Thursday, July 27, 2023

Takeda Reports Strong First Quarter FY2023 Results, Driven by Growth & Launch Products

 OSAKA, Japan & CAMBRIDGE, Mass. - Thursday, 27. July 2023





No Change to Full-Year Forecasts or Management Guidance

Revenue Growth of +8.9% at Actual Exchange Rate (AER); +3.7% Growth at Constant Exchange Rate (CER), Driven by Growth & Launch Products (+16.2% at CER)

Reported Operating Profit Growth of +12.0% at AER; Core Operating Profit Decline of -2.0% at CER Reflecting Generic Impact, Lower Demand for Coronavirus Vaccines and Increased Investment in R&D and Data & Technology

Core Operating Profit Margin of 30.8%

Anticipated Pipeline Advances with 8 Key Regulatory Decisions Expected by End of FY2023, Furthering Commitment to Delivering Life-transforming Medicines to Patients

 


(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) today announced strong financial results for the first quarter of fiscal year 2023 (period ended June 30, 2023).


Takeda chief financial officer, Costa Saroukos, commented:

“Our Growth & Launch Products continued to drive revenue growth in the first quarter of FY2023, contributing to a core operating profit margin of 30.8%. While we still anticipate headwinds affecting our business this fiscal year, largely due to generic competition, we remain confident of a return to growth in the near-term.


“Our growing product portfolio and innovative pipeline demonstrate the value of our strategic investments to strengthen our long-term competitiveness and enable our vision of discovering and delivering life-transforming treatments.”


FINANCIAL HIGHLIGHTS


Results for FY2023 Q1 Ended June 30, 2023


(Billion yen,

except

percentages and

per share amounts)


REPORTED


CORE(c)


(Non-IFRS)(a)


FY2023 Q1


vs. PRIOR YEAR


(AER % change(d))


FY2023 Q1


vs. PRIOR YEAR


(AER % change(d))


vs. PRIOR YEAR


(CER % change(d))


Revenue


1,058.6


+8.9%


1,058.6


+8.9%


+3.7%


Operating Profit


168.6


+12.0%


326.3


+2.3%


-2.0%


Margin


15.9%


+0.4pp


30.8%


-2.0pp


 


 


Net Profit


89.4


-14.9%


233.4


+4.1%


+0.9%


EPS (yen)


58


-15.4%


150


+3.5%


+0.3%


Operating Cash Flow


92.4


+9.7%


 


 


Free Cash Flow


(Non-IFRS)(a)(b)


-207.5


N/A


 


 


 

(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at https://www.takeda.com/investors/financial-results/.


(b) We define Free Cash Flow as cash flows from operating activities, subtracting acquisition of property, plant and equipment (“PP&E”), intangible assets and investments as well as removing any other cash that is not available to Takeda’s immediate or general business use, and adding proceeds from sales of PP&E, as well as from sales of investments and businesses, net of cash and cash equivalents divested.


(c) Core results adjust our reported results calculated and presented pursuant to IFRS to exclude the effect of items unrelated to Takeda’s core operations, such as, to the extent applicable for each line item, non-recurring items, purchase accounting effects and transaction related costs, as well as amortization and impairment of intangible assets and other operating income and expenses.


(d) Actual Exchange Rate is presented in “AER” (which is presented in accordance with IFRS). Constant Exchange Rate (CER) change eliminates the effect of foreign exchange rates from year-over-year comparisons by translating Reported or Core results for the current period using corresponding exchange rates in the same period of the previous fiscal year.


FY2023 Outlook (unchanged from May 2023)


(Billion yen)


FY2023

FORECAST


FY2023

MANAGEMENT GUIDANCE

Core Change at CER

(Non-IFRS)


Revenue


3,840.0


 


Core Revenue


3,840.0


Low-single-digit % decline


Reported Operating Profit


349.0


 


Core Operating Profit


1,015.0


Low-10s % decline


Reported Net Profit


142.0


 


Reported EPS (Yen)


91


 


Core EPS (Yen)


434


Low-20s % decline


Free Cash Flow*


400.0 - 500.0


 


Annual Dividend per Share (Yen)


188


 


*Free Cash Flow guidance reflects expenditures related to the acquisition of TAK-279 from Nimbus (USD 1.0 billion) and in-licensing of fruquintinib from HUTCHMED (USD 400 million). In FY2022, Takeda paid USD 3.0 billion out of USD 4.0 billion upfront payment related to the acquisition of TAK-279. For the remaining USD 1.0 billion payment, Takeda paid USD 0.9 billion in April 2023, with USD 0.1 billion to be paid in August 2023.


Additional Information About Takeda’s Q1 Earnings Results

For more details on Takeda’s FY2023 Q1 results and other financial information, including key assumptions in FY2023 forecast and management guidance, please visit: https://www.takeda.com/investors/financial-results/.

For more information on Takeda’s commercial progress across the five key business areas and pipeline updates, please visit: https://takeda.info/qr2023_q1_qfr_en


About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.


Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.


The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.


The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners.


Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); the extent to which our internal energy conservation measures and future advancements in renewable energy or low carbon energy technology will enable us to reduce our greenhouse gas emissions; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this report or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this report may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.


Financial information and Certain Non-IFRS Financial Measures

Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”).


This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, EBITDA, Adjusted EBITDA and Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this presentation. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. By including these non-IFRS measures, management intends to provide investors with additional information to further analyze Takeda’s performance and core results, including when controlling for the effect of fluctuations in exchange rates. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS financial measures to their most directly comparable IFRS measures, which are in the financial appendix at the end of Takeda's FY2023 Q1 investor presentation (available at takeda.com/investors/financial-results).


Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.


Please refer to slide 14 of Takeda’s FY2023 Q1 investor presentation (available at takeda.com/investors/financial-results) for the definition of Growth & Launch Products.


 


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Contacts

Investor Relations

Christopher O’Reilly

Christopher.oreilly@takeda.com

+81 (0) 3-3278-2543


Media Relations

Brendan Jennings

Brendan.jennings@takeda.com

+81 (0) 3-3278-2111


 

Mouser Electronics Shares the Revolutionary Power of Digital Therapeutics in Latest Empowering Innovation Together Series

 


 (BUSINESS WIRE)--Mouser Electronics Inc., the industry's leading New Product Introduction (NPI) distributor with the widest selection of semiconductors and electronic components™, premieres its latest installment of the Empowering Innovation Together (EIT) series unveiling the transformative potential of digital therapeutics. Mouser examines the bridge between technology and medical devices to find how these parts and components can work together to provide a more personalized and accessible means of healthcare.

The medical industry is constantly evolving, and technology has become a crucial aspect in changing traditional methods. Digital therapeutics have emerged as an efficient approach that offers the potential to reach more patients, monitor conditions in real time, and reduce the financial barriers to accessing medical care. To support this shift, Mouser and its industry-leading supplier partners have collaborated to share their collective expertise and promote a more comprehensive method of personal health.

The latest series installment includes a brand-new podcast episode from The Tech Between Us, as well as a second episode from In Between The Tech, featuring esteemed guests from the Digital Medicine Society and Freespira. Each episode breaks down the meaning of digital therapeutics and the cutting-edge solutions it has the potential to provide. Through these informative episodes, listeners will gain a comprehensive understanding of the technical hardware and software aspects of engineering design, along with the current industry challenges facing this area.

Mouser's articles, case study and infographics offer a comprehensive exploration of the present market landscape while also presenting an optimistic outlook on future prospects, such as advancements in wearable technology, FDA approval procedures, and the diverse range of treatments it can facilitate. The range of content helps provide a solid foundation and raise awareness among designers about how to incorporate modern solutions into digital therapeutic devices.

This EIT installment is sponsored by Mouser's valued partners ams Osram, Microchip Technology, Bourns, Murata, NXP Semiconductors, Molex, and Renesas.

Established in 2015, Mouser's Empowering Innovation Together program is one of the industry's most recognized electronic component programs. To learn more, visit https://www.mouser.com/empowering-innovation/ and follow Mouser on FacebookLinkedInTwitter and YouTube.

For more Mouser news, visit https://www.mouser.com/newsroom/.

As a global authorized distributor, Mouser offers the world's widest selection of the newest semiconductors and electronic components — in stock and ready to ship™. Mouser's customers can expect 100% certified, genuine products that are fully traceable from each of its manufacturer partners. To help speed customers' designs, Mouser's website hosts an extensive library of technical resources, including a Technical Resource Center, along with product data sheets, supplier-specific reference designs, application notes, technical design information, engineering tools and other helpful information.

Engineers can stay abreast of today's exciting product, technology and application news through Mouser's complimentary e-newsletter. Mouser's email news and reference subscriptions are customizable to the unique and changing project needs of customers and subscribers. No other distributor gives engineers this much customization and control over the information they receive. Learn about emerging technologies, product trends and more by signing up today at https://sub.info.mouser.com/subscriber/.

About Mouser

Mouser Electronics, a Berkshire Hathaway company, is an authorized semiconductor and electronic component distributor focused on New Product Introductions from its leading manufacturer partners. Serving the global electronic design engineer and buyer community, the global distributor's website, mouser.com, is available in multiple languages and currencies and features more than 6.8 million products from over 1,200 manufacturer brands. Mouser offers 27 support locations worldwide to provide best-in-class customer service in local language, currency and time zone. The distributor ships to over 650,000 customers in 223 countries/territories from its 1 million-square-foot, state-of-the-art distribution facilities in the Dallas, Texas, metro area. For more information, visit https://www.mouser.com/.

Trademarks

Mouser and Mouser Electronics are registered trademarks of Mouser Electronics, Inc. All other products, logos, and company names mentioned herein may be trademarks of their respective owners.

 



Contacts

For further information, contact:
Kevin Hess, Mouser Electronics
Senior Vice President of Marketing
+1 (817) 804-3833
Kevin.Hess@mouser.com

Heidi Elliott, Mouser Electronics
Empowering Innovation Together
Marketing Communications Director
+1 (817) 804-2320
Heidi.Elliott@mouser.com

For press inquiries, contact:
Kelly DeGarmo, Mouser Electronics
Manager, Corporate Communications and Media Relations
+1 (817) 804-7764
Kelly.DeGarmo@mouser.com


Aleph Farms Submits First Ever Application for Cultivated Meat in Europe

 REHOVOT, Israel - Wednesday, 26. July 2023 AETOSWire Print 


Application submitted in coordination with Migros to commercialize Aleph Cuts in Switzerland


(BUSINESS WIRE)--Aleph Farms, a cellular agriculture company that enhances sustainability, food security and animal welfare in our food systems, today announced that it has submitted an application for regulatory approval to the Swiss Federal Food Safety and Veterinary Office (FSVO) with the goal of selling the world’s first cultivated beef steaks under the Aleph Cuts brand in Switzerland. The submission is part of Aleph’s collaboration with Migros, Switzerland’s largest food enterprise, which has been instrumental in assessing the country’s specific regulatory approval process.


Aleph Farms is leveraging the expertise and infrastructure of leaders in food production, including Migros, which first invested in the company in 2019, to help accelerate scale-up, go-to-market activities and commercialization of Aleph Cuts worldwide. Together, Aleph and Migros have since conducted extensive consumer research in Switzerland and navigated the intricacies of the country’s regulatory landscape for novel foods. As part of their agreement, the two companies will continue to develop a go-to-market strategy that involves distribution and commercialization of Aleph Cuts through fine dining food service channels in Switzerland.


“Food systems affect everyone, and it will take a coordinated effort between regulators, innovators and incumbents to ensure food security in a way that helps humanity live within its planetary boundaries,” said Didier Toubia, Co-Founder and CEO of Aleph Farms. “At Aleph Farms, we carefully consider partnerships that reflect our core values and sustainability commitments. Together with Migros, we are establishing the cow cell as the third category of food products from cattle, alongside beef and milk. We look forward to working closely with Switzerland's Federal Food Safety and Veterinary Office to enable access to both high-quality nutrition and world-changing innovation.”


Switzerland is a country with a high affinity for innovation. According to research conducted jointly by Aleph Farms and Migros, 74% of Swiss consumers are open to trying cultivated meat and are motivated to try it chiefly by curiosity and a desire to align with principles like sustainability and animal welfare.


Alongside sustainable animal agriculture, cellular agriculture can help increase resilience and stability in the supply of animal proteins and fats to diners in Switzerland. In addition, acceptance by Swiss consumers – known for a quality-conscious attitude towards food – can contribute further to cultivated meat’s growing momentum worldwide.


Later this year, Aleph Farms plans to launch Aleph Cuts in Singapore and Israel in limited quantities and offer exclusive tasting experiences curated with select partners, pending regulatory approvals. Aleph’s regulatory team is working in similar fashion with regulatory authorities in numerous markets around the world, including Switzerland, in order to ensure compliance with respective safety requirements.


About Aleph Farms


Aleph Farms, an Israel-based cellular agriculture company, enhances sustainability, food security and animal welfare in our food systems by diversifying the supply and decentralizing the production of quality animal proteins and fats as a complement to sustainable animal agriculture.


Founded in 2017, the company unveiled the world’s first cultivated thin-cut beef steak in 2018, the world’s first cultivated ribeye steak in 2021, and cultivated collagen in 2022. Under its product brand, Aleph Cuts, the company is launching its first product, the cultivated Petit Steak, grown from non-modified cells of a premium Black Angus cow.


For its contributions to climate leadership including a net zero commitment made in 2020, the company has received top accolades from the World Economic Forum and the United Nations.


For more information, follow Aleph Cuts on Instagram and Facebook, Aleph Farms on Twitter and Linkedin, or visit www.aleph-farms.com. Access our press kit here.


 


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Contacts

Natalee Gibson

alephfarms@songuepr.com


 

Technology Holdings advises DEK Technologies, a software engineering and embedded systems specialist, on its strategic sale to Endava

 


 (BUSINESS WIRE)--Technology Holdings, a global boutique investment bank with offices in North America, Europe and the Asia-Pacific is pleased to announce that it has acted as the exclusive financial advisor to DEK Technologies, a software engineering and embedded systems specialist headquartered in Melbourne, Australia on its strategic sale to Endava.

Founded in 1999 by Drini Mulla, Eddie Yim and Kerim Tanovic, DEK Technologies specialises in software and hardware engineering, and embedded systems. DEK provides cutting edge software and hardware solutions across a diverse range of sectors, with a team of ~700 people located in offices across Australia, Sweden and Vietnam.

With the acquisition of DEK Technologies, Endava will enhance its Asia Pacific (APAC) reach, its presence and customer base in Sweden and a strong telecommunications vertical capability. DEK’s delivery capacities in Vietnam will also serve as a “major delivery” location in the Asia-Pacific. “DEK brings with it great talent, with particular expertise in the globally innovative domains of telecoms and embedded tech,” said John Cotterell, Endava’s CEO. “We’re excited by the opportunity to cross-sell our capabilities to each other’s clients.”

Technology Holdings was an outstanding adviser to us throughout the sale process - their attention to detail and thorough approach was critical in ensuring the deal could get done. Their advice, support and assistance throughout the process was invaluable and the TH team managed and guided us through the complex deal negotiations exceptionally well. They have incredible deal experience within the technology, digital and software engineering space and remained dedicated and supportive throughout the entire journey. Thanks to TH for helping us achieve an incredible outcome!” said Drini Mulla, CEO of DEK Technologies.

Vivek Subramanyam, Founder and CEO of Technology Holdings said, “It has been a great pleasure working with DEK Technologies - their capabilities and team are exceptional and we are thrilled to have delivered the perfect strategic partnership with Endava. This is our 7th engineering services transaction and further demonstrates our deep expertise and leadership in the space."

 



Contacts

Kate Geary
Senior Marketing Manager
Email: kate@technologyholdings.com


The New England Journal of Medicine Publishes Data from Phase 2 Study of First Oral Orexin Receptor 2 Agonist TAK-994 in Patients with Narcolepsy Type 1

 OSAKA, Japan & CAMBRIDGE, Mass. - Thursday, 27. July 2023 AETOSWire 


Trial Was Stopped Due to Hepatotoxicity and Consequently TAK-994 Program Terminated for Further Development

In Patients with Narcolepsy Type 1, Oral Orexin Receptor 2 Agonist Demonstrated Statistically Significant Improvement in Daytime Wakefulness; Weekly Cataplexy Rates Reduced or Abolished at All Doses Compared to Placebo

Findings Indicate Orexin Receptor 2 as Promising Novel Biologic Target for Future Development of Narcolepsy Type 1 Treatments

Takeda Continues to Advance a Multi-Asset Orexin Agonist Franchise

(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine. These data represent the first-ever clinical data to be published of an oral orexin agonist in NT1. The article appears in the July 27 issue of the journal and is titled, “Oral Orexin Receptor 2 Agonist in Narcolepsy Type 1.”


“There is significant unmet need for patients with narcolepsy, a chronic neurologic disease caused by severe loss or absence of the neuropeptide orexin, also known as hypocretin. Today, most patients with NT1 require multiple therapies that only manage excessive daytime sleepiness and cataplexy. Moreover, none of the available agents target the underlying cause of the disease,” said one of the TAK-994 study principal investigators Yves Dauvilliers, M.D., Director, Sleep-Wake Disorders Center, Department of Neurology, Gui de Chauliac Hospital, Montpellier, France. “Although this study was not designed to compare TAK-994, the first-in-class oral OX2R agonist, with other narcolepsy drugs, its effectiveness on objective measures of wakefulness, self-reported assessment of daytime sleepiness, and frequency of cataplexy was impressive. However, TAK-994 was associated with hepatotoxicity, therefore studies with new well tolerated OX2R agonists are strongly requested.”


About the TAK-994-1501 Phase 2 Study

Patients aged 18-65 years with confirmed NT1 were randomly assigned to twice-daily oral TAK-994 30, 90, 180 mg, or placebo.


Primary endpoint was the change in mean sleep latency in minutes on the Maintenance of Wakefulness Test (MWT) from baseline to week 8 (test range: 0-40, normal >=20 minutes).

Secondary endpoints included change in Epworth Sleepiness Scale (ESS) score (scale range: 0-24, normal <10), weekly cataplexy rate (WCR), and treatment-emergent adverse events (TEAEs).

Patients completing the Phase 2 treatment period were eligible for inclusion in an extension trial. Limitations of the trial are that it was terminated early, the number of participants was small, and there was substantial dropout and missing data. The trial was prematurely terminated due to hepatotoxicity in several patients and this agent will not go forward as a treatment for narcolepsy but may indicate a biologic target for future development. Another Takeda oral OX2R agonist is being evaluated in two Phase 2, randomized, double-blind, placebo-controlled trials for the treatment of narcolepsy.


Efficacy Results

Of 73 patients enrolled, 17 received TAK-994 30 mg twice daily, 20 received 90 mg twice daily, 19 received 180 mg twice daily, and 17 received placebo.


Primary endpoint results: Changes in mean sleep latency on MWT to week 8 were available in 56% of patients, with least square means of -2.5 minutes for placebo, 23.9 minutes, 27.4 minutes, and 32.6 minutes (placebo-adjusted least square mean estimates of 26.4 minutes, 29.9 minutes, and 35.0 minutes) for the three doses respectively; P<0.001 for all comparisons.

Secondary endpoint results: Changes in ESS to week 8 were available in 58% of participants with least square means of -2.1 for placebo, -12.2, -13.5, and -15.1 (placebo-adjusted least square mean estimates of -10.1, -11.4, and -13.0) for the three doses respectively. Week 8 WCR were available in 53% of participants, with weekly incidence rate estimates of 5.83 for placebo, 0.27, 1.14, and 0.88 (rate ratio of 0.05, 0.20, and 0.15 relative to placebo) for the three doses respectively.

After 8 weeks of TAK-994, sleep latency on MWT was above the normal threshold (>=20 minutes) for most patients. Similar effects were observed for the ESS.


Safety Results

Forty-four (79%) patients treated with TAK-994 had adverse events; the most common were urinary urgency or frequency. More patients experienced TEAEs with TAK-994 than with placebo, with a greater number and severity of TEAEs observed with higher TAK-994 doses. Most TEAEs were mild in severity. Eight patients exceeded predefined alanine transaminase (ALT) and/or aspartate transaminase (AST) thresholds for subject discontinuation, including three cases meeting Hy’s law criteria (ALT/AST abnormalities >3 x upper limit of normal combined with bilirubin >2 x upper limit of normal; two with TAK-994 180 mg and one with 90 mg), indicating drug-induced hepatotoxicity and leading to the early termination of the trial. No specific risk factors were identified. The current hypothesis is that TAK-994 associated drug-induced liver injury is caused by reactive metabolites and is unlikely to be an on-target effect of OX2R activation as orexin receptors are not expressed on human hepatocytes or on most immune cells.


“As leaders in orexin research and development, Takeda is committed to applying our learnings from the TAK-994 trial and our deep and growing understanding of orexin biology as we drive forward the research and development of multiple orexin assets. We would like to thank the patients, caregivers and investigators who participated in the TAK-994 clinical trials and are committed to continue developing and delivering transformative treatments to people living with narcolepsy and other hypersomnolence disorders. Takeda is also exploring other indications that could benefit from this mechanism,” said Sarah Sheikh, M.Sc., B.M., B.Ch, Head, Neuroscience Therapeutic Area Unit at Takeda. “Orexin programs in development include the oral OX2R agonist TAK-861, currently being evaluated in two Phase 2 trials for the treatment of narcolepsy type 1 (NCT05687903) and narcolepsy type 2 (NCT05687916), and danavorexton (TAK-925), an intravenously administered OX2R agonist we are investigating in a Phase 2 study of people with obstructive sleep apnea after general anesthesia (NCT05814016).”


About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.


Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.


The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.


Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.


Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.


 


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Contacts

 

Media Contacts:


Japanese Media

Yuko Yoneyama

yuko.yoneyama@takeda.com

+81 70-2610-6609


U.S. and International Media

Chris Stamm

chris.stamm@takeda.com

+1 617-374-7726

"EU Organic Deal Showcases Exceptional European Flavors at NATURAL ORGANIC PRODUCTS EXPO UK 2023"

 



In the frame of the implementation of the EU financed campaign “EU Organic Deal” a stand (No N41) was set up at the NATURAL ORGANIC PRODUCTS EXPO UK 2023, which took place on 16-17 of April 2023, at Royal Victoria Dock, 1 Western Gateway, London E16 1XL, with the aim of enhancing consumer awareness regarding organic products in the UK.


 


Esteemed participants from the HoReCa sector, importers, distributors, journalists and other industry stakeholders embraced the opportunity to sample the distinctive European flavors of organic fruit juices, organic olive oil, organic sunflower oil, organic coffee, organic cheese, and organic tea. They also had the chance to explore their exceptional nutritional attributes and engage in discussions for potential collaborations.

 


The EU financed "EU Organic Deal" campaign seeks to showcase and promote organic products from Bulgaria, Romania, and Greece to consumers in the United Kingdom and the United Arab Emirates. These exceptional products adhere to rigorous quality and sustainability standards, prioritizing environmental impact and food safety.


For more information about the EU Organic Deal campaign, the products and the associations, please visit our website https://organicdeal.eu



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Contacts

Melwyn Abraham - melwyn@matrixdubai.com

Republic of Palau Launches US Dollar-backed Palau Stablecoin in the Next Phase of Collaboration with Ripple on the XRP Ledger

 NGERULMUD, Palau & SAN FRANCISCO - Thursday, 27. July 2023

Ripple will provide the Ripple Central Bank Digital Currency Platform and technical resources in a Controlled Pilot


(BUSINESS WIRE)--The Republic of Palau and Ripple have launched a limited stablecoin pilot. Palau and Ripple, the leader in enterprise blockchain and crypto solutions, started collaborating on exploring potential use cases in 2021. The U.S. Dollar-backed Palau Stablecoin (PSC) will be issued on the XRP Ledger (XRPL), a carbon-neutral blockchain that has been used to transact millions of transactions over the course of 10 years, enabling privacy and security for settlement and liquidity of tokenized assets. The pilot program will roll out in phases, with the first phase involving participation from about 200 government employees and local merchants in Palau.


As part of this controlled stablecoin pilot, Palau will also leverage the Ripple CBDC Platform, an end-to-end solution for central banks to issue their own central bank digital currency, as well as the technical resources to make the PSC a digital representation of Palau’s official currency, the U.S. Dollar. The enhanced platform will now allow Palau to holistically manage and customize the entire life cycle of the stablecoin, including distribution and transactions. A stablecoin is a digital unit produced on a blockchain that maintains a fixed value.


In this case, each PSC would be valued at one U.S. Dollar guaranteed by a 1:1 reserve in fiat currency and issued on the XRPL. The operational model follows other reserve-backed private stablecoins, such as USDC or USDT, with a notable difference for the PSC with the involvement of the Republic of Palau’s Ministry of Finance (MOF). The MOF will supervise the system and trigger the issuance and redemption of stablecoin units, while always guaranteeing the 1:1 reserve.


“By digitizing our currency, we hope to mobilize our economy and government processes to improve financial transactions and empower our citizens. As a smaller country, Palau has the advantage to be innovative and nimble in releasing our stablecoin,” said President of the Republic of Palau, Surangel S. Whipps, Jr. “We trust in Ripple’s long-standing expertise in CBDCs and blockchain technology, as well as the carbon-neutral XRP Ledger to help create our national digital currency that will offer our citizens greater financial success,” the President added.


“Ripple is honored to work with the Republic of Palau on implementing their stablecoin to help Palau accelerate their business growth by providing a single source for producing and managing digital currency,” said James Wallis, VP of Central Bank Engagements for Ripple. “Palau is a Pacific Island nation comprising over 200 volcanic and coral islands, filled with unique wildlife and vegetation. Launching the Palau Stablecoin will help the island reduce their carbon footprint and their vulnerability to the impacts of climate change.”


During Phase One of the pilot program, Palau government employees who volunteered for the program will receive an allotment of PSC to be used for the pilot.


The Palau Stablecoin (PSC) will bring many advantages to its citizens, merchants and the government. These benefits include greater financial inclusion and reduced overall transaction fees for citizens. The PSC will also help reduce their currency costs, while considerably accelerating the speed of transactions.


To instill confidence for Palau citizens that the PSC is a secure and effective monetary tool that can support commercial activity in Palau, success criteria of Phase One of the controlled pilot should achieve the following:


The Palau Ministry of Finance (MOF) are able to securely and reliably mint, distribute, and process inbound redemptions, and destroy PSC with full control over total circulation on a 24/7 real-time basis.

Palau government employees are able to make purchases for goods and services at select retailers using the transfer of PSC at the point-of-sale as a means of payment.

Palau retailers are able to safely and securely receive & verify payments made by individuals using the PSC, and are able to convert the received PSC to funds in their local bank account.

Following the success of Phase One of the pilot program, additional phases of the Palau stablecoin will be rolled out later in the year. To learn more about the Palau Stablecoin Project, refer to the FAQs posted online: https://www.palaugov.pw/wp-content/uploads/PALAU-STABLECOIN-FAQs-2.17.23.pdf.


About the Republic of Palau’s Ministry of Finance


The Ministry of Finance of the Republic of Palau’s vision is to be widely recognized for sound financial management services that encourage accountability, continuous productivity of government services, and economic growth. The Ministry’s mission is to ensure accountability, continuous productivity of government services, and economic growth by promoting policies for, and sound management of, expenditures, revenues, financing, and human resources. Ultimately, the Ministry of Finance aims to serve the Republic of Palau with integrity and character with zero tolerance for fraud or corruption.


About Ripple


Ripple is the leader in enterprise blockchain and crypto solutions, transforming how the world moves, manages and tokenizes value. Ripple’s business solutions are faster, more transparent, and more cost effective - solving inefficiencies that have long defined the status quo. And together with partners and the larger developer community, we identify use cases where crypto technology will inspire new business models and create opportunity for more people. With every solution, we’re realizing a more sustainable global economy and planet - increasing access to inclusive and scalable financial systems while leveraging carbon neutral blockchain technology and a green digital asset, XRP. This is how we deliver on our mission to build crypto solutions for a world without economic borders.


About the XRP Ledger


The XRP Ledger (XRPL) is an open source, public and decentralized Layer 1 blockchain led by a global developer community. It is fast, energy-efficient, and reliable. For more than ten years, it has been the blockchain best suited to enable settlement and liquidity of tokenized assets at scale. With ease of development, low transaction costs, and a knowledgeable community, it provides developers with a strong open-source foundation for executing on the most demanding projects – without impacting the XRPL’s lean and efficient feature set. XRPL enables a wide variety of services and use cases including payments, decentralized finance, and tokenization. Learn more at XRPL.org.


 


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Contacts

 

Raquel Prieto, Ripple Global Communications

Press@ripple.com


Oyaol Ngirairikl, Communications, Palau Office of the President

oyaol@palaupresident.info