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Immunovant (IMVT) Up 3% as Q3 Earnings Top, Pipeline in Focus
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Immunovant, Inc. (IMVT - Free Report) reported fiscal third-quarter 2024 net loss of 36 cents per share, narrower than the Zacks Consensus Estimate of a loss of 44 cents. The reported figure is also narrower than the year-ago quarter's loss of 49 cents per share.
Currently, Immunovant does not have any approved product in its portfolio. As a result, it is yet to generate revenues.
Quarter in Detail
Research and development (R&D) expenses totaled $48.3 million, up 14.2% from the year-ago quarter’s reported figure. The year-over-year rise can be attributed to increased operational costs and R&D activities for batoclimab and IMVT-1402 programs. The uptick was partially offset by decreased batoclimab program-specific expenses.
General and administrative expenses amounted to $13.2 million, up 11.9% on a year-over-year basis. The rise was primarily due to an increase in personnel-related expenses, legal and other professional fees, market research and information technology costs.
As of Dec 31, 2023, Immunovant had a cash balance of $691 million compared with $269.9 million as of Sep 30, 2023.
The company’s stock rose 3.4% in the last trading session as the investors cheered the better-than-expected fiscal third-quarter financial results. Shares of IMVT have skyrocketed 97.4% in the past year against the industry’s 11.7% decline.
Image Source: Zacks Investment Research
Pipeline Update
Immunovant is developing its lead pipeline candidate, batoclimab, as a subcutaneous injection to treat autoimmune indications, including myasthenia gravis (MG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP) and Graves’ disease (GD). Several mid-late-stage studies are currently ongoing to evaluate batoclimab for these indications.
During the reported quarter, the company announced positive top-line results from the initial cohort of patients in an ongoing 24-week phase II study of batoclimab in patients with GD. Per the data readout, treatment with the candidate observed more than 50% clinically meaningful response rates.
Immunovant expects to report top-line data from the phase III study of batoclimab to treat MG in the second half of calendar 2024. Data readout from the phase III program for TED is expected in the first half of calendar 2025. Initial data from the phase IIb study in CIDP is expected to be reported in the second or third quarter of 2024.
The company is also developing another candidate IMVT-1402, a next-generation FcRn inhibitor,as a subcutaneous injection in an early-stage study for the treatment of immunoglobulin G (IgG)-mediated autoimmune diseases. The phase I study is evaluating the safety, tolerability and pharmacodynamic profiles of subcutaneously administered IMVT-1402.
In November 2023, Immunovant reported positive initial data from the 600 mg MAD portion of the phase I study of IMVT-1402. Per the data readout, treatment with four subcutaneously administered doses of 600 mg IMVT-1402 reduced total IgG levels by a mean of 74%, which is very similar to the 76% IgG reduction after four weekly injections of 680 mg batoclimab. However, no or minimal changes in serum albumin (the main protein of human blood plasma) or LDL-C (bad cholesterol) were observed, consistent with observations in placebo.
In the same earnings press release, the company also stated that it plans to initiate four to five potentially registrational programs for IMVT-1402 over the next fiscal year (by Mar 31, 2025).
Over the next two fiscal years, Immunovant plans to initiate studies in 10 indications for IMVT-1402 (10 indications inclusive of the four to five potentially registrational programs by Mar 31, 2026).
Immunovant, Inc. Price, Consensus and EPS Surprise
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has remained constant at 69 cents. Over the past year, shares of PBYI have gained 46.5%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have jumped 49.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Immunocore’s 2023 loss per share has remained constant at 95 cents. During the same period, the consensus estimate for Immunocore’s 2024 loss per share has remained constant at $1.42. Over the past year, shares of IMCR have risen 13.4%.
IMCR beat estimates in two of the trailing four quarters and missed on the other two occasions. In the last reported quarter, IMCR reported an earnings surprise of 112.5%.
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Immunovant (IMVT) Up 3% as Q3 Earnings Top, Pipeline in Focus
Immunovant, Inc. (IMVT - Free Report) reported fiscal third-quarter 2024 net loss of 36 cents per share, narrower than the Zacks Consensus Estimate of a loss of 44 cents. The reported figure is also narrower than the year-ago quarter's loss of 49 cents per share.
Currently, Immunovant does not have any approved product in its portfolio. As a result, it is yet to generate revenues.
Quarter in Detail
Research and development (R&D) expenses totaled $48.3 million, up 14.2% from the year-ago quarter’s reported figure. The year-over-year rise can be attributed to increased operational costs and R&D activities for batoclimab and IMVT-1402 programs. The uptick was partially offset by decreased batoclimab program-specific expenses.
General and administrative expenses amounted to $13.2 million, up 11.9% on a year-over-year basis. The rise was primarily due to an increase in personnel-related expenses, legal and other professional fees, market research and information technology costs.
As of Dec 31, 2023, Immunovant had a cash balance of $691 million compared with $269.9 million as of Sep 30, 2023.
The company’s stock rose 3.4% in the last trading session as the investors cheered the better-than-expected fiscal third-quarter financial results. Shares of IMVT have skyrocketed 97.4% in the past year against the industry’s 11.7% decline.
Image Source: Zacks Investment Research
Pipeline Update
Immunovant is developing its lead pipeline candidate, batoclimab, as a subcutaneous injection to treat autoimmune indications, including myasthenia gravis (MG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP) and Graves’ disease (GD). Several mid-late-stage studies are currently ongoing to evaluate batoclimab for these indications.
During the reported quarter, the company announced positive top-line results from the initial cohort of patients in an ongoing 24-week phase II study of batoclimab in patients with GD. Per the data readout, treatment with the candidate observed more than 50% clinically meaningful response rates.
Immunovant expects to report top-line data from the phase III study of batoclimab to treat MG in the second half of calendar 2024. Data readout from the phase III program for TED is expected in the first half of calendar 2025. Initial data from the phase IIb study in CIDP is expected to be reported in the second or third quarter of 2024.
The company is also developing another candidate IMVT-1402, a next-generation FcRn inhibitor,as a subcutaneous injection in an early-stage study for the treatment of immunoglobulin G (IgG)-mediated autoimmune diseases. The phase I study is evaluating the safety, tolerability and pharmacodynamic profiles of subcutaneously administered IMVT-1402.
In November 2023, Immunovant reported positive initial data from the 600 mg MAD portion of the phase I study of IMVT-1402. Per the data readout, treatment with four subcutaneously administered doses of 600 mg IMVT-1402 reduced total IgG levels by a mean of 74%, which is very similar to the 76% IgG reduction after four weekly injections of 680 mg batoclimab. However, no or minimal changes in serum albumin (the main protein of human blood plasma) or LDL-C (bad cholesterol) were observed, consistent with observations in placebo.
In the same earnings press release, the company also stated that it plans to initiate four to five potentially registrational programs for IMVT-1402 over the next fiscal year (by Mar 31, 2025).
Over the next two fiscal years, Immunovant plans to initiate studies in 10 indications for IMVT-1402 (10 indications inclusive of the four to five potentially registrational programs by Mar 31, 2026).
Immunovant, Inc. Price, Consensus and EPS Surprise
Immunovant, Inc. price-consensus-eps-surprise-chart | Immunovant, Inc. Quote
Zacks Rank and Stocks to Consider
Immunovant currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the drug/biotech industry are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Immunocore (IMCR - Free Report) . While PBYI & ADMA currently sport a Zacks Rank #1 (Strong Buy), IMCR carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has remained constant at 69 cents. Over the past year, shares of PBYI have gained 46.5%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have jumped 49.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Immunocore’s 2023 loss per share has remained constant at 95 cents. During the same period, the consensus estimate for Immunocore’s 2024 loss per share has remained constant at $1.42. Over the past year, shares of IMCR have risen 13.4%.
IMCR beat estimates in two of the trailing four quarters and missed on the other two occasions. In the last reported quarter, IMCR reported an earnings surprise of 112.5%.