10-Q: Quarterly report pursuant to Section 13 or 15(d)
Published on August 8, 2011
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One) |
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2011.
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission file number 001-33528
OPKO Health, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware | 75-2402409 | |
(State or Other Jurisdiction of | (I.R.S. Employer Identification No.) | |
Incorporation or Organization) |
4400 Biscayne Blvd.
Miami, FL 33137
(Address of Principal Executive Offices) (Zip Code)
Miami, FL 33137
(Address of Principal Executive Offices) (Zip Code)
(305) 575-4100
(Registrants Telephone Number, Including Area Code)
(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 o NO
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, 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 þ 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:
Large Accelerated filer o | Accelerated filer þ | Non-Accelerated filer o | Smaller Reporting Company o | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act):
YES o NO þ
As of August, 2, 2011, the registrant had 287,955,574 shares of common stock outstanding.
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EX-101 DEFINITION LINKBASE DOCUMENT |
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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:
| We have a history of operating losses and we do not expect to become profitable in the near future. | ||
| Our technologies are in an early stage of development and are unproven. | ||
| Our drug research and development activities may not result in commercially viable products. | ||
| 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. | ||
| We will require substantial additional funding, which may not be available to us on acceptable terms, or at all. | ||
| Our business is substantially dependant on our ability to develop, launch and generate revenue from our molecular diagnostic program. | ||
| 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. | ||
| If our competitors develop and market products that are more effective, safer or less expensive than our future product candidates, our commercial opportunities will be negatively impacted. | ||
| The regulatory approval process is expensive, time consuming and uncertain and may prevent us or our collaboration partners from obtaining approvals for the commercialization of some or all of our product candidates. | ||
| Failure to recruit and enroll patients for clinical trials may cause the development of our product candidates to be delayed. | ||
| Even if we obtain regulatory approvals for our product candidates, the terms of approvals and ongoing regulation of our products may limit how we manufacture and market our product candidates, which could materially impair our ability to generate anticipated revenues. | ||
| We may not meet regulatory quality standards applicable to our manufacturing and quality processes. | ||
| Even if we receive regulatory approval to market our product candidates, the market may not be receptive to our products. |
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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. | ||
| 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. | ||
| 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. | ||
| 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. | ||
| 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. | ||
| Independent clinical investigators and contract research organizations that we engage to conduct our clinical trials may not be diligent, careful or timely. | ||
| The success of our business is dependent on the actions of our collaborative partners. | ||
| 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. | ||
| If we are unable to obtain and enforce patent protection for our products, our business could be materially harmed. | ||
| 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. | ||
| 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. | ||
| We rely heavily on licenses from third parties. | ||
| We license patent rights to certain of our technology from third-party owners. If such owners do not properly maintain or enforce the patents underlying such licenses, our competitive position and business prospects will be harmed. | ||
| Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. | ||
| Adverse results in material litigation matters or governmental inquiries could have a material adverse effect upon our business and financial condition. | ||
| 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. | ||
| Failure to obtain regulatory approval outside the United States will prevent us from marketing our product candidates abroad. | ||
| We may not have the funding available to pursue acquisitions. | ||
| 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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| Non-U.S. governments often impose strict price controls, which may adversely affect our future profitability. | ||
| Our business may become subject to legal, economic, political, regulatory and other risks associated with international operations. | ||
| The market price of our common stock may fluctuate significantly. | ||
| Directors, executive officers, principal stockholders and affiliated entities own a significant percentage of our capital stock, and they may make decisions that you do not consider to be in your best interests or in the best interests of our stockholders. | ||
| Compliance with changing regulations concerning corporate governance and public disclosure may result in additional expenses. | ||
| If we are unable to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as they apply to us, or our internal controls over financial reporting are not effective, the reliability of our financial statements may be questioned and our common stock price may suffer. | ||
| We may be unable to maintain our listing on the NYSE Amex, which could cause our stock price to fall and decrease the liquidity of our common stock. | ||
| Future issuances of common stock and hedging activities may depress the trading price of our common stock. | ||
| Provisions in our charter documents and Delaware law could discourage an acquisition of us by a third party, even if the acquisition would be favorable to you. | ||
| We do not intend to pay cash dividends on our common stock in the foreseeable future. |
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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)
(unaudited)
(in thousands except share data)
June 30, 2011 | December 31, 2010 | |||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ | 38,849 | $ | 18,016 | ||||
Marketable securities |
54,998 | | ||||||
Accounts receivable, net |
15,528 | 13,317 | ||||||
Inventory, net |
16,326 | 19,957 | ||||||
Prepaid expenses and other current assets |
1,927 | 2,782 | ||||||
Total current assets |
127,628 | 54,072 | ||||||
Property and equipment, net |
3,093 | 2,729 | ||||||
Intangible assets, net |
18,545 | 9,964 | ||||||
Goodwill |
6,853 | 5,856 | ||||||
Investments |
4,240 | 5,114 | ||||||
Other assets |
60 | 111 | ||||||
Total assets |
$ | 160,419 | $ | 77,846 | ||||
LIABILITIES, SERIES D PREFERRED STOCK, AND
SHAREHOLDERS EQUITY |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | 2,890 | $ | 7,170 | ||||
Accrued expenses |
4,033 | 5,739 | ||||||
Current portion of lines of credit |
14,604 | 14,690 | ||||||
Total current liabilities |
21,527 | 27,599 | ||||||
Long-term liabilities |
1,600 | 1,067 | ||||||
Total liabilities |
23,127 | 28,666 | ||||||
Commitments and contingencies |
||||||||
Series D preferred stock $0.01 par value, 2,000,000 shares
authorized; 1,209,677 shares issued and outstanding (liquidation
value of $34,213 and $33,013) at June 30, 2011 and December 31,
2010, respectively |
26,128 | 26,128 | ||||||
Shareholders equity |
||||||||
Series A Preferred stock $0.01 par value, 4,000,000 shares
authorized; 0 and 897,439 shares issued and outstanding
(liquidation value of $0 and $2,468) at June 30, 2011 and December
31, 2010,
respectively |
| 9 | ||||||
Series C Preferred Stock $0.01 par value, 500,000 shares
authorized; No shares issued or outstanding |
| | ||||||
Common Stock $0.01 par value, 500,000,000 shares authorized;
287,946,324 and 255,412,706 shares issued and outstanding at
June 30, 2011 and December 31, 2010, respectively |
2,879 | 2,554 | ||||||
Treasury stock 2,443,894 and 45,154 shares at June 30, 2011 and
December 31, 2010, respectively |
(7,893 | ) | (61 | ) | ||||
Additional paid-in capital |
482,910 | 376,008 | ||||||
Accumulated other comprehensive income |
3,157 | 2,921 | ||||||
Accumulated deficit |
(369,889 | ) | (358,379 | ) | ||||
Total shareholders equity |
111,164 | 23,052 | ||||||
Total liabilities, Series D preferred stock, and Shareholders equity |
$ | 160,419 | $ | 77,846 | ||||
The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
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OPKO Health, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except share data)
(unaudited)
(in thousands, except share data)
For the three months ended | For the six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenue |
||||||||||||||||
Product sales |
$ | 10,130 | $ | 7,455 | $ | 18,765 | $ | 15,377 | ||||||||
Other revenue |
12 | | 25 | | ||||||||||||
Total Revenue |
10,142 | 7,455 | 18,790 | 15,377 | ||||||||||||
Cost of goods sold, excluding amortization
of intangible assets |
6,211 | 4,850 | 11,834 | 10,378 | ||||||||||||
Gross margin, excluding amortization of
intangible assets |
3,931 | 2,605 | 6,956 | 4,999 | ||||||||||||
Operating expenses |
||||||||||||||||
Selling, general and administrative |
4,919 | 5,644 | 10,505 | 9,887 | ||||||||||||
Research and development |
3,154 | 1,575 | 4,799 | 2,903 | ||||||||||||
Other operating expenses, principally
amortization of intangible assets |
1,020 | 913 | 1,900 | 1,802 | ||||||||||||
Total operating expenses |
9,093 | 8,132 | 17,204 | 14,592 | ||||||||||||
Operating loss |
(5,162 | ) | (5,527 | ) | (10,248 | ) | (9,593 | ) | ||||||||
Other expense, net |
(139 | ) | (390 | ) | (101 | ) | (730 | ) | ||||||||
Loss before
income taxes and investment |
||||||||||||||||
loss |
(5,301 | ) | (5,917 | ) | (10,349 | ) | (10,323 | ) | ||||||||
Income tax (benefit) provision |
(6 | ) | 54 | 227 | 101 | |||||||||||
Loss before investment losses |
(5,295 | ) | (5,971 | ) | (10,576 | ) | (10,424 | ) | ||||||||
Loss from investments in investees |
(451 | ) | (244 | ) | (874 | ) | (475 | ) | ||||||||
Net loss |
(5,746 | ) | (6,215 | ) | (11,450 | ) | (10,899 | ) | ||||||||
Preferred stock dividend |
(615 | ) | (661 | ) | (1,260 | ) | (1,323 | ) | ||||||||
Net loss attributable to common
Shareholders |
$ | (6,361 | ) | $ | (6,876 | ) | $ | (12,710 | ) | $ | (12,222 | ) | ||||
Loss per share, basic and diluted |
$ | (0.02 | ) | $ | (0.03 | ) | $ | (0.05 | ) | $ | (0.05 | ) | ||||
Weighted average number of common
shares outstanding, basic and diluted |
285,135,830 | 255,252,433 | 273,155,609 | 254,854,652 |
The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
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OPKO Health, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
(unaudited)
(in thousands)
For the six months ended | ||||||||
June 30, | ||||||||
2011 | 2010 | |||||||
Cash flows from operating activities |
||||||||
Net loss |
$ | (11,450 | ) | $ | (10,899 | ) | ||
Adjustments to reconcile net loss to net cash used in
operating activities: |
||||||||
Depreciation and amortization |
2,082 | 1,964 | ||||||
Accretion of debt discount related to notes payable |
2 | 136 | ||||||
Equity-based compensation employees and non-employees |
3,498 | 2,742 | ||||||
Loss from investments in investees |
874 | 475 | ||||||
Provision for bad debt |
155 | 119 | ||||||
Provision for (reversal of) inventory reserves |
356 | (3 | ) | |||||
Changes in: |
||||||||
Accounts receivable |
(2,074 | ) | (2,610 | ) | ||||
Inventory |
3,217 | (1,170 | ) | |||||
Prepaid expenses and other current assets |
(93 | ) | (516 | ) | ||||
Other assets |
18 | 105 | ||||||
Accounts payable |
(4,248 | ) | 1,331 | |||||
Accrued expenses |
(903 | ) | (2,960 | ) | ||||
Net cash used in operating activities |
(8,566 | ) | (11,286 | ) | ||||
Cash flows from investing activities |
||||||||
Acquisition of businesses, net of cash |
(10,538 | ) | (1,447 | ) | ||||
Purchase of marketable securities |
(69,981 | ) | (14,997 | ) | ||||
Maturities of short-term marketable securities |
14,982 | 5,000 | ||||||
Capital expenditures |
(542 | ) | (510 | ) | ||||
Net cash used in investing activities |
(66,079 | ) | (11,954 | ) | ||||
Cash flows from financing activities: |
||||||||
Issuance of common stock, including related parties, net |
104,828 | | ||||||
Purchase of common stock held in treasury |
(7,832 | ) | | |||||
Redemption of Series A Preferred Stock |
(1,792 | ) | | |||||
Repayment of line of credit with related party |
| (12,000 | ) | |||||
Borrowings under lines of credit |
5,752 | 3,500 | ||||||
Repayments under lines of credit |
(5,845 | ) | (1,271 | ) | ||||
Proceeds from the exercise of stock options and warrants |
308 | 26 | ||||||
Net cash
provided by (used in) financing activities |
95,419 | (9,745 | ) | |||||
Effect of exchange rate changes on cash and cash equivalents |
59 | 13 | ||||||
Net increase (decrease) in cash and cash equivalents |
20,833 | (32,972 | ) | |||||
Cash and cash equivalents at beginning of period |
18,016 | 42,658 | ||||||
Cash and cash equivalents at end of period |
$ | 38,849 | $ | 9,686 | ||||
SUPPLEMENTAL INFORMATION |
||||||||
Interest paid |
$ | 319 | $ | 4,241 | ||||
Income taxes
paid, net |
$ | 347 | $ | 68 | ||||
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.
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OPKO Health, Inc. and Subsidiaries
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
NOTE 1 BUSINESS AND ORGANIZATION
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 and six months ended June 30, 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 interim 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
shareholders 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 and six months ended June 30, 2011
includes net loss for the three and six months and the cumulative
translation adjustment, net,
of $0.7 million and $0.2 million, respectively, for
the translation results of our subsidiaries in Chile and Mexico. Comprehensive loss for the three
and six months ended June 30, 2010 includes net loss for the three and six months and the
cumulative translation adjustment, net, of $1.1 million and $1.4
million respectively, for the translation results of our subsidiaries in Chile
and Mexico.
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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.
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 June 30,
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 June 30, 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.
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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 at June 30, 2011 and December 31, 2010, was $1.1 million and $1.2
million, respectively.
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 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
June 30, 2011 and 2010, we recorded $1.7 million and $1.5 million, respectively, of equity-based
compensation expense. For the six month periods ending June 30, 2011 and 2010, we recorded $3.5
million, and $2.7 million, respectively, of equity-based compensation expense.
Recent accounting pronouncements. In June 2011, the Financial Accounting Standards Board, or
FASB, issued an amendment to the accounting guidance for presentation of comprehensive income.
Under the amended guidance, a company may present the total of comprehensive income, the components
of net income, and the components of other comprehensive income either in a single continuous
statement of comprehensive income or in two separate but consecutive statements. In either case, a
company is required to present each component of net income along with total net income, each
component of other comprehensive income along with a total for other comprehensive income, and a
total amount for comprehensive income. Regardless of choice in presentation, the company is
required to present on the face of the financial statements reclassification adjustments for items
that are reclassified from other comprehensive income to net income in the statement(s) where the
components of net income and the components of other comprehensive income are presented. For public
companies, the amendment is effective for fiscal years, and interim periods within those years,
beginning after December 15, 2011, and shall be applied retrospectively. Early adoption is
permitted. Other than a change in presentation, the adoption of this update is not expected to have
a material impact on our consolidated financial statements.
In May 2011, the FASB amended the accounting guidance for fair value to develop common
requirements between GAAP and International Financial Reporting Standards. The amendments clarify
the FASBs intent about the application of existing fair value measurement and disclosure
requirements and in some instances change a particular principle or requirement for measuring fair
value or for disclosing information about fair value measurements. Notable changes under the
amended guidance include: (i) application of the highest and best use and valuation premise
concepts solely for non-financial assets and liabilities; (ii) measuring the fair value of an
instrument classified in a reporting entitys shareholders equity; and (iii) disclosing
quantitative information about unobservable inputs used in the fair value measurement within Level
3 of the fair value hierarchy. For public entities, the amendment is effective for interim and
annual periods beginning after December 15, 2011. Early application is not permitted. We are
currently evaluating the disclosure requirements related to providing quantitative information
about unobservable inputs used to measure the fair value of its contingent consideration liability.
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
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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.
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 27,356,622 and 20,164,446 potential common shares have been excluded from the
calculation of net loss per share for the three months ended June 30, 2011 and 2010, respectively,
because their inclusion would be anti-dilutive. A total of 27,931,519 and 19,617,796 potential
common shares have been excluded from the calculation of net loss per share for the six months
ended June 30, 2011 and 2010, respectively, because their inclusion would be anti-dilutive. As of
June 30, 2011 the holders of our Series D preferred stock could convert their preferred shares into
approximately 13,795,694 shares of our Common Stock, respectively.
During the six months ended June 30, 2011, approximately 3,194,352 common stock warrants and
common stock options to purchase shares of our common stock were exercised, resulting in the
issuance of 2,841,912 shares of our Common Stock. Of the 3,194,352 common stock warrants and
common stock options exercised, 352,440 shares were surrendered in lieu of a cash payment via the
net exercise feature of the warrant agreements.
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NOTE 4 COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS
(in thousands) | June 30, 2011 | December 31, 2010 | ||||||
Accounts receivable, net: |
||||||||
Accounts receivable |
$ | 16,642 | $ | 14,482 | ||||
Less allowance for doubtful accounts |
(1,114 | ) | (1,165 | ) | ||||
$ | 15,528 | $ | 13,317 | |||||
Inventories, net: |
||||||||
Raw materials (components) |
$ | 4,761 | $ | 4,868 | ||||
Work-in process |
1,305 | 889 | ||||||
Finished products |
10,894 | 14,632 | ||||||
Less inventory reserve |
(634 | ) | (432 | ) | ||||
$ | 16,326 | $ | 19,957 | |||||
Intangible assets, net: |
||||||||
Customer relationships |
$ | 7,615 | $ | 7,719 | ||||
Technology |
14,597 | 4,597 | ||||||
Product registrations |
4,332 | 4,227 | ||||||
Tradename |
672 | 666 | ||||||
Covenants not to compete |
388 | 349 | ||||||
Other |
257 | 7 | ||||||
Less accumulated amortization |
(9,316 | ) | (7,601 | ) | ||||
$ | 18,545 | $ | 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 June 30, 2011 and December 31, 2010. The
increase in Technology and Other reflects the acquisition of CURNA, Inc. Refer to Note 5.
NOTE 5 ACQUISITION AND INVESTMENTS
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. 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 | ||
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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
June 30, 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 June 30, 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 26% of Sorrentos total outstanding
common stock at June 30, 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 June 30, 2011.
Refer to Note 8.
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 June 2011, TESARO completed an equity financing and as such, is no longer a
variable interest entity as they have sufficient resources to carry out their principal activities
without additional subordinated financial support.
In accounting for the TESARO License, 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.
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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 in two entities, 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 June 30, 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 June 30, 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. Dr.s 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.
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 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 | Cost method | ||||
Less accumulated losses in investees |
(1,941 | ) | ||||
Total |
$ | 4,240 | ||||
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
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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 June 30, 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
June 30, 2011, we held money market funds and treasury securities totaling $55.0 million, including
treasury securities maturing July 14, 2011, July 21, 2011 and October 13, 2011, that are required
to be measured at fair value on a recurring basis. The $55.0 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.
Our financial assets and liabilities measured at fair value on a recurring basis are as
follows:
Fair value measurements as of June 30, 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 |
$ | 21,789 | $ | | $ | | $ | 21,789 | ||||||||
Treasury securities |
54,998 | | | 54,998 | ||||||||||||
Total assets |
$ | 76,787 | $ | | $ | | $ | 76,787 | ||||||||
Liabilities: |
||||||||||||||||
Forward contracts |
$ | | $ | 44 | $ | | $ | 44 | ||||||||
CURNA contingent
considerations |
| | 580 | 580 | ||||||||||||
Total liabilities |
$ | | $ | 44 | $ | 580 | $ | 624 | ||||||||
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 June 30, 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.
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The outstanding contracts at June 30, 2011, have been recorded at fair value, and their
maturity details are as follows:
(in thousands) | Fair value at | Unrealized gain | ||||||||||
Days until maturity | Contract value | June 30, 2011 | (loss) | |||||||||
0 to 30 |
$ | 325 | $ | 332 | $ | 7 | ||||||
31 to 60 |
1,694 | 1,717 | 23 | |||||||||
61 to 90 |
| | | |||||||||
91 to 120 |
250 | 264 | 14 | |||||||||
121 to 180 |
| | | |||||||||
More than 180 |
| | | |||||||||
Total |
$ | 2,269 | $ | 2,313 | $ | 44 | ||||||
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 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 an unutilized $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. 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. In June 2011, the Company entered into a letter agreement with TSRI pursuant to
which it licensed approximately 120 square feet of additional space for three months on
substantially the same terms as the use agreement.
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.
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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.
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 Drs. Frost and 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 December 31,
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 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.
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 and six months
ended June 30, 2011, we reimbursed Dr. Frost approximately $56 thousand and $113 thousand,
respectively, for Company-related travel by Dr. Frost and other OPKO executives. For the three and
six months ended June 30,
2010, we reimbursed Dr. Frost approximately $7 thousand and $25 thousand, respectively, for
Company-related travel by Dr. Frost and other OPKO executives.
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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 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.
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Information regarding our operations and assets for the two segments and the unallocated
corporate operations as well as geographic information are as follows:
For the three months ended | For the six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
(in thousands) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Product revenue |
||||||||||||||||
Pharmaceutical |
$ | 8,416 | $ | 5,273 | $ | 15,353 | $ | 10,585 | ||||||||
Instrumentation |
1,714 | 2,182 | 3,412 | 4,792 | ||||||||||||
$ | 10,130 | $ | 7,455 | $ | 18,765 | $ | 15,377 | |||||||||
Operating loss |
||||||||||||||||
Pharmaceutical |
$ | (2,323 | ) | $ | (1,415 | ) | $ | (3,342 | ) | $ | (2,059 | ) | ||||
Instrumentation |
(381 | ) | (998 | ) | (1,336 | ) | (1,934 | ) | ||||||||
Corporate |
(2,458 | ) | (3,114 | ) | (5,570 | ) | (5,600 | ) | ||||||||
$ | (5,162 | ) | $ | (5,527 | ) | $ | (10,248 | ) | $ | (9,593 | ) | |||||
Depreciation and amortization |
||||||||||||||||
Pharmaceutical |
$ | 895 | $ | 529 | $ | 1,719 | $ | 1,043 | ||||||||
Instrumentation |
149 | 444 | 279 | 888 | ||||||||||||
Corporate |
41 | 20 | 84 | 33 | ||||||||||||
$ | 1,085 | $ | 993 | $ | 2,082 | $ | 1,964 | |||||||||
Revenue |
||||||||||||||||
United States |
$ | 196 | $ | 172 | $ | 460 | $ | 369 | ||||||||
Chile |
6,463 | 4,257 | 12,219 | 9,194 | ||||||||||||
Mexico |
2,017 | 1,138 | 3,216 | 1,391 | ||||||||||||
All others |
1,454 | 1,888 | 2,870 | 4,423 | ||||||||||||
$ | 10,130 | $ | 7,455 | $ | 18,765 | $ | 15,377 | |||||||||
As of | ||||||||
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Assets |
||||||||
Pharmaceutical |
$ | 54,352 | $ | 51,599 | ||||
Instrumentation |
9,271 | 8,637 | ||||||
Corporate |
96,796 | 17,610 | ||||||
$ | 160,419 | $ | 77,846 | |||||
During the three months ended June 30, 2011, our largest customer represented approximately
16% of our total revenue. As of June 30, 2010, our two largest customers
represented approximately 15% and 13%, respectively, of our accounts receivable balance. During
the six months ended June 30, 2011, our largest customer
represented approximately 19% of our total
revenue. As of June 30, 2010, our two largest customers represented
approximately 15% and 13%, respectively, of our accounts receivable balance. As of June 30, 2011,
our largest customer represented approximately 28% of our accounts receivable balance. As of
December 31, 2010, two customers represented 32% and 11%, respectively, of our accounts receivable
balance.
NOTE 11 COMMON STOCK ISSUANCE, REPURCHASE AND SERIES A PREFERRED STOCK REDEMPTION
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.
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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 | ||||||
(1) | The underwriters did 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. |
On
June 20, 2011, we repurchased 2,398,740 shares of our Common Stock for an aggregate purchase
price of $7.8 million through a privately negotiated transaction with an early investor in Acuity
Pharmaceuticals, Inc., a predecessor company of ours.
On June 3, 2011, we redeemed all outstanding shares of our Series A Preferred Stock for an
aggregate redemption price of $1.8 million, including accrued dividends.
NOTE 12 SUBSEQUENT EVENTS
We have reviewed all subsequent events and transactions that occurred after the date of our
June 30, 2011 consolidated balance sheet date, through the time of filing this Quarterly Report on
Form 10-Q.
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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 in the
future 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 JUNE 30, 2011 AND 2010
Revenue. Revenue for the three months ended June 30, 2011, was $10.1 million, compared to
$7.5 million for the comparable 2010 period. The increase in revenue during the three months ended
June 30, 2011 is primarily due to revenue from our OPKO Chile and Exakta-OPKO pharmaceutical
businesses as we expand the customer mix at those businesses. Revenue from our instrumentation
business decreased from the 2010 period primarily as a result of decreased sales of our OCT/SLO
product in international markets.
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Gross margin. Gross margin for the three months ended June 30, 2011, was $3.9 million
compared to $2.6 million for the comparable period of 2010. Gross margin for the three months
ended June 30, 2011, increased 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 June 30, 2011, was $4.9 million compared to $5.6 million of expense for the
comparable period of 2010. The decrease in selling, general and administrative expenses is
primarily the result of decreased equity based compensation. Selling, general and administrative
expenses during the three months ended June 30, 2011 and 2010 primarily include personnel expenses,
including equity-based compensation expense of $0.3 million and
$1.2 million, respectively, and
professional fees.
Research and development expense. Research and development expense during the three months
ended June 30, 2011 and 2010, was $3.2 million and $1.6 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 June 30, 2011 and 2010, include
equity-based compensation expense of $1.4 million and $0.3 million, respectively. The increase in
research and development expense during the three months ended June 30, 2011, was primarily the
result of increased activities related to our molecular diagnostics development program and
development of the technology acquired from CURNA.
Other operating expenses. Other operating expenses were $1.0 million and $0.9 million,
respectively, for the three months ended June 30, 2011 and June 30, 2010. Other operating expenses
primarily include the amortization of intangible assets. Amortization expense during the three
months ended June 30, 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 expense was $0.1 million for the three months ended June 30,
2011 compared to $0.4 million for the comparable 2010 period. Other income and expense primarily
consists of interest earned on our cash and cash equivalents, offset by foreign currency expense.
Other expense during the 2010 period 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.
FOR THE SIX MONTHS ENDED JUNE 30, 2011 AND 2010
Revenue. Revenue for the six months ended June 30, 2011, was $18.8 million, compared to $15.4
million for the comparable 2010 period. The increase in revenue during the first six months of 2011
is primarily due to revenue from our OPKO Chile and Exakta-OPKO
pharmaceutical businesses in Chile and Mexico. We
acquired Exakta-OPKO in February 2010, and as a result, the 2010 period reflects revenue only after
the acquisition occurred. Revenue from our instrumentation business decreased from the 2010 period
primarily as a result of decreased sales of our OCT/SLO product in international markets
Gross margin. Gross margin for the six months ended June 30, 2011, was $7.0 million compared
to $5.0 million for the comparable period of 2010. Gross margin for the six months ended June 30,
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 six months ended June 30, 2011, was $10.5 million compared to $9.9 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
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expenses during the first six months of 2011 and 2010 primarily include personnel expenses,
including equity-based compensation expense of $1.7 million and
$2.2 million, respectively, and
professional fees.
Research and development expense. Research and development expense during the six months ended
June 30, 2011 and 2010, was $4.8 million and $2.9 million, respectively. The increase in research
and development expense primarily is the result of increased personnel expenses including equity
based compensation expense. The six months ended June 30, 2011 and 2010, include equity-based
compensation expense of $1.8 million and $0.5 million, respectively. During the six months ended
June 30, 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 six month period ended June 30, 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 $1.9 million for the six months ended
June 30, 2011 compared to $1.8 million for the six months ended June 30, 2010. Other operating
expenses primarily include the amortization of intangible assets. Amortization expense during the
six months ended June 30, 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 $0.1 million for the first six months of 2011
compared to other expense, net of $0.7 million for the comparable 2010 period. Other income and
expenses primarily consists of interest earned on our cash and cash equivalents offset by foreign
currency expense for the 2011 period, compared to the 2010 period
which primarily reflects the interest
incurred on our line of credit with 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.
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 June 30, 2011, we had cash, cash equivalents and marketable securities of approximately
$93.8 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
June 20, 2011, we repurchased 2,398,740 shares of our Common Stock for an aggregate purchase
price of $7.8 million through a privately negotiated transaction with an early investor in Acuity
Pharmaceuticals, Inc., a predecessor company of ours.
On June 3, 2011, we redeemed all outstanding shares of our Series A Preferred Stock for an
aggregate redemption price of $1.8 million, including accrued dividends.
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, 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
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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
$14.6 million with nine financial
institutions in Chile, of which, approximately $3.3 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 8%. 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
June 30, 2011, was $14.7 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. As
of June 30, 2011, there were no amounts outstanding under this line
of credit.
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 June 30, 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 in the future 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 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
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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 June 30, 2011 and December 31, 2010 was $1.1
million and $1.2 million, respectively.
Recent accounting pronouncements: In June 2011, the Financial Accounting Standards Board, or
FASB, issued an amendment to the accounting guidance for presentation of comprehensive income.
Under the amended guidance, a company may present the total of comprehensive income, the components
of net income, and the components of other comprehensive income either in a single continuous
statement of comprehensive income or in two separate but consecutive statements. In either case, a
company is required to present each component of net income along with total net income, each
component of other comprehensive income along with a total for other comprehensive income, and a
total amount for comprehensive income. Regardless of choice in presentation, the company is
required to present on the face of the financial statements reclassification adjustments for items
that are reclassified from other comprehensive income to net income in the statement(s) where the
components of net income and the components of other comprehensive income are presented. For public
companies, the amendment is effective for fiscal years, and interim periods within those years,
beginning after December 15, 2011, and shall be applied retrospectively. Early adoption is
permitted. Other than a change in presentation, the adoption of this update is not expected to have
a material impact on our consolidated financial statements.
In May 2011, the FASB amended the accounting guidance for fair value to develop common
requirements between GAAP and International Financial Reporting Standards. The amendments clarify
the FASBs intent about the application of existing fair value measurement and disclosure
requirements and in some instances change a particular principle or requirement for measuring fair
value or for disclosing information about fair value measurements. Notable changes under the
amended guidance include: (i) application of the highest and best use and valuation premise
concepts solely for non-financial assets and liabilities; (ii) measuring the fair value of an
instrument classified in a reporting entitys shareholders equity; and (iii) disclosing
quantitative information about unobservable inputs used in the fair value measurement within Level
3 of the fair value hierarchy. For public entities, the amendment is effective for interim and
annual periods beginning after December 15, 2011. Early application is not permitted. We are
currently evaluating the disclosure requirements related to providing quantitative information
about unobservable inputs used to measure the fair value of its contingent consideration liability.
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In December 2010, the Financial Accounting Standards Board, or 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.
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 we do not enter into any leveraged derivative
transactions. We had $2.3 million in foreign exchange forward contracts outstanding at June 30,
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.
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.
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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 June 30, 2011, we had
cash, cash equivalents and marketable securities of $93.8 million. The weighted average interest
rate related to our cash and cash equivalents for the three months ended June 30, 2011 was 0%. As
of June 30, 2011, the principal value of our credit lines was $14.6 million, and have a weighted
average interest rate of approximately 6% for the six months then ended.
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 three months.
Item 4. Controls and Procedures
Disclosure 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
June 30, 2011. Based on that evaluation, the 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.
Changes to the Companys Internal Control Over Financial Reporting
There have been no changes to the Companys internal control over financial reporting that
occurred during the Companys second 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 for the year ended December 31, 2010.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On
June 20, 2011, we repurchased 2,398,740 shares of our Common Stock for an aggregate purchase
price of $7.8 million through a privately negotiated transaction with an early investor in Acuity
Pharmaceuticals, Inc., a predecessor company of ours.
Issuer Purchases of Equity Securities:
(c) | (d) | |||||||||||||||
(a) | (b) | Total number of shares | Maximum number of shares that | |||||||||||||
Total number of | Average price | purchased as part of publicly | may yet be purchased under the | |||||||||||||
Period | shares purchased | paid per share | announced plans or programs | plans or programs | ||||||||||||
April 1-30, 2011 |
0 | $ | 0 | 0 | 0 | |||||||||||
May 1-31, 2011 |
0 | $ | 0 | 0 | 0 | |||||||||||
June 1-30, 2011 |
2,398,740 | $ | 3.27 | 0 | 0 | |||||||||||
Total |
2,398,740 | $ | 3.27 | 0 | 0 |
Item 3. Defaults Upon Senior Securities
None.
Item 4. (Removed and Reserved)
Item 5. Other Information
None.
Item 6. Exhibits.
Exhibit 1.1(6)
|
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. | |
Exhibit 2.1(1)
|
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. | |
Exhibit 2.2(4)+
|
Securities Purchase Agreement dated May 2, 2008, among Vidus Ocular, Inc., OPKO Instrumentation, LLC, OPKO Health, Inc., and the individual sellers and noteholders named therein. | |
Exhibit 2.3(5)
|
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. | |
Exhibit 2.4(7+)
|
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 3.1(2)
|
Amended and Restated Certificate of Incorporation. | |
Exhibit 3.2(3)
|
Amended and Restated By-Laws. | |
Exhibit 4.1(1)
|
Form of Common Stock Warrant. | |
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 June 30, 2011. |
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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 June 30, 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 June 30, 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 June 30, 2011. | |
Exhibit 101*
|
The following materials from the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, formatted in XBRL (Extensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Operations, (iii) Condensed Consolidated Statements of Cash Flows, and (iv) Notes to Financial Statements, tagged as blocks of text. |
+ | Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission. | |
* | As provided in Rule 406T of Regulation S-T, this information is furnished herewith and not filed for purposes of sections 11 and 12 of the Securities Act of 1933, as amended, or section 18 of the Securities Exchange Act of 1934, as amended. | |
(1) | 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. | |
(2) | 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. | |
(3) | 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. | |
(4) | 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. | |
(5) | 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. | |
(6) | 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. | |
(7) | Filed with the Companys Quarterly Report on Form 10-Q/A filed with the Securities and Exchange Commission on July 5, 2011 for the Companys three-month period ended March 31, 2011, and incorporated herein by reference. |
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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:
August 8, 2011
|
OPKO Health, Inc. | |||
/s/ Adam Logal
|
||||
Executive Director of Finance, Chief Accounting | ||||
Officer and Treasurer |
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Exhibit Index
Exhibit Number | Description | |
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 June 30, 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 June 30, 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 June 30, 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 June 30, 2011. | |
Exhibit 101*
|
The following materials from the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, formatted in XBRL (Extensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Operations, (iii) Condensed Consolidated Statements of Cash Flows, and (iv) Notes to Financial Statements, tagged as blocks of text. |
* | As provided in Rule 406T of Regulation S-T, this information is furnished herewith and not filed for purposes of sections 11 and 12 of the Securities Act of 1933, as amended, or section 18 of the Securities Exchange Act of 1934, as amended. |
32