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RedHill Announces New H. pylori and COVID-19 Data Publication and Presentations at Leading Upcoming Scientific Conferences
https://finance.yahoo.com/news/redhill-announces-h-pylori-covid-120000893.html
Talicia® - World Gastro 2022 congress (August 17-18): RedHill invited to give prestigious oral presentation of important data detailing high eradication rates across body mass index (BMI) groups with Talicia, the U.S.'s leading brand for Helicobacter pylori (H. pylori) eradication treatment - invitation sent to researchers with significant recently published clinical findings
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Opaganib for COVID-19 – Suggested host-directed mechanism of action described in Drug Design, Development and Therapy journal: Multi-faceted potential to: Inhibit spike protein-ACE2 binding, Akt signaling and endocytosis, induce autophagy and apoptosis, and disrupt the viral replication-transcription complex (RTC) through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS) - supports hypothesis of broad antiviral effect and attenuation of multi-organ dysfunction in COVID-19 patients
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Opaganib for COVID-19 - 2nd ARDS Drug Development Summit (July 13-15): Presenting new COVID-19 biomarker methodology utilizing baseline Fraction of Inspired Oxygen (FiO2) as a new disease severity classification paradigm - Phase 2/3 data demonstrating a 62% reduction in mortality in opaganib-treated patients requiring FiO2 up to 60% to be presented
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Opaganib and RHB-107 (upamostat) for COVID-19 - International Conference on Emerging Infectious Diseases (ICEID, August 7-10): Presenting promising efficacy and safety data for RedHill's novel, oral, variant-agnostic investigational COVID-19 therapies, at ICEID, the premier infectious disease conference hosted by the CDC and the Global Task Force for Health
RALEIGH, N.C. and TEL AVIV, Israel, July 12, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the upcoming presentation of new Talicia® H. pylori eradication data as well as publication and presentation of data from the opaganib and RHB-107 (upamostat) late clinical-stage COVID-19 programs at important medical congresses in July and August, 2022.
Talicia[1]: Publication of a study entitled "Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia®) is Unaffected by High Body Mass Index" in the journal GastroHep has been selected by reviewers for oral presentation at the World Gastro 2022 congress, August 17-18. Such invitations to present are reserved for researchers with significant clinical findings published over the previous year. This post hoc analysis of 269 patients from the ERADICATE Hp and ERADICATE Hp2 Phase 3 clinical trials, demonstrated that Talicia is highly effective in eradicating H. pylori irrespective of patient BMI, including in obese and severely obese patients, compared to the active comparator (P<0.0001). Patients with a BMI between 30-40 kg/m2 and those with BMI >40kg/m2 treated with Talicia achieved eradication rates of approximately 90% (88.1% and 90.9% respectively) versus active comparator rates of 62.9% and 31.8% respectively - an approximately 50% lower eradication rate in the severely obese group for the active comparator. Talicia is the leading U.S. branded prescription medicine for H. pylori eradication.
Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer, said: "Because more than 70% of Americans are either overweight or obese[2], and because increased BMI has been linked to reduced eradication outcomes of many commonly used H. pylori therapies, this important work supports Talicia as a rational first line option regardless of patient BMI."
RedHill's novel, oral, variant-agnostic late clinical-stage COVID-19 drug candidates, opaganib and RHB-107, have had data selected for publication or presentation as follows:
Opaganib[3]: Suggested host-directed mechanism of action described in a manuscript entitled "Recent Progress in the Development of Opaganib for the Treatment of COVID-19" accepted for publication in the journal Drug Design, Development and Therapy: The paper outlines opaganib's multi-faceted potential to: inhibit spike protein-ACE2 binding, Akt signaling and endocytosis, induce autophagy and apoptosis, and disrupt the viral RTC (replication-transcription complex) through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS). These mechanisms support the hypothesis of broad antiviral effect and attenuation of multi-organ dysfunction in COVID-19 patients. Moreover, because of this tripartite targeting, viral resistance to opaganib is unlikely to be encountered through adaptive mutation during therapy or random mutation to generate additional viral variants.
2nd ARDS Drug Development Summit, Boston, July 13-15: Data to be presented from the opaganib Phase 2/3 study showing the potential for a new methodology for selecting COVID-19 patients for treatment with opaganib, based on a new paradigm for classification of disease severity utilizing baseline Fraction of Inspired Oxygen (FiO2), in which opaganib demonstrated a 62% reduction in mortality in patients requiring FiO2 up to 60%.
Opaganib and RHB-107 (upamostat)[4]: International Conference on Emerging Infectious Diseases (ICEID), Atlanta, August 7-10: Data to be presented at ICEID, the premier infectious disease conference hosted by the CDC and the Global Task Force for Health, will include: Prespecified analyses from opaganib's Phase 2/3 study (NCT04467840), showing improved viral RNA clearance, faster time to recovery and reduced mortality in key subpopulations of opaganib treated moderate to severe hospitalized patients with COVID-19. Data for RHB-107, from Part A of its two-part Phase 2/3 study in a non-hospitalized setting, includes demonstration of a 100% reduction in hospitalization due to COVID-19 and an approximately 88% reduction in reported new severe COVID-19 symptoms after treatment initiation.
Dr. Mark Levitt, RedHill's Chief Scientific Officer said: "Acceptance for publication and presentation of these important data is testament to the quality and strength of RedHill's R&D capability. Oral opaganib and oral RHB-107, both of which have novel host-targeting antiviral mechanisms, have shown effect across multiple variants and virus models, and could serve as important tools in responding to the current and future pandemic waves, whether caused by SARS-COV-2 variants or by other viruses, and of particular concern, as Fall/Winter approach, is the specter of both COVID-19 and influenza circulating in abundance. We are seeing a shift in focus of government funding sources, public health experts, institutions and industry towards looking for broad host-directed antiviral mechanisms of action that will not be subject to resistance by viral mutation and that could address emerging new variants of SARS-CoV-2 and also combat other viruses that might create future pandemic waves - a more sustainable long-term approach than having to rediscover and reinvent very specific antiviral therapeutics which quickly become obsolete in the face of rapidly mutating viruses."
About H. pylori infection
H. pylori is a bacterial infection that affects approximately 35%[5] of the U.S. population, with an estimated two million patients treated annually[6]. Worldwide, more than 50% of the population has
H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[7] and a major risk factor for peptic ulcer disease[8] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[9]. More than 27,000 Americans are diagnosed with gastric cancer annually[10]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[11].
About Talicia
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[12] to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm[13].
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, investigational sphingosine kinase-2 (SK2) selective inhibitor, with suggested dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and, based on data accumulated to date, is expected to maintain effect against emerging viral variants, having already shown in vitro inhibition against variants of concern, including Omicron and Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
In prespecified analyses of Phase 2/3 clinical data, oral opaganib has demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv. Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, published in Open Forum Infectious Diseases.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in the prostate cancer study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[14].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, once-daily orally-administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.
So far - so good!
I have mine crossed!
1.1600 +0.1800 (+18.3673%)
Pre-Market: 5:24AM EDT
Hopefully price holds!
Fingers crossed.
I think it would be hard in these times to find anyone not in red.
Covid was one thing. Then the inflationary pressures were to be expected. The spanner in the works is the Russia-Ukraine-Energy-Food situation. That is what has further pushed the markets down to unexpected lows.
I still feel for the most part the investments are in sound companies, and am staying the course :)
Well things generally positive.
Talicia:
Talicia sales up another 13% Q/Q. Would like to see faster uptake, but these are still relatively early days of promotion. Meanwhile insurance coverage continues to expand with unrestricted and preferred status.
At Q1 sales of 6,602 new prescription x cost of approx low end cost of 700usd = just over 4.5 million revenue from Talicia in Q1. And based on Micha's comments sales appear to be showing better for Q2 quarter. So hoping from at least 30-35 million in its first real year of sales and promotion with US Covid situation having improved and past the acute stage as Fauci stated in end-April.
Insurance coverage apparently highest compared to other H.Pylori brands. I would be curious if this just refers to Branded, or also included generics of other Branded. But not a huge matter at the moment.
Good that the on the call the analyst brought up about the newly approved H.Pylori treatment. But Talicia still hands-down the best H.Pylori product, efficacy and convenience of administration.
The new vonoprazan treatments continuing to follow the highly inconvenient triple and dual pack forms, compared to Talicia one pill type, and Talicia efficacy at 84% eradication in the ITT pop, and up to 90% eradication in the PK pop, compared to vonoprazan at 84.7% for triple and 78.5% for dual pack. While in clinical studies dual and triple pack might perform will. In the real world their inconvenient form lowers their efficacy significantly.
Talicia dosage & administration:
- Four (4) TALICIA capsules every 8 hours for 14 days with food
https://www.rxlist.com/talicia-drug.htm#indications
Vonoprazan dosage & administration:
- For the vonoprazan Dual pack: Vonoprazan 20 mg twice daily (BID) + amoxicillin 1 g. Three times daily, for 14 days.
- For the vonoprazan Triple pack - vonoprazan 20 mg twice daily (BID) + amoxicillin 1 g BID + clarithromycin 500 mg, BID, for 14 days.
https://clinicaltrials.gov/ct2/show/NCT04167670
Note that where vonoprazan showed the 84.7% eradication in the triple pack, this refers to the regimen that included taking clarithromycin, which is the major contributor to H.Pylori treatment resistance we see today, which is why the FDA and WHO put H.Pylori on their high priority lists for seeking new treatments. Talicia doesn't have this issue as it uses rifabutin instead, and in a dosage form that can't be copied with generic substitute.
Meanwhile as was mentioned the more noise in the H.pylori market the better.
Movantik:
Having improved in sales in general, Movantik seems to have had "on-par" sales with Q4/2021, but it should keep having growth based on the pamora class Rx growing rapidly and with Movantik already having 9 of 10 lives covered by insurance and currently taking 74% market share in the Pamora class, as the class grows so should Movantik sales.
Opaganib & Upamostat:
Good to see that Opaganib, is looking to go into it's expected confirmatory study and going ahead without too much RedHill funding. Also just nice to see Opagnib activity as a broader anti-viral agent.
Good to see, Upamostat is apparently expected to be included in Covid platform studies that will be carried out without financial expense to RedHill.
Overall cash usage going down with revenues look to go up.
Most welcome Scrapiron,
1.0800 +0.06 (+5.88%)
Pre-Market: 05:58AM EDT
Momentum continues!
midastouch,
Thanks for the update!
RedHill Biopharma Ltd. (RDHL) CEO Dror Ben-Asher on Q1 2022 Results -
Earnings Call Transcript
Jun. 23, 2022 1:25 PM ETRedHill Biopharma Ltd. (RDHL)
RedHill Biopharma Ltd. (NASDAQ:RDHL) Q1 2022 Results Conference Call June 23, 2022 8:30 AM ET
Company Participants
Debbie Bechor - Business Development & Communications Manager
Dror Ben-Asher - Chief Executive Officer
Rick Scruggs - President and Chief Commercial Officer
Guy Goldberg - Chief Business Officer
Gilead Raday - Chief Operating Officer
Micha Ben-Chorin - Chief Financial Officer
Adi Frish - Chief Corporate and Business Development Officer
Rob Jackson - Senior Vice President of Marketing
Conference Call Participants
Brandon Folkes - Cantor Fitzgerald
Boobalan Pachaiyappan - H.C. Wainwright
Matt Kaplan - Ladenburg Thalmann
Operator
Good day, and welcome to RedHill Biopharma's First Quarter 2022 Financial Results and Operational Highlights Conference Call. [Operator Instructions]
At this time, I would like to introduce to the conference call RedHill's CEO, Dror Ben-Asher; Rick Scruggs, President of RedHill Biopharma, Inc. and Chief Commercial Officer; Guy Goldberg, Chief Business Officer; Gilead Raday, Chief Operating Officer; Micha Ben-Chorin, Chief Financial Officer; Adi Frish, Chief Corporate and Business Development Officer; and Rob Jackson, Senior Vice President of Marketing.
Before we begin, we will read from RedHill's Safe Harbor statement. Please go ahead.
Dror Ben-Asher
Thank you, Debbie. Good day, everyone, and thank you for joining our first quarter earnings call.
To address the current market reality, RedHill is decisive about controlling its own destiny. We are highly focused on achieving earlier profitability, targeting positive cash from operations to start during the second half of 2022. Our comprehensive cost reduction plan is expected to generate operational cost savings of approximately $50 million over the next 18 months. We are already seeing a significant positive impact of our disciplined cost control approach, with a reduction of over 70% in cash used in operating activities in the first quarter.
The majority of our cost reduction plan, the savings, results from an approximately 1/3 reduction of the U.S. commercial team workforce. We have also streamlined operational expenditure, including SG&A expenses and also refined the Company's R&D strategy to rely mostly on external funding sources for now. Based on the promising clinical data generated to date, our excellent R&D progress will be discussed shortly by Gilead Raday, our Chief Operating Officer.
On behalf of the Company, I would like to express my profound and respectful gratitude to the colleagues who have departed RedHill. While difficult, the changes we have made as part of our cost reduction plan, where necessary, given the current reality. I would also like to thank our resilient and highly driven team as well as various stakeholders for their patience and support as we continue to diligently and decisively grow the business against various headwinds.
In summary, RedHill significantly improved financial stability results from major cost savings, a robust commercial portfolio with three FDA-approved proprietary drugs, continued prescription growth, expanded managed care coverage and the recently improved credit agreement with Healthcare Royalty.
RedHill is, therefore, well positioned for further growth, both organically from our own pipeline and non-organically through potential acquisitions of additional revenue-generating synergistic products to expedite and increase cash generation, both in the short term and the longer term.
I will now be turning to our Chief Business Officer, Guy Goldberg, and the rest of the team for our detailed commercial R&D financial presentation to be followed by Q&A discussion.
Operator
Unfortunately, it appears that we have a slightly technical problem. We will be with you in just one moment. [Technical difficulty]
Guy Goldberg
Thank you, Dror, and apologies to our listeners who had to bear with us while we had some technical challenges. I will start at the beginning of Slide 4. This is Guy, and I'll walk through an overview on my section, and then we'll continue the presentation. So Dror just made his remarks, and I'll be now on Slide 5.
So RedHill is going through an important transformational process to achieve financial independence. This is one of the longest and deepest downturns that the biotech sector has ever been through. Only resilient companies will emerge stronger at the end of the tunnel. In this new reality, RedHill implemented important cost control measures to weather the storm. In other words, as can be seen in the illustration at the bottom of the slide, by investing less, we're able to conserve cash and speed up the point where we achieve breakeven.
We have been implementing a comprehensive cost reduction program that aims to make us cash flow positive from operations during the second half of 2022. By focusing on achieving operational profitability earlier, we expect savings of approximately $50 million over the next 18 months. In conjunction, we have completed other complementary initiatives to support this strategy, including improving the terms of key covenants in our credit agreement with our partner, Healthcare Royalty.
We're also continuing discussions on various BD opportunities that fit the strategic goal that is commercial stage products that match our current call points and are accretive in terms of revenue and return on investment. We have a top-tier commercial organization in place and any additional product would benefit from our excellent commercial team drive, talent and experience and would also see the benefit company-wise of economies of scale.
Next on R&D, while RHB-204 continues to progress as before, for our other programs including our two COVID drug candidates, we are currently expecting to advance those programs through external funding. We are committed to our COVID programs and believe the data we have generated is highly promising and justifies continued development. In this funding environment, we are in discussions for other non-dilutive sources of capital, including public and private grants, largely in the U.S. and Europe, COVID-19 platform studies and industry partnerships.
This slide shows our R&D activities. I want to emphasize that our COVID-19 programs, opaganib and upamostat, are core programs for RedHill, and we will continue to move forward. The need for oral therapeutics in this space is still acute. Research indicates that the new sub-variance of Omicron shows substantial resistance to vaccine-induced and infection-induced serum neutralizing activity. COVID continues to be an important field of drug development for two reasons.
First, it is an ongoing and future public health threats with a huge unmet medical need. And second, it has shown to be a very large, relatively undeveloped market opportunity. We are firm believers in our COVID programs, and we think are their unique post-directed mechanism of action puts us at the forefront of development in this field, in fact, the broad-acting antiviral nature of our programs to be very important with the growing general interest in pandemic preparedness. Gilead will provide more updates on our COVID programs and other development programs later.
I will now turn it over to Rob to discuss our commercial progress.
Rob Jackson
Thank you, Guy, and good morning. Over the next few minutes, I'm going to summarize the progress we made during the first quarter with our sales, marketing and market access activities so that you can understand why we continue to feel confident about where the business is heading this year. Our clear corporate priorities are to drive revenue growth and manage expenses as we continue to progress towards operational profitability in the second half of 2022.
I'd like to begin my presentation by recognizing the efforts of our RedHill colleagues, especially our sales team, as we all strive to deliver consistent profitable growth. Thank you to everybody for your contributions. During the first quarter, RedHill achieved record quarterly prescription volume.
In the first quarter, RedHill delivered our second best quarterly performance Movantik, since we add Movantik to our portfolio. We maintained a very strong prescribing trend during the always challenging start of a new deductible season, and Movantik continues to maintain clear market leadership with the PAMORA class with nearly 74% market share.
During the first quarter, RedHill grew Talicia prescription volume by 12.8% over the fourth quarter of 2021, a significant achievement following our very strong record close to last year. Talicia prescription volume has surpassed Pylera, establishing Talicia is the most prescribed branded H. pylori therapy in the United States.
This is strong evidence that payers and prescribers increasingly and rapidly recognize Talicia's ability to overcome the combined challenges of clarithromycin resistance, H. pylori regimen tolerability and diminished efficacy. And these are the issues that frustrate prescribers and patients every day, consuming valuable health care resources and forcing patients to endure multiple rounds of a 14-day antibiotic regimen while searching for an effective therapy such as Talicia.
Our two lead brands are well positioned to continue the performance trends into the second half of the year. In the month of June, we've already achieved new weekly prescription volume records for both Movantik and Talicia, we're closing the second quarter with a trend of growing volume and are entering the third quarter with positive momentum.
During the first quarter, RedHill delivered Movantik prescription volume that was within 1% of our record fourth quarter results. And our first quarter volume represented an 8.6% improvement over what we achieved in the first quarter of 2021. We achieved this by continuing to take a disciplined approach and focusing on target prescribers in the pain specialty segment.
In tandem, we also executed marketing strategies focused on growing the PAMORA market. This is a key objective for Movantik as the established market leader, and we invested to raise opioid-induced constipation awareness with patients and prescribers and also to educate these potential customers about how Movantik can provide relief from the symptoms of opioid-induced constipation.
The positive impact of these investments in market development can be seen in the next slide. Looking at the 12-month moving annual total of PAMORA prescriptions, a clear trend of market growth has developed over the past three quarters. This is a significant change for the PAMORA class, reflecting RedHill's investment in building awareness of opioid-induced constipation and encouraging provider patient conversations.
Many believe the PAMORA class would decline in tandem with the opioid market. In fact, the opposite is happening, and we expect that opioid prescribing may flatten or even increase in the near future, providing further support for the PAMORA market. Movantik is the clear market leader and Movantik will disproportionately benefit from more patients being treated with PAMORA agents.
Recently, CDC announced draft revisions to their 2016 opioid prescribing guideline, and this new guideline is expected to provide further support for opioid use in patients experiencing chronic pain. In fact, one of the reported intents of the revised guideline is to address the misapplication of the 2016 guideline and CDC expects to publish their final guidance by the end of this year.
It remains to be seen, but the new guideline may relax some portions of the 2016 guideline resulting in a potential increase in responsible opioid prescribing and a subsequent increase in demand for PAMORA agents. An alternative view of Movantik prescribing data, the 13-week moving annual total trend also shows robust growth as we move into the second quarter of 2022.
After facing the challenge of the COVID-19 pandemic and the allocation of corporate focus on Talicia launch in 2020, we successfully developed a positive growth trend for Movantik that continues to improve.
To summarize, Movantik continues to achieve new milestones. Movantik delivered 8.6% growth versus first quarter 2021. Movantik maintains its competitive advantage of having best-in-class payer coverage with nearly 92% of insurance plans providing access from Movantik. And since original launch, more than 3 million Movantik prescriptions have been dispensed.
Simultaneously, Talicia continued to achieve new milestones. And as you can see in this graph, monthly prescription volume continues to increase consistently. In the first quarter, Talicia achieved its best ever performance in terms of prescription volume and market share, and our March volume represented a strong finish to the first quarter.
In the first quarter, Talicia achieved 12.8% quarter-on-quarter growth and record prescription volume building on the record volume previously achieved in the fourth quarter of last year. And additionally, when we compare first quarter of 2022 to first quarter of 2021, Talicia's first quarter results represented an 80% growth in prescription volume, and we expect this trend to continue.
On the payer front, our market access team has continued to improve our already competitive position with payers. Effective January 1 of this year, Talicia became available to 14 million Medi-Cal beneficiaries as a preferred brand with no restrictions. This has helped RedHill accelerate to easy uptake in what is the second largest individual state for H. pylori infections and treatments.
Effective April 1, Talicia gained similar coverage on Florida Medicaid. Additionally, another large Part D plan per coverage became effective earlier this quarter. And effective July 1, another national PBM will improve access to Talicia on its commercial formulary, improving Talicia's position from restricted, not preferred to preferred.
We expect to see a further prescription volume lift from this win during the second half of 2022, carrying into 2023. These wins are consistent signs that healthcare providers and payers are increasingly recognizing; first, the challenge of clarithromycin resistance. These challenges are clearly outlined by the American College of Gastroenterology's 2017 guidelines; secondly, the pitfalls of continuing to persist, using clarithromycin based therapy as a first-line treatment of choice and third, the clinical benefits of prescribing Talicia.
To summarize, Talicia continues to achieve new milestones. We achieved record prescription volume driven by 12.8% volume growth over the fourth quarter of 2021 and 80% growth over what we had in the first quarter of last year. We've generated significant improvements in payer coverage and we currently have the highest level of payer coverage compared to any of the other branded H. pylori therapies.
In summary, we finished the first quarter with a consistent growth trend for our two lead brands: Movantik and Talicia. We remain focused on our corporate priorities of driving revenue growth and managing expenses as we continue to progress toward positive cash from operations and increase independence in the second half of this year.
As a market leader in the PAMORA class, we demonstrated our ability to continue to grow new Movantik prescriptions, grow prescription volume in the PAMORA class, and further improve on already strong Movantik payer coverage.
We continue to build the case for Talicia with payers, emphasizing the known shortcomings of clarithromycin based therapies and the clinical benefits of prescribing Talicia. And we continue to advance new ways to grow and pull up volume in the primary care segment. We look forward to further growing our business during the remainder of the year.
And thank you and I'll turn the call back to our COO, Gilead Raday
Gilead Raday
Thank you, Rob. I will provide a brief update on our R&D activities. Opaganib is our orally administered, first-in-class selective sphingosine kinase 2 inhibitor in advanced clinical development. Opaganib has broad antiviral activity and inhibits viral replication of multiple types of viruses, including COVID-19.
Opaganib also reduces the body's excess immune response, providing a dual action benefit to patients with severe inflammatory response to viral infection. Opaganib development is also being continued in oncology indications with cholangiocarcinoma Phase 2 top line data expected in Q3 2022.
With promising data from the Phase 2/3 study in hospitalized COVID patients and with new data confirming opaganib's antiviral activity also against influenza, which I will discuss in the coming slides, opaganib is a highly promising therapeutic candidate for viral pandemic preparedness, which is the current spotlight of public health events.
RHB-107 is our second clinical stage novel COVID-19 oral field candidate. RHB-107 is well positioned to treat early-stage mild to moderate COVID-19 infection, through targeting human serine proteases, which are hosted [indiscernible] in viral replication.
We announced positive and promising results from Part A of a Phase 2/3 study in non-hospitalized symptomatic COVID-19 patients that show upamostat potential capacity to prevent the deterioration with excellent safety and tolerability and are progressing towards potential participation in COVID-19 outpatient platform study.
With opaganib and RHB-107, RedHill holds two promising products that could serve as important tools in responding to future pandemic waves, where they caused by SARS-CoV-2 variants or by other viruses.
In fact, we are seeing a shift in focus of government funding sources, public health experts, institutions and industry towards looking for broad antiviral mechanisms of action that could address emerging new variants of SARS-CoV-2 and also combat other viruses that might create future pandemic waves.
This is a more sustainable long-term approach than having to rediscover and reinvent very specific antiviral therapeutics, which quickly become obsolete in the face of rapidly mutating viruses. The novel host targeting antiviral mechanisms of RedHill's opaganib and RHB-107 are highly suitable to meet the demand of this long-term pandemic preparedness approach.
RHB-204 is the most clinically advanced stand-alone oral therapy in development for first-line treatment of pulmonary non-tubriculous mycobacteria. The ongoing Phase 3 study is progressing.
Overall, in line with our strategy to support operational profitability in the second half of 2022 and in view of the highly promising clinical and preclinical data generated to date, we anticipate external funding for much of our promising R&D programs through grants, industry partnerships and participation in platform study. I will highlight some further details regarding each program in the next few slides.
Opaganib clinical data package has been submitted to several regulatory agencies. Based on regulatory input, a positive confirmatory study constitutes the likely pathway to potential opaganib's submissions for approval in the U.S., EU and multiple other territories. As a reminder, the global Phase 2/3 data met part of its pre-specified endpoints.
The study showed a 70% reduction in mortality for opaganib when given on top of remdesivir and corticosteroids, with less than 7% mortality in opaganib arm versus over 23% mortality in the placebo control arm with a p-value of 0.034. Opaganib also provided a 34% benefit in time to recovery by day 14 with a p-value of 0.013.
Additionally, opaganib improved the median time to viral RNA clearance by at least four days, with a hazard ratio of 1.34, a nominal p-value of 0.043. Seeing an improvement in viral clearance at such a late stage of the viral infection in patients with a median of 11 days from onset of symptoms is a unique clinical finding, which is indicated opaganib's antiviral effects in the most challenging clinical setting of advanced and severe viral infection.
Further cost of analysis also showed the market benefit in reducing mortality, a 62% reduction in large subpopulation of over half of the study participants, which consisted of moderately severe post-hospitalized COVID-19 patients. Data from the global Phase 2/3 study has recently been published on Medarex ID and is in submission processes to peer-reviewed scientific journal.
The results will also be subject of a late-breaker oral presentation at the International Conference on emerging infectious diseases, which is hosted by the CDC in collaboration with the task force for global health to be held this August in Atlanta.
Adding to opaganib's expanding patent suite on June 21, 2022, RedHill was granted an additional U.S. patent, covering a method for the treatment of patients with moderate to severe COVID-19 using opaganib.
Given its broad antiviral activity, opaganib is continuing to be developed for treating additional viral infections, including RSV, Ebola and influenza. Previous data has indicated opaganib's capacity to inhibit Ebola virus application. Recent new data utilizing preclinical services from the National Institute of allergy and infectious diseases, which is part of the National Institute of Health, demonstrates opaganib's potent activity against influenza A H1N1 strain.
The results were obtained in human bronchial epithelial cells, which are the natural human target of the virus, making the test assay a realistic model of the infection. Opaganib achieved potent inhibition of viral replication at low concentrations with no evidence of toxicity at those levels.
As can be seen from the results, opaganib inhibited 90% of viral replication at concentration which was over 60 times lower than the concentration that reduces cell viability by 50%. This markedly exceeds the target threshold for indicating potent antiviral activity in this assay and provides further evidence of opaganib's potential broad-spectrum antiviral activity.
We are also continuing to advance opaganib's development program in oncology and inflammatory indications with cholangiocarcinoma Phase 2 study top line analysis expected in Q3 2020. As previously announced, RHB-107, also called upamostat, provided positive top line results from Part A of the Phase 2/3 study in outpatients in the U.S. Part A met the primary endpoint of safety and tolerability.
Moreover, Part A provided highly promising efficacy results despite its small sample size of 61 subjects. We saw a 100% reduction in COVID-19-related hospitalization with 0/41 patients who were treated with RHB-107 versus 15% on the placebo control arm requiring hospitalization. There was also an 88% reduction in reported new severe COVID-19 symptoms after treatment initiation.
Only one RHB-107 patients out of 41, equating 22.4%, reported new severe COVID-19 symptoms versus 20% of patients reporting new severe COVID symptoms in the placebo control arm. Importantly, for early-stage COVID-19 infected patients, RHB-107 presents a highly favorable profile. It is taken orally once a day as a stand-alone treatment with excellent safety and with no major drug-drug interactions limiting its potential use.
Given the promising outcomes, work is underway to complete data analysis and submit to regulatory agencies for moving into Phase 3 studies. Further, we anticipate potential participation in a platform study, which is in advanced regulatory preparations with FDA. RHB-204 is the only first-line stand-alone oral treatment in late-stage clinical development for pulmonary NTM disease caused by mycobacterium avium complex, MAC, a rare condition with no FDA-approved first-line therapy.
We continue to advance the ongoing Phase 3 study in first-line pulmonary non-tuberculous mycobacteria towards potential NDA submission for this indication. We are expecting enrollment to pick up with the waning of COVID-19 in the U.S. and with expansion of study participating sites.
As a reminder, the study is a randomized placebo-controlled study and has a six-month co-primary endpoint sputum culture conversion and clinical benefit using patient-reported outcomes. After the first six months, study subjects cross over to open-label active treatment with RHB-204 for an additional 12 months from conversion in accordance with clinical practice.
Of note, RHB-204 has been granted Orphan Drug Designation and QIDP status. Together, these designations provide for expedited development, priority review of the NDA and a total of 12 years market exclusivity from potential approval in the U.S. We see a lot of interest from industry in this program and are in discussions with several potential industry partners to further support and accelerate.
I will now turn it over to Micha for reviewing the Q1 2022 financial results.
Micha Ben-Chorin
Thank you, Gilead. RedHill is now focusing on cash flow and financial independence. This facilitated the achievement of positive contribution from our commercial operations segment for the first time in Q4 of last year. And we are now targeting positive cash flow from operations before interest payment for the whole company to start during half two of this year. This follows recently implemented comprehensive cost reduction plan, which expected operational cost savings of approximately $50 million over the next 18 months.
Importantly, looking at Q1, continuous implementation of cash optimization measures, reduced cash used in operating activities by more than 70%, to approximately $4 million compared to approximately $15 million in Q4 of last year, signaling a clear path towards our stated goal of achieving financial independence.
Net revenues of $18.2 million in Q1 compared to $22.1 million in Q4 of last year reduced revenues are due to typical cyclical trends in Movantik sales, which remains on track in Q2 with the last week measured earlier this month, showing record scripts of both Talicia and Movantik.
Gross profit was $10.2 million in Q1, representing 56% gross margin, which is expected to continue to improve as Talicia scripts continue to grow. Research and development expenses for the quarter were $3.1 million as compared to $5.9 million in the fourth quarter of 2021. This decrease was attributed to the ongoing optimization of R&D costs and completion of elements of the opaganib and RHB-107 development programs.
As compared with previous quarter, we had lower operating loss, lower net loss and lower cash used in operating activities. This led to cash position of approximately $45 million as of March 31 of this year. Prior to the $15 million of gross proceeds from our registered direct offering in May.
To summarize, our projected organic sales growth potential in licensing and synergies FDA approved revenue-generating products and out-licensing activities together with our vigorous cost reduction plan, position strategy well to achieve our target of positive cash flow from operations before interest payments expected to start during the second half of this year.
I'll now turn the discussion back to Dror, to Q&A.
Dror Ben-Asher
Thank you, Micha. We are happy to take questions.
Question-and-Answer Session
Operator
[Operator Instructions] Our first question today comes from the line of Brandon Folkes from Cantor Fitzgerald. Brandon. Brandon, please go ahead. Your line is open.
Brandon Folkes
Thanks for taking questions and thank you for all the updates today. Maybe just firstly, can you talk about the reduction of the commercial team? And any impact on overall sales. Maybe just some color in terms of will those territories be covered by the remaining reps or though they remain uncovered? And then secondly, maybe just staying on the commercial portfolio, how do we think about gross to net in 2022 compared to 2021?
Dror Ben-Asher
Thank you, Brandon. As far as the gross to net starting from your second question, I refer to Micha. And the first question thereafter will be taken by Rick, our Chief Commercial Officer. Micha, please.
Micha Ben-Chorin
We believe we stabilized on gross to net, and we will continue in more or less where we are now.
Brandon Folkes
I'm sorry. And how does that compare to last year?
Micha Ben-Chorin
The comparison of last year is a little bit more gross to net because of the coverage increase.
Dror Ben-Asher
Brandon, are you okay on gross to net, should we continue?
Brandon Folkes
Yes, please.
Dror Ben-Asher
Thank you. Well, gross to net, it has to with increased coverage. Rick, please.
Rick Scruggs
Yes, sure. So this is Rick. I will just briefly mention or answer your question. We did do a comprehensive analysis of our commercial operation. We did a comprehensive analysis of all the territories, the territories that were profitable, the territories have had opportunities for growth, the territories that could be merged. We did merge territories. We did line up with a few territories going to white space. We do employ in our commercial organization, a group called Customer Engagement Specialists.
They answer questions from physicians also reach out to physicians and the white space. So we have consolidated. We have consolidated sales leadership as well. So we did a lot of consolidation. And we did this with the eye to hit our revenue targets for this year and into 2023. It was a tough reorganization, but there's something we need to do, and we have successfully completed that operation, and we feel poised to go forward right now.
Brandon Folkes
And maybe just one more, if I may. And on the $50 million OpEx savings over the next 18 months, any color in terms of how quickly you expect that to be achieved? Or how we should at least think about modeling that over the 18 months?
Micha Ben-Chorin
Yes. So, we prepared a very detailed plan, which shows that in the next coming six quarters, more or less on the same pace, we will save those $50 million.
Operator
Thank you. The next question today comes from the line of Boobalan Pachaiyappan from H.C. Wainwright. Please go ahead. Your line is now open.
Boobalan Pachaiyappan
This is Boobalan. Can you hear me okay?
Dror Ben-Asher
Very well. Thank you.
Boobalan Pachaiyappan
All right. Great. A few questions from our end. So I wanted to start off our discussion first by focusing on potassium competitive acid blockers. So obviously, one of your competitors recently received FDA approval. So just to kind of hear your thoughts on this on the kind of upward pressure these agents can put on Talicia sales? And also, how do you see the evolution of H. pylori treatment in the wake of potassium channel blocker approval?
Dror Ben-Asher
Thank you, Boobalan. Gilead will answer the first aspect. And Rob Jackson, our Head of Marketing and Sales, will discuss about the evolving landscape. We'll start with Gilead.
Gilead Raday
Thank you. So Talicia, to put it succinctly, as best-in-class on-label efficacy, especially in addressing the clari-resistant population, which is the major issue for empirical first-line treatment of the H. pylori infection. So, we're highly confident in Talicia continuing to be the leading brand for H. pylori treatment going forward.
Dror Ben-Asher
Thank you, Gilead. Rob, would you like to speak about how we see the landscape evolving?
Rob Jackson
Absolutely. Thank you, Dror. I think as a company, we certainly welcome the increased focus on H. pylori infections and the need for new treatments. So, we think any additional noise that comes into the category from a new entrant will be a positive. In terms of how we'll stand up against the new competition, how this impacts the competitive landscape, to Gilead point, I think resistance is really the key issue here.
And what we've identified with Talicia in our clinical studies is we have 90% efficacy, really regardless of the patient's resistant status. And that's a true differentiator for Talicia, it's going to stand strong for the brand in the long term. And I think that's going to really play into our favor as the market grows, I think we'll continue to capture a disproportionate share of that business.
Boobalan Pachaiyappan
Okay. And then the next one. So it appears you're doing two things at once, which are cost reduction and achieving profitability. So what's interesting is that the cost reduction comes in the backdrop of a rising momentum in Movantik and Talicia sales. So Guy presented an interesting graph, and I believe the slopes are communicating some value. Just curious whether the priority here is to achieve early profitability, but grow at a slow pace rather than grow fast, but ambition profitability at a later stage.
Dror Ben-Asher
Thank you, Boobalan, and excellent question. We have a very clear priority to preserve cash and generate as much cash as possible and time breakeven during the second half when it comes to cash from operations. This is the clear goal. Longer term, we want to achieve whole company P&L profitability, and we are having that. As far as sacrificing growth, as Rick outlined, we have done a lot of analysis, and we are confident that we can continue to grow given the cost optimization and shifting resources inside the Company together.
Boobalan Pachaiyappan
Okay. Great. Just two more, if I may. So today's press release mentioned that you are engaged in a non-binding discussion to acquire a GI drug. Just curious what has to happen in order for the process to complete? And how do you expect to fund the transaction?
Dror Ben-Asher
Thank you. Unfortunately, we cannot provide additional color on this one beyond what we already stated.
Boobalan Pachaiyappan
Understood. Just one last question. What are your thoughts on the commercial outlook for COVID-19 therapeutics targeting more severely ill patients given the evolving nature of the pandemic?
Gilead Raday
We see COVID-19 remain a problem -- very dynamic evolving problem with variants and mutations arising continuously. So the landscape is shifting, and it's very hard to predict exactly what comes next in terms of the waves of COVID-19 infection. Certainly, the public health focus in spotlight is on pandemic preparedness for waves of infection from SARS-CoV-2 variants, all from other sources of pandemics outside of the SARS-CoV-2 family line. So in the long term and in the short term, we see our antiviral programs is very much in the focus of public health interest, both for COVID-19 future potential waves both for early stage and late-stage infections and also for other potential viruses that are lying in the wake.
Operator
Thank you. The next question today comes from the line of Scott Henry from ROTH Capital. Scott, please go ahead. Your line is now open.
Scott Henry
Thank you and good morning. I guess for starters, it seemed like the call was later in the calendar year this year. Was there a reason for that?
Dror Ben-Asher
Thank you, Scott. There are several reasons for that. For example, you saw that we just announced an improved credit agreement. That was important. We also had other reasons for delay, but the results are announced already over a month ago in a public filing, so there was nothing that was particularly extreme in doing so.
Scott Henry
Okay. Fair enough. I just wanted to ask. And then I guess the other thing, I just wanted to understand the cash flow positive from operations and how you define that. Gross profit is about $10 million. SG&A is $20 million. It's hard to see how those numbers will match, but I think you're probably pulling some things out. So, I just wanted to get a better understanding of the way you define cash flow positive from operations?
Micha Ben-Chorin
Yes. Thank you for the question, Scott. So, obviously, we will need to do -- and we are doing a vigorous action on expenses -- on the expense side, and this is going to go down very substantially in all terms, whether it is sales and marketing, G&A and mainly R&D. And we also see our revenues continue to grow and even faster. And that will allow us to achieve cash from operations before interest payment starting from the second half of the year, whether it's going to be Q3 or Q4, we shall see.
Scott Henry
Okay. So you are including all G&A and selling expenses in that calculation?
Micha Ben-Chorin
Correct.
Scott Henry
I assume you're backing out stock comp, maybe you are, maybe you're not, but just for clarity.
Micha Ben-Chorin
Sorry. Sorry, can you repeat the question?
Scott Henry
So I guess by cash flow from operations, are you including G&A and selling expenses in that?
Micha Ben-Chorin
Yes, we do.
Scott Henry
Okay. So -- and are you including stock compensation?
Micha Ben-Chorin
No, because we are talking about cash flow, so the equity compensation will be in the P&L, and we are referring to cash flows.
Scott Henry
Okay. Okay. And approximately how much is that on a quarterly basis? I'm just trying to get a sense of what levers need to happen to close that, I mean, basically, you can close that $10 million gap.
Micha Ben-Chorin
We are third in the conference call to the percentage of the workforce that we are using. This will give you the answer of how this is going to look like. And on the R&D, since we completed the programs of COVID, you can assume that our R&D expenses will continue to go even lower than the levels that we presented and will also support the -- achieving positive cash from operations before interest payments.
Operator
Thank you. The next question today comes from the line of Matt Kaplan from Ladenburg Thalmann. Please go ahead. Your line is now open.
Matt Kaplan
Just wanted to kind of follow up on Scott's question. I guess, given the implementation of your cost-cutting plan, what's your current cash runway given your current cash levels of, I guess, 45 at the end of the quarter plus the registered direct. What's your, I guess, cash runway?
Dror Ben-Asher
Thank you, Matt. This is Dror. We have no going concern remark, as you probably noticed, and we feel confident not only in the next 12 months, which are covered by the no going concern remark, but well beyond that.
Micha Ben-Chorin
And just to add to that, according to the plan that we put together, we will be able to -- with the current cash that we have, as we said, to reach operational profitability in terms of cash flows and later on also to support our overall debt service. So we have enough cash in hand for the next coming quarters.
Matt Kaplan
Okay. That's helpful. And can you break out the revenue contribution performance for Talicia and Movantik for the first quarter?
Micha Ben-Chorin
So in this quarter, we had three main components, Movantik with a little over 14. We had an out-licensing deal for Talicia for $2 million and the rest commercial sales of Talicia.
Matt Kaplan
Okay. Thank you. And then regarding the pathway for opaganib from a regulatory point of view, can you give us some detail in terms of your thoughts for that pathway in COVID-19? I guess the question is, will it include more use authorization? Or is that off the table, you have to do a full clinical development plan right now?
Gilead Raday
So for COVID-19, the current expectation is that a confirmatory, a positive confirmatory study for either opaganib or also upamostat, depending on the situation of the pandemic support month use approvals, potentially also full applications depending on the outcome of the study, but that remains to be seen, and also depending on the state of the pandemic at the time of submission. I hope that answer.
Matt Kaplan
Yes, yes. And then last question in terms of RHB-204 and NTM. You're talking about potentially getting some external funding for that. I guess, can you plot out the two pathways there if you have to fund it yourself, the ongoing Phase 3? Where are you in enrollment there? And what does that look like if you fund it yourself? And then secondly, if you bring on some external funding, what's the timing of that program in both scenarios?
Gilead Raday
We haven't provided exact guidance on time lines, but of course, with additional sources of capital and resources, which could be provided by interested partners that could accelerate the timeframe of enrolling the patients, increasing the number of sites, possibly expanding the study also out of the U.S. to U.K. and Japan, for instance, which are very interesting territories with high unmet need and the potential market for NTM.
So, we see a lot of benefit in finding co-development partners, and there's a lot of interest in that respect and ongoing discussions. That's where we think the benefit to accelerating the study can come in. We hope to be able to enroll the study, I would say, within 1.5 years. And that could put six months accelerated review of an NDA and six-month primary endpoint allow for a pretty rapid completion of the study and proceeding towards NDA filing.
Operator
Thank you. That concludes today's question-and-answer session. So I'd like to pass the conference back over to Dror Ben-Asher for closing remarks.
Dror Ben-Asher
Thank you. Thanks all for joining the call. Please reach out to us if you have any additional questions. Keep safe, and have a pleasant day.
Operator
That concludes today's conference call. Thank you all for your participation. You may now disconnect your lines.
RedHill GAAP EPS of -$0.03 in-line, revenue of $18.2M misses by $5.4M
Jun. 23, 2022 8:26 AM ETRedHill Biopharma Ltd. (RDHL)
By: Deepa Sarvaiya, SA News Editor1 Comment
RedHill press release (NASDAQ:RDHL): Q1 GAAP EPS of -$0.03 in-line.
Revenue of $18.2M (-11.5% Y/Y) misses by $5.4M.
Cash Balance as of March 31, 2022, was $45.0 million, as compared
to $54.2 million as of December 31, 2021.
Shares +35% PM.
RedHill Biopharma Announces Q1/22 Highlights: On Track for Positive Cash from Operations in H2/22
https://finance.yahoo.com/news/redhill-biopharma-announces-q1-22-110000247.html
Targeting positive cash from operations to start during H2/22[1]
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 balance[2] 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, N.C., June 23, 2022 /PRNewswire/ -- 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 and recent implementation of a comprehensive cost reduction plan, expected to generate operational cost savings of approximately $50 million over the next 18 months.
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."
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.
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 opaganib[4] 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.
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.
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.
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) Disease[9]
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.
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.
RedHill Presents New Talicia® Data Analyses at DDW 2022
https://finance.yahoo.com/news/redhill-presents-talicia-data-analyses-131500548.html
Talicia's efficacy and safety profile evaluated in patients with H. pylori infection and diabetes mellitus, a large and challenging patient population associated with sub-optimal outcomes with clarithromycin-based H. pylori eradication therapy
Physiologically based pharmacokinetic modeling study of Talicia evaluated intragastric antibiotic exposure, which is critical for successful H. pylori eradication, by comparing low-dose rifabutin 50 mg every 8 hours to the generic formulation of rifabutin 150 mg once a day
Talicia, the leading FDA-approved brand for H. pylori treatment, is intended for empiric first-line eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population, representing significant unmet need
RALEIGH, N.C. and TEL AVIV, Israel, May 25, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the presentation of two new data analyses from the Talicia® H. pylori eradication clinical trials program at Digestive Diseases Week (DDW) 2022.
The first analysis evaluated the maintenance of Talicia's efficacy and safety in the treatment of patients with H. pylori infection and diabetes mellitus (DM). DM is associated with higher rates of H. pylori infection and higher rates of treatment failure with clarithromycin-based therapies. Furthermore, clarithromycin interacts with some common diabetes medications potentially leading to hypoglycemia1.
The second analysis, a physiologically based pharmacokinetic (PBPK) study, used modeling to compare Talicia's low-dose rifabutin formulation's (rifabutin 50 mg every 8 hours) sustained intragastric antibiotic exposure, a critical component of successful H. pylori eradication, to exposure rates seen with the generic formulation of rifabutin (150 mg taken once daily (QD).
Poster one (poster number: Tu1078): Low-Dose Rifabutin Triple Therapy (Talicia) Maintains High Helicobacter pylori Eradication Rates and Shows Favorable Safety and Efficacy in Subjects with Diabetes Mellitus.
Presenting Author: Dr. Colin W. Howden, MD, Professor Emeritus, University of Tennessee Health Science Center
This supplemental analysis of the pooled modified intent-to-treat (mITT) population (n=293) from two Phase 3 clinical trials (ERADICATE Hp, ERADICATE Hp2) assessed the safety and efficacy of Talicia in patients with DM. H. pylori isolates from treatment-naïve patients from study 2 were also tested for antibiotic resistance according to the presence of DM. The 293 patient-analyzable mITT population who received Talicia had pooled eradication rates of 91.7% (n=44) and 84.1% (n=206) in patients with and without DM, respectively (p=0.17). Moreover, no resistance was seen to rifabutin in patients with or without DM. Resistance rates were 4% v 7% for amoxicillin, 45% v 43% for metronidazole, and 21% v 17% resistance to clarithromycin in patients with and without DM, respectively. With the exception of an observed higher rate of diarrhea in patients without diabetes versus those with (13.8% vs 6%), the presence of diabetes did not alter the safety or tolerability of Talicia, and generally matched the safety profile of the total patient population.
"More than 37 million Americans have diabetes, which presents significant issues in the treatment of H. pylori infection. Firstly, we know that the risk of treatment failure with clarithromycin-based therapies is significantly higher in patients with diabetes2, and secondly, the use of clarithromycin in diabetic patients can impair the management of their diabetes due to drug-drug interactions," said Dr. Barry Johns, MD, from The Jones Center for Diabetes and Endocrine Wellness, Macon, GA. "Consequently, it is vital that we know which therapies are most appropriate for first-line H. pylori eradication treatment. Since Talicia maintains high eradication rates and is well tolerated regardless of a patient's diabetes, it represents a rational empiric first-line choice for the treatment of H. pylori infection."
Poster two (poster number: Tu1077): Low-Dose Rifabutin Triple Therapy Demonstrates High Helicobacter pylori Eradication Rates: Physiologically-Based Pharmacokinetic (PBPK) Modeling Supports Favorable Intragastric Rifabutin Concentrations for 50 mg Q8H Dosing vs. 150 mg QD
Presenting Author: Dr. Colin W. Howden, MD, Professor Emeritus, University of Tennessee Health Science Center.
Sufficient intragastric antibiotic exposure is critical for eradication of H. pylori. Consequently, understanding the influence of antibiotic dosing on intragastric exposure is imperative. This study used PBPK modeling to compare intragastric rifabutin concentrations with Talicia (low-dose rifabutin 50 mg) administered every 8 hours (Q8H) vs. rifabutin 150 mg (the generically available dose) administered once daily (QD). Intragastric rifabutin concentration time above the mean inhibitory concentration (MIC90 = 0.008 mcg/mL) was calculated over a 24-hour period for each regimen. Low-dose rifabutin 50 mg Q8H, as in Talicia, maintained intragastric rifabutin concentrations at or above the MIC90 for approximately three times longer than rifabutin 150 mg QD. When taken with food (as indicated in the prescribing information), low-dose rifabutin 50 mg Q8H, as in Talicia, provided intragastric concentrations at or above the MIC90 for about 93% of the day, compared to 35% of the day when dosed as 150 mg QD.
"Maintaining high intragastric antibiotic concentrations is necessary for successful H. pylori eradication. Dosing rifabutin at 150 mg QD does not replicate the sustained intragastric concentrations predicted with low-dose rifabutin at 50 mg Q8H. The differences in intragastric exposure seen in this study may potentially explain the lower and less consistent eradication rates seen with generic rifabutin (about 70% eradication) than seen in the Talicia clinical trial program (about 84-90% eradication)," said Dr. Colin W. Howden, MD, Professor Emeritus, University of Tennessee Health Science Center. "Given the need to aim for the most effective empiric first-line eradication therapy, it is important to utilize a therapy with the highest likelihood of H. pylori eradication success, such as Talicia."
"These important new data enhance the body of evidence supporting the use of Talicia as a first line therapy for H. pylori," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer. "Talicia consistently shows its ability to maintain high H. pylori eradication rates, even in challenging patient populations, with zero to minimal resistance. This work also demonstrates Talicia's sustained intragastric exposure, providing optimized conditions for eradication of H. pylori at the first treatment attempt."
Raleigh drugmaker pursuing Covid treatment raising $15M to fund acquisitions
https://finance.yahoo.com/m/c79ee13e-1d1a-30fa-8497-3d049a35ee8e/raleigh-drugmaker-pursuing.html?ana=yahoo&yptr=yahoo
By Zac Ezzone – Staff writer, Triangle Business Journal
May 10, 2022
A Triangle drugmaker pursuing Covid-19 treatments is raising $15 million through a direct offering with a health care investor.
RedHill Biopharma (Nasdaq: RDHL), an Israeli company that operates a U.S. headquarters in Raleigh, disclosed Monday it had reached an agreement with "a single leading health care investor" for the purchase of more than 10 million shares in a registered direct offering at $1.42 a share.
Additionally, the company agreed to issue unregistered private warrants to the investor to purchase up to more than 13 million shares at $1.48 a share in a concurrent private placement, according to a filing with the U.S. Securities and Exchange Commission. The company expects the offering to close Wednesday.
The company says that it intends to use the $15 million to support working capital, acquisitions and general corporate purposes.
RedHill's stock fell more than 30 percent Monday after the company disclosed the offering prior to markets opening. The company's shares were trading at $1.48 when the market closed Friday. By the end of Monday, the price dropped to $1.08 a share. Its 52-week high is $11.18.
The offering follows the company signing a licensing deal with the South Korean corporation Kubo Co. Ltd for the exclusive rights to commercialize RedHill's investigational Covid-19 treatment called opaganib. Through this deal, which the company unveiled in March, RedHill will receive an upfront payment of $1.5 million and is eligible to receive up to $5.6 million in milestone payments, in addition to low double-digit royalties on the net sales of opaganib in South Korea.
RedHill announced in December it has sent clinical data from a phase 2/3 study and other information on opaganib to the U.S. Food and Drug Administration and the equivalent agencies in the European Union and United Kingdom to try to advance the treatment through the regulatory process. Discussions between RedHill and these countries remain ongoing, according to the company's annual financial report released in March.
In addition to opaganib, the company is pursuing another investigational Covid-19 treatment called RHB-107, which is being developed for the treatment of non-hospitalized symptomatic patients. The company continues to advance the drug in a phase 2/3 study.
In addition to these investigational treatments and other candidates in its pipeline, the company is focused on the commercialization of three gastrointestinal-related products: Movantik, Talicia and Aemcolo. In 2021, the company generated about $76.8 million in revenue from Movantik sales, which made up most of its net revenue for the year of roughly $85.8 million. That revenue total was up 33.2 percent from 2020.
The company's expenses also rose last year. RedHill attributes an increase in research and development expenses from $16.5 million in 2020 to $29.5 million in 2021 to the advancement of its Covid-19 programs. Additionally, the company saw its selling, marking and general and administrative expenses rise from $74.7 million in 2020 to $88 million in 2021. This increase was mainly due to an expansion of RedHill's commercial operations related to Talicia and Movantik, which both launched in 2020.
The company ended 2021 with an operating loss of $81.1 million and a cash balance of $54.2 million.
RedHill Biopharma to raise $15M in equity offering
May 09, 2022 8:43 AM ETRedHill Biopharma Ltd. (RDHL)
By: Shweta Agarwal, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) announced Monday a direct stock offering to raise up to $15M in gross proceeds.
That is to come through the issue of 10.56M American Depositary Shares (ADS), priced at $1.42 each, to a healthcare investor.
In addition, the specialty biopharmaceutical company-RDHL- has agreed to issue private warrants to the investor that is equivalent to buying about 13.20M ADSs at exercise price of $1.48 each within the expiry of 5.5 years.
RedHill intends to use the net proceeds for working capital, acquisitions, and general corporate purposes.
Closing of the offering is expected on May 11, 2022.
RedHill Biopharma Ltd (NASDAQ:RDHL)
https://finance.yahoo.com/news/cathie-wood-latest-portfolio-10-152057010.html
RedHill Biopharma Ltd (NASDAQ:RDHL) is an Israel-based company which is known for its medicines for the treatment of gastrointestinal and infectious diseases. In the first quarter of 2022, Cathie Wood’s hedge fund bought 861,798 shares of RedHill Biopharma Ltd (NASDAQ:RDHL), which had a total worth of $2.17 million. RedHill Biopharma Ltd (NASDAQ:RDHL) recently announced that its investigational oral COVID therapy opaganib maintained the viability of host cells in lab studies and proved its effectiveness against the Omicron variant.
Out of 924 hedge funds in our database, just four funds had stakes in RedHill Biopharma Ltd (NASDAQ:RDHL) as of the end of the fourth quarter.
Looking forwards to Q1 results, hopefully
improved YOY results will be significant.
Regarding the seekingalpha article stated, now that the management of covid and covid patients is relatively under control for the most part in the US, one might expect that urea breath tests will be easier to execute, thus with ensuing higher sales of Talicia over the coming quarterly reports.
It was accurate for the article to state that the high (25%) percentage quarter over quarter increase in Talicia sales seen in the last earnings was due to starting from a relatively low baseline. But 25% is still a significant increase by anyone standards. As more and more physicians get used to the product and talking about it with other physicians, and of course having a satisfactory experience with the drug, then sales should keep seeing an increase in the current environment.
H.Pylori peptic ulceration is very common and a very commonly treated disease.
Talicia is hands-down the best product on the market to treat this disease. I can't see why sales shouldn't keep seeing constant increases for a good while to come.
As far as the Covid programs, both opagnib and upamostat appear to be highly efficacious and non-variant specific. I do believe that have a place in the covid treatment algorithm though I am curious to understand where they stand on all the regulatory requirements. I don't see any plans to do further Phase 3 studies so far, but they are coming out with consistent new and positive information with regards these assets.
They have a number of compelling late stage other products and I don't find them to be a financially wasteful company, and appear well able to take on the marketing of a product as evidenced by the increase in Movantik Rx since they took over the product.
Looking for consistently improving sales through the quarter and quite significant increases at that.
Perhaps on a miracle day?
Miracles have pccured in this region, although a very long time ago.
Thanks for the info, Midas!
Some day...maybe someday?
RedHill: Given Up For Dead
Apr. 30, 2022 1:52 AM ETRedHill Biopharma Ltd. (RDHL)
Summary
RedHill has had a busy pandemic which has been distressing for shareholders.
RedHill has mastered the art of tiny deals with plentiful future prospects, whether they can ever add up to anything is unsure.
RedHill's forward liquidity will be highly challenging.
RedHill (NASDAQ:RDHL) has been working mightily to establish itself as a leader in gastrointestinal (slide 5) and infectious diseases. I have been following its progress since 08/2017's "Redhill's Dilution Remedy, A Work In Process".
This article evaluates its forward prospects in light of its Q4, 2021 earnings call (the "Call") and its current travails.
COVID-19 has had a long, complex and generally negative impact on RedHill
The COVID-19 pandemic was first identified as such by the WHO on 03/11/2020. America's chief pandemic poohbah, Anthony Fauci, has recently declared that in the US the pandemic phase has finally given way; the wide incidence of the disease, coupled with vaccination and boosting has cut the number of new cases to below the level of a pandemic.
During the pandemic RedHill's shares have saw-toothed widely. They have had dramatic, and invariably short, updrafts against a horribly negative backdrop for the most recent eight months.
Chart
Data by YCharts
Its late 08/2021 spike up, as shown above, built from its Q2, 2021 earnings call. It included tantalizing tidbits on its oral sphingosine kinase-2 (SK2) COVID-19 inhibiting prospect opaganib, such as quoted below:
In parallel, our team and our partners are doing everything humanly possible to get to the finish line with opaganib's global 475 patient Phase 2/3 study in severe COVID-19. With last patient out announced last month, we are nearly there. Remarkably, this study only commenced about a year ago. It was planned and executed by RedHill and its partners at the speed of light, in pharma terms, and it was driven by the urgent medical need all around...
Subsequently, successive encouraging opaganib reports fueled its upward momentum. Everything came to a screeching halt a short month later in mid September 2021. On 09/14/2021, RedHill reported preliminary data showing that this trial did not meet its primary endpoint.
On 09/13/2021, RedHill was trading in the $7-8 range. The next day its price dropped to a high of $5.30, ranging to a low of $4.65 on a volume of over 7 million shares compared to its more normal volume, often trading <200,000 shares.
Sadly, as I write on 04/28/2022, RedHill is trading ~$1.73, not far from its 52 week low of $1.60. Today on Seeking Alpha it bears a dreaded quant warning:
When you check out the explanation, it is thoroughly daunting. RedHill has a quant system "strong sell" rating. This rating is based on RedHill's abysmal profitability ratings compared to the health care sector generally.
The pandemic has not been kind to RedHill. It has exhausted significant funds in pursuing its COVID-19 therapeutics opaganib and its Serine Protease Inhibitor upamostat (RHB-107). Neither has yet produced any product revenue nor regulatory approvals.
Additionally, the pandemic has eviscerated any potential revenues that it might otherwise have generated from its travelers' diarrhea therapy, Aemcolo; it acquired Aemcolo at just the wrong time, months before the pandemic lockdowns and travel restrictions began taking effect.
RedHill has mastered the art of small ball and visualization of a brighter future
Back in 2017, I questioned RedHill's strategy of acquiring therapies with dubious economic prospects. It didn't take long for these to prove ineffective; RedHill "abandoned its initial in-licensing foray (Donnatal, EnteraGam and others) in 01/2020".
Its replacement in-licensed therapies have shown better prospects. Movantik (naloxegol), sub-licensed from AstraZeneca (AZN) in 02/2020, has generated significant revenues totaling ~$77 million in 2021 (2021 20-F, p. F-38). In-licensed Aemcolo and Talicia (developed by RedHill), have combined to contribute ~$9 million.
Talicia's actual revenue contribution is a mystery. We do know from the Call that it has increased 132% over 2020 and from the 20-F that it is <$9 million, implying that the exciting percentage revenue jump is from a very small base. Talicia has also contributed an out licensing deal with a $2 million upfront license fee from RedHill's Emirates partner, Gaelan Medical. The deal calls for unspecified milestones and tiered royalties up to the mid-teens.
In addition to its Gaelan deal, the Call also included an announcement of a two part deal with Kukbo, a South Korean company, as follows:
The first part is a strategic investment of up to $10 million by Kukbo in RedHill.
The second part is the licensing agreement for opaganib for COVID-19 in South Korea, with upfront and milestone payments of up to $7.1 million plus royalties.
RedHill's Q4, 2021 earnings press release amplified on this indicating that Kukbo had already paid $1.5 million upfront for opaganib.
In addition to the two deals that it has completed, CBO Goldberg offered the following blue sky possibilities for investors to consider:
We are in active discussions for potential future licensing deals for our therapeutic products, as we're seeing an increase in interest in our pipeline. We also see interest in our commercial products and - we also have discussions ongoing to add new commercial products that would be synergistic with the products we currently promote...
During the Call, CFO Chorin further tantalized investors announcing:
...we are in intensive discussions for additional licensing and other business transaction - transactions, potentially totaling dozens of million dollars, which together with our continued organic and non-organic growth expected in 2022 set the stage for our financial independence in the near future.
As I write on 04/29/2022, over a month after the Call, these intensive discussions have yet to generate any announced results.
RedHill's finances are complex and scary.
During the Call, RedHill announced its cash for the close of 2021 at a balance of $54.2 million. It indicated that it had reduced its cash burn, but did not indicate to what level it currently resides.
Indeed the call was replete with additional examples of incomplete financial information such as:
Reports on Talicia's growth in revenues and prescription volume without its actual revenue figures,
Report that quarterly operating expenses declined by $5.9 million in Q3, and $6.4 million in Q4, 2021, without any mention of the amount of such expenses.
Although not in the Call, more information is available. As an Israeli company, RedHill files no 10-K. It does however file a less familiar but analogous 20-F as cited above. At page 12 of its 20-F, RedHill recites a familiar litany of risks of the sort that stalks many if not most development stage biotechs.
In RedHill's case these include, among others:
Accumulated losses to date of $367.9 million,
Recent annual net losses of approximately $97.7 million in 2021, $76.2 million in 2020, and $42.3 million in 2019,
Except for its already approved Talicia, its remaining late stage pipeline candidates "will likely require successful additional clinical trials" before regulatory approval,
Its restricted cash of $16 million as required by its credit agreement with HCR Collateral Management, LLC ("HCRM").
In its Liquidity and Cash Resources section of its 20-F, RedHill reveals a number of nagging obligations which will pose recurring challenges for its ongoing cash flow including:
Remaining payment to AstraZeneca of $7.5 million by 12/31/2022,
Payments to Daiichi Sankyo of $5 million in July of 2022 and 2023,
Miscellaneous milestones for various of its pipeline candidates acquired in earlier deals,
Payments totaling at least $22 million prior to 2025 for Movantik inventory,
Miscellaneous Movantik royalties.
To this point RedHill has been financing its significant ongoing cash need with ATM sales of its stock. These include three 2021 offerings totaling ~$72 million at prices ranging from $7.84 (~3.2 million shares - 01/14/2021), to $8.00 (~4.6 million shares - 03/04/2021) to $3.20 (~4.7 million shares - 11/18/2021).
It took about 12.5 million shares to generate the ~$72 million. At its current (04/29/2022) price of $1.68 per share, it would take ~$43 million shares to generate $72 million.
Conclusion
RedHill management has proven itself resourceful in coming up with sundry deals over the years. Optimists can take heart that management may forge a new deal that will protect it from its otherwise bleak future.
Ever the optimist, I am hopeful that such will be the case for RedHill. As a realist, I have to rate RedHill as a sell.
This article was written by
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Writing under the pseudonym "out of ignorance", I very much regard investing as a learning process. Investing failures are tuition paid. Investing successes enter the trove of lessons learned. In my Seeking Alpha articles I share my experience from decades of investing and from ~5 years of focused research on a variety of stocks, in recent years with a primary emphasis on healthcare stocks. I greatly appreciate those who take the time to share their reactions to articles, particularly those who share relevant anecdotes and experiences.
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ATHX popped today. RDHL isn’t far behind. We may double any day
RedHill Biopharma Ltd Announces Potent Omicron Inhibition with RedHill's Opaganib
https://finance.yahoo.com/news/redhill-biopharma-ltd-announces-potent-120200639.html
Oral opaganib's reported potent in vitro activity against Omicron adds to previously observed inhibition of Delta and other SARS-CoV-2 variants of concern that cause COVID-19; Testing conducted by The University of Hong Kong School of Public Health, a world renowned WHO collaborating center
Based on the new and previously announced data, opaganib's unique human host-targeted, dual antiviral and anti-inflammatory suggested mechanism is expected to act independently of viral spike protein mutations and remain effective against Omicron sub-variants BA.2, XE and other emerging and future variants
Previously reported phase 2/3 clinical data showed reduced mortality in key subpopulations, improved viral RNA clearance, and faster time to recovery for moderate to severe hospitalized patients treated with opaganib
Regulatory submissions and discussions in the U.S., Europe, UK and additional countries are progressing regarding confirmatory data requirements and pathways to potential approval
TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / April 11, 2022 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced study results in which opaganib (ABC294640)[1], a leading oral drug candidate for hospitalized patients with moderate to severe COVID-19, was observed to have potent in vitro efficacy against the Omicron SARS-CoV-2 variant, while maintaining host cell viability. Based on the new and previously announced data, opaganib's unique human host-targeted, dual antiviral and anti-inflammatory suggested mechanism is expected to act independently of viral spike protein mutations and remain effective against Omicron sub-variants BA.2, XE and other emerging and future variants.
Work on testing opaganib against Omicron was conducted by the Centre for Immunology and Infection (C2i), The University of Hong Kong's world-renowned infectious diseases research center, School of Public Health, by Dr. Michael Chan, Principal Investigator, of the Centre for Immunology and Infection, who said: "The results of this study showed opaganib exerting potent inhibition of Omicron SARS-CoV-2 variant viral replication in a model that we believe comes as close as currently possible to representing the Omicron clinical pathophysiological pathway. These are highly promising results that lend further weight to opaganib's hypothesized host-mediated antiviral activity and expected effect irrespective of viral variant."
"Opaganib was tested for inhibition of Omicron SARS-CoV-2 viral replication using an ex vivo human respiratory explant model, a methodology based on the finding that Omicron has a replication advantage in respiratory tract explants culture," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "The results of the study, led by Dr. Chan, one of the leading experts in the field who's extensive COVID-19-related research is widely published in top tier journals such as Nature, are encouraging. The results are also consistent with findings from the Phase 2/3 study in which opaganib was shown, together with reducing mortality in key subpopulations and improving the time to recovery, to accelerate viral RNA clearance by more than 4 days, even in an advanced patient population with a median of 11 days from onset of symptoms - we believe a likely first for a novel oral therapy in this underserved hospitalized moderate to severe COVID-19 patient population."
Opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840). In a prespecified analysis of all Phase 2/3 study patients with positive PCR at screening[2], opaganib improved the median time to viral RNA clearance by at least 4 days, achieving viral RNA clearance in a median of 10 days, while the median for clearance was not reached by the end of 14-days treatment in the placebo arm (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463). Additional prespecified analyses in key subpopulations from the Phase 2/3 study also demonstrated a 70% reduction in mortality and a 34% benefit in time to recovery for patients treated with opaganib.
Regulatory submissions and discussions in the U.S., Europe, UK and additional countries are progressing regarding confirmatory data requirements and pathways to potential approval.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with suggested dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and, based on data accumulated to date, is expected to maintain effect against emerging viral variants, having already shown in vitro inhibition against variants of concern, including Omicron and Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
In prespecified analyses of Phase 2/3 clinical data, oral opaganib has demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations. Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[3].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
RedHill Biopharma Ltd
RedHill Biopharma Ltd
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 adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. 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 2/3 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 the plan for and timing of potential emergency and marketing authorization applications in certain ex-U.S. countries. 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 including, without limitation that opaganib will not also maintain similar levels of clinical activity against Omicron sub-variants BA.2, XE and other emerging and future variants, the Phase 2/3 COVID-19 study for opaganib and its results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that emergency and marketing authorization applications in certain ex-U.S. countries will be delayed, that opaganib will not be effective and will not be as effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, 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 preclinical studies or clinical trials (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 Movantik®, 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 and sustain 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, preclinical 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 commercial products 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 events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. 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 & 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
Category: R&D
[1] Opaganib is an investigational new drug, not available for commercial distribution.
[2] Positive PCRs at screening obtained for 437 out of 463 patients - remaining patients could not be included in this prespecified analysis due to lack of PCR results at screening
[3] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.
[4] Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.
[5] 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.
[6] 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.
This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
SOURCE: RedHill Biopharma Ltd.
View source version on accesswire.com:
https://www.accesswire.com/696867/RedHill-Biopharma-Ltd-Announces-Potent-Omicron-Inhibition-with-RedHills-Opaganib
RedHill featured on the Closing Bell program
RedHill’s (Nasdaq: RDHL) Chief Business Officer, Guy Goldberg, was interviewed last night on the Cheddar News Closing Bell program by anchor Kristen Scholer, a former WSJ columnist and CNBC producer. First questions were about RedHill’s COVID-19 development programs and the last question was about RedHill’s commercial progress. To watch the interview please click on the link below:
https://cheddar.com/media/redhill-biopharma-has-two-covid-19-drugs-in-clinical-trials-in-hopes-of-making-more-treatments-available
Meet us at the 2022 #BIOEUROPESPRING Digital Conference next week to discuss potential #partneringopportunities with #RedHill! Visit our website for additional details: https://bit.ly/3D9BB3g
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As of 09:54AM EDT. Market open.
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RedHill Biopharma Ltd. (RDHL) CEO Dror Ben-Asher on Q4 2021 Results - Earnings Call Transcript
Mar. 17, 2022 3:03 PM ETRedHill Biopharma Ltd. (RDHL)
RedHill Biopharma Ltd. (NASDAQ:RDHL) Q4 2021 Earnings Conference Call March 17, 2022 8:30 AM ET
Company Participants
Alexandra Okmian Sanderovich - Senior Business Development and Investor Relations Manager
Dror Ben-Asher - Chief Executive Officer
Guy Goldberg - Chief Business Officer
Gilead Raday - Chief Operating Officer
Rob Jackson - Senior VP, Sales & Marketing
Micha Ben Chorin - Chief Financial Officer
Conference Call Participants
Brandon Folkes - Cantor Fitzgerald
David Hoang - SMBC
Boobalan Pachaiyappan - H.C. Wainwright
Operator
Good day and welcome to the RedHill Biopharma’s Fourth Quarter and Full Year 2021 Financial Results Conference Call. All participants are in a listen-only mode. After the speakers’ presentation, there’ll be a question-and-answer session. [Operator Instructions]
At this time, I would like to introduce the conference call, RedHill’s CEO, Dror Ben-Asher; Guy Goldberg, Chief Business Officer; Gilead Raday, Chief Operating Officer; Rob Jackson, Senior VP Sales & Marketing; Rick Scruggs, Chief Commercial Officer; and Micha Ben Chorin, Chief Financial Officer. We have additional senior management team members available to answer questions during the Q&A session, including; Dr. June Almenoff, Chief Medical Officer; and Dr. Mark Levitt, Chief Scientific Officer.
I will now turn the call to Dror Ben-Asher, RedHill’s CEO.
Dror Ben-Asher
Thank you, Alexandra. Good day, everyone and thank you for joining our fourth quarter and full year 2021 earnings call, during which we’ll be presenting R&D commercial and financial highlights. First and foremost, we’d like to thank the entire RedHill team for their remarkable achievements in the last year.
Against the pandemic backdrop, the RedHill team delivered the record revenue and first positive commercial operations contribution in the fourth quarter of 2021. A strong fourth quarter for both Talicia and Movantik coupled with disciplined cost efficiency measures and intensive out-licensing and in-licensing activities, set us up for rapid organic and non-organic growth in 2022 and beyond. Rob Jackson, who is heading our Marketing & Sales will further elaborate shortly.
Turning to R&D. RedHill remains at the forefront of the global search for much needed novel oral COVID-19 therapies, particularly so given the frequent emergence of new variants such as Omicron and most recently, BA.2. Our highly capable R&D team has delivered exciting efficacy data with both opaganib and RHB-107, our variant-agnostic investigational oral novel oral candidates for the treatment of hospitalized and non-hospitalized COVID-19 patients. At the same time, our ongoing Phase 3 study with RHB-204 is the most advanced first-line standalone potential treatment for NTM infection is being accelerated. Gilead Raday, our Chief Operating Officer will elaborate about our R&D programs shortly.
I will now be turning to Chief – to our Chief Business Officer, Guy Goldberg and the team for our presentation to be followed by a Q&A session.
Guy Goldberg
Thank you, Dror. We’ve started off the year strongly and are poised for successful 2022 with our seasoned commercial team leading the way, we’re expecting commercial operational profitability in 2022. This would mark a major milestone for the company. We will get to this important milestone by growing revenues through our strengthened salesforce, being cost efficient and maintaining disciplined cost-control measures.
We look back on 2021 with a lot of pride that what we were able to accomplish. Our commercial operations had a net positive contribution in Q4 for the first time and recorded annual and quarterly revenues of $85.8 million and $22.1 million. This success was driven by our two main revenue generating products.
First, Talicia for H. pylori infection. Talicia became the most prescribed branded H. pylori therapy in December. And already, we are seeing a nice growth trajectory this year. Talicia has enormous potential for patients and is a value driver for RedHill as a company. As with almost all launches we continue to advise that it takes time to build awareness and acceptance, both with payers and also with physicians.
Second, Movantik for opioid-induced constipation. Movantik prescriptions are up as well as we saw quarter-over-quarter growth. We continue to maintain a market leadership position and that PAMORA class of drugs as a whole continued to rebound. Movantik is well liked by physicians, it has great reimbursement, great efficacy and safety and great brand recognition and satisfaction. There’s still a very large and underserved OIC patient population. RedHill continues to improve Movantik’s status as best unrestricted coverage in the PAMORA class.
Our cash position as of the end of 2021 was $54.2 million. We also have had successful transactions and expect to see continued success on this front in 2022. There are two recent transactions to note here. First, with Kukbo, a South Korean company we announced the two-part transaction. The first part is a strategic investment of up to $10 million by Kukbo in RedHill.
The second part is the licensing agreement for opaganib for COVID-19 in South Korea, with upfront and milestone payments of up to $7.1 million plus royalties. The second transaction we announced was a licensing agreement for Talicia with Gaelan Medical in the United Arab Emirates. The agreement included a $2 million upfront payment to RedHill and milestone payments and tiered royalties up to mid-teens on net sales.
We are in active discussions for potential future licensing deals for our therapeutic products, as we’re seeing an increase in interest in our pipeline. We also see interest in our commercial products and – we also have discussions ongoing to add new commercial products that would be synergistic with the products we currently promote. This would enable us to leverage the great commercial operation we have built and benefit from economies of scale.
This slide shows our R&D highlights. Gilead will go into detail on the data. One point I want to emphasize is that, despite some of the infection rate declines seen in the US and elsewhere recently, COVID continues to be an important field of drug development for two reasons. First, it is an ongoing and future public health threat with a huge unmet medical need. And also second, it has shown to be a very large, relatively undeveloped market opportunity.
On the first point, we should remember this pandemic is not over. And it’s one of the biggest public health crisis the world has faced in the last 100 years, and it is still here, not just with the threat of future numerous mutations that can overcome and overwhelm vaccine and natural immunity. But also with the strain circulating now.
There have been over 11 million newly reported COVID-19 cases globally in just the last seven days, predominantly from Asia and Europe, and there have been over half a million deaths globally since Omicron is detected according to the World Health Organization. Public health officials have been saying loud and clear that a simple, scalable, effective and safe therapeutic is desperately needed.
On the second part, COVID therapeutic market continues to prove that it is very large. Pfizer said in its earning announcement last month that expects Paxlovid sales to be worth an enormous $22 billion for 2022. And just last month, Eli Lilly announced a supply agreement with the US government for its COVID-19 antibody for $720 million. We are firm believers in our COVID program and we think their unique mechanism of action puts us at the forefront of development in this field.
To remind our audiences of our two novel oral COVID-19 programs for opaganib, our novel orally-administered first-in-class SK2 inhibitor, addressing moderately severe inpatient hospitalization, with its method of action targeting the host cell rather than working on the virus directly, we believe we can cast a wider net of efficacy against emerging variants, and Gilead will go into the details of this data later.
Second, we have RHB-107, an orally-administered inhibitor of S1 family of trypsin like serine proteases being developed as a treatment for non-hospitalized COVID-19 patients. Importantly, RHB-107 is also once-daily oral pill and it’s also host-mediated, which means, that it should also potentially work against various mutations.
Our recent data has shown 100% reduction in COVID-19 related hospitalization and an 88% reduction in reported new severe COVID-19 symptoms after treatment initiation. As mentioned previously, we’re seeing growing interests from potential partners for our R&D products, especially opaganib, RHB-107 and RHB-204.
This slide shows our full commercial and R&D pipeline, a brief overview of RedHill for those new to the story who may be on the call today. At the top of the slide, you see the 3 FDA approved products we promote, Movantik for opioid-induced constipation, Talicia for H. pylori infection and Aemcolo for travelers’ diarrhea caused by non-invasive strains of E. coli.
Our commercial products are a mix of products we develop in-house like Talicia and products brought in externally like Movantik which we got from AstraZeneca and Aemcolo which we got from Cosmo. I would note that with the pandemic receding for now in the US, we will put renewed vigor into our Aemcolo product which we think is a great product.
The second part of the slide shows the multiple late-stage programs in development, addressing important unmet medical needs. We have generated lots of data with many different drug candidates in many therapeutic areas, other than the ones we’re discussing today on the call. These products include RHB-104 for Crohn’s, BEKINDA for gastroenteritis and IBS-D, and RHB-106 for bowel prep candidates.
I will now turn it over to Gilead for a discussion of R&D.
Gilead Raday
Thank you, Guy. In the following slides, I will provide a brief update on some of our leading R&D programs. Opaganib is our oral pill which is a first-in-class proprietary selective sphingosine kinase 2 inhibitor. Through inhibiting this host enzyme, opaganib exerts a dual action against COVID-19, inhibiting viral replication on the one hand, and reducing the body’s excess immune response to the infection on the other hand. Given its unique mechanism of action, opaganib is currently positioned to target advanced COVID-19 infection in hospitalized patients with moderate to severe COVID-19 pneumonia.
Following the promising data from the global Phase 2/3 study in hospitalized patients, we are in ongoing regulatory discussion about the path forward in multiple territories worldwide. Opaganib development is also being continued in oncology indications with cholangiocarcinoma Phase 2 top line data expected in Q2 2022.
RHB-107 is our second advancing COVID-19 oral pill candidate. RHB-107 is positioned to treat early-stage mild to moderate COVID-19 infection through targeting serine proteases, which are host enzymes involved in viral replication. We recently announced positive and promising results from part A of a Phase 2/3 study in non-hospitalized symptomatic COVID-19 patients that show [technical difficulty] potential capacity to prevent deterioration with excellent safety and tolerability.
Together, opaganib and RHB-107 cover the broad spectrum of COVID-19 patients from early-stage mild patients to advanced severely ill hospitalized patients. Both products are oral pills and are not affected by viral mutations to the spike protein. As such, they are both highly promising products for tackling and merging variants of concern.
The importance of our products’ capacity to address new variants of concern via our mechanism of action, which is independent of the spike protein is highlighted by a recent publication in nature which claims that the lower severity of Omicron is coincidence, and that ongoing rapid antigenic evolution is likely to produce new variants that may escape immunity and be more severe. RedHill is holding two promising products that could serve as important tools in responding to future pandemic waves.
RHB-204 is the most clinically-advanced standalone oral therapy in development for first-line treatment of Pulmonary tuberculous Mycobacteria – Nontuberculous Mycobacteria. The ongoing Phase 3 study is progressing and we expect enrollment in the study to pick up with the current waning in COVID-19 infections in the US. Overall, we see strong interest from the industry and potential partners in these promising R&D programs. I will highlight further details regarding each program in the next few slides.
Opaganib’s clinical data package has been submitted to several regulatory agencies. Initial guidance requiring confirmatory data on past to potential approval has been received from the EU’s EMA, the US FDA and UK’s MHRA. Communication with these agencies continues. Various types of regulatory submissions and regulatory interactions are also ongoing in several additional countries worldwide. The type of regulatory submission depends on the relevant and often significantly varying regulations in each country. As a reminder, the global Phase 2/3 study met part of this pre-specified endpoints.
The study showed a 70% reduction in mortality for opaganib when given on top of remdesivir and corticosteroids. Less than 7% mortality in the opaganib arm versus over 23% mortality in the placebo control arm with a p value of 0.034. Opaganib also provided a 34% benefit in time to recovery by Day 14 with a p value of 0.013. Additionally, opaganib improved the median time to viral RNA clearance by at least 4 days with a hazard ratio of 1.34 and nominal p value of 0.043.
Further post hoc analyses showed a marked benefit in reducing mortality with a 62% reduction in a large subpopulation of over half of the study participants, which consisted of moderately severe hospitalized COVID-19 patients. This promising overall data in advanced hospitalized patients underscores our plans to advance developments of opaganib for treating the appropriate patient population.
The accumulated data with opaganib for COVID-19 from both the US Phase 2 study and the global Phase 2/3 study point towards the moderately severe patients as an underserved patient population with high unmet need that could potentially benefit greatly from opaganib. This chart illustrates qualitatively who these moderately severe patients are. The horizontal axis shows the WHO Ordinal Disease Severity categories for hospitalized patients, and the Y axis is a Qualitative Continuous Severity Spectrum.
Looking at the WHO Ordinal Scale categories, moving from category 3, which is hospitalized with no supporting oxygen to category 4, which is hospitalized with low flow oxygen support devices, to category 5 patients who are hospitalized and receiving high flow oxygen support over to category 6, which have been incubated and are mechanically ventilated. There is some overlap in actual disease severity across the disease different categories.
The patients who have the potential to benefit most from opaganib those moderately severe patients who are in need of oxygen support due to the deteriorating condition, whether they are connected to low flow or high flow oxygen devices, up to a certain disease severity beyond which the benefit is likely diminished. We have identified that the fraction of inspired oxygen administered to patients, FiO2 in short, is closely related to underlying disease severity. And this measure enables us to identify the target population likely to benefit most, highlight in the chart in the light blue area.
These category four or five patients have a high unmet medical need, and there is still no highly effective therapeutic treating them and represent the majority of hospitalized COVID-19 patients. Milder hospitalized patients are also likely to benefit from opaganib as a result of its antiviral activity.
Given opaganib’s potential broad antiviral activity, opaganib is continuing to be developed pre-clinically in collaboration with NIH for also treating additional viral infections such as Chikungunya virus, RSV and Ebola. Previous data has indicated opaganib’s capacity to inhibit Ebola virus replication, and also Chikungunya virus replication. We are also continuing to advance opaganib’s development program in oncology and inflammatory indications with Cholangiocarcinoma Phase 2 study top line analysis expected in Q2 2022.
As recently announced, RHB-107 or upamostat as we call it, provided positive top line results from Part A of the Phase 2/3 study in outpatients in the US. Part A met the primary endpoint of safety and tolerability. Moreover, Part A provided highly promising efficacy results despite its small sample size of 61 subjects. We saw a 100% reduction in COVID-19 related hospitalizations with zero out of 41 patients who were treated with RHB-107 versus 15% of patients on the placebo control arm requiring hospitalization.
There was also an 88% reduction in reported new severe COVID-19 symptoms after treatment initiation. Only one RHB-107 patients out of 41 equating to 2.4% reported new severe COVID-19 symptoms. This versus 20% of patients reporting new severe COVID symptoms in the placebo control arms. Importantly, for early-stage COVID-19 infected patients RHB-107 presents a highly favorable profile. It is taken orally once a day as a standalone treatment with excellent safety and tolerability and with no major drug-drug interactions limiting its potential use. Given the promising outcomes, work is underway to complete data analysis and submit to regulatory agencies for moving into Phase 3 study.
RHB-204 is the only first-line standalone oral treatment in late-stage clinical development for pulmonary NTM disease caused by Mycobacterium avium complex or MAC. A rare condition with no FDA approved first-line therapy. This underscores our focus on this program, advancing the ongoing US Phase 3 study in NTM towards potential NDA. We are expecting enrollment to pick up with the waning of COVID-19 in the US and the expansion of study participating sites.
As a reminder, the study is randomized, placebo controlled and has a six months co-primary endpoint of sputum culture conversion, abbreviated SCC, and clinical benefit using patient reported outcomes. After the first six months, study subjects crossover to open label active treatment with RHB-204 for an additional 12 months from conversion in accordance with clinical practice. Of note, RHB-204 has been granted Orphan Drug designation and QIDP status, providing for expedited development, priority review of the NDA and 12 years market exclusivity from approval, underscoring significant market potential for the program.
I will now turn it to Rob Jackson for an update on our commercial program.
Rob Jackson
Thank you, Gilead and good morning. Over the next few minutes, I’m going to summarize the progress we made during the fourth quarter with our sales, marketing and market access activities, so that you can all better understand why we feel increasingly confident about where our business is heading in 2022. Before I begin, I’d like to recognize the efforts of our RedHill colleagues, especially the Field Sales Team, as we all strive to deliver consistent profitable growth. Thank you everybody at RedHill for all of your contributions.
During the fourth quarter, RedHill achieved record quarterly prescription volume for both Talicia and Movantik. RedHill grew Talicia prescription volume by 25.5% over third quarter, delivering 10 point improvement in quarter-on-quarter growth. Additionally, Talicia prescription volume has now surpassed [pylori] [ph] establishing Talicia the most prescribed branded H. pylori therapy in the United States.
This is strong and growing evidence that payers and prescribers increasingly recognize Talicia’s ability to overcome the combined challenges of clarithromycin resistance, H. pylori regimen tolerability and diminishing efficacy, issues that first rated prescribers and patients every day, while consuming valuable healthcare resources.
Simultaneously RedHill grew Movantik prescription volume by 2.4% over the third quarter, and our fourth quarter results represented our best quarterly performance with Movantik since we acquired commercial rights from AstraZeneca in first quarter of 2020. We continue to maintain overwhelming market share with Movantik and clear market leadership of the PAMORA class.
Our two lead brands are well positioned to continue these performance trends into 2022. And additionally, we continue to explore opportunities to expand our portfolio and add synergistic products that complement our current salesforce focus in the Pain and GI segments.
During the fourth quarter, RedHill grew Movantik volume by 2.4% over third quarter, and that fourth quarter volume represented a 9% improvement over what we achieved in first quarter of last year. We achieved this growth by continuing to take a disciplined approach in focusing on target prescribers in the Pain Specialty segment. In tandem, we also executed marketing strategies focused on growing the PAMORA market.
This is a key objective for Movantik as the established market leader and we invested to raise OIC awareness with patients and prescribers and also to educate potential customers about how Movantik can provide relief from the symptoms of opioid-induced constipation. During the fourth quarter, we continue to achieve significant market access – success with key payers and we believe this will yield additional growth for Movantik during 2022.
As I just mentioned, RedHill has invested to grow the PAMORA market and looking at the 12-month moving annual total of PAMORA prescriptions, the clear trend of market growth has emerged over the past two quarters. This is a significant change for the PAMORA class and it reflects RedHill’s investment in building awareness of opioid-induced constipation, an encouraging provider-patient conversations. Movantik is the clear market leader and Movantik will disproportionately benefit from more patients being treated with PAMORA agents.
Recently, CDC announced draft revisions to their 2016 opioid prescribing guideline. This new guideline is expected to provide further support for opioid use in patients experiencing chronic pain. In fact, one of the reported intents of the revised guideline is to address the misapplication of the 2016 guideline. The proposed CDC guideline is currently open for public comment and CDC expects to publish their final guidance by the end of this year. It remains to be seen but the new guideline may relax some portions of the 2016 guideline resulting in a potential increase in responsible opioid prescribing and a subsequent increase in demand for PAMORA agents.
So to summarize for Movantik, we continue to achieve new milestones with this brand. We had close to 115,000 prescriptions in fourth quarter of 2021. This was our best quarterly performance since we acquired the rights to this product. Movantik also maintains its competitive advantage of having best-in-class payer coverage close to 90% of insurance plans provide access for Movantik today, and since launch more than 3 million Movantik prescriptions have been dispensed.
Simultaneously, Talicia continue to achieve new milestones and in fourth quarter, Talicia achieved its best ever performance in terms of prescription volume and market share. RedHill also achieved further improvements in customer access, which in turn enabled greater trial and usage of Talicia. With solid field execution, we believe these trends will continue and accelerate in 2022.
In the fourth quarter, Talicia achieved 25.5% prescription growth and we’re optimistic this growth will continue into this year as recent payer wins take effect, new payer wins come to fruition and field execution continues to strengthen. Antimicrobial stewardship is a very important issue. And when the most effective antibiotics are used first-line, they provide the best chance for cure, while eliminating the need for second, third and even fourth lines of treatment. And these growing realizations are enabling Talicia to achieve record performance for weekly, monthly and quarterly volume.
On the payer front, our Market Access team has continued to improve our already competitive position with commercial payers, and it’s covered in our third quarter call effective January 1st of this year, Talicia has now become available to 14 million Medi-Cal beneficiaries as a preferred brand with no restrictions. We believe this will help RedHill accelerate Talicia uptake in what is the second largest individual state for H. pylori infections and treatments.
This is another sign that healthcare experts increasingly recognized, first, the challenges of clarithromycin resistance that are currently outlined by the American College of Gastroenterology’s 2017 guidelines. And second, the pitfalls of continuing to persist with using clarithromycin-based therapy as a first-line treatment choice.
To summarize, Talicia continues to achieve new milestones, we had record prescription volume again driven by 25.5% growth in the fourth quarter, we surpassed pylori for the first time to become the most prescribed H. pylori agent in the United States and our coverage continues to improve including the addition of Medi-Cal Rx coverage which became effective in January of this year. We also continue to promote Aemcolo to consumers, primary care physicians in – gastroenterologists and our mid-term expectations are optimistic as international travel begins to return and we continue to explore new avenues for success with this brand.
In closing, we finished the fourth quarter with a consistent trend of delivering growth for both Talicia and Movantik. As the market leader in the PAMORA class, we demonstrate our ability to continue to grow new Movantik prescriptions, prescription volume in the PAMORA class and further improve on our already strong Movantik payer coverage.
We also achieved 25.5% quarter-on-quarter growth in Talicia prescription volume and became the leading branded H. pylori agent in US market. And Talicia also achieved a preferred unrestricted position on the Medi-Cal Rx formulary, which covers 14 million beneficiaries. We look forward to further growing our business during 2022.
Thank you, and I’ll turn the call back to our CFO, Micha Ben Chorin.
Micha Ben Chorin
Thank you, Rob. Good morning, good afternoon everybody. RedHill is executing on consistent growth and value creation strategy, which facilitate achieving positive contribution of our commercial operations segment for the first time in Q4, and which is expected to continue to grow in 2022 and reach profitability.
We have achieved another quarterly and annual record of net revenues accompanied by reduction in cash burn, which resulted in cash balance of $54.2 million as of December 31st, 2021. All these against pandemic headwind.
Net revenues were $22.1 million for the fourth quarter of 2021. The third consecutive quarter of record net revenues, attributable to an increase in revenues from both Talicia, 132% growth over previous year and Movantik. We generated an annual record of $85.8 million in net revenues for 2021.
The record net revenues also contributed to an annual record of non-GAAP gross margin of 53% coupled with disciplined cost control measures across the business which we are committed to continue in 2022 resulted in quarterly reduction of $6.4 million in operating expenses in Q4, following previous reduction of $5.9 million from Q2 to Q3, signaling a path towards commercial operations profitability this year.
We have signed a strategic investment agreement of up to $10 million with our South Korean Partner, Kukbo, which comes on top of the recently announced $1.5 million upfront opaganib license fee and the $2 million upfront Talicia license fee from our Emirates partner, GAG.
Importantly, we are in intensive discussions for additional licensing and other business transaction – transactions, potentially totaling dozens of million dollars, which together with our continued organic and non-organic growth expected in 2022 set the stage for our financial independence in the near future.
I will turn our discussion back to Dror to questions.
Dror Ben-Asher
Happy to take questions. Thank you.
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] Your first question today comes from the line of Brandon Folkes from Cantor Fitzgerald. Please go ahead. Your line is open.
Brandon Folkes
Hi, thanks for taking my question. Dan, congratulations on all the progress. Maybe just firstly on opaganib. Can you just help us characterize the size of the South Korea opportunity currently? And whether yourself or your partner is going to be required to run additional trials there? And then maybe along the similar lines you know should we expect potentially more partnerships on opaganib before running any additional trials? I’d love to just get your thoughts there. And then maybe the other side of business development. In terms of bringing in additional assets, should we think of these as commercial assets? Or would you look at earlier-stage assets as well? Thank you very much.
Dror Ben-Asher
Thank you, Brandon. I’ll answer the last question first and then refer to Gilead. So, we are looking at commercial assets. FDA approved our focus to the US, we have 120 customer-facing salespeople and we can handle additional products and capitalize on economies of scale. So the short answer is, we are looking at commercial assets that are synergistic to our commercial basket our existing one. And we are very well positioned to complete such transactions, in-licensing transaction in the coming months. We have several ongoing, we are cautiously optimistic.
Gilead Raday
Thank you, Dror. With regards to opaganib and future regulatory approaches, we are working in multiple territories worldwide, and some of them as you mentioned in Korea, there is a partner involved and we are working collaboratively to advance regulatory approaches there. In other territories, different regulations and requirements, require different approaches and we are adjusting to each territory in order to – and approaching each territory with the required dossier and plans in order to move forward as effectively as possible in every territory.
Dror Ben-Asher
I might add about the market in South Korea, you asked about that. We have received the market analysis from our partners, we are not authorized to share unfortunately, but it’s public information that in March alone, approximately 4 million new infections happened in South Korea and we are in mid-March. So, half a month with 4 million infections. That’s a big market and a big concern. Regarding the regulatory part, the same thing, our partner has analyzed that, they will get closely with the regulatory consultants. We are supporting that we are not authorized to see their regulatory analysis, but Kukbo, our partner are optimistic. I hope this helps.
Brandon Folkes
It is very helpful. Thank you very much and congratulations on all the progress.
Operator
Thank you. [Operator Instructions] Your next question comes from the line of David Hoang from SMBC. Please go ahead. Your line is open.
David Hoang
Hi, thanks so much for taking the questions. I had mostly a few on the commercial portfolio. So just first you know in terms of Talicia, it’s great to see the – you know the growth in quarter-over-quarter scripts. I’m just wondering, though, in terms of translation to the bottom line, I think you know it’s about 2% quarter-over-quarter revenue growth if I – you know if I did the math correctly there. And so is that – you know, do you, I guess a few questions here. Is there any change to gross to net for the product? And then do you expect sort of this – you know this relationship to persist into 20 – you know through the bulk of 2022?
Dror Ben-Asher
Thank you, David. This is Dror, I’ll refer this to Micha, our CFO.
Micha Ben Chorin
Thank you, David. So Talicia is growing in increased pace, which we are very happy with. So, we set up in penetration into new prescribers all the time. And we believe that this growth that you currently see, we will continue to see and even more.
David Hoang
Okay, great. Maybe just you know a related follow-up question. So I know you’re not – you don’t give guidance, but in terms of you know full year 2022 and you know maybe next few years just in terms of the cadence of Talicia growth? You – you know do you expect kind of a continued linear trend? Or should we expect more you know of I guess you know an inflection as we enter the second full year of Talicia sales?
Dror Ben-Asher
Yeah it’s a good question. A lot has to do with a pandemic, because until very recently, the pandemic’s impact on prescriptions in GI generally and specifically, H. pylori has been very negative and consistent for the last two years. We are seeing a rapid improvement in access to clinics, both for patients and also for on field sales. So we do expect rapid increase and rapid improvements that will be constant. That said, perhaps our Chief Commercial Officer, Rick Scruggs would like to add some color.
Rick Scruggs
Thanks, Dror. It’s a good question. We have seen in the past you know the effects of the pandemic and our ability to see healthcare providers, we have addressed that, we have initiated and created a new department in our company, it’s Customer Engagement Specialist, and they reach out to physicians who now like to be seen via video, maybe not necessarily in person. So this group is out there working with physicians in the new modality they like to be called upon.
And as you’ve seen by our nice growth in fourth quarter, we’re now the number one prescribe branded product in the category and we’re moving to teach physicians, to teach healthcare providers that Talicia is the best choice. It’s better than anything that’s available to treat H. pylori. So we’re going to see that, we’ve seen the growth now in first quarter and we anticipate to have a really good year with Talicia in 2022 and beyond.
David Hoang
Okay, I appreciate that. And then maybe you know one last one if I may and changing the topic here to the NTM RHB-204 study. In terms of the – you know the endpoint there, I know it’s the six month sputum culture conversion. Is that – you know is that sufficient to gain a full approval there or do you expect accelerated approval with the need to do a confirmatory study down the line?
Dror Ben-Asher
Thanks, David. We would like to add a couple of sentences about the previous question. And then I’ll refer to Gilead for the question about 204 for NTM. Micha, please.
Micha Ben Chorin
Hi, David this is again, Micha here. Just wanted to add with respect to your previous question, that we saw a growth of 17% on Talicia revenues between Q4 and Q3 of this year, which is substantial.
Gilead Raday
Thank you. Regarding NTM and the study, yes, you’re correct, we expect the primary endpoint at six months, where we’re looking at sputum culture conversion and a co-primary of patient reported outcomes to potentially support accelerated approval. We’ve continued evaluation of the longer-term treatment of up to 12 months post-conversion to eventually support the full dossier.
David Hoang
Okay. Thanks for taking the questions.
Gilead Raday
Thank you.
Operator
Thank you. [Operator Instructions] Your next question comes from the line of Boobalan Pachaiyappa [sic - Boobalan Pachaiyappan] from H.C. Wainwright. Please go ahead. Your line is open.
Boobalan Pachaiyappan
Hi, this is Boobalan. Thanks for taking my questions and congrats on all the great progress. So few from us. Firstly, with respect to opaganib for COVID-19, have you conducted any European-based market research study regarding potential positioning of opaganib?
Gilead Raday
Thank you. We see COVID-19 as a global evolving pandemic highly dynamic. And we’re doing market research and evaluations across the various territories. Our Phase 2/3 study was global and we are approaching markets and regulators on a global basis. We do expect the market for COVID-19 worldwide to continue to be highly requiring new therapies. And as we see the emerging expected revenues of products that have been used and received emergency uses or approvals in this market, we see these very, very high and growing and we anticipate that to continue.
Dror Ben-Asher
Might add, Boobalan and thank you for the question. That if we look at the data from the last couple of weeks, we’re seeing very high numbers and rapidly increasing actually in Germany, in France, in the UK, many other countries. So, this is not going away unfortunately. And with BA.2 and future variants, this is likely to remain a very significant medical need and the resulting commercial market.
Boobalan Pachaiyappan
Thanks for the color. With respect to RHB-107 for COVID obviously. So the Phase 2 data is pretty intriguing. So, what are your preliminary thoughts regarding the Phase 3 study design? And will you consider including an active comparator drug in your future Phase 3?
Gilead Raday
Thank you. Yes, we are still in the process of completing the analysis of Part A, which as you mentioned and we disclosed, provided highly promising results despite being a small study in terms of the efficacy that is obtained. We are planning next steps and evaluating the next steps with FDA. We will approach FDA, present the full data and agree with them on next steps.
We see the next steps to continue studying the product in a large study in non-hospitalized patients with mild-to-moderate symptoms. And we expect to be able to replicate the very promising results. And given the very attractive profile of upamostat we think this could be a very important tool in treating the mild-to-moderate patients with COVID-19.
Boobalan Pachaiyappan
As an add-on on the same topic. Are you open to partner – partnering for the Phase 3 trial or future Phase 3 trial? Are you planning to go solo?
Dror Ben-Asher
Yes, we are having discussions. The strong results that were achieved in the study attracted a lot of attention. And this is not only from potential pharma partners, this is also government and other grants. So, when it comes to a large Phase 3, which we are confident about, we are confident it will be funded by external sources, be it industry or other.
Boobalan Pachaiyappan
Switching gears a little bit. Can you help frame the expectations for your upcoming cholangiocarcinoma study readout which is expected in second quarter and what kind of efficacy signals would generate investor confidence in this program?
Gilead Raday
Thank you. We have already disclosed that we have observed a signal of activity with patients which are very advanced after two lines of failing therapy in cholangiocarcinoma with nothing available to them. And this is a very promising signal of activity. We will complete analysis over the coming months and present the data and based on that, we will consider next steps – possibly refining the patient population targets using biomarkers is a very possible path. But again, overall, the clinicians who are very familiar with these dire condition of patients are optimistic that the signal is an important one for continuing developments of the program.
Boobalan Pachaiyappan
Right. One final from me if I may. How do you expect the R&D cost evolve for the remaining – for the year 2022?
Micha Ben Chorin
So as can be seen in our press release from today, we are targeting a cost reduction program, in which, we will enhance contribution and profitability to the maximum extent possible. So, we are expecting relatively a low investment in research and development during this year 2022.
Boobalan Pachaiyappan
All right. Thanks so much for taking my questions.
Operator
Thank you. I will now hand the call back to you.
Dror Ben-Asher
Thank you, Sharon and thanks everybody for joining the call. Please reach out to us if you have any additional questions. Keep safe and have a pleasant day.
Operator
Thank you. That does conclude today’s conference call. Thank you for participating. You may all disconnect.
Double digits in the
foreseeable future!
You mean there's still hope for this baby??? My fingers are still crossed!!!
Scrapiron, finally some Joy and contentment!
RedHill GAAP EPS of -$0.21 beats by $0.78, revenue of $85.76M misses by $2.14M
Mar. 17, 2022 8:08 AM ETRedHill Biopharma Ltd. (RDHL)
By: Niloofer Shaikh, SA News Editor
RedHill press release (NASDAQ:RDHL): FY GAAP EPS of -$0.21 beats by $0.78.
Revenue of $85.76M (+33.3% Y/Y) misses by $2.14M.
Micha Ben Chorin, Chief Financial Officer at RedHill, added: "We have realigned focus within our 120-person strong customer-facing sales team in the U.S., providing even greater sales emphasis. In addition, a substantial decrease in our quarterly operational expenses achieved through a tight but agile cost-containment plan that allows for rapid re-adjustments based on compelling business need, are now starting to be realized following implementation in Q4/21 and we believe will continue to bear fruit throughout 2022. These activities are key in our ongoing ability to deliver record revenues, which amounted to $85.8 million for 2021, while keeping gross margins highly competitive, with commercial operations profitability expected in 2022. We are committed to continued substantial cost reduction in 2022."
RedHill Biopharma Reports Operational Highlights and Fourth Quarter & Full Year 2021 Financial Results
https://finance.yahoo.com/news/redhill-biopharma-reports-operational-highlights-115900129.html
- Record annual and quarterly revenues of $85.8 and $22.1 million respectively - 2021 revenues up 33.2% vs. 2020, gross profit up 32.4% vs. 2020[1]
- Cash balance[2] of $54.2 million as of December 31, 2021
- Overall contribution of commercial operations to the company was positive for the first time in Q4 and commercial contribution is expected to continue to grow in 2022, with commercial operations profitability expected in 2022[3] supported by strengthened salesforce and disciplined cost-control measures
- Talicia now the most prescribed branded H. pylori therapy in the U.S. achieving record quarterly prescriptions in Q4, up 25.5% vs. Q3; Movantik up 2.4% vs. Q3 - leads the PAMORA class with 73% market share in a growing market
- Positive late-stage clinical data from studies with two leading novel, oral and variant-agnostic COVID-19 therapeutics opaganib and RHB-107; Multiple regulatory data and other submissions in process
- Two territorial out-licensing deals in new territories with upfront payments for opaganib and Talicia executed since the start of 2022. Discussions with additional potential partners ongoing
- Management to host webcast today, at 08:30 a.m. EDT
TEL AVIV, Israel and RALEIGH, N.C., March 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its operational highlights and financial results for the fourth quarter and full year ended December 31, 2021.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "In 2021, RedHill's team delivered record revenues against a pandemic backdrop, overall contribution of commercial operations to the company was positive for the first time in Q4/21 and positive late-stage clinical data for two novel oral COVID-19 drugs. A very strong fourth quarter for both Talicia® and Movantik®, coupled with disciplined cost-control measures across the business and intensive out-licensing and in-licensing activities, sets us up for continued organic and non-organic growth in 2022 and beyond."
Mr. Ben-Asher added: "Our R&D team's drive in remaining at the forefront of the global search for much needed novel oral COVID-19 therapies has been outstanding. The challenge of developing any drug is not to be underestimated and RedHill's R&D team has delivered exciting efficacy data with both opaganib and RHB-107, our variant-agnostic investigational drug candidates for the treatment of hospitalized and non-hospitalized COVID-19 respectively - a striking achievement."
Micha Ben Chorin, Chief Financial Officer at RedHill, added: "We have realigned focus within our 120-person strong customer-facing sales team in the U.S., providing even greater sales emphasis. In addition, a substantial decrease in our quarterly operational expenses achieved through a tight but agile cost-containment plan that allows for rapid re-adjustments based on compelling business need, are now starting to be realized following implementation in Q4/21 and we believe will continue to bear fruit throughout 2022. These activities are key in our ongoing ability to deliver record revenues, which amounted to $85.8 million for 2021, while keeping gross margins highly competitive, with commercial operations profitability expected in 2022. We are committed to continued substantial cost reduction in 2022."
Financial results for the quarter ended December 31, 2021 (Unaudited)[4]
Net Revenues for the fourth quarter of 2021 were $22.1 million, as compared to $21.6 million in the third quarter of 2021.
Cost of Revenues for the fourth quarter of 2021 were $19.3 million, as compared to $9.2 million in the third quarter of 2021. The increase was attributed to recognition of approximately $9 million impairment related to the intangible asset of Aemcolo® for travelers' diarrhea.
Gross Profit for the fourth quarter of 2021 was $2.7 million, as compared to $12.4 million in the third quarter of 2021. The decrease was attributed to the impairment recognized, as detailed above.
Research and Development Expenses for the fourth quarter of 2021 were $5.9 million, similar to the $5.8 million in the third quarter of 2021.
Selling, Marketing and General and Administrative Expenses for the fourth quarter of 2021 were $17.6 million, as compared to $24.0 million in the third quarter of 2021. The decrease was a result of the cost-containment plan implemented.
Operating Loss for the fourth quarter of 2021 were $20.7 million, as compared to $17.4 million in the third quarter of 2021. The increase is attributed to the impairment recognized, as detailed above, partly offset by the decrease in operating expenses, as detailed above.
Net Cash Used in Operating Activities for the fourth quarter of 2021 was $14.9 million, as compared to $19.0 million in the third quarter of 2021. The decrease was a direct result of the decrease in operating expenses, as detailed above.
Net Cash Provided by Financing Activities for the fourth quarter of 2021 was $17.6 million, mainly due to proceeds from equity offerings, as compared to Net Cash Used in Financing Activities of $1.0 million in the third quarter of 2021.
Financial results for the year ended December 31, 2021[4]
Net Revenues were $85.8 million for the year ended December 31, 2021, as compared to $64.4 million for the year ended December 31, 2020, a 33.2% increase in net revenues. The increase was attributable to the launch of Talicia and Movantik in March 2020 and April 2020, respectively, as well as growth in sales in comparable periods of both products.
Cost of Revenues were $49.4 million for the year ended December 31, 2021, as compared to $36.9 million for the year ended December 31, 2020. The increase was mostly attributable to recognition of approximately $9 million impairment related to the intangible asset of Aemcolo for travelers' diarrhea and in-line with the increase in net revenues from our commercial products.
Gross Profit was $36.4 million for the year ended December 31, 2021, as compared to $27.5 million for the year ended December 31, 2020. The increase was primarily due to the increase in net revenues, and partially offset by the recognized impairment of Aemcolo intangible asset.
Research and Development Expenses were $29.5 million for the year ended December 31, 2021, as compared to $16.5 million for the year ended December 31, 2020. The increase was mainly attributable to the advancement of our COVID-19 programs with opaganib and RHB-107.
Selling, Marketing and General and Administrative Expenses were $88.0 million for the year ended December 31, 2021, as compared to $74.7 million for the year ended December 31, 2020. The increase was mainly attributable to the expansion of commercialization activities related to Talicia and Movantik and to expenses related to share-based compensation.
Operating Loss was $81.1 million for the year ended December 31, 2021, as compared to $63.7 million for the year ended December 31, 2020. The increase was mainly attributable to the intensified activities in both commercial operations and R&D.
Net Cash Used in Operating Activities was $65.0 million for the year ended December 31, 2021, as compared to $48.6 million for the year ended December 31, 2020. The increase was mainly attributable to the increase in operating loss, as described above.
Net Cash Provided by Financing Activities was $73.5 million for the year ended December 31, 2021, comprised primarily of proceeds from equity offerings. Net Cash Provided by Financing Activities for the year ended December 31, 2020, was $84.4 million, comprised primarily of debt and equity-based financing, partially offset by $16 million classified as restricted cash.
Liquidity and Capital Resources
Cash Balance[2] as of December 31, 2021, was $54.2 million, as compared to $51.5 million as of September 30, 2021, and approximately $46 million as of December 31, 2020[5].
Strategic investment in RedHill by South Korea's Kukbo Co. ("Kukbo") - $5 million received and an additional $5 million investment expected per the agreement.
Opaganib[6] for COVID-19 licensed by Kukbo for South Korea for $1.5 million in upfront payment and additional payment up to $5.6 million in milestone payments and royalties on net sales.
Talicia for H. pylori licensed by Gaelan Medical for the United Arab Emirates, with $2 million upfront to be received plus milestones and royalties on net sales.
Discussions are ongoing with additional potential partners for Talicia in other territories.
Commercial Highlights
Movantik® (naloxegol)[7]
Movantik is the market leader in the PAMORA class holding 73% market share. The Company's drive and commitment to further growing Movantik and the PAMORA class, which has increased over the past 12 months, is delivering. In Q4/2021 Movantik had its best performance since RedHill's launch, growing new prescriptions by 2.4% compared to the previous quarter.
Nearly 92% of insurance plans provide access for Movantik – best-in-class coverage – and in December 2021, the Company announced that Movantik® had been approved for inclusion as preferred and unrestricted brand on a major National Medicare Part D formulary serving more than 10 million Americans as of January 1, 2022. 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.
In 2021 the Company also successfully brought to a close all presently pending Movantik patent litigation brought pursuant to the 'Drug Price Competition and Patent Term Restoration Act' (the Hatch-Waxman Act). The earliest licensed entry date of any generic naloxegol in the U.S. is October 1, 2030.
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[8]
Talicia is now the most prescribed branded H. pylori therapy in the U.S. and achieved another record quarter, delivering a 25.5% increase in prescriptions compared to the previous quarter, reflecting 78.4% growth of Talicia as compared to Q4/2020.
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 will receive 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. Gaelan Medical received 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.
In October, Medi-Cal, California's Medicaid Health Care program covering two million beneficiaries, added Talicia to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required. This coverage expanded to 14 million beneficiaries on January 1, 2022. As of December 2021, total Talicia coverage stood at greater than 197 million American lives, equating to 8 out of ten lives.
Also in October 2021, the Company announced the grant of a new U.S. Patent covering Talicia. This patent reinforces the protection for Talicia through 2034, and the Company has listed this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
Aemcolo® (rifamycin)[9]
The Company has maintained promotion of Aemcolo in the fourth quarter of 2021 in anticipation of renewed post-COVID-19 travel opportunities for Americans. In December 2021, the exclusive license agreement between the Company and Cosmo was amended to allow for provision for either party to terminate the agreement upon 90 days' notice at any time.
R&D Highlights
COVID-19 Program: Opaganib (ABC294640)
The Company previously announced top-line results from the oral opaganib global 463-patient Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840).
Since the initial results were announced, extensive review of all the data has shown compelling and consistent efficacy in large and important sub-group analyses and, earlier this year, the Company announced results from several recently completed prespecified analyses from the study showing that opaganib significantly reduced mortality when given to patients who received remdesivir and corticosteroids, delivered a significant benefit in time to recovery and improved the median time to viral RNA clearance:
A prespecified mortality analysis, undertaken for all patients from the Phase 2/3 study who were receiving remdesivir and corticosteroids at baseline, demonstrated a significant 70.2% mortality benefit for opaganib-treated patients, with a mortality rate of 6.98% (n=3/43) for the opaganib arm + SoC versus 23.4% (n=11/47) for placebo + SoC by Day 42 (p-value=0.034).
A second prespecified analysis showed that opaganib delivered a significant 34% benefit in time to recovery, defined as achieving a score of 1 or less on the WHO Ordinal Scale by Day 14, with 37.4% of opaganib-treated patients (n=86/230) reaching this event versus 27.9% of patients (n=65/233) treated with placebo + SoC (p-value=0.013, Hazard Ratio 1.49).
A third prespecified analysis, of all oral opaganib's Phase 2/3 study patients with positive PCR at screening, demonstrated that opaganib improved the median time to viral RNA clearance by at least 4 days. Treatment with opaganib resulted in viral RNA clearance in a median of 10 days while the median for clearance in the placebo arm was not reached by the end of 14-days treatment for placebo (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463)
In December 2021, the Company also announced that because opaganib's proposed mechanism of action is not impacted by spike protein mutations, opaganib is expected to be unaffected by mutations associated with Omicron and other known variants of concern.
Regulatory discussions are in progress, with opaganib data submissions in the U.S., Europe, UK and additional countries. Discussions remain ongoing with initial guidance requiring confirmatory data on potential path to approval received from the EU's EMA, the U.S. FDA, UK's MHRA and others. Data and other regulatory submissions are in process in multiple other countries. The Company continues its discussions with U.S. and other government agencies, non-governmental organizations and potential partners around potential funding to support the ongoing development of opaganib.
In March 2022, the Company announced that it has entered into an exclusive license agreement with Kukbo Co. Ltd., a South Korean corporation, which will receive the exclusive rights to commercialize opaganib for the treatment of COVID-19 in South Korea. Under the terms of the agreement, which adds to the previously announced strategic investment by Kukbo of up to $10 million, RedHill will in addition 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.
COVID-19 Program: RHB-107 (upamostat)[10]
RedHill continues to advance the Phase 2/3 study of novel, once-daily, orally-administered, antiviral drug candidate, 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. In March 2022, the Company announced positive top-line results from the Phase 2 part of the Phase 2/3 study, predominantly conducted in the U.S. (60/61 patients) as well as South Africa.
Although not powered for efficacy assessment, the study showed highly promising efficacy results delivering a 100% reduction in hospitalization due to COVID-19, with zero patients on the RHB-107 arm hospitalized with COVID-19 (0/41) compared to 15% on the placebo-controlled arm requiring hospitalization (3/20) (nominal p-value=0.0317). Furthermore, the study showed an 87.8% reduction in reported new severe COVID-19 symptoms, with only one patient on RHB-107 (2.4%, 1/41) compared to 20% (4/20) of patients on the placebo-controlled arm experiencing new COVID-19 related severe symptoms (nominal p-value=0.036).
The study met its primary outcome measure, demonstrating a favorable safety and tolerability profile of RHB-107. Study arms were well-balanced with respect to baseline disease severity, risk factors and vaccination status. Patients were also tested for the specific viral strain (last patient randomized November 12, 2021), with the most common variant being Delta, found in 62.5% of the patients that had next generation sequencing (NGS).
The Phase 2 part of the study was designed to evaluate safety for dose selection and to provide preliminary assessment of parameters to be used for efficacy evaluation in Part B. A total of 61 patients were enrolled in Part A and randomized on a 1:1:1 basis to receive one of two dose levels of RHB-107 or a placebo control.
Discussions with regulators to discuss next steps are expected during Q2/22.
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease[11]
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). Expansion of sites and the waning of COVID-19 is expected to increase the pace of enrolment.
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.
Conference Call and Webcast Information:
The Company will host a webcast today, Thursday, March 17, 2022, at 8:30 a.m. EDT, during which it will present key highlights for the fourth quarter and full year of 2021.
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.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167; and Israel: +972-3-530-8845; the access code for the call is: 2368401.
Midas,
Thanks for the good news! My fingers are still crossed. :)
RedHill and Kukbo Enter Oral Opaganib License for COVID-19 in South Korea
https://finance.yahoo.com/news/redhill-kukbo-enter-oral-opaganib-130000346.html
RedHill to receive $1.5 million upfront and is eligible for up to $5.6 million in milestone payments in addition to royalties on net sales from Kukbo
Opaganib's Phase 2/3 clinical data shows improved viral RNA clearance, reduced mortality on top of remdesivir & corticosteroids and faster time to recovery for moderate to severe hospitalized COVID-19 patients treated with opaganib; potent in vitro inhibition of multiple variants also demonstrated
TEL-AVIV, Israel, and RALEIGH, N.C., March 15, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that it has entered into an exclusive license agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for oral opaganib[1] for the treatment of COVID-19, in South Korea.
Under the terms of the license agreement, which follows the previously announced strategic investment by Kukbo, RedHill will 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.
Dror Ben-Asher, RedHill's CEO, said: "South Korea is currently experiencing a spike in COVID-19 cases with the Korea Disease Control & Prevention Agency reporting almost 4 million new cases already registered in the first half of March alone. Together with our partner, Kukbo, we are working hard to bring opaganib to Korean patients in need of new COVID-19 therapeutic options."
"Every day this month we are seeing an average of almost 2000 people hospitalized due to COVID-19 in South Korea and we desperately need medications that can effectively treat these patients," said Hyun Ha, Kukbo's CEO. "With the data supporting opaganib for COVID-19, and the expanded partnership with RedHill, Kukbo is determined to work with local regulators with the aim of bringing opaganib to South Korean patients, as soon as possible."
The partnership with Kukbo also includes a right of first offer for RedHill's late-stage clinical assets, opaganib, RHB-107 (upamostat)[2] and Talicia®, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and/or Malaysia. The right of first offer has been extended as part of the new license agreement until the end of October 2022.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
In prespecified analyses of Phase 2/3 clinical data, oral opaganib has demonstrated improved viral RNA clearance, significant mortality reduction on top of remdesivir and corticosteroids and faster time to recovery. Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[3].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
Finally some real good news!
Some time ago Amatuer17 has (rightly)
said there was a curse upon RDHL.
It certainly seems so!
Still holding tho.
Yes! It would be nice if something happened. All kidding aside...the company does seem to be very serious. I believe they do have core value...they do try hard. It just seems to always be bad timing, poor planning, etc., etc. Everything seems to work against them!
LOL, thanks Scrapiron. Truth is i wasn't
planning to tune into the webcast. I
agree it would be a total waste of time.
My hope is for some country, e.g Columbia
or Korea endorsing Opa for EUA. Only
this could be a game changer for RDHL.
Untill then: Zzzzzzz
Redhill Webcast:
"Everything is wonderful, we are excited about upcoming events, please invest more money!"
I just saved you the time of sitting through an hour-long webcast.
RedHill Biopharma to Host Fourth Quarter and Full Year 2021 Financial Results and Operational Highlights Webcast on March 17, 2022
https://finance.yahoo.com/news/redhill-biopharma-host-fourth-quarter-120000245.html
TEL AVIV, Israel and RALEIGH, NC, March 10, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its fourth quarter and full year 2021 financial results and operational highlights on Thursday, March 17, 2022.
The Company will host a conference call and webcast on Thursday, March 17, 2022, at 8:30 a.m. EDT, during which it will present key highlights for the fourth quarter and full year of 2021.
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.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167; and Israel: +972-3-530-8845; the access code for the call is: 2368401.
Thank you! Very interesting!
COVID SCIENCE-Redhill antiviral shows promise in safety study; J&J shot less effective preventing hospitalization
https://finance.yahoo.com/news/covid-science-redhill-antiviral-shows-211825764.html
Wed, March 2, 2022, 11:18 PM
In this article:
RDHL
+2.03%
PFE
+4.26%
By Nancy Lapid
March 2 (Reuters) - The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.
Redhill drug blocks proteins that help the coronavirus
An experimental oral drug being developed by Redhill Biopharma Inc interrupts a process that helps the coronavirus infect cells and might keep COVID-19 patients from becoming seriously ill, the company said.
The virus co-opts proteins in the human body called serine proteases and uses them to prepare its spike to break into cells and infect them. The drug, RHB-107, blocks the proteins' activity. The new findings come from a small trial to confirm the safety of the drug in recently infected, symptomatic but non-hospitalized COVID-19 patients. While a larger study is needed to demonstrate efficacy, Redhill in a statement https://www.prnewswire.com/il/news-releases/redhill-announces-positive-phase-2-study-results-with-oral-rhb-107-in-non-hospitalized-covid-19-301492827.html said among the 61 adults in the trial, no one taking once-daily RHB-107 (upamostat) needed to be hospitalized, compared to 15% of those in a placebo group. Rates of new-onset severe symptoms were 2.4% with RHB-107 and 20% with the placebo. Because RHB-107 acts against human proteins that are involved in preparing the virus spike for cell entry, rather than acting against the spike itself, the researchers said they expect it could be effective against new variants despite mutations in the spike.
A larger randomized trial https://clinicaltrials.gov/ct2/show/NCT04723537 is underway but results are not yet available. Pfizer's Paxlovid pill, which has emergency use authorization for patients with early COVID-19, is also a protease inhibitor.
J&J shot less effective against COVID hospitalization
The risk of hospitalization after vaccination with Johnson & Johnson's COVID-19 vaccine was about five times higher than for those who received the Pfizer and BioNTech shot, a large French study found.
The study included nearly 7 million recipients of the two-dose mRNA vaccine from Pfizer/BioNTech and an equal number of similar people who received the one-shot vector-based vaccine from J&J. The average age was about 66, and about half were women. By the time half the participants had been fully vaccinated for at least six weeks, there had been 129 hospitalizations among J&J vaccine recipients versus 23 among the Pfizer/BioNTech group, the researchers reported on Wednesday in JAMA Network Open https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2789572.
Based on their data, they estimated the effectiveness of the vaccines at preventing hospitalization at 92% for Pfizer's shots versus 59% for the J&J vaccine. "These results strengthen the evidence" in favor of giving an mRNA booster shot to people who initially received the J&J vaccine, the authors conclude.
Experimental vaccine uses spike without sugar-coating
The SARS-CoV-2 virus in lung cells coats itself in sugars produced by the infected person's body, which help hide parts of the virus that antibodies could target. A vaccine being tested by researchers aims to foil that trick by showing the immune system those virus parts with the sugars stripped away.
By using enzymes in a modified production process, researchers obtained a coronavirus spike protein without the sugar shields, said Chi-Huey Wong of The Scripps Research Institute in La Jolla, California. Unlike current vaccines, a vaccine that shows the entire uncoated spike to the body would likely be more effective, stimulating broader responses against variants, because the sugars disguise the parts of the spike that the variants all have in common, the researchers said. In mice, the experimental vaccine that presented the immune system with an uncoated spike "elicited stronger immune responses and better protection against variants of concern" compared to vaccines that target the original spike, according to a report published on Tuesday in Science Translational Medicine https://www.science.org/doi/full/10.1126/scitranslmed.abm0899.
Removing the glycan shields to better expose the unmutated parts of the spike "has the potential to be an effective and simple approach for developing a broadly protective SARS-CoV-2 vaccine," the researchers conclude.
Click for a Reuters graphic https://tmsnrt.rs/3c7R3Bl on vaccines in development.
(Reporting by Nancy Lapid; Editing by Bill Berkrot)
Simply Wall St too took the words right out of your mouth!
God’s last miracle was the ‘69 Mets.
That was George Burns in Oh God
RedHill and PSTI will go to double digits - no miracle. Just smart scientists in the right place at the right time
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Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
(Posted 12/22/2020)
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[2] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=17299
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