INSMED Inc
For the period ended Sep 30, 2024. Filed Oct 31, 2024.
View on SEC.govAbout this filing
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.
Sep 30, 2024 · Filed Oct 31, 2024
INSM$114.41+5.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0001104506-24-000026
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-10-31.
0001104506-24-000033
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 217 previous paragraphs and 221 current paragraphs.
158 unchanged; 50 reworded; 12 added; 8 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 11 previous and 11 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 (12)
Current report
•In June 2024, we met and aligned with the FDA on the primary endpoint for the ENCORE study. If the data are positive, ENCORE may support a label expansion to include all MAC lung patients as well as support full approval for the current refractory indication. In September 2024, we closed screening of new patients in the ENCORE study which we expect will result in us exceeding our target enrollment of 400 patients in the study.
Current report
Japan.
Current report
•R&D expenses increased $41.7 million as compared to the same period in the prior year primarily as a result ofincreases in manufacturing and compensation and benefit-related expenses;
Current report
•Investment income increased $6.4 million as compared to the same period in the prior year primarily due to an increase in our average cash and cash equivalents and marketable securities balances; and
Current report
•Interest expense increased $0.8 million as compared to the same period in the prior year due to the Term Loan.
Current report
R&D expenses increased to $150.8 million during the three months ended September 30, 2024 from $109.1 million in the same period in 2023. The $41.7 million increase in R&D expenses was due to a $20.3 million increase in manufacturing expense and an $18.7 million increasein compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount.
Current report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Current report
•Investment income increased $3.8 million as compared to the same period in the prior year due to an increase in our average cash and cash equivalents and marketable securities balances; and
Current report
•Interest expense increased$2.5 million as compared to the same period in the prior year due to the Term Loan.
Current report
Cost of product revenues (excluding amortization of intangible assets) for the nine months ended September 30, 2024 and 2023 were comprised of the following (in thousands):
Current report
R&D expenses for the nine months ended September 30, 2024 and 2023 were comprised of the following (in thousands):
Current report
SG&A expenses for the nine months ended September 30, 2024 and 2023 were comprised of the following (in thousands):
Removed paragraphs (8)
Previous report
•In June 2024, we met and aligned with the FDA on the primary endpoint for the ENCORE study. If the data are positive, ENCORE may support a label expansion to include all MAC lung patients as well as support full approval for the current refractory indication. We are targeting enrollment of 400 patients in the ENCORE study.
Previous report
•R&D expenses decreased $50.2 million as compared to the same period in the prior year primarily as a result of the non-cash cost of the Adrestia acquisition in the second quarter of 2023;
Previous report
•Interest expense increased $0.6 million as compared to the same period in the prior year due to the Term Loan.
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2023
Previous report
•Interest expense increased$1.7 million as compared to the same period in the prior year due to the Term Loan.
Previous report
Cost of product revenues (excluding amortization of intangible assets) for the six months ended June 30, 2024 and 2023 were comprised of the following (in thousands):
Previous report
R&D expenses for the six months ended June 30, 2024 and 2023 were comprised of the following (in thousands):
Previous report
SG&A expenses for the six months ended June 30, 2024 and 2023 were comprised of the following (in thousands):
Reworded paragraphs (50)
Previous wording
Our pipeline includes clinical-stage programs brensocatib and TPIP, as well as other early-stage research programs. Brensocatib is a small molecule, oral, reversible inhibitor of DPP1, which we are developing for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases, including CRSsNP and HS. TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PH-ILD and PAH. Our early-stage research programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
Current wording
Our pipeline includes clinical-stage programs brensocatib and TPIP, as well as early-stage research programs. Brensocatib is a small molecule, oral, reversible inhibitor of DPP1, which we are developing for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases, including CRSsNP and HS. TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PH-ILD and PAH. Our early-stage research programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
Previous wording
•We announced positive topline results from the ASPEN trial in May 2024. The study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of adjudicated pulmonary exacerbations (PEs) versus placebo. We plan to file an NDA with the FDA for brensocatib in patients with bronchiectasis in the fourth quarter of 2024, followed by filings with the European and Japanese regulatory authorities.
Current wording
•We announced positive topline results from the ASPEN trial in May 2024. The study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of adjudicated pulmonary exacerbations (PEs) versus placebo.
Previous wording
•We are advancing commercial readiness activities in preparation for a launch of brensocatib for patients with bronchiectasis, if approved. If successful, we anticipate a launch in the US in mid-2025, followed by launches in Europe and Japan in the first half of 2026.
Current wording
•We remain on track to file an NDA with the FDA for brensocatib in patients with bronchiectasis in the fourth quarter of 2024. We are advancing commercial readiness activities in preparation for a launch of brensocatib for patients with bronchiectasis, if approved. If a priority review is granted and brensocatib is approved, Insmed anticipates a US launch in mid-2025. Launches in Europe and Japan are expected in the first half of 2026, pending approvals.
Previous wording
•We are exploring the potential of brensocatib in additional neutrophil-mediated diseases. The Phase 2b BiRCh trial of brensocatib in patients with CRSsNP is underway and we expect to initiate a Phase 2 study of brensocatib in patients with HS in the second half of 2024.
Current wording
•We are conducting further studies to explore the potential of brensocatib in additional neutrophil-mediated diseases. The Phase 2b BiRCh trial of brensocatib in patients with CRSsNP is underway and we expect to initiate a Phase 2 study of brensocatib in patients with HS in the fourth quarter of 2024.
Previous wording
•Enrollment in the Phase 2 study of TPIP in PAH remains ongoing. We anticipate topline results in 2025.
Current wording
•Enrollment in the Phase 2 study of TPIP in PAH remains ongoing. We anticipate topline results in the second half of 2025.
Previous wording
•In May 2024, we reported topline safety data and certain exploratory efficacy endpoints from the Phase 2 study of TPIP in patients with PH-ILD. Based on these Phase 2 results in PH-ILD, we are advancing toward discussions with global regulatory authorities on the design of a Phase 3 study in PH-ILD, which we anticipate initiating in 2025.
Current wording
•In May 2024, we reported topline safety data and certain exploratory efficacy endpoints from the Phase 2 study of TPIP in patients with PH-ILD. Based on these Phase 2 results in PH-ILD, we are advancing toward discussions with global regulatory authorities on the design of a Phase 3 study in PH-ILD, which we anticipate initiating in the second half of 2025.
Previous wording
As a condition of accelerated approval, we must conduct a post-marketing confirmatory clinical trial. In December 2020, we commenced the post-marketing confirmatory clinical trial program for ARIKAYCE in patients with MAC lung disease consisting of the ARISE trial, an interventional study designed to validate cross-sectional and longitudinal characteristics of a PRO tool in MAC lung disease, and the ENCORE trial, designed to establish the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed or recurrent MAC lung infection who have not started antibiotics using the PRO tool validated in the ARISE trial. In September 2023, we announced positive topline results from the ARISE trial. The study met its primary objective of demonstrating that the QOL-B respiratory domain works effectively as a PRO tool in patients with MAC lung disease. Based on these results, we have proposed to the FDA that the change of the respiratory score derived from the QOL-B respiratory domain PRO be the primary endpoint for the ENCORE study. In June 2024, we met and aligned with the FDA on the primary endpoint for the ENCORE study. If the data are positive, ENCORE may support a label expansion to include all MAC lung patients as well as support full approval for the current refractory indication. Based on feedback and in alignment with the FDA, we have determined that the primary endpoint for the ENCORE study will include 8 questions from the QOL-B respiratory domain PRO. We are targeting enrollment of 400 patients in the ENCORE study and expect to report topline data in the first quarter of 2026.
Current wording
As a condition of accelerated approval, we must conduct a post-marketing confirmatory clinical trial. In December 2020, we commenced the post-marketing confirmatory clinical trial program for ARIKAYCE in patients with MAC lung disease consisting of the ARISE trial, an interventional study designed to validate cross-sectional and longitudinal characteristics of a PRO tool in MAC lung disease, and the ENCORE trial, designed to establish the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed or recurrent MAC lung infection who have not started antibiotics using the PRO tool validated in the ARISE trial. In September 2023, we announced positive topline results from the ARISE trial. The study met its primary objective of demonstrating that the QOL-B respiratory domain works effectively as a PRO tool in patients with MAC lung disease. Based on these results, we have proposed to the FDA that the change of the respiratory score derived from the QOL-B respiratory domain PRO be the primary endpoint for the ENCORE study. In June 2024, we met and aligned with the FDA on the primary endpoint for the ENCORE study. If the data are positive, ENCORE may support a label expansion to include all MAC lung patients as well as support full approval for the current refractory indication. Based on feedback and in alignment with the FDA, we have determined that the primary endpoint for the ENCORE study will include 8 questions from the QOL-B respiratory domain PRO. In September 2024, we closed screening of new patients in the ENCORE study which we expect will result in us exceeding our target enrollment of 400 patients in the study. Weanticipate reporting topline datain the first quarter of 2026.
Previous wording
Accelerated approval of ARIKAYCE was supported by preliminary data from the CONVERT study, a global Phase 3 study evaluating the safety and efficacy of ARIKAYCE in adult patients with refractory MAC lung disease, using achievement of sputum culture conversion (defined as three consecutive negative monthly sputum cultures) by Month 6 as the primary endpoint. Patients who achieved sputum culture conversion by Month 6 continued in the CONVERT study for an additional 12 months of treatment following the first monthly negative sputum culture in order to assess the durability of culture conversion, as defined by patients that have completed treatment and continued in the CONVERT study off all therapy for three months. In May 2019, we presented at the American Thoracic Society meeting that 41/65 (63.1%) of patients on ARIKAYCE plus GBT who had achieved culture conversion by Month 6 had maintained durable culture conversion for three months off all therapy compared to 0/10 (0%) on GBT only (p<0.0002). Safety data for these patients were consistent with safety data previously reported for patients by Month 6 of the CONVERT study.
Current wording
Accelerated approval of ARIKAYCE was supported by preliminary data from the CONVERT study, a global Phase 3 study evaluating the safety and efficacy of ARIKAYCE in adult patients with refractory MAC lung disease, using achievement of sputum culture conversion (defined as three consecutive negative monthly sputum cultures) by Month 6 as the primary endpoint. Patients who achieved sputum culture conversion by Month 6 continued in the CONVERT study for an additional 12 months of treatment following the first monthly negative sputum culture in order to assess the durability of culture conversion, as defined by patients that have completed treatment and continued in the CONVERT study off all therapy for three months. In
Previous wording
The ENCORE trial is a randomized, double-blind, placebo-controlled Phase 3b study to evaluate the efficacy and safety of an ARIKAYCE-based regimen in patients with newly diagnosed or recurrent MAC infection who have not started antibiotics. Patients are randomized 1:1 to receive ARIKAYCE plus background regimen or placebo plus background regimen once daily for 12 months. Patients will then discontinue all study treatments and remain in the trial for three months for the assessment of durability of culture conversion. The primary endpoint is change from baseline to Month 13 in respiratory symptom score. The key secondary endpoint is the proportion of subjects achieving durable culture conversion at Month 15. In June 2024, we met and aligned with the FDA on the primary endpoint for the ENCORE study. If the data are positive, ENCORE may support a label expansion to include all MAC lung patients as well as support full approval for the current refractory indication. Based on feedback and in alignment with the FDA, we have determined that the primary endpoint for the ENCORE study will include 8 questions from the QOL-B respiratory domain PRO. We are targeting enrollment of 400 patients in the ENCORE study and expect to report topline data in the first quarter of 2026.
Current wording
The ENCORE trial is a randomized, double-blind, placebo-controlled Phase 3b study to evaluate the efficacy and safety of an ARIKAYCE-based regimen in patients with newly diagnosed or recurrent MAC infection who have not started antibiotics. Patients are randomized 1:1 to receive ARIKAYCE plus background regimen or placebo plus background regimen once daily for 12 months. Patients will then discontinue all study treatments and remain in the trial for three months for the assessment of durability of culture conversion. The primary endpoint is change from baseline to Month 13 in respiratory symptom score. The key secondary endpoint is the proportion of subjects achieving durable culture conversion at Month 15. In June 2024, we met and aligned with the FDA on the primary endpoint for the ENCORE study. If the data are positive, ENCORE may support a label expansion to include all MAC lung patients as well as support full approval for the current refractory indication. Based on feedback and in alignment with the FDA, we have determined that the primary endpoint for the ENCORE study will include 8 questions from the QOL-B respiratory domain PRO. In September 2024, we closed screening of new patients in the ENCORE study which we expect will result in us exceeding our target enrollment of 400 patients in the study. Weanticipate reporting topline datain the first quarter of 2026.
Previous wording
In October 2021, the EMA’s Paediatric Committee approved the brensocatib Pediatric Investigational Plan for the treatment of patients with NCFBE. As a result, the ASPEN trial includes 41 adolescent patients between ages 12 to 17, which will fulfill the pediatric study requirements to support marketing applications in this patient population in the US, Europe and Japan.
Current wording
In October 2021, the EMA’s Paediatric Committee approved the brensocatib Pediatric Investigational Plan for the treatment of patients with NCFBE. As a result, the ASPEN trial includes 41 adolescent patients between ages 12 to 17, which will fulfill the pediatric study requirements to support marketing applications in this patient population in the US, Europe and
Previous wording
We announced positive topline results from the ASPEN trial in May 2024. The primary efficacy analysis included data from 1,680 adult patients and 41 adolescent patients. Brensocatib was well-tolerated in the study. In addition, the study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of adjudicated PEs versus placebo. The study also met several of its prespecified secondary endpoints with statistical significance. We plan to file an NDA with the FDA for brensocatib in patients with bronchiectasis in the fourth quarter of 2024.
Current wording
We announced positive topline results from the ASPEN trial in May 2024. The primary efficacy analysis included data from 1,680 adult patients and 41 adolescent patients. Brensocatib was well-tolerated in the study. In addition, the study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of adjudicated PEs versus placebo. The study also met several of its prespecified secondary endpoints with statistical significance. We remain on track to file an NDA with the FDA for brensocatib in patients with bronchiectasis in the fourth quarter of 2024.
Previous wording
We also plan to explore the potential of brensocatib in additional neutrophil-mediated diseases, including CRSsNP and HS. CRSsNP currently has one approved pharmacological therapy (corticosteriod nasal spray); however, many patients do not respond to corticosteroids or endoscopic sinus surgery. The Phase 2b BiRCh trial of brensocatib in patients with CRSsNP is underway and we expect to initiate a Phase 2 study of brensocatib in patients with HS in the second half of 2024.
Current wording
We are conducting further studies to explore the potential of brensocatib in additional neutrophil-mediated diseases, including CRSsNP and HS. CRSsNP currently has one approved pharmacological therapy (corticosteriod nasal spray); however, many patients do not respond to corticosteroids or endoscopic sinus surgery. The Phase 2b BiRCh trial of brensocatib in patients with CRSsNP is underway and we expect to initiate a Phase 2 study of brensocatib in patients with HS in the fourth quarter of 2024.
Previous wording
In May 2024, we reported topline safety data and certain exploratory efficacy endpoints from the Phase 2 study of TPIP in patients with PH-ILD. Based on these Phase 2 results in PH-ILD, we are advancing toward discussions with global regulatory authorities on the design of a Phase 3 study in PH-ILD, which we anticipate initiating in 2025. We also have an ongoing Phase 2 study designed to investigate the effect of TPIP in patients with PAH. Enrollment in the Phase 2 study of TPIP in PAH remains ongoing and we anticipate topline results in 2025.
Current wording
In May 2024, we reported topline safety data and certain exploratory efficacy endpoints from the Phase 2 study of TPIP in patients with PH-ILD. Based on these Phase 2 results in PH-ILD, we are advancing toward discussions with global regulatory authorities on the design of a Phase 3 study in PH-ILD, which we anticipate initiating in the second half of 2025. We also have an ongoing Phase 2 study designed to investigate the effect of TPIP in patients with PAH. Enrollment in the Phase 2 study of TPIP in PAH remains ongoing and we anticipate topline results in the second half of 2025.
Previous wording
•Product revenues, net, increased$23.4 million, or 16.4%, as compared to the same period in the prior year as a result of the growth in ARIKAYCE sales;
Current wording
•Product revenues, net, increased$14.4 million, or 18.2%, as compared to the same period in the prior year as a result of the growth in ARIKAYCE sales;
Previous wording
•Cost of product revenues (excluding amortization of intangible assets) increased$4.4 million as compared to the same period in the prior year as a result of the increase in sales volumes of ARIKAYCE;
Current wording
•Cost of product revenues (excluding amortization of intangible assets) increased$4.5 million as compared to the same period in the prior year as a result of the increase in sales volumes of ARIKAYCE;
Previous wording
•SG&A expenses increased $22.1 million as compared to the same period in the prior year primarily as a result of increases in compensation and benefit-related expensesand stock-based compensation costs;
Current wording
•SG&A expenses increased $28.3 million as compared to the same period in the prior year primarily as a result of increases in compensation and benefit-related expensesand stock-based compensation costs;
Previous wording
•Change in fair value of deferred and contingent consideration liabilities increased $90.2 million, primarily as a result of the change in our share price; and
Current wording
•Change in fair value of deferred and contingent consideration liabilities increased $5.7 million, primarily as a result of the change in our share price;
Previous wording
Product revenues, net, for the three months ended June 30, 2024 increased to $90.3 million as compared to $77.2 million in the same period in 2023, an increase of 17.0%, as a result of growth in ARIKAYCE sales in the US, Japan and Europe and the rest of the world.
Current wording
Product revenues, net, for the three months ended September 30, 2024 increased to $93.4 million as compared to $79.1 million in the same period in 2023, an increase of 18.2%, as a result of growth in ARIKAYCE sales in the US, Japan and Europe and the rest of the world.
Previous wording
Cost of product revenues (excluding amortization of intangible assets) increased by $4.4 million, or 26.3%, to $21.0 million for the three months ended June 30, 2024 as compared to$16.6 million in the same period in 2023. The increase in cost of product revenues (excluding amortization of intangibles) for thethree months ended June 30, 2024 was primarily attributable to the increase in product revenues discussed above.
Current wording
Cost of product revenues (excluding amortization of intangible assets) increased by $4.5 million, or 26.7%, to $21.2 million for the three months ended September 30, 2024 as compared to$16.7 million in the same period in 2023. The increase in cost of product revenues (excluding amortization of intangibles) for thethree months ended September 30, 2024 was primarily attributable to the increase in product revenues discussed above.
Previous wording
SG&A expenses increased to $106.6 million during the three months ended June 30, 2024 from $84.4 million in the same period in 2023. The $22.1 million increase resulted primarily from an $9.7 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount and an$8.8 million increase in professional fees and other external expenses driven by commercial readiness activities for brensocatib.
Current wording
SG&A expenses increased to $118.9 million during the three months ended September 30, 2024 from $90.6 million in the same period in 2023. The $28.3 million increase resulted primarily from a $20.9 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount and a$3.9 million increase in professional fees and other external expenses driven by commercial readiness activities for brensocatib.
Previous wording
The change in fair value of deferred and contingent consideration for the three months ended June 30, 2024 was $103.7 million. The change is related to the fair value of the potential future consideration to be paid to former equityholders of the businesses we acquired. The change in fair value of deferred and contingent consideration for the three months ended June 30, 2024 was primarily due to the increase in our share price.
Current wording
The change in fair value of deferred and contingent consideration for the three months ended September 30, 2024 was $14.7 million. The change is related to the fair value of the potential future consideration to be paid to former equityholders of the businesses we acquired. The change in fair value of deferred and contingent consideration for the three months ended September 30, 2024 was primarily due to the increase in our share price.
Previous wording
Investment income decreased to $10.3 million for the three months ended June 30, 2024 as compared to $11.2 million in the same period in 2023 primarily due to a decrease in our average cash and cash equivalents and marketable securities balances in 2024 relative to 2023.
Current wording
Investment income increased to $17.0 million for the three months ended September 30, 2024 as compared to $10.6 million in the same period in 2023 primarily due to an increase in our average cash and cash equivalents and marketable securities balances in 2024 relative to 2023.
Previous wording
Interest expense increased to $21.3 million for the three months ended June 30, 2024 as compared to $20.6 million in the same period in 2023 primarily due to interest related to the Term Loan. See Note 10 - Debtand Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details.
Current wording
Interest expense increased to $21.1 million for the three months ended September 30, 2024 as compared to $20.3 million in the same period in 2023 primarily due to interest related to the Term Loan. See Note 10 - Debtand Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details.
Previous wording
The change in fair value of interest rate swap for the three months ended June 30, 2024 was $0.4 million. Adjustments to the fair value are due to changes in interest rates as of June 30, 2024 relative to the fair value of interest rate swap as of December 31, 2023.
Current wording
The change in fair value of interest rate swap for the three months ended September 30, 2024 was $3.9 million. Adjustments to the fair value are due to changes in interest rates as of September 30, 2024 relative to the fair value of interest rate swap as of December 31, 2023.
Previous wording
Our operating results for the six months ended June 30, 2024, included the following:
Current wording
Our operating results for the nine months ended September 30, 2024, included the following:
Previous wording
•Product revenues, net, increased$13.1 million, or 17.0%, as compared to the same period in the prior year as a result of the growth in ARIKAYCE sales;
Current wording
•Product revenues, net, increased$37.8 million, or 17.0%, as compared to the same period in the prior year as a result of the growth in ARIKAYCE sales;
Previous wording
•Cost of product revenues (excluding amortization of intangible assets) increased$8.0 million as compared to the same period in the prior year as a result of the increase in sales volumes of ARIKAYCE;
Current wording
•Cost of product revenues (excluding amortization of intangible assets) increased$12.5 million as compared to the same period in the prior year as a result of the increase in sales volumes of ARIKAYCE;
Previous wording
•R&D expenses decreased$57.0 million as compared to the same period in the prior year primarily as a result of the non-cash costs of the Adrestia and Vertuis acquisitions in 2023;
Current wording
•R&D expenses decreased$15.3 million as compared to the same period in the prior year primarily as a result of the non-cash costs of the Adrestia and Vertuis acquisitions in 2023;
Previous wording
•SG&A expenses increased $35.3 million as compared to the same period in the prior year primarily as a result of increases in compensation and benefit-related expensesand stock-based compensation costs;
Current wording
•SG&A expenses increased $63.6 million as compared to the same period in the prior year primarily as a result of increases in compensation and benefit-related expensesand stock-based compensation costs;
Previous wording
•Amortization of intangible assets of$2.5 million was consistent with the same period in the prior year;
Current wording
•Amortization of intangible assets of$3.8 million was consistent with the same period in the prior year;
Previous wording
•Change in fair value of deferred and contingent consideration liabilities increased $87.8 million, primarily as a result of the change in our share price; and
Current wording
•Change in fair value of deferred and contingent consideration liabilities increased $93.5 million, primarily as a result of the change in our share price;
Previous wording
Product revenues, net, consists of net sales of ARIKAYCE. The following table summarizes revenue by geography for the six months ended June 30, 2024 and 2023 (in thousands):
Current wording
Product revenues, net, consists of net sales of ARIKAYCE. The following table summarizes revenue by geography for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous wording
Product revenues, net, for the six months ended June 30, 2024 increased to $165.8 million as compared to $142.4 million in the same period in 2023, an increase of 16.4%, as a result of growth in ARIKAYCE sales in the US, Japan and Europe and the rest of the world.
Current wording
Product revenues, net, for the nine months ended September 30, 2024 increased to $259.3 million as compared to $221.5 million in the same period in 2023, an increase of 17.0%, as a result of growth in ARIKAYCE sales in the US, Japan and Europe and the rest of the world.
Previous wording
Cost of product revenues (excluding amortization of intangible assets) increased by $8.0 million, or 26.3%, to $38.4 million for the six months ended June 30, 2024 as compared to$30.4 million in the same period in 2023. The increase in cost of product revenues (excluding amortization of intangibles) for thesix months ended June 30, 2024 was primarily attributable to the increase in product revenues discussed above.
Current wording
Cost of product revenues (excluding amortization of intangible assets) increased by $12.5 million, or 26.4%, to $59.6 million for the nine months ended September 30, 2024 as compared to$47.1 million in the same period in 2023. The increase in cost of product revenues (excluding amortization of intangibles) for thenine months ended September 30, 2024 was primarily attributable to the increase in product revenues discussed above.
Previous wording
R&D expenses decreased to $267.8 million during the six months ended June 30, 2024 from $324.8 million in the same period in 2023. The$57.0 million decrease in R&D expenses was primarily due to the$86.7 million non-cash asset acquisition cost of Adrestia and Vertuis in the first half of 2023, partially offset by an increase of$24.7 million in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount and a $12.5 million milestone payment due to AstraZeneca upon our release of an official public statement that we intend to file an NDA for brensocatib.
Current wording
R&D expenses decreased to $418.6 million during the nine months ended September 30, 2024 from $434.0 million in the same period in 2023. The$15.3 million decrease in R&D expenses was primarily due to the$86.7 million non-cash asset acquisition cost of Adrestia and Vertuis in the first half of 2023, partially offset by an increase of$43.4 million in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, a $19.0 million increase in manufacturing expenses, and a $12.5 million milestone payment due to AstraZeneca upon our release of an official public statement that we intend to file an NDA for brensocatib.
Previous wording
External R&D expenses by product for the six months ended June 30, 2024 and 2023 were comprised of the following (in thousands):
Current wording
External R&D expenses by product for the nine months ended September 30, 2024 and 2023 were comprised of the following (in thousands):
Previous wording
SG&A expenses increased to $199.7 million during the six months ended June 30, 2024 from $164.3 million in the same period in 2023. The $35.3 million increase resulted primarily from an $16.5 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount and a$13.5 million increase in professional fees and other external expenses driven by commercial readiness activities for brensocatib.
Current wording
SG&A expenses increased to $318.6 million during the nine months ended September 30, 2024 from $255.0 million in the same period in 2023. The $63.6 million increase resulted primarily from a $37.4 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount and a$17.4 million increase in professional fees and other external expenses driven by commercial readiness activities for brensocatib.
Previous wording
Amortization of intangible assets for both the six months ended June 30, 2024 and 2023 was $2.5 million. Amortization of intangible assets is comprised of amortization of acquired ARIKAYCE R&D and amortization of the milestones paid to PARI for the FDA and EC approvals of ARIKAYCE.
Current wording
Amortization of intangible assets for both the nine months ended September 30, 2024 and 2023 was $3.8 million. Amortization of intangible assets is comprised of amortization of acquired ARIKAYCE R&D and amortization of the milestones paid to PARI for the FDA and EC approvals of ARIKAYCE.
Previous wording
The change in fair value of deferred and contingent consideration for the six months ended June 30, 2024 was $91.8 million. The change is related to the fair value of the potential future consideration to be paid to former equityholders of the businesses we acquired. The change in fair value of deferred and contingent consideration for the six months ended June 30, 2024 was primarily due to the increase in our share price.
Current wording
The change in fair value of deferred and contingent consideration for the nine months ended September 30, 2024 was $106.5 million. The change is related to the fair value of the potential future consideration to be paid to former equityholders of the businesses we acquired. The change in fair value of deferred and contingent consideration for the nine months ended September 30, 2024 was primarily due to the increase in our share price.
Previous wording
Investment income decreased to $19.1 million for the six months ended June 30, 2024 as compared to $21.7 million in the same period in 2023 primarily due to a decrease in our average cash and cash equivalents and marketable securities balances in 2024 relative to 2023.
Current wording
Investment income increased to $36.1 million for the nine months ended September 30, 2024 as compared to $32.3 million in the same period in 2023 primarily due to an increase in our average cash and cash equivalents and marketable securities balances in 2024 relative to 2023.
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Current report — wording carried from elsewhere
May 2019, we presented at the American Thoracic Society meeting that 41/65 (63.1%) of patients on ARIKAYCE plus GBT who had achieved culture conversion by Month 6 had maintained durable culture conversion for three months off all therapy compared to 0/10 (0%) on GBT only (p<0.0002). Safety data for these patients were consistent with safety data previously reported for patients by Month 6 of the CONVERT study.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
R&D expenses decreased to $146.7 million during the three months ended June 30, 2024 from $197.0 million in the same period in 2023. The $50.2 million decrease in R&D expenses was primarily due to the$76.5 million non-cash asset acquisition cost of Adrestia in the second quarter of 2023, partially offset by an increase of$14.0 million in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount and a $12.5 million milestone payment due to AstraZeneca upon our release of an official public statement that we intend to file an NDA for brensocatib.