Oct 29, 2026 earnings call — Three upcoming launches and Attruby growth
Attruby U.S. net product revenue was $253.2 million this quarter, up 134% year-over-year.
Revenue $0.4B (est $0.3B) · EPS $-0.42 (est $-0.54)
Key quotes
"Net product revenue was $253 million, up 134% from Q3 of last year, driven by continued share gains in the first line."
"So put simply, we are a company with 3 launches in the next 7 months."
"I'm fairly confident that we'll average an operating loss of around $90 million to $100 million a quarter this year."
Analyst Q&A 16
Attruby near-term growth
Q (Cory Kasimov · Evercore): Is the recent $31 million sequential increase the right base for Q4 and next year? What would need to happen for that number to grow more?
A: Management said the company believes $25 million to $30 million is the right near-term range and that Attruby can grow more over time. They highlighted first-line use, diagnosis improvements, and new real-world renal data as drivers of future share gains.
"We believe that this type of data is going to continue to drive share for Attruby in Q4 and also beyond." — Matthew Outten
340B change and prescribing trends
Q (Nicholas Lorusso · TD Cowen): How could the new 340B/ASP proposals affect Attruby sales and new accounts? What Q3 trends in starts, prescribers, and persistence are leading indicators?
A: Management said gross-to-net is stable and persistency and compliance are very high, which they track closely. They noted first-line prescribers are expanding each quarter and that proposed ASP changes would not negatively impact Attruby, though final legislation is uncertain.
"Our gross to net remains and has been very stable for Attruby, and our persistency and compliance rates are extremely strong and high." — Matthew Outten
Capital allocation and M&A
Q (Joshua Schimmer · Cantor Fitzgerald): As you expand the Attruby sales force, would you prefer acquiring another product to improve call efficiency? How do you view reintegrating GondolaBio and other capital uses?
A: Management said their first capital use is to fully fund operations, including Attruby and upcoming launches. For excess capital they consider retaining cash, growing the pipeline via M&A or integrating sister companies, or share buybacks based on IRR and shareholder value.
"First use of capital is operations and fully funding the operations." — Chinmay Shukla
Cash and funding for launches
Q (Biren Amin · Piper Sandler): With about $1.5 billion cash and three upcoming launches, do you have enough to fund Attruby and the new launches and reach profitability?
A: Management said the $1.5 billion cash position is strong and they feel comfortable funding Attruby and the three upcoming launches. They expect operating loss to improve this year and margin expansion from Attruby toward breakeven into 2028.
"So yes, very strong balance sheet, as you mentioned, with $1.5 billion of cash today." — Thomas Trimarchi (CFO)
Ascendis citizen petition impact
Q (Eliana Merle · Barclays): How do you view the Ascendis citizen petition on infigratinib? Will it affect review timing, the label, or physician/family perceptions and commercial implications?
A: Management said they do not expect the petition to affect review timing or the label and view the petition as a competitive tactic with false assertions. They pointed to required tox studies, long-term data showing no CNS effects, and regulatory allowance to study younger patients as reasons clinicians are not concerned.
"We do not anticipate that this will impact the review time line or a label." — Justin To
PDUFA logistics for BBP-418
Q (Salim Syed · Mizuho): Given the holiday PDUFA timing, what logistics should we keep in mind and is the base case full approval or accelerated?
A: Management noted the question and passed it to the neuromuscular lead for details. They signaled they would provide the agency engagement context via that franchise lead.
"I'm going to pass this one on to Anna Wade, who leads the neuromuscular franchise." — Chinmay Shukla
BBP-418 FDA approval chance
Q (Anna Wade): Any update on FDA interactions and whether BBP-418 will get full approval for LGMD2I by the PDUFA date?
A: Management said agency interactions have been positive and they are confident BBP-418 will receive a traditional full approval, with the November 27 PDUFA action date on track. They expressed excitement about serving the LGMD2I community soon.
Encaleret market and Phase III plan
Q (Lin Tsai · Jefferies): With RECLAIM dosing started, how do you view the market size for hypoparathyroidism versus ADH1 and what efficacy bar is needed to take share?
A: Management passed the question to the hypopara lead to explain market sizing and study endpoints. They directed the discussion to the team running the ADH1 and hypopara programs.
"I'm going to pass it to Ananth Sridhar, who leads ADH1 and hypopara for us to answer it." — Chinmay Shukla
Hypopara market size and target cohorts
Q (Ananth Sridhar · Jefferies): How big is the chronic hypopara market vs ADH1 and which patient cohorts show strongest demand in the RECLAIM study? What is the efficacy bar?
A: Management estimated about 200,000 prevalent chronic hypopara patients in the U.S. and Europe and about 25,000 ADH1 patients. They said the strongest demand is among patients with persistent hypercalciuria, low bone mineral density, and injection-site or needle-aversion issues, and success requires robust blood and urine calcium normalization versus placebo with consistent safety.
EU MAA timing for BBP-418
Q (Anupam Rama · JPMorgan): Why plan an MAA in first half of 2028 for Europe and how does the EU limb-girdle opportunity compare to the U.S.?
A: Management said EU authorities asked to see the 36-month data as in the original protocol because Europe has less regulatory flexibility. They plan to complete the 36-month study in second half of next year and use that data for a first-half 2028 MAA, noting Europe has a larger LGMD2I population, about 4,000 patients.
"these authorities indicated that they wanted to see the 36-month data as originally contemplated in the protocol." — Anna Wade
Modeling LGMD2I launch ramp
Q (Derek Archila · Wells Fargo): How should we model the first quarters of the limb-girdle (BBP-418) launch and what KPIs will you share and when?
A: Management said field interactions and medical feedback are positive and physicians are ready to treat. They have identified 500 unique genetically diagnosed patients and expect to fully penetrate that pool by year 3, with more quantitative metrics to be shared likely around the Q4 earnings call.
"we have identified 500 unique genetically diagnosed patients to date, and we expect to fully penetrate that identified patient pool by year 3." — Anna Wade
Dose escalation in hypochondroplasia
Q (Danielle Brill Bongero · Truist): Why is the ACCEL study expanding to higher doses for hypochondroplasia, what does safety show, and will this change the pivotal timeline?
A: Management said optimal dose may differ between achondroplasia and hypochondroplasia because of mutation heterogeneity, and safety to date is clean. Given the safety profile and lack of FGFR1/2 inhibition at current doses, they feel comfortable exploring higher doses with agency support.
"we feel really comfortable exploring additional doses and the agency has supported that decision as well." — Justin To
Payer restrictions and Attruby access
Q (Jason Zemansky · BofA): A large payer reportedly restricted first-line use of a competing silencer. Does that apply to Attruby, which patients are affected, and what is the access path?
A: Management said United made a mid-2025 change to prefer Vyndamax but has made no 2026 changes to Attruby; Attruby approval rates through appeal are over 90% and the product has continued to grow quarter-over-quarter. They emphasized that in Medicare it often comes down to HCP and patient preference and that prescribers can obtain Attruby for patients.
"Our approval rates through appeal are over 90%, and Attruby continues to grow quarter-over-quarter." — Matthew Outten
Surgery type in postsurgical hypopara
Q (Joon Lee · UBS): As you enroll postsurgical hypopara patients, do you track partial vs hemi vs total thyroidectomy and could that affect responsiveness? What powering assumptions underlie RECLAIM-HP?
A: Management passed the technical question to the hypopara lead to address specifics on baseline measures and powering. They directed follow-up to the team running the study for details.
"Let me pass it on to Ananth to talk more about these questions." — Chinmay Shukla
RECLAIM-HP baseline measures and powering
Q (Ananth Sridhar · UBS): Are you assessing extent of parathyroid tissue loss and what powering assumptions did you use for RECLAIM-HP?
A: Management said direct tissue loss is hard to assess, so they measure baseline PTH, blood calcium, and urine calcium and follow changes over time. They randomized 3:1 and powered the study to detect a differential benefit on achieving concomitant normal blood and urine calcium, using Phase II signals with conservative adjustments.
Call closing remarks
Q (Pablo Elvira): (No question; closing)
A: Management thanked participants for joining the third quarter earnings call and said they look forward to updating investors next quarter. This closed the Q&A and the call.