Protalix BioTherapeutics Reports Fiscal Year 2023 Financial and Business Results
- Protalix achieved marketing authorizations for Elfabrio in various regions for Fabry disease treatment.
- The Company recorded a significant increase in revenues from selling goods and license and R&D services in 2023 compared to 2022.
- PRX-115, a potential treatment for severe gout, is undergoing a phase I clinical trial with preliminary results expected in the second quarter of 2024.
- Eliot Richard Forster, Ph.D., assumed the role of Chairman of the Board of Directors in September 2023.
- Net income for the year ended December 31, 2023, was approximately $8.3 million, a notable improvement compared to a net loss in 2022.
- None.
Insights
The reported financial results of Protalix BioTherapeutics, Inc. for the fiscal year ending December 31, 2023, reveal a substantial 60% increase in revenues from selling goods, primarily driven by the sales of Elfabrio post-FDA and EMA approvals. This performance is a strong indicator of the company's growing market presence and successful commercialization efforts, particularly in the rare disease segment. The $20.0 million milestone payment from Chiesi, triggered by FDA approval, is a significant liquidity event that strengthens the company's financial position. However, investors should consider the 28% increase in selling, general and administrative expenses, which reflects the cost of expanding operations and possibly the commercialization efforts for Elfabrio.
Another critical financial aspect is the 42% decrease in research and development expenses, which could signal the completion of costly clinical phases for certain products, thus potentially reducing future R&D expenditure. However, it is essential to monitor ongoing and future R&D investments, such as the PRX-115 trials, as they are indicative of the company's pipeline vitality and long-term growth prospects. The net income of approximately $8.3 million is a positive shift from the previous year's net loss of $14.9 million, reflecting a favorable trend in the company's profitability. This turnaround is an important consideration for investors, as it may influence the company's valuation and stock performance.
Protalix BioTherapeutics' progress with Elfabrio represents a significant milestone in the treatment of Fabry disease, a rare genetic disorder. The successful authorization of Elfabrio in multiple key markets, including the United States, the European Union and the UK, indicates the company's ability to navigate the complex regulatory landscape and serves as a testament to the potential of its ProCellEx® protein expression system. The market for rare diseases is characterized by high barriers to entry and significant pricing power, which can lead to substantial revenue opportunities for successful entrants like Protalix.
Looking at the clinical development of PRX-115 for severe gout, the initiation of a first-in-human phase I clinical trial is a critical step in the company's pipeline development. Given that severe gout is a condition with unmet medical needs and limited treatment options, the successful development of PRX-115 could open up a new and lucrative market segment for Protalix. The anticipation of trial results in the second quarter of 2024 suggests a potential catalyst for the company's stock in the near term. Stakeholders should monitor these developments closely as they could have a significant impact on the company's future revenue streams and competitive positioning within the biotechnology sector.
The approval and commercialization of Elfabrio, a PEGylated recombinant human α-Galactosidase-A enzyme, for Fabry disease, underscores Protalix's innovation in enzyme replacement therapies (ERTs). The use of PEGylation technology in ERTs is designed to enhance the stability and half-life of therapeutic enzymes, potentially improving treatment outcomes and patient adherence. The clinical and commercial advancements of Elfabrio could provide a more effective treatment option for patients, potentially improving their quality of life and reducing disease burden.
Furthermore, the development of PRX-115, a recombinant PEGylated uricase, addresses severe gout, a condition that can lead to debilitating pain and joint damage. The ongoing phase I clinical trial is a crucial step in assessing the safety and efficacy of this novel therapeutic approach. The successful development of PRX-115 could represent a significant advancement in the treatment of severe gout, offering a new therapeutic option for patients who are unresponsive to conventional treatments. The progression of PRX-115 through clinical trials will be an important area to watch, as it may influence the company's strategic focus and resource allocation.
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL,
"2023 was a significant year for Protalix, as we received regulatory approvals of Elfabrio for the treatment of adult patients with Fabry disease and advanced our growing pipeline," said Dror Bashan, Protalix's President and Chief Executive Officer. "As the second drug produced through our proven protein expression platform, Elfabrio's approval is a welcome milestone for Fabry disease patients and their families. Our commercial partner Chiesi Global Rare Diseases is continuing to position Elfabrio for global success, with launches underway in
Fiscal Year 2023 and Recent Business Highlights
Regulatory and Commercial Advancements
The Company, together with its development and commercialization partner, Chiesi Global Rare Diseases (Chiesi), a business unit of the Chiesi Group, gained marketing authorizations in
- On May 5, 2023, the Company announced that the European Commission (EC) granted marketing authorization to Elfabrio in the European Union for the treatment of adult patients with Fabry disease.
- On May 10, 2023, the Company announced that the U.S. Food and Drug Administration (FDA) approved Elfabrio in
the United States for the treatment of adult patients with Fabry disease. - On August 15, 2023, Chiesi announced that the
UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Elfabrio inGreat Britain for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease. - On September 11, 2023, Swissmedic, the national authorization and supervisory authority for drugs and medical products in
Switzerland , announced the approval of Elfabrio inSwitzerland for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease. - In January 2024, the Israeli Ministry of Health granted principle approval of Elfabrio for adult patients with a confirmed diagnosis of Fabry disease.
The FDA approval triggered a
Clinical Developments
In March 2023, the first patient was dosed in the Company's First in Human (FIH) Phase I clinical trial of PRX–115, a recombinant PEGylated uricase product candidate under development as a potential treatment for severe gout. The FIH trial is a double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of PRX–115 in approximately 56 patients with elevated uric acid levels (>6.0 mg/dL) and no previous exposure to PEGylated uricase. The study, which is fully-enrolled, is being conducted at the New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines. The Company anticipates that preliminary results from the study will be published in the second quarter of 2024.
Corporate Developments
On September 14, 2023, Eliot Richard Forster, Ph.D. began his tenure as Chairman of the Board of Directors, replacing former Chairman Zeev Bronfeld, who retired for personal reasons.
Fiscal Year 2023 Financial Highlights
- The Company recorded revenues from selling goods of
$40.4 million $15.1 million 60% , compared to revenues of$25.3 million $14.1 million $0 $0 Brazil , resulting from timing differences. - The Company recorded revenues from license and R&D services of
$25.1 million $2.8 million 13% , compared to revenues of$22.3 million $20.0 million $17 - Cost of goods sold was
$23.0 million $3.4 million 17% , compared to cost of goods sold of$19.6 million Brazil and to Pfizer. Sales to Chiesi included certain drug substance costs which had already been recognized as research and development expenses as it was produced as part of research and development activities. Accordingly, the related cost of goods sold does not include the costs of such drug substance. - For the year ended December 31, 2023, the Company's total research and development expenses were approximately
$17.1 million $6.3 million $7.8 million $0.6 million $2.4 million $29.3 million $17.8 million $7.3 million $1.4 million $2.8 million $12.2 million 42% , for the year ended December 31, 2023 compared to the year ended December 31, 2022. The decrease in research and development expenses resulted primarily from a$11.5 million $0.8 million - Selling, general and administrative expenses were
$15.0 million $3.3 million 28% , from$11.7 million $2.3 million $0.3 million - Financial expense, net was
$1.9 million $0.5 million 36% , compared to financial expenses of$1.4 million $0.9 million $0.7 million $0.4 million $0.6 million - For the year ended December 31, 2023, the Company recorded income taxes of approximately
$0.3 million $0.2 million 40% , compared to tax expenses of$0.5 million U.S. taxable global intangible low-taxed income (GILTI) mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act (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. The net income taxes gives effect to a valuation allowance release equal to approximately$3 - Cash, cash equivalents and short-term bank deposits were approximately
$44.6 million - Net income for the year ended December 31, 2023 was approximately
$8.3 million $0.12 $0.09 $14.9 million $0.31
Conference Call and Webcast Information
The Company will host a conference call today, March 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: Thursday, March 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: 13744193
Call me™: https://tinyurl.com/4pkhcxcj
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 Company's website and will be available via the following links:
Company Link: https://protalixbiotherapeutics.gcs-web.com/events0
Webcast Link: https://tinyurl.com/mumnf9da
Conference ID: 13744193
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
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 severe 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
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Investor Contact
Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
PROTALIX BIOTHERAPEUTICS, INC. | ||||||
December 31, | ||||||
2022 | 2023 | |||||
ASSETS | ||||||
CURRENT ASSETS: | ||||||
Cash and cash equivalents | $ | 17,111 | $ | 23,634 | ||
Short-term bank deposits | 5,069 | 20,926 | ||||
Accounts receivable – Trade | 4,586 | 5,272 | ||||
Other assets | 1,310 | 1,055 | ||||
Inventories | 16,804 | 19,045 | ||||
Total current assets | $ | 44,880 | $ | 69,932 | ||
NON-CURRENT ASSETS: | ||||||
Funds in respect of employee rights upon retirement | $ | 1,267 | $ | 528 | ||
Property and equipment, net | 4,553 | 4,973 | ||||
Deferred income tax asset | — | 3,092 | ||||
Operating lease right of use assets | 5,087 | 5,909 | ||||
Total assets | $ | 55,787 | $ | 84,434 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY (NET OF CAPITAL DEFICIENCY) | ||||||
CURRENT LIABILITIES: | ||||||
Accounts payable and accruals: | ||||||
Trade | $ | 5,862 | $ | 4,320 | ||
Other | 12,271 | 19,550 | ||||
Operating lease liabilities | 1,118 | 1,409 | ||||
Contracts liability | 13,178 | — | ||||
Convertible notes | — | 20,251 | ||||
Total current liabilities | $ | 32,429 | $ | 45,530 | ||
LONG TERM LIABILITIES: | ||||||
Convertible notes | $ | 28,187 | ||||
Liability for employee rights upon retirement | 1,642 | $ | 714 | |||
Operating lease liabilities | 4,169 | 4,621 | ||||
Total long term liabilities | $ | 33,998 | $ | 5,335 | ||
Total liabilities | $ | 66,427 | $ | 50,865 | ||
COMMITMENTS | ||||||
STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) | ||||||
Common Stock, | 54 | 73 | ||||
Additional paid-in capital | 379,167 | 415,045 | ||||
Accumulated deficit | (389,861) | (381,549) | ||||
Total stockholders' equity (capital deficiency) | (10,640) | 33,569 | ||||
Total liabilities and stockholders' equity (net of capital deficiency) | $ | 55,787 | $ | 84,434 | ||
PROTALIX BIOTHERAPEUTICS, INC. | |||||||||
Year Ended December 31, | |||||||||
2021 | 2022 | 2023 | |||||||
REVENUES FROM SELLING GOODS | $ | 16,749 | $ | 25,292 | $ | 40,418 | |||
REVENUES FROM LICENSE AND R&D SERVICES | 21,601 | 22,346 | 25,076 | ||||||
TOTAL REVENUE | 38,350 | 47,638 | 65,494 | ||||||
COST OF GOODS SOLD | (16,349) | (19,592) | (22,982) | ||||||
RESEARCH AND DEVELOPMENT EXPENSES | (29,734) | (29,349) | (17,093) | ||||||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (12,729) | (11,711) | (14,959) | ||||||
OPERATING INCOME (LOSS) | (20,462) | (13,014) | 10,460 | ||||||
FINANCIAL EXPENSES | (7,521) | (2,529) | (3,180) | ||||||
FINANCIAL INCOME | 401 | 1,146 | 1,286 | ||||||
FINANCIAL EXPENSES, NET | (7,120) | (1,383) | (1,894) | ||||||
INCOME (LOSS) BEFORE TAXES ON INCOME | (27,582) | (14,397) | 8,566 | ||||||
TAXES ON INCOME | — | (530) | (254) | ||||||
NET INCOME (LOSS) FOR THE PERIOD | $ | (27,582) | $ | (14,927) | $ | 8,312 | |||
EARNINGS (LOSS) PER SHARE OF COMMON STOCK: | |||||||||
BASIC | $ | (0.62) | $ | (0.31) | $ | 0.12 | |||
DILUTED | $ | (0.62) | $ | (0.31) | $ | 0.09 | |||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK | |||||||||
USED IN COMPUTING EARNINGS (LOSS) PER SHARE: | |||||||||
BASIC | 44,140,233 | 48,472,159 | 67,512,527 | ||||||
DILUTED | 44,140,233 | 48,472,159 | 82,424,016 | ||||||
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SOURCE Protalix BioTherapeutics, Inc.
FAQ
What regulatory approvals did Protalix BioTherapeutics, Inc. receive in 2023?
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