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Announcement on Proposed Conversion of Japanese Subsidiary into the Holding Company of Acucela Inc. through Triangular Merger, Application for Listing of Shares as a Domestic Company, and Partial Amendment to the Bylaws of Acucela Inc.

2016年03月29日 AM09:35
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SEATTLE

Acucela Inc. (located in Seattle, Washington, U.S.A.; the “Company”) (TOKYO:4589), a clinical stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases, has unanimously resolved at its board of directors meeting held on March 28, 2016 (Pacific Daylight Time) to (i) convert Acucela Japan Kabushiki Kaisha (the “Japan Holding Company”), which was established as a Japanese subsidiary of the Company in December 2015, into a holding company that controls Acucela North America Inc. (the “U.S. Subsidiary”), which will succeed to the business of the Company, in order to relocate the head office functions of the Company to Japan, by conducting a triangular merger (the “Triangular Merger”) whereby one share of common stock of the Japan Holding Company will be distributed in exchange for each share of common stock of the Company, and (ii) apply for listing of shares of common stock of the Japan Holding Company on the Tokyo Stock Exchange (the “TSE”).

The Triangular Merger will become effective on the conditions that it is approved by a majority of the outstanding shares of the Company’s common stock entitled to vote on the Triangular Merger at the Company’s annual meeting of shareholders, that the shares of common stock of the Japan Holding Company are approved for listing on the TSE, and that the other conditions provided in the merger agreement to be executed in order to complete the Triangular Merger (the “Merger Agreement”) are satisfied.

In addition, in order to obtain the requisite shareholder approval for the Triangular Merger at the 2016 annual meeting of shareholders, the Company’s board of directors resolved at its meeting held on March 28, 2016 (Pacific Daylight Time) to amend the Bylaws of the Company by deleting the provision requiring that the annual meeting of the shareholders be held on a date not more than 180 days after the end of the Company’s fiscal year.

I. Proposed Conversion of Japanese Subsidiary into the Holding Company of Acucela Inc. through Triangular Merger and Application for Listing of Shares as a Domestic Company

1. Background and Reasons for Conversion of Japanese Subsidiary into the Holding Company of Acucela Inc.

Acucela was founded in Seattle, WA in 2002, by Ryo Kubota, PhD, MD, an ophthalmologist, to develop therapies to treat sight-threatening diseases. In February 2014, the Company listed on the Mothers market of the TSE. Acucela’s emixustat hydrochloride (“Emixustat”) is currently in development for age-related macular degeneration (“AMD”)* and the Company is focused on developing oral products based on its proprietary visual cycle modulation (“VCM”) compounds to address a variety of retinal diseases, including AMD, diabetic retinopathy, Stargardt’s disease and potentially diabetic macular edema. The Company’s business strategy is to develop an innovative portfolio of ophthalmology products by (i) working with its collaborator, Otsuka Pharmaceutical Co., Ltd., on the development of Emixustat, (ii) leveraging its experience in VCM to pursue other potential applications for Emixustat and (iii) expanding its product pipeline through internal research, acquisitions and additional partnering and in-licensing opportunities. Following completion of the Triangular Merger, the Company intends to pursue additional business development opportunities and execute on its strategy to become a company offering multiple solutions to sight-threatening diseases.

The Company believes that the primary potential benefits of the Triangular Merger include:

  • increased availability, quantity and prominence of information about the Company for Japanese investors, which can be made available in the Kaisha Shikiho and Nikkei Kaisha Joho, two publications frequently used by Japanese investors to find information on listed companies in Japan. This increased access to information may enhance the understanding of our business and provide more effective communication to our Japanese investors;
  • as a Japanese entity, the Japan Holding Company will be eligible for future consideration to be included in the Mothers Index of the TSE;
  • 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 equities, will have the opportunity to invest; and
  • increased analyst research coverage, if investor demand for listed securities of the Japan Holding Company increases following the Triangular Merger.

Another potential benefit of the Triangular Merger is to provide the Company the opportunity to increase its visibility and business presence in Japan. A Japanese entity will potentially allow for opportunities in Japan such as conducting internal research and establishing partnerships for R&D and drug development through collaborations with Japanese pharmaceutical companies and academic institutions.

If the potential benefits are realized following the Triangular Merger, the Company believes that demand for listed securities of the Japan Holding Company may increase, thereby providing greater liquidity for its shareholders and enhanced shareholder value.

Following completion of the Triangular Merger, the common shares of the Company are expected to be delisted and the common shares of the Japanese Holding Company are expected to be listed for trading on the Mothers market of the TSE.

“Since day one of founding Acucela almost 14 years ago, Acucela has been committed to drug development, and we are now in the process of Acucela’s next stage of growth towards medical technologies to treat sight-threatening diseases,” stated Ryo Kubota, MD, PhD, chairman, president and CEO, Acucela Inc. “We will utilize the opportunities provided by the Triangular Merger to transfer our headquarters to Japan, and I, along with our team, are committed to expanding our business and to develop and deliver the very best therapies for sight-threatening eye diseases in Japan and the rest of the world.”

* Emixustat hydrochloride, is in development for the potential treatment of geographic atrophy (“GA”) associated with the dry form of AMD. The long-term clinical safety and efficacy of Emixustat is being evaluated in an ongoing Phase 2b/3 study. Top-line 24-month clinical trial results are expected by June 2016.

2. Outline of Conversion of Japanese Subsidiary into the Holding Company of Acucela Inc.

(1) Anticipated schedule for conversion of the Japanese subsidiary into the holding company

         
Resolution of the board of directors to pursue the Triangular Merger       March 28, 2016 (Monday) (Pacific Daylight Time)
Anticipated execution of the Merger Agreement       June 2016 (Pacific Daylight Time) (scheduled)
Anticipated date for the annual meeting of shareholders       August 2016 (scheduled)
Anticipated date of delisting (the Company)       Mid-September 2016 (scheduled)
Anticipated effective date of the Triangular Merger       Mid-September 2016 (scheduled)
Anticipated date of listing of the Japan Holding Company       Mid-September 2016 (scheduled)
     

* The above schedule may be changed depending on many factors, including the timing of effectiveness of the registration statement to be filed by the Japan Holding Company in the U.S. on Form S-4 (the “Registration Statement”) under the Securities Act of 1933, the status of examination by the TSE, and the preparation for practical matters necessary to be addressed prior to the distribution of shares of the Japan Holding Company. The anticipated dates noted above will be announced when determined.

(2) Anticipated method of converting the Japanese subsidiary into the holding company

(A) The U.S. Subsidiary, incorporated under the laws of the state of Washington, United States on March 24, 2016 (Pacific Daylight Time), is a wholly-owned subsidiary of the Japan Holding Company.

(B) The Company, Japan Holding Company and U.S. Subsidiary will enter into the Merger Agreement in order to complete the Triangular Merger. Pursuant to the terms of the Merger Agreement, at the effective time, the Company will merge into U.S. Subsidiary, with U.S. Subsidiary surviving the Triangular Merger as a wholly-owned subsidiary of Japan Holding Company. As consideration for the Triangular Merger, one share of common stock of the Japan Holding Company will be distributed to the shareholders of the Company in exchange for each share of common stock of the Company.

For the details of the method of converting the Japanese subsidiary into the holding company, please see the attachment to this announcement.

The Triangular Merger will become effective on the conditions that it is approved by a majority of the outstanding shares of the Company’s common stock entitled to vote on the Triangular Merger at the Company’s annual meeting of shareholders, that the shares of common stock of the Japan Holding Company are approved for listing on the TSE, and that the other conditions provided in the Merger Agreement are satisfied. If these and other applicable conditions are satisfied, when the Triangular Merger becomes effective, the shareholders of the Company will acquire shares of the Japan Holding Company to be listed on the TSE.

(Taxation of Japanese holders in relation to the Triangular Merger – for information purposes only)

Based on the current assumptions, the Triangular Merger should be treated as a qualified merger within the meaning of Item 12-8 of Section 2 of the Japanese Corporation Tax Act. Assuming this treatment is respected, Japanese holders of the Company will not recognize any capital gains/losses or deemed dividend, for Japanese tax purposes, upon the receipt of shares of common stock of the Japan Holding Company in exchange for shares of the Company’s common stock in connection with the Triangular Merger. This summary does not discuss all Japanese tax considerations that may be relevant to a particular the Company’s or the Japan Holding Company’s shareholder in light of his or her personal circumstances. Additional information regarding the tax implications of the Triangular Merger will be included in the registration statement that the Japan Holding Company intends to file with the U.S. Securities and Exchange Commission. Any material information will be disclosed in Japanese as necessary.

(3) Details of allotment in the Triangular Merger

(A) Allotment ratio in the Triangular Merger

                       
      Acucela Japan Kabushiki Kaisha       Acucela Inc.
(English name: Acucela Japan KK) (Wholly-owned subsidiary)
        (Wholly-owning parent company)        
Allotment ratio*       1       1
 

* Upon the Triangular Merger, one share of common stock of the Japan Holding Company will be distributed to the shareholders of the Company in exchange for each share of common stock of the Company.

(i) Estimated number of new shares to be distributed through the Triangular Merger

Anticipated to be 37,644,582 shares

The above number of shares is calculated based on the total number of outstanding shares (37,644,582 shares) of the Company as of March 3, 2016.

However, the number of shares to be actually distributed may be changed due to future exercise of stock options, vesting of the restricted stock units or otherwise.

(ii) Number of shares constituting one share unit

The Japan Holding Company will use the share unit system, and the number of shares constituting one share unit will be 100 shares.

(iii) Basis for calculation of allotment ratio

Given that the shareholder composition of the Japan Holding Company immediately after the Triangular Merger is intended to be identical with that of the Company immediately prior to the Triangular Merger, the Company determines to maintain the previous investment units, and allocate one share of common stock of the Japan Holding Company for each share of common stock of the Company held by its shareholders.

(iv) Results of calculation by a third-party appraiser, and method and basis thereof

For the reasons described in (iii) above, the Company has not engaged any third-party appraiser for the calculation of the allotment ratio.

(B) Overview of issuer (Japan Holding Company) of shares as consideration for the Triangular Merger (as of December 31, 2015)

               
(1) Trade Name       Acucela Japan Kabushiki Kaisha
        (English name: Acucela Japan KK)
(2) Address       Shibuya-ku, Tokyo
(3) Name and Title of Representative       Ryo Kubota, Representative Director, Chairman, President and Chief Executive Officer
(4) Nature of Principal Business       Research, development, export and import, and manufacturing, commissioned manufacturing and sales of medical products
(5) Capital Amount       500,000 yen
(6) Date of Establishment       December 11, 2015
(7) Total Number of Shares Issued       10 shares
(8) End of Fiscal Period       December 31

(9) Major Shareholders and Shareholding Ratio

      Company: 100%
(10) Net Assets       (607,087) yen
(11) Gross Assets       500,000 yen
 

* Prior to the effective date of the Triangular Merger, the Japan Holding Company will issue new shares to the Company to increase its capital and the total number of outstanding shares of the Japan Holding Company’s common stock. In addition, on the effective date of the Triangular Merger, the Japan Holding Company will effect a stock split at such ratio as to cause the total number of outstanding shares of the Japan Holding Company’s common stock to be equal to the total number of outstanding shares of the Company’s common stock as of the same effective date.

(C) Matters relating to the method of liquidation of consideration

(i) Market on which the consideration is traded

TSE Mothers market (planned)

(ii) Person(s) providing brokerage services for transactions

Financial instruments business operators (i.e., securities firms) throughout Japan will provide brokerage services for shares of common stock of the Japan Holding Company after the completion of the listing on the TSE.

(iii) Restriction(s) on assignment or other disposal to which the consideration is subject

Not applicable.

(iv) Third-party permit(s), etc., necessary for transfer or exercise of consideration

Not applicable.

(v) Matters relating to the market value of consideration

Currently not applicable; however, the shares of common stock of the Japan Holding Company will be listed on the TSE.

(vi) Matters relating to the method by which the consideration may be repurchased as treasury shares, redeemed or liquidated through other similar procedures, if applicable

Not applicable.

(4) Handling of stock options, restricted stock units and restricted stock in the Triangular Merger

It is contemplated at the effective time of the Triangular Merger, the outstanding stock options of the Company will be cancelled, and in exchange therefor, stock acquisition rights of the Japan Holding Company will be issued to the holders of the Company’s stock options. Such stock acquisition rights will have material terms that are substantially similar to the applicable stock options. It is also contemplated at the effective time of the Triangular Merger, the outstanding restricted stock units of the Company will be cancelled, and in exchange therefor, stock acquisition rights of the Japan Holding Company will be issued to the holders of the restricted stock units. Such stock acquisition rights will have an exercise price of one (1) yen per share and will have material terms that are substantially similar to the applicable restricted stock units. In addition, at the effective time of the Triangular Merger, similar to the other outstanding shares of the Company’s common stock, the outstanding shares of restricted stock of the Company will be cancelled, and in exchange therefor, shares of the Japan Holding Company will be distributed to the holders of the restricted stock. It is contemplated that the holders of the restricted stock will be subject to restrictions with respect to the shares of the Japan Holding Company common stock that are substantially similar in all material respects to the applicable restricted stock of the Company.

The Company has not issued any bonds with stock acquisition rights.

(5) Handling of the listing of the Japan Holding Company

The Japan Holding Company plans to apply for a new listing (technical listing) of shares of its common stock on the Mothers market of the TSE as a domestic company, and the listing is scheduled to occur in mid-September 2016. In addition, the Company will be merged into the U.S. Subsidiary as the dissolving company in the Triangular Merger, and therefore is expected to be delisted from the Mothers market of the TSE in mid-September 2016 prior to the listing of the Japan Holding Company.

The dates of the listing of the Japan Holding Company and the delisting of the Company may be changed depending on when the Registration Statement becomes effective, the status of examination by the TSE, and the preparation for practical matters necessary to be addressed prior to the distribution of shares of the Japan Holding Company.

3. Overview of Companies that are Parties to the Triangular Merger

(1) Company (as of December 31, 2015)

         
(1) Company Name       Acucela Inc.
(2) Address       Seattle, Washington, U.S.A.
(3) Name and Title of Representative       Ryo Kubota, Chairman, President and Chief Executive Officer
(4) Principal Business       A clinical stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases affecting millions of people worldwide.
(5) Capital Amount (thousand U.S. dollars)       166,434
(6) Date of Establishment       April 2002
(7) Total Number of Shares Issued       37,644,582 (as of March 3, 2016)
(8) Fiscal Year End       December 31
(9) Number of Employees       49
(10) Main Banks       Not applicable
(11) Major Shareholders and       Ryo Kubota, M.D., Ph.D. 28.1%
Shareholding Ratio SBI Capital( (1)) 5.6%
(as of December 31, 2015) Otsuka Pharmaceutical Co., Ltd. 5.2%
SBI Biolife Science Investment LPS ((1)) 5.1%
BIOVISION Life Science Fund No. 1 ((1)) 4.9%
SBI Incubation Co., Ltd.( (1)) 4.3%
Otsuka Pharmaceutical Factory, Inc. 4.1%
        Goldman Sachs & Co. 3.6%
 
Operating Results and Financial Condition for the Immediately Preceding Three Years
(In thousands of U.S. dollars, except per share data)
        December 31, 2013       December 31, 2014(2)       December 31, 2015
Shareholders’ equity       31,124       184,363       166,434
Total assets       54,048       196,966       175,950
Shareholders’ equity per share (In U.S. dollars)       2.60       5.61       4.63
Net sales       52,947       35,396       24,067
Operating income (loss)       6,994       (188)       (26,556)
Income (loss) before tax       7,182       353       (25,459)
Net income (loss) attributable to common shareholders       1,161       (2,006)       (25,509)
Net income (loss) per share attributable to common shareholders (In U.S. dollars)       0.10       (0.06)       (0.71)
Dividend per share (In U.S. dollars)       0.00       0.00       0.00
                 

Note 1: The aggregate ownership ratio of SBI Holdings, Inc. and its affiliated companies is 21.2% if all shares owned or controlled by affiliated persons or companies are included.

Note 2: The Company was listed on the Mothers market of the TSE.

(2) U.S. Subsidiary (as of March 29, 2016)

         
(1) Company Name       Acucela North America Inc.
(2) Address       Seattle, Washington, U.S.A.
(3) Name and Title of Representative       Ryo Kubota, Chairman, President and Chief Executive Officer
(4) Principal Business       A clinical stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases affecting millions of people worldwide.
(5) Capital Amount       $1.00
(6) Date of Establishment       March 24, 2016 (Pacific Daylight Time)
(7) Total Number of Shares Issued       1,000
(8) Fiscal Year End       December 31
(9) Number of Employees       2
(10) Main Banks       Not applicable
(11) Major Shareholders and Shareholding Ratio       Acucela Japan Kabushiki Kaisha 100%
(12) Operating Results and Financial Condition for the Immediately Preceding Three Years       US Subsidiary was established on March 24, 2016 (Pacific Daylight Time) and therefore no business year has been completed.
     

4. Status of the Japan Holding Company Following the Triangular Merger (Planned)

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  •          
    (1) Company Name       Acucela Japan Kabushiki Kaisha
            (English name: Acucela Japan KK)
    (2) Address       Shibuya-ku, Tokyo
    (3) Name and Title of Representative      

    Ryo Kubota, Representative Director, Chairman, President and Chief Executive Officer

    (4) Persons to Assume the Office of Directors

    Ryo Kubota, Representative Director, Chairman, President and Chief Executive Officer

    Shintaro Asako, Director