BIOCRYST PHARMACEUTICALS INC
For the period ended Jun 30, 2025. Filed Aug 5, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 5, 2025
BCRX$7.69+0.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-06.
0001628280-25-022658
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-05.
0001628280-25-037795
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 137 previous paragraphs and 156 current paragraphs.
106 unchanged; 25 reworded; 19 added; 5 removed; 1 previous and 6 current paragraphs rearranged.
Tables are not compared: 2 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (19)
Current report
On May 14, 2025, we announced that the FDA accepted our NDA for the use of ORLADEYO in pediatric patients with HAE aged 2 to 11 years. In addition, we announced that the FDA granted priority review of our NDA, with a Prescription Drug User Fee Act (“PDUFA”) target action date of September 12, 2025. We also announced that we filed a line extension application for the use of ORLADEYO oral granules in patients with HAE aged 2 to 11 years with the European Medicines Agency. On June 23, 2025, the FDA extended the PDUFA goal date for our NDA for the use of once-daily ORLADEYO oral granules in pediatric patients with HAE aged 2 to 11 years due to our submission of additional final reports and formulation data, which resulted in a standard three-month extension to the original goal date to provide time for a full review of the submission. The new PDUFA target action date for our NDA is December 12, 2025.
Current report
On May 16, 2025, we announced new real-world evidence on the use of ORLADEYO in adolescents and people with severe HAE showing significant and sustained reductions in HAE attack rates through 18 months of follow-up after beginning treatment with ORLADEYO in both patient populations.
Current report
On May 30, 2025, we announced new data highlighting the reduction in the percentage of days with HAE symptoms among young children initiating berotralstat in our APeX-P trial. We also announced the broad safety and efficacy outcomes observed across all age groups of patients taking ORLADEYO to prevent HAE attacks.
Current report
On June 6, 2025, we announced that, following a positive recommendation from the Zorginstituut Nederland, ORLADEYO was approved in the Netherlands for the routine prevention of HAE attacks in patients aged 12 years and older. We also announced that this reimbursement approval in the Netherlands marks national reimbursement for ORLADEYO across all major European countries, providing HAE patients with access to the first oral, once-daily preventive therapy.
Current report
On June 13, 2025, we announced that the National Institute of Drug and Food Surveillance in Colombia granted approval for ORLADEYO for the prophylaxis of HAE attacks in adults and pediatric patients 12 years of age or older. We have an exclusive collaboration with Pint Pharma GmbH (“Pint Pharma”) to register and promote ORLADEYO in the pan-Latin America region. Under the terms of the agreement, Pint Pharma is responsible for obtaining and maintaining all marketing authorizations and for commercializing ORLADEYO in the region.
Current report
On June 16, 2025, we announced new data on the long-term efficacy and safety of ORLADEYO for the prophylactic treatment of HAE in patients across all age groups, demonstrating sustained reductions in HAE attacks and consistent safety profile.
Current report
On August 4, 2025, we announced that new real-world data from over 350 patients with HAE with normal C1 inhibitor showed substantial reductions in attack rates with ORLADEYO, which we believe reinforces its value for a historically underserved patient segment and provides strong evidence to close gaps in both treatment and reimbursement.
Current report
Neopharmed Gentili S.p.A. Stock Purchase Agreement
Current report
On June 27, 2025, we entered into a stock purchase agreement (the “Stock Purchase Agreement”) with BioCryst Ireland Limited (“BioCryst Ireland”), a private limited company incorporated under the laws of Ireland and a wholly owned subsidiary of the Company, and Neopharmed Gentili S.p.A., a corporation organized under the laws of Italy (“Neopharmed”).
Current report
Under the terms of the Stock Purchase Agreement, we have agreed to sell to Neopharmed all of our equity interests in BioCryst Ireland, which, together with its subsidiaries, holds certain assets, rights, and employees related to our European ORLADEYO business (the “European ORLADEYO Business”). Concurrent with the closing of the transactions contemplated by the Purchase Agreement, we and BioCryst Ireland will amend and restate our existing intellectual property license agreement pursuant to which we will continue to grant to BioCryst Ireland certain rights with respect to ORLADEYO in the territory (the “IP License Agreement”). The terms of the IP License Agreement may also extend to the pediatric line extension of ORLADEYO, subject to certain regulatory approvals. Upon closing of the transaction, Neopharmed will pay us$250.0 million in cash, subject to customary purchase price adjustments. In addition, Neopharmed has agreed to pay us up to$14.0 million if certain revenue milestones are achieved prior to December 31, 2032. Neopharmed will also pay a $15.0 million royalty release fee to RPI 2019 Intermediate Finance Trust. The transaction is expected to close in October 2025, and we plan to use the proceeds from the transaction to retire all remaining outstanding term debt under the Pharmakon Loan Agreement.
Current report
Leadership Changes
Current report
On July 31, 2025, we announced that our President and Chief Executive Officer, Jon Stonehouse, had informed the Board of Directors of his intention to retire on December 31, 2025. The Board appointed Charlie Gayer, the Company’s Chief Commercial Officer, as the Company’s next President, effective August 1, 2025, and the next Chief Executive Officer, effective January 1, 2026. In addition, on July 7, 2025, we announced the appointment of Babar Ghias as the Company’s Chief Financial Officer and Head of Corporate Development.
Current report
Selling, general and administrative expenses for the three months ended June 30, 2025 were $87.4 million compared to $61.2 million for the three months ended June 30, 2024. This increase was primarily driven by $5.9 million of transaction costs related to the sale of our European ORLADEYO Business to Neopharmed, an increase in stock-based compensation expense as a result of the retirement policy adopted in July 2024 and an increase in restricted stock unit awards granted. Further, there was an increase in ORLADEYO related regulatory, safety and quality activities as efforts shifted from development to supporting commercial products, reflecting the program’s commercial progression, as well as increases in variable costs driven by the increase in ORLADEYO sales.
Current report
In April 2025, the Company made a $75.0 million partial prepayment on the outstanding principal amount under the Pharmakon Term Loan resulting in a one-time loss on extinguishment of debt of $4.2 million for the three months ended June 30, 2025.
Current report
Results of Operations (six months ended June 30, 2025 compared to the six months ended June 30, 2024)
Current report
Research and development expenses decreased to $80.7 million for the six months ended June 30, 2025 from $84.1 million for the six months ended June 30, 2024, primarily due to a decrease in Factor D program expenses attributed to the discontinuation and close-out of the Factor D programs, a decrease in berotralstat-related regulatory, safety and quality expenses as efforts shifted to selling, general, and administrative related activities, reflecting the program’s commercial progression, and a change in general and administrative expense allocations. These reductions were partially offset by increased spending on preclinical and early clinical work for avoralstat, BCX17725, and early-phase pipeline programs, primarily due to investigational new drug application-enabling activities. Further, there was an increase in stock-based compensation expense as a result of the retirement policy adopted in July 2024 and an increase in restricted stock unit awards granted.
Current report
Selling, general and administrative expenses for the six months ended June 30, 2025 were $169.9 million compared to $120.7 million for the six months ended June 30, 2024. The increase was primarily driven by $6.4 million of transaction costs related to the sale of our European ORLADEYO Business, an increase from a change in general and administrative expense allocations, an increase in stock-based compensation expense as a result of the retirement policy adopted in July 2024 and an increase in restricted stock unit awards granted. Further, there was an increase in ORLADEYO related regulatory, safety and quality activities as efforts shifted from development to supporting commercial products, reflecting the program’s commercial progression, as well as increases in variable costs driven by the increase in ORLADEYO sales.
Current report
For the six months ended June 30, 2025, interest income was $5.5 million compared to $7.6 million for the six months ended June 30, 2024. The decrease in interest income was primarily the result of an overall decrease in our investment portfolio. Net foreign currency losses were less than $0.1 million for the six months ended June 30, 2025 compared to losses of $0.1 million for the six months ended June 30, 2024.
Current report
In April 2025, the Company made a $75.0 million partial prepayment on the outstanding principal amount under the Pharmakon Term Loan resulting in a one-time loss on extinguishment of debt of $4.2 million for the six months ended June 30, 2025.
Removed paragraphs (5)
Previous report
On February 12, 2025, we announced that Infarmed in Portugal has recommended ORLADEYO for the routine prevention of recurrent attacks of HAE in eligible patients 12 years and older. With this recommendation, ORLADEYO is now reimbursed in all major countries in Western Europe, except the Netherlands, which is expected in the first half of 2025.
Previous report
On February 24, 2025, we announced that a new market tracking survey of 60 HAE treaters showed that 97 percent are considering prescribing ORLADEYO and 59 percent (up from 26 percent 18 months prior) of current prescribers indicate they are extremely likely to prescribe for more of their patients. In addition, we announced that additional real-world studies with ORLADEYO show statistically significant HAE attack rate reductions experienced by patients with C1-inhibitor deficiency and normal C1-inhibitor levels and function. Patient-reported outcomes also showed willingness to change long-term prophylaxis and improved treatment satisfaction across varying levels of attack frequency and severity after ORLADEYO initiation.
Previous report
On February 24, 2025, we reaffirmed that BCX17725 has advanced into clinical trials and that we expect initial data from the program in 2025.
Previous report
On February 24, 2025, we reaffirmed our expectation to advance avoralstat into a clinical trial of patients with DME in 2025 and announced that initial clinical data from the avoralstat program is targeted by the end of 2025.
Previous report
Selling, general and administrative expenses for the three months ended March 31, 2025 were $82.5 million compared to $59.5 million for the three months ended March 31, 2024. This increase was primarily driven by an increase in commercial expenses to support our growing ORLADEYO revenue, our newly launched regions and expanded international operations, and global commercial support activities across finance, human resources, information technology, and supply chain. Further, there was an increase in stock-based compensation expense as a result of the retirement policy adopted in July 2024 and an increase in restricted stock unit awards outstanding, and an increase in general and administrative expenses resulting from a change in general and administrative expense allocations.
Reworded paragraphs (25)
Previous wording
ORLADEYO is an oral capsule, once-daily therapy discovered and developed by us for the prevention of HAE attacks. ORLADEYO is approved in the United States and other global markets for the prevention of HAE attacks in adults and pediatric patients 12 years and older. In addition, the ongoing APeX-P clinical trial, which is complete through the primary endpoint, is continuing to assess an oral granule formulation of ORLADEYO in pediatric patients who are 2 to 11 years of age.
Current wording
ORLADEYO is an oral capsule, once-daily therapy discovered and developed by us for the prevention of HAE attacks. ORLADEYO is approved in the United States and other global markets for the prevention of HAE attacks in adults and pediatric patients 12 years and older. In addition, the ongoing APeX-P clinical trial, which is complete through the primary endpoint, is continuing to assess an oral granule formulation of ORLADEYO in pediatric patients who are 2 to 11 years of age at enrollment.
Previous wording
We have built out our U.S. commercial infrastructure to support the launch and continued commercialization of ORLADEYO in the United States and are continuing to build our commercial infrastructure to support launches in other markets. Based on proprietary analyses of HAE prevalence and market research studies with HAE patients, physicians, and payors in the United States and Europe, and four full years of commercialization experience with ORLADEYO, we anticipate that the global commercial market for ORLADEYO has the potential to reach a global peak of $1 billion in annual net ORLADEYO revenues. We expect approximately 80 percent of our revenue at peak to come from the United States. These expectations are subject to numerous risks and uncertainties that may cause our actual results, performance, or achievements to be materially different. There can be no assurance that our commercialization methods and strategies will succeed, or that the market for ORLADEYO will develop in line with our current expectations. See “Risk Factors—Risks Relating to Our Business—Risks Relating to Drug Development and Commercialization—There can be no assurance that our or our partners’ commercialization efforts, methods, and strategies for our products or technologies will succeed, and our future revenue generation is uncertain” in Part II, Item 1A of this report for further discussion of these risks.
Current wording
We have built out our U.S. commercial infrastructure to support the launch and continued commercialization of ORLADEYO in the United States and are continuing to build our commercial infrastructure to support launches in other markets. Based on proprietary analyses of HAE prevalence and market research studies with HAE patients, physicians, and payors in the United States and Europe, and over four years of commercialization experience with ORLADEYO, we anticipate that the global commercial market for ORLADEYO has the potential to reach a global peak of $1 billion in annual net ORLADEYO revenues. We expect approximately 80 percent of our revenue at peak to come from the United States. These expectations are subject to numerous risks and uncertainties that may cause our actual results, performance, or achievements to be materially different. There can be no assurance that our commercialization methods and strategies will succeed, or that the market for ORLADEYO will develop in line with our current expectations. See “Risk Factors—Risks Relating to Our Business—Risks Relating to Drug Development and Commercialization—There can be no assurance that our or our partners’ commercialization efforts, methods, and strategies for our products or technologies will succeed, and our future revenue generation is uncertain” in Part II, Item 1A of this report for further discussion of these risks.
Previous wording
Revenue from sales of ORLADEYO for the three months ended March 31, 2025 is discussed under “Results of Operations” in this MD&A. Revenue from sales of ORLADEYO in future periods is subject to uncertainties and will depend on several factors, including the success of our and our partners’ commercialization efforts in the United States and elsewhere, the number of new patients switching to ORLADEYO, patient retention and demand, the number of physicians prescribing ORLADEYO, the rate of monthly prescriptions, reimbursement from third-party and government payors, the number of patients receiving free product, our pricing strategy, and market trends. We monitor and analyze this data on an ongoing basis as we continue to commercialize ORLADEYO. For example, during the three months ended March 31, 2025, we converted ORLADEYO patients from free product to paid during the prescription reauthorization period at a much faster rate than expected, on top of continued strong patient demand, generating higher than expected ORLADEYO revenue that we expect will continue through the full year.
Current wording
Revenue from sales of ORLADEYO for the three and six months ended June 30, 2025 is discussed under “Results of Operations” in this MD&A. Revenue from sales of ORLADEYO in future periods is subject to uncertainties and will depend on several factors, including our pending transaction with Neopharmed, as defined and discussed below, for the sale of our European ORLADEYO Business (as described further under “Recent Developments—Neopharmed Gentili S.p.A. Stock Purchase Agreement” below), the success of our and our partners’ commercialization efforts in the United States and elsewhere, the number of new patients switching to ORLADEYO, patient retention and demand, the number of physicians prescribing ORLADEYO, the rate of monthly prescriptions, reimbursement from third-party and government payors, the number of patients receiving free product, our pricing strategy, and market trends. We monitor and analyze this data on an ongoing basis as we continue to commercialize ORLADEYO and adjust our forecasts accordingly.
Previous wording
Our operating expenses are also difficult to predict and depend on several factors, including research and development expenses, drug manufacturing, clinical research activities, the ongoing requirements of our development programs, the costs of commercialization, the availability of capital and direction from regulatory agencies, which are difficult to predict, and the factors discussed in the “Risk Factors” section in Part II, Item 1A of this report. Management may be able to control the timing and level of research and development and selling, general and administrative expenses, but many of these expenditures will occur irrespective of our actions due to contractually committed activities and/or payments.
Current wording
Our operating expenses are also difficult to predict and depend on several factors, including research and development expenses, drug manufacturing, clinical research activities, the ongoing requirements of our development programs, the costs of commercialization, and direction from regulatory agencies, which are difficult to predict, and the factors discussed in the “Risk Factors” section in Part II, Item 1A of this report. Management may be able to control the timing and level of research and development and selling, general and administrative expenses, but many of these expenditures will occur irrespective of our actions due to contractually committed activities and/or payments.
Previous wording
On May 5, 2025, we announced that we have submitted an NDA to the FDA to expand the ORLADEYO label to children with HAE aged 2 to 11 using an oral granule formulation. We also expect to submit regulatory filings in 2025 in global territories, including Europe, Japan and Canada. ORLADEYO would be the first targeted oral prophylactic therapy for children with HAE.
Current wording
On May 5, 2025, we announced that we submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) to expand the ORLADEYO label to children with HAE aged 2 to 11 using an oral granule formulation. We also announced our expectation to submit regulatory filings in 2025 in global territories, including Europe, Japan and Canada. ORLADEYO would be the first targeted oral prophylactic therapy for children with HAE.
Previous wording
On May 5, 2025, we announced that the FDA has cleared our investigational new drug application, which will enable our clinical trial of BCX17725 to enroll patients in the United States. This phase 1 trial is also open in Australia. We also reaffirmed that we expect initial data from the program in 2025.
Current wording
On May 5, 2025, we announced that the FDA has cleared our investigational new drug application, which will enable our clinical trial of BCX17725 to enroll patients in the United States. This phase 1 trial is also open in Australia. In addition, on July 30, 2025, we were notified that the FDA has granted Fast Track designation for BCX17725 for the treatment of Netherton syndrome. On August 4, 2025, we announced that we continue to expect initial data from the program by the end of the year.
Previous wording
On May 5, 2025, we announced that the first clinical trial with suprachoroidal delivery of avoralstat has been granted authorization to proceed in Australia. We also reaffirmed that we expect initial data from patients with DME in 2025.
Current wording
On May 5, 2025, we announced that the first clinical trial with suprachoroidal delivery of avoralstat was granted authorization to proceed in Australia. On August 4, 2025, we announced that we continue to expect initial data from this program by the end of the year.
Previous wording
On April 18, 2025, we made a partial prepayment of $75.0 million of the outstanding principal amount under the Pharmakon Loan Agreement.
Current wording
On April 18, 2025, we made a partial prepayment of $75.0 million of the outstanding principal amount under the Pharmakon Loan Agreement. On July 24, 2025, we made an additional partial prepayment of$50.0 million of the outstanding principal amount under the Pharmakon Loan Agreement.
Previous wording
Cost of product sales for the three months ended March 31, 2025 and 2024 was $4.6 million and $1.3 million, respectively. The increase in cost of product sales was primarily due to the increase in peramivir and ORLADEYO sales.
Current wording
Cost of product sales for the three months ended June 30, 2025 and 2024 was $2.8 million and $1.7 million, respectively. The increase in cost of product sales was primarily due to the increase in peramivir sales and an increase in inventory reserves.
Previous wording
Research and development expenses decreased to $37.3 million forthe three months ended March 31, 2025 from $46.5 million for the three months ended March 31, 2024, primarily due to decreased expenses driven by the discontinuation and close-out of the Factor D programs, BCX10013 and BCX9930, the completion of the majority of Berotralstat clinical development activities in 2024, and a change in general and administrative expense allocations. These decreases were partially offset by an increase in other research, preclinical and development costs, comprised of avoralstat and other early-phase pipeline programs, primarily due to investigational new drug application-enabling activities. Further, there was an increase in stock-based compensation expense as a result of the retirement policy adopted in July 2024 and an increase in restricted stock unit awards outstanding.
Current wording
Research and development expenses increased to $43.4 million for the three months ended June 30, 2025 from $37.6 million for the three months ended June 30, 2024, primarily due to an increase in preclinical and early clinical work for avoralstat, BCX17725, and early-phase pipeline programs, primarily due to investigational new drug application-enabling activities. Further, there was an increase in stock-based compensation expense as a result of the retirement policy adopted in July 2024 and an increase in restricted stock unit awards granted. These increases were partially offset by the discontinuation and close-out of the Factor D programs, and a decrease in berotralstat-related regulatory, safety and quality expenses as efforts shifted to selling, general, and administrative related activities, reflecting the program’s commercial progression.
Previous wording
Research and development expenses include all direct and indirect expenses and are allocated to specific programs at the point of development of a lead product candidate. Direct expenses are charged directly to the program to which they relate, and indirect expenses are allocated based upon internal direct labor hours dedicated to each respective program. Direct expenses consist of compensation for research and development personnel and costs of outside parties to conduct laboratory studies, develop manufacturing processes and manufacture the product candidates, and conduct and manage clinical trials, as well as other costs related to our clinical and preclinical studies. Additionally, direct expenses consist of those costs necessary to discontinue and close out a development program, including termination fees and other commitments. Indirect expenses consist of lab supplies and services, facility expenses, depreciation of development equipment and other overhead of our research and development efforts. Research and development expenses vary according to the number of programs in clinical development and the stage of development of our clinical programs. Later stage clinical programs tend to cost more than earlier stage programs due to the longer length of time of the clinical trials and the higher number of patients enrolled in these clinical trials.
Current wording
Research and development expenses include all direct and indirect expenses relating to research and development and are allocated to specific programs at the point of development of a lead product candidate. Direct expenses are charged directly to the program to which they relate, and indirect expenses are allocated based upon internal direct labor hours dedicated to each respective program. Direct expenses consist of compensation for research and development personnel and costs of outside parties to conduct laboratory studies, develop manufacturing processes and manufacture the product candidates, and conduct and manage clinical trials, as well as other costs related to our clinical and preclinical studies. Additionally, direct expenses consist of those costs necessary to discontinue and close out a development program, including termination fees and other commitments. Indirect expenses consist of lab supplies and services, facility expenses, depreciation of development equipment and other overhead of our research and development efforts. Research and development expenses vary according to the number of programs in clinical development and the stage of development of our clinical programs. Later stage clinical programs tend to cost more than earlier stage programs due to the longer length of time of the clinical trials and the higher number of patients enrolled in these clinical trials.
Previous wording
Interest expense for the three months ended March 31, 2025 was $23.5 million compared to $24.5 million for the three months ended March 31, 2024. Interest expense is primarily comprised of non-cash interest expense due to the amortization of interest associated with the royalty financing obligations and interest expense associated with the borrowings under the Pharmakon Loan Agreement (as defined below), including the amortization of the deferred financing costs, associated with the borrowings under the Pharmakon Loan. The decrease in interest expense was primarily due to the decrease in the effective interest rate related to the Pharmakon Loan Agreement.
Current wording
Interest expense for the three months ended June 30, 2025 was $21.6 million compared to $24.7 million for the three months ended June 30, 2024. Interest expense is primarily comprised of non-cash interest expense due to the amortization of interest associated with the royalty financing obligations and interest expense associated with the borrowings under the Pharmakon Loan Agreement (as defined below), including the amortization of the deferred financing costs, associated with the borrowings under the Pharmakon Loan. The decrease in interest expense was primarily the result of the $75.0 million partial prepayment on the outstanding principal amount under the Pharmakon Term Loan in April 2025, and a decrease in the effective interest rate related to the Pharmakon Loan Agreement.
Previous wording
For the three months ended March 31, 2025, interest income was $3.0 million compared to $4.0 million for the three months ended March 31, 2024. Net foreign currency gains were less than $0.1 million for the three months ended March 31, 2025 compared to losses of $0.1 million for the three months ended March 31, 2024.
Current wording
For the three months ended June 30, 2025, interest income was $2.5 million compared to $3.6 million for the three months ended June 30, 2024. Net foreign currency losses were less than $0.1 million for the three months ended June 30, 2025 and 2024.
Previous wording
For the three months ended March 31, 2025, income tax expense was $0.7 million compared to $0.4 million for the three months ended March 31, 2024. The increase in income tax expense was primarily driven by the increase in net income for the three months ended March 31, 2025 compared to the net loss incurred in the three months ended March 31, 2024.
Current wording
For the three months ended June 30, 2025, income tax expense was $1.4 million compared to $0.2 million for the three months ended June 30, 2024. The increase in income tax expense was primarily driven by the increase in net income for the three months ended June 30, 2025 compared to the net loss incurred in the three months ended June 30, 2024.
Previous wording
For the three months ended March 31, 2025, total revenues were $145.5 million compared to $92.8 million for the three months ended March 31, 2024. The increase in total revenues was due to a $45.4 million increase in ORLADEYO net revenue, excluding royalties, primarily due to an increase in direct sales of ORLADEYO due to both an increase in volume, driven by strong patient demand and an increase in the rate of paid shipments, and an increase in price. The increase in total revenues was also due to an increase in other revenues of $7.3 million, primarily due to an increase in direct sales of peramivir.
Current wording
For the six months ended June 30, 2025, total revenues were $308.9 million compared to $202.1 million for the six months ended June 30, 2024. The increase in total revenues was due to a $93.9 million increase in ORLADEYO net revenue, excluding royalties, primarily due to an increase in direct sales of ORLADEYO due to both an increase in volume, was driven by strong patient demand and an increase in the rate of paid shipments, and an increase in price. The increase in total revenues was also due to an increase in other revenues of $12.9 million, primarily due to an increase in direct sales of peramivir.
Previous wording
On April 17, 2023, we entered into a $450.0 million Loan Agreement (the “Pharmakon Loan Agreement”) with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, as lenders, and BioPharma Credit PLC, as collateral agent for the lenders. The Pharmakon Loan Agreement provides for an initial term loan in the principal amount of $300.0 million (the “Tranche A Loan”), which was funded on April 17, 2023. We utilized the proceeds from the Tranche A Loan to repay the approximate $241.8 million of outstanding indebtedness under the then-existing credit facility with Athyrium Opportunities III Co-Invest 1 LP (the “Athyrium Credit Agreement”) and to pay transaction costs and fees, and we used the remaining net proceeds of approximately $25.8 million for other general corporate purposes. The Pharmakon Loan Agreement also provided for three additional term loan tranches in principal amounts of $50.0 million each, which we could have requested, at our option, on or prior to September 30, 2024. We chose not to request any of the additional term loan tranches and the options have now expired. The maturity date of the Pharmakon Loan Agreement is April 17, 2028. On April 18, 2025, we made a partial prepayment of $75.0 million of the outstanding principal amount under the Pharmakon Loan Agreement.
Current wording
On April 17, 2023, we entered into a $450.0 million Loan Agreement (the “Pharmakon Loan Agreement”) with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, as lenders, and BioPharma Credit PLC, as collateral agent for the lenders. The Pharmakon Loan Agreement provides for an initial term loan in the principal amount of $300.0 million (the “Tranche A Loan”), which was funded on April 17, 2023. We utilized the proceeds from the Tranche A Loan to repay the approximate $241.8 million of outstanding indebtedness under the then-existing credit facility with Athyrium Opportunities III Co-Invest 1 LP (the “Athyrium Credit Agreement”) and to pay transaction costs and fees, and we used the remaining net proceeds of approximately $25.8 million for other general corporate purposes. The Pharmakon Loan Agreement also provided for three additional term loan tranches in principal amounts of $50.0 million each, which we could have requested, at our option, on or prior to September 30, 2024. We chose not to request any of the additional term loan tranches and the options have now expired. The maturity date of the Pharmakon Loan Agreement is April 17, 2028. On April 18, 2025, we made a partial prepayment of $75.0 million of the outstanding principal amount under the Pharmakon Loan Agreement. On July 24, 2025, we made an additional partial prepayment of $50.0 million of the outstanding principal amount under the Pharmakon Loan Agreement. In connection with the closing of the transaction with Neopharmed described above, we plan to use the proceeds from the transaction to retire all remaining outstanding term debt under the Pharmakon Loan Agreement.
Previous wording
Our principal sources of liquidity at March 31, 2025 were approximately $105.2 million in cash and cash equivalents and approximately $210.5 million in available-for-sale investments.
Current wording
Our principal sources of liquidity at June 30, 2025 were approximately $285.2 million in cash and cash equivalents and available-for-sale investments, of which $15.1 million was considered held for sale as of June 30, 2025.
Previous wording
During the three months ended March 31, 2025, net cash used in operating activities of $27.5 million consisted primarily of $62.1 million of changes in operating assets and liabilities, primarily due to a decrease in accounts payable and accrued expenses and an increase in receivables, partially offset by $34.6 million of non-cash items, including $14.1 million of non-cash interest expense and $21.4 million of stock-based compensation expense.
Current wording
During the six months ended June 30, 2025, net cash provided by operating activities of $13.8 million consisted primarily of a net income of $5.1 million and $59.8 million of changes in operating assets and liabilities, primarily due to a decrease in royalty financing obligations and an increase in receivables, offset by $68.4 million of non-cash items, including $26.9 million of non-cash interest expense on royalty financing obligations and $42.7 million of stock-based compensation expense.
Previous wording
During the three months ended March 31, 2024, net cash used in operating activities of $53.7 million consisted primarily of a net loss of $35.4 million and $48.5 million of changes in operating assets and liabilities, primarily due to a decrease in accounts payable and accrued expenses and an increase in accounts receivable, partially offset by $30.2 million of non-cash items, including $19.4 million of non-cash interest expense and $13.7 million of stock-based compensation expense.
Current wording
During the six months ended June 30, 2024, net cash used in operating activities of $55.1 million consisted primarily of a net loss of $48.1 million and $66.8 million of changes in operating assets and liabilities, primarily due to a decrease in accounts payable and accrued expenses, a decrease in royalty financing obligations, and an increase in accounts receivable, partially offset by $59.8 million of non-cash items, including $28.5 million in non-cash interest expense on royalty financing obligations and $26.8 million of stock-based compensation expense.
Previous wording
During the three months ended March 31, 2024, net cash provided by investing activities of $28.8 million primarily related to maturities of investment securities, partially offset by purchases of investment securities.
Current wording
During the six months ended June 30, 2025, net cash provided by investing activities of $56.2 million primarily related to sales and maturities of investment securities, partially offset by purchases of investment securities.
Previous wording
During the three months ended March 31, 2025, net cash provided by investing activities of $27.1 million primarily related to maturities of investment securities, partially offset by purchases of investment securities.
Current wording
During the six months ended June 30, 2024, net cash provided by investing activities of $26.3 million primarily related to maturities of investment securities, partially offset by purchases of investment securities.
Previous wording
During the three months ended March 31, 2025, net cash provided by financing activities of $0.5 million primarily consisted of net proceeds from common stock issued under stock-based compensation plans, partially offset by withholding taxes paid on stock-based awards and principal payments on finance lease liabilities.
Current wording
During the six months ended June 30, 2025, net cash used in financing activities of $73.2 million primarily consisted of repayment of Pharmakon term loan principal and related prepayment premium and fees, and principal payments on royalty financing obligations, partially offset by net proceeds from common stock issued under stock-based compensation plans.
Previous wording
During the three months ended March 31, 2024, net cash used in financing activities of $1.0 million consisted of withholding taxes paid on stock-based awards and principal payments on finance lease liabilities, partially offset by net proceeds from common stock issued under stock-based compensation plans.
Current wording
During the six months ended June 30, 2024, net cash used in financing activities of $3.0 million consisted of withholding taxes paid on stock-based awards and principal payments on finance lease liabilities, partially offset by net proceeds from common stock issued under stock-based compensation plans.
Previous wording
Our inventory primarily relates to ORLADEYO. Additionally, our inventory includes peramivir.
Current wording
Our inventory primarily relates to ORLADEYO. Our inventory also includes peramivir.
Previous wording
All share-based payments, including grants of stock option awards and restricted stock unit awards, are recognized in our Condensed Consolidated Statements of Comprehensive Income (Loss) based on their fair values. Stock-based compensation cost is estimated at the grant date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period of the award. Determining the appropriate fair value model and the related assumptions for the model requires judgment, including estimating the stock price volatility, and the expected term. We utilize the Black-Scholes option-pricing model to value our stock option awards and recognize compensation expense on a straight-line basis over the requisite service period. We reduce stock-based compensation expense for estimated forfeitures. The estimation of share-based payment awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from our current estimates, such amounts will be recorded as a cumulative adjustment in the period estimates are revised. In addition, we have outstanding performance-based restricted stock unit awards for which no compensation expense is recognized until it is probable that the performance condition will be achieved. Actual results, and future changes in estimates, may differ substantially from our current estimates.
Current wording
All share-based payments, including grants of stock option awards and restricted stock unit awards, are recognized in our Condensed Consolidated Statements of Comprehensive Income (Loss) based on their fair values. Stock-based compensation cost is estimated at the grant date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period of the award. Determining the appropriate fair value model and the related assumptions for the model requires judgment, including estimating the stock price volatility, and the expected term. We utilize the Black-Scholes option-pricing model to value our stock option awards and recognize compensation expense on a straight-line basis over the requisite service period. We reduce stock-based compensation expense for estimated forfeitures. The estimation of share-based payment awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from our current estimates, such amounts will be recorded as a cumulative adjustment in the period estimates are revised. Actual results, and future changes in estimates, may differ substantially from our current estimates.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
For the three months ended June 30, 2025, total revenues were $163.4 million compared to $109.3 million for the three months ended June 30, 2024. The increase in total revenues was due to a $48.6 million increase in ORLADEYO net revenue, excluding royalties, primarily due to an increase in direct sales of ORLADEYO due to an increase in volume, which was driven by strong patient demand, and an increase in the rate of paid shipments. The increase in total revenues was also due to an increase in other revenues of $5.5 million, primarily due to an increase in direct sales of peramivir.
Current report — wording carried from elsewhere
Cost of product sales for the six months ended June 30, 2025 and 2024 was $7.4 million and $3.0 million, respectively. The increase in cost of product sales was primarily due to the increase in peramivir and ORLADEYO sales, and an increase in inventory reserves.
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the periods indicated (in thousands):
Current report — wording carried from elsewhere
Research and development expenses include all direct and indirect expenses relating to research and development and are allocated to specific programs at the point of development of a lead product candidate. Direct expenses are charged directly to the program to which they relate, and indirect expenses are allocated based upon internal direct labor hours dedicated to each respective program. Direct expenses consist of compensation for research and development personnel and costs of outside parties to conduct laboratory studies, develop manufacturing processes and manufacture the product candidates, and conduct and manage clinical trials, as well as other costs related to our clinical and preclinical studies. Additionally, direct expenses consist of those costs necessary to discontinue and close out a development program, including termination fees and other commitments. Indirect expenses consist of lab supplies and services, facility expenses, depreciation of development equipment and other overhead of our research and development efforts. Research and development expenses vary according to the number of programs in clinical development and the stage of development of our clinical programs. Later stage clinical programs tend to cost more than earlier stage programs due to the longer length of time of the clinical trials and the higher number of patients enrolled in these clinical trials.
Current report — wording carried from elsewhere
Interest expense for the six months ended June 30, 2025 was $45.1 million compared to $49.2 million for the six months ended June 30, 2024. Interest expense is primarily comprised of non-cash interest expense due to the amortization of interest associated with the royalty financing obligations and interest expense associated with the borrowings under the Pharmakon Loan Agreement (as defined below), including the amortization of the deferred financing costs, associated with the borrowings under the Pharmakon Loan. The decrease in interest expense was primarily the result of the $75.0 million partial prepayment on the outstanding principal amount under the Pharmakon Term Loan in April 2025, and the decrease in the effective interest rate related to the Pharmakon Loan Agreement.
Current report — wording carried from elsewhere
For the six months ended June 30, 2025, income tax expense was $2.1 million compared to $0.5 million for the six months ended June 30, 2024. The increase in income tax expense was primarily driven by the increase in net income for the six months ended June 30, 2025 compared to the net loss incurred in the six months ended June 30, 2024.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
On February 24, 2025, we also announced that we are on track to submit a new drug application (“NDA”) in 2025 to the U.S. Food and Drug Administration (“FDA”) to expand the ORLADEYO label to children with HAE aged 2 to 11 using an oral granule formulation. In addition, we announced positive results from an interim analysis of the ongoing APeX-P clinical trial evaluating an oral granule formulation of ORLADEYO in pediatric patients with HAE aged 2 to 11.