Nasdaq Nordic · interim-report
Kvartalsrapport Q1 2025
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Omsättning
- INTERIM REPORT, Q1 2025 | Momentum across key markets with 161 % sales | growth year over year, Japan partnership
- JANUARY-MARCH | • Net sales amounted to SEK 13.3 (5.1) million | • Operating profit amounted to SEK -59.8 (-65.7)
- Sales in the first quarter of 2025 | amounted to SEK 13.3 million,
- our reported figures) and seasonal | effects during which Pepaxti sales | are inhibited, Oncopeptides delivered
- quarter. Measured in number of sold | vials, sales growth was even higher. | Ongoing strategic initiatives have
- unlocked at a hospital level and | better-than-expected sales | continuing into the second quarter.
- on accelerating market penetration | and sales growth. We continue to | see growth in both Germany and
- company into a biotech company | with growing sales across several | markets and an innovative pipeline
Resultat per aktie
- million | • Earnings per share, before and after dilution | -0.29 (-0.75) SEK
- 60.7 (-67.7) million. This corresponds to | earnings per share for the quarter of SEK - | 0.29 (-0.75).
- 3) For more information, please see the notice to the Annual General Meeting 2024. | 4) Earnings per share before dilution are calculated by dividing earnings attributable to shareholders of the Parent Company by a weighted average number of | outstanding shares during the period. There is no dilution effect driven by the employee stock option program, as earnings for the periods have been negative.
Kassaflöde
- 0.29 (-0.75). | CASH FLOW, INVESTMENTS AND | FINANCIAL POSITION
Likvida medel
- -0.29 (-0.75) SEK | • Cash and cash equivalents at the end of the | period amounted to SEK 107.3 (104.8) million
- alternative avenues of financing to | ensure our cash position. We remain | financially disciplined and proactive,
Antal anställda
- solutions. | EMPLOYEES | At the end of the quarter, the number of
- At the end of the quarter, the number of | employees amounted to 75 (62). | PARENT COMPANY
- programs that include the management team, certain Board members, | founders and employees. | Program
Bruttomarginal
- operating expenses, %, | • Gross margin, TSEK, %. | The company believes that these
Fulltext
===== SIDA 1 ===== Significant events Financialoverview 1 INTERIM REPORT, Q1 2025 Momentum across key markets with 161 % sales growth year over year, Japan partnership negotiations progressing, and future U.S. prospects reignited Selected Key Indicators ONCOPEPTIDES | INTERIM REPORT Q1 2025 This publication is a translation of the original Swedish text. In the event of inconsistency or discrepancy between the Swedish version and this publication, the Swedish language version shall prevail. JANUARY-MARCH • Net sales amounted to SEK 13.3 (5.1) million • Operating profit amounted to SEK -59.8 (-65.7) million • Profit after tax amounted to SEK -60.7 (-67.7) million • Earnings per share, before and after dilution -0.29 (-0.75) SEK • Cash and cash equivalents at the end of the period amounted to SEK 107.3 (104.8) million Events after the period JANUARY-MARCH • Oncopeptides announces that the positive reimbursement decision for Pepaxti has been officially published in Italy, the final regulatory step for the drug´s upcoming commercialization in Italy. • Oncopeptides announces the first order from an Italian hospital. • Ulf Jungnelius informs the Board of Directors of his decision to step down from the Board. • Oncopeptides announces that a new real-world study on Pepaxti by Dana-Farber Cancer Institute has been published in the European Journal of Haematology confirming an overall response rate of 55 percent and safety profile with primarily manageable hematologic toxicities. • Oncopeptides announces that the U.S. FDA has lifted the clinical hold previously placed on Oncopeptides’ next-generation drug OPD5 • Oncopeptides announces the publication of new real-world data that further support the effectiveness and tolerability of Pepaxti in patients with relapsed, refractory multiple myeloma. The data were presented in an abstract from the University of Catania, Italy. ===== SIDA 2 ===== 2ONCOPEPTIDES | INTERIM REPORT Q1 2025 CEO Statement Sales in the first quarter of 2025 amounted to SEK 13.3 million, compared to SEK 5.1 million in Q1 of last year and SEK 9.9 million in the previous quarter. Despite macroeconomic uncertainty leading to a strengthened Swedish krona versus the euro (negatively impacting our reported figures) and seasonal effects during which Pepaxti sales are inhibited, Oncopeptides delivered a continued high growth of 161 percent compared to Q1 2024 and 34 percent compared to the previous quarter. Measured in number of sold vials, sales growth was even higher. Ongoing strategic initiatives have advanced positively during the quarter, and the potential partnership in Japan communicated last quarter would significantly bolster our financial position. We will communicate the outcome of these discussions as soon as they conclude. As a contingency measure, Oncopeptides continues to explore alternative avenues of financing to ensure our cash position. We remain financially disciplined and proactive, supporting our continued ambition to reach cash flow positivity by the end of 2026. Following the positive reimbursement decision in Italy, we secured our first orders in the country during Q1, ahead of plan. While it is still early days, we are off to a promising start in Italy, with approx. 70 percent of regions already unlocked at a hospital level and better-than-expected sales continuing into the second quarter. With Pepaxti now available in all our prioritized European markets, our commercial teams are fully focused on accelerating market penetration and sales growth. We continue to see growth in both Germany and Spain. In early 2025, researchers from the Dana-Farber Cancer Institute published new data confirming Pepaxti’s strong effectiveness and tolerability in relapsed, refractory multiple myeloma with an overall response rate (ORR) of 55 percent and a confirmed safety profile with primarily manageable hematologic toxicities. Additional real-world results were also published from the University of Catania in Italy and from the La Fe Hospital in Spain. Together, these findings reinforce Pepaxti’s clinical value and strengthen its position as a complement to immunotherapy and a differentiated treatment option. Beyond commercial execution, we also progressed our efforts to develop our pipeline. The U.S. Food and Drug Administration’s (FDA) decision to lift the clinical hold on OPD5 unlocks new potential for Oncopeptides to return to the U.S. market with a next-generation peptide-drug conjugate (PDC), expanding our future addressable market and strengthening our intellectual property position. While commercialization remains some way off, OPD5 is an asset with significant potential. We continue to evaluate the next steps for it and our other pipeline assets, including partnerships. Oncopeptides this year celebrate 25 years of innovation. Over the last quarter of a century, Oncopeptides has developed from a research company into a biotech company with growing sales across several markets and an innovative pipeline that holds promise. We look forward to continuing to create value for patients, partners, and shareholders in the quarters ahead. Stockholm, May 15, 2025 Sofia Heigis CEO The first quarter of 2025 marks an encouraging start to the year for Oncopeptides, with 161 percent growth in net sales versus the same period last year and 34 percent compared to the previous quarter. This reflects the early impact of our expanded commercial footprint, now including all our key European markets: Germany, Spain and Italy. During the quarter, we also made progress in our partnership negotiations in Japan and took significant steps to advance our pipeline asset OPD5. ===== SIDA 3 ===== Financial Overview 3 REVENUE Net sales of Pepaxti during the quarter were SEK 13.3 (5.1) million. The turnover for the quarter refers to Europe only. GROSS PROFIT The gross profit for the quarter amounted to SEK 13.4 (4.8) million. The gross profit was positively affected by inventory adjustments of SEK 0.2 million. OPERATING EXPENSES Operating expenses for the quarter, excluding cost of goods sold, amounted to SEK 73.2 (70.5) million. RESEARCH AND DEVELOPMENT EXPENSES Research and development costs amounted to SEK 28.7 (28.2) million for the quarter. No clinical studies are currently ongoing, where the phase three study Ocean was completed during the third quarter of 2023. MARKETING AND SALES EXPENSES Marketing and sales costs amounted to SEK 28.5 (27.7) million for the quarter. The increased costs relate to ongoing commercialization activities in Europe, focusing on Germany, Spain and Italy. GENERAL AND ADMINISTRATIVE EXPENSES Administrative costs during the quarter amounted to SEK 16.8 (17.9). EXPENSES FOR SHARE BASED INCENTIVE PROGRAMS For the quarter, costs, including social security contributions, for share-related incentive programs amounted to SEK 0.8 (2.7) million. The cost does not affect cash flow in the period. See note 8. TAX AND EARNINGS Profit during the quarter amounted to SEK - 60.7 (-67.7) million. This corresponds to earnings per share for the quarter of SEK - 0.29 (-0.75). CASH FLOW, INVESTMENTS AND FINANCIAL POSITION Cash flow from operating activities amounted to SEK -68.3 (-67.4) million for the quarter. The company has during the quarter secured a short-term credit facility amounting to SEK 20 million, to be drawn at the discretion of the company. Oncopeptides has loan agreement with the European Investment Bank (EIB). The agreement provides Oncopeptides with access to a loan facility of up to EUR 30 million without collateral. The loan agreement is divided into three parts, tranches, each with a maturity of 5 years, which will be available if the company meets certain conditions. In the second quarter of 2023, Oncopeptides used tranche A of this loan facility, which provided the company with EUR 10 million in cash. As of the reporting date, the company does not fully meet an equity condition meaning that tranche B and C are currently not available. Equity in the group amounted to SEK -5.8 (- 8.4) million at the end of the period. Equity for the parent company amounted to SEK 458.4 (75.5) million. GOING CONCERN The financial statements have been prepared on the assumption that the company has the ability to continue operations for the coming 12-month period, in line with the going concern principle. In order for existing liquidity to cover the coming 12-month period, sales growth needs to follow plan and ongoing licensing deals in Asia need to be concluded. Should crucial conditions not be met, for example by sales not developing at the rate assumed, there is a risk regarding the continued operation of the Group. This means that there are circumstances that may give rise to significant doubts regarding the company's ability to continue operations without additional liquidity being provided to the parent company within the coming 12- month period. The Board of Directors and CEO assess that there are several alternatives with good prospects for obtaining additional liquidity within the coming 12-month period. The alternatives include, among other things, licensing revenues through partnerships for individual markets and various types of financing solutions. EMPLOYEES At the end of the quarter, the number of employees amounted to 75 (62). PARENT COMPANY The operations of the parent company correspond in all essential respects with the operations of the group, which is why the comments for the group also apply to the parent company. ONCOPEPTIDES SHARE At the end of the period, the number of registered shares eligible for trading and votes in Oncopeptides amounted to 225,758,823, inclusive of 14,494,920 C- shares held by the company. AUDITOR REVIEW This report has not been reviewed by the company’s auditors. ONCOPEPTIDES | INTERIM REPORT Q1 2025 ===== SIDA 4 ===== Signatures 4ONCOPEPTIDES | INTERIM REPORT Q1 2025 The Board and the CEO confirm that the interim report provides a true and fair reflection of the Group’s and the Parent Company’s operations, position and earnings and describes the material risks and uncertainty factors faced by the Parent Company and the companies within the Group. Stockholm, May 15, 2025 Per Wold-Olsen Sofia Heigis Chairman CEO Jennifer Jackson Board member Cecilia Daun-Wennborg Board member Per Samuelsson Board member Brian Stuglik Board member ===== SIDA 5 ===== Condensed consolidated statement of comprehensive income 5 Condensed consolidated statement of financial position ONCOPEPTIDES | INTERIM REPORT Q1 2025 ===== SIDA 6 ===== Condensed consolidated statement of changes in equity Condensed consolidated statement of cash flow 6ONCOPEPTIDES | INTERIM REPORT Q1 2025 ===== SIDA 7 ===== Condensed Parent Company income statement Condensed Parent Company balance sheet 7 Condensed Parent Company statement of comprehensive income ONCOPEPTIDES | INTERIM REPORT Q1 2025 ===== SIDA 8 ===== NOTE 1 - GENERAL INFORMATION This interim report covers the Swedish parent company Oncopeptides AB (publ), registration number 556596 -6438, as well as the wholly owned subsidiaries Oncopeptides Incentive AB, Oncopeptides Innovation AB (with the wholly owned subsidiary Oncopeptides Innovation 1 AB), Oncopeptides GmbH and Oncopeptides Srl and Oncopeptides SL . The parent company is a public limited company based in Stockholm. The figures in brackets in the report refer to the corresponding period of the previous year. The interim report has been approved for publication on 15 May 2025. NOTE 2 - ACCOUNTING PRINCIPLES The group’s interim report is prepared in accordance with IAS 34. The parent company applies the Swedish Financial Reporting Council's recommendation RFR 2. Oncopeptides applies, other than what appears below, the same accounting principles as in the most recent annual report. Significant accounting and valuation principles can be found on pages 43-48 of the annual report for 2024. No new or changed standards have been introduced since 1 January 2025 that have had any significant impact on the company's financial reporting. Oncopeptides applies ESMA's (European Securities and Markets Authority) guidelines for alternative key figures. NOTE 3 - RISKS AND UNCERTAINTIES In its operations, Oncopeptides is exposed to a number of risks. The company continuously evaluates known and predictable risks and acts to minimize the effect of these risks within the framework of the company's business strategy and safeguarding the company's long -term interests, including its sustainability. The company assesses that the risks described in the annual report for 2024 remain during the period. NOTE 4 - ESTIMATES AND CONSIDERATIONS This report contains forward-looking statements. Actual results may differ from those stated. Internal factors such as successful management of research programs and intellectual property rights may affect future results. The interim report has been prepared with the assumption that the company has the ability to continue operations during the next 12-month period, in line with the going concern principle. NOTE 5 - REVENUE RECOGNITION There has been no change in the principle of revenue recognition compared to the annual report 2024. Revenue is recognized at the transaction price for goods sold excluding value added tax, discounts and returns. Revenue is recognized at the time of delivery when Oncopeptides has fulfilled its performance commitment and control of the goods passes to the customer. The customers are defined as hospitals and/or clinics and retailers who sell the goods to the final user of the goods. As the final price is related to the discount that applies in the respective local market the parent company and the group report a liability for a calculated discount based on the frameworks for discounts that apply in each market. The provision for estimated discounts is reported under the heading Other short-term liabilities in the balance sheet. NOTE 6 – LOANS FROM CREDIT INSTITUTIONS The liability relate to a loan from EIB. It will not be amortized until the 16 th of June 2028, when it will be fully repaid. The interest is accumulated and capitalized during the term and paid in connection to the repayment of the loan. The contractual interest rate is 7% for the full term. The effective interest rate is estimated to 10.8%, including arrangement costs and the initial market value of the transferred warrants allocated during the term of the loan. In connection to the signing of the agreement , an issue of 2 829 231 warrants was performed, whereof 1 138 646 warrants representing 1.26% of outstanding shares after dilution has been transferred to EIB without compensation. The remaining warrants are held by the company and may be transferred to EIB in connection to a possible utilization of the remaining tranches related to the loan agreement. EIB has the right to exercise the warrants and subscribe for shares at the quota value. The warrants may be exercised at any time for a period of 20 years, in full or in part, by the warrant holder. EIB has the right, under certain circumstances and in connection to the repayment of the loan, to demand that Oncopeptides acquire the warrants at fair value in a situation when it is not possible to transfer the warrants to a third party. NOTE 7 - RELATED PARTY TRANSACTIONS Remuneration to senior management has been paid in accordance with current policies. No other transactions with related parties, outside of the Oncopeptides Group, occurred during the period. Notes to the consolidated and Parent Company financial statements 8ONCOPEPTIDES | INTERIM REPORT Q1 2025 ===== SIDA 9 ===== NOTE 8 - SHARE BASED INCENTIVE PROGRAMS The purpose of share-based incentive programs is to promote the company’s long-term interests by motivating and rewarding the company’s senior management, founders, and other co -workers in line with the interest of the shareholders. Oncopeptides has currently nine programs that include the management team, certain Board members, founders and employees. Program • 2017; ”Co- worker LTIP 2017” • 2018; ”Co- worker LTIP 2018” • 2019; ”Co- worker LTIP 2019” • 2021; ”Co- worker LTIP 2021” • 2022; ”Co- worker LTIP 2022” and ”Board SHP 2022” • 2023; ” Co-worker LTIP 2023” • 2024; ” Co-worker LTIP 2024” and ”Board SHP 2024 For more information on the programs see Note 26 in the Annual report 2024 as well as Agendas and Minutes from the relevant Annual General Meetings on the company's website www.oncopeptides.com. At the end of the period, full utilization (including warrants for securing social security contributions but excluding warrants related to EIB), of • Options and share awards resolved by the AGM and awarded to named individuals corresponding to 10,109,772 shares, would result in a dilution of 4.6 percent. • Options and share awards resolved by the AGM and awarded to named individuals as well as those not yet awarded to individuals, corresponding to 17,704,225 shares, would result in a dilution of 7.7 percent. NOTE 9 - SIGNIFICANT EVENTS AFTER THE PERIOD No significant events occurred after the end of the period other than as mentioned in the report. Notes 9ONCOPEPTIDES | INTERIM REPORT Q1 2025 ===== SIDA 10 ===== 10 Telephone conference Kontakt Key performance measures In this report, certain key performance measures are presented, including measures that are not defined under IFRS, • Research and development / operating expenses, %, • Gross margin, TSEK, %. The company believes that these measurements provides valuable additional information when evaluating the company’s economic trends. These financial performance measures should not be viewed in isolation, nor be considered in replacement of performance indicators that are prepared in accordance with IFRS. Further, such performance measures, as the company has defined them, should not be compared with other performance measures with similar names used by other companies since definitions and calculation methods may vary between companies. Rapport Datum Interim report Q2 2025 21 August 2025 Interim report Q3 2025 5 November 2025 Oncopeptides AB Visiting address; Luntmakargatan 46, 111 37 Stockholm Domicile: Luntmakargatan 46, 111 37 Stockholm, Sweden Telephone: +46 8 615 20 40 E-mail: info@oncopeptides.com Website: oncopeptides.com Financial Calendar Thesaurus Contact EMA European Medicines Agency Europeiska läkemedelsmyndigheten CHMP The European Medicines Agency‘s Committee for Medicinal Products for Human Use Europeiska läkemedelsmyndighetens kommitté för humanläkemedel ONCOPEPTIDES | INTERIM REPORT Q1 2025 The interim report for the period and an operational update will be presented by CEO Sofia Heigis and members of Oncopeptides Leadership team, Thursday May 15, 2025, at 09:00 (CET). If you wish to participate via webcast, please use the link below. Through the webcast you can ask written questions. https://oncopeptides.events.inderes.c om/q1-report-2025 If you wish to participate via telephone conference, please register on the link below. After registration you will be provided a phone numbers and a conference ID to access the conference. You can ask questions verbally via the telephone conference. https://conference.inderes.com/teleco nference/?id=5005188 This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CET on May 15, 2025. 1) Defined by subtracting cost of goods sold from total sales. The key figure shows gross profitability of cost of goods sold in absolute numbers. 2) Defined by dividing the sum of the company's gross profit by total sales. The key figure aims to clarify the relative profitability of goods sold. 3) For more information, please see the notice to the Annual General Meeting 2024. 4) Earnings per share before dilution are calculated by dividing earnings attributable to shareholders of the Parent Company by a weighted average number of outstanding shares during the period. There is no dilution effect driven by the employee stock option program, as earnings for the periods have been negative. 5) Defined by dividing the research and development costs with total operating expenses. The key performance measure provides an indication of the proportion of expenses that are attributable to the company’s core business.