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Genmab Announces Financial Results for the First Quarter of 2022

Key Takeaway: Genmab Announces Financial Results for the First Quarter of 2022 May 11, 2022 Copenhagen, Denmark; Interim Report for the First Quarter Ended March 31, 2022 "During the first quarter of 2022, there were continued advancements in our pipeline, including the first patient dosed

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Genmab Announces Financial Results for the First Quarter of 2022
May 11, 2022 Copenhagen, Denmark;
Interim Report for the First Quarter Ended March 31, 2022
"During the first quarter of 2022, there were continued advancements in our pipeline, including the first patient dosed with DuoBody -CD3xB7H4 (GEN1047), the presentation of data from the tisotumab vedotin innovaTV 207 study, and the U.S. Food and Drug Administration (U.S. FDA) granting orphan-drug designation to epcoritamab for the treatment of follicular lymphoma (FL). Together these events help to progress us further in our evolution into a fully integrated biotech innovation powerhouse," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter of 2022
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 1/34
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Genmab Announces Financial Results for the First Quarter of 2022
Genmab is updating the lower end of its 2022 financial guidance published on February 16, 2022, driven by increased royalty revenue related to net sales of DARZALEX.
Revised Previous
(DKK million) Guidance Guidance
Revenue 11,000 - 12,000 10,800 - 12,000
Operating expenses (7,200) - (7,800) (7,200) - (7,800)
Operating profit 3,200 - 4,800 3,000 - 4,800
Genmab will hold a conference call in English to discuss the results for the first quarter of 2022 today, Wednesday, May 11, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 913 1422 (U.S. participants) or +44 3333000804 (international participants) and provide conference code 48414786. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.
Marisol Peron, Senior Vice President, Communications and Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 2/34
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Quarter of 2022
MANAGEMENT'S REVIEW
CONSOLIDATED KEY FIGURES 4
OUTLOOK 5
KEY 2022 PRIORITIES 6
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST QUARTER OF 2022 6
SIGNIFICANT RISKS AND UNCERTAINTIES 14
FINANCIAL REVIEW 15
FINANCIAL STATEMENTS
STATEMENTS OF COMPREHENSIVE INCOME FOR THE FIRST QUARTER OF 2022 21
BALANCE SHEETS AS OF MARCH 31, 2022 22
STATEMENTS OF CASH FLOWS FOR THE FIRST QUARTER OF 2022 23
STATEMENTS OF CHANGES IN EQUITY FOR THE FIRST QUARTER OF 2022 24
NOTES TO THE FINANCIAL STATEMENTS 25
ABOUT GENMAB 33
DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT 34
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 3/34
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Quarter of 2022
CONSOLIDATED KEY FIGURES
3 Months Ended 3 Months Ended Full Year
March 31, 2022 March 31, 2021 2021
(DKK million)
Income Statement
Revenue 2,119 1,581 8,482
Research and development expenses (1,153) (848) (4,181)
Selling, general and administrative expenses (452) (201) (1,283)
Operating expenses (1,605) (1,049) (5,464)
Operating profit 514 532 3,018
Net financial items 98 892 965
Net profit 465 1,096 3,008
Balance Sheet
Marketable securities 10,917 10,191 10,381
Cash and cash equivalents 9,071 7,892 8,957
Total non-current assets 1,739 2,273 1,891
Total assets 24,914 22,210 24,627
Shareholders' equity 22,719 20,095 22,196
Share capital 66 66 66
Cash Flow Statement
Cash flow from operating activities 587 1,185 2,228
Cash flow from investing activities (667) (579) (961)
Cash flow from financing activities (64) (220) (420)
Investment in tangible assets (57) (28) (252)
Financial Ratios
Basic net profit per share 7.10 16.76 46.00
Diluted net profit per share 7.05 16.61 45.54
Period-end share market price 2,465 2,087 2,630
Price / book value 7.16 6.85 7.82
Shareholders' equity per share 344.23 304.47 336.30
Equity ratio 91 % 90 % 90 %
Shares outstanding 65,734,141 65,587,322 65,718,456
Average number of employees (FTE*) 1,285 842 1,022
Number of employees (FTE) at the end of the period 1,309 871 1,212
* Full-time equivalent or team members
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 4/34
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Quarter of 2022
Revised Previous
(DKK million) Guidance Guidance
Revenue 11,000 - 12,000 10,800 - 12,000
Operating expenses (7,200) - (7,800) (7,200) - (7,800)
Operating profit 3,200 - 4,800 3,000 - 4,800
Genmab is updating the lower end of its 2022 financial guidance published on February 16, 2022, driven by increased royalty revenue related to net sales of DARZALEX.
Genmab expects its 2022 revenue to be in the range of DKK 11,000 - 12,000 million, an increase to the lower end of the previous guidance of DKK 10,800 - 12,000 million, driven primarily by the continued strong growth of DARZALEX net sales. Genmab's projected revenue for 2022 primarily consists of DARZALEX royalties of DKK 8,000 - 8,500 million compared to previous guidance of DKK 7,700 - 8,500. Such royalties are based on Genmab's revised estimate of DARZALEX 2022 net sales of USD 7.5 - 8.0 billion compared to previous guidance of USD 7.3 - 8.0 billion. DARZALEX royalties are partly offset by the impact of Janssen's withholding of a portion of royalty payments related to Genmab's share of Janssen's royalty payments to Halozyme in connection with SC sales. The remainder of Genmab's revenue consists of royalties from TEPEZZA, Kesimpta and RYBREVANT , reimbursement revenue, milestones for epcoritamab, teclistamab and other milestones as well as collaboration revenue with Seagen for Tivdak.
Genmab anticipates its 2022 operating expenses to continue to be in the range of DKK 7,200 - 7,800 million. Operating expenses continue to be driven by the advancement of Genmab's clinical programs, continued investment in research and development, as well as building Genmab's commercial organization and broader organizational infrastructure.
Genmab now expects its 2022 operating result to be in the range of DKK 3,200 - 4,800 million, an increase to the lower end of the previous guidance of DKK 3,000 - 4,800 million, driven primarily by the increase in royalty revenue related to the net sales of DARZALEX.
Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to, the achievement of certain milestones associated with Genmab's collaboration agreements; the timing and variation of development activities (including activities carried out by Genmab's collaboration partners) and related income and costs; DARZALEX, Kesimpta, TEPEZZA and RYBREVANT net sales and royalties paid to Genmab; and currency exchange rates (the 2022 guidance assumes a USD / DKK exchange rate of 6.4). The financial guidance assumes that no significant new agreements are entered into during the remainder of 2022 that could materially affect the results. Refer to the section "Significant Risks and Uncertainties" in this interim report. Additionally, depending on trends related to the coronavirus and future variants, the COVID-19 pandemic could potentially have a material adverse impact on Genmab's business and financial performance, including clinical trials, projected regulatory approval timelines, supply chain and revenues, and cause Genmab's actual results to differ materially from 2022 Guidance and Key 2022 Priorities in this interim report.
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 5/34
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Quarter of 2022
Should the global outbreak of COVID-19 persist, it may have long-term impacts on the development, regulatory approval and commercialization of Genmab's investigational medicines and on net sales of approved medicines created by Genmab and developed and marketed by Genmab or Genmab's collaboration partners. As the pandemic continues, there may be an impact on Genmab's business. Genmab has an established COVID-19 response team, led by the CEO, that closely monitors the evolving situation, maintains precautionary measures to help limit the impact of COVID-19 at the workplace and on our communities, and ensures business continuity. The full extent and nature of the impact of the COVID-19 pandemic and related containment measures on Genmab's business and financial performance is uncertain as the situation continues. The factors discussed above, as well as other factors that are currently unforeseeable, may result in further and other unforeseen material adverse impacts on Genmab's business and financial performance, including on the sales of Tivdak and on net sales of DARZALEX, Kesimpta, TEPEZZA and RYBREVANT by Genmab's partners and on Genmab's royalty and milestone revenue therefrom.
Priority Targeted Milestones
Broad and rapid development of late-stage clinical pipeline and further build US country organization Epcoritamab 1 Expand clinical development program with multiple Phase 3 trials initiated and submission of first BLA (subject to supportive FDA feedback)
Tivdak 2 Establish Tivdak as a clear choice for 2L+ r/m Cervical Cancer patients Broaden clinical development program including Phase 2 evaluation of combination therapy in earlier line treatment for cervical cancer and other solid tumors
Growth and development of differentiated early-stage product candidates DuoBody-PD-L1x4-1BB 3 & DuoBody-CD40x4-1BB 3 Data from clinical expansion cohorts to progress to next steps
Expand and advance proprietary clinical product portfolio
Further scale organization aligned with growing product portfolio and brand needs Further scale organization aligned with differentiated antibody product portfolio growth and future launches
Use solid financial base to grow and broaden antibody product and technology portfolio
1. Co-development w/ AbbVie; 2. Co-development w/ Seagen Inc. (Seagen); 3. Co-development w/ BioNTech SE (BioNTech)
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST QUARTER OF 2022
At the end of the first quarter of 2022, Genmab's proprietary pipeline of investigational medicines, where we are responsible for at least 50% of development, consisted of seven antibody products in clinical development. These include Genmab's first U.S. FDA approved medicine, Tivdak, which Genmab is co-developing and co-promoting in the U.S. with Seagen. In addition to our own pipeline, there are multiple investigational medicines in development by global pharmaceutical and biotechnology companies, including four approved medicines powered by Genmab's technology and innovations. Beyond the
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 6/34
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Quarter of 2022
investigational medicines in clinical development, our pipeline also includes multiple preclinical programs. An overview of the development status of each of our investigational medicines is provided in the following sections. Detailed descriptions of dosing, efficacy and safety data from certain clinical trials have been disclosed in company announcements and media releases published via the Nasdaq Copenhagen stock exchange and may also be found in Genmab's filings with the U.S. Securities and Exchange Commission (SEC). Additional information is available on Genmab's website, www.genmab.com. The information accessible through our website is not part of and is not incorporated by reference herein.
Genmab Proprietary Investigational Medicines1 in Development
1Investigational medicines where Genmab has 50% ownership. Certain investigational medicines in co-development, partners as indicated
2See U.S. prescribing information for precise indication and safety information
3Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen
Tivdak (tisotumab vedotin-tftv) - First and only U.S. FDA approved antibody-drug conjugate (ADC) for recurrent or metastatic cervical cancer
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
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1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Quarter of 2022
Tivdak is an ADC composed of Genmab's human monoclonal antibody directed to TF and Seagen's ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E to the antibody. Genmab used technology licensed from Medarex to generate the TF antibody forming part of Tivdak. Tivdak is the first and only U.S. FDA approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tivdak is being co-developed by Genmab and Seagen. Under a joint commercialization agreement, Genmab is co-promoting Tivdak in the U.S. and will lead commercial operational activities in Japan. Seagen is leading commercial operational activities in the U.S. and will lead commercial operational activities in Europe and China. In these four markets there will be a 50:50 cost and profit split. In any other markets, Seagen will commercialize Tivdak and Genmab will receive royalties based on a percentage of aggregate net sales ranging from the mid-teens to the mid-twenties. The companies have joint decision-making on the worldwide development and commercialization strategy for Tivdak. The companies have a broad clinical development program for Tivdak, including a confirmatory Phase 3 study in recurrent or metastatic cervical cancer.
Please consult the U.S. Prescribing Information for Tivdak for the labeled indication and safety information, including the boxed warning.
First Quarter 2022 Updates
Epcoritamab (DuoBody-CD3xCD20) - Potential Best-in-class Investigational Medicine
Epcoritamab is a proprietary bispecific antibody created using Genmab's DuoBody technology platform. Epcoritamab targets CD3, which is expressed on T-cells, and CD20, a clinically well-validated target on malignant B-cells. Genmab used technology licensed from Medarex to generate the CD20 antibody forming part of epcoritamab. Epcoritamab is being co-developed by Genmab and AbbVie. The first Phase
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 8/34
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Quarter of 2022
3 clinical study (NCT04628494) of epcoritamab in relapsed / refractory DLBCL is ongoing. In addition, Phase 1/2 clinical studies in B-cell non-Hodgkin lymphoma (B-NHL) including chronic lymphocytic leukemia (NCT04623541) and in combination with standard of care therapies for B-NHL (NCT04663347) are ongoing. The combination of epcoritamab and DuoHexaBody -CD37 (GEN3009) is also being explored in an arm of a Phase 1/2 clinical study (NCT04358458) of DuoHexaBody-CD37 in hematologic malignancies.
First Quarter 2022 Update
DuoBody-PD-L1x4-1BB (GEN1046) - Bispecific Next Generation Checkpoint Immunotherapy
DuoBody-PD-L1x4-1BB (GEN1046) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab's DuoBody technology platform. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and profits for DuoBody-PD-L1x4-1BB on a 50:50 basis. DuoBody-PD-L1x4-1BB is designed to induce an antitumor immune response by simultaneous and complementary PD-L1 blockade and conditional 4-1BB stimulation using inert DuoBody antibody format. Three clinical studies in solid tumors are ongoing including a Phase 2 study of DuoBody-PD-L1x4-1BB as monotherapy or in combination with pembrolizumab in patients with recurrent metastatic NSCLC (NCT05117242).
DuoBody-CD40x4-1BB (GEN1042) - Potential First-in-Class Bispecific Agonistic Antibody
DuoBody-CD40x4-1BB (GEN1042) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab's DuoBody technology platform. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and profits for DuoBody-CD40x4-1BB on a 50:50 basis. CD40 and 4-1BB were selected as targets to enhance both dendritic cells and antigen-dependent T-cell activation, using an inert DuoBody format. A Phase 1/2 clinical study of DuoBody-CD40x4-1BB in solid tumors is ongoing (NCT04083599).
DuoHexaBody-CD37 (GEN3009) - First DuoHexaBody Program in the Clinic
DuoHexaBody-CD37 (GEN3009) is a bispecific antibody that targets two non-overlapping CD37 epitopes, created using Genmab's DuoHexaBody technology platform. The DuoHexaBody technology platform combines the dual targeting of our DuoBody technology platform with the enhanced potency of our
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
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Interim Report for the First Quarter of 2022
HexaBody technology platform, creating bispecific antibodies with target-mediated enhanced hexamerization. DuoHexaBody-CD37 is being co-developed by Genmab and AbbVie. A Phase 1/2 clinical study (NCT04358458) in hematologic malignancies, including an arm in combination with epcoritamab, is ongoing.
HexaBody-CD38 (GEN3014) - HexaBody Molecule with Potential in Hematological Malignancies
HexaBody-CD38 (GEN3014) is a human CD38 monoclonal antibody-based investigational medicine created using Genmab's HexaBody technology platform. In preclinical models of hematological malignancies HexaBody-CD38 demonstrated highly potent complement-dependent cytotoxicity and showed potent anti-tumor activity. In June 2019, Genmab entered into an exclusive worldwide license and option agreement with Janssen to develop and commercialize HexaBody-CD38. A Phase 1/2 clinical study (NCT04824794) in hematologic malignancies is ongoing.
DuoBody-CD3xB7H4 (GEN1047) - Most Recent Investigational Medicine in the Clinic
DuoBody-CD3xB7H4 (GEN1047) is a bispecific antibody-based investigational medicine created using Genmab's DuoBody technology platform. B7H4 is an immune checkpoint protein expressed on malignant cells in various solid cancers including breast, ovarian and lung cancer. In preclinical studies, DuoBody-CD3xB7H4 induced T-cell mediated cytotoxicity of B7H4-positive tumor cells. DuoBody-CD3xB7H4 is being developed for the potential treatment of solid cancer indications known to express B7H4. A Phase 1/2 clinical study (NCT05180474) of DuoBody-CD3xB7H4 in malignant solid tumors is ongoing.
First Quarter 2022 Update
Products Powered by Genmab's Technology and Innovations
In addition to Genmab's own pipeline of investigational medicines, our innovations and proprietary technology platforms are applied in the pipelines of global pharmaceutical and biotechnology companies. These companies are running clinical development programs with antibodies created by Genmab or created using Genmab's proprietary DuoBody bispecific antibody technology platform. The programs run from Phase 1 development to approved medicines. The tables in this section include those therapies that have been approved in certain territories as well as clinical stage investigational medicines in Phase 2 development or later. Under the agreements for these products Genmab is entitled to certain potential milestones and royalties.
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Interim Report for the First Quarter of 2022
*See local country prescribing information for precise indications and safety information
DARZALEX (daratumumab) - Redefining the Treatment of Multiple Myeloma
DARZALEX is a human monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells and is also expressed by AL amyloidosis plasma cells. Genmab used technology licensed from Medarex to generate the CD38 antibody forming part of daratumumab. Daratumumab is being developed by Janssen under an exclusive worldwide license from Genmab to develop, manufacture and commercialize daratumumab. Under the terms of the agreement, Genmab is entitled to double digit royalties between 12% and 20%. Daratumumab (marketed as DARZALEX for IV administration and as DARZALEX FASPRO in the United States and as DARZALEX SC in Europe for SC administration) is approved in a large number of territories for the
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 17
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Interim Report for the First Quarter of 2022
treatment of adult patients with certain multiple myeloma indications and is the only approved therapy in the U.S., Europe and Japan for the treatment of adult patients with AL amyloidosis.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for DARZALEX and DARZALEX SC and the U.S. Prescribing Information for DARZALEX FASPRO for the labeled indication and safety information.
Kesimpta (ofatumumab) - Approved in treatment of relapsing forms of multiple sclerosis (RMS)
Kesimpta is a human monoclonal antibody that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. Genmab used technology licensed from Medarex to generate the CD20 antibody forming part of Kesimpta. Kesimpta is approved in territories including the U.S., Europe and Japan for the treatment of certain adult patients with RMS. Kesimpta is the first B-cell therapy that can be self-administered by patients at home using the Sensoready autoinjector pen, once monthly after starting therapy. Kesimpta is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis. Under the terms of the agreement, Genmab is entitled to 10% royalties on net sales of Kesimpta.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for the labeled indication and safety information for Kesimpta.
TEPEZZA (teprotumumab-trbw) - First U.S. FDA-approved medicine for the treatment of thyroid eye disease (TED)
Teprotumumab, approved by the U.S. FDA under the trade name TEPEZZA, is a human monoclonal antibody that targets the Insulin-like Growth Factor 1 Receptor (IGF-1R), a well-validated target. Genmab used technology licensed from Medarex to generate the IGF-1R antibody forming part of teprotumumab. The antibody was created by Genmab under a collaboration with Roche and development and commercialization of the product is now being conducted by Horizon under a sublicense from Roche. Under the terms of Genmab's agreement with Roche, Genmab will receive mid-single digit royalties on sales of TEPEZZA.
Please consult the U.S. Prescribing Information for the labeled indication and safety information for TEPEZZA.
RYBREVANT (amivantamab-vmjw) - First regulatory approvals for a DuoBody-based Medicine
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Interim Report for the First Quarter of 2022
In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab's DuoBody technology platform. The most advanced of these, Janssen's RYBREVANT, is a fully human bispecific antibody that targets epidermal growth factor receptor (EGFR) and Met, two validated cancer targets. The two antibody libraries used to produce amivantamab were both generated by Genmab. In collaboration with Janssen, the antibody pair used to create amivantamab was selected. Janssen is responsible for the development of amivantamab.
In 2021, Janssen received approvals in the U.S., Europe and other markets for RYBREVANT for the treatment of certain adult patients with NSCLC with EGFR exon 20 insertion mutations. These are the first regulatory approvals for a therapy that was created using Genmab's proprietary DuoBody bispecific technology platform. Under our agreement with Janssen, Genmab will receive milestones and royalties between 8% and 10% on net sales of RYBREVANT.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for RYBREVANT for the labeled indication and safety information.
Clinical Stage Investigational Medicines, >Phase 2 Development
*UltiMab transgenic mouse technology licensed from Medarex, Inc., a wholly owned subsidiary of Bristol Myers Squibb.
Preclinical Programs
Our preclinical pipeline includes immune effector function enhanced antibodies developed with our HexaBody technology platform and bispecific antibodies created with our DuoBody technology platform. We are also working with our partners to generate additional new antibody-based product concepts. A number of the preclinical programs are carried out in cooperation with our collaboration partners.
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Last updated: May 11, 2022