Full Press Release Details
Protalix BioTherapeutics Reports Second Quarter 2023 Financial and Business Results
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL, Israel, August 7, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, today reported financial results for the second quarter ended June 30, 2023 and provided a business update on recent regulatory, clinical and corporate developments.
"2023 has been a transformational year for Protalix thus far," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are very proud to have received regulatory approval for Elfabrio in both the United States and the European Union, a significant milestone for adult Fabry disease patients and their families alike. Our commercial partner, Chiesi Global Rare Diseases, has the expertise and global reach to maximize the potential of Elfabrio, and Chiesi has already launched the product in the United States. As the second approved drug from our proprietary platform, this approval not only validates our recombinant protein expression platform but also our strong clinical and regulatory expertise in rare diseases. We now turn our focus to strengthening our rare disease pipeline programs and building a sustainable portfolio. We extend our gratitude to our team and dedicated partners for their commitment to our programs and more importantly to patients in need."
2023 Second Quarter and Recent Business Highlights
Regulatory Advancements
The Company, together with its development and commercialization partner, Chiesi Global Rare Diseases (Chiesi), a business unit of the Chiesi Group, announced that Elfabrio (pegunigalsidase alfa) received regulatory approval in both the United States (U.S.) and European Union (EU) for the treatment of adult patients with Fabry disease in the 1 mg\kg every two weeks dosage. Elfabrio, a PEGylated enzyme replacement therapy (ERT), is a recombinant human -Galactosidase-A enzyme expressed in plant-cell culture that is designed to provide a long half-life.
Clinical Developments
Corporate Developments
Second Quarter 2023 Financial Highlights
Conference Call and Webcast Information
The Company will host a conference call today, August 7, 2023 at 8:30 am EDT, to review the regulatory, clinical and corporate developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date:Monday, August 7, 2023
Toll Free:1-877-423-9813
International:1-201-689-8573
Conference ID:13740122
The Call me feature, which avoids having to wait for an operator, may be accessed at the following link: https://tinyurl.com/2v682k5m.
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/348f738e
Conference ID:13740122
Participants are requested to access the websites at least 15 minutes ahead of the conference call 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 a 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 Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio , was approved by both the FDA and the European Medicines Agency in May 2023. 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, 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; risks related to our commercialization partner's ability to obtain and maintain reimbursement for Elfabrio, and the extent to which patient assistance programs and co-pay programs are utilized; the likelihood that the FDA, EMA or other applicable health regulatory authorities will approve an alternative dosing regimen for Elfabrio; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; 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; risks associated with the novel coronavirus disease, or COVID-19, outbreak and variants, which may adversely impact our business, preclinical studies and clinical trials; risks associated with global conditions and developments such as supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks relating to our evaluation and pursuit of strategic partnerships; the risk that the results of our clinical trials will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer and Chiesi; risks related to the amount and sufficiency of our
cash and cash equivalents; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; risks relating to the compliance by Fiocruz with its purchase obligations under our supply and technology transfer agreement, which may have a material adverse effect on us and may also result in the termination of such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; the possible disruption of our operations due to terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Chuck Padala, Managing Director
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| June 30, 2023 | December 31, 2022 | |||||
| ASSETS | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $ | 48,184 | $ | 17,111 | ||
| Short-term bank deposits | - | 5,069 | ||||
| Accounts receivable - Trade | 4,049 | 4,586 | ||||
| Other assets | 1,708 | 1,310 | ||||
| Inventories | 19,635 | 16,804 | ||||
| Total current assets | $ | 73,576 | $ | 44,880 | ||
| NON-CURRENT ASSETS: | ||||||
| Funds in respect of employee rights upon retirement | $ | 1,268 | $ | 1,267 | ||
| Property and equipment, net | 4,637 | 4,553 | ||||
| Deferred income tax asset | 3,130 | - | ||||
| Operating lease right of use assets | 5,806 | 5,087 | ||||
| Total assets | $ | 88,417 | $ | 55,787 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY (NET OF CAPITAL DEFICIENCY) | ||||||
| CURRENT LIABILITIES: | ||||||
| Accounts payable and accruals: | ||||||
| Trade | $ | 3,304 | $ | 5,862 | ||
| Other | 18,545 | 12,271 | ||||
| Operating lease liabilities | 1,260 | 1,118 | ||||
| Contracts liability | - | 13,178 | ||||
| Total current liabilities | $ | 23,109 | $ | 32,429 | ||
| LONG TERM LIABILITIES: | ||||||
| Convertible notes | $ | 20,132 | $ | 28,187 | ||
| Liability for employee rights upon retirement | 1,598 | 1,642 | ||||
| Operating lease liabilities | 4,577 | 4,169 | ||||
| Total long term liabilities | $ | 26,307 | $ | 33,998 | ||
| Total liabilities | $ | 49,416 | $ | 66,427 | ||
| COMMITMENTS | ||||||
| STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) | 39,001 | (10,640) | ||||
| Total liabilities and stockholders' equity (net of capital deficiency) | $ | 88,417 | $ | 55,787 |
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
| Six Months Ended | Three Months Ended | |||||||||||||
| June 30, 2023 | June 30, 2022 | June 30, 2023 | June 30, 2022 | |||||||||||
| REVENUES FROM SELLING GOODS | $ | 20,141 | $ | 12,410 | $ | 15,075 | $ | 3,382 | ||||||
| REVENUES FROM LICENSE AND R&D SERVICES | 24,522 | 12,428 | 20,000 | 5,371 | ||||||||||
| TOTAL REVENUE | 44,663 | 24,838 | 35,075 | 8,753 | ||||||||||
| COST OF GOODS SOLD (1) | (9,233) | (10,121) | (6,148) | (4,087) | ||||||||||
| RESEARCH AND DEVELOPMENT EXPENSES (2) | (10,322) | (16,346) | (4,475) | (7,579) | ||||||||||
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (3) | (7,146) | (5,765) | (4,031) | (2,611) | ||||||||||
| OPERATING INCOME (LOSS) | 17,962 | (7,394) | 20,421 | (5,524) | ||||||||||
| FINANCIAL EXPENSES | (2,169) | (1,242) | (1,305) | (623) | ||||||||||
| FINANCIAL INCOME | 918 | 1,016 | 531 | 813 | ||||||||||
| FINANCIAL INCOME (EXPENSES), NET | (1,251) | (226) | (774) | 190 | ||||||||||
| INCOME (LOSS) BEFORE TAXES ON INCOME | 16,711 | (7,620) | 19,647 | (5,334) | ||||||||||
| TAXES ON INCOME | (503) | - | (308) | - | ||||||||||
| NET INCOME (LOSS) FOR THE PERIOD | $ | 16,208 | $ | (7,620) | $ | 19,339 | $ | (5,334) | ||||||
| EARNINGS (LOSS) PER SHARE OF COMMON STOCK: | ||||||||||||||
| BASIC | $ | 0.26 | $ | (0.16) | $ | 0.29 | $ | (0.11) | ||||||
| DILUTED | $ | 0.18 | $ | (0.16) | $ | 0.21 | $ | (0.11) | ||||||
| WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK | ||||||||||||||
| USED IN COMPUTING EARNINGS (LOSS) PER SHARE: | ||||||||||||||
| BASIC | 62,378,745 | 46,589,976 | 67,158,628 | 47,327,952 | ||||||||||
| DILUTED | 78,896,220 | 46,589,976 | 83,200,641 | 47,327,952 | ||||||||||
| (1) Includes share-based compensation | $ | 104 | $ | 22 | $ | 46 | $ | 28 | ||||||
| (2) Includes share-based compensation | $ | 324 | $ | 161 | $ | 144 | $ | 85 | ||||||
| (3) Includes share-based compensation | $ | 556 | $ | 941 | $ | 248 | $ | 175 |