OPKO HEALTH, INC.

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 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”).

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 NGENLA® (somatrogon-ghla), also referred to as Somatrogon (hGH-CTP), a once-weekly human growth hormone injection. We have partnered with Pfizer Inc. (“Pfizer”) for further development and commercialization of Somatrogon (hGH-CTP). Regulatory approvals for Somatrogon (hGH-CTP) for the treatment of children and adolescents, as young as three years of age, with growth disturbance due to insufficient secretion of growth hormone, have been secured in more than 50 markets worldwide, including in the United States, European Union Member States, Japan, Canada, and Australia under the brand name NGENLA®.

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 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.

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, increasing the program’s aggregate capacity to $200.0 million. As previously reported in the Company’s Form 10‑K, the Company had repurchased 60,383,629 shares of Common Stock for an aggregate cost of approximately $87.2 million as of December 31, 2025. During the three months ended March 31, 2026, the Company repurchased an additional 3,950,000 shares of Common Stock at an average price of $1.21 per share, for an aggregate cost of approximately $4.8 million. As of March 31, 2026, the total cost of repurchases under the program was approximately $92.0 million.

Previous 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.

Current wording

Approximately 32.7% of our revenue for the three months ended March 31, 2026, was denominated in currencies other than the U.S. Dollar (USD). This compares to 22.3% for the same period in 2025. 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, 2026 and the year ended December 31, 2025, 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 $24.1 million and $17.6 million at March 31, 2026 and December 31, 2025, 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 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.

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 March 31, 2026, we held $25.4 million in open foreign exchange forward contracts related to inventory purchases on letters of credit, compared to $13.6 million in open contracts as of December 31, 2025.

Previous 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.

Current wording

Revenue. Revenue from services for the three months ended March 31, 2026 decreased by approximately$30.7 million, a decrease of 29.8% compared to the same period in 2025. This decline was primarily attributable to a $25.9 million reduction in revenue resulting from consummation of the Oncology Transaction in September 2025. The remaining $4.8 million decrease was driven by lower clinical test volumes and clinical test reimbursement rates within our continuing operations.

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 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.

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 three months ended March 31, 2026, we recorded $1.0 million of positive revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods, primarily due to favorable shifts in the composition of our client mix. For the three months ended March 31, 2025, we recorded $1.5 million of negative revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods, primarily due to shifts in the composition of our client and patient pay mix.

Previous 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.

Current wording

Selling, general and administrative expenses. Selling, general and administrative expenses for the three months ended March 31, 2026 and 2025 were$26.2 million and$38.0 million, respectively, representing a decrease of 31.1% from the prior period. This decrease was primarily driven by a $6.5 million reduction in costs associated with divested operations and a $5.3 million decrease resulting from continued cost-reduction initiatives, particularly in lease-related expenses.

Previous 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.

Current wording

Amortization of intangible assets. Amortization of intangible assets was$2.5 million and$3.8 million, respectively, for the three months ended March 31, 2026 and 2025. 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 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.

Current wording

Revenue from transfer of intellectual property and other. Revenue from intellectual property and other increased by $1.7 million to $14.0 million for the three months ended March 31, 2026, from $12.3 million for the same period last year. This increase was primarily driven by higher royalty income and collaboration revenue. Royalty revenue included $6.4 million from NGENLA®, compared to $4.5 million in the 2025 period, and $1.4 million from Eli Lilly. Additionally, we recognized $0.9 million in collaboration revenue from Regeneron during the current period. These gains were partially offset by a decrease in revenue recognized under the BARDA contract, which totaled $4.1 million in the current period compared to $7.0 million for the same period in 2025.

Previous 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.

Current wording

Research and development expenses. Research and development expenses for the three months ended March 31, 2026 and 2025 were$28.8 million and$30.2 million, respectively, a decrease of 4.9% 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

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.

Current wording

Amortization of intangible assets. Amortization of intangible assets was$16.4 million and $16.1 million for the three months ended March 31, 2026 and 2025. 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$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.

Current wording

Operating loss for our unallocated corporate operations was$8.4 million for the three months ended March 31, 2026, compared to$8.5 million for the same period in 2025. These results primarily reflect general and administrative expenses incurred in connection with our corporate operations and remained consistent with the prior year period.

Previous 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.

Current wording

Interest income. Interest income for the three months ended March 31, 2026 and 2025 was$3.0 million and$4.7 million, respectively. The decrease in interest income was primarily driven by lower average interest rates and a lower average balance of cash and cash equivalents invested during the 2026 period compared to the prior year period.

Previous 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.

Current wording

Interest expense. Interest expense decreased to$10.9 million for the three months ended March 31, 2026, compared to$15.5 million for the same period of 2025. The decrease was primarily attributable to lower interest incurred on the 2029 Notes, which accounted for $4.0 million of the reduction. Additionally, interest expense related to our HCRx royalty financing and other international credit facilities decreased by approximately $0.5 million in the aggregate compared to the prior year period. These decreases include the impact of lower principal balances and the related 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 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.

Current wording

Fair value changes of derivative instruments, net. Fair value changes of derivative instruments, net for the three months ended March 31, 2026 and 2025, was$298.0 thousand and$273.0 thousand of income, respectively. Derivative expense was principally related to foreign currency forward exchange contracts at OPKO Chile.

Previous 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.

Current wording

Income tax benefit. Our income tax benefit for the three months ended March 31, 2026 and 2025 was$6.1 million and$5.8 million, respectively. 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 $3.0 thousand for both the three months ended September 30, 2025 and 2024.

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 $2.0 thousand and $9.0 thousand for the three months ended March 31, 2026 and 2025.

Previous wording

On September 30, 2025, we had cash, cash equivalents and restricted cash of approximately$428.9 million. Cash used in operations of$152.6 million for the nine months ended September 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 provided by investing activities was$232.3 million for the nine months ended September 30, 2025 primarily reflected proceeds from the Labcorp sales including escrow released of $197.8 million and $51.7 million in proceeds from the sale of equity securities, offset by a $7.7 million investment in Entera and $9.6 million in capital expenditures. Cash used in financing activities for thenine months ended September 30, 2025 of$99.7 million primarily reflected the re-purchase of Common Stock for $33.5 million and the repurchase of 2029 Convertible 144A Notes for $62.2 million, and net repayments on our lines of credit of $3.7 million. 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 March 31, 2026, we had cash, cash equivalents and restricted cash of approximately$355.6 million. Cash used in operations of$19.3 million for the three months ended March 31, 2026 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 used in investing activities was$1.8 million for the three months ended March 31, 2026 and primarily reflected capital expenditures. Cash used in financing activities for thethree months ended March 31, 2026 of$5.2 million primarily reflected the repurchase of Common Stock for $4.8 million and net repayments on our lines of credit of $0.1 million. 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, sale of assets, as well as credit facilities available to us.

Previous wording

On September 15, 2025, the Company consummated the Oncology Transaction, pursuant to which Labcorp acquired select assets of the Company's subsidiary, BioReference. Labcorp paid to the Company aggregate consideration of $192.5 million, consisting of $173.3 million in cash and an escrow of $19.2 million, subject to certain adjustments as set forth in the Labcorp Asset Purchase Agreement. Labcorp acquired BioReference's oncology diagnostics business and related clinical testing services assets.

Current wording

On September 15, 2025, the Company consummated the Oncology Transaction, pursuant to which Labcorp acquired BioReference's oncology diagnostics and related clinical testing services assets. Labcorp paid to the Company aggregate consideration of $192.5 million, consisting of $173.3 million in cash and an original escrow amount of $19.2 million to be paid , subject to certain adjustments as set forth in the Labcorp Oncology Purchase Agreement. As of March 31, 2026, the escrow account balance was $19.5 million, reflecting the original $19.2 million plus accrued interest. Pursuant to the terms of the agreement, the escrow is scheduled to be released to the Company on the one-year anniversary of the closing date, September 15, 2026, net of any indemnification obligations. Additionally, the Company is eligible to receive up to $32.5 million in performance-based contingent cash consideration, the realization of which is dependent upon the achievement of certain post-closing financial and operational milestones.

Previous 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 $50.6 million shares of Common Stock had 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.

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 $92.0 million of Common Stock had 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 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.

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. This debt retirement significantly reduced our long-term debt obligations and has resulted in lower ongoing interest expense for the current period.

Previous wording

ModeX's services. As of September 30, 2025, the aggregate amount remaining to be funded by BARDA, which is subject to performance obligations and excluding unexercised contract options, was $63.4 million.

Current wording

In September 2024, ModeX entered into two amendments to modify the scope and funding of the BARDA Contract. The BARDA Amendments structured the funding thereunder as cost-plus-fixed-fee, which included a $26.9 million supplement to further advance the development of COVID-19 multispecific antibodies and provided $24.1 million for the development of a multispecific protein antibody for influenza or another pathogen. In December 2025, the Company entered into a further bilateral modification to de-scope all mRNA development-related efforts using SARS-CoV-2 as an antigen model, as these activities were no longer a priority for the U.S. Department of Health and Human Services. As a result, the total value of the BARDA Contract decreased from $110.0 million to $103.5 million, and the total potential value of the overall contract, inclusive of all options, decreased from $205.0 million to $198.5 million. As of March 31, 2026, the aggregate amount remaining to be funded by BARDA, which is subject to performance obligations and excluding unexercised contract options, was $45.7 million.

Previous wording

On July 17, 2024, we completed a private offering of $250 million aggregate principal amount of the 2044 Notes in accordance with the terms of the 2044 Note Purchase Agreement. The 2044 Notes are secured by the Company’s profit share payments from Pfizer, received under the Restated Pfizer Agreement. The 2044 Notes bear interest at the 3-month SOFR plus 7.5%, subject to a minimum interest rate of 4.0% per annum. The 2044 Notes mature in July 2044, with interest-only payments required for the first four years.

Current wording

On July 17, 2024, the Company completed a private offering of $250.0 million aggregate principal amount of the 2044 Royalty Financing Notes. The 2044 Royalty Financing Notes are secured by the Company’s profit share payments from Pfizer under the Restated Pfizer Agreement. The 2044 Royalty Financing Notes bear interest at the three-month SOFR subject to a 4.0% per annum floor, plus 7.5% per annum. The 2044 Royalty Financing Notes mature in July 2044, with interest-only payments required for the first four years of the term.

Previous wording

As of September 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 September 30, 2025. On September 30, 2025, the weighted average interest rate on these lines of credit was approximately 5.4%. 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 thenine months ended September 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.

Current wording

As of March 31, 2026, the total commitments under our lines of credit with financial institutions in Chile and Spain were$30.4 million, of which$8.1 million was drawn as of March 31, 2026. On March 31, 2026, 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 thethree months ended March 31, 2026 was $8.5 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

Eligible for up to an additional $860.0 million upon achieving certain commercial and development milestones under several indications.

Current wording

Milestone Potential: Eligible for up to an additional $860.0 million upon achieving certain commercial and development milestones under several indications.

Previous wording

Potential for tiered royalty payments ranging from high single digits to low double digits upon achieving certain sales targets of the Product.

Current wording

Royalties: Potential for tiered royalty payments ranging from high single digits to low double digits upon achieving certain sales targets of the Product. (as defined in the Merck Agreement)

Previous wording

On January 7, 2025, a $12.5 million milestone payment was triggered by the dosing of the first participant in a Phase 1 study for an EBV vaccine candidate.

Current wording

Historical Milestone: In January 2025, a $12.5 million milestone payment was triggered by the dosing of the first participant in a Phase 1 study for an EBV vaccine candidate.

Previous wording

Eligible to receive $50.0 million in regulatory milestones.

Current wording

Milestone Potential: Eligible to receive $50.0 million in regulatory milestones.

Previous wording

Eligible to receive regional, tiered gross profit sharing for both Somatrogon (hGH-CTP) and Pfizer’s Genotropin®.

Current wording

Profit Sharing: Eligible to receive regional, tiered gross profit sharing for both NGENLA® and Pfizer’s Genotropin®.

Previous wording

Entitled to receive $200 million in milestone payments tied to the launch, pricing, and sales of Rayaldee.

Current wording

Milestone Potential: Eligible to receive up to an additional $15 million in regulatory milestones and $200 million in payments tied to the launch, pricing, and sales of Rayaldee.

Previous wording

Eligible to receive tiered, double-digit royalty payments.

Current wording

Royalties: Eligible to receive tiered, double-digit royalty payments on future sales.

Previous wording

Received a $7 million regulatory milestone payment in the first quarter of 2023, triggered by the German price approval for Rayaldee.

Current wording

Historical Milestones: Received a $7 million regulatory milestone payment in the first quarter of 2023, triggered by the German price approval for Rayaldee and received a $3 million regulatory milestone payment in 2022 following the first sale of Rayaldee in Europe.

Previous wording

Eligible to receive up to an additional aggregate amount of $115 million upon achieving certain development, regulatory, and sales-based milestones by Nicoya for the Nicoya Product in the Nicoya Territory.

Current wording

Milestone Potential: Eligible to receive up to an additional aggregate amount of $115 million upon achieving certain development, regulatory, and sales-based milestones by Nicoya for the Nicoya Product in the Nicoya Territory.

Previous wording

Eligible to receive an aggregate of $5 million tied to the first anniversary of the effective date of the Nicoya Agreement, of which $2.5 million has been received.

Current wording

Remaining Payments: Of the $5 million tied to the first anniversary of the effective date of the Nicoya Agreement, $2.5 million remains eligible to be received.

Previous wording

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

Royalties: 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.

Previous wording

The timing and ultimate receipt of these milestone and royalty payments are subject to the achievement of the specified events and certain risks and uncertainties inherent in drug development and commercialization. For further discussion of these risks, please refer to “Item 1A-Risk Factors” of the Form 10-K for the year ended December 31, 2024.

Current wording

The timing and ultimate receipt of these milestone and royalty payments are subject to the achievement of the specified events and certain risks and uncertainties inherent in drug development and commercialization. For further discussion of these risks, please refer to “Item 1A-Risk Factors” of the Form 10-K.

Previous wording

We believe that the cash, cash equivalents and restricted cash on hand on September 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.

Current wording

We believe that the cash, cash equivalents and restricted cash on hand on March 31, 2026 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, the commercial launch of Mazdutide by our partners, 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

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which modifies the rules on income tax disclosures to require entities to disclose (i) specific categories in the rate reconciliation, (ii) the income or loss from continuing operations before income tax expense or benefit (separated between domestic and foreign) and (iii) income tax expense or benefit from continuing operations (separated by federal, state and foreign). ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state, and local jurisdictions, among other changes. The guidance became effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. ASU 2023-09 should be applied on a prospective basis, but retrospective application is permitted. We are currently evaluating the potential impact of adopting this new guidance on our consolidated financial statements and related disclosures.

Current wording

In December 2023, the FASB issued ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures” (“ASU 2023-09”), which modifies the rules on income tax disclosures to require entities to disclose (i) specific categories in the rate reconciliation, (ii) the income or loss from continuing operations before income tax expense or benefit (separated between domestic and foreign) and (iii) income tax expense or benefit from continuing operations (separated by federal, state and foreign). ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state, and local jurisdictions, among other changes. The guidance is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. ASU 2023-09 should be applied on a prospective basis, but retrospective application is permitted. The Company adopted ASU 2023-09 in the fourth quarter of fiscal year 2025. This guidance was applied prospectively.

Previous wording

In 2021, the Organization for Economic Co-operation and Development (“OECD”) established an inclusive framework on base erosion and profit shifting and agreed on a two-pillar solution (“Pillar Two”) to global taxation, focusing on global profit allocation and a 15% global minimum effective tax rate. On December 15, 2022, the EU member states agreed to implement the OECD’s global minimum tax rate of 15%. The OECD issued Pillar Two model rules and continues to release guidance on these rules. Various participating countries have enacted or have announced plans to enact new tax laws to implement the global minimum tax, some effective beginning 2024. We considered the applicable tax law changes on Pillar Two implementation in the relevant countries, and there is no material impact to our tax results for the period. We anticipate further legislative activity and administrative guidance, and will continue to evaluate the impacts of enacted legislation and pending legislation to enact Pillar Two Model Rules in the non-US tax jurisdictions we operate in.

Current wording

In 2021, the Organization for Economic Co-operation and Development (“OECD”) established an inclusive framework on base erosion and profit shifting and agreed on a two-pillar solution (“Pillar Two”) to global taxation, focusing on global profit allocation and a 15% global minimum effective tax rate. On December 15, 2022, the EU member states agreed to implement the OECD’s global minimum tax rate of 15%. The OECD issued Pillar Two model rules and continues to release guidance on these rules. Various participating countries have enacted or have announced plans to enact new tax laws to implement the global minimum tax, some effective beginning in 2024. We considered the applicable tax law changes on Pillar Two implementation in the relevant countries, and there is no material impact to our tax results for the period. We anticipate further legislative activity and administrative guidance, and will continue to evaluate the impacts of enacted legislation and pending legislation to enact Pillar Two Model Rules in the non-US tax jurisdictions we operate in.