Theravance Biopharma, Inc. (TBPH - Free Report) reported second-quarter 2018 loss of $0.76 per share, narrower than the Zacks Consensus Estimate of a loss of $1.24 and the year-ago loss of $1.27.
Total revenues in the quarter under review surged a massive 475% year over year to $23 million owing to higher revenues from Theravance’s only marketed drug Vibativ as well as higher collaboration revenues. Moreover, the top line surpassed the Zacks Consensus Estimate of $10.5 million.
Shares of Theravance were up 7.1% on Aug 1 following the company's earnings release. However, the stock has decreased 8.1% so far this year, wider than the industry’s decline of 1.2%.
Vibativ generated U.S. revenues of $5.4 million in the second quarter, up 53% from the year-ago period's figure. Revenues from collaborations were $18.11 million compared with $35,000 in the year-earlier quarter. This upside can mainly be attributed to revenues recognized with respect to the opt-in payment received from Alfasigma for velusetrag and upfront payment from J&J (JNJ - Free Report) for the commercialization agreement of TD-1473 to treat inflammatory diseases.
Research and development expenses were $48.6 million, up 13.3% from the year-ago period while selling, general & administrative expenses rose 2.9% to $25 million.
Pipeline and Other Updates
In February 2018, Theravance entered into a global collaboration agreement with Janssen to jointly develop and commercialize its pan-Janus kinase inhibitor, TD-1473, for the treatment of inflammatory intestinal diseases. A phase II and a phase IIb/III study are likely to be initiated in third and fourth-quarter 2018 to evaluate TD-1473 in Crohn's disease and ulcerative colitis, respectively.
In January, Theravance along with partner Mylan (MYL - Free Report) announced that the new drug application (NDA) for its pipeline candidate, Yupelri (revefenacin) (TD-4208), has been accepted by the FDA for treatment of adults with chronic obstructive pulmonary disease (COPD). A response from the regulatory body is expected on Nov 13, 2018. The company is preparing for the commercial launch of the drug upon potential approval.
An approval will be a huge boost considering that Yupelri will be the first once daily nebulized long-acting muscarinic antagonist (LAMA) option for COPD patients.
In April, Theravance Biopharma highlighted that the FDA has approved a label expansion of Glaxo’s (GSK - Free Report) once-daily, single inhaler triple combination therapy, Trelegy Elipta, to include COPD patients with airflow limitation or those who have experienced an acute worsening of respiratory symptoms. Theravance has 85% economic interest in royalties paid by Glaxo on Trelegy Elipta’s global sales.
In the second quarter of 2018, Glaxo recorded Trelegy Elipta's sales of $36.5 million. While Theravance is eligible to receive 5.5-8.5% (tiered) of the product's worldwide net sales.
A regulatory application has also been submitted by Glaxo to the Japanese Ministry of Health, Labour and Welfare, seeking an approval for Trelegy Ellipta pertaining to the treatment of COPD.
2018 Outlook Reiterated
Theravance continues to expect operating loss excluding non-cash share-based compensation for 2018 in the range of $180-$200 million.
Zacks Rank & Key Picks
Theravance Biopharma carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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