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Ultragenyx's (RARE) Q4 Earnings & Revenues Miss Estimates
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Ultragenyx Pharmaceutical Inc. (RARE - Free Report) incurred a loss of $1.79 per share for fourth-quarter 2021, wider than the Zacks Consensus Estimate of a loss of $1.32. The company reported a loss of $1.34 per share in the year-ago quarter.
Ultragenyx’s total revenues of $83.4 million in the fourth quarter declined 8.8% year over year. The top line slightly missed the Zacks Consensus Estimate of $84 million.
Shares of Ultragenyx have plunged 56.2% in the past year compared with the industry's decline of 38.3%.
Image Source: Zacks Investment Research
Ultragenyx markets three drugs, namely Crysvita, Mepsevii and Dojolvi. 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 in June 2020 for all forms of long-chain fatty acid oxidation disorders (LC-FAOD).
Full-Year Results
For 2021, Ultragenyx generated total revenues of $351.4 million compared with $271 million recorded in 2020.
For full-year 2021, the company reported a loss of $6.70 per share compared with net loss of $3.07 per share in 2020.
Quarter in Detail
Crysvita’s total revenues were $60.2 million, up 36.8% year over year, driven by increased demand for both approved indications. Crysvita revenues in Ultragenyx territories rose 37.2% to $55.4 million in the quarter and included $50.2 million from the North America profit share territory as well as $5.3 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 $3.1 million in the quarter compared with $3.6 million reported in the year-ago quarter. Dojolvi product revenues were $11.8 million compared with $6.4 million in the year-ago quarter, driven by strong new patient demand. Revenues in the quarter also included $8.2 million in relation to Ultragenyx’s collaboration and license agreement with Daiichi Sankyo.
Operating expenses decreased 0.9% to $185.9 million in the quarter due to pipeline advancements. The company continues to support its six clinical programs that are currently enrolling patients.
In January 2022, Ultragenyx announced a license and collaboration agreement with Regeneron Pharmaceuticals (REGN - Free Report) . Per the deal, Ultragenyx has obtained rights to develop, commercialize and distribute Evkeeza (evinacumab) outside the United States. The regions include the European Economic Area.
Evkeeza is approved in these regions for use with diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to treat patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH).
Evkeeza was discovered and developed by Regeneron. REGN launched the medicine in the United States in February 2021.
Please note that the collaboration with Regeneron for Evkeeza gives Ultragenyx a fourth approved product that can add to its revenues along with Crysvita, Mepsevii, and Dojolvi.
2022 Guidance
The company expects Crysvita revenues to be in the range of $250-$260 million in Ultragenyx territories. Dojolvi revenues are expected in the band of $55-$65 million.
Pipeline Updates
In October 2021, Ultragenyx initiated a seamless phase I/II/III study on UX701, an AAV type 9 gene therapy product candidate, for the treatment of Wilson disease — a rare metabolic disease.
Ultragenyx, along with partner GeneTx, is developing GTX-102 for treating patients with Angelman syndrome. In October 2021, the company dosed the first patient in a phase I/II study on GTX-102 for treating patients with Angelman syndrome in Canada. In September 2021, the FDA removed the clinical hold from the phase I/II study evaluating GTX-102 for the treatment of Angelman syndrome.
Ultragenyx Pharmaceutical Inc. Price, Consensus and EPS Surprise
Image: Bigstock
Ultragenyx's (RARE) Q4 Earnings & Revenues Miss Estimates
Ultragenyx Pharmaceutical Inc. (RARE - Free Report) incurred a loss of $1.79 per share for fourth-quarter 2021, wider than the Zacks Consensus Estimate of a loss of $1.32. The company reported a loss of $1.34 per share in the year-ago quarter.
Ultragenyx’s total revenues of $83.4 million in the fourth quarter declined 8.8% year over year. The top line slightly missed the Zacks Consensus Estimate of $84 million.
Shares of Ultragenyx have plunged 56.2% in the past year compared with the industry's decline of 38.3%.
Ultragenyx markets three drugs, namely Crysvita, Mepsevii and Dojolvi. 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 in June 2020 for all forms of long-chain fatty acid oxidation disorders (LC-FAOD).
Full-Year Results
For 2021, Ultragenyx generated total revenues of $351.4 million compared with $271 million recorded in 2020.
For full-year 2021, the company reported a loss of $6.70 per share compared with net loss of $3.07 per share in 2020.
Quarter in Detail
Crysvita’s total revenues were $60.2 million, up 36.8% year over year, driven by increased demand for both approved indications. Crysvita revenues in Ultragenyx territories rose 37.2% to $55.4 million in the quarter and included $50.2 million from the North America profit share territory as well as $5.3 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 $3.1 million in the quarter compared with $3.6 million reported in the year-ago quarter. Dojolvi product revenues were $11.8 million compared with $6.4 million in the year-ago quarter, driven by strong new patient demand. Revenues in the quarter also included $8.2 million in relation to Ultragenyx’s collaboration and license agreement with Daiichi Sankyo.
Operating expenses decreased 0.9% to $185.9 million in the quarter due to pipeline advancements. The company continues to support its six clinical programs that are currently enrolling patients.
In January 2022, Ultragenyx announced a license and collaboration agreement with Regeneron Pharmaceuticals (REGN - Free Report) . Per the deal, Ultragenyx has obtained rights to develop, commercialize and distribute Evkeeza (evinacumab) outside the United States. The regions include the European Economic Area.
Evkeeza is approved in these regions for use with diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to treat patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH).
Evkeeza was discovered and developed by Regeneron. REGN launched the medicine in the United States in February 2021.
Please note that the collaboration with Regeneron for Evkeeza gives Ultragenyx a fourth approved product that can add to its revenues along with Crysvita, Mepsevii, and Dojolvi.
2022 Guidance
The company expects Crysvita revenues to be in the range of $250-$260 million in Ultragenyx territories. Dojolvi revenues are expected in the band of $55-$65 million.
Pipeline Updates
In October 2021, Ultragenyx initiated a seamless phase I/II/III study on UX701, an AAV type 9 gene therapy product candidate, for the treatment of Wilson disease — a rare metabolic disease.
Ultragenyx, along with partner GeneTx, is developing GTX-102 for treating patients with Angelman syndrome. In October 2021, the company dosed the first patient in a phase I/II study on GTX-102 for treating patients with Angelman syndrome in Canada. In September 2021, the FDA removed the clinical hold from the phase I/II study evaluating GTX-102 for the treatment of Angelman syndrome.
Ultragenyx Pharmaceutical Inc. Price, Consensus and EPS Surprise
Ultragenyx Pharmaceutical Inc. price-consensus-eps-surprise-chart | Ultragenyx Pharmaceutical Inc. Quote
Zacks Rank & Stock to Consider
Ultragenyx currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include Axsome Therapeutics, Inc. (AXSM - Free Report) and Editas Medicine, Inc. (EDIT - Free Report) , both sportinga Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Axsome Therapeutics’ loss per share estimates have narrowed 0.8% for 2022 over the past 60 days.
Earnings of Axsome Therapeutics have surpassed estimates in three of the trailing four quarters, and missed the same on the other occasion.
Editas Medicine’s loss per share estimates have narrowed 1.4% for 2022 over the past 60 days.
Earnings of Editas Medicine have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions.