Full Press Release Details
Insmed Reports First-Quarter 2024 Financial Results and Provides Business Update
- ARIKAYCE (amikacin liposome inhalation suspension)
Total Revenue of $75.5 Million for the First Quarter of 2024, Reflecting 16% Annual Growth Over the First Quarter of 2023-
-Company Reports Positive Topline Safety and Tolerability Data from the Phase 2 PH-ILD Study of TPIP with 79.3% of Patients Reaching the
Maximum Dose of 640 g by Week 5, with an Unexpectedly Positive and Robust Signal on the Exploratory Endpoint of Clinical Worsening-
-Encouraging Blinded Data from First 40 Patients in Phase 2 PAH Study of TPIP, with Combined Active Treatment and
Placebo Arms Showing Mean PVR Reduction of 19.9% and 6-Minute Walk Distance Improvement of 43 Meters-
-Topline Data from the Phase 3 ASPEN Trial of Brensocatib in Patients with Bronchiectasis Remains on Track to Read Out in the Latter
Part of Second-Quarter 2024-
-Company 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., May 9, 2024 /PRNewswire/ - Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of
patients with serious and rare diseases, today reported financial results for the first quarter ended March 31, 2024 and provided a business update.
"Today, Insmed kicked off a series of crucial data readouts, starting with TPIP, where we continue to observe a favorable safety and tolerability profile from
the Phase 2 PH-ILD trial results as well as encouraging additional blinded PVR data from the Phase 2 PAH trial. Together, we believe these results continue to position TPIP as a potential best-in-class prostanoid," said Will Lewis, Chair and
Chief Executive Officer of Insmed. "We now await with great anticipation the ASPEN trial results, which are expected in the latter half of this quarter. Supporting our research efforts is the ARIKAYCE commercial engine, which produced
double-digit revenue growth this quarter, keeping us on track to meet our 2024 revenue guidance."
Recent Pillar Highlights
Pillar 2: Brensocatib
Pillar 4: Early-Stage Research
First-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 June 8, 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 March 31, | ||||||||
| 2024 | 2023 | |||||||
| Product revenues, net | $ | 75,500 | $ | 65,214 | ||||
| Operating expenses: | ||||||||
| Cost of product revenues (excluding amortization of intangible assets) | 17,457 | 13,830 | ||||||
| Research and development | 121,083 | 127,865 | ||||||
| Selling, general and administrative | 93,102 | 79,914 | ||||||
| Amortization of intangible assets | 1,263 | 1,263 | ||||||
| Change in fair value of deferred and contingent consideration liabilities | (11,900 | ) | (9,500 | ) | ||||
| Total operating expenses | 221,005 | 213,372 | ||||||
| Operating loss | (145,505 | ) | (148,158 | ) | ||||
| Investment income | 8,783 | 10,524 | ||||||
| Interest expense | (21,042 | ) | (20,003 | ) | ||||
| Change in fair value of interest rate swap | 2,362 | (1,533 | ) | |||||
| Other expense, net | (1,100 | ) | (111 | ) | ||||
| Loss before income taxes | (156,502 | ) | (159,281 | ) | ||||
| Provision for income taxes | 589 | 483 | ||||||
| Net loss | $ | (157,091 | ) | $ | (159,764 | ) | ||
| Basic and diluted net loss per share | $ | (1.06 | ) | $ | (1.17 | ) | ||
| Weighted average basic and diluted common shares outstanding | 148,456 | 136,355 |
Consolidated Balance Sheets
(in thousands, except par value and share data)
| As of | As of | |||||||
| March 31, 2024 | December 31, 2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 595,729 | $ | 482,374 | ||||
| Marketable securities | - | 298,073 | ||||||
| Accounts receivable | 37,162 | 41,189 | ||||||
| Inventory | 82,957 | 83,248 | ||||||
| Prepaid expenses and other current assets | 42,874 | 24,179 | ||||||
| Total current assets | 758,722 | 929,063 | ||||||
| Fixed assets, net | 68,660 | 65,384 | ||||||
| Finance lease right-of-use assets | 20,307 | 20,985 | ||||||
| Operating lease right-of-use assets | 17,157 | 18,017 | ||||||
| Intangibles, net | 62,441 | 63,704 | ||||||
| Goodwill | 136,110 | 136,110 | ||||||
| Other assets | 95,698 | 96,574 | ||||||
| Total assets | $ | 1,159,095 | $ | 1,329,837 | ||||
| Liabilities and shareholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 189,362 | $ | 214,987 | ||||
| Current portion of long-term debt | 224,194 | - | ||||||
| Finance lease liabilities | 2,695 | 2,610 | ||||||
| Operating lease liabilities | 4,609 | 8,032 | ||||||
| Total current liabilities | 420,860 | 225,629 | ||||||
| Debt, long-term | 939,081 | 1,155,313 | ||||||
| Royalty financing agreement | 156,967 | 155,034 | ||||||
| Contingent consideration | 63,700 | 84,600 | ||||||
| Finance lease liabilities, long-term | 26,320 | 27,026 | ||||||
| Operating lease liabilities, long-term | 13,809 | 11,013 | ||||||
| Other long-term liabilities | 3,166 | 3,145 | ||||||
| Total liabilities | 1,623,903 | 1,661,760 | ||||||
| Shareholders' equity: | ||||||||
| Common stock, $0.01 par value; 500,000,000 authorized shares, 148,560,882 and 147,977,960 issued and outstanding shares at March 31, 2024 and December 31, 2023, respectively | 1,486 | 1,480 | ||||||
| Additional paid-in capital | 3,138,578 | 3,113,487 | ||||||
| Accumulated deficit | (3,603,236 | ) | (3,446,145 | ) | ||||
| Accumulated other comprehensive loss | (1,636 | ) | (745 | ) | ||||
| Total shareholders' deficit | (464,808 | ) | (331,923 | ) | ||||
| Total liabilities and shareholders' deficit | $ | 1,159,095 | $ | 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 patient care.
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
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.
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.
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 the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company is progressing a robust
pipeline of investigational therapies targeting areas of serious unmet need, including neutrophil-mediated inflammatory diseases and rare pulmonary disorders. Insmed is also advancing an early-stage research engine encompassing a wide range of
technologies and modalities, including artificial intelligence-driven protein engineering, gene therapy, and protein manufacturing. Insmed is headquartered in Bridgewater, New Jersey, with additional offices and research locations throughout
the United States, Europe, and Japan. Visit www.insmed.com to learn more.
Forward-looking Statements