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INSM · Insmed

50 filings

10-Q

INSM 10-Q Quarterly Reports

Insmed - 50 quarterly reports

Filing record · 2016–202610-K1110-Q338-K134

INSM filed 11 annual reports (10-K), 33 quarterly reports (10-Q) and 134 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · Oct ’16Oct ’16
  2. FY2018 annual report10-K · Feb ’19Feb ’19
  3. Leadership change8-K · Jun ’21Jun ’21
  4. Leadership change8-K · May ’25May ’25
  1. 2026-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2026

    Insmed Incorporated reported third-quarter 2026 product revenues, net of $524.4 million, up from $142.3 million a year earlier, an increase of $382.1 million or 268%. The growth was driven by US sales of BRINSUPRI, which were $398.1 million in the quarter compared with $28.1 million in the prior-year period. ARIKAYCE revenues were $124.4 million, up $10.1 million or 9%, led by international sales. For the nine months ended September 30, 2026, product revenues were $1,255.9 million, up 267% from $342.6 million. Net loss narrowed to $100.3 million for the quarter from $370.0 million, and to $277.1 million for the nine months from $948.3 million. The improvement was partly helped by a $139.2 million nine-month gain from the change in fair value of contingent consideration, which the filing attributes mainly to a decrease in the share price. Operating expenses still rose sharply, with SG&A up 36% in the quarter and R&D up 45%, largely reflecting BRINSUPRI commercial activity and TPIP development spending. At September 30, 2026, Insmed had cash and cash equivalents of $396.6 million and marketable securities of $750.1 million, compared with $510.4 million and $919.6 million at December 31, 2025. Net cash used in operating activities was $348.0 million for the nine months, down from $687.4 million a year earlier. Working capital was $1.1 billion, down from $1.3 billion. The company states it has sufficient funds for at least the next 12 months, while noting that it expects substantial future cash requirements and may raise additional capital. Long-term debt consists of $500.0 million in Term Loans at a fixed 9.6% rate, with principal repayments beginning in 2028. The accumulated deficit stands at $5.9 billion. Customer concentration is significant, with one customer accounting for 38% of gross product revenues in the nine months ended September 30, 2026. Other developments include Japanese approval of BRINSUPRI in August 2026, with a launch in October 2026, and a US sNDA for ARIKAYCE in MAC lung disease that was accepted with priority review and a target action date of January 28, 2027. Chief Financial Officer Sara Bonstein is separating from the company on October 30, 2026. Chief Executive Officer William Lewis will serve as interim principal financial officer, and Patrick Kane as interim principal accounting officer, while the company searches for a successor.

    Oct 29, 2026
  2. 2026-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2026

    Insmed Incorporated reported a sharp improvement in its second-quarter 2026 results, driven by the commercial launch of BRINSUPRI. Product revenues, net were $425.5 million for the three months ended June 30, 2026, compared with $107.4 million a year earlier, an increase of $318.1 million, or 296%. US BRINSUPRI sales contributed $308.6 million, and ARIKAYCE sales rose $8.9 million, primarily from international growth. For the six months, product revenues were $731.5 million, up 265% from $200.2 million. Net loss narrowed to $13.2 million ($0.06 per share) in the quarter from $321.7 million a year earlier. The improvement was largely due to a $99.8 million gain from the change in fair value of contingent consideration, which the filing attributes mainly to a decrease in the company's share price. Operating costs rose, with SG&A expenses up 60% to $247.5 million, primarily from professional fees and compensation tied to BRINSUPRI commercial activities, and R&D expenses up 19% to $210.0 million. Liquidity remains substantial but declined over the period. Cash and cash equivalents were $544.8 million and marketable securities were $615.5 million at June 30, 2026, compared with $510.4 million and $919.6 million at December 31, 2025. Net cash used in operating activities was $311.6 million for the six months. Management states the company has sufficient funds to meet its needs for at least the next 12 months. Debt consists of $500.0 million in Term Loans bearing a fixed 9.6% rate, with principal due in 2028 and 2029, alongside a royalty financing agreement with OrbiMed. The filing also describes near-term pipeline events, including a July 2026 US supplemental new drug application for ARIKAYCE in newly diagnosed MAC lung disease and positive 12-month open-label extension data for TPIP in PAH reported in July 2026.

    Aug 6, 2026
  3. 2026-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2026

    Insmed Incorporated reported product revenues, net of $305.964 million for the three months ended March 31, 2026, up from $92.823 million a year earlier. The increase was driven by $207.182 million of US BRINSUPRI sales following its August 2025 approval, while ARIKAYCE revenue rose to $98.110 million from $92.823 million. Net loss narrowed to $163.563 million, or $(0.76) per share, from $256.583 million, or $(1.42) per share. The improvement was helped by a $46.961 million gain from the change in fair value of contingent consideration. Operating costs rose sharply, with SG&A expenses of $247.259 million, up from $147.545 million, mainly from professional fees and other external expenses tied to BRINSUPRI commercial activities. R&D expenses increased to $209.485 million from $152.577 million. At March 31, 2026, the company held $582.188 million in cash and cash equivalents and $641.326 million in marketable securities, down from $510.445 million and $919.602 million at December 31, 2025. Net cash used in operating activities was $222.738 million. The company also made a $15.0 million milestone payment to AstraZeneca. It states it has sufficient funds to meet its needs for at least the next 12 months. Term Loans of $500.0 million bear a fixed rate of 9.6% per annum. Management describes the company's future cash requirements as substantial and says it may raise additional capital. Clinical and regulatory activity included positive topline results from the Phase 3b ENCORE study of ARIKAYCE in March 2026, which met its primary endpoint of change from baseline in respiratory symptom score at Month 13 (3.11 points, p=0.0299) and its multiplicity-controlled culture conversion endpoints. The company plans to file a US supplemental new drug application in the second half of 2026. In April 2026, the Phase 2b CEDAR study of brensocatib in hidradenitis suppurativa did not meet its primary or secondary endpoints, and that program was discontinued. The company also initiated a Phase 3 study of TPIP in PAH in April 2026.

    May 7, 2026
  4. 2025-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2025

    Insmed Incorporated reported a third quarter of 2025 with product revenues, net, of $142.3 million, up $48.9 million, or 52.4%, from $93.4 million a year earlier. The increase reflects $28.1 million of US sales of BRINSUPRI, the company's second commercial product, which received FDA approval on August 12, 2025, and 22.3% growth in global ARIKAYCE sales. Operating expenses rose sharply: SG&A increased 56.7% to $186.4 million, driven by commercial readiness for BRINSUPRI, and R&D increased 23.6% to $186.4 million. A $104.7 million non-cash charge from the change in fair value of deferred and contingent consideration, attributed mainly to the higher share price, contributed to a net loss of $370.0 million for the quarter, or $(1.75) per share, compared with a net loss of $220.5 million, or $(1.27) per share, in the prior-year quarter. For the nine months ended September 30, 2025, the net loss was $948.3 million. The balance sheet was strengthened by financing activity. The company completed an underwritten offering of 8,984,375 shares at $96.00 per share in June 2025, with net proceeds of $823.3 million, and its 0.75% convertible senior notes were redeemed in June 2025 after holders converted most of them into common stock. At September 30, 2025, the company held $334.8 million in cash and cash equivalents and $1,345.2 million in marketable securities, with working capital of $1.5 billion. Term loans of $500.0 million principal bear a fixed 9.6% rate and mature September 30, 2029. Net cash used in operating activities was $687.4 million for the nine months. Management states that current funds are sufficient to meet financial needs for at least the next 12 months, while noting it may raise additional capital. Near-term catalysts include topline data from the BiRCh trial of brensocatib in chronic rhinosinusitis without nasal polyps, expected by early January 2026; topline data from the ENCORE trial of ARIKAYCE and from the CEDAR trial of brensocatib in hidradenitis suppurativa, both expected in the first half of 2026; and a planned Phase 3 TPIP study in PAH in early 2026. The filing also notes that the CHMP adopted a positive opinion for BRINSUPRI in October 2025. Customer concentration is significant: for the nine months ended September 30, 2025, three customers accounted for 30%, 26% and 21% of gross product revenue.

    Oct 30, 2025
  5. 2025-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2025

    Insmed Incorporated's Form 10-Q for the quarter ended June 30, 2025 shows product revenues, net of $107.4 million for the three months ended June 30, 2025, up from $90.3 million, and $200.2 million for the six months, up from $165.8 million. The company reported a net loss of $321.7 million for the quarter ($1.70 per share) and $578.3 million for the six months ($3.12 per share). Operating expenses rose sharply, with SG&A of $154.8 million for the quarter and R&D of $177.2 million, the filing attributing the SG&A increase largely to commercial readiness activities for brensocatib. The balance sheet strengthened considerably during the period. Cash and cash equivalents were $1,284.3 million at June 30, 2025, compared with $555.0 million at December 31, 2024, and marketable securities were $572.4 million. The increase was driven mainly by an underwritten offering in June 2025 of 8,984,375 shares at $96.00 per share, which provided estimated net proceeds of $823.1 million, and by the conversion and redemption of the 2028 Convertible Notes, which were settled in roughly 17.9 million shares. Debt, long-term fell to $538.5 million from $1,103.4 million. Net cash used in operating activities was $467.7 million for the six months. The company states it has sufficient funds to meet its needs for at least the next 12 months. Clinical and regulatory milestones described in the filing include the FDA's acceptance of the brensocatib NDA with priority review and a PDUFA target action date of August 12, 2025, positive topline Phase 2b results for TPIP in PAH announced in June 2025, and the first patient dosed in the INS1201 Phase 1 ASCEND trial in July 2025. The filing also notes that the ENCORE topline data for ARIKAYCE are anticipated in the first half of 2026.

    Aug 7, 2025
  6. 2025-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2025

    Insmed Incorporated's first-quarter 2025 Form 10-Q, filed May 8, 2025, shows ARIKAYCE product revenues, net of $92.8 million, up 22.9% from $75.5 million a year earlier, with US sales of $64.3 million, Japan $22.1 million, and Europe and rest of world $6.5 million. Operating expenses rose sharply: R&D reached $152.6 million (up 26.0%) and SG&A reached $147.5 million (up 58.5%), with the company citing commercial readiness activities for brensocatib. The operating loss widened to $248.1 million and the net loss to $256.6 million, or $1.42 per share, compared with a net loss of $157.1 million in the prior-year quarter. Cash used in operating activities was $262.1 million for the quarter. The balance sheet shows cash and cash equivalents of $403.2 million and marketable securities of $796.2 million as of March 31, 2025, down from $555.0 million and $878.8 million at year-end 2024. Total shareholders' equity fell to $99.2 million from $285.4 million, and debt, long-term, was $1.11 billion. The company states it has sufficient funds for at least the next 12 months, and it reports that the FDA accepted its brensocatib NDA with priority review and set a PDUFA target action date of August 12, 2025. The filing also notes that Insmed called its outstanding 2028 Convertible Notes for redemption on April 24, 2025, with a redemption date of June 6, 2025. Key pipeline milestones include TPIP PAH Phase 2b topline results expected in June 2025 and brensocatib CRSsNP Phase 2b topline data expected by the end of 2025.

    May 8, 2025
  7. 2024-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2024

    Insmed Incorporated reported product revenues, net, of $93.4 million for the three months ended September 30, 2024, up from $79.1 million a year earlier, an increase of 18.2% driven by ARIKAYCE sales in the US, Japan and Europe and the rest of the world. For the nine months, product revenues were $259.3 million, up 17.0% from $221.5 million. The company still reported a net loss of $220.5 million for the quarter ($1.27 per share) and $678.2 million for the nine months. Operating expenses rose, with R&D expense of $150.8 million for the quarter versus $109.1 million a year earlier, and SG&A expense of $118.9 million versus $90.6 million, which management attributed partly to commercial readiness activities for brensocatib. The change in fair value of deferred and contingent consideration liabilities was $106.5 million for the nine months, which the filing says was primarily due to the increase in the company's share price. The balance sheet strengthened substantially during 2024. Cash and cash equivalents were $461.5 million and marketable securities were $1.0 billion at September 30, 2024, and working capital was $1,390.7 million. Shareholders' equity moved to $483.4 million from a deficit of $(331.9) million at December 31, 2023. The increase was supported by a May 2024 common stock offering with net proceeds of $713.2 million and $371.3 million of net proceeds from the new at-the-market program in the third quarter. The company also redeemed its 2025 Convertible Notes on August 9, 2024, with holders converting $224.8 million of principal into 5,741,063 shares. Management states it currently has sufficient funds for at least the next 12 months, while operating cash outflow was $487.9 million for the nine months. The key pipeline milestone is brensocatib in bronchiectasis. The company reported positive topline results from the Phase 3 ASPEN trial in May 2024, with both doses showing statistically significant reductions in the annualized rate of adjudicated pulmonary exacerbations versus placebo. The company remains on track to file a New Drug Application with the FDA in the fourth quarter of 2024 and, if priority review is granted and the drug is approved, anticipates a US launch in mid-2025. The filing also notes that AstraZeneca's second and final option on brensocatib for COPD or asthma expired in June 2024 without an agreement, so Insmed retains full worldwide rights outside those indications.

    Oct 31, 2024
  8. 2024-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2024

    Insmed Incorporated reported a quarterly report for the period ended June 30, 2024, showing product revenues, net of $90.3 million for the three months ended June 30, 2024, up 17.0% from $77.2 million, driven by growth in ARIKAYCE sales in the US, Japan, and Europe and the rest of the world. Net loss was $300.6 million for the quarter and $457.7 million for the six months ended June 30, 2024. Operating expenses included R&D of $146.7 million and SG&A of $106.6 million in the quarter, and the quarterly change in fair value of deferred and contingent consideration liabilities was a $103.7 million charge, which the filing attributes primarily to the increase in the company's share price. The balance sheet strengthened significantly during the period. Cash and cash equivalents rose to $1,246.8 million as of June 30, 2024, from $482.4 million at December 31, 2023, reflecting net proceeds of $713.2 million from a May 2024 common stock offering at $51.50 per share and the maturity of $300.0 million of marketable securities. Shareholders' equity turned positive at $38.8 million, compared with a deficit of $331.9 million at year-end 2023. The company states it has sufficient funds for at least the next 12 months, while noting that future cash requirements are expected to be substantial. Clinically, the company reported positive topline results from the Phase 3 ASPEN trial of brensocatib in May 2024, with both doses showing statistically significant reductions in the annualized rate of pulmonary exacerbations versus placebo (21.1% for 10 mg and 19.4% for 25 mg). It plans to file a new drug application with the FDA in the fourth quarter of 2024. The company also called its 1.75% 2025 Convertible Notes for redemption on August 9, 2024, and as of August 7, 2024, holders of $224.7 million of those notes had elected to convert.

    Aug 8, 2024
  9. 2024-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2024

    Insmed Incorporated reported a net loss of $157.1 million for the three months ended March 31, 2024, compared with $159.8 million in the same period of 2023. Product revenues, net, rose to $75.5 million from $65.2 million, an increase the filing states as 15.8%, driven by ARIKAYCE sales in the US, Japan, and Europe and the rest of the world. Operating expenses included R&D of $121.1 million and SG&A of $93.1 million, the latter up $13.2 million, primarily from compensation, stock-based compensation, and commercial readiness activities for brensocatib. Net cash used in operating activities was $184.0 million. Cash and cash equivalents were $595.7 million at March 31, 2024, up from $482.4 million at December 31, 2023, mainly because $300.0 million of marketable securities matured during the quarter. Working capital was $337.9 million, down from $703.4 million at year-end 2023. Total shareholders' deficit was $464.8 million. The company stated it has sufficient funds for at least the next 12 months, but it expects future cash requirements to be substantial and may raise additional capital. In the first quarter of 2024 it entered into a new at-the-market equity program of up to $500.0 million, under which no shares had been sold as of the filing date. The filing highlights several near-term catalysts. Topline data from the Phase 3 ASPEN trial of brensocatib in bronchiectasis are anticipated in the latter half of the second quarter of 2024, and the company reported topline safety and certain exploratory efficacy data from the Phase 2 TPIP study in PH-ILD in May 2024. The 2025 convertible notes ($224.2 million carrying value) are classified as current, which makes the current portion of long-term debt a near-term obligation.

    May 9, 2024
  10. 2023-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2023

    Insmed Incorporated's Form 10-Q for the quarter ended September 30, 2023 shows continued growth in ARIKAYCE sales alongside widening losses. Product revenues, net were $79.1 million for the three months ended September 30, 2023, up from $67.7 million, an increase of 16.7%. For the nine months, product revenues, net were $221.5 million, up 19.1% from $186.1 million. Net loss grew to $158.9 million for the quarter (versus $131.1 million) and $563.5 million for the nine months (versus $321.4 million). Nine-month R&D expenses of $434.0 million include $86.7 million of non-cash costs from the Adrestia and Vertuis asset acquisitions, and SG&A rose to $255.0 million, which the company attributes partly to commercial readiness activities for brensocatib. The balance sheet reflects heavier cash use and a shift to a shareholders' deficit. Cash and cash equivalents fell to $487.1 million from $1,074.0 million at December 31, 2022, and marketable securities rose to $298.8 million. Net cash used in operating activities was $405.4 million for the nine months. Total shareholders' equity moved from $88.0 million to a deficit of $(289.4) million. Long-term debt of $1,147.5 million consists of $800.0 million face value of convertible notes, a $350 million Term Loan, and a $150.0 million royalty financing agreement with OrbiMed. The company states it has sufficient funds for at least the next 12 months but may raise additional capital, and it expects operating losses to continue. Clinical and regulatory updates center on the pipeline. Positive topline results from the ARISE trial were announced in the third quarter of 2023, and the company plans to propose the QOL-B respiratory domain as the primary endpoint for the ENCORE study. Topline data from the Phase 3 ASPEN trial of brensocatib are expected in the second quarter of 2024, and topline results from the TPIP PH-ILD study are expected in the first half of 2024. The filing also discloses customer concentration: the three largest customers accounted for 35%, 35% and 18% of gross product revenue for the nine months ended September 30, 2023.

    Oct 26, 2023
  11. 2023-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2023

    Insmed Incorporated reported a widening net loss for the quarter and six months ended June 30, 2023, driven mainly by non-cash acquisition costs and higher operating spend. Net loss was $244.8 million for the three months, compared with $95.6 million a year earlier, and $404.6 million for the six months, compared with $190.3 million. Research and development expense rose to $197.0 million in the quarter, including a $76.5 million non-cash charge from the Adrestia acquisition. Selling, general and administrative expense rose to $84.4 million, reflecting commercial readiness activities for brensocatib. Product revenues from ARIKAYCE grew. Net product revenues were $77.2 million in the quarter, an increase of 18.4% from $65.2 million, and $142.4 million for the six months, an increase of 20.4%. The company stated that US sales drove much of the growth. Net cash used in operating activities was $269.1 million for the six months. At June 30, 2023, cash and cash equivalents were $612.9 million and marketable securities were $304.9 million, down from $1,074.0 million in cash at December 31, 2022. Total shareholders' equity was a deficit of $155.7 million, compared with equity of $88.0 million at year-end 2022. The company states it has sufficient funds for at least the next 12 months, but it expects future cash requirements to be substantial and may raise additional capital. The filing outlines near-term catalysts: topline efficacy and safety data from the ARISE trial in the third quarter of 2023, interim data from the TPIP studies in the second half of 2023, initiation of Phase 2 development of brensocatib in CRSsNP in the fourth quarter of 2023, and topline data from the Phase 3 ASPEN trial in the second quarter of 2024. Management also disclosed ongoing reimbursement negotiations in Germany and Italy that remain unresolved.

    Aug 3, 2023
  12. 2023-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2023

    Insmed Incorporated reported a net loss of $159.8 million for the three months ended March 31, 2023, compared with $94.6 million in the same period of 2022, on product revenues, net, of $65.2 million (up from $53.1 million, an increase of 22.8%). Growth came from ARIKAYCE sales in the US, Japan, and Europe and the rest of the world. Operating expenses rose to $213.4 million, driven mainly by R&D of $127.9 million (up $43.5 million, including a $10.3 million non-cash cost of the Vertuis asset acquisition) and SG&A of $79.9 million (up $23.2 million, largely from commercial readiness activities for brensocatib). Investment income of $10.5 million partly offset interest expense of $20.0 million, which rose after the fourth-quarter 2022 Term Loan and Royalty Financing Agreement. The balance sheet shows cash and cash equivalents of $968.9 million and marketable securities of $29.8 million at March 31, 2023, down from $1,074.0 million and $74.2 million at December 31, 2022. Total shareholders' deficit was $(44.7) million, compared with equity of $88.0 million at year-end 2022. Net cash used in operating activities was $146.3 million for the quarter. The company states it currently has sufficient funds to meet its financial needs for at least the next 12 months, while noting that it expects substantial future cash requirements and may raise additional capital. Clinical milestones disclosed include completion of enrollment in the Phase 3 ASPEN trial of brensocatib in the first quarter of 2023, with topline data expected in the second quarter of 2024. Topline efficacy and safety data from the ARISE trial for ARIKAYCE are anticipated in the third quarter of 2023, and the company expects to advance brensocatib into Phase 2 development for CRSsNP in the fourth quarter of 2023.

    May 4, 2023
  13. 2022-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2022

    Insmed Incorporated's Form 10-Q for the quarter ended September 30, 2022 reports product revenues, net of $67.7 million for the three months ended September 30, 2022, up from $46.8 million a year earlier, driven by ARIKAYCE sales in Japan, the US and Europe. Net loss was $131.1 million for the quarter, compared with $112.7 million in the prior-year quarter. For the nine months, product revenues, net were $186.1 million and net loss was $321.4 million. Research and development expenses rose to $99.9 million for the quarter, mainly on manufacturing and clinical trial costs for the Phase 3 ASPEN trial of brensocatib and the ARIKAYCE frontline trial program. At September 30, 2022, cash and cash equivalents were $414.6 million and marketable securities were $98.7 million, against $800.0 million of convertible notes outstanding. Total shareholders' equity was a deficit of $(29.9) million, down from $410.5 million at December 31, 2021, largely reflecting the adoption of ASU 2020-06, which reduced additional paid-in capital by $264.6 million net of tax. The company states it has sufficient funds for at least the next 12 months. Subsequent to the quarter, on October 19, 2022, Insmed entered into a $350 million senior secured term loan with Pharmakon Advisors, a $150 million secured royalty financing agreement with OrbiMed, and completed an underwritten offering of 13,750,000 shares at $20.00 per share, with aggregate gross proceeds of $775 million across the three financings. The filing also discusses ongoing Phase 3 programs for brensocatib and the post-marketing confirmatory trials for ARIKAYCE, and notes the German pricing dispute that limits direct access to ARIKAYCE in that market.

    Oct 27, 2022
  14. 2022-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2022

    Insmed Incorporated's Form 10-Q for the quarter ended June 30, 2022 shows product revenue growing to $65.2 million in the second quarter, up from $45.4 million a year earlier, driven by the launch of ARIKAYCE in Japan and US growth. Six-month product revenue was $118.3 million versus $85.6 million. Net loss narrowed to $95.6 million for the quarter from $117.3 million, but the six-month net loss was $190.3 million. The company reported R&D expenses of $88.5 million for the quarter, up from $64.7 million, mainly for the Phase 3 ASPEN trial of brensocatib and the ARIKAYCE frontline trial program. Interest expense fell to $3.4 million from $10.3 million after the company stopped accreting debt discount upon adopting ASU 2020-06. Liquidity declined over the period. Cash and cash equivalents were $416.1 million at June 30, 2022, down from $716.8 million at December 31, 2021, and marketable securities totaled $148.6 million. Total shareholders' equity fell to $44.2 million from $410.5 million, reflecting the ASU 2020-06 adoption adjustment and the six-month net loss. The company has $800.0 million of convertible notes outstanding and states it believes it has sufficient funds for at least the next 12 months, while noting it may need to raise additional capital to fund the ASPEN study, ARIKAYCE commercialization, and brensocatib launch readiness. The filing also notes that in Germany, the company has been unable to reach a price agreement with the GKV-SV, and that supply will be enabled by import from other EU countries effective September 1, 2022. Three customers accounted for 36%, 32% and 19% of gross product revenue in the six months ended June 30, 2022.

    Aug 4, 2022
  15. 2022-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2022

    Insmed Incorporated reported a net loss of $94.6 million for the three months ended March 31, 2022, compared with a net loss of $91.6 million in the same period of 2021. Product revenues, net, rose to $53.1 million from $40.2 million, driven by the launch of ARIKAYCE in Japan and growth in US sales. US product revenues were $40.8 million, Japan $10.7 million, and Europe and rest of world $1.6 million. Operating expenses increased, led by research and development expenses of $84.4 million (up from $61.4 million) tied to the Phase 3 ASPEN trial of brensocatib and the ARIKAYCE frontline clinical trial program. The balance sheet shows cash and cash equivalents of $515.7 million and marketable securities of $149.0 million at March 31, 2022, against $1,153.3 million in total assets and total liabilities of $1,033.4 million. Shareholders' equity fell to $119.9 million from $410.5 million, largely reflecting the cumulative impact of the ASU 2020-06 adoption, which reduced additional paid-in capital by $264.6 million. Net cash used in operating activities was $105.2 million. The company states it believes it has sufficient funds for at least the next 12 months, while noting it expects future cash requirements to be substantial and may need to raise additional capital. The company also reported a $11.6 million gain from the change in fair value of deferred and contingent consideration liabilities, which it attributes primarily to the change in its share price. Interest expense declined to $3.3 million from $7.6 million following the cessation of debt discount accretion under ASU 2020-06. Convertible notes outstanding total $800.0 million in face value.

    May 5, 2022
  16. 2021-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2021

    Insmed Incorporated's Form 10-Q for the quarter ended September 30, 2021 reports product revenues, net of $46.8 million for the three months ended September 30, 2021, up 7.1% from $43.6 million a year earlier, and $132.3 million for the nine months, up 7.6%. Net loss widened to $112.7 million for the quarter ($0.96 per share) and $321.7 million for the nine months ($2.93 per share). The increase was driven mainly by R&D expenses of $70.3 million for the quarter (up from $41.4 million) and SG&A expenses of $60.3 million (up from $46.6 million), as the company advances its ARIKAYCE frontline trials, the Phase 3 ASPEN trial of brensocatib, and TPIP studies. The balance sheet strengthened over the period. Cash and cash equivalents were $846.6 million at September 30, 2021, versus $532.8 million at December 31, 2020, reflecting the May 2021 issuance of $575.0 million of 0.75% convertible senior notes due 2028, a $270.1 million net equity offering, and the partial repurchase of $225.0 million of 1.75% notes due 2025. Total debt principal was $800.0 million. The company stated it believes it has sufficient funds for at least the next 12 months, while noting it may need to raise additional capital. In August 2021 Insmed acquired Motus Biosciences and AlgaeneX, recording goodwill of $136.1 million and in-process R&D of $29.6 million, with total consideration of approximately $165.5 million including contingent and deferred consideration. The filing also discloses that the Chief Compliance Officer resigned effective October 28, 2021, citing disagreement with the company's COVID-19 vaccine requirement for US employees.

    Oct 28, 2021
  17. 2021-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2021

    Insmed Incorporated reported a net loss of $117.3 million for the three months ended June 30, 2021, compared with $61.9 million a year earlier, and a net loss of $209.0 million for the six months. Product revenues, net, consist of ARIKAYCE sales and rose to $45.4 million for the quarter, an increase of 6.8%, and to $85.6 million for the six months, an increase of 7.8%. Research and development expenses were $64.7 million for the quarter versus $35.7 million a year earlier, and the company attributes the increase mainly to clinical development and research costs for its ongoing trials, including the ARIKAYCE frontline trial program and the Phase 3 ASPEN trial of brensocatib. Net cash used in operating activities was $203.7 million for the six months. The balance sheet strengthened during the period. Cash and cash equivalents were $928.3 million at June 30, 2021, compared with $532.8 million at December 31, 2020, and working capital was $938.5 million. The increase reflected a May 2021 offering of $575.0 million of 0.75% convertible senior notes due 2028, a May 2021 common stock offering of 11.5 million shares at $25.00 per share with net proceeds of $270.1 million, and the repurchase of $225.0 million of 1.75% convertible notes due 2025, which produced a $17.7 million loss on extinguishment of debt. The company states it believes it has sufficient funds for at least the next 12 months, while noting that it expects substantial future cash requirements and may need to raise additional capital. In August 2021, after the period end, the company acquired Motus Biosciences, Inc. and AlgaeneX, Inc., both privately held preclinical-stage companies. The Motus consideration includes 3,135,374 shares of common stock and up to $35 million in net sales-based milestones, and the AlgaeneX closing included $1.5 million in cash plus contingent shares.

    Aug 5, 2021
  18. 2021-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2021

    Insmed Incorporated reported a net loss of $91.6 million for the three months ended March 31, 2021, compared with a net loss of $66.4 million in the same period of 2020, with basic and diluted net loss per share of $(0.89) versus $(0.74). Product revenues, net, rose to $40.2 million from $36.9 million, an increase of 9.1%, driven by higher US sales of ARIKAYCE. Research and development expenses increased to $61.4 million from $36.2 million, primarily reflecting clinical development costs for the ARIKAYCE frontline trial program (ARISE and ENCORE) and the Phase 3 ASPEN trial of brensocatib. Selling, general and administrative expenses were essentially flat at $51.6 million. The balance sheet reflects a weaker liquidity position. Cash and cash equivalents fell to $409.8 million at March 31, 2021 from $532.8 million at December 31, 2020, as net cash used in operating activities totaled $128.3 million, which the company attributed to clinical and commercial spending and a $12.5 million milestone payment to AstraZeneca tied to the first dosing in the ASPEN trial. Total shareholders' equity declined to $201.6 million from $275.9 million. Convertible notes carried at $361.6 million (face value $450.0 million, due 2025) remain outstanding. Management states the company believes it has sufficient funds for at least the next 12 months, while acknowledging it may need to raise additional capital and has a $250.0 million at-the-market equity program with SVB Leerink, under which no shares had been sold as of March 31, 2021. Regulatory developments included Japan's approval of ARIKAYCE in March 2021 for patients with MAC lung disease who did not sufficiently respond to a multidrug regimen, following the European Commission approval in October 2020. The company launched ARIKAYCE in Germany in the fourth quarter of 2020 and in the Netherlands in February 2021, and expects a Japanese launch in the middle of 2021. Brensocatib and TPIP remain in clinical development, with the ASPEN Phase 3 trial enrolling patients.

    May 6, 2021
  19. 2020-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2020

    Insmed Incorporated reported third-quarter 2020 total revenues, net of $43.6 million, up 12.2% from $38.9 million a year earlier, driven by growth in ARIKAYCE sales. For the nine months ended September 30, 2020, revenues rose 35.5% to $123.0 million. Net loss widened to $63.7 million for the quarter from $60.7 million, and to $191.9 million for the nine months from $201.3 million. Research and development expenses rose 20.6% in the quarter to $41.4 million, while selling, general and administrative expenses fell 12.7% to $46.6 million, mainly due to lower professional fees and external expenses. The balance sheet strengthened over the period. Cash and cash equivalents were $588.8 million at September 30, 2020, up from $487.4 million at December 31, 2019, reflecting net proceeds of $245.9 million from a second-quarter 2020 common stock offering. Management states the company believes it has sufficient funds for at least the next 12 months, but notes it expects substantial future cash requirements and may need to raise additional capital. The company carries $450.0 million of 1.75% convertible senior notes due 2025. On the regulatory and clinical front, the European Commission approved ARIKAYCE in October 2020 for NTM lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis, and the FDA approved a supplemental application adding CONVERT study durability data to the US label. The brensocatib WILLOW Phase 2 study met its primary endpoint in non-cystic fibrosis bronchiectasis, and the company plans to start the Phase 3 ASPEN trial by the end of 2020. The filing also discloses that COVID-19 did not materially affect financial results through the period, while noting continued uncertainty.

    Oct 29, 2020
  20. 2020-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2020

    Insmed Incorporated (INSM) reported its Form 10-Q for the quarter ended June 30, 2020. Revenue from ARIKAYCE sales was $42.5 million for the three months ended June 30, 2020, up from $30.0 million a year earlier, and $79.4 million for the six months, up from $51.9 million. Net loss narrowed to $61.9 million for the quarter from $66.5 million, and to $128.2 million for the six months from $140.7 million. Operating expenses rose in R&D ($35.7 million, up from $33.5 million) while SG&A fell to $49.7 million from $52.4 million, reflecting the postponement of certain commercial activities. The balance sheet strengthened significantly during the quarter. Cash and cash equivalents reached $641.9 million at June 30, 2020, compared with $487.4 million at December 31, 2019, primarily due to net proceeds of $245.9 million from an underwritten offering of 11,155,000 shares at $23.25 per share. Net cash used in operating activities was $93.9 million for the six months. The Convertible Notes carrying value was $346.0 million against $450.0 million principal, and management stated the company believes it has sufficient funds for at least the next 12 months. Pipeline and regulatory developments include the July 2020 positive CHMP opinion for ARIKAYCE in Europe, with an EC decision anticipated in the second half of 2020, and a Japan new drug application submitted in March 2020. For brensocatib, the Phase 2 WILLOW study met its primary endpoint, and the FDA granted breakthrough therapy designation in June 2020; a Phase 3 program is planned to start by the end of 2020. The company also disclosed that COVID-19 did not materially affect financial results through June 30, 2020, though it expects continued uncertainty.

    Aug 6, 2020
  21. 2020-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2020

    Insmed Incorporated reported a net loss of $66.4 million, or $0.74 per share, for the three months ended March 31, 2020, compared with a net loss of $74.2 million, or $0.96 per share, in the same period of 2019. Revenues, net rose to $36.9 million from $21.9 million, an increase of 68.3%, driven by US sales of ARIKAYCE, which increased 67.6% to $35.2 million. Operating expenses were $88.8 million, including R&D of $36.2 million (up 16.0%) and SG&A of $51.3 million (down 6.3%). Interest expense was $7.4 million, reflecting accretion on the $450.0 million 1.75% convertible senior notes due 2025. Cash and cash equivalents declined to $428.9 million at March 31, 2020 from $487.4 million at December 31, 2019, a decrease of $58.5 million, primarily from operating cash outflows of $57.9 million. Working capital was $421.0 million. The company states it believes it has sufficient funds to meet its financial needs for at least the next 12 months, but says it may need to raise additional capital and may do so opportunistically through equity or debt financing or strategic transactions. The filing reports that the COVID-19 pandemic did not materially affect first-quarter results, though management cannot predict its future impact. Pipeline developments included top-line results from the Phase 2 WILLOW study of brensocatib in non-CF bronchiectasis, which met its primary endpoint for both the 10 mg and 25 mg doses. The company plans a Phase 3 program in the second half of 2020, and it submitted a Japanese new drug application for ARIKAYCE in March 2020 following a European marketing authorization application filed in July 2019.

    Apr 30, 2020
  22. 2019-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2019

    Insmed Incorporated (INSM) reported its Form 10-Q for the quarter ended September 30, 2019. Revenue came from sales of ARIKAYCE, its first commercial product, which received accelerated approval in the US in September 2018. Net product revenues from the US were $37.8 million for the quarter and $87.8 million for the nine months, with total revenues, net of $38.9 million and $90.8 million respectively. Net loss was $60.7 million for the quarter and $201.3 million for the nine months, or $(0.68) and $(2.43) per share. Selling, general and administrative expenses rose to $53.3 million for the quarter from $44.4 million a year earlier, driven mainly by professional fees and milestone payments tied to ARIKAYCE. The balance sheet strengthened over the period. Cash and cash equivalents were $535.6 million at September 30, 2019, up from $495.1 million at December 31, 2018, after the company completed a public offering of 10,657,692 shares at $26.00 with net proceeds of $261.1 million in the second quarter. Against this, net cash used in operating activities was $206.2 million for the nine months, and the company states it expects operating losses to continue. Its $450.0 million of 1.75% convertible senior notes due 2025 carry a carrying value of $331.0 million. Management states that it believes current funds are sufficient for at least the next 12 months, while also noting it may need to raise additional capital. Pipeline milestones include top-line data from the phase 2 WILLOW study of INS1007 in non-CF bronchiectasis expected in the first quarter of 2020, a European marketing authorization application for ARIKAYCE filed in July 2019 and validated by the EMA, and planned Japanese regulatory filings in the first half of 2020. The company also disclosed that its US accelerated approval requires a post-approval confirmatory trial, with full approval contingent on verifying clinical benefit.

    Oct 30, 2019
  23. 2019-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2019

    Insmed Incorporated's Form 10-Q for the quarter ended June 30, 2019 reports that its first commercial product, ARIKAYCE (amikacin liposome inhalation suspension), received accelerated approval in the US in September 2018 for refractory MAC lung disease and began commercial shipments in October 2018. Net revenues for the three months ended June 30, 2019 were $29.97 million, with $28.96 million from US product sales and $1.01 million from early access programs. Net loss for the quarter was $66.51 million ($0.81 per share), compared with $76.44 million ($1.00 per share) a year earlier, and the six-month net loss was $140.67 million. SG&A expenses rose to $52.4 million for the quarter from $37.2 million, driven mainly by commercial activities for ARIKAYCE and higher headcount, while R&D expenses fell to $33.5 million. Liquidity improved significantly during the quarter. Insmed completed an underwritten offering of 10,657,692 shares at $26.00 per share, generating net proceeds of $261.2 million, and cash and cash equivalents stood at $601.3 million at June 30, 2019. The company states it believes current funds are sufficient for at least the next 12 months, but it also says its future cash requirements will be substantial and that it may need to raise additional capital. Its $450.0 million of 1.75% convertible senior notes due 2025 remain outstanding, with a carrying value of $326.1 million. Key pipeline events cited include the July 2019 filing of a marketing authorization application with the European Medicines Agency for ARIKAYCE, planned Japanese filings in the first half of 2020, and expected top-line data from the phase 2 WILLOW study of INS1007 in non-CF bronchiectasis in the first quarter of 2020. Full US approval of ARIKAYCE remains contingent on a confirmatory clinical trial that is still being designed with the FDA.

    Aug 1, 2019
  24. 2019-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2019

    Insmed Incorporated's first-quarter 2019 Form 10-Q reports that its first commercial product, ARIKAYCE (amikacin liposome inhalation suspension), was granted accelerated approval by the FDA on September 28, 2018 for refractory MAC lung disease, with commercial shipments beginning in October 2018. Total revenues were $21.9 million for the quarter ($21.0 million from US net product revenues and $0.9 million from early access programs), against a net loss of $74.2 million, or $0.96 per share, compared with a net loss of $68.5 million in the prior-year quarter. The increase in operating costs was driven mainly by SG&A, which rose to $54.8 million from $32.7 million on headcount growth, including the field force, and ARIKAYCE commercial expenses. Balance sheet liquidity declined over the quarter. Cash and cash equivalents fell to $420.2 million from $495.1 million at December 31, 2018, reflecting $73.8 million of cash used in operating activities. Total shareholders' equity dropped to $144.1 million from $208.3 million. The company's $450.0 million of 1.75% convertible senior notes due 2025 carry a $321.3 million net carrying value. Management states it believes current funds are sufficient for at least the next 12 months, but says future cash requirements will be substantial and it may need to raise additional capital. The filing also highlights several pipeline and regulatory milestones: a required confirmatory trial for ARIKAYCE's full approval with protocol finalization expected in the first half of 2019, planned European regulatory filings in mid-2019 and Japanese filings in the first half of 2020, and expected completion of enrollment in the WILLOW Phase 2 study of INS1007 in mid-2019. Adoption of ASU 2016-02 (Leases) added $47.4 million to the balance sheet, with right-of-use assets of $44.6 million and lease liabilities totaling $45.1 million.

    May 7, 2019
  25. 2018-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2018

    Insmed Incorporated (Nasdaq: INSM) filed its Form 10-Q for the quarter ended September 30, 2018, reporting a net loss of $87.7 million, or $1.14 per share, for the quarter and $232.7 million, or $3.03 per share, for the nine months. Total operating expenses rose to $84.0 million for the quarter from $44.1 million a year earlier, driven by higher general and administrative expenses ($44.4 million versus $17.4 million, including $27.2 million of pre-commercial expenses) and R&D expenses ($39.5 million versus $26.7 million). The company reported no revenue in any period presented. Cash and cash equivalents were $567.6 million at September 30, 2018, up from $381.2 million at December 31, 2017, reflecting net proceeds of $435.8 million from the January 2018 issuance of $450.0 million of 1.75% convertible senior notes due 2025. The quarter's most significant event was the FDA's September 28, 2018 accelerated approval of ARIKAYCE for adult patients with MAC lung disease who have limited or no alternative treatment options, under the Limited Population Pathway for Antibacterial and Antifungal Drugs. The company began commercial shipments in October 2018 and states it does not expect material revenue in 2018. Approval is contingent on a post-approval confirmatory trial, with the protocol scheduled to be finalized in 2019 and results reported by 2024. The company also disclosed that it expects to continue incurring operating losses and may need to raise additional capital, and that it believes current funds are sufficient for at least the next 12 months. For investors, the filing shows a company transitioning from development to commercial launch with a rising cost base and no product revenue yet. Key watch items include early ARIKAYCE uptake, the confirmatory trial design, manufacturing scale-up with third-party suppliers, and the company's cash burn relative to its current cash balance.

    Oct 30, 2018
  26. 2018-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2018

    Insmed Incorporated's Form 10-Q for the quarter ended June 30, 2018 shows a net loss of $76.4 million for the three months and $145.0 million for the six months ended June 30, 2018, compared with $44.7 million and $82.1 million in the prior-year periods. The company has generated no material revenue, and it states that it does not expect material revenue unless or until marketing approval is received for ALIS. Operating expenses rose sharply, with general and administrative expenses of $37.2 million in the quarter (up from $16.6 million), driven by pre-commercial expenses and headcount growth, and R&D expenses of $35.7 million (up from $26.9 million), driven mainly by external manufacturing costs. Cash and cash equivalents were $634.3 million at June 30, 2018, up from $381.2 million at December 31, 2017, primarily due to net proceeds of about $435.8 million from the January 2018 issuance of $450.0 million of 1.75% convertible senior notes due 2025. Net cash used in operating activities was $123.0 million for the six months. The company stated it believes it has sufficient funds for at least the next 12 months, while noting that its future cash requirements are expected to be substantial. The company's lead candidate, amikacin liposome inhalation suspension (ALIS), has a new drug application under FDA priority review with a PDUFA action date of September 28, 2018, and an FDA advisory committee meeting is scheduled for August 7, 2018. The filing also reports that the CONVERT study met its primary endpoint, with culture conversion at month six of 29% in the ALIS plus guideline-based therapy arm versus 9% in the guideline-based therapy-only arm (p<0.0001).

    Aug 2, 2018
  27. 2018-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2018

    Insmed Incorporated reported a net loss of $68.5 million, or $0.89 per share, for the quarter ended March 31, 2018, compared with a net loss of $37.4 million, or $0.60 per share, in the same period of 2017. The company has no revenue. Operating expenses rose to $62.8 million, driven by research and development expenses of $30.1 million (up from $22.3 million) and general and administrative expenses of $32.7 million (up from $13.7 million). The filing attributes the G&A increase mainly to pre-commercial planning, including consulting fees and higher headcount for the field force. Interest expense increased to $5.6 million, reflecting the convertible notes issued in January 2018. The company's lead product candidate is amikacin liposome inhalation suspension (ALIS), for treatment-refractory NTM lung disease caused by MAC. In late March 2018, Insmed filed a New Drug Application with the FDA under accelerated approval (Subpart H) based on six-month CONVERT study data, where 29% of patients on ALIS plus guideline-based therapy achieved culture conversion versus 9% on guideline-based therapy alone (p<0.0001). The company expects a six-month priority review. Liquidity improved substantially. Cash and cash equivalents rose to $686.6 million at March 31, 2018, from $381.2 million at December 31, 2017, after the January 2018 issuance of $450.0 million of 1.75% convertible senior notes due 2025, which yielded net proceeds of about $435.9 million. Insmed repaid $55.0 million of Hercules Capital debt in February 2018, recording a $2.2 million loss on extinguishment. Management believes current funds are sufficient for at least the next 12 months, but states that it expects operating expenses to increase significantly in 2018 and may need to raise additional capital.

    May 2, 2018
  28. 2017-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2017

    Insmed Incorporated's Form 10-Q for the quarter ended September 30, 2017 shows a company with no material revenue, focused on developing ALIS (amikacin liposome inhalation suspension) for treatment refractory NTM lung disease caused by MAC. The company reported top-line CONVERT phase 3 data on September 5, 2017, stating the study met its primary endpoint of culture conversion by month six: 29% of patients on ALIS plus guideline-based therapy achieved culture conversion versus 9% on guideline-based therapy alone (p<0.0001). Management plans to pursue accelerated approval in the US under Subpart H. Financially, net loss was $45.2 million for the third quarter and $127.3 million for the nine months ended September 30, 2017, compared with $37.8 million and $107.9 million in the prior-year periods. Research and development expenses rose to $75.8 million for the nine months, and general and administrative expenses rose to $47.8 million, which the company attributes largely to pre-commercial planning. Cash and cash equivalents were $430.7 million at September 30, 2017, up from $162.6 million at year-end 2016, primarily due to a September 2017 offering of 14.1 million shares that netted $377.7 million. The company states it believes it has sufficient funds for at least the next 12 months. The filing also discloses an ongoing securities class action (Hoey v. Insmed) that the company considers without merit, and a subsequent event in October 2017 in which the company exercised an option to buy down future royalties payable to PARI Pharma GmbH, with the payment to be recorded in general and administrative expenses in the fourth quarter.

    Nov 2, 2017
  29. 2017-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2017

    Insmed Incorporated (filed as Insmed Incorporated, a Virginia corporation) reported its Form 10-Q for the quarter ended June 30, 2017. The company is a global biopharmaceutical company focused on rare diseases, with lead candidate ARIKAYCE (ALIS) in late-stage development for treatment refractory NTM lung disease caused by MAC. The company has generated no material revenue to date and reported a net loss of $44.7 million for the quarter and $82.1 million for the six months ended June 30, 2017. Cash and cash equivalents fell to $91.1 million at June 30, 2017, from $162.6 million at December 31, 2016, with net cash used in operating activities of $73.2 million for the six months. The filing states that the company expects to report top-line results from the phase 3 CONVERT study of ALIS in September 2017, plus or minus one month. If the study meets its primary endpoint, the company intends to seek accelerated marketing approval in the US. Operating expenses rose, with R&D expenses of $49.1 million and G&A expenses of $30.4 million for the six months, driven by start-up phase 2 trial costs for INS1007 and pre-commercial planning. The company states it expects its future cash requirements to be substantial and will need to raise additional capital, and it believes it has sufficient funds for at least the next 12 months if it makes significant reductions in spending. The filing also discloses a pending securities class action (Hoey v. Insmed Incorporated) in which the company moved to dismiss the amended complaint, and the company believes the allegations are without merit. Debt consists of $55.0 million in notes payable to Hercules Capital, Inc. bearing interest at 9.25%, with principal repayments beginning in 2018.

    Aug 3, 2017
  30. 2017-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2017

    Insmed Incorporated, a global biopharmaceutical company focused on rare diseases, reported a net loss of $37.4 million, or $0.60 per share, for the quarter ended March 31, 2017, compared with a net loss of $33.5 million, or $0.54 per share, a year earlier. The company has no revenue in either period. Its lead candidate, ARIKAYCE (liposomal amikacin for inhalation), is in late-stage development for treatment refractory NTM lung disease caused by MAC. The CONVERT phase 3 study has completed enrollment, with top-line results for the Month 6 primary endpoint expected in the second half of 2017. The company intends to seek accelerated approval in the US if the study meets its primary endpoint. Operating expenses rose to $36.0 million from $33.1 million, driven by a $1.7 million increase in R&D and a $1.2 million increase in G&A, which included $5.1 million of pre-commercial expenses. Cash and cash equivalents fell to $125.8 million from $162.6 million at year-end 2016, as net cash used in operating activities was $36.9 million. Working capital was $108.4 million. The company stated it believes it has sufficient funds for at least the next 12 months but will seek additional capital within that period. Debt consists of $55.0 million owed to Hercules Capital at a fixed 9.25% rate, with maturities extending to October 2020. The company also faces a securities class action (Hoey v. Insmed Incorporated), where a motion to dismiss the amended complaint was filed March 1, 2017, and management believes the allegations are without merit.

    May 3, 2017
  31. 2016-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2016

    Insmed Incorporated's Form 10-Q for the quarter ended September 30, 2016 shows a net loss of $37.8 million ($0.61 per share) for the three months and $107.9 million ($1.74 per share) for the nine months, driven by rising research and development and general and administrative spending. The company reported no revenue in any period presented. R&D expenses were $23.4 million for the quarter, up from $19.2 million, mainly due to clinical trial costs for the CONVERT Phase 3 study of ARIKAYCE and higher compensation. G&A expenses were $13.7 million, up from $11.0 million, largely due to pre-commercial activities. Cash and cash equivalents fell to $200.5 million at September 30, 2016 from $282.9 million at December 31, 2015, and the company states it believes it has sufficient funds for at least the next twelve months. In September 2016, Insmed amended its loan agreement with Hercules Capital, increasing borrowings to $35.0 million with an option for an additional $20.0 million, which it exercised in early October 2016 to fund an upfront payment under a license agreement with AstraZeneca. On October 4, 2016, Insmed licensed global exclusive rights to AZD7986, renamed INS1007, an oral DPP1 inhibitor for non-CF bronchiectasis, for a $30.0 million upfront payment plus up to $85.0 million in contingent milestones and tiered royalties. The company also disclosed that ARIKAYCE's EU marketing application was withdrawn in June 2016 after the CHMP concluded the data were insufficient, and that a purported securities class action was filed in July 2016. The company expects CONVERT top-line results for the Month 6 primary endpoint in 2017 and has achieved its enrollment objective. Investors should weigh the company's continued cash burn, the increased debt load, and the dependence of its pipeline on the CONVERT study outcome.

    Nov 3, 2016
  32. 2016-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2016

    Insmed Incorporated reported no revenue for the three and six months ended June 30, 2016, with a net loss of $36.6 million ($0.59 per share) for the quarter and $70.1 million ($1.13 per share) for the six months, compared with net losses of $28.6 million and $56.0 million in the same periods of 2015. Research and development expenses rose to $23.9 million for the quarter and $44.4 million for the six months, driven mainly by the CONVERT phase 3 study of ARIKAYCE, while general and administrative expenses rose to $12.3 million and $24.8 million, reflecting pre-commercial activities and headcount growth. Cash and cash equivalents fell to $223.1 million at June 30, 2016 from $282.9 million at December 31, 2015, and the company states it believes it has sufficient funds for at least the next twelve months. The most significant development is the company's withdrawal in June 2016 of its European marketing authorization application for ARIKAYCE for NTM lung disease, after the CHMP concluded the data did not provide enough evidence to support approval. Insmed intends to resubmit once clinical data from the ongoing CONVERT study are available, and the filing states the company expects to achieve its CONVERT enrollment objective in 2016. The company also disclosed a purported securities class action filed July 15, 2016 in the U.S. District Court for the District of New Jersey, alleging misleading statements about the European MAA, which the company says it believes is without merit. The company has no product revenue to date, relies on its $25.0 million Hercules loan with principal repayments beginning in October 2016, and states that it expects to need additional capital for future development and commercialization and may raise funds opportunistically through equity or debt.

    Aug 4, 2016
  33. 2016-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2016

    Insmed Incorporated reported a net loss of $33.5 million, or $(0.54) per share, for the quarter ended March 31, 2016, compared with a net loss of $27.4 million, or $(0.55) per share, a year earlier. The company had no revenue in either period. Operating expenses rose to $33.1 million from $26.7 million, driven by research and development expenses of $20.5 million (up from $17.2 million) and general and administrative expenses of $12.5 million (up from $9.5 million). The filing attributes the R&D increase mainly to clinical trial costs for the CONVERT study and higher compensation, and the G&A increase mainly to pre-commercial activities and headcount growth in Europe. Cash and cash equivalents fell to $252.9 million at March 31, 2016 from $282.9 million at December 31, 2015, a $30.0 million decrease driven primarily by $29.5 million of cash used in operating activities. Total debt outstanding was $25.0 million under a Hercules loan bearing a fixed 9.25% rate, with principal repayments beginning in October 2016 and the balance due January 1, 2018. Management states the company has sufficient funds to meet its financial needs for at least the next twelve months, while noting it may raise additional capital and that the enrollment pace of the CONVERT study is the most significant factor in 2016 cash requirements. The company's lead candidate, ARIKAYCE (liposomal amikacin for inhalation), is in late-stage development for nontuberculous mycobacteria (NTM) lung disease. The European Medicines Agency's CHMP is reviewing the company's Marketing Authorization Application, with an oral explanation meeting expected in the second quarter of 2016 and an opinion expected around the middle of 2016. The company expects to achieve its enrollment objective in the CONVERT phase 3 study in the second half of 2016.

    May 5, 2016
  34. 2015-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2015

    Insmed Incorporated's Form 10-Q for the quarter ended September 30, 2015 reports no revenue and a widening net loss. For the nine months ended September 30, 2015, net loss was $86.9 million ($1.51 per share), compared with $61.5 million ($1.50 per share) in the prior-year period. Research and development expenses rose to $54.6 million from $41.5 million, driven mainly by the ARIKAYCE phase 3 CONVERT study and INS1009 research. General and administrative expenses rose to $30.3 million from $22.8 million, reflecting European pre-commercial activity and higher compensation and stock-based compensation. The balance sheet strengthened materially. Cash and cash equivalents were $311.0 million at September 30, 2015, up from $159.2 million at December 31, 2014, primarily due to net proceeds of $222.9 million from an April 2015 offering of 11.5 million shares at $20.65 per share. The company stated it believes it has sufficient funds for at least the next twelve months. Its only debt is a $25.0 million Hercules loan at 9.25% that matures in full on January 1, 2016, unless the maturity is extended to January 1, 2018 under the loan's terms. The filing also covers regulatory and pipeline developments. The company withdrew the Pseudomonas indication from its EMA marketing authorization application for ARIKAYCE in the third quarter of 2015 and will pursue only the refractory NTM lung disease indication caused by MAC. It has responses to the EMA's 120-day questions due before the end of 2015, and it expects to begin a phase 1 study of INS1009 in healthy subjects in the fourth quarter of 2015. The company also disclosed a supply dependence on Ajinomoto Althea for ARIKAYCE and a fill/finish agreement with a minimum payment of $2.7 million per calendar year.

    Nov 6, 2015
  35. 2015-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2015

    Insmed Incorporated's Form 10-Q for the quarter ended June 30, 2015 shows a company in clinical development with no revenue. Net loss for the three months ended June 30, 2015 was $28.6 million, or $(0.47) per share, compared with $23.2 million, or $(0.59) per share, a year earlier. For the six months, net loss was $56.0 million, or $(1.01) per share, versus $37.5 million, or $(0.96) per share, in 2014. The company attributes the increases mainly to ARIKAYCE phase 3 CONVERT study costs, INS1009 research, manufacturing build-out, and pre-commercial and tax-structure expenses in Europe. Cash and cash equivalents rose to $335.0 million at June 30, 2015 from $159.2 million at December 31, 2014, driven mainly by $222.9 million in net proceeds from an April 2015 offering of 11.5 million shares at $20.65 per share. Cash used in operating activities was $49.1 million for the six months. Management states it believes current funds are sufficient for at least the next twelve months. The company's $25.0 million Hercules loan is due in full on January 1, 2016, though the company has an option to extend maturity to January 1, 2018 if it meets a financing threshold, which the April 2015 offering qualifies as. The filing describes the regulatory status of ARIKAYCE: a Marketing Authorization Application validated by the European Medicines Agency in February 2015, with responses to 120-day questions expected before the end of 2015, and the phase 3 CONVERT study in NTM lung infections, which began in early 2015 with enrollment expected to take about twelve months. The company also reports an IND filing for INS1009 expected in the fourth quarter of 2015.

    Aug 6, 2015
  36. 2015-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2015

    Insmed Incorporated, a Virginia-incorporated biopharmaceutical company based in Bridgewater, New Jersey, reported a net loss of $27.4 million, or $(0.55) per share, for the quarter ended March 31, 2015, compared with a net loss of $14.3 million, or $(0.36) per share, a year earlier. The company has no revenue. Research and development expenses rose to $17.2 million from $11.4 million, driven by clinical trial costs for the 212 global phase 3 study of ARIKAYCE in NTM lung infections and manufacturing build-out at Therapure's facility. General and administrative expenses rose to $9.5 million from $6.7 million, largely due to noncash stock-based compensation tied to performance options that vested when the EMA accepted ARIKAYCE's marketing authorization application in February 2015. The prior-year quarter also included a $4.4 million income tax benefit from the sale of New Jersey NOLs that did not recur. As of March 31, 2015, cash and cash equivalents were $134.6 million, down from $159.2 million at December 31, 2014, and working capital was $99.1 million. The company had $25.0 million of Hercules debt at 9.25% due January 1, 2016. Net cash used in operating activities was $24.9 million for the quarter. The company states it believed it had sufficient funds to meet its 2015 financial needs. A subsequent event is the most significant for investors. On April 6, 2015, Insmed completed an underwritten offering of 11.5 million shares at $20.65 per share, with net proceeds of approximately $223.0 million. The filing states this equity financing exceeded the $90.0 million threshold that allows the Hercules loan maturity to be extended to January 1, 2018. Development priorities include the 212 phase 3 NTM study, with preliminary top-line results expected in mid-2016, an EMA review of ARIKAYCE for NTM and CF Pseudomonas indications, and a planned Health Canada filing in the second half of 2015.

    May 7, 2015
  37. 2014-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2014

    Insmed Incorporated reported a net loss of $24.0 million, or $(0.54) per share, for the three months ended September 30, 2014, compared with $17.3 million, or $(0.46) per share, a year earlier. For the nine months, the net loss was $61.5 million, or $(1.50) per share, versus $39.9 million, or $(1.19) per share, in 2013. The company has no product revenue. The 2013 nine-month results included an $11.5 million one-time payment from Premacure (now Shire plc) for the right to future royalties, and the company recorded no other revenue in 2014. Operating expenses rose to $23.4 million in the quarter from $16.8 million, driven by higher research and development and general and administrative spending. The company's lead product candidate is ARIKAYCE (liposomal amikacin for inhalation). Its phase 2 trial in NTM lung infections missed the pre-specified statistical significance on the primary endpoint (p=0.148) but achieved significance on culture conversion (11 of 44 treated patients versus 3 of 45 on placebo, p=0.01). The FDA granted Breakthrough Therapy designation in June 2014, and the company plans to file a Marketing Authorization Application with the EMA by the end of 2014 and to start a confirmatory phase 3 trial in early 2015, with preliminary top-line results expected in mid-2016. The company estimates the combined global market for its two orphan indications at approximately $1 billion. As of September 30, 2014, cash and cash equivalents were $167.3 million, and working capital was $149.6 million. The company raised net proceeds of $108.0 million in an August 2014 public offering of 10,235,000 shares at $11.25 per share. Against that, it carries $20.0 million of notes payable to Hercules, with principal maturities of $5.5 million within one year. Management estimates fourth-quarter 2014 cash requirements of $22 million to $26 million and states that it may raise additional capital within the next twelve months.

    Nov 6, 2014
  38. 2014-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2014

    Insmed Incorporated (INSM) reported a net loss of $23.2 million, or $(0.59) per share, for the three months ended June 30, 2014, compared with a net loss of $8.9 million, or $(0.28) per share, in the prior-year quarter. The year-over-year increase was driven mainly by $11.5 million of one-time Other revenue recorded in Q2 2013 from Premacure (now Shire plc), along with higher research and development and general and administrative expenses. For the six months ended June 30, 2014, the net loss was $37.5 million, or $(0.96) per share. Cash and cash equivalents were $82.7 million at June 30, 2014, down from $113.9 million at December 31, 2013, and working capital was $64.9 million. Net cash used in operating activities was $30.6 million for the six-month period. The company's focus remains its lead candidate, ARIKAYCE (liposomal amikacin for inhalation). In March 2014, ARIKAYCE did not meet the pre-specified statistical significance level on the primary endpoint in the NTM phase 2 trial (p=0.148), but achieved statistical significance on the key secondary endpoint of culture conversion (11 of 44 patients versus 3 of 45 on placebo, p=0.01). In June 2014, the FDA granted Breakthrough Therapy Designation for treatment-refractory NTM lung disease. The company intends to file a Marketing Authorization Application with the EMA by the end of 2014 for NTM in treatment-refractory patients and for Pseudomonas lung infections in cystic fibrosis patients, and it plans two Phase 3 studies in NTM. The company stated it will need to raise capital within the next twelve months. It estimated second-half 2014 cash requirements of $42 million to $47 million for operations, and it filed a shelf registration on Form S-3 in May 2014. Total debt was $20.0 million under the Hercules loan at a 9.25% interest rate, with principal maturities beginning in 2015.

    Aug 6, 2014
  39. 2014-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2014

    Insmed Incorporated reported a net loss of $14.3 million, or $(0.36) per share, for the three months ended March 31, 2014, compared with a net loss of $13.7 million, or $(0.43) per share, a year earlier. The company had no revenue in either period. Operating expenses rose to $18.1 million from $14.3 million, driven by research and development of $11.4 million and general and administrative expenses of $6.7 million. A $4.4 million benefit from income taxes, from the sale of New Jersey state net operating losses, partly offset the operating loss. Cash and cash equivalents were $101.3 million at March 31, 2014, down from $113.9 million at December 31, 2013, and working capital was $86.2 million. Management states it believes current funds are sufficient for the next twelve months, and estimates second-quarter 2014 cash requirements of $18 million to $20 million. The company's lead product candidate, ARIKAYCE (liposomal amikacin for inhalation), is in development for nontuberculous mycobacteria (NTM) lung infections and Pseudomonas lung infections in cystic fibrosis (CF) patients. In March 2014, the phase 2 NTM trial did not meet its pre-specified statistical significance on the primary endpoint (p=0.148), but achieved significance on the key secondary endpoint of culture conversion (11 of 44 treated patients versus 3 of 45 on placebo, p=0.01). The company applied for Breakthrough Therapy Designation based on that result and plans to discuss the regulatory path with the FDA and EMA. Management states it does not expect ARIKAYCE to be commercially available for at least a year, if at all. Debt consists of $20.0 million in notes payable to Hercules Technology Growth Capital at 9.25%, maturing January 1, 2016. The company also entered into a contract manufacturing agreement with Therapure Biopharma Inc. in February 2014, and a legal appraisal action (Pilkiewicz v. Transave LLC) was settled before trial, with the company expecting full indemnification from holdback shares.

    May 8, 2014
  40. 2013-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2013

    Insmed Incorporated, a Virginia biopharmaceutical company, reported a net loss of $17.3 million ($0.46 per share) for the three months ended September 30, 2013, compared with $9.4 million ($0.38 per share) a year earlier, and a nine-month net loss of $39.9 million ($1.19 per share) versus $25.9 million ($1.04 per share). The company has no product revenue; its only revenue in the period was an $11.5 million one-time payment from Premacure (now Shire plc) in exchange for its right to future royalties. Operating expenses are rising as the company advances its lead candidate, ARIKACE (liposomal amikacin for inhalation). Research and development expense was $12.1 million for the quarter versus $5.7 million a year earlier, and general and administrative expense was $4.7 million versus $3.6 million. At September 30, 2013, cash and cash equivalents totaled $128.0 million, up from $92.9 million of cash, cash equivalents and a certificate of deposit at December 31, 2012. The increase reflects $67.0 million of net proceeds from a July 2013 public offering of 6.9 million shares at $10.40 per share and the $11.5 million Premacure payment, partly offset by $44.1 million used in operations. Management states that this cash will be sufficient to fund operations through 2014, while noting it may need to raise additional capital. Total debt was $20.0 million in notes bearing 9.25% interest, and the company reported a material weakness in controls over administration of its 2000 Stock Incentive Plan, which it concluded made its disclosure controls ineffective. Clinically, the company completed a Phase 3 registrational trial of ARIKACE in cystic fibrosis patients with Pseudomonas aeruginosa infections in Europe and Canada, where once-daily ARIKACE met its primary non-inferiority endpoint against twice-daily TOBI. A Phase 2 trial in non-tuberculous mycobacteria (NTM) lung infections completed enrollment of 90 patients in October 2013, with top-line results expected by the end of the first quarter of 2014. The company expects to submit regulatory filings with the EMA and Health Canada in the first half of 2014.

    Nov 5, 2013
  41. 2013-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2013

    Insmed Incorporated, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective, reported a net loss of $8.9 million ($0.28 per share) for the three months ended June 30, 2013, compared with a net loss of $9.7 million ($0.39 per share) a year earlier. The quarter included an $11.5 million one-time Other revenue payment from Premacure (now Shire plc) in exchange for its right to future royalties under a license agreement. Excluding that payment, operating expenses rose sharply, with research and development expenses up to $12.2 million from $7.7 million and general and administrative expenses up to $7.5 million from $2.2 million, driven by Phase 3 and Phase 2 trial activity and stock-based compensation. For the six months ended June 30, 2013, the net loss was $22.5 million ($0.71 per share). The company's lead product candidate, ARIKACE (liposomal amikacin for inhalation), reported top-line Phase 3 results in cystic fibrosis patients with Pseudomonas aeruginosa lung infections, meeting its non-inferiority primary endpoint versus TOBI. Regulatory filings with the EMA and Health Canada are expected in the first half of 2014, and a Phase 2 trial in non-tuberculous mycobacteria (NTM) infections is ongoing, with top-line results expected by the end of the first quarter of 2014. The filing also discloses a material weakness in internal control over the administration of its 2000 Stock Incentive Plan, which caused the company to conclude that its disclosure controls were not effective. As of June 30, 2013, cash, cash equivalents and a certificate of deposit totaled $76.8 million, against $20.0 million of secured notes. In July 2013 the company completed a public offering of 6,900,000 shares at $10.40 per share, with expected net proceeds of approximately $67.0 million. Management believes existing cash plus offering proceeds will fund operations through 2014.

    Aug 6, 2013
  42. 2013-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2013

    Insmed Incorporated (filed as Insmed Incorporated, a Virginia corporation) reported its first-quarter 2013 Form 10-Q, showing a net loss of $13.7 million, or $0.43 per share, for the three months ended March 31, 2013, compared with a net loss of $6.8 million, or $0.28 per share, a year earlier. Research and development expenses rose to $10.3 million from $4.7 million, driven by its Phase 3 cystic fibrosis trial, the two-year extension study, and the Phase 2 NTM study for lead product candidate ARIKACE (liposomal amikacin for inhalation). General and administrative expenses rose to $4.0 million from $2.5 million, mainly due to professional fees tied to excess equity awards under the 2000 Stock Incentive Plan. The company has generated no revenue from ARIKACE to date. As of March 31, 2013, cash, cash equivalents and a certificate of deposit totaled $81.6 million, down from $92.9 million at December 31, 2012, after $11.2 million of operating cash use. The company states this balance will fund operations into 2014, and it carries $20.0 million of secured notes at 9.25% under a June 2012 Loan Agreement. Management concluded that disclosure controls were not effective and that internal control over financial reporting was ineffective as of December 31, 2012, due to a material weakness in administering the 2000 Stock Incentive Plan. Subsequent events include Premacure's April 2013 exercise of its option to buy out its IGF-1 license for $11.5 million, payable by May 9, 2013, and the lender's exercise of its warrant on a net issuance basis, resulting in 223,431 shares issued. Top-line Phase 3 CF results are expected in mid-2013, and Phase 2 NTM results in the fourth quarter of 2013.

    May 7, 2013
  43. 2012-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2012

    Insmed Incorporated's Form 10-Q for the quarter ended September 30, 2012 shows a company in clinical development with no revenue in the period. Revenues were zero for the three and nine months ended September 30, 2012, compared with $0.4 million and $3.0 million in the same periods of 2011, as IPLEX expanded access program revenue ended after inventory was depleted in December 2011. Net loss attributable to common stockholders was $9.4 million ($0.38 per share) for the quarter and $25.9 million ($1.04 per share) for the nine months, improving from 2011 results that included a $26.0 million non-cash impairment charge. Research and development expense for the nine months was $17.6 million, down from $21.4 million, while general and administrative expense rose to $9.0 million, reflecting separation costs. As of September 30, 2012, total cash, cash equivalents, short-term investments and certificates of deposit were $91.9 million, up from $78.4 million at December 31, 2011. The increase reflects $25.7 million of gross proceeds from a September 2012 registered direct offering of 6,304,102 shares at $4.07 per share and $9.7 million net borrowed under a $20 million Hercules Technology Growth Capital term loan. The company states it believes it has sufficient funds for at least the next twelve months. Its sole development focus is ARIKACE (liposomal amikacin for inhalation), with CLEAR-108 and TARGET-NTM clinical results expected in 2013. Leadership changed during the period: Will Lewis became President and CEO on September 10, 2012, replacing Tim Whitten, and Andrew Drechsler was announced as CFO, effective November 8, 2012, succeeding Kevin Tully. The filing also discloses a Nasdaq Letter of Reprimand relating to the September 2012 offering, which the staff has since closed, and two pending lawsuits (Cacchillo v. Insmed and the Pilkiewicz appraisal action) for which the company states it cannot estimate potential loss.

    Nov 7, 2012
  44. 2012-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2012

    Insmed Incorporated's Form 10-Q for the quarter ended June 30, 2012 reports that the company is a development-stage biopharmaceutical company focused on inhaled liposomal treatments for serious lung infections, with its lead candidate ARIKACE targeting cystic fibrosis patients with Pseudomonas lung infections and patients with non-tuberculous mycobacteria (NTM) lung infections. The company reported no revenue for the three and six months ended June 30, 2012, versus $1.0 million and $2.6 million in the comparable 2011 periods, because IPLEX expanded access program revenue ended when inventory was depleted in December 2011. Net loss attributable to common stockholders was $9.7 million ($0.39 per share) for the quarter and $16.5 million ($0.67 per share) for the six months, compared with $10.0 million and $26.1 million in the prior-year periods; the six-month 2011 figure included a $9.2 million non-cash beneficial conversion charge. As of June 30, 2012, cash, cash equivalents, short-term investments and certificate of deposit totaled $75.2 million, compared with $78.4 million at December 31, 2011. In June 2012 the company entered into a Loan and Security Agreement with Hercules Technology Growth Capital, Inc. for up to $20 million, of which $10 million was funded at closing, with proceeds of $9.7 million net of issuance costs. Management believes existing funds are sufficient for at least the next twelve months. Clinical developments included the lifting of the FDA clinical hold on ARIKACE for NTM in January 2012 and for CF in May 2012, the start of a European phase 3 CF trial (CLEAR-108) and a U.S. phase 2 NTM trial (TARGET-NTM), and a May 2012 license of IGF-1 and IGFBP-3 to Premacure. The company also disclosed two pending legal matters, the Cacchillo lawsuit (trial scheduled for January 2013) and the Pilkiewicz appraisal action, neither of which management can currently estimate a loss from.

    Aug 7, 2012
  45. 2012-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2012

    Insmed Incorporated reported a net loss attributable to common stockholders of $6.8 million, or $0.28 per common share, for the three months ended March 31, 2012, compared with a net loss of $16.1 million, or $0.85 per share, in the prior-year quarter. The prior-year figure included a $9.2 million non-cash beneficial conversion charge tied to the Series B Preferred Stock. Revenue was zero in the quarter versus $1.6 million a year earlier, as IPLEX Expanded Access Program revenue ended after inventory was depleted in December 2011. Research and development expenses fell to $4.5 million from $5.8 million, and general and administrative expenses fell to $2.8 million from $3.3 million. The company describes itself as a development-stage biopharmaceutical company focused on inhaled liposomal treatments for serious lung infections, with ARIKACE as its main development program. As of March 31, 2012, cash, cash equivalents, short-term investments and a certificate of deposit totaled $72.9 million, down from $78.4 million at December 31, 2011. Net cash used in operations was $5.6 million for the quarter. Management states it believes current funds are sufficient to meet financial needs for fiscal 2012, but notes that additional capital may be needed later through licensing, debt or equity sales. The FDA lifted the clinical hold on ARIKACE for NTM in January 2012, and in May 2012 it lifted the hold on the U.S. CF program. The company is continuing a European phase 3 CF trial (CLEAR-108), a U.S. phase 2 NTM trial, and is evaluating next steps for the U.S. CF program. The filing also discloses two pending legal matters: the Cacchillo v. Insmed lawsuit, with trial scheduled for January 2013, and the Pilkiewicz appraisal action against Transave, LLC. For both, the company says it cannot estimate the possible loss. The company also reports $58.2 million of in-process research and development intangible assets and states it sees no impairment indicators.

    May 8, 2012
  46. 2011-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2011

    Insmed Incorporated's Form 10-Q for the quarter ended September 30, 2011 reports a net loss attributable to common stockholders of $34.6 million ($1.39 per share) for the three months and $60.7 million ($2.66 per share) for the nine months, compared with $0.3 million and $0.6 million in the prior-year periods. The third-quarter loss was driven largely by a non-cash impairment charge of $26.0 million on in-process research and development and goodwill, triggered by an FDA clinical hold placed on the company's phase 3 trials of ARIKACE in cystic fibrosis and non-tuberculous mycobacteria (NTM) patients. Research and development expense rose to $6.9 million for the quarter and $21.4 million for the nine months, reflecting ARIKACE program preparation and manufacturing, while revenue fell to $0.4 million and $3.0 million as cost recovery from the IPLEX expanded access program in Europe declined. The FDA's clinical hold remained in place as of October 2011. The agency requested a 9-month dog inhalation toxicity study for CF and a phase 2 trial in adult NTM patients before the phase 3 NTM study can proceed, and the company has suspended initiation of its CF and NTM phase 3 programs with no patients dosed to date. Phase 3 trials in Europe are not on hold. The filing states that cash, cash equivalents, short-term investments and a certificate of deposit totaled $85.3 million at September 30, 2011, down from $110.2 million at December 31, 2010, and that management believes current funds are sufficient for the remainder of 2011, while noting that additional capital may be needed later. The company also completed its December 2010 business combination with Transave, Inc., converted its Series B Preferred Stock into common stock, and effected a one-for-ten reverse stock split in March 2011. Accumulated deficit reached $286.0 million. The company disclosed that it is defending the Cacchillo lawsuit and that a Mackinson appraisal-related action was settled and approved by the court on October 6, 2011.

    Nov 9, 2011
  47. 2011-Q2

    Insmed Quarterly Report for Q2 Ended Jun 30, 2011

    Insmed Incorporated's second-quarter 2011 Form 10-Q reports a net loss attributable to common stockholders of $10.0 million ($0.40 per share) for the three months ended June 30, 2011, and $26.1 million ($1.19 per share) for the six months, which includes a $9.2 million non-cash beneficial conversion charge tied to the conversion of Series B Conditional Convertible Preferred Stock. Revenue fell to $1.0 million for the quarter and $2.6 million for the six months, mainly due to lower cost-recovery revenue from the IPLEX Expanded Access Program in Europe, which the filing says will end in late third or early fourth quarter 2011 as inventory is depleted. Research and development expense rose to $8.7 million for the quarter and $14.5 million for the six months, driven by preparation for Phase 3 studies of Arikace™. Cash, cash equivalents, short-term investments and certificate of deposit totaled $94.0 million at June 30, 2011, versus $110.2 million at December 31, 2010, and the company states it believes it has sufficient funds for fiscal 2011. The most significant development is a subsequent event: on August 1, 2011 the FDA placed a clinical hold on Insmed's Phase 3 trials of Arikace™ in cystic fibrosis and NTM lung disease, based on an initial review of interim results from a long-term rat inhalation carcinogenicity study. The company has suspended Phase 3 initiation and patient enrollment, has no patients dosed, and expects to supply requested information by the end of August 2011, with the FDA expecting to respond within 30 days of receiving a complete response. The company states it cannot yet assess the impact on its Phase 3 programs. Management also notes the company expects no material revenue for at least the next several years. Other items include the business combination with Transave completed December 1, 2010, the settlement of the Mackinson appraisal-type class action, and the pending Cacchillo lawsuit, which the company believes is without merit and cannot estimate the loss from. The company also entered into a lease for a larger facility at 9 Deer Park Drive with total obligations of approximately $1.7 million.

    Aug 8, 2011
  48. 2011-Q2-A

    Insmed Quarterly Report (Amendment) for Q2 Ended Jun 30, 2011

    Insmed Incorporated filed this Amendment No. 1 to its Quarterly Report on Form 10-Q for the period ended June 30, 2011. The sole purpose of the amendment is to furnish the Interactive Data File exhibits (XBRL) required by Item 601(b)(101) of Regulation S-K. No other changes were made to the 10-Q, and the amendment was not updated for events occurring after the original filing. The filing identifies the registrant as a Virginia corporation headquartered at 11 Deer Park Drive, Suite 117, Monmouth Junction, NJ, and reports 24,833,301 shares of common stock, $.01 par value, outstanding as of August 8, 2011. The company is classified as an accelerated filer and is not a shell company. The filing's exhibit list includes Section 302 and Section 906 certifications from the CEO and CFO, filed with the 10-Q, and XBRL instance, schema, calculation, label, and presentation files, which are furnished rather than filed. The document itself contains no financial statements or operating results, so investors should refer to the original 10-Q for those details.

    Aug 8, 2011
  49. 2011-Q1

    Insmed Quarterly Report for Q1 Ended Mar 31, 2011

    Insmed Incorporated (Virginia corporation) filed this Form 10-Q for the quarter ended March 31, 2011. The company completed its business combination with Transave, Inc. on December 1, 2010, and is now focused on proprietary liposomal technology for inhalation lung delivery, with its initial priority being Phase 3 studies of ARIKACE for cystic fibrosis Pseudomonas lung infections and non-tuberculous mycobacteria lung infections, with patient accrual expected to begin in the second half of 2011. For the three months ended March 31, 2011, total revenues were $1.6 million versus $1.9 million a year earlier. Research and development expenses rose to $5.8 million from $0.6 million, and selling, general and administrative expenses rose to $3.3 million from $1.5 million, producing a net loss of $6.9 million. After a $9.2 million non-cash beneficial conversion charge tied to the conversion of Series B preferred stock, the net loss attributable to common stockholders was $16.1 million, or $0.85 per share. Cash, cash equivalents, short-term investments and certificate of deposit totaled $104.9 million at March 31, 2011, compared with $110.2 million at December 31, 2010, and the company stated it believes it has sufficient funds for 2011. The filing also notes that IPLEX expanded access program cost-recovery revenue in Europe is expected to end by about the third quarter of 2011 as inventory is depleted. Two lawsuits are pending: Cacchillo v. Insmed, where a preliminary injunction was denied and affirmed on appeal but the monetary damages claim remains, and Mackinson et al. v. Insmed, a purported class action tied to the Transave merger. The company states it cannot estimate potential losses from either.

    May 10, 2011
  50. 2010-Q3

    Insmed Quarterly Report for Q3 Ended Sep 30, 2010

    Insmed Incorporated's third-quarter 2010 Form 10-Q reports total revenues of $1.8 million for the quarter and $5.6 million for the nine months ended September 30, 2010, down from $2.5 million and $7.9 million in the comparable 2009 periods. The decline is attributed mainly to lower cost recovery from the IPLEX™ Expanded Access Program in Italy for ALS. The company reported a net loss of $0.3 million for the quarter and $0.6 million for the nine months, compared with net income of $116.0 million for the nine months of 2009, which included a $125.0 million after-tax gain on the sale of its follow-on biologics platform to Merck & Co. in March 2009. As of September 30, 2010, cash, cash equivalents and short-term investments totaled $126.4 million, and the company states it has sufficient funds to meet its needs for the upcoming year. The filing states that the company's supply of IPLEX™ is forecast to be exhausted around the second quarter of 2011, at which point its primary source of operating revenue (EAP cost recovery) is expected to end absent an income-generating transaction from its ongoing strategic review process. The company has no President or CEO, is not currently searching for one, and says it may issue a substantial number of shares to complete a business combination. Nasdaq listing risk is also disclosed: the bid price has been below $1.00, and the company has until December 15, 2010 to regain compliance, possibly via a reverse stock split. The filing also discloses a complaint filed October 6, 2010 by Angeline Cacchillo in the U.S. District Court for the Northern District of New York seeking monetary damages and access to IPLEX™. On October 22, 2010, the court denied her motion for a preliminary injunction for lack of subject matter jurisdiction, while her damages claim remains outstanding. Management believes the allegations are without merit and cannot estimate a possible loss.

    Nov 3, 2010