Insmed Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Business Update
- Insmed's ARIKAYCE revenue for Q4 2023 was $83.7 million, reflecting 24% annual growth. Full-year 2023 revenue reached $305.2 million, exceeding the upper end of guidance.
- The company ended 2023 with $780 million in cash, cash equivalents, and marketable securities, providing runway beyond the expected ASPEN trial readout.
- Insmed reiterates its 2024 sales guidance for global ARIKAYCE revenues in the range of $340-360 million, reflecting double-digit growth compared to 2023.
- Topline data from the Phase 3 ASPEN trial of brensocatib in patients with bronchiectasis is expected in the latter part of the second quarter of 2024.
- The company's early-stage research programs include over 30 pre-clinical programs with the potential to become first-in-class or best-in-class therapies, comprising less than 20% of overall annual spend.
- None.
Insights
The reported growth in ARIKAYCE revenues, which surpassed the company's own guidance for 2023, indicates a robust commercial performance. This 24% annual growth rate, particularly in key markets such as the U.S. and Japan, is a positive sign for investors, as it suggests strong market acceptance and potential for further penetration. Moreover, the reiteration of the sales guidance for 2024, projecting double-digit growth, demonstrates management's confidence in the continued demand for ARIKAYCE. However, the significant increase in R&D and SG&A expenses, which outpaced revenue growth, led to a wider net loss for the year. This raises questions about the sustainability of the current spend rate and the importance of upcoming clinical trial results to justify these investments.
The anticipation of topline data from the Phase 3 ASPEN trial of brensocatib is critical for Insmed's pipeline. Brensocatib's potential in treating non-cystic fibrosis bronchiectasis could address a significant unmet medical need, potentially opening a new market for the company. The lack of safety concerns from the Data Safety Monitoring Committee is reassuring. Furthermore, the completion of enrollment for the Phase 2 TPIP study in PH-ILD ahead of schedule, with topline data expected in Q2 2024, could accelerate the development timeline if results are positive. The clinical progress and strategic prioritization of pipeline candidates underscore the company's commitment to expanding its portfolio beyond ARIKAYCE.
Insmed's strategic decision to allocate over 80% of total annual expenditures to its mid- to late-stage and commercial programs reflects a focused investment approach geared towards driving growth through its existing and pipeline products. The cash reserves of $780 million provide a sufficient runway to support these initiatives beyond the expected ASPEN readout. However, the market will be closely monitoring the outcomes of the pivotal trials, as they are likely to have a significant impact on the company's valuation and future investment prospects. The market dynamics of the therapeutic areas Insmed is targeting, such as bronchiectasis and PH-ILD and the competitive landscape will also play a crucial role in determining the potential commercial success of these pipeline products.
—Topline Data from the Phase 3 ASPEN Trial of Brensocatib in Adult Patients with Bronchiectasis Remain on Track to Read Out in the Latter Part of Second-Quarter 2024—
—Enrollment in the Phase 2 Study of TPIP in Patients with PH-ILD Completed in November 2023; Topline Data Expected in Second-Quarter 2024 Ahead of the
—Company Ends 2023 With
— ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of
—Company Reiterates Sales Guidance for 2024 Global ARIKAYCE Revenues in the Range of
"Insmed continued to deliver strong performance in 2023, demonstrating commercial success evidenced by ARIKAYCE revenues that exceeded the upper end of our 2023 sales guidance range," said Will Lewis, Chair and Chief Executive Officer of Insmed. "The positive ARISE data announced in September 2023, followed by encouraging blinded TPIP data shortly thereafter, marked the beginning of a transformative period of clinical catalysts for the Company. This series of meaningful data readouts from our mid- to late-stage pipeline is expected to continue uninterrupted in the months ahead, with topline results from the PH-ILD and
Recent Pillar Highlights
Pillar 1: ARIKAYCE
- ARIKAYCE global revenue grew
24% in 2023 compared to 2022, reflecting continued strong growth in theU.S. ,Japan , andEurope . - Insmed received encouraging written feedback in December 2023 from the
U.S. Food and Drug Administration (FDA) on the patient-reported outcome data produced in the Phase 3 ARISE study. The Company expects to meet with the FDA in the coming months to gain additional insights and guidance, from which it will finalize its statistical plan for the Phase 3 ENCORE study. - As previously communicated in January 2024, the Company achieved its original target enrollment goal of 250 patients in the ENCORE trial in patients with newly diagnosed or recurrent nontuberculous mycobacterial lung infection caused by Mycobacterium avium complex (MAC) who had not started antibiotics. Enrollment in the trial remains open.
- The Data Safety Monitoring Committee for the ENCORE study held its third safety review meeting in November 2023 and recommended that the study continue as planned.
- Consistent with the Company's expectations, the Pharmaceuticals and Medical Devices Agency (PMDA) in
Japan recently confirmed that it would not consider a label expansion for ARIKAYCE based on data from the ARISE study alone due to (i) the lack of Japanese subjects in that study; (ii) the absence of what PMDA considers a sufficiently long treatment exposure (12 months); and (iii) the absence of resulting evidence of culture conversion the PMDA considers durable (15 months). The ongoing ENCORE trial is designed to satisfy the PMDA's remaining regulatory requirements, including the enrollment of Japanese patients, sufficient treatment exposure, and an endpoint for durable culture conversion. - The Company continues to expect topline data for ENCORE in 2025.
Pillar 2: Brensocatib
- Insmed continues to expect topline data from the Phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis in the latter part of the second quarter of 2024.
- If
ASPEN is successful and regulatory approval is obtained, the Company anticipates a launch in bronchiectasis in theU.S. in mid-2025, followed by launches inEurope andJapan in the first half of 2026. Insmed continues to advance its launch readiness activities in preparation for these potential launches. - The Data Safety Monitoring Committee for the
ASPEN study held its fifth and final meeting in November 2023. No safety signals were identified, and the Committee recommended that the trial continue as planned. - The Company is currently enrolling patients in the Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP).
- The Company expects to initiate a Phase 2 study of brensocatib in patients with hidradenitis suppurativa (HS) in the second half of 2024, pending positive results from the
ASPEN study.
Pillar 3: TPIP
- In October 2023, Insmed announced encouraging blended and blinded data from two ongoing Phase 2 studies of treprostinil palmitil inhalation powder (TPIP) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).
- The Company completed enrollment of 39 patients in the Phase 2 safety study in PH-ILD in November 2023, exceeding its initial enrollment target of 32 patients. Topline data from the study are anticipated in advance of Phase 3 ASPEN data in the second quarter of 2024.
- Enrollment remains ongoing in the Phase 2 study in PAH. Insmed anticipates sharing updated blinded data from approximately 40 patients in the PAH study at the same time topline results from the PH-ILD study become available in the second quarter of 2024. Topline results from the Phase 2 PAH study continue to be expected in 2025.
- Insmed has submitted a protocol amendment to the FDA and other regulatory authorities for the open-label extension of the Phase 2 PAH study. This amendment, if approved, would allow investigators to continue to increase the dose of TPIP up to a maximum of 1,280 micrograms once daily.
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 annual spend.
Fourth-Quarter and Full-Year 2023 Financial Results
- Total revenue for the fourth quarter ended December 31, 2023, was
, reflecting$83.7 million 41% growth compared to total revenue of for the fourth quarter of 2022. Total revenue for the full-year 2023 was$59.3 million , compared to total revenue of$305.2 million for the full-year 2022, reflecting$245.4 million 24% year-over-year growth. - Total revenue for the full-year 2023 was comprised of ARIKAYCE net sales of
in the$224.2 million U.S. , in$65.7 million Japan , and in$15.3 million Europe and rest of world. Full-year 2023 sales demonstrated year-over-year growth of21% in theU.S. and16% inJapan , reflecting continued strong growth trends for ARIKAYCE in these regions. - Cost of product revenues (excluding amortization of intangibles) was
for the fourth quarter of 2023, compared to$18.4 million for the fourth quarter of 2022, primarily reflecting the increase in sales volumes. For the full-year 2023, cost of product revenues (excluding amortization of intangibles) was$13.1 million compared to$65.6 million for the full-year 2022.$55.1 million - Research and development (R&D) expenses were
for the fourth quarter of 2023, compared to$137.0 million for the fourth quarter of 2022. For the full-year 2023, R&D expenses were$124.8 million compared to$571.0 million in 2022, reflecting one-time, non-cash asset acquisition costs and the continued investment in Insmed's early and mid- to late-stage pipeline programs, including increases in headcount to support those existing and acquired programs.$397.5 million - Selling, general and administrative (SG&A) expenses for the fourth quarter of 2023 were
, compared to$89.5 million for the fourth quarter of 2022. For the full-year 2023, SG&A expenses were$73.5 million , compared to$344.5 million for the full-year 2022. The year-over-year increase in SG&A expenses resulted primarily from commercial readiness activities for brensocatib and an increase in headcount.$265.8 million - For the fourth-quarter 2023, Insmed reported a net loss of
, or$186.1 million per share, compared to a net loss of$1.28 , or$160.1 million per share, for the fourth-quarter 2022. For the full-year 2023, Insmed reported a net loss of$1.21 , or$749.6 million per share, compared to a net loss of$5.34 , or$481.5 million per share, for the full-year 2022.$3.91
Balance Sheet, Financial Guidance, and Planned Investments
- As of December 31, 2023, Insmed had cash, cash equivalents, and marketable securities totaling
.$780.4 million - Insmed is reiterating its sales 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 annual expenditures will be on its mid- to late-stage and commercial programs (ARIKAYCE, brensocatib, and TPIP), 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 expansion of ARIKAYCE globally;
(ii) advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis, and commercial launch readiness activities, the ongoing Phase 2 trial in patients with CRSsNP, and the Phase 2 program in HS to be initiated in the second half of the year if the
(iii) advancement of the clinical trial program for ARIKAYCE, which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung infection;
(iv) advancement of its Phase 2 clinical development programs for TPIP; and
(v) development of its early-stage research programs.
Conference Call
Insmed will host a conference call beginning today at 8:30 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 March 23, 2024, by dialing (800) 770-2030 (
INSMED INCORPORATED | ||||||||
Consolidated Statements of Net Loss | ||||||||
(in thousands, except per share data) | ||||||||
(unaudited) | ||||||||
Three Months Ended | Twelve Months Ended | |||||||
2023 | 2022 | 2023 | 2022 | |||||
Product revenues, net | $ 83,693 | $ 59,300 | $ 305,208 | $ 245,358 | ||||
Operating expenses: | ||||||||
Cost of product revenues (excluding amortization of intangible assets) | 18,443 | 13,069 | 65,573 | 55,126 | ||||
Research and development | 137,029 | 124,763 | 571,011 | 397,518 | ||||
Selling, general and administrative | 89,530 | 73,479 | 344,501 | 265,784 | ||||
Amortization of intangible assets | 1,263 | 1,264 | 5,052 | 5,053 | ||||
Change in fair value of deferred and contingent consideration liabilities | 15,700 | (1,800) | 28,697 | (20,802) | ||||
Total operating expenses | 261,965 | 210,775 | 1,014,834 | 702,679 | ||||
Operating loss | (178,272) | (151,475) | (709,626) | (457,321) | ||||
Investment income | 9,853 | 8,318 | 42,132 | 11,081 | ||||
Interest expense | (20,784) | (16,445) | (81,694) | (26,446) | ||||
Change in fair value of interest rate swap | 1,970 | (1,526) | 320 | (1,526) | ||||
Other income (expense), net | 2,170 | 1,130 | 1,856 | (5,939) | ||||
Loss before income taxes | (185,063) | (159,998) | (747,012) | (480,151) | ||||
Provision for income taxes | 998 | 125 | 2,555 | 1,383 | ||||
Net loss | $ (186,061) | $ (160,123) | $ (749,567) | $ (481,534) | ||||
Basic and diluted net loss per share | $ (1.28) | $ (1.21) | $ (5.34) | $ (3.91) | ||||
Weighted average basic and diluted common shares outstanding | 144,806 | 132,694 | 140,433 | 123,035 | ||||
INSMED INCORPORATED | ||||
Consolidated Balance Sheets | ||||
(in thousands, except par value and share data) | ||||
As of | As of | |||
December 31, 2023 | December 31, 2022 | |||
Assets | ||||
Current assets: | ||||
Cash and cash equivalents | $ 482,374 | $ 1,074,036 | ||
Marketable securities | 298,073 | 74,244 | ||
Accounts receivable | 41,189 | 29,713 | ||
Inventory | 83,248 | 69,922 | ||
Prepaid expenses and other current assets | 24,179 | 25,468 | ||
Total current assets | 929,063 | 1,273,383 | ||
Fixed assets, net | 65,384 | 56,491 | ||
Finance lease right-of-use assets | 20,985 | 23,697 | ||
Operating lease right-of-use assets | 18,017 | 21,894 | ||
Intangibles, net | 63,704 | 68,756 | ||
Goodwill | 136,110 | 136,110 | ||
Other assets | 96,574 | 76,104 | ||
Total assets | $ 1,329,837 | $ 1,656,435 | ||
Liabilities and shareholders' equity | ||||
Current liabilities: | ||||
Accounts payable and accrued liabilities | $ 214,987 | $ 182,117 | ||
Finance lease liabilities | 2,610 | 1,217 | ||
Operating lease liabilities | 8,032 | 6,909 | ||
Total current liabilities | 225,629 | 190,243 | ||
Debt, long-term | 1,155,313 | 1,125,250 | ||
Royalty financing agreement | 155,034 | 148,015 | ||
Contingent consideration | 84,600 | 51,100 | ||
Finance lease liabilities, long-term | 27,026 | 29,636 | ||
Operating lease liabilities, long-term | 11,013 | 14,853 | ||
Other long-term liabilities | 3,145 | 9,387 | ||
Total liabilities | 1,661,760 | 1,568,484 | ||
Shareholders' equity: | ||||
Common stock, | ||||
shares, 147,977,960 and 135,653,731 issued and outstanding shares at | 1,480 | 1,357 | ||
Additional paid-in capital | 3,113,487 | 2,782,416 | ||
Accumulated deficit | (3,446,145) | (2,696,578) | ||
Accumulated other comprehensive (loss) income | (745) | 756 | ||
Total shareholders' (deficit) equity | (331,923) | 87,951 | ||
Total liabilities and shareholders' equity | $ 1,329,837 | $ 1,656,435 | ||
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 global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed's first commercial product is a first-in-disease therapy approved 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 obtain, or delays in obtaining, regulatory approvals for ARIKAYCE outside 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.
With respect to the blended and blinded data observed from the ongoing TPIP studies noted above, the dose titration, efficacy, and safety analyses were based on data available as of August 28, September 12, and October 23, 2023, respectively. These findings may not be representative of results after the studies are completed and all data is collected and analyzed. As a result, later interim data readouts and final data from these studies may be materially different than the observations described above, including with respect to efficacy, safety and tolerability of TPIP.
Contact:
Investors:
Bryan Dunn
Executive Director, Investor Relations
Insmed
(646) 812-4030
bryan.dunn@insmed.com
Eleanor Barisser
Associate Director, Investor Relations
Insmed
(718) 594-5332
eleanor.barisser@insmed.com
Media:
Mandy Fahey
Executive Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated
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