Xspray Pharma publishes interim report Q3, January – September 2021

Regulatory press release 2021-10-26

"Since the company's start, the business's focus and communication has been on generic and improved versions of PKIs. Going forward we have, after the end of the reporting period, decided to focus entirely on improved PKIs. In recent years, the value of generics in our models has gradually decreased, while the value of improved drugs has instead increased. This is a very important decision that will significantly simplify and streamline the development of new product candidates and lead to increased focus for the entire organization,” says Per Andersson, CEO Xspray Pharma.

Significant events during the third quarter

July – September 2021

  • In July, Xspray Pharma announced that bioequivalence had been achieved compared with the reference product in the bioequivalence study with the company’s improved version of dasatinib, HyNap-Dasa 505(b)(2), which now goes under the name Dasynoc™.
  • In August, bioequivalence studies were conducted with the company’s generic version of dasatinib, HyNap-Dasa ANDA C. The studies were conducted in two groups of healthy volunteers under fed and fasting conditions.

Significant events after the end of the reporting period

  • In October, it was announced that bioequivalence had not been achieved for HyNap-Dasa ANDA, and that the company chooses that further development of the generic version will be terminated and instead focusing on the improved product HyNap-Dasa 505(b)(2), Dasynoc™, which demonstrated bioequivalence in previous studies. The disposals of the capitalized development expenses attributable to the generic version will impact earnings in the fourth quarter. The estimated total of the effect is SEK -31 million.
  • In October, the composition of the Nomination Committee for the 2022 Annual General Meeting was announced.
  • In October, the company announced that the report for the third quarter had been brought forward from November 4, 2021, to October 26, 2021.

July – September 2021, Group

  • Net sales amounted to SEK 0 thousand (0)
  • Loss before tax amounted to SEK -13,890 thousand (-11,560)
  • Earnings per share before dilution amounted to SEK -0.73 (-0.69)
  • Cash flow from operating activities amounted to SEK -16,524 thousand (-12,764)
  • Cash flow from investing activities amounted to SEK -20,086 thousand (-19,868)

January – September 2021, Group

  • Net sales amounted to SEK 0 thousand (0)
  • Loss before tax amounted to SEK -44,754 thousand (-37,438)
  • Earnings per share before dilution amounted to SEK -2.35 (-2.23)
  • Cash flow from operating activities amounted to SEK -41,327 thousand (-36,076)
  • Cash flow from investing activities amounted to SEK -72,127 thousand (-68,901)
  • Cash and cash equivalents at the end of the period amounted to SEK 216,543 thousand (116,622)

Amounts in parentheses refer to the year-earlier period.

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