Protalix Biotherapeutics reports record revenue in 2024, advances gout treatment candidate
Protalix Biotherapeutics Inc (NYSE-A:PLX) reported record revenue from product sales in 2024, driven by growth across all major commercial partnerships, and provided updates on its clinical pipeline, including a promising gout treatment candidate. The biopharmaceutical company recorded $53 million in product revenue for the year ended December 31, 2024, a 31% increase from $40.4 million in 2023, with gains from sales to Chiesi, Pfizer, and Brazil.
Protalix BioTherapeutics Says With Debt Fully Repaid, It's Well-Positioned To Execute Strategy Through 2025 And Beyond
On Monday, Protalix BioTherapeutics, Inc. PLX reported fiscal 2024 earnings of 4 cents, beating the consensus of 1 cent.
Protalix BioTherapeutics, Inc. (PLX) Q4 2024 Earnings Call Transcript
Protalix BioTherapeutics, Inc. (NYSE:PLX ) Q4 2024 Earnings Conference Call March 17, 2025 8:30 AM ET Company Participants Mike Moyer - Investor Relations, LifeSci Advisors Dror Bashan - President and Chief Executive Officer Eyal Rubin - Senior Vice President and Chief Financial Officer Conference Call Participants Ram Selvaraju - H.C. Wainwright John Vandermosten - Zach's SCR Operator Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Fiscal Year 2024 Financial and Business Results Conference Call.
Protalix Biotherapeutics poised for profitability as rare disease drug gains momentum
For a small biotech company, Protalix Biotherapeutics Inc (NYSE-A:PLX) is making a big impression with analysts and investors by targeting rare diseases with cutting-edge treatments. The New Jersey- and Israel-based company has emerged as a biotech underdog with strong tailwinds that analysts at HC Wainwright and Zacks Small Cap Research believe puts it the brink of sustainable profitability.
Protalix Biotherapeutics gains momentum in the rare disease space: analysts
Protalix Biotherapeutics Inc (NYSE-A:PLX) has received bullish assessments from analysts at HC Wainwright and Zacks Small Cap Research, who see sustainable profitability on the horizon. Strong revenue growth from its flagship Fabry disease treatment, Elfabrio, and a robust pipeline have prompted price target increases, with HC Wainwright raising its outlook to $15 per share and Zacks maintaining a valuation of $14.
Protalix BioTherapeutics, Inc. (PLX) Q3 2024 Earnings Call Transcript
Protalix BioTherapeutics, Inc. (NYSE:PLX ) Q3 2024 Results Earnings Conference Call November 14, 2024 8:30 AM ET Company Participants Mike Moyer - Investor Relations, LifeSci Advisors Dror Bashan - President and Chief Executive Officer Eyal Rubin - Senior Vice President and Chief Financial Officer Conference Call Participants John Vandermosten - Zacks Investment Research Daniel Smith - H.C. Wainwright & Co., LLC Robert Sassoon - Water Tower Research Operator Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Third Quarter 2024 Financial and Business Results Conference Call.
Protalix BioTherapeutics, Inc. (PLX) Q2 2024 Earnings Call Transcript
Protalix BioTherapeutics, Inc. (NYSE:PLX ) Q2 2024 Earnings Conference Call August 14, 2024 8:30 AM ET Company Participants Mike Moyer - Managing Director, LifeSci Advisors Dror Bashan - President and CEO Eyal Rubin - SVP and CFO Conference Call Participants John Vandermosten - Zacks Small Cap Research Unidentified Analyst - H.C. Wainwright Operator Good morning, ladies and gentlemen and welcome to the Protalix BioTherapeutics Second Quarter 2024 Financial and Business Results Conference Call.
SHAREHOLDER ALERT: Kaskela Law LLC Announces Investigation of Protalix BioTherapeutics, Inc. (NYSE: PLX) and Encourages Investors to Contact the Firm
PHILADELPHIA, PA / ACCESSWIRE / June 11, 2024 / Kaskela Law LLC announces that it is investigating Protalix BioTherapeutics, Inc. (NYSE:PLX) ("Protalix") on behalf of the company's shareholders. Since May 2023, shares of Protalix common stock have declined in value from a trading price of approximately $3.25 per share to a current trading price of below $1.25 per share, a decline of over 61% in value.
Protalix BioTherapeutics : PLX Corporate Presentation (May 2024)
PROTALIX BIOTHERAPEUTICS C O R P O R A T E P R E S E N T A T I O N M a y 2 0 2 4 Disclaimers Third-Party Information This presentation also contains estimates and other data made by independent parties and Protalix relating to market size and growth and other data related to the industry in which Protalix operates. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Neither Protalix nor any other person makes any representation as to the accuracy or completeness of such data. In light of the foregoing, you are urged not to rely on any forward-looking statement or third-party data in reaching any conclusion or making any investment decision about any securities of the Company. The appropriateness of a particular investment or strategy will depend on an investor's individual circumstances and objectives. We recommend that investors independently evaluate specific investments and strategies. Corporate Presentation I May 2024 2 Forward-Looking Statements This presentation contains forward-looking statements that involve risks and uncertainties within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management's current expectations or plans projections for future operating and financial performance based on assumptions currently believed to be valid. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" and other words or phrases of similar import, as they relate to Protalix, its subsidiaries or its management, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements in this presentation include, among other things, statements regarding our cash runway and the commercialization of our product. Forward-looking statements are subject to many risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; Elfabrio's revenue, expenses and costs may not be as expected; Elfabrio's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the U.S. Food and Drug Administration, or the FDA, approval received for the product; the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the potential commercial value of our products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer Inc., and Chiesi; the amount and sufficiency of our cash and cash equivalents; and other factors described in our filings with the U.S. Securities and Exchange Commission. In addition, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Given these uncertainties, investors should not place undue reliance on these forward-looking statements. Except as required by law, Protalix undertakes no obligation to update or revise the information contained in this presentation whether as a result of new information, future events or circumstances or otherwise. Corporate Presentation I May 2024 3 Investment Highlights A strong foundation to further expand into the Rare Disease space Two Approved Drugs Elelyso® (alfataliglicerase in Brazil): FDA approved, commercially marketed drug for Gaucher disease. Elfabrio® (pegunigalsidase alfa) has been approved for marketing by the FDA and the European Commission for Fabry disease.(1) Clinically-Validated Platforms Proprietary ProCellEx® platform for recombinant protein expression cGMP(2) manufacturing facility successfully inspected and audited by multiple regulatory agencies, including the FDA & EMA. Strong Partnerships Chiesi Farmaceutici S.p.A. Pfizer Inc. Fundação Oswaldo Cruz (Fiocruz) Clinical and Regulatory Expertise in Rare Genetic Space Strong clinical and regulatory expertise for biologics and world-class network of Lysosomal Storage Disorder disease experts. Development Pipeline Uricase (PRX-115) for the treatment of severe gout. Long Acting DNase I (PRX-119) for the treatment of NETs-related diseases, as well as other product candidates, in discovery and preclinical phases. Revenue-Generating Multiple revenue streams, including sales to Pfizer, Fiocruz (Brazil) and Chiesi. For the treatment of adult patients with Fabry disease cGMP = Current Good Manufacturing Practice Corporate Presentation I May 2024 4 Product Pipeline Recombinant proteins designed to have potentially improved therapeutic profiles that target unmet medical needs and established pharmaceutical markets Discovery and Preclinical Phase I Phase II Phase III Marketing Application Elelyso® Gaucher Disease Approved in 23 markets (taliglucerase alfa) Elfabrio® Fabry Disease Approved (US and EU) (pegunigalsidase alfa) PEGylated Uricase (PRX-115) Uncontrolled Gout Expanding to 8th cohort; phase II planning in progress Long Acting (LA) DNase I NETs-Related (PRX-119) Diseases Research Programs Rare Diseases Note: Current pipeline candidates are generally recombinant proteins expressed via our proprietary ProCellEx® system Corporate Presentation I May 2024 5 Elelyso® for Gaucher Disease First plant cell derived recombinant protein approved by the FDA Gaucher Disease Rare autosomal recessive disorder: affects 1 in 40,000 people Glucocerebrosidase (GCD) enzyme deficiency resulting in accumulation of glucosylceramide, a lipid, in bone marrow, lungs, spleen, liver and sometimes brain Product • Elelyso (alfataliglicerase in Brazil) is a proprietary, recombinant form of GCD for long-term treatment of patients with a confirmed diagnosis of type 1 Gaucher disease Expressed through our ProCellEx® platform Symptoms and Treatment Possible symptoms include enlarged liver and spleen, various bone disorders, easy bruising and bleeding and anemia Left untreated, it can cause permanent body damage and decreased life expectancy Standard of Care: Enzyme Replacement Therapy Commercial Potential Approved in 23 markets Worldwide exclusive license agreement with Pfizer in 2009, amended in 2015 (excluding Brazil) Sales ~$10.4M in Brazil (FY2023) via Fundação Oswaldo Cruz Market share in Brazil: ~27% 1. Approved in 23 markets including the US, Australia, Canada, Israel, Brazil, Russia and Turkey. In 2010, the European Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion but also concluded that the medicine cannot be granted marketing authorization in the EU because of the market exclusivity that had been granted to Vpriv® (Shire), which was authorized in August 2010, for the same condition. The orphan market exclusivity expired in August 2022. Corporate Presentation I May 2024 6 Elfabrio® for Fabry Disease Second plant cell derived recombinant protein approved by the FDA Fabry Disease Rare X-linked disease: affecting about one in every 40,000 to 60,000 men worldwide α-galactosidase-Aenzyme deficiency leads to accumulation of the fatty substance globotriaosylceramide (Gb3) in blood and blood vessel walls throughout the body Symptoms and Treatment Progressive disease that can lead to renal failure, cardiomyopathy with potentially malignant cardiac arrhythmias, and strokes Symptoms such as abdominal and neuropathic pain can appear in patients as young as two years old Standard of Care: Enzyme Replacement Therapy (Replagal® or Fabrazyme®1,2) Product Elfabrio (pegunigalsidase alfa): Chemically Modified, Plant Cell Derived, PEGylated, Covalently Linked Homodimer Approved for marketing by the EC, FDA and others Expressed through our ProCellEx® platform Commercial Potential Fabry: ~$2B (2023) expected to reach ~$3.1B (2030) Poised to capture significant global market share (15-20%) Will potentially be entitled to $120M-$150Mroyalties per year from Chiesi3 Does not include Galafold®, a small molecule drug indicated for adult Fabry patients with an amenable GLA variant. Replagal® is not approved in the U.S. Based on projected 20-25% share of projected market size increase to ~$3.1 billion by 2030. Corporate Presentation I May 2024 7 Fabry Disease Competitive Landscape ~$2B market (2023) expected to reach over $3.1B (2030), CAGR of 6.8% Product Name Fabrazyme® Replagal® Galafold® Elfabrio® Parent Company Mechanism ERT ERT Pharmacological chaperone ERT Approved for Adults and pediatric patients 2+ Adults (E.U. only) Accelerated approval in adults Adults (U.S., E.U. and others) years (U.S.); (U.S.) Adults, children and adolescents aged 8+ years. (E.U.) Adults and adolescents 16+ years (E.U.) Dosing 1 mg/kg every 2 weeks 0.2 mg/kg every 2 weeks 123 mg every other day 1 mg/kg every 2 weeks Administration Intravenous infusions Intravenous infusions Oral Intravenous infusions mode Approval Date Full approval in 2021; accelerated approval in 2003 (U.S.); 2001 Not approved in U.S.; 2001 (E.U.) 2018 (U.S.); 2016 (E.U.) 2023 (U.S. and E.U.) (E.U.) Elfabrio is poised to capture meaningful global market share (15-20%) Corporate Presentation I May 2024 8 Committed Commercial Partner Global Partnership with Chiesi Farmaceutici S.p.A. International research-focused biopharmaceutical group with sales in excess of $3B in 2023 (reflecting 10% growth year-on-year Operating in close to 30 countries with over 7,000 employees Strong sales and marketing partner poised to maximize the market potential of pegunigalsidase alfa as the centerpiece of their new strategic U.S.-based Orphan Drug division • Committed global partner with experienced sales team Strategic focus on rare diseases Specific expertise in Fabry disease Ideally suited to bring Elfabrio® to patients with Fabry disease(1) (1) Tiered royalties of 15-35%(ex-U.S.);15-40% (U.S.) Corporate Presentation I May 2024 9 Gout Most Common Inflammatory Arthritis Accumulation of Excess Uric Acid Systemic Disease Currently Available Therapies Gout affects approximately 14 million people in the U.S. ~5% (estimated) of the gout population is considered to have chronic refractory gout Hyperuricemia leads to deposition of monosodium urate crystals (tophi) in joints, tendons and other tissues Triggers recurrent episodes of pronounced acute inflammation, known as gout flares Gout flares can lead to substantial morbidity, severe pain, reduced quality of life, decreased physical function Co-morbidities associated with gout include hypertension, cardiovascular disease, renal impairment, diabetes, obesity, hyperlipidemia, and frequently in a combination known as the metabolic syndrome First-line xanthine oxidase inhibitors (XOIs): Allopurinol and Febuxostat One recombinant uricase approved for chronic gout in adult patients refractory to conventional therapy as every two-week injection: Krystexxa® 1 1 Krystexxa has a "Black Box" safety warning for anaphylaxis and infusion reactions. It is not approved for use in the E.U. Corporate Presentation I May 2024 10 Attachments Original Link Original Document Permalink DisclaimerProtalix BioTherapeutics Inc. published this content on 20 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 May 2024 02:11:03 UTC.
