Quarterly Report • May 4, 2022
Quarterly Report
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Selected Key Indicators
No significant events have occurred after the reporting period.
| (TSEK) | 2022 Jan-Mar |
2021 Jan-Mar |
2021 Jan-Dec |
|---|---|---|---|
| Net sales | - | 19 355 | 118 295 |
| Operating profit | -98 865 | -347 331 | -1 420 917 |
| Profit after tax |
-98 587 | -234 664 | -1 430 317 |
| Earnings per share before and after dilution (SEK) | -1.31 | -3.45 | -19.00 |
| Cash flow from operating activities |
-166 033 | -386 714 | -1 516 391 |
| Cash at the end of the period | 194 315 | 372 453 | 362 187 |
| R & D costs/operating expenses, % | 67% | 49% | 46% |
Financial overview
amounted to SEK 0.0 M (19.4)
amounted to SEK -98.6 M (-234.7) • Profit per share, before and after dilution, amounted to SEK -1.31 (-3.45) • Cash balances at the end of the period amounted to SEK 194.3 M (372.5)
was SEK -98.9 M (-347.3)
JANUARI-MARCH • Net sales
• Operating profit
• Net profit
Pepaxto® (Melphalan flufenamide) is the US trade name. It is known as melflufen during clinical development.
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.
INTERIM REPORT - Q1, 2022
It´s with growing enthusiasm and confidence in our science and data that Oncopeptides moves into 2022. During the first quarter we shared comprehensive data with regulatory agencies in the US and Europe. How these data will be interpreted by regulators and scientific communities in the coming months will influence on how the OCEAN study will be elucidated, what role melflufen may have in the treatment of relapsed refractory multiple myeloma (RRMM), and the future direction of the Company.
On January 13, data from the randomized head-to-head phase 3 OCEAN study, evaluating the efficacy and safety of melflufen plus dexamethasone versus pomalidomide plus dexamethasone in lenalidomide refractory RRMM patients who have received 2-4 prior lines of therapy, was published in the Lancet Haematology. Melflufen met the primary endpoint of superior Progression Free Survival (PFS) in the ITT population, with a median PFS of 6.8 months, compared to 4.9 months for pomalidomide with a Hazard Ratio of 0.79 (p-value 0.03).
On January 21 Oncopeptides communicated that the Company has rescinded the October 22nd, 2021, letter to the US Food and Drug Administration (FDA), requesting voluntary withdrawal of Pepaxto. Further review and analyses of the heterogenous Overall Survival (OS) data from the OCEAN study and other
relevant trials led us to reconsider the voluntary withdrawal request. However, we will not re-introduce or market the drug in the US before the new data has been discussed and assessed with the FDA.
The dialogue with the FDA is aiming to reach a mutual understanding of the OCEAN data, and an agreement on the regulatory path forward. The dialogue with the FDA is a priority, however the agency has no formal process for this type of interaction, so we cannot anticipate how long it will take.
The recently published results from the phase 3 OCEAN study, and the analyses of the heterogenous OS data from OCEAN and other relevant trials provide valuable insights to the pending European Medicines Agency´s (EMA´s) review of melflufen. The agency review, which originally was based on the pivotal phase 2 HORIZON-study, now include
OCEAN as a potential confirmatory study. The EMA review process is proceeding as anticipated, and as part of this, EMA will hold a scientific advisory group meeting. We expect a CHMP opinion in Q2 followed by a potential approval by the European Commission in Q3.
In parallel with the EMA submission in 2021, an Early Access program was launched in Europe, to provide RRMM patients who cannot be adequately treated with approved and commercially available medications or drugs provided through clinical trials, access to melflufen. Currently approximately 70 patients are treated, and we receive continuous requests from treating haematologists, which clearly demonstrate the unmet medical need in multiple myeloma.
During the last quarter 2021, Oncopeptides decided go back to becoming a Sweden based R&D Company, dedicated to developing the proprietary PDC platform, including the next generation drug candidates OPD5 and OPDC3.
The outcome of the interactions with regulatory authorities will have a significant implication on the future direction of the Company, and how we can leverage the available assets in our early development pipeline.
I would like to take the opportunity to thank all employees for your dedicated contributions during this quarter, and all our shareholders for your continued belief in Oncopeptides.
Stockholm, May 4, 2022
Jakob Lindberg CEO

Jakob Lindberg, CEO
Net sales for the first quarter amounted to SEK -0.0 M (19.4). As the company does not have any commercial product, no sales has been recorded in 2022. Cost of goods sold for the first quarter amounted to SEK 0.0 M ( -0.3). Gross profit for the quarter amounted to
SEK 0.0 M (19.0).
Operating expenses, excluding cost of goods sold, for the quarter amounted to SEK 98.9 M (366.4).
Expenses relating to research and development amounted to SEK 65.8 M (178.5). Provisions relating to the already communicated close of studies, amounted to SEK 24.5 M at the end of the period.
Marketing and sales related expenses amounted to SEK 10.0 M (178.2). The expenses relate, primarily, to the ongoing EMA -filing application process.
General and administrative expenses amounted to SEK 23.2 M (47.6).
Expenses relating to provisions for social security costs vary with changes in the underlying share price. Such provisions are reported under long - and short -term liabilities.
The costs for share based related incentive programs amounted to SEK 7.4 M (5.5); of which provisions and payments for social security related expenses amounted to SEK 0.3 M ( -14.4), and expenses relating
to share -based remuneration amounted to SEK 7.1 M (19.9). The expenses have no cash impact. See note 8.
The effects of Covid -19 are not deemed to have any material effects on the financial statements.
The situation in the Ukraine is not deemed to have any material effects on the financial statements.
Earnings before taxes amounted to SEK -98.6 M (-347.9).
Net profit amounted to SEK -98.6 M ( -234.7); corresponding to a loss per share, before and after dilution, of SEK -1.31 ( -3.45).
Cash flow from operating activities amounted to SEK -166.0 M ( -386.7). Cash flow from
Cash -flow for the first quarter amounted to SEK -170.0 M ( -383.9).
Cash balances as per the end of the period amounted to SEK 194.3 M (372.5).
The Company has an unutilized loan facility of EUR 40 M with EIB. The terms enabling draw down of the facility are under renegotiation.
Equity amounted to SEK 119.1 M (347.2) at the end of the period.
The swift and decisive reduction of operational costs, initiated during the last quarter of previous year will improve the Group cash flow in line with previously published assumptions. The outcome of the interaction with regulatory authorities, will influence on the Company ´s financial position. The European marketing authorization process is currently progressing as expected. Should, however, the review not result in a marketing authorization, or if such a decision is delayed, a number of parameters and risk factors could be affected, including, but not limited to,
Following a marketing authorization, the Board of Directors and CEO assume that the Group will have the funds required to continue operations for at least the coming twelve months, provided that an agreement is reached with the EIB. Should an agreement with the EIB not be reached, for reasons that currently not can be foreseen, the Company may require additional cash contributions.
Should marketing authorization not be granted, the Company will rapidly focus operations on its early development portfolio, further advance the proprietary PDC platform, and the next generation drug candidates. The Board of Directors and the CEO assume that the Group will have the necessary funds to continue operations during at least the coming twelve months, in this scenario as well.
Should the above conditions not be fulfilled, the Group's continued operations are at risk. In aggregate, the above indicates that there are considerations that could raise to significant doubt as to the Company's continued ability to continue operations. For additional risks, please see Oncopeptides Annual Report 2021.
At the close of the period, the Company had 76 (294) co -workers.
Parent company operations are aligned with those of the Group, why the comments for the Group are also relevant for the Parent company.
The number of registered shares and votes at the end of the period amounted to 75,307,217.
No significant events have occurred after the reporting period.
This report has not been reviewed by the company's auditor.
3
Stockholm, May 4, 2022
CEO
| 2022 | 2021 | 2021 | ||
|---|---|---|---|---|
| SEK thousand | Note | Jan-Mar | Jan-Mar | Jan-Dec |
| Net sales | 5 | - | 19 355 | 118 2951) |
| Cost of Goods Sold | - | -328 | -53 121 | |
| Gross profit | - | 19 027 | 65 174 | |
| Research and development expenses | -65 828 | -178 532 | -679 926 | |
| Marketing and distribution expenses | -10 048 | -178 198 | -698 346 | |
| Administrative expenses | -23 206 | -47 630 | -175 459 | |
| Other operating income/expenses2) | 217 | 38 002 | 67 640 | |
| Total operating expenses | -98 865 | -366 358 | -1 486 091 | |
| EBIT; Operating profit/loss | -98 865 | -347 331 | -1 420 917 | |
| Net financial items | 266 | -521 | -455 | |
| EBT; Earnings before taxes | -98 599 | -347 852 | -1 421 372 | |
| Income tax | 12 | 113 188 | -8 946 | |
| Net profit | -98 587 | -234 664 | -1 430 317 | |
| Other comprehensive income | ||||
| Items to be reclassified as profit or loss | ||||
| Translation variances | -294 | -21 886 | 624 | |
| Other comprehensive income after tax | -294 | -21 886 | 624 | |
| Total comprehensive income3) | -98 881 | -256 550 | -1 429 693 | |
| Earnings per share before and after dilution (SEK) | -1.31 | -3.45 | -19.00 |
1) Including provisions for expected returns of SEK -48.6 M.
2) Exchange rate differences on assets and liabilities in operational activities.
2) Losses for the period are in total attributable to parent company shareholders.
| SEK thousand Note |
Mar 31, 2022 | Mar 31, 2021 | Dec 31, 2021 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | 29 862 | 168 855 | 27 003 |
| Total non-current assets | 29 862 | 168 855 | 27 003 |
| Current assets | |||
| Inventory | - | 11 629 | - |
| Current receivables | 36 890 | 148 928 | 50 186 |
| Cash | 194 315 | 372 453 | 362 187 |
| Total current assets | 231 205 | 533 010 | 412 373 |
| TOTAL ASSETS | 261 067 | 701 865 | 439 376 |
| EQUITY AND LIABILITIES | |||
| Equity | 119 128 | 347 192 | 210 868 |
| Total Equity1) | 119 128 | 347 192 | 210 868 |
| Long-term liabilities | 6 353 | 10 436 | 3 219 |
| Total long-term liabilities | 6 353 | 10 436 | 3 219 |
| Current liabilities | |||
| Trad payables | 14 279 | 86 742 | 35 702 |
| Other current liabilities | 121 307 | 257 495 | 189 587 |
| Total current liabilities | 135 586 | 344 237 | 225 289 |
| TOTAL EQUITY AND LIABILITIES | 261 067 | 701 865 | 439 376 |
1) Equity is in total attributable to parent company shareholders.

| 2022 | 2021 | 2021 | |
|---|---|---|---|
| SEK thousand Note |
Jan-Mar | Jan-Mar | Jan-Dec |
| Opening Balance | 210 868 | 576 897 | 576 897 |
| Net profit | -98 587 | -234 664 | -1 430 317 |
| Other comprehensive income | -294 | -21 886 | 624 |
| Total comprehensive income | -98 881 | -256 550 | -1 429 693 |
| Transactions with owners | |||
| New directed share issue | - | - | 1 106 000 |
| Costs related to new directed share issue | - | - | -67 053 |
| Share based compensation | 7 106 | 19 874 | 14 229 |
| Exercised warrants | 34 | 6 972 | 10 488 |
| Total transactions with owners | 7 141 | 26 845 | 1 063 664 |
| Ending balance | 119 128 | 347 192 | 210 868 |
| 2022 | 2021 | 2021 | |
|---|---|---|---|
| SEK thousand Note |
Jan-Mar | Jan-Mar | Jan-Dec |
| Operating activities | |||
| Operating profit/loss | -98 865 | -347 331 | -1 420 917 |
| Adjustment for non-cash items1) | 8 566 | 41 012 | -44 325 |
| Interest received | - | - | 96 |
| Interest paid | -259 | -310 | -948 |
| Taxes paid | 6 | - | -12 216 |
| Cash-flow from operating activities before change in | |||
| working capital | -90 552 | -306 629 | -1 478 309 |
| Change in working capital | -75 481 | -80 085 | -38 082 |
| Cash-flow from operating activities | -166 033 | -386 714 | -1 516 391 |
| Cash-flow from investment activities | - | -740 | -339 |
| Cash-flow from financing activities | -3 959 | 3 507 | 1 034 030 |
| Cash-flow for the period | -169 992 | -383 947 | -482 701 |
| Cash at the beginning of the period | 362 187 | 840 255 | 840 255 |
| Change in cash | -169 992 | -383 947 | -482 701 |
| Effect of exchange rate changes on cash | 2 120 | -83 855 | 4 633 |
| Cash at the end of the period | 194 315 | 372 453 | 362 187 |
1) Pertains mainly to changes in share-based remuneration programs including social security contributions and exchange rate differences as well as depreciation and impairment.
| 2022 | 2021 | 2021 | |
|---|---|---|---|
| Note SEK thousand |
Jan-Mar | Jan-Mar | Jan-Dec |
| Net sales1) | - | 478 109 | 97 577 |
| Cost of Goods Sold | - | -2 251 | -12 182 |
| Gross profit | - | 475 858 | 85 395 |
| Research and development expenses | -65 930 | -178 384 | -676 375 |
| Marketing and distribution expenses | -15 339 | -182 592 | -728 382 |
| Administrative expenses | -20 392 | -47 862 | -161 814 |
| Other operating income/expenses2) | -549 | 38 112 | 71 362 |
| Total operating expenses | -102 210 | -370 726 | -1 495 209 |
| EBIT; Operating profit/loss | -102 210 | 105 132 | -1 409 814 |
| Net financial items3) | 4 729 | -185 | -18 725 |
| EBT; Earnings before taxes | -97 481 | 104 947 | -1 428 539 |
| Tax | - | - | - |
| EBT; Earnings before taxes | -97 481 | 104 947 | -1 428 539 |
1) Pertains to intra group revenues including credit of unsold packages during Q4-2021.
2) Exchange rate differences on assets and liabilities in operational activities. 3) Pertains primarily to subsidiary holdings.
| 2022 | 2021 | 2021 | ||
|---|---|---|---|---|
| TSEK | Note | Jan-Mar | Jan-Mar | Jan-Dec |
| EBT; Earnings before taxes | -97 481 | 104 947 | -1 428 539 | |
| Other comprehensive income | ||||
| - | - | - | - | |
| Other comprehensive income after tax | - | - | - | |
| Net profits | -97 481 | 104 947 | -1 428 539 |
| SEK thousand Note |
Mar 31, 2022 | Mar 31, 2021 | Dec 31, 2021 |
|---|---|---|---|
| ASSETS | |||
| Subscribed, not yet paid in captial | 1 106 000 | - | |
| Non-current assets | 11 940 | 28 286 | 12 910 |
| Total non-current assets | 11 940 | 28 286 | 12 910 |
| Current assets | |||
| Inventory | - | 10 684 | - |
| Current receivables | 27 043 | 514 061 | 28 752 |
| Cash | 150 619 | 332 889 | 321 832 |
| Total current assets | 177 662 | 857 634 | 350 584 |
| TOTAL ASSETS | 189 602 | 1 991 920 | 363 495 |
| EQUITY AND LIABILITIES | |||
| Restricted equity | 18 609 | 18 552 | 18 575 |
| Non-restricted capital | 95 704 | 1 721 716 | 186 078 |
| Total Equity | 114 313 | 1 740 268 | 204 653 |
| Long-term liabilities | 143 | 6 432 | 13 |
| Total long-term liabilities | 143 | 6 432 | 13 |
| Current liabilities | |||
| Trade payables | 10 467 | 58 283 | 34 875 |
| Other current liabilities | 64 679 | 186 937 | 123 954 |
| Total current liabilities | 75 146 | 245 220 | 158 829 |
| TOTAL EQUITY AND LIABILITIES | 189 602 | 1 991 920 | 363 495 |
This interim report covers the Swedish parent company Oncopeptides AB (publ), Swedish corporate identity no. 556596-6438 and its subsidiary Oncopeptides Incentive AB, Oncopeptides GmbH, Germany and Oncopeptides Inc, USA. The parent company is a Swedish public limited company registered in and with its registered office in Stockholm. Numbers in parentheses in the report refer to the figures for the corresponding period the previous year. The interim report for the first quarter 2022 was approved for publication on May 4, 2022.
The interim report for the Group has been prepared in accordance with IAS 34 Interim Financial Reporting. The parent company applies the Swedish Financial Reporting Board recommendation RFR2 Accounting for legal entities. Oncopeptides applies, except as described below, the same accounting principles as in the last Annual Report. Relevant accounting and valuation principles could be found on pages 60-63 of the Annual Report for 2021.
No new or amended standards that became effective January 1, 2022, have had a significant impact on the company's financial reporting.
Oncopeptides applies ESMA's (European Securities and Markets Authority) guidelines on alternative performance measures.
Oncopeptides is exposed to numerous amount of risk in its day to day operation. The management of these risk is in line with the business strategy and with the long-term interest of the company in mind, including sustainability. The Company has identified a number of important risk areas: Regulatory, operational, financial, and credit risks. For more information on risks, see Oncopeptides Annual report 2021.
This report includes forward looking statements. Actual outcomes may deviate from what has been stated. Internal factors such as successful management of research projects, and intellectual property rights may affect future financial outcomes. There are also external conditions, e.g., the economic climate, political changes and competing research projects that may affect Oncopeptides net profit. For more information see the Oncopeptides Annual report 2021.
Revenue is reported at the transaction value of goods sold excluding VAT, discounts and returns. At the time of delivery, when the ownership of the goods passes to the customer, the revenue is reported in full. Customers are defined as the retailers, who act as middlemen and in turn sell the goods to the end user.
As the final price is related to the discount granted the patients' insurance company, the transaction price is not known upon delivery. An estimated discount deduction provision, based on models considering statistical sales data and relevant discount programs, is therefore made. In addition, the Company makes, a provision for additional expected return related to the withdrawal of Pepaxto from the US market. It is stated in the consolidated balance sheet under Other current liabilities and amounted to SEK 28.2 million at the end of the quarter. The Company has no further performance obligations.
| Group Revenue | 2022 | 2021 | 2021 |
|---|---|---|---|
| SEK thousand | Jan-Mar | Jan-Mar | Jan-Dec |
| Net sales; customer contracts | |||
| Goods1) | - | 19 355 118 295 | |
| Total net revenue | - | 19 355 118 295 | |
| Geographic market | |||
| North America2) | - | 19 355 118 295 |
1) PEPAXTO (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, is used for the treatment of adult patients with relapsed or refractory multiple myeloma.
2) Approval was only obtained in the United States, which explains why all revenue refers to one market.
| Parent Company Revenue | 2022 | 2021 | 2021 |
|---|---|---|---|
| SEK thousand | Jan-Mar | Jan-Mar | Jan-Dec |
| Net sales; customer contracts | |||
| Goods | - | 478 1091) | 97 577 |
| Total net revenue | - | 478 109 | 97 577 |
| Geographic market | |||
| North America2) | - | 478 109 | 97 577 |
1) Refers to reversed intra-group sales of inventories.
2) Refers to intra-group sales to the subsidiary in the USA.
The financial information reported to the chief operating decision maker and used as a basis for the distribution of resources and the assessment of the Group's results, is not split across operating segment. Hence, the Group is reported as one single operating segment.
Remuneration to senior management has been paid in accordance with current policies. No other transactions with related parties occurred during the period.
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 eight active programs that include the management team, certain board members, founders and employees.
For more information on the programs see Note 27 in the Annual report 2021 and Agendas and Minutes from the relevant Annual General Meetings on the company's website www.oncopeptides.com.
Full utilization of granted options and share awards at the end of the period, corresponding to 3,927,911 shares, would result in a dilution for shareholders of 4.9 percent. Full utilization of all options and share awards, corresponding to 4,271,102 shares (i.e., including non-granted employee options and warrants set off as hedge for social security contributions), would result in a dilution of 5.3 percent.
No significant events have occurred after the end of the period.
In this report, certain key performance measures are presented, including measures that are not defined under IFRS,
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.
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.
Further, such performance
| 2022 | 2021 | 2021 | ||
|---|---|---|---|---|
| SEK thousand | Jan-Mar | Jan-Mar | Jan-Dec | |
| Net sales | - | 19 355 | 118 295 | |
| Gross profit1) | - | 19 027 | 65 174 | |
| Gross margin2) | - | 98% | 55% | |
| Total registered shares at the end of the period | 75 291 841 | 67 939 715 67 939 715 | ||
| No of registered shares at the beginning of the period | 75 307 217 | 68 084 855 75 291 841 | ||
| No of shares that the outstanding employee options entitle to | 3 927 911 | 3 876 863 2 254 457 | ||
| Share capital at the end of period | 8 367 | 7 549 | 8 366 | |
| Equity at the end of period | 119 128 | 347 192 | 210 868 | |
| Earnings per share before and after dilution, SEK3) | -1,31 | -3,45 | -19,00 | |
| Operating loss | -98 865 | -347 331 | -1 420 917 | |
| Research and development expenses | -65 828 | -178 532 | -679 926 | |
| Research and development expenses/operating expenses, %4) | 67% | 49% | 46% |
1) Defined by subtracting cost of goods sold from total sales. The key figure shows the 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) 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.
4) 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.
The Interim report for the first quarter 2022 and an operational update will be presented by CEO Jakob Lindberg and members of Oncopeptides Leadership team, Thursday May 4, 2022, at 11:00 (CET).
The conference call will be streamed via a link on the website: www.oncopeptides.com.
Participant phone numbers:
Sweden: +46 8 505 583 51
Europe: +44 333 300 92 62
USA: +1 631 913 14 22, PIN (USA only): 76766319#

Contact
Financial Calendar
Visiting adress; Luntmakargatan 46, 111 37 Stockholm Domecile: Västra Trädgårdsgatan 15, 111 53 Stockholm, Sweden
+46 8 615 20 40 E-mail: [email protected]
Website: oncopeptides.com

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 4, 2022.
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