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IOVA Q3 Earnings Beat on Amtagvi Sales and Lower R&D Costs
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Key Takeaways
Iovance reported a Q3 loss of 5 cents per share, beating estimates, while revenues rose 80% to $121.5 million.
Amtagvi sales surged 77% to $102 million, topping estimates and crossing $100 million for the first time.
IOVA's gross margin climbed to 60% as R&D expenses fell 34%, marking a fifth consecutive quarterly decline.
Iovance Biotherapeutics (IOVA - Free Report) incurred a third-quarter 2026 loss of 5 cents per share, narrower than the Zacks Consensus Estimate of a loss of 9 cents. In the year-ago quarter, the company reported a loss of 25 cents.
Revenues increased 80.1% year over year to $121.5 million, topping the Zacks Consensus Estimate of $117.7 million. Robust Amtagvi demand fueled the beat, with quarterly U.S. sales of the melanoma cell therapy surpassing $100 million for the first time.
Shares of Iovance fell 11% on Thursday despite the better-than-expected results. The decline may have partly reflected broader market weakness amid investor uncertainty following the Democrats’ victories in the U.S. midterm elections.
Year to date, the stock has surged roughly 184% compared with the industry’s nearly 12% growth.
Image Source: Zacks Investment Research
IOVA's Amtagvi Sales Top Estimates
Amtagvi, its tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma, recorded approximately $102 million in U.S. sales. The total was up 77% from the year-ago quarter and 12% sequentially, beating both the Zacks Consensus Estimate and our model estimate of $95 million.
Proleukin, the IL-2 therapy used alongside Amtagvi, generated about $20 million globally. Sales were below the $22 million projected by both the consensus estimate and our model but more than doubled sequentially as wholesaler purchasing realigned with Amtagvi demand. Management said Proleukin purchases now broadly track expected patient use.
Iovance Raises Gross Margin as R&D Spending Falls
Iovance's gross margin, excluding depreciation and amortization, climbed to approximately 60% from 56% in the preceding quarter. This marked the second straight quarterly record, supported by higher product volume, manufacturing efficiencies and cost optimization.
Research and development expenses fell 34.4% year over year to $49.3 million, marking a fifth consecutive quarterly decline. Selling, general and administrative costs rose 11.6% year over year to $38.6 million, although they remained broadly steady compared with the previous quarter.
IOVA Reaffirms Its 2026 Revenue Outlook
Iovance reaffirmed its recently updated full-year 2026 revenue guidance of $410 million to $420 million. Revenues totaled $292.2 million during the first nine months, with management expecting additional sequential growth in the fourth quarter.
Management expects gross margin to improve further, excluding occasional one-time items. The company held roughly $382 million in cash, cash equivalents, short-term investments and restricted cash as of Sept. 30, 2026, which it expects to fund operations well into 2029.
Iovance Extends Amtagvi's Commercial Reach
More than 1,000 patients have received commercial Amtagvi since launch. The network exceeds 100 authorized treatment centers across the United States, Canada and Australia, with at least 110 expected to be active by year-end. Community sites account for more than one-third of existing centers.
The manufacturing turnaround is 30 days or less for most lots. Canada and Australia have approved Amtagvi, with reimbursement discussions underway. Iovance anticipates potential approvals in the U.K. and Switzerland in the first quarter of 2027. A Brazilian regulatory filing and a European Union resubmission are planned for 2027.
IOVA Nears Lung Cancer Filing
Iovance continues to advance Amtagvi in non-small cell lung cancer (NSCLC), with encouraging results from the phase II IOV-LUN-202 study. The company recently reported an objective response rate (ORR) of 24.6% among 69 patients with previously treated non-squamous metastatic NSCLC, including two unconfirmed responses. The results compare favorably with the 12.8% response rate reported for the chemotherapy drug docetaxel in a separate study.
Management also highlighted response durability, with approximately half of responding patients still showing responses. The safety profile improved after introducing a reduced-dose lymphodepletion regimen without compromising the observed efficacy. Iovance is completing enrollment in the study's first two cohorts, targeting approximately 80 patients. The company plans to seek expanded approval through a supplemental biologics license application (sBLA) in 2027.
Separately, Iovance identified a biomarker-selected subgroup of patients with lung cancer who achieved a substantially higher ORR of 59.1%. These findings prompted the launch of POSITILITY, a new registrational-intent cohort targeting 80 patients, with enrollment expected to begin in November 2026. The company also plans to initiate OPTILISM in 2027 to evaluate lifileucel in biomarker-selected patients with previously untreated metastatic NSCLC, potentially expanding its use into the frontline setting.
Beyond lung cancer, Iovance is evaluating Amtagvi across separate mid-stage studies for endometrial cancer and soft tissue sarcomas. It intends to submit an sBLA in the endometrial cancer indication in 2028 or 2029.
The company is also evaluating Amtagvi in combination with Merck’s (MRK - Free Report) Keytruda in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will also serve as a confirmatory study for the therapy in the currently approved indication.
Over the past 30 days, earnings per share (EPS) estimates for TG Therapeutics have risen from 92 cents to 94 cents for 2026. Over the same period, estimates for 2027 EPS have increased from $2.65 to $2.66. TGTX’s shares have risen nearly 95% year to date.
TG Therapeutics’ earnings missed estimates in three of the trailing four quarters and beat in the remaining one, with an average surprise of 184.65%.
Over the past 30 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.03 to $1.04 for 2026. Over the same period, estimates for 2027 EPS have risen from $1.16 to $1.19. AMRX’s shares have climbed more than 54% year-to-date.
Amneal Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 27.21%.
View the Zacks #1 Rank List
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IOVA Q3 Earnings Beat on Amtagvi Sales and Lower R&D Costs
Key Takeaways
Iovance Biotherapeutics (IOVA - Free Report) incurred a third-quarter 2026 loss of 5 cents per share, narrower than the Zacks Consensus Estimate of a loss of 9 cents. In the year-ago quarter, the company reported a loss of 25 cents.
Revenues increased 80.1% year over year to $121.5 million, topping the Zacks Consensus Estimate of $117.7 million. Robust Amtagvi demand fueled the beat, with quarterly U.S. sales of the melanoma cell therapy surpassing $100 million for the first time.
Shares of Iovance fell 11% on Thursday despite the better-than-expected results. The decline may have partly reflected broader market weakness amid investor uncertainty following the Democrats’ victories in the U.S. midterm elections.
Year to date, the stock has surged roughly 184% compared with the industry’s nearly 12% growth.
Image Source: Zacks Investment Research
IOVA's Amtagvi Sales Top Estimates
Amtagvi, its tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma, recorded approximately $102 million in U.S. sales. The total was up 77% from the year-ago quarter and 12% sequentially, beating both the Zacks Consensus Estimate and our model estimate of $95 million.
Proleukin, the IL-2 therapy used alongside Amtagvi, generated about $20 million globally. Sales were below the $22 million projected by both the consensus estimate and our model but more than doubled sequentially as wholesaler purchasing realigned with Amtagvi demand. Management said Proleukin purchases now broadly track expected patient use.
Iovance Raises Gross Margin as R&D Spending Falls
Iovance's gross margin, excluding depreciation and amortization, climbed to approximately 60% from 56% in the preceding quarter. This marked the second straight quarterly record, supported by higher product volume, manufacturing efficiencies and cost optimization.
Research and development expenses fell 34.4% year over year to $49.3 million, marking a fifth consecutive quarterly decline. Selling, general and administrative costs rose 11.6% year over year to $38.6 million, although they remained broadly steady compared with the previous quarter.
IOVA Reaffirms Its 2026 Revenue Outlook
Iovance reaffirmed its recently updated full-year 2026 revenue guidance of $410 million to $420 million. Revenues totaled $292.2 million during the first nine months, with management expecting additional sequential growth in the fourth quarter.
Management expects gross margin to improve further, excluding occasional one-time items. The company held roughly $382 million in cash, cash equivalents, short-term investments and restricted cash as of Sept. 30, 2026, which it expects to fund operations well into 2029.
Iovance Extends Amtagvi's Commercial Reach
More than 1,000 patients have received commercial Amtagvi since launch. The network exceeds 100 authorized treatment centers across the United States, Canada and Australia, with at least 110 expected to be active by year-end. Community sites account for more than one-third of existing centers.
The manufacturing turnaround is 30 days or less for most lots. Canada and Australia have approved Amtagvi, with reimbursement discussions underway. Iovance anticipates potential approvals in the U.K. and Switzerland in the first quarter of 2027. A Brazilian regulatory filing and a European Union resubmission are planned for 2027.
IOVA Nears Lung Cancer Filing
Iovance continues to advance Amtagvi in non-small cell lung cancer (NSCLC), with encouraging results from the phase II IOV-LUN-202 study. The company recently reported an objective response rate (ORR) of 24.6% among 69 patients with previously treated non-squamous metastatic NSCLC, including two unconfirmed responses. The results compare favorably with the 12.8% response rate reported for the chemotherapy drug docetaxel in a separate study.
Management also highlighted response durability, with approximately half of responding patients still showing responses. The safety profile improved after introducing a reduced-dose lymphodepletion regimen without compromising the observed efficacy. Iovance is completing enrollment in the study's first two cohorts, targeting approximately 80 patients. The company plans to seek expanded approval through a supplemental biologics license application (sBLA) in 2027.
Separately, Iovance identified a biomarker-selected subgroup of patients with lung cancer who achieved a substantially higher ORR of 59.1%. These findings prompted the launch of POSITILITY, a new registrational-intent cohort targeting 80 patients, with enrollment expected to begin in November 2026. The company also plans to initiate OPTILISM in 2027 to evaluate lifileucel in biomarker-selected patients with previously untreated metastatic NSCLC, potentially expanding its use into the frontline setting.
Beyond lung cancer, Iovance is evaluating Amtagvi across separate mid-stage studies for endometrial cancer and soft tissue sarcomas. It intends to submit an sBLA in the endometrial cancer indication in 2028 or 2029.
The company is also evaluating Amtagvi in combination with Merck’s (MRK - Free Report) Keytruda in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will also serve as a confirmatory study for the therapy in the currently approved indication.
IOVA’s Zacks Rank
Iovance currently carries a Zacks Rank #2 (Buy).
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Other Key Picks Among Biotech Stocks
Some other top-ranked stocks include TG Therapeutics (TGTX - Free Report) and Amneal Pharmaceuticals (AMRX - Free Report) . While TGTX sports a Zacks Rank #1 (Strong Buy), AMRX carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share (EPS) estimates for TG Therapeutics have risen from 92 cents to 94 cents for 2026. Over the same period, estimates for 2027 EPS have increased from $2.65 to $2.66. TGTX’s shares have risen nearly 95% year to date.
TG Therapeutics’ earnings missed estimates in three of the trailing four quarters and beat in the remaining one, with an average surprise of 184.65%.
Over the past 30 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.03 to $1.04 for 2026. Over the same period, estimates for 2027 EPS have risen from $1.16 to $1.19. AMRX’s shares have climbed more than 54% year-to-date.
Amneal Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 27.21%.