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Adaptimmune(ADAP) - 2024 Q2 - Earnings Call Transcript
2024-08-12 15:42
Financial Data and Key Metrics Changes - The company reported total liquidity of $215 million at the end of Q2 2024, an increase from approximately $144 million at the end of Q1 2024, indicating strong financial positioning for the launch of Tecelra and pipeline development [9][10]. - Total expenditures for the first half of 2024 were approximately $114 million, with expectations for operating expenses to remain consistent over the next 18 months [10][11]. Business Line Data and Key Metrics Changes - Tecelra, the company's first product in the sarcoma franchise, was launched following FDA approval, marking a significant milestone as the first engineered cell therapy for solid tumors [6][7]. - The company plans to activate 6 to 10 authorized treatment centers (ATCs) during the launch period, with five ATCs already available on their locator tool [8][9]. Market Data and Key Metrics Changes - The company anticipates that the ATCs will represent about 80% of the patients in sarcoma centers of excellence, which is estimated to be 50% to 70% of all sarcoma patients across the country [23]. - The expected peak US sales for the sarcoma franchise is estimated at $400 million, with a patient split of approximately 40% for Tecelra and 60% for lete-cel [35]. Company Strategy and Development Direction - The company is transitioning into a commercial cell therapy company, focusing on the successful launch of Tecelra and the development of its pipeline, including lete-cel and uza-cel [11][12]. - The company aims to redefine treatment for solid tumor cancers through its integrated cell therapy approach, leveraging its experience from Tecelra's regulatory submission for future products [11][12]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the launch of Tecelra and the potential for significant patient engagement, noting the enthusiasm from treatment centers and the sarcoma community [16][25]. - The company is focused on establishing a robust referral network and ensuring patient support through its Adaptimmune Assist program [8][25]. Other Important Information - The company has signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules, enhancing its financial flexibility [9]. - The regulatory pathway for lete-cel will mirror that of Tecelra, with expectations for primary data presentation from the IGNYTE-ESO trial later this year [37]. Q&A Session Summary Question: Early patient flow through ATCs - Management noted enthusiasm from treatment centers and reported that patients are beginning the testing journey for Tecelra, primarily from other sarcoma centers of excellence [14][16]. Question: ADP-600 program and next-generation enhancements - The Chief Scientific Officer indicated that next-gen approaches are being evaluated for the ADP-600 program, with updates to follow [18][20]. Question: Proportion of synovial sarcoma patients at ATCs - Management stated that the five active ATCs represent about 80% of the patients in sarcoma centers of excellence, with onboarding of additional centers expected [22][23]. Question: Enrollment in SURPASS-3 trial - Management confirmed that enrollment is progressing well, with a mix of US and ex-US sites, and they anticipate completing enrollment next year [30][31]. Question: Revenue split between Tecelra and lete-cel - Management provided a breakdown of expected peak sales, estimating 40% for Tecelra and 60% for lete-cel, emphasizing the importance of a gradual sales ramp-up [35][36]. Question: Timeline from patient screening to infusion - The timeline from screening to infusion is expected to take several weeks, with initial patients anticipated to be treated in the first quarter of the following year [50][51]. Question: Coverage and reimbursement for Tecelra - Medicare coverage is already established, with commercial coverage expected to follow a similar path to CAR-T therapies, initially through single-case negotiations [51][52].
Adaptimmune(ADAP) - 2024 Q2 - Quarterly Report
2024-08-12 11:23
Drug Approvals and Clinical Trials - Tecelra received FDA approval on August 1, 2024, for the treatment of advanced synovial sarcoma, showing an overall response rate (ORR) of 43% in a trial with 44 patients[115] - The median duration of response for Tecelra was 6 months, with 39% of responsive patients maintaining a response for 12 months or longer[115] - Lete-cel, targeting the NY-ESO antigen, reported an ORR of 40% in the IGNYTE-ESO trial, with a median duration of response of approximately 11 months[116] - The company is focusing on developing T-cell therapies directed to PRAME and CD70, with preclinical testing ongoing for ADP-600 and ADP-520[119] Financial Performance - Revenue increased by $123.1 million to $128.2 million for the three months ended June 30, 2024, compared to $5.1 million for the same period in 2023, primarily due to the termination of the Genentech collaboration[161] - The company reported a profit of $69.5 million for the period ended June 30, 2024, compared to a loss of $21.4 million in the same period in 2023, marking a 425% improvement[160] - Revenue increased by $81.2 million to $133.9 million for the six months ended June 30, 2024, primarily due to the termination of the Genentech collaboration, resulting in a cumulative catch-up adjustment of $101.3 million[175] - Operating loss for the six months ended June 30, 2024, was $19.4 million, a significant improvement compared to an operating loss of $43.3 million for the same period in 2023[174] Research and Development Expenses - Research and development expenses rose by 35% to $40.4 million for the three months ended June 30, 2024, compared to $30.0 million in the same period in 2023[160] - Research and development expenses for the six months ended June 30, 2024, increased by 36% to $75.7 million from $55.5 million in the same period in 2023[177] - The net increase in research and development expenses for the six months ended June 30, 2024, was primarily driven by a $9.4 million increase in salaries and related costs due to the acquisition of TCR2[179] - Subcontracted costs for the three months ended June 30, 2024, were $14.0 million, compared to $9.5 million in the same period of 2023, including $9.7 million directly associated with afami-cel, lete-cel, and uza-cel T-cells[167] Collaborations and Agreements - A clinical collaboration agreement with Galapagos NV includes an upfront payment of $70 million and potential milestone payments of up to $465 million for the TCR T-cell therapy candidate uza-cel[123] - The company expects to receive initial payments of $100 million from the Galapagos collaboration, including $70 million upfront and $30 million for research and development funding[138] - The company will recognize revenue from the Galapagos collaboration based on the percentage of completion of the proof-of-concept trial[139] - The company received an upfront payment of £7.5 million from Adaptimmune as part of the GSK Termination and Transfer Agreement[135] Cash Flow and Liquidity - The company had cash and cash equivalents of $211.8 million and Total Liquidity of $214.8 million as of June 30, 2024[187] - Net cash provided by operating activities was $15.4 million for the six months ended June 30, 2024, compared to a net cash used of $81.0 million for the same period in 2023[189] - The increase in net cash provided by operating activities was primarily due to $30.8 million in research and development credits, an $85 million upfront payment from Galapagos, and a $7.7 million milestone payment from GSK[189] - Net cash provided by financing activities was $53.7 million for the six months ended June 30, 2024, compared to $0.2 million for the same period in 2023[192] Tax and Corporate Costs - The U.K. corporation tax rate is 25% for the year ended December 31, 2024, impacting the company's tax strategy[152] - The company benefits from the U.K. SME R&D Tax Credit Scheme, allowing for a payable tax credit of up to approximately 18.6% of eligible R&D expenditures[142] - Income tax expense for the period was $1.0 million, reflecting taxable profits generated by Adaptimmune LLC in the United States[172] - The company experienced an increase of $1.8 million in other corporate costs due to higher accounting, legal, and professional fees[186] Strategic Changes and Collaborations - The termination of the Astellas Collaboration Agreement resulted in a contract modification with a transaction price of $42.4 million recognized in March 2023[130] - The termination of the Genentech collaboration led to a cumulative catch-up adjustment of $101.3 million due to the loss of future payments[134] - The gain on bargain purchase from the strategic combination with TCR2 Therapeutics Inc. occurred in June 2023[171] General and Administrative Expenses - General and administrative expenses decreased by 5% to $19.1 million for the three months ended June 30, 2024, down from $20.1 million in the same period in 2023[168] - General and administrative expenses for the six months ended June 30, 2024, decreased by 4% to $38.8 million from $40.5 million in the same period in 2023[182]
Adaptimmune(ADAP) - 2024 Q2 - Quarterly Results
2024-08-12 11:05
Exhibit 99.1 Adaptimmune Reports Q2 2024 Financial and Business Updates Adaptimmune received U.S. FDA accelerated approval of Tecelra® (afami-cel), the first approved engineered cell therapy for a solid tumor Patients can begin treatment journey; biomarker testing available; Adaptimmune systems ready to receive orders At the end of Q2, Adaptimmune had Total Liquidity 1 of $214.8 million PHILADELPHIA, PA. and OXFORD, UK, August 12, 2024 – Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the ...
Adaptimmune Reports Q2 2024 Financial and Business Updates
Newsfile· 2024-08-12 11:00
Adaptimmune received U.S. FDA accelerated approval of Tecelra® (afami-cel), the first approved engineered cell therapy for a solid tumorPatients can begin treatment journey; biomarker testing available; Adaptimmune systems ready to receive ordersAt the end of Q2, Adaptimmune had Total Liquidity[1] of $214.8 millionPhiladelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - August 12, 2024) - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers ...
Adaptimmune to Report Q2 2024 Financial and Business Updates on Monday, August 12, 2024
Newsfile· 2024-08-05 12:00
Adaptimmune to Report Q2 2024 Financial and Business Updates on Monday, August 12, 2024August 05, 2024 8:00 AM EDT | Source: Adaptimmune Therapeutics PLCPhiladelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - August 5, 2024) - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, will report financial results and provide business updates for the second quarter ended June 30, 2024, before the US markets open on ...
ADAP: Initiating Coverage of Adaptimmune, a Leading T-Cell Therapy Company
Benzinga· 2024-06-17 18:05
Loading...Loading...By Michael KimREAD THE FULL ADAP RESEARCH REPORTWe are initiating coverage of Adaptimmune Therapeutics plc ADAP with a 12-month price target of $3.00, translating into sizeable upside from the stock's current price. Adaptimmune designs, develops, manufactures, and delivers innovative cell therapies via the company's unique T-cell receptor (TCR) platform to treat cancers across multiple solid tumor types.Our investment thesis revolves around:1. Unique T-cell therapy: Adaptimmune's mission ...
Galapagos and Adaptimmune sign clinical collaboration agreement with an option to exclusively license Adaptimmune's TCR T-cell therapy candidate, uza-cel, in head & neck cancer and potential future solid tumor indications
Newsfilter· 2024-05-30 20:01
Adaptimmune and Galapagos to conduct clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next generation MAGE-A4 TCR T-cell therapy) produced on Galapagos' decentralized manufacturing platform in patients with head & neck cancerUza-cel has shown encouraging results in head & neck cancer with partial responses in four out of five patients to date in a Phase 1 trial using Adaptimmune's centralized manufacturing platform Initial in vitro testing of uza-cel produced on Galapagos' dec ...
Adaptimmune(ADAP) - 2024 Q1 - Quarterly Report
2024-05-15 20:05
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37368 ADAPTIMMUNE THERAPEUTICS PLC (Exact name of Registrant as specified in its charter) England and Wales Not Applicabl ...
Adaptimmune(ADAP) - 2024 Q1 - Earnings Call Transcript
2024-05-15 14:07
Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q1 2024 Earnings Conference Call May 15, 2024 8:00 AM ET Company Participants Juli Miller - Investor Relations Adrian Rawcliffe - Chief Executive Officer Gavin Wood - Chief Financial Officer Dennis Williams - Head of Late Stage Development Cintia Piccina - Chief Commercial Officer John Lunger - Chief Patient Supply Officer Elliot Norry - Chief Medical Officer Conference Call Participants Jonathan Chang - Leerink Partners Marc Frahm - TD Cowen Tony Butler - Rodman & ...
Adaptimmune(ADAP) - 2024 Q1 - Quarterly Results
2024-05-15 11:39
Exhibit 99.1 Adaptimmune Reports Q1 2024 Financial and Business Updates Afami-cel commercial and regulatory update presented at Company’s Investor Day (replay HERE); FDA review and inspections progressing with PDUFA date of August 4th, 2024 Commercial and manufacturing infrastructure in place to support afami-cel commercial launch upon approval Data from SPEARHEAD-1 pivotal trial with afami-cel published in The Lancet; data from a planned interim analysis of pivotal lete-cel IGNYTE-ESO trial to be presented ...