Insmed Incorporated · NASDAQ:INSM
Insmed — Earnings Presentation (February 2022)
22 slides from Insmed's earnings presentation, Feb 17, 2022
Slide 1: February 17, 2022
February 17, 2022
Slide 2: Forward-looking statements
This presentation 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 uncert
Slide 3: Programs and indications overview
Refractory MAC lung disease Front Line MAC lung disease: ARISE & ENCORE Bronchiectasis: ASPEN Cystic Fibrosis (CF)Chronic Rhinosinusitis without Nasal Polyps (CRS) Hidradenitis Suppurativa (HS) Pulmonary arterial hypertension (PAH) Pulmonary hypertension associated with interstitial lung disease (PH
Slide 4: Cash position and financial outlook
$766.8M $188.5M $159.5M $16M $12.9M 13.2%$44.2M$272.7M$234.3M Cash to support ongoing business into 2024, driven by three factors: ARIKAYCE revenue How fully and broadly we pursuepipeline programs How we resource launch readiness
Slide 5: ASPEN bronchiectasis study enrollment
Currently 50% Enrolled Anticipated Enrollment CompletionEarly 2023 40 Countries ~460 Sites Patient Enrollment Initiated December 2020 DSMB Approval of Study Continuation
Slide 6: Cystic fibrosis Phase 2 study design
EOS, end of study; EOT, end of treatment; QD, once daily; Follow-up Period 4 weeks Single-Blind Treatment period 4 weeks Baselineday 1 randomization EOTday 28 EOSday 56 Up to 4 weeks PK (Cmax and AUC) of brensocatib in CF subjects after 28 days of QD oral administration Safety and tolerability of br
Slide 7: CRS and HS patient populations and unmet need
No approved treatments Many patients do not respond to corticosteroids and/or endoscopic sinus surgery (ESS) ~33M patients with CRS1 and ~26Mpatients with CRSsNP in the U.S. Targeting severe patient population Approximately 155K patients require ESS annually in the U.S.; Approximately 15%, or 23K pa
Slide 8: CRS without nasal polyps Phase 2 design
4 weeks Treatment period 24 weeks Baseline EOT(primary analysis) EOS 4 weeks Change in Total Symptom Score (TSS) NSPs in blood Change in LMK-CT (Lund-MacKaycomputed tomography) scoreChange in Sino-nasal Outcome Test 22 scoreChange in VAS (visual analog scale) Score ≥2 of the following symptoms for 1
Slide 9: Hidradenitis suppurativa Phase 2 design
Period 2OLE 36 weeks Period 116 weeks Baseline EOT(primary analysis) EOS Up to 4 weeks Percentage of subjects achieving 50% improvement as measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 Mean change in total AN (total abscesses and inflammatory nodules) count at Week 16% pa
Slide 10: ARISE and ENCORE enrollment status
Currently 50% enrolled Anticipated enrollment completion in 2022 ARISE ENCORE Enrollment Completion Anticipated in 2023Once ARISE is fully enrolled, anticipate enrollment in ENCORE to accelerate Data Expected1H23
Slide 11: TPIP profile
TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction. Simplifying dosing with once daily administration Providing prolonged, localized pulmonary vasodilationOffering improved tolerability,with fewer prostanoid-related side effectsEnabling higher d
Slide 12: TPIP Phase 2 PAH study design
4 weeks Treatment period 16 weeks Baseline EOT(primary analysis) EOS 4 weeks 2:1 active : placebo Change from baseline in pulmonaryvascular resistance (PVR) at week 16 Change from baseline in exercise capacity (6MWD)Change from baseline in WHO Functional classChange from baseline in Quality ofLife (
Slide 13: TPIP Phase 2 PH-ILD study design
4 weeks Treatment period 16 weeks Baseline EOT(primary analysis) EOS 4 weeks PK 3:1 active : placebo Safety and tolerabilityOxygenation Improvement in exercise capacity (6MWD)Improvement in biomarkers of cardiac stress (NT-proBNP)Improvement in lung function andpulmonary vascular volume (FRI)Improve
Slide 14: TPIP development timeline
Phase 2aData expected in 2022 Phase 2bFirst site initiation late 2021 PAH Phase 2Site initiation underwayPH-ILD
Slide 15: Gene therapy and de-immunization research programs
IND Candidate IdentifiedManufacturing & IND Enabling Studies IND IND Manufacturing & IND Enabling StudiesDeimmunization and POC Studies IND Enabling StudiesDeimmunization and POC Studies IND Enabling Studies Deimmunization and POC Studies IND Enabling Studies IND Capsid Deimmunization IND Transgene
Slide 16: Geographies and indications
U.S.JapanEurope CRSHSBronchiectasisCF
Slide 17: U.S. ARIKAYCE franchise and refractory MAC patients
12K-17KRefractory MAC patients(2019E)* *Source: Internal analysis of published NTM epidemiology, primary market research with treating HCPs, and anonymized patient level claims data in US U.S. ARIKAYCE franchise has remained resilient throughout the ongoing pandemic
Slide 18: Japan refractory MAC opportunity
15K-18KRefractory MACpatients(2018E)* *Source: Internal analysis of published NTM epidemiology, primary market research with treating HCPs, and anonymized patient level claims data in US Japan expected to be thesecond largest revenue generator of the markets we are pursuing
Slide 19: Europe reimbursement and refractory MAC patients
*Source: Internal analysis of published NTM epidemiology, primary market research with treating HCPs, and anonymized patient level claims data in US† European 5 comprised of France, Germany, Italy, Spain and the United Kingdom 1,400Refractory MACpatients(2018E)* ARIKAYCE currently available and reim
Slide 20: Diagnosed patient populations across indications
~340K - ~540K diagnosed patients in U.S. ~350K - ~500K diagnosed patients in Europe ~1M - ~5M diagnosed patients in Asia-Pacific ~1.7M – 6M total diagnosed patients worldwide ~35K diagnosed patients in U.S.~33K diagnosed patients in Europe~70K total diagnosed patientsworldwide ~26M patients with CRS
Slide 21: 2022-2023 anticipated milestones
2022 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 ARISE ENCORE ASPEN Phase 2 in CF Phase 2a in PAH Enrollment Completion Top-line Data Enrollment Completion Enrollment Completion Top-line Data Top-line Data Begin IND-enabling Studies Gene Therapy ProteinDe-immunization Manufacturing IND Filing in New Non-pulmonary
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