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Kodiak (KOD) Stock Falls on Q4 Earnings Miss, Pipeline in Focus
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Kodiak Sciences Inc. (KOD - Free Report) incurred a loss per share of $1.13 in the fourth quarter of 2023, wider than the Zacks Consensus Estimate of a loss of 86 cents. The company had incurred a loss of $1.35 per share in the year-ago quarter.
Currently, KOD does not have any approved products in its portfolio. As a result, it is yet to generate revenues.
Quarter in Detail
Research and development expenses were approximately $46.6 million in the reported quarter, down about 16.8% year over year. The decrease was due to the reduction in expenses owing to the conclusion of some clinical studies on its lead pipeline candidate, tarcocimab.
General and administrative expenses were $16.7 million, down 7.7% on a year-over-year basis, primarily due to lower non-cash stock-based compensation expenses.
As of Dec 31, 2023, Kodiak had cash, cash equivalents and marketable securities worth $285.5 million compared with $345.7 million as of Sep 30, 2023.
Shares of Kodiak were down 29.4% on Mar 28 following the announcement of the weaker-than-expected earnings. The stock has lost 3.2% in the past year compared with the industry’s decline of 7%.
Image Source: Zacks Investment Research
Pipeline Updates
In November 2023, Kodiak announced positive top-line results from its phase III GLOW1 study evaluating tarcocimab in moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The GLOW study met its primary endpoint and all key secondary endpoints with high statistical significance.
Building on the success of the GLOW1 study, KOD initiated the pivotal phase III GLOW2 study evaluating tarcocimab in diabetic retinopathy, which is actively enrolling patients.
Apart from NPDR, tarcocimab is also being evaluated in the phase III BEACON study in retinal vein occlusion ("RVO"), the phase III DAYLIGHT study in wet age-related macular degeneration ("wet AMD"), the phase III GLEAM and GLIMMER studies with identical study design in diabetic macular edema ("DME") and the phase II/III DAZZLE study in wet AMD.
Apart from the GLOW1 study both the BEACON study and the DAYLIGHT study have met their respective primary endpoints.
The company previously held a meeting with the FDA to discuss the positive results from DAYLIGHT, BEACON and GLOW studies. KOD believes that it has a clear regulatory pathway, requiring one additional positive pivotal study to support a single biologics license application submission for all three indications — wet AMD, RVO and NPDR.
This apart, Kodiak is developing KSI-501, an anti-IL6 and anti-VEGF bispecific biopolymer conjugate, in a phase I study for patients with DME. Data from the study showed that repeated monthly dosing of KSI-501 was safe and well tolerated and achieved clinically meaningful and sustained visual acuity gains in the given patient population, thereby meeting its goal.
The company also plans to advance KSI-501 into a phase III study — DAYBREAK — to evaluate its efficacy, durability and safety in wet AMD later in 2024.
KOD plans to study tarcocimab as a second investigational arm in the DAYBREAK study in wet AMD, with KSI-501 being the first investigational arm.
The study is designed to be a non-inferiority study, evaluating KSI-501 dosed every four to 24 weeks, compared to Regeneron’s Eylea (aflibercept) dosed per label.
Pending discussion with the FDA, the company plans to initiate the DAYBREAK study as soon as regulatory alignment is completed, i.e., by mid-2024.
Kodiak Sciences Inc. Price, Consensus and EPS Surprise
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. In the past year, shares of ADMA have risen 98.8%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. In the past year, shares of VNDA have plunged 39.9%.
VNDA’s earnings beat estimates in each of the trailing three quarters, the average surprise being 92.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. In the past year, shares of ANIP have increased 78.1%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.
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Kodiak (KOD) Stock Falls on Q4 Earnings Miss, Pipeline in Focus
Kodiak Sciences Inc. (KOD - Free Report) incurred a loss per share of $1.13 in the fourth quarter of 2023, wider than the Zacks Consensus Estimate of a loss of 86 cents. The company had incurred a loss of $1.35 per share in the year-ago quarter.
Currently, KOD does not have any approved products in its portfolio. As a result, it is yet to generate revenues.
Quarter in Detail
Research and development expenses were approximately $46.6 million in the reported quarter, down about 16.8% year over year. The decrease was due to the reduction in expenses owing to the conclusion of some clinical studies on its lead pipeline candidate, tarcocimab.
General and administrative expenses were $16.7 million, down 7.7% on a year-over-year basis, primarily due to lower non-cash stock-based compensation expenses.
As of Dec 31, 2023, Kodiak had cash, cash equivalents and marketable securities worth $285.5 million compared with $345.7 million as of Sep 30, 2023.
Shares of Kodiak were down 29.4% on Mar 28 following the announcement of the weaker-than-expected earnings. The stock has lost 3.2% in the past year compared with the industry’s decline of 7%.
Image Source: Zacks Investment Research
Pipeline Updates
In November 2023, Kodiak announced positive top-line results from its phase III GLOW1 study evaluating tarcocimab in moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The GLOW study met its primary endpoint and all key secondary endpoints with high statistical significance.
Building on the success of the GLOW1 study, KOD initiated the pivotal phase III GLOW2 study evaluating tarcocimab in diabetic retinopathy, which is actively enrolling patients.
Apart from NPDR, tarcocimab is also being evaluated in the phase III BEACON study in retinal vein occlusion ("RVO"), the phase III DAYLIGHT study in wet age-related macular degeneration ("wet AMD"), the phase III GLEAM and GLIMMER studies with identical study design in diabetic macular edema ("DME") and the phase II/III DAZZLE study in wet AMD.
Apart from the GLOW1 study both the BEACON study and the DAYLIGHT study have met their respective primary endpoints.
The company previously held a meeting with the FDA to discuss the positive results from DAYLIGHT, BEACON and GLOW studies. KOD believes that it has a clear regulatory pathway, requiring one additional positive pivotal study to support a single biologics license application submission for all three indications — wet AMD, RVO and NPDR.
This apart, Kodiak is developing KSI-501, an anti-IL6 and anti-VEGF bispecific biopolymer conjugate, in a phase I study for patients with DME. Data from the study showed that repeated monthly dosing of KSI-501 was safe and well tolerated and achieved clinically meaningful and sustained visual acuity gains in the given patient population, thereby meeting its goal.
The company also plans to advance KSI-501 into a phase III study — DAYBREAK — to evaluate its efficacy, durability and safety in wet AMD later in 2024.
KOD plans to study tarcocimab as a second investigational arm in the DAYBREAK study in wet AMD, with KSI-501 being the first investigational arm.
The study is designed to be a non-inferiority study, evaluating KSI-501 dosed every four to 24 weeks, compared to Regeneron’s Eylea (aflibercept) dosed per label.
Pending discussion with the FDA, the company plans to initiate the DAYBREAK study as soon as regulatory alignment is completed, i.e., by mid-2024.
Kodiak Sciences Inc. Price, Consensus and EPS Surprise
Kodiak Sciences Inc. price-consensus-eps-surprise-chart | Kodiak Sciences Inc. Quote
Zacks Rank & Other Stocks to Consider
Kodiak currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Vanda Pharmaceuticals Inc. (VNDA - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. In the past year, shares of ADMA have risen 98.8%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. In the past year, shares of VNDA have plunged 39.9%.
VNDA’s earnings beat estimates in each of the trailing three quarters, the average surprise being 92.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. In the past year, shares of ANIP have increased 78.1%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.