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Hemostasis

Giovanni Russi

Giovanni Russi

COO, Hemostasis and Acute Care Diagnostics

As we reflect on 2020, the first word that comes to mind is resiliency. Nowhere was this more evident than in the clinicians, laboratorians, and healthcare systems we serve. And with them, throughout our entire organization, from manufacturing and logistics to service and support, Werfen, too, has persevered. We have all faced—and overcome—tremendous challenges, while continuing to pursue the highest quality patient care, every day.

The global pandemic elevated the importance of specialized diagnostic solutions as never before, with Hemostasis, Blood Gas and Viscoelastic testing, key for COVID-19 management. Automation, ease of use, quality management and connectivity became even more essential for healthcare systems as they responded to organizational and workflow changes. And, the reliability of healthcare manufacturers to ensure minimal disruption to the supply chain was vital.

Fortunately, we were able to meet the challenges of the pandemic head on. First and foremost, we successfully maintained operations for all functions, addressing the increased demand for products and services from our customers worldwide, with virtually no interruption. More than 450 million patient samples were tested on our Hemostasis and Acute Care Diagnostic systems in hospitals and labs around the world, and we consistently met quality and reliability goals for more than 65,000 Hemostasis and Acute Care Diagnostic systems in clinical use.

In addition to maintaining continuity for our customers, we initiated or expanded the commercial release of key new products, including the GEM® Premier™, ChemSTAT™ and GEM Hemochron™ 100 systems. And, we received de novo marketing authorization from the US Food and Drug Administration (FDA) for the HemosIL® Liquid Anti-Xa test kit to measure apixaban.

2020 was also a record year for shipments of GEM Premier 5000, ACL TOP® Family 50 Series and ROTEM® systems, as well as our HemoCell™ Specialized Automation workcell. Adoption of our data management solutions, G GEMweb® Plus Custom Connectivity and HemoHub™ Intelligent Data Manager set new records.

Our commitment to, and investment in, R&D continued, increasing resources by more than 10% and entering feasibility and/or proceeding with the development of next-generation systems and parameters.

A transformative year for our training, education, and support, we engaged in myriad virtual initiatives, including trainings, demos, educational webinars, congresses and events. We expanded our digital educational and training platform, Werfen Academy, for healthcare providers around the world; and, we leveraged it to facilitate customer operator training. We also increased our emphasis on remote support through ProDx™ Remote Support Suite systems, and other connectivity tools.

Though uncertainty remains high in 2021, we will continue to focus on innovation, quality management, connectivity, advanced service and support and personnel training. Our diversified portfolio of Hemostasis and Acute Care Diagnostics will be critical, for COVID-19 management and beyond, as clinicians and their patients return to routine care.

Through it all, as always, we prioritize continuous quality improvement and innovation, to address the needs of our customers and their patients. We appreciate the trust placed in us and remain dedicated to providing the very best specialized diagnostics.

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Industry-leading systems, reagents and data management solutions.

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Full commercial release of HemosIL AcuStar ADAMTS13 Activity assay and launch of Ac Accutrak™ 2.0 quality control program.

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De novo approval from the US FDA for the HemosIL Liquid Anti-Xa test kit to measure apixaban and release of HemosIL Fibrin Monomer in Japan.

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Record number of HemoCell workcell and HemoHub Intelligent Data Management placements and record sales for HemosIL D-Dimer, HIT and Anti-Xa assays.

Acute Care Diagnostics

Our commitment to, and investment in, R&D continued, increasing resources by more than 10% and entering feasibility and/or proceeding with the development of next-generation systems and parameters.

A transformative year for our training, education, and support, we engaged in myriad virtual initiatives, including trainings, demos, educational webinars, congresses and events. We expanded our digital educational and training platform, Werfen Academy, for healthcare providers around the world; and, we leveraged it to facilitate customer operator training. We also increased our emphasis on remote support through ProDx, and other connectivity tools.

Though uncertainty remains high in 2021, we will continue to focus on innovation, quality management, connectivity, advanced service and support and personnel training. Our diversified portfolio of Hemostasis and Acute Care Diagnostics will be critical, for COVID-19 management and beyond, as clinicians and their patients return to routine care.

Through it all, as always, we prioritize continuous quality improvement and innovation, to address the needs of our customers and their patients. We appreciate the trust placed in us and remain dedicated to providing the very best specialized diagnostics.

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Thousands of hospitals rely on our Acute Care Diagnostics portfolio.

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Acute Care Diagnostics growth driven by GEM Premier 5000 systems; record number of placements of GEM Premier instruments worldwide.

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Full commercial release of GEM Premier ChemSTAT system in Europe and the US, and controlled distribution of GEM Hemochron 100 in the UK.

Autoimmunity

Roger Ingles

Roger Ingles

COO, Autoimmunity

In 2020, the Autoimmunity business line was impacted by the COVID-19 pandemic. Traditionally, autoimmune disease testing is not considered urgent and accurately diagnosing patients with autoimmunity typically can take several months, or even years. Many patients had to postpone their visits to physicians for several months, until it was safe for them to return to hospitals and care centers.

We managed these unusual times by continuing to deliver products to customers, and, managing the continued activity in R&D to complete the projects on time. Another important area of activity was leveraging new means of customer outreach. The virtual environment, made possible thanks to IT, allowed us to connect and build even stronger teams internally and externally. We held various training sessions for our staff and affiliates worldwide to strengthen our knowledge base of autoimmunity to better position the business line for the future.

Other virtual activities in 2020 included online congresses and a webinar series developed by Autoimmunity to educate our customers about new biomarkers. One such assay that was commercialized in 2020 was the QUANTA Flash® Circulating Calprotectin assay. Circulating Calprotectin can be useful in stratifying patients with COVID-19 who are more susceptible for ventilation, or for more general indications for inflammation in many autoimmune diseases.

We also started the limited distribution of the Aptiva® multi-analyte system and reagents. Aptiva will be the cornerstone for our success in the future, with the most comprehensive menu of over 60 analytes in advanced stages of development, and over 15 unique and/or proprietary markers. Additionally, we continued to solidify Autoimmunity as a market leader in our industry through continued expansion of our legacy product line such as BIO-FLASH®, ELISA® and immunofluorescence assay (IFA). We launched the Aptiva system and Aptiva Celiac Assay, QUANTA Flash Intrinsic Factor, QUANTA Flash SARS-CoV2 IgG and QUANTA Flash Circulating Calprotectin.

None of our successes over the past year would have been possible without the extremely talented individuals at Autoimmunity. We are One Team, committed to helping labs improve the way patients with autoimmune diseases are diagnosed, monitored, and treated, through the systems and reagents offered by the business line.

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Limited distribution of Aptiva multi-analyte system and reagents.

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Commercialization of QUANTA Flash Circulating Calprotectin assay.

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Market leader in autoimmunity through continued expansion of our legacy product lines, such as BIO-FLASH, ELISA and IFA.

Original Equipment Manufacturing (OEM)

Jose Luis Zarroca

José Luís Zarroca

COO, Original Equipment Manufacturing

In 2020, despite the challenge of COVID-19, our OEM business line saw double digit growth compared to 2019 year thanks to the strong performance of IVD Biomaterials & Bulks, as well as customized assays developed for third party partners.

According to our customers, we have proved to be a reliable, consistent  and flexible partner by meeting their needs in this difficult market environment, managing to supply more than 250 different products around the world and always fulfilling quality requirements in a timely manner.

Additionally, we sped up our virtual mindset transformation through a digital program, allowing us to stay close to our partners and provide on-time support to overcome their challenges, while continuing to build a strong foundation as a Center of Excellence in the field of immunoassays.

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All-time high sales growing more than 26% versus previous year.

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Successful scale-up of 2 biomaterials, x2 and x10 respectively, for one of the top IVD fastest growing manufacturing company.

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We have attracted 18 new customers based in our capacity to innovate and reliable supply.

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2 customized technology transfer projects successfully executed.

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Commercial launch of seven OEM clinical chemistry assays and three OEM chemiluminescent immunoassays (CLIA) assays for a new platform for a top IVD manufacturer.

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Despite the difficult situation, our partners congratulated us by continuously managing product supply in a timely manner.

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Lead time to major partners  ≥ 95%

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Other businesses

Clinical Software

We are committed to developing and supporting safe, secure, efficient, and innovative clinical applications and laboratory instrumentation systems. Our solutions enhance patient care and facilitate the management of information in hospitals and laboratories around the world.

2020 Highlights

Despite the challenges of working from home from March 2020, the Clinical Software team achieved very good results. Due to its robust infrastructure and planning, the experience and outcome of working from home have been positive. As always, the close collaboration between the Software Development and Quality Assurance/Regulatory Affairs teams was crucial to the success of our projects.

Regarding the project achievements and challenges that Clinical Software has significantly contributed towards, the points to follow are worthy of note:

  • AccuTrack 2.0 for quality control peer-group comparison, was released. It is the first Werfen system deployed globally in a cloud-based platform.
  • Modulab - this well-known laboratory information system has successfully helped many customers after a doubling of laboratory orders handled by the system, allowing clinicians to treat patients in a timely manner.
  • Aptiva® received the European Union’s CE Mark and has been released in select territories.  Aptiva’s comprehensive menu of novel clinically significant biomarkers will help to close the seronegative gap and deliver more complete clinical insights in diagnozing autoimmune disease.

In addition to these achievements, in 2020 a solid test automation strategy was defined, and a dedicated cybersecurity team was formed to work across projects.

Clinical Chemistry

We develop and support safe, efficient, and innovative clinical applications and laboratory instrumentation systems for clinical chemistry and toxicology.

Through our Clinical Chemistry products we offer easy-to-use clinical laboratory instrumentation and reagents for chemistry and pharma-toxicology laboratories. Our unique solutions are used to diagnose conditions, such as diabetes, as well as to identify drug abuse.

Other Specialized Diagnostic products

In addition to our portfolio of proprietary specialized diagnostic products, some of our affiliates, mainly those in Spain, Portugal and Mexico distribute analyzers, reagents and controls from internationally recognized partners. We are proud of these long-standing partnerships which allow us to deliver these products essential to molecular biology, microbiology and applied science.

This segment of our business continues to grow thanks to the specialized, technical and application expertise in our affiliates.

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Medical Devices

We distribute both our own and third-party medical devices such as disposables, orthopedic implants, devices for endovascular procedures and solutions for oncology treatment, as well as third-party scientific instrumentation. Through Izasa Scientific we market scientific instrumentation throughout Spain and Portugal for use in multiple applications in the life science, research, environmental control, and pharmaceutical, chemical and agro-food industries.

Medical Devices & Scientific Instrumentation Distribution

2020 was a complex year due to the lockdowns and restrictions on our normal commercial activities due to the pandemic. And, while sales of products for diagnostic procedures and non-urgent interventions fell, they were largely offset by sales of products destined to help in the fight against COVID-19.

2020 Highlights

  • Izasa Medical, formerly Izasa Hospital, provided much needed support to Spanish hospitals, supplying personal protective equipment (PPE) while maintaining our assistance to critical surgical procedures with our team of specialists and technical service.
  • Despite the negative impact of COVID-19 in the Industrial Quality Control market in Portugal, Izasa Scientific achieved outstanding results in 2020 mainly thanks to the healthy sales performance in the areas of Life Science and Environment.
  • MC Medical, formerly Medicinália-Cormédica, dramatically increased its installed base of Hamilton ventilators for ICUs.
  • Nicolai continued expanding its presence in the gastrointestinal industry.

Infusion Therapy

We develop and support safe, efficient, and innovative clinical applications and laboratory instrumentation systems for clinical chemistry and toxicology. Through Leventon, Werfen offers single-use, continuous infusion systems, gravity flow regulators used in hospitals, and infusion pumps used mainly in the treatment of ambulatory patients to promote patient recovery and improve quality of life by increasing patient mobility.

2020 Highlights

  • Can Margarit – new facilities: Completed the transfer of the entire elastomeric pump DOSI-FUSER® production process. The transfer of DOSI-FLOW® IV flow regulator will end in 2021.
  • Launch of Dosi-Fuser NRFit™ range, designed to improve patient safety and minimize the risk of administering medications erroneously. We pioneered the introduction of this connector integrated into an elastomeric pump.
  • Implementation of new technologies and manufacturing automation, improving product quality in Dosi-Flow and Dosi-Fuser.

Upgrade of our Dosi-Fuser website and app, adding new content and new features for the infusion time calculator tool. During COVID-19 digital platforms became essential and www.dosi-fuser.com greatly facilitates information and instructions to end-users, and is very beneficial for our sales network.

Innovation in R&D

At Werfen our passion for innovation starts with R&D. And with the majority of US News & World Report’s best hospitals, as well as many other hospitals around the world, using our diagnostic solutions, we understand the importance of our products in the delivery of the highest quality patient care. This inspires us to continuously improve our systems, reagents and data management solutions, as well as innovating new ones, to expand our impact on diagnostic testing in hospitals around the world.

Our teams are comprised of highly skilled engineers, scientists and expert project managers. To maximize collaboration and efficiency, the majority of our R&D is conducted completely internally. And, leveraging their close proximity to operations—in Bedford, MA and throughout our technology centers—they optimize product design and efficiency together.

Our approach to R&D is multifaceted, encompassing specialized laboratories and areas of expertise throughout our innovation process.

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Highlights

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The Model Shop

Located steps away from our instrument designers, our unique model shop creates product prototypes internally, quickly and efficiently. A variety of potential materials are available for experimentation. After rigorous testing, input is applied to create modified prototypes, and the process continues until the ideal form and materials are identified.

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Hardware Integration Laboratory

System designs are evaluated in our Hardware Integration Laboratory, where we ensure they meet the highest standards. Prototypes are tested and exposed to a variety of conditions, including the thermal testing chamber, to ensure quality performance in any environment.

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Software Testing Laboratory

Equally important to our solutions is software, designed specifically for each hemostasis system, with customer needs and usability at its core. Hemostasis software is tested with the same rigor applied to our instruments and includes extensive usability research with our customers. This allows us to develop reliable and standardized software solutions with user-friendly interfaces and features.

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Analytical Laboratories – Hemostasis and Acute Care Diagnostics

We develop instruments and a broad menu of assays, for a complete product solution. In our analytical laboratories, our highly skilled, quality-driven and metric-focused teams meticulously verify their combined performance. This allows us to offer our customers a family of products that seamlessly work together to produce the highest quality test results, for the highest quality patient care.

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HemoCell® Lab

For mid- to the high-volume hemostasis laboratories, we offer the industry-leading HemoCell Specialized Lab Automation, a unique work cell, customized to the individual needs and footprints of each lab, and designed for testing efficiency. Here in our HemoCell laboratory, we test methods for continuous improvement, often inspired by customer feedback. Accessories, such as the status-indicator light pole and rinse manifold, are examples of this, arising from our in-depth R&D process.

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Early-Life Monitoring and Systems Engineering

The R&D process doesn’t end when a product goes to market. Early-life monitoring and tests by systems engineering of our on-market products can detect performance trends. Customer feedback is crucial to the product life cycle management of all our instruments, software and reagents allowing us to continuously improve the quality of our products.

From prototyping to addressing on-market product needs, R&D is the hub of innovation at Werfen. Our passion for R&D sparks the hearts of all our employees and drives us to deliver the best diagnostics solutions to our customers—for the best patient care.

Commercial Operations & Region Sales

The regions, which include dedicated country-specific teams, are organized into five regions – North America, China, Asia Pacific, EMEAI and Latin America

Brian Durkin
Brian Durkin

Vice President, Commercial Operations, North America, Hemostasis and Acute Care Diagnostics

Hemostasis and Acute Care Diagnostics

While 2020 presented extraordinary challenges, the Commercial Operations team in North America harnessed their resiliency and achieved extraordinarily positive results. Despite COVID-19 restrictions at customer sites, our Service, Support and Applications groups not only met all customer field requirements, but exceeded expectations, reinforced by extremely positive customer survey results. Through a combination of remote and on-site meetings with customers and prospects, and a boost of ingenuity, our Sales team delivered record instrument and reagent sales in both Hemostasis and Acute Care Diagnostics, led by our flagship ACL TOP® Family 50 Series and GEM® Premier™ Family systems. Ultimately, the combination of best-in-market products, our highly trained and engaged Commercial Operation team, and continued investment in process efficiencies, led to our collective success in 2020.

Bryan Hoenig
Bryan Hoenig

Vice President, Commercial Operations, North America, Autoimmunity

Autoimmunity

In a year that presented unprecedented challenges, we launched an exciting foundation for our future success with Aptiva®, our new multi-analyte system. We initiated the limited distribution of Aptiva in Europe and submitted the system and reagents to the US FDA in late 2020. Through the virtual support of our people, we navigated the difficult year and met the changes and challenges together.

In 2021, we will continue to launch Aptiva in expanded geographies and leverage our focus on IT and artificial intelligence to further define our precision medicine strategy for the future.

Jaume Serra
Jaume Serra

Vice President, EMEAI and Latin America

COVID-19 had a major impact on the regions in 2020, but generally we overcame the challenge and turned it into an opportunity. In addition to our hemostasis and blood gas systems proving critical to treating patients with COVID-19, our offering of best-in-class PCR testing solutions in specific geographies added great value for our customers and patients. Support activities in the field proved very difficult at the start of the pandemic but stabilized soon thereafter. Face-to-face commercial activities have proven to be more difficult, but our teams have continued to stay close to our customers and present the value of our solutions through remote, hybrid channels. Our overall results were better than ever in 2020.

Gilles Castera
Gilles Castera

Vice President, China

In 2020, China saw its hospital activity decrease by 20%, due to COVID-19 preventive measures implemented by provincial governments.

Throughout the crisis, especially during the peak winter months, the safety of our staff members and the supply of our products and services to hospitals continued being the priority. Later in the year, the team’s high level of commitment led to a strong recovery, growing the number of HemoCell installations by 66% over 2019, while GEM® Premier™ family sales grew by 65% and BIO-FLASH® installations by 20% year-on-year. Worth noting is that 2020 was also a year of intense creativity, particularly for online activities.

Ted Maione
Ted Maione

Vice President, Asia Pacific

In 2020 Asia Pacific (APAC) demonstrated that it is the right team, with the right strategy, the best products and the absolute desire to deliver above market growth well into the future. The region, which is comprised of Japan, Korea, Australia and New Zealand, and the South East Asian countries, Hong Kong and Taiwan, had another successful year despite the challenges posed by the pandemic.

APAC is of key importance as it offers the opportunity for substantial growth over the mid- to long-term. From a financial viewpoint in 2020 we grew sales by 6.5% year-on-year and operating income by 10%, exceeding budget by 5.5%. Additionally, we increased our workforce by 8%, with plans to add another 12% in 2021. We expanded our organization across all geographies and disciplines, with a continued focus on improvements and growth in the areas of clinical specialization for both Acute Care Diagnostics and Autoimmunity. A fair portion of the expansion in APAC was strategically directed toward the Acute Care Diagnostic organizations to optimize for the important synergies of these product lines. We feel strongly that APAC is well positioned to demonstrate the value our products deliver to the market. We are very pleased with our team at all levels and are confident that the team will deliver above market growth well into the future.

Our Quality Policy

Reaching for a higher standard

Ted Maione
Marc Bellosta

Vice President, Quality Assurance & Regulatory Affairs, and Sustainability

All our systems, reagents and data management solutions must meet our exceptional standards. We always go the extra mile – across all business lines and geographic areas–making sure we deliver only the best. Werfen has 51 ISO certificates – an indication of our constant commitment to quality, sustainability and our customers.

QA/RA Mission Statement

Facilitate innovation by providing a framework that ensures high product and service quality, while meeting legal and regulatory requirements through collaboration with all interested parties, balancing risks with benefits.

ISO Certificates

The International Organization for Standardization (ISO) issues ISO Certificates to ensure the safety, reliability and quality of products and services.

  • ISO 9001

    Ensures that the organization provides products and services that consistently meet customer and regulatory requirements, and that the organization consistently aims to enhance customer satisfaction.

  • ISO 13485

    Ensures that the organization provides medical devices and related services that consistently meet customer and regulatory requirements. All Werfen manufacturing sites are certified with this standard.

  • ISO 14001

    Ensures that the organization strives to manage its environmental responsibilities in a systematic manner and in compliance with international and local environmental regulations.

  • ISO 27001

    It ensures that the organization safeguards the security of assets such as financial information, intellectual property, employee details or information entrusted to you by third parties.

Compliance

Albert Garicano
Albert Garicano

Compliance Officer

This department is responsible for preparing, monitoring, and managing all topics related to compliance and the Werfen Code of Ethics, including adhering to existing internal and external rules and regulations.

Compliance Officer, Albert Garicano, and our local compliance officers are committed to ensuring that our Code of Conduct is consistently complied with worldwide.

Werfen’s mission is to improve the quality of laboratory medicine worldwide. This mission is accomplished through affiliates, which foster and promote Werfen Values. However, in many other geographic areas we operate through a wide network of business partners. Our responsibility and commitment to the highest ethical standards does not end with our employees, but also includes those who work on our behalf.

For this reason, in 2020, we launched a new due diligence process to strengthen our compliance program. Covering all aspects of the integrity checks of our business partners, it meets complex international law requirements. The due diligence process enables us to promptly identify compliance risks, initiate appropriate measures to mitigate them and avert damage to the company.