Theravance Biopharma, Inc. TBPH incurred a loss of 72 cents per share in second-quarter 2019, narrower than the Zacks Consensus Estimate of a loss of $1.22 but wider than the year-ago quarter’s loss of 76 cents.
Total revenues of $26.2 million in the quarter exceeded the Zacks Consensus Estimate of $14 million. Revenues also increased 11.5% year over year. The increase was mainly due to licensing revenues of $18.5 million received from Mylan as an upfront payment related to the expansion of their present development and commercialization agreement for Yupelri to include China and certain adjacent territories.
In November 2018, Theravance completed the sale of its only marketed drug, Vibativ, to Cumberland Pharmaceuticals. As a result, the company was not able to generate any revenues from product sales in the second quarter of 2019. Collaboration revenues were $7.7 million in the quarter.
Shares of Theravance have lost 18.5% in the year so far versus the industry’s growth of 7.8%.
Research & development expenses were $46.4 million, down 4.5% from the year-ago quarter, primarily due to lower employee-related expenses and a decrease in share-based compensation.
Selling, general & administrative expenses declined 11.2% to $22.2 million due to lower Vibativ-related external expenses and lower share-based compensation.
Product & Pipeline Updates
Theravance has collaborated with Mylan MYL for the development and commercialization of Yupelri (revefenacin) as the maintenance treatment for adults with chronic obstructive pulmonary disease (COPD), which was approved by the FDA last November.
The company stated that, in the second quarter, Yupelri witnessed strong customer acceptance and brand performance across key market metrics.
Notably, Theravance has an economic interest in royalties earned from GlaxoSmithKline GSK on triple combination COPD treatment Trelegy Ellipta’s global sales. In the second quarter of 2019, Glaxo recorded sales of 151.4 millionfrom Trelegy Ellipta. Theravance is eligible to receive 5.5-8.5% (tiered) of the product's worldwide net sales.
The company also has a collaboration agreement with Johnson & Johnson’s JNJ subsidiary, Janssen, to develop its JAK inhibitor, TD-1473, for the treatment of inflammatory intestinal diseases. A phase II study on TD-1473 for treating Crohn's disease and a phase IIb/III study for ulcerative colitis are ongoing.
Theravance is evaluating ampreloxetine (TD-9855) in a phase III program for treating patients with symptomatic neurogenic orthostatic hypotension (nOH).
The company is also developing inhaled, lung-selective pan-Janus kinase (JAK) inhibitor, TD-8236, in a phase I study for the treatment of various serious respiratory diseases. The company plans to provide the biomarker data of TD-8236 in the third quarter of 2019 after evaluating healthy volunteers and asthma patients.
2019 Outlook
For 2019, Theravance anticipates operating loss excluding non-cash share-based compensation to be $210-$230 million, unchanged from the previous guidance.
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