Ultragenyx ( RARE Quick Quote RARE - Free Report) reported a loss per share of $1.62 in the fourth quarter of 2019. The loss includes an unrealized gain of $1.4 million from the fair value adjustment on the investment in Arcturus equity. However, excluding this, the adjusted loss was $1.64 per share, narrower than a loss of $1.73 in the year-ago quarter and wider than the Zacks Consensus Estimate of a loss of $1.61.
For the fourth quarter, Ultragenyx reported $35.6 million in total revenues, up from $16.3 million in the year-ago quarter. Revenues beat the Zacks Consensus Estimate of $32 million.
Crysvita revenues were $29.9 million, which included $26.1 million of collaboration revenues in the North American profit share territory and $2.2 million of royalty revenues in the European territory from the collaboration and license agreement with Japanese partner, Kyowa Hakko Kirin. Net product sales for the drug in other regions were $1.6 million. Revenues also included $0.1 million received from Bayer
BAYRY regarding Ultragenyx’s research agreement with the former to develop adeno-associated virus gene therapies. Mepsevii product revenues were $4.4 million and UX007 revenues were $1.2 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.
Crysvita is approved in the United States for the treatment of X-linked hypophosphatemia in patients aged one year or above. The drug continues to deliver a strong performance in the United States.
Shares of Ultragenyx have gained 13.5% in the past year against the
industry's decline of 3.1%. Pipeline Updates
Ultragenyx submitted a supplemental Biologics License Application (sBLA) to the FDA for the treatment of Tumor-Induced Osteomalacia (TIO). The company expects a response from the FDA in February 2020.
The new drug application (NDA) for UX007 for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD) was accepted by the FDA and the agency set an action date of Jul 31, 2020.
An investigational new drug (IND) application for UX701 is expected by the end of 2020 for a new gene therapy for Wilson disease — a larger, rare metabolic disease.
Ultragenyx’s adjusted loss came in at $6.89 per share compared with a loss of $3.97 in 2018.
The company’s revenues were $103.7 million, up from $51.5 million in 2018.
Ultragenyxexpects 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.
Ultragenyx reported a wider-than-expected loss and beat sales estimates in the fourth quarter of 2019. The company looks forward to expanding the global commercial reach of its approved therapies, the FDA’s decision on the NDA for UX007 and filing for a second indication for Crysvita in TIO in the near future.
Zacks Rank and Stocks to Consider
Currently, Ultragenyx is a Zacks Rank #3 (Hold) stock.
A few better-ranked stocks in the biotech sector are Guardant Health Inc.
GH, Anavex Life Sciences Corp. AVXL. While Guardant carries a Zacks Rank #1 (Strong Buy), Anavex carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here .
Guardant’s loss per share estimates have narrowed from $1.18 to $1.13 for 2020 in the past 90 days. The company delivered a positive earnings surprise in the trailing four quarters by 39.21%, on average.
Anavex’s loss per share estimates have narrowed from 64 cents to 54 cents for 2020 and from 67 cents to 45 cents for 2021 in the past 90 days. The company delivered a positive earnings surprise of 8.26%,
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