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Iovance's (IOVA) Q4 Earnings & Sales Fall Short of Estimates
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Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 45 cents per share in fourth-quarter 2023, wider than the Zacks Consensus Estimate of a loss of 44 cents. In the year-ago quarter, the company reported a loss of 64 cents.
During the quarter, the company generated total revenues of $0.5 million — entirely from product sales of its recently-acquired interleukin-2 (IL-2) product Proleukin (aldesleukin). The reported sales missed the Zacks Consensus Estimate of $1.3 million. In the year-ago quarter, Iovance did not record any revenues.
Quarter in Detail
Following the completion of worldwide rights to Proleukin from U.K.-based Clinigen Limited in May 2023, Iovance is now a commercial-stage company. Proleukin is approved by the FDA to treat two cancer indications in adults — metastatic renal cell carcinoma (mRCC) and metastatic melanoma.
The reported Proleukin sales of $0.5 million also missed our model estimates of $2 million.
Shares of Iovance were down 4.2% in after-market trading on Feb 28, likely due to the lower-than-anticipated Proleukin sales. Year to date, the stock has surged 114.4% compared with the industry’s 2.1% rise.
Image Source: Zacks Investment Research
Research & development (R&D) expenses were $87.5 million, up 9% from the year-ago quarter’s levels. The upside was caused by growth of the internal R&D team and increased expenses on the initiation of the phase III TILVANCE-301 study.
Selling, general and administrative expenses (SG&A) rose 13% from the prior-year quarter’s figure to $29.9 million. The upside can be attributed to an increase in headcount and other related costs.
The company had $346.3 million in cash, cash equivalents, short-term investments and restricted cash as of Dec 31, 2023, compared with $427.8 million on Sep 30, 2023. Management expects this cash balance plus anticipated product revenues, combined with net proceeds of around $197.1 million raised via a public offering earlier this month, to fund the company’s current and planned operations into second-half 2025.
Full-Year Results
Iovance generated total revenues worth $1.2 million during the full year 2023. In the year-ago period, it did not generate any revenues.
The company incurred a loss of $1.89 per share for 2023 compared with a loss of $2.49 in the year-ago period.
2024 Guidance
Management expects cash burn for the year to be in the range of $320 million and $340 million, excluding one-time expenses. It also expects to generate significant revenues from Amtagvi and Proleukin product sales, commencing from second-quarter 2024.
Recent Updates
Earlier this month, Iovance received accelerated approval from the FDA for TIL therapy Amtagvi (lifileucel) for the treatment of adult patients with advanced melanoma, which progressed on or after prior anti-PD-1/L1 and targeted therapy. Following the nod, Amtagvi became the first and the only one-time T-cell therapy to be approved by the FDA for treating solid tumor cancer and also the first treatment option in this melanoma indication. A commercial launch is currently underway.
Regulatory applications for Amtagvi in melanoma indication in Europe and Canada are expected to be filed later this year. 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.
Last December, the FDA placed a clinical hold on the phase II IOV-LUN-202 study evaluating the company’s other TIL therapy, LN-145, in non-small cell lung cancer (NSCLC) indication. The hold was placed following a grade 5 (fatal) serious adverse effect, potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen observed in the study. Owing to the clinical hold, the company has decided to pause the enrollment of new patients in this study. This is likely to delay the clinical advancement of LN-145 in the NSCLC indication.
Iovance intends to expand its clinical pipeline with a new TIL therapy program in endometrial cancer indication. In this regard, management remains on track to start a phase I/II study in mismatch repair (MMR) deficient and MMR proficient patient populations in first-half 2024.
Iovance currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Adicet Bio (ACET - Free Report) , ADMA Biologics (ADMA - Free Report) and Puma Biotechnology (PBYI - Free Report) . While Puma Biotechnology sports a Zacks Rank #1 (Strong Buy), Adicet and ADMA carry 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 Puma Biotechnology’s 2024 earnings per share (EPS) have risen from 69 cents to 71 cents. Year to date, shares of PBYI have rallied 52.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on one occasion. Puma delivered a four-quarter average earnings surprise of 76.55%.
In the past 60 days, estimates for Adicet Bio’s 2024 loss per share have improved from $2.11 to $1.81. Year to date, shares of ACET have rallied 23.3%.
Earnings of Adicet Bio beat estimates in two of the trailing four quarters while missing the mark on the other two occasions. On average, Adicet came up with a four-quarter negative earnings surprise of 8.36%.
In the past 60 days, estimates for ADMA Biologics’ 2024 EPS have risen from 18 cents to 22 cents. Year to date, shares of ADMA have risen 19.0%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 63.57%.
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Iovance's (IOVA) Q4 Earnings & Sales Fall Short of Estimates
Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 45 cents per share in fourth-quarter 2023, wider than the Zacks Consensus Estimate of a loss of 44 cents. In the year-ago quarter, the company reported a loss of 64 cents.
During the quarter, the company generated total revenues of $0.5 million — entirely from product sales of its recently-acquired interleukin-2 (IL-2) product Proleukin (aldesleukin). The reported sales missed the Zacks Consensus Estimate of $1.3 million. In the year-ago quarter, Iovance did not record any revenues.
Quarter in Detail
Following the completion of worldwide rights to Proleukin from U.K.-based Clinigen Limited in May 2023, Iovance is now a commercial-stage company. Proleukin is approved by the FDA to treat two cancer indications in adults — metastatic renal cell carcinoma (mRCC) and metastatic melanoma.
The reported Proleukin sales of $0.5 million also missed our model estimates of $2 million.
Shares of Iovance were down 4.2% in after-market trading on Feb 28, likely due to the lower-than-anticipated Proleukin sales. Year to date, the stock has surged 114.4% compared with the industry’s 2.1% rise.
Image Source: Zacks Investment Research
Research & development (R&D) expenses were $87.5 million, up 9% from the year-ago quarter’s levels. The upside was caused by growth of the internal R&D team and increased expenses on the initiation of the phase III TILVANCE-301 study.
Selling, general and administrative expenses (SG&A) rose 13% from the prior-year quarter’s figure to $29.9 million. The upside can be attributed to an increase in headcount and other related costs.
The company had $346.3 million in cash, cash equivalents, short-term investments and restricted cash as of Dec 31, 2023, compared with $427.8 million on Sep 30, 2023. Management expects this cash balance plus anticipated product revenues, combined with net proceeds of around $197.1 million raised via a public offering earlier this month, to fund the company’s current and planned operations into second-half 2025.
Full-Year Results
Iovance generated total revenues worth $1.2 million during the full year 2023. In the year-ago period, it did not generate any revenues.
The company incurred a loss of $1.89 per share for 2023 compared with a loss of $2.49 in the year-ago period.
2024 Guidance
Management expects cash burn for the year to be in the range of $320 million and $340 million, excluding one-time expenses. It also expects to generate significant revenues from Amtagvi and Proleukin product sales, commencing from second-quarter 2024.
Recent Updates
Earlier this month, Iovance received accelerated approval from the FDA for TIL therapy Amtagvi (lifileucel) for the treatment of adult patients with advanced melanoma, which progressed on or after prior anti-PD-1/L1 and targeted therapy. Following the nod, Amtagvi became the first and the only one-time T-cell therapy to be approved by the FDA for treating solid tumor cancer and also the first treatment option in this melanoma indication. A commercial launch is currently underway.
Regulatory applications for Amtagvi in melanoma indication in Europe and Canada are expected to be filed later this year. 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.
Last December, the FDA placed a clinical hold on the phase II IOV-LUN-202 study evaluating the company’s other TIL therapy, LN-145, in non-small cell lung cancer (NSCLC) indication. The hold was placed following a grade 5 (fatal) serious adverse effect, potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen observed in the study. Owing to the clinical hold, the company has decided to pause the enrollment of new patients in this study. This is likely to delay the clinical advancement of LN-145 in the NSCLC indication.
Iovance intends to expand its clinical pipeline with a new TIL therapy program in endometrial cancer indication. In this regard, management remains on track to start a phase I/II study in mismatch repair (MMR) deficient and MMR proficient patient populations in first-half 2024.
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 Adicet Bio (ACET - Free Report) , ADMA Biologics (ADMA - Free Report) and Puma Biotechnology (PBYI - Free Report) . While Puma Biotechnology sports a Zacks Rank #1 (Strong Buy), Adicet and ADMA carry 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 Puma Biotechnology’s 2024 earnings per share (EPS) have risen from 69 cents to 71 cents. Year to date, shares of PBYI have rallied 52.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on one occasion. Puma delivered a four-quarter average earnings surprise of 76.55%.
In the past 60 days, estimates for Adicet Bio’s 2024 loss per share have improved from $2.11 to $1.81. Year to date, shares of ACET have rallied 23.3%.
Earnings of Adicet Bio beat estimates in two of the trailing four quarters while missing the mark on the other two occasions. On average, Adicet came up with a four-quarter negative earnings surprise of 8.36%.
In the past 60 days, estimates for ADMA Biologics’ 2024 EPS have risen from 18 cents to 22 cents. Year to date, shares of ADMA have risen 19.0%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 63.57%.