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Ultragenyx Pharmaceutical Inc. (RARE - Free Report) incurred a loss of $2.16 per share in fourth-quarter 2022, wider than the Zacks Consensus Estimate of a loss of $2.03. The company reported a loss of $1.79 per share in the year-ago quarter.
Ultragenyx’s total revenues amounted to $103.3 million in the fourth quarter, up 23.9% year over year. The top line beat the Zacks Consensus Estimate by 0.27%.
Shares of Ultragenyx have lost 33.7% in the year so far compared with the industry's decline of 7.1%.
Image Source: Zacks Investment Research
Ultragenyx markets three drugs, namely Crysvita, Mepsevii and Dojolvi. Crysvita is approved for treating X-linked hypophosphatemia, an inherited disorder and tumor-induced osteomalacia, an ultra-rare disease. Mepsevii is approved to treat Mucopolysaccharidosis VII (MPS VII), also known as Sly syndrome. Dojolvi was approved in June 2020 for all forms of long-chain fatty acid oxidation disorders (LC-FAOD).
Quarter in Detail
Crysvita’s total revenues were $80.6 million, up 33.9% year over year, driven by increased demand for approved indications. Crysvita revenues in Ultragenyx territories rose 33.2% to $74.6 million in the fourth quarter and included $66.9 million from the North America profit share territory and $7.7 million of net product sales for the drug in other regions. Total royalty revenues related to the sales of Crysvita in the European region were $6.1 million. Ultragenyx sold its Crysvita rights in the European territory to Royalty Pharma in December 2019.
Mepsevii product revenues were $4.8 million in the fourth quarter compared with $3.1 million reported in the year-ago quarter. Dojolvi product revenues were $16.4 million compared with $11.8 million in the year-ago quarter, driven by strong new patient demand.
Operating expenses increased 33.9% to $248.9 million in the fourth quarter. Operating expenses for the reported quarter include research and development expenses of $170.8 million and selling, general and administrative expenses of $72.8 million.
2022 Results
Revenues in 2022 came in at $363.3 million, up from $351.4 million in 2021. The net loss per share came in at $10.12 compared to a loss of $6.70 per share in 2021.
2023 Guidance
Ultragenyx expects total revenues in 2023 between $425 million and $450 million. Crysvita revenues in the range of $325-$340 million (includes 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). Dojolvi revenues are expected between $65 and $75 million
Operating expenses are expected to decrease in 2023 as the company manages headcount and increases operational leverage while executing on high value programs.
Ultragenyx Pharmaceutical Inc. Price, Consensus and EPS Surprise
Ultragenyx is evaluating GTX-102 for treating Angelman syndrome, a rare neurogenetic disorder, in a phase I/II study that continues dose exploration.
Currently, Ultragenyx is dosing patients in a phase II/III Orbit study of UX143 for the treatment of osteogenesis imperfecta (“OI”) in patients aged between five and less than 26 years. Enrollment in the phase II portion of the study is complete and data is expected in 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.
Over the past 60 days, earnings estimates for Dynavax for 2022 have increased by 11 cents to $1.95. Dynavax surpassed estimates in two of the trailing four quarters and missed in the other two, the average surprise being 73.15%.
Over the past 60 days, earnings estimates for VIR for 2022 have increased by 4 cents to $4.60. VIR topped earnings estimates in three of the last four quarters and has a four-quarter earnings surprise of 3.182.4%, on average.
Over the past 90 days, earnings estimates for KALA for 2022 have increased by 26 cents. KALA topped earnings estimates in two of the last four quarters and missed in the other two, with a four-quarter earnings surprise of 2.39% on average.
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Ultragenyx (RARE) Q4 Earnings Miss, Revenues Increase Y/Y
Ultragenyx Pharmaceutical Inc. (RARE - Free Report) incurred a loss of $2.16 per share in fourth-quarter 2022, wider than the Zacks Consensus Estimate of a loss of $2.03. The company reported a loss of $1.79 per share in the year-ago quarter.
Ultragenyx’s total revenues amounted to $103.3 million in the fourth quarter, up 23.9% year over year. The top line beat the Zacks Consensus Estimate by 0.27%.
Shares of Ultragenyx have lost 33.7% in the year so far compared with the industry's decline of 7.1%.
Image Source: Zacks Investment Research
Ultragenyx markets three drugs, namely Crysvita, Mepsevii and Dojolvi. Crysvita is approved for treating X-linked hypophosphatemia, an inherited disorder and tumor-induced osteomalacia, an ultra-rare disease. Mepsevii is approved to treat Mucopolysaccharidosis VII (MPS VII), also known as Sly syndrome. Dojolvi was approved in June 2020 for all forms of long-chain fatty acid oxidation disorders (LC-FAOD).
Quarter in Detail
Crysvita’s total revenues were $80.6 million, up 33.9% year over year, driven by increased demand for approved indications. Crysvita revenues in Ultragenyx territories rose 33.2% to $74.6 million in the fourth quarter and included $66.9 million from the North America profit share territory and $7.7 million of net product sales for the drug in other regions. Total royalty revenues related to the sales of Crysvita in the European region were $6.1 million. Ultragenyx sold its Crysvita rights in the European territory to Royalty Pharma in December 2019.
Mepsevii product revenues were $4.8 million in the fourth quarter compared with $3.1 million reported in the year-ago quarter. Dojolvi product revenues were $16.4 million compared with $11.8 million in the year-ago quarter, driven by strong new patient demand.
Operating expenses increased 33.9% to $248.9 million in the fourth quarter. Operating expenses for the reported quarter include research and development expenses of $170.8 million and selling, general and administrative expenses of $72.8 million.
2022 Results
Revenues in 2022 came in at $363.3 million, up from $351.4 million in 2021. The net loss per share came in at $10.12 compared to a loss of $6.70 per share in 2021.
2023 Guidance
Ultragenyx expects total revenues in 2023 between $425 million and $450 million. Crysvita revenues in the range of $325-$340 million (includes 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). Dojolvi revenues are expected between $65 and $75 million
Operating expenses are expected to decrease in 2023 as the company manages headcount and increases operational leverage while executing on high value programs.
Ultragenyx Pharmaceutical Inc. Price, Consensus and EPS Surprise
Ultragenyx Pharmaceutical Inc. price-consensus-eps-surprise-chart | Ultragenyx Pharmaceutical Inc. Quote
Pipeline Updates
Ultragenyx is evaluating GTX-102 for treating Angelman syndrome, a rare neurogenetic disorder, in a phase I/II study that continues dose exploration.
Currently, Ultragenyx is dosing patients in a phase II/III Orbit study of UX143 for the treatment of osteogenesis imperfecta (“OI”) in patients aged between five and less than 26 years. Enrollment in the phase II portion of the study is complete and data is expected in 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.
Zacks Rank & Stocks to Consider
Ultragenyx currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Dynavax Technologies (DVAX - Free Report) , Kala Pharmaceuticals (KALA - Free Report) and Vir Biotechnology (VIR - Free Report) , all three carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, earnings estimates for Dynavax for 2022 have increased by 11 cents to $1.95. Dynavax surpassed estimates in two of the trailing four quarters and missed in the other two, the average surprise being 73.15%.
Over the past 60 days, earnings estimates for VIR for 2022 have increased by 4 cents to $4.60. VIR topped earnings estimates in three of the last four quarters and has a four-quarter earnings surprise of 3.182.4%, on average.
Over the past 90 days, earnings estimates for KALA for 2022 have increased by 26 cents. KALA topped earnings estimates in two of the last four quarters and missed in the other two, with a four-quarter earnings surprise of 2.39% on average.