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Xenon (XENE) Q1 Earnings Beat Estimates, Pipeline in Focus
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Xenon Pharmaceuticals Inc. (XENE - Free Report) reported a loss of 62 cents per share in the first quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 69 cents. The company had incurred a loss of 63 cents per share in the year-ago quarter.
In the reported quarter, Xenon did not generate any revenues. Due to the absence of a marketed product, the company only recognizes periodic collaboration revenues in its top line from its ongoing partnership with Neurocrine Biosciences (NBIX - Free Report) for XEN901, now known as NBI-921352. The company did not recognize any revenues in the year-ago quarter as well.
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. Per the terms of the agreement with NBIX, Xenon is eligible to receive certain clinical, regulatory and commercial milestone-based payments, as well as royalties on future sales.
Year to date, shares of XENE have lost 7.8% compared with the industry’s 6.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
In the first quarter of 2024, research and development (R&D) expenses increased 12% to $44.3 million compared with $39.5 million in the year-ago period. The uptick was primarily due to increased expenses related to the company’s current and future developmental program for azetukalner (previously known as XEN1101) to treat epilepsy and other neurological disorder indications.
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 $14.8 million in the reported quarter, up 55% year over year. The significant rise was on the grounds of increased personnel-related costs, higher stock-based compensation expenses andimproved professional and consulting fees.
Xenon had cash, cash equivalents and marketable securities worth $885.4 million as of Mar 31, 2024, compared with $930.9 million as of Dec 31, 2023. The company expects its existing cash, cash equivalents and marketable securities to fundits current operating plans till 2027.
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 azetukalner in late-stage studies 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 azetukalner, 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.
The company is also evaluating azetukalner 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 has completed a phase II proof-of-concept study on azetukalner called X-NOVA for patients with major depressive disorder (MDD).
Last year, 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 azetukalner in 168 patients with moderate to severe MDD.
Based on the success of the mid-stage study, the company met with the FDA during the first quarter and reached alignment regarding the late-stage clinical development program design for azetukalner to treat MDD, which will comprise three phase III clinical studies. Xenon expects to initiate the first phase III study in the second half of 2024.
Furthermore, the company continues to evaluate other potential neuropsychiatric indications for the future development of azetukalner.
In the past 30 days, the Zacks Consensus Estimate for ANI Pharmaceuticals’ 2024 earnings per share has risen from $4.43 to $4.44. Meanwhile, during the same period, the estimate for ANI Pharmaceuticals’ 2025 earnings per share has remained constant at $5.04. Year to date, shares of ANIP have climbed 19.4%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 109.06%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.93. During the same period, the estimate for Annovis’ 2025 loss per share has widened from $2.82 to $2.83. Year to date, shares of ANVS have plunged 67.1%.
ANVS beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.
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Xenon (XENE) Q1 Earnings Beat Estimates, Pipeline in Focus
Xenon Pharmaceuticals Inc. (XENE - Free Report) reported a loss of 62 cents per share in the first quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 69 cents. The company had incurred a loss of 63 cents per share in the year-ago quarter.
In the reported quarter, Xenon did not generate any revenues. Due to the absence of a marketed product, the company only recognizes periodic collaboration revenues in its top line from its ongoing partnership with Neurocrine Biosciences (NBIX - Free Report) for XEN901, now known as NBI-921352. The company did not recognize any revenues in the year-ago quarter as well.
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. Per the terms of the agreement with NBIX, Xenon is eligible to receive certain clinical, regulatory and commercial milestone-based payments, as well as royalties on future sales.
Year to date, shares of XENE have lost 7.8% compared with the industry’s 6.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
In the first quarter of 2024, research and development (R&D) expenses increased 12% to $44.3 million compared with $39.5 million in the year-ago period. The uptick was primarily due to increased expenses related to the company’s current and future developmental program for azetukalner (previously known as XEN1101) to treat epilepsy and other neurological disorder indications.
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 $14.8 million in the reported quarter, up 55% year over year. The significant rise was on the grounds of increased personnel-related costs, higher stock-based compensation expenses andimproved professional and consulting fees.
Xenon had cash, cash equivalents and marketable securities worth $885.4 million as of Mar 31, 2024, compared with $930.9 million as of Dec 31, 2023. The company expects its existing cash, cash equivalents and marketable securities to fundits current operating plans till 2027.
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 azetukalner in late-stage studies 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 azetukalner, 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.
The company is also evaluating azetukalner 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 has completed a phase II proof-of-concept study on azetukalner called X-NOVA for patients with major depressive disorder (MDD).
Last year, 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 azetukalner in 168 patients with moderate to severe MDD.
Based on the success of the mid-stage study, the company met with the FDA during the first quarter and reached alignment regarding the late-stage clinical development program design for azetukalner to treat MDD, which will comprise three phase III clinical studies. Xenon expects to initiate the first phase III study in the second half of 2024.
Furthermore, the company continues to evaluate other potential neuropsychiatric indications for the future development of azetukalner.
Xenon Pharmaceuticals Inc. Price and EPS Surprise
Xenon Pharmaceuticals Inc. price-eps-surprise | Xenon Pharmaceuticals Inc. Quote
Zacks Rank and Stocks to Consider
Xenon currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the drug/biotech industry are ANI Pharmaceuticals (ANIP - Free Report) and Annovis Bio (ANVS - 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 30 days, the Zacks Consensus Estimate for ANI Pharmaceuticals’ 2024 earnings per share has risen from $4.43 to $4.44. Meanwhile, during the same period, the estimate for ANI Pharmaceuticals’ 2025 earnings per share has remained constant at $5.04. Year to date, shares of ANIP have climbed 19.4%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 109.06%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.93. During the same period, the estimate for Annovis’ 2025 loss per share has widened from $2.82 to $2.83. Year to date, shares of ANVS have plunged 67.1%.
ANVS beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.