Bridgebio Pharma, Inc. · NASDAQ:BBIO
Bridgebio Pharma — J.P. Morgan Healthcare Conference 2024
25 slides from Bridgebio Pharma's conference presentation, Jan 8, 2024
Slide 1: BridgeBio JPM Presentation 2024
—|—.. bridgebio JPM Presentation 2024
Slide 2: Forward-Looking Statement and Disclaimer
Forward-Looking Statement and Disclaimer The presentation may contain forward-looking statements. Statements made or presented may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Sect
Slide 3: We are at the starting line
We are at the starting line Focus for today *https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229282/#bib32 2024 Commercial development and execution Late-stage development Research & early development BridgeBio Business Segments ATTR-CM Achondroplasia, LGMD2i, ADH1, CAH – all $1bn+ markets 10+ ongoing
Slide 4: Where we play: genetic medicine, where it is still Day 1
Where we play: genetic medicine, where it is still Day 1 8,000+ genetic diseases, most without a therapy Higher probability of technical success versus other areas 100s of actionable opportunities to create first- or best-in-class drugs More information – UKB 500K whole genomes. The complete human r
Slide 5: How we play: our R&D engine is purpose-built for genetic medicine
How we play: our R&D engine is purpose-built for genetic medicine INDs under $10m Time from start to IND < 3yrs Fast-to-fail decision criteria Incented teams on only their project Central resources to variabilize fixed cost Experience across 20+ trials,25+ countries, 500+ sites including key childre
Slide 6: We are at the starting line
We are at the starting line Focus for today *https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229282/#bib32 2024 Commercial development and execution Late-stage development Research & early development BridgeBio Business Segments ATTR-CM 10+ ongoing programs We are building a next generation integrated
Slide 7: Learnings across ATTR-CM since JP Morgan 2023
Learnings across ATTR-CM since JP Morgan 2023 Acoramidis provides unprecedented absolute survival and hospitalization rates As a highly potent next generation stabilizer, acoramidis demonstrated absolute survival and hospitalization rates approaching age-matched general population1,2,3 Acoramidis de
Slide 8: Near-complete TTR stabilization leads to improved clinical outcomes
Near-complete TTR stabilization leads to improved clinical outcomes Early separation in composite outcomes Unprecedented absolute survival and hospitalization rates A Evidence of improvement for large proportion of patients B C Patients on acoramidis are surviving more and going to the hospital less
Slide 9: Near-complete TTR stabilization leads to improved clinical outcomes
Near-complete TTR stabilization leads to improved clinical outcomes Early separation in composite outcomes Unprecedented absolute survival and hospitalization rates A Evidence of improvement for large proportion of patients B C Patients on acoramidis are surviving more and going to the hospital less
Slide 10: Near-complete TTR stabilization leads to improved clinical outcomes
Near-complete TTR stabilization leads to improved clinical outcomes Early separation in composite outcomes Unprecedented absolute survival and hospitalization rates A Evidence of improvement for large proportion of patients B C Patients on acoramidis are surviving more and going to the hospital less
Slide 11: Early increase in serum TTR is an independent predictor of improved survival
Data from ATTRibute-CM demonstrate early increase in serum TTR is an independent predictor of improved survival in ATTR-CM Statistical modeling demonstrates that acoramidis-mediated increase in serum TTR at Day 28 is an independent predictor of survival. A Source: Preliminary analyses (modeled data)
Slide 12: Higher serum TTR levels may be available to patients who switch to a potent stabilizer
Higher serum TTR levels may be available to patients who switch from a partial stabilizer to a potent, near-complete stabilizer Month 0 1 3 6 9 12 15 18 21 24 27 30 OLE: M1 M6 M12 Acoramidis Acoramidis+Tafamidis Placebo+Tafamidis Placebo Phase 3 OLE (Acoramidis only) Serum TTR Mean Change from Basel
Slide 13: Preliminary evidence of amyloid regression on CMR imaging
Preliminary evidence of amyloid regression on CMR imaging demonstrated in ATTRibute-CM imaging sub-study ECV = Extracellular volume, an imaging correlate of amyloid deposition Source: Preliminary sample of ATTRibute-CM CMR imaging Regression ECV 65% ECV 58% ECV 68% ECV 78% Baseline Month 30 Increase
Slide 14: We have hired a commercial team with strong CV experience
We have hired a commercial team with strong CV experience and existing relationships with COEs Undiagnosed patients and unmet need with currently approved medications fuels future market growth We are building a customer facing team that is sized to effectively maximize the opportunity Sources: Data
Slide 15: Backbone of Therapy
Backbone of Therapy Additional analyses from ATTRibute-CM Generate new evidence to support diagnosis and treatment Continued Evidence Generation Access & Affordability Ensure broad and sustained access and affordability Design best-in-class patient and provider support Reinforce benefits of near-com
Slide 16: Independent market research estimates 25-40% market share for acoramidis
Independent market research estimates 25-40% market share for acoramidis in a future 4-product market Acoramidis Estimated Market Share as % of Future 4-Product Market 27-40% 25-30% 25-29% 25-40% Method 1 US Cardiologist Research N=184 Method 2 EU Cardiologist Research N=25 Method 3 US Cardiologist
Slide 17: Cardiovascular markets are dominated by orally administered products
Cardiovascular markets are dominated by orally administered products Source: Evaluate Pharma Percentage of cardiovascular sales by route of administration (%) 2013 2014 2015 2016 2017 2018 2019 2020 2021 90% 10% 90% 10% 89% 11% 88% 2012 87% 13% 87% 13% 87% 13% 87% 13% 87% 13% 87% 13% 2022 85% 15% 12
Slide 18: Acoramidis go-to-market strategy in place ahead of anticipated 2024 launch
Acoramidis go-to-market strategy in place ahead of anticipated 2024 launch with robust lifecycle plans underway Detailed Results from ATTRibute-CM European Society of Cardiology August 2023 American Heart Association November 2023 Submit New Drug Application (NDA) with FDA November 2023 Submit addit
Slide 19: We are at the starting line
We are at the starting line Focus for today *https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229282/#bib32 2024 Commercial development and execution Late-stage development Research & early development BridgeBio Business Segments ATTR-CM 10+ ongoing programs We are building a next generation integrated
Slide 20: Low-dose oral FGFR inhibitor (infigratinib) for achondroplasia
Low-dose oral FGFR inhibitor (infigratinib) for achondroplasia Data from Cohort 5 of Phase 2 study of infigratinib presented this year 1PROPEL observational lead in study; 2Savarirayan 2020; 3FDA Summary Basis of Approval (imputed from individual waterfall charts) Genetic Driver FGFR3 gain-of-functi
Slide 21: BBP-418 for Limb-Girdle Muscular Dystrophy Type 2I
BBP-418 for Limb-Girdle Muscular Dystrophy Type 2I Genetic Driver FKRP partial loss-of-function mutation Stage Phase 3 Total addressable market $1Bn+ Design principles First-in-class disease modifying treatment Key next steps Phase 3 is enrolling rapidly (ahead of projections) Completion of enrollme
Slide 22: Encaleret for ADH1
Encaleret has the potential to restore physiologic mineral homeostasis in patients with ADH1 Phase 2B results demonstrated rapid and sustained normalization of serum calcium, urine calcium, and serum PTH in response to encaleret therapy. No serious adverse events were reported with encaleret.2 Encal
Slide 23: BBP-631 for congenital adrenal hyperplasia (CAH)
Genetic Driver Loss of 21-hydroxylase Design Principle Best-in-class efficacy (upstream and downstream effects) Stage Phase 2 Total addressable market $2Bn+ Loss of 21-hydroxylase in CAH causes loss of cortisol, and shunting of 17OHP into androgens BBP-631 for congenital adrenal hyperplasia (CAH) CR
Slide 24: Early data show BBP-631 enables classic CAH patients to increase cortisol production
Early data show that BBP-631 is the first therapeutic option enabling classic CAH patients to increase endogenous cortisol production; more follow-up is needed 1.7x 1.7x 5.4x 3.6x 67x 70x Fold increase in 11-deoxycortisol from baseline to Wk 12 In-clinic cortisol levels measured post-ACTH stim Pt. 1
Slide 25: 2024 at a high level
2024 at a high level Launch Acoramidis: Establish acoramidis as the backbone of therapy in ATTR-CM Fully enroll our ongoing Phase 3 trials, and readout Phase 2 in CAH: Complete enrollment for achondroplasia, ADH1, LGMD2I, and make a go/no-go Phase 2 decision on our CAH program Establish a strong fin
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