Prothena Reports Fourth Quarter and Full Year 2022 Financial Results, and Provides Financial Guidance and Business Highlights
Prothena Corporation (NASDAQ:PRTA) reported a net income of $6.3 million in Q4 2022, contrasting with a net loss of $116.9 million for the full year. Total revenue fell to $49.9 million in Q4 and $53.9 million for the year, significantly down from $1.2 million and $200.6 million in 2021, respectively. The operating cash use was $5.1 million in Q4 and $109.3 million for the year, with a cash position of $712.6 million. Noteworthy achievements include FDA clearance for PRX012’s IND application and a $40 million milestone from Novo Nordisk. The company anticipates utilizing $213 to $229 million in 2023, predicting a net cash of roughly $512 million by year end.
- FDA clearance and Fast Track designation for PRX012.
- Received $40 million milestone payment from Novo Nordisk.
- Raised $172.4 million through a public offering.
- Total revenue decreased significantly from 2021 figures.
- Net loss of $116.9 million for the full year 2022.
-
Net cash used in operating and investing activities was
in the fourth quarter and$5.1 million for the full year of 2022; quarter-end cash and restricted cash position was$109.3 million $712.6 million
- Advanced potential best-in-class Alzheimer’s Disease portfolio in 2022: received FDA clearance for IND application and Fast Track designation granted for PRX012, an investigational anti-Aβ antibody therapy; initiated Phase 1 SAD and MAD study for PRX012; completed Phase 1 SAD and initiated MAD study for PRX005, an investigational tri-epitopic antibody that specifically binds within the MTBR-tau
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Strengthened leadership position in the amyloidosis community with the ongoing enrollment of the confirmatory Phase 3 AFFIRM-AL study of birtamimab in patients with Mayo Stage
IV AL amyloidosis and multiple 2022 scientific publications and presentations, including data presented at ASH
-
Received
milestone payment from Novo Nordisk in$40 million December 2022 for advancement of NNC6019 (formerly PRX004) in a Phase 2 study for potential treatment of ATTR cardiomyopathy
-
Raised net proceeds of
in$172.4 million December 2022 through an underwritten public follow-on offering of 3,250,000 ordinary shares
“In 2022 we meaningfully advanced our protein dysregulation portfolio as we continue our transition to a fully integrated commercial company. The foundation we established in 2022 has positioned the next 24 months as a transformational period for
2022 Business Highlights and Upcoming Milestones
Neurodegenerative Diseases Portfolio
Alzheimer’s Disease (AD)
PRX012, a potential best-in-class, next-generation subcutaneous antibody for the treatment of AD, that targets a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency
-
Received clearance from the
U.S. Food and Drug Administration (FDA) inMarch 2022 for the investigational new drug (IND) application -
FDA granted Fast Track designation in
April 2022 - Initiated Phase 1 single ascending dose (SAD) and multi ascending dose (MAD) studies in healthy volunteers and patients with AD
-
Significant presence at upcoming
International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) in March/April 2023 highlighted by oral presentation of preclinical data showing superior binding characteristics of PRX012 and a symposium featuring key thought leaders - Ongoing Phase 1 SAD and MAD studies; topline data expected year end 2023
PRX005, a potential best-in-class antibody, for the treatment of AD that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE), and other tauopathies. PRX005 is part of a global neuroscience research and development collaboration with Bristol Myers Squibb
-
Topline data from Phase 1 SAD study announced
January 2023 showing single doses of PRX005 across three dose cohorts were generally safe and well tolerated, meeting the primary objective of the study; results expected from the Phase 1 SAD study at an upcoming medical conference - Ongoing Phase 1 MAD study; topline data expected year end 2023
PRX123, a potential first-in-class dual Aβ/tau vaccine, for the treatment and prevention of AD, that is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau to promote amyloid clearance and blockade of pathogenic tau
- Oral presentation on preclinical data at AD/PD 2022 demonstrated that Prothena’s dual Aβ/tau vaccine generated anti-Aβ and anti-MTBR-tau antibodies to enable clearance of Aβ and to inhibit cell-to-cell transmission of pathogenic tau species
- Investigational new drug (IND) application filing expected by year end 2023
Parkinson’s Disease (PD)
Prasinezumab, a potential first-in-class antibody, for the treatment of PD, that is designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of a worldwide collaboration with Roche
- Oral presentation by partner Roche at AD/PD 2022 of the Phase 2 PASADENA study further supports a potential effect on delaying motor progression in patients with early PD
-
Ongoing Phase 2b
PADOVA trial in patients with early PD is being conducted by Roche (NCT04777331); topline data expected in 2024
Rare Peripheral Amyloid Diseases Portfolio
AL Amyloidosis
Birtamimab, a potential best-in-class amyloid depleter antibody, for the treatment of AL amyloidosis, that is designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure
-
Poster presented at the XVIII International Symposium on Amyloidosis (ISA) in
September 2022 titled: Birtamimab in Patients with Mayo StageIV AL Amyloidosis : Rationale for Confirmatory AFFIRM-AL Phase 3 trial -
Oral presentation at the 2022
American Society of Hematology (ASH) Annual Meeting and Exposition inDecember 2022 : Consistent Survival Benefit Observed with Birtamimab in Mayo Stage IV AL Amyloidosis Patients in Phase 3 VITAL Study -
Published data on in-hospital mortality in amyloid light chain amyloidosis in
Journal of Comparative Effectiveness Research - Confirmatory Phase 3 AFFIRM-AL trial ongoing (NCT04973137); topline data expected in 2024
ATTR Amyloidosis
NNC6019 (formerly PRX004), a potential first-in-class antibody, for the treatment of ATTR cardiomyopathy, that is designed to deplete the pathogenic, non-native forms of the transthyretin (TTR) protein and is being developed by Novo Nordisk as part of their up to
-
Received
milestone payment from Novo Nordisk in$40 million December 2022 related to the continued advancement of NNC6019 in a Phase 2 study - Ongoing Phase 2 study in patients with ATTR cardiomyopathy is being conducted by Novo Nordisk (NCT05442047); topline data expected in 2024
2022 Organizational and Corporate Highlights
-
Announced the appointment of
Helen S. Kim , MBA, to its Board of Directors. With the appointment ofMs. Kim ,Prothena expanded its Board to 10 directors -
Raised net proceeds of
through an underwritten public follow-on offering of 3,250,000 ordinary shares in$172.4 million December 2022
Upcoming Investor Conferences
Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:
-
Oppenheimer 33rd Annual Healthcare Conference on
Monday, March 13, 2023 ; a fireside chat will be held at10:00 AM ET -
Jefferies Biotech on the Bay Summit on
Thursday, March 16, 2023 ; 1 on 1 investor meetings will be held
Fourth Quarter and Full Year of 2022 Financial Results
For the fourth quarter and full year of 2022,
Research and development (R&D) expenses totaled
General and administrative (G&A) expenses totaled
Total non-cash share-based compensation expense was
As of
As of
2023 Financial Guidance
The Company expects the full year 2023 net cash used in operating and investing activities to be
Conference Call Details
To access the call via dial-in, please dial +1 (888) 350-3870 (
About
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to fund advancement of a broad pipeline; the continued advancement of our discovery, preclinical, and clinical pipeline, and expected milestones in 2023 and beyond; the treatment potential, designs, proposed mechanisms of action, and potential administration of birtamimab, prasinezumab, PRX004, PRX005, PRX012, and PRX123; plans for future clinical studies of birtamimab, prasinezumab, PRX004, PRX005, PRX012, and PRX123 (including the filing of an IND application); the expected timing of reporting data from clinical studies of birtamimab, prasinezumab, PRX004, PRX005, and PRX012; our anticipated net cash burn from operating and investing activities for 2023 and expected cash balance at the end of 2023; and our estimated net loss and non-cash share-based compensation expense for 2023. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited - amounts in thousands except per share data) |
||||||||||||
|
|
Three Months Ended
|
|
Year Ended
|
||||||||
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
Collaboration revenue |
|
$ |
9,923 |
|
$ |
1,172 |
|
$ |
13,855 |
|
$ |
139,833 |
Revenue from license and intellectual property |
|
|
40,000 |
|
|
— |
|
|
40,050 |
|
|
60,744 |
Total revenue |
|
|
49,923 |
|
|
1,172 |
|
|
53,905 |
|
|
200,577 |
Operating expenses: |
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
36,871 |
|
|
22,058 |
|
|
135,562 |
|
|
82,284 |
General and administrative |
|
|
13,124 |
|
|
12,206 |
|
|
49,900 |
|
|
46,318 |
Total operating expenses |
|
|
49,995 |
|
|
34,264 |
|
|
185,462 |
|
|
128,602 |
Income (loss) from operations |
|
|
(72) |
|
|
(33,092) |
|
|
(131,557) |
|
|
71,975 |
Other income (expense), net |
|
|
3,417 |
|
|
(4) |
|
|
5,952 |
|
|
(54) |
Income (loss) before income taxes |
|
|
3,345 |
|
|
(33,096) |
|
|
(125,605) |
|
|
71,921 |
Provision for (benefit from) income taxes |
|
|
(3,004) |
|
|
83 |
|
|
(8,656) |
|
|
4,946 |
Net income (loss) |
|
$ |
6,349 |
|
$ |
(33,179) |
|
$ |
(116,949) |
|
$ |
66,975 |
Basic net income (loss) per ordinary share |
|
$ |
0.13 |
|
$ |
(0.71) |
|
$ |
(2.47) |
|
$ |
1.51 |
Diluted net income (loss) per ordinary share |
|
$ |
0.12 |
|
$ |
(0.71) |
|
$ |
(2.47) |
|
$ |
1.38 |
Shares used to compute basic net income (loss) per share |
|
|
48,960 |
|
|
46,618 |
|
|
47,369 |
|
|
44,228 |
Shares used to compute diluted net income (loss) per share |
|
|
53,979 |
|
|
46,618 |
|
|
47,369 |
|
|
48,464 |
CONSOLIDATED BALANCE SHEETS (unaudited - amounts in thousands) |
|||||
|
|
|
|
||
|
|
2022 |
|
|
2021 |
Assets |
|
|
|
||
Cash and cash equivalents |
$ |
710,406 |
|
$ |
579,094 |
Prepaid expenses and other current assets |
|
8,692 |
|
|
5,715 |
Total current assets |
|
719,098 |
|
|
584,809 |
Property and equipment, net |
|
1,731 |
|
|
2,012 |
Operating lease right-of-use assets |
|
6,277 |
|
|
12,123 |
Restricted cash, non-current |
|
2,212 |
|
|
1,352 |
Other non-current assets |
|
28,717 |
|
|
9,070 |
Total non-current assets |
|
38,937 |
|
|
24,557 |
Total assets |
$ |
758,035 |
|
$ |
609,366 |
Liabilities and Shareholders’ Equity |
|
|
|
||
Accrued research and development |
|
10,794 |
|
|
6,351 |
Deferred revenue, current |
|
11,442 |
|
|
7,657 |
Lease liability, current |
|
6,473 |
|
|
5,940 |
Other current liabilities |
|
21,438 |
|
|
13,504 |
Total current liabilities |
|
50,147 |
|
|
33,452 |
Deferred revenue, non current |
|
85,293 |
|
|
102,933 |
Lease liability, non-current |
|
— |
|
|
6,386 |
Other non-current liabilities |
|
553 |
|
|
553 |
Total non-current liabilities |
|
85,846 |
|
|
109,872 |
Total liabilities |
|
135,993 |
|
|
143,324 |
Total shareholders’ equity |
|
622,042 |
|
|
466,042 |
Total liabilities and shareholders’ equity |
$ |
758,035 |
|
$ |
609,366 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230223005196/en/
Media
609-664-7308, michael.bachner@prothena.com
Investors
IR@prothena.com
Source:
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