Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported financial
results for the fourth quarter and full year ended December 31,
2010.
Financial Highlights:
- In January 2010, the Company commenced
the commercial launch of FOLOTYN® (pralatrexate injection) – the
first and only drug approved in the U.S. for the treatment of
patients with relapsed or refractory peripheral T-cell lymphoma
(PTCL).
- $11.8 million in gross product sales to
health care providers for the fourth quarter 2010, a 27 percent
sequential increase over third quarter 2010.
- $11.7 million and $35.2 million in net
product sales for the fourth quarter and full year 2010,
respectively.
- $98.6 million in total cash and
investments and no debt as of December 31, 2010.
“We made important progress during 2010, including the launch of
FOLOTYN in the United States and the build-out of our commercial
infrastructure,” said Paul L. Berns, president and chief executive
officer of Allos Therapeutics. “We are encouraged by the initial
trial, use and adoption of FOLOTYN in the first full year of
commercialization. We believe the market opportunity for relapsed
or refractory PTCL is substantial, and our goal is to establish
FOLOTYN as the standard of care for this patient population. Our
key objectives in 2011 include driving U.S. sales of FOLOTYN for
relapsed or refractory PTCL, advancing studies of FOLOTYN in other
hematologic malignancies and expanding the commercial potential of
FOLOTYN outside the U.S. through a potential strategic partnership
and pursuing regulatory approval in the EU.”
Allos sells FOLOTYN to pharmaceutical wholesale distributors who
then resell FOLOTYN to patients' health care providers. As
previously reported, the Company’s fourth quarter 2010 sales,
including a comparison to the third quarter 2010, are summarized as
follows:
$ in millions
Q32010
Q42010
%Increase
Gross product sales to distributors
(factory sales)
$
9.7
$
12.1
25
%
Gross product sales to health care providers (demand sales) $ 9.3 $
11.8 27 % Net product sales, excluding $1.1M Q4 one-time increase $
8.2 $ 10.6 29 % Net product sales, including $1.1M Q4 one-time
increase $ 8.2 $ 11.7 42 %
A reconciliation of gross to net product sales for the fourth
quarter 2010 is as follows:
$ in millions
Q4 2010 Gross factory sales $ 12.1 Gross
to net sales adjustments of 12%
($ 1.5
) Net product sales, excluding one-time increase $
10.6
One-time increase
$ 1.1 Net product sales, including
one-time increase
$ 11.7
Prior to the fourth quarter 2010, the Company recognized revenue
on the basis of demand sales. During the fourth quarter 2010, the
Company began recognizing revenue on the basis of factory sales, as
the Company established a sufficient history in order to reasonably
estimate returns in accordance with GAAP. The $1.1 million one-time
increase in fourth quarter 2010 net product sales represents the
cumulative difference between factory sales and demand sales at the
end of the third quarter 2010 less applicable gross to net sales
adjustments.
Net product sales for the fourth quarter and full year 2010 were
$11.7 million and $35.2 million, respectively, which include
one-time increases of $1.1 million and $0.6 million, respectively,
resulting from the change in the Company’s revenue recognition
methodology.
Net loss for the fourth quarter and full year 2010 were $18.1
million and $77.4 million, or $0.17 and $0.74 per share,
respectively.
Total operating costs and expenses, excluding non-cash stock
based compensation expense, for the fourth quarter and full year
2010 were $27.8 million and $102.8 million, respectively, which was
lower than the Company’s full year 2010 guidance of $105 to $110
million. Stock based compensation expense for the fourth quarter
and full year 2010 was $3.5 million and $11.4 million,
respectively.
- Cost of sales for the fourth quarter
and full year 2010 was $1.3 million and $3.6 million,
respectively.
- Research and development expenses for
the fourth quarter and full year 2010 were $8.3 million and $31.4
million, respectively.
- Selling, general and administrative
expenses for the fourth quarter and full year 2010 were $21.6
million and $78.8 million, respectively.
Interest and other income for the fourth quarter and full year
2010 of $1.5 million includes a cash payment of approximately $1.5
million received by the Company under the Therapeutic Discovery Tax
Credit.
As of December 31, 2010, the Company had no debt, and cash,
cash equivalents and investments totaling $98.6 million.
Financial Guidance for 2011
Total operating costs and expenses, excluding cost of sales and
non-cash stock-based compensation expense, are expected to
approximate $95 to $98 million for 2011. Stock-based compensation
expense is expected to approximate $13 to $15 million for 2011.
Gross to net sales adjustments are expected to approximate 12
percent of factory sales for 2011. Cost of sales is expected to
approximate 10 percent of factory sales for 2011, which includes
the current 8 percent royalty on FOLOTYN sales. Actual financial
results for 2011 will vary based upon many factors, including the
amount of FOLOTYN sales and rate of patient enrollment in FOLOTYN
clinical trials that are ongoing and planned for initiation in
2011.
2011 Key Business Priorities
- Drive growth in U.S. sales of FOLOTYN
for relapsed or refractory PTCL
- Pursue regulatory approval to market
FOLOTYN in the European Union for relapsed or refractory PTCL
- The Company’s Marketing Authorisation
Application (MAA) was accepted for review by the European Medicines
Agency (EMA) in December 2010
- Secure strategic partner for the
co-development of FOLOTYN globally and commercialization outside
the United States
- Advance FOLOTYN development program in
hematologic malignancies and pursue new indications
- Obtain FDA agreement and initiate Phase
3 trial of sequential FOLOTYN in previously untreated patients with
PTCL following CHOP or a CHOP-like chemotherapy regimen
- The Company announced today that it has
reached agreement on this trial with the U.S. Food and Drug
Administration (FDA) under its Special Protocol Assessment (SPA)
process
- Determine maximum tolerated dose and
obtain FDA agreement for Phase 3 trial of FOLOTYN in combination
with systemic bexarotene in patients with relapsed or refractory
cutaneous T-cell lymphoma (CTCL)
- Explore FOLOTYN’s utility in solid
tumors through targeted investments
- Ongoing collaboration with the National
Comprehensive Cancer Network (NCCN) Oncology Research Program
- Complete ongoing Company-sponsored
studies in bladder and breast cancer
2010 and Recent Highlights
U.S. Commercial:
- Commenced commercial launch of FOLOTYN
for patients with relapsed or refractory PTCL in January 2010.
- Achieved sequential growth in quarterly
sales during 2010; reported 27 percent sequential increase in
fourth quarter demand sales over third quarter 2010.
Research and Development:
- Received notice that the NCCN updated
the non-Hodgkin lymphoma Clinical Practice Guidelines and the Drug
and Biologics Compendium to include FOLOTYN for the treatment of
CTCL patients with mycosis fungoides and Sézary syndrome. NCCN is
recognized by the Centers for Medicare and Medicaid Services and
private payers as a mandated reference for oncology coverage
policies.
- Announced the Company’s MAA was
accepted for review by the EMA in December 2010.
- Reported updated results from pivotal
PROPEL study of FOLOTYN in patients with relapsed or refractory
PTCL at the 52nd Annual Meeting of the American Society of
Hematology (ASH).
- Reported updated results from ongoing
dose finding investigational Phase 1 study that demonstrated
activity of FOLOTYN in patients with CTCL at ASH.
- Reported top-line results in July and
additional data at the European Society of Medical Oncology in
October 2010 demonstrating the clinical activity of FOLOTYN in a
randomized study relative to erlotinib, an approved active agent in
non-small cell lung cancer (NSCLC). The Company announced in
January 2011 that it will not pursue Phase 3 studies for NSCLC at
this time.
- Reached agreement with FDA under its
SPA process on the design of the Company’s Phase 3 trial of
sequential FOLOTYN in previously untreated patients with PTCL
following CHOP or a CHOP-like chemotherapy regimen.
Corporate:
- Received approximately $1.5 million
under the Therapeutic Discovery Tax Credit in the fourth quarter
2010.
Conference Call Information
Allos will host a conference call to review its fourth quarter
and full year 2010 financial results today, March 3, 2011 at 4:30
p.m. ET. Participants can access the call at 1-800-762-8779 (U.S.)
or +480-629-9771 (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
4410612#. The webcast will be recorded and available for replay on
Allos’ website until March 17, 2011.
About Peripheral T-Cell Lymphoma
T-cell lymphomas comprise a biologically diverse group of blood
cancers that account for approximately 10% to 15% of all cases of
non-Hodgkin lymphoma (NHL).1-3 The Company 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 relapsed or 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 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.
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 the
first and only drug approved in the U.S. for the treatment of
patients with relapsed or refractory peripheral T-cell lymphoma.
Allos is also developing FOLOTYN in other hematologic malignancies
and solid tumors. Allos retains exclusive worldwide rights to
FOLOTYN for all indications. Allos is headquartered in Westminster,
CO. 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 ≥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 ≥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 commercialization of
FOLOTYN for the treatment of patients with relapsed or refractory
PTCL; the Company’s projected operating costs and expenses for
fiscal year 2011; the Company’s intent to enter into a strategic
partnership for the continued development and potential future
commercialization of FOLOTYN outside the United States; and other
statements that are other than statements of historical facts. 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, the
risks and uncertainties associated with the commercialization of
FOLOTYN; the ability to expand the approved indications for
FOLOTYN; the status of reimbursement from third party payers; the
Company’s dependence on third party manufacturers; the Company’s
compliance with applicable regulatory requirements, including the
healthcare fraud and abuse laws and the Company’s post-marketing
requirements; that the design of and data collected from the 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; that the
Company may lack the financial resources and access to capital to
support its future operations, including its product development
and commercialization plans for FOLOTYN and that the Company may be
unable to negotiate a strategic partnership for the continued
development and potential future commercialization of FOLOTYN
outside the United States on acceptable terms, or at all.
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 Annual Report on Form 10-K for the year
ended December 31, 2010, 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.
Note: The Allos logo and FOLOTYN name are registered trademarks
of Allos Therapeutics, Inc.
ALLOS THERAPEUTICS, INC.
CONDENSED STATEMENTS OF
OPERATIONS
(in thousands, except share and per
share information)
(unaudited)
Three Months Ended Year Ended
December 31, December 31, 2010
2009 2010 2009 Net product sales $
11,705 $ 3,585 $ 35,227 $ 3,585 Operating costs and
expenses: Cost of sales, excluding amortization expense 1,317 408
3,647 408 Research and development 8,303 7,944 31,359 32,618
Selling, general and administrative 21,631 18,121 78,782 44,448
Amortization of intangible asset 114 114
454 121 Total operating costs
and expenses 31,365 26,587
114,242 77,595 Operating loss (19,660 )
(23,002 ) (79,015 ) (74,010 ) Interest and other income, net
1,518 76 1,520 380
Loss before income taxes (18,142 ) (22,926 ) (77,495 ) (73,630 )
Income tax benefit — — 78
77 Net loss ($18,142 ) ($22,926 )
($77,417 ) ($73,553 ) Net loss per share: basic and
diluted ($0.17 ) ($0.22 ) ($0.74 )
($0.81 )
Weighted average shares: basic and
diluted
105,373,147 102,007,968
105,123,420 90,469,720
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, December 31, 2010
2009 ASSETS Cash, cash equivalents and investments $
98,565 $ 158,544 Accounts receivable 12,076 4,862 Intangible asset,
net 5,225 5,679 Other assets 2,645 4,130 Property and equipment,
net 2,245 2,169 Total assets $ 120,756 $ 175,384
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities,
excluding deferred revenue $ 22,558 $ 15,171 Deferred revenue — 669
Stockholders’ equity 98,198 159,544 Total liabilities
and stockholders’ equity $ 120,756 $ 175,384
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