Interim Report Second Quarter 2022

Regulatory press release 2022-08-05

A vision to improve patients’ lives

Second quarter 2022 (April–June), Group
· Net sales amounted to SEK 0 thousand (0)
· Loss before tax amounted to SEK -28,865 thousand (-16,952)
· Earnings per share before dilution amounted to SEK -1.40 (-0.89)
· Cash flow from operating activities amounted to SEK -24,472 thousand (-12,831)
· Cash flow from investing activities amounted to SEK -29,197 thousand (-26,854)
 
First and second quarters (January–June), Group
· Net sales amounted to SEK 0 thousand (0)
· Loss before tax amounted to SEK -47,799 thousand (-30,863)
· Earnings per share before dilution amounted to SEK -2.31 (-1.62)
· Cash flow from operating activities amounted to SEK -52,085 thousand (-24,802)
· Cash flow from investing activities amounted to SEK -76,738 thousand (-52,042)
· Cash and cash equivalents at the end of the period amount-ed to SEK 142,581 thousand (253,737)
 
Significant events during the quarter
· In May, the Annual General Meeting resolved, in accordance with the Nomination Committee’s proposal, on the re-election of Board members Anders Ekblom, Anders Bladh, Maris Hartmanis, Torbjörn Koivisto, Christine Lind and Carl-Johan Spak as well as the election of new Board member Robert Molander for the period up until the end of the next Annual General Meeting. Anders Ekblom was elected Chairman of the Board. Gunnar Gårdemyr declined re-election.
· In June, it was announced that the company’s new long-term incentive program had been fully subscribed. The program, LTIP 2022-2025, which was offered to all employees including senior executives, consists of both warrants and employee stock options.
· In June, the company announced that it had appointed Thomas Walz as Chief Medical Officer. Thomas will take up the new position on September 1, 2022 and will become part of the company’s management team.
· In June, it was announced that the US Food and Drug Administration (FDA) had granted XS004 dasatinib orphan drug designation for the treatment of chronic myeloid leukemia (CML).
· In June, Xspray Pharma supplemented its applications to the FDA for XS004 dasatinib with the lower dosages. As a result of and in line with expectations, the originator supplemented its previous litigation with a new application for the lower dosages.
 
Significant events after the end of the reporting period
· At the beginning of August, BMS added one additional patent relating to crystalline compounds, to the ongoing XS004 litigation. BMS has previously asserted this patent in similar cases, and it was therefore not unexpected. Xspray Pharma has not applied for FDA approval to market a product that would infringe the patent in question. Accordingly, Xspray Pharma remains confident it will prevail in this litigation and does not expect the addition of this patent to change the current timeline of the case.
 
· “Even though Xspray´s journey is a long one purely in terms of time, we would like to try to provide an idea of what we see ahead of us. That is why we are shaping a vision of what Xspray will look like at the end of this decade. Based on this, we foresee that we will initially be working intensively with two products on the market in the next coming years, evolving to five products on the market by the end of the decade with an additional three in the product candidate portfolio on the way out to the market. Furthermore, we anticipate that the product candidate portfolio has the potential to generate an excess of USD 250 million in annual revenue, as well as an operating margin for the company that could exceed 40 percent.” – Per Andersson CEO