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Theravance (TBPH) Earnings & Revenues Miss Estimates in Q2
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Theravance Biopharma, Inc. (TBPH - Free Report) incurred a loss of $1 per share in second-quarter 2020, wider than the Zacks Consensus Estimate of a loss of 95 cents and the year-ago loss of 72 cents as well.
Total revenues of $15 million in the quarter also missed the Zacks Consensus Estimate of $21 million. Revenues declined year over year too, mainly due to lower revenues from the collaboration agreement with Johnson & Johnson (JNJ - Free Report) and the absence of licensing revenues.
The top line comprised collaboration revenues worth $5.5 million from Janssen, a wholly owned subsidiary of J&J, and $9.5 million from the collaboration agreement with Mylan in relation to Yupelri (revefenacin).
Notably, Theravance has a collaboration deal with Mylan for the development and commercialization of Yupelri approved by the FDA in November 2018. The drug is used for maintenance treatment of adults with chronic obstructive pulmonary disease (COPD). Theravance and Mylan formally launched their sales and marketing efforts for Yupelri in early 2019 and the product witnessed a strong initial sales surge thereafter.
Yupelri achieved 91.8% share of the nebulized LAMA market and a 16% share of the long-acting nebulized market as of April 2020. Per the company, despite the pandemic woes, which dwindled overall market demand, Yupelri expanded its market share and witnessed a strong customer acceptance and brand performance across the key market metrics.
However, management believes that Yupelri’s trajectory could be affected by the COVID-19 outbreak during the third quarter of 2020.
Shares of Theravance have declined 19.5% in the year so far compared with the industry’s decrease of 3.8%.
Quarter in Detail
Research & development expenses were $62.4 million, up 34.4% from the year-ago quarter, primarily due to higher external cost pertaining to pipeline development.
Selling, general & administrative expenses rose 11.7% to $24.8 million due to higher share-based compensation and employee-related expenses.
As of Jun 30, 2020, Theravance had cash, cash equivalents, marketable securities worth $438.3 million compared with $492.1 million as of Mar 31, 2020.
Updates on Pipeline
Theravance holds an economic interest in royalties earned from GlaxoSmithKline (GSK - Free Report) on the triple combination COPD treatment Trelegy Ellipta’s global sales. In the second quarter, Glaxo recorded sales worth $241 million from Trelegy Ellipta. Theravance is eligible to receive 5.5-8.5% tiered royalties on the product's worldwide net sales.
In June 2020, Theravance initiated dosing in a phase II study evaluating its lung-selective, nebulized Janus kinase inhibitor (JAKi), TD-0903, for the potential treatment of hospitalized patients with acute lung injury (ALI) caused by COVID-19.
Due to the coronavirus (COVID-19) impact, Theravance continues to expect some delays in its clinical programs and patient enrollment in studies.
The company has a collaboration pact with 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 induction and maintenance study for ulcerative colitis are underway. Data from the phase IIb portion of the ulcerative colitis and phase II Crohn's disease studies is expected in 2021.
Theravance is also developing TD-5202 (gut-selective irreversible JAK3 inhibitor) in a phase I study for addressing inflammatory intestinal diseases. Also, the company is evaluating ampreloxetine (TD-9855) under two phase III programs for treating patients with symptomatic neurogenic orthostatic hypotension (nOH).
It is developing the inhaled, lung-selective pan-Janus kinase (JAK) inhibitor TD-8236 in a phase I study for treating inflammatory lung diseases with minimal systemic exposure.
2020 Outlook
Theravance maintained its financial guidance for 2020.
For the full year, the company anticipates operating loss (excluding non-cash share-based compensation) in the range of $205-$225 million.
Theravance Biopharma, Inc. Price, Consensus and EPS Surprise
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Theravance (TBPH) Earnings & Revenues Miss Estimates in Q2
Theravance Biopharma, Inc. (TBPH - Free Report) incurred a loss of $1 per share in second-quarter 2020, wider than the Zacks Consensus Estimate of a loss of 95 cents and the year-ago loss of 72 cents as well.
Total revenues of $15 million in the quarter also missed the Zacks Consensus Estimate of $21 million. Revenues declined year over year too, mainly due to lower revenues from the collaboration agreement with Johnson & Johnson (JNJ - Free Report) and the absence of licensing revenues.
The top line comprised collaboration revenues worth $5.5 million from Janssen, a wholly owned subsidiary of J&J, and $9.5 million from the collaboration agreement with Mylan in relation to Yupelri (revefenacin).
Notably, Theravance has a collaboration deal with Mylan for the development and commercialization of Yupelri approved by the FDA in November 2018. The drug is used for maintenance treatment of adults with chronic obstructive pulmonary disease (COPD). Theravance and Mylan formally launched their sales and marketing efforts for Yupelri in early 2019 and the product witnessed a strong initial sales surge thereafter.
Yupelri achieved 91.8% share of the nebulized LAMA market and a 16% share of the long-acting nebulized market as of April 2020. Per the company, despite the pandemic woes, which dwindled overall market demand, Yupelri expanded its market share and witnessed a strong customer acceptance and brand performance across the key market metrics.
However, management believes that Yupelri’s trajectory could be affected by the COVID-19 outbreak during the third quarter of 2020.
Shares of Theravance have declined 19.5% in the year so far compared with the industry’s decrease of 3.8%.
Quarter in Detail
Research & development expenses were $62.4 million, up 34.4% from the year-ago quarter, primarily due to higher external cost pertaining to pipeline development.
Selling, general & administrative expenses rose 11.7% to $24.8 million due to higher share-based compensation and employee-related expenses.
As of Jun 30, 2020, Theravance had cash, cash equivalents, marketable securities worth $438.3 million compared with $492.1 million as of Mar 31, 2020.
Updates on Pipeline
Theravance holds an economic interest in royalties earned from GlaxoSmithKline (GSK - Free Report) on the triple combination COPD treatment Trelegy Ellipta’s global sales. In the second quarter, Glaxo recorded sales worth $241 million from Trelegy Ellipta. Theravance is eligible to receive 5.5-8.5% tiered royalties on the product's worldwide net sales.
In June 2020, Theravance initiated dosing in a phase II study evaluating its lung-selective, nebulized Janus kinase inhibitor (JAKi), TD-0903, for the potential treatment of hospitalized patients with acute lung injury (ALI) caused by COVID-19.
Due to the coronavirus (COVID-19) impact, Theravance continues to expect some delays in its clinical programs and patient enrollment in studies.
The company has a collaboration pact with 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 induction and maintenance study for ulcerative colitis are underway. Data from the phase IIb portion of the ulcerative colitis and phase II Crohn's disease studies is expected in 2021.
Theravance is also developing TD-5202 (gut-selective irreversible JAK3 inhibitor) in a phase I study for addressing inflammatory intestinal diseases. Also, the company is evaluating ampreloxetine (TD-9855) under two phase III programs for treating patients with symptomatic neurogenic orthostatic hypotension (nOH).
It is developing the inhaled, lung-selective pan-Janus kinase (JAK) inhibitor TD-8236 in a phase I study for treating inflammatory lung diseases with minimal systemic exposure.
2020 Outlook
Theravance maintained its financial guidance for 2020.
For the full year, the company anticipates operating loss (excluding non-cash share-based compensation) in the range of $205-$225 million.
Theravance Biopharma, Inc. Price, Consensus and EPS Surprise
Theravance Biopharma, Inc. price-consensus-eps-surprise-chart | Theravance Biopharma, Inc. Quote
Zacks Rank
Theravance currently 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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