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Ultragenyx (RARE) Q4 Loss Narrows Y/Y, Revenues Beat Estimates

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Ultragenyx Pharmaceutical, Inc. (RARE - Free Report) reported a loss per share of 37 cents for the fourth quarter of 2020 compared with a loss of $1.62 in the year-ago quarter. However, the fourth-quarter 2020 loss included one-time gain of $79.1-million of increase in the fair value of investments in equity securities. Excluding this one-time gain, the loss came in at $1.59 per share in the fourth quarter of 2020 compared with a loss of $1.64 in the year-ago quarter. The Zacks Consensus Estimate was pegged at a loss of $1.06 per share.

For the fourth quarter, Ultragenyx reported $91.5 million in total revenues, up f157% from the year-ago quarter. Revenues surpassed the Zacks Consensus Estimate of $71 million.

Shares of Ultragenyx have surged 158.9% in the past year compared with the industry's growth of 14.3%.

Ultragenyx markets three drugs, Crysvita, Mepsevii and Dojolvi (UX007). 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. In June 2020, the FDA approved Dojolvi for the treatment of pediatric and adult patients with any form of Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) with a molecularly-confirmed diagnosis

Crysvita’s total revenues were $40.4 million, which included $37.5 million of collaboration revenues in Ultragenyx territories and $2.9 million of net product sales for the drug in other regions. Total royalty revenues related to European Crysvita sales were $3.6 million. Ultragenyx sold its Crysvita rights in the European territory to Royalty Pharma in December 2019.

Mepsevii product revenues were $3.7 million in the quarter. Dojolvi (UX007) product revenues were $6.4 million. Revenues for the fourth quarter also included $37.5 million related to the collaboration and license agreement with Daiichi Sankyo for Ultragenyx’s proprietary AAV-based gene therapy manufacturing technologies, which was executed in March 2020.

Full-Year 2020 Results

The company reported a loss of $3.07 per share for 2020, narrower than a loss of $7.12 in 2019. However, the 2020 loss included a one-time gain $170.4-million fair value of investments in equity securities. Excluding this one-time gain, the loss came in at $5.88 per share in 2020 compared with a loss of $7.36 in 2019. The Zacks Consensus Estimate was pegged at a loss of $3.82 per share for 2020.

For 2020, Ultragenyx reported $271 million in total revenues, up 161.3% from the year-ago quarter. Revenues surpassed the Zacks Consensus Estimate of $253.25 million.

2021 Guidance

The company reaffirmed the guidance range for Crysvita which it provided at the beginning of 2021 when it released preliminary sales numbers for the drug. This range is $180 million to $190 million in the Ultragenyx territories

Pipeline Update

The Investigational New Drug (IND) application for UX701 for Wilson disease was cleared by the FDA in January 2021. The company currently expects to initiate a seamless, single-protocol phase I/II/III study in the first half of 2021. 

Following scientific advice with the European Medicines Agency (EMA) and an end of phase II meeting with the FDA, the company expects to initiate a phase III study for DTX401 for glycogen storage disease type Ia (GSDIa) in the first half of 2021.

Zacks Rank & Stocks to Consider

Ultragenyx is a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks in the healthcare sector include Acorda Therapeutics Inc. (ACOR - Free Report) , Atea Pharmaceuticals Inc. (AVIR - Free Report) and Alexion Pharmaceuticals Inc. (ALXN - Free Report) . All of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Acorda’s loss per share estimates have narrowed from $9.66 to $8.48 for 2020 and from $9.60 to $7.33 for 2021 over the past 60 days.

Atea’s earnings per share estimates have increased from $3.53 to $3.70 for 2021 over the past 60 days. Shares of the company have increased 189.8% in the past year.

Alexion’s earnings per share estimates have increased from $12.67 to $12.82 for 2021 and from $13.89 to $14.08 for 2022 over the past 60 days. Shares of the company have increased 46.9% in the past year.

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