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Ultragenyx's (RARE) Q3 Earnings & Revenues Beat Estimates

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Ultragenyx Pharmaceutical Inc. (RARE - Free Report) incurred a loss of $1.08 per share for third-quarter 2021, narrower than the Zacks Consensus Estimate of a loss of $1.43. The company reported a loss of $1.13 per share in the year-ago quarter.

Ultragenyx’s total revenues of $81.6 million in the third quarter grew marginally 0.2% year over year. The top line also surpassed the Zacks Consensus Estimate of $78 million.

Shares of Ultragenyx have plunged 38.7% so far this year compared with the industry's decline of 8.9%.

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Quarter in Detail

Ultragenyx markets three drugs, namely Crysvita, Mepsevii and Dojolvi (UX007). Crysvita is approved for the treatment of 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 last year for all forms of long-chain fatty acid oxidation disorders (LC-FAOD).

Crysvita’s total revenues were $55 million, up 35.3% year over year, driven by increased demand for both approved indications. Crysvita revenues in Ultragenyx territories rose 34.8% to $50.3 million in the quarter and included $42.9 million from the North America profit share territory as well as $7.4 million of net product sales for the drug in other regions. Total royalty revenues related to the sales of Crysvita in the European Territory were $4.7 million. Ultragenyx sold its Crysvita rights in the European territory to Royalty Pharma in December 2019.

Mepsevii product revenues were $3.9 million in the quarter, down 3.9% year over year. Dojolvi (UX007) product revenues were $10.6 million compared with $3.8 million in the year-ago quarter, driven by strong new patient demand. Revenues in the quarter also included $12.1 million in relation to Ultragenyx’s collaboration and license agreement with Daiichi Sankyo.

Operating expenses rose 30% to $171.5 million in the quarter due to pipeline advancements. The company continues the commercialization of Dojolvi and supports six clinical programs, including four pivotal studies.

2021 Guidance

Owing to a strong performance in the third quarter of 2021, the company now expects Crysvita revenues toward the upper end of the guidance it provided earlier in the year. This range is $180-$190 million.

Pipeline Updates

In September 2021, Ultragenyx and its partner GeneTx announced that the FDA has removed the clinical hold from their phase I/II study evaluating GTX-102 for the treatment of Angelman syndrome, a rare neurogenetic disorder.

The companies can now begin dosing naïve patients in the above-mentioned study for treating pediatric patients with Angelman syndrome.

Last month, Ultragenyx and GeneTx dosed the first patient in a phase I/II study in Canada, evaluating GTX-102 for the treatment of Angelman syndrome. Three other patients have been enrolled and scheduled for dosing. Patient dosing in the United Kingdom and the United States is expected to begin shortly.

A preliminary update from the first four patients in the study is expected by the end of 2021 with complete data anticipated in mid-2022.

Zacks Rank & Stocks to Consider

Ultragenyx currently carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the biotech sector include Agenus Inc. (AGEN - Free Report) , Amicus Therapeutics, Inc. (FOLD - Free Report) and Athenex, Inc. (ATNX - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Agenus’ loss per share estimates have narrowed 17.8% for 2021 and 20.6% for 2022, over the past 60 days. The stock has rallied 37.1% year to date.

Amicus Therapeutics’ loss per share estimates have narrowed 1.3% for 2021 and 37.5% for 2022, over the past 60 days.

Athenex’s loss per share estimates have narrowed 9% for 2021 and 9.2% for 2022, over the past 60 days.