for Microcyn in the
treatment of infections in open wounds
|
19
We cannot guarantee that we will obtain on timely basis, if at
all, the necessary FDA approval to market Microcyn in the United
States for the treatment of infection in open wounds. A number
of factors can delay or prevent completion of human clinical
trials, particularly patient recruitment. Moreover, many drug
candidates fail to successfully complete clinical trials. After
an NDA is filed with the FDA, the FDA commences an in-depth
review of the NDA that takes ten months to a year to complete
but may take longer. In addition, we cannot guarantee that we
will obtain on a timely basis, or at all, the necessary 510(k)
clearances for the next generation Microcyn product formulation.
The milestones described above assume that we complete our
clinical trials for the treatment of infection in open wounds
and that the results from these clinical trials support an NDA
filing and that our products will be commercially viable. We
cannot guarantee that we will find appropriate distribution or
strategic partners, generate revenue sufficient to fund our cash
flow needs or that we will meet any of the milestones described
above in a timely manner or at all.
We also operate a microbiology contract testing laboratory
division that provides consulting and laboratory services to
companies that design and manufacture biomedical devices, as
well as testing on our products and potential products. Our
testing laboratory complies with U.S. good manufacturing
practices and quality systems regulation. We are in the process
of transitioning our business away from providing laboratory
services to others, as we continue to focus our efforts on
commercializing Microcyn.
Our
Solution
We believe Microcyn has potential advantages over current
methods of care in the treatment of chronic and acute wounds,
including the following:
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Wound Care Solution. Our 510(k) product
is cleared as a medical device for sale in the United States in
wound cleaning, or debridement, lubricating, moistening and
dressing. Although we do not have the necessary regulatory
approvals to market Microcyn in the United States as a drug,
laboratory testing and physician clinical studies further
suggest that our 510(k) Microcyn product may be effective
against a wide range of bacteria that cause infection in a
variety of acute and chronic wounds. In addition, because of its
mechanism of action, we believe Microcyn does not target
specific strains of bacteria, the practice of which has been
shown to promote the development of resistant bacteria. In
physician clinical studies involving our 510(k) Microcyn product
was used both independent of and in conjunction with other wound
care therapeutic products, data supported that patients
generally experienced less pain, improved mobility and physical
activity levels and better quality of life.
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Non-irritating. Our 510(k) product
label states that our 510(k) product is non-irritating and
non-sensitizing to the skin and eyes. Throughout all our
clinical trials and physician clinical studies to date and since
our first commercial sale of Microcyn in Mexico in 2004, we have
received no reports of serious adverse events related to the use
of Microcyn products.
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|
Ease of Use. Our 510(k) product label
states that our 510(k) product requires no special handling
precautions. Our products require no preparation before use or
at time of disposal, and caregivers can use our products without
significant training. In addition, Microcyn can be stored at
room temperature. Unlike other super-oxidized water solutions,
which are typically stable for not more than 48 hours, our
laboratory tests show that Microcyn has a shelf life ranging
from one to two years depending on the size and type of
packaging. Our products are also designed to be complementary to
most advanced technologies to treat serious wounds, such as
negative pressure wound therapy, jet lavage and
tissue-engineered skin substitutes.
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Cost-Effectiveness. The treatment of
many wounds requires extended hospitalization and care,
including the use of expensive systemic antibiotics. Infection
prolongs the healing time and necessitates increased use of
systemic antibiotics. We believe that Microcyn has the potential
to help treat infection, accelerate healing time and, in certain
cases, may help reduce the need for systemic antibiotics,
thereby lowering overall patient cost.
|
20
Our
Strategy
Our goal is to become a worldwide leader in wound care by
establishing Microcyn as the standard of care for helping to
prevent and treat infections in chronic and acute wounds. We
also intend to leverage our expertise in wound care into
additional market opportunities. The key elements of our
strategy include the following:
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| |
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Drive adoption of Microcyn as the standard of care in the
wound care market to help prevent and treat infection
|
We believe our products are well positioned to become the
standard of care in helping to prevent and treat infection. We
seek to drive adoption of Microcyn as the standard of care in
the wound care market through data from physician clinical
studies, our own clinical trials and key opinion leader
programs. We intend to continue to maintain a marketing presence
in key medical communities throughout the world through targeted
direct marketing and sponsorships of physician presentations at
medical conferences and seminars.
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Obtain additional regulatory approvals in the United
States
|
We intend to seek additional regulatory clearances and
approvals, which we believe will allow us to accelerate adoption
of our products by wound care specialists worldwide. Our current
focus is on developing a well-defined, well-controlled clinical
protocol for a Phase IIb trial. To increase our probability
of success in the trial, we intend to conduct a pilot study in
early 2007 to evaluate the effectiveness of Microcyn in subjects
with infections in open wounds. Following completion of the
pilot study, we intend to establish a Phase IIb clinical
trial in a similar patient population.
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|
Expand our direct sales force and distribution
networks
|
We intend to expand our direct sales force and distribution
networks in the United States, Europe and the rest of the world.
In the United States, Europe and Mexico, we sell our products
through distribution networks supported by our direct sales
force. We also have distribution agreements for our products in
India, Southeast Asia and the Middle East. We select
distributors based on their demonstrated expertise in selling to
wound care professionals and facilities. In the United States we
are initiating a series of focused, intense product roll-outs in
large metropolitan areas to increase the awareness of Dermacyn
among healthcare providers. We will continue to expand the
number of metropolitan areas included in this roll-out as we
expand our
U.S.-based
sales force.
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Pursue opportunities to combine Microcyn with other
treatments
|
We believe our products are compatible with and may potentially
enhance the efficacy of a variety of existing wound care
treatment methods including negative pressure wound therapy,
pulse and jet lavage and tissue engineered skin substitutes.
Combining Microcyn with these therapies has been and continues
to be evaluated in physician clinical studies. We believe
combination therapies to treat open wounds are gaining
acceptance by wound care professionals and may prove to be
clinically and commercially attractive.
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|
Develop strategic collaborations in the wound care
market
|
We intend to pursue strategic relationships with respect to both
product development and distribution. To accelerate adoption of
our products, we may enter into strategic relationships with
healthcare companies that have product lines or distribution
channels that are complementary to ours. We believe
collaborations allow us to leverage our resources and
technology. These relationships may take the form of
co-development, co-promotion or distribution agreements. In
addition, we may expand our offerings of new products or
technologies through acquisitions or licensing agreements.
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|
Conduct additional tests to assess whether our Microcyn
platform can meet additional regulatory requirements and be used
in other markets
|
We believe our products have potential applications in several
other large markets, including the respiratory, dermatology,
dental and veterinary markets. We intend to pursue access to
these markets through strategic partnerships.
21
Microcyn
Platform Technology
Mechanism
of Action
We believe Microcyns ability to treat and help prevent
infection and its sterilant properties are based on its uniquely
engineered chemistry. As a result of our proprietary
manufacturing process, Microcyn contains a wide array of
reactive chemicals that, among other things, interact and
inactivate surface proteins on microorganisms and viruses. The
function of these proteins are varied and play significant roles
in cell communication, nutrient and waste transport and other
required functions for cell viability. Once Microcyn surrounds
single cell microorganisms, it damages these proteins, causing
cell membrane rupture, leading to cell death. This destruction
of the cell appears to occur through a fundamentally different
process than that which occurs as a result of contact with a
bleach-based solution because experiments have demonstrated that
Microcyn kills bleach-resistant bacteria. However, the solution
remains non-irritating and human tissues because human cells are
interlocked and prevent Microcyn from targeting and surrounding
single cells topically on the body.
In laboratory tests, Microcyn has been shown to eliminate
certain biofilms. A biofilm is a complex cluster of
microorganisms or bacteria marked by the formation of a
protective shell, allowing the bacteria to collect and
proliferate. It is estimated that over 65% of microbial
infections in the body involve bacteria growing as a biofilm.
Bacteria living in a biofilm typically have significantly
different properties from free-floating bacteria of the same
species. One result of this film environment is increased
resistance to antibiotics and to the bodys immune system.
In chronic wounds, biofilms interfere with the normal healing
process and halt or slow wound closure. In our laboratory
studies, Microcyn was shown to destroy two common biofilms after
five minutes of exposure.
It is widely accepted that reducing inflammation surrounding an
injury or wound is beneficial to wound healing. Our independent
laboratory research suggests that Microcyn may inhibit certain
inflammatory responses from allergy-producing, or mast, cells.
These reactions are critical components of the bodys
natural inflammatory response to injury or wounds. Our
laboratory research suggests that Microcyns interference
with these cells is selective to only the inflammation response
and does not interfere with other functions of these cells.
Additionally, physician clinical studies suggest that Microcyn
only inhibits this response in tissue that is directly exposed
to the solution.
Current
Regulatory Approvals and Clearances
Physician
Clinical Studies
In addition to our clinical trials, several physicians have
conducted twelve clinical studies of Microcyn generating data
suggesting that our 510(k) Microcyn product is non-irritating to
healthy tissue, reduces microbial load, shortens treatment time
and may have the potential to reduce costs to healthcare
providers and patients. We have sponsored the majority of
physicians performing these studies by supplying Microcyn,
unrestricted research grants and paying expenses and honoraria.
In some cases, the physicians who performed these studies also
hold equity in our company. The studies were performed in the
United States, Mexico and Italy, and used various endpoints,
methods and controls (for example, saline, antiseptics and
antibiotics). These studies were not intended to be rigorously
designed or controlled clinical trials and, as such, did not
have all of the controls required for clinical trials used to
support an NDA submission to the FDA in that they did not
include blinding, randomization, predefined clinical endpoints,
use of placebo and active control groups or U.S. good
clinical practice requirements.
Sales and
Marketing
We are developing distribution and sales networks to market our
products domestically and in a number of countries outside the
United States. We expect to expand our existing sales force in
the United States, Europe and Mexico as we obtain additional
regulatory claims. Our products are purchased by hospitals,
physicians, nurses and other healthcare practitioners who are
the primary caregivers to patients being treated for acute or
chronic wounds, as well as those patients undergoing surgical
procedures.
22
Our strategy is to enter into agreements with established
regional distributors, provide ongoing sales support and utilize
clinical studies and key opinion leader programs to accelerate
product adoption. Implementation of our strategy includes the
development of relationships with wound care specialists through
targeted direct marketing and communications programs and
through sponsorship of physician presentations at medical
conferences and seminars.
In the United States, we currently distribute our products
through one national and five regional distributors who are
supported by our commercial team and clinical support staff. In
addition to our distributors, we employ medical and clinical
professionals, with marketing contacts in leading wound care
clinics, hospitals and health care agencies that provide wound
care services. Our U.S. commercial team is initiating a focused
sales strategy that will allow us to increase the awareness of
Microcyn to healthcare providers. This strategy involves
sampling and customer education efforts in a major metropolitan
area. Based on the success of this initial roll-out, we intend
to target other metropolitan areas in 2007 and 2008. We intend
to hire additional salespeople in the United States in the event
we receive FDA approval of our product for additional
indications.
In Europe, we have arrangements with distributors in Germany,
Italy, Sweden and the Czech Republic who are supported by our
sales team. We are actively pursuing additional distribution
arrangements in other European countries. We currently have a
small direct sales force in our European regional sales office
in The Netherlands, and intend to hire additional direct sales
people to support our distributors.
In Mexico, we market our products through our established
distribution network and direct sales organization. We have a
dedicated contract sales force, including salespeople, nurses
and clinical support staff responsible for selling Microcyn to
private and public hospitals and to retail independent
pharmacies.
We have established distribution channels for our disinfectant
and wound care products in India, Bangladesh, Pakistan,
Singapore, United Arab Emirates and Saudi Arabia. In December
2005, we entered into an agreement with Alkem Laboratories, a
large pharmaceutical company in India, which employs more than
800 salespeople servicing the Indian healthcare market. We
commenced sales to Alkem Laboratories in April 2006. Under
the terms of this agreement, Alkem has exclusive rights to
market, distribute and sell our Microcyn-based products in the
Republic of India and the Kingdom of Nepal. During the term of
this agreement, Alkem is entitled to use our patents, trade
secrets, trademarks and other intellectual property rights as to
our Microcyn-based products. However, we will remain the owner
of and reserve such patents, trade secrets, trademarks and other
intellectual property rights. In the event we fail to timely
deliver the ordered quantities, we will be subject to certain
penalties. In addition, if either party fails to fulfill their
respective obligations under the agreement for a period of
180 days, which is not remediated within 30 days of
receiving notice, the other party may terminate the agreement.
The agreement has a five year term and may be renewed after its
initial term for such additional term as the parties agree to in
writing.
Other
Market Opportunities
We are also conducting laboratory and animal testing to assess
potential applications in several other markets and if these
tests yield promising results, we will determine whether to seek
regulatory clearance. We may pursue access to these markets
through strategic partnerships. Some of these market
opportunities include:
Respiratory
Our nasal product candidate is an anti-microbial solution
designed to be self-administered into a patients nasal
cavity for the treatment of chronic rhinosinusitis, or
inflammation of the nasal sinuses. In animal studies, Microcyn
has been shown to kill the bacteria that causes rhinosinusitis.
We are currently conducting pre-clinical animal studies seeking
to support the efficacy and safety of this product candidate.
Rhinosinusitis affects an estimated 35 million people in
the United States. There is no FDA-approved therapy for
chronic rhinosinusitis. Most treatment methods have focused on
the symptoms of the disease and include the use of antibiotics,
antihistamines, corticosteroids and sinus surgery.
23
Dermatology
We believe that our Microcyn technology can be used to develop
products to treat various fungal and bacterial skin infections.
Laboratory and clinical test data support that our technology
may be effective in treating these bacterial and fungal
infections.
Dental
and Oral Care
We believe that our Microcyn technology may be used both as a
mouthwash and a dental rinse, and that early data from physician
studies support its safe use in oral surgery.
Veterinary
Medicine
Our animal wound care product based on Microcyn technology,
Vetericyn, was launched in late 2004 and is currently available
for purchase by veterinarians through MWI Veterinary Supply,
Inc., a distributor of animal health products. However, we have
not generated meaningful revenue from this agreement. Vetericyn
has uses in a variety of applications, including the treatment
of hard-to-heal wounds in horses and other companion animals.
Government
Regulation
Medical
Device Regulation
In 2005, Microcyn received 510(k) clearance as a medical device
for wound cleaning, or debridement, lubricating, moistening and
dressing. Any future product candidates or new applications
using Microcyn that are classified as medical devices will need
approval or clearance by the FDA.
New medical devices, such as Microcyn, are subject to FDA
approval and extensive regulation under the Federal Food Drug
and Cosmetic Act, or FDCA. Under the FDCA, medical devices are
classified into one of three classes: Class I,
Class II or Class III. The classification of a device
into one of these three classes generally depends on the degree
of risk associated with the medical device and the extent of
control needed to ensure safety and effectiveness.
Pharmaceutical
Product Regulation
We have two pharmaceutical product candidates that are regulated
by the FDA and will require approval before we can market or
sell them as drugs. Any future product candidates or new
applications using Microcyn that are classified as drugs will
need approval by the FDA.
In the United States, the FDA regulates drugs under the FDCA and
implementing regulations that are adopted under the FDCA. In the
case of biologics, the FDA regulates such products under the
Public Health Service Act. If we fail to comply with the
applicable requirements under these laws and regulations at any
time during the product development process, approval process,
or after approval, we may become subject to administrative or
judicial sanctions. These sanctions could include the FDAs
refusal to approve pending applications, withdrawals of
approvals, clinical holds, warning letters, product recalls,
product seizures, total or partial suspension of our operations,
injunctions, fines, civil penalties or criminal prosecution. Any
agency enforcement action could have a material adverse effect
on us. The FDA also administers certain controls over the export
of drugs and biologics from the United States.
Regulation
of Disinfectants
In October 2004, we obtained EPA authorization, or registration
for the distribution and sale of our Microcyn based product as a
hospital grade disinfectant. In August 2006, we received a
show cause letter from the EPA stating that it was
prepared to file a civil administrative complaint against us for
violation of federal pesticide legislation in connection with
the sale or distribution of a pesticide that did not meet the
labels efficacy claims unless and until we provide new
information to support the original label claims as a
24
hospital grade disinfectant to the EPA, there will not be any
sales or other distributions of the product in the United States
as a hospital grade disinfectant.
In the United States, the EPA regulates disinfectants as
antimicrobial pesticides under the Federal Insecticide,
Fungicide and Rodenticide Act, or FIFRA, and the implementing
regulations that the EPA has adopted under FIFRA. Before
marketing a disinfectant in the United States, we must satisfy
the EPAs pesticide registration requirements. That
registration process requires us to demonstrate the
disinfectants efficacy and to determine the potential
human and ecological risks associated with use of the
disinfectant. The testing and registration process could be
lengthy and could be expensive. There is no assurance, however,
that we will be able to satisfy all of the pesticide
registration requirements for a particular proposed new
disinfectant product. Once we satisfy the FIFRA registration
requirements for an individual disinfectant, additional FIFRA
regulations will apply to our various business activities,
including marketing, related to that EPA-registered product.
Legal
Proceedings
In March 2006, we filed suit in the U.S. District Court for
the Northern District of California against Nofil Corporation
and Naoshi Kono, its Chief Executive Officer, for breach of
contract, misappropriation of trade secrets and trademark
infringement. We believe that Nofil Corporation violated key
terms of both an exclusive purchase agreement and non-disclosure
agreement by contacting and working with a potential competitor
in Mexico. In the complaint, we seek damages of
$3.5 million and immediate injunctive relief. No trial date
has been set.
In September 2005, a complaint was filed against us in Mexico
claiming trademark infringement with respect to our Microcyn60
mark. To settle this claim we have agreed to cease marketing our
product in Mexico under the name Microcyn60 in Mexico by
September 2007. A second unrelated claim was filed against us in
Mexico in May 2006, claiming trademark infringement with
respect to our Microcyn60 mark in Mexico. We are in discussions
with the claimant to settle the matter.
In September 2006, a consulting firm in Mexico City contacted us
threatening legal action in Mexico, alleging breach of contract
and claiming damages of $225,000. We entered into a settlement
agreement with the consulting firm in December 2006 which
provides for the payment of $115,000 for the dismissal of their
claim and waiver of any previous claims against us.
In April 2005, a former director and Chief Operating
Officer of our company filed an action in the Superior Court of
the State of California, Sonoma County, alleging breach of
employment contract. In the complaint, the plaintiff claims
$300,000 and the right to purchase approximately
150,000 shares of our common stock at $3.00 per share.
We entered into a settlement agreement with the plaintiff in
November 2006 which provides for the payment of $250,000 and the
issuance of a warrant to purchase 50,000 shares of our common
stock exercisable at $3.00 per share. The issuance of warrants
is subject to our obtaining appropriate waivers from our
preferred stockholders, which were received on December 14,
2006, and the cash payment is subject to the closing of an
equity financing resulting in gross proceeds to us of
$10 million or more on the completion of our initial public
offering. The estimated expense of $550,000 will be recorded as
a general and administrative expense in the period the warrants
are issued. Under the terms of the agreement, the plaintiff has
agreed to dismiss his claim and waived any other previous claims
against us. If the claims are litigated, we may incur
considerable litigation costs. We expect our insurance carrier
to cover a portion of the claim.
Except for the foregoing, we are not a party to any material
legal proceedings, and, except as set forth above, management is
not aware of any threatened legal proceedings that it believes
could cause a material adverse impact on our business, financial
condition or results of operations. From time to time, we may be
party to lawsuits in the ordinary course of business.
25
RELATED
PARTY TRANSACTIONS
In accordance with the terms of the underlying option
agreements, the vesting of options to purchase
75,062 shares of our common stock granted to our directors
will be accelerated upon completion of this offering. Please see
Management Director Compensation for
information on options granted to our directors.
26
PRINCIPAL
STOCKHOLDERS
The following table sets forth information as of
November 30, 2006 regarding the number of shares and the
percentage of common stock beneficially owned before and after
the completion of this offering by:
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|
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| |
|
each of our directors and named executive officers listed above
in the summary compensation table; and
|
| |
| |
|
all of our directors and executive officers as a group.
|
We are not aware of any owners of more than 5% of our common
stock other than Messrs. Alimi and Akao and Brookstreet
Securities Corporation. We have determined beneficial ownership
in accordance with the rules of the SEC. Except as indicated by
the footnotes below, we believe, based on the information
furnished to us, that the persons and entities named in the
table below have sole voting and investment power with respect
to all shares of common stock that they beneficially own,
subject to applicable community property laws.
For purposes of the table below, we have 8,399,209 shares
of common stock issued and outstanding prior to the completion
of this offering, assuming the conversion of all outstanding
shares of preferred stock into 4,176,478 shares of common stock,
and 11,476,132 shares of common stock issued and
outstanding upon completion of this offering. In computing the
number of shares of common stock beneficially owned by a person
and the percentage ownership of that person, we deemed
outstanding shares of common stock subject to all derivative
securities held by that person that are currently exercisable or
exercisable within 60 days of November 30, 2006 and
shares of common stock subject to options that vest upon
completion of this offering. We did not deem these shares
outstanding, however, for the purpose of computing the
percentage ownership of any other person.
| |
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|
|
|
|
|
|
|
|
Number of Shares
|
|
|
Percentage of Shares Outstanding
|
|
|
Name of Beneficial
Owner(1)
|
|
Beneficially Owned
|
|
|
Before the Offering
|
|
|
After the Offering
|
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|
|
|
5% Stockholders:
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|
|
|
|
|
|
|
Brookstreet Securities Corporation
and related parties(2)
|
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812,372
|
|
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8.8
|
%
|
|
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6.6
|
%
|
|
Executive Officers and
Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hojabr Alimi(3)
|
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1,439,445
|
|
|
|
16.3
|
%
|
|
|
12.1
|
%
|
|
Robert Miller(4)
|
|
|
195,376
|
|
|
|
2.3
|
%
|
|
|
1.7
|
%
|
|
James Schutz(5)
|
|
|
82,812
|
|
|
|
1.0
|
%
|
|
|
*
|
|
|
Theresa Mitchell(6)
|
|
|
22,656
|
|
|
|
*
|
|
|
|
*
|
|
|
Bruce Thornton(7)
|
|
|
28,322
|
|
|
|
*
|
|
|
|
*
|
|
|
Akihisa Akao(8)
|
|
|
541,320
|
|
|
|
6.4
|
%
|
|
|
4.7
|
%
|
|
Robert Burlingame(9)
|
|
|
216,666
|
|
|
|
2.5
|
%
|
|
|
1.9
|
%
|
|
Edward Brown(10)
|
|
|
50,000
|
|
|
|
*
|
|
|
|
*
|
|
|
Richard Conley(11)
|
|
|
188,820
|
|
|
|
2.2
|
%
|
|
|
1.6
|
%
|
|
Gregory French(12)
|
|
|
75,382
|
|
|
|
*
|
|
|
|
*
|
|
|
All directors and executive
officers as a group (10 persons)(13)
|
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2,840,799
|
|
|
|
29.9
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%
|
|
|
22.6
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%
|
|
|
|
|
* |
|
Represents beneficial ownership of less than 1%. |
| |
|
(1) |
|
Unless otherwise noted, the address of each beneficial owner
listed in the table is: c/o Oculus Innovative Sciences,
Inc., 1129 N. McDowell Boulevard, Petaluma, California
94954. |
| |
|
(2) |
|
Principal address is 2361 Campus Drive, Suite 210, Irvine,
California 92612. Consists of shares issuable under warrants
that are immediately exercisable. Stan Brooks, trustee of the
Brooks Family Trust, has voting or investment power for the
shares held by Brookstreet Securities Corporation. |
27
|
|
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(3) |
|
Includes 422,867 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006 and 7,828 shares issuable upon exercise of options that
will become exercisable upon completion of this offering. |
| |
|
(4) |
|
Includes 75,376 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006, 60,000 shares issuable upon exercise of options to be
granted upon completion of this offering and 50,000 shares
held by The Miller 2005 Grandchildrens Trust, for which
Mr. Miller is a trustee. |
| |
|
(5) |
|
Includes 79,062 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006 and 3,750 shares issuable upon exercise of options
that will become exercisable upon completion of this offering. |
| |
|
(6) |
|
Includes 22,656 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006. |
| |
|
(7) |
|
Includes 28,322 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006. |
| |
|
(8) |
|
Includes 11,078 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006 and 7,828 shares issuable upon exercise of options that
will become exercisable upon completion of this offering. |
| |
|
(9) |
|
Includes 75,000 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006 and 75,000 shares issuable upon exercise of warrants
that are exercisable within 60 days of November 30,
2006. |
| |
|
(10) |
|
Includes 10,000 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006, and 40,000 shares issued upon exercise of options
that will become exercisable upon completion of this offering. |
| |
|
(11) |
|
Includes 140,992 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006 and 7,828 shares issuable upon exercise of options
that will become exercisable upon completion of this offering. |
| |
|
(12) |
|
Includes 31,890 shares issuable upon exercise of options
that are exercisable within 60 days of November 30,
2006, 7,828 shares issuable upon exercise of options that
will become exercisable upon completion of this offering, and
18,750 shares held by the French Living Trust
UTA 4/10/96. |
| |
|
(13) |
|
Includes 972,243 shares issuable upon exercise of options
and warrants that are exercisable within 60 days of
November 30, 2006 and 135,062 shares issuable upon
exercise of options that will become exercisable upon completion
of this offering. |
28
SHARES
ELIGIBLE FOR FUTURE SALE
Lock-Up
Agreements
Our directors and executive officers and certain of our other
stockholders, option holders and warrant holders who
collectively hold at least 90% of our outstanding common stock,
in the aggregate and on a fully diluted basis, are subject to
restrictions on transfer or have, or will have, agreed that they
will not sell, offer, contract or grant any option to sell,
pledge, transfer, establish an open put equivalent position or
otherwise dispose of, any shares of our common stock, securities
convertible into or exercisable or exchangeable for shares of
our common stock or any interest therein, or any capital stock
of our subsidiaries for a period of at least 180 days after
the date of this prospectus. Roth Capital Partners may in its
sole discretion, and subject to certain limited exceptions, at
any time and without notice, release for sale in the public
market all or any portion of the shares subject to the
lock-up
agreements to which it is a party. To the extent shares are
released before the expiration of the
lock-up
period and these shares are sold into the market, the market
price of our common stock could decline. As a result of the
transfer restrictions and
lock-up
agreements described above and the provisions of Rules 144,
144(k) and 701, the restricted shares will be available for sale
in the public market as follows:
229,025 shares will be eligible for sale immediately
following the date of this prospectus;
7,976,604 shares will be eligible for sale upon the
expiration of the
lock-up
agreements, described above, beginning 180 days after the
date of this prospectus; and
193,580 shares will be eligible for sale upon the
exercise of vested options, beginning 180 days after the
date of this prospectus.
UNDERWRITING
Subject to the terms and conditions of the underwriting
agreement among us and the underwriters, each underwriter has
agreed to purchase from us the following respective number of
shares of common stock at the offering price less the
underwriting discount set forth on the cover page of this
prospectus.
| |
|
|
|
|
|
Underwriter
|
|
Shares
|
|
|
|
Roth Capital Partners
|
|
|
|
|
|
Brookstreet Securities Corporation
|
|
|
|
|
|
Maxim Group LLC
|
|
|
|
|
|
Total
|
|
|
|
|
The underwriting agreement provides that the obligations of the
underwriters are subject to certain conditions precedent and
that the underwriters will purchase all such shares of common
stock if any of these shares are purchased. The underwriters are
obligated to take and pay for all of the shares of common stock
offered hereby, other than those covered by the over-allotment
option described below, if any are taken.
The underwriters have advised us that they propose to offer the
shares of common stock to the public at the offering price set
forth on the cover page of this prospectus and to certain
dealers at such price less a concession not in excess of
$ per share. The underwriters
may allow, and such dealers may re-allow, a concession not in
excess of $ per share to
certain other dealers. If all of the shares are not sold at the
initial offering price, the underwriters may change the offering
price and other selling terms.
Pursuant to the underwriting agreement, we have granted to the
underwriters an option, exercisable for 30 days after the
date of this prospectus, to purchase up to an aggregate of
461,539 additional shares of common stock from us, at the
offering price, less the underwriting discount set forth on the
cover page of this prospectus, solely to cover over-allotments.
To the extent that the underwriters exercise such option, the
underwriters will become obligated, subject to certain
conditions, to purchase approximately the same percentage of
such additional shares as the number
29
set forth next to the underwriters name in the preceding
table bears to the total number of shares in the table, and we
will be obligated, pursuant to the option, to sell such shares
to the underwriters.
The following table summarizes the discounts and commissions to
be paid to the underwriters by us in connection with this
offering. These amounts are shown assuming both no exercise and
full exercise of the underwriters option to purchase
additional shares of common stock.
| |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
No Exercise
|
|
|
Full Exercise
|
|
|
|
|
Per Share
|
|
$
|
|
|
|
$
|
|
|
|
Total
|
|
$
|
|
|
|
$
|
|
|
We expect to incur expenses, exclusive of the underwriting
discount and commission, of approximately $3.2 million in
connection with this offering. We have agreed to pay to Roth
Capital Partners and Brookstreet Securities Corporation a
non-accountable expense allowance equal to 1% of the gross
proceeds to us in the offering. An electronic prospectus is
available on the websites maintained by the underwriters and may
also be made available on websites maintained by selected
dealers and selling group members participating in this
offering. No form of prospectus other than print and electronic
forms, which will be printable, will be used in connection with
this offering.
In connection with the offering, we have agreed to sell to the
underwriters, for nominal consideration, underwriter warrants
entitling the underwriters, or their assigns, to purchase up to
an aggregate of 7% of the total number of shares sold in this
offering at a price equal to 165% of the public offering price
per share. The underwriter warrants will be exercisable for five
years from the closing date of the offering and will contain
cashless exercise provisions and customary anti-dilution
provisions. The underwriter warrants grant the underwriters, or
their assigns, piggyback registration rights with
respect to the common stock issuable upon exercise of the
underwriter warrants for the five-year period during which the
underwriter warrants are exercisable.
In addition, within 180 days prior to the effective date of
this offering, we have issued to Brookstreet Securities
Corporation warrants to purchase an aggregate of
24,127 shares of our common stock, at an exercise price of
$18.00 per share, for its services as the managing dealer
in connection with our Series C Financing and warrants to
purchase 25,000 shares of our common stock, at an exercise
price of $18.00 per share, for its services as a finder in
connection with our Bridge Loan.
The underwriter warrants and the warrants issued to Brookstreet
in connection with our Series C Financing and Bridge Loan
are deemed compensation by the National Association of
Securities Dealers, or NASD, and may not be sold, transferred,
pledged, hypothecated or assigned for a period of
180-days
following the effective date of the offering pursuant to
Rule 2710(g)(1) of the NASD Conduct Rules.
We, our directors and executive officers and certain of our
other stockholders, option holders and warrant holders are
subject to certain restrictions on transfer or have, or will
have, agreed that during the
180-day
period after the date of this prospectus, subject to limited
exceptions, we and they will not, without prior written consent
from Roth Capital Partners, directly or indirectly, issue, sell,
offer, agree to sell, grant any option or contract for the sale
of, pledge, make any short sale of, maintain any short position
with respect to, establish or maintain a put equivalent
option (within the meaning of
Rule 16a-1(h)
under the Exchange Act) with respect to, enter into any swap,
derivative transaction or other arrangement (whether any such
transaction is to be settled by delivery of common stock, other
securities, cash or other consideration) that transfers to
another, in whole or in part, any of the economic consequences
of ownership, or otherwise dispose of, any shares of our common
stock, or any securities convertible into, exercisable or
exchangeable for, our common stock or any interest therein or
any capital stock of our subsidiaries). These transfer
restrictions and
lock-up
agreements will cover approximately 90% of our outstanding
common stock in the aggregate and on a fully-diluted basis. Roth
Capital Partners may, in its sole discretion and subject to
certain limited exceptions, allow any party subject to the
lock-up agreements to which it is a party to dispose of common
stock or other
30
securities prior to the expiration of the
180-day
period; no agreements between Roth Capital Partners and the
parties allow them to do so as of the date of this prospectus.
The 180-day
restricted period contained in the
lock-up
agreements described above is subject to extension such that, in
the event that either (1) during the last 17 days of
the 180-day period, we issue an earnings release or material
news or a material event relating to us occurs or (2) prior
to the expiration of the
180-day
restricted period, we announce that we will release earnings
results during the
16-day
period beginning on the last day of the
180-day
period, the lock-up restrictions described above
will, subject to limited exceptions, continue to apply until the
date that is 15 calendar days plus three business days
after the date of issuance of the earnings release or the
occurrence of the material news or material event.
Prior to the offering, there has been no public market for the
common stock. The initial public offering price for the shares
of common stock included in this offering will be determined by
negotiation among us and Roth Capital Partners. Among the
factors considered in determining the price were:
|
|
|
| |
|
the history of and prospects for our business and the industry
in which we operate;
|
| |
| |
|
an assessment of our management;
|
| |
| |
|
our past and present revenues and earnings;
|
| |
| |
|
the prospects for growth of our revenues and earnings; and
|
| |
| |
|
currently prevailing conditions in the securities markets,
including current market valuations of publicly traded companies
which are comparable to us.
|
Each of the underwriters has advised us that it does not intend
to confirm sales to any account over which it exercises
discretionary authority.
We have agreed to indemnify the underwriters against certain
liabilities, including liabilities under the Securities Act.
Until the distribution of the common stock is completed, rules
of the Commission may limit the ability of the underwriters and
certain selling group members to bid for and purchase the common
stock. As an exception to these rules, the underwriters are
permitted to engage in certain transactions that stabilize,
maintain or otherwise affect the price of the common stock.
In connection with this offering, the underwriters may engage in
stabilizing transactions, over-allotment transactions, syndicate
covering transactions and penalty bids in accordance with
Regulation M under the Exchange Act.
|
|
|
| |
|
Stabilizing transactions permit bids to purchase the underlying
security so long as the stabilizing bids do not exceed a
specified maximum.
|
| |
| |
|
Over-allotment transactions involve sales by the underwriters of
the shares of common stock in excess of the number of shares the
underwriters are obligated to purchase, which creates a
syndicate short position. The short position may be either a
covered short position or a naked short position. In a covered
short position, the number of shares over-allotted by the
underwriters is not greater than the number of shares they may
purchase in the over-allotment option. In a naked short
position, the number of shares involved is greater than the
number of shares in the over-allotment. The underwriters may
close out any short position by exercising their over-allotment
option
and/or
purchasing shares of common stock in the open market.
|
| |
| |
|
Syndicate covering transactions involve purchases of the shares
of common stock in the open market after the distribution has
been completed in order to cover syndicate short positions. In
determining the source of the shares of common stock to close
out the short position, the underwriters will consider, among
other things, the price of shares of common stock available for
purchase in the open market as compared to the price at which
they may purchase shares of common stock through the
over-allotment option. If the underwriters sell more shares of
common stock than could be covered by the over-
|
31
|
|
|
| |
|
allotment option, a naked short position, the position can only
be closed out by buying shares of common stock in the open
market. A naked short position is more likely to be created if
the underwriters are concerned that there could be downward
pressure on the price of the shares of common stock in the open
market after pricing that could adversely affect investors who
purchase in the offering.
|
|
|
|
| |
|
Penalty bids permit representatives to reclaim a selling
concession from a syndicate member when the shares of common
stock originally sold by the syndicate member are purchased in a
stabilizing or syndicate covering transaction to cover syndicate
short positions.
|
Similar to other purchase transactions, the underwriters
purchases to cover the syndicate short sales may have the effect
of raising or maintaining the market price of the shares of
common stock or preventing or retarding a decline in the market
price of the shares of common stock. As a result, the price of
the shares of common stock may be higher than the price that
might otherwise exist in the open market.
The underwriters will deliver a prospectus to all purchasers of
shares of common stock in the short sales. The purchases of
shares of common stock in short sales are entitled to the same
remedies under the federal securities laws as any other
purchaser of shares of common stock covered by this prospectus.
Passive market making may stabilize or maintain the market price
of our common stock at a level above that which might otherwise
prevail and, if commenced, may be discontinued at any time.
The underwriters are not obligated to engage in any of the
transactions described above. If they do engage in any of these
transactions, they may discontinue them at any time.
We have applied to list the common stock on the Nasdaq Global
Market under the symbol OCLS.
From time to time in the ordinary course of their respective
businesses, the underwriters and their affiliates may in the
future engage in commercial banking or investment banking
transactions with our affiliates and us.
Selling
Restrictions
The distribution of this document and the offering and sale of
shares in certain non-US jurisdictions may be restricted by law
and therefore persons into whose possession this document comes
should inform themselves about and observe any such
restrictions. Any failure to comply with these restrictions may
constitute a violation of securities law of any such
jurisdiction.
Purchasers of the shares offered by this prospectus may be
required to pay stamp taxes and other charges in accordance with
the laws and practices of the country of purchase in addition to
the offering price on the cover page of this prospectus.
32
OCULUS
INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(INFORMATION AS OF SEPTEMBER 30, 2006 AND FOR THE SIX
MONTHS ENDED
SEPTEMBER 30, 2005 AND 2006 IS UNAUDITED)
NOTE 1
The Company
Oculus Innovative Sciences, Inc. (the Company) was
incorporated under the laws of the State of California in April
1999. The Companys principal office is located in
Petaluma, California. The Company has developed and manufactures
and markets a family of products intended to help prevent and
treat infection in acute and chronic wounds. The Companys
platform technology, Microcyn, is an electrically charged, or
super-oxidized, water-based solution that is designed to treat a
wide range of pathogens, including viruses, fungi, spores and
antibiotic resistant strains of bacteria, such as MRSA and VRE,
in wounds. The Company conducts its business world-wide, with
its principal subsidiaries in Europe and Mexico.
As discussed in Note 2, the Companys amended articles
of incorporation were amended on August 28, 2006,
authorizing it to issue up to 875,000 of Series C
convertible preferred stock.
NOTE 11
Commitments, Contingencies and Other Matters
Legal
Matters
In September 2006, a consulting firm in Mexico City contacted
the Company threatening legal action in Mexico, alleging breach
of contract and claiming damages of $225,000. A formal compliant
has not been served and no trial date has been set. In December
2006, the Company entered into a settlement agreement with the
consulting firm where the Company paid $115,000 for the
dismissal of their claim and waiver of any previous claims
against the Company.
Proposed
Initial Public Offering
On September 1, 2005 the Board of Directors authorized the
Company to file a registration statement with the SEC in
connection with its proposed IPO. The Company incurred $478,000
of costs during the year ended March 31, 2006 and $731,000
of costs in the six months ended September 30, 2006 in
connection with its proposed IPO, which amounts are presented as
deferred offering costs in the accompanying balance sheet at
March 31, 2006 and September 30, 2006.
The Company expects to receive net proceeds of approximately
$34.0 million from this offering, based on an assumed
initial public offering price of $13.00 per share, after
deducting the underwriting discount and estimated offering
expenses. If the underwriters exercise their over-allotment
option in full, our estimated net proceeds will be approximately
$39.6 million.
The Company currently intends to use the proceeds of this
offering as follows: approximately $12.6 million will be
used to expand sales and marketing capabilities, including the
expansion of a direct sales force in the U.S. and Europe,
approximately $13.0 million will be used to fund clinical
trials and related research, approximately $1.5 million to
repay the principal and interest on the $4.0 million Bridge
Loan (that will be repaid in its entirety as described in
Note 18) and the remaining proceeds are to be used for
general corporate purposes, including working capital.
The Company cannot provide any assurance that it will complete
its proposed IPO. The Company expects to incur substantial
additional costs in connection with its efforts to complete this
offering. If the Company completes its IPO, these costs will be
recorded as a reduction of the proceeds received. If the Company
does not successfully complete its IPO, the costs will be
recorded as a charge to operations.
NOTE 16
Segment and Geographic Information
In accordance with SFAS No. 131, Disclosures
About Segments of an Enterprise and Related Information
(SFAS 131), operating segments are identified
as components of an enterprise for which separate and
33
OCULUS
INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
(INFORMATION AS OF SEPTEMBER 30, 2006 AND FOR THE SIX
MONTHS ENDED
SEPTEMBER 30, 2005 AND 2006 IS UNAUDITED)
discreet financial information is available and is used by the
chief operating decision maker, or decision-making group, in
making decisions on how to allocate resources and assess
performance. The Companys chief decision-makers, as
defined by SFAS 131, are the Chief Executive Officer and
his direct reports.
The Companys chief decision-makers review financial
information presented on a consolidated basis, accompanied by
disaggregated information about revenue and operating profit by
operating unit. This information is used for purposes of
allocating resources and evaluating financial performance.
The accounting policies of the segments are the same as those
described in the Summary of Significant Accounting
Policies. Segment data includes segment revenue, segment
operating profitability, and total assets by segment. Shared
corporate operating expenses are reported in the
U.S. segment.
The Company is organized primarily on the basis of operating
units which are segregated by geography.
The following tables present information about reportable
segments (in thousands):
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
Europe
|
|
|
Mexico
|
|
|
Total
|
|
|
|
|
Year ended March 31,
2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues
|
|
$
|
|
|
|
$
|
|
|
|
$
|
95
|
|
|
$
|
95
|
|
|
Service revenues
|
|
|
807
|
|
|
|
|
|
|
|
|
|
|
|
807
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
807
|
|
|
|
|
|
|
|
95
|
|
|
|
902
|
|
|
Depreciation expense
|
|
|
159
|
|
|
|
2
|
|
|
|
2
|
|
|
|
163
|
|
|
Operating loss
|
|
|
(4,914
|
)
|
|
|
(209
|
)
|
|
|
(1,974
|
)
|
|
|
(7,097
|
)
|
|
Interest expense
|
|
|
(178
|
)
|
|
|
|
|
|
|
|
|
|
|
(178
|
)
|
|
Interest income
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
|
Total assets
|
|
|
2,150
|
|
|
|
245
|
|
|
|
597
|
|
|
|
2,992
|
|
|
Year ended March 31,
2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues
|
|
$
|
4
|
|
|
$
|
35
|
|
|
$
|
434
|
|
|
$
|
473
|
|
|
Service revenues
|
|
|
883
|
|
|
|
|
|
|
|
|
|
|
|
883
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
887
|
|
|
|
35
|
|
|
|
434
|
|
|
|
1,356
|
|
|
Depreciation expense
|
|
|
368
|
|
|
|
49
|
|
|
|
17
|
|
|
|
434
|
|
|
Operating loss
|
|
|
(12,242
|
)
|
|
|
(1,529
|
)
|
|
|
(2,541
|
)
|
|
|
(16,312
|
)
|
|
Interest expense
|
|
|
(372
|
)
|
|
|
|
|
|
|
|
|
|
|
(372
|
)
|
|
Interest income
|
|
|
8
|
|
|
|
|
|
|
|
|
|
|
|
8
|
|
|
Total assets
|
|
|
5,017
|
|
|
|
858
|
|
|
|
1,065
|
|
|
|
6,940
|
|
|
Year ended March 31,
2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues
|
|
$
|
109
|
|
|
$
|
69
|
|
|
$
|
1,788
|
|
|
$
|
1,966
|
|
|
Service revenues
|
|
|
618
|
|
|
|
|
|
|
|
|
|
|
|
618
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
727
|
|
|
|
69
|
|
|
|
1,788
|
|
|
|
2,584
|
|
|
Depreciation expense
|
|
|
463
|
|
|
|
96
|
|
|
|
92
|
|
|
|
651
|
|
|
Operating loss
|
|
|
(12,621
|
)
|
|
|
(2,685
|
)
|
|
|
(5,545
|
)
|
|
|
(20,851
|
)
|
|
Interest expense
|
|
|
(172
|
)
|
|
|
|
|
|
|
|
|
|
|
(172
|
)
|
|
Interest income
|
|
|
282
|
|
|
|
|
|
|
|
|
|
|
|
282
|
|
|
Total assets
|
|
|
8,977
|
|
|
|
1,652
|
|
|
|
2,060
|
|
|
|
12,689
|
|
34
OCULUS
INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Concluded)
(INFORMATION AS OF SEPTEMBER 30, 2006 AND FOR THE SIX
MONTHS ENDED
SEPTEMBER 30, 2005 AND 2006 IS UNAUDITED)
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
Europe
|
|
|
Mexico
|
|
|
Total
|
|
|
|
|
Six months ended
September 30, 2005 (unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues
|
|
$
|
88
|
|
|
$
|
64
|
|
|
$
|
655
|
|
|
$
|
807
|
|
|
Service revenues
|
|
|
275
|
|
|
|
|
|
|
|
|
|
|
|
275
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
363
|
|
|
|
64
|
|
|
|
655
|
|
|
|
1,082
|
|
|
Depreciation expense
|
|
|
227
|
|
|
|
42
|
|
|
|
39
|
|
|
|
307
|
|
|
Operating loss
|
|
|
(5,518
|
)
|
|
|
(913
|
)
|
|
|
(3,003
|
)
|
|
|
(9,434
|
)
|
|
Interest expense
|
|
|
(103
|
)
|
|
|
|
|
|
|
|
|
|
|
(103
|
)
|
|
Interest income
|
|
|
68
|
|
|
|
|
|
|
|
|
|
|
|
68
|
|
|
Total assets
|
|
|
19,069
|
|
|
|
1,187
|
|
|
|
7,098
|
|
|
|
27,354
|
|
|
Six months ended
September 30, 2006 (unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues
|
|
$
|
56
|
|
|
$
|
828
|
|
|
$
|
1,058
|
|
|
$
|
1,942
|
|
|
Service revenues
|
|
|
388
|
|
|
|
|
|
|
|
|
|
|
|
388
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
444
|
|
|
|
828
|
|
|
|
1,058
|
|
|
|
2,330
|
|
|
Depreciation expense
|
|
|
190
|
|
|
|
92
|
|
|
|
46
|
|
|
|
328
|
|
|
Operating loss
|
|
|
(5,715
|
)
|
|
|
(1,053
|
)
|
|
|
(1,829
|
)
|
|
|
(8,597
|
)
|
|
Interest expense
|
|
|
(261
|
)
|
|
|
|
|
|
|
|
|
|
|
(261
|
)
|
|
Interest income
|
|
|
100
|
|
|
|
|
|
|
|
|
|
|
|
100
|
|
|
Total assets
|
|
|
5,172
|
|
|
|
2,514
|
|
|
|
2,370
|
|
|
|
10,056
|
|
For the six months ended September 30, 2006, the Company
recorded $580,000 of sales to customers in India. These sales
are reported as part of the Europe segment.
NOTE 18
Subsequent Events
Settlement
Agreement
In November 2006, the Company entered into a settlement
agreement with a former director and chief operating officer.
The settlement agreement provides for a $250,000 cash payment,
which is subject to the Company closing equity financing with
gross proceeds of $10 million or more, or its initial
public offering. In addition, the plaintiff will be provided a
warrant to purchase 50,000 shares of the Companys
common stock at an exercise price of $3.00 per share. Issuance
of the warrant is subject to the waiver of any applicable rights
by the holders of the Companys preferred stock under the
Companys Amended and Restated Investors Rights Agreement.
On December 14, 2006, the Companys preferred
stockholders voted to waive the applicable rights allowing the
Company to issue the warrants. The Company previously reserved
for this litigation and the expense will be recorded as a
general and administrative expense in the period the warrants
are approved and issued (Note 11).
Board
Nomination
On November 7, 2006, the Board of Directors appointed an
individual to fill the vacant Series A board seat. Pursuant
to the terms of the Director Agreement, the Company will issue
the individual an option to purchase 75,000 shares of the
Companys common stock at $13.00 per share. The
options vest immediately and are exercisable for a period of
five years. On December 14, 2006 the Series A
stockholders approved the appointment of this individual to the
Companys Board of Directors.
35