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Ultragenyx Pharmaceutical (RARE) Q3 2026 Earnings Report

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MX:RARE Q3 2026 EPS Results

Actual EPS
-MXN 21.56
Consensus EPS
-MXN 20.45
Beat/Miss
Missed by -MXN 1.12
One Year Ago EPS
-MXN 33.65

MX:RARE Q3 2026 Revenue Results

Actual Revenue
MXN 3.22B
Expected Revenue
MXN 3.39B
Beat/Miss
Missed by -MXN 176.34M
YoY Revenue Growth
+8.17%

Earnings Announcement Details

Quarter
Q3 2026
Date
11/03/2026
Time
After Close
Conference Call
Tuesday, November 3, 2026
MX:RARE Upcoming Earnings

Ultragenyx Pharmaceutical's next earnings date is estimated for February 18, 2027, based on past reporting schedules.

Q3 2026 Earnings Call Audio

MX:RARE Q3 2026 Earnings Call
0:00 / 0:00

Q3 2026 Earnings Slide Deck

No slide deck is available for this earnings event.

Q3 2026 Earnings Call Summary

Q3 2026
Earnings Call Date:Nov 03, 2026|% Change Since:0.00%|
Earnings Call Sentiment|Neutral

The call had substantial positive developments, including two first-ever gene therapy approvals, strong demand and launch preparation, growth across established products, approximately $350 million in nondilutive proceeds, and reaffirmed 2027 profitability expectations. These were balanced by the GTX-102 Phase 3 failure, termination of UX701, a roughly 20% workforce reduction, restructuring charges, and uncertainty around the setrusumab regulatory path. Overall sentiment was mixed and balanced.

Company Guidance

Ultragenyx reaffirmed 2026 total revenue guidance of $730 million to $760 million, excluding revenue from FAYUVI and GENGLYCOS, including CRYSVITA revenue of $500 million to $520 million and DOJOLVI revenue of $100 million to $110 million, and expects combined R&D and SG&A expenses to be flat to down low single digits versus 2025, including $30 million in severance and other nonrecurring restructuring charges from the first half of the year and approximately $25 million expected in the fourth quarter; for 2027, it expects to provide full year revenue guidance early in the new year, R&D expenses of less than $350 million, a reduction of more than 50% from 2025 levels, SG&A expenses of less than $375 million, an increase of up to 7% from 2025 levels, headcount reduced by approximately 20% to a revised workforce of approximately 1,000 employees, full year GAAP net income profitability and positive cash flow from operating activities, with net proceeds from the sale of two PRVs totaling approximately $350 million.

  • Two First-Ever Gene Therapy ApprovalsThe FDA approved GENGLYCOS in August for Glycogen Storage Disease Type Ia and FAYUVI in September for Sanfilippo syndrome Type A. These approvals brought Ultragenyx to six approved medicines and its first two gene therapies.
  • GENGLYCOS and FAYUVI Launch PreparationAs of the end of October, 35 Qualified Treatment Centers were active, and the company was on track to exceed its target of 40 QTCs by year-end. The company reported a significant number of enrollment forms for both products, positive early feedback from key opinion leaders, and the first patients scheduled for infusions with approved reimbursed therapy.
  • Strong Early Demand for FAYUVIManagement said demand for FAYUVI was patient-driven, with families and physicians seeking treatment because each month of delay can affect neurodevelopment. The company reported inquiries and requests from a wide range of patient ages and from outside the United States, and expects some degree of an initial surge in utilization.
  • FAYUVI Treatment and Competitive PositioningFAYUVI is administered as a single IV infusion on an outpatient basis. Management highlighted its eight years of durable data and described the product as having an excellent safety profile, a lower treatment burden than repeated infusions or bone marrow transplantation, and what it believes is a strong position versus enzyme replacement and lentiviral gene therapy approaches.
  • GENGLYCOS Launch and Regulatory PlanGENGLYCOS demand is expected to develop more methodically because patients already have treatment options. The post-marketing program agreed with the FDA will monitor 50 commercial patients and compare them with 20 patients unable to receive treatment because of pre-existing AAV8 antibodies. Management said the program will replicate previously evaluated endpoints, including reduction in dosing frequency and time to hypoglycemia.
  • Reaffirmed 2026 Revenue GuidanceThe company reaffirmed total 2026 revenue guidance of $730 million to $760 million, excluding revenue from FAYUVI and GENGLYCOS. CRYSVITA guidance was reaffirmed at $500 million to $520 million, and DOJOLVI guidance at $100 million to $110 million.
  • Path to 2027 ProfitabilityUltragenyx reaffirmed its expectation to achieve full-year GAAP net income profitability and positive cash flow from operating activities in 2027. Management said the path is supported by continued revenue growth from four existing products, contributions from the two new gene therapy launches, and disciplined expense management and capital allocation.
  • Meaningful R&D Expense Reduction2027 R&D expense is expected to be less than $350 million, representing a reduction of more than 50% from 2025 levels. Management said the majority of 2027 R&D spending will support commercial products, including disease monitoring programs, regulatory filings, and other activities supporting approvals.
  • Nondilutive Capital Strengthened the Balance SheetThe company sold two priority review vouchers in October. Net proceeds totaled approximately $350 million after shared payments to licensors and fees, with the second transaction expected to close before the end of November. Management said the projected 2027 profitability does not include PRV income and that the company now has the cash needed to reach profitability without additional fundraising.
  • Established Product GrowthCRYSVITA continued to deliver steady growth through the first three quarters compared with the same period in 2025. Approximately 60 new patients began commercial therapy in Latin America during the quarter, bringing the regional total to more than 1,050 patients. DOJOLVI had nearly 700 patients on reimbursed therapy in North America and approximately 315 patients treated through named-patient or Early Access programs across 14 EMEA countries.
  • DOJOLVI Regulatory and Geographic ProgressDOJOLVI received conditional marketing authorization in the United Kingdom for the full long-chain fatty-acid oxidation disorder indication. The Japan launch was described as exceeding expectations, and management expects global demand to continue growing as additional regulatory filings are completed.
  • EVKEEZA GrowthEVKEEZA grew approximately 50% year-to-date compared with the same period in 2025 and was described as the biggest growth story in the third quarter. More than 500 patients across more than 20 countries were receiving EVKEEZA outside the United States.
  • Positive Setrusumab ActivityManagement said setrusumab showed clinically meaningful fracture reduction in patients with more than three fractures at baseline in both the ORBIT and COSMIC studies. The company also cited profound increases in bone mineral density, supportive pain and physical-function data, and continued patient demand to remain on treatment.
  • Setrusumab Development Remains Under EvaluationUltragenyx is discussing the regulatory pathway for setrusumab with the FDA. Management said a potential future study could focus on patients with higher fracture frequency and potentially younger patients, while any investment would be managed within the company's profitability constraints.
  • Positive DTX301 OTC DataManagement reported that DTX301 normalized ammonia levels in both patients with better control and those with poorer control. On the low-impression scale, 89% of treated patients scored plus 2 or plus 3, and 75% scored plus 3, compared with 0% for placebo. There were five hyperammonemic crises and one death in the control group versus one crisis and no deaths in the treated group.
  • Focused Pipeline and Future ProgramsThe company plans to operate with approximately five programs per year within a narrower R&D footprint. It cited IND-stage or IND-ready opportunities in creatine transporter deficiency and CDKL5, while the UX016 program for GNE myopathy is funded 100% by venture philanthropy. Management said future external opportunities will be selected selectively and within profitability constraints.
  • CRYSVITA Lifecycle PlanningUltragenyx and Kyowa Kirin are developing next-generation versions of CRYSVITA, potentially involving less frequent dosing or improved potency, in preparation for loss of exclusivity. Management said CRYSVITA remains an important global product and that the company expects to manage loss of exclusivity effectively.

MX:RARE Earnings History

MX:RARE earnings history
Report DateFiscal QuarterForecast / EPSLast Year's EPSEPS YoY ChangePress Release
Feb 18, 20272026 (Q4)44.52--23.98――
Nov 03, 20262026 (Q3)-20.45-21.56-33.6535.91% (+12.08)
Aug 04, 20262026 (Q2)-23.09-16.73-21.7523.08% (+5.02)
May 05, 20262026 (Q1)-27.66-34.20-29.19-17.20% (-5.02)
Feb 12, 20262025 (Q4)-20.32-23.98-25.847.19% (+1.86)
Nov 04, 20252025 (Q3)-22.94-33.65-26.03-29.29% (-7.62)
Aug 05, 20252025 (Q2)-24.11-21.75-28.2623.03% (+6.51)
May 06, 20252025 (Q1)-29.71-29.19-37.7422.66% (+8.55)
Feb 13, 20252024 (Q4)-24.31-25.84-28.268.55% (+2.42)
Nov 05, 20242024 (Q3)-27.59-26.03-41.4537.22% (+15.43)

The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.

Beat Missed