Allos Therapeutics, Inc. (NASDAQ: ALTH) today reported financial
results for the fourth quarter and full year ended December 31,
2011.
Financial Highlights:
- $15.4 million in fourth quarter 2011
net product sales, a 17% sequential increase over the third quarter
of 2011.
- $50.5 million in full year 2011 net
product sales, a 43% increase over 2010.
- $97.8 million in total cash, cash
equivalents and investments and no debt as of December 31,
2011.
“We are pleased with the sales growth we achieved in 2011 and
the continued increase in market penetration, disease-state
awareness and brand awareness of FOLOTYN for patients with relapsed
or refractory peripheral T-cell lymphoma,” commented Paul L. Berns,
president and chief executive officer of Allos Therapeutics. “We
enter 2012 with a strong cash position and remain focused on
growing U.S. sales of FOLOTYN while prudently managing our
operating expenses to drive toward future profitability. Also, in
collaboration with Mundipharma, we continue to pursue regulatory
approval for FOLOTYN in the EU and other ex-U.S. geographies as
well as future label expansion opportunities in T-cell
lymphoma.”
The Company’s net product sales for full year 2011 were $50.5
million, compared to $35.2 million for 2010. For the fourth quarter
of 2011, net product sales were $15.4 million, 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.
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 fourth quarter and full year 2011 were $1.5 million and $30.6
million, respectively. As of December 31, 2011, $20.3 million was
recorded as deferred revenue related to the Mundipharma
agreement.
Cost of sales for the fourth quarter and full year 2011 were
$1.3 million and $4.5 million, respectively, compared to $1.3
million and $3.6 million for the same periods in 2010.
Cost of license and other revenue for the fourth quarter and
full year 2011 were $0.7 million and $11.7 million, respectively.
The amount recorded for the full year 2011 was primarily related to
the Company’s payment of $10.0 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 Memorial Sloan-Kettering Cancer Center, SRI
International, and Southern Research Institute.
Research and development (R&D) expenses for the fourth
quarter and full year 2011 were $4.6 million and $22.2 million,
respectively, compared to $8.3 million and $31.4 million for the
same periods in 2010. R&D expenses for full year 2011 include
$3.4 million of non-cash stock-based compensation expense.
Selling, general and administrative (SG&A) expenses for the
fourth quarter and full year 2011 were $11.4 million and $67.8
million, respectively, compared to $21.6 million and $78.8 million
for the same periods in 2010. SG&A expenses for full year 2011
include $8.2 million of non-cash stock-based compensation
expense.
Total operating costs and expenses, excluding cost of sales,
cost of license and other revenue and non-cash stock-based
compensation expense, were $78.9 million for full year 2011, lower
than the Company’s prior guidance of $82 to $84 million.
Net loss for the fourth quarter 2011 was $1.2 million, or $0.01
per share, compared to a net loss of $18.1 million, or $0.17 per
share, for the same period in 2010. Net loss for the full year 2011
was $25.5 million, or $0.24 per share, compared to $77.4 million,
or $0.74 per share, for the same period in 2010.
As of December 31, 2011, the Company had no debt, and cash,
cash equivalents and investments totaling $97.8 million.
Financial Guidance
- FOLOTYN net product sales are expected
to be in the range of $50 to $55 million for 2012, an anticipated
16% to 28% increase over 2011 when excluding certain infrequently
occurring items for 2011 as described above.
- License and other revenue, related to
the Mundipharma agreement, is expected to approximate $9 million
for 2012. Guidance for license and other revenue includes
approximately $4 million of expected payments from Mundipharma to
Allos relating to Mundipharma’s 40% share of jointly agreed-upon
clinical development expenses for FOLOTYN.
- The components of the Company’s
guidance for 2012 total operating costs and expenses are as
follows:
- Cost of sales is expected to be in the
range of $5.0 to $5.5 million for 2012, or 10% of net product
sales.
- Cost of license and other revenue is
expected to approximate $2.5 million for 2012.
- R&D expenses, excluding non-cash
stock-based compensation expense, are expected to approximate $27
million for 2012 as compared to approximately $19 million for 2011.
This increase is primarily due to expected increases in clinical
study costs. Mundipharma’s reimbursements to Allos for 40% of
jointly funded clinical trials are recorded in license and other
revenue as discussed above.
- SG&A expenses, excluding non-cash
stock-based compensation expense, are expected to approximate $48
million for 2012 as compared to approximately $60 million for 2011.
This decrease is primarily due to decreases in personnel costs,
external sales and marketing costs and business development-related
professional fees.
- Amortization of intangible asset is
expected to approximate $0.5 million for 2012.
- Stock-based compensation expense is
expected to approximate $9 million for 2012, of which $2.5 million
and $6.5 million are expected to be recorded in R&D and
SG&A expenses, respectively.
- The Company expects to end 2012 with
approximately $74 to $78 million in total cash, cash equivalents
and investments.
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) annual net product sales and cost of sales for
2012 through 2015 remaining consistent with the Company’s actual
results for fiscal year 2011, and (ii) 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 the Company’s
cash resources assuming operating costs remain consistent with the
Company’s projections.
Non-GAAP financial information is utilized by the Company’s
management to provide a useful measure of the Company’s operating
performance. Non-GAAP financial information herein includes the
financial guidance related to projected operating expenditures for
2012 through 2015. The Company reports the expected reimbursements
from Mundipharma as license and other revenue in accordance with
generally accepted accounting principles but has netted such
reimbursements against its operating expenditures for purposes of
presentation herein.
2011 and Recent Key Highlights
Commercial
- Achieved sequential growth in
year-over-year and quarterly net product sales during 2011;
reported 43% sequential increase in full year 2011 over 2010 and
17% sequential increase in fourth quarter 2011 over third quarter
2011.
- Received a permanent Level II Health
Care Common Procedure Coding System (HCPCS) J-Code for FOLOTYN from
the Centers for Medicare and Medicaid Services (CMS) effective for
dates of service on or after January 1, 2011.
Research and Development
- Submitted a request to the European
Medicines Agency (EMA) for a re-examination of the negative opinion
issued in January 2012 by the EMA’s Committee for Medicinal
Products for Human Use (CHMP) for conditional approval of FOLOTYN
for the treatment of patients with peripheral T-cell lymphoma
(PTCL) whose disease has progressed after at least one prior
systemic therapy. The Company expects a final opinion on the
re-examination to be issued by the CHMP in the second quarter of
2012. Mundipharma has also submitted applications seeking
regulatory approval of FOLOTYN for the treatment of patients with
relapsed or refractory PTCL in Australia, South Korea and
Switzerland and is pursuing regulatory discussions in Japan with
plans for initiation of a bridging study in the second half of
2012.
- Reached agreement with U.S. Food and
Drug Administration under its Special Protocol Assessment (SPA)
process on the design of the Company’s Phase 3 randomized clinical
trial of sequential FOLOTYN in 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 (first-line PTCL). The first
patient was enrolled in this trial in August 2011.
- Announced the publication of the
Company’s pivotal Phase 2 PROPEL study demonstrating clinical
activity of FOLOTYN in patients with relapsed or refractory PTCL in
the Journal of Clinical Oncology.
- Reported interim results from the
Company’s ongoing Phase 1 combination study of FOLOTYN and
bexarotene in patients with relapsed or refractory cutaneous T-cell
lymphoma at the Fourth Annual T-cell Lymphoma Forum. The
combination treatments demonstrated encouraging activity in heavily
pre-treated patients (median of 3 prior systemic regimens). The
cohort determined to be the recommended dose/schedule is being
expanded to evaluate FOLOTYN and bexarotene in a total of 30
patients at the maximum tolerated dose.
Corporate
- Entered into a strategic collaboration
agreement with Mundipharma to co-develop FOLOTYN. Under the
agreement, Allos retains full commercialization rights for FOLOTYN
in the United States and Canada, with Mundipharma having exclusive
rights to commercialize FOLOTYN in the rest of the world. Allos
received an upfront payment of $50 million upon execution of the
agreement and may receive potential regulatory and commercial
progress- and sales-dependent milestone payments of up to $310.5
million. Allos is also entitled to receive tiered double-digit
royalties based on net sales of FOLOTYN within Mundipharma’s
licensed territories. Allos and Mundipharma will jointly fund
development costs, initially on a 60:40 basis, which will change to
a 50:50 basis if certain pre-defined milestones are
achieved.
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 other
countries 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 revenues
through product acquisition and/or in-licensing that leverages the
Company’s existing infrastructure
Conference Call Information
Allos will host a conference call to review its fourth quarter
and full year 2011 financial results on March 6, 2012, at 4:30 p.m.
ET. Participants can access the call at 1-877-941-0843 (U.S.) or
+480-629-9819 (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
4515372#. The webcast will be recorded and available for replay on
Allos’ website until March 20, 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 Memorial Sloan-Kettering Cancer Center, 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, but are not limited to, statements regarding
the status of prospects of the Company’s commercialization of
FOLOTYN for patients with relapsed or refractory peripheral T-cell
lymphoma; the Company’s Marketing Authorization Application, or
MAA, for FOLOTYN in Europe; the Company’s financial guidance for
2012; the Company’s strategic
collaboration with Mundipharma, including Mundipharma’s potential
commercialization of FOLOTYN outside the United States and Canada;
the Company’s future financial performance, results of operations
or sufficiency of capital resources to fund its 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, 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; 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 Year Ended December 31, December
31, 2011 2010 2011
2010 Revenue: Net product sales $ 15,435 $ 11,705 $ 50,486 $
35,227 License and other revenue 1,476 —
30,583 — Total revenue 16,911
11,705 81,069 35,227 Operating costs and expenses: Cost of
sales, excluding amortization expense 1,293 1,317 4,510 3,647 Cost
of license and other revenue 690 — 11,698 — Research and
development 4,622 8,303 22,189 31,359 Selling, general and
administrative 11,419 21,631 67,817 78,782 Amortization of
intangible asset 114 114 454
454 Total operating costs and expenses
18,138 31,365 106,668
114,242 Operating loss (1,227 ) (19,660 ) (25,599 ) (79,015
) Interest and other income, net 11 1,518
85 1,520 Loss before income
taxes (1,216 ) (18,142 ) (25,514 ) (77,495 ) Income tax benefit
— — 7 78
Net loss ($1,216 ) ($18,142 ) ($25,507 )
($77,417 ) Net loss per share: basic and diluted
($0.01 ) ($0.17 ) ($0.24 ) ($0.74 )
Weighted average shares: basic and
diluted
106,029,341 105,373,147
105,711,536 105,123,420
ALLOS
THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in
thousands) (unaudited) December 31,
December 31, 2011 2010 ASSETS
Cash, cash equivalents and investments $ 97,772 $ 98,565 Accounts
receivable 15,259 12,076 Intangible asset, net 4,772 5,225 Other
assets 2,798 2,645 Property and equipment, net 1,476
2,245 Total assets $ 122,077 $ 120,756
LIABILITIES AND
STOCKHOLDERS’ EQUITY Current liabilities, excluding deferred
revenue $ 17,443 $ 22,558 Deferred revenue 20,310 — Stockholders’
equity 84,324 98,198 Total liabilities and
stockholders’ equity $ 122,077 $ 120,756
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Apr 2024 to May 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From May 2023 to May 2024