Theravance Remains Neutral - Analyst Blog
March 30 2011 - 5:30AM
Zacks
We are maintaining our Neutral recommendation on
Theravance, Inc. (THRX) with a target price of
$25.00 after the company's fourth quarter and fiscal year 2010
financial results.
Theravance’s fourth quarter 2010 loss per share of 25 cents was
narrower than both the Zacks Consensus Estimate for a loss of
28 cents and the year-ago loss of 35 cents per share. The earnings
improvement was driven by a better top-line performance and lower
research and development costs.
Revenue at Theravance increased more than 80% over the prior
year to $6.9 million. Revenue was also slightly above the Zacks
Consensus Revenue Estimate of $6 million.
Theravance has active collaborations with
GlaxoSmithKline (GSK) for the Relovair, LAMA/LABA
(also called 719/VI) and MABA programs. The Relovair program holds
the biggest potential in the company’s pipeline, which aims to
replace one of Glaxo’s best selling drugs, Advair. It is being
developed for the treatment of chronic obstructive pulmonary
diseases (COPD) and asthma.
The LAMA/LABA combination is also being developed for the
treatment of COPD. Under the MABA collaboration, Theravance is
making rapid progress with GSK961081, which could be another
important option for the treatment of COPD. This portfolio of
respiratory products could put Theravance in a very competitive
position if successful.
Theravance is entitled to receive royalties on sales of
Relovair, LABA/LAMA, and MABA without any cost obligations. We
believe the revenue generated following the approval of any of the
programs will ultimately lead the company to profitability.
On its own, Theravance has a deep pipeline consisting of
candidates like TD-5108 (chronic constipation), TD-1792 (cSSSI),
and TD-1211 (opioid-induced constipation), which could boost future
revenues. All these programs are solely owned by Theravance and it
is looking for collaboration partners for the development and
commercialization of these compounds.
Theravance’s lead drug, Vibativ (telavancin), is an injectable
antibiotic approved for the treatment of complicated skin and skin
structure infections (cSSSI) caused by gram-positive bacteria,
including resistant pathogens such as methicillin-resistant
staphylococcus aureus (MRSA). Vibativ is being marketed and sold by
Astellas, while Theravance receives royalties, ranging from high
teens to upper twenties depending on sales volume. The US Food and
Drug Administration (FDA) approval to market Vibativ is a
significant achievement for the company and will provide Theravance
with much-needed funds.
Vibativ is also being studied for hospital-acquired pneumonia
(HAP) or nosocomial pneumonia (NP). However, Theravance received a
complete response letter (CRL) for the NP indication from the FDA
requesting for additional data. The company is currently in
discussions with the FDA and has no plans to conduct additional
studies. We are disappointed with this regulatory setback suffered
by Vibativ for the treatment of HAP.
In addition, we are concerned about competition from other drugs
targeting gram-positive bacterial infections. Vibativ is competing
with products like
ViroPharma’s(VPHM) Vancocin,
Cubist Pharmaceutical’s (CBST) Cubicin, and
Pfizer’s (PFE) Xyvox and Tygacil. Additionally,
the October 2010 approval of Forest Laboratories’
(FRX) Teflaro has intensified the competition for Vibativ.
Consequently, we apprehend that Vibativ’s initial sales ramp would
be slow.
CUBIST PHARM (CBST): Free Stock Analysis Report
FOREST LABS A (FRX): Free Stock Analysis Report
GLAXOSMITHKLINE (GSK): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
THERAVANCE INC (THRX): Free Stock Analysis Report
VIROPHARMA (VPHM): Free Stock Analysis Report
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