6-K
Autolus Therapeutics plc (AUTL)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of November 2021
Commission File Number: 001-38547
Autolus Therapeutics plc
(Translation of registrant’s name into English)
The MediaWorks
191 Wood Lane
London W12 7FP
United Kingdom
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
x Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
The Company’s Unaudited Condensed Consolidated Interim Financial Statements for the Three and Nine Months Ended September 30, 2021, included as Exhibit 99.1 of this Report on Form 6-K (the “Report”) and the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three and Nine Months Ended September 30, 2021, included as Exhibit 99.2 of this Report shall be deemed to be incorporated by reference into the registration statements on Form S-8 (File No. 333-226457), Form F-3 (File No. 333-232690) and Form F-3 (File No. 333-258556) of Autolus Therapeutics plc (the "Company") and to be a part thereof from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently furnished.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
This Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this Report. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those expressed or implied by these forward-looking statements. For a discussion of risk factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this Report, you should refer to the Company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing the Company’s views as of any date subsequent to the date of this Report.
EXHIBIT INDEX
| Exhibit<br>No. | Description |
|---|---|
| 99.1 | Unaudited Condensed Consolidated Interim Financial Statements for the Three and Nine Months Ended September 30, 2021 |
| 99.2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three and Nine Months Ended September 30, 2021 |
| 101 | The following materials from this Report on Form 6-K are formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months ended September 30, 2021 and 2020 (Unaudited), (ii) Condensed Consolidated Balance Sheets as at September 30, 2021 and December 31, 2020 (Unaudited), (iii) Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three and Nine Months ended September 30, 2021 and 2020 (Unaudited), (iv) Condensed Consolidated Statements of Cash Flows for the Nine Months ended September 30, 2021 and 2020 (Unaudited), and (v) Notes to Condensed Consolidated Financial Statements (Unaudited). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Autolus Therapeutics plc | ||||
|---|---|---|---|---|
| Date: | November 3, 2021 | By: | /s/ Christian Itin | |
| Name | Christian Itin, Ph.D. | |||
| Title: | Chief Executive Officer |
autl-20210930
Exhibit 99.1
INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
| Condensed Consolidated Balance Sheets as ofSeptember30, 2021 and December 31, 2020 (Unaudited) | 2 |
|---|---|
| Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited) | 3 |
| Condensed Consolidated Statements of Shareholders’ Equity for the Three andNineMonths EndedSeptember30, 2021 and 2020 (Unaudited) | 4 |
| Condensed Consolidated Statements of Cash Flows for theNineMonths EndedSeptember30, 2021 and 2020 (Unaudited) | 6 |
| Notes to Condensed Consolidated Financial Statements (Unaudited) | 7 |
AUTOLUS THERAPEUTICS PLC
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
| September 30, 2021 | December 31, 2020 | |||
|---|---|---|---|---|
| Assets | ||||
| Current assets: | ||||
| Cash | $ | 173,060 | $ | 153,299 |
| Restricted cash | 210 | 786 | ||
| Prepaid expenses and other assets, current | 64,407 | 42,899 | ||
| Total current assets | 237,677 | 196,984 | ||
| Non-current assets: | ||||
| Property and equipment, net | 33,962 | 38,046 | ||
| Right of use assets, net | 19,196 | 51,637 | ||
| Long-term deposits | 1,796 | 2,625 | ||
| Prepaid expenses and other assets, non-current | 2,512 | 3,033 | ||
| Deferred tax asset | 1,406 | 1,754 | ||
| Intangible assets, net | 87 | 158 | ||
| Total assets | $ | 296,636 | $ | 294,237 |
| Liabilities and shareholders' equity | ||||
| Current liabilities: | ||||
| Accounts payable | 1,462 | 2,263 | ||
| Accrued expenses and other liabilities | 28,634 | 27,781 | ||
| Lease liabilities | 4,467 | 3,590 | ||
| Total current liabilities | 34,563 | 33,634 | ||
| Non-current liabilities: | ||||
| Lease liabilities | 17,343 | 50,571 | ||
| Total liabilities | 51,906 | 84,205 | ||
| Shareholders' equity: | ||||
| Ordinary shares, $0.000042 par value; 200,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 72,918,994 and 52,346,231, shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 3 | 3 | ||
| Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020 | — | — | ||
| Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020 | 118 | 118 | ||
| Deferred C shares, £0.000008 par value; 1 share authorized, issued and outstanding at September 30, 2021 and December 31, 2020 | — | — | ||
| Additional paid-in capital | 733,792 | 595,016 | ||
| Accumulated other comprehensive loss | (9,509) | (5,861) | ||
| Accumulated deficit | (479,674) | (379,244) | ||
| Total shareholders' equity | 244,730 | 210,032 | ||
| Total liabilities and shareholders' equity | $ | 296,636 | $ | 294,237 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
AUTOLUS THERAPEUTICS PLC
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||
| Grant income | $ | 236 | $ | 438 | $ | 643 | $ | 1,069 |
| License revenue | — | 242 | 1,507 | 242 | ||||
| Operating expenses: | ||||||||
| Research and development | (32,292) | (33,545) | (95,154) | (96,160) | ||||
| General and administrative | (8,299) | (9,843) | (24,274) | (25,966) | ||||
| Loss on disposal of leasehold improvements | — | — | (672) | — | ||||
| Total operating expenses, net | (40,355) | (42,708) | (117,950) | (120,815) | ||||
| Other income (expense): | ||||||||
| Interest income | 28 | 37 | 113 | 500 | ||||
| Other income (expense) | 951 | (2,509) | (59) | 2,500 | ||||
| Total other income (expense), net | 979 | (2,472) | 54 | 3,000 | ||||
| Net loss before income tax | (39,376) | (45,180) | (117,896) | (117,815) | ||||
| Income tax benefit | 5,385 | 7,865 | 17,466 | 18,582 | ||||
| Net loss attributable to ordinary shareholders | (33,991) | (37,315) | (100,430) | (99,233) | ||||
| Other comprehensive (loss) income: | ||||||||
| Foreign currency exchange translation adjustment | (6,463) | 10,915 | (3,648) | (8,605) | ||||
| Total comprehensive loss | (40,454) | (26,400) | (104,078) | (107,838) | ||||
| Basic and diluted net loss per ordinary share | $ | (0.47) | $ | (0.72) | $ | (1.46) | $ | (1.93) |
| Weighted-average basic and diluted ordinary shares | 72,896,362 | 52,093,826 | 68,770,962 | 51,339,662 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
AUTOLUS THERAPEUTICS PLC
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited)
(In thousands, except share amounts)
| Three Months Ended September 30, 2021 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ordinary Shares | Deferred Shares | Deferred B Shares | Deferred C Shares | |||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid in Capital | Accumulated other comprehensive loss | Accumulated deficit | Total | |||||||||
| Balance at June 30, 2021 | 72,742,582 | $ | 3 | 34,425 | $ | — | 88,893,548 | $ | 118 | 1 | $ | — | $ | 732,290 | $ | (3,046) | $ | (445,683) | $ | 283,682 |
| Share-based compensation expense | — | — | — | — | — | — | — | — | 1,502 | — | — | 1,502 | ||||||||
| Vesting of restricted stock | 141,875 | — | — | — | — | — | — | — | — | — | — | — | ||||||||
| Exercise of share options | 34,537 | — | — | — | — | — | — | — | — | — | — | — | ||||||||
| Unrealized loss on foreign currency translation | — | — | — | — | — | — | — | — | — | (6,463) | — | (6,463) | ||||||||
| Net loss | — | — | — | — | — | — | — | — | — | — | (33,991) | (33,991) | ||||||||
| Balance at September 30, 2021 | 72,918,994 | $ | 3 | 34,425 | $ | — | 88,893,548 | $ | 118 | 1 | $ | — | $ | 733,792 | $ | (9,509) | $ | (479,674) | $ | 244,730 |
| Three Months Ended September 30, 2020 | ||||||||||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ordinary Shares | Deferred Shares | Deferred B Shares | Deferred C Shares | |||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid in Capital | Accumulated other comprehensive loss | Accumulated deficit | Total | |||||||||
| Balance at June 30, 2020 | 52,250,404 | $ | 3 | 34,425 | $ | — | 88,893,548 | $ | 118 | 1 | $ | — | $ | 586,110 | $ | (28,211) | $ | (299,068) | $ | 258,952 |
| Share-based compensation expense | — | — | — | — | — | — | — | — | 4,245 | — | — | 4,245 | ||||||||
| Exercise of share options | 48,472 | — | — | — | — | — | — | — | 14 | — | — | 14 | ||||||||
| Unrealized gain on foreign currency translation | — | — | — | — | — | — | — | — | — | 10,915 | — | 10,915 | ||||||||
| Net loss | — | — | — | — | — | — | — | — | — | — | (37,315) | (37,315) | ||||||||
| Balance at September 30, 2020 | 52,298,876 | $ | 3 | 34,425 | $ | — | 88,893,548 | $ | 118 | 1 | $ | — | $ | 590,369 | $ | (17,296) | $ | (336,383) | $ | 236,811 |
The accompanying notes are an integral part of these condensed consolidated financial statements
AUTOLUS THERAPEUTICS PLC
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited)
(In thousands, except share amounts)
| Nine Months Ended September 30, 2021 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ordinary Shares | Deferred Shares | Deferred B Shares | Deferred C Shares | |||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid in Capital | Accumulated other comprehensive loss | Accumulated deficit | Total | |||||||||
| Balance at December 31, 2020 | 52,346,231 | $ | 3 | 34,425 | $ | — | 88,893,548 | $ | 118 | 1 | $ | — | $ | 595,016 | $ | (5,861) | $ | (379,244) | $ | 210,032 |
| Issuance of ordinary shares, net of issuance costs | 20,216,544 | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | 136,538 | $ | — | $ | — | $ | 136,538 |
| Share-based compensation expense | — | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | 2,112 | $ | — | $ | — | $ | 2,112 |
| Vesting of restricted stock | 163,375 | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | — | $ | — | $ | — | $ | — |
| Exercise of share options | 192,844 | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | 126 | $ | — | $ | — | $ | 126 |
| Unrealized loss on foreign currency translation | — | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | — | $ | (3,648) | $ | — | $ | (3,648) |
| Net loss | — | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | — | $ | — | $ | (100,430) | $ | (100,430) |
| Balance at September 30, 2021 | 72,918,994 | $ | 3 | 34,425 | $ | — | 88,893,548 | $ | 118 | 1 | $ | — | $ | 733,792 | $ | (9,509) | $ | (479,674) | $ | 244,730 |
| Nine Months Ended September 30, 2020 | ||||||||||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ordinary Shares | Deferred Shares | Deferred B Shares | Deferred C Shares | |||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid in Capital | Accumulated other comprehensive loss | Accumulated deficit | Total | |||||||||
| Balance at December 31, 2019 | 44,983,006 | $ | 2 | 34,425 | $ | — | 88,893,548 | $ | 118 | 1 | $ | — | $ | 500,560 | $ | (8,691) | $ | (237,150) | $ | 254,839 |
| Issuance of ordinary shares, net of issuance costs | 7,250,000 | $ | 1 | — | $ | — | — | $ | — | — | $ | — | $ | 73,952 | $ | — | $ | — | $ | 73,953 |
| Share-based compensation expense | — | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | 15,786 | $ | — | $ | — | $ | 15,786 |
| Restricted shares - forfeited | (1,969) | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | — | $ | — | $ | — | $ | — |
| Exercise of share options | 67,839 | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | 71 | $ | — | $ | — | $ | 71 |
| Unrealized loss on foreign currency translation | — | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | — | $ | (8,605) | $ | — | $ | (8,605) |
| Net loss | — | $ | — | — | $ | — | — | $ | — | — | $ | — | $ | — | $ | — | $ | (99,233) | $ | (99,233) |
| Balance at September 30, 2020 | 52,298,876 | $ | 3 | 34,425 | $ | — | 88,893,548 | $ | 118 | 1 | $ | — | $ | 590,369 | $ | (17,296) | $ | (336,383) | $ | 236,811 |
The accompanying notes are an integral part of these condensed consolidated financial statements
AUTOLUS THERAPEUTICS PLC
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In thousands)
| Nine Months Ended September 30, | ||||
|---|---|---|---|---|
| 2021 | 2020 | |||
| Cash flows from operating activities: | ||||
| Net loss | $ | (100,430) | $ | (99,233) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||
| Depreciation and amortization | 6,354 | 3,996 | ||
| Share-based compensation (net of amount capitalized) | 2,112 | 15,873 | ||
| Gain on lease incentive and modification | — | (1,335) | ||
| Loss (gain) on termination of operating lease | 12 | (160) | ||
| Loss on disposal of property and equipment | 672 | — | ||
| Deferred income tax | 348 | — | ||
| Changes in operating assets and liabilities | ||||
| Prepaid expenses and other assets, current | (22,749) | (12,711) | ||
| Prepaid expenses and other assets, non-current | 355 | (2,650) | ||
| Long-term deposits | 811 | (455) | ||
| Right of use assets, net | 2,824 | 2,593 | ||
| Accounts payable | (783) | 510 | ||
| Accrued expenses and other liabilities | 2,883 | 4,951 | ||
| Lease liabilities | (1,112) | (1,407) | ||
| Net cash used in operating activities | (108,703) | (90,028) | ||
| Cash flows from investing activities: | ||||
| Purchases of property and equipment | (7,272) | (9,209) | ||
| Net cash used in investing activities | (7,272) | (9,209) | ||
| Cash flows from financing activities: | ||||
| Proceeds of issuance of ordinary shares, net of issuance costs | 136,522 | 73,952 | ||
| Proceeds from the exercise of stock options | 126 | 71 | ||
| Net cash provided by financing activities | 136,648 | 74,023 | ||
| Effect of exchange rate changes on cash and restricted cash | (1,488) | (7,735) | ||
| Net increase (decrease) in cash and restricted cash | 19,185 | (32,949) | ||
| Cash and restricted cash, beginning of period | 154,085 | 211,430 | ||
| Cash and restricted cash, end of period | $ | 173,270 | $ | 178,481 |
| Supplemental non-cash flow information | ||||
| Property and equipment purchases included in accounts payable and accrued expenses | $ | 1,004 | $ | 2,872 |
| Right of use assets terminated and obtained in exchange for operating lease liabilities, net | $ | 28,517 | $ | 29,062 |
| Capitalized implementation costs included in accrued expenses | $ | 11 | $ | 144 |
| Capitalized share-based compensation | $ | — | $ | (87) |
| Reconciliation of cash and restricted cash reported within the condensed consolidated balance sheets: | ||||
| Cash | $ | 173,060 | $ | 177,695 |
| Restricted cash | 210 | 786 | ||
| Total cash and restricted cash | $ | 173,270 | $ | 178,481 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited)
Note 1. Nature of the Business
Autolus Therapeutics plc (the “Company”) is a biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer. Using its broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and attack and kill these cells. The Company believes its 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.
The Company is a public limited company incorporated in England and Wales. On June 22, 2018, the Company completed its initial public offering ("IPO") of American Depositary Shares (“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 $156.5 million, after deducting underwriting discounts and commissions and offering expenses paid by the Company.
On April 15, 2019, the Company completed an underwritten public offering of 4,830,000 ADSs representing 4,830,000 ordinary shares, at a public offering price of $24.00 per ADS, which includes an additional 630,000 ADSs issued upon the exercise in full of the underwriters’ option to purchase additional ADSs. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $108.8 million.
On January 27, 2020, the Company completed an underwritten public offering of 7,250,000 ADSs representing 7,250,000 ordinary shares, at a public offering price of $11.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $74.0 million.
In January 2021, the Company sold an aggregate of 1,718,506 ADSs under its Open Market Sale Agreement ("Sales Agreement") with Jefferies LLC as sales agent. Aggregate net proceeds to the Company, after commission fees and offering expenses, were $15.3 million.
On February 12, 2021, the Company completed an underwritten public offering of 14,285,715 ADSs, which includes the full exercise by the underwriters to purchase an additional 2,142,857 ADSs, at a public offering price of $7.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $106.9 million.
On June 17, 2021 the Company sold an aggregate of 2,069,466 ADSs under its Sales Agreement with Jefferies LLC as sales agent. Aggregate net proceeds to the Company after commission fees and offering expenses, were $14.3 million.
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 commercialization. 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 realize 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 $34.0 million and $37.3 million for the three months ended September 30, 2021, and 2020, respectively, and $100.4 million and $99.2 million for the nine months ended September 30, 2021 and 2020, respectively.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
In addition, the Company had an accumulated deficit of $479.7 million and $379.2 million as of September 30, 2021, and December 31, 2020, respectively. The Company expects to continue to generate operating losses for the foreseeable future. The future viability of the Company 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, 2021 of $173.1 million, when combined with the $25.0 million of additional cash which we received in October 2021 from our 2020 UK research and development tax credit, will be sufficient to fund the Company’s operations for at least twelve months from the issuance of these financial statements.
Impact of COVID-19 Pandemic
In response to the ongoing coronavirus 2019, or COVID-19, pandemic, the Company established a cross-functional task force and have implemented business continuity plans designed to address and mitigate its impact on the Company's employees and business. While the Company has 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 its business, financial condition, results of operations and growth prospects to be materially adversely affected.
The Company implemented a COVID-19 surveillance testing program available to Company staff who work on-site at the Company’s U.K. facility to minimize the spread of COVID-19 within the Company. The Company continues to track COVID-19 developments in Europe and the United States closely for their potential impact on the Company’s clinical trial sites, logistics and supply chain to ensure it can continue to maintain clinical trial conduct and data integrity. As the patients in the Company’s clinical trials are severely immune suppressed as a consequence of their underlying disease and the treatment they receive in the trials, the Company is also monitoring other transmissible infectious diseases, including influenza.
The Company is not aware of any specific event or circumstance that has impacted on its operations in a manner which would require the Company to update its estimates, judgments or revise the carrying value of its assets or liabilities during the nine months ended September 30, 2021. However, these estimates may change, as new events occur and additional information is obtained, relating to the COVID-19 pandemic or otherwise. Changes in estimates would be recognized in the consolidated financial statements as soon as they become known.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include those of the Company and its wholly-owned subsidiaries, Autolus Limited, Autolus Inc. and Autolus GmbH, and have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany accounts and transactions have been eliminated upon consolidation.
In the opinion of management, all adjustments considered necessary to present fairly the results of the interim periods have been included and consist only of normal and recurring adjustments. Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. As such, the information included in these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2020, included in our Annual Report on Form 20-F.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation and income taxes. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ materially from those estimates.
Cash and Cash Equivalents
The Company considers cash and cash equivalents in the unaudited condensed consolidated financial statements to include cash at banks with a maturity of less than three months, which is subject to an insignificant risk of changes in value.
Restricted Cash
The Company entered into a credit card arrangement that requires a security deposit of $0.2 million. The restricted cash of $0.6 million previously held for a letter of credit in connection with a lease was released following the termination of the Company’s facility lease, in April 2021, and the $0.6 million was reclassified to cash and cash equivalents. The Company includes the remaining restricted cash balance of $0.2 million in cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the Company's condensed consolidated statements of cash flows.
Fair Value Measurements
The carrying amounts reported in the balance sheets for cash and restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments.
Concentration of Credit Risk
Financial instruments that subject the Company to credit risk consist primarily of cash and restricted cash. The Company places cash and restricted cash in established financial institutions. The Company has no significant off-balance-sheet risk or concentration of credit risk, such as foreign exchange contracts, options contracts, or other foreign hedging arrangements.
Property and Equipment
Property and equipment are recorded at cost and depreciated or amortized using the straight-line method over the estimated useful lives of the respective assets. As of September 30, 2021 and December 31, 2020, the Company’s property and equipment consisted of office equipment, lab equipment, furniture and fixtures, and leasehold improvements. The office equipment has an estimated useful life of three years, lab equipment has an estimated useful life of five or ten years, and furniture and fixtures have an estimated useful life of five years. Leasehold improvements are depreciated over the shorter of the lease term or the estimated useful life of the asset. Assets under construction primarily consist of costs incurred with leasehold improvements, and, once placed into service, will be depreciated over the shorter of the lease term or the estimated useful life of the asset. Upon retirement or sale, the cost of assets are disposed of, and the related accumulated depreciation, is removed from the accounts and any resulting gain or loss is included in the statement of operations and other comprehensive loss. Repairs and maintenance expenditures, which are not considered improvements and do not extend the useful life of property and equipment, are expensed as incurred.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The Company did not recognize a disposal loss in the three months ended September 30, 2021 and recognized a disposal loss of $0.7 million in the nine months ended September 30, 2021 for leasehold improvements which are no longer being utilized in the facility in White City, London. The Company did not recognize a disposal loss in the three and nine months ended September 30, 2020.
The Company evaluates an asset for potential impairment when events or changes in circumstances indicate the carrying value of the asset may not be recoverable. Recoverability is measured by comparing the book value of the asset to the expected future net undiscounted cash flows that the asset is expected to generate. If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the asset exceeds the fair value. The Company did not recognize an impairment in the three and nine months ended September 30, 2021 and 2020.
Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. However, certain adjustments to the right-of-use asset may be required for items such as incentives received, initial direct costs, or prepayments. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
In accordance with the guidance in ASC 842, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.). Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. The Company accounts for the lease and non-lease components of leases for classes of all underlying assets and allocates all of the contract consideration to the lease component.
Intangible Assets Subject to Amortization
The Company’s intangible assets are related to acquired software licenses with finite lives and are amortized over their useful lives and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If any indicators of impairment are present, the Company tests for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. The Company evaluates the useful lives for these intangible assets each reporting period to determine whether events and circumstances warrant a revision in their remaining useful lives. The Company did not recognize an impairment loss in the three and nine months ended September 30, 2021 and 2020.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker in deciding how to allocate resources and assess performance. The Company and its chief operating decision maker, the Company’s Chief Executive Officer, view the Company’s operations and manage its business as a single operating segment, which is the business of developing and commercializing gene therapies; however, the Company operates in three geographic regions: the United Kingdom, the United States, and Germany. Substantially all of the Company’s assets are held in the United Kingdom.
Research and Development Costs
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries, share-based compensation and benefits, depreciation expense, third-party license fees, external costs of outside vendors engaged to conduct clinical development activities, clinical trials, costs to manufacture clinical trial materials and certain tax credits associated with research and development activities. The Company recorded the U.K. research and development expenditure credit (“RDEC”) in the amount of $7,000 and $59,000 for the three months ended September 30, 2021 and 2020, respectively, and $94,000 and $126,000 for the nine months ended September 30, 2021 and 2020, respectively, as reductions of research and development expenses within the Company’s statement of operations and comprehensive loss.
Accrued Research and Development Expenses
As part of the process of preparing its unaudited condensed consolidated financial statements, the Company is required to estimate accruals for research and development expenses. This process involves reviewing and identifying services which have been performed by third parties on the Company’s behalf and determining the value of these services. In addition, the Company makes estimates of costs incurred to date but not yet invoiced, in relation to external clinical research organizations and clinical site costs. The Company analyzes the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs, when evaluating the adequacy of the accrued liabilities for research and development. The Company makes judgments and estimates in determining the accrued balance in any accounting period.
Share-Based Compensation
The Company recognizes compensation expense for equity awards based on the grant date fair value of the award. The Company recognizes share-based compensation expense for awards granted to employees that have a graded vesting schedule based on a service condition only on a straight-line basis over the requisite service period for each separately vesting portion of the award as if the award was, in substance, multiple awards (the “graded-vesting attribution method”), based on the estimated grant date fair value for each separately vesting tranche. For equity awards with a graded vesting schedule and a combination of service and performance conditions, the Company recognizes share-based compensation expense using a graded-vesting attribution method over the requisite service period when the achievement of a performance-based milestone is probable, based on the relative satisfaction of the performance condition as of the reporting date.
For share-based awards granted to consultants and non-employees, compensation expense is recognized using the graded-vesting attribution method over the period during which services are rendered by such consultants and non-employees until completed. The measurement date for employee awards is the date of grant, and share-based compensation costs are recognized as expense over the employees’ requisite service period, which is the vesting period, on an accelerated basis.
The Company accounts for forfeitures as they occur.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option pricing model. See Note 7 for the Company’s assumptions used in connection with share option grants made during the periods covered by these unaudited condensed consolidated financial statements. Assumptions used in the option pricing model include the following:
Expected volatility. The Company lacks company-specific historical and implied volatility information for the Company's ADSs for expected terms greater than three years. Therefore, it uses a combination of the historical volatility of the ADSs and also the expected share volatility based on the historical volatility of publicly traded peer companies and expect to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded ADS price.
Expected term. The expected term of the Company’s share options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.
Risk-free interest rate. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods that are approximately equal to the expected term of the award.
Expected dividend. Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on ordinary shares and does not expect to pay any cash dividends in the foreseeable future.
Fair value of ordinary shares. The fair market value of the Company’s ADSs underlying the share option is equal to the closing price of the ADSs on the Nasdaq Global Select Market on the date the grant is approved by the board of directors.
Foreign Currency Remeasurement and Translation
The Company maintains its unaudited condensed consolidated financial statements in its functional currency, which is the pound sterling. Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net loss for the respective periods. The Company recorded a foreign exchange gain of $1.0 million and foreign exchange loss of $3.8 million for the three months ended September 30, 2021 and 2020, respectively. The Company recorded a foreign exchange loss of $2.2 million and a foreign exchange gain $1.0 million for the nine months ended September 30, 2021 and 2020, respectively. Foreign exchange gains and losses are included in other income in the statements of operations and comprehensive loss.
For financial reporting purposes, the unaudited condensed consolidated financial statements of the Company have been translated into U.S. dollars. Assets and liabilities have been translated at the exchange rates at the balance sheet dates, while revenue and expenses are translated at the average exchange rates over the reporting period and shareholders’ equity amounts are translated based on historical exchange rates as of the date of each transaction. Translation adjustments are not included in determining the Company's net loss but are included in foreign exchange adjustment to other comprehensive loss, a component of shareholders’ equity.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Patent Costs
The Company expenses patent prosecution and related legal costs as they are incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss. The Company recorded patent expenses of $0.3 million and $0.4 million for the three months ended September 30, 2021 and 2020, respectively, and $1.4 million and $1.6 million for the nine months ended September 30, 2021 and 2020, respectively.
Grant Income
The Company has received research grants under which it is reimbursed for specific research and development activities. Payments received are recognized as income in the statements of operations and comprehensive loss over the period in which the Company recognizes the related costs. At the time the Company recognizes grant income, it has complied with the conditions attached to it and the receipt of the reimbursement is reasonably assured. The Company has received grants from the U.K. government, which are repayable under certain circumstances, including breach or noncompliance. For grants with refund provisions, the Company reviews the grant to determine the likelihood of repayment. If the likelihood of repayment of the grant is determined to be remote, then the grant is recognized as grant income. The Company has determined that the likelihood of any repayment events included in its current grants is remote.
License Revenue
The Company accounts for its revenues pursuant to the provisions of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”).
The Company has no products approved for commercial sale and have not generated any revenue from commercial product sales. The total revenue to date has been generated principally from license agreements with the Company's two customers. The terms of an agreement which was entered into during the three months ended June 30, 2021, included a non-refundable upfront license fee, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on product sales. The Company did not record any license revenue for three months ended September 30, 2021 and recorded $0.2 million of license revenue for the three months ended September 30, 2020. The Company recognized $1.5 million and $0.2 million of license revenue for the nine months ended September 30, 2021, and September 30, 2020, respectively.
In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
License Fees and Multiple Element Arrangements
If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license at such time as the license is transferred to the licensee and the licensee is able to use, and benefit from, the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligations to determine whether the combined performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, the Company considers the nature of service that the Company promises to transfer to the customer. When the Company decides on a method of measurement, the Company will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances.
Customer Options
If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options that are not determined to be material rights are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. We evaluate the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. We allocate the transaction price to material rights based on the relative standalone selling price, which is determined based on any identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised. During the three and nine months ended September 30, 2021 and September 30, 2020 the company did not recognize any revenue related to customer options.
Contingent Research Milestone Payments
ASC Topic 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example.
If the consideration in a contract includes a variable amount, the Company will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if the Company’s entitlement to the consideration is contingent on the occurrence or non-occurrence of a future event. The Company considers contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period.
The Company assesses whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestone revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant.
GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinate. The Company considers all relevant factors.
For three and nine months ended September 30, 2021 and September 30, 2020, the Company has not recognized any variable consideration with regards to the development milestones, which are included in the license agreements that were executed in the current and prior periods. This is due to the fact that those development milestones have not yet been met and the recognition of the related revenue is not yet probable.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Royalty Revenue
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
For three and nine months ended September 30, 2021 and September 30, 2020, the Company has not recognized any royalty revenue from in the license agreements that were executed in the current and prior periods. This is due to the fact that there are no related sales for the technology which was licensed in the agreements.
Income Taxes
The Company accounts for income taxes under the asset and liability method which includes the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s unaudited condensed consolidated financial statements. Under this approach, deferred taxes are recorded for the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. The provision (benefit) for income taxes represents income taxes paid or payable (or a reduction of such amounts) for the current year plus deferred taxes. Deferred taxes result from differences between the unaudited condensed consolidated financial statements and tax bases of the Company’s assets and liabilities, and are adjusted for changes in tax rates and tax law when changes are enacted. The effects of future changes in income tax laws or rates are not anticipated.
The Company is subject to income taxes in the United Kingdom and the United States. The calculation of the Company’s tax provision involves the application of United Kingdom and United States tax law and requires judgment and estimates.
The Company evaluates the realizability of its deferred tax assets at each reporting date, and establishes a valuation allowance when it is more likely than not that all or a portion of its deferred tax assets will not be realized.
The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income of the same character and in the same jurisdiction. The Company considers all available positive and negative evidence in making this assessment, including, but not limited to, the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. In circumstances where there is sufficient negative evidence indicating that the Company’s deferred tax assets are not more likely than not realizable, the Company establishes a valuation allowance.
The Company uses a two-step approach for recognizing and measuring uncertain tax positions. The first step is to evaluate tax positions taken or expected to be taken in a tax return by assessing whether they are more likely than not sustainable, based solely on their technical merits, upon examination, and including resolution of any related appeals or litigation process. The second step is to measure the associated tax benefit of each position as the largest amount that the Company believes is more likely than not realizable. Differences between the amount of tax benefits taken or expected to be taken in the Company’s income tax returns and the amount of tax benefits recognized in the its unaudited condensed consolidated financial statements represent the Company’s unrecognized income tax benefits, which it either records as a liability or reduction of deferred tax assets.
Income Tax Credit
The Company benefits from the U.K. research and development tax credit regime under both the small and medium sized enterprise, or SME, scheme and by claiming an RDEC in respect of grant funded projects. Under the SME regime, a portion of the Company’s losses can be surrendered for a cash rebate of up to 33.35% of eligible expenditures. SME credits are accounted for within the tax provision in the year in which the expenditures were incurred. RDEC credits are accounted for within other income in the unaudited condensed consolidated statements of operations and comprehensive loss.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Comprehensive Loss
The Company follows the provisions of the Financial Accounting Standards Board (“FASB”) ASC Topic 220, Comprehensive Income, which establishes standards for the reporting and display of comprehensive income and its components. Comprehensive loss is defined to include all changes in equity during a period except those resulting from investments by owners and distributions to owners. The Company recorded a loss of $6.5 million and a gain of $10.9 million related to foreign currency translation adjustments during the three months ended September 30, 2021 and 2020, respectively. The Company recorded losses of $3.6 million and $8.6 million related to foreign currency translation adjustments during the nine months ended September 30, 2021 and 2020, respectively.
Net Loss Per Share
Basic and diluted net loss per ordinary share is determined by dividing net loss by the weighted average number of ordinary shares outstanding during the period. For all periods presented, outstanding but unvested restricted shares and share options have been excluded from the calculation, because their effects would be anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per share are the same for all periods presented.
The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
| As of September 30, | ||
|---|---|---|
| 2021 | 2020 | |
| Unvested restricted incentive shares and units | 1,105,300 | 589,276 |
| Share options | 6,343,281 | 5,749,844 |
| Total | 7,448,581 | 6,339,120 |
Recent Accounting Pronouncements Not Yet Adopted
Accounting standards that have been issued by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company's financial statements upon adoption.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 3. Prepaid Expenses and Other Assets, Current
Prepaid expenses and other assets, current consisted of the following (in thousands):
| September 30, 2021 | December 31, 2020 | |||
|---|---|---|---|---|
| Research and development claims receivable | $ | 41,517 | $ | 24,711 |
| Prepayments | 8,251 | 10,206 | ||
| VAT receivable | 1,309 | 3,124 | ||
| Lease receivables from terminations | — | 1,237 | ||
| Other asset | 545 | — | ||
| Lease deposits receivable | 544 | — | ||
| Grant income receivable | 281 | 414 | ||
| Other receivable | 10,660 | 199 | ||
| Deferred cost | 1,300 | 3,008 | ||
| Total prepaid expenses and other current assets | $ | 64,407 | $ | 42,899 |
The increase in research and development claims receivable as at September 30, 2021 compared to December 31, 2020 is due to the increase in the receivable for the current year tax provision as well as the UK research and development tax credit for the financial year ended December 31, 2020, The 2020 tax credit was still receivable as at September 30, 2021, but was subsequently received in October 2021. More information on the movement in the tax position between periods can be found in Note 9.
The decrease in prepayments of $2.0 million as at September 30, 2021 when compared to December 31, 2020 is primarily related to decreases in prepayments for clinical trials and lower payments of directors' and officers' liability insurance due to the timing of payments.
The increase in other receivables of $10.5 million as at September 30, 2021 when compared to December 31, 2020 is primarily due to a combination of $8.4 million in reimbursable amounts related to costs associated with design of the Company's manufacturing facility in Stevenage, United Kingdom and a non-refundable upfront license fee of $1.5 million arising from a license agreement entered into by the Company during the three months ended June 30, 2021. The non-refundable upfront license fee of $1.5 million was received during October 2021.
The decrease in deferred costs of $1.7 million as at September 30, 2021 when compared to December 31, 2020 is primarily in respect to a decrease of deferred costs incurred relating to manufacturing contracts with contract manufacturing organizations.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 4. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
| September 30, 2021 | December 31, 2020 | |||
|---|---|---|---|---|
| Lab equipment | $ | 33,073 | $ | 23,491 |
| Office equipment | 3,144 | 2,928 | ||
| Furniture and fixtures | 1,318 | 1,340 | ||
| Leasehold improvements | 14,837 | 10,629 | ||
| Assets under construction | 2,139 | 14,321 | ||
| Less: accumulated depreciation | (20,549) | (14,663) | ||
| Total property and equipment, net | $ | 33,962 | $ | 38,046 |
The increase in lab equipment of $9.6 million relates primarily to lab equipment used to expand and enhance the Company's manufacturing capabilities.
The increase in leasehold improvements of $4.2 million primarily relates to both outfitting of the Company's corporate headquarters with additional laboratory space, as well as improvements to the scaling of manufacturing at the Company's Catapult facility.
Depreciation expense for the three months ended September 30, 2021 and 2020 was $2.4 million and $1.5 million, respectively, and for the nine months ended September 30, 2021 and 2020, was $6.5 million and $4.0 million, respectively.
Note 5. Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted of the following (in thousands):
| September 30, 2021 | December 31, 2020 | |||
|---|---|---|---|---|
| Compensation and benefits | $ | 8,798 | $ | 8,732 |
| Research and development costs | 16,457 | 15,343 | ||
| UCLB milestone and option | — | 205 | ||
| Professional fees | 3,060 | 3,005 | ||
| U.S. corporate income and local taxes | 7 | — | ||
| Other liabilities | 312 | 496 | ||
| Total accrued expenses and other liabilities | $ | 28,634 | $ | 27,781 |
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 6. Shareholders’ Equity
Ordinary Shares
Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the board of directors and declared by the shareholders. As of September 30, 2021, the Company has not declared any dividends.
Effective from June 26, 2018, the board of directors has the authority to allot new ordinary shares or to grant rights to subscribe for or to convert any security into ordinary shares in the Company up to a maximum aggregate nominal amount of $8,400. This authority runs for five years and will expire on June 26, 2023.
Effective from June 26, 2018, the board of directors also has the authority to allot ordinary shares for cash or to grant rights to subscribe for or to convert any security into ordinary shares in the Company without first offering them to existing shareholders in proportion to their existing holdings up to an aggregate maximum nominal amount of $8,400. This authority runs for five years and will expire on June 26, 2023.
As of September 30, 2021 the Company’s issued capital share consisted of 72,918,994 ordinary shares, with a nominal value of $0.000042 per share, (ii) 34,425 deferred shares, with a nominal value of £0.00001 per share, (iii) 88,893,548 B deferred shares, with a nominal value of £0.00099 per share and (iv) 1 C deferred share, with a nominal value of £0.000008. Each issued share has been fully paid.
Open Market Sale Agreement
In September 2020, the Company entered into a Sale Agreement ("Sales Agreement") with Jefferies LLC (Jefferies), under which the Company may, at its option, offer and sell ADSs having an aggregate offering price of up to $100 million from time to time through Jefferies, acting as sales agent. Any such sales made through Jefferies can be made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act, or in other transactions pursuant to an effective shelf registration statement on Form F-3. The Company agreed to pay Jefferies a commission of 3.0% of the gross proceeds of any sales of ADSs sold pursuant to the Sales Agreement. During the three months ended September 30, 2021, the Company did not issue any ADSs under the Sales Agreement. During the nine months ended September 30, 2021, the Company issued an aggregate of 3,787,972 ADSs under the Sales Agreement for net proceeds, after underwriting discounts and offering expenses of $29.6 million.
Note 7. Share-Based Compensation
Options granted under the Company's 2018 Equity Incentive Plan (the "2018 Plan") and 2017 Stock Option Plan (the "2017 Plan"), as well as restricted shares granted as employee incentives, typically vest over a four-year service period with 25% of the award vesting on the first anniversary of the commencement date and the balance vesting monthly over the remaining three years, unless the award contains specific performance vesting provisions. For equity awards issued that have both a performance vesting condition and a services condition, once the performance criteria is achieved, the awards are then subject to a four-year service vesting with 25% of the award vesting on the first anniversary of the performance condition being achieved and the balance vesting monthly over the remaining three years. Options granted in January 2021 contained performance conditions related to specified clinical milestones. Options granted under the 2018 Plan and 2017 Plan generally expire 10 years from the date of grant. For certain senior members of management and directors, the board of directors has approved an alternative vesting schedule. Restricted stock units awarded in December 2019 vest over a three-year service period with 50% of the award vesting one and a half years, or 18 months, from commencement date and the remaining 50% of the award vesting at the end of the third year. Restricted stock units awarded in January 2021 contained a performance condition related to specified clinical milestones.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Share Option Valuation
The assumptions used in the Black-Scholes option pricing model to determine the fair value of the share options granted by the Company during the nine months ended September 30, 2021 were as follows:
| September 30, | |
|---|---|
| 2021 | |
| Expected option life (years) | 5.27 to 6.08 years |
| Risk-free interest rate | 0.62% to 1.14% |
| Expected volatility | 80.05% to 84.35% |
| Expected dividend yield | —% |
Share Options
The table below summarizes activity for the nine months ended September 30, 2021:
| Number of <br>Options | Weighted-Average Exercise Price | Weighted-Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value | |||
|---|---|---|---|---|---|---|
| Outstanding as of December 31, 2020 | 5,611,429 | $ | 17.19 | 7.96 years | $ | 4,262 |
| Granted | 2,678,175 | 7.90 | — | |||
| Exercised | (192,844) | 0.64 | — | |||
| Canceled or forfeited | (1,753,479) | 15.75 | — | |||
| Outstanding as of September 30, 2021 | 6,343,281 | $ | 14.18 | 8.25 years | $ | 948 |
| Exercisable as of September 30, 2021 | 2,764,732 | 18.43 | 7.38 years | $ | 484 | |
| Vested and expected to vest as of September 30, 2021 | 6,343,281 | $ | 14.18 | 8.25 years | $ | 948 |
The aggregate intrinsic value of share options is calculated as the difference between the exercise price of the share options and the fair value of the Company’s ADSs for those share options that had exercise prices lower than the fair value of the Company’s ADSs.
The weighted average grant-date fair value of share options granted was $5.45 per share for the nine months ended September 30, 2021, of which none were vested at the date of these financials.
As of September 30, 2021, the total unrecognized compensation expense related to unvested options was $7.1 million, which the Company expects to recognize over a weighted average vesting period of 2.71 years.
During the nine months ended September 30, 2021, the Company granted 1,602,500 options with performance conditions related to specified clinical milestones and 212,500 options with performance conditions being forfeited. As of September 30, 2021, the performance conditions were not determined to be probable and no expense was recorded for the nine months ended September 30, 2021.
During the nine months ended September 30, 2021, 80,000 share options, which were granted with performance conditions in the first quarter of 2021, vested in the three months ended September 30, 2021. These share options were modified to remove the performance conditions, thereby accelerating the vesting, and related expense, to the current period.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Restricted Ordinary Shares
A summary of the changes in the Company’s restricted ordinary shares during the nine months ended September 30, 2021 is as follows:
| Number of <br>restricted <br>shares | Weighted average grant date fair value | ||
|---|---|---|---|
| Unvested and outstanding at December 31, 2020 | 90,383 | $ | 4.17 |
| Granted | — | — | |
| Vested | (90,383) | 4.17 | |
| Canceled or forfeited | — | — | |
| Unvested and outstanding at September 30, 2021 | — | $ | — |
As of September 30, 2021, there was no unrecognized compensation expense.
Restricted Stock Units
A restricted stock unit (“RSU”) award represents the right to receive one of the Company’s ADSs upon vesting of the RSU. The fair value of each RSU award is based on the closing price of the Company’s ADSs on the date of grant. The Company historically granted RSU awards with service conditions that vest over a three-year service period with 50% of the award vesting one-and-half years from grant date and the remaining 50% of the award vesting at the end of the third year. In January 2021, the Company awarded RSU awards that contained a performance condition based on a condition related to a specified clinical milestone. In March 2021, the Company awarded RSU awards with service conditions that vest over a four-year service period with 25% on the first anniversary of the grant date, and the balance vesting quarterly over the remaining three years. In July 2021, the Company awarded RSU awards with service conditions that vest over a two-year period with 100% of the award vesting on the second anniversary of the grant date.
The following is a summary of RSU award activity for the 2018 Plan for the nine months ended September 30, 2021:
| Number of <br>restricted <br>shares | Weighted average grant date fair value | ||
|---|---|---|---|
| Unvested and outstanding at December 31, 2020 | 415,000 | $ | 12.09 |
| Granted | 1,215,650 | 8.27 | |
| Vested | (204,500) | 11.49 | |
| Canceled or forfeited | (320,850) | 10.33 | |
| Unvested and outstanding at September 30, 2021 | 1,105,300 | $ | 8.62 |
As of September 30, 2021, there was $1.3 million of unrecognized compensation expense related to unvested RSU awards, which are expected to be recognized over a weighted average vesting period of 2.05 years.
During the nine months ended September 30, 2021, the Company awarded an aggregate of 1,020,000 RSU awards with a performance condition related to a specified clinical milestone and an aggregate of 140,000 RSU awards with performance conditions were forfeited. As of September 30, 2021, the performance condition was not determined to be probable and accordingly, no expense was recorded for the nine months ended September 30, 2021.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
During the nine months ended September 30, 2021, 41,125 RSU awards vested however, were not issued as of September 30, 2021, and as such are not included in the Company's outstanding shares at September 30, 2021. 40,000 of these RSU awards, which were granted with performance conditions in the first quarter of 2021, vested in the three months ended September 30, 2021. These RSU awards were modified to remove the performance conditions, thereby accelerating the vesting, and related expense, to the current period.
Share-based Compensation Expense
Share-based compensation expense recorded as research and development expenses, general and administrative expenses, and capitalized to property and equipment is as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended<br>September 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||
| Research and development | $ | 556 | $ | 2,183 | $ | (238) | $ | 10,450 |
| General and administrative | 946 | 2,062 | 2,350 | 5,423 | ||||
| Capitalized | — | — | — | (87) | ||||
| Total share-based compensation | $ | 1,502 | $ | 4,245 | $ | 2,112 | $ | 15,786 |
The decrease in share-based compensation expense of $2.7 million and $13.7 million in the three and nine months ended September 30, 2021 respectively, relates a combination of the following: (i) an increase in forfeitures of share-based payment awards as a result of the reduction in workforce that took place during the nine month period, ii) significantly lower grant date fair values during the period compared to the same period in 2020, and iii) the full amortization of expense for awards which have fully vested.
Note 8. License Agreements
UCL Business plc License
In September 2014, the Company entered into an exclusive license agreement (the “License”) with UCL Business Ltd. (“UCLB”), the technology transfer company of University College London (“UCL”), to obtain licenses to certain technology rights in the field of cancer therapy and diagnosis. In March 2016, the License was amended to include additional rights.
As part of the consideration for the License in September 2014, the Company issued 1,497,643 ordinary shares to UCLB. The Company paid upfront fees of $0.3 million and issued an additional 313,971 ordinary shares to UCLB when the License was amended in March 2016.
In March 2018, the License was further amended and restated to include a license to the Company's product candidate, AUTO1, for which UCL is conducting Phase 1 clinical trials of AUTO1 in pediatric and adult ALL patients. The Company paid an upfront fee of £1.5 million for consideration for the amended and restated License and paid the additional £0.35 million in connection with UCLB's transfer of clinical data to the Company in December 2020. No equity was issued as part of the upfront fee consideration.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Additionally, the Company may be obligated to make payments to UCLB under the amended and restated License upon the initiation of certain clinical activities in an aggregate amount of £0.18 million, the receipt of specified regulatory approvals in an aggregate amount of £37.5 million, the start of commercialization in an aggregate amount of £18 million, and the achievement of net sales levels in an aggregate amount of £51 million, as well as royalty payments based on possible future sales resulting from the utilization of the licensed technologies. On a per-product basis, these milestone payments range from £1 million to £18.5 million, depending on which T cell programming modules are used in the product achieving the milestone.
Upon commercialization of any of the Company’s products that use the in-licensed patent rights, the Company will be obligated to pay UCLB a flat royalty for each licensed product ranging from the low- to mid-single digits, depending on which technologies are deployed in the licensed product, based on worldwide annual net sales of each licensed product, subject to certain reductions, including for the market entry of competing products and for loss of patent coverage of licensed products. The Company may deduct from the royalties payable to UCLB one-half of any payments made to a third party to obtain a license to such third party’s intellectual property that is necessary to exploit any licensed products. Once net sales of a licensed product have reached a certain specified threshold, the Company may exercise an option to buy out UCLB’s rights to the remaining milestone payments, royalty payments, and sublicensing revenue payments for such licensed product, on terms to be negotiated at the time.
The License expires on a product-by-product and country-by-country basis upon the expiration of the royalty term with respect to each product in each country. The Company may unilaterally terminate the license agreement for any reason upon advance notice to UCLB. Either party may terminate the License for the uncured material breach by the other party or for the insolvency of the other party. If UCLB terminates the License following the Company’s insolvency or the Company’s material breach of the License, or if the Company terminates the License unilaterally, all rights and licenses granted to the Company will terminate, and all patent rights and know-how transferred to the Company pursuant to the License will revert back to UCLB, unless and to the extent the Company has exercised its option to acquire ownership of the licensed patent rights. In addition, UCLB has the right to negotiate with the Company for the grant of an exclusive license to the Company’s improvements to the T cell programming modules the Company has licensed on terms to be agreed upon at the time.
Noile-Immune Biotech Inc.
In November 2019, the Company entered into an exclusive license agreement with Noile-Immune Biotech Inc. ("Noile") under which the Company will have the right to develop CAR T cell therapies incorporating Noile’s PRIME (proliferation-inducing and migration-enhancing) technology. The PRIME technology is designed to improve proliferation and trafficking into solid tumors of both engineered CAR T cells as well as the patient’s own T cells.
The Company paid an upfront fee to Noile upon execution of the agreement and may be obligated to make additional payments to Noile upon the achievement of development milestones and receipt of regulatory approvals product sale milestones, as well as royalty payments based on possible future sales resulting from the utilization of the licensed technology.
Note 9. Income Taxes
The provision for income taxes is based upon the estimated annual effective tax rates for the year applied to the current period loss before tax plus the tax effect of any significant unusual items, discrete events or changes in tax law. Fluctuations in the distribution of pre-tax income among the Company’s operating subsidiaries can lead to fluctuations of the effective tax rate in the unaudited condensed consolidated financial statements. In the three months ended September 30, 2021 and 2020, the actual effective tax rates were 13.7% and 17.6%, respectively and in the nine months ended September 30, 2021 and 2020, the actual effective tax rates were 14.8% and 15.9%, respectively. The changes in the effective tax rate for the three and nine months ended September 30, 2021 as compared to the three and nine months ended September 30, 2020 were due to fluctuations in the forecast proportion of qualifying research and development expenditure for the year.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The actual effective tax rates are lower than the 19% statutory rate of U.K. tax primarily due to the manner in which the U.K. research and development credit operates.
The tax benefit for the three months ended September 30, 2021 decreased to $5.4 million from $7.9 million for three months ended September 30, 2020 due to a decrease in forecasted qualifying research and development expenditures and the decreased effective tax rate for the quarter.
The tax benefit for the nine months ended September 30, 2021 decreased to $17.5 million from $18.6 million for nine months ended September 30, 2020 due to a decrease in forecasted qualifying research and development expenditures in the nine month period.
The Company carries a $1.4 million deferred tax asset balance related to its U.S. subsidiary. The Company has recorded a valuation allowance against the net deferred tax asset where the recoverability due to future taxable profits is unknown.
Note 10. Commitments and Contingencies
License Agreement
The Company has entered into an exclusive license agreement with UCLB which has subsequently been amended and restated (see Note 8). In connection with the UCLB license agreement, the Company is required to make annual license payments and may be required to make payments upon the achievement of specified milestones. The Company has estimated the probability of the Company achieving each potential milestone in accordance with ASC 450, Contingencies. The Company concluded that, as of September 30, 2021, there were no milestones for which the likelihood of achievement was probable.
Legal Proceedings
From time to time, the Company may be a party to litigation or subject to claims incident to the ordinary course of business. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. The Company was not a party to any litigation and did not have contingency reserves established for any liabilities as of September 30, 2021 and December 31, 2020.
Leases
The Company leases certain office space, laboratory space, and equipment. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present.
The Company leased space at Forest House from Imperial Limited under a ten-year lease, the term of which commenced in September 2015. The lease included an option for the Company to lease additional space within a 15-month period, which the Company exercised in October 2016. The exercise of the option resulted in a separate new lease agreement with a concurrent term through September 2025. The landlord exercised its option to give notice in September 2020 to terminate the Forest House lease and paid the Company a break-lease payment fee in September 2021. The Company recorded a $1.3 million gain upon the notice of lease termination in the third quarter of 2020. The Company did not have a lease incentive receivable as of September 30, 2021.
In September 2017, the Company entered into a Collaboration Agreement (the “Catapult Agreement” ) with Catapult Limited (“Catapult”) to lease and occupy a certain manufacturing and office space . The Catapult Agreement was for a five and a half year term starting in September 2019. The parties may terminate the Catapult Agreement at any time without penalty by mutual understanding of both parties.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
In September 2018, the Company signed a binding letter of intent to enter into a lease for manufacturing space in Enfield, United Kingdom. The letter of intent required the Company to enter into a 15-year lease provided that the landlord completed the required leasehold improvements described in the agreement. The Company executed lease agreements for three manufacturing space units, each for 15-year lease terms. The leases commenced in February 2019 with option to terminate the lease in February 2029. In March 2021, the Company surrendered one of the units. Upon the surrender, the Company recognized a $0.1 million gain in other income after recognizing a termination fee of $0.2 million. The Company has no further obligations for the surrendered unit and the right of use asset and lease liability which were recorded for this unit have been written off in the period. The Company is actively seeking to sub-lease or assign the remaining three lease arrangements to third parties with two units under contract negotiation for sub-leases. The Company completed an asset impairment analysis of the right of use asset concluding the undiscounted cash flows exceeded the carrying value as of September 30, 2021.
In October 2018, the Company executed an agreement to sublease office space in Rockville, Maryland for a term through October 2021. The Company then terminated the sublease in February 2020 and immediately entered into a five-year lease for the same space with the landlord. As a result of the sublease termination, the Company recognized a $0.2 million gain in other income (expense) in the three months ending March 31, 2020. The lease related to this facility is classified as an operating lease. The Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability.
In January 2019, the Company executed a lease agreement to lease additional office and manufacturing space in Rockville, Maryland. The lease agreement required the Company to enter into a lease provided that the landlord completed the required leasehold improvements described in the agreement. The lease commenced in August 2020 for a term through June 2036. In March 2021, the Company announced plans to move the site of its global launch of manufacturing capacity to the United Kingdom from the United States. As a part of this strategy, the Company entered into a termination agreement with the landlord of its Rockville, Maryland property to terminate the lease for office and manufacturing space. As a result, the Company recognized a $2.0 million termination fee gain from the landlord, a $2.3 million gain from the removal of the leased right of use asset and corresponding lease liability, and expensed $2.4 million of leasehold improvements for the nine months ended September 30, 2021. The $2.0 million termination fee was received from the landlord in April 2021.
In January 2019, the Company executed a lease agreement with Whitewood Media Village GP Limited and Whitewood Media Village Nominee Limited to lease the fifth floor of MediaWorks including laboratory space which is located in London, United Kingdom. In August 2021, MediaWorks became the Company's main corporate headquarters. The lease term is nine years and eleven months with an eighteen month rent free period at the beginning of the lease term.
In May 2020, the Company executed an arrangement with Catapult Limited to lease a manufacturing suite at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom for a term through April 2024. The lease related to this facility is classified as an operating lease. In addition to base rent, the Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 11. Employee Benefit Plans
In the United Kingdom, the Company makes contributions to private defined benefit pension schemes on behalf of its employees. The Company expensed $0.5 million and $0.3 million in contributions for the three months ended September 30, 2021 and 2020, respectively, and $1.2 million and $0.6 million in contributions for the nine months ended September 30, 2021 and 2020, respectively.
In the United States, the Company established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code in October 2018. The plan covers substantially all U.S. employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company matches employee contributions up to four percent of the employee’s annual salary. The Company expensed $0.1 million and $0.1 million for the three months ended September 30, 2021 and 2020, respectively, and $0.3 million and $0.1 million for the nine months ended September 30, 2021 and 2020, respectively. The Company pays all administrative fees related to the 401(k) plan.
Note 12. Subsequent Events
The Company evaluated subsequent events through November 3, 2021, the date on which these financial statements were issued. The Company has concluded that no subsequent event has occurred that requires disclosure.
26
Document
Exhibit 99.2
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and the related notes to those statements included as Exhibit 99.1 to this Report on Form 6-K submitted to the Securities and Exchange Commission, or the SEC, on November 3, 2021. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2020 or the Annual Report filed with the Securities and Exchange Commission, or the SEC on March 4, 2021.
We maintain our books and records in pounds sterling, our results are subsequently converted to U.S. dollars and we prepare our consolidated financial statements in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, as issued by the Financial Accounting Standards Board, or FASB. All references in this Report on Form 6-K to “$” are to U.S. dollars and all references to “£” are to pounds sterling. Our consolidated statements of operations for the three months ended September 30, 2021 and 2020 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3784 and £1.00 to $1.2919 respectively. Our consolidated statements of operations and cash flows for the nine months ended September 30, 2021 and 2020 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3848 and £1.00 to $1.2718 respectively. Our consolidated balance sheets as of September 30, 2021 and December 31, 2020 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3458 and £1.00 to $1.2917, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as of that or any other date.
Unless otherwise indicated or the context otherwise requires, all references to “Autolus,” the “Company,” “we,” “our,” “us” or similar terms refer to Autolus Therapeutics plc and its consolidated subsidiaries.
The statements in this discussion regarding our expectations regarding our future performance, liquidity and capital resources and other non-historical statements are forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of our Annual Report and any subsequent reports that we file with the SEC.
Overview
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 recognize cancer cells, break down their defense mechanisms and attack and kill 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.
In recent years, we have devoted substantially all of our resources to conducting preclinical studies and clinical trials, 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 proceeds from government grants and sales of our equity securities, including the net proceeds from our initial public offering of American Depository Shares, or ADSs, in June 2018 as well as from follow-on public offerings of our ADSs. From our inception in 2014 through September 30, 2021, we have received aggregate net proceeds of $652.6 million from sales of our equity securities. We do not expect to generate significant revenue unless and until we obtain marketing approval for and commercialize one of our product candidates.
Since our inception, we have incurred significant operating losses. For the nine months ended September 30, 2021 and 2020, we incurred a net loss of $100.4 million and $99.2 million, respectively, and had an accumulated deficit of $479.7 million as of September 30, 2021.
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-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 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 favorable 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-licenses or acquisitions.
As of September 30, 2021, we had cash on hand of $173.1 million. Based on our current clinical development plans, we believe our existing cash and cash equivalents, when combined with the $25 million of additional cash which we received in October 2021 from our 2020 UK research and development tax credit, will be able to fund our current and planned operating expenses and capital expenditure requirements through at least the next 12 months. 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.
Recent Developments
ATM Facility
In September 2020, we entered into an Open Market Sale Agreement, or the Sales Agreement, with Jefferies LLC, or Jefferies, under which we may, at our option, offer and sell ADSs having an aggregate offering price of up to $100 million from time to time through Jefferies, acting as sales agent. Any such sales made through our sales agent can be made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act, or in other transactions pursuant to an effective shelf registration statement on Form F-3. We have agreed to pay Jefferies a commission of 3.0% of the gross proceeds of any sales of ADSs sold pursuant to the Sales Agreement. During the three months ended September 30, 2021 we did not issue any ADSs under the Sales Agreement. During the nine months ended September 30, 2021 we issued an aggregate of 3,787,972 ADSs under the Sales Agreement for net proceeds, after underwriting discounts and offering expenses, of $29.6 million.
COVID-19 Response
In response to the ongoing coronavirus 2019, or COVID-19, pandemic, the we established a cross-functional task force and have implemented business continuity plans designed to address and mitigate our impact on the our employees and business. While we have has 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 its business, financial condition, results of operations and growth prospects to be materially adversely affected.
We have implemented a COVID-19 surveillance testing program available to Company staff who work on-site at the Company’s U.K. facility to minimize the spread of COVID-19 within the Company. 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 it 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.
Realignment of Program Prioritization and Corporate Adjustments
In January 2021, we announced the restructuring of our R&D strategy and namely, the prioritization of the AUTO1 program. We intend 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 during the first quarter of 2021, which involved an overall reduction in headcount of approximately 20%. This reduction in headcount is now complete.
Re-alignment of Manufacturing Operations
In March 2021, we announced our plans to establish global commercial launch capacity in the United Kingdom as opposed to the United States, enabling us to leverage the expertise and skill base of our U.K.-based employees. Our proposed manufacturing growth in the United Kingdom will be supported by a combination of the extension of our existing clinical trial manufacturing facility at The Cell and Gene Therapy Catapult facility as well as a new manufacturing facility. This revised strategy aims to deliver a less capital-intensive commercial manufacturing infrastructure at a lower cost base. In conjunction with this new strategy, we terminated our lease for a manufacturing and office facility in Rockville, Maryland, which triggered a cash payment of $2.0 million to us and ended all of our prior payment obligations under the lease. We disposed of leasehold improvements in connection with the termination of the lease and expensed $2.4 million in the unaudited condensed consolidated statements of operations and comprehensive loss for the nine months ended September 30, 2021.
On September 16, 2021 we announced that planning approval has been granted to build our 70,000 square foot manufacturing facility in Stevenage, United Kingdom.
Global commercial launch capacity for obecabtagene autoleucel ("obe-cel") will initially be provided by the existing clinical trial manufacturing facility at The Cell and Gene Therapy Catapult facility, and will then move to the new facility that is being built in Stevenage, which will allow for Good Manufacturing Practice, or GMP capacity for approximately 2,000 batches a year initially, with potential to expand.
Components of Our Results of Operations
Grant Income
Grant income consists of proceeds from government research grants used to perform specific research and development activities. We recognize grant income over the period in which we recognize the related costs covered under the terms and conditions of the grant. We have received grants from the U.K. government, which are repayable under certain circumstances, including breach or noncompliance with the terms of the grant. For grants with refund provisions, we review the grant to determine the likelihood of repayment. If the likelihood of repayment of the grant is determined to be remote, then the grant is recognized as grant income. We have concluded that the likelihood of any repayment events included in our current grants is remote.
License Revenue
We account for our revenue pursuant to the provisions of Accounting Standards Codification, or ASC Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”).
The Company has no products approved for commercial sale and has not generated any revenue from commercial product sales. The total revenue to date has been generated principally from license agreements. The terms of an agreement which was entered into during the nine months ended September 30, 2021, included a non-refundable upfront license fee, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on product sales. We did not record any license revenue for three months ended September 30, 2021 and recorded $0.2 million of license revenue for the three months ended September 30, 2020. We recognized $1.5 million and $0.2 million of license revenue for the nine months ended September 30, 2021, and September 30, 2020, respectively.
In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation.
License Fees and Multiple Element Arrangements
If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, upfront fees allocated to the license at such time as the license is transferred to the licensee and the licensee is able to use, and benefit from, the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligations to determine whether the combined performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, we consider the nature of service that we promise to transfer to the customer. When we decide on a method of measurement, we will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances.
Customer Options
If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options that are not determined to be material rights are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. We evaluate the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. We allocate the transaction price to material rights based on the relative standalone selling price, which is determined based on any identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised. During the three and nine months ended September 30, 2021 and September 30, 2020 we did not recognize any revenue related to customer options.
Contingent Research Milestone Payments
ASC Topic 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example.
If the consideration in a contract includes a variable amount, we will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if our entitlement to the consideration is contingent on the occurrence or non-occurrence of a future event. We consider contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period.
We assess whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestone revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant.
GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinate. We consider all relevant factors.
For three and nine months ended September 30, 2021 and September 30, 2020, we have not recognized any variable consideration with regards to the development milestones, which are included in the license agreements that were executed in the current and prior periods. This is due to the fact that those development milestones have not yet been met and the recognition of the related revenue is not yet probable.
Royalty Revenue
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
For three and nine months ended September 30, 2021 and September 30, 2020, the Company has not recognized any royalty revenue from in the license agreements that were executed in the current and prior periods. This is due to the fact that there are no related sales for the technology which was licensed in the agreements.
Operating Expenses
Research and Development Expenses
Research and development expenses consist of costs incurred in connection with the research and development of our product candidates, which are partially offset by U.K. research and development expenditure tax credits provided by Her Majesty’s Revenue & Customs, or HMRC. We expense research and development costs as incurred. These expenses include:
•expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
•manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials;
•employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in research and development functions;
•expenses incurred for outsourced professional scientific development services;
•costs for laboratory materials and supplies used to support our research activities;
•allocated facilities costs, depreciation and other expenses, which include rent and utilities; and
•upfront, milestone and management fees for maintaining licenses under our third-party licensing agreements.
We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers.
Our direct research and development expenses are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as fees paid to outside consultants and CROs in connection with our preclinical development, manufacturing and clinical development activities. Our direct research and development expenses by program also include fees incurred under license agreements. We do not allocate employee costs or facility expenses, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to oversee research and development as well as for managing our preclinical development, process development, manufacturing and clinical development activities.
The following tables provide additional detail on our research and development expenses:
| Three Months Ended September 30, | ||||||
|---|---|---|---|---|---|---|
| 2021 | 2020 | Change | ||||
| (in thousands) | ||||||
| Direct research and development expenses | ||||||
| B cell malignancies (AUTO1 & AUTO3) | $ | 8,165 | $ | 8,824 | $ | (659) |
| Other projects (AUTO4, AUTO5, AUTO6, AUTO7 & AUTO8) | 1,002 | 633 | 369 | |||
| Total direct research and development expense | $ | 9,167 | $ | 9,457 | $ | (290) |
| Research and discovery expense and unallocated costs: | ||||||
| Personnel related (including share-based compensation) | 11,905 | 12,735 | (830) | |||
| Indirect research and development expense | 11,220 | 11,353 | (133) | |||
| Total research and development expenses | $ | 32,292 | $ | 33,545 | $ | (1,253) |
| Nine Months Ended September 30, | ||||||
| 2021 | 2020 | Change | ||||
| (in thousands) | ||||||
| Direct research and development expenses | ||||||
| B cell malignancies (AUTO1 & AUTO3) | $ | 19,869 | $ | 21,271 | $ | (1,402) |
| Other projects (AUTO4, AUTO5, AUTO6, AUTO7 & AUTO8) | 3,409 | 1,660 | 1,749 | |||
| Total direct research and development expense | $ | 23,278 | $ | 22,931 | $ | 347 |
| Research and discovery expense and unallocated costs: | ||||||
| Personnel related (including share-based compensation) | 36,707 | 42,365 | (5,658) | |||
| Indirect research and development expense | 35,169 | 30,864 | 4,305 | |||
| Total research and development expenses | $ | 95,154 | $ | 96,160 | $ | (1,006) |
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next few years as we increase personnel costs, initiate and conduct additional clinical trials and prepare regulatory filings related to our product candidates. We also expect to incur additional expenses related to milestone, royalty payments and maintenance fees payable to third parties with whom we have entered into license agreements to acquire the rights related to our product candidates.
The successful development and commercialization of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from sales of any of our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with development and commercialization activities, including the uncertainty of:
•the scope, progress, outcome and costs of our clinical trials and other research and development activities, including establishing an appropriate safety profile with IND enabling studies;
•successful patient enrollment in, and the initiation and completion of, clinical trials;
•the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
•establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
•development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial manufacturing;
•obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
•significant and changing government regulation;
•launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others;
•maintaining a continued acceptable safety profile of the product candidates following approval; and
•significant competition and rapidly changing technologies within the biopharmaceutical industry.
We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. Any changes in the outcome of any of these variables with respect to the development of our product candidates in clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if a regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate. Commercialization of our product candidates will take several years and millions of dollars in development costs.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance, legal and administrative functions. General and administrative expenses also include allocated facility-related costs, patent filing and prosecution costs and professional fees for marketing, insurance, legal, consulting, accounting and audit services.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support the planned development of our product candidates. We anticipate continued increased costs associated with being a public company listed in the United States, including accounting, audit, legal, regulatory and compliance expenses associated with maintaining compliance with Nasdaq listing rules and SEC requirements, director and officer insurance premiums, and higher investor and public relations costs.
Additionally, if we believe a regulatory approval of one of our product candidates appears likely, we would anticipate an increase in payroll and third party expense as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of our product candidate.
Other Income / (Expense)
Other income (expense) consists primarily of interest income earned on our cash balances held at commercial banks and foreign currency transaction gains (losses). In the three and nine months ended September 30, 2021 and 2020, other income also included gains recognized on termination of leases, subleases, and a lease incentive, net.
Income Tax Benefit
We are subject to corporate taxation in the United Kingdom and in the United States. Due to the nature of our business, we have generated losses since inception. Our income tax benefit recognized represents the sum of the research and development tax credits recoverable in the United Kingdom and income tax payable in the United States.
As a company that carries out extensive research and development activities, we benefit from the U.K. research and development tax credit regime under the scheme for small or medium-sized enterprises, or SMEs, and also claim a Research and Development Expenditure Credit, or RDEC, to the extent that our projects are grant funded. Under the SME regime, we are able to surrender some of our trading losses that arise from our qualifying research and development activities for a cash rebate of up to 33.35% of such qualifying research and development expenditure. The net tax benefit of the RDEC reflected in our financial statements for the nine months ended September 30, 2021 was 10.5%. We meet the conditions of the SME regime, but also can make claims under the RDEC regime to the extent that our projects are grant funded. Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced CRO costs and utilities costs incurred as part of research projects, and do not equate directly to our reported research and development expenses. Certain subcontracted qualifying research and development expenditures are eligible for a cash rebate of up to 21.67%. A large portion of costs relating to our research and development, clinical trials and manufacturing activities are eligible for inclusion within these tax credit cash rebate claims. In October 2021, we received $25.0 million for our UK research and development tax credit related to the year ended December 31, 2020.
We may not be able to continue to claim research and development tax credits under the SME regime in the future because we may no longer qualify. However, we should continue to be able to make claims under the RDEC regime.
Un-surrendered U.K. losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $278.9 million as of September 30, 2021 and we carry a $1.4 million deferred tax asset balance related to the U.S. entity. We have recorded a valuation allowance against the net deferred tax asset where the recoverability due to future taxable profits is unknown. The change in the UK tax rate to 25% from 1 April 2023, enacted during the quarter ended June 30, 2021, does not impact our results because the United Kingdom is in a full valuation allowance position.
In the event we generate revenues in the future, we may benefit from the United Kingdom “patent box” regime that allows profits attributable to revenues from patents or patented products to be taxed at an effective rate of 10%.
Value Added Tax, or VAT, is broadly charged on all taxable supplies of goods and services by VAT-registered businesses. Under current rates, an amount of 20% of the value, as determined for VAT purposes, of the goods or services supplied is added to all sales invoices and is payable to HMRC. Similarly, VAT paid on purchase invoices is generally reclaimable from HMRC.
Results of Operations
Comparison of Three Months Ended September 30, 2021 and 2020
The following table summarizes our results of operations for the three months ended September 30, 2021, and 2020 (in thousands):
| Three Months Ended September 30, | ||||||
|---|---|---|---|---|---|---|
| 2021 | 2020 | Change | ||||
| Grant income | $ | 236 | $ | 438 | $ | (202) |
| License revenue | — | 242 | (242) | |||
| Operating expenses: | ||||||
| Research and development | (32,292) | (33,545) | 1,253 | |||
| General and administrative | (8,299) | (9,843) | 1,544 | |||
| Total operating expenses, net | (40,355) | (42,708) | 2,353 | |||
| Other income (expense): | ||||||
| Interest income | 28 | 37 | (9) | |||
| Other income (expense) | 951 | (2,509) | 3,460 | |||
| Total other income (expense), net | 979 | (2,472) | 3,451 | |||
| Net loss before income tax | (39,376) | (45,180) | 5,804 | |||
| Income tax benefit | 5,385 | 7,865 | (2,480) | |||
| Net loss attributable to ordinary shareholders | $ | (33,991) | $ | (37,315) | $ | 3,324 |
Grant Income
Grant income decreased by $0.2 million from $0.4 million for the three months ended September 30, 2021. The decrease is due to a corresponding decrease in reimbursable expenditures.
License Revenue
There was no license revenue in the three months ended September 30, 2021, as compared to $0.2 million for the three months ended September 30, 2020. This is due to the fact that no licenses were granted in the current period.
Research and Development Expenses
Research and development expenses decreased to $32.3 million for the three months ended September 30, 2021 from $33.5 million for the three months ended September 30, 2020. Cash costs, which exclude depreciation and amortization as well as share-based compensation, decreased to $29.4 million from $30.0 million. The decrease in research and development cash costs of $0.6 million consisted primarily of (i) $1.4 million decrease in clinical costs and manufacturing costs (ii) $0.2 million decrease of consultancy fees related to our clinical pipeline, (iii) $0.3 million decrease in facilities costs related to the termination of our US manufacturing facility and shift in manufacturing strategy, (iv) $0.4 million in research and development costs related to cell logistics and (v) $0.1 million decrease related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations . This was offset by (i) an increase of $1.0 million related to purchased consumables for the manufacture of obe-cel in our Phase 2 FELIX clinical trial and (ii) an increase in compensation and employment related costs of $0.8 million net, due to a combination of severance payments which are offset by a reduction in employment costs for a decrease in headcount.
Non-cash costs decreased to $2.9 million for the three months ended September 30, 2021 from $3.5 million for the three months ended September 30, 2020. The decrease is primarily related to share-based compensation expense included in research and development expenses, which decreased by $1.6 million as a result of the lower fair value of stock options granted during the period, combined with forfeitures of incentive share options and unvested RSU awards. This was offset by an increase in depreciation expense of $1.0 million.
General and Administrative Expenses
General and administrative expenses decreased to $8.3 million for the three months ended September 30, 2021 from $9.8 million for the three months ended September 30, 2020. Cash costs, which exclude depreciation expense as well as share-based expense compensation decreased to $7.2 million from $7.7 million. The decrease in general and administrative cash costs of $0.5 million related to decreases of (i) $0.2 million associated with compensation expense due to a reduction in headcount, (ii) $0.8 million of expenses related to preparations for becoming a commercial stage company, and (iii) $0.4 million in facilities costs related to the termination of a lease and exit of our lease agreements. These decreases were offset by an increase of $0.8 million which was primarily related to professional services fees and directors and officers liability insurance premiums and $0.1 million in costs related to IT infrastructure and support for information systems.
Non-cash costs decreased to $1.1 million for the three months ended September 30, 2021 from $2.1 million for the three months ended September 30, 2020. The decrease is mainly attributed to share-based compensation expense as a result of the lower fair value of stock options granted during the period, combined with forfeitures of incentive share options and unvested RSU awards related to employees affected by our reduction in workforce.
Other Income / (Expense)
Other income / (expense) increased by $3.5 million for the three months ended September 30, 2021, from other expense of $2.5 million for the three months ended September 30, 2020 to other income of $1.0 million. The increase was primarily due to the strengthening of the U.S. dollar exchange rate relative to the pound sterling during the three months ended September 30, 2021 as compared to the three months ended September 30, 2020.
Income Tax Benefit
Income tax benefit decreased to $5.4 million for the three months ended September 30, 2021 from $7.9 million for the three months ended September 30, 2020 due to a decrease in the research and development expenditures which were qualifying for the quarter. As research and development credits fell at a faster rate than our net loss before income tax, this led to a lower effective tax rate. Research and development credits are obtained at a maximum rate of 33.35% of our qualifying research and development expenses, and the decrease in the net credit was primarily attributable to a decrease in our eligible research and development expenses.
Comparison of Nine Months Ended September 30, 2021 and 2020
The following table summarizes our results of operations for the nine months ended September 30, 2021, and 2020 (in thousands):
| Nine Months Ended September 30, | ||||||
|---|---|---|---|---|---|---|
| 2021 | 2020 | Change | ||||
| Grant income | $ | 643 | $ | 1,069 | $ | (426) |
| License revenue | 1,507 | 242 | 1,265 | |||
| Operating expenses: | ||||||
| Research and development | (95,154) | (96,160) | 1,006 | |||
| General and administrative | (24,274) | (25,966) | 1,692 | |||
| Loss on disposal of leasehold improvements | (672) | — | (672) | |||
| Total operating expenses, net | (117,950) | (120,815) | 2,865 | |||
| Other income (expense): | ||||||
| Interest income | 113 | 500 | (387) | |||
| Other (expense) income | (59) | 2,500 | (2,559) | |||
| Total other income, net | 54 | 3,000 | (2,946) | |||
| Net loss before income tax | (117,896) | (117,815) | (81) | |||
| Income tax benefit | 17,466 | 18,582 | (1,116) | |||
| Net loss attributable to ordinary shareholders | (100,430) | (99,233) | $ | (1,197) |
Grant Income
Grant income decreased to $0.6 million for the nine months ended September 30, 2021 compared to $1.1 million for the nine months ended September 30, 2020. The decrease in grant income of $0.4 million was related to a decrease in reimbursable expenditures.
License Revenue
The $1.5 million of license revenue relates to the grant of a license in the nine months ended September 30, 2021 compared to $0.2 million in the nine months period ended September 30, 2020.
Research and Development Expenses
Research and development expenses decreased to $95.2 million for the nine months ended September 30, 2021 from $96.2 million for the nine months ended September 30, 2020. Cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $89.3 million from $82.2 million. The increase in research and development cash costs of $7.1 million consisted primarily of (i) an increase in compensation and employment related costs of $5.0 million due to a combination of an increase in employee headcount to support the advancement of our product candidates in clinical development and severance payments related to the reduction in workforce that was initiated during the first quarter of 2021, (ii) $2.8 million increase in facilities costs related to the continued scaling of manufacturing operations, (iii) $1.4 million increase in purchased consumables used in the manufacturing of obe-cel in the FELIX study, (iv) $0.3 million increase in costs related to cell logistics, (v) $0.6 million increase costs for the support for information systems related to the conduct of clinical trials and manufacturing operations. Increases were partially offset by a decrease in clinical costs of $2.2 million and of $0.8 million in consultancy fees related to our clinical pipeline.
Non-cash costs decreased to $5.9 million for the nine months ended September 30, 2021 from $14.0 million for the nine months ended September 30, 2020. The decrease is primarily related to share-based compensation expense included in research and development expenses, which decreased by $10.6 million as a result of lower fair value of stock options recognized in the period, combined with forfeitures of incentive share options and unvested RSU awards related to employees affected by the reduction in workforce. This was offset by an increase of $2.5 million in depreciation expense.
General and Administrative Expenses
General and administrative expenses decreased to $24.3 million for the nine months ended September 30, 2021 from $26.0 million for the nine months ended September 30, 2020. Cash costs, which exclude depreciation expense as well as share-based expense compensation increased to $21.5 million from $20.2 million. The increase in general and administrative cash costs related to increases of (i) $0.1 million in facilities costs, (ii) $1.9 million in professional service fees and increased directors and officers liability insurance premiums, (iii) an increase of $0.2 million of expenses for information technology and telecoms. These increases were offset primarily by decreases of (i) $0.8 million of expenses related to preparations for becoming a commercial stage company, and (ii) $0.1 million of employee compensation expense.
Non-cash costs decreased to $2.8 million for the nine months ended September 30, 2021 from $5.8 million for the nine months ended September 30, 2020. The decrease of $3.0 million is primarily attributed to both the lower fair value of stock options recognized during the period and the forfeitures of incentive share options and unvested RSU awards.
Loss on Disposal of Leasehold Improvements
Loss on disposal of leasehold improvements of $0.7 million related to the leasehold improvements no longer being utilized in our former facility in White City, London.
Interest Income
Interest income decreased to $0.1 million for the nine months ended September 30, 2021 compared to $0.5 for the nine months ended September 30, 2020. This decrease is due to the lower interest rates for cash held on deposit.
Other (Expense) / Income
Other (expense) / income decreased from an other income of $2.5 million to an other expense of $0.1 million for the nine months ended September 30, 2021. The decrease of $2.6 million is primarily due to a decrease of $4.6 million due to the weakening of the U.S. dollar exchange rate relative to the pound sterling during the nine months ended September 30, 2021 as compared to the nine months ended September 30, 2020, offset by gains on lease terminations of $2.0 million, net of the related expenses.
Income Tax Benefit
Income tax benefit decreased to $17.5 million for the nine months ended September 30, 2021 from $18.6 million for the nine months ended September 30, 2020 due to a decrease in the research and development expenditures which were qualifying for the nine month period ended September 30, 2021. As research and development credits fell at a faster rate than our net loss before income tax, this led to a lower effective tax rate. Research and development credits are obtained at a maximum rate of 33.35% of our qualifying research and development expenses, and the decrease in the net credit was primarily attributable to an decrease in our eligible research and development expenses.
Liquidity and Capital Resources
Since our inception, we have not generated any product revenue and have incurred operating losses and negative cash flows from our operations. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates through preclinical and clinical development, and seek regulatory approval and pursue commercialization of any approved product candidates. We expect that our research and development and general and administrative costs will increase in connection with our planned research, clinical development and potential commercialization activities. As a result, we will need additional capital to fund our operations until such time as we can generate significant revenue from product sales.
We do not currently have any approved products and have never generated any revenue from product sales. We have funded our operations to date primarily with proceeds from government grants and sales of our equity securities, primarily through public offerings and our at the market facility program. From our inception in 2014 through September 30, 2021, we have received aggregate net cash proceeds of $652.6 million from sales of our equity securities. As of September 30, 2021, we had cash on hand of $173.1 million.
Cash Flows
The following table summarizes our cash flows for each of the periods presented:
| September 30, | ||||
|---|---|---|---|---|
| 2021 | 2020 | |||
| (in thousands) | ||||
| Net cash used in operating activities | $ | (108,703) | $ | (90,028) |
| Net cash used in investing activities | (7,272) | (9,209) | ||
| Net cash provided by financing activities | 136,648 | 74,023 | ||
| Effect of exchange rate changes on cash and restricted cash | (1,488) | (7,735) | ||
| Net increase (decrease) in cash and restricted cash | $ | 19,185 | $ | (32,949) |
Net Cash Used in Operating Activities
During the nine months ended September 30, 2021, operating activities used $108.7 million of cash, resulting from our net loss of $100.4 million, and net cash used resulting from changes in our operating assets and liabilities of $17.8 million, partially offset by non-cash charges of $9.5 million. Net cash used resulting from changes in our operating assets and liabilities for the nine months ended September 30, 2021 consisted primarily of a $22.4 million increase in prepaid expenses and other current and non-current assets, $1.5 million of which related to license revenue receivable due to the grant of a license in the period, and $16.8 million related to the UK research and development tax credits. There was a decrease in accrued expenses and other liabilities of $2.9 million, and a decrease in accounts payable of $0.8 million. This cash used was offset by a decrease in long term deposits of $0.8 million, and a $1.7 million decrease in right of use assets from amortization and lease liabilities, net.
During the nine months ended September 30, 2020, operating activities used $90.0 million of cash, resulting from our net loss of $99.2 million, and net cash used resulting from changes in our operating assets and liabilities of $9.2 million, partially offset by non-cash charges of $18.4 million. Net cash used resulting from changes in our operating assets and liabilities for the nine months ended September 30, 2020 consisted primarily of a $15.3 million increase in prepaid expenses and other assets, current and non-current, an increase in accrued expenses and other liabilities of $5.0 million, an increase in accounts payable of $0.5 million, an increase in long-term deposits of $0.5 million and an decrease of $2.6 million in operating right of use assets from amortization and a decrease of $1.4 million in lease liabilities.
Net Cash Used in Investing Activities
During the nine months ended September 30, 2021 and 2020, we used $7.3 million and $9.2 million, respectively, of cash in investing activities, all of which consisted of purchases of property and equipment.
Net Cash Provided by Financing Activities
During the nine months ended September 30, 2021, net cash provided by financing activities was $136.6 million, consisting primarily of the proceeds from sales pursuant to our Sales Agreement, with Jefferies LLC and our February 2021 follow-on offering, net of issuance costs. There was minimal cash provided by employee stock option exercises.
During the nine months ended September 30, 2020 net cash provided by financing activities was $74.0 million, consisting of $74.0 million net cash proceeds from our January 2020 follow-on offering, net of issuance costs. There was minimal cash provided by employee stock option exercises
Funding Requirements
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials of our product candidates. Our expenses will increase as we:
•seek regulatory approvals for any product candidates that successfully complete preclinical and clinical trials;
•establish a sales, marketing and distribution infrastructure in anticipation of commercializing of any product candidates for which we may obtain marketing approval and intend to commercialize on our own or jointly;
•hire additional clinical, medical and development personnel;
•expand our infrastructure and facilities to accommodate our growing employee base; and
•maintain, expand and protect our intellectual property portfolio.
Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, clinical costs, external research and development services, laboratory and related supplies, legal and other regulatory expenses, and administrative and overhead costs. Our future funding requirements will be heavily determined by the resources needed to support development of our product candidates. We currently have no ongoing material financing commitments, such as lines of credit or guarantees, which are expected to affect our liquidity over the next five years, other than our lease obligations and supplier purchase commitments.
Based on our current clinical development plans, we believe our existing cash of $173.1 million at September 30, 2021 will be sufficient to fund our current and planned operating expenses and capital expenditure requirements for at least the next 12 months. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. If we receive regulatory approval for our other product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
•the scope, progress, outcome and costs of our clinical trials and other research and development activities;
•the costs, timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
•the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
•the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;
•the costs and timing of hiring new employees to support our continued growth;
•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and
•the extent to which we in-license or acquire additional product candidates or technologies.
Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through equity offerings. To the extent that we raise additional capital through the sale of equity, the ownership interest of existing shareholders will be diluted. If we raise additional funds through other third-party funding, collaborations agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
Critical Accounting Policies and Significant Judgments and Estimates
Our unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of our unaudited condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our unaudited condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 2 to our unaudited condensed consolidated financial statements appearing in Exhibit 99.1 of this Report on Form 6-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our unaudited condensed consolidated financial statements.
Share-Based Compensation
We issue ordinary shares as well as options and other securities exercisable for or convertible into ordinary shares or ADSs as incentives to our employees and directors. To the extent such incentives are in the form of share options, the options are granted pursuant to the terms of our 2017 Share Option Plan, or the 2017 Plan, or pursuant to the terms of our 2018 Equity Incentive Plan, or the 2018 Plan. Options granted under the 2017 Plan and 2018 Plan, as well as shares granted as employee incentives, typically vest over a four-year service period with 25% of the award vesting on the first anniversary of the commencement date and the balance vesting monthly over the remaining three years, unless the awards contain specific performance vesting provisions. For equity awards issued that have both a performance vesting condition and a services condition, or performance awards, once the performance criteria is achieved, the performance awards are then subject to a four-year service vesting with 25% of the performance award vesting on the first anniversary of the performance condition being achieved, with the balance vesting monthly over the remaining three years. For certain members of senior management and directors, the board has approved an alternative vesting schedule for the equity awards. The options granted under the 2017 Plan and 2018 Plan generally expire ten years from the date of grant.
We recognize compensation expense for equity awards based on the grant date fair value of the award. We recognize share-based compensation expense for awards granted to employees that have a graded vesting schedule based on a service condition only on a straight-line basis over the requisite service period for each separately vesting portion of the award as if the award was, in substance, multiple awards (the “graded-vesting attribution method”), based on the estimated grant date fair value for each separately vesting tranche. For equity awards with a graded vesting schedule and a combination of service and performance conditions, we recognize share-based compensation expense using a graded-vesting attribution method over the requisite service period when the achievement of a performance-based milestone is probable, based on the relative satisfaction of the performance condition as of the reporting date. We do not adjust share-based compensation for estimated forfeitures and account for forfeitures when they occur.
We use the fair value of our ordinary shares, determined by reference to the closing price of our ADSs on the Nasdaq Global Select Market on the date of grant, to determine the fair value of restricted share awards.
We use the Black-Scholes option pricing model to estimate the fair value of share options. This option-pricing model requires the input of various subjective assumptions, including the option’s expected life and the price volatility of the security.
The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option pricing model and applying assumptions used in connection with option grants made during the periods covered by these unaudited condensed consolidated financial statements. Assumptions used in the option pricing model include the following:
Expected volatility. We lack company-specific historical and implied volatility information for our ADSs for expected terms greater than 3 years. Therefore, we use a combination of the historical volatility of our ADSs and also the expected share volatility based on the historical volatility of publicly traded peer companies and expect to continue to do so until such time as we have adequate historical data regarding the volatility of our own traded security price.
Expected term. The expected term of options granted represents the weighted average period of time that options granted are expected to be outstanding giving consideration to vesting schedules and our historical exercise patterns. The expected term of our share options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options.
Risk-free interest rate. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods that are approximately equal to the expected term of the award.
Expected dividend. Expected dividend yield of zero is based on the fact that we have never paid cash dividends on ordinary shares and do not expect to pay any cash dividends in the foreseeable future.
Fair value of ordinary shares. The fair market value of our ADSs underlying the option is equal to the closing price of the ADSs on the Nasdaq Global Select market on the date the grant is approved by the Board.
Income Taxes
We account for income taxes under the asset and liability method which includes the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in our financial statements. Under this approach, deferred taxes are recorded for the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. The provision for income taxes represents income taxes paid or payable for the current year plus deferred taxes. Deferred taxes result from differences between the financial statements and tax bases of our assets and liabilities, and are adjusted for changes in tax rates and tax laws when changes are enacted. The effects of future changes in income tax laws or rates are not anticipated.
We are subject to corporate income taxes in the United Kingdom and the United States. The calculation of our tax provision involves the application of U.K. tax law and requires judgment and estimates.
We evaluate the realizability of our deferred tax assets at each reporting date, and we establish a valuation allowance when it is more likely than not that all or a portion of our deferred tax assets will not be realized.
The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income of the same character and in the same jurisdiction. We consider all available positive and negative evidence in making this assessment, including, but not limited to, the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. In circumstances where there is sufficient negative evidence indicating that our deferred tax assets are not more likely than not realizable, we establish a valuation allowance.
We use a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate tax positions taken or expected to be taken in a tax return by assessing whether they are more likely than not sustainable, based solely on their technical merits, upon examination, and including resolution of any related appeals or litigation process. The second step is to measure the associated tax benefit of each position as the largest amount that we believe is more likely than not realizable. Differences between the amount of tax benefits taken or expected to be taken in our income tax returns and the amount of tax benefits recognized in our financial statements represent our unrecognized income tax benefits, which we either record as a liability or as a reduction of deferred tax assets.
Deferred Tax and Current Tax Credits
Tax on the profit or loss for the year comprises current and deferred tax. Tax is recognized in the statement of operations, except to the extent that it relates to items recognized directly in equity, in which case it is recognized in equity. Current tax is the expected tax payable on the taxable income or loss for the year, using tax rates enacted or substantively enacted at the balance sheet date, and any adjustment to tax payable in respect of previous years. Tax credits are accrued for the year based on calculations that conform to the U.K. research and development tax credit regime, under both the SME and large company regimes. We meet the conditions of the SME regime, but also can make claims under the RDEC regime to the extent that our projects are grant funded.
We may not be able to continue to claim research and development tax credits under the SME regime in the future because we may no longer qualify as a small or medium-sized company. However, we should continue to be able to make claims under the RDEC regime.
Deferred tax is recognized on temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. The amount of deferred tax is based on the expected manner of realization or settlement of the carrying amount of assets and liabilities, using tax rates enacted or substantively enacted at the balance sheet date. A deferred tax asset is recognized only to the extent that it is probable that future taxable profits will be available against which the asset can be utilized. No deferred tax assets are recognized on our losses carried forward and other attributes because there is currently no indication that we will make sufficient profits to utilize these attributes.
Accrued Research and Development Expenses
As part of the process of preparing our unaudited condensed consolidated financial statements, we are required to estimate accruals for research and development expenses. This process involves reviewing and identifying services which have been performed by third parties on our behalf and determining the value of these services. In addition, we make estimates of costs incurred to date but not yet invoiced, in relation to external clinical research organizations and clinical site costs. We analyze the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs, when evaluating the adequacy of the accrued liabilities for research and development. We make judgments and estimates in determining the accrued balance in any accounting period.
JOBS Act
The Jumpstart Our Business Startups Act, or the JOBS Act, provides that, among other things, an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. As an emerging growth company, we have irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act for implementation of new or revised accounting standards and, as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth public companies.
We also currently rely on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b), (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), or (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation to median employee compensation.
These exemptions will apply until December 31, 2023 or, if earlier, until we no longer satisfy the conditions for being an emerging growth company.
Recent Accounting Pronouncements Not Yet Adopted
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, “Summary of Significant Accounting Policies,” to our unaudited condensed consolidated financial statements included in Exhibit 99.1 of this Report on Form 6-K.
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