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Iovance Biotherapeutics (2LB) Q3 2026 Earnings Report

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DE:2LB Q3 2026 EPS Results

Actual EPS
-EUR 0.04
Consensus EPS
-EUR 0.08
Beat/Miss
Beat by +EUR 0.03
One Year Ago EPS
-EUR 0.22

DE:2LB Q3 2026 Revenue Results

Actual Revenue
EUR 108.76M
Expected Revenue
EUR 103.85M
Beat/Miss
Beat by +EUR 4.91M
YoY Revenue Growth
+80.07%

Earnings Announcement Details

Quarter
Q3 2026
Date
11/05/2026
Time
Before Open
Conference Call
Thursday, November 5, 2026
DE:2LB Upcoming Earnings

Iovance Biotherapeutics's next earnings date is estimated for March 2, 2027, based on past reporting schedules.

Q3 2026 Earnings Call Audio

DE:2LB Q3 2026 Earnings Call
0:00 / 0:00

Q3 2026 Earnings Slide Deck

No slide deck is available for this earnings event.

Q3 2026 Earnings Call Summary

Q3 2026
Earnings Call Date:Nov 05, 2026|% Change Since:-4.84%|
Earnings Call Sentiment|Positive

The call was strongly positive, supported by record revenue, AMTAGVI adoption, expanding treatment-center access, record margin, an extended cash runway, and encouraging clinical and regulatory progress across multiple pipeline programs. The principal negatives were the continuing operating loss, maturing durability data in lung cancer, and pending international reimbursement and regulatory steps. Overall, highlights significantly outweighed lowlights.

Company Guidance

Iovance reaffirmed full-year 2026 revenue guidance of $410 million-$420 million, expects growth quarter-over-quarter, plans to reach 110 or more authorized treatment centers by year-end, expects margin to expand further over time, and expects cash to fund operations well into 2029; Proleukin’s trend is expected to continue in Q4. The company plans to complete IOV-LUN-202 at 80 patients, submit the lung cancer sBLA in 2027, enroll 80 patients in POSITILITY beginning this month, and plan OPTILISM in 2027; SARATOGA is expected to enroll 40 patients in each cohort, with sBLA submissions planned for 2028 or 2029. Potential approvals in the U.K. and Switzerland are expected by the first quarter of 2027, with a Brazil application and European Union resubmission planned in 2027.

  • Record Quarterly RevenueThird-quarter total revenue reached approximately $122 million, up 80% year over year and 22% sequentially, setting a new quarterly record.
  • AMTAGVI Revenue Surpassed $100 MillionU.S. AMTAGVI revenue was approximately $102 million, increasing 77% year over year and 12% sequentially. AMTAGVI exceeded $100 million in quarterly revenue for the first time.
  • More Than 1,000 Commercial Patients TreatedMore than 1,000 commercial AMTAGVI patients have now been infused in the U.S. since launch, and the company treated more patients in the third quarter than in any prior quarter.
  • Full-Year Revenue Guidance ReaffirmedIovance reaffirmed full-year 2026 revenue guidance of $410 million-$420 million. At the midpoint, this represents nearly 60% growth over last year, and the company reported $292 million of revenue through the first three quarters.
  • Record Gross MarginThird-quarter margin reached approximately 60%, up from the previous sequential record of 56%, marking a new all-time high for the second consecutive quarter. Year-to-date margin was 54%, with AMTAGVI growth, operational efficiencies, and investment discipline cited as contributors.
  • Strong Cash Position and Extended RunwayIovance ended September 30 with approximately $382 million in cash equivalents, short-term investments, and restricted cash. The company expects this cash position to fund operations well into 2029.
  • Proleukin Sales More Than Doubled SequentiallyThird-quarter Proleukin revenue was approximately $20 million, up from $9 million in the second quarter. Management said the increase reflected wholesaler ordering patterns realigning with AMTAGVI demand and represented about 16% of AMTAGVI demand.
  • Revenue Quality and Operating Expense DisciplineGross-to-net deductions remained around 1%, consistent with prior quarters. R&D expenses declined approximately 16% sequentially to about $49 million, marking the fifth consecutive quarter of reduced R&D spending, while SG&A remained flat sequentially at about $39 million despite 22% revenue growth.
  • Expanded Authorized Treatment Center NetworkThe company has more than 100 authorized treatment centers and expects to reach at least 110 by year-end. Community-based centers represent more than one-third of the network, and the time from authorization to first patient treatment continues to shorten.
  • Manufacturing Reliability and Faster TurnaroundFor the majority of manufacturing lots, turnaround time is 30 days or less. Management stated that Iovance has the only scaled, centralized commercial manufacturing process approved by the FDA for TIL therapy and that maintenance is no longer expected to affect earnings going forward.
  • Strong AMTAGVI Physician Adoption DriversMarket research showed that durability of response was rated highly by more than 80% of target physicians and cited by nearly two-thirds as the key driver for choosing AMTAGVI. Management stated that AMTAGVI durability is measured in years, with over three years of median duration.
  • Positive Non-Small Cell Lung Cancer DataIn the IOV-LUN-202 trial, lifileucel produced a 24.6% objective response rate by RECIST 1.1 in 69 previously treated patients, consistent with prior results in 39 patients. Seventeen of 69 patients experienced a partial or complete response, and about half of responders remained ongoing.
  • Reduced-Dose Lymphodepletion Improved SafetyIn IOV-LUN-202, safety improved with the updated reduced-dose lymphodepletion regimen while efficacy, including durability, remained comparable and consistent before and after the regimen change.
  • Planned 2027 Lung Cancer sBLAIovance expects to complete enrollment in IOV-LUN-202 cohorts one and two at approximately 80 patients and plans to submit a supplemental Biologics License Application in 2027. Management reported productive FDA discussions and said it is on track for the planned submission.
  • Precision TIL Strategy in Lung CancerA biomarker-enriched subgroup in IOV-LUN-202 demonstrated a 59.1% response rate, including two ongoing complete responses at 21 and 49 months. The prospectively defined POSITILITY cohort is targeting 80 patients and is expected to begin enrollment this month, while the OPTILISM frontline trial is planned for 2027.
  • Frontline Lung Cancer Biomarker ResultsIn a biomarker-enriched frontline metastatic non-small cell lung cancer subgroup, six of seven patients, or nearly 86%, responded.
  • Positive Soft Tissue Sarcoma ResultsUpdated results in refractory undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma showed a confirmed objective response rate of 55.6%, or five of nine patients. Multiple durable responses were observed, including two ongoing more than a year after infusion.
  • SARATOGA Registrational Trial AdvancingThe SARATOGA registrational trial is actively enrolling in soft tissue sarcoma. The company expects 40 patients in each cohort and has aligned with the FDA on the trial design and a potential accelerated approval pathway, with supplemental BLA submissions planned for 2028 or 2029.
  • Positive Frontline Melanoma DataIn a phase II cohort of frontline advanced melanoma, 62.5% of patients responded, including complete responses in 29.2% of patients. Median overall survival had not been reached after more than four years of follow-up.
  • Phase III Melanoma Trial ExpandingThe TILVANCE-301 phase III trial is enrolling at more than 80 sites and is designed to support a frontline approval and serve as the confirmatory trial for full U.S. approval of AMTAGVI.
  • Endometrial Cancer Pilot ResultsIn the ENDURANCE trial for previously treated metastatic serous endometrial cancer, the first five evaluable patients showed a 40% confirmed objective response rate and a 100% disease control rate. The company plans FDA discussions regarding an expedited approval pathway and expects to increase enrollment.
  • Next-Generation TIL Programs AdvancingThe first-in-human POTENTIL trial of IL-12 tethered TIL therapy IOV-5001 is enrolling patients with metastatic colorectal cancer, triple-negative and estrogen receptor-low breast cancer, and other solid tumors. IOV-4001, a PD-1-inactivated TIL therapy, continues enrolling previously treated metastatic non-small cell lung cancer patients, while a phase I safety cohort is evaluating multiple dose levels of IOV-3001, a second-generation modified IL-2 analog.
  • International Commercial ExpansionAMTAGVI is approved in Canada and Australia for previously treated melanoma, with initial ATCs ready in Canada and onboarding in Australia. The U.K. application is under expedited review, the Swissmedic process is moving smoothly, and potential approvals in both markets are expected by the first quarter of 2027. The company also plans a 2027 application in Brazil and a resubmission in the European Union.
  • New Chief Medical Officer AppointedIovance welcomed Dr. Noah Berkowitz as Chief Medical Officer. Management highlighted his global drug development experience and involvement in approvals for the CAR T-cell therapies Abecma and Breyanzi while at Bristol Myers Squibb.

DE:2LB Earnings History

DE:2LB earnings history
Report DateFiscal QuarterForecast / EPSLast Year's EPSEPS YoY ChangePress Release
Mar 02, 20272026 (Q4)-0.04--0.16――
Nov 05, 20262026 (Q3)-0.08-0.04-0.2280.00% (+0.18)
Aug 06, 20262026 (Q2)-0.12-0.10-0.366.67% (+0.20)
May 07, 20262026 (Q1)-0.14-0.17-0.3247.22% (+0.15)
Feb 24, 20262025 (Q4)-0.16-0.16-0.2330.77% (+0.07)
Nov 06, 20252025 (Q3)-0.23-0.22-0.2510.71% (+0.03)
Aug 07, 20252025 (Q2)-0.25-0.30-0.32.94% (+0.01)
May 08, 20252025 (Q1)-0.22-0.32-0.3814.29% (+0.05)
Feb 27, 20252024 (Q4)-0.24-0.23-0.442.22% (+0.17)
Nov 07, 20242024 (Q3)-0.27-0.25-0.4139.13% (+0.16)

The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.

Beat Missed