Protalix BioTherapeutics Reports Second Quarter 2024 Financial and Business Results
Protalix BioTherapeutics (NYSE American: PLX) reported Q2 2024 financial results and provided a business update. Key highlights include:
- Revenues from selling goods decreased 12% to $13.3 million
- License and R&D services revenue fell 99% to $0.2 million
- Net loss of $2.2 million ($0.03 per share) compared to net income of $19.3 million in Q2 2023
- Cash position of $45 million as of June 30, 2024
- Positive topline results from Phase I trial of PRX-115 for uncontrolled gout
- Preparations initiated for Phase II trial of PRX-115
The company's pipeline progress and strong balance sheet position it to repay convertible notes due September 2024 while maintaining operations.
Protalix BioTherapeutics (NYSE American: PLX) ha riportato i risultati finanziari del secondo trimestre del 2024 e fornito un aggiornamento aziendale. I principali punti salienti includono:
- I ricavi dalla vendita di beni sono diminuiti del 12% a 13,3 milioni di dollari
- I ricavi da licenze e servizi di R&D sono diminuiti del 99% a 0,2 milioni di dollari
- La perdita netta è stata di 2,2 milioni di dollari (0,03 dollari per azione) rispetto a un utile netto di 19,3 milioni di dollari nel secondo trimestre del 2023
- Posizione di liquidità di 45 milioni di dollari al 30 giugno 2024
- Risultati positivi ottenuti dal trial di Fase I di PRX-115 per la gotta non controllata
- Sono state avviate le preparazioni per il trial di Fase II di PRX-115
I progressi nel pipeline dell'azienda e un forte bilancio la posizionano per rimborsare i titoli convertibili in scadenza a settembre 2024, mantenendo le operazioni.
Protalix BioTherapeutics (NYSE American: PLX) informó sobre los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización empresarial. Los aspectos más destacados incluyen:
- Los ingresos por la venta de bienes cayeron un 12% a 13,3 millones de dólares
- Los ingresos por licencias y servicios de I+D disminuyeron en un 99% a 0,2 millones de dólares
- La pérdida neta fue de 2,2 millones de dólares (0,03 dólares por acción) en comparación con una ganancia neta de 19,3 millones de dólares en el segundo trimestre de 2023
- Posición de efectivo de 45 millones de dólares al 30 de junio de 2024
- Resultados positivos de la fase I del ensayo de PRX-115 para la gota no controlada
- Se iniciaron los preparativos para el ensayo de fase II de PRX-115
El progreso del pipeline de la compañía y un sólido balance la posicionan para reembolsar los pagarés convertibles que vencen en septiembre de 2024 mientras mantienen sus operaciones.
Protalix BioTherapeutics (NYSE American: PLX)가 2024년 2분기 재무 결과를 발표하고 사업 업데이트를 제공했습니다. 주요 사항은 다음과 같습니다:
- 상품 판매에서 발생한 수익이 12% 감소하여 1,330만 달러에 달했습니다
- 라이센스 및 연구개발 서비스 수익이 99% 감소하여 20만 달러에 그쳤습니다
- 순손실이 220만 달러(주당 0.03달러)로, 2023년 2분기 순이익 1,930만 달러와 비교되었습니다
- 2024년 6월 30일 기준 현금 보유액이 4,500만 달러입니다
- 조절되지 않는 통풍을 위한 PRX-115의 1상 시험에서 긍정적인 결과가 나왔습니다
- PRX-115의 2상 시험을 위한 준비가 시작되었습니다
회사의 파이프라인 진행 상황과 강력한 재무 상태는 2024년 9월 만기인 전환사채를 상환하면서 운영을 유지하는 데 유리한 위치에 있습니다.
Protalix BioTherapeutics (NYSE American: PLX) a publié les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour sur l'activité. Les points clés incluent :
- Les revenus issus de la vente de biens ont diminué de 12 % pour atteindre 13,3 millions de dollars
- Les revenus des licences et des services de R&D ont chuté de 99 % pour s'établir à 0,2 million de dollars
- La perte nette s'est élevée à 2,2 millions de dollars (0,03 dollar par action) par rapport à un bénéfice net de 19,3 millions de dollars au deuxième trimestre 2023
- Position de trésorerie de 45 millions de dollars au 30 juin 2024
- Résultats positifs de l'essai de phase I de PRX-115 pour la goutte non contrôlée
- Préparations lancées pour l'essai de phase II de PRX-115
Les progrès du pipeline de l'entreprise et la solidité de son bilan la positionnent pour rembourser les obligations convertibles arrivant à échéance en septembre 2024 tout en maintenant ses opérations.
Protalix BioTherapeutics (NYSE American: PLX) hat die finanziellen Ergebnisse des zweiten Quartals 2024 veröffentlicht und ein Unternehmensupdate gegeben. Wichtige Highlights sind:
- Die Einnahmen aus dem Verkauf von Waren sanken um 12% auf 13,3 Millionen US-Dollar
- Die Einnahmen aus Lizenzen und F&E-Dienstleistungen fielen um 99% auf 0,2 Millionen US-Dollar
- Der Nettoverlust betrug 2,2 Millionen US-Dollar (0,03 US-Dollar pro Aktie) im Vergleich zu einem Nettogewinn von 19,3 Millionen US-Dollar im zweiten Quartal 2023
- Die Zahlungsmittelposition betrug zum 30. Juni 2024 45 Millionen US-Dollar
- Positive Ergebnisse aus der Phase-I-Studie von PRX-115 für unkontrollierte Gicht
- Vorbereitungen für die Phase-II-Studie von PRX-115 wurden eingeleitet
Der Fortschritt der Pipeline und die solide Bilanz positionieren das Unternehmen, um die im September 2024 fälligen Wandelschuldverschreibungen zurückzuzahlen und gleichzeitig die Betriebsabläufe aufrechtzuerhalten.
- Positive topline results from Phase I trial of PRX-115 for uncontrolled gout
- Initiated preparations for Phase II trial of PRX-115
- Strong cash position of $45 million as of June 30, 2024
- Ability to repay convertible notes due September 2024 while maintaining operations
- Increase in sales to Brazil ($4.7 million) and Pfizer ($3.5 million)
- Revenues from selling goods decreased 12% to $13.3 million
- License and R&D services revenue fell 99% to $0.2 million
- Net loss of $2.2 million in Q2 2024 compared to net income of $19.3 million in Q2 2023
- Cost of goods sold increased 56% to $9.5 million
- Decrease of $10.0 million in sales to Chiesi
Insights
Protalix's Q2 2024 results reveal a mixed financial picture. Revenue from goods decreased by
The company's cost of goods sold increased by
While Protalix reported a net loss of
The progress in Protalix's early-stage pipeline, particularly PRX-115 for uncontrolled gout, is promising. The positive topline results from the First-in-Human Phase I clinical trial demonstrate rapid and long-lasting reduction of plasma uric acid concentrations, dose-dependent increase in exposure and a favorable tolerability profile. These outcomes are important for gout treatment, where maintaining low uric acid levels is key to managing the disease.
The completion of dosing in the eighth and highest dose cohort, with full trial results expected in Q3 2024, could be a significant milestone. If the positive trend continues, it may pave the way for the planned Phase II clinical trial in uncontrolled gout patients. This progression through clinical stages is critical for potential future commercialization.
The company's ProCellEx® plant cell-based protein expression system continues to demonstrate its versatility in developing recombinant therapeutic proteins. This proprietary technology could provide Protalix with a competitive edge in biopharmaceutical development, potentially leading to a diverse pipeline of novel therapies for various indications beyond Fabry disease and gout.
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL,
"In the second quarter, Protalix has made meaningful progress on our early-stage pipeline," said Dror Bashan, Protalix's President and Chief Executive Officer. "Results from the first seven cohorts of the phase I clinical trial of PRX-115 for the treatment of uncontrolled gout are encouraging, and we anticipate topline results from all eight cohorts to be available in the third quarter of 2024. Based on the safety results to date, we have initiated preparations for a phase II clinical trial of PRX-115 in uncontrolled gout patients. Our strong balance sheet enables repayment of our convertible notes due September 2024 while maintaining ongoing operations and executing on our corporate strategy."
Second Quarter 2024 and Recent Business Highlights
Pipeline Developments
- In May 2024, the Company announced positive topline results from the First-in-Human (FIH) Phase I clinical trial of PRX-115, the Company's a recombinant PEGylated uricase product candidate in development as a potential treatment for uncontrolled gout.
o Results from the first seven dosing cohorts demonstrated that single administration of PRX-115 induced rapid, long-lasting reduction of plasma uric acid concentrations, a dose-dependent increase in exposure, and a favorable tolerability profile.
o Dosing of the eighth and highest dose cohort is complete, and topline results from the full trial are expected in the third quarter of 2024.
- In June 2024, the Company 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 ). The Company's leadership also provided insight into its strategy and future plans. A replay of the event can be accessed here: https://ir.protalix.com/events/event-details/person-investor-day-discuss-current-treatment-landscapes-and-clinical-results.
Second Quarter 2024 Financial Highlights
- The Company recorded revenues from selling goods of
during the three months ended June 30, 2024, a decrease of$13.3 million , or$1.8 million 12% , compared to revenues of for the three months ended June 30, 2023. The decrease resulted primarily from a decrease of$15.1 million in sales to Chiesi, partially offset by an increase of$10.0 million .7 million in sales to$4 Brazil and an increase of .5 million in sales to Pfizer. Sales to Chiesi in the three months ended June 30, 2023 were in connection with the commercial launch and inventory buildup of Elfabrio® after its approval for marketing in$3 the United States and the European Union. The increases in sales toBrazil and Pfizer during the three months ended June 30, 2024 resulted primarily from the timing of delivery. - The Company recorded revenues from license and R&D services of
for the three months ended June 30, 2024, a decrease of$0.2 million , or$19.8 million 99% , compared to revenues of for the three months ended June 30, 2023. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with the Chiesi Agreements. The revenues from license and R&D services for the three months ended June 30, 2023 were the result of the$20.0 million .0 million regulatory milestone payment from Chiesi in connection with the FDA approval of Elfabrio granted during that period.$20 - Cost of goods sold was
for the three months ended June 30, 2024, an increase of$9.5 million , or$3.4 million 56% , from cost of goods sold of for the three months ended June 30, 2023. The increase in cost of goods sold was primarily the result of an increase in sales to Pfizer and to$6.1 million Brazil . In addition, during the three months ended June 30, 2023, a significantly higher portion of the costs for certain drug substance sold, as compared to the three months ended June 30, 2024, were recognized as research and development expenses, not cost of goods sold, as such drug substance was produced as part of the Company's research and development activities. - For the three months ended June 30, 2024, the Company's total research and development expenses were approximately
comprised of approximately$3.0 million in subcontractor-related expenses, approximately$0.5 million of salary and related expenses, approximately$1.6 million of materials-related expenses and approximately$0.2 million of other expenses. For the three months ended June 30, 2023, the Company's total research and development expenses were approximately$0.7 million comprised of approximately$4.5 million of subcontractor-related expenses, approximately$1.7 million of salary and related expenses, approximately$2.0 million of materials-related expenses and approximately$0.1 million of other expenses. Total decrease in research and developments expenses for the three months ended June 30, 2024 was$0.7 million , or$1.5 million 33% , compared to the three months ended June 30, 2023. The decrease in research and development expenses resulted primarily from the completion of the Company's Fabry clinical program and the regulatory processes related to the review of the Elfabrio Biologics License Application (BLA) inthe United States and the Marketing Authorization Application (MAA) in the European Union by the applicable regulatory agencies. - Selling, general and administrative expenses were
for the three months ended June 30, 2024, a decrease of$3.5 million , or$0.5 million 13% , compared to for the three months ended June 30, 2023. The decrease resulted primarily from a decrease of$4.0 million in salary and related expenses.$0.5 million - Financial income, net were
for the three months ended June 30, 2024, compared to financial expenses, net of$0.2 million for the three months ended June 30, 2023. The difference resulted primarily from higher interest income on bank deposits and lower notes interest expenses due to notes conversions executed in 2023.$0.8 million - For the three months ended June 30, 2024, the Company recorded a tax benefit of approximately
, compared to income taxes of$0.1 million for the three months ended June 30, 2023. Income taxes recorded are primarily the result of the provision for current taxes in respect of Section 174 of the U.S. Tax Cuts and Jobs Act, which was enacted in December 2017.$0.3 million - Cash, cash equivalents and short-term bank deposits were approximately
at June 30, 2024.$45.0 million - Net loss for the three months ended June 30, 2024 was approximately
.2 million, or$2 .03 per share, basic and diluted, compared to a net income of$0 .3 million, or$19 per share, basic, and$0.29 per share, diluted, for the same period in 2023.$0.21 - Since the end of the quarter ended June 30, 2024, the Company collected approximately
in the aggregate from sales to Pfizer Inc., and approximately$4.6 million from sales to$2.3 million Brazil .
Conference Call and Webcast Information
The Company will host a conference call today, August 14, 2024 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: Wednesday, August 14, 2024
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: 13747744
Call me™: https://tinyurl.com/2n9fhumh
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:
Company Link: https://ir.protalix.com/news-events/events
Webcast Link: https://tinyurl.com/yb6bu7vs
Conference ID: 13747744
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 Company's 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 U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in
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 action 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 "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," 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
PROTALIX BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS ( (Unaudited)
| |||||||
June 30, 2024 | December 31, 2023 | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 23,399 | $ | 23,634 | |||
Short-term bank deposits | 21,630 | 20,926 | |||||
Accounts receivable – Trade | 10,126 | 5,272 | |||||
Other assets | 1,493 | 1,055 | |||||
Inventories | 20,719 | 19,045 | |||||
Total current assets | $ | 77,367 | $ | 69,932 | |||
NON-CURRENT ASSETS: | |||||||
Funds in respect of employee rights upon retirement | $ | 535 | $ | 528 | |||
Property and equipment, net | 4,609 | 4,973 | |||||
Deferred income tax asset | 3,299 | 3,092 | |||||
Operating lease right of use assets | 5,730 | 5,909 | |||||
Total assets | $ | 91,540 | $ | 84,434 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable and accruals: | |||||||
Trade | $ | 4,064 | $ | 4,320 | |||
Other | 19,343 | 19,550 | |||||
Operating lease liabilities | 1,450 | 1,409 | |||||
Contracts liability | 12,695 | - | |||||
Convertible notes | 20,420 | 20,251 | |||||
Total current liabilities | $ | 57,972 | $ | 45,530 | |||
LONG TERM LIABILITIES: | |||||||
Liability for employee rights upon retirement | $ | 705 | $ | 714 | |||
Operating lease liabilities | 4,282 | 4,621 | |||||
Total long term liabilities | $ | 4,987 | $ | 5,335 | |||
Total liabilities | $ | 62,959 | $ | 50,865 | |||
COMMITMENTS | |||||||
STOCKHOLDERS' EQUITY | 28,581 | 33,569 | |||||
Total liabilities and stockholders' equity | $ | 91,540 | $ | 84,434 |
PROTALIX BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ( (Unaudited)
| ||||||||||||
Six Months Ended | Three Months Ended | |||||||||||
June 30, 2024 | June 30, 2023 | June 30, 2024 | June 30, 2023 | |||||||||
REVENUES FROM SELLING GOODS | $ | 16,981 | $ | 20,141 | $ | 13,304 | $ | 15,075 | ||||
REVENUES FROM LICENSE AND R&D SERVICES | 241 | 24,522 | 170 | 20,000 | ||||||||
TOTAL REVENUE | 17,222 | 44,663 | 13,474 | 35,075 | ||||||||
COST OF GOODS SOLD | (12,058) | (9,233) | (9,456) | (6,148) | ||||||||
RESEARCH AND DEVELOPMENT EXPENSES | (5,848) | (10,322) | (2,961) | (4,475) | ||||||||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (6,599) | (7,146) | (3,484) | (4,031) | ||||||||
OPERATING INCOME (LOSS) | (7,283) | 17,962 | (2,427) | 20,421 | ||||||||
FINANCIAL EXPENSES | (757) | (2,169) | (367) | (1,305) | ||||||||
FINANCIAL INCOME | 1,035 | 918 | 522 | 531 | ||||||||
FINANCIAL INCOME (EXPENSES), NET | 278 | (1,251) | 155 | (774) | ||||||||
INCOME (LOSS) BEFORE TAX BENEFIT (TAXES ON INCOME) | (7,005) | 16,711 | (2,272) | 19,647 | ||||||||
TAX BENEFIT (TAXES ON INCOME) | 207 | (503) | 69 | (308) | ||||||||
NET INCOME (LOSS) FOR THE PERIOD | $ | (6,798) | $ | 16,208 | $ | (2,203) | $ | 19,339 | ||||
EARNINGS (LOSS) PER SHARE OF COMMON STOCK: | ||||||||||||
BASIC | $ | (0.09) | $ | 0.26 | $ | (0.03) | $ | 0.29 | ||||
DILUTED | $ | (0.09) | $ | 0.18 | $ | (0.03) | $ | 0.21 | ||||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK | ||||||||||||
USED IN COMPUTING EARNINGS (LOSS) PER SHARE: | ||||||||||||
BASIC | 73,172,980 | 62,378,745 | 73,308,281 | 67,158,628 | ||||||||
DILUTED | 73,172,980 | 78,896,220 | 73,308,281 | 83,200,641 |
Investor Contact
Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
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SOURCE Protalix BioTherapeutics, Inc.
FAQ
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