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Autolus(AUTL) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
Exhibit 99.1 INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | --- | --- | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------| | | | | Condensed Consolidated Balance Sheets as of September 30, 2023 (Unaudited) and December 31, 2022 | 2 | | Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months | | | Ended Sept ...
Autolus(AUTL) - 2023 Q2 - Earnings Call Transcript
2023-08-06 11:59
Autolus Therapeutics plc (NASDAQ:AUTL) Q2 2023 Earnings Conference Call August 3, 2023 8:30 AM ET Company Participants Dr. Christian Itin - CEO Dr. Lucinda Crabtree - CFO Rob Dolski - incoming CFO Julia Wilson - IR Conference Call Participants Matt Phipps - William Blair Asthika Goonewardene - Truist Financial Kelly Shi - Jefferies Noah Burhance - J.P. Morgan Operator Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Second Quarter 2023 Financial Results Conference. At this time, all part ...
Autolus(AUTL) - 2023 Q2 - Earnings Call Presentation
2023-08-04 08:03
Second Quarter Financial Results and Operational Progress ...
Autolus(AUTL) - 2023 Q2 - Quarterly Report
2023-08-02 16:00
Exhibit 99.1 | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------| | INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | | | Condensed Consolidated Balance Sheets as of June 30, 2023 (Unaudited) and December 31, 2022 | 2 | | Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2023 and 2022 (Una ...
Autolus(AUTL) - 2023 Q1 - Earnings Call Transcript
2023-05-07 11:20
Autolus Therapeutics plc (NASDAQ:AUTL) Q1 2023 Earnings Conference Call May 4, 2023 8:30 AM ET Company Participants Alexandra Deschner - IR, Consultant Christian Itin - CEO Lucinda Crabtree - CFO Conference Call Participants Mara Goldstein - Mizuho Group Matthew Phipps - William Blair Yanan Zhu - Wells Fargo Securities Gil Blum - Needham & Co. Kelly Shi - Jefferies Asthika Goonewardene - Truist Operator Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics First Quarter 2023 Financial Results ...
Autolus(AUTL) - 2023 Q1 - Earnings Call Presentation
2023-05-07 11:14
First Quarter Financial Results and Operational Progress May 4, 2023 2 Developing Next Generation Programmed T Cell Therapies Disclaimer These slides contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements i ...
Autolus(AUTL) - 2023 Q1 - Quarterly Report
2023-05-03 16:00
[Condensed Consolidated Financial Statements](index=1&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $460.0 million by March 31, 2023, from $490.3 million, primarily due to reduced cash and a decline in equity Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $343,027 | $382,436 | | Total current assets | $393,885 | $425,771 | | Total assets | $459,971 | $490,274 | | **Liabilities & Equity** | | | | Total current liabilities | $39,637 | $46,366 | | Total liabilities | $193,051 | $191,600 | | Total shareholders' equity | $266,920 | $298,674 | | Total liabilities and shareholders' equity | $459,971 | $490,274 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to $39.8 million for Q1 2023 from $37.1 million in Q1 2022, despite new license revenue, driven by higher operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | License revenue | $1,292 | $0 | | Total operating expenses, net | ($43,104) | ($41,784) | | Net loss | ($39,811) | ($37,062) | | Total comprehensive loss | ($34,170) | ($44,517) | | Basic and diluted net loss per ordinary share | ($0.23) | ($0.41) | [Condensed Consolidated Statements of Shareholders' Equity](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity) Shareholders' equity decreased from $298.7 million to $266.9 million by March 31, 2023, primarily due to the $39.8 million net loss Changes in Shareholders' Equity for Q1 2023 (in thousands) | Description | Amount | | :--- | :--- | | Balance at December 31, 2022 | $298,674 | | Share-based compensation expense | $2,416 | | Unrealized gain on foreign currency translation | $5,641 | | Net loss | ($39,811) | | **Balance at March 31, 2023** | **$266,920** | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $42.4 million in Q1 2023, leading to a $39.4 million decrease in total cash and equivalents Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($42,419) | ($35,030) | | Net cash used in investing activities | ($3,622) | ($771) | | Net cash used in financing activities | ($691) | ($1) | | Net decrease in cash, cash equivalents and restricted cash | ($39,406) | ($41,784) | | Cash, cash equivalents and restricted cash, end of period | $343,355 | $268,892 | [Notes to Condensed Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [Note 1. Nature of the Business](index=6&type=section&id=Note%201.%20Nature%20of%20the%20Business) Autolus Therapeutics, a clinical-stage biopharmaceutical company, continues to incur losses but maintains sufficient cash to fund operations for at least twelve months - The company is a biopharmaceutical firm developing next-generation programmed T cell therapies for cancer treatment[16](index=16&type=chunk) - The company has incurred recurring losses since inception, with a **net loss of $39.8 million** for the three months ended March 31, 2023, and an **accumulated deficit of $710.0 million**[16](index=16&type=chunk) - Management expects that its forecast cash will be **sufficient to fund operations for at least twelve months** from the issuance date of the financial statements[16](index=16&type=chunk) [Note 3. License Revenue](index=7&type=section&id=Note%203.%20License%20Revenue) The company recognized **$1.29 million in license revenue** in Q1 2023 from a new agreement with Cabaletta Bio Inc. for RQR8 safety switch technology - On January 9, 2023, the Company entered into an Option and License Agreement with Cabaletta Bio Inc., granting a non-exclusive license for its RQR8 safety switch technology[24](index=24&type=chunk) - The company recognized total **license revenue of $1.2 million** for the three months ended March 31, 2023, related to the Cabaletta Agreement, as the performance obligation was satisfied upon delivery of the license and know-how[24](index=24&type=chunk) [Note 7. Shareholders' Equity](index=10&type=section&id=Note%207.%20Shareholders'%20Equity) In December 2022, the company completed a public offering of **81.9 million ADSs** at $2.00 per ADS, raising **net proceeds of $152.4 million** - In December 2022, the Company completed an underwritten public offering of **81,927,012 ADSs** at a price of **$2.00 per ADS**, raising **net proceeds of $152.4 million** after underwriting discounts and offering expenses[35](index=35&type=chunk) [Note 9. Net loss per share](index=10&type=section&id=Note%209.%20Net%20loss%20per%20share) Basic and diluted net loss per share improved to **$0.23** in Q1 2023 from **$0.41** in Q1 2022, driven by a significant increase in outstanding shares Net Loss Per Share Calculation (in thousands, except share and per share data) | Description | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net loss attributable to ordinary shareholders | ($39,811) | ($37,062) | | Weighted-average number of ordinary shares | 173,825,825 | 90,914,175 | | **Net loss per share - basic and diluted** | **($0.23)** | **($0.41)** | - Potentially dilutive securities, including **13.1 million share options** and **3.3 million warrants**, were excluded from the calculation as their effect would be anti-dilutive[41](index=41&type=chunk) [Note 10. Liability related to future royalties and sales milestones, net](index=11&type=section&id=Note%2010.%20Liability%20related%20to%20future%20royalties%20and%20sales%20milestones,%20net) The liability for future royalties and sales milestones, stemming from a Blackstone agreement, increased from **$125.9 million** to **$130.8 million** by March 31, 2023, due to non-cash interest expense - The liability is related to a strategic collaboration agreement with Blackstone from November 2021, involving future royalties and sales milestones[42](index=42&type=chunk) Activity in Liability for Future Royalties (in thousands) | Description | Amount | | :--- | :--- | | Balance at December 31, 2022 | $125,900 | | Non-cash interest expense | $4,905 | | **Balance at March 31, 2023** | **$130,805** | [Note 11. Leases](index=12&type=section&id=Note%2011.%20Leases) Total lease costs for Q1 2023 decreased to **$1.1 million** from **$1.4 million**, while the weighted-average remaining lease term significantly increased to **11.9 years**, reflecting new facility agreements Lease Information (in thousands, except years and percentage) | Metric | March 31, 2023 | March 31, 2022 | | :--- | :--- | :--- | | Total lease costs | $1,121 | $1,430 | | Weighted-average remaining lease term | 11.9 years | 5.5 years | | Weighted-average discount rate | 6.87% | 7.15% | - The company is leasing a new **70,000 square foot manufacturing facility** in Stevenage, UK, which is being handed over in portions as construction completes. This has contributed to the increase in the remaining lease term[48](index=48&type=chunk) Future Fixed Lease Payments (in thousands) | Period | Amount | | :--- | :--- | | Remainder of 2023 | $4,661 | | 2024 | $5,299 | | 2025 | $3,815 | | 2026 | $3,587 | | 2027 | $3,587 | | Thereafter | $18,464 | | **Total lease payments** | **$39,413** | [Note 12. Commitments and Contingencies](index=14&type=section&id=Note%2012.%20Commitments%20and%20Contingencies) The company has license agreements with potential future milestone and royalty payments, but no milestones were deemed probable as of March 31, 2023, and no litigation was pending - The company has license agreements with UCLB, Noile, and Adaptive that include potential future milestone and royalty payments[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) - As of March 31, 2023, no milestones under these agreements were considered probable of being achieved[59](index=59&type=chunk) - The company was not a party to any litigation and had no contingency reserves as of March 31, 2023[60](index=60&type=chunk) [Note 13. Related parties](index=15&type=section&id=Note%2013.%20Related%20parties) Blackstone and Syncona are identified as related parties due to significant ownership, with several related parties purchasing **$113.0 million** in ADSs during the December 2022 public offering - Blackstone and Syncona Portfolio Limited are considered related parties as they each own **more than 10%** of the Company's outstanding voting securities[62](index=62&type=chunk)[64](index=64&type=chunk) Related Party Purchases in December 2022 Public Offering | Related Party | ADSs Purchased | Total Purchase Price (in millions) | | :--- | :--- | :--- | | Syncona Portfolio Limited | 14,000,000 | $28.0 | | Deep Track Capital, LP | 15,000,000 | $30.0 | | Qatar Investment Authority | 15,000,000 | $30.0 | | Armistice Capital, LLC | 10,000,000 | $20.0 | | Entities affiliated with Blackstone | 2,500,000 | $5.0 | | **Total** | **56,500,000** | **$113.0** | [Note 14. Subsequent Events](index=16&type=section&id=Note%2014.%20Subsequent%20Events) The company evaluated all events through May 4, 2023, and concluded no subsequent events required disclosure in the condensed consolidated financial statements - The Company evaluated subsequent events through May 4, 2023, and concluded that no event has occurred that requires disclosure[67](index=67&type=chunk)
Autolus(AUTL) - 2022 Q4 - Earnings Call Transcript
2023-03-07 19:04
Financial Data and Key Metrics Changes - Cash and cash equivalents at the end of December 2022 totaled $382.8 million, an increase from $310.7 million at the end of December 2021 [37] - Net total operating expenses for 2022 were $168 million, compared to $165 million in 2021 [37] - Net loss attributable to ordinary shareholders was $148.8 million for 2022, compared to $142.1 million for 2021, with a basic and diluted net loss per share of $1.57 compared to $1.97 in the previous year [42] Business Line Data and Key Metrics Changes - Research and development expenses increased by $7.2 million to $142 million in 2022, primarily due to increased clinical and manufacturing costs related to the obe-cel candidate [38] - General and administrative expenses remained consistent at $31.9 million for both 2022 and 2021 [39] - License revenue was $6.2 million in 2022, with potential for additional revenue from recent collaborations [13] Market Data and Key Metrics Changes - The market opportunity in relapsed refractory ALL remains unchanged, with approximately 3,000 patients in need of therapy across the U.S., Europe, and Japan [26] - Blincyto, the standard of care in relapsed refractory ALL, achieved sales of $583 million in 2022, reflecting a year-over-year growth of 24% [27] Company Strategy and Development Direction - The company plans to submit a Biologics License Application (BLA) for obe-cel by the end of 2023, with a commercial launch targeted for 2024 [11][28] - The company is focused on expanding its manufacturing capabilities with the completion of the Nucleus facility, which will support approximately two-thirds of the estimated market demand for adult ALL [15][35] - The company is exploring additional indications for obe-cel beyond ALL, including relapsed refractory non-Hodgkins lymphoma and chronic lymphoblastic leukemia [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of obe-cel, which is expected to facilitate its use in community settings [46] - The company anticipates a significant year ahead, with key milestones including regulatory submissions and data presentations planned for mid-2023 [43][44] - Management highlighted the potential for collaborations to enhance the company's pipeline and market position [44] Other Important Information - The company received a total of $70 million in milestones from Blackstone Life Sciences due to positive interim analysis results for obe-cel [12] - The company is preparing for commercialization by establishing awareness and value propositions for payors [29] Q&A Session Summary Question: What is the incidence of grade 3 CRS in the FELIX study? - Management noted that high grade CRS was less than 3% and ICANS was less than 8%, which aligns with current standards in non-academic centers, supporting broader use of the product [46] Question: What data will be included in the BLA submission? - The BLA will focus on demonstrating clinical benefit in patients with morphological disease, including time-dependent outcomes and safety profiles [48][49] Question: What is the scope of the AUTO8 study in multiple myeloma? - The AUTO8 study is a small Phase I clinical study involving around 10 patients, with initial evaluations planned [55] Question: How will obe-cel be positioned in the market? - Obe-cel is expected to be positioned in the relapsed refractory setting, potentially after Blincyto therapy, with plans to evaluate its activity in patients who have received prior treatments [56][72] Question: What are the expectations for the FELIX data? - Management expects the FELIX data to show a similar durability profile to previous studies, although long-term follow-up is required for confirmation [60][61]
Autolus(AUTL) - 2022 Q4 - Annual Report
2023-03-06 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from to OR o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...
Autolus(AUTL) - 2022 Q3 - Earnings Call Transcript
2022-11-05 02:15
Autolus Therapeutics plc (NASDAQ:AUTL) Q3 2022 Earnings Conference Call November 3, 2022 8:30 AM ET Company Participants Olivia Manser - Director, Investor Relations Christian Itin - Chief Executive Officer Lucinda Crabtree - Chief Financial Officer Conference Call Participants Mara Goldstein - Mizuho Matthew Phipps - William Blair James Shin - Wells Fargo Securities Gil Blum - Needham & Company Operator Hello ladies and gentlemen and welcome to the Autolus Therapeutics Third Quarter 2022 Financial Results ...