Full Press Release Details
Insmed Reports Second-Quarter 2023 Financial Results and Provides Business Update
-ARIKAYCE (amikacin liposome inhalation suspension) Total Revenue of $77.2 Million for the Second Quarter of 2023 Reflects Highest
Quarter of Sales Since Launch and 18% Growth Compared to the Second Quarter of 2022-
-Company Raises Full-Year 2023 Guidance Range for Global ARIKAYCE Revenues to $295 Million to $305 Million-
-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
BRIDGEWATER, N.J., August 3, 2023 /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 second quarter ended June 30, 2023 and provided a business update.
"The second quarter of 2023 demonstrated the strongest quarter of ARIKAYCE sales since launch, reflecting positive momentum in the U.S. and earlier than anticipated signs
of growth in Japan," commented Will Lewis, Chair and Chief Executive Officer of Insmed. "In the midst of this strong commercial performance, we are preparing for a series of data readouts that we hope will drive shareholder value and meaningful
outcomes for patients. Leveraging our growing commercial business, mid-to-late-stage pipeline assets, and early-stage research efforts, we are strategically constructing what we hope will be the next leading and self-sustaining biotechnology
Recent Pillar Highlights
Pillar 2: Brensocatib
Pillar 4: Early-Stage Research
Second-Quarter 2023 Financial Results
Balance Sheet, Financial Guidance, and Planned Investments
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 (U.S. and 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 September 3, 2023, by dialing (647) 362-9199 (U.S.
and 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 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 |
Consolidated Balance Sheets
(in thousands, except par value and share data)
| As of June 30, 2023 | As of 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, $0.01 par value; 500,000,000 authorized shares, 142,750,463 and 135,653,731 issued and outstanding shares at June 30, 2023 and December 31, 2022, respectively | 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 |
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
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 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
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.