Newbury Pharmaceuticals interim report September 2021 – November 2021

Quarter 1, September 2021 – November 2021
· Operating cash flow was -4 744 (-49) tkr.
· Cash position in the end of period was 7682 (51) tkr.
· Licensed products in the end of period were 25.
· Products with marketing authorization in the end of the period were 1.

Events during the quarter
· The management was strengthened with CEO Lars Minor and CFO Christoffer Tell.
· Enlargement of the portfolio with additional seven (7) oncology products; Nintedanib, Palbociclib, Pomalidomide, Nilotinib, Enzalutamide, Lenvatinib, Bosutinib.

Events after the end of the quarter
· Enlargement of the oncology portfolio with the addition of Lapatinib.
· Agreement on an exclusive license to commercialize its own brand of Teduglutide 5mg prefilled syringe in the Nordics.

A word from the CEO
Strong focus on building an excellent pipeline
Newbury pharmaceuticals has continued to build a portfolio of specialty medicine, advanced regulatory filings to 11 products and received the first product approval with “Icatibant Newbury” in Sweden and Norway. Preparations are taking place for launch in early 2022.

Strengthening the pipeline
Successful enlargement of the portfolio with first additional seven (7) oncology products and subsequent after the period end, additionally one (1) oncology product. These 8 products strengthen the focus on oncology with a total of 11 oncology products in the pipeline. Regulatory fillings will take place over the next few years, and we aim to be among the first to launch many of these medicines in Scandinavia where the current total annual market value of the oncology portfolio is estimated to be 400 MEUR according to DLMI Nordic Pharma Insights.
In December, we signed a strategic agreement for in-licensing of a treatment for short bowel syndrome in the Nordics and thereby strengthened the strategic focus on rare diseases. It is an exclusive license to commercialize our own brand of Teduglutide 5mg pre-filled syringe in the Nordics. Newbury plans to be the first-to-file and first-to-market of this highly complex peptide injectable product following patent expiry. The portfolio addition brings a unique opportunity to help more people suffering from short bowel syndrome access this innovative treatment.

Building the organization
The organization has been expanded with Lars Minor as CEO and Christoffer Tell as CFO from 1st of September 2021. The company has worked to upgrade its corporate identity including web presence. The financial results demonstrate the focus on scaling the company for future launches and identifying new license opportunities as well as ongoing regulatory filings of our portfolio. All together we are making strong progress and are well prepared for further developing the company.