Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported its
financial results and business highlights for the quarter and six
months ended June 30, 2010.
Financial Highlights:
- In January 2010, Allos 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).
- Gross product sales were $9.0
million and $17.2 million for the quarter and six months ended June
30, 2010, respectively. Gross product sales in the second quarter
of 2010 increased by 10 percent compared to the first quarter of
2010.
- Net product sales were $7.9
million and $15.3 million for the quarter and six months ended June
30, 2010, respectively, which represents gross product sales less
gross to net sales adjustments.
“During the quarter, we continued to build marketplace awareness
for FOLOTYN for the treatment of relapsed or refractory PTCL,” said
Paul L. Berns, president and chief executive officer of Allos
Therapeutics. “We believe this represents an important market
opportunity for Allos, and we are encouraged by the level of
awareness and use of FOLOTYN at this stage of our commercial
launch. In addition, we continued to drive our strategic lifecycle
development plan for FOLOTYN with the goal of extending its
commercial opportunity and building additional shareholder value
through potential expanded indications in the U.S. and abroad.”
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
second quarter of 2010, sales to distributors were $9.0 million,
which was approximately the same as gross product sales to health
care providers. As such, Allos’ deferred revenue as of June 30,
2010 of $1.2 million remained unchanged from March 31, 2010.
Net product sales were $7.9 million for the second quarter of
2010, which represents the $9.0 million of gross product sales net
of $1.1 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 $20.0 million and $40.5 million, or
$0.19 and $0.39 per share for the quarter and six months ended June
30, 2010, respectively. Total operating costs and expenses for the
second quarter of 2010 were $27.9 million, including stock-based
compensation expense of $2.8 million. Total operating costs and
expenses for the six months ended June 30, 2010 were $55.9 million,
including stock-based compensation expense of $5.7 million.
- Cost of sales for the quarter
and six months ended June 30, 2010 were $0.8 million and $1.4
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 six months ended June 30, 2010 were
$6.5 million and $15.8 million, respectively.
- Selling, general and
administrative expenses for the quarter and six months ended June
30, 2010 were $20.5 million and $38.4 million, respectively.
Net cash used in operating activities for the quarter and six
months ended June 30, 2010 was $16.3 million and $39.6 million,
respectively. As of June 30, 2010, Allos’ cash, cash equivalents
and investments totaled $122.3 million.
Financial Guidance Update
The Company is revising its financial guidance as follows:
- Total operating costs and
expenses for 2010 are expected to approximate $115 to $120 million,
excluding non-cash stock-based compensation expense, a decrease
from prior guidance of $120 to $130 million. Stock-based
compensation expense for 2010 is expected to approximate $12 to $13
million, a decrease from prior guidance of $13 to $15 million.
The Company reaffirms its prior financial guidance as
follows:
- Gross to net sales adjustments
are expected to approximate 12 percent of gross product sales for
the second half of 2010.
- Cost of sales are expected to
approximate 10 percent of net product sales for the second half of
2010, which includes our current 8 percent royalty on FOLOTYN
sales.
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 second half of 2010.
Recent Business Highlights
- Earlier today, the Company
issued a press release announcing topline results from its
randomized Phase 2b investigational trial of FOLOTYN versus
erlotinib in patients with advanced non-small cell lung
cancer.
- In June 2010, new analyses from
the Company’s pivotal PROPEL trial of FOLOTYN in patients with
relapsed or refractory PTCL were presented at the Annual Meeting of
the American Society of Clinical Oncology and European Hematology
Association (EHA).
- In June 2010, updated data from
the Company’s ongoing Phase 1 dose finding study of FOLOTYN in
patients with relapsed or refractory cutaneous T-cell lymphoma
(CTCL) was presented at the EHA meeting.
- In May 2010, the FDA granted
orphan drug designation to FOLOTYN for the treatment of bladder
cancer and in June 2010, the European Commission granted Orphan
Medicinal Product Designation to FOLOTYN for the treatment of
CTCL.
Conference Call Information
Allos will host a conference call to review its second quarter
2010 financial results today, July 28, 2010 at 8:30 a.m. ET.
Participants can access the call at 1-866-225-8754 (U.S. and
Canada) or +480-629-9690 (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
4329512#. The webcast will be recorded and available for replay on
Allos’ website until August 11, 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's 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 June 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 Six Months Ended June
30, June 30, 2010 2009
2010 2009 Net product sales $ 7,885 $ —
$ 15,292 $ — Operating costs and expenses: Cost of sales,
excluding amortization expense 752 — 1,441 — Research and
development 6,522 8,776 15,807 17,137 Selling, general and
administrative 20,517 8,037 38,449 14,999 Amortization of
intangible asset 114 — 227
— Total operating costs and expenses
27,905 16,813 55,924
32,136 Operating loss (20,020 ) (16,813 ) (40,632 ) (32,136
) Interest and other income, net 66 6
131 179 Net loss ($19,954 )
($16,807 ) ($40,501 ) ($31,957 ) Net loss per
share: basic and diluted ($0.19 ) ($0.19 )
($0.39 ) ($0.38 )
Weighted average shares: basic and
diluted
105,187,206 89,011,044
104,896,286 85,075,532
ALLOS THERAPEUTICS,
INC.
CONDENSED BALANCE
SHEETS
(in thousands)
(unaudited)
June 30, December 31, 2010 2009
ASSETS Cash, cash equivalents and investments $ 122,349 $
158,544 Accounts receivable 9,943 4,862 Intangible asset, net 5,452
5,679 Other assets 5,082 4,130 Property and equipment, net
2,500 2,169 Total assets $ 145,326 $ 175,384
LIABILITIES
AND STOCKHOLDERS’ EQUITY Current liabilities, excluding
deferred revenue $ 15,295 $ 15,171 Deferred revenue 1,153 669
Stockholders’ equity 128,878 159,544 Total
liabilities and stockholders’ equity $ 145,326 $ 175,384
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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