PowerPoint 프레젠테이션

[Audio] Good morning everyone. Today we are here to discuss our company's plan to transform the mBC Tx landscape with the goal of advancing patient outcomes. We will be discussing regulatory approvals reimbursement for targeted treatments raising awareness of Her2 Low and establishing ENHerTU as the standard of care for eligible Her2-low mBC patients. Let's begin..

[Audio] Our objective is to transform the mBC Tx landscape by gaining regulatory approvals and reimbursement for targeted treatments raising awareness of Her2 Low and establishing ENHerTU as the standard of care for eligible Her2-low mBC patients to improve patient outcomes. In 2024 we will aim for DB-04 regulatory approval and a patient access program for early patient access while increasing awareness of Her2 Low and setting it as a routine practice. In 2025 we will focus on improving patient outcomes in Her2-low mBC by treating earlier such as after endocrine therapy instead of first chemotherapy. Our ambition is to gain DB-06 regulatory approval and a patient access program as well as shift ENHerTU ahead of chemo and maximize patient access with Her2low reimbursement in the years 2026 to 2028. We also intend to develop an innovative reimbursement strategy and shape the environment and to attain ENHerTU reimbursement for DB-04 and DB-06..

[Audio] This slide presents the timeline for regulatory approvals and reimbursement for targeted treatments. ENHerTU is the standard of care for eligible Her2-low mBC patients and the objective is to improve patient outcomes. In 2023 the plan is to gain Regulatory Approval and Reimbursement for Her2 plus mBC 3l and the 1st Wave of P&R in the first four quarters. In 2024 Regulatory Approval for Her2 plus aGC 3 liters with the 3-month accelerated timeline is expected between January and May followed by Reimbursement for Her2 plus mBC 2 liters during April and May. The focus of 2025 is to gain Regulatory Approval for Her2low mBC 3 liters and the 2nd Wave of P&R to be determined in each of the four quarters. The goals for 2026 include Regulatory Approval for Her2 meters N-S-C-L-C from January to July Her2 plus Solid Tumors from August to February Her2low/HR plus mBC 2 liters (post ET) from September to March and the 5th RA in the first four quarters..

[Audio] It is essential to recognize and address Her2-low mBC as a distinct disease. With ENHerTU and other medicines in development we can now offer treatments specific for patients with Her2-low mBC and diverge from the traditional practice of treating all patients as if they had Her2-positive disease. For Her2-low mBC patients to get the right treatments Her2-low scoring must be standardized and embedded into everyday practice. Our initiative of enforcing ENHerTU as the Standard of Care across eligible Her2-low mBC patients will enable us to ensure regulatory approvals and reimbursement as well as increased awareness about Her2-Low mBC and a change in healthcare professionals’ attitude toward the disease..

[Audio] Korea BC Incidence in 2024 is predicting that 30 8 thousand patients will be eligible for Her2low mBC treatment. To further increase the binary classification of Her2 testing a new segment of Her2 low patients must be established. Establishing routine practice of Her2low identification for 94% of all operable St1-III mBC patients is essential for early detection of Her2 Low which is key for delivering unpreceded survival. Additionally ENHerTU is recommended as the first and only targeted therapy to 65% of patients allowing physicians to be confident in managing treatment-associated adverse events resulting in wider usage of this treatment that will consequently increase survival and better outcomes for mBC patients in Korea..

[Audio] By 2026 Korea BC Incidence is projected to reach 33.5K patients and it is expected that Her-Test will be applied to 99% of them. Our goal is to capitalize on the key prospects presented in the early and metastatic Her2-low metastatic breast cancer (mBC). We propose to expand the binary classification by recognizing Her2 plus & HR-/Her2 mBC while also making Her2Low an independent segment and standardizing Her2Low recognition. Our proposal is to replace the common initial chemotherapy regimen with first-line CDK4/6 targeted therapy for eligible ENHerTU-patients with Her2-low mBC as it presents a greater clinical profile compared to first chemo ET/CT/Others. This measure could potentially provide unprecedented survival rates for Her2 Ultra-low patients by introducing ENHerTU at earlier stages edging out the traditional ET practice and ultimately reducing suboptimal ET cycling. This could potentially lead to an improvement in the survival of 122 Her2-low patients..

[Audio] In order to meet our Strategic Imperatives and Critical Success Factors we have three main objectives. These are to enforce ensure and establish. To enforce is to make sure that ENHerTU obtains regulatory approval by the due date of May 24th. To ensure is to encourage healthcare professionals to provide ENHerTU Early in contrast to traditional chemotherapy and endocrine therapy and to create a new segment of Her2-low and set Her2-low identification as standard practice. As for establishing we wish to give patients access to ENHerTU during the non-reimbursement period create confidence with less toxicity caused by ENHerTU and raise public awareness of the clinical value of ENHerTU in Her2-low mBC as well as increase treatment willingness with out-of-pocket payments. To help reach our goals we must complete nationwide formulary listing support pathologists in their standardized Her2-low identification and put into effect a “better option first” policy that prioritizes patient status performance through right sequencing..

[Audio] Today the author's company is launching an ambitious project to bring better outcomes for Her2-low mBC patients by making ENHerTU the standard of care. To achieve this we have created a set of programs and activities to be held in various locations and occasion to help HCP’s understand the scientific value of ENHerTU and to increase the awareness of DB-03 reimbursement and DB-04 launch to the public and medical society. The activities include a luncheon and satellite ENHerTU press conference as well as a launch symposium in May a satellite event in August and a symposium in September to provide a right sequencing and better option first and to support pathologists to perform Her2 scoring with strengthened capabilities. Together we will work towards making ENHerTU the standard of care to improve patient outcomes in Her2-low mBC..

[Audio] The goal of this presentation is to demonstrate how we can revolutionize the way we treat Her2 Low mBC patients. We need to strengthen confidence in ENHerTU the personalized treatment that is suitable for Her2 Low patients and to replace the traditional chemotherapy and endocrine therapy treatments with it as the first and only targeted treatment delivering unprecedented survival outcomes. We must effectively communicate the benefits of ENHerTU to both medical oncologists and patients through case sharing patient education leaflets and support videos. In addition we must raise awareness of Her2 Low population as a new targetable patient population and set Her2 Low identification as a routine practice. Furthermore we must provide support for ENHerTU patients in better understanding and monitoring side effects to maximize the clinical benefits of ENHerTU with optimal AE management. This will ensure that we are transforming the mBC Tx landscape and advancing patient outcomes.”.

[Audio] To maximize patient outcomes among Her2-low mBC patients an effective approach is to ensure their correct identification. We plan to implement a comprehensive strategy that includes tailored multi-disciplinary teams and activities to raise awareness as well as to guide providers in navigating Her2-low mBC. Mass media activities will be used to inform the public about the ENHerTU benefit in Her2-Low mBC. Through the “ENHANCE Patients Experience” lecture we aim to reach at least 200 Her2-low mBC patients and to redefine how they are classified and treated. We also support oncologists with radio activities to increase their willingness to treat Her2-low patients with ENHerTU. In addition we are assisting pathologists to optimize Her2 testing processes to accurately identify patients eligible for treatment. The programs and activities we are implementing are aimed to establish Her2-Low as a new segment and ENHerTU as the standard of care for eligible Her2-low mBC patients in order to improve patient outcomes..

[Audio] To unlock the potential of ENHerTU patient access must be achieved. Our strategic deployment plan was created to ensure eligible patients have access to targeted mBC Tx treatments. The ENHerTU Refund Program was created to provide access to Her2-low mBC patients during the non-reimbursement period. From January to April of 2024 6 F-T-E-s are allocated for the Alliance in AZ and 14 F-T-E-s are allocated for AZ and DS. We are actively working to quickly gain ENHerTU DB-04 2023 reimbursement secure the necessary regulatory approval in May of 2024 and push to finish nationwide formulary listing in 28 hospitals. Through the ENHerTU Refund Program patients treated within other approved but non-reimbursed indications can be refunded at the same rate as the R-S-A contract. DS and our agency I-Q-V-I-A are running the program. The necessary steps are being taken to ensure eligible patients have broad access to ENHerTU..

[Audio] By 2024 our launch readiness plan for Her2-Low metastatic breast cancer is progressing. We are working to secure regulatory approval and reimbursement for targeted treatments as well as raising public awareness of Her2-Low. The next step is to establish ENHerTU as the standard of care for eligible Her2-Low breast cancer patients. To advance our objectives we will be attending conferences such as the Best of ASCO ESMO Global Breast Cancer Conference and the Korea Society of Medical Oncology Spring Activity. Additionally we are organizing regional breast cancer events Her2 Diagnostics symposiums and a Launch Symposium. We are also engaging the medical community through invited lectures webinars and ABM Events. To create a patient-centric brand message campaign for Her2 plus we are using advertisements featured articles and patient stories. Ultimately our aim is to give ENHerTU the recognition it deserves in order to improve the outlook for Her2-Low metastatic breast cancer..

[Audio] Our plan is to maximize ENHerTU's revenue over the five year period of 2024-2028 reaching a peak of 62 million U-S-D up from 235 million U-S-D in total. This will be accomplished by maximizing DB-03/DG-01 reimbursement by 2024 achieving 70 million U-S-D in sales with DB-04/DL-02 regulatory approval and ensuring DB-06 regulatory approval and P-A-P for early patient access by 2025. We will also strive to improve treatment outcomes in Her2-low mBC positioning ENHerTU ahead of chemo therapy while highlighting the high unmet need with CT and ET overtreatment. Additionally we will strengthen our leadership with Her2-low reimbursement and extended indications throughout 2024-2028. To maximize patient access we aim to use reimbursement and indication expansion with Her2low S-O-B reaching 29%. Finally we hope to maximize GC sales from 1.3 meters U-S-D in 2024 to 8 meters U-S-D by 2028..

[Audio] Our diagnostic tools are essential for correctly identifying Her2-low mBC patients. We are dedicated to improving diagnostics in various ways like increasing access to testing and optimizing laboratory standardization and quality. We are firmly devoted to researching further possibilities to enhance our diagnostic processes. With dependable and accessible diagnostics we can guarantee that the right treatments are provided to the appropriate patients leading to better patient outcomes..

[Audio] Korea is facing a major challenge in the differentiation of Her2 Low from IHC 0 and IHC 1 plus . Despite the current ASCO/CAP guidelines not providing a clear definition or criteria for interpretation pathologists still attempt to interpret such results correctly but are faced with staining issues. The situation is even worse at prestigious hospitals such as Asan Medical Center and Sevrance Hospitals who are currently labeling Her2-Low results as Her2 Positive and Her2 Negative. This emphasizes the need for capability building for Her2-Low which our company is looking to cater for. With data collected from 25 centers in Korea from 11 657 cases the prevalence of Her2-Low was 18.2% with a maximum variance of 77%. Therascreen a companion diagnostic test having been approved this is an ideal opportunity to bring a shift in the mBC Tx landscape in Korea..

[Audio] Our goal is to provide physicians and pathologists with the necessary information and resources to guarantee accurate interpretations of Her2-Low cases. To achieve this aim we are developing an expert advocacy group offering pathologists training on sample handling and interpretation and creating Her2-Low Interpretation Workshops and Quality Programs. We will also generate greater awareness of Her2-Low cases through educational symposiums and activities. With a correct understanding of pre-analytical factors enhanced accuracy of I-H-C scores and the suitable educational and regulatory actions we can ensure that targeted treatments and ENHerTU become standard care for appropriate Her2-Low mBC patients ultimately improving their outcomes..

[Audio] We plan to revolutionize the mBC Tx landscape by obtaining regulatory approval and reimbursement for specific treatments fostering increased awareness of Her2 Low and setting ENHerTU as the preferred treatment choice for eligible Her2-low mBC patients to promote better patient outcomes. To accomplish this we will need to locate and identify all ENHerTU-eligible patients raise understanding of Her2 Low as a new targetable patient population in addition to Her2 and maintain high quality Her2 testing and improved Her2 test processing. We will also raise the capacity of pathologists by providing an array of educational activities such as peer to peer meetings workshops and Her2 symposium material. These activities will guarantee precision in Her2 classification and preanalytical considerations for Her2 assessment in addition to improving the quality of the test and pathologist expertise. Also a proposed algorithm for establishing Her2-Low will be put forward which will aid in setting up improved Her2 test processing in each hospital. In the end this will allow us to deliver timely accurate and high quality test results for all breast cancer patients and help guarantee they receive the best treatment option available..

Activity 2023 2024 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec AWAR- NESS HER2-Low Prevalence data generation HER2 Symposium (F2F) HER2 Survey by Dx team Materials INTER- PRE- TATION Find HER Symposium (F2F) Interpretation Masterclass QUALITY RCPA QAP Tailored account education with MDT CONGRESS 18 HER2 BC Dx tactical plan schedule HER2-Low RA Apr 2024 Expected Feb Concept generation Mar to June IRB submission & Data Collection June to Nov Data Analysis Apr FIND HER symposium Interim- analysis Data sharing Intl HER2-Low Interpretation workshop (Webinar) Intl Interpretation Masterclass (F2F) Fall Conference (International) Pathologists(3): • IHC Interpretation guide • HER2 Low identification • Reporting guide Oncologists(1) Tailored Account Education for MDT Set optimal Dx environment to find all HER2-Low patients HER2-Low Interpretation workshop (Webinar) Survey 25 PATHs participated 72% accuracy Publication CRT submitted Final Data sharing 16 PATHs participation.

[Audio] Our team has developed the Her2 Low Clinical Initiative plan which provides clear guidance on regulatory approvals and reimbursement for targeted treatments as well as raising awareness of Her2 Low to ensure ENHerTU as the standard of care for eligible Her2-low mBC patients. We aim to improve patient outcomes and create positive outcomes for the mBC Tx landscape by taking this proactive step forward for mBC and patient care. We invite further discussion on this initiative..

[Audio] ENHerTU has the advantage of being a targetable agent for Her2-low mBC patients and a mode of action that can kill adjacent tumor cells regardless of Her2 expression with clinical trials demonstrating a median progression-free survival of 10.1 months and overall survival of 23.9 months. AE management concerns exist for a small percentage of people and I-L-D is a concern that can be particularly difficult to treat and potentially fatal along with other side effects such as emetogenic effects fatigue and alopecia. To take advantage of the opportunities collaborations between DS/AZ and H-C-P-s should be established to leverage awareness excitement positive experience and data to advance the standard of care. The main threats to ENHerTU include emerging data from competitors with other modes of action and an expanding guideline inclusion so it is important to keep ENHerTU as the strongest option for Her2-low patients..

[Audio] For patients with Her2-low metastatic breast cancer the existing treatments available were not providing much benefit. However ENHerTU is now a new standard of care that provides much better clinical outcomes and improved treatment-risk profile. Data shows it has increased progression-free survival overall survival and response rate while also improving quality of life for patients regardless of hormone receptor status. This new therapy is revolutionising our comprehension of Her2-low metastatic breast cancer and acknowldeging Her2-low as a targetable patient segment and a viable therapeutic opportunity. With improved diagnosis strategies Her2-low is now detectable more easily making it possible for more people to benefit from ENHerTU..

[Audio] We plan to establish T-DXd as the standard of care in Her2-low BC to address unmet needs. To achieve this we will collaborate with Key External Experts and engage them in scientific exchanges. Additionally we will provide internal C-F-T training bring external experts and investigators to local evidence generation and organize an Onco Leaders' Summit in October. Furthermore we will contribute to clinical trials provide 1:1 field medical interaction and effectively communicate the value of ENHerTU..

EOD.