Ultragenyx Pharmaceutical, Inc. RARE reported a loss per share of $1.13 for the third quarter of 2020 compared with a loss of $1.96 in the year-ago quarter. However, the third-quarter 2020 loss included an unrealized gain of $11.5 million. Excluding this gain, the loss came in at $1.32 per share in the third quarter compared with a loss of $2 in the year-ago quarter. The Zacks Consensus Estimate was pegged at a loss of $1.24.
For the third quarter, Ultragenyx reported $81.5 million in total revenues, up from $25.8 million in the year-ago quarter. Revenues surpassed the Zacks Consensus Estimate of $55 million.
Shares of Ultragenyx have surged 124.7% this year so far against the industry's decline of 4.3%.
Ultragenyx markets two drugs, Crysvita and Mepsevii. While Crysvita is approved for the treatment of X-linked hypophosphatemia, an inherited disorder due to the excessive loss of phosphate, Mepsevii is approved to treat Mucopolysaccharidosis VII (MPS VII), also known as Sly syndrome.
Crysvita’s total revenues were $37.3 million, which included $34.1 million of collaboration revenues in the North American profit share territory (the United States and Canada) and $3.3 million of net product sales for the drug in other regions. Total royalty revenues related to European Crysvita sales were $3.3 million. Ultragenyx sold its rights to Crysvita in the European territory to Royalty Pharma in December 2019.
Mepsevii product revenues were $4.1 million and Dojolvi (UX007) product revenues in the initial quarter of our commercial launch were $3.9 million. Revenues for the third quarter also included $32.9 million of revenues related to the collaboration and license agreement with Daiichi Sankyo, which was executed in March 2020.
Total operating costs in the quarter were $131.8 million, up 8.4% year over year.
The company increased the lower end of the guidance range for 2020 Crysvita revenues to $130 million from $125 million. The updated guidance range is currently $130-$140 million.
The FDA approved Dojolvi (UX007) for the treatment of pediatric and adult patients withanyform of Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) with a molecularly-confirmed diagnosis. Dojolvi is the first FDA-approved therapy for these lifelong and life-threatening genetic disorders and now available to patients in the United States.Dojolvi has been submitted for approval with ANVISA in Brazil and to Health Canada after being granted priority review.
The FDA approved a second indication for Crysvita in June 2020. Crysvita is now available for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in TIO associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older.
The European Commission (EC) approved Crysvita for the treatment of XLH in older adolescents and adults. This label expansion adds to the prior indication, which included children and adolescents with growing skeletons, and now includes adolescents with radiographic evidence of bone disease, regardless of growth status, as well as adults with XLH are now also eligible for treatment with Crysvita.
Zacks Rank & Stocks to Consider
Ultragenyx is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in the biotech sector are Emergent BioSolutions Inc. EBS, ADC Therapeutics SA ADCT and Adicet Bio, Inc. ACET. While Emergent sports a Zacks Rank #1 (Strong Buy), ADC Therapeutics and Adicet Bio carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings per share estimates have increased from $4.23 to $6.61 for 2020 and from $6.17 to $8.42 for 2021 in the past 60 days.
ADC Therapeutics’ loss per share estimates have narrowed from $4.37 to $4.32 for 2020 and from $3.19 to $3.08 for 2021 in the past 60 days.
Adicet Bio’s loss per share estimates have narrowed from $5.74 to $1.03 for 2020 and from $4.34 to $3.06 in the past 60 days.
Ultragenyx Pharmaceutical Inc. Price, Consensus and EPS Surprise
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