Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number 001-33528 OPKO Health, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of ...

OPKO Health, Inc. Conference Call Summary Company Overview - OPKO Health, Inc. is involved in various projects including diagnostics, licensing agreements, and drug development, particularly in response to pandemic needs [4][6] Key Business Segments Pharmaceutical Division - **Rayaldee**: The only commercial product, sales growth impacted by the pandemic, with optimism for recovery as practices reopen [6] - **Label Expansions**: Plans for trials related to haemodialysis and COVID-19, with enrollment challenges due to vaccination progress [6][7] - **Growth Hormone**: PDUFA date in October for the U.S., with potential significant milestones upon approval and profit-sharing with Pfizer [7][8] Diagnostics Division - **BioReference Laboratories**: A full-service lab with expertise in women's health, oncology, and genetics, significantly increased COVID-19 testing capacity [9][10] - **COVID-19 Testing**: Conducted nearly 16 million tests, with a shift from testing for disease to surveillance testing [21][22] - **Digital Solutions**: Introduction of Scarlet, a home digital solution for lab tests, enhancing convenience and service delivery [17][18] GeneDx - Focused on rare pediatric diseases, showing strong performance post-pandemic with increased demand for genetic testing [11][14] - Partnership with Mednax to enhance NICU testing capabilities, aiming for early diagnosis of genetic abnormalities [14][47] Financial Performance - As of March 31, OPKO had approximately $90 million in cash and $165 million available on credit lines, with four consecutive quarters of operating profit due to COVID testing [12][26] - Guidance for Q2 includes 3 to 4 million COVID tests, projecting revenue between $385 million and $450 million [26] Market Dynamics - The base business is currently about 7% off pre-COVID levels, with expectations for gradual recovery as more people return to offices [17] - Continued interest in large-scale testing for schools and sports franchises, with ongoing discussions for contract renewals [21][24] Future Catalysts - Anticipated launch of Scarlet in more markets, with significant announcements expected in the coming weeks [46] - Potential for GeneDx to expand testing capabilities for a larger population of infants with undiagnosed genetic conditions [47][48] Regulatory and Competitive Landscape - Pfizer controls pricing for the growth hormone, with expectations for a rapid market switch to long-acting formulations [33][40] - Ongoing interactions with regulators as part of the approval process for new products [41] Conclusion - OPKO Health is positioned for growth with a strong focus on digital solutions, expanding diagnostic capabilities, and potential milestones in pharmaceutical products, particularly in the growth hormone market and pediatric genetic testing [48][49]

OPKO Health, Inc. (NASDAQ:OPK) Q1 2021 Earnings Conference Call April 28, 2021 4:30 PM ET Company Participants Yvonne Briggs - LHA Investor Relations Phillip Frost - Chairman & CEO Steven Rubin - EVP, Administration & Director Jon Cohen - SVP & Director Adam Logal - SVP & CFO Antonio Cruz - Chairman & CEO, Transition Therapeutics Inc. Conference Call Participants Maurice Raycroft - Jefferies Dana Flanders - Guggenheim Securities Edward Tenthoff - Piper Sandler & Co. I-Eh Jen - Laidlaw & Company Operator Goo ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number 001-33528 OPKO Health, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction o ...

OPKO Health, Inc. (NASDAQ:OPK) Q4 2020 Earnings Conference Call February 18, 2021 4:30 PM ET Company Participants Yvonne Briggs - LHA IR Phillip Frost - Chairman and CEO Steven Rubin - EVP Jon Cohen - SVP, Executive Chairman, BioReference Laboratories Adam Logal - CFO Charlie Bishop - CEO, OPKO Renal Conference Call Participants Maury Raycroft - Jefferies Devin Geiman - Guggenheim Partners Edward Tenthoff - Piper Sandler Yale Jen - Laidlaw and Company Yi Chen - HCW Mike Petusky - Barrington Research Operato ...

PART I [Item 1. Business](index=6&type=section&id=Item%201.%20Business) OPKO Health is a diversified healthcare company with diagnostics and pharmaceutical segments, leveraging R&D and commercial infrastructure for market expansion - OPKO Health operates in two main segments: diagnostics (BioReference Laboratories, 4Kscore test, point-of-care) and pharmaceuticals (Rayaldee, hGH-CTP Somatrogon, other pipeline products)[17](index=17&type=chunk)[27](index=27&type=chunk) - The company's growth strategy involves leveraging its commercial infrastructure, proprietary technology, and R&D capabilities, including enhancing U.S. and international commercialization, developing Rayaldee for new indications, obtaining regulatory approvals for advanced candidates, and expanding into complementary medical markets[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk)[25](index=25&type=chunk) - Key diagnostic offerings include comprehensive laboratory testing services through BioReference, with a focus on routine and esoteric tests, large-scale COVID-19 screening programs, and the 4Kscore test for aggressive prostate cancer. The company also develops point-of-care diagnostic systems like the Claros Analyzer[28](index=28&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk)[33](index=33&type=chunk)[37](index=37&type=chunk)[44](index=44&type=chunk) - The pharmaceutical business includes Rayaldee for SHPT in CKD patients (FDA approved, launched in 2016), hGH-CTP (Somatrogon) for GHD (Phase 3 completed, BLA submitted to FDA, NDA submitted in Japan), and other pipeline candidates like Alpharen (phosphate binder), OPK88004 (SARM), and OPK88003 (oxyntomodulin for type 2 diabetes/obesity)[17](index=17&type=chunk)[47](index=47&type=chunk)[52](index=52&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk)[64](index=64&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) Research and Development Expenses (2018-2020) | Year Ended December 31, | R&D Expenses (Millions USD) | | :---------------------- | :-------------------------- | | 2020 | $75.3 | | 2019 | $117.9 | | 2018 | $125.6 | [Item 1A. Risk Factors.](index=29&type=section&id=Item%201A.%20Risk%20Factors.) OPKO Health faces significant business, regulatory, and financial risks, including COVID-19 impacts, product development, and compliance challenges - The COVID-19 pandemic has significantly increased demand for the company's COVID-19 testing services, positively impacting operations, but simultaneously caused a decline in core testing business volumes and sales of Rayaldee due to reduced physician visits and elective procedures. The sustainability of COVID-19 testing demand and its impact on overall profitability remain uncertain[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) - OPKO has a history of operating losses and may not achieve sustained profitability, particularly if COVID-19 testing demand declines without a corresponding increase in other revenue streams. The company may require additional funding, which might not be available on favorable terms, or at all, potentially leading to delays or termination of R&D programs[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) - Product development is subject to high failure rates, with risks including ineffectiveness, manufacturing difficulties, uneconomical marketing, infringement of third-party rights, and failure to obtain regulatory approvals. Positive early clinical results are not predictive of future success, and regulatory authorities may impose delays or require additional studies[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk) - The company relies on licensing agreements with VFMCRP and Japan Tobacco for Rayaldee's international development and marketing, and with Pfizer for hGH-CTP (Somatrogon). Failure to maintain these collaborations or their successful commercialization could adversely affect the business and financial condition[172](index=172&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk)[176](index=176&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) - Regulatory compliance is a significant risk, encompassing complex laws related to clinical laboratory operations, drug and device development, billing and payment, data privacy (HIPAA, GDPR), anti-kickback, and false claims. Non-compliance can lead to substantial fines, penalties, litigation, loss of licenses, and exclusion from healthcare programs[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk)[245](index=245&type=chunk)[246](index=246&type=chunk)[247](index=247&type=chunk)[248](index=248&type=chunk)[249](index=249&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk)[255](index=255&type=chunk)[256](index=256&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk)[259](index=259&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk)[263](index=263&type=chunk)[264](index=264&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk)[267](index=267&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk)[270](index=270&type=chunk)[271](index=271&type=chunk)[272](index=272&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk)[275](index=275&type=chunk)[276](index=276&type=chunk)[277](index=277&type=chunk)[278](index=278&type=chunk)[279](index=279&type=chunk) [Item 1B. Unresolved Staff Comments.](index=55&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) The company reported no unresolved staff comments from the SEC - There are no unresolved staff comments[301](index=301&type=chunk) [Item 2. Properties](index=55&type=section&id=Item%202.%20Properties) OPKO Health's principal corporate office is leased in Miami, with significant global properties including laboratories and manufacturing sites - The principal corporate office is located in Miami, Florida, leased from an affiliate of Dr. Phillip Frost, Chairman and CEO[302](index=302&type=chunk) Significant Physical Properties as of December 31, 2020 | Location | Segment and Purpose | Type of Occupancy | | :----------------- | :------------------------------------------------- | :---------------- | | Miami, FL | Diagnostics & Pharmaceutical: Corporate Headquarters | Leased | | Elmwood Park, NJ | Diagnostics: Main Laboratory | Leased | | Gaithersburg, MD | Diagnostics: Genetics Laboratory | Leased | | Kiryat Gat, Israel | Pharmaceutical: Research and Development, CTP | Leased | | Woburn, MA | Diagnostics | Leased | | Nesher, Israel | Pharmaceuticals: API Manufacturing | Leased | | Guadalajara, Mexico| Pharmaceuticals: Pharmaceutical Manufacturing | Owned | | Banyoles, Spain | Pharmaceuticals: Pharmaceutical Manufacturing | Owned | | Palol de Revardit, Spain | Warehouse | Leased | | Barcelona, Spain | Pharmaceuticals: Research and Development | Leased | | Waterford, Ireland | Pharmaceuticals: Pharmaceutical Manufacturing | Leased | | Santiago, Chile | Pharmaceuticals: Office; Warehouse | Leased | [Item 3. Legal Proceedings.](index=55&type=section&id=Item%203.%20Legal%20Proceedings.) OPKO Health has been involved in several legal proceedings, including SEC settlements, class action lawsuits, and a False Claims Act settlement - The SEC filed a lawsuit against OPKO and its CEO, Phillip Frost, in September 2018, alleging securities law violations. OPKO settled in December 2018, agreeing to a **$100,000 penalty** and an injunction from violating Section 13(d) of the Exchange Act[305](index=305&type=chunk) - Class action lawsuits related to the SEC complaint reached a settlement in principle for **$16.5 million**, with a significant portion covered by insurance carriers. A preliminary approval order was entered in September 2020, and final court approval is pending[306](index=306&type=chunk)[311](index=311&type=chunk) - Derivative lawsuits filed against the company were settled for an aggregate of **$3.1 million**, paid by the individual defendants' insurance company, leading to the dismissal of several related actions[307](index=307&type=chunk)[314](index=314&type=chunk)[316](index=316&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk)[319](index=319&type=chunk)[320](index=320&type=chunk)[322](index=322&type=chunk)[323](index=323&type=chunk)[324](index=324&type=chunk) - BioReference Laboratories settled a False Claims Act violation with the U.S. Attorney's Office for the Southern District of New York (SDNY) for approximately **$11.5 million** in September 2020, related to improper billing for clinical laboratory services and physician subsidies for electronic health record systems[703](index=703&type=chunk) - A lawsuit from former shareholders of Claros Diagnostics, Inc. alleging breach of merger agreement for unpaid milestone payments was settled in January 2021 for **$1.1875 million**[326](index=326&type=chunk)[698](index=698&type=chunk) - BioReference is currently undergoing wage and hour investigations by the US Department of Labor and NJ Department of Labor for its Genpath division for 2019 and 2020[327](index=327&type=chunk)[328](index=328&type=chunk) [Item 4. Mine Safety Disclosures.](index=59&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) The company states that this item is not applicable - Item 4. Mine Safety Disclosures is not applicable to the company[329](index=329&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.](index=60&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) OPKO Health's Common Stock trades on NASDAQ and TASE, with no cash dividends anticipated and fluctuating stock performance - OPKO Health, Inc. Common Stock is traded on NASDAQ and the Tel Aviv Stock Exchange under the symbol "OPK"[332](index=332&type=chunk) - As of February 8, 2021, there were approximately **402 holders of record** of the company's Common Stock[332](index=332&type=chunk) - The company has not declared or paid any cash dividends on its Common Stock and does not anticipate paying any in fiscal 2021[333](index=333&type=chunk) Five-Year Cumulative Total Return (Indexed to $100) | | 12/31/2015 | 12/31/2016 | 12/31/2017 | 12/31/2018 | 12/31/2019 | 12/31/2020 | | :--------------------- | :--------- | :--------- | :--------- | :--------- | :--------- | :--------- | | OPKO Health, Inc. | $100.00 | $92.54 | $48.76 | $29.95 | $14.63 | $39.30 | | S&P 500 | 100.00 | 111.96 | 136.40 | 130.42 | 171.49 | 203.04 | | NASDAQ Biotechnology | 100.00 | 78.65 | 95.67 | 87.19 | 109.08 | 137.90 | [Item 6. Selected Financial Data.](index=61&type=section&id=Item%206.%20Selected%20Financial%20Data.) The company states that this item is not applicable - Item 6. Selected Financial Data is not applicable[337](index=337&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=62&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) OPKO Health's 2020 financial performance improved to net income, driven by COVID-19 testing, with analysis of liquidity and critical accounting policies - OPKO Health is a diversified healthcare company with diagnostics (BioReference Laboratories, 4Kscore test) and pharmaceutical (Rayaldee, hGH-CTP Somatrogon) segments, aiming for industry-leading positions in growing medical markets[340](index=340&type=chunk) - In January 2021, the FDA accepted the BLA for Somatrogon for pediatric GHD, with a PDUFA action date in October 2021. A New Drug Application was also submitted in Japan[343](index=343&type=chunk) - COVID-19 testing volumes significantly increased revenue from services by **$545.8 million** in 2020 compared to 2019, but routine clinical and genomics testing volumes declined by **17%** (excluding COVID-19 tests). Sales of Rayaldee also decreased due to the pandemic[347](index=347&type=chunk)[542](index=542&type=chunk) - The company received approximately **$14 million** from the CMS Accelerated and Advance Payment Program and **$16.2 million** from CARES Act funds in 2020, along with deferrals of Social Security taxes and a one-year reprieve from PAMA reporting requirements[349](index=349&type=chunk)[545](index=545&type=chunk) Consolidated Income (Loss) from Operations (2019-2020) | (In thousands) | 2020 | 2019 | Change | % Change | | :------------------------- | :------------ | :------------ | :------------ | :------- | | **Revenues:** | | | | | | Revenue from services | $1,262,242 | $716,434 | $545,808 | 76% | | Revenue from products | $119,952 | $112,184 | $7,768 | 7% | | Revenue from transfer of IP and other | $53,219 | $73,317 | $(20,098) | (27)% | | **Total revenues** | **$1,435,413**| **$901,935** | **$533,478** | **59%** | | **Costs and expenses:** | | | | | | Cost of revenue | $894,408 | $572,484 | $321,924 | 56% | | Selling, general and administrative | $355,573 | $343,305 | $12,268 | 4% | | Research and development | $75,316 | $117,870 | $(42,554) | (36)% | | Contingent consideration | $(3,989) | $(14,854) | $10,865 | (73)% | | Amortization of intangible assets | $56,391 | $64,783 | $(8,392) | (13)% | | Asset impairment charges | $— | $92,399 | $(92,399) | (100)% | | **Total costs and expenses**| **$1,377,699**| **$1,175,987**| **$201,712** | **17%** | | **Income (loss) from operations** | **$57,714** | **$(274,052)**| **$331,766** | **(121)%**| Consolidated Net Income (Loss) and EPS (2018-2020) | Year Ended December 31, | Net Income (Loss) (Thousands USD) | Income (Loss) Per Share | | :---------------------- | :-------------------------------- | :---------------------- | | 2020 | $30,586 | $0.05 | | 2019 | $(314,925) | $(0.53) | | 2018 | $(153,040) | $(0.27) | - Cash and cash equivalents were **$72.2 million** at December 31, 2020. Cash provided by operations was **$39.5 million** in 2020, primarily from diagnostics due to COVID-19 testing. The company anticipates positive cash flow from operations if routine testing normalizes, but the sustainability of COVID-19 related cash flow is uncertain[414](index=414&type=chunk) - Goodwill and other intangible assets totaled **$1.7 billion** at December 31, 2020, subject to annual impairment evaluations. Impairment charges of **$92.4 million** were recognized in 2019, primarily related to OPKO Diagnostics and IPR&D assets, but no impairment charges were recognized in 2020[439](index=439&type=chunk)[445](index=445&type=chunk)[447](index=447&type=chunk)[448](index=448&type=chunk)[552](index=552&type=chunk)[555](index=555&type=chunk)[557](index=557&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures about Market Risk](index=84&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) OPKO Health is exposed to market risks from foreign currency exchange rates and interest rates, with most debt carrying fixed rates - OPKO Health is exposed to foreign currency exchange rate risk due to global operations, with revenues affected by fluctuations in currencies such as the Chilean Peso, Mexican Peso, Euro, and New Israeli Shekel[489](index=489&type=chunk) - The company uses foreign exchange forward contracts to economically hedge inventory purchases against foreign currency risk, but these contracts do not always meet documentation requirements for hedge accounting[490](index=490&type=chunk)[491](index=491&type=chunk) - Interest rate risk is minimal for the company's short-term investment portfolio. Most of its significant debt, including the 2025 Notes (**$200 million** at **4.50%**), 2023 Convertible Notes (**$55 million** at **5%**), and 2033 Senior Notes (**$3 million** at **3%**), carries fixed interest rates, limiting exposure to market interest rate fluctuations[493](index=493&type=chunk)[494](index=494&type=chunk)[495](index=495&type=chunk) Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA [Reports of Independent Registered Certified Public Accounting Firm](index=87&type=section&id=Reports%20of%20Independent%20Registered%20Certified%20Public%20Accounting%20Firm) Ernst & Young LLP issued an unqualified opinion on OPKO Health's financial statements and internal controls, with critical audit matters including goodwill valuation and revenue recognition - Ernst & Young LLP provided an unqualified opinion on OPKO Health's consolidated financial statements for the three years ended December 31, 2020, confirming fair presentation in accordance with U.S. GAAP[500](index=500&type=chunk) - The firm also issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting as of December 31, 2020, based on the COSO criteria[501](index=501&type=chunk)[513](index=513&type=chunk) - Critical audit matters included the complex and highly judgmental valuation of goodwill for the Rayaldee reporting unit, requiring assessment of market and income valuation approaches and significant assumptions[506](index=506&type=chunk) - Another critical audit matter was the estimation of variable consideration in determining revenue from services, which is complex due to billing, reimbursement regulations, and claims processing, necessitating significant auditor judgment[506](index=506&type=chunk)[507](index=507&type=chunk)[508](index=508&type=chunk)[509](index=509&type=chunk) [Consolidated Balance Sheets](index=92&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets show OPKO Health's financial position, with total assets and liabilities increasing in 2020, and a rise in shareholders' equity Consolidated Balance Sheet Highlights (Thousands USD) | Item | December 31, 2020 | December 31, 2019 | | :----------------------------------------- | :---------------- | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | $72,211 | $85,452 | | Accounts receivable, net | $286,314 | $134,617 | | Inventory, net | $132,341 | $53,434 | | Total current assets | $523,179 | $324,045 | | Property, plant and equipment, net | $140,554 | $127,111 | | Intangible assets, net | $475,002 | $528,962 | | In-process research and development | $590,200 | $590,200 | | Goodwill | $680,602 | $671,940 | | Total assets | **$2,473,063** | **$2,309,272** | | **LIABILITIES AND EQUITY** | | | | Accounts payable | $100,883 | $62,537 | | Accrued expenses | $240,869 | $164,925 | | Total current liabilities | $375,483 | $249,119 | | Convertible notes | $221,989 | $211,208 | | Total liabilities | **$801,512** | **$694,513** | | Total shareholders' equity | **$1,671,551** | **$1,614,759** | - Total assets increased by **$163.8 million (7.1%)** from **$2,309.3 million** in 2019 to **$2,473.1 million** in 2020[522](index=522&type=chunk) - Total liabilities increased by **$107.0 million (15.4%)** from **$694.5 million** in 2019 to **$801.5 million** in 2020[522](index=522&type=chunk) - Total shareholders' equity increased by **$56.8 million (3.5%)** from **$1,614.8 million** in 2019 to **$1,671.6 million** in 2020[522](index=522&type=chunk) [Consolidated Statements of Operations](index=93&type=section&id=Consolidated%20Statements%20of%20Operations) The consolidated statements of operations show OPKO Health's significant turnaround to net income in 2020, driven by increased service revenue from COVID-19 testing Consolidated Statements of Operations Highlights (Thousands USD) | Item | 2020 | 2019 | 2018 | | :----------------------------------------- | :------------ | :------------ | :------------ | | **Revenues:** | | | | | Revenue from services | $1,262,242 | $716,434 | $813,248 | | Revenue from products | $119,952 | $112,184 | $107,112 | | Revenue from transfer of IP and other | $53,219 | $73,317 | $69,906 | | **Total revenues** | **$1,435,413**| **$901,935** | **$990,266** | | **Costs and expenses:** | | | | | Cost of service revenue | $823,899 | $511,206 | $546,654 | | Cost of product revenue | $70,509 | $61,278 | $57,982 | | Selling, general and administrative | $355,573 | $343,305 | $358,346 | | Research and development | $75,316 | $117,870 | $125,586 | | Contingent consideration | $(3,989) | $(14,854) | $(16,816) | | Amortization of intangible assets | $56,391 | $64,783 | $67,933 | | Asset impairment charges | $— | $92,399 | $21,778 | | **Total costs and expenses** | **$1,377,699**| **$1,175,987**| **$1,161,463**| | **Operating income (loss)** | **$57,714** | **$(274,052)**| **$(171,197)**| | **Net income (loss)** | **$30,586** | **$(314,925)**| **$(153,040)**| | Income (loss) per share basic and diluted | $0.05 | $(0.53) | $(0.27) | - Total revenues increased by **$533.5 million (59%)** from **$901.9 million** in 2019 to **$1,435.4 million** in 2020, primarily driven by a **76% increase** in revenue from services[525](index=525&type=chunk) - Operating income improved significantly, moving from a loss of **$274.1 million** in 2019 to an income of **$57.7 million** in 2020[525](index=525&type=chunk) - Net income for 2020 was **$30.6 million**, a substantial improvement from a net loss of **$314.9 million** in 2019[525](index=525&type=chunk) [Consolidated Statements of Comprehensive Income (Loss)](index=94&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Income%20(Loss)) The consolidated statements of comprehensive income (loss) show OPKO Health's positive shift to comprehensive income in 2020, driven by net income and foreign currency translation Consolidated Statements of Comprehensive Income (Loss) Highlights (Thousands USD) | Item | 2020 | 2019 | 2018 | | :----------------------------------------- | :------------ | :------------ | :------------ | | Net income (loss) | $30,586 | $(314,925) | $(153,040) | | Other comprehensive income (loss), net of tax: ||| | Change in foreign currency translation and other comprehensive income (loss) | $17,845 | $(1,939) | $(14,727) | | Reclassification adjustments due to adoption of ASU 2016-01 | $— | $— | $(4,876) | | **Comprehensive income (loss)** | **$48,431** | **$(316,864)**| **$(172,643)**| - Comprehensive income for 2020 was **$48.4 million**, a significant increase from a comprehensive loss of **$316.9 million** in 2019[528](index=528&type=chunk) - The change in foreign currency translation and other comprehensive income (loss) was a positive **$17.8 million** in 2020, contrasting with losses in 2019 and 2018[528](index=528&type=chunk) [Consolidated Statements of Equity](index=95&type=section&id=Consolidated%20Statements%20of%20Equity) The consolidated statements of equity reflect an increase in total shareholders' equity in 2020, driven by net income and equity-based compensation Consolidated Statements of Equity Highlights (Thousands USD) | Item | December 31, 2020 | December 31, 2019 | December 31, 2018 | | :----------------------------------------- | :---------------- | :---------------- | :---------------- | | Common Stock (Dollars) | $6,706 | $6,704 | $5,869 | | Additional paid-in capital | $3,152,694 | $3,142,993 | $3,004,422 | | Accumulated other comprehensive loss | $(4,225) | $(22,070) | $(20,131) | | Accumulated deficit | $(1,481,833) | $(1,511,077) | $(1,197,078) | | **Total shareholders' equity** | **$1,671,551** | **$1,614,759** | **$1,791,291** | | Net income (loss) | $30,586 | $(314,925) | $(153,040) | | Equity-based compensation expense | $8,947 | $13,421 | $21,761 | | Sale of common stock | $— | $76,062 | $92,500 | | 2025 convertible notes (equity component) | $— | $50,852 | $— | - Total shareholders' equity increased by **$56.8 million** from **$1,614.8 million** in 2019 to **$1,671.6 million** in 2020[531](index=531&type=chunk) - Accumulated deficit decreased by **$29.2 million** in 2020, reflecting the net income for the year, improving from **$(1,511.1) million** to **$(1,481.8) million**[531](index=531&type=chunk) - Additional paid-in capital increased by **$9.7 million** in 2020, primarily due to equity-based compensation expense and exercise of stock options/warrants[531](index=531&type=chunk) [Consolidated Statements of Cash Flows](index=96&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The consolidated statements of cash flows show OPKO Health generated positive cash from operations in 2020, a significant improvement driven by COVID-19 testing Consolidated Statements of Cash Flows Highlights (Thousands USD) | Item | 2020 | 2019 | 2018 | | :----------------------------------------- | :------------ | :------------ | :------------ | | Net cash provided by (used in) operating activities | $39,476 | $(172,522) | $(109,141) | | Net cash used in investing activities | $(18,327) | $(13,270) | $(26,119) | | Net cash (used in) provided by financing activities | $(35,076) | $175,248 | $140,910 | | Net increase (decrease) in cash and cash equivalents | $(13,241) | $(11,021) | $4,974 | | Cash and cash equivalents at end of period | $72,211 | $85,452 | $96,473 | - Net cash provided by operating activities was **$39.5 million** in 2020, a substantial improvement from net cash used of **$172.5 million** in 2019, primarily due to increased COVID-19 testing volumes[534](index=534&type=chunk) - Cash used in investing activities increased to **$18.3 million** in 2020, mainly due to **$33.7 million** in capital expenditures, partially offset by **$15.1 million** from sales of equity securities[534](index=534&type=chunk) - Net cash used in financing activities was **$35.1 million** in 2020, primarily reflecting net repayments on lines of credit, a shift from cash provided in prior years from stock and convertible note issuances[534](index=534&type=chunk) [Notes to Consolidated Financial Statements](index=98&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The Notes provide detailed disclosures on OPKO Health's business, accounting policies, financial performance, and commitments, crucial for understanding its financial health - OPKO Health is a diversified healthcare company with diagnostics and pharmaceutical segments, operating globally with R&D facilities in Woburn, MA, Waterford, Ireland, Kiryat Gat, Israel, and Barcelona, Spain[536](index=536&type=chunk)[537](index=537&type=chunk)[538](index=538&type=chunk)[539](index=539&type=chunk) - COVID-19 significantly increased 2020 service revenue by **$545.8 million** due to testing volumes, but also caused a **17% decline** in routine clinical and genomics testing and impacted Rayaldee sales. The company received CARES Act benefits, including **$14 million** from CMS and **$16.2 million** in grants[542](index=542&type=chunk)[543](index=543&type=chunk)[544](index=544&type=chunk)[545](index=545&type=chunk) - Goodwill and intangible assets totaled **$1.7 billion** at December 31, 2020. Impairment charges of **$92.4 million** were recorded in 2019, primarily for OPKO Diagnostics and IPR&D assets, but no charges in 2020[552](index=552&type=chunk)[555](index=555&type=chunk)[557](index=557&type=chunk)[558](index=558&type=chunk) - Revenue recognition for services is net of allowances for contractual discounts and implicit price concessions, with **$0.3 million** in positive adjustments in 2020. Product revenue is recognized net of sales deductions and returns, with Rayaldee sales at **$36.8 million** in 2020[573](index=573&type=chunk)[574](index=574&type=chunk)[575](index=575&type=chunk)[576](index=576&type=chunk)[577](index=577&type=chunk)[578](index=578&type=chunk)[711](index=711&type=chunk)[712](index=712&type=chunk)[713](index=713&type=chunk)[714](index=714&type=chunk)[715](index=715&type=chunk)[716](index=716&type=chunk)[717](index=717&type=chunk)[718](index=718&type=chunk)[719](index=719&type=chunk)[720](index=720&type=chunk)[721](index=721&type=chunk)[722](index=722&type=chunk)[723](index=723&type=chunk)[724](index=724&type=chunk)[725](index=725&type=chunk) - Total debt was **$251.2 million** at December 31, 2020, including **$200 million** in **4.50%** Senior Convertible Notes due 2025, **$55 million** in **5%** Convertible Promissory Notes due 2023, and **$3 million** in **3%** Senior Notes due 2033. A **$100 million** unsecured line of credit from an affiliate of Dr. Frost was available but unused[614](index=614&type=chunk)[615](index=615&type=chunk)[624](index=624&type=chunk)[626](index=626&type=chunk)[628](index=628&type=chunk)[110](index=110&type=chunk) - The company reported a net income of **$30.6 million** in 2020, a significant improvement from losses in prior years. Basic and diluted EPS was **$0.05** in 2020[525](index=525&type=chunk) - Equity-based compensation expense was **$8.9 million** in 2020. The company has federal, state, and foreign net operating loss carryforwards totaling **$538.7 million**, **$729.8 million**, and **$78.6 million** respectively, with a full valuation allowance against certain deferred tax assets[579](index=579&type=chunk)[660](index=660&type=chunk)[661](index=661&type=chunk) - Significant legal proceedings include class action and derivative lawsuits related to an SEC complaint (settled for **$16.5 million** and **$3.1 million** respectively), a False Claims Act settlement for **$11.5 million**, and a settlement with Claros Diagnostics shareholders for **$1.1875 million**[699](index=699&type=chunk)[701](index=701&type=chunk)[702](index=702&type=chunk)[703](index=703&type=chunk)[698](index=698&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=141&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's proxy statement - Information for this item is incorporated by reference from the company's definitive proxy statement for the 2020 Annual Meeting of Stockholders[796](index=796&type=chunk) [Item 11. Executive Compensation](index=141&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's definitive proxy statement - Information for this item is incorporated by reference from the company's definitive proxy statement for the 2020 Annual Meeting of Stockholders[796](index=796&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=141&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership and related stockholder matters is incorporated by reference from the company's definitive proxy statement - Information for this item is incorporated by reference from the company's definitive proxy statement for the 2020 Annual Meeting of Stockholders[796](index=796&type=chunk) [Item 13. Certain Relationships and Related Transactions and Director Independence](index=141&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%20and%20Director%20Independence) Information regarding related transactions and director independence is incorporated by reference from the company's definitive proxy statement - Information for this item is incorporated by reference from the company's definitive proxy statement for the 2020 Annual Meeting of Stockholders[796](index=796&type=chunk) [Item 14. Principal Accounting Fees and Services](index=141&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the company's definitive proxy statement - Information for this item is incorporated by reference from the company's definitive proxy statement for the 2020 Annual Meeting of Stockholders[796](index=796&type=chunk) PART IV [Item 15. Exhibits, Financial Statement Schedules.](index=142&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules.) This section lists all exhibits and financial statement schedules filed as part of the 10-K report, including various agreements and certifications - This section provides an index to exhibits, including underwriting agreements, merger agreements, credit agreements, equity incentive plans, and certifications[801](index=801&type=chunk) - Financial statements are located in Part II, Item 8 of the report[801](index=801&type=chunk) - Schedule I – Condensed Financial Information of Registrant is included, while Schedule II – Valuation and Qualifying Accounts is omitted as its information is in the consolidated financial statements[801](index=801&type=chunk) [Signatures](index=160&type=section&id=Signatures) This section contains the required signatures for the 10-K report from key executives and directors, all dated February 18, 2021 - The report is signed by key executives and directors, including Phillip Frost, M.D. (Chairman and CEO), Jane H. Hsiao, Ph.D., MBA (Vice Chairman and CTO), Steven D. Rubin (Director and EVP – Administration), and Adam Logal (SVP, CFO, CAO, and Treasurer)[849](index=849&type=chunk)[850](index=850&type=chunk) - All signatures are dated February 18, 2021[848](index=848&type=chunk)[850](index=850&type=chunk) [Certifications](index=160&type=section&id=Certifications) This section lists the required certifications by the CEO and CFO under the Sarbanes-Oxley Act for the year ended December 31, 2020 - Certifications by the CEO (Phillip Frost) and CFO (Adam Logal) are included, pursuant to Rule 13a-14(a) and 15d-14(a) (Section 302 of Sarbanes-Oxley Act of 2002) and 18 U.S.C. Section 1350 (Section 906 of Sarbanes-Oxley Act of 2002) for the year ended December 31, 2020[807](index=807&type=chunk) [Schedule I - Condensed Financial Information of Registrant](index=152&type=section&id=Schedule%20I%20-%20Condensed%20Financial%20Information%20of%20Registrant) Schedule I presents the parent company's condensed financial statements, included because BioReference's restricted net assets exceed 25% of consolidated net assets - The parent company's condensed financial statements are presented on a stand-alone basis, excluding consolidated subsidiaries[824](index=824&type=chunk) - The schedule is included because BioReference's restricted net assets (**$1.0 billion**) exceed **25%** of OPKO's consolidated net assets (**$2.5 billion**) as of December 31, 2020[825](index=825&type=chunk) Parent Company Condensed Balance Sheet Highlights (Thousands USD) | Item | December 31, 2020 | December 31, 2019 | | :----------------------------------------- | :---------------- | :---------------- | | Cash and cash equivalents | $3,740 | $58,627 | | Total assets | $1,911,260 | $1,854,713 | | Total liabilities | $239,709 | $239,954 | | Total shareholders' equity | $1,671,551 | $1,614,759 | Parent Company Condensed Statements of Income Highlights (Thousands USD) | Item | 2020 | 2019 | 2018 | | :----------------------------------------- | :------------ | :------------ | :------------ | | Total revenues | $1,069 | $1,946 | $1,069 | | Operating loss | $(42,878) | $(49,412) | $(57,870) | | Net income (loss) | $30,586 | $(314,925) | $(153,040) |

OPKO Health, Inc. (NASDAQ:OPK) 39th Annual JPMorgan Virtual Healthcare Conference January 13, 2021 3:40 PM ET Company Participants Phil Frost - Chairman & Chief Executive Officer Steve Rubin - Executive Vice President, Administration & Director Jon Cohen - Senior Vice President & Director Adam Logal - Senior Vice President & Chief Financial Officer Conference Call Participants Phil Frost So we are really pleased to present this year at the JPM conference. The OPKO story has evolved over the last year to the ...

OPKO Health, Inc. (NASDAQ:OPK) Jefferies 2020 Virtual London Healthcare Conference November 18, 2020 10:15 AM ET Company Participants Jon Cohen - Senior Vice President, OPKO Health; Executive Chairman, BioReference Laboratories Adam Logal - Senior Vice President and Chief Financial Officer Steve Rubin - Executive Vice President, Administration Conference Call Participants Maury Raycroft - Jefferies Maury Raycroft Hi, everyone. My name is Maury Raycroft and I am one of the Biotech analysts at Jefferies. Tha ...

OPKO November 2020 NASDAQ: OPK Forward Looking Statements This presentation contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "potential," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the mar ...

OPKO Forward Looking Statements This presentation contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "potential," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our p ...