Genmab(GMAB) - 2022 Q3 - Quarterly Report

Report Highlights Genmab reported strong financial growth in the first nine months of 2022, advanced epcoritamab regulatory submissions, and raised its full-year financial guidance Financial Performance First Nine Months of 2022 For the first nine months of 2022, Genmab reported a 60% increase in revenue to DKK 9,368 million and a 55% rise in operating expenses to DKK 5,676 million, resulting in an operating profit of DKK 3,692 million. The growth was primarily driven by higher royalty revenue from key products like DARZALEX, Kesimpta, and TEPEZZA, alongside a favorable USD/DKK exchange rate Financial Highlights for the First Nine Months of 2022 (vs. 2021) | Metric | Nine Months 2022 (DKK million) | Nine Months 2021 (DKK million) | Change | | :--- | :--- | :--- | :--- | | Revenue | 9,368 | 5,863 | +60% | | Royalty Revenue | 8,207 | 4,698 | +75% | | Operating Expenses | 5,676 | 3,654 | +55% | | Operating Profit | 3,692 | 2,209 | +67% | | Net Financial Income | 2,681 | 808 | +232% | - The increase in royalty revenue was driven by higher net sales of DARZALEX, Kesimpta®, and TEPEZZA®, as well as a higher average exchange rate between the USD and DKK[4] - Net sales of DARZALEX® by Janssen increased by 35% to USD 5,894 million in the first nine months of 2022 compared to the same period in 2021[4] Epcoritamab Regulatory Update Genmab and its partner AbbVie have made significant regulatory progress with epcoritamab. Genmab submitted a Biologics License Application (BLA) to the U.S. FDA, and AbbVie submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the treatment of certain types of large B-cell lymphoma - Genmab submitted a BLA to the U.S. FDA for subcutaneous (SC) epcoritamab for treating relapsed/refractory large B-cell lymphoma (LBCL)[5] - AbbVie submitted an MAA to the EMA for SC epcoritamab for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL), which has been validated by the EMA[5] 2022 Financial Guidance Update Genmab has raised its 2022 financial guidance, citing positive foreign exchange rate impacts on royalty revenue and the continued strong sales performance of DARZALEX Revised 2022 Financial Guidance (DKK million) | Metric | Revised Guidance | Previous Guidance | | :--- | :--- | :--- | | Revenue | 13,500 - 14,500 | 12,000 - 13,000 | | Operating Expenses | (8,000) - (8,400) | (7,600) - (8,200) | | Operating Profit | 5,100 - 6,500 | 3,800 - 5,400 | MANAGEMENT'S REVIEW This section provides a comprehensive overview of Genmab's consolidated financial performance, updated 2022 guidance, strategic priorities, pipeline advancements, and identified risks Consolidated Key Figures The company's consolidated financials for the first nine months of 2022 show significant year-over-year growth. Revenue increased to DKK 9,368 million from DKK 5,863 million, and net profit more than doubled to DKK 4,938 million from DKK 2,292 million. Total assets grew to DKK 30,686 million, with shareholders' equity reaching DKK 26,657 million Income Statement Highlights (Nine Months Ended Sep 30) | Metric (DKK million) | 2022 | 2021 | | :--- | :--- | :--- | | Revenue | 9,368 | 5,863 | | Operating Profit | 3,692 | 2,209 | | Net Profit | 4,938 | 2,292 | Balance Sheet Highlights (as of Sep 30) | Metric (DKK million) | 2022 | 2021 | | :--- | :--- | :--- | | Total Assets | 30,686 | 23,985 | | Shareholders' Equity | 26,657 | 21,285 | - Diluted net profit per share for the first nine months of 2022 was DKK 74.83, a significant increase from DKK 34.72 in the same period of 2021[11] - The average number of full-time employees (FTE) grew to 1,402 in the first nine months of 2022 from 967 in the prior year period[11] Outlook Genmab increased its full-year 2022 financial guidance, primarily due to favorable foreign exchange rates and strong DARZALEX sales. Revenue is now projected to be DKK 13,500-14,500 million, with operating profit expected between DKK 5,100-6,500 million. The guidance assumes a USD/DKK exchange rate of 7.2 and includes a potential milestone for the U.S. FDA's acceptance of the epcoritamab BLA submission Revised 2022 Guidance Details (DKK million) | Metric | Revised Guidance | Previous Guidance | | :--- | :--- | :--- | | Revenue | 13,500 - 14,500 | 12,000 - 13,000 | | Operating Expenses | (8,000) - (8,400) | (7,600) - (8,200) | | Operating Profit | 5,100 - 6,500 | 3,800 - 5,400 | - Projected 2022 revenue includes DARZALEX royalties of DKK 10,000 – 10,300 million, based on estimated net sales of USD 8.0 – 8.2 billion[13] - The increase in anticipated operating expenses to DKK 8,000 – 8,400 million is primarily driven by the negative impact of the strong U.S. Dollar[14] - The guidance is subject to risks including milestone achievements, development timelines, and currency exchange rates, with the assumed USD/DKK rate revised from 6.8 to 7.2[16] Key 2022 Priorities Genmab's key priorities for 2022 focus on advancing its late-stage clinical pipeline, particularly epcoritamab, and establishing Tivdak as a standard treatment for cervical cancer. The company also aims to grow its early-stage product candidates, scale its organization, and leverage its strong financial position to expand its antibody and technology portfolio - A top priority is the broad and rapid development of the late-stage clinical pipeline, highlighted by the planned submission of the first BLA for epcoritamab[19] - For Tivdak, the company aims to establish it as a clear choice for 2L+ recurrent/metastatic cervical cancer patients and broaden its clinical development into other solid tumors[19] - Genmab plans to expand and advance its proprietary clinical product portfolio and use its solid financial base to grow its antibody product and technology portfolio[19] Product Pipeline and Technology Progress Genmab's pipeline includes eight proprietary antibody products in clinical development, led by the FDA-approved Tivdak and the late-stage epcoritamab. The company's technology platforms have also powered five approved medicines and multiple investigational drugs developed by partners. Key progress in the third quarter includes regulatory submissions for epcoritamab and expanded collaborations with BioNTech - As of the end of Q3 2022, Genmab's proprietary pipeline (≥50% ownership) consists of eight antibody products in clinical development, including the approved medicine Tivdak[20] - In addition to its own pipeline, five approved medicines powered by Genmab's technology are being developed and marketed by global partners[20] Genmab Proprietary Investigational Medicines The proprietary pipeline is led by Tivdak, co-developed with Seagen for cervical cancer, and epcoritamab, co-developed with AbbVie for B-cell lymphomas, which has recently had regulatory submissions in the U.S. and EU. Other key assets developed with BioNTech, such as DuoBody-PD-L1x4-1BB and DuoBody-CD40x4-1BB, are advancing in clinical trials for solid tumors - Tivdak (tisotumab vedotin-tftv): The first and only U.S. FDA-approved antibody-drug conjugate (ADC) for recurrent or metastatic cervical cancer, co-developed and co-promoted with Seagen[25][26][28] - Epcoritamab (DuoBody-CD3xCD20): A bispecific antibody co-developed with AbbVie. In H2 2022, a BLA was submitted to the U.S. FDA for relapsed/refractory LBCL, and an MAA was submitted to the EMA for relapsed/refractory DLBCL[30][32][33] - DuoBody-PD-L1x4-1BB (GEN1046/BNT311): A bispecific antibody co-developed with BioNTech, currently in a Phase 2 study for non-small cell lung cancer (NSCLC)[31] Products Powered by Genmab's Technology and Innovations Genmab's technology has enabled several successful commercial products, generating significant royalty revenue. DARZALEX (Janssen) for multiple myeloma had net sales of USD 5,894 million in the first nine months of 2022. Other key royalty-generating products include Kesimpta (Novartis) for multiple sclerosis and TEPEZZA (Horizon) for thyroid eye disease. Additionally, RYBREVANT and TECVAYLI, both developed with Janssen using the DuoBody platform, have received regulatory approvals - DARZALEX (daratumumab): Developed by Janssen, net sales reached USD 5,894 million in the first nine months of 2022. Genmab receives double-digit royalties[49][52] - Kesimpta (ofatumumab): Marketed by Novartis for multiple sclerosis, it is the first B-cell therapy self-administered by patients at home. Genmab receives 10% royalties on net sales[51][53] - TEPEZZA (teprotumumab-trbw): Marketed by Horizon, it is the first FDA-approved medicine for Thyroid Eye Disease (TED). Genmab receives mid-single digit royalties[55][60] - TECVAYLI (teclistamab): The second approved medicine from the Genmab-Janssen DuoBody collaboration, receiving European approval in August 2022 for relapsed and refractory multiple myeloma[62][63][69] Significant Risks and Uncertainties The company reports no significant changes to its overall risk profile since its 2021 Annual Report. However, it highlights that the full impact of the COVID-19 pandemic on its business and financial performance remains uncertain and could materially affect clinical trials, regulatory timelines, and revenues - There have been no significant changes to Genmab's overall risk profile since the publication of the 2021 Annual Report and Form 20-F[73] - The COVID-19 pandemic continues to pose a risk, with its full extent and nature of impact on the business and financial performance remaining uncertain[73] Financial Review Genmab's revenue for the first nine months of 2022 grew 60% to DKK 9,368 million, driven by a 75% increase in royalties, particularly from DARZALEX. Operating expenses rose 55% to DKK 5,676 million due to pipeline advancement and organizational expansion. Net profit more than doubled to DKK 4,938 million, significantly boosted by a DKK 2,681 million net financial income, largely from favorable currency exchange rates. The company's financial position remains strong with DKK 23.8 billion in cash and marketable securities Revenue Total revenue for the first nine months of 2022 increased by 60% to DKK 9,368 million. This growth was dominated by a 75% rise in royalty revenue to DKK 8,207 million, primarily from increased sales of DARZALEX, Kesimpta, and TEPEZZA. Collaboration revenue of DKK 273 million was newly recognized, related to the Tivdak partnership with Seagen Revenue Breakdown (Nine Months Ended Sep 30, DKK million) | Revenue Type | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Royalties | 8,207 | 4,698 | +75% | | Reimbursement revenue | 594 | 371 | +60% | | Milestone revenue | 288 | 794 | -64% | | Collaboration revenue | 273 | — | N/A | | Total revenue | 9,368 | 5,863 | +60% | Royalty Revenue by Product (Nine Months Ended Sep 30, DKK million) | Product | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | DARZALEX | 7,073 | 4,167 | +70% | | TEPEZZA | 597 | 384 | +55% | | Kesimpta | 509 | 140 | +264% | | Total Royalties | 8,207 | 4,698 | +75% | Operating Expenses Operating expenses for the first nine months of 2022 increased by 55% to DKK 5,676 million. Research and development (R&D) expenses grew 36% to DKK 3,921 million, driven by the advancement of epcoritamab and other pipeline projects. Selling, general and administrative (SG&A) expenses saw a significant 128% increase to DKK 1,755 million, reflecting investments in commercial capabilities for Tivdak and future launches - R&D expenses increased by 36% to DKK 3,921 million, primarily due to the advancement of epcoritamab, DuoBody-CD40x4-1BB, and an increase in team members[92] - SG&A expenses increased by 128% to DKK 1,755 million, driven by team expansion to support the Tivdak launch and building out commercial and organizational infrastructure[96] Profitability and Financial Items Operating profit for the first nine months of 2022 was DKK 3,692 million, up from DKK 2,209 million in the prior year. Net profit surged to DKK 4,938 million from DKK 2,292 million. This was significantly influenced by net financial income of DKK 2,681 million, a substantial increase from DKK 808 million in 2021, primarily due to large foreign exchange gains from the strengthening of the USD against the DKK - Operating profit for the first nine months of 2022 was DKK 3,692 million, compared to DKK 2,209 million in the same period of 2021[99] - Net financial items were an income of DKK 2,681 million, a DKK 1,873 million increase from 2021, primarily driven by net foreign exchange rate gains as the USD strengthened against the DKK[4][100] - Net profit for the first nine months of 2022 was DKK 4,938 million, more than double the DKK 2,292 million from the same period in 2021[106] Liquidity and Capital Resources As of September 30, 2022, Genmab held DKK 13,411 million in marketable securities and DKK 10,377 million in cash and cash equivalents. Net cash from operating activities increased to DKK 3,514 million. Cash used in investing activities was DKK 2,625 million, while cash used in financing activities increased to DKK 920 million, mainly due to DKK 908 million in treasury share purchases Cash and Liquidity (DKK million) | Metric | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Marketable securities | 13,411 | 10,381 | | Cash and cash equivalents | 10,377 | 8,957 | | Shareholders' equity | 26,657 | 22,196 | Cash Flow Summary (Nine Months Ended Sep 30, DKK million) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Operating activities | 3,514 | 1,987 | | Investing activities | (2,625) | (655) | | Financing activities | (920) | (436) | Legal Matters – Janssen Binding Arbitrations Genmab has initiated a second binding arbitration with Janssen concerning the daratumumab license agreement. Following a prior ruling that DARZALEX FASPRO (subcutaneous formulation) is a new product, Genmab is now seeking USD 405 million in accrued milestone payments and a declaration for a new 13-year royalty term from its first commercial sale - A prior arbitration tribunal ruled that DARZALEX FASPRO constitutes a new licensed product under the license agreement with Janssen[122] - Genmab has commenced a second arbitration seeking an award of USD 405 million plus interest in accrued milestone payments for DARZALEX FASPRO[123] - The company is also seeking a declaration that it is entitled to a new 13-year royalty term from the date of DARZALEX FASPRO's first commercial sale[123] Financial Statements This section presents the unaudited consolidated financial statements for the Genmab group for the nine months ended September 30, 2022. It includes the Statements of Comprehensive Income, Balance Sheets, Statements of Cash Flows, and Statements of Changes in Equity, providing a detailed view of the company's financial performance and position Key Financial Statement Figures (Nine Months Ended Sep 30, 2022) | Metric (DKK million) | Value | | :--- | :--- | | Net Profit | 4,938 | | Total Assets | 30,686 | | Total Shareholders' Equity | 26,657 | | Net Cash from Operating Activities | 3,514 | Notes to the Financial Statements The notes provide detailed explanations of the accounting policies and specific items within the financial statements. Key notes cover the breakdown of revenue by partner and product, the composition and valuation of financial instruments, details on financial income and expenses, share-based compensation programs, related party transactions, and lease obligations Note 2 – Revenue This note details the composition of Genmab's revenue. For the first nine months of 2022, Janssen was the largest contributor, accounting for DKK 7,378 million of the total DKK 9,368 million in revenue. Royalties from DARZALEX alone amounted to DKK 7,073 million Revenue by Collaboration Partner (Nine Months Ended Sep 30, DKK million) | Partner | 2022 | 2021 | | :--- | :--- | :--- | | Janssen | 7,378 | 4,722 | | Roche | 597 | 384 | | Novartis | 539 | 141 | | BioNTech | 511 | 284 | | Seagen | 330 | 87 | | Total | 9,368 | 5,863 | Note 5 – Share-Based Instruments Genmab utilizes Restricted Stock Unit (RSU) and warrant programs for employee incentives. In the first nine months of 2022, the company granted 260,523 RSUs and 249,901 warrants. Share-based compensation expense totaled DKK 326 million. Additionally, Genmab repurchased 370,000 of its own shares for DKK 908 million to cover obligations from these programs - Share-based compensation expense for the first nine months of 2022 was DKK 326 million, up from DKK 228 million in the same period of 2021[152] - During the first nine months of 2022, Genmab acquired 370,000 of its own shares for a total cost of DKK 908 million under its share buy-back program[154] About Genmab Genmab is an international biotechnology company focused on improving the lives of people with cancer. With over 20 years of experience, the company invents next-generation antibody technology platforms and leverages research and data sciences to create differentiated cancer treatments. Genmab has over 20 strategic partnerships and a proprietary pipeline that includes bispecific T-cell engagers, immune checkpoint modulators, and antibody-drug conjugates - Genmab's core purpose is to improve the lives of people with cancer through the invention of next-generation antibody technologies[168] - The company has formed over 20 strategic partnerships with biotechnology and pharmaceutical companies to develop and deliver novel therapies[168] Directors' and Management's Statement on the Interim Report The Board of Directors and Executive Management have adopted the unaudited interim report for the nine months ended September 30, 2022. They state that the report is prepared in accordance with IAS 34 and gives a true and fair view of the group's financial position, results, and cash flows. They also affirm that the Management's Review provides a fair account of the group's development and significant risks - The interim report is prepared in accordance with IAS 34, "Interim Financial Reporting," and additional Danish disclosure requirements[174] - Management considers the accounting policies appropriate and believes the report gives a true and fair view of the group's financial position and performance[174]