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Form 6-K RedHill Biopharma Ltd. For: Apr 30

April 30, 2015 7:02 AM
UNITED STATES   
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 6-K
  
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
 
For the month of April 2015
Commission File No.:001-35773
 
REDHILL BIOPHARMA LTD.
(Translation of registrant’s name into English)

21 Ha'arba'a Street, Tel Aviv, 64739, Israel
 (Address of principal executive offices)
 
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F. 
Form 20-F S Form 40-F £
 
Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____ 
 
Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____ 
 
Attached hereto and incorporated by reference herein are the following:
 
Exhibit 1: Registrant's press release entitled "RedHill Biopharma Reports Results for the First Quarter of 2015".
 
Exhibit 2: Registrant’s condensed interim unaudited financial information as of March 31, 2015 and for the three months then ended.
 
This Form 6-K is incorporated by reference into the Company's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 2, 2013 (Registration No. 333-188286) and its Registration Statement on Form F-3 filed with the Securities and Exchange Commission on January 23, 2014 (Registration No. 333- 193503).
 
 
 

 
Signatures
 
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, thereunto duly authorized. 

 
 
 
Date: April 30, 2015
 
REDHILL BIOPHARMA LTD.
(the "Registrant")
 
By: /s/ Dror Ben-Asher
——————————————
Dror Ben-Asher
Chief Executive Officer

 

EXHIBIT 1

RedHill Biopharma Reports Results for the First Quarter of 2015

Key Highlights Include:

TEL-AVIV, Israel, April 30, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (TASE: RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today reported its financial results for the quarter ended March 31, 2015.

Financial highlights for the three months ended March 31, 2015:

Revenues for the quarter ended March 31, 2015 were immaterial compared to revenues of approximately $7.0 million for the quarter ended March 31, 2014. Revenues for the first quarter of 2014 resulted mainly from an upfront payment of $7.0 million received from Salix Pharmaceuticals, Inc. ("Salix") for the out-licensing of RedHill's RHB-106 encapsulated bowel preparation and related rights.

Research and Development Expenses, net for the quarter ended March 31, 2015 were approximately $3.8 million, an increase of $2.1 million, or approximately 121%, compared to $1.7 million in the first quarter of 2014. The increase was mainly due to expenses related to the ongoing Phase III studies with RHB-104 (Crohn's disease) and BEKINDA(gastroenteritis and gastritis).

General and Administrative Expenses for the quarter ended March 31, 2015 were approximately $0.9 million, a decrease of $0.1 million, or approximately 10%, compared to $1.0 million in the first quarter of 2014. The decrease was mainly due to professional fees incurred during the first quarter of 2014 in connection with the January 2014 financing.

Operating Loss for the quarter ended March 31, 2015 was approximately $4.8 million, a change of $8.1 million, compared to an Operating Income of approximately $3.3 million in the first quarter of 2014. The change resulted mainly from revenues of $7.0 million from the Salix licensing transaction received in the first quarter of 2014.

Net Cash Used in Operating Activities for the quarter ended March 31, 2015 was approximately $3.3 million, compared to Net Cash Provided by Operating Activities of $1.7 million in the first quarter of 2014. The shift resulted mainly from revenues received from the Salix licensing transaction in the first quarter of 2014.

Net Cash Used in Investment Activities for the quarter ended March 31, 2015 was approximately $7.0 million compared to immaterial Net Cash Used in Investment Activities in the first quarter of 2014. The increase was mainly due to investment of cash in short-term bank deposits during the first quarter of 2015.

Net Cash Provided by Financing Activities for the quarter ended March 31, 2015 was $13.2 million, compared to $23.8 million in the first quarter of 2014. The decrease was mainly due to two private placements, for a total of approximately $20 million, and the exercise of warrants, during the first quarter of 2014, partially offset by the public offering of approximately $14.4 million in the first quarter of 2015.

Cash Balance1 as of March 31, 2015 was approximately $32.5 million, compared to $22.9 million for the year ended December 31, 2014. The increase resulted mainly from the closing of the underwritten public offering of approximately $14.4 million in February 2015.

Ori Shilo, Deputy CEO, Finance and Operations said: "We are very pleased with the first quarter 2015 results. During this quarter we strengthened our cash position following the Company's first underwritten public offering in the U.S., supported by reputable investors such as OrbiMed and Broadfin Capital, further validating our promising pipeline of late clinical-stage drugs. We completed an important the acquisition of an exclusive worldwide license to ABC294640, a Phase II-stage, first-in-class, orally-administered SK2 inhibitor targeting multiple oncology and inflammatory-GI diseases. We also made substantial progress in our clinical programs in recent months, including the completion of patient enrollment in the first phase III study with RHB-105 for eradication of H. pylori bacterial infection, and we are very excited about the top-line results from this study which are expected in mid-end June 2015. Our operational expenses during the first quarter of 2015 were in line with expectations, and our cash balance at the end of the quarter remains solid, exceeding $32 million, with no debt, and we are well positioned to execute our plans for the coming year."

1 Including cash, bank deposits and short-term investments.

Operational highlights for the first quarter ended March 31, 2015:

  1. In January 2015, the Company concluded, together with Quest Diagnostics, a pre-submission meeting with the FDA regarding the development path of a commercial companion diagnostic test for the detection of Mycobacterium avium subspecies paratuberculosis (MAP) in Crohn's disease patients. RedHill also announced its intention to initiate a study of approximately 40 Crohn's disease patients to assess the clinical utility of the companion diagnostic test during the second or third quarter of 2015. This study has commenced and is currently underway in the U.S. RedHill further announced that a protocol amendment had been made to the approved IND in relation to the ongoing Phase III MAP US study with RHB-104 for the treatment of Crohn's disease. The protocol amendment significantly increases the number of Crohn's disease patients potentially eligible to enroll in the ongoing Phase III MAP US study. As part of the amendment, the number of subjects planned to be enrolled in the study was increased from 240 to 270. RedHill also reported that it plans to increase the number of clinical sites in the study from 100 to 120 to include new sites in Australia, New Zealand and Europe, along with currently active sites in the U.S., Canada, and Israel.
     
  2. In February 2015, the Company closed its underwritten public offering, which included an over-allotment option exercised in full by the underwriters, for a total of 1,150,000 American Depository Shares ("ADSs"), each representing ten Company ordinary shares, at an offering price of $12.50 per ADS. Gross proceeds from the public offering were approximately $14.4 million, before underwriting discounts and commissions and other offering expenses. Investors in the offering included Broadfin Capital LLC, OrbiMed, Sabby Capital, LLC, Rosalind Advisors, Inc. and others. Wells Fargo Securities acted as lead book-running manager and Roth Capital Partners acted as joint book-running manager. MLV & Co acted as co-manager of the offering.
     
  3. In March 2015, the Company and Apogee Biotechnology Corporation ("Apogee"), a privately-held biotech company located in Hummelstown, Pennsylvania, U.S., entered into an exclusive worldwide license agreement under which RedHill acquired the rights to the Phase II drug candidate ABC294640 and additional intellectual property rights. ABC294640 is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple oncology and inflammatory-GI diseases. Under the terms of the agreement, RedHill acquired the exclusive worldwide development and commercialization rights to ABC294640 and additional intellectual property for all indications. RedHill undertook to pay Apogee an upfront payment of $1.5 million, and an additional amount of $2 million which will be paid on the earlier of (i) a specific date and (ii) reaching a specific development milestone. In addition, the Company undertook to pay up to $2 million in potential development milestone payments, and potential tiered royalties starting in the low double-digits. A Phase Ib/II clinical study with ABC294640 for refractory/relapsed diffuse large B cell lymphoma (DLBCL) is planned to commence in the second quarter of 2015 and will be funded by a $1.5 million grant awarded by the National Cancer Institute under the NIH SBIR/STTR program to Apogee in conjunction with the Louisiana State University Health Science Center. A second Phase II clinical study of ABC294640 for the treatment of multiple myeloma is planned, subject to funding by a pending grant from the National Cancer Institute. A third Phase II clinical study is being planned by RedHill in order to evaluate ABC294640 as a radio-protectant and radiation enhancer in cancer patients undergoing radiotherapy.

Conference Call and Webcast Information:

The Company will host a conference call and an audio webcast on Thursday, April 30, 2015, at 9:00 a.m. ET (16:00 Israel time) to review the first quarter 2015 financial results and business highlights.

To participate in the conference call, please dial the following numbers five to ten minutes prior to the start of the call: United States: +1-718-354-1357; International: +1-877-280-2342; and Israel: +972-3-763-0146. The access code for the call is 5605589.

The conference call will be broadcasted simultaneously and available for replay on the Company's website, http://ir.redhillbio.com/events.cfm, for 30 days. Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

About RedHill Biopharma Ltd.:

RedHill Biopharma Ltd. (Nasdaq: RDHL) (TASE: RDHL) is an emerging Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage, proprietary, orally-administered drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. RedHill's current pipeline of proprietary products includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection, with an ongoing first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease, with an ongoing first Phase III study; (iii) BEKINDA (RHB-102) - a once-daily oral pill formulation of ondansetron with a Phase III study in the U.S. for acute gastroenteritis and gastritis and a European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting submitted in December 2014; (iv) RHB-106 - an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) ABC294640 – a Phase II-stage orally-administered SK2 inhibitor targeting multiple oncology and inflammatory-GI diseases; (vi) MESUPRON® - a Phase II-stage uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; (vii) RP101 - currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (viii) RIZAPORT (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA currently under discussions with the FDA and a European marketing application submitted in October 2014; and (ix) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates; (v) the Company's ability to establish and maintain corporate collaborations; (vi) the interpretation of the properties and characteristics of the Company's therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (vii) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (ix) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (x) estimates of the Company's expenses, future revenues capital requirements and the Company's needs for additional financing (xi) competitive companies and technologies within the Company's industry; and (xii) the impact of the political and security situation in Israel on the Company's business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 26, 2015. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.

REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited)
 
  Three months ended
March 31,
  2015 2014
  U.S. dollars in thousands
REVENUES:    
Licensing revenue -- 7,000
Other revenue 1 5
 
TOTAL REVENUES
1 7,005
COST OF REVENUE -- 1,050
RESEARCH AND DEVELOPMENT EXPENSES, net 3,829 1,736
GENERAL AND ADMINISTRATIVE EXPENSES 927 1,027
OTHER INCOME -- 100
OPERATING INCOME (LOSS) (4,755) 3,292
FINANCIAL INCOME 286 89
FINANCIAL EXPENSES 173 4
FINANCIAL INCOME, net 113 85
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD (4,642) 3,377
     
EARNINGS (LOSS) PER ORDINARY SHARE, (U.S. dollars):    
Basic (0.05) 0.04
Diluted (0.05) 0.04
     
REDHILL BIOPHARMA LTD.  
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION  
(Unaudited)  
   
  March 31, December 31,  
  2015 2014  
  U.S. dollars in thousands  
CURRENT ASSETS      
Cash and cash equivalents 8,474 5,892  
Bank deposits 24,058 17,053  
Prepaid expenses and receivables 2,368 3,074  
  34,900 26,019  
NON-CURRENT ASSETS      
Bank deposits 75 76  
Fixed assets 139 146  
Intangible assets 6,115 2,615  
  6,329 2,837  
T O T A L ASSETS 41,229 28,856  
       
CURRENT LIABILITIES      
Accounts payable and accrued expenses 1,963 1,720  
Intangible assets payable, see note 3 3,500 --  
  5,463 1,720  
       
NON-CURRENT LIABILITIES      
 Derivative financial instruments 1,877 2,125
T O T A L LIABILITIES 7,340 3,845  
 
EQUITY:
     
Ordinary shares 271 240  
Additional paid-in capital 79,099 65,461  
Warrants 1,057 1,528  
Accumulated deficit (46,538) (42,218)  
T O T A L EQUITY 33,889 25,011  
T O T A L LIABILITIES AND EQUITY 41,229 28,856  
 
 
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
  Three months ended March 31,
  2015 2014
  U.S. dollars in thousands
OPERATING ACTIVITIES:    
Comprehensive income (loss) (4,642) 3,377
Adjustments in respect of income and expenses not involving cash flow:    
Share-based compensation to employees and service providers 322 245
Depreciation 9 7
Cost of out-licensing of intangible assets -- 50
Fair value gains on derivative financial instruments (248) (16)
Fair value gains on financial assets at fair value through profit or loss -- 1
Revaluation of bank deposits (4) 2
Exchange differences relating to cash and cash equivalents 167 (84)
  246 205
Changes in assets and liability items:    
Decrease (increase) in prepaid expenses and receivables 706 (716)
Increase (decrease) in accounts payable and accrued expenses 318 (1,190)
  1,024 (1,906)
Net cash provided by (used in) operating activities (3,372) 1,676
INVESTING ACTIVITIES:    
Purchase of fixed assets (2) (25)
Purchase of intangible assets (75) --
Change in investment in current bank deposits (7,000) --
Net cash used in investing activities (7,077) (25)
FINANCING ACTIVITIES:    
Proceeds from issuance of ordinary shares, warrants and derivative financial instruments, net of expenses 13,198 19,364
Exercise of warrants and options into ordinary shares, net of expenses -- 4,464
Net cash provided by financing activities 13,198 23,828
INCREASE IN CASH AND CASH EQUIVALENTS 2,749 25,479
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS (167) 84
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 5,892 11,851
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD 8,474 37,414
Supplementary information on interest received in cash 26 6
Supplementary information on investing activities not involving cash flows - Purchase of intangible assets 3,500 --
CONTACT: Company contact:
         Adi Frish
         Senior VP Business Development &
         Licensing
         RedHill Biopharma
         +972-54-6543-112
         [email protected]
         
         IR contact (U.S.):
         Marcy Nanus
         Senior Vice President
         The Trout Group
         +1-646-378-2927
         [email protected]
EXHIBIT 2
 
 
 
 

 

 
 

 
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
MARCH 31, 2015



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 






 
 

 
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
MARCH 31, 2015




TABLE OF CONTENTS

 
 
Page
UNAUDITED FINANCIAL STATEMENTS AS OF MARCH 31, 2015 - IN U.S. DOLLARS:
 
Condensed interim statements of comprehensive income (loss)
2
Condensed interim statements of financial position
3
Condensed interim statements of changes in equity
4
Condensed interim statements of cash flows
5
Notes to the condensed interim financial statements
6-9
 
 
 

 







 
 
 

 
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited)
 
   
Three months ended
March 31,
 
   
2015
   
2014
 
   
U.S. dollars in thousands
 
             
REVENUES:
           
Licensing revenue
    -       7,000  
Other revenue
    1       5  
TOTAL REVENUES
    1       7,005  
COST OF REVENUE
    -       1,050  
RESEARCH AND DEVELOPMENT EXPENSES, net
    3,829       1,736  
GENERAL AND ADMINISTRATIVE EXPENSES
    927       1,027  
OTHER INCOME
    -       100  
OPERATING INCOME (LOSS)
    (4,755 )     3,292  
FINANCIAL INCOME
    286       89  
FINANCIAL EXPENSES
    173       4  
FINANCIAL INCOME, net
    113       85  
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD
    (4,642 )     3,377  
                 
EARNINGS (LOSS) PER ORDINARY SHARE, (U.S. dollars):
               
Basic
    (0.05 )     0.04  
Diluted
    (0.05 )     0.04  
 
The accompanying notes are an integral part of these condensed financial statements.
 
 
2

 
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
 
   
March 31,
2015
   
December 31,
2014
 
   
U.S. dollars in thousands
 
             
CURRENT ASSETS
           
Cash and cash equivalents
    8,474       5,892  
Bank deposits
    24,058       17,053  
Prepaid expenses and receivables
    2,368       3,074  
      34,900       26,019  
NON-CURRENT ASSETS
               
Bank deposits
    75       76  
Fixed assets
    139       146  
Intangible assets
    6,115       2,615  
      6,329       2,837  
T O T A L ASSETS
    41,229       28,856  
                 
CURRENT LIABILITIES
               
Accounts payable and accrued expenses
    1,963       1,720  
Intangible assets payable, see note 3
    3,500       -  
      5,463       1,720  
                 
NON-CURRENT LIABILITIES
               
Derivative financial instruments
    1,877          
T O T A L LIABILITIES
    7,340       3,845  
                 
EQUITY:
            2,125  
Ordinary shares
    271       240  
Additional paid-in capital
    79,099       65,461  
Warrants
    1,057       1,528  
Accumulated deficit
    (46,538 )     (42,218 )
T O T A L EQUITY
    33,889       25,011  
T O T A L LIABILITIES AND EQUITY
    41,229       28,856  

The accompanying notes are an integral part of these condensed financial statements.

 
3

 
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
 
   
Ordinary shares
   
Additional paid-in capital
   
Warrants
   
Accumulated deficit
   
Total equity
 
   
U.S. dollars in thousands
 
BALANCE AT JANUARY 1, 2015
    240       65,461       1,528       (42,218 )     25,011  
CHANGES IN THE THREE MONTHS PERIOD ENDED MARCH 31, 2015:
                                       
Share-based compensation to employees and service providers
    -       -       -       322       322  
Issuance of ordinary shares, net of expenses
    31       13,167       -       -       13,198  
Warrants expiration
    -       471       (471 )     -       -  
Comprehensive loss
    -       -       -       (4,642 )     (4,642 )
BALANCE AT MARCH 31, 2015
    271       79,099       1,057       (46,538 )     33,889  
                                         
BALANCE AT JANUARY 1, 2014
    174       43,144       1,867       (33,260 )     11,925  
CHANGES IN THE THREE MONTHS PERIOD ENDED MARCH 31, 2014:
                                       
Share-based compensation to employees and service providers
    -       -       -       245       245  
Exercise of options and warrants into ordinary shares
    10       5,093       (639 )     -       4,464  
Issuance of ordinary shares and warrants, net of expenses
    55       15,927       1,057       -       17,039  
Warrants expiration
    -       694       (694 )     -       -  
Comprehensive income
    -       -       -       3,377       3,377  
BALANCE AT MARCH 31, 2014
    239       64,858       1,591       (29,638 )     37,050  


The accompanying notes are an integral part of these condensed financial statements.

 
4

 
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
 
   
Three months ended March 31,
 
   
2015
   
2014
 
   
U.S. dollars in thousands
 
             
OPERATING ACTIVITIES:
           
Comprehensive income (loss)
    (4,642 )     3,377  
Adjustments in respect of income and expenses not involving cash flow:
               
Share-based compensation to employees and service providers
    322       245  
Depreciation
    9       7  
Cost of out-licensing of intangible assets
    -       50  
Fair value gains on derivative financial instruments
    (248 )     (16 )
Fair value gains on financial assets at fair value through profit or loss
    -       1  
Revaluation of bank deposits
    (4 )     2  
Exchange differences relating to cash and cash equivalents
    167       (84 )
      246       205  
Changes in assets and liability items:
               
Decrease (increase) in prepaid expenses and receivables
    706       (716 )
Increase (decrease) in accounts payable and accrued expenses
    318       (1,190 )
      1,024       (1,906 )
Net cash provided by (used in) operating activities
    (3,372 )     1,676  
INVESTING ACTIVITIES:
               
Purchase of fixed assets
    (2 )     (25 )
Purchase of intangible assets
    (75 )     -  
Change in investment in current bank deposits
    (7,000 )     -  
Net cash used in investing activities
    (7,077 )     (25 )
FINANCING ACTIVITIES:
               
Proceeds from issuance of ordinary shares, warrants and derivative financial instruments, net of expenses
    13,198       19,364  
Exercise of warrants and options into ordinary shares, net of expenses
    -       4,464  
Net cash provided by financing activities
    13,198       23,828  
INCREASE IN CASH AND CASH EQUIVALENTS
    2,749       25,479  
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
    (167 )     84  
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
    5,892       11,851  
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD
    8,474       37,414  
Supplementary information on interest received in cash
    26       6  
Supplementary information on investing activities not involving cash flows - Purchase of intangible assets
    3,500       -  

The accompanying notes are an integral part of these condensed financial statements.
 
 
5

 
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED INTERIM FINANCIAL STATEMENTS
(Unaudited)

NOTE 1 - GENERAL:

 
a. 
General

RedHill Biopharma Ltd. (the “Company”) was incorporated in Israel on August 3, 2009 and is active in the pharmaceutical industry. The Company is focused primarily on the development and acquisition of late clinical-stage, proprietary therapeutic candidates for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers (the "Therapeutic Candidates"). Additionally, the Company's strategy is to commercialize these Therapeutic Candidates, possibly through cooperation with other pharmaceutical and biotechnology companies, and to acquire rights to additional therapeutic candidates.

In February 2011, the Company listed its securities on the Tel-Aviv Stock Exchange (“TASE”) and they have been traded on the TASE since then. Since December 2012, the Company's American Depositary Shares (“ADSs”) have been listed on the NASDAQ Capital Market (“NASDAQ”), each representing ten ordinary shares.

The Company's registered address is at 21 Ha'arba'a St, Tel-Aviv, Israel.

The Company is engaged in the research and development of most of its Therapeutic candidates and to date has out-licensed only one of its Therapeutic Candidates. Accordingly, there is no assurance that the Company’s business will generate positive cash flow. Through March 31, 2015, the Company has an accumulated deficit and its activities have been funded through public and private offerings of the Company's securities.

The Company plans to further fund its future operations through commercialization of its Therapeutic Candidates, out-licensing certain programs and raising additional capital. The Company's current cash resources are not sufficient to complete the research and development of all of the Company's therapeutic candidates. Management expects that the Company will incur more losses as it continues to focus its resources on advancing its Therapeutic Candidates based on a prioritized plan that will result in negative cash flows from operating activities. The Company believes its existing capital resources should be sufficient to fund its current and planned operations for at least the next 12 months.

If the Company is unable to commercialize or further out-license its remaining Therapeutic Candidates or obtain future financing, the Company may decide to delay, reduce the scope of, or eliminate one or more of its research, development programs or commercialization related to the Therapeutic Candidates, any of which may have a material adverse effect on the Company's business, financial condition and results of operations.

 
b. 
Approval of the condensed interim financial statements

These condensed interim financial statements were approved by the Board of Directors on April 29, 2015.

 
6

 
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED INTERIM FINANCIAL STATEMENTS (continued)
(Unaudited)
 
NOTE 2 - BASIS OF PREPARATION OF THE CONDENSED INTERIM FINANCIAL STATEMENTS:

 
a.
The Company's condensed interim financial statements for the three months ended March 31, 2015 and 2014 (the "Condensed Interim Financial Statements") have been prepared in accordance with International Accounting Standard IAS 34, “Interim Financial Reporting”. These Condensed Interim Financial Statements, which are unaudited, do not include all disclosures necessary for a complete statement of financial position, results of operations, and cash flow in conformity with generally accepted accounting principles. The Condensed Interim Financial Statements should be read in conjunction with the annual financial statements as of December 31, 2014 and for the year then ended and their accompanying notes, which have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as published by the International Accounting Standards Board (“IASB”). The results of operations for the three months ended March 31, 2015 are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.
 
The accounting policies applied in the preparation of the Condensed Interim Financial Statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2014.

 
b.
New IFRSs not yet in effect, and which the Company did not elect to adopt early, were listed in the 2014 annual financial statements.
 
NOTE 3 - AGREEMENT TO PURCHASE INTELLECTUAL PROPERTY:

On March 30, 2015 the Company entered into an agreement with a U.S.-based private company that granted the Company the exclusive worldwide development and commercialization rights for all indications to a therapeutic candidate targeting multiple inflammatory-GI and oncology disease indications. Under the terms of the agreement, the Company undertook to pay the U.S. company an upfront payment in the amount of $1.5 million and an additional amount of $2 million which will be paid on the earlier of (i) a specific date and (ii) reaching a specific development milestone. In addition, the Company undertook to pay up to $2 million in potential development milestone payments, and potential tiered royalties starting in the low double-digits. Such potential royalties are due until the later of (i) the expiration of the last to expire licensed patent that covers the product in the relevant country; and (ii) the expiration of regulatory exclusivity in the relevant country. As of March 31, 2015, the Company recognized an amount of $3.5 million as a current liability. In April 2015, the Company paid the U.S. company the initial amount of $1.3 million.
 
NOTE 4 - EQUITY:

 
a.
In February 2015, the Company completed an underwritten public offering in the U.S. of an aggregate of 1,150,000 ADSs at a price of $12.50 per ADS for gross proceeds to the Company of $14.4 million before underwriting discounts and commissions and other offering expenses. Net proceeds to the Company from the offering, following discounts, commissions and expenses amounting to $1.2 million, were approximately $13.2 million.

 
7

 
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED INTERIM FINANCIAL STATEMENTS (continued)
(Unaudited)
NOTE 4 – EQUITY (continued):

As a result of the offering, the Price Protection Right as defined in the annual financial statements as of December 31, 2014, provided by the Company to investors who participated in the January 2014 private placement, is no longer valid. The change in the fair value of the Price Protection Right of $542 thousand was recognized as financial income in the statement of comprehensive loss.

 
b. 
In January 2015, 2,558,440 unexercised warrants, issued by the Company in January 2013, expired along with any right or claim whatsoever of the holders.

NOTE 5 - FINANCIAL INSTRUMENTS:

 
a.
As of March 31, 2015 and December 31, 2014, the financial instruments of the Company presented at fair value are derivative financial instruments in the amounts of $1,877 thousand and $2,125 thousand, respectively. Those instruments are classified as level 3.

The following table presents the change in instruments measured at level 3 for the period ended March 31, 2015 and 2014:
 
   
Three months ended
March 31
 
   
2015
   
2014
 
   
Derivative financial instruments
 
   
U.S. dollars in thousands
 
Balance at beginning of the period
    2,125       -  
Proceeds received during the period
    -       2,325  
Amounts recognized in profit or loss
    (248 )     (1,100 )
Balance at the end of the period
    1,877       1,225  

The fair value of the above-mentioned derivative financial instruments that are not traded in an active market is determined by using valuation techniques. The Company uses its judgment to select a variety of methods and make assumptions that are mainly based on market conditions existing at the end of each reporting period.

The fair value of the warrants is computed using the Black and Scholes option pricing model. The fair value of the Price Protection Right is computed using a common valuation model, which takes into account specific scenarios. The fair value of the warrants as of March 31, 2015, is based on the price of an ordinary share on March 31, 2015 and based on the following key parameters: risk-free interest rate of 0.49% and an average standard deviation of 46.62%. The fair value of the warrants and Price Protection Right as of December 31, 2014, was computed based on the price of an ordinary share on December 31, 2014 and based on the following key parameters: risk-free interest rate of 0.12% - 0.7% and an average standard deviation of 44.92% - 61.70%.

 
b. 
The carrying amount of cash and cash equivalents, current and non-current bank deposits, receivables and account payables and accrued expenses approximate their fair values.
 
 
8

 
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED INTERIM FINANCIAL STATEMENTS (continued)
(Unaudited)
NOTE 6 – EARNINGS (LOSS) PER ORDINARY SHARE:

 
a.
Basic

The basic earnings (loss) per share is calculated by dividing the income (loss) by the weighted average number of ordinary shares in issue during the period.

   
Three months ended
March 31
 
   
2015
   
2014
 
Income (loss) (U.S. dollars in thousands)
    (4,642 )     3,377  
Weighted average number of ordinary shares outstanding during the period (in thousands)
    93,678       82,688  
Basic earnings (loss) per share (U.S. dollars)
    (0.05 )     0.04  

 
b. 
Diluted

The diluted loss per share for the three months period ended March 31, 2015 is identical to the basic loss per share since the effect of potential dilutive shares is anti-dilutive.

Diluted earnings (loss) per share is calculated by adjusting the weighted average number of ordinary shares outstanding to assume conversion of all dilutive potential ordinary shares, which is calculated using the treasury method. The Company has two categories of dilutive potential ordinary shares: warrants issued to investors and options issued to employees and service providers.

   
Three months ended
March 31
 
   
2015
   
2014
 
Income (loss) (U.S. dollars in thousands)
    (4,642 )     3,377  
Adjustment for financial income of warrants
    -       169  
Income (loss) used to determine diluted earnings (loss) per share
    (4,642 )     3,546  
Weighted average number of ordinary shares outstanding during the period (in thousands)
    93,678       82,688  
Adjustment for:
               
Warrants
    -       667  
Options
    -       7,622  
Weighted average number of ordinary shares for diluted earnings (loss) per share (in thousands)
    93,678       90,977  
Diluted earnings (loss) per share (U.S. dollars)
    (0.05 )     0.04  

 



 
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