MOUNTAIN VIEW, Calif.,
Nov. 5, 2015 /PRNewswire/
-- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported
financial results for the quarter ended September 30, 2015. The net loss for the
third quarter was $5.4 million
compared to $13.3 million during the
same quarter in 2014. The net loss for the nine months ended
September 30, 2015 and 2014 was
$18.3 million and $30 million, respectively. At September 30, 2015, Alexza had consolidated cash
and cash equivalents of $11.3
million.
"We continue our efforts to increase the value of ADASUVE, our
pipeline, and of Alexza," said Thomas B.
King, President and CEO of Alexza Pharmaceuticals. "In
the last six months, we have moved to decrease our costs,
reposition our management team, secure financing and have engaged
Guggenheim to explore strategic options."
King continued, "We concluded our near term ADASUVE commercial
manufacturing in August, having successfully produced more than
110,000 units in our 2015 production campaign. Following this
work, we suspended our commercial manufacturing operations and
expect to realize significant cost savings beginning in the fourth
quarter."
King concluded, "We recently announced our plans to reacquire
the ADASUVE U.S. commercial rights from Teva. We continue to
remain confident in the long-term commercial prospects for ADASUVE
and over the course of the next few months, we will evaluate all of
our options and pursue the strategy that we believe will allow us
to maximize value for our stockholders."
Alexza Business Updates
- In September, Grupo Ferrer
Internacional, S.A. (Ferrer) and Alexza provided an ADASUVE
update on commercial activities in Europe and Latin America. Key highlights
included:
- ADASUVE is now available in 283 hospital settings in the EU,
compared to approximately 160 hospitals one year ago, an increase
of 77%.
- ADASUVE has experienced continued sustained growth in product
sales. Unit sales during the first half of 2015 were more
than 6 times the number of ADASUVE units sold in the first half of
2014.
- Alexza and Ferrer continue to receive strong and consistent
feedback from healthcare professionals across all countries in
Europe. Countries with routine use of ADASUVE include
Germany, Romania, Sweden, Norway, Finland, Denmark and Spain. The rest of the EU
countries, where ADASUVE is commercially available, are in the
process of listing the product in the hospital formularies, and
gaining initial trial and use with patients in hospitals in these
countries.
- Ferrer recently met with the EU regulatory authorities to
explore the potential modification of the ADASUVE label in
Europe to allow the use of the
product in the outpatient setting.
- In September 2015, Alexza
announced that it had retained Guggenheim Securities, LLC to assist
in exploring strategic options to enhance stockholder value,
including a possible sale or disposition of one or more corporate
assets, a strategic business combination, partnership or other
transactions.
- In September 2015, Alexza issued
a promissory note to Ferrer. The note provides that Ferrer will
loan Alexza up to $5 million in two
tranches: (i) the initial tranche of $3
million was received by Alexza on September 28, 2015 and (ii) Alexza has the option
to borrow the second tranche of $2
million at any time on or after January 1, 2016. The note bears interest at
6% per annum and all outstanding principal and accrued interest is
due and payable upon Ferrer's demand on May
31, 2016. Alexza issued 125,000 shares of its common
stock to Ferrer as additional consideration for the loan.
- In October 2015, Alexza announced
its plans to reacquire the U.S. rights for ADASUVE from Teva
Pharmaceuticals USA, Inc. (Teva),
a subsidiary of Teva Pharmaceutical Industries Ltd., with an
estimated target completion date of January
1, 2016. Alexza and Teva also plan to restructure the
obligations under the outstanding note from Teva. Alexza and
Teva are working on a transition agreement to continue product
availability to patients and health care providers after the return
of the rights to Alexza.
- In October 2015, Alexza announced
two management promotions. Catherine
McAuliffe was promoted to the newly created position of Vice
President, Operations, and Stacy
Palermini was promoted to Vice President, Finance. Ms.
Palermini is also Alexza's Corporate Secretary and Treasurer.
Thomas B. King, President and CEO,
was named as Alexza's Principal Accounting Officer and Principal
Financial Officer.
- Alexza's Phase 2a clinical trial of AZ-002 (Staccato
alprazolam) is 50% enrolled. AZ-002 is being developed for
the management of epilepsy patients with acute repetitive seizures,
sometimes called cluster seizures, or ARS. The study is being
conducted at three clinical sites, and two new sites are being
initiated. The Company expects to complete this study in the
fourth quarter of 2015.
- During the second and third quarters of 2015, Alexza and Ferrer
successfully conducted three GMP inspections of the Alexza
manufacturing facility that provides ADASUVE for countries within
the European Union, Latin America,
Korea, Philippines, Thailand, countries in the Commonwealth of
Independent States and the Middle
East and North Africa,
including inspections by EMA (EU), ANVISA (Brazil) and TITCK (Turkey). These inspections are part of
the ongoing regulatory review processes for ADASUVE.
Financial Results - Periods Ended September 30, 2015 and 2014
Alexza recorded revenue of $1.8
million and $4.4 million in
the three and nine months ended September
30, 2015, respectively, compared to $0.54 million and $4.1
million in the same periods in 2014, respectively.
|
Three Months
Ended
|
|
Nine Months
Ended
|
September
30,
|
|
September
30,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Product
revenue
|
$
|
1,061
|
|
$
|
93
|
|
$
|
2,394
|
|
$
|
1,646
|
Milestone
revenue
|
-
|
|
-
|
|
-
|
|
1,000
|
Amortization of
upfront payments
|
712
|
|
364
|
|
1,954
|
|
1,457
|
Royalty
revenue
|
-
|
|
-
|
|
5
|
|
4
|
Total
revenues
|
$
|
1,773
|
|
$
|
457
|
|
$
|
4,353
|
|
$
|
4,107
|
Operating expenses were $9.4
million and $10.5 million in
the three months ended September 30,
2015 and 2014, respectively, and $34.4 million and $34.3
million for the nine months ended September 30, 2015 and 2014, respectively.
During 2013 and 2014, Alexza completed production of ADASUVE for
commercial launch and initial stocking, which did not utilize
Alexza's full manufacturing capacity. In collaboration with Teva
and Ferrer, Alexza conducted an analysis to evaluate
forward-looking demand for the product and cost-effective
strategies for ADASUVE commercial production. The analysis included
supply chain requirements, production volume and timelines, batch
sizes and possible scenarios to make global production more
efficient and cost-effective. Earlier this year, 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. Through the third
quarter of 2015, Alexza produced approximately 110,000 units of
ADASUVE which completed the fulfillment of the Teva and Ferrer
orders. Alexza has completed the suspension of the ADASUVE
commercial production operations and plan to resume commercial
production in the future, as additional commercial product is
required by Ferrer or any future collaborators. We may also
consider contracting with third party manufacturers for ADASUVE
units if deemed more efficient, including third-party manufacturers
with multi-product facilities.
In addition to reductions in the commercial production
operations, Alexza focused on reductions to its research and
development and general and administrative functions. Research and
development expenses were $2.5
million and $10.0 million
during the three and nine months ended September 30, 2015, respectively, and
$3.4 million and $10.6 million in the same periods in 2014,
respectively.
General and administrative expenses were $3.2 million and $10.4
million during the three and nine months ended September 30, 2015 and $3.8 million and $11.8
million in the same periods in 2014, respectively.
Alexza believes that, based on its cash and cash equivalents
balances at September 30, 2015, available proceeds under the
Ferrer bridge loan, and Alexza' expected cash usage, it has
sufficient capital resources to meet its anticipated cash needs
into the second quarter of 2016. 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 November 5,
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:
1-844-492-3732 or +1-412-542-4199
(international)
Passcode: Please request the Alexza Pharmaceuticals conference
call
REPLAY:
1-877-344-7529 or +1-412-317-0088
(international)
Passcode: 10074639
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 is
currently available in 20 countries, 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 current commercial
partner for ADASUVE in the United
States, though Alexza has announced its intention to
reacquire the United States
commercial rights from Teva with an estimated target completion
date of January 1, 2016. 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. For more
information about Alexza, the Staccato system technology or
the Company's development programs, please visit
www.alexza.com.
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 5, 2015 and financial guidance relating
to the Company's current cash, cash equivalents, and marketable
securities is based upon balances as of September 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 Ferrer to effectively and profitably commercialize
ADASUVE, Alexza's ability to secure a new U.S. commercial partner
for ADASUVE and the terms of any such partnership, 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.
Additionally, there are risks and uncertainties inherent in the
process of negotiating the acquisition of the U.S. rights for
ADASUVE from Teva and restructuring the obligations under the
outstanding note from Teva. Alexza does not have a defined timeline
for this process and is not confirming that the process will result
in any specific action or transaction. 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
|
|
September
30,
|
|
September
30,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Collaboration
revenue
|
$ 712
|
|
$ 364
|
|
$ 1,959
|
|
$ 2,461
|
Product
sales
|
1,061
|
|
93
|
|
2,394
|
|
1,646
|
Total
revenue
|
1,773
|
|
457
|
|
4,353
|
|
4,107
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
3,675
|
|
3,279
|
|
13,954
|
|
11,973
|
Research
and development
|
2,463
|
|
3,391
|
|
10,048
|
|
10,553
|
General
and administrative
|
3,232
|
|
3,827
|
|
10,392
|
|
11,773
|
Total operating
expenses
|
9,370
|
|
10,497
|
|
34,394
|
|
34,299
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(7,597)
|
|
(10,040)
|
|
(30,041)
|
|
(30,192)
|
|
|
|
|
|
|
|
|
(Loss)/gain on change
in fair value of contingent consideration liability
|
4,200
|
|
(1,100)
|
|
18,232
|
|
5,349
|
Interest and other
income/ (expense), net
|
(72)
|
|
14
|
|
(87)
|
|
22
|
Interest
expense
|
(1,969)
|
|
(2,202)
|
|
(6,396)
|
|
(5,204)
|
Net loss
|
$ (5,438)
|
|
$ (13,328)
|
|
$ (18,292)
|
|
$ (30,025)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$ (0.27)
|
|
$ (0.77)
|
|
$ (0.93)
|
|
$ (1.73)
|
ALEXZA
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (in thousands)
(unaudited)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2015
|
|
2014(1)
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
11,287
|
|
$
15,200
|
|
Marketable
securities
|
-
|
|
19,574
|
|
Receivables
|
822
|
|
173
|
|
Inventory
|
103
|
|
3,729
|
|
Prepaid expenses and
other current assets
|
1,212
|
|
3,109
|
Total current
assets
|
13,424
|
|
41,785
|
|
|
|
|
|
Property and
equipment, net
|
10,301
|
|
13,953
|
Restricted
cash
|
-
|
|
2,757
|
Other
assets
|
2,497
|
|
3,065
|
Total
assets
|
$
26,222
|
|
$
61,560
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
|
|
|
Total current
liabilities
|
13,313
|
|
11,517
|
Total noncurrent
liabilities
|
81,758
|
|
101,696
|
Total stockholders'
deficit
|
(68,849)
|
|
(51,653)
|
Total liabilities and
stockholders' deficit
|
$
26,222
|
|
$
61,560
|
|
|
(1)
|
Derived from the
audit financial statements on that date.
|
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SOURCE Alexza Pharmaceuticals, Inc.