On February 4, 2020 Nippon Kayaku reported Financial Results For the Third Quarter of the Fiscal Year Ending March 31, 2020 (Press release, Nippon Kayaku, FEB 4, 2020, View Source net/doc/4272/ir_material_for_fiscal_ym8/76321/00.pdf [SID1234553800]).

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1. Consolidated Business Results for the First Three Quarters of the Fiscal Year Ending March 31, 2020 (April 1, 2019–December 31, 2019)

(1) Significant changes in subsidiaries during the first three quarters (changes in designated subsidiaries that result in changes in scope of consolidation): None

(2) Adoption of special accounting methods for presenting the quarterly consolidated financial statements: None

(3) Changes to accounting policies and estimates and restatements

[1] Changes to accounting policies associated with revision of accounting standards or similar items: None
[2] Changes other than
[1]: None
[3] Changes to accounting estimates: None
[4] Restatements: None (4) Number of shares issued (common stock)

[1] Number of shares issued at end of the fiscal period (including treasury stock) As of December 31, 2019: 177,503,570 shares As of March 31, 2019: 182,503,570 shares
[2] Number of treasury stock at end of the fiscal period As of December 31, 2019: 5,275,358 shares As of March 31, 2019: 9,358,749 shares
[3] Average number of shares during the fiscal period (cumulative) First three quarters of fiscal year ending March 31, 2020: 173,012,317 shares First three quarters of fiscal year ended March 31, 2019: 173,145,466 shares *Quarterly summary financial statements are not subject to audit by a certified public accountant or audit firm. *Analysis related to appropriate use of the business results forecasts, and other notes The information in this report constitutes forward-looking statements regarding future events and performance.

This information is based on the beliefs and assumptions of management in light of information currently available to it at the time of announcement and subject to a number of uncertainties that may affect future results. Actual business results may differ substantially from the forecasts herein due to various factors.

For matters pertaining to business forecasts, please refer to "(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts" on page 3 of the Supplementary Information

1. Qualitative Information Concerning Results for the First Three Quarters

(1) Analysis of Operating Results In the first three quarters of this consolidated fiscal year (April 1, 2019 to December 31, 2019), the global economy as a whole saw continued slow growth. This was mainly due to the deceleration of external demand in the manufacturing industry, while consumer spending remained steady on the back of an improved employment and income environment in the U.S. and Europe. The trend of deceleration in economic growth persisted in China, owing to the impact from trade friction between the U.S. and China, among other factors. The Japanese economy showed signs of a gradual rebound despite weak exports. This resulted mainly from moderate growth in capital investment and a resurgence in consumer spending. Amid these conditions, the Nippon Kayaku Group worked to implement the key themes and resolve the midand long-term key issues outlined in "KAYAKU Next Stage," the mid-term business plan launched this fiscal year.

We worked to cut costs further to reinforce our profit structure, in addition to focusing on strengthening R&D, optimal allocation of business resources into core businesses, and expanding our overseas business. Owing to these actions, net sales for the first three quarters of this consolidated fiscal year outperformed the same period of the previous fiscal year in the functional chemicals business, the pharmaceuticals business, and the safety systems business, resulting in total net sales of 131,825 million yen, an increase of 2,924 million yen (2.3%) yearon-year. Operating income totaled 14,231 million yen, a decrease of 331 million yen (2.3%) year-on-year. Ordinary income totaled 14,682 million yen, a decrease of 1,307 million yen (8.2%) year-on-year due to an increase in exchange losses. Profit attributable to owners of parent was 11,302 million yen, an increase of 721 million yen (6.8%) year-onyear due to a decrease in income taxes-deferred. Performance by business segment is as described below. [Functional Chemicals Business] Sales stood at 53,260 million yen, an increase of 1,892 million yen (3.7%) year-on-year. The functional materials business recorded growth in sales over the same period of the previous fiscal year. This growth was resulted from strong sales of epoxy resins for 5G base stations, which more than covered for the deceleration in demand from the semiconductor market. The color materials business outperformed the same period of the previous fiscal year, boosted by strong sales of colorants for inkjet printers for industrial applications and materials for thermal paper, despite the negative impact from deceleration of the Chinese market. The catalyst business outperformed the same period of the previous fiscal year. In the Polatechno Group, sales of components for X-ray analysis systems were strong, but sluggish sales of dyetype polarizing films resulted in underperformance of the Polatechno Group as a whole, compared with the same period of the previous fiscal year. Segment profit was 4,537 million yen, a decrease of 1,011 million yen (18.2%) year-on-year. [Pharmaceuticals Business] Sales stood at 36,327 million yen, an increase of 831 million yen (2.3%) year-on-year. Pharmaceuticals in Japan were impacted by drug price revisions accompanying the increase in the consumption tax rate, but the segment outperformed the same period of the previous fiscal year as growth in sales for the antibody biosimilar, INFLIXIMAB BS for I.V. Infusion, and for TRASTUZUMAB BS for I.V. Infusion contributed to performance along with growth in generic anti-cancer drugs as the switch to generic drugs continued. Although exports and diagnostic agents underperformed the same period of the previous fiscal year, sales of active pharmaceutical ingredients and contract production for the Japanese domestic market outperformed the same period of the previous fiscal year. Segment profit totaled 3,947 million yen, an increase of 991 million yen (33.5%) year-on-year. [Safety Systems Business] Sales stood at 36,182 million yen, an increase of 797 million yen (2.3%) year-on-year. Business in Japan outperformed the same period of the previous fiscal year due to firm sales of both airbag inflators and micro gas generators for seatbelt pretensioners. The overseas business overall saw sales decline from the same period of the previous year as the deceleration of Chinese market growth caused sales of air bag inflators and squibs to underperform year-on-year. While sales of micro gas generators for seatbelt pretensioners outperformed the same period of the previous fiscal year due to the increase in the automotive safety component installation rate, this did not compensate for the above decline. Nippon Kayaku Co., Ltd.

Summary of Consolidated Financial Results [Japanese GAAP] For the Third Quarter of the Fiscal Year Ending March 31, 2020

I. First three quarters of the fiscal year ended March 31, 2019 (April 1, 2018– December 31, 2018)

2. Information concerning impairment losses on non-current assets, goodwill, etc. by reportable segment (Material change in the amount of goodwill) The business combination with RaySpec Limited which was implemented on December 26, 2017, was subject to provisional accounting in fiscal year ended March 31, 2018 and confirmed during the previous consolidated fiscal year. This has resulted in a decrease in the amount of goodwill in the functional chemicals business segment. (Business Combinations, etc.) (Regarding the Acquisition of Shares via Tender Offer and the Demand for the Sale of Shares) Nippon Kayaku decided to acquire the consolidated subsidiary POLATECHNO CO., LTD. (hereafter, "Polatechno") via tender offer (hereafter, "this tender offer"), based on the Financial Instruments & Exchange Act. The resolution was approved at the Board of Directors meeting held on August 27, 2019.

This tender offer was executed and the acquisition was completed on October 10, 2019. A Demand for the Sale of Shares was subsequently exercised based on Article 179, Paragraph 1 of the Companies Act, and Nippon Kayaku made Polatechno a wholly owned subsidiary on November 12, 2019.

1. Summary of Business Combination (1) Name and business description of the business to be combined Name of company: POLATECHNO CO., LTD. Business description: Manufacture and sale of components for LCD displays, components for LCD projectors, etc.

(2) Dates of business combination Acquisition via tender offer: October 18, 2019 (deemed acquisition date: October 1, 2019) Acquisition via the Demand for the Sale of Shares: November 12, 2019 (deemed acquisition date: October 1, 2019)

(3) Legal form of business combination Acquisition of shares for cash

(4) Name of company after combination No change.

(5) Percentage of subsidiary shares held after additional acquisition: Percentage of shares held prior to business combination: 66.45% Percentage of shares held after tender offer: 99.20% Percentage of shares held after the Demand for the Sale of Shares: 100.00% 2.

Breakdown of the cost of acquiring additional shares of the subsidiary and type of payment (including the shares Nippon Kayaku intends to acquire via the Demand for the Sale of Shares) Acquisition for cash: 13,808 million yen Acquisition cost: 13,808 million yen 3.

Overview of Accounting Method Implemented These transactions qualify as transactions under common control specified in the Revised Accounting Standard for Business Combinations (ASBJ Statement No.21, September 13, 2013) and Revised Guidance on Accounting Standard for Business Combinations and Accounting Standard for Business Divestitures (ASBJ Guidance No.10, September 13, 2013) and Nippon Kayaku is handling these as transactions under common control.

On February 4, 2020 PharmaCyte Biotech (OTCQB: PMCB) is reported to embark upon a planned U.S. FDA Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC) at trial sites all over the United States, and with that journey comes the need to keep its signature technology, Cell-in-a-Box, protected should it one day receive marketing approval from drug regulatory agencies in the U.S. and Europe (Press release, PharmaCyte Biotech, FEB 4, 2020, View Source [SID1234553841]). PharmaCyte’s Cell-in-a-Box technology for the treatment of pancreatic cancer is certainly protected well into the future if/when it does receive the coveted marketing approval it’s striving for upon the completion of clinical trials.

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Currently, PharmaCyte is revamping its provisional patent application and its strategy related to full patent protection. The idea is to present the United States Patent and Trademark Office (USPTO) with an acceptable provisional patent application that protects its therapy to treat cancerous tumors, including the therapy that will be used in its upcoming clinical trial in LAPC.

Provisional patent applications are a way to establish and protect a "date of invention" or "priority filing date" for one year. The provisional patent application was created to provide inventors with a way to begin protecting their inventions, and an approved provisional patent application will provide PharmaCyte 12 months to prepare a full patent application. This approach will offer the company an opportunity to establish an early effective filing date for a patent.

A provisional patent—and eventually a full patent—would give PharmaCyte a fresh 20 years of patent protection; however, even without it, PharmaCyte has protections in place to protect its technology that are in line with any biotechnology/pharmaceutical company developing treatments after many years. In most cases, the 20-year patent protection that biotechnology/pharmaceutical companies have in place while developing drugs/treatments, have their 20-year time frame cut in half to 10 years by the time the drug hits the marketplace.

Patents are typically awarded within a few years after the patent application submission, but a common misconception is that the patent begins only after the drug hits the market, so with this in mind, PharmaCyte will actually have longer protections in place than most biotechnology/pharmaceutical companies have upon marketing approval after years of development.

How is this possible? Well, actually PharmaCyte has two protections in place that will keep its technology protected—and unlike 20-year patent protection where the clock is ticking throughout development, these protections don’t begin until the therapy is approved. First, PharmaCyte is developing a "biologic" therapy, which offers protections under the Affordable Care Act, and second, PharmaCyte’s therapy for pancreatic cancer was granted Orphan Drug Designation from both the U.S. FDA and in the European Union by the European Medicines Agency (EMA).

PharmaCyte’s pancreatic cancer therapy was designated an orphan drug and listed in the official registry of medicinal products for rare diseases by the U.S. FDA on December 17, 2014. This orphan drug status assures marketing exclusivity for PharmaCyte’s pancreatic cancer therapy in the U.S. for 7 years after market approval by the FDA. Also, PharmaCyte has orphan drug status in the European Union (EU) for its pancreatic cancer therapy. This designation provides 10 years of marketing exclusivity in all countries in the EU following approval by the European Medicines Agency (EMA).

In addition, the Biologics Price Competition and Innovation Act (BPCIA), which was enacted as part of the Affordable Care Act in 2010, establishes a period of 12 years of "data exclusivity" for reference products to preserve incentives for future innovation. Under this framework, data exclusivity protects the data in the innovator’s regulatory application by prohibiting others, for a period of 12 years, from gaining FDA approval based in part on reliance on or reference to the innovator’s data in a biosimilar application. PharmaCyte’s 12-year exclusivity doesn’t begin until the FDA approves the company’s pancreatic cancer therapy.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the protections for the company’s pancreatic cancer therapy, "If our pancreatic cancer therapy receives FDA approval, the orphan drug designation in the U.S. and the EU, together with the BPCIA data exclusivity, will give us substantial marketing exclusivity for our pancreatic cancer therapy. Any new patent application, while it does include our pancreatic cancer therapy, should really be viewed as an opportunity to dramatically broaden PharmaCyte’s ability to protect our therapy for all malignant tumors for the next 20 years."

On February 4, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that President and CEO Michael W. Nall will present a corporate overview at the 22nd Annual BIO CEO & Investor Conference on Monday, February 10, 2020, at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) (Press release, Biocept, FEB 4, 2020, View Source;investor-conference-300998277.html [SID1234553857]). The conference is being held at the New York Marriott Marquis in New York City.

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A live webcast of the conference presentation will be available on the Company’s website at ir.biocept.com. A replay of the webcast will be available for 90 days.

About BIO CEO & Investor Conference

The BIO CEO and Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies. The event features issue-oriented plenary sessions, educational sessions focused on hot therapeutic areas and key business issues, company presentations, one-on-one meetings, and networking opportunities.

On February 4, 2020 The lOR Institute of Oncology Research reported Antibody-drug conjugates (ADCs) are an effective therapeutic modality to deliver potent cytotoxic molecules to tumor cells bearing a specific antigen (Press release, The lOR Institute of Oncology Research, FEB 4, 2020, View Source [SID1234553826]). Following their previous work on the anti-CD19 ADCs huB4-DGN462 and coltuximab ravtansine (SAR3419) (PMID 30733273), the research team led by Prof. Francesco Bertoni has now characterized the novel ADC MEN1309/OBT076 targeting CD205 for its anti- lymphoma activity.

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The work done by Dr Eugenio Gaudio, Dr Chiara Tarantelli and Colleagues, now published in the journal Haematologica, have provided the rationale to explore the compound in patients with relapsed or refractory CD205-positive lymphoma in the on-going phase I study (NCT03403725).

Targeting CD205 with the antibody drug conjugate MEN1309/OBT076 is an active new therapeutic strategy in lymphoma models

by Eugenio Gaudio*, Chiara Tarantelli*, Filippo Spriano, Francesca Guidetti, Giulio Sartori, Roberta Bordone, Alberto J. Arribas, Luciano Cascione, Mario Bigioni, Giuseppe Merlino, Alessio Fiascarelli, Alessandro Bressan, Afua Adjeiwaa Mensah, Gaetanina Golino, Renzo Lucchini, Elena Bernasconi, Davide Rossi, Emanuele Zucca, Georg Stussi, Anastasios Stathis, Robert S. Boyd, Rachel L. Dusek, Arnima Bisht, Nickolas Attanasio, Christian Rohlff, Andrea Pellacani, Monica Binaschi, and Francesco Bertoni

On February 4, 2020 Takeda Pharmaceutical Company Limited reported the (Press release, Takeda, FEB 4, 2020, View Source [SID1234553842]).

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Underlying Revenue declined -1.2% vs FY2018 Q3 YTD pro-forma2, expected to recover in Q4 resulting in flat to slightly increasing for the full year

Takeda’s 14 global brands, with reported revenue of 836.4 billion yen in aggregate, posted a strong year- over-year underlying revenue growth of +20%, driven by ENTYVIO (+35.4%), TAKHZYRO (+622.2%), and NINLARO (+28.9%).
Underlying revenue growth year-to-date was solid in the key business areas of GI (+10%), Plasma Derived Therapy (PDT) Immunology (+5%), Oncology (+7%), and Neuroscience (+5%), while Rare Diseases declined (-11%) for the following reasons:
Rare Hematology (-14%) continues to be impacted as expected by intensified competition and increasing price pressure.
Hereditary Angioedema (HAE) (-11%) continues to be negatively affected by stocking in the prior fiscal year, as well as generic entry for FIRAZYR.
Rare Metabolic (-4%) continue to be impacted by NATPARA which was recalled in the U.S. in September 2019.
Please refer to note iii to the table entitled "Reported Results for FY2019 Q3 YTD (April – December)" below for Core Operating Profit definition.
FY2018 Q3 YTD pro-forma baseline represents the sum of Takeda revenue for FY2018 Q3 YTD (Apr-Dec) plus Shire revenue for the same period, where Shire revenue was converted to JPY at the rate of $1 = 111 JPY (average FX rate for FY2018) and converted from US GAAP to IFRS with no material difference; Takeda revenue and Shire revenue was adjusted to remove the revenue from divested assets. Please see the appendix for more details.

Underlying Core Operating Profit Margin of 30.9% for FY2019 Q3 YTD driven by cost synergies and OPEX efficiencies

Reported Operating Profit declined year-over-year -42.9% to 162.5 billion yen, largely impacted by non-cash purchase accounting expenses including the unwinding of inventory step-up and amortization of intangible assets. Reported Operating Profit was also impacted by significant one-time costs related to the Shire integration.
Core Operating Profit increased year-over-year +129.9% to 792.2 billion yen, primarily due to the consolidation of Shire, while also benefitting from the strong performance of Takeda 14 global brands, cost synergies and improved OPEX efficiency.
Underlying Core Operating Profit Margin year-to-date was 30.9% reflecting continued OPEX discipline and cost synergies.
Underlying Core EPS year-to-date was 359 yen.
R&D Engine Delivered Several Important Pipeline Milestones in Q3

Wave 1 pipeline assets achieving important milestones:
Phase 3 study start for TAK-788 in treatment naïve Non-Small-Cell Lung Cancer (NSCLC) with exon 20 insertion mutations, and pevonedistat (TAK-924) in unfit Acute Myeloid Leukemia.
Updated Dengue vaccine candidate TAK-003 results from the phase 3 study were presented at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting.
Announced partnership with MD Anderson Cancer Center which includes the development of ongoing Phase 1/2a Study of TAK-007, a CD19 CAR-NK.
Global Brands generating additional data in new indications:
Phase 3 trial of NINLARO (TOURMALINE-MM4) as first line maintenance therapy met primary endpoint (PFS) in multiple myeloma patients not treated with stem cell transplantation.
ALUNBRIG ongoing phase 3 data continued to show reduction in disease progression after two years as a first line treatment in adults with advanced anaplastic lymphoma kinase-positive (ALK+) NSCLC who had not received a prior ALK inhibitor.
Continued emphasis on divesting non-core assets and deleveraging to focus the business

Net debt / adjusted EBITDA at 4.1x having paid full-year dividend and tax on XIIDRA proceeds.
Negotiations ongoing for further potential non-core asset divestments.

Costa Saroukos, Chief Financial Officer, commented:
"Takeda’s third quarter results demonstrated a continuation of our solid year-to-date financial and business performance, driven by our 14 global brands, powerful R&D engine, and OPEX improvements that will help to ensure our sustainable growth. We are again increasing our full year guidance to reflect strong business momentum and faster than anticipated realization of synergies.

Now operating as One Takeda, we continue to execute as anticipated on our business priorities to drive long-term value, including the realization of $2 billion in cost synergies by the end of FY 2021, divest $10 billion in non-core assets to optimize our portfolio, and rapidly de-leverage our net debt / adjusted EBITDA towards our goal of 2x within fiscal years ending March 2022 – March 2024. In parallel, our R&D engine continues to advance highly innovative medicines that make a critical difference to patients through both Takeda’s global brands and new molecular entities, with multiple important data readouts on the horizon. Executing on these priorities will maximize value creation for all of our stakeholders and position Takeda for continued success."

Reported Results for FY2019 Q3 YTD (April – December)

Underlying results compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.
Growth versus FY2018 Q3 YTD pro-forma. FY2018 Q3 YTD pro-forma baseline represents the sum of Takeda revenue for FY2018 Q3 YTD (Apr-Dec) plus Shire revenue for the same period, both adjusted to remove the revenue from divested assets, converted to JPY at the rate of $1 = 111 JPY (average FX rate for FY2018), and converted from US GAAP to IFRS with no material differences. Please see the appendix for more details.
Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as purchase accounting effects and transaction related costs.
Attributable to the owners of the company.
FY2019 Management Guidance: Upgrading guidance to reflect positive business momentum

Constant Exchange Rate growth (applying FY2018 full year average foreign exchange rate of 111 JPY/USD) compared to baseline of JPY 3,300 billion (Rounded pro-forma April 2018-March 2019 combined revenue of Legacy Takeda and Legacy Shire, converted at April 2018-March 2019 average exchange rate of 111 JPY/USD; also adjusted to remove the revenue from divested assets such as Techpool, Multilab, and TACHOSIL from Legacy Takeda, and the oncology portfolio and XIIDRA from Legacy Shire) and converted from US GAAP to IFRS, without material differences.