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 June 2022
Commission File No.:001-35773
 
REDHILL BIOPHARMA LTD.
(Translation of registrant’s name into English)
 
21 Ha'arba'a Street, Tel Aviv, 6473921, 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 Announces Q1/22 Highlights: On Track for Positive Cash from Operations in H2/22”.
 
 
Exhibit 99.1 (solely with respect to “Financial results for the quarter ended March 31, 2022 (unaudited)”, “Liquidity and Capital Resources”, "Commercial Highlights", "R&D Highlights", "Condensed Consolidated Interim Statements of Comprehensive Loss", "Condensed Consolidated Interim Statements of Financial Position" and "Condensed Consolidated Interim Statements of Cash Flow") and Exhibit 99.2 to this Report on Form 6-K are hereby 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), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File No. 333-232776), on March 25, 2021 (File No. 333-254692), on May 3, 2021 (File No. 333-255710) and on January 11, 2022 (File No. 333-262099), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on July 24, 2019 (File No. 333-232777), on March 30, 2021 (File No. 333-254848) and on July 29, 2021 (File No. 333-258259).
 
2

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. 
 
 
REDHILL BIOPHARMA LTD.
 
 
(the "Registrant")
 
 
 
 
 
Date: June 23, 2022
By:
 /s/ Dror Ben-Asher 
 
 
Dror Ben-Asher 
 
 
Chief Executive Officer
 
 
3

 Exhibit 1

 
Press Release

RedHill Biopharma Announces Q1/22 Highlights:
On Track for Positive Cash from Operations in H2/22

 Targeting positive cash from operations to start during H2/221
--
Focus on earlier achievement of operational profitability thanks to a recently implemented
comprehensive cost reduction plan, with expected operational cost savings of approximately $50
million over the next 18 months
--
Continuous implementation of disciplined cost controls reduced Q1/22 cash used in operating
activities by more than 70% to approximately $4 million, compared to approximately $15 million
in Q4/21
--
Net revenues of $18.2 million in Q1/22; Cash balance2 of $45 million as of March 31, 2022
--
 Talicia® TRx up 12.8% over Q4/21 and Movantik® continues strong Q4/21 prescription
performance
--
Amendment improves key covenants in the HCR Credit Agreement
--
Given encouraging data to date, opaganib and RHB-107 COVID-19 Phase 3-stage programs
expected to be funded via external sources; Global and U.S. regulatory interactions ongoing
--
Management to host webcast today, at 08:30 a.m. EDT

TEL AVIV, Israel and RALEIGH, NC, June 23, 2022, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today reported its first quarter 2022 financial results and operational highlights, targeting positive cash from operations1 to start during H2/22. Recent implementation of a comprehensive cost reduction plan is expected to generate operational cost savings of approximately $50 million over the next 18 months.


1 Positive cash from operations before interest payments.
2 Including cash, cash equivalents, short-term bank deposits and restricted cash.


Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “To address the current market realities and operating landscape, RedHill is being decisive about controlling its own destiny and is highly focused on achieving earlier profitability, targeting positive cash from operations to start during H2/221. Our comprehensive cost reduction plan is expected to generate operational cost savings of approximately $50 million over the next 18 months. The majority of these savings result from an approximately one-third reduction of the U.S. commercial team workforce, returning to pre-pandemic levels, streamlined operational expenditure including selling, general and administrative (SG&A) expenses and refining the Company’s R&D strategy to rely mostly on external funding sources based on the promising clinical data generated to date. On behalf of RedHill and its Board of Directors, I would like to express my profound and respectful gratitude to the colleagues who are departing RedHill. We value and are extremely grateful for your immense contributions and dedication which enabled RedHill to build a first-class U.S. commercial organization and launch three innovative products that help patients in need. While difficult, the changes we have made as part of our cost reduction plan were necessary given the current realities.”

Mr. Ben-Asher continued: “Improved financial stability resulting from cost savings, a commercial basket including three FDA-approved proprietary drugs, continued prescription growth and healthy sales, improved managed care coverage and the amended credit agreement with HCR, positions RedHill for further growth. To that end, RedHill is in non-binding discussions to acquire a synergetic U.S. FDA-approved, patented GI drug currently generating dozens of millions of dollars, which, if materialized, will help expedite and increase cash generation.”

Micha Ben Chorin, Chief Financial Officer at RedHill, added: “RedHill’s commercial team has further strengthened Movantik®’s share of the growing PAMORA class to approximately 74%, and Talicia®’s approximately 13% quarterly growth further consolidates its position as the leading U.S. brand for H. pylori eradication. The Company’s disciplined cost control measures reduced Q1/22 cash used in operating activities by more than 70% to approximately $4 million, compared to approximately $15 million in Q4/21. Despite the challenging market conditions, RedHill is on its way to achieving company-wide positive cash from operations1 this year, and this, along with the envisaged growth drivers from the pipeline and potential acquisitions, could boost cash generation and further improve cash flow. We are confident that RedHill is well positioned for continuing growth.”
 
Mr. Ben-Asher further remarked: “Turning to R&D, in reliance of promising clinical and other data we generated to date, we expect external funding for much of our promising R&D programs, through grants, industry partnerships and participation in platform studies. COVID-19, included in a broader category of ‘pandemic preparedness’, remains an area of high interest and need for novel oral therapeutics such as RedHill’s candidates. Regulatory feedback on opaganib, supportive of a confirmatory study has provided a pathway to potential opaganib submissions for approval in COVID-19. Most recently, opaganib further exhibited its variant-agnostic credentials by demonstrating potent in vitro efficacy against Omicron, while also showing, in a separate study, potent in vitro inhibition of influenza A H1N1, adding to evidence of opaganib’s broader antiviral potential and its promising applicability to ‘pandemic preparedness’. Meanwhile, RedHill’s 2nd COVID-19 therapeutic candidate, RHB-107, successfully met the Part A study primary outcome measure for its Phase 2/3-stage study in non-hospitalized COVID-19, showing, among other promising data, a 100% reduction in hospitalization due to COVID-19. Discussions are ongoing regarding potential external funding through grants, platform studies and other public, private and industry partnerships to support the opaganib and RHB-107 programs, as well as our ongoing Phase 3 study with RHB-204 for NTM disease.”
2


Financial results for the quarter ended March 31, 2022 (Unaudited)3
 
Net Revenues for the first quarter of 2022 were $18.2 million, as compared to $22.1 million in the fourth quarter of 2021, the difference being attributable to typical cyclical trends in Movantik sales and increased gross to net deductions related mainly to increased formulary coverage.

Cost of Revenues for the first quarter of 2022 were $8.0 million, as compared to $19.3 million in the fourth quarter of 2021. The decrease was attributed to recognition of an approximately $9 million impairment related to the intangible asset of Aemcolo® for travelers’ diarrhea in the previous quarter.

Gross Profit for the first quarter of 2022 was $10.2 million, as compared to $2.7 million in the fourth quarter of 2021. The increase was attributed to the impairment recognized in the previous quarter, as detailed above.

Research and Development Expenses for the first quarter of 2022 were $3.1 million, as compared to $5.9 million in the fourth quarter of 2021. The decrease was attributed to the ongoing optimization of R&D costs and completion of elements of the opaganib and RHB-107 development programs.

Selling, Marketing and General and Administrative Expenses for the first quarter of 2022 were $20.4 million, as compared to $17.6 million in the fourth quarter of 2021. The increase was mainly attributed to a one-off positive adjustment in quarter four of 2021 and expenses related to professional services and other related expenses in the first quarter of 2022.

Operating Loss for the first quarter of 2022 was $13.2 million, as compared to $20.7 million in the fourth quarter of 2021. The decrease was mainly attributed to the impairment recognized in the previous quarter, as detailed above.

Net Cash Used in Operating Activities for the first quarter of 2022 was $4.2 million, as compared to $14.9 million in the fourth quarter of 2021. The decrease was mainly due to changes in working capital and continued implementation of cost-reduction measures.

Net Cash Used in Financing Activities for the first quarter of 2022 was $4.9 million, as compared to Net Cash Provided by Financing Activities of $17.6 million in the fourth quarter of 2021, comprised mostly from proceeds of equity offerings completed in the fourth quarter of 2021. The additional decrease of $5 million was due to a reduction of Movantik acquisition liabilities.


3 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
3


Liquidity and Capital Resources

Cash Balance1. as of March 31, 2022, was $45.0 million, as compared to $54.2 million as of December 31, 2021.

On June 17, 2022, RedHill Biopharma Inc. signed an amendment to the HCR Credit Agreement reducing the revenue covenant to $75.0 million for the next two quarters, with a 0.5% increase in interest.

The license of opaganib4 for COVID-19 by Kukbo for South Korea is expected to yield a $1.5 million upfront payment to RedHill and, in addition, up to $5.6 million in milestone payments plus royalties on net sales.

The license of Talicia for H. pylori by Gaelan Medical for the United Arab Emirates, with $2.0 million upfront payment received, is anticipated to yield additional milestones and royalties on net sales.

Discussions with additional potential partners, for both in- and out-licensing partnerships, are ongoing including for potential acquisitions of additional synergetic commercial products with strong cash generation potential.

Commercial Highlights

Movantik® (naloxegol)5
The Company’s focus and determination to drive both Movantik and the PAMORA class as a whole have delivered important results, with Movantik’s Q1/22 performance matching the record pace set in Q4/21. This represents an 8.6% increase in new prescriptions compared to Q1/21, more than doubling the already strong growth of the overall PAMORA class in the same period and contributing to a further increase in market share for Movantik, now up to almost 74% of the PAMORA class.

Nearly 92% of insurance plans provide access for Movantik – best-in-class coverage – and as of January 1, 2022, Movantik® has been approved for inclusion as a preferred and unrestricted brand on a major National Medicare Part D formulary serving more than 10 million Americans. Movantik’s total commercial coverage now extends to 151 million American patients’ lives and has grown to 46 million Medicare lives, with over 93% coverage of Medicare Part D lives.


4 Opaganib is an investigational new drug, not available for commercial distribution.
5 Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.
4


With best-in-class payer coverage, focused execution in the pain segment and continuing the PAMORA class market development, Movantik is well-positioned for continued growth in 2022 and beyond.

Talicia® (omeprazole magnesium, amoxicillin and rifabutin)6
Talicia reached new TRx heights in Q1/22, growing a further 12.8% compared to the previous record levels set in Q4/21. This growth represents an 80% increase in new prescriptions from Q1/21, further cementing Talicia’s position as the most prescribed branded H. pylori therapy in the U.S. Significant increase in prescription volume in March of this year, coupled with a growing prescriber base, improving payor coverage and continuing promotional focus is expected to result in further growth acceleration.

Medi-Cal, California's Medicaid Health Care program, which added Talicia last year to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required, expanded coverage to 14 million beneficiaries on January 1, 2022. Florida Medicaid coverage started in April and another large Part D plan coverage became effective earlier this quarter. The Company also expects a major new coverage win to initiate July 1, 2022. As of May 2022, total Talicia coverage stood at nearly 200 million American lives, equating to seven out of ten lives.

Outside of the U.S., in January 2022, the Company announced that it had entered into an exclusive license agreement with Gaelan Medical Trade LLC, a wholly owned subsidiary of the Ghassan Aboud Group (GAG), for Talicia in the United Arab Emirates (UAE). Under the terms of the agreement, RedHill received an upfront payment of $2 million and is eligible for additional milestone payments as well as tiered royalties up to mid-teens on net sales of Talicia in the UAE if marketing authorization is received and Talicia is commercialized. Gaelan Medical received the exclusive rights to Talicia in the UAE, as well as a right of first refusal in relation to Talicia in the Gulf Cooperation Council region (Saudi Arabia, Kuwait, Qatar, Bahrain and Oman) for a pre-determined period.

Aemcolo® (rifamycin)7
The Company continues to be ready for post-COVID-19 returning travel opportunities for Americans.

R&D Highlights

Opaganib (ABC294640)
COVID-19:
COVID-19, included in a broader category of ‘pandemic preparedness’, remains an area of high interest and need for novel oral therapeutics. Data from prespecified analyses of opaganib’s Phase 2/3 study (NCT04467840), announced in January and February 2022, demonstrated that opaganib improved viral RNA clearance, achieved faster time to recovery and reduced mortality in key subpopulations of moderate to severe hospitalized patients with COVID-19. Additionally, a post-hoc analysis identified a biomarker, the fraction of inspired oxygen (FiO2), to select patients that showed superior outcomes with opaganib vs. placebo. Opaganib also demonstrated potent in vitro efficacy against the Omicron SARS-CoV-2 variant and is expected to remain effective against sub-variants BA.2, XE and other emerging and future variants. Based on regulatory guidance, a positive confirmatory study constitutes the likely pathway to potential opaganib submissions for approval in the U.S., EU, and multiple other territories.


6 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
7 Aemcolo® (rifamycin) is indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
5


Data from the global Phase 2/3 study has now been published on MedRxiv and will also be the subject of a “Late-Breaker” oral presentation at the joint CDC / Task Force for Global Health-organized International Conference on Emerging Infectious Diseases, to be held in August.

On June 21, 2022, and adding to opaganib’s expanding patent suite, RedHill was granted an additional U.S. patent directed to a method for the treatment of COVID-19 in patients with moderate to severe COVID-19 related pneumonia using opaganib.

RedHill is pursuing multiple public and private external funding sources for our programs including grants in the U.S., UK and EU, government sponsored platform studies and industry partnerships. In March 2022, the Company announced that it had entered into an exclusive license agreement with Kukbo Co. Ltd., a South Korean corporation, for the exclusive rights to commercialize opaganib for the treatment of COVID-19 in South Korea. Under the terms of the agreement, RedHill is entitled to receive an upfront payment of $1.5 million and is eligible for $5.6 million in additional milestone payments, as well as low double-digit royalties on net sales of opaganib if marketing authorization is received and opaganib is commercialized.

Other indications under investigation:
Influenza A H1N1: Opaganib demonstrated potent in vitro inhibition of influenza A H1N1, at low concentrations and with no evidence of toxicity at these levels. The results were obtained in Normal Human Bronchial Epithelial Cells (NHBE) assay, the natural human target of the virus, making it a realistic model. These results add to previous data demonstrating antiviral activity in several in vitro and in vivo viral infection models including SARS-CoV-2, influenza and Ebola, providing further evidence of opaganib’s potential broad-spectrum antiviral effect. Discussions with NIH are ongoing regarding next steps for investigating opaganib’s broader antiviral potential and its promising applicability to ‘pandemic preparedness’.

Oncology:
The Company continues to advance opaganib’s development program in oncology with the cholangiocarcinoma (CCA) Phase 2 study analysis expected in Q3/2022

RHB-107 (upamostat)8
COVID-19:
In March 2022, the Company announced positive top-line results from Part A of the two- stage Phase 2/3 study of novel, once-daily, orally-administered, antiviral drug candidate, RHB-107. The study, evaluating RHB-107 for the treatment of non-hospitalized patients with symptomatic COVID-19 in the early course of the disease (NCT04723537), who do not require supplemental oxygen (the vast majority of COVID-19 patients) was predominantly conducted in the U.S. (60/61 patients) as well as South Africa.


8 RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.
6


Results showed that RHB-107 met the primary outcome measure, demonstrating a favorable safety and tolerability profile and showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized due to COVID-19 on the placebo-controlled arm (nominal p-value=0.0317). The study also showed an approximately 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only one patient in the RHB-107 treated group 2.4%, (1/41) versus 20% (4/20) of patients in the placebo-controlled arm. Further analysis of study data also showed a faster recovery from severe COVID-19 symptoms for patients in the RHB-107 arm, with a median of 3 days to recovery with RHB-107 vs. 8 days with placebo.

RHB 107’s unique human host-targeted, suggested antiviral mechanism is expected to act independently of viral spike protein mutations and remain effective against Omicron and sub-variants BA.2, XE and other emerging and future variants.

Next steps for the study are expected following ongoing discussions with regulators.

RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease9 
A U.S. Phase 3 study is ongoing in the U.S. to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium Complex (MAC) infection (NCT04616924). The waning of COVID-19 is expected to accelerate the advancement of the program

The study protocol provides for 6 months co-primary endpoint of sputum culture conversion (SCC) and clinical outcome (patient-reported outcomes - PRO) in a randomized placebo-controlled design, followed by open label active treatment with RHB-204 for 12 months from conversion.

RHB-204 has been granted Orphan Drug designation and QIDP status – providing for Fast Track and Priority Review and resulting in eligibility for 12 years post-approval market exclusivity.

Conference Call and Webcast Information:
 
The Company will host a conference call and webcast today, Thursday, June 23, 2022, at 8:30 a.m. EDT, during which it will present key highlights for the first quarter of 2022.

The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.


9 RHB-204 is an investigational new drug, not available for commercial distribution.
7


To participate in the conference call, please dial one of the following numbers up to 30 minutes before the scheduled start time: United States: +1-855-979-6654; International: +1-646-664-1960; and Israel: +972-72-258-7959; the access code for the call is: 647114.

To pre-register for the conference call, click here. 

About RedHill Biopharma             
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults5, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults6, and Aemcolo® for the treatment of travelers’ diarrhea in adults7. RedHill’s key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for hospitalized COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a Phase 3-stage study as treatment for non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.

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 and include statements regarding anticipated positive cash from operations before interest expected in 2022, the expected operational cost savings from the cost reduction plan and discussions regarding the acquisition of a synergetic U.S. FDA-approved GI drug. 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, the risk that the anticipated positive cash from operations before interest will not be positive in 2022, that the expected operational cost savings from the cost reduction plan will be lower than anticipated, that the acquisition of a synergetic U.S. FDA-approved GI drug will not materialize, that the obligations of the term loan are unable to be met, that we will not be successful in increasing sales of our commercial products, including due to market conditions, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type 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 and Talicia®; (v) the Company’s ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) 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; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) 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; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company’s industry; and (xv) the hiring and employment commencement date of executive managers. 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 March 17, 2022. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
 
Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Media contacts:
U.S. / UK: Amber Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com

8


REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)

   
Three Months Ended
 
   
March 31,
 
   
2022
   
2021
 
   
U.S. dollars in thousands
 
NET REVENUES
   
18,236
     
20,575
 
COST OF REVENUES
   
8,034
     
10,253
 
GROSS PROFIT
   
10,202
     
10,322
 
RESEARCH AND DEVELOPMENT EXPENSES
   
3,062
     
7,484
 
SELLING AND MARKETING EXPENSES
   
12,560
     
13,895
 
GENERAL AND ADMINISTRATIVE EXPENSES
   
7,818
     
7,095
 
OPERATING LOSS
   
13,238
     
18,152
 
FINANCIAL INCOME
   
10
     
42
 
FINANCIAL EXPENSES
   
3,909
     
4,753
 
FINANCIAL EXPENSES, net
   
3,899
     
4,711
 
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD
   
17,137
     
22,863
 
                 
LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars):
   
0.03
     
0.05
 
WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands)
   
525,186
     
429,603
 

9


REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)

   
March 31,
   
December 31,
 
   
2022
   
2021
 
   
U.S. dollars in thousands
 
CURRENT ASSETS:
           
Cash and cash equivalents
   
28,847
     
29,474
 
Bank deposits
   
17
     
8,530
 
Trade receivables
   
25,934
     
31,677
 
Prepaid expenses and other receivables
   
3,507
     
4,661
 
Inventory
   
14,272
     
14,810
 
     
72,577
     
89,152
 
NON-CURRENT ASSETS:
               
Restricted cash
   
16,165
     
16,169
 
Fixed assets
   
528
     
572
 
Right-of-use assets
   
7,736
     
3,651
 
Intangible assets
   
70,043
     
71,644
 
     
94,472
     
92,036
 
TOTAL ASSETS
   
167,049
     
181,188
 
                 
CURRENT LIABILITIES:
               
Accounts payable
   
5,706
     
11,664
 
Lease liabilities
   
1,431
     
1,618
 
Allowance for deductions from revenue
   
31,390
     
30,711
 
Accrued expenses and other current liabilities
   
24,151
     
20,896
 
Payable in respect of intangible assets purchase
   
11,223
     
16,581
 
     
73,901
     
81,470
 
NON-CURRENT LIABILITIES:
               
Borrowing
   
86,397
     
83,620
 
Payable in respect of intangible assets purchase
   
4,061
     
3,899
 
Lease liabilities
   
7,183
     
2,574
 
Royalty obligation
   
750
     
750
 
     
98,391
     
90,843
 
TOTAL LIABILITIES
   
172,292
     
172,313
 
                 
EQUITY:
               
Ordinary shares
   
1,506
     
1,495
 
Additional paid-in capital
   
375,948
     
375,246
 
Accumulated deficit
   
(382,697
)
   
(367,866
)
TOTAL EQUITY
   
(5,243
)
   
8,875
 
TOTAL LIABILITIES AND EQUITY
   
167,049
     
181,188
 

10


REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)

   
Three Months Ended
 
   
March 31,
 
   
2022
   
2021
 
   
U.S. dollars in thousands
 
OPERATING ACTIVITIES:
           
Comprehensive loss
   
(17,137
)
   
(22,863
)
Adjustments in respect of income and expenses not involving cash flow:
               
Share-based compensation to employees and service providers
   
2,306
     
872
 
Depreciation
   
537
     
492
 
Amortization and impairment of intangible assets
   
1,601
     
1,827
 
Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase
   
3,123
     
2,639
 
Fair value losses on financial assets at fair value through profit or loss
   
     
6
 
Exchange differences and revaluation of bank deposits
   
4
     
46
 
     
7,571
     
5,882
 
Changes in assets and liability items:
               
Decrease in trade receivables
   
5,743
     
5,349
 
Decrease in prepaid expenses and other receivables
   
1,154
     
1,428
 
Decrease (increase) in inventories
   
538
     
(2,744
)
Decrease in accounts payable
   
(5,958
)
   
(5,017
)
Increase in accrued expenses and other liabilities
   
3,255
     
1,364
 
Increase in allowance for deductions from revenue
   
679
     
4,334
 
     
5,411
     
4,714
 
Net cash used in operating activities
   
(4,155
)
   
(12,267
)
INVESTING ACTIVITIES:
               
Purchase of fixed assets
   
(13
)
   
(88
)
Change in investment in current bank deposits
   
8,500
     
 
Proceeds from sale of financial assets at fair value through profit or loss
   
     
475
 
Net cash provided by investing activities
   
8,487
     
387
 
FINANCING ACTIVITIES:
               
Proceeds from issuance of ordinary shares, net of issuance costs
   
713
     
57,941
 
Exercise of options into ordinary shares
   
     
3,227
 
Repayment of payable in respect of intangible asset purchase
   
(5,542
)
   
(2,125
)
Payment of principal with respect to lease liabilities
   
(115
)
   
(383
)
Net cash (used in) provided by financing activities
   
(4,944
)
   
58,660
 
 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
(612
)
   
46,780
 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
   
(15
)
   
(103
)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
   
29,474
     
29,295
 
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD
   
28,847
     
75,972
 
                 
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH
   
11
     
19
 
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH
   
772
     
1,990
 
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:
               
Acquisition of right-of-use assets by means of lease liabilities
   
4,767
     
 

11


Exhibit 2

REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
March 31, 2022
 

 
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
March 31,2022

TABLE OF CONTENTS

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS OF MARCH 31, 2022, IN U.S. DOLLARS:
Page
   
 3
   
 4
   
 5
   
 6
   
7-13

2

REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)

   
Three Months Ended
 
   
March 31,
 
   
2022
   
2021
 
   
U.S. dollars in thousands
 
NET REVENUES
   
18,236
     
20,575
 
COST OF REVENUES
   
8,034
     
10,253
 
GROSS PROFIT
   
10,202
     
10,322
 
RESEARCH AND DEVELOPMENT EXPENSES
   
3,062
     
7,484
 
SELLING AND MARKETING EXPENSES
   
12,560
     
13,895
 
GENERAL AND ADMINISTRATIVE EXPENSES
   
7,818
     
7,095
 
OPERATING LOSS
   
13,238
     
18,152
 
FINANCIAL INCOME
   
10
     
42
 
FINANCIAL EXPENSES
   
3,909
     
4,753
 
FINANCIAL EXPENSES, net
   
3,899
     
4,711
 
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD
   
17,137
     
22,863
 
                 
LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars):
   
0.03
     
0.05
 
WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands)
   
525,186
     
429,603
 

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

3

REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)

   
March 31,
   
December 31,
 
   
2022
   
2021
 
   
U.S. dollars in thousands
 
CURRENT ASSETS:
           
Cash and cash equivalents
   
28,847
     
29,474
 
Bank deposits
   
17
     
8,530
 
Trade receivables
   
25,934
     
31,677
 
Prepaid expenses and other receivables
   
3,507
     
4,661
 
Inventory
   
14,272
     
14,810
 
     
72,577
     
89,152
 
NON-CURRENT ASSETS:
               
Restricted cash
   
16,165
     
16,169
 
Fixed assets
   
528
     
572
 
Right-of-use assets
   
7,736
     
3,651
 
Intangible assets
   
70,043
     
71,644
 
     
94,472
     
92,036
 
TOTAL ASSETS
   
167,049
     
181,188
 
                 
CURRENT LIABILITIES:
               
Accounts payable
   
5,706
     
11,664
 
Lease liabilities
   
1,431
     
1,618
 
Allowance for deductions from revenue
   
31,390
     
30,711
 
Accrued expenses and other current liabilities
   
24,151
     
20,896
 
Payable in respect of intangible assets purchase
   
11,223
     
16,581
 
     
73,901
     
81,470
 
                 
NON-CURRENT LIABILITIES:
               
Borrowing
   
86,397
     
83,620
 
Payable in respect of intangible assets purchase
   
4,061
     
3,899
 
Lease liabilities
   
7,183
     
2,574
 
Royalty obligation
   
750
     
750
 
     
98,391
     
90,843
 
TOTAL LIABILITIES
   
172,292
     
172,313
 
                 
EQUITY:
               
Ordinary shares
   
1,506
     
1,495
 
Additional paid-in capital
   
375,948
     
375,246
 
Accumulated deficit
   
(382,697
)
   
(367,866
)
TOTAL EQUITY
   
(5,243
)
   
8,875
 
TOTAL LIABILITIES AND EQUITY
   
167,049
     
181,188
 

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

4

REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(Unaudited)

   
Ordinary
   
Additional
   
Accumulated
   
Total
 
   
shares
   
paid-in capital
   
deficit
   
equity
 
   
U.S. dollars in thousands
 
BALANCE AT JANUARY 1, 2022
   
1,495
     
375,246
     
(367,866
)
   
8,875
 
                                 
CHANGES IN THE THREE-MONTHS PERIOD ENDED MARCH 31, 2022:
                               
Share-based compensation to employees and service providers
   
     
     
2,306
     
2,306
 
Issuance of ordinary shares, net of expenses
   
11
     
702
     
     
713
 
Comprehensive loss
   
     
     
(17,137
)
   
(17,137
)
BALANCE AT MARCH 31, 2022
   
1,506
     
375,948
     
(382,697
)
   
(5,243
)
                                 
BALANCE AT JANUARY 1, 2021
   
1,054
     
293,144
     
(280,334
)
   
13,864
 
CHANGES IN THE THREE-MONTHS PERIOD ENDED MARCH 31, 2021:
                               
Share-based compensation to employees and service providers
   
     
     
872
     
872
 
Issuance of ordinary shares, net of expenses
   
242
     
57,699
     
     
57,941
 
Exercise of options into ordinary shares
   
13
     
3,214
             
3,227
 
Comprehensive loss
   
     
     
(22,863
)
   
(22,863
)
BALANCE AT MARCH 31,2021
   
1,309
     
354,057
     
(302,325
)
   
53,041
 

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

5

REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)

   
Three Months Ended
 
   
March 31,
 
   
2022
   
2021
 
   
U.S. dollars in thousands
 
OPERATING ACTIVITIES:
           
Comprehensive loss
   
(17,137
)
   
(22,863
)
Adjustments in respect of income and expenses not involving cash flow:
               
Share-based compensation to employees and service providers
   
2,306
     
872
 
Depreciation
   
537
     
492
 
Amortization and impairment of intangible assets
   
1,601
     
1,827
 
Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase
   
3,123
     
2,639
 
Fair value losses on financial assets at fair value through profit or loss
   
     
6
 
Exchange differences and revaluation of bank deposits
   
4
     
46
 
     
7,571
     
5,882
 
Changes in assets and liability items:
               
Decrease in trade receivables
   
5,743
     
5,349
 
Decrease in prepaid expenses and other receivables
   
1,154
     
1,428
 
Decrease (increase) in inventories
   
538
     
(2,744
)
Decrease in accounts payable
   
(5,958
)
   
(5,017
)
Increase in accrued expenses and other liabilities
   
3,255
     
1,364
 
Increase in allowance for deductions from revenue
   
679
     
4,334
 
     
5,411
     
4,714
 
Net cash used in operating activities
   
(4,155
)
   
(12,267
)
INVESTING ACTIVITIES:
               
Purchase of fixed assets
   
(13
)
   
(88
)
Change in investment in current bank deposits
   
8,500
     
 
Proceeds from sale of financial assets at fair value through profit or loss
   
     
475
 
Net cash provided by investing activities
   
8,487
     
387
 
FINANCING ACTIVITIES:
               
Proceeds from issuance of ordinary shares, net of issuance costs
   
713
     
57,941
 
Exercise of options into ordinary shares
   
     
3,227
 
Repayment of payable in respect of intangible asset purchase
   
(5,542
)
   
(2,125
)
Payment of principal with respect to lease liabilities
   
(115
)
   
(383
)
Net cash (used in) provided by financing activities
   
(4,944
)
   
58,660
 
 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
(612
)
   
46,780
 
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
   
(15
)
   
(103
)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
   
29,474
     
29,295
 
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD
   
28,847
     
75,972
 
                 
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH
   
11
     
19
 
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH
   
772
     
1,990
 
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:
               
Acquisition of right-of-use assets by means of lease liabilities
   
4,767
     
 

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

6

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
 
NOTE 1 - GENERAL:


a.
General


1)
RedHill Biopharma Ltd. (the “Company”), incorporated on August 3, 2009, together with its wholly-owned subsidiary, RedHill Biopharma Inc. (“RedHill Inc.”), incorporated in Delaware, U.S. on January 19, 2017, is a specialty biopharmaceutical company primarily focused on gastrointestinal (“GI”) diseases and infectious diseases.

The Company’s ordinary shares were traded on the Tel-Aviv Stock Exchange (“TASE”) from February 2011 to February 2020, after which the Company voluntarily delisted from trading on the TASE, effective February 13, 2020. The Company’s American Depositary Shares (“ADSs”) were traded on the Nasdaq Capital Market from December 27, 2012 and have been listed on the Nasdaq Global Market (“Nasdaq”) since July 20, 2018.

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


2)
Since the Company established its commercial presence in the U.S. in 2017, it has promoted or commercialized various GI-related products that were either developed internally or acquired through in-licensing agreements. As of the date of approval of these condensed consolidated interim financial statements, the Company commercializes in the U.S., mainly Talicia®, for the treatment of Helicobacter pylori infection in adults, the first product approved by the U.S. Food and Drug Administration (“FDA”) being developed primarily internally by the Company, and Movantik®, for the treatment of opioid-induced constipation.


3)
Through March 31, 2022, the Company has an accumulated deficit and its activities have been funded primarily through public and private offerings of the Company’s securities and borrowing. There is no assurance that the Company’s business will generate sustainable positive cash flows to fund its business.

The Company plans to further fund its future operations through commercialization and out-licensing of its therapeutic candidates, commercialization of in-licensed or acquired products and raising additional capital through equity or debt financing or through non-dilutive financing. The Company’s current cash resources are not sufficient to complete the research and development of all of its therapeutic candidates and to fully support its commercial operations until generation of sustainable positive cash flows. Management expects that the Company will incur additional losses as it continues to focus its resources on advancing the development of its therapeutic candidates, as well as advancing its commercial operations, 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, taking into consideration also certain covenants required under the Credit Agreement noted in note 15 to the annual financial statements as of December 31, 2021 (the “Credit Agreement”). See also note 9(b).

If the Company is unable to out-license, sell or commercialize its therapeutic candidates, generate sufficient and sustainable revenues from its commercial operations, 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 or commercialization programs, any of which may have a material adverse effect on the Company’s business, financial condition or results of operations.

The current COVID-19 pandemic has presented substantial public health and economic challenges around the world and specifically in the Company’s target markets in the U.S., affecting employees, patients, medical clinics, medical diagnosis, communities, and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted at this stage. The Company took actions designed to mitigate the potential impact of the COVID-19 pandemic on its business operations and to date, the COVID-19 pandemic has not caused significant disruptions to the supply chain and the Company has sufficient supply on hand to meet U.S. commercial demand and clinical study’s needs.

7

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
A number of the Company’s commercial activities have been impacted by the COVID-19 pandemic, including some launch sales and marketing activities for Talicia® for H. pylori infection and significant impact on sales of Aemcolo® for travelers’ diarrhea.

Although no major disruptions, other than manageable impact on its development and commercial activities, the Company continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including on its sales, expenses, supply chain, financial resources, and clinical trials.


b.
Approval of the condensed consolidated interim financial statements:

These condensed consolidated interim financial statements were approved by the Board of Directors (the "BoD") on June 22, 2022.

NOTE 2 - BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS:

The Company’s condensed consolidated interim financial statements for the three months ended March 31, 2022 (the "Condensed Consolidated Interim Financial Statements"), have been prepared in accordance with International Accounting Standard IAS 34, “Interim Financial Reporting”. These Condensed Consolidated Interim Financial Statements, that are unaudited, do not include all the information and disclosures that would otherwise be required in a complete set of annual financial statements and should be read in conjunction with the annual financial statements as of December 31, 2021, 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, 2022, are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.


a.
The accounting policies applied in the preparation of the Condensed Consolidated Interim Financial Statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2021, except for the following addition:

Revenues from licensing
 
The Company accounts for licenses of intellectual property (“IP”) rights and manufacturing and supply services as distinct performance obligations if the customer can benefit from the good or services either on its own or together with other resources that are readily available to the customer (i.e. – the good or service is capable of being distinct) and if the Company’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e. – the promise is distinct within the context of the contract).

If the promise to grant the license is distinct, the Company determines whether the nature of the promise in granting the license to the customer is to provide the customer with either a right to access the entity’s IP as it exists throughout the license period or a right to use the entity’s IP as it exists at the point in time at which the license is granted. Accordingly, revenue from a license providing a right of use to the Company’s is recognized at the point in time when control of the distinct license is transferred to the customer. Revenue from a license providing a right of access to the Company’s IP is recognized over the access period.

8

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
Variable consideration, such as sales-based royalties and milestones that are allocated to license of IP are recognized only when (or as) the later of the following occurs: (a) the subsequent sale occurs; and (b) the performance obligation to which some or all the sales-based royalty has been allocated has been satisfied (or partially satisfied).

Revenue from achieving additional milestones is recognized only when it is highly probable that a significant reversal of cumulative revenues will not occur, usually upon achievement of the specific milestone, in accordance with the relevant agreement.


b.
The following clarification to standards issued by the IASB has not yet been adopted by the Company:

IFRIC Agenda Decision on Demand Deposits with Restrictions on Use arising from a Contract with a Third Party (IAS 7 - Statement of Cash Flows)

In April 2022, the International Financial Reporting Interpretations Committee (IFRIC) issued an agenda decision clarifying that an entity should present a demand deposit with restrictions on use arising from a contract with a third party as cash and cash equivalents in the statements of financial position and cash flows, unless those restrictions change the nature of the deposit such that it no longer meets the definition of cash in IAS 7.

The Company is currently assessing the impact of this IFRIC agenda decision on its financial statements.

9

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 3 - SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD:
 

a.
During the three months ended March 31, 2022, the Company sold 333,533 ADSs under the “at-the-market” equity offering program (“ATM program”) at an average price of $2.07 per ADS, for aggregate net proceeds of approximately $0.7 million, net of an immaterial amount of issuance expenses.
 

b.
In March 2022, the Company entered into an exclusive license agreement with Kukbo Co. Ltd ("Kukbo") for oral opaganib for the treatment of COVID-19, in South Korea. Under the terms of the license agreement, which follows the strategic investment by Kukbo noted in note 18(c) to the annual financial statements as of December 31, 2021, RedHill is to receive an upfront payment of $1.5 million and is eligible for up to $5.6 million in milestone payments as well as low double-digit royalties on net sales of oral opaganib in South Korea. Kukbo will receive the exclusive rights to commercialize opaganib in South Korea for COVID-19.
 

c.
In October 2021, the Company entered into an exclusive license agreement (the “License Agreement”) with Gaelan Medical Trade LLC ("Gaelan") for Talicia in the United Arab Emirates (UAE). Under the terms of the License Agreement, the Company received in April 2022 an upfront payment of $2 million. In addition, the Company is eligible for additional milestone payments as well as tiered royalties up to mid-teens on net sales of Talicia in the UAE. Gaelan will receive the exclusive rights to commercialize Talicia in the UAE, as well as a right of first refusal to commercialize Talicia in the Gulf Cooperation Council region (Saudi Arabia, Kuwait, Qatar, Bahrain, and Oman) for a pre-determined period. Gaelan shall be responsible for obtaining and maintaining regulatory approvals, as well as to conduct any and all required clinical and other studies. In March 2022, the Company and Gaelan signed an amendment to the License Agreement, according to which Gaelan may sublicense or assign any of its rights or obligations under the License Agreement.
 
In connection with the License Agreement, the Company and Gaelan entered into a supply agreement, according to which, the Company will exclusively manufacture (by a third party CMO) and supply to Gaelan during the term of the agreement.
 
The Company accounted for the license of the Talicia IP rights and manufacturing and supply services as distinct performance obligations, mainly due to the manufacturing not being specialized or unique and can be manufactured by others (i.e. – the good or service is capable of being distinct), as well as due to that the License Agreement and the manufacturing and supply services do not significantly affect each other (i.e. – the promise is distinct within the context of the contract). During the three months ended March 31, 2022, the Company provided Gaelan substantially all the documentation which represents the right to use the Licensed IP, as well the paperwork relating to the IP itself and its regulatory documents. Accordingly, and since the manufacturing services are priced at their Standalone Selling Price, the Company recognized the $2 million upfront consideration as revenues in the Statement of Comprehensive Loss for the three months ended March 31, 2022.
 

d.
In March 2022, the Company entered into an operating lease agreement for the U.S. offices it uses. The agreement will expire on July 31, 2034. The projected yearly rental for the first four years expenses are approximately $400,000 per year and for the next 8 years are approximately $900,000 per year. The Company recognized right-of-use asset and lease liability of approximately $4.8 million. The weighted average lessee’s incremental annual borrowing rate applied to the lease liabilities was 9.9%.

10

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 4 - ALLOWANCE FOR DEDUCTIONS FROM REVENUES:

The following table shows the movement of the allowance for deductions from revenues:

   
Rebates and patient discount programs
   
Product returns
   
Total
 
   
U.S. dollars in thousands
 
As of January 1, 2022
   
29,742
     
969
     
30,711
 
Increases
   
19,773
     
1,903
     
21,676
 
Decreases (utilized)
   
(17,343
)
   
(946
)
   
(18,289
)
Adjustments
   
(1,789
)
   
(919
)
   
(2,708
)
As of March 31, 2022
   
30,383
     
1,007
     
31,390
 

   
Rebates and patient discount programs
   
Product returns
   
Total
 
   
U.S. dollars in thousands
 
As of January 1, 2021
   
16,380
     
1,963
     
18,343
 
Increases
   
17,804
     
460
     
18,264
 
Decreases (utilized)
   
(13,028
)
   
(243
)
   
(13,271
)
Adjustments
   
(659
)
   
-
     
(659
)
As of March 31, 2021
   
20,497
     
2,180
     
22,677
 

11

REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 5 - SHARE-BASED PAYMENTS:


a.
The following is information on options granted during the three months ended March 31, 2022:

   
Number of options granted
 
   
According to the Award Plan of the Company (1)
   
Exercise
price for 1
ADS ($)
   
Fair value of
options on date of
grant in U.S. dollars
in thousands (2)
 
             
Date of Grant
           
January 2022
   
5,000
     
2.45
     
7
 
March 2022
   
6,000
     
1.67
     
6
 
     
11,000
             
13
 


1)
The options will vest as follows: for directors, employees and consultants of the Company and the Company's subsidiary who had provided services exceeding one year as of the grant date, options will vest in 16 equal quarterly installments over a four-year period. For directors, employees and consultants of the Company and the Company's subsidiary who had not provided services 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 12 equal quarterly installments. During the contractual term, the options will be exercisable, either in full or in part, from the vesting date until the end of 10 years from the date of grant. 


2)
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 ADS: $1.67-2.45, expected volatility: 66.94%-67.21%, risk-free interest rate: 1.73%-1.78% and the expected term was derived based on the contractual term of the options, the expected exercise behavior and expected post-vesting forfeiture rates.


b.
During the three months ended March 31, 2022, the Board of Directors of the Company approved grants of 2,016,500 RSUs to employees and consultants of the Company under the Company’s Award plan. The RSUs vest as follows: 50% of RSUs will vest one year following grant and 50% will vest two years following grant. The fair value of the RSUs on the date of grant was $5.7 million.

In addition, the general meeting of the Company’s shareholders held on May 13, 2022 (the “May 2022 AGM”), subsequent to approval of the Company’s BoD, approved the grant of 140,000 RSUs under the Company’s Award plan to directors and to the Company's Chief Executive Officer in the same terms.   The fair value of these RSUs on the date of grant was $0.1 million.

NOTE 6 - NET REVENUES:
 
   
Three Months Ended March 31,
 
   
2022
   
2021
 
   
U.S dollars in thousands
 
Licensing revenues
   
2,000
     
 
Movantik revenues
   
14,614
     
18,898
 
Sales of other products
   
1,622
     
1,677
 
     
18,236
     
20,575
 

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REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 7 - FINANCIAL INSTRUMENTS:

The carrying amount of cash equivalents, bank deposits, restricted cash, receivables, account payables and accrued expenses approximate their fair value due to their short-term characteristics.

The fair value of the borrowing and Payable in respect of intangible assets purchase is approximately $98 million and $16 million as of March 31, 2022, respectively.

NOTE 8 - SEGMENT INFORMATION:

The Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”). The CODM allocates resources and assesses the Company’s performance based on the following segmentation: Commercial Operations and Research & Development.

Effective December 31, 2021, the Company changed its operating segments to reflect the manner in which the Company's CODM reviews and assesses performance. Accordingly, the Company reports on revenue and segment Adjusted EBITDA. Disclosures regarding the Company’s reportable segments for prior periods have been adjusted to conform to the current period presentation. Adjusted EBITDA represents net loss before depreciation, amortization, and financial expenses (income), adjusted to exclude share-based compensation.

The following table presents segment profitability and a reconciliation to the consolidated net loss and comprehensive loss for the periods indicated:

   
Three Months Ended March 31,
 
   
2022
   
2021
 
   
U.S. dollars in thousands
 
Commercial Operations Segment Adjusted EBITDA
   
(5,881
)
   
(5,011
)
Research And Development Adjusted EBITDA
   
(2,913
)
   
(9,950
)
Financial expenses (income), net
   
3,899
     
4,711
 
Share-based compensation to employees and service providers
   
2,306
     
872
 
Depreciation
   
537
     
492
 
Amortization and impairment of intangible assets
   
1,601
     
1,827
 
Consolidated Comprehensive loss
   
17,137
     
22,863
 

Except for $2 million licensing revenues reported in the three months ended March 31, 2022, which are allocated to the Research and Development segment, all of the Company’s revenues are allocated to the Commercial Operations segment.

 NOTE 9 - EVENT SUBSEQUENT TO MARCH 31, 2022:


a.
In May 2022, the Company entered into a definitive agreement with a single investor. In accordance with the agreement, the Company issued to the investor 10,563,380 ADSs (or ADS equivalents), as well as granted unregistered private warrants to purchase up to 13,204,225 ADSs, for a total net consideration of $14.3 million.

The warrants have an exercise price of $1.48 per ADS, are exercisable six months after the issuance date, and have a term of five and one-half years. The warrants may be exercised either for cash or on a cashless basis.


b.
On June 17, 2022, RedHill Inc. signed an amendment to the Credit Agreement. Under the Amendment, RedHill Inc. shall be required to maintain minimum net sales of $75 million for the trailing four fiscal quarter periods ending June 30, 2022, and September 30, 2022, and $90 million each fiscal quarter thereafter. Redhill Inc. shall also be required to maintain minimum net sales of $14 million for Movantik® each fiscal quarter starting the fiscal quarter ending June 30, 2022. The Amendment further sets the interest on the outstanding term loan for the quarters ending June 30, 2022, and September 30, 2022, at 3-month LIBOR rate (“LIBOR”), subject to a 1.75% floor rate, plus 7.2% fixed rate, which will be decreased to 6.7% thereafter.

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