Ultragenyx (RARE) Reports Wider-Than-Expected Loss In Q3

Ultragenyx (NASDAQ:RARE) reported a loss per share of $1.96 in the third quarter of 2019, wider than the Zacks Consensus Estimate of a loss of $1.71. The loss includes an unrealized gain of $2.2 million from the fair value adjustment on the investment in Arcturus equity. However, excluding this, the adjusted loss was $1.92 per share compared with a loss of $1.74 in the year-ago quarter.

For the third quarter, Ultragenyx reported $25.8 million in total revenues, up from $11.8 million in the year-ago quarter. Revenues missed the Zacks Consensus Estimate of $29 million.

Crysvita revenues were $22.6 million, which include $19.5 million of collaboration revenues in the North American profit share territory and $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 $1.1 million. Revenues also included $0.1 million received from Bayer (OTC:BAYRY) regarding Ultragenyx’s research agreement with the former to develop adeno-associated virus gene therapies. Mepsevii product revenues were $2.4 million and UX007 revenues were $0.7 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 declined 8.3% year to date against the industry's growth of 0.9%.

Pipeline Updates

The FDA approved a label expansion for Crysvita, which now includes clinical data demonstrating superiority of treatment with Crysvita versus conventional therapy in pediatric patients, and improvement in stiffness and maintenance of efficacy in adult patients with longer-term treatment. Ultragenyx plans to submit a supplemental biologics license application (sBLA) to the agency for the drug for the treatment of tumor-induced osteomalacia (TIO) in the first half of 2020.

The new drug application (NDA) for UX007 for the treatment of long-Chain fatty acid oxidation disorders (LC-FAOD) is under review by the FDA and the agency has set an action date of Jul 31, 2020.

Ultragenyxreported positive long-term results from the first two dose cohorts of DTX401 gene therapy in Glycogen Storage Disease Type Ia. Based on these data, it is conducting a confirmatory expansion cohort of three patients at the second cohort dose of 6.0 × 10^12 GC/kg. Data from this cohort are expected in the first half of 2020.

Ultragenyx and GeneTx collaborated on the development of GeneTx’s GTX-102, an antisense oligonucleotide, for the treatment of Angelman syndrome, which is a debilitating and rare neurogenetic disorder.

Our Take

Ultragenyx reported a wider-than-expected loss and missed sales estimates in the third 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 the second indication for Crysvita in TIO in the near future.

Zacks Rank and Stocks to Consider

Ultragenyx currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the biotech sector are ASLAN Pharmaceuticals Ltd. (NASDAQ:ASLN) and AVEO Pharmaceuticals Inc. (NASDAQ:AVEO) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

ASLAN’s loss per share estimates have narrowed from 79 cents to 72 cents for 2019 and from 83 cents to 71 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 24.65% on average.

AVEO’s earnings estimates have gone up from a loss of 6 cents to a profit of 1 cent a share. The company delivered a positive earnings surprise in three of the trailing four quarters by 28.34% on average.

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