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.
Immunomedics (IMMU) Q1 Earnings Beat, Trodelvy in Focus
Read MoreHide Full Article
Immunomedics, Inc. incurred a loss of 44 cents per share in first-quarter 2020, narrower than the Zacks Consensus Estimate of a loss of 47 cents and 46 cents in the year-ago quarter.
The company did not earn any revenues in the quarter.
Total costs and expenses were $82 million in the reported quarter compared with $79.6 million a year ago, mainly due to an increase in research & development and sales & marketing expenses.
In late April, Trodelvy (sacituzumab govitecan-hziy) obtained accelerated approval from the FDA for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC), who have received at least two prior therapies for metastatic disease. Trodelvy is the first antibody-drug conjugate (ADC) approved by the FDA specifically for previously-treated mTNBC and also the first FDA-approved anti-Trop-2 ADC.
The commercial launch of the drug is underway, with the first patient treated within days of FDA approval and a National Drug Rebate Agreement with The Centers for Medicare & Medicaid Services fully executed.
As of Mar 31, Immunomedics had $540.6 million in cash, cash equivalents and marketable securities. It recently closed its previously-announced underwritten public offering of common stock with net proceeds of approximately $464.6 million. Per the company, it has the financial ability to launch Trodelvy in the United States for mTNBC.
Shares of Immunomedics have surged 52.2% in the year so far compared with the industry’s 3.7% growth.
Pipeline Update
Based on the unanimous recommendation by the independent Data Safety Monitoring Committee during its recent routine review of the study, the phase III confirmatory ASCENT study of Trodelvy in third-line mTNBC was halted early due to compelling evidence of efficacy across multiple endpoints. Top-line data are expected around mid-2020.
Immunomedics has collaborated with the Dana-Farber Cancer Institute to conduct two phase II studies to evaluate the safety and efficacy of combining Trodelvy with Merck’s (MRK - Free Report) anti-programmed cell death protein 1 (PD-1) antibody, Keytruda (pembrolizumab), in patients with mTNBC and hormone receptor positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC).
Meanwhile, due to the coronavirus pandemic, Immunomedics proactively suspended activation of new study sites and slowed the enrollment of new patients for certain clinical studies.
Our Take
The approval of Trodelvy should provide a significant boost to the company as it had no approved products in its portfolio. The successful commercialization of the drug will be the key to growth.
However, the pandemic might affect the initial uptake of the drug. Moreover, competition remains stiff in the breast cancer space from bigwigs like Roche (RHHBY - Free Report) and Novartis (NVS - Free Report) .
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.
Image: Bigstock
Immunomedics (IMMU) Q1 Earnings Beat, Trodelvy in Focus
Immunomedics, Inc. incurred a loss of 44 cents per share in first-quarter 2020, narrower than the Zacks Consensus Estimate of a loss of 47 cents and 46 cents in the year-ago quarter.
The company did not earn any revenues in the quarter.
Total costs and expenses were $82 million in the reported quarter compared with $79.6 million a year ago, mainly due to an increase in research & development and sales & marketing expenses.
In late April, Trodelvy (sacituzumab govitecan-hziy) obtained accelerated approval from the FDA for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC), who have received at least two prior therapies for metastatic disease. Trodelvy is the first antibody-drug conjugate (ADC) approved by the FDA specifically for previously-treated mTNBC and also the first FDA-approved anti-Trop-2 ADC.
The commercial launch of the drug is underway, with the first patient treated within days of FDA approval and a National Drug Rebate Agreement with The Centers for Medicare & Medicaid Services fully executed.
As of Mar 31, Immunomedics had $540.6 million in cash, cash equivalents and marketable securities. It recently closed its previously-announced underwritten public offering of common stock with net proceeds of approximately $464.6 million. Per the company, it has the financial ability to launch Trodelvy in the United States for mTNBC.
Shares of Immunomedics have surged 52.2% in the year so far compared with the industry’s 3.7% growth.
Pipeline Update
Based on the unanimous recommendation by the independent Data Safety Monitoring Committee during its recent routine review of the study, the phase III confirmatory ASCENT study of Trodelvy in third-line mTNBC was halted early due to compelling evidence of efficacy across multiple endpoints. Top-line data are expected around mid-2020.
Immunomedics has collaborated with the Dana-Farber Cancer Institute to conduct two phase II studies to evaluate the safety and efficacy of combining Trodelvy with Merck’s (MRK - Free Report) anti-programmed cell death protein 1 (PD-1) antibody, Keytruda (pembrolizumab), in patients with mTNBC and hormone receptor positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC).
Meanwhile, due to the coronavirus pandemic, Immunomedics proactively suspended activation of new study sites and slowed the enrollment of new patients for certain clinical studies.
Our Take
The approval of Trodelvy should provide a significant boost to the company as it had no approved products in its portfolio. The successful commercialization of the drug will be the key to growth.
However, the pandemic might affect the initial uptake of the drug. Moreover, competition remains stiff in the breast cancer space from bigwigs like Roche (RHHBY - Free Report) and Novartis (NVS - Free Report) .
Immunomedics currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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 >>