Immunomedics, Inc. incurred a loss of 50 cents per share in fourth-quarter 2019, wider than the Zacks Consensus Estimate of a loss of 45 cents but in line with the loss incurred in the year-ago quarter.
Total revenues were $0.3 million in the quarter, including service fee revenues earned related to the Janssen Promotion agreement.
Total costs and expenses were $91.5 million in the fourth quarter compared with $87.4 million a year ago, mainly due to increase in research & development expenses — mostly attributable to activities related to preparations for the approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic triple-negative breast cancer(mTNBC) in the United States — as well as CRL remediation costs.
Shares of Immunomedics have decreased 0.6% in the past year compared with the industry’s 10% decline.
Pipeline Update
The company resubmitted biologics license application (BLA) seeking accelerated approval for sacituzumab govitecan in mTNBC, which was accepted for filing by the FDA with an action date of Jun 2, 2020.
During the quarter, it initiated the phase 3 registrational TROPiCS-02 study of sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HER2) metastatic breast cancer.
The company continues to expand clinical collaborations to move sacituzumab govitecan into earlier lines of therapy in breast cancer, including the combination with Roche Holding AG’s (RHHBY - Free Report) Tecentriq in frontline mTNBC and the German Breast Group’s phase III study in the curative setting of HER2 breast cancer as a single-agent.
The company also initiated the multi-cohort, Trop-2-enriched phase II TROPiCS-03 study of sacituzumab govitecan for patients with metastatic non-small cell lung cancer.
Milestones for 2020
Immunomedicsexpects to report top-line data from the phase III confirmatory ASCENT study at around mid-2020.
It also expects to report top-line data from full cohort of 100 patients with prior platinum-based and immune checkpoint inhibitor therapies from the phase II pivotal TROPHY U-01 study.
The company expects to complete enrollment for the 40-patient cohort of cisplatin-ineligible patients in TROPHY U-01.
Zacks Rank & Other Stocks to Consider
Immunomedics currently has a Zacks Rank #2 (Buy).
Other top-ranked stocks in the biotech sector include Regeneron Pharmaceuticals Inc. (REGN - Free Report) and Agenus Inc. (AGEN - Free Report) . While Regeneron sports a Zacks Rank #1 (Strong Buy), Agenus carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have moved up from $26.76 to $28.31 for 2020 and from $28.61 to $28.93 for 2021 in the past 90 days. The company delivered an average positive earnings surprise of 1.44% in three of the trailing four quarters.
Agenus’ loss per share estimates for 2020 have narrowed from $1.37 to $1.25 in the past 60 days. The company delivered a four-quarter positive earnings surprise of 23.79%, on average.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Immunomedics, Inc. incurred a loss of 50 cents per share in fourth-quarter 2019, wider than the Zacks Consensus Estimate of a loss of 45 cents but in line with the loss incurred in the year-ago quarter.
Total revenues were $0.3 million in the quarter, including service fee revenues earned related to the Janssen Promotion agreement.
Total costs and expenses were $91.5 million in the fourth quarter compared with $87.4 million a year ago, mainly due to increase in research & development expenses — mostly attributable to activities related to preparations for the approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic triple-negative breast cancer(mTNBC) in the United States — as well as CRL remediation costs.
Shares of Immunomedics have decreased 0.6% in the past year compared with the industry’s 10% decline.
Pipeline Update
The company resubmitted biologics license application (BLA) seeking accelerated approval for sacituzumab govitecan in mTNBC, which was accepted for filing by the FDA with an action date of Jun 2, 2020.
During the quarter, it initiated the phase 3 registrational TROPiCS-02 study of sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HER2) metastatic breast cancer.
The company continues to expand clinical collaborations to move sacituzumab govitecan into earlier lines of therapy in breast cancer, including the combination with Roche Holding AG’s (RHHBY - Free Report) Tecentriq in frontline mTNBC and the German Breast Group’s phase III study in the curative setting of HER2 breast cancer as a single-agent.
The company also initiated the multi-cohort, Trop-2-enriched phase II TROPiCS-03 study of sacituzumab govitecan for patients with metastatic non-small cell lung cancer.
Milestones for 2020
Immunomedicsexpects to report top-line data from the phase III confirmatory ASCENT study at around mid-2020.
It also expects to report top-line data from full cohort of 100 patients with prior platinum-based and immune checkpoint inhibitor therapies from the phase II pivotal TROPHY U-01 study.
The company expects to complete enrollment for the 40-patient cohort of cisplatin-ineligible patients in TROPHY U-01.
Zacks Rank & Other Stocks to Consider
Immunomedics currently has a Zacks Rank #2 (Buy).
Other top-ranked stocks in the biotech sector include Regeneron Pharmaceuticals Inc. (REGN - Free Report) and Agenus Inc. (AGEN - Free Report) . While Regeneron sports a Zacks Rank #1 (Strong Buy), Agenus carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have moved up from $26.76 to $28.31 for 2020 and from $28.61 to $28.93 for 2021 in the past 90 days. The company delivered an average positive earnings surprise of 1.44% in three of the trailing four quarters.
Agenus’ loss per share estimates for 2020 have narrowed from $1.37 to $1.25 in the past 60 days. The company delivered a four-quarter positive earnings surprise of 23.79%, on average.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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