Neutral on Theravance - Analyst Blog
August 17 2011 - 12:52PM
Zacks
We have maintained our Neutral recommendation on
Theravance, Inc. (THRX) with a target price of
$21.00 per share following the announcement of second quarter 2011
financial results.
Theravance’s second quarter 2011 loss per share of 31 cents was
wider than the Zacks Consensus Estimate of a loss of 26 cents as
well as the year-ago loss of 28 cents per share. The wider loss was
attributable to a flat top-line performance as well as increased
research and development (R&D) expenses.
Revenue at Theravance was almost flat over the prior year at
$6.4 million due to light royalty revenue from Vibativ sales in the
reported quarter. Revenue was also much below the Zacks Consensus
Estimate of $9 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.
If successful, this portfolio of respiratory products could put
Theravance in a very competitive position. Theravance is entitled
to receive royalties on sales of drugs developed from the Relovair,
LABA/LAMA, and MABA studies without any added cost obligations. We
believe the revenue generated following the approval of any of the
programs will ultimately lead the company to profitability.
Theravance, on its own, has a deep pipeline consisting of
candidates like TD-5108 (chronic constipation), TD-1792 (cSSSI),
and TD-1211 (opioid-induced constipation), which could drive future
revenues. Theravance, the sole owner of all these promising
programs, is on the lookout of collaborative partners for the
development and commercialization of the 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. We believe the royalties on Vibativ
sales provide Theravance with some much-needed funds.
Vibativ is also being studied for hospital-acquired pneumonia
(HAP) or nosocomial pneumonia (NP). Though the antibiotic has not
been approved for NP in either Canada or the US, the drug received
a positive opinion from the Committee for Medicinal Products for
Human Use (CHMP), in the EU, for the NP indication in late May
2011.
If approved, this will be the first approval for the treatment
of NP, which is associated with high mortality rates. In the US,
Theravance received a complete response letter (CRL) for NP with
the FDA requesting for additional data.
The company is currently in discussions with the FDA and has no
plans to conduct additional studies. Though we are encouraged by
the positive CHMP opinion, we are disappointed with the CRL
received in the US.
In addition, we are concerned about competition from other drugs
targeting gram-positive bacterial infections. Vibativ is competing
with ViroPharma’s (VPHM) Vancocin, Cubist
Pharmaceutical’s (CBST) Cubicin, Pfizer’s
(PFE) Xyvox and Tygacil and Forest Laboratories’
(FRX) Teflaro. Consequently, we apprehend that Vibativ’s initial
sales ramp would be slow. We, therefore, prefer to remain on the
sidelines on the stock.
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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