OPKO HEALTH, INC.

Previous wording

Our diagnostics business, BioReference Health, LLC (“BioReference”), is a highly specialized laboratory in the United States, with a sales and marketing team focused on growth and new product integration, including the 4Kscore® prostate cancer test. BioReference® offers a broad spectrum of diagnostic testing services for oncology, urology (4Kscore), and corrections nationwide, setting new standards with our industry-leading turnaround times. BioReference also provides comprehensive clinical and women’s health testing in New York and New Jersey. Our test offerings are backed by a team of board-certified medical professionals and driven by the latest healthcare guidelines and standards marketed directly to physicians, geneticists, hospitals, clinics, correctional facilities, and other healthcare providers. As described below, we entered into agreements with Laboratory Corporation of America Holdings (“Labcorp”) in 2024 and 2025 for the sale of certain BioReference assets, including its oncology testing services.

Current wording

Our diagnostics business, BioReference Health, LLC (“BioReference”), is a highly specialized laboratory in the United States, with a sales and marketing team focused on growth and new product integration, including the 4Kscore® prostate cancer test. BioReference® offers a broad spectrum of diagnostic testing services for urology (4Kscore), and corrections nationwide, setting new standards with our industry-leading turnaround times. BioReference also provides comprehensive clinical and women’s health testing in New York and New Jersey. Our test offerings are backed by a team of board-certified medical professionals and driven by the latest healthcare guidelines and standards marketed directly to physicians, geneticists, hospitals, clinics, correctional facilities, and other healthcare providers.

Previous 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.

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 Common Stock repurchase program, established on July 18, 2024, bringing its aggregate capacity to $200.0 million. As previously reported in the Form 10-K, as of December 31, 2024, the Company had repurchased 25,825,785 shares of Common Stock at an average price per share of $1.56, for a cost of approximately $40.2 million. An additional 24,327,844 shares of Common Stock were repurchased at an average price per share of $1.36, for a cost of approximately $33.5 million during the nine months ended September 30, 2025. As of September 30, 2025, the total cost of repurchases under the program was approximately $73.8 million. Subsequent to the three and nine months ended September 30, 2025, an additional 400,000 shares were retired for a cost of approximately $0.6 million.

Previous 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.

Current wording

Approximately 25.2% of our revenue for the nine months ended September 30, 2025, was denominated in currencies other than the U.S. Dollar (USD). This compares to 22.3% 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 nine months ended September 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 $22.1 million and $52.7 million at September 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 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.

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 September 30, 2025, we held $5.3 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

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.

Current wording

Revenue. Revenue from services for the three months ended September 30, 2025 decreased by approximately$26.0 million, a decrease of 21.5% compared to the same period in 2024. This change was driven by total reductions of $29.5 million composed of $19.9 million reflecting the September 2024 sale of BioReference's lab operations, and $9.6 million from lower clinical test volume in continuing operations, which were partially offset by a $3.5 million increase from higher clinical test reimbursement rates.

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 June 30, 2025, we recorded $0.8 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. For the three months ended June 30, 2024, we recorded $1.4 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 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 both the three months ended September 30, 2025 and 2024, we recorded $0.7 million of negative revenue adjustments. These adjustments were 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.

Previous 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.

Current wording

Cost of revenue. Cost of revenue for the three months ended September 30, 2025 decreased$28.4 million, a decrease of 26.1% compared to the three months ended September 30, 2024. The decrease related predominantly to our disposition of certain lab operations. These divested operations had incurred $24.0 million in cost of revenue for the three months ended September 30, 2024, costs which did not recur for the comparable 2025 period. The remaining decrease primarily reflects lower employee headcount, resulting from both the foregoing divestiture and ongoing cost-reduction initiatives at BioReference, as well as changes in the testing mix for the ongoing operations.

Previous wording

Selling, general and administrative expenses. Selling, general and administrative expenses for the three months ended June 30, 2025 and 2024 were$33.4 million and$44.5 million, respectively, representing a decrease of 25.0% from the prior period. The decrease was primarily driven by the absence of $9.1 million in costs associated with divested operations (which had been incurred for the three months ended June 30, 2024), and lower employee-related expenses resulting from continued cost-reduction initiatives.

Current wording

Selling, general and administrative expenses. Selling, general and administrative expenses for the three months ended September 30, 2025 and 2024 were$31.5 million and$70.9 million, respectively, representing a decrease of 55.6% from the prior period. The decrease was primarily driven by a $32.6 million reduction in employee-related expenses resulting from continued cost-reduction initiatives, and a $7.7 million decrease in costs associated with divested operations, which had been incurred for the three months ended September 30, 2024.

Previous wording

The increase in research and development expenses for the three months ended June 30, 2025 as compared to 2024 was primarily due to changes in ongoing research and development activities offset by 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 three months ended September 30, 2025 as compared to 2024 was primarily due to continued cost-reduction initiatives implemented at BioReference.

Previous 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.

Current wording

Amortization of intangible assets. Amortization of intangible assets was$3.0 million and$3.9 million, respectively, for the three months ended September 30, 2025 and 2024. This decrease was primarily due to the removal of amortizable intangible assets associated with the Oncology Transaction that closed during September 2025.

Previous wording

Revenue from products. Revenue from products for the three months ended June 30, 2025 increased$0.3 million or 0.6%, compared to the three months ended June 30, 2024. The increase was primarily driven by higher sales volume in certain international operations, which contributed an increase of $1.9 million. This positive impact was partially offset by a $1.6 million reduction in sales volume from our Chilean subsidiary, attributable to a mild winter season.

Current wording

Revenue from products. Revenue from products for the three months ended September 30, 2025 decreased$1.5 million or 3.7%, compared to the three months ended September 30, 2024. The decrease was primarily driven by lower sales volume in certain international operations, which resulted in a $3.2 million decrease in revenue. This lower volume was primarily due to unfavorable impacts from the timing of customer orders and product mix. This was partially offset by a $1.7 million increase in revenue from Rayaldee, which increased to $7.5 million from $5.8 million in the 2024 period.

Previous 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.

Current wording

Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $5.5 million to $18.7 million for the three months ended September 30, 2025, from $13.2 million for the same period last year. This growth was primarily driven by the $2.6 million increase from the BARDA Contract (as defined and described in Note 14 to our Quarterly Financial Statements), with revenue of $8.2 million for the three months ended September 30, 2025, compared to $5.5 million for the 2024 period. Additionally, we had an increase of $1.8 million from gross profit share and royalty payments from NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), growing to $8.8 million from $7.0 million in the prior year. Furthermore, contract manufacturers' commercial milestones contributed to a $1.6 million increase, rising to $1.7 million from $0.1 million in the prior year.

Previous wording

Selling, general and administrative expenses. Selling, general and administrative expenses (SG&A) for the three months ended June 30, 2025 and 2024 were$13.2 million and$14.1 million, respectively, a decrease of 6.2% from the prior year period. The decrease was primarily driven by lower employee-related expenses, mainly associated with Rayaldee commercial operations and also from our international operations.

Current wording

Selling, general and administrative expenses. Selling, general and administrative expenses for the three months ended September 30, 2025 and 2024 were$13.1 million and$15.2 million, respectively, a decrease of 13.9% from the prior year period. The decrease was primarily driven by lower employee-related expenses, mainly associated with Rayaldee commercial operations and a decrease in professional fees from our international operations primarily related to tax litigation.

Previous 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.

Current wording

Research and development expenses. Research and development expenses for the three months ended September 30, 2025 and 2024 were$29.6 million and$28.2 million, respectively, an increase of 5.0% 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

Research and development expenses for the three months ended June 30, 2025 increased primarily due to higher expenses at ModeX, driven by growth in our BARDA collaboration and advancements and expansion in our early-stage programs. This increase also reflected higher employee costs due to an increase in headcount.

Current wording

Research and development expenses for the three months ended September 30, 2025 increased primarily due to higher expenses at ModeX, driven by growth in our BARDA collaboration and advancements and expansion in our early-stage programs.

Previous wording

Amortization of intangible assets. Amortization of intangible assets was$16.4 million for both the three 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.

Current wording

Amortization of intangible assets. Amortization of intangible assets was$16.5 million for both the three months ended September 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 was$13.1 million for the three months ended June 30, 2025, compared to$10.3 million for the same period in 2024. This increase was primarily due to higher employee-related expenses, and principally reflects general and administrative expenses incurred in connection with our corporate operations.

Current wording

Operating loss for our unallocated corporate operations was$9.4 million for the three months ended September 30, 2025, compared to$12.1 million for the same period in 2024. This decrease was primarily due to lower employee-related expenses, and principally reflects general and administrative expenses incurred in connection with our corporate operations.

Previous wording

Interest income. Interest income for the six months ended June 30, 2025 and 2024 was $8.0 million and $1.2 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 September 30, 2025 and 2024 was$3.0 million and$2.9 million, respectively. The increase in interest income was primarily driven by interest earned on a larger average balance of cash and cash equivalents invested during the 2025 period.

Previous wording

Interest expense. Interest expense increased to$70.3 million for the three months ended June 30, 2025, compared to$8.2 million in the same period of 2024. The increase was attributable to the amortization of $54.7 million in unamortized debt discount and $4.4 million in debt issuance costs related to the Note Exchange Transactions (as defined in Note 7 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q). In addition, interest expense was impacted by $3.4 million interest incurred on the 2029 Convertible Notes and the 2044 Notes, including amortization of deferred financing and debt issuance costs.

Current wording

Interest expense. Interest expense decreased to$11.4 million for the three months ended September 30, 2025, compared to$17.4 million for the same period of 2024. The decrease was attributable to lower interest incurred on the 2029 Convertible 144A Notes and the 2044 Notes, including amortization of deferred financing and debt issuance costs.

Previous wording

Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the three months ended June 30, 2025 and 2024, was$16.0 thousand and$1.0 thousand of income, respectively. Derivative income was principally related to 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 three months ended September 30, 2025 and 2024, was$38.0 thousand and$1.0 thousand of income, respectively. Derivative income was principally related to foreign currency forward exchange contracts at OPKO Chile.

Previous wording

Other income (expense), net. Other income (expense), net decreased by$94.4 million to$35.5 million expense for the three months ended June 30, 2025, compared to$58.9 million in income during the prior year period. This was primarily driven by $60.5 million in income recorded in the prior year period as a result of the change in the fair value of our investment in GeneDx Holdings (as defined in Note 6 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q), which did not recur in the current period. Additionally, the three 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 $2.6 million was recorded for the 2025 period, compared with a $1.3 million loss in the 2024 period.

Current wording

Other income (expense), net. Other income (expense), net decreased by$46.9 million to$1.7 million expense for the three months ended September 30, 2025, compared to$48.6 million in income during the prior year period. In the 2024 period, we recorded income of $45.9 million from our investment in GeneDx Holdings (as defined in Note 6 to our Quarterly Financial Statements contained in this Quarterly Report on Form 10-Q), consisting of $35.4 million of income related to changes in the fair value and $10.5 million income from the sale of shares. Foreign currency income was $1.1 million for the 2025 period, compared with $4.1 million income recorded in the 2024 period.

Previous 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.

Current wording

Income tax provision. Our income tax provision for the three months ended September 30, 2025 and 2024 was$19.8 million and$23.5 million, respectively. The $3.7 million decrease in the provision was primarily drive by the discrete, non-recurring tax expenses related to the BioReference Transaction and the Oncology Transaction. While the U.S. federal statutory income tax rate is 21%, our consolidated effective tax rate for both periods differed from this rate primarily due to the relative mix of earnings and losses generated in the U.S. versus foreign tax jurisdictions, as well as the 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 $9.0 thousand and $3.0 thousand for the six months ended June 30, 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 $3.0 thousand for both the three months ended September 30, 2025 and 2024.

Previous wording

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

Current wording

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

Previous wording

Revenue. Revenue from services for the six months ended June 30, 2025 decreased by approximately $52.3 million, a decrease of 20.4% compared to the same period in 2024. The decrease resulted from revenue reductions totaling $71.0 million, composed of $52.4 million due to the absence of revenue following the BioReference Transaction and $18.6 million from lower clinical test volume in continuing operations. These decreases were partially offset by an $18.7 million increase attributed to higher clinical test reimbursement rates.

Current wording

Revenue. Revenue from services for the nine months ended September 30, 2025 decreased by approximately $78.4 million, a decrease of 20.8% compared to the same period in 2024. This change was driven by total reductions of $100.6 million, composed of $72.3 million reflecting the September 2024 sale of BioReference's lab operations, and $28.3 million from lower clinical test volume in continuing operations, which were partially offset by a $22.2 million increase from higher clinical test reimbursement rates.

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 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.

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 nine months ended September 30, 2025 and 2024, we recorded $1.3 million and $2.2 million, respectively, of negative revenue adjustments due to changes in estimates of implicit price concessions for services provided in prior periods, primarily due to shifts in the composition of our client and patient pay mix.

Previous wording

The composition of revenue from services by payor for the six months ended June 30, 2025 and 2024 was as follows:

Current wording

The composition of revenue from services by payor for the nine months ended September 30, 2025 and 2024 was as follows:

Previous wording

Cost of revenue. Cost of revenue for the six months ended June 30, 2025 decreased $50.1 million, a decrease of 23.1% compared to the six 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 $47.9 million in cost of revenue for the six 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.

Current wording

Cost of revenue. Cost of revenue for the nine months ended September 30, 2025 decreased $78.5 million, a decrease of 24.1% compared to the nine months ended September 30, 2024. The decrease is related predominantly to our disposition of certain lab operations in the BioReference Transaction. These divested operations had incurred $71.9 million in cost of revenue for the nine months ended September 30, 2024, costs which did not recur for the comparable 2025 period. The remaining decrease primarily reflects lower employee headcount, resulting from both the foregoing divestiture and ongoing cost-reduction initiatives at BioReference, as well as changes in the testing mix for the ongoing operations.

Previous 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.

Current wording

Selling, general and administrative expenses. Selling, general and administrative expenses for the nine months ended September 30, 2025 and 2024 were $102.8 million and $161.2 million, respectively, representing a decrease of 36.2% from the prior period. The decrease was driven by lower employee-related expenses resulting from continued cost-reduction initiatives and the absence of $26.8 million in costs associated with divested operations (which had been incurred for the nine months ended September 30, 2024). These favorable impacts, which reduced ongoing expenses, were partially offset by $4.7 million in one-time costs recorded for the nine months ended September 30, 2025 related to adjustments to the useful life of certain operating leases.

Previous 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.

Current wording

The decrease in research and development expenses for the nine months ended September 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

Amortization of intangible assets. Amortization of intangible assets was $6.8 million and$9.0 million, respectively, for the six months ended June 30, 2025 and 2024. This decrease is 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.

Current wording

Amortization of intangible assets. Amortization of intangible assets was $9.8 million and$12.9 million, respectively, for the nine months ended September 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 assets included in the Oncology Transaction (defined in Note 1 to our Condensed Consolidated Financial Statements contained in this Quarterly Report on Form 10-Q).

Previous 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.

Current wording

Revenue from products. Revenue from products for the nine months ended September 30, 2025 decreased $4.4 million or 3.8%, compared to the nine months ended September 30, 2024. The decrease was primarily driven by lower sales volume in our international operations, which resulted in a $5.5 million decrease in revenue. This decrease was impacted primarily by unfavorable foreign exchange of $1.1 million, as well as the timing of customer orders and product mix. This negative impact was partially offset by a $1.1 million increase in revenue from Rayaldee, which grew to $21.0 million compared to $19.9 million in the 2024 period.

Previous wording

Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $6.2 million to $27.2 million for the six months ended June 30, 2025, from $21.1 million in the same period last year. This increase was primarily driven by a $6.3 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 recognized under the contract totaling $13.5 million for the six months ended June 30, 2025 compared to $7.2 million in the 2024 period. Additionally, contract manufacturers' commercial milestones contributed a $2.5 million increase, rising to $2.9 million from $0.4 million in the prior year. These gains were partially offset by a $1.3 million reduction in gross profit share and royalty payments from NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), which totaled $10.6 million for the six months ended June 30, 2025 compared to $11.9 million in 2024.

Current wording

Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $11.7 million to $46.0 million for the nine months ended September 30, 2025, from $34.3 million in the same period last year. The increase was primarily driven by a $8.9 million increase from the BARDA Contract, with revenue recognized under the contract totaling $21.6 million for the nine months ended September 30, 2025, compared to $12.8 million for the 2024 period. Additionally, contract manufacturers' commercial milestones contributed a $4.1 million increase, rising to $4.6 million from $0.5 million in the prior year. Furthermore, we had an increase of $0.5 million from gross profit share and royalty payments from NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), growing to $19.4 million from $18.9 million in the prior year. These positive factors were partially offset by a net decrease of $1.8 million from other revenue during the period.

Previous wording

Research and development expenses. Research and development expenses for the six months ended June 30, 2025 and 2024 were $60.0 million and $44.9 million, respectively, an increase of 33.6% 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 nine months ended September 30, 2025 and 2024 were $89.7 million and $73.2 million, respectively, an increase of 22.5% 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

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.

Current wording

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

Previous 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.

Current wording

Amortization of intangible assets. Amortization of intangible assets was $49.1 million and $49.4 million, respectively, for the nine months ended September 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 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.

Current wording

Operating loss for our unallocated corporate operations for the nine months ended September 30, 2025 and 2024 was 31.0 million and $31.8 million, respectively, and principally reflects general and administrative expenses incurred in connection with our corporate operations. The decrease in operating loss was primarily due to lower employee-related expenses.

Previous 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.

Current wording

Interest income. Interest income for the nine months ended September 30, 2025 and 2024 was $11.0 million and $4.1 million, respectively. The increase in interest income is driven by interest earned on our larger cash investment.

Previous wording

Interest expense. Interest expense increased to $85.8 million for the six months ended June 30, 2025, compared to $15.9 million for the same period of 2024. The increase was primarily attributable to $59.1 million from the amortization of $54.7 million in unamortized debt discount and $4.4 million in debt issuance costs related to the Note Exchange Transactions (as defined in Note 7 to our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q). In addition, interest expense was impacted by $11.5 million interest incurred on the 2029 Convertible Notes and the 2044 Notes, including amortization of deferred financing and debt issuance costs.

Current wording

Interest expense. Interest expense increased to $97.2 million for the nine months ended September 30, 2025, compared to $33.2 million for the same period of 2024. The increase was primarily attributable to $59.1 million from the amortization of $54.7 million in unamortized debt discount and $4.4 million in debt issuance costs related to the Note Exchange Transactions (as defined in Note 7 to our Condensed Consolidated Financial Statements contained in this Quarterly Report on Form 10-Q). In addition, interest expense was impacted by $8.1 million interest incurred on the 2029 Convertible Notes and the 2044 Notes, including amortization of deferred financing and debt issuance costs.

Previous 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.

Current wording

Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the nine months ended September 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 Sstatements contained in this Quarterly Report on Form 10-Q for further information) and on foreign currency forward exchange contracts at OPKO Chile.