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That suggests anyone could set up similar hardware somewhere else in the world and likely obtain their own collection of sensitive information. After all, the researchers restricted their experiment to only off-the-shelf satellite hardware: a $185 satellite dish, a $140 roof mount with a $195 motor, and a $230 tuner card, totaling less than $800.
“This was not NSA-level resources. This was DirecTV-user-level resources. The barrier to entry for this sort of attack is extremely low,” says Matt Blaze, a computer scientist and cryptographer at Georgetown University and law professor at Georgetown Law. “By the week after next, we will have hundreds or perhaps thousands of people, many of whom won’t tell us what they’re doing, replicating this work and seeing what they can find up there in the sky.”
One of the only barriers to replicating their work, the researchers say, would likely be the hundreds of hours they spent on the roof adjusting their satellite. As for the in-depth, highly technical analysis of obscure data protocols they obtained, that may now be easier to replicate, too: The researchers are releasing their own open-source software tool for interpreting satellite data, also titled “Don’t Look Up,” on Github.
The researchers’ work may, they acknowledge, enable others with less benevolent intentions to pull the same highly sensitive data from space. But they argue it will also push more of the owners of that satellite communications data to encrypt that data, to protect themselves and their customers. “As long as we’re on the side of finding things that are insecure and securing them, we feel very good about it,” says Schulman.
There’s little doubt, they say, that intelligence agencies with vastly superior satellite receiver hardware have been analyzing the same unencrypted data for years. In fact, they point out that the US National Security Agency warned in a 2022 security advisory about the lack of encryption for satellite communications. At the same time, they assume that the NSA—and every other intelligence agency from Russia to China—has set up satellite dishes around the world to exploit that same lack of protection. (The NSA did not respond to WIRED’s request for comment).
“If they aren’t already doing this,” jokes UCSD cryptography professor Nadia Heninger, who co-led the study, “then where are my tax dollars going?”
Heninger compares their study’s revelation—the sheer scale of the unprotected satellite data available for the taking—to some of the revelations of Edward Snowden that showed how the NSA and Britain’s GCHQ were obtaining telecom and internet data on an enormous scale, often by secretly tapping directly into communications infrastructure.
“The threat model that everybody had in mind was that we need to be encrypting everything, because there are governments that are tapping undersea fiber optic cables or coercing telecom companies into letting them have access to the data,” Heninger says. “And now what we’re seeing is, this same kind of data is just being broadcast to a large fraction of the planet.”
Goldman analysts upgrade Estee Lauder’s stock, saying a sales rebound could happen sooner than investors think
Goldman Sachs analysts see “an upcoming fundamental inflection” for Estee Lauder as the cosmetics maker tries to turn its fortunes around.
Cosmetics giant Estee Lauder Cos.’s rebound could take hold sooner than expected, Goldman Sachs analysts said on Monday, as trends firm up in the U.S. and China and the company puts more focus on newer and higher-end products and sales through TikTok and Amazon.
The Goldman analysts upgraded shares of Estee Lauder (EL) to a buy rating. That upgrade helped send the stock 5.8% higher on Monday.
The analysts, in a research note, said they saw “an upcoming fundamental inflection” for Estee Lauder, which is known for brands like Clinique and Aveda, along with its namesake products. They added that the company could return to sales growth as soon as its fiscal first quarter, which ran through last month.
“Ultimately, we believe investors need evidence of sustainable toplinegrowth and share gains, and we believe this could happen earlierthan expected (possibly FQ1), and with continued progress on improved profitability, this should drive a re-rating in the stock,” the analysts said.
Higher costs of living, competition, tariffs and an online ecosystem that has sped up trend cycles have weighed on beauty-industry heavyweights. Estee Lauder this year has slashed thousands of jobs and announced plans to accelerate new-product development and take steps to be a bigger player in more upscale beauty products.
In February, Chief Executive Stéphane de La Faverie said that Estee Lauder had been “too slow to seize new opportunities” and that the company planned to deliver nearly a third of its product launches in under 12 months. In August, he called the moves “the biggest organizational transformation that we have done in our history.”
However, management in August said it expected better sales trends for mainland China – a key market that the Goldman analysts said makes up around a quarter of Estee Lauder’s sales – and at places like airport duty-free shops and cruise-ship terminals. Those trends were reasons to be optimistic, the analysts said.
“While there has been some debate around the elevated competition from local brands,” the analysts said of the backdrop in China, “we believe rising urban consumption should support [Estee Lauder’s] growth and the steps it is taking as part of its strategic vision should support further market share gains ahead.”
The analysts also said that while Estee Lauder’s business in North America lost a lot of ground over recent years, it is more diversified today. They said the company has less than one-third of its overall exposure to department stores. The rest, they said, was spread out across Amazon, Estee Lauder’s direct-to-consumer business, and other stores.
That current composition of its business, the analysts said, “should allow the company to reach its consumers in a more effective manner.”
The analysts noted that Estee Lauder first launched Clinique on Amazon in the U.S. last year, which has helped that brand pick up a bigger slice of the market. They said Estee Lauder currently has 11 brands on Amazon in the U.S. The company also recently launched two brands on TikTok Shop.
“Notably, [management] views these platforms as an important part of its new media model wherein these platforms serve the purpose of amplifying demand for its brands as consumers predominantly search for beauty products across these platforms,” the analysts said.
“While department stores will likely get even smaller over time as other growth channels pick-up in the mix,” they added, “we believe department stores remain an important channel to drive trial and certain categories will likely thrive in brick-and-mortar, such as fragrances and luxury skincare.”
-Bill Peters
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An aerial view of Singapore’s Marina Bay Street Circuit on Sept. 17, 2024.
Roslan Rahman | Afp | Getty Images
Singapore’s economy expanded faster than expected in the third quarter, even as the country’s central bank warned that growth is likely to slow in 2026.
Gross domestic product rose 2.9% year on year in the three months through September, the Ministry of Trade and Industry said Tuesday.
That beat economists’ forecasts for a 1.9% increase, though it marked a slowdown from a revised 4.5% expansion in the second quarter.
On a seasonally adjusted, quarter-on-quarter basis, the economy expanded by 1.3%, easing slightly from 1.5% in the previous quarter.
Manufacturing was the main drag on growth, flattening after a 5% expansion in the second quarter. The construction sector also softened, rising 3.1% year on year compared with 6.2% in the prior quarter.
“Growth was weighed down by output declines in the biomedical manufacturing and general manufacturing clusters, even as output in the other manufacturing clusters expanded,” MTI said in a statement.
The slowdown comes as Singapore’s central bank left its policy settings unchanged, maintaining its stance from July.
The Monetary Authority of Singapore said that GDP growth is expected to moderate as activity “normalises” in trade-related sectors.
Global investment in artificial intelligence is expected to support Singapore’s manufacturing sector, the central bank said, while construction and financial services should benefit from infrastructure spending and accommodative financial conditions.
“In 2026, GDP growth is projected to slow in line with external developments to a near-trend pace, such that the output gap narrows to around 0%,” MAS said in a statement.
Exports from Singapore recorded an 11.3% decline in non-oil domestic exports in August, the sharpest drop since March 2024.
Non-oil exports to Indonesia, the U.S. and China fell in August, but rose to the European Union, Taiwan and South Korea, government data showed.
Singapore’s exports to the United States dropped by 28.8% year on year in August, following a 42.8% fall in July.
—This is breaking news, please check back for updates.
At Open Compute Project Summit (OCP) 2025, we’re sharing details about the direction of next-generation network fabrics for our AI training clusters.
We’ve expanded our network hardware portfolio and are contributing new disaggregated network platforms to OCP.
We look forward to continued collaboration with OCP to open designs for racks, servers, storage boxes, and motherboards to benefit companies of all sizes across the industry.
At Meta, we believe that open hardware is a catalyst for innovation — especially as data center infrastructure increasingly supports new and emerging AI technologies. Open hardware plays a crucial role in enabling disaggregation, allowing us to break down traditional data center technologies into their core components. This approach empowers us to build systems that are more flexible, scalable, and efficient.
Since co-founding the Open Compute Project (OCP) in 2011, Meta has shared data center and component designs, and open-sourced our network operating system, FBOSS, to inspire new ideas both within our own operations and across the industry. These efforts have played an important role in making Meta’s data centers sustainable and efficient. Today, through OCP, we continue to advance open network technologies for the next generation of AI applications.
We’re announcing several new milestones for our data center networking:
The evolution of Disaggregated Scheduled Fabric (DSF) to support scale-out interconnect for large AI clusters that span entire data center buildings.
A new Non-Scheduled Fabric (NSF) architecture based entirely on shallow-buffer, disaggregated Ethernet switches that will support our largest AI clusters like Prometheus.
The addition of Minipack3N, based on NVIDIA’s Ethernet Spectrum-4 ASIC, to our portfolio of 51 Tbps OCP switches that use OCP’s SAI and Meta’s FBOSS software stack.
The launch of the Ethernet for Scale-Up Networking (ESUN) initiative, where Meta has worked with other large-scale operators and leading Ethernet vendors to advance using Ethernet for scale-up networking (specifically the high-performance interconnects required for next-generation AI accelerator architectures..
Dual-Stage DSF: Scaling Scheduled Fabrics for Larger AI Clusters
At last year’s OCP Global Summit we shared Disaggregated Scheduled Fabric (DSF), a VOQ-based system powered by the openOCP-SAI standard andFBOSS. The DSF fabric supports an open and standard Ethernet-based RoCE interface to endpoints and accelerators across several xPUs and NICs, including Meta’s MTIA as well as from several vendors.
Over the last year, we have evolved DSF to a 2-stage architecture, scaling to support a non-blocking fabric that interconnects up to 18,432 XPUs. These clusters are a fundamental building block for constructing AI clusters that span regions (and even multiple regions) in order to meet the increased capacity and performance demands of Meta’s AI workloads.
The new dual-stage DSF architecture supports non-blocking fabric, enabling interconnect between a larger number of GPUs in a cluster. At Meta, we’ve used it to build out clusters of 18k GPUs at the scale of entire data center buildings.
Non-Scheduled Fabrics (NSF) for Large AI Clusters
In parallel with the evolution of the DSF architecture, we have also devised a new architecture called the Non-Scheduled Fabric (NSF), with the following key features:
Based on shallow-buffer OCP Ethernet switches.
Delivers low round-trip latency.
Supports adaptive routing for effective load-balancing, ensuring optimal utilization and minimizing congestion.
Serves as foundational building block for Gigawatt-scale AI clusters like Prometheus.
NSF — Three-tier Non-Scheduled Fabrics for building scale AI clusters.
New OCP Switch Platforms for Next-Generation AI Fabrics
Last year, Meta introduced two new 51T Ethernet switches: Minipack3 (based on Broadcom Tomahawk5) and Cisco 8501 (based on Cisco Silicon One G200). These OCP switches offer 51.2 Tbps (64x OSFP ports), are power-efficient without the need for retimers, and run our large-scale network operating system, FBOSS. These platforms have served as the foundation for building our next-generation frontend and backend data center fabrics.
This year, we are introducing Minipack3N, a new 51T Ethernet switch that is based on the NVIDIA Spectrum-4 switching ASIC and leverages the same system design as Minipack3.
The Minipack3N, a 51.2 Tbps switch (designed by Meta and manufactured by Accton) based on the NVIDIA Spectrum-4 Ethernet switching ASIC.
Evolving FBOSS and SAI for DSF and NSF
Meta continues to embrace OCP-SAI as the foundation for onboarding new network fabrics, switch hardware platforms, and optical transceivers into FBOSS. Through close collaboration with vendors and the OCP community, we have evolved SAI to support advanced features and concepts, including DSF, NSF, and other enhanced routing schemes tailored for modern data center and AI workloads.
This open approach empowers developers and engineers worldwide to engage with cutting-edge hardware, contribute innovative software, and leverage these solutions for their own needs. By sharing advancements and fostering collaboration, we help accelerate progress across the industry, ensuring that open hardware and software remain at the heart of scalable, efficient, and future-ready data center infrastructure.
Optics: 2x400G FR4-LITE and 400G/2x400G DR4 Optics for 400G/800G Optical Interconnections
Last year, Meta introduced 2x400G FR4 BASE (3-km) optics, the primary solution supporting next-generation 51T platforms across both backend and frontend networks and DSFs. These optics have now been widely deployed throughout Meta’s data centers.
This year, we are expanding our portfolio with the launch of 2x400G FR4 LITE (500-m) optics. Developed as part of an efficiency initiative, FR4 LITE is optimized for the majority of intra–data center use cases, supporting fiber links up to 500 meters. This new variant is designed to accelerate optics cost reduction while maintaining robust performance for shorter-reach applications.
In addition, we are introducing the 400G DR4 OSFP-RHS optics — our first-generation DR4 solution for AI host-side NIC connectivity. Complementing this, the new 2x400G DR4 OSFP optics are being deployed on the switch side, providing connectivity from host to switch.
The 400G DR4 (left), 2x400G DR4 (center), and the 2x400G FR4 LITE (right).
Ethernet for Scale-Up Networking in OCP: Meta’s Industry Leadership
At Meta, we recognize that the future of AI and data center infrastructure depends on open, scalable, and interoperable networking solutions. As part of our ongoing commitment to open hardware and industry collaboration, Meta is a founding participant in the new Ethernet for Scale-Up Networking (ESUN) initiative, which launched within OCP at the 2025 OCP Global Summit.
What Is ESUN?
ESUN is a new workstream within the OCP Networking Project. It functions as an open technical forum where industry operators and leading vendors can collaborate to advance the use of Ethernet technology. The specific goal of ESUN is to leverage and adapt the mature Ethernet ecosystem to meet the unique, high-performance demands of the scale-up domain within modern AI systems.
ESUN is focused specifically on the network functionality aspect of scale-up systems. The workstream is designed to address the technical challenges related to how data traffic is managed and transmitted across network switches. This includes defining best practices and standards for:
Protocol headers
Error handling mechanisms
Achieving lossless data transfer across the network
The initiative brings together operators, vendors, and standards bodies to:
Collaborate on Ethernet solutions tailored for scale-up networking.
Focus on Ethernet framing and switching layers to ensure robust, lossless, and error-resilient multi-hop topologies.
Align with open standards by working closely with organizations like UEC and IEEE.
Meta’s Contributions to ESUN
Meta is proud to be among the initial group of OCP members driving ESUN, alongside industry leaders that includes: AMD, Arista, ARM, Broadcom, Cisco, HPE, Marvell, Meta, Microsoft, NVIDIA, OpenAI, and Oracle.
Our contributions include:
Technical leadership in defining the requirements for ESUN in AI clusters.
Open collaboration with vendors and standards bodies to ensure that solutions are interoperable and not tied to proprietary technologies.
Sharing best practices and lessons learned from deploying advanced Ethernet fabrics in Meta’s own data centers.,
An Industry Invitation: Join the Open Future
Driving progress in AI requires data center infrastructure that delivers more than just scale — it must also be flexible, efficient, and sustainable. At Meta, we envision a future where AI hardware systems are not only highly scalable, but also open and collaborative, enabling rapid innovation and adaptation to evolving workloads.
We invite engineers, developers, and industry partners to join us and the OCP community in shaping the next generation of networking hardware for AI. By working together and sharing ideas, we can accelerate the development of open, future-ready AI infrastructure that benefits the entire industry and supports the demands of tomorrow’s technologies.
Countries today face a fundamental challenge: how to grow their economies and meet development goals without repeating the planet-warming patterns of the past.
Historically, rapid economic growth has come at the cost of high greenhouse gas emissions. As the world works to secure a stable climate and safe future, decoupling the two is essential — particularly for emerging economies in places like southeast Asia, where energy demand and emissions are rising fast.
This challenge comes into sharp focus in Indonesia, which stands at a defining moment. Southeast Asia’s largest economy and the world’s fourth-most-populous country has two ambitious goals: to grow its GDP 8% per year by 2029 and reach net-zero emissions by 2060.
These objectives may seem to be at odds — and if the country continues on its current fossil-powered trajectory, they are. But this isn’t the only way.
New WRI research shows that Indonesia can achieve both climate and economic goals if it doubles down on clean energy and energy efficiency in the coming years. While the upfront investment is significant, the payoff is even greater: not just lower emissions, but also millions of new jobs, stronger energy security, cleaner air and better health.
These findings align with a growing body of research that shows climate action can grow economies while improving lives globally. Indonesia now has the opportunity to demonstrate that, with the right policies and decisive action, clean energy can be key to a more prosperous future.
Modeling a Path to Green Growth
At present, Indonesia’s energy needs are largely met by fossil fuels: 36% of its power came from coal and 26% from oil in 2023. Raising GDP 8% per year by 2029 would massively ramp up demand, particularly as the government prioritizes energy-intensive industries such as nickel, iron and steel. Meeting this growing demand with the country’s current carbon-intensive power mix risks rapidly driving up emissions.
In parallel to its economic goals, Indonesia has set out plans to shift away from fossil energy and toward clean power. Its latest Electricity Supply Business Plan (Rencana Usaha Penyediaan Tenaga Listrik, or RUPTL) aims to expand renewable power to 34.3% of the total power mix by 2034. The country is also part of a Just Energy Transition Partnership (JETP), which aims to mobilize $20 billion in international finance to support this transition. However, Indonesia is not on track to meet its clean energy goals and has even revised its renewable energy targets downward in recent years.
Our research sought to answer a key question: What if the country pursued its economic goals and an ambitious energy transition in tandem?
Understanding the socioeconomic implications of Indonesia’s net-zero energy transition
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Building on earlier modeling that informed Indonesia’s net-zero goal, we looked at what would happen if the country increased clean energy and energy efficiency as outlined under its JETP agreement. Laid out in the 2023 Comprehensive Investment and Policy Plan (CIPP), this pathway includes retiring two fossil fuel power plants by 2035; achieving 34% renewable energy by 2030; and implementing energy efficiency measures. (These could include measures like introducing minimum energy performance standards and labeling programs that promote energy-saving appliances, and improving motor-driven factory equipment and industrial machinery to reduce power consumption.)
Under this “JETP scenario,” new clean energy and improved energy efficiency would still deliver enough power to drive 8% GDP growth per year — while also reducing emissions and avoiding the environmental, health and fiscal costs that come with fossil fuel dependence.
With continued green energy investment, power sector emissions would peak in 2034 at about 324 million tonnes of carbon dioxide equivalent (MtCO2e) and drop to just 13.2 MtCO2e by 2050 — consistent with Indonesia’s goal of reaching net zero emissions by 2060. By contrast, under a business-as-usual scenario, power sector emissions would rise to 1.86 billion tonnes by 2050 — nearly six times what the sector emitted in 2022.
About the Data
Our analysis used an adaptation of the Indonesia Vision to 2045 (IV2045) model — developed under the country’s Low Carbon Development Initiative — to simulate high economic growth pathways either under existing energy systems or more efficient, low-carbon ones. The IV2045 model captures dynamic feedback loops between economic, environmental and social variables, helping decision-makers see both the full consequences of delaying clean energy investment and the long-term benefits of getting it right early.
Green Investments Can Power Jobs, Health and Energy Security
Curbing emissions is critical, but it’s far from the only benefit of shifting to clean energy. Our study finds that scaling up renewables in Indonesia can help the country achieve a bevy of economic and development goals.
Clean energy investments can drive big economic returns.
Scaling up renewable energy will require significant upfront investments in new infrastructure, such as wind turbines, solar farms and battery storage systems. However, the anticipated returns make this spend worthwhile. Our research shows that renewable energy investments in Indonesia can deliver a projected return of $1.41 billion for every $1 billion invested.
The more Indonesia invests in renewables, the more it will generate demand — and thereby additional investment — for them. This can create new value chains for the installation and maintenance of renewable energy systems, spurring significant job creation and contributing to GDP gains.
In addition, upfront deployment costs would be offset in the long term by the much lower operation and maintenance costs of renewable facilities compared to fossil fuel plants. And a greater supply of renewables can generate additional economic returns by keeping workers healthier and more productive through cleaner air.
International partners under Indonesia’s JETP will help provide early financial support for this infrastructure. But the total investment required to meet the country’s targets far exceeds the $20 billion committed under the partnership, meaning the country will need to secure significant additional funding in the near-term from the government, private sector and international sources.
Engineering students inspect rooftop solar panels in Bali, Indonesia. Investments in clean energy can help stimulate economies through the creation of new jobs and value chains. Photo by Pande Putu Hadi Wiguna/iStock
The transition can create millions of new jobs.
In 2024, Indonesia had 15.1 gigawatts of renewable energy installed. According to our model, JETP investments are projected to lead to an additional 52.2 GW of on-grid renewable power and transmission infrastructure by 2030. This massive build-out would create 383,000 new jobs in the energy sector this decade, including roles such as solar panel installers and wind turbine technicians.
Looking further ahead, the country could add almost 1 million total jobs in renewable energy construction and another 1.8 million in power generation by 2050. These would come from the scale up of not just wind and solar, but also hydropower, geothermal and nuclear power plants by 2034, as well as the introduction of green hydrogen in 2040.
While the net job gains are huge, this transition would also see 51,300 workers displaced from fossil fuel plants. Reskilling programs will be critical to help these workers transition into new, green job opportunities.
Shifting away from fossil fuels can bolster energy security.
Indonesia’s domestic oil production has been in decline since 1997, increasing the country’s reliance on imported oil to meet national energy demand. This is at odds with the country’s goal of becoming more energy independent, as imported fossil fuels are vulnerable to global price shocks and supply disruptions. It’s also expensive: In 2024 alone, Indonesia spent over US$36 billion on imported crude oil and natural gas.
Shifting to renewable energy would help lower this import dependence. In our JETP scenario, oil imports drop significantly as renewables scale up, saving 1.23 million barrels per day by 2050. In addition to limiting exposure to international market risks, this shift would free up public resources previously spent on oil imports and fossil fuel subsidies — funds that could be redirected to domestic energy infrastructure and other development priorities.
Moreover, increased reliance on clean electricity as opposed to fossil fuels could expedite the shift to electric transportation; a transition already well underway, with ambitions to electrify 90% of urban mass public transport by 2030 under the country’s National E-Mobility Plan. This would further reduce the need for imported oil.
Cleaner power means better health.
Fossil fuel power plants emit harmful pollutants, including fine particulate matter and nitrogen oxides. These contribute to air pollution-related illnesses, such as asthma, pneumonia, lung cancer and tuberculosis, often with fatal results. Air pollution accounted for close to 10% of all deaths in Indonesia in 2021, claiming over 222,000 lives. This places it among the five countries (alongside China, India, Pakistan and Nigeria) that together account for 60% of air pollution-related deaths globally. The problem is so severe in Jakarta that, in 2021, residents sued then-President Joko Widodo and other top officials over harmful air quality — and won.
Air pollution also takes a financial toll. Each case of acute respiratory illness in Indonesia carries an economic cost of roughly IDR 570,000 (about US$34), according to the national health insurance system. Between 2016 and 2021, this cost the country more than IDR 341 billion (about US$21 million) in total. Meanwhile, lost workdays from illnesses reduce overall productivity.
Renewable energy deployment would significantly reduce dangerous air pollution, lowering healthcare costs and increasing workforce productivity. Our model shows that meeting Indonesia’s clean energy goals could save an estimated 62,000 lives per year, compared with business as usual.
Turning Projections into Reality
Taken together, these wide-ranging benefits show that decisive climate action is not just about avoiding risks — it is about seizing opportunities to grow sustainably and improve people’s lives. But urgency is paramount. Indonesia and other countries need to move swiftly to scale up clean energy and energy efficiency and avoid locking in costly, polluting fossil fuel infrastructure for decades to come.
The first step is raising ambition. Our analysis, based on interventions outlined in the 2023 CIPP, shows that Indonesia needs 63.5 gigawatts of renewable capacity by 2030 and 200 gigawatts by 2040 to meet its GDP targets via clean power. By contrast, the government’s Electricity Supply Business Plan aims for only 18.6 gigawatts by 2030 and 75 by 2040. To turn its growth and climate ambitions into reality, the government must more than double its clean energy targets.
Investing early in energy efficiency can immediately address short-term energy demand and emissions while the country works toward longer-term decarbonization. Near-term measures can include building new energy distribution infrastructure, like transmission lines or microgrids connecting Indonesia’s main islands. It can also include updating existing systems; for example, by switching to more efficient LED-based lighting systems and retrofitting windows to reduce air conditioning demand.
The biggest thrust, however, must come from rapidly expanding renewable energy and slashing reliance on fossil fuels. This will require mobilizing unprecedented clean energy investment from both the public and private sectors on top of JETP financing. It will also take significant policy change, such as cutting fossil fuel subsidies; implementing cross-sector efficiency standards to reduce energy intensity in manufacturing, transport and buildings; and upgrading grid infrastructure to integrate variable renewable energy sources.
Lighting the Way Ahead
While our study focuses on Indonesia, the implications are global. Many developing and emerging economies are at a similar crossroads, working to expand energy access and grow rapidly without exacerbating climate risks — and to ensure that the transition leaves no one behind.
This research offers compelling evidence that a clean energy transition is not an obstacle to growth, but a catalyst for it. By aligning ambitious growth targets with decisive clean energy strategies, countries can take the first step toward unlocking sustainable prosperity.
While developments in the electric motorcycle space would not normally catch our eye, we were intrigued by Zapp EV’s press release announcing a new factory because of the company’s production strategy: a “microfactory” in a Bangkok Free Trade Zone industrial park. Zapp plans to create 20,000 made-to-order and personalized units per year in a 12,000-square-foot (1,100-square-meter) space. A typical motorcycle factory’s footprint is often an order of magnitude larger, with major facilities often at least 500,000 square feet. While Zapp faces its own set of challenges and the company’s success is uncertain, its progress raises a broader question: Are we in a back to local moment, with new automation allowing for much smaller factories making more bespoke products?
New technologies are enabling smaller-scale and more customized production. With high levels of automation, factories can be profitable at a much smaller scale and can be located much closer to the customer than previously feasible. While not all early ventures will succeed, second movers may find greater success. A growing number of microfactories show us that the concept is increasingly viable even if further refinement is necessary.
Companies across a wide swath of industries have opened microfactories, including:
Food and beverage (Relocalize)
1,200-square-foot autonomous units to make and package ice for grocery stores, with plans to expand to beverages
Value proposition: reduced logistics cost and sustainability
Apparel (Rodinia Generation):
2,150-square-foot highly automated microfactory capable of producing around 80% of all clothing categories
Value proposition: 48-hour turnaround, mitigation of global trade risks and costs, and enhanced sustainability
Semiconductors (Nanotronics Cubefabs):
Facilities as small as 25,000 square feet with a capital requirement starting around $30 million
Value proposition: resiliency (countries or OEMs could own their own fabs) and scalable modular design
Motorcycles (Zapp EV):
12,000-square-foot facilities producing around 20,000 vehicles annually
Value proposition: customization, direct-to-consumer delivery, and premium quality
(Note: Not yet profitable; a similar effort in EV vans by Arrival folded despite early hype.)
Why now?
Significant shifts in technology and society suggest microfactories’ moment may be near. Four factors in particular help set the stage:
Manufacturing technology: We’ve seen a shift from large, capital-intensive automation technologies toward more flexible automation. Emerging tools such as AI-driven robotics (and potentially 3D printing) lower scale thresholds significantly, and they’re rapidly improving in quality and declining in cost.
Sales and marketing approaches: Precision online advertising and AI-enabled customization help companies target niche segments and build personalized ads for personalized products.
Unmet consumer needs: Microfactories may better serve demand for localization, personalization, and speed. Experiences that were formerly only for the wealthy—such as tailored clothing or food prepared based on a custom nutrition plan—may become more affordable. Even the smallest customer segments, which are stuck with one-size-fits-all offerings today, could become commercially viable with a specialized offering.
Regulatory pressure: Rising protectionism (tariffs, subsidies, and an array of nontariff barriers) and sustainability mandates all make logistics more costly and favor local production.
How could a back to local moment play out?
The US beer industry offers a parallel transformation—from dominance by macro breweries to a surge of craft breweries. While craft brewing has now become a mature industry, even suffering some recent declines, it is still a remarkable insurgent story over the last 20 years. From 1998 to 2008, the number of breweries held steady at around 1,500. Since then, 8,500 new breweries have launched, giving consumers greater choice and more local variety (see Figure 1). Craft beer’s market share grew from less than 3% in 1998 to 13% by 2024. The same forces that could drive microfactory expansion drove this growth:
Manufacturing technology: more affordable and automated brewing equipment
Sales and marketing approaches: Internet-enabled brand building and localized targeting
Unmet consumer needs: flavor variety, “buy local” preferences, and new experiences (e.g., brewpubs)
Regulatory pressure: legalization of homebrewing in 1979 and the subsequent deregulation at the state level
Craft beer has exploded in the US
Source: Brewers Association
Widespread, cost-competitive, and highly localized production has the potential to reshape numerous industries. Imagine custom-fit clothing priced for the middle class, mainstream cars with the personalization of a gaming PC, or even individually designed protein bars. While many of these products are luxuries currently reserved for the wealthy, emerging technologies may soon make them accessible to a much broader market.
These technological shifts are arriving alongside broader systemic changes that favor decentralization. As pressure mounts on the global free-trade system, markets are fragmenting. Capital-heavy business models may face headwinds as an era marked by cheap and abundant financing comes to an end. In contrast, smaller, modular manufacturing setups offer greater agility. Companies will be able to move with talent pools, respond to local demand, and avoid trade barriers. That strategy stands in contrast to one of anchoring to a single, large location that requires a material portion of global demand to be profitable.
What industries are at greater risk of disruption?
Microfactories could reshape manufacturing footprints in many industries, but that does not necessarily equate to high risks for incumbents. Some incumbents may successfully adapt and even thrive as they embrace the ability to provide more personalization and local production under existing brand umbrellas. Others may cede share to agile new entrants, as seen in the craft beer industry. The way in which customers value brand recognition will be one key factor in the risk level to incumbents.
Bragging rights from universal recognition: Brands that enjoy broad recognition combined with some level of exclusivity will be more likely to emerge strong from this transition (i.e., brands that consumers want everyone to know they’re buying).
Few bragging rights or bragging rights from niche appeal: Industries in which brands may be widely recognized but lack prestige, or where brand value comes from limited recognition (e.g., that small-batch beer only a few beer connoisseurs know about).
What business leaders should be asking today:
Where do consumers most value customization and localization, and how can we best serve that?
How appealing are niche or generic alternatives in our industry?
Are our long-term capex and manufacturing footprint plans robust in a world in which microfactories might have a competitive advantage?
What does a blank-sheet view of a small-scale, localized, highly disruptive business model look like five years from now in my industry?
TOKYO and CAMBRIDGE, Mass., Oct. 13, 2025 /PRNewswire/ — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that LEQEMBI® IQLIK™, a subcutaneous autoinjector formulation of lecanemab (generic name), for the treatment of Alzheimer’s disease (AD) has been selected by TIME as one of the “Best Inventions of 2025” in the Medical and Healthcare category.
LEQEMBI IQLIK product photo
TIME’s annual list of the Best Inventions features 300 extraordinary innovations changing lives. To compile the 2025 list, TIME solicited nominations from TIME editors and correspondents around the world, and through an online application process, paying special attention to growing fields such as health care and AI. TIME then evaluated each contender on a number of key factors, including originality, efficacy, ambition, and impact. For more information, please visit time.com/collections/best-inventions-2025/.
LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and their care partners continue to slow disease progression following the 18-month initial treatment period. The treatment was approved in the U.S. in August 2025 and launched on October 6. LEQEMBI IQLIK offers patients and their care partners the potential to shorten administration time (approximate injection time of 15 seconds), providing an option to continue treatment without having to worry about visiting an infusion center. Moreover, it has the potential to reduce healthcare resources associated with intravenous (IV) maintenance dosing, such as preparation for infusion and nurse monitoring, while increasing infusion capacity for new eligible patients to begin initiation treatment and streamlining the overall AD treatment pathway.
LEQEMBI, recognized as one of TIME’s “Best Inventions of 2023,” is the first approved anti-amyloid treatment for AD shown to slow disease progression and cognitive and functional decline in adults with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). LEQEMBI has been approved in 50 countries and is under regulatory review in 10 countries. In early September, Eisai initiated a rolling Supplemental Biologics License Application (sBLA) to the U.S. FDA for LEQEMBI IQLIK as a subcutaneous starting dose for the treatment of early AD under Fast Track Status.
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
INDICATION LEQEMBI® is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI.
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Apolipoprotein E ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 homozygotes (~15% of patients with AD) treated with this class of medications have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA.
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Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI.
CONTRAINDICATION Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.
WARNINGS AND PRECAUTIONS
AMYLOID-RELATED IMAGING ABNORMALITIES Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.
Incidence of ARIA Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.
Incidence of ICH ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.
Risk Factors of ARIA and ICH ApoE ε4 Carrier Status Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.
Radiographic Findings of CAA Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE ε4 allele is also associated with CAA.
The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.
Concomitant Antithrombotic or Thrombolytic Medication In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.
Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.
Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.
Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.
Radiographic Severity With LEQEMBI Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).
Monitoring and Dose Management Guidelines Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.
HYPERSENSITIVITY REACTIONS Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.
INFUSION-RELATED REACTIONS (IRRs) IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.
IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.
ADVERSE REACTIONS
The most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%)
Safety profile of LEQEMBI IQLIK for maintenance treatment was similar to LEQEMBI infusion. Patients who received LEQEMBI IQLIK experienced localized and systemic (less frequent) injection-related reactions (mild to moderate in severity)
LEQEMBI (lecanemab-irmb) is available:
Intravenous infusion: 100 mg/mL
Subcutaneous injection: 200 mg/mL
Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.
MEDIA CONTACTS
Eisai Co., Ltd.
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Eisai Inc. (U.S.)
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Biogen Inc.
Madeleine Shin
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[email protected]
INVESTOR CONTACTS
Eisai Co., Ltd.
Investor Relations Department
TEL: +81 (0) 3-3817-5122
Biogen Inc.
Tim Power
+ 1-781-464-2442
[email protected]
Notes to Editors
About lecanemab (generic name, brand name: LEQEMBI®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
Lecanemab has been approved in 50 countries and is under regulatory review in 10 countries. The supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the U.S.in January 2025 and China in September 2025, and applications have been filed in 5 countries and regions.
LEQEMBI’s approvals in these countries was based on Phase 3 data from Eisai’s, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P<0.001). In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted a statistically significant benefit of 37% compared to placebo. The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the lecanemab group and −5.5 in the placebo group (difference, 2.0; 95% CI, 1.2 to 2.8; P<0.001). The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.
The subcutaneous maintenance dosing approval is based on LEQEMBI subcutaneous (SC) sub-studies of the Phase 3 Clarity AD open-label extension (OLE) trial in individuals with early AD which evaluated a range of subcutaneous doses. Data shows that transitioning to the weekly LEQEMBI IQLIKTM autoinjector after 18 months of the initiation dose (10 mg/kg IV every two weeks) maintains clinical and biomarker benefits comparable to continued IV dosing. The safety of LEQEMBI IQLIK autoinjector was studied in over 600 patients at a range of doses as part of the Clarity AD OLE. Across all subcutaneous doses, the safety profile was similar to that of the IV maintenance treatment with one key difference: systemic reactions were much less common with subcutaneous dosing—less than 1% compared to approximately 26% with IV infusions. ARIA rates in patients who received a weekly 360 mg subcutaneous maintenance dose were similar to ARIA rates reported in patients who continued with the IV dose after 18 months and are similar to the background rates of ARIA in patients without treatment.
Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai, and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.
About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
About Eisai Co., Ltd. Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.
About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the potential to streamline the Alzheimer’s disease treatment pathway; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission.
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