MOUNTAIN VIEW, Calif.,
March 9, 2015 /PRNewswire/ -- Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported financial
results for the quarter and year ended December 31, 2014. The net loss for the
fourth quarter was $6.7 million
compared to $5.7 million during the
same quarter in 2013. The net loss for the years ended
December 31, 2014 and 2013 was
$36.7 million and $39.6 million, respectively. At
December 31, 2014, Alexza had
consolidated cash, cash equivalents, marketable securities, and
restricted cash of $37.5 million.
"During 2015 and beyond, we see several value opportunities for
Alexza," said Thomas B. King,
President and CEO of Alexza. "We believe we will see
continued uptake of ADASUVE® , based on the foundation
established by Teva in the U.S., and Ferrer in the EU and Latin
America. Teva and Ferrer continue to make progress with the
number of hospitals and physicians utilizing ADASUVE. We
continue to feel confident about the long-term potential of
ADASUVE, given the satisfaction we hear from doctors and patients
who have used the product and found it to be safe and
effective."
King continued, "Beyond ADASUVE, we are excited about our
evolving pipeline, with a goal of deriving value from our
Staccato® technology. We have two product
candidates in active development. We initiated a Phase 2a
study with AZ-002 (Staccato alprazolam) in a subset of
epilepsy patients. Additionally, in 2015 we expect to
commence a Phase 2 clinical trial with AZ-007 (Staccato
zaleplon) for the treatment of middle of night awakening."
Alexza Business Updates
- During the fourth quarter, Ferrer began marketing ADASUVE in
three additional EU countries, bringing the total to 12 countries
where ADASUVE is being marketed in the EU. As of March 2015, Ferrer has received ADASUVE approval
in seven Latin American countries and currently markets the product
in Guatemala. Ferrer anticipates additional EU Member States
and Latin American country approvals and launches in 2015 and
2016.
- During the fourth quarter, Teva continued its commercial
efforts with ADASUVE in the U.S., increasing the number of
hospitals who have completed the pharmacy & therapeutics
committee review process and/or the REMS enrollment process.
- In December 2014, Alexza amended
its commercial Manufacturing and Supply Agreement with Autoliv ASP,
Inc. Autoliv manufactures chemical heat packages, a key
component of Alexza's single-dose Staccato system, including
ADASUVE. The Amendment nullified the letter of termination
received by Alexza in October 2013
and the parties extended the agreement through 2018. In
addition, Alexza has the right to engage a second source supplier
and implement a manufacturing line transfer to manufacture and
supply the chemical heat packages from Autoliv to Alexza or
its licensees.
- In December 2014, Alexza and
Ferrer announced that the Spanish-based publication Diario Médico
included ADASUVE in its "Best Ideas of 2014" awards. The Best
Ideas awards by Diario Médico acknowledge the daily work of
persons, institutions or enterprises that contributed to the
improvement of medicine, healthcare, and public health during the
previous year.
- In January 2015, 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 (ARS). ARS occurs in a subset of
patients with epilepsy who regularly experience breakthrough
seizures, despite treatment with a regular regimen of
anti-epileptic drugs.
- Alexza has reinvigorated the AZ-007 (Staccato zaleplon)
program in its product development pipeline. AZ-007 is being
developed for the treatment of insomnia in patients who have
difficulty falling asleep, including those patients with middle of
the night awakening who have difficulty falling back asleep.
The Company plans to initiate a Phase 2 clinical study with AZ-007
in 2015.
- Alexza is developing the next-generation of the Staccato
platform, a "smart" Staccato intended to take advantage of
the current electronics in the single and multiple dose platforms
and those that could be added. These smart features can be
incorporated into Alexza's current product candidate pipeline,
including AZ-002 and AZ-007.
Financial Results - Periods Ended December 31, 2014 and 2013
Alexza recorded revenues of $1.5
million and $5.6 million in
the quarter and year ended December 31,
2014, respectively, compared to $1.3
million and $47.8 million in
the same periods in 2013, respectively. Revenues consist of:
i) product sales from units of ADASUVE sold to Teva and Ferrer, ii)
the amortization of the upfront payments received from Ferrer, iii)
milestone revenues from Ferrer, iv) royalty revenues from Teva for
U.S. sales and v) licensing revenues.
Revenues for the quarter and year ended December 31, 2014 and 2013 were as follows (in
thousands):
|
Q4
|
Q4
|
|
YTD
|
YTD
|
|
2014
|
2013
|
|
2014
|
2013
|
Product
sales
|
$ 918
|
$ 580
|
|
$ 2,564
|
$ 874
|
Amortization of
upfront payments
|
530
|
729
|
|
1,987
|
2,915
|
Milestone
revenue
|
-
|
-
|
|
1,000
|
1,250
|
Royalty
revenue
|
6
|
-
|
|
10
|
-
|
License
revenue
|
-
|
-
|
|
-
|
42,800
|
Total
revenues
|
$ 1,454
|
$ 1,309
|
|
$ 5,561
|
$ 47,839
|
GAAP operating expenses were $8.7
million and $43.0 million in
the quarter and year ended December 31,
2014, respectively, and $10.7
million and $46.1 million in
the same periods in 2013, respectively.
Cost of goods sold were $4.0
million and $15.9 million
during the quarter and year ended December
31, 2014, compared to $4.3
million and $11.2 million in
the same periods in 2013, respectively. 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 normal manufacturing capacity. The decrease in the
fourth quarter of 2014 as compared to the fourth quarter of 2013
was a result of a reduction in production costs to adjust for
current demand requirements. All costs associated with the
manufacturing process incurred prior to the first commercial
product produced in the second quarter of 2013 were expensed as a
component of research and development expense.
In 2014, Alexza shipped 21,209 units of ADASUVE to Ferrer for
the EU and Latin American markets and 74,097 to Teva for the U.S.
market. In 2013, Alexza shipped 27,638 units of ADASUVE to
Ferrer and 9,307 units of ADASUVE to Teva.
Research and development expenses were $3.2 million in the quarter and $13.7 million in the year ended December 31, 2014, compared to $2.6 million and $19.1
million in the same periods in 2013, respectively. The
decrease in 2014 was partially a result of expenses that related to
quality and manufacturing being classified as cost of goods sold or
inventory beginning in the second quarter of 2013, rather than
research and development expenses. The increase in research and
development expenses during the fourth quarter of 2014, as compared
to 2013, was the result of costs associated with clinical studies
to meet EU post-approval commitments.
General and administrative expenses were $1.6 million in the quarter and $13.3 million in the year ended December 31, 2014, as compared to $3.8 million and $15.8
million in the same periods in 2013, respectively. The
decrease in 2014 as compared to 2013 was primarily due to the
reversal of share-based compensation expense related to equity
awards rescinded in the fourth quarter of 2014 and the reduction in
2014 of pre-commercialization efforts such as market research,
including pricing and market segmentation studies that incurred in
2013. Teva assumed these expenses after licensing commercialization
rights to ADASUVE in the U.S. in May
2013.
In connection with the exercise of Alexza's option to purchase
all of the outstanding equity of Symphony Allegro, Inc., or
Allegro, in 2009, Alexza is obligated to make contingent cash
payments to the former Allegro stockholders related to certain
payments received by Alexza from future collaboration agreements
pertaining to ADASUVE/AZ-104 (Staccato loxapine) or AZ-002
(Staccato alprazolam). In order to estimate the fair
value of the liability associated with the contingent cash
payments, Alexza prepared several cash flow scenarios for ADASUVE,
AZ-104 and AZ-002, which are subject to the contingent payment
obligation. Each potential cash flow scenario consisted of
assumptions of the range of estimated milestone and license
payments potentially receivable from such collaborations and
assumed royalties received from future product sales. Based
on these estimates, Alexza computed the estimated payments to be
made to the former Allegro stockholders. Payments were assumed to
terminate in accordance with current agreement terms or, if no
agreements exist, upon the expiration of the related patents.
In 2014, Alexza drew down the remaining $10.0 million available under the Teva note and
sold 2,000,000 shares of common stock to Ferrer for $8.0 million, which represents a combination of
new investment and consideration for the elimination of certain
future potential milestone payments. Alexza believes that,
based on its cash, cash equivalents, marketable securities and
restricted cash balances at December 31,
2014, estimated product revenues, milestone payments
associated with the sale of ADASUVE, and its current expected cash
usage, it has sufficient capital resources to meet its anticipated
cash needs into the fourth quarter of 2015. In light of its
ongoing costs, investments in ADASUVE manufacturing and product
candidate development, and its projected working capital needs,
Alexza expects to need to source additional capital to finance its
ongoing operations in the next twelve months. 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 March 9,
2015
To access the webcast via the Internet, go to www.alexza.com, under
the "Investors" 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: 10061036
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 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®, Alexza's first commercial product, is based
on the Staccato system and has been approved for sale by the
U.S. Food and Drug Administration, the European Commission,
and in several Latin American countries. ADASUVE is currently
being marketed in twelve EU member countries, the United States, and one country in Latin
America.
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, and the Commonwealth of
Independent States countries.
ADASUVE® and Staccato® are registered
trademarks of Alexza Pharmaceuticals, Inc. For more
information, please visit www.alexza.com.
Safe Harbor Statement
The anticipated news release
and 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 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, 2013 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
December 31,
|
|
Year
Ended
December 31,
|
|
2014
|
2013
|
|
2014
|
2013
|
Revenue
|
$1,454
|
$1,309
|
|
$5,561
|
$47,839
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Cost of goods
sold
|
3,952
|
4,297
|
|
15,925
|
11,209
|
Research and
development
|
3,195
|
2,607
|
|
13,748
|
19,082
|
General and
administrative
|
1,571
|
3,762
|
|
13,344
|
15,778
|
Total operating
expenses
|
8,718
|
10,666
|
|
43,017
|
46,069
|
Loss from
operations
|
(7,264)
|
(9,357)
|
|
(37,456)
|
1,770
|
Change in fair value
of contingent consideration liability
|
2,800
|
4,100
|
|
8,149
|
(39,913)
|
Interest and other
income/expense, net
|
(9)
|
8
|
|
13
|
26
|
Interest
expense
|
(2,234)
|
(443)
|
|
(7,438)
|
(1,498)
|
Net
loss
|
$
(6,707)
|
$(5,692)
|
|
$(36,732)
|
$(39,615)
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.35)
|
$
(0.33)
|
|
$
(2.07)
|
$
(2.38)
|
|
ALEXZA
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
December 31,
|
|
2014
|
2013
|
ASSETS
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$ 15,200
|
$ 17,306
|
Marketable
securities
|
19,574
|
8,578
|
Receivables
|
173
|
129
|
Inventory
|
3,729
|
3,447
|
Prepaid expenses and
other current assets
|
3,109
|
1,453
|
Total current
assets
|
41,785
|
30,913
|
Property and
equipment, net
|
13,953
|
14,991
|
Restricted
cash
|
2,757
|
-
|
Other
assets
|
3,065
|
1,168
|
Total
assets
|
$
61,560
|
$
47,072
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
|
|
Total current
liabilities
|
11,517
|
14,898
|
Total noncurrent
liabilities
|
101,696
|
56,149
|
Total stockholders'
deficit
|
(51,653)
|
(23,975)
|
Total liabilities and
stockholders' deficit
|
$
61,560
|
$
47,072
|
|
|
|
Logo -
http://photos.prnewswire.com/prnh/20140121/SF49110LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/alexza-reports-fourth-quarter-and-year-end-2014-financial-results-300047663.html
SOURCE Alexza Pharmaceuticals, Inc.