Prothena (PRTA) Q4 Earnings Miss Estimates on Higher R&D Expense
Prothena Corporation PRTA reported fourth-quarter 2023 loss of $1.26 per share, wider than the Zacks Consensus Estimate of a loss of $1.23. The loss in the reported quarter compares unfavorably to earnings of 12 cents per share in the year-ago quarter, wherein the company recorded higher revenues and lower expenses.
Total revenues were $0.3 million in the fourth quarter, which missed the Zacks Consensus Estimate of $1 million. The revenues generated were only collaboration revenues from Bristol-Myers Squibb BMY. In the year-ago quarter, the company recorded total revenues of $49.9 million, of which collaboration revenues from BMY were $9.9 million and milestone payment from Novo Nordisk NVO related to the continued advancement of NNC6019 (formerly PRX004) in a phase II study for the treatment of ATTR cardiomyopathy was $40.0 million.
The company’s shares have lost 50.8% in the past six months against the industry’s growth of 1.9%.
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Quarter in Detail
Collaboration revenues also missed our model estimate of $1 million.
Research and development (R&D) expenses totaled $61.9 million, up 67.8% year over year, primarily due to higher clinical trial expenses, higher personnel-related expenses, and higher consulting and other R&D expenses.
General and administrative expenses amounted to $16.9 million, up from $13 million in the year-ago quarter, primarily due to higher personnel-related and consulting expenses.
As of Dec 31, 2023, Prothena had $620.2 million of cash and equivalents, down from $671.3 million as of Sep 30, 2023. It had no debt as of the same date.
Prothena Corporation plc Price, Consensus and EPS Surprise
Prothena Corporation plc price-consensus-eps-surprise-chart | Prothena Corporation plc Quote
2023 Results
Revenues in 2023 totaled $91.4 million, up from $53.9 million in 2022. The figure, however, missed the Zacks Consensus Estimate of $91.7 million. The company reported loss per share of $2.76 compared with loss per share of $2.47 in 2022. The figure was also wider than the Zacks Consensus Estimate of a loss of $2.73.
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. It is the first program to advance to the clinical-stage from this collaboration.
In July, BMY exercised an option to obtain exclusive worldwide commercial rights for BMS-986446. Under the terms of the deal, BMY paid $55 million to Prothena for the license. BMY is responsible for the future development, manufacturing and commercialization of the candidate. BMY reported that phase I data supports moving BMS-986446 into a phase II study in the first half of 2024.
The company 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. A phase I timeline update is expected in 2024.
The company is evaluating prasinezumab in collaboration with Roche RHHBY for the treatment of Parkinson’s disease (PD). In the first quarter, Roche completed the enrollment for the phase IIb PADOVA study in patients with early PD (NCT04777331) and top-line data from the same is expected in 2024.
Prothena is also evaluating birtamimab, a potential treatment for AL amyloidosis. In 2021, it 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 acquired Prothena’s clinical-stage antibody, NNC6019, a potential first-in-class amyloid depleter antibody for the treatment of ATTR cardiomyopathy. The study is fully recruited, and top-line data from the same is expected in the first half of 2025.
2024 Guidance
The company expects its 2023 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.
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