Exelead, Inc.

Merck KGaA plans to invest more than $321 million (€300 million) to build a new 'Advanced Research Center' at its global headquarters in Darmstadt, Germany. The building — which will accommodate around 550 employees upon its estimated completion in early 2027 — will enable research on solutions for manufacturing antibodies, mRNA applications and additional products required for biotech production. The drugmaker is shooting for gold certification from the German Sustainable Building Council for the new 18,000-square-meter facility, planning "almost" carbon-neutral research operations. Energy supply will be based on photovoltaics, geothermal energy and air-source heat pumps. The new building is part of a broader investment initiative at the Darmstadt site that will reach $1.6 billion by 2025. Merck KGaA specifically highlighted the importance of mRNA research in the research center announcement, noting that there are more than 740 clinical trials in the mRNA space currently in progress globally.The drugmaker has made an effort to boost its mRNA capabilities through acquisitions, paying $780 million to pick up CDMO Exelead in 2022. Headquartered in Indianapolis, Exelead specializes in complex sterile injectable formulations like lipid nanoparticle-based technologies, a key component in mRNA treatments. In 2021, via its life sciences arm, MilliporeSigma, Merck KGaA picked up AmpTec, a Germany-based, mRNA CDMO.

New sites at Darmstadt and Hamburg complement company's global integrated mRNA service network with pre-clinical to commercial capabilities Company's Millipore® CTDMO Services now encompass all key stages of mRNA technologies, lipids, lipid nanoparticles (LNP) and fill/finish, including key products and biosafety testing Expansion part of company's ongoing € 1 billion investment plan to advance mRNA technologies BURLINGTON, Mass., Sept. 26, 2023 /PRNewswire/ -- MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, is the first CTDMO (contract testing, development and manufacturing organization) to offer integrated services for all critical stages of mRNA development, manufacturing, and commercialization, including products and testing. The company today opened two new GMP-grade mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. Continue Reading MilliporeSigma’s new large scale mRNA drug substance manufacturing facility at the company’s headquarters in Darmstadt, Germany. This new GMP facility is equipped with a scalable and flexible manufacturing process platform, enabling highest quality mRNA for clinical and commercial applications. "mRNA has emerged as the breakthrough technology of this century, providing great promise to not only treat, but potentially cure, a wide array of diseases such as cancer, heart disease, and muscular dystrophy," said Dirk Lange, Head of Life Science Services, Life Science business sector of Merck KGaA, Darmstadt, Germany. "We are now the first CTDMO to streamline the entire mRNA process for our clients." The new sites are part of the company's ongoing € 1 billion investment to advance mRNA technologies and build its global mRNA network and capabilities, as well as through acquisitions such as AmpTec and Exelead. The € 28 million investment into the new GMP mRNA drug substance manufacturing sites at Darmstadt and Hamburg adds a total of 75 new jobs, providing clients mRNA services at all scales and applications from pre-clinical to commercial. This includes analytical development and biosafety testing specifically designed for mRNA technologies. MilliporeSigma also offers differentiated PCR-based technology for clinical and commercial mRNA manufacturing, providing clients with high-quality mRNA. With this integrated offering, the company can significantly decrease complexities through streamlined and harmonized processes and enhance clients' speed-to-market. Since the 1990s, the Life Science business of Merck KGaA, Darmstadt, Germany has collaborated with researchers to ensure they have the critical components and raw materials needed to explore mRNA's potential. Its unique combination of mRNA expertise, technologies, regulatory knowledge, and product portfolios streamlines mRNA manufacturing and testing. The company's mRNA, custom and portfolio lipids, LNP and fill/finish CTDMO services are offered throughout its global network of sites in Schaffhausen, Switzerland; Indianapolis, Indiana, USA and Darmstadt and Hamburg, Germany. "As a researcher working on finding cures with mRNA technology and as a believer in its curative promise, collaborating with the Life Science business of Merck KGaA, Darmstadt, Germany has helped to advance my research in finding a cure by leveraging mRNA's promise for muscular dystrophy," said Dr. Simone Spuler, head of the Myology Lab at the Experimental and Clinical Research Center (ECRC), a joint institution of the Max Delbrück Center for Molecular Medicine in the Helmholtz Association and Charité - Universitätsmedizin Berlin. The company's Millipore® CTDMO Services also provide pre-clinical through commercial capabilities for monoclonal antibodies and recombinant proteins (mAb and r-proteins), viral vectors (VV), small molecules and high-potent active pharmaceutical ingredients (HPAPI), antibody-drug conjugates (ADCs) as well as integrated analytical development, biosafety testing, and product characterization. Millipore® CTDMO Services are part of the Life Science Services business unit, which together with the Process Solutions business is one of Merck KGaA, Darmstadt, Germany's "Big 3" growth drivers. Merck KGaA, Darmstadt, Germany aims to increase its Group sales to approximately € 25 billion by 2025. Around 80% of the planned sales growth is to come from the "Big 3" growth drivers. About the Life Science business of Merck KGaA, Darmstadt, Germany The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 28,000 employees and more than 55 total manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. More than 64,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck KGaA, Darmstadt, Germany, generated sales of € 22.2 billion in 66 countries. The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck KGaA, Darmstadt, Germany, visit . Follow MilliporeSigma on  Twitter @MilliporeSigma, on  Facebook @MilliporeSigma and on  LinkedIn. All Merck KGaA, Darmstadt, Germany news releases are distributed by email at the same time they become available on the EMD Group website. In case you are a resident of the U.S. or Canada please go to to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service. SOURCE MilliporeSigma

Financial results of Q1 2023 Group net sales rise by 1.8% to € 5.3 billion New Healthcare products major growth drivers EBITDA pre down −2.6% to € 1.6 billion Medium-term structural growth drivers intact Forecast for fiscal 2023 Net sales: organic growth of 1% to 4% Net sales excluding Covid-19-related business: organic increase of 4% to 7% EBITDA pre: organic decline of −5% to stable at 0% Negative foreign exchange effects on net sales and EBITDA pre of − 5% to − 2% expected Darmstadt, Germany, May 11, 2023 – Merck KGaA, Darmstadt, Germany, a leading science and technology company, generated net sales of € 5.3 billion in the first quarter of 2023. This corresponds to an increase of 1.8% over the year-earlier quarter (organically 0.8%). Sales growth was in particular attributable to Healthcare, which delivered significant increases in its business with new medicines, one of the company’s “Big 3” growth drivers. Life Science, in particular the Science & Lab Solutions business unit, also contributed positively to sales growth. EBITDA pre decreased by −2.6% (organically −1.7%) to € 1.6 billion. The main reasons for this were the decline in the Display Solutions business as well as the significant decrease in earnings contributions from Covid-19-related sales. “2023 will be a transition year for us. As expected, our Life Science and Electronics businesses were confronted with a difficult market environment in the first quarter. The weaker market for Display and Semiconductor Solutions as well as the continued decline in Covid-19-related sales weighed on our business performance,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “At the same time, Healthcare benefited from the growth of new products. This proves the resilience of our diversified, multi-industry portfolio. Our structural growth drivers remain intact. We are confident that we will be able to achieve our medium-term target of 25 billion euros in sales by 2025.” In the first quarter of 2023, the company continued to drive key growth and strategic initiatives. A team from the Life Science business sector helped to further drive digitalization by publishing its code library together with partner Palantir in March. It is the first-ever customer-developed, open-source library for Palantir Foundry that provides consistent digital blueprints to boost productivity and quality for developers. In March, the Group strengthened its Oncology franchise and terminated the alliance agreement with Pfizer on Bavencio. Effective June 30, 2023, the company will regain the exclusive worldwide rights to develop, manufacture and commercialize Bavencio. As a result, Merck KGaA, Darmstadt, Germany, expects a significant increase in profit from sales of Bavencio. In the Electronics business sector, construction work for a new production facility for semiconductor materials began in Kaohsiung, Taiwan, in February. Lower customer utilization in Display Solutions and continued decline in Covid-19-related demand impact earnings Group net sales rose organically by 0.8% to € 5,293 million in the first quarter of 2023. Foreign exchange effects, especially from the development of the U.S. dollar, contributed 0.8% to the growth in sales. Portfolio effects were responsible for 0.2% and were mainly attributable to the acquisitions of the biopharmaceutical contract development and manufacturing organization Exelead, Inc., USA, as well as the chemical business of Mecaro Co. Ltd., a Korea-based supplier to the semiconductor industry. EBITDA pre fell by −2.6% to € 1,587 million. Organically, the decline amounted to −1.7%. Among other things, this was due to lower customer utilization in Display Solutions as well as the significant decrease in earnings contributions from Covid-19-related sales. In addition, one-time effects such as royalty and license income had a positive impact on EBITDA pre in the year-earlier quarter. EBITDA pre was adversely affected by foreign exchange effects of −0.5% and a portfolio impact of −0.4%. The EBITDA pre margin was 30.0% and EPS pre amounted to € 2.36. Life Science: Robust growth in core business compensates decline in Covid-19-related demand In the first quarter of 2023, the Life Science business sector generated net sales of € 2,487 million. The robust growth in the core business compensated for the expected, sharp decline in Covid-19-related sales. Compared with the year-earlier quarter, this represents an increase of 1.7%, comprising 0.6% from organic growth, 0.9% from foreign exchange effects and 0.3% from acquisitions. The Process Solutions (−4.1%) and Life Science Services (−7.2%) business units saw organic sales declines due to the significant decrease in Covid-19-related demand. By contrast, the net sales of Science & Lab Solutions increased organically by 5.9%. This business unit offers products and services to support research activities. With net sales of € 1,276 million, it accounted for 51% of Life Science sales in the first quarter. EBITDA pre of Life Science decreased by −2.9% to € 901 million compared with the first quarter of 2022. This reflected the lower share of Covid-19-related sales and earnings as well as higher investments in growth segments such as novel modalities, among other things. Organically, the decline amounted to −1.4%. Foreign exchange was responsible for −1.0%, and portfolio effects for −0.5%. The EBITDA pre margin of Life Science was 36.2%. Healthcare: Very good first quarter driven by growth of recent launches In the first quarter of 2023, sales of the Healthcare business sector increased by 6.2% to € 1,905 million. Organic growth was 5.3%. Foreign exchange had a positive effect of 0.8% on sales growth. The key growth drivers were once again new Healthcare products: The immuno-oncology drug Bavencio generated an organic sales increase of 30.6%. Sales of Mavenclad for the treatment of relapsing multiple sclerosis grew organically by 23.0%. Both the Fertility and the Cardiovascular, Metabolism & Endocrinology franchises saw organic sales growth of their portfolio products. EBITDA pre of Healthcare rose by 11.4% to € 590 million in the first quarter of 2023. Organic growth was 10.5%, supported by positive foreign exchange effects of 0.9%. The EBITDA pre margin of the business sector came in at 30.9%. Electronics: Semiconductor Solutions grows slightly despite decline in the semiconductor materials market; continued weakness of Liquid Crystals In the Electronics business sector, sales decreased by −5.9% to € 901 million in the first quarter of 2023. The organic decline of −7.1% was mitigated by positive foreign exchange effects of 0.8% as well as a portfolio effect of 0.3%. In a semiconductor market that slowed as expected, Semiconductor Solutions generated an organic sales increase of 2.0%, well above market. This business unit accounted for around two thirds of the sales of Electronics. By contrast, the Display Solutions (−28.1%) and Surface Solutions (−4.9%) business units saw organic sales declines. In Display Solutions, this was due in particular to continued low demand for liquid crystals. EBITDA pre of Electronics decreased by −18.0% to € 237 million compared with the year-earlier quarter. The organic decline amounted to −19.8%. The further price decline in the Liquid Crystals business, the weaker market environment in Semiconductor Solutions as well as cost inflation had negative impacts. Foreign exchange effects of 2.3% made a positive contribution to the development of EBITDA pre, whereas the acquisition of the chemical business of Mecaro had a negative impact of −0.4 % on this figure. The EBITDA pre margin of Electronics was 26.4%. Forecast for fiscal 2023: Healthcare remains a growth driver; negative impacts from softer market environment in Electronics, continued decline of Covid-19-related demand and high cost level The Group is specifying the forecast for fiscal 2023. For sales, the company expects growth especially from new Healthcare products and the Life Science core business. Negative impacts are likely from declining Covid-19-related sales, the slowing Display Solutions business and an even more pronounced weakening of the semiconductor materials market. This market is expected to recover in the second half of 2023, but at a later point and from a lower base than previously assumed. For EBITDA pre, the company expects the high level of costs due to inflation to weigh on earnings of all business sectors, in particular in Life Science and Electronics. EBITDA pre of Healthcare is forecast to increase organically, mainly thanks to the expected strong business performance. In summary, the Group expects for fiscal 2023: Net sales of between € 21.2 billion and € 22.7 billion (2022: € 22.2 billion) Thereof: organic growth of 1% to 4% Excluding Covid-19-related sales: organic sales growth of 4% to 7% Sales from Covid-19-related demand: around € 250 million Negative foreign exchange effects of −5% to −2% EBITDA pre of € 6.1 billion to € 6.7 billion (2022: € 6.8 billion) Organic decline of −5% to stable at 0% Negative foreign exchange effects of −5% to −2% EPS pre of € 8.80 to € 9.90, based on an underlying tax rate of 22% Overview of the key figures for Q1 2023 Group Key figures € million Q1 2023 Q1 2022 Change Net sales 5,293 5,198 1.8% Operating result (EBIT) 1 1,035 1,173 -11.8% Margin (% of net sales) 1 19.6% 22.6% EBITDA 2 1,491 1,603 -7.0% Margin (% of net sales) 1 28.2% 30.8% EBITDA pre 1 1,587 1,629 -2.6% Margin (% of net sales) 1 30.0% 31.3% Profit after tax 800 884 -9.5% Earnings per share (in €) 1.83 2.02 -9.4% Earnings per share pre (€) 1 2.36 2.41 -2.1% Operating cash flow 853 840 1.5% Net financial debt 3 8,992 8,328 8.0% Number of employees 4 64,011 61,517 4.1% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 3 Figures for the reporting period ending on March 31, 2023, prior-year figures as of December 31, 2022. 4 Figures for the reporting period ending on March 31, 2023, prior-year figures as of March 31, 2022. Prior-year figures have been adjusted. This figure refers to all employees at sites of fully consolidated entities. Life Science Net sales by business unit € million Q1 2023 Share Organic growth 1 Exchange rate effects Acquisitions/ divestments Total change Q1 2022 2 Share Science & Lab Solutions 1,276 51% 5.9% 0.5% – 6.5% 1,199 49% Process Solutions 1,022 41% -4.1% 1.1% 0.1% -3.0% 1,053 43% Life Science Services 188 8% -7.2% 1.7% 2.9% -2.6% 193 8% Life Science 2,487 100% 0.6% 0.9% 0.3% 1.7% 2,445 100% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Previous year’s figures have been adjusted owing to an internal realignment. Healthcare Net sales by major product lines/products € million Q1 2023 Share Organic growth 1 Exchange rate effects Total change Q1 2022 Share Oncology 433 23% 14.7% -0.4% 14.3% 379 21% thereof: Erbitux ® 250 13% 3.7% -0.6% 3.1% 242 13% thereof: Bavencio ® 167 9% 30.6% – 30.7% 128 7% Neurology & Immunology 390 20% -2.0% 1.9% -0.1% 391 22% thereof: Rebif ® 154 8% -25.4% 1.6% -23.8% 201 11% thereof: Mavenclad ® 237 12% 23.0% 2.2% 25.2% 189 11% Fertility 366 19% 6.7% 0.6% 7.3% 341 19% thereof: Gonal-f ® 197 10% -2.1% 0.7% -1.4% 200 11% Cardiovascular, Metabolism and Endocrinology (CM&E) 677 36% 3.0% 0.8% 3.8% 652 36% thereof: Glucophage ® 218 11% -0.1% 0.2% 0.1% 218 12% thereof: Concor ® 142 7% 0.8% 2.0% 2.9% 138 8% thereof: Euthyrox ® 130 7% 0.4% 0.5% 0.9% 128 7% thereof: Saizen ® 76 4% 25.1% -0.1% 25.0% 61 3% Other 38 2% 32 2% Healthcare 1,905 100% 5.3% 0.8% 6.2% 1,795 100% 1 Not defined by International Financial Reporting Standards (IFRS). Electronics Net sales by business unit € million Q1 2023 Share Organic growth 1 Exchange rate effects Acquisitions/ divestments Total change Q1 2022 Share Semiconductor Solutions 604 67% 2.0% 1.6% 0.5% 4.1% 581 61% Display Solutions 187 21% -28.1% -0.4% – -28.5% 262 27% Surface Solutions 109 12% -4.9% -0.2% – -5.1% 115 12% Electronics 901 100% -7.1% 0.8% 0.3% -5.9% 957 100% 1 Not defined by International Financial Reporting Standards (IFRS). Notes to editors: The press conference for media representatives will take place at 9:30 a.m. (CEST). The respective presentation and further information for journalists, including a digital press kit , can be found here The quarterly statement can be found here Twitter and LinkedIn Photos and images can be found here Stock symbols Reuters: MRCG, Bloomberg : MRK GY, Dow Jones : MRK.DE Frankfurt Stock Exchange : ISIN : DE 000 659 9905 – WKN : 659 990 All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to www.emdgroup.com/subscribe to register for your online, change your selection or discontinue this service. About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 64,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck KGaA, Darmstadt, Germany, generated sales of € 22.2 billion in 66 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.