Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported financial
results for the three months ended September 30, 2011.
- FOLOTYN® (pralatrexate injection) net
product sales increased 61% year-over-year to $13.2 million in the
third quarter of 2011, compared to $8.2 million for the same period
in 2010.
- As of September 30, 2011, the Company
had no debt and $100.4 million in total cash, cash equivalents and
investments.
“We believe our achievement of significant year-over-year
revenue growth reflects increased disease-state awareness and brand
awareness of FOLOTYN for patients with relapsed or refractory
peripheral T-cell lymphoma, for whom there remains an unmet need,”
commented Paul L. Berns, president and chief executive officer of
Allos Therapeutics. “We ended the third quarter 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 in the EU, which may occur in early
2012, as well as future label expansion opportunities in T-cell
lymphoma.”
Financial Results
Net product sales for the three months ended September 30, 2011,
were $13.2 million, compared to $8.2 million for the same period in
2010, a 61% increase year-over-year. Net product sales for the nine
months ended September 30, 2011, were $35.1 million, compared to
$23.5 million for the same period in 2010, a 49% increase
year-over-year. Net product sales for the three and nine months
ended September 30, 2011 include $3.0 million related to the sale
of FOLOTYN for use in a clinical trial to be conducted by an
unrelated party. Allos expects to generate future sales of FOLOTYN
related to this clinical trial, however, Allos cannot predict the
timing or amount of such future sales.
In May 2011, Allos entered into a strategic collaboration
agreement with Mundipharma International Corporation Limited
(Mundipharma) and received an upfront payment of $50 million.
License and other revenue related to the Mundipharma agreement for
the three and nine months ended September 30, 2011 were $1.0
million and $29.1 million, respectively. As of September 30, 2011,
$21.3 million was recorded as deferred revenue related to the
Mundipharma agreement.
Cost of sales for the three and nine months ended September 30,
2011, were $1.2 million and $3.2 million, respectively, or
approximately 9% of net product sales. These amounts compared to
$0.9 million and $2.3 million for the same periods in 2010.
Cost of license and other revenue for the three and nine months
ended September 30, 2011 were $0.4 million and $11.0 million,
respectively. The amount recorded for the nine months ended
September 30, 2011 was primarily related to the Company's payment
of $10 million (or 20% of the $50 million upfront payment the
Company received from Mundipharma) to the licensors of FOLOTYN
under the terms of the Company's license agreement with Sloan
Kettering Institute for Cancer Research, SRI International, and
Southern Research Institute.
Total operating costs and expenses, excluding cost of sales,
cost of license and other revenue and non-cash stock based
compensation expense, for the three and nine months ended September
30, 2011 were $20.9 million and $64.9 million, respectively,
compared to $23.9 million and $72.7 million for the same periods in
2010. Stock based compensation expense was $2.9 million and $9.4
million for the three and nine months ended September 30, 2011,
respectively, compared to $2.2 million and $7.9 million for the
same periods in 2010.
- Research and development expenses for
the three and nine months ended September 30, 2011 were $5.0
million and $17.6 million, respectively, compared to $7.2 million
and $23.1 million for the same periods in 2010.
- Selling, general and administrative
expenses for the three and nine months ended September 30, 2011
were $18.7 million and $56.4 million, respectively, compared to
$18.7 million and $57.2 million for the same periods in 2010.
Net loss for the three months ended September 30, 2011 was $11.2
million, or $0.11 per share, compared to a net loss of $18.8
million, or $0.18 per share, for the same period in 2010. Net loss
for the nine months ended September 30, 2011 was $24.3 million, or
$0.23 per share, compared to $59.3 million, or $0.56 per share for
the same period in 2010.
As of September 30, 2011, the Company had no debt, and $100.4
million in total cash, cash equivalents and investments.
Financial Guidance
Allos is lowering prior operating expense guidance for full year
2011. Prior operating expense guidance for the full year 2011 was
$95 to $98 million. Allos now 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. Stock-based compensation expense
for 2011 is now expected to approximate $12 million, as compared to
prior guidance of $13 to $14 million.
Allos expects that license and other revenue and cost of license
and other revenue, related to the Mundipharma agreement for the
fourth quarter 2011, should approximate $1.0 million and $0.5
million, respectively. This guidance relates to expected research
and development and regulatory services to be performed, which
includes Mundipharma’s current 40% share of jointly agreed-upon
clinical development expenses for FOLOTYN.
As of September 30, 2011, the Company had $100.4 million in
total cash, cash equivalents and investments. The Company expects
this cash position will be sufficient to fund operations through
the end of 2014. This projection is based on historical sales
levels for the first nine months of 2011 and the Company’s
projected operating expenses through 2014. Achievement of growth in
U.S. sales and/or potential milestone payments and royalties
associated with regulatory approval of FOLOTYN in the EU would
further extend the Company’s cash resources.
Actual financial results will vary based upon many factors,
including the amount of FOLOTYN sales and rate of patient
enrollment in ongoing clinical trials of FOLOTYN.
Recent Corporate Events
- On October 21, 2011, the Agreement and
Plan of Merger and Reorganization (“the Merger Agreement”) entered
into by and among Allos, AMAG Pharmaceuticals, Inc. and Alamo
Acquisition Sub, Inc. on July 19, 2011, as amended on August 8,
2011, was terminated following a special meeting of stockholders.
Allos' stockholders voted in favor of the adoption of the Merger
Agreement; AMAG stockholders voted against the proposed merger.
Pursuant to the terms of the Merger Agreement, AMAG paid Allos on
October 25, 2011 a net expense reimbursement amount equal to $1.8
million in connection with such termination.
- In August 2011, Allos enrolled the
first patient in a Phase 3 randomized clinical trial (PDX-017)
evaluating FOLOTYN in patients with first-line peripheral T-cell
lymphoma (PTCL). This study is open to enroll newly diagnosed
patients with PTCL who have achieved an objective response
following initial treatment with CHOP (cyclophosphamide,
doxorubicin, vincristine, and prednisone) or a CHOP-like regimen.
Earlier this year, Allos reached agreement with the U.S. Food and
Drug Administration under its Special Protocol Assessment (SPA)
process on the design of this Phase 3 trial.
Conference Call Information
Allos will host a conference call to review its third quarter
2011 financial results on November 3, 2011, at 8:30 a.m. ET.
Participants can access the call at 1-877-941-2927 (U.S.) or
+480-629-9725 (Canada and international). To access the live audio
webcast or the subsequent archived recording, visit the “Investors
- Presentations and Events” section of the Allos website at
www.allos.com. Webcast and telephone replays of the conference call
will be available approximately two hours after the completion of
the call. Callers can access the replay by dialing 800-406-7325
(domestic) or 303-590-3030 (international). The passcode is
4438057#. The webcast will be recorded and available for replay on
Allos’ website until November 17, 2011.
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 longer with
extensions.
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 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.
ALLOS THERAPEUTICS, INC.
CONDENSED STATEMENTS OF
OPERATIONS
(in thousands, except share and per
share information)
(unaudited)
Three Months Ended
Nine Months Ended September 30, September 30,
2011 2010 2011
2010 Revenue: Net product sales $ 13,215 $
8,230 $ 35,051 $ 23,522
License and other revenue
980 — 29,107 — Total revenue 14,195
8,230 64,158 23,522 Operating costs and expenses: Cost of
sales, excluding amortization expense 1,230 889 3,217 2,330 Cost of
license and other revenue 437 — 11,008 — Research and development
4,996 7,249 17,567 23,056 Selling, general and administrative
18,688 18,702 56,398 57,151 Amortization of intangible asset
113 113 340 340 Total operating costs and
expenses 25,464 26,953 88,530 82,877
Operating loss (11,269) (18,723) (24,372) (59,355) Interest and
other income, net 14 (129) 74 2 Loss
before income taxes (11,255) (18,852) (24,298) (59,353) Income tax
benefit 7 78 7 78 Net loss
($11,248) ($18,774) ($24,291) ($59,275) Net
loss per share: basic and diluted ($0.11) ($0.18)
($0.23) ($0.56) Weighted average shares: basic and
diluted 105,677,687 105,320,554 105,604,438
105,039,263
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
September 30,
December 31, 2011 2010 ASSETS Cash,
cash equivalents and investments $ 100,395 $ 98,565 Accounts
receivable 15,606 12,076 Intangible asset, net 4,885 5,225 Other
assets 3,747 2,645 Property and equipment, net 1,706
2,245 Total assets $ 126,339 $ 120,756
LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities, excluding deferred
revenue $ 21,535 $ 22,558 Deferred revenue 21,342 — Stockholders’
equity 83,462 98,198 Total liabilities and
stockholders’ equity $ 126,339 $ 120,756
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024