PLX.AMEXProtalix Biotherapeutics, INC
10-K: Protalix BioTherapeutics Reports Profitable 2024, Advances Pipeline
Sentiment:
Annual Results
Protalix BioTherapeutics reports a profitable 2024 driven by Elfabrio and Elelyso sales, while advancing its pipeline with PRX-115 and PRX-119.
Better than expectedThe company reported a profitable year in 2024, compared to a net loss in 2022.Revenues from selling goods increased by 31% to $53.0 million in 2024.Selling, general and administrative expenses decreased by 19% to $12.2 million for the year ended December 31, 2024.
Summary
- Protalix BioTherapeutics, a commercial-stage biopharmaceutical company, reported a profitable year in 2024.
- The company's success was driven by sales of its two commercial products, Elfabrio for Fabry disease and Elelyso for Gaucher disease.
- Revenues from selling goods increased by 31% to $53.0 million in 2024, primarily due to higher sales of Elfabrio to Chiesi.
- Revenues from license and R&D services decreased significantly to $0.4 million due to the completion of the Elfabrio clinical program.
- Research and development expenses decreased by 24% to $13.0 million, reflecting the completion of the Elfabrio program.
- The company is advancing its pipeline, including PRX-115 for uncontrolled gout, with a Phase II clinical trial expected to begin in the second half of 2025.
- Protalix repaid in full all outstanding principal and interest under its 2024 Notes in September 2024.
- As of December 31, 2024, Protalix had $34.8 million in cash and cash equivalents and short-term bank deposits.
- The company believes its current cash resources are sufficient to fund operations for at least the next 12 months.
- The company is subject to risks related to its operations in Israel, including political, economic, and military conditions.
Sentiment
Score: 7
Explanation: The document presents a generally positive outlook, highlighting profitability, revenue growth, and pipeline advancement. However, it also acknowledges risks and challenges, such as competition and reliance on partners, preventing a higher score.
Positives
- The company achieved profitability in 2024.
- Sales of Elfabrio are growing, contributing significantly to revenue.
- The company is advancing its pipeline with PRX-115 and PRX-119.
- The company has a strong cash position.
- The company has repaid its 2024 Notes, reducing its debt burden.
Negatives
- Revenues from license and R&D services decreased significantly due to the completion of the Elfabrio clinical program.
- The company is subject to risks related to its operations in Israel.
- Fiocruz is not complying with the terms and conditions of the Brazil Agreement.
Risks
- The company's future performance depends heavily on the successful commercialization of Elfabrio by Chiesi.
- The company faces competition from other treatments for Fabry disease and Gaucher disease.
- The company may need to raise additional capital in the future, which may not be available on favorable terms.
- The company's operations in Israel are subject to political, economic, and military risks.
- Fiocruz is not complying with the terms and conditions of the Brazil Agreement.
Future Outlook
The company expects to continue to incur significant operating expenditures and anticipates that its expenses will increase in the foreseeable future as it seeks to in-license additional technologies, continue to undertake preclinical development and clinical trials for its current and new drug candidates, and seek regulatory approvals for its drug candidates.
Industry Context
The report provides insight into the competitive landscape of the biopharmaceutical industry, particularly in the areas of Gaucher disease, Fabry disease, and uncontrolled gout, highlighting the major players and existing therapies.
Comparison to Industry Standards
- The global market for Gaucher disease, which includes Sanofi's Cerezyme, Shire's Vpriv, and Sanofi's Cerdelga, was $1.7 billion in 2024 and is forecasted to be approximately $1.7 billion in 2025.
- The global market for Fabry disease, which includes agalsidase beta, Sanofi's Fabrazyme, agalsidase alfa, Shire's Replagal, and Amicus Therapeutics' Galafold, is forecasted to be approximately $2.3 billion in 2025 and is forecasted to grow at a CAGR of 6.6% from 2024-2030 reaching approximately $3.1 billion in annual sales in 2030.
- Krystexxa (pegloticase) is indicated for treatment of chronic gout in adult patients refractory to conventional therapy.
Corporate Governance
| Change Type | Description | Effective Date | Impact Assessment |
|---|---|---|---|
| Bylaws Amendment | The Board of Directors unanimously approved and adopted an amendment and restatement of our company Bylaws. | December 2024 | Not specified in the document. |
Related Party Transactions
- In September 2023, with the consent of the Audit Committee of the Board of Directors, the Company engaged one of its non-executive directors to advise the Company regarding business development and licensing efforts on a consultancy basis.
Stakeholder Impact
- Shareholders: The company's profitability and pipeline progress are positive for shareholders.
- Employees: The company's financial stability and growth prospects are positive for employees.
- Patients: The company's development of new treatments for rare diseases is positive for patients.
Next Steps
- Commence a phase II clinical trial of PRX-115 in the second half of 2025.
- Continue to develop treatments for rare and orphan diseases.
- Continue to work on the further development and enhancement of our ProCellEx technology.
Key Dates
| Date | Description |
|---|---|
| 1948 | Establishment of Israel. |
| 1959 | Law for the Encouragement of Capital Investments, 1959. |
| 1969 | Law for the Encouragement of Industry (Taxes), 1969. |
| 1983 | Orphan Drug Act of 1983. |
| 1984 | Encouragement of Industrial Research, Development and Technology Innovation Law, 1984. |
| 1984 | Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). |
| 1992-04 | Protalix BioTherapeutics, Inc. originally incorporated in Florida. |
| 1993 | Protalix Ltd. incorporated in Israel. |
| 1995 | Private Securities Litigation Reform Act of 1995. |
| 1996 | Health Insurance Portability and Accountability Act of 1996 (HIPAA). |
| 2000 | Kesselman & Kesselman began serving as the company's auditor. |
| 2003-10-28 | Original lease agreement between Protalix Ltd. and Angel Science Park (99) Ltd. |
| 2004 | Protalix Ltd. has an Approved Enterprise plan since 2004. |
| 2005-04 | Protalix Ltd. entered into a license agreement with Icon Genetics AG. |
| 2005-04-18 | Amendment to Lease Agreement between Protalix Ltd. and Angel Science Park (99) Ltd. |
| 2005-04 | Amendment No. 60 to the Encouragement of Capital Investments Law. |
| 2006-12-14 | Board of Directors adopted the Protalix BioTherapeutics, Inc. 2006 Stock Incentive Plan. |
| 2007-09 | Food and Drug Administration Amendments Act of 2007. |
| 2009 | Protalix Ltd. has a Benefited Enterprise plan since 2009. |
| 2009-11-30 | Pfizer Agreement between Protalix Ltd. and Pfizer Inc. |
| 2010-08 | Vpriv (Takeda Shire) granted ten-year market exclusivity. |
| 2010-12-29 | Amendment 68 to the Encouragement of Capital Investments Law. |
| 2012-05 | Elelyso approved by the FDA. |
| 2012-06 | CHMP issued a positive opinion regarding the benefit of Elelyso. |
| 2013-06-18 | Brazil Agreement between Protalix Ltd. and Fundao Oswaldo Cruz. |
| 2014-01 | Brazil Agreement with Fiocruz became effective. |
| 2014-08 | FDA approved Elelyso for pediatric patients. |
| 2015-10 | Amended Pfizer Agreement between Pfizer Inc. and Protalix Ltd. |
| 2016-03 | Protalix BioTherapeutics, Inc. reincorporated in Delaware. |
| 2016 | EC withdrew marketing authorization for Krystexxa. |
| 2016-12-29 | Amendment 73 to the Encouragement of Capital Investments Law. |
| 2017-10-17 | Chiesi Ex-US Agreement between Protalix Ltd. and Chiesi Farmaceutici S.p.A. |
| 2017-12-22 | U.S. Tax Cuts and Jobs Act (TCJA) enacted. |
| 2018-07-23 | Chiesi US Agreement between Protalix Ltd. and Chiesi Farmaceutici S.p.A. |
| 2020-05 | Initial BLA for Elfabrio submitted to the FDA. |
| 2020-05 | Initiated our phase I clinical trial of PRX-115 for the potential treatment of uncontrolled gout. |
| 2021-04 | FDA issued a CRL in response to the initial BLA for Elfabrio. |
| 2021-05-13 | Binding term sheet signed with Chiesi amending the Chiesi Agreements. |
| 2021-06 | Received $10.0 million payment from Chiesi. |
| 2021-07-02 | Entered into an At The Market Offering Agreement with H.C. Wainwright & Co., LLC. |
| 2022-02 | PRX-102 MAA submitted to the EMA. |
| 2022-05-02 | Amended the At The Market Offering Agreement with H.C. Wainwright & Co., LLC. |
| 2022-08 | Vpriv (Takeda Shire) market exclusivity expired. |
| 2022-08-29 | Entered into the F/F Agreement and the Letter Agreement with Chiesi. |
| 2022-11-09 | Resubmitted to the FDA a BLA for PRX-102. |
| 2023-02 | CHMP adopted a positive opinion, recommending marketing authorization for PRX-102. |
| 2023-02-27 | Entered into an At The Market Offering Agreement with H.C. Wainwright & Co., LLC. |
| 2023-03 | Initiated phase I clinical trial of PRX-115. |
| 2023-05 | Elfabrio approved by the EC for marketing in the EU and in the United States. |
| 2023-09 | Engaged one of its non-executive directors to advise the Company regarding business development and licensing efforts on a consultancy basis. |
| 2023-10 | Hamas terrorists infiltrated Israels southern border from the Gaza Strip. |
| 2024-06-27 | Held Annual Meeting of Stockholders. |
| 2024-09 | Repaid in full all outstanding principal and interest payable under the 2024 Notes. |
| 2024-11 | Amended the Fill/Finish Agreement with Chiesi. |
| 2024-12-09 | EMA validated Chiesis Variation Submission for pegunigalsidase alfa. |
| 2024-12 | Board of Directors unanimously approved and adopted an amendment and restatement of our company Bylaws. |
| 2025-01 | Ceasefire with Hamas was declared. |
| 2025-03-11 | Warrants expired. |
| 2025 | Phase II clinical trial of PRX-115 expected to commence in the second half of 2025. |
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