Alexza Reports 2012 Fourth Quarter and Full Year Financial Results
Management to Review Results and Provide Business Updates in Conference Call
Scheduled Today for 5:00 p.m. Eastern Time
MOUNTAIN VIEW, Calif., March 26, 2013
MOUNTAIN VIEW, Calif., March 26, 2013 /PRNewswire/ --Alexza Pharmaceuticals,
Inc. (Nasdaq: ALXA) today reported financial results for the fiscal quarter
and full year ended December 31, 2012. The net loss for the quarters ended
December 31, 2012 and 2011, as reported in accordance with accounting
principles generally accepted in the United States (GAAP), were $10.3 million
and $9.7 million, respectively. The net loss for the year ended December 31,
2012 was $28.0 million compared to $40.5 million for the same period in 2011.
At December 31, 2012, Alexza had consolidated cash, cash equivalents,
marketable securities and restricted cash of $22.8 million.
"This year will be a transformational year for Alexza, following the receipt
of regulatory approvals in the U.S. and Europe for ADASUVE^®, ^ our first
approved Staccato^®-based product," said Thomas B. King, President and CEO of
Alexza. "We are actively planning for the ADASUVE launch in the third quarter
and are putting in place what we believe to be the necessary elements,
including the U.S. commercial strategy, intended to support the successful
commercialization of this product."
Alexza Business Updates
oIn December 2012, the Committee for Medicinal Products for Human Use of
the European Medicines Agency adopted a positive opinion recommending that
ADASUVE (Staccato loxapine) 4.5 mg and 9.1 mg inhalation powder,
pre-dispensed, be granted European Union centralized marketing
oIn December 2012, the U.S. Food and Drug Administration approved ADASUVE
(loxapine) Inhalation Powder 10 mg for the acute treatment of agitation
associated with schizophrenia or bipolar I disorder in adults.
oIn December 2012, Alexza and its Staccato system were presented the Frost
& Sullivan 2012 Global Enabling Technology Award, based on Frost &
Sullivan's analysis of the bipolar disorder therapeutics market.
oIn January 2013, J. Kevin Buchi was appointed to the Alexza Board of
Directors. Mr. Buchi has more than 30 years of pharmaceutical industry
experience, most recently as Corporate Vice President, Global Branded
Products at Teva Pharmaceutical Industries and previously served as Chief
Executive Officer, Chief Operating Officer and Chief Financial Officer,
successively, during his tenure at Cephalon, Inc.
oIn February 2013, the European Commission granted marketing authorization
for ADASUVE (Staccato loxapine), 4.5 mg and 9.1 mg inhalation powder,
pre-dispensed, for the rapid control of mild-to-moderate agitation in
adult patients with schizophrenia or bipolar disorder.
oIn March 2013, Peter W. Schineller joined the Company as Senior Vice
President and Chief Commercial Officer. Mr. Schineller brings more than
twenty years of industry experience directing sales and marketing efforts
at multinational pharmaceutical and specialty pharmaceutical companies for
numerous diagnostic and therapeutic products. In this newly created role,
Mr. Schineller will be responsible for overseeing Alexza's global
commercialization efforts and strategies for ADASUVE.
oIn March 2013, Alexza commenced the commercial manufacturing of ADASUVE in
its facilities in Mountain View, CA. Product manufactured at this
facility will supply the U.S. and EU markets.
Financial Results - Periods Ended December 31, 2012 and 2011
Alexza recorded $0.7 million and $4.1 million of revenues in the quarter and
year ended December 31, 2012, respectively, compared to $1.9 million and $5.7
million in the same periods of 2011. In 2012, Alexza recognized a full year
of revenue earned under the Grupo Ferrer license agreement and one quarter of
a year's revenue from the license agreement with Cypress Biosciences, Inc. In
2011, Alexza recognized a full year of revenue under the Cypress license
agreement and one quarter of revenue under the Grupo Ferrer license agreement.
GAAP operating expenses were $11.6 million in the quarter ended December 31,
2012 compared to $10.4 million during the fourth quarter of 2011. Full-year
2012 operating expenses were $32.9 compared to $40.0 million in the same
period in 2011.
Research and development expenses were $7.0 million and $21.8 million in the
quarter and year ended December 31, 2012, as compared to $7.3 million and
$28.3 million in the same periods in 2011, respectively. The decreased
expenses in 2012 were a result of the suspension of development of AZ-007 and
Staccato nicotine product candidates starting in late 2011, as well as efforts
to conserve cash resources, including a 38% reduction in workforce in February
2012. These reductions were partially offset by approximately $1.1 million
and $0.9 million of cash bonuses and share-based compensation expense incurred
in the fourth quarter of 2012 that were not incurred in 2011, the result of
achieving certain specific corporate goals related to the ADASUVE marketing
approvals, as specified in the Company's bonus plans.
General and administrative expenses were $4.6 million and $11.1 million in the
quarter and year ended December 31, 2012, respectively, compared to $3.1
million and $11.8 million for the same periods in 2011. General and
administrative expenses in 2012 were impacted by a reduction in non-cash
expenses of $1.4 million as a result of the termination of one of the
Company's building leases and related subleases in March 2012. Alexza
incurred approximately $0.9 million and $1.0 million of cash bonuses and
share-based compensation expense in the fourth quarter of 2012 that were not
incurred in 2011, the result of meeting certain corporate goals related to the
ADASUVE marketing approvals, as specified in the Company's bonus plans.
In connection with the acquisition of Symphony Allegro, Inc. in August 2009,
Alexza is obligated to pay the former Symphony Allegro stockholders certain
percentages of cash payments that may be generated from collaboration
transactions for ADASUVE, AZ-002 (Staccato alprazolam) or AZ-104 (Staccato
loxapine, low-dose). The Company records this obligation as a contingent
liability and updates the liability each quarter. Alexza recorded a
non-operating gain of $0.9 million and $1.9 million during the quarter and
year ended December 31, 2012, respectively, compared to a non-operating loss
of $0.7 million and $4.0 million in the same periods in 2011. Gains and
losses incurred reflect Alexza's change in the estimated probability-weighted
cash flows from ADASUVE, AZ-002 and AZ-104 and the estimated timing of receipt
of such cash flows.
Alexza believes that based on its cash, cash equivalents, marketable
securities and restricted cash balance at December 31, 2012 and the Company's
expected cash usage, the Company has sufficient capital resources to meet its
anticipated cash needs, at its current cost levels, into the second quarter of
Conference Call Information - 5:00 p.m. Eastern Time on March 26, 2013
To access the conference call via the Internet, go to www.alexza.com, under
the "Investor Relations" link. Please join the call at least 15 minutes prior
to the start of the call to ensure time for any software downloads that may be
required. Interested parties may also pre-register to avoid pre-call delays
at https://www.theconferencingservice.com/prereg/key.process?key= PV9FTPNLQ.
To access the live conference call via telephone, dial 888-679-8035.
International callers may access the live call by dialing +1-617-213-4848.
The reference number to enter the call is 99281086.
The replay of the conference call may be accessed via the Internet, at
www.alexza.com, or via telephone at 888-286-8010 for domestic callers or
+1-617-801-6888 for international callers. The reference number for the
replay of the call is 44796025. A replay of the call will be available for
two weeks following the event.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development and
commercialization of novel, proprietary products for the acute treatment of
central nervous system conditions, including agitation, acute repetitive
seizures and insomnia. Alexza's products are based on the Staccato^® system,
a hand-held inhaler that is designed to deliver a drug aerosol to the deep
lung, providing rapid systemic delivery and therapeutic onset, in a simple,
ADASUVE^® (Staccato loxapine) is Alexza's first approved product, which was
approved by the U.S. Food and Drug Administration in December 2012 and by the
European Medicines Agency in February 2013. Grupo Ferrer Internacional, S.A.
is Alexza's commercial partner for ADASUVE in Europe, Latin America, Russia
and the Commonwealth of Independent States countries. The commercial launch
of ADASUVE is planned for the third quarter 2013 in the U.S. and Europe.
For more information about Alexza, the Staccato system technology or the
Company's development programs, please visit www.alexza.com. For more
information about ADASUVE, please visit www.adasuve.com.
ADASUVE^® and Staccato^® are registered trademarks of Alexza Pharmaceuticals,
ADASUVE Partial Prescribing Information (U.S.)
Please click here for Full Prescribing Information, including Boxed WARNINGS.
INDICATIONS AND USAGE
ADASUVE is a typical antipsychotic indicated for the acute treatment of
agitation associated with schizophrenia or bipolar I disorder in adults.
Efficacy was demonstrated in 2 trials in acute agitation: one in schizophrenia
and one in bipolar I disorder.
Limitations of Use: ADASUVE must be administered only in an enrolled
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH
oADASUVE can cause bronchospasm that has the potential to lead to
respiratory distress and respiratory arrest
oADASUVE is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS
oAdminister ADASUVE only in an enrolled healthcare facility that has
immediate access on-site to equipment and personnel trained to manage
acute bronchospasm, including advanced airway management (intubation and
Increased Mortality in Elderly Patients with Dementia-Related Psychosis:
oElderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death. ADASUVE is not
approved for the treatment of patients with dementia-related psychosis
ADASUVE is contraindicated in patients with the following:
oCurrent diagnosis or history of asthma, chronic obstructive pulmonary
disease (COPD), or other lung disease associated with bronchospasm
oAcute respiratory signs / symptoms (e.g., wheezing)
oCurrent use of medications to treat airways disease, such as asthma or
oHistory of bronchospasm following ADASUVE treatment
oKnown hypersensitivity to loxapine and amoxapine
WARNINGS AND PRECAUTIONS:
oNeuroleptic Malignant Syndrome: May develop in patients treated with
antipsychotic drugs. Discontinue treatment
oHypotension and Syncope: Use with caution in patients with known
cardiovascular or cerebrovascular disease
oSeizure: Use with caution in patients with a history of seizures or with
conditions that lower the seizure threshold
oPotential for Cognitive and Motor Impairment: Use caution when driving or
oCerebrovascular Adverse Reactions: Increased incidence of stroke and
transient ischemic attack in elderly patients with dementia-related
psychosis treated with antipsychotic drugs
The most common adverse reactions (incidence ≥ 2% and greater than placebo) in
clinical studies in patients with agitation treated with ADASUVE were
dysgeusia, sedation, throat irritation.
Safe Harbor Statement
Alexza's policy is to only provide guidance on product candidates and
corporate goals for the future one to two fiscal quarters, and to provide,
update or reconfirm its guidance only by issuing a press release or filing
updated guidance with the SEC in a publicly accessible document. Clinical and
corporate milestones guidance is as of March 26, 2013 and financial guidance
relating to the Company's current cash, cash equivalents, investments and
restricted cash is based upon balances as of December 31, 2012 and certain
This news release and the planned conference call will contain forward-looking
statements that involve significant risks and uncertainties. Any statement
describing the Company's expectations or beliefs is a forward-looking
statement, as defined in the Private Securities Litigation Reform Act of 1995,
and should be considered an at-risk statement. Such statements are subject to
certain risks and uncertainties, particularly those inherent in the process of
developing and commercializing drugs, including the ability for Alexza and
Ferrer to effectively and profitably commercialize ADASUVE, the adequacy of
the Company's capital to support the Company's operations, and the Company's
ability to raise additional funds and the potential terms of such potential
financings. The Company's forward-looking statements also involve assumptions
that, if they prove incorrect, would cause its results to differ materially
from those expressed or implied by such forward-looking statements. These and
other risks concerning Alexza's business are described in additional detail in
the Company's Annual Report on Form 10-K for the year ended December 31, 2012
and the Company's other Periodic and Current Reports filed with the Securities
and Exchange Commission. Forward-looking statements contained in this
announcement are made as of this date, and the Company undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events or otherwise.
ALEXZA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Quarter Ended Year Ended
December 31, December 31,
2012 2011 2012 2011
Revenue $ 729 $ $ 4,070 $ 5,660
Research and development 7,023 7,285 21,849 28,262
General and administrative 4,606 3,102 11,093 11,766
Total operating expenses 11,629 10,387 32,942 40,028
Loss from operations (10,900) (8,503) (28,872) (34,368)
Gain (loss) on change in
fair value of contingent 900 (700) 1,900 (4,000)
Interest and other income/ 7 (4) 420 26
Interest expense (280) (486) (1,426) (2,189)
Net loss $(10,273) $ (9,693) $(27,978) $ (40,531)
Basic and diluted net loss $ (0.65) $ (1.34) $ (2.24) $ (5.97)
ALEXZA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, December 31,
Cash, cash equivalents and marketable $ 17,715 $ 16,903
Restricted cash 5,051 -
Other current assets 852 10,649
Total current assets 23,618 27,552
Property and equipment, net 16,531 20,425
Other noncurrent assets 402 628
Total assets $ 40,551 $ 48,605
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
Total current liabilities $ 18,718 $ 34,948
Noncurrent liabilities 19,260 23,349
Total stockholders' (deficit) equity 2,573 (9,692)
Total liabilities and stockholders' $ 40,551 $ 48,605
(1) Derived from audited consolidated financial statements at that date.
SOURCE Alexza Pharmaceuticals, Inc.
Contact: BCC Partners, Karen L. Bergman and Michelle Corral, 650.575.1509 or
415.794.8662, email@example.com or firstname.lastname@example.org
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