Friday, October 27, 2023

Hithium Exhibits at All-Energy Australia, Presenting the New 5 MWh Container Product

 (BUSINESS WIRE)--Stationary battery manufacturer Hithium exhibited this week at the most anticipated event in the clean energy sector's annual calendar All-Energy Australia, held in partnership with the Clean Energy Council.


Hithium presents the new 5 MegaWatt hours container the ∞Block using the standard 20-foot container structure. The more compact second generation (ESS 2.0), higher-capacity energy storage system delivers 46% higher energy density than standard systems based on 280 Ah cells. The product will come pre-installed and ready to connect, outfitted with 48 battery modules based on the manufacturer’s new 314 Ah LFP cells, each module providing 104.5 kWh capacity and designed to meet the needs of large utility scale systems. The container will also be technically compatible with most top inverter brands’ power control systems, or bidirectional inverters.


The new energy storage system also comes with Hithium’s mature multi-level, liquid-cooling technology, which keeps cell temperature variation below 3° Celsius. Intelligent thermal management enables the system to optimize battery power and reduce internal energy consumption.


Hithium’s GM of Australia and New Zealand, Vincent She said, “In Australia we have local sales and technical team. Being on the ground in Australia means being able to contribute to the expansion of clean, stable, and affordable energy in a globally leading market. We are ready to support Australia's burgeoning energy storage space with top quality stationary battery products from cell to container.”


With 11GWh of battery products already shipped since the company was founded in 2019, Hithium is expanding its production capacity to 70 GWh by the end of this year. The company has developed some of the most advanced production lines in the world, featuring a high degree of automation and intelligence based on the precise and extensive collection and evaluation of big data, in real time. This enables Hithium to guarantee product stability and consistency in multiple dimensions. The manufacturer’s expansion plans continue into the next several years, with the goal of 135 GWh production capacity by 2025.


About Hithium


Founded in 2019, Hithium is a leading manufacturer of top-quality stationary energy storage products for utility-scale as well as commercial and industrial applications. With four distinct R&D centers and multiple “intelligent” production facilities, Hithium’s innovations include groundbreaking safety improvements to its lithium-ion batteries as well as increases in lifecycle. With decades of cumulative experience in the field among its founders and senior executives, Hithium leverages its specialization in BESS to deliver partners and customers unique advances in energy storage. The company is based in Xiamen, China, with operations in the U.S., Australia, Dubai, and Europe.


 


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carol.wu@hithium.com

United States International Trade Commission Issues Exclusion Order for Infringing Apple Watches, Finding that Apple Violated U.S. Trade Laws

 WASHINGTON - Friday, 27. October 2023 AETOSWire  


Decision Holds World’s Largest Company Accountable for Its Patent Infringement


(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced that the United States International Trade Commission (USITC) has recommended a limited exclusion order for infringing Apple Watches with light-based pulse oximetry functionality. The USITC found that Apple (NASDAQ: AAPL) violated U.S. laws by incorporating Masimo’s patented light-based pulse oximetry technology in its products. The exclusion is scheduled to go into effect after a 60-day Presidential review period.


“Today’s ruling by the USITC sends a powerful message that even the world’s largest company is not above the law,” said Joe Kiani, Founder, Chairman, and CEO of Masimo. “This important determination is a strong validation of our efforts to hold Apple accountable for unlawfully misappropriating our patented technology,” added Mr. Kiani.


Comments from two dozen academic institutions, leading antitrust and intellectual property scholars, physicians, investors, nonprofits, and members of Congress were filed in support of the public’s interest in the exclusion order. These comments conveyed a similar message: to protect innovation, such as Masimo’s technology, and to protect public health, it is necessary to preserve incentives to innovate and protect intellectual property and fair competition.


In its comment submitted to the ITC, the Consumer Federation of America stated, “There is no greater offense to both the antitrust and intellectual property law than when a dominant firm infringes the patent of a smaller rival, who is an actual or potential competitor. In this case, as in the other cases involving Apple’s egregious abuse of market power, the harms far outweigh the benefit. In fact, because competition will swiftly replace any services or products that Apple is no longer able to deliver because of the remedy, there will be little harm and a great deal of benefit for consumers and the economy.”


@Masimo | #Masimo


About Masimo


Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.1 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,2 improve CCHD screening in newborns3 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.4-7 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,8 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.9 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7®, Radius PPG®, and Radius VSM™, portable devices like Rad-67®, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, iSirona™, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Its growing portfolio of health and wellness solutions includes Radius Tº®, Masimo W1™, and Masimo Stork™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.


RPVi has not received FDA 510(k) clearance and is not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.


References


Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.

Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.

de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.

Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.

Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.

Estimate: Masimo data on file.

http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements


This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to further proceedings, including the Presidential review period and any appeals, as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.


 


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Contacts

 

Masimo

Kristen Budreau

949-433-5847

kbudreau@masimo.com

Tecnotree Awarded a Ground-breaking Sensa AIML Embedded BSS Transformation Deal with a Leading Operator in the MENA Region


 ESPOO, Finland

(BUSINESS WIRE) -- Tecnotree, a global digital platform and services leader for AI, 5G, and cloud-native technologies, announced being awarded a new multimillion-dollar deal with a leading provider of a range of telecom solutions in the MENA region. With this Project, Tecnotree aims to provide AI-embedded BSS customer engagement for the operator. The deal, implementing full BSS stack along with the Tecnotree Sensa Intelligence platform, is the second win for Tecnotree in terms of AIML-driven customer experience use case in 2023.


Tecnotree Sensa is an AI-enabled technology that cuts across the Tecnotree portfolio, by enabling configurable AI solutions and humanizing digital experiences with intelligence across telcos as well as various other industry verticals. The 5G and AI-enabled digital experiences from Tecnotree Sensa deepen customer engagement, increase operational effectiveness, and support 5G-driven monetization.


As part of the agreement, Tecnotree will deploy Sensa AI embedded BSS applications including, digital selfcare and customer management, catalogue driven order management, demand generation through omnichannel campaigns and social media insights, lead and funnel management, enterprise workforce management with business process orchestration, business intelligence and analytics capabilities, enterprise and consumer service request management, partner management, e-shop. The solution will provide the operator with a unified solution with embedded intelligence for transformation across all applications, that enables B2B2X cross-sell and up-sell capabilities.


Commenting on the new deal, Padma Ravichander, CEO of Tecnotree Corporation, said, “We are very excited to embark on this new chapter as we help the customer redefine unparalleled digital experiences and create new revenue streams, with the help of our complete Digital BSS and AIML Sensa Fabric platforms for their business transformation. Our digital BSS stack embedded with Tecnotree Sensa AIML capabilities will enable the customer to improve business agility and respond faster to market dynamics, while humanising experiences with hyper-personalisation. It will also help them optimise operational costs, while significantly improving revenue monetisation capability with our AI/ML based insights and recommendations. The collaboration marks a significant stride for Tecnotree in the field of artificial intelligence, reinforcing our commitment to enhance digital services that create business differentiation and help our customers deliver second-to-none customer experiences.”


About Tecnotree


Tecnotree is a 5G-ready digital Business Support System (BSS) player, with AI/ML capabilities and multi-cloud extensibility. Tecnotree is No. 1 on the TM Forum Open API Conformance table with 59 Open APIs, and this is a result of our pursuit towards delivering excellence, and consistently providing differentiated experiences and services to the CSPs and DSPs. Our agile and open-source Digital BSS Stack comprises the full range (order-to-cash) of business processes and subscription management for telecom and other digital services industries creating opportunities beyond connectivity. Tecnotree also provides Fintech and B2B2X multi-experience digital marketplace to its subscriber base through the Tecnotree Moments platform to empower digitally connected communities across gaming, health, education, OTT, and other vertical ecosystems. Tecnotree is listed on the Helsinki Nasdaq (TEM1V).


For more information, please visit www.tecnotree.com


 


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Contacts

Padma Ravichander, CEO Tecnotree

Email: marketing@tecnotree.com

Galderma Phase III Data Published in the New England Journal of Medicine: Full OLYMPIA 2 Trial Results Demonstrate Nemolizumab’s Rapid Onset of Action in Prurigo Nodularis Patients

ZUG, Switzerland - Thursday, 26. October 2023

  • The phase III OLYMPIA 2 trial in patients with prurigo nodularis met all primary and key secondary endpoints, showing nemolizumab monotherapy significantly and rapidly improves itch and skin lesions, with clinically meaningful improvements as early as week 4.1
  • Nemolizumab was well tolerated, and its safety profile was consistent with phase II trial results.1
  • Results were published in the 389th edition of the New England Journal of Medicine, which follows the 2020 publication of nemolizumab’s phase IIB trial results in the same journal.2
  • Nemolizumab is a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, a neuroimmune cytokine responsible for driving multiple disease mechanisms in prurigo nodularis.
  • The OLYMPIA 2 trial is part of the largest phase III clinical development program in prurigo nodularis to date.

 
(BUSINESS WIRE) -- Galderma today announced that the New England Journal of Medicine has published full results from the phase III OLYMPIA 2 trial evaluating the efficacy and safety of nemolizumab monotherapy in adults with prurigo nodularis. The trial met both primary and all key secondary endpoints, demonstrating that nemolizumab-treated patients had significantly higher improvements in itch and skin lesions when compared to those receiving placebo, with a rapid and clinically meaningful response on itch, observed as early as week 4. Nemolizumab was well tolerated, and its safety profile was consistent with phase II trial results.1

“We are proud that the clinical trial results of nemolizumab in prurigo nodularis have been published in the prestigious New England Journal of Medicine for a second time, which is testament to the robustness of our scientific method and quality of evidence supporting its efficacy. We believe nemolizumab has the potential to be a rapidly effective treatment option for patients with prurigo nodularis, with improvements on itch and skin lesions observed as early as week 4.”

FLEMMING ØRNSKOV, M.D., MPH
CHIEF EXECUTIVE OFFICER
GALDERMA

The phase III OLYMPIA 2 trial enrolled 274 adult patients with moderate to severe prurigo nodularis. Results demonstrated that patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically meaningful and statistically significant improvements in both primary endpoints, compared to placebo, after 16 weeks of treatment:

    More than twice as many nemolizumab-treated patients achieved an at least four-point improvement in itch intensity, as measured by the peak-pruritus numerical rating scale (PP-NRS), when compared to the placebo group (56.3% vs 20.9%; p<0.0001).

    More than three times as many nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment score, compared to the placebo group (37.7% vs 11.0%; p<0.0001).

The trial also met all key secondary endpoints confirming rapid responses on itch and sleep disturbance as early as week 4:

    More than five times as many nemolizumab-treated patients achieved itch response when compared to the placebo group (41.0% vs 7.7%; p<0.001), as measured by a four-point or greater reduction in PP-NRS score.

    More than eight times as many patients achieved a PP-NRS score of less than two, when compared to the placebo group (19.7% vs 2.2%; p<0.001). Results improved through to week 16 (35.0% vs 7.7%; p<0.001).

    More than three times as many nemolizumab-treated patients demonstrated a four-point improvement in sleep disturbance, as measured by the sleep disturbance numerical rating scale, when compared to the placebo group (37.2% vs 9.9%; p<0.001). Results improved through to week 16 (51.9% vs 20.9%; p<0.001).

Nemolizumab is an investigational monoclonal antibody specifically designed to target the IL-31 receptor and inhibit IL-31 signaling. IL-31 plays a key role in multiple disease mechanisms in prurigo nodularis, including itch signaling, epidermal changes and fibrosis.3-7 This includes directly addressing the source of itch, which causes sleep disturbance and negatively impacts quality of life outcomes.4-8

“Chronic itch is by far the most burdensome symptom for patients with prurigo nodularis, and this is often poorly controlled. The fact that nemolizumab – by inhibiting IL-31 signaling – has the potential to provide a new treatment type that rapidly improves both itch and skin lesions is exciting news.”

DR SHAWN KWATRA, M.D., PH.D.
LEAD STUDY AUTHOR
PROFESSOR OF DERMATOLOGY AT JOHN HOPKINS UNIVERSITY
DIRECTOR, JOHNS HOPKINS ITCH CENTER, UNITED STATES

Galderma is investigating the use of nemolizumab and has not received approval in any jurisdiction for any indication. Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of itch associated with prurigo nodularis, a status reconfirmed in March 2023. Results from the phase III OLYMPIA 2 trial will be submitted to selected health authorities around the world.

To learn more about prurigo nodularis, watch this video from the New England Journal of Medicine. Media can also find more information via the prurigo nodularis media toolkit.

About prurigo nodularis
Prurigo nodularis is a debilitating chronic skin condition characterized by thick skin nodules covering large body areas and associated with intense itch (pruritus).3,9-10 Prurigo nodularis affects an estimated 72 out of every 100,000 adults aged 18 to 64 in the United States. It is more common in middle-aged women and, disproportionately, people of African descent.3,11

About nemolizumab
Nemolizumab is in clinical development for the treatment of atopic dermatitis and prurigo nodularis in many countries around the world. It was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis.

About the OLYMPIA 2 trial
OLYMPIA 2 was a randomized, double-blind, placebo-controlled phase III clinical trial designed to assess the efficacy and safety of nemolizumab monotherapy compared with placebo in patients aged at least 18 with prurigo nodularis after a 16-week treatment period. The trial also assessed the pharmacokinetics and immunogenicity of nemolizumab compared to placebo. OLYMPIA 2 included 274 patients with moderate to severe prurigo nodularis.

About Galderma
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

    Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. DOI: 10.1056/NEJMoa2301333

    Ständer S, et al. Trial of nemolizumab in moderate-to-severe prurigo nodularis. N Engl J Med. 2020; 382:706-716. DOI:10.1056/NEJMoa1908316

    Williams KA, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14(1):67-77. DOI:10.1080/17512433.2021.1852080

    Nemmer JM, et al. Interleukin-31 signaling bridges the gap between immune cells, the nervous system and epithelial tissues. Front Med (Lausanne). 2021;8:639097. DOI:10.3389/fmed.2021.639097

    Wang F, Kim BS. Itch: a paradigm of neuroimmune crosstalk. Immunity. 2020;52(5):753-766. DOI:10.1016/j.immuni.2020.04.008

    Zhang Q, et al. Structures and biological functions of IL-31 and IL-31 receptors. Cytokine Growth Factor Rev. 2008;19(5-6):347-356. DOI:10.1016/j.cytogfr.2008.08.003

    Tsoi LC, et al. Transcriptomic characterization of prurigo nodularis and the therapeutic response to nemolizumab. J Allergy Clin Immunol. 2021;S0091-6749(21)01557-8. DOI:10.1016/j.jaci.2021.10.004

    Gwillim EC, Nattkemper L, Yosipovitch G. Impact of itch on sleep disturbance in patients with prurigo nodularis. Acta Derm Venereol. 2021;101(3):adv00424. DOI:10.2340/00015555-3778. PMID: 33704503

    Elmariah S, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021;84(3):747-760. DOI:10.1016/j.jaad.2020.07.025

    Whang KA, et al. Prevalence of prurigo nodularis in the United States. J Allergy Clin Immunol Pract. 2020;8(9):3240-3241. DOI:10.1016/j.jaip.2020.05.051

    Huang AH, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. DOI:10.1016/j.jid.2019.07.697

 

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Contacts

Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50

Sébastien Cros
Corporate Communications Director
sebastien.cros@galderma.com
+41 79 529 59 85

Emil Ivanov
Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen
Investor Relations and Strategy Director
jessica.cohen@galderma.com
+41 21 642 76 43

Takeda Announces FY2023 H1 Results; Updates Full-Year Forecasts While Remaining on Track Towards Management Guidance

 OSAKA, Japan & CAMBRIDGE, Mass. - Thursday, 26. October 2023 AETOSWire


Revenue Growth of +6.4% at Actual Exchange Rate (AER); +1.4% Growth at Constant Exchange Rate (CER), Driven by Growth & Launch Products (+13% at CER)

Core Operating Profit Year-on-Year Change of -9.5% at CER Reflecting Generic Impact, Lower Demand for Coronavirus Vaccines and Increased Investment in R&D and Data & Technology

Reported Operating Profit and Net Profit Impacted by Non-Cash Impairment of Intangible Assets Booked in Q2

Raising Full Year Revenue and Core EPS Forecasts to Reflect Updated FX and Tax Rate Assumptions; Lowering Full-Year Profit Forecasts on a Reported Basis Due to Non-Core Items Booked in Q2

No Change to Free Cash Flow Outlook or Management Guidance

 


(BUSINESS WIRE) -- Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the first half of fiscal year 2023 (six months ended September 30, 2023), updating reported and Core forecasts and reconfirming Management Guidance for Core change at CER.


Takeda chief executive officer, Christophe Weber, commented:

“We continue to pursue our vision to discover and deliver life-transforming treatments, making further progress in the first half of our fiscal year to address unmet medical needs and provide new treatment options to improve patient outcomes and quality of life. Our pipeline is robust and we anticipate a number of important milestones in the second half of the fiscal year, including potentially up to three new product approvals in the U.S., for TAK-755, fruquintinib, and TAK-721.


“Development setbacks with EXKIVITY® and ALOFISEL®, which impacted our reported profit in FY2023 Q2, highlight the inherent risk in research and development in the pharmaceutical business, but do not hinder our strategy for a return to growth in the near-term and our confidence in the long-term strength of the business remains firm.”


Takeda chief financial officer, Costa Saroukos, commented:

“We are raising our full-year revenue and Core EPS forecasts to reflect updated foreign exchange and tax rate assumptions, while revising our reported operating profit and EPS forecasts to reflect large non-core items booked in our second quarter. These items do not reflect the underlying momentum of the business, and we remain on track to our Management Guidance, which is on a Core basis at CER.


“We continue to see strong performance of our Growth and Launch Products, which grew +13% at CER in the first half of the fiscal year and represent 42% of total revenue. While our Core revenue and profit performance in the first half continued to reflect the temporary headwinds we face this fiscal year, largely from generic competition, we believe our Growth and Launch Products will drive a return to revenue and profit growth in the near-term.”


FINANCIAL HIGHLIGHTS 


Results for FY2023 H1 Ended September 30, 2023


(Billion yen,

except

percentages and

per share

amounts)


REPORTED


 


CORE(c)


 


(Non-IFRS)(a)


 


FY2023 H1


vs. PRIOR YEAR


(Actual % change)


FY2023 H1


vs. PRIOR YEAR


 


(Actual % change)


vs. PRIOR YEAR


 


(CER % change(d))


Revenue


2,101.7


+6.4%


2,101.7


+6.4%


+1.4%


Operating Profit


119.2


-53.2%


588.8


-5.8%


-9.5%


Margin


5.7%


-7.2pp


28.0%


-3.6pp


 


Net Profit


41.4


-75.2%


407.7


-8.7%


-13.8%


EPS (yen)


27


-75.4%


261


-9.4%


-14.4%


Operating Cash Flow


291.3


-4.6%


 


 


 


Free Cash Flow

(Non-IFRS)(a)(b)


 


-71.1


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/quarterly-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) CER (Constant Exchange Rate) 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

Updating Full-Year FY2023 Reported and Core Forecasts, and Reconfirming Management Guidance


Based on Takeda’s first half results and reflecting expected foreign exchange rates during the second half of FY2023, Takeda’s reported and Core forecasts have been revised from the original forecast.


(Billion yen except per share amounts)


FY2023 ORIGINAL

FORECAST

(May 2023)


 


FY2023 REVISED

FORECAST

(October 2023)


 


FY2023 MANAGEMENT

GUIDANCE

Core Growth at CER

(Non-IFRS)

(Unchanged from May 2023)


Revenue


3,840.0


3,980.0


 


Core Revenue


3,840.0


3,980.0


Low-single-digit % decline


Reported Operating Profit


349.0


225.0


 


Core Operating Profit


1,015.0


1,015.0


Low-10s % decline


Reported Net Profit


142.0


93.0


 


Reported EPS (yen)


91


59


 


Core EPS (yen)


434


447


Low-20s % decline


Free Cash Flow*


400.0-500.0


400.0-500.0


 


Annual Dividend per Share (yen)


188


188


 


*Free Cash Flow forecast reflects expenditures related to the acquisition of TAK-279 from Nimbus (JPY134.1 billion) and in-licensing of fruquintinib from HUTCHMED (JPY55.1 billion).


Additional Information About Takeda’s H1 Earnings Results

For more details on Takeda’s FY2023 H1 results and other financial information, including key assumptions in FY2023 forecast and management guidance, please visit: https://www.takeda.com/investors/financial-results/quarterly-results/.


For more information on Takeda’s commercial progress across the five key business areas and pipeline updates, please visit: https://takeda.info/qr2023_q2_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-and-security-reports/ 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 Q2 investor presentation (available at takeda.com/investors/financial-results/quarterly-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 19 of Takeda’s FY2023 Q2 investor presentation (available at takeda.com/investors/financial-results/quarterly-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


 

CIOs and CTOs Struggle with Multiple Vendor-Based Support and Services Model, According to New Survey

 LAS VEGAS - Thursday, 26. October 2023

IT leaders seek to consolidate support and services into a single vendor to achieve greater agility, control vulnerabilities, and improve cost efficiency


(BUSINESS WIRE) -- Rimini Street, Inc. (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, products and services, the leading third-party support provider for Oracle and SAP software, and a Salesforce and AWS partner, today announced findings of the Censuswide Buyers Sentiment Survey, “IT Leaders are Considering a New Support and Services Model,” examining the challenges of ERP and database support, vendor relationship management, and the need for a better IT support and services model. The research was conducted among a sample of more than 600 U.S. respondents, consisting of CIOs and CTOs in companies with over $250m in revenue. It is the second in a two-part series of reports from Censuswide, following the recent “Organizations Want More Control Over Their IT Roadmap” report.


The survey results show that organizations are juggling an increased number of vendors, products, and services in the enterprise applications portfolio, putting stress on today’s support models and straining the IT budget. Nearly three quarters of respondents say these models are inadequate in supporting their IT and business needs.


“Over the past decade, enterprises have deployed a growing number of enterprise software systems and supporting technologies to run their business. This has left them dependent on a tangled web of software vendors and service providers to support and manage these mission-critical systems,” said David Rowe, EVP, Global Transformation and chief product officer. “The data illustrates that this system simply isn’t working for the enterprise customer. Without a concerted effort across the providers, it places greater responsibility on IT leaders to coordinate and manage the various systems and vendors. Today, there’s a better alternative: Consolidating support and services into a single strategic partner that prioritizes business success and works closely to help plan and execute a digital transformation roadmap that fits the company’s goals.”


CIOs and CTOs Say Multi-Vendor Support and Services Model Lacks Agility and Accountability


Key findings include:


When asked to assess the support and services they receive for their Enterprise Resource Planning (ERP) systems, databases, and related technology, 72% of CIOs and CTOs say the vendor-based model is inadequate, citing a lack of accountability (62%) and lack of expertise (46%) as top challenges


With challenges of managing multiple support and service providers, respondents cited the different process per vendor (36%), the high cost of several vendor contracts (35%), and too much effort selecting and managing vendors (35%) as the greatest pain points


61% of respondents want to consolidate support and managed services into a single provider


The data shows that technology leaders are experiencing critical challenges with their IT support and services. A lack of accountability means that companies may suffer recurring product issues as there is often no root cause resolution, forcing them to explain the same problem to their individual vendors over and over again. In addition, the vendor support teams frequently offer limited expertise, leading enterprises to consult independent experts or escalate to their own experienced engineers. This costs organizations critical time and resources.


Vendor Consolidation is Just the First Step in Addressing Complexity


The report specifically details how relying on support and services from multiple vendors makes operations even more complex and expensive for CIOs and CTOs. In these multi-vendor models, respondents state that different vendors blame each other for problems (34%), service handoffs are lost between vendors (29%), and project lead times are longer (27%).


These problems extend beyond just cost and operational complexity, also harming cybersecurity efforts. The multi-vendor support and services model can have a multiplying effect on existing security issues. The data reveals these five top security challenges:


Keeping up with the volume of vulnerabilities on a quarterly basis (31%)


Balancing operational resources between “keeping the lights on” and strategic priorities (30%)


Finding a way to stay ahead of an increasing volume of threats (30%)


Avoiding business disruptions by security enhancements (30%)


Upgrading software to be eligible for security patches (29%)


Offering a single point of support and service to today’s technology leaders is just the first step in addressing the challenge of the multiple vendor-based support and services model. Providers must also ensure they can demonstrate the added value that consolidation brings, such as the ability to give objective, agnostic, and personalized roadmap guidance. Ultimately, IT leaders are looking to their providers for agility, flexibility, and for a strategic partner to help plan their digital transformation roadmap and see it through to success.


You can access the full, comprehensive report of the survey, “IT Leaders are Considering a New Support and Services Model,” here.


About Rimini Street, Inc.


Rimini Street, Inc. (Nasdaq: RMNI), a Russell 2000® Company, is a global provider of end-to-end enterprise software support, products and services, the leading third-party support provider for Oracle and SAP software and a Salesforce and AWS partner. The Company has operations globally and offers a comprehensive family of unified solutions to run, manage, support, customize, configure, connect, protect, monitor, and optimize enterprise application, database, and technology software, and enables clients to achieve better business outcomes, significantly reduce costs and reallocate resources for innovation. To date, over 5,200 Fortune 500, Fortune Global 100, midmarket, public sector, and other organizations from a broad range of industries have relied on Rimini Street as their trusted enterprise software solutions provider. To learn more, please visit riministreet.com, and connect with Rimini Street on Twitter, Instagram, Facebook and LinkedIn. (IR-RMNI)


Forward-Looking Statements


Certain statements included in this communication are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “anticipate,” “believe,” “continue,” “could,” “currently,” “estimate,” “expect,” “future,” “intend,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seem,” “seek,” “should,” “will,” “would” or other similar words, phrases or expressions. These forward-looking statements include, but are not limited to, statements regarding our expectations of future events, future opportunities, global expansion and other growth initiatives and our investments in such initiatives. These statements are based on various assumptions and on the current expectations of management and are not predictions of actual performance, nor are these statements of historical facts. These statements are subject to a number of risks and uncertainties regarding Rimini Street’s business, and actual results may differ materially. These risks and uncertainties include, but are not limited to, adverse developments in and costs associated with defending pending litigation or any new litigation, including the disposition of pending motions to appeal; additional expenses to be incurred in order to comply with injunctions against certain of our business practices and the impact on future period costs; changes in the business environment in which Rimini Street operates, including the impact of any recessionary economic trends and changes in foreign exchange rates, as well as general financial, economic, regulatory and political conditions affecting the industry in which we operate and the industries in which our clients operate; the evolution of the enterprise software management and support landscape and our ability to attract and retain clients and further penetrate our client base; significant competition in the software support services industry; customer adoption of our expanded portfolio of products and services and products and services we expect to introduce; our ability to sustain or achieve revenue growth or profitability and manage our cost of revenue; estimates of our total addressable market and expectations of client savings relative to use of other providers; variability of timing in our sales cycle, and risks relating to retention rates; the loss of one or more members of our management team; our ability to attract and retain qualified employees and key personnel; challenges of managing growth profitably; our need and ability to raise additional equity or debt financing on favorable terms and our ability to generate cash flows from operations to help fund increased investment in our growth; the impact of environmental, social and governance (ESG) matters; risks associated with global operations; our ability to prevent unauthorized access to our information technology systems and other cybersecurity threats, protect the confidential information of our employees and clients and comply with privacy regulations; our ability to maintain an effective system of internal control over financial reporting; our ability to maintain, protect and enhance our brand and intellectual property; changes in laws and regulations, including changes in tax laws or unfavorable outcomes of tax positions we take, or a failure by us to establish adequate tax reserves; our credit facility’s ongoing debt service obligations and financial and operational covenants on our business and related interest rate risk, including uncertainty from the transition to SOFR or other interest rate benchmarks; the sufficiency of our cash and cash equivalents to meet our liquidity requirements; the amount and timing of repurchases, if any, under our stock repurchase program and our ability to enhance stockholder value through such program; uncertainty as to the long-term value of Rimini Street’s equity securities; catastrophic events that disrupt our business or that of our clients; and those discussed under the heading “Risk Factors” in Rimini Street’s Quarterly Report on Form 10-Q filed on August 2, 2023, and as updated from time to time by Rimini Street’s future Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings by Rimini Street with the Securities and Exchange Commission. In addition, forward-looking statements provide Rimini Street’s expectations, plans or forecasts of future events and views as of the date of this communication. Rimini Street anticipates that subsequent events and developments will cause Rimini Street’s assessments to change. However, while Rimini Street may elect to update these forward-looking statements at some point in the future, Rimini Street specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Rimini Street’s assessments as of any date subsequent to the date of this communication.


© 2023 Rimini Street, Inc. All rights reserved. “Rimini Street” is a registered trademark of Rimini Street, Inc. in the United States and other countries, and Rimini Street, the Rimini Street logo, and combinations thereof, and other marks marked by TM are trademarks of Rimini Street, Inc. All other trademarks remain the property of their respective owners, and unless otherwise specified, Rimini Street claims no affiliation, endorsement, or association with any such trademark holder or other companies referenced herein.


 


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Contacts

Janet Ravin

VP, Global Communications

Rimini Street, Inc.

+1 702 285-3532

pr@riministreet.com


 

Kinaxis Welcomes ProvisionAI to Global Partner Network

 OTTAWA, Ontario - Thursday, 26. October 2023




Partnership combines transportation scheduling capability with real-time data to narrow the gap between planning and execution


 


(BUSINESS WIRE)--ProvisionAI, the only provider of a patented, optimized replenishment transportation scheduling solution, has joined the Kinaxis® (TSX:KXS) solution extension partner program. Through this partnership, joint customers can now extend the visibility and agility gained from the Kinaxis RapidResponse® platform, and its patented concurrent technique, into their transportation scheduling needs; in effect, eliminating latency and siloes.


“The combination of RapidResponse and LevelLoad from ProvisionAI means customers can combine data from their whole network with their transportation data in real time,” said Tom Moore, CEO and founder at ProvisionAI. “By understanding real-time constraints from other parts of the supply chain, customers can create the most up-to-date replenishment transportation schedule that also takes into account lane carrier costs, warehouse capacities and inventory availability. It’s a game changer in supply chain management.”


Kinaxis and ProvisionAI already share several high-profile global customers including Unilever, Diageo, Baxter and Kimberly-Clark.


“Our solution extension partners are vital in the Kinaxis ecosystem, bringing unique and specialized capabilities to our customers,” said Conrad Mandala, senior vice president global partner organization at Kinaxis. “We are thrilled to welcome ProvisionAI to our global partner program and very excited to about what we’ll accomplish together.”


About Kinaxis

Kinaxis is the global leader in modern supply chain management. We serve supply chains and the people who manage them in service of humanity. Our software is trusted by renowned global brands to provide the agility and predictability needed to navigate today’s volatility and disruption. We combine our patented concurrency technique with a human-centered approach to AI to empower businesses of all sizes to orchestrate their end-to-end supply chain network, from multi-year strategic planning through down-to-the-second execution and last-mile delivery. For more news and information, please visit kinaxis.com or follow us on LinkedIn.


About ProvisionAI

ProvisionAI provides global manufacturers with a transportation scheduling solution featuring optimized, capacity-constrained replenishment. LevelLoad, the flagship offering, attains long-term transportation planning objectives despite the realities of supply chain network constraints. The results include fuller loads, higher use of preferred freight carriers, and overall lower costs. Clients save millions by tendering loads early to reserve preferred carriers, filling truckloads optimally to minimize wasted capacity, improving customer order fulfillment, and ratcheting down costs. The patented technology was developed over five years by a team of logistics optimization experts that studied shippers like Unilever, Baxter, P&G, and Kimberly-Clark. For more information, visit www.provisionai.com.


Forward-Looking Statements

Certain statements in this release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements as to Kinaxis' growth opportunities and the potential benefits of, and demand for, Kinaxis’ products and services. These statements are subject to certain assumptions, risks and uncertainties, including our view of the relative position of Kinaxis' products and services compared to competitive offerings in the industry. Readers are cautioned not to place undue reliance on such statements. Kinaxis' actual results, performance, achievements and developments may differ materially from the results, performance, achievements or developments expressed or implied by such statements. Risk factors that may cause the actual results, performance, achievements or developments of Kinaxis to differ materially from the results, performance, achievements or developments expressed or implied by such statements can be found in the public documents filed by Kinaxis with Canadian securities regulatory authorities. Kinaxis assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.


Source: Kinaxis


 


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Contacts

Media Relations

Jaime Cook | Kinaxis

jcook@kinaxis.com

289-552-4640


Investor Relations

Rick Wadsworth | Kinaxis

rwadsworth@kinaxis.com

613-907-7613