OPKO HEALTH, INC.

Previous wording

ITEM 2. MANAGEMENT**’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Current wording

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Previous wording

We are a diversified healthcare company that seeks to establish industry leading positions in large and rapidly growing medical markets. Our pharmaceutical business features Somatrogon (hGH-CTP), a once-weekly human growth hormone injection. We have partnered with Pfizer Inc. (“Pfizer”) for the development and commercialization of Somatrogon (hGH-CTP). Regulatory approvals for Somatrogon (hGH-CTP) for the treatment of growth hormone deficiency in children and adolescents have been secured in more than 50 markets, including the United States, European Union ("EU") Member States, Japan, Canada, and Australia, where it is marketed under the brand name NGENLA®. We also manufacture and sellRayaldee, an FDA approved treatment for secondary hyperparathyroidism ("SHPT") in adults with stage 3 or 4 chronic kidney disease ("CKD") and vitamin D insufficiency, through our pharmaceutical division. We have also expanded our pharmaceutical pipeline with early-stage immune therapies targeting cancer and infectious diseases through our 2022 acquisition of ModeX Therapeutics, Inc. ("ModeX").

Current wording

We are a diversified healthcare company that seeks to establish industry leading positions in large and rapidly growing medical markets. Our pharmaceutical business features Somatrogon (hGH-CTP), a once-weekly human growth hormone injection. We have partnered with Pfizer Inc. (“Pfizer”) for the development and commercialization of Somatrogon (hGH-CTP). Regulatory approvals for Somatrogon (hGH-CTP) for the treatment of growth hormone deficiency in children and adolescents have been secured in more than 50 markets, including the United States, European Union ("EU") Member States, Japan, Canada, and Australia, where it is marketed under the brand name NGENLA®. We also manufacture and sell Rayaldee, an FDA approved treatment for secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) and vitamin D insufficiency, through our pharmaceutical division. We have also expanded our pharmaceutical pipeline with early-stage immune therapies targeting cancer and infectious diseases through our 2022 acquisition of ModeX Therapeutics, Inc. (“ModeX”).

Previous wording

In April 2025, the U.S. government announced a baseline tariff of 10% on products imported from all countries and an additional individualized reciprocal tariff on the countries with which the United States has the largest trade deficits, including China. Increased tariffs by the United States have led and may continue to lead to the imposition of retaliatory tariffs by foreign jurisdictions. Additionally, the U.S. government has announced and rescinded multiple tariffs on several foreign jurisdictions, which has increased uncertainty regarding the ultimate effect of the tariffs on economic conditions. Current uncertainties about tariffs and their effects on trading relationships may affect costs for and availability of raw materials or contribute to inflation in the markets in which we operate. Although we are continuing to monitor the economic effects of such announcements, as well as opportunities to mitigate their related impacts, costs and other effects associated with the tariffs remain uncertain.

Current wording

In April 2025, the U.S. government announced a series of tariffs on products imported from all countries and an additional individualized reciprocal tariff on the countries with which the United States has the largest trade deficits, including China. Certain of these tariffs have been stayed or otherwise modified, and, since April 2025, the U.S. government has continued to announce new or revised tariffs. Increased tariffs by the United States have led and may continue to lead to the imposition of retaliatory tariffs by foreign jurisdictions. Additionally, the U.S. government has announced and rescinded multiple tariffs on several foreign jurisdictions, which has increased uncertainty regarding the ultimate effect of the tariffs on economic conditions. Current uncertainties about tariffs and their effects on trading relationships may affect costs for and availability of raw materials or contribute to inflation in the markets in which we operate. Although we are continuing to monitor the economic effects of such announcements, as well as opportunities to mitigate their related impacts, costs and other effects associated with the tariffs remain uncertain.

Previous wording

On April 4, 2025, the Company announced that its Board of Directors had authorized an increase of $100.0 million to the Company's existing Common Stock repurchase program, originally established on July 18, 2024, bringing the aggregate capacity of the program to $200.0 million. As previously reported in our Annual Report on Form 10-K for the year ended December 31, 2024, the Company had repurchased 25,825,785 shares at an average price per share of $1.56, for a total cost of approximately $40.2 million under this program through that date. No shares were repurchased during the three months ended March 31, 2025.

Current wording

On April 4, 2025, the Company announced that its Board of Directors authorized an increase of $100.0 million to the Company's existing Common Stock repurchase program, originally established on July 18, 2024, bringing its aggregate capacity to $200.0 million. As previously reported in the Form 10-K for the year ended December 31, 2024, the Company had repurchased 25,825,785 shares at an average price per share of $1.56, for a cost of approximately $40.2 million. An additional 13,646,344 shares were repurchased at an average price per share of $1.33, for a cost of approximately $18.3 million during the six months ended June 30, 2025. As of June 30, 2025, the total cost of repurchases under the program was approximately $58.5 million.

Previous wording

Approximately 22.3% of our revenue for the three months ended March 31, 2025, was denominated in currencies other than the U.S. Dollar (USD). This compares to 21.5% for the same period in 2024. Our financial statements are reported in USD; therefore, fluctuations in exchange rates affect the translation of foreign-denominated revenue and expenses. During the three months ended March 31, 2025 and the year ended December 31, 2024, our most significant currency exchange rate exposures were to the Chilean Peso and Euro. Gross accumulated currency translation adjustments, recorded as a separate component of shareholders’ equity, totaled $41.6 million and $52.7 million at March 31, 2025 and December 31, 2024, respectively.

Current wording

Approximately 24.5% of our revenue for the six months ended June 30, 2025, was denominated in currencies other than the U.S. Dollar (USD). This compares to 21.7% for the same period in 2024. Our financial statements are reported in USD; therefore, fluctuations in exchange rates affect the translation of foreign-denominated revenue and expenses. During the six months ended June 30, 2025 and the year ended December 31, 2024, our most significant currency exchange rate exposures were to the Chilean Peso and Euro. Gross accumulated currency translation adjustments, recorded as a separate component of shareholders’ equity, totaled $21.3 million and $52.7 million at June 30, 2025 and December 31, 2024, respectively.

Previous wording

We are subject to foreign currency transaction risk due to fluctuations in exchange rates between the time a transaction is initiated and settled. To mitigate this risk, we use foreign currency forward contracts. These contracts fix an exchange rate, allowing us to offset potential losses (or gains) caused by exchange rate changes at the settlement date. As of March 31, 2025 and December 31, 2024, we held 60 and zero open foreign exchange forward contracts, respectively, related to inventory purchases on letters of credit.

Current wording

We are subject to foreign currency transaction risk due to fluctuations in exchange rates between the time a transaction is initiated and settled. To mitigate this risk, we use foreign currency forward contracts. These contracts fix an exchange rate, allowing us to offset potential losses (or gains) caused by exchange rate changes at the settlement date. As of June 30, 2025, we held $12.0 million in open foreign exchange forward contracts related to inventory purchases on letters of credit, compared to zero open contracts as of December 31, 2024.

Previous wording

Our consolidated (loss) income from operations for the three months ended March 31, 2025 and 2024 was as follows:

Current wording

Our consolidated (loss) from operations for the three months ended June 30, 2025 and 2024 was as follows:

Previous wording

Revenue. Revenue from services for the three months ended March 31, 2025 decreased by approximately $24.1 million, a decrease of 19.0% compared to the same period in 2024. The decrease resulted from revenue reductions totaling $35.4 million (composed of $26.9 million due to the absence of revenue following the sale of certain of BioReference's lab operations to Labcorp in September 2024 (the "BioReference Transaction") and $8.5 million from lower clinical test volume in continuing operations). These decreases were partially offset by a $11.4 million increase attributed to higher clinical test reimbursement rates.

Current wording

Revenue. Revenue from services for the three months ended June 30, 2025 decreased by approximately$28.3 million, a decrease of 21.9% compared to the same period in 2024. The decrease resulted from revenue reductions totaling $35.6 million, composed of $25.5 million due to the absence of revenue following the sale of certain of BioReference's lab operations to Labcorp in September 2024 (the “BioReference Transaction”) and $10.1 million from lower clinical test volume in continuing operations. These decreases were partially offset by a $7.3 million increase attributed to higher clinical test reimbursement rates.

Previous wording

Cost of revenue. Cost of revenue for the three months ended March 31, 2025 decreased $25.4 million, a decrease of 23.1% compared to the three months ended March 31, 2024. The decrease related to the previously mentioned divestiture of certain lab operations from the BioReference Transaction. These divested operations had incurred $24.5 million in cost of revenue for the three months ended March 31, 2024, costs which did not recur for the comparable 2025 period. The remaining decrease primarily reflects lower employee headcount, resulting from both the divestiture and ongoing cost-reduction initiatives at BioReference, as well as changes in the testing mix for the ongoing operations.

Current wording

Cost of revenue. Cost of revenue for the three months ended June 30, 2025 decreased$24.7 million, a decrease of 23.1% compared to the three months ended June 30, 2024. The decrease related predominantly to our disposition of certain lab operations in the BioReference Transaction. These divested operations had incurred $23.4 million in cost of revenue for the three months ended June 30, 2024, costs which did not recur for the comparable 2025 period. The remaining decrease primarily reflects lower employee headcount, resulting from both the divestiture and ongoing cost-reduction initiatives at BioReference, as well as changes in the testing mix for the ongoing operations.

Previous wording

Amortization of intangible assets. Amortization of intangible assets was $3.8 million and $5.0 million, respectively, for the three months ended March 31, 2025 and 2024. This decrease is primarily due to the removal of amortizable intangible assets associated with the lab operations divested in September 2024.

Current wording

Amortization of intangible assets. Amortization of intangible assets was$3.0 million and$4.0 million, respectively, for the three months ended June 30, 2025 and 2024. This decrease was primarily due to the removal of amortizable intangible assets associated with the lab operations divested in September 2024 and held for sale assets included in the Oncology Transaction.

Previous wording

*Revenue from transfer of intellectual property and other.*For the three months ended March 31, 2025, revenue from the transfer of intellectual property and other was $12.3 million compared to $8.7 million for the prior year period, an increase of $3.5 million. This increase was primarily attributable to $7.0 million recognized under the BARDA Contract (as defined and described in Note 14 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q) compared to $2.2 million in the 2024 period. This positive contribution was partially offset by a decrease in gross profit share and royalty payments for NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), which totaled $4.5 million compared with $5.6 million for the same period in 2024.

Current wording

Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $2.7 million to $15.0 million for the three months ended June 30, 2025, from $12.3 million in the same period last year. This growth was primarily driven by a $1.5 million increase from the BARDA Contract (as defined and described in Note 14 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q), with revenue of $6.5 million for the three months ended June 30, 2025 compared to $5.0 million in the 2024 period. Additionally, contract manufacturers' commercial milestones contributed a $2.0 million increase, rising to $2.3 million from $0.3 million in the prior year. These gains were partially offset by a $0.2 million reduction in gross profit share and royalty payments from NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), which totaled $6.1 million for the three months ended June 30, 2025 compared to $6.3 million in 2024.

Previous wording

Research and development expenses. Research and development expenses for the three months ended March 31, 2025 and 2024 were $30.2 million and $21.3 million, respectively, an increase of 42.3% from the prior year period. Research and development expenses include external and internal expenses, partially offset by third-party grants and funding arising from collaboration agreements. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, purchases of drug and diagnostic product materials and manufacturing development costs. We track external research and development expenses by individual program for phase 3 clinical trials for drug approval and premarket approval for diagnostics tests, if any. Internal expenses include employee-related expenses such as salaries, benefits and equity-based compensation expense. Other internal research and development expenses are incurred to support overall research and development activities and include expenses related to general overhead and facilities.

Current wording

Research and development expenses. Research and development expenses for the three months ended June 30, 2025 and 2024 were$29.8 million and$23.7 million, respectively, an increase of 25.7% from the prior year period. Research and development expenses include external and internal expenses, partially offset by third-party grants and funding arising from collaboration agreements. External expenses include clinical and non-clinical activities performed by contract research organizations, lab services, purchases of drug and diagnostic product materials and manufacturing development costs. We track external research and development expenses by individual program for phase 3 clinical trials for drug approval and premarket approval for diagnostics tests, if any. Internal expenses include employee-related expenses such as salaries, benefits and equity-based compensation expense. Other internal research and development expenses are incurred to support overall research and development activities and include expenses related to general overhead and facilities.

Previous wording

Interest income. Interest income for the three months ended March 31, 2025 and 2024 was $4.7 million and $0.8 million, respectively. The increase in interest income is driven by interest earned on our larger cash investment.

Current wording

Interest income. Interest income for the three months ended June 30, 2025 and 2024 was$3.3 million and$0.4 million, respectively. The increase in interest income is driven by interest earned on our larger cash investment.

Previous wording

Income tax benefit. Our income tax benefit for the three months ended March 31, 2025 and 2024 was $5.8 million and $1.4 million, respectively. For the three months ended March 31, 2025 and 2024, the tax rate differed from the U.S. federal statutory rate of 21% primarily due to the relative mix in earnings and losses in the U.S. versus foreign tax jurisdictions, and operating results in tax jurisdictions which do not result in a tax benefit.

Current wording

Income tax benefit. Our income tax benefit for the three months ended June 30, 2025 and 2024 was$14.1 million and$0.3 million, respectively. For the three months ended June 30, 2025 and 2024, the tax rate differed from the U.S. federal statutory rate of 21% primarily due to the relative mix in earnings and losses in the U.S. versus foreign tax jurisdictions, and operating results in tax jurisdictions which do not result in a tax benefit.

Previous wording

Loss from investments in investees. We have invested in certain early-stage companies that we perceive to have valuable proprietary technology and significant potential to create value for us as an equity holder. We account for these investments under the equity method of accounting, resulting in the recording of our proportionate share of their losses until our share of their loss exceeds our investment. Until the investees’ technologies are commercialized, if ever, we anticipate they will report net losses Loss from investments in investees was $8.7 thousand and $2.7 thousand for the three months ended March 31, 2025 and 2024, respectively.

Current wording

Loss from investments in investees. We have invested in certain early-stage companies that we perceive to have valuable proprietary technology and significant potential to create value for us as an equity holder. We account for these investments under the equity method of accounting, resulting in the recording of our proportionate share of their losses until our share of their loss exceeds our investment. Until the investees’ technologies are commercialized, if ever, we anticipate they will report net losses Loss from investments in investees was $0.0 thousand and $1.0 thousand for the three months ended June 30, 2025 and 2024, respectively.

Previous wording

Estimated collection amounts are subject to the complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, and require us to consider the potential for retroactive adjustments when estimating variable consideration in the recognition of revenue for the period during which the related services are rendered. For the three months ended March 31, 2025, we recorded $1.5 million of negative revenue adjustments due to changes in estimated implicit price concessions for services provided in prior periods, primarily due to shifts in the composition of our client mix. For the three months ended March 31, 2024, we recorded $0.5 million of positive revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods mainly due to the composition of client pay mix.

Current wording

Estimated collection amounts are subject to the complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, and require us to consider the potential for retroactive adjustments when estimating variable consideration in the recognition of revenue for the period during which the related services are rendered. For the six months ended June 30, 2025, we recorded $0.7 million of negative revenue adjustments due to changes in estimated implicit price concessions for services provided in prior periods, primarily due to shifts in the composition of our client mix. For the six months ended June 30, 2024, we recorded $0.9 million of negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods mainly due to the composition of patient pay mix.

Previous wording

Selling, general and administrative expenses. Selling, general and administrative expenses for the three months ended March 31, 2025 and 2024 were $38.0 million and $45.8 million, respectively, representing a decrease of 17.1% from the prior period. The decrease was primarily driven by the absence of $10.0 million in costs associated with divested operations (which had been incurred for the three months ended March 31, 2024), and lower employee-related expenses resulting from continued cost-reduction initiatives. These favorable impacts, which reduced ongoing expenses, were partially offset by $4.7 million in one-time costs recorded for the three months ended March 31, 2025 related to adjustments to the useful life of certain operating leases.

Current wording

Selling, general and administrative expenses. Selling, general and administrative expenses for the six months ended June 30, 2025 and 2024 were $71.3 million and $90.3 million, respectively, representing a decrease of 21.0% from the prior period. The decrease was primarily driven by the absence of $19.1 million in costs associated with divested operations (which had been incurred for the six months ended June 30, 2024), and lower employee-related expenses resulting from continued cost-reduction initiatives. These favorable impacts, which reduced ongoing expenses, were partially offset by $4.7 million in one-time costs recorded for the six months ended June 30, 2025 related to adjustments to the useful life of certain operating leases.

Previous wording

The decrease in research and development expenses for the three months ended March 31, 2025 as compared to 2024 was primarily due to a decrease in employee-related expenses as a result of the continued cost-reduction initiatives implemented at BioReference.

Current wording

The decrease in research and development expenses for the six months ended June 30, 2025 as compared to 2024 was primarily due to a decrease in employee-related expenses as a result of the continued cost-reduction initiatives implemented at BioReference.

Previous wording

Revenue from products. Revenue from products for the three months ended March 31, 2025 decreased $3.2 million or 8.4%, compared to the three months ended March 31, 2024. The decrease was primarily driven by unfavorable foreign exchange fluctuations impacting our international operations by approximately $1.9 million, a $0.6 million reduction inRayaldee sales, and unfavorable impacts from the timing of customer orders and product mix. While we experienced higher sales volumes for certain other products compared to 2024, the positive impact of this volume increase was more than offset by these combined negative factors, leading to the overall decrease.

Current wording

Revenue from products. Revenue from products for the six months ended June 30, 2025 decreased $2.9 million or 3.8%, compared to the six months ended June 30, 2024. The decrease was primarily driven by unfavorable foreign exchange fluctuations impacting our international operations by approximately $1.9 million, a $0.6 million reduction in Rayaldee sales, and unfavorable impacts from the timing of customer orders and product mix.

Previous wording

Cost of revenue. Cost of revenue for the three months ended March 31, 2025 increased $1.1 million, an increase of 4.9%, compared to the three months ended March 31, 2024. Cost of revenue increased primarily due to an unfavorable shift in product mix. This increase was partially offset by favorable foreign currency exchange rates, which reduced costs by $0.6 million compared to the prior year period.

Current wording

Cost of revenue. Cost of revenue for the six months ended June 30, 2025 increased $2.6 million, an increase of 5.8%, compared to the six months ended June 30, 2024. This increase was primarily driven by an unfavorable shift in product mix from our international subsidiaries and higher inventory costs from our Chilean subsidiary, which resulted from higher prices from foreign suppliers. This was partially offset by favorable foreign currency exchange rates, which reduced costs by $0.4 million compared to the prior year period.

Previous wording

Selling, general and administrative expenses. Selling, general and administrative expenses (SG&A) for the three months ended March 31, 2025 and 2024 were $12.7 million and $15.0 million, respectively, a decrease of 15.5% from the prior year period. The decrease was primarily driven by lower employee-related expenses, mainly associated withRayaldee commercial operations and also from our international operations. Additionally, SG&A benefited from a $0.4 million favorable impact from foreign currency exchange fluctuations and a $0.1 million decrease in equity-based compensation expense compared to the prior year period.

Current wording

Selling, general and administrative expenses. Selling, general and administrative expenses (SG&A) for the six months ended June 30, 2025 and 2024 were $25.9 million and $29.1 million, respectively, a decrease of 11.0% from the prior year period. This decrease was primarily driven by lower employee-related expenses, including $2.4 million associated with Rayaldee commercial operations and reductions from our international operations. Additionally, SG&A benefited from a $0.2 million favorable impact of foreign currency exchange fluctuations.

Previous wording

Research and development expenses for the three months ended March 31, 2025 increased primarily due to higher expenses at ModeX. This increase was driven by a combination of factors, including growth in our BARDA collaboration, advancements and expansion in our early-stage programs, and higher employee-related expenses.

Current wording

Research and development expenses for the six months ended June 30, 2025 increased primarily due to higher expenses at ModeX. This increase was driven by a combination of factors, including growth in our BARDA collaboration and higher employee-related expenses due to an increase in headcount.

Previous wording

Amortization of intangible assets. Amortization of intangible assets was $16.1 million and $16.4 million, respectively, for the three months ended March 31, 2025 and 2024. Amortization expense reflects the amortization of acquired intangible assets with defined useful lives. Our indefinite lived IPR&D assets will not be amortized until the underlying development programs are completed. Upon obtaining regulatory approval by the FDA, the IPR&D assets will be accounted for as a finite-lived intangible asset and amortized on a straight-line basis over its estimated useful life. The assets will be amortized on a straight-line basis over their estimated useful life of approximately 12 years.

Current wording

Amortization of intangible assets. Amortization of intangible assets was $32.5 million and $32.9 million, respectively, for the six months ended June 30, 2025 and 2024. The expense reflects the amortization of acquired intangible assets with defined useful lives. Our indefinite lived IPR&D assets will not be amortized until the underlying development programs are completed. Upon obtaining regulatory approval by the FDA, the IPR&D assets will be accounted for as a finite-lived intangible asset and amortized on a straight-line basis over its estimated useful life. The assets will be amortized on a straight-line basis over their estimated useful life of approximately 12 years.

Previous wording

Operating loss for our unallocated corporate operations for the three months ended March 31, 2025 and 2024 was $8.5 million and $9.4 million, respectively, and principally reflects general and administrative expenses incurred in connection with our corporate operations. The decrease in operating loss for our unallocated corporate operations was primarily due to a decrease in professional fees expenses.

Current wording

Operating loss for our unallocated corporate operations for the six months ended June 30, 2025 and 2024 was $21.5 million and $19.7 million, respectively, and principally reflects general and administrative expenses incurred in connection with our corporate operations. The increase in operating loss was primarily due to higher employee-related expenses.

Previous wording

Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the three months ended March 31, 2025 and 2024, was $0.3 million and $26.2 million of expense, respectively. Derivative expense was principally related to the change in fair value on the 2029 Convertible Notes (see Note 7 for further information) and on foreign currency forward exchange contracts at OPKO Chile.

Current wording

Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the six months ended June 30, 2025 and 2024, was $0.3 million and $26.2 million of expense, respectively. Derivative expense was principally related to the change in fair value on the 2029 Convertible Notes (see Note 7 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for further information) and on foreign currency forward exchange contracts at OPKO Chile.

Previous wording

Other income, net. Other income, net decreased by $16.5 million to $4.9 million for the three months ended March 31, 2025, compared to $21.3 million in the prior year period. This decrease related primarily to our GeneDx (as defined in Note 6 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q) investment; we recognized $22.7 million of income from this investment in the first quarter of 2024 reflecting an increase in the fair value of our investment (primarily unrealized gains), compared to a $3.9 million realized gain upon selling our remaining shares in the first quarter of 2025. Partially offsetting this decrease was a $2.8 million favorable swing in foreign currency exchange effects, moving from a $2.7 million expense in the first quarter of 2024 to $0.1 million income in the first quarter of 2025.

Current wording

Other income (expense), net. Other income (expense), net decreased by $110.9 million to $30.7 million of expense for the six months ended June 30, 2025, compared to $80.2 million of income in the prior year period. The decrease is related primarily to our GeneDx (as defined in Note 6 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q) investment; we recognized $83.2 million of income in the second quarter of 2024 reflecting an increase in the fair value of our investment (primarily unrealized gains). Additionally, the six months ended June 30, 2025, included $32.6 million in inducement expense related to the Note Exchange Transactions (as defined in Note 6 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q). Furthermore, a foreign currency loss of $2.5 million was recorded for the 2025 period, compared with a $4.0 million loss in the 2024 period.

Previous wording

On March 31, 2025, we had cash, cash equivalents and restricted cash of approximately $449.7 million. Cash used in operations of $34.6 million for the three months ended March 31, 2025 principally reflects general and administrative expenses related to our corporate operations, research and development activities and sales and marketing activities related to our pharmaceutical and diagnostic business. Cash from investing activities was $40.5 million for the three months ended March 31, 2025 primarily reflected proceeds from the sale of equity securities, offset by an $8.0 million investment in Entera and capital expenditures. Cash provided by financing activities for the three months ended March 31, 2025 of $4.0 million primarily reflected net borrowings on our lines of credit. We have historically not generated sustained positive cash flow sufficient to offset our operating and other expenses, and our primary sources of cash have been from the public and private placement of equity and debt, as well as credit facilities available to us.

Current wording

On June 30, 2025, we had cash, cash equivalents and restricted cash of approximately$285.4 million. Cash used in operations of$118.0 million for the six months ended June 30, 2025 principally reflected general and administrative expenses related to our corporate operations, research and development activities and sales and marketing activities related to our pharmaceutical and diagnostic business. Cash from investing activities was$37.7 million for the six months ended June 30, 2025 primarily reflected proceeds from the sale of equity securities, offset by an $7.7 million investment in Entera and capital expenditures of $6.5 million. Cash used in financing activities for thesix months ended June 30, 2025 of$83.5 million primarily reflected net borrowings on our lines of credit. We have historically not generated sustained positive cash flow sufficient to offset our operating and other expenses, and our primary sources of cash have been from the public and private placement of equity and debt, as well as credit facilities available to us.

Previous wording

On April 4, 2024, the Company announced that its Board of Directors has authorized an increase of $100.0 million to the Company’s existing Common Stock repurchase program, bringing the aggregate capacity of the program to $200.0 million. Approximately $40.2 million of OPKO’s Common Stock has been repurchased under the existing program since its authorization in July 2024. Under this program, the Company may repurchase shares from time to time through various methods, including open market purchases, block trades, privately negotiated transactions, accelerated share repurchases, as well as pursuant to pre-set trading plans meeting the requirements of Rule 10b5-1(c) of the Exchange Act, and otherwise in compliance with applicable laws. The timing and amount of any repurchases will be subject to general market conditions, the Company's capital management, investment opportunities, and other factors. The repurchase program does not obligate the Company to repurchase any specific number of shares, has no time limit, and may be modified, suspended, or discontinued at any time at the Company's discretion.

Current wording

On April 4, 2025, the Company announced that its Board of Directors has authorized an increase of $100.0 million to the Company’s existing Common Stock repurchase program, bringing the aggregate capacity of the program to $200.0 million. Approximately $58.5 million shares of Common Stock has been repurchased under the existing program since its authorization in July 2024. Under this program, the Company may repurchase shares from time to time through various methods, including open market purchases, block trades, privately negotiated transactions, accelerated share repurchases, as well as pursuant to pre-set trading plans meeting the requirements of Rule 10b5-1(c) of the Exchange Act, and otherwise in compliance with applicable laws. The timing and amount of any repurchases is subject to general market conditions, the Company's capital management, investment opportunities, and other factors. The repurchase program does not obligate the Company to repurchase any specific number of shares, has no time limit, and may be modified, suspended, or discontinued at any time at the Company's discretion.

Previous wording

On April 1, 2025, the Company consummated exchange transactions related to its 2029 Convertible 144A Notes. Agreements were entered into with certain institutional holders on March 27 and March 28, 2025, and the exchange transactions closed on April 1, 2025. In total, the Company exchanged $159,221,000 aggregate principal amount of the 2029 Convertible 144A Notes for 121,437,998 shares of Common Stock and cash payments totaling approximately $63.5 million, inclusive of accrued and unpaid interest. The exchanged 2029 Convertible 144A Notes were subsequently retired.

Current wording

On April 1, 2025, the Company consummated the Note Exchange Transactions related to its 2029 Convertible 144A Notes. Agreements were entered into with certain institutional holders on March 27 and March 28, 2025, and the exchange transactions closed on April 1, 2025. In total, the Company exchanged $159,221,000 aggregate principal amount of the 2029 Convertible 144A Notes for 121,437,998 shares of Common Stock and cash payments totaling approximately $63.5 million, inclusive of accrued and unpaid interest. The exchanged 2029 Convertible 144A Notes were subsequently retired.

Previous wording

On March 10, 2025, the Company and BioReference entered into an agreement with Labcorp to acquire BioReference's oncology and related clinical testing services assets. The transaction is expected to close in the second half of 2025, with Labcorp paying up to $225 million in cash consideration, including $192.5 million in cash at closing and up to $32.5 million in cash in performance-based contingent consideration.

Current wording

On March 10, 2025, the Company and BioReference entered into an agreement with Labcorp, pursuant to which Labcorp has agreed to acquire BioReference's oncology and related clinical testing services assets. The transaction is expected to close in the second half of 2025, with Labcorp paying up to $225 million in cash consideration, including $192.5 million in cash at closing and up to $32.5 million in cash in performance-based contingent consideration.

Previous wording

On January 7th, 2025, ModeX announced the dosing of the first participant in a Phase 1 study of an EBV vaccine candidate being developed in collaboration with Merck. This achievement triggered a $12.5 million cash milestone payment from Merck to ModeX under the Merck Agreement. Related revenue of $12.5 million was recognized in the fourth quarter of 2024 upon satisfaction of the underlying performance obligation. Pursuant to the Merck Agreement, Merck obtained a license to certain patent rights and know-how in connection with the development of ModeX’s preclinical nanoparticle vaccine candidate targeting the Epstein-Barr Virus. 1 Under the terms of the Merck Agreement, ModeX is eligible to receive up to an additional $860.0 million upon the achievement of certain commercial and development milestones.

Current wording

On January 7, 2025, ModeX announced the dosing of the first participant in a Phase 1 study of an EBV vaccine candidate being developed in collaboration with Merck. This achievement triggered a $12.5 million cash milestone payment from Merck to ModeX under the Merck Agreement. Related revenue of $12.5 million was recognized in the fourth quarter of 2024 upon satisfaction of the underlying performance obligation. Pursuant to the Merck Agreement, Merck obtained a license to certain patent rights and know-how in connection with the development of ModeX’s preclinical nanoparticle vaccine candidate targeting the Epstein-Barr Virus. 1 Under the terms of the Merck Agreement, ModeX is eligible to receive up to an additional $860.0 million upon the achievement of certain commercial and development milestones.

Previous wording

ModeX and Merck have established a strategic collaboration with a detailed research plan to guide the development of such a vaccine or related product. This plan includes the creation of a joint steering committee, and the potential use of third-party contract development and manufacturing organization carry out such activities unless otherwise agreed. Merck will reimburse ModeX for development costs incurred as part of this research plan. To date, we have incurred $26.1 million of development costs related to the Epstein-Barr Virus, which Merck has reimbursed in full.

Current wording

ModeX and Merck have established a strategic collaboration with a detailed research plan to guide the development of such a vaccine or related product. This plan includes the creation of a joint steering committee, and the potential use of third-party contract development and manufacturing organization to carry out such activities unless otherwise agreed. Merck will reimburse ModeX for development costs incurred as part of this research plan. To date, we have incurred $26.5 million of development costs related to the Epstein-Barr Virus, which Merck has reimbursed in full.

Previous wording

In September 2024, ModeX entered into the BARDA Amendment which increased funding by $26.9 million, for the ongoing development, manufacturing, and execution of a Phase 1 clinical trial for a next-generation MSTAR multispecific antibody with broad neutralizing activity against known variants of SARS-CoV-2. The BARDA Amendment also included BARDA's exercise of an option for the development of a multispecific protein antibody for influenza or another pathogen, with the additional funding allocated to cover the expanded work. These modifications increased the total value of the BARDA Contract to $110.0 million, with a potential value, of $205.0 million if BARDA exercises all options thereunder thereunder to expand MOdeX's services. The BARDA Contract covers a five-year period through February 2028. We expect this funding will support the development of a second novel multispecific antibody to SARS-CoV-2, from preclinical through Phase 1 trials, as well as preclinical work on gene-based expression of multispecific antibodies to SARS-CoV-2, including mRNA and/or DNA vectors. In addition, ModeX will begin development of influenza multispecifics with gene and/or protein delivery modalities. As of March 31, 2025, the aggregate amount remaining to be funded by BARDA, which is subject to performance obligations and excluding unexercised contract options, was $78.0 million.

Current wording

In September 2024, ModeX entered into the BARDA Amendment which increased funding by $26.9 million, for the ongoing development, manufacturing, and execution of a Phase 1 clinical trial for a next-generation MSTAR multispecific antibody with broad neutralizing activity against known variants of SARS-CoV-2. The BARDA Amendment also included BARDA's exercise of an option for the development of a multispecific protein antibody for influenza or another pathogen, with the additional funding allocated to cover the expanded work. These modifications increased the total value of the BARDA Contract to $110.0 million, with a potential value, of $205.0 million if BARDA exercises all options thereunder to expand ModeX's services. The BARDA Contract covers a five-year period through February 2028. We expect this funding will support the development of a second novel multispecific antibody to SARS-CoV-2, from preclinical through Phase 1 trials, as well as preclinical work on gene-based expression of multispecific antibodies to SARS-CoV-2, including mRNA and/or DNA vectors. In addition, ModeX will begin development of influenza multispecifics with gene and/or protein delivery modalities. As of June

Previous wording

As of March 31, 2025, the total commitments under our lines of credit with financial institutions in Chile and Spain were $30.9 million, of which $10.7 million was drawn as of March 31, 2025. On March 31, 2025, the weighted average interest rate on these lines of credit was approximately 5.5%. These lines of credit are short-term and are used primarily as a source of working capital. The highest aggregate principal balance at any time outstanding during the three months ended March 31, 2025 was $14.3 million. We intend to continue to draw under these lines of credit as needed. There is no assurance that these lines of credit or other funding sources will be available to us on acceptable terms, or at all, in the future.

Current wording

As of June 30, 2025, the total commitments under our lines of credit with financial institutions in Chile and Spain were$30.9 million, of which$12.5 million was drawn as of June 30, 2025. On June 30, 2025, the weighted average interest rate on these lines of credit was approximately 5.5%. These lines of credit are short-term and are used primarily as a source of working capital. The highest aggregate principal balance at any time outstanding during thesix months ended June 30, 2025 was $14.3 million. We intend to continue to draw under these lines of credit as needed. There is no assurance that these lines of credit or other funding sources will be available to us on acceptable terms, or at all, in the future.

Previous wording

In connection with our agreements with Merck, Pfizer, VFMCRP, and Nicoya, we are eligible to receive various milestone payments and royalty considerations. Under the terms of the Merck Agreement, we received an initial payment of $50.0 million and are also eligible to receive up to an additional $860.0 million upon the achievement of certain commercial and development milestones under several indications. We are also eligible to receive tiered royalty payments ranging from high single digits to low double digits upon achievement of certain sales targets of the Product (as defined in the Merck Agreement). On January 7, 2025, ModeX announced the dosing of the first participant in a Phase 1 study for an EBV vaccine candidate being developed in collaboration with Merck which triggered a $12.5 million milestone payment from Merck under the Merck Agreement. Under the terms of the Restated Pfizer Agreement, we have received or are eligible to receive up to an additional $275.0 million upon the achievement of certain regulatory milestones, including $90 million triggered by the FDA approval in the United States and $85 million due to the commencement of sales of NGENLA (Somatrogon) in Europe and Japan, which we received in 2022. In addition, we are eligible to receive regional, tiered gross profit sharing for both Somatrogon (hGH-CTP) and Pfizer’s Genotropin®. Under the terms of the VFMCRP Agreement, we are entitled to receive up to an additional $15 million in regulatory milestones and $200 million in milestone payments tied to the launch, pricing and sales ofRayaldee, including a $7 million regulatory milestone payment we recorded in the first quarter of 2023 triggered by the German price approval forRayaldee and $3 million regulatory milestone payment we recognized in 2022 following the first sale ofRayaldee in Europe. In addition, we are eligible to receive tiered, double-digit royalty payments. Under the terms of the Nicoya Agreement, we received an initial upfront payment of $5 million and are eligible to receive an aggregate of $5 million tied to the first anniversary of the effective date of the Nicoya Agreement, of which we have received $2.5 million. Furthermore, we received the additional $2.5 million upon Nicoya’s submission of the investigational new drug application to the Center for Drug Evaluation of China in March 2023. We are also eligible to receive up to an additional aggregate amount of $115 million upon the achievement of certain development, regulatory and sales-based milestones by Nicoya for the Nicoya Product in the Nicoya Territory. We are also eligible to receive tiered, double digit royalty payments at rates in the low double digits on net product sales within the Nicoya Territory and in the Nicoya Field.

Current wording

Received an initial payment of $50.0 million.

Previous wording

We believe that the cash, cash equivalents and restricted cash on hand on March 31, 2025 are sufficient to meet our anticipated cash requirements for operations and debt service beyond the next 12 months. We based this estimate on assumptions that may prove to be wrong or are subject to change, and we may be required to use our available cash resources sooner than we currently expect. If we acquire additional assets or companies, accelerate our product development programs or initiate additional clinical trials, we will need additional funds. Our future cash requirements, and the timing of those requirements, will depend on a number of factors, including the approval and success of our products and products in development, particularly our long acting Somatrogon (hGH-CTP) for which we have received approval in over 50 markets, including the United States, Europe, Japan, Australia and Canada, the commercial success ofRayaldee, BioReference’s financial performance, possible acquisitions and dispositions, the continued progress of research and development of our product candidates, the timing and outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing, our success in developing markets for our product candidates and results of government investigations, payor claims, existing legal proceedings (including the ITA litigation) and those that may arise in the future. We have historically not generated sustained positive cash flow and if we are not able to secure additional funding when needed, we may have to delay, reduce the scope of, or eliminate one or more of our clinical trials or research and development programs or possible acquisitions or reduce our marketing or sales efforts or cease operations.

Current wording

We believe that the cash, cash equivalents and restricted cash on hand on June 30, 2025 are sufficient to meet our anticipated cash requirements for operations and debt service beyond the next 12 months. We based this estimate on assumptions that may prove to be wrong or are subject to change, and we may be required to use our available cash resources sooner than we currently expect. If we acquire additional assets or companies, accelerate our product development programs or initiate additional clinical trials, we will need additional funds. Our future cash requirements, and the timing of those requirements, will depend on a number of factors, including the approval and success of our products and products in development, particularly our long acting Somatrogon (hGH-CTP) for which we have received approval in over 50 markets, including the United States, Europe, Japan, Australia and Canada, the commercial success of Rayaldee, BioReference’s financial performance, possible acquisitions and dispositions, the continued progress of research and development of our product candidates, the timing and outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims and other intellectual property rights, the status of competitive products, the availability of financing, our success in developing markets for our product candidates and results of government investigations, payor claims, existing legal proceedings (including the ITA litigation) and those that may arise in the future. We have historically not generated sustained positive cash flow and if we are not able to secure additional funding when needed, we may have to delay, reduce the scope of, or eliminate one or more of our clinical trials or research and development programs or possible acquisitions or reduce our marketing or sales efforts or cease operations.

Previous wording

The preceding table does not include information where the amounts of the obligations are not currently determinable, including the following:

Current wording

The preceding table does not include information with respect to the amounts of obligations that are not currently determinable, including the following: