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INSM · Insmed

36 filings

10-K

INSM 10-K Annual Reports

Insmed - 36 annual reports

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

2025
Insmed Annual Report, Year Ended Dec 31, 2025
Insmed Incorporated's 10-K for fiscal year 2025 reports product revenues, net of $606.4 million, up from $363.7 million in 2024, an increase of $242.7 million or 66.7%. The growth reflects $172.7 million of US BRINSUPRI sales following FDA approval in August 2025, plus ARIKAYCE revenue of $433.8 million, which grew 19.3%, with international sales up 40.9%. The company remains loss-making: its 2025 net loss was $1,276.8 million (2024: $913.8 million), and its accumulated deficit reached $5.6 billion. Operating expenses rose sharply, with R&D at $771.1 million and SG&A at $701.2 million, both driven by BRINSUPRI commercialization and pipeline spending. Net cash used in operating activities was $935.0 million. Liquidity is supported by cash and cash equivalents of $510.4 million and marketable securities of $919.6 million at year-end, and the company states these fund operations for at least the next 12 months. Debt consists of $500.0 million in term loans at a fixed 9.6% rate maturing in 2028 and 2029, plus a royalty financing agreement with OrbiMed. The company also reports that its three largest customers accounted for 74% of gross product revenue in 2025. Key pipeline catalysts include ENCORE topline data for ARIKAYCE expected by April 2026, CEDAR Phase 2b topline data for brensocatib in hidradenitis suppurativa in the second quarter of 2026, and a planned Phase 3 TPIP PAH study in the first half of 2026. The filing shows that the BRINSUPRI launch is the main driver of revenue and expense growth. Investors will be focused on whether ARIKAYCE obtains full approval through ENCORE and how quickly BRINSUPRI sales scale against continued heavy spending.
Feb 19, 2026
2024
Insmed Annual Report, Year Ended Dec 31, 2024
Insmed Incorporated reported product revenues, net of $363.7 million for the year ended December 31, 2024, up from $305.2 million in 2023, an increase of $58.5 million, or 19.2%, driven by ARIKAYCE sales growth in the US, Japan, and Europe and the rest of the world. The company's only approved product is ARIKAYCE, which received accelerated approval in the US in 2018 and is subject to a confirmatory post-marketing trial (ENCORE) required for full approval. Net loss was $913.8 million in 2024 versus $749.6 million in 2023, and the accumulated deficit reached $4.4 billion. Operating expenses rose, with R&D up 4.8% to $598.4 million and SG&A up 33.9% to $461.1 million, reflecting commercial readiness activities for brensocatib. The company's pipeline centers on brensocatib, a DPP1 inhibitor for bronchiectasis, whose NDA was accepted with priority review in February 2025 and carries a PDUFA target action date of August 12, 2025. Positive Phase 3 ASPEN topline results were announced in May 2024. Other programs include TPIP for PH-ILD and PAH and INS1201, an intrathecal gene therapy for DMD. Cash and cash equivalents plus marketable securities totaled $1.43 billion at year-end, and the company states this is sufficient to fund operations for at least the next 12 months. Total debt includes $574.9 million of 2028 Convertible Notes, $500.0 million of Term Loans at a 9.6% fixed rate, and a $150.0 million royalty financing arrangement. Investors should weigh the company's large and growing operating losses, reliance on ARIKAYCE revenue, concentration among three customers (85% of gross product revenue in 2024), and the regulatory dependence of both ARIKAYCE full approval and brensocatib launch timing.
Feb 20, 2025
2023
Insmed Annual Report, Year Ended Dec 31, 2023
Insmed Incorporated (INSM) reported 2023 product revenues, net of $305.2 million, up from $245.4 million in 2022, driven by ARIKAYCE sales in the US, Japan and Europe. The company's only approved product is ARIKAYCE, which received accelerated approval in the US in September 2018 and is also approved in Europe and Japan. Net loss widened to $749.6 million in 2023 from $481.5 million in 2022, with R&D expenses rising to $571.0 million (including $86.7 million of non-cash asset acquisition costs for the Adrestia and Vertuis acquisitions) and SG&A rising to $344.5 million. Accumulated deficit reached $3.4 billion, and shareholders' equity was negative $331.9 million at year-end. The company stated that cash and cash equivalents of $482.4 million and marketable securities of $298.1 million are sufficient to fund operations for at least the next 12 months. The filing's near-term value drivers are pipeline readouts and regulatory steps. 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 topline PH-ILD data for TPIP are expected in the second quarter of 2024. ARIKAYCE's full US approval depends on the confirmatory ARISE and ENCORE trials, with ENCORE topline data anticipated in 2025 and FDA feedback on the PRO endpoint expected in the first half of 2024. Leverage increased materially in October 2022 through a $350 million senior secured Term Loan with Pharmakon and a $150 million Royalty Financing Agreement with OrbiMed, alongside $800 million of convertible senior notes outstanding. Risk concentration is significant. The company's three largest customers accounted for 88% of total gross product revenue in 2023, and the filing notes ARIKAYCE's full approval, pricing and reimbursement, and competition from other inhaled and DPP1 inhibitor programs as key uncertainties.
Feb 22, 2024
2022
Insmed Annual Report, Year Ended Dec 31, 2022
Insmed Incorporated's 2022 annual report, filed February 23, 2023, centers on ARIKAYCE, its only approved product, which generated product revenues, net, of $245.4 million in 2022, up from $188.5 million in 2021. Revenue by geography was US $186.0 million, Japan $56.5 million, and Europe and rest of world $2.9 million. Growth was driven by the US and Japan, partly offset by a $7.5 million revenue reduction in Q4 2022 tied to the final French ATU reimbursement price. Net loss widened to $481.5 million from $434.7 million, as R&D expenses rose to $397.5 million and SG&A to $265.8 million. The accumulated deficit reached $2.7 billion. The pipeline includes brensocatib, a Phase 3 ASPEN trial in bronchiectasis with topline data expected in the second quarter of 2024, and TPIP, in Phase 2 studies for PH-ILD and PAH with PH-ILD topline results expected in the first half of 2024. ARIKAYCE's US accelerated approval depends on confirmatory ARISE and ENCORE trials, with ARISE topline data expected in the third quarter of 2023. The company reports cash and cash equivalents of $1,074.0 million and marketable securities of $74.2 million at year-end 2022, and states this supports operations for at least the next 12 months. Financing in October 2022 added a $350 million senior secured term loan from Pharmakon and a $150 million royalty financing agreement with OrbiMed, alongside a 13.75 million share offering at $20.00 per share with net proceeds of $258.8 million. Total long-term debt and royalty financing reached roughly $1.3 billion, including $800 million of convertible notes face value. Customer concentration is high: the three largest customers accounted for 90% of gross product revenue in 2022.
Feb 23, 2023
2021
Insmed Annual Report, Year Ended Dec 31, 2021
Insmed Incorporated reported a net loss of $434.7 million for 2021, up from $294.1 million in 2020, as it continued to commercialize its only approved product, ARIKAYCE, and advance its pipeline. Product revenues, net, rose to $188.5 million from $164.4 million, driven by the US and by launches in Japan (July 2021) and certain European markets. Research and development expenses increased to $272.7 million from $181.2 million, primarily reflecting clinical development for the Phase 3 ASPEN trial of brensocatib and the ARIKAYCE frontline confirmatory trial program. SG&A expenses rose to $234.3 million from $203.6 million on commercial launch efforts in Europe and Japan. The balance sheet strengthened during 2021, with cash and cash equivalents of $716.8 million and marketable securities of $50.0 million at year-end, supported by $575.0 million of 0.75% convertible senior notes due 2028, an $11.5 million share offering at $25.00 per share, and the repurchase of $225.0 million of 1.75% notes due 2025. Management states the company believes it has sufficient funds for at least the next 12 months. The accumulated deficit was $2.3 billion, and the company expects operating losses to continue for the foreseeable future. Key risks for investors include ARIKAYCE's accelerated approval in the US, which requires the ARISE and ENCORE confirmatory trials to support full approval, with confirmatory results expected to be reported by 2024. Revenue concentration is also significant, as the three largest customers accounted for 75% of gross product revenue in 2021. The company acquired Motus Biosciences and AlgaeneX in August 2021, recording $136.1 million of goodwill and $29.6 million of in-process R&D.
Feb 17, 2022
2020
Insmed Annual Report, Year Ended Dec 31, 2020
Insmed Incorporated reported a 2020 net loss of $294.1 million, compared with $254.3 million in 2019, as it commercializes its only approved product, ARIKAYCE, for MAC lung disease. Product revenues, net, rose to $164.4 million from $136.5 million, driven by ARIKAYCE net sales growth. Research and development expenses increased to $181.2 million from $131.7 million, mainly due to the frontline ARIKAYCE confirmatory trial program, the Phase 3 ASPEN trial of brensocatib, and a $12.5 million milestone payment to AstraZeneca. SG&A expenses decreased to $203.6 million from $210.8 million. The company had $532.8 million in cash and cash equivalents at December 31, 2020, and states it believes it has sufficient funds for at least the next 12 months. The filing emphasizes that full US approval of ARIKAYCE depends on a confirmatory post-marketing trial, with confirmatory results to be reported by 2024, and that the company's accumulated deficit was $1.8 billion. The company's convertible senior notes ($450.0 million, 1.75% due 2025) remain outstanding. Pipeline milestones include the Phase 3 ASPEN trial of brensocatib in bronchiectasis, a Phase 1 healthy volunteer study of TPIP with topline results announced in February 2021, and a pending Japanese new drug application for ARIKAYCE. The company's ARIKAYCE revenue remains concentrated among a small number of customers, with the three largest customers representing 28%, 27% and 23% of gross product revenue in 2020. Investors should weigh the growth in product sales against continued operating losses, reliance on third-party manufacturers, and dependence on the outcome of the confirmatory trial program.
Feb 25, 2021
2019
Insmed Annual Report, Year Ended Dec 31, 2019
Insmed Incorporated's 2019 Form 10-K reports that its only approved product, ARIKAYCE (amikacin liposome inhalation suspension), received accelerated approval in the US in September 2018 for refractory MAC lung disease and was launched commercially in October 2018. Total revenues rose to $136.5 million in 2019 from $9.8 million in 2018, with cost of product revenues of $24.2 million, yet the company posted a net loss of $254.3 million ($3.01 per share) compared with $324.3 million ($4.22 per share) in 2018. Accumulated deficit stood at $1.5 billion, and cash and cash equivalents were $487.4 million at December 31, 2019, which the company says is sufficient to fund operations for at least the next 12 months. The pipeline centers on INS1007, an oral DPP1 inhibitor for non-cystic fibrosis bronchiectasis (NCFBE), where the Phase 2 WILLOW study met its primary endpoint of time to first pulmonary exacerbation at 10 mg (p=0.027) and 25 mg (p=0.044). The company plans a Phase 3 program. ARIKAYCE's full US approval depends on a confirmatory trial, with results to be reported by 2024, and the company plans a front-line confirmatory study starting in the second half of 2020. A marketing authorization application was filed in Europe in July 2019, and Japan filings are planned for the first quarter of 2020. Investors should note the company's reliance on a single approved product, dependence on third-party manufacturers, $450.0 million of 1.75% convertible senior notes due 2025, and ongoing operating losses. The filing states that revenue alone is not expected to make the company profitable without reductions in operating expenses.
Feb 25, 2020
2018
Insmed Annual Report, Year Ended Dec 31, 2018
Insmed Incorporated reported its first full year with a commercial product in its 10-K for 2018. ARIKAYCE (amikacin liposome inhalation suspension) received accelerated approval from the FDA on September 28, 2018 for refractory MAC lung disease under the LPAD pathway, with commercial shipments beginning in October 2018. Total 2018 revenues were $9.8 million, comprising $9.3 million of US net product revenues and $0.6 million from France ATU sales, while the net loss widened to $324.3 million, or $4.22 per share, from $192.6 million in 2017. Research and development expenses rose to $145.3 million and SG&A expenses rose to $168.2 million, driven by manufacturing costs and commercial launch preparation. The company's ability to sustain ARIKAYCE depends on a required post-approval confirmatory trial, with the protocol expected to be finalized in the first half of 2019 and results reported by 2024. Continued approval is contingent on verifying clinical benefit in that study. Insmed also flagged reliance on a small number of third-party manufacturers, a sole nebulizer supplier (PARI), and limited prior experience commercializing a drug. At December 31, 2018, cash and cash equivalents were $495.1 million, and the company stated it believes it has sufficient funds for at least the next 12 months. The January 2018 issuance of $450.0 million of 1.75% convertible senior notes due 2025 was the main driver of the higher debt balance, which was $316.6 million net of discount. Shareholders' equity declined to $208.3 million from $361.1 million.
Feb 22, 2019
2017
Insmed Annual Report, Year Ended Dec 31, 2017
Insmed Incorporated, a Virginia corporation, is a global biopharmaceutical company focused on rare diseases. Its lead product candidate, amikacin liposome inhalation suspension (ALIS), is in late-stage development for adult patients with treatment refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC). The company reported top-line CONVERT study results in September 2017, stating the study met its primary endpoint of culture conversion at month six, with 29% of patients in the ALIS plus current guideline-based therapy arm achieving culture conversion versus 9% in the GBT-only arm (p<0.0001). Insmed plans to file a New Drug Application with the FDA by the end of March 2018 under Subpart H accelerated approval, and expects a six-month priority review. Financially, the company reported no revenue for 2017 and a net loss of $192.6 million, compared with $176.3 million in 2016. Research and development expenses were $109.7 million and general and administrative expenses were $79.2 million, the latter increasing due to pre-commercial planning activities. Cash and cash equivalents were $381.2 million at December 31, 2017, and the accumulated deficit was $957.9 million. In January 2018, the company completed a $450.0 million offering of 1.75% convertible senior notes due 2025, with net proceeds of approximately $435.8 million, and it notified Hercules it would repay its $55.0 million loan in full on February 28, 2018. Management stated it expects operating expenses to be significantly higher in 2018 as it prepares for a potential US launch of ALIS in late 2018. Key risks include the possibility that full CONVERT and 312 study data differ from top-line and interim results, uncertainty over FDA acceptance of the Subpart H pathway, dependence on a small number of third-party manufacturers and a sole nebulizer supplier (PARI), and a securities class action that was dismissed without prejudice on February 15, 2018, with the lead plaintiff having until March 19, 2018 to file a second amended complaint.
Feb 23, 2018
2016
Insmed Annual Report, Year Ended Dec 31, 2016
Insmed Incorporated (INSM) is a global biopharmaceutical company focused on rare diseases, and its lead product candidate is ARIKAYCE (liposomal amikacin for inhalation, LAI), in late-stage development for adult patients with treatment refractory NTM lung disease caused by MAC. The company reports it achieved its enrollment objective for the phase 3 CONVERT study in the fourth quarter of 2016 and expects top-line results for the Month 6 primary endpoint in the second half of 2017. If the study meets its primary endpoint, Insmed intends to seek accelerated marketing approval in the US. The company's pipeline also includes INS1007, an oral DPP1 inhibitor in-licensed from AstraZeneca in October 2016 for a $30.0 million upfront payment, with a phase 2 study in non-CF bronchiectasis expected to begin in 2017, and INS1009, an inhaled treprostinil prodrug nanoparticle formulation for rare pulmonary disorders including PAH. Financially, Insmed had no material revenue in 2016, 2015 or 2014. Net loss was $176.3 million, or $2.85 per share, in 2016, up from $118.2 million in 2015, driven mainly by the $30.0 million AstraZeneca payment and higher clinical trial and compensation costs. Research and development expenses were $122.7 million and general and administrative expenses were $50.7 million. Cash and cash equivalents fell to $162.6 million at December 31, 2016 from $282.9 million, the accumulated deficit reached $765.2 million, and the company stated it has no committed sources of capital. Borrowings under the Hercules A&R Loan Agreement totaled $55.0 million, with a minimum cash liquidity covenant of $25.0 million. Management believes current funds are sufficient for at least the next 12 months. The filing also discloses risks including a securities class action filed July 15, 2016 (Hoey v. Insmed Incorporated), a withdrawn European MAA for ARIKAYCE in June 2016, and a rat carcinogenicity finding that the company notes may affect ARIKAYCE's approvability or labeling.
Feb 23, 2017
2015
Insmed Annual Report, Year Ended Dec 31, 2015
Insmed Incorporated is a global biopharmaceutical company focused on rare diseases. Its lead candidate, ARIKAYCE (liposomal amikacin for inhalation, LAI), is in late-stage development for nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC). The company has no meaningful revenue: it recorded no product revenue in 2015 or 2014, and the only revenue reported in the period was an $11.5 million one-time payment in 2013 from Premacure. The net loss was $118.2 million in 2015 (($2.02) per share), versus $79.2 million in 2014, and the accumulated deficit reached $589.0 million. Cash and cash equivalents were $282.9 million at December 31, 2015, following net proceeds of $222.9 million from an April 2015 offering. Management states that this cash is sufficient to fund operations for at least the next twelve months. The near-term catalysts are regulatory and clinical. The European Medicines Agency's CHMP is reviewing the marketing authorization application for ARIKAYCE, with a 180-day list of outstanding issues expected in the first quarter of 2016 and a CHMP opinion expected around the middle of 2016. The global phase 3 CONVERT study is expected to complete enrollment in the second half of 2016, and the company plans to prepare a US NDA based on its results. The earlier phase 2 (112) study missed its primary endpoint on mycobacterial density (p=0.072) but showed a key secondary endpoint of culture conversion at Day 84 with p=0.003. Management expects research and development and general and administrative expenses to rise in 2016. The filing also highlights risks. Commercial success depends entirely on regulatory approval of ARIKAYCE, and the company has a very small sales organization and limited commercial experience. Manufacturing relies on sole or limited third-party suppliers, including Althea, Therapure and PARI for the nebulizer. The company carries a $25.0 million Hercules loan at 9.25% with covenants restricting debt, liens and dividends.
Feb 25, 2016
2014-A
Insmed Annual Report (Amendment), Year Ended Dec 31, 2014
This Form 10-K/A (Amendment No. 1) for fiscal 2014 from Insmed Incorporated, a Virginia corporation, restates Part III of the original 10-K filed February 27, 2015. The amendment was filed solely to provide governance, executive compensation, beneficial ownership, related-party, and accounting fee information that the original filing had incorporated by reference from the 2015 proxy statement, and to change the cover page's 'Documents Incorporated by Reference' section to 'None.' Financial statements are not included in this amendment, and the filing states that information is as of December 31, 2014. The filing describes Insmed as a biopharmaceutical company focused on ARIKAYCE (liposomal amikacin for inhalation) for nontuberculous mycobacteria (NTM) lung infections and cystic fibrosis patients with Pseudomonas aeruginosa lung infections, and on INS1009, an inhaled treprostinil prodrug. It reports that a Marketing Authorization Application for ARIKAYCE was filed with the European Medicines Agency and validated in February 2015, and that the FDA granted Breakthrough Therapy Designation for ARIKAYCE in NTM lung infections. A 2014 underwritten public offering provided net proceeds of approximately $108.0 million. For governance and compensation, the Board is designated to have up to nine directors, with Donald Hayden, Jr. as Chairman and William H. Lewis as President and CEO. The Audit Committee consists of David W.J. McGirr (Chairman and audit committee financial expert), Steinar J. Engelsen, M.D., and Alfred F. Altomari, all determined to be independent. Shareholders approved say-on-pay with over 98% of votes cast at the 2014 annual meeting, and the next advisory vote is scheduled for 2017. The 2014 corporate bonus payout was 103% of target. Ernst & Young's total fees were $527,274 for 2014 compared with $550,703 for 2013.
Mar 30, 2015
2014
Insmed Annual Report, Year Ended Dec 31, 2014
Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing ARIKAYCE (liposomal amikacin for inhalation) for two orphan indications: nontuberculous mycobacteria (NTM) lung infections and Pseudomonas lung infections in cystic fibrosis (CF) patients, and on INS1009, an inhaled treprostinil prodrug for pulmonary arterial hypertension. The company has no revenue in 2014 and 2012, reported a 2014 net loss of $79.2 million (versus $56.1 million in 2013, which included an $11.5 million one-time payment from Premacure), and had an accumulated deficit of $470.8 million at December 31, 2014. Cash and cash equivalents were $159.2 million at year-end, and the company states it believes it has sufficient funds to meet its financial needs in 2015, though it may raise additional capital. Key regulatory progress includes an EMA Marketing Authorization Application for ARIKAYCE, validated in February 2015 for both NTM and CF indications. The FDA granted Breakthrough Therapy designation for NTM in June 2014, and the company has commenced a global phase 3 confirmatory study (the 212 study) of about 300 patients, with preliminary top-line results expected in mid-2016. The phase 2 NTM trial missed its primary endpoint (p=0.148) but achieved statistical significance on culture conversion (11 of 44 versus 3 of 45 on placebo, p=0.01). The company states that it does not expect ARIKAYCE or other candidates to be commercially available for at least the next year or two, if at all. Investors should weigh the company's dependence on ARIKAYCE, its sole-source manufacturing and nebulizer supply arrangements, its Hercules term loan of $25.0 million at 9.25% with a maturity of January 1, 2016 (extendable to 2018 if certain financing thresholds are met), and risk factors tied to clinical, regulatory and reimbursement outcomes.
Feb 27, 2015
2013
Insmed Annual Report, Year Ended Dec 31, 2013
Insmed Incorporated (Virginia corporation, Nasdaq: INSM) is a biopharmaceutical company developing inhaled therapies for serious lung diseases. Its lead candidate, ARIKAYCE (liposomal amikacin for inhalation, LAI), is in a phase 2 trial for non-tuberculous mycobacteria (NTM) lung infections, with top-line results expected in March 2014, and has completed a phase 3 trial in cystic fibrosis (CF) patients with Pseudomonas lung infections in Europe and Canada, with regulatory filings planned for mid-2014. The company estimates the combined global market for these two orphan indications at approximately $1 billion. The company has no approved products and no material revenue: 2013 revenue was $11.5 million, a one-time payment from Premacure (now Shire plc) for its royalty rights, compared with no revenue in 2012. Financially, net loss attributable to common stockholders was $56.1 million ($1.60 per share) in 2013, up from $41.4 million in 2012, driven mainly by higher research and development expense ($44.3 million vs. $29.8 million) and general and administrative expense ($22.2 million vs. $12.7 million). Cash and cash equivalents were $113.9 million at December 31, 2013, and the company stated it believes it has sufficient funds for 2014, though it may need additional capital. The accumulated deficit was $391.6 million. Debt consisted of $20.0 million of secured notes under a Hercules loan agreement, and the company completed a public offering in July 2013 with net proceeds of $67.0 million. Key risks include dependence on ARIKAYCE's success, sole-source suppliers (Althea for drug product and PARI for the nebulizer), a rat carcinogenicity finding that led to FDA clinical holds in 2011 (lifted in 2012), competition from Novartis's Tobi products in CF, and a pending appraisal action by former Transave stockholders with trial scheduled for April 2014.
Mar 6, 2014
2012
Insmed Annual Report, Year Ended Dec 31, 2012
Insmed Incorporated, a biopharmaceutical company focused on inhaled therapies for serious lung diseases, reported no revenue for 2012 and a net loss of $41.4 million ($1.56 per share), compared with a net loss of $68.8 million ($2.95 per share) in 2011, which included a $26.0 million impairment loss. Its lead candidate, ARIKACE (liposomal amikacin for inhalation), is in a phase 3 trial in cystic fibrosis patients with Pseudomonas lung infections in Europe and Canada, with clinical results expected in mid-2013, and in a phase 2 trial in non-tuberculous mycobacteria (NTM) lung infections, with results expected in Q4 2013. The company cites its own estimate of roughly $1 billion in combined global market potential for the two orphan indications. As of December 31, 2012, cash, cash equivalents and a certificate of deposit totaled $92.9 million, and the company stated it believes it has sufficient funds for 2013, though it has no committed sources of capital beyond that. The filing also flags significant risks. The FDA objected to the ARIKACE trade name in early 2013, and the company has not decided whether to appeal. A rat carcinogenicity finding led to a 2011 clinical hold, since lifted, and a 9-month dog inhalation toxicity study was completed in January 2013 with an unaudited interim report submitted to the FDA. Management concluded 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, after equity awards exceeded per-person sub-limits. The company also faces a possible Nasdaq listing rule violation and shareholder demands related to those grants, and it has a $20.0 million secured loan with Hercules Technology Growth Capital.
Mar 18, 2013
2011
Insmed Annual Report, Year Ended Dec 31, 2011
Insmed Incorporated, a development-stage biopharmaceutical company focused on proprietary liposomal technology for inhalation lung delivery, reported a 2011 net loss of $59.7 million, or $68.8 million attributable to common stockholders ($2.95 per share) after a $9.2 million non-cash beneficial conversion charge. Revenues fell to $4.4 million from $6.9 million, reflecting the end of IPLEX expanded access program cost recovery revenue after IPLEX supplies were exhausted in late 2011. The company's lead product candidate, ARIKACE (liposomal amikacin for inhalation), drove a sharp increase in research and development expense to $27.9 million from $4.8 million, and a $26.0 million non-cash impairment charge was recorded in the third quarter of 2011 after the FDA placed clinical holds on Phase 3 trials for cystic fibrosis and non-tuberculous mycobacteria (NTM) lung infections. As of December 31, 2011, Insmed had $78.3 million in cash and investments and an accumulated deficit of $294.2 million. The company stated it believed it had sufficient funds for 2012 but would likely need additional capital later, and it noted it had no committed sources of capital. In January 2012 the FDA lifted the clinical hold for the NTM indication, and the company planned a Phase 2 NTM trial starting in mid-2012 and a European Phase 3 CF trial starting in the second quarter of 2012. The U.S. CF clinical hold remained in place, and the filing states that the timing of its removal is unknown. The company has no material source of operating revenue, expects operating losses for the foreseeable future, and has deprioritized IPLEX, which it intends to out-license. Investors face significant regulatory uncertainty around ARIKACE, dependence on a sole third-party manufacturer and a single nebulizer supplier, and pending appraisal and breach-of-contract litigation related to the 2010 Transave merger and a former IPLEX trial participant.
Mar 13, 2012
2010
Insmed Annual Report, Year Ended Dec 31, 2010
Insmed Incorporated's 10-K for fiscal 2010 centers on its December 1, 2010 business combination with Transave, Inc., a privately held New Jersey pharmaceutical company focused on inhaled treatments for serious lung infections. Insmed paid off Transave's $7.8 million debt, issued about 25.9 million common shares and about 91.7 million Series B Conditional Convertible Preferred shares, and paid cash consideration of $561,280. Former Transave stockholders hold approximately 47% of the combined company on a fully diluted basis. On March 2, 2011, Insmed completed a one-for-ten reverse stock split, and the preferred shares converted to common stock on March 1, 2011. The company's lead product candidate is ARIKACE (liposomal amikacin for inhalation). Insmed plans to begin Phase 3 patient accrual in the second half of 2011 for cystic fibrosis patients with Pseudomonas lung infections and for patients with non-tuberculous mycobacteria (NTM) lung infections, and it filed an IND for NTM in the first quarter of 2011. Revenue is small and comes mainly from the IPLEX Expanded Access Program in Italy. The filing states that IPLEX supply is expected to be exhausted in about the third quarter of 2011, after which the company expects no material operating revenue unless it executes an income-generating transaction. For 2010, revenues were $6.9 million, the net loss was $6.4 million ($0.49 per share), and cash and investments totaled $110.2 million. The accumulated deficit was $235 million. The filing also flags several risks: the company must regain compliance with the NASDAQ $1.00 minimum bid price by June 13, 2011, or face delisting; it has no committed sources of capital; and it faces pending litigation, including the Cacchillo suit and the Mackinson quasi-appraisal class action, with no estimate of possible loss stated for either.
Mar 16, 2011
2009
Insmed Annual Report, Year Ended Dec 31, 2009
Insmed Incorporated, a Virginia corporation headquartered in Richmond, Virginia, reported in its 10-K for fiscal 2009 that it sold its follow-on biologics (FOB) platform to Merck & Co., Inc. on March 31, 2009 for an aggregate purchase price of $130 million, with net proceeds of approximately $127 million. The sale produced a gain of $127,474 thousand and net income of $118,350 thousand for 2009, the company's only profitable year, compared with a net loss of $15,667 thousand in 2008. Following the sale, the company's focus is its proprietary protein product IPLEX™, which it no longer has the capability to manufacture. The company has ceased supplying IPLEX™ to new patients, has decided not to pursue further clinical trials pending its Strategic Review Process, and has about 51 patients receiving the drug, most under an Expanded Access Program for ALS in Italy that generates cost recovery revenue. The company's financial position at December 31, 2009 included cash, cash equivalents and short-term investments of $122.2 million, plus a $2.1 million certificate of deposit, for total cash and investments of $124.3 million. Total revenues were $10.4 million in 2009, down from $11.7 million in 2008, and the company reported an accumulated deficit of approximately $230 million. The filing states that the company's sufficient IPLEX™ inventory supports existing patients into approximately mid-2011, when its primary source of operating revenue will cease. Thereafter, interest on the sale proceeds is expected to be the primary income source unless the Strategic Review Process produces an income-generating transaction. Leadership and listing matters are also significant. Geoffrey Allan, Ph.D., resigned as President, CEO and Chairman in June 2009, and the company has decided not to hire a new CEO pending the Strategic Review Process. The company had 15 employees at December 31, 2009. Its common stock traded on the Nasdaq Capital Market, and the company regained compliance with the $1.00 minimum bid price requirement, as NASDAQ notified it on March 3, 2010. The filing notes that the company is reviewing options for the use of the sale proceeds, which may include a special dividend.
Mar 16, 2010
2008
Insmed Annual Report, Year Ended Dec 31, 2008
Insmed Incorporated (INSM) is a development stage company with expertise in recombinant protein drug development, headquartered in Richmond, Virginia. On March 31, 2009, the company completed the sale of its follow-on biologics assets to Merck & Co., Inc. for an aggregate purchase price of $130 million, with expected net proceeds of approximately $123 million after fees, taxes and other costs. The sale included Merck assuming the lease of the Boulder, Colorado manufacturing facility and acquiring its equipment. Insmed now focuses on its proprietary protein platform, led by IPLEX™, with primary focus on Myotonic Muscular Dystrophy (MMD) and Amyotrophic Lateral Sclerosis (ALS). The company is also evaluating options for use of the proceeds, including acquisitions, licensing, mergers, share repurchases and a possible distribution to shareholders. Financially, the company reported 2008 total revenues of $11.7 million and a net loss of $15.7 million, or $0.13 per share, compared with a net loss of $20.0 million in 2007. Cash, cash equivalents and short-term investments were $2.4 million at December 31, 2008, down from $16.5 million a year earlier, and the accumulated deficit was $346 million. Stockholders' equity was a deficit of $2.8 million. The company stated that it expects to operate on a cash-neutral basis for the balance of 2009 and that the net sale proceeds will provide sufficient liquidity to continue as a going concern, while it expects significant losses for at least several more years. The filing also highlights material risks, including a Nasdaq Capital Market minimum bid price deficiency with a compliance deadline of July 17, 2009, the Italian Health Authority's payment for IPLEX™ used in the Expanded Access Program, dependence on contract manufacturers after the Boulder facility transfer, and a Consent Judgment and Permanent Injunction arising from the 2007 settlement with Tercica and Genentech. Employees were reduced to 18 as of March 31, 2009 after the asset sale.
Mar 31, 2009
2007-A
Insmed Annual Report (Amendment), Year Ended Dec 31, 2007
Insmed Incorporated, a Virginia corporation headquartered in Richmond, Virginia, filed this Amendment No. 1 to its Form 10-K for the fiscal year ended December 31, 2007, on April 11, 2008. The filing states that it was made solely to update the Exhibits Index. It does not reflect events occurring after the original Form 10-K and does not modify or update the disclosure in that report, except as needed to reflect the exhibit changes. The cover page reports an aggregate market value of $98,583,736 for common equity held by non-affiliates as of June 30, 2007, and 121,904,312 shares of common stock outstanding as of February 28, 2008. The registrant checked the box for accelerated filer and not for large accelerated filer, non-accelerated filer, or small reporting company. Part III information is incorporated by reference from a definitive proxy statement expected to be filed no later than April 29, 2008. The amended exhibit list includes the certifications of Chief Executive Officer Geoffrey Allan, Ph.D. and Chief Financial Officer Kevin P. Tully under Sections 302 and 906 of the Sarbanes-Oxley Act. It also lists material agreements, including a Settlement, License and Development Agreement dated March 6, 2007 among Insmed, Insmed Therapeutic Proteins, Inc., Celtrix Pharmaceuticals, Tercica Inc., and Genentech, Inc., and a License Agreement with Fujisawa Pharmaceutical Co., Ltd. dated January 19, 2004. Portions of certain exhibits are subject to confidential treatment.
Apr 11, 2008
2007
Insmed Annual Report, Year Ended Dec 31, 2007
Insmed Incorporated, a Virginia corporation then referred to in the filing as a development stage company, reports in its 10-K for the year ended December 31, 2007 that it is pursuing a dual path strategy: entering the follow-on biologics market and advancing its proprietary protein platform, centered on IPLEX, into niche markets. Total revenues for 2007 were $7.5 million, up from $991,000 in 2006, driven by Expanded Access Program cost recovery, licensing income and IPLEX sales in the first quarter. The net loss narrowed to $20.0 million, or $0.17 per share, from $56.1 million, or $0.59 per share, as selling, general and administrative expenses fell to $8.5 million from $25.7 million and research and development expenses fell to $18.9 million from $21.1 million. The company's financial position is weak. Cash, cash equivalents and short-term investments were $16.5 million at year-end, which the company believes will fund activities into the fourth quarter of 2008. Ernst & Young's report includes a going concern explanatory paragraph citing recurring losses, negative operating cash flows and dependence on financing. The accumulated deficit was approximately $330.8 million. The company withdrew IPLEX from the U.S. short-stature market under a March 2007 settlement with Tercica and Genentech, and it now focuses on myotonic muscular dystrophy and an Expanded Access Program for ALS in Italy. Investors also face near-term listing and dilution risks. The common stock moved to the Nasdaq Capital Market on February 29, 2008, and the company has until June 12, 2008 to regain compliance with the $1.00 minimum bid price, or a reverse stock split may be required. Convertible notes, warrants and options could dilute existing shareholders, and the company stated it has no committed sources of capital.
Mar 12, 2008
2006
Insmed Annual Report, Year Ended Dec 31, 2006
Insmed Incorporated, a Virginia corporation, reported a 2006 net loss of $56.1 million on revenues of $991 thousand, with an accumulated deficit of $310.8 million and cash, cash equivalents and restricted cash of $24.1 million at December 31, 2006. Ernst & Young's audit report includes a going-concern explanatory paragraph, and management states the existing cash is sufficient to fund activities into the fourth quarter of 2007. The company had been commercializing IPLEX for severe primary IGF-1 deficiency after its December 2005 FDA approval and May 2006 launch, but on March 5, 2007 it settled patent litigation with Tercica and Genentech. Under the settlement, Insmed ceased U.S. sales and marketing of IPLEX, withdrew its European marketing application, and gained a worldwide development partnership to pursue non-short-stature indications, with Tercica and Genentech holding opt-in rights and a 50/50 profit and cost share. Following the settlement, the company restructured: its commercial operations unit is being eliminated, Boulder manufacturing is being scaled back, and the workforce was reduced by approximately 34%, to 100 employees as of March 9, 2007. Management cites annualized savings of $12 million in commercial costs and $10 million in manufacturing costs, a $7.1 million asset impairment recorded in 2006, and about $1.7 million in severance to be recognized in 2007. The remaining pipeline focuses on IPLEX in myotonic muscular dystrophy, HIV-associated adipose redistribution syndrome and retinopathy of prematurity, along with the oncology candidates rhIGFBP-3 and INSM-18. For investors, the central issues are the company's funding needs and the going-concern doubt. As of the filing, the company had no committed sources of capital, and outstanding convertible notes and warrants could convert into about 13.8 million shares, with options adding about 6.6 million more. The company also disclosed a $29 million remaining balance on a $75 million shelf registration.
Mar 16, 2007
2005-A
Insmed Annual Report (Amendment), Year Ended Dec 31, 2005
This Form 10-K/A (Amendment No. 1) from Insmed Incorporated for the fiscal year ended December 31, 2005, was signed March 9, 2006, and filed solely to amend the Exhibit List and add Exhibit 21.1 (Subsidiaries of Insmed Incorporated). The amendment does not contain financial statements, operating results, or business narrative beyond the cover page, signatures, and exhibit index. The registrant is a Virginia corporation headquartered in Glen Allen, Virginia, with Commission File Number 0-30739, and its common stock trades on the Nasdaq National Market. The cover page reports an aggregate market value of $44,188,816 held by non-affiliates as of June 30, 2005, and 77,150,700 shares of common stock outstanding as of February 28, 2006. The registrant checked the box indicating it is a non-accelerated filer. Part III information is incorporated by reference from the definitive proxy statement to be filed for the 2006 Annual Meeting of Shareholders. The exhibit index lists items previously filed and incorporated by reference, including the Rights Agreement, the March 2005 private placement of 5.5% Notes Due 2008-2010 and warrants, a Boulder, Colorado building lease dated March 25, 2004, and a lease with 2545 Central, LLC dated December 14, 2005. Several exhibits, including the Fujisawa license agreement and the lease with 2545 Central, LLC, are subject to confidential treatment requests. Certifications under Sections 302 and 906 of the Sarbanes-Oxley Act are included as Exhibits 31.1, 31.2, 32.1, and 32.2.
Mar 9, 2006
2004-A6
Insmed Annual Report (Amendment), Year Ended Dec 31, 2004
This Form 10-K/A from Insmed Incorporated, a Virginia corporation headquartered in Glen Allen, Virginia, amends the annual report for the fiscal year ended December 31, 2004. The filing was signed on March 9, 2006 by Chairman, President and CEO Geoffrey Allan, Ph.D., and Kevin P. Tully, EVP and Chief Financial Officer. Its stated purpose is solely to correct the inadvertent omission of certain language in Exhibits 31.1 and 31.2, the Section 302 certifications. The filing states that each certification, as corrected, was true and correct as of the date of the original filing of the applicable report. The amendment supplements the original Form 10-K for 2004 and Amendments No. 3 and No. 4, which were filed with the SEC on March 16, 2005, May 13, 2005 and June 10, 2005. The cover page reports an aggregate market value of $86,024,160 for common equity held by non-affiliates as of June 30, 2004, based on the Nasdaq National Market closing price. It also reports 44,986,996 shares of common stock, $.01 par value, outstanding as of February 29, 2005. The filing's exhibit index lists the company's corporate governance documents, its 2000 Stock Purchase and Stock Incentive Plans, a form of change of control agreement for certain executive officers, an officers bonus plan, and several license and development agreements with partners including Taisho, Fujisawa, Pharmacia AB and Avecia. Certain of these exhibits are subject to confidential treatment orders. This filing contains no financial statements or operating results.
Mar 9, 2006
2005
Insmed Annual Report, Year Ended Dec 31, 2005
Insmed Incorporated, a Virginia biopharmaceutical company, reports in its annual report for 2005 that it received FDA approval on December 12, 2005 for IPLEX (mecasermin rinfabate), its once-daily IGF-1 replacement therapy, for growth failure in children with Severe Primary IGFD. The company plans to launch IPLEX commercially in the United States in the second quarter of 2006 with its own specialty sales force targeting about 400 pediatric endocrinologists, and it estimates the full cost of bringing IPLEX to market at $270 million. IPLEX carries seven years of U.S. Orphan Drug exclusivity for Severe Primary IGFD. Its oncology candidates INSM-18 and rhIGFBP-3 remain in Phase I/II and Phase I clinical development. The company reported a 2005 net loss of $40.9 million on revenues of $131 thousand, with an accumulated deficit of $254.7 million at December 31, 2005. Ernst & Young's audit report includes a going concern explanatory paragraph, and management states that existing cash reserves will not sufficiently fund activities through the next twelve months without additional financing. Cash and cash equivalents were $18.8 million at year-end, and the company had $35 million of 5.5% Senior Convertible Notes issued in March 2005. The filing also highlights significant risk. Tercica and Genentech have sued Insmed for patent infringement in the United Kingdom and the United States, and Tercica's competing product Increlex was approved by the FDA in August 2005 for a substantially similar indication. Investors should weigh the commercial launch opportunity against the going concern doubt, the need for substantial additional capital, and the ongoing litigation.
Mar 6, 2006
2004-A5
Insmed Annual Report (Amendment), Year Ended Dec 31, 2004
This filing is Amendment No. 5 to Insmed Incorporated's Annual Report on Form 10-K for the fiscal year ended December 31, 2004, dated March 3, 2006. It does not contain financial statements, business discussion, or operating results. The Explanatory Note states that the amendment is filed solely to correct the inadvertent omission of certain language in Exhibits 31.1 and 31.2, the Section 302 certifications of the Chief Executive Officer, Geoffrey Allan, Ph.D., and the Principal Financial and Accounting Officer, Kevin P. Tully. The filing states that each certification, as corrected, was true and correct as of the date of the original filing of the applicable report. The filing amends the original Form 10-K and Amendments No. 3 and No. 4, which were filed with the SEC on March 16, 2005, May 13, 2005 and June 10, 2005. The registrant is a Virginia corporation headquartered in Glen Allen, Virginia, with common stock quoted on the Nasdaq National Market. The aggregate market value of common equity held by non-affiliates was $86,024,160 as of June 30, 2004, and 44,986,996 shares of common stock were outstanding as of February 29, 2005. The exhibit index lists the financial and operating agreements previously filed with the SEC, including license agreements with Taisho Pharmaceutical, Pharmacia AB and Fujisawa Pharmaceutical, and the November 2004 private placement of common stock and warrants. The filing itself does not contain the substantive financial results or business update for investors; those appear in the original report referenced in the explanatory note.
Mar 6, 2006
2004-A4
Insmed Annual Report (Amendment), Year Ended Dec 31, 2004
Insmed Incorporated (filed as Insmed Incorporated, a Virginia corporation) is a biopharmaceutical company focused on metabolic and endocrine diseases and oncology, with three lead drug candidates: rhIGF-I/rhIGFBP-3 (SomatoKine), rhIGFBP-3, and INSM-18. Its most advanced program is rhIGF-I/rhIGFBP-3 for growth hormone insensitivity syndrome (GHIS). The company submitted a New Drug Application for GHIS on January 3, 2005, which the FDA accepted for review on March 4, 2005, with a User Fee Goal Date of July 3, 2005. The company has no commercial sales, reported a 2004 net loss of $27.2 million, and had an accumulated deficit of $213.7 million at December 31, 2004. Financially, cash and cash equivalents fell to $9.2 million at December 31, 2004 from $29.5 million a year earlier, and stockholders' equity was $7.2 million. Research and development expenses rose to $23.3 million in 2004 from $7.1 million in 2003, reflecting a broader clinical trial program and increased manufacturing activity. In November 2004 the company completed a private placement of 6,455,551 shares at $1.35 per share, raising about $8.0 million net. On March 15, 2005, it sold approximately $35 million of 5.5% convertible notes and warrants, and management states this funding is sufficient to fund operations through the next twelve months. The company faces significant litigation from Tercica, Inc. and Genentech, Inc. over several patents, including suits in the United Kingdom and the Northern District of California. The filing states that an adverse ruling could materially affect the company's business. This Amendment No. 4 revises certain MD&A and Note 1 disclosures from the original 10-K filed March 16, 2005.
Jun 10, 2005
2004-A3
Insmed Annual Report (Amendment), Year Ended Dec 31, 2004
Insmed Incorporated's Amendment No. 3 to its Form 10-K for the fiscal year ended December 31, 2004 amends only Part III (Items 10 through 14: directors, executive compensation, security ownership, related transactions and accountant fees). The filing reproduces the full annual report, which describes Insmed as a biopharmaceutical company developing drugs that modulate IGF-I activity for metabolic and endocrine diseases and oncology. Its lead candidate, rhIGF-I/rhIGFBP-3 (SomatoKine), was the subject of a New Drug Application submitted January 3, 2005 for growth hormone insensitivity syndrome (GHIS), accepted for FDA review on March 4, 2005, with a Phase III trial continuing and a European MAA planned. The company reported no commercial revenue to speak of: revenues were $137 thousand in 2004, research and development expenses were $23.3 million, and the net loss was $27.2 million, bringing the accumulated deficit to $213.7 million. Cash and cash equivalents were $9.2 million at December 31, 2004, and stockholders' equity was $7.2 million. On March 15, 2005, the company sold approximately $35 million of 5.5% convertible notes with warrants, which management says will fund operations for the next twelve months. The filing discloses material risks, including patent infringement suits filed by Tercica, Inc. and Genentech, Inc. in the United Kingdom and the United States, which the company says could materially affect its business if decided adversely, and a competing Tercica NDA for rhIGF-I in severe primary IGF-I deficiency that could raise orphan exclusivity concerns. The company also relies on limited third-party and single-facility manufacturing capacity.
May 13, 2005
2004-A2
Insmed Annual Report (Amendment), Year Ended Dec 31, 2004
Insmed Incorporated filed this Amendment No. 2 to its Annual Report on Form 10-K/A for the fiscal year ended December 31, 2004, dated April 7, 2005. The filing amends the original 10-K, which was filed with the SEC on March 16, 2005. Its stated purpose is limited: to update the Exhibit Index and to file the Company's Officers Bonus Plan as Exhibit 10.20. The registrant is a Virginia corporation headquartered in Glen Allen, Virginia, and its common stock and preferred stock purchase rights are the registered securities. The amendment is signed by Kevin P. Tully, Principal Financial Officer, Treasurer and Controller. The Exhibit Index lists the corporate governance documents, the July 2003 and November 2004 private placement agreements and warrant forms, the stock incentive and purchase plans, and a series of license, development and supply agreements with Celtrix, Elan, University of Virginia, Taisho, Avecia, Pharmacia AB and Fujisawa. It also adds a Form of Change of Control Agreement with certain executive officers and the Officers Bonus Plan. Several agreements are subject to confidential treatment requests, with certain portions omitted and filed separately with the SEC. For investors, this amendment contains no new financial results. Its main substance is the disclosure of executive compensation arrangements (the Change of Control Agreement and Officers Bonus Plan) and an updated list of the agreements and certifications that accompany the annual report.
Apr 7, 2005
2004-A
Insmed Annual Report (Amendment), Year Ended Dec 31, 2004
Insmed Incorporated, a Virginia corporation headquartered in Glen Allen, Virginia, filed this Amendment No. 1 to its Annual Report on Form 10-K/A for the fiscal year ended December 31, 2004. The amendment was dated March 30, 2005, and amends the original Form 10-K filed with the SEC on March 16, 2005. Its stated purpose is narrow: to correct an inadvertent check mark on the cover page indicating that disclosure of delinquent filers under Item 405 of Regulation S-K would not be contained in the definitive proxy statement. The company states that this disclosure will appear in its 2005 proxy statement under the heading "Section 16(a) Beneficial Ownership Reporting Compliance." The cover page provides the company's key market and capital data. The aggregate market value of common equity held by non-affiliates was $86,024,160 as of June 30, 2004, based on the Nasdaq National Market closing price on that date. As of February 29, 2005, there were 44,986,996 shares of common stock, $.01 par value, outstanding. The registrant also reports that it has filed all required Exchange Act reports during the preceding 12 months and is an accelerated filer. Common Stock and Preferred Stock Purchase Rights are registered under Section 12(g) of the Act, and no securities are registered under Section 12(b). This amendment does not contain the company's financial statements, business description, or operating results. Investors seeking those details should refer to the original Form 10-K filed on March 16, 2005. Part III information is incorporated by reference from the company's definitive proxy statement for its 2005 Annual Meeting of Shareholders.
Mar 30, 2005
2004
Insmed Annual Report, Year Ended Dec 31, 2004
Insmed Incorporated, a Virginia biopharmaceutical company focused on metabolic and endocrine diseases and oncology, reports in its annual report for 2004 that it has no commercial product sales yet. Its lead candidate, rhIGF-I/rhIGFBP-3 (SomatoKine), was submitted to the FDA as a New Drug Application on January 3, 2005 for growth hormone insensitivity syndrome (GHIS), and the FDA accepted it for review on March 4, 2005. The company also has rhIGFBP-3 in Phase I and pre-clinical cancer development and INSM-18 planned for clinical trials in 2005. Revenues were $137 thousand in 2004, research and development expenses rose to $23.3 million from $7.1 million, and the net loss was $27.2 million, leaving an accumulated deficit of $213.7 million. Financial condition is weak. Cash and cash equivalents fell to $9.2 million at December 31, 2004 from $29.5 million a year earlier, and total stockholders' equity was $7.2 million. The filing states that on March 15, 2005 the company sold approximately $35 million of 5.5% convertible notes along with warrants for 14,864,883 shares at $1.36 per share, and that this funding should sustain operations for the next twelve months. The filing also states that the company will need substantial additional capital and has no committed sources of funding. The filing highlights significant legal and competitive risk. Tercica, Inc. and Genentech sued Insmed and Avecia over patents, and the filing says an adverse ruling could have a material adverse effect on the business. Tercica has also submitted an NDA for a rhIGF-I product for a related indication, which could affect orphan exclusivity for GHIS. Insmed's 2004 Form 10-K also reports that it has 55 full-time employees and that its Boulder, Colorado manufacturing facility is central to its supply plans.
Mar 16, 2005
2003-A2
Insmed Annual Report (Amendment), Year Ended Dec 31, 2003
This Form 10-K/A (Amendment No. 2) from Insmed Incorporated amends the company's annual report for the fiscal year ended December 31, 2003, which was originally filed with the SEC on March 12, 2004. The amendment is limited in scope. Its stated purpose is to correct the inadvertent exclusion of Exhibit A to the License Agreement dated January 19, 2004, between Insmed and Fujisawa Pharmaceutical Co., Ltd. That agreement was filed as Exhibit 10.18 to the original annual report. The amendment restates Exhibit 10.18 in its entirety and attaches the Section 302 Sarbanes-Oxley certifications from the Chairman and Chief Executive Officer, Geoffrey Allan, Ph.D., and the Treasurer and Controller, Kevin P. Tully. The cover page reports an aggregate market value of $89,308,519 for common equity held by non-affiliates as of June 30, 2003, based on the Nasdaq National Market closing price. It also reports 38,394,994 shares of common stock, $.01 par value, outstanding as of February 29, 2004. The registrant is an accelerated filer and has filed all required reports during the preceding 12 months. Part III information is incorporated by reference from the definitive proxy statement. The amendment states that it has not been updated to reflect events occurring after the original filing. Portions of the license exhibit are subject to a confidential treatment request, and the omitted portions have been filed separately with the SEC.
Sep 23, 2004
2003-A
Insmed Annual Report (Amendment), Year Ended Dec 31, 2003
Insmed Incorporated, a Virginia corporation headquartered in Glen Allen, Virginia, filed this Amendment No. 1 on Form 10-K/A on August 25, 2004, for the fiscal year ended December 31, 2003. The original annual report was filed on March 12, 2004. The amendment is limited in scope. Its stated purpose is to correct the inadvertent exclusion of Exhibit A to the License Agreement dated as of January 19, 2004, between the company and Fujisawa Pharmaceutical Co., Ltd., which was filed as Exhibit 10.18 to the original report. The filing restates Exhibit 10.18 in its entirety and states that it has not been updated for events after the original filing date. The cover page reports an aggregate market value of $89,308,519 held by non-affiliates as of June 30, 2003, based on the Nasdaq National Market closing price, and 38,394,994 shares of common stock outstanding as of February 29, 2004. Part III information is incorporated by reference from the definitive proxy statement.
Aug 25, 2004
2003
Insmed Annual Report, Year Ended Dec 31, 2003
Insmed Incorporated, a Virginia biopharmaceutical company, reports in its Form 10-K for fiscal 2003 that it is focused on developing drugs for metabolic and endocrine diseases and cancer. Its lead candidate, rhIGF-I/rhIGFBP-3 (SomatoKine), is in a Phase III trial for growth hormone insensitivity syndrome (GHIS), and the company plans to file a New Drug Application with the FDA and a Marketing Authorization Application with the EMEA for this indication. Its second candidate, rhIGFBP-3, is in pre-clinical development for cancers including breast, lung, colon and prostate. The company has no commercial product sales and reports no revenue of consequence, with 2003 revenues of $150 thousand. Financially, Insmed reported a 2003 net loss of $10.3 million, or $0.29 per share, down from $36.4 million in 2002, driven mainly by research and development expenses falling to $7.1 million from $18.1 million as clinical trial activity decreased. Cash, cash equivalents and marketable securities were $29.5 million at December 31, 2003, against an accumulated deficit of $186.5 million, and management states that current cash is sufficient to fund operations for the next twelve months. The company raised approximately $13 million in a July 2003 private placement and disclosed that it will need substantial additional funds to continue development and commercialization. The filing also highlights significant risks: dependence on a single contract manufacturer, Avecia Limited, for bulk drug substance; possible FDA requests for broader long-term trials over diabetic retinopathy concerns; potential competition from Tercica, Inc. for orphan exclusivity in GHIS; and a 2003 Nasdaq minimum bid price deficiency that was resolved when the Panel granted continued listing. The company had 20 full-time employees as of December 31, 2003.
Mar 12, 2004
2002
Insmed Annual Report, Year Ended Dec 31, 2002
Insmed Incorporated, a Virginia biopharmaceutical company, filed this Form 10-K for the year ended December 31, 2002 on March 28, 2003. The company develops drug candidates for metabolic and endocrine diseases. Its lead candidate, rhIGF-I/rhIGFBP-3, is being prepared for a pivotal trial in pre-pubertal Laron syndrome patients beginning in the first half of 2003, with a targeted approval for growth hormone insensitivity syndrome in the second half of 2004. Its second candidate, rhIGFBP-3, is in preclinical oncology development, with an IND planned for the second half of 2003. The company has no product revenues and has not received regulatory approval for any product. Financially, the company reported a 2002 net loss of $36.4 million, down from $37.2 million in 2001, and research and development expense of $18.1 million, down from $35.5 million. The decline followed the September 2002 discontinuation of the INS-1 program and Taisho's termination of its joint development agreement. The company also recorded a $2.5 million restructuring charge, a $15.4 million goodwill impairment charge, and 2002 revenues of $1.955 million. Cash and cash equivalents were $27.3 million at year-end, against an accumulated deficit of $176.2 million, and management states this cash will fund operations through 2004. Investors should note the stock listing risk: on January 22, 2003, Nasdaq issued a staff determination for failure to meet the $1.00 minimum bid price. A hearing was held March 6, 2003, and the delisting action was stayed pending the Panel's decision. The last reported sale price on February 28, 2003 was $0.49 per share.
Mar 28, 2003
2000
Insmed Annual Report, Year Ended Dec 31, 2000
Insmed Incorporated (filed as Insmed Incorporated, a Virginia corporation, Nasdaq: INSM) is a pharmaceutical company developing products for metabolic and endocrine diseases associated with insulin resistance. Its lead candidate, INS-1, an orally active insulin sensitizer, is in Phase II trials for type 2 diabetes and polycystic ovary syndrome (PCOS). Its second candidate, SomatoKine, a recombinant IGF-1/BP3 complex, is in Phase II development for type 1 and type 2 diabetes. The company has no approved products and no product sales; its only 2000 revenue was $60 thousand. Financially, the company reported a 2000 net loss of $79.9 million ($79,862 thousand), driven mainly by a one-time $50.4 million non-cash charge for purchased research and development from the May 2000 acquisition of Celtrix Pharmaceuticals, plus $21.6 million in research and development expense and $6.0 million in general and administrative expense. The accumulated deficit reached $102.6 million. Cash, cash equivalents and marketable securities were $83.1 million at year-end, and the company states this is sufficient to fund operations until at least the end of 2002. Equity financings in 2000 produced net proceeds of $97.3 million. The filing also highlights significant risks: the company has no internal manufacturing or marketing capability, relies on contract manufacturers, faces a patent dispute risk with Genentech and others regarding SomatoKine, and depends on its collaboration with Taisho Pharmaceutical for INS-1 in Asia. The company had 40 full-time employees at year-end 2000.
Mar 22, 2001