Novo Nordisk Pharmatech A/S

Management reviewNovo Nordisk Pharmatech A/S glance70 YEARSNovo Nordisk Pharmatech is a global company with 70 years of extensive experience supplying ingredients and API for the biopharmaceutical and pharmaceutical industries.HERITAGEPart of Novo Nordisk, a global healthcare company with more than 90 years of innovation and leadership in diabetes care, ensures we have the experience and capabilities to improve biopharmaceutical manufacturing.CUSTOMERSWe are proud to supply the largest pharmaceutical companies worldwide with continuous high quality products.QUALITYWe never compromise on quality. By consistently meeting expectations and the needs of our stakeholders, we safeguard product quality and ultimately safeguard the patients. Our track record proves this.PRODUCTSWe live up to our customers’ uncompromising standards by providing pure, efficacious and safe products every time.MARKETNovo Nordisk Pharmatech is the worldwide leading supplier of recombinant insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds (Quats).Letter from managementIn 2019, we took the next steps to prepare for our future growth. We continue to invest in our systems to ensure that they are robust and secure for the future, and we initiated an investment to upgrade a facility at our site in Køge.Our investments have largely been within IT, where security and business continuity are top of the agenda. Part of this investment includes an increase in staffing to cope with the current and cuture challenges, and further digitalisation of our operations.Another major area of investment was the initiation of a new multi-purpose facility to handle the downstream manufacturing of a broader portfolio of recombinant expressed proteins for the global biopharmaceutical market. This is set to continue into 2020, and we expect to take the facility into use in late 2020.In 2019, Novo Nordisk Pharmatech opened a branch office in Singapore. The new office will head up our efforts to grow our current portfolio of products in the Asia Pacific market, as well as prepare for the launch of new products in the same area. We were happy to welcome new colleagues with local market and industry knowledge, who will help bring our sales operations closer to our costumers and the market we serve.Sales-wise, Novo Nordisk Pharmatech had a challenging year. This was partly expected due to a major customer seeking other supply opportunities in the Quats market, as well as lower growth in North America. The sale of technical insulin was also challenged, and we were impacted by a major customer adjusting inventories, and another who postponed campaigns to 2020. Demand was therefor lower than expected, and is expected to decline further in 2020.In 2019, Novo Nordisk Pharmatech maintained its outstanding track record for audits and inspections. Numerous customer audits were carried out, as well as ISO audits, internal audits, and inspections from authorities. The takeaway from all this is that Novo Nordisk Pharmatech maintains high standards and goes above and beyond the expectations of both customers and authorities.The delivery of enzymatic products to Novo Nordisk was in line with expectations. Meanwhile, a number of minor optimisations of the manufacturing facility were carried out throughout the year. Resin production was very stable, and the required volumes were delivered.For R&D, 2019 was a busy year. This was characterised by a growing portfolio of products and a growing organisation tasked with meeting future market demands for ancillary materials within our current scope of business, as well as the manufactering of regenerative medicins. The product portfolio is mainly increasing within our enzymatic and resin products, and the larger pipeline will serve as a future growth engine for the company.With progress in our R&D pipeline, a strong quality base, a broader sales reach, improved IT systems and security, as well as an improved manufacturing infrastructure, Novo Nordisk Pharmatech has strong foundation to meet future challenges.RASMUS HOTHER LE FEVREPresident & CEOFinancial review2019Revenue and EBIT developmentOverall revenue in Novo Nordisk Pharmatech in 2019 was DKK 621 million . This is a decrease of DKK 70 million (-10%) compared to 2018, when total sales were DKK 691 million. The main drivers of this development were•   Sales of ALP to Novo Nordisk were DKK 19 million (-13%) lower than 2018 due to price adjustments .•   Sales of Silica to Novo Nordisk were DKK 23 million (-16%) lower than 2018 due to price adjustments partially off-set by increased volumes•  Sales of columns were DKK 4 million (126%) higher than 2018 driven by price adjustments resulting from low production,•  Sales of insulin to the global market were DKK 1 million higher than 2018 driven by the favourable impact of the USD exchange rate and higher average selling prices, which was offset by lower volumes (KG) sold due to loss of orders from large customers.•   Sales of Quats (synthetic molecules) to the global market were DKK 31 million (-24%) lower than 2018 driven by a decrease in volumes due to the loss of a major customer.•   Sales to group companies in 2019 account for 43% of total sales vs. 45% in 2018.Total costs in Novo Nordisk Pharmatech were lower than 2018, primarily due to lower raw material costs, driven by lower Quats sales, production and inventory revaluation, Capacity costs increased in line with expectations in 2019, due to a continued focus on new business development improved IT systems and security. This has been partially offset by lower depreciations due to large asset write downs made in 2018.Net operating profit for 2019 was DKK 97 million, decreasing from DKK 105 million in 2018. The decrease in net operating profit is mainly driven by lower revenue on sales of synthetic molecules (2019: 102 million compared to 2018: 131 million). This has been partially offset by lower raw material costs.Outlook 20202020 will be a challenging and exciting year for Novo Nordisk PharmatechWe expect to see the first results from our new local sales office in Singapore. After a challenging 2019, we anticipate growth in the sales of both Quats and insulin, despite increased competition from low cost manufacturers and generic biopharmaceutical manufacturing processes without the need for insulinin the cell culture. We expect a healthy underlying growth in the global biopharmaceutical industry.Demand for purification resins is expected to be stable in 2020, We will continue to increase our efforts and investments in R&D to develop better resins for the future needs of the global biopharmaceutical market.We will continue our efforts and investments in a new multipurpose facility to handle a more diverse enzymatic product portfolio. This will enable us to serve the Novo Nordisk demand of materials to the production of newly launched products with in diabetes care. This facility is expected to fuel the longer-term growth of Novo Nordisk Pharmatech..Besides investments in new physical assets, we will continue to upgrade our IT infrastructure to make it more robust and secure for future demands.Overall sales are expected to decline further in 2020 due to the investment in and rebuild of our enzymatic production facilities despite expected growth within Quats and Insul in. As a consequence the operating profit is expected to be lower than realised in 2019.Novo Nordisk Pharmatech has adopted the Novo Nordisk environmental strategy 'Circular for Zero', launched in 2019. The strategy builds on a long tradition of improving the environmental performance of the company, where for example, all energy consumption has been converted to renewable sources. In 2020, the company will continue this journey by further reducing waste from its operations.Our Business modelNovo Nordisk Pharmatech improves biopharmaceutical manufacturing by developing and supplying innovative products used in the manufacturing of biopharmaceuticals (Biopharmaceuticals are medicine based on biological molecules, such as insulin, growth hormone and blood coagulation factors). In this way, Novo Nordisk Pharmatech improves biopharmaceutical manufacturing - and makes biopharmaceuticals cheaper to produce, thereby enabling better access to medicine for patients.Our innovationA wide range of capabilities are available at Novo Nordisk Pharmatech within the various departments, Sales and Marketing, R&D, Manufacturing , Quality, Business Support and HR & Communication. All capabilities present in the company are critical for Novo Nordisk Pharmatech to run the business and innovate. The following "Core Capabilities" of Novo Nordisk Pharmatech are those that stand out as unique to Novo Nordisk Pharmatech, and are fundamental to the future growth of the company•    Designing and developing silica gels: Novo Nordisk Pharmatech has a long history of continuously reducing the cost for Novo Nordisk of producing insulin by providing robust silica gel and developing processes for increasing their life time.•    Advanced microanalysis: At Novo Nordisk Pharmatech 's Microanalysis Centre, a highly skilled team supports Novo Nordisk with state-of-the-art microscopy and spectroscopic support, This capability is also critical for the development of new chromatographic resins.• Organic chemical synthesis manufacturing: Novo Nordisk Pharmatech has from the outset produced Quats by organic synthesis manufacturing and has gained solid experience within the field.• cGMP embedded throughout the organisation: Biopharmaceutical companies are required to operate in accordance to cGMP in order to ensure patient safety. For Novo Nordisk Pharmatech to be a preferred supplier to the biopharmaceuitcal industry cGMP therefore is a key capability.Novo Nordisk Pharmatech's R&D pipeline comprises several new products under development. Every new product goes through the four phases1. Idea phase, where the potential value of the product is analysed2. The R&D phase, where the product is developed in the lab in close collaboration with customers3. The tech transfer phase, where the technology is transferred to production and the production facility is built, and4. The launch phase, where the product is introduced to the market.Our way of doing businessWe ensure high quality in our products by meeting the expectations and needs of our stakeholders. We strive for simplicity and never compromise on qualityThe development of new products is based on the requirement from the customers and the final use of the product. Quality by design is used during development to ensure that quality is built into the product, with a high focus on product and process understanding, as well as on process control as opposed to relying on testing of the final product. From development through tech transfer to production, our Quality Management System (QMS) ensures that knowledge is handed over, thereby ensuring that employees understand both why and how to ensure quality. It is part of our strategy to safeguard product quality and compliance, thereby safeguarding the patient. Our QMS is based on ISO 9001 and covers processes from development to post-delivery activities. We strive for simplicity and we develop and maintain a process-oriented QMS based on our stakeholders' expectations, as well as legislation and requirements from authorities, e.g. "EU GMP vol. 4 part II". "ICH Q7" and "The Joint Good Manufacturing Practices Guide for Pharmaceuticals Excipients" . The drug substance production is inspected by the Danish Medicines Agency on a regular basis and we are also inspected by the FDA. Aud its from our customers are part of our quality agreements with them. Historically, the results of these inspections and audits have shown a very high level of compliance.Strategic prioritiesImproving Biopharmaceutial ManufacturingExcellence. MultipliedBy delivering excellence at every step, we help our customers do the same - whether they're developing a cure for cancer, or a new ophthalmic. Excellence multiplied, from discovery to delivery.We strive for perfectionEvery new idea needs a great execution. By delivering on time, reducing risk and ensuring compliance, we give our customers the security they need to develop and manufacture products that make a difference.Our ambitionTo improve biopharmaceutical manufacturing through our core values; purity, reliability, consistency and quality.PurityWe live up to our customers' uncompromising standards by providing pure, efficacious and safe products every time.ReliabilityOur secure global supply chain ensures dependable availability, precision delivery and a continuous supply of products.ConsistencyWith well-established manufacturing, analytical and quality processes, we deliver constant product consistency and compliance.QualityOur tight control measures, assurance systems and professionalism ensure that every product supplied is of the highest possible quality.Business segmentsBiopharmaceutical proteins are produced by1. Expression of the protein by living cells2. Capture of the protein3. Modification of the protein to direct its biological function in the human body4. Purification of the modified protein to remove unwanted impurities from the expression and modification steps5. Preparing a formulation of the modified protein to ensure efficient and safe delivery into the human bodyThe role of Novo Nordisk Pharmatech’s productsInsulin’s role in Expression is to make the living cells grow and divideSynthetic molecules are used in the capture of flu vaccinesEnzymes are used to modify proteinsPurification resins are used to purify peptides and proteinsSynthetic molecules are used as preserving agents in final formulations or as an APISupporting the local communityTo celebrate World Diabetes Day on 14 November 2019, Novo Nordisk Pharmatech collaborated with the local Køge Diabetes Association and Køge Library to create an awareness event.The local Køge Diabetes Association was present at the library to create awareness of the disease and the risk factors. Novo Nordisk Pharmatech created the opportunity for Køge citizens to learn more about living with the disease from two lecturers, who both live with Diabetes. Lectures were also given by a doctor and health expert as part of the event.On 26 November 2019, Novo Nordisk Pharmatech employees volunteered at a local volleyball tournament to strengthen awareness about healthy lifestyles, and hosted activity stations for second grade students from schools throughout Køge Municipality.To support the academic environment of Denmark and a strong, knowledge-based and innovative culture at Novo Nordisk Pharmatech, we continuously take in internships and master thesis projects. In 2019, 5-7 internships/master thesis projects generated knowledge for Novo Nordisk Pharmatech and vital experience for the students.To support the education of youth, Novo Nordisk Pharmatech offered one-week internships for three elementary school students. This process is integrated in the HR yearly wheel and remains a prior it ised activity for the future.Marketed productsInsulin and Future developmentNovo Nordisk Pharmatech is a leading global supplier of high­ quality ingredients for the biopharmaceutical industry. Our recombinant Insulin has been a critical raw material of the upstream process of large-scale manufacturing of cutting-edge biologics, such as therapeutic antibodies, recombinant proteins and vaccines for the last 2 decades. The majority of the current blockbuster drugs are depending on our Insulin but within the next decade, patents on some of these are scheduled to expire in the EU and US, which will open the space to new biosimilars entering the market. In addition, new technologies such as highly-performing chemically defined CHO media allow high productivity in the absence of supplements such as Insulin. We will need to strategically work closely with both big pharma and smaller upstarts to secure presence and growth within new molecules in early development.On the other hand, regenerative medicine is an important growth segment. Stem cells, cell and gene therapy and CAR-T are the main therapeutic segments which are estimated to reach $13 billion by 2025 at a double-digit annual growth rate, with more than 400 programs have already entered clinical development.Sourcing of ancillary material for these advanced therapy medicinal products (ATMPs) is critical for quality, consistency and supply chain continuity. Our strategic focus will be to target this attractive market not only with Insulin but also with new products we are developing to specific tailor the need of these customers, both in upstream and downstream processes of ATMPs.QuatsNovo Nordisk Pharmatech is the leading supplier of cGMP Quaternary Ammonium Compounds (Quats) for a wide range of applications. Our Benzalkonium Chloride, Cetrimide and Cetrimonium Bromide (CTAB) products act either as preservatives or active ingredients in many ophthalmic, nasal, oral and topical drugs and in a variety of solutions, ointments and creams They can also be used as lysing or precipitating agents in vaccine production.During the past three years, we have intensively increased our global presence, both by opening a branch office in Singapore, and by appointing local distributors and agents. Our current partners are representing us in Canada, USA, Brazil, India and several APAC, CEE and European countries. During the coming year, we plan to continue expanding our presence in Latin America as well as the CIS Region.We will continue improving our product documentation for specific applications. We also see an increase in regulatory expectations, to guarantee patient safety in today's expanding global market, Our customers see us as the market leader in the industry, and we will continue to match and outperform the requirements for the local markets.Risk managementManaging risk is central to the business in Novo Nordisk Pharmatech, as it is critical for us to protect our assets, our employees, and the business of our customers. It is the responsibility of the management board to review the overall risk exposure of the company. For this purpose, a risk assessment process is in place, where relevant risks are identified and assessed on a frequent basis. On the basis of this assessment, mitigation plans are evaluated twice a year, and subsequently reported to the Board of Directors as a standard agenda item at Board meetings.Risks are assessed based on the likelihood of events, as well as the potential impact of events on our business to reach short and long-term objectives. This assessment is anchored in the strategic planning process presented to and approved by the Board of Directors on an annual basis.The top two risks for Novo Nordisk Pharmatech in 2019 were identified as1. Anti-corruption and BriberyAs Novo Nordisk Pharmatech operates in a global market, we also adhere to the highest standards of business ethics in our dealings with external parties. All relevant employees receive mandatory e-learning training, as well as training from legal experts in order to counter corruption and/or bribery attempts.Our operating model is to use distributors in global markets, and our distributors are trained and contractually obliged to uphold the same standards.2. Health & SafetyOur production processes involve chemicals that are potentially hazardous to the health and safety of our employees as well as the local environment. Therefore, we are continuously investing to mitigate the risk of adverse situations in this area. A major focus in 2019 was to upgrade the access security and physical security of our site.3. EnvironmentalWe are continuously reviewing our environmental mitigation plans to ensure we are equipped to deal with abnormal climate situations - for example, the aftermath of flooding or heavy rain as we are situated close to sea level.4.  Commercial risksAs part of annual budgeting and follow up, we build in expectations to market development short term, mid term and long term.For the Quats market, we see an underlying short term increase in the market, but long term a trend away from usin g preservation chemicals in final products, and end customers are looking for alternatives to this. This can threaten the long term growth of our Quats business.For the technical insulin market, we do see a long term trend towards using chemically defined growth media instead of e.g. e-coli based growth media, where insulin is needed, and this can also threaten the long term growth of our insulin business.5. Human rightsNovo Nordisk Pharmatech follows the Group policy for human rights in the Novo Nordisk group. Due to the nature of our business, our suppliers and distribution set-up it is our assessment that human rights is not a significant risk and therefore no mitigating actions are put into place.