UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form SD
SPECIALIZED DISCLOSURE REPORT
Alexza
Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
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| DELAWARE |
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000-51820 |
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77-0567768 |
| (State or Other Jurisdiction of
Incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification Number) |
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| 2091 Stierlin Court
Mountain View, CA |
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94043 |
| (Address of Principal Executive Offices) |
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(Zip Code) |
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| Mark K. Oki (650)944-7000 |
| (Name and telephone number, including area code, of the person to contact in connection with this report.) |
Check the appropriate box to indicate the rule pursuant to which this form is being filed, and provide the period to which the information in this form
applies:
| x |
Rule 13p-1 under the Securities Exchange Act (17 CFR 240.13p-1) for the reporting period from January 1 to December 31, 2014. |
Section 1—Conflict Minerals Disclosure
| Item 1.01 |
Conflict Minerals Disclosure and Report |
| a) |
Conflict Minerals in Products. |
Conflict minerals, as defined by paragraph (d)(3) of this item,
are necessary to the functionality or productions of a product manufactured by Alexza Pharmaceuticals, Inc. (referred to as “we”, “us”, or the “Company”) or contracted by the Company to be manufactured (the
“Company’s Products”) as defined in Rule 13p-1 under the Securities Exchange Act of 1934, as amended (the “Rule”) and for which manufacturing was completed in the period from January 1, 2014 to December 31, 2014.
Accordingly, we are filing this Form SD for the calendar year covered by this report, as required by the Rule.
| b) |
Implementation and Results of our Reasonable Country of Origin Inquiry. |
We evaluated our current
product lines and determined that certain product we manufacture or contract to manufacture contain tin, tungsten, tantalum and/or gold (3TG). We requested our manufacturers to complete a Reasonable County of Origin (“RCOI”) questionnaire
for each such conflict mineral. The survey of our suppliers determined that our supply chain is Conflict Free Undeterminable and as a result we have filed a Conflict Minerals Report.
We recognize that the supply chain tracing of these materials is complex; however, we are committed to working with our suppliers to determine whether the
products we manufacture or contract to manufacture are “conflict free,” that is, that they either do not contain conflict minerals from the Covered Countries or originate from recycled or scrap materials.
A copy of The Company’s Conflict Minerals Report is provided as Exhibit 1.01 hereto and is publicly available at: www.alexza.com under “Corporate
Governance”.
The Conflict Minerals Report required by Item 1.01 is filed as Exhibit 1.01 to this Form SD.
Section 2—Exhibits
Exhibit 1.01—Conflict Minerals Report for Alexza Pharmaceuticals, Inc.
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 duly
authorized undersigned.
Alexza Pharmaceuticals, Inc.
(Registrant)
/s/ Mark K. Oki
Senior Vice President, Finance, Chief Financial Officer and Secretary
May 27, 2015
Exhibit 1.01
Alexza Pharmaceuticals, Inc.
Conflict Minerals Report
For The Year Ended December 31, 2014
This report for the year ended December 31, 2014 is presented to comply with Rule 13p-1 under the Securities Exchange Act of 1934 (the Rule). For the
purpose of the required Reasonable Country of Origin Inquiry (RCOI), Alexza continues to review its supply chain. The Rule was adopted by the Securities and Exchange Commission (SEC) to implement reporting and disclosure requirements related to
conflict minerals as directed by the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (Dodd-Frank Act). The Rule imposes certain reporting obligations on SEC registrants whose manufactured products contain conflict minerals which
are necessary to the functionality or production of their products. Conflict Minerals are defined as cassiterite, columbite-tantalite, gold, wolframite, and their derivatives, which are limited to tin, tantalum, tungsten, and gold (3TG) for the
purposes of this assessment. These requirements apply to registrants whatever the geographic origin of the conflict minerals and whether or not they fund armed conflict.
If a registrant can establish that the conflict minerals originated from sources other than the Democratic Republic of the Congo or an adjoining country (the
Covered Countries), or from recycled and scrap sources, they must submit a Form SD which describes the Reasonable Country of Origin Inquiry completed.
If
a registrant has reason to believe that any of the conflict minerals in their supply chain may have originated in the Covered Countries, or if they are unable to determine the country of origin of those conflict minerals, then the issuer must
exercise due diligence on the conflict minerals’ source and chain of custody. The registrant must annually submit a Conflict Minerals Report (CMR) to the SEC that includes a description of those due diligence measures.
The report presented herein is not audited as the Rule provides that if a registrant’s products are “DRC conflict undeterminable” in 2013 or
2014, the CMR is not subject to an independent private sector audit.
1. Company Overview
This report has been prepared by management of Alexza Pharmaceuticals, Inc. (herein referred to as “Alexza” the “Company,” “we,”
“us,” or “our”). The information includes the activities of all majority-owned subsidiaries.
We are a pharmaceutical company focused
on the research, development and commercialization of novel proprietary products for the acute treatment of central nervous system conditions. We have over 80 employees located in our principal executive offices. We were incorporated in the state of
Delaware on December 19, 2000 as FaxMed, Inc., changed our name to Alexza Corporation in June 2001 and in December 2001 became Alexza Molecular Delivery Corporation. In July 2005, we changed our name to Alexza Pharmaceuticals, Inc. Our
principal executive offices are located at 2091 Stierlin Court, Mountain View, CA 94043.
2. Products Overview
The Staccato® system, our proprietary technology, is the foundation for our first approved product,
ADASUVE® (Staccato loxapine), and all of our product candidates. The Staccato system vaporizes excipient-free drugs to form a condensation aerosol that, when inhaled, allows for
rapid systemic drug delivery. Because of the particle size of the aerosol, the drug is quickly absorbed through the deep lung into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous, or IV, administration but
with greater ease, patient comfort and convenience.
For purposes of this report, our Staccato device, which is the basis for ADASUVE and all of our product
candidates, was assessed because we believe this device is our only product to contain 3TG materials. Based on our review of our supply chain, as described in more detail below, we believe that the countries of origin for the 3TG materials contained
in our Staccato device included the United States and Canada.
3. Supply Chain Overview
In order to manage the scope of this task, we rely upon our suppliers to provide information on the origin of the 3TG contained in components and materials
supplied to us, including sources of 3TG that are supplied to them from sub-tier suppliers. Our suppliers responded to our inquiry on the 3TG sourcing information and one made a 2013 report available on their company website.
We made inquiries to our suppliers regarding the inclusion of conflict minerals in parts supplied to us in compliance with emerging SEC requirements. Our due
diligence processes have been developed in conjunction with the 2nd edition of The Organization for Economic Cooperation and Development (OECD) Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk
Areas (OECD Guidance).
We defined the scope of our conflict minerals due diligence by identifying and reaching out to our current suppliers of our
Staccato device. We adopted the Supplier Conflict Materials Certification form based on the Conflict Minerals reporting templates established by the Conflict-Free Sourcing Initiative (CFSI), and launched our conflict minerals due diligence
communication survey to our commercial manufacturing suppliers in 2014. We look to industry guidelines to help establish our programs such as the joint Electronic Industry Citizen Coalition (EICC) and the Global e-Sustainability Initiative (GeSI)
which is taking action to address responsible sourcing through the development of the Conflict-Free Smelter (CFS) program aiming to enable companies to source conflict-free minerals.
4. Reasonable Country of Origin Inquiry (RCOI) and RCOI conclusion:
We conducted an analysis of our products and found that the 3TG materials can be found in our Staccato device. Therefore, the Staccato based products that we
manufacture are subject to the reporting obligations of Rule 13p-1.
During calendar year 2014, we shipped approximately 95,000 Staccato devices, which
contained, in the aggregate approximately 950 grams of gold (over 2 pounds), 0.050 grams of tungsten (less than 1/500th of an ounce), and 7.56 kilograms of tantalum (nearly 17 pounds).
Despite having conducted a good faith reasonable country of origin inquiry, we have concluded that our supply chain remains “DRC conflict
undeterminable”. The majority of our suppliers investigated, obtained information from their suppliers, and reported that the materials used in the manufacturing of our Staccato devices did not contain conflict metals that originated from the
covered countries. However, after reviewing the compliance information available from one of our suppliers’ website, the supplier reported that they did not have sufficient information to determine the country of origin of some of the 3TG
minerals used in our Staccato device.
Due to the lack of substantive response from a supplier, it will take time for such supplier to verify the
origin of all of the minerals. Using our supply chain due diligence processes, driving accountability within the supply chain by leveraging our program based on the CFSI/CFS program, and continuing our outreach efforts we hope to develop additional
transparency into our supply chain.
5. Conflict Minerals Status Analysis and Conflict Status conclusion:
We have concluded that our supply chain remains “DRC conflict undeterminable”. We have reached this conclusion because we have been unable to
determine the origin of all of the 3TG materials used in our instruments and arrays.
6. Risk Mitigation-Improvement Program
The steps that we plan to take in reporting year 2015 to mitigate the risk that the Staccato device benefits or finances armed groups are as follows:
a. We will continue to work with the supplier who provided incomplete or insufficient information in an effort to obtain compete and
accurate information in 2015;
b. We will again request information and supporting data from each supplier providing parts to us that are
subject to 2015 reporting requirements by utilizing the Supplier Conflict Materials Certification form based on the Conflict Minerals reporting templates established by the CFSI; and will pursue a completed template response.
c. We will follow our due diligence process to review and validate supplier responses that are obtained in support of our 2015 conflict
minerals reporting.
7. Additional Risk Factors
The
statements above are based on the RCOI process and due diligence performed in good faith by us. These statements are based on the infrastructure and information available at the time. A number of factors could introduce errors or otherwise affect
our conflict materials determinations. These factors include, but are not limited to, gaps in product or product content information, gaps in supplier data, gaps in smelter data, errors or omissions by or of suppliers, errors or omissions by
smelters, the definition of a smelter was not finalized at the end of the 2014 reporting period, confusion over requirements of SEC final rules, gaps in supplier education and knowledge, lack of timeliness of data, public information not discovered
during a reasonable search, errors in public data, language barriers and translation, supplier and smelter unfamiliarity with the protocol due to this being the first year for SEC disclosures for Section 1502 of Dodd-Frank, oversights or errors
in conflict free smelter audits, Conflict Area sourced materials being declared secondary materials, companies going out of business in 2014, certification programs that are not equally advanced for all industry segments and metals, and smuggling of
Conflict Area Conflict Minerals to countries beyond the covered countries.