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Oncopeptides

Quarterly Report May 4, 2022

3091_10-q_2022-05-04_e5c41cc8-3806-4a40-a479-5eaa0b09d5ce.pdf

Quarterly Report

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S ignificant events

JANUARY-MARCH

  • EMA review process of melflufen in Europe is proceeding as expected and includes both the HORIZON and OCEAN data sets
  • A recission of the withdrawal of Pepaxto in the US was announced on January 21
  • Phase 3 OCEAN study was published in the Lancet Haematology on January 13 and data has been shared with regulatory authorities

EVENTS AFTER THE PERIOD

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-MARCHNet 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

Science leads the way

Continued confidence in our science and data

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.

OCEAN DATA PUBLISHED IN THE LANCET HAEMATOLOGY

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).

RESCISSION OF VOLUNTARY WITHDRAWAL OF PEPAXTO

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.

UPDATE ON REGULATORY REVIEW PROCESS IN EUROPE

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.

EARLY ACCESS PROGRAM IN EUROPE CONFIRMS UNMET MEDICAL NEED

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.

INCREASED FOCUS ON RESEARCH AND DEVELOPMENT

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

REVENUE

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

OPERATING EXPENSES

SEK 0.0 M (19.0).

Operating expenses, excluding cost of goods sold, for the quarter amounted to SEK 98.9 M (366.4).

RESEARCH AND DEVELOPMENT EXPENSES

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 EXPENSES

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

General and administrative expenses amounted to SEK 23.2 M (47.6).

EXPENSES FOR SHARE BASED INCENTIVE PROGRAMS

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.

EFFECTS OF COVID -19

The effects of Covid -19 are not deemed to have any material effects on the financial statements.

THE WAR IN UKRAINE

The situation in the Ukraine is not deemed to have any material effects on the financial statements.

TAX AND EARNINGS

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, INVESTMENTS AND FINANCIAL POSITION

Cash flow from operating activities amounted to SEK -166.0 M ( -386.7). Cash flow from

  • Investment activities amounted to SEK 0.0 M ( - 0.7)
  • Financing activities amounted to -4.0 (3.5) MSEK.

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.

FINANCING AND GOING CONCERN

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,

  • Access to/delay of payment from the EIB loan facility, currently under renegotiation
  • Delayed commercial sales
  • Loss of key employees

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.

EMPLOYEES

At the close of the period, the Company had 76 (294) co -workers.

PARENT COMPANY

Parent company operations are aligned with those of the Group, why the comments for the Group are also relevant for the Parent company.

ONCOPEPTIDES SHARE

The number of registered shares and votes at the end of the period amounted to 75,307,217.

EVENTS AFTER THE PERIOD

No significant events have occurred after the reporting period.

AUDIT

This report has not been reviewed by the company's auditor.

3

Stockholm, May 4, 2022

Jakob Lindberg

CEO

Condensed consolidated statement of comprehensive income Condensed consolidated statement of financial position

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.

Condensed consolidated statement of changes in equity Condensed consolidated statement of cash flow

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.

Condensed Parent Company income statement

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.

Condensed Parent Company statement of comprehensive income

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

Parent Company balance sheet

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

NOTE 1 - GENERAL INFORMATION

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.

NOTE 2 - ACCOUNTING PRINCIPLES

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.

NOTE 3 - RISKS AND UNCERTAINTIES

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.

NOTE 4 - ESTIMATES AND CONSIDERATIONS

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.

NOTE 5 - REVENUE RECOGNITION

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.

NOTE 6 - SEGMENT REPORTING

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.

NOTE 7 - RELATED PARTY TRANSACTIONS

Remuneration to senior management has been paid in accordance with current policies. No other transactions with related parties occurred during the period.

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 eight active programs that include the management team, certain board members, founders and employees.

Program

  • 2016; "Employee option program 2016/2023".
  • 2017; "Co-worker LTIP 2017"
  • 2018; "Co-worker LTIP 2018"
  • 2019; "Co-worker LTIP 2019" and "Board LTIP 2019"
  • 2020; "Board LTIP 2020"
  • 2021; "Board LTIP 2021" and "Co-worker LTIP 2021"

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.

NOTE 9 - SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

No significant events have occurred after the end of the period.

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, MSEK, %. 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.

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.

Telephone conference

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.

Report Datum AGM 2022 28 June, 2022 Interim report Q2, 2022 11 August, 2022 Interim report Q3, 2022 9 November, 2022 Year End report, 2022 16 February, 2023

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

Oncopeptides AB

Financial Calendar

Visiting adress; Luntmakargatan 46, 111 37 Stockholm Domecile: Västra Trädgårdsgatan 15, 111 53 Stockholm, Sweden

Telephone:

+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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