Protalix BioTherapeutics Reports Fiscal Year 2024 Financial and Business Results
Protalix BioTherapeutics (PLX) reported strong financial results for fiscal year 2024, with record revenues from goods sales reaching $53.0 million, a 31% increase from 2023. The growth was primarily driven by an $11.8 million increase in sales to Chiesi.
Research and development expenses decreased 24% to $13.0 million, while selling, general and administrative expenses fell 19% to $12.2 million. The company reported net income of $2.9 million ($0.04 per share) compared to $8.3 million in 2023.
Key developments include successful completion of First-in-Human phase I trial for PRX-115 (gout treatment candidate), full repayment of outstanding debt, and EMA validation of pegunigalsidase alfa variation submission for less frequent dosing in Fabry disease. The company ended 2024 with $34.8 million in cash and equivalents.
Protalix BioTherapeutics (PLX) ha riportato risultati finanziari solidi per l'anno fiscale 2024, con ricavi record dalle vendite di beni che hanno raggiunto 53,0 milioni di dollari, un aumento del 31% rispetto al 2023. La crescita è stata principalmente guidata da un incremento delle vendite a Chiesi di 11,8 milioni di dollari.
Le spese per ricerca e sviluppo sono diminuite del 24% a 13,0 milioni di dollari, mentre le spese di vendita, generali e amministrative sono scese del 19% a 12,2 milioni di dollari. L'azienda ha riportato un reddito netto di 2,9 milioni di dollari (0,04 dollari per azione) rispetto a 8,3 milioni di dollari nel 2023.
Tra i principali sviluppi ci sono il completamento con successo della fase I dello studio clinico First-in-Human per PRX-115 (candidato per il trattamento della gotta), il rimborso completo del debito in sospeso e la validazione da parte dell'EMA della variazione della domanda per pegunigalsidase alfa per dosaggi meno frequenti nella malattia di Fabry. L'azienda ha chiuso il 2024 con 34,8 milioni di dollari in contante e equivalenti.
Protalix BioTherapeutics (PLX) informó resultados financieros sólidos para el año fiscal 2024, con ingresos récord por ventas de bienes alcanzando 53,0 millones de dólares, un aumento del 31% en comparación con 2023. El crecimiento fue impulsado principalmente por un aumento de 11,8 millones de dólares en ventas a Chiesi.
Los gastos de investigación y desarrollo disminuyeron un 24% a 13,0 millones de dólares, mientras que los gastos de venta, generales y administrativos cayeron un 19% a 12,2 millones de dólares. La empresa reportó un ingreso neto de 2,9 millones de dólares (0,04 dólares por acción) en comparación con 8,3 millones de dólares en 2023.
Los desarrollos clave incluyen la finalización exitosa del ensayo clínico First-in-Human fase I para PRX-115 (candidato para el tratamiento de la gota), el reembolso completo de la deuda pendiente y la validación por parte de la EMA de la solicitud de variación para pegunigalsidase alfa para dosificación menos frecuente en la enfermedad de Fabry. La empresa terminó 2024 con 34,8 millones de dólares en efectivo y equivalentes.
Protalix BioTherapeutics (PLX)는 2024 회계연도에 강력한 재무 결과를 보고했으며, 상품 판매에서 기록적인 수익인 5,300만 달러를 기록하여 2023년 대비 31% 증가했습니다. 이 성장은 주로 Chiesi에 대한 1,180만 달러의 판매 증가에 의해 주도되었습니다.
연구 및 개발 비용은 24% 감소하여 1,300만 달러에 이르렀고, 판매, 일반 및 관리 비용은 19% 감소하여 1,220만 달러가 되었습니다. 회사는 2023년 830만 달러에 비해 290만 달러의 순이익(주당 0.04달러)을 보고했습니다.
주요 개발 사항으로는 PRX-115(통풍 치료 후보)의 First-in-Human 1상 시험의 성공적인 완료, 미지급 부채의 전액 상환, Fabry병의 덜 빈번한 투약을 위한 pegunigalsidase alfa 변형 제출의 EMA 인증이 포함됩니다. 회사는 2024년을 3,480만 달러의 현금 및 현금성 자산으로 마감했습니다.
Protalix BioTherapeutics (PLX) a annoncé de solides résultats financiers pour l'exercice fiscal 2024, avec des revenus record provenant des ventes de biens atteignant 53,0 millions de dollars, soit une augmentation de 31 % par rapport à 2023. Cette croissance a été principalement tirée par une augmentation de 11,8 millions de dollars des ventes à Chiesi.
Les dépenses de recherche et développement ont diminué de 24 % pour atteindre 13,0 millions de dollars, tandis que les dépenses de vente, générales et administratives ont chuté de 19 % pour s'établir à 12,2 millions de dollars. L'entreprise a déclaré un bénéfice net de 2,9 millions de dollars (0,04 dollar par action) par rapport à 8,3 millions de dollars en 2023.
Parmi les développements clés figurent l'achèvement réussi de l'essai clinique First-in-Human de phase I pour PRX-115 (candidat au traitement de la goutte), le remboursement intégral de la dette en cours et la validation par l'EMA de la soumission de variation pour pegunigalsidase alfa pour une posologie moins fréquente dans la maladie de Fabry. L'entreprise a terminé 2024 avec 34,8 millions de dollars en liquidités et équivalents.
Protalix BioTherapeutics (PLX) berichtete über starke finanzielle Ergebnisse für das Geschäftsjahr 2024, mit Rekordumsätzen aus Warenverkäufen von 53,0 Millionen Dollar, was einem Anstieg von 31% im Vergleich zu 2023 entspricht. Das Wachstum wurde hauptsächlich durch einen Anstieg der Verkäufe an Chiesi um 11,8 Millionen Dollar vorangetrieben.
Die Forschungs- und Entwicklungskosten sanken um 24% auf 13,0 Millionen Dollar, während die Vertriebs-, allgemeinen und Verwaltungskosten um 19% auf 12,2 Millionen Dollar fielen. Das Unternehmen berichtete von einem Nettogewinn von 2,9 Millionen Dollar (0,04 Dollar pro Aktie) im Vergleich zu 8,3 Millionen Dollar im Jahr 2023.
Wichtige Entwicklungen umfassen den erfolgreichen Abschluss der First-in-Human Phase-I-Studie für PRX-115 (Kandidat zur Behandlung von Gicht), die vollständige Rückzahlung der ausstehenden Schulden und die Validierung der EMA für die Einreichung der Variante von Pegunigalsidase Alfa für weniger häufige Dosierung bei der Fabry-Krankheit. Das Unternehmen schloss das Jahr 2024 mit 34,8 Millionen Dollar an Bargeld und Äquivalenten ab.
- Record revenue from goods sales of $53.0M, up 31% YoY
- Successful debt repayment strengthening balance sheet
- Positive Phase I results for PRX-115 gout treatment
- EMA validation for new dosing regimen of pegunigalsidase alfa
- Net income of $2.9M in 2024
- License and R&D services revenue decreased 98% to $0.4M
- Net income declined from $8.3M in 2023 to $2.9M in 2024
- Income tax expense increased 300% to $1.2M
Insights
Protalix's 2024 financial results present a mixed but overall positive picture despite headline numbers appearing contradictory. While total revenue decreased year-over-year, this decline masks a significant operational improvement - product revenue increased 31% to $53 million, demonstrating strong commercial execution. The revenue drop stems primarily from non-recurring licensing payments received in 2023 ($20 million milestone payment).
The company achieved three critical financial milestones: 1) Complete debt elimination, strengthening the balance sheet; 2) Resolution of all outstanding warrants, removing dilutive overhang; and 3) Growth across all three revenue streams (Chiesi, Pfizer, Brazil). Most impressively, they maintained profitability with $2.9 million in net income despite the absence of milestone payments.
Cost discipline appears strong with R&D expenses down 24% and SG&A expenses reduced by 19%. This reflects appropriate scaling of expenses following the completion of their Fabry clinical program. With $34.8 million cash on hand and no debt, Protalix has approximately 2-3 years of operational runway at current burn rates.
The company's improved financial profile supports their planned phase II trial for PRX-115 (gout candidate) in late 2025. The expansion of pegunigalsidase alfa's dosing flexibility (4-week regimen) could enhance market adoption and competitiveness in the Fabry disease space.
Protalix's clinical progress in 2024 represents meaningful advancement of their pipeline beyond their marketed Fabry disease therapy. The successful completion of the First-in-Human phase I trial for PRX-115 in gout provides preliminary evidence for two important product differentiators: potential efficacy and extended dosing intervals. The latter could significantly improve treatment adherence - a critical factor in gout management.
The data presentation at the prestigious American College of Rheumatology conference indicates sufficient clinical interest to warrant continued development. Their planned progression to phase II in H2 2025 follows a logical development timeline.
On the regulatory front, the EMA validation of pegunigalsidase alfa's less frequent dosing regimen (2mg/kg every four weeks) represents a potential competitive advantage. The ability to offer monthly dosing versus bi-weekly administration could meaningfully improve the patient experience for this chronic therapy. The submission leverages existing clinical data from their BRIGHT trial, a capital-efficient regulatory strategy.
The company's ProCellEx plant cell-based protein expression platform continues demonstrating versatility across multiple therapeutic proteins. While their pipeline remains modest in size, it shows focused development in areas of clear unmet need. The exploration of PRX-119 suggests continued commitment to pipeline expansion, though specific details remain
The decrease in R&D expenses primarily reflects completion of the Fabry program rather than reduced innovation investment.
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL,
"2024 was a record year in revenues from selling goods for Protalix, as we experienced increases in all three of our revenue streams, Chiesi, Pfizer and
Fiscal Year 2024 and Recent Business Highlights
Pipeline and Clinical Developments
- In 2024, we successfully completed the First-in-Human (FIH) phase I clinical trial of PRX-115, our recombinant PEGylated uricase product candidate in development as a potential treatment for uncontrolled gout. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD; reduction of uric acid) following a single dose of PRX-115 in subjects with elevated uric acid levels.
- The results of the FIH study demonstrate that PRX-115 has the potential to offer an effective uric acid-lowering treatment with an added benefit of a potentially wide dosing interval, which may enhance patient compliance and treatment flexibility. Further studies are needed to confirm the long-term safety and efficacy of PRX-115 in the gout patient population.
- The results were presented in a late-breaking poster at the American College of Rheumatology (ACR) Convergence 2024, being held November 14-19, 2024 at the Walter E. Washington Convention Center in
Washington, D.C. A copy of the poster is available on the Protalix website here: https://protalix.com/sites/default/files/PRX-115_SAD_Poster_ACR_2024_4Nov2024.pdf. - In June 2024, we hosted an Investor Day highlighting current treatment landscapes and clinical results for Fabry disease and uncontrolled gout. The event featured presentations from key opinion leaders (KOLs) Aleš Linhart, D.Sc., FESC (Charles University,
Prague ) and Naomi Schlesinger, M.D. (University ofUtah ). Our leadership also provided insight into our strategy and future plans. The KOL presentation slides can be found in the Presentations section of the Protalix website: https://ir.protalix.com/news-events/presentations.
Pegunigalsidase alfa
- In December 2024, we and our global development and commercial partner, Chiesi Global Rare Diseases, announced that the European Medicines Agency (EMA) validated the Variation Submission for pegunigalsidase alfa to label a less frequent dosing regimen at a dose of 2 mg/kg administered every four weeks in adult patients with Fabry disease. The variation submission is supported by a revised Population-PK model and new exposure-response analyses, and by the clinical data on pegunigalsidase alfa 2 mg/kg every four weeks from our completed phase III BRIGHT clinical trial of pegunigalsidase alfa (PB-102-F50) and the ongoing extension study.
Corporate Developments
- In September 2024, we repaid in full all of the outstanding principal and interest payable under our then outstanding
7.50% Senior Secured Convertible Promissory Notes due September 2024. The repayment of the convertible notes at maturity was financed entirely with available cash. - Since December 31, 2024, we issued 908,000 shares of our common stock in connection with the exercise of warrants issued in 2020 generating proceeds equal to approximately
$2
Fiscal Year 2024 Financial Highlights
- We recorded revenues from selling goods of
$53.0 million $12.6 million 31% , compared to revenues of$40.4 million $11.8 million $0.6 million Brazil and an increase of$0 - We recorded revenues from license and R&D services of
$0.4 million $24.7 million 98% , compared to revenues of$25.1 million $20 the United States and the European Union in May 2023, from the completion of the regulatory processes related to the review of the Biologics License Application (BLA) and the Marketing Authorization Application (MAA) for Elfabrio by the FDA and EMA, respectively. As a result of the completion of the Fabry clinical program in 2023, we expect to generate minimal revenues from license and R&D services other than potential regulatory and commercial milestone payments. - Cost of goods sold was
$24.3 million $1.3 million 6% , compared to cost of goods sold of$23.0 million - For the year ended December 31, 2024, our total research and development expenses were approximately
$13.0 million $7.1 million $2.4 million $0.9 million $2.6 million $17.1 million $7.8 million $6.3 million $0.6 million $2.4 million $4.1 million 24% , for the year ended December 31, 2024 compared to the year ended December 31, 2023. The decrease in research and development expenses resulted primarily from the completion of our Fabry clinical program and the regulatory processes related to the BLA and MAA review of Elfabrio by the applicable regulatory agencies. - Selling, general and administrative expenses were
$12.2 million $2.8 million 19% , from$15.0 million $1.8 million $1.0 million - Financial income, net was
$0.2 million $1.9 million $1.4 million $0.7 million - For the year ended December 31, 2024, we recorded income taxes of approximately
$1.2 million $0.9 million 300% , compared to income taxes of$0.3 million U.S. Tax Cuts and Jobs Act, or the TCJA. Effective in 2022, Section 174 of the TCJA requires allU.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over five years for research activities conducted inthe United States and over 15 years for research activities conducted outside ofthe United States rather than deducting such costs in the current year. - Cash, cash equivalents and short-term bank deposits were approximately
$34.8 million - Net income for the year ended December 31, 2024 was approximately
$2.9 million $0.04 $8.3 million $0.12 $0.09
Conference Call and Webcast Information
We will host a conference call today, March 17, 2025, at 8:30 am EDT, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date: Monday, March 17, 2025
Time: 8:30 a.m. Eastern Daylight Time (EDT)
Toll Free: 1-877-423-9813
International: 1-201-689-8573
Israeli Toll Free: 1-809-406-247
Conference ID: 13752080
Call me™: https://tinyurl.com/yey23rkc
The Call me™ feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away.
Webcast Details:
The conference will be webcast live from the Protalix website and will be available via the following links:
Company Link: https://ir.protalix.com/news-events/events
Webcast Link: https://tinyurl.com/yjfybd5t
Conference ID: 13752080
Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.
A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Protalix website, at the above link.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain
Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX–119, a plant cell-expressed long acting DNase I for the treatment of NETs-related diseases; and others.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the FDA) approval received for the product; the possible disruption of our operations due to the war declared by
Investor Contact
Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
PROTALIX BIOTHERAPEUTICS, INC. | ||||||
CONSOLIDATED BALANCE SHEETS | ||||||
( | ||||||
December 31, | ||||||
2023 | 2024 | |||||
ASSETS | ||||||
CURRENT ASSETS: | ||||||
Cash and cash equivalents | $ | 23,634 | $ | 19,760 | ||
Short-term bank deposits | 20,926 | 15,070 | ||||
Accounts receivable – Trade | 5,272 | 2,909 | ||||
Other assets | 1,055 | 1,096 | ||||
Inventories | 19,045 | 21,243 | ||||
Total current assets | $ | 69,932 | $ | 60,078 | ||
NON-CURRENT ASSETS: | ||||||
Funds in respect of employee rights upon retirement | $ | 528 | $ | 462 | ||
Property and equipment, net | 4,973 | 4,591 | ||||
Deferred income tax asset | 3,092 | 2,856 | ||||
Operating lease right of use assets | 5,909 | 5,430 | ||||
Total assets | $ | 84,434 | $ | 73,417 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES: | ||||||
Accounts payable and accruals: | ||||||
Trade | $ | 4,320 | $ | 4,533 | ||
Other | 19,550 | 19,588 | ||||
Operating lease liabilities | 1,409 | 1,500 | ||||
Convertible notes | 20,251 | — | ||||
Total current liabilities | $ | 45,530 | $ | 25,621 | ||
LONG TERM LIABILITIES: | ||||||
Liability for employee rights upon retirement | 714 | $ | 559 | |||
Operating lease liabilities | 4,621 | 4,026 | ||||
Total long term liabilities | $ | 5,335 | $ | 4,585 | ||
Total liabilities | $ | 50,865 | $ | 30,206 | ||
COMMITMENTS | ||||||
STOCKHOLDERS' EQUITY | ||||||
Common Stock, | 73 | 76 | ||||
Additional paid-in capital | 415,045 | 421,528 | ||||
Accumulated deficit | (381,549) | (378,393) | ||||
Total stockholders' equity | 33,569 | 43,211 | ||||
Total liabilities and stockholders' equity | $ | 84,434 | $ | 73,417 | ||
PROTALIX BIOTHERAPEUTICS, INC. | |||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
( | |||||||||
Year Ended December 31, | |||||||||
2022 | 2023 | 2024 | |||||||
REVENUES FROM SELLING GOODS | $ | 25,292 | $ | 40,418 | $ | 52,981 | |||
REVENUES FROM LICENSE AND R&D SERVICES | 22,346 | 25,076 | 418 | ||||||
TOTAL REVENUE | 47,638 | 65,494 | 53,399 | ||||||
COST OF GOODS SOLD | (19,592) | (22,982) | (24,319) | ||||||
RESEARCH AND DEVELOPMENT EXPENSES | (29,349) | (17,093) | (12,970) | ||||||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (11,711) | (14,959) | (12,193) | ||||||
OPERATING INCOME (LOSS) | (13,014) | 10,460 | 3,917 | ||||||
FINANCIAL EXPENSES | (2,529) | (3,180) | (1,062) | ||||||
FINANCIAL INCOME | 1,146 | 1,286 | 1,299 | ||||||
FINANCIAL INCOME (EXPENSES), NET | (1,383) | (1,894) | 237 | ||||||
INCOME (LOSS) BEFORE TAXES ON INCOME | (14,397) | 8,566 | 4,154 | ||||||
TAXES ON INCOME | (530) | (254) | (1,222) | ||||||
NET INCOME (LOSS) | $ | (14,927) | $ | 8,312 | $ | 2,932 | |||
EARNINGS (LOSS) PER SHARE OF COMMON STOCK: | |||||||||
BASIC | $ | (0.31) | $ | 0.12 | $ | 0.04 | |||
DILUTED | $ | (0.31) | $ | 0.09 | $ | 0.04 | |||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK | |||||||||
USED IN COMPUTING EARNINGS (LOSS) PER SHARE: | |||||||||
BASIC | 48,472,159 | 67,512,527 | 72,530,698 | ||||||
DILUTED | 48,472,159 | 82,424,016 | 81,057,176 | ||||||
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SOURCE Protalix BioTherapeutics, Inc.
FAQ
What was PLX's revenue growth in fiscal year 2024?
How much cash does Protalix (PLX) have as of December 2024?
What progress did PLX make with their gout treatment candidate in 2024?
What regulatory milestone did PLX achieve for pegunigalsidase alfa in December 2024?
