Full Press Release Details
Insmed Reports Third-Quarter 2024 Financial Results and Provides Business Update
-ARIKAYCE (amikacin liposome inhalation suspension) Total Revenue of $93.4 Million for the Third Quarter of 2024, Reflecting 18% Growth
Over the Third Quarter of 2023-
-NDA Submission for Brensocatib in Bronchiectasis Remains on Track for the Fourth Quarter of 2024 with Potential U.S. Launch Still Expected in
-Expanded U.S. Sales Force is Now Fully Deployed; Focusing on Bronchiectasis Disease-State Awareness and Supporting the Growth of ARIKAYCE Prior to
the Anticipated Launch of Brensocatib-
-Ends the Third Quarter with ~$1.5 Billion in Cash, Cash Equivalents, and Marketable Securities-
-Renegotiates Term Loan with Pharmakon Resulting in a Lower Cost of Capital and an Additional $150 Million in Proceeds to be Received in the Fourth
-Reiterates 2024 Global ARIKAYCE Revenue Guidance in the Range of $340 Million to $360 Million, Reflecting Double-Digit Growth Compared to 2023-
BRIDGEWATER, N.J., October 31, 2024 /PRNewswire/ - Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving
to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.
"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 U.S. launch in the middle of 2025. We have also made great progress on the clinical side, with the ENCORE and PAH studies nearing full
enrollment. All of this has been accomplished while delivering yet another quarter of double-digit growth for ARIKAYCE in each of our three commercial regions. With our demonstrated ability to execute both clinically and commercially, and a
strengthened balance sheet due to actions we have taken to lower our cost of capital while adding to our cash balance, we believe we are well-positioned to deliver on the tremendous opportunities ahead."
Recent Pillar Highlights
Pillar 2: Brensocatib
Pillar 4: Early-Stage Research
Third-Quarter 2024 Financial Results
Balance Sheet, Financial Guidance, and Planned Investments
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 (U.S.) and (646) 960-0278 (international) and referencing access code 7862189. The call will also be webcast live
on the Company's website at www.insmed.com.
A replay of the conference call will be accessible approximately 1 hour after its completion through November 7, 2024, by dialing (800) 770-2030 (U.S.) and (609) 800-9909
(international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at www.insmed.com.
Consolidated Statements of Net Loss
(in thousands, except per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 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 |
Consolidated Balance Sheets
(in thousands, except par value and share data)
| As of September 30, 2024 | As of 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, $0.01 par value; 500,000,000 authorized shares, 178,846,991 and 147,977,960 issued and outstanding shares at September 30, 2024 and December 31, 2023, respectively | 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 |
ARIKAYCE is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE
inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines
recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to
hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE liposomal technology enables the delivery of amikacin
directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira Nebulizer System manufactured by PARI Pharma GmbH (PARI).
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
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.
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 U.S.
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 (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If
hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate.
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 (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate.
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 (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE,
treat patients as medically appropriate.
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 (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate.
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 (17%) compared to patients treated
with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and
dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or
suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE.
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 5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%),
hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea
(12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%).
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.
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
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