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Registered Number 11185179 (England & Wales)
Annual Report and Accounts
the Year Ended 30th September 2018
Autolus Therapeutics plc
| Page | ||||||
| 1. | Company Information | 3 | ||||
| 2. | Group Strategic Report | 4 | ||||
| 3. | Report of Directors | 61 | ||||
| 4. | Directors Remuneration report | 64 | ||||
| 5. | Report of the Independent Auditors | 86 | ||||
| 6. | Income Statement | 92 | ||||
| 7. | Balance Sheet | 93 | ||||
| 8. | Consolidated Statement of Changes in Equity | 94 | ||||
| 9. | Consolidated Cash Flow Statement | 95 | ||||
| 10. | Notes to the Consolidated Financial Statements | 96 | ||||
| 11. | Parent Company Financial Statements | 116 | ||||
| 12. | Parent Company Statement of Changes in Equity | 117 | ||||
| 13. | Notes to the Parent Company Financial Statements | 118 |
| Directors | Christian Itin, Chairman of the Board of Directors Joseph Anderson, Director | |
| Linda Bain, Director John Berriman, Director Cynthia Butitta, Director Kapil Dhingra, Director Martin Murphy, Director | ||
| Secretary | Matthias Alder | |
| Registered Office | Forest House | |
| 58 Wood Lane London W12 7RZ England | ||
| Registered Number | 11185179 | |
| Auditors | Ernst & Young LLP Apex Plaza Forbury Road Reading | |
| RG1 1YE | ||
| Bankers | Barclays Bank | |
| 1 Church Street Peterborough PE1 1XE | ||
| Solicitors | Cooley (UK) LLP Dashwood | |
| 69 Old Broad Street | ||
| London EC2M 1QS |
As used in this Annual Report, unless the context otherwise indicates, the terms Group ,
Autolus , we , us and our refer to Autolus Therapeutics plc and its wholly-owned subsidiaries.
Strategic Review Note
directors ( Directors ) present their strategic report on the affairs of Autolus Therapeutics plc (the Company ), together with the financial statements for the year ended 30th September 2018.
Autolus Therapeutics plc 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 June 18, 2018, Autolus Therapeutics Limited re-registered as a public limited company and was renamed Autolus
Therapeutics plc. On June 22, 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 ( ADSs ), each representing one of our ordinary shares, on the Nasdaq Global Select Market.
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.
General Business Review
Cancers thrive on their ability
to fend off T cells by evading recognition by T cells and by establishing other defence mechanisms, such as checkpoint inhibition and creating a hostile microenvironment. Our next-generation T cell programming technologies allow us to tailor our
therapies to address the specific cancer we are targeting and introduce new programming modules into a patient s T cells to give those T cells improved properties to better recognise cancer cells and overcome fundamental cancer defence
mechanisms. We believe our leadership in T cell programming technologies will provide us with a competitive advantage as we look to develop future generations of T cell therapies targeting both haematological cancers and solid tumours.
Our clinical-stage pipeline comprises five programs being developed in six haematological and solid tumour indications. We expect to complete the
proof-of-concept phases of four Phase 1/2 clinical trials in haematological cancer indications in 2019. These clinical programs are adaptive and designed to allow collection of sufficient data in the expansion phase of the trials to potentially
support registration. We have worldwide commercial rights to all our programmed T cell therapies.
Our goal is to use our broad array of proprietary and
modular T cell programming technologies to become a fully integrated biopharmaceutical company offering advanced, differentiated, best-in-class programmed T cell therapies. In order to accomplish this goal, we plan to execute on the following key
The Company is a public limited company
incorporated under the laws of England and Wales. On June 15, 2018, the Company completed the first step of a corporate reorganisation, pursuant to which the shareholders of Autolus Limited, a private company originally incorporated under the laws
of England and Wales in July 2014 as NewIncCo 1311 Limited which subsequently changed its name to Autolus Limited in August 2014, exchanged each of the different classes of shares held by them in Autolus Limited for the same number and class of
newly issued ordinary shares of Autolus Therapeutics Limited. As a result, Autolus Limited became a wholly owned subsidiary of Autolus Therapeutics Limited, a holding company incorporated in February 2018 with nominal assets and liabilities, which
had not conducted any operations prior to the share exchange and other actions incidental to the exchange and its incorporation.
Limited becoming a wholly owned subsidiary of Autolus Therapeutics Limited, Autolus Therapeutics Limited transferred the entire issued share capital of Autolus Limited to Autolus Holdings (UK) Limited. On June 18, 2018, as the second step of the
corporate reorganisation, Autolus Therapeutics Limited re-
registered as a public limited company and its name was changed from Autolus Therapeutics Limited to Autolus Therapeutics plc. Following the re-registration of Autolus Therapeutics Limited as a
public limited company, Autolus Limited completed a reduction in its issued share capital pursuant to Part 17 of the Companies Act by way of the cancellation of all of its issued series A preferred shares, C ordinary shares, deferred shares and all
but 100 B ordinary shares.
On June 22, 2018, the different classes of the Company s issued share capital were converted into a single class of
ordinary shares and the Company completed its initial public offering ( IPO ) of ADSs. In the IPO, the Company sold an aggregate of 10,147,059 ADSs representing the same number of ordinary shares, including 1,323,529 ADSs pursuant to the
underwriters option to purchase additional ADSs, at a public offering price of $17.00 per ADS. Net proceeds were approximately 117.5 million, after deducting underwriting discounts and commissions and offering expenses paid by the
Autolus Therapeutics plc is a continuation of Autolus Limited and its subsidiaries, and the corporate reorganisation has been accounted for as a
combination of entities under common control. The corporate reorganisation has been given retrospective effect in these financial statements and such financial statements represent the financial statements of Autolus Therapeutics plc. In connection
with the corporate reorganisation, outstanding restricted share awards and option grants of Autolus Limited were exchanged for share awards and option grants of Autolus Therapeutics plc with identical restrictions.
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by
competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently
under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialisation. These efforts require significant amounts of capital, adequate
personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company s product development efforts are successful, it is uncertain when, if ever, the Company will realise revenue from its product sales.
The Company has funded its operations primarily with proceeds from the sale of its equity securities. The Company has incurred recurring losses since its
inception, including net losses of 31.1 million, 15.6 million for the years ended September 30, 2018 and 2017 respectively. In addition, as of September 30, 2018. The Company expects to continue to generate operating losses
for the foreseeable future. The future viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its operations. The Company s inability to raise additional capital as and when needed could
have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable
to the Company, or at all. The Company believes the cash on hand at September 30, 2018 of 189.3 million will be sufficient to fund the Company s operations for at least 12 months from the issuance date of these financial statements.
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, including the net proceeds from our recently completed IPO in June 2018. Through September
30, 2018, we have received net proceeds of 255.3 million from sales of our equity securities. 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 years ended September 30, 2018, 2017, we incurred net losses of
31.1 million, 15.6 million, respectively. As of September 30, 2018, we had retained earnings of 163.8 million, which reflect the capital reduction of 222.1 million, offset by our accumulated losses of
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 commercialisation of any approved product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant
commercialisation expenses related to product manufacturing,
marketing, sales and distribution. In addition, we may incur expenses in connection with the in-license 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 that we did not incur as a private company.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until 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 commercialisation of one or more of our drug candidates or delay our pursuit of potential in-licenses or acquisitions.
As of September 30, 2018, we had cash and cash equivalents of 189.3 million. Based on our current clinical development plans, we believe our
existing cash and cash equivalents will be able to fund our current and planned operating expenses and capital expenditure requirements into calendar year 2021. 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.
Key performance indicators
Autolus creates companywide monthly flash report analysing actual performance vs budget. We perform analysis of key cost drivers (overhead, project specific,
FTE analysis, growth trend) to monitor company growth and manage cashflow. Also, employee cost increase analysis vs. non-employee costs are performed to determine productivity by department. In addition, cash movement analysis and the impact of
foreign exchange on our cash balance is reviewed.
Environmental matters
The Group leases all of its facilities, manufactures its own products for the ongoing clinical studies, and stores finished goods. However, due to the small
number of patients for which product is being manufactured, these activities have a very minimal environmental impact. The Group complies with all applicable environmental laws and regulations, but as of this time it does not have a large
environmental footprint.
Following listing in June 2018, Autolus Therapeutics plc is required to measure and report its greenhouse gas emissions in
accordance with the provisions of the Companies Act 2006 (Strategic Report and Directors Report) Regulations 2013. The greenhouse gas emissions report period will be aligned to the financial reporting year and as such the first year will be
reported as the baseline year against which future performance will be measured. Therefore, no report is included in these financial statements for the short period between public listing in June 2018 and September 2018.
Appointments within the Group are made on
merit according to the balance of skills and experience offered by prospective candidates. Whilst acknowledging the benefits of diversity, individual appointments are made irrespective of personal characteristics such as race, disability, gender,
sexual orientation, religion or age. A breakdown of the employment statistics as of 30 September 2018 is as follows:
| Position | Male | Female | Total | |||||||||
| Executive | 11 | 11 | ||||||||||
| VP/Directors | 22 | 6 | 28 | |||||||||
| Managers | 9 | 15 | 24 | |||||||||
| Scientists & Support functions | 47 | 56 | 103 | |||||||||
| Total Employees | 89 | 77 | 166 |
Autolus Therapeutics Limited re-registered as a public limited company and was renamed Autolus Therapeutics plc.
Principal Risks and Uncertainties
An investment in our ADSs involves a high degree of risk. You should carefully consider the risks described below, and all other information appearing
elsewhere in this Annual Report, including our consolidated financial statements and the related notes hereto, before making an investment decision regarding our securities. The occurrence of any of the events or developments described below could
harm our business, financial condition, results of operations and growth prospects.
Risks Related to Our Financial Position and Need for Capital
We have incurred significant losses in every year since our inception. We expect to continue to incur losses over the next several years and may
never achieve or maintain profitability.
We are a clinical-stage biopharmaceutical company with a limited operating history and we have incurred
significant net losses since our inception in 2014. We have incurred losses of 31.1 million and 15.6 million for the years ended September 30, 2018 and 2017 respectively. As of September 30, 2018, we had an accumulated
deficit of 58.3 million. We have funded our operations to date primarily with proceeds from the sale of our equity securities.