ACQUISITIONS, INVESTMENTS, AND LICENSES | ACQUISITIONS, INVESTMENTS AND LICENSES Pending Bio-Reference acquisition On June 3, 2015, we entered into an agreement and plan of merger pursuant to which we agreed to acquire Bio-Reference. Bio-Reference is the third largest full service clinical laboratory in the United States and is known for its innovative technological solutions and pioneering leadership in the areas of genomics and genetic sequencing. Under the terms of the merger agreement, which has been approved by the Boards of Directors of both companies, all holders of Bio-Reference common stock will receive 2.75 shares of OPKO common stock for each share of Bio-Reference common stock. Assuming a closing price of $16.74 per share of OPKO common stock, the transaction is valued at approximately $1.3 billion , or $46.04 per share of Bio-Reference common stock. We expect the transaction to be completed during the second half of 2015. Closing of the transaction is subject to approval of Bio-Reference’s shareholders and other customary conditions. Although we have entered into the merger agreement, there is no guarantee that the merger will be completed. EirGen Pharma Limited acquisition On May 5, 2015, we entered into a series of purchase agreements to acquire all of the issued and outstanding shares of EirGen, a specialty pharmaceutical company incorporated in Ireland focused on the development and commercial supply of high potency, high barrier to entry pharmaceutical products, for $133.8 million in the aggregate. We acquired the outstanding shares of EirGen for approximately $100.2 million in cash and delivered 2,420,487 shares of our Common Stock valued at approximately $33.6 million based on the closing price per share of our Common Stock as reported by the New York Stock Exchange on the closing date of the acquisition, $13.88 per share. The following table summarizes the preliminary purchase price allocation and the estimated fair value of the net assets acquired and liabilities assumed in the acquisition of EirGen at the date of acquisition. The purchase price allocation for EirGen is preliminary: (In thousands) EirGen Current assets (1) $ 11,795 Intangible assets: IPR&D assets 19,597 Customer relationships 34,155 Currently marketed products 3,919 Total intangible assets 57,671 Goodwill 66,823 Property, plant and equipment 8,117 Other assets 1,232 Accounts payable and other liabilities (6,254 ) Deferred tax liability (5,618 ) Total purchase price $ 133,766 (1) Current assets include cash, accounts receivable, inventory and other assets of $5.5 million , $2.7 million , $2.2 million and $1.4 million , respectively, related to the EirGen acquisition. The fair value of the accounts receivable equals the gross contractual amount at the date of acquisition. Goodwill from the acquisition of EirGen principally relates to intangible assets that do not qualify for separate recognition (for instance, EirGen’s assembled workforce), our expectation to develop and market new products, and the deferred tax liability generated as a result of this being a partial stock transaction. Goodwill is not tax deductible for income tax purposes and was assigned to the pharmaceuticals segment. Revenue and Net loss in the Condensed Consolidated Statement of Operations for the six months ended June 30, 2015 includes revenue and earnings (loss) of EirGen from the date of acquisition to June 30, 2015 of $2.3 million and $(0.8) million , respectively. Our IPR&D assets will not be amortized until the underlying development programs are completed. Upon obtaining regulatory approval, the IPR&D assets are then accounted for as finite-lived intangible assets and amortized on a straight-line basis over its estimated useful life. We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, currently ranging from 3 to 20 years. We recognized $0.5 million of acquisition related costs for the acquisition of EirGen that were expensed in the current period as a component of Selling, general and administrative expense. Pro forma disclosure for EirGen acquisition The following table includes the pro forma results for the three and six months ended June 30, 2015 and 2014 of the combined companies as though the acquisition of EirGen had been completed as of the beginning of the period presented. For the three months ended June 30, For the six months ended June 30, (In thousands) 2015 2014 2015 2014 Revenues $43,848 $25,659 $76,769 $50,185 Net loss (43,420) (28,356) (162,331) (75,879) Net loss attributable to common shareholders (42,945) (27,759) (160,931) (74,742) Basic and diluted net loss per share $(0.09) $(0.07) $(0.35) $(0.18) The unaudited pro forma financial information is presented for information purposes only. The unaudited pro forma financial information may not necessarily reflect our future results of operations or what the results of operations would have been had we owned and operated EirGen as of the beginning of the period presented. Inspiro Medical Ltd. acquisition On April 17, 2014, we entered into a stock purchase agreement to acquire 100% of the issued and outstanding share capital of Inspiro Medical Ltd. (“Inspiro”), an Israeli medical device company developing a new platform to deliver small molecule drugs such as corticosteroids and beta agonists and larger molecules to treat respiratory diseases. In connection with the transaction, we paid $1.5 million in cash and delivered 999,556 shares of our Common Stock valued at $8.6 million . Inspiro’s Inspiromatic™ is a “smart” easy-to-use dry powder inhaler with several advantages over existing devices. We anticipate that this innovative device will play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases. We recorded the transaction as an asset acquisition and recorded the assets and liabilities at fair value. As the asset had no alternative future use, we recorded $10.1 million of acquired in-process research and development expenses. We record expense for in-process research and development projects accounted for as asset acquisitions which have not reached technological feasibility and which have no alternative future use. Investments The following table reflects the accounting method, carrying value and underlying equity in net assets of our unconsolidated investments as of June 30, 2015 : (in thousands) Investment type Investment Carrying Value Underlying Equity in Net Assets Equity method investments $ 6,746 $ 23,735 Variable interest entity, equity method 903 — Available for sale investments 3,816 Warrants and options 9,969 Total carrying value of investments $ 21,434 Equity Method Investments Our equity method investments consist of investments in Pharmsynthez (ownership 17% ), Cocrystal Pharma, Inc. (“COCP”) ( 8% ), Sevion Therapeutics, Inc. (“Sevion”) ( 4% ), Non-Invasive Monitoring Systems, Inc. ( 1% ) and Neovasc ( 5% ). The total assets, liabilities, and net losses of our equity method investees as of and for the six months ended June 30, 2015 were $403.2 million , $(96.7) million , and $(52.5) million , respectively. We have determined that we and/or our related parties can significantly influence the success of our equity method investments through our board representation and voting power. Accordingly, we account for our investment in these entities under the equity method. For investments classified under the equity method of accounting, we record our proportionate share of their losses in Loss from investments in investees in our Condensed Consolidated Statement of Operations. The aggregate value of our equity method investments based on the quoted market price of their common stock and the number of shares held by us as of June 30, 2015 is $88.1 million . See further discussion of our investment in Pharmsynthez below. Available for Sale Investments Our available for sale investments consist of investments in RXi Pharmaceuticals Corporation (“RXi”) (ownership 10% ), ChromaDex Corporation ( 2% ) and ARNO Therapeutics, Inc. (“ARNO”) ( 4% ). We have determined that our ownership, along with that of our related parties, does not provide us with significant influence over the operations of our available for sale investments. Accordingly, we account for our investment in these entities as available for sale, and we record changes in these investments as an unrealized gain or loss in Other comprehensive income (loss) each reporting period. Sales of Investments Gains (losses) included in earnings from sales of our investments for the six months ended June 30, 2014 were $1.3 million and were recorded in Other income (expense), net in our Condensed Consolidated Statement of Operations. We did not have any such activity in the six months ended June 30, 2015 . The cost of securities sold is based on the specific identification method. Warrants and Options In addition to our equity method investments and available for sale investments, we hold options to purchase 1.0 million additional shares of Neovasc, which are fully vested as of December 31, 2014, and 1.0 million , 0.8 million , 0.1 million and 1.7 million of warrants to purchase additional shares of COCP, ARNO, Sevion and MabVax Therapeutics Holdings, Inc., respectively. We recorded the changes in the fair value of the options and warrants in Fair value changes of derivative instruments, net in our Consolidated Statements of Operations. We record the fair value of the options and warrants in Investments, net in our Consolidated Balance Sheets. See further discussion of the Company’s options and warrants in Note 8 and Note 9. Pharmsynthez transactions In April 2013, we entered into a series of concurrent transactions with Pharmsynthez, a Russian pharmaceutical company traded on the Moscow Stock Exchange. The transactions consisted of: • We delivered approximately $9.6 million in cash to Pharmsynthez. • Pharmsynthez issued to us approximately 13.6 million of its common shares. • Pharmsynthez agreed, at its option, to issue approximately 12.0 million common shares to us or to pay us cash in Russian Rubles (“RUR”) 265.0 million ( $8.1 million at December 31, 2013) on or before December 31, 2013 (the “Pharmsynthez Note Receivable”). In January 2014, Pharmsynthez delivered to us approximately 12.0 million shares of its common stock in satisfaction of the Pharmsynthez Notes Receivable. • We had a right to purchase additional shares in Pharmsynthez at a fixed price if Pharmsynthez paid us in cash rather than delivering to us the 12.0 million Pharmsynthez common shares (the “Purchase Option”), however in connection with the settlement of the Pharmsynthez Note Receivable in January 2014, this right terminated. • We granted rights to certain technologies in the Russian Federation, Ukraine, Belarus, Azerbaijan and Kazakhstan (the “Territories”) to Pharmsynthez. • We will receive from Pharmsynthez royalties on net sales of products incorporating the technologies in the Territories, as well as a percentage of any sublicense income from third parties for the technologies in the Territories. • Pharmsynthez paid us $9.5 million under the various collaboration and funding agreements for the grant of rights and development of the technologies (the “Collaboration Payments”). We recorded the shares received in Pharmsynthez as an equity method investment. We initially recorded the Pharmsynthez Note Receivable, and the Purchase Option, as financial instruments and elected the fair value option for subsequent measurement. Changes in the fair value of the Pharmsynthez Note Receivable and the Purchase Option were recorded in Fair value changes of derivative instruments, net in our Condensed Consolidated Statements of Operations. Upon settlement in January 2014, we recorded the additional shares at fair value as an equity method investment. We have accounted for the license and development activities as a multi-element arrangement, and allocated the total arrangement consideration based on the relative selling prices of the elements. We record the allocated consideration for development activities as an offset to Research and development expenses over the three -year term of the Collaboration Payments. We recorded revenue in connection with the grant of rights to the technologies proportionately as the payments were received. During the six months ended June 30, 2015 and 2014, we recorded $0 million and $0.5 million , respectively, in Revenue from transfer of intellectual property and $0.5 million and $0.8 million , respectively, as an offset to Research and development expenses related to the Collaboration Payments. Investments in variable interest entities We have determined that we hold variable interests in SciVac and Zebra Biologics, Inc. (“Zebra”). We made this determination as a result of our assessment that they do not have sufficient resources to carry out their principal activities without additional financial support. We own 840,000 shares of Zebra Series A-2 Preferred Stock and 900,000 shares of Zebra restricted common stock (ownership 28% at June 30, 2015 ). Zebra is a privately held biotechnology company focused on the discovery and development of biosuperior antibody therapeutics and complex drugs. Dr. Richard Lerner, M.D., a member of our Board of Directors, is a founder of Zebra and, along with Dr. Frost, serves as a member of Zebra’s Board of Directors. In order to determine the primary beneficiary of Zebra, we evaluated our investment and our related parties’ investment, as well as our investment combined with the related party group’s investment to identify if we had the power to direct the activities that most significantly impact the economic performance of Zebra. We determined that we do not have the power to direct the activities that most significantly impact Zebra’s economic performance. Based on the capital structure, governing documents and overall business operations of Zebra, we determined that, while a VIE, we do not have the power to direct the activities that most significantly impact Zebra’s economic performance. We did determine, however, that we can significantly influence the success of Zebra through our board representation and voting power. Therefore, we have the ability to exercise significant influence over Zebra’s operations and account for our investment in Zebra under the equity method. Consolidated variable interest entities In June 2012, we acquired a 50% stock ownership in SciVac ( 45% as of June 30, 2015 ) from FDS Pharma LLP (“FDS”). SciVac is a privately-held Israeli company that produces a third-generation hepatitis B-vaccine. From November 2012 until June 30, 2015 , we loaned to SciVac a combined $7.6 million for working capital purposes. We have determined that we hold variable interests in SciVac based on our assessment that SciVac does not have sufficient resources to carry out its principal activities without financial support. In order to determine the fair market value of our investment in SciVac, we have utilized a business enterprise valuation approach. In order to determine the primary beneficiary of SciVac, we evaluated our investment to identify if we had the power to direct the activities that most significantly impact the economic performance of SciVac. We have determined that the power to direct the activities that most significantly impact the economic performance of SciVac is conveyed through SciVac’s board of directors. SciVac’s board of directors appoint and oversee SciVac’s management team who carry out the activities that most significantly impact the economic performance of SciVac. As part of the share and debt purchase agreement, SciVac’s board of directors is constituted by 5 members, of which 3 members are appointed by us, representing 60% of SciVac’s board. Based on this analysis, we determined that we have the power to direct the activities of SciVac and as such we are the primary beneficiary. As a result of this conclusion, we have consolidated the results of operations and financial position of SciVac and recorded a reduction of equity for the portion of SciVac we do not own. The following table represents the consolidated assets and non-recourse liabilities related to SciVac as of June 30, 2015 and December 31, 2014. These assets are owned by, and these liabilities are obligations of, SciVac, not us. (In thousands) June 30, December 31, 2014 Assets Current assets: Cash and cash equivalents $ 21 $ 393 Accounts receivable, net 304 316 Inventories, net 1,433 1,649 Prepaid expenses and other current assets 774 718 Total current assets 2,532 3,076 Property, plant and equipment, net 1,791 1,725 Intangible assets, net 843 875 Goodwill 1,602 1,553 Other assets 368 384 Total assets $ 7,136 $ 7,613 Liabilities Current liabilities: Accounts payable $ 900 $ 445 Accrued expenses 4,476 4,446 Notes payable 5,409 5,189 Total current liabilities 10,785 10,080 Other long-term liabilities 1,884 2,042 Total liabilities $ 12,669 $ 12,122 In March 2015, SciVac entered into an agreement pursuant to which Levon Resources Ltd. ("Levon") agreed to acquire 100% of the issued and outstanding ordinary shares of SciVac by way of a court-approved plan of arrangement (the "Arrangement"). Upon closing, which occurred in July 2015, Levon changed its name to SciVac Therapeutics Inc. ("New SciVac"), and the officers and directors of SciVac became officers and directors of New SciVac. The former owners of SciVac now hold 68.4% of the outstanding shares of New SciVac, resulting in our ownership interest of approximately 24.5% . |