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Xspray Pharma
Annual Report • Feb 12, 2025
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Annual Report
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Interim Report October – December 2024
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Key figures, Group
| Q4 | Jan-Dec | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Net sales (SEK thousand) | - | - | - | - |
| Loss before Income tax (SEK thousand) | -82,002 | -54,513 | -285,674 | -179,684 |
| Earnings per share before dilution (SEK) | -2.36 | -1.85 | -8.62 | -6.76 |
| Earnings per share after dilution (SEK) | -2.36 | -1.85 | -8.62 | -6.76 |
| Research and development expenses as % of | 12% | 22% | 27% | 19% |
| operating expenses* | ||||
| Cash and cash equivalents (SEK thousand) | 208,236 | 166,303 | 208,236 | 166,303 |
| Total assets (SEK thousand) | 796,344 | 765,263 | 796,344 | 765,263 |
| Equity/assets ratio (%) | 78% | 91% | 78% | 91% |
| Average number of employees | 26 | 26 | 25 | 26 |
*Definitions of key figures, p. 22
October – December 2024, Group
- Net sales amounted to SEK 0 thousand (0)
- Loss before tax amounted to SEK -82,002 thousand (-54,513)
- Earnings per share before dilution amounted to SEK -2.36 (-1.85)
- Cash flow from operating activities amounted to SEK -61,601 thousand (-32,626)
- Cash flow from investing activities amounted to SEK -19,202 thousand (-20,729)
Amounts in parentheses refer to the year-earlier period.
January – December 2024, Group
- Net sales amounted to SEK 0 thousand (0)
- Loss before tax amounted to SEK -285,523 thousand (-179,684)
- Earnings per share before dilution amounted to SEK -8.62 (-6.76)
- Cash flow from operating activities amounted to SEK -222,367 thousand (-203,275)
- Cash flow from investing activities amounted to SEK -42,142 thousand (-65,876)
Amounts in parentheses refer to the year-earlier period.
Significant events during the quarter
- In October, Xspray Pharma published the composition of its Nomination Committee for the Annual General Meeting on May 13, 2025. The Nomination Committee, which has been appointed in accordance with the principles adopted by the Annual General Meeting on May 21, 2024, consists of: Thomas Eldered, appointed by Flerie AB, Chairman of the Nomination Committee; Johan Gyllenswärd, appointed by Ribbskottet AB; Mattias Klintemar, appointed by the Foundation for Baltic and East European Studies; Johan Wadell, appointed by AP2; and Anders Ekblom, Chairman of the Board of Directors, Xspray Pharma AB.
- In November, the Board of Directors, by virtue of the authorization from the Annual General Meeting on May 21, 2024, resolved to carry out a new issue of shares of approximately SEK 135 million, with preferential rights for the company's existing shareholders. The final outcome, which was announced in December, showed that the rights issue was oversubscribed and that the total number of shares increased by 3,376,226 to a total of 37,138,491. Furthermore, the Board resolved to take a loan of SEK 100 million and issue warrants to the lenders. The primary purpose of the loan is to finance the preparatory activities ahead of the contemplated launch of Dasynoc® in the US market, conduct registrationbased studies for XS003 nilotinib, and continue development of the rest of the company's product portfolio.
Significant events after the end of the reporting period
- In January, Xspray Pharma provided an update regarding the process for submitting an updated application to the US Food and Drug Administration (FDA) for Dasynoc®, the company's lead product candidate. The timeline has been adjusted as the result of one batch of tablets being identified as aberrant. The cause of the aberration has been identified, the batch has been remade to safeguard the stringent quality requirements and production has resumed. As a result of the turnaround times in production, the company intends to submit the updated application in the March/April timeframe.
- In January, interim data from a food interaction study with product candidate XS003 nilotinib was presented. The study shows that bioavailability remains stable and consistent regardless of food intake. These results confirm the benefits of the company's patented HyNap™ technology platform and its ability to deliver significant benefits for patients compared with existing PKI drugs.
A message from the CEO
Dear shareholders,
Significant advances and preparations
Intensive efforts with our application for market approval of Dasynoc® during the quarter have brought us closer to our goal despite the delay that arose in the final stages. We have produced batches of tablets of Dasynoc® with adjusted dosage strengths in accordance with the FDA's requests in order to reduce the risk of medication error. Unfortunately, an aberration in one batch of tablets was noticed very late. The turnaround times for producing and analyzing a new batch of tablets means a delay that is of course unwelcome but fully manageable. We are now producing the adjusted dosage strengths and intend to submit our revised application in the March/April timeframe.
If our application receives a Class 1 designation, we can expect a review period of two months, which will enable a launch as soon as the second quarter of 2025. If it receives a Class 2 designation, the FDA's processing time is six months from the date we submit our updated application, which will enable a launch during the autumn of 2025.
Focus on launch and future growth
Our work on building relationships with physicians and payors in the US continued during the quarter. Outside of this, the launch efforts and related costs are on hold.
We do not believe that our market positioning of Dasynoc® will be impacted by the new timeline. Our product candidate has important advantages, with the potential of being best in class compared with
competing products. Dasynoc® has lower variability, the same effect at a lower dosage strength, and solves the complex problem of co-medication with all types of acid reducing agents. This is possible because of our patented HyNap™ technology. With Dasynoc®, we have laid the foundation for future product candidates that are developed using the same technology platform.
Financing
Despite these challenges, we have strong support from our investors, both large and small, which we are grateful for. During the period, financing that encompassed a new share issue of SEK 135 million and a loan of SEK 100 million was successfully completed. Our cost profile is flexible, and largely connected with the launch itself. We believe that we have the financing we need to cover the company's capital requirements until Dasynoc® is approved, regardless of which response period the FDA uses, and to complete the remaining studies for XS003 nilotinib.
Earnings for the quarter are lower compared to the year-earlier period. One reason is a higher share of research and development costs now being expensed directly instead of being capitalized, and another is previous investments for production capacity in Malta being written off due to new timelines and changed patent situation.
The technology platform: advantages and outlook
After the quarter, we presented interim data from a food interaction study for our product candidate XS003 nilotinib. The data confirms the ability of the company's HyNap™ technology platform to deliver significant benefits for patients compared with existing PKI drugs. Our amorphous formulation of nilotinib eliminates the problems with food interaction, thus demonstrating a markedly improved profile compared with all currently approved nilotinib products. This would improve patient quality of life and reduce the risk of serious side effects.
The findings of the current study, together with the product candidate's robust patent protection, provide unique competitive advantages that would enable XS003 nilotinib to capture significant market shares.
There are exciting times ahead, and I look forward to leading Xspray Pharma through the next stage of the journey toward becoming a commercial-stage, profitable pharmaceutical company and beginning to build a position as a leading player in improved protein kinase inhibitors.
Per Andersson, CEO, Xspray Pharma
About Xspray Pharma
Xspray Pharma AB (publ) is a pharmaceutical company with a number of product candidates under clinical development, and is nearing the launch of its first product, Dasynoc®. Xspray Pharma uses its innovative, patented HyNap technology to develop improved versions of protein kinase inhibitors (PKIs) for the treatment of cancer. This segment is the largest in the field of oncology, with just over 80 approved drugs in the US at the end of 2024.
Vision
Xspray Pharma's goal is to be a leader in developing improved PKIs for the treatment of cancer. The company's financial and operational vision through 2030:
- Net sales that exceed USD 400 million
- Profit margin that exceeds 65% (profit before tax)
- Five products launched
- Three product candidates under development
Launch of the company's first commercial product – Dasynoc
In January 2025, the company issued an updated timeline for the regulatory process of obtaining market approval for Dasynoc® in the US. In July 2024, the FDA requested, in a Complete Response Letter, supplementary information to support the company's application. The company's original plan was to submit a response in the fourth quarter of 2024, but a batch of tablets was identified as being aberrant while the response was being compiled. The cause of the aberration was identified, the batch was remade to safeguard the stringent quality requirements and production has now been resumed. The company intends to submit its updated application in March or April, 2025. The FDA will subsequently assign a Prescription Drug User Free Act (PDUFA) date either two or six months after submission of the application. The PDUFA date relates to the FDA's target date for concluding the approval process for Dasynoc®.
Xspray Pharma has a partnership agreement with EVERSANA that provides access to a cost-effective sales organization for the US market. EVERSANA will provide Xspray Pharma with services in market access, a medical sales organization, and patient support programs. EVERSANA has experts with extensive experience in selling PKI drugs and interact with physicians, insurance companies, and other players that Xspray Pharma will be targeting. This will create good conditions for a rapid launch of Dasynoc®. Xspray Pharma will retain financial and strategic control but grants EVERSANA the commercial right to provide support in the launch of Dasynoc® in the US. At present, EVERSANA's market preparation activities have been limited pending the FDA's final approval.
Xspray Pharma has conducted a number of market surveys in the US. These confirmed the company's view of the potential of Dasynoc®.
Market
Protein kinase inhibitors (PKIs) have become one of the most effective treatments of cancer and for certain types of cancer, PKIs are one of only a few available options. PKIs are the largest segment in the oncology area, with over 1,800 ongoing clinical studies in Phase II or Phase III, and just over 80 PKIs are approved treatments on the US market. All Xspray Pharma's product candidates in development are currently PKIs.
Product candidates
Xspray Pharma's pipeline contains four announced product candidates. They are all based on the company's HyNap technology: Dasynoc®, XS003 nilotinib, XS008 axitinib and XS025 cabozantinib. These product candidates are stable amorphous and non-crystalline versions of the four best-selling cancer drugs Sprycel® (dasatinib), Tasigna® (nilotinib), Inlyta® (axitinib) and Cabometyx® (cabozantinib). Many protein kinase inhibitors in the market are difficult to dissolve and often have a high degree of variability in uptake. Xspray's amorphous formulation increases solubility, which leads to more stable uptake and permits lower dosages to be administered to patients with retained efficacy. The total annual sales of the original drugs Sprycel®, Tasigna® Inlyta® and Cabometyx® for 2023 exceeded USD 5.2 billion in the US market and USD 7.1 billion globally.1
1 The information regarding annual sales has been taken from the reference
companies' quarterly reports.
Overview – product candidates
| Product candidate | Patent | Development phase | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Project | Substance | Indication | Regulatory path |
Substance patent expiry |
Secondary patent expiry |
New candidate evaluation |
Developmen t of formulation |
Pilot studies |
Pivotal studies | Regulatory review |
Original product/Com pany |
| Dasynoc | dasatinib | Leukemia (CML, ALL) |
505(b)(2) | Dec 2020 | Sep 2026 | Sprycel®/ BMS |
|||||
| XS003 | nilotinib | Leukemia (CML) |
505(b)(2) | Jan 2024 | Oct 2032 | Tasigna®/ Novartis |
|||||
| XS008 | axitinib | Renal cancer (RCC) |
505(b)(2) | Apr 2025 | Dec 2030 | Inlyta®/ Pfizer |
|||||
| XS025 | cabozantinib | Renal cancer (RCC) |
505(b)(2) | Aug 2026 | Jul 2033 | Cabometyx ®/ Exelixis |
Share information
Xspray Pharma's share is listed on Nasdaq Stockholm in the Small Cap segment under the symbol XSPRAY. The number of shares in the company at December 31, 2024 was 37,138,491 and the closing price on that date was SEK 41.45.
| Owners as of December 31, 2024 |
Number of shares |
Share of capital & votes |
||
|---|---|---|---|---|
| Flerie Invest | 6,501,261 | 17.51% | ||
| Anders Bladh (private & Ribbskottet) |
4,574,670 | 12.32% | ||
| The Foundation for Baltic and East European Studies |
4,342,626 | 11.69% | ||
| Fourth Swedish National Pension Fund |
3,710,135 | 9.99% | ||
| Avanza Pension | 1,500,322 | 4.04% | ||
| Third Swedish National Pension Fund |
1,429,998 | 3.85% | ||
| Unionen | 1,418,634 | 3.82% | ||
| Second Swedish National Pension Fund |
1,140,920 | 3.07% | ||
| Nordnet Pension Insurance | 844,601 | 2.27% | ||
| Carl Erik Norman | 793,878 | 2.14% | ||
| Total, 10 largest owners | 26,257,045 | 70.70% | ||
| Other shareholders | 10,881,446 | 29.30% | ||
| Total | 37,138,491 | 100.0% |
| Financial calendar | |||
|---|---|---|---|
| Annual Report 2024 | March 27, 2025 | ||
| Interim Report Q1 2025 | May 8, 2025 | ||
| 2025 Annual General Meeting |
May 13, 2025 | ||
| Interim Report Q2 2025 | August 6, 2025 | ||
| Interim Report Q3 2025 | November 5, 2025 |
The financial reports are available on the Xspray Pharma website, www.xspraypharma.com.
Analysts monitoring the company
Filip Einarsson, Redeye AB
Dan Akschuti, Pareto Securities AB
Share price performance
Financial performance
Unless otherwise indicated, the comments below pertain to the Group. Comparison figures are presented in parentheses and pertain to the same period in 2023. The Group comprises the Parent Company, a dormant subsidiary and a US subsidiary. The consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards (IFRS) and the Parent Company's statements have been prepared in accordance with RFR2.
Net sales
Net sales for the company amounted to SEK 0 thousand. Sales are expected to increase when the company launches its initial product, Dasynoc®, in the US market. Further information on Dasynoc® is available on pages 6–7.
Other operating income
Other operating income was SEK 167 thousand (1,304) for the fourth quarter and SEK 2,096 thousand (31,767) for the January–December period. The change for the full year compared with the preceding period is due to the comparative period being impacted by a one-time effect of SEK 29,671 thousand attributable to the legal proceedings in the US that concluded in September 2023. Other operating income primarily consists of exchange rate gains arising in conjunction with payments abroad and translations of the currency account.
Research and development costs
Total expenditures for research and development for the quarter amounted to SEK -30,173 thousand (-25,863), of which SEK -9,914 thousand (-12,488) was recognized as an expense in profit or loss and SEK -20,259 thousand (-13,375) was capitalized as development expenses and is presented in the company's balance sheet. For the full year, the figure is SEK -121,504 thousand (-91,442) for total expenditure for research and development, with SEK -79,358 thousand (-40,259) being expensed and SEK -42,146 thousand (-51,183) capitalized as development expenditures.
Research and development costs are attributable to Dasynoc®, XS003 nilotinib, XS008 axitinib and XS025 cabozantinib.
Administration and sales expenses
Administration and sales expenses totaled SEK -69,552 thousand (-43,988) in the fourth quarter. Of these, personnel costs amounted to SEK -7,960 thousand (-9,381). The increase in costs is attributable primarily to disposal of advance payments due to the decision not to locate the planned manufacturing facility in Malta, which was announced in a previous interim report. Apart from this non-cash item of SEK -19,701 thousand, administration and sales expenses are in line with the preceding year and for the most part comprise preparatory market activities for Dasynoc®. Administration and sales expenses for the January– December period totaled SEK -203,878 thousand (-169,567), with SEK -37,012 thousand (-36,452) pertaining to personnel costs.
Other operating expenses
Other operating expenses totaled SEK -2,577 thousand (-676) for the fourth quarter and SEK -5,901 thousand (-3,675) for the January–December period. Other operating expenses consist of exchange rate losses arising in conjunction with payments abroad and translations of the currency account.
Loss for the period
Loss for the period totaled SEK -81,968 thousand (-54,496) for the fourth quarter and SEK -285,523 thousand (-179,684) for the January–December period. This corresponds to earnings per share before dilution of SEK -2.36 (-1.85) for the fourth quarter and SEK -8.62 (-6.76) for the January– December period.
The deterioration in earnings for the quarter is due primarily to the non-cash item of SEK -19,701 thousand related to the manufacturing facility on Malta as well as increased preparatory market activities for Dasynoc®.
Cash flow
Cash flow from operating activities amounted to SEK -61,601 thousand (-32,626) in the fourth quarter, of which the effect from working capital was SEK -4,774 thousand (20,028), and totaled SEK -222,367 thousand (-203,275) for the January–December period, of which the effect from working capital was SEK 4,589 thousand (-31,581). The increase in
negative cash flow is due primarily to preparatory activities for Dasynoc®.
Cash flow from investing activities amounted to SEK -19,202 thousand (-20,729) in the fourth quarter and SEK -42,142 thousand (-65,876) for the January– December period. The item includes capitalized development expenditure of SEK -19,201 thousand (-12,760) for the fourth quarter and SEK -37,762 thousand (-49,855) for the January–December period. The decrease in cash flow from investing activities is due primarily to Dasynoc® moving from a research and development project to being prepared for launch.
Cash flow from financing activities totaled SEK 214,022 thousand (87,484) in the fourth quarter. The increase is due primarily to the completed rights issue of SEK 135,049 thousand and the loan of SEK 100,000 thousand, prior to transaction costs. Cash flow from financing activities for the January– December period was SEK 306,108 thousand (315,594). Full-year 2024 was also positively impacted by the exercise of the TO6 series of warrants.
Total cash flow was SEK 133,219 thousand (34,129) for the fourth quarter and SEK 41,599 thousand (46,443) for the January–December period. The Group had SEK 208,236 thousand (166,303) in cash and cash equivalents at December 31, 2024.
Intangible assets
Development expenditures for the projects have been capitalized according to plan. Capitalized development expenditures totaled SEK 20,259 thousand (13,375) in the fourth quarter. The Group's total capitalized expenditure for development amounted to SEK 478,926 thousand (436,780) on December 31, 2024. The item is associated with the company's product candidates Dasynoc®, XS003 nilotinib, XS008 axitinib and XS025 cabozantinib. No costs linked to Dasynoc® were capitalized in 2024 since the development phase is approaching its final stages and a launch is expected in the near-term, and therefore costs are expensed in the income statement.
Financial position
In conjunction with the rights issue during the quarter, the company raised an unsecured loan of SEK 100 million with a 12-month maturity and also issued 1,150,000 warrants to the lenders. The warrants can be redeemed for shares at various subscription prices up through November 2029.
Depending on the path and orientation the company chooses to take over the coming year, the Group's coverage of cash and cash equivalents will fall below the liquidity needed to pursue operations for the coming 12 months. The company's capital needs depend on a number of factors, including the launch timing and market uptake of the company's first product candidate, Dasynoc®, as well as the results from, and costs for, ongoing and future drug studies.
In light of this, the Board of Directors is actively engaged in evaluating the company's financial requirements and position, with various financing alternatives being reviewed. The primary scenario is that the launch of Dasynoc© will be financed through loans. The equity/assets ratio for the Group was 78.2 percent (90.6) at December 31, 2024.
Since the operation is in a pre-commercial stage without sales revenue, the Board of Directors has decided to propose to the AGM that no dividends are to be paid to shareholders in 2025.
Group structure
The Group structure comprises the Parent Company, Xspray Pharma AB (publ), corporate identity number 556649-3671, and its wholly owned subsidiaries Xspray Pharma Futurum AB, corporate identity number 559178-7642, and Xspray Pharma Inc. The two Swedish limited liability companies have their offices in Solna, Sweden, and the US subsidiary has its offices in Delaware. The address of the head office is Scheeles väg 2, SE-171 65 Solna, Sweden.
Parent Company
Operations were conducted primarily in the Parent Company, Xspray Pharma AB (publ). The Parent Company's cash and cash equivalents totaled SEK 206,682 thousand (165,658) and the equity/assets ratio was 81.3 percent (94.9) at December 31, 2024.
Employees
The organization has the same number of employees compared with the year-earlier period. The average number of employees in the Group totaled 26 (26).
Related-party transactions
The management of the Parent Company, the Boards of Directors of the Parent Company and subsidiary are defined as related parties. Purchase of services from senior executives during the year pertain to consultant fees from Glimberg Consulting AB, owned by Linda Glimberg, who is part of the company's executive management team. The company did not purchase any services from Glimberg in the fourth quarter, since Linda Glimberg
transitioned to permanent employment on June 30, 2024. The fees thus totaled SEK 0 thousand (-476) for the quarter and SEK -1,015 thousand (-1,725) for the January–December period.
The company did purchase consulting services in 2023 but not in 2024 from Stratfox Healthcare Group LLC, which is owned by the company's Board member Robert Molander. The fees thus totaled SEK 0 thousand (-107) for the fourth quarter and SEK 0 thousand (-532) for the January–December period.
Financial statements
Xspray Pharma Interim Report, Q1 2024 11
Consolidated income statement
| Q4 | Jan-Dec | ||||
|---|---|---|---|---|---|
| SEK thousand | 2024 | 2023 | 2024 | 2023 | |
| Net sales | - | - | - | - | |
| Other operating income | 167 | 1,304 | 2,096 | 31,767 | |
| Research and development expenses | -9,914 | -12,488 | -79,358 | -40,259 | |
| Administration and sales expenses | -69,552 | -43,988 | -203,878 | -169,567 | |
| Other operating expenses | -2,577 | -676 | -5,901 | -3,675 | |
| Operating loss | -81,876 | -55,848 | -287,041 | -181,734 | |
| Finance income Finance costs |
1,779 -1,905 |
1,335 - |
3,297 -1,929 |
2,725 -675 |
|
| Finance net | -126 | 1,335 | 1,368 | 2,049 | |
| Loss before Income tax Tax |
-82,002 34 |
-54,513 17 |
-285,674 151 |
-179,684 17 |
|
| Loss for the period | -81,968 | -54,496 | -285,523 | -179,667 | |
| Earnings per share for the period before dilution, SEK |
-2.36 | -1.85 | -8.62 | -6.76 | |
| Earnings per share for the period after dilution, SEK | -2.36 | -1.85 | -8.62 | -6.76 | |
| Average number of shares before dilution | 34,756,745 | 29,523,111 | 33,137,306 | 26,593,910 | |
| Average number of shares after dilution | 34,756,745 | 29,523,111 | 33,137,306 | 26,593,910 |
Consolidated statement of comprehensive income
| Q4 | Jan-Dec | ||||
|---|---|---|---|---|---|
| SEK thousand | 2024 | 2023 | 2024 | 2023 | |
| Loss for the period | -81,968 | -54,496 | -285,523 | -179,667 | |
| Annual translation differences in the | |||||
| translation of foreign operations | 75 | -184 | 205 | -184 | |
| Total comprehensive income for the period | -81,893 | -54,680 | -285,318 | -179,851 |
Profit for the period and comprehensive income are attributable in their entirety to Parent Company shareholders.
Consolidated balance sheet
| SEK thousand | 31 Dec 2024 | 31 Dec 2023 |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Intangible assets | ||
| Capitalized development costs | 478,926 | 436,780 |
| Total intangible assets | 478,926 | 436,780 |
| Property, plant and equipment | ||
| Machinery and installations | 3,565 | 8,581 |
| Right-of-use assets | 32,204 | 37,649 |
| Equipment | 2,026 | 2,056 |
| Fixed assets under construction and prepayments | 41,389 | 59,365 |
| Total Property, plant and equipment | 79,185 | 107,651 |
| Financial assets | ||
| Financial investments | 1 | 1 |
| Other long-term receivables | 3,167 | 3,016 |
| Total financial assets | 3,168 | 3,017 |
| Total non-current assets | 561,279 | 547,448 |
| Current assets | ||
| Inventories | 20,335 | 43,781 |
| Current receivables | 4,018 | 4,165 |
| Prepaid expenses and accured income | 2,476 | 3,566 |
| Cash and cash equivalents | 208,236 | 166,303 |
| Total current assets | 235,066 | 217,815 |
| TOTAL ASSETS | 796,344 | 765,263 |
Consolidated balance sheet cont.
| SEK thousand | 31 Dec 2024 | 31 Dec 2023 |
|---|---|---|
| EQUITY AND LIABILITIES | ||
| Equity | ||
| Share capital | 37,138 | 31,254 |
| Other contributed capital | 1,425,208 | 1,216,092 |
| Reserves | 997 | 792 |
| Retained earnings including profit/loss for the period | -840,247 | -554,724 |
| Total equity attributable to the Parent Company's shareholders | 623,097 | 693,413 |
| Non–current liabilities | ||
| Lease liabilities | 27,108 | 31,947 |
| Total non-current liabilities | 27,108 | 31,947 |
| Current liabilities | ||
| Short-term interest-bearing liabilities | 96,000 | - |
| Trade accounts payable | 17,083 | 12,472 |
| Lease liabilities | 5,113 | 4,861 |
| Other current liabilities | 9,312 | 6,263 |
| Accrued expenses and deferred income | 18,632 | 16,307 |
| Total current liabilities | 146,140 | 39,903 |
| TOTAL EQUITY AND LIABILITIES | 796,344 | 765,263 |
Consolidated statement of changes in equity
| SEK thousand | Other | Retained earnings | |||
|---|---|---|---|---|---|
| Share | contributed | incl. profit/loss for | Total | ||
| capital | capital | Reserves | the period | Equity | |
| Opening balance as of January 1, 2023 | 22,680 | 907,420 | 976 | -375,057 | 556,019 |
| Loss of the period | - | - | - | -179,667 | -179,667 |
| Other comprehensive income for the period | - | - | -184 | - | -184 |
| Total comprehensive income for the period | - | - | -184 | -179,667 | -179,851 |
| New share issue | 8,573 | 334,352 | - | - | 342,925 |
| Transaction costs | - | -26201 | - | - | -26,201 |
| Redemption of warrants | - | - | - | - | - |
| Warrant program | - | 522 | - | - | 522 |
| Closing balance as of December 31, 2023 | 31,253 | 1,216,093 | 792 | -554,724 | 693,414 |
| Opening balance as of January 1, 2024 | 31,253 | 1,216,093 | 792 | -554,724 | 693,414 |
|---|---|---|---|---|---|
| Loss of the period | - | - | - | -285,523 | -285,523 |
| Other comprehensive income for the period | - | - | 205 | - | 205 |
| Total comprehensive income for the period | - | - | 205 | -285,523 | -285,318 |
| New share issue | 5,885 | 229,513 | - | - | 235,398 |
| Transaction costs | - | -21,519 | - | - | -21,519 |
| Warrant program | - | 1,122 | - | - | 1,122 |
| Closing balance as of December 31, 2024 | 37,138 | 1,425,208 | 997 | -840,247 | 623,097 |
Consolidated statement of cash flow
| Q4 | Jan-Dec | |||
|---|---|---|---|---|
| SEK thousand | 2024 | 2023 | 2024 | 2023 |
| Operating activities | ||||
| Operating loss | -81,876 | -55,848 | -287,041 | -181,734 |
| Non-cash adjustments | ||||
| Depreciation | 1,661 | 2,449 | 8,547 | 9,194 |
| Unrealized currency impact | - | 41 | -32 | 41 |
| Disposal of inventory | - | - | 29,471 | - |
| Disposal of tangible fixed assets | 22,757 | 5 | 22,772 | 5 |
| Interest received | 2,238 | 1,138 | 2,240 | 1,969 |
| Interest paid | -1,607 | -439 | -2,913 | -1,169 |
| Cash flow from operating activities before changes in | -56,827 | -52,654 | -226,956 | -171,694 |
| working capital | ||||
| Changes in working capital | ||||
| Change in inventory | 376 | -778 | -6,025 | -35,229 |
| Change in operating receivables | -972 | 27,982 | 1,336 | -4,109 |
| Change in operating liabilities | -4,178 | -7,176 | 9,278 | 7,757 |
| Cash flow from operating activities | -61,601 | -32,626 | -222,367 | -203,275 |
| Investing activities | ||||
| Capitalized development costs | -19,201 | -12,760 | -37,762 | -49,855 |
| Acquisition of property, plant and equipment | -1 | -2,615 | -4,380 | -2,692 |
| Prepayments of Right-of-Use-Assets | - | -1,556 | - | -1,556 |
| Prepayments | - | -3,798 | - | -11,773 |
| Cash flow from investing activities | -19,202 | -20,729 | -42,142 | -65,876 |
| Financing activities | ||||
| New share issue | 135,049 | 92,288 | 235,398 | 297,924 |
| Loan raised | 96,000 | - | 96,000 | * 45,000 |
| Transaction costs | -15,783 | -4,611 | -21,519 | -26,201 |
| Payment of lease liability | -1,244 | -193 | -4,893 | -1,651 |
| Repurchased warrants | - | - | -64 | - |
| Allocated warrants | - | - | 1,186 | 522 |
| Cash flow from financing activities | 214,022 | 87,484 | 306,108 | 315,594 |
| Cash flow for the period | 133,219 | 34,129 | 41,599 | 46,443 |
| Cash and cash equivalents at the beginning of the period | 74,759 | 132,480 | 166,303 | 120,166 |
| Effect of exchange rate and value changes in cash and | 257 | -306 | 334 | -306 |
| cash equivalents | ||||
| Cash and cash equivalents at the end of the period | 208,236 | 166,303 | 208,236 | 166,303 |
*In addition to SEK 205,636 thousand in the set-off issue during the period, SEK 45,000 thousand was contributed from loans raised.
Parent Company income statement
| Q4 | Jan-Dec | |||
|---|---|---|---|---|
| SEK thousand | 2024 | 2023 | 2024 | 2023 |
| Net sales | - | - | - | - |
| Other operating income | -960 | 1,206 | 2,096 | 31,669 |
| Research and development expenses | -10,470 | -12,909 | -81,982 | -41,100 |
| Administration and sales expenses | -66,353 | -44,292 | -201,453 | -169,705 |
| Other operating expenses | -1,450 | -596 | -5,934 | -3,633 |
| Operating loss | -79,232 | -56,592 | -287,273 | -182,769 |
| Finance income | 1,779 | 1,061 | 2,483 | 1,664 |
| Finance costs | -1,905 | -0 | -1,929 | -675 |
| Finance net | -126 | 1,061 | 554 | 988 |
| Loss before Income tax | -79,359 | -55,530 | -286,719 | -181,781 |
| Tax | - | - | - | - |
| Loss for the period | -79,359 | -55,530 | -286,719 | -181,781 |
Parent Company balance sheet
| SEK thousand | 31 Dec 2024 | 31 Dec 2023 |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Intangible assets | ||
| Capitalized development costs | 473,481 | 435,182 |
| Total intangible assets 473,481 |
435,182 | |
| Property, plant and equipment | ||
| Machinery and installations | 3,565 | 8,581 |
| Equipment | 2,026 | 2,056 |
| Fixed assets under construction and prepayments | 41,389 | 57,156 |
| Total Property, plant and equipment | 46,980 | 67,793 |
| Financial assets | ||
| Shares in subsidiaries | 2,238 | 2,238 |
| Financial investments | 1 | 1 |
| Other long-term receivables | 2,999 | 2,999 |
| Total financial assets | 5,237 | 5,237 |
| Total non-current assets | 525,699 | 508,213 |
| Current assets | ||
| Inventories | 20,335 | 43,781 |
| Current receivables | ||
| Other current receivables | 4,299 | 4,364 |
| Prepaid expenses and accured income | 3,277 | 4,491 |
| Total current receivables | 7,576 | 8,855 |
| Cash and bank | 206,682 | 165,658 |
| Total current assets | 234,594 | 218,294 |
| TOTAL ASSETS | 760,293 | 726,507 |
Parent Company balance sheet cont.
| SEK thousand | 31 Dec 2024 | 31 Dec 2023 | |
|---|---|---|---|
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | |||
| Share capital | 37,138 | 31,254 | |
| Statutory reserve | 976 976 |
||
| Development expenditure reserve | 473,481 435,182 |
||
| Total restricted equity | 511,596 | 467,412 | |
| Non-restricted equity | |||
| Other contributed capital | 1,428,208 | 1,219,092 | |
| Accumulated earnings | -1,035,032 | -814,952 | |
| Profit/loss for the period | -286,719 | -181,781 | |
| Total non-restricted equity | 106,456 | 222,358 | |
| Total equity | 618,052 | 689,771 | |
| Current liabilities | |||
| Short-term interest-bearing liabilities | 96,000 | - | |
| Trade accounts payable | 18,296 | 14,166 | |
| Other current liabilities | 9,312 | 6,263 | |
| Accrued expenses and deferred income | 18,632 | 16,307 | |
| Total current liabilities | 142,241 | 36,736 | |
| TOTAL EQUITY AND LIABILITIES | 760,293 | 726,507 |
Parent Company statement of cash flow
| Q4 | Jan-Dec | |||
|---|---|---|---|---|
| SEK thousand | 2024 | 2023 | 2024 | 2023 |
| Operating activities | ||||
| Operating loss | -79,232 | -56,592 | -287,273 | -182,769 |
| Non-cash adjustments | ||||
| Depreciation | 913 | 1,883 | 5,476 | 7,604 |
| Disposal of inventory | - | - | 29,471 | - |
| Disposal of tangible fixed assets | 19,701 | 5 | 19,716 | 5 |
| Interest received | 2,238 | 1,926 | 2,240 | 1,969 |
| Interest paid | -1,239 | - | -1,263 | -675 |
| Cash flow from operating activities before changes in | ||||
| working capital | -57,619 | -52,778 | -231,633 | -173,866 |
| Changes in working capital | ||||
| Changes in inventory | 376 | -778 | -6,025 | -35,229 |
| Change in operating receivables | -1,169 | 26,302 | 1,279 | -4,861 |
| Change in operating liabilities | -4,307 | -5,449 | 8,837 | 9,450 |
| Cash flow from operating activities | -62,719 | -32,703 | -227,542 | -204,506 |
| Investing activities | ||||
| Purchase of intangible assets | -19,414 | -12,840 | -38,299 | -50,238 |
| Acquisition of property, plant and equipment | - | -2,616 | -4,379 | -2,693 |
| Group contributions | - | -2,188 | - | -2,188 |
| Prepayments | - | -3,798 | - | -11,773 |
| Cash flow from investing activities | -19,414 | -21,442 | -42,678 | -66,892 |
| Financing activities | ||||
| New share issue | 135,049 | 92,288 | 235,398 | 297,924 |
| Transaction costs | -15,783 | -4,611 | -21,519 | -26,201 |
| Loan raised | 96,000 | - | 96,000 | * 45,000 |
| Repurchased warrants | - | - | -64 | - |
| Allocated warrants | - | - | 1,186 | 522 |
| Cash flow from financing activities | 215,266 | 87,677 | 311,001 | 317,245 |
| Cash flow for the period | 133,133 | 33,532 | 40,781 | 45,847 |
| Cash and cash equivalents at the beginning of the period | 73,384 | 132,430 | 165,658 | 120,116 |
| Effect of exchange rate and value changes in cash and | 166 | -305 | 243 | -305 |
| cash equivalents | ||||
| Cash and cash equivalents at the end of the period | 206,682 | 165,658 | 206,682 | 165,658 |
*In addition to SEK 205,636 thousand in the set-off issue during the period, SEK 45,000 thousand was contributed from loans raised.
Notes
Note 1. Accounting and measurement policies
The interim report for the Group has been prepared in accordance with IAS 34 Interim Financial Reporting, issued by the International Accounting Standards Board (IASB) and with the applicable provisions in the Swedish Annual Accounts Act. The interim report for the Parent Company has been prepared in accordance with Chapter 9, "Interim Reports", of the Annual Accounts Act. This interim report is an outline of the company's financial performance during the period and is to be read in conjunction with the latest annual report. For the Parent Company and the Group, the same accounting policies and bases for calculation as in the Annual Report for 2023 have been applied. Comparison figures are presented in parentheses and pertain to the same period in 2023.
Note 2. Key estimates and assessments
Preparing the financial statements in accordance with IFRS requires management to make assessments and estimates, and to make assumptions that impact the application of the accounting policies and the recognized amounts of assets, liabilities, revenue and expenses. The real outcome may deviate from these estimates and assumptions. The estimates and assumptions are routinely evaluated. Changes to estimates are recognized in the period the changes are made.
The source of uncertainty in estimations that entail a significant risk for the need to significantly adjust the value of assets or liabilities during the coming financial year is the carrying amount of "Capitalized development expenditure". Determining whether the requirements for capitalization of development expenditure have been met requires both initial and routine assessments. The capitalized expenditures are regularly tested as to whether they could be exposed to a decrease in value. The company holds capitalized intangible assets that have not yet been completed and are impairment tested either yearly or as soon as there is an indication of a potential decrease in value. Impairment tests involve estimates of future cash flows attributable to the asset or the cash-generating unit to which the asset relates when it is complete. These estimates and judgments involve expectations primarily regarding the selling price of products, market penetration, remaining development, sales and marketing expenses, and the likelihood that the product passes through the remaining development phases. The assumptions involve industry- and market-specific data produced by corporate management and reviewed by the Board of Directors.
Material risks and uncertainties
Xspray Pharma's operation is associated with both industry-related and company-specific risks. The company develops product candidates, and there will always be regulatory, market-related and financial risks in the operation. No material changes have occurred in the risks and uncertainties during the period compared with those the company reported in the Annual Report for 2023.
Financing risk and going concern
Depending on the path and orientation the company chooses to take over the coming year, the Group's coverage of cash and cash equivalents will fall below the liquidity needed to pursue operations for the coming 12 months. The company's capital needs depend on a number of factors, including the launch timing and market uptake of the company's first product candidate, Dasynoc, as well as the results from, and costs for, ongoing and future drug studies.
In light of this, the Board of Directors is actively engaged in evaluating the company's financial requirements and position, with various financing alternatives being reviewed. The primary scenario is that the launch of Dasynoc© will be financed through loans. If the financing secured is not sufficient, it would suggest material uncertainties that could lead to significant doubt regarding the company's capacity to continue its operations. In accordance with the policy by the Board, the Group must maintain a strong financial position, which will help the company retain investor and market confidence. It also creates a foundation for further development of company operations, with continued long-term support for its goal of securing returns for the company's owners. Until the company has achieved long-term, sustainable profitability, its policy is to maintain a low level of debt and a high level of equity.
Definitions of key performance indicators
Earnings per share are calculated as earnings for the period divided by the average number of shares during the period. The equity/assets ratio is equity as a percentage of the balance sheet total. Research and development costs as a percentage of operating expenses equate to expensed research and development expenses divided by operating expenses. Total operating expenses consist of operating profit less net sales and other operating income. The carrying amount of receivables, cash and cash equivalents, trade payables and other liabilities constitute a reasonable approximation of fair value.
Assurance from the Board
The Board of Directors and the CEO declare that this quarterly report provides a true and fair overview of the Group's and Parent Company's business operations, financial position and performance and describes principal risks and uncertainties faced by the company.
Solna, February 12, 2025
Anders Ekblom Chairman
Board member Board member
Anders Bladh Robert Molander
Maris Hartmanis Torbjörn Koivisto Board member Board member
Christine Lind Carl-Johan Spak Board member Board member
Per Andersson CEO
This report has not been reviewed by the company's auditors.
Glossary
| 505(b)(2) NDA | Application for drug approval in the US for an improved version of an existing licensed or approved drug. |
|---|---|
| Amorphous | An amorphous structure is a chemical term that describes substances whose molecules lack an ordered structure. |
| Bioequivalence | Term used to describe whether two different drugs are processed in a similar manner by the body and are thereby expected to have a similar and equivalent medicinal effect. If it can be confirmed that two drugs being compared are bioequivalent, they can be expected to have the same effect and safety. |
| Bioavailability | (Biological availability), a concept in pharmacology that shows how large a portion of the drug reaches the blood. |
| FDA | Food and Drug Administration. The US food and drug authority responsible for foodstuffs, nutritional supplements, drugs, cosmetics, medical equipment, radiation-emitting equipment and blood products. |
| Crystalline | A crystalline structure is a chemical term that describes an ordered structure among the molecules of the substance. |
| PDUFA date | The FDA's target date for concluding the approval process for a drug application. |
| Pilot study | A study conducted on a smaller scale than a full study. A pilot study can be used both to check whether the arrangement of the study is a functional one, and to collect data that can later be used as control values in the full study. |
| Pivotal study | A standard study, the results of which can be used in the registration application for approval from a medical products authority. |
| Protein kinase inhibitor (PKI) |
Drugs that block protein kinases. Protein kinase inhibitors work by blocking activity in enzymes that push the development and growth of cancer cells. |
| Proton-pump inhibitor (PPI) |
A proton-pump inhibitor is a group of drugs whose primary effect is a clear and long-lasting decrease in the production of gastric acid. |
| Tyrosine kinase inhibitor |
Tyrosine kinase inhibitors are a subgroup of protein kinase inhibitors. This cancer drug group blocks growth-stimulating signals within the cells. |
| (TKI) Variability |
The scope of the distribution in the form of many or few low and high values around the average value as regards the body's uptake of drugs. |
For more information, please contact:
Per Andersson, CEO Tel: +46 (0) 8 730 37 00 E-mail: [email protected] www.xspraypharma.com
