ý | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 75-2402409 | |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) |
4400 Biscayne Blvd. Miami, FL 33137 (Address of Principal Executive Offices) (Zip Code) |
(305) 575-4100 (Registrant’s Telephone Number, Including Area Code) |
(in Rule 12b-2 of the Exchange Act) (Check one): | |||
Large accelerated filer | ¨ | Accelerated filer | ý |
Non-accelerated filer | ¨ (Do not check if a smaller reporting company) | Smaller reporting company | ¨ |
Page | |||
EX-2.11 | Agreement and Plan of Merger dated April 23, 2013 | ||
EX-31.1 | Section 302 Certification of CEO | ||
EX-31.2 | Section 302 Certification of CFO | ||
EX-32.1 | Section 906 Certification of CEO | ||
EX-32.2 | Section 906 Certification of CFO | ||
EX-101.INS | XBRL Instance Document | ||
EX-101.SCH | XBRL Taxonomy Extension Schema Document | ||
EX-101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | ||
EX-101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | ||
EX-101.LAB | XBRL Taxonomy Extension Label Linkbase Document | ||
EX-101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document |
• | 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 business is substantially dependent on our ability to develop, launch and generate revenue from our pharmaceutical and diagnostic programs. |
• | Our 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 may require substantial additional funding, which may not be available to us on acceptable terms, or at all. |
• | We may 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. |
• | The loss of Phillip Frost, M.D., our Chairman and Chief Executive Officer, could have a material adverse effect on our business and product development. |
• | 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. |
• |
• | Failure to close the proposed merger with PROLOR Biotech, Inc. could have a negative impact on the Company and our financial condition, results of operations, cash flows and stock price. |
• | 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 at our Israeli, Mexican, and Spanish facilities 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, Mexico, Spain, and Brazil for sales in those countries and our active pharmaceutical ingredients (“APIs”) business in Israel, and the sales force for our laboratory business based in Nashville, Tennessee. 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 and diagnostic product candidates. |
• | The success of our business will be heavily dependent on the success of ongoing and planned Phase 3 clinical trials for RayaldyTM and AlpharenTM. |
• | 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. (“TESARO”) 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 and provide our services profitably. |
• | Failure to obtain and maintain 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, may not proceed as planned, and may also increase the risk of potential third party claims and litigation. |
• | We may encounter difficulties in integrating acquired businesses. |
• | Non-U.S. governments often impose strict price controls, which may adversely affect our future profitability. |
• | Political and economic instability in Europe and Latin America and political, economic, and military instability in Israel could adversely impact our operations. |
• | We are subject to fluctuations in currency exchange rates in connection with our international businesses. |
• | 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 may 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, 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. |
June 30, 2013(1) (Unaudited) | December 31, 2012(1)(Audited) | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 119,061 | $ | 27,361 | |||
Marketable securities | 50,027 | — | |||||
Accounts receivable, net | 22,227 | 21,162 | |||||
Inventory, net | 19,778 | 22,261 | |||||
Prepaid expenses and other current assets | 19,023 | 7,873 | |||||
Total current assets | 230,116 | 78,657 | |||||
Property, plant, equipment, and investment properties, net | 16,577 | 16,526 | |||||
Intangible assets, net | 79,775 | 84,238 | |||||
In-process research and development | 203,052 | 11,546 | |||||
Goodwill | 82,086 | 80,450 | |||||
Investments, net | 26,690 | 15,636 | |||||
Other assets | 2,784 | 2,777 | |||||
Total assets | $ | 641,080 | $ | 289,830 | |||
LIABILITIES, SERIES D PREFERRED STOCK, AND EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 11,646 | $ | 10,200 | |||
Accrued expenses | 31,045 | 24,656 | |||||
Current portion of lines of credit and notes payable | 16,778 | 17,526 | |||||
Total current liabilities | 59,469 | 52,382 | |||||
3.00% convertible senior notes, net of discount and estimated fair value of embedded derivatives | 188,524 | — | |||||
Other long-term liabilities, principally contingent consideration and deferred tax liabilities | 80,603 | 34,168 | |||||
Total long-term liabilities | 269,127 | 34,168 | |||||
Total liabilities | 328,596 | 86,550 | |||||
Commitments and contingencies: | |||||||
Series D Preferred Stock - $0.01 par value, 2,000,000 shares authorized; no shares issued or outstanding at June 30, 2013 and 1,129,032 shares issued and outstanding (liquidation value of $30,595) at December 31, 2012 | — | 24,386 | |||||
Equity: | |||||||
Series A Preferred Stock - $0.01 par value, 4,000,000 shares authorized; no shares issued or outstanding at June 30, 2013 and December 31, 2012, respectively | — | — | |||||
Series C Preferred Stock - $0.01 par value, 500,000 shares authorized; no shares issued or outstanding at June 30, 2013 or December 31, 2012 | — | — | |||||
Common Stock - $0.01 par value, 500,000,000 shares authorized; 339,045,029 and 305,560,763 shares issued at June 30, 2013 and December 31, 2012, respectively | 3,391 | 3,056 | |||||
Treasury Stock - 2,293,056 shares at both June 30, 2013 and December 31, 2012 | (7,457 | ) | (7,457 | ) | |||
Additional paid-in capital | 742,097 | 565,201 | |||||
Accumulated other comprehensive income | 2,830 | 7,356 | |||||
Accumulated deficit | (426,379 | ) | (388,770 | ) | |||
Total shareholders’ equity | 314,482 | 179,386 | |||||
Noncontrolling interests | (1,998 | ) | (492 | ) | |||
Total equity | 312,484 | 178,894 | |||||
Total liabilities, Series D Preferred Stock, and equity | $ | 641,080 | $ | 289,830 |
(1) | As of June 30, 2013 and December 31, 2012, total assets include $6.0 million and $5.6 million, respectively, and total liabilities include $7.8 million and $5.5 million, respectively related to SciVac Ltd ("SciVac"), previously known as SciGen (I.L.) Ltd, a consolidated variable interest entity. SciVac’s consolidated assets are owned by SciVac and SciVac’s consolidated liabilities are those as to which there is no recourse against us. Refer to Note 5. |
For the three months ended June 30, | For the six months ended June 30, | ||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||
Revenues: | |||||||||||||||
Products | $ | 18,618 | $ | 9,917 | $ | 34,145 | $ | 18,556 | |||||||
Revenue from services | 3,188 | 145 | 6,280 | 232 | |||||||||||
Revenue from transfer of intellectual property | 2,015 | 149 | 14,772 | 200 | |||||||||||
Total revenues | 23,821 | 10,211 | 55,197 | 18,988 | |||||||||||
Costs and expenses: | |||||||||||||||
Costs of revenues | 13,103 | 6,554 | 24,860 | 11,541 | |||||||||||
Selling, general and administrative | 13,879 | 5,435 | 26,303 | 10,106 | |||||||||||
Research and development | 9,557 | 4,490 | 19,467 | 9,321 | |||||||||||
Contingent consideration | 2,577 | 965 | 3,921 | 2,109 | |||||||||||
Amortization of intangible assets | 2,688 | 2,108 | 5,402 | 4,099 | |||||||||||
Total costs and expenses | 41,804 | 19,552 | 79,953 | 37,176 | |||||||||||
Loss from operations | (17,983 | ) | (9,341 | ) | (24,756 | ) | (18,188 | ) | |||||||
Other income and (expense), net: | |||||||||||||||
Interest income | 90 | 47 | 149 | 74 | |||||||||||
Interest expense | (3,842 | ) | (231 | ) | (6,739 | ) | (582 | ) | |||||||
Fair value changes of derivative instruments, net | 12,651 | 23 | (10,898 | ) | 1,140 | ||||||||||
Other income (expense), net | 8,027 | (266 | ) | 10,358 | (85 | ) | |||||||||
Other income and (expense), net | 16,926 | (427 | ) | (7,130 | ) | 547 | |||||||||
Loss before income taxes and investment losses | (1,057 | ) | (9,768 | ) | (31,886 | ) | (17,641 | ) | |||||||
Income tax provision | 925 | 2 | 968 | 217 | |||||||||||
Loss before investment losses | (1,982 | ) | (9,770 | ) | (32,854 | ) | (17,858 | ) | |||||||
Loss from investments in investees | (2,371 | ) | (475 | ) | (6,261 | ) | (996 | ) | |||||||
Net loss | (4,353 | ) | (10,245 | ) | (39,115 | ) | (18,854 | ) | |||||||
Less: Net loss attributable to noncontrolling interests | (959 | ) | — | (1,506 | ) | — | |||||||||
Net loss attributable to common shareholders before preferred stock dividend | (3,394 | ) | (10,245 | ) | (37,609 | ) | (18,854 | ) | |||||||
Preferred stock dividend | — | (560 | ) | (420 | ) | (1,120 | ) | ||||||||
Net loss attributable to common shareholders | $ | (3,394 | ) | $ | (10,805 | ) | $ | (38,029 | ) | $ | (19,974 | ) | |||
Basic and diluted loss per share | $ | (0.01 | ) | $ | (0.04 | ) | $ | (0.12 | ) | $ | (0.07 | ) | |||
Weighted average number of common shares outstanding, basic and diluted | 336,732,215 | 297,836,707 | 324,898,133 | 297,689,886 |
For the three months ended June 30, | For the six months ended June 30, | ||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||
Net loss attributable to common shareholders | $ | (3,394 | ) | $ | (10,805 | ) | $ | (38,029 | ) | $ | (19,974 | ) | |||
Other comprehensive income (loss), net of tax: | |||||||||||||||
Change in foreign currency translation | (2,085 | ) | (780 | ) | (1,762 | ) | 610 | ||||||||
Available for sale investments: | |||||||||||||||
Change in other unrealized gains, net | 424 | 5,096 | 1,829 | 5,205 | |||||||||||
Less: reclassification adjustments for gains included in net loss, net of tax | (3,602 | ) | — | (4,593 | ) | — | |||||||||
Comprehensive loss | $ | (8,657 | ) | $ | (6,489 | ) | $ | (42,555 | ) | $ | (14,159 | ) |
Common Stock | Treasury | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Noncontrolling Interests | Total | |||||||||||||||||||||||||||
Shares | Dollars | Shares | Dollars | ||||||||||||||||||||||||||||||
Balance at December 31, 2012 | 305,560,763 | $ | 3,056 | (2,293,056 | ) | $ | (7,457 | ) | $ | 565,201 | $ | 7,356 | $ | (388,770 | ) | $ | (492 | ) | $ | 178,894 | |||||||||||||
Equity-based compensation expense | — | — | — | — | 7,003 | — | — | — | 7,003 | ||||||||||||||||||||||||
Exercise of Common Stock options | 447,690 | 4 | — | — | 924 | — | — | — | 928 | ||||||||||||||||||||||||
Exercise of Common Stock warrants | 1,164,542 | 12 | — | — | 579 | — | — | — | 591 | ||||||||||||||||||||||||
Series D Preferred Stock dividend | — | — | — | — | (3,015 | ) | — | — | — | (3,015 | ) | ||||||||||||||||||||||
Conversion of Series D Preferred Stock | 11,290,320 | 113 | — | — | 24,273 | — | — | — | 24,386 | ||||||||||||||||||||||||
Issuance of Common Stock in connection with OPKO Brazil acquisition at $6.73 per share | 64,684 | 1 | — | — | 435 | — | — | — | 436 | ||||||||||||||||||||||||
Issuance of Common Stock in connection with Cytochroma acquisition at $7.16 per share | 20,517,030 | 205 | — | — | 146,697 | — | — | — | 146,902 | ||||||||||||||||||||||||
Net loss attributable to common shareholders before preferred stock dividend | — | — | — | — | — | — | (37,609 | ) | — | (37,609 | ) | ||||||||||||||||||||||
Net loss attributable to noncontrolling interests | — | — | — | — | — | — | — | (1,506 | ) | (1,506 | ) | ||||||||||||||||||||||
Other comprehensive loss | — | — | — | — | — | (4,526 | ) | — | — | (4,526 | ) | ||||||||||||||||||||||
Balance at June 30, 2013 (unaudited) | 339,045,029 | $ | 3,391 | (2,293,056 | ) | $ | (7,457 | ) | $ | 742,097 | $ | 2,830 | $ | (426,379 | ) | $ | (1,998 | ) | $ | 312,484 |
For the six months ended June 30, | |||||||
2013 | 2012 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (39,115 | ) | $ | (18,854 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 6,880 | 4,782 | |||||
Non-cash interest on convertible senior notes | 3,120 | — | |||||
Amortization of deferred financing costs | 343 | — | |||||
Losses from investments in investees | 6,261 | 996 | |||||
Equity-based compensation – employees and non-employees | 7,003 | 2,169 | |||||
Provision for (recovery of) bad debts | 329 | (91 | ) | ||||
Provision for inventory obsolescence | 1,273 | 754 | |||||
Revenue from receipt of equity | (12,620 | ) | (102 | ) | |||
Realized gain on investments available for sale | (10,821 | ) | — | ||||
Change in fair value of derivatives instruments | 10,898 | (1,140 | ) | ||||
Change in fair value of contingent consideration | 3,921 | 2,109 | |||||
Deferred income tax benefit | (602 | ) | — | ||||
Changes in assets and liabilities of continuing operations, net of the effects of acquisitions: | |||||||
Accounts receivable | (1,652 | ) | (2,681 | ) | |||
Inventory | 1,213 | (3,321 | ) | ||||
Prepaid expenses and other current assets | (2,572 | ) | (1,318 | ) | |||
Other assets | 97 | 11 | |||||
Accounts payable | 333 | (796 | ) | ||||
Foreign currency measurement | 450 | (109 | ) | ||||
Accrued expenses | 4,591 | (87 | ) | ||||
Cash used in operating activities of continuing operations | (20,670 | ) | (17,678 | ) | |||
Cash used in operating activities of discontinued operations | — | (82 | ) | ||||
Net cash used in operating activities | (20,670 | ) | (17,760 | ) | |||
Cash flows from investing activities: | |||||||
Investments in investees | (13,341 | ) | (2,700 | ) | |||
Proceeds from sale of investments available for sale | 11,496 | — | |||||
Acquisition of businesses, net of cash | 78 | (2,173 | ) | ||||
Purchase of marketable securities | (50,027 | ) | (17,117 | ) | |||
Capital expenditures | (2,054 | ) | (408 | ) | |||
Net cash used in investing activities | (53,848 | ) | (22,398 | ) | |||
Cash flows from financing activities: | |||||||
Issuance of 3.00% convertible senior notes, net, including related parties | 170,184 | — | |||||
Payment of Series D dividends, including related parties | (3,015 | ) | — | ||||
Proceeds from the exercise of Common Stock options and warrants | 1,519 | 1,492 | |||||
Borrowings on lines of credit | 15,354 | 21,553 | |||||
Repayments of lines of credit and capital lease obligations | (17,718 | ) | (16,288 | ) | |||
Net cash provided by financing activities | 166,324 | 6,757 | |||||
Effect of exchange rate on cash and cash equivalents | (106 | ) | 56 | ||||
Net increase (decrease) in cash and cash equivalents | 91,700 | (33,345 | ) | ||||
Cash and cash equivalents at beginning of period | 27,361 | 71,516 | |||||
Cash and cash equivalents at end of period | $ | 119,061 | $ | 38,171 | |||
SUPPLEMENTAL INFORMATION | |||||||
Interest paid | $ | 318 | $ | 341 | |||
Income taxes paid (refunded), net | $ | 242 | $ | (197 | ) | ||
RXi common stock received | $ | 12,500 | $ | — | |||
Non-cash financing: | |||||||
Shares issued upon the conversion of: | |||||||
Series D Preferred Stock | $ | 24,386 | $ | — | |||
Common Stock warrants, net exercised | $ | 815 | $ | — | |||
Issuance of Common Stock to acquire: | |||||||
Cytochroma | $ | 146,902 | $ | — | |||
OPKO Brazil | $ | 436 | $ | — |
(In thousands) | June 30, 2013 | December 31, 2012 | |||||
Accounts receivable, net: | |||||||
Accounts receivable | $ | 23,135 | $ | 21,636 | |||
Less: allowance for doubtful accounts | (908 | ) | (474 | ) | |||
$ | 22,227 | $ | 21,162 | ||||
Inventories, net: | |||||||
Finished products | $ | 15,169 | $ | 17,963 | |||
Work in-process | 1,253 | 688 | |||||
Raw materials | 4,721 | 4,923 | |||||
Less: inventory reserve | (1,365 | ) | (1,313 | ) | |||
$ | 19,778 | $ | 22,261 | ||||
Intangible assets, net: | |||||||
Technologies | $ | 52,796 | $ | 52,810 | |||
Customer relationships | 22,839 | 23,088 | |||||
Product registrations | 9,690 | 9,637 | |||||
Tradenames | 3,683 | 3,746 | |||||
Covenants not to compete | 8,660 | 8,662 | |||||
Other | 1,180 | 367 | |||||
Less: accumulated amortization | (19,073 | ) | (14,072 | ) | |||
$ | 79,775 | $ | 84,238 | ||||
Accrued expenses: | |||||||
Income taxes payable | $ | 2,421 | $ | 1,614 | |||
Deferred revenue | 3,903 | 1,518 | |||||
Clinical trials | 315 | 50 | |||||
Professional fees | 933 | 675 | |||||
Employee benefits | 3,972 | 3,319 | |||||
Deferred acquisition payments, net of discount | 5,432 | 6,172 | |||||
Contingent consideration | 5,298 | 5,126 | |||||
Interest payable related to the Notes | 2,275 | — | |||||
Other | 6,496 | 6,182 | |||||
$ | 31,045 | $ | 24,656 | ||||
Other long-term liabilities: | |||||||
Contingent consideration – Cytochroma | $ | 49,784 | $ | — | |||
Contingent consideration – Farmadiet | 529 | 532 | |||||
Contingent consideration – OPKO Diagnostics | 12,746 | 11,310 | |||||
Contingent consideration – FineTech | — | 2,578 | |||||
Contingent consideration – CURNA | 549 | 510 | |||||
Deferred acquisition payments, net of discount | 3,983 | 3,931 | |||||
Mortgages and other debts payable | 3,636 | 5,150 | |||||
Deferred tax liabilities | 7,185 | 9,777 | |||||
Other, including deferred revenue | 2,191 | 380 | |||||
$ | 80,603 | $ | 34,168 |
(In thousands) | |||
Current assets (including cash of $378 thousand) | $ | 1,224 | |
Intangible assets: | |||
In-process research and development | 191,530 | ||
Patents | 210 | ||
Total intangible assets | 191,740 | ||
Goodwill | 2,411 | ||
Property, plant and equipment | 306 | ||
Accounts payable and accrued expenses | (1,069 | ) | |
Total purchase price | $ | 194,612 |
For the three months ended June 30, | For the six months ended June 30, | ||||||||||||||
(In thousands) | 2013 | 2012 | 2013 | 2012 | |||||||||||
Revenues | $ | 23,821 | $ | 12,393 | $ | 55,197 | $ | 23,351 | |||||||
Net loss | $ | (4,353 | ) | $ | (10,840 | ) | $ | (42,583 | ) | $ | (20,050 | ) | |||
Net loss attributable to common shareholders | $ | (3,394 | ) | $ | (11,398 | ) | $ | (41,496 | ) | $ | (21,164 | ) | |||
Basic and diluted loss per share | $ | (0.01 | ) | $ | (0.04 | ) | $ | (0.13 | ) | $ | (0.07 | ) |
(Dollars in thousands, except per share prices) Investee name | Year invested | Accounting method | Ownership at June 30, 2013 | Investment | Underlying equity in net assets | Closing share price at June 30, 2013 for investments available for sale | ||||||||||||||
Sorrento | 2009 | Equity method | 20 | % | $ | 2,300 | $ | 1,219 | ||||||||||||
Cocrystal | 2009 | Equity method | 16 | % | 2,500 | 514 | ||||||||||||||
Neovasc | 2011 | Equity method | 4 | % | 3,235 | 486 | ||||||||||||||
Fabrus | 2010 | VIE, equity method | 13 | % | 650 | (64 | ) | |||||||||||||
BZNE common stock | 2012 | VIE, equity method | 12 | % | 1,276 | (641 | ) | |||||||||||||
RXi | 2013 | Equity method | 21 | % | 15,000 | 3,230 | ||||||||||||||
Pharmsynthez | 2013 | Equity method | 10 | % | 5,036 | 5,171 | ||||||||||||||
TESARO | 2010 | Investment available for sale | 1 | % | 56 | $ | 32.74 | |||||||||||||
Neovasc options | 2011 | Investment available for sale | N/A | 925 | CA | $ | 2.95 | |||||||||||||
BZNE Note and conversion feature | 2012 | VIE, investment available for sale | N/A | 1,700 | — | |||||||||||||||
ChromaDex | 2012 | Investment available for sale | 1 | % | 1,320 | $ | 0.78 | |||||||||||||
Plus unrealized gains on investments, options and warrants, net | 3,671 | |||||||||||||||||||
Less accumulated losses in investees | (10,979 | ) | ||||||||||||||||||
Total carrying value of equity method investees and investments, available for sale | $ | 26,690 |
(In thousands) | June 30, 2013 | December 31, 2012 | |||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 363 | $ | 174 | |||
Accounts receivable, net | 266 | 387 | |||||
Inventories, net | 1,573 | 1,092 | |||||
Prepaid expenses and other current assets | 132 | 199 | |||||
Total current assets | 2,334 | 1,852 | |||||
Property, plant and equipment, net | 1,425 | 1,539 | |||||
Intangible assets, net | 1,128 | 1,154 | |||||
Goodwill | 822 | 796 | |||||
Other assets | 298 | 231 | |||||
Total assets | $ | 6,007 | $ | 5,572 | |||
Liabilities | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,254 | $ | 1,108 | |||
Accrued expenses | 5,157 | 2,859 | |||||
Notes payable | 1,132 | — | |||||
Total current liabilities | 7,543 | 3,967 | |||||
Other long-term liabilities | 282 | 1,529 | |||||
Total liabilities | $ | 7,825 | $ | 5,496 |
June 30, 2013 | Issuance Date | ||||||
Stock price | $ | 7.10 | $ | 6.20 | |||
Conversion Rate | 141.4827 | 141.4827 | |||||
Conversion Price | $ | 7.07 | $ | 7.07 | |||
Maturity date | February 1, 2033 | February 1, 2033 | |||||
Risk-free interest rate | 1.57 | % | 1.12 | % | |||
Estimated stock volatility | 35 | % | 40 | % | |||
Estimated credit spread | 983 basis points | 944 basis points |
(In thousands) | June 30, 2013 | Issuance Date | |||||
Fair value of Notes: | |||||||
With the embedded derivatives | $ | 189,481 | $ | 175,000 | |||
Without the embedded derivatives | $ | 115,402 | $ | 115,796 | |||
Estimated fair value of the embedded derivatives | $ | 74,079 | $ | 59,204 |
(In thousands) | Principal Balance | Unamortized Discount | Net Carrying Amount | ||||||||
Notes | $ | 175,000 | $ | 60,555 | $ | 114,445 |
(Dollars in thousands) | Balance Outstanding | ||||||||||||||
Lender | Interest rate on borrowings | Credit line capacity | June 30, 2013 | December 31, 2012 | |||||||||||
Itau Bank | 6.66 | % | $ | 3,000 | $ | 2,664 | $ | 2,738 | |||||||
Bank of Chile | 7.50 | % | 3,000 | 2,237 | 2,292 | ||||||||||
BICE Bank | 5.02 | % | 2,000 | 940 | 2,451 | ||||||||||
Corp Banca | 5.00 | % | 1,000 | 140 | 1,248 | ||||||||||
BBVA Bank | 5.55 | % | 3,000 | 1,949 | 2,823 | ||||||||||
Penta Bank | 9.48 | % | 1,000 | 793 | 833 | ||||||||||
Security Bank | 7.60 | % | 1,500 | 994 | — | ||||||||||
BCI | 5.00 | % | 1,500 | 1,591 | — | ||||||||||
Estado Bank | 5.99 | % | 2,000 | 1,851 | 1,963 | ||||||||||
Sabadell Bank | 7.60 | % | 195 | — | 3 | ||||||||||
Bilbao Vizcaya Bank | 4.90 | % | 390 | 91 | 377 | ||||||||||
Banco Popular | 8.25 | % | 390 | 11 | 260 | ||||||||||
Santander Bank | 6.00 | % | 195 | — | — | ||||||||||
Banesto | 5.80 | % | 195 | — | 163 | ||||||||||
Banca March | 6.25 | % | 260 | — | 44 | ||||||||||
Total | $ | 19,625 | $ | 13,261 | $ | 15,195 |
(In thousands) | June 30, 2013 | December 31, 2012 | |||||
Current portion of lines of credit and notes payable | $ | 2,385 | $ | 2,331 | |||
Other long-term liabilities | 3,636 | 3,916 | |||||
Total mortgage notes and other debt payables | $ | 6,021 | $ | 6,247 |
(In thousands) | Foreign currency | Unrealized gains in Accumulated OCI | |||||
Balance at December 31, 2012 | $ | 3,196 | $ | 4,160 | |||
Other comprehensive income before reclassifications, net of tax (1) | (1,762 | ) | 1,829 | ||||
Amounts reclassified from accumulated other comprehensive income, net of tax (1) | — | (4,593 | ) | ||||
Net other comprehensive income | (1,762 | ) | (2,764 | ) | |||
Balance at June 30, 2013 | $ | 1,434 | $ | 1,396 |
(1) | Effective tax rate of 38.47%. |
As of June 30, 2013 | |||||||||||||||||||
(In thousands) | Amortized Cost | Gross unrealized gains in Accumulated OCI | Gross unrealized losses in Accumulated OCI | Gain/(Loss) in Accumulated Deficit | Fair value | ||||||||||||||
Common stock investments, available for sale | $ | 1,376 | $ | 1,160 | $ | — | $ | — | $ | 2,536 | |||||||||
BZNE Note and conversion feature | 1,700 | 53 | — | 287 | 2,040 | ||||||||||||||
Neovasc common stock options | 925 | 715 | — | 679 | 2,319 | ||||||||||||||
U.S. Treasury securities | 75,040 | — | (7 | ) | (7 | ) | 75,026 | ||||||||||||
Total assets | $ | 79,041 | $ | 1,928 | $ | (7 | ) | $ | 959 | $ | 81,921 |
As of December 31, 2012 | |||||||||||||||||||
(In thousands) | Amortized Cost | Gross unrealized gains in Accumulated OCI | Gross unrealized losses in Accumulated OCI | Gain/(Loss) in Accumulated Deficit | Fair value | ||||||||||||||
Common stock investments, available for sale | $ | 2,051 | $ | 6,185 | $ | — | $ | — | $ | 8,236 | |||||||||
BZNE Note and conversion feature | 1,700 | 53 | — | 287 | 2,040 | ||||||||||||||
Neovasc common stock options | 925 | 293 | — | 176 | 1,394 | ||||||||||||||
Neovasc common stock warrants | 659 | 194 | — | (375 | ) | 478 | |||||||||||||
Total assets | $ | 5,335 | $ | 6,725 | $ | — | $ | 88 | $ | 12,148 |
Fair value measurements as of June 30, 2013 | |||||||||||||||
(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 | $ | 80,183 | $ | — | $ | — | $ | 80,183 | |||||||
U.S. Treasury securities | 24,999 | 50,027 | — | 75,026 | |||||||||||
Certificates of deposit | — | 827 | — | 827 | |||||||||||
Pharmsynthez Note Receivable and Purchase Option | — | 6,795 | — | 6,795 | |||||||||||
Forward contracts | — | 133 | — | 133 | |||||||||||
Common stock investments, available for sale | 2,536 | — | — | 2,536 | |||||||||||
BZNE Note and conversation feature | — | — | 2,040 | 2,040 | |||||||||||
Neovasc common stock options | — | 2,319 | — | 2,319 | |||||||||||
Total assets | $ | 107,718 | $ | 60,101 | $ | 2,040 | $ | 169,859 | |||||||
Liabilities: | |||||||||||||||
Embedded conversion option | $ | — | $ | — | $ | 74,079 | $ | 74,079 | |||||||
Deferred acquisition payments, net of discount | — | — | 9,415 | 9,415 | |||||||||||
Contingent consideration: | |||||||||||||||
CURNA | — | — | 549 | 549 | |||||||||||
OPKO Diagnostics | — | — | 14,512 | 14,512 | |||||||||||
FineTech | — | — | 2,763 | 2,763 | |||||||||||
Cytochroma | — | — | 49,784 | 49,784 | |||||||||||
Farmadiet | — | — | 1,298 | 1,298 | |||||||||||
Total liabilities | $ | — | $ | — | $ | 152,400 | $ | 152,400 |
Fair value measurements as of December 31, 2012 | |||||||||||||||
(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 | $ | 18,716 | $ | — | $ | — | $ | 18,716 | |||||||
Certificates of deposit | — | 820 | — | 820 | |||||||||||
Common stock investments, available for sale | 8,236 | — | — | 8,236 | |||||||||||
BZNE Note and conversation feature | — | — | 2,040 | 2,040 | |||||||||||
Neovasc common stock options | — | 1,394 | — | 1,394 | |||||||||||
Neovasc common stock warrants | — | 478 | — | 478 | |||||||||||
Total assets | $ | 26,952 | $ | 2,692 | $ | 2,040 | $ | 31,684 | |||||||
Liabilities: | |||||||||||||||
Forward contracts | $ | — | $ | 10 | $ | — | $ | 10 | |||||||
Deferred acquisition payments, net of discount | — | — | 10,103 | 10,103 | |||||||||||
Contingent consideration: | |||||||||||||||
CURNA | — | — | 510 | 510 | |||||||||||
OPKO Diagnostics | — | — | 12,974 | 12,974 | |||||||||||
FineTech | — | — | 5,262 | 5,262 | |||||||||||
Farmadiet | — | — | 1,310 | 1,310 | |||||||||||
Total liabilities | $ | — | $ | 10 | $ | 30,159 | $ | 30,169 |
June 30, 2013 | |||||||||||||||||||
(In thousands) | Carrying Value | Total Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||||
Notes | $ | 114,445 | $ | 115,402 | $ | — | $ | — | $ | 115,402 |
June 30, 2013 | |||||||||||||||
(In thousands) | BZNE Note and conversion feature | Contingent consideration | Deferred acquisition payments, net of discount | Embedded conversion option | |||||||||||
Balance at December 31, 2012 | $ | 2,040 | $ | 20,056 | $ | 10,103 | $ | — | |||||||
Additions | — | 47,710 | — | 59,204 | |||||||||||
Total losses (gains) for the period: | |||||||||||||||
Included in results of operations | — | 3,901 | 112 | 14,875 | |||||||||||
Payments | — | (2,761 | ) | (800 | ) | — | |||||||||
Balance at June 30, 2013 | $ | 2,040 | $ | 68,906 | $ | 9,415 | $ | 74,079 |
December 31, 2012 | |||||||||||
(In thousands) | BZNE Note and conversion feature | Contingent consideration | Deferred acquisition payments, net of discount | ||||||||
Balance at December 31, 2011 | $ | — | $ | 18,002 | $ | — | |||||
Additions | 1,700 | 1,234 | 9,673 | ||||||||
Total losses (gains) for the period: | |||||||||||
Included in results of operations | 1,563 | 820 | 430 | ||||||||
Included in Other comprehensive loss | 53 | — | — | ||||||||
Transfer out to equity method investment | (1,276 | ) | — | — | |||||||
Balance at December 31, 2012 | $ | 2,040 | $ | 20,056 | $ | 10,103 |
(In thousands) | Balance Sheet Component | June 30, 2013 | December 31, 2012 | ||||||
Derivative financial instruments: | |||||||||
Pharmsynthez Note Receivable and Purchase Option | Prepaid expenses and other current assets | $ | 6,795 | $ | — | ||||
Neovasc common stock options/warrants | Investments, net | $ | 2,319 | $ | 1,872 | ||||
Embedded conversion option | 3.00% convertible senior notes, net of discount and estimated fair value of embedded derivatives | $ | 74,079 | $ | — | ||||
Forward contracts (1) | Current portion of lines of credit and notes payable | $ | 2,242 | $ | 1,294 |
(1) | The effect on loss in the forward contracts is recorded in Accrued expenses. The effect on income in the forward contracts is recorded in Prepaid expenses and other current assets. |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||
(In thousands) | 2013 | 2012 | 2013 | 2012 | |||||||||||
Derivative gain (loss): | |||||||||||||||
Pharmsynthez Note Receivable and Purchase Option | $ | 2,599 | $ | — | $ | 2,599 | $ | — | |||||||
Neovasc common stock options/warrants and BZNE Note conversion feature | (15 | ) | 137 | 1,245 | 1,167 | ||||||||||
Notes | 9,913 | — | (14,875 | ) | — | ||||||||||
Forward contracts | 154 | (114 | ) | 133 | (27 | ) | |||||||||
Total | $ | 12,651 | $ | 23 | $ | (10,898 | ) | $ | 1,140 |
(In thousands) Days until maturity | Contract value | Fair value at June 30, 2013 | Effect on income (loss) | |||||||||
0 to 30 | $ | 659 | $ | 703 | $ | 44 | ||||||
31 to 60 | 410 | 436 | 26 | |||||||||
61 to 90 | 618 | 654 | 36 | |||||||||
91 to 120 | 422 | 449 | 27 | |||||||||
121 to 180 | — | — | — | |||||||||
More than 180 | — | — | — | |||||||||
Total | $ | 2,109 | $ | 2,242 | $ | 133 |
(In thousands) Days until maturity | Contract value | Fair value at December 31, 2012 | Effect on income (loss) | |||||||||
0 to 30 | $ | — | $ | — | $ | — | ||||||
31 to 60 | 581 | 577 | (4 | ) | ||||||||
61 to 90 | 341 | 339 | (2 | ) | ||||||||
91 to 120 | 212 | 210 | (2 | ) | ||||||||
121 to 180 | 170 | 168 | (2 | ) | ||||||||
More than 180 | — | — | — | |||||||||
Total | $ | 1,304 | $ | 1,294 | $ | (10 | ) |
For the three months ended June 30, | For the six months ended June 30, | ||||||||||||||
(In thousands) | 2013 | 2012 | 2013 | 2012 | |||||||||||
Product revenues: | |||||||||||||||
Pharmaceuticals | $ | 18,618 | $ | 9,917 | $ | 34,145 | $ | 18,556 | |||||||
Diagnostics | — | — | — | — | |||||||||||
Corporate | — | — | — | — | |||||||||||
$ | 18,618 | $ | 9,917 | $ | 34,145 | $ | 18,556 | ||||||||
Revenue from services and transfer of intellectual property: | |||||||||||||||
Pharmaceuticals | $ | 1,300 | $ | — | $ | 13,800 | $ | — | |||||||
Diagnostics | 3,823 | 243 | 7,132 | 330 | |||||||||||
Corporate | 80 | 51 | 120 | 102 | |||||||||||
$ | 5,203 | $ | 294 | $ | 21,052 | $ | 432 | ||||||||
Operating (loss) income: | |||||||||||||||
Pharmaceuticals | $ | (4,528 | ) | $ | (1,955 | ) | $ | 3,955 | $ | (3,317 | ) | ||||
Diagnostics | (6,750 | ) | (4,356 | ) | (16,384 | ) | (9,025 | ) | |||||||
Corporate | (5,762 | ) | (3,030 | ) | (10,787 | ) | (5,846 | ) | |||||||
Less: Operating loss attributable to noncontrolling interests | (943 | ) | — | (1,540 | ) | — | |||||||||
$ | (17,983 | ) | $ | (9,341 | ) | $ | (24,756 | ) | $ | (18,188 | ) | ||||
Depreciation and amortization: | |||||||||||||||
Pharmaceuticals | $ | 1,702 | $ | 1,575 | $ | 3,397 | $ | 3,025 | |||||||
Diagnostics | 1,704 | 835 | 3,393 | 1,669 | |||||||||||
Corporate | 45 | 44 | 90 | 88 | |||||||||||
$ | 3,451 | $ | 2,454 | $ | 6,880 | $ | 4,782 | ||||||||
Revenues: | |||||||||||||||
United States | $ | 5,203 | $ | 294 | $ | 21,052 | $ | 432 | |||||||
Chile | 8,482 | 7,187 | 16,223 | 12,888 | |||||||||||
Spain | 5,153 | — | 9,477 | — | |||||||||||
Israel | 3,995 | 1,518 | 6,567 | 3,145 | |||||||||||
Mexico | 988 | 1,212 | 1,878 | 2,523 | |||||||||||
$ | 23,821 | $ | 10,211 | $ | 55,197 | $ | 18,988 |
(In thousands) | June 30, 2013 | December 31, 2012 | |||||
Assets: | |||||||
Pharmaceuticals | $ | 336,266 | $ | 142,299 | |||
Diagnostics | 114,095 | 112,422 | |||||
Corporate | 190,719 | 35,109 | |||||
$ | 641,080 | $ | 289,830 | ||||
Goodwill: | |||||||
Pharmaceuticals | $ | 34,480 | $ | 32,844 | |||
Diagnostics | 47,606 | 47,606 | |||||
Corporate | — | — | |||||
$ | 82,086 | $ | 80,450 |
Contractual obligations (In thousands) | Remaining Six Months ending December 31, 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | Thereafter | Total | ||||||||||||||||||||||||
Open purchase orders | $ | 12,004 | $ | 2 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 12,006 | ||||||||||||||||
Operating leases | 1,255 | 1,978 | 1,458 | 1,240 | 555 | 266 | 321 | 7,073 | ||||||||||||||||||||||||
3.00% convertible senior notes | — | — | — | — | — | — | 188,524 | 188,524 | ||||||||||||||||||||||||
Mortgages and other debts payable (1) | 2,121 | 590 | 504 | 395 | 358 | 303 | 1,750 | 6,021 | ||||||||||||||||||||||||
Lines of credit | 13,261 | — | — | — | — | — | — | 13,261 | ||||||||||||||||||||||||
Interest commitments | 3,289 | 5,393 | 5,374 | 5,358 | 5,344 | 5,329 | 518 | 30,605 | ||||||||||||||||||||||||
Total | $ | 31,930 | $ | 7,963 | $ | 7,336 | $ | 6,993 | $ | 6,257 | $ | 5,898 | $ | 191,113 | $ | 257,490 |
(1) | Excludes $1.3 million of consolidated liabilities related to SciVac, as to which there is no recourse against us. |
• | Unit of account – Most intangible assets are valued as single global assets rather than multiple assets for each jurisdiction or indication after considering the development stage, expected levels of incremental costs to obtain additional approvals, risks associated with further development, amount and timing of benefits expected to be derived in the future, expected patent lives in various jurisdictions and the intention to promote the asset as a global brand. |
• | Estimated useful life – The asset life expected to contribute meaningful cash flows is determined after considering all pertinent matters associated with the asset, including expected regulatory approval dates (if unapproved), exclusivity periods and other legal, regulatory or contractual provisions as well as the effects of any obsolescence, demand, competition, and other economic factors, including barriers to entry. |
• | Probability of Technical and Regulatory Success (“PTRS”) Rate – PTRS rates are determined based upon industry averages considering the respective programs development stage and disease indication and adjusted for specific information or data known at the acquisition date. Subsequent clinical results or other internal or external data obtained could alter the PTRS rate and materially impact the estimated fair value of the intangible asset in subsequent periods leading to impairment charges. |
• | Projections – Future revenues are estimated after considering many factors such as initial market opportunity, pricing, sales trajectories to peak sales levels, competitive environment and product evolution. Future costs and expenses are estimated after considering historical market trends, market participant synergies and the timing and level of additional development costs to obtain the initial or additional regulatory approvals, maintain or further enhance the product. We generally assume initial positive cash flows to commence shortly after the receipt of expected regulatory approvals which typically may not occur for a number of years. Actual cash flows attributed to the project are likely to be different than those assumed since projections are subjected to multiple factors including trial results and regulatory matters which could materially change the ultimate commercial success of the asset as well as significantly alter the costs to develop the respective asset into commercially viable products. |
• | Tax rates – The expected future income is tax effected using a market participant tax rate. Our recent valuations typically use a U.S. tax rate (and applicable state taxes) after considering the jurisdiction in which the intellectual property is held and location of research and manufacturing infrastructure. We also considered that any earnings repatriation would likely have U.S. tax consequences. |
• | Discount rate – Discount rates are selected after considering the risks inherent in the future cash flows; the assessment of the asset’s life cycle and the competitive trends impacting the asset, including consideration of any technical, legal, regulatory, or economic barriers to entry, as well as expected changes in standards of practice for indications addressed by the asset. |
Exhibit 2.11(1) | Agreement and Plan of Merger, dated April 23, 2013, among OPKO Health, Inc., POM Acquisition, Inc., and PROLOR Biotech, Inc. |
Exhibit 3.1(2) | Amended and Restated Certificate of Incorporation. |
Exhibit 3.2(3) | Amended and Restated By-Laws. |
Exhibit 4.3(4) | Indenture, dated as of January 30, 2013, between OPKO Health, Inc. and Wells Fargo Bank, National Association. |
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, 2013. |
Exhibit 31.2 | Certification by Juan F. Rodriguez, 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, 2013. |
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, 2013. |
Exhibit 32.2 | Certification by Juan F. Rodriguez, 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, 2013. |
Exhibit 101.INS* | XBRL Instance Document |
Exhibit 101.SCH* | XBRL Taxonomy Extension Schema Document |
Exhibit 101.CAL* | XBRL Taxonomy Extension Calculation Linkbase Document |
Exhibit 101.DEF* | XBRL Taxonomy Extension Definition Linkbase Document |
Exhibit 101.LAB* | XBRL Taxonomy Extension Label Linkbase Document |
Exhibit 101.PRE* | XBRL Taxonomy Extension Presentation Linkbase Document |
* | 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 Company's Preliminary Joint Proxy Statement/Prospectus, Form S-4, with the Securities Exchange Commission on June 27, 2013, as amended. |
(2) | Filed with the Company’s Current Report on Form 8-A filed with the Securities and Exchange Commission on June 11, 2007, and incorporated herein by reference. |
(3) | Filed with the Company’s 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 Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 5, 2013, and incorporated herein by reference. |
Date: August 9, 2013 | OPKO Health, Inc. | |
/s/ Adam Logal | ||
Adam Logal | ||
Vice President, Finance, Chief Accounting | ||
Officer and Treasurer |
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, 2013. |
Exhibit 31.2 | Certification by Juan F. Rodriguez, 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, 2013. |
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, 2013. |
Exhibit 32.2 | Certification by Juan F. Rodriguez, 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, 2013. |
Exhibit 101.INS* | XBRL Instance Document |
Exhibit 101.SCH* | XBRL Taxonomy Extension Schema Document |
Exhibit 101.CAL* | XBRL Taxonomy Extension Calculation Linkbase Document |
Exhibit 101.DEF* | XBRL Taxonomy Extension Definition Linkbase Document |
Exhibit 101.LAB* | XBRL Taxonomy Extension Label Linkbase Document |
Exhibit 101.PRE* | XBRL Taxonomy Extension Presentation Linkbase Document |
* | 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) | I have reviewed this Quarterly Report on Form 10-Q of OPKO Health, Inc.; |
(2) | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
(3) | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
(4) | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
(5) | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 9, 2013 | /s/ Dr. Phillip Frost, M.D. |
Dr. Phillip Frost, M.D. | |
Chief Executive Officer |
(1) | I have reviewed this Quarterly Report on Form 10-Q of OPKO Health, Inc.; |
(2) | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
(3) | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
(4) | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
(5) | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 9, 2013 | /s/ Juan F. Rodriguez |
Juan F. Rodriguez | |
Chief Financial Officer |
Date: August 9, 2013 | /s/ Dr. Phillip Frost, M.D. |
Dr. Phillip Frost, M.D. | |
Chief Executive Officer |
Date: August 9, 2013 | /s/ Juan F. Rodriguez |
Juan F. Rodriguez | |
Chief Financial Officer |
Fair Value Measurements
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Jun. 30, 2013
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FAIR VALUE MEASUREMENTS | 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. A summary of our investments as of June 30, 2013, classified as available for sale, and carried at fair value is as follows:
A summary of our investments as of December 31, 2012, classified as available for sale, and carried at fair value is as follows:
Any future fluctuation in fair value related to these instruments that is judged to be temporary, including any recoveries of previous write-downs, will be recorded in Accumulated other comprehensive income or loss. If we determine that any future valuation adjustment was other-than-temporary, we will record a loss during the period such determination is made. As of June 30, 2013, we have money market funds that qualify as cash equivalents, forward contracts for inventory purchases (Refer to Note 9) and contingent consideration related to the acquisitions of CURNA, Inc. (“CURNA”), Claros Diagnostics, Inc. (“OPKO Diagnostics”), FineTech Pharmaceuticals, Ltd. (“FineTech”), Farmadiet, and Cytochroma that are required to be measured at fair value on a recurring basis. In addition, in connection with our investment and our consulting agreement with Neovasc, we record the related Neovasc options and warrants at fair value as well as the derivative instruments related to our transactions with Pharmsynthez. Our financial assets and liabilities measured at fair value on a recurring basis are as follows:
Our U.S. Treasury securities mature on September 5, 2013 ($25.0 million), September 30, 2013 ($25.0 million) and October 15, 2013 ($25.0 million). The carrying amount and estimated fair value of our long-term debt, as well as the applicable fair value hierarchy tiers, are contained in the table below. The fair value of the Notes is determined using a binomial lattice approach in order to estimate the fair value of the embedded derivative in the Notes. Refer to Note 6.
As of June 30, 2013 and December 31, 2012, the carrying value of our other assets and liabilities approximates their fair value due to their short-term nature. The following tables reconcile the beginning and ending balances of our Level 3 assets and liabilities as of June 30, 2013 and December 31, 2012:
The estimated fair values of our financial instruments have been determined by using available market information and what we believe to be appropriate valuation methodologies. We use the following methods and assumptions in estimating fair value: BZNE Notes and conversion feature - The stock market activity in BZNE does not represent an active market and as such, we determined the fair market value utilizing a business enterprise valuation approach in order to determine the fair value of our investment. The most significant assumptions are the projected revenue growth and operating income (loss). The impact of a change in any of our significant underlying assumptions +/-1% would not result in a materially different fair value. Contingent consideration – We estimate the fair value of the contingent consideration utilizing a discounted cash flow model for the expected payments based on estimated timing and expected revenues. We use several discount rates depending on each type of contingent consideration related to FineTech, OPKO Diagnostics, CURNA, Farmadiet and Cytochroma transactions. The discount rates used range from 6% to 27% and were based on the weighted average cost of capital for those businesses. If the discount rates were to increase by 1%, on each transaction, the contingent consideration would decrease by $1.3 million. If estimated future sales were to decrease by 10%, the contingent consideration related to CURNA, FineTech and Cytochroma would decrease by $0.5 million. As of June 30, 2013, of the $68.9 million of contingent consideration, $5.3 million is recorded in Accrued expenses and $63.6 million is recorded in Other long-term liabilities. As of December 31, 2012, of the $20.0 million of contingent consideration, $5.1 million is recorded in Accrued expenses and $14.9 million is recorded in Other long-term liabilities. Deferred payments – We estimate the fair value of the deferred payments utilizing a discounted cash flow model for the expected payments. Embedded conversion option – We estimate the fair value of the embedded conversion option related to the Notes using a binomial lattice model. Refer to Note 6 for detail description of the binomial lattice model and the fair value assumptions used. Pharmsynthez Note Receivable and Purchase Option - We determined the fair value of the Pharmsynthez Note Receivable and Purchase Option using a number of Black-Scholes scenarios simulating changes in Pharmsynthez's common stock price. Refer to Note 8. |
Derivative Contracts (Details) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2013
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Dec. 31, 2012
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Pharmsynthez [Member]
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Derivative financial instruments: | ||||||
Derivative asset, fair value | $ 6,795 | $ 0 | ||||
Neovasc common stock options/warrants [Member]
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Derivative financial instruments: | ||||||
Derivative asset, fair value | 2,319 | 1,872 | ||||
Embedded conversion option [Member]
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Derivative financial instruments: | ||||||
Derivative liability, fair value | 74,079 | 0 | ||||
Forward contracts [Member]
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Derivative financial instruments: | ||||||
Derivative liability, fair value | $ 2,242 | [1] | $ 1,294 | [1] | ||
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Condensed Consolidated Statements of Operations (Unaudited) (USD $)
In Thousands, except Share data, unless otherwise specified |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2013
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Jun. 30, 2012
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Jun. 30, 2013
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Jun. 30, 2012
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Revenues: | ||||
Products | $ 18,618 | $ 9,917 | $ 34,145 | $ 18,556 |
Revenue from services | 3,188 | 145 | 6,280 | 232 |
Revenue from transfer of intellectual property | 2,015 | 149 | 14,772 | 200 |
Total revenues | 23,821 | 10,211 | 55,197 | 18,988 |
Costs and expenses: | ||||
Costs of revenues | 13,103 | 6,554 | 24,860 | 11,541 |
Selling, general and administrative | 13,879 | 5,435 | 26,303 | 10,106 |
Research and development | 9,557 | 4,490 | 19,467 | 9,321 |
Contingent consideration | 2,577 | 965 | 3,921 | 2,109 |
Amortization of intangible assets | 2,688 | 2,108 | 5,402 | 4,099 |
Total costs and expenses | 41,804 | 19,552 | 79,953 | 37,176 |
Loss from operations | (17,983) | (9,341) | (24,756) | (18,188) |
Other income and (expense), net: | ||||
Interest income | 90 | 47 | 149 | 74 |
Interest expense | (3,842) | (231) | (6,739) | (582) |
Fair value changes of derivative instruments, net | 12,651 | 23 | (10,898) | 1,140 |
Other income (expense), net | 8,027 | (266) | 10,358 | (85) |
Other income and (expense), net | 16,926 | (427) | (7,130) | 547 |
Loss before income taxes and investment losses | (1,057) | (9,768) | (31,886) | (17,641) |
Income tax provision | 925 | 2 | 968 | 217 |
Loss before investment losses | (1,982) | (9,770) | (32,854) | (17,858) |
Loss from investments in investees | (2,371) | (475) | (6,261) | (996) |
Net loss | (4,353) | (10,245) | (39,115) | (18,854) |
Less: Net loss attributable to noncontrolling interests | (959) | 0 | (1,506) | 0 |
Net loss attributable to common shareholders before preferred stock dividend | (3,394) | (10,245) | (37,609) | (18,854) |
Preferred stock dividend | 0 | (560) | (420) | (1,120) |
Net loss attributable to common shareholders | $ (3,394) | $ (10,805) | $ (38,029) | $ (19,974) |
Basic and diluted loss per share (in dollars per share) | $ (0.01) | $ (0.04) | $ (0.12) | $ (0.07) |
Weighted average number of common shares outstanding, basic and diluted (in shares) | 336,732,215 | 297,836,707 | 324,898,133 | 297,689,886 |
Business and Organization
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6 Months Ended |
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Jun. 30, 2013
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BUSINESS AND ORGANIZATION | BUSINESS AND ORGANIZATION We are a multi-national biopharmaceutical 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. We are developing a range of solutions to diagnose, treat and prevent various conditions, including molecular diagnostics tests, laboratory developed tests, point-of-care tests, and proprietary pharmaceuticals and vaccines. We plan to commercialize these solutions on a global basis in large and high growth markets, including emerging markets. We own established pharmaceutical platforms in Spain, Chile and Mexico, which are generating revenue and which we expect to generate positive cash flow and facilitate future market entry for our products currently in development. In addition, we recently established pharmaceutical operations in Brazil. We also operate a specialty active pharmaceutical ingredients (“APIs”) manufacturer in Israel, which we expect to play a valuable role in the development of our pipeline of molecules and compounds for our proprietary molecular diagnostic and therapeutic products. We operate a laboratory business with laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), that has a strong presence in the U.S. urologic pathology market, and will provide us with a platform to commercialize certain of our novel diagnostics tests currently in development. We also own an interest in a biopharmaceutical company that develops, manufactures and markets recombinant human health care biotechnology derived products in Israel and whose principal marketed product is a novel third generation Hepatitis B vaccine currently being commercialized in Israel, India and Hong Kong. We are incorporated in Delaware and our principal executive offices are located in leased offices in Miami, Florida. We lease office and lab space in Jupiter and Miramar, Florida, which is where our molecular diagnostics research and development and oligonucleotide research and development operations are based, respectively. We lease office, manufacturing and warehouse space in Woburn, Massachusetts for our point-of-care diagnostics business, and in Nesher, Israel for our API business. We lease laboratory and office space in Nashville, Tennessee and Burlingame, California for our CLIA-certified laboratory business, and we lease office space in Bannockburn, Illinois, and Markham, Ontario and laboratory space in Toronto, Ontario for our pharmaceutical business directed to chronic kidney disease. Our Chilean operations are located in leased offices and warehouse facilities in Santiago. Our Mexican operations are based in owned offices, an owned manufacturing facility and a leased warehouse facility in Guadalajara and in leased offices in Mexico City. Our Spanish operations are based in owned offices in Barcelona, in an owned manufacturing facility in Banyoles and a leased warehouse facility in Palol de Revardit. Our Brazilian operations are located in leased offices in Sao Paulo. |
Summary of Significant Accounting Policies (Policies)
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6 Months Ended |
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Jun. 30, 2013
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Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation. The accompanying unaudited 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 six months ended June 30, 2013, are not necessarily indicative of the results of operations and cash flows that may be reported for the remainder of 2013 or for future periods. The unaudited condensed consolidated financial statements should be read in conjunction with the Consolidated Financial Statements and the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2012. |
Reclassifications | Reclassifications. Certain prior year amounts in the condensed consolidated financial statements have been reclassified to conform with the 2013 presentation. Due to the acquisition of OPKO OURLab, LLC (formerly Prost-Data, Inc.), our CLIA-certified laboratory business (“OURLab”) in December 2012, we changed our segment presentation to include diagnostics as a reportable segment. As a result of this change in reportable segments, we restated certain prior year amounts in the condensed consolidated financial statements to conform with the 2013 presentation. These reclassifications had no impact on our results of operations. |
Principles of consolidation | Principles of consolidation. The accompanying unaudited condensed consolidated financial statements include the accounts of OPKO Health, Inc., our wholly-owned subsidiaries and variable interest entities (“VIEs”) in which we are deemed to be the primary beneficiary. All significant intercompany accounts and transactions are eliminated in consolidation. |
Use of estimates | Use of estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the United States 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. Cash and cash equivalents include 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, certificates of deposit and U.S. treasury securities. |
Inventories | Inventories. Inventories are valued at the lower of cost or market (net realizable value). Cost is determined by the first-in, first-out method. We consider such factors as the amount of inventory on hand, estimated time required to sell such inventories, remaining shelf-life, and current market conditions to determine whether inventories are stated at the lower of cost or market. |
Goodwill and Intangible Assets | Goodwill and Intangible Assets. Goodwill represents the difference between the purchase price and the estimated fair value of the net assets acquired when accounted for by the purchase method of accounting and arose from our acquisitions. Goodwill and other intangible assets acquired in business combinations, licensing and other transactions at June 30, 2013 and December 31, 2012 were $364.9 million and $176.2 million, respectively. Assets acquired and liabilities assumed in business combinations, licensing and other transactions are recognized at the date of acquisition at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recognized as goodwill. We determined the fair value of intangible assets, including in-process research and development (“IPR&D”), using the “income method.” Goodwill is tested at least annually for impairment, or when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable, on an enterprise level by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that its fair value exceeds the carrying value. |
Fair value measurements | Fair value measurements. The carrying amounts of our cash and cash equivalents, accounts receivable and accounts payable approximate their fair value due to the short-term maturities of these instruments. Investments that are considered available for sale as of June 30, 2013 are carried at fair value. Short-term investments, which we invest in from time to time, include bank deposits, corporate notes, U.S. treasury securities and U.S. government agency securities with original maturities of greater than 90 days and remaining maturities of less than one year. Long-term investments include corporate notes, U.S. treasury securities and U.S. government agency securities with maturities greater than one year. In evaluating the fair value information, considerable judgment is required to interpret the market data used to develop the estimates. The use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts. Accordingly, the estimates of fair value presented herein may not be indicative of the amounts that could be realized in a current market exchange. |
Contingent consideration | Contingent consideration. Each period we revalue the contingent consideration obligations associated with certain acquisitions to their fair value and record increases in the fair value as contingent consideration expense and decreases in the fair value as contingent consideration income. Changes in contingent consideration result from changes in the assumptions regarding probabilities of successful achievement of related milestones, the estimated timing in which the milestones are achieved and the discount rate used to estimate the fair value of the liability. Contingent consideration may change significantly as our development programs progress, revenue estimates evolve and additional data is obtained, impacting our assumptions. The assumptions used in estimating fair value require significant judgment. The use of different assumptions and judgments could result in a materially different estimate of fair value which may have a material impact on our results from operations and financial position. |
Derivative financial instruments | Derivative financial instruments. We record derivative financial instruments on our Condensed Consolidated Balance Sheet at their fair value and recognize the changes in the fair value in our Condensed Consolidated Statement of Operations, when they occur, the only exception being derivatives that qualify as hedges. For the derivative instrument to qualify 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, 2013 and December 31, 2012, our forward contracts for inventory purchases did not meet the documentation requirements to be designated as hedges. Accordingly, we recognize all changes in the fair values of our derivatives instruments in Fair value changes of derivatives instruments, net, in our Condensed Consolidated Statement of Operations. |
Revenue recognition | Revenue recognition. Generally, we recognize revenue from product sales when goods are shipped and title and risk of loss transfer to our customers. Our estimates for sales returns and allowances are based upon the historical patterns of product returns and allowances taken, matched against the sales from which they originated, and management’s evaluation of specific factors that may increase or decrease the risk of product returns. Revenue for services is recognized on the accrual basis at the time test results are reported, which approximates when services are provided. Services are provided to certain patients covered by various third-party payer programs including various managed care organizations, as well as the Medicare and Medicaid programs. Billings for services under third-party payer programs are included in sales net of allowances for contractual discounts and allowances for differences between the amounts billed and estimated program payment amounts. Adjustments to the estimated payment amounts based on final settlement with the programs are recorded upon settlement as an adjustment to revenue. For the three and six months ended June 30, 2013, revenue from services also includes $0.2 million and $0.4 million, respectively, of revenue related to our consulting agreement with Neovasc, Inc. (“Neovasc”) and to revenue related to molecular diagnostics collaboration agreements. For the three and six months ended June 30, 2012, revenue from services included $0.1 million and $0.2 million, respectively, of revenue related to our consulting agreement with Neovasc and to revenue related to molecular diagnostics collaboration agreements. We recognize this revenue on a straight-line basis over the contractual term of the agreements. Revenue from transfer of intellectual property includes revenue related to the sale, license or transfer of intellectual property such as 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, included in Accrued expenses or Other long-term liabilities, when 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. The 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. For the six months ended June 30, 2013, we recorded $14.8 million of revenue from the transfer of intellectual property, of which $12.5 million related to the sale of substantially all of our assets in the field of RNA interference to RXi Pharmaceuticals Corporation (“RXi”) during the first quarter of 2013. Refer to Note 5. Revenue from milestone payments related to arrangements under which we have continuing performance obligations are recognized as Revenue from transfer of intellectual property 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 from transfer of intellectual property over the term of the arrangement as we complete our performance obligations. |
Allowance for doubtful accounts | 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. |
Equity-based compensation | 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. |
Segment reporting | 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. We currently manage our operations in two reportable segments, pharmaceuticals and diagnostics. The pharmaceuticals segment consists of two operating segments, our (i) pharmaceutical research and development segment which is focused on the research and development of pharmaceutical products and vaccines, and (ii) the pharmaceutical operations we acquired in Chile, Mexico, Israel, Spain and Brazil. The diagnostics segment consists of two operating segments, our (i) pathology operations we acquired through the acquisition of OURLab and (ii) point-of-care and molecular diagnostics operations. 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. |
Variable interest entities | Variable interest entities. The consolidation of VIEs is required when an enterprise has a controlling financial interest. A controlling financial interest in a VIE will have both of the following characteristics: (a) the power to direct the activities of a VIE that most significantly impact the VIE’s economic performance and (b) the obligation to absorb losses of the VIE that could potentially be significant to the VIE. |
Investments | Investments. We have made strategic investments in development stage and emerging companies. We record these investments as equity method investments or investments available for sale based on our percentage of ownership and whether we have significant influence over the operations of the investees. For investments classified under the equity method of accounting, we record our proportionate share of their losses in Losses from investments in investees in our Condensed Consolidated Statement of Operations. Refer to Note 5. For investments classified as available for sale, we record changes in their fair value as unrealized gain or loss in Other comprehensive loss based on their closing price per share at the end of each reporting period. |
Recent accounting pronouncements | Recent accounting pronouncements. In February 2013, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2013-2, Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income, (“ASU 2013-2”). ASU 2013-2 requires the presentation of reclassifications out of accumulated other comprehensive income in either (1)the notes or (2)the face of the financial statements. We adopted ASU 2013-2 for our first quarter ended March 31, 2013. The adoption of ASU 2013-2 did not have a material impact in our condensed consolidated financial statements, but did require certain additional disclosures. |
Derivative Contracts (Details Textual)
|
Jun. 30, 2013
|
Jan. 30, 2013
|
Dec. 31, 2012
|
---|---|---|---|
Derivative Contracts (Textual) [Abstract] | |||
Convertible senior notes interest rate | 3.00% | 3.00% | 3.00% |
Derivative Contracts
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2013
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DERIVATIVE CONTRACTS | 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. The following table summarizes the fair values and the presentation of our derivative financial instruments in the Condensed Consolidated Balance Sheets:
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, 2013 and December 31, 2012, our derivative financial instruments do not meet the documentation requirements to be designated as hedges. Accordingly, we recognize the changes in fair value in Fair value changes of derivative instruments, net in our Condensed Consolidated Statements of Operations. The following table summarizes the (losses) and gains recorded during the three and six months ended June 30, 2013 and 2012:
The outstanding forward contracts at June 30, 2013 and December 31, 2012, have been recorded at fair value, and their maturity details are as follows:
|
Related Party Transactions (Details) (USD $)
|
1 Months Ended | 3 Months Ended | 6 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | 0 Months Ended | 1 Months Ended | 6 Months Ended | 1 Months Ended | 6 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | ||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Feb. 29, 2012
|
Jun. 30, 2010
|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jan. 31, 2013
|
Jan. 30, 2013
|
Dec. 31, 2012
|
Sep. 30, 2009
Installment
|
Sep. 21, 2009
|
Feb. 29, 2012
Chromadex Corporation [Member]
|
Feb. 29, 2012
Biozone Pharmaceuticals Inc [Member]
|
Jun. 30, 2012
Biozone Pharmaceuticals Inc [Member]
|
Apr. 30, 2012
Biozone Pharmaceuticals Inc [Member]
|
Sep. 21, 2011
Biozone Pharmaceuticals Inc [Member]
|
May 16, 2011
Biozone Pharmaceuticals Inc [Member]
|
Dec. 31, 2012
Teva [Member]
|
Aug. 31, 2011
Dr. Hsiao [Member]
|
Sep. 21, 2011
Dr. Hsiao [Member]
Aero Pharmaceuticals Inc [Member]
|
Sep. 21, 2011
Dr. Hsiao [Member]
Biozone Pharmaceuticals Inc [Member]
|
Aug. 31, 2011
Mr. Rubin [Member]
|
Sep. 21, 2011
Mr. Rubin [Member]
Biozone Pharmaceuticals Inc [Member]
|
Feb. 29, 2012
Gamma Trust [Member]
|
Feb. 29, 2012
Hsu Gamma [Member]
|
Jun. 30, 2009
Sorrento [Member]
|
Jun. 10, 2009
Sorrento [Member]
|
Nov. 30, 2007
Real Estate Holdings LLC [Member]
sqft
|
Jun. 30, 2013
Real Estate Holdings LLC [Member]
|
Nov. 30, 2010
Fabrus Inc [Member]
|
Aug. 31, 2011
Dr. Frost [Member]
|
Sep. 21, 2011
Dr. Frost [Member]
Aero Pharmaceuticals Inc [Member]
|
Sep. 21, 2011
Dr. Frost [Member]
Biozone Pharmaceuticals Inc [Member]
|
Sep. 21, 2011
Mr. Prego Novo [Member]
Aero Pharmaceuticals Inc [Member]
|
Sep. 21, 2011
Mr. Prego Novo [Member]
Biozone Pharmaceuticals Inc [Member]
|
Jun. 30, 2013
Dr. Lerner [Member]
|
Feb. 29, 2012
Dr. Lerner [Member]
Chromadex Corporation [Member]
|
Dec. 31, 2012
Avi Properties LLC [Member]
sqft
|
Dec. 31, 2012
Avi Properties LLC [Member]
sqft
|
Feb. 29, 2012
Scripps Research Institute [Member]
|
|
Related Party Transactions (Textual) [Abstract] | ||||||||||||||||||||||||||||||||||||||||
Period of lease | 5 years | |||||||||||||||||||||||||||||||||||||||
Square feet of laboratory | 44,000 | 44,000 | ||||||||||||||||||||||||||||||||||||||
Payments of lease per month | $ 18,000 | |||||||||||||||||||||||||||||||||||||||
Exceeds consumer price index | 5.00% | |||||||||||||||||||||||||||||||||||||||
Sale of API to TEVA | 23,821,000 | 10,211,000 | 55,197,000 | 18,988,000 | 100,000 | |||||||||||||||||||||||||||||||||||
Approximate funding for development of technology | 200,000 | |||||||||||||||||||||||||||||||||||||||
Period for development of technology | 3 years | |||||||||||||||||||||||||||||||||||||||
Invested in common shares | 1,000,000 | 2,300,000 | ||||||||||||||||||||||||||||||||||||||
Beneficially owned held by members | 1.50% | 6.00% | 16.00% | 1.00% | 36.00% | |||||||||||||||||||||||||||||||||||
Ownership Percentage Held | less than 1% | less than 1% | less than one percent | less than 1% | ||||||||||||||||||||||||||||||||||||
Sales | 1,700,000 | |||||||||||||||||||||||||||||||||||||||
Convertible senior notes interest rate | 3.00% | 3.00% | 3.00% | 3.00% | 10.00% | |||||||||||||||||||||||||||||||||||
Par value | $ 0.20 | |||||||||||||||||||||||||||||||||||||||
Promissory notes maturity date | Feb. 24, 2014 | |||||||||||||||||||||||||||||||||||||||
Warrants duration | 10 years | |||||||||||||||||||||||||||||||||||||||
Warrants to purchase Common shares | 8,500,000 | |||||||||||||||||||||||||||||||||||||||
Exercise price per share | $ 0.40 | |||||||||||||||||||||||||||||||||||||||
Issue of common stock / Issue of common stock against acquisition | 339,045,029 | 339,045,029 | 305,560,763 | 13,914 | 8,331,396 | |||||||||||||||||||||||||||||||||||
Equity Method Investment, Ownership Percentage | 12.00% | 1.70% | 1.00% | 46.00% | 9.20% | 23.00% | 8.20% | |||||||||||||||||||||||||||||||||
Loan to bzne | 100,000 | 300,000 | ||||||||||||||||||||||||||||||||||||||
Maximum beneficially owned by members (less than 1%) | 1.00% | 1.00% | 1.00% | |||||||||||||||||||||||||||||||||||||
Outstanding membership interests on a fully diluted basis | 13.00% | |||||||||||||||||||||||||||||||||||||||
Investment was part of financing for Fabrus | 2,100,000 | |||||||||||||||||||||||||||||||||||||||
Ownership percentage held by director | 5.00% | |||||||||||||||||||||||||||||||||||||||
Outstanding common shares of Sorrento acquired | 0.33 | |||||||||||||||||||||||||||||||||||||||
Lease space in office building having principal office | 8,300 | |||||||||||||||||||||||||||||||||||||||
Lease rent per month for first year | 18,000 | |||||||||||||||||||||||||||||||||||||||
Lease rent per month for fifth year | 24,000 | |||||||||||||||||||||||||||||||||||||||
Credit for tenant improvements | 30,000 | |||||||||||||||||||||||||||||||||||||||
Period of lease agreement | 6 months | |||||||||||||||||||||||||||||||||||||||
Related Party Transactions (Additional Textual) [Abstract] | ||||||||||||||||||||||||||||||||||||||||
Convertible senior notes | 175,000,000.0 | |||||||||||||||||||||||||||||||||||||||
Fund for research agreement | 900,000 | |||||||||||||||||||||||||||||||||||||||
Research agreement maturity period | 5 years | |||||||||||||||||||||||||||||||||||||||
Research and development agreement amount | 200,000 | |||||||||||||||||||||||||||||||||||||||
Agreement pursuant to which invested Cocrystal | 2,500,000 | |||||||||||||||||||||||||||||||||||||||
Number of convertible series preferred stock held from agreement | 1,701,723 | |||||||||||||||||||||||||||||||||||||||
Previous investment by a group of investor | 5,000,000 | |||||||||||||||||||||||||||||||||||||||
Additional investment by a group of investor | 5,000,000 | |||||||||||||||||||||||||||||||||||||||
Number of equal installments payable for additional investment | 2 | |||||||||||||||||||||||||||||||||||||||
First installment investment | 2,500,000 | |||||||||||||||||||||||||||||||||||||||
Reimbursement paid to related party for travel | $ 5,000 | $ 65,000 | $ 18,000 | $ 129,000 |
Acquisitions, Investments, and Licenses (Details 3) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2013
|
Dec. 31, 2012
|
Jun. 30, 2012
|
Dec. 31, 2011
|
||||
---|---|---|---|---|---|---|---|---|
Current assets: | ||||||||
Cash and cash equivalents | $ 119,061 | [1] | $ 27,361 | [1] | $ 38,171 | $ 71,516 | ||
Accounts receivable, net | 22,227 | [1] | 21,162 | [1] | ||||
Inventory, net | 19,778 | [1] | 22,261 | [1] | ||||
Prepaid expenses and other current assets | 19,023 | [1] | 7,873 | [1] | ||||
Total current assets | 230,116 | [1] | 78,657 | [1] | ||||
Property, plant and equipment, net | 16,577 | [1] | 16,526 | [1] | ||||
Intangible assets, net | 79,775 | [1] | 84,238 | [1] | ||||
Goodwill | 82,086 | [1] | 80,450 | [1] | ||||
Other assets | 2,784 | [1] | 2,777 | [1] | ||||
Total assets | 641,080 | [1] | 289,830 | [1] | ||||
Current liabilities: | ||||||||
Accounts payable | 11,646 | [1] | 10,200 | [1] | ||||
Accrued expenses | 31,045 | [1] | 24,656 | [1] | ||||
Total current liabilities | 59,469 | [1] | 52,382 | [1] | ||||
Other long-term liabilities | 80,603 | [1] | 34,168 | [1] | ||||
Total liabilities | 328,596 | [1] | 86,550 | [1] | ||||
SciVac [Member]
|
||||||||
Current assets: | ||||||||
Cash and cash equivalents | 363 | 174 | ||||||
Accounts receivable, net | 266 | 387 | ||||||
Inventory, net | 1,573 | 1,092 | ||||||
Prepaid expenses and other current assets | 132 | 199 | ||||||
Total current assets | 2,334 | 1,852 | ||||||
Property, plant and equipment, net | 1,425 | 1,539 | ||||||
Intangible assets, net | 1,128 | 1,154 | ||||||
Goodwill | 822 | 796 | ||||||
Other assets | 298 | 231 | ||||||
Total assets | 6,007 | 5,572 | ||||||
Current liabilities: | ||||||||
Accounts payable | 1,254 | 1,108 | ||||||
Accrued expenses | 5,157 | 2,859 | ||||||
Notes payable | 1,132 | 0 | ||||||
Total current liabilities | 7,543 | 3,967 | ||||||
Other long-term liabilities | 282 | 1,529 | ||||||
Total liabilities | $ 7,825 | $ 5,496 | ||||||
|
Debt (Tables)
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2013
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inputs to lattice model used to value the embedded derivative | The following table sets forth the inputs to the lattice model used to value the embedded derivative:
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Fair value of notes with and without the embedded derivatives and fair value of embedded derivatives | The following table sets forth the fair value of the Notes with and without the embedded derivatives, and the fair value of the embedded derivatives as of the issuance date and June 30, 2013:
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Schedule of principal amounts, unamortized discount and net carrying amounts | The principal amounts, unamortized discount and net carrying amounts of the Notes as of June 30, 2013 were as follows:
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Summary of lines of credit | The following table summarizes the amount outstanding under the lines of credit:
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Mortgage notes and other debt payables | At June 30, 2013 and December 31, 2012, we had mortgage notes and other debt payables related to Farmadiet as follows:
|
Acquisitions, Investments, and Licenses (Tables)
|
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2013
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Business Acquisition [Line Items] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pro Forma Result of Combined Companies | The following table includes the pro forma results for the three and six months ended June 30, 2013 and 2012 of the combined companies as though the acquisition of Cytochroma had been completed as of the beginning of each period, respectively.
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Maximum exposure of unconsolidated investments | The following table reflects our maximum exposure, accounting method, ownership interest and underlying equity in net assets of each of our unconsolidated investments as of June 30, 2013:
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Cytochroma acquisition [Member]
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Business Acquisition [Line Items] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Estimated fair value of the net assets acquired and liabilities assumed in the acquisition of at the date of acquisition | The following table summarizes the estimated fair value of the net assets acquired and liabilities assumed in the acquisition of Cytochroma at the date of acquisition, which are subject to change while contingencies that existed on the acquisition date are resolved:
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SciVac [Member]
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Business Acquisition [Line Items] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of consolidated assets and non-recourse liabilities related to SciVac | The following table represents the consolidated assets and non-recourse liabilities related to SciVac as of June 30, 2013 and December 31, 2012. These assets are owned by, and these liabilities are obligations of, SciVac, not us.
|
Composition of Certain Financial Statement Captions (Details) (USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2013
|
Dec. 31, 2012
|
||||
---|---|---|---|---|---|---|
Accounts receivable, net: | ||||||
Accounts receivable | $ 23,135 | $ 21,636 | ||||
Less: allowance for doubtful accounts | (908) | (474) | ||||
Accounts receivable, net | 22,227 | [1] | 21,162 | [1] | ||
Inventories, net: | ||||||
Finished products | 15,169 | 17,963 | ||||
Work in-process | 1,253 | 688 | ||||
Raw materials | 4,721 | 4,923 | ||||
Less: inventory reserve | (1,365) | (1,313) | ||||
Inventory, net | 19,778 | [1] | 22,261 | [1] | ||
Intangible assets, net: | ||||||
Technologies | 52,796 | 52,810 | ||||
Customer relationships | 22,839 | 23,088 | ||||
Product registrations | 9,690 | 9,637 | ||||
Tradenames | 3,683 | 3,746 | ||||
Covenants not to compete | 8,660 | 8,662 | ||||
Other | 1,180 | 367 | ||||
Less: accumulated amortization | (19,073) | (14,072) | ||||
Intangible assets, net | 79,775 | 84,238 | ||||
Accrued expenses: | ||||||
Income taxes payable | 2,421 | 1,614 | ||||
Deferred revenue | 3,903 | 1,518 | ||||
Clinical trials | 315 | 50 | ||||
Professional fees | 933 | 675 | ||||
Employee benefits | 3,972 | 3,319 | ||||
Deferred acquisition payments, net of discount | 5,432 | 6,172 | ||||
Contingent consideration | 5,298 | 5,126 | ||||
Interest payable related to the Notes | 2,275 | 0 | ||||
Other | 6,496 | 6,182 | ||||
Accrued expenses | 31,045 | 24,656 | ||||
Other long-term liabilities: | ||||||
Deferred acquisition payments, net of discount | 3,983 | 3,931 | ||||
Mortgages and other debts payable | 3,636 | 5,150 | ||||
Deferred tax liabilities | 7,185 | 9,777 | ||||
Other, including deferred revenue | 2,191 | 380 | ||||
Other long-term liabilities | 80,603 | [1] | 34,168 | [1] | ||
Cytochroma [Member]
|
||||||
Other long-term liabilities: | ||||||
Contingent consideration | 49,784 | 0 | ||||
Farmadiet [Member]
|
||||||
Other long-term liabilities: | ||||||
Contingent consideration | 529 | 532 | ||||
OPKO Diagnostics [Member]
|
||||||
Other long-term liabilities: | ||||||
Contingent consideration | 12,746 | 11,310 | ||||
FineTech [Member]
|
||||||
Other long-term liabilities: | ||||||
Contingent consideration | 0 | 2,578 | ||||
CURNA [Member]
|
||||||
Other long-term liabilities: | ||||||
Contingent consideration | $ 549 | $ 510 | ||||
|
Debt (Details) (USD $)
|
1 Months Ended | 6 Months Ended |
---|---|---|
Jan. 30, 2013
Rate
|
Jun. 30, 2013
Rate
|
|
Inputs to lattice model used to value the embedded derivative | ||
Stock price | $ 6.20 | $ 7.10 |
Conversion Rate | 141.4827 | 141.4827 |
Conversion Price | $ 7.07 | $ 7.07 |
Maturity date | Feb. 01, 2033 | Feb. 01, 2033 |
Risk-free interest rate | 1.12% | 1.57% |
Estimated stock volatility | 40.00% | 35.00% |
Estimated credit spread | 9.44% | 9.83% |
Fair Value Measurements (Details 1) (Fair Value, Measurements, Recurring [Member], USD $)
In Thousands, unless otherwise specified |
Jun. 30, 2013
|
Dec. 31, 2012
|
---|---|---|
Assets: | ||
Total assets | $ 169,859 | $ 31,684 |
Liabilities: | ||
Total liabilities | 152,400 | 30,169 |
Common stock investments, available for sale [Member]
|
||
Assets: | ||
Total assets | 2,536 | 8,236 |
Level 1 [Member]
|
||
Assets: | ||
Total assets | 107,718 | 26,952 |
Level 1 [Member] | Common stock investments, available for sale [Member]
|
||
Assets: | ||
Total assets | 2,536 | 8,236 |
Level 2 [Member]
|
||
Assets: | ||
Total assets | 60,101 | 2,692 |
Liabilities: | ||
Total liabilities | 0 | 10 |
Level 3 [Member]
|
||
Assets: | ||
Total assets | 2,040 | 2,040 |
Liabilities: | ||
Total liabilities | 152,400 | 30,159 |
Forward contracts [Member]
|
||
Liabilities: | ||
Total liabilities | 10 | |
Forward contracts [Member] | Level 2 [Member]
|
||
Liabilities: | ||
Total liabilities | 10 | |
Embedded conversion option [Member]
|
||
Liabilities: | ||
Total liabilities | 74,079 | |
Embedded conversion option [Member] | Level 3 [Member]
|
||
Liabilities: | ||
Total liabilities | 74,079 | |
Deferred acquisition payments, net of discount [Member]
|
||
Liabilities: | ||
Total liabilities | 9,415 | 10,103 |
Deferred acquisition payments, net of discount [Member] | Level 3 [Member]
|
||
Liabilities: | ||
Total liabilities | 9,415 | 10,103 |
CURNA [Member]
|
||
Liabilities: | ||
Total liabilities | 549 | 510 |
CURNA [Member] | Level 3 [Member]
|
||
Liabilities: | ||
Total liabilities | 549 | 510 |
OPKO Diagnostics [Member]
|
||
Liabilities: | ||
Total liabilities | 14,512 | 12,974 |
OPKO Diagnostics [Member] | Level 3 [Member]
|
||
Liabilities: | ||
Total liabilities | 14,512 | 12,974 |
FineTech [Member]
|
||
Liabilities: | ||
Total liabilities | 2,763 | 5,262 |
FineTech [Member] | Level 3 [Member]
|
||
Liabilities: | ||
Total liabilities | 2,763 | 5,262 |
Cytochroma [Member]
|
||
Liabilities: | ||
Total liabilities | 49,784 | |
Cytochroma [Member] | Level 3 [Member]
|
||
Liabilities: | ||
Total liabilities | 49,784 | |
Farmadiet [Member]
|
||
Liabilities: | ||
Total liabilities | 1,298 | 1,310 |
Farmadiet [Member] | Level 3 [Member]
|
||
Liabilities: | ||
Total liabilities | 1,298 | 1,310 |
Money market funds [Member]
|
||
Assets: | ||
Total assets | 80,183 | 18,716 |
Money market funds [Member] | Level 1 [Member]
|
||
Assets: | ||
Total assets | 80,183 | 18,716 |
US Treasury Securities [Member]
|
||
Assets: | ||
Total assets | 75,026 | |
US Treasury Securities [Member] | Level 1 [Member]
|
||
Assets: | ||
Total assets | 24,999 | |
US Treasury Securities [Member] | Level 2 [Member]
|
||
Assets: | ||
Total assets | 50,027 | |
Certificates of Deposit [Member]
|
||
Assets: | ||
Total assets | 827 | 820 |
Certificates of Deposit [Member] | Level 2 [Member]
|
||
Assets: | ||
Total assets | 827 | 820 |
Forward Contracts [Member]
|
||
Assets: | ||
Total assets | 133 | |
Forward Contracts [Member] | Level 2 [Member]
|
||
Assets: | ||
Total assets | 133 | |
Neovasc common stock options [Member]
|
||
Assets: | ||
Total assets | 2,319 | 1,394 |
Neovasc common stock options [Member] | Level 2 [Member]
|
||
Assets: | ||
Total assets | 2,319 | 1,394 |
Current portion of lines of credit and notes payable [Member] | BZNE Note and conversion feature [Member]
|
||
Assets: | ||
Total assets | 2,040 | 2,040 |
Current portion of lines of credit and notes payable [Member] | Level 3 [Member] | BZNE Note and conversion feature [Member]
|
||
Assets: | ||
Total assets | 2,040 | 2,040 |
Warrant [Member]
|
||
Assets: | ||
Total assets | 478 | |
Warrant [Member] | Level 2 [Member]
|
||
Assets: | ||
Total assets | 478 | |
Notes Receivable [Member]
|
||
Assets: | ||
Total assets | 6,795 | |
Notes Receivable [Member] | Level 2 [Member]
|
||
Assets: | ||
Total assets | $ 6,795 |
Segments (Tables)
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2013
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Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Information regarding our geographic activities | Information regarding our operations and assets for our operating segments and the unallocated corporate operations as well as geographic information are as follows:
|
Debt (Details 3) (USD $)
In Thousands, unless otherwise specified |
6 Months Ended | |
---|---|---|
Jun. 30, 2013
|
Dec. 31, 2012
|
|
Summary of lines of credit | ||
Credit line capacity | $ 19,625 | |
Amount outstanding | 13,261 | 15,195 |
Itau Bank [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 6.66% | |
Credit line capacity | 3,000 | |
Amount outstanding | 2,664 | 2,738 |
Bank of Chile [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 7.50% | |
Credit line capacity | 3,000 | |
Amount outstanding | 2,237 | 2,292 |
BICE Bank [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 5.02% | |
Credit line capacity | 2,000 | |
Amount outstanding | 940 | 2,451 |
Corp Banca [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 5.00% | |
Credit line capacity | 1,000 | |
Amount outstanding | 140 | 1,248 |
BBVA Bank [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 5.55% | |
Credit line capacity | 3,000 | |
Amount outstanding | 1,949 | 2,823 |
Penta Bank [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 9.48% | |
Credit line capacity | 1,000 | |
Amount outstanding | 793 | 833 |
Security Bank [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 7.60% | |
Credit line capacity | 1,500 | |
Amount outstanding | 994 | 0 |
BCI [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 5.00% | |
Credit line capacity | 1,500 | |
Amount outstanding | 1,591 | 0 |
Estado Bank [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 5.99% | |
Credit line capacity | 2,000 | |
Amount outstanding | 1,851 | 1,963 |
Sabadell Bank [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 7.60% | |
Credit line capacity | 195 | |
Amount outstanding | 0 | 3 |
Bilbao Vizcaya Bank [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 4.90% | |
Credit line capacity | 390 | |
Amount outstanding | 91 | 377 |
Banco Popular [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 8.25% | |
Credit line capacity | 390 | |
Amount outstanding | 11 | 260 |
Santander Bank [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 6.00% | |
Credit line capacity | 195 | |
Amount outstanding | 0 | 0 |
Banesto [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 5.80% | |
Credit line capacity | 195 | |
Amount outstanding | 0 | 163 |
Banca March [Member]
|
||
Summary of lines of credit | ||
Interest rate on borrowings | 6.25% | |
Credit line capacity | 260 | |
Amount outstanding | $ 0 | $ 44 |
Composition of Certain Financial Statement Captions (Tables)
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2013
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Composition of certain financial statement captions |
|
Condensed Consolidated Statement of Equity (Unaudited) (USD $)
In Thousands, except Share data, unless otherwise specified |
Total
|
Silcon
|
Cytochroma
|
Common Stock
|
Common Stock
Silcon
|
Common Stock
Cytochroma
|
Treasury
|
Additional Paid-In Capital
|
Additional Paid-In Capital
Silcon
|
Additional Paid-In Capital
Cytochroma
|
Acumulated Other Comprehensive Income (Loss)
|
Accumulated Deficit
|
Noncontrolling Interests
|
Series D Preferred Stock
|
Series D Preferred Stock
Common Stock
|
Series D Preferred Stock
Additional Paid-In Capital
|
|||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Beginning balance (audited) at Dec. 31, 2012 | $ 178,894 | [1] | $ 3,056 | $ (7,457) | $ 565,201 | $ 7,356 | $ (388,770) | $ (492) | |||||||||||
Beginning balance (audited), shares at Dec. 31, 2012 | 305,560,763 | 2,293,056 | |||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||
Equity-based compensation expense | 7,003 | 7,003 | |||||||||||||||||
Exercise of Common Stock options | 928 | 4 | 924 | ||||||||||||||||
Exercise of Common Stock options, shares | 447,690 | ||||||||||||||||||
Exercise of Common Stock warrants | 591 | 12 | 579 | ||||||||||||||||
Exercise of Common Stock warrants, shares | 1,164,542 | ||||||||||||||||||
Series D Preferred Stock dividend | (3,015) | (3,015) | |||||||||||||||||
Conversion of Series D Preferred Stock | 24,386 | 24,386 | 113 | 24,273 | |||||||||||||||
Conversion of Series D Preferred Stock, shares | 11,290,320 | ||||||||||||||||||
Issuance of Common Stock in connection with acquisition | 436 | 146,902 | 1 | 205 | 435 | 146,697 | |||||||||||||
Issuance of Common Stock in connection with acquisition, shares | 64,684 | 20,517,030 | |||||||||||||||||
Net loss attributable to common shareholders before preferred stock dividend | (37,609) | (37,609) | |||||||||||||||||
Net loss attributable to noncontrolling interests | (1,506) | (1,506) | |||||||||||||||||
Other comprehensive loss | (4,526) | (4,526) | |||||||||||||||||
Ending balance (unaudited) at Jun. 30, 2013 | $ 312,484 | [1] | $ 3,391 | $ (7,457) | $ 742,097 | $ 2,830 | $ (426,379) | $ (1,998) | |||||||||||
Ending balance (unaudited), shares at Jun. 30, 2013 | 339,045,029 | 2,293,056 | |||||||||||||||||
|
Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $)
In Thousands, unless otherwise specified |
6 Months Ended | ||||
---|---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
||||
Cash flows from operating activities: | |||||
Net loss | $ (39,115) | $ (18,854) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Depreciation and amortization | 6,880 | 4,782 | |||
Non-cash interest on convertible senior notes | 3,120 | 0 | |||
Amortization of deferred financing costs | 343 | 0 | |||
Losses from investments in investees | 6,261 | 996 | |||
Equity-based compensation – employees and non-employees | 7,003 | 2,169 | |||
Provision for (recovery of) bad debts | 329 | (91) | |||
Provision for inventory obsolescence | 1,273 | 754 | |||
Revenue from receipt of equity | (12,620) | (102) | |||
Realized gain on investments available for sale | (10,821) | 0 | |||
Change in fair value of derivatives instruments | 10,898 | (1,140) | |||
Change in fair value of contingent consideration | 3,921 | 2,109 | |||
Deferred income tax benefit | (602) | 0 | |||
Changes in assets and liabilities of continuing operations, net of the effects of acquisitions: | |||||
Accounts receivable | (1,652) | (2,681) | |||
Inventory | 1,213 | (3,321) | |||
Prepaid expenses and other current assets | (2,572) | (1,318) | |||
Other assets | 97 | 11 | |||
Accounts payable | 333 | (796) | |||
Foreign currency measurement | 450 | (109) | |||
Accrued expenses | 4,591 | (87) | |||
Cash used in operating activities of continuing operations | (20,670) | (17,678) | |||
Cash used in operating activities of discontinued operations | 0 | (82) | |||
Net cash used in operating activities | (20,670) | (17,760) | |||
Cash flows from investing activities: | |||||
Investments in investees | (13,341) | (2,700) | |||
Proceeds from sale of investments available for sale | 11,496 | 0 | |||
Acquisition of businesses, net of cash | 78 | (2,173) | |||
Purchase of marketable securities | (50,027) | (17,117) | |||
Capital expenditures | (2,054) | (408) | |||
Net cash used in investing activities | (53,848) | (22,398) | |||
Cash flows from financing activities: | |||||
Issuance of 3.00% convertible senior notes, net, including related parties | 170,184 | 0 | |||
Payment of Series D dividends, including related parties | (3,015) | 0 | |||
Proceeds from the exercise of Common Stock options and warrants | 1,519 | 1,492 | |||
Borrowings on lines of credit | 15,354 | 21,553 | |||
Repayments of lines of credit and capital lease obligations | (17,718) | (16,288) | |||
Net cash provided by financing activities | 166,324 | 6,757 | |||
Effect of exchange rate on cash and cash equivalents | (106) | 56 | |||
Net increase (decrease) in cash and cash equivalents | 91,700 | (33,345) | |||
Cash and cash equivalents at beginning of period | 27,361 | [1] | 71,516 | ||
Cash and cash equivalents at end of period | 119,061 | [1] | 38,171 | ||
SUPPLEMENTAL INFORMATION | |||||
Interest paid | 318 | 341 | |||
Income taxes paid (refunded), net | 242 | (197) | |||
RXi common stock received | 21,052 | 432 | |||
Shares issued upon the conversion of: | |||||
Series D Preferred Stock | 24,386 | 0 | |||
Common Stock warrants, net exercised | 815 | 0 | |||
Cytochroma
|
|||||
Issuance of Common Stock to acquire: | |||||
Issuance of common stock to acquire | 146,902 | 0 | |||
OPKO Brazil
|
|||||
Issuance of Common Stock to acquire: | |||||
Issuance of common stock to acquire | 436 | 0 | |||
Rxi Pharmaceuticals Corporation [Member]
|
|||||
SUPPLEMENTAL INFORMATION | |||||
RXi common stock received | 12,500 | ||||
Pharmaceutical [Member]
|
|||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Depreciation and amortization | 3,397 | 3,025 | |||
SUPPLEMENTAL INFORMATION | |||||
RXi common stock received | $ 13,800 | $ 0 | |||
|
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