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Kodiak's (KOD) Q1 Earnings Miss, Pipeline in Focus, Stock Up
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Kodiak Sciences (KOD - Free Report) reported first-quarter 2023 loss per share of $1.35, wider than the Zacks Consensus Estimate of a loss of $1.28. The company reported a loss of $1.83 per share in the year-ago quarter.
The company currently does not have any approved products in its portfolio. As a result, it is yet to generate revenues.
Despite missing earnings estimate, shares of Kodiak jumped 12.6% on Monday due to strong pipeline progress. Kodiak expects to file a single biological license application (BLA) for tarcocimab in the four major retinal vascular disease indications. In the past year, shares of KOD have plunged 13.7% compared with the industry’s 6.1% fall.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses were approximately $56.5 million in the reported quarter, down about 26% year over year. The decrease was due to the maturation of the company’s tarcocimab clinical program and the timing of manufacturing activities.
General and administrative expenses were $18.1 million, down about 8% on a year-over-year basis, primarily due to lower non-cash stock-based compensation expenses.
As of Mar 31, 2023, Kodiak Sciences had cash, cash equivalents and marketable securities worth $421.2 million compared with $478.9 million as of Dec 31, 2023.
Business Updates
KOD is evaluating tarcocimab in several phase III studies for several retinal diseases. The GLEAM and GLIMMER phase III studies are evaluating tarcocimab for six-month durability in patients with diabetic macular edema (DME). The GLOW phase III study is evaluating tarcocimab in non-proliferative diabetic retinopathy (DR) without DME.
The BEACON phase III study, evaluating tarcocimab’s durability, efficacy and safety in retinal vein occlusion (RVO), met its primary endpoint in 2022, Lastly, the DAYLIGHT phase III study is evaluating tarcocimab in wet age-related macular degeneration (wet AMD). The company expects to announce top-line data from all four of these ongoing studies in the third quarter of 2023. The GLEAM, GLIMMER and DAYLIGHT study results are expected in July and the GLOW study result is expected in September.
Subject to the success of these studies, Kodiak Sciences plans to file a single BLA for tarcocimab to treat wet AMD, DME, DR and RVO, with the potential for flexible dosing regimens from every month to every six months. Data from all these studies are expected to be included in the initial BLA for tarcocimab.
Kodiak Sciences is also developing KSI-501, a dual inhibitor Trap-Antibody-Fusion bioconjugate molecule, to treat concurrent inflammation and abnormal angiogenesis observed in the pathogenesis of retinal vascular diseases.
During the quarter, the company reported commencing the dosing of patients in the phase I multiple ascending dose study of KSI-501. Currently, the company is only enrolling patients with DME. The primary objectives of the phase I study include, evaluating ocular and systemic safety, establishing a maximum tolerated dose and exploring the bioactivity of KSI-501.
Kodiak Sciences Inc. Price, Consensus and EPS Surprise
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.83 to $2.31. In the past year, shares of Allogene Therapeutics have fallen by 11.3%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Therapeutics’ 2023 loss per share has narrowed from 62 cents to 43 cents. In the past year, shares of Anixa Therapeutics have increased by 1.8%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 24.04%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 11 cents. In the past year, shares of ADMA Biologics have increased by 107.4%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
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Kodiak's (KOD) Q1 Earnings Miss, Pipeline in Focus, Stock Up
Kodiak Sciences (KOD - Free Report) reported first-quarter 2023 loss per share of $1.35, wider than the Zacks Consensus Estimate of a loss of $1.28. The company reported a loss of $1.83 per share in the year-ago quarter.
The company currently does not have any approved products in its portfolio. As a result, it is yet to generate revenues.
Despite missing earnings estimate, shares of Kodiak jumped 12.6% on Monday due to strong pipeline progress. Kodiak expects to file a single biological license application (BLA) for tarcocimab in the four major retinal vascular disease indications. In the past year, shares of KOD have plunged 13.7% compared with the industry’s 6.1% fall.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses were approximately $56.5 million in the reported quarter, down about 26% year over year. The decrease was due to the maturation of the company’s tarcocimab clinical program and the timing of manufacturing activities.
General and administrative expenses were $18.1 million, down about 8% on a year-over-year basis, primarily due to lower non-cash stock-based compensation expenses.
As of Mar 31, 2023, Kodiak Sciences had cash, cash equivalents and marketable securities worth $421.2 million compared with $478.9 million as of Dec 31, 2023.
Business Updates
KOD is evaluating tarcocimab in several phase III studies for several retinal diseases. The GLEAM and GLIMMER phase III studies are evaluating tarcocimab for six-month durability in patients with diabetic macular edema (DME). The GLOW phase III study is evaluating tarcocimab in non-proliferative diabetic retinopathy (DR) without DME.
The BEACON phase III study, evaluating tarcocimab’s durability, efficacy and safety in retinal vein occlusion (RVO), met its primary endpoint in 2022, Lastly, the DAYLIGHT phase III study is evaluating tarcocimab in wet age-related macular degeneration (wet AMD). The company expects to announce top-line data from all four of these ongoing studies in the third quarter of 2023. The GLEAM, GLIMMER and DAYLIGHT study results are expected in July and the GLOW study result is expected in September.
Subject to the success of these studies, Kodiak Sciences plans to file a single BLA for tarcocimab to treat wet AMD, DME, DR and RVO, with the potential for flexible dosing regimens from every month to every six months. Data from all these studies are expected to be included in the initial BLA for tarcocimab.
Kodiak Sciences is also developing KSI-501, a dual inhibitor Trap-Antibody-Fusion bioconjugate molecule, to treat concurrent inflammation and abnormal angiogenesis observed in the pathogenesis of retinal vascular diseases.
During the quarter, the company reported commencing the dosing of patients in the phase I multiple ascending dose study of KSI-501. Currently, the company is only enrolling patients with DME. The primary objectives of the phase I study include, evaluating ocular and systemic safety, establishing a maximum tolerated dose and exploring the bioactivity of KSI-501.
Kodiak Sciences Inc. Price, Consensus and EPS Surprise
Kodiak Sciences Inc. price-consensus-eps-surprise-chart | Kodiak Sciences Inc. Quote
Zacks Rank and Stocks to Consider
Kodiak currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics (ALLO - Free Report) , Anixa Biosciences (ANIX - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) , all 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 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.83 to $2.31. In the past year, shares of Allogene Therapeutics have fallen by 11.3%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Therapeutics’ 2023 loss per share has narrowed from 62 cents to 43 cents. In the past year, shares of Anixa Therapeutics have increased by 1.8%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 24.04%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 11 cents. In the past year, shares of ADMA Biologics have increased by 107.4%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.