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8-K - FORM 8-K - Alexza Pharmaceuticals Inc. | d82164e8vk.htm |
Exhibit 99.1
NEWS RELEASE for immediate release
Alexza Reports 2011 First Quarter Financial Results
and Provides Business Update
and Provides Business Update
AZ-004 (Staccato® Loxapine) NDA Target Resubmission Date of July 2011
Conference Call Scheduled Today for 4:30 p.m. Eastern Time
Mountain View, California May 9, 2011 - Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today
reported financial results for the fiscal quarter ended March 31, 2011, and provided a business
update. The net loss for the quarters ended March 31, 2011 and 2010, as reported in accordance
with accounting principles generally accepted in the United States, was $8.4 million and $13.4
million, respectively. At March 31, 2011, Alexza had consolidated cash, cash equivalents and
marketable securities of $31.8 million. Subsequent to the end of the first quarter, the Company
completed a Type-C meeting with the FDA regarding a draft Risk Evaluation and Mitigation Strategy
(REMS) program for AZ-004 and completed a registered direct offering with net proceeds of
approximately $15.8 million.
The start of 2011 has been highly productive for Alexza. The primary emphasis has been our
continued work in preparing the AZ-004 NDA for re-submission to the FDA and the AZ-004 MAA for
submission to the EMA, said Thomas B. King, President and CEO of Alexza. As outlined previously
and based on additional guidance received from the FDA, we believe the issues raised in the AZ-004
Complete Response Letter are resolvable and we remain on track to re-file the AZ-004 NDA in late
July this year.
King continued, In early March, we were approached by investors with the strategic view of
strengthening our balance sheet and extending our operating runway. Our recent capital raise
provides Alexza with the operational flexibility to continue our AZ-004 partnering discussions and
operate the Company beyond what we believe will be the timing of our new AZ-004 PDUFA date early
next year.
Alexza Business Update
The following key events, listed in chronological order, occurred since the beginning of the first
quarter of 2011:
| In January 2011, Alexza received the FDA minutes from the End-of-Review meeting with the FDA for the AZ-004 NDA in December 2010. Based on the guidance received at the End-of-Review meeting, the Company believes the issues raised in the Complete Response Letter (CRL) are resolvable and Alexza anticipates resubmitting its AZ-004 NDA in July 2011. |
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| On February 22, 2011, the Company completed a voluntary employee stock option exchange program to permit the Companys eligible employees to exchange some or all of their outstanding options to purchase the Companys common stock for a lesser number of new stock options with a new vesting period. Stock options to purchase an aggregate of 2,128,430 shares of the Companys common stock, with exercise prices ranging from $2.38 to $11.70, were exchanged for stock option to purchase an aggregate of 808,896 shares of the Companys common stock with an exercise price of $1.23 per share. | |
| Alexza announced that the British Journal of Psychiatry, a publication of the Royal College of Psychiatrists, in its January 2011 edition (198:51-58), published the results of the pivotal Phase 3 study evaluating AZ-004 (inhaled or Staccato loxapine) for the rapid treatment of agitation in patients with schizophrenia. | |
| In April 2011, Alexza completed a Type C meeting with the FDA. The primary purpose of this meeting was to discuss preliminary draft labeling and initial REMS program proposals. The FDA granted this meeting at the Companys request, as a follow-on activity to discussions during Alexzas End-of-Review meeting held in December 2010. In the information package submitted to the FDA in preparation for this guidance meeting, Alexza included updated draft labeling and a medication guide, and initial proposals for an AZ-004 REMS program, including a draft communication plan and draft post-approval study outline. | |
Following the REMS guidance meeting in April 2011, Alexza believes there is agreement with the FDA on the definition of the potentially at-risk patient population. Additionally, Alexza and the FDA discussed key elements of screening for these at-risk patients, noting that no screen is 100% effective, and components to post-dosing risk mitigation in the event an at-risk patient receives a dose of AZ-004. The FDA emphasized that there are two key components for a risk mitigation proposal: i) adequacy of monitoring, via patient observation, for a period of time relative to the likely occurrence of a respiratory adverse reaction, and ii) availability of rescue medication (e.g., inhaled albuterol) should an adverse reaction occur. | ||
Alexza will address this updated guidance from the FDA in its draft REMS proposal contained within the AZ-004 NDA resubmission. The FDA indicated that a complete review of the proposed REMS in conjunction with the full clinical review of the resubmitted NDA will be necessary to determine whether the REMS will be acceptable. The FDA stated it would present the AZ-004 application to an Advisory Committee. The objective of this Advisory Committee meeting would be to discuss the proposed approach for managing the risks of AZ-004 in relationship to its patient benefits. | ||
Alexza notes that it has not received the official FDA meeting minutes from the REMS guidance meeting. The summaries in this release may be altered or supplemented by the information contained in the official meeting minutes. The Company will provide further U.S. regulatory updates on AZ-004 |
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after receipt of the official FDA minutes or other correspondence if there are material developments in such minutes or correspondence. | ||
| Alexza previously received notice that AZ-004 is eligible for submission of a Marketing Authorization Application (MAA) under the centralized registration procedure with the European Medicines Agency (EMA) and was also notified of the Rapporteur and co-Rapporteur appointments for the AZ-004 review. The Company has confirmed a filing target date with the EMA and plans to submit the MAA late in the third quarter of 2011. | |
| On May 6, 2011, the Company issued an aggregate of 11,927,034 shares of its common stock and warrants to purchase up to an additional 4,174,457 shares of its common stock in a registered direct offering. Net proceeds from the offering were approximately $15.8 million, after deducting estimated offering expenses. The warrants will be exercisable six months after issuance at $1.755 per share and will expire five years from the date of issuance. The shares of common stock and warrants are immediately separable and will be issued separately. The securities were sold pursuant to a shelf registration statement declared effective by the SEC on May 20, 2010. | |
Alexza believes that, based on its cash, cash equivalents and marketable securities balance at March 31, 2011, the net proceeds from the May financing, and the Companys expected cash usage, it has sufficient capital resources to meet its anticipated cash needs into the first quarter of 2012. Changing circumstances may cause Alexza to consume capital significantly faster or slower than currently anticipated, or to alter its operations. |
Financial Results Periods Ended March 31, 2011 and 2010
Alexza recorded $1.3 million of revenues in the quarter ended March 31, 2011, and no revenues in
the quarter ended March 31, 2010. The 2011 revenues are a result payments received under the
license agreement with Cypress Biosciences, Inc.
Operating expenses were $9.1 million and $12.6 million in the quarters ended March 31, 2011 and
2010, respectively. Research and development expenses were $6.3 million and $7.6 million in the
quarters ended March 31, 2011 and 2010, respectively. General and administrative expenses were
$2.8 million and $5.1 million in the quarters ended March 31, 2011 and 2010, respectively.
Expenses in 2010 included a one-time, non-cash charge of $1.1 million related to Alexza entering
into a sublease agreement for a portion of one of its Mountain View facilities.
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 AZ-004, 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 did not record a non-operating gain or loss during
the first quarter of 2011 as compared to a non-operating loss of $0.7 million in the quarter ended
March 31, 2010. Gains and losses incurred
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reflect Alexzas change in the estimated
probability-weighted cash flows from AZ-004 and the estimated timing of receipt of such cash flows.
Conference Call Information
To access the conference call via the Web, please go to the Investor Relations tab at
www.alexza.com. 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=PVNFWTCCE. A replay of the
call will be available for two weeks following the event.
To access the live conference call via phone, dial 888-713-4214. International callers may access
the live call by dialing 617-213-4866. The reference number to enter the call is 57197688.
The replay of the conference call may be accessed via the Web, at www.alexza.com, or via phone at
888-286-8010 for domestic callers or 617-801-6888 for international callers.
The reference number for the replay of the call is 13602576.
About Alexza Pharmaceuticals, Inc.
Alexza is a pharmaceutical company focused on the research, development and commercialization of
novel, proprietary products for the acute treatment of central nervous system conditions. Alexzas
technology, the Staccato® system, vaporizes unformulated drug to form a condensation
aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.
The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic
onset that is comparable to intravenous administration, but with greater ease, patient comfort and
convenience. (Click here to see an animation of how the Staccato system works.)
AZ-004 (Staccato loxapine) is Alexzas lead program, which is being developed for the rapid
treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and
announced positive results from both of its AZ-004 Phase 3 clinical trials and submitted the AZ-004
NDA in December 2009. In October 2010, the Company received a CRL from the FDA, regarding its NDA
for AZ-004. A CRL is issued by FDAs Center for Drug Evaluation and Research indicating that the
NDA review cycle is complete and the application is not ready for approval in its present form.
The Company completed an end-of-review meeting with the FDA in December 2010 and a REMS guidance
meeting with the FDA in April 2011.
The Company believes it has a clear understanding of the issues outlined in the CRL, is developing
and executing a plan to address these issues, and currently projects a resubmission of the AZ-004
NDA in July 2011.
For more information about Alexza, the Staccato technology or the Companys development programs,
please visit www.alexza.com.
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Safe Harbor Statement
Alexzas 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 May 9, 2011 and financial guidance relating to the
Companys current cash, cash equivalents and investments is based upon balances as of March 31,
2011, plus the net proceeds from the equity offering completed in May 2011.
This news release and anticipated conference call will contain forward-looking statements that
involve significant risks and uncertainties. Any statement describing the Companys 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 adequacy of the Companys capital to support the Companys
current operations through the projected timeframe, the potential of the Companys planned AZ-004
NDA resubmission to adequately address the issues in the CRL, the eventual prospects that AZ-004
will be approved for marketing and the timing of the Companys resubmission of the AZ-004 NDA to
the FDA. The Companys 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 Alexzas business are described in
additional detail in the Companys Annual Report on Form 10-K for the year ended December 31, 2010,
and the Companys other Periodic and Current Reports filed with the Securities and Exchange
Commission including the risks under the headings: Regulatory authorities may not approve our
product candidates even if they meet safety and efficacy endpoints in clinical trials., We have a
history of net losses. We expect to continue to incur substantial and increasing net losses for the
foreseeable future, and we may never achieve or maintain profitability., and We will need
substantial additional capital in the future. If additional capital is not available, we will have
to delay, reduce or cease operations. 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.
CONTACT: | Derek K. Cole Head, Investor Relations and Corporate Communications 650.944.7373 dcole@alexza.com |
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ALEXZA PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
(a development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three Months Ended | ||||||||
March 31, | ||||||||
2011 | 2010 | |||||||
Revenue |
$ | 1,259 | $ | | ||||
Operating expenses: |
||||||||
Research and development |
6,262 | 7,564 | ||||||
General and administrative |
2,820 | 5,052 | ||||||
Total operating expenses |
9,082 | 12,616 | ||||||
Income (loss) from operations |
(7,823 | ) | (12,616 | ) | ||||
Gain (loss) on change in fair value of
contingent consideration liability |
| (722 | ) | |||||
Interest and other income/ (expense), net |
10 | (19 | ) | |||||
Interest expense |
(602 | ) | (55 | ) | ||||
Net income (loss) |
(8,415 | ) | (13,412 | ) | ||||
Basic and diluted net loss per share |
$ | (0.14 | ) | $ | (0.26 | ) | ||
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ALEXZA PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
(a development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
March 31, | December 31, | |||||||
2011 | 2010(1) | |||||||
Assets |
||||||||
Cash, cash equivalents and marketable securities |
$ | 31,840 | $ | 41,449 | ||||
Other current assets |
670 | 965 | ||||||
Total current assets |
32,510 | 42,414 | ||||||
Property and equipment, net |
23,248 | 24,361 | ||||||
Other non-current assets |
465 | 1,707 | ||||||
Total assets |
$ | 56,223 | $ | 68,482 | ||||
Liabilities and stockholders equity (deficit) |
||||||||
Current liabilities |
$ | 30,644 | $ | 34,383 | ||||
Non-current liabilities |
21,239 | 21,809 | ||||||
Stockholders equity (deficit) |
4,340 | 12,290 | ||||||
Total liabilities and stockholders equity (deficit) |
$ | 56,223 | $ | 68,482 | ||||
(1) | Derived from audited consolidated financial statements at that date. |
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