INSM 8-K Current Reports

Leadership ChangesRegulation FDExhibits & Filings

Insmed 8-K Report, Financial Results (Oct 29, 2026)

Insmed Incorporated reported third-quarter 2026 financial results on October 29, 2026, with total company revenues of $524.4 million, up from $142.3 million in the third quarter of 2025. BRINSUPRI generated $400.1 million in revenue, which the company describes as 29% growth over the second quarter of 2026, driven by strong growth in the U.S. market. ARIKAYCE revenues were $124.4 million, reflecting 9% growth over the third quarter of 2025, primarily driven by international markets. The net loss narrowed to $100.3 million, or $0.46 per share, compared with a net loss of $370.0 million, or $1.75 per share, in the prior-year quarter. The company raised the low end of its full-year 2026 revenue guidance. BRINSUPRI guidance is now $1.35 billion to $1.4 billion, up from $1.25 billion to $1.4 billion, and ARIKAYCE guidance is $460 million to $470 million, up from $450 million to $470 million. Operating expenses rose year over year, with research and development expenses of $270.0 million and SG&A expenses of $253.0 million, reflecting BRINSUPRI commercialization and TPIP clinical development. As of September 30, 2026, cash, cash equivalents, and marketable securities totaled approximately $1.1 billion. Management stated it continues to believe cash flow positivity in 2027 can be achieved without additional capital, while expecting increased investment in clinical programs and Japan commercial infrastructure in the fourth quarter of 2026. Other developments include the FDA's acceptance of the ARIKAYCE sNDA for MAC lung disease with Priority Review and a PDUFA target action date of January 28, 2027, and the launch of BRINSUPRI Tablets 25 mg in Japan following MHLW approval in August 2026. The company also enrolled more than 35% of patients in the Phase 3 PALM-ILD study of TPIP.

Oct 29, 2026 8-K

Insmed 8-K Report, Executive Changes (Oct 20, 2026)

On October 16, 2026, Insmed Incorporated's Board of Directors appointed Paul Hudson and Utpal Koppikar as directors, effective October 19, 2026. Mr. Hudson, a Class II director, was named to the Compensation Committee, and Mr. Koppikar, a Class I director, was named to the Audit Committee. Both are subject to election at the 2027 Annual Meeting of Shareholders. The filing states that Mr. Hudson most recently served as CEO of Sanofi S.A. from September 2019 through February 2026 and previously as CEO of Novartis Pharmaceuticals from 2016 to 2019. Mr. Koppikar has served as CFO of Verily Health Inc. since April 2023 and previously as EVP and CFO of Atara Biotherapeutics from 2018 to 2023. Under the director compensation arrangements described in the filing, each new director receives an annual cash retainer of $65,000, prorated for 2026, and an RSU grant with a grant date fair value of approximately $585,000 that vests in equal parts over three years. Mr. Hudson receives an additional $12,500 annual retainer for Compensation Committee service, and Mr. Koppikar receives an additional $12,500 for Audit Committee service, both prorated. The company states that neither director was selected under any arrangement and that neither has a material interest in a related-person transaction under Item 404(a). The company also furnished a press release dated October 20, 2026 under Item 7.01 (Exhibit 99.1) announcing the appointments. In it, Will Lewis, Chair and CEO, said the new directors strengthen the Board's commercial, strategic, and financial capabilities. The filing does not report financial results or guidance.

Oct 20, 2026 8-K

Leadership ChangesRegulation FDExhibits & Filings

Insmed 8-K Report, Executive Changes (Oct 5, 2026)

Insmed Incorporated (Nasdaq: INSM) disclosed in an 8-K filed October 5, 2026 that Chief Financial Officer Sara Bonstein will step down effective October 30, 2026, after nearly seven years in the role. The filing states that the separation is not related to any disagreement with the Company on accounting practices, financial statements, internal controls, or operations. Ms. Bonstein will remain CFO through the reporting of third-quarter 2026 results and will participate in the earnings call on Thursday, October 29, 2026. The Company has commenced a search for a successor and has engaged a leading executive search firm. Ms. Bonstein will receive the benefits set forth in Section 6.e of her Amended and Restated Employment Agreement dated April 1, 2022. In the same press release, Insmed reaffirmed its full-year 2026 revenue guidance of $1.25 billion to $1.40 billion for BRINSUPRI (brensocatib) and $450 million to $470 million for ARIKAYCE (amikacin liposome inhalation suspension). Chair and CEO Will Lewis stated that the Company is well positioned to reach cash flow positivity next year and cited the company's raising of more than $4.2 billion in capital during Ms. Bonstein's tenure. Third-quarter 2026 financial results are scheduled for release on October 29, 2026, with a conference call beginning at 8:00 a.m. ET that day. For investors, the key items are the CFO transition timing, the continuity of the Q3 reporting process with the outgoing CFO still in place, and the reaffirmed 2026 product revenue guidance. The filing does not name a successor, and the press release is furnished under Item 7.01 rather than filed.

Oct 5, 2026 8-K

Insmed 8-K Report, Financial Results (Aug 6, 2026)

Insmed Incorporated reported second-quarter 2026 results on August 6, 2026, with total company revenues of $425.5 million, up from $107.4 million in the second quarter of 2025. BRINSUPRI generated $309.2 million in revenue in the quarter, with U.S. sales of $308.6 million, and the company states this reflects 49% growth over the first quarter of 2026. ARIKAYCE revenues were $116.3 million, up 8% from the prior-year quarter, driven primarily by international markets, which grew 19%. The company reported a net loss of $13.2 million, or $0.06 per share, compared with a net loss of $321.7 million, or $1.70 per share, in the second quarter of 2025. Operating loss narrowed to $1.5 million from $312.9 million, aided by a $99.8 million change in fair value of contingent consideration liabilities. Operating expenses rose, with SG&A at $247.5 million and R&D at $210.0 million, reflecting BRINSUPRI commercial investment and clinical development for TPIP. Cash, cash equivalents and marketable securities totaled approximately $1.2 billion as of June 30, 2026. Insmed raised its full-year 2026 BRINSUPRI revenue guidance to $1.25 billion to $1.40 billion from at least $1 billion, reiterated ARIKAYCE guidance of $450 million to $470 million, and raised its peak revenue estimate for its three lead programs to more than $14 billion. The company continues to expect cash flow positivity in 2027 without raising additional capital.

Aug 6, 2026 8-K

Insmed 8-K Report, Regulation FD Disclosure (Jul 16, 2026)

Insmed Incorporated (Nasdaq: INSM) reported 12-month safety and efficacy data from its ongoing open-label extension (OLE) study of treprostinil palmitil inhalation powder (TPIP), a once-daily inhaled investigational therapy in pulmonary arterial hypertension (PAH), in a press release and accompanying slide presentation filed under Item 7.01 on July 16, 2026. The study enrolled 91 patients, 60 in the TPIP Continued group and 31 in the Placebo Crossed group, and the company says both groups showed sustained or similar improvements at Month 12 in six-minute walk distance (6MWD), NT-proBNP, WHO Functional Class and REVEAL Lite 2.0 score. Mean 6MWD improvement from baseline was +55.7 meters for the TPIP Continued group and +54.1 meters for the Placebo Crossed group, and NT-proBNP was reduced by approximately 60% in both groups. On safety, the company reported that TPIP was generally well tolerated with no newly identified safety signals through Month 12 at doses up to 1,280 µg once daily. Treatment-emergent adverse events occurred in 89.0% of patients, serious TEAEs in 18.7%, and severe TEAEs in 16.5%, and TEAEs led to discontinuation in 7.7%. Four deaths occurred, none considered related to TPIP. The filing notes the study is single-arm and open-label for the TPIP Continued group, and that the efficacy endpoints are secondary and exploratory. The company stated that these data support continued development of TPIP and the recently initiated Phase 3 PALM-PAH trial, a randomized, double-blind, placebo-controlled study with 6MWD as its primary endpoint. Insmed plans to publish the 12-month OLE results in the future. The filing also states that TPIP is investigational and has not been approved for any indication in any jurisdiction.

Jul 16, 2026 8-K

Shareholder Matters

Insmed 8-K Report, Shareholder Vote Results (May 15, 2026)

Insmed Incorporated reported the results of its annual meeting of shareholders, held on May 13, 2026, in this Current Report on Form 8-K under Item 5.07 (Submission of Matters to a Vote of Security Holders). Shareholders voted on three proposals: the election of two Class II directors, an advisory vote on the 2025 compensation of named executive officers, and the ratification of Ernst & Young LLP as the independent registered public accounting firm for the year ending December 31, 2026. All three proposals were approved. Elizabeth McKee Anderson received 153,734,471 votes for and 32,130,980 withheld, and Clarissa Desjardins, Ph.D. received 164,437,828 votes for and 21,427,623 withheld, with both elected to serve until the 2029 Annual Meeting of Shareholders. On the advisory say-on-pay proposal, 162,133,728 shares voted for, 23,657,325 against, and 74,398 abstained. On the auditor ratification, 190,386,612 shares voted for, 6,997,613 against, and 45,308 abstained. Broker non-votes were 11,564,082 on the director election and say-on-pay proposals. The filing contains no new financial results, strategic announcements, or financial guidance. Its significance for investors is limited to governance: the shareholder support for the directors, the compensation program, and the auditor reflects the outcome of the meeting.

May 15, 2026 8-K

Insmed 8-K Report, Financial Results (May 7, 2026)

Insmed Incorporated reported first-quarter 2026 financial results on May 7, 2026, with total company revenues of $306.0 million, up from $92.8 million in the first quarter of 2025. BRINSUPRI (brensocatib) generated $207.9 million in revenue, which the company describes as 44% growth over the fourth quarter of 2025, and ARIKAYCE generated $98.1 million, reflecting 6% growth over the first quarter of 2025. The company reiterated full-year 2026 guidance of at least $1 billion for BRINSUPRI and $450 million to $470 million for ARIKAYCE. The company's net loss narrowed to $163.6 million, or $0.76 per share, from $256.6 million, or $1.42 per share, a year earlier. Operating expenses rose, with research and development at $209.5 million and selling, general and administrative expenses at $247.3 million, driven by the BRINSUPRI commercial launch and clinical development. Cost of product revenues was $47.4 million. As of March 31, 2026, cash, cash equivalents and marketable securities totaled approximately $1.2 billion. On the pipeline, the company reported positive topline results from the Phase 3b ENCORE study of ARIKAYCE in MAC lung disease, which met its primary and all multiplicity-controlled secondary culture conversion endpoints, and plans to submit an sNDA in the second half of 2026. It initiated the Phase 3 PALM-PAH study of TPIP in April 2026 and expects Phase 2b open-label extension data in the third quarter of 2026. The company also stated it expects cash flow positivity in 2027 without additional capital, per the accompanying slide presentation.

May 7, 2026 8-K

Insmed 8-K Report, Regulation FD Disclosure (Apr 7, 2026)

Insmed Incorporated (Nasdaq: INSM) announced on April 7, 2026 topline results from its Phase 2b CEDAR study of brensocatib in adults with moderate to severe hidradenitis suppurativa (HS). The study did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg arms. The primary endpoint was percent change from baseline in total abscess and inflammatory nodule (AN) count at Week 16. At Week 16, AN count fell 45.5% in the 10 mg arm and 40.3% in the 40 mg arm, versus a 57.1% reduction in the placebo arm. The company reported that brensocatib was well tolerated, with no new safety signals identified, including in the 40 mg arm, which is the highest dose Insmed has studied to date. Treatment-emergent adverse event rates were 55.4% (41 of 74) in the 10 mg arm, 42.9% (30 of 70) in the 40 mg arm, and 45.7% (32 of 70) in the placebo arm. One severe TEAE occurred in the 10 mg arm, and serious TEAEs were reported in 4.1% (3 of 74) of the 10 mg arm, 1.4% (1 of 70) of the 40 mg arm, and 1.4% (1 of 70) of the placebo arm. Insmed will discontinue its development program of brensocatib in HS and intends to present the data at a future congress. The company framed the CEDAR study as a proof-of-concept study, noting that the lack of established animal models makes HS development particularly challenging.

Apr 7, 2026 8-K

Earnings & ResultsLeadership ChangesExhibits & Filings

Insmed 8-K Report, Regulation FD Disclosure (Mar 23, 2026)

Insmed Incorporated (Nasdaq: INSM) announced positive topline results from its Phase 3b ENCORE study of ARIKAYCE (amikacin liposome inhalation suspension) plus multidrug therapy (azithromycin 250 mg + ethambutol 15 mg/kg) once daily versus placebo plus multidrug therapy in diagnosed patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics. The study randomized 425 patients 1:1 (213 ARIKAYCE, 212 placebo) across 177 sites globally. The primary endpoint, change from baseline in Respiratory Symptom Score at Month 13, was 17.77 points for ARIKAYCE versus 14.66 points for placebo, a treatment difference of 3.11 points (p=0.0299, statistically significant). All multiplicity-controlled secondary culture conversion endpoints were statistically significant (p<0.0001), including culture conversion by Month 6 (87.8% vs. 57.0%) and durable culture conversion at Month 15 (76.2% vs. 47.6%). The PROMIS Fatigue T-score change at Month 13 was not statistically significant (p=0.2900). The company states it has completed the study intended to fulfill the FDA post-marketing requirement. Insmed plans to file a supplemental new drug application (sNDA) for ARIKAYCE in MAC lung disease in the second half of 2026 to seek label expansion and traditional approval for the existing refractory indication in the U.S., and to submit data to Japan's PMDA in the same period. The safety profile was described as consistent with the known profile, with no new safety signals. Dysphonia (58.7% vs. 8.5%), cough, and dyspnea were more frequent on ARIKAYCE, and bronchospasm (23.0% vs. 11.8%) and hypersensitivity pneumonitis (2.3% vs. 0%) occurred in notably more ARIKAYCE patients. No deaths were considered related to study drug, and the treatment discontinuation rate was 18.3% on ARIKAYCE versus 11.8% on comparator. The company also furnished a press release (Exhibit 99.1) and a slide presentation (Exhibit 99.2) and hosted a conference call on March 23, 2026 at 8:00 a.m. ET. The filing notes that additional data will be presented at future medical meetings.

Mar 23, 2026 8-K

Insmed 8-K Report, Financial Results (Feb 19, 2026)

Insmed Incorporated (Nasdaq: INSM) reported fourth-quarter and full-year 2025 results on February 19, 2026, alongside a business update. Full-year 2025 total company revenues were $606.4 million, with BRINSUPRI contributing $172.7 million (following its U.S. commercial launch in August 2025) and ARIKAYCE contributing $433.8 million, which the company states represents 19% annual growth and exceeds the upper end of its 2025 guidance. Fourth-quarter 2025 total revenues were $263.8 million, of which BRINSUPRI contributed $144.6 million. The company reported a full-year 2025 net loss of $1,276.8 million, or $6.42 per share, versus a net loss of $913.8 million, or $5.57 per share, in 2024. Cash, cash equivalents, and marketable securities were approximately $1.4 billion at December 31, 2025. Looking ahead, Insmed anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion and reiterates full-year 2026 ARIKAYCE revenue guidance of $450 million to $470 million. The company states that it is confident cash flow positivity can be achieved without raising capital, though it may raise capital to support business development or other value-creating initiatives. Key pipeline catalysts flagged for 2026 include the Phase 3 ENCORE topline readout for ARIKAYCE expected in March or April, the Phase 2b CEDAR topline data for brensocatib in hidradenitis suppurativa expected in the second quarter, and plans to start a Phase 3 TPIP study in PAH in the first half of 2026. Separately, director David W.J. McGirr notified the board on February 17, 2026 that he will not stand for re-election at the 2026 Annual Meeting; he will remain on the board and as Audit Committee chair until then, and the company states his decision was not due to any disagreement with the company.

Feb 19, 2026 8-K

Insmed 8-K Report, Regulation FD Disclosure (Jan 9, 2026)

Insmed Incorporated (Nasdaq: INSM) furnished an 8-K on January 9, 2026 under Item 7.01 (Regulation FD) containing a press release and slide presentation for its appearance at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026. The company reported preliminary, unaudited full-year 2025 total revenues of approximately $606.4 million (U.S. $453.0 million, international $153.5 million), up from $363.7 million in 2024. ARIKAYCE generated approximately $433.8 million globally in 2025, exceeding the upper end of its guidance range, while BRINSUPRI, launched in the U.S., generated approximately $172.7 million for full-year 2025, including approximately $144.6 million in the fourth quarter, its first full quarter of launch. Final fourth-quarter and full-year 2025 results are to be reported in February 2026, and the company cautioned the preliminary figures could differ materially. Looking ahead, Insmed guided 2026 global ARIKAYCE revenues to between $450 million and $470 million. Key anticipated catalysts include topline data from the Phase 3 ENCORE study of ARIKAYCE in March or April 2026, with a planned supplemental NDA in the second half of 2026 if results are positive; topline data from the Phase 2b CEDAR study of brensocatib in hidradenitis suppurativa in the second quarter of 2026; and the initiation of additional Phase 3 TPIP studies in PAH, PPF, and IPF. The company also noted that BRINSUPRI's results do not yet reflect final contracting and access dynamics, with management expecting out-of-pocket reset effects in the first quarter of 2026 and rebating to increase as payor contracts are finalized.

Jan 9, 2026 8-K

Insmed 8-K Report, Regulation FD Disclosure (Dec 17, 2025)

Insmed Incorporated (Nasdaq: INSM) reported on December 17, 2025 that the Phase 2b BiRCh study of brensocatib in chronic rhinosinusitis without nasal polyps (CRSsNP) did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg arms. The primary endpoint was change from baseline in the 28-day average of daily Sinus Total Symptom Score at Week 24. Placebo's least squares mean was -2.44, versus -2.21 for the 10 mg arm and -2.33 for the 40 mg arm, where a negative score indicates improvement. The company said brensocatib was well tolerated with no new safety signals, including at 40 mg, the highest dose studied to date. Insmed has discontinued the brensocatib CRSsNP development program effective immediately and intends to present the data at a future congress. In the same announcement, Insmed disclosed its acquisition of INS1148, an investigational monoclonal antibody that it describes as potentially first-in-class and as preferentially targeting a specific isoform of Stem Cell Factor. The company plans to advance INS1148 into Phase 2 development, initially in interstitial lung disease and moderate-to-severe asthma. The filing states that INS1148 was developed by Opsidio, a private, clinical-stage company, and was formerly known as OpSCF. The filing does not disclose the acquisition consideration. For investors, the key takeaways are the failed CRSsNP readout, which removes that indication from the pipeline, and the pivot toward a new clinical-stage asset in respiratory and immunological and inflammatory diseases. The filing's forward-looking statements flag the risk that full BiRCh data may differ from topline results and the risk that the company may be unable to integrate and develop INS1148.

Dec 17, 2025 8-K

Insmed 8-K Report, Regulation FD Disclosure (Nov 18, 2025)

On November 18, 2025, Insmed Incorporated (Nasdaq: INSM) filed a Form 8-K under Items 7.01 (Regulation FD Disclosure) and 8.01 (Other Events) to report that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. The approval follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use on October 16, 2025, and the drug was reviewed under the EMA's accelerated assessment pathway. The company says it will engage with EU authorities to secure access for eligible patients beginning in early 2026. Brensocatib is also under review with the UK's MHRA and Japan's PMDA. The press release (Exhibit 99.1) describes the Phase 3 ASPEN study, in which patients taking BRINSUPRI 25 mg had a 19.4% reduction in annual rate of exacerbations versus placebo, along with statistically significant less decline in FEV1 at week 52. The most frequently reported adverse reactions were headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rash (4.1%), upper respiratory tract infections (3.9%), and dry skin (3.0%). The company states the EU approval is the first and only approved treatment for NCFB in the EU. For investors, the filing is a regulatory milestone that expands BRINSUPRI's approved geography beyond the United States. The filing does not provide sales guidance or commercial financial figures. The release notes that the EU indication is narrower than the U.S. indication, which covers adult and pediatric patients 12 years and older without the two-exacerbation requirement.

Nov 18, 2025 8-K

Insmed 8-K Report, Financial Results (Oct 30, 2025)

Insmed Incorporated (Nasdaq: INSM) reported third-quarter 2025 financial results on October 30, 2025, highlighting the first full-quarter contribution from BRINSUPRI (brensocatib), approved by the FDA in August 2025 for non-cystic fibrosis bronchiectasis. Total revenues were $142.3 million for the quarter, versus $93.4 million a year earlier, comprising $114.3 million of ARIKAYCE revenue (up 22% year over year) and $28.1 million of BRINSUPRI U.S. revenue. The company reported a net loss of $370.0 million, or $1.75 per share, compared with a net loss of $220.5 million, or $1.27 per share, in the prior-year quarter. Operating expenses rose sharply, with R&D at $186.4 million and SG&A at $186.4 million, both driven by BRINSUPRI commercial readiness and clinical development. The company raised its full-year 2025 global ARIKAYCE revenue guidance to $420 million to $430 million, up from $405 million to $425 million. Cash, cash equivalents and marketable securities totaled approximately $1.7 billion as of September 30, 2025. Management stated that the BRINSUPRI results are promising but do not yet represent final contracting and access dynamics, and that inventory stocking accounted for roughly 40% of third-quarter sales. Near-term catalysts include topline data from the Phase 2b BiRCh study of brensocatib in chronic rhinosinusitis without nasal polyps by early January 2026, topline data from the Phase 2b CEDAR study in hidradenitis suppurativa in the first half of 2026, and the Phase 3 ENCORE readout for ARIKAYCE in the first half of 2026. The company also expects a Phase 3 PALM-ILD study of TPIP to begin in the fourth quarter of 2025.

Oct 30, 2025 8-K

Insmed 8-K Report, Regulation FD Disclosure (Aug 12, 2025)

Insmed Incorporated (Nasdaq: INSM) announced on August 12, 2025 that the U.S. Food and Drug Administration has approved BRINSUPRI (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. The company describes it as the first and only FDA-approved treatment for NCFB and a first-in-class DPP1 inhibitor. The filing states that BRINSUPRI is now available by prescription through a specialty pharmacy network, and the company's presentation projects peak sales above $5 billion in the NCFB indication only, with a gross-to-net assumption of approximately 25% to 35%. The approval rests on the Phase 3 ASPEN and Phase 2 WILLOW studies, both published in the New England Journal of Medicine. In ASPEN, patients taking BRINSUPRI 10 mg or 25 mg had a 21.1% and 19.4% reduction in annual rate of exacerbations, respectively, versus placebo. The 25 mg dose also showed statistically significant less decline in FEV1 at week 52. Safety highlights in the label include dermatologic adverse reactions, gingival and periodontal adverse reactions, and a warning to avoid live attenuated vaccines. The company also noted that applications are under review with the EMA and MHRA, that it plans to file in Japan in 2025, and that commercial launches outside the U.S. are anticipated in 2026, pending approval. The company will host a conference call on August 12, 2025 at 12:00 p.m. Eastern Time to discuss the approval. The presentation states that the company expects its sales force to begin engaging U.S. pulmonologists immediately, and it cites approximately 500,000 U.S. patients diagnosed with NCFB as the potential addressable population.

Aug 12, 2025 8-K

Insmed 8-K Report, Financial Results (Aug 7, 2025)

Insmed Incorporated (Nasdaq: INSM) reported second-quarter 2025 results on August 7, 2025, with total ARIKAYCE revenue of $107.4 million, up 18.9% from $90.3 million in the second quarter of 2024. Growth was seen across all regions, with U.S. revenue at $68.7 million (up 7.7%), Japan at $30.7 million (up 45.3%), and Europe & Rest of World at $8.1 million (up 48.3%). The company reported a net loss of $321.7 million, or $1.70 per share, compared with a net loss of $300.6 million, or $1.94 per share, a year earlier. Operating expenses rose, with R&D at $177.2 million and SG&A at $154.8 million, the latter driven by headcount growth and commercial readiness activities for brensocatib. The key near-term catalyst is the PDUFA target action date of August 12, 2025, for brensocatib in bronchiectasis, with Insmed stating it expects an immediate U.S. launch if approved. The company also reiterated its 2025 global ARIKAYCE revenue guidance of $405 million to $425 million. On the pipeline, Insmed reported positive Phase 2b topline data for TPIP in PAH in June 2025, with a Phase 3 study in PH-ILD planned for the second half of 2025 and in PAH for early 2026. Topline data from the Phase 2b BiRCh study of brensocatib in CRSsNP is expected by the end of 2025. As of June 30, 2025, cash, cash equivalents, and marketable securities totaled approximately $1.9 billion, following an June 2025 equity offering with estimated net proceeds of $823.1 million. The company also redeemed its remaining $569.5 million of 0.75% convertible notes due 2028 in April 2025. Shareholders' equity rose to $1.25 billion at June 30, 2025, from $285.4 million at December 31, 2024.

Aug 7, 2025 8-K

Insmed 8-K Report, Regulation FD Disclosure (Jun 13, 2025)

Insmed Incorporated (Nasdaq: INSM) filed this Form 8-K on June 13, 2025 to disclose an underwritten public offering of its common stock. On June 11, 2025, the Company entered into an Underwriting Agreement with Goldman Sachs & Co. LLC and Leerink Partners LLC, as representatives of the underwriters, to sell 7,812,500 firm shares of common stock at $91.68 per share after underwriting discounts and commissions, with net proceeds to the Company of approximately $716.3 million before other offering expenses. The underwriters also received a 30-day option to purchase up to an additional 1,171,875 shares. The offering is being made under an automatically effective Form S-3 shelf registration statement (No. 333-272088), and closing is expected on June 13, 2025, subject to customary conditions. The press release announcing the pricing states the offering price to the public is $96.00 per share, with gross proceeds of approximately $750 million before underwriting discounts and other expenses. The Company intends to use the net proceeds to fund continued research and development of brensocatib, pre-commercial and, if approved, commercialization activities for brensocatib, activities related to the further commercialization and development of ARIKAYCE, research and development of treprostinil palmitil inhalation powder (TPIP) and INS1201, pre-clinical research, and general corporate purposes, including business expansion activities. The filing also includes the launch press release, which described an initially proposed offering of $650 million with a $97.5 million underwriter option, and a legal opinion from Hunton Andrews Kurth LLP regarding the shares. The forward-looking statements in the press releases flag risks including market conditions, regulatory approvals for brensocatib and TPIP, ARIKAYCE commercialization, covenant compliance under its Pharmakon senior secured loan and OrbiMed royalty financing, and the Company's history of operating losses.

Jun 13, 2025 8-K

Insmed 8-K Report, Regulation FD Disclosure (Jun 10, 2025)

Insmed Incorporated (INSM) announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b study of treprostinil palmitil inhalation powder (TPIP), a once-daily therapy, in patients with pulmonary arterial hypertension (PAH). The study met its primary endpoint and all secondary efficacy endpoints. The placebo-adjusted reduction from baseline in pulmonary vascular resistance was 35% (LS mean ratio 0.65; 95% CI: 0.54, 0.79; p<0.001), the placebo-adjusted improvement in six-minute walk distance was 35.5 meters (95% CI: 11.2, 60.7; p=0.003), and the placebo-adjusted reduction in NT-proBNP was 60% (LS mean ratio 0.40; 95% CI: 0.27, 0.59; p<0.001). Efficacy was measured approximately 24 hours after dosing. The study enrolled 102 patients across 44 sites, randomized 2:1 to TPIP (n=69) or placebo (n=33) for 16 weeks. TPIP was generally well tolerated: treatment-emergent adverse events occurred in 88.4% of TPIP patients versus 75.8% on placebo, and treatment discontinuation due to adverse events was 5.8% on TPIP versus none on placebo. The most common adverse event was cough (40.6% vs. 21.2%). There were no deaths in the study. Based on these results, Insmed will engage with the U.S. Food and Drug Administration regarding the Phase 3 trial design for PAH. The company plans to start a Phase 3 trial in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) before the end of 2025 and a Phase 3 trial in PAH in early 2026. Detailed results will be presented at future medical meetings.

Jun 10, 2025 8-K

Leadership ChangesShareholder Matters

Insmed 8-K Report, Corporate Update (Jun 6, 2025)

Insmed Incorporated (INSM) reported in this Form 8-K, filed under Item 8.01 (Other Events), that on June 6, 2025 (the "Redemption Date") it completed its previously announced redemption of all outstanding 0.75% Convertible Senior Notes due 2028 (the "Notes"). Notes with an aggregate principal amount of $1,965,204.69 that had not already been converted by holders were redeemed for cash at 100% of principal amount, plus accrued and unpaid interest to, but excluding, the Redemption Date. The redemption was carried out under the Indenture dated January 26, 2018, as supplemented by the Second Supplemental Indenture dated May 13, 2021, between the Company and Computershare Trust Company, N.A., as successor trustee to Wells Fargo Bank, National Association. The filing is a notice of completed debt retirement. It does not report operating results, guidance, or other financial performance metrics.

Jun 6, 2025 8-K

Insmed 8-K Report, Executive Changes (May 16, 2025)

At its annual meeting of shareholders held on May 15, 2025, Insmed Incorporated's shareholders approved Amendment No. 2 to the Amended and Restated 2019 Incentive Plan, which had previously been adopted by the Board of Directors. A summary of the plan's material terms appears in the company's definitive proxy statement filed April 4, 2025, under Proposal No. 4, and is incorporated into this filing by reference. The filing also reports on the other matters voted on at the meeting, as detailed below. Of the 181,820,010 shares entitled to vote as of the March 7, 2025 record date, 166,336,150 shares were present in person or by proxy. Shareholders elected Leo Lee and William H. Lewis as Class I directors to serve until the 2028 Annual Meeting. They approved, on an advisory basis, the 2024 compensation of the named executive officers, with 142,263,777 votes for and 4,990,969 against. They also ratified Ernst & Young LLP as the independent registered public accounting firm for the year ending December 31, 2025, with 160,950,440 votes for and 5,335,836 against. For investors, the principal governance action is the approval of the 2019 Incentive Plan amendment, which received 137,896,887 votes for and 9,337,276 against. The filing does not describe the specific terms of the amendment beyond what is in the incorporated proxy statement summary.

May 16, 2025 8-K

Other EventsExhibits & Filings

Insmed 8-K Report, Financial Results (May 8, 2025)

Insmed Incorporated reported first-quarter 2025 financial results on May 8, 2025. Total ARIKAYCE revenue was $92.8 million, up 22.9% from $75.5 million in the first quarter of 2024, with U.S. revenue of $64.3 million (up 14.1%), Japan revenue of $22.1 million (up 48.3%), and Europe & Rest of World revenue of $6.5 million (up 51.8%). The company reiterated its full-year 2025 global ARIKAYCE revenue guidance of $405 million to $425 million. Net loss widened to $256.6 million, or $1.42 per share, compared with a net loss of $157.1 million, or $1.06 per share, a year earlier. Research and development expenses were $152.6 million and selling, general and administrative expenses were $147.5 million, both up from the prior-year quarter, reflecting headcount growth and preparation for a potential brensocatib launch. The company's pipeline milestones remain central to the investment case. The FDA accepted the New Drug Application for brensocatib in bronchiectasis with Priority Review and a PDUFA target action date of August 12, 2025. The Phase 2b study of TPIP in pulmonary arterial hypertension has completed, with topline data expected in June 2025. Enrollment is complete in the Phase 2b BiRCh study of brensocatib in chronic rhinosinusitis without nasal polyps, with topline results expected by the end of 2025. The company also announced a notice of redemption for all $569.5 million of its remaining 0.75% Convertible Senior Notes due 2028, with a redemption date of June 6, 2025. As of March 31, 2025, Insmed reported cash, cash equivalents, and marketable securities of approximately $1.2 billion, compared with total liabilities of $1.70 billion and total shareholders' equity of $99.2 million on the balance sheet. The filing states the company plans to continue investing in ARIKAYCE commercialization, brensocatib launch preparation, clinical programs, and TPIP development.

May 8, 2025 8-K

Insmed 8-K Report, Corporate Update (Apr 24, 2025)

Insmed Incorporated (Nasdaq: INSM) announced on April 24, 2025 that it has called all $569.5 million aggregate principal amount of its remaining outstanding 0.75% Convertible Senior Notes due 2028 for redemption. All outstanding Notes will be redeemed on June 6, 2025 at a redemption price equal to 100% of principal plus accrued and unpaid interest to, but excluding, the Redemption Date. The press release states that for each $1,000 principal amount of Notes, the redemption price will be approximately $1,000.10, payable in cash. Holders may still convert their Notes until 5:00 p.m. New York City time on June 4, 2025, or later if the Company fails to pay the Redemption Price on the Redemption Date. The Company has elected to settle conversions in shares of common stock. The conversion rate is 30.7692 shares per $1,000 principal amount, equivalent to a conversion price of approximately $32.50 per share, and up to 17,523,336 shares would be issued if all Notes are converted. The filing is a Form 8-K under Item 8.01 (Other Events), with the redemption announcement furnished as Exhibit 99.1. The filing states that it is not itself a notice of redemption or convertibility, and that the redemption is made solely pursuant to the Notice of Redemption dated April 24, 2025.

Apr 24, 2025 8-K/A

Insmed 8-K/A Report, Corporate Update (Apr 24, 2025)

Insmed Incorporated (INSM) filed this Form 8-K/A amendment to correct its original Current Report filed April 24, 2025. The amendment revises Exhibit 99.1 of the Original Form 8-K solely to reflect an increased conversion rate under the make-whole provisions of the indenture governing its 0.75% Convertible Senior Notes due 2028. The increase resulted from the company's delivery of a notice of redemption before the Notes' maturity date. As of April 24, 2025, the conversion rate is 31.2861 shares of common stock per $1,000 principal amount of Notes, equivalent to a conversion price of approximately $31.96 per share. If all of the Notes are converted, up to 17,817,715 shares of common stock would be issued. Investors should note the potential dilution this share count represents. The filing states that, other than the corrected conversion rate and related share figures in the Explanatory Note, the amendment does not change any other disclosures in the Original Form 8-K.

Apr 24, 2025 8-K

Leadership Changes

Insmed 8-K Report, Executive Changes (Apr 17, 2025)

Insmed Incorporated (INSM) filed a Form 8-K under Item 5.02 reporting that J. Drayton Wise resigned as the Company's Chief Commercial Officer, effective immediately, as notified on April 16, 2025. The filing states that his resignation was for personal and medical reasons and was not related to the Company's financial or operating results or to any disagreements with the Company regarding its operations, policies, or practices. In connection with the departure, Mr. Wise entered into a consulting agreement with the Company dated April 16, 2025. He will be reasonably available to provide consulting services through December 31, 2025, with automatic extension for two three-month periods unless terminated by mutual agreement. His consulting fee is $30,000 per month during the initial period and $20,000 per month during any extension period, conditioned on his compliance with the agreement. Mr. Wise's outstanding equity awards will continue to vest during the consulting period. His stock options will remain exercisable, to the extent vested, until the earlier of three months after the last day of his service relationship with the Company and the original 10-year expiration date.

Apr 17, 2025 8-K

Earnings & ResultsLeadership ChangesExhibits & Filings

Insmed 8-K Report, Regulation FD Disclosure (Feb 24, 2025)

Insmed Incorporated (Nasdaq: INSM) disclosed on February 24, 2025 that the U.S. Food and Drug Administration does not currently plan to hold an advisory committee meeting to discuss the company's New Drug Application for brensocatib in patients with non-cystic fibrosis bronchiectasis. The company reported that the FDA communicated this in its Day 74 letter to Insmed. The FDA had previously granted Priority Review to the application and set a Prescription Drug User Fee Act target action date of August 12, 2025. The filing states that the company is committed to working closely with the agency to complete the review. The company describes brensocatib, an oral, reversible inhibitor of dipeptidyl peptidase 1, as having the potential to become the first and only approved treatment for bronchiectasis and the first in a new class of DPP1 inhibitors. The application is based on data from the ASPEN study, which the company describes as the largest Phase 3 study ever conducted in patients with bronchiectasis. The disclosure was made under Items 8.01 and 7.01 of Form 8-K, with the press release furnished as Exhibit 99.1. The filing states that brensocatib has not been approved for any indication in any jurisdiction.

Feb 24, 2025 8-K

Insmed 8-K Report, Financial Results (Feb 20, 2025)

Insmed Incorporated reported fourth-quarter and full-year 2024 financial results on February 20, 2025, per a press release furnished as Exhibit 99.1. Total ARIKAYCE revenue was $104.4 million for the fourth quarter and $363.7 million for the full year 2024, a 19.2% increase over 2023, exceeding the upper end of full-year 2024 guidance. The company reiterated full-year 2025 global ARIKAYCE revenue guidance of $405 million to $425 million. Net loss was $235.5 million ($1.32 per share) for the fourth quarter and $913.8 million ($5.57 per share) for the full year 2024. Cash, cash equivalents, and marketable securities totaled approximately $1.4 billion at December 31, 2024. The most significant pipeline development is the FDA's acceptance of the brensocatib New Drug Application for bronchiectasis with Priority Review and a PDUFA target action date of August 12, 2025. The company expects a U.S. launch in the third quarter of 2025 if approved. Topline data timing was reiterated for TPIP in PAH (mid-2025), brensocatib in CRSsNP (end of 2025), and ENCORE for ARIKAYCE (first quarter of 2026). The company also plans a Phase 3 study of TPIP in PH-ILD in the second half of 2025 and initiation of a clinical study of gene therapy INS1201 in the first half of 2025. In a separate Item 5.02 disclosure, director Alfred Altomari notified the Board on February 18, 2025 that he will not stand for re-election at the 2025 Annual Meeting of Shareholders. He will continue serving on the Board and its Audit and Compensation Committees until then, and the filing states his decision was not due to any disagreement with the company.

Feb 20, 2025 8-K

Insmed 8-K Report, Regulation FD Disclosure (Feb 6, 2025)

Insmed Incorporated (Nasdaq: INSM) announced on February 6, 2025 that the U.S. Food and Drug Administration has accepted for review its New Drug Application for brensocatib for patients with non-cystic fibrosis bronchiectasis. The FDA granted Priority Review and set a Prescription Drug User Fee Act target action date of August 12, 2025. The company said the FDA has not indicated whether an advisory committee will be convened. The application is based on the Phase 3 ASPEN study, in which both dosage strengths of brensocatib (10 mg and 25 mg) met the primary endpoint of reducing the annualized rate of pulmonary exacerbations versus placebo over 52 weeks. Both doses also met several prespecified exacerbation-related secondary endpoints, and the 25 mg dose showed significantly lower lung function decline at week 52 as measured by post-bronchodilator FEV1. Treatment-emergent adverse events occurring in at least 5.0% of patients more frequently than placebo included COVID-19, nasopharyngitis, cough, and headache. The FDA had previously granted brensocatib Breakthrough Therapy Designation. Insmed plans to file regulatory submissions for brensocatib in the EU, UK, and Japan in 2025, with commercial launches anticipated in 2026, pending approval in each territory. The filing describes brensocatib as an investigational drug that has not been approved for any indication in any jurisdiction.

Feb 6, 2025 8-K

Earnings & ResultsMaterial AgreementsFinancial Events+1

Insmed 8-K Report, Regulation FD Disclosure (Jan 10, 2025)

Insmed Incorporated (Nasdaq: INSM) filed this Form 8-K under Item 7.01 (Regulation FD Disclosure) to furnish materials for a presentation by Chair and CEO Will Lewis at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025. The company issued a press release on January 10, 2025 (Exhibit 99.1) and attached a slide presentation (Exhibit 99.2). The company reports preliminary, unaudited full-year 2024 global ARIKAYCE net product sales of approximately $363.7 million, up 19% year over year, with the United States at $254.8 million (up 14%), Japan at $87.7 million (up 33%), and Europe at $21.2 million (up 39%). It guides 2025 global ARIKAYCE revenues to between $405 million and $425 million, which it describes as 11% to 17% growth over 2024. Final fourth-quarter and full-year 2024 results are to be reported in late February 2025. The filing's main pipeline update concerns brensocatib. The company submitted a New Drug Application for brensocatib in bronchiectasis to the FDA in December 2024 and is awaiting FDA acceptance. If priority review is granted and the drug is approved, the company anticipates a U.S. launch in the third quarter of 2025. The Phase 3 ENCORE trial of ARIKAYCE in newly diagnosed or recurrent MAC lung disease is fully enrolled with 425 patients, and topline data are anticipated in the first quarter of 2026. Enrollment in the Phase 2 PAH study of TPIP is complete with 102 patients randomized, and topline data are now expected in mid-2025. The FDA cleared the IND for INS1201, the company's lead gene therapy for Duchenne muscular dystrophy, in December 2024, with first patient dosing anticipated in the first half of 2025. The filing states that the company's cash, cash equivalents, and marketable securities were preliminarily unaudited above $1.4 billion as of December 31, 2024. Investors should note that the filing carries the ARIKAYCE boxed warning for increased respiratory adverse reactions, and that the company's forward-looking statements cite risks including commercialization, regulatory approval timing, reimbursement, and covenants under its senior secured loan and royalty financing.

Jan 10, 2025 8-K

Material Agreements

Insmed 8-K Report, Agreement Terminated (Nov 19, 2024)

Insmed Incorporated disclosed in this Form 8-K, under Item 1.02 (Termination of a Material Definitive Agreement), that it terminated its at-the-market Sales Agreement with Leerink Partners LLC, as agent, on November 18, 2024. The termination was effective immediately. The agreement had been entered into on February 22, 2024, and allowed the company to offer and sell shares of its common stock, par value $0.01 per share, with an aggregate offering price of up to $500,000,000 through Leerink. The filing states that no shares had been issued or sold under the agreement since September 30, 2024. The company also states it is not subject to any termination penalties related to ending the agreement. For investors, the filing indicates that the company no longer has access to this specific equity sales facility, and that the $500,000,000 capacity under it is no longer available. The full text of the agreement was filed previously as Exhibit 10.1 to the company's Current Report on Form 8-K filed February 22, 2024, and this filing refers to that exhibit for the complete terms.

Nov 19, 2024 8-K

Insmed 8-K Report, Material Agreement (Oct 31, 2024)

Insmed Incorporated (Nasdaq: INSM) filed an 8-K on October 31, 2024 reporting two financing actions and its third-quarter 2024 results. On October 31, 2024, the company entered into an Amended and Restated Loan Agreement with BioPharma Credit PLC as Collateral Agent and funds managed by Pharmakon Advisors, LP. The agreement adds a new $150 million senior secured Tranche B Term Loan, continues the $350 million Tranche A Term Loan (plus $46,769,917 of accrued and capitalized paid-in-kind interest), carries a fixed rate of 9.60% per annum, and extends maturity to September 30, 2029, subject to acceleration to February 1, 2028 on certain prespecified events. The company also signed a First Amendment to its Revenue Interest Purchase Agreement with OrbiMed Royalty & Credit Opportunities IV, LP, which amends restrictions on incurring indebtedness. For the third quarter of 2024, total revenue was $93.4 million, up 18% year over year from $79.1 million, with ARIKAYCE net sales of $66.9 million in the U.S., $21.0 million in Japan, and $5.6 million in Europe and rest of world. Net loss widened to $220.5 million, or $1.27 per share, from $158.9 million, or $1.11 per share, in the prior-year quarter. R&D expense rose to $150.8 million and SG&A to $118.9 million, reflecting manufacturing, compensation, and launch-readiness spending for brensocatib. Cash, cash equivalents, and marketable securities totaled $1,467.9 million at September 30, 2024. The company reiterated full-year 2024 global ARIKAYCE revenue guidance of $340 million to $360 million and said it remains on track to submit the brensocatib NDA for bronchiectasis in the fourth quarter of 2024, with a potential U.S. launch in mid-2025 if priority review is granted.

Oct 31, 2024 8-K

Insmed 8-K Report, Corporate Update (Aug 9, 2024)

Insmed Incorporated (INSM) filed this Current Report on Form 8-K to report that on August 9, 2024 (the "Redemption Date"), it completed the previously announced redemption of all outstanding aggregate principal of its 1.75% Convertible Senior Notes due 2025 (the "Notes"). Notes with an aggregate principal amount of $198,000 that had not already been converted by holders were redeemed for cash. The Notes were redeemed at 100% of their principal amount, plus accrued and unpaid interest up to, but excluding, the Redemption Date. The redemption was carried out under the Indenture dated January 26, 2018, as supplemented by the First Supplemental Indenture of the same date, between the Company and Computershare Trust Company, National Association, as successor trustee to Wells Fargo Bank, National Association. For investors, this is a routine debt-settlement event. The filing reports only the small residual principal that remained after prior conversions, and it contains no new financial results, guidance, or changes to operations.

Aug 9, 2024 8-K

Insmed 8-K Report, Financial Results (Aug 8, 2024)

Insmed Incorporated reported financial results for the second quarter ended June 30, 2024, in a press release furnished as Exhibit 99.1 to this Item 2.02 Form 8-K. Total revenue was $90.3 million, up 17% from $77.2 million in the second quarter of 2023, driven by ARIKAYCE net sales of $63.8 million in the U.S., $21.1 million in Japan, and $5.4 million in Europe and rest of world. The company reported a net loss of $300.6 million, or $1.94 per share, compared with a net loss of $244.8 million, or $1.78 per share, a year earlier. The loss was affected by a non-cash expense of $103.7 million from the change in fair value of deferred and contingent consideration liabilities, which the company attributed primarily to the increase in its share price during the quarter. The company reiterated its 2024 global ARIKAYCE revenue guidance of $340 million to $360 million. It said it plans to file a New Drug Application for brensocatib in bronchiectasis in the fourth quarter of 2024, with a U.S. launch anticipated in mid-2025 pending approvals. As of June 30, 2024, cash and cash equivalents totaled $1.25 billion, and shareholders' equity was $38.8 million. During the quarter the company completed a public offering with net proceeds of $713.2 million, and it redeemed its 1.75% convertible senior notes due January 2025, with 99.9% of the notes converted into common stock before the August 9, 2024 redemption date. The filing also outlines pipeline milestones, including positive topline data from the Phase 3 ASPEN study of brensocatib in May 2024, agreement with the FDA on the primary endpoint for the Phase 3 ENCORE study of ARIKAYCE, and a plan to report ENCORE topline data in the first quarter of 2026. The press release also includes ARIKAYCE's boxed warning for respiratory adverse reactions and its safety information.

Aug 8, 2024 8-K

Other EventsExhibits & Filings

Insmed 8-K Report, Regulation FD Disclosure (Jul 3, 2024)

Insmed Incorporated (Nasdaq: INSM) filed this Form 8-K under Item 7.01 (Regulation FD Disclosure) to announce additional results from the Phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis. The new data will be presented on July 4, 2024 at the 7th World Bronchiectasis Conference in Dundee, Scotland, by lead investigator James Chalmers. The filing states that the study previously met its primary endpoint: annualized pulmonary exacerbation rates were 1.015 for the 10 mg group, 1.036 for the 25 mg group, and 1.286 for placebo, a 21.1% risk reduction for 10 mg (p=0.0019) and a 19.4% risk reduction for 25 mg (p=0.0046). The new findings center on lung function and exploratory endpoints. For the 25 mg dose, FEV1 decline at Week 52 was significantly less than placebo, with an LS mean difference of 38 mL (p=0.0054), while placebo patients lost an average of 62 mL. Nominally significant FVC improvement of 75 mL versus placebo (p<0.0001) and a nominally significant 3.8-point improvement in the QOL-B Respiratory Symptom Domain score (p=0.0004) were also reported for the 25 mg dose. Brensocatib was described as well tolerated, with a safety profile comparable to placebo. The company plans to file a New Drug Application with the FDA in the fourth quarter of 2024 and anticipates a U.S. launch in mid-2025, with launches in Europe and Japan in the first half of 2026, pending regulatory approvals. Brensocatib is investigational and has not been approved in any jurisdiction. For investors, the filing is primarily a data-communication update that reinforces the company's regulatory timeline. The 8-K itself contains no financial statements, and the press release and slide deck are furnished rather than filed under Section 18 of the Exchange Act.

Jul 3, 2024 8-K

Insmed 8-K Report, Corporate Update (Jun 27, 2024)

Insmed Incorporated (Nasdaq: INSM) announced on June 27, 2024 that it has called for redemption all $225 million aggregate principal amount of its outstanding 1.75% Convertible Senior Notes due 2025. The redemption is set for August 9, 2024 (the Redemption Date), at a cash price equal to 100% of principal plus accrued and unpaid interest to, but excluding, that date. The press release states the redemption price is approximately $1,001.17 for each $1,000 principal amount of Notes. Holders may still convert their Notes at any time before 5:00 p.m. New York City time on August 8, 2024, or later if the Company fails to pay the Redemption Price on the Redemption Date. The Company has elected to settle any conversions in shares of common stock. As of June 27, 2024, the conversion rate is 25.5384 shares per $1,000 principal amount, equivalent to a conversion price of approximately $39.16 per share, and up to 5,746,140 shares would be issued if all Notes are converted. For investors, the filing is primarily a debt-management event. Settling conversions in stock would introduce up to 5,746,140 new common shares, a potential dilution consideration, while holders who do not convert will receive cash at the redemption price. The filing itself is a notice and does not discuss the company's financial results or the reasons for the redemption beyond the Indenture terms.

Jun 27, 2024 8-K

Insmed 8-K Report, Corporate Update (Jun 13, 2024)

Insmed Incorporated reported in a Form 8-K filed June 13, 2024 under Item 8.01 (Other Events) that the negotiation period following AstraZeneca AB's exercise of its second and final option under the License Agreement dated October 4, 2016 expired on June 12, 2024. As previously disclosed, AstraZeneca had given notice of that Final Option exercise on March 8, 2024, which covered further developing and, if approved, commercializing brensocatib for chronic obstructive pulmonary disease (COPD) or asthma. No agreement was reached between the company and AstraZeneca to permit AstraZeneca to further develop and commercialize brensocatib in COPD or asthma. As a result, the company retains full worldwide development and commercialization rights for brensocatib in all indications other than COPD or asthma, and AstraZeneca has no further development or commercialization rights for brensocatib in COPD, asthma or any other indication. For investors, the filing resolves the open question of AstraZeneca's participation in brensocatib development for respiratory indications beyond the company's core programs, leaving the company with sole rights to brensocatib outside COPD and asthma. The filing does not state any financial terms, payments, or effects on financial results.

Jun 13, 2024 8-K

Insmed 8-K Report, Regulation FD Disclosure (Jun 4, 2024)

Insmed Incorporated filed a Regulation FD disclosure announcing a commercial webinar on June 4, 2024 at 8:00 a.m. Eastern Time to discuss the market outlook for its three most advanced programs: ARIKAYCE (amikacin liposome inhalation suspension), brensocatib, and treprostinil palmitil inhalation powder (TPIP). The attached slide presentation, Exhibit 99.1, is furnished under Item 7.01 and is not deemed filed under Section 18 of the Exchange Act. The presentation frames the three programs as having positive clinical data in hand. It cites peak sales potential of more than $1 billion for ARIKAYCE, more than $2 billion for TPIP, and more than $5 billion for brensocatib. It describes ARIKAYCE as currently approved for refractory MAC NTM, with an sNDA submission for MAC lung disease planned. It presents brensocatib as potentially a new standard of care in bronchiectasis, based on the ASPEN study, and TPIP as a once-daily inhaled prostanoid being developed for PH-ILD and PAH. The presentation notes that brensocatib and TPIP are investigational and have not been approved by the FDA or any regulatory authority. It also lists upcoming catalysts, including ENCORE enrollment completion, ARISE top-line results, a Phase 2 HS initiation, and additional TPIP Phase 2 and Phase 3 milestones, and it includes a forward-looking statements caveat.

Jun 4, 2024 8-K

Insmed 8-K Report, Regulation FD Disclosure (May 30, 2024)

Insmed Incorporated (Nasdaq: INSM) filed this Form 8-K to report the terms of an underwritten public offering of its common stock. On May 29, 2024, the company entered into an Underwriting Agreement with Goldman Sachs & Co. LLC and Leerink Partners LLC, as representatives of the underwriters, to sell 12,621,359 firm shares at a price of $49.1825 per share after underwriting discounts and commissions. The underwriters also held a 30-day option for 1,893,203 additional shares, which they exercised in full on May 30, 2024. The filing states that net proceeds to the company, before other estimated offering expenses, are approximately $713.9 million. The offering is being made under the company's automatically effective Form S-3 shelf registration statement (No. 333-272088), and closing is expected on May 31, 2024, subject to customary conditions. The pricing press release furnished as Exhibit 99.2 states the public offering price was $51.50 per share and that gross proceeds are expected to be approximately $650 million. The company intends to use net proceeds to fund continued research and development of brensocatib, pre-commercial and, if approved, commercialization activities for brensocatib, further commercialization and development of ARIKAYCE, research and development of treprostinil palmitil inhalation powder (TPIP), and other research product candidates, and for general corporate purposes, including business expansion activities. Exhibit 99.1, the May 28, 2024 press release, announced the proposed offering of $500 million of common stock, with a 30-day option for up to an additional 15% of shares. The filing also includes a legal opinion from Hunton Andrews Kurth LLP regarding the shares (Exhibit 5.1). The forward-looking statements in the press releases flag risks including ARIKAYCE commercialization and full approval, regulatory approvals for brensocatib and TPIP, reliance on third-party manufacturers, and the company's history of operating losses and its ability to repay existing indebtedness.

May 30, 2024 8-K

Leadership ChangesShareholder Matters

Insmed 8-K Report, Regulation FD Disclosure (May 28, 2024)

Insmed Incorporated (INSM) announced positive topline results from its Phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis on May 28, 2024. The study met its primary endpoint: both the 10 mg and 25 mg doses produced statistically significant reductions in the annualized rate of pulmonary exacerbations versus placebo, with reductions of 21.1% (p=0.0019) and 19.4% (p=0.0046), respectively. Several prespecified secondary endpoints were also statistically significant, including time to first exacerbation, odds of remaining exacerbation free over 52 weeks, and change in FEV1 for the 25 mg dose (38 mL, p=0.0054). Reductions in the annualized rate of severe exacerbations and the 10 mg FEV1 change were not statistically significant. The company plans to file a New Drug Application with the FDA in the fourth quarter of 2024, and anticipates a U.S. launch in mid-2025, followed by launches in Europe and Japan in the first half of 2026, pending regulatory approvals. Brensocatib has Breakthrough Therapy Designation from the FDA and PRIME access from the European Medicines Agency. If approved, it would be the first treatment for bronchiectasis and the first approved DPP1 inhibitor. Reported safety was broadly comparable to placebo: any TEAE occurred in 77.7% (10 mg), 76.7% (25 mg) and 79.6% (placebo) of patients, and TEAEs leading to death were 0.5%, 0.7% and 1.2%, respectively. Hyperkeratosis was more frequent with the 25 mg dose (3.0%) than with placebo (0.7%). The company is also advancing brensocatib in chronic rhinosinusitis without nasal polyps (Phase 2 underway) and plans a Phase 2 study in hidradenitis suppurativa in the second half of 2024. Detailed ASPEN results are expected at an upcoming medical meeting.

May 28, 2024 8-K

Insmed 8-K Report, Executive Changes (May 13, 2024)

Insmed Incorporated (INSM) held its annual meeting of shareholders on May 13, 2024, where shareholders approved Amendment No. 1 to the Insmed Incorporated Amended and Restated 2019 Incentive Plan, which the Board of Directors had previously adopted. The plan's material terms are summarized in the company's definitive proxy statement filed April 1, 2024, and the plan itself was filed as Exhibit 10.5 to the Form 10-K for fiscal year 2023. Of the 148,555,217 shares entitled to vote as of the March 12, 2024 record date, 139,739,078 shares were present in person or by proxy. Shareholders elected four Class III directors, David R. Brennan, Leo Lee, Carol A. Schafer, and Melvin Sharoky, M.D., to serve until the 2027 Annual Meeting. Brennan received 120,537,761 votes for and 8,278,236 withheld, Lee received 125,634,442 for and 3,181,555 withheld, Schafer received 113,910,394 for and 14,905,603 withheld, and Sharoky received 117,140,717 for and 11,675,280 withheld. Shareholders also approved, on an advisory basis, the 2023 compensation of named executive officers (120,643,045 for, 8,076,144 against, 96,808 abstentions), ratified Ernst & Young LLP as the independent registered public accounting firm for the year ending December 31, 2024 (135,507,026 for, 4,170,279 against, 61,773 abstentions), and approved Amendment No. 1 to the 2019 Incentive Plan (122,169,823 for, 6,589,414 against, 56,760 abstentions).

May 13, 2024 8-K

Earnings & ResultsOther EventsExhibits & Filings

Insmed 8-K Report, Financial Results (May 9, 2024)

Insmed Incorporated reported first-quarter 2024 total revenue of $75.5 million, up 16% from $65.2 million in the first quarter of 2023. ARIKAYCE net sales were $56.3 million in the U.S., $14.9 million in Japan, and $4.3 million in Europe and rest of world. The net loss narrowed to $157.1 million, or $1.06 per share, from $159.8 million, or $1.17 per share, a year earlier. Cash and cash equivalents were $595.7 million at March 31, 2024. The company reiterated its 2024 global ARIKAYCE revenue guidance of $340 million to $360 million. The filing's main news is TPIP data. In the Phase 2 PH-ILD study, 79.3% of TPIP patients reached the 640 microgram maximum dose by Week 5, versus 100.0% on placebo. Clinical worsening occurred in 10.3% of TPIP patients versus 50.0% of placebo patients (p=0.0164), and deaths occurred in 6.9% versus 20.0%. The study enrolled 39 participants in a 3:1 randomization, and the company said it interprets the results with appropriate caution given the study's small size. The 6-minute walk distance improvement of 30 meters vs. placebo came with a wide confidence interval of -49.0 to 171.0 and a p-value of 0.3484. In the Phase 2 PAH study, blended blinded data from the first 40 patients showed a mean 19.9% reduction in pulmonary vascular resistance and a 43-meter mean improvement in 6-minute walk distance. The company also said topline data from the Phase 3 ASPEN trial of brensocatib in bronchiectasis remain on track for the latter part of the second quarter of 2024. If ASPEN is successful and approval is obtained, Insmed anticipates a U.S. launch in mid-2025. Shareholders' deficit was $464.8 million at March 31, 2024, and total debt, including the current portion, was reported on the balance sheet.

May 9, 2024 8-K

Earnings & ResultsMaterial AgreementsExhibits & Filings

Insmed 8-K Report, Corporate Update (Mar 11, 2024)

Insmed Incorporated (INSM) disclosed under Item 8.01 (Other Events) that on March 8, 2024 it received notice that AstraZeneca AB exercised its second and final option under the License Agreement dated October 4, 2016 between the two companies. The option concerns further developing and, if approved, commercializing brensocatib in chronic obstructive pulmonary disease (COPD) or asthma. The exercise permits AstraZeneca to develop brensocatib beyond Phase 2b clinical trials and, if approved, to commercialize it in COPD or asthma. This is conditional: it takes effect only upon reaching an agreement, following good-faith negotiations, on terms including financial terms satisfactory to both Insmed and AstraZeneca. Both parties retain full discretion to determine whether any proposed terms are acceptable. Insmed retains full development and commercialization rights for brensocatib in all other indications. For investors, the filing signals a potential future partnership expansion into respiratory indications beyond Insmed's own programs, but it does not state any agreed terms, payments, or timing.

Mar 11, 2024 8-K

Insmed 8-K Report, Material Agreement (Feb 22, 2024)

On February 22, 2024, Insmed Incorporated entered into a Sales Agreement with Leerink Partners LLC, as agent, under which the company may sell common stock having an aggregate offering price of up to $500,000,000 through an at-the-market offering. Leerink receives a commission of 3.0% of gross proceeds, and the company is not obligated to sell any shares. The company intends to use net proceeds for ARIKAYCE commercialization and development, brensocatib research, development and pre-commercial and, if approved, commercialization activities, treprostinil palmitil inhalation powder development, and general corporate purposes. The agreement replaces a prior Leerink sales agreement from February 25, 2021 for up to $250,000,000, which was terminated effective the same day with no termination penalties. In the same filing, Insmed furnished a press release reporting fourth-quarter and full-year 2023 results. Total revenue was $83.7 million for the fourth quarter and $305.2 million for the full year, with full-year ARIKAYCE growth of 24%. The full-year net loss was $749.6 million, or $5.34 per share, and cash, cash equivalents and marketable securities totaled $780.4 million at December 31, 2023. The company reiterated 2024 global ARIKAYCE revenue guidance of $340 million to $360 million, and said topline data from the Phase 3 ASPEN trial of brensocatib are expected in the latter part of the second quarter of 2024. For investors, the key points are the new $500 million equity capacity, which may dilute existing shareholders if used, alongside the company's large 2023 operating losses and near-term clinical catalysts, including the ASPEN and PH-ILD readouts expected in the second quarter of 2024.

Feb 22, 2024 8-K

Insmed 8-K Report, Regulation FD Disclosure (Jan 5, 2024)

Insmed Incorporated (Nasdaq: INSM) filed this Form 8-K under Item 7.01 (Regulation FD Disclosure) on January 5, 2024 to furnish a press release (Exhibit 99.1) and a slide presentation (Exhibit 99.2) for its presentation at the 42nd Annual J.P. Morgan Healthcare Conference on January 8, 2024. The press release reports preliminary, unaudited full-year 2023 global net product sales of ARIKAYCE of approximately $305.2 million, including $224.2 million in the United States, $65.7 million in Japan and $15.3 million in Europe. The company states this is 24% year-over-year growth from 2022, with U.S. growth of 21% and Japan growth of 16%. Insmed expects 2024 global ARIKAYCE revenues of $340 million to $360 million, which it describes as 15% year-over-year growth at the midpoint. The filing lays out 2024 catalysts. The Phase 3 ASPEN topline readout for brensocatib in bronchiectasis is expected in the latter part of the second quarter of 2024, with a U.S. launch anticipated in mid-2025 if successful. Topline data from the Phase 2 PH-ILD study of TPIP is expected ahead of ASPEN in the second quarter of 2024; that study enrolled 39 patients against a target of 32. Enrollment in the Phase 2 PAH study of TPIP continues, with topline results expected in 2025. The company says its early-stage research will comprise less than 20% of overall spend. The company states that the ASPEN Data Safety Monitoring Committee's fifth and final meeting in November 2023 identified no new safety signals and recommended the trial continue as planned. Management also says ENCORE topline data remain expected in 2025, and that it will seek an FDA meeting to finalize the ENCORE statistical plan and enrollment target. The filing notes that the presentation and press release contain forward-looking statements subject to risks that could cause actual results to differ materially.

Jan 5, 2024 8-K

Insmed 8-K Report, Financial Results (Oct 26, 2023)

Insmed Incorporated reported third-quarter 2023 financial results and a business update on October 26, 2023, via a press release furnished as Exhibit 99.1. Total revenue was $79.1 million, described as the company's strongest quarter of sales to date and 17% growth over the $67.7 million reported for the third quarter of 2022. ARIKAYCE net sales were $59.2 million in the U.S., $16.0 million in Japan, and $3.8 million in Europe and rest of world. The company reiterated its full-year 2023 global ARIKAYCE revenue guidance of $295 million to $305 million. The company reported a third-quarter net loss of $158.9 million, or $1.11 per share, compared with a net loss of $131.1 million, or $1.09 per share, a year earlier. R&D expenses were $109.1 million and SG&A expenses were $90.6 million, with SG&A rising mainly on higher compensation and stock-based compensation from increased headcount and commercial readiness spending for brensocatib. Cash, cash equivalents and marketable securities totaled $786 million at September 30, 2023, down from $918 million at June 30, 2023. Shareholders' equity was a deficit of $289.4 million at quarter-end. On the pipeline, the company said positive topline data from the Phase 3 ARISE study of ARIKAYCE was announced in September 2023 and that it plans to explore accelerating the filing for approval in newly infected patients with MAC lung disease. Topline data from the Phase 3 ASPEN trial of brensocatib in bronchiectasis remains on track for the second quarter of 2024, and topline data from the Phase 2 TPIP study in PH-ILD is expected in the first half of 2024.

Oct 26, 2023 8-K

Insmed 8-K Report, Regulation FD Disclosure (Sep 5, 2023)

Insmed Incorporated (Nasdaq: INSM) announced on September 5, 2023 positive topline results from the Phase 3 ARISE study of ARIKAYCE in patients with newly diagnosed or recurrent nontuberculous mycobacterial lung infection caused by Mycobacterium avium complex (MAC) who had not started antibiotics. The study met its primary objective of demonstrating that the QOL-B respiratory domain works effectively as a patient-reported outcome (PRO) instrument in MAC lung disease. Insmed plans to propose to the FDA that this PRO be the primary endpoint for the ENCORE study without modifications. The study enrolled 99 patients randomized 1:1; ARIKAYCE-treated patients had a 12.24 versus 7.76 improvement from baseline in QOL-B respiratory score at Month 7 (p=0.1073), which the company describes as a strong trend toward significance but not statistically significant given the study was not powered for that comparison. ARIKAYCE-treated patients also achieved nominally statistically significantly higher culture conversion rates at Month 7 versus the comparator arm (78.8% vs. 47.1%, p=0.0010). The company also plans to explore with global regulators accelerating the filing for approval of ARIKAYCE in newly infected MAC lung disease patients based on ARISE data. The ENCORE trial continues enrolling, with 250 patients expected by the end of 2023 and topline data anticipated in 2025. Safety findings included no new or unexpected safety signals. Discontinuation rates were 22.9% in the ARIKAYCE arm versus 7.8% in the comparator arm, and dysphonia was the most common treatment-emergent adverse event (41.7% vs. 3.9%). Investors should note that the study was not powered for statistical significance on the primary PRO comparison, and the company states that culture conversion results are nominally significant because no adjustment for multiplicity was conducted.

Sep 5, 2023 8-K

Leadership ChangesShareholder MattersCorporate Changes+1

Insmed 8-K Report, Financial Results (Aug 3, 2023)

Insmed Incorporated (Nasdaq: INSM) filed this Form 8-K on August 3, 2023, furnishing under Item 2.02 a press release (Exhibit 99.1) reporting its financial results for the second quarter and six months ended June 30, 2023. Total product revenue for the quarter was $77.2 million, up 18% from $65.2 million in the second quarter of 2022, and reflected ARIKAYCE net sales of $57.7 million in the U.S., $15.6 million in Japan, and $4.0 million in Europe and rest of world. The company reported a net loss of $244.8 million, or $1.78 per share, compared with a net loss of $95.6 million, or $0.80 per share, a year earlier. R&D expense rose to $197.0 million, which includes a $76.5 million non-cash cost tied to the June 2023 acquisition of Adrestia Therapeutics, while SG&A expense was $84.4 million. Management raised its full-year 2023 global ARIKAYCE revenue guidance to $295 million to $305 million, up from $285 million to $300 million. Cash, cash equivalents and marketable securities totaled $918 million at June 30, 2023, down from $999 million at March 31, 2023. Shareholders' deficit was $(155.7) million at June 30, 2023, compared with equity of $87.9 million at December 31, 2022. The pipeline update centers on several upcoming catalysts: topline ARISE data for ARIKAYCE is expected in September 2023, interim blinded dose-titration data for TPIP in PH-ILD and PAH is expected in the second half of 2023, and topline ASPEN Phase 3 data for brensocatib in bronchiectasis remains on track for the second quarter of 2024.

Aug 3, 2023 8-K/A

Shareholder Matters

Insmed 8-K/A Report, Shareholder Vote Results (Jul 7, 2023)

Insmed Incorporated filed this Form 8-K/A to amend its Current Report on Form 8-K filed May 11, 2023, which reported the results of the company's annual meeting of shareholders held that day. The sole purpose of the amendment is to disclose how often the company will hold future shareholder advisory votes on the compensation of its named executive officers ("say on pay"). At the annual meeting, shareholders cast approximately 99.85% of votes in favor of holding say on pay votes on an annual basis, in line with the Board of Directors' recommendation. Based on that result, the company has determined to hold future say on pay votes annually until the next advisory vote on the frequency of say on pay votes. That next frequency vote is required to occur no later than the company's 2029 annual meeting of shareholders. For investors, the filing is a governance update rather than a financial disclosure. It confirms a clear shareholder preference for annual say on pay votes and sets the timing for the next frequency vote. No other changes were made to the original filing.

Jul 7, 2023 8-K

Insmed 8-K Report, Executive Changes (May 11, 2023)

Insmed Incorporated (INSM) held its annual meeting of shareholders on May 11, 2023, where shareholders approved the Insmed Incorporated Amended and Restated 2019 Incentive Plan, which the Board had previously adopted. A summary of the plan's material terms appears in the company's definitive proxy statement filed March 31, 2023, and the full plan was included as Appendix A to that proxy statement. On the same date, the Board amended the Company's Amended and Restated Bylaws, principally to enhance shareholder director-nomination disclosure and procedural requirements tied to the SEC's universal proxy rules (Rule 14a-19), and to provide that the number of directors is set by Board resolution. The amended bylaws are filed as Exhibit 3.1. Shareholders elected three Class II directors, Elizabeth McKee Anderson, Clarissa Desjardins, Ph.D. and David W.J. McGirr, to serve until the 2026 Annual Meeting. Shareholders also approved, on an advisory basis, the 2022 compensation of named executive officers, with 107,704,649 votes for and 4,953,460 against. Shareholders voted for future advisory say-on-pay votes every one year, with 112,492,825 votes for that frequency. Shareholders ratified Ernst & Young LLP as the independent registered public accounting firm for the year ending December 31, 2023, with 118,039,703 votes for. Of the 136,428,466 shares entitled to vote as of the March 14, 2023 record date, 122,778,117 shares were present in person or by proxy at the meeting. The filing reports no financial results; its substantive items are governance and compensation-plan approvals, with the shareholder votes and bylaw changes as the primary items of interest for investors.

May 11, 2023 8-K

Insmed 8-K Report, Regulation FD Disclosure (May 8, 2023)

Insmed Incorporated (Nasdaq: INSM) filed this Form 8-K under Item 7.01 (Regulation FD Disclosure) to furnish materials for its May 8, 2023 investor and analyst event, "The Future of Rare at Insmed: Functional Genes, AI-Enhanced Proteins, Glowing Algae, and More." The press release (Exhibit 99.1) announces progress across the company's early-stage research programs, which it refers to as its fourth pillar. The Company highlights three areas: a targeted adeno-associated virus (AAV) gene therapy delivery system with a stated potential to reduce dose 10- to 50-fold, RNA End-Joining (REJ) technology for larger gene delivery, and the Deimmunized by Design (DbD) protein platform, along with an AlgaeneX algae-based manufacturing approach. The press release states that Insmed plans to initiate a gene therapy clinical trial in Duchenne muscular dystrophy (DMD) later in 2023, with muscle biopsy data expected in the first half of 2024. It also announces a $500,000 equity investment from CureDuchenne Ventures to support the DMD gene therapy program. Other disclosed targets include Stargardt disease, with an IND expected by the end of 2024, and argininosuccinic aciduria and chronic refractory gout, for which preclinical data are expected in 2024. The company anticipates at least six Investigational New Drug (IND) applications by the end of 2025. The filing's Exhibit 99.2 slide presentation supplies additional program detail, including the company's 2023 revenue guidance of $285 million to $300 million for ARIKAYCE in refractory MAC lung disease and its stated plan to keep Pillar 4 operating costs below 20% of total Insmed expenditures. The materials are furnished rather than filed under Section 18 of the Exchange Act, and the forward-looking statements caution that early-stage programs may not achieve their stated timelines.

May 8, 2023 8-K