Adaptimmune(ADAP) - 2024 Q2 - Quarterly Results

Key Highlights Adaptimmune secured FDA accelerated approval for Tecelra®, its first solid tumor cell therapy, and reported $214.8 million liquidity at Q2 2024 end - Received U.S. FDA accelerated approval for Tecelra® (afami-cel), the first approved engineered T-cell therapy for a solid tumor[1] - The company is prepared for commercial launch, with biomarker testing available and systems ready to receive orders for Tecelra®[1][2] Liquidity Position | Metric | Amount | As of | | :--- | :--- | :--- | | Total Liquidity | $214.8 million | End of Q2 2024 | Business and Pipeline Updates The company focuses on commercializing its Tecelra®-led sarcoma franchise and advancing clinical and preclinical pipelines via strategic collaborations and financing Sarcoma Franchise (Tecelra® and lete-cel) FDA-approved Tecelra® is launching commercially for sarcoma, with a lete-cel BLA planned for 2025, targeting $400 million peak U.S. sales for the franchise - Tecelra® is the first engineered cell therapy approved for solid tumors and the first new treatment for synovial sarcoma in over a decade[2] Tecelra® SPEARHEAD-1 Trial Efficacy | Metric | Result | | :--- | :--- | | Overall Response Rate (ORR) | 43% | | Complete Response Rate | 4.5% | | Median Duration of Response | 6 months | | Patients with ≥12 month response | 39.0% | - Based on successful IGNYTE-ESO trial results (40% ORR), Adaptimmune plans to initiate a rolling Biologics License Application (BLA) for lete-cel in 2025 for MRCLS and synovial sarcoma[3] Clinical Pipeline The clinical pipeline advances with a Galapagos collaboration for uza-cel in head & neck cancer, ongoing SURPASS-3 enrollment for ovarian cancer, and SURPASS Phase 1 trial conclusion - Entered a clinical collaboration with Galapagos to evaluate uza-cel in head & neck cancer using Galapagos' decentralized manufacturing platform[3] - The SURPASS-3 Phase 2 trial investigating uza-cel for platinum-resistant ovarian cancer is currently enrolling patients[3] - Enrollment for the SURPASS Phase 1 trial will cease shortly as screening has stopped[3] Preclinical Pipeline The wholly-owned allogeneic pipeline progresses with process optimization, advancing ADP-600 (PRAME) and ADP-520 (CD70) programs toward IND-enabling activities - The wholly-owned allogeneic pipeline is progressing with continued process optimization[4] - IND-enabling activities are ongoing for the ADP-600 (PRAME) and ADP-520 (CD70) programs[4] Corporate Updates Adaptimmune secured $100 million from a Galapagos collaboration and a $125 million loan facility with Hercules Capital, enhancing financial flexibility for commercial launch and pipeline development - Under the Galapagos agreement, Adaptimmune will receive $100 million in initial payments ($70M upfront, $30M R&D funding), with potential for up to $465 million in milestones plus royalties[5] - Entered into a loan and security agreement with Hercules Capital for up to $125.0 million. Following Tecelra's FDA approval, the company is eligible to draw down a $25.0 million tranche[5] Financial Results Adaptimmune reported a significant Q2 2024 revenue increase to $128.2 million and a $69.5 million net profit, driven by terminated collaboration revenue, ending the quarter with $214.8 million liquidity Financial Performance Summary (Q2 2024) Q2 2024 revenue significantly increased to $128.2 million (from $5.1 million), driven by a $101.3 million Genentech adjustment, resulting in a $69.5 million net profit (vs. $21.3 million net loss in Q2 2023), with R&D expenses rising to $40.4 million Q2 Financial Performance (Three Months Ended June 30, in millions, except per share data) | Metric | Q2 2024 | Q2 2023 | Change | | :--- | :--- | :--- | :--- | | Revenue | $128.2M | $5.1M | +2414% | | R&D Expenses | $40.4M | $30.0M | +34.7% | | G&A Expenses | $19.1M | $20.1M | -5.0% | | Net Profit/(Loss) | $69.5M | $(21.3)M | Profit vs Loss | | EPS (Diluted) | $0.04 | $(0.02) | Profit vs Loss | - The significant increase in revenue in 2024 is primarily due to recognizing the majority of remaining deferred income from the terminated Genentech collaboration, including a $101.3 million cumulative catch-up adjustment[7] - R&D expenses increased due to a higher number of employees, increased subcontracted expenditures, and in-process R&D costs[7] Financial Position and Liquidity As of June 30, 2024, Adaptimmune's total liquidity stood at $214.8 million, a notable increase from $146.9 million at the end of 2023. This non-GAAP measure, comprising cash, cash equivalents, and marketable securities, reflects the company's enhanced capital position to support its operational and commercial activities Total Liquidity (in thousands) | Component | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $211,810 | $143,991 | | Marketable securities | $2,979 | $2,947 | | Total Liquidity | $214,789 | $146,938 | Condensed Consolidated Financial Statements Statement of Operations Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $128,231 | $133,909 | | Total operating expenses | $(59,531) | $(114,470) | | Operating profit/(loss) | $68,700 | $19,439 | | Net profit/(loss) | $69,521 | $21,018 | | Net profit/(loss) per share (Diluted) | $0.04 | $0.01 | Balance Sheet Balance Sheet Highlights (in thousands) | Metric | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $211,810 | $143,991 | | Total current assets | $253,770 | $207,552 | | Total assets | $321,702 | $282,616 | | Total current liabilities | $82,073 | $72,788 | | Total liabilities | $225,428 | $243,103 | | Total stockholders' equity | $96,274 | $39,513 | Cash Flow Statement Cash Flow Highlights (Six Months Ended June 30, in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Net cash provided by/(used in) operating activities | $15,449 | $(81,045) | | Net cash (used in)/provided by investing activities | $(1,101) | $51,035 | | Net cash provided by financing activities | $53,747 | $210 | | Net increase/(decrease) in cash | $67,659 | $(29,402) |