MOUNTAIN VIEW, Calif.,
Nov. 6, 2013 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported
financial results for the quarter ended September 30, 2013. The net loss for the
third quarter was $12.4 million
compared to $6.9 million during the
same quarter in 2012. The net loss for the nine months ended
September 30, 2013 and 2012, was
$33.9 million and $17.7 million, respectively. At
September 30, 2013, Alexza had
consolidated cash, cash equivalents and marketable securities of
$32.5 million.
"In the third quarter we achieved a major milestone with the
first commercial sales of ADASUVE, as Grupo
Ferrer launched the product in Germany. We are excited
by Ferrer's progress in rolling out ADASUVE in Europe, with additional countries expected to
launch through 2014," said Thomas B.
King, President and CEO of Alexza. "In the U.S., our
partner Teva is ramping up their pre-launch activities and we
continue to be impressed by their commitment and
professionalism. With regard to Alexza's product development
pipeline, we are planning to initiate the Phase 2 study of AZ-002
(Staccato alprazolam) for acute repetitive seizures in the
first quarter of 2014."
Alexza Business Updates
- In July 2013, Alexza's commercial
partner Grupo Ferrer Internacional,
S.A. initiated sales of ADASUVE® inhalation powder,
pre-dispensed (Staccato® Loxapine) in Germany.
Ferrer's first sale and product shipment triggered a $1.25 million milestone payment to Alexza.
- In July 2013, Kelly Seither was promoted to Vice President,
Global Strategic Marketing and New Product Planning and Tatjana
Naranda, PhD, was promoted to Vice President, Business Development
and Global Alliance Management.
- In September 2013, Ferrer
completed an ADASUVE commercialization agreement with Medivir AB,
headquartered in Stockholm, for
the Nordic region (Denmark,
Finland, Norway, Iceland and Sweden).
- In October 2013, Ferrer initiated
sales of ADASUVE in Austria. Ferrer is commercializing
ADASUVE in Austria through a
distribution agreement with AOP Orphan Pharmaceuticals AG.
AOP Orphan, headquartered in Vienna, is Ferrer's marketing partner for
ADASUVE in Central and Eastern
Europe (Austria,
Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Switzerland, Slovakia and Slovenia)
Financial Results - Periods Ended September 30, 2013 and 2012
Alexza recorded revenues of $2.2
million and $46.5 million in
the three and nine months ended September
30, 2013, respectively, compared to $0.7 million and $3.3
million in the same periods in 2012, respectively. The
revenues in 2013 consist of $42.8
million of licensing revenues from Teva, amortization of the
upfront payment from the Ferrer agreement and transfer pricing of
units shipped to Ferrer. Revenues in 2012 represent the
amortization of upfront payments earned under Alexza's agreements
with Ferrer and Cypress Bioscience.
GAAP operating expenses were $12.5
million and $35.4 million in
the three and nine months ended September
30, 2013, respectively, and $7.1
million and $21.3 million in
the same periods in 2012, respectively.
Cost of goods sold were $4.0
million and $6.9 million
during the three and nine months ended September 30, 2013. Cost of goods sold
primarily consists of start-up activities related to commercial
manufacturing operations, and, to a lesser extent, manufacture of
commercial product. Alexza is in the early stages of
commercialization and has incurred significantly higher than normal
indirect costs in the production of its inventory. These
costs are associated with manufacturing start-up costs and low
production volumes, and Alexza expects to continue to incur higher
than normal indirect costs until it gets closer to its normal
manufacturing capacity. Note that all costs associated with
the manufacturing process incurred prior to the first commercial
product produced in the second quarter of 2013were expensed as a
component of research and development expense.
Research and development expenses were $5.5 million in the third quarter and
$16.5 million in the nine months
ended September 30, 2013, compared to
$4.8 million and $14.8 million in the same periods in 2012,
respectively. The increase was primarily a result of
additional regulatory expenses and costs associated with Alexza's
post-approval commitments related to the Marketing Authorization
Application approval, partially offset by expenses related to
quality and manufacturing being classified as cost of goods sold in
2013.
General and administrative expenses were $3.1 million in the third quarter and
$12.0 million in the nine months
ended September 30, 2013, as compared
to $2.3 million and $6.5 million in the same periods in 2012,
respectively. The increase was partially due to
pre-commercialization efforts such as market research, including
pricing and market segmentation studies, and increased headcount
and external expenses to support increased operational activities
following the approval of the ADASUVE New Drug Application (NDA) in
December 2012 by the U.S. Food and
Drug Administration (FDA). As part of the license and supply
agreement signed in May 2013, Teva
assumed these efforts. In 2012, general and administrative
expenses were reduced by $1.4
million, as a result of the termination of one of the
Company's building leases and related subleases in March 2012.
In connection with the acquisition of Symphony Allegro 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. For the third quarter 2013, the loss on the
change in the fair value of the contingent liability was due to the
passage of three months on the discounted cash flow model resulting
in a non-operating loss of $1.6
million. In the nine months ended September 30, 2013, Alexza updated the contingent
liability fair value model to reflect the increase in probability
that Alexza would license the commercialization rights of ADASUVE
in the US to a third party rather than commercialize on its own,
and to reflect the terms of the Teva Agreement and reduced the
discount factor used in the model, resulting in Alexza recording
non-operating loss of $44.0 million.
During 2013, Alexza made payments of $10 million and a $0.3
million to the former Symphony Allegro stockholders as a
result of the $40 million upfront
payment received from Teva and the $1.25
million payment received from Ferrer for the first
commercial sale made in Germany.
In the third quarter of 2013, the Company drew down $10 million against the Teva Note and
reclassified $901,000 of the
unamortized right-to-borrow as a cost of borrowing to be amortized
to interest expense over the life of the borrowing. The
Company recorded $348,000 and
$555,000 in interest expense related
to the right-to-borrow in the three and nine months ended
September 30, 2013, respectively.
Alexza believes that based on its cash, cash equivalents and
marketable securities balance at September
30, 2013, estimated product revenues, royalties and
milestones associated with the sale of ADASUVE, remaining proceeds
available under the Teva Note, and expected cash usage, it has
sufficient capital resources to meet its anticipated cash needs
into the third quarter of 2014.
Conference Call Information - 5:00 p.m.
Eastern Time on November 6,
2013
Investors and analysts may access the live conference call by
dialing 888-680-0879 (domestic) or +1-617-213-4856
(international). The reference number to enter the call is
95388115. Interested parties may also pre-register for the
call at:
https://www.theconferencingservice.com/prereg/key.process?key=PK46KVA67.
To access the webcast 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.
A replay of the conference call may be accessed at
www.alexza.com under the "Investor Relations" link, or by dialing
888-286-8010 or +1-617-801-6888 (international). The
reference number for the replay of the call is 37910049. A
replay of the call will be available for 30 days 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. Alexza's
products are based on the Staccato system, a hand-held
inhaler designed to deliver a drug aerosol to the deep lung,
providing rapid systemic delivery and therapeutic onset, in a
simple, non-invasive manner.
ADASUVE (Staccato loxapine) is Alexza's first commercial
product, which was approved by the U.S. Food and Drug
Administration in December 2012 and
by the European Commission in February 2013. Teva
Pharmaceuticals USA, Inc. is
Alexza's commercial partner for ADASUVE in the U.S.
Grupo Ferrer Internacional, S.A. is
Alexza's commercial partner for ADASUVE in Europe, Latin
America, Russia and the
Commonwealth of Independent States countries.
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, Inc.
Safe Harbor Statement
Alexza's policy is to provide guidance on product candidates
and corporate goals only 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 November 6, 2013 and financial
guidance relating to the Company's current cash, cash equivalents,
investments and restricted cash is based upon balances as of
September 30, 2013 and certain
subsequent events, including drawing down on the Teva Note.
This news release contains 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 of
Alexza and our partners, Teva and Ferrer, to effectively and
profitably commercialize ADASUVE, estimated product revenues and
royalties associated with the sale of 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)
(unaudited)
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
Revenue
|
$ 2,166
|
|
$
729
|
|
$46,530
|
|
$3,341
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
3,951
|
|
-
|
|
6,912
|
|
-
|
Research and
development
|
5,457
|
|
4,784
|
|
16,475
|
|
14,826
|
General and administrative
|
3,097
|
|
2,338
|
|
12,016
|
|
6,487
|
Total operating
expenses
|
12,505
|
|
7,122
|
|
35,403
|
|
21,313
|
|
|
|
|
|
|
|
|
(Loss) income from
operations
|
(10,339)
|
|
(6,393)
|
|
11,127
|
|
(17,972)
|
|
|
|
|
|
|
|
|
(Loss) gain on change
in fair value of contingent consideration liability
|
(1,613)
|
|
(200)
|
|
(44,013)
|
|
1,000
|
Interest and other
income (expense), net
|
1
|
|
5
|
|
18
|
|
413
|
Interest
expense
|
(461)
|
|
(333)
|
|
(1,055)
|
|
(1,146)
|
Net loss
|
$(12,412)
|
|
$(6,921)
|
|
$(33,923)
|
|
$(17,705)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.72)
|
|
$
(0.52)
|
|
$
(2.06)
|
|
$ (1.55)
|
ALEXZA
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
|
September
30,
|
December
31,
|
|
|
2013
|
2012(1)
|
ASSETS
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
23.807
|
$
17,715
|
|
Marketable
securities
|
8,650
|
-
|
|
Restricted
cash
|
-
|
5,051
|
|
Accounts
receivable
|
25
|
-
|
|
Inventory
|
2,061
|
-
|
|
Prepaid expenses and
other current assets
|
1,795
|
852
|
Total current
assets
|
36,338
|
23,618
|
|
|
|
|
Property and
equipment, net
|
15,507
|
16,531
|
Other
assets
|
1,727
|
402
|
Total
assets
|
$
53,572
|
$
40,551
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
Total current
liabilities
|
16,047
|
18,718
|
Total noncurrent
liabilities
|
57,473
|
19,260
|
Total stockholders'
(deficit) equity
|
(19,948)
|
2,573
|
Total liabilities
and stockholders' equity
|
$
53,572
|
$
40,551
|
|
|
|
|
(1) Derived from
audited consolidated financial statements at that date.
|
SOURCE Alexza Pharmaceuticals, Inc.