MOUNTAIN VIEW, Calif.,
Aug. 6, 2015 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported
financial results for the quarter ended June
30, 2015. The net loss for the second quarter was
$12.5 million compared to
$6.0 million during the same quarter
in 2014. The net loss for the six months ended June 30, 2015 and 2014 was $12.9 million and $16.7
million, respectively. At June
30, 2015, Alexza had consolidated cash, cash equivalents,
and marketable securities of $15.7
million.
"We continue to see the incremental growth in the ADASUVE global
launch. ADASUVE is now available in 18 countries and we see
continued increases in the number of hospitals stocking and using
the product," said Thomas B. King,
President and CEO of Alexza Pharmaceuticals. "Importantly, we
believe the sales during the ADASUVE launch do not reflect the
clinical benefits ADASUVE can convey to patients, and we remain
confident in ADASUVE's long-term commercial prospects.
Feedback from physicians and patients corroborate the positive
clinical profile we observed with ADASUVE during its clinical
development."
King continued, "Earlier this year we embarked on a plan to
change our commercial production strategy to reduce our cash burn
rate. We are pleased to have made substantial progress on this
plan, including the recent amendments to our Teva and Ferrer
agreements. These changes will allow us to reduce the near
term spending on ADASUVE production and eliminate the costs
associated with some of the EU post-approval commitments, helping
us progress on our goal of substantially reducing our cash
use."
King concluded, "Importantly, we remain focused on driving value
in Alexza, including seeking additional collaborations for ADASUVE
in available markets and working diligently on partnering our
validated Staccato platform technology for new product
opportunities."
Alexza Business Updates
- In April, Alexza announced the promotions of Dr. Edwin S. Kamemoto to the newly created position
of Executive Vice President, R&D and Quality, and Dr.
Lori H. Takahashi to the newly
created position of Vice President, Pharmaceutical R&D and
Quality.
- In May 2015, Alexza identified
initiatives to reduce Alexza's underutilized commercial production
capacity, while fulfilling the supply requirements of its
commercial partners. Teva and Ferrer provided longer-term ADASUVE
orders, allowing Alexza to manufacture ADASUVE in a consistent
manner to take advantage of the efficiencies of continued batch
production. Alexza plans to produce ADASUVE until August 2015. Once orders are filled and shipped,
it is Alexza's intention to suspend ADASUVE commercial production
operations. Alexza anticipates that total ADASUVE production for
2015 will be approximately 110,000 units.
- In June, Alexza announced that it has updated and amended its
ADASUVE commercial collaborations with Grupo Ferrer Internacional, S.A. (Ferrer) and
Teva Pharmaceutical Industries Ltd. (Teva). Ferrer is Alexza's
commercial partner for ADASUVE in the European Union, Latin America, the Commonwealth of Independent
countries, the Middle East and
North Africa countries, Korea,
Philippines, and Thailand. Teva is Alexza's commercial partner
for ADASUVE in the United
States.
- Teva and Alexza completed enrollment in their clinical study to
assess the safety and pharmacokinetics of ADASUVE at doses of 2.5,
5 and 10 mg in 30 adolescents. Teva expects to file the clinical
study report later in 2015 with the U.S. Food and Drug
Administration. Teva and Alexza believe that data from this Phase 1
study will provide dosing information for follow-on efficacy and
safety studies in adolescents.
- During the first quarter, Alexza initiated a Phase 2a study of
AZ-002 (Staccato alprazolam), which is being developed for
the management of epilepsy in patients with acute repetitive
seizures. The study is ongoing and data from this study is expected
later in 2015.
Financial Results - Periods Ended June
30, 2015 and 2014
Alexza recorded revenue of $1.9
million and $2.6 million in
the three and six months ended June 30,
2015, respectively, compared to $1.5
million and $3.7 million in
the same periods in 2014, respectively.
|
Three Months
Ended
|
|
Six Months
Ended
|
June
30,
|
|
June
30,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Product
revenue
|
$ 1,245
|
|
$ 1,116
|
|
$ 1,332
|
|
$ 1,553
|
Milestone
revenue
|
-
|
|
-
|
|
-
|
|
1,000
|
Amortization of
upfront payments
|
630
|
|
364
|
|
1,242
|
|
1,093
|
Royalty
revenue
|
-
|
|
4
|
|
6
|
|
4
|
Total
revenues
|
$ 1,875
|
|
$ 1,484
|
|
$ 2,580
|
|
$ 3,650
|
|
|
|
|
|
|
|
|
Operating expenses were $11.3
million and $12.8 million in
the three months ended June 30, 2015
and 2014, respectively, and $25.0
million and $23.8 million for
the six months ended June 30, 2015
and 2014, respectively.
Cost of goods sold consists mainly of excess manufacturing costs
during the period, in addition to the cost of the units
shipped. Alexza is in the early stages of commercialization
and, as anticipated, has incurred higher cost per unit costs
associated with low production volumes. All costs
associated with the manufacturing process incurred prior to the
first commercial product produced in the second quarter of 2014
were expensed as a component of research and development
expense.
Research and development expenses were $3.8 million and $7.6
million during the three and six months ended June 30, 2015, respectively, and $4.0 million and $7.2
million in the same periods in 2014, respectively.
General and administrative expenses were $3.4 million and $7.2
million during the three and six months ended June 30, 2015 and $3.9
million and $7.9 million in
the same periods in 2014, respectively.
Alexza believes that with current cash, cash equivalents and
marketable securities balances, estimated product revenues,
milestone payments associated with the sale of ADASUVE, and the
Company's expected cash usage, it has sufficient capital resources
to meet its anticipated cash needs at anticipated cost levels into
the fourth quarter of 2015. Changing circumstances may cause Alexza
to consume capital significantly faster or slower than it currently
anticipates, or to alter its operations.
Conference Call Information - 5:00 p.m.
Eastern Time on August 6,
2015
To access the webcast via the Internet, go to www.alexza.com, under
the "Investor Relations" link. Please log onto the webcast
prior to the start of the call to ensure time for any software
downloads that may be required to participate in the
webcast.
LIVE CALL:
1-877-870-4263 or +1-412-317-0790
(international)
Passcode: Please request the Alexza Pharmaceuticals conference
call
REPLAY:
1-877-344-7529 or +1-412-317-0088
(international)
Passcode: 10068753
A replay of the conference call may also be accessed at
www.alexza.com under the "Investors" link. A replay of the
call will be available for 7 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 and development pipeline are based on the
Staccato® system, a hand-held inhaler designed to
deliver a pure drug aerosol to the deep lung, providing rapid
systemic delivery and therapeutic onset, in a simple, non-invasive
manner. Active pipeline product candidates include AZ-002
(Staccato alprazolam) for the management of epilepsy in
patients with acute repetitive seizures and AZ-007 (Staccato
zaleplon) for the treatment of patients with middle of the night
insomnia.
ADASUVE® is Alexza's first commercial product and has
been approved for sale by the U.S. Food and Drug Administration,
the European Commission and in several Latin American
countries. Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical
Industries Ltd., is Alexza's commercial partner for ADASUVE in the
United States. Grupo Ferrer Internacional SA is Alexza's
commercial partner for ADASUVE in Europe, Latin
America, the Commonwealth of Independent States countries,
the Middle East and North Africa countries, Korea, Philippines and Thailand.
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 August 6, 2015 and financial
guidance relating to the Company's current cash, cash equivalents,
and marketable securities is based upon balances as of June 30, 2015.
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 its 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, 2014 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 LOSS AND COMPREHENSIVE
LOSS
(in thousands, except
per share amounts)
(unaudited)
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
June
30,
|
|
June
30,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Collaboration
revenue
|
$ 629
|
|
$ 368
|
|
$ 1,247
|
|
$ 2,097
|
Product
sales
|
1,246
|
|
1,116
|
|
1,333
|
|
1,553
|
Total
revenue
|
1,875
|
|
1,484
|
|
2,580
|
|
3,650
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
4,132
|
|
4,903
|
|
10,279
|
|
8,694
|
Research and development
|
3,761
|
|
4,032
|
|
7,585
|
|
7,162
|
General and administrative
|
3,423
|
|
3,898
|
|
7,160
|
|
7,946
|
Total operating
expenses
|
11,316
|
|
12,833
|
|
25,024
|
|
23,802
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(9,441)
|
|
(11,349)
|
|
(22,444)
|
|
(20,152)
|
|
|
|
|
|
|
|
|
(Loss)/gain on change
in fair value of contingent consideration liability
|
(801)
|
|
7,599
|
|
14,032
|
|
6,449
|
Interest and other
income/ (expense), net
|
(10)
|
|
2
|
|
(15)
|
|
8
|
Interest
expense
|
(2,198)
|
|
(2,214)
|
|
(4,427)
|
|
(3,002)
|
Net loss
|
$ (12,450)
|
|
$ (5,962)
|
|
$ (12,854)
|
|
$ (16,697)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$ (0.63)
|
|
$ (0.34)
|
|
$ (0.65)
|
|
$ (0.96)
|
ALEXZA
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2015
|
|
2014(1)
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$12,193
|
|
$15,200
|
|
Marketable
securities
|
3,503
|
|
19,574
|
|
Receivables
|
303
|
|
173
|
|
Inventory
|
1,407
|
|
3,729
|
|
Prepaid expenses and
other current assets
|
1,565
|
|
3,109
|
Total current
assets
|
18,971
|
|
41,785
|
|
|
|
|
|
Property and
equipment, net
|
11,014
|
|
13,953
|
Restricted
cash
|
-
|
|
2,757
|
Other
assets
|
2,648
|
|
3,065
|
Total
assets
|
$32,633
|
|
$61,560
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
|
|
|
Total current
liabilities
|
$10,008
|
|
$11,517
|
Total noncurrent
liabilities
|
86,535
|
|
101,696
|
Total stockholders'
deficit
|
(63,910)
|
|
(51,653)
|
Total liabilities and
stockholders' equity
|
$32,633
|
|
$61,560
|
|
|
|
|
|
(1)
|
Derived from the
audited financial statements on that date.
|
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SOURCE Alexza Pharmaceuticals, Inc.