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Registered Number 11185179 (England & Wales)
Annual Report and Accounts
the year ended 31 December 2020
Autolus Therapeutics pie
AUTOLUS THERAPEUTICS PLC
Introduction and Contents
Autolus Therapeutics pie (the
Company , or Parent Company ) is a public limited company incorporated under the laws of England and Wales and is listed on the Nasdaq Global Select Market ( NASDAQ ). The Company is a quoted company for
the purposes of the Companies Act 2006 (the Companies Act ).
This document (the Annual Report and Accounts ) is comprised of the
reports and consolidated financial statements listed below and the Annual Report on Form 20-F (the Form 20-F ) filed with the United States Securities and
Exchange Commission (the SEC ) on 4 March 2021. For purposes of this Annual Report and Accounts, the exhibits to the Form 20-F are not incorporated by reference.
On 25 April 2019, the Company changed its accounting reference date from 30 September to 31 December, thereby extending the reporting period by
three months. Due to this change in the prior fiscal period, this Annual Report and Accounts covers a 12-month period beginning on 1 January 2020 and ending on 31 December 2020, with a comparative
period of 15 months, beginning on 1 October 2018 and ending on 31 December 2019.
In this Annual Report and Accounts, unless the context
otherwise indicates, references to the Group , Autolus , we , us or our include the Company and its wholly-owned subsidiaries.
| Company Information | 3 | |||
| Strategic Report | 4 | |||
| Directors Report | 11 | |||
| Directors Remuneration Report | 18 | |||
| Independent Auditor s Report to the Members of Autolus Therapeutics plc | 43 | |||
| Consolidated Income Statement for the 12 months ended 31 December 2020 | 51 | |||
| Consolidated Balance Sheet | 52 | |||
| Consolidated Cash Flow Statement | 53 | |||
| Consolidated Statement of Changes in Equity | 54 | |||
| Notes to the Consolidated Financial Statements | 55 | |||
| Parent Company Balance Sheet | 82 | |||
| Parent Company Statement of Changes in Equity | 83 | |||
| Notes to the Parent Company Financial Statements | 84 |
AUTOLUS THERAPEUTICS PLC
| Directors | Martin Murphy, Chairman of the Board of Directors | |
| Christian ltin, Director and CEO | ||
| Joseph Anderson | ||
| Jay Backstrom | ||
| Linda Bain | ||
| John Berriman | ||
| Cynthia Butitta | ||
| Kapil Dhingra | ||
| Secretary | Matthias Alder | |
| Registered Office | Forest House | |
| 58 Wood Lane | ||
| London W12 7RZ | ||
| United Kingdom | ||
| Registered Number | 11185179 | |
| Auditors | Ernst & Young LLP | |
| Apex Plaza | ||
| Forbury Road | ||
| Reading RGl lYE | ||
| United Kingdom | ||
| Bankers | Barclays Bank | |
| 1 Church Street | ||
| Peterborough PEl lXE | ||
| United Kingdom | ||
| Solicitors | Cooley (UK) LLP | |
| Dashwood | ||
| 69 Old Broad Street | ||
| London EC2M lQS | ||
| United Kingdom |
AUTOLUS THERAPEUTICS PLC
For the 12 months ended 31 December
Strategic Review Note
The directors ( Directors ) present their strategic report on the affairs of the Group (the Strategic Report ), together with the
financial statements for the 12 months ended 31 December 2020.
We are a biopharmaceutical company developing next generation programmed T cell therapies for the treatment of cancer. Using our broad suite of proprietary and
modular T cell programming technologies, we are engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defence mechanisms and eliminate these cells. We
believe our programmed T cell therapies have the potential to be best-in-class and offer cancer patients substantial benefits over the existing standard of care,
including the potential for cure in some patients.
We are registered with the Registrar of Companies in England and Wales under number 11185179, and our
registered office is at Forest House, 58 Wood Lane, White City, London W12 7RZ, United Kingdom.
Development of the Group
Autolus Therapeutics pie is a public limited company under the laws of England and Wales, originally incorporated under the laws of England and Wales in
February 2018 as a private limited company called Autolus Therapeutics Limited. Autolus Limited was originally incorporated under the laws of England and Wales in July 2014. Pursuant to the terms of our corporate reorganisation, the shareholders of
Autolus Limited exchanged each of the shares held by them in Autolus Limited for the same number and class of newly issued shares of Autolus Therapeutics Limited and, as a result, Autolus Limited became a wholly owned subsidiary of Autolus
Therapeutics Limited. On 18 June 2018, Autolus Therapeutics Limited re-registered as a public limited company and was renamed Autolus Therapeutics pie. On 22 June 2018, our outstanding preferred and
ordinary shares were converted into a single class of ordinary shares and various classes of deferred shares, and we completed our initial public offering of American Depositary Shares ( ADS ), each representing one of our ordinary
On 25 April 2019, the Company changed its accounting reference date from 30 September to 31 December, thereby extending
the reporting period by three months. Due to this change in the prior financial reporting period, this Annual Report and Accounts covers a 12-month period beginning on 1 January 2020 and ending on
31 December 2020, with a comparative period of 15 months, beginning on 1 October 2018 and ending on 31 December 2019.
and has not been listed or had any securities listed in the U.K. or the European Union. To meet US reporting requirements, the Group is required to file periodic reports, including an annual report on Form
20-F ( 20-F ) with the United States Securities and Exchange Commission ( SEC ). The financial statements included in the 20-F are prepared in accordance with accounting principles generally accepted in the United States ( US GAAP ). These US GAAP financial statements have a reporting currency of U.S. Dollars.
To meet United Kingdom ( UK ) statutory reporting requirements, the Company is required to file this Annual Report and Accounts with Companies House
in the UK. The financial statements, which are included in this Annual Report and Accounts, are prepared in accordance with frozen EU-adopted International Financial Reporting Standards ( IFRS )
using the functional currency of Pounds sterling. Due to the fact that much of the information required for the 20-F, which is filed with the SEC, and Annual Report and Accounts are the same, where the
requirements of the Strategic Report and the Directors Report in accordance with the Companies Act have been met in the 20-F, details of this have been provided in table below and referenced to the 20-F accordingly. Additional requirements which are not met by the 20-F have been disclosed separately in each of the sections of this Annual Report and Accounts. The prior
year s 20-F, which includes a full set of financial statements for the comparative period of 1 October 2018 to 31 December 2019, was filed with the SEC on 4 March 2020. The current year 20-F, which included a full set of financial statements for the 12 months ending 31 December 2020, was filed with the SEC on 4 March 2021 and is included in Appendix 1.
AUTOLUS THERAPEUTICS PLC
For the 12 months ended 31 December
The following table provides a guide to the
20-F content used for this report:
| Required item in the Strategic Report | Where the information can be found in the 20-F | |
| A fair review of the Group s business, including the use of key performance indicators ( KPI s ) | Part I: Item 4. Information on the Company Part I: Item 5. Operating and Financial Review and Prospects The Company has not utilised traditional KPI s as there were no sales, an immaterial amount of out-licensing revenue, and no production of products for commercial sale in the 12 months ended 31 December 2020. The financial information reported in our 20-F is prepared in accordance with US GAAP and is the primary information reported to shareholders. Whilst different to the audited financial information reported in accordance with frozen EU-adopted International Financial Reporting Standards included in this Annual Report and Accounts, we believe the information to be helpful as the Board use the US GAAP information when communicating with shareholders, other stakeholders and the market generally. | |
| A description of the principal risks and uncertainties | Part I: Item 3D. Risks A summary of the principal risks is included below under the principal risk heading on page 9. | |
| Description of the Group s strategy | Part I: Item 4B. Business overview, and in particular: | |
| Development Strategy for Adult ALL | ||
| Development Strategy for Paediatric ALL | ||
| Development Strategy for Adult DLBCL | ||
| Development Strategy for AUTO4 | ||
| Clinical Development Strategy of AUTO6NG | ||
| Description of the Group s business model | Part I: Item 4B. Business Overview Part I: Item 4C. Organization Structure | |
| Main trends and factors likely to affect future development, performance and position of the Group s business | Part I: Item 4B. Business Overview Part I: Item 5A. Operating Results Part I: Item 5B. Liquidity and Capital Resources See also the Financial review section below | |
| Finance Review | See disclosure below | |
| Corporate governance | Part I: Item 6C. Composition of Our Board of Directors | |
| Information on environmental, diversity, equality, and human rights | See disclosures below | |
| Principal risks and mitigations related to COVID-19 | See disclosures below |
our inception in July 2014, we have devoted substantially all our resources to conducting preclinical studies and clinical trials, organizing and staffing our company, business planning, raising capital and establishing our intellectual property
portfolio. We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations to date primarily with sales of our equity securities. As of 31 December 2020, we had received net
proceeds of 395.8 million from sales of our equity securities, including a follow-on raise on 27 January 2020 in which we closed an underwritten public offering of our ADS which resulted
in net proceeds after underwriting discounts of 57.4 million.
In September 2020, we entered into an Open Market Sale AgreementSM, or the Sales Agreement, with Jefferies LLC, or Jefferies, where we may offer and sell ADSs having an aggregate offering price of up to $100 million from time to time through Jefferies, acting
as sales agent. As of the date of this Annual Report, we have sold an aggregate of 1.7 million of our ADSs resulting in net proceeds of 11.3 million. Further, in February 2021, we closed an underwritten public offering of 16,428,572
ADSs, including the exercise in full by the underwriters of
AUTOLUS THERAPEUTICS PLC
For the 12 months ended 31 December
their option to purchase an additional 2,142,857 ADSs, at a public offering
price of $7.00 per ADS. We received net proceeds of 78.2 million after underwriting discounts. We do not expect to generate significant revenue unless and until we obtain marketing approval for and commercialise one of our product
Since our inception, we have incurred significant operating losses. For the 12 months ended 31 December 2020 and the 15 months ended
31 December 2019, we incurred net losses of 113.1 million and 113.5 million, respectively. As of 31 December 2020, we had a retained loss of 62.7 million.
Research and development expenses were 103.6 million for the 12 months ended 31 December 2020 as compared to 91.0 million for the
15 months period ended 31 December 2019, an increase of 12.7 million. The increase is mainly related to an increase of employee and compensation costs of 6.0. million due to an increase in employee headcount to support the
advancement of our product candidates in clinical development, 1.0 of project cost as a consequence of the advancement of our clinical portfolio which includes research and process development and manufacturing activities necessary to
prepare, activate, and monitor clinical trial programs, 2.0 million of facilities cost related to the commencement of a lease for an additional manufacturing suite and the continued scaling of manufacturing operations,
2.0 million of IT infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations, and 1.0 million of cell logistics, offset by a decrease of 2.0 million
in materials purchases.
Administrative expenses were 27.6 million for the 12 months ended 31 December 2020 as compared to
41.3 million for the 15 months ended 31 December 2019, an decrease of 13.7 million, which is mainly related to the impact of the 12 months of expense this year versus the 15 month period comparative. However,
notable differences include a reduction in the share based payment expense of 7.7 million due to lower number of awards and fair value of awards granted and a reduction in travel cost of 1.0 million due to the impact of the COVID-19 pandemic.
We expect to continue to incur significant expenses for the foreseeable future as we advance our
product candidates through preclinical and clinical development, seek regulatory approval and pursue commercialization of any approved product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to
incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. In addition, we may incur expenses in connection with the in-licence or acquisition of
additional product candidates. Furthermore, we have incurred and expect to continue to incur, additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can
generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic
transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favourable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to
significantly delay, scale back or discontinue the development and commercialization of one or more of our drug candidates or delay our pursuit of potential in-licences or acquisitions.
As of 31 December 2020, we had cash and cash equivalents of 112.8 million. Based on our current clinical development plans, we believe our
existing cash, along with the additional net proceeds of 89.5 million from sale of our ADSs under our at-the market facility program in January 2021 and our
follow-on capital raise in February 2021 will be able to fund our current and planned operating expenses and capital expenditure requirements through at least the next 12 months from the date of this Annual
Report. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our available capital resources sooner than we expect.
Business Update: COVID-19 Response, Program Prioritization and Corporate Adjustments
With the ongoing coronavirus 2019, or COVID-19, pandemic, we established a cross-functional task force and have
implemented business continuity plans designed to address and mitigate its impact on our employees and business. While we have not experienced any significant financial impact to date, the overall disruption caused by the COVID-19 pandemic on global healthcare systems, and the other risks and uncertainties associated with the pandemic, could cause our business, financial condition, results of operations and growth prospects to be
materially adversely affected.
AUTOLUS THERAPEUTICS PLC
For the 12 months ended 31 December
In March 2020, our global workforce transitioned to working remotely with the
exception of research and clinical trial related activities that required laboratory-based activity or manufacturing. We implemented protocols and procedures to ensure the safety of our employees working on site, including requirement to wear
personal protective equipment, temperature checks at entry and offered COVID-19 testing for any employee with symptoms or at suspected risk of exposure to virus. In June 2020, we began the implementation of
our workplace re-entry plan, based on a phased approach that is principles-based and local in design, with a focus on continuity of patient treatment and working to bring its workforce back on-site safely. We have also implemented policies to control and limit office and lab access in line with social distancing guidelines and for contact tracing if needed.
We continue to track COVID-19 developments in Europe and the United States closely for their potential impact on our
clinical trial sites, logistics and supply chain to ensure we can continue to maintain clinical trial conduct and data integrity. As the patients in our clinical trials are severely immune suppressed as a consequence of their underlying disease and
the treatment they receive in the trials, we are also monitoring other transmissible infectious diseases, including influenza.
announced the prioritization of the AUTOl program and our intention to seek a partner for the AUTO3 program before progressing AUTO3 into its next phase of development. We also announced an adjustment of our workforce and infrastructure footprint