Prothena Corporation PRTA reported fourth-quarter 2022 earnings of 12 cents per share against the Zacks Consensus Estimate of a loss of 64 cents per share. In the year-ago quarter, the clinical-stage company had reported a loss of 71 cents per share.
Higher revenues in the reported drove the bottom line.
Total revenues were $49.9 million in the fourth quarter, beating the Zacks Consensus Estimate of $35 million and our estimate of $40 million, and increasing from $1.2 million in the year-ago quarter. Revenues in the quarter primarily included collaboration revenues of $40.0 million in milestone payments from Novo Nordisk NVO and collaboration revenues of $9.9 million from Bristol-Myers Squibb BMY.
Novo Nordisk acquired Prothena’s clinical-stage antibody, PRX004 (now NNC6019), and a broader ATTR amyloidosis program. The company received a $40-million milestone payment from Novo Nordisk in December 2022 related to the continued advancement of NNC6019 in a phase II study.
The company’s shares have jumped 47.2% in the year so far against the industry’s decline of 8.8%.
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Quarter in Detail
R&D expenses were $36.9 million, up from $22 million in the year-ago quarter primarily due to higher manufacturing costs, increased personnel-related expenses, higher clinical trial costs, higher consulting, and other R&D expenses.
General and administrative expenses were $13.1 million, up from $12.2 million in the year-ago quarter, primarily linked to higher personnel-related and consulting expenses, offset in part by lower legal expenses.
As of Dec 31, 2022, Prothena had $712 million in cash, cash equivalents and restricted cash, and no debt, up from $497.0 million at September’s end. The company raised net proceeds of $172.4 million through an underwritten public follow-on offering of 3,250,000 ordinary shares in December 2022.
Prothena is evaluating PRX012 — an investigational high-potency monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) — for treating Alzheimer’s disease (AD). The company received clearance for the investigational new drug (IND) application from the FDA in March 2022 and initiated phase I single ascending dose (SAD) and multi ascending dose (MAD) studies in healthy volunteers and patients with AD. The top-line data from these studies is expected by the end of this year.
Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications with Bristol-Myers. PRX005 — a potential treatment for 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. The company reported the top-line data from the phase I SAD study last month, which showed single doses of PRX005 across three dose cohorts were generally safe and well-tolerated, meeting the primary objective of the study. The top-line data from the ongoing phase I MAD study is expected later 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 IND application filing for the vaccine is anticipated in 2023.
The company is also evaluating prasinezumab in collaboration with Roche RHHBY for the treatment of Parkinson’s disease (PD). A phase IIb PADOVA study in patients with early Parkinson’s disease is being conducted by Roche and the top-line data is expected in 2024. Results from the phase II PASADENA study support a potential effect on delaying motor progression in patients with early PD.
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.
Prothena 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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