Protalix BioTherapeutics, Inc. (NYSE:PLX) Q4 2023 Earnings Conference Call March 14, 2024 8:30 AM ET Company Participants Lauren Merrick - Investor Relations Dror Bashan - President and Chief Executive Officer Eyal Rubin - Senior Vice President and Chief Financial Officer Conference Call Participants John Vandermosten - Zacks Operator Good morning, ladies and gentlemen and welcome to the Protalix BioTherapeutics Fiscal Year 2023 Financial and Business Results Conference Call. As a reminder, this conference ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 001-33357 (Commission file number) P ...

Exhibit 99.1 Protalix BioTherapeutics Reports Fiscal Year 2023 Financial and Business Results Company to host conference call and webcast today at 8:30 a.m. EDT CARMIEL, Israel, March 14, 2024 /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 f ...

Financial Data and Key Metrics Changes - Cost of goods sold decreased by $2.2 million, or 31%, to $4.9 million for Q3 2023 compared to $7.1 million for Q3 2022, primarily due to decreased sales to Pfizer, partially offset by increased sales of Elfabrio to Chiesi and Elelyso to Brazil [8] - Net loss for Q3 2023 was approximately $1.9 million, or $0.03 per share, compared to a net loss of $3.6 million, or $0.07 per share, for the same period in 2022 [10] - Revenues from selling goods increased by $1.4 million, or 16%, to $10.2 million in Q3 2023 compared to $8.8 million in Q3 2022, driven by increased sales to Chiesi and Brazil, offset by decreased sales to Pfizer [31] - Total research and development expenses decreased by $3.7 million, or 50%, to approximately $3.7 million in Q3 2023 compared to $7.4 million in Q3 2022, primarily due to the completion of the Fabry clinical program [32] Business Line Data and Key Metrics Changes - Revenues from license and R&D services decreased by $5.2 million, or 96%, to $0.2 million in Q3 2023 compared to $5.4 million in Q3 2022, due to the transfer of sponsorship of extension studies to Chiesi [18] - Selling, general and administrative expenses increased by $0.9 million, or 32%, to $3.7 million in Q3 2023 compared to $2.8 million in Q3 2022, primarily due to increased salary and related expenses [19] Market Data and Key Metrics Changes - The company has received regulatory approvals for Elfabrio in the UK and Switzerland, with plans to expand into other markets, including Japan [38] - The company is focusing on building market presence and inventory with Chiesi, which is expected to fluctuate over the next couple of years [37] Company Strategy and Development Direction - The company is committed to developing its pipeline assets to address high unmet medical needs, following the approval of Elfabrio and Elelyso [15] - The company aims to maintain a strong balance sheet to support strategic plans without the need for near-term capital infusion [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to operate without disruptions despite challenging circumstances in Israel [14] - The company does not provide specific revenue guidance for Q4 2023 due to the dynamic nature of orders from Chiesi and Pfizer [42] Other Important Information - The company announced the appointment of Dr. Eliot Forster as Chairman of the Board, succeeding Mr. Zeev Bronfeld [30] - Cash, cash equivalents, and short-term bank deposits were approximately $41 million as of September 30, 2023 [20] Q&A Session Summary Question: What are the underlying factors for the drop in revenue from $15 million in Q2 to $10 million in Q3? - Management indicated that the decrease was due to reduced sales to Pfizer and inventory buildup by Chiesi, which may lead to fluctuations in sales as they penetrate the market [12][37] Question: Can you discuss the Fabry disease market opportunity in the UK and Switzerland? - Management noted that the drug has been approved in most Western countries, including the UK and Switzerland, and they are looking to expand into other markets like Japan [38] Question: What are the next steps for the PRX-115 program? - The company plans to gather data from the ongoing Phase 1 study and will decide on further steps based on safety and efficacy results [60] Question: How does the company view its capital structure with two revenue-generating products? - Management stated that the company is self-sustained and does not foresee the need for additional capital in the near future, expecting gradual changes in capital structure as revenues ramp up [52] Question: What are the expectations for the topline results from the PRX-115 study? - Management indicated that topline results are expected in mid-2024, and they will assess the data to determine the next steps for the program [16][54]

PART I – FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the period ended September 30, 2023, encompassing balance sheets, statements of operations, changes in equity, and cash flows [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets significantly increased by September 30, 2023, while total liabilities decreased, leading to a shift from a capital deficiency to positive stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Current Assets** | $72,618 | $44,880 | | Cash and cash equivalents | $20,408 | $17,111 | | Inventories | $21,583 | $16,804 | | **Total Assets** | **$87,569** | **$55,787** | | **Total Current Liabilities** | $43,359 | $32,429 | | **Total Liabilities** | **$49,322** | **$66,427** | | **Total Stockholders' Equity (Deficiency)** | **$38,247** | **($10,640)** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company achieved a net income of **$14,356 thousand** for the nine months ended September 30, 2023, a significant turnaround from a prior-year loss, driven by increased revenues and reduced R&D expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $55,008 | $39,021 | $10,345 | $14,183 | | **Operating Income (Loss)** | $16,075 | ($10,519) | ($1,887) | ($3,125) | | **Net Income (Loss)** | **$14,356** | **($11,187)** | **($1,852)** | **($3,567)** | | **Diluted EPS** | **$0.16** | **($0.24)** | **($0.04)** | **($0.07)** | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased to **$4,913 thousand** for the nine months ended September 30, 2023, reflecting improved profitability and a net increase in cash from financing activities Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,913) | ($22,389) | | Net cash used in investing activities | ($16,369) | ($9,988) | | Net cash provided by financing activities | $24,666 | $4,163 | | **Net Increase (Decrease) in Cash** | **$3,297** | **($28,265)** | | **Cash at End of Period** | **$20,408** | **$10,720** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies, business developments including Elfabrio's approvals and a **$20,000 thousand** milestone payment, product pipeline updates, and potential impacts from the Israel conflict - Elfabrio® (pegunigalsidase alfa) received marketing approval from the European Commission (EC) on **May 5, 2023**, and the U.S. Food and Drug Administration (FDA) on **May 9, 2023**, for the treatment of adult patients with Fabry disease[26](index=26&type=chunk) - Following the FDA approval of Elfabrio, the company received a **$20,000 thousand** milestone payment from its commercial partner, Chiesi[41](index=41&type=chunk)[58](index=58&type=chunk) - The company's product pipeline includes PRX-115 for severe gout, which entered a **Phase I** clinical trial in **March 2023**, and PRX-119 for NETs-related diseases[34](index=34&type=chunk)[35](index=35&type=chunk) Disaggregation of Revenues (in thousands) | Revenue Source | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | **Revenues from selling goods** | | | | Pfizer | $7,972 | $11,279 | | Brazil | $5,120 | $7,162 | | Chiesi | $17,217 | $2,781 | | **Total revenues from selling goods** | **$30,309** | **$21,222** | | **Revenues from license and R&D services** | **$24,699** | **$17,799** | - In **October 2023**, the company noted that the war declared by Israel against Hamas could potentially affect its business and operations, although no direct impact has occurred to date[93](index=93&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes financial results, highlighting the impact of Elfabrio's approvals on revenue, reduced R&D expenses, improved liquidity with **$41,000 thousand** cash, and product pipeline progress [Recent Company Developments & Pipeline](index=19&type=section&id=Recent%20Company%20Developments%20%26%20Pipeline) The company highlights recent regulatory approvals and commercialization of Elfabrio across key markets, details its ProCellEx® platform, and provides an overview of its product pipeline, including clinical-stage candidates - Elfabrio received marketing authorization in Great Britain (**August 2023**) and Switzerland (**September 2023**) for adult patients with Fabry disease[97](index=97&type=chunk)[99](index=99&type=chunk) Product Pipeline Status | Product | Indication | Development Stage | | :--- | :--- | :--- | | **Elelyso®** | Gaucher Disease | Approved in 23 markets | | **Elfabrio®** | Fabry Disease | Approved (US and EU) | | **Uricase (PRX-115)** | Severe Gout | Phase I (Final results expected Q2'24) | | **Long Acting (LA) DNase I (PRX-119)** | NETs-Related Diseases | Discovery and Preclinical | - The **Phase III BALANCE study** results suggested comparability in treatment effects between PRX-102 and agalsidase beta, with a potentially favorable safety profile for PRX-102 based on lower rates of infusion-related reactions and anti-drug antibodies[144](index=144&type=chunk)[145](index=145&type=chunk) - The first patient was dosed in the **Phase I** trial for PRX-115 for severe gout in **March 2023**; as of **September 30, 2023**, **32 patients** have been dosed[181](index=181&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Financial performance significantly improved, with revenues from goods rising **43%** and license/R&D services increasing **39%** for the nine months ended September 30, 2023, while R&D expenses decreased **41%** Financial Performance vs. Prior Year (Nine Months Ended Sep 30) | Metric (in millions) | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Revenues from Selling Goods | $30.3 | $21.2 | +43% | | Revenues from License and R&D Services | $24.7 | $17.8 | +39% | | Cost of Goods Sold | $14.1 | $17.2 | -18% | | Research and Development Expenses | $14.0 | $23.7 | -41% | Financial Performance vs. Prior Year (Three Months Ended Sep 30) | Metric (in millions) | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Revenues from Selling Goods | $10.2 | $8.8 | +16% | | Revenues from License and R&D Services | $0.2 | $5.4 | -96% | | Research and Development Expenses | $3.7 | $7.4 | -50% | [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company held **$41,000 thousand** in cash and equivalents, deemed sufficient for the next 12 months, with reduced convertible notes and improved operating cash flow - The company had **$41,000 thousand** in cash, cash equivalents, and short-term bank deposits as of **September 30, 2023**[215](index=215&type=chunk) - Management believes current cash is sufficient to satisfy capital needs for at least **12 months** from the report's issuance date[219](index=219&type=chunk)[227](index=227&type=chunk) - Net cash used in operating activities for the nine months ended **September 30, 2023**, was **$4,913 thousand**, compared to **$22,389 thousand** for the same period in **2022**[220](index=220&type=chunk)[223](index=223&type=chunk) - As of **September 30, 2023**, the total principal amount of the 2024 Notes outstanding was **$20,420 thousand**, following conversions that reduced the principal by approximately **$8,300 thousand** during the nine-month period[217](index=217&type=chunk)[226](index=226&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is currency exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel, impacting operating results due to significant NIS-denominated costs - The main market risk is currency exchange risk between the U.S. dollar (functional currency) and the New Israeli Shekel (NIS)[233](index=233&type=chunk) - Approximately **43%** of the company's costs, including salaries and office expenses, are incurred in NIS[234](index=234&type=chunk) - The company estimates that a **1%** revaluation of the NIS would affect its loss before tax by less than **1%**[234](index=234&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of **September 30, 2023**[236](index=236&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended **September 30, 2023**, that have materially affected, or are reasonably likely to materially affect, internal controls[239](index=239&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently involved in any material legal proceedings - The company is not involved in any material legal proceedings[240](index=240&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors, primarily focusing on geopolitical risks in Israel, which could adversely affect operations, supply chains, and personnel due to ongoing military conflict - A key risk factor is the company's location in Israel, where political, economic, and military conditions, such as the war declared in **October 2023**, could adversely affect operations[242](index=242&type=chunk) - To date, operations have not been adversely affected by the conflict, but facilities are within range of potential rocket attacks, and government insurance may not cover all potential damages[242](index=242&type=chunk) - The obligation of many employees to perform military reserve duty, especially during a conflict, could disrupt operations and have a material adverse effect on the business[244](index=244&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds from such sales during the reporting period - None[245](index=245&type=chunk) [Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon its senior securities - None[246](index=246&type=chunk) [Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable[248](index=248&type=chunk) [Other Information](index=38&type=section&id=Item%205.%20Other%20Information) The company states that none of its directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the third quarter of 2023 - During the quarter ended **September 30, 2023**, no directors or officers adopted or terminated a Rule 10b5-1 trading arrangement[249](index=249&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - The exhibits list includes CEO and CFO certifications (**Exhibits 31.1, 31.2, 32.1, 32.2**) and Inline XBRL files (**Exhibit 101 series**) filed with the report[250](index=250&type=chunk)[252](index=252&type=chunk)

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q2 2023 Earnings Conference Call August 7, 2023 8:30 AM ET Company Participants Charles Padala - IR Dror Bashan - President and CEO Eyal Rubin - SVP and CFO Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright John Vandermosten - Zacks Unidentified Analyst - Private Investor Operator Good morning, ladies and gentlemen and welcome to the Protalix BioTherapeutics Conference for Second Quarter 2023 Financial Business Results. As a reminder, this confere ...

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This part presents the company's unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes providing context on accounting policies, revenue recognition, stock transactions, and tax implications for the periods ended June 30, 2023, and December 31, 2022 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)%20%E2%80%93%20As%20of%20June%2030,%202023%20and%20December%2031,%202022) | ASSETS (U.S. dollars in thousands) | June 30, 2023 | December 31, 2022 | | :--------------------------------- | :------------ | :------------------ | | 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** | | 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)** | | | | 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** | | 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** | | **STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY)** | **$39,001** | **$(10,640)** | | **Total liabilities and stockholders' equity (net of capital deficiency)** | **$88,417** | **$55,787** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(Unaudited)%20%E2%80%93%20For%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202023%20and%202022) | (U.S. dollars in thousands, except share and per share data) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--------------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | REVENUES FROM SELLING GOODS | $15,075 | $3,382 | $20,141 | $12,410 | | REVENUES FROM LICENSE AND R&D SERVICES | $20,000 | $5,371 | $24,522 | $12,428 | | **TOTAL REVENUE** | **$35,075** | **$8,753** | **$44,663** | **$24,838** | | COST OF GOODS SOLD | $(6,148) | $(4,087) | $(9,233) | $(10,121) | | RESEARCH AND DEVELOPMENT EXPENSES | $(4,475) | $(7,579) | $(10,322) | $(16,346) | | SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | $(4,031) | $(2,611) | $(7,146) | $(5,765) | | **OPERATING INCOME (LOSS)** | **$20,421** | **$(5,524)** | **$17,962** | **$(7,394)** | | FINANCIAL EXPENSES | $(1,305) | $(623) | $(2,169) | $(1,242) | | FINANCIAL INCOME | $531 | $813 | $918 | $1,016 | | FINANCIAL INCOME (EXPENSES), NET | $(774) | $190 | $(1,251) | $(226) | | INCOME (LOSS) BEFORE TAXES ON INCOME | $19,647 | $(5,334) | $16,711 | $(7,620) | | TAXES ON INCOME | $(308) | — | $(503) | — | | **NET INCOME (LOSS) FOR THE PERIOD** | **$19,339** | **$(5,334)** | **$16,208** | **$(7,620)** | | EARNINGS (LOSS) PER SHARE OF COMMON STOCK: | | | | | | BASIC | $0.29 | $(0.11) | $0.26 | $(0.16) | | DILUTED | $0.21 | $(0.11) | $0.18 | $(0.16) | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Capital Deficiency)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Capital%20Deficiency)%20(Unaudited)%20%E2%80%93%20For%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202023%20and%202022) | (U.S. dollars in thousands, except share data) | Balance at January 1, 2023 | Changes during the six-month period ended June 30, 2023 | | :--------------------------------------------- | :------------------------- | :------------------------------------------------------ | | Common Stock (Number of Shares) | 53,790,167 | 12,560,150 (Issuance under Sales Agreement) | | | | 4,691,623 (Convertible notes conversions) | | | | 538,822 (Exercise of warrants) | | Common Stock (Amount) | $54 | $13 (Issuance under Sales Agreement) | | | | $5 (Convertible notes conversions) | | | | * (Exercise of warrants) | | Additional Paid-In Capital | $379,167 | $23,941 (Issuance under Sales Agreement) | | | | $7,778 (Convertible notes conversions) | | | | $812 (Share-based compensation related to stock options)| | | | $172 (Share-based compensation related to restricted stock awards) | | | | $712 (Exercise of warrants) | | Accumulated Deficit | $(389,861) | $16,208 (Net income for the period) | | **Total** | **$(10,640)** | **$39,001** | - Total stockholders' equity shifted from a capital deficiency of **$(10,640) thousand** at January 1, 2023, to positive equity of **$39,001 thousand** at June 30, 2023, driven by common stock issuances, convertible note conversions, and net income[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)%20%E2%80%93%20For%20the%20Six%20Months%20ended%20June%2030,%202023%20and%202022) | (U.S. dollars in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------- | :----------------------------- | :----------------------------- | | **CASH FLOWS FROM OPERATING ACTIVITIES:** | | | | Net income (loss) | $16,208 | $(7,620) | | Net cash provided by (used in) operating activities | $1,975 | $(13,185) | | **CASH FLOWS FROM INVESTING ACTIVITIES:** | | | | Investment in bank deposits | — | $(16,000) | | Proceeds from sale of short-term deposits | $5,000 | — | | Purchase of property and equipment | $(452) | $(357) | | Net cash provided by (used in) investing activities | $4,510 | $(15,900) | | **CASH FLOWS FROM FINANCING ACTIVITIES:** | | | | Proceeds from issuance of common stock under the Sales Agreement, net | $23,954 | $2,641 | | Exercise of warrants | $712 | $2 | | Net cash provided by financing activities | $24,666 | $2,643 | | EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | $(78) | $(51) | | NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | $31,073 | $(26,493) | | BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | $17,111 | $38,985 | | **BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD** | **$48,184** | **$12,492** | - Net cash provided by operating activities significantly improved to **$1,975 thousand** for the six months ended June 30, 2023, compared to net cash used of **$(13,185) thousand** in the prior year period[18](index=18&type=chunk) - Net cash provided by financing activities increased substantially to **$24,666 thousand** for the six months ended June 30, 2023, primarily due to proceeds from common stock issuance under the Sales Agreement[18](index=18&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements, covering accounting policies, revenue, stock, and tax information [NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES](index=8&type=section&id=NOTE%201%20-%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the company's business, its proprietary ProCellEx® protein expression system, key product approvals (Elfabrio for Fabry disease, Elelyso for Gaucher disease), product pipeline, and revenue recognition policies, including agreements with Chiesi and Pfizer - Elfabrio® (pegunigalsidase alfa) received Marketing Authorization Application (MAA) approval from the European Commission (EC) on **May 5, 2023**, and Biologics License Application (BLA) approval from the U.S. Food and Drug Administration (FDA) on **May 9, 2023**, for adult patients with Fabry disease[23](index=23&type=chunk) - The company's proprietary **ProCellEx®** protein expression system is used to develop and commercialize recombinant therapeutic proteins, including **two FDA-approved proteins**: taliglucerase alfa (Elelyso®) for Gaucher disease and pegunigalsidase alfa (Elfabrio®) for Fabry disease[22](index=22&type=chunk)[89](index=89&type=chunk) - The product pipeline includes **PRX-115** for severe gout (**Phase I clinical trial** initiated **March 21, 2023**) and **PRX-119** for NETs-related diseases[31](index=31&type=chunk)[32](index=32&type=chunk) - Under the Chiesi Agreements, the company has received **$50.0 million** in upfront payments and **$45.0 million** in development cost reimbursements, with potential for approximately **$1.0 billion** in milestone payments and tiered royalties (**15-35% ex-US**, **15-40% US**). A **$20.0 million** milestone payment was received following FDA approval of Elfabrio[38](index=38&type=chunk)[155](index=155&type=chunk) [NOTE 2 - INVENTORIES](index=15&type=section&id=NOTE%202%20-%20INVENTORIES) This note provides a detailed breakdown of the company's inventory components, including raw materials, work in progress, and finished goods, as of June 30, 2023, and December 31, 2022 | (U.S. dollars in thousands) | June 30, 2023 | December 31, 2022 | | :-------------------------- | :------------ | :------------------ | | Raw materials | $4,352 | $3,508 | | Work in progress | $3,318 | $2,678 | | Finished goods | $11,965 | $10,618 | | **Total inventory** | **$19,635** | **$16,804** | [NOTE 3 – FAIR VALUE MEASUREMENT](index=15&type=section&id=NOTE%203%20%E2%80%93%20FAIR%20VALUE%20MEASUREMENT) This note explains the company's methodology for fair value measurement, categorizing inputs into a three-level hierarchy, and provides the estimated fair value of its outstanding 2024 Convertible Notes - As of June 30, 2023, the fair value of the **$20.4 million** aggregate principal amount of the company's outstanding 2024 Notes is approximately **$28.1 million**, estimated using a Level 3 binomial model[61](index=61&type=chunk) 2024 Notes Valuation Parameters (June 30, 2023) | Parameter | Value | | :-------------- | :------- | | Stock price | $2.00 | | Expected term | 1.18 | | Risk free rate | 5.14 % | | Volatility | 60.90 % | | Yield | 12.76 % | [NOTE 4 – REVENUES](index=16&type=section&id=NOTE%204%20%E2%80%93%20REVENUES) This note disaggregates the company's revenues by customer (Pfizer, Brazil, Chiesi) and type (selling goods, license and R&D services) for the three and six months ended June 30, 2023, and 2022, highlighting significant growth from Chiesi | Revenue Source (in thousands) | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :---------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Pfizer | $3,402 | $3,382 | $5,668 | $6,738 | | Brazil | $0 | $0 | $2,800 | $5,454 | | Chiesi | $11,673 | $0 | $11,673 | $218 | | **Total revenues from selling goods** | **$15,075** | **$3,382** | **$20,141** | **$12,410** | | **Revenues from license and R&D services** | **$20,000** | **$5,371** | **$24,522** | **$12,428** | [NOTE 5 – STOCK TRANSACTIONS](index=16&type=section&id=NOTE%205%20%E2%80%93%20STOCK%20TRANSACTIONS) This note details significant changes in the company's capital structure, including the increase in authorized common stock, shares issued through At-the-Market (ATM) offerings, warrant exercises, and conversions of 2024 Notes - Stockholders approved an amendment to increase the number of authorized common stock shares from **144,000,000** to **185,000,000** on **July 13, 2023**[63](index=63&type=chunk)[86](index=86&type=chunk) - During the six months ended June 30, 2023, the company sold **12,560,150** shares of Common Stock under its 2023 Sales Agreement, generating approximately **$24.9 million** in gross proceeds[64](index=64&type=chunk) - The company issued **538,822** shares of Common Stock from warrant exercises, generating **$0.7 million** in net proceeds from cash exercises[65](index=65&type=chunk)[66](index=66&type=chunk) - Conversions of 2024 Notes resulted in the issuance of **4,691,623** shares of Common Stock and a decrease of approximately **$8.3 million** in the principal amount of outstanding notes during the six months ended June 30, 2023[67](index=67&type=chunk) [NOTE 6 – EARNINGS (LOSS) PER SHARE](index=17&type=section&id=NOTE%206%20%E2%80%93%20EARNINGS%20(LOSS)%20PER%20SHARE) This note details the calculation of basic and diluted earnings per share, including the impact of potentially dilutive securities such as stock options, warrants, and convertible notes, and explains why certain securities were anti-dilutive in prior periods | EPS Metric (per share) | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :--------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Basic EPS | $0.29 | $(0.11) | $0.26 | $(0.16) | | Diluted EPS | $0.21 | $(0.11) | $0.18 | $(0.16) | - For the six months ended June 30, 2023, diluted EPS calculations included the dilutive effect of 2024 Notes, stock options, and warrants, whereas these were anti-dilutive in the corresponding **2022 period**[10](index=10&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk) [NOTE 7 – TAXES ON INCOME](index=19&type=section&id=NOTE%207%20%E2%80%93%20TAXES%20ON%20INCOME) This note summarizes the company's income tax expense, effective tax rate, and the impact of the U.S. Tax Cuts and Jobs Act (TCJA) and the release of a valuation allowance on deferred tax assets | Tax Item (in thousands) | 3 Months Ended June 30, 2023 | 6 Months Ended June 30, 2023 | | :---------------------- | :--------------------------- | :--------------------------- | | Current taxes on income | $3,438 | $3,633 | | Deferred taxes on income| $(3,130) | $(3,130) | | **Total taxes on income** | **$308** | **$503** | - The effective tax rate for the six months ended June 30, 2023, was **3%**, up from **0%** in the prior year, primarily due to current taxes on GILTI income and Section 174 of the TCJA, partially offset by the release of a **$3.1 million** valuation allowance on U.S. deferred tax assets[74](index=74&type=chunk)[75](index=75&type=chunk) [NOTE 8 – SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION](index=19&type=section&id=NOTE%208%20%E2%80%93%20SUPPLEMENTARY%20FINANCIAL%20STATEMENT%20INFORMATION) This note provides a detailed breakdown of the 'Accounts payable and accruals – other' line item from the condensed consolidated balance sheets | Account (U.S. dollars in thousands) | June 30, 2023 | December 31, 2022 | | :---------------------------------- | :------------ | :---------------- | | Payroll and related expenses | $1,223 | $1,216 | | Interest Payable | $506 | $719 | | Provision for vacation | $1,526 | $1,404 | | Accrued expenses | $8,608 | $7,478 | | Royalties payable | $1,262 | $781 | | Income tax payable | $3,163 | $530 | | Reserve for deductions from revenue | $1,909 | — | | Property and equipment suppliers | $348 | $143 | | **Total** | **$18,545** | **$12,271** | [NOTE 9 – SUBSEQUENT EVENTS](index=20&type=section&id=NOTE%209%20%E2%80%93%20SUBSEQUENT%20EVENTS) This note discloses cash collections from Pfizer and Chiesi that occurred after the reporting period ended June 30, 2023 - Collected approximately **$1.1 million** from sales to Pfizer on **July 14, 2023**[77](index=77&type=chunk) - Collected approximately **$1.0 million** from Chiesi on **July 7, 2023**[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, operational results, and future outlook, covering recent corporate developments, product pipeline updates, detailed analysis of financial performance, and discussions on liquidity and capital resources [Recent Company Developments](index=22&type=section&id=Recent%20Company%20Developments) This section highlights key corporate events, including regulatory approvals for Elfabrio and changes in authorized common stock - The European Commission granted marketing authorization for Elfabrio in the European Union on **May 5, 2023**[83](index=83&type=chunk) - The FDA approved Elfabrio (pegunigalsidase alfa-iwxj) in the United States on **May 10, 2023**, for the treatment of adult patients with Fabry disease[83](index=83&type=chunk) - Stockholders approved an amendment to increase the authorized common stock from **144,000,000** shares to **185,000,000** shares on **July 13, 2023**[86](index=86&type=chunk) [ProCellEx: Our Proprietary Protein Expression System](index=24&type=section&id=ProCellEx:%20Our%20Proprietary%20Protein%20Expression%20System) This section describes the company's unique plant cell-based protein expression system and its advantages in producing therapeutic proteins - **ProCellEx** is the company's proprietary plant cell-based protein expression system, enabling the production of complex, proprietary, and biologically equivalent recombinant proteins with advantages such as biologic optimization, flexible manufacturing, and elimination of viral contamination risk[87](index=87&type=chunk)[88](index=88&type=chunk) - The company is the first and only to have **two FDA-approved proteins** (Elelyso and Elfabrio) produced through its plant cell-based expression platform[89](index=89&type=chunk) [Products and Product Pipeline](index=25&type=section&id=Products%20and%20Product%20Pipeline) This section provides an overview of the company's commercial products and pipeline candidates, including their regulatory status and market potential [Elfabrio (PRX-102) for the Treatment of Fabry Disease](index=25&type=section&id=Elfabrio%20(PRX-102)%20for%20the%20Treatment%20of%20Fabry%20Disease) This section details the recent regulatory approvals for Elfabrio in the EU and US, its clinical trial results (BALANCE, BRIDGE, BRIGHT studies), and commercialization agreements with Chiesi, highlighting its market potential and safety profile - Elfabrio received EU marketing authorization (**May 5, 2023**) and FDA approval (**May 9, 2023**) for adult Fabry disease patients, with the FDA approval including a boxed warning for hypersensitivity reactions/anaphylaxis[95](index=95&type=chunk) - The global market for Fabry disease was approximately **$2.0 billion** in 2022 and is forecasted to grow at a CAGR of approximately **13%** from 2022-2028[98](index=98&type=chunk) - The BALANCE study demonstrated **comparable efficacy** in eGFR slope between PRX-102 and agalsidase beta, with PRX-102 showing a potentially favorable safety profile including **lower rates of infusion-related reactions** and less premedication use[133](index=133&type=chunk)[134](index=134&type=chunk) - Commercialization agreements with Chiesi include **$50.0 million** in upfront payments, **$45.0 million** in development cost reimbursements, and potential milestone payments of approximately **$1.0 billion**, plus tiered royalties of **15-35% (ex-US)** and **15-40% (US)**[155](index=155&type=chunk) [Elelyso® for the Treatment of Gaucher Disease](index=37&type=section&id=Elelyso%C2%AE%20for%20the%20Treatment%20of%20Gaucher%20Disease) This section describes Elelyso (taliglucerase alfa), the company's first commercial product for Type 1 Gaucher disease, its regulatory approvals, market size, and commercialization agreements with Pfizer and Fiocruz (Brazil) - Elelyso (taliglucerase alfa) was approved by the FDA in **2012** for adult Type 1 Gaucher disease and in **2014** for pediatric patients, and is currently approved in over **20 markets**[163](index=163&type=chunk) - The global market for Gaucher disease was **$1.6 billion** in 2022, with a forecasted CAGR of approximately **3.1%** from 2022-2028[165](index=165&type=chunk) - The company has licensed global rights (excluding Brazil) to Pfizer, who retains **100%** of revenue and reimburses **100%** of direct costs, while maintaining distribution rights in Brazil through a supply and technology transfer agreement with Fiocruz[166](index=166&type=chunk)[168](index=168&type=chunk) [Uricase (PRX-115)](index=38&type=section&id=Uricase%20(PRX-115)) This section introduces PRX-115, a plant cell-expressed recombinant PEGylated uricase under development for severe gout, highlighting its preclinical data and the initiation of its Phase I clinical trial - **PRX-115** is a plant cell-expressed recombinant PEGylated uricase being developed for severe gout, designed to lower uric acid levels with low immunogenicity and increased half-life[169](index=169&type=chunk) - A Phase I First in Human (FIH) clinical trial for PRX-115 was initiated on **March 21, 2023**, with **16 patients** dosed as of the report date, to evaluate safety, pharmacokinetics, pharmacodynamics, and immunogenicity[170](index=170&type=chunk) - Severe gout, affecting an estimated **2%** of the gout patient population with chronic refractory disease, represents an unmet medical need for new effective and safe therapies[172](index=172&type=chunk)[173](index=173&type=chunk) [PRX-119](index=38&type=section&id=PRX-119) This section describes PRX-119, a product candidate for NETs-related diseases, designed as a plant cell-expressed PEGylated recombinant human DNase I to achieve an elongated half-life in circulation - **PRX-119** is a plant cell-expressed PEGylated recombinant human DNase I product candidate designed to elongate half-life in circulation for the treatment of NETs-related diseases[174](index=174&type=chunk) - **NETs** (Neutrophil extracellular traps) formation is implicated in various autoimmune, inflammatory, fibrotic conditions, thrombosis, and cancer, with animal studies suggesting DNase treatment reduces NETs toxicity[174](index=174&type=chunk) [Intellectual Property](index=40&type=section&id=Intellectual%20Property) This section outlines the company's extensive patent portfolio protecting its proprietary technology and products - The company holds a broad portfolio of over **80 patents** in Europe, the United States, Israel, and other countries, along with over **45 pending patent applications**, to protect its proprietary technology and products[176](index=176&type=chunk) [Research & Development](index=40&type=section&id=Research%20%26%20Development) This section describes the company's ongoing efforts in advancing its ProCellEx technology and developing new product candidates - The company continuously works on developing its **ProCellEx** plant cell expression technology and bioreactor system, and on new product candidates for unmet medical needs, utilizing customized modification approaches[177](index=177&type=chunk) [Critical Accounting Policies](index=40&type=section&id=Critical%20Accounting%20Policies) This section confirms no material changes to critical accounting policies and identifies key estimates and assumptions - There have been **no material changes** to the company's critical accounting policies since the Annual Report on Form 10-K for the year ended December 31, 2022[178](index=178&type=chunk) - The most significant estimates and assumptions in financial statement preparation relate to the assessment of **sales reserves** and **valuation allowances**[179](index=179&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the three and six months ended June 30, 2023, compared to prior periods [Three months ended June 30, 2023 compared to the three months ended June 30, 2022](index=40&type=section&id=Three%20months%20ended%20June%2030,%202023%20compared%20to%20the%20three%20months%20ended%20June%2030,%202022) This section analyzes the company's financial performance for the three months ended June 30, 2023, compared to the same period in 2022, highlighting significant revenue growth from Elfabrio approvals, decreased R&D expenses, and increased SG&A | Metric (in thousands) | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | Change ($) | Change (%) | | :-------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Revenues from Selling Goods | $15,075 | $3,382 | $11,693 | 345.7% | | Revenues from License and R&D Services | $20,000 | $5,371 | $14,629 | 272.4% | | Cost of Goods Sold | $6,148 | $4,087 | $2,061 | 50.4% | | Research and Development Expenses | $4,475 | $7,579 | $(3,104) | (41.0%) | | Selling, General and Administrative Expenses | $4,031 | $2,611 | $1,420 | 54.4% | | Financial Expenses, Net | $774 | $(190) (income) | $964 | 507.4% | - The increase in revenues from selling goods was primarily due to an **$11.7 million** increase in sales to Chiesi following the approvals of Elfabrio by the FDA and EMA[10](index=10&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk)[184](index=184&type=chunk)[186](index=186&type=chunk)[187](index=187&type=chunk) - Research and development expenses decreased by **$3.1 million**, or **41%**, primarily due to the completion of the Fabry clinical program and regulatory processes for Elfabrio[184](index=184&type=chunk) [Six months ended June 30, 2023 compared to the six months ended June 30, 2022](index=41&type=section&id=Six%20months%20ended%20June%2030,%202023%20compared%20to%20the%20six%20months%20ended%20June%2030,%202022) This section provides an analysis of the company's financial performance for the six months ended June 30, 2023, compared to the same period in 2022, detailing substantial increases in total revenue, driven by Elfabrio approvals and milestone payments, and a significant reduction in R&D expenses | Metric (in thousands) | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | Change ($) | Change (%) | | :-------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Revenues from Selling Goods | $20,141 | $12,410 | $7,731 | 62.3% | | Revenues from License and R&D Services | $24,522 | $12,428 | $12,094 | 97.3% | | Cost of Goods Sold | $9,233 | $10,121 | $(888) | (8.8%) | | Research and Development Expenses | $10,322 | $16,346 | $(6,024) | (36.9%) | | Selling, General and Administrative Expenses | $7,146 | $5,765 | $1,381 | 23.9% | | Financial Expenses, Net | $1,251 | $226 | $1,025 | 453.5% | - Total revenues from selling goods increased by **$7.7 million**, or **62%**, primarily due to an **$11.5 million** increase in sales to Chiesi, partially offset by decreases in sales to Brazil (**$2.7 million**) and Pfizer (**$1.0 million**)[10](index=10&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk)[194](index=194&type=chunk)[196](index=196&type=chunk)[197](index=197&type=chunk) - Revenues from license and R&D services increased by **$12.1 million**, or **98%**, driven by a **$20.0 million** regulatory milestone payment from Chiesi related to Elfabrio's FDA approval[190](index=190&type=chunk) - Research and development expenses decreased by **$6.0 million**, or **37%**, mainly due to the completion of the Fabry clinical program and related regulatory processes[194](index=194&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, capital raising activities, and ability to meet its financial obligations - The company had **$48.2 million** in cash and cash equivalents as of **June 30, 2023**[199](index=199&type=chunk) - Approximately **$24.9 million** in gross proceeds were raised from the sale of **12,560,150** shares of common stock under the ATM program during the six months ended June 30, 2023[200](index=200&type=chunk) - The total principal amount of outstanding 2024 Notes decreased by approximately **$8.3 million** due to conversions, with **$20.42 million** remaining outstanding as of June 30, 2023[202](index=202&type=chunk)[210](index=210&type=chunk) - The company believes its cash and cash equivalents are sufficient to satisfy capital needs for at least **12 months** from the financial statements' issuance date and is in compliance with all covenants of its 2024 Notes, including maintaining a minimum cash balance of **$7.5 million**[203](index=203&type=chunk)[204](index=204&type=chunk)[207](index=207&type=chunk)[211](index=211&type=chunk) - Net cash generated from operations was **$2.0 million** for the six months ended June 30, 2023, a significant improvement from **$13.2 million** used in the prior year period[205](index=205&type=chunk)[206](index=206&type=chunk) [Effects of Currency Fluctuations](index=47&type=section&id=Effects%20of%20Currency%20Fluctuations) This section addresses the company's exposure to foreign currency exchange rate risks, particularly concerning the New Israeli Shekel - Approximately **43%** of the company's costs, including salaries and office expenses, are incurred in New Israeli Shekels (NIS)[216](index=216&type=chunk) - A **1%** revaluation of the NIS would affect the company's loss before tax by less than **1%**[216](index=216&type=chunk) - The company has **not engaged in hedging transactions** to date but may consider them in the future to mitigate financial exposure from exchange rate fluctuations[216](index=216&type=chunk) [Off-Balance Sheet Arrangements](index=47&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements for the reported periods - The company had **no off-balance sheet arrangements** as of June 30, 2023, and December 31, 2022[214](index=214&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to market risks, primarily focusing on currency exchange risk due to a significant portion of its expenses being incurred in New Israeli Shekels (NIS) while its functional currency is the U.S. dollar - The company's primary market risk is currency exchange risk, as approximately **43%** of its costs are incurred in NIS, while the U.S. dollar is its functional currency[215](index=215&type=chunk)[216](index=216&type=chunk) - The company has **not engaged in hedging transactions** to date but may do so in the future to mitigate the risk of financial exposure from fluctuations in the exchange rate of the U.S. dollar against the NIS[216](index=216&type=chunk) [Item 4. Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) This section reports on the effectiveness of the company's disclosure controls and procedures and internal control over financial reporting, concluding their effectiveness while acknowledging inherent limitations - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2023, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[218](index=218&type=chunk) - There were **no material changes** in the company's internal control over financial reporting during the quarter ended June 30, 2023[220](index=220&type=chunk) - Management acknowledges the **inherent limitations** of all control systems, which can provide only reasonable, not absolute, assurance against error and fraud[219](index=219&type=chunk) [PART II – OTHER INFORMATION](index=49&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This part covers additional disclosures including legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1. Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the company is not currently involved in any material legal proceedings - The company is **not involved in any material legal proceedings**[221](index=221&type=chunk) [Item 1A. Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) This section updates the risk factors, emphasizing potential serious adverse events, undesirable side effects, and post-marketing regulatory requirements for approved products like Elfabrio, which could impact commercial potential - There have been **no material changes** to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2022, except as set forth[222](index=222&type=chunk) - A new risk factor highlights that current or future product candidates may cause **serious adverse events (SAEs)**, **undesirable side effects**, or have other properties that could halt clinical development, prevent/delay regulatory approval, limit commercial potential, or result in negative consequences[223](index=223&type=chunk) - Elfabrio's FDA approval includes a **boxed warning** for hypersensitivity reactions/anaphylaxis and postmarketing requirements, such as a worldwide descriptive study for pregnancy and lactation exposure[223](index=223&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities or use of proceeds to report during the period - **No unregistered sales of equity securities or use of proceeds** to report[224](index=224&type=chunk) [Item 3. Defaults Upon Senior Securities](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities during the reporting period - **No defaults upon senior securities** to report[224](index=224&type=chunk) [Item 4. Mine Safety Disclosures](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - **Mine safety disclosures are not applicable**[224](index=224&type=chunk) [Item 5. Other Information](index=49&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report - **No other information to report**[225](index=225&type=chunk) [Item 6. Exhibits](index=50&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the 10-Q report, including corporate governance documents, stock-related agreements, debt instruments, and certifications - Exhibits include various **corporate documents** (e.g., Certificate of Incorporation amendments, Bylaws), **stock-related forms** (e.g., Restricted Stock Agreement, Stock Option Agreement, Form of Warrant), the **Indenture for the 2024 Notes**, and **certifications** from the Chief Executive Officer and Chief Financial Officer[226](index=226&type=chunk) [Signatures](index=53&type=section&id=Signatures) This section contains the required signatures of the company's principal executive and financial officers, certifying the accuracy of the report - The report is signed by Dror Bashan, President and Chief Executive Officer, and Eyal Rubin, Senior Vice President and Chief Financial Officer, Treasurer and Secretary, on **August 7, 2023**[233](index=233&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 001-33357 (Commission file number) PROTALIX BIOTHERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware __65-0643773__ (State or ...

Protalix Biotherapeutics, Inc. (NYSE:PLX) Q1 2023 Earnings Conference Call May 4, 2023 8:30 AM ET Company Participants Charles Padala - IR Dror Bashan - President, CEO & Director Eyal Rubin - SVP, CFO, Treasurer & Corporate Secretary Conference Call Participants John Vandermosten - Zacks Operator Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics First Quarter 2023 Financial Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the ...

Protalix BioTherapeutics Inc. (NYSE:PLX) Q4 2022 Earnings Conference Call February 27, 2023 8:30 AM ET Company Participants Dror Bashan - President, Chief Executive Officer Eyal Rubin - Senior Vice President, Chief Financial Officer Monique Kosse - LifeSci Advisors Conference Call Participants Boobalan Pachaiyappan - HC Wainwright John Vandermosten - Zacks Small Cap Research Operator Good morning ladies and gentlemen and welcome to the Protalix full year 2022 earnings call. As a reminder, this conference ...