Insmed Reports Third-Quarter 2024 Financial Results and Provides Business Update
Insmed (INSM) reported Q3 2024 financial results with ARIKAYCE revenue of $93.4 million, showing 18% growth year-over-year. The company maintained its 2024 global ARIKAYCE revenue guidance of $340-360 million. The quarter ended with approximately $1.5 billion in cash and equivalents. Key developments include the planned NDA submission for Brensocatib in Q4 2024 with potential U.S. launch in mid-2025, and a renegotiated term loan providing an additional $150 million. The company reported a net loss of $220.5 million ($1.27 per share) compared to $158.9 million ($1.11 per share) in Q3 2023.
Insmed (INSM) ha riportato i risultati finanziari del terzo trimestre 2024 con un fatturato di ARIKAYCE di 93,4 milioni di dollari, mostrando una crescita del 18% rispetto all'anno precedente. L'azienda ha mantenuto la sua previsione di fatturato globale per ARIKAYCE nel 2024 tra 340-360 milioni di dollari. Il trimestre si è concluso con circa 1,5 miliardi di dollari in contante e equivalenti. Sviluppi chiave includono la pianificata presentazione della NDA per Brensocatib nel quarto trimestre del 2024 con un lancio potenziale negli Stati Uniti a metà 2025, e un prestito rinegoziato che fornisce ulteriori 150 milioni di dollari. L'azienda ha registrato una perdita netta di 220,5 milioni di dollari (1,27 dollari per azione) rispetto ai 158,9 milioni di dollari (1,11 dollari per azione) del terzo trimestre 2023.
Insmed (INSM) reportó los resultados financieros del tercer trimestre de 2024, con ingresos de ARIKAYCE de 93,4 millones de dólares, mostrando un crecimiento del 18% año tras año. La empresa mantuvo su guía de ingresos globales de ARIKAYCE para 2024 de 340-360 millones de dólares. El trimestre finalizó con aproximadamente 1,5 mil millones de dólares en efectivo y equivalentes. Los desarrollos clave incluyen la presentación planeada de la NDA para Brensocatib en el cuarto trimestre de 2024, con un lanzamiento potencial en EE. UU. a mediados de 2025, y un préstamo renegociado que proporciona 150 millones de dólares adicionales. La empresa reportó una pérdida neta de 220,5 millones de dólares (1,27 dólares por acción) en comparación con 158,9 millones de dólares (1,11 dólares por acción) en el tercer trimestre de 2023.
Insmed (INSM)은 2024년 3분기 재무 결과를 발표하며 ARIKAYCE 매출이 9340만 달러에 달하며 올해 대비 18% 증가했다고 밝혔습니다. 회사는 2024년 ARIKAYCE의 글로벌 매출 가이던스를 3억 4천만 달러에서 3억 6천만 달러 사이로 유지했습니다. 이번 분기는 약 15억 달러의 현금 및 현금성 자산으로 마감되었습니다. 주요 개발 사항으로는 2024년 4분기 Brensocatib에 대한 NDA 제출이 예정되어 있으며, 2025년 중반에 미국 출시 가능성이 있음을 포함하며, 추가로 1억 5천만 달러를 제공하는 재협상된 대출이 있습니다. 회사는 2023년 3분기 1주당 1.11달러의 손실에 비해 2억 2천 5백만 달러의 순손실 (1.27달러/주)을 기록했습니다.
Insmed (INSM) a annoncé les résultats financiers du troisième trimestre 2024, avec un chiffre d'affaires d'ARIKAYCE de 93,4 millions de dollars, affichant une croissance de 18 % par rapport à l'année précédente. L'entreprise a maintenu ses prévisions de chiffre d'affaires mondial d'ARIKAYCE pour 2024 entre 340 et 360 millions de dollars. Le trimestre s'est terminé avec environ 1,5 milliard de dollars en liquidités et équivalents. Les développements clés incluent la soumission prévue du NDA pour Brensocatib au quatrième trimestre de 2024, avec un lancement potentiel aux États-Unis à la mi-2025, et un prêt révisé fournissant 150 millions de dollars supplémentaires. L'entreprise a signalé une perte nette de 220,5 millions de dollars (1,27 dollar par action), contre 158,9 millions de dollars (1,11 dollar par action) au troisième trimestre 2023.
Insmed (INSM) hat die finanziellen Ergebnisse für das 3. Quartal 2024 veröffentlicht, mit einem Umsatz von ARIKAYCE in Höhe von 93,4 Millionen Dollar, was einem Wachstum von 18 % im Jahresvergleich entspricht. Das Unternehmen hielt seine Prognose für den globalen Umsatz von ARIKAYCE für 2024 bei 340-360 Millionen Dollar. Das Quartal endete mit etwa 1,5 Milliarden Dollar in bar und Baräquivalenten. Wichtige Entwicklungen umfassen die geplante Einreichung des NDA für Brensocatib im 4. Quartal 2024 mit einem möglichen Markteintritt in den USA Mitte 2025 und ein neu verhandelter Kredit, der zusätzlich 150 Millionen Dollar bereitstellt. Das Unternehmen berichtete über einen Nettoverlust von 220,5 Millionen Dollar (1,27 Dollar pro Aktie) im Vergleich zu 158,9 Millionen Dollar (1,11 Dollar pro Aktie) im 3. Quartal 2023.
- ARIKAYCE revenue grew 18% YoY to $93.4M with double-digit growth across all regions
- Strong cash position of $1.5B in cash and equivalents
- Secured additional $150M through renegotiated term loan with improved terms
- On track for Brensocatib NDA submission in Q4 2024
- Net loss increased to $220.5M from $158.9M YoY
- R&D expenses increased 38% YoY to $150.8M
- SG&A expenses rose 31% YoY to $118.9M
Insights
The Q3 results show strong performance with
However, operating losses widened to
The pipeline progress is particularly encouraging. Brensocatib's NDA submission remains on track for Q4 2024, with potential launch in mid-2025. The ASPEN study subpopulation data showed favorable outcomes across multiple patient groups. The ENCORE study for ARIKAYCE has exceeded its 400-patient target, strengthening the potential for label expansion.
The company's three-pillar commercial strategy is well-executed, with ARIKAYCE growth funding development of brensocatib and TPIP. The PAH study is
—ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of
—NDA Submission for Brensocatib in Bronchiectasis Remains on Track for the Fourth Quarter of 2024 with Potential
—Expanded
—Ends the Third Quarter with
—Renegotiates Term Loan with Pharmakon Resulting in a Lower Cost of Capital and an Additional
—Reiterates 2024 Global ARIKAYCE Revenue Guidance in the Range of
"I am pleased with the progress the Company is making across multiple ongoing initiatives this quarter." said Will Lewis, Chair and Chief Executive Officer of Insmed. "We remain on track to file our NDA for brensocatib in the fourth quarter of 2024 and continue to expect a potential
Recent Pillar Highlights
Pillar 1: ARIKAYCE
- ARIKAYCE global revenue grew
18% in the third quarter of 2024 compared to the third quarter of 2023, reflecting an all-time revenue high and double-digit year-over-year growth in theU.S. ,Japan , andEurope and rest of world. - Insmed has closed screening of new patients for the ENCORE study and is now expected to exceed its target enrollment of 400 patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung infection who have not started antibiotics.
- The Company is scheduled to meet with the
U.S. Food and Drug Administration (FDA) during the fourth quarter to discuss the possibility of an accelerated approval to expand the label for ARIKAYCE to include all patients with MAC lung infection, based on the positive Phase 3 ARISE trial data. Insmed continues to expect that the full data from the ongoing ENCORE trial will be required for approval.
Pillar 2: Brensocatib
- Insmed remains on track to file a New Drug Application (NDA) with the FDA for brensocatib in patients with bronchiectasis in the fourth quarter of 2024. If priority review is granted and brensocatib is approved, Insmed anticipates a
U.S. launch in mid-2025. Launches inEurope andJapan are expected in the first half of 2026, pending approvals. - New subpopulation data from 19 pre-specified categories of patients in the
ASPEN study were presented in October 2024 at the American College of Chest Physicians Annual Meeting inBoston . The annualized rate of pulmonary exacerbations favored brensocatib at both the 10 mg and 25 mg doses over placebo for almost all subgroups. In a separate analysis, least squares mean difference for brensocatib 25 mg demonstrated a reduced decline in post-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52 versus placebo for all prespecified subgroups. - Insmed is advancing launch readiness activities in the
U.S. and has hired, trained, and deployed 120 additional therapeutic sales specialists in advance of launch, focused on bronchiectasis disease-state awareness with an expanded group of pulmonologists while also supporting the growth of ARIKAYCE. - The Company continues to enroll patients in the Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) and anticipates providing top-line data from the study in the second half of 2025.
- The Company is preparing to activate the first
U.S. clinical site for its Phase 2 study of brensocatib in patients with hidradenitis suppurativa (HS) by the end of 2024.
Pillar 3: TPIP
- Enrollment remains ongoing in the Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH), with more than
90% of the target enrollment currently complete. - Insmed remains on track to report topline results from the PAH study in the second half of 2025.
- The Company continues to anticipate initiating a Phase 3 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the second half of 2025.
Pillar 4: Early-Stage Research
- Insmed's early-stage research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies.
- The Company continues to anticipate the totality of its early-stage research programs will comprise less than
20% of overall spend.
Corporate Updates
- Insmed has taken the following actions intended to further strengthen its balance sheet and financial position:
(i) During the third quarter of 2024, the Company completed the redemption of its
(ii) The Company raised an additional
(iii) In October 2024, Insmed entered into an agreement to amend its
- In October 2024, Insmed announced that it has earned the No. 1 ranking in Science's 2024 Top Employers Survey, marking the fourth consecutive year in which Insmed achieved the top ranking. The annual survey polls employees in biotechnology, pharmaceutical, and related industries to determine the 20 best employers, as well as their driving characteristics.
Third-Quarter 2024 Financial Results
- Total revenue for the quarter ended September 30, 2024, was
, reflecting$93.4 million 18% year-over-year growth compared to total revenue of for the third quarter of 2023.$79.1 million - Total revenue for third-quarter 2024 included ARIKAYCE net sales of
in the$66.9 million U.S. , in$21.0 million Japan , and in$5.6 million Europe and rest of world. Third-quarter 2024 sales demonstrated year-over-year growth of13% in theU.S. ,31% inJapan , and45% inEurope and rest of world, reflecting continued growth trends for ARIKAYCE in these regions. - Cost of product revenues (excluding amortization of intangibles) was
for the third quarter of 2024, compared to$21.2 million for the third quarter of 2023, primarily reflecting increased sales volumes of ARIKAYCE.$16.7 million - Research and development (R&D) expenses were
for the third quarter of 2024, compared to$150.8 million for the third quarter of 2023. The year-over-year increase in R&D expenses was primarily driven by increases in manufacturing and compensation and benefit-related expenses.$109.1 million - Selling, general and administrative (SG&A) expenses for the third quarter of 2024 were
, compared to$118.9 million for the third quarter of 2023. The year-over-year increase in SG&A expenses resulted primarily from increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount associated with launch readiness activities for brensocatib.$90.6 million - For the third quarter of 2024, Insmed reported a net loss of
, or$220.5 million per share, compared to a net loss of$1.27 , or$158.9 million per share, for the third quarter of 2023.$1.11
Balance Sheet, Financial Guidance, and Planned Investments
- As of September 30, 2024, Insmed had cash, cash equivalents, and marketable securities totaling
.$1,467.9 million - Insmed is reiterating its guidance for full-year 2024 global ARIKAYCE revenues in the range of
to$340 million , representing$360 million 15% year-over-year growth at the midpoint compared to 2023. - Insmed continues to anticipate that over
80% of total expenditures will be on its clinical and commercial programs, and that less than20% of overall spend will be on its early-stage research programs, reflecting the Company's historical approach to spending. - The Company plans to continue to invest in the following key activities in 2024:
(i) commercialization and continued growth of ARIKAYCE in its current indication globally, as well as advancement of the clinical trial program intended to potentially support label expansion to include all patients with a MAC lung infection and to satisfy the post-marketing requirement for full approval of its current indication;
(ii) advancement of brensocatib, including:
a. activities related to regulatory filing and commercial launch readiness for bronchiectasis and
b. the ongoing Phase 2 BiRCh trial in patients with CRSsNP and the anticipated Phase 2 program in HS;
(iii) advancement of its clinical development programs for TPIP; and
(iv) development of its early-stage research programs.
Conference Call
Insmed will host a conference call beginning today at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (
A replay of the conference call will be accessible approximately 1 hour after its completion through November 7, 2024, by dialing (800) 770-2030 (
INSMED INCORPORATED | ||||||||
Consolidated Statements of Net Loss | ||||||||
(in thousands, except per share data) | ||||||||
(unaudited) | ||||||||
Three Months Ended | Nine Months Ended September | |||||||
2024 | 2023 | 2024 | 2023 | |||||
Product revenues, net | $ 93,425 | $ 79,072 | $ 259,265 | $ 221,515 | ||||
Operating expenses: | ||||||||
Cost of product revenues (excluding amortization of intangible assets) | 21,170 | 16,706 | 59,591 | 47,130 | ||||
Research and development | 150,809 | 109,148 | 418,640 | 433,982 | ||||
Selling, general and administrative | 118,930 | 90,626 | 318,601 | 254,971 | ||||
Amortization of intangible assets | 1,263 | 1,263 | 3,789 | 3,789 | ||||
Change in fair value of deferred and contingent consideration liabilities | 14,682 | 8,997 | 106,482 | 12,997 | ||||
Total operating expenses | 306,854 | 226,740 | 907,103 | 752,869 | ||||
Operating loss | (213,429) | (147,668) | (647,838) | (531,354) | ||||
Investment income | 16,982 | 10,583 | 36,050 | 32,279 | ||||
Interest expense | (21,054) | (20,288) | (63,363) | (60,910) | ||||
Change in fair value of interest rate swap | (3,852) | (1,301) | (1,106) | (1,650) | ||||
Other income (expense), net | 1,843 | 285 | 474 | (314) | ||||
Loss before income taxes | (219,510) | (158,389) | (675,783) | (561,949) | ||||
Provision for income taxes | 1,014 | 544 | 2,441 | 1,557 | ||||
Net loss | $ (220,524) | $ (158,933) | $ (678,224) | $ (563,506) | ||||
Basic and diluted net loss per share | $ (1.27) | $ (1.11) | $ (4.27) | $ (4.06) | ||||
Weighted average basic and diluted common shares outstanding | 173,721 | 142,899 | 159,013 | 138,960 |
INSMED INCORPORATED | ||||
Consolidated Balance Sheets | ||||
(in thousands, except par value and share data) | ||||
As of | As of | |||
September 30, 2024 | December 31, 2023 | |||
(unaudited) | ||||
Assets | ||||
Current assets: | ||||
Cash and cash equivalents | $ 461,451 | $ 482,374 | ||
Marketable securities | 1,006,457 | 298,073 | ||
Accounts receivable | 42,317 | 41,189 | ||
Inventory | 98,470 | 83,248 | ||
Prepaid expenses and other current assets | 41,150 | 24,179 | ||
Total current assets | 1,649,845 | 929,063 | ||
Fixed assets, net | 75,265 | 65,384 | ||
Finance lease right-of-use assets | 18,951 | 20,985 | ||
Operating lease right-of-use assets | 16,030 | 18,017 | ||
Intangibles, net | 59,915 | 63,704 | ||
Goodwill | 136,110 | 136,110 | ||
Other assets | 96,856 | 96,574 | ||
Total assets | $ 2,052,972 | $ 1,329,837 | ||
Liabilities and shareholders' equity | ||||
Current liabilities: | ||||
Accounts payable and accrued liabilities | $ 248,684 | $ 214,987 | ||
Finance lease liabilities | 2,871 | 2,610 | ||
Operating lease liabilities | 7,633 | 8,032 | ||
Total current liabilities | 259,188 | 225,629 | ||
Debt, long-term | 954,831 | 1,155,313 | ||
Royalty financing agreement | 160,049 | 155,034 | ||
Contingent consideration | 157,600 | 84,600 | ||
Finance lease liabilities, long-term | 24,841 | 27,026 | ||
Operating lease liabilities, long-term | 9,692 | 11,013 | ||
Other long-term liabilities | 3,356 | 3,145 | ||
Total liabilities | 1,569,557 | 1,661,760 | ||
Shareholders' equity: | ||||
Common stock, | ||||
shares, 178,846,991 and 147,977,960 issued and outstanding | 1,788 | 1,480 | ||
Additional paid-in capital | 4,605,449 | 3,113,487 | ||
Accumulated deficit | (4,124,369) | (3,446,145) | ||
Accumulated other comprehensive income (loss) | 547 | (745) | ||
Total shareholders' equity (deficit) | 483,415 | (331,923) | ||
Total liabilities and shareholders' equity (deficit) | $ 2,052,972 | $ 1,329,837 |
About ARIKAYCE
ARIKAYCE is approved in the United States as ARIKAYCE® (amikacin liposome inhalation suspension), in
About PARI Pharma and the Lamira® Nebulizer System
ARIKAYCE is delivered by a novel inhalation device, the Lamira® Nebulizer System, developed by PARI. Lamira® is a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care.
About Brensocatib
Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis, CRSsNP, and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any indication in any jurisdiction.
About TPIP
Treprostinil palmitil inhalation powder (TPIP) is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated for the treatment of patients with PAH, PH-ILD, and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction.
IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS |
ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases. |
Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (
Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (
Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (
Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (
Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures.
Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (
Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE.
Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions.
Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus.
Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥
Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.
Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.
LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitation of Use: ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED.
Please see Full Prescribing Information.
About Insmed
Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including a therapy approved in
Headquartered in
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.
The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE, our only approved product, in the
The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 and any subsequent Company filings with the Securities and Exchange Commission (SEC).
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Contact:
Investors:
Bryan Dunn
Executive Director, Investor Relations
(646) 812-4030
bryan.dunn@insmed.com
Michael V. Morabito, Ph.D.
Director, Investor Relations
(917) 936-8430
michael.morabito@insmed.com
Gianna De Palma
Manager, Investor Relations
(873) 886-2236
gianna.depalma@insmed.com
Media:
Mandy Fahey
Vice President, Corporate Communications
(732) 718-3621
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated
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