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Theravance (TBPH) Q4 Loss Wider than Expected, Revenues Beat
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Theravance Biopharma, Inc. (TBPH - Free Report) reported fourth-quarter 2016 loss of $1.36 per share, much wider than both the Zacks Consensus Estimate of a loss of $1.07 and the year-ago loss of $1.23.
The Theravance stock underperformed the Zacks classified Medical-Drugs industry year to date. The company’s shares gained 0.3%, whereas the industry registered an increase of 6.1%.
Total revenue in the quarter surged 46.2% year over year to $5.7 million mostly from U.S. net product sales of Vibativ (telavancin). Reported revenues beat the Zacks Consensus Estimate by 14%.
Quarterly Details
Theravance’s sole marketed product, Vibativ, generated U.S. revenues of $5 million in the fourth quarter, up 27.5% from the year-ago period. However, the figure decreased 28.2% sequentially due to the impact of seasonality.
Revenues from collaborations were $0.66 million compared with $0.2 million in the year-ago quarter.
Research and development expenses were $42 million, up 29.6% from the year-ago period. This was mainly due costs associated with the advancement of the company’s priority pipeline programs.
Selling, general & administrative expenses, on the other hand, declined 15.4% to $20.4 million. This was primarily due to lower costs associated with share-based compensation expenses and lower external sales and marketing expenses.
2016 Results
Full-year sales increased 15.4% year over year to $48.6 million. Sales narrowly beat the Zacks Consensus Estimate of $48.3 million.
Full-year loss of $4.26 per share was significantly wider than Zacks Consensus Estimate of a loss of $3.78. The company had posted loss of $5.34 per share a year ago.
2017 Outlook
Theravance expects operating loss (excluding share-based compensation) in the range of $195.0 to $205.0 million in 2017.
Pipeline Update
Theravance has made significant progress with its pipeline. In Oct 2016, Theravance and partner Mylan N.V. announced positive top-line data from two replicate three-month phase III studies evaluating revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD).
Data showed that the studies met primary efficacy endpoints, demonstrating statistically significant and clinically meaningful improvements over placebo in trough lung function after 12 weeks of dosing for both the 88 mcg once-daily and 175 mcg once-daily of revefenacin. Both the doses of the candidate were found to be generally well-tolerated in the studies.
In addition to the two efficacy studies, the phase III program includes an ongoing 12-month, open-label, active comparator safety study, which is expected to be completed in mid-2017. Positive data from the safety study would allow Theravance to file a new drug application (NDA) for revefenacin in the U.S. by the end of 2017.
Also, the company is planning to initiate a phase IIIb study of revefenacin in patients with low peak inspiratory flow rate (PIFR) in 2017.
Furthermore, Theravance is working on expanding Vibativ’s label. The company is evaluating Vibativ in a phase III (TOUR) study for the treatment of primary bacteremia. The study expected to be complete in 2018. In Jan 2017, the company announced positive interim data from the study evaluating how Vibativ is used to treat patients with bacteremia or infective endocarditis (IE). The study demonstrated positive clinical responses (cure or improvement leading to step-down oral therapy) in 64.4% of patients. The remaining 6.7% of patients failed treatment and 28.9% were considered non-evaluable.
With a number of updates expected on the pipeline front over the upcoming quarters, we expect investor focus to remain on the company.
Theravance Biopharma, Inc. Price, Consensus and EPS Surprise
Theravancecurrently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Celgene Corporation and Sunesis Pharmaceuticals, Inc. . Each of these stocks carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Celgene’s earnings estimates increased from $6.55 to $6.60 for 2017 and from $8.13 to $8.16 for 2018 over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 5.08%.
Sunesis’ loss estimates narrowed from $2.57 to $2.44 for 2016 and from $2.16 to $1.97 for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 0.54%.
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Theravance (TBPH) Q4 Loss Wider than Expected, Revenues Beat
Theravance Biopharma, Inc. (TBPH - Free Report) reported fourth-quarter 2016 loss of $1.36 per share, much wider than both the Zacks Consensus Estimate of a loss of $1.07 and the year-ago loss of $1.23.
The Theravance stock underperformed the Zacks classified Medical-Drugs industry year to date. The company’s shares gained 0.3%, whereas the industry registered an increase of 6.1%.
Total revenue in the quarter surged 46.2% year over year to $5.7 million mostly from U.S. net product sales of Vibativ (telavancin). Reported revenues beat the Zacks Consensus Estimate by 14%.
Quarterly Details
Theravance’s sole marketed product, Vibativ, generated U.S. revenues of $5 million in the fourth quarter, up 27.5% from the year-ago period. However, the figure decreased 28.2% sequentially due to the impact of seasonality.
Revenues from collaborations were $0.66 million compared with $0.2 million in the year-ago quarter.
Research and development expenses were $42 million, up 29.6% from the year-ago period. This was mainly due costs associated with the advancement of the company’s priority pipeline programs.
Selling, general & administrative expenses, on the other hand, declined 15.4% to $20.4 million. This was primarily due to lower costs associated with share-based compensation expenses and lower external sales and marketing expenses.
2016 Results
Full-year sales increased 15.4% year over year to $48.6 million. Sales narrowly beat the Zacks Consensus Estimate of $48.3 million.
Full-year loss of $4.26 per share was significantly wider than Zacks Consensus Estimate of a loss of $3.78. The company had posted loss of $5.34 per share a year ago.
2017 Outlook
Theravance expects operating loss (excluding share-based compensation) in the range of $195.0 to $205.0 million in 2017.
Pipeline Update
Theravance has made significant progress with its pipeline. In Oct 2016, Theravance and partner Mylan N.V. announced positive top-line data from two replicate three-month phase III studies evaluating revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD).
Data showed that the studies met primary efficacy endpoints, demonstrating statistically significant and clinically meaningful improvements over placebo in trough lung function after 12 weeks of dosing for both the 88 mcg once-daily and 175 mcg once-daily of revefenacin. Both the doses of the candidate were found to be generally well-tolerated in the studies.
In addition to the two efficacy studies, the phase III program includes an ongoing 12-month, open-label, active comparator safety study, which is expected to be completed in mid-2017. Positive data from the safety study would allow Theravance to file a new drug application (NDA) for revefenacin in the U.S. by the end of 2017.
Also, the company is planning to initiate a phase IIIb study of revefenacin in patients with low peak inspiratory flow rate (PIFR) in 2017.
Furthermore, Theravance is working on expanding Vibativ’s label. The company is evaluating Vibativ in a phase III (TOUR) study for the treatment of primary bacteremia. The study expected to be complete in 2018. In Jan 2017, the company announced positive interim data from the study evaluating how Vibativ is used to treat patients with bacteremia or infective endocarditis (IE). The study demonstrated positive clinical responses (cure or improvement leading to step-down oral therapy) in 64.4% of patients. The remaining 6.7% of patients failed treatment and 28.9% were considered non-evaluable.
With a number of updates expected on the pipeline front over the upcoming quarters, we expect investor focus to remain on the company.
Theravance Biopharma, Inc. Price, Consensus and EPS Surprise
Theravance Biopharma, Inc. Price, Consensus and EPS Surprise | Theravance Biopharma, Inc. Quote
Zacks Rank & Key Picks
Theravancecurrently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Celgene Corporation and Sunesis Pharmaceuticals, Inc. . Each of these stocks carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Celgene’s earnings estimates increased from $6.55 to $6.60 for 2017 and from $8.13 to $8.16 for 2018 over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 5.08%.
Sunesis’ loss estimates narrowed from $2.57 to $2.44 for 2016 and from $2.16 to $1.97 for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 0.54%.
A Full-Blown Technological Breakthrough in the Making
Zacks’ Aggressive Growth Strategist Brian Bolan explores autonomous cars in our latest Special Report, Driverless Cars: Your Roadmap to Mega-Profits Today. In addition to who will be selling them and how the auto industry will be impacted, Brian reveals 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>