RedHill Biopharma Ltd. (NASDAQ: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today reported its fourth quarter and full year 2022 financial results and operational highlights.
| Having extinguished all debt and significantly reduced cost-base, RedHill is now focused on late-stage pipeline advancement, in collaboration with U.S. and other governments, commercial growth and revenue-generating product acquisition opportunities Opaganib selected by NIH’s Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome (ARS) testing; FDA guidance provided on opaganib Animal Rule regulatory pathway, with Priority Review Voucher potential Positive UK MHRA scientific advisory meeting for RHB-102 (BEKINDA®) - UK Marketing Authorisation Application (MAA) for oncology support planned; Discussions with potential commercialization partners ongoing Talicia® delivers year-over-year prescription growth of 57% and first ever warranty program for a widespread community-treated condition1 established Cash balance of $36.1 million as of December 31, 20222; Reduced operating loss of $9.9 million in Q4/22, compared to $20.7 million in Q4/21; Following the sale of Movantik in exchange for all debt, the consolidated commercial organization will be transitioning to growing Talicia® and Aemcolo® sales and addressing the impact of gross-to-net allowances on revenues JOHANNESBURG, April 28, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today reported its fourth quarter and full year 2022 financial results and operational highlights.  Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “Having executed on our previously announced agreement with HCR, RedHill is now a debt-free company, with a significantly reduced cost-base, agreed HCR transition services revenues adding to existing revenue streams, and an exciting, U.S. Government supported, late-stage pipeline. We believe that RedHill has emerged from a challenging 2022 as a leaner company, well positioned to focus on potential growth. Our aim is now to maximize the sales of Talicia and Aemcolo, bring in new revenue-generating products and deliver on key late-stage pipeline catalysts. For a second quarter running, RedHill’s U.S. commercial operations, including Movantik sales, concluded with balanced cash flows in Q4/22 and continued Talicia’s growth curve, delivering year-over-year prescription growth of 57%. Indicative of our confidence in Talicia, and further supporting patient access, we are immensely proud to be the first pharmaceutical company to establish a warranty program for a widespread community-treated (non-hospital) condition, with RedHill committing to reimburse eligible patient out-of-pocket costs should Talicia not work1.” Mr. Ben-Asher continued: “The validation and acceleration of opaganib’s potential as a treatment for Acute Radiation Syndrome, following its selection for development by the NIH’s RNCP, along with applicability of the FDA Animal Rule regulatory pathway, is exciting. Opaganib has delivered promising efficacy signals, reported in several recently published preclinical studies, has a clinical trial safety database approaching 500 people and has a beneficial product profile, being an easy to administer and distribute oral pill with a five-year shelf-life. This positions opaganib to potentially address an important, high-focus market with an acute unmet medical need. The development of opaganib and RHB-107 for COVID-19 and other indications is also continuing under collaboration with U.S. Government agencies. The inherent value in our late-stage pipeline is further demonstrated by RHB-102’s positive UK MHRA pre-MAA scientific advice meeting, opening the door for a potential UK marketing approval submission and the identification of potential commercialization partners.” Financial results for the three months ended December 31, 2022 (Unaudited)3 Net Revenues for the fourth quarter of 2022 were $12.8 million, as compared to $22.1 million for the fourth quarter of 2021. Despite Talicia and Movantik prescription growth, increased gross-to-net allowances reduced net revenues. Cost of Revenues for the fourth quarter of 2022 was $8.6 million, as compared to $19.3 million for the fourth quarter of 2021. The difference is primarily attributable to a $9 million impairment related to Aemcolo recognized in the fourth quarter of 2021 and in line with the decrease in net revenues. Gross Profit for the fourth quarter of 2022 was $4.2 million, as compared to $2.7 million for the fourth quarter of 2021. The increase is primarily attributable to the recognized impairment of the Aemcolo intangible asset in the fourth quarter of 2021 as detailed above and partially offset by the decrease in net revenues in the fourth quarter of 2022. Research and Development Expenses for the fourth quarter of 2022 were $1.1 million, as compared to $5.9 million for the fourth quarter of 2021. The difference is attributable to the ongoing optimization of R&D costs and completion of clinical trials related to COVID. Selling, Marketing and General and Administrative Expenses for the fourth quarter of 2022 were $13.0 million, as compared to $17.6 million for the fourth quarter of 2021. The difference is mainly attributable to the successful ongoing cost-reduction measures. Operating Loss for the fourth quarter of 2022 was $9.9 million, as compared to $20.7 million for the fourth quarter of 2021, as detailed above. Net Cash Used in Operating Activities for the fourth quarter of 2022 was $2.4 million, as compared to $14.9 million for the fourth quarter of 2021. The difference is attributable to the reduction in operating expenses which are due to the ongoing cost-reduction measures. Net Cash Provided by Financing Activities for the fourth quarter of 2022 was $7.2 million comprised primarily of the public offering in the fourth quarter of 2022. Cash Balance as of December 31, 2022, was $36.1 million2. Financial results for the 12 months ended December 31, 20223 Net Revenues for the 12 months ended December 31, 2022, were $61.8 million, as compared to $85.8 million for the 12 months ended December 31, 2021. The reduction is attributable to increased gross-to-net allowances, mainly related to Movantik. Cost of Revenues for the 12 months ended December 31, 2022, was $33.3 million, as compared to $49.4 million for the 12 months ended December 31, 2021. The decrease is mainly attributable to the implementation of cost reduction measures and goes hand-in-hand with the reduction in revenues and also from the $9 million impairment related to Aemcolo recognized in the fourth quarter of 2021. Gross Profit for the 12 months ended December 31, 2022, was $28.5 million, as compared to $36.4 million for the 12 months ended December 31, 2021. The decrease mainly resulted from the decrease in revenues, enhanced due to the existence of the $9 million impairment related to Aemcolo recognized as cost of revenues in 2021. Research and Development Expenses for the 12 months ended December 31, 2022, were $7.3 million, as compared to $29.5 million for the 12 months ended December 31, 2021. The difference is attributable to the ongoing optimization of R&D costs and completion of clinical trials related to COVID. Selling, Marketing and General and Administrative Expenses for the 12 months ended December 31, 2022, were $64 million, as compared to $88 million for the 12 months ended December 31, 2021. The decrease is mainly attributable to various cost-control measures implemented during the second half of 2022, in particular the reduced salesforce. Operating Loss for the 12 months ended December 31, 2022, was $42.8 million, as compared to $81.1 million for the 12 months ended December 31, 2021. The difference is primarily attributable to a reduction in operating expenses as detailed above. Net Cash Used in Operating Activities for the 12 months ended December 31, 2022, was $29.2 million, as compared to $65.0 million for the 12 months ended December 31, 2021. The decrease is in line with the change in Operating Loss and is attributable to the completion of clinical trials related to COVID, as well as to the decrease in Selling, Marketing and General and Administrative Expenses that resulted from our cost reduction measures. Net Cash Provided by Financing Activities was $11.5 million for the year ended December 31, 2022, comprised primarily of proceeds from equity offerings offset by payments in respect of intangible assets. Business updates On April 11, 2023, the Company announced that it received confirmation from The Nasdaq Stock Market LLC (“Nasdaq”) that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing. To regain compliance with Nasdaq Listing Rule 5450(a)(1), the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on April 5, 2023. Listing compliance follows the Company’s implementation of a ratio change of the Company’s American Depositary Shares (“ADSs”) to its non-traded ordinary shares from the previous ratio of one (1) ADS representing ten (10) ordinary shares to a new ratio of one (1) ADS representing four hundred (400) ordinary shares, which the Company announced on March 16, 2023. The ratio change came into effect on March 23, 2023, and the Company’s ADSs continue to be traded on the Nasdaq Global Market (“Nasdaq”) under the symbol “RDHL” with a new CUSIP Number 757468202. On March 30, 2023, the Company announced that it had entered into a definitive agreement for a $6 million registered direct offering, and subsequently announced, on April 3, 2023, the closing of the offering for the purchase and sale of 1,500,000 of the Company’s ADSs (or ADS equivalents), series A warrants to purchase up to an aggregate of 1,500,000 ADSs and series B warrants to purchase up to an aggregate of 1,500,000 ADSs. The series A warrants have an exercise price of $4.75 per ADS, are exercisable immediately and have a term of five years following issuance, and the series B warrants have an exercise price of $4.00 per ADS, are exercisable immediately and have a term of nine months following issuance. On February 6, 2023, the Company announced the extinguishment of all RedHill’s debt obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement between RedHill’s U.S. subsidiary RedHill Biopharma Inc. and HealthCare Royalty (“HCR”) announced February 25, 2020, as amended, in exchange for the transfer of its rights in Movantik® (naloxegol) to Movantik Acquisition Co., an affiliate of HCR. HCR assumed substantially all post-closing liabilities, and RedHill retained substantially all pre-closing liabilities relating to Movantik. As part of the parties’ arrangement, and to ensure continuous patient care, RedHill will provide HCR with transition services for up to 12 months, paid for by HCR. HCR will retain security interests in certain RedHill assets until substantially all pre-closing liabilities relating to Movantik have been paid or other specific conditions are met. On December 6, 2022, the Company announced the closing of an underwritten public offering with gross proceeds to the Company of approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company. Adjusted following the March 23, 2023, ADS ratio change, the offering consisted of 800,000 units/pre-funded units consisting of (a) one ADS (or one pre-funded warrant to purchase one ADS in lieu thereof) and (b) one warrant to purchase one ADS at a price to the public of $10.0 per unit (or $9.96 per pre-funded unit after reducing $0.04 attributable to the exercise price of the pre-funded warrants). Discussions are ongoing for external non-dilutive funding for additional RHB-107 Phase 3 COVID-19 development, the out-licensing of RHB-204 in multiple territories, and the in-licensing of new revenue-generating products. Commercial Highlights Talicia® (omeprazole magnesium, amoxicillin and rifabutin)4
Aemcolo® (rifamycin)5
Movantik® (naloxegol)6
R&D Highlights Opaganib (ABC294640)7 - A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory indications, oncology and radioprotection. Nuclear Medical Countermeasures (Acute Radiation Syndrome):
COVID-19, pandemic preparedness and other:
RHB-107 (upamostat)8 – A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications.
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease9 (NTM)
RHB-102 (BEKINDA) – Oncology Support
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 adults10, and Aemcolo® for the treatment of travelers’ diarrhea in adults11. 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 broad-acting, host-directed, SK2 selective inhibitor targeting multiple indications, including for pandemic preparedness, with a Phase 2/3 program for hospitalized COVID-19 and a Phase 2 program in oncology and a nuclear radiation protection program ongoing; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed serine protease inhibitor with potential for pandemic preparedness, is in late-stage development for treatment of non-hospitalized symptomatic COVID-19, and is targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; and (v) RHB-102, with expected 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. 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 continued growth in prescriptions, the provision of transition services revenues related to the sale of Movantik, the addition of new revenue generating products, 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, the risk that the growth in prescriptions will not continue, that revenues from the provision of transition services to HCR pertaining to the sale of Movantik and the addition of new generating products will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will guarantee ongoing development or that any such development will be completed or successful; the risk that RHB-102 will not be submitted to the UK’s MHRA for approval in CINV/RINV, and if submitted may not be approved and if approved may not be successfully commercialized, as well as risks and uncertainties associated with; the risk that opaganib will not be shown to elevate ceramide and reduce sphingosine 1-phosphate (S1P) in cells, increasing the antitumor efficacy of radiation while concomitantly suppressing inflammatory damage to normal tissue, leading to the potential to suppress toxicity from unintended ionizing radiation (IR) exposure and improve patient response to chemoradiation in an oncology & radiological setting, 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, that the obligations of the term loan will not be met and that HCR will take steps to accelerate our payment obligations under our credit agreement with HCR, 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 April 28, 2023. 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 Category: Financials
1 Talicia Warranty Program eligibility: https://www.talicia.com/wp-content/uploads/2022/05/RHTC697-Cash-Pay-Warranty-Program-Leave-Behind.pdf 2 Including cash, cash equivalents, short-term bank deposits and restricted cash. 3 All financial highlights are approximate and are rounded to the nearest hundreds of thousands. 4 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. 5 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. 6 Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com. 7 Opaganib is an investigational new drug, not available for commercial distribution. 8 RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution. 9 RHB-204 is an investigational new drug, not available for commercial distribution. 10 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. 11 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. Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
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Company Codes: NASDAQ-SMALL:RDHL, Stuttgart:2RH.SG, Stuttgart:2RH0.SG | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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