2013 ANNUAL REPORT TO STOCKHOLDERS · dv zhoo dv surwhfwlqj wkh uhwlqd iurp oljkw gdpdjh 7kh ylvxdo...
Transcript of 2013 ANNUAL REPORT TO STOCKHOLDERS · dv zhoo dv surwhfwlqj wkh uhwlqd iurp oljkw gdpdjh 7kh ylvxdo...
2013
ANNUAL REPORT TO STOCKHOLDERS
www.acucela.com
Dear Shareholders,
Acucela has a clear and precise corporate definition - we are a clinical-stage biotechnology company that specializes in discovering and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases impacting millions of individuals worldwide.
Acucela’s mission is:
To address unmet medical needs in sight-threatening diseases through scientific innovations
To build a unique company with continuous value creation for society To create an excellent working environment and quality of life for employees
Our business model has three strategically important foundational components that we expect will drive the Company’s growth in the large, underserved ophthalmic disease market:
Strong and differentiated science: A franchise opportunity in Visual Cycle Modulation (VCM), with one compound currently in a Phase 2b/3 trial and several other VCM compounds under development;
Robust research and development infrastructure: Demonstrated capabilities in ophthalmic research and clinical development; and
Long-standing strategic partnership: Partnered multiple programs with Otsuka Pharmaceutical, a global diversified healthcare company based in Japan.
The Pursuit of Innovation – A Pioneer in Visual Cycle Modulation (VCM) At the heart of our innovative culture is the development and advancement of our proprietary visual cycle modulation (VCM) compounds. The visual cycle is the biological conversion of a photon into an electrical signal in the retina. During exposure to bright light, the visual cycle is extremely active and can produce toxic by-products which cannot be eliminated. Over time, accumulation of these toxic by-products can compromise function of the visual cycle and damage the retina.
Acucela’s VCM compounds are designed to reduce the effects of toxic by-products and oxidative damage as well as protect the retina from light damage. Based on preclinical data, we believe that our VCM-based drug candidates have the potential to demonstrate significant advantages over other therapies.
An Unmet Need in Dry Age-related Macular Degeneration (dry AMD) Age-related macular degeneration is associated with irreversible vision loss in severe cases. More than 10 million people in the United States and more than 120 million people worldwide are affected by AMD.1 Geographic atrophy (GA) is an advanced stage of dry AMD which can lead to legal blindness. There is currently no therapy approved by the Food and Drug Administration to treat dry AMD.
Emixustat hydrochloride is the first internally developed compound by Acucela and our lead VCM product candidate in development to treat GA associated with dry AMD. Emixustat is orally dosed, and has been demonstrated to be generally safe and well-tolerated in completed clinical studies. Emixustat is currently being studied in a Phase 2b/3 clinical trial for the treatment of GA associated with dry AMD. We look forward to continuing to advance this clinical trial in 2014.
2013/early 2014 Company Highlights
We were pleased to announce in 2013/early 2014 that we: - Completed enrollment in the emixustat Phase 2b/3 clinical trial (March 2014); - Appointed Brian O’Callaghan to our Board of Directors (September 2013); - Reached 50% enrollment in the emixustat Phase 2b/3 clinical trial (August 2013);- Announced with our partner, Otsuka Pharmaceutical, the presentation of Phase 2a clinical
results of emixustat in patients with GA associated with dry AMD at the ARVO 2013 Annual Meeting (May 2013);
- Initiated a Phase 2b/3 clinical trial of emixustat in subjects with GA associated with dry AMD (April 2013); and
- Appointed Hans Peter Pfleger, PhD as Vice President Commercial Operations & Strategic Marketing (January 2013).
And, of course, we completed our initial public offering (IPO) in February 2014, raising a net of just over $140M and becoming the first US company to solely list on the Mothers Board of the Tokyo Stock Exchange (ticker symbol: 4589).
Thank you for your continued support as we strive to advance Acucela to its next stage as a company.
Sincerely,
Ryo Kubota, MD, PhD Chairman, President & CEO Acucela Inc.
(1) 2012 Comprehensive Report on The Global Retinal Pharmaceuticals & Biologics Market, Market Scope.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
Commission File Number 000-55133
ACUCELA INC. (Exact name of registrant as specified in its charter)
Washington 02-0592619
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification Number)
1301 SECOND AVENUE, SUITE 1900 SEATTLE, WASHINGTON
98101
(Address of principal executive offices) (Zip Code)
(206) 805-8300
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, No Par Value Per Share
ACUCELA INC. FORM 10-K
For the fiscal year ended December 31, 2013 INDEX
PART I
PART II
PART III
PART IV
FORWARD-LOOKING STATEMENTS
ITEM 1. BUSINESS
Overview
Product Overview
Overview
Emixustat for Age-related Macular Degeneration
Disease Overview.
Product Candidate.
Development Status
Phase 2b/3 Study
Other Potential Markets for Our VCM-Based and Retinal Product Candidates
Diabetic Retinopathy / Diabetic Macular Edema.
Disease Overview.
Product Candidate.
Development Status.
Other Ophthalmic Diseases.
Stargardt Disease
Retinopathy of Prematurity
Retinitis Pigmentosa
OPA-6566 for Glaucoma
Disease Overview.
Product Candidate.
Development Status.
Collaborations with Otsuka
Emixustat hydrochloride
OPA-6566
Intellectual Property
Visual Cycle Modulation
OPA-6566
Other Technologies
Competition
Dry AMD
Glaucoma
Sales and Marketing
Financial Information about Segments and Geographic Areas
Research and Development
Manufacturing and Supply
Government and Other Regulation
General Overview
United States
Phase 1:
Phase 2:
Phase 3:
Phase 4:
Post-Approval Requirements
Fast Track Designation
Other Regulatory Considerations
Patent Term Restoration and Marketing Exclusivity
Third-Party Payor Coverage and Reimbursement
The Physician Payment Sunshine Act
Foreign Regulations
Employees
ITEM 1A. RISK FACTORS
Risks Related to Our Business and Industry
We do not have any products that are approved for commercial sale.
Revenues from research and development activities in collaboration with Otsuka and Otsuka’s funding of our portion of development costs under the Emixustat Agreement represented all of our revenues during the three years ended December 31, 2013, and the loss of these revenues would adversely affect our business.
Business—Collaborations with Otsuka
Our long-term prospects are dependent on our product candidates and we cannot be certain that they will achieve success in clinical trials, regulatory approval or be successfully commercialized.
Even if clinical trials are successful in the future, our growth prospects could be adversely affected and we may need to curtail or cease operations if we do not pursue the optimal commercialization strategy for us under our collaboration agreements.
The pharmaceutical market is intensely competitive. Even if we are successful in obtaining approval of any of our product candidates, we may be unable to compete effectively with existing drugs, new treatment methods and new technologies.
Business—Competition
Market acceptance of emixustat and other products we develop in the future may be limited.
Our historical results of operations may not be indicative of our future profitability or growth, and we may not be able to continue to maintain or increase our profitability or growth.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Our operating results may fluctuate in the future, which could cause our stock price to decline.
Our planned investment in building a sales and marketing capability will require significant resources and may not generate the return we anticipate.
We may not be successful in our efforts to expand our portfolio of product candidates.
Relying on third-party manufacturers may result in delays in our clinical trials and product introductions.
We are dependent on our management team, particularly Ryo Kubota, M.D., Ph.D., our founder and chief executive officer, and if we are unable to retain and motivate our key management and scientific staff, our drug development programs may be delayed and we may be unable to successfully develop or commercialize our product candidates.
Our workforce reduction may impact the performance of our continuing personnel, and make it more difficult to retain the services of key personnel.
If any products we develop become subject to third-party reimbursement practices, unfavorable pricing regulations or healthcare reform initiatives, our business could be harmed.
In order to achieve our commercialization goals, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
We face the risk of product liability claims and may not be able to obtain insurance, and we may have exposure to significant contingent liabilities.
We may need additional financing, which may be difficult to obtain. Our failure to obtain necessary financing or doing so on unattractive terms could adversely affect our development programs and other operations.
We are an “emerging growth company,” and any decision on our part to comply only with certain reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.
Regulatory Risks
We may not be able to obtain regulatory approval for any of the products resulting from our development efforts, including emixustat and OPA-6566. Failure to obtain these approvals could materially harm our business.
The “fast track” designation for development of emixustat for dry macular degeneration (geographic atrophy) may not actually lead to a faster regulatory review or approval process.
Our products could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements, or if we experience problems with our products, when and if any of them are approved.
Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products outside of the United States.
Risks Relating to Intellectual Property and Other Legal Matters
If our efforts to protect the proprietary nature of the intellectual property related to our products are not adequate, we may not be able to compete effectively in our markets.
Business—Intellectual Property
If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
Third-party claims of intellectual property infringement may prevent or delay our discovery, development and commercialization efforts with respect to emixustat and our other product candidates.
We may become involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.
If we use hazardous or biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
Risks Related to Ownership of Our Common Stock
The price of our common stock may be volatile, and you could lose all or part of your investment.
The price of our stock could decrease as a result of shares being sold in the market.
As a public company, we will be subject to additional financial and other reporting and corporate governance requirements that may be difficult for us to satisfy, will raise our costs and may divert resources and management attention from operating our business.
Any future issuance of equity or debt securities by us may adversely affect the rights or value of our previously issued common stock.
Because the principal trading market for our shares is the Mother’s market of the Tokyo Stock Exchange, the corporate governance rules of the major U.S. stock exchanges will not apply to us. As a result, our governance practices may differ from those of a company listed on such U.S. exchanges.
A limited number of shareholders will have the ability to influence the outcome of director elections and other matters requiring shareholder approval.
Anti-takeover provisions under Washington law could make an acquisition of us more difficult and affect the market price of our common stock.
We do not expect to pay dividends in the foreseeable future. As a result, you must rely on stock appreciation for any return on your investment.
ITEM 1B. UNRESOLVED STAFF COMMENTS
ITEM 2. PROPERTIES
ITEM 3. LEGAL PROCEEDINGS
ITEM 4. MINE SAFETY DISCLOSURES
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Holders of Common Stock
Dividends
Recent Sales of Unregistered Securities
Use of Proceeds
Share Repurchases
ITEM 6. SELECTED FINANCIAL DATA
Years Ended December 31,
Statements of Income Data: 2013 2012 2011 (in thousands, except per share data)
As of December 31,
Balance Sheet Data: 2013 2012 (in thousands)
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This Report, including the “Management's Discussion and Analysis of Financial Condition and Results of Operations,” contains forward-looking statements regarding future events and our future results that are based on our current expectations, estimates, forecasts, and projections about our business, our results of operations, the industry in which we operate and the beliefs and assumptions of our management. Words such as “expects,” “anticipates,” “targets,” “goals,” “projects,” “would,” “could,” “intends,” “plans,” “believes,” “seeks” and “estimates,” variations of these words, and similar expressions are intended to identify those forward-looking statements. These forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, those discussed in this Report under the section entitled “Risk Factors” in Item 1A of Part I and elsewhere herein, and in other reports we file with the SEC. While forward-looking statements are based on reasonable expectations of our management at the time that they are made, you should not rely on them. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, whether as a result of new information, future events or otherwise, except as may be required by law.
Overview
Critical Accounting Policies and Estimates
Revenue Recognition
Multiple Element Arrangements
Substantive Milestone Payments
Deferred Revenue
Funded Development
Research and Development and Clinical Trial Accounting
Income Taxes
Tax Loss Carryforwards
Uncertain Tax Positions
Stock-Based Compensation
Volatility.
Expected term.
Risk-free interest rate.
Dividend yield.
Fair value of underlying stock.
Valuation of Privately-Held-Company Equity Securities Issued as Compensation
Description of Operating Accounts
Revenue
Research and development
General and administrative
Interest income
Interest expense
Other income (expense)
Income tax benefit (expense)
Results of Operations
Year Ended December 31, 2012 to 2013 % Change
Year Ended December 31, 2011 to 2012 % Change 2013 2012 2012 2011
Year ended December 31, 2013 compared to the year ended December 31, 2012
Revenues from collaborations with related party
Years Ended December 31, 2012 to 2013 $ Change
2012 to 2013 % Change 2013 2012
Proprietary
In-Licensed
Expenses.
Research and development.
Years Ended December 31, 2012 to 2013 $ Change
2012 to 2013 % Change 2013 2012
Proprietary
In-Licensed
Internal Research
General and administrative
Income tax expense
Year ended December 31, 2012 compared to the year ended December 31, 2011
Revenues from collaborations with related party.
Year Ended December 31, 2011 to 2012 $ Change
2011 to 2012 % Change 2012 2011
Proprietary
In-Licensed
VCM Research
Expenses.
Research and development.
Years Ended December 31, 2011 to 2012 $ Change
2011 to 2012 % Change 2012 2011
Proprietary
In-Licensed
Internal Research
General and administrative.
Income tax benefit (expense)
Liquidity and Capital Resources
Years Ended December 31, 2013 2012 2011
Cash Flows From Operating Activities
Cash Flows From Investing Activities
Cash Flows From Financing Activities
Contractual Obligations and Commitments
Payments Due by Period
Total Less than
1 Year 1-3 Years 3-5 Years More than
5 Years
Co-Development and Co-Promotion Options
Strategic Restructuring
Contingently Repayable Advances
Off-Balance Sheet Transactions
JOBS Act
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate and Credit Quality Risk
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Management’s Report on Internal Control over Financial Reporting
Changes in Internal Control Over Financial Reporting
ITEM 9B. OTHER INFORMATION
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Executive Officers of the Registrant
Name Age Position(s)
Ryo Kubota, M.D., Ph.D.
David L. Lowrance
Hien DeYoung
Directors
Name Age
Executive Officers of the Registrant
Peter A. Kresel
Glen Y. Sato
Michael T. Schutzler
Brian O’Callaghan
Section 16(a) Beneficial Ownership Reporting Compliance
Code of Business Conduct and Ethics
Identification of Audit Committee and Financial Expert
ITEM 11. EXECUTIVE COMPENSATION
Summary Compensation
Summary Compensation Table
Name and principal position Year Salary Bonus Stock
Awards(1) Option Awards
Non-Equity Incentive
Plan Compen- sation(2)
All Other Compen-
sation Total(3)
2013 Stock Awards
—Executive Employment Arrangements—Ryo Kubota, M.D., Ph.D
Non-Equity Incentive Plan Compensation
Named Executive Officer
Corporate Goals and Objectives
Individual Goals and Objectives
Named Executive Officer Actual Award Amount
Outstanding equity awards at December 31, 2013
Option awards Stock awards
Number of Securities Underlying
Unexercised Options Option Exercise Price(1)
Option Expiration
Date
Number of Shares of Stock
that Have Not Vested(2)
Market Value of Shares of Stock
that Have Not Vested(3) Name Exercisable Unexercisable
Management’s Discussion and Analysis of Financial Condition and Results of Operation—Critical Accounting Policies and Estimates—Stock-Based Compensation
Executive Employment Arrangements
Ryo Kubota, M.D., Ph.D.
2013 Stock Awards
David L. Lowrance
Hien DeYoung
Compensation Committee Interlocks and Insider Participation
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Security Ownership of Certain Beneficial Owners and Management
Name and Address of Beneficial Owner
Shares Beneficially Owned
Percent 5% Shareholders
Officers and Directors
Equity Compensation Plan Information
Number of Securities to be Issued Upon
Exercise of Outstanding Options
Weighted Average Exercise Price of
Outstanding Options
Number of Securities Remaining Available for Future Issuance
Under Equity Compensation Plans (Excluding Securities Reflected in Column
(a))
Plan Category (a) (b) (c)
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
Transactions with Otsuka
Collaborations with Otsuka.
Item 1. Business-Collaborations with Otsuka
Arrangement with Otsuka.
Contingently Convertible Debt with SBI
Holder Principal
Current Interest
Rate Maturity Date
Interest Paid Since
January 2012
Amount Outstanding
as of December 31,
2013
Total
Consulting Relationship
Loans to Executive Officers
Executive Compensation—Summary Compensation—2013 Stock Awards Executive Compensation—Executive Employment Arrangements—Ryo Kubota, M.D., Ph.D.
Review, Approval or Ratification of Transactions with Related Parties
Independence of Directors
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Information Regarding our Independent Registered Public Accounting Firm
2013 2012
Audit Fees.
Audit-Related Fees.
Tax Fees.
All Other Fees.
Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Registered Public Accounting Firm
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
SIGNATURES
ACUCELA INC.
Incorporated by Reference Exhibit Number
Filed Herewith Form
Period Ending Exhibit Filing Date
ACUCELA INC. INDEX TO FINANCIAL STATEMENTS
Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
ACUCELA INC. BALANCE SHEETS
(in thousands)
December 31, 2013 2012
Assets
Liabilities and shareholders’ equity
ACUCELA INC. STATEMENTS OF INCOME
(in thousands, except per share data)
Year Ended December 31,
2013 2012 2011
ACUCELA INC.
STATEMENTS OF COMPREHENSIVE INCOME (in thousands)
Year Ended December 31, 2013 2012 2011
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ACUCELA INC.
STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended December 31,
2013 2012 2011 Cash flows from operating activities
Cash flows from investing activities
Cash flows from financing activities
Supplemental disclosure
ACUCELA INC.
NOTES TO FINANCIAL STATEMENTS
Note 1. Summary of Business and Significant Accounting Policies
Overview
Use of Estimates
Cash and Cash Equivalents
Investments
Restricted Investments
Accounts Receivable
Property and Equipment
Revenue Recognition
Multiple Element Arrangements
Substantive Milestone Payments
Deferred Revenue
Income Taxes
Stock-Based Compensation
Expected Term
Expected Volatility
Expected Dividend
Risk-Free Interest Rate
Years ended December 31, 2013 2012 2011
Research and Development Costs
Deferred Offering Costs
Note 2. Net Income Per Share
Year Ended December 31, 2013 2012 2011
Note 3. Concentration of Risk
Note 4. Segment Reporting
Note 5. Collaboration and License Agreements
Emixustat Collaboration
Revenue Recognition-Milestone Method
OPA-6566 Collaboration
Rebamipide Collaboration
Continued Involvement of the CEO
Note 6. Investments and Cash and Cash Equivalents
December 31, 2013
Amortized Cost
Gross Unrealized Fair
Value Holding Gains
Holding Losses
December 31, 2012
Amortized Cost
Gross Unrealized Fair
Value Holding Gains
Holding Losses
Note 7. Fair Value Measurements
December 31, 2013
Level 1 Level 2 Level 3 Total
December 31, 2012
Level 1 Level 2 Level 3 Total
Note 8. Property and Equipment
December 31,
2013 2012
Note 9. Contingently Convertible Debt with Related Party
Note 10. Income Taxes
December 31,
2013 2012
Year Ended December 31,
2013 2012 2011
Year Ended December 31,
2013 2012 2011
Note 11. Commitments
Leases
Credit Facility
Note 12. Shareholders’ Equity
Common Stock
Convertible Preferred Stock
Conversion
Liquidation
Dividends
Voting
Changes in Accumulated Other Comprehensive Loss (in thousands):
Year Ended December 31,
2013 2012
Note 13. Stock-Based Compensation
Stock Option Plan
Shares Available for Grant
Number of Option Shares Outstanding
Weighted Average Exercise Price of
Option Shares Options
Exercisable
December 31, 2013
Exercise Prices
Number of Option Shares
Weighted Average Remaining Contractual Life
(Years) Options Exercisable
CEO Equity Agreement
Note 14. 401(k) Retirement Plan
Note 15. Related-Party Transactions
Note 16. Strategic Restructuring
Severance and Other Termination Benefits
Note 17. Subsequent Events
Initial Public Offering
December 31, 2013
Pro forma December 31, 2013
Note 18. Quarterly Information (Unaudited)
March 31 June 30 September 30 December 31
(In thousands, except per share amounts)
2013
March 31 June 30 September 30 December 31
(In thousands, except per share amounts)
2012
EXECUTIVE OFFICERS
Ryo Kubota, MD, PhD Chairman, President and Chief Executive Officer Dave Lowrance, CPA Chief Financial Officer, Corporate Secretary and Treasurer Hien DeYoung, CHIC, SPHR Vice President, Human Resources
BOARD OF DIRECTORS
Ryo Kubota, MD, PhD Chairman, President and Chief Executive Officer Peter Kresel Senior Vice President of Global Regulatory Affairs, Allergan (retired) Brian O’Callaghan Chairman and CEO, Sonrgy Inc. Glen Sato, JD Partner, Cooley LLP Michael Schutzler CEO, The Washington Technology Industry Association (WTIA)
SHAREHOLDERS’ INFORMATION
Corporate Headquarters 1301 Second Avenue, Suite 1900 Seattle, WA 98101-3805 (206) 805-8300 www.acucela.com
Annual Shareholders Meeting 1 p.m. Pacific Time, Thursday, June 5, 2014 Acucela Inc. Corporate Headquarters 1301 Second Avenue, Suite 1900 Seattle, WA 98101-3805
Stock Listing Acucela common stock is listed under the code 4589 on the Mothers Market of the Tokyo Stock Exchange.
Transfer Agent Computershare Shareholder Relations P.O. Box 30170 College Station, TX 77842-3170 877-522-7762 Outside U.S.: 201-680-6578 www.computershare.com/investor
Forward-Looking Statements The statements contained in this report that are not purely historical are forward-looking statements. These statements include, but are not limited to, statements about our plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances. These statements are generally identified by the words “expects,” anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions. These forward-looking statements are based on current information and expectations and are subject to a number of risks and uncertainties, 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. Our actual results could differ materially and adversely from those expressed or implied by these forward-looking statements. For a detailed description of our risks and uncertainties, you are encouraged to review the documents filed with the Securities and Exchange Commission. We assume no obligation to revise or update any such forward-looking statements.
1301 Second AvenueSuite 1900, 19th Floor
Seattle, WA 98101-3805206.805.8300
www.acucela.com