Insmed Reports Second-Quarter 2023 Financial Results and Provides Business Update
- None.
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-- ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of
-- Company Raises Full-Year 2023 Guidance Range for Global ARIKAYCE Revenues to
-- Topline Data from Post-Marketing ARISE Study of ARIKAYCE Expected in September of 2023 --
-- Blended Blinded Dose Titration Data for TPIP in PH-ILD and PAH Expected in Second Half of 2023 --
-- Topline Data from the Phase 3 ASPEN Trial of Brensocatib in Adult Patients with Bronchiectasis Remains on Track to Read Out in the Second Quarter of 2024 --
"The second quarter of 2023 demonstrated the strongest quarter of ARIKAYCE sales since launch, reflecting positive momentum in the
Recent Pillar Highlights
Pillar 1: ARIKAYCE
- ARIKAYCE global revenue grew
18% in the second quarter of 2023 compared with the second quarter of 2022 and reflects the strongest quarter of sales since commercial launch, supported by contributions from theU.S. ,Japan , andEurope . - Insmed continues to advance the post-marketing, confirmatory trial program for ARIKAYCE, consisting of the ARISE and ENCORE studies in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung infection who have not started antibiotics. Insmed anticipates sharing topline efficacy and safety data from the ARISE study in September of 2023.
- The Company remains on track to enroll 250 patients in the registrational ENCORE study by the end of 2023. Insmed continues to anticipate reevaluating the targeted enrollment for ENCORE following the ARISE data readout.
Pillar 2: Brensocatib
- Insmed continues to expect topline data from the
ASPEN study, a global Phase 3 trial designed to assess the efficacy, safety, and tolerability of brensocatib in bronchiectasis, in the second quarter of 2024. - The fourth meeting of the Data Safety and Monitoring Board was held in May, where it was recommended that the
ASPEN study continue as planned. - The Company plans to initiate a Phase 2 study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) in the fourth quarter of 2023.
Pillar 3: TPIP
- Insmed continues to enroll patients in a Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and a Phase 2 study in pulmonary arterial hypertension (PAH).
- The Company anticipates sharing interim, blinded dose titration and safety and tolerability data from both the PH-ILD and PAH Phase 2 studies in the second half of 2023, pending the rate of enrollment.
- Insmed remains on track to report topline results from the Phase 2 study of TPIP in PH-ILD in the first half of 2024.
Pillar 4: Early-Stage Research
- The Company plans to initiate a clinical trial of its Duchenne muscular dystrophy (DMD) gene therapy in the second half of 2023 and expects to share muscle biopsy data for at least one patient in the first half of 2024.
- Insmed anticipates filing 1-2 investigational new drug (IND) applications for its gene therapy programs in 2024, including one for Stargardt disease. Insmed also anticipates accomplishing full capsid production capabilities from AlgaeneX, its proprietary manufacturing platform, in 2024.
- Insmed expects to submit its first IND filing application from its Deimmunized by Design platform in 2025. The Company also anticipates submitting an IND filing application in ataxia telangiectasia in 2025, which is the result of the June 2023 acquisition of Adrestia Therapeutics Ltd.
Second-Quarter 2023 Financial Results
- Total revenue for the second quarter ended June 30, 2023, was
, reflecting the Company's strongest quarter of sales to date and$77.2 million 18% growth compared to total revenue of for the second quarter of 2022.$65.2 million - Total revenue for the second quarter of 2023 was comprised of ARIKAYCE net sales of
in the$57.7 million U.S. , in$15.6 million Japan , and in$4.0 million Europe and rest of world, reflecting22% year-over-year growth in theU.S. This also reflects strong sequential growth from each region compared to first-quarter 2023 revenues. - Cost of product revenues (excluding amortization of intangibles) was
for the second quarter of 2023, compared to$16.6 million for the second quarter of 2022, reflecting increased sales volumes of ARIKAYCE.$16.4 million - Research and development (R&D) expenses were
for the second quarter of 2023, compared to$197.0 million for the second quarter of 2022 and$88.5 million for the first quarter of 2023. The increase in R&D expenses was primarily attributable to the$127.9 million non-cash cost of the acquisition of Adrestia Therapeutics in June 2023, as well as continued investments in ongoing late-stage pipeline programs. Excluding any non-cash charges associated with acquisitions, second-quarter 2023 R&D expenses were comparable with the first quarter of 2023.$76.5 million - Selling, general and administrative (SG&A) expenses for the second quarter of 2023 were
, compared to$84.4 million for the second quarter of 2022 and$60.0 million for the first quarter of 2023. The year-over-year increase in SG&A expenses was primarily driven by commercial readiness activities for brensocatib as well as an increase in headcount.$79.9 million - Insmed reported a net loss of
, or$244.8 million per share, for the second quarter of 2023, compared to a net loss of$1.78 , or$95.6 million per share, for the second quarter of 2022, and a net loss of$0.80 , or$159.8 million per share, for the first quarter of 2023.$1.17
Balance Sheet, Financial Guidance, and Planned Investments
- As of June 30, 2023, Insmed had cash, cash equivalents, and marketable securities totaling
, down from$918 million as of March 31, 2023, reflecting the ongoing support of the ARIKAYCE franchise, commercial readiness activities for brensocatib, and clinical operations for its mid- to late-stage pipeline programs.$999 million - Insmed is raising its sales guidance for full-year 2023 global revenues for ARIKAYCE to a range of
to$295 million from a range of$305 million to$285 million previously.$300 million - Insmed continues to anticipate that over
80% of total 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 invest in the following key activities in 2023:
- commercialization and expansion of ARIKAYCE globally;
- advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis and commercial launch readiness activities, as well as initiation of the Phase 2 trial in patients with CRSsNP;
- advancement of the clinical trial program for ARIKAYCE (ARISE and ENCORE), 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;
- advancement of its Phase 2 clinical development programs for TPIP; and
- development of its early-stage research platforms.
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 (646) 960-0278 (
A replay of the conference call will be accessible approximately 1 hour after its completion through September 3, 2023, by dialing (647) 362-9199 (
INSMED INCORPORATED | |||||||
Consolidated Statements of Net Loss | |||||||
(in thousands, except per share data) | |||||||
(unaudited) | |||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
Product revenues, net | $ 77,229 | $ 65,221 | $ 142,443 | $ 118,328 | |||
Operating expenses: | |||||||
Cost of product revenues (excluding amortization of intangible assets) | 16,594 | 16,395 | 30,424 | 28,586 | |||
Research and development | 196,969 | 88,527 | 324,834 | 172,883 | |||
Selling, general and administrative | 84,431 | 59,974 | 164,345 | 116,722 | |||
Amortization of intangible assets | 1,263 | 1,263 | 2,526 | 2,526 | |||
Change in fair value of deferred and contingent consideration liabilities | 13,500 | (12,622) | 4,000 | (24,240) | |||
Total operating expenses | 312,757 | 153,537 | 526,129 | 296,477 | |||
Operating loss | (235,528) | (88,316) | (383,686) | (178,149) | |||
Investment income | 11,172 | 835 | 21,696 | 972 | |||
Interest expense | (20,619) | (3,357) | (40,622) | (6,648) | |||
Change in fair value of interest rate swap | 1,184 | - | (349) | - | |||
Other expense, net | (488) | (4,306) | (599) | (5,555) | |||
Loss before income taxes | (244,279) | (95,144) | (403,560) | (189,380) | |||
Provision for income taxes | 530 | 501 | 1,013 | 886 | |||
Net loss | $ (244,809) | $ (95,645) | $ (404,573) | $ (190,266) | |||
Basic and diluted net loss per share | $ (1.78) | $ (0.80) | $ (2.95) | $ (1.60) | |||
Weighted average basic and diluted common shares outstanding | 137,553 | 119,602 | 136,957 | 119,267 |
INSMED INCORPORATED | ||||
Consolidated Balance Sheets | ||||
(in thousands, except par value and share data) | ||||
As of | As of | |||
June 30, 2023 | December 31, 2022 | |||
(unaudited) | ||||
Assets | ||||
Current assets: | ||||
Cash and cash equivalents | $ 612,882 | $ 1,074,036 | ||
Marketable securities | 304,886 | 74,244 | ||
Accounts receivable | 30,947 | 29,713 | ||
Inventory | 77,349 | 69,922 | ||
Prepaid expenses and other current assets | 26,360 | 25,468 | ||
Total current assets | 1,052,424 | 1,273,383 | ||
Fixed assets, net | 62,113 | 56,491 | ||
Finance lease right-of-use assets | 22,341 | 23,697 | ||
Operating lease right-of-use assets | 16,476 | 21,894 | ||
Intangibles, net | 66,230 | 68,756 | ||
Goodwill | 136,110 | 136,110 | ||
Other assets | 83,445 | 76,104 | ||
Total assets | $ 1,439,139 | $ 1,656,435 | ||
Liabilities and shareholders' equity | ||||
Current liabilities: | ||||
Accounts payable and accrued liabilities | $ 197,653 | $ 182,117 | ||
Finance lease liabilities | 2,445 | 1,217 | ||
Operating lease liabilities | 4,159 | 6,909 | ||
Total current liabilities | 204,257 | 190,243 | ||
Debt, long-term | 1,139,805 | 1,125,250 | ||
Royalty financing agreement | 152,020 | 148,015 | ||
Contingent consideration | 46,400 | 51,100 | ||
Finance lease liabilities, long-term | 28,370 | 29,636 | ||
Operating lease liabilities, long-term | 12,871 | 14,853 | ||
Other long-term liabilities | 11,161 | 9,387 | ||
Total liabilities | 1,594,884 | 1,568,484 | ||
Shareholders' equity: | ||||
Common stock, | ||||
shares, 142,750,463 and 135,653,731 issued and outstanding | 1,428 | 1,357 | ||
Additional paid-in capital | 2,945,229 | 2,782,416 | ||
Accumulated deficit | (3,101,151) | (2,696,578) | ||
Accumulated other comprehensive (loss) income | (1,251) | 756 | ||
Total shareholders' (deficit) equity | (155,745) | 87,951 | ||
Total liabilities and shareholders' equity | $ 1,439,139 | $ 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 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 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, 2022 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
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
FAQ
What is the total revenue reported by Insmed Incorporated for Q2 2023?
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What is the updated guidance for global ARIKAYCE revenues for full-year 2023?
When is the topline data from the ARISE study of ARIKAYCE expected?
What data is expected for TPIP in PH-ILD and PAH in the second half of 2023?