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Multiple Myeloma ���������������������� P.12 Consolidated Statement Difference for Patients.” of Changes in Equity ����������������� P.56 Read More on Page 4 ANNUAL REPORT 2020 Bringing HOPE through Celebrating science 20 years This is Oncopeptides ���������������������p1 Remuneration Report p41 Marty J Duvall, CEO 2020 in brief ����������������������������������p2 Directors’ Report ����������������������� p43 “This past year has been a transformational one Letter from the CEO ������������������� p4 Corporate Governance for Oncopeptides highlighted by the FDA accep- Report ����������������������������������������� p48 Oncopeptides 20 Years p6 tance and priority review of our NDA submission Consolidated statement for melflufen, leading to the FDA approval in Corporate goals 2021 p8 of comprehensive income p54 the beginning of 2021 Not many emerging bio- Value creation model p9 Consolidated statement tech companies cross the finish line in terms of Equity story p10 of financial position p55 launching a product that can make a significant Multiple myeloma p12 Consolidated statement difference for patients.” of changes in equity p56 Read more on page 4. Patient story p14 Consolidated statement Cl Melflufen p16 of cash flows ����������������������������� p56 The multiple myeloma Parent Company Cl Cl market p18 income statement ����������������������p57 Launch ready in the US ������������� p20 N Parent Company statement Cl Peptide drug conjugate of comprehensive income p57 Melflufen N N Cl Cl platform ������������������������������������� p22 Parent Company Melfufen is our first in class anti-cancer Patents and intellectual balance sheet p58 O peptide drug conjugate, PDC, targeting H O O Content property p24 aminopeptidases and rapidly releases H H Parent Company statement N N N H N H N Regulatory roadmap p27 of changes in equity p59 alkylating agents into tumor cells 2 O H2N O 2 O Read more on page 15. HCl O Clinical development Parent Company HCl O HCl O program p28 statement of cash flow p59 Notes to the consolidated and Sustainability ����������������������������� p32 F F Parent Company financial The share p36 statements ��������������������������������� p60 F Glossary p38 Certification ������������������������������� p82 Auditor’s Report p83 Cl Cl Board of Directors ��������������������� p86 Management p88 A unique technology platform Celebrating Our proprietary PDC-platform gives us a N N Welcome to Cl Cl 20 years the 2021 AGM ����������������������������� p90 unique competitive advantage because it enables us to build a robust flexible drug O O of dedicated candidate pipeline H H N N research and clinical Read more on page 22. H N H2N O 2 O development HCl O HCl O F F 2020 in Brief In brief Oncopeptides brings hope to patients through passionate Oncopeptides is a global biotech company people, innovative science, and focused on the development of targeted transformative medicines� therapies for difficult-to-treat hematological diseases� The company uses its proprietary peptide-drug conjugate (PDC) platform to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Key figures (SEK thousand) 2020 2019 Net sales – – Operating loss -1,591,279 -739,392 Loss before tax -1,592,442 -739,920 Loss for the period -1,594,693 -740,705 Earnings per share before and after dilution (SEK) -25.57 -14.33 This is Cash flow from operating activities -1,296,509 -690,566 Cash and cash equivalents at the end of the period 840,255 926,186 Research & development costs/operating Oncopeptides expenses, % 54% 74% On February 26 2021, the U.S. Food and Drug Administration, FDA, approved PEPAXTO® (melphalan flufenamide) known as melflufen during clinical development, in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. ONCOPEPTIDES | ANNUAL REPORT 2020 1 (90) 2020 in Brief appointed General Manager of our US Business Unit� Prior to joining Oncopeptides, Mohamed 2020 – A year headed the commercial organi- zation in the US. During 2020, our US organization grew from just 16 to 136 employees� This includes of TRANSFORMATION a sales organization of around 50 people who have extensive com- 2020 was a transformational year for Oncopeptides. The major mile- mercial experience in hematology and oncology. The establishement of our drug development laboratory stones were the submission of melflufen for accelerated approval and will help the build-up of future drug pipeline. FDA's descision to do a priority review. We made significant progress in PAVING THE WAY FOR EARLIER our research and development programs, advanced our organizational LINES OF THERAPY We advanced our clinical devel- capabilities, strategic direction, and company culture. In 2020, we deliv- opment program significantly multiple myeloma – was well FDA accepted our IND applica- ered on all major milestones, despite exceptionally challenging condi- during 2020 by building the tolerated and had a similar tion to initiate clinical studies data sets needed to support safety profile as when used as a in OPD5. tions caused by the ongoing global pandemic� These milestones include: the potential use of melflufen doublet regimen� in earlier lines of therapy in FOUNDATIONS LAID FOR multiple myeloma. The first patient was enrolled in GEOGRAPHIC EXPANSION STRENGTHENED a priority review with a target proprietary PDC-platform and our phase 3 LIGHTHOUSE study We announced the decision to FINANCIAL POSITION date of February 28, 2021. broaden our scientific agenda Patient enrolment in the phase in multiple myeloma� The study submit an application for con- We completed a directed share beyond melflufen. 3 OCEAN study was completed will evaluate the efficacy and ditional marketing authoriza- issue of SEK 1,414M (USD 144M) STRENGTHENED COMMERCIAL with 495 patients. The study is a safety of the combination ther- tion of melflufen in the EU in Q2 to leading life science inves- AND SCIENTIFIC LEADERSHIP INDICATION BEYOND MYELOMA direct comparison with pomalid- apy with melflufen and subcuta- of 2021. tors in May and secured a EUR The day after the NDA sub- In the fall, we initiated the omide in patients with relapsed neous daratumumab, compared 40M loan agreement with the mission to the FDA, Marty J phase 1/2 ASCENT study in AL refractory multiple myeloma� to daratumumab alone� ADVANCED COMPANY CULTURE European Investment Bank in Q3� Duvall was appointed CEO amyloidosis, which is the first Top line results are expected in Our number of co-workers grew of Oncopeptides, and Jakob melflufen study outside multiple Q2 2021� NEW CLINICAL CANDIDATE from 88 to 280 in 2020� We also PRIORITY REVIEW GRANTED Lindberg assumed the role of myeloma� AL amyloidosis is a FROM PDC PLATFORM improved our organizational We submitted an NDA to the Chief Scientific Officer. Marty rare clonal plasma cell disease� We presented phase 2 ANCHOR During the third quarter, we capabilities and further devel- FDA for accelerated approval of brings extensive global com- There is currently a significant data at the American Society established a preclinical drug oped our strong company culture melflufen in combination with mercialization skills from senior unmet medical need� Patients of Hematology (ASH) annual development laboratory, with a new vision and core val- dexamethasone in adult patients executive roles in pharma and have poor prognosis and limited meeting. This data showed that a with leading researchers to ues that leverage our heritage with triple-class refractory biotech including unique expe- treatment alternatives� triplet regimen – with melflufen strengthen the proprietary PDC and support our continued multiple myeloma by the end of rience from the hematology and and dexamethasone in combi- platform and build future drug growth. We are a science-driven June. The submission was based oncology segments. Jakob will PREPARING FOR MARKET nation with daratumumab or pipeline. We progressed with company, passionate about mak- on data from the pivotal phase 2 lead the development of our R&D LAUNCH IN THE US bortezomib in heavily pretreated OPD5, the second drug to come ing a difference for patients. HORIZON study and was granted strategy to fully leverage the In Q3, Mohamed Ladha was patients with relapsed refractory out of our PDC platform, and the ONCOPEPTIDES | ANNUAL REPORT 2020 2 (90) 2020 in Brief Q2 Q3 April 1-June 30 July 1-September 30 Q1 • NDA for accelerated approval • Marty J Duvall appointed of melflufen submitted to FDA CEO, effective July 1; Jakob January 1-March 31 Lindberg became Chief • A preclinical drug devel- Scientific Officer • Top line results from pivotal opment laboratory was phase 2 HORIZON study pre- established to strengthen PDC • FDA granted priority review of sented, including 26% Overall technology platform and build Mohamed Ladha, General melflufen in patients with tri- Eva Nordström, COO Response Rate of melflufen in future pipelines Manager US and Marty J Duvall, CEO ple-class refractory multiple myeloma. Target review date triple-class refractory multi- • Directed share issue of SEK (PDUFA) was set for February ple myeloma patients 1,414M (USD 144M) to leading 28, 2021 • The Lancet Hematology pub- life science investors� • Patient enrolment in phase Q4 lished detailed results from • Enrolment in phase 3 OCEAN 3 OCEAN study completed;
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