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Iovance (IOVA) Posts Narrower-Than-Expected Loss in Q2
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Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 47 cents per share in second-quarter 2023, narrower than the Zacks Consensus Estimate of a loss of 81 cents. In the year-ago quarter, the company reported a loss of 63 cents.
During the quarter, the company generated total revenues of $0.2 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 $6 million. In the year-ago quarter, Iovance did not record any revenues.
Shares of Iovance have gained 11.7% in the year-to-date period against the industry’s 12.5% fall.
Image Source: Zacks Investment Research
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. Currently, Proleukin is approved by the FDA for treating two cancer indications in adults — metastatic renal cell carcinoma (mRCC) and metastatic melanoma.
The reported Proleukin sales of $0.2 million also missed our model estimates of $4 million.
Research & development expenses were $86.3 million, up 18% from the year-ago quarter’s levels. The upside was primarily due to increased related personnel costs and facility building costs.
General and administrative expenses declined 17% from the prior-year quarter’s figure to $21.9 million. This downside can be attributed to the capitalization of expenses associated with the Proleukin acquisition upon transaction completion.
The company had $317.3 million in cash, cash equivalents, short-term investments and restricted cash as of Jun 30, 2023, compared with $632.7 million on Mar 31, 2023. This cash balance, combined with the net equity proceeds of $161.4 million raised last month, is expected to fund the company’s current and planned operations until the end of 2024.
Pipeline Updates
This May, the FDA accepted Iovance’s biologics license application (BLA) submission for lead pipeline drug, lifileucel, in melanoma indication. The BLA seeks accelerated approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which progressed on or after prior anti-PD-1/L1 therapy. If approved, lifileucel will be the first FDA-approved individualized, one-time cell therapy for melanoma patients. A final decision is expected before November 2023-end.
Recently, Iovance randomized the first patient in the phase III TILVANCE-301 study, evaluating the combination of lifileucel and Merck’s blockbuster PD-L1 inhibitor, Keytruda, to treat immune checkpoint inhibitor naïve frontline metastatic melanoma. This late-stage study will also serve as a confirmatory study at the time of seeking full approval for the above BLA.
Other than lifileucel, Iovance is evaluating another TIL therapy, LN-145, as a potential treatment for head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) in two separate mid-stage studies, C-145-03 and IOV-LUN-202, respectively.
In a recently held meeting with the FDA, the company received positive feedback on the IOV-LUN-202 study design. Based on this feedback, management believes that the IOV-LUN-202 study can serve as a registrational study that could support accelerated approval for LN-145 in NSCLC indication. Following the feedback, the company conducted a preliminary analysis of the IOV-LUN-202 study which showed that treatment with LN-145 achieved an objective response rate (ORR) of 26.1% with a median duration of response (mDOR) yet to be reached. Based on this encouraging data, management plans to increase the enrolment size in the IOV-LUN-202 study.
Caribou Biosciences’ loss estimates for 2023 have narrowed from $1.88 to $1.63 per share in the past 30 days. During the same period, the loss estimates per share for 2024 have narrowed from $2.47 to $1.72. Year to date, Caribou Biosciences’ stock has risen 4.1%.
Caribou Biosciences beat earnings estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a negative earnings surprise of 1.36%. In the last reported quarter, CRBU delivered an earnings surprise of 4.17%.
In the past 30 days, estimates for J&J’s 2023 earnings per share have increased from $10.66 to $10.74. During the same period, the earnings estimates per share for 2024 have risen from $11.01 to $11.29. Shares of J&J are down 2.0% in the year-to-date period.
Earnings of J&J beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.58%. In the last reported quarter, J&J’s earnings beat estimates by 7.28%.
In the past 30 days, the estimates for Novo Nordisk’s 2023 and 2024 EPS have increased from $5.07 to $5.27 and $5.95 to $6.10, respectively. Shares of Novo Nordisk are up 39.8% in the year-to-date period.
Earnings of Novo Nordisk beat estimates in two of the last four quarters, met the mark on one occasion and missed the mark on another. On average, the company witnessed an average earnings surprise of 0.35%. In the last reported quarter, Novo Nordisk’s earnings met our estimates.
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Iovance (IOVA) Posts Narrower-Than-Expected Loss in Q2
Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 47 cents per share in second-quarter 2023, narrower than the Zacks Consensus Estimate of a loss of 81 cents. In the year-ago quarter, the company reported a loss of 63 cents.
During the quarter, the company generated total revenues of $0.2 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 $6 million. In the year-ago quarter, Iovance did not record any revenues.
Shares of Iovance have gained 11.7% in the year-to-date period against the industry’s 12.5% fall.
Image Source: Zacks Investment Research
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. Currently, Proleukin is approved by the FDA for treating two cancer indications in adults — metastatic renal cell carcinoma (mRCC) and metastatic melanoma.
The reported Proleukin sales of $0.2 million also missed our model estimates of $4 million.
Research & development expenses were $86.3 million, up 18% from the year-ago quarter’s levels. The upside was primarily due to increased related personnel costs and facility building costs.
General and administrative expenses declined 17% from the prior-year quarter’s figure to $21.9 million. This downside can be attributed to the capitalization of expenses associated with the Proleukin acquisition upon transaction completion.
The company had $317.3 million in cash, cash equivalents, short-term investments and restricted cash as of Jun 30, 2023, compared with $632.7 million on Mar 31, 2023. This cash balance, combined with the net equity proceeds of $161.4 million raised last month, is expected to fund the company’s current and planned operations until the end of 2024.
Pipeline Updates
This May, the FDA accepted Iovance’s biologics license application (BLA) submission for lead pipeline drug, lifileucel, in melanoma indication. The BLA seeks accelerated approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which progressed on or after prior anti-PD-1/L1 therapy. If approved, lifileucel will be the first FDA-approved individualized, one-time cell therapy for melanoma patients. A final decision is expected before November 2023-end.
Recently, Iovance randomized the first patient in the phase III TILVANCE-301 study, evaluating the combination of lifileucel and Merck’s blockbuster PD-L1 inhibitor, Keytruda, to treat immune checkpoint inhibitor naïve frontline metastatic melanoma. This late-stage study will also serve as a confirmatory study at the time of seeking full approval for the above BLA.
Other than lifileucel, Iovance is evaluating another TIL therapy, LN-145, as a potential treatment for head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) in two separate mid-stage studies, C-145-03 and IOV-LUN-202, respectively.
In a recently held meeting with the FDA, the company received positive feedback on the IOV-LUN-202 study design. Based on this feedback, management believes that the IOV-LUN-202 study can serve as a registrational study that could support accelerated approval for LN-145 in NSCLC indication. Following the feedback, the company conducted a preliminary analysis of the IOV-LUN-202 study which showed that treatment with LN-145 achieved an objective response rate (ORR) of 26.1% with a median duration of response (mDOR) yet to be reached. Based on this encouraging data, management plans to increase the enrolment size in the IOV-LUN-202 study.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Iovance currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Caribou Biosciences (CRBU - Free Report) , Johnson & Johnson (JNJ - Free Report) and Novo Nordisk (NVO - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Caribou Biosciences’ loss estimates for 2023 have narrowed from $1.88 to $1.63 per share in the past 30 days. During the same period, the loss estimates per share for 2024 have narrowed from $2.47 to $1.72. Year to date, Caribou Biosciences’ stock has risen 4.1%.
Caribou Biosciences beat earnings estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a negative earnings surprise of 1.36%. In the last reported quarter, CRBU delivered an earnings surprise of 4.17%.
In the past 30 days, estimates for J&J’s 2023 earnings per share have increased from $10.66 to $10.74. During the same period, the earnings estimates per share for 2024 have risen from $11.01 to $11.29. Shares of J&J are down 2.0% in the year-to-date period.
Earnings of J&J beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.58%. In the last reported quarter, J&J’s earnings beat estimates by 7.28%.
In the past 30 days, the estimates for Novo Nordisk’s 2023 and 2024 EPS have increased from $5.07 to $5.27 and $5.95 to $6.10, respectively. Shares of Novo Nordisk are up 39.8% in the year-to-date period.
Earnings of Novo Nordisk beat estimates in two of the last four quarters, met the mark on one occasion and missed the mark on another. On average, the company witnessed an average earnings surprise of 0.35%. In the last reported quarter, Novo Nordisk’s earnings met our estimates.