MIAMI, May 03, 2024 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended March 31, 2024 after the close of the U.S. financial markets on Tuesday, May 7, 2024. OPKO's senior management will provide a business update and discuss results as well as financial guidance during a conference call and live audio webcast on May 7th beginning at 4:30 p.m. Eastern time. CONFERENCE CALL & WEBCAST INFORMATION OPKO encourages participants to pre-regi ...

Part I [Business](index=8&type=section&id=Item%201.%20Business) OPKO Health, Inc. is a diversified healthcare company operating in pharmaceutical and diagnostic segments, featuring products like Rayaldee® and NGENLA®, and diagnostic services through BioReference Health [Overview](index=8&type=section&id=Overview) OPKO Health is a diversified healthcare company with leading pharmaceutical products like Rayaldee® and NGENLA®, complemented by its BioReference diagnostics business and international pharmaceutical platforms - The company operates through two main business segments: pharmaceuticals and diagnostics[20](index=20&type=chunk)[22](index=22&type=chunk) - Key pharmaceutical products are Rayaldee® (for SHPT in CKD) and NGENLA® (Somatrogon, a once-weekly human growth hormone), which is partnered with Pfizer and approved in over **50 markets** including the U.S., EU, and Japan[20](index=20&type=chunk) - In May 2022, OPKO acquired ModeX Therapeutics to expand its pharmaceutical pipeline with multi-specific immune therapies for cancer and infectious diseases[21](index=21&type=chunk) - The diagnostics business is primarily BioReference Health, one of the largest full-service laboratories in the U.S., offering a comprehensive test menu and the proprietary 4Kscore® prostate cancer test[22](index=22&type=chunk) - OPKO has established revenue-generating pharmaceutical platforms in Spain, Ireland, Chile, and Mexico, along with a specialty API manufacturer in Israel[23](index=23&type=chunk) [Growth Strategy](index=8&type=section&id=Growth%20Strategy) OPKO's growth strategy centers on expanding its next-generation therapy portfolio through enhanced commercialization, regulatory approvals, market expansion, and leveraging the ModeX acquisition for pipeline growth - Continue marketing and commercialization of Rayaldee, with potential label expansion[32](index=32&type=chunk) - Support Pfizer's efforts to seek approval for additional indications for NGENLA® (Somatrogon), including adult growth hormone deficiency[32](index=32&type=chunk) - Leverage the acquisition of ModeX to expand the pharmaceutical product line, utilizing its MSTAR platform for multispecific antibodies and vaccines against cancer and infectious diseases[28](index=28&type=chunk) - Continue to commercialize and increase adoption of the 4Kscore® test for prostate cancer through BioReference[29](index=29&type=chunk) [Current Products and Services](index=10&type=section&id=Current%20Products%20and%20Services) OPKO offers comprehensive diagnostic services through BioReference, including the 4Kscore® test, and commercial pharmaceutical products like Rayaldee® and NGENLA®, alongside a pipeline of novel therapies - BioReference, a top U.S. lab, offers comprehensive testing services and reached approximately **9 million patients** in 2023[34](index=34&type=chunk)[39](index=39&type=chunk) - The 4Kscore® test, for assessing aggressive prostate cancer risk, was FDA-approved in December 2021 and has a Category I CPT® code to facilitate reimbursement[42](index=42&type=chunk)[46](index=46&type=chunk) - Rayaldee® prescriptions increased by **13.6%** in Q4 2023 compared to Q4 2022. The product has secured unrestricted access for **63% of commercial** and **71% of Medicare Part D** covered lives[52](index=52&type=chunk) - NGENLA® (Somatrogon), partnered with Pfizer, is a once-weekly human growth hormone approved in over **50 markets**, including a June 2023 FDA approval for pediatric GHD[79](index=79&type=chunk)[82](index=82&type=chunk) - The ModeX acquisition brought a pipeline of multispecific antibodies and vaccines, including a tetra-specific antibody for solid tumors expected to enter clinical testing in 2024 and an EBV vaccine candidate licensed to Merck[62](index=62&type=chunk)[66](index=66&type=chunk) [Intellectual Property](index=21&type=section&id=Intellectual%20Property) OPKO protects its key products like Rayaldee® and NGENLA®, along with its pipeline, through a robust portfolio of owned and licensed U.S. and foreign patents and applications - Rayaldee is protected by multiple U.S. patent families, with expirations in **2027 and 2028**, and additional pending applications extending to **2034**[102](index=102&type=chunk) - The NGENLA® (Somatrogon) patent estate, exclusively licensed to Pfizer, includes patents covering the modified hormone, its uses, and manufacturing methods, with core patents expiring in **2027/2028** and formulation patents pending until **2033**[103](index=103&type=chunk) - OPK88003 (oxyntomodulin) is covered by a U.S. patent expiring in December **2030**, while OPK88004 (SARM) is covered by a patent expiring in November **2027**[104](index=104&type=chunk) - ModeX Therapeutics has multiple patents and applications, both owned and licensed (e.g., from Sanofi), covering its vaccine candidates (like the EBV vaccine out-licensed to Merck) and multispecific antibodies for infectious disease and cancer[106](index=106&type=chunk) [Competition](index=24&type=section&id=Competition) OPKO operates in highly competitive pharmaceutical and diagnostic markets, facing larger competitors for products like Rayaldee® and NGENLA®, and for its BioReference laboratory services - Competitors include major pharmaceutical, specialty pharma, and biotech companies with substantially greater financial and operational resources[110](index=110&type=chunk) - Rayaldee's competition includes activated vitamin D analogs (calcitriol, doxercalciferol) and vitamin D supplements[111](index=111&type=chunk) - NGENLA® (hGH-CTP) competes with other long-acting hGH products and numerous generic daily human growth hormone products[112](index=112&type=chunk) - In clinical laboratory operations, major competitors are Quest Diagnostics and Laboratory Corporation of America[113](index=113&type=chunk) [Government Regulation](index=25&type=section&id=Government%20Regulation) OPKO's operations are subject to extensive U.S. and international regulations, including FDA drug approval processes, CLIA standards for labs, and laws governing billing, data privacy, and fraud and abuse - Clinical laboratory operations are regulated under the Clinical Laboratory Improvement Amendments (CLIA) to ensure quality and reliability, requiring certification and periodic inspections[117](index=117&type=chunk) - Drug development is a multi-year process requiring preclinical studies and three phases of clinical trials to establish safety and efficacy before an NDA or BLA can be submitted to the FDA for approval[119](index=119&type=chunk)[121](index=121&type=chunk) - The company is subject to data privacy and security regulations, including HIPAA in the U.S. and the General Data Protection Regulation (GDPR) in Europe[140](index=140&type=chunk)[142](index=142&type=chunk) - Operations must comply with healthcare fraud and abuse laws, including the Anti-Kickback Statute, the Stark Law (physician self-referral), and the False Claims Act[143](index=143&type=chunk)[145](index=145&type=chunk)[148](index=148&type=chunk) [Human Capital Resources](index=34&type=section&id=Human%20Capital%20Resources) As of December 31, 2023, OPKO employed 3,930 full-time staff globally, prioritizing employee safety, competitive compensation, diversity, and talent development - As of December 31, 2023, the company had **3,930 full-time employees** worldwide[156](index=156&type=chunk) - The company emphasizes employee safety, complying with CLIA and OSHA regulations, and has implemented measures to address risks such as the COVID-19 pandemic[157](index=157&type=chunk) - OPKO is committed to diversity and inclusion, competitive pay and benefits, and talent development to strengthen employee retention[158](index=158&type=chunk)[159](index=159&type=chunk)[161](index=161&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) OPKO faces significant risks including historical operating losses, funding needs, R&D uncertainties, intense competition, regulatory hurdles, intellectual property challenges, and dependence on key products and leadership - The company has a history of operating losses and may require additional funding, which may not be available on acceptable terms[165](index=165&type=chunk)[167](index=167&type=chunk) - Business success is substantially dependent on generating profits from laboratory operations and the successful commercialization of NGENLA® (in partnership with Pfizer) and Rayaldee®[179](index=179&type=chunk)[186](index=186&type=chunk) - The company faces risks from intense competition, potential failure of R&D to produce viable products, and the possibility that clinical trial results may not be predictive of future success[171](index=171&type=chunk)[191](index=191&type=chunk) - Regulatory risks are significant, including failure to obtain or maintain approvals from the FDA and other authorities, and compliance with complex laws like CLIA, HIPAA, and anti-kickback statutes[258](index=258&type=chunk)[261](index=261&type=chunk)[273](index=273&type=chunk) - Intellectual property risks include the inability to obtain and enforce patent protection, which could materially harm the business[233](index=233&type=chunk) - International operations are subject to risks including currency fluctuations, political instability in regions like Israel, and compliance with the Foreign Corrupt Practices Act (FCPA)[296](index=296&type=chunk)[297](index=297&type=chunk)[298](index=298&type=chunk) - The company's success is significantly dependent on the involvement and reputation of its Chairman and CEO, Dr. Phillip Frost[211](index=211&type=chunk) [Unresolved Staff Comments](index=72&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that there are no unresolved staff comments - None[315](index=315&type=chunk) [Cybersecurity](index=72&type=section&id=Item%201C.%20Cybersecurity) OPKO maintains a comprehensive cybersecurity risk management program with Board oversight, technical safeguards, and incident response, reporting no material breaches affecting its operations - The Audit Committee of the Board has direct oversight of cybersecurity risks, receiving regular reports from the Chief Compliance & Audit Officer (CCO/CAO) and Chief Information Security Officer (CISO)[319](index=319&type=chunk) - The company's risk management strategy includes regular risk assessments, technical safeguards, incident response plans, third-party risk management, and employee training[319](index=319&type=chunk) - OPKO maintains industry certifications such as SOC 2 Type 2 and PCI DSS attestations and conducts annual vulnerability and penetration tests[319](index=319&type=chunk) - As of the filing date, the company reports no material breaches or cybersecurity incidents that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[319](index=319&type=chunk) [Properties](index=74&type=section&id=Item%202.%20Properties) OPKO's properties include leased corporate offices in Miami, owned manufacturing facilities in Mexico and Spain, and leased R&D and diagnostic labs globally Property Locations | Location | Segment and Purpose | Type of Occupancy | | :--- | :--- | :--- | | Miami, FL | Diagnostics & Pharmaceutical: Corporate Headquarters | Leased | | Elmwood Park, NJ | Diagnostics: Main Laboratory | Leased | | Kiryat Gat, Israel | Pharmaceutical: Research and Development, CTP | Leased | | Nesher, Israel | Pharmaceuticals: API Manufacturing | Leased | | Guadalajara, Mexico | Pharmaceuticals: Pharmaceutical Manufacturing | Owned | | Banyoles, Spain | Pharmaceuticals: Pharmaceutical Manufacturing | Owned | | Waterford, Ireland | Pharmaceuticals: Pharmaceutical Manufacturing | Leased | [Legal Proceedings](index=74&type=section&id=Item%203.%20Legal%20Proceedings) OPKO is involved in legal proceedings including a potential Texas Medicaid fraud violation, a $246 million Israel tax assessment, and a recently dismissed False Claims Act case - In February 2023, the Texas Attorney General's Office notified BioReference of a potential violation of the Texas Medicaid Fraud Prevention Act, with potential liability yet to be determined[327](index=327&type=chunk) - On December 29, 2022, the Israel Tax Authority issued a tax assessment of approximately **$246 million** (including interest) against OPKO Biologics for tax years 2014-2020, which the company is appealing[328](index=328&type=chunk) - A Civil Investigative Demand from the U.S. Department of Justice related to the False Claims Act and Anti-Kickback Statute, which led to a relator's complaint, was dismissed with prejudice on January 23, 2024[329](index=329&type=chunk) [Mine Safety Disclosures](index=74&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[330](index=330&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=76&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) OPKO's common stock trades on NASDAQ and the Tel Aviv Stock Exchange, with no cash dividends paid or anticipated, and no share repurchases in Q4 2023 - The company's common stock trades on NASDAQ and the Tel Aviv Stock Exchange under the ticker "**OPK**"[333](index=333&type=chunk) - No cash dividends have been declared or paid, and none are anticipated for fiscal 2024[334](index=334&type=chunk) - No shares of common stock were repurchased during the fourth quarter of the year ended December 31, 2023[334](index=334&type=chunk) [Selected Financial Data](index=77&type=section&id=Item%206.%20%5BReserved.%5D) This item is not applicable - Not applicable[339](index=339&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=78&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) OPKO reported an improved operating loss in FY2023 on decreased total revenues, driven by lower diagnostics services but offset by increased pharmaceutical revenue and bolstered liquidity from recent financing [Results of Operations](index=79&type=section&id=Results%20of%20Operations) In 2023, OPKO improved its operating loss to $157.0 million despite a 14% revenue decrease, driven by a 32% decline in diagnostics offset by a 40% pharmaceutical revenue increase Consolidated Statements of Operations Data | (In thousands) | 2023 | 2022 | % Change | | :--- | :--- | :--- | :--- | | **Total revenues** | $863,495 | $1,004,196 | (14)% | | Revenue from services | $515,275 | $755,630 | (32)% | | Revenue from products | $167,557 | $142,845 | 17% | | Revenue from transfer of IP | $180,663 | $105,721 | 71% | | **Total costs and expenses** | $1,020,515 | $1,230,449 | (17)% | | **Loss from operations** | ($157,020) | ($226,253) | 31% | - The Diagnostics segment's revenue from services decreased by **32%** in 2023, primarily due to a **$189.7 million** reduction in COVID-19 testing demand and lower reimbursement[348](index=348&type=chunk) - The Pharmaceuticals segment's total revenue increased by **40%** in 2023, driven by a **$90.0 million** milestone from Pfizer for NGENLA®'s FDA approval, a **$50.0 million** upfront payment from Merck, and a **14% increase** in Rayaldee sales to **$31.0 million**[357](index=357&type=chunk)[358](index=358&type=chunk) - Research and development expenses increased **21%** in 2023 to **$89.6 million**, mainly due to increased activity at ModeX, including a **$12.5 million** payment to Sanofi[347](index=347&type=chunk)[362](index=362&type=chunk) [Liquidity and Capital Resources](index=90&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2023, OPKO held $95.9 million in cash, with liquidity significantly bolstered in January 2024 by a $230.0 million convertible notes offering and strategic debt repurchases - The company held **$95.9 million** in cash and cash equivalents as of December 31, 2023[402](index=402&type=chunk) - In January 2024, OPKO completed a private offering of **$230.0 million** of 3.75% Convertible Senior Notes due 2029, receiving net proceeds of approximately **$222.0 million**[403](index=403&type=chunk)[404](index=404&type=chunk) - Proceeds from the 2024 note offering were used to repurchase approximately **$144.4 million** of existing 2025 notes for **$146.3 million** and to repurchase **$50.0 million** of the company's common stock[404](index=404&type=chunk)[405](index=405&type=chunk) - In 2023, the company received significant cash inflows from milestone payments, including **$90.0 million** from Pfizer for NGENLA®'s FDA approval and a **$50.0 million** upfront payment from Merck[411](index=411&type=chunk)[412](index=412&type=chunk) - As of December 31, 2023, the company had **$37.9 million** in total commitments under its credit facilities, with **$25.3 million** drawn[421](index=421&type=chunk) [Critical Accounting Policies and Estimates](index=97&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Management's critical accounting policies involve significant estimates for goodwill and intangible asset impairment, complex revenue recognition for services and products, and fair value measurement of contingent consideration - Goodwill and intangible assets are tested for impairment annually or when indicators are present. The fair value estimation is highly sensitive to changes in projections and assumptions. The combined goodwill of the diagnostics segment and Ireland reporting unit was **$367.3 million** at year-end 2023[432](index=432&type=chunk)[434](index=434&type=chunk)[438](index=438&type=chunk) - Revenue from laboratory services is recognized net of variable consideration, including contractual allowances and implicit price concessions. In 2023, negative revenue adjustments of **$19.2 million** were recognized for performance obligations from prior periods[442](index=442&type=chunk)[447](index=447&type=chunk) - Revenue from product sales, like Rayaldee, is recorded net of estimated Sales Deductions (rebates, chargebacks, discounts) and product returns. For 2023, the provision for these deductions was **54%** of gross Rayaldee sales[451](index=451&type=chunk)[708](index=708&type=chunk) - Revenue from intellectual property involves estimating variable consideration for milestones and constraining it until achievement is probable and a significant reversal is not expected[456](index=456&type=chunk)[458](index=458&type=chunk) - Contingent consideration from acquisitions is revalued each period, and changes in fair value are recorded in earnings. These estimates are subject to significant judgment regarding milestone achievement and timing[472](index=472&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=105&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) OPKO faces market risks from foreign currency fluctuations, with 29.6% of 2023 revenue in non-USD currencies, and interest rate changes on its variable-rate debt and cash portfolio - In 2023, **29.6%** of revenue was denominated in currencies other than the U.S. Dollar, primarily the Euro and Chilean Peso, exposing the company to foreign exchange risk[483](index=483&type=chunk) - The company uses foreign exchange forward contracts to manage currency risk. As of December 31, 2023, it had **52 open contracts** with a total notional value of approximately **$2.9 million**[346](index=346&type=chunk) - Interest rate risk is related to cash and investments, and variable-rate borrowings. As of December 31, 2023, the company had **$25.3 million** in outstanding variable-rate debt at a weighted average interest rate of **7.52%**[485](index=485&type=chunk) - Outstanding convertible senior and senior notes have fixed interest rates, which limits interest rate risk on those specific debt instruments[486](index=486&type=chunk) [Financial Statements and Supplementary Data](index=107&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents OPKO's audited consolidated financial statements for FY2023, including balance sheets, income statements, and cash flows, with an unqualified opinion from Ernst & Young LLP Consolidated Balance Sheets | (In thousands) | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | $2,011,698 | $2,167,259 | | Cash and cash equivalents | $95,881 | $153,191 | | Goodwill & Intangibles | $1,533,543 | $1,614,371 | | **Total Liabilities** | $622,479 | $605,611 | | Convertible notes | $214,325 | $210,371 | | **Total Shareholders' Equity** | $1,389,219 | $1,561,648 | Consolidated Statements of Operations | (In thousands, except per share data) | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | **Total revenues** | $863,495 | $1,004,196 | $1,774,718 | | **Operating income (loss)** | ($157,021) | ($226,253) | $18,750 | | **Net loss** | ($188,863) | ($328,405) | ($30,143) | | **Loss per share basic and diluted** | ($0.25) | ($0.46) | ($0.05) | Consolidated Statements of Cash Flows | (In thousands) | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | **Net cash (used in) provided by operating activities** | ($28,197) | ($95,189) | $38,337 | | **Net cash (used in) provided by investing activities** | ($18,198) | $91,038 | $35,949 | | **Net cash (used in) provided by financing activities** | ($11,303) | $22,971 | ($10,350) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=175&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[790](index=790&type=chunk) [Controls and Procedures](index=175&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with an unqualified audit opinion from Ernst & Young LLP - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[791](index=791&type=chunk) - Based on the COSO framework, management concluded that internal control over financial reporting was effective as of December 31, 2023[793](index=793&type=chunk) - The company's independent auditor, Ernst & Young LLP, issued an unqualified opinion on the effectiveness of internal control over financial reporting as of December 31, 2023[794](index=794&type=chunk) [Other Information](index=175&type=section&id=Item%209B.%20Other%20Information) No officers or directors adopted or terminated Rule 10b5-1 trading plans during the fourth quarter ended December 31, 2023 - No officers or directors adopted or terminated Rule 10b5-1 trading plans during the fourth quarter ended December 31, 2023[796](index=796&type=chunk) [Disclosure regarding Foreign Jurisdictions that Prevent Inspections](index=175&type=section&id=Item%209C.%20Disclosure%20regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[797](index=797&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, Certain Relationships and Related Transactions, and Principal Accounting Fees and Services](index=176&type=section&id=Items%2010%2C%2011%2C%2012%2C%2013%2C%20and%2014) Information for Items 10 through 14 is incorporated by reference from the company's forthcoming definitive proxy statement for its 2024 Annual Meeting of Stockholders - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the forthcoming 2024 proxy statement[799](index=799&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=177&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section provides an index of all financial statements, schedules, and exhibits filed as part of the Form 10-K, including various agreements and certifications - This section provides an index of all exhibits filed with the Form 10-K, including material contracts, indentures, and certifications[801](index=801&type=chunk)[802](index=802&type=chunk) [Form 10-K Summary](index=182&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports that there is no Form 10-K summary - None[810](index=810&type=chunk)

Conference call begins at 4:30 p.m. Eastern time today MIAMI (February 27, 2024) – OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three and 12 months ended December 31, 2023. Business highlights from the fourth quarter and subsequent weeks included the following: ● ModeX advanced its antiviral and immune-oncology product pipeline. ModeX advanced its pipeline of antiviral and immune-oncology programs utilizing its next-generation multispecific antibodies, with expec ...

MIAMI, Jan. 04, 2024 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) (the "Company") today announced the pricing of its private offering of $200.0 million aggregate principal amount of its Convertible Senior Notes due 2029 (the "Notes"). The Company granted the initial purchaser in the offering an option to purchase, within the 13-day period beginning on, and including, the date on which the Notes are first issued, up to an additional $30.0 million aggregate principal amount of the Notes. The sale of the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Table of Contents (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023. 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) Delaware 75-2402409 (State o ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q For the transition period from to . Commission file number 001-33528 OPKO Health, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 75-2402409 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) (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, 2023. OR ☐TR ...

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) OPKO Health reported **$237.6 million** in Q1 2023 total revenues and a net loss of **$18.3 million**, an improvement from the prior year's **$55.4 million** net loss, with **$2.17 billion** in total assets [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets reached **$2.17 billion** as of March 31, 2023, with cash at **$110.8 million** and total liabilities at **$617.9 million** Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $110,830 | $153,191 | | Total current assets | $406,418 | $394,525 | | Goodwill | $597,380 | $595,851 | | Intangible assets, net | $803,616 | $823,520 | | **Total assets** | **$2,169,670** | **$2,167,259** | | **Liabilities & Equity** | | | | Total current liabilities | $222,422 | $213,480 | | Long term portion of convertible notes | $211,328 | $210,371 | | **Total liabilities** | **$617,860** | **$605,611** | | **Total shareholders' equity** | **$1,551,810** | **$1,561,648** | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2023 total revenues declined to **$237.6 million**, but operating loss narrowed to **$30.6 million** and net loss improved to **$18.3 million** Q1 2023 vs Q1 2022 Statement of Operations (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Revenue from services | $132,368 | $286,599 | | Revenue from products | $40,383 | $36,658 | | Revenue from transfer of intellectual property | $64,826 | $5,962 | | **Total revenues** | **$237,577** | **$329,219** | | Total costs and expenses | $268,171 | $401,643 | | **Operating loss** | **$(30,594)** | **$(72,424)** | | **Net loss** | **$(18,267)** | **$(55,433)** | | **Loss per share** | **$(0.02)** | **$(0.08)** | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating activities used **$22.6 million** in Q1 2023, leading to a **$42.4 million** net decrease in cash, ending at **$110.8 million** Q1 2023 vs Q1 2022 Cash Flows (in thousands) | Cash Flow Activity | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(22,647) | $(19,856) | | Net cash used in investing activities | $(7,717) | $(4,903) | | Net cash used in financing activities | $(13,119) | $(7,891) | | **Net decrease in cash and cash equivalents** | **$(42,361)** | **$(32,429)** | | **Cash and cash equivalents at end of period** | **$110,830** | **$102,281** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail business structure, key transactions, and accounting policies, including a **$50 million** Merck alliance and a **$246 million** tax assessment - Revenue from services for Q1 2023 decreased by **$154.2 million** compared to Q1 2022, driven by lower COVID-19 testing volumes, but routine clinical test volume increased by **6.8%** excluding COVID-19 tests[39](index=39&type=chunk) - In March 2023, ModeX entered a license and research collaboration with Merck for an Epstein Barr Virus vaccine candidate, receiving a **$50.0 million** upfront payment and eligibility for up to **$872.5 million** in milestones[191](index=191&type=chunk)[192](index=192&type=chunk) - The Israel Tax Authority (ITA) issued an assessment of approximately **$246 million** (including interest) against OPKO Biologics for tax years 2014-2020, which the company is appealing[156](index=156&type=chunk) - In February 2023, the company amended its **$55.0 million** 5% Convertible Promissory Notes, extending maturity to January 31, 2025, and resetting the conversion price to **$1.66**[122](index=122&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Consolidated revenue declined **28%** due to lower COVID-19 testing, but operating loss improved to **$30.6 million** driven by intellectual property revenue [Results of Operations](index=47&type=section&id=Results%20of%20Operations) Q1 2023 operating loss improved to **$30.6 million**, with Diagnostics revenue down **54%** and Pharmaceuticals revenue up **147%** Segment Operating Income (Loss) (in thousands) | Segment | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Pharmaceutical | $18,955 | $(18,108) | | Diagnostics | $(40,007) | $(43,548) | | Corporate | $(9,542) | $(10,768) | | **Total Operating Loss** | **$(30,594)** | **$(72,424)** | - Diagnostics revenue decreased by **$154.2 million**, primarily due to lower demand and reimbursement for COVID-19 testing, with BioReference performing only **68,000** molecular COVID-19 tests in Q1 2023 compared to **1,981,000** in Q1 2022[248](index=248&type=chunk) - Pharmaceuticals revenue from transfer of intellectual property increased to **$64.8 million** from **$6.0 million**, mainly due to a **$50.0 million** upfront payment from Merck and a **$7.0 million** milestone from Vifor[257](index=257&type=chunk) - Pharmaceutical R&D expenses increased to **$31.9 million** from **$12.3 million**, primarily due to a **$12.5 million** payment to Sanofi related to the Merck collaboration[261](index=261&type=chunk) [Liquidity and Capital Resources](index=53&type=section&id=Liquidity%20and%20Capital%20Resources) Q1 2023 ended with **$110.8 million** in cash, supported by a **$50 million** Merck payment, ensuring sufficient liquidity for the next 12 months - As of March 31, 2023, the company had cash and cash equivalents of **$110.8 million**[272](index=272&type=chunk) - A one-time, non-refundable upfront payment of **$50.0 million** from Merck was received in April 2023[273](index=273&type=chunk) - The company believes its cash on hand and available credit lines are sufficient to meet anticipated cash requirements for operations and debt service beyond the next 12 months[286](index=286&type=chunk) Known Contractual Obligations as of March 31, 2023 (in thousands) | Obligation Type | Total | Due in < 1 Year | Due in 1-3 Years | Due in 3-5 Years | Due Thereafter | | :--- | :--- | :--- | :--- | :--- | :--- | | 2025 and 2023 Convertible Notes | $211,328 | $0 | $211,328 | $0 | $0 | | Lines of credit | $22,259 | $22,259 | $0 | $0 | $0 | | Operating leases | $37,952 | $9,041 | $12,722 | $6,728 | $9,461 | | Open purchase orders | $52,809 | $52,568 | $241 | $0 | $0 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from foreign currency fluctuations, primarily Euro and Chilean Peso, and interest rate changes on variable-rate borrowings - The company is subject to foreign exchange risk, with approximately **18.5%** of Q1 2023 revenue denominated in currencies other than the U.S. Dollar, primarily the Euro and Chilean Peso[300](index=300&type=chunk) - Interest rate risk exposure relates to cash and investments and variable-rate borrowings, with **$22.3 million** outstanding under lines of credit at a weighted average interest rate of approximately **5.4%** as of March 31, 2023[302](index=302&type=chunk) - The company's **$55.0 million** 2023 Convertible Notes (**5%** fixed rate) and **$200.0 million** 2025 Notes (**4.50%** fixed rate) are not subject to fluctuations in market interest rates[303](index=303&type=chunk) [Item 4. Controls and Procedures](index=60&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal controls - Based on an evaluation as of the end of the period, management concluded that the company's disclosure controls and procedures were effective[306](index=306&type=chunk) - No changes occurred during the quarter ended March 31, 2023, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[307](index=307&type=chunk) [PART II. OTHER INFORMATION](index=61&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=61&type=section&id=Item%201.%20Legal%20Proceedings) BioReference was informed by the Texas Attorney General's office of potential Medicaid Fraud Prevention Act violations - In February 2023, the Texas Attorney General's office informed BioReference of potential violations of the Texas Medicaid Fraud Prevention Act regarding claims presented to Texas Medicaid for reimbursement from 2005 to February 2023[310](index=310&type=chunk) - The company cannot currently predict the outcome or determine the extent of any potential liability for the Texas OAG matter[310](index=310&type=chunk) [Item 1A. Risk Factors](index=62&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported from the 2022 Annual Report on Form 10-K - There have been no material changes to risk factors previously disclosed in the 2022 Annual Report on Form 10-K[313](index=313&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=62&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported [Item 3. Defaults Upon Senior Securities](index=62&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported [Item 5. Other Information](index=62&type=section&id=Item%205.%20Other%20Information) No other information was reported [Item 6. Exhibits](index=62&type=section&id=Item%206.%20Exhibits) Key exhibits include the License and Research Collaboration Agreement with Merck and certifications by the CEO and CFO - A key exhibit filed is the License and Research Collaboration Agreement between ModeX Therapeutics, Inc., OPKO Health, Inc., and Merck Sharp & Dohme LLC, dated March 7, 2023[318](index=318&type=chunk)

[Part I](index=7&type=section&id=Part%20I) [Business](index=7&type=section&id=Item%201.%20Business) OPKO Health is a diversified healthcare company with Diagnostics and Pharmaceuticals segments, focusing on product development and international expansion [Overview](index=7&type=section&id=OVERVIEW) - OPKO is a diversified healthcare company with a diagnostics business (BioReference Laboratories) and a pharmaceutical business (Rayaldee®, Somatrogon)[20](index=20&type=chunk) - The diagnostics arm, BioReference, is one of the largest full-service laboratories in the U.S., offering a comprehensive test menu including the **4Kscore® prostate cancer test**[20](index=20&type=chunk)[21](index=21&type=chunk) - The pharmaceutical arm features Rayaldee® for SHPT in CKD patients and Somatrogon (NGENLA®), a once-weekly human growth hormone partnered with Pfizer, which has received marketing authorization in the EU, Japan, Canada, and Australia[20](index=20&type=chunk) - In May 2022, OPKO acquired ModeX Therapeutics to expand its pipeline with multi-specific immune therapies for cancer and infectious diseases[20](index=20&type=chunk) - The company operates in two reportable segments: diagnostics (BioReference clinical labs) and pharmaceuticals (operations in Chile, Mexico, Ireland, Israel, Spain, U.S., and global R&D)[30](index=30&type=chunk) [Growth Strategy](index=7&type=section&id=GROWTH%20STRATEGY) - Continue to enhance commercialization capability in the U.S. and internationally[30](index=30&type=chunk) - Obtain regulatory approval and compile clinical data for advanced product candidates[30](index=30&type=chunk) - Continue marketing Rayaldee and potentially expand its label to additional indications[30](index=30&type=chunk) - Support Pfizer's efforts to secure U.S. regulatory approval for Somatrogon (hGH-CTP)[30](index=30&type=chunk) - Leverage the acquisition of ModeX to expand the pharmaceutical product line with its MSTAR platform for multispecific antibodies[27](index=27&type=chunk) - Expand BioReference's core laboratory services and seek new strategic ventures with large healthcare groups[31](index=31&type=chunk) [Current Products and Services](index=9&type=section&id=CURRENT%20PRODUCTS%20AND%20SERVICES%20AND%20RELATED%20MARKETS) - The company's business is divided into two main areas: Diagnostics and Pharmaceuticals[32](index=32&type=chunk)[48](index=48&type=chunk) - Diagnostics are primarily driven by BioReference, one of the largest full-service labs in the U.S., offering routine and esoteric testing, and the 4Kscore test for prostate cancer[32](index=32&type=chunk)[43](index=43&type=chunk) - The pharmaceutical portfolio includes the commercial product Rayaldee for kidney disease, and a pipeline of candidates including Somatrogon (hGH-CTP) for growth hormone deficiency, assets from the ModeX acquisition for oncology and infectious diseases, and other early-stage biologics and therapeutics[48](index=48&type=chunk)[60](index=60&type=chunk)[75](index=75&type=chunk) - The company also has international commercial operations in Europe and Latin America, and an API manufacturing subsidiary in Israel[88](index=88&type=chunk)[92](index=92&type=chunk) [Research and Development Expenses](index=17&type=section&id=RESEARCH%20AND%20DEVELOPMENT%20EXPENSES) R&D Expense | Year | R&D Expense (in millions) | | :--- | :--- | | 2022 | $73.9 | | 2021 | $76.9 | | 2020 | $75.3 | - Research and development expenses primarily consisted of development programs for **hGH-CTP and Rayaldee**[99](index=99&type=chunk) [Intellectual Property](index=17&type=section&id=INTELLECTUAL%20PROPERTY) - The company employs a comprehensive intellectual property strategy, seeking protection through U.S. and foreign patents, trademarks, trade secrets, and contractual arrangements[100](index=100&type=chunk)[101](index=101&type=chunk) - Rayaldee is protected by multiple U.S. patent families with expiration dates extending to **at least 2034**[103](index=103&type=chunk)[104](index=104&type=chunk) - Somatrogon (hGH-CTP) is covered by multiple U.S. patent families, with some expiring in **2027/2028** and others, if granted, extending to **2033**[105](index=105&type=chunk) - Patents for OPK88003 (oxyntomodulin) and OPK88004 (SARM) expire in **December 2030** and **November 2027**, respectively, without extensions[106](index=106&type=chunk) [Competition](index=19&type=section&id=COMPETITION) - The pharmaceutical and diagnostic testing industries are highly competitive, characterized by rapid technological advancements and a strong emphasis on proprietary products[110](index=110&type=chunk) - Competitors include major pharmaceutical companies, specialty pharma, biotech firms, and large reference laboratories like **Quest Diagnostics** and **Laboratory Corporation of America**, most of whom have substantially greater financial and operational resources[111](index=111&type=chunk)[114](index=114&type=chunk) - Rayaldee competes with activated vitamin D analogs and vitamin D supplements[112](index=112&type=chunk) - Long-acting hGH-CTP faces competition from several companies developing sustained-release growth hormone products and existing generic daily hGH products[113](index=113&type=chunk) [Government Regulation](index=20&type=section&id=GOVERNMENT%20REGULATION) - The company's operations are subject to extensive regulation by U.S. federal, state, and local authorities, including the FDA and CMS, as well as similar agencies in other countries[116](index=116&type=chunk)[117](index=117&type=chunk) - Clinical laboratory operations must comply with the **Clinical Laboratory Improvement Amendments (CLIA)**, which mandate specific standards for quality, personnel, and inspections[118](index=118&type=chunk)[119](index=119&type=chunk) - Drug development is a lengthy and costly process requiring preclinical studies and multi-phase clinical trials to establish safety and efficacy before FDA approval can be sought via a New Drug Application (NDA) or Biologics License Application (BLA)[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk) - The company is subject to healthcare fraud and abuse laws, including the **Anti-Kickback Statute**, the **Stark law**, and the **False Claims Act**, which carry significant civil and criminal penalties for violations[146](index=146&type=chunk)[148](index=148&type=chunk)[150](index=150&type=chunk) - Privacy and security of patient information are governed by **HIPAA** and other regulations like **GDPR** in Europe, with substantial penalties for non-compliance[143](index=143&type=chunk)[145](index=145&type=chunk) [Human Capital Resources](index=27&type=section&id=HUMAN%20CAPITAL%20RESOURCES) - As of December 31, 2022, the company had **4,196 full-time employees** worldwide[160](index=160&type=chunk) - The company focuses on employee health and safety, complying with OSHA, CLIA, and College of American Pathologists requirements[161](index=161&type=chunk) - OPKO is committed to competitive pay, benefits, diversity, inclusion, and talent development, and has adopted a Code of Business Conduct and Ethics for all employees[162](index=162&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks from operating losses, R&D outcomes, regulatory hurdles, competition, and reliance on key personnel and third parties [Risks Related to Our Business](index=28&type=section&id=RISKS%20RELATED%20TO%20OUR%20BUSINESS) - The company has a **history of operating losses** and may not achieve profitability, especially as COVID-19 testing revenue declines[169](index=169&type=chunk) - Additional funding may be required but may not be available on acceptable terms, if at all[171](index=171&type=chunk)[174](index=174&type=chunk) - The business is substantially dependent on the commercial success of its laboratory operations and key pharmaceutical products like Somatrogon (hGH-CTP), which has **not yet received FDA approval in the U.S.**[187](index=187&type=chunk)[195](index=195&type=chunk) - The company faces intense competition from larger, better-resourced companies in the pharmaceutical and diagnostics industries[200](index=200&type=chunk) - Success is highly dependent on the involvement and reputation of Chairman and CEO, **Phillip Frost, M.D.**[219](index=219&type=chunk) - Failure to obtain and enforce patent protection for products could materially harm the business[243](index=243&type=chunk) [Risks Related to Regulatory Compliance](index=45&type=section&id=RISKS%20RELATED%20to%20REGULATORY%20COMPLIANCE) - Failure to maintain **CLIA certification** and comply with its requirements could lead to the suspension or revocation of the laboratory's ability to conduct business[268](index=268&type=chunk) - The regulatory approval process for drugs and devices is expensive, time-consuming, and uncertain, and may prevent the commercialization of product candidates[270](index=270&type=chunk) - The company is subject to complex healthcare laws (e.g., **Anti-Kickback, Stark, False Claims Act**), and failure to comply could result in significant penalties and exclusion from federal healthcare programs[280](index=280&type=chunk) - Changes in healthcare reimbursement policies, particularly from Medicare and Medicaid, could adversely affect the profitability of diagnostic services[294](index=294&type=chunk)[298](index=298&type=chunk) - Failure to maintain the security of patient-related information under **HIPAA** and other privacy laws could damage reputation and result in substantial costs and litigation[282](index=282&type=chunk) [Risks Related to International Operations](index=51&type=section&id=RISKS%20RELATED%20TO%20INTERNATIONAL%20OPERATIONS) - Marketing products abroad requires separate regulatory approvals in each jurisdiction, which is a complex and uncertain process[304](index=304&type=chunk) - Foreign governments often impose strict price controls, which may adversely affect future profitability[305](index=305&type=chunk) - Operations in Israel expose the company to potential political, economic, and military instability in the region[306](index=306&type=chunk) - A significant portion of revenue comes from international sales, subjecting the company to risks from currency exchange rate fluctuations[307](index=307&type=chunk) - The company is subject to the **U.S. Foreign Corrupt Practices Act (FCPA)**, and violations could lead to severe penalties[310](index=310&type=chunk) [Risks Related to Acquisitions and Investments](index=52&type=section&id=RISKS%20RELATED%20TO%20ACQUISITIONS%20AND%20INVESTMENTS) - The company has a large amount of goodwill and other intangible assets (**$1.6 billion at Dec 31, 2022**) that are subject to periodic impairment evaluations, which could result in significant non-cash charges[317](index=317&type=chunk) - Underperformance of assets like Rayaldee or failure to gain U.S. approval for Somatrogon could trigger a **material impairment charge**[318](index=318&type=chunk)[319](index=319&type=chunk) [Risks Related to Ownership of Our Common Stock](index=53&type=section&id=RISKS%20RELATED%20TO%20OWNERSHIP%20OF%20OUR%20COMMON%20STOCK) - The trading price of the company's common stock may fluctuate significantly due to various factors, including clinical trial results, regulatory developments, and market conditions[320](index=320&type=chunk) - As of February 15, 2023, directors, executive officers, and affiliates beneficially owned approximately **47.4% of voting securities**, with Chairman and CEO Dr. Phillip Frost owning about **31.6%**, concentrating significant control[321](index=321&type=chunk) - A historically significant short position in the stock (**4.7% as of Jan 31, 2023**) could create downward pressure and volatility in the stock price[323](index=323&type=chunk) - Failure to maintain effective internal controls could lead to a loss of investor confidence and a decline in stock price[325](index=325&type=chunk) [Properties](index=55&type=section&id=Item%202.%20Properties) The company leases its corporate office in Miami and owns key manufacturing facilities in Mexico and Spain, with other significant properties leased globally Key Property Overview | Location | Purpose | Occupancy | | :--- | :--- | :--- | | Miami, FL | Corporate Headquarters | Leased | | Elmwood Park, NJ | Main Laboratory | Leased | | Guadalajara, Mexico | Pharmaceutical Manufacturing | Owned | | Banyoles, Spain | Pharmaceutical Manufacturing | Owned | | Waterford, Ireland | Pharmaceutical Manufacturing | Leased | | Nesher, Israel | API Manufacturing | Leased | [Legal Proceedings](index=55&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in significant legal matters, including a potential Texas Medicaid fraud violation and a ~$246 million Israeli tax assessment - In February 2023, the Texas Attorney General's Office alleged that BioReference may have violated the **Texas Medicaid Fraud Prevention Act** from 2005 to the present[333](index=333&type=chunk) - On December 29, 2022, the Israel Tax Authority issued a tax assessment of approximately **$246 million** (including interest) against OPKO Biologics for tax years 2014-2020, which the company is appealing[334](index=334&type=chunk) - The company is responding to a Civil Investigative Demand (CID) from the U.S. Department of Justice regarding potential violations of the **False Claims Act** and **Anti-Kickback Statute**, in which the government has declined to intervene but a private relator's complaint has been served[337](index=337&type=chunk) [Part II](index=57&type=section&id=Part%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=57&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) OPKO's stock (OPK) trades on NASDAQ and Tel Aviv, has not paid dividends, and has underperformed the S&P 500 and NASDAQ Biotechnology Index - The company's common stock is traded on the NASDAQ Stock Market and the Tel Aviv Stock Exchange under the symbol **"OPK"**[342](index=342&type=chunk) - As of February 15, 2023, there were approximately **374 holders of record** of the Common Stock[343](index=343&type=chunk) - The company has not declared or paid any cash dividends on its Common Stock and does not anticipate doing so in fiscal 2023[343](index=343&type=chunk) Five-Year Stock Performance Comparison | Index | 12/31/2017 | 12/31/2022 | | :--- | :--- | :--- | | OPKO Health, Inc. | $100.00 | $25.50 | | S&P 500 | $100.00 | $156.80 | | NASDAQ Biotechnology | $100.00 | $129.50 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=59&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) A 43% revenue decline in 2022 to $1.0 billion, driven by lower COVID-19 testing, resulted in a $226.3 million operating loss [Results of Operations](index=60&type=section&id=RESULTS%20OF%20OPERATIONS) - The COVID-19 pandemic significantly impacted results, with high testing volumes boosting revenue in 2020 and 2021, followed by a **sharp decline in 2022** as demand waned[353](index=353&type=chunk)[354](index=354&type=chunk) Financial Performance Summary | (In thousands) | 2022 | 2021 | % Change | | :--- | :--- | :--- | :--- | | Total revenues | $1,004,196 | $1,774,718 | (43)% | | Total costs and expenses | $1,230,449 | $1,755,968 | (30)% | | Income (loss) from operations | $(226,253) | $18,750 | (1307)% | - Diagnostics segment revenue decreased by **53% in 2022 to $755.6 million**, primarily due to lower demand and reimbursement for COVID-19 testing[360](index=360&type=chunk) - Pharmaceuticals segment revenue increased by **48% in 2022 to $248.6 million**, largely driven by **$85.0 million** in regulatory milestone payments from Pfizer for NGENLA® (Somatrogon)[371](index=371&type=chunk) - Net loss for 2022 was **$328.4 million**, compared to a net loss of $30.1 million in 2021, influenced by lower operating income and a **$150.9 million expense** from the decrease in fair value of the company's investment in GeneDx Holdings[383](index=383&type=chunk)[517](index=517&type=chunk) [Liquidity and Capital Resources](index=70&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) - As of December 31, 2022, the company had cash and cash equivalents of **$153.2 million**[414](index=414&type=chunk) - Key cash inflows in 2022 included **$115.4 million** net proceeds from the sale of GeneDx and **$85.0 million** in milestone payments from Pfizer for NGENLA®[414](index=414&type=chunk)[418](index=418&type=chunk) - The company has several convertible notes outstanding, including **$142.1 million of 4.50% notes due 2025** and **$55.0 million of 5% notes due 2023** (subsequently extended to 2025)[419](index=419&type=chunk)[422](index=422&type=chunk)[423](index=423&type=chunk) - As of December 31, 2022, the company had total credit line commitments of $63.2 million, with $31.8 million drawn; BioReference's secured revolving credit facility had **$16.8 million available** for borrowing[424](index=424&type=chunk)[425](index=425&type=chunk) - Management believes that cash on hand and available credit are sufficient to meet cash requirements for operations and debt service **beyond the next 12 months**[429](index=429&type=chunk) [Critical Accounting Policies and Estimates](index=73&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20ESTIMATES) - **Goodwill and Intangible Assets**: Goodwill and indefinite-lived intangible assets are tested for impairment annually or when triggering events occur; this process requires significant judgment in estimating fair value, and impairment charges may occur if future results do not meet estimates, particularly for the diagnostics segment and the Somatrogon IPR&D asset[436](index=436&type=chunk)[442](index=442&type=chunk) - **Revenue Recognition**: Revenue from laboratory services is recognized when test results are reported, net of variable consideration such as contractual allowances and implicit price concessions; revenue from product sales (e.g., Rayaldee) is recognized upon delivery, net of estimated rebates, chargebacks, and returns; revenue from intellectual property involves complex judgments on performance obligations, transaction price, and timing of recognition for upfront fees, milestones, and royalties[446](index=446&type=chunk)[456](index=456&type=chunk)[460](index=460&type=chunk) - **Contingent Consideration**: Obligations from prior acquisitions are revalued to fair value each period, with changes recorded in earnings; this requires significant judgment regarding the probability and timing of milestone achievements and the discount rates used[477](index=477&type=chunk)[478](index=478&type=chunk) - **Income Taxes**: Deferred tax assets and liabilities are recognized for future tax consequences; a valuation allowance is established against deferred tax assets if it is more-likely-than-not that they will not be realized[474](index=474&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=79&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exposed to market risks from foreign currency exchange rates, primarily the Chilean Peso and Euro, and interest rate changes - The company is exposed to foreign currency exchange rate risk, primarily from the **Chilean Peso and the Euro**, as **21.6% of 2022 revenue** was denominated in non-USD currencies[481](index=481&type=chunk)[484](index=484&type=chunk) - To manage currency risk, the company uses foreign exchange forward contracts to hedge forecasted cash flows, particularly for inventory purchases[482](index=482&type=chunk) - Interest rate risk affects cash and investments, as well as variable-rate borrowings; the investment portfolio consists of short-term, low-risk instruments to minimize this risk[486](index=486&type=chunk) - As of December 31, 2022, the company had **$31.8 million in variable-rate debt** with a weighted average interest rate of approximately **5.5%**; the upcoming phase-out of LIBOR presents uncertainty for this debt[487](index=487&type=chunk)[488](index=488&type=chunk) [Financial Statements and Supplementary Data](index=81&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for FY2022, including the independent auditor's report from Ernst & Young LLP [Report of Independent Registered Public Accounting Firm](index=82&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) - Ernst & Young LLP issued an **unqualified opinion** on OPKO Health's consolidated financial statements for the year ended December 31, 2022, stating they are presented fairly in conformity with U.S. GAAP[495](index=495&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, 2022[496](index=496&type=chunk)[505](index=505&type=chunk) - A **Critical Audit Matter** was identified concerning the estimation of variable consideration in determining revenue from services, due to the complexity and judgment required in evaluating factors like reimbursement regulations and collection experience[502](index=502&type=chunk) [Consolidated Financial Statements](index=85&type=section&id=Consolidated%20Financial%20Statements) Consolidated Balance Sheet Highlights (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Total Assets** | **$2,167,259** | **$2,399,715** | | Cash and cash equivalents | $153,191 | $134,710 | | Goodwill & Intangibles | $1,614,371 | $1,432,484 | | **Total Liabilities** | **$605,611** | **$714,589** | | Convertible notes | $213,421 | $187,935 | | **Total Shareholders' Equity** | **$1,561,648** | **$1,685,126** | Consolidated Statement of Operations Highlights (in thousands) | | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | Total revenues | $1,004,196 | $1,774,718 | $1,435,413 | | Operating income (loss) | $(226,253) | $18,750 | $57,714 | | Net income (loss) | $(328,405) | $(30,143) | $30,586 | | EPS (basic and diluted) | $(0.46) | $(0.05) | $0.05 | Consolidated Statement of Cash Flows Highlights (in thousands) | | 2022 | 2021 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(95,189) | $38,337 | | Net cash provided by investing activities | $91,038 | $35,949 | | Net cash provided by (used in) financing activities | $22,971 | $(10,350) | | Net increase in cash | $18,481 | $62,499 | [Notes to Consolidated Financial Statements](index=91&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) - In May 2022, OPKO acquired ModeX Therapeutics for a purchase price of **$300 million**, paid entirely in OPKO common stock; the acquisition added **$195 million in IPR&D assets** and **$80.4 million in goodwill**[532](index=532&type=chunk)[593](index=593&type=chunk) - In April 2022, OPKO completed the sale of its subsidiary GeneDx to Sema4 (now GeneDx Holdings) for **$150 million in cash** and **80 million shares** of GeneDx Holdings stock, recognizing a gain of **$18.6 million**[534](index=534&type=chunk)[535](index=535&type=chunk)[537](index=537&type=chunk) - The company adopted ASU 2020-06 on January 1, 2022, which simplified the accounting for convertible instruments; this resulted in an increase to the carrying value of the 2025 Convertible notes by **$21.6 million** and adjustments to retained earnings and additional paid-in capital[583](index=583&type=chunk)[584](index=584&type=chunk) - As of Dec 31, 2022, the company had federal, state, and foreign net operating loss carryforwards of approximately **$423.8 million**, **$774.5 million**, and **$83.8 million**, respectively; a valuation allowance is maintained against deferred tax assets not expected to be realized[663](index=663&type=chunk) - In July 2022, the company and BioReference entered into a settlement agreement with the U.S. Department of Justice and other parties, agreeing to pay approximately **$10 million** to resolve allegations related to certain overpayments for office space rentals that occurred prior to OPKO's acquisition of BioReference[696](index=696&type=chunk)[697](index=697&type=chunk) [Controls and Procedures](index=135&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management and the independent auditor concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2022[787](index=787&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2022[789](index=789&type=chunk) - The independent registered public accounting firm, Ernst & Young LLP, audited and provided an **unqualified opinion** on the effectiveness of the company's internal control over financial reporting as of December 31, 2022[790](index=790&type=chunk) - No changes to the company's internal control over financial reporting occurred during the fourth quarter of 2022 that materially affected, or are reasonably likely to materially affect, these controls[791](index=791&type=chunk) [Part III](index=136&type=section&id=Part%20III) [Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, and Principal Accounting Fees](index=136&type=section&id=Items%2010-14) Required information for Items 10-14 is incorporated by reference from the company's 2023 definitive proxy statement - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the registrant's definitive proxy statement for its 2023 Annual Meeting of Stockholders[8](index=8&type=chunk)[796](index=796&type=chunk) [Part IV](index=137&type=section&id=Part%20IV) [Exhibits, Financial Statement Schedules](index=137&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the Form 10-K, including material contracts, debt indentures, and executive certifications - This section contains the index to financial statements, financial statement schedules, and a comprehensive list of exhibits filed with the report[799](index=799&type=chunk)[800](index=800&type=chunk) - Key exhibits listed include the Agreement and Plan of Merger with ModeX Therapeutics, Inc., the Amended and Restated Development and Commercialization License Agreement with Pfizer, and various debt-related indentures and credit agreements[801](index=801&type=chunk)[802](index=802&type=chunk)[803](index=803&type=chunk) - Certifications by the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are included as exhibits[804](index=804&type=chunk)

OPKO Health, Inc. (NASDAQ:OPK) Q4 2022 Earnings Conference Call February 23, 2023 4:30 PM ET Company Participants Yvonne Briggs - LHA Investor Relations Phillip Frost - Chairman & CEO Elias Zerhouni - President & Vice Chairman Steven Rubin - EVP, Administration & Director Gary Nabel - Chief Innovation Officer & Director Adam Logal - SVP, CFO, CAO & Treasurer Conference Call Participants Kevin Strang - Jefferies Jeffrey Cohen - Ladenburg Thalmann Edward Tenthoff - Piper Sandler Yale Jen - Laidlaw & Company Y ...

OPKO Health, Inc. (NASDAQ:OPK) Q3 2022 Earnings Conference Call November 8, 2022 4:30 PM ET Company Participants Yvonne Briggs - LHA Investor Relations Phillip Frost - Chairman and Chief Executive Officer Adam Logal - SVP and Chief Financial Officer Jon Cohen - SVP and Executive Chairman Elias Zerhouni - President and Vice Chairman Conference Call Participants Kevin Strang - Jefferies Jeffrey S. Cohen - Ladenburg Thalmann Company Inc. Edward Tenthoff - Piper Sandler Operator Good day and welcome to the OPKO ...