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Ultragenyx (RARE) Q1 Earnings & Sales Fall Short of Estimates
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Ultragenyx Pharmaceutical, Inc. (RARE - Free Report) reported loss per share of $2.04 for the first quarter of 2020, which was wider than the Zacks Consensus Estimate of a loss of $1.60 as well as the year-ago loss of $1.82 per share.
For the first quarter, Ultragenyx reported $36.3 million in total revenues, almost double from $18.1 million in the year-ago quarter. Revenues, however, missed the Zacks Consensus Estimate of $38 million.
Shares of Ultragenyx have gained 55.1% this year so far compared with the industry's increase of 3.6%.
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 total revenues were $31.4 million, which included $27.2 million of collaboration revenues in the North American profit share territory ((U.S. and Canada), $1.6 million net product sales for the drug in other regions (Latin America, Turkey) and $2.6 million in non-cash royalty revenues related to the sales of Crysvita in the European territory. Ultragenyx sold its rights to Crysvita in the European territory to Royalty Pharma in December 2019. In Ultragenyx territories (North America, Latin America and Turkey), Crysvita revenues were $28.8 million.
The company saw continued strong demand for Crysvita in North America with more than 80% of patients receiving Crysvita through at-home nurse administration, which reduced the impact of COVID-19 related disruption. However, the company expects to face challenges for new patient starts for Crysvita.
Mepsevii product revenues were $2.6 million and UX007 revenues were $1.4 million. Though UX007 is not an approved product, the company recognizes sales from the candidate on a “named patient” basis. This is allowed in certain countries prior to the commercial approval of a product.
The company said it has not seen any disruptions in supply/distribution of its medicines amid the COVID-19 pandemic. It said it has enough inventory and does not expect any shortages even if there is an interruption in the supply chain in future months.
Total operating costs in the quarter were $157.0 million, up 33.7% year over year.
2020 Guidance
The company maintained its previously issued guidance.
Ultragenyx expects Crysvita revenues from its territories between $125 million and $140 million, which excludes European territory revenues.
The company also expects a more than 20% reduction in net cash burn in 2020 compared with 2019.
Pipeline Updates
The company is also looking to expand the label of Crysvita, which has been developed for the treatment of tumor-induced osteomalacia (TIO). A supplemental biologics license application is under priority review with the FDA
An important pipeline candidate is UX007, which has been developed for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD). A new drug application seeking approval of UX007 for LC-FAOD is under standard review with the FDA with a decision expected on Jul 31. Along with the earnings release, the company said the FDA reviews for Crysvita for TIO and UX007 for LC-FAOD are on track and the decisions are expected on the scheduled dates.
UX007 is also being evaluated in a phase III study in patients with glucose transporter type-1 deficiency syndrome (Glut1 DS), a brain energy deficiency, who are experiencing movement disorders.
The company also has some gene therapy candidates in its pipeline including DTX301, an adeno-associated virus 8 (AAV8), which is being evaluated in a phase I/II study for the treatment of patients with Ornithine transcarbamylase (OTC) deficiency. The company plans to begin enrollment in a phase III study on DTX301 in the first half of 2021.
DTX401 is also an AAV8 gene-therapy candidate being evaluated in a phase I/II study for the treatment of patients with glycogen storage disease type Ia, (GSDIa). Enrollment is complete in the study’s confirmatory cohort with data expected in the second quarter.
Amgen’s earnings per share estimates for 2021 have increased from $16.91 to $17.01 over the past 30 days.
Amarin’s earnings per share estimates have moved up from 12 cents to 14 cents for 2020 and from 76 cents to 78 cents for 2021 in the past 30 days.
Immunomedics’ loss per share estimates have narrowed from $1.66 to $1.60 for 2020 and from $1.01 per share to 87 cents for 2021 in the past 30 days. The company’s stock has surged 52.2% so far this year.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Ultragenyx (RARE) Q1 Earnings & Sales Fall Short of Estimates
Ultragenyx Pharmaceutical, Inc. (RARE - Free Report) reported loss per share of $2.04 for the first quarter of 2020, which was wider than the Zacks Consensus Estimate of a loss of $1.60 as well as the year-ago loss of $1.82 per share.
For the first quarter, Ultragenyx reported $36.3 million in total revenues, almost double from $18.1 million in the year-ago quarter. Revenues, however, missed the Zacks Consensus Estimate of $38 million.
Shares of Ultragenyx have gained 55.1% this year so far compared with the industry's increase of 3.6%.
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 total revenues were $31.4 million, which included $27.2 million of collaboration revenues in the North American profit share territory ((U.S. and Canada), $1.6 million net product sales for the drug in other regions (Latin America, Turkey) and $2.6 million in non-cash royalty revenues related to the sales of Crysvita in the European territory. Ultragenyx sold its rights to Crysvita in the European territory to Royalty Pharma in December 2019. In Ultragenyx territories (North America, Latin America and Turkey), Crysvita revenues were $28.8 million.
The company saw continued strong demand for Crysvita in North America with more than 80% of patients receiving Crysvita through at-home nurse administration, which reduced the impact of COVID-19 related disruption. However, the company expects to face challenges for new patient starts for Crysvita.
Mepsevii product revenues were $2.6 million and UX007 revenues were $1.4 million. Though UX007 is not an approved product, the company recognizes sales from the candidate on a “named patient” basis. This is allowed in certain countries prior to the commercial approval of a product.
The company said it has not seen any disruptions in supply/distribution of its medicines amid the COVID-19 pandemic. It said it has enough inventory and does not expect any shortages even if there is an interruption in the supply chain in future months.
Total operating costs in the quarter were $157.0 million, up 33.7% year over year.
2020 Guidance
The company maintained its previously issued guidance.
Ultragenyx expects Crysvita revenues from its territories between $125 million and $140 million, which excludes European territory revenues.
The company also expects a more than 20% reduction in net cash burn in 2020 compared with 2019.
Pipeline Updates
The company is also looking to expand the label of Crysvita, which has been developed for the treatment of tumor-induced osteomalacia (TIO). A supplemental biologics license application is under priority review with the FDA
An important pipeline candidate is UX007, which has been developed for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD). A new drug application seeking approval of UX007 for LC-FAOD is under standard review with the FDA with a decision expected on Jul 31. Along with the earnings release, the company said the FDA reviews for Crysvita for TIO and UX007 for LC-FAOD are on track and the decisions are expected on the scheduled dates.
UX007 is also being evaluated in a phase III study in patients with glucose transporter type-1 deficiency syndrome (Glut1 DS), a brain energy deficiency, who are experiencing movement disorders.
The company also has some gene therapy candidates in its pipeline including DTX301, an adeno-associated virus 8 (AAV8), which is being evaluated in a phase I/II study for the treatment of patients with Ornithine transcarbamylase (OTC) deficiency. The company plans to begin enrollment in a phase III study on DTX301 in the first half of 2021.
DTX401 is also an AAV8 gene-therapy candidate being evaluated in a phase I/II study for the treatment of patients with glycogen storage disease type Ia, (GSDIa). Enrollment is complete in the study’s confirmatory cohort with data expected in the second quarter.
Zacks Rank
Ultragenyx is a Zacks Rank #3 (Hold) stock.
Ultragenyx Pharmaceutical Inc Price and Consensus
Ultragenyx Pharmaceutical Inc price-consensus-chart | Ultragenyx Pharmaceutical Inc Quote
Some better-ranked stocks in the biotech sector are Amgen (AMGN - Free Report) , Amarin Corporation (AMRN - Free Report) and Immunomedics , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Amgen’s earnings per share estimates for 2021 have increased from $16.91 to $17.01 over the past 30 days.
Amarin’s earnings per share estimates have moved up from 12 cents to 14 cents for 2020 and from 76 cents to 78 cents for 2021 in the past 30 days.
Immunomedics’ loss per share estimates have narrowed from $1.66 to $1.60 for 2020 and from $1.01 per share to 87 cents for 2021 in the past 30 days. The company’s stock has surged 52.2% so far this year.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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