Naloxegol Oxalate

Presentations showcase diversity and momentum of Pfizer’s growing portfolio of vaccines and anti-infectives NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2023 held in Boston from October 11-15, 2023. Data from 45 abstracts will highlight the advances Pfizer is making in helping prevent and treat certain infectious diseases, particularly respiratory illnesses. This will include research featured in the IDWeek press program assessing the potential public health impact of ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine for maternal immunization to protect infants against RSV illness. “The data at this year’s IDWeek highlight Pfizer’s commitment to transforming respiratory health, an area where we are proud to have delivered several innovative vaccine and treatment options over the last three years. We also continue to actively investigate infectious diseases more broadly, with a diverse pipeline of innovative vaccine and anti-infective treatment candidates,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “With our unique scientific capabilities and vaccine technology platforms, we are unwavering in the fight against the world’s most pressing disease challenges. We are excited to present our latest clinical results that support our growing infectious disease portfolio for the purpose of improving global health outcomes.” "The burden of respiratory illnesses on global public health is significant. It is particularly relevant as we enter the winter respiratory season in the Northern Hemisphere and once again face the threat of a possible tripledemic with influenza, RSV and COVID-19 co-circulating,” said Luis Jodar, Ph. D., Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. “At IDWeek, we are pleased to share real-world data that will help educate healthcare professionals about the role Pfizer’s vaccines and treatments can play in helping mitigate the impact of certain respiratory infections during this critical period.” Pfizer's participation at IDWeek 2023 comprises breakthrough research from across the company’s robust infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, multidrug-resistant gram-negative bacterial infections and more. Eight abstracts have been selected for oral presentation, including data on the successful coadministration of ABRYSVO with an influenza vaccine in older adults and results from the Phase 3 REVISIT study of Pfizer’s investigational antibiotic combination aztreonam-avibactam (ATM-AVI) candidate. Data highlighting the real-world effectiveness of Pfizer’s FDA-approved COVID-19 oral treatment for adults, PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets), will also be featured at the meeting. A complete list of Pfizer-sponsored accepted abstracts is available here. Details for Pfizer-sponsored oral presentations are below: Title/ Abstract Number Presenting Name/Type Date/ Time EDT Location IDWEEK PRESS PROGRAM 1942 - Potential Public Health Impact of Bivalent Respiratory Syncytial Virus Prefusion F (RSVpreF) Maternal Vaccine for Prevention of RSV Among US Infants Amy W. Law, PharmD Oct 13 2:15 - 2:30 PM US ET 104 ABC ORAL PRESENTATIONS 1019 - Respiratory Syncytial Virus (RSV) Diagnoses in Hospitalized Patients Increases when Additional Specimen Types are Added to Nasopharyngeal Swab: Results from the RSV in Adults Multispecimen Study Elizabeth Begier, MD, MPH Oct 12 3:15 - 3:33 PM US ET 104 ABC 1941 - Coadministration of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine with Influenza Vaccine in Older Adults James Baber, MBChB, MPH Oct 13 2:00 - 2:15 PM US ET 104 ABC 1944 - Tolerability and Safety of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Infants and Older Children in Global Studies Kathleen McElwee, MD, MPH Oct 13 2:45 - 3:00 PM US ET 104 ABC 1948 - Rise of Candida auris Infections Worldwide and Trends on the Activity of Fosmanogepix and Comparator Agents Against C. auris Causing Invasive Infections Cecilia G. Carvalhaes, MD, PhD Oct 13 2:30 - 2:45 PM US ET 102 AB 1949 – Activity of Aztreonam-Avibactam Against Enterobacterales Resistant to Recently Approved Beta-Lactamase Inhibitor Combinations Collected Worldwide (ex-US: 2020-2022) Helio S. Sader, MD, PhD, FIDSA Oct 13 2:45 - 3:00 PM US ET 102 AB 2890 - Pharmacokinetics, Safety, and Efficacy of Ceftazidime-Avibactam in Neonates and Young Infants with Bacterial Infections: Results from a Phase 2a, 2-part, Open-label, Non-randomized, Multicenter Trial Richard D England, MD Oct 14 2:05 - 2:15 PM US ET 254 AB 2893 - Efficacy and Safety of Aztreonam-Avibactam for the Treatment of Serious Infections Due to Gram-Negative Bacteria, Including Metallo-β-Lactamase-Producing Pathogens: Phase 3 REVISIT Study Yehuda Carmeli, MD MPH Oct 14 2:35 - 2:45 PM US ET 254 AB INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR ABRYSVO U.S. INDICATIONS ABRYSVOTM is a vaccine indicated for: the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age IMPORTANT SAFETY INFORMATION ABRYSVO should not be given to anyone with a history of severe allergic reaction (eg, anaphylaxis) to any of its components For pregnant individuals: to avoid the potential risks of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO Vaccination with ABRYSVO may not protect all people In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, nausea In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo View the full Prescribing Information. INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION FOR PAXLOVID U.S. Indication PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Limitations of Use PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19. U.S. FDA Emergency Use Authorization Statement The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of PAXLOVID for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with mild to moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. IMPORTANT SAFETY INFORMATION WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID PAXLOVID includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, or fatal events Prior to prescribing PAXLOVID: 1) Review all medications taken by the patient to assess potential drug-drug interactions with a strong CYP3A inhibitor like PAXLOVID and 2) Determine if concomitant medications require a dose adjustment, interruption, and/or additional monitoring Consider the benefit of PAXLOVID treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care. PAXLOVID is contraindicated with drugs that are primarily metabolized by CYP3A and for which elevated concentrations are associated with serious and/or life-threatening reactions and drugs that are strong CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. There are certain other drugs for which concomitant use with PAXLOVID should be avoided and/or dose adjustment, interruption, or therapeutic monitoring is recommended. Drugs listed here are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor like PAXLOVID. Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions: Alpha 1-adrenoreceptor antagonist: alfuzosin Antianginal: ranolazine Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine Anti-gout: colchicine (in patients with renal and/or hepatic impairment) Antipsychotics: lurasidone, pimozide Benign prostatic hyperplasia agents: silodosin Cardiovascular agents: eplerenone, ivabradine Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine HMG-CoA reductase inhibitors: lovastatin, simvastatin (these drugs can be temporarily discontinued to allow PAXLOVID use) Immunosuppressants: voclosporin Microsomal triglyceride transfer protein inhibitor: lomitapide Migraine medications: eletriptan, ubrogepant Mineralocorticoid receptor antagonists: finerenone Opioid antagonists: naloxegol PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension Sedative/hypnotics: triazolam, oral midazolam Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin Vasopressin receptor antagonists: tolvaptan Drugs that are strong CYP3A inducers: PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer: Anticancer drugs: apalutamide Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin Antimycobacterials: rifampin, rifapentine Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor Herbal Products: St. John’s Wort (hypericum perforatum) Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, which contains ritonavir, a strong CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Medications that induce CYP3A may decrease concentrations of PAXLOVID. These interactions may lead to: Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications Loss of therapeutic effect of PAXLOVID and possible development of viral resistance Severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with PAXLOVID. The most commonly reported concomitant medications resulting in serious adverse reactions were calcineurin inhibitors (eg, tacrolimus, cyclosporine), followed by calcium channel blockers. Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Because nirmatrelvir is coadministered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection. The most common adverse reactions in the PAXLOVID group (≥1%) that occurred at a greater frequency than in the placebo group were dysgeusia (5% and <1%, respectively) and diarrhea (3% and 2%, respectively). The following adverse reactions have been identified during use of PAXLOVID under Emergency Use Authorization: Immune System Disorders: Anaphylaxis, hypersensitivity reactions Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome Nervous System Disorders: Headache Vascular Disorders: Hypertension Gastrointestinal Disorders: Abdominal pain, nausea, vomiting General Disorders and Administration Site Conditions: Malaise PAXLOVID is a strong inhibitor of CYP3A, and an inhibitor of CYP2D6, P-gp, and OATP1B1. Coadministration of PAXLOVID with drugs that are primarily metabolized by CYP3A and CYP2D6 or are transported by P-gp or OATP1B1 may result in increased plasma concentrations of such drugs and increase the risk of adverse events. Coadministration with other CYP3A substrates may require a dose adjustment or additional monitoring. Pregnancy: Available data on the use of nirmatrelvir during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with ritonavir are insufficient to identify a drug-associated risk of miscarriage. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. Lactation: There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. Limited published data report that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. Pediatrics: The optimal dose of PAXLOVID has not been established in pediatric patients. Systemic exposure of nirmatrelvir increases in renally impaired patients with increase in the severity of renal impairment. No dosage adjustment is recommended in patients with mild renal impairment. Reduce the dose of PAXLOVID in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min). PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min) or in patients with end-stage renal disease (eGFR <15 mL/min). PAXLOVID is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Please see Full Prescribing Information, including BOXED WARNING and Patient Information Click for Fact Sheets: For Consumers: EUA Fact sheet for Patients, Parents, and Caregivers For Healthcare Professionals: EUA Fact Sheet for HCPs INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR PREVNAR 20 U.S. INDICATIONS PREVNAR 20® is a vaccine approved for: the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks and older. the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years. IMPORTANT SAFETY INFORMATION PREVNAR 20 should not be given to anyone who has had a severe allergic reaction to any component of PREVNAR 20 or to diphtheria–toxoid-containing vaccine. Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups. A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your doctor about the infant's medical status when deciding to get vaccinated with PREVNAR 20. In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite and injection site redness, injection site swelling, and fever. In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling and injection site redness, headache, and fever. Ask your doctor about the risks and benefits of PREVNAR 20. Only a doctor can decide if PREVNAR 20 is right for your child. View the full Prescribing Information. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Disclosure Notice The information contained in this release is as of October 5, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including ABRYSVO (RSVpreF), Pfizer’s aztreonam-avibactam (ATM-AVI) candidate and PAXLOVID, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 or pre-clinical data for ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates, including the data discussed in this release) in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data; risks associated with interim data, including the risk that final results from the Phase 3 trials for RSVpreF could differ from the interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; the ability to produce comparable clinical or other results for ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates, including efficacy, safety and tolerability pro to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of ABRYSVO (RSVpreF) and PAXLOVID to be effective against emerging virus variants; the risk that the use of ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications or submissions to request emergency use or conditional marketing authorizations for any potential indications for ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates may be filed in any jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates (including any requested amendments to the emergency use or conditional marketing authorizations) may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates, including the authorization or approval of products or therapies developed by other companies; the risk that demand for any of our products may be reduced, no longer exist or not meet expectations, which may lead to excess inventory on-hand and/or in the channel, inventory write-offs or reduced revenues; challenges related to and uncertainties regarding the timing of a transition to the commercial market for any of our products; uncertainties related to the public’s adherence to vaccines and boosters; risks related to our ability to achieve our revenue forecasts for any of Pfizer’s infectious disease products or product candidates; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test Pfizer’s infectious disease products or product candidates; challenges related to our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines or potential combination respiratory vaccines; whether and when additional supply or purchase agreements will be reached or existing agreements will be completed or renegotiated; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO (RSVpreF) or any of Pfizer’s other infectious disease products or product candidates and uncertainties regarding the commercial impact of any such recommendations; pricing and access challenges; challenges related to public confidence in, or awareness of ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and .

RHB-107 included in the U.S. Department of Defense-supported ACESO PROTECT multinational platform trial for early COVID-19 outpatient treatment; The 300-patient Phase 2 study received FDA clearance and is estimated to be completed by the end of 2024 Opaganib awarded a further $1.7 million in U.S. government medical countermeasure (MCM) development funding – additional to the multimillion dollar-valued National Institutes of Health's Radiation and Nuclear Countermeasures Program (RNCP) product development contract for gastrointestinal acute radiation syndrome (GI-ARS) Following the divestiture of Movantik and the ongoing commercial and financial streamlining, the Company is debt-free, with a significantly reduced cost-base H1/23 Talicia net revenues of $5.1 million; Cash balance of $16.3 million as of June 30, 2023[1] TEL AVIV, Israel and RALEIGH, N.C., Aug. 17, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today provided first half, 2023, financial results and operational highlights. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "RedHill has delivered significant achievements in the first half of 2023. We are now debt-free with a significantly reduced cost-base. Our two lead R&D candidates, RHB-107 and opaganib, are progressing their development in outpatient COVID-19 and Acute Radiation Syndrome, respectively, both supported extensively by U.S. government funding. Additionally, we are in active discussions with multiple parties regarding potential divestment of certain RedHill assets, in order to further strengthen our balance sheet and enhance our focus." Financial results for the six months ended June 30, 2023 (Unaudited)2 Net Revenues for the six months ended June 30, 2023, were $5.4 million, as compared to $31.5 million for the six months ended June 30, 2022. The decrease was primarily attributable to the divestiture of Movantik, resulting in the discontinuation of revenue recognition from this product starting from February 2, 2023. Talicia net revenues for the six months ended June 30, 2023, were $5.1 million, as compared to $4 million for the six months ended June 30, 2022, primarily due to an increase of 10% in units sold. Cost of Revenues for the six months ended June 30, 2023, was $2.4 million, as compared to $15.3 million for the six months ended June 30, 2022. This decrease was primarily attributable to the divestiture of Movantik. As a result of this divestiture, both the recognition of revenues and the associated cost of revenues for this product were discontinued starting from February 2, 2023. Additionally, the amortization of the intangible asset related to Movantik was also discontinued as of that date. Gross Profit for the six months ended June 30, 2023, was $3 million, as compared to $16.2 million for the six months ended June 30, 2022, in line with the decrease in Net Revenues and Cost of Revenues as explained above and primarily attributable to the divestiture of Movantik. Research and Development Expenses for the six months ended June 30, 2023, were $2.3 million, as compared to $4.5 million for the six months ended June 30, 2022. The decrease is attributable to completion of clinical trials related to COVID-19 and ongoing cost-reduction measures. Selling, Marketing and General and Administrative Expenses for the six months ended June 30, 2023, were $19 million, as compared to $37.4 million for the six months ended June 30, 2022. The difference was primarily attributable to the ongoing cost-reduction measures. Other Income for the six months ended June 30, 2023, was $43 million, as compared to no other income recognized for the six months ended June 30, 2022. The other income was comprised of (i) $35.5 million from the divestiture of Movantik, calculated as the difference between the fair value of the rights and the carrying amount of this asset; and (ii) $7.5 million from transitional services fees provided to the buyer of Movantik. Operating Income for the six months ended June 30, 2023, was $24.7 million, as compared to an operating loss of $25.8 million for the six months ended June 30, 2022, primarily attributable to the changes resulting from the divestiture of Movantik, as detailed above. Financial Income, net for the six months ended June 30, 2023, was $26.3 million, as compared to Financial Expenses, net of $6.5 million for the six months ended June 30, 2022. The income recognized in the six months ended June 30, 2023, was primarily attributable to gain resulting from the extinguishment of the HCR Collateral Management LLC ("HCR") debt in exchange for the transfer of rights to Movantik, calculated as the difference between the carrying amount of the financial liability and the fair value of the rights transferred. Net Income for the six months ended June 30, 2023, was $51 million, as compared to Net Loss of $32.2 million for the six months ended June 30, 2022, primarily attributable to the changes resulting from the sale of Movantik, as detailed above. Total Assets as of June 30, 2023, were $35 million, as compared to $158.9 million as of December 31, 2022. The decrease was primarily attributable to the divestiture of Movantik, resulting in the transfer of the rights to Movantik, as well as to a significant decrease in the Trade Receivables balance (attributed to the fact that the receivables as of December 31, 2022, were primarily associated with Movantik). Total Liabilities as of June 30, 2023, were $31.6 million, as compared to $207.3 million as of December 31, 2022. The decrease was primarily attributable to the extinguishment of HCR debt in exchange for the transfer of Movantik rights, assumption of certain liabilities by HCR, and payments made towards pre-closing liabilities related to Movantik. Remaining pre-closing liabilities related to Movantik as of June 30, 2023, are estimated at $14.9 million. Net Cash Used in Operating Activities for the six months ended June 30, 2023, was $17.8 million, as compared to $20.7 million for the six months ended June 30, 2022. The difference was primarily attributable to the ongoing cost reductions. In the six months ended June 30, 2023, the cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik. Net Cash Provided by Financing Activities for the six months ended June 30, 2023, was $4.8 million, comprised primarily from the net proceeds from the offering completed on April 3, 2023, and the decrease in restricted cash, partially offset by repayment of payables in respect of intangible asset purchase. Cash Balance as of June 30, 2023, was $16.3 million1. Business updates On July 31, 2023, the Company announced that RHB-107 (upamostat)3 had been accepted for inclusion in the 300-patient U.S. Department of Defense-supported Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) PROTECT multinational platform trial for early COVID-19 outpatient treatment to be conducted in the U.S., Thailand, Ivory Coast and South Africa. On July 21, 2023, the Company announced that opaganib4 had been awarded a further $1.7 million in U.S. government funding, via a Small Business Innovation Research (SBIR) grant to the Company's development partner, Apogee Biotechnology Corporation ("Apogee"). This SBIR grant will support research to further the development of opaganib as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). This grant is in addition and complementary to the multimillion dollar-valued NIH's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development, announced on February 28, 2023. On July 25, 2023, the Company closed a $3.8 million registered direct offering for the purchase and sale of 1,301,923 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing four hundred (400) ordinary shares, at a purchase price of $1.35 per ADS (or ADS equivalent). Pursuant to a warrant exercise and reload agreement, dated July 21, 2023, with a certain holder holding Series A warrants to purchase up to an aggregate of 1,500,000 ADSs and Series B warrants to purchase up to an aggregate of 1,500,000 ADSs previously issued in March 2023, such holder exercised its Series A warrants in full at a reduced exercised price of $1.35 per ADS, in exchange for new unregistered warrants to purchase up to an aggregate of 1,500,000 ADSs at an exercise price of $1.80 per ADS and an expiration date of April 3, 2028, and a reduction in the exercise price of the Series B warrants to $1.80 per ADS. The Company had also agreed to amend (i) certain existing warrants to purchase up to an aggregate of 330,106 ADSs at an exercise price of $4.75 per ADS and (ii) certain existing warrants to purchase up to an aggregate of 971,817 ADSs at an exercise price of $4.6305 per ADS, so that the amended warrants have a reduced exercise price of $1.80 per ADS effective upon the closing of the registered direct offering. On May 9, 2023, the Company received a written notification from the Nasdaq Stock Market LLC ("Nasdaq"), indicating that the Company is not in compliance with the minimum Market Value of Publicly Held Shares ("MVPHS") set forth in the Nasdaq Rules for continued Nasdaq listing. Nasdaq Listing Rule 5450(b)(3)(C) requires companies to maintain a minimum MVPHS of $15 million, and Listing Rule 5810(c)(3)(D) provides that a failure to meet the MVPHS requirement exists if the deficiency continues for a period of 30 consecutive business days. Pursuant to Nasdaq Listing Rule 5810(c)(3)(D), the Company has a compliance period of 180 calendar days (or until November 6, 2023) to regain compliance. If at any time during this compliance period the Company's MVPHS closes at US$15 million or more for a minimum of ten consecutive business days, Nasdaq will notify the Company that it has achieved compliance with the MVPHS requirement, and the MVPHS matter will be closed. In the event the Company does not regain compliance with Rule 5450(b)(3)(C) prior to the expiration of the compliance period, it will receive written notification that its securities are subject to delisting. Alternatively, the Company may consider applying to transfer its securities to the Nasdaq Capital Market. This notification does not impact the listing and trading of the Company's securities at this time. On April 3, 2023, the Company closed a $6 million registered direct offering for the purchase and sale of 1,500,000 of the ADSs (or ADS equivalents), Series A warrants to purchase up to an aggregate of 1,500,000 ADSs and Series B warrants to purchase up to an aggregate of 1,500,000 ADSs. The Series A warrants had an exercise price of $4.75 per ADS, which was subsequently reduced to $1.35 per ADS as discussed above, were exercisable immediately and had a term of five years following issuance, and the Series B warrants had an exercise price of $4.00 per ADS, which was subsequently reduced to $1.80 per ADS as discussed above, are exercisable immediately and have a term of nine months following issuance. 811,000 ADSs underlying pre-funded warrants purchased at the registered direct offering were exercised following the closing of the offering. The Company recognized $1.1 million as a financial expense in the second quarter of 2023 due to the difference between the fair value of the warrants arising from the registered direct offering to the transaction price. As of August 15, 2023, the Company had 5,854,528 ADSs outstanding. On February 6, 2023, the Company announced the extinguishment of all RedHill's debt obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement between RedHill's U.S. subsidiary, RedHill Biopharma Inc., and HCR, announced February 25, 2020, as amended, in exchange for the transfer of its rights in Movantik® (naloxegol) to Movantik Acquisition Co., an affiliate of HCR. HCR assumed substantially all post-closing liabilities, and RedHill retained substantially all pre-closing liabilities relating to Movantik. As part of the parties' arrangement, and to ensure continuous patient care, RedHill provides HCR with transition services for up to 12 months, paid for by HCR. HCR will retain security interests in certain RedHill assets until substantially all pre-closing liabilities relating to Movantik have been paid or other specific conditions are met. RedHill continues its litigation against Kukbo Co. Ltd. ("Kukbo") which was filed on September 2022 as a result of Kukbo's default in delivering to RedHill a total of $6.5 million under the Subscription Agreement, dated October 25, 2021, and the Exclusive License Agreement, dated March 14, 2022. Following a recent decision denying RedHill's motion to reargue while otherwise correcting the misapprehension that was the basis for the motion, the parties continue to proceed with discovery and RedHill plans to continue to rigorously pursue the Kukbo litigation. RedHill is actively pursuing, and in discussions with multiple parties, regarding strategic business development transactions, including potential divestment of certain RedHill assets. Commercial Highlights Talicia® (omeprazole magnesium, amoxicillin and rifabutin)5 H1/23 saw Talicia recording net revenues of $5.1 million, maintaining its place as the leading prescribed branded H. pylori therapy by U.S. gastroenterologists6. On August 1, 2023, the Company announced that its partner, Gaelan Medical LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), had received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia and that Gaelen had placed an initial Talicia order and were commencing commercialization activities. On May 9, 2023, the Company announced new Talicia PBPK modeling data, published in AP&T Journal7, showing that generically substituted regimens are non-bioequivalent to Talicia. Separately, new Talicia PBPK modeling data, presented at Digestive Diseases Week (DDW) 2023, supports bioequivalence between TID and Q8H dosing regimens for Helicobacter pylori (H. pylori) eradication therapy; TID dosing is thought to promote patient adherence without impacting efficacy. Total Talicia coverage stood at more than 202 million American lives as of June 30, 2023, with 7 out of 10 commercial lives covered8. Movantik® (naloxegol)9 Following the sale of Movantik to Movantik Acquisition Co., an affiliate of HCR, and to ensure continuous patient care, RedHill continues to and will provide HCR with transition services for up to 12 months, paid for by HCR. R&D Highlights Opaganib (ABC294640) – A novel broad-acting, host-directed oral small molecule capsule targeting radioprotection, COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications. Nuclear Medical Countermeasures (Acute Radiation Syndrome): On July 21, 2023, the Company announced that opaganib had been awarded a further $1.7 million in U.S. government funding, via a SBIR grant to the Company's development partner, Apogee. This SBIR grant will support research to further the development of opaganib as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). This grant is in addition and complementary to the multimillion dollar-valued RNCP product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development, announced on February 28, 2023. On February 28, 2023, the Company announced that the RNCP, of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has selected opaganib for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS). As part of this collaboration, contractors directed and supported by the RNCP will undertake studies, designed in collaboration with RedHill, to test opaganib in established ARS models. This announcement followed the February 15, 2023, announcement that the FDA provided guidance on the use of the Animal Rule for opaganib's developmental pathway for Acute Radiation Syndrome (ARS), utilizing pivotal animal model efficacy studies instead of human clinical trials. Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher. These announcements followed publication of data from eight U.S. government-funded in vivo studies, and additional experiments, indicating that opaganib was associated with10: - Protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy. - Improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival. Additional collaboration discussions with the U.S. and other governments are ongoing. Pandemic preparedness and oncology: Preclinical development of opaganib, in collaboration with the U.S. Army and NIAID, for various antiviral indications is ongoing. On May 1, 2023, the Company announced that the U.S. Patent and Trademark Office (USPTO) had granted a new patent for opaganib in respect to combination compositions for treatment of cancer, extending protection to October 2036. RHB-107 (upamostat) – A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications. Outpatient treatment of COVID-19: On July 31, 2023, the Company announced that RHB-107 (upamostat) had been accepted for inclusion in the U.S. Department of Defense-supported Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) PROTECT multinational platform trial for early COVID-19 outpatient treatment to be conducted in the U.S., Thailand, Ivory Coast and South Africa. The 300-patient Phase 2 study has received FDA clearance to start and is estimated to be completed by the end of 2024. On January 3, 2023, the Company announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, in the peer-reviewed International Journal of Infectious Diseases11. The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each treatment group, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19. Discussions are ongoing for external non-dilutive funding for additional late-stage COVID-19 clinical development. Pandemic preparedness / additional viral indications: RHB-107 is also the subject of several cooperative research projects with government and non-government bodies, evaluating RHB-107 against multiple viral targets, including influenza and Ebola (amongst others). RHB-102 (BEKINDA)12 – Oncology Support On May 1, 2023, the Company announced that the European Patent Office granted RHB-102 (BEKINDA), a 24-hr bimodal release, once-daily oral tablet formulation of ondansetron, a patent covering antiemetic extended-release solid dosage forms for the prevention of nausea and vomiting (CINV/RINV). The patent provides the potential for UK and EU protection of RHB-102 to March 2034. On February 16, 2023, the Company announced that it held a positive pre-Marketing Authorisation Application meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) with regard to seeking marketing approval for RHB-102 (BEKINDA) for oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV). RHB-20413 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease On May 22, 2023, the Company announced the termination of RHB-204's U.S. Phase 3 study for non-tuberculosis mycobacteria (NTM) disease due to a very low accrual rate. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo®, for the treatment of travelers' diarrhea in adults14. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first -in -class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. Government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. More information about the Company is available at: / twitter.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements, including, but not limited to, statements regarding the intended use of net proceeds therefrom, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding anticipated the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, market and other conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107, the risk that HB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 28, 2023. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 adi@redhillbio.com Category: Financials 1 Including cash, cash equivalents, short-term bank deposits and restricted cash. 2 All financial highlights are approximate and are rounded to the nearest hundreds of thousands 3 RHB-107 is an investigational new drug, not available for commercial distribution. 4 Opaganib is an investigational new drug, not available for commercial distribution. 5 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . 6 IQVIA XPO Data on file 7 Howden et al. Physiologically based pharmacokinetic modelling to predict intragastric rifabutin concentrations in the treatment of Helicobacter pylori infection. Alimentary Pharmacology and Therapeutics, April 2023. 8 Managed Markets Insight & Technology, LLC 9 Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: . 10 Maines LW, Schrecengost RS, Zhuang Y, Keller SN, Smith RA, Green CL, Smith CD. Opaganib Protects against Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy. International Journal of Molecular Sciences. 2022; 23(21):13191. 11 Plasse et al. A randomized, placebo-controlled pilot study of upamostat, a host-directed serine protease inhibitor, for outpatient treatment of COVID-19. International Journal of Infectious Diseases, Vol 128, P148-156, March 2023. 12 RHB-102 is an investigational new drug, not available for commercial distribution. 13 RHB-204 is an investigational new drug, not available for commercial distribution. 14 Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: . Logo : SOURCE RedHill Biopharma Ltd.