Securities and exchange commission


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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 20-F

 

¨

REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

 

x

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2015

 

OR

 

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

 

o

SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report ________________

 

Commission file number 001-35773

 

 

RedHill Biopharma Ltd.

 

 

(Exact name of Registrant as specified in its charter)

 

 

 

 

 

N/A

 

 

(Translation of Registrant’s name into English)

 

 

 

 

 

Israel

 

 

(Jurisdiction of incorporation or organization)

 

 

21 Ha’arba’a Street, Tel Aviv 64739, Israel

(Address of principal executive offices)

 

Ori Shilo, Deputy Chief Executive Officer Finance and Operations

21 Ha’arba’a Street, Tel Aviv 64739, Israel

Tel: 972-3-541-3131; Fax: 972-3-541-3144

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

 

Title of class

 

Name of each exchange on which registered

American Depositary Shares, each representing ten Ordinary Shares (1)

 

Nasdaq Capital Market

 

 

 

Ordinary Shares, par value NIS 0.01 per share (2)

 

Nasdaq Capital Market

 

(1)

Evidenced by American Depositary Receipts.

(2)

Not for trading, but only in connection with the listing of the American Depositary Shares.

 

Securities registered or to be registered pursuant to Section 12(g) of the Act:

 

None

(Title of Class)

 

1

 

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:

 

None

(Title of Class) 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: 127,114,294

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

 

Yes ☐    No   ý

 

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act 1934.

 

Yes ☐    No   ý

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

ý Yes    No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

 

 Yes o    No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large Accelerated filer o

Accelerated filer ý

Non-accelerated filer o

 

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

 

U.S. GAAP o

 

International Financing Reporting Standards as issued by the International Accounting

 

Standards Board ý

Other o

 

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

 

Item 17 [  ] Item 18  [  ]

 

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

Yes  o    No   ý

 

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and, as such, may elect to comply with certain reduced public company reporting requirements.

 

2

 

TABLE OF CONTENTS

 

ITEM 1.

IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

5

ITEM 2.

OFFER STATISTICS AND EXPECTED TIMETABLE

5

ITEM 3.

KEY INFORMATION

5

ITEM 4.

INFORMATION ON THE COMPANY

26

ITEM 4A.

UNRESOLVED STAFF COMMENTS

56

ITEM 5.

OPERATING AND FINANCIAL REVIEW AND PROSPECTS

56

ITEM 6.

DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

64

ITEM 7.

MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

80

ITEM 8.

FINANCIAL INFORMATION

81

ITEM 9.

THE OFFER AND LISTING

82

ITEM 10.

ADDITIONAL INFORMATION

84

ITEM 11.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

95

ITEM 12.

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

96

ITEM 13.

DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES

97

ITEM 14.

MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS

97

ITEM 15.

CONTROLS AND PROCEDURES

97

ITEM 16.

[RESERVED]

98

ITEM 16A.

AUDIT COMMITTEE FINANCIAL EXPERT

98

ITEM 16B.

CODE OF ETHICS

98

ITEM 16C.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

98

ITEM 16D.

EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES.

99

ITEM 16E.

PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS.

99

ITEM 16F.

CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT.

99

ITEM 16G.

CORPORATE GOVERNANCE

99

ITEM 16H.

MINE SAFETY DISCLOSURE

100

ITEM 17.

FINANCIAL STATEMENTS

100

ITEM 18.

FINANCIAL STATEMENTS

100

ITEM 19.

EXHIBITS

100

EXHIBIT INDEX

103

______________________________________________________________________________

 

3

 

Unless the context otherwise requires, all references to “RedHill,” “we,” “us,” “our,” the “Company” and similar designations refer to RedHill Biopharma Ltd. The term “NIS” refers to New Israeli Shekels, the lawful currency of the State of Israel, the terms “dollar”, “US$” or “$” refer to U.S. dollars, the lawful currency of the U.S. Our functional and presentation currency is the U.S. dollar. Unless otherwise indicated, U.S. dollar amounts herein (other than amounts originally receivable or payable in dollars) have been translated for the convenience of the reader from the original NIS amounts at the representative rate of exchange as of February 22, 2016 ($1 = NIS 3.907). The dollar amounts presented should not be construed as representing amounts that are receivable or payable in dollars or convertible into dollars, unless otherwise indicated. Foreign currency transactions in currencies other than the U.S. dollar are translated in this Annual Report into U.S. dollars using exchange rates in effect at the date of the transactions.

 

All references to the term “therapeutic candidates” include both pharmaceuticals and programs related to their development, such as diagnostics and devices.

 

________________________________

 

FORWARD-LOOKING STATEMENTS

 

Some of the statements under the sections entitled “Item 3. Key Information - Risk Factors,” “Item 4. Information on the Company,” “Item 5. Operating and Financial Review and Prospects” and elsewhere in this Annual Report may include forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. In addition, the sections of this Annual Report entitled “Item 4. Information on the Company” contain information obtained from independent industry and other sources that we have not been independently verified. You should not put undue reliance on any forward-looking statements. Unless we are required to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements.

 

Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to

 



the initiation, timing, progress and results of our research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, as well as the extent and number of additional studies that we may be required to conduct;



our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;



our receipt of regulatory clarity and approvals for our therapeutic candidates, and the timing of other regulatory filings and approvals;



the research, manufacturing, clinical development, commercialization, and market acceptance of our therapeutic candidates;



our ability to establish and maintain corporate collaborations;



our ability to acquire products approved for marketing in the U.S. that achieve commercial success and build our own marketing and commercialization capabilities;



the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in research, manufacturing, preclinical studies or clinical trials;



the implementation of our business model, strategic plans for our business and therapeutic candidates;



the scope of protection we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to operate our business without infringing upon the intellectual property rights of others;



estimates of our expenses, future revenues capital requirements and our need for additional financing;



competitive companies, technologies and our industry; and



the impact of the political and security situation in Israel on our business.

___________________________________

 

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