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Merck Announces Outcome of Oncologic Drugs Advisory Committee (ODAC) for KEYTRUDA® (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)

On February 9, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the outcome of today’s meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which discussed the supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant (pre-operative) treatment, then as a single agent as adjuvant (post-operative) treatment after surgery for patients with high-risk early-stage triple-negative breast cancer (TNBC) (Press release, Merck & Co, FEB 10, 2021, View Source [SID1234575051]). The committee voted 10-0 that a regulatory decision should be deferred until further data are available from the Phase 3 KEYNOTE-522 trial. The study met one of the dual primary endpoints of pathological complete response (pCR) and is continuing to evaluate event-free survival (EFS). The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA is not bound by the committee’s guidance but takes its advice into consideration.

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"Triple-negative breast cancer is an aggressive disease, and we all agree that patients with early-stage disease are in need of more options," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "While we are disappointed in the outcome of today’s meeting, we believe KEYTRUDA can help meet the significant unmet medical need for these patients. We are confident in the results seen thus far from the KEYNOTE-522 trial, including the pathological complete response rates observed and the encouraging interim event-free survival data. We look forward to continuing to work with the FDA on its review of our application. We thank all of the patients, caregivers and health care providers who are participating in this study."

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 29, 2021. The next interim analysis is calendar-driven, and data is expected in the third quarter of 2021.

About Triple-Negative Breast Cancer

Triple-negative breast cancer is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. Approximately 15-20% of patients with breast cancer are diagnosed with TNBC.

About KEYNOTE-522

The filing was based on data from KEYNOTE-522 (ClinicalTrials.gov, NCT03036488), a Phase 3, randomized, double-blind trial evaluating a regimen of neoadjuvant KEYTRUDA in combination with chemotherapy followed by adjuvant KEYTRUDA as monotherapy versus a regimen of neoadjuvant chemotherapy followed by adjuvant placebo. The dual primary endpoints are pCR and EFS. The secondary endpoints include pCR rate using alternative definitions (i.e., no invasive or noninvasive residual cancer in breast or nodes) at the time of definitive surgery, overall survival, EFS in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1), safety and patient-reported outcomes. The study enrolled 1,174 patients who were randomized 2:1 to receive either:

KEYTRUDA (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by KEYTRUDA plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles as neoadjuvant therapy prior to surgery, followed by nine cycles of KEYTRUDA (every three weeks) as adjuvant therapy post-surgery or;
Placebo (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by placebo plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles as neoadjuvant therapy prior to surgery, followed by nine cycles of placebo (every three weeks) as adjuvant therapy post-surgery.
About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hengrui Acquires PI3k? Inhibitor Rights from Shanghai Lingli Pharma

On February 10, 2021 Jiangsu Hengrui Medicine acquired China rights to a PI3kδ inhibitor (YY-20394) from Shanghai Yingli Pharma (Press release, Jiangsu Hengrui Medicine, FEB 10, 2021, View Source [SID1234575052]). Hengrui will make a $20 million investment in Yingli, and it will be responsible for clinical development of the candidate. PI3kδ inhibitors are expected to be effective treatments for hemotological tumors. Founded in 2011, Yingli Pharma is a small-molecule novel drug R&D company focused on treatments for hematological tumors, solid tumors and kidney-related metabolic diseases. It has an R&D center in Zhangjiang Park.

Onconova Therapeutics, Inc. Announces Pricing of $25 Million Public Offering of Common Stock

On February 10, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the pricing of an underwritten public offering of 25,000,000 shares of its common stock at a public offering price of $1.00 per share (Press release, Onconova, FEB 10, 2021, View Source [SID1234575040]). The gross proceeds of the offering to the Company are expected to be $25.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, Onconova granted the underwriters a thirty-day option to purchase up to an additional 3,750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

The closing of the offering is expected to occur on or about February 16, 2021, subject to the satisfaction of customary closing conditions.

Guggenheim Securities is acting as sole book-running manager. Maxim Group LLC and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above are being offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission (the "SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on February 10, 2021 and is available on the SEC’s website at View Source The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about the Company and the offering. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]

BioVaxys and Procare Health Announce Broad Co-Development, Joint Commercialization and Marketing Collaboration for Cancer and Viral Vaccines

On February 10, 2021 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC:L MNGF) ("BioVaxys"), the world leader in haptenized protein vaccines for antiviral and cancer applications, and Procare Health Iberia, S.L., of Barcelona, Spain ("Procare Health"), a leading privately-held European pharmaceutical company, reported that they have entered into a broad collaboration for the co-development, joint commercialization, and marketing of BioVaxys vaccines for ovarian cancer, cervical cancer, and human papilloma virus ("HPV"), and the right of first refusal for marketing by BioVaxys in the United States of Procare Health’s vaginal gel product, Papilocare, the world’s first and only product to prevent and treat HPV-dependent cervical lesions (Press release, BioVaxys Technology, FEB 10, 2021, https://www.prnewswire.com/news-releases/biovaxys-and-procare-health-announce-broad-co-development-joint-commercialization-and-marketing-collaboration-for-cancer-and-viral-vaccines-301225933.html [SID1234575025]). Left untreated, HPV infection generally leads to cervical cancer (World Health Organization, HPV and Cervical Cancer, 11 November 2020). Formed in 2012 as a spin-out from Procter & Gamble Pharmaceuticals, Procare Health is a market leader in the women’s health field in the European Union ("EU"), with marketed products including Papilocare, Libicare, Palomacare, Idracare, Pronolis HD and Ovosicare.

Under the terms of the agreement, which was executed on February 9th, 2021, the companies will jointly conduct a Phase I Clinical Study of BVX-0918A in Spain, BioVaxys’ autologous haptenized protein vaccine for late-stage ovarian cancer. BioVaxys will be responsible for the core technology and vaccine production, with Procare Health overseeing and making an in-kind investment in the clinical program and regulatory planning, CRO management, patient/clinical center recruitment, marketing, and opinion leader management. Both companies have agreed to equally share costs associated with engaging a European clinical research organization ("CRO") to conduct the study. In return, Procare Health will have exclusive rights to market and distribute BVX-0918A in the European Union ("EU"), and the United Kingdom. Clinical data from the Spanish Phase I study will be used by BioVaxys to support its planned IND for BVX-0918A in the US next year, as well as for all other global markets. The two companies will be working out any remaining details by end of 2Q21.

BioVaxys President and Chief Operating Officer Ken Kovan said "This co-development gives BioVaxys access to Procare Health’s clinical development and regulatory expertise in the EU, and to its marketing & sales presence in Europe." Kovan added that "Procare Health has an established portfolio of marketed brands that is focused heavily on the women’s health and gynecological oncology markets. As we anticipate that these will be the primary users of our ovarian cancer vaccine, the relationship with Procare Health will give access to key gynecological oncology opinion leaders for patient access, clinical trial recruitment, and a relationship that post-approval will drive vaccine sales. Having a strong EU opinion leader network will also be invaluable for our planned US launch of the vaccine."

The collaboration with BioVaxys will help Procare Health fuel its product offerings in the gynecological oncology field. Yann Gaslain, CEO of Procare Health stated, "We are thrilled to start working the collaboration with BioVaxys as it brings a new hope in the field of gynecological cancer. We have been working for 8 years in the area of cervical cancer and HPV, investigating to understand how the immune response of the host could be stimulated to help defend versus HPV infection and persistency, and we believe that the new haptenized cell platform technology can bring a valid answer to this unmet therapeutical need, mainly when high grade lesions of the cervix or even cervical carcinoma have been characterized. The promising vaccine technology platform of BioVaxys will likely help bringing response in ovarian and cervical cancer¨

In Phase I and Phase II clinical studies previously conducted by BioVaxys, co-founder and Chief Medical Officer, Dr. David Berd, using an earlier generation of the BioVaxys cancer vaccine on nearly 500 patients with melanoma or ovarian cancer, the haptenized cell platform showed significant clinical promise. BioVaxys has developed its vaccine technology platforms based on the established immunological concept that modifying proteins with simple chemicals called haptens makes them more visible to the immune system. The process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, thereby stimulating an immune response.

Javier Cortés, MD, Specialist in Gynecology and Cytology for the international Academy of Cytology (Chicago, USA), member of the Spanish association against Cancer (AECC) and of the European Cervical Cancer Association (ECCA) stated, "I believe that the planned clinical trial in Phase I is of a very high interest based on my experience in oncology for more than 30 years. The immunotherapy is a line of treatment with very active investigation and promising early results in some cancers (lungs, melanoma and ovarian). That is why, every single line of investigation well based and with consistent criteria of quality in the design of the investigation should be very well received and encouraged."

Leveraging the recent proven ability of its haptenized viral antigen vaccine platform in stimulating both a 96.4% positive immune response and powerful ‘memory’ T-cell activation against SARS-CoV-2, BioVaxys will use the platform’s flexibility to swap in viral antigens for Human Papilloma Virus ("HPV"), with the intent to develop a treatment for adults who are already infected with HPV. There are vaccines to protect against getting HPV, but none to treat someone who already has HPV. BioVaxys and Procare Health will split costs for feasibility, proof-of-concept, and preclinical development for a HPV viral vaccine, as well as a cervical cancer vaccine based on the BioVaxys cancer vaccine platform. In return, Procare Health will have an exclusive right in the EU and UK for a HPV and/or cervical cancer vaccine, with BioVaxys retaining rights to North America and Rest of World. Development milestones, go/no-go decisions, and other details will be finalized in 2Q2021.

In a major step toward transitioning to a revenue-generating company, BioVaxys has agreed to have a right of first refusal to market and distribute Papilocare in the US.

In Procare Health’s PALOMA Phase IIb clinical trial, Papilocare showed consistent and significant efficacy in normalizing cervical cytology at 3 months and at 6 months in the total study population with 50% to 70% of High-Risk HPV clearance at 6 months in six different international studies and more than 600 patients. HPV infection causes 528,000 cases of cervical cancer and 266,000 cervical cancer deaths each year.1 Papilocare has a CE mark valid for the entire EU, and is currently marketed as a Class IIa medical device in Spain, France, Portugal, Italy, Belgium, Luxembourg, Lithuania, Latvia, Poland, Czech Republic, Hungary, Bulgaria, and Romania. Once the FDA regulatory pathway has been determined for the US, BioVaxys will have a detailed plan in place by 3Q21 to build an appropriate capability to market and support the brand in the US, with BioVaxys providing the funding for such efforts.

James Passin, CEO of BioVaxys, stated, "We are honored to partner with Procare Health, a market leader in gynecological oncology and women’s health in the EU; this transformative collaboration leverages all of the innovative work of Dr. David Berd in the field in oncology and novel vaccine development, as well as our recent success with the preclinical development of a viable haptenized viral protein vaccine for Covid-19. We look forward to using our proprietary haptenized vaccine technology to address urgent and large market deficiencies in the area of women’s health and to potentially generate a new and material revenue stream for our company."

Business Results for the Fiscal Year Ended December 31, 2020(Unaudited)

On February 10, 2021 Kuraray Co., Ltd. reported that Business Results for the Fiscal Year Ended December 31, 2020 (Unaudited) (Press release, Kuraray, FEB 10, 2021, https://pdf.irpocket.com/C3405/HTFv/kDuX/RKtl.pdf [SID1234575002]).

1. Consolidated Financial Results for Fiscal 2020 (January 1, 2020 to December 31, 2020)
(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

(2) Consolidated Financial Position
(3) Consolidated Cash Flows

2. Dividends

3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2021 (January 1, 2021 to December 31, 2021) (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

1. Unconsolidated Results for Fiscal 2020 (January 1, 2020 – December 31, 2020) (Percentages displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the previous fiscal year.)

(1) Unconsolidated Operating Results
(2) Unconsolidated Financial Position

1. Qualitative Information regarding Business Results
(1) Overview of Consolidated Business Results In the fiscal year ended December 31, 2020 ("fiscal 2020"), the global economy rapidly declined due to the worldwide spread of COVID-19 at the beginning of the year as the prolonged trade war between the United States and China and emerging geopolitical risks around the globe caused global trade to shrink. Amid this environment, to support industrial supply chains, the Group maintained business activities after ensuring safety and taking thorough measures to prevent the spread of infection.

The Group’s long-term vision, Kuraray Vision 2026, is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies." With the aim of realizing this vision, we will steadily take specific measures in line with the key management strategies underlined in the medium-term management plan "PROUD 2020." Through these efforts, we will also continue working to establish a new business portfolio from a medium-to long-term perspective. In fiscal 2020, demand for products used for electric, electronic, and food packaging applications remained steady even during the pandemic. However, demand for products for automotive and construction applications plunged, and, despite gradually recovering from the second half of the fiscal year, demand for the full year was much lower than in the previous year.

Consequently, consolidated operating results for fiscal 2020 are as follows: net sales decreased ¥34,009 million, or 5.9%, compared with the previous fiscal year to ¥541,797 million; operating income fell ¥9,831 million, or 18.1%, to ¥44,341 million; ordinary income decreased ¥8,530 million, or 17.7%, to ¥39,740 million; and net income attributable to owners of the parent totaled ¥2,570 million (compared with net loss attributable to owners of the parent of ¥1,956 million in the previous fiscal year). In fiscal 2020, Kuraray recognized a loss on litigation of ¥23,196 million which has been classified as an extraordinary loss mainly in connection with a fire in May 2018 at a group subsidiary in the United States. Results by Business Segment Vinyl Acetate Sales in this segment decreased 3.4% year on year to ¥257,114 million, and segment income fell 13.9% year on year to ¥40,779 million.

(1) Sales of PVA resin remained weak due to stagnant global demand and a subsequent production adjustment. Due to a recovery in demand, especially for large displays, the sales volume of optical-use poval film increased. Demand for PVB film gradually recovered from the third quarter onward despite the effects of stagnant demand for construction and automotive applications. However, sales of water-soluble PVA film expanded for use in unit dose detergent packets.
(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased for food packaging applications due to at-home consumption but gas tank applications remained weak. Isoprene Sales in this segment decreased 5.4% year on year to ¥50,390 million, and segment income fell 10.0% year on year to ¥3,808 million.

(1) Sales of isoprene chemicals and SEPTON thermoplastic elastomer began to recover from the fourth quarter despite being affected by stagnant demand, mainly in China and the rest of Asia.
(2) Sales of GENESTAR heat-resistant polyamide resin remained brisk for electric and electronic device applicationsFunctional Materials Sales in this segment decreased 0.8% year on year to ¥124,980 million, and segment income fell 21.9% year on year to ¥2,994 million.

(1) The overall methacrylate business was affected by rising raw material costs and worsening market conditions despite an increase in sales of spatter-blocking barrier panels and displays.
(2) In the medical business, the dental materials business struggled mainly in Europe and the United States in the first half of the year due to clinic closings caused by the pandemic and sales decreased.
(3) As for Calgon Carbon and the Carbon Materials business, sales were steady, especially of products for water treatment applications, even during the pandemic as such products underpin people’s daily lives.

Furthermore, in line with expanding demand for high-performance activated carbon, we decided to expand facilities at Calgon Carbon Corporation’s existing U.S. factory in the second quarter. In addition, with expanding demand for industrial applications, we decided in the third quarter to expand the facilities for reactivated carbon at our Belgian subsidiary. Fibers and Textiles Sales in this segment fell 15.7% year on year to ¥54,408 million while segment income decreased 61.9% year on year to ¥2,155 million.

(1) The sales volume of CLARINO man-made leather decreased due to receding demand, especially for shoe applications in Asia and luxury good applications in Europe.
(2) In fibers and industrial materials, the sales volume of KURALON decreased for cement reinforcement and rubber materials.
(3) In consumer goods and materials, the sales volume of KURAFLEX decreased as sales for automotive and cosmetic applications stagnated despite an increase in sales volume for mask-related applications. Trading In fiber-related businesses, despite firm sales for sports clothing, sales remained weak for materials and products for other applications due to a polyester fiber production adjustment as well as stagnant demand. However, demand for resins and chemicals recovered in China in the second half of the fiscal year and performance was on par with the previous year.

As a result, segment sales decreased 4.9% year on year to ¥124,438 million, and segment income fell 14.6% to ¥3,606 million.Others In other business, due to weak sales of domestic affiliates, segment sales declined 18.4% year on year to ¥41,707 million, and segment income fell 67.0% to ¥214 million.

(2) Overview of Financial Position We increased liquidity to prepare for funding aimed at securing resilience against financial risks caused by the COVID-19 pandemic. Specifically, liquidity comprising cash and cash deposits and investment securities increased ¥86,888 million due mainly to an increase of ¥104,524 million in interest-bearing debt, including increases of ¥30,000 million in corporate bonds and ¥78,875 million in long-term loans payable. Due primarily to the above factors, total assets increased ¥60,435 million from the end of the previous fiscal year to ¥1,051,584 million. Total liabilities increased ¥83,499 million from the end of the previous fiscal year to ¥536,103 million due mainly to the aforementioned increase in interest-bearing debt and a decrease of ¥32,534 million in accrued expenses. Total net assets fell ¥23,064 million to ¥515,481 million. Equity attributable to owners of the parent amounted to ¥498,798 million, for an equity ratio of 47.4%.

(3) Overview of Cash Flows Cash Flows from Operating Activities: Net cash provided by operating activities totaled ¥79,947 million. Cash provided included ¥9,127 million from income before income taxes and noncontrolling interests. Cash used included ¥62,459 million in depreciation and amortization, a ¥16,731 million decrease in inventories, ¥9,624 million in income taxes paid, and ¥37,543 million from loss on litigation paid.Cash Flows from Investing Activities: Net cash used in investing activities totaled ¥64,025 million. Contributing factors included a ¥14,625 million decrease in investment securities and ¥83,490 million used for the purchase of tangible fixed assets and intangible fixed assets.

Cash Flows from Financing Activities: Net cash provided by financing activities was ¥91,508 million. Cash provided included ¥79,274 million in proceeds from long-term loans payable and ¥30,000 million from corporate bonds. Cash used included a ¥4,000 million decrease in commercial paper and cash dividends paid totaling ¥14,784 million. The above factors along with the effect of exchange rate changes on cash and cash equivalents resulted in a ¥106,116 million increase in cash and cash equivalents at the end of the fiscal year to ¥182,084 million.

(4) Outlook for Fiscal 2021 In the next year, the global economy is expected to gradually head toward recovery as countries around the world grapple with stopping the spread of COVID-19 and maintaining economic activity. Although the recovery situation is expected to differ for each region and industry, a full recovery is forecast for the second half of the fiscal year onward. At the same time, it is difficult to predict the impact of a shift in U.S. government policies under the newly elected president on trade with China and the actual economy.

Accordingly, the uncertain outlook is expected to continue into the next fiscal year as well. Based on these circumstances, the forecast of operating results for fiscal 2021 is as shown below. Furthermore, although we recorded an extraordinary loss in fiscal 2020 related to the litigation over the fire at the U.S. subsidiary, the litigation is still ongoing.

(5) Basic Policies Related to Profit Distribution and Dividends in Fiscal 2020 and 2021 The Company positions the distribution of profits to all shareholders as a priority management issue. Our basic policy is to increase profit distribution through the sustainable improvement of operating results. During "PROUD 2020" (fiscal 2018–2020), our basic policy was to ensure a total return ratio of at least 35% as a proportion of net income attributable to owners of the parent and an annual dividend per share of ¥40. Under this policy, the interim dividend in fiscal 2020 was ¥21 per share, and the year-end dividend is expected to amount ¥19, for a total annual dividend of ¥40 per share.

In fiscal 2021, continuing with the policy for the "PROUD 2020" period, our basic policy is to ensure a total return ratio of at least 35% as a proportion of net income attributable to owners of the parent, and an annual dividend of at least ¥40 per share. We therefore plan to pay out an annual dividend of ¥40 (dividend payout ratio: 45.86%) comprising an interim dividend of ¥20 and a year-end dividend of ¥20, having set a prerequisite of recording ¥30.0 billion in net income attributable to owners of the parent.

2. Management Policies
(1) Fundamental Management Policies Kuraray’s mission is: "For people and the planet—to achieve what no one else can." Based on this, the Company has established the Kuraray Vision 2026 long-term vision, which we aim to realize by 2026, the centennial of the Company’s founding. The vision for Kuraray is of being a: "Specialty Chemical Company growing sustainably by incorporating new foundational platforms into its own technologies." Kuraray will remain a company that provides the world with unmatched specialty products and services while creating value with society.

(2) Management Indicator Targets, Medium-to Long-Term Strategies and Issues to Be Addressed In line with Kuraray Vision 2026, the Group established the three basic policies listed below. 1) Pursue competitive superiority Kuraray will continue to enhance its competitiveness by developing high-value-added products and applications based on customer needs, strategically reinforcing initiatives with the understanding that burgeoning emerging countries offer new opportunities, and achieving innovation and improvement of production and operational processes through the use of IoT.
2) Expand new business fields We will expand new business fields through the creation of new businesses by improving on Kuraray’s own technologies and incorporating external ones, the capture of new business areas by M&A and alliance, and the establishment of a new business model bundling technology and services.

3) Enhance comprehensive strength of the Kuraray Group Kuraray will establish global business foundations in line with its expanding businesses, create a workplace in which employees find their jobs rewarding to attract high-quality, diverse talent from around the world, and cultivate a strong culture of unity within the Kuraray Group while reinforcing measures to ensure thorough compliance. Through the implementation of the basic policies listed above, the Company will further strengthen its core segment of vinyl acetate-related business, establish second and third pillars of business, and create new future-oriented businesses with the aim of building a new portfolio for sustainable growth. During the period of the medium-term management plan "PROUD 2020,

" we acquired Calgon Carbon Corporation, which is the largest activated carbon producer in the world, and decided to expand activated carbon facilities in the United States with the aim of further expanding business. We also decided to invest in the construction of a new isoprene plant in Thailand. In addition, we have strengthened initiatives aimed at building a forward-looking, stable business portfolio by steadily implementing targeted strategic measures to achieve growth, including expanding facilities for optical-use and water-soluble PVA films.

In 2020, which is the last fiscal year of the plan, demand in many industries fell sharply due to stagnant economic activity around the world caused by the COVID-19 pandemic. Although demand began to recover from the third quarter, especially in China and the United States, full-year operating results have turned out to be lower than the annual plan. Considering that the effects of the pandemic are still unclear, the next medium-term management plan will span five years, from 2022 to 2026—the 100th anniversary of Kuraray’s founding, and 2021 will be covered by a single-year management plan.

In 2021, we will move steadily ahead with the construction of the new isoprene plant in Thailand, an investment decision made under "PROUD 2020," and accelerate the generation of integrated synergies with Calgon Carbon in the environmental solutions business (activated carbon business) as well as further expanding our vinyl acetate-related businesses. In addition, we will promote our group-wide digital strategy, make it possible to reform operational processes and swiftly build business strategies, and focus on developing digitally proficient personnel. In this way, we will strengthen our competitive position while looking to ensure the continuity of these efforts and the next medium-term management plan slated to start in 2022.

In addition, there was a fire that resulted in injuries of outside contract workers at a U.S. subsidiary in May 2018, and a civil lawsuit was filed seeking damages. Although we have reached a settlement with some of the plaintiffs, the litigation continues. To ensure a similar fire does not occur again, safety inspections have been conducted at our main overseas chemical plants since 2019 under the guidance of the Kuraray headquarters in an effort to revise and strengthen safety measures. In 2020, we conducted safety inspection at two plants in Europe and two plants in the United States. We confirmed the status of improvement on issues identified in 2019 and identified new issues. Going forward, we will address the newly identified issues while continue diligently working to enhance the safety of our equipment atplants, revise and improve management systems and manuals, enhance employee education, and take other such measures.

3. Basic Approach to Selection of Accounting Standards The Kuraray Group applies Japanese generally accepted accounting principles ("GAAP"). The Kuraray Group is considering the adoption of International Financial Reporting Standards ("IFRS") and other matters while taking into account various circumstances in Japan and overseas

.(5) Notes regarding Consolidated Financial Statements Notes regarding Going Concern Assumptions None Changes to Presentation Methods (Regarding Consolidated Cash Flow Statements) "Insurance received" and "insurance income," which had been listed separately under net cash provided by (used in) operating activities in the previous consolidated fiscal year, were included in the "Other, net" line item in fiscal 2020 because their financial significance had diminished. To reflect this change in presentation methods, we revised the consolidated financial statements of the previous fiscal year. As a result, in the consolidated cash flow statement of the previous fiscal year, the −¥11,374 million presented for insurance received and the ¥11,374 million presented for insurance income under net cash provided by (used in) operating activities were reclassified as "Other, net." Changes to Accounting Estimates

●Loss on litigation Regarding the fire that occurred in May 2018 at the Company’s U.S. subsidiary, in the previous fiscal year Kuraray recorded an estimate of part of the damages sought through litigation brought against several companies, including said U.S. subsidiary. However, due to subsequent progress made in the litigation and settlement negotiations, we were able to make a more rational estimate of the loss. We therefore revised our estimate, and the difference between the original and new estimates is listed under extraordinary loss. As a result, fiscal 2020 income before income taxes and noncontrolling interests decreased ¥5,212 million.

Segment and Other Information (Segment Information) 1. Segment Overview The business segments reported by Kuraray are the business units for which the Company is able to obtain respective financial information separately in order for the Board of Directors to conduct periodic investigations to determine the distribution of management resources and evaluate their business results. Kuraray adopts an in-house company system where each in-house company conducts business activities and establishes its own comprehensive strategy, both for Japan and for overseas markets, for the products it handles. In addition, among Kuraray subsidiaries, Kuraray Trading Co., Ltd. independently conducts propriety planning and sales activities, including the processing and sale of Kuraray Group products as well as other companies’ products. Consequently, Kuraray has created five business segments for reporting – "Vinyl Acetate," "Isoprene,""Functional Materials," "Fibers and Textiles" and "Trading" – categorized by product group based on the respective in-house companies and the Trading segment. The Vinyl Acetate segment manufactures and markets functional resins and film, including PVA, PVB and EVAL. The Isoprene segment manufactures and markets SEPTON thermoplastic elastomer, isoprene-related products and GENESTAR.

The Functional Materials segment manufactures and markets methacrylic resin, medical products and carbon materials. The Fibers and Textiles segment manufactures and sells synthetic fibers and textiles, CLARINO man-made leather, non-woven fabrics and others. The Trading segment mainly processes and sells synthetic fibers and man-made leather, and conducts planning and marketing for other products produced by the Kuraray Group and other companies. 2. Methods for Calculating Reporting Segment Net Sales, Income and Loss, Assets and Other Items The accounting method applied to reported business segments is the same as that used in creating the consolidated financial statements. Profits from reported segments are operating income, and intersegment sales and transfers are based on the prevailing market prices