Prothena Reports Third Quarter 2021 Financial Results and Business Highlights
Prothena Corporation reported strong financial results for Q3 and the first nine months of 2021, achieving a net income of $109.2 million for Q3 compared to a loss of $30.6 million in Q3 2020. Total revenue reached $139.2 million, including $78.5 million from Bristol Myers Squibb and $60.7 million from Novo Nordisk. The company has $601.5 million in cash and no debt. Prothena continues to advance its pipeline, including the ongoing Phase 3 trial of birtamimab and collaborations with notable partners, positioning itself for further growth.
- Net income increased to $109.2 million in Q3 2021 from a loss of $30.6 million in Q3 2020.
- Total revenue of $139.2 million in Q3 2021, a significant increase from $0.2 million in Q3 2020.
- Received $140 million in partner payments in Q3 2021 from Novo Nordisk and Bristol Myers Squibb.
- Cash position of $601.5 million with no debt, enhancing financial stability.
- Research and development expenses increased, totaling $18.0 million in Q3 2021, which might impact future profitability.
- Net cash provided by operating and investing activities was
$111.9 million in the third quarter and$114.8 million for the first nine months of 2021; Quarter-end cash and restricted cash position was$601.5 million - Received
$140 million from partner payments in third quarter from Novo Nordisk and Bristol Myers Squibb - Announced two key executive appointments to support transition to a fully integrated biotechnology company
DUBLIN, Ireland, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise, today reported financial results for the third quarter and first nine months of 2021. In addition, the Company provided business highlights and updated 2021 financial guidance.
“Prothena made significant progress across our portfolio in the third quarter. We presented scientific findings highlighting two of our potentially best-in-class Alzheimer’s disease programs and advanced our ongoing confirmatory Phase 3 trial of birtamimab in Mayo Stage IV patients with AL amyloidosis. Additionally, we announced the acquisition of our ATTR amyloidosis program by Novo Nordisk and executed the U.S. license agreement for our anti-tau targeting clinical candidate, PRX005, with Bristol Myers Squibb. Our strategic collaborations have continued to deliver value, contributing
Third Quarter and Recent Business Highlights:
Birtamimab, a potential best-in-class amyloid depleter treatment for AL amyloidosis, is an investigational humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure
- Confirmatory Phase 3 AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis is ongoing (NCT#04973137)
PRX004, a potential first-in-class treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein, and is being developed by Novo Nordisk for the treatment of ATTR cardiomyopathy
- Announced Novo Nordisk acquisition of ATTR amyloidosis business; Prothena is eligible to receive a total aggregate of up to
$1.23 billion - Received
$60 million upfront payment from Novo Nordisk to date
PRX005, a potential best-in-class treatment for Alzheimer’s disease (AD), is an investigational antibody 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 the global neuroscience research and development collaboration with Bristol Myers Squibb
- Received
$80 million option payment from Bristol Myers Squibb for execution of U.S. license agreement
PRX012, a potential best-in-class treatment for AD, is an investigational high-potency monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ)
- Presented preclinical results at the Alzheimer’s Association International Conference® 2021 (AAIC®) demonstrating that PRX012 significantly cleared both pyroglutamate-modified and -unmodified Aβ plaque in post-mortem brain tissue of late-stage AD patients
Dual Aβ-tau vaccine, a potential first-in-class prevention and treatment for AD, is a dual-target vaccine targeting key epitopes within the Aβ and tau proteins to promote amyloid clearance and blockade of pathogenic tau
- AAIC presentation showcased preclinical data demonstrating that Prothena’s dual Aβ-tau vaccine generated appropriate and balanced antibody titers promoting both phagocytosis of Aβ plaque and blockade of tau transmission in vitro
Corporate
- In October, the Company announced two executive appointments to support its transition to a fully integrated biotechnology company. Chief Financial Officer Tran Nguyen was appointed to the additional and newly created role of Chief Strategy Officer and Brandon Smith was appointed the role of Chief Operating Officer.
Key Upcoming Milestones:
PRX004
$40 million near-term clinical milestone payment from Novo Nordisk
PRX005
- Potential
$55 million option payment from Bristol Myers Squibb for global rights at the end of the ongoing Phase 1 study
PRX012
- Investigational New Drug Application (IND) expected 1Q 2022
Dual Aβ-Tau vaccine
- IND expected 2023
Upcoming Investor Conferences
Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:
- Stifel 2021 Virtual Healthcare Conference, November 16, 2021, at 2:00 PM ET
- Jefferies London Healthcare Conference, on demand presentations available starting November 18, 2021, at 8:00 AM GMT/3:00 AM ET
- Piper Sandler 33rd Annual Healthcare Conference, on demand presentations available starting November 22 at 10:00 AM ET
Third Quarter and First Nine Months of 2021 Financial Results and Updated 2021 Financial Guidance
For the third quarter and first nine months of 2021, Prothena reported a net income of
Prothena reported total revenue of
Research and development (R&D) expenses totaled
R&D expenses included non-cash share-based compensation expense of
General and administrative (G&A) expenses totaled
Total non-cash share-based compensation expense was
As of September 30, 2021, Prothena had
As of October 28, 2021, Prothena had approximately 46.6 million ordinary shares outstanding.
The Company continues to expect the full year 2021 net cash provided by operating and investing activities to be
PROTHENA CORPORATION PLC
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Collaboration revenue | $ | 78,480 | $ | 157 | $ | 138,661 | $ | 443 | |||||||
Revenue from license and intellectual property | 60,694 | — | 60,744 | 50 | |||||||||||
Total revenue | 139,174 | 157 | 199,405 | 493 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 17,992 | 21,605 | 60,226 | 54,124 | |||||||||||
General and administrative | 11,955 | 9,398 | 34,112 | 28,795 | |||||||||||
Total operating expenses | 29,947 | 31,003 | 94,338 | 82,919 | |||||||||||
Income (loss) from operations | 109,227 | (30,846 | ) | 105,067 | (82,426 | ) | |||||||||
Other income (expense), net | (31 | ) | 54 | (50 | ) | 1,362 | |||||||||
Income (loss) before income taxes | 109,196 | (30,792 | ) | 105,017 | (81,064 | ) | |||||||||
Provision for (benefit from) income taxes | (51 | ) | (215 | ) | 4,863 | (636 | ) | ||||||||
Net income (loss) | $ | 109,247 | $ | (30,577 | ) | $ | 100,154 | $ | (80,428 | ) | |||||
Basic net income (loss) per ordinary share | $ | 2.39 | $ | (0.77 | ) | $ | 2.31 | $ | (2.02 | ) | |||||
Diluted net income (loss) per ordinary share | $ | 2.13 | $ | (0.77 | ) | $ | 2.12 | $ | (2.02 | ) | |||||
Shares used to compute basic net income (loss) per share | 45,626 | 39,917 | 43,422 | 39,912 | |||||||||||
Shares used to compute diluted net income (loss) per share | 51,205 | 39,917 | 47,196 | 39,912 | |||||||||||
PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
September 30, | December 31, | ||||||
2021 | 2020 | ||||||
Assets | |||||||
Cash and cash equivalents | $ | 600,098 | $ | 295,380 | |||
Accounts receivable | 79 | 15 | |||||
Prepaid expenses and other current assets | 7,353 | 2,537 | |||||
Restricted cash, current | — | 1,352 | |||||
Total current assets | 607,530 | 299,284 | |||||
Property and equipment, net | 1,944 | 2,551 | |||||
Operating lease right-of-use assets | 13,567 | 17,811 | |||||
Restricted cash, non-current | 1,352 | 1,352 | |||||
Other non-current assets | 8,311 | 11,977 | |||||
Total non-current assets | 25,174 | 33,691 | |||||
Total assets | $ | 632,704 | $ | 332,975 | |||
Liabilities and Shareholders’ Equity | |||||||
Accrued research and development | 5,315 | 9,044 | |||||
Deferred revenue, current | 7,205 | — | |||||
Lease liability, current | 5,831 | 5,512 | |||||
Other current liabilities | 10,850 | 11,292 | |||||
Total current liabilities | 29,201 | 25,848 | |||||
Deferred revenue, non current | 104,557 | 110,242 | |||||
Lease liability, non-current | 7,922 | 12,326 | |||||
Other non-current liabilities | 553 | 553 | |||||
Total non-current liabilities | 113,032 | 123,121 | |||||
Total liabilities | 142,233 | 148,969 | |||||
Total shareholders’ equity | 490,471 | 184,006 | |||||
Total liabilities and shareholders’ equity | $ | 632,704 | $ | 332,975 |
About Prothena
Prothena Corporation plc is a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.
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 treatment potential, designs, and proposed mechanisms of action of birtamimab, prasinezumab, PRX004, PRX005, PRX012 and our dual Aβ-tau vaccine; plans for future clinical studies of birtamimab, prasinezumab, PRX004, PRX005, PRX012 and our dual Aβ-tau vaccine; amounts we might receive under our strategic collaborations with Roche, Bristol Myers Squibb and Novo Nordisk; our anticipated net cash burn from operating and investing activities for 2021 and expected cash balance at the end of 2021; and our estimated net loss and non-cash share-based compensation expense for 2021. 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 Securities and Exchange Commission (SEC) on November 4, 2021, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.
Media and Investors:
Jennifer Zibuda, Director, Investor Relations & Communications
650-837-8535, jennifer.zibuda@prothena.com
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