Preliminary 2022 Total Product Revenue of $352 million to $356 million, Crysvita® Revenue in Ultragenyx Territories1 of $257 million to $258 million and Dojolvi® revenue of $55 million to $56 million
2023 expected Total Product Revenue guidance between $425 million to $450 million, Crysvita revenue of $325 million to $340 million, and Dojolvi revenue of $65 million to $75 million
Year-end 2022 cash balance of approximately $900 million and 2023 guidance for net cash used in operations expected to be less than $400 million
NOVATO, Calif., Jan. 06, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultrarare genetic diseases, today reported preliminary unaudited 2022 revenue results, cash and investments at year end 2022, and provided 2023 guidance on select key financial metrics including net cash used in operations.
“We have made substantial investments in our pipeline and manufacturing capabilities over the last two years that put us in a special position to advance multiple transformative treatments in late-stage development while continuing to drive revenue growth, delivering approved medicines globally for rare disease patients,” said Emil D. Kakkis, M.D., Ph.D., chief executive officer and president of Ultragenyx. “We have also made a substantial effort to focus on key value drivers within the pipeline and reduce cash spending to maintain our strong financial position through 2023.”
Ultragenyx will present at the 41ᵗʰ annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023 at 9:45 a.m. PT. The live and archived webcast of the presentation will be accessible from the company’s website at https://ir.ultragenyx.com/events-presentations.
Financial Update
2022 Revenue (unaudited) and 2023 Revenue Guidance ($ in millions)
| 2022 | 2023 | ||
| Preliminary Revenue | Revenue Guidance | ||
| Crysvita in Ultragenyx Territories1 | $257 - $258 | ||
| Total Crysvita | $277 - $279 | $325 - $340 | |
| Dojolvi | $55 - $56 | $65 - $75 | |
| Total Product Revenue | $352 - $356 | $425 - $450 |
In 2023, Crysvita guidance is provided for all regions where Ultragenyx will recognize revenue, including the royalties in Europe, which have been ongoing, and the royalties in North America, which will begin in April 2023. The mid-point of the Total Crysvita guidance range represents a 20% year-over-year growth rate, as compared to the same regions in 2022.
2022 Ending Cash Position (unaudited) and 2023 Cash Used in Operations GuidanceCash, cash equivalents, and available-for-sale investments were approximately $900 million as of December 31, 2022. Cash uses in 2022 included non-recurring items of approximately $90 million for capital expenses for the gene therapy manufacturing facility, which is nearing completion, $75 million for the acquisition of GeneTx and $30 million upfront fee related to the Evkeeza® license and collaboration agreement.
In 2023 with increased focus on key pipeline value drivers, net cash use is projected to be meaningfully reduced. Net Cash Used in Operations for 2023 is expected to be less than $400 million.
The 2022 revenues and cash position included in this release are preliminary and are therefore subject to adjustment. The preliminary revenue results are based on management’s initial analysis of operations for the year ended December 31, 2022. The Company expects to issue full financial results for the fourth quarter and fiscal year 2022 in February 2023.
Recent Updates and 2023 Clinical Milestones
UX143 (setrusumab) monoclonal antibody for Osteogenesis Imperfecta (OI): Phase 2/3 study dosing patients; Phase 2 data expected in mid-2023Ultragenyx is currently dosing patients in the Phase 2/3 Orbit study of UX143 in pediatric and adult patients with OI aged five to