Latest news with #Beyonttra
Yahoo
14-05-2025
- Business
- Yahoo
Bayer AG (BAYRY) Q1 2025 Earnings Call Highlights: Navigating Challenges and Capitalizing on ...
Revenue: Flat year-over-year, within the -3% to +1% corridor guidance for 2025. Core EPS: EUR2.49, on track to reach EUR4.50 to EUR5.00 at constant currencies. Free Cash Flow: Minus EUR1.5 billion, EUR1 billion improvement from last year. Crop Science Sales: Declined 3%, with regulatory impacts affecting higher margin sales. Pharmaceuticals Sales: Grew 4%, with Nubeqa and Kerendia increasing 80% year-over-year. Consumer Health Sales: Increased 2.5%, with 2% volume growth. EBITDA Before Special Items: EUR4.1 billion, 7% below prior-year quarter. Net Financial Debt: Increased by EUR1.7 billion to EUR34.3 billion since year-end 2024. Crop Science EBITDA Margin: 33.7%, 10% lower due to regulatory impacts and corn phasing. Pharmaceuticals EBITDA Margin: 29.5%, increased by 12% due to higher sales and efficiency gains. Consumer Health EBITDA Margin: 22.8%, slightly below prior year but within guidance range. Warning! GuruFocus has detected 3 Warning Sign with BAYRY. Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Bayer AG (BAYRY) reported a strong performance in its Pharmaceuticals division with a 4% growth, driven by the exceptional momentum of Nubeqa and Kerendia, which grew 80% year-over-year. The company achieved a 12% increase in EBITDA before special items in the Pharmaceuticals division, indicating effective cost management and efficiency gains. Consumer Health division saw a 2.5% growth, with a 2% increase in volume, positioning the division well to meet its annual guidance. Bayer AG (BAYRY) is on track to meet its full-year guidance for 2025, with core EPS expected to be between EUR4.50 to EUR5.00 at constant currencies. The company has made significant progress in its strategic priorities, including the launch of Beyonttra in the EU and preparations for the launch of elinzanetant in the second half of the year. Bayer AG (BAYRY) reported a 3% decline in sales for its Crop Science division, primarily due to regulatory impacts affecting higher margin sales. The company's free cash flow was negative at EUR1.5 billion, attributed to the seasonality of the Crop business, although it showed improvement from the previous year. Xarelto sales declined by 31% due to continued generic pressure in Europe and Japan, impacting the Pharmaceuticals division's top and bottom line. The Consumer Health division experienced soft conditions in key markets, with a slight decline in margins compared to the previous year. Bayer AG (BAYRY) faces ongoing litigation challenges, including an adverse decision by the Superior Court of Pennsylvania, which may impact financial provisions and require further legal actions. Q: Could you discuss the expected growth in Crop Science for Q2 and any impacts from forward purchasing on crop protection products? A: Rodrigo Santos, Head of Crop Science, explained that excluding regulatory impacts, the core business would have grown by 2.4%. The corn business is expected to grow by 2.5% in Q1 due to accounting adjustments. Crop protection reported 2% growth, which would be 5% excluding regulatory impacts. The company remains confident in its guidance for the year, driven by innovation and core business health. Q: Can you provide an update on the glyphosate litigation and potential outcomes if the Supreme Court does not accept the case? A: William Anderson, CEO, stated that Bayer expects to hear from the Supreme Court in June or October. The company is not relying solely on this plan and is working with Congress for potential legislative solutions. Bayer is also considering structural options and remains open to settlements, provided they offer a high degree of finality. Q: How confident are you in the safety and efficacy of Asendexian, and what is the expected market potential? A: Stefan Oelrich, Head of Pharmaceuticals, expressed confidence in Asendexian's safety and efficacy, noting positive results from the Pacific program. The Phase III study targets populations with significant effects observed in Phase II. The market potential is substantial, especially if prevalent cases are included. Q: Could you elaborate on the state legislation efforts related to glyphosate and their significance? A: William Anderson highlighted that state legislation is crucial for providing certainty to manufacturers and signaling to Congress the need for federal clarification. Missouri is a key state due to the volume of lawsuits filed there. Bayer is pursuing legislation in additional states to support its position. Q: What are Bayer's expectations for corn acreage in the U.S., and how does it impact profitability compared to soy? A: Rodrigo Santos stated that Bayer is optimistic about high corn acreage in the U.S., potentially reaching 94-95 million acres. Corn is more profitable than soy, and Bayer expects growth in corn globally. The company is also focused on margin expansion through cost control and efficiency improvements. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
29-04-2025
- Business
- Yahoo
UK MHRA authorises BridgeBio's acoramidis for ATTR-CM
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for BridgeBio Pharma's acoramidis under the name Beyonttra, for treating wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is an orally administered selective small molecule that stabilises transthyretin (TTR) by more than 90%. This authorisation was supported by the outcomes from the pivotal ATTRibute-CM Phase III trial, which demonstrated cardiovascular benefits. In the trial, the therapy's safety and efficacy were assessed in 632 symptomatic ATTR-CM subjects, and they were given either the therapy or a placebo for a 30-month period. The primary clinical endpoints were met at month 30, showing a decrease in cardiovascular-related hospitalisations, preservation of functional capacity, improved survival and quality of life for subjects. The therapy received the US Food and Drug Administration's (FDA) approval under the name Attruby in November 2024, and as Beyonttra by the European Commission (EC) in February 2025. It was also approved in Japan by the Ministry of Health, Labour, and Welfare in March 2025. In the UK, Bayer will manage all commercial activities for the therapy. In March 2024, the company and Bayer entered a partnership granting the latter exclusive rights to commercialise the therapy in Europe. According to the licencing agreement, BridgeBio will obtain tiered royalties starting in the low-thirties percent on UK sales after commercialisation efforts commence. ATTR-CM is a fatal condition that causes heart failure due to restrictive cardiomyopathy. BridgeBio Cardiorenal chief medical officer and president Jonathan Fox stated: 'We are proud to add another approval for acoramidis and thrilled that patients in the UK will now have access to Beyonttra since they are in great need of new disease-modifying treatments for their condition. 'We look forward to extending our collaboration with our European partner, Bayer, to serve ATTR-CM patients across the UK and the rest of Europe, and will continue to work towards reaching patients in as many regions as possible around the world." "UK MHRA authorises BridgeBio's acoramidis for ATTR-CM" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
28-04-2025
- Business
- Yahoo
BEYONTTRA® (acoramidis), the First Near-complete TTR Stabilizer (≥90%), Approved by the UK Medicines and Healthcare Products Regulatory Agency to Treat ATTR-CM
- The UK approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date - In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalization (CVH)) durably separated relative to placebo- A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30- A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30 - Acoramidis is the first and only approved ATTR-CM treatment in the U.S., EU, UK and Japan that all have a label specifying near-complete stabilization (≥90%) - Relative increases in serum TTR concentrations resulting from greater TTR stability have been associated with reduced risk of all-cause and cardiovascular mortality in the general population in recent literature1 - BridgeBio will receive royalties in a tiered structure beginning in the low-thirties percent on sales of Beyonttra in the UK PALO ALTO, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) ('BridgeBio' or the 'Company'), a new type of biopharmaceutical company focused on genetic diseases, today announced the Medicines and Healthcare products Regulatory Agency has granted marketing authorization in the United Kingdom (UK) for acoramidis, under the brand name BEYONTTRA®, for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is a selective small molecule, orally administered near-complete (≥90%) transthyretin (TTR) stabilizer. ATTR-CM is a progressive fatal disease that presents as an infiltrative, restrictive cardiomyopathy resulting in heart failure. Bayer will be responsible for all commercial activity for acoramidis in the UK. 'ATTR-CM is a progressive and debilitating disease that poses significant challenges not only for patients but also for the healthcare systems. The condition profoundly impacts patients' quality of life. Symptoms attributable to amyloidosis are usually nonspecific, varied and associated with low awareness, frequently resulting in delayed or completely missed diagnosis,2 which may lead to delayed treatment and a worse prognosis. In the absence of intervention, ATTR-CM causes progressive heart failure leading to increased hospitalizations and escalating healthcare costs and is ultimately fatal,3-5' said Julian Gillmore, M.D., Ph.D., University College London's Centre for Amyloidosis, UK. 'The UK authorization of Beyonttra is welcome news for eligible patients living with the condition. Physicians in the UK now have another treatment option to slow the progression of symptoms and improve outcomes for patients with ATTR-CM.' The approval in the UK is based on results of the pivotal ATTRibute-CM Phase 3 study of acoramidis, which showed clear benefits on cardiovascular outcomes. ATTRibute-CM evaluated the efficacy and safety of acoramidis in 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR who were randomized 2:1 to receive acoramidis or placebo for 30 months. The study met its primary clinical endpoints at month 30 by significantly reducing cardiovascular-related hospitalization, improving survival, and preserving functional capacity and quality of life for patients. 'We are proud to add another approval for acoramidis and thrilled that patients in the UK will now have access to BEYONTTRA since they are in great need of new disease-modifying treatments for their condition,' said Jonathan Fox, M.D., Ph.D., President and Chief Medical Officer of BridgeBio Cardiorenal. 'We appreciate the time and commitment of every clinical trial participant and their families, and the dedicated support of the physicians and scientists involved in the clinical program. This important milestone would not have been possible without their commitment to the program. We look forward to extending our collaboration with our European partner, Bayer, to serve ATTR-CM patients across the UK and the rest of Europe, and will continue to work towards reaching patients in as many regions as possible around the world." Acoramidis was approved as Attruby™ by the U.S. FDA in November 2024 and was approved as BEYONTTRA by the European Commission in February 2025 and the Japanese Ministry of Health, Labour, and Welfare (MHLW) Agency in March 2025 with all labels specifying near-complete stabilization of TTR. In March 2024, BridgeBio and Bayer initiated a collaboration for acoramidis, which granted Bayer exclusive commercialization rights in Europe. Based on terms of the licensing agreement, BridgeBio will receive royalties in a tiered structure beginning in the low-thirties percent on sales of acoramidis in the UK following initiation of commercialization efforts. 1Christoffersen M et al. Transthyretin Tetramer Destabilization and Increased Mortality in the General Population. JAMA Cardiol. 2024 Dec 4:e244102.2Rintell et al. Orphanet J Rare Dis. (2021) 16:70. 3Rozenbaum MH, et al. Impact of delayed diagnosis and misdiagnosis for patients with transthyretin amyloid cardiomyopathy (ATTR-CM): a targeted literature review. Cardiology and therapy. 2021;10:141-59.4Mallus MT and Rizzello V. Treatment of amyloidosis: present and future. 2023;21;25(Suppl B):B99-B103.5Jain A, Zahra F. Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Updated 27 April 2023. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: Last accessed: March 2025. About BEYONTTRABEYONTTRA is an orally administered near-complete (≥90%) stabilizer of transthyretin (TTR) indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). For full prescribing information, please refer to the Summary of Product Characteristics (SmPC) on the Medicines and Healthcare products Regulatory Agency website at About Attruby™ (acoramidis)INDICATIONAttruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. IMPORTANT SAFETY INFORMATIONAdverse ReactionsDiarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively). ▼: This medicine is subject to additional monitoring. This will allow quick identification of new safety information. About BridgeBio BridgeBio is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit and follow us on LinkedIn and Twitter. BridgeBio Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as 'anticipates,' 'believes,' 'continues,' 'estimates,' 'expects,' 'hopes,' 'intends,' 'may,' 'plans,' 'projects,' 'remains,' 'seeks,' 'should,' 'will,' and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the impact of Beyonttra on clinical outcomes; and the potential benefits of Beyonttra, including its ability to reduce cardiovascular-related hospitalization, improve survival, and preserve functional capacity and quality of life, reflect BridgeBio's current views about its plans, intentions, expectations, and strategies, which are based on the information currently available to BridgeBio and on assumptions BridgeBio has made. Although BridgeBio believes that its plans, intentions, expectations, and strategies, as reflected in or suggested by these forward-looking statements, are reasonable, BridgeBio can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties, and assumptions, including, but not limited to, the risks associated with BridgeBio's dependence on third parties for development, manufacture, and commercialization activities related to Beyonttra; government and third-party payor actions; risks and uncertainties relating to competitive products and other changes that may limit demand for Beyonttra; the risk that regulatory authorities may require additional studies or data to support the continued commercialization of Beyonttra; the risk that drug-related adverse events may be observed during commercialization or clinical development; the risk that data and results may not meet regulatory requirements or otherwise be sufficient for further development, regulatory review, or approval; the risk of other regulatory agencies not agreeing with BridgeBio's regulatory approval strategies, components of BridgeBio's filings (such as clinical trial designs, conduct, and methodologies), or the sufficiency of data submitted; the continuing success of its collaborations, including compliance with applicable regulations for the purchase, distribution, storage, export, and sale of active pharmaceutical ingredients and medicinal products; uncertainty regarding any impacts due to global health emergencies, including delays in regulatory review, manufacturing, and supply chain interruptions; adverse effects on healthcare systems and disruption of the global economy; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip; and increasing rates of inflation and changing interest rates on BridgeBio's business operations and expectations. These risks, as well as those set forth in the Risk Factors section of BridgeBio's most recent Annual Report on Form 10-K and its other filings with the U.S. Securities and Exchange Commission, should be carefully considered. Moreover, BridgeBio operates in a highly competitive and rapidly changing environment, in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. BridgeBio Media Contact:Bubba Murarka, EVP Communicationscontact@ Chinmay Shukla, VP Strategic Financeir@
Associated Press
28-04-2025
- Business
- Associated Press
BEYONTTRA® (acoramidis), the First Near-complete TTR Stabilizer (≥90%), Approved by the UK Medicines and Healthcare Products Regulatory Agency to Treat ATTR-CM
- The UK approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date - Acoramidis is the first and only approved ATTR-CM treatment in the U.S., EU, UK and Japan that all have a label specifying near-complete stabilization (≥90%) - Relative increases in serum TTR concentrations resulting from greater TTR stability have been associated with reduced risk of all-cause and cardiovascular mortality in the general population in recent literature1 - BridgeBio will receive royalties in a tiered structure beginning in the low-thirties percent on sales of Beyonttra in the UK PALO ALTO, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) ('BridgeBio' or the 'Company'), a new type of biopharmaceutical company focused on genetic diseases, today announced the Medicines and Healthcare products Regulatory Agency has granted marketing authorization in the United Kingdom (UK) for acoramidis, under the brand name BEYONTTRA®, for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is a selective small molecule, orally administered near-complete (≥90%) transthyretin (TTR) stabilizer. ATTR-CM is a progressive fatal disease that presents as an infiltrative, restrictive cardiomyopathy resulting in heart failure. Bayer will be responsible for all commercial activity for acoramidis in the UK. 'ATTR-CM is a progressive and debilitating disease that poses significant challenges not only for patients but also for the healthcare systems. The condition profoundly impacts patients' quality of life. Symptoms attributable to amyloidosis are usually nonspecific, varied and associated with low awareness, frequently resulting in delayed or completely missed diagnosis,2 which may lead to delayed treatment and a worse prognosis. In the absence of intervention, ATTR-CM causes progressive heart failure leading to increased hospitalizations and escalating healthcare costs and is ultimately fatal,3-5' said Julian Gillmore, M.D., Ph.D., University College London's Centre for Amyloidosis, UK. 'The UK authorization of Beyonttra is welcome news for eligible patients living with the condition. Physicians in the UK now have another treatment option to slow the progression of symptoms and improve outcomes for patients with ATTR-CM.' The approval in the UK is based on results of the pivotal ATTRibute-CM Phase 3 study of acoramidis, which showed clear benefits on cardiovascular outcomes. ATTRibute-CM evaluated the efficacy and safety of acoramidis in 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR who were randomized 2:1 to receive acoramidis or placebo for 30 months. The study met its primary clinical endpoints at month 30 by significantly reducing cardiovascular-related hospitalization, improving survival, and preserving functional capacity and quality of life for patients. 'We are proud to add another approval for acoramidis and thrilled that patients in the UK will now have access to BEYONTTRA since they are in great need of new disease-modifying treatments for their condition,' said Jonathan Fox, M.D., Ph.D., President and Chief Medical Officer of BridgeBio Cardiorenal. 'We appreciate the time and commitment of every clinical trial participant and their families, and the dedicated support of the physicians and scientists involved in the clinical program. This important milestone would not have been possible without their commitment to the program. We look forward to extending our collaboration with our European partner, Bayer, to serve ATTR-CM patients across the UK and the rest of Europe, and will continue to work towards reaching patients in as many regions as possible around the world.' Acoramidis was approved as Attruby™ by the U.S. FDA in November 2024 and was approved as BEYONTTRA by the European Commission in February 2025 and the Japanese Ministry of Health, Labour, and Welfare (MHLW) Agency in March 2025 with all labels specifying near-complete stabilization of TTR. In March 2024, BridgeBio and Bayer initiated a collaboration for acoramidis, which granted Bayer exclusive commercialization rights in Europe. Based on terms of the licensing agreement, BridgeBio will receive royalties in a tiered structure beginning in the low-thirties percent on sales of acoramidis in the UK following initiation of commercialization efforts. 1Christoffersen M et al. Transthyretin Tetramer Destabilization and Increased Mortality in the General Population. JAMA Cardiol. 2024 Dec 4:e244102. 2Rintell et al. Orphanet J Rare Dis. (2021) 16:70. 3Rozenbaum MH, et al. Impact of delayed diagnosis and misdiagnosis for patients with transthyretin amyloid cardiomyopathy (ATTR-CM): a targeted literature review. Cardiology and therapy. 2021;10:141-59. 4Mallus MT and Rizzello V. Treatment of amyloidosis: present and future. 2023;21;25(Suppl B):B99-B103. 5Jain A, Zahra F. Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Updated 27 April 2023. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: Last accessed: March 2025. About BEYONTTRA BEYONTTRA is an orally administered near-complete (≥90%) stabilizer of transthyretin (TTR) indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). For full prescribing information, please refer to the Summary of Product Characteristics (SmPC) on the Medicines and Healthcare products Regulatory Agency website at About Attruby™ (acoramidis) INDICATION Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. IMPORTANT SAFETY INFORMATION Adverse Reactions Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively). ▼: This medicine is subject to additional monitoring. This will allow quick identification of new safety information. About BridgeBio BridgeBio is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit and follow us on LinkedIn and Twitter. BridgeBio Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as 'anticipates,' 'believes,' 'continues,' 'estimates,' 'expects,' 'hopes,' 'intends,' 'may,' 'plans,' 'projects,' 'remains,' 'seeks,' 'should,' 'will,' and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the impact of Beyonttra on clinical outcomes; and the potential benefits of Beyonttra, including its ability to reduce cardiovascular-related hospitalization, improve survival, and preserve functional capacity and quality of life, reflect BridgeBio's current views about its plans, intentions, expectations, and strategies, which are based on the information currently available to BridgeBio and on assumptions BridgeBio has made. Although BridgeBio believes that its plans, intentions, expectations, and strategies, as reflected in or suggested by these forward-looking statements, are reasonable, BridgeBio can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties, and assumptions, including, but not limited to, the risks associated with BridgeBio's dependence on third parties for development, manufacture, and commercialization activities related to Beyonttra; government and third-party payor actions; risks and uncertainties relating to competitive products and other changes that may limit demand for Beyonttra; the risk that regulatory authorities may require additional studies or data to support the continued commercialization of Beyonttra; the risk that drug-related adverse events may be observed during commercialization or clinical development; the risk that data and results may not meet regulatory requirements or otherwise be sufficient for further development, regulatory review, or approval; the risk of other regulatory agencies not agreeing with BridgeBio's regulatory approval strategies, components of BridgeBio's filings (such as clinical trial designs, conduct, and methodologies), or the sufficiency of data submitted; the continuing success of its collaborations, including compliance with applicable regulations for the purchase, distribution, storage, export, and sale of active pharmaceutical ingredients and medicinal products; uncertainty regarding any impacts due to global health emergencies, including delays in regulatory review, manufacturing, and supply chain interruptions; adverse effects on healthcare systems and disruption of the global economy; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip; and increasing rates of inflation and changing interest rates on BridgeBio's business operations and expectations. These risks, as well as those set forth in the Risk Factors section of BridgeBio's most recent Annual Report on Form 10-K and its other filings with the U.S. Securities and Exchange Commission, should be carefully considered. Moreover, BridgeBio operates in a highly competitive and rapidly changing environment, in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. BridgeBio Media Contact: Bubba Murarka, EVP Communications Chinmay Shukla, VP Strategic Finance [email protected]
Yahoo
01-04-2025
- Business
- Yahoo
Bayer eyes launch of menopause relief, heart drugs this year
(Reuters) -Bayer said on Tuesday it was preparing market launches this year of two new drugs that could each have annual peak sales of at least $1 billion, as it seeks to strengthen its pharmaceuticals business amid a high debt burden. In a statement, the German maker of drugs and agricultural supplies said it would bring Beyonttra, also known as acoramidis, to market to treat a condition that results in heart failure. In "late summer" this year, it was eyeing the launch of menopause relief drug elinzanetant to ease hot flashes, it added. It said both had blockbuster potential, an industry term for potential peak annual sales of at least $1 billion. Sign in to access your portfolio
