|
|
☒
|
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)
|
||
|
|
|
Title of each class
|
Trading Symbol
|
Name of each exchange on which registered
|
Common Stock, par value $0.01 per share
|
OPK
|
NASDAQ Global Select Market
|
|
Large accelerated filer
|
x
|
Accelerated filer
|
☐
|
Non-accelerated filer
|
¨
|
Smaller reporting company
|
☐
|
|
|
Emerging growth company
|
☐
|
|
Page
|
|||
|
|||
|
|||
•
|
we have a history of losses and may not generate sustained positive cash flow sufficient to fund our operations and research and development programs;
|
•
|
our need for, and ability to obtain, additional financing when needed on favorable terms, or at all;
|
•
|
adverse results in material litigation matters or governmental investigations, including, without limitation, recent lawsuits against the Company and its Chairman and Chief Executive Officer by the SEC, as well as related class action and derivative lawsuits;
|
•
|
the risks inherent in developing, obtaining regulatory approvals for and commercializing new, commercially viable and competitive products and treatments;
|
•
|
our research and development activities may not result in commercially viable products;
|
•
|
that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results;
|
•
|
the success of our relationship with Pfizer;
|
•
|
that we may fail to obtain regulatory approval for hGH-CTP or successfully commercialize Rayaldee and hGH-CTP;
|
•
|
that we may not generate profits or cash flow from our laboratory operations or substantial revenue from Rayaldee and our pharmaceutical and diagnostic products;
|
•
|
availability of insurance coverage with respect to material litigation matters;
|
•
|
that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied;
|
•
|
our ability to build a successful pharmaceutical sales and marketing infrastructure;
|
•
|
our ability and our distribution and marketing partners’ ability to comply with regulatory requirements regarding the sales, marketing and manufacturing of our products and product candidates and the operation of our laboratories;
|
•
|
the performance of our third-party distribution partners, licensees and manufacturers over which we have limited control;
|
•
|
our success is dependent on the involvement and continued efforts of our Chairman and Chief Executive Officer;
|
•
|
integration challenges for acquired businesses;
|
•
|
changes in regulation and policies in the United States (“U.S.”) and other countries, including increasing downward pressure on healthcare reimbursement;
|
•
|
our ability to manage our growth and our expanded operations;
|
•
|
increased competition, including price competition;
|
•
|
changing relationships with payors, including the various state and multi-state Blues programs, suppliers and strategic partners;
|
•
|
efforts by third-party payors to reduce utilization and reimbursement for clinical testing services;
|
•
|
our ability to maintain reimbursement coverage for our products and services, including the 4Kscore test;
|
•
|
failure to timely or accurately bill and collect for our services;
|
•
|
failure in our information technology systems or those of our third party vendors, including cybersecurity attacks or other data security or privacy incidents;
|
•
|
failure to obtain and retain new clients and business partners, or a reduction in tests ordered or specimens submitted by existing clients;
|
•
|
failure to establish, and perform to, appropriate quality standards to assure that the highest level of quality is observed in the performance of our testing services;
|
•
|
failure to maintain the security of patient-related information;
|
•
|
our ability to obtain and maintain intellectual property protection for our products;
|
•
|
our ability to defend our intellectual property rights with respect to our products;
|
•
|
our ability to operate our business without infringing the intellectual property rights of others;
|
•
|
our ability to attract and retain key scientific and management personnel;
|
•
|
the risk that the carrying value of certain assets may exceed the fair value of the assets causing us to impair goodwill or other intangible assets;
|
•
|
failure to obtain and maintain regulatory approval outside the U.S.; and
|
•
|
legal, economic, political, regulatory, currency exchange, and other risks associated with international operations.
|
|
September 30, 2019
|
|
December 31, 2018
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
64,667
|
|
|
$
|
96,473
|
|
Accounts receivable, net
|
140,765
|
|
|
143,907
|
|
||
Inventory, net
|
50,109
|
|
|
42,299
|
|
||
Other current assets and prepaid expenses
|
37,301
|
|
|
35,052
|
|
||
Total current assets
|
292,842
|
|
|
317,731
|
|
||
Property, plant and equipment, net
|
128,519
|
|
|
144,674
|
|
||
Intangible assets, net
|
564,310
|
|
|
614,452
|
|
||
In-process research and development
|
635,000
|
|
|
635,572
|
|
||
Goodwill
|
695,798
|
|
|
700,193
|
|
||
Investments
|
11,695
|
|
|
31,228
|
|
||
Operating lease right-of-use assets
|
35,826
|
|
|
—
|
|
||
Other assets
|
5,528
|
|
|
7,222
|
|
||
Total assets
|
$
|
2,369,518
|
|
|
$
|
2,451,072
|
|
LIABILITIES AND EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
77,296
|
|
|
$
|
47,395
|
|
Accrued expenses
|
172,734
|
|
|
203,513
|
|
||
Current maturities of operating leases
|
12,921
|
|
|
—
|
|
||
Current portion of convertible notes
|
—
|
|
|
31,562
|
|
||
Current portion of lines of credit and notes payable
|
7,187
|
|
|
5,851
|
|
||
Total current liabilities
|
270,138
|
|
|
288,321
|
|
||
Operating lease liabilities
|
23,318
|
|
|
—
|
|
||
Convertible notes
|
208,695
|
|
|
57,299
|
|
||
Deferred tax liabilities, net
|
113,479
|
|
|
115,193
|
|
||
Other long-term liabilities, principally contract liabilities, contingent consideration and line of credit
|
111,959
|
|
|
198,968
|
|
||
Total long-term liabilities
|
457,451
|
|
|
371,460
|
|
||
Total liabilities
|
727,589
|
|
|
659,781
|
|
||
Equity:
|
|
|
|
||||
Common Stock - $0.01 par value, 1,000,000,000 and 750,000,000 shares authorized at September 30, 2019 and December 31, 2018, respectively; 616,150,952 and 586,881,720 shares issued at September 30, 2019 and December 31, 2018, respectively
|
6,162
|
|
|
5,869
|
|
||
Treasury Stock - 549,907 and 549,907 shares at September 30, 2019 and December 31, 2018, respectively
|
(1,791
|
)
|
|
(1,791
|
)
|
||
Additional paid-in capital
|
3,065,059
|
|
|
3,004,422
|
|
||
Accumulated other comprehensive loss
|
(28,774
|
)
|
|
(20,131
|
)
|
||
Accumulated deficit
|
(1,398,727
|
)
|
|
(1,197,078
|
)
|
||
Total shareholders’ equity
|
1,641,929
|
|
|
1,791,291
|
|
||
Total liabilities and equity
|
$
|
2,369,518
|
|
|
$
|
2,451,072
|
|
|
For the three months ended September 30,
|
|
For the nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Revenue from services
|
$
|
181,139
|
|
|
$
|
202,811
|
|
|
$
|
538,488
|
|
|
$
|
630,180
|
|
Revenue from products
|
26,161
|
|
|
25,395
|
|
|
80,143
|
|
|
81,769
|
|
||||
Revenue from transfer of intellectual property and other
|
21,472
|
|
|
21,609
|
|
|
58,961
|
|
|
56,463
|
|
||||
Total revenues
|
228,772
|
|
|
249,815
|
|
|
677,592
|
|
|
768,412
|
|
||||
Costs and expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of service revenue
|
126,348
|
|
|
137,347
|
|
|
386,329
|
|
|
411,196
|
|
||||
Cost of product revenue
|
15,573
|
|
|
13,609
|
|
|
43,874
|
|
|
43,909
|
|
||||
Selling, general and administrative
|
80,542
|
|
|
84,071
|
|
|
264,175
|
|
|
263,242
|
|
||||
Research and development
|
30,017
|
|
|
30,160
|
|
|
94,832
|
|
|
92,258
|
|
||||
Contingent consideration
|
(1,109
|
)
|
|
1,193
|
|
|
(78
|
)
|
|
(12,406
|
)
|
||||
Amortization of intangible assets
|
16,412
|
|
|
16,899
|
|
|
49,393
|
|
|
51,397
|
|
||||
Asset impairment charges
|
—
|
|
|
—
|
|
|
655
|
|
|
—
|
|
||||
Total costs and expenses
|
267,783
|
|
|
283,279
|
|
|
839,180
|
|
|
849,596
|
|
||||
Operating loss
|
(39,011
|
)
|
|
(33,464
|
)
|
|
(161,588
|
)
|
|
(81,184
|
)
|
||||
Other income and (expense), net:
|
|
|
|
|
|
|
|
||||||||
Interest income
|
350
|
|
|
43
|
|
|
1,477
|
|
|
111
|
|
||||
Interest expense
|
(5,792
|
)
|
|
(2,944
|
)
|
|
(16,048
|
)
|
|
(7,933
|
)
|
||||
Fair value changes of derivative instruments, net
|
(21
|
)
|
|
(155
|
)
|
|
6
|
|
|
3,489
|
|
||||
Other income (expense), net
|
(15,470
|
)
|
|
(824
|
)
|
|
(20,367
|
)
|
|
9,653
|
|
||||
Other income and (expense), net
|
(20,933
|
)
|
|
(3,880
|
)
|
|
(34,932
|
)
|
|
5,320
|
|
||||
Loss before income taxes and investment losses
|
(59,944
|
)
|
|
(37,344
|
)
|
|
(196,520
|
)
|
|
(75,864
|
)
|
||||
Income tax benefit (provision)
|
(1,769
|
)
|
|
11,563
|
|
|
(3,636
|
)
|
|
10,437
|
|
||||
Net loss before investment losses
|
(61,713
|
)
|
|
(25,781
|
)
|
|
(200,156
|
)
|
|
(65,427
|
)
|
||||
Loss from investments in investees
|
(294
|
)
|
|
(1,874
|
)
|
|
(2,419
|
)
|
|
(11,542
|
)
|
||||
Net loss
|
$
|
(62,007
|
)
|
|
$
|
(27,655
|
)
|
|
$
|
(202,575
|
)
|
|
$
|
(76,969
|
)
|
Loss per share, basic and diluted:
|
|
|
|
|
|
|
|
||||||||
Loss per share
|
$
|
(0.11
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.35
|
)
|
|
$
|
(0.14
|
)
|
Weighted average common shares outstanding, basic and diluted
|
586,351,045
|
|
|
559,786,382
|
|
|
586,348,791
|
|
|
559,601,097
|
|
|
For the three months ended September 30,
|
|
For the nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net loss
|
$
|
(62,007
|
)
|
|
$
|
(27,655
|
)
|
|
$
|
(202,575
|
)
|
|
$
|
(76,969
|
)
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
|
||||||||
Change in foreign currency translation and other comprehensive income (loss)
|
(8,423
|
)
|
|
(134
|
)
|
|
(8,643
|
)
|
|
(7,734
|
)
|
||||
Investments:
|
|
|
|
|
|
|
|
||||||||
Reclassification adjustment due to adoption of ASU 2016-01
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,876
|
)
|
||||
Comprehensive loss
|
$
|
(70,430
|
)
|
|
$
|
(27,789
|
)
|
|
$
|
(211,218
|
)
|
|
$
|
(89,579
|
)
|
|
Common Stock
|
|
Treasury
|
|
Additional
Paid-In Capital |
|
Accumulated Other
Comprehensive Loss |
|
Accumulated
Deficit |
|
Total
|
||||||||||||||||||
|
Shares
|
|
Dollars
|
|
Shares
|
|
Dollars
|
|
|
||||||||||||||||||||
Balance at June 30, 2019
|
616,150,952
|
|
|
$
|
6,162
|
|
|
(549,907
|
)
|
|
$
|
(1,791
|
)
|
|
$
|
3,061,631
|
|
|
$
|
(20,351
|
)
|
|
$
|
(1,336,720
|
)
|
|
$
|
1,708,931
|
|
Equity-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,428
|
|
|
—
|
|
|
—
|
|
|
3,428
|
|
||||||
Exercise of Common Stock options and warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Adoption of ASU 2018-07
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
2025 convertible notes including share lending arrangement
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(62,007
|
)
|
|
(62,007
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,423
|
)
|
|
—
|
|
|
(8,423
|
)
|
||||||
Balance at September 30, 2019
|
616,150,952
|
|
|
$
|
6,162
|
|
|
(549,907
|
)
|
|
$
|
(1,791
|
)
|
|
$
|
3,065,059
|
|
|
$
|
(28,774
|
)
|
|
$
|
(1,398,727
|
)
|
|
$
|
1,641,929
|
|
|
Common Stock
|
|
Treasury
|
|
Additional
Paid-In Capital |
|
Accumulated Other
Comprehensive Loss |
|
Accumulated
Deficit |
|
Total
|
||||||||||||||||||
|
Shares
|
|
Dollars
|
|
Shares
|
|
Dollars
|
|
|
||||||||||||||||||||
Balance at December 31, 2018
|
586,881,720
|
|
|
$
|
5,869
|
|
|
(549,907
|
)
|
|
$
|
(1,791
|
)
|
|
$
|
3,004,422
|
|
|
$
|
(20,131
|
)
|
|
$
|
(1,197,078
|
)
|
|
$
|
1,791,291
|
|
Equity-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11,007
|
|
|
—
|
|
|
—
|
|
|
11,007
|
|
||||||
Exercise of Common Stock options and warrants
|
19,232
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3
|
)
|
|
—
|
|
|
—
|
|
|
(3
|
)
|
||||||
Adoption of ASU 2018-07
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(926
|
)
|
|
—
|
|
|
926
|
|
|
—
|
|
||||||
2025 convertible notes including share lending arrangement
|
29,250,000
|
|
|
293
|
|
|
—
|
|
|
—
|
|
|
50,559
|
|
|
—
|
|
|
—
|
|
|
50,852
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(202,575
|
)
|
|
(202,575
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,643
|
)
|
|
—
|
|
|
(8,643
|
)
|
||||||
Balance at September 30, 2019
|
616,150,952
|
|
|
$
|
6,162
|
|
|
(549,907
|
)
|
|
$
|
(1,791
|
)
|
|
$
|
3,065,059
|
|
|
$
|
(28,774
|
)
|
|
$
|
(1,398,727
|
)
|
|
$
|
1,641,929
|
|
|
Common Stock
|
|
Treasury
|
|
Additional
Paid-In Capital |
|
Accumulated Other
Comprehensive Loss |
|
Accumulated
Deficit |
|
Total
|
||||||||||||||||||
|
Shares
|
|
Dollars
|
|
Shares
|
|
Dollars
|
|
|
||||||||||||||||||||
Balance at June 30, 2018
|
560,169,422
|
|
|
$
|
5,602
|
|
|
(549,907
|
)
|
|
$
|
(1,791
|
)
|
|
$
|
2,901,086
|
|
|
$
|
(13,004
|
)
|
|
$
|
(1,093,353
|
)
|
|
$
|
1,798,540
|
|
Equity-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,077
|
|
|
—
|
|
|
—
|
|
|
5,077
|
|
||||||
Exercise of Common Stock options and warrants
|
208,000
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
854
|
|
|
—
|
|
|
—
|
|
|
856
|
|
||||||
Adoption of ASU 2016-01
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(27,655
|
)
|
|
(27,655
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(134
|
)
|
|
—
|
|
|
(134
|
)
|
||||||
Balance at September 30, 2018
|
560,377,422
|
|
|
$
|
5,604
|
|
|
(549,907
|
)
|
|
$
|
(1,791
|
)
|
|
$
|
2,907,017
|
|
|
$
|
(13,138
|
)
|
|
$
|
(1,121,008
|
)
|
|
$
|
1,776,684
|
|
|
Common Stock
|
|
Treasury
|
|
Additional
Paid-In Capital |
|
Accumulated Other
Comprehensive Loss |
|
Accumulated
Deficit |
|
Total
|
||||||||||||||||||
|
Shares
|
|
Dollars
|
|
Shares
|
|
Dollars
|
|
|
||||||||||||||||||||
Balance at December 31, 2017
|
560,023,745
|
|
|
$
|
5,600
|
|
|
(549,907
|
)
|
|
$
|
(1,791
|
)
|
|
$
|
2,889,256
|
|
|
$
|
(528
|
)
|
|
$
|
(1,048,914
|
)
|
|
$
|
1,843,623
|
|
Equity-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
16,591
|
|
|
—
|
|
|
—
|
|
|
16,591
|
|
||||||
Exercise of Common Stock options and warrants
|
353,677
|
|
|
4
|
|
|
—
|
|
|
—
|
|
|
1,170
|
|
|
—
|
|
|
—
|
|
|
1,174
|
|
||||||
Adoption of ASU 2016-01
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,876
|
)
|
|
4,876
|
|
|
—
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(76,969
|
)
|
|
(76,969
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,734
|
)
|
|
—
|
|
|
(7,734
|
)
|
||||||
Balance at September 30, 2018
|
560,377,422
|
|
|
$
|
5,604
|
|
|
(549,907
|
)
|
|
$
|
(1,791
|
)
|
|
$
|
2,907,017
|
|
|
$
|
(13,138
|
)
|
|
$
|
(1,121,007
|
)
|
|
$
|
1,776,685
|
|
|
For the nine months ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(202,575
|
)
|
|
$
|
(76,969
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
||||
Depreciation and amortization
|
71,281
|
|
|
73,440
|
|
||
Non-cash interest
|
4,558
|
|
|
3,559
|
|
||
Amortization of deferred financing costs
|
506
|
|
|
155
|
|
||
Losses from investments in investees
|
2,419
|
|
|
11,542
|
|
||
Equity-based compensation – employees and non-employees
|
11,007
|
|
|
16,591
|
|
||
Realized loss (gain) on disposal of fixed assets and sales of equity securities
|
1,455
|
|
|
34
|
|
||
Change in fair value of equity securities and derivative instruments
|
17,178
|
|
|
(14,346
|
)
|
||
Change in fair value of contingent consideration
|
(78
|
)
|
|
(12,406
|
)
|
||
Impairment of assets
|
655
|
|
|
—
|
|
||
Deferred income tax (benefit) provision
|
2,065
|
|
|
(14,541
|
)
|
||
Changes in assets and liabilities, net of the effects of acquisitions:
|
|
|
|
||||
Accounts receivable, net
|
3,257
|
|
|
7,701
|
|
||
Inventory, net
|
(9,543
|
)
|
|
4,057
|
|
||
Other current assets and prepaid expenses
|
(2,556
|
)
|
|
(4,304
|
)
|
||
Other assets
|
240
|
|
|
(4,633
|
)
|
||
Accounts payable
|
30,597
|
|
|
(9,329
|
)
|
||
Foreign currency measurement
|
147
|
|
|
57
|
|
||
Contract liabilities
|
(56,860
|
)
|
|
(50,531
|
)
|
||
Accrued expenses and other liabilities
|
(238
|
)
|
|
(4,559
|
)
|
||
Net cash used in operating activities
|
(126,485
|
)
|
|
(74,482
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Investments in investees
|
(1,200
|
)
|
|
(1,000
|
)
|
||
Proceeds from sale of equity securities
|
—
|
|
|
1,516
|
|
||
Proceeds from the sale of property, plant and equipment
|
552
|
|
|
1,070
|
|
||
Capital expenditures
|
(8,866
|
)
|
|
(24,823
|
)
|
||
Net cash used in investing activities
|
(9,514
|
)
|
|
(23,237
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Issuance of convertible notes, including to related parties
|
200,293
|
|
|
55,000
|
|
||
Debt issuance costs
|
(7,762
|
)
|
|
—
|
|
||
Proceeds from the exercise of Common Stock options and warrants
|
(3
|
)
|
|
1,173
|
|
||
Borrowings on lines of credit
|
99,353
|
|
|
22,468
|
|
||
Repayments of lines of credit
|
(158,477
|
)
|
|
(28,435
|
)
|
||
Redemption of 2033 Senior Notes
|
(28,800
|
)
|
|
—
|
|
||
Net cash provided by financing activities
|
104,604
|
|
|
50,206
|
|
||
Effect of exchange rate changes on cash and cash equivalents
|
(411
|
)
|
|
(268
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
(31,806
|
)
|
|
(47,781
|
)
|
||
Cash and cash equivalents at beginning of period
|
96,473
|
|
|
91,499
|
|
||
Cash and cash equivalents at end of period
|
$
|
64,667
|
|
|
$
|
43,718
|
|
SUPPLEMENTAL INFORMATION:
|
|
|
|
||||
Interest paid
|
$
|
11,084
|
|
|
$
|
1,631
|
|
Income taxes paid, net of refunds
|
$
|
3,103
|
|
|
$
|
3,883
|
|
Operating lease right-of-use assets due to adoption of ASU No. 2016-02
|
$
|
35,826
|
|
|
$
|
—
|
|
Operating lease liabilities due to adoption of ASU No. 2016-02
|
$
|
36,239
|
|
|
$
|
—
|
|
Non-cash financing:
|
|
|
|
||||
Shares issued upon the conversion of:
|
|
|
|
||||
Common Stock options and warrants, surrendered in net exercise
|
$
|
20
|
|
|
$
|
806
|
|
(In thousands)
|
September 30,
2019 |
|
December 31,
2018 |
||||
Accounts receivable, net:
|
|
|
|
||||
Accounts receivable
|
$
|
142,605
|
|
|
$
|
145,665
|
|
Less: allowance for doubtful accounts
|
(1,840
|
)
|
|
(1,758
|
)
|
||
|
$
|
140,765
|
|
|
$
|
143,907
|
|
Inventories, net:
|
|
|
|
||||
Consumable supplies
|
$
|
23,022
|
|
|
$
|
23,264
|
|
Finished products
|
22,137
|
|
|
15,259
|
|
||
Work in-process
|
3,239
|
|
|
2,473
|
|
||
Raw materials
|
4,264
|
|
|
4,259
|
|
||
Less: inventory reserve
|
(2,553
|
)
|
|
(2,956
|
)
|
||
|
$
|
50,109
|
|
|
$
|
42,299
|
|
Other current assets and prepaid expenses:
|
|
|
|
||||
Taxes recoverable
|
19,705
|
|
|
15,708
|
|
||
Other receivables
|
194
|
|
|
2,368
|
|
||
Prepaid supplies
|
8,915
|
|
|
9,693
|
|
||
Prepaid insurance
|
5,160
|
|
|
3,436
|
|
||
Other
|
3,327
|
|
|
3,847
|
|
||
|
$
|
37,301
|
|
|
$
|
35,052
|
|
Intangible assets, net:
|
|
|
|
||||
Customer relationships
|
$
|
444,524
|
|
|
$
|
446,296
|
|
Technologies
|
340,539
|
|
|
340,729
|
|
||
Trade names
|
49,779
|
|
|
50,404
|
|
||
Licenses
|
5,766
|
|
|
5,766
|
|
||
Covenants not to compete
|
16,314
|
|
|
16,322
|
|
||
Product registrations
|
7,554
|
|
|
7,861
|
|
||
Other
|
5,974
|
|
|
5,613
|
|
||
Less: accumulated amortization
|
(306,140
|
)
|
|
(258,539
|
)
|
||
|
$
|
564,310
|
|
|
$
|
614,452
|
|
Accrued expenses:
|
|
|
|
||||
Contract liabilities
|
$
|
30,951
|
|
|
$
|
63,503
|
|
Employee benefits
|
34,138
|
|
|
45,621
|
|
||
Clinical trials
|
9,975
|
|
|
10,401
|
|
||
Contingent consideration
|
2,375
|
|
|
2,375
|
|
||
Finance leases short-term
|
2,983
|
|
|
3,280
|
|
||
Milestone payment
|
5,000
|
|
|
4,871
|
|
||
Professional fees
|
2,877
|
|
|
7,935
|
|
||
Other
|
84,435
|
|
|
65,527
|
|
||
|
$
|
172,734
|
|
|
$
|
203,513
|
|
|
|
|
|
(In thousands)
|
September 30,
2019 |
|
December 31,
2018 |
||||
Other long-term liabilities:
|
|
|
|
||||
Contract liabilities
|
$
|
3,257
|
|
|
$
|
27,566
|
|
Line of credit
|
50,644
|
|
|
105,198
|
|
||
Contingent consideration
|
22,084
|
|
|
22,162
|
|
||
Mortgages and other debts payable
|
4,091
|
|
|
4,654
|
|
||
Finance leases long-term
|
4,325
|
|
|
5,620
|
|
||
Other
|
27,558
|
|
|
33,768
|
|
||
|
$
|
111,959
|
|
|
$
|
198,968
|
|
|
2019
|
||||||||||
(In thousands)
|
Balance at January 1
|
|
Foreign exchange and other
|
|
Balance at September 30th
|
||||||
Pharmaceuticals
|
|
|
|
|
|
||||||
CURNA
|
$
|
4,827
|
|
|
$
|
—
|
|
|
$
|
4,827
|
|
EirGen
|
85,245
|
|
|
(3,933
|
)
|
|
81,312
|
|
|||
FineTech
|
—
|
|
|
—
|
|
|
—
|
|
|||
OPKO Chile
|
4,614
|
|
|
(212
|
)
|
|
4,402
|
|
|||
OPKO Biologics
|
139,784
|
|
|
—
|
|
|
139,784
|
|
|||
OPKO Health Europe
|
7,546
|
|
|
(348
|
)
|
|
7,198
|
|
|||
OPKO Renal
|
2,069
|
|
|
—
|
|
|
2,069
|
|
|||
Transition Therapeutics
|
3,322
|
|
|
98
|
|
|
3,420
|
|
|||
|
|
|
|
|
|
||||||
Diagnostics
|
|
|
|
|
|
||||||
BioReference
|
401,821
|
|
|
—
|
|
|
401,821
|
|
|||
OPKO Diagnostics
|
17,977
|
|
|
—
|
|
|
17,977
|
|
|||
OPKO Lab
|
32,988
|
|
|
—
|
|
|
32,988
|
|
|||
|
$
|
700,193
|
|
|
$
|
(4,395
|
)
|
|
$
|
695,798
|
|
(in thousands)
|
|
|
|
|
||||
Investment type
|
|
Investment Carrying Value
|
|
Underlying Equity in Net Assets
|
||||
Equity method investments
|
|
$
|
1,448
|
|
|
$
|
10,268
|
|
Variable interest entity, equity method
|
|
963
|
|
|
—
|
|
||
Equity securities
|
|
9,129
|
|
|
|
|||
Equity securities with no readily determinable fair value
|
|
35
|
|
|
|
|||
Warrants and options
|
|
120
|
|
|
|
|||
Total carrying value of investments
|
|
$
|
11,695
|
|
|
|
(In thousands)
|
2025 Senior Notes
|
|
Discount
|
|
Debt Issuance Cost
|
|
Total
|
||||||||
Balance at December 31, 2018
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Issuance of 4.50% convertible notes
|
200,000
|
|
|
(52,600
|
)
|
|
(5,720
|
)
|
|
141,680
|
|
||||
Amortization of debt discount and debt issuance costs
|
—
|
|
|
4,131
|
|
|
449
|
|
|
4,580
|
|
||||
Balance at September 30, 2019
|
$
|
200,000
|
|
|
$
|
(48,469
|
)
|
|
$
|
(5,271
|
)
|
|
$
|
146,260
|
|
(Dollars in thousands)
|
|
|
|
|
|
Balance Outstanding
|
||||||||
Lender
|
|
Interest rate on
borrowings at September 30, 2019
|
|
Credit line
capacity
|
|
September 30,
2019 |
|
December 31,
2018
|
||||||
JPMorgan Chase
|
|
4.20%
|
|
$
|
100,000
|
|
|
$
|
50,644
|
|
|
$
|
105,198
|
|
Itau Bank
|
|
5.50%
|
|
1,810
|
|
|
1,027
|
|
|
232
|
|
|||
Bank of Chile
|
|
6.60%
|
|
3,800
|
|
|
1,059
|
|
|
432
|
|
|||
BICE Bank
|
|
5.50%
|
|
2,500
|
|
|
854
|
|
|
818
|
|
|||
BBVA Bank
|
|
5.50%
|
|
3,250
|
|
|
11
|
|
|
858
|
|
|||
Security Bank
|
|
5.50%
|
|
294
|
|
|
294
|
|
|
—
|
|
|||
Estado Bank
|
|
5.50%
|
|
3,500
|
|
|
888
|
|
|
308
|
|
|||
Santander Bank
|
|
5.50%
|
|
4,500
|
|
|
1,044
|
|
|
852
|
|
|||
Scotiabank
|
|
5.00%
|
|
1,800
|
|
|
307
|
|
|
2
|
|
|||
Banco De Sabadell
|
|
1.45%
|
|
327
|
|
|
—
|
|
|
—
|
|
|||
Banco Bilbao Vizcaya
|
|
2.75%
|
|
327
|
|
|
—
|
|
|
—
|
|
|||
Banco Santander
|
|
1.40%
|
|
327
|
|
|
—
|
|
|
10
|
|
|||
Total
|
|
|
|
$
|
122,435
|
|
|
$
|
56,128
|
|
|
$
|
108,710
|
|
(In thousands)
|
September 30,
2019 |
|
December 31,
2018
|
||||
Current portion of notes payable
|
$
|
1,903
|
|
|
$
|
2,560
|
|
Other long-term liabilities
|
4,932
|
|
|
5,693
|
|
||
Total
|
$
|
6,835
|
|
|
$
|
8,253
|
|
(In thousands)
|
Foreign
currency
translation
|
||
Balance at December 31, 2018
|
$
|
(20,131
|
)
|
Other comprehensive loss before reclassifications
|
(8,643
|
)
|
|
Net other comprehensive loss
|
(8,643
|
)
|
|
Balance at September 30, 2019
|
$
|
(28,774
|
)
|
|
Fair value measurements as of September 30, 2019
|
||||||||||||||
(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:
|
|
|
|
|
|
|
|
||||||||
Equity securities
|
9,129
|
|
|
—
|
|
|
—
|
|
|
9,129
|
|
||||
Common stock options/warrants
|
—
|
|
|
120
|
|
|
—
|
|
|
120
|
|
||||
Forward contracts
|
—
|
|
|
146
|
|
|
—
|
|
|
146
|
|
||||
Total assets
|
$
|
9,129
|
|
|
$
|
266
|
|
|
$
|
—
|
|
|
$
|
9,395
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Contingent consideration
|
—
|
|
|
—
|
|
|
24,459
|
|
|
24,459
|
|
||||
Total liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
24,459
|
|
|
$
|
24,459
|
|
|
Fair value measurements as of December 31, 2018
|
||||||||||||||
(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:
|
|
|
|
|
|
|
|
||||||||
Equity securities
|
26,313
|
|
|
—
|
|
|
—
|
|
|
26,313
|
|
||||
Common stock options/warrants
|
—
|
|
|
855
|
|
|
—
|
|
|
855
|
|
||||
Forward contracts
|
—
|
|
|
21
|
|
|
—
|
|
|
21
|
|
||||
Total assets
|
$
|
26,313
|
|
|
$
|
876
|
|
|
$
|
—
|
|
|
$
|
27,189
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Contingent consideration
|
—
|
|
|
—
|
|
|
24,537
|
|
|
24,537
|
|
||||
Total liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
24,537
|
|
|
$
|
24,537
|
|
|
September 30, 2019
|
||
(In thousands)
|
Contingent
consideration
|
||
Balance at December 31, 2018
|
$
|
24,537
|
|
Change in fair value:
|
|
||
Included in results of operations
|
(78
|
)
|
|
Balance at September 30, 2019
|
$
|
24,459
|
|
(In thousands)
|
Balance Sheet Component
|
|
September 30,
2019 |
|
December 31,
2018 |
||||
Derivative financial instruments:
|
|
|
|
|
|
||||
Common Stock options/warrants
|
Investments, net
|
|
$
|
120
|
|
|
$
|
855
|
|
Forward contracts
|
Unrealized gains on forward contracts are recorded in Other current assets and prepaid expenses. Unrealized (losses) on forward contracts are recorded in Accrued expenses.
|
|
$
|
146
|
|
|
$
|
21
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
(In thousands)
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Derivative gain (loss):
|
|
|
|
|
|
|
|
||||||||
Common Stock options/warrants
|
$
|
(368
|
)
|
|
$
|
(288
|
)
|
|
$
|
(392
|
)
|
|
$
|
3,299
|
|
Forward contracts
|
347
|
|
|
133
|
|
|
398
|
|
|
190
|
|
||||
Total
|
$
|
(21
|
)
|
|
$
|
(155
|
)
|
|
$
|
6
|
|
|
$
|
3,489
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
(In thousands)
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Healthcare insurers
|
$
|
104,020
|
|
|
$
|
123,087
|
|
|
$
|
315,227
|
|
|
$
|
382,778
|
|
Government payers
|
28,206
|
|
|
37,710
|
|
|
87,243
|
|
|
115,881
|
|
||||
Client payers
|
43,750
|
|
|
36,837
|
|
|
120,309
|
|
|
114,666
|
|
||||
Patients
|
5,163
|
|
|
5,177
|
|
|
15,709
|
|
|
16,855
|
|
||||
Total
|
$
|
181,139
|
|
|
$
|
202,811
|
|
|
$
|
538,488
|
|
|
$
|
630,180
|
|
(In thousands)
|
|
Chargebacks, discounts, rebates and fees
|
|
Governmental
|
|
Returns
|
|
Total
|
||||||||
Balance at June 30, 2019
|
|
$
|
1,412
|
|
|
$
|
3,828
|
|
|
$
|
848
|
|
|
$
|
6,088
|
|
Provision related to current period sales
|
|
3,902
|
|
|
7,110
|
|
|
983
|
|
|
11,995
|
|
||||
Adjustment related to prior period sales
|
|
313
|
|
|
(3
|
)
|
|
—
|
|
|
310
|
|
||||
Credits or payments made
|
|
(3,335
|
)
|
|
(4,622
|
)
|
|
(277
|
)
|
|
(8,234
|
)
|
||||
Balance at September 30, 2019
|
|
$
|
2,292
|
|
|
$
|
6,313
|
|
|
$
|
1,554
|
|
|
$
|
10,159
|
|
|
|
|
|
|
|
|
|
|
||||||||
Total gross Rayaldee sales
|
|
|
|
|
|
|
|
$
|
19,661
|
|
||||||
Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales
|
|
|
|
|
|
|
|
63
|
%
|
(In thousands)
|
|
Chargebacks, discounts, rebates and fees
|
|
Governmental
|
|
Returns
|
|
Total
|
||||||||
Balance at December 31, 2018
|
|
$
|
1,316
|
|
|
$
|
2,090
|
|
|
$
|
637
|
|
|
$
|
4,043
|
|
Provision related to current period sales
|
|
8,922
|
|
|
17,009
|
|
|
2,363
|
|
|
28,294
|
|
||||
Adjustment related to prior period sales
|
|
—
|
|
|
99
|
|
|
—
|
|
|
99
|
|
||||
Credits or payments made
|
|
(7,946
|
)
|
|
(12,885
|
)
|
|
(1,446
|
)
|
|
(22,277
|
)
|
||||
Balance at September 30, 2019
|
|
$
|
2,292
|
|
|
$
|
6,313
|
|
|
$
|
1,554
|
|
|
$
|
10,159
|
|
|
|
|
|
|
|
|
|
|
||||||||
Total gross Rayaldee sales
|
|
|
|
|
|
|
|
$
|
47,241
|
|
||||||
Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales
|
|
|
|
|
|
|
|
60
|
%
|
|
For the three months ended September 30,
|
|
For the nine months ended September 30,
|
||||||||||||
(In thousands)
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenue from services:
|
|
|
|
|
|
|
|
||||||||
Pharmaceutical
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Diagnostics
|
181,139
|
|
|
202,811
|
|
|
538,488
|
|
|
630,180
|
|
||||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
181,139
|
|
|
$
|
202,811
|
|
|
$
|
538,488
|
|
|
$
|
630,180
|
|
Revenue from products:
|
|
|
|
|
|
|
|
||||||||
Pharmaceutical
|
$
|
26,161
|
|
|
$
|
25,395
|
|
|
$
|
80,143
|
|
|
$
|
81,769
|
|
Diagnostics
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
26,161
|
|
|
$
|
25,395
|
|
|
$
|
80,143
|
|
|
$
|
81,769
|
|
Revenue from transfer of intellectual property and other:
|
|
|
|
|
|
|
|
||||||||
Pharmaceutical
|
$
|
21,472
|
|
|
$
|
21,609
|
|
|
$
|
58,961
|
|
|
$
|
56,463
|
|
Diagnostics
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
21,472
|
|
|
$
|
21,609
|
|
|
$
|
58,961
|
|
|
$
|
56,463
|
|
Operating loss:
|
|
|
|
|
|
|
|
||||||||
Pharmaceutical
|
$
|
(14,232
|
)
|
|
$
|
(16,937
|
)
|
|
$
|
(52,265
|
)
|
|
$
|
(37,721
|
)
|
Diagnostics
|
(16,363
|
)
|
|
(11,082
|
)
|
|
(77,945
|
)
|
|
(17,624
|
)
|
||||
Corporate
|
(8,416
|
)
|
|
(5,445
|
)
|
|
(31,378
|
)
|
|
(25,839
|
)
|
||||
|
$
|
(39,011
|
)
|
|
$
|
(33,464
|
)
|
|
$
|
(161,588
|
)
|
|
$
|
(81,184
|
)
|
Depreciation and amortization:
|
|
|
|
|
|
|
|
||||||||
Pharmaceutical
|
$
|
7,673
|
|
|
$
|
7,021
|
|
|
$
|
22,580
|
|
|
$
|
20,514
|
|
Diagnostics
|
16,116
|
|
|
16,880
|
|
|
48,647
|
|
|
52,855
|
|
||||
Corporate
|
16
|
|
|
20
|
|
|
54
|
|
|
71
|
|
||||
|
$
|
23,805
|
|
|
$
|
23,921
|
|
|
$
|
71,281
|
|
|
$
|
73,440
|
|
Loss from investment in investees:
|
|
|
|
|
|
|
|
||||||||
Pharmaceutical
|
$
|
(294
|
)
|
|
$
|
(1,603
|
)
|
|
$
|
(2,419
|
)
|
|
$
|
(10,715
|
)
|
Diagnostics
|
—
|
|
|
(271
|
)
|
|
—
|
|
|
(827
|
)
|
||||
Corporate
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
(294
|
)
|
|
$
|
(1,874
|
)
|
|
$
|
(2,419
|
)
|
|
$
|
(11,542
|
)
|
Revenues:
|
|
|
|
|
|
|
|
||||||||
United States
|
$
|
189,485
|
|
|
$
|
208,646
|
|
|
$
|
558,688
|
|
|
$
|
646,492
|
|
Ireland
|
22,968
|
|
|
24,407
|
|
|
65,675
|
|
|
62,468
|
|
||||
Chile
|
8,436
|
|
|
8,926
|
|
|
25,352
|
|
|
32,596
|
|
||||
Spain
|
4,172
|
|
|
4,144
|
|
|
13,466
|
|
|
14,269
|
|
||||
Israel
|
1,938
|
|
|
2,283
|
|
|
8,822
|
|
|
8,424
|
|
||||
Mexico
|
1,642
|
|
|
1,382
|
|
|
5,231
|
|
|
4,105
|
|
||||
Other
|
131
|
|
|
27
|
|
|
358
|
|
|
58
|
|
||||
|
$
|
228,772
|
|
|
$
|
249,815
|
|
|
$
|
677,592
|
|
|
$
|
768,412
|
|
(In thousands)
|
September 30,
2019 |
|
December 31,
2018 |
||||
Assets:
|
|
|
|
||||
Pharmaceutical
|
$
|
1,235,513
|
|
|
$
|
1,236,499
|
|
Diagnostics
|
1,114,485
|
|
|
1,162,160
|
|
||
Corporate
|
19,520
|
|
|
52,413
|
|
||
|
$
|
2,369,518
|
|
|
$
|
2,451,072
|
|
Goodwill:
|
|
|
|
||||
Pharmaceutical
|
$
|
243,011
|
|
|
$
|
247,407
|
|
Diagnostics
|
452,787
|
|
|
452,786
|
|
||
Corporate
|
—
|
|
|
—
|
|
||
|
$
|
695,798
|
|
|
$
|
700,193
|
|
(in thousands)
|
|
Classification on the Balance Sheet
|
|
September 30, 2019
|
||
Assets
|
|
|
|
|
||
Operating lease assets
|
|
Operating lease right-of-use assets
|
|
$
|
35,826
|
|
Finance lease assets
|
|
Property, plant and equipment, net
|
|
7,308
|
|
|
|
|
|
|
|
||
Liabilities
|
|
|
|
|
||
Current
|
|
|
|
|
||
Operating lease liabilities
|
|
Current maturities of operating leases
|
|
12,921
|
|
|
Accrued expenses
|
|
Current maturities of finance leases
|
|
2,983
|
|
|
Long-term
|
|
|
|
|
||
Operating lease liabilities
|
|
Operating lease liabilities
|
|
23,318
|
|
|
Other long-term liabilities
|
|
Finance lease liabilities
|
|
$
|
4,325
|
|
|
|
|
|
|
||
Weighted average remaining lease term
|
|
|
|
|
||
Operating leases
|
|
|
|
2.6 years
|
|
|
Finance leases
|
|
|
|
2.4 years
|
|
|
Weighted average discount rate
|
|
|
|
|
||
Operating leases
|
|
|
|
5.7
|
%
|
|
Finance leases
|
|
|
|
4.9
|
%
|
(in thousands)
|
|
Operating
|
Finance
|
||||
October 1, 2019 through December 31, 2019
|
|
$
|
3,938
|
|
$
|
923
|
|
2020
|
|
11,929
|
|
2,845
|
|
||
2021
|
|
8,471
|
|
2,133
|
|
||
2022
|
|
5,700
|
|
1,077
|
|
||
2023
|
|
4,294
|
|
486
|
|
||
Thereafter
|
|
7,215
|
|
203
|
|
||
Total undiscounted future minimum lease payments
|
|
41,547
|
|
7,667
|
|
||
Less: Difference between lease payments and discounted lease liabilities
|
|
5,308
|
|
360
|
|
||
Total lease liabilities
|
|
$
|
36,239
|
|
$
|
7,307
|
|
(in thousands)
|
|
Nine months ended September 30, 2019
|
||
Operating cash out flows from operating leases
|
|
$
|
15,664
|
|
Operating cash out flows from finance leases
|
|
306
|
|
|
Financing cash out flows from finance leases
|
|
2,165
|
|
|
Total
|
|
$
|
18,135
|
|
Revenues
|
For the three months ended September 30,
|
|
|
||||||||
(In thousands)
|
2019
|
|
2018
|
|
Change
|
||||||
Revenue from services
|
$
|
181,139
|
|
|
$
|
202,811
|
|
|
$
|
(21,672
|
)
|
Revenue from products
|
26,161
|
|
|
25,395
|
|
|
766
|
|
|||
Revenue from transfer of intellectual property and other
|
21,472
|
|
|
21,609
|
|
|
(137
|
)
|
|||
Total revenues
|
$
|
228,772
|
|
|
$
|
249,815
|
|
|
$
|
(21,043
|
)
|
|
Three months ended September 30,
|
||||||
(In thousands)
|
2019
|
|
2018
|
||||
Healthcare insurers
|
$
|
104,020
|
|
|
$
|
123,087
|
|
Government payers
|
28,206
|
|
|
37,710
|
|
||
Client payers
|
43,750
|
|
|
36,837
|
|
||
Patients
|
5,163
|
|
|
5,177
|
|
||
Total
|
$
|
181,139
|
|
|
$
|
202,811
|
|
Cost of Revenue
|
For the three months ended September 30,
|
|
|
|||||||
(In thousands)
|
2019
|
2018
|
|
Change
|
||||||
Cost of service revenue
|
$
|
126,348
|
|
$
|
137,347
|
|
|
$
|
(10,999
|
)
|
Cost of product revenue
|
15,573
|
|
13,609
|
|
|
1,964
|
|
|||
Total cost of revenue
|
$
|
141,921
|
|
$
|
150,956
|
|
|
$
|
(9,035
|
)
|
Research and Development Expenses
|
For the three months ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
External expenses:
|
|
|
|
||||
Manufacturing expense for biological products
|
$
|
12,708
|
|
|
$
|
9,087
|
|
Phase III studies
|
6,862
|
|
|
9,889
|
|
||
Earlier-stage programs
|
1,635
|
|
|
6,848
|
|
||
Research and development employee-related expenses
|
3,745
|
|
|
3,027
|
|
||
Other internal research and development expenses
|
5,067
|
|
|
2,149
|
|
||
Third-party grants and funding from collaboration agreements
|
—
|
|
|
(840
|
)
|
||
Total research and development expenses
|
$
|
30,017
|
|
|
$
|
30,160
|
|
Revenues
|
For the nine months ended September 30,
|
|
|
||||||||
(In thousands)
|
2019
|
|
2018
|
|
Change
|
||||||
Revenue from services
|
$
|
538,488
|
|
|
$
|
630,180
|
|
|
$
|
(91,692
|
)
|
Revenue from products
|
80,143
|
|
|
81,769
|
|
|
(1,626
|
)
|
|||
Revenue from transfer of intellectual property and other
|
58,961
|
|
|
56,463
|
|
|
2,498
|
|
|||
Total revenues
|
$
|
677,592
|
|
|
$
|
768,412
|
|
|
$
|
(90,820
|
)
|
|
For the nine months ended September 30,
|
||||||
(In thousands)
|
2019
|
|
2018
|
||||
Healthcare insurers
|
$
|
315,227
|
|
|
$
|
382,778
|
|
Government payers
|
87,243
|
|
|
115,881
|
|
||
Client payers
|
120,309
|
|
|
114,666
|
|
||
Patients
|
15,709
|
|
|
16,855
|
|
||
Total
|
$
|
538,488
|
|
|
$
|
630,180
|
|
Cost of Revenue
|
For the nine months ended September 30,
|
|
|
|||||||
(In thousands)
|
2019
|
2018
|
|
Change
|
||||||
Cost of service revenue
|
$
|
386,329
|
|
$
|
411,196
|
|
|
$
|
(24,867
|
)
|
Cost of product revenue
|
43,874
|
|
43,909
|
|
|
(35
|
)
|
|||
Total cost of revenue
|
$
|
430,203
|
|
$
|
455,105
|
|
|
$
|
(24,902
|
)
|
Research and Development Expenses
|
For the nine months ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
External expenses:
|
|
|
|
||||
Manufacturing expense for biological products
|
$
|
32,819
|
|
|
$
|
21,028
|
|
Phase III studies
|
17,256
|
|
|
22,149
|
|
||
Earlier-stage programs
|
5,074
|
|
|
14,245
|
|
||
Research and development employee-related expenses
|
18,299
|
|
|
19,683
|
|
||
Other internal research and development expenses
|
21,761
|
|
|
15,993
|
|
||
Third-party grants and funding from collaboration agreements
|
(377
|
)
|
|
(840
|
)
|
||
Total research and development expenses
|
$
|
94,832
|
|
|
$
|
92,258
|
|
Contractual obligations
(In thousands)
|
|
Remaining three months ending December 31, 2019
|
|
2020
|
|
2021
|
|
2022
|
|
2023
|
|
Thereafter
|
|
Total
|
||||||||||||||
Open purchase orders
|
|
$
|
74,836
|
|
|
$
|
2,589
|
|
|
$
|
34
|
|
|
$
|
9
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
77,468
|
|
Operating leases
|
|
3,915
|
|
|
11,491
|
|
|
7,698
|
|
|
4,858
|
|
|
3,447
|
|
|
4,829
|
|
|
36,238
|
|
|||||||
Finance leases
|
|
762
|
|
|
2,729
|
|
|
2,077
|
|
|
1,056
|
|
|
481
|
|
|
203
|
|
|
7,308
|
|
|||||||
2033 Senior Notes, 2025 and 2023 Convertible Notes
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,050
|
|
|
201,260
|
|
|
204,310
|
|
|||||||
Deferred payments
|
|
8,750
|
|
|
7,500
|
|
|
7,500
|
|
|
3,575
|
|
|
—
|
|
|
—
|
|
|
27,325
|
|
|||||||
Mortgages and other debts payable
|
|
747
|
|
|
723
|
|
|
692
|
|
|
490
|
|
|
300
|
|
|
238
|
|
|
3,190
|
|
|||||||
Lines of credit
|
|
5,484
|
|
|
50,644
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
56,128
|
|
|||||||
Interest commitments
|
|
19
|
|
|
662
|
|
|
34
|
|
|
20
|
|
|
317
|
|
|
61,807
|
|
|
62,859
|
|
|||||||
Total
|
|
$
|
94,513
|
|
|
$
|
76,338
|
|
|
$
|
18,035
|
|
|
$
|
10,008
|
|
|
$
|
7,595
|
|
|
$
|
268,337
|
|
|
$
|
474,826
|
|
Exhibit 101.INS
|
Inline XBRL Instance Document
|
Exhibit 101.SCH
|
Inline XBRL Taxonomy Extension Schema Document
|
Exhibit 101.CAL
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
Exhibit 101.DEF
|
Inline XBRL Taxonomy Extension Definition Linkbase Document
|
Exhibit 101.LAB
|
inline XBRL Taxonomy Extension Label Linkbase Document
|
Exhibit 101.PRE
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
*
|
Filed herewith.
|
Date: November 5, 2019
|
|
OPKO Health, Inc.
|
|
|
|
|
|
/s/ Adam Logal
|
|
|
Adam Logal
|
|
|
Senior Vice President, Chief Financial Officer,
|
|
|
Chief Accounting Officer and Treasurer
|
(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: November 5, 2019
|
/s/ Phillip Frost, M.D.
|
|
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: November 5, 2019
|
/s/ Adam Logal
|
|
Adam Logal
|
|
Senior Vice President, Chief Financial Officer,
Chief Accounting Officer and Treasurer
|
Date: November 5, 2019
|
/s/ Phillip Frost, M.D.
|
|
Phillip Frost, M.D.
|
|
Chief Executive Officer
|
Date: November 5, 2019
|
/s/ Adam Logal
|
|
Adam Logal
|
|
Senior Vice President, Chief Financial Officer
Chief Accounting Officer and Treasurer
|