Insmed Incorporated · NASDAQ:INSM
Insmed — Investor Presentation (June 2024)
32 slides from Insmed's investor presentation, Jun 4, 2024
Slide 1: Insmed Incorporated Commercial Presentation June 4, 2024
Insmed Incorporated Commercial Presentation June 4, 2024
Slide 2: Forward Looking Statements
Forward Looking Statement 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 hist
Slide 3: Additional Disclaimers
Forward Looking Statement Additional Disclaimers With respect to the blended and blinded data observed from the ongoing TPIP study in pulmonary arterial hypertension, the dose titration and efficacy analyses were based on data available as of April 1, 2024, and the safety analyses were based on data
Slide 4: Positive clinical data have transformed Insmed's value
This presentation is intended to help frame the commercial potential for TPIP, ARIKAYCE and brensocatib POSITIVE CLINICAL DATA have transformed Insmed’s value In the last 9 months…
Slide 5: A portfolio of multi-indication programs each with blockbuster potential
Refractory MAC NTM** All MAC NTM Bronchiectasis CRSsNP HS PH-ILD PAH A portfolio of multi-indication programs each with blockbuster potential* TPIP PH-ILD=Pulmonary hypertension due to interstitial lung disease; PAH=Pulmonary arterial hypertension MAC=Mycobacterium avium complex; NTM=nontuberculous
Slide 6: Potential addressable patients anticipated to grow substantially
30K brensocatib Bronchiectasis TPIP PH-ILD Potential addressable patients anticipated to grow substantially with a steady cadence of launches* ARIKAYCE Refractory MAC 1.25M brensocatib CRSsNP 400K TPIP PAH 135K 90K future (through 2030) ~2.5M Bronchiectasis refers to non-cystic fibrosis bronchiectas
Slide 7: Three therapies with positive clinical data in-hand
Three therapies with positive clinical data in-hand have potential to be first- and/or best-in-disease* >$2bn Max. dose well-tolerated Nominally stat. sig. benefit on clinical worsening TPIP PH-ILD Phase 2 Bronchiectasis refers to non-cystic fibrosis bronchiectasis PVR reduction including placebo si
Slide 8: TPIP: Pulmonary Arterial Hypertension and PH-ILD
TPIP Pulmonary Arterial Hypertension (PAH) A devastating and debilitating disease that pervades all aspects of a patient’s daily life Pulmonary Hypertension due to Interstitial Lung Disease (PH-ILD) A rapidly progressing disease associated with poor survival and decreased quality of life Image Sourc
Slide 9: TPIP has potential to clearly differentiate from other treatments in PH-ILD and PAH
TPIP has the potential to clearly differentiate from other treatments in PH-ILD and PAH Higher Dosing Tolerability may lead to improved outcomes Safety** Favorable safety profile Convenience* Once daily inhalation TPIP TPIP Remodulin® Tyvaso® Yutrepia® Orenitram® Uptravi® Route of administration Inh
Slide 10: PH-ILD is a significant potential commercial opportunity
Diagnosed with BE15 TPIP TPIP – PH-ILD PH-ILD is a significant potential commercial opportunity, with ~135k patients 65K 50K 20K 190K 150K 45K PH-ILD1 Diagnosed PH1 Japan TAM US TAM EU5 † TAM Tyvaso DPI List Price* U.S. Pricing Benchmark $300K *Wholesale acquisition cost (WAC) as of March 12, 2024 †
Slide 11: TPIP represents potential best-in-class prostanoid for PAH
Diagnosed with BE15 40K 35K 15K 190K 150K 45K PAH2 Diagnosed PH2 TPIP represents potential best-in-class* prostanoid for ~90k patients with PAH Japan TAM US TAM Tyvaso DPI List Price* EU5 † TAM U.S. Pricing Benchmark $300K *Wholesale acquisition cost (WAC) as of March 12, 2024 For references, please
Slide 12: Prostacyclins expected to remain cornerstone of PAH therapy
Phase 3 STELLAR trial suggests that sotatercept will be complementary with treprostinil products Note: Prostacyclins are part of the prostacyclin receptor agonist class Prostacyclins expected to remain cornerstone of PAH therapy; TPIP has potential to be prostacyclin of choice Regardless of sotaterc
Slide 13: ARIKAYCE: Refractory MAC lung disease
ARIKAYCE Refractory Mycobacterium avium complex lung disease (rMAC LD) A rare and chronic disease that can cause irreversible lung damage and is the most common form of NTM respiratory pathogen Mycobacterium avium complex lung disease (MAC LD) Image source: Hendrix C, McCrary M, Hou R, Abate G. Diag
Slide 14: ARIKAYCE potential to address ~275K patients
Japan TAM US TAM EU5† TAM Diagnosed with BE15 1.4K 12-17K 15-18K 95-115K 14K 125-145K ARIKAYCE Refractory MAC5 MAC LD5 ARIKAYCE ARIKAYCE has the potential to be best in MAC LD treatment regimen to address ~275K patients TAM=Total Addressable Market For references, please refer to slides 29-32 †EU5 c
Slide 15: Physician and patient overlap between NTM and BE is high
ARIKAYCE brensocatib Physician and patient overlap between NTM and BE is high Insmed has strong relationships in this space, spanning 6+ years Bronchiectasis refers to non-cystic fibrosis bronchiectasis For references, please refer to slides 29-32 Bronchiectasis (BE) and nontuberculous mycobacterial
Slide 16: ARIKAYCE delivered a top non-oncology rare disease launch
In 2018, ARIKAYCE delivered a top 10 non-oncology rare disease launch… ARIKAYCE brensocatib 2018 2025 94% Current sales reps who have sold ARIKAYCE for more than 1 year 5x HCP targets 31x Patient volume Increase in stakeholders7 Consistency of field 67% Current field team that launched ARIKAYCE Pati
Slide 17: Brensocatib: Bronchiectasis
BRENSOCATIB Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Hidradenitis Suppurativa (HS) Bronchiectasis (BE) A chronic, progressive inflammatory disease that causes permanent lung damage Bronchiectasis refers to non-cystic fibrosis bronchiectasis Image Source: 1) Fraser CS, José RJ. Insights i
Slide 18: Bronchiectasis could represent a >1M patient indication at launch
Japan TAM *Includes misdiagnosed, miscoded, undiagnosed †EU5 comprised of France, Germany, Italy, Spain and the United Kingdom Note: COPD and asthma may be comorbid with bronchiectasis and not all patients with bronchiectasis have comorbid asthma or COPD Bronchiectasis could represent a >1M patient
Slide 19: Specialty pulmonary medications as precedents for launch pricing
Other specialty pulmonary medications could be precedents for launch pricing ~$40k U.S. Launch List Price12,13 $96k Severe eosinophilic asthma Idiopathic pulmonary fibrosis ~2.5M prevalent U.S. patients 130K prevalent U.S patients Specialty pulmonary medications Indication Market Size14,15 brensocat
Slide 20: Disease state education and field expansion well underway
Disease state education and field expansion well underway Scientific Exchange Disease State Field Expansion 77 Publications of bronchiectasis and brensocatib* 36+ Global congresses, society, and patient advocacy meetings annually Physician Digital, congress & live events Patient Digital and social c
Slide 21: Strong signals that uptake at launch could be rapid
Motivated to act17 Intend to prescribe16 Recognize disease burden18 *Since website launch in November 2023 **Highly engaged defined as those patients who have downloaded support tools or registered for CRM †From February-May 2024; Commercial lives include VA, Tricare and DOD Strong signals from stak
Slide 22: Brensocatib: Chronic Rhinosinusitis without Nasal Polyps
BRENSOCATIB Hidradenitis Suppurativa (HS) Bronchiectasis (BE) Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) A burdensome disease that significantly impairs quality of life Image source: Yang Y, Zhang N, Crombruggen KV, Lan F, Hu G, Hong S, Bachert C. Differential Expression and Release of Act
Slide 23: CRSsNP is a significant symptomatic patient population
Diagnosed with BE15 Japan TAM CRSsNP is a significant symptomatic patient population, many of whom are progressing toward surgery CRSsNP Prevalence19 CRSsNP Steroid Non responders (Prevalence)19 Annual New Surgical Patients (Incidence)19 160K 200K 40K US TAM 3.1M 2.6M 0.5M 29M 24M 6M brensocatib - C
Slide 24: Brensocatib: Hidradenitis Suppurativa
BRENSOCATIB Bronchiectasis (BE) Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) Hidradenitis Suppurativa (HS) A chronic, recurrent and debilitating inflammatory disease with significant treatment challenges Image source: Z.N. Ovadja, M.M. Schuit, C.M.A.M. van der Horst, O. Lapid, Inter‐ and int
Slide 25: Phase 2 HS trial with potential addressable market >600K patients
Diagnosed with BE15 300K 275K 30K 1.2M – 2.6M Global HS Diagnosed Prevalence20 Hurley Stage 2 & 320 Japan TAM US TAM EU5† TAM brensocatib - HS Anticipated rapid initiation of Phase 2 HS trial by year-end with potential addressable market of >600K patients if successful TAM=Total Addressable Market F
Slide 26: Strong, long-dated patent exclusivity
brensocatib a Based on U.S. Patent Application No.18/024,040 and ex-U.S. counterpart applications issuing as patents. Additionally, given the complexity of drug product (liposomal inhalation with specific nebulizer), required bioequivalence testing could be difficult and lead to few generic entrants
Slide 27: Expected pipeline catalysts provide additional opportunities for valuation inflection
sNDA submission MAC LD ENCORE Enrollment Complete ASPEN TLR (P3) NCFBE Launch in US * NCFBE Launch in EU, UK * NCRBE Launch in Japan * ARIKAYCE 2025 2026 brensocatib Expected pipeline catalysts provide additional opportunities for valuation inflection ARISE TLR (P3) HS P2 Initiation ENCORE TLR CRSsN
Slide 28: References
References insmed
Slide 29: References (1 of 4)
Internal assessment of published epidemiology, including: Andersen, C. U., Mellemkjær, S., Hilberg, O., Nielsen-Kudsk, J. E., Simonsen, U., & Bendstrup, E. (2012). Pulmonary hypertension in interstitial lung disease: prevalence, prognosis and 6 min walk test. Respiratory medicine, 106(6), 875-882. R
Slide 30: References (2 of 4)
Internal analysis of published NTM epidemiology, including internal market research and US patient level claims data analysis: Jennifer Adjemian, Kenneth N Olivier, Amy E Seitz, Steven M Holland, D Rebecca Prevots: Prevalence of nontuberculous mycobacterial lung disease in U.S. Medicare beneficiarie
Slide 31: References (3 of 4)
References (3 of 4) Internal analysis and estimations based on internal market research and US patient level claims data analysis: Insmed Analysis 2022: Potential Undiagnosed or Misdiagnosed (with COPD, Asthma) BE patients in US estimated based on Medical Experts driven insights, applied to Patient
Slide 32: References (4 of 4)
References (4 of 4) Reuters; Nov 15 2017. AstraZeneca pricing new severe asthma drug Fasenra below rivals Pulmonary Fibrosis News.com/Two New IP Treatments Reportedly Will Cost 94K-96K American Lung Association/Severe Asthma Raghu G, Weycker D, Edelsberg J, Bradford WZ, Oster G. Incidence and preval