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Opko Health, Inc. – ‘10-Q’ for 3/31/16 – ‘R21’

On:  Monday, 5/9/16, at 4:27pm ET   ·   For:  3/31/16   ·   Accession #:  944809-16-22   ·   File #:  1-33528

Previous ‘10-Q’:  ‘10-Q’ on 11/9/15 for 9/30/15   ·   Next:  ‘10-Q’ on 8/8/16 for 6/30/16   ·   Latest:  ‘10-Q’ on 5/7/24 for 3/31/24

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  As Of               Filer                 Filing    For·On·As Docs:Size

 5/09/16  Opko Health, Inc.                 10-Q        3/31/16   77:8.6M

Quarterly Report   —   Form 10-Q   —   Sect. 13 / 15(d) – SEA’34
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10-Q        Quarterly Report                                    HTML    593K 
 2: EX-31.1     Certification -- §302 - SOA'02                      HTML     29K 
 3: EX-31.2     Certification -- §302 - SOA'02                      HTML     29K 
 4: EX-32.1     Certification -- §906 - SOA'02                      HTML     23K 
 5: EX-32.2     Certification -- §906 - SOA'02                      HTML     23K 
12: R1          Document and Entity Information                     HTML     41K 
13: R2          Condensed Consolidated Balance Sheets (Unaudited)   HTML    105K 
14: R3          Condensed Consolidated Balance Sheets (Unaudited)   HTML     31K 
                (Parenthetical)                                                  
15: R4          Condensed Consolidated Statements of Operations     HTML     91K 
                (Unaudited)                                                      
16: R5          Condensed Consolidated Statements of Comprehensive  HTML     44K 
                Loss (Unaudited)                                                 
17: R6          Condensed Consolidated Statements of Cash Flows     HTML    134K 
                (Unaudited)                                                      
18: R7          Condensed Consolidated Statements of Cash Flows     HTML     25K 
                (Unaudited) (Parenthetical)                                      
19: R8          Business and Organization                           HTML     33K 
20: R9          Summary of Significant Accounting Policies          HTML     76K 
21: R10         Earnings (Loss) Per Share                           HTML     29K 
22: R11         Composition of Certain Financial Statement          HTML    130K 
                Captions                                                         
23: R12         Acquisitions, Investments and Licenses              HTML    116K 
24: R13         Debt                                                HTML    131K 
25: R14         Accumulated Other Comprehensive Income (Loss)       HTML     38K 
26: R15         Fair Value Measurements                             HTML    145K 
27: R16         Derivative Contracts                                HTML     53K 
28: R17         Related Party Transactions                          HTML     32K 
29: R18         Commitments and Contingencies                       HTML     36K 
30: R19         Strategic Alliances                                 HTML     43K 
31: R20         Segments                                            HTML    104K 
32: R21         Subsequent Events                                   HTML     34K 
33: R22         Summary of Significant Accounting Policies          HTML    132K 
                (Policies)                                                       
34: R23         Composition of Certain Financial Statement          HTML    131K 
                Captions (Tables)                                                
35: R24         Acquisitions, Investments and Licenses (Tables)     HTML     90K 
36: R25         Debt (Tables)                                       HTML    114K 
37: R26         Accumulated Other Comprehensive Income (Loss)       HTML     35K 
                (Tables)                                                         
38: R27         Fair Value Measurements (Tables)                    HTML    143K 
39: R28         Derivative Contracts (Tables)                       HTML     48K 
40: R29         Segments (Tables)                                   HTML     97K 
41: R30         Business and Organization (Details)                 HTML     48K 
42: R31         Summary of Significant Accounting Policies          HTML     97K 
                (Details)                                                        
43: R32         Earnings (Loss) Per Share (Details)                 HTML     34K 
44: R33         Composition of Certain Financial Statement          HTML    143K 
                Captions (Details)                                               
45: R34         Composition of Certain Financial Statement          HTML     61K 
                Captions - Changes in Goodwill (Details)                         
46: R35         Acquisitions, Investments and Licenses -            HTML     78K 
                Acquisition Narrative (Details)                                  
47: R36         Acquisitions, Investments and Licenses -            HTML     84K 
                Bio-Reference Purchase Price Allocation (Details)                
48: R37         Acquisitions, Investments and Licenses - Schedule   HTML     32K 
                of Pro Forma (Details)                                           
49: R38         Acquisitions, Investments and Licenses - EirGen     HTML     63K 
                Purchase Price Allocation (Details)                              
50: R39         Acquisitions, Investments and Licenses - Summary    HTML     36K 
                of Investments (Details)                                         
51: R40         Acquisitions, Investments and Licenses - Equity     HTML     52K 
                Method Investments Narrative (Details)                           
52: R41         Acquisitions, Investments and Licenses - Available  HTML     47K 
                for Sale Investments, Sale of Investments and                    
                Warrants and Options Narrative (Details)                         
53: R42         Acquisitions, Investments and Licenses - Variable   HTML     60K 
                Interest Entities Narrative (Details)                            
54: R43         Acquisitions, Investments and Licenses - Other      HTML     49K 
                Narrative (Details)                                              
55: R44         Debt - Narrative (Details)                          HTML    144K 
56: R45         Debt - Notes (Details)                              HTML     58K 
57: R46         Debt - Inputs Used In Lattice Model (Details)       HTML     41K 
58: R47         Debt - Fair Value Of Embedded Derivatives           HTML     29K 
                (Details)                                                        
59: R48         Debt - Lines Of Credit (Details)                    HTML     60K 
60: R49         Debt - Mortgage Notes And Other Debt (Details)      HTML     32K 
61: R50         Accumulated Other Comprehensive Income (Loss)       HTML     37K 
                (Details)                                                        
62: R51         Fair Value Measurements - Summary Of Investments    HTML     36K 
                (Details)                                                        
63: R52         Fair Value Measurements - Assets And Liabilities    HTML     60K 
                Measured At Fair Value (Details)                                 
64: R53         Fair Value Measurements - Notes (Details)           HTML     29K 
65: R54         Fair Value Measurements - Level 3 Reconciliation    HTML     38K 
                (Details)                                                        
66: R55         Fair Value Measurements - Narrative (Details)       HTML     34K 
67: R56         Derivative Contracts - Balance Sheet Component      HTML     40K 
                (Details)                                                        
68: R57         Derivative Contracts - Derivative Gains (Losses)    HTML     32K 
                (Details)                                                        
69: R58         Related Party Transactions (Details)                HTML    111K 
70: R59         Commitments and Contingencies (Details)             HTML     37K 
71: R60         Strategic Alliances (Details)                       HTML     96K 
72: R61         Segments - Narrative (Details)                      HTML     42K 
73: R62         Segments - Operations and Assets Information        HTML     74K 
                (Details)                                                        
74: R63         Subsequent Events (Details)                         HTML     63K 
76: XML         IDEA XML File -- Filing Summary                      XML    136K 
75: EXCEL       IDEA Workbook of Financial Reports                  XLSX    108K 
 6: EX-101.INS  XBRL Instance -- opk-20160331                        XML   2.50M 
 8: EX-101.CAL  XBRL Calculations -- opk-20160331_cal                XML    234K 
 9: EX-101.DEF  XBRL Definitions -- opk-20160331_def                 XML   1.06M 
10: EX-101.LAB  XBRL Labels -- opk-20160331_lab                      XML   2.02M 
11: EX-101.PRE  XBRL Presentations -- opk-20160331_pre               XML   1.28M 
 7: EX-101.SCH  XBRL Schema -- opk-20160331                          XSD    190K 
77: ZIP         XBRL Zipped Folder -- 0000944809-16-000022-xbrl      Zip    296K 


‘R21’   —   Subsequent Events


This is an IDEA Financial Report.  [ Alternative Formats ]



 
v3.4.0.3
Subsequent Events
3 Months Ended
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS
On April 6, 2016, we announced that our 2033 Senior Notes continue to be convertible by holders of such notes. We have elected to satisfy our conversion obligation under the 2033 Senior Notes in shares of our Common Stock. This conversion right has been triggered because the closing price per share of our Common Stock has exceeded $9.19, or 130% of the initial conversion price of $7.07, for at least 20 of 30 consecutive trading days during the period ending on March 31, 2016. The conversion right was previously triggered during the quarters ended March 31, 2015, June 30, 2015, September 30, 2015 and December 31, 2015. The 2033 Senior Notes will continue to be convertible until June 30, 2016, and may be convertible thereafter, if one or more of the conversion conditions specified in the Indenture is satisfied during future measurement periods. Pursuant to the Indenture, a holder who elects to convert the 2033 Senior Notes will receive 141.4827 shares of our Common Stock plus such number of additional shares as is applicable on the conversion date per $1,000 principal amount of 2033 Senior Notes based on the early conversion provisions in the Indenture.
In May 2016, EirGen, our wholly-owned subsidiary, and Vifor Fresenius Medical Care Pharma Ltd (“VFMCRP”), entered into a Development and License Agreement (the “Agreement”) for the development and marketing of Rayaldee (the “Product”) worldwide, except for (i) the United States, (ii) any country in Central America or South America (excluding Mexico), (iii) Russia, (iv) China, (v) Japan, (vi) Ukraine, (vii) Belorussia, (viii) Azerbaijan, (ix) Kazakhstan, and (x) Taiwan (the “Territory”). The license to VFMCRP potentially covers all therapeutic and prophylactic uses of the Product in humans (the “Field”), provided that initially the license is for the use of the Product for the treatment or prevention of secondary hyperparathyroidism related to patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency/deficiency (the “Initial Indication”).
Under the terms of the Agreement, EirGen granted to VFMCRP an exclusive license in the Territory in the Field to use certain EirGen patents and technology to make, have made, use, sell, offer for sale, and import Products and to develop, commercialize, have commercialized, and otherwise exploit the Product. EirGen will receive an initial payment of $50 million within ten (10) business days after the effective date of the Agreement. EirGen is also eligible to receive up to an additional aggregate amount of $232 million upon the achievement of certain regulatory and sales-based milestones and will receive tiered, double digit royalty payments upon the commencement of sales of the Product within the Territory and in the Field.
As part of the arrangement, the companies will share responsibility for the conduct of trials specified within an agreed-upon development plan, with each company leading certain activities within the plan. EirGen will lead the manufacturing activities within and outside the Territory and the commercialization activities outside the Territory and outside the Field in the Territory and VFMCRP will lead the commercialization activities in the Territory and the Field. For the initial development plan agreed to by the companies, the companies have agreed to certain cost sharing arrangements. VFMCRP will be responsible for all other development costs that VFMCRP considers necessary to develop the Product for the use of the Product for the Initial Indication in the Territory in the Field except as otherwise provided in the Agreement.
The Agreement will remain in effect with respect to the Product in each country of the Territory, on a country by country basis, until the date on which VFMCRP shall have no further payment obligations to EirGen under the terms of the Agreement, unless earlier terminated pursuant to the Agreement. VFMCRP’s royalty obligations expire on a country-by-country and product-by-product basis on the later of (i) expiration of the last to expire valid claim covering the Product sold in such country, (ii) expiration of all regulatory and data exclusivity applicable to the Product in the country of sale, and (c) ten (10) years after the Product first commercial sale in such country. In addition to termination rights for material breach and bankruptcy, VFMCRP is permitted to terminate the Agreement in its entirety, or with respect to one or more countries in the Territory, after a specified notice period provided that VFMCRP shall not have the right to terminate the Agreement with respect to certain major countries without terminating the entire Agreement. If the Agreement is terminated by EirGen or VFMCRP, provision has been made for transition of product and product responsibilities to EirGen.
In connection with the Agreement, the parties entered into a letter agreement (the “Letter Agreement”) pursuant to which EirGen granted to VFMCRP an exclusive option (the “Option”) to acquire an exclusive license under certain EirGen patents and technology to use, import, offer for sale, sell, distribute and commercialize Product in the United States solely for treatment of secondary hyperparathyroidism in dialysis patients with chronic kidney disease patients and vitamin D insufficiency (the “Dialysis Indication”). Upon exercise of the Option, VFMCRP will reimburse EirGen for all of the development costs incurred by EirGen with respect to the Product for the Dialysis Indication in the United States. VFMCRP would also pay EirGen up to an additional aggregate amount of $555 million upon the achievement of certain milestones and would be obligated to pay certain double digit royalties on VFMCRP's sales in the United States for the Dialysis Indication.
The Option is exercisable until the earlier of (i) the date that EirGen submits a new drug application or supplemental new drug application or their then equivalents to the U.S. Food and Drug Administration for the Product for the Dialysis Indication in the United States, (ii) the parties mutually agree to discontinue development of Product for the Dialysis Indication, or (iii) VFMCRP provides notice to OPKO that it has elected not to exercise the Option.
OPKO has guaranteed the performance of certain of EirGen’s obligations under the Agreement and the Letter Agreement.
We have reviewed all subsequent events and transactions that occurred after the date of our March 31, 2016 Condensed Consolidated Balance Sheet date, through the time of filing this Quarterly Report on Form 10-Q.

Dates Referenced Herein   and   Documents Incorporated by Reference

This ‘10-Q’ Filing    Date    Other Filings
6/30/1610-Q,  4,  8-K
Filed on:5/9/168-K
4/6/164,  8-K
For Period end:3/31/164
12/31/1510-K,  10-K/A,  4
9/30/1510-Q,  4
6/30/1510-Q,  4
3/31/1510-Q,  4
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Filing Submission 0000944809-16-000022   –   Alternative Formats (Word / Rich Text, HTML, Plain Text, et al.)

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