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Iovance (IOVA) Q2 Earnings Beat, Stock Up on Upbeat Sales View
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Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 34 cents per share in second-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 37 cents. In the year-ago quarter, the company reported a loss of 47 cents.
During the quarter, the company generated total revenues of $31.1 million — entirely from the product sales of its two marketed drugs. The reported sales beat the Zacks Consensus Estimate of $22.6 million. In the year-ago quarter, Iovance recorded total revenues of $0.2 million.
Quarter in Detail
Iovance currently has two marketed drugs in its portfolio — IL-2 product Proleukin (aldesleukin) and the recently-approved TIL therapy Amtagvi. While Proleukin is approved to treat metastatic renal cell carcinoma (mRCC) and metastatic melanoma in adults, Amtagvi is approved for advanced melanoma indication.
This was the first quarter where the company generated revenues from Amtagvi sales since its approval in February. During the quarter, the drug added $12.8 million to the top line, driven by encouraging patient demand.
Proleukin added $18.3 million during the quarter compared with $0.2 million in the year-ago period. Per management, the surge in sales can be attributed to the drug’s use in the Amtagvi treatment regimen.
Research & development (R&D) expenses were $62.1 million, down 28% from the year-ago quarter’s levels. The downside was primarily caused by the transition to commercial Amtagvi manufacturing during the quarter and the completion of pre-commercial qualification activities in 2023.
Selling, general and administrative expenses (SG&A) surged 80% from the prior-year quarter’s figure to $39.6 million. The upside can be attributed to an increase in headcount and other related costs.
The company had $449.6 million in cash, cash equivalents, short-term investments and restricted cash as of Jul 24, 2024, compared with $362.6 million on Mar 31, 2024. This rise in cash balance is due to the raising of funds of $200 million in net proceeds from an at-the-market (ATM) equity financing facility during the second and third quarters of 2024. Management expects this cash balance, plus anticipated product revenues, to fund the company’s operations into early 2026.
Guidance
Alongside its earnings release, Iovance issued new product revenue guidance for the full years 2024 and 2025.
For the current year, management expects to generate total product revenues in the range of $160-$165 million. This guidance is also higher than the Zacks Consensus Estimate, which is pegged at around $140 million. The newly-issued guidance also includes third-quarter 2024 product revenues that are expected in the range of $53-$55 million.
Management maintained its 2024 guidance for cash burn in the range of $320-$340 million, excluding one-time expenses.
About 2025, management expects to record total product revenues of $450-$475 million. This guidance is significantly higher than the Zacks Consensus Estimate, which is pegged at $375 million. It also expects gross margins to be greater than 70% over the next several years.
Management expects significant quarter-over-quarter growth in sales of both drugs over the next few years, driven by ‘the steepening U.S. adoption curve for Amtagvi.’ Investors were impressed with IOVA’s newly-issued guidance, which beat Wall Street expectations. This was likely the reason for the share price rising 18% in after-market trading on Aug 8, post results announcement and 27% in pre-market trading today.
Year to date, the stock has lost 2.4% compared with the industry’s 6.0% fall.
Image Source: Zacks Investment Research
Recent Updates
In February, Iovance received accelerated approval from the FDA for TIL therapy Amtagvi (lifileucel) for treating adult patients with advanced melanoma, which progressed on or after prior anti-PD-1/L1 and targeted therapy. Following this nod, the drug is the first one-time T-cell therapy to be approved by the agency for a solid tumor cancer and also the first treatment option in this indication.
Iovance only had 30 authorized treatment centers (ATCs) onboard when Amtagvi was approved. Being the key driver of demand and patient enrolments for Amtagvi, management is focused on onboarding more ATCs. While the company has already completed onboarding more than 50 ATCs across 29 states, it expects to close the year with at least 70 ATCs.
Regulatory applications for Amtagvi in melanoma indication have already been submitted in the European Union, with filings for Canada and the U.K. expected before this year’s end. Filings in Australia and additional countries with significant populations of advanced melanoma patients are expected next year.
The company is also evaluating Amtagvi, combined with Merck’s PD-L1 inhibitor, 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 drug in the approved indication. It also plans to start a new cohort in the ongoing mid-stage IOV-COM-202 study to evaluate the combination of Amtagvi and Bristol Myers’ Opdualag (nivolumab and relatlimab) in frontline advanced melanoma.
Management is progressing with label expansion studies for Amtagvi. During the second quarter, management started the phase II IOV-END-201 study evaluating the drug in advanced endometrial cancer indication. Amtagvi is already being evaluated in separate mid-stage studies for cervical cancer and non-small cell lung cancer (NSCLC) indications.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have improved from 14 cents to 13 cents. Estimates for 2025 have improved from $3.44 to $3.21 during the same period. Year to date, shares of Entrada Therapeutics have lost 4.2%.
Earnings of Entrada Therapeutics beat estimates in two of the last four quarters while missing the mark on two other occasions. Entrada delivered a four-quarter average earnings surprise of 42.18%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, shares of Fulcrum Therapeutics have risen 32.5%.
Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum delivered a four-quarter average earnings surprise of 393.18%.
In the past 60 days, the loss per share estimates for Immatics have improved from $1.26 to $1.25 for 2024. During the same period, loss estimates for 2025 have improved from $1.49 to $1.41. Year to date, shares of IMTX have risen 8.3%.
Earnings of Immatics beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 32.57%.
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Iovance (IOVA) Q2 Earnings Beat, Stock Up on Upbeat Sales View
Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 34 cents per share in second-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 37 cents. In the year-ago quarter, the company reported a loss of 47 cents.
During the quarter, the company generated total revenues of $31.1 million — entirely from the product sales of its two marketed drugs. The reported sales beat the Zacks Consensus Estimate of $22.6 million. In the year-ago quarter, Iovance recorded total revenues of $0.2 million.
Quarter in Detail
Iovance currently has two marketed drugs in its portfolio — IL-2 product Proleukin (aldesleukin) and the recently-approved TIL therapy Amtagvi. While Proleukin is approved to treat metastatic renal cell carcinoma (mRCC) and metastatic melanoma in adults, Amtagvi is approved for advanced melanoma indication.
This was the first quarter where the company generated revenues from Amtagvi sales since its approval in February. During the quarter, the drug added $12.8 million to the top line, driven by encouraging patient demand.
Proleukin added $18.3 million during the quarter compared with $0.2 million in the year-ago period. Per management, the surge in sales can be attributed to the drug’s use in the Amtagvi treatment regimen.
Research & development (R&D) expenses were $62.1 million, down 28% from the year-ago quarter’s levels. The downside was primarily caused by the transition to commercial Amtagvi manufacturing during the quarter and the completion of pre-commercial qualification activities in 2023.
Selling, general and administrative expenses (SG&A) surged 80% from the prior-year quarter’s figure to $39.6 million. The upside can be attributed to an increase in headcount and other related costs.
The company had $449.6 million in cash, cash equivalents, short-term investments and restricted cash as of Jul 24, 2024, compared with $362.6 million on Mar 31, 2024. This rise in cash balance is due to the raising of funds of $200 million in net proceeds from an at-the-market (ATM) equity financing facility during the second and third quarters of 2024. Management expects this cash balance, plus anticipated product revenues, to fund the company’s operations into early 2026.
Guidance
Alongside its earnings release, Iovance issued new product revenue guidance for the full years 2024 and 2025.
For the current year, management expects to generate total product revenues in the range of $160-$165 million. This guidance is also higher than the Zacks Consensus Estimate, which is pegged at around $140 million. The newly-issued guidance also includes third-quarter 2024 product revenues that are expected in the range of $53-$55 million.
Management maintained its 2024 guidance for cash burn in the range of $320-$340 million, excluding one-time expenses.
About 2025, management expects to record total product revenues of $450-$475 million. This guidance is significantly higher than the Zacks Consensus Estimate, which is pegged at $375 million. It also expects gross margins to be greater than 70% over the next several years.
Management expects significant quarter-over-quarter growth in sales of both drugs over the next few years, driven by ‘the steepening U.S. adoption curve for Amtagvi.’ Investors were impressed with IOVA’s newly-issued guidance, which beat Wall Street expectations. This was likely the reason for the share price rising 18% in after-market trading on Aug 8, post results announcement and 27% in pre-market trading today.
Year to date, the stock has lost 2.4% compared with the industry’s 6.0% fall.
Image Source: Zacks Investment Research
Recent Updates
In February, Iovance received accelerated approval from the FDA for TIL therapy Amtagvi (lifileucel) for treating adult patients with advanced melanoma, which progressed on or after prior anti-PD-1/L1 and targeted therapy. Following this nod, the drug is the first one-time T-cell therapy to be approved by the agency for a solid tumor cancer and also the first treatment option in this indication.
Iovance only had 30 authorized treatment centers (ATCs) onboard when Amtagvi was approved. Being the key driver of demand and patient enrolments for Amtagvi, management is focused on onboarding more ATCs. While the company has already completed onboarding more than 50 ATCs across 29 states, it expects to close the year with at least 70 ATCs.
Regulatory applications for Amtagvi in melanoma indication have already been submitted in the European Union, with filings for Canada and the U.K. expected before this year’s end. Filings in Australia and additional countries with significant populations of advanced melanoma patients are expected next year.
The company is also evaluating Amtagvi, combined with Merck’s PD-L1 inhibitor, 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 drug in the approved indication. It also plans to start a new cohort in the ongoing mid-stage IOV-COM-202 study to evaluate the combination of Amtagvi and Bristol Myers’ Opdualag (nivolumab and relatlimab) in frontline advanced melanoma.
Management is progressing with label expansion studies for Amtagvi. During the second quarter, management started the phase II IOV-END-201 study evaluating the drug in advanced endometrial cancer indication. Amtagvi is already being evaluated in separate mid-stage studies for cervical cancer and non-small cell lung cancer (NSCLC) indications.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Zacks Rank & Key Picks
Iovance currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Entrada Therapeutics (TRDA - Free Report) , Fulcrum Therapeutics (FULC - Free Report) and Immatics (IMTX - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have improved from 14 cents to 13 cents. Estimates for 2025 have improved from $3.44 to $3.21 during the same period. Year to date, shares of Entrada Therapeutics have lost 4.2%.
Earnings of Entrada Therapeutics beat estimates in two of the last four quarters while missing the mark on two other occasions. Entrada delivered a four-quarter average earnings surprise of 42.18%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, shares of Fulcrum Therapeutics have risen 32.5%.
Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum delivered a four-quarter average earnings surprise of 393.18%.
In the past 60 days, the loss per share estimates for Immatics have improved from $1.26 to $1.25 for 2024. During the same period, loss estimates for 2025 have improved from $1.49 to $1.41. Year to date, shares of IMTX have risen 8.3%.
Earnings of Immatics beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 32.57%.