UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): September 15, 2016
ACUCELA INC.
(Exact name of registrant as specified in its charter)
| Washington | 000-55133 | 02-0592619 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
1301 Second Avenue, Suite 4200
Seattle, Washington 98101
(Address of principal executive offices, including zip code)
(206) 805-8300
(Registrant’s telephone number, including area code)
(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):
| x | 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)) |
| Item 8.01 | Other Events. |
On September 15, 2016, Acucela Inc. (the “Company”) commenced the mailing of materials for its 2016 annual meeting of shareholders, which materials included a letter to the Company’s shareholders from Dr. Ryo Kubota, the Company’s President and Chief Executive Officer. The letter to shareholders relates in part to the proposed merger of the Company with and into an indirect, wholly-owned subsidiary of the Company for the purposes of redomiciling the Company’s corporate headquarters to Japan (the “Redomicile Transaction”). A copy of that letter is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number | Description | |
| 99.1 | Letter from Acucela Inc. President and Chief Executive Officer to Company shareholders. | |
Cautionary Statement Regarding Forward Looking Statements
This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, including with respect to the ability of the Company to consummate the Redomicile Transaction; the Company’s strategic plan and execution thereof; expectations regarding corporate development activities and the ultimate success of the enterprise; the Company’s development plans and ability to successfully commercialize its product candidates; the timing of and results from the Company’s and its collaborators’ ongoing clinical trials and pre-clinical development activities; the potential efficacy, future development plans and commercial potential of the Company’s and its collaborators’ product candidates, the progress and potential of ongoing development programs and the Company’s anticipated financial and operating results. Such forward-looking statements typically can be identified by the use of words such as “expect,” “estimate,” “anticipate,” “forecast,” “intend,” “project,” “target,” “plan,” “believe” and similar terms and expressions. Forward-looking statements are based on current expectations and assumptions. Although the Company believes that its expectations and assumptions are reasonable, it can give no assurance that these expectations and assumptions will prove to have been correct, and actual results may vary materially. For example, (1) the Company may have to postpone the annual meeting of shareholders, (2) the Company may be unable to obtain the shareholder approval required for the Redomicile Transaction; (3) the Company may abandon the Redomicile Transaction; (4) conditions to the closing of the Redomicile Transaction may not be satisfied; (5) problems may arise in connection with the relocation of the Company’s headquarters to Japan, which may result in less effective or efficient operations; (6) the Redomicile Transaction may involve unexpected costs, unexpected liabilities or unexpected delays; (7) the Company’s business may suffer as a result of uncertainty surrounding the Redomicile Transaction; (8) the Company may not realize the anticipated benefits of the Redomicile Transaction; (9) the Redomicile Transaction may negatively impact the Company’s relationships, including with employees, suppliers, collaborators, competitors and investors; (10) the Redomicile Transaction may result in negative publicity affecting the Company’s business and the price of the Company’s common stock; (11) the Redomicile Transaction may have negative tax consequences to the Company and holders of the Company’s common stock; (12) the Company may be adversely affected by other economic, business, and/or competitive factors; (13) the Company’s investigational product candidates may not demonstrate the expected safety and efficacy; (14) the Company’s pre-clinical development efforts may not yield additional product candidates; (15) any of the Company’s or its collaborators’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; and (16) new developments in the intensely competitive ophthalmic pharmaceutical market may require changes in the Company’s clinical trial plans or limit the potential benefits of its investigational product candidates, as well as the other risks identified in the Company’s filings with the Securities and Exchange Commission. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the business of the Company described in the “Risk Factors” section of its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed by the Company from time to time with the SEC, as well as the risks and uncertainties described in the “Risk Factors” section
of the Registration Statement on Form S-4 (File No. 333-210469) (the “Form S-4”) filed by Acucela Japan KK with the SEC on March 30, 2016, as amended on August 12, 2016, in connection with the Redomicile Transaction, which Form S-4 was declared effective by the SEC on August 17, 2016. All forward-looking statements included in this document are based upon information available to the Company on the date hereof, and the Company does not assume any obligation to update or revise any such forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance or events and circumstances reflected in those statements will be achieved or will occur, and actual results could differ materially from those anticipated or implied in the forward-looking statements. Except as required by law, we do not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. You should read the documents we have filed with the SEC for more complete information about the Company. These documents are available on both the EDGAR section of the SEC’s website at www.sec.gov and the Investor Relations section of the Company’s website at ir.acucela.com.
Additional Information and Where to Find it
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The Redomicile Transaction will be submitted to the shareholders of the Company for their consideration. Acucela Japan KK filed the Form S-4 with the SEC on March 30, 2016, as amended on August 12, 2016, that includes a preliminary prospectus of Acucela Japan KK and a preliminary proxy statement of the Company, and each of Acucela Japan KK and the Company also plans to file other relevant documents with the SEC regarding the Redomicile Transaction. The Form S-4 was declared effective by the SEC on August 17, 2016 and, the definitive proxy statement/prospectus was first mailed to the shareholders of the Company on September 15, 2016. INVESTORS AND SECURITY HOLDERS OF ACUCELA INC. ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS (INCLUDING ALL AMENDMENTS AND SUPPLEMENTS THERETO) CAREFULLY AS WELL AS ANY OTHER RELEVANT DOCUMENTS THAT WILL BE FILED WITH THE SEC WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT ACUCELA JAPAN KK, ACUCELA INC. AND THE REDOMICILE TRANSACTION. Investors and security holders may obtain a free copy of the proxy statement/prospectus and other relevant documents (when available) filed and to be filed with the SEC from the SEC’s web site at www.sec.gov or at the Company’s web site at ir.acucela.com. Investors and security holders may also read and copy any reports, statements and other information filed by Acucela Inc. or Acucela Japan KK, with the SEC, at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 or visit the SEC’s website for further information on its public reference room. Investors and security holders may also obtain, without charge, a copy of the proxy statement/prospectus and other relevant documents (when available) by directing a request by mail or telephone to Investor Relations, Acucela Inc., 1301 Second Avenue, Suite 4200, Seattle, WA 98101, telephone (206) 805-8300.
Participants in the Merger Solicitation
Acucela Inc. and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the Company’s shareholders in connection with the proposed Redomicile Transaction. Information about these persons is set forth in the Company’s Annual Report on Form 10-K filed by the Company with the SEC on March 11, 2016, and is included in the Form S-4 and in any documents subsequently filed by its directors and officers under the Securities Exchange Act of 1934, as amended. These documents can be obtained free of charge from the sources indicated above. Investors and security holders may obtain additional information regarding the interests of such persons, which may be different from those of the Company’s shareholders generally, by reading the proxy statement/prospectus and other relevant documents regarding the proposed inversion to be filed with the SEC when they become available.
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SIGNATURE
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.
ACUCELA INC.
Date: September 15, 2016
| By: | /s/ John E. Gebhart | |
| John E. Gebhart | ||
| Chief Financial Officer |
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EXHIBIT INDEX
| Exhibit Number | Description | |
| 99.1 | Letter from Acucela Inc. President and Chief Executive Officer to Company shareholders. | |
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Exhibit 99.1
Dear Shareholders,
Since Acucela was founded, the goal of the company was to develop therapeutics to treat sight-threatening diseases. We are focused on developing oral therapeutics based on our proprietary visual cycle modulation technology, and our lead investigational drug candidate, emixustat hydrochloride, is being developed for serious retinal diseases. We are currently evaluating emixustat in an ongoing Phase 2 clinical trial in patients with diabetic retinopathy initiated in the second quarter of 2016, and we are planning to initiate a clinical trial evaluating emixustat in patients with Stargardt disease by early 2017. We are also developing a human rhodopsin-based gene therapy for patients suffering from retinitis pigmentosa with the aim to initiate a Phase 2 clinical study in 2018 and a lanosterol-based pharmaceutical treatment for cataracts and presbyopia with the aim to initiate a Phase 1/2 clinical study in patients with cataracts in late 2017 or early 2018. We are also evaluating opportunities to expand our ophthalmic product pipeline through internal research, M&A and additional partnering or in-licensing opportunities as we seek to build an ophthalmological medical solutions company offering innovative therapeutics and medical technologies to fight sight-threatening diseases.
Years ago, as a researcher and a clinical ophthalmologist, I met with and treated many patients suffering from sight-threatening diseases for which there was no cure. This experience led me to pursue the research and development of new therapeutics with the potential to address a large number of patients, not just the limited number I could personally care for in a clinical setting. I believed, and still believe, that the most meaningful innovations in medicine should shift from invasive surgeries to non-invasive therapies to treat and overcome diseases, and thereby decrease the burden of treatment for patients. Our vision is always to put the patients as the top priority.
Innovation requires out-of-the-box thinking, tenacity and hard work by well-trained, talented individuals. To foster innovation, an organization must access human resources with diverse professional and cultural backgrounds and perspectives and encourage open dialog. To find an existing pool of accomplished individuals, I looked to the United States to attract the best and brightest from all over the world.
With these thoughts, I founded Acucela in 2002, in Seattle, to identify and develop novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases affecting millions of people worldwide.
Acucela’s early investors and long-term supporters were concentrated in Japan, where interest in the company has remained strong. Based in part on this interest, Acucela completed an initial public offering in 2014 on the Mothers market of the Tokyo Stock Exchange, becoming the first U.S. based company to complete such a listing.
In March 2016, Acucela announced that, with shareholder approval, the company will conduct a triangular merger in order to relocate our head office functions to Japan. When this process is complete, Acucela Japan, which was established as a Japanese subsidiary of Acucela in December 2015, will become a holding company that controls Acucela as a subsidiary. One of our goals in pursuing this transaction is to bring the company closer to the investment community in Japan while maintaining our significant operational presence in Seattle.
By relocating the head office functions to Japan, we aim for increased availability, quantity and prominence of information about the company for interested investors in Japan and believe such increased access to information will enhance the understanding of our business and provide more effective communication with our Japanese investors. Also, institutional investors with a focus on TSE-listed companies, who by mandate or other internal fund restrictions have not been able to invest in non-Japanese domiciled companies, will have the opportunity to invest in us, which may in turn lead to an increase in analyst research coverage.
The last year has brought significant change to Acucela. We have strengthened our commitment to our goal of providing a broad range of solutions to combat sight-threatening disorders by expanding our research portfolio. New members of our leadership team bring strength and experience to the company. And we are now in the process of solidifying our ties in the nation where investor interest has remained the strongest. We believe that changes of this magnitude call for a reintroduction of the company and our identity. To this end, we have announced that upon the completion of the proposed triangular merger, Acucela Japan will be officially named Kubota Pharmaceutical Holdings Co., Ltd., and its subsidiary in Seattle will be Acucela Inc.
Unmet medical needs are prevalent in ophthalmology causing millions of patients to suffer from sight-threatening disorders. The future we envision for these patients is only attainable through the dedication of the talented scientists and professionals that have come together to create our company. We are committed to developing innovative therapeutics and medical technologies to help these patients, and we believe our accomplishments and continued efforts have now prepared us to reach for the next stage of growth for our company.
Thank you for supporting our vision of eradicating blindness from the world.
/s/ Ryo Kubota
Ryo Kubota, MD, PhD
Chairman, President and Chief Executive Officer
Acucela Inc.
Certain statements contained in this letter may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. A detailed discussion of such forward-looking statements and the related risks and uncertainties is included in our Annual Report on Form 10-K included herewith and is also available in other documents that we file with the U.S. Securities and Exchange Commission.