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 August 2024
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:
This Form 6-K, including Exhibits 99.1 (solely with respect to “Financial results for the six months ended June 30, 2024 (Unaudited)”, “R&D and Commercial Highlights”, “Condensed Consolidated Interim Statements of Comprehensive Income (Loss)”, “Condensed Consolidated Interim Statements of Financial Position”, and “Condensed Consolidated Interim Statements of Cash Flows”) and 99.2 to this Report on Form 6-K, is 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), on January 11, 2022 (File No. 333-262099), on June 27, 2022 (File No. 333-265845), on June 29, 2023 (File No. 333-273001) and on June 20, 2024 (File No. 333-280327), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on March 30, 2021 (File No. 333-254848), on August 4, 2023 (File No. 333-273709), on October 13, 2023 (File No. 333-274957), as amended, and on August 9, 2024 (File No. 333-281417).
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”) |
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Date: August 29, 2024 | By: | /s/ Dror Ben-Asher |
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Name: | Dror Ben-Asher | ||
Title: | Chief Executive Officer |
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Press Release
RedHill Biopharma Announces First Half 2024 Business Highlights
A transformed RedHill:
· | Numerous potential catalysts |
· | Strengthened cash balance and control over our destiny following the Termination Agreement with Movantik Acquisition Co. and others: Executing on our plan to ensure a value-driven focus, operational efficiency and financial streamlining with a low cost-base |
· | U.S. government collaborations: Developing a promising, advancing and largely financially de-risked pipeline via U.S. government and other collaborations |
· | Addressing substantial and underserved indications: In oncology viral pandemic preparedness, nuclear/radioprotection, and obesity/diabetes |
· | Building value: In the lab and in the clinic through new studies, generating new intellectual property and publications and forging the right partnerships for our assets |
· | Streamlined U.S. commercial organization: Cost reduction measures resulted in a much smaller, more efficient and cost-effective organization while still maintaining a leadership position with Talicia® |
R&D and Commercial Highlights:
· | Opaganib: |
o | U.S. Army program for Ebola (believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease) |
o | Orphan drug designation granted by FDA for neuroblastoma |
o | Discussions ongoing for a potential externally-funded, mid-stage clinical study in an additional underserved oncology indication |
o | U.S. government-funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure |
o | Positive in vivo study results support potential of opaganib therapy in diabetes / obesity |
· | RHB-107: |
o | COVID-19: Enrollment ongoing in the U.S Department of Defense-supported 300-patient Phase 2 ACESO PROTECT platform trial for early |
COVID-19 outpatient treatment; enrollment estimated to be completed in the first half of 2025
o | U.S. Army-funded Ebola development program ongoing; RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir |
· | RHB-104: Newly published positive Phase 3 data demonstrated 64% increased efficacy with RHB-104 in Crohn's disease |
· | Talicia: The leading prescribed branded H. pylori therapy in the U.S., maintaining leadership position with a streamlined commercial team: |
o | Expected upcoming new H. pylori treatment guidelines may further enhance positioning and use |
o | Potential manufacturing developments aiming to open additional new markets underway |
o | Commercially launched in the UAE, triggering RedHill’s eligibility for potential milestone and royalty payments; Additional ex-US partnerships under discussions |
Financial highlights:
· | Cash balance of $8.2 million as of June 30, 20241; Net revenues for the first half of 2024 totaled $2.6 million. Talicia contributed $3.5 million, down from the first half of 2023 due to a 12% reduction in U.S. prescriptions, driven by employee terminations and other cost-cutting measures. Movantik recorded negative revenues of $0.9 million, primarily due to product returns. Excluding one-time items in the first half of 2023 related to the Movantik® divestiture, the operating loss and net loss improved by $9.9 million and $9.5 million, respectively, as these cost-cutting measures significantly reduced overall expenses |
· | Post-balance sheet date, RedHill signed a Global Termination Agreement with Movantik Acquisition Co. and others (the “Agreement”). The Agreement resulted in RedHill receiving $9.9 million in cash and gaining full control over $0.74 million in a restricted account, while assuming $12.2 million in liabilities, leading to a net balance sheet reduction of approximately $2.3 million. The Agreement ended all existing credit ties and removed the lien against Talicia |
TEL AVIV, Israel and RALEIGH, NC, August 29, 2024, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today reported its first half 2024 financial results and operational highlights, for the six months ended June 30, 2024.
“The first six months of this year have realized significant accomplishments, laying the groundwork for numerous potential upcoming catalysts. RedHill is now in possession of a promising, advancing and largely financially de-risked development pipeline designed to address substantial and underserved indications in oncology, viral pandemic preparedness, nuclear/radioprotection and diabetes and obesity-related disorders,” said Dror Ben-Asher, RedHill’s Chief Executive Officer. “There is no doubt that the last four years have been a challenge, primarily as a result of the pandemic’s negative impact on our commercial launches in the United States in the first half of 2020. However, we have been turning the ship around and I am immensely proud of our team that works tirelessly to create opportunities, deliver on plans and create value in the lab and in the clinic through new studies, generating additional patents and publications, identifying important new indications and forging the right partnerships for our assets, while maintaining a market leadership position with Talicia. We are executing on our plans to ensure a clear value-driven focus, operational efficiency and financial streamlining with a low cost-base, as well as a strengthened cash balance and solid control over all elements of our business.”
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Financial results for the six months ended June 30, 2024 (Unaudited)2
Net Revenues for the first half of 2024 were $2.6 million, compared to $5.4 million for the first half of 2023. Talicia net revenues were $3.5 million for the six months ended June 30, 2024, compared to $5.1 million for the six months ended June 30, 2023, mainly due to a 26% decrease in gross revenues and a 9% increase in Gross-to-Net deductions, mainly from increased Medicaid rebates. In the first half of 2024, $0.5 million of net revenues came from sales in the UAE. Talicia scripts in the U.S. in the first half of 2024 were down by approximately 12%, compared to the same period in 2023, mainly due to reduced promotion and marketing following employee terminations and other cost-cutting measures in the United States. These measures had a significant positive impact on reducing expenses, as detailed below.
Movantik had negative net revenues of $0.9 million in the first half of 2024, compared to negative net revenues of $0.1 million in the first half of 2023, mainly due to returns related to sales in the second and third quarters of 2020.
Gross Profit for the first half of 2024 was $1.2 million, compared to $3 million for the first half of 2023, in line with the decrease in Net Revenues as explained above and primarily attributable to the reduction in Talicia prescriptions following employee terminations and other cost-cutting measures.
Research and Development Expenses for the first half of 2024 were $0.7 million, as compared to $2.3 million for the first half of 2023. The decrease is mainly attributable to the costs from closing the RHB-204 clinical trial, which were recognized in the first half of 2023, and to ongoing cost-reduction measures.
Selling, Marketing, and General and Administrative Expenses for the first half of 2024 were $9 million, compared to $19 million for the first half of 2023. This decrease was primarily due to downsizing the U.S. workforce following the Movantik divestiture, leading to lower payroll and related expenses, and reduced sales force expenses.
Other Income – There was no other income for the first half of 2024, as compared to $43 million of other income for the first half of 2023. The other income recognized in the first half of 2023 was comprised of (i) $35.5 million from the divestiture of Movantik and (ii) $7.5 million from transitional services fees provided to the buyer of Movantik.
Operating Loss for the first half of 2024 was $8.4 million, compared to operating income of $24.7 million for the first half of 2023. The difference is primarily attributable to the changes resulting from the divestiture of Movantik the previous year, as detailed above. Excluding the other income from the Movantik transaction in 2023, the operating loss decreased by approximately $9.9 million, from an operating loss of $18.3 million for the first half of 2023, reflecting the positive operating impact of the cost-cutting measures.
Financial Income, net for the first half of 2024 was $5.4 million, compared to $26.3 million for the first half of 2023. In the first half of 2024, the income recognized was mainly attributable to warrants’ revaluation, offset by offerings’ expenses. In the first half of 2023, the income recognized was primarily attributable to a $20.6 million gain resulting from the extinguishment of the HCR Collateral Management LLC debt in exchange for the transfer of rights to Movantik.
Net Loss was $3.1 million for the first half of 2024, compared to net income of $51 million for the first half of 2023. This change was primarily attributable to the effects resulting from the sale of Movantik and ongoing cost-reduction measures, as detailed above. Excluding the other income and financial income from the Movantik transaction in 2023, the net loss decreased by approximately $9.5 million, from a net loss of $12.6 million for the first half of 2023, reflecting the positive net impact of the cost-cutting measures.
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Total Assets as of June 30, 2024 were $22 million, as compared to $23 million as of December 31, 2023. The decrease was primarily attributable to a reduction in the inventory balance due to sales, as well as a reduction in right-of-use assets, due to termination of car leases in the six months ended June 30, 2024.
Total Liabilities as of June 30, 2024 were $22 million, as compared to $21 million as of December 31, 2023. The increase is mainly due to higher allowance from deductions from revenues and increased warrant-related derivative liabilities, partially offset by lower accounts payable, accrued expenses and lease liabilities (due to the car leases’ termination).
Net Cash Used in Operating Activities for the six months ended June 30, 2024 was $6.2 million, compared to $17.8 million for the same period in 2023. The decrease in cash used was primarily due to settling pre-closing liabilities associated with Movantik and other operational activities in the six months ended June 30, 2023. Furthermore, this reduction is attributable to the cost-cutting measures mentioned above.
Net Cash Provided by Financing Activities for the six months ended June 30, 2024 was $7.9 million, comprised primarily of the net proceeds from securities offerings in the six months ended June 30, 2024. For the six months ended June 30, 2023, Net Cash Provided by Financing Activities was $4.8 million, comprised primarily of the net proceeds from securities offerings in the six months ended June 30, 2023, and the decrease in restricted cash, partially offset by the repayment of payables related to the purchase of intangible assets.
Cash Balance as of June 30, 2024 was $8.2 million1.
R&D and Commercial Highlights:
R&D:
RedHill’s pipeline is centered around opaganib3 & RHB-1074, two promising, potentially broad utility, novel, oral, host-directed small molecule drugs with demonstrated safety and efficacy profiles. Both candidates are advancing in predominantly U.S. government-supported, externally-funded programs, directed at multiple underserved indications with sizeable multi-billion-dollar market opportunities and potentially advantageous pathways to approval.
Between them, they are in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection (Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure).
Being (i) easy to administer and distribute and (ii) viral mutation-resistant, they are ideally suited for stockpiling strategies in the event of nuclear/chemical incidents and viral pandemic scenarios.
Opaganib:
· | U.S. Army program for Ebola. Opaganib is believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival and, separately, demonstrating a robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability |
· | Orphan drug designation granted by FDA for neuroblastoma (opaganib has several such designations in multiple indications, with three in oncology) |
· | Discussions ongoing for a potential externally-funded, late-stage study in an additional underserved oncology indication |
· | Positive in vivo study results support potential of opaganib therapy in diabetes / obesity-related disorders - a market projected to be worth approximately $100 billion within the next decade |
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· | U.S. government-funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for ARS and Sulfur Mustard exposure |
· | Late-stage COVID-19 program continues to address a multi-hundreds of millions of dollars market |
· | New opaganib publications: |
o | The Sphingolipid-Modulating Drug Opaganib Protects against Radiation-Induced Lung Inflammation and Fibrosis: Potential Uses as a Medical Countermeasure and in Cancer Radiotherapy. Publication showed that opaganib significantly improved long-term survival in an in vivo model of lung damage following exposure to ionizing radiation5 |
o | Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based Upon FiO2 Requirements. Publication showed that oral opaganib reduced mortality by 62% and delivered improved time to room air, and faster time to hospital discharge in a large group of 251 hospitalized, moderately severe COVID-19 patients requiring a Fraction of inspired Oxygen up to and including 60% (FiO2≤60%). The paper also indicates that due to the lack of treatment effect in patients requiring FiO2>60%, this may represent a threshold level for disease irreversibility (likely due to more severe COVID-19 lung disease) and be an important patient selection clinical biomarker, a key finding for future therapeutic strategies and studies6 |
· | New Chinese patents granted for opaganib: |
o | In combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response. Provides protection for opaganib's potential use in combination with a range of approved and in-development ICIs across a growing range of indications through 2040 |
o | As a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus); valid through 2035 |
RHB-107 (upamostat):
· | COVID-19: Enrollment ongoing in the U.S Department of Defense-supported 300-patient Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment. Enrollment is estimated to be completed in the first half of 2025 |
· | U.S. Army-funded Ebola development program ongoing; RHB-107 also demonstrated a robust synergistic effect in vitro when combined with remdesivir. Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies |
RHB-1047: Newly published positive Phase 3 data demonstrated 64% increased efficacy with RHB-104 in Crohn's disease
Commercial:
Talicia: The leading prescribed branded H. pylori therapy in the U.S., maintaining leadership position with a streamlined commercial team:
· | Expected upcoming new H. pylori treatment guidelines may further enhance positioning and use |
· | Potential manufacturing developments aiming to open additional new markets underway |
· | Now commercially launched in the UAE, triggering RedHill’s eligibility for potential milestone and royalty payments |
· | Two new U.S. patent grants covering Talicia as: |
o | A method for eradicating H. pylori regardless of BMI, valid until May 2042 |
o | Use as an all-in-one treatment of H. pylori infection, valid until 2034 |
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 Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults8, and Aemcolo®, for the treatment of travelers’ diarrhea in adults9. RedHill’s key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-
5
class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. 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, among others, statements regarding the progress of the research and development activities for opaganib and RHB-107, including (i) timing of opaganib’s development for Acute Radiation Syndrome, (ii) the potential market opportunity for opaganib and RHB-107, (iii) delays in the research and development activities for opaganib or RHB-107, including the ACESO PROTECT platform trial for early COVID-19 outpatient treatment, (iv) the risk that opaganib or RHB-107 are not found to be well-suited to counter nuclear/chemical exposure and viral pandemic scenarios, and (v) non-dilutive development funding from RHB-107 and its inclusion in a key platform study. 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: market and other conditions; the Company's ability to regain compliance with the Nasdaq Capital Market's minimum bid price requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and 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; 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,
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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; (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 April 8, 2024. 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
Category: Financials
1 Including cash, cash equivalents, short-term bank deposits and restricted cash.
2 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
3 Opaganib is an investigational new drug, not available for commercial distribution.
4 RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.
5 Maines LW, Keller SN, Smith RA, Green CL, Smith CD. The Sphingolipid-Modulating Drug Opaganib Protects against Radiation-Induced Lung Inflammation and Fibrosis: Potential Uses as a Medical Countermeasure and in Cancer Radiotherapy. International Journal of Molecular Sciences. 2024; 25(4):2322. https://doi.org/10.3390/ijms25042322
6 Neuenschwander FC, Barnett-Griness O, Piconi S, Maor Y, Sprinz E, Assy N, Khmelnitskiy O, Lomakin NV, Goloshchekin BM, Nahorecka E, et al. Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2 Requirements. Microorganisms. 2024; 12(9):1767. https://doi.org/10.3390/microorganisms12091767
7 RHB-104 is an investigational new drug, not available for commercial distribution.
8 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.
9 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.
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REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited)
| | Six Months Ended |
| ||
| | June 30, | | ||
|
| 2024 |
| 2023 | |
| | U.S. dollars in thousands | | ||
NET REVENUES | | 2,572 | | 5,395 | |
COST OF REVENUES | | 1,404 | | 2,418 | |
GROSS PROFIT | | 1,168 | | 2,977 | |
RESEARCH AND DEVELOPMENT EXPENSES | | 659 | | 2,331 | |
SELLING AND MARKETING EXPENSES | | 3,487 | | 9,632 | |
GENERAL AND ADMINISTRATIVE EXPENSES | | 5,470 | | 9,335 | |
OTHER INCOME | | — | | 42,993 | |
OPERATING INCOME (LOSS) | | (8,448) | | 24,672 | |
FINANCIAL INCOME | | 7,157 | | 28,677 | |
FINANCIAL EXPENSES | | 1,797 | | 2,347 | |
FINANCIAL INCOME, net | | 5,360 | | 26,330 | |
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD | | (3,088) | | 51,002 | |
EARNINGS (LOSS) PER ORDINARY SHARE, basic and diluted (U.S. dollars) | | (0.00) | | 0.04 | |
WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | | 11,760,458 | | 1,277,931 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
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REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
*See note 2b
The accompanying notes are an integral part of these condensed consolidated financial statements.
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REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
| | Six Months Ended |
| ||
| | June 30, | | ||
|
| 2024 |
| 2023 | |
| | U.S. dollars in thousands | | ||
OPERATING ACTIVITIES: | | | | | |
Comprehensive income (loss) | | (3,088) | | 51,002 | |
Adjustments in respect of income and expenses not involving cash flow: | | | | | |
Share-based compensation to employees and service providers | | 229 | | 849 | |
Depreciation | | 402 | | 1,055 | |
Amortization of intangible assets | | 16 | | 530 | |
Gains from the transfer of rights in Movantik® and extinguishment of debt obligations, (see below) | | — | | (56,082) | |
Gains from early termination of leases, net | | (23) | | (694) | |
Fair value gains on derivative financial instruments | | (7,108) | | (8,071) | |
Loss from modification of warrants terms as part of a new issuance | | — | | 1,084 | |
Issuance costs in respect of warrants | | 1,497 | | 922 | |
Exchange differences and revaluation of bank deposits | | (4) | | (13) | |
| | (4,991) | | (60,420) | |
Changes in assets and liability items: | | | | | |
Decrease in trade receivables | | 1,617 | | 31,618 | |
Decrease (increase) in prepaid expenses and other receivables | | (108) | | 1,337 | |
Decrease in inventories | | 585 | | 1,837 | |
Decrease in accounts payable | | (1,366) | | (1,118) | |
Decrease in accrued expenses and other liabilities | | (631) | | (10,545) | |
Increase (decrease) in allowance for deductions from revenue | | 1,797 | | (31,486) | |
| | 1,894 | | (8,357) | |
Net cash used in operating activities | | (6,185) | | (17,775) | |
INVESTING ACTIVITIES: | | | | | |
Purchase of fixed assets | | (1) | | (7) | |
Net cash used in investing activities | | (1) | | (7) | |
FINANCING ACTIVITIES: | | | | | |
Proceeds from issuance of ordinary shares and warrants, net of issuance costs | | 8,263 | | 5,097 | |
Repayment of payable in respect of intangible asset purchase | | — | | (6,555) | |
Decrease in restricted cash | | 51 | | 6,860 | |
Payment of principal with respect to lease liabilities | | (414) | | (589) | |
Net cash provided by financing activities | | 7,900 | | 4,813 | |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | | 1,714 | | (12,969) | |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | | (6) | | (3) | |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | | 5,569 | | 19,968 | |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD | | 7,277 | | 6,996 | |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | | 38 | | 123 | |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | | 28 | | 315 | |
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES: | | | | | |
Acquisition of right-of-use assets by means of lease liabilities | | 5 | | 224 | |
Decrease in lease liability (with corresponding decrease in right of use asset in amount of $170 in the six months ended June 30, 2024, and $4,117 in the six months ended June 30,2023) resulting from early termination of lease. | | 193 | | 4,811 | |
Transfer of rights in Movantik® and extinguishment of debt obligations: | | | | | |
Decrease in Intangible asset | | | | (59,503) | |
Decrease in Inventories | | | | (4,233) | |
Decrease in Payable in respect of Intangible asset | | | | 4,602 | |
Decrease in Borrowing | | | | 115,216 | |
Gains from the transfer of the rights in Movantik® and extinguishment of debt obligations | | | | 56,082 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
10
Exhibit 99.2
1
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
June 30, 2024
TABLE OF CONTENTS
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS OF JUNE 30, 2024, IN U.S. DOLLARS: | Page |
Condensed consolidated interim statements of comprehensive income (loss) | 3 |
Condensed consolidated interim statements of financial position | 4 |
Condensed consolidated interim statements of changes in equity | 5 |
6 | |
Notes to the condensed consolidated interim financial statements | 7-12 |
2
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited)
Six Months Ended | |||||
June 30, | |||||
| 2024 | 2023 | |||
U.S. dollars in thousands | |||||
NET REVENUES | 2,572 |
| 5,395 | ||
COST OF REVENUES | 1,404 | 2,418 | |||
GROSS PROFIT | 1,168 | 2,977 | |||
RESEARCH AND DEVELOPMENT EXPENSES | 659 | 2,331 | |||
SELLING AND MARKETING EXPENSES | 3,487 | 9,632 | |||
GENERAL AND ADMINISTRATIVE EXPENSES | 5,470 | 9,335 | |||
OTHER INCOME | — | 42,993 | |||
OPERATING INCOME (LOSS) | (8,448) | 24,672 | |||
FINANCIAL INCOME | 7,157 | 28,677 | |||
FINANCIAL EXPENSES | 1,797 | 2,347 | |||
FINANCIAL INCOME, net | 5,360 | 26,330 | |||
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD | (3,088) | 51,002 | |||
EARNINGS (LOSS) PER ORDINARY SHARE, basic and diluted (U.S. dollars) | (0.00) | 0.04 | |||
WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | 11,760,458 |
| 1,277,931 |
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)
*See note 2b
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 shares |
| Additional paid-in capital |
| Accumulated deficit |
| Total equity | |
U.S. dollars in thousands | ||||||||
BALANCE AT JANUARY 1, 2024 |
| 21,441 | 388,363 | (407,735) | 2,069 | |||
CHANGES IN THE SIX-MONTHS PERIOD ENDED JUNE 30, 2024: | ||||||||
Share-based compensation to employees and service providers | — | — | 766 | 766 | ||||
Issuance of ordinary shares, net of expenses | 13,135 | (12,821) | — | 314 | ||||
Issuance of ordinary shares for vested RSUs | 209 | (209) | — | — | ||||
Comprehensive loss | — | — | (3,088) | (3,088) | ||||
BALANCE AT JUNE 30, 2024 | 34,785 | 375,333 | (410,057) | 61 | ||||
BALANCE AT JANUARY 1, 2023 |
| 2,835 | 382,625 | (433,860) | (48,400) | |||
CHANGES IN THE SIX-MONTHS PERIOD ENDED JUNE 30, 2023: | ||||||||
Share-based compensation to employees and service providers | — |
| — |
| 849 |
| 849 | |
Issuance of ordinary shares, net of expenses |
| 1,761 | (1,741) | — | 20 | |||
Issuance of ordinary shares for vested RSUs | 24 | (24) | — | — | ||||
Comprehensive income |
| — |
| — |
| 51,002 |
| 51,002 |
BALANCE AT JUNE 30, 2023 |
| 4,620 |
| 380,860 |
| (382,009) |
| 3,471 |
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)
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
NOTE 1 - 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 American Depositary Shares (“ADSs”) were traded on the Nasdaq Capital Market from December 27, 2012, were listed on the Nasdaq Global Market (“Nasdaq”) from July 20, 2018, and have been again listed on the Nasdaq Capital Market since November 15, 2023. On March 23, 2023, the Company changed the ADS ratio from 1 ADS representing 10 ordinary shares to 1 ADS representing 400 ordinary shares. On August 20, 2024, after the condensed consolidated interim financial statements date, the Company changed the ADS to ordinary share ratio from 1 ADS representing 400 ordinary shares to 1 ADS representing 10,000 ordinary shares. The ADSs and per ADS amounts in these interim financial statements reflect the old ratio of 1 ADS to 400 ordinary shares.
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. Until February 1, 2023, the Company commercialized Movantik® in the U.S, for the treatment of opioid-induced constipation. See also note 15(6) in the annual financial statements as of December 31, 2023 regarding the transfer of the Company’s rights in Movantik® to HCR Collateral Management, LLC (“HCRM”) in exchange for all the Company’s debt obligations under the Credit Agreement with HCRM (see also note 10). The Company also continues to advance the development of part of its late-stage therapeutic candidates. |
3) | Through June 30, 2024, the Company has an accumulated deficit and negative working capital, and its activities have been funded primarily through public and private offerings of the Company’s securities and secured borrowing (now fully extinguished, see note 15(6) in the annual financial statements as of December 31, 2023(. 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 other non-dilutive financing. Furthermore, the Company is actively pursuing and in discussions with multiple parties regarding strategic business development transactions, including potential divestment of certain of the Company’s assets and/or its commercial operations, which the Company expects would provide it with additional capital, although there is no guarantee that the Company will complete such a transaction on favorable terms. The Company’s current cash resources are not sufficient to complete the research and development of any 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. Management believes that there is presently insufficient funding available to allow
7
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
the Company to fund its activities for a period exceeding one year from the date of this filing. These conditions and events indicate that a material uncertainty exists that may cast significant doubt (or raise substantial doubt as contemplated by PCAOB standards) about the Company’s ability to continue as a going concern.
The accompanying condensed consolidated interim financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
4) | In October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these condensed consolidated interim financial statements, the war in Israel is ongoing and continues to evolve. During six months ended of June 30,2024, the impact of this war on the Company results and financial condition was immaterial, but such impact may increase. |
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 August 28, 2024.
NOTE 2 - BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AND SIGNIFICANT ACCOUNTING POLICIES:
a. | BASIS OF PREPARATION |
The Company’s condensed consolidated interim financial statements for the six months ended June 30, 2024 (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, 2023, 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 six months ended June 30, 2024, are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.
b. | SIGNIFICANT ACCOUNTING POLICIES |
1) | General |
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, 2023, except for the reclassification of derivative financial instruments from non-current liabilities to current liabilities, as described in note 2b(2).
2) | New international financial reporting standards, amendments to standards and new interpretations |
Classification of Liabilities as Current or Non-Current (Amendment to IAS 1)
The narrow-scope amendments to IAS 1, “Presentation of Financial Statements,” clarify that liabilities are classified as either current or noncurrent, depending on the rights that exist at the end of the reporting period. Classification is unaffected by the entity’s expectations or events after the reporting date. The amendments also clarify what IAS 1 means when it refers to the settlement’ of a liability. The amendments may affect the classification of liabilities, particularly for entities that previously considered
8
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
management’s intentions to determine classification and for some liabilities that can be converted into equity. The Company adopted these amendments effective January 1, 2024. The impact on the Company’s financial statements of these amendments was the reclassification of the Company’s derivative financial instruments from non-current to current as of its effective date. The Company has retrospectively applied the amendments in these interim financial statements and, accordingly, has retrospectively adjusted the comparative balance sheet for December 31, 2023 to reclassify its warrant liabilities ($741 as of December 31, 2023) from non-current to current. Adoption of the amendments had no other impact on the Company’s financial statements.
IFRS 18, Presentation and Disclosure in the Financial Statements
This standard replaces the international accounting standard IAS 1, “Presentation of Financial Statements.” As part of the new disclosure requirements, companies will be required to present new defined subtotals in the statements of income, as follows: (1) operating profit and (2) profit before financing and tax. In addition, income statement items will be classified into three defined categories: operating, investment and financing. The standard also includes a requirement to provide a separate disclosure in the financial statements regarding the use of management-defined performance measures (“non-GAAP measures”), and specific instructions were added for the grouping and splitting of items in the financial statements and in the notes to the financial statements. IFRS 18 is effective for annual reporting periods beginning on or after January 1, 2027, with an option for early adoption.
NOTE 3 - SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD:
a. | On January 26, 2024, the Company issued 10,000,000 ADSs at a purchase price of $0.80 per ADS and warrants to purchase 10,000,000 ADSs at an exercise price of $1.00 per ADS. These warrants may be exercised in cash or on a cashless basis, are immediately exercisable, and expire in five years. The Company also issued to the placement agent warrants to purchase 600,000 ADSs under the same terms. The gross proceeds from the offering were $8 million, before deducting approximately $0.9 million in fees and expenses. |
The warrants were classified as a financial liability due to a net settlement provision. These derivatives were recognized and subsequently measured at fair value through profit or loss. Upon initial recognition the fair value of the warrants was adjusted to reflect the unrecognized day 1 loss. This unrecognized day 1 loss is amortized over the warrants’ contractual life. Consequently, $0.9 million of issuance costs allocated to the warrants, were included directly in the Consolidated Statements of Comprehensive Income (Loss). See also note 7.
b. | On March 21, 2024, the Annual General Meeting of shareholders approved the increase of the authorized share capital of the Company to NIS 400,000,000 divided into (i) 39,994,000,000 registered Ordinary Shares of NIS 0.01 par value each, and (ii) 6,000,000 preferred shares of NIS 0.01 par value each. |
c. | On April 3, 2024, the Company issued 2,144,487 ADSs at a purchase price of $0.58289 per ADS and warrants to purchase 2,144,487 ADSs at an exercise price of $0.75 per ADS. These warrants may be exercised in cash or on a cashless basis, are immediately exercisable and expire in five years. The gross proceeds from the offering were $1.25 million, before deducting offering expenses approximately $0.1 million in expesnses. |
The warrants were classified as a financial liability due to a net settlement provision. These derivatives were recognized and subsequently measured at fair value through profit or loss. The consideration, net of issue expenses, was allocated to the various issued instruments. Out of the gross consideration, $0.9 million was allocated to the warrants. The remainder of approximately $0.35 million was allocated to
9
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
equity. Issuance expenses allocated to the liability instruments were recorded directly in the Consolidated Statements of Comprehensive Income (Loss) and , while those allocated to equity were recorded against additional paid in capital. See also note 7.
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, 2024 |
| 8,087 |
| 2,567 | 10,654 | |
Increases | 4,565 | 103 | 4,668 | |||
Decreases (utilized) |
| (3,184) | (518) | (3,702) | ||
Adjustments | 423 | 408 | 831 | |||
As of June 30, 2024 |
| 9,891 |
| 2,560 | 12,451 | |
Rebates and patient discount programs | Product returns | Total | ||||
U.S. dollars in thousands | ||||||
As of January 1, 2023 |
| 46,636 |
| 1,234 | 47,870 | |
Increases | 16,918 | 759 | 17,677 | |||
Decreases (utilized) |
| (48,598) | (1,072) | (49,670) | ||
Adjustments | 910 | (403) | 507 | |||
As of June 30, 2023 |
| 15,866 | 518 | 16,384 |
NOTE 5 - SHARE-BASED PAYMENTS:
NOTE 6 - NET REVENUES:
Six Months Ended June 30, | ||||
| 2024 |
| 2023 | |
U.S dollars in thousands | ||||
Sales of products | 2,572 | 5,395 |
During the six months ended June 30, 2024, and June 30, 2023, the Company recorded contra-revenues of ($0.9) million and ($0.2) million for Movantik®, respectively, primarily due to returns following its divestiture on February 1, 2023 (see note 15(6) in the annual financial statements as of December 31, 2023). Correspondingly, net revenues from other products (mainly Talicia®) were $3.5 million in the first half of 2024, including $0.5
10
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
million from sales to Gaelan Medical Trade LLC, which has an exclusive license for Talicia® in the UAE (see note 15(7) in the annual financial statements as of December 31, 2023). In the first half of 2023, net revenues from other products (mainly Talicia®) were $5.6 million, all from U.S. sales.
NOTE 7 - FINANCIAL INSTRUMENTS:
a. | The Company’s derivative financial liability, represented by warrants, is measured at fair value and classified as level 3. Fair value adjustments are recognized in profit or loss as financial income or expenses. The following table presents the change in this level 3 derivative liability for the six months ended June 30, 2024, and June 30, 2023: |
Derivative financial instruments | |||
Six Months Ended June 30, | |||
2024 |
| 2023 | |
U.S. dollars in thousands | |||
Balance at beginning of the period | 741 | 2,623 | |
Initial recognition of financial liability | 9,860 | 7,083 | |
Initial recognition of unrecognized day 1 loss | (952) | — | |
Fair value adjustments recognized in profit or loss | (7,108) | (8,071) | |
Balance at end of the period | 2,541 | 1,635 |
The fair value of the warrants is computed using the Black-Scholes model. As of June 30,2024, it is based on the ADS price on that date and the following key parameters: risk-free interest rate of 4.35%-4.48% and volatility of 120.5%-133.6%. As of June 30,2023, it is based on the ADS price on that date and the following key parameters: risk-free interest rate of 4.17%-5.47% and volatility of 86.6%-99.5%.
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.
Adjusted EBITDA represents net loss before depreciation, amortization, and financial income (expenses), adjusted to exclude share-based compensation, gains from early termination of leases, and other income, which includes income from service provided to HCRM and gain from the sale of Movantik®.
The following table presents segment profitability and a reconciliation to the consolidated net income (loss) and comprehensive income (loss) for the periods indicated:
11
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 9 - EARNING (LOSS) PER SHARE:
The basic and diluted earnings (loss) per share are the same since the effect of all potentially diluted ordinary shares for all reporting periods is anti-dilutive.
NOTE 10 - EVENT SUBSEQUENT TO JUNE 30, 2024:
On July 15, 2024, the Company and RedHill Inc signed a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC, affiliates of HCRM (the “Global Termination Agreement”). This agreement terminates the Credit Agreement from February 23, 2020, which was amended on February 2, 2023, as part of the transaction where the rights to Movantik® were sold to HCRM in exchange for extinguishing all debt obligations under the Credit Agreement. The February 2023 agreement had placed a lien Talicia® and Aemcolo® assets and established an escrow account with restricted funds for Movantik® liabilities (for further details, see note 1(a)(2) above and notes 14(a), 15(4), 15(5), and 15(6) to the annual financial statements as of December 31, 2023).
The Global Termination Agreement terminates all existing credit ties, removing the aforementioned lien and restoring control over the restricted escrow funds. The Company received approximately $9.9 million in cash and gained full control over $0.7 million previously held in the restricted account. Under the Global Termination Agreement, the Company assumed certain liabilities related to Movantik® from the other parties and settled additional liabilities between the parties. This resulted in an increase of approximately $12.2 million in the Company's future obligations, reflecting these assumed and settled amounts.
12