Novo Nordisk A/S

Welcome to this Novo Nordisk earnings call for the first three months of 2022 and outlook for the year. This call follows the early announcement and race guidance published earlier today. Due to securities regulations, we had to advance the release that was originally scheduled for Wednesday next week. My name is Lars Rurgard Jorgensen and I am the CEO of Novo Nordisk. With me today I have Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Silvestre. Executive Vice President and Head of North America Operations, Doug Lange. Executive Vice President and Head of Development, Martin Holtz Lange. And finally, Chief Financial Officer, Carsten von Knudsen. All of us will be available for the Q&A session. Today's announcement and the slides for this call are available on our website, noelnoels.com. Please note that this call is being webcasted live and a recording will be made available on our website as well. The call is scheduled to last for one hour. Please turn to the next slide. The presentation is structured as outlined on slide two. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified. The Q&A session will begin in about 25 minutes. Please turn to slide three. As always, I need to advise you that this call will contain forward-looking statements. Such are subject to risk and uncertainty that could cause actual results to differ maturely from expectations. For further information on the risk factors, please see the company announcement for the first three months of 2022 and the slides prepared for this presentation. Please turn to the next slide. In the first three months of 2022, we delivered double-digit sales and operating profit growth, which has enabled us to raise our outlook for the full year. I would like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues. Within purpose and sustainability, we reached an important milestone with a positive scientific opinion from EMA on human insulin. This will allow for more flexible storage without refrigeration for three weeks if kept below 30 degrees Celsius. This positive opinion will support obtaining approval from local health authorities in low and middle income countries. With this, we aim to improve flexibility and convenience for many people living in these countries who have limited access to reliable cold storage and may live far away from a clinic or pharmacy. Following Russia's invasion of Ukraine, our key priorities have been to safeguard employees and continue the supply of essential medicines. In addition, we have donated two months' supply of diabetes and hemophilia medications to the Ukrainian Ministry of Health. In collaboration with humanitarian organizations, we continue to monitor the situation to be able to provide further support. Within R&D, we are encouraged by the first phase 3 trial with once-weekly insulin IQODEC, showing the potential to improve glycemic control with greater convenience and a reduced treatment burden for people needing insulin treatment. This is an important step in support of our aspiration of further raising the innovation bar for diabetes treatment and our commitment to insulin innovation. We are also satisfied with the progress made in the first quarter with our late-stage pipeline in rare disease. Martin will come back to this and our overall RD milestones later in this call. In the first three months of 2022, we delivered double-digit growth in sales, reflecting solid commercial execution across geographies and our therapy areas. Specifically, the growth is driven mainly by accelerated demand for our GLP-1 treatments, which has enabled us to increase the outlook. Regarding the supply situation for Wegovi in obesity, the CMO has restarted production and we expect to make all Wegovi doses available in the U.S. during the second half of 2022. Camilla and Doug will go through the details of the therapy area later. Lastly, Carsten will go through the financial details but I'm very pleased with the sales and operating profit growth of 18% in the first three months of 2022. With that, I'll give the word to Camilla for an update on commercial execution.

Thank you, Lars, and please turn to the next slide. In the first three months of 2022, our total sales increased by 18%. The sales increase was driven by both operating units with international operations growing 13% and North American operations growing by 24%. Our GLP-1 sales increased 45% driven by North America growing 38% and international operations growing 60%. Insulin sales decreased by 4% driven by 1% growth in international operations, offset by a 15% sales decline in North America operations. The U.S. insulin sales declined by 16% driven by lower realized prices and a decline in volumes. Obesity care sales grew 107% overall. In international operations, Saxenda sales grew 63%, and in North America operations, obesity care sales grew 146%. In the U.S., obesity care sales grew 158%, driven by both Saxenda and Vigobi. Total rare disease sales increased by 3%, driven by both operating units growing 3%. Please turn to slide 6. Our 16% sales growth within diabetes care is faster than the overall diabetes market. That means we have improved our market share by 1.2 percentage points to 30.5%, and that we continue to be on track to reach one-third of the diabetes value market by 2025. The increase reflects GLP-1 growth of 45% and market share gains in both operating units. Please turn to the next slide. In international operations, diabetes care sales increased by 13% in the first three months of 2022, driven by all regions and mainly by GLP-1 sales that grew by 60%. Novo Nordisk remains the market leader in international operations with a GLP-1 value market share of 60.1%. This is driven by share gains across geographies, and Othempic remains on track to become the GLP-1 market share leader with a 36.1% market share. And with that, I will hand over the word to Doug.

That update, Camilla. Please turn to the next slide. The U.S. GLP-1 market grew more than 30 percent, comparing Q1 of 2022 to Q1 of 2021, with once-weekly injectable GLP-1s and Rebelsys as the main drivers. From an NBRX perspective, we have seen a step up in volume growth in 2021 that has accelerated further since the beginning of 2022 as shown on the left-hand side of this slide. Measured on total scripts, Novo Nordisk remains the market leader, 54.2% market share. We're also excited with the approval of Ozempic 2mg by the FDA in March. That will be an option for type 2 diabetes patients who may require both glycemic control. We expect to launch Ozempic 2mg in the US in the coming weeks. The global rollout of Rebelsis is progressing well, and it has now been launched in 34 countries. In the U.S., Rebelsys' total prescription trajectory continues to steadily increase, and it remains one of the key contributors to growth in Novo Nordisk. Outside the U.S., Rebelsys in Japan has now reached a 4.2% value share in the modern oral antidiabetics market after the 14-day prescription limitation was lifted in December of 2021. This compares to a 2.6% value share when we released our full year's result in February. Please go to the next slide. Globally, obesity care sales increased by 107%, with 146% growth in North America operations and 63% in international operations. In the U.S. alone, obesity care sales grew 158%. We are also excited to share the obesity care split brand To be specific, the total obesity care sales were 3.4 billion kroner, with 2 billion coming from Saxenda and 1.4 billion coming from Wagovi in the U.S. Next slide, please. As you know, the demand for Wagovi has exceeded expectations. And during the first quarter of 2022, weekly prescriptions in the U.S. have been above the 20,000 level, that we communicated we could supply in connection with the full year results in 2021. Our focus remains to ensure continuity of care to the patients that have already initiated treatment. We have put sales and marketing activities on hold, and to further prevent new patients from initiating treatment, we stopped the supply of the first two Regovi dose strengths, the 0.25 and 0.5 milligram in March. As Lars mentioned earlier, The CMO filling syringes for Wegovy has restarted production, and our expectation remains to make all Wegovy dose strengths available in the U.S. during the second half of 2022. On Wegovy market access, I'm happy to share that we have added the Department of Defense as a reimbursed channel. In addition, we have also progressed on commercial formulary access, which is now around 80% for Wegovy, and employer negotiations are progressing. Now back to Camilla for an update on rare disease.