UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 27, 2014 (October 24, 2014)
ALEXZA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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| Delaware |
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000-51820 |
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77-0567768 |
| (State or other jurisdiction |
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(Commission |
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(IRS Employer |
| of incorporation) |
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File Number) |
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Identification No.) |
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| Alexza Pharmaceuticals, Inc.
2091 Stierlin Court
Mountain View, California |
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94043 |
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(Zip Code) |
Registrant’s telephone number, including area code: (650) 944-7000
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Section 1 – Registrant’s Business and Operations
| Item 1.01. |
Entry into a Material Definitive Agreement. |
On October 24, 2014, Alexza
Pharmaceuticals, Inc. (“Alexza”) and Grupo Ferrer Internacional, S.A. (“Ferrer”) entered into the Third Amendment (the “Amendment”) to the Collaboration, License and Supply Agreement (the “Agreement”) dated as
of October 5, 2011, as amended March 5, 2012 and November 26, 2013. Pursuant to the Amendment, Ferrer and Alexza have agreed to eliminate certain future potential milestone payments under the Agreement effective upon the purchase of
2,000,000 shares of Alexza’s common stock by Ferrer in a private placement at a purchase price of $4.00 per share. The purchase of the common stock by Ferrer will be subject to customary closing conditions and is expected to occur not later
than October 31, 2014 pursuant to a stock purchase agreement (the “Stock Purchase Agreement”).
The foregoing summary does
not purport to be complete and is qualified in its entirety by reference to the Amendment and the form of the Stock Purchase Agreement, which will be filed as an exhibit to a future periodic report of Alexza.
On October 27, 2014, Alexza issued a press release describing the Amendment. A copy of the press release is attached as Exhibit 99.1 to
this Current Report on Form 8-K.
Section 3 – Securities and Trading Markets
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Unregistered Sales of Equity Securities. |
The information provided above under
Item 1.01 is incorporated into this Item 3.02 by reference.
Upon the closing of the sale of common stock to Ferrer contemplated
by the Stock Purchase Agreement, Alexza will receive gross proceeds of approximately $8,000,000.
The Stock Purchase Agreement will
contain representations and warranties that each party will make to, and solely for the benefit of, the other in the context of all of the terms and conditions of that agreement and in the context of the specific relationship between the parties.
The provisions of the Stock Purchase Agreement, including the representations and warranties contained therein, will not be for the benefit of any party other than the parties to such agreement, and will not be intended as a document for investors
and the public to obtain factual information about the current state of affairs of the parties to such agreement.
The shares of common
stock to be issued to Ferrer pursuant to the Stock Purchase Agreement will not be registered at the time of issuance under the Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States
absent registration or an applicable exemption from registration requirements. Alexza will issue such shares in reliance on the exemption from registration provided for under Section 4(2) of the Securities Act and Regulation D or Regulation S
promulgated thereunder. Alexza will rely on the exemption from registration based in part on the representations made by Ferrer, including the representations with respect to Ferrer’s status as an accredited investor, as such term is defined in
Rule 501(a) of the Securities Act, and Ferrer’s investment intent with respect to such shares, and appropriate legends will be affixed to the certificates representing such shares. This Current Report on Form 8-K shall not constitute an offer
to sell or a solicitation of an offer to buy, nor shall there be any sale of, the securities described herein in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under
the securities laws of any such state or other jurisdiction.
Forward-Looking Statements
Statements in this Current Report on Form 8-K that are not strictly historical in nature constitute “forward-looking statements.”
Such statements include, but are not limited to, Alexza’s issuance of securities, the amount of proceeds from the sale of securities and the closing of such sale. Such forward-looking statements involve known and unknown risks, uncertainties
and other factors, that may cause actual results to be materially different from any results expressed or implied by such forward-looking statements. For example, there are risks associated with Ferrer fulfilling its obligation to purchase
securities pursuant to the Stock Purchase Agreement, Alexza’s ability to satisfy its conditions to close the sale of such securities and Alexza having adequate authorized shares available to sell to Ferrer subsequent to closing of the
transactions contemplated by the Stock Purchase Agreement. All forward-looking statements are qualified in their entirety by this cautionary statement. Alexza is providing this information as of this date and does not undertake any obligation to
update any forward-looking statements contained in this report as a result of new information, future events or otherwise.
Section 9 - Financial Statements and Exhibits
| Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
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| Exhibit Number |
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Description |
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| 99.1 |
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Press Release entitled “Alexza and Ferrer Expand ADASUVE® Partnership” dated October 27, 2014. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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ALEXZA PHARMACEUTICALS, INC. |
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| Date: October 27, 2014 |
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By: |
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/s/ Thomas B. King |
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Thomas B. King President and Chief Executive
Officer |
INDEX TO EXHIBITS
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| Exhibit Number |
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Description |
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| 99.1 |
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Press Release entitled “Alexza and Ferrer Expand ADASUVE® Partnership” dated October 27, 2014. |
Exhibit 99.1
NEWS RELEASE - for immediate release
Alexza and Ferrer Expand ADASUVE® Partnership
Ferrer Purchases $8 Million of Alexza Common Stock through
New Investment and Elimination of Potential Milestone Payments
Mountain View, California and Barcelona, Spain - October 27, 2014 - Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional,
S.A. (Ferrer) announced today that they have amended their agreement for ADASUVE® (Staccato® loxapine). Ferrer is Alexza’s
commercial partner for ADASUVE in the European Union, Latin America and the Commonwealth of Independent States countries (the Ferrer Territory). Ferrer and Alexza have agreed that Ferrer will purchase 2 million shares of Alexza common stock for
$4.00 per share, thereby becoming the Company’s largest shareholder. The purchase represents a combination of new investment and consideration for the elimination of certain future potential milestone payments under the agreement.
“Ferrer and Alexza’s collaboration has been focused on building the market for ADASUVE in our territory and a lasting relationship between the
companies,” said Jordi Ramentol, Chief Executive Officer of Ferrer. “The expansion of our relationship with Alexza with this strategic investment demonstrates our belief in ADASUVE as a highly valuable therapy, something we also hear from
physicians and patients who have had experience with this product. We are pleased to continue our work together to build ADASUVE into a global brand.”
“We have been very pleased with Ferrer’s commitment and progress in bringing ADASUVE to patients since the first country launch in Germany in the
summer of 2013. In addition to ADASUVE now being available in nine EU countries, Ferrer has secured three ADASUVE approvals in Latin America,” said Thomas B. King, Alexza’s President and CEO. “We continue to see momentum in the uptake
of ADASUVE and consistently hear from physicians about the clinical benefits that ADASUVE can convey to the patients they treat.”
King concluded,
“We are excited Ferrer is making this strategic investment in Alexza, which reinforces Ferrer’s commitment to ADASUVE as an important new therapeutic and to the long-standing collaboration between our two companies.”
About ADASUVE (Staccato loxapine)
ADASUVE is the first
and only inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. The EU marketing authorization for ADASUVE requires that patients receive regular treatment immediately after
administration of the product to control acute agitation symptoms. It also requires that ADASUVE be administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should
be available for treatment of possible severe respiratory side effects, such as bronchospasm. Alexza and Ferrer estimate that as many as 8 million adults in the EU suffer from schizophrenia or bipolar disorder1. Agitation is a common symptom for these patients2, characterized by feelings of distress, anxiety and loss of control.
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ADASUVE combines Alexza’s proprietary Staccato system with loxapine, an antipsychotic medicinal
product. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in intravenous-like pharmacokinetics and rapid systemic effects.
The authorization for ADASUVE in the EU differs from that in the United States, with respect to the indication statement, dose regimen, available dose
strengths, and risk mitigation and management plans. For more information about ADASUVE, including the Summary of Product Characteristics and Patient Information Leaflet approved in the EU, please visit the EMA website. For the full
prescribing information including boxed warnings for the U.S., please visit www.adasuve.com.
About Ferrer
Founded in 1959, Ferrer is a privately-held European R&D-based pharmaceutical company headquartered in Barcelona. It is active in the pharmaceutical,
health, fine chemicals and food sectors in Europe, Latin America, Africa, the Middle East, Asia and the United States. In total, Ferrer’s human healthcare products are commercialized in more than 90 countries, through 27 international
affiliates (including joint ventures) and 70 partners and distributors.
Ferrer carries out activities throughout the full pharmaceutical value chain,
from R&D to international marketing, including fine chemical development and the manufacturing of both raw materials and finished pharmaceuticals. Its research centers in Spain and Germany, and manufacturing sites in Europe and Latin
America cover the pharmaceutical, diagnostics, vaccine, fine chemical, food and feed sectors. For more information, visit www.ferrer.com.
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 is Alexza’s first commercial product, is based on the Staccato technology, and has been approved for
sale by the U.S. Food and Drug Administration, the European Commission, and in Chile, Costa Rica and Guatemala.
Teva Pharmaceuticals USA, Inc., a
subsidiary of Teva Pharmaceutical Industries Ltd., is Alexza’s commercial partner for ADASUVE in the U.S. Ferrer is Alexza’s commercial partner for ADASUVE in Europe, Latin America and the Commonwealth of Independent States countries.
For more information, visit www.alexza.com.
ADASUVE® and Staccato® are registered trademarks of Alexza Pharmaceuticals, Inc.
Safe Harbor Statement
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
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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.
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| CONTACT: |
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Ana Kapor Senior Director, Investor Relations
and Corporate Communications 650.944.7906
akapor@alexza.com |
References:
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Wittchen H.U., et al., 2011. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur. Neuropsychopharmacol. 21, 655-679. |
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Alexza data on file (primary market research among caregivers of patients with schizophrenia (95% have agitation) and bipolar patients (87% have agitation). |
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