Prothena Reports Second Quarter 2024 Financial Results and Business Highlights
Prothena plc (NASDAQ:PRTA) reported financial results for Q2 2024, highlighting net income of $66.9 million and total revenue of $132.0 million. Key developments include:
1. Bristol Myers Squibb's $80 million exclusive global license for PRX019, a potential neurodegenerative disease treatment.
2. Ongoing clinical trials for PRX012 (Alzheimer's) and birtamimab (AL amyloidosis).
3. Revised year-end cash guidance to $468 million, up $63 million from previous guidance.
4. Expected topline results from four clinical programs within 12 months.
5. Q2 cash position of $565.0 million with no debt.
Prothena plc (NASDAQ:PRTA) ha riportato i risultati finanziari per il secondo trimestre del 2024, evidenziando un utile netto di 66,9 milioni di dollari e entrate totali di 132,0 milioni di dollari. I principali sviluppi includono:
1. Licenza globale esclusiva di 80 milioni di dollari da Bristol Myers Squibb per PRX019, un potenziale trattamento per le malattie neurodegenerative.
2. Studi clinici in corso per PRX012 (Alzheimer) e birtamimab (AL amiloidosi).
3. Previsioni di cassa riviste a 468 milioni di dollari entro la fine dell'anno, con un incremento di 63 milioni rispetto alle precedenti stime.
4. Risultati attesi da quattro programmi clinici entro 12 mesi.
5. Posizione di cassa per il Q2 di 565,0 milioni di dollari senza debiti.
Prothena plc (NASDAQ:PRTA) reportó los resultados financieros del segundo trimestre de 2024, destacando un ingreso neto de 66.9 millones de dólares y ingresos totales de 132.0 millones de dólares. Los principales desarrollos incluyen:
1. Licencia global exclusiva de 80 millones de dólares de Bristol Myers Squibb para PRX019, un tratamiento potencial para enfermedades neurodegenerativas.
2. Ensayos clínicos en curso para PRX012 (Alzheimer) y birtamimab (amiloidosis AL).
3. Guía de saldo de efectivo revisada a 468 millones de dólares, un aumento de 63 millones respecto a la guía anterior.
4. Resultados esperados de cuatro programas clínicos dentro de 12 meses.
5. Posición de efectivo en el Q2 de 565.0 millones de dólares sin deudas.
Prothena plc (NASDAQ:PRTA)는 2024년 2분기 재무 결과를 발표하며 순이익 6690만 달러 및 총수익 1억 3200만 달러를 강조했습니다. 주요 발전 사항은 다음과 같습니다:
1. Bristol Myers Squibb의 PRX019에 대한 8000만 달러의 독점 글로벌 라이선스, 이는 잠재적인 신경퇴행성 질환 치료제입니다.
2. PRX012(알츠하이머) 및 birtamimab(AL 아밀로이드증)에 대한 임상 시험이 진행 중입니다.
3. 연말 현금 가이던스를 4억 6800만 달러로 수정하여 이전 가이드보다 6300만 달러 증가했습니다.
4. 12개월 이내에 4개의 임상 프로그램에서 결과가 예상됩니다.
5. 2분기 현금 보유액은 5억 6500만 달러로 부채가 없습니다.
Prothena plc (NASDAQ:PRTA) a annoncé les résultats financiers du deuxième trimestre 2024, mettant en évidence un bénéfice net de 66,9 millions de dollars et un chiffre d'affaires total de 132,0 millions de dollars. Les principales avancées comprennent :
1. Une licence mondiale exclusive de 80 millions de dollars de Bristol Myers Squibb pour PRX019, un traitement potentiel pour les maladies neurodégénératives.
2. Des essais cliniques en cours pour PRX012 (Alzheimer) et birtamimab (amiloïdose AL).
3. Prévisions de liquidités révisées à 468 millions de dollars, en hausse de 63 millions par rapport aux prévisions précédentes.
4. Résultats attendus de quatre programmes cliniques d'ici 12 mois.
5. Position de trésorerie au Q2 de 565,0 millions de dollars sans dettes.
Prothena plc (NASDAQ:PRTA) hat die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und dabei einen Nettogewinn von 66,9 Millionen Dollar sowie einen Gesamtumsatz von 132,0 Millionen Dollar hervorgehoben. Wichtige Entwicklungen umfassen:
1. 80 Millionen Dollar exklusive globale Lizenz von Bristol Myers Squibb für PRX019, eine potenzielle Behandlung neurodegenerativer Erkrankungen.
2. Laufende klinische Studien für PRX012 (Alzheimer) und birtamimab (AL-Amyloidose).
3. Überarbeitete Liquiditätsprognose von 468 Millionen Dollar, was einen Anstieg von 63 Millionen gegenüber der vorherigen Schätzung bedeutet.
4. Erwartete Ergebnisse aus vier klinischen Programmen innerhalb von 12 Monaten.
5. Liquiditätsposition für Q2 beträgt 565,0 Millionen Dollar ohne Schulden.
- Net income of $66.9 million for Q2 2024, compared to a net loss in Q2 2023
- Total revenue increased to $132.0 million in Q2 2024 from $4.0 million in Q2 2023
- $80 million received from Bristol Myers Squibb for exclusive global license of PRX019
- Revised year-end cash guidance increased by $63 million to $468 million
- Strong cash position of $565.0 million with no debt as of June 30, 2024
- Fast Track designation granted by FDA for PRX012 and PRX123 for Alzheimer's disease treatment
- Net loss of $5.4 million for the first six months of 2024
- Increase in R&D expenses to $121.6 million for the first six months of 2024 compared to $100.8 million in 2023
- Increase in G&A expenses to $33.6 million for the first six months of 2024 compared to $28.3 million in 2023
Prothena's Q2 2024 results show a significant improvement in financial position. The company reported net income of
The cash position remains strong at
However, R&D and G&A expenses have increased, reflecting ongoing investment in clinical trials and personnel. The company's updated 2024 guidance projects a lower net loss range of
Prothena's pipeline shows promising progress across multiple neurodegenerative and rare disease programs. Key highlights include:
- PRX012 for Alzheimer's: Phase 1 data supports monthly subcutaneous administration, with updates expected in 2024.
- BMS-986446 (formerly PRX005): Partner Bristol Myers Squibb is conducting a Phase 2 trial in early Alzheimer's disease.
- Prasinezumab for Parkinson's: Topline results from the Phase 2b PADOVA trial expected in 2H 2024.
- Birtamimab for AL Amyloidosis: Confirmatory Phase 3 AFFIRM-AL trial results expected between Q4 2024 and Q2 2025.
The new PRX019 program, licensed to Bristol Myers Squibb, adds another potential treatment for neurodegenerative diseases to the pipeline. With multiple late-stage trials ongoing and data readouts expected within the next 12 months, Prothena is positioned for potential breakthroughs in challenging disease areas.
Prothena's strategic collaborations and pipeline advancements position it favorably in the competitive biotech landscape. The $80 million licensing deal with Bristol Myers Squibb for PRX019 not only provides immediate financial benefits but also validates Prothena's research capabilities. This deal, with potential additional milestones of up to
The company's focus on protein dysregulation in neurodegenerative and rare diseases addresses large, underserved markets. With potential first-in-class and best-in-class candidates in development, Prothena could capture significant market share if successful. The upcoming data readouts across multiple programs in the next 12 months could be major catalysts for the stock.
Investors should watch for the topline results from four clinical programs expected within a year, particularly the Phase 3 AFFIRM-AL trial for AL amyloidosis and the Phase 2b PADOVA trial for Parkinson's disease. These results could significantly impact Prothena's market valuation and potential commercial prospects.
-
Net cash provided by operating and investing activities was
$15.8 million $57.3 million $565.0 million -
Revised year-end cash guidance to be approximately
$468 million $63 million $405 million -
Bristol Myers Squibb obtained the exclusive global license for PRX019 for
$80 million - Partner Bristol Myers Squibb presented a poster for BMS-986446 at AAIC 2024 of the clinical trial design for the ongoing Phase 2 TargetTau-1 clinical trial to treat Alzheimer’s disease
- Presented poster for PRX012 at AAIC 2024 of the clinical trial design for the ongoing Phase 1 ASCENT clinical trial to treat Alzheimer’s disease; program update expected in 2024
- Highlighted poster for birtamimab at ISA 2024 of additional efficacy analysis from the VITAL Phase 3 clinical trial to treat AL amyloidosis; ongoing global confirmatory Phase 3 AFFIRM-AL clinical trial with topline results expected between 4Q 2024 and 2Q 2025
“We continue to meaningfully advance our programs and move towards becoming a fully integrated commercial company, which will enable Prothena to deliver transformative medicines for people living with devastating diseases caused by protein dysregulation. We recently announced that our collaboration with Bristol Myers Squibb generated a clinical development program with their exclusive global license of PRX019 for
Second Quarter, Recent Business Highlights and Upcoming Milestones
Neurodegenerative Diseases Portfolio
Alzheimer’s Disease
PRX012, a wholly-owned potential best-in-class, next-generation antibody delivered subcutaneously for the treatment of Alzheimer’s disease that targets a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency. The
- Poster presentation at AAIC 2024 highlighted the clinical trial design of the ongoing Phase 1 ASCENT program for PRX012
- Initial Phase 1 single ascending dose and multiple dose data supports once-monthly subcutaneous administration and ongoing evaluation in multiple dose cohorts
- Phase 1 clinical trial continues as planned and expect to update in 2024
BMS-986446 (formerly PRX005), a potential best-in-class antibody for the treatment of Alzheimer’s disease that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in the causal pathophysiology of Alzheimer’s disease.
- Poster presentation by partner Bristol Myers Squibb at AAIC 2024 highlighted the design of the ongoing Phase 2 TargetTau-1 clinical trial for BMS-986446
- Bristol Myers Squibb continues to enroll the ongoing Phase 2 clinical trial in approximately 475 patients with early Alzheimer’s disease for BMS-986446 (NCT06268886)
- Bristol Myers Squibb is responsible for all development, manufacturing, and commercialization of BMS-986446
PRX123, a wholly-owned potential first-in-class dual Aβ/tau vaccine designed for the treatment and prevention of Alzheimer’s disease, is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau designed to promote amyloid clearance and block the transmission of pathogenic tau. The FDA cleared the investigational new drug (IND) application and granted Fast Track designation for PRX123 for the treatment of Alzheimer’s disease.
- Phase 1 timeline update expected in 2024
Parkinson’s Disease
Prasinezumab, a potential first-in-class antibody for the treatment of Parkinson’s disease that is designed to target key epitopes within the C-terminus of alpha-synuclein, and is the focus of a worldwide collaboration with Roche.
-
Topline results from Phase 2b
PADOVA clinical trial in patients with early Parkinson’s disease, which has completed enrollment of 586 patients, expected in 2H 2024 (NCT04777331)
Neurodegenerative Diseases
PRX019, a potential treatment of neurodegenerative diseases with an undisclosed target.
-
Bristol Myers Squibb obtained the exclusive global license for PRX019 for
$80 million -
As part of the PRX019 global license with Bristol Myers Squibb, Prothena will be eligible to receive additional development, regulatory, and sales milestone payments of up to
$617.5 million - Prothena will initiate a Phase 1 clinical trial for PRX019 by year-end 2024
Rare Peripheral Amyloid Diseases Portfolio
AL Amyloidosis
Birtamimab, a wholly-owned potential best-in-class anti-amyloid antibody for the treatment of AL amyloidosis designed to directly neutralize soluble toxic light chain aggregates and promote clearance of amyloid that causes organ dysfunction and failure. Among patients with AL amyloidosis, a rare, progressive, and fatal disease, newly diagnosed individuals with advanced disease (e.g., Mayo Stage IV) are at the highest risk for early death. Birtamimab has been granted Fast Track designation by the FDA for the treatment of patients with Mayo Stage IV AL amyloidosis to reduce the risk of mortality and has been granted Orphan Drug Designation by both the FDA and European Medicines Agency. A significant survival benefit was observed in the post hoc analysis of birtamimab-treated patients categorized as Mayo Stage IV at baseline in the previous Phase 3 VITAL clinical trial (Blood 2023).
- Longitudinal Health-Related Quality of Life data (SF-36v2) across domains from the VITAL Phase 3 clinical trial for birtamimab was presented at the International Society of Amyloidosis (ISA) 2024 meeting
- The ongoing confirmatory Phase 3 AFFIRM-AL clinical trial in patients with Mayo Stage IV AL amyloidosis is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA with a primary endpoint of all-cause mortality (time-to-event) at a significance level of 0.10
- Topline results from confirmatory AFFIRM-AL Phase 3 clinical trial expected between 4Q 2024 and 2Q 2025 (NCT04973137)
ATTR Amyloidosis
Coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody for the treatment of ATTR cardiomyopathy 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
- Ongoing Phase 2 clinical trial in patients with ATTR cardiomyopathy is being conducted by Novo Nordisk
- Phase 2 clinical trial has completed enrollment of approximately 99 patients with topline data expected in 1H 2025 (NCT05442047)
Second Quarter and First Six Months of 2024 Financial Results
For the second quarter and first six months of 2024, Prothena reported net income of
Prothena reported total revenue of
Research and development (R&D) expenses totaled
General and administrative (G&A) expenses totaled
Total non-cash share-based compensation expense was
As of June 30, 2024, Prothena had
As of August 1, 2024, Prothena had approximately 53.8 million ordinary shares outstanding.
2024 Financial Guidance
The Company is updating it projected full year 2024 net cash used in operating and investing actives, and expects it to be
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid 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 and completion of our ongoing clinical trials; the continued advancement of our discovery, preclinical, and clinical pipeline, and expected milestones in 2024, 2025, and beyond; the treatment potential, designs, proposed mechanisms of action, and potential administration of PRX012, BMS-986446/PRX005, PRX123, prasinezumab, PRX019, birtamimab, and coramitug/PRX004; plans for ongoing and future clinical studies of PRX012, BMS-986446/PRX005, PRX123, prasinezumab, PRX019, birtamimab, and coramitug/PRX004; the expected timing of reporting data from clinical studies, including any updates regarding our ongoing Phase 1 clinical trial evaluating PRX012 in 2024 and topline study results for our Phase 3 AFFIRM-AL clinical trial between 4Q 2024 and 2Q 2025; amounts we might receive under our collaboration with BMS; our anticipated net cash burn from operating and investing activities for 2024 and expected cash balance at the end of 2024; and our estimated net loss and non-cash share-based compensation expense for 2024. 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 8, 2024, and 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.
PROTHENA CORPORATION PLC |
||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
(unaudited - amounts in thousands except per share data) |
||||||||||||||||
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Collaboration revenue |
|
$ |
132,014 |
|
|
$ |
4,019 |
|
|
$ |
132,014 |
|
|
$ |
6,138 |
|
Revenue from license and intellectual property |
|
|
— |
|
|
|
— |
|
|
|
50 |
|
|
|
50 |
|
Total revenue |
|
|
132,014 |
|
|
|
4,019 |
|
|
|
132,064 |
|
|
|
6,188 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
|
57,510 |
|
|
|
56,011 |
|
|
|
121,624 |
|
|
|
100,767 |
|
General and administrative |
|
|
16,127 |
|
|
|
14,512 |
|
|
|
33,591 |
|
|
|
28,250 |
|
Total operating expenses |
|
|
73,637 |
|
|
|
70,523 |
|
|
|
155,215 |
|
|
|
129,017 |
|
Income (loss) from operations |
|
|
58,377 |
|
|
|
(66,504 |
) |
|
|
(23,151 |
) |
|
|
(122,829 |
) |
Total other income, net |
|
|
6,470 |
|
|
|
7,603 |
|
|
|
13,558 |
|
|
|
14,152 |
|
Income (loss) before income taxes |
|
|
64,847 |
|
|
|
(58,901 |
) |
|
|
(9,593 |
) |
|
|
(108,677 |
) |
Benefit from income taxes |
|
|
(2,039 |
) |
|
|
(4,306 |
) |
|
|
(4,240 |
) |
|
|
(7,218 |
) |
Net income (loss) |
|
$ |
66,886 |
|
|
$ |
(54,595 |
) |
|
$ |
(5,353 |
) |
|
$ |
(101,459 |
) |
Basic net income (loss) per ordinary share |
|
$ |
1.24 |
|
|
$ |
(1.03 |
) |
|
$ |
(0.10 |
) |
|
$ |
(1.92 |
) |
Diluted net income (loss) per ordinary share |
|
$ |
1.22 |
|
|
$ |
(1.03 |
) |
|
$ |
(0.10 |
) |
|
$ |
(1.92 |
) |
Shares used to compute basic net income (loss) per share |
|
|
53,767 |
|
|
|
53,121 |
|
|
|
53,740 |
|
|
|
52,812 |
|
Shares used to compute diluted net income (loss) per share |
|
|
55,043 |
|
|
|
53,121 |
|
|
|
53,740 |
|
|
|
52,812 |
|
PROTHENA CORPORATION PLC |
||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||
(unaudited - amounts in thousands) |
||||||
|
June 30, |
|
December 31, |
|||
|
|
2024 |
|
|
2023 |
|
Assets |
|
|
|
|||
Cash and cash equivalents |
$ |
564,124 |
|
$ |
618,830 |
|
Restricted cash, current |
|
— |
|
|
1,352 |
|
Prepaid expenses and other current assets |
|
21,854 |
|
|
19,100 |
|
Total current assets |
|
585,978 |
|
|
639,282 |
|
Property and equipment, net |
|
3,486 |
|
|
3,836 |
|
Operating lease right-of-use assets |
|
12,066 |
|
|
12,162 |
|
Restricted cash, non-current |
|
860 |
|
|
860 |
|
Other non-current assets |
|
43,175 |
|
|
40,242 |
|
Total non-current assets |
|
59,587 |
|
|
57,100 |
|
Total assets |
$ |
645,565 |
|
$ |
696,382 |
|
Liabilities and Shareholders’ Equity |
|
|
|
|||
Accrued research and development |
|
15,927 |
|
|
14,724 |
|
Deferred revenue, current |
|
8,025 |
|
|
— |
|
Lease liability, current |
|
2,579 |
|
|
1,114 |
|
Other current liabilities |
|
20,213 |
|
|
41,053 |
|
Total current liabilities |
|
46,744 |
|
|
56,891 |
|
Deferred revenue, non-current |
|
7,366 |
|
|
67,405 |
|
Lease liability, non-current |
|
9,538 |
|
|
10,721 |
|
Total non-current liabilities |
|
16,904 |
|
|
78,126 |
|
Total liabilities |
|
63,648 |
|
|
135,017 |
|
Total shareholders’ equity |
|
581,917 |
|
|
561,365 |
|
Total liabilities and shareholders’ equity |
$ |
645,565 |
|
$ |
696,382 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240808568805/en/
Investors
Mark Johnson, CFA, Vice President, Investor Relations
650-417-1974, mark.johnson@prothena.com
Media
Michael Bachner, Senior Director, Corporate Communications
609-664-7308, michael.bachner@prothena.com
Source: Prothena Corporation plc
FAQ
What was Prothena's (PRTA) net income for Q2 2024?
How much did Bristol Myers Squibb pay for the exclusive global license of PRX019?
What is Prothena's (PRTA) revised year-end cash guidance for 2024?
When are topline results expected for Prothena's (PRTA) AFFIRM-AL Phase 3 clinical trial?
What was Prothena's (PRTA) cash position at the end of Q2 2024?
