Yahoo Finance Ultragenyx (RARE) Posts Preliminary '22 Results, Gives '23 View
Ultragenyx Pharmaceutical Inc. RARE announced preliminary results for the full year 2022. The company reported preliminary net product revenues for its marketed drugs, Crysvita and Dojolvi.
Crysvita is approved for treating X-linked hypophosphatemia, an inherited disorder and tumor-induced osteomalacia, an ultra-rare disease. Dojolvi was approved in June 2020 for all forms of long-chain fatty acid oxidation disorders.
Ultragenyx expects preliminary total product revenues to be between $352-$356 million in 2022.
The company expects preliminary Crysvita revenues to be between $277-$279 million while Crysvita revenues in Ultragenyx’s territories are expected between $257-$258 million in 2022. Preliminary Dojolvi revenues are expected to be between $55-$56 million for 2022.
Both the drugs have witnessed a strong uptake so far with Crysvita contributing a majority to the top line. The drug has also been approved by the FDA for additional indications, which is likely to further boost the company’s top line.
Shares of Ultragenyx have declined 36.2% in the past year compared with the industry’s fall of 16.6%.
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2023 Guidance
Ultragenyx predicts total product revenues of $425-$450 million for 2023. The Zacks Consensus Estimate for the metric stands at $426.4 million for the period.
The company expects total Crysvita revenues in the band of $325-$340 million while total Dojolvi revenues are anticipated in the range of $65-$75 million in 2023.
Pipeline Updates
Ultragenyx is dosing patients in a phase II/III Orbit study of UX143 (setrusumab) for the treatment of osteogenesis imperfecta (“OI”) in patients aged five to less than 26. The company expects to complete enrollment by early 2023 and intends to report data from the phase II portion of the study by mid-2023.
Ultragenyx also has plans to initiate an additional study in children with OI under five years of age in the first half of 2023.
Ultragenyx continues to enroll and dose patients in the dose escalation cohorts of the phase I/II study evaluating GTX-102 for treating Angelman syndrome, a rare neurogenetic disorder. Expansion of the dosing cohort population is anticipated in the first half of the current year.
The company is developing DTX301, an adeno-associated virus 8 (AAV8) for the treatment of patients with Ornithine transcarbamylase deficiency. DTX401, an AAV8 gene therapy candidate, is currently being evaluated for the treatment of patients with glycogen storage disease type Ia (GSDIa).
Ultragenyx is developing UX701, an AAV type 9 gene therapy product candidate for the treatment of Wilson disease, a larger rare metabolic disease.
The successful development and commercialization of the candidates are likely to boost the company’s revenues in the days ahead.
Zacks Rank & Stocks to Consider
Ultragenyx currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. SNDX, Celularity Inc. CELU and Repare Therapeutics Inc. RPTX, all sporting a Zacks Rank #1 (Strong Buy) at present.You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 7.2% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for Celularity have narrowed 17.3% for 2023 in the past 60 days.
Earnings of Celularity surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. CELU witnessed an earnings surprise of 51.01% on average.
Loss per share estimates for Repare Therapeutics have narrowed 0.3% for 2023 in the past 60 days.
Earnings of Repare Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. RPTX witnessed an earnings surprise of 240.65% on average.
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