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): February 24, 2016 (February 23, 2016)

 

 

ALEXZA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-51820   77-0567768
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   Identification No.)

 

Alexza Pharmaceuticals, Inc.

2091 Stierlin Court

Mountain View, California

   94043
(Address of principal executive offices)   (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):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ 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 February 23, 2016, Alexza Pharmaceuticals, Inc., or the Company, and Teva Pharmaceuticals USA, Inc., or Teva, entered into (i) Amendment No. 2, or the Second Amendment, to License and Supply Agreement dated May 7, 2013, as amended, or the License Agreement; (ii) an Amended and Restated Convertible Promissory Note that amends and restates the Convertible Promissory Note dated May 7, 2013, as amended, or the Amended Note; (iii) a Stock Issuance Agreement, or the Stock Issuance Agreement; and (iv) an Amended and Restated Registration Rights Agreement, or the Rights Agreement, that amends and restates the Registration Rights Agreement dated January 6, 2014. The Second Amendment completes the previously announced reacquisition of ADASUVE in the collaboration with Teva as described in the Current Report on Form 8-K filed on October 30, 2015.

The Second Amendment provides for (i) the transfer of the New Drug Application, or NDA, and related regulatory filings for ADASUVE to the Company and the assumption of responsibility by the Company for all regulatory activities related to ADASUVE in the United States as soon as practicable; (ii) an exclusive license of Teva intellectual property with respect to ADASUVE, which intellectual property will be assigned to the Company in connection with a change of control of the Company or an exclusive license to ADASUVE in the United States from the Company to a third party; (iii) the Company undertaking responsibility for the ADASUVE United States Phase 4 study, product pharmacovigilance, medical services, and REMS compliance, either through Teva’s vendors or vendors otherwise selected by the Company; (iv) the transfer to the Company from Teva of existing supplies of ADASUVE as well as all commercial, medical and academic materials, documents and relationships; (v) the right of the Company to sell Teva-labeled product in accordance with all applicable laws and Teva policies; (vi) the satisfaction and termination of all payment obligations of the parties with respect to the commercialization of ADASUVE except as described below with respect to the Amended Note and the Company’s issuance of shares of its common stock to Teva; and (vii) a mutual release between the parties with respect to claims under the License Agreement.

The Amended Note provides that (i) the Company shall issue of 2,172,886 shares of its common stock, or the Shares, to Teva pursuant to the Stock Issuance Agreement as consideration for a reduction in the outstanding balance of the Amended Note by $5,000,000 and forgiveness of all accrued and unpaid interest under the Amended Note; (ii) the Company shall repay the remaining $20,000,000 outstanding balance of the Amended Note in four annual consecutive payments of $5,000,000 beginning in the first calendar year following the calendar year in which the aggregate annual net sales of ADASUVE and any other Staccato-enabled products first reach $50,000,000 in the United States; and (iii) allows for prepayment by the Company of the outstanding balance of the Amended Note. The Company has agreed to provide certain registration rights under the Securities Act of 1933, as amended, or the Securities Act, with respect to the Shares pursuant to the Rights Agreement.

The Company intends to submit a FOIA Confidential Treatment Request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting that it be permitted to redact certain portions of the Second Amendment. The omitted material will be included in the request for confidential treatment.

On February 24, 2016, the Company issued a press release describing the Second Amendment and the Amended Note. 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

 

Item 3.02 Unregistered Sales of Equity Securities

The information provided under Item 1.01 is incorporated into this Item 3.02 by reference.

The Shares were issued to Teva on February 23, 2016 in accordance with the terms of the Amended Note and the related Stock Issuance Agreement dated February 23, 2016, or the Stock Issuance Agreement, as partial consideration for a reduction in the outstanding balance of the Amended Note by $5,000,000 and forgiveness of all accrued and unpaid interest under the Amended Note.

The Stock Issuance Agreement contains 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 Issuance 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 issued to Teva pursuant to the Stock Issuance Agreement were not registered at the time of issuance under the Securities Act and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements, but the Company has agreed to provide certain registration rights under the Securities Act with respect to the Shares pursuant to the Rights Agreement.

The Company issued the Shares in reliance on the exemption from registration provided for under Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder. The Company relied on the exemption from registration based in part on the representations made by Teva, including the representations with respect to Teva’s status as an accredited investor, as such term is defined in Rule 501(a) of the Securities Act, and Teva’s investment intent with respect to the Shares, and appropriate legends will be affixed to the certificates representing the 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.

Section 9 – Financial Statements and Exhibits

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
Number

   

Description

99.1    Press Release entitled “Alexza Pharmaceuticals Reacquires U.S. Commercial Rights for ADASUVE® (loxapine) inhalation powder” dated February 24, 2016.

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.

 

    ALEXZA PHARMACEUTICALS, INC.
Date: February 24, 2016     
  By:   

/s/ Thomas B. King

    

Thomas B. King

President and Chief Executive Officer

INDEX TO EXHIBITS

 

Exhibit
Number

   

Description

99.1    Press Release entitled “Alexza Pharmaceuticals Reacquires U.S. Commercial Rights for ADASUVE® (loxapine) inhalation powder” dated February 24, 2016.


Exhibit 99.1

 

LOGO

NEWS RELEASE - for immediate release

Alexza Pharmaceuticals Reacquires U.S. Commercial Rights

for ADASUVE® (loxapine) inhalation powder

Mountain View, California, February 24, 2016 - Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has reacquired U.S. commercial rights for ADASUVE® (loxapine) inhalation powder from Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd. Alexza and Teva have also restructured the obligations under the outstanding note from Teva. In conjunction with the reacquisition of U.S. ADASUVE rights, Alexza and Teva have completed a transition agreement, which is intended to provide continued availability of ADASUVE by Alexza to patients and health care providers.

Terms of the ADASUVE Product Reacquisition

 

  •   The ADASUVE NDA and related regulatory filings will be transferred to Alexza. Alexza will assume responsibility for all regulatory activities related to ADASUVE in the U.S.

 

  •   Responsibility for the ADASUVE U.S. Phase 4 study, product pharmacovigilance, medical services, and REMS compliance will be transferred to Alexza over the course of the next 90 days. Alexza intends to continue these activities with the relationships and agreements established by Teva.

 

  •   Teva will transfer to Alexza product inventory, promotional materials, and other ADASUVE trade materials. Alexza will have the ability to promote and distribute ADASUVE, under the currently approved label and labeling for up to 12 months, including to existing customers, subject to certain limitations.

 

  •   Alexza will take over responsibility for administering the ongoing investigator sponsored studies and the directed research grant.

Terms of the Teva Note Restructuring

 

  •   Alexza will issue approximately 2.17 million shares to Teva as consideration for the reduction in the Teva note by $5 million of principal and forgiveness of all accrued and unpaid interest. After the share issuance, Teva will own approximately 9.9% of Alexza’s outstanding common stock.

 

  •   The remaining Teva note balance will become payable in the first calendar year following the calendar year in which the aggregate annual net sales of ADASUVE and any other Staccato-based products first reach $50 million in the U.S. After the U.S. sales reach this threshold, the $20 million note balance will be due and will be payable in four consecutive annual payments of $5 million each.

 

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“We appreciate the efforts that Teva has made to date and are looking forward to continuing to build the ADASUVE brand. We remain confident in ADASUVE’s long-term commercial prospects and plan to continue to work with Teva to effect a smooth transition,” said Thomas B. King, Alexza President and CEO. “Moving forward, Alexza will have primary responsibility for the immediate commercial aspects of ADASUVE and is working diligently to identify a new U.S. commercial partner for ADASUVE.”

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. The product is approved for sale by the U.S. Food and Drug Administration, the European Commission and in several Latin American countries. 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

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 adequacy of the Company’s capital to support the Company’s operations, 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, 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

 

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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:    Thomas B. King
   President and CEO
   650.944.7900 (investor / media questions)
   investor.info@alexza.com

 

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