UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended March 31, 2011.
OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from ________ to _______.
Commission file number
001-33528
OPKO Health, Inc.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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75-2402409
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(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.
Miami, FL 33137
(Address of Principal Executive Offices) (Zip Code)
(305) 575-4100
(Registrants 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.
þ
YES
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NO
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
YES
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NO
o
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 (in Rule 12b-2 of the Exchange Act)
(Check one):
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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(Do not check if a smaller reporting company)
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Smaller reporting company
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act): YES
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NO
þ
As of May 1, 2011, the registrant had 285,060,055 shares of common stock outstanding.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements, as that term is
defined under the Private Securities Litigation Reform 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, 2010, and described from time to time in our reports filed with the Securities and
Exchange Commission. Except as required by law, 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:
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We have a history of operating losses and we do not expect to become profitable in
the near future.
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Our technologies are in an early stage of development and are unproven.
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Our drug research and development activities may not result in commercially viable
products.
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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-U.S. regulatory authorities.
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We will require substantial additional funding, which may not be available to us on
acceptable terms, or at all.
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Our business is substantially dependant on our ability to develop, launch and
generate revenue from our molecular diagnostic program.
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We expect to finance future cash needs primarily through public or private offerings,
debt financings or strategic collaborations, which may dilute your stockholdings in the
Company.
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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.
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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.
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Failure to recruit and enroll patients for clinical trials may cause the development
of our product candidates to be delayed.
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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.
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We may not meet regulatory quality standards applicable to our manufacturing and
quality processes.
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Even if we receive regulatory approval to market our product candidates, the market
may not be receptive to our products.
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3
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If we fail to attract and retain key management and scientific personnel, we may be
unable to successfully develop or commercialize our product candidates.
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In the event that we successfully 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.
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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.
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We have no experience manufacturing our pharmaceutical product candidates other than
our Mexican facility 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 if and when we commence manufacturing.
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We currently have no pharmaceutical or diagnostic marketing, sales or distribution
capabilities other than in Chile and Mexico for sales in those countries. 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.
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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 is dependent on the actions of our collaborative
partners.
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Our license agreement with TESARO, Inc. is important to our business. If TESARO does
not successfully develop and commercialize rolapitant, our business could be adversely
affected.
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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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We do not have an exclusive arrangement in place with Dr. Tom Kodadek with respect to
technology or intellectual property that may be material to our business.
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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.
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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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Adverse results in material litigation matters or governmental inquiries could have a
material adverse effect upon our business and financial condition.
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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.
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We may not have the funding available to pursue acquisitions.
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Acquisitions may disrupt our business, distract our management and may not proceed as
planned; and we may encounter difficulties in integrating acquired businesses.
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4
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Non-U.S. governments often impose strict price controls, which may adversely affect
our future profitability.
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Our business may become subject to legal, economic, political, regulatory and other
risks associated with international operations.
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The market price of our common stock may fluctuate significantly.
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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 stockholders.
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Compliance with changing regulations concerning corporate governance and public
disclosure may result in additional expenses.
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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.
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We may be unable to maintain our listing on the NYSE Amex, which could cause our
stock price to fall and decrease the liquidity of our common stock.
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Future issuances of common stock and hedging activities may depress the trading price
of our common stock.
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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.
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We do not intend to pay cash dividends on our common stock in the foreseeable future.
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5
PART I. FINANCIAL INFORMATION
Unless the context otherwise requires, all references in this Quarterly Report on Form 10-Q to
the Company, OPKO, we, our, ours, and us refer to OPKO Health, Inc., a Delaware
corporation, including our wholly-owned subsidiaries.
Item 1.
Financial Statements
OPKO Health, Inc. and Subsidiaries
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited) (in thousands except share data)
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March 31, 2011
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December 31, 2010
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ASSETS
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Current assets
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Cash and cash equivalents
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$
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47,879
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$
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18,016
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Marketable securities
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59,983
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Accounts receivable, net
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14,001
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13,317
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Inventory, net
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18,137
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19,957
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Prepaid expenses and other current assets
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2,785
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2,782
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Total current assets
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142,785
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54,072
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Property and equipment, net
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2,771
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2,729
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Intangible assets, net
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19,355
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9,964
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Goodwill
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6,672
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5,856
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Investments
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4,691
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5,114
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Other assets
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33
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111
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Total assets
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$
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176,307
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$
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77,846
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LIABILITIES, SERIES D PREFERRED STOCK, AND
SHAREHOLDERS EQUITY
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Current liabilities
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Accounts payable
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$
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4,574
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$
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7,170
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Accrued expenses
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5,557
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5,739
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Current portion of lines of credit
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14,552
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14,690
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Total current liabilities
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24,683
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27,599
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Long-term liabilities
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1,883
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1,067
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Total liabilities
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26,566
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28,666
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Commitments and contingencies
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Series D preferred stock $0.01 par value, 2,000,000 shares authorized; 1,209,677
and 1,209,677 shares issued and outstanding (liquidation value of $33,613
and $33,013) at March 31, 2011 and December 31, 2010, respectively
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26,128
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26,128
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Shareholders equity
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Series A Preferred stock $0.01 par value, 4,000,000 shares authorized;
722,700 and 897,439 shares issued and outstanding (liquidation value of
$2,076 and $2,468) at March 31, 2011 and December 31, 2010,
respectively
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7
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9
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Series C Preferred Stock $0.01 par value, 500,000 shares authorized;
No shares issued or outstanding
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Common Stock $0.01 par value, 500,000,000 shares authorized;
285,042,867 and 255,412,706 shares issued and outstanding at
March 31, 2011 and December 31, 2010, respectively
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2,850
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2,554
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Treasury stock - 45,154 shares at March 31, 2011 and December 31, 2010
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(61
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(61
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Additional paid-in capital
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482,521
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376,008
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Accumulated other comprehensive income
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2,424
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2,921
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Accumulated deficit
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(364,128
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)
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(358,379
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)
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Total shareholders equity
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123,613
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23,052
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Total liabilities, Series D Preferred Stock, and shareholders equity
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$
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176,307
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$
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77,846
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The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of
these statements
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6
OPKO Health, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except share data)
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For the three months ended March 31,
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2011
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2010
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Revenue
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Product sales
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$
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8,635
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$
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7,922
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Other revenue
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13
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Total revenue
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8,648
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7,922
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Cost of goods sold, excluding amortization of intangible assets
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5,623
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5,528
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Gross margin, excluding amortization of intangible assets
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3,025
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2,394
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Operating expenses
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Selling, general and administrative
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5,586
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4,243
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Research and development
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1,645
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1,328
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Other operating expenses, principally amortization of
intangible assets
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880
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889
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Total operating expenses
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8,111
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6,460
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Operating loss
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(5,086
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(4,066
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Other income (expense), net
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38
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(340
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Loss before income taxes and investment losses
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(5,048
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(4,406
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Income tax provision
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233
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47
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Loss before investment losses
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(5,281
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)
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(4,453
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)
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Loss from investments in investees
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(423
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)
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(231
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)
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Net loss
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(5,704
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)
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(4,684
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)
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Preferred stock dividend
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(645
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)
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(662
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)
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Net loss attributable to common shareholders
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$
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(6,349
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)
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$
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(5,346
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)
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Loss per share, basic and diluted
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$
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(0.02
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$
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(0.02
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Weighted average number of common shares outstanding, basic
and diluted
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261,042,274
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254,452,451
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The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these
statements
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7
OPKO Health, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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For the three months ended March 31,
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2011
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2010
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Cash flows from operating activities
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Net loss
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$
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(5,704
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)
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$
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(4,684
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)
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Adjustments to reconcile net loss to net cash used in
operating activities:
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Depreciation and amortization
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997
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971
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Accretion of debt discount related to notes payable
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2
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60
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Equity-based compensation employees and non-employees
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1,754
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1,205
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Loss from investments in investees
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423
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231
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Provision for (recovery of) bad debt
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28
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(10
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)
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Provision for (reversal of) inventory reserves
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62
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(63
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)
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Changes in:
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Accounts receivable
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(598
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)
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(1,668
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)
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Inventory
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1,391
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|
885
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Prepaid expenses and other current assets
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(379
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)
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(272
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)
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Other assets
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80
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103
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Accounts payable
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|
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(2,487
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)
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513
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Accrued expenses
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(254
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)
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50
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Net cash used in operating activities
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(4,685
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(2,679
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Cash flows from investing activity
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Acquisition of businesses, net of cash
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(10,538
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(1,447
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Purchase of marketable securities
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(59,983
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(4,999
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Capital expenditures
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(108
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)
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(203
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)
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Net cash used in investing activity
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(70,629
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(6,649
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Cash flows from financing activities:
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Issuance of common stock, including related parties, net
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104,828
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Borrowing under lines of credit
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3,027
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1,165
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Repayments under lines of credit
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(2,827
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)
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|
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(821
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)
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Proceeds from the exercise of stock options and warrants
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135
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|
|
|
2
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Repayments of notes payable and capital lease obligations
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|
|
|
|
|
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(2
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)
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|
|
|
|
|
|
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Net cash provided by financing activities
|
|
|
105,163
|
|
|
|
344
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
29,863
|
|
|
|
(8,984
|
)
|
Cash and cash equivalents at beginning of period
|
|
|
18,016
|
|
|
|
42,658
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
47,879
|
|
|
$
|
33,674
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL INFORMATION
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$
|
65
|
|
|
$
|
46
|
|
Issuance of capital stock to acquire Exakta-OPKO
|
|
$
|
|
|
|
$
|
1,999
|
|
The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these
statements
.
8
OPKO Health, Inc. and Subsidiaries
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
NOTE 1 BUSINESS AND ORGANZATION
We are a multi-national pharmaceutical and diagnostics company that seeks to establish
industry-leading positions in large and rapidly growing medical markets by leveraging our
discovery, development and commercialization expertise and our novel and proprietary technologies.
Our current focus is on conditions with major unmet medical needs including neurological disorders,
infectious diseases, oncology and ophthalmologic diseases. We are developing a range of solutions
to diagnose, treat and prevent these conditions, including molecular diagnostics tests, proprietary
pharmaceuticals and vaccines. We plan to commercialize these solutions on a global basis in large
and high growth markets, including emerging markets. We have already established emerging markets
pharmaceutical platforms in Chile and Mexico, which are delivering revenue and which we expect to
deliver cash flow and facilitate future market entry for our products currently in development. We
also actively explore opportunities to acquire complementary pharmaceuticals, compounds,
technologies, and businesses. We are a Delaware corporation, headquartered in Miami, Florida.
NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING 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 notes 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 Companys 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, 2011, are not
necessarily indicative of the results of operations and cash flows that may be reported for the
remainder of 2011 or for future periods. The unaudited condensed 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, 2010.
Principles of consolidation
. The accompanying unaudited condensed consolidated financial
statements include the accounts of OPKO Health, Inc. and our wholly-owned subsidiaries. All
significant intercompany 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.
Cash and Cash Equivalents.
Cash and cash equivalents consist of short-term, interest-bearing
instruments with original maturities of 90 days or less at the date of purchase. We also consider
all highly liquid investments with original maturities at the date of purchase of 90 days or less
as cash equivalents. These investments include money markets, bank deposits, and U.S. treasury
securities.
Marketable securities.
Investments with original maturities of greater than 90 days and
remaining maturities of less than one year are classified as marketable securities. Marketable
securities include U.S. treasury securities. Unrealized gains and temporary losses on investments
are included in accumulated other comprehensive income (loss) as a separate component of
stockholders equity. Realized gains and losses, dividends, interest income, and declines in value
judged to be other-than-temporary credit losses are included in other income (expense).
Amortization of any premium or discount arising at purchase is included in interest income.
Comprehensive loss.
Our comprehensive loss for the three months ended March 31, 2011 was $6.2
million and includes our net loss and the cumulative translation adjustment, net, for the
translation of our subsidiaries in Chile and Mexico. Comprehensive loss for the three months ended
March 31, 2010 was $5.0 million and includes our net loss for the three months and the cumulative
translation adjustment, net, for the translation of the results of our subsidiaries in Chile and
Mexico.
9
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 instrumentation
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 for instrumentation products sold to end-users.
Other revenues include revenue related to upfront license payments, license fees and milestone
payments received through our license, collaboration and commercialization agreements. We analyze
our multiple-element arrangements to determine whether the elements can be separated and accounted
for individually as separate units of accounting.
Non-refundable license fees for the out-license of our technology are recognized depending on
the provisions of each agreement. We recognize non-refundable upfront license payments as revenue
upon receipt if the license has standalone value and the fair value of our undelivered obligations,
if any, can be determined. If the license is considered to have standalone value but the fair value
of any of the undelivered items cannot be determined, the license payments are recognized as
revenue over the period of our performance for such undelivered items or services. License fees
with ongoing involvement or performance obligations are recorded as deferred revenue once received
and generally are recognized ratably over the period of such performance obligation only after both
the license period has commenced and we have delivered the technology. Our assessment of our
obligations and related performance periods requires significant management judgment. If an
agreement contains research and development obligations, the relevant time period for the research
and development phase is based on management estimates and could vary depending on the outcome of
clinical trials and the regulatory approval process. Such changes could materially impact the
revenue recognized, and as a result, management reviews the estimates related to the relevant time
period of research and development on a quarterly basis.
Revenue from milestone payments related to arrangements under which we have continuing
performance obligations are recognized as revenue upon achievement of the milestone only if all of
the following conditions are met: the milestone payments are non-refundable; there was substantive
uncertainty at the date of entering into the arrangement that the milestone would be achieved; the
milestone is commensurate with either the vendors performance to achieve the milestone or the
enhancement of the value of the delivered item by the vendor; the milestone relates solely to past
performance; and the amount of the milestone is reasonable in relation to the effort expended or
the risk associated with the achievement of the milestone. If any of these conditions are not met,
the milestone payments are not considered to be substantive and are, therefore, deferred and
recognized as revenue over the term of the arrangement as we complete our performance obligations.
Total deferred revenue related to other revenues was $0.2 million and $0.2 million at March
31, 2011 and December 31, 2010, respectively.
Derivative financial instruments.
We record derivative financial instruments on our balance
sheet at their fair value and the changes in the fair value are recognized in income when they
occur, the only exception being derivatives that qualify as hedges. To qualify the derivative
instrument as a hedge, we are required to meet strict hedge effectiveness and contemporaneous
documentation requirements at the initiation of the hedge and assess the hedge effectiveness on an
ongoing basis over the life of the hedge. At March 31, 2011 and December 31, 2010, our forward
contracts for inventory purchases did not meet the documentation requirements to be designated as
hedges. Accordingly, we recognize all changes in fair values in income. Refer to Note 7.
Product warranties.
Product warranty expense is recorded concurrently with the recording of
revenue for product sales. The costs of warranties are accounted for as a component of cost of
sales. We estimate warranty costs based on our estimated historical experience and adjust for any
known product reliability issues.
Allowance for doubtful accounts.
We analyze accounts receivable and historical bad debt
levels, customer credit worthiness and current economic trends when evaluating the adequacy of the
allowance for doubtful accounts using the specific identification method. Our reported net loss is
directly affected by our estimate of the collectability of accounts receivable. Estimated
allowances for sales returns are based upon our history of product returns. The amount of
allowance for doubtful accounts was $1.2 million at March 31, 2011 and December 31, 2010.
Segment reporting
. Our chief operating decision-maker (CODM) is comprised of our executive
management with the oversight of our board of directors. Our CODM review our operating results and
operating plans and make resource allocation decisions on a company-wide or aggregate basis.
Accordingly, we have aggregated our three operating segments, instrumentation, pharmaceutical
operating business and pharmaceutical research and
10
development activities into two reporting segments, instrumentation and pharmaceutical as we
expect the businesses to have similar long-term economic characteristics.
Equity-based compensation.
We measure the cost of employee services received in exchange for
an award of equity instruments based on the grant-date fair value of the award. That cost is
recognized in the statement of operations over the period during which an employee is required to
provide service in exchange for the award. We record excess tax benefits, realized from the
exercise of stock options as a financing cash inflow rather than as a reduction of taxes paid in
cash flow from operations. Equity-based compensation arrangements to non-employees are recorded at
their fair value on the measurement date. The measurement of equity-based compensation is subject
to periodic adjustment as the underlying equity instruments vest. During the three months ended
March 31, 2011 and 2010, we recorded $1.8 million and $1.2 million, respectively, of equity-based
compensation expense.
Recent accounting pronouncements.
In December 2010, the FASB issued an amendment to the
disclosure of supplementary pro forma information for business combinations. The amendment
specifies that if a public entity presents comparative financial statements, the entity should
disclose revenue and earnings of the combined entity as though the business combination(s) that
occurred during the current year had occurred as of the beginning of the comparable prior annual
reporting period only. The amendment also expands the supplemental pro forma disclosures under
current accounting guidance to include a description of the nature and amount of material,
nonrecurring pro forma adjustments directly attributable to the business combination included in
the reported pro forma revenue and earnings. The amendment is effective prospectively for business
combinations for which the acquisition date is on or after the beginning of the first annual
reporting period beginning on or after December 15, 2010. The adoption of this amendment did not
have a material impact on our financial statement disclosures.
In December 2010, the FASB issued an amendment to the accounting for goodwill impairment
tests. The amendment modifies Step 1 of the impairment test for reporting units with zero or
negative carrying amounts. For those reporting units, an entity is required to perform Step 2 of
the goodwill impairment test if it is more likely than not that a goodwill impairment exists. In
determining whether it is more likely than not that a goodwill impairment exists, an entity should
consider whether there are any adverse qualitative factors indicating that an impairment may exist.
The qualitative factors are consistent with the existing guidance. The amendment is effective for
fiscal years, and interim periods within those years, beginning after December 15, 2010. The
adoption of this amendment did not have a material impact on our results of operations or financial
condition.
In December 2010, the FASB issued an amendment to the accounting for annual excise taxes paid
to the federal government by pharmaceutical manufacturers under health care reform. The liability
for the fee should be estimated and recorded in full upon the first qualifying branded prescription
drug sale with a corresponding deferred cost that is amortized to expense using a straight-line
method of allocation unless another method better allocates the fee over the calendar year that it
is payable. The amendment is effective for calendar years beginning after December 31, 2010, when
the fee initially becomes effective. As we currently do not manufacture pharmaceutical products in
the United States, we do not expect the adoption of this amendment to have a material impact on our
results of operations or financial condition.
In March 2010, the FASB reached a consensus to issue an amendment to the accounting for
revenue arrangements under which a vendor satisfies its performance obligations to a customer over
a period of time, when the deliverable or unit of accounting is not within the scope of other
authoritative literature, and when the arrangement consideration is contingent upon the achievement
of a milestone. The amendment defines a milestone and clarifies whether an entity may recognize
consideration earned from the achievement of a milestone in the period in which the milestone is
achieved. This amendment is effective for fiscal years beginning on or after June 15, 2010, with
early adoption permitted. We adopted this amendment prospectively for milestones achieved after
January 1, 2011. This amendment did not have a material impact on our results of operation or
financial condition.
In October 2009, the FASB issued an amendment to the accounting for multiple-deliverable
revenue arrangements. This amendment provides guidance on whether multiple deliverables exist, how
the arrangements should be separated, and how the consideration paid should be allocated. As a
result of this amendment, entities may be able to separate multiple-deliverable arrangements in
more circumstances than under existing accounting guidance. This guidance amends the requirement
to establish the fair value of undelivered products and services based on objective evidence and
instead provides for separate revenue recognition based upon managements best estimate of the
selling price for an undelivered item when there is no other means to determine the fair value of
that undelivered item. The existing guidance previously required that the fair value of the
undelivered item reflect the price of the item either sold in a separate transaction between
unrelated third parties or the price charged for each
11
item when the item is sold separately by the
vendor. If the fair value of all of the elements in the arrangement was
not determinable, then revenue was deferred until all of the items were delivered or fair
value was determined. We adopted this amendment prospectively for revenue arrangements entered
into or materially modified after January 1, 2011. This amendment did not have a material impact
on our results of operation or financial condition.
NOTE 3 LOSS PER SHARE
Basic loss per share is computed by dividing our net loss by the weighted average number of
shares outstanding during the period. 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 28,506,408 and 19,071,146 potential common shares have been excluded from the
calculation of net loss per share for the three months ended March 31, 2011 and 2010, respectively,
because their inclusion would be anti-dilutive. As of March 31, 2011, the holders of our Series A
Preferred Stock and Series D Preferred Stock could convert their Preferred Shares into
approximately 830,511 and 13,553,759 shares of our Common Stock, respectively.
NOTE 4 COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
(in thousands)
|
|
2011
|
|
|
2010
|
|
Accounts receivable, net:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
$
|
15,184
|
|
|
$
|
14,482
|
|
Less allowance for doubtful accounts
|
|
|
(1,183
|
)
|
|
|
(1,165
|
)
|
|
|
|
|
|
|
|
|
|
$
|
14,001
|
|
|
$
|
13,317
|
|
|
|
|
|
|
|
|
Inventories, net:
|
|
|
|
|
|
|
|
|
Raw materials (components)
|
|
$
|
4,784
|
|
|
$
|
4,868
|
|
Work-in process
|
|
|
1,222
|
|
|
|
889
|
|
Finished products
|
|
|
12,634
|
|
|
|
14,632
|
|
Less inventory reserve
|
|
|
(503
|
)
|
|
|
(432
|
)
|
|
|
|
|
|
|
|
|
|
$
|
18,137
|
|
|
$
|
19,957
|
|
|
|
|
|
|
|
|
Intangible assets, net:
|
|
|
|
|
|
|
|
|
Customer relationships
|
|
$
|
7,506
|
|
|
$
|
7,719
|
|
Technology
|
|
|
14,597
|
|
|
|
4,597
|
|
Product registrations
|
|
|
4,232
|
|
|
|
4,227
|
|
Tradename
|
|
|
662
|
|
|
|
666
|
|
Covenants not to compete
|
|
|
387
|
|
|
|
349
|
|
Other
|
|
|
297
|
|
|
|
7
|
|
Less accumulated amortization
|
|
|
(8,326
|
)
|
|
|
(7,601
|
)
|
|
|
|
|
|
|
|
|
|
$
|
19,355
|
|
|
$
|
9,964
|
|
|
|
|
|
|
|
|
The change in value of the intangible assets include the foreign currency fluctuation between the
Chilean and Mexican pesos against the US dollar at March 31, 2011 and December 31, 2010. The increase
in technology and other reflects the acquisition of CURNA, Inc. Refer to Note 5.
NOTE 5 ACQUISITIONS, INVESTMENTS, AND LICENSES
CURNA acquisition
In January 2011, we acquired all of the outstanding stock of CURNA, Inc., (CURNA) in
exchange for $10.0 million in cash, plus $0.6 million in liabilities, of which, $0.5
million was paid at closing. In addition to the cash consideration, we have agreed to pay to the
CURNA sellers a portion of any consideration we receive in connection with certain license,
partnership or collaboration agreements we may enter into with third parties in the future relating
to the CURNA technology, including, license fees, upfront payments, royalties and milestone
payments. As a result, we recorded $0.6 million, as contingent consideration for the future
consideration.
12
We will evaluate the contingent consideration on an ongoing basis and the changes in fair value will
be recognized in earnings until the contingencies are resolved. CURNA was a privately held
company based in Jupiter, Florida, engaged in the discovery of new drugs for the treatment of a
wide variety of illnesses, including cancer, heart disease, metabolic disorders and a range of
genetic anomalies.
The following table reflects the estimated fair value of the net assets acquired at the date
of acquisition:
|
|
|
|
|
(in thousands)
|
|
|
|
|
Current assets (including cash of $5)
|
|
$
|
38
|
|
Fixed assets
|
|
|
21
|
|
Intangible assets
|
|
|
|
|
Technology
|
|
|
10,000
|
|
Patents
|
|
|
290
|
|
|
|
|
|
Total intangible assets
|
|
|
10,290
|
|
Goodwill
|
|
|
828
|
|
Accounts payable and accrued expenses
|
|
|
(54
|
)
|
Contingent consideration
|
|
|
(580
|
)
|
|
|
|
|
Total purchase price
|
|
$
|
10,543
|
|
|
|
|
|
We believe the estimated fair values assigned to the CURNA 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, which is up to one year from
the acquisition date, if additional information becomes available that would require changes to our
estimates.
Exakta-OPKO acquisition
In February 2010, we acquired Exakta-OPKO (previously known as Pharmacos Exakta S.A. de C.V.),
a privately-owned Mexican company engaged in the manufacture, marketing and distribution of
ophthalmic and other pharmaceutical products for government and private markets since 1957.
Pursuant to a purchase agreement we acquired all of the outstanding stock of Exakta-OPKO and real
property owned by an affiliate of Exakta-OPKO for a total aggregate purchase price of $3.5 million,
of which an aggregate of $1.5 million was paid in cash and $2.0 million was paid in shares of our
Common Stock, par value $.01. In September 2010, we reduced the consideration paid by $0.1 million
in working capital adjustments per the purchase agreement. The number of shares to be issued was
determined by the average closing price of our Common Stock as reported on the NYSE Amex for the
ten trading days ending on February 12, 2010. A total of 1,371,428 shares of our Common Stock were
issued in the transaction which were valued at $2.0 million due to trading restrictions. A portion
of the proceeds will remain in escrow for a period of time to satisfy indemnification claims.
Investments
In November 2010, we made an investment in Fabrus, LLC (Fabrus), a privately held early
stage biotechnology company with next generation therapeutic antibody drug discovery and
development capabilities. Fabrus is using its proprietary antibody screening and engineering
approach to discover promising lead compounds against several important oncology targets. As of
March 31, 2011, we hold approximately 13% of Fabrus outstanding membership interests on a fully
diluted basis. Our investment was part of a $2.1 million financing for Fabrus and included other
related parties. Refer to Note 8.
Effective September 21, 2009, we entered into an agreement pursuant to which we invested $2.5
million in cash in Cocrystal Discovery, Inc., a privately held biopharmaceutical company
(Cocrystal). Cocrystal is focused on the discovery and development of novel antiviral drugs
using a combination of protein structure-based approaches. As of March 31, 2011 we hold
approximately 16% of Cocrystal on a fully diluted basis. Refer to Note 8.
On June 10, 2009, we entered into a stock purchase agreement with Sorrento Therapeutics, Inc.
(Sorrento), a publicly held company with a technology for generating fully human monoclonal
antibodies, pursuant to which we invested $2.3 million in Sorrento. OPKO owns approximately
59,015,257 shares of Sorrento Common Stock, or approximately 23% of Sorrentos total outstanding
common stock at March 31, 2011. The closing stock price for Sorrentos common stock, a thinly
traded stock, as quoted on the over-the-counter markets was $0.30 per share on March 31, 2011.
Refer to Note 8.
13
Rolapitant license
In December 2010, we entered into a license agreement (the TESARO License) with TESARO, Inc.
(TESARO) granting TESARO exclusive rights to the development, manufacture, commercialization and
distribution of rolapitant and a related compound. Under the terms of the TESARO License, we are
eligible for payments of up to $121.0 million, including an up-front payment of $6.0 million, which
was received in December 2010, and additional payments based upon achievement of specified
regulatory and commercialization milestones. In addition, TESARO will pay us double digit tiered
royalties on sales of licensed product. We will share future profits from the commercialization of
licensed products in Japan with TESARO and we will have an option to market the products in Latin
America. In connection with the TESARO License, we also acquired an equity position in TESARO. We
recorded the equity position at $0.7 million, the estimated fair value based on a discounted cash
flow model.
In accounting for the license of rolapitant to TESARO, we determined that we did not have any
continuing involvement in the development of rolapitant or any other future performance obligations
and, as a result, recognized the $6.0 million up-front payment and the $0.7 million equity position
as license revenue during the year ended December 31, 2010.
Pursuant to an asset purchase agreement with Schering-Plough Corporation (Schering), we
acquired rolapitant and other assets relating to Scherings neurokinin-1 (NK-1) receptor
antagonist program on October 12, 2009 (the Schering Agreement). Under the terms of the
Schering Agreement, we paid Schering $2.0 million in cash upon closing and agreed to pay up to an
additional $27.0 million upon certain development milestones. Rolapitant, the lead product in the
NK-1 program, successfully completed Phase II clinical testing for prevention of nausea and
vomiting related to cancer chemotherapy and surgery, and other indications. Development of
rolapitant and the other assets had been stopped at the time of our acquisition and there were no
ongoing clinical trials. We recorded $2.0 million as in-process research and development expense
upon our acquisition.
Variable interest entities
We have determined that we hold variable interests (VIE) in three entities, TESARO, Fabrus
and CoCrystal. We made this determination as a result of our assessment that they do not have
sufficient resources to carry out their principal activities without additional subordinated
financial support.
In order to determine the primary beneficiary of Cocrystal and Fabrus, we evaluated our
investment as well as our investment combined with a related party group to identify who had the
most power to control each entity and who received the largest benefits (or absorbed the most
losses) from each entity. The related party group when considering our investment in Cocrystal
includes OPKO and the Frost Group, LLC (the Frost Group). The Frost Group members include Frost
Gamma Investments Trust, of which Phillip Frost, MD, our Chairman of our Board of Directors and
Chief Executive Officer, is the sole trustee (the Gamma Trust), 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. As of March 31, 2011 we own approximately 16% of
Cocrystal and members of the Frost Group own approximately 42% of Cocrystals voting stock on an as
converted basis, including 39% held by the Gamma Trust. Dr. Frost, Mr. Rubin, and Dr. Hsiao
currently serve on the Board of Directors of Cocrystal and represent 50% of its board. The Gamma
Trust can significantly influence Cocrystal through its board representation and voting power. As
such, we have determined that the Gamma Trust is the primary beneficiary within the related party
group.
The related party group when considering our investment in Fabrus includes OPKO and the Gamma
Trust, Hsu Gamma Investment, L.P., of which Jane Hsiao is the general partner (Hsu Gamma), and
the Richard Lerner Family Trust. Dr.s Frost, Hsiao and Lerner are all members of our Board of
Directors. As of March 31, 2011, we own approximately 13% of Fabrus and Drs. Frost, Hsiao and
Lerner own 24% of Fabrus voting stock on an as converted basis, including 16% held by the Gamma
Trust. Drs. Frost and Hsiao currently serve on the Board of Managers of Fabrus and represent 40%
of its board. The Gamma Trust can significantly influence the success of Fabrus through its board
representation and voting power. As such, we have determined that the Gamma Trust is the primary
beneficiary within the related party group. Because we have the ability to exercise significant
influence over Cocrystals and Fabrus operations through our related party affiliates, we account
for our investments in Cocrystal and Fabrus, under the equity method.
In order to determine the primary beneficiary of TESARO, we evaluated the power and benefits
held by its equity holders. On an as converted basis, we hold an equity interest of approximately
6% of TESARO as of
14
March 31, 2011. The decrease in our ownership percentage on an as converted basis from 9% at
December 31, 2010 is a result of TESARO issuing additional equity securities during the three
months ended March 31, 2011. As of March 31, 2011, we determined that despite the issuance of
additional equity securities, TESARO does not have sufficient resources to carry out its principal
activities without additional subordinated financial support. In addition, we do not hold any seats
on the Board of Directors and we do not have any management positions. The largest equity holder
owns approximately 68% of TESARO on an as converted basis and is represented by two members of
TESAROs board of directors. As a result of that equity holder having the power to influence
TESARO and being entitled to the largest share of the benefits of TESARO, we determined such holder
is the primary beneficiary of TESARO. Because we do not have the ability to exercise significant
influence over TESAROs operations, we account for TESARO under the cost method of accounting.
We have not provided financial or other support to the variable interest entities other than
those associated with our original investments in Cocrystal and Fabrus or those associated with our
TESARO License and we are not obligated to provide ongoing financial support to them.
The following table reflects our maximum exposure to each of our investments:
|
|
|
|
|
|
|
|
|
Investee name
|
|
(in thousands)
|
|
|
Accounting method
|
|
|
Sorrento
|
|
$
|
2,300
|
|
|
Equity method
|
Cocrystal
|
|
|
2,500
|
|
|
VIE, equity method
|
Fabrus
|
|
|
650
|
|
|
VIE, equity method
|
TESARO
|
|
|
731
|
|
|
VIE, cost method
|
Less accumulated losses in investees
|
|
|
(1,490
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
4,691
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 6 FAIR VALUE MEASUREMENTS
We record fair value at an exit price, representing the amount that would be received to sell
an asset or paid to transfer a liability in an orderly transaction between market participants. As
such, fair value is a market-based measurement that should be determined based on assumptions that
market participants would use in pricing an asset or liability. We utilize 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, 2011, we held money market funds and treasury securities that qualify as cash
equivalents, marketable securities that consist of treasury securities, forward contracts for
inventory purchases (Refer to Note 7) and contingent consideration related to the acquisition of
CURNA (Refer to Note 5) that are required to be measured at fair value on a recurring basis. As of
March 31, 2011, we held money market funds and treasury securities totaling $46.9 million,
including treasury securities maturing June 9, 2011 and June 23, 2011, that qualify as cash
equivalents as well as marketable securities which were comprised entirely of treasury securities
totaling $60.0 million, maturing June 30, 2011, July 14, 2011, and July 21, 2011, that are required
to be measured at fair value on a recurring basis. The $85.0 million of treasury securities are
recorded at amortized cost, which reflects their approximate fair value. Our other assets and
liabilities carrying value approximate their fair value due to their short-term nature.
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 or loss. If we determine that any future valuation adjustment was
other-than-temporary, we would record a charge to the consolidated statement of operations as
appropriate.
15
Our financial assets and liabilities measured at fair value on a recurring basis are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value measurements as of March 31, 2011
|
|
|
|
Quoted prices
|
|
|
|
|
|
|
|
|
|
|
|
|
in active
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
markets for
|
|
|
other
|
|
|
Significant
|
|
|
|
|
|
|
identical
|
|
|
observable
|
|
|
unobservable
|
|
|
|
|
|
|
assets
|
|
|
inputs
|
|
|
inputs
|
|
|
|
|
(in thousands)
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Total
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
21,944
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
21,944
|
|
Treasury securities
|
|
|
84,979
|
|
|
|
|
|
|
|
|
|
|
|
84,979
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
106,923
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
106,923
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forward contracts
|
|
$
|
|
|
|
$
|
340
|
|
|
$
|
|
|
|
$
|
340
|
|
CURNA contingent
considerations
|
|
|
|
|
|
|
|
|
|
|
580
|
|
|
|
580
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
$
|
|
|
|
$
|
340
|
|
|
$
|
580
|
|
|
$
|
920
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 7 DERIVATIVE CONTRACTS
We enter into foreign currency forward exchange contracts to cover the risk of exposure to
exchange rate differences arising from inventory purchases on letters of credit. Under these
forward contracts, for any rate above or below the fixed rate, we receive or pay the difference
between the spot rate and the fixed rate for the given amount at the settlement date.
We record derivative financial instruments on our balance sheet at their fair value as an
accrued expense and the changes in the fair value are recognized in income in other expense net
when they occur, the only exception being derivatives that qualify as hedges. To qualify the
derivative instrument as a hedge, we are required to meet strict hedge effectiveness and
contemporaneous documentation requirements at the initiation of the hedge and assess the hedge
effectiveness on an ongoing basis over the life of the hedge. At March 31, 2011, the forward
contracts did not meet the documentation requirements to be designated as hedges. Accordingly, we
recognize all changes in fair values in income.
The outstanding contracts at March 31, 2011, have been recorded at fair value, and their
maturity details are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
|
|
|
|
|
Fair value at
|
|
|
Effect on gain
|
|
Days until maturity
|
|
Contract value
|
|
|
March 31, 2011
|
|
|
(loss)
|
|
0 to 30
|
|
$
|
1,722
|
|
|
$
|
1,912
|
|
|
$
|
(190
|
)
|
31 to 60
|
|
|
1,177
|
|
|
|
1,233
|
|
|
|
(56
|
)
|
61 to 90
|
|
|
784
|
|
|
|
866
|
|
|
|
(82
|
)
|
91 to 120
|
|
|
|
|
|
|
|
|
|
|
|
|
121 to 180
|
|
|
186
|
|
|
|
191
|
|
|
|
(5
|
)
|
More than 180
|
|
|
193
|
|
|
|
200
|
|
|
|
(7
|
)
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
4,062
|
|
|
$
|
4,402
|
|
|
$
|
(340
|
)
|
|
|
|
|
|
|
|
|
|
|
NOTE 8 RELATED PARTY TRANSACTIONS
On March 14, 2011, we issued 27,000,000 shares of our Common Stock. Refer to Note 11. The
27,000,000 shares of our Common Stock issued include an aggregate of 3,733,000 shares of our Common
Stock purchased by the Gamma Trust and Hsu Gamma at the public offering price. The Gamma Trust
purchased an aggregate of 3,200,000 shares for approximately $12 million, and Hsu Gamma purchased
an aggregate of 533,000 shares for approximately $1.9 million. Jefferies & Company, Inc. and J.P.
Morgan Securities LLC acted as joint book-running
managers for the offering. UBS Investment Bank and Lazard Capital Markets LLC acted as
co-lead managers for
16
the offering and Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg
Thalmann Financial Services Inc., acted as co-manager for the offering. Dr. Frost is the Chairman
of the Board of Directors and principal shareholder of Ladenburg Thalmann Financial Services Inc.
On January 28, 2011, we entered into a definitive agreement with CURNA and each of CURNAs
stockholders and optionholders, pursuant to which we agreed to acquire all of the outstanding stock
of CURNA in exchange for $10.0 million in cash, plus $0.6 million in liabilities, of which
$0.5 million was paid at closing. At the time of the transaction, The Scripps Research Institute
(TSRI) owned approximately 4% of CURNA. Dr. Frost serves as Trustee for TSRI and Richard Lerner
is its President.
We have a $12.0 million line of credit with the Frost Group. On June 2, 2010 we repaid all
amounts outstanding on the line of credit including $12 million in principal and $4.1 million in
interest. The line of credit, which previously expired on January 11, 2011, was renewed on
February 22, 2011 until March 31, 2012 on substantially the same terms as those in effect at the
time of expiration. We have the ability to draw funds under the line of credit until its
expiration in March 2012. We are obligated to pay interest upon maturity, capitalized quarterly,
on outstanding borrowings under the line of credit at an 11% annual rate. The line of credit is
collateralized by all of our U.S. personal property except our intellectual property.
In November 2010, we made an investment in Fabrus, a privately held early stage biotechnology
company with next generation therapeutic antibody drug discovery and development capabilities. In
exchange for the investment, we acquired approximately 13% of Fabrus outstanding membership
interests on a fully diluted basis. Our investment was part of a $2.1 million financing for
Fabrus. Other investors participating in the financing include the Gamma Trust and Hsu Gamma. In
connection with the financing, Drs. Frost and Hsiao joined the Fabrus Board of Managers. Dr.
Richard Lerner, a director of the Company, owns approximately 5% of Fabrus. Vaughn Smider, Founder
and CEO of Fabrus, is an Assistant Professor at TSRI. Dr. Frost serves as a Trustee for TSRI, and
Richard Lerner serves as its President.
On July 20, 2010, we entered into a use agreement with TRSI for approximately 1,100 square
feet of space in Jupiter, Florida to house our molecular diagnostics operations. Dr. Frost serves
as a trustee for TSRI and Richard Lerner serves as its president. Pursuant to the terms of the use
agreement, which is effective as of November 1, 2009, gross rent is approximately $40 thousand per
year for a two-year term which may be extended upon mutual agreement for one additional year.
On June 1, 2010, the Company entered into a cooperative research and development agreement
with Academia Sinica in Taipei, Taiwan (Academia Sinica), for pre-clinical work for a compound
against various forms of cancer. Dr. Alice Yu, a member of our board of directors, is a
Distinguished Research Fellow and Associate Director at the Genomics Research Center, Academia
Sinica (Genomics Research Center). In connection with the agreement, we are required to pay
Academia Sinica approximately $0.2 million over the term of the agreement.
Effective March 5, 2010, the Frost Group assigned two license agreements with Academia Sinica
to the Company. The license agreements pertain to alpha-galactosyl ceramide analogs and their use
as immunotherapies and peptide ligands in the diagnosis and treatment of cancer. In connection
with the assignment of the two licenses, the Company agreed to reimburse the Frost Group for the
licensing fees previously paid by the Frost Group to Academia Sinica in the amounts of $50 thousand
and $75 thousand, respectively, as well as reimbursement of certain expenses of $50 thousand.
Effective September 21, 2009, we entered into an agreement pursuant to which we invested $2.5
million in Cocrystal in exchange for 1,701,723 shares of Cocrystals Convertible Series A Preferred
Stock. A group of investors, led by the Frost Group (the CoCrystal Investors), previously
invested $5 million in Cocrystal, and agreed to invest an additional $5 million payable in two
equal installments in September 2009 and March 2010. As a result of an amendment to the CoCrystal
Investors agreements dated June 9, 2009, OPKO, rather than the CoCrystal Investors, made the first
installment investment ($2.5 million) on September 21, 2009. Refer to Note 5.
On July 20, 2009, we entered into a worldwide exclusive license agreement with Academia Sinica
in Taipei, Taiwan, for a new technology to develop protein vaccines against influenza and other
viral infections. Dr. Alice Yu, a member of our board of directors, is a Distinguished Research
Fellow and Associate Director at the Genomics Research Center. In connection with the license, the
Company paid to Academia Sinica an upfront licensing fee and agreed to pay royalties and other
payments on the occurrence of certain development milestones.
17
On June 16, 2009, we entered into an agreement to lease approximately 10,000 square feet of
space in Hialeah, Florida to house manufacturing and service operations for our ophthalmic
instrumentation business (the Hialeah Facility) from an entity controlled by Dr. Frost and Dr.
Jane Hsiao. Pursuant to the terms of a lease agreement, which is effective as of February 1, 2009,
gross rent is $0.1 million per year for a one-year lease and was extended through February 1, 2011.
On June 10, 2009, we entered into a stock purchase agreement with Sorrento, pursuant to which
we invested $2.3 million in Sorrento. Refer to Note 5. In exchange for the investment, we
acquired approximately one-third of the outstanding common shares of Sorrento and received a
fully-paid, exclusive license to the Sorrento antibody library for the discovery and development of
therapeutic antibodies in the field of ophthalmology. On September 21, 2009, Sorrento entered into
a merger transaction with Quikbyte Software, Inc. Prior to the merger transaction, certain
investors, including Dr. Frost and other members of OPKO management, made an investment in
Quikbyte. Dr. Richard Lerner, a member of our Board of Directors, serves as a consultant and
scientific advisory board member to Sorrento and owns less than one percent of its shares.
In November 2007, we entered into an office lease with Frost Real Estate Holdings, LLC, an
entity affiliated with Dr. Frost. The lease is for approximately 8,300 square feet of space in an
office building in Miami, Florida, where the Companys principal executive offices are located.
The lease provides for payments of approximately $18 thousand per month in the first year
increasing annually to $24 thousand per month in the fifth year, plus applicable sales tax. The
rent is inclusive of operating expenses, property taxes and parking. The rent for the first year
was reduced to reflect a $30 thousand credit for the costs of tenant improvements.
On September 19, 2007, we entered into an exclusive technology license agreement with Winston
Laboratories, Inc. (Winston). On February 23, 2010, we provided Winston notice of termination of
the license agreement, and the agreement terminated on May 24, 2010. Previously, members of the
Frost Group beneficially owned approximately 30% of Winston Pharmaceuticals, Inc., and Dr.
Uppaluri, our Chief Financial Officer, served as a member of Winstons board. Effective May 19,
2010, the members of the Frost Group sold 100% of Winstons capital stock beneficially owned by
them (consisting of an aggregate of 18,399,271 outstanding shares of common stock and warrants to
purchase an aggregate of 8,958,975 shares of common stock) to an entity whose members include Dr.
Joel E. Bernstein, the President and Chief Executive Officer of Winston. As consideration for the
sale, the Frost Group members received an aggregate of $789,500 in cash and non-recourse promissory
notes in the aggregate principal amount of $10,263,500. Dr. Uppaluri resigned from the Winston
board effective May 19, 2010. In connection with the license agreement, we reimbursed Winston $29
thousand, and $3 thousand in the years ended December 31, 2009 and 2008, respectively, for services
provided by Winston personnel to assist us with the clinical program for the product we licensed.
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. For the three months ended
March 31, 2011 and 2010, we reimbursed Dr. Frost approximately $57 thousand and $18 thousand,
respectively, for Company-related travel by Dr. Frost and other OPKO executives.
NOTE 9 COMMITMENTS AND CONTINGENCIES
In connection with our acquisition of CURNA, we agreed to pay a portion of future
consideration to the CURNA sellers if we license or partner the CURNA technology with a third party
including, license fees, upfront payments, royalties and milestone payments. As a result, we
recorded $0.6 million, as contingent consideration for the future consideration. Refer to Note 5.
On January 7, 2010, we received a letter from counsel to Nidek Co., Ltd. (Nidek) alleging
that Ophthalmic Technologies, Inc. (OTI) or OPKO breached its service obligations to Nidek under
the Service Agreement between OTI, Nidek and Newport Corporation, dated December 29, 2006, and the
Service Agreement by and between Nidek and OTI, dated the same date. We entered into a settlement
agreement in April 2011 which resolved all disputes between the Company and Nidek and released us
from any future service obligation to Nidek. The settlement did not have a material impact on our
results of operations or financial condition.
On May 6, 2008, we completed the acquisition of Vidus Ocular, Inc. (Vidus). Pursuant to a
Securities Purchase Agreement with Vidus, each of its stockholders, and the holders of convertible
promissory notes issued by
18
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 our Common Stock.
We are a party to other 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.
NOTE 10 SEGMENTS
We currently manage our operations in two reportable segments, pharmaceutical and
instrumentation segments. The pharmaceutical segment consists of two operating segments, our (i)
pharmaceutical research and development segment which is focused on the research and development of
pharmaceutical products, diagnostic tests and vaccines, and (ii) the pharmaceutical operations we
acquired in Chile and Mexico through the acquisition of OPKO Chile and Exakta-OPKO. The
instrumentation segment consists of ophthalmic instrumentation products and the activities related
to the research, development, manufacture and commercialization of those products. There are no
inter-segment sales. We evaluate the performance of each segment based on operating profit or
loss. There is no inter-segment allocation of interest expense and income taxes.
Information regarding our operations and assets for the two segments and the unallocated
corporate operations as well as geographic information are as follows:
19
|
|
|
|
|
|
|
|
|
|
|
For the three months ended
|
|
|
|
March 31,
|
|
(in thousands)
|
|
2011
|
|
|
2010
|
|
Product sales
|
|
|
|
|
|
|
|
|
Pharmaceutical
|
|
$
|
6,937
|
|
|
$
|
5,312
|
|
Instrumentation
|
|
|
1,698
|
|
|
|
2,610
|
|
|
|
|
|
|
|
|
|
|
$
|
8,635
|
|
|
$
|
7,922
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
|
|
|
|
|
|
Pharmaceutical
|
|
$
|
(1,019
|
)
|
|
$
|
(644
|
)
|
Instrumentation
|
|
|
(955
|
)
|
|
|
(936
|
)
|
Corporate
|
|
|
(3,112
|
)
|
|
|
(2,486
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(5,086
|
)
|
|
$
|
(4,066
|
)
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
|
|
|
|
|
|
Pharmaceutical
|
|
$
|
824
|
|
|
$
|
514
|
|
Instrumentation
|
|
|
130
|
|
|
|
444
|
|
Corporate
|
|
|
43
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
$
|
997
|
|
|
$
|
971
|
|
|
|
|
|
|
|
|
Product sales
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
264
|
|
|
$
|
197
|
|
Chile
|
|
|
5,756
|
|
|
|
4,937
|
|
Mexico
|
|
|
1,199
|
|
|
|
401
|
|
All others
|
|
|
1,416
|
|
|
|
2,387
|
|
|
|
|
|
|
|
|
|
|
$
|
8,635
|
|
|
$
|
7,922
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
|
March 31,
|
|
|
December
|
|
|
|
2011
|
|
|
31, 2010
|
|
Assets
|
|
|
|
|
|
|
|
|
Pharmaceutical
|
|
$
|
59,503
|
|
|
$
|
51,599
|
|
Instrumentation
|
|
|
9,126
|
|
|
|
8,637
|
|
Corporate
|
|
|
107,678
|
|
|
|
17,610
|
|
|
|
|
|
|
|
|
|
|
$
|
176,307
|
|
|
$
|
77,846
|
|
|
|
|
|
|
|
|
During the three months ended March 31, 2011, our largest customer represented 12% of our
total revenue. During the three months ended March 31, 2010, our two largest customers
represented 17%, and 10%, respectively, of our revenue. As of March 31, 2011, one customer
represented 30% of our accounts receivable balance. As of December 31, 2010, two customers
represented 32% and 11%, respectively, of our accounts receivable balance.
NOTE 11 ISSUANCE OF COMMON STOCK
On March 14, 2011, we issued 27,000,000 shares of our Common Stock in a public offering at a
price of $3.75 per share. We also granted the underwriters a 30-day option to purchase up to an
additional 4,050,000 shares of our Common Stock to cover overallotments, if any. On March 15,
2011, representatives for the underwriters provided us notice that the underwriters exercised a
portion of their 4,050,000 share over-allotment option for 2,397,029 additional shares of our
Common Stock.
The following table reflects the proceeds received from the issuance of shares:
|
|
|
|
|
|
|
|
|
(in thousands, except share amounts)
|
|
Shares
|
|
|
Dollars
|
|
Original issuance
|
|
|
27,000,000
|
|
|
$
|
101,250
|
|
Over-allotment
|
|
|
2,397,029
|
|
|
|
8,989
|
|
|
|
|
|
|
|
|
Total
|
|
|
29,397,029
|
|
|
|
110,239
|
|
|
|
|
|
|
|
|
|
Underwriters discount and commissions
(1)
|
|
5.5% on 24,064,029 shares
|
|
|
(4,963
|
)
|
Offering expenses
|
|
|
|
|
|
|
(448
|
)
|
|
|
|
|
|
|
|
|
Net proceeds
|
|
|
|
|
|
$
|
104,828
|
|
|
|
|
|
|
|
|
|
20
|
|
|
(1)
|
|
The underwriters will not receive any underwriting discount or commissions on
the sale of 5,333,000 shares of common stock to entities associated with certain stockholders,
including two of our directors and executive officers. Refer to Note 8.
|
NOTE 12 SUBSEQUENT EVENTS
On or about May 3, 2011, we initiated the redemption of our Series A Preferred Stock. Holders
of our Series A Preferred Stock have until May 30, 2011 to elect to convert their Series A
Preferred Shares into shares of our Common Stock, which convert on a 1:1 basis. The closing price
of our Common Stock on May 2, 2011 was $3.91. On June 3, 2011, we will redeem all of our
outstanding Series A Preferred Stock for their redemption amount of $2.50, plus unpaid accrued
dividends of $0.35 per share. As of March 31, 2011 there were 722,700 shares of our Series A
Preferred Stock outstanding, resulting in a potential cash payment of approximately $2.1 million if
all of the Series A Preferred Stock remain outstanding as of June 3, 2011.
We have reviewed all subsequent events and transactions that occurred after the date of our
March 31, 2011 consolidated balance sheet date, through the time of filing this Quarterly Report on
Form 10-Q.
21
Item 2.
Managements Discussion and Analysis of Financial Condition and Results of
Operations
OVERVIEW
You should read this discussion together with the condensed consolidated 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, 2010 (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
for the year ended December 31, 2010. These risks could cause our actual
results to differ materially from those anticipated in these forward-looking statements.
We are a multi-national pharmaceutical and diagnostics company that seeks to establish
industry-leading positions in large and rapidly growing medical markets by leveraging our
discovery, development and commercialization expertise and our novel and proprietary technologies.
Our current focus is on conditions with major unmet medical needs including neurological disorders,
infectious diseases, oncology and ophthalmologic diseases. We are developing a range of solutions
to diagnose, treat and prevent these conditions, including molecular diagnostics tests, proprietary
pharmaceuticals and vaccines. We plan to commercialize these solutions on a global basis in large
and high growth markets, including emerging markets. We have already established emerging markets
pharmaceutical platforms in Chile and Mexico, which are delivering revenue and which we expect to
deliver cash flow and facilitate future market entry for our products currently in development. We
also actively explore opportunities to acquire complementary pharmaceuticals, compounds,
technologies, and businesses.
We expect to incur substantial losses as we continue the development of our product
candidates, continue our other research and development activities, and establish a sales and
marketing infrastructure in anticipation of the commercialization of our diagnostic and
pharmaceutical product candidates. We currently have limited commercialization capabilities, and
it is possible that we may never successfully commercialize any of our diagnostic and
pharmaceutical product candidates. We do not currently generate revenue from any of our diagnostic
and pharmaceutical product candidates. Our research and development activities are budgeted to
expand over a period of 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 may 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 when needed
on acceptable terms, or at all.
RECENT DEVELOPMENTS
On March 14, 2011, we issued 27,000,000 shares of our Common Stock in a public offering at a
price of $3.75 per share. We also granted the underwriters a 30-day option to purchase up to an
additional 4,050,000 shares of our Common Stock to cover overallotments, if any. On March 15,
2011, representatives for the underwriters provided us notice that the underwriters exercised a
portion of their 4,050,000 share over-allotment option for 2,397,029 additional shares of our
Common Stock. We received approximately $104.8 million in net proceeds from the issuance of
29,397,029 shares of our Common Stock after deducting the underwriters discounts and commissions
and other estimated offering expenses.
On January 31, 2011, we acquired all of the outstanding stock of CURNA, Inc. (CURNA), a
privately held therapeutics company, in exchange for $10.0 million in cash, plus $0.6 million in liabilities, of which, $0.5 million was paid at closing. In addition to the cash
consideration, we have agreed to pay to the CURNA sellers a portion of any consideration we receive
in connection with certain license, partnership or collaboration agreements we may enter into with
third parties in the future relating to the CURNA technology, including, license fees, upfront
payments, royalties and milestone payments. CURNA is engaged in the discovery of new drugs for the
treatment of a wide variety of illnesses, including cancer, heart disease, metabolic disorders and
a range of genetic anomalies.
RESULTS OF OPERATIONS
FOR THE THREE MONTHS ENDED MARCH 31, 2011 AND 2010
Revenue.
Revenue for the three months ended March 31, 2011, was $8.6 million, compared to
$7.9 million for the comparable 2010 period. The increase in revenue during the first three months
of 2011 is primarily due to revenue from our OPKO Chile and Exakta-OPKO pharmaceutical businesses.
We acquired Exakta-OPKO in February 2010, and as a result, the 2010 period reflects revenue only
after the acquisition occurred. Revenue from
22
our instrumentation business decreased from the 2010
period, primarily as a result of decreased demand from our international customers for our OCT/SLO
product.
Gross margin.
Gross margin for the three months ended March 31, 2011, was $3.0 million
compared to $2.4 million for the comparable period of 2010. Gross margin for the three months
ended March 31, 2011, increased from the 2010 period primarily as a result of the increased gross
margin generated by our pharmaceutical businesses in Chile and Mexico, partially offset by
decreased revenue and resulting decreased gross margin generated by our instrumentation business.
Selling, general and administrative expense.
Selling, general and administrative expense for
the three months ended March 31, 2011, was $5.6 million compared to $4.2 million of expense for the
comparable period of 2010. The increase in selling, general and administrative expenses is
primarily the result of increased warehousing and distribution costs for our Chilean operations,
increased equity based compensation expense and a full period of selling, general and
administrative expenses for our operations in Mexico. Selling, general and administrative expenses
during the first three months of 2011 and 2010 primarily include personnel expenses, including
equity-based compensation expense of $1.4 million and $1.0 million, respectively, and professional
fees.
Research and development expense.
Research and development expense during the three months
ended March 31, 2011 and 2010, was $1.6 million and $1.3 million, respectively. The increase in
research and development expense primarily is the result of increased personnel expenses including
equity based compensation expense. The three months ended March 31, 2011 and 2010, include
equity-based compensation expense of $0.4 million and $0.2 million, respectively. During the three
months ended March 31, 2011, research and development expense primarily consisted of activities
related to our molecular diagnostics development program, research and development expense for our
instrumentation business including the development of next generation devices, and development of
the technology acquired from CURNA. Research and development expense for the three month period
ended March 31, 2010 primarily included activities related to our rolapitant development program,
which we out licensed in December 2010, our molecular diagnostics development program and research
and development activities for our instrumentation business.
Other operating expenses.
Other operating expenses was $0.9 million for the three months
ended March 31, 2011 and March 31, 2010. Other operating expenses primarily include the
amortization of intangible assets. Amortization expense during the three months ended March 31,
2011 includes the amortization expense of the CURNA intangible assets acquired in January 2011,
offset by a portion of the OTI intangible assets that fully amortized in November 2010.
Other income and expenses.
Other income, net was $38 thousand for the first three months of
2011 compared to other expense, net of $0.3 million for the comparable 2010 period. Other income
primarily consists of interest earned on our cash and cash equivalents and other expense primarily
reflects the interest incurred on our line of credit with The Frost Group LLC (the Frost Group).
On June 2, 2010, we repaid all amounts outstanding on the Frost Group line of credit including $12.0
million in principal and $4.1 million in interest. The Frost Group members include a trust
controlled by Dr. Frost, who is the Companys 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.
Income taxes.
Our income tax provision reflects the income tax payable in Chile and Mexico.
We have recorded a full valuation allowance against our deferred tax assets in the U.S.
LIQUIDITY AND CAPITAL RESOURCES
At March 31, 2011, we had cash, cash equivalents and marketable securities of approximately
$107.9 million. Cash used in operations during 2011 primarily reflects expenses related to
research and development activities, selling, general and administrative activities related to our
corporate and instrumentation operations, as well as our operations in Chile and Mexico. Since our
inception, we have not generated sufficient gross margins to offset our operating and other
expenses and our primary source of cash has been from the sale of our stock and credit facilities
available to us.
On March 14, 2011, we issued 27,000,000 shares of our Common Stock in a public offering at a
price of $3.75 per share. We also granted the underwriters a 30-day option to purchase up to an
additional 4,050,000 shares of our Common Stock to cover overallotments, if any. On March 15,
2011, representatives for the underwriters provided
23
us notice that the underwriters exercised a
portion of their 4,050,000 share over-allotment option for 2,397,029 additional shares of our
Common Stock. We received approximately $104.8 million, net, from the issuance of 29,397,029
shares of our Common Stock.
On January 31, 2011, we acquired all of the outstanding stock of CURNA in exchange for $10.0
million in cash, plus $0.6 million in liabilities, of which, $0.5 million was paid at
closing. In addition to the cash consideration, we have agreed to pay to the CURNA sellers a
portion of any consideration we receive in connection with certain license, partnership or
collaboration agreements we may enter into with third parties in the future relating to the CURNA
technology, including, license fees, upfront payments, royalties and milestone payments. As a
result, we recorded $0.6 million, as contingent consideration for the future consideration. CURNA
is engaged in the discovery of new drugs for the treatment of a wide variety of illnesses,
including cancer, heart disease, metabolic disorders and a range of genetic anomalies.
We have outstanding lines of credit in the aggregate amount of $18.9 million with seven
financial institutions in Chile, of which, $4.3 million is unused. These lines of credit are used
primarily as a source of working capital and for inventory purchases. The average interest rate
on these lines of credit is approximately 3%. These lines of credit are short term and are
generally due within three months. The highest balance at any time during the three months ended
March 31, 2011, was $14.8 million. We intend to continue to enter into these lines of credit as
needed. There is no assurance that this or other funding sources will be available to us on
acceptable terms, or at all.
We currently have an unutilized $12.0 million line of credit with the Frost Group. The line
of credit, which previously expired on January 11, 2011, was renewed on February 22, 2011 on
substantially the same terms as those in effect at the time of expiration. We are obligated to pay
interest upon maturity, capitalized quarterly, on outstanding borrowings under the line of credit
at an 11% annual rate, which is due March 31, 2012. The line of credit is collateralized by all of
our U.S. based personal property except our intellectual property.
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 believe the cash, cash equivalents, and marketable securities on hand at March 31, 2011 and
the amounts available to be borrowed under our lines of credit are sufficient to meet our
anticipated cash requirements for operations and debt service beyond the next 12 months. We based
this estimate on assumptions that may prove to be wrong or are subject to change, and we may be
required to use our available cash resources sooner than we currently expect. If we acquire
additional assets or companies, accelerate our product development programs or initiate additional
clinical trials, we will need additional funds. Our future cash requirements will depend on a
number of factors, including possible acquisitions, the continued progress of research and
development of our 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,
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 available cash on hand, payments from potential strategic
research and development, licensing and/or marketing arrangements, public offerings, private
placements, debt financing and revenues from future product sales, if any. There can be no
assurance, however, 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.
Equity-based compensation
. We recognize equity based compensation as an expense in our
financial statements and that cost is measured at the fair value of the award and expensed over
their vesting period. Equity-based compensation arrangements to non-employees are recorded at
their fair value on the measurement date. We
24
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. 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. 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 research and development
projects, projecting regulatory approvals, estimating future cash flows, and developing appropriate
discount rates. We believe the estimated fair values assigned to the CURNA 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, which is up to one
year from the acquisition date, if additional information becomes available that would require
changes to our estimates.
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
managements evaluation of specific factors that may increase the risk of product returns. We
analyze accounts receivable and historical bad debt levels, customer credit worthiness and current
economic trends when evaluating the adequacy of the allowance for doubtful accounts using
the specific identification method. Our reported net loss is directly affected by
managements estimate of the collectability of accounts receivable. The allowance for doubtful
accounts recognized in our consolidated balance sheets at March 31, 2011 and December 31, 2010 was
$1.2 million and $1.2 million, respectively.
Recent accounting pronouncements
. In December 2010, the FASB issued an amendment to the
disclosure of supplementary pro forma information for business combinations. The amendment
specifies that if a public entity presents comparative financial statements, the entity should
disclose revenue and earnings of the combined entity as though the business combination(s) that
occurred during the current year had occurred as of the beginning of the comparable prior annual
reporting period only. The amendment also expands the supplemental pro forma disclosures under
current accounting guidance to include a description of the nature and amount of material,
nonrecurring pro forma adjustments directly attributable to the business combination included in
the reported pro forma revenue and earnings. The amendment is effective prospectively for business
combinations for which the acquisition date is on or after the beginning of the first annual
reporting period beginning on or after December 15, 2010. The adoption of this amendment did not
have a material impact on our financial statement disclosures.
In December 2010, the FASB issued an amendment to the accounting for goodwill impairment
tests. The amendment modifies Step 1 of the impairment test for reporting units with zero or
negative carrying amounts. For those reporting units, an entity is required to perform Step 2 of
the goodwill impairment test if it is more likely than not that a goodwill impairment exists. In
determining whether it is more likely than not that a goodwill impairment exists, an entity should
consider whether there are any adverse qualitative factors indicating that an impairment may exist.
The qualitative factors are consistent with the existing guidance. The amendment is effective for
fiscal years, and interim periods within those years, beginning after December 15, 2010. The
adoption of this amendment did not have a material impact on our results of operations or financial
condition.
25
In December 2010, the FASB issued an amendment to the accounting for annual excise taxes paid
to the federal government by pharmaceutical manufacturers under health care reform. The liability
for the fee should be estimated and recorded in full upon the first qualifying branded prescription
drug sale with a corresponding deferred cost that is amortized to expense using a straight-line
method of allocation unless another method better allocates the fee over the calendar year that it
is payable. The amendment is effective for calendar years beginning after December 31, 2010, when
the fee initially becomes effective. As we currently do not manufacture pharmaceutical products in
the United States, we do not expect the adoption of this amendment to have a material impact on our
results of operations or financial condition.
In March 2010, the FASB reached a consensus to issue an amendment to the accounting for
revenue arrangements under which a vendor satisfies its performance obligations to a customer over
a period of time, when the deliverable or unit of accounting is not within the scope of other
authoritative literature, and when the arrangement consideration is contingent upon the achievement
of a milestone. The amendment defines a milestone and clarifies whether an entity may recognize
consideration earned from the achievement of a milestone in the period in which the milestone is
achieved. This amendment is effective for fiscal years beginning on or after June 15, 2010, with
early adoption permitted. We adopted this amendment prospectively for milestones achieved after
January 1, 2011. This amendment did not have a material impact on our results of operation or
financial condition.
In October 2009, the FASB issued an amendment to the accounting for multiple-deliverable
revenue arrangements. This amendment provides guidance on whether multiple deliverables exist, how
the arrangements should be separated, and how the consideration paid should be allocated. As a
result of this amendment, entities may be able to separate multiple-deliverable arrangements in
more circumstances than under existing accounting guidance. This guidance amends the requirement
to establish the fair value of undelivered products and services based on objective evidence and
instead provides for separate revenue recognition based upon managements best estimate of the
selling price for an undelivered item when there is no other means to determine the fair value of
that undelivered item. The existing guidance previously required that the fair value of the
undelivered item reflect the price of the item either sold in a separate transaction between
unrelated third parties or the price charged for each item when the item is sold separately by the
vendor. If the fair value of all of the elements in the arrangement was not determinable,
then revenue was deferred until all of the items were delivered or fair value was determined.
We adopted this amendment prospectively for revenue arrangements entered into or materially
modified after January 1, 2011. This amendment did not have a material impact on our results of
operation or financial condition.
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.
Foreign Currency Exchange Rate Risk Although we do not speculate in the foreign exchange
market, we may from time to time manage exposures that arise in the normal course of business
related to fluctuations in foreign currency exchange rates by entering into offsetting positions
through the use of foreign exchange forward contracts. Certain firmly committed transactions are
hedged with foreign exchange forward contracts. As exchange rates change, gains and losses on the
exposed transactions are partially offset by gains and losses related to the hedging contracts.
Both the exposed transactions and the hedging contracts are translated at current spot rates, with
gains and losses included in earnings.
Our derivative activities, which consist of foreign exchange forward contracts, are initiated
to hedge forecasted cash flows that are exposed to foreign currency risk. The foreign exchange
forward contracts generally require us to exchange local currencies for foreign currencies based on
pre-established exchange rates at the contracts maturity dates. As exchange rates change, gains
and losses on these contracts are generated based on the change in the exchange rates that are
recognized in the consolidated statement of operations at maturity, and offset the impact of the
change in exchange rates on the foreign currency cash flows that are hedged. If the counterparties
to the exchange contracts do not fulfill their obligations to deliver the contracted currencies, we
could be at risk for currency related fluctuations. We enter into these contracts with
counterparties that we believe to be creditworthy and do not enter into any leveraged derivative
transactions. We had $4.1 million in foreign exchange forward contracts outstanding at March 31,
2011, primarily to hedge Chilean-based operating cash flows against US dollars. If Chilean Pesos
were to strengthen in relation to the US dollar, our hedged foreign currency cash-flows expense
would be offset by a loss on the derivative contracts, with a net effect of zero.
26
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.
Interest Rate 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 treasury securities.
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, 2011, we had
cash, cash equivalents and marketable securities of $107.9 million. The weighted average interest
rate related to our cash and cash equivalents for the three months ended March 31, 2011 was 0%. As
of March 31, 2011, the principal value of our credit lines was $14.6 million, and have a weighted
average interest rate of approximately 3%.
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 4.
Controls and Procedures
The Companys management, under the supervision and with the participation of the Companys
Chief Executive Officer (CEO) and Chief Financial Officer (CFO), has evaluated the
effectiveness of the Companys disclosure controls and procedures as defined in Securities and
Exchange Commission (SEC) Rule 13a-15(e) as of March 31, 2011. Based on that evaluation, CEO and
CFO have concluded that the Companys 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 accumulated and 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 SECs rules and forms.
There have been no changes to the Companys internal control over financial reporting that
occurred during the Companys first quarter of 2011 that have materially affected, or are
reasonably likely to materially affect, the Companys internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
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.
Item 1A.
Risk Factors
There have been no material changes from the risk factors as previously disclosed in the Item
1A of the Company Annual Report on Form 10-K.
27
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3.
Defaults Upon Senior Securities
None.
Item 4.
(Removed and Reserved)
Item 5.
Other Information
None.
Item 6.
Exhibits
.
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Exhibit 1.1
(7)
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Underwriting Agreement dated March 9, 2011, by and
among OPKO Health, Inc., Jefferies & Company, Inc. and
J.P. Morgan Securities LLC, as representatives for the
underwriters named therein.
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Exhibit 2.1
(1)
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Merger Agreement and Plan of Reorganization,
dated as of March 27, 2007, by and among Acuity
Pharmaceuticals, Inc., Froptix Corporation, eXegenics,
Inc., e-Acquisition Company I-A, LLC, and
e-Acquisition Company II-B, LLC.
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Exhibit 2.2
(4)+
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Securities Purchase Agreement dated May 6, 2008,
among Vidus Ocular, Inc., OPKO Instrumentation, LLC,
OPKO Health, Inc., and the individual sellers and
noteholders named therein.
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Exhibit 2.3
(8)
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Purchase Agreement, dated February 17, 2010, among
Ignacio Levy García and José de Jesús Levy García,
Inmobiliaria Chapalita, S.A. de C.V., Pharmacos
Exakta, S.A. de C.V., OPKO Health, Inc., OPKO Health
Mexicana S. de R.L. de C.V., and OPKO Manufacturing
Facilities S. de R.L. de C.V.
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Exhibit 2.4
+
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Agreement and Plan of Merger, dated January 28, 2011,
among CURNA Inc., KUR, LLC, OPKO Pharmaceuticals, LLC,
OPKO CURNA, LLC, and certain individuals named
therein.
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Exhibit 3.1
(2)
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Amended and Restated Certificate of Incorporation.
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Exhibit 3.2
(3)
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Amended and Restated By-Laws.
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Exhibit 4.1
(1)
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Form of Common Stock Warrant.
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Exhibit 10.1
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Amendment No. 2 to the Credit Agreement dated March
27, 2007, as amended, with the Frost Group, LLC.
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Exhibit 10.2
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Third Amended and Restated Subordinated Note and
Security Agreement, dated February 22, 2011, with the
Frost Group, LLC.
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Exhibit 31.1
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Certification by Phillip Frost, Chief Executive
Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of
the Securities and Exchange Act of 1934 as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 for the quarterly period ended March 31, 2011.
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Exhibit 31.2
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Certification by Rao Uppaluri, Chief Financial
Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of
the Securities and Exchange Act of 1934 as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 for the quarterly period ended March 31, 2011.
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28
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Exhibit 32.1
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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 for the quarterly period ended March 31, 2011.
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Exhibit 32.2
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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 for the quarterly period ended March 31, 2011.
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+
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Certain confidential material contained in the
document has been omitted and filed separately with
the Securities and Exchange Commission.
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(1)
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Filed with the Companys Current Report on Form 8-K
filed with the Securities and Exchange Commission on
April 2, 2007, and incorporated herein by reference.
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(2)
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Filed with the Companys Current Report on Form 8-A
filed with the Securities and Exchange Commission on
June 11, 2007, and incorporated herein by reference.
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(3)
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Filed with the Companys Annual Report on Form 10-K
filed with the Securities and Exchange Commission on
March 31, 2008 and incorporated herein by reference.
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(4)
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Filed with the Companys Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission on
August 8, 2008 for the Companys three-month period
ended June 30, 2008, and incorporated herein by
reference.
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(6)
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Filed with the Companys Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission on
November 12, 2008 for the Companys three-month period
ended September 30, 2008, and incorporated herein by
reference.
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(7)
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Filed with the Companys Current Report on Form 8-K
filed with the Securities and Exchange Commission on
March 10, 2011, and incorporated herein by reference.
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(8)
|
|
Filed with the Companys Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission
on May 10, 2010 for the Companys three-month period
ended March 31, 2010, and incorporated herein by
reference.
|
29
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
Date: May 9, 2011
|
OPKO Health, Inc.
|
|
|
/s/ Adam Logal
|
|
|
Adam Logal
|
|
|
Executive Director of Finance, Chief
Accounting Officer and Treasurer
|
|
30
Exhibit Index
|
|
|
Exhibit Number
|
|
Description
|
Exhibit 2.4
(+)
|
|
Agreement and Plan of Merger, dated January 28,
2011, among CURNA Inc., KUR, LLC, OPKO
Pharmaceuticals, LLC, OPKO CURNA, LLC, and
certain individuals named therein.
|
|
|
|
Exhibit 10.1
|
|
Amendment No. 2 to the Credit Agreement dated
March 27, 2007, as amended, with the Frost
Group, LLC.
|
|
|
|
Exhibit 10.2
|
|
Third Amended and Restated Subordinated Note and
Security Agreement, dated February 22, 2011,
with the Frost Group, LLC.
|
|
|
|
Exhibit 31.1
|
|
Certification by Phillip Frost, Chief Executive
Officer, pursuant to Rule 13a-14(a) and
15d-14(a) of the Securities and Exchange Act of
1934 as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 for the quarterly
period ended March 31, 2011.
|
|
|
|
Exhibit 31.2
|
|
Certification by Rao Uppaluri, Chief Financial
Officer, pursuant to Rule 13a-14(a) and
15d-14(a) of the Securities and Exchange Act of
1934 as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 for the quarterly
period ended March 31, 2011.
|
|
|
|
Exhibit 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 for the quarterly
period ended March 31, 2011.
|
|
|
|
Exhibit 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 for the quarterly period ended March 31, 2011.
|
31
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE
SUCH OMISSIONS
Exhibit 2.4
AGREEMENT AND PLAN OF MERGER
This Agreement and Plan of Merger (the
Agreement
) is entered into as of January 28,
2011, among CURNA, INC., a corporation organized under the laws of Delaware (the
Company
), the individuals or entities listed on
Schedules 2.3(b)(i) and
2.3(b)(ii)
attached hereto (individually a Seller and collectively the
Sellers
),
KUR, LLC, a Florida limited liability company, and the entity designated as the Sellers
Representative herein, OPKO Pharmaceuticals, LLC, a Delaware limited liability company
(
Buyer
), and OPKO CURNA LLC, a Delaware limited liability company and wholly-owned
subsidiary of Buyer (
Merger Sub
).
RECITALS
A. The Company is engaged in the discovery of new drugs for the treatment of a wide variety of
human illness, metabolic disorders, and genetic anomalies.
B. The parties desire to effect an acquisition of the Company by Buyer through a merger of the
Company with and into Merger Sub on the terms and conditions specified herein.
NOW
,
THEREFORE
, in consideration of the recitals and the respective mutual covenants,
representations, warranties and agreements contained in this Agreement, the parties agree as set
forth below.
ARTICLE 1
Definitions
In addition to terms defined elsewhere in this Agreement, the following terms when used in
this Agreement shall have the meanings indicated below:
Affiliate
of a specified Person means a Person who directly or indirectly through
one or more intermediaries, controls, or is controlled by, or is under common control with the
specified Person. As used in the foregoing sentence, the term control (including, with
correlative meaning, the terms controlling, controlled by and under common control with)
means the possession, directly or indirectly, of the power to direct or cause the direction of the
management and policies of such Person, whether through the ownership of voting securities, by
contract or otherwise, or such other relationship as, in fact, constitutes actual control.
Agreement
means this Agreement together with all exhibits and schedules referred to
herein.
Closing Date
means the date on which the Certificate of Merger is filed with the
Secretary of State of Delaware, or such other closing date as may be mutually agreed to among the
parties in writing.
Closing Date Payment
shall mean the sum of the amounts payable to the Paying Agent
at the Effective Time on the Closing Date pursuant to
Sections 2.3(b)(i)
and
2.3(b)(ii)
.
1
Company Intellectual Property
means the Intellectual Property owned by the Company.
Company IP Agreements
means (a) licenses of Intellectual Property by the Company to
any third party, (b) licenses of Intellectual Property by any third party to the Company, (c)
agreements between the Company and any third party relating to the development or use of
Intellectual Property, and (d) consents, settlements, decrees, orders, injunctions, judgments or
rulings governing the use, validity or enforceability of Company Intellectual Property.
Contracts
means all contracts, agreements, covenants, commitments and other
instruments of any kind, whether oral or written, to which the Company is a party or to which the
assets or properties of the Company are bound.
Deferred Merger Consideration
means the portion of the Merger Consideration
determined in accordance with
Schedule 2.3(b)(iii)
.
Effective Time Payables
means those liabilities and obligations of the Company, not
to exceed $600,000 in the aggregate, to be paid or assumed by the Buyer at the Effective Time as
provided in
Section 2.3(d)
.
Environmental Laws
means any domestic or foreign statute, law, ordinance,
regulation, rule, code or order and any enforceable judicial or administrative interpretation
thereof, including any judicial or administrative order, consent decree or judgment, relating to
pollution or protection of the environment or natural resources, including, without limitation,
those relating to the use, handling, transportation, treatment, storage, disposal, release or
discharge of Hazardous Materials.
Guaranty
means, as to any Person, any contract, agreement or understanding of such
Person pursuant to which such Person guarantees the indebtedness, liabilities or obligations of
others, directly or indirectly, in any manner, including agreements to purchase such indebtedness,
liabilities or obligations, or to supply funds to or in any manner invest in others, or to
otherwise assure the holder of such indebtedness, liabilities or obligations against loss.
Hazardous Materials
means (a) any petroleum, petroleum products, by-products or
breakdown products, radioactive materials, asbestos-containing materials or polychlorinated
byphenyls or (b) any chemical, material or substance defined or regulated as toxic or hazardous or
as a pollutant or contaminant or waste under any applicable Environmental Law.
Intellectual Property
means any or all of the following owned, used or controlled by
the Company: (a) all inventions (whether patentable or unpatentable and whether or not reduced to
practice), all improvements thereto, and all patents, patent applications, and patent disclosures,
together with all reissuances, continuations, continuations-in-part, revisions, extensions, and
reexaminations thereof; (b) all trademarks, service marks, trade dress, logos, trade names, and
corporate names, together with all translations, adaptations, derivations, and combinations thereof
and including all goodwill associated therewith, and all applications, registrations, and renewals
in connection therewith; (c) all copyrightable works, all copyrights, and all applications,
registrations,
and renewals in connection therewith; (d) all trade secrets and confidential business information
(including databases, ideas, research and development, know-how, formulas, compositions,
manufacturing and production processes and techniques, technical data, designs, drawings,
specifications, customer and supplier lists, pricing and cost information, and business and
marketing plans and proposals); (e) all computer programs and software (including data and source
and object codes and related documentation); (f) all other property rights and all licenses and
sublicenses granted by or to the Company that relate to any of the foregoing; and (g) all copies
and tangible embodiments thereof (in whatever form or medium).
2
Knowledge
means, with respect to any representation or warranty or other statement
in this Agreement qualified by the knowledge of the Company, the actual knowledge of each director
or officer of the Company, and with respect to any representation or warranty or other statement in
this Agreement qualified by the knowledge of any other party, the actual knowledge of the officer
of the party responsible for such information, in each case, following a reasonable investigation
as to the matters that are subject to such representation, warranty or other statement.
Law
means any law, statute, ordinance, rule, regulation, order, writ, judgment or
decree.
Liabilities
means any liability (whether known or unknown, whether asserted or
unasserted, whether absolute or contingent, whether accrued or unaccrued, whether liquidated or
unliquidated and whether due or to become due), any and all actions, suits, proceedings, demands,
liabilities, damages, claims, deficiencies, fines, penalties, interest, assessments, judgments,
losses, Taxes, costs and expenses, including, without limitation, reasonable fees and disbursements
of counsel and experts.
Licensed Intellectual Property
means Intellectual Property licensed to the Company
pursuant to the Company IP Agreements.
Liens
means any liens, claims, charges, rights, pledges, security interests,
mortgages, options, title defects or other encumbrances, restrictions or limitations of any nature
whatsoever.
Material Adverse Effect
means any change in or effect on the business of the Company
that is, or could reasonably be expected to be, materially adverse to the business, assets
(including intangible assets), liabilities (contingent or otherwise), condition (financial or
otherwise), prospects or results of operations of the Company taken as a whole.
Merger Consideration
has the meaning set forth in
Section 2.3(a).
Noteholder
means Joseph Collard.
Notes
means those convertible promissory notes of the Company in favor of the
Noteholder, dated June 1, 2009, March 1, 2010, September 20, 2010 and January 28, 2011, in the
respective principal amounts of $1,000,000, $250,000, $350,000, and $310,000 (not yet documented by
Note).
Optionholders
means the individuals or entities who or which collectively own all of
the issued and outstanding options, warrants or other rights to purchase or acquire any capital
stock of the Company. The Optionholders are listed on
Schedule 2.3(b)(ii)
attached hereto.
3
Organizational Documents
means any and all documents pursuant to which an entity is
organized and/or operates under the applicable laws of its jurisdiction.
Paying Agent
means Angell Corporate Services, Inc. (
Paying Agent
), as
Paying Agent under that certain Paying Agent Agreement (the
Paying Agent Agreement
) of
even date among the Buyer, the Company and the Paying Agent.
Percentage Interest
means the percentage interest of each Seller based on the number
of shares of the Companys Common Stock held by such Shareholder or number of vested options to
which such Optionholder is entitled, divided by the total number of outstanding shares of Common
Stock and vested options, as shown on
Schedules 2.3(b)(i)
and
2.3(b)(ii)
.
Person
means any natural person, corporation, limited liability corporation,
unincorporated organization, partnership, association, joint stock company, joint venture, trust or
government, or any agency or political subdivision of any government, or any other entity.
Securities
means all of the issued and outstanding equity interests in the Company
as of the Effective Time.
Sellers
means, collectively, the Shareholders and the Optionholders.
Sellers Representative
means KUR, LLC, a Florida limited liability company
designated by the Sellers to act as the representative of the Sellers pursuant to this Agreement.
Shareholders
means the individuals or entities who or which collectively own all of
the issued and outstanding capital stock of the Company. The Shareholders are listed on
Schedule 2.3(b)(i)
attached hereto.
Subsidiary
of a specified Person means a Person in which such Person owns, directly
or indirectly, an equity interest of 50% or more, or any Person which may be controlled by, or
under common control with the specified Person, whether through the ownership of Voting Securities,
by contract or otherwise.
Tax
means any national, state, local or foreign income, gross receipts, franchise,
estimated, alternative minimum, add-on minimum, sales, use, transfer, registration, all gross
receipts, sales, use,
ad valorem
, value added, excise, natural resources, severance, stamp,
occupation, premium, windfall profit, assets, minimum income, environmental, customs, duties, real
property, personal property, capital stock, social security obligations or contributions,
unemployment, disability, payroll, license, employee or other withholding, or other tax or
governmental charge, of any kind whatsoever, including any interest, penalties or additions to tax
or additional amounts in respect of the foregoing.
Transaction Documents
means this Agreement, the Paying Agent Agreement and all other
documents to be executed and delivered by either party pursuant to or in connection with this
Agreement and consummation of the transactions contemplated hereby.
4
ARTICLE 2
The Merger; Consideration
2.1
The Merger
.
Upon the terms and subject to the conditions set forth in this
Agreement and in accordance with the Delaware General Corporation Law (
DGCL
), the Company
will be merged with and into Merger Sub in accordance with the DCGL (the
Merger
) through
the filing of a Certificate of Merger with the Secretary of State of the State of Delaware. The
Merger shall become effective at such time as the Certificate of Merger have been duly filed or at
such other time as specified in the Certificate of Merger (the
Effective Time
)
2.2
Effect of the Merger
.
At the Effective Time, the separate existence of the
Company shall cease, and Merger Sub shall (i) continue as the surviving entity of the Merger, (ii)
be governed and continue its existence as a limited liability company formed under the laws of
Delaware, and (iii) succeed to and assume all rights and obligations of the Company and Merger Sub
in accordance with the DGCL. Merger Sub as the surviving entity after the Merger is hereinafter
sometimes referred to as the
Surviving Entity
.
2.3
Conversion of Securities of Company; Merger Consideration
.
(a) In connection with the Merger, Buyer has agreed to pay an aggregate of (i) Ten Million
Dollars plus (ii) the Deferred Merger Consideration payable pursuant to
Section
2.3(b)(iii)
, less (iii) the amount payable pursuant to
Section 2.3(b)
(the
Merger
Consideration
).
(b) At the Effective Time, by virtue of the Merger and without any action on the part of
Buyer, Merger Sub, the Company or their respective shareholders, all of the Securities of the
Company issued and outstanding immediately prior to the Effective Time shall be canceled and
converted automatically into the right to receive the Merger Consideration, payable as follows:
(i) An aggregate of $7,422,241.63, constituting a portion of the Closing Date Payment, shall
be paid at the Effective Time to the Paying Agent for the benefit of the Shareholders pursuant to
the Paying Agent Agreement, allocated among the Shareholders as set forth on
Schedule
2.3(b)(i)
;
(ii) An aggregate of $243,571.00, constituting the balance of the Closing Date Payment, shall
be paid at the Effective Time to the Paying Agent for the benefit of the Optionholders pursuant to
the Paying Agent Agreement, allocated among the Optionholders as set forth on
Schedule
2.3(b)(ii)
; and
(iii) A contingent amount, designated herein as the Deferred Merger Consideration, shall be
payable to the Sellers Representative at the times and in the amounts. determined in accordance
with
Schedule 2.3(b)(iii)
.
(c) At the Effective Time, Buyer shall, on behalf of the Company, pay to the Paying Agent for
the benefit of the Noteholder pursuant to the Paying Agent Agreement, the sum of $2,121,938.67
(which represents the aggregate principal and interest outstanding on the Notes as of Closing),
following which the Notes shall be deemed cancelled and paid in full and all obligations of the
Company under the Notes shall be fully and finally satisfied and discharged.
5
(d) At the Effective Time, Buyer shall, on behalf of the Company, pay to the Paying Agent for
the benefit of certain obligees of the Effective Time Payables the sum of $543,735.71, (which
represents the amount of the Effective Time Payables listed on
Schedule 2.3(d)
to be paid
at the Effective Time out of funds provided by the Buyer), to be applied by the Paying Agent to the
satisfaction of the Effective Time Payables due at the Effective Time (
Closing Payables
),
and pursuant to the Merger, the Buyer and Merger Sub shall assume and pay when and as due, the
remaining Effective Time Payables of $54,285.98 listed on
Schedule 2.3(d)
to be paid after
the Effective Time in the ordinary course (
Assumed Liabilities
). Except for the Closing
Payables and Assumed Liabilities, and for liabilities incurred by the Company after Closing in the
ordinary course pursuant to agreements disclosed in the Disclosure Schedules, neither Buyer, Merger
Sub or the Company shall be responsible for any Liabilities of the Company, and such Liabilities
shall reduce dollar for dollar the amount of the Merger Consideration otherwise payable to the
Sellers. The Paying Agent shall be authorized pursuant to the Paying Agent Agreement to utilize
$212,248.69 of the Closing Date Payment of the Merger Consideration payable pursuant to
Section
2.3(b)(i)
and
2.3(b)(ii)
to pay the remaining balances of the Effective Time Payables
due at the Effective Time, as shown on
Schedule 2.3(d)
, and for the other uses and
Liabilities identified on
Schedule 2.3(d)
, totaling $755,984.40 (the
Seller
Liabilities
).
2.4
Certificate of Formation; Bylaws
. At and as of the Effective Time, the
Certificate of Formation of the Merger Sub as in effect immediately prior to the Effective Time
shall be the Certificate of Formation of the Surviving Entity. At and as of the Effective Time, the
limited liability company agreement of the Merger Sub as in effect immediately prior to the
Effective Time shall be the limited liability company agreement of the Surviving Entity until
amended or repealed in accordance with the provisions thereof and applicable law.
2.5
Directors and Officers
. At and as of the Effective Time, the managers and
officers of the Merger Sub immediately prior to the Effective Time shall be the managers and
officers of the Surviving Entity and shall serve in such capacities until their respective
successors are duly elected and qualified.
ARTICLE 3
Representations and Warranties of Buyer and Merger Sub
In order to induce the Company and the Shareholders to enter into this Agreement and to
consummate the transactions contemplated hereby, Buyer and Merger Sub make the representations and
warranties set forth below to the Company and the Shareholders.
3.1
Organization
.
Each of Buyer and Merger Sub is a limited liability company duly
organized, validly existing and in good standing under the laws of Delaware. Buyer and Merger Sub
are duly qualified or licensed to do business, and are in good standing, in each jurisdiction where
the
character of the properties owned, leased or operated by their or the nature of their
businesses makes such qualification or licensing necessary. Buyer and Merger Sub have all requisite
right, power and authority to (a) own or lease and operate their properties, (b) conduct their
businesses as presently conducted and (c) engage in and consummate the transactions contemplated
hereby.
6
3.2
Authorization; Enforceability
.
Each of Buyer and Merger Sub has all requisite
right, power and authority to execute and deliver the Transaction Documents and to consummate the
transactions contemplated thereby. The execution and delivery of the Transaction Documents by Buyer
and Merger Sub and the consummation by Buyer and Merger Sub of the transactions contemplated
thereby have been duly authorized by all requisite corporate or other action. The Transaction
Documents have been duly executed and delivered by Buyer and Merger Sub, and constitute the legal,
valid and binding obligation of Buyer and Merger Sub, enforceable in accordance with their
respective terms.
3.3
No Violation or Conflict
.
The execution and delivery of the Transaction Documents
by Buyer and Merger Sub, the consummation by Buyer and Merger Sub of the transactions contemplated
thereby, and compliance by the Buyer and Merger Sub with the provisions hereof: (a) do not and will
not violate or, if applicable, conflict with any provision of Law, or any provision of Buyers or
Merger Subs Organizational Documents; and (b) do not and will not, with or without the passage of
time or the giving of notice, result in the breach of, or constitute a default, cause the
acceleration of performance or require any consent under, any instrument or agreement to which
Buyer or Merger Sub is a party or by which Buyer or Merger Sub or their properties may be bound or
affected.
3.4
Brokers
.
Neither Buyer nor Merger Sub has employed any financial advisor, broker
or finder and has not incurred and will not incur any brokers, finders, investment banking or
similar fees, commissions or expenses, in connection with the transactions contemplated by this
Agreement, which would be payable by the Company.
ARTICLE 4
Representations and Warranties of the Company
In order to induce Buyer and Merger Sub to enter into this Agreement and to consummate the
transactions contemplated hereby, the Company makes the representations and warranties set forth
below to Buyer and Merger Sub.
4.1
Organization
. The Company has been duly organized and is validly existing and in
good standing under the laws of the jurisdiction of its incorporation or organization, as the case
may be. The Company is duly qualified or licensed to do business, and is in good standing, in each
jurisdiction where the character of the properties owned, leased or operated by it or the nature of
its business makes such qualification or licensing necessary. The Company has all requisite right,
power and authority to (a) own or lease and operate its properties, (b) conduct its business as
presently conducted and (c) engage in and consummate the transactions contemplated hereby. The
Company is not in default under its Organizational Documents.
4.2
Authorization; Enforceability
.
The Company has all requisite right, power and
authority to execute and deliver the Transaction Documents and consummate the transactions
contemplated thereby. The execution and delivery of the Transaction Documents by the Company and
the consummation by it of the transactions contemplated hereby have been duly authorized by all
requisite corporate action. The Transaction Documents have been duly executed and delivered and
constitute the legal, valid and binding obligations of the Company, enforceable in accordance with
their respective terms.
7
4.3
No Violation or Conflict
.
Except as set forth on Schedule 4.3, the execution and
delivery of the Transaction Documents by the Company and the consummation by the Company of
Schedule 4.3
, the execution and delivery of the Transaction Documents by the Company and
the consummation by the Company of the transactions contemplated hereby, and compliance by the
Company with the provisions hereof: (a) do not and will not violate or conflict with any provision
of Law or any provision of the Companys Organizational Documents; and (b) do not and will not,
with or without the passage of time or the giving of notice, result in the breach of, or constitute
a default, cause the acceleration of performance or require any consent under, or result in the
creation of any Lien upon any property or assets of the Company pursuant to any instrument or
agreement to which the Company is a party or by which the Company or its properties may be bound or
affected.
4.4
Organizational Documents and Corporate Records
.
A true and complete copy of (a)
the Organizational Documents of the Company, as amended, and (b) a copy of the minute book of the
Company has been delivered to Buyer. Such minute book contains complete and accurate records of all
meetings and other corporate actions of the board of directors, committees of the board of
directors, and shareholders of the Company from the date of its incorporation to the date hereof.
All matters requiring the authorization or approval of the board of directors, a committee of the
board of directors, or the shareholders of the Company have been duly and validly authorized and
approved by them.
4.5
Subsidiaries
.
The Company has no Subsidiaries or equity interests in any other
Person.
4.6
Capitalization
.
The authorized share capital of the Company is as set forth on
Schedule 4.6
.
Schedule 4.6
sets forth all Securities which are issued and
outstanding and, except as set forth on
Schedule 4.6
, all of such Securities have been duly
authorized, are validly issued, fully paid and nonassessable and were issued in compliance with
applicable state and federal securities laws. To the Knowledge of the Company and except as set
forth on
Schedule 4.6
, all outstanding Securities are owned by the Shareholders free and
clear of all Liens, preemptive rights, rights of first refusal, registration rights, limitations on
the Shareholders voting rights, voting agreements, shareholder agreements, charges or other
encumbrances, transfer restrictions, or agreements of any nature whatsoever. The Company has no
(and has not since inception had any) investment or equity interest in any other Person. None of
the Securities were issued in violation of any preemptive rights or rights of first refusal, or
other agreements or rights. Except as set forth on
Schedule 4.6
, no written or oral
agreement or understanding with respect to the disposition of the Securities or any rights therein,
other than this Agreement, exists. The Company does not have and will not have any liability or
obligation of any nature whatsoever to any former shareholder, and the consummation of
the transactions contemplated by this Agreement will not trigger any preemptive rights, rights
of first refusal, or similar obligations, or any obligation to provide notice to any shareholder.
8
4.7
Rights, Warrants, Options
.
The Company has reserved 125 shares of Company common
stock for issuance to officers, directors, employees, and consultants of the Company pursuant to
its 2008 Equity Incentive Plan, which has been duly adopted by the Companys board of directors and
shareholders. The Company has furnished to Buyer complete and accurate copies of the 2008 Equity
Incentive Plan and agreements for use thereunder. Except as set forth on
Schedule
2.3(b)(ii)
there are no stock options, warrants, stock appreciation, phantom stock or other
rights, arrangements or commitments of any character to which the Company is a party or by which
the Company is bound relating to the issued or unissued capital stock or equity interests of the
Company or obligating the Company to issue or sell any shares of capital stock of, or other equity
interests in, the Company. There are no outstanding obligations of the Company to redeem or
otherwise acquire any of the Securities. There are no outstanding contractual obligations of the
Company to provide funds to, or make any investment (in the form of a loan, capital contribution or
otherwise) in, any other Person.
4.8
Financial Statements
.
The Company has delivered to Buyer a true and complete copy
of (A) the consolidated balance sheet of the Company for the fiscal years ended on June 30, 2010,
2009, and 2008, and the audited consolidated profit and loss statement for the fiscal years ended
on June 30, 2010, 2009, and 2008, including any related notes and the consolidated supplements, and
(B) the unaudited balance sheet of the Company through the month ended December 31, 2010, and the
unaudited consolidated profit and loss statement of the Company for the period ending on that date
(collectively, the
Financial Statements
). The Financial Statements: (a) have been
prepared in accordance with the books of account and records of the Company; (b) fairly present,
and are true, correct and complete statements of the consolidated financial condition of the
Company and the results of its operations at the dates and for the periods specified in those
statements; and (c) have been prepared in accordance with United States generally accepted
accounting principles, consistently applied with prior periods, except that such unaudited
Financial Statements do not include all information and footnotes required by United States
generally accepted accounting principles. At Closing, the Company will also deliver to Buyer an
unaudited preliminary balance sheet as of the Closing Date (the Closing Trial Balance). The
Closing Trial Balance will (x) be prepared in accordance with the books of account and records of
the Company and (y) fairly present a true, correct and complete statement in all material respects
of the consolidated financial condition of the Company at the Closing Date.
4.9
Absence of Undisclosed Liabilities
.
Except as set forth on
Schedule 4.9
,
and except for obligations arising post-closing in the ordinary course pursuant to agreements
disclosed in the Disclosure Schedules, the Company does not have and will not have on the Closing
Date any debts, Liabilities, commitments or obligations of any nature whatsoever, whether accrued,
absolute, contingent or otherwise, other than as provided for in this Agreement. To the Knowledge
of the Company, there is no basis for assertion against the Company of any such debt, Liability,
commitment or obligation not so disclosed. For the avoidance of doubt, Buyer is not assuming any
debt, Liabilities, commitments or obligations not specifically included as Closing Payables or
Assumed Liabilities in
Section 2.3(d)
or obligations arising post-closing in the ordinary
course
pursuant to agreements otherwise disclosed in the Disclosure Schedules, and Buyer will be
indemnified for such pursuant to
Section 6.4
.
4.10
Guaranties
.
Except as set forth in
Schedule 4.10
, the Company is not a
party to any Guaranty, and no Person is a party to any Guaranty for the benefit of the Company.
9
4.11
Accounts and Notes Receivable and Payable
.
Set forth on
Schedule 4.11
is
a true and complete aged list of unpaid accounts and notes receivable owing to and owed by the
Company as of Closing, including the Effective Time Payables. Except as set forth on
Schedule
4.11
, all of such accounts and notes receivable and payable constitute only bona fide, valid
and binding claims arising in the ordinary course of the business, subject, with regard to
receivables to no valid defenses, counterclaims or setoffs.
4.12
Absence of Material Adverse Effects
.
Since June 30, 2010, and except as
otherwise disclosed on
Schedule 4.12
, the Company has conducted its businesses only in the
ordinary and usual course and in a manner consistent with past practices and, since such date: (a)
there has been no Material Adverse Effect; and (b) the Company has not engaged or agreed to engage
in any of the actions described below:
(a) amend or otherwise change its Organizational Documents;
(b) issue, sell or authorize for issuance or sale, shares of any class of its securities
(including, but not limited to, by way of stock split or dividend) or any subscriptions, options,
warrants, rights or convertible securities, or enter into any agreements or commitments of any
character obligating them to issue or sell any such securities;
(c) redeem, purchase or otherwise acquire, directly or indirectly, any shares of its capital
stock or any option, warrant or other right to purchase or acquire any such shares;
(d) declare or pay any dividend or other distribution (whether in cash, stock or other
property) with respect to its capital stock or repay any irrevocable capital contribution;
(e) sell, transfer, surrender, abandon or dispose of any of its assets or property rights
(tangible or intangible), except in the ordinary course of business consistent with past practices;
(f) grant or make any Lien or subject itself or its properties or assets to any Lien, except
in the ordinary course of business consistent with past practices;
(g) grant any license or sublicense of any right under or with respect to any Intellectual
Property;
(h) create, incur or assume any indebtedness or any Liability, except in the ordinary course
of business consistent with past practices;
(i) make or commit to make any capital expenditures;
(j) grant or become subject to any Guaranty;
(k) apply any of their respective assets to the direct or indirect payment, discharge,
satisfaction or reduction of any amount payable directly or indirectly by, to or for the benefit of
the Company or any Affiliate thereof or to the prepayment of any such amounts or engage in any
transactions with any Affiliate;
10
(l) write off the value of any assets, inventory or any accounts receivable or increase, the
reserves for obsolete, damaged, spoiled or otherwise not usable inventory or doubtful or
uncollectable receivables;
(m) increase the compensation payable or to become payable to directors, officers or
employees, other than increases in the ordinary course of business and consistent with past
practice or grant any rights to severance or termination pay to, or enter into any employment or
severance agreement with, any director, officer or other employee of the Company or any Affiliate
thereof, or establish, adopt, enter into or materially amend any collective bargaining, bonus,
profit sharing, thrift, compensation, stock option, restricted stock, pension, retirement, deferred
compensation, employment, termination, severance or other plan, agreement, trust, fund, policy or
arrangement for the benefit of any director, officer or employee;
(n) enter into any transaction, commitment or agreement, or amend or terminate any existing
Contract material to the Company;
(o) acquire (including, without limitation, by merger, consolidation or acquisition of stock
or assets) any interest in any corporation, partnership, other business organization, Person or any
division thereof or any assets;
(p) alter the manner of keeping its books, accounts or records, or change in any manner the
accounting practices, methods or assumptions therein reflected;
(q) agree to accelerate or delay collection of notes or accounts receivable in advance of or
beyond their regular dates or the date when the same could have been collected in the ordinary
course of business consistent with past practices;
(r) waive, release, assign, settle or compromise any claims or litigation;
(s) make any Tax election or settle or compromise any federal, state or local or federal
income Tax liability;
(t) take or omit to take any action which is intended to render any of the Companys
representations or warranties untrue or misleading, or which would be a material breach of any of
the covenants of this Agreement;
(u) take any action which could have a Material Adverse Effect; or
(v) agree, whether in writing or otherwise, to do any of the foregoing
4.13
List of Accounts
.
Set forth on
Schedule 4.13
is: (a) the name and
address of each bank or other institution in which the Company maintains an account (cash,
securities or other) or
safe deposit box; (b) the name and phone number of the Companys contact person at such bank
or institution; (c) the account number of the relevant account and a description of the type of
account; and (d) the persons authorized to transact business in such accounts.
11
4.14
Tax Matters
. All Tax returns and other similar documents required to be filed
with respect to the Company have been timely filed (after taking into account any extensions to
file) with the appropriate governmental authorities in all jurisdictions in which such returns and
documents are required to be filed prior to the Closing Date, all of the foregoing as filed are
true, correct and complete and reflect accurately all liabilities for Taxes of the Company for the
periods to which such returns and documents relate, and all amounts shown as owing thereon have
been paid. No claims or deficiencies have been asserted against the Company with respect to any
Taxes which have not been paid or otherwise satisfied or for which accruals or reserves have not
been made in the Financial Statements, and to the Knowledge of the Company, there exists no
reasonable basis for the making of any such claim. The Company has not waived any restrictions on
assessment or collection of Taxes or consented to the extension of any statute of limitations
relating to taxation.
4.15
Insurance
.
Set forth on
Schedule 4.15
is a list of all insurance
policies providing insurance coverage of any nature to the Company. The Company has delivered to
Buyer a true and complete copy of all of such insurance policies, as amended. Such policies are
sufficient for the compliance by the Company with all requirements of Law and all Company
Contracts. All of such policies are in full force and effect and are valid and enforceable in
accordance with their terms, and the Company has complied with all terms and conditions of such
policies, including the payment of premium payments. To the Knowledge of the Company, none of the
insurance carriers has indicated an intention to cancel or not renew any such policy. The Company
does not have any claim pending or, to the Knowledge of the Company, anticipated against any of the
insurance carriers under any of such policies, and there has been no actual or alleged occurrence
of any kind which may give rise to any such claim.
4.16
Assets
. The Company owns, leases or has the legal rights to use all properties
and assets (tangible and intangible) used or intended to be used in the conduct of the Companys
business and each item of equipment or other personal property included as an asset in the
Financial Statements (the
Assets
). The Company has good and marketable title or leasehold
interest to each Asset, free and clear of all Liens. The Assets constitute all of the assets and
rights required to operate the business of the Company as previously conducted and as contemplated
to be conducted. All of the Assets are in good operating condition and repair, ordinary wear and
tear excepted.
Schedule 4.16
sets forth a full and complete list of the material Assets
owned by the Company.
4.17
Intellectual Property
.
(a)
Schedule 4.17(a)
sets forth a true and complete list of (i) all patents and patent
applications, registered trademarks and trademark applications, registered copyrights and copyright
applications and domain names included in the Company Intellectual Property, (ii) all Company IP
Agreements, and (iii) other Company Intellectual Property material to the Companys business.
(b) The Company is the exclusive owner of the entire right, title and interest in and to the
Company Intellectual Property, and has a valid license to use the Licensed Intellectual Property
in connection with the Companys business. The Company is entitled to use all Company
Intellectual Property and Licensed Intellectual Property in the continued operation of the
Companys business without limitation, subject only to the terms of the Company IP Agreements. The
Company Intellectual Property and the Licensed Intellectual Property have not been adjudged invalid
or unenforceable in whole or in part, and are valid and enforceable.
12
(c) The conduct of the Companys business as currently conducted does not infringe or
misappropriate the Intellectual Property of any third party, and no Action alleging any of the
foregoing are pending, and no Action has been threatened or asserted against any Shareholder or the
Company alleging any of the foregoing. To the Knowledge of the Company, no Person is engaging in
any activity that infringes the Company Intellectual Property.
(d) No Company Intellectual Property is subject to any outstanding Governmental Order
restricting the use of such Intellectual Property or that would impair the validity or
enforceability of such Intellectual Property.
4.18
Real Property
.
(a) The Company does not own any real property.
(b)
Schedule 4.18(b)
sets forth the street address of each parcel of real property
leased by the Company (the
Leased Real Property
). The Company has previously delivered to
Buyer true and complete copies of all lease agreements, as amended to date (the
Leases
)
relating to the Leased Real Property. The Company enjoys peaceable and undisturbed possession of
the Leased Real Property.
4.19
Compliance with Environmental Laws
. The Company is in compliance with all
applicable Environmental Laws. To the Knowledge of Company, there are no pending governmental
claims, citations, notices of violation, judgments, decrees or orders issued against the Company
for impairment or damage, injury or adverse effect to the environment or public health and, to the
Knowledge of the Company and there have been no private complaints with respect to any such
matters. To the Knowledge of the Company, there is no condition relating to any properties of the
Company that would require any type of remediation, clean-up, response or other action under
applicable Environmental Laws. The Company has complied with all applicable Environmental Laws in
the generation, treatment, transportation, storage and disposal of Hazardous Materials.
4.20
Employment Matters
.
(a)
Employment Agreements
.
Schedule 4.20(a)
sets forth all employment,
consulting, severance, and indemnification arrangements, agreements and understandings between the
Company and any officer, director, advisory board member, consultant or employee (
Employment
Agreements
). The Company has delivered to the Buyer true and complete copies of all of the
Employment Agreements. No Employment Agreement (i) will require any payment by the Company or Buyer
to any director, officer or employee of the Company, or any other party, by reason of the change in
control of the Company resulting from the transactions contemplated by this Agreement, or (ii)
provides for the acceleration or change in the award, grant, vesting or
determination of options, warrants, rights, severance payments, or other contingent
obligations of any nature whatsoever of the Company in favor of any such parties. Except as set
forth on
Schedule 4.20(a)
, the terms of employment or engagement of all directors,
officers, employees, agents, consultants and professional advisers of the Company are such that
their employment or engagement may be terminated at any time without liability for payment of
compensation or damages (other than, with respect to employees of the Company, the payment of the
statutory minimum compensation) and the Company has not entered into any agreement or arrangement
for the management of its business or any part thereof other than with its directors or employees.
13
(b)
Personnel
.
Schedule 4.20(b)
contains the names, job descriptions and
annual salary rates and other compensation of any kind of all officers, directors, advisory board
members, consultants, and employees of the Company.
(c)
Employment Laws
. Except as set forth on
Schedule 4.20(c)
, the Company and
each of the Company Subsidiaries has complied with all applicable employment Laws, including
payroll, withholding and related obligations, benefits, social security, and does not have any
obligation in respect of any amount due to employees of the Company or the Company Subsidiaries or
government agencies, other than normal salary, other fringe benefits and contributions accrued but
not payable on the date hereof.
(d)
Policies
.
Schedule 4.20(d)
contains a list of all employee policies
(written or otherwise), employee manuals or other written statements of rules or policies
concerning employment, including working conditions, vacation and sick leave, a complete copy of
each of which (or, if oral, an accurate written summary thereof) has been previously delivered to
Purchasers.
(e)
Employee Benefit Plans
. The Company offers no benefit to its employees other than
those required by law.
4.21
Labor Relations
. There is no strike or dispute pending or, to the Knowledge of
the Company, threatened involving any employees of the Company. None of the employees of the
Company is a member of any labor union, and the Company is not a party to, otherwise bound by or,
to the Knowledge of the Company, threatened with any labor or collective bargaining agreement. None
of the employees of the Company are engaged in organizing any labor union or other employee group
that is seeking recognition as a bargaining unit. There are no unfair labor practice complaints
pending or, to the Knowledge of the Company, threatened against the Company, and no Person has made
any claim, and there is no basis for any claim, against the Company under any statute, regulation
or ordinance relating to employees or employment practices, including without limitation those
relating to age, sex and racial discrimination, conditions of employment, and wages and hours.
4.22
Contracts
.
Schedule 4.22
sets forth a list of all Contracts, (oral or
written) to which the Company is a party, or by which any of its assets are bound or affected,
which is material to the Companys business, including without limitation.
Schedule 4.22
further identifies each of the Contracts which contain anti-assignment, change of control or notice
of assignment or change of control provisions. The Contracts are each in full force and effect and
are the valid and legally
binding obligations of the Company and, to the Companys Knowledge, are valid and binding
obligations of the other parties thereto. The Company has not received notice of default by the
Company under any of the Company Contracts, and the Company is not in default under any Company
Contract to which it is a party, and no event has occurred which with the giving of notice or lapse
of time or both would constitute such a default. The Company has previously delivered or will
deliver prior to the Closing Date to Buyer true, complete and correct copies of all such Contracts.
None of the Contracts was entered into outside the ordinary course of business of the Company and
none contain any provisions that could reasonably be expected to impair or adversely affect in any
material way the operations of the Company.
14
4.23
Related Parties
. Except as set forth in
Schedule 4.23
, no officer,
director, employee, consultant, or shareholder of the Company, nor any relative or spouse of such
officer, director, employee, consultant or shareholder, has, directly or indirectly, (a) any
ownership interest in any property or asset, tangible or intangible, including any Company
Intellectual Property, used in the conduct of the Companys business; (b) any interest in or is,
directly or indirectly, a party to, any Contract, except as provided in
Schedule 4.23
; (c)
any cause of action or claim whatsoever against, or owes any amount to, the Company except as
provided in
Schedule 4.23
, or (d) any Liability to the Company. Except as set forth in
Schedule 4.23
, the Company has no Liability to any shareholder or its or their
Representatives or Affiliates.
4.24
Absence of Certain Business Practices
.
Neither of the Company nor, to the
Knowledge of the Company, any of the Shareholders or current directors or officers of the Company
(individually, an
Additional Party
and collectively, the
Additional Parties
),
nor agents of the Company, nor any other Person acting on behalf of or associated with the Company,
acting alone or together, has: (a) received, directly or indirectly, any rebates, payments,
commissions, promotional allowances or any other economic benefits, regardless of their nature or
type, from any customer, supplier, employee or agent of any customer or supplier, official or
employee of any government (domestic or foreign) or other Person; or (b) directly or indirectly,
given or agreed to give any money, gift or similar benefit to any customer, supplier, employee or
agent of any customer or supplier, official or employee of any government (domestic or foreign), or
any political party or candidate for office (domestic or foreign) or other Person who was, is or
may be in a position to help or hinder the business of the Company (or assist the Company in
connection with any actual or proposed transaction).
4.25
Compliance with Laws
. The Company is in compliance with all Laws and other legal
requirements applicable to it or its properties, including without limitation those relating to (a)
the development, testing, manufacture, packaging, labeling, distribution, consumer protection and
marketing of products or the provision of services, (b) employment, safety and health and (c)
building, zoning and land use. The Company has not received notification from any governmental or
regulatory authority asserting that it is not in compliance with or has violated any of the Laws,
which such governmental or regulatory authority enforces, or threatening to revoke any
authorization, consent, approval, franchise, license, or permit, and the Company is not subject to
any agreement or consent decree with any governmental or regulatory authority arising out of
previously asserted violations.
4.26
Governmental Authorizations
. The Company has all authorizations, consents,
approvals, franchises, licenses and permits required under applicable Law for the ownership of the
Companys properties and operation of its business as presently operated and as it is reasonably
expected to be operated in the future, except that approval from the U.S. Food and Drug
Administration to sell products of the Company has not been obtained (the
Permits
). No
suspension nonrenewal or cancellation of any of the Permits is pending or, to the Knowledge of the
Company, threatened, and there is no reasonable basis therefor. The Company is not in conflict
with, or in default or violation of any Permits.
15
4.27
Legal Proceedings
.
The Company is not a party to any pending or, to the
Knowledge of the Company, threatened, legal, administrative or other proceeding, arbitration,
mediation, out-of-court settlement negotiation or investigation. To the Knowledge of the Company,
no Person who is or was a director or officer of the Company is a party to any pending or
threatened, legal, administrative or other proceeding, arbitration, mediation, out-of-court
settlement negotiation or investigation in their capacity as directors or officers of the Company.
The Company is not subject to any order, writ, injunction, decree or other judgment of any court or
governmental or regulatory authority.
4.28
Consent of Governmental Authorities
.
No consent, approval or authorization of,
or registration, qualification or filing with any governmental or regulatory authority, or any
other Person, is required to be made by the Company in connection with the execution, delivery or
performance of this Agreement the Company or the consummation by the Company of the transactions
contemplated hereby.
4.29
Products and Services
.
(a)
Schedule 4.29
lists (i) each product which is developed or currently under
development by the Company, or licensed, distributed or sold by the Company (collectively, the
Products) and (ii) each service provided by the Company (collectively, the
Services
).
Each Product has been distributed or sold in accordance with, and each Service has been provided in
compliance with, the applicable contractual commitments, express or implied warranties, product and
service specifications and quality standards for such Product and Service, and the provisions of
all applicable Laws. No Product or Service sold, provided or delivered by the Company is subject to
any guaranty, warranty (other than warranties imposed by Law) or other indemnity.
(b) At no time have any of the Products been recalled, withdrawn or suspended by the Company,
voluntarily or otherwise; nor are there any pending Actions or proceedings seeking the recall,
withdrawal, suspension or seizure of any Product; and neither the Company has received any
regulatory letters, warning letters, or other notice of adverse findings.
(c) There exist no set of facts: (i) which could furnish a basis for the withdrawal or
suspension of any Permit, license, approval or consent of any Governmental Authority with respect
to the Company, or any Product or Service; (ii) which could furnish a basis for the recall,
withdrawal or suspension of any Product from the market, the termination or suspension of any
clinical testing of any Product, or the change in marketing classification of any Product or (iii)
which could furnish a basis for the termination or suspension of any Service.
4.30
Brokers
.
The Company has not employed any financial advisor, broker or finder
and have not incurred and will not incur any brokers, finders, investment banking or similar
fees, commissions or expenses in connection with the transactions contemplated by this Agreement,
which would be payable by the Company or Buyer.
16
4.31
Disclosure
. No representation or warranty of the Company contained in this
Agreement, and no statement, notice, certificate or other document furnished by or on behalf of the
Company to Buyer or its agents pursuant hereto or in connection with the transactions contemplated
hereby, contains or will contain any untrue statement of a material fact or omits to state a
material fact necessary in order to make the statements contained herein or therein not misleading.
ARTICLE 5
Representations and Warranties of Sellers
In order to induce Buyer and Merger Sub to enter into this Agreement and to consummate the
transactions contemplated hereby, each of the Sellers, severally and not jointly, makes the
representations and warranties set forth below to Buyer and Merger Sub with respect to himself,
herself or itself.
5.1
Title to Securities
.
Such Seller is the record and beneficial owner of the
Securities listed opposite his or its respective name on
Schedules 2.3(b)(i)
and
2.3(b)(ii)
, as applicable, and such Securities are owned free and clear of any Liens
whatsoever, including, without limitation, transfer restrictions, preemptive rights, registration
rights, rights of first refusal, or any claims or rights under any voting trust agreements,
shareholder agreements or other agreements. At the Closing, such Seller will accept the Merger
Consideration provided for such Seller herein in exchange for all of such Sellers right, title and
interest in the Securities owned by him, her or it, which shall be free and clear of all Liens
whatsoever.
5.2
Authorization; Enforceability
. Except as set forth on
Schedule 5.2
, no
written or oral agreement or understanding with respect to the disposition of the Securities or any
rights therein, other than this Agreement, exists. Such Seller has all requisite right, power and
authority to execute and deliver the Transaction Documents and to consummate the transactions
contemplated thereby. The Transaction Documents have been duly executed and delivered by such
Seller and constitute the legal, valid and binding obligations of such Seller, enforceable in
accordance with their respective terms.
5.3
No Consent, Violation or Conflict
. The execution and delivery of the Transaction
Documents by such Seller and the consummation by such Seller of the transactions contemplated
hereby, and compliance by the Seller with the provisions hereof, (a) do not require any prior
governmental or regulatory consent, approval, or notice of any kind (b) do not and will not violate
or, if applicable, conflict with any provision of Law, or any provision of such Sellers
Organizational Documents, and (c) do not and will not, with or without the passage of time or the
giving of notice, result in the breach of, or constitute a default, cause the acceleration of
performance or require any consent under, or result in the creation of any Lien upon any property
or assets of such Seller pursuant to any instrument or agreement to which such Seller is a party or
by
which such Seller or such Sellers properties may be bound or affected, except as set forth on
Schedule 5.3
.
5.4
Litigation
. There are no suits or proceedings pending or, to the Knowledge of
such Seller, threatened before any court or by or before any governmental or regulatory authority,
commission, bureau or agency or public regulatory body against such Seller which, if adversely
determined, would interfere with such Sellers ability to consummate the transactions contemplated
hereby.
17
5.5
Related Parties
. Except as set forth on
Schedule 5.5
, and except for The
Scripps Research Institute (
TSRI
) and its Affiliates, neither such Seller, nor, if
applicable, any current officer or member of the Board of Directors of such Seller (a) owns,
directly or indirectly, any significant interest in, or is a director, officer, employee,
consultant or agent of, any Person which is a competitor of the Company; (b) owns, directly or
indirectly, in whole or in part, any property, asset or right, real, personal or mixed, tangible or
intangible that is material to the business, financial condition, prospects or results of
operations of the Company taken as a whole; or (c) has an interest in or is, directly or
indirectly, a party to any Contract.
5.6
Consent to Merger and Merger Agreement
.
Each of the undersigned Shareholders
hereby approves and consents to the Merger and approves the terms of the conditions of the Merger
set forth in this Merger Agreement, which is also hereby approved. The consent and approval of the
Shareholders set forth herein constitutes the approval by the Shareholders of the Company required
for the Merger pursuant to Sections 251 and 264 of the DGCL.
ARTICLE 6
Additional Agreements
6.1
Investigation; Notices
.
The representations, warranties and covenants set forth
in this Agreement shall not be affected or diminished in any way by any investigation (or failure
to investigate) at any time by or on behalf of the party for whose benefit such representations,
warranties and covenants were made. All statements contained herein or in any schedule,
certificate, exhibit, list or other document delivered pursuant hereto shall be deemed to be
representations and warranties for purposes of this Agreement.
6.2
Survival of the Representations and Warranties
.
The representations, warranties
and covenants of each party set forth in this Agreement shall survive the Closing Date for a period
of ***, except that (a) the representations set forth in
Sections 4.14
(Tax Matters),
4.19
(Environmental), and
4.20
(Employment Matters) shall survive until the
expiration of the applicable statute of limitation, and (b) the representations set forth in
Sections 3.2
(Authorization),
4.2
(Authorization),
4.6
(Capitalization),
5.1
(Title) and
5.2
(Authorization) shall survive indefinitely.
6.3
General Release
.
As additional consideration for the sale of the Securities
pursuant to this Agreement, each of the Sellers hereby unconditionally and irrevocably releases and
forever discharges, effective as of the Effective Time, and conditioned upon payment of the Merger
Consideration and the Effective Time Payables, the Company and its officers, directors, employees,
agents and each of the other Sellers, from any and all rights, claims, demands, judgments,
obligations, liabilities and damages, whether accrued or unaccrued, asserted or unasserted,
and whether known or unknown, relating to the Company which ever existed, now exist, or may
hereafter exist, by reason of any tort, breach of contract, violation of law or other act or
failure to act which shall have occurred at or prior to the Closing Date, or in relation to any
other liabilities of the Company to such Seller. Notwithstanding the foregoing, nothing herein
shall affect the rights and liabilities of the parties pursuant to that certain License Agreement,
dated as of June 16, 2008, between the Company and TSRI, as amended (the
TSRI License
).
The Sellers expressly intend that the foregoing release shall be effective regardless of whether
the basis for any claim or right hereby released shall have been known to or anticipated by the
Sellers.
18
6.4
Indemnification
.
(a) Subject to
Sections 6.2
, the Sellers agree to indemnify and hold harmless Buyer,
Merger Sub and their Affiliates and their respective directors, officers, employees and agents
from, against and in respect of (i) any and all Liabilities, arising from any breach or violation
of any of the representations and warranties of the Company or the Sellers contained in this
Agreement or in any schedule, exhibit or attachment hereto, except that TSRI shall have no
liability under this Section 6.4(a)(i), or (ii) as to each Seller severally and not jointly, any
and all Liabilities arising from any breach or violation of the covenants or agreements of such
Seller contained in this Agreement (such Liabilities being herein referred to as Buyers
Indemnifiable Losses). The obligations of the Sellers to indemnify the Buyer, Merger Sub and their
Affiliates for any breach of a representation or warranty contained in
ARTICLE 5
, shall be
several, not joint, and shall be the obligation only of the Seller breaching such representation or
warranty. In the event Buyers Indemnifiable Losses arise from a breach of the representations and
warranties contained in
ARTICLE 4
, the Sellers other than TSRI shall be jointly and
severally liable for the Buyers Indemnifiable Losses, provided that each *** and subject to the
limitations set forth below:
(x) ***;
(y) ***; and
(z) ***, any claims for Buyers Indemnifiable Losses shall be recoverable solely by way of ***
and not by way of separate claim against any of the properties and assets of any Seller;
provided further that the limitations set forth in
Section 6.4(a)(x)-(z)
shall not apply in
the event of actual fraud on the part of the Sellers or the Company or in the case of a breach by
the Company of the representations set forth in
Section 4.2
(Authorization) or
4.6
(Capitalization).
(b) Subject to
Sections 6.2
, Buyer and Merger Sub agree to indemnify and hold harmless
the Company, the Sellers, directors, officers, employees and agents from, against and in respect of
the full amount of any and all Liabilities, arising from (A) any breach or violation of any of the
representations and warranties of Buyer and Merger Sub contained in this Agreement or in schedule,
exhibit or attachment hereto, or any document or certificate delivered by Buyer or Merger Sub at or
prior to the Closing, or (B) any and all Liabilities arising from any breach or violation of the
covenants or agreements of Buyer and Merger Sub contained in this Agreement.
19
(c)
Indemnification Procedure as to Third Party Claims
.
(i) Promptly after Buyer obtains knowledge of the commencement of any third party claim,
action, suit or proceeding or of the occurrence of any event or the existence of any state of facts
which may become the basis of a third party claim (any such claim, action, suit or proceeding or
event or state of facts being hereinafter referred to in this
Section 6.4
as a
Claim
), in respect of which Buyer is entitled to indemnification under this Agreement,
Buyer shall notify the Seller Representative of such Claim in writing;
provided, however
,
that any failure to give notice (A) will not waive any rights of the Buyer and (B) will not relieve
the Sellers of their obligations as hereinafter provided in this
Section 6.4
after such
notice is given unless the Sellers are materially adversely affected thereby. With respect to any
Claim as to which such notice is given, the Sellers will assume the defense or otherwise settle
such Claim with counsel reasonably satisfactory to Buyer and experienced in the conduct of Claims
of that nature at the Sellers sole risk and expense;
provided, however
, that Buyer (1)
shall be permitted to join the defense and settlement of such Claim and to employ counsel
reasonably satisfactory to it at its expense, and (2) shall cooperate fully with the Sellers in the
defense and any settlement of such Claim in any manner reasonably requested by the Sellers. The
Sellers shall not make any settlement of any claims without the written consent of Buyer, which
shall not be unreasonably withheld or delayed. Without limiting the generality of the foregoing, it
shall not be deemed unreasonable to withhold consent to a settlement involving injunctive or other
equitable relief against Buyer or its Affiliates or their assets, employees or business.
(ii) If the Sellers fail to assume the defense of such Claim or, having assumed the defense
and settlement of such Claim, fails reasonably to contest such Claim in good faith, or the remedy
sought by the claimant with respect to such Claim is not solely for money damages, Buyer, without
waiving its right to indemnification, may, but is not required to, assume the defense and
settlement of such Claim at Sellers expense;
provided, however
, that (A) the Sellers shall
cooperate with Buyer in the defense and settlement of such Claim in any manner reasonably requested
by Buyer, and (B) Buyer shall not settle such Claim without the written consent of the Sellers,
which consent shall not be unreasonably withheld or delayed.
(d)
Prompt Payment
. With regard to claims for which indemnification is payable
hereunder, such indemnification shall be paid promptly by the Sellers or Buyer upon demand by Buyer
or the Sellers, as the case may be.
6.5
Confidentiality
.
The Sellers acknowledge that the Intellectual Property and all
other confidential or proprietary information with respect to the business and operations of the
Company are valuable, special and unique. The Sellers shall not, at any time after the Closing
Date, disclose, directly or indirectly, to any Person, or use or purport to authorize any Person to
use any Intellectual Property, confidential or proprietary information with respect to the Company
or Buyer, whether or not for the Sellers own benefit, without the prior written consent of Buyer,
including without limitation, information as to the financial condition, results of operations,
customers, suppliers, products, products under development, inventions, sources, leads or methods
of obtaining new products or business, Intellectual Property, pricing methods or formulas, cost of
supplies, marketing strategies or any other information relating to the Company or Buyer which
could reasonably be regarded as confidential, but not including information which is or shall
become generally available to the public other than as a result of an unauthorized disclosure by a
Seller or its representatives. Nothing in this
Section 6.5
shall in any way alter the
rights or obligations of the
parties under the TRSI License or with respect to the information disclosed or available
pursuant to the TSRI License or the Use Agreement, dated July 20, 2010, but effective as of
November 1, 2009 (the
OPKO Use Agreement
) between TSRI and Buyer. The Sellers acknowledge
that Buyer would not enter into this Agreement without the assurance that all such confidential and
proprietary information will be used for the exclusive benefit of the Company and the Surviving
Entity.
20
6.6
Continuing Obligations
.
The restrictions set forth in
Section 6.5
are
considered by the parties to be reasonable for the purposes of protecting the value of the business
and goodwill of the Company and Buyer. Buyer and the Sellers acknowledge that Buyer would be
irreparably harmed and that monetary damages would not provide an adequate remedy to Buyer in the
event the covenants contained in
Section 6.5
were not complied with in accordance with
their terms. Accordingly, the Sellers agree that any breach or threatened breach by any of them of
any provision of
Section 6.5
shall entitle Buyer to injunctive and other equitable relief
to secure the enforcement of these provisions, without posting a bond, in addition to any other
remedies which may be available to Buyer, and that Buyer shall be entitled to receive from the
Sellers reimbursement for all reasonable attorneys fees and expenses incurred by Buyer in
enforcing these provisions
ARTICLE 7
Closing
7.1
Closing
.
The transfers and deliveries to be made pursuant to this Agreement shall
take place on the Closing Date at the offices of the Buyer at 4400 Biscayne Boulevard, Miami,
Florida 33137 (the
Closing
). All proceedings to be taken and all documents to be executed
at the Closing shall be deemed to have been taken, delivered and executed simultaneously, and no
proceeding shall be deemed taken nor documents deemed executed or delivered until all have been
taken, delivered and executed.
(a) At Closing, the Company shall deliver to Buyer (i) all of the certificates representing
the Securities indicated next to each Shareholders name on
Schedule 2.3(b)(i)
, (ii)
written agreements from each of the Optionholders evidencing the consent of each such Optionholder
to accept the Merger Consideration payable hereunder in exchange for the termination and
cancellation of the Securities indicated next to such Optionholders name on
Schedule
2.3(b)(ii)
, (iii) the effective written resignations of such of the directors and officers of
the Company as may be requested by Buyer, and (iv) such other documents and instruments as Buyer
may reasonably request.
(b) At Closing, Buyer (i) shall deliver the Closing Date Payment portion of the Merger
Consideration in accordance with
Section 2.3(b)
, and (ii) the amounts required for
satisfaction of the Notes and the Effective Time Payables, as provided in
Sections 2.3(c)
and
2.3(d)
.
(c) At Closing, the Company shall deliver to Buyer the canceled Notes and all consents and
approvals of governmental authorities and other Persons required to consummate the transactions
contemplated by this Agreement (including without limitation the consent and approval of its Board
of Directors and Shareholders), each of which shall have been obtained without the imposition of
any adverse terms or condition which would adversely affect Buyer or its ability to operate the
Company after the Closing.
ARTICLE 8
Sellers Representative
8.1
Sellers Representative
.
21
(a) Each Seller, by virtue of his, her or its execution of this Agreement, shall be deemed to
have consented and agreed to the appointment, effective as of the Closing Date, of KUR, LLC as the
Sellers Representative for purposes of this Agreement, as attorneys-in-fact for such Seller, with
full power of substitution and authority to:
(i) approve the allocation of funds and payment instructions, and the other terms and
conditions set forth in the Paying Agent Agreement;
(ii) execute any amendment or waiver of this Agreement and any other document or instrument
necessary or advisable in order to carry out the provisions of this Agreement;
(iii) to give and receive notices and communications;
(iv) to dispute any claim for indemnification hereunder;
(v) to agree to, negotiate, enter into settlements and compromises of, any dispute or claims
of Buyers Indemnifiable Losses,
and to take all actions necessary or appropriate in the judgment of the Sellers Representative for
the accomplishment of the foregoing; provided, however, that the Sellers Representative shall not
have the power or authority to execute an amendment, waiver, document or other instrument that,
notwithstanding any other provision to the contrary, increases in any respect the obligations or
liabilities of any Seller without the prior written consent of such Seller. KUR, LLC hereby
consents and agrees to such appointment pursuant to this
Section 8.1
. Buyer may rely
conclusively on any actions taken by Joseph Collard or his designee appointed in writing on behalf
of the Sellers Representative, as an authorized action of the Sellers Representative.
(b) In all matters relating to this
ARTICLE 8
, the Sellers Representative shall be
the only party entitled to assert the rights of Seller Indemnified Persons. The Sellers shall be
bound by all actions taken by the Sellers Representative in its capacity as such. Buyer is
authorized to rely conclusively on any such action of the Sellers Representative as being the duly
authorized action of the Sellers and no party shall have any cause of action against Buyer for any
action taken by Buyer in reliance upon the instructions, decisions or actions of the Sellers
Representative. The Buyer shall be entitled to rely on all statements, representations, decisions
and actions of the Sellers Representative.
(c) The Sellers Representative shall promptly provide written notice to the Sellers of any
action taken on their behalf by the Sellers Representative pursuant to the authority delegated to
the Sellers Representative under this
ARTICLE 8
. The Sellers Representative shall at all
times act in his or her capacity as Sellers Representative in a manner that the Sellers
Representative believes
to be in the best interests of the Sellers. Neither the Sellers Representative, nor any of
its directors, officers, agents or employees, if any, shall be liable to any Person for any error
of judgment, or any action taken, suffered or omitted to be taken, under this Agreement, except in
the case of its gross negligence, bad faith or willful misconduct. The Sellers Representative may
consult with legal counsel, independent public accountants and other experts selected by him or her
and shall not be liable for any action taken or omitted to be taken in good faith by him or her in
accordance with the advice of such counsel, accountants or experts. The Sellers Representative
shall not have any duty to ascertain or to inquire as to the performance or observance of any of
the terms, covenants or conditions of this Agreement. As to any matters not expressly provided for
in this Agreement, the Sellers Representative shall not exercise any discretion or take any
action.
22
8.2
Capitalization of Sellers Representative
.
Each of the Sellers, by execution of
this Agreement, confirms that such Seller has subscribed for and accepted a members interest in
Sellers Representative in exchange for the transfer and assignment to Sellers Representative of
such Sellers right, title and interest in and to the Deferred Merger Consideration, such members
interest to be initially issued pro rata based on such Sellers Percentage Interest in the Merger
Consideration. Each Seller agrees to execute and deliver such documentation, and to take such
actions, as may be reasonably requested by the Board of Managers of Sellers Representative to
confirm such transfer and assignment and the acceptance if such members interest in consideration
of such transfer and assignment.
ARTICLE 9
Miscellaneous
9.1
Further Assurances
.
The parties agree to deliver any and all other instruments or
documents required to be delivered pursuant to, or necessary or proper in order to give effect to,
the provisions of this Agreement.
9.2
Publicity
.
The parties agree to cooperate in issuing any press release or other
public announcement concerning this Agreement or the transactions contemplated hereby. Nothing
contained herein shall prevent any party from at any time furnishing any information to any
governmental authority which it is by law or otherwise so obligated to disclose or from making any
disclosure which its counsel deems necessary or advisable in order to fulfill such partys
disclosure obligations under applicable Law or the rules of the SEC or any exchange on which a
companys securities are traded.
9.3
Assignment of Rights
.
The Company shall, without the payment of any additional
consideration by Buyer or Merger Sub, take all such actions as may be required to transfer all of
its right, title and interest in and to all assets, Intellectual Property, contracts, agreements or
other rights which are utilized by or for the benefit of the Company in the conduct of its
respective business so as to ensure that all such rights, title and interest inure to the benefit
of the Merger Sub.
9.4
Notices
.
Any notice or other communication under this Agreement shall be in
writing and shall be delivered personally or sent by certified mail, return receipt requested,
postage prepaid, or sent by facsimile or prepaid overnight courier to the parties at the addresses
set forth below their names on the signature pages of this Agreement (or at such other addresses as
shall be
specified by the parties by like notice), and with respect to the Shareholders and
Optionholders, to the addresses set forth on
Schedules 2.3(b)(i)
and
2.3(b)(ii)
.
Such notices, demands, claims and other communications shall be deemed given when actually received
or (a) in the case of delivery by overnight service with guaranteed next day delivery, the next day
or the day designated for delivery, (b) in the case of facsimile, the date upon which the
transmitting party received confirmation of receipt by facsimile, telephone or otherwise. A copy of
any notices delivered to Buyer shall also be sent to OPKO Health, Inc., 4400 Biscayne Boulevard,
Miami, Florida 33137, Attn: Kate Inman, Deputy General Counsel, Fax (305) 575-4140. A copy of any
notices delivered to any Seller or to the Sellers Representative shall also be sent to Edwards
Angell Palmer & Dodge, LLP, 525 Okeechobee Blvd, Suite 1600,West Palm Beach, FL 33401, Attn:
Jonathan E. Cole.
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9.5
Entire Agreement
.
This Agreement, its schedules and exhibits, contain every
obligation and understanding between the parties relating to the subject matter hereof, merges all
prior discussions, negotiations and agreements, if any, between them relating to the subject matter
hereof, and none of the parties shall be bound by any representations, warranties, covenants, or
other understandings, other than as expressly provided or referred to herein or therein. The
parties acknowledge that the execution and delivery of this Agreement shall not in any manner
affect the TSRI License and the OPKO Use Agreement, which shall continue in effect in accordance
with their respective terms.
9.6
Assignment
.
This Agreement may not be assigned by any party without the written
consent of the other party; provided that Buyer may assign this Agreement to an Affiliate, whether
such Affiliate currently exists or is formed in the future. This Agreement shall be binding upon
and inure to the benefit of the parties hereto and their respective successors, heirs, personal
representatives, legal representatives, and permitted assigns.
9.7
Waiver and Amendment
.
Any representation, warranty, covenant, term or condition
of this Agreement which may legally be waived, may be waived, or the time of performance thereof
extended, at any time by the party hereto entitled to the benefit thereof, and any term, condition
or covenant hereof may be amended by the parties hereto at any time. Any such waiver, extension or
amendment shall be evidenced by an instrument in writing executed on behalf of the appropriate
party by a person who, to the extent applicable, has been authorized by its Board of Directors to
execute waivers, extensions or amendments on its behalf. No waiver by any party hereto, whether
express or implied, of its rights under any provision of this Agreement shall constitute a waiver
of such partys rights under such provisions at any other time or a waiver of such partys rights
under any other provision of this Agreement. No failure by any party hereto to take any action
against any breach of this Agreement or default by another party shall constitute a waiver of the
former partys right to enforce any provision of this Agreement or to take action against such
breach or default or any subsequent breach or default by such other party.
9.8
No Third Party Beneficiary
.
Nothing expressed or implied in this Agreement is
intended, or shall be construed, to confer upon or give any Person other than the parties hereto
and their respective heirs, personal representatives, legal representatives, successors and
permitted assigns, any rights or remedies under or by reason of this Agreement.
9.9
Severability
.
In the event that any one or more of the provisions contained in
this Agreement shall be declared invalid, void or unenforceable, the remainder of the provisions of
this Agreement shall remain in full force and effect, and such invalid, void or unenforceable
provision shall be interpreted as closely as possible to the manner in which it was written.
9.10
Expenses
.
Each party agrees to pay, without right of reimbursement from the
other party, the costs incurred by it incident to the performance of its obligations under this
Agreement and the consummation of the transactions contemplated hereby, including, without
limitation, costs incident to the preparation of this Agreement, and the fees and disbursements of
counsel, accountants and consultants employed by such party in connection herewith.
24
9.11
Headings
.
The section and other headings contained in this Agreement are for
reference purposes only and shall not affect the meaning or interpretation of any provisions of
this Agreement.
9.12
Counterparts
.
This Agreement may be executed in any number of counterparts, each
of which shall be deemed an original but all of which together shall constitute one and the same
instrument.
9.13
Litigation; Prevailing Party
.
In the event of any litigation with regard to this
9.14
Agreement, the prevailing party shall be entitled to receive from the non-prevailing
party and the non-prevailing party shall pay upon demand all reasonable fees and expenses of
counsel for the prevailing party.
9.15
Injunctive Relief
.
It is possible that remedies at law may be inadequate and,
therefore, the parties hereto shall be entitled to equitable relief including, without limitation,
injunctive relief, specific performance or other equitable remedies in addition to all other
remedies provided hereunder or available to the parties hereto at law or in equity.
9.16
Governing Law
.
This Agreement has been entered into and shall be construed and
enforced in accordance with the laws of the State of Florida without reference to the choice of law
principles thereof.
9.17
Jurisdiction and Venue
.
This Agreement shall be subject to the exclusive
jurisdiction of the state and federal courts of Broward County, Florida. The parties to this
Agreement irrevocably, unconditionally, and expressly agree to submit to the jurisdiction of the
courts of the State of Florida for the purpose of resolving any dispute among the parties relating
to this Agreement or the transactions contemplated hereby. The parties waive, to the fullest extent
permitted by law, any objection to jurisdiction they may now or hereafter have to the laying of
venue of any suit, action, or proceeding arising out of or relating to this Agreement or the
transactions contemplated hereby, or any judgment entered by any court in respect hereof brought in
the State of Florida, and further irrevocably waive any claim that any suit, action or proceeding
brought in Broward County, Florida has been brought in an inconvenient forum.
[Remainder of Page Intentionally Left Blank]
25
IN WITNESS WHEREOF, the parties hereto have each executed and delivered this Agreement as of the
day and year first above written.
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BUYER:
OPKO Pharmaceuticals, LLC
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By:
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Name:
Title:
4400 Biscayne Boulevard
Miami, Florida 33137
USA
Attn:
Facsimile:
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MERGER SUB:
OPKO CURNA LLC
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By:
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Name:
Title:
4400 Biscayne Boulevard
Miami, Florida 33137
USA
Attn:
Facsimile:
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SHAREHOLDERS:
JOSEPH W. COLLARD
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THE SCRIPPS RESEARCH INSTITUTE
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By:
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Name:
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Title:
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OPTIONHOLDERS
FRANK YOUNG
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COMPANY:
CURNA, INC.
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By:
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Joseph W. Collard, President
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PAYING AGENT
ANGELL CORPORATE SERVICES, INC.
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By:
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Jonathan E. Cole, President
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c/o Edwards Angell Palmer & Dodge LLP
525 Okeechobee Blvd., Suite 1600
West Palm Beach, FL 33401
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SELLERS REPRESENTATIVE
KUR, LLC
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By:
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Name:
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Joseph W. Collard
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Title:
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Manager and President
Address: 1004 Brooks Lane
Delray Beach, FL 33483
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* The Disclosure Schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation
S-K. The Company hereby undertakes to furnish supplementally copies of any of the omitted schedules
or exhibits upon request by the Securities and Exchange Commission.
29
Exhibit 10.2
THIRD AMENDED AND RESTATED
SUBORDINATED NOTE AND SECURITY AGREEMENT
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$12,000.000
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Dated as of February 22, 2011
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FOR VALUE RECEIVED, OPKO Health, Inc., a Delaware corporation with offices at 4400 Biscayne
Blvd., Miami, Florida 33137 (
Borrower
), pursuant to this Third Amended and Restated
Subordinated Note and Security Agreement (this
Third Amended and Restated Note
), hereby
promises to pay to The Frost Group, LLC, a Florida limited liability company (
Lender
) at
such place as Lender may designate from time to time in writing, in lawful money of the United
States of America, the principal amount of $12,000,000, or such lesser amount as shall equal the
outstanding principal balance of the loan (the
Loan
) made to Borrower by Lender pursuant
to the Credit Agreement, dated as of March 27, 2007, as amended by that certain Amendment No. 1 to
Credit Agreement dated November 6, 2008, and Amendment No. 2 to Credit Agreement dated the date
hereof, by and among Borrower, Lender and OPKO Pharmaceuticals, LLC (formerly known as Acuity
Pharmaceuticals, LLC) (the
Amended Credit Agreement
), and to pay all other amounts due
with respect to the Loan on the dates and in the amounts set forth in the Amended Credit Agreement
and this Third Amended and Restated Note. This Third Amended and Restated Note amends, restates
and replaces in all respects the Subordinated Note and Security Agreement of Acuity
Pharmaceuticals, Inc., dated as of January 11, 2007, the obligations under which were assumed by
Borrower pursuant to the original Credit Agreement, as well as the Amended and Restated
Subordinated Note and Security Agreement dated as of March 27, 2007 and the Second Amended and
Restated Note and Security Agreement dated November 6, 2008.
1.
Definitions
. All capitalized terms used, but not defined herein, shall have the
meanings ascribed to them in the Amended Credit Agreement. In addition, the terms set forth below
shall have the following meanings:
(a)
Affiliate
means any Person that owns or controls directly or indirectly ten
percent (10%) or more of the stock of another entity, any Person that controls or is controlled by
or is under common control with such Persons or any Affiliate of such Persons and each of such
Persons officers, directors, joint venturers or partners.
(b)
Code
means the Uniform Commercial Code as adopted and in effect in the State of
Florida, as amended from time to time;
provided that
if by reason of mandatory provisions
of law, the creation and/or perfection or the effect of perfection or nonperfection of the
security interest in any Collateral is governed by the Uniform Commercial Code as in effect in a
jurisdiction other than Florida, the term
Code
shall also mean the Uniform Commercial
Code as in effect from time to time in such jurisdiction for purposes of the provisions hereof
relating to such creation, perfection or effect of perfection or non-perfection.
(c)
Equity Securities
of Borrower means (1) all common stock, preferred stock,
participations, shares, partnership interests, membership interests or other equity interests in
and of Borrower (regardless of how designated and whether or not voting or nonvoting) and (2) all
warrants, options and other rights to acquire any of the foregoing.
(d)
Event of Default
shall mean the occurrence of one or more of the following
events:
(1) Borrower shall fail to make any payment due to Lender under this Third Amended and
Restated Note when the same shall become due and payable, whether at maturity, by acceleration or
otherwise, within five days after receipt of written notice from Lender that such payment is due
and unpaid.
(2) Borrower violates any of the covenants contained in Sections 7 and 8 of this Third
Amended and Restated Note and fails to remedy such violation within ten (10) days after receipt of
written notice from Lender that such a violation has occurred.
(3) Any material portion of Borrowers assets is attached, seized, subjected to a writ or
distress warrant, or is levied upon, or comes into the possession of any trustee, receiver or
person acting in a similar capacity and such attachment, seizure, writ or distress warrant or levy
has not been removed, discharged or rescinded within ten (10) days, or if Borrower is enjoined,
restrained, or in any way prevented by court order from continuing to conduct all or any material
part of its business affairs, or if a judgment or other claim becomes a lien or encumbrance upon
any material portion of Borrowers assets, or if a notice of lien, levy, or assessment is filed of
record with respect to any of Borrowers assets by the United States Government, or any
department, agency, or instrumentality thereof, or by any state, county, municipal, or
governmental agency, and the same is not paid within ten (10) days after Borrower receives notice
thereof; provided that none of the foregoing shall constitute an Event of Default where such
action or event is stayed or an adequate bond has been posted pending a good faith contest by
Borrower.
(4) One or more defaults shall exist under any agreement with any third party or parties
which consists of the failure to pay any Indebtedness at maturity or which results in a right by
such third party or parties, whether or not exercised, to accelerate the maturity of Indebtedness
in an aggregate amount in excess of One Hundred Fifty Thousand Dollars ($150,000).
(5) A judgment or judgments for the payment of money in an amount, individually or in the
aggregate, of at least One Hundred Fifty Thousand Dollars ($150,000) shall be rendered against
Borrower and shall remain unsatisfied and unstayed for a period often (10) days or more.
(6) Any material misrepresentation or material misstatement that exists now or hereafter in
any warranty, representation, statement, certification, or report made to Lender by Borrower or
any officer, employee, agent, or director of Borrower shall prove to have been false or misleading
in any material respect when made or furnished.
(7) Any document executed in connection with the Loan ceases to be, or Borrower asserts that
such document is not, in any material respect, a legal, valid and binding obligation of Borrower
enforceable in accordance with its terms.
(8) A proceeding shall have been instituted in a court having jurisdiction in the premises
seeking a decree or order for relief in respect of Borrower in an involuntary case under any
applicable bankruptcy, insolvency or other similar law now or hereafter in effect, or for the
appointment of a receiver, liquidator, assignee, custodian, trustee (or similar official) of
Borrower or for any substantial part of its property, or for the winding-up or liquidation of its
affairs, and such proceeding shall remain undismissed or unstayed and in
effect for a period of sixty (60) consecutive days or such court shall enter a decree or
order granting the relief sought in such proceeding.
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(9) Borrower commences a voluntary case under any applicable bankruptcy, insolvency or other
similar law now or hereafter in effect, consents to the entry of an order for relief in an
involuntary case under any such law, or consents to the appointment of or taking possession by a
receiver, liquidator, assignee, trustee, custodian (or other similar official) of Borrower or for
any substantial part of its property, or shall make a general assignment for the benefit of
creditors, or shall fail generally to pay its debts as they become due, or shall take any
corporate action in furtherance of any of the foregoing.
(e)
Indebtedness
means, with respect to Borrower, the aggregate amount of, without
duplication, (a) all obligations of Borrower for borrowed money, (b) all obligations of Borrower
evidenced by bonds, debentures, notes or other similar instruments, (c) all obligations of
Borrower to pay the deferred purchase price of property or services (excluding trade payables aged
less than one hundred eighty (180) days), (d) all capital lease obligations of Borrower, (e) all
obligations or liabilities of others secured by a Lien on any asset of Borrower, whether or not
such obligation or liability is assumed, (t) all obligations or liabilities of others guaranteed
by Borrower, and (g) any other obligations or liabilities which are required by GAAP to be shown
as debt on the balance sheet of Borrower.
(f)
Intellectual Property
means all of Borrowers right, title and interest in and
to patents, patent rights (and applications and registrations therefor), trademarks and service
marks (and applications and registrations therefor), inventions, copyrights, mask works (and
applications and registrations therefor), trade names, trade styles, software and computer
programs, source code, object code, trade secrets, methods, processes, know how, drawings,
specifications, descriptions, and all memoranda, notes, and records with respect to any research
and development, all whether now owned or subsequently acquired or developed by Borrower and
whether in tangible or intangible form or contained on magnetic media readable by machine together
with all such magnetic media (but not including embedded computer programs and supporting
information included within the definition of goods under the Code).
(g)
Lien
means any voluntary or involuntary security interest, pledge, bailment,
lease, mortgage, hypothecation, conditional sales and title retention agreement, encumbrance or
other lien with respect to any property of the Borrower in favor of any person.
(h)
Permitted Indebtedness
means and includes:
(1) Indebtedness of Borrower to Lender;
(2) Indebtedness arising from the endorsement of instruments in the ordinary course of
business;
(3) Indebtedness existing on the date hereof and disclosed in the Schedule of Exceptions to
the Amended Credit Agreement or in the financial statements included with the Companys periodic
reports filed with the SEC;
(4) Indebtedness of Borrower in an aggregate original principal amount not to exceed $250,000
which is secured by Liens permitted under clause (5) of the definition of Permitted Liens;
-3-
(5) Other Indebtedness in an aggregate amount not exceeding $500,000 at any time; and
(6) Extensions, refinancings, modifications, amendments and restatements of any items of
Permitted Indebtedness above, provided that the principal amount thereof is not increased or the
terms thereof are not modified to impose more burdensome terms upon Borrower.
(i)
Permitted Investments
means and includes any of the following investments:
(1) Deposits and deposit accounts with commercial banks organized under the laws of the
United States or a state thereof to the extent: (i) the deposit accounts of each such institution
are insured by the Federal Deposit Insurance Corporation up to the legal limit; and (ii) each such
institution has an aggregate capital and surplus of not less than One Hundred Million Dollars
($100,000,000).
(2) Investments in marketable obligations issued or fully guaranteed by the United States and
maturing not more than one (l) year from the date of Issuance.
(3) Investments in open market commercial paper rated at least A1 or P1 or higher by a
national credit rating agency and maturing not more than one (1) year from the creation thereof.
(4) Investments pursuant to or arising under currency agreements or interest rate agreements
entered into in the ordinary course of business.
(5) Investments, not requiring the use of cash or the assumption of liabilities, in joint
ventures, partnerships or similar business arrangements entered into in the ordinary course of
business in substantially the same industry and growth stage as Borrower.
(6) Other investments aggregating not In excess of Five Hundred Thousand Dollars ($500,000)
at any time.
(j)
Permitted Liens
means:
(1) The Lien created by this Agreement.
(2) Liens for fees, taxes, levies, imposts, duties or other governmental charges of any kind
which are not yet delinquent or which are being contested in good faith by appropriate proceedings
which suspend the collection thereof
(provided that
such appropriate proceedings do not
involve any substantial danger of the sale, forfeiture or loss of any material item of Collateral
or Collateral which in the aggregate is material to Borrower and that Borrower has adequately
bonded such Lien or reserves sufficient to discharge such Lien have been provided on the books of
Borrower).
-4-
(3) Liens existing as of the date of this Third Amended and Restated Note and identified in
the Schedule of Exceptions to the Amended Credit Agreement.
(4) carriers, warehousemens, mechanics, materialmens, repairmens or other similar Liens
arising in the ordinary course of business and which are not delinquent or remain payable without
penalty or which are being contested in good faith and by appropriate proceedings
(provided
that
such appropriate proceedings do not involve any substantial danger of the sale,
forfeiture or loss of any material item of Collateral or Collateral which in the aggregate is
material to Borrower and that Borrower has adequately bonded such Lien or reserves sufficient to
discharge such Lien have been provided on the books of Borrower).
(5) Liens upon any equipment or other personal property acquired by Borrower after the date
hereof to secure (i) the purchase price of such equipment or other personal property, or (ii)
lease obligations or indebtedness incurred solely for the purpose of financing the acquisition of
such equipment or other personal property; provided that such Liens are confined solely to the
equipment or other personal property so acquired and the proceeds thereof and the amount secured
does not exceed the acquisition price thereof.
(6) licenses of Intellectual Property entered into in the ordinary course of business
(whether as licensor or licensee);
(7) bankers liens, rights of setoff and similar Liens incurred on deposits made in the
ordinary course of business and Liens in favor of financial institutions arising in connection
with Borrowers deposit accounts or securities accounts held at such institutions to secure
customary fees and charges;
(8) any judgment, attachment or similar Lien not resulting in an Event of Default hereunder;
and
(9) Liens incurred in the extension, renewal or refinancing of the indebtedness secured by
Liens described above but any extension, renewal or replacement Lien must be limited to the
property encumbered by the existing Lien and the principal amount of the indebtedness may not
increase.
(k)
Person
means and includes any individual, any partnership, any corporation, any
business trust, any joint stock company, any limited liability company, any unincorporated
association or any other entity and any domestic or foreign national, state or local government,
any political subdivision thereof, and any department, agency, authority or bureau of any of the
foregoing.
(l)
Subsidiary
means any corporation or other entity of which a majority of the
outstanding equity securities entitled to vote for the election of directors or other governing
body (otherwise than as the result of a default) is owned by Borrower directly or indirectly
through Subsidiaries.
(m)
Warrant
means the warrant to acquire 4,000,000 shares of Common Stock of
Borrower, dated as of March 27, 2007, issued to Lender.
2.
Payments of Principal, Interest, Etc.
The principal amount of the Loan evidenced
hereby, together with any accrued and unpaid interest, and any and all unpaid costs, fees and
expenses accrued, shall be due and payable on March 31, 2012 (the
Maturity Date
).
-5-
3.
Interest.
All amounts outstanding from time to time hereunder shall bear interest
until such amounts are paid, at the Interest Rate (as defined in the Amended Credit Agreement).
Following any Event of Default (including before or after any judgment is entered) and after the
Maturity Date, the principal balance outstanding hereunder, together with all such other amounts
outstanding hereunder, shall bear interest at a rate per annum equal to the Default Rate (as
defined in the Amended Credit Agreement).
4.
Prepayments.
Borrower may prepay in cash, at any time or from time to time, all or
any portion of the amounts due hereunder, without penalty or premium;
provided, however,
that any
prepayment (whether voluntary or involuntary) shall be applied first to accrued and unpaid
interest and second to outstanding principal and other sums due hereunder.
5.
Security Interest
.
(a)
Grant of Security Interest.
Borrower grants to Lender a valid and continuing
security interest in all presently existing and hereafter acquired or arising Collateral in order
to secure prompt, full and complete payment of the amounts due hereunder and in order to secure
prompt, full and complete performance by Borrower of each of its covenants and duties under the
Amended Credit Agreement and this Third Amended and Restated Note. The
Collateral
shall
mean and include all right, title, interest, claims and demands of Borrower in and to all personal
property of Borrower located within the United States, including without limitation, all of the
following:
(1) All goods (and embedded computer programs and supporting information included within the
definition of goods under the Code) and equipment now owned or hereafter acquired, including,
without limitation, all laboratory equipment, computer equipment, office equipment, machinery,
fixtures, vehicles (including motor vehicles and trailers), and any interest in any of the
foregoing, and all attachments, accessories, accessions, replacements, substitutions, additions,
and improvements to any of the foregoing, wherever located.
(2) All inventory now owned or hereafter acquired, including, without limitation, all
merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and
finished products including such inventory as is temporarily out of Borrowers custody or
possession or in transit and including any returns upon any accounts or other proceeds, including
insurance proceeds, resulting from the sale or disposition of any of the foregoing and any
documents of title representing any of the above, and Borrowers books relating to any of the
foregoing.
(3) All contract rights and general intangibles (except to the extent included within the
definition of Intellectual Property), now owned or hereafter acquired, including, without
limitation, goodwill, license agreements, franchise agreements, blueprints, drawings, purchase
orders, customer lists, route lists, infringements, claims, software, computer programs, computer
disks, computer tapes, literature, reports, catalogs, design rights, income tax refunds, payment
intangibles, commercial tort claims, payments of insurance and rights to payment of any kind.
-6-
(4) All now existing and hereafter arising accounts, contract rights, royalties, license
rights, license fees and all other forms of obligations owing to Borrower arising out of the sale
or lease of goods, the licensing of technology or the rendering of services
by Borrower (subject, in each case, to the contractual rights of third parties to require
funds received by Borrower to be expended in a particular manner), whether or not earned by
performance, and any and all credit insurance, guaranties, and other security therefor, as well as
all merchandise returned to or reclaimed by Borrower and Borrowers books relating to any of the
foregoing.
(5) All documents, cash, deposit accounts, letters of credit (whether or not the letter of
credit is evidenced by a writing), certificates of deposit, instruments, promissory notes, chattel
paper (whether tangible or electronic) and investment property, including, without limitation, all
securities, whether certificated or uncertificated, security entitlements, securities accounts,
commodity contracts and commodity accounts, and all financial assets held in any securities
account or otherwise, wherever located, now owned or hereafter acquired and Borrowers books
relating to the foregoing.
(6) Any and all claims, rights and interests in any of the above and all substitutions for,
additions and accessions to and proceeds thereof, including, without limitation, insurance,
condemnation, requisition or similar payments and proceeds of the sale or licensing of
Intellectual Property to the extent such proceeds no longer constitute Intellectual Property.
(7) Notwithstanding the foregoing, the Collateral shall not include any Intellectual
Property;
provided, however
, that the Collateral shall include all accounts receivables,
accounts, and general intangibles that consist of rights to payment and proceeds from the sale,
licensing or disposition of all or any part, or rights in, the foregoing (the
Rights to
Payment
). Notwithstanding the foregoing, if a judicial authority (including a U.S. Bankruptcy
Court) holds that a security interest in the underlying Intellectual Property is necessary to have
a security interest in the Rights to Payment, then the Collateral shall automatically, and
effective as of the date hereof, include the Intellectual Property to the extent necessary to
permit perfection of Lenders security interest in the Rights to Payment.
(b)
After-Acquired Property
. If Borrower shall at any time acquire a commercial tort
claim, as defined in the Code, Borrower shall immediately notify Lender in writing signed by
Borrower of the brief details thereof and grant to Lender in such writing a security interest
therein and in the proceeds thereof, all upon the terms of this Third Amended and Restated Note,
with such writing to be in form and substance satisfactory to Lender.
(c)
Duration of Security Interest.
Lenders security interest in the Collateral shall
continue until the payment in full and the satisfaction of all obligations of Borrower under this
Third Amended and Restated Note, and the termination of any commitment to fund any Loan, whereupon
such security interest shall terminate. Lender shall, at Borrowers sole cost and expense, execute
such further documents and take such further actions as may be reasonably necessary to make
effective the release contemplated by this Section 5(c). including duly executing and delivering
termination statements for filing in all relevant jurisdictions under the Code.
-7-
(d)
Location and Possession of Collateral.
The Collateral is and shall remain in the
possession of Borrower at its locations at 4400 Biscayne Blvd., 15
th
Floor, Miami,
Florida, Hialeah, Florida, and Jupiter, Florida. Borrower shall remain in full possession,
enjoyment and control of the Collateral (except only as may be otherwise required by Lender for
perfection of its security interest therein) and so long as no Event of Default has occurred
and is continuing, shall be entitled to manage, operate and use the same and each part thereof
with the rights and franchises appertaining thereto;
provided that
the possession,
enjoyment, control and use of the Collateral shall at all time be subject to the observance and
performance of the terms of this Agreement.
(e)
Delivery of Additional Documentation Required
. Borrower shall from time to time
execute and deliver to Lender, at the request of Lender, all financing statements and other
documents Lender may reasonably request, in form satisfactory to Lender, to perfect and continue
Lenders perfected security interests in the Collateral and in order to consummate fully all of
the transactions contemplated under this Third Amended and Restated Note and the Amended Credit
Agreement.
(f)
Right to Inspect.
Lender (through any of its officers, employees, or agents)
shall have the right, upon reasonable prior notice, from time to time during Borrowers usual
business hours, to inspect Borrowers books and records and to make copies thereof and to inspect,
test, and appraise the Collateral in order to verify Borrowers financial condition or the amount,
condition of, or any other matter relating to, the Collateral.
(g)
Protection of Intellectual Property.
Borrower shall use its commercially
reasonable efforts to (i) protect, defend and maintain the validity and enforceability of its
material Intellectual Property and promptly advise Lender in writing of material infringements
which become known to Borrower, and (ii) not allow any Intellectual Property material to
Borrowers business to be abandoned, forfeited or dedicated to the public except in the ordinary
course of Borrowers business.
6.
Subordination
. Lender agrees that the Liens granted to it hereunder in equipment
and other personal property acquired by Borrower after the date hereof (
Third Party
Equipment
) which secure Indebtedness constituting Permitted Indebtedness under Subclause (4)
of the definition of Permitted Indebtedness shall be subordinate to the Liens of existing or
future lenders providing equipment financing and equipment lessors for Third Party Equipment or if
such lenders prohibit the granting of Liens to other lenders, Lender shall release its Lien on
such Third Party Equipment and the proceeds thereof; provided that such Liens are confined solely
to the equipment so financed and the proceeds thereof and are Permitted Liens. Upon the expiration
of the Liens of such other lenders or the termination of their prohibition of Liens in favor of
other Lenders, the Third Party Equipment shall automatically become part of the Collateral, and
Lender is authorized at that time to amend any filed financing statement(s) to reflect that
change. Notwithstanding the foregoing, the obligations hereunder shall not be subordinate in right
of payment to any obligations to other lenders, equipment lenders or equipment lessors, and
Lenders rights and remedies hereunder shall not in any way be subordinate to the rights and
remedies of any such lenders or equipment lessors.
7.
Affirmative Covenants
. Borrower covenants that, so long as any amounts are due and
payable hereunder to Lender or any commitment to make any Loan still exists, Borrower shall:
(a) Maintain its corporate existence and its good standing in its jurisdiction of
incorporation and maintain qualification in each jurisdiction in which the failure
to so qualify could reasonably be expected to have a material adverse effect on the financial
condition, operations or business of Borrower. Borrower shall maintain in force all licenses,
approvals and agreements, the loss of which could reasonably be expected to have a material
adverse effect on its financial condition, operations or business.
-8-
(b) Comply with all statutes, laws, ordinances and government rules and regulations to which
it is subject, noncompliance with which could reasonably be expected to materially adversely
affect the financial condition, operations or business of Borrower.
(c) Deliver to Lender, promptly as they are available and in any event: (i) at the time of
filing of Borrowers Form 10-K with the Securities and Exchange Commission after the end of each
fiscal year of Borrower, the financial statements of Borrower filed with such Form 10-K; and (ii)
at the time of filing of Borrowers Form 10-Q with the Securities and Exchange Commission after
the end of each of the first three fiscal quarters of Borrower, the financial statements of
Borrower filed with such Form 10-Q. If, at any time during which any Obligations are outstanding
under this Third Amended and Restated Note, Borrower ceases to be subject to the reporting
obligations of the Securities and Exchange Act of 1934, as amended, Borrower shall deliver to
Lender (w) as soon as available, but in any event within forty five (45) days after the end of
each month, a company prepared balance sheet, income statement and cash flow statement covering
Borrowers operations during such period, certified by Borrowers president, treasurer or chief
financial officer (each, a Responsible Officer); (x) as soon as available, but in any event
within one hundred twenty (120) days after the end of Borrowers fiscal year, audited financial
statements of Borrower prepared in accordance with GAAP, together with an unqualified opinion on
such financial statements of a nationally recognized or other independent public accounting firm
reasonably acceptable to Lender; (y) as soon as available, but in any event within ninety (90)
days after the end of Borrowers fiscal year or the date of Borrowers board of directors
adoption, Borrowers operating budget and plan for the next fiscal year; and (z) such other
financial information as Lender may reasonably request from time to time. In addition, Borrower
shall deliver to Lender (i) promptly upon becoming available, copies of all statements, reports
and notices sent or made available generally by Borrower to its security holders; (ii) immediately
upon receipt of notice thereof, a report of any material legal actions pending or threatened
against Borrower or the commencement of any action, proceeding or governmental investigation
involving Borrower is commenced that is reasonably expected to result in damages or costs to
Borrower of One Hundred Fifty Thousand Dollars ($150,000) or more; and (iii) such other financial
information as Lender may reasonably request from time to time.
(d) Each time financial statements are furnished pursuant to
Section 7(c)
above,
deliver to Lender an Officers Certificate signed by a Responsible Officer in form satisfactory to
Lender, certifying such financial statements, Borrowers compliance with the terms of this Third
Amended and Restated Note and that no default or Event of Default has occurred under this Third
Amended and Restated Note.
(e) As soon as possible, and in any event within five (5) days after the discovery of a
default or an Event of Default, provide Lender with an Officers Certificate setting forth the
facts relating to or giving rise to such default or Event of Default and the action which Borrower
proposes to take with respect thereto.
-9-
(f) Make due and timely payment or deposit of all federal, state, and local taxes,
assessments, or contributions required of it by law or imposed upon any property belonging to it,
and will execute and deliver to Lender, on demand, appropriate certificates attesting to the
payment or deposit thereof; and Borrower will make timely payment or deposit of all tax payments
and withholding taxes required of it by applicable laws, including those laws concerning F.I.C.A.,
F.U.T.A., state disability, and local, state, and federal income taxes, and will, upon request,
furnish Lender with proof satisfactory to Lender indicating that Borrower has made such payments
or deposits; provided that Borrower need not make any payment if the amount or validity of such
payment is contested in good faith by appropriate proceedings which suspend the collection thereof
(provided that such proceedings do not involve any substantial danger of the sale, forfeiture or
loss of any material item of Collateral or Collateral which in the aggregate is material to
Borrower and that Borrower has adequately bonded such amounts or reserves sufficient to discharge
such amounts have been provided on the books of Borrower).
(g) Keep and maintain all items of equipment and other similar types of personal property
that form any significant portion or portions of the Collateral in good operating condition and
repair and shall make all necessary replacements thereof and renewals thereto so that the value
and operating efficiency thereof shall at all times be maintained and preserved. Borrower shall
not permit any such material item of Collateral to become a fixture to real estate or an accession
to other personal property, without the prior written consent of Lender. Borrower shall not permit
any such material item of Collateral to be operated or maintained in violation of any applicable
law, statute, rule or regulation. With respect to items of leased equipment (to the extent Lender
has any security interest in any residual Borrowers interest in such equipment under the lease),
Borrower shall keep, maintain, repair, replace and operate such leased equipment in accordance
with the terms of the applicable lease.
(h) Keep its business and the Collateral insured for risks and in amounts, and as Lender may
reasonably request. Insurance policies shall be in a form, with companies, and in amounts that are
satisfactory to Lender. All property policies shall have a lenders loss payable endorsement
showing Lender as an additional loss payee and all liability policies shall show Lender as an
additional insured and all policies shall provide that the insurer must give Lender at least
thirty (30) days notice before canceling its policy. At Lenders request, Borrower shall deliver
certified copies of policies and evidence of all premium payments. Subject to the rights of the
Senior Obligations, proceeds payable under any policy shall, at Lenders option, be payable to
Lender on account of the Obligations. Notwithstanding the foregoing, so long as no Event of
Default has occurred and is continuing, Borrower shall have the option of applying the proceeds of
any casualty policy, toward the replacement or repair of destroyed or damaged property; provided
that (i) any such replaced or repaired property (a) shall be of equal or like value as the
replaced or repaired Collateral and (b) shall be deemed Collateral in which Lender has been
granted a security interest and (ii) subject to the rights of the Senior Obligations, after the
occurrence and during the continuation of an Event of Default all proceeds payable under such
casualty policy shall, at the option of Lender, be payable to Lender, on account of the
Indebtedness evidenced by this Third Amended and Restated Note and the Amended Credit Agreement.
If Borrower fails to obtain insurance as required under Section 7(h) or to pay any amount or
furnish any required proof of payment to third persons and Lender, Lender may make all or part of
such payment or obtain such insurance policies required in Section 7(h), and take any action under
the policies Lender deems prudent. On or prior to the
Initial Closing Date and prior to each policy renewal, Borrower shall furnish to Lender
certificates of insurance or other evidence satisfactory to Lender that insurance complying with
all of the above requirements is in effect.
-10-
(i) Assuming the proper filing of one or more financing statement(s) identifying the
Collateral with the proper state and/or local authorities, the security interests in the
Collateral granted to Lender pursuant to this Agreement (i) constitute and will continue to
constitute first priority security interests (except to the extent any Permitted Liens may have a
superior priority to Lenders Lien under this Agreement) and (ii) are and will continue to be
superior and prior to the rights of all other creditors of Borrower (except to the extent of such
Permitted Liens).
(j) At any time and from time to time Borrower shall execute and deliver such further
instruments and take such further action as may reasonably be requested by Lender to make
effective the purposes of this Agreement, including without limitation, the continued perfection
and priority of Lenders security interest in the Collateral.
8.
Negative Covenants
. Borrower covenants that, so long as any amounts are due and
payable hereunder to Lender or any commitment to make any Loan still exists, without the prior
approval of Lender, Borrower shall not:
(a) Change its name, jurisdiction of incorporation, or principal place of business without
thirty (30) days prior written notice to Lender.
(b) Subject to its rights under
Section 8(d)
, remove any items of Collateral from the
Collateral location(s) specified in this Third Amended and Restated Note.
(c) Create, incur, assume or suffer to exist any Lien of any kind upon any of Borrowers
property, whether now owned or hereafter acquired, except Permitted Liens.
(d) Convey, sell, lease or otherwise dispose of all or any part of the Collateral to any
Person (collectively, a
Transfer
), except for: (i) Transfers of inventory in the
ordinary course of business; or (ii) Transfers of worn-out or obsolete equipment.
(e) Except as set forth in the Schedule of Exceptions to the Amended Credit Agreement
delivered by Borrower as of the date hereof and pursuant to obligations under its Certificate of
Incorporation, (i) pay any dividends or make any distributions on its Equity Securities; (ii)
purchase, redeem, retire, defease or otherwise acquire for value any of its Equity Securities
(other than repurchases pursuant to the terms of employee stock purchase plans, employee
restricted stock agreements or similar arrangements in an aggregate amount not to exceed One
Hundred Thousand Dollars ($100,000)); (iii) return any capital to any holder of its Equity
Securities as such; (iv) make any distribution of assets, Equity Securities, obligations or
securities to any holder of its Equity Securities as such; or (v) set apart any sum for any such
purpose;
provided
,
however
, Borrower may pay dividends payable solely in common
stock.
(f) Engage in or permit any of its Subsidiaries to engage in any business other than the
businesses currently engaged in by Borrower or reasonably related thereto.
-11-
(g) Enter into any contractual obligation with any Affiliate or engage in any other
transaction with any Affiliate except upon terms at least as favorable to Borrower as an
arms-length transaction with persons who are not Affiliates of Borrower.
(h) (i) Prepay, redeem, purchase, defease or otherwise satisfy in any manner prior to the
scheduled repayment thereof any Indebtedness for borrowed money (other than amounts due or
permitted to be prepaid under this Agreement) or lease obligations, (ii) amend, modify or
otherwise change the terms of any Indebtedness for borrowed money or lease obligations so as to
accelerate the scheduled repayment thereof or (iii) repay any notes to officers, directors or
shareholders.
(i) Create, incur, assume or permit to exist any Indebtedness except Permitted Indebtedness.
(j) Make any investment except for Permitted Investments.
(k) Become an investment company or a company controlled by an investment company under
the Investment Company Act of 1940 or undertake as one of its important activities extending
credit to purchase or carry margin stock, or use the proceeds of any Loan for that purpose; fail
to meet the minimum funding requirements of the Employment Retirement Income Security Act of 1974,
and its regulations, as amended from time to time (ERISA), permit a Reportable Event or
Prohibited Transaction, as defined in ERISA, to occur; fail to comply with the Federal Fair Labor
Standards Act or violate any other law or regulation, if the violation could reasonably be
expected to have a material adverse effect on Borrowers business or operations or could
reasonably be expected to cause a material adverse change, or permit any of its Subsidiaries to do
so.
(l) Create, incur, assume or suffer to exist any Lien of any kind upon any Intellectual
Property or Transfer any Intellectual Property, whether now owned or hereafter acquired, other
than licenses of Intellectual Property entered into in the ordinary course of business.
9.
Lenders Rights and Remedies
.
(a)
Rights and Remedies
. Upon the occurrence of an Event of Default, while such Event
of Default is continuing (provided that an Event of Default shall be continuing at all times after
any cure period therefor expires), Lender shall not have any further obligation to advance money
or extend credit to or for the benefit of Borrower. In addition, upon the occurrence and during
the continuance of an Event of Default, the entire unpaid principal sum hereunder, plus any and
all interest accrued thereon, plus all other sums due and payable to Lender hereunder shall, at
the option of Lender, become due and payable immediately without presentment, demand, notice of
nonpayment, protest, notice of protest, or other notice of dishonor, all of which are hereby
expressly waived by Borrower. Lender shall have the rights, options, duties and remedies of a
secured party as permitted by law and, in addition to and without limitation of the foregoing,
Lender may, at its election, without notice of election and without demand, do anyone or more of
the following, all of which are authorized by Borrower:
-12-
(1) Make such payments and do such acts as Lender considers necessary or reasonable to
protect Lenders security interest in the Collateral. Borrower agrees to assemble the Collateral
if Lender so requires and to make the Collateral available to Lender as Lender may designate.
Borrower authorizes Lender and its designees and agents to enter the premises where the Collateral
is located, to take and maintain possession of the Collateral, or any part of it, and to pay,
purchase, contest, or compromise any Lien which in Lenders determination appears or is claimed to
be prior or superior to its security interest and to pay all expenses incurred in connection
therewith. With respect to any of Borrowers owned premises, Borrower hereby grants Lender a
license to enter into possession of such premises and to occupy the same, without charge, for up
to one hundred twenty (120) days in order to exercise any of Lenders rights or remedies provided
herein, at law, in equity, or otherwise;
(2) Ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for
sale, and sell (in the manner provided for herein) the Collateral. Lender and its agents and any
purchasers at or after foreclosure are hereby granted a nonexclusive, irrevocable, perpetual,
fully paid, royalty-free license or other right, solely pursuant to the provisions of this Section
9, to use, without charge, Borrowers Intellectual Property, including without limitation, labels,
patents, copyrights, rights of use of any name, trade secrets, trade names, trademarks, service
marks, and advertising matter, or any property of a similar nature, now or at any time hereafter
owned or acquired by Borrower or in which Borrower now or at any time hereafter has any rights;
provided that
such license shall only be exercisable in connection with the disposition of
Collateral upon Lenders exercise of its remedies hereunder;
(3) Sell the Collateral at either a public or private sale, or both, by way of one or more
contracts or transactions, for cash or on terms, in such manner and at such places (including
Borrowers premises) as Lender determines are commercially reasonable; and
(4) Credit bid and purchase all or any portion of the Collateral at any public sale.
Any deficiency that exists after disposition of the Collateral as provided above will be paid
immediately by Borrower.
(b)
Set Off Right.
Lender may set off and apply to the obligations hereunder any and
all indebtedness at any time owing to or for the credit or the account of Borrower or any other
assets of Borrower in Lenders possession or control.
(c)
Effect of Sale
. Upon the occurrence of an Event of Default and during the
continuation thereof, to the extent permitted by law, Borrower covenants that it will not at any
time insist upon or plead, or in any manner whatsoever claim or take any benefit or advantage of,
any stay or extension law now or at any time hereafter in force, nor claim, take nor insist upon
any benefit or advantage of or from any law now or hereafter in force providing for the valuation
or appraisement of the Collateral or any part thereof prior to any sale or sales thereof to be
made pursuant to any provision herein contained, or to the decree, judgment or order of any court
of competent jurisdiction; nor, after such sale or sales, claim or exercise any right under any
statute now or hereafter made or enacted by any state or otherwise to redeem the property so sold
or any part thereof, and, to the full extent legally permitted, except as to rights
-13-
expressly provided herein, hereby expressly waives for itself and on behalf of each and every
Person, except decree or judgment creditors of Borrower, acquiring any interest in or title to the
Collateral or any part thereof subsequent to the date of this Agreement, all benefit and advantage
of any such law or laws, and covenants that it will not invoke or utilize any such law or laws or
otherwise hinder, delay or impede the execution of any power herein granted and delegated to
Lender, but will suffer and permit the execution of every such power as though no such power, law
or laws had been made or enacted. Any sale, whether under any power of sale hereby given or by
virtue of judicial proceedings, shall operate to divest all right, title, interest, claim and
demand whatsoever, either at law or in equity, of Borrower in and to the property sold, and shall
be a perpetual bar, both at law and in equity, against Borrower, its successors and assigns, and
against any and all Persons claiming the property sold or any part thereof under, by or through
Borrower, its successors or assigns.
(d)
Power of Attorney in Respect of the Collateral.
Borrower does hereby irrevocably
appoint Lender (which appointment is coupled with an interest), the true and lawful attorney in
fact of Borrower with full power of substitution, for it and in its name to file any notices of
security interests, financing statements and continuations and amendments thereof pursuant to the
Code or federal law, as may be necessary to perfect, or to continue the perfection of Lenders
security interests in the Collateral. Borrower does hereby irrevocably appoint Lender (which
appointment is coupled with an interest) on the occurrence of an Event of Default and during the
continuation thereof, the true and lawful attorney in fact of Borrower with full power of
substitution, for it and in its name: (a) to ask, demand, collect, receive, receipt for, sue for,
compound and give acquittance for any and all rents, issues, profits, avails, distributions,
income, payment draws and other sums in which a security interest is granted under
Section
5
with full power to settle, adjust or compromise any claim thereunder as fully as if Lender
were Borrower itself; (b) to receive payment of and to endorse the name of Borrower to any items
of Collateral (including checks, drafts and other orders for the payment of money) that come into
Lenders possession or under Lenders control; (c) to make all demands, consents and waivers, or
take any other action with respect to, the Collateral; (d) in Lenders discretion to file any
claim or take any other action or proceedings, either in its own name or in the name of Borrower
or otherwise, which Lender may reasonably deem necessary or appropriate to protect and preserve
the right, title and interest of Lender in and to the Collateral; (e) endorse Borrowers name on
any checks or other forms of payment or security; (f) sign Borrowers name on any invoice or bill
of lading for any account or drafts against account debtors; (g) make, settle, and adjust all
claims under Borrowers insurance policies; (h) settle and adjust disputes and claims about the
accounts directly with account debtors, for amounts and on terms Lender determines reasonable; (i)
transfer the Collateral into the name of Lender or a third party as the Code permits; and G) to
otherwise act with respect thereto as though Lender were the outright owner of the Collateral.
10.
Remedies Cumulative, Etc.
(a) No right or remedy conferred upon or reserved to Lender hereunder or now or hereafter
existing at law or in equity is intended to be exclusive of any other right or remedy, and each
and every such right or remedy shall be cumulative and concurrent, and in addition to every other
such right or remedy, and may be pursued singly, concurrently,
successively or otherwise, at the sole discretion of Lender, and shall not be exhausted by
anyone exercise thereof but may be exercised as often as occasion therefor shall occur.
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(b) Borrower hereby waives presentment, demand, notice of nonpayment, protest, notice of
protest, notice of dishonor and any and all other notices in connection with any default in the
payment of, or any enforcement of the payment of, all amounts due under this Third Amended and
Restated Note. To the extent permitted by law, Borrower waives the right to any stay of execution
and the benefit of all exemption laws now or hereafter in effect.
(c)
Costs and Expenses
. Following the occurrence of any Event of Default, Borrower
shall pay upon demand all costs and expenses (including reasonable attorneys fees and expenses)
incurred by Lender in the exercise of any of its rights, remedies or powers under this Third
Amended and Restated Note and any amount thereof not paid promptly following demand therefor shall
be added to the principal sum hereunder and shall bear interest at the Default Rate from the date
of such demand until paid in full.
11.
Indemnification and Waiver
. Whether or not the transactions contemplated hereby
shall be consummated:
(a)
General Indemnity
. Borrower agrees upon demand to payor reimburse Lender for all
liabilities, obligations and out-of-pocket expenses, including Lenders expenses and reasonable
fees and expenses of counsel for Lender from time to time arising in connection with the
enforcement or collection of sums due under this Third Amended and Restated Note or the Amended
Credit Agreement, and in connection with any amendment or modification of such documents or any
work-out in connection with such documents. Borrower shall indemnify, reimburse and hold Lender,
and each of its respective successors, assigns, agents, attorneys, officers, directors,
shareholders, servants, agents and employees (each an
Indemnified Person
) harmless from
and against all liabilities, losses, damages, actions, suits, demands, claims of any kind and
nature (including claims relating to environmental discharge, cleanup or compliance), all costs
and expenses whatsoever to the extent they may be incurred or suffered by such Indemnified Person
in connection therewith (including reasonable attorneys fees and expenses), fines, penalties (and
other charges of any applicable governmental authority), licensing fees relating to any item of
Collateral, damage to or loss of use of property (including consequential or special damages to
third parties or damages to Borrowers property), or bodily injury to or death of any person
(including any agent or employee of Borrower) (each, a Claim), directly or indirectly relating
to or arising out of the use of the proceeds of the Loans or otherwise, the falsity of any
representation or warranty of Borrower or Borrowers failure to comply with the terms of this
Third Amended and Restated Note or the Amended Credit Agreement. The foregoing indemnity shall
cover, without limitation, (i) any Claim in connection with a design or other defect (latent or
patent) in any item of equipment or product included in the Collateral, (ii) any Claim for
infringement of any patent, copyright, trademark or other intellectual property right, (iii) any
Claim resulting from the presence on or under or the escape, seepage, leakage, spillage,
discharge, emission or release of any Hazardous Substances on the premises owned, occupied or
leased by Borrower, including any Claims asserted or arising under any environmental law, or (iv)
any Claim for negligence or strict or absolute liability in tort;
provided
,
however
, Borrower shall not indemnify Lender for any liability incurred by Lender as a
direct and sole result of Lenders gross negligence or willful misconduct. Such indemnities shall
continue in full force and effect, notwithstanding the expiration or termination of this Third
Amended and Restated Note. Upon Lenders written demand, Borrower shall assume and diligently
conduct, at its sole cost and expense, the entire defense of Lender, each of its partners,
and each of their respective, agents, employees, directors, officers, shareholders,
successors and assigns against any indemnified Claim described in this Section. Borrower shall not
settle or compromise any Claim against or involving Lender without first obtaining Lenders
written consent thereto, which consent shall not be unreasonably withheld.
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12.
Notices.
All notices required to be given to any of the parties hereunder shall
be in writing and shall be deemed to have been sufficiently given for all purposes when presented
personally to such party or sent by hand delivery, facsimile, courier service guaranteeing next
business day delivery, or overnight U.S. express mail, return receipt requested, to such party at
its address set forth in the Amended Credit Agreement with copies to the parties designated to
receive copies in the Amended Credit Agreement. Such notice shall be deemed to be given when
received. Any notice of any change in such address shall also be given in the manner set forth
above. Whenever the giving of notice is required, the giving of such notice may be waived in
writing by the party entitled to receive such notice.
13.
Severability.
In the event that any provision of this Third Amended and Restated
Note is held to be invalid, illegal or unenforceable in any respect or to any extent, such
provision shall nevertheless remain valid, legal and enforceable in all such other respects and to
such extent as may be permissible. Any such invalidity, illegality or unenforceability shall not
affect any other provisions of this Third Amended and Restated Note, but this Third Amended and
Restated Note shall be construed as if such invalid, illegal or unenforceable provision had never
been contained herein.
14.
Successors and Assigns
. This Third Amended and Restated Note inures to the
benefit of Lender and binds Borrower, and their respective successors and assigns, and the words
Borrower and Lender whenever occurring herein shall be deemed and construed to include such
respective successors and assigns;
provided
,
however
, neither this Third Amended
and Restated Note nor any rights hereunder may be assigned by Borrower without Lenders prior
written consent, which consent may be granted or withheld in Lenders sole discretion.
15.
Governing Law
. This Third Amended and Restated Note shall be governed by and
construed in accordance with the laws of the State of Florida. Borrower agrees that any action or
proceeding against it to enforce the Third Amended and Restated Note may be commenced in state or
federal court in any county in the State of Florida, and Borrower waives personal service of
process and agrees that a summons and complaint commencing an action or proceeding in any such
court shall be properly served and shall confer personal jurisdiction if served by registered or
certified mail in accordance with the notice provisions set forth herein.
16.
Entire Agreement; Construction; Amendments and Waivers
.
(a)
Entire Agreement.
This Third Amended and Restated Note and each of the related
loan documents dated as of the date hereof, taken together, constitute and contain the entire
agreement between Borrower and Lender with respect to the subject matter hereof and supersede any
and all prior agreements, negotiations, correspondence, understandings and communications between
the parties, whether written or oral, with respect to such subject matter. Borrower acknowledges
that it is not relying on any representation or agreement made by Lender or any employee, attorney
or agent thereof, other than the specific agreements set forth in this Third Amended and Restated
Note and the related loan documents.
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(b)
Construction
. This Third Amended and Restated Note is the result of negotiations
between and has been reviewed by each of Borrower and Lender as of the date hereof and their
respective counsel; accordingly, this Third Amended and Restated Note shall be deemed to be the
product of the parties hereto, and no ambiguity shall be construed in favor of or against Borrower
or Lender. Borrower and Lender agree that they intend the literal words of this Third Amended and
Restated Note and the related loan documents and that no parol evidence shall be necessary or
appropriate to establish Borrowers or Lenders actual intentions.
(c)
Amendments and Waivers
. Any and all amendments, modifications, discharges or
waivers of, or consents to any departures from any provision of this Third Amended and Restated
Note or of any of the related loan documents shall not be effective without the written consent of
Lender and Borrower. Any waiver or consent with respect to any provision of such loan documents
shall be effective only in the specific instance and for the specific purpose for which it was
given. No notice to or demand on Borrower in any case shall entitle Borrower to any other or
further notice or demand in similar or other circumstances. Any amendment, modification, waiver or
consent affected in accordance with this Section shall be binding upon Lender and on Borrower.
17.
Reliance by Lender
. All covenants, agreements, representations and warranties
made herein by Borrower shall be deemed to be material to and to have been relied upon by Lender,
notwithstanding any investigation by Lender.
18.
No Set-Offs by Borrower.
All sums payable by Borrower pursuant to this Third
Amended and Restated Note or any of the related loan documents shall be payable without notice or
demand and shall be payable in United States Dollars without set-off or reduction of any manner
whatsoever.
19.
Survival.
All covenants, representations and warranties made in this Agreement
shall continue in full force and effect so long as any obligations hereunder or commitment to fund
remain outstanding. The obligations of Borrower to indemnify Lender with respect to the expenses,
damages, losses, costs and liabilities described in Section 11 shall survive until all applicable
statute of limitations periods with respect to actions that may be brought against Lender have
run.
20.
WAIVER OF TRIAL BY JURY.
EACH OF THE PARTIES HERETO HEREBY IRREVOCABL Y WAIVES,
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO TRIAL BY JURY.
SIGNATURE PAGE FOLLOWS
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IN WITNESS WHEREOF, Borrower has duly executed this Third Amended and Restated Note as of the
day and year first above written.
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OPKO HEALTH, INC.
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By:
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Name:
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Title:
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