Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported its
financial results for the quarter and nine months ended September
30, 2010.
Financial Highlights:
- In January 2010, Allos commenced the
commercial launch of FOLOTYN(R) (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).
- Gross product sales were $9.3 million
and $26.5 million for the quarter and nine months ended September
30, 2010, respectively.
- Net product sales were $8.2 million and
$23.5 million for the quarter and nine months ended September 30,
2010, respectively, which represents gross product sales less gross
to net sales adjustments.
“During the quarter, we continued to execute our launch plan to
drive brand awareness in support of the trial, use and adoption of
FOLOTYN in the oncology community,” said Paul L. Berns, president
and chief executive officer of Allos Therapeutics. “We believe this
is an important opportunity for Allos to serve the healthcare
community and, most importantly, patients with relapsed or
refractory PTCL. We also continue to drive our strategic lifecycle
development plan for FOLOTYN in hematologic malignancies and solid
tumors. We recently reported favorable survival data from our
randomized Phase 2b study of FOLOTYN in advanced non-small cell
lung cancer and are in the process of assessing potential Phase 3
development options. In addition, we intend to submit our Marketing
Authorisation Application in Europe for FOLOTYN for the treatment
of relapsed or refractory PTCL by year end.”
Allos sells FOLOTYN to pharmaceutical wholesale distributors who
then resell FOLOTYN to patients' health care providers. Given the
limited sales history for FOLOTYN, Allos currently cannot
reasonably estimate expected returns at the time of shipment to its
distributors. Therefore, in accordance with GAAP, Allos defers
revenue recognition of sales to distributors until the product is
sold through its distributors to health care providers. For the
third quarter of 2010, sales to distributors were $9.7 million. As
of September 30, 2010, Allos has recorded deferred revenue of $1.6
million.
Net product sales were $8.2 million for the third quarter of
2010, which represents the $9.3 million of gross product sales net
of $1.0 million of gross to net sales adjustments. Gross to net
sales adjustments consist of distributor service fees and estimated
accruals for government rebates and chargebacks.
Allos reported a net loss of $18.8 million and $59.3 million, or
$0.18 and $0.56 per share for the quarter and nine months ended
September 30, 2010, respectively. Total operating costs and
expenses for the third quarter of 2010 were $27.0 million,
including non-cash stock-based compensation expense of $2.2
million. Total operating costs and expenses for the nine months
ended September 30, 2010 were $82.9 million, including non-cash
stock-based compensation expense of $7.9 million.
- Cost of sales for the quarter and nine
months ended September 30, 2010 were $0.9 million and $2.3 million,
respectively. Cost of sales consists of an 8 percent royalty under
our license agreement for FOLOTYN and costs for warehousing,
shipping and inventory.
- Research and development expenses for
the quarter and nine months ended September 30, 2010 were $7.2
million and $23.1 million, respectively.
- Selling, general and administrative
expenses for the quarter and nine months ended September 30, 2010
were $18.7 million and $57.2 million, respectively.
Net cash used in operating activities for the quarter and nine
months ended September 30, 2010 was $13.3 million and $52.9
million, respectively. As of September 30, 2010, Allos' cash, cash
equivalents and investments totaled $108.9 million. In October
2010, we received notice that we were approved to receive
approximately $1.5 million under the Therapeutic Discovery Tax
Credit, which is not reflected in our cash balance as of September
30, 2010. This cash payment to Allos will be recorded in Other
Income in the fourth quarter.
Financial Guidance Update
The Company is revising its financial guidance as follows:
- Total operating costs and expenses for
2010 are expected to approximate $105 to $110 million, excluding
non-cash stock-based compensation expense, a decrease from prior
guidance of $115 to $120 million. Stock-based compensation expense
for 2010 is expected to approximate $12 million.
Actual financial results for 2010 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 the fourth quarter of 2010.
Conference Call Information
Allos will host a conference call to review its third quarter
2010 financial results today, November 4, 2010 at 4:30 p.m. ET.
Participants can access the call at 1-877-941-2928 (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 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
4375395#. The webcast will be recorded and available for replay on
Allos’ website until November 18, 2010.
About Peripheral T-Cell Lymphoma (PTCL)
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) in the United States.1-3 The American
Cancer Society estimated that approximately 66,000 new cases of NHL
were expected to be diagnosed in the U.S. in 2010. The Company
estimates the current annual incidence of PTCL in the U.S. to be
approximately 5,900 patients. 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 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.
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.
Dermatologic reactions may occur. Patients with dermatologic
reactions should be monitored closely.
Adverse Reactions:
The most common adverse reactions observed were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events were 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/sulfamethaxazole) may result
in delayed renal clearance.
A copy of the full prescribing information for FOLOTYN,
including warnings, precautions, adverse events and other safety
information may be obtained in the U.S. from Allos Therapeutics by
calling toll-free 888-255-6788 or by visiting the web site at
www.allos.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. These forward-looking
statements include, but are not limited to, statements regarding
the commercialization of FOLOTYN for the treatment of patients with
relapsed or refractory PTCL; Allos’ projected operating costs and
expenses for fiscal year 2010; 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; Allos’ dependence on third party manufacturers;
Allos’ compliance with applicable regulatory requirements,
including the healthcare fraud and abuse laws and Allos’
post-marketing requirements; and that Allos may lack the financial
resources and access to capital to support its future operations,
including its product development and commercialization plans for
FOLOTYN. 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, 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 Allos on the date hereof, and Allos
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.
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 trademarks of Allos
Therapeutics, Inc.
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, 2010
2009 2010 2009 Net product sales $8,230
$ — $23,522 $ — Operating costs and expenses: Cost of sales,
excluding amortization expense 889 — 2,330 — Research and
development 7,249 7,538 23,056 24,675 Selling, general and
administrative 18,702 11,327 57,151 26,326 Amortization of
intangible asset 113 7 340 7 Total operating costs and expenses
26,953 18,872 82,877 51,008 Operating loss (18,723) (18,872)
(59,355) (51,008) Interest and other income, net (129)
125
2 304 Loss before income taxes (18,852) (18,747) (59,353) (50,704)
Income tax benefit 78 77 78 77 Net loss ($18,774) ($18,670)
($59,275) ($50,627) Net loss per share: basic and diluted ($0.18)
($0.21) ($0.56) ($0.58)
Weighted average shares: basic and
diluted
105,320,554 89,543,949 105,039,263 86,581,372
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
September 30, December 31, 2010
2009 ASSETS Cash, cash equivalents and investments $
108,920 $ 158,544 Accounts receivable 9,633 4,862 Intangible asset,
net 5,339 5,679 Other assets 4,344 4,130 Property and equipment,
net 2,237 2,169 Total assets $ 130,473 $ 175,384
LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities, excluding deferred
revenue $ 16,555 $ 15,171 Deferred revenue 1,587 669 Stockholders’
equity 112,331 159,544 Total liabilities and stockholders’ equity $
130,473 $ 175,384
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