Document and Entity Information(USD $)
9 Months Ended
Sep. 30, 2011
Nov. 1, 2011
Jun. 30, 2010
Document and Entity Information [Abstract]
Entity Registrant Name
Opko Health, Inc.
Entity Central Index Key
0000944809
Document Type
10-Q
Document Period End Date
Sep. 30, 2011
Amendment Flag
FALSE
Document Fiscal Year Focus
2011
Document Fiscal Period Focus
Q3
Current Fiscal Year End Date
--12-31
Entity Well-known Seasoned Issuer
No
Entity Voluntary Filers
No
Entity Current Reporting Status
Yes
Entity Filer Category
Accelerated Filer
Entity Public Float
$253,812,039
Entity Common Stock, Shares Outstanding
290,272,310
Condensed Consolidated Balance Sheets (Unaudited)(USD $)
In Thousands
Sep. 30, 2011
Dec. 31, 2010
Current assets
Cash and cash equivalents
$47,235
$18,016
Marketable securities
40,182
0
Accounts receivable, net
12,688
11,856
Inventory, net
10,516
16,423
Prepaid expenses and other current assets
1,729
2,679
Current assets of discontinued operations
5,279
5,098
Total current assets
117,629
54,072
Property and equipment, net
3,271
2,589
Intangible assets, net
14,252
6,784
Goodwill
6,234
5,856
Investments
5,862
5,114
Other assets
824
111
Assets of discontinued operations
2,929
3,320
Total assets
151,001
77,846
Current liabilities
Accounts payable
2,556
6,479
Accrued expenses
3,678
3,370
Current portion of lines of credit
12,547
14,690
Current liabilities of discontinued operations
1,460
3,060
Total current liabilities
20,241
27,599
Long-term liabilities
2,154
1,067
Total liabilities
22,395
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 $34,813 and $33,013) at September 30, 2011 and December 31, 2010, respectively
26,128
26,128
Shareholders' equity
Common Stock - $0.01 par value, 500,000,000 shares authorized; 288,141,824 and 255,412,706 shares issued at September 30, 2011 and December 31, 2010, respectively
2,881
2,554
Treasury stock - 2,443,894 and 45,154 shares at September 30, 2011 and December 31, 2010, respectively
(7,893)
(61)
Additional paid-in capital
485,181
376,008
Accumulated other comprehensive income
434
2,921
Accumulated deficit
(378,125)
(358,379)
Total shareholders' equity
102,478
23,052
Total liabilities, Series D Preferred Stock, and Shareholders' equity
151,001
77,846
Series A Preferred stock
Shareholders' equity
Preferred stock
0
9
Series C Preferred stock
Shareholders' equity
Preferred stock
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical)(USD $)
In Thousands, except Share data
Sep. 30, 2011
Dec. 31, 2010
Current liabilities
Temporary equity, par value
$0.01
$0.01
Temporary equity, shares authorized
2,000,000
2,000,000
Temporary equity, shares issued
1,209,677
1,209,677
Temporary equity, shares outstanding
1,209,677
1,209,677
Liquidation preference, preferred stock value
$34,813
$33,013
Shareholders' equity
Common stock, par value
$0.01
$0.01
Common stock, shares authorized
500,000,000
500,000,000
Common stock, shares issued
288,141,824
255,412,706
Treasury stock, shares
2,443,894
45,154
Series A Preferred stock
Current liabilities
Liquidation preference, preferred stock value
$0
$2,468
Shareholders' equity
Preferred stock, par value
$0.01
$0.01
Preferred stock, shares authorized
4,000,000
4,000,000
Preferred stock, shares issued
0
897,439
Preferred stock, shares outstanding
0
897,439
Series C Preferred stock
Shareholders' equity
Preferred stock, par value
$0.01
$0.01
Preferred stock, shares authorized
500,000
500,000
Preferred stock, shares issued
Preferred stock, shares outstanding
Condensed Consolidated Statements of Operations (Unaudited)(USD $)
In Thousands, except Share data
3 Months Ended
Sep.30,
9 Months Ended
Sep.30,
2011
2010
2011
2010
Revenue
Product sales
$6,760
$5,678
$22,113
$16,262
Other revenue
47
72
Total Revenue
6,807
5,678
22,185
16,262
Cost of goods sold, excluding amortization of intangible assets
4,017
3,348
13,085
10,145
Gross margin, excluding amortization of intangible assets
2,790
2,330
9,100
6,117
Operating expenses
Selling, general and administrative
4,348
4,440
14,102
12,802
Research and development
3,301
1,543
7,097
3,634
Other operating expenses, principally amortization of intangible assets
945
568
2,615
1,558
Total operating expenses
8,594
6,551
23,814
17,994
Operating loss from continuing operations
(5,804)
(4,221)
(14,714)
(11,877)
Other expense, net
(671)
(320)
(757)
(1,047)
Loss from continuing operations before income taxes and investment loss
(6,475)
(4,541)
(15,471)
(12,924)
Income tax (benefit) provision
(27)
83
199
184
Loss from continuing operations before investment losses
(6,448)
(4,624)
(15,670)
(13,108)
Loss from investments in investees
(301)
(208)
(1,175)
(683)
Loss from continuing operations
(6,749)
(4,832)
(16,845)
(13,791)
Loss from discontinued operations, net of tax
(1,487)
(2,522)
(2,841)
(4,462)
Net loss
(8,236)
(7,354)
(19,686)
(18,253)
Preferred stock dividend
(600)
(656)
(1,860)
(1,979)
Net loss attributable to common Shareholders
$(8,836)
$(8,010)
$(21,546)
$(20,232)
Loss per share, basic and diluted
Loss per share from continuing operations
$(0.02)
$(0.02)
$(0.06)
$(0.05)
Loss per share
$(0.03)
$(0.03)
$(0.08)
$(0.08)
Weighted average number of common shares outstanding, basic and diluted
285,582,259
255,252,433
277,359,789
254,854,652
Condensed Consolidated Statements of Cash Flows (Unaudited)(USD $)
In Thousands
9 Months Ended
Sep.30,
2011
2010
Cash flows from operating activities
Loss from continuing operations
$(16,845)
$(13,791)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
2,858
1,712
Accretion of debt discount related to notes payable
2
248
Equity-based compensation - employees and non-employees
5,350
3,808
Loss from investments in investees
1,175
683
Provision for (recovery of) bad debt
260
(8)
Provision for inventory reserves
534
25
Changes in:
Accounts receivable
(2,523)
(2,847)
Inventory
4,080
(3,555)
Prepaid expenses and other current assets
224
(263)
Other assets
53
18
Accounts payable
(3,652)
1,372
Accrued expenses
852
(3,731)
Cash used in operating activities from continuing operations
(7,632)
(16,329)
Cash used in operating activities from discontinuing operations
(4,280)
(927)
Net cash used in operating activities
(11,912)
(17,256)
Cash flows from investing activities
Acquisition of businesses, net of cash
(10,538)
(1,323)
Investment in Neovasc
(2,013)
Purchase of marketable securities
(100,161)
(14,997)
Maturities of short-term marketable securities
59,982
14,997
Capital expenditures
(1,249)
(601)
Cash used in investing activities from continuing operations
(53,979)
(1,924)
Cash used in investing activities from discontinued operations
(29)
Net cash used in investing activities
(53,979)
(1,953)
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
10,056
5,476
Repayments under lines of credit
(10,761)
(1,874)
Proceeds from the exercise of stock options and warrants
774
26
Net cash provided by (used in) financing activities
95,273
(8,372)
Effect of exchange rate changes on cash and cash equivalents
(163)
100
Net increase (decrease) in cash and cash equivalents
29,219
(27,481)
Cash and cash equivalents at beginning of period
18,016
42,658
Cash and cash equivalents at end of period
47,235
15,177
SUPPLEMENTAL INFORMATION
Interest paid
608
4,266
Income taxes paid, net
355
(160)
Issuance of capital stock to acquire Exakta-OPKO
$1,999
Business and Organization
BUSINESS AND ORGANIZATION

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. We are developing a range of solutions to diagnose, treat and prevent various 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.

Summary of Significant Accounting Policies
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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 Company’s results of operations, financial position and cash flows have been made. The results of operations and cash flows for the three and nine months ended September 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 nine months ended September 30, 2011 includes net loss for the three and nine months, the unrealized loss of $0.2 million and $0.2 million, respectively, on our common stock options and warrants of Neovasc, Inc. (Refer to Note 5) and the cumulative translation adjustment, net, of $2.5 million and $2.3 million, respectively, for the translation results of our subsidiaries in Chile and Mexico. Comprehensive loss for the three and nine months ended September 30, 2010 includes net loss for the three and nine months and the cumulative translation adjustment, net, of $2.3 million and $0.8 million, respectively, for the translation results of our subsidiaries in Chile and Mexico.

 

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. Refer to Note 6.

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. In addition, other revenue includes revenue related to our consulting agreement we entered into with Neovasc, Inc. (Refer to Note 5). We recognize the revenue on a straight-line basis over the contractual term of the agreement.

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 vendor’s 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 $1.0 million and $0.2 million at September 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 September 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 our results from operations. Refer to Note 8.

 

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 for continuing operations at September 30, 2011 and December 31, 2010, was $0.3 million and $0.3 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 reviews our operating results and operating plans and makes resource allocation decisions on a company-wide or aggregate basis. Accordingly, we have aggregated our two operating segments, pharmaceutical operating business and pharmaceutical research and development activities into one reporting segment, pharmaceutical as we expect the businesses to have similar long-term economic characteristics. All of the results from our instrumentation business have been reclassified as discontinued operations. Refer to Note 6.

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 September 30, 2011 and 2010, we recorded $1.8 million and $1.3 million, respectively, of equity-based compensation expense for continuing operations. For the nine month periods ending September 30, 2011 and 2010, we recorded $5.3 million, and $3.8 million, respectively, of equity-based compensation expense for continuing operations.

Recent accounting pronouncements. In May 2011, the Financial Accounting Standards Board (“FASB”) issued amended accounting guidance related to fair value measurements and disclosures with the purpose of converging the fair value measurement and disclosure guidance issued by the FASB and the International Accounting Standards Board. The guidance is effective for reporting periods beginning after December 15, 2011. The guidance includes amendments that clarify the intent of the application of existing fair value measurement requirements along with amendments that change a particular principle or requirement for fair value measurements and disclosures. We concluded that the new guidance will not have a material impact on our Condensed Consolidated Statements of Operations, Condensed Consolidated Balance Sheet, or related disclosures.

In June 2011, the FASB issued amended accounting guidance related to presentation of comprehensive income. The standards update is intended to help financial statement users better understand the causes of an entity’s change in financial position and results of operation. It is effective for reporting periods beginning after December 15, 2011. The amendments eliminate the option to present components of other comprehensive income as part of the statement of changes in stockholders’ equity. The amendments require that all non-owner changes in stockholders’ equity be presented either in a single continuous statement of comprehensive income or in two separate but consecutive statements. The guidance also requires that reclassification adjustments for items that are reclassified from other comprehensive income to net income be presented on the face of the financial statement where the components of net income and other comprehensive income are presented. Upon adoption, we will continue to present components of comprehensive income in our Consolidated Statements of Operations. These statements will include reclassification adjustments as required by the new guidance for all periods presented. Since this new guidance will affect disclosure requirements only, we have concluded that it will not have a material impact on our financial position or results of operations.

In September 2011, the FASB issued ASU to amend the guidance in the ASC related to Intangibles – Goodwill and Other. This amendment will provide us the option of performing a qualitative assessment before calculating the fair value of the reporting unit. If it is determined that the fair value of the reporting unit is more likely than not less than the carrying amount, on the basis of qualitative factors, the two-step impairment test would be required. The amendment is effective for annual and interim goodwill impairment tests performed for our 2012 fiscal year, with earlier adoption permitted. This ASU impacts the manner in which goodwill is assessed for impairment but does not change how goodwill is calculated or assigned to reporting units, nor does it revise the requirement to test goodwill annually for impairment. It also does not change the requirement to test goodwill for impairment between annual tests if there are indicators of impairment. This ASU has no effect on our financial condition, results of operations or cash flows.

Loss Per Share
LOSS PER SHARE

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 26,263,152 and 20,968,353 potential common shares have been excluded from the calculation of net loss per share for the three months ended September 30, 2011 and 2010, respectively, because their inclusion would be anti-dilutive. A total of 27,375,394 and 20,067,981 potential common shares have been excluded from the calculation of net loss per share for the nine months ended September 30, 2011 and 2010, respectively, because their inclusion would be anti-dilutive. As of September 30, 2011 the holders of our Series D preferred stock could convert their preferred shares into approximately 14,037,630 shares of our Common Stock, respectively.

During the nine months ended September 30, 2011, approximately 3,389,852 common stock warrants and common stock options to purchase shares of our common stock were exercised, resulting in the issuance of 3,037,412 shares of our Common Stock. Of the 3,389,852 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.

 

Composition of Certain Financial Statement Captions
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS

NOTE 4 COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS

 

                 

(in thousands)

  September 30,
2011
    December 31,
2010
 

Accounts receivable, net:

               

Accounts receivable

  $ 13,017     $ 12,135  

Less allowance for doubtful accounts

    (329     (279
   

 

 

   

 

 

 
    $ 12,688     $ 11,856  
   

 

 

   

 

 

 
     

Inventories, net:

               

Raw materials

  $ 2,354     $ 2,638  

Work-in process

    327       408  

Finished products

    8,339       13,642  

Less inventory reserve

    (504     (265
   

 

 

   

 

 

 
    $ 10,516     $ 16,423  
   

 

 

   

 

 

 
     

Intangible assets, net:

               

Customer relationships

  $ 4,161     $ 4,741  

Technology

    10,000       —    

Product registrations

    3,883       4,227  

Tradename

    427       471  

Covenants not to compete

    62       32  

Other

    257       7  

Less accumulated amortization

    (4,538     (2,694
   

 

 

   

 

 

 
    $ 14,252     $ 6,784  
   

 

 

   

 

 

 

The change in value of the intangible assets include the foreign currency fluctuation between the Chilean and Mexican pesos against the US dollar at September 30, 2011 and December 31, 2010. The increase in Technology and Other reflects the acquisition of CURNA, Inc. Refer to Note 5.

Acquisitions and Investments
ACQUISITIONS AND INVESTMENTS

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  
   

 

 

 

 

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 August 2011, we made an investment in Neovasc Inc. (“Neovasc”) a medical technology company based in Vancouver, Canada, a Canadian publicly traded company. Neovasc is developing devices to treat cardiovascular diseases and is also a leading supplier of tissue components for the manufacturers of replacement heart valves. We invested $2.0 million and received two million Neovasc common shares, and two-year warrants to purchase an additional one million shares for $1.25 a share. We recorded the warrants at their estimated fair value using the Black-Scholes-Merton Model at $0.7 million. We recorded an unrealized loss of $0.1 million at September 30, 2011 related to these warrants to reflect the closing price decrease of Neovasc common stock. We also entered into an agreement with Neovasc to provide strategic advisory services to Neovasc as it continues to develop and commercialize its novel cardiac devices. In connection with the consulting agreement, Neovasc granted us 913,750 common stock options. The options were granted at (Canadian) $1.00 per share and vest annually over three years. We valued the options using the Black-Scholes-Merton Model at $0.8 million on the date of grant and will recognize the revenue over four years as other revenue. In addition, we recorded an unrecognized loss of $0.1 million at September 30, 2011 related to these options to reflect the (Canadian) $0.91 closing share price of Neovasc. Refer to Note 9.

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 September 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 9.

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 September 30, 2011 we hold approximately 16% of Cocrystal on a fully diluted basis. Refer to Note 9.

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 Sorrento’s total outstanding common stock at September 30, 2011. The closing stock price for Sorrento’s common stock, a thinly traded stock, as quoted on the over-the-counter markets was $0.23 per share on September 30, 2011. Refer to Note 9.

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 it has sufficient resources to carry out its 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.

Pursuant to an asset purchase agreement with Schering-Plough Corporation (“Schering”), we acquired rolapitant and other assets relating to Schering’s 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 September 30, 2011 we own approximately 16% of Cocrystal and members of the Frost Group own approximately 42% of Cocrystal’s 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. Drs. Frost, Hsiao and Lerner are all members of our Board of Directors. As of September 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. Drs. Frost and Hsiao currently serve on the Board of Managers of Fabrus and represent 40% of its board. The Gamma Trust can significantly influence the success of Fabrus through its board representation and voting power. As such, we have determined that the Gamma Trust is the primary beneficiary within the related party group. Because we have the ability to exercise significant influence over Cocrystal’s 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 (2009)

  $ 2,300    

Equity method

Cocrystal (2009)

    2,500    

VIE, equity method

Fabrus (2010)

    650    

VIE, equity method

TESARO (2010)

    731    

Cost method

NEOVASC (2011)

    2,013    

Equity method, Cost (warrants)

Less accumulated losses in investees

    (2,242    

Unrealized loss

    (90    
   

 

 

     

Total

  $ 5,862      
   

 

 

     
Discontinued Operations
DISCONTINUED OPERATIONS

NOTE 6 DISCONTINUED OPERATIONS

In September 2011, we announced that we entered into an agreement with OPTOS, Inc., a subsidiary of Optos plc (collectively “OPTOS”) to sell our ophthalmic instrumentation business. Upon closing in October 2011, we received $17.5 million of cash and we will receive royalties up to $22.5 million on future sales. We anticipate recording a gain in connection with the sale.

The assets and liabilities related to our instrumentation business have identifiable cash flows that are independent of the cash flows of other groups of assets and liabilities and we will not have a significant continuing involvement with the related products beyond one year after the closing of the transactions. Therefore, the accompanying Condensed Consolidated Balance Sheets report the assets and liabilities related to our instrumentation business as discontinued operations in all periods presented, and the results of operations related to our instrumentation business have been classified as discontinued operations in the accompanying Condensed Consolidated Statements of Operations for all periods presented.

The following table presents the major classes of assets and liabilities that have been presented as assets of discontinued operations and liabilities of discontinued operations in the accompanying Condensed Consolidated Balance Sheets:

 

                 

In thousands

  September 30,
2011
    December 31,
2010
 

Trade accounts receivable, net

  $ 650     $ 1,461  

Inventories, net

    4,427       3,534  

Other current assets

    202       103  
   

 

 

   

 

 

 

Total current assets

    5,279       5,098  

Property, plant and equipment, net

    94       140  

Intangible assets, net

    2,835       3,180  
   

 

 

   

 

 

 

Total assets of discontinued operations

  $ 8,208     $ 8,418  
   

 

 

   

 

 

 

Trade accounts payable

  $ 299     $ 690  

Accrued expenses and other liabilities

    1,161       2,370  
   

 

 

   

 

 

 

Total liabilities of discontinued operations

  $ 1,460     $ 3,060  
   

 

 

   

 

 

 

The following table presents summarized financial information for the discontinued operations presented in the Condensed Consolidated Statements of Operations:

 

                                 

(in thousands, except per share amounts)

  For the three months ended
September 30,
    For the nine months ended
September 30,
 
  2011     2010     2011     2010  

Total revenue

  $ 730     $ 1,922     $ 4,142     $ 6,714  

Operating loss

    (1,481     (2,522     (2,819     (4,460

Loss before provision for income taxes

    (1,487     (2,522     (2,841     (4,462

Net loss

    (1,487     (2,522     (2,841     (4,462

Loss per share from discontinued operations, basic and diluted

  $ (0.00   $ (0.01   $ (0.01   $ (0.02

 

Fair Value Measurements
FAIR VALUE MEASUREMENTS

NOTE 7 FAIR VALUE MEASUREMENTS

We record fair value at an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. We utilize a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

As of September 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 8) 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 September 30, 2011, we held money market funds and treasury securities totaling $55.7 million, including $10.0 million of treasury securities maturing October 13, 2011, that are required to be measured at fair value on a recurring basis. In addition, we held $30.2 million of US Treasury Notes. Both the $10.0 million of treasury securities and the $30.2 million of US Treasury Notes are recorded at amortized cost, which reflects their approximate fair value. The carrying value of our other assets and liabilities approximates their fair value due to their short-term nature. In addition, in connection with our investment in Neovasc as well as entering into our consulting agreement with Neovasc, we record our options and warrants at fair value. Refer to Note 5.

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 September 30, 2011  
(in thousands)   Quoted
prices in
active
markets for
identical
assets

(Level 1)
    Significant
other
observable
inputs

(Level 2)
    Significant
unobservable
inputs

(Level 3)
    Total  

Assets:

                               

Money market funds

  $ 45,709     $ —       $ —       $ 45,709  

Forward contracts

    —         183       —         183  

US Treasury Notes

    —         30,182       —         30,182  

US Treasury securities

    10,000       —         —         10,000  

Neovasc common stock options

            736               736  

Neovasc common stock warrants

            564               564  
   

 

 

   

 

 

   

 

 

   

 

 

 

Total assets

  $ 55,709     $ 31,665     $ —       $ 87,374  
   

 

 

   

 

 

   

 

 

   

 

 

 
         

Liabilities:

                               

CURNA contingent considerations

  $ —       $ —       $ 580     $ 580  
   

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities

  $ —       $ —       $ 580     $ 580  
   

 

 

   

 

 

   

 

 

   

 

 

 
Derivative Contracts
DERIVATIVE CONTRACTS

NOTE 8 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 our results from operations 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 September 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.

The outstanding contracts at September 30, 2011, have been recorded at fair value, and their maturity details are as follows:

 

                         

(in thousands)

Days until maturity

  Contract value     Fair value at
September 30, 2011
    Unrealized gain  

0 to 30

  $ 708     $ 646     $ 62  

31 to 60

    1,060       962       98  

61 to 90

    46       41       5  

91 to 120

    55       50       5  

121 to 180

    147       134       13  

More than 180

    —         —         —    
   

 

 

   

 

 

   

 

 

 

Total

  $ 2,016     $ 1,833     $ 183  
   

 

 

   

 

 

   

 

 

 
Related Party Transactions
RELATED PARTY TRANSACTIONS

NOTE 9 RELATED PARTY TRANSACTIONS

On August 17, 2011, we made an investment in Neovasc Inc. a medical technology company. Refer to Note 5. Dr. Frost and other members of OPKO management are shareholders of Neovasc. Prior to the investment, Dr. Frost beneficially owned approximately 36% of Neovasc, Dr. Jane Hsiao owned approximately 6%, and each of Dr. Uppaluri and Mr. Rubin owned less than 1%. Dr. Jane Hsiao and Steven Rubin also serve on the board of directors for Neovasc.

On March 14, 2011, we issued 27,000,000 shares of our Common Stock. Refer to Note 12. 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 CURNA’s 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.

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 Cocrystal’s 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. Effective as of July 1, 2011, the lease was amended to include an additional 5,000 square feet of space at the same rate per square foot as was then in effect under the lease. Following the amendment, gross rent payable under the lease is $0.2 million per year. Upon the closing of the sale of the Company’s instrumentation business to Optos, the Company assigned the lease to Optos.

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 Company’s 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 Winston’s board. Effective May 19, 2010, the members of the Frost Group sold 100% of Winston’s 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 nine months ended September 30, 2011, we reimbursed Dr. Frost approximately $14 thousand and $127 thousand, respectively, for Company-related travel by Dr. Frost and other OPKO executives. For the three and nine months ended September 30, 2010, we reimbursed Dr. Frost approximately $5 thousand and $30 thousand, respectively, for Company-related travel by Dr. Frost and other OPKO executives.

Commitments and Contingencies
COMMITMENTS AND CONTINGENCIES

NOTE 10 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.

Segments
SEGMENTS

NOTE 11 SEGMENTS

We currently manage our operations in one reportable segment, pharmaceutical. 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. 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.

In connection with the classification of our ophthalmic instrumentation business as discontinued operations, we have reclassified activities related to our Aquashunt development program to our pharmaceutical research and development operating segment.

 

Information regarding our geographic activities is as follows:

 

                                 
    For the three months ended
September 30,
    For the nine months ended
September 30,
 
(in thousands)   2011     2010     2011     2010  

Product sales

                               

Chile

  $ 5,356     $ 4,517     $ 17,545     $ 13,711  

Mexico

    1,404       1,161       4,568       2,551  

All others

    —         —         —         —    
   

 

 

   

 

 

   

 

 

   

 

 

 
    $ 6,760     $ 5,678     $ 22,113     $ 16,262  
   

 

 

   

 

 

   

 

 

   

 

 

 

During the three and nine months ended September 30, 2011, our largest customer represented approximately 20% and 18% of our revenue from continuing operations, respectively. As of September 30, 2011, our largest customer represented approximately 35% of our accounts receivable balance from continuing operations. During the three months ended September 30, 2010, our two largest customers represented approximately 16% and 10%, respectively, of revenue from continuing operations. During the nine months ended September 30, 2010, our two largest customers represented 12% and 10% of our revenue from continuing operations. As of December 31, 2010, two customers represented 35% and 12%, respectively, of our accounts receivable balance from continuing operations.

Common Stock Issuance Repurchase and A Series Preferred Stock Redemption
COMMON STOCK ISSUANCE REPURCHASE AND SERIES A PREFERRED STOCK REDEMPTION

NOTE 12 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.

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 9.

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.

Subsequent Events
SUBSEQUENT EVENTS

NOTE 13 SUBSEQUENT EVENTS

On October 11, 2011, we completed the sale of our ophthalmic instrumentation businesses to Optos. Refer to Note 6.

On October 13, 2011, we acquired Claros Diagnostics, Inc. (“Claros”) pursuant to an agreement and plan of merger. We paid $10.0 million in cash, subject to certain set-offs and deductions, and $20.0 million in shares of our common stock (the “Stock Consideration”), based on the average closing sales price per share of our Common Stock as reported by the New York Stock Exchange for the ten trading days immediately preceding the closing date of the Merger, or $4.45 per share. Pursuant to the merger agreement, $5.0 million of the Stock Consideration is held in a separate escrow account to secure the indemnification obligations of Claros under the Claros Merger Agreement. In addition, the merger agreement provides for the payment of up to an additional $19.125 million in shares of our Common Stock upon and subject to the achievement of certain milestones.

On November 3, 2011, our Board of Directors declared a cash dividend to all Series D Preferred Stockholders as of November 3, 2011. The total cash dividend is expected to be approximately $4.7 million.

We have reviewed all subsequent events and transactions that occurred after the date of our September 30, 2011 condensed consolidated balance sheet date, through the time of filing this Quarterly Report on Form 10-Q.