Form 6-K RedHill Biopharma Ltd. For: Jul 26
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 July 2016
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 ☒ 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 condensed interim unaudited financial information for the six and three months period ended June 30, 2016".
Exhibit 2: Registrant’s condensed interim unaudited financial information as of June 30, 2016 and for the three months then ended.
This Form 6-K is incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities and Exchange Commission on May 2, 2013 (Registration No. 333-188286) and on October 29, 2015 (Registration No. 333-207654) and its Registration Statement on Form F-3 filed with the Securities and Exchange Commission on February 25, 2016 (Registration No. 333- 209702).
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.
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Date: July 26, 2016 |
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REDHILL BIOPHARMA LTD. Chief Executive Officer |
Exhibit 1
Press Release
RedHill Biopharma Reports 2016 Second Quarter
Financial Results
|
· |
RedHill maintains a strong and debt-free balance sheet with $47.7 million in cash at the end of the second quarter, allowing the Company to continue to diligently execute its three ongoing Phase III gastrointestinal disease programs in the U.S. as well as additional clinical programs |
|
· |
Recent key milestones include: |
|
· |
First patients dosed in the Phase II study with BEKINDA™ for diarrhea-predominant irritable bowel syndrome (IBS-D) |
|
· |
Positive Type B meeting with the FDA supporting the planned confirmatory Phase III study with RHB-105 for H. pylori infection |
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· |
Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering RHB-105 |
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· |
Positive final results from the Phase I study with YELIVA™ for advanced solid tumors, confirming that the study successfully met both primary and secondary endpoints |
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· |
Exclusive license agreement with Grupo JUSTE for the commercialization in Spain of RIZAPORT™ oral thin-film migraine drug |
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· |
Research collaboration with National Institutes of Health (NIH) for potential Ebola treatment |
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· |
Upcoming potential milestones include: |
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· |
Interim data and safety monitoring board (DSMB) analysis of the ongoing RHB-104 Phase III study for Crohn’s disease |
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· |
Final results from the ongoing Phase IIa study with RHB-104 for multiple sclerosis |
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· |
Initiation of three Phase I/II studies with YELIVA™ for additional oncology and inflammatory indications |
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· |
Top-line results from the ongoing Phase III study with BEKINDA™ for gastroenteritis |
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· |
Initiation of a confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection |
1
TEL-AVIV, Israel, July 26, 2016 RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer, today reported its financial results for the quarter ended June 30, 2016.
The Company will host a conference call on Tuesday, July 26, 2016, at 9:00 am EDT to review the financial results and business highlights, dial-in details are included below.
Financial highlights for the quarter ended June 30, 20161:
Research and Development Expenses for the second quarter of 2016 were $6.0 million, an increase of $0.9 million, compared to $5.1 million in the second quarter of 2015. Research and Development Expenses for the six months ended June 30, 2016 were $10.7 million, an increase of $1.8 million, compared to $8.9 million in the comparable period of 2015. The increase in 2016 resulted primarily from clinical trial costs related to the ongoing Phase III MAP US study with RHB-104 (Crohn's disease) and from preparations for several Phase I/II studies with YELIVA™ for multiple oncology, inflammatory and gastrointestinal indications.
General, Administrative and Business Development Expenses in the second quarter of 2016 were $1.2 million, an increase of $0.4 million, compared to $0.8 million in the second quarter of 2015. General, Administrative and Business Development Expenses for the six months ended June 30, 2016 were $2.4 million, an increase of $0.7 million, compared to $1.7 million in the comparable period of 2015. The increase was mainly due to enhanced business development activities.
Operating Loss in the second quarter of 2016 was $7.2 million, an increase of $1.3 million, compared to $5.9 million in the second quarter of 2015. Operating Loss for the six months ended June 30, 2016 were $13.1 million, an increase of $2.5 million, compared to $10.6 million in the comparable period of 2015. The increase was mainly due to increases in Research and Development Expenses, as detailed above.
Net Cash Used in Operating Activities in the second quarter of 2016 was $5.7 million, an increase of $1.0 million, compared to $4.7 million in the second quarter of 2015. Net Cash Used in Operating Activities for the six months ended June 30, 2016 was $10.7 million, an increase of $2.6 million, compared to $8.1 million in the comparable period of 2015. The increase mainly reflects the increase in Operating Loss, as detailed above.
Net Cash Used in Investment Activities in the second quarter of 2016 was $2.9 million, compared to Net Cashed Provided by Investment Activities of $3.5 million in the second quarter of 2015. Net Cash Used in Investment Activities for the six months ended June 30, 2016 was $7.5 million, an increase of $3.9 million, compared to $3.6 million in the comparable period of 2015. The increase in Net Cash Used in Investment Activities was mainly due to an increase in bank deposits and marketable securities in 2016.
Net Cash Provided by Financing Activities in the second quarter of 2016 was $0.1 million, compared to an immaterial amount in the second quarter of 2015. Net Cash Provided by Financing Activities for the six months ended June 30, 2016 was $0.1 million, compared to $13.2 million in the comparable period of 2015, which resulted mainly from the Company’s public offering in February 2015.
1. All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
2
Cash Balance2 as of June 30, 2016 was $47.7 million, a decrease of $10.4 million, compared to $58.4 million as of December 31, 2015. The decrease was a result of the ongoing operations, mainly related to research and development activities.
“We have achieved several significant clinical and operational milestones this quarter, while continuing to maintain our financial discipline,” said Mr. Micha Ben Chorin, RedHill’s CFO. “With a strong cash position of $47.7 million at the end of the second quarter we are well-positioned to advance our strategic and operational plans, including the establishment of commercial operations in the U.S. During the second quarter, we continued to actively advance our three Phase III-stage gastrointestinal programs. We are working towards several anticipated milestones, including interim DSMB analysis of the RHB-104 Phase III study for Crohn’s disease, final results from the Phase IIa study with RHB-104 for multiple sclerosis, initiation of a confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection and top-line results from the BEKINDA™ Phase III study for gastroenteritis. In the coming weeks, we expect to provide a mid-year business update that will highlight the status and timelines for RedHill’s main operations.”
Conference Call and Webcast Information:
The Company will host a conference call on Tuesday, July 26, 2016, at 9:00 am EDT to review the financial results and business highlights.
To participate in the conference call, please dial the following numbers 5-10 minutes prior to the start of the call: United States: +1-877-280-1254; International: +1-646-254-3388; and Israel: +972-3-763-0147. The access code for the call is 539724.
The conference call will be broadcasted live 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.
Recent operational highlights:
|
1. |
On April 11, 2016, RedHill announced that it had initiated a randomized, double-blind, placebo-controlled, 2-arm parallel group Phase II clinical study in the U.S. evaluating the safety and efficacy of BEKINDA™ 12 mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). The study is expected to be conducted in 12 clinical sites in the U.S. and to enroll 120 patients who will be randomized 60:40 to receive either BEKINDA™ 12 mg or a placebo, once daily, for a period of eight weeks. The primary endpoint for the study is the proportion of patients in each treatment group with response in stool consistency as compared to baseline, per U.S. Food and Drug Administration (FDA) guidance definition. Secondary endpoints include the proportion of patients in each treatment group who are pain responders and the proportion of patients in each treatment group who are responders to the combined endpoints of stool consistency and pain, per FDA guidance definition. RedHill further announced, on June 20, 2016, that the first patients in the Phase II study had been dosed. |
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2. |
On April 18, 2016, RedHill announced that it had concluded a positive Type B Meeting with the FDA regarding the path to marketing approval of RHB-105 and the planned confirmatory Phase III study |
2. Including cash, bank deposits and short-term investments
3
for the treatment of H. pylori infection. The FDA confirmed, subject to final minutes of the meeting, the planned two-arm, randomized, double-blind, active comparator design of the confirmatory Phase III study. Based on FDA feedback, and subject to successful completion, the planned confirmatory Phase III study, along with the successfully completed first Phase III study and data from a supportive PK program, are expected to support a U.S. New Drug Application (NDA) for RHB-105.
The FDA Type B meeting announcement followed the successful final results from the first Phase III clinical study with RHB-105 (the ERADICATE Hp study) reported in March 2016, confirming that the ERADICATE Hp study successfully met its primary endpoint of superiority over historical standard-of-care (SoC) eradication rate levels of 70%, with high statistical significance (p<0.001). The results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. RHB-105 has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as Priority Review status, potentially leading to a shorter review time by the FDA of a NDA, if filed. If approved, RHB-105 will have a total of 8 years of market exclusivity.
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3. |
On May 4, 2016, RedHill announced that the U.S. National Cancer Institute (NCI) has awarded the Medical University of South Carolina (MUSC) a $1.8 million grant to support a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers. One component of the studies includes a planned Phase II study with YELIVA™ (ABC294640) for the treatment of advanced hepatocellular carcinoma (HCC), the most common primary malignant cancer of the liver3. The Phase II study, planned to be initiated in the third quarter of 2016, will be conducted at MUSC and additional clinical sites and is intended to evaluate the efficacy and safety of YELIVA™ as a second-line monotherapy in patients with advanced HCC. The NCI grant covers a five-year period. The Phase II HCC study will be further supported by additional funding from RedHill, which acquired the exclusive worldwide rights to YELIVA™ from Apogee Biotechnology Corp. (Apogee). |
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4. |
On June 21, 2016, RedHill announced positive final results from the Phase I study with YELIVA™ in advanced solid tumors. The results confirmed that the study successfully met both its primary and secondary endpoints, demonstrating that YELIVA™ can be safely administered to cancer patients at doses that provide circulating drug levels that are predicted to have therapeutic activity, based on levels required in preclinical models. The study included the first-ever longitudinal analyses of plasma S1P levels as a potential pharmacodynamic biomarker for activity of a sphingolipid-targeted drug. Administration of YELIVA™ resulted in a rapid and pronounced decrease in S1P levels over the first 12 hours, with return to baseline at 24 hours, which is consistent with clearance of the drug. YELIVA™ was well tolerated over a prolonged period at doses inducing the expected pharmacodynamic effects. |
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5. |
On June 22, 2016, RedHill announced the publication of an article4 demonstrating that the triple combination of the RHB-104 active components provides excellent synergistic activity in the inhibition of mycobacterial growth, potentially leading to a new and effective treatment for Crohn’s disease associated with Mycobacterium avium subspecies paratuberculosis (MAP) infection. The article, entitled “RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn’s disease associated with Mycobacterium paratuberculosis” describes |
3. Gomma AI et al., Hepatocellular carcinoma: epidemiology, risk factors and pathogenesis, World J Gastroenterol, 2008 Jul 21; 14(27): 4300-8.
4. Alcedo KP, Thanigachalam S, Naser SA. RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn’s disease associated with Mycobacterium paratuberculosis, Gut Pathogens, 2016, 8:32.
4
a pre-clinical study intended to determine the efficacy of the RHB-104 active components (the antibiotics clarithromycin, clofazimine and rifabutin) against MAP strains isolated from the blood, tissue and milk of Crohn’s disease patients. The results of the study demonstrated that the RHB-104 active components, in their individual concentrations or in dual combinations, were not as effective against all microorganisms, compared to the triple combination at minimum inhibitory concentrations level.
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6. |
On July 5, 2016, RedHill and its co-development partner, IntelGenx Corp. (IntelGenx), announced the signing of an exclusive license agreement with Grupo JUSTE S.A.Q.F (Grupo JUSTE), for the commercialization of RIZAPORT™ oral thin-film for acute migraines. Under the terms of the agreement, RedHill granted Grupo JUSTE the exclusive rights to register and commercialize RIZAPORT™ in Spain and a right of first refusal for a predefined term for the territories of Belize, Carribean, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, the Middle East and Morocco. RedHill and IntelGenx are entitled to receive an upfront payment and additional milestone payments upon the achievement of certain predefined regulatory and commercial targets, as well as tiered royalties. Financial terms of the agreement were not disclosed. The initial term of the agreement is for ten years from the date of the first commercial sale and shall automatically renew for an additional two-year term. Commercial launch in Spain is expected to take place in the second half of 2017. |
|
7. |
On July 13, 2016, RedHill announced the signing of a research collaboration agreement with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), intended to evaluate RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease. The new research collaboration follows encouraging results from preliminary non-clinical studies conducted in conjunction with the NIAID using RedHill’s proprietary experimental therapy. If successful, this study is intended to provide supportive data for discussions with the FDA for potential use of the Animal Rule pathway for approval. Ebola virus disease is a severe and often fatal illness, which can cause severe hemorrhagic fever in humans and has a mortality rate ranging from 25% to 90%5. There is currently no FDA approved treatment for Ebola virus disease. |
|
8. |
On July 21, 2016, RedHill announced that it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering RHB-105. The patent application, entitled “Pharmaceutical Compositions For The Treatment Of Helicobacter Pylori” expands RedHill’s patent portfolio covering RHB-105 and is expected to be valid until 2034, once granted. The Company is currently prosecuting additional U.S. and international patent applications covering RHB-105. |
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is a biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of inflammatory and gastrointestinal diseases and cancer. RedHill’s current pipeline of proprietary products includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a 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 and an ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA™ (RHB-102) - a
5 World Health Organization (WHO), Fact sheet No° 103, January 2016.
5
once-daily oral pill formulation of ondansetron with an ongoing Phase III study in the U.S. for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA™ (ABC294640) – a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON® - a Phase II-stage first-in-class uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumors; (vii) RP101 - currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class 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 discussion with the FDA and marketing authorization received in Germany in October 2015; 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 Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (vii) 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; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) 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 25, 2016. 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.
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Company contact: |
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IR contact (U.S.): |
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Adi Frish |
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Marcy Nanus |
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Senior VP Business Development & Licensing |
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Senior Vice President |
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RedHill Biopharma |
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The Trout Group |
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+972-54-6543-112 |
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+1-646-378-2927 |
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6
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
|
|
|
Three months ended |
|
Six months ended |
|
||||
|
|
|
June 30, |
|
June 30, |
|
||||
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
U.S. dollars in thousands |
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
REVENUES |
|
1 |
|
1 |
|
1 |
|
2 |
|
|
RESEARCH AND DEVELOPMENT EXPENSES, net |
|
6,031 |
|
5,090 |
|
10,707 |
|
8,919 |
|
|
GENERAL, ADMINISTRATIVE AND BUSINESS DEVELOPMENT EXPENSES |
|
1,164 |
|
801 |
|
2,391 |
|
1,728 |
|
|
OPERATING LOSS |
|
7,194 |
|
5,890 |
|
13,097 |
|
10,645 |
|
|
FINANCIAL INCOME |
|
666 |
|
167 |
|
1,025 |
|
91 |
|
|
FINANCIAL EXPENSES |
|
24 |
|
873 |
|
4 |
|
684 |
|
|
FINANCIAL EXPENSES (INCOME), net |
|
(642) |
|
706 |
|
(1,021) |
|
593 |
|
|
LOSS AND COMPREHENSIVE LOSS |
|
6,552 |
|
6,596 |
|
12,076 |
|
11,238 |
|
|
LOSS PER ORDINARY SHARE (U.S. dollars): |
|
|
|
|
|
|
|
|
|
|
Basic |
|
0.05 |
|
0.07 |
|
0.09 |
|
0.12 |
|
|
Diluted |
|
0.06 |
|
0.07 |
|
0.10 |
|
0.12 |
|
7
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2016 |
|
2015 |
|
|
|
|
U.S. dollars in thousands |
|
||
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
3,424 |
|
21,516 |
|
|
Bank deposits |
|
36,766 |
|
36,622 |
|
|
Financial assets at fair value through profit or loss |
|
7,542 |
|
— |
|
|
Prepaid expenses and receivables |
|
2,180 |
|
2,372 |
|
|
|
|
49,912 |
|
60,510 |
|
|
NON-CURRENT ASSETS: |
|
|
|
|
|
|
Bank deposits |
|
137 |
|
134 |
|
|
Fixed assets |
|
148 |
|
124 |
|
|
Intangible assets |
|
6,060 |
|
6,060 |
|
|
|
|
6,345 |
|
6,318 |
|
|
TOTAL ASSETS |
|
56,257 |
|
66,828 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
4,755 |
|
3,514 |
|
|
Payable in respect of intangible asset purchase |
|
2,000 |
|
2,000 |
|
|
|
|
6,755 |
|
5,514 |
|
|
|
|
|
|
|
|
|
NON-CURRENT LIABILITIES - |
|
|
|
|
|
|
Derivative financial instruments |
|
522 |
|
1,237 |
|
|
TOTAL LIABILITIES |
|
7,277 |
|
6,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY: |
|
|
|
|
|
|
Ordinary shares |
|
344 |
|
343 |
|
|
Additional paid-in capital |
|
120,730 |
|
120,621 |
|
|
Warrants |
|
1,057 |
|
1,057 |
|
|
Accumulated deficit |
|
(73,151) |
|
(61,944) |
|
|
TOTAL EQUITY |
|
48,980 |
|
60,077 |
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND EQUITY |
|
56,257 |
|
66,828 |
|
8
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
Three months ended |
|
Six months ended |
|
||||
|
|
|
June 30, |
|
June 30, |
|
||||
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
U.S. dollars in thousands |
|
||||||
|
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
(6,552) |
|
(6,596) |
|
(12,076) |
|
(11,238) |
|
|
Adjustments in respect of income and expenses not involving cash flow: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation to employees and service providers |
|
495 |
|
294 |
|
869 |
|
616 |
|
|
Depreciation |
|
11 |
|
8 |
|
21 |
|
17 |
|
|
Unrealized losses (gains) on derivative financial instruments |
|
(514) |
|
869 |
|
(715) |
|
621 |
|
|
Fair value gains on financial assets at fair value through profit or loss |
|
(54) |
|
— |
|
(62) |
|
— |
|
|
Revaluation of bank deposits |
|
(89) |
|
14 |
|
(147) |
|
10 |
|
|
Exchange differences in respect of cash and cash equivalents |
|
41 |
|
(114) |
|
(41) |
|
53 |
|
|
|
|
(110) |
|
1,071 |
|
(75) |
|
1,317 |
|
|
Changes in assets and liability items: |
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in prepaid expenses and receivables |
|
(248) |
|
796 |
|
192 |
|
1,502 |
|
|
Increase in accounts payable and accrued expenses |
|
1,173 |
|
49 |
|
1,241 |
|
367 |
|
|
|
|
925 |
|
845 |
|
1,433 |
|
1,869 |
|
|
Net cash used in operating activities |
|
(5,737) |
|
(4,680) |
|
(10,718) |
|
(8,052) |
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
Purchase of fixed assets |
|
(16) |
|
(5) |
|
(45) |
|
(7) |
|
|
Purchase of intangible assets |
|
— |
|
(1,500) |
|
— |
|
(1,575) |
|
|
Change in investment in current bank deposits |
|
(2,000) |
|
5,000 |
|
— |
|
(2,000) |
|
|
Purchase of financial assets at fair value through profit or loss |
|
(908) |
|
— |
|
(7,480) |
|
— |
|
|
Net cash provided by (used in) investing activities |
|
(2,924) |
|
3,495 |
|
(7,525) |
|
(3,582) |
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of ordinary shares, net of expenses |
|
— |
|
— |
|
— |
|
13,198 |
|
|
Exercise of options into ordinary shares, net |
|
100 |
|
36 |
|
110 |
|
36 |
|
|
Net cash provided by financing activities |
|
100 |
|
36 |
|
110 |
|
13,234 |
|
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
(8,561) |
|
(1,149) |
|
(18,133) |
|
1,600 |
|
|
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS |
|
(41) |
|
114 |
|
41 |
|
(53) |
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
|
12,026 |
|
8,474 |
|
21,516 |
|
5,892 |
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
3,424 |
|
7,439 |
|
3,424 |
|
7,439 |
|
|
Supplementary information on interest received in cash |
|
4 |
|
54 |
|
15 |
|
80 |
|
|
Supplementary information on investing activities not involving cash flows - Purchase of intangible assets |
|
— |
|
— |
|
— |
|
2,000 |
|
9
Exhibit 2
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
JUNE 30, 2016
|
|
Page |
|
UNAUDITED FINANCIAL STATEMENTS AS OF JUNE 30, 2016 IN U.S. DOLLARS: |
|
|
|
|
| 2 | |
|
|
|
| 3 | |
|
|
|
|
4-5 |
|
|
|
|
| 6 | |
|
|
|
|
7-11 |
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
|
|
|
Three months ended |
|
Six months ended |
|
||||
|
|
|
June 30, |
|
June 30, |
|
||||
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
U.S. dollars in thousands |
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
REVENUES |
|
1 |
|
1 |
|
1 |
|
2 |
|
|
RESEARCH AND DEVELOPMENT EXPENSES, net |
|
6,031 |
|
5,090 |
|
10,707 |
|
8,919 |
|
|
GENERAL, ADMINISTRATIVE AND BUSINESS DEVELOPMENT EXPENSES |
|
1,164 |
|
801 |
|
2,391 |
|
1,728 |
|
|
OPERATING LOSS |
|
7,194 |
|
5,890 |
|
13,097 |
|
10,645 |
|
|
FINANCIAL INCOME |
|
666 |
|
167 |
|
1,025 |
|
91 |
|
|
FINANCIAL EXPENSES |
|
24 |
|
873 |
|
4 |
|
684 |
|
|
FINANCIAL EXPENSES (INCOME), net |
|
(642) |
|
706 |
|
(1,021) |
|
593 |
|
|
LOSS AND COMPREHENSIVE LOSS |
|
6,552 |
|
6,596 |
|
12,076 |
|
11,238 |
|
|
LOSS PER ORDINARY SHARE (U.S. dollars): |
|
|
|
|
|
|
|
|
|
|
Basic |
|
0.05 |
|
0.07 |
|
0.09 |
|
0.12 |
|
|
Diluted |
|
0.06 |
|
0.07 |
|
0.10 |
|
0.12 |
|
The accompanying notes are an integral part of these condensed financial statements.
2
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2016 |
|
2015 |
|
|
|
|
U.S. dollars in thousands |
|
||
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
3,424 |
|
21,516 |
|
|
Bank deposits |
|
36,766 |
|
36,622 |
|
|
Financial assets at fair value through profit or loss |
|
7,542 |
|
— |
|
|
Prepaid expenses and receivables |
|
2,180 |
|
2,372 |
|
|
|
|
49,912 |
|
60,510 |
|
|
NON-CURRENT ASSETS: |
|
|
|
|
|
|
Bank deposits |
|
137 |
|
134 |
|
|
Fixed assets |
|
148 |
|
124 |
|
|
Intangible assets |
|
6,060 |
|
6,060 |
|
|
|
|
6,345 |
|
6,318 |
|
|
TOTAL ASSETS |
|
56,257 |
|
66,828 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
4,755 |
|
3,514 |
|
|
Payable in respect of intangible asset purchase |
|
2,000 |
|
2,000 |
|
|
|
|
|
|
|
|
|
NON-CURRENT LIABILITIES: |
|
|
|
|
|
|
Derivative financial instruments |
|
522 |
|
1,237 |
|
|
TOTAL LIABILITIES |
|
7,277 |
|
6,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY: |
|
|
|
|
|
|
Ordinary shares |
|
344 |
|
343 |
|
|
Additional paid-in capital |
|
120,730 |
|
120,621 |
|
|
Warrants |
|
1,057 |
|
1,057 |
|
|
Accumulated deficit |
|
(73,151) |
|
(61,944) |
|
|
TOTAL EQUITY |
|
48,980 |
|
60,077 |
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND EQUITY |
|
56,257 |
|
66,828 |
|
The accompanying notes are an integral part of these condensed financial statements.
3
(Continued) – 1
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
|
|
|
Ordinary |
|
Additional |
|
|
|
Accumulated |
|
Total |
|
|
|
|
shares |
|
paid-in capital |
|
Warrants |
|
deficit |
|
equity |
|
|
|
|
U.S. dollars in thousands |
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE AT APRIL 1, 2016 |
|
343 |
|
120,631 |
|
1,057 |
|
(67,094) |
|
54,937 |
|
|
CHANGES IN THE THREE-MONTH PERIOD ENDED JUNE 30, 2016: |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation to employees and service providers |
|
— |
|
— |
|
— |
|
495 |
|
495 |
|
|
Exercise of options into ordinary shares |
|
1 |
|
99 |
|
— |
|
— |
|
100 |
|
|
Comprehensive loss |
|
— |
|
— |
|
— |
|
(6,552) |
|
(6,552) |
|
|
BALANCE AT JUNE 30, 2016 |
|
344 |
|
120,730 |
|
1,057 |
|
(73,151) |
|
48,980 |
|
|
BALANCE AT APRIL 1, 2015 |
|
271 |
|
79,099 |
|
1,057 |
|
(46,538) |
|
33,889 |
|
|
CHANGES IN THE THREE-MONTH PERIOD ENDED JUNE 30, 2015: |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation to employees and service providers |
|
|
|
— |
|
— |
|
294 |
|
294 |
|
|
Exercise of options into ordinary shares |
|
* |
|
36 |
|
— |
|
— |
|
36 |
|
|
Comprehensive loss |
|
— |
|
— |
|
— |
|
(6,596) |
|
(6,596) |
|
|
BALANCE AT JUNE 30, 2015 |
|
271 |
|
79,135 |
|
1,057 |
|
(52,840) |
|
27,623 |
|
*Represents amount less than $1 thousand.
The accompanying notes are an integral part of these condensed financial statements.
4
(Concluded) – 2
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
|
|
|
|
|
Additional |
|
|
|
|
|
|
|
|
|
|
Ordinary |
|
paid-in |
|
|
|
Accumulated |
|
Total |
|
|
|
|
shares |
|
capital |
|
Warrants |
|
deficit |
|
equity |
|
|
|
|
U.S. dollars in thousands |
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE AT JANUARY 1, 2016 |
|
343 |
|
120,621 |
|
1,057 |
|
(61,944) |
|
60,077 |
|
|
CHANGES IN THE SIX-MONTH PERIOD ENDED JUNE 30, 2016: |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation to employees and service providers |
|
— |
|
— |
|
— |
|
869 |
|
869 |
|
|
Exercise of options into ordinary shares |
|
1 |
|
109 |
|
— |
|
— |
|
110 |
|
|
Comprehensive loss |
|
— |
|
— |
|
— |
|
(12,076) |
|
(12,076) |
|
|
BALANCE AT JUNE 30, 2016 |
|
344 |
|
120,730 |
|
1,057 |
|
(73,151) |
|
48,980 |
|
|
BALANCE AT JANUARY 1, 2015 |
|
240 |
|
65,461 |
|
1,528 |
|
(42,218) |
|
25,011 |
|
|
CHANGES IN THE SIX-MONTH PERIOD ENDED JUNE 30, 2015 |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation to employees and service providers |
|
— |
|
— |
|
— |
|
616 |
|
616 |
|
|
Exercise of options into ordinary shares |
|
* |
|
36 |
|
— |
|
— |
|
36 |
|
|
Issuance of ordinary shares, net of expenses |
|
31 |
|
13,167 |
|
— |
|
— |
|
13,198 |
|
|
Warrants expiration |
|
|
|
471 |
|
(471) |
|
|
|
|
|
|
Comprehensive loss |
|
— |
|
— |
|
— |
|
(11,238) |
|
(11,238) |
|
|
BALANCE AT JUNE 30, 2015 |
|
271 |
|
79,135 |
|
1,057 |
|
(52,840) |
|
27,623 |
|
*Represents amount less than $1 thousand.
The accompanying notes are an integral part of these condensed financial statements.
5
REDHILL BIOPHARMA LTD.
CONDENSED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
Three months ended |
|
Six months ended |
|
||||
|
|
|
June 30, |
|
June 30, |
|
||||
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
U.S. dollars in thousands |
|
||||||
|
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
(6,552) |
|
(6,596) |
|
(12,076) |
|
(11,238) |
|
|
Adjustments in respect of income and expenses not involving cash flow: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation to employees and service providers |
|
495 |
|
294 |
|
869 |
|
616 |
|
|
Depreciation |
|
11 |
|
8 |
|
21 |
|
17 |
|
|
Unrealized losses (gains) on derivative financial instruments |
|
(514) |
|
869 |
|
(715) |
|
621 |
|
|
Fair value gains on financial assets at fair value through profit or loss |
|
(54) |
|
— |
|
(62) |
|
— |
|
|
Revaluation of bank deposits |
|
(89) |
|
14 |
|
(147) |
|
10 |
|
|
Exchange differences in respect of cash and cash equivalents |
|
41 |
|
(114) |
|
(41) |
|
53 |
|
|
|
|
(110) |
|
1,071 |
|
(75) |
|
1,317 |
|
|
Changes in assets and liability items: |
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in prepaid expenses and receivables |
|
(248) |
|
796 |
|
192 |
|
1,502 |
|
|
Increase in accounts payable and accrued expenses |
|
1,173 |
|
49 |
|
1,241 |
|
367 |
|
|
|
|
925 |
|
845 |
|
1,433 |
|
1,869 |
|
|
Net cash used in operating activities |
|
(5,737) |
|
(4,680) |
|
(10,718) |
|
(8,052) |
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
Purchase of fixed assets |
|
(16) |
|
(5) |
|
(45) |
|
(7) |
|
|
Purchase of intangible assets |
|
— |
|
(1,500) |
|
— |
|
(1,575) |
|
|
Change in investment in current bank deposits |
|
(2,000) |
|
5,000 |
|
— |
|
(2,000) |
|
|
Purchase of financial assets at fair value through profit or loss |
|
(908) |
|
— |
|
(7,480) |
|
— |
|
|
Net cash provided by (used in) investing activities |
|
(2,924) |
|
3,495 |
|
(7,525) |
|
(3,582) |
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of ordinary shares, net of expenses |
|
— |
|
— |
|
— |
|
13,198 |
|
|
Exercise of options into ordinary shares, net |
|
100 |
|
36 |
|
110 |
|
36 |
|
|
Net cash provided by financing activities |
|
100 |
|
36 |
|
110 |
|
13,234 |
|
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
(8,561) |
|
(1,149) |
|
(18,133) |
|
1,600 |
|
|
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS |
|
(41) |
|
114 |
|
41 |
|
(53) |
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
|
12,026 |
|
8,474 |
|
21,516 |
|
5,892 |
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
3,424 |
|
7,439 |
|
3,424 |
|
7,439 |
|
|
Supplementary information on interest received in cash |
|
4 |
|
54 |
|
15 |
|
80 |
|
|
Supplementary information on investing activities not involving cash flows - Purchase of intangible assets |
|
— |
|
— |
|
— |
|
2,000 |
|
The accompanying notes are an integral part of these condensed financial statements.
6
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED INTERIM FINANCIAL STATEMENTS (continued)
(Unaudited)
|
a. |
General |
RedHill Biopharma Ltd. (the "Company") was incorporated in Israel on August 3, 2009. The Company is focused primarily on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drug candidates for inflammatory and gastrointestinal diseases and cancer (the "Drug Candidates").
In February 2011, the Company listed its securities on the Tel-Aviv Stock Exchange (“TASE”). Since December 2012, the Company's American Depositary Shares (“ADSs”) have been listed on the NASDAQ Capital Market (“NASDAQ”).
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 Drug Candidates and to date has out-licensed only one of its Drug Candidates and granted rights in a specific territory for another Drug Candidate. Accordingly, there is no assurance that the Company’s business will generate positive cash flow. Through June 30, 2016, 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 Drug 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 Drug Candidates. Management expects that the Company will incur more losses as it continues to focus its resources on advancing its Drug 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 Drug Candidates or obtain future financing, the Company may be forced to delay, reduce the scope of, or eliminate one or more of its research and development programs or commercialization related to the Drug 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 July 25, 2016.
7
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 and six months ended June 30, 2016 and 2015 (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, 2015 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 and six months ended June 30, 2016 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, 2015.
|
b. |
New IFRSs not yet in effect, and which the Company did not elect to adopt early, were listed in the 2015 annual financial statements. |
NOTE 3- EQUITY:
During the six months period ended June 30, 2016, the Company received notifications of exercise with respect to options that had been issued to director and consultants of the Company. Accordingly, the Company issued 360,000 ordinary shares for approximately $110 thousand.
|
NOTE 4 |
SHARE-BASED PAYMENTS: |
|
a. |
On April 19, 2016, the Board of Directors of the Company granted 630,000 options to employees and consultants of the Company under the Company’s stock options plan. The fair value of the options grant on the date of grant was $427 thousand. |
Each option is exercisable into one ordinary share at an exercise price of $1.41 per share. The options will vest as follows: for employees and consultants of the Company who had provided services exceeding one year to the Company as of the grant date, the options will vest in 16 equal quarterly installments over a four-year period. For employees and consultants of the Company who had not provided services to the Company exceeding one year as of the grant date, the options will vest as follows: 1/4 of the options will vest one year following the grant
8
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED INTERIM FINANCIAL STATEMENTS (continued)
(Unaudited)
NOTE 4- SHARE-BASED PAYMENTS (continued):
date and the rest over the following three years in 12 equal quarterly installments.
The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company's ordinary share: $1.41, expected volatility: 53.1%, risk-free interest rate: 1.57% and expected useful life to exercise: 7 years.
The options will be exercisable, either in full or in part, from the vesting date until the end of 7 years from the date of grant.
|
b. |
On June 8, 2016, a general meeting of the Company’s shareholders resolved, subsequent to the approval of the Company’s Board of Directors on April 19, 2016, to allocate an aggregate of 1,500,000 options under the Company’s stock options plan to the Company's directors, including the Company's Chief Executive Officer. The fair value of the options granted to directors, on the date of approval by the general meeting of the Company’s shareholders, was $725 thousand. |
Each option is exercisable into one ordinary share at an exercise price of $1.28 per share. The options will vest as follows: for employees and consultants of the Company who had provided services exceeding one year to the Company as of the grant date, the options will vest in 16 equal quarterly installments over a four-year period. For employees and consultants of the Company who had not provided services to the Company exceeding one year as of the grant date, the options will vest as follows: 1/4 of the options will vest one year following the grant date and the rest over the following three years in 12 equal quarterly installments.
The fair value of the options was computed using the binomial model and the underlying data used was mainly the following: price of the Company's ordinary share: $1.08, expected volatility: 52.5%, risk-free interest rate: 1.51% and expected useful life to exercise: 7 years.
The options will be exercisable, either in full or in part, from the vesting date until the end of 7 years from the date of grant.
|
c. |
On June 8, 2016, a general meeting of the Company’s shareholders resolved, subsequent to the approval of the Company’s Board of Directors on April 19, 2016, to approve the acceleration of 150,000 unvested options to the estate of a former external director of the Company. Each option is exercisable into one ordinary share at an exercise price of $1.48 per share and will expire in November 2017. The allocated expenses, in the amount of $105 thousand were recorded directly to the statement of comprehensive loss under general and administrative expenses. |
9
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED INTERIM FINANCIAL STATEMENTS (continued)
(Unaudited)
NOTE 5- FINANCIAL INSTRUMENTS:
|
a. |
Fair value hierarchy |
The following table presents Company assets and liabilities measured at fair value:
|
|
|
Level 1 |
|
Level 3 |
|
Total |
|
|
|
|
U.S. dollars in thousands |
|
||||
|
June 30, 2016: |
|
|
|
|
|
|
|
|
Assets - |
|
|
|
|
|
|
|
|
Financial assets at fair value through profit or loss |
|
7,542 |
|
— |
|
7,542 |
|
|
Liabilities - |
|
|
|
|
|
|
|
|
Derivative financial instruments |
|
— |
|
522 |
|
522 |
|
|
December 31, 2015: |
|
|
|
|
|
|
|
|
Liabilities - |
|
|
|
|
|
|
|
|
Derivative financial instruments |
|
— |
|
1,237 |
|
1,237 |
|
|
b. |
Fair value measurements using significant unobservable input (Level 3) |
The following table presents the change in derivative financial liabilities measured at level 3 for the periods ended June 30, 2016 and 2015:
|
|
|
Three months ended |
|
Six months ended |
|
||||
|
|
|
June 30, |
|
June 30, |
|
||||
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
U.S. dollars in thousands |
|
||||||
|
Balance at beginning of the period |
|
1,036 |
|
1,877 |
|
1,237 |
|
2,125 |
|
|
Amounts recognized in profit or loss |
|
(514) |
|
869 |
|
(715) |
|
621 |
|
|
Balance at the end of the period |
|
522 |
|
2,746 |
|
522 |
|
2,746 |
|
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 warrants as of June 30, 2016, is based on the price of an ordinary share on June 30, 2016 and based on the following key parameters: risk-free interest rate of 0.36% and an average standard deviation of 48.14%. The fair value of the warrants as of December 31, 2015, was computed based on the price of an ordinary share on December 31, 2015 and based on the following key parameters: risk-free interest rate of 0.66% and an average standard deviation of 49.55%.
10
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED INTERIM FINANCIAL STATEMENTS (continued)
(Unaudited)
|
c. |
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. |
|
NOTE 6 - LOSS PER ORDINARY SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
a. Basic |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The basic loss per share is calculated by dividing the comprehensive loss by the weighted average number of ordinary shares in issue during the period. |
|||||||
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
||||
|
|
June 30, |
|
June 30, |
||||
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss (U.S. dollars in thousands) |
6,552 |
|
6,596 |
|
12,076 |
|
11,238 |
|
Weighted average number of ordinary shares outstanding during the period (in thousands) |
127,344 |
|
99,438 |
|
127,237 |
|
96,574 |
|
Basic loss per share (U.S. dollars) |
0.05 |
|
0.07 |
|
0.09 |
|
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
b. Diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The diluted loss per share for the three and six months period ended June 30, 2015 is identical to the basic loss per share since the effect of potential dilutive shares is anti-dilutive. Diluted 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. The effect of options issued to employees and service providers is anti-dilutive. |
|||||||
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
||||
|
|
June 30, |
|
June 30, |
||||
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
Comprehensive loss (U.S. dollars in thousands) |
6,552 |
|
6,596 |
|
12,076 |
|
11,238 |
|
Adjustment for financial income of warrants |
514 |
|
— |
|
715 |
|
— |
|
Loss used to determine diluted loss per share |
7,066 |
|
6,596 |
|
12,791 |
|
11,238 |
|
Weighted average number of ordinary shares outstanding during the period (in thousands) |
127,344 |
|
99,438 |
|
127,237 |
|
96,574 |
|
Adjustment for - Warrants |
171 |
|
— |
|
13 |
|
— |
|
Weighted average number of ordinary shares for diluted loss per share (in thousands) |
127,515 |
|
99,438 |
|
127,250 |
|
96,574 |
|
Diluted loss per share (U.S. dollars) |
0.06 |
|
0.07 |
|
0.10 |
|
0.12 |
|
|
|
|
|
|
|
|
|
11