BridgeBio Pharma, Inc. (BBIO) Earnings

Management highlights

• Atruvi franchise: Continued commercial momentum with 24% QoQ growth and 392% YoY growth. Focus on clinical differentiation, economics of Part D orphaned drug channel. • Pipeline launches: Launch readiness for ABH1, LGMD2I, and achondroplasia brands. BridgeBio has tradition of high-quality post-Phase III regulatory submission activities. • Share repurchase program: Board authorized $500 million share repurchase program to capture value for investors. • Atruvi details: Focus on front line, 95% stabilizer preserving native tetramer, clinical differentiation studies in real-world setting. • Pipeline updates: LGMD2I NDA submission, ADH1 Phase 3 data presentation, achondroplasia trial results and commercial research, ADH1 phase three in chronic hyperthyroidism commencing summer

Guidance

• Operating loss trend: Expect loss from operations to flatten over next two quarters as ramps up launch readiness activities for next three products, then narrow toward end of 2027 toward P&L break-even and cash flow positivity. • Share repurchase: Board authorized $500 million share repurchase program which should allow shareholders to concentrate ownership in a portfolio with improved risk profile

Segment performance

Atruvi franchise: Q1 had $180.6 million of Atruvi sales and U.S. AtruviNet product revenue, a 24% growth from last quarter and 392% year-on-year growth. LGMD2I: Team went from top-line data to NDA submission in 155 days. ADH1: Upcoming top-line presentation of Calibrate Phase 3 data at European Congress of Endocrinology. Achondroplasia: Results from trial, early commercial research shows unaided awareness in excess of 40% among prescribing physician community

Risks & headwinds

• Supply chain: PYP shortage which could affect definitive diagnosis alongside ELISA assay. • Market dynamics: Uncertainties in market share gains and competitive landscape. • Clinical trial outcomes: Uncertainty around hazard ratios and competitive positioning in trials like CardioTransform

Analyst Q&A

• Q: Can you guys talk about what's driving the continued Atruvi acceleration, and specifically what you're seeing in those treatment-naive patients?

  A: Matt said acceleration driven by physicians' desire for near-complete stabilizer, TRUBY speed showing separation from placebo, real-world evidence backing up. Neil added serum TTR story with papers suggesting increases in serum TTR associating with decreases in mortality.

• Q: Walk us through operationally how you think about the development and commercial strategy for Acker Amidus in the 2031-32 and beyond?

  A: Manny was told clarity on randomized IP is positive, doesn't change commercial strategy focused on establishing Atruvi as treatment of choice, confidence in Atruvi being $4 billion drug and potential upside.

• Q: Walk us through the board's decision to authorize the $500 million share repurchase program and how you're thinking about balancing that against your investment in new launches and pipeline?

  A: Said focused on executing current opportunity, can fully finance pipeline, best relative return to deploy capital into own shares due to disconnect between intrinsic value and trading.

• Q: Can you kind of unpack, you know, what this real-world data that you're seeing, how it compares with what was demonstrated in the clinical trial setting? Is anything different now than it was or just more of it?

  A: Real-world evidence different as clinical trial had significant left shift, real-world evidence is right way to do it showing resonant advantages like diuretic intensification.

• Q: Just curious what the feedback has been there How has the additional feedback informed your expectations for the commercial opportunity?

  A: Feedback from clinician and caregivers overwhelmingly positive, ACPs asked about oral, consistent best-in-class profile resonating, proportionality data point most resonating, expect peak market share potentially more than 65%.

• Q: First on limb girdle. So you submitted the limb girdle NDA very quickly from our mouth about 150 days from top line, which is very fast compared to average. Can you walk us through where you stand on launch readiness and how you're preparing to get this drug into the hands of the limb girdle community from day one? And then a second question on the ATTR. How are you thinking about what we will see from CardioTransform, specifically and, you know, the trial is very well-powered, but what's the hazard ratio that you think could be competitive, and how are you thinking about that?

  A: Tom said proud of team for quick NDA turnaround, over to Anna who said commercial and sales leadership on board, medical leadership in place, focusing on driving awareness. Neil said CardioTransform trial well-powered, expect to hit on interrogations, commercial dynamics with L-Myelom more relevant, stabilizers likely frontline.

• Q: Know the NDA is on track here for the first half of this year. And then the press release highlighted nearly 2,000 now identifiable patients with ICD-10 code. Can you give us an update about further patient identification efforts and how this sets up how we should all be thinking about the initial launch curve?

  A: Daniel said awareness of disease and drug is catalyst, ICD-10 code advantage, analytics capabilities, family tracing as valuable source of patient identification.

• Q: Just curious how you think about infographic profile versus the injectables and how this could further accelerate, you know, this market expansion potential?

  A: Eric said physicians and families excited about total package of infographic, 2.1 centimeter change in baseline HP, only statistic proven on proportionality, differentiated safety profile, oral based will expand market on average by three to four times at year five after launch.

• Q: Speaking with the infogratnib, I want to ask with regard to the Propel infant and toddler study in patients who are newborns or up to two years old, can you comment on your updated thoughts on enrollment timing and when that might potentially be completed in the wake of your positive results from the Propel study, and just how you think about timing for that potentially being completed and being added to the label?

  A: Paul said there's excitement from sites and families after seeing phase three, will provide updates on timing later.

• Q: Now that you have succeeded across four major programs all the way through phase three, as investors think about the sustainability of your R&D engine, maybe talk about how you're currently thinking about the next wave of development beyond your portfolio and how much you're open to adding more to the pipeline in the near term, and what indication areas you could be interested in?

  A: Said very focused on executing current opportunity, has internal pipeline programs in ADPKD, LNN-Aidality cardiomyopathy, and Depleter Antibody Program in ATTR cardiomyopathy, also has sister company Gondola Bio with 17 programs.

• Q: Neil, I believe you mentioned in your prepared remarks that there were 6,100 new patient starts across the class in the quarter. If I recall correctly, this represents a pretty meaningful step up from prior quarters where I think it was more in the 4,000 new patients range. Just curious what's driving the step up here and moving forward, how should we think about the size of the quarterly patient pool that you're actively competing for?

  A: Said market continues to grow, factors include making sure algorithms are in place, driving genetic testing into heavy populations, broad position awareness and education, but keep an eye on PYP shortage.

• Q: As you look beyond the ADH1 opportunity to sort of the broader chronic hypoparathyroidism opportunity, how are you thinking about Encalaret's positioning, I guess, relative to the parathyroid hormone replacement therapies? Is there a particularly attractive subgroup to target or are you looking at sort of the broader opportunity as a whole and then maybe if you could talk about some of the pricing implications of pursuing a market that, you know, maybe looks a little bit like 25,000 patients in the U.S. and EU to, you know, versus 200,000.

  A: Said Encalaret is first oral option, can normalize both blood and urine calcium, potential safety benefit, reasons to compete in chronic hepatopathy market assuming trials work.

• Q: Can you just remind us specifically for infagradinib and achondroplasia what kind of if any commercial preparations are taking place from bridge bio?

  A: Said built strong commercial and medical leadership, trying to get word out to broader community, teams in place from Atruvi launch can help with future launches.

• Q: Patient advocacy groups for achondroplasia seem to have a pretty big voice in the indication. So, I'm wondering if you've had any interactions with them, and if you could speak to how the infogratinib profile is resonating there?

  A: Said worked alongside advocacy groups, targeting FGFR3 directly addresses their concerns, they've been wonderful partners