“2022 was a fantastic year for Calliditas as we launched TARPEYO® in the US, the first approved drug for IgA nephropathy and a medication with the potential to be disease modifying based on the early stabilization of eGFR in patients at risk of rapid disease progression. We achieved total revenues of SEK 802.9 million ($79.3m) for the year of 2022, which represent an increase of 250% compared to 2021, whereof SEK 372.2 million ($36.8m) was net sales of TARPEYO for the first 11 months of commercialization. We are immensely proud of this result, and we look forward to continuing to support the patient community with a drug which is designed to target the origin of the disease and thus help keep patients out of dialysis. We end the year with a very strong cash position of SEK 1,249 million ($119.7m) which reflects a successful non-dilutive capital raising approach, and we believe that we are, based on our guidance for TARPEYO, funded to profitability and well prepared to capitalize on growth and opportunities in 2023.
In the fourth quarter, we continued to build on our commercial success in the US, seeing record average weekly patient enrollment numbers towards the end of the quarter, despite the Thanksgiving and Christmas holidays. The revenue impact of these enrollments is only partly reflected in Q4 revenues due to the requirement for insurance plan approvals for specialty products under the US healthcare system. Total Q4 revenues were SEK 429.0 million (appr. $42.4m), out of which net sales from TARPEYO amounted to SEK 167.3 million ($16.1m), resulting in an operating profit of SEK 32.5 million (appr. $3.2m) and a positive cash flow from operating activities of SEK 230.0 million (appr. $22.7m) for the fourth quarter. Prescribing nephrologists continue to grow bringing total unique prescribers to 642 for the year. New enrolments amounted to 310 in Q4, resulting in a total of 1,039 enrolments for the year.
In October, Kidney International published a peer reviewed article containing the details of Part A of our NefIgArd trial. We were delighted that, with the Phase 3 trial now approaching its completion, we were in a position to share this information. The data was very well received by nephrologists, as reflected by the high level of interest at the American Society of Nephrology’s (ASN’s) Kidney Week in Orlando in early November. We were very encouraged by the positive feedback from the many interactions during the conference and by the many discussions that took place about TARPEYO in various forums. It is clear from these interactions that as more eGFR data generally becomes available it will ultimately drive treatment decisions, as the goal of treating physicians is to protect kidney function rather than to address symptoms, and we are excited about being able to share long term eGFR data in 2023 as Part B top line data becomes available, which we hope to be able to announce around mid-March.
For the year of 2023, we estimate net sales from TARPEYO of between USD 120-150 million, reflecting continued market penetration now that the full Part A data is available, combined with the streamlining of market access, and increased peer to peer recommendations based on the early patient successes we are starting to hear about. We believe that strong topline data from the Part B from the NefIgArd trial could provide momentum to uptake as the long term eGFR data will provide additional insight into the potential for kidney protection and disease modification achieved by the TARPEYO treatment.
We also made progress with regards to our global Nefecon franchise. In early November our partner, Everest Medicines, received an acceptance of their New Drug Application (NDA) for approval of Nefecon in China, which was followed by a subsequent Priority Review decision recommendation by the Chinese NMPA in December. In December we also entered into another important partnership deal related to out licensing of Nefecon for Japan and received an initial upfront payment of USD 20 million upon signing with Viatris Pharmaceuticals Japan, who will develop Nefecon for patients in the Japanese market. We look forward to collaborating with our partners to bring Nefecon to patients as quickly as possible.”
CEO Renée Aguiar-Lucander
Source: https://www.prnewswire.com/news-releases/calliditas—year-end-report-2022-301754066.html
Image: https://www.medtecheurope.org/
