10-Q: Quarterly report pursuant to Section 13 or 15(d)
Published on May 14, 2008
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
For
the
quarterly period ended March 31, 2008.
OR
o TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
For
the
transition period from ________ to ________.
Commission
file number 000-27748
OPKO
Health, Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
|
75-2402409
|
|
(State
or other jurisdiction of
incorporation
or organization)
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(I.R.S.
Employer Identification No.)
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4400
Biscayne Blvd., Suite 1180
Miami,
FL
33137
(Address
of Principal Executive Offices)
(305) 575-4138
(Registrant’s
Telephone Number, Including Area Code)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. YES o NO x
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” (as defined in Rule 12b-2 of the Exchange Act).
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer x
(Do not check if a smaller reporting company)
|
Smaller
reporting company o
|
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act): YES
o
NO
x
1
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Page(s)
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PART
I. FINANCIAL INFORMATION
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Item 1.
Financial Statements:
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Condensed
Consolidated Balance Sheets as of March 31, 2008 and December 31,
2007
(unaudited)
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5
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Condensed
Consolidated Statements of Operations for the three months ended
March 31,
2008 and March 31, 2007 (unaudited)
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6
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Condensed
Consolidated Statements of Cash Flows for the three months ended
March 31,
2008 and March 31, 2007 (unaudited)
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7
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Notes
to Financial Statements
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8
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Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of
Operations
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13
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Item 3.
Quantitative and Qualitative Disclosures About Market Risk
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17
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Item 4T.
Controls and Procedures
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17
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PART
II. OTHER INFORMATION
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17
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Item 1A.
Risk Factors
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18
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Item 2.
Unregistered Sales of Equity Securities and Use of
Proceeds
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18
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Item 3.
Defaults Upon Senior Securities
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18
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Item 4.
Submission of Matters to a Vote of Security Holders
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18
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Item 5.
Other Information
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18
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Item 6.
Exhibits
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19
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Signatures
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19
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Exhibit Index
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EX-31.1
Section 302 Certification of CEO
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EX-31.2
Section 302 Certification of CFO
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EX-32.1
Section 906 Certification of CEO
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EX-32.2
Section 906 Certification of CFO
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2
PART
I. FINANCIAL INFORMATION
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This
report contains “forward-looking statements,” as that term is defined under the
Private Securities Reform Litigation Act of 1995, or PSLRA, Section 27A of
the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. Forward-looking statements include statements about
our
expectations, beliefs or intentions regarding our product development efforts,
business, financial condition, results of operations, strategies or prospects.
You can identify forward-looking statements by the fact that these statements
do
not relate strictly to historical or current matters. Rather, forward-looking
statements relate to anticipated or expected events, activities, trends or
results as of the date they are made. Because forward-looking statements relate
to matters that have not yet occurred, these statements are inherently subject
to risks and uncertainties that could cause our actual results to differ
materially from any future results expressed or implied by the forward-looking
statements. Many factors could cause our actual activities or results to differ
materially from the activities and results anticipated in forward-looking
statements. These factors include those described below and in “Item 1A-Risk
Factors” of our Annual Report on Form 10-K for the year ended December 31, 2007
and described from time to time in our reports filed with the Securities and
Exchange Commission. We do not undertake any obligation to update
forward-looking statements. We intend that all forward-looking statements be
subject to the safe-harbor provisions of the PSLRA. These forward-looking
statements are only predictions and reflect our views as of the date they are
made with respect to future events and financial performance.
Risks
and
uncertainties, the occurrence of which could adversely affect our business,
include the following:
·
|
We
have a history of operating losses and we do not expect to become
profitable in the near future.
|
·
|
Our
technologies are in an early stage of development and are
unproven.
|
·
|
Our
drug research and development activities may not result in commercially
viable products.
|
·
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We
are highly dependent on the success of our lead product candidate,
bevasiranib, and we cannot give any assurance that it will receive
regulatory approval or be successfully
commercialized.
|
·
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The
results of previous clinical trials may not be predictive of future
results, and our current and planned clinical trials may not satisfy
the
requirements of the FDA or other non-United States regulatory authorities.
|
·
|
We
will require substantial additional funding, which may not be available
to
us on acceptable terms, or at all.
|
·
|
If
our competitors develop and market products that are more effective,
safer
or less expensive than our future product candidates, our commercial
opportunities will be negatively
impacted.
|
·
|
The
regulatory approval process is expensive, time consuming and uncertain
and
may prevent us or our collaboration partners from obtaining approvals
for
the commercialization of some or all of our product
candidates.
|
·
|
Failure
to recruit and enroll patients for clinical trials may cause the
development of our product candidates to be
delayed.
|
·
|
Even
if we obtain regulatory approvals for our product candidates, the
terms of
approvals and ongoing regulation of our products may limit how we
manufacture and market our product candidates, which could materially
impair our ability to generate anticipated
revenues.
|
·
|
We
may not meet regulatory quality standards applicable to our manufacturing
and quality processes.
|
·
|
We
may be unable to resolve issues relating to an FDA warning letter
in a
timely manner.
|
·
|
Even
if we receive regulatory approval to market our product candidates,
the
market may not be receptive to our
products.
|
·
|
If
we fail to attract and retain key management and scientific personnel,
we
may be unable to successfully develop or commercialize our product
candidates.
|
·
|
As
we evolve from a company primarily involved in development to a company
also involved in commercialization, we may encounter difficulties
in
managing our growth and expanding our operations
successfully.
|
·
|
If
we fail to acquire and develop other products or product candidates
at all
or on commercially reasonable terms, we may be unable to diversify
or grow
our business.
|
3
·
|
We
have no experience manufacturing our pharmaceutical product candidates
and
we therefore rely on third parties to manufacture and supply our
pharmaceutical product candidates, and would need to meet various
standards necessary to satisfy FDA regulations when we commence
manufacturing.
|
·
|
We
currently have no pharmaceutical marketing, sales or distribution
organization. If we are unable to develop our sales and marketing
and
distribution capability on our own or through collaborations with
marketing partners, we will not be successful in commercializing
our
pharmaceutical product candidates.
|
·
|
Independent
clinical investigators and contract research organizations that we
engage
to conduct our clinical trials may not be diligent, careful or
timely.
|
·
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The
success of our business may be dependent on the actions of our
collaborative partners.
|
·
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If
we are unable to obtain and enforce patent protection for our products,
our business could be materially
harmed.
|
·
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If
we are unable to protect the confidentiality of our proprietary
information and know-how, the value of our technology and products
could
be adversely affected.
|
·
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We
rely heavily on licenses from third
parties.
|
·
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We
license patent rights to certain of our technology from third-party
owners. If such owners do not properly maintain or enforce the patents
underlying such licenses, our competitive position and business prospects
will be harmed.
|
·
|
Our
commercial success depends significantly on our ability to operate
without
infringing the patents and other proprietary rights of third
parties.
|
·
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Medicare
prescription drug coverage legislation and future legislative or
regulatory reform of the health care system may affect our ability
to sell
our products profitably.
|
·
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Failure
to obtain regulatory approval outside the United States will prevent
us
from marketing our product candidates
abroad.
|
·
|
Acquisitions
may disrupt our business, distract our management and may not proceed
as
planned; and we may encounter difficulties in integrating acquired
businesses.
|
·
|
Non-United
States governments often impose strict price controls, which may
adversely
affect our future profitability.
|
·
|
Our
business may become subject to economic, political, regulatory and
other
risks associated with international
operations.
|
·
|
The
market price of our common stock may fluctuate
significantly.
|
·
|
Directors,
executive officers, principal stockholders and affiliated entities
own a
significant percentage of our capital stock, and they may make decisions
that you do not consider to be in your best interests or in the best
interests of our other
stockholders.
|
·
|
Compliance
with changing regulations concerning corporate governance and public
disclosure may result in additional
expenses.
|
·
|
If
we are unable to satisfy the requirements of Section 404 of the
Sarbanes-Oxley Act of 2002, as they apply to us, or our internal
controls
over financial reporting are not effective, the reliability of our
financial statements may be questioned and our common stock price
may
suffer.
|
·
|
We
may be unable to maintain our listing on the American Stock Exchange,
which could cause our stock price to fall and decrease the liquidity
of
our common stock.
|
·
|
Future
issuances of common stock and hedging activities may depress the
trading
price of our common stock.
|
·
|
Provisions
in our charter documents and Delaware law could discourage an acquisition
of us by a third party, even if the acquisition would be favorable
to
you.
|
·
|
We
do not intend to pay cash dividends on our common stock in the foreseeable
future.
|
Unless
the context otherwise requires, all references in this Quarterly Report on
Form
10-Q to the “Company”, “OPKO”, “we”, “our”, “ours”, and “us” refers to OPKO
Health, Inc., a Delaware corporation, including our wholly-owned
subsidiaries.
4
CONDENSED
CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands except share data)
|
March
31, 2008
|
December
31, 2007
|
|||||
ASSETS
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
14,644
|
$
|
23,373
|
|||
Accounts
receivable, net
|
1,731
|
1,689
|
|||||
Inventory
|
2,507
|
2,214
|
|||||
Prepaid
expenses and other current assets
|
1,699
|
1,936
|
|||||
Total
current assets
|
20,581
|
29,212
|
|||||
Property
and equipment, net
|
419
|
410
|
|||||
Intangible
assets, net
|
9,789
|
9,931
|
|||||
Other
assets
|
36
|
15
|
|||||
Total
assets
|
$
|
30,825
|
$
|
39,568
|
|||
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable
|
$
|
2,722
|
$
|
3,319
|
|||
Accrued
expenses
|
5,599
|
3,858
|
|||||
Capital
lease obligations and current portion of note payable, net unamortized
discount of $0 and $8, respectively
|
282
|
2,546
|
|||||
Total
current liabilities
|
8,603
|
9,723
|
|||||
Long-term
liabilities and capital lease obligations
|
1,683
|
1,372
|
|||||
Line
of credit with related party, net unamortized discount of $267
and
$311, respectively
|
11,738
|
11,689
|
|||||
Total
liabilities
|
22,024
|
22,784
|
|||||
Commitments
and contingencies
|
|||||||
Shareholders’ equity
|
|||||||
Series
A Preferred stock - $0.01 par value, 4,000,000 shares authorized;
876,954
and 954,799 shares issued and outstanding (liquidation value of $2,247
and
$2,387) at March, 31, 2008 and December 31, 2007,
respectively
|
9
|
10
|
|||||
Series
C Preferred Stock - $0.01 par value, 500,000 shares authorized; no
shares
issued or outstanding
|
-
|
-
|
|||||
Common
Stock - $0.01 par value, 500,000,000 shares authorized; 182,627,028
and
178,344,608 shares issued and outstanding at March 31, 2008 and December
31, 2007, respectively
|
1,826
|
1,783
|
|||||
Additional
paid-in-capital
|
287,128
|
284,273
|
|||||
Accumulated
deficit
|
(280,162
|
)
|
(269,282
|
)
|
|||
Total
shareholders’ equity
|
8,801
|
16,784
|
|||||
Total
liabilities and shareholders’ equity
|
$
|
30,825
|
$
|
39,568
|
The
accompanying Notes to Condensed Consolidated Financial Statements are an
integral part of these statements.
5
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in
thousands, except share data)
|
The
three months ended
March
31,
|
||||||
2008
|
2007
|
||||||
Revenue
|
$
|
2,824
|
$
|
-
|
|||
Cost
of goods sold
|
3,330
|
-
|
|||||
Gross
margin (deficit)
|
(506
|
)
|
-
|
||||
|
|||||||
Operating
expenses
|
|||||||
Selling,
general and administrative
|
5,344
|
90
|
|||||
Research
and development
|
4,356
|
6,072
|
|||||
Write-off
of acquired in-process research and development
|
-
|
243,761
|
|||||
Other
operating expenses, principally amortization of intangible
assets
|
426
|
-
|
|||||
Total
operating expenses
|
10,126
|
249,923
|
|||||
Operating
loss
|
(10,632
|
)
|
(249,923
|
)
|
|||
Other
(expense) income, net
|
(269
|
)
|
(12
|
)
|
|||
Loss
before income taxes
|
(10,901
|
)
|
(249,935
|
)
|
|||
Income
tax benefit
|
(21
|
)
|
-
|
||||
Net
loss
|
(10,880
|
)
|
(249,935
|
)
|
|||
Preferred
stock dividend
|
(55
|
)
|
(10
|
)
|
|||
Net
loss attributable to common shareholders
|
$
|
(10,935
|
)
|
$
|
(249,945
|
)
|
|
|
|||||||
Loss
per share, basic and diluted
|
$
|
(0.06
|
)
|
$
|
(3.87
|
)
|
|
|
|||||||
Weighted
average number of shares outstanding, basic and diluted
|
180,572,915
|
64,623,855
|
The
accompanying Notes to Condensed Consolidated Financial Statements are an
integral part of these statements.
6
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in
thousands)
For
the three months ended
March
31,
|
|||||||
2008
|
2007
|
||||||
Cash
flows from operating activities
|
|
|
|||||
Net
loss
|
$
|
(10,880
|
)
|
$
|
(249,935
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
452
|
1
|
|||||
Write-off
of acquired in-process research and development
|
-
|
243,761
|
|||||
Accretion
of debt discount related to notes payable
|
56
|
4
|
|||||
Stock
based compensation - employees and non-employees
|
2,731
|
6,035
|
|||||
Changes
in:
|
|||||||
Accounts
receivable, net
|
(42
|
)
|
-
|
||||
Inventory
|
(293
|
)
|
-
|
||||
Prepaid
expenses and other current assets
|
237
|
210
|
|||||
Other
assets
|
(21 |
)
|
-
|
||||
Accounts
payable
|
(597
|
)
|
(381
|
)
|
|||
Accrued
expenses and long-term liabilities
|
1,797
|
(155
|
)
|
||||
Net
cash (used in) provided by operating activities
|
(6,560
|
)
|
(460
|
)
|
|||
Cash
flows from investing activities
|
|||||||
Acquisition
of businesses, net of cash
|
-
|
1,135
|
|||||
Capital
expenditures
|
(32
|
)
|
-
|
||||
Net
cash used in investing activities
|
(32
|
)
|
1,135
|
||||
Cash
flows from financing activities:
|
|||||||
Issuance
of common stock
|
-
|
16,284
|
|||||
Insurance
financing
|
190
|
-
|
|||||
Proceeds
from the exercise of stock options and warrants
|
168
|
-
|
|||||
Repayments
of notes payable and capital lease obligations
|
(2,495
|
)
|
-
|
||||
Net
cash (used in) provided by financing activities
|
(2,137
|
)
|
16,284
|
||||
Net (decrease)
increase in cash and cash equivalents
|
(8,729
|
)
|
16,959
|
||||
Cash
and cash equivalents at beginning of period
|
23,373
|
116
|
|||||
Cash
and cash equivalents at end of period
|
$
|
14,644
|
$
|
17,075
|
|||
SUPPLEMENTAL
INFORMATION
|
|||||||
Interest
paid
|
$
|
95
|
$
|
41
|
|||
NON-CASH
FINANCING
|
|||||||
Issuance
of Capital Stock to acquire Acuity
|
$
|
-
|
$
|
243,623
|
The
accompanying Notes to Condensed Consolidated Financial Statements are an
integral part of these statements.
7
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
NOTE
1 BUSINESS AND ORGANZIATION
We
are a
specialty healthcare company focused on the discovery, development, and
commercialization of proprietary pharmaceuticals, imaging and diagnostic
systems, and instruments for the treatment, diagnosis, and management of
ophthalmic disorders. Our business presently consists of the development of
ophthalmic pharmaceuticals and the development, commercialization and sale
of
ophthalmic diagnostic and imaging systems and instrumentation products. Our
objective is to establish industry-leading positions in large and rapidly
growing segments of ophthalmology by leveraging our preclinical and development
expertise and our novel and proprietary technologies. We actively explore
opportunities to acquire complementary pharmaceuticals, compounds, and
technologies, which could, individually or in the aggregate, materially increase
the scale of our business. We also intend to explore strategic opportunities
in
other medical markets that would allow us to benefit from our business and
global distribution expertise, and which have operational characteristics that
are similar to ophthalmology, such as dermatology. We are a Delaware
corporation, headquartered in Miami, Florida, with instrumentation operations
in
Toronto, Ontario (Canada) and our clinical operations in Morristown, New
Jersey.
NOTE
2 LIQUIDITY
We
have
not generated positive cash flow from operations, and we expect to incur
losses
from operations for the foreseeable future. We expect to incur substantial
research and development expenses, including expenses related to the hiring
of
personnel and additional clinical trials. We expect that selling, general
and
administrative expenses will also increase as we expand our sales, marketing
and
administrative staff and add infrastructure.
We
do not
believe the cash and cash equivalents on hand at March 31, 2008 will be
sufficient to meet our anticipated cash requirements for operations and debt
service for the next 12 months, and we will require additional funding during
the second half of the year. We base this estimate on assumptions that may
prove
to be wrong or subject to change, and we may be required to use our
available cash resources sooner than we currently expect. If we accelerate
our product development programs or initiate additional clinical trials,
we will
need additional funds earlier. Our future cash requirements will depend on
a number of factors, including the continued progress of our research and
development of product candidates, the timing and outcome of clinical trials
and
regulatory approvals, the costs involved in preparing, filing, prosecuting,
maintaining, defending, and enforcing patent claims and other intellectual
property rights, the status of competitive products, the availability of
financing, and our success in developing markets for our product candidates.
If
we are not able to secure additional funding when needed, we may have to
delay,
reduce the scope of, or eliminate one or more of our clinical trials or research
and development programs.
We
intend
to finance additional research and development projects, clinical trials
and our
future operations with a combination of private placements, payments from
potential strategic research and development, licensing and/or marketing
arrangements, public offerings, debt financing and revenues from future product
sales, if any. We do not currently have any commitments for future external
funding and there can be no assurance that additional capital will be available
to us on acceptable terms, or at all.
NOTE 3
SUMMARY OF SIGNIFICANT ACCCOUNTING POLICIES
Basis
of Presentation.
The
accompanying unaudited interim condensed consolidated financial statements
have
been prepared in accordance with accounting principles generally accepted in
the
United States and with the instructions to Form 10-Q and Article 10 of
Regulation S-X. Accordingly, they do not include all information and
footnotes required by accounting principles generally accepted in the United
States for complete financial statements. In the opinion of management, all
adjustments (consisting of only normal recurring adjustments) considered
necessary to present fairly the Company’s results of operations, financial
position and cash flows have been made. The results of operations and cash
flows
for the three months ended March 31, 2008 are not necessarily indicative of
the
results of operations and cash flows that may be reported for the remainder
of
2008 or for future periods. The interim consolidated financial statements should
be read in conjunction with the consolidated financial statements and the Notes
to Consolidated Financial Statements included in our Annual Report on Form
10-K
for the year ended December 31, 2007.
Principles
of consolidation:
The
accompanying unaudited condensed consolidated financial statements include
the
accounts of OPKO Health, Inc. and our wholly-owned subsidiaries. All significant
inter-company accounts and transactions are eliminated in consolidation.
Use
of Estimates.
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
Reclassifications:
Certain
prior period amounts have been reclassified to conform to the current year’s
presentation.
Recent
accounting
pronouncements:
8
In
February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities, or SFAS 159, which gives companies the option
to measure eligible financial assets, financial liabilities, and firm
commitments at fair value (i.e., the fair value option), on an
instrument-by-instrument basis, that are otherwise not permitted to be accounted
for at fair value under other accounting standards. The election to use the
fair
value option is available when an entity first recognizes a financial asset
or
financial liability or upon entering into a firm commitment. Subsequent changes
in fair value must be recorded in earnings. SFAS 159 is effective for financial
statements issued for fiscal years beginning after November 15, 2007. We adopted
SFAS 159 in the first quarter of 2008 and the adoption did not have a material
impact on our financial position or results of operations as we elected not
to
apply fair value on an instrument-by-instrument basis.
In
June
2007, the Emerging Issues Task Force (Task Force) of the FASB reached a
consensus on Issue No. 07-3 (“EITF 07-3”), Accounting for Nonrefundable
Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities. Under EITF 07-3, nonrefundable advance payments for
goods or services that will be used or rendered for research and development
activities should be deferred and capitalized. Such payments should be
recognized as an expense as the goods are delivered or the related services
are
performed, not when the advance payment is made. If a company does not expect
the goods to be delivered or services to be rendered, the capitalized advance
payment should be charged to expense. EITF 07-3 is effective for new contracts
entered into in fiscal years beginning after December 15, 2007, and interim
periods within those fiscal years. Earlier application is not permitted. We
have
adopted EITF 07-3 as of January 1, 2008. The adoption of EITF 07-3 did not
have a material effect on our consolidated results of operations or financial
condition.
In
December 2007, the FASB issued SFAS No. 141R, Business Combinations. SFAS 141R
will require, among other things, the expensing of direct transaction costs,
including deal costs and restructuring costs as incurred, acquired in-process
research and development assets to be capitalized, certain contingent assets
and
liabilities to be recognized at fair value and earn-out arrangements, including
contingent consideration, may be required to be measured at fair value until
settled, with changes in fair value recognized each period into earnings. In
addition, material adjustments made to the initial acquisition purchase
accounting will be required to be recorded back to the acquisition date. This
will cause companies to revise previously reported results when reporting
comparative financial information in subsequent filings. SFAS No. 141R is
effective for the Company on a prospective basis for transactions occurring
beginning on January 1, 2009 and earlier adoption is not permitted. SFAS No.
141R may have a material impact on the Company’s consolidated financial
position, results of operations and cash flows if we enter into
material business combinations after January 1, 2009.
9
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests
in Consolidated Financial Statements, an Amendment of ARB No. 51” (“SFAS
No. 160”). SFAS No. 160 requires minority interests to be
recharacterized as noncontrolling interests and reported as a component of
equity. In addition, SFAS No. 160 requires that purchases or sales of
equity interests that do not result in a change in control be accounted for
as
equity transactions and, upon a loss of control, requires the interests sold,
as
well as any interests retained, to be recorded at fair value with any gain
or
loss recognized in earnings. SFAS No. 160 is effective for fiscal years
beginning on or after December 15, 2008, with early adoption prohibited. We
do not expect a material impact on our financial statements from the adoption
of
this standard.
In
March
2008, the FASB issued SFAS No. 161 (“SFAS 161”), Disclosures about Derivative
Instruments and Hedging Activities, as an amendment to SFAS No. 133, Accounting
for Derivative Instruments and Hedging Activities. SFAS 161 requires that
objectives for using derivative instruments be disclosed in terms of underlying
risk and accounting designation. The fair value of derivative instruments and
their gains and losses will need to be presented in tabular format in order
to
present a more complete picture of the effects of using derivative instruments.
SFAS 161 is effective for financial statements issued for fiscal years beginning
after November 15, 2008. We are currently evaluating the impact of adopting
this
pronouncement.
NOTE 4
LOSS PER SHARE
Basic
loss per share is computed by dividing our net loss attributable to common
shareholders by the weighted average number of shares outstanding during the
period. When the effects are not anti-dilutive, diluted earnings per share
is
computed by dividing our net loss by the weighted average number of shares
outstanding and the impact of all dilutive potential common shares, primarily
stock options. The dilutive impact of stock options and warrants are determined
by applying the “treasury stock” method.
A
total
of 29,515,241 and 6,334,613 common stock equivalents have been excluded from
the
calculation of net loss per share in the three months ended March 31, 2008
and March 31, 2007, respectively, because their inclusion would be
anti-dilutive.
10
NOTE 5
COMPOSITION OF CERTAIN FINACIAL STATEMENT CAPTIONS
(in
thousands)
|
March
31,
2008
|
December
31,
2007
|
|||||
Accounts
receivable, net
|
|
|
|||||
Accounts
receivable
|
$
|
2,196
|
$
|
2,154
|
|||
Less
allowance for doubtful accounts
|
(465
|
)
|
(465
|
)
|
|||
|
$
|
1,731
|
$
|
1,689
|
|||
Inventories
|
|||||||
Raw
materials (components)
|
$
|
1,770
|
1,913
|
||||
Finished
products
|
737
|
301
|
|||||
Less
provision for inventory reserve
|
-
|
-
|
|||||
|
$
|
2,507
|
$
|
2,214
|
|||
Intangible
assets
|
|||||||
Technology
|
$
|
4,597
|
$
|
4,597
|
|||
Customer
relationships
|
2,978
|
2,978
|
|||||
Covenants
not to compete
|
317
|
317
|
|||||
Tradename
|
195
|
195
|
|||||
Other
|
262
|
262
|
|||||
Less
amortization
|
(578
|
)
|
(150
|
)
|
|||
Goodwill
|
2,018
|
1,732
|
|||||
|
$
|
9,789
|
$
|
9,931
|
On
November 28, 2007, we acquired Ophthalmic Technologies, Inc., or (“OTI”) for
approximately $11.7 million. We allocated the purchase price to the identifiable
tangible and intangible assets acquired and liabilities assumed based on their
respective fair values under the provisions of SFAS No. 141, Business
Combinations (SFAS No. 141). We believe the estimated fair values assigned
to
the OTI assets acquired and liabilities assumed are based on reasonable
assumptions. However, the fair value estimates for the purchase price allocation
may change during the allowable allocation period under SFAS No. 141, which
is
up to one year from the acquisition date, if additional information becomes
available that would require changes to our estimates.
NOTE
6 TERM LOAN
On
January 11, 2008, we repaid, in full, all outstanding amounts and terminated
all
of our commitments under our $4.0 million term loan with Horizon Financial
Funding Company, LLC, which was being repaid monthly since August 2007 and
was
to be paid in full by August 2008. During the first quarter of 2008, the total
amount we repaid in satisfaction of our obligations under the term loan was
$2.4
million.
NOTE
7 COMMITMENTS AND CONTINGENCIES
On
May 7,
2007, Ophthalmic Imaging Systems filed a lawsuit against one of our former
employees for breach of fiduciary duty, intentional interference with contract
and intentional interference with prospective economic advantage. The Company
agreed to indemnify the former employee, who has since been terminated. On
April
14, 2008, the plaintiff was granted leave to file a Second Amended Complaint
to
add claims for tortious interference with prospective business advantage and
aiding and abetting against the Company and The Frost Group, LLC, (a
related party) seeking in excess of $7 million in damages. The Company has
not
yet responded to the complaint, and discovery is ongoing. The Company
believes this action is without merit and intends to vigorously defend
itself. It is too early to assess the probability of a favorable or unfavorable
outcome, or the loss or range of loss or indemnification obligation, if any,
and
therefore, no amounts have been accrued relating to this action.
We
are a
party to litigation in the ordinary course of business. We do not believe that
any such litigation will have a material adverse effect on our business,
financial condition, or results of operations.
11
Upon
the
termination of an employee of OTI, we became obligated at the former employee’s
sole option to acquire up to 10% of the shares issued to the employee in
connection with the acquisition of OTI at a price of $3.55 per share. The total
potential obligation for this former employee is approximately $0.1 million.
In
addition, an existing employee of OTI has the same provision within his
employment arrangement with a potential obligation of approximately $0.3
million. We
have
recorded approximately $0.2 million as of March 31, 2008 based on the estimated
fair market value of these put options as an accrued expense.
On
March
25, 2008, OTI received a warning letter in connection with a FDA inspection
of
OTI’s Toronto facility in July and August of 2007. The warning letter cited
several deficiencies in OTI’s quality, record keeping, and reporting systems
relating to certain of OTI’s products, including the OTI Scan 1000, OTI Scan
2000, and OTI OCT/SLO combination imaging system. Based upon the observations
noted in the warning letter, OTI is not currently in compliance with cGMP.
The
FDA indicated that it has issued an Import Alert and may refuse admission
of
these products into the United States. As a result, we will not be permitted
to
sell these devices in the United States, and our pending 510(k) pre-market
notification submission for the OCT/SLO combination imaging system will be
delayed until the violations have been corrected. We have determined that
a
limited number of the OCT/SLO imaging systems were shipped to customers in
the
United States prior to our receipt of the warning letter and prior to clearance
of a 510(k) submission. We have contacted our customers to recover
the
limited
number of OCT/SLO products at issue and are in the process of reimbursing
customers for such products. We are also evaluating the amount of any
reimbursement made by federal health care programs for procedures utilizing
the
OCT/SLO device.
We
are
cooperating fully with the FDA, and will continue to work with the agency
on all
of the above-referenced issues. Upon receipt of the warning letter, we
immediately began to take corrective action to address the FDA’s concerns and to
assure the quality of OTI’s products. We are committed to providing high quality
products to our customers, and we plan to meet this commitment by working
diligently to remedy these deficiencies and to implement updated and improved
quality systems and concepts throughout the OTI organization.
NOTE 8
RELATED PARTY TRANSACTIONS
Our
principal corporate office is located at 4400 Biscayne Blvd, Suite 1180,
Miami,
Florida. We lease this space from Frost Real Estate Holdings, LLC, an entity
which is controlled by Dr. Phillip Frost, our Chairman of the Board and Chief
Executive Officer. Pursuant to the lease agreement with Frost Real Estate
Holdings (the “Lease”), we lease approximately 8,300 square feet, which
encompasses space for our corporate offices, administrative services,
preclinical research and development, project management and pharmacology.
The
Lease is for a five-year term and currently requires annual rent of
approximately $221,000, which amount increases by approximately 4.5% per
year.
Effective
as of January 1, 2008, we began leasing an additional 1,100 square feet of
general office and laboratory space on a ground floor annex of our corporate
office building. Pursuant to an addendum to the Lease, we will be required
to
pay annual rent of $19,872 per year for the annex space, which amount will
be
subject to a 4.5% increase each year, and shall otherwise be governed by
the
terms of the Lease.
We
reimburse Dr. Frost for Company-related use by Dr. Frost and our other
executives of an airplane owned by a company that is beneficially owned by
Dr. Frost. We reimburse Dr. Frost in an amount equal to the cost of a
first class airline ticket between the travel cities for each executive,
including Dr. Frost, traveling on the airplane for Company-related
business. We do not reimburse Dr. Frost for personal use of the airplane by
Dr. Frost or any other executive. Nor do we pay for any other fixed or
variable operating costs of the airplane. During the first three months of
2008,
we reimbursed Dr. Frost approximately $42,000 for Company-related travel by
Dr. Frost and other OPKO executives.
NOTE 9
SUBSEQUENT EVENT
On
May 6,
2008, we completed the acquisition of Vidus Ocular, Inc., (“Vidus”) a
privately-held company that is developing Aquashunt™, a shunt to be used in
the treatment of glaucoma. Pursuant to a Securities Purchase Agreement with
Vidus, each of its stockholders, and the holders of convertible promissory
notes
issued by Vidus, we acquired all of the outstanding stock and convertible debt
of Vidus in exchange for (i) the issuance and delivery at closing of 658,080
shares of our common stock (the “Closing Shares”); (ii) the issuance of 488,420
shares of our common stock to be held in escrow pending the occurrence of
certain development milestones (the “Milestone Shares”); and (iii) the issuance
of options to acquire 200,000 shares of our common stock. Additionally, in
the
event that the stock price for our common stock at the time of receipt of
approval or clearance by the U.S. Food & Drug Administration of a pre-market
notification 510(k) relating to the Aquashunt is not at or above a specified
price, we will be obligated to issue an additional 413,850 shares of its common
stock. A portion of the Closing Shares and the Milestone Shares will remain
in
escrow for a period of one year to satisfy indemnification claims.
12
Item 2.
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
OVERVIEW
You
should read this discussion together with the Financial Statements, related
Notes and other financial information included elsewhere in this report and
in
our Annual Report on Form
10-K for the year ended December 31, 2007 (the “ Form
10-K ”).
The following discussion contains assumptions, estimates and other
forward-looking statements that involve a number of risks and uncertainties,
including those discussed under “Risk Factors,” in Part II, Item 1A of our Form
10-K. These risks could cause our actual results to differ materially from
those
anticipated in these forward-looking statements.
We
are a
specialty healthcare company focused on the discovery, development, and
commercialization of proprietary pharmaceuticals, imaging and diagnostic
systems, and instruments for the treatment, diagnosis, and management of
ophthalmic disorders. Our business presently consists of the development of
ophthalmic pharmaceuticals and the development, commercialization and sale
of
ophthalmic diagnostic and imaging systems and instrumentation products. Our
objective is to establish industry-leading positions in large and rapidly
growing segments of ophthalmology by leveraging our preclinical and development
expertise and our novel and proprietary technologies. We actively explore
opportunities to acquire complementary pharmaceuticals, compounds, and
technologies, which could, individually or in the aggregate, materially increase
the scale of our business. We also intend to explore strategic opportunities
in
other medical markets that would allow us to benefit from our business and
global distribution expertise, and which have operational characteristics that
are similar to ophthalmology, such as dermatology.
We
expect
to incur substantial losses as we continue the development of our product
candidates, particularly bevasiranib, continue our other research and
development activities, and establish a sales and marketing infrastructure
in
anticipation of the commercialization of our product candidates. We currently
have limited commercialization capabilities, and it is possible that we may
never successfully commercialize any of our pharmaceutical product candidates.
To date, we have devoted a significant portion of our efforts towards research
and development. As of March 31, 2008, we had an accumulated deficit of $280.2
million. Since we do not generate revenue from any of our pharmaceutical product
candidates and have only generated limited revenue from our instrumentation
business, we expect to continue to generate losses in connection with the
continued clinical development of bevasiranib and the research and development
activities relating to our technology and other product candidates. Such
research and development activities are budgeted to expand over time and will
require further resources if we are to be successful. As a result, we believe
that our operating losses are likely to be substantial over the next several
years. We will need to obtain additional funds to further develop our research
and development programs, and there can be no assurance that additional capital
will be available to us on acceptable terms, or at all.
RESULTS
OF OPERATIONS
FOR
THE THREE MONTHS ENDED MARCH 31, 2008 AND 2007
The
results for the period ended March 31, 2007 include Froptix’s results for the
full period and the results of operations from Acuity Pharmaceuticals, Inc.,
or
Acuity, subsequent to our acquisition on March 27, 2007. The three month period
ended March 31, 2008 includes the operations of both Froptix and Acuity as
well
as the operation of OTI, which we acquired in November 28, 2007.
Revenue.
Revenue
for the three months ended March 31, 2008 was $2.8 million. All revenue was
generated from sales of OTI’s ophthalmic instrumentation products. Until the
acquisition of OTI on November 28, 2007, we did not generate any revenue. During
2008, the majority of our revenue is from international sales. There were
no OCT/SLO product sales in the U.S. during the first three months of 2008
pending clearance of the premarket notification 510(k) for that device by the
U.S. Food and Drug Administration. We anticipate revenue will decrease during
the second quarter of 2008 as we move production of components for the OCT/SLO
in-house.
Gross
margin (deficit).
Gross
margin (deficit) for the three months ended March 31, 2008 was ($0.5) million
and was entirely related to our ophthalmic instrumentation product sales.
The gross margin (deficit) was negatively impacted by manufacturing
costs associated with the introduction of our new OCT/SLO model. In
additional, during the first three months of 2008, gross margin (deficit) was
negatively impacted as we incurred approximately $0.4 million to bring the
manufacturing of our OCT/SLO product in-house including costs associated with
production development. We
anticipate that our margin will improve as we begin manufacturing more
components in-house and as we begin selling the OCT/SLO product in the
U.S.
13
Selling,
General and Administrative Expense.
Selling,
general and administrative expense for the three months ended March 31, 2008
was
$5.3 million compared to $90,000 of expense for the comparable period of
2007. Selling, general and administrative expense primarily related to personnel
costs, including stock-based compensation of $2.1 million, of which
approximately $1.4 million related to the acceleration of vesting for stock
options in connection with the termination of certain employees, and
professional fees. In addition, as a result of our acquisition of OTI on
November 28, 2007, our selling expenses reflect a full three months of post
acquisition activity for OTI. As we prepare to sell OTI’s OCT/SLO product in the
U.S., we anticipate these expenses will increase throughout the year. We
acquired Acuity on March 27, 2007 and we had limited operations prior to that
resulting in limited operating expenses during the 2007 period. The 2007 period
includes approximately $35,000 of expense related to stock-based compensation
and professional fees.
Research
and Development Expense.
Research
and development expense during the three months ended March 31, 2008 was $4.4
million compared to $6.1 million for the comparable period of 2007. The 2008
period expense primarily reflects the cost of our ongoing Phase III clinical
trial for bevasiranib, including costs of clinical trial sites and monitoring
expenses, personnel costs and outside professional fees also. Included in
personnel costs for the 2008 three month period was $0.6 million in stock based
compensation expense. Research and development expense for the three month
period of 2007 primarily relates to stock based compensation expense of $6.0
million, of which $5.9 million was reversed in the third quarter of 2007 as
a
result of the termination of a consulting agreement. Under SFAS 123R, when
a stock based compensation award is forfeited prior to vesting, all
compensation expense recorded in previous periods is reversed in the period
of
forfeiture.
Write-off
of Acquired In-Process Research and Development.
On
March 27, 2007, we acquired Acuity in a stock for stock transaction. We
recorded the assets and liabilities at fair value, and as a result, we recorded
acquired in-process research and development expense and recorded a charge
of
$243.8 million. We did not have any such activity during the 2008
period.
Other
Income and Expenses.
Other
expense was $0.3 million, net of $0.1 million of interest income for
the first three months of 2008 compared to $12,000 of interest expense for
the
2007 period. Other income primarily consists of interest earned on our cash
and
cash equivalents and interest expense reflects the interest incurred on our
line
of credit. Other operating expenses primarily include amortization of our
intangible assets acquired from OTI on November 28, 2007. As such, we did not
record any amortization expense during the first three months of 2007. Further,
income tax benefit for the first quarter of 2008 reflects the Canadian
provincial tax credit that is refundable once we file our tax return. This
credit relates to Research and Development expenses incurred at our OTI
locations. We acquired OTI on November 28, 2007 and as a result, did not have
similar refundable credits during the first three months of 2007.
At
March
31, 2008, we had cash and cash equivalents of approximately $14.6 million.
Cash used in operations primarily reflects our net loss, offset by our non-cash
stock based compensation and amortization expenses as well as working capital
changes in our balance sheet. Since our inception, we have not generated
positive cash flow from operations and our primary source of cash has been
from
the private placement of stock and through credit facilities available to
us.
We
had a
$4.0 million term loan with Horizon Financial Funding Company, LLC, or Horizon,
which had an interest rate of 12.23%. The principal was payable in 12 equal
monthly installments which commenced August 2007. On January 11, 2008, we repaid
in full all outstanding amounts and terminated all of our commitments under
the
term loan with Horizon. The total amount repaid in satisfaction of our
obligations under the term loan was $2.4 million. We realized a net savings
by
avoiding future interest charges over the remaining term of the
obligation.
In
addition, we have a $12.0 million line of credit with The Frost Group, LLC,
or
the Frost Group, a related party. The Frost Group members include a trust
controlled by Dr. Phillip Frost, who is the Company’s Chief Executive
Officer and Chairman of the board of directors, Dr. Jane H. Hsiao, who is
the Vice Chairman of the board of directors and Chief Technical Officer, Steven
D. Rubin who is Executive Vice President - Administration and a director of
the
Company, and Rao Uppaluri who is the Chief Financial Officer of the Company.
We
are obligated to pay interest upon maturity, capitalized quarterly, on
outstanding borrowings under the line of credit at a 10% annual rate, which
is
due July 11, 2009. The line of credit is collateralized by all of our personal
property except our intellectual property.
We
have
not generated positive cash flow from operations, and expect to incur
losses from operations for the foreseeable future. We expect to incur
substantial research and development expenses, including expenses related
to the
hiring of personnel and additional clinical trials. We expect that selling,
general and administrative expenses will also increase as we expand our sales,
marketing and administrative staff and add
infrastructure.
14
We
do not
believe the cash and cash equivalents on hand at March 31, 2008 will be
sufficient to meet our anticipated cash requirements for operations and debt
service for the next 12 months, and we will require additional funding during
the second half of the year. We based this estimate on assumptions that may
prove to be wrong or subject to change, and we may be required to use our
available cash resources sooner than we currently expect. If we accelerate
our product development programs or initiate additional clinical trials, we
will
need additional funds earlier. Our future cash requirements will depend on
a number of factors, including the continued progress of our research and
development of product candidates, the timing and outcome of clinical trials
and
regulatory approvals, the costs involved in preparing, filing, prosecuting,
maintaining, defending, and enforcing patent claims and other intellectual
property rights, the status of competitive products, the availability of
financing, and our success in developing markets for our product candidates.
If
we are not able to secure additional funding when needed, we may have to delay,
reduce the scope of, or eliminate one or more of our clinical trials or research
and development programs.
We
intend
to finance additional research and development projects, clinical trials and
our
future operations with a combination of private placements, payments from
potential strategic research and development, licensing and/or marketing
arrangements, public offerings, debt financing and revenues from future product
sales, if any. We do not currently have any commitments for future external
funding and there can be no assurance that additional capital will be available
to us on acceptable terms, or at all.
CRITICAL
ACCOUNTING POLICIES AND ESTIMATES
Accounting
Estimates.
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of sales and expenses during the reporting period. Actual
results could differ from those estimates.
Stock Based
Compensation.
As of
June 23, 2006 (the date of inception), we adopted Statement of Financial
Accounting Standards, or SFAS No. 123(R). Share-Based Payments SFAS No. 123(R)
replaces SFAS No. 123, Accounting for Stock-Based Compensation, and supersedes
APB No. 25. SFAS No. 123(R) requires that all stock-based compensation be
recognized as an expense in the financial statements and that such cost be
measured at the fair value of the award. Equity-based compensation arrangements
to non-employees are accounted for in accordance with SFAS No. 123(R) and
Emerging Issues Task Force Issue No. 96-18 (EITF 96-18), “Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services,” which requires that these equity
instruments are recorded at their fair value on the measurement date. As
prescribed under SFAS 123(R), we estimate the grant-date fair value of our
stock
option grants using a valuation model known as the Black-Scholes-Merton formula
or the “Black-Scholes Model” and allocate the resulting compensation expense
over the corresponding requisite service period associated with each grant.
The
Black-Scholes Model requires the use of several variables to estimate the
grant-date fair value of stock options including expected term, expected
volatility, expected dividends and risk-free interest rate. We perform
significant analyses to calculate and select the appropriate variable
assumptions used in the Black-Scholes Model. We also perform significant
analyses to estimate forfeitures of equity-based awards as required by SFAS
123(R). We are required to adjust our forfeiture estimates on at least an annual
basis based on the number of share-based awards that ultimately vest. The
selection of assumptions and estimated forfeiture rates is subject to
significant judgment and future changes to our assumptions and estimates may
have a material impact on our Consolidated Financial Statements.
Goodwill
and Intangible Assets.
The
allocation of the purchase price for acquisitions requires extensive use of
accounting estimates and judgments to allocate the purchase price to the
identifiable tangible and intangible assets acquired, including in-process
research and development, and liabilities assumed based on their respective
fair
values under the provisions of SFAS No. 141, Business Combinations (SFAS No.
141). Additionally, we must determine whether an acquired entity is considered
to be a business or a set of net assets, because a portion of the purchase
price
can only be allocated to goodwill in a business combination.
Appraisals
inherently require significant estimates and assumptions, including but not
limited to, determining the timing and estimated costs to complete the
in-process R&D projects, projecting regulatory approvals, estimating future
cash flows, and developing appropriate discount rates. We believe the estimated
fair values assigned to the Acuity and OTI assets acquired and liabilities
assumed are based on reasonable assumptions. However, the fair value estimates
for the purchase price allocation may change during the allowable allocation
period under SFAS No. 141, which is up to one year from the acquisition date,
if
additional information becomes available that would require changes to our
estimates.
15
Allowance
for Doubtful Accounts and Revenue Recognition.
Generally, we recognize revenue from product sales when goods are shipped and
title and risk of loss transfer to our customers. Certain of our products are
sold directly to end-users and require that we deliver, install and train the
staff at the end-users’ facility. As a result, we do not recognize revenue until
the product is delivered, installed and training has occurred. Return policies
in certain international markets for our medical device products provide for
stringent guidelines in accordance with the terms of contractual agreements
with
customers. Our estimates for sales returns are based upon the historical
patterns of products returned matched against the sales from which they
originated, and management’s evaluation of specific factors that may increase
the risk of product returns. The allowance for doubtful accounts recognized
in
our consolidated balance sheets at March 31, 2008 and December 31, 2007 was
$0.5
million and $0.5 million, respectively.
Recent accounting
pronouncements: Fair
Value. We
have
adopted the provisions of Statement of Financials Standards No. 157 Fair
Value Measurements,
or SFAS
157 as of January 1, 2008, for financial assets and liabilities. Although
the adoption of SFAS 157 did not materially impact our financial condition,
results of operations, or cash flows, we are now required to provide additional
disclosures as part of our financial statements.
SFAS
157
establishes a three-tier fair value hierarchy, which prioritizes the inputs
used
in measuring fair value. These tiers include: Level 1, defined as
observable inputs such as quoted prices in active markets; Level 2, defined
as
inputs other than quoted prices in active markets that are either directly
or
indirectly observable; and Level 3, defined as unobservable inputs in which
little or no market data exists, therefore requiring an entity to develop
its
own assumptions.
As
of
March 31, 2008, we held money market funds that are required to be measured
at fair value on a recurring basis.
Any
future fluctuation in fair value related to these instruments that is judged
to
be temporary, including any recoveries of previous write-downs, would be
recorded in accumulated other comprehensive income. If we determine that
any future valuation adjustment was other-than-temporary, we would record
a
charge to earnings as appropriate.
Our
financial assets measured at fair value on a recurring basis, subject to
the
disclosure requirements of SFAS 157 are as follows (in thousands):
|
Fair
Value Measurements at March 31, 2008
|
||||||||||||
|
Quoted Prices in
Active
Markets
for
Identical
Assets
(Level
1)
|
Significant Other
Observable
Inputs
(Level
2)
|
Significant
Unobservable
Inputs
(Level
3)
|
Total
|
|||||||||
Assets:
|
|||||||||||||
Money
Market funds
|
$
|
14,275
|
$
|
—
|
$
|
—
|
$
|
14,275
|
|||||
Total
|
$
|
14,275
|
$
|
—
|
$
|
—
|
$
|
14,275
|
In
February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities, or SFAS 159, which gives companies the option
to measure eligible financial assets, financial liabilities, and firm
commitments at fair value (i.e., the fair value option), on an
instrument-by-instrument basis, that are otherwise not permitted to be accounted
for at fair value under other accounting standards. The election to use the
fair
value option is available when an entity first recognizes a financial asset
or
financial liability or upon entering into a firm commitment. Subsequent changes
in fair value must be recorded in earnings. SFAS 159 is effective for financial
statements issued for fiscal years beginning after November 15, 2007. We adopted
SFAS 159 in the first quarter of 2008 and the adoption did not have a material
impact on our financial position or results of operations as we elected not
to
apply fair value on an instrument-by-instrument basis..
In
June
2007, the Emerging Issues Task Force (Task Force) of the FASB reached a
consensus on Issue No. 07-3 (“EITF 07-3”), Accounting for Nonrefundable
Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities. Under EITF 07-3, nonrefundable advance payments for
goods or services that will be used or rendered for research and development
activities should be deferred and capitalized. Such payments should be
recognized as an expense as the goods are delivered or the related services
are
performed, not when the advance payment is made. If a company does not expect
the goods to be delivered or services to be rendered, the capitalized advance
payment should be charged to expense. EITF 07-3 is effective for new contracts
entered into in fiscal years beginning after December 15, 2007, and interim
periods within those fiscal years. Earlier application is not permitted. We
have
adopted EITF 07-3 as of January 1, 2008. The adoption of EITF 07-3 did not
have a material effect on our consolidated results of operations or financial
condition.
In
December 2007, the FASB issued SFAS No. 141R, Business Combinations. SFAS 141R
will require, among other things, the expensing of direct transaction costs,
including deal costs and restructuring costs as incurred, acquired in-process
research and development assets to be capitalized, certain contingent assets
and
liabilities to be recognized at fair value and earn-our arrangements, including
contingent consideration, may be required to be measured at fair value until
settled, with changes in fair value recognized each period into earnings. In
addition, material adjustments made to the initial acquisition purchase
accounting will be required to be recorded back to the acquisition date. This
will cause companies to revise previously reported results when reporting
comparative financial information in subsequent filings. SFAS No. 141R is
effective for the Company on a prospective basis for transactions occurring
beginning on January 1, 2009 and earlier adoption is not permitted. SFAS No.
141R may have a material impact on the Company’s consolidated financial
position, results of operations and cash flows if we enter into
material business combinations after January 1, 2009.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests
in Consolidated Financial Statements, an Amendment of ARB No. 51” (“SFAS
No. 160”). SFAS No. 160 requires minority interests to be
recharacterized as noncontrolling interests and reported as a component of
equity. In addition, SFAS No. 160 requires that purchases or sales of
equity interests that do not result in a change in control be accounted for
as
equity transactions and, upon a loss of control, requires the interests sold,
as
well as any interests retained, to be recorded at fair value with any gain
or
loss recognized in earnings. SFAS No. 160 is effective for fiscal years
beginning on or after December 15, 2008, with early adoption prohibited. We
do not expect a material impact on our financial statements from the adoption
of
this standard.
16
In
March
2008, the FASB issued SFAS No. 161 (“SFAS 161”), Disclosures about Derivative
Instruments and Hedging Activities, as an amendment to SFAS No. 133, Accounting
for Derivative Instruments and Hedging Activities. SFAS 161 requires that
objectives for using derivative instruments be disclosed in terms of underlying
risk and accounting designation. The fair value of derivative instruments and
their gains and losses will need to be presented in tabular format in order
to
present a more complete picture of the effects of using derivative instruments.
SFAS 161 is effective for financial statements issued for fiscal years beginning
after November 15, 2008. We are currently evaluating the impact of adopting
this
pronouncement.
Item 3.
Quantitative
and Qualitative Disclosures About Market Risk
In
the
normal course of doing business, we are exposed to the risks associated with
foreign currency exchange rates and changes in interest rates. We do not engage
in trading market risk sensitive instruments or purchasing hedging instruments
or “other than trading” instruments that are likely to expose us to significant
market risk, whether interest rate, foreign currency exchange, commodity price,
or equity price risk.
Our
exposure to market risk relates to our cash and investments and to our
borrowings. We maintain an investment portfolio of money market funds and
qualified purchaser funds. The securities in our investment portfolio are not
leveraged, and are, due to their very short-term nature, subject to minimal
interest rate risk. We currently do not hedge interest rate exposure. Because
of
the short-term maturities of our investments, we do not believe that a change
in
market interest rates would have a significant negative impact on the value
of
our investment portfolio except for reduced income in a low interest rate
environment. At March 31, 2008, we had cash and cash equivalents of $14.6
million. The weighted average interest rate related to our cash and cash
equivalents for the year ended March 31, 2008 was 3.7%. As of March 31, 2008,
the principal value of our credit line was $12.0 million, which bears a weighted
average interest rate of 10.0%.
The
primary objective of our investment activities is to preserve principal while
at
the same time maximizing yields without significantly increasing risk. To
achieve this objective, we invest our excess cash in debt instruments of the
U.S. Government and its agencies, bank obligations, repurchase agreements and
high-quality corporate issuers, and money market funds that invest in such
debt
instruments, and, by policy, restrict our exposure to any single corporate
issuer by imposing concentration limits. To minimize the exposure due to adverse
shifts in interest rates, we maintain investments at an average maturity of
generally less than one month.
Item 4T.
Controls
and Procedures
The
Company’s management, under the supervision and with the participation of the
Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”),
has evaluated the effectiveness of the Company’s disclosure controls and
procedures as defined in Securities and Exchange Commission (“SEC”) Rule
13a-15(e) as of March 31, 2008. Based on that evaluation, management has
concluded that the Company’s disclosure controls and procedures are effective to
ensure that information the Company is required to disclose in reports that
it
files or submits under the Securities Exchange Act is communicated to
management, including the CEO and CFO, as appropriate, to allow timely decisions
regarding required disclosure and is recorded, processed, summarized, and
reported within the time periods specified in the SEC’s rules and
forms.
Beginning
in the fourth quarter of 2007 and continuing into the first quarter of 2008,
we
have implemented standards and procedures at OTI, upgrading and establishing
controls over accounting systems, and adding employees who are trained and
experienced in the preparation of financial statements in accordance with U.S.
GAAP to ensure that we have in place appropriate internal control over financial
reporting at OTI.
Other
than as set forth above with respect to OTI, there have been no changes to
the
Company’s internal control over financial reporting that occurred during the
Company’s first quarter of 2008 that have materially affected, or are reasonably
likely to materially affect, the Company’s internal control over financial
reporting.
PART
II. OTHER INFORMATION
On
May 7,
2007, Ophthalmic Imaging Systems, or OIS, sued Steven Verdooner, its former
president and our then Executive Vice President, Instrumentation, in California
Superior Court for the County of Sacramento. The complaint sought damages
for breach of fiduciary duty, intentional interference with contract and
intentional interference with prospective economic advantage. On August 31,
2007, OIS filed a First Amended Complaint, re-alleging its claims and seeking
damages in excess of $7,000,000 from Mr. Verdooner. The Company agreed to
indemnify Mr. Verdooner in connection with this action as a former
officer. His employment with the Company was terminated on January 11,
2008.
17
On
April
14, 2008, OIS was granted leave to file a Second Amended Complaint to add claims
for tortious interference with contractual relations and prospective
business advantage and aiding and abetting against the Company and The
Frost Group, LLC. The Frost Group members include a trust controlled by
Dr. Phillip Frost, the Company’s Chief Executive Officer and Chairman,
Dr. Jane H. Hsiao, Vice Chairman of the board of directors and Chief
Technical Officer, Steven D. Rubin, Executive Vice President - Administration
and a director of the Company, and Rao Uppaluri, the Chief Financial Officer
of
the Company. OIS filed the Second Amended Complaint on April 23, 2008,
claiming in excess of $7,000,000 in damages against the Company and the Frost
Group for intentional interference, conspiracy and aiding and abetting, along
with enhanced damages, injunctive relief and costs and attorneys'
fees. The Company believes this action is without merit and intends
to vigorously defend the claims. The
Company has not yet responded to the complaint, and discovery is ongoing.
No trial date has been set.
Item 1A.
Risk
Factors
In
addition to the other information set forth in this report, you should carefully
consider the factors described in the “Risk Factors” section in our Annual
Report on Form 10-K for the year ended December 31, 2007, which could materially
affect our business, results of operations, financial condition or liquidity.
The risks described in our Annual Report are not the only risk facing us.
Additional risks and uncertainties not currently known to us or that we
currently believe are immaterial also may materially adversely affect our
business, results of operations, financial condition or liquidity. There have
been no material changes to the risks described in our Annual
Report.
None.
None.
None.
None.
18
Exhibit
Number
|
|
Description
|
2.1
(1)
|
|
Amended
and Restated Certificate of Incorporation.
|
|
|
|
2.2
(2)
|
|
Amended
and Restated By-Laws.
|
|
|
|
31.1
|
|
Certification
by Phillip Frost, Chief Executive Officer, pursuant to Exchange Act
Rules
13a-14 and 15d-14.
|
|
|
|
31.2
|
|
Certification
by Rao Uppaluri, Chief Financial Officer, pursuant to Exchange Act
Rules 13a-14 and 15d-14.
|
|
|
|
32.1
|
|
Certification
by Phillip Frost, Chief Executive Officer, pursuant to 18 U.S.C.
Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of
2002.
|
|
|
|
32.2
|
|
Certification
by Rao Uppaluri, Chief Financial Officer, pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of
2002.
|
(1)
|
|
Filed
with the Company’s Current Report on Form 8-A filed with the Securities
and Exchange Commission on June 11, 2007, and incorporated herein
by
reference.
|
||
|
|
|
||
(2)
|
|
Filed
with the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission on March 31, 2008 for the Company’s fiscal year
ended December 31, 2007, and incorporated herein by
reference.
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
caused this Report on Form 10-Q to be signed on its behalf by the undersigned
thereunto duly authorized.
Date:
May 14, 2008
|
OPKO
Health, Inc.
|
|
|
|
/s/
Adam
Logal
|
|
|
Adam
Logal
|
|
|
Executive
Director of Finance, Chief Accounting Officer and
Treasurer
|
EXHIBIT
INDEX
31.1
|
|
Certification
by Phillip Frost, Chief Executive Officer, pursuant to Exchange Act
Rules
13a-14 and 15d-14.
|
|
|
|
31.2
|
|
Certification
by Rao Uppaluri, Chief Financial Officer, pursuant to Exchange Act
Rules 13a-14 and 15d-14.
|
|
|
|
32.1
|
|
Certification
by Phillip Frost, Chief Executive Officer, pursuant to 18 U.S.C.
Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of
2002.
|
|
|
|
32.2
|
|
Certification
by Rao Uppaluri, Chief Financial Officer, pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of
2002.
|
19