We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Theravance (TBPH) Q1 Loss Widens, Revenues Miss Estimates
Read MoreHide Full Article
Theravance Biopharma, Inc. (TBPH - Free Report) incurred a loss of $1.32 per share in first-quarter 2019, wider than the Zacks Consensus Estimate of a loss of $1.18 as well as the year-ago loss of $1.22.
Total revenues of $5.3 million in the quarter significantly missed the Zacks Consensus Estimate of $16.45 million. Moreover, revenues dropped 36.1% year over year due to no product sales in the quarter.
Last November, 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 first quarter of 2019.
The entire revenues comprised collaboration revenues from partner Johnson & Johnson (JNJ - Free Report) for the joint development of the company’s pan-Janus kinase inhibitor, TD-1473, to treat inflammatory intestinal diseases. Collaboration revenues were $4.6 million in the year-earlier quarter.
Shares of Theravance have lost 4.5% in the year so far versus the industry’s rally of 10.6%.
Research and development expenses were $53.8 million, up 12.8% from the year-ago quarter, primarily due to higher costs to support key programs and higher employee related expenses.
Selling, general & administrative expenses inched up 2% to $25.2 million due to increased collaboration expenses related to the launch activities of Yupelri.
Product and Pipeline Updates
Theravance has collaborated with Mylan for the development and commercialization of Yupelri (revefenacin) pertaining to the maintenance treatment of adults with chronic obstructive pulmonary disease (COPD), which was approved by the FDA last November.
On first-quarter conference call, management stated that Theravance and Mylan formally launched the sales and marketing efforts of Yupelri in early 2019. These include physicians, pharmacists, respiratory therapists and other health care prescribers.
Notably, Theravance has an economic interest in royalties earned from GlaxoSmithKline (GSK - Free Report) on Trelegy Ellipta’s global sales. Trelegy Ellipta, a triple combination therapy of inhaled corticosteroid (ICS)/LAMA/LABA (fluticasone furoate/umeclidinium/vilanterol 'FF/UMEC/VI'), was approved in September 2017 as a maintenance treatment for COPD patients, who are not adequately treated by a combination of ICS and LABA.
In the first quarter of 2019, Glaxo recorded sales of $112.7 million for Trelegy Ellipta. Theravance is eligible to receive 5.5-8.5% (tiered) of the product's worldwide net sales.
The company is currently enrolling patients in the phase II study on TD-1473 for treating Crohn's disease and in the phase IIb/III study for ulcerative colitis.
Theravance is evaluating ampreloxetine (TD-9855) in a phase III program for treating patients with symptomatic neurogenic orthostatic hypotension (nOH). The company plans to present 5-month data from the completed phase II investigation for the given patient population at a medical meeting in June 2019.
Theravance is also developing inhaled, lung-selective pan-Janus kinase (JAK) inhibitor, TD-8236, in a phase I study to assess its potential 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 previously issued guidance.
Theravance Biopharma, Inc. Price, Consensus and EPS Surprise
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
Image: Bigstock
Theravance (TBPH) Q1 Loss Widens, Revenues Miss Estimates
Theravance Biopharma, Inc. (TBPH - Free Report) incurred a loss of $1.32 per share in first-quarter 2019, wider than the Zacks Consensus Estimate of a loss of $1.18 as well as the year-ago loss of $1.22.
Total revenues of $5.3 million in the quarter significantly missed the Zacks Consensus Estimate of $16.45 million. Moreover, revenues dropped 36.1% year over year due to no product sales in the quarter.
Last November, 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 first quarter of 2019.
The entire revenues comprised collaboration revenues from partner Johnson & Johnson (JNJ - Free Report) for the joint development of the company’s pan-Janus kinase inhibitor, TD-1473, to treat inflammatory intestinal diseases. Collaboration revenues were $4.6 million in the year-earlier quarter.
Shares of Theravance have lost 4.5% in the year so far versus the industry’s rally of 10.6%.
Research and development expenses were $53.8 million, up 12.8% from the year-ago quarter, primarily due to higher costs to support key programs and higher employee related expenses.
Selling, general & administrative expenses inched up 2% to $25.2 million due to increased collaboration expenses related to the launch activities of Yupelri.
Product and Pipeline Updates
Theravance has collaborated with Mylan for the development and commercialization of Yupelri (revefenacin) pertaining to the maintenance treatment of adults with chronic obstructive pulmonary disease (COPD), which was approved by the FDA last November.
On first-quarter conference call, management stated that Theravance and Mylan formally launched the sales and marketing efforts of Yupelri in early 2019. These include physicians, pharmacists, respiratory therapists and other health care prescribers.
Notably, Theravance has an economic interest in royalties earned from GlaxoSmithKline (GSK - Free Report) on Trelegy Ellipta’s global sales. Trelegy Ellipta, a triple combination therapy of inhaled corticosteroid (ICS)/LAMA/LABA (fluticasone furoate/umeclidinium/vilanterol 'FF/UMEC/VI'), was approved in September 2017 as a maintenance treatment for COPD patients, who are not adequately treated by a combination of ICS and LABA.
In the first quarter of 2019, Glaxo recorded sales of $112.7 million for Trelegy Ellipta. Theravance is eligible to receive 5.5-8.5% (tiered) of the product's worldwide net sales.
The company is currently enrolling patients in the phase II study on TD-1473 for treating Crohn's disease and in the phase IIb/III study for ulcerative colitis.
Theravance is evaluating ampreloxetine (TD-9855) in a phase III program for treating patients with symptomatic neurogenic orthostatic hypotension (nOH). The company plans to present 5-month data from the completed phase II investigation for the given patient population at a medical meeting in June 2019.
Theravance is also developing inhaled, lung-selective pan-Janus kinase (JAK) inhibitor, TD-8236, in a phase I study to assess its potential 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 previously issued guidance.
Theravance Biopharma, Inc. Price, Consensus and EPS Surprise
Theravance Biopharma, Inc. Price, Consensus and EPS Surprise | Theravance Biopharma, Inc. Quote
Zacks Rank
Theravance currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>