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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Prothena Corp. Plc - Ordinary Shares (MM) | NASDAQ:PRTAV | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 0 | - |
From Jul 2021 to Jul 2024
“We continued to make significant progress advancing our robust portfolio with our confirmatory Phase 3 AFFIRM-AL trial of birtamimab in AL amyloidosis and new preclinical data presented at AAIC that highlighted two of our potentially best-in-class Alzheimer’s programs, PRX012, a high-potency anti-Aβ antibody designed for subcutaneous administration to enhance patient access and compliance, and our dual Aβ-tau vaccine for the prevention and treatment of Alzheimer’s,” said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. “Additionally, multiple strategic collaborations delivered milestones with a combined $200 million in partner payments this year from Roche, Bristol Myers Squibb and Novo Nordisk. Progress across our portfolio continues to validate our scientific platform and capital earned through our strategic partnerships helps to advance our robust pipeline through key milestones. As we continue to work towards our mission to bring novel therapies to patients in need of new treatment options, we welcomed Sanjiv Patel to our board, who brings significant industry experience to advise Prothena as we transition to a fully integrated research, development and commercial biotechnology company.”
Second Quarter and Recent Business Highlights:
Multiple milestones from strategic collaborations
Birtamimab, a potential treatment for AL amyloidosis, is a humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure
Prasinezumab, a potential treatment for Parkinson’s disease, is a humanized monoclonal antibody designed to target a key epitope within the C-terminus of alpha-synuclein and is the focus of the worldwide collaboration with Roche
PRX004, a potential 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
PRX005, a potential 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
PRX012, a potential best-in-class treatment for AD, is a high-potency monoclonal antibody targeting a key epitope at the N-terminus of Aβ
Dual Aβ-Tau vaccine, a potential prevention and treatment for Alzheimer’s disease, is a dual vaccine targeting key epitopes within the Aβ and tau proteins to promote amyloid clearance and blockade pathogenic tau interaction
Corporate
Upcoming Milestones:
Birtamimab
Prasinezumab
PRX004
PRX005
PRX012
Dual Aβ-Tau vaccine
Second Quarter and First Six Months of 2021 Financial Results and Updated 2021 Financial Guidance
For the second quarter and first six months of 2021, Prothena reported a net income of $27.6 million and a net loss of $9.1 million, respectively, as compared to a net loss of $26.3 million and $49.9 million for the second quarter and first six months of 2020, respectively. Net income per share on a diluted basis for the second quarter of 2021 was $0.58 and net loss per share for the first six months of 2021, was $0.21, as compared to net loss per share of $0.66 and $1.25 for the second quarter and first six months of 2020, respectively.
Prothena reported total revenue of $60.1 million and $60.2 million for the second quarter and first six months of 2021, respectively, from collaboration and license revenue from Roche, as compared to total revenue of $0.2 million and $0.3 million for the second quarter and first six months of 2020, from collaboration and license revenue from Roche.
Research and development (R&D) expenses totaled $21.1 million and $42.2 million for the second quarter and first six months of 2021, respectively, as compared to $17.3 million and $32.5 million for the second quarter and first six months of 2020, respectively. The increase in R&D expense for the second quarter and first six months of 2021, compared to the same period in the prior year was primarily due to higher personnel expense, higher consulting expense, higher manufacturing expense primarily related to our PRX004 and PRX012 programs, higher clinical trial expense primarily related to birtamimab AFFIRM-AL trial, partially offset by lower PRX004 clinical trial expenses and lower collaboration expense with Roche related to the prasinezumab program as a result of the May 2021, cost share opt-out. R&D expenses included non-cash share-based compensation expense of $2.2 million and $4.2 million for the second quarter and first six months of 2021, respectively, as compared to $2.1 million and $4.1 million for the second quarter and first six months of 2020, respectively.
General and administrative (G&A) expenses totaled $11.0 million and $22.2 million for the second quarter and first six months of 2021, respectively, as compared to $9.7 million and $19.4 million for the second quarter and first six months of 2020, respectively. The increase in G&A expenses for the second quarter and first six months of 2021 compared to the same period in the prior year was primarily related to higher personnel expense, higher legal expense and higher expense for our director and officer insurance premium. G&A expenses included non-cash share-based compensation expense of $3.3 million and $7.5 million for the second quarter and first six months of 2021, respectively, as compared to $3.6 million and $7.1 million for the second quarter and first six months of 2020, respectively.
Total non-cash share-based compensation expense was $5.5 million and $11.7 million for the second quarter and first six months of 2021, respectively, as compared to $5.7 million and $11.2 million for the second quarter and first six months of 2020.
As of June 30, 2021, Prothena had $402.5 million in cash, cash equivalents and restricted cash (does not include the $60 million upfront payment from Novo Nordisk received in 3Q 2021 or the $80 million from Bristol Myers Squibb for the exclusive U.S. license to PRX005 expected in 3Q 2021) and no debt.
As of July 29, 2021, Prothena had approximately 45.0 million ordinary shares outstanding.
The Company is updating its projected full year 2021 net cash burn from operating and investing activities (prior guidance of $51 to $74 million) to net cash provided by operating and investing activities of $85 to $95 million and expects to end the year with approximately $491 million in cash, cash equivalents and restricted cash (midpoint) representing an increase of $175 million from prior guidance of $316 million. This increase in cash position is primarily driven by an $80 million milestone payment from Bristol Myers Squibb expected in 3Q 2021 for the exclusive U.S. license to PRX005 and a $60 million payment received from Novo Nordisk in 3Q 2021 for the acquisition of Prothena’s ATTR amyloidosis business, which are both included in operating activities. The updated estimated full year 2021 net cash provided by operating and investing activities is primarily driven by an updated estimated net income of $50 to $60 million (versus prior net loss guidance of $79 to $111 million), which includes the payments from Bristol Myers Squibb and Novo Nordisk mentioned above, as well as an estimated $25 million of non-cash share-based compensation expense.
PROTHENA CORPORATION PLCCONSOLIDATED STATEMENTS OF OPERATIONS(unaudited - amounts in thousands except per share data)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||||||
Collaboration revenue | $ | 60,071 | $ | 145 | $ | 60,181 | $ | 286 | ||||||||||||
License revenue | — | 50 | 50 | 50 | ||||||||||||||||
Total revenue | 60,071 | 195 | 60,231 | 336 | ||||||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development | 21,090 | 17,271 | 42,234 | 32,519 | ||||||||||||||||
General and administrative | 11,032 | 9,656 | 22,157 | 19,397 | ||||||||||||||||
Total operating expenses | 32,122 | 26,927 | 64,391 | 51,916 | ||||||||||||||||
Income (loss) from operations | 27,949 | (26,732 | ) | (4,160 | ) | (51,580 | ) | |||||||||||||
Other income (expense), net | (53 | ) | 195 | (19 | ) | 1,308 | ||||||||||||||
Income (loss) before income taxes | 27,896 | (26,537 | ) | (4,179 | ) | (50,272 | ) | |||||||||||||
Provision for (benefit from) income taxes | 254 | (255 | ) | 4,914 | (421 | ) | ||||||||||||||
Net income (loss) | $ | 27,642 | $ | (26,282 | ) | $ | (9,093 | ) | $ | (49,851 | ) | |||||||||
Basic net income (loss) per ordinary share | $ | 0.62 | $ | (0.66 | ) | $ | (0.21 | ) | $ | (1.25 | ) | |||||||||
Diluted net income (loss) per ordinary share | $ | 0.58 | $ | (0.66 | ) | $ | (0.21 | ) | $ | (1.25 | ) | |||||||||
Shares used to compute basic net income (loss) per share | 44,332 | 39,911 | 42,302 | 39,910 | ||||||||||||||||
Shares used to compute diluted net income (loss) per share | 47,414 | 39,911 | 42,302 | 39,910 |
PROTHENA CORPORATION PLCCONSOLIDATED BALANCE SHEETS(unaudited - amounts in thousands)
June 30, | December 31, | ||||||
2021 | 2020 | ||||||
Assets | |||||||
Cash and cash equivalents | $ | 399,831 | $ | 295,380 | |||
Accounts receivable | 3 | 15 | |||||
Prepaid expenses and other current assets | 8,282 | 2,537 | |||||
Restricted cash, current | 1,352 | 1,352 | |||||
Total current assets | 409,468 | 299,284 | |||||
Property and equipment, net | 2,080 | 2,551 | |||||
Operating lease right-of-use assets | 14,996 | 17,811 | |||||
Restricted cash, non-current | 1,352 | 1,352 | |||||
Other non-current assets | 8,482 | 11,977 | |||||
Total non-current assets | 26,910 | 33,691 | |||||
Total assets | $ | 436,378 | $ | 332,975 | |||
Liabilities and Shareholders’ Equity | |||||||
Accrued research and development | 8,375 | 9,044 | |||||
Deferred revenue, current | 24,949 | — | |||||
Lease liability, current | 5,723 | 5,512 | |||||
Other current liabilities | 13,852 | 11,292 | |||||
Total current liabilities | 52,899 | 25,848 | |||||
Deferred revenue, non current | 85,293 | 110,242 | |||||
Lease liability, non-current | 9,426 | 12,326 | |||||
Other non-current liabilities | 553 | 553 | |||||
Total non-current liabilities | 95,272 | 123,121 | |||||
Total liabilities | 148,171 | 148,969 | |||||
Total shareholders’ equity | 288,207 | 184,006 | |||||
Total liabilities and shareholders’ equity | $ | 436,378 | $ | 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; our goal of building a protein dysregulation platform; 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 Norkdisk; the expected timing of reporting data from prior clinical studies of birtamimab and the Phase 2 clinical study of prasinezumab; 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 August 5, 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 & Communications650-837-8535, jennifer.zibuda@prothena.com
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