We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Iovance (IOVA) Q1 Earnings Surpass, Sales Lag Estimates
Read MoreHide Full Article
Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 42 cents per share in first-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 45 cents. In the year-ago quarter, the company reported a loss of 50 cents.
During the quarter, the company generated total revenues of $0.7 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 $2.9 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. The FDA approved Proleukin to treat two cancer indications in adults — metastatic renal cell carcinoma (mRCC) and metastatic melanoma.
The reported Proleukin sales of $0.7 million also missed our model estimates of $3 million.
Research & development (R&D) expenses were $79.8 million, down 4% from the year-ago quarter’s levels. The downside was primarily caused by the transition to commercial Amtagvi manufacturing during the quarter.
Selling, general and administrative expenses (SG&A) rose 12% from the prior-year quarter’s figure to $31.4 million. The upside can be attributed to an increase in headcount and other related costs.
The company had $362.6 million in cash, cash equivalents, short-term investments and restricted cash as of Mar 31, 2024, compared with $346.3 million on Dec 31, 2023. This rise in cash balance is due to the closing of public offering in February where IOVA raised net proceeds of around $197 million. Management expects this cash balance, plus anticipated product revenues, to fund the company’s current and planned operations into second-half 2025.
2024 Guidance
Management expects cash burn for the year to be in the range of $320-$340 million, excluding one-time expenses. It also expects to generate significant revenues from Amtagvi sales, commencing from second-half 2024.
Recent Updates
In February, 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 is the first and the only one-time T-cell therapy to be approved by the FDA for a solid tumor cancer and also the first treatment option in this melanoma indication. The drug has also been added as a preferred second-line or subsequent therapy in the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of cutaneous melanoma.
During the quarter, Iovance did not generate any revenues from Amtagvi sales. While the commercial launch is still underway, the company did provide an update on the patient demand for the drug. Iovance stated that more than 100 patients have enrolled for Amtagvi across more than 40 authorized treatment centers (ATCs).
Management also claimed that it has experienced demand for the therapy growing every month since approval. In fact, it expects this demand to increase further throughout the year, driven by patient enrollments. During the conference call, CEO Fred Vogt mentioned that more than 60 additional patients have been identified at ATCs and are expected to enroll soon.
Iovance only had 30 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 is on track to onboard nearly 50 ATCs by this month’s end, it expects to close the year with at least 70 ATCs.
Iovance’s shares were up 6% in after-market trading on Thursday, likely driven by these encouraging commercial updates for Amtagvi. Year to date, the stock has surged 65.4% against the industry’s 6.3% fall.
Image Source: Zacks Investment Research
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.
Management is also on track to start a mid-stage study evaluating Amtagvi in advanced endometrial cancer patients in second-quarter 2024. The drug is already being evaluated in the phase II C-145-04 study in cervical cancer indication.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.40 to $4.44. During the same period, EPS estimates for 2025 have improved from $5.01 to $5.04. Year to date, shares of ANIP have rallied 19.5%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2024 earnings per share (EPS) have risen from $4.42 to $4.56. During the same period, EPS estimates for 2025 have improved from $5.11 to $5.27. Year to date, LGND’s shares have risen 20.6%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the last four quarters. Ligand delivered a four-quarter average earnings surprise of 56.02%.
In the past 60 days, estimates for United Therapeutics’ 2024 EPS have improved from $23.15 to $24.20. During the same period, EPS estimates for 2025 have risen from $24.12 to $26.74. Year to date, shares of UTHR have inched up 21.0%.
Earnings of United Therapeutics beat estimates in each of the last four quarters. UTHR delivered a four-quarter average earnings surprise of 12.41%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Iovance (IOVA) Q1 Earnings Surpass, Sales Lag Estimates
Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 42 cents per share in first-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 45 cents. In the year-ago quarter, the company reported a loss of 50 cents.
During the quarter, the company generated total revenues of $0.7 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 $2.9 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. The FDA approved Proleukin to treat two cancer indications in adults — metastatic renal cell carcinoma (mRCC) and metastatic melanoma.
The reported Proleukin sales of $0.7 million also missed our model estimates of $3 million.
Research & development (R&D) expenses were $79.8 million, down 4% from the year-ago quarter’s levels. The downside was primarily caused by the transition to commercial Amtagvi manufacturing during the quarter.
Selling, general and administrative expenses (SG&A) rose 12% from the prior-year quarter’s figure to $31.4 million. The upside can be attributed to an increase in headcount and other related costs.
The company had $362.6 million in cash, cash equivalents, short-term investments and restricted cash as of Mar 31, 2024, compared with $346.3 million on Dec 31, 2023. This rise in cash balance is due to the closing of public offering in February where IOVA raised net proceeds of around $197 million. Management expects this cash balance, plus anticipated product revenues, to fund the company’s current and planned operations into second-half 2025.
2024 Guidance
Management expects cash burn for the year to be in the range of $320-$340 million, excluding one-time expenses. It also expects to generate significant revenues from Amtagvi sales, commencing from second-half 2024.
Recent Updates
In February, 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 is the first and the only one-time T-cell therapy to be approved by the FDA for a solid tumor cancer and also the first treatment option in this melanoma indication. The drug has also been added as a preferred second-line or subsequent therapy in the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of cutaneous melanoma.
During the quarter, Iovance did not generate any revenues from Amtagvi sales. While the commercial launch is still underway, the company did provide an update on the patient demand for the drug. Iovance stated that more than 100 patients have enrolled for Amtagvi across more than 40 authorized treatment centers (ATCs).
Management also claimed that it has experienced demand for the therapy growing every month since approval. In fact, it expects this demand to increase further throughout the year, driven by patient enrollments. During the conference call, CEO Fred Vogt mentioned that more than 60 additional patients have been identified at ATCs and are expected to enroll soon.
Iovance only had 30 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 is on track to onboard nearly 50 ATCs by this month’s end, it expects to close the year with at least 70 ATCs.
Iovance’s shares were up 6% in after-market trading on Thursday, likely driven by these encouraging commercial updates for Amtagvi. Year to date, the stock has surged 65.4% against the industry’s 6.3% fall.
Image Source: Zacks Investment Research
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.
Management is also on track to start a mid-stage study evaluating Amtagvi in advanced endometrial cancer patients in second-quarter 2024. The drug is already being evaluated in the phase II C-145-04 study in cervical cancer indication.
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 ANI Pharmaceuticals (ANIP - Free Report) , Ligand Pharmaceuticals (LGND - Free Report) and United Therapeutics (UTHR - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.40 to $4.44. During the same period, EPS estimates for 2025 have improved from $5.01 to $5.04. Year to date, shares of ANIP have rallied 19.5%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2024 earnings per share (EPS) have risen from $4.42 to $4.56. During the same period, EPS estimates for 2025 have improved from $5.11 to $5.27. Year to date, LGND’s shares have risen 20.6%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the last four quarters. Ligand delivered a four-quarter average earnings surprise of 56.02%.
In the past 60 days, estimates for United Therapeutics’ 2024 EPS have improved from $23.15 to $24.20. During the same period, EPS estimates for 2025 have risen from $24.12 to $26.74. Year to date, shares of UTHR have inched up 21.0%.
Earnings of United Therapeutics beat estimates in each of the last four quarters. UTHR delivered a four-quarter average earnings surprise of 12.41%.