Ultragenyx Sells European Ops for $100M

TL;DR

UGYX selling EU biz to EQT for $100M upfront to focus on US pipeline. Deal closes Q3.

AI Summary

Ultragenyx Pharmaceutical Inc. announced on June 11, 2024, that it has entered into a definitive agreement to sell its European commercial operations and related assets to an affiliate of the European private equity firm, EQT, for an upfront payment of $100 million. This transaction is expected to close in the third quarter of 2024 and aims to streamline Ultragenyx's focus on its pipeline and U.S. commercial business.

Why It Matters

This strategic divestiture allows Ultragenyx to concentrate resources on its core pipeline and U.S. market, potentially accelerating drug development and commercialization efforts.

Risk Assessment

Risk Level: medium — The sale of European operations introduces execution risk for the transaction and potential impact on future international growth, although it aims to streamline operations.

Key Numbers

• $100.0M — Upfront Payment (Received from EQT for European commercial operations.)

Key Players & Entities

• Ultragenyx Pharmaceutical Inc. (company) — Seller
• EQT (company) — Buyer's affiliate
• $100 million (dollar_amount) — Upfront payment for European operations
• June 11, 2024 (date) — Announcement date
• third quarter of 2024 (date) — Expected closing period

FAQ

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value RARE Nasdaq Global Select

Filing Documents

• rare-20240611.htm (8-K) — 47KB
• 0000950170-24-072119.txt ( ) — 157KB
• rare-20240611.xsd (EX-101.SCH) — 23KB
• rare-20240611_htm.xml (XML) — 4KB

01 Other Events

Item 8.01 Other Events. On June 11, 2024, Ultragenyx Pharmaceutical Inc. (the "Company"), together with its collaboration partner, Mereo BioPharma Group plc, announced positive 14-month results from the Phase 2 portion of the ongoing Phase 2/3 Orbit study (NCT05125809) demonstrating that, as of a May 24, 2024 data cut-off date, treatment with setrusumab (UX143) continued to significantly reduce incidence of fractures in patients with osteogenesis imperfecta ("OI") with at least 14 months of follow-up. Treatment with setrusumab also resulted in ongoing and meaningful improvements in lumbar spine bone mineral density ("BMD") at month 12 without evidence of plateau. The large reduction in annualized radiologically confirmed fracture rate previously reported in patients treated for a minimum of six months was sustained in patients treated for at least 14 months with a high degree of significance. The median annualized rate of radiologically confirmed fractures across all 24 patients in the two years prior to treatment was 0.72. Following a mean treatment duration period of 16 months, the median annualized fracture rate was reduced 67% to 0.00 (p=0.0014; n=24). The annualized fracture rate excluded morphometric vertebral fractures and fractures of the fingers, toes, skull, and face, consistent with the Phase 3 study primary efficacy endpoint. The reduction in annualized fracture rates was associated with continued, clinically meaningful increases in BMD. Tests conducted at the 12-month timepoint demonstrated that treatment with setrusumab resulted in a mean increase in lumbar spine BMD from baseline of 22% (p<0.0001, n=19) across all age groups (five to < 26 years old), a further improvement from 14% observed at six months of treatment. This increase in BMD is reflected in the change from the mean baseline lumbar spine BMD Z-score of -1.73 to -0.49 at 12 months across all age groups, a substantial normalization in Z-score of +1.25 (p<0.0001, n=18). This is further

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Ultragenyx Pharmaceutical Inc. Date: June 11, 2024 By: /s/ Howard Horn Howard Horn Executive Vice President, Chief Financial Officer, Corporate Strategy

View Full Filing

View this 8-K filing on SEC EDGAR