Acucela-2014.08 KT Forecast

0001400482-14-000033.txt : 20140812 0001400482-14-000033.hdr.sgml : 20140812 20140812060910 ACCESSION NUMBER: 0001400482-14-000033 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20140812 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140812 DATE AS OF CHANGE: 20140812 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ACUCELA INC. CENTRAL INDEX KEY: 0001400482 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 020592619 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-55133 FILM NUMBER: 141032368 BUSINESS ADDRESS: STREET 1: 1301 SECOND AVE. STREET 2: SUITE 1900 CITY: SEATTLE STATE: WA ZIP: 98101 BUSINESS PHONE: 206-805-8300 MAIL ADDRESS: STREET 1: 1301 SECOND AVE. STREET 2: SUITE 1900 CITY: SEATTLE STATE: WA ZIP: 98101 FORMER COMPANY: FORMER CONFORMED NAME: Acucela Inc DATE OF NAME CHANGE: 20070523 8-K 1 acucela-201408ktforecast.htm 8-K Acucela-2014.08 KT Forecast

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): August 12, 2014

ACUCELA INC.

(Exact name of registrant as specified in its charter)




Washington	000-5513	02-0592619
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

1301 Second Avenue, Suite 1900

Seattle, Washington 98101

(Address of principal executive offices, including zip code)

(206) 805-8300

(Registrant’s telephone number, including area code)

Not applicable.

(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))

Item 2.02. Results of Operations and Financial Condition.

On August 12, 2014 (Japanese Standard Time), Acucela Inc. (the “Company”) filed with the Tokyo Securities Exchange a Japanese report entitled "Revisions to Full-Year Earnings Forecasts," which contained the Company's unaudited financial results for the six months ended June 30, 2014, as well as supplemental information related to a financial results forecast for the six months ended June 30, 2014 (the "Report"). A copy of the English translation of the Report is attached hereto as Exhibit 99.1.

The information furnished in this Form 8-K, including the exhibit hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

The statements contained in the Report regarding projected financial results for the year ending December 31, 2014 are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company has based these forward-looking statements largely on its expectations and projections about future events and financial trends affecting the financial condition and/or operating results of its business. These statements involve risks and uncertainties that could cause the Company’s actual results to differ materially, including, but not limited to the risk that our product candidates will not demonstrate the expected benefits and will not achieve regulatory approval or be successfully commercialized, the success of our product candidates depends heavily on the willingness of our collaboration partner to continue to co-develop our product candidates, the risk of delays in our expected clinical trials, the risk that new developments in the intensely competitive ophthalmic pharmaceutical market require changes in our clinical trial plans or limit the potential benefits of our product candidates, our dependence on and our ability to retain and motivate our key management and scientific staff, including Ryo Kubota, M.D., Ph.D., and other risks and uncertainties inherent in the process of discovering and developing therapeutics that demonstrate safety and efficacy. For a detailed discussion of these and other risk factors, please refer to the Company’s filings with the Securities and Exchange Commission, which are available on the Company’s investor relations Web site (http://ir.acucela.com/) and on the SEC’s Web site (http://www.sec.gov).

Item 9.01. Financial Statements and Exhibits

(d) Exhibits



Exhibit	Description
99.1	English translation of Revisions to Full-Year Earnings Forecasts dated August 12, 2014.

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.

	By:	/s/ David L. Lowrance
		David L. Lowrance
Date: August 12, 2014		Chief Financial Officer, Treasurer and Secretary

EXHIBIT INDEX



Exhibit Number	Description
99.1	English translation of Revisions to Full-Year Earnings Forecasts dated August 12, 2014.

EX-99.1 2 acucela201408ktforecastexh.htm ENG. TRANSLATION OF REVISION TO FULL-YR. EARNINGS FORECASTS DATED 8/12/14. Acucela 2014.08 KT Forecast Exhibit

(Translation)

August 12, 2014



Company name:	Acucela Inc.
Representative:	Ryo Kubota, Chairman, President and CEO
Code No.:	4589, TSE Mothers
Person to contact:	Tomomi Sukagawa, Director
	Japan Office, Acucela Inc.
	TEL: 81-3-5789-5872 (main)
Attorney in fact:	Ken Takahashi, Attorney at law
	Baker & Makenzie
	(Gaikokuho Joint Enterprise)
	TEL: 81-3-6271-9900

Revisions to Earnings Forecasts

Based on the recent business performance, we have revised the earnings forecasts announced on February 13, 2014 as follows:

***

Revisions to the Forecast for the Earnings for 2Q 2014 (accumulated)

(January 1, 2014 to June 30, 2014)



(Unit: US$ in thousands (JPY in thousands), except per share information)
	Revenue from collaborations (Note 1)		Operating Income		Income before income tax		Net income		Net income per share
Previous Forecast (A)	29,683		401		208		127		0.01
	(3,008,668)		(40,645)		(21,082)		(12,872)		(1)
Revised Forecast (B)	19,632		319		504		125		0.00
	(1,989,899)		(32,334)		(51,085)		(12,670)		(0)
Change (B-A)	-10,051		-82		296		-2		-0.01
	((1,018,769))		((8,311))		(30,003)		((202))		((1))
Percentage Change (%)
	-34	%	-20	%	142	%	-2	%	-100	%
2Q 2013 (accumulated)	27,003		5,643		5,675		3,691		0.08
	(2,737,024)		(571,975)		(575,218)		(374,120)		(8)

Note: Amounts in parenthesis are converted amounts (JPY in thousands except for per share amounts (JPY)) at the rate of 1 USD = 101.36, which were the TTM rates quoted by The Bank of Tokyo-Mitsubishi UFJ, Ltd. on June 30, 2014 for the sake of convenience.

Reasons for revisions

Revenue from collaborations. The decrease in the company's total revenue is directly correlated to the same variance in expenses for individual projects, resulting in no impact to the company's net income. First half 2014 total revenue was $10.1 million, or ¥1,018.8 million, below the forecast ($19.6 million, or ¥1,989.9 million, Revised Forecast vs. $29.7 million, or ¥3,008.7 million, Previous Budget) of which approximately $10 million is directly correlated to the same variance in expenses associated with the emixustat program, thus no impact on net income. As noted in our Press Release dated May 9, 2014, based on the recommendation from the FDA, Acucela will not be pursuing a 12 month analysis of our Phase 2b/3 “SEATTLE” study. As a result, schedules of the clinical development activities, including the interim analysis, have been changed, resulting in lower revenue and expense for the first half of 2014. The remaining variance in total revenue can be attributed to the glaucoma program.

Operating income. The variance in operating income can be attributed to the performance of the glaucoma program.

Income before income tax. The $0.3 million , or ¥30.0 million, stronger performance in income before income tax can be attributed to better than forecasted interest income and lower than expected foreign exchange expenses.

Net income and net income per share. Due to a higher than anticipated US tax rate, net income was $0.002 million, or ¥0.2 million, less than the forecast. Net income per share was $0.01, or ¥1, less than the forecast.

Forecast for 2014. The shift in the timing of Phase 2b/3 “SEATTLE” study-related activities will have no impact on net income or net income per share for 2014, due to the nature of revenue and expenses as explained above. Potential impact on full-year revenue and expense for 2014 cannot be determined at this point. Therefore, we have not revised the 2014 full-year forecast.

(Notes) The forecasts above are based on the information currently available. A number of factors

could cause actual results to differ materially from expectations.

END