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Prothena (PRTA) Q1 Earnings Miss Estimates on Higher R&D Expenses
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Prothena Corporation (PRTA - Free Report) reported a loss of $1.34 per share in first-quarter 2024, wider than the Zacks Consensus Estimate of a loss of $1.21. The figure was also wider than a loss of 89 cents in the year-ago quarter due to higher expenses and lower revenues.
Total revenues were $0.05 million in the first quarter, missing the Zacks Consensus Estimate of $4 million and declining from $2.2 million in the year-ago quarter.
Total revenues in the first quarter were from license fees recognized under an agreement with Roche (RHHBY - Free Report) . The same in first-quarter 2023 was generated by a collaboration with Bristol Myers Squibb (BMY - Free Report) .
The company’s shares have lost 36.6% year to date compared with the industry’s decline of 5.9%.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development (R&D) expenses surged 43.2% to $64.1 million primarily due to higher clinical trial expenses, higher personnel-related expenses and higher manufacturing expenses.
General and administrative expenses amounted to $17.5 million, up from $13.7 million in the year-ago quarter, primarily due to higher personnel-related and consulting expenses.
As of March 31, 2024, Prothena had $548.7 million in cash, cash equivalents and restricted cash, and no debt.
Prothena Corporation plc Price, Consensus and EPS Surprise
Prothena is evaluating PRX012 — a wholly-owned investigational next-generation subcutaneous antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) — for treating Alzheimer’s Disease (AD). Initial phase I single ascending dose and multiple ascending dose (MAD) data support once-monthly subcutaneous administration and ongoing evaluation in MAD cohorts. The ongoing phase I study continues as planned by the company, and an update from the same is expected in 2024.
Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications with BMY.
BMS-986446 (formerly PRX005) is designed to be a best-in-class anti-tau, MTBR-specific antibody for the potential treatment of AD.
Bristol Myers Squibb initiated a phase II study on BMS-986446 in approximately 475 patients with early AD. BMY is responsible for all development, manufacturing and commercialization of BMS-986446.
PRX019, a potential treatment of neurodegenerative diseases with an undisclosed target, is also being developed in collaboration with BMY.
PRTA is also developing a dual Aβ-Tau vaccine, PRX123, a potential prevention and treatment for AD. It is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau, designed to promote amyloid clearance and block the transmission of pathogenic tau. An investigational new drug application was cleared by the FDA. The regulatory body granted Fast Track designation to PRX123 for the treatment of AD. A phase I timeline update is expected in 2024.
The company is evaluating prasinezumab in collaboration with Roche for the treatment of Parkinson’s disease (PD).
A phase II study, PASADENA, is being conducted by Roche in patients with early PD. Data from the study showed that patients taking prasinezumab continued to show reduced motor and functional progression compared with real-world data, after four years.
Topline results from phase IIb PADOVA study, which has completed enrollment, is expected in the second half of this year.
Prothena is also evaluating birtamimab, a potential treatment for AL amyloidosis. PRTA reached a Special Protocol Assessment agreement with the FDA and initiated a confirmatory phase III AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis. Top-line results from the study are expected between the fourth quarter of 2024 and the second quarter of 2025.
Novo Nordisk (NVO - Free Report) acquired Prothena’s clinical-stage antibody, NNC6019, a potential first-in-class amyloid depleter antibody for the treatment of ATTR cardiomyopathy. Novo Nordisk is conducting an ongoing phase II study in patients with ATTR cardiomyopathy. The study is fully recruited, and top-line data from the same is expected in the first half of 2025.
2024 Guidance Reiterated
The company expects its 2024 net cash burn from operating and investing activities in the range of $208-$225 million. Prothena expects year-end cash, cash equivalents and restricted cash midpoint to be approximately $405 million. Net loss for 2024 is expected in the band of $229-$255 million.
Image: Bigstock
Prothena (PRTA) Q1 Earnings Miss Estimates on Higher R&D Expenses
Prothena Corporation (PRTA - Free Report) reported a loss of $1.34 per share in first-quarter 2024, wider than the Zacks Consensus Estimate of a loss of $1.21. The figure was also wider than a loss of 89 cents in the year-ago quarter due to higher expenses and lower revenues.
Total revenues were $0.05 million in the first quarter, missing the Zacks Consensus Estimate of $4 million and declining from $2.2 million in the year-ago quarter.
Total revenues in the first quarter were from license fees recognized under an agreement with Roche (RHHBY - Free Report) . The same in first-quarter 2023 was generated by a collaboration with Bristol Myers Squibb (BMY - Free Report) .
The company’s shares have lost 36.6% year to date compared with the industry’s decline of 5.9%.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development (R&D) expenses surged 43.2% to $64.1 million primarily due to higher clinical trial expenses, higher personnel-related expenses and higher manufacturing expenses.
General and administrative expenses amounted to $17.5 million, up from $13.7 million in the year-ago quarter, primarily due to higher personnel-related and consulting expenses.
As of March 31, 2024, Prothena had $548.7 million in cash, cash equivalents and restricted cash, and no debt.
Prothena Corporation plc Price, Consensus and EPS Surprise
Prothena Corporation plc price-consensus-eps-surprise-chart | Prothena Corporation plc Quote
Pipeline Updates
Prothena is evaluating PRX012 — a wholly-owned investigational next-generation subcutaneous antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) — for treating Alzheimer’s Disease (AD). Initial phase I single ascending dose and multiple ascending dose (MAD) data support once-monthly subcutaneous administration and ongoing evaluation in MAD cohorts. The ongoing phase I study continues as planned by the company, and an update from the same is expected in 2024.
Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications with BMY.
BMS-986446 (formerly PRX005) is designed to be a best-in-class anti-tau, MTBR-specific antibody for the potential treatment of AD.
Bristol Myers Squibb initiated a phase II study on BMS-986446 in approximately 475 patients with early AD. BMY is responsible for all development, manufacturing and commercialization of BMS-986446.
PRX019, a potential treatment of neurodegenerative diseases with an undisclosed target, is also being developed in collaboration with BMY.
PRTA is also developing a dual Aβ-Tau vaccine, PRX123, a potential prevention and treatment for AD. It is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau, designed to promote amyloid clearance and block the transmission of pathogenic tau. An investigational new drug application was cleared by the FDA. The regulatory body granted Fast Track designation to PRX123 for the treatment of AD. A phase I timeline update is expected in 2024.
The company is evaluating prasinezumab in collaboration with Roche for the treatment of Parkinson’s disease (PD).
A phase II study, PASADENA, is being conducted by Roche in patients with early PD. Data from the study showed that patients taking prasinezumab continued to show reduced motor and functional progression compared with real-world data, after four years.
Topline results from phase IIb PADOVA study, which has completed enrollment, is expected in the second half of this year.
Prothena is also evaluating birtamimab, a potential treatment for AL amyloidosis. PRTA reached a Special Protocol Assessment agreement with the FDA and initiated a confirmatory phase III AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis. Top-line results from the study are expected between the fourth quarter of 2024 and the second quarter of 2025.
Novo Nordisk (NVO - Free Report) acquired Prothena’s clinical-stage antibody, NNC6019, a potential first-in-class amyloid depleter antibody for the treatment of ATTR cardiomyopathy. Novo Nordisk is conducting an ongoing phase II study in patients with ATTR cardiomyopathy. The study is fully recruited, and top-line data from the same is expected in the first half of 2025.
2024 Guidance Reiterated
The company expects its 2024 net cash burn from operating and investing activities in the range of $208-$225 million. Prothena expects year-end cash, cash equivalents and restricted cash midpoint to be approximately $405 million. Net loss for 2024 is expected in the band of $229-$255 million.
PRTA currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.