Tooth Erosion

Strong results to date of Vafseo U.S. launch; expect Vafseo Q1 2025 net product revenues of approximately $10-$11 million Cash resources and cash from operations expected to fund current operating plan for at least two years Akebia to Host Conference Call at 8:00 a.m. ET on March 13, 2025 CAMBRIDGE, Mass., March 13, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the fourth quarter and full year ended December 31, 2024 and recent business highlights. As previously announced, Vafseo® (vadadustat) shipments to customers began January 9, 2025. Akebia expects Vafseo first quarter 2025 net product revenues of approximately $10-$11 million. Commenting on the Vafseo launch, John P. Butler, Chief Executive Officer of Akebia said: “We believe Vafseo can be a new standard of care for the treatment of anemia due to chronic kidney disease (CKD). The U.S. product launch is underway and our initial execution across multiple initiatives demonstrates we are making significant early progress towards that goal for dialysis patients. We launched Vafseo with commercial supply contracts in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S., which we believe is the first time a drug with Transitional Drug Add-on Payment Adjustment (TDAPA) reimbursement has done so. We are very pleased with the early results and expect to generate Vafseo net product revenue of approximately $10-$11 million in the first quarter of 2025.” Mr. Butler continued, “We are also excited about our potential to expand the Vafseo label to the non-dialysis CKD population, and plan to take advantage of the opportunity to meet with the U.S. Food and Drug Administration to discuss the Phase 3 VALOR study protocol. We believe taking the time for this meeting can help drive our efforts to bring a new product to market to treat this underserved patient population. We expect to initiate the VALOR study in the second half of this year.” Vafseo U.S. Commercial Update: Vafseo began shipping to dialysis centers and authorized distributors on January 9, 2025 and the first prescription was written on January 13, 2025.As of today, three of the top four dialysis organizations have placed orders.Through the end of February, more than 500 prescribers have written a prescription for Vafseo and each prescriber, on average, has written approximately 8 prescriptions. Additional Key Business Updates: In December 2024, Akebia announced that U.S. Renal Care enrolled the first patients in VOICE, a collaborative clinical trial of Vafseo designed to assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care. U.S. Renal Care has now enrolled more than half of the total target of 2,200 patients.Vafseo has been recommended for symptomatic anemia in adults undergoing dialysis for CKD by the United Kingdom (U.K.) National Institute for Health and Care Excellence (NICE), a distinction especially relevant for practitioners and commissioners making care choices for patients in the U.K. and of interest globally. Akebia’s partner Medice has now launched Vafseo in the U.K.Akebia plans to initiate a Phase 3 clinical trial (VALOR) to study the use of vadadustat in treating anemia in late-stage CKD patients who are not on dialysis. Akebia expects the VALOR clinical trial to begin in the second half of 2025. Financial Results Revenues: Total revenues were $46.5 million in the fourth quarter of 2024 compared to $56.2 million in the fourth quarter of 2023, and $160.2 million for the full-year 2024 compared to $194.6 million for the full-year 2023. Auryxia® (ferric citrate) net product revenues were $44.4 million in the fourth quarter of 2024 compared to $53.2 million in the fourth quarter of 2023, and $152.2 million for the full-year 2024 compared to $170.3 million for the full-year 2023. These decreases were primarily driven by a reduction in volume, partially offset by price increases and execution of our contracting strategy with third party payors.License, collaboration and other revenues were $2.1 million in the fourth quarter of 2024 compared to $3.0 million in the fourth quarter of 2023, and $8.0 million for the full-year 2024 compared to $24.3 million for the full-year 2023. License, collaboration and other revenue in the full-year 2023 included a one-time $10 million license agreement-related upfront payment. COGS: Cost of goods sold was $20.4 million in the fourth quarter of 2024 compared to $18.7 million in the fourth quarter of 2023, and $63.2 million for the full-year 2024 compared to $74.1 million for the full-year 2023. In the full-year 2024 and during the fourth quarter of 2023, we realized a $12.3 million benefit, and a $4.3 million benefit, respectively, due to our ability to sell inventory previously written down as excess inventory. In addition, the decrease in cost of goods sold in both period-over-period comparisons reflects lower Auryxia sales volumes in 2024 as compared to 2023.R&D Expenses: Research and development expenses were $11.8 million in the fourth quarter of 2024 compared to $9.9 million in the fourth quarter of 2023, and $37.7 million for the full-year 2024 compared to $63.1 million for the full-year 2023. The quarterly increase was driven by expense related to the amendment of our license agreement with Cyclerion. The yearly decrease was driven by the completion of activities related to certain clinical trials, lower headcount-related costs and decreased professional service and consulting expenses.SG&A Expenses: Selling, general and administrative expenses were $27.7 million in the fourth quarter of 2024 compared to $25.4 million in the fourth quarter of 2023, and $106.5 million for the full-year 2024 compared to $100.2 million for the full-year 2023. These increases were driven by costs incurred in connection with preparatory activities related to the Vafseo U.S. launch.Net Income / Loss: Net loss was $22.8 million in the fourth quarter of 2024 compared to net income of $0.6 million in the fourth quarter of 2023. Net loss was $69.4 million for the full-year 2024 compared to $51.9 million for the full-year 2023. The increases in net loss were impacted by lower period-over-period revenues, as well as by non-cash interest expense incurred in 2024 related to the settlement royalty liability in connection with the Vifor Termination and Settlement Agreement we signed in July 2024, which was $4.9 million in the fourth quarter of 2024 and $9.3 million for the full-year 2024.Cash Position: We expect our existing cash resources and cash from operations will be sufficient to fund our current operating plan for at least two years. Cash and cash equivalents as of December 31, 2024, were approximately $51.9 million as compared to $42.9 million as of December 31, 2023. Post year-end, we further strengthened our financial position, including through share sales under our at-the-market facility, which raised $18.4 million. In addition, on February 3, 2025, we elected to access Tranche C of the BlackRock Credit Agreement, resulting in net proceeds of $9.3 million. Conference Call Akebia will host a conference call on Thursday, March 13 at 8:00 a.m. Eastern Time to discuss fourth quarter and full year 2024 earnings. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time. A live webcast of the conference call will be available via the “Investors” section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at https://ir.akebia.com approximately two hours after the event. About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release. About Vafseo® (vadadustat) tablets Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries. INDICATION VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.In patients with anemia due to CKD not on dialysis. IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. CONTRAINDICATIONS Known hypersensitivity to VAFSEO or any of its componentsUncontrolled hypertension WARNINGS AND PRECAUTIONS Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular AccessA rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis. HepatotoxicityHepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease. HypertensionWorsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed. SeizuresSeizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency. Gastrointestinal (GI) ErosionGastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present. Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on DialysisThe safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa. MalignancyVAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea. DRUG INTERACTIONS Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg. USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm.Lactation: Breastfeeding not recommended until two days after the final dose.Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease. Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. Forward-Looking Statements Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia’s commercial supply contract coverage for Vafseo with dialysis organizations and Akebia's ability to make Vafseo available to nearly 100% of patients on dialysis in the U.S.; Akebia's plans and expectations with respect to potential Vafseo label expansion to treat anemia in late-stage CKD patients who are not on dialysis, including Akebia's expectations as to the timing of a Phase 3 trial; Akebia's statements regarding meeting with the FDA to discuss its Phase 3 study protocol; Akebia’s expectation with respect to its net product revenue for the first quarter 2025; Akebia’s plans to establish Vafseo as the new standard of care for dialysis patients with anemia due to CKD and progress towards that goal; Akebia’s expectations regarding the VOICE trial; and Akebia's expectations that its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the commercial availability of Vafseo; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia® and Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia and Vafseo, including potential generic entrants; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce operating expenses; decisions made by health authorities, such as the FDA, with respect to regulatory filings and other interactions; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release. Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates. Akebia Therapeutics Contact Mercedes Carrasco mcarrasco@akebia.com AKEBIA THERAPEUTICS, INC.Consolidated Statements of Operations Quarters Ended December 31, Years Ended December 31, (in thousands, except share and per share data) 2024 2023 2024 2023 Revenues: Product revenue, net$44,370 $53,233 $152,180 $170,301 License, collaboration and other revenue 2,127 2,963 8,000 24,322 Total revenues 46,497 56,196 160,180 194,623 Cost of goods sold: Cost of product and other revenue 11,355 9,656 27,135 38,107 Amortization of intangibles 9,010 9,010 36,042 36,042 Total cost of goods sold 20,365 18,666 63,177 74,149 Operating expenses: Research and development 11,787 9,866 37,652 63,079 Selling, general and administrative 27,674 25,434 106,545 100,233 License expense 978 856 3,220 3,237 Restructuring — — 58 181 Total operating expenses 40,439 36,156 147,475 166,730 Operating income (loss) (14,307) 1,374 (50,472) (46,256)Other income (expense), net (6,822) (761) (18,091) (5,145)Change in fair value of warrant liability (1,675) — (330) — Loss on extinguishment of debt — — (517) — Loss on lease termination — — — (524)Net income (loss)$(22,804) $613 $(69,410) $(51,925)Net income (loss) per share Basic and diluted$(0.10) $— $(0.33) $(0.28)Weighted-average number of common shares outstanding:Basic 218,699,008 189,903,365 210,946,658 187,465,448 Diluted 218,699,008 190,496,470 210,946,658 187,465,448 Selected Balance Sheet Data(unaudited) December 31, (in thousands) 2024 2023 Cash and cash equivalents $51,870 $42,925 Working capital $32,917 $18,279 Total assets $220,670 $241,703 Total stockholders’ (deficit) equity $(49,185) $(30,584)

Driven by the increasing prevalence of dental problems along with the rising focus on physical attraction and surging demand for cosmetic dentistry, the Global Dental Consumables Market is forecasted to reach nearly US$ 45 Bn by 2028 says Ken Research Study. GURUGRAM, India, June 27, 2023 /PRNewswire/ -- Dental Consumables are defined as products used by dental professionals on patients to treat or perform dental procedures associated with diagnostic, restorative, preventive, and emergency oral health issues. Dental hospitals & clinics, and laboratories are the major end-user of dental consumable products. The demand for dental consumables is increasing globally to treat and diagnose various dental problems including tissue problems, dental caries, dental impairment, and others. The increasing focus on physical appearance is driving the demand for dental consumables to perform cosmetic dentistry, which is expected to propel the growth of the market. Ken Research shares 5 key insights on this high opportunity market from its latest research study. According to Ken Research estimates, the Global Dental Consumables Market – estimated to be around US$ 30 Bn in 2022 – is expected to grow further into around US$ 45 Bn opportunity by 2028. 1. Dental Consumables Market is expected to see Stable Growth owing to Rising Prevalence of Dental Problems The global dental consumables market is expected to witness stable growth during the forecast period owing to the growing cases of dental problems or disorders including tooth erosion, tooth decay, gum diseases, mouth sores, and others. The increase in the geriatric population who are more prone to dental disorders due to increased gingival recession that exposes the surface of the roots and chronic diseases along with degenerative diseases makes older people more prone to dental infections. In addition, increasing focus on oral hygiene globally is anticipated to fuel the growth of the market. In March 2022, according to World Health Organization (WHO), around 2 billion people are suffering from dental caries of permanent teeth globally and 520 million children are suffering from caries of primary teeth. 2. Advancements in Dental Technologies is the Major Growth Driver for the Global Dental Consumables market The advanced technology has the potential to reshape the dental industry by transforming treatments and making the process faster, simpler, and more efficient which eventually improves the customer experience. CAD/CAM is the latest technology in the dental industry, which uses software that makes it possible for dentists to perform complex dental surgeries more efficiently, accurately, and faster. CAD/CAM is gaining popularity among end users like hospitals, clinics, and laboratories specially to construct restorations like veneers, bridges, inlays, crowns, dentures, implant-supported restoration from high-strength ceramic, and others. The introduction of new technologies to make dental procedures more efficient, fast, and accurate is anticipated to fuel the growth of the market in the forecasted period. In February 2022, Planmeca USA launched a new wet/dry chairside mill named the Planmeca PlanMill 35. It is one of the three key components of the FIT CAD/CAM system and is perfect for dentists who are looking to provide single-visit dentistry to their patients. It allows dentists to select materials from glass, zirconia, hybrid ceramics, composites and more and also provides improved accuracy, high speed, and ease of use in the scanning process. According to IOPscience, the below figure depicts the patient satisfaction level of getting dental treatment with the help of CAD/CAM technology. The survey of patient satisfaction was conducted by IOPscience in Bosnia and Herzegovina 100 patients participated in the survey and gave their feedback and it was found that 75.20% reached the highest level of satisfaction with the use of new technology. Interested to Know More about this Report, Request a Free Sample Report 3. High Cost of Dental Treatments is the Most Significant Barrier The high cost associated with dental treatments, procedures, and consumables along with the lack of proper reimbursement policies for dental surgeries and implants is expected to restrict the growth of the market. The dental equipment including the dental chair, X-ray machines, connection to the compressor, surgical tools, materials, and medications like anesthesia and others contributes to the extravagant cost. Moreover, the maintenance of equipment, rent of hospital or clinics, electricity, technology, and others also adds up to the cost. In addition, it's hard to afford expensive dental treatments, especially in developing countries. According to The Board of Trustees of the University of Illinois, the treatment for gum diseases cost between USD 500 to USD 10,000 depending on the severity of the disease. More complicated treatments like crowns can cost between USD 600 to USD 1,000 and implants can cost around USD 2,000 or more. 4. Dental Hospitals & Clinics hold the major share in the End-User segment Among the end-user segments, dental hospitals & clinics remained the dominant segment during the 2017-2021 period contributing to maximum market revenue share. Further, the Research Study found that this segment is likely to retain dominance even by 2028. Its dominance is owing to the growing number of dental hospitals and clinics globally along with the increasing adoption of new and advanced technologies by small and large dental clinics and hospitals. Moreover, the increase in dental tourism in emerging markets is anticipated to boost the demand for the segment in the market. In addition, companies are taking initiatives to develop portable dental clinics to provide oral healthcare services, which is expected to fuel the growth of the market. In April 2022, Clowak Innovations a dental tech start-up based in Tamil Nadu, developed a complete set of compact " Portable Dental Clinic" (PDC) to fill the gap in the transportation of dental care in remote areas. PDC supports dentists to reach geriatric patients and pregnant women in remote areas. Visit this Link:- Request for custom report 5. North America region is expected to Dominate the Dental Consumables Market. North America region holds maximum market share and dominates the industry owing to a strong presence of a large number of dental consumables manufacturers coupled with the rising prevalence of dental caries among North American consumers. The increase in disposable income along with rising awareness regarding oral hygiene or care is expected to boost the growth of the market in the region. Furthermore, manufacturers of dental consumables are actively involved in strategic developments such as partnerships, acquisitions, launches, and others, which are further expected to augment the growth of the region in the dental consumables market. In August 2022, Henry Schein, Inc. acquired Midway Dental Supply, a full-service distributor of dental products to clinics and hospitals across the U.S. The acquisition aimed to expand its business in the U.S. and bring new customers on board. The Research study shows that the increasing prevalence of dental problems globally along with rising awareness about oral health among consumers is increasing the demand for dental treatment, diagnoses, and others in the region are anticipated to augment the growth of the dental consumables market in North America. Request free 30 minutes analyst call Market Taxonomy By Treatment Orthodontic Endodontic Periodontics Prosthodontic By Product Type Dental Implants Whitening Products Finishing & Polishing Products Other Dental Consumables By Materials Metals Polymers Ceramics Biomaterials By End-User Dental Hospitals & Clinics Dental Laboratories Others By Geography North America The U.S. Canada Mexico Europe Germany The U.K. France Spain Italy Rest of Europe Asia-Pacific China Japan South Korea India Indonesia Australia Rest of Asia-Pacific LAMEA Latin America The Middle East Africa For more insights on market intelligence, refer to the link below: – Global Dental Consumables Market Related Reports By Ken Research:- Global Respiratory Devices Market Outlook to 2027 Segmented by- product type (Respiratory Consumables, Nebulizers, Oxygen Concentrators, Positive Airway Pressure Devices), by Distribution Channel (Online, Offline), by Country (US, Canada, Mexico, Brazil, Argentina, Rest of South America, Germany, France, Italy, U.K., Belgium, Spain, Russia, Turkey, Netherlands, Switzerland, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific, U.A.E, Saudi Arabia, Egypt, South Africa, Israel, Rest of Middle East and Africa), by end-user (Hospitals, Clinics, Others) According to Ken Research estimates, the Global Respiratory Devices market which grew at a robust CAGR from 2017-2022 & is forecasted to grow steadily from 2022-2027 driven by increase in respiratory illness cases, innovative technologies alongside growing inorganic growth strategies. The rapid growth in global geriatric population, rising incidents of chronic diseases (including COPD & asthma), alongside the cost advantage of home care devices & services are the key factors driving the global respiratory devices market. US Medical Devices Market Outlook to 2027 by type (Orthopaedic, Cardiovascular, Diagnostic Imaging devices, IVD Devices, MIS Devices, Nephrology Devices, Wound Care, Diabetes Care), by End-User (Hospital, ambulatory service centres, clinics & others) According to Ken Research estimates, the US Medical Devices Market which grew at a robust CAGR from 2017-2022 & is forecasted to grow steadily from 2022-2027 driven by rising technological implementation, cosmetic procedure market impacting the trends & increasing chronic lifestyle diseases. The report has market segmentation which include segments by type of segment & by End-User. The report includes Porter's five force analysis, growth enablers, recent trends & developments, pain points & solutions. The report concludes with future market projections of each market segmentation and analyst recommendations. India POCT Market Outlook to 2027F Driven by the increasing incidence of chronic diseases, rising awareness of rapid diagnosis in India According to Ken Research estimates, the India POCT Market – which grew from approximately ₹ ~2000 Crore in 2017 to approximately ₹ ~5000 Crore in 2022 – is forecasted to grow further into ₹ ~11,000 Crore opportunity by 2027F, owing to the increasing demand for rapid and accurate diagnosis, rising awareness, and increasing government initiatives in India. China is the biggest exporter with a 22% contribution to the import of medical Instruments and consumables followed by the USA and Germany with 18% and 10% respectively. KSA Medical Devices Market Outlook to 2026 –Driven by increasing prevalence of chronic diseases, growing healthcare awareness and rising healthcare budget in the country The KSA medical device market is expected to a positive growth in revenue in 2026, with imports contributing highest share to the market revenues. Changes in population composition will drive future healthcare requirements and will create demand for a number of specialisms; pediatrics, lifestyle diseases, long-term care, rehabilitation, home care, and rejuvenation services. Government is planning to invest in private sector integration to create effective strategic partnerships in the pursuit of national health objectives and promotion of fair and comprehensive geographical coverage across all regions of the Kingdom. Follow Us – LinkedIn | Instagram | Facebook | Twitter | YouTube Contact Us:- Ken Research Private Limited Ankur Gupta, Director Strategy and Growth [email protected] +91-9015378249 Logo: SOURCE Ken Research

Four new indications added for tislelizumab and all nine approved indications now included in NRDL KYPROLIS® included for the first time XGEVA® successfully renewed CAMBRIDGE, Mass. & BASEL, Switzerland & BEIJING--(BUSINESS WIRE)-- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include four new indications for its PD-1 inhibitor tislelizumab. KYPROLIS® (carfilzomib), a proteosome inhibitor licensed-in from Amgen, is included for the first time and XGEVA® (denosumab), a RANKL inhibitor and another Amgen asset, successfully renewed this year. The updated NRDL will officially take effect on March 1, 2023. “The expanded coverage of tislelizumab, new inclusion of KYPROLIS, as well as the renewal of XGEVA on the latest NRDL will allow more patients in China to have access to these high-quality medicines at affordable prices,” said Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China, at BeiGene. “After several years of reform, the NHSA has established a basic medical insurance system with universal coverage. Through the annual updates of the NRDL, it made a leap forward in broadening access to innovative oncology medicines across China. At BeiGene, we share this same vision and endeavor to advance global health by making innovative medicines more accessible and affordable to patients in China and globally.” The following medicines and indications have been included in the updated NRDL Tislelizumab is now included in four new indications in NRDL: For the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who are negative for epidermal growth factor receptor (EGFR) and anaplastic mesenchymal lymphoma kinase (ALK) mutations and have progressed after or are intolerant of prior chemotherapy with platinum-containing regimens; and adult patients with locally advanced or metastatic squamous NSCLC who are negative or unknown for EGFR and ALK mutations and have progressed after or are intolerant of prior chemotherapy with platinum-containing regimens. For the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors: patients with advanced colorectal cancer with disease progression after prior treatment with fluoropyrimidines, oxaliplatin and irinotecan; patients with other advanced solid tumors with disease progression after prior treatment and no satisfactory alternative treatment options. For the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma who have progressed after or are intolerant of prior first-line standard chemotherapy. As a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer. KYPROLIS is now included in its approved indication For the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent. XGEVA is successfully renewed in NRDL For the treatment of patients with giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity (first included in NRDL in 2020). About Tislelizumab Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fcγ receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. Tislelizumab is the first investigational medicine from BeiGene’s immuno-oncology biologics program and is being evaluated in solid tumor and hematologic malignancies, as monotherapy and in combination. The global tislelizumab clinical development program includes more than 11,500 subjects enrolled to-date in 21 registration-enabling trials, from more than 30 countries and regions. Biologics License Applications (BLA) for tislelizumab are under review with U.S. and European Union (E.U.) regulators; for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the U.S.; for non-small cell lung cancer and unresectable recurrent locally advanced or metastatic ESCC in the E.U. About KYPROLIS® (carfilzomib) for injection Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.1 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.2 In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.1,2 Since its first approval in 2012, approximately 200,000 patients worldwide have received KYPROLIS.3 KYPROLIS is approved in the U.S. for the following: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. KYPROLIS is also approved in more than 40 markets including Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, European Union, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Oman, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, S. Africa, S. Korea, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom. U.S. KYPROLIS® (carfilzomib) Important Safety Information Cardiac Toxicities New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration. Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment. While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate. For patients ≥ 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management. Acute Renal Failure Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency adverse events (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate. Tumor Lysis Syndrome Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold until resolved. Pulmonary Toxicity Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug–induced pulmonary toxicity, discontinue KYPROLIS. Pulmonary Hypertension Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment. Dyspnea Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment. Hypertension Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment. Venous Thrombosis Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Thromboprophylaxis is recommended for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient's underlying risks. Patients using hormonal contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment. Infusion Reactions Infusion reactions, including life–threatening reactions, have occurred. Signs and symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms and seek immediate medical attention if they occur. Hemorrhage Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate. Thrombocytopenia KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate. Hepatic Toxicity and Hepatic Failure Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate. Thrombotic Microangiopathy Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome, have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known. Posterior Reversible Encephalopathy Syndrome (PRES) Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known. Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma. Embryo-fetal Toxicity KYPROLIS can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS and for 3 months following the final dose. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus. Adverse Reactions The most common adverse reactions in the combination therapy trials: anemia, diarrhea, fatigue, hypertension, pyrexia, upper respiratory tract infection thrombocytopenia, cough, dyspnea and insomnia. The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral. Please see accompanying full Prescribing Information at . About XGEVA® (denosumab) XGEVA targets the RANK ligand pathway to prevent the formation, function and survival of osteoclasts, which break down bone. XGEVA is indicated for the prevention of SREs in patients with bone metastases from solid tumors and for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. XGEVA is also indicated in the U.S. for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. XGEVA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. XGEVA U.S. Important Safety Information Hypocalcemia Pre-existing hypocalcemia must be corrected prior to initiating therapy with XGEVA®. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Monitor calcium levels, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be closely monitored. Advise patients to contact a healthcare professional for symptoms of hypocalcemia. An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake. Hypersensitivity XGEVA® is contraindicated in patients with known clinically significant hypersensitivity to XGEVA®, including anaphylaxis that has been reported with use of XGEVA®. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue XGEVA® therapy permanently. Drug Products with Same Active Ingredient Patients receiving XGEVA® should not take Prolia® (denosumab). Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ) has been reported in patients receiving XGEVA®, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure. Patients with a history of tooth extraction, poor oral hygiene, or use of a dental appliance are at a greater risk to develop ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections. Perform an oral examination and appropriate preventive dentistry prior to the initiation of XGEVA® and periodically during XGEVA® therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with XGEVA®. Consider temporarily interrupting XGEVA® therapy if an invasive dental procedure must be performed. Patients who are suspected of having or who develop ONJ while on XGEVA® should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Atypical Subtrochanteric and Diaphyseal Femoral Fracture Atypical femoral fracture has been reported with XGEVA®. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During XGEVA® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of XGEVA® therapy should be considered, pending a risk/benefit assessment, on an individual basis. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with Growing Skeletons Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in XGEVA®-treated patients with GCTB and in patients with growing skeletons within one year of treatment discontinuation. Monitor patients for signs and symptoms of hypercalcemia after treatment discontinuation and treat appropriately. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation Multiple vertebral fractures (MVF) have been reported following discontinuation of treatment with denosumab. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When XGEVA® treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures. Embryo-Fetal Toxicity XGEVA® can cause fetal harm when administered to a pregnant woman. Based on findings in animals, XGEVA® is expected to result in adverse reproductive effects. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of XGEVA®. Apprise the patient of the potential hazard to a fetus if XGEVA® is used during pregnancy or if the patient becomes pregnant while patients are exposed to XGEVA®. Adverse Reactions The most common adverse reactions in patients receiving XGEVA® with bone metastasis from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction was dyspnea. The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia. For multiple myeloma patients receiving XGEVA®, the most common adverse reactions were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction was pneumonia. The most common adverse reaction resulting in discontinuation of XGEVA® was osteonecrosis of the jaw. Please see accompanying full Prescribing Information at . About BeiGene BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 9,000 colleagues spans five continents, with administrative offices in Cambridge, U.S. & Basel, Switzerland & Beijing, China. To learn more about BeiGene, please visit and follow us on Twitter at @BeiGeneGlobal. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential for the inclusion in the NRDL of tislelizumab, KYPROLIS and XGEVA to expand patient access and affordability, BeiGene’s ability to advance global health by making innovative medicines more accessible and affordable for more patients globally, and BeiGene’s plans, commitments, aspirations and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. KYPROLIS® and XGEVA® are registered trademarks of Amgen. REFERENCES Moreau P, Richardson PG, Cavo M, et al. Proteasome inhibitors in multiple myeloma: 10 years later. Blood. 2012 Aug 2;120(5):947-59. Kortuem KM and Stewart AK. Carfilzomib. Blood. 2013 Feb 7;121(6):893-7. Amgen Data on File.