Newbury Pharmaceuticals interim report September 2022 – November 2022
“We see a strong momentum with increasing interest from collaboration partners which already has resulted in two new products available for tender participation. In addition, we continue making advancement of our pipeline with regulatory submissions and approvals.”
– Lars Minor CEO
Quarter 1, September 2022 – November 2022
· Net revenue was 258 (0) tkr.
· EBITDA was -5 442 (-3 553) tkr.
· Operating cash flow was -5 215 (-4 744) tkr.
· Cash position in the end of period was 27 393 (7 682) tkr.
· Licensed products at the end of period were 30 (17).
· Products with distribution rights at the end of the period were 2 (0).
· Products with marketing authorization in the end of the period were 7 (0).
Significant events during the quarter
· Pareto Securities will act as liquidity provider for the Newbury share with start 6th September.
· Winning a tender for Sunitinib in Norway and winning the period of the month (Nov) for Icatibant in Sweden combined worth app 500 tkr.
· Teriflunomide Newbury approved by the Norwegian Health Authorities.
· Expands its portfolio with two ready to launch products, Daptomycin and Linezolid with already granted Marketing Authorizations (MA) in Sweden.
Significant events after the end of the quarter
· Fampridine Newbury approved by the Swedish Health Authorities.
· Redeye initiated coverage of Newbury Pharmaceuticals.
· Announcement of sales orders confirmed for international markets totalling app. 6.2 MSEK during 2023.
· Withdrawal of Gabapentin marketing application due to increased regulatory requirements.
A word from the CEO
This Quarter was characterized by a high level of business development initiatives and making further progress on advancing our portfolio with regulatory approvals.
Business development:
We successfully participated at the most important annual congress called CPHI in Frankfurt. It was an opportunity to meet existing and new potential partners who can offer new products for future commercialization. In addition, we participated in Jefferies investor and partnering event in London.
We have signed two partnerships granting us access to two already approved products in Sweden. We thereby increased our portfolio to 32 products of which 8 are registered and 2 are launched.
Commercialization:
Sales in this Quarter was isolated to winning the tender for Icatibant Newbury in Sweden during November. We are pleased with the performance of this product and happy to see that we also were rewarded the period of the month in January in Sweden. Lenalidomide Newbury 5mg also won the January period of the month and it will be followed by additional product launches during 2023.
Furthermore, our international sales activities have generated sales orders for shipments during 2023 totalling app 6.2 MSEK.
Regulatory approvals:
We have obtained approval of Teriflunomide and Fampridine during the recent months. With the addition of two new products with already-granted marketing approvals, we now have 8 products approved across Scandinavia.
By the end of December 2022 new regulatory requirements for approval of Gabapentin were raised by the authorities and together with our license partner, we decided to withdraw the application due to delayed timeline, increased costs, and challenging market conditions. The license fee will be compensated whereas regulatory costs will be written-off in Q2. The product withdrawal will have no significant impact on Newbury future earnings.
There are many on-going regulatory procedures across Scandinavia for our portfolio and several new approvals are expected during 2023.
Finally, I wish readers and investors a happy new year. It has been a pleasure to meet many of you during recent investor events in Stockholm, Gothenburg and Lund. Investor presentations are available at our homepage and Redeye initiated coverage of Newbury Pharmaceuticals.
Newbury is positioned for a strong and exciting 2023.
