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发帖数: 610 | 1 税收五年一直处于增长状态...cash充足，我觉得风险相对于BPAX小一些
James S. J. Manuso
Thank you, Tim. Good afternoon, and thank you for joining us for Astex
Pharmaceuticals 2012 First Quarter Conference Call. During the quarter, we
made considerable operational progress on many fronts in discovery, research
and in the clinical and regulatory development of our drugs. Our balance
sheet remains sound and our financial performance was excellent. We ended
the quarter with $126 million in cash and marketable securities and we
posted net income of $4.2 million. Dacogen royalty revenue rose to $20.6
million in the first quarter, representing an increase of approximately 21%
from the prior year. We're maintaining fiscal year 2012 royalty guidance of
up to $67 million.
Last month, our Dacogen partner Eisai received a complete response letter
from the U.S. FDA to respond to the application for approval of Dacogen in
elderly acute myeloid leukemia or AML. The FDA declined to approve the
application. While we're disappointed with the agency's decision, in the
second half of this year, the European Medicines Agency, or EMA, will rule
on Eisai's sublicensee Janssen-Cilag's Marketing Authorization Application,
or MAA, for Dacogen in elderly AML. The FDA and EMA drug review and approval
processes are not the same. Historically, there have been applications
which one agency has approved and the other has not approved. It is
important to note that there is currently no approved therapy for elderly
AML patients in any jurisdiction worldwide. Clinical data from SGI-110, our
second-generation hypomethylating agent, a follow-on drug to Dacogen, was
presented earlier this month at an oral presentation at the American
Association for Cancer Research or AACR Meeting. A joint media forum was
also held with Stand Up To Cancer, the foundation that is providing funding
for the Epigenetics Dream Team, the team that has been collaborating with
Astex on scientific and clinical studies of SGI-110. The data presented at
AACR confirmed a favorable pharmacokinetic profile of subcutaneous SGI-110.
It has a half-life of the active decitabine levels that is up to 4x longer
than what is achieved with Dacogen IV infusions. There was excellent
hypomethylation in the daily treatment regimen and preliminary complete
responses or CRs have been observed and relapsed in refractory AML patients.
These responses were evident in those AML patients who achieved the
greatest hypomethylation, demonstrating that greater degrees of
hypomethylation induced by SGI-110 were correlated with disease response.
This correlation is exactly what our clinical researchers sought. SGI-110
will soon begin the Phase II dose expansion stage of the trial in patients
with MDS or AML. We expect to have a clinical data update from the ongoing
SGI-110 study by December in time for the American Society of Hematology or
ASH meeting. Our next stage of the SGI-110 program is to test the drug in
solid tumors. We are on schedule to initiate this stage of SGI-110's
clinical development in the third quarter of 2012. Our HSP90 inhibitor
AT13387 in combination with amuvatinib is progressing in a Phase II trial in
patients with tyrosine kinase inhibitor-resistant gastrointestinal stromal
tumors or GIST tumors. Data from 2 Phase I trials of AT13387 will be
presented at the American Society of Clinical Oncology or ASCO conference in
June.
In the third quarter, we will expand the clinical program of AT13387 to
explore its use in multiple solid tumors. Amuvatinib, or MP470, is
continuing to accrue patients in an international Phase II clinical proof-of
-concept trial in patients with small cell lung cancer. Preliminary results
are expected in the fourth quarter. AT7519, our drug that inhibits multiple
cyclin-dependent kinases, or CDKs, is in a Phase II trial in combination
with bortezomib in patients with multiple myeloma. The National Cancer
Institute of Canada's clinical trials group will initiate 2 new Phase II
trials, one in patients with chronic lymphocytic leukemia or CLL and another
in patients with mantle cell leukemia or MCL by mid-year.
Our kinase inhibitor, AT9283 has been found to inhibit the activity of
oncogenes Aurora A and B and JAK2. Ongoing trials are in multiple myeloma
and in pediatric tumors.
Our preclinical programs are productive. For example, at the recent European
Association for the Study of the Liver or EASL meeting, Astex presented
data on AT26893, a novel first-in-class direct-acting antiviral agent
against the hepatitis C virus or HCV. AT26893 binds to a novel allosteric
site on the full-length helicase protease complex of HCV. Compounds binding
at this site have a novel mode of action and a different resistance profile
compared to active site protease inhibitors. AT26893 is in preclinical
development in preparation for an IND filing.
At this time, I will turn the call over to Michael Molkentin, our Chief
Financial Officer. Michael will provide details on our 2012 first quarter
financial results, as well as provide an update on fiscal guidance for 2012.
Michael?
Michael Molkentin
Thank you very much, Jim. We are pleased with our first quarter operating
performance. We were profitable and we continue to have a strong financial
position. I would also like to remind the listeners on today's call that the
acquisition of our U.K. discovery operation was completed during July 2011
and is, therefore, included in our 2012 first quarter operating and
financial results but is not reflected in the same prior year quarterly
period.
Total revenues for the 2012 first quarter were $22 million compared with $17
.1 million for the same prior year period. Total revenues for the 2012 first
quarter include royalty revenue of $20.6 million compared with $17 million
for the same prior year quarterly period. Our royalty revenue is earned
pursuant to our worldwide license agreement for Dacogen and is generally
received -- recognized when received. Total revenues for the 2012 first
quarter also include development and license revenue of $1.4 million
compared with $127,000 for the same prior year period. The increase in
development and license revenue for the 2012 first quarter is due to the
accelerated recognition earlier in the quarter of all remaining deferred
revenue resulting from the transfer to GSK of existing research work and
assets generated under the former client collaboration. The transfer of this
program arose from the review and rationalization of the company's internal
pipeline and drug discovery programs as part of the prior year acquisition.
Total operating expenses for the 2012 first quarter were $20.6 million
compared with $11.6 million for the same prior year period. The primary
reasons for the increase in total operating expenses for the 2012 first
quarter when compared with the same prior year quarterly period are the
consolidation of research and development and general and administrative
expenses related to the acquisition of Astex Therapeutics Limited,
increasing research and development activities for our programs associated
with SGI-110, AT13387 and amuvatinib and an expense for amortization of
intangible assets. For the 2012 first quarter the noncash expense for
amortization of intangible assets was $2.2 million. We had no similar
expense for the same prior year period. While stock-based compensation
expense, also a noncash charge, was $765,000 for the 2012 first quarter
compared with $712,000 for the same prior year period.
The company reported net income for the 2012 first quarter of $4.2 million
or $0.05 per basic and $0.04 per diluted share compared with net income of $
5.5 million or $0.09 per basic and diluted share for the same prior year
period. The net income for the 2012 first quarter included an income tax
benefit of $2.8 million compared with an income tax provision of $44,000 for
the same prior year period. The income tax benefit for the 2012 first
quarter was primarily due to the recognition of the tax benefit associated
with the amortization of deferred tax liabilities resulting from the
acquisition and the utilization of a foreign research and development tax
credit related to the U.K. subsidiary.
As previously indicated, the company continues to report a strong financial
position. At March 31, 2012, we had approximately $126 million in
unrestricted cash, cash equivalents and current and noncurrent marketable
securities compared to approximately $128 million at December 31, 2011. The
company's financial guidance for 2012 remained substantially unchanged from
our previous guidance. We continue to anticipate royalty revenue will
increase up to 10% from the prior year to a range from $64 million to $67
million. Development and license revenue remains at $1.4 million for 2012.
Though we anticipate earning additional development and license revenue from
our partner programs, we do not guide to such revenue due to the general
uncertainty around and timing of milestone achievements and payments.
The last remaining payment of $700,000 relating to the sale of our
commercial franchise during 2007 will be classified as a gain on sale of
products and is expected to be received during our 2012 second quarter.
Research and development expenses remain unchanged and are expected to
increase from the prior year to a range from $62 million to $67 million.
Amortization of intangible assets, a noncash charge, has been revised upward
from a prior estimate of $7.6 million to $8.5 million for the year. General
and administrative expenses remain unchanged and are expected to decrease
from the prior year to a range from $14 million to $15 million.
Our estimated income tax benefit associated primarily with the amortization
of deferred tax liabilities resulting from the acquisition and a foreign
research and development tax credit related to the U.K. subsidiary has been
revised upward from a prior guidance and is now anticipated to be in the
range from $5 million to $6 million for 2012. The forecasted net loss for
2012 remains unchanged and is expected to be in a range from $13 million to
$15 million for the year. In addition to the amortization of intangible
assets included in total operating expenses are other recurring noncash
operating charges such as stock-based compensation expense and depreciation
that are estimated at $3.5 million for 2012. We continue to estimate that
our average annual shares outstanding used for calculating per share results
for 2012 will be approximately 93 million common shares.
This concludes the review of our financial results for the 2012 first
quarter and comments on our updated annual financial guidance for 2012. I
will now turn the call back to Dr. Manuso for closing remarks.
James S. J. Manuso
Thank you, Michael. Astex is a self-financed company with a strong balance
sheet, a deep proprietary pipeline and multiple partnerships. In the first
quarter, we achieved profitability and we made progress on key programs.
2012 promises to be a signal year for Astex. We await the upcoming European
Medicines Authority decision on Janssen's Marketing Authorization
Application on Dacogen and elderly AML expected in the second half of 2012.
We are planning a number of clinical data presentations at ASCO, ASH and
other scientific conferences.
During our fourth quarter, 4 of our Phase II clinical stage drugs will yield
readouts. Operationally, we continue to expect to be at or near cash flow
neutrality for 2012. For those of you who have not had the opportunity to
access our Analyst Day presentation and accompanying PowerPoint, it is
available on our website. This presentation will give you an in-depth
perspective on our company's business and programs. We look forward to
updating you in the months ahead and at our annual stockholders meeting. Dr.
Harren Jhoti, Dr. Mohammed Azab, Dr. Martin Buckland, Michael Molkentin,
Timothy Enns and I are now ready to answer your questions. Operator, we will
take questions at this time. |
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