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Clinical-stage company Prothena Corporation (PRTA - Free Report) reported third-quarter 2022 loss of 97 cents per share, much wider than the Zacks Consensus Estimate of a loss of 31 cents per share. In the year-ago quarter, the company had reported earnings of $2.13 per share.
The year-over-year decline was due to higher revenues in the year-ago quarter and lower operating expenses.
Total revenues came in at $1.5 million in the quarter, missing the Zacks Consensus Estimate of $27 million and were down from $139.1 million in the year-ago quarter. Revenues in the quarter primarily included collaboration revenues from Bristol Myers Squibb (BMY - Free Report) .
Revenues for the third quarter of 2021 included collaboration revenues of $78.5 million from Bristol Myers for the option exercise and U.S. license for PRX005 and $60.7 million from the sale of the clinical-stage antibody NNC6019 (formerly PRX004) program and related rights to the company’s ATTR amyloidosis business and pipeline to Novo Nordisk (NVO - Free Report) .
The company’s shares have gained 18.1% in the year so far against the industry’s decline of 22.3%.
Image Source: Zacks Investment Research
Quarter in Detail
R&D expenses were $39.9 million, up from $18 million in the year-ago quarter, primarily due to higher manufacturing costs related to the birtamimab, PRX012, PRX019, PRX123 and PRX005 programs; higher personnel-related expenses; higher clinical trial expenses mainly related to the PRX012 and birtamimab programs; increased other R&D expenses and higher consulting expenses.
General and administrative (G&A) expenses were $12 million, roughly flat with the year-ago quarter.
As of Sep 30, 2022, Prothena had $497.0 million in cash, cash equivalents and restricted cash and no debt.
Prothena Corporation plc Price, Consensus and EPS Surprise
Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications with Bristol Myers. PRX005 — a potential treatment for Alzheimer’s disease (AD) — is an investigational antibody that targets tau, a protein implicated in diseases including AD, frontotemporal dementia, progressive supranuclear palsy, chronic traumatic encephalopathy and other tauopathies. A phase I study was initiated in 2021 and top-line data is expected shortly.
Prothena is also evaluating PRX012, an investigational high-potency monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) for treating AD. The FDA granted Fast Track designation to PRX012 for the treatment of AD. A phase I multiple ascending dose study is expected to be initiated by 2022-end and top-line data from the phase I study is expected in 2023.
The company is also developing a dual Aβ-Tau vaccine — a potential prevention and treatment for AD — to target key epitopes within Aβ and tau proteins to promote amyloid clearance and block pathogenic tau interaction. An Investigational New Drug application for the vaccine is anticipated in 2023.
The company is also evaluating prasinezumab in collaboration with Roche (RHHBY - Free Report) for the treatment of Parkinson’s disease. A phase IIb PADOVA study in patients with early Parkinson’s disease is being conducted by Roche and top-line data is expected in 2024.
It is also evaluating birtamimab, a potential treatment for AL amyloidosis. 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 in 2021. Results are expected in 2024.
Novo Nordisk has acquired Prothena’s clinical-stage antibody, PRX004 (now NNC6019) and a broader ATTR amyloidosis program. A phase II study of NNC6019 in patients with ATTR cardiomyopathy is being conducted by Novo Nordisk.
Prothena currently carries a Zacks Rank #5 (Strong Sell).
Image: Bigstock
Prothena's (PRTA) Q3 Earnings Miss, Revenues Decline Y/Y
Clinical-stage company Prothena Corporation (PRTA - Free Report) reported third-quarter 2022 loss of 97 cents per share, much wider than the Zacks Consensus Estimate of a loss of 31 cents per share. In the year-ago quarter, the company had reported earnings of $2.13 per share.
The year-over-year decline was due to higher revenues in the year-ago quarter and lower operating expenses.
Total revenues came in at $1.5 million in the quarter, missing the Zacks Consensus Estimate of $27 million and were down from $139.1 million in the year-ago quarter. Revenues in the quarter primarily included collaboration revenues from Bristol Myers Squibb (BMY - Free Report) .
Revenues for the third quarter of 2021 included collaboration revenues of $78.5 million from Bristol Myers for the option exercise and U.S. license for PRX005 and $60.7 million from the sale of the clinical-stage antibody NNC6019 (formerly PRX004) program and related rights to the company’s ATTR amyloidosis business and pipeline to Novo Nordisk (NVO - Free Report) .
The company’s shares have gained 18.1% in the year so far against the industry’s decline of 22.3%.
Image Source: Zacks Investment Research
Quarter in Detail
R&D expenses were $39.9 million, up from $18 million in the year-ago quarter, primarily due to higher manufacturing costs related to the birtamimab, PRX012, PRX019, PRX123 and PRX005 programs; higher personnel-related expenses; higher clinical trial expenses mainly related to the PRX012 and birtamimab programs; increased other R&D expenses and higher consulting expenses.
General and administrative (G&A) expenses were $12 million, roughly flat with the year-ago quarter.
As of Sep 30, 2022, Prothena had $497.0 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 advancing an early-stage pipeline of programs for a number of potential neurological indications with Bristol Myers. PRX005 — a potential treatment for Alzheimer’s disease (AD) — is an investigational antibody that targets tau, a protein implicated in diseases including AD, frontotemporal dementia, progressive supranuclear palsy, chronic traumatic encephalopathy and other tauopathies. A phase I study was initiated in 2021 and top-line data is expected shortly.
Prothena is also evaluating PRX012, an investigational high-potency monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) for treating AD. The FDA granted Fast Track designation to PRX012 for the treatment of AD. A phase I multiple ascending dose study is expected to be initiated by 2022-end and top-line data from the phase I study is expected in 2023.
The company is also developing a dual Aβ-Tau vaccine — a potential prevention and treatment for AD — to target key epitopes within Aβ and tau proteins to promote amyloid clearance and block pathogenic tau interaction. An Investigational New Drug application for the vaccine is anticipated in 2023.
The company is also evaluating prasinezumab in collaboration with Roche (RHHBY - Free Report) for the treatment of Parkinson’s disease. A phase IIb PADOVA study in patients with early Parkinson’s disease is being conducted by Roche and top-line data is expected in 2024.
It is also evaluating birtamimab, a potential treatment for AL amyloidosis. 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 in 2021. Results are expected in 2024.
Novo Nordisk has acquired Prothena’s clinical-stage antibody, PRX004 (now NNC6019) and a broader ATTR amyloidosis program. A phase II study of NNC6019 in patients with ATTR cardiomyopathy is being conducted by Novo Nordisk.
Prothena currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here