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IOVA Posts Narrower-Than-Expected Q3 Loss, Amtagvi Sales Drive Top line
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Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a third-quarter 2024 loss of 28 cents per share, narrower than the Zacks Consensus Estimate of a loss of 31 cents. In the year-ago quarter, the company reported a loss of 46 cents.
During the quarter, the company generated total revenues of $58.6 million, entirely from the product sales of its two marketed drugs. The reported sales beat the Zacks Consensus Estimate of $53.5 million. In the year-ago quarter, Iovance recorded total revenues of $0.5 million.
More on IOVA’s Earnings
Iovance currently has two marketed drugs in its portfolio — the 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 marked the second quarter of recording revenues from Amtagvi sales since its approval in February. Iovance recorded $42.1 million from the drug’s sales during the third quarter compared with $12.8 million in the second, driven by encouraging patient demand. Sales of the drug were in line with our model estimates.
Proleukin added $16.5 million during the quarter compared with $0.5 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. The metric beat our model estimate of $11 million.
Year to date, shares of Iovance have surged 51% against the industry’s 2.4% decline.
Image Source: Zacks Investment Research
IOVA’s Costs & Cash Balance
Research & development (R&D) expenses totaled $68.2 million, down 22% from the year-ago quarter’s level. 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 47% 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.
As of Sept. 30, 2024, the company had nearly $404 million in cash, cash equivalents, short-term investments and restricted cash compared with $419 million as of June 30, 2024. The current cash balance also includes net proceeds of $200 million raised 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.
IOVA Maintains Revenue Guidance
Iovance reiterated its previously issued product revenue guidance for full-year 2024 and 2025.
For the current year, management expects total product revenues to be in the range of $160-$165 million. It also maintained its 2024 projection for cash burn in the range of $320-$340 million, excluding one-time expenses.
In 2025, management expects total product revenues of $450-$475 million and gross margins greater than 70% over the next several years.
Updates on IOVA’s Pipeline & Other News
In February, Iovance received accelerated approval from the FDA for Amtagvi 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 became 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.
When Amtagvi was approved, Iovance only had 30 authorized treatment centers (ATCs) onboard. As the key driver of demand and patient enrolments for Amtagvi, management is focused on onboarding more ATCs. While the company has already completed onboarding at 56 ATCs across 29 states, it expects to close the year with at least 70 ATCs.
Regulatory applications for Amtagvi in melanoma indication are currently under review in the European Union and the U.K., with potential approvals expected next year. Filings in Australia and additional countries with significant populations of advanced melanoma patients are expected next year.
IOVA 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 has also started 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 in multiple cancer indications, including non-small cell lung cancer (NSCLC), cervical cancer and endometrial cancer.
Iovance is accelerating enrolment in the phase II IOV-LUN-202 study, which evaluates Amtagvi in post-anti-PD-1 NSCLC. An update from this study is expected at a medical conference next year. If the study's data is positive, management intends to use it to seek accelerated approval for the drug in the given indication in 2027. Amtagvi is also being evaluated in separate mid-stage studies for cervical and endometrial cancer indications.
In the past 60 days, estimates for Amicus Therapeutics’ 2024 EPS have risen from 20 cents to 22 cents. EPS estimates for 2025 have increased from 49 cents to 53 cents during the same period. Year to date, shares of FOLD have lost 20.8%.
FOLD’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 27.09%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.88. Year to date, shares of Castle Biosciences have surged 51.3%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for Biogen’s 2024 EPS have increased from $16.12 to $16.37. EPS estimates for 2025 have improved from $17.09 to $17.15. Year to date, shares of BIIB have lost 32.6%.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 9.99%.
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IOVA Posts Narrower-Than-Expected Q3 Loss, Amtagvi Sales Drive Top line
Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a third-quarter 2024 loss of 28 cents per share, narrower than the Zacks Consensus Estimate of a loss of 31 cents. In the year-ago quarter, the company reported a loss of 46 cents.
During the quarter, the company generated total revenues of $58.6 million, entirely from the product sales of its two marketed drugs. The reported sales beat the Zacks Consensus Estimate of $53.5 million. In the year-ago quarter, Iovance recorded total revenues of $0.5 million.
More on IOVA’s Earnings
Iovance currently has two marketed drugs in its portfolio — the 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 marked the second quarter of recording revenues from Amtagvi sales since its approval in February. Iovance recorded $42.1 million from the drug’s sales during the third quarter compared with $12.8 million in the second, driven by encouraging patient demand. Sales of the drug were in line with our model estimates.
Proleukin added $16.5 million during the quarter compared with $0.5 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. The metric beat our model estimate of $11 million.
Year to date, shares of Iovance have surged 51% against the industry’s 2.4% decline.
Image Source: Zacks Investment Research
IOVA’s Costs & Cash Balance
Research & development (R&D) expenses totaled $68.2 million, down 22% from the year-ago quarter’s level. 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 47% 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.
As of Sept. 30, 2024, the company had nearly $404 million in cash, cash equivalents, short-term investments and restricted cash compared with $419 million as of June 30, 2024. The current cash balance also includes net proceeds of $200 million raised 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.
IOVA Maintains Revenue Guidance
Iovance reiterated its previously issued product revenue guidance for full-year 2024 and 2025.
For the current year, management expects total product revenues to be in the range of $160-$165 million. It also maintained its 2024 projection for cash burn in the range of $320-$340 million, excluding one-time expenses.
In 2025, management expects total product revenues of $450-$475 million and gross margins greater than 70% over the next several years.
Updates on IOVA’s Pipeline & Other News
In February, Iovance received accelerated approval from the FDA for Amtagvi 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 became 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.
When Amtagvi was approved, Iovance only had 30 authorized treatment centers (ATCs) onboard. As the key driver of demand and patient enrolments for Amtagvi, management is focused on onboarding more ATCs. While the company has already completed onboarding at 56 ATCs across 29 states, it expects to close the year with at least 70 ATCs.
Regulatory applications for Amtagvi in melanoma indication are currently under review in the European Union and the U.K., with potential approvals expected next year. Filings in Australia and additional countries with significant populations of advanced melanoma patients are expected next year.
IOVA 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 has also started 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 in multiple cancer indications, including non-small cell lung cancer (NSCLC), cervical cancer and endometrial cancer.
Iovance is accelerating enrolment in the phase II IOV-LUN-202 study, which evaluates Amtagvi in post-anti-PD-1 NSCLC. An update from this study is expected at a medical conference next year. If the study's data is positive, management intends to use it to seek accelerated approval for the drug in the given indication in 2027. Amtagvi is also being evaluated in separate mid-stage studies for cervical and endometrial cancer indications.
IOVA’s Zacks Rank
Iovance currently has a Zacks Rank #4 (Sell).
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Amicus Therapeutics (FOLD - Free Report) , Castle Biosciences (CSTL - Free Report) and Biogen (BIIB - Free Report) . While FOLD and CSTL currently sport a Zacks Rank #1 (Strong Buy) each, BIIB carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Amicus Therapeutics’ 2024 EPS have risen from 20 cents to 22 cents. EPS estimates for 2025 have increased from 49 cents to 53 cents during the same period. Year to date, shares of FOLD have lost 20.8%.
FOLD’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 27.09%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.88. Year to date, shares of Castle Biosciences have surged 51.3%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for Biogen’s 2024 EPS have increased from $16.12 to $16.37. EPS estimates for 2025 have improved from $17.09 to $17.15. Year to date, shares of BIIB have lost 32.6%.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 9.99%.