Allos Therapeutics, Inc. (NASDAQ: ALTH), a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics, today reported preliminary and
unaudited 2011 financial highlights and key business priorities in
anticipation of its presentation at the 30th Annual J.P. Morgan
Healthcare Conference on January 11, 2012.
- Net product sales are expected to
approximate $15.4 million for the fourth quarter of 2011,
representing a 17% sequential increase over the third quarter of
2011.
- As of December 31, 2011, the Company
had no debt and $97.8 million in total cash, cash equivalents and
investments.
- The Company plans to report its
complete audited financial results for 2011 in early March
2012.
“In the fourth quarter, we continued to make important progress
with FOLOTYN for patients with relapsed or refractory peripheral
T-cell lymphoma and are pleased with the quarter-over-quarter
revenue growth,” commented Paul L. Berns, president and chief
executive officer of Allos Therapeutics. “We ended 2011 with a
strong balance sheet and remain focused on growing U.S. sales of
FOLOTYN for relapsed or refractory PTCL while prudently managing
our operating expenses. Also, in collaboration with Mundipharma, we
are pursuing regulatory approval for FOLOTYN in the EU and other
ex-U.S. geographies as well as future label expansion opportunities
in T-cell lymphoma.”
Preliminary and Unaudited 2011 Financial Highlights
FOLOTYN® (pralatrexate injection) net product sales for full
year 2011 are expected to approximate $50.5 million, compared to
$35.2 million for 2010. For the fourth quarter of 2011, net product
sales are expected to approximate $15.4 million, a 17% increase
compared to $13.2 million for the third quarter of 2011. When
excluding certain infrequently occurring items, net product sales
for the fourth quarter of 2011 were $11.0 million, an 8% increase
compared to $10.2 million for the third quarter of 2011. These
infrequently occurring items include: (i) $3.0 million in the third
quarter of 2011 relating to the sale of FOLOTYN for use in a
clinical trial to be conducted by a third party, (ii) $3.2 million
in the fourth quarter of 2011 relating to an increase in our
distributors’ year-end 2011 inventory levels as compared to average
inventory levels for 2011, and (iii) $1.2 million in the fourth
quarter of 2011 relating to the release of gross-to-net sales
allowances due to refined estimates.
Financial Guidance
Allos reiterates prior guidance and expects total operating
costs and expenses, excluding cost of sales, cost of license and
other revenue and non-cash stock-based compensation expense, to
approximate $82 to $84 million for 2011. Stock-based compensation
expense for 2011 is expected to approximate $12 million.
Allos expects that license and other revenue and cost of license
and other revenue for the fourth quarter of 2011, related to the
agreement with Mundipharma International Corporation Limited, will
approximate $1.0 million and $0.5 million, respectively. This
guidance relates to expected research and development and
regulatory services to be performed by the Company, and includes
Mundipharma’s current 40% share of jointly agreed-upon clinical
development expenses for FOLOTYN.
As of December 31, 2011, the Company had $97.8 million in total
cash, cash equivalents and investments. The Company expects its
cash position will be sufficient to fund operations through at
least early 2015. This projection is based on certain assumptions
for modeling purposes only (and in the case of future revenue
levels, should not be considered the Company’s financial guidance),
including: (i) future net product sales levels and cost of
sales remaining consistent with our actual results for fiscal year
2011, and (ii) our annual cash-based operating expenditures,
excluding cost of sales, non-cash stock-based compensation and
depreciation expense and net of expected reimbursements from
Mundipharma for jointly funded clinical trials, approximating $72
to $75 million per year for 2012 through 2015.
Growth in U.S. sales and/or potential milestone payments and
royalties associated with regulatory approval of FOLOTYN in the
European Union have the potential to further extend our cash
resources assuming our costs remain consistent with our
projections.
Non-GAAP financial information is utilized by Allos' management
to provide a useful measure of operating performance of the
company. Non-GAAP financial information herein includes the
financial guidance related to projected operating expenditures. We
report the expected reimbursements from Mundipharma as License and
Other Revenue in accordance with generally accepted accounting
principles but have netted such reimbursements against operating
expenditures for purposes of presentation herein. In addition,
guidance for operating costs and expenses excludes cost of sales,
cost of license and other revenue, amortization of intangible asset
and non-cash stock based compensation expense, which is not being
provided at this time.
Key Business Priorities
- Continue to grow U.S. sales of FOLOTYN
for relapsed or refractory PTCL and manage expenses to drive to
future profitability
- Pursue regulatory approval to market
FOLOTYN for relapsed or refractory PTCL in Europe and the rest of
world in collaboration with Mundipharma
- Advance FOLOTYN development program in
hematologic malignancies, including first-line PTCL and relapsed or
refractory cutaneous T-cell lymphoma in collaboration with
Mundipharma
- Explore opportunities to grow product
portfolio revenues through product acquisition and/or in-licensing
that leverages the Company’s existing infrastructure
Presentation to be Webcast
Members of the Company's senior management will present at the
30th Annual J.P. Morgan Healthcare Conference. The presentation
will begin at 10:00 a.m. Pacific Time on Wednesday, January 11,
2012. There will be a live webcast of the presentation, which will
be accessible through a link available on the home page and
investor relations section of the Allos website. In addition, the
webcast will be recorded and available for replay on the Company’s
website for 90 days following January 11, 2012.
About Peripheral T-Cell Lymphoma
T-cell lymphomas account for approximately 10% to 15% of all
cases of non-Hodgkin lymphomas (NHL).1-3 Allos estimates the
current annual incidence of PTCL to be approximately 5,900 patients
in the U.S. and approximately 6,000 to 7,000 patients in the top
five European markets. The outcome of patients with PTCL is poor
and the majority of patients ultimately have refractory disease to
a variety of agents, including multi-agent chemotherapy with CHOP
(cyclophosphamide, doxorubicin, vincristine, and prednisone) or
CHOP-like regimens. The 5-year overall survival rate in these
patients is 25% to 40%, depending on sub-type.4-5
About FOLOTYN
FOLOTYN, a folate analogue metabolic inhibitor, was discovered
by Sloan-Kettering Institute for Cancer Research, SRI International
and Southern Research Institute and developed by Allos
Therapeutics. In September 2009, the U.S. Food and Drug
Administration (FDA) granted accelerated approval for FOLOTYN for
use as a single agent for the treatment of patients with relapsed
or refractory PTCL. This indication is based on overall response
rate. Clinical benefit such as improvement in progression-free
survival or overall survival has not been demonstrated. FOLOTYN has
been available to patients in the U.S. since October 2009. An
updated analysis of data from PROPEL, the pivotal study of FOLOTYN
in patients with relapsed or refractory PTCL, was published in the
March 20, 2011 issue of the Journal of Clinical Oncology. FOLOTYN
has patent protection through 2017, potentially through July 2022,
assuming a five-year patent term extension through the Hatch-Waxman
Act.
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics. Allos is currently focused on
the development and commercialization of FOLOTYN® (pralatrexate
injection), a folate analogue metabolic inhibitor. FOLOTYN is
approved in the U.S. for the treatment of patients with relapsed or
refractory PTCL. For additional information, please visit
www.allos.com.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
FOLOTYN may suppress bone marrow function, manifested by
thrombocytopenia, neutropenia, and anemia. Monitor blood counts and
omit or modify dose for hematologic toxicities.
Mucositis may occur. If greater-than or equal to Grade 2
mucositis is observed, omit or modify dose. Patients should be
instructed to take folic acid and receive vitamin B12 to
potentially reduce treatment-related hematological toxicity and
mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions
may be progressive and increase in severity with further treatment.
Patients with dermatologic reactions should be monitored closely,
and if severe, FOLOTYN should be withheld or discontinued.
Tumor lysis syndrome may occur. Monitor patients and treat if
needed.
FOLOTYN can cause fetal harm. Women should avoid becoming
pregnant while being treated with FOLOTYN and pregnant women should
be informed of the potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to
patients with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require
monitoring. If liver function test abnormalities are greater-than
or equal to Grade 3, omit or modify dose.
Adverse Reactions
The most common adverse reactions were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events are pyrexia, mucositis, sepsis,
febrile neutropenia, dehydration, dyspnea, and
thrombocytopenia.
Use in Specific Patient Population
Nursing mothers should be advised to discontinue nursing or the
drug, taking into consideration the importance of the drug to the
mother.
Drug Interactions
Co-administration of drugs subject to renal clearance (e.g.,
probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result
in delayed renal clearance.
Please see FOLOTYN Full Prescribing Information at
www.FOLOTYN.com.
Safe Harbor Statement
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements include statements regarding the Company’s preliminary
and unaudited financial results for year and quarter ended December
31, 2011, which are preliminary, have not been reviewed by the
Company’s independent registered public accounting firm and are
subject to change; the Company’s financial guidance for 2011;
statements regarding the status and prospects of our
commercialization of FOLOTYN for patients with relapsed or
refractory peripheral T-cell lymphoma, statements regarding our
strategic collaboration with Mundipharma, including Mundipharma’s
potential commercialization of FOLOTYN outside the United States
and Canada, any statements regarding our future financial
performance, results of operations or sufficiency of capital
resources to fund our operating requirements and any other
statements that are other than statements of historical fact. In
some cases, you can identify forward-looking statements by
terminology such as "may," "will," "should," "expects," "intends,"
"plans," "anticipates," "believes," "estimates," "predicts,"
"projects," "potential," "continue," and other similar terminology
or the negative of these terms, but their absence does not mean
that a particular statement is not forward-looking. Such
forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that may cause actual
results to differ materially from those anticipated by the
forward-looking statements. Important factors that may cause actual
results to differ materially include, but are not limited to, risks
and uncertainties associated with the commercialization of FOLOTYN;
the Company’s compliance with applicable regulatory requirements;
that the design of and data collected from the Company’s pivotal
PROPEL trial may not be adequate to demonstrate the safety and
efficacy of FOLOTYN for the treatment of patients with relapsed or
refractory PTCL, or otherwise be sufficient to support EMA
approval; risks and uncertainties relating to the establishment,
implementation and execution of the Company’s strategic
collaboration with Mundipharma, including the parties future
product resources and access to capital to support its future
operations, including its product development and commercialization
plans for FOLOTYN; and other economic, business, competitive and/or
regulatory factors affecting the Company’s business generally.
Additional information concerning these and other factors that may
cause actual results to differ materially from those anticipated in
the forward-looking statements is contained in the "Risk Factors"
section of the Company's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2011, and in the Company's other
periodic reports and filings with the Securities and Exchange
Commission. The Company cautions investors not to place undue
reliance on the forward-looking statements contained in this press
release. All forward-looking statements are based on information
currently available to the Company on the date hereof, and the
Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this presentation, except as required by law.
Note: The Allos logo and FOLOTYN name are registered trademarks
of Allos Therapeutics, Inc.
References:
1. The Non-Hodgkin's Lymphoma Classification Project. A clinical
evaluation of the International Lymphoma Study Group classification
of non-Hodgkin's lymphoma. Blood. 1997;89(11):3909-3908.
2. Hennessy BT, Hanrahan EO, Daly PA. Non-Hodgkin lymphoma: an
update [review]. Lancet Oncol. 2004;5(6):341-353.
3. O'Leary HM, Savage KJ. Novel therapies in peripheral T-cell
lymphomas [review]. Curr Oncol Rep. 2008;134(5):202-207.
4. Savage KJ, Chhanabhai M, Gascoyne RD, et al. Characterization
of peripheral T-cell lymphomas in a single North American
institution by the WHO classification. Ann Oncol
2004;15(10):1467-75.
5. Savage KJ. Peripheral T-cell Lymphomas. Blood Rev. 2007;
21:201-216.
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