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Xenon (XENE) Q4 Earnings Top Estimates, Pipeline in Focus
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Xenon Pharmaceuticals (XENE - Free Report) reported a loss of 64 cents per share in the fourth quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of 76 cents. The company had incurred a loss of 57 cents per share in the year-ago quarter.
Xenon did not generate any revenues from its ongoing collaboration with Neurocrine Biosciences for XEN901, now known as NBI-921352, and missed the Zacks Consensus Estimate of $15 million. The company did not recognize any revenue in the year-ago quarter.
NBI-921352 is a selective Nav1.6 sodium channel inhibitor. Neurocrine is currently evaluating NBI-921352 in a phase II study to treat patients aged 2-21 years with SCN8A developmental and epileptic encephalopathy.
In the past year, shares of Xenon have risen 26.3% against the industry’s 4.6% decline.
Image Source: Zacks Investment Research
Quarter in Detail
In the fourth quarter of 2023, research and development (R&D) expenses increased 18% to $41.1 million compared with $34.8 million in the year-ago period. The uptick in the reported figure was primarily due to increased expenses related to the company’s developmental program for XEN1101 to treat certain epilepsy indications and major depressive disorder (MDD).
The increase in R&D expenses was, however, partially offset by a decrease in expenses for the XEN496 clinical development program, which Xenon decided to no longer pursue in early 2023.
General and administrative expenses were $12.6 million in the reported quarter, up 48% year over year. The significant increase was on the grounds of increased personnel-related costs, higher stock-based compensation expenses andincreased professional and consulting fees.
Xenon had cash, cash equivalents and marketable securities worth $930.9 million as of Dec 31, 2023, compared with $639.1 million as of Sep 30, 2023. The increase in the cash balance was primarily the result of the completion of the company’s public equity offering in December 2023. The company expects its existing cash, cash equivalents and marketable securities to fundits current operating plans, including the completion of the XEN1101 phase III epilepsy studies and fully supporting late-stage clinical development of XEN1101 in MDD, in 2027.
2023 Results
For the full year, Xenon did not generate any revenue and missed the Zacks Consensus Estimate of $15 million. The company recorded revenues of $9.4 million in 2022.
Xenon reported a loss per share of $2.73 in 2023, narrower than the Zacks Consensus Estimate of a loss of $2.82. The company recorded a loss of $2.06 per share in 2022.
Pipeline Updates
Xenon has no approved products in its portfolio at the moment. Therefore, pipeline development remains the key focus of the company.
XENE is currently developing XEN1101 in late-stage development for treatingfocal onset seizures (FOS). Under the phase III epilepsy program, two identical phase III studies, X-TOLE2 and X-TOLE3, are evaluating 15 mg or 25 mg doses of XEN1101, administered with food as adjunctive treatment in patients with FOS. Patient enrollment in the X-TOLE2 study is expected to be completed in late 2024 to early 2025.
XENE plans to submit a regulatory application seeking approval for XEN1101 for FOS, contingent upon the successful completion of the X-TOLE2 study.
The company is also evaluating XEN1101 for primary generalized tonic-clonic seizures, in a phase III X-ACKT study, which is intended to support potential regulatory submissions in this additional epilepsy indication.
Xenon is also currently evaluating XEN1101in a phase II proof-of-concept X-NOVA study for patients with MDD.
During the reported quarter, the company reported positive top-line data from the X-NOVA study, which evaluated the clinical efficacy, safety and tolerability of 10 mg and 20 mg of XEN1101 in 168 patients with moderate to severe MDD.
Based on the success of the mid-stage study, the company plans to meet with the FDA in April 2024 to support the initiation of its late-stage XEN1101 clinical program in MDD, which will comprise three phase III clinical studies. Xenon expects to initiate the first phase III study in the second half of 2024.
The company is also currently evaluating other potential indications for the future development of XEN1101.
Xenon Pharmaceuticals Inc. Price, Consensus and EPS Surprise
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 22 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 32 cents. Over the past year, shares of ADMA have jumped 54.6%.
ADMA beat on earnings in three of the trailing four quarters and met in one, delivering an average surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has remained constant at $2.82. During the same period, the estimate for AKRO’s 2024 loss per share has narrowed from $3.34 to $3.33. In the past year, shares of AKRO have lost 42.2%.
AKRO beat on earnings in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 12.20%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $2.29 to $1.81. In the past year, shares of ACET have plunged 69%.
ACET’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.36%.
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Xenon (XENE) Q4 Earnings Top Estimates, Pipeline in Focus
Xenon Pharmaceuticals (XENE - Free Report) reported a loss of 64 cents per share in the fourth quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of 76 cents. The company had incurred a loss of 57 cents per share in the year-ago quarter.
Xenon did not generate any revenues from its ongoing collaboration with Neurocrine Biosciences for XEN901, now known as NBI-921352, and missed the Zacks Consensus Estimate of $15 million. The company did not recognize any revenue in the year-ago quarter.
NBI-921352 is a selective Nav1.6 sodium channel inhibitor. Neurocrine is currently evaluating NBI-921352 in a phase II study to treat patients aged 2-21 years with SCN8A developmental and epileptic encephalopathy.
In the past year, shares of Xenon have risen 26.3% against the industry’s 4.6% decline.
Image Source: Zacks Investment Research
Quarter in Detail
In the fourth quarter of 2023, research and development (R&D) expenses increased 18% to $41.1 million compared with $34.8 million in the year-ago period. The uptick in the reported figure was primarily due to increased expenses related to the company’s developmental program for XEN1101 to treat certain epilepsy indications and major depressive disorder (MDD).
The increase in R&D expenses was, however, partially offset by a decrease in expenses for the XEN496 clinical development program, which Xenon decided to no longer pursue in early 2023.
General and administrative expenses were $12.6 million in the reported quarter, up 48% year over year. The significant increase was on the grounds of increased personnel-related costs, higher stock-based compensation expenses andincreased professional and consulting fees.
Xenon had cash, cash equivalents and marketable securities worth $930.9 million as of Dec 31, 2023, compared with $639.1 million as of Sep 30, 2023. The increase in the cash balance was primarily the result of the completion of the company’s public equity offering in December 2023. The company expects its existing cash, cash equivalents and marketable securities to fundits current operating plans, including the completion of the XEN1101 phase III epilepsy studies and fully supporting late-stage clinical development of XEN1101 in MDD, in 2027.
2023 Results
For the full year, Xenon did not generate any revenue and missed the Zacks Consensus Estimate of $15 million. The company recorded revenues of $9.4 million in 2022.
Xenon reported a loss per share of $2.73 in 2023, narrower than the Zacks Consensus Estimate of a loss of $2.82. The company recorded a loss of $2.06 per share in 2022.
Pipeline Updates
Xenon has no approved products in its portfolio at the moment. Therefore, pipeline development remains the key focus of the company.
XENE is currently developing XEN1101 in late-stage development for treatingfocal onset seizures (FOS). Under the phase III epilepsy program, two identical phase III studies, X-TOLE2 and X-TOLE3, are evaluating 15 mg or 25 mg doses of XEN1101, administered with food as adjunctive treatment in patients with FOS. Patient enrollment in the X-TOLE2 study is expected to be completed in late 2024 to early 2025.
XENE plans to submit a regulatory application seeking approval for XEN1101 for FOS, contingent upon the successful completion of the X-TOLE2 study.
The company is also evaluating XEN1101 for primary generalized tonic-clonic seizures, in a phase III X-ACKT study, which is intended to support potential regulatory submissions in this additional epilepsy indication.
Xenon is also currently evaluating XEN1101in a phase II proof-of-concept X-NOVA study for patients with MDD.
During the reported quarter, the company reported positive top-line data from the X-NOVA study, which evaluated the clinical efficacy, safety and tolerability of 10 mg and 20 mg of XEN1101 in 168 patients with moderate to severe MDD.
Based on the success of the mid-stage study, the company plans to meet with the FDA in April 2024 to support the initiation of its late-stage XEN1101 clinical program in MDD, which will comprise three phase III clinical studies. Xenon expects to initiate the first phase III study in the second half of 2024.
The company is also currently evaluating other potential indications for the future development of XEN1101.
Xenon Pharmaceuticals Inc. Price, Consensus and EPS Surprise
Xenon Pharmaceuticals Inc. price-consensus-eps-surprise-chart | Xenon Pharmaceuticals Inc. Quote
Zacks Rank and Other Stocks to Consider
Xenon currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the drug/biotech industry worth considering are ADMA Biologics (ADMA - Free Report) , Akero Therapeutics (AKRO - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), AKRO and ACET carry a Zacks Rank #2 each at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 22 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 32 cents. Over the past year, shares of ADMA have jumped 54.6%.
ADMA beat on earnings in three of the trailing four quarters and met in one, delivering an average surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has remained constant at $2.82. During the same period, the estimate for AKRO’s 2024 loss per share has narrowed from $3.34 to $3.33. In the past year, shares of AKRO have lost 42.2%.
AKRO beat on earnings in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 12.20%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $2.29 to $1.81. In the past year, shares of ACET have plunged 69%.
ACET’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.36%.