0001558370-21-007157 | 10-Q | XBRL Viewer | Protalix Biotherapeutics INC

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2021	May 10, 2021
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 31, 2021
Entity File Number	001-33357
Entity Registrant Name	PROTALIX BIOTHERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	65-0643773
Entity Address, Address Line One	2 University Plaza
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Hackensack
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07601
City Area Code	(201)
Local Phone Number	696-9345
Title of 12(b) Security	Common stock, $0.001 par value
Trading Symbol	PLX
Security Exchange Name	NYSEAMER
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		45,382,831
Entity Central Index Key	0001006281
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q1
Amendment Flag	false

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
CURRENT ASSETS:
Cash and cash equivalents	$ 19,830	$ 18,265
Short-term bank deposits	50,600	20,280
Accounts receivable - Trade	4,599	2,000
Other assets	1,754	2,096
Inventories	13,915	13,082
Total current assets	90,698	55,723
NON-CURRENT ASSETS:
Funds in respect of employee rights upon retirement	1,776	1,799
Property and equipment, net	4,828	4,845
Operating lease right of use assets	5,490	5,567
Total assets	102,792	67,934
Accounts payable and accruals:
Trade	6,376	7,221
Other	15,167	13,926
Operating lease liabilities	1,386	1,420
Contracts liability	2,560	5,394
Convertible notes	55,372	54,427
Promissory note		4,086
Total current liabilities	80,861	86,474
LONG TERM LIABILITIES:
Contracts liability	858	1,716
Liability for employee rights upon retirement	2,224	2,263
Operating lease liabilities	4,319	4,467
Other long term liabilities	26	51
Total long term liabilities	7,427	8,497
Total liabilities	88,288	94,971
STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY)	14,504	(27,037)
Total liabilities and stockholders' equity (net of capital deficiency)	$ 102,792	$ 67,934

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)
$ in Thousands

3 Months Ended

Mar. 31, 2021

Mar. 31, 2020

TOTAL REVENUE

$ 11,320

$ 21,646

COST OF GOODS SOLD

^[1]

(4,765)

(3,426)

RESEARCH AND DEVELOPMENT EXPENSES, NET

^[2]

(7,122)

(10,340)

SELLING, GENERAL AND ADMINISTRATIVE EXPENSES

^[3]

(3,138)

(3,187)

OPERATING INCOME (LOSS)

(3,705)

4,693

FINANCIAL EXPENSES

(2,156)

(3,229)

FINANCIAL INCOME

335

203

FINANCIAL EXPENSES - NET

(1,821)

(3,026)

OTHER INCOME

NET INCOME (LOSS) FOR THE PERIOD

$ (5,475)

$ 1,667

EARNINGS (LOSS) PER SHARE OF COMMON STOCK - BASIC AND DILUTED

$ (0.14)

$ 0.10

WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - BASIC AND DILUTED

39,933,972

17,381,074

Goods [Member]

TOTAL REVENUE

$ 4,511

$ 5,031

License and R&D Services [Member]

TOTAL REVENUE

$ 6,809

$ 16,615

[1]	(1) Includes share-based compensation
[2]	(2) Includes share-based compensation
[3]	(3) Includes share-based compensation

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) - USD ($) $ in Thousands	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	Total
Beginning balance at Dec. 31, 2019	$ 15	$ 270,492	$ (340,829)	$ (70,322)
Beginning balance (in shares) at Dec. 31, 2019	14,838,213
Issuance of common stock and warrants, net of issuance cost	$ 18	41,325		41,343
Issuance of common stock and warrants, net of issuance cost (in shares)	17,604,423
Note receivable from issuance of common stock and warrants		(4,000)		(4,000)
Share-based compensation related to stock options		431		431
Net (loss) income for the period			1,667	1,667
Ending balance at Mar. 31, 2020	$ 33	308,248	(339,162)	(30,881)
Ending balance (in shares) at Mar. 31, 2020	32,442,636
Beginning balance at Dec. 31, 2020	$ 35	320,280	(347,352)	(27,037)
Beginning balance (in shares) at Dec. 31, 2020	34,765,280
Issuance of common stock, net of issuance cost	$ 9	37,616		37,625
Issuance of common stock, net of issuance cost (in shares)	8,749,999
Issuance of common stock under the Sales Agreement, net	$ 2	8,573		8,575
Issuance of common stock under the Sales Agreement, net (in shares)	1,867,552
Share-based compensation related to stock options		510		510
Share-based compensation related to restricted stock awards		306		306
Net (loss) income for the period			(5,475)	(5,475)
Ending balance at Mar. 31, 2021	$ 46	$ 367,285	$ (352,827)	$ 14,504
Ending balance (in shares) at Mar. 31, 2021	45,382,831

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)	$ (5,475)	$ 1,667
Adjustments required to reconcile net income (loss) to net cash used in operating activities:
Share-based compensation	816	431
Depreciation	286	376
Financial income, net (mainly exchange differences)	(168)	(241)
Changes in accrued liability for employee rights upon retirement	42	44
Loss (gain) on amounts funded in respect of employee rights upon retirement	(14)	59
Gain on sale of fixed assets	(51)
Amortization of debt issuance costs and debt discount	945	820
Changes in operating assets and liabilities:
Decrease in contracts liability (including non-current portion)	(3,692)	(7,171)
Increase in accounts receivable and other assets	(2,282)	(4,091)
Changes in right of use assets	42	10
Increase in inventories	(833)	(1,333)
Increase in accounts payable and accruals	575	2,611
Decrease in other long term liabilities	(25)	(299)
Net cash used in operating activities	(9,834)	(7,117)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of bank deposits	(37,835)	(35,000)
Proceeds from sale of short-term deposits	7,500
Purchase of property and equipment	(386)	(66)
Proceeds from sale of property and equipment	53
Decrease in restricted deposit	12	22
Amounts funded in respect of employee rights upon retirement, net	(28)	(35)
Net cash used in investing activities	(30,684)	(35,079)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net payment for promissory note	(4,086)
Proceeds from issuance of common stock and warrants, net	37,625	38,607
Proceeds from issuance of common stock under the Sales Agreement, net	8,575
Net cash provided by financing activities	42,114	38,607
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	(31)	(37)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	1,565	(3,626)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	18,265	17,792
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD	19,830	14,166
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Purchase of property and equipment	202	147
Right of use assets obtained in exchange for new operating lease liabilities	122	233
Note receivable from issuance of common stock and warrants, net of issuance cost		$ 2,736
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS
Interest received	$ 136

SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2021

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES

General

Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx^® protein expression system (“ProCellEx”). To date, the Company has successfully developed taliglucerase alfa (marketed under the name BioManguinhos alfataliglicerase in Brazil and certain other Latin American countries and Elelyso^® in the rest of the territories) for the treatment of Gaucher disease that has been approved for marketing in the United States, Brazil, Israel and other markets. The Company has a number of product candidates in varying stages of the clinical development process. The Company’s strategy is to develop proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications.

The most advanced investigational drug in the Company’s product pipeline is pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder. A BLA for PRX-102 for the treatment of adult patients with Fabry disease was submitted to the U.S. Food and Drug Administration (the “FDA”) on May 27, 2020 under the FDA’s Accelerated Approval pathway, which was subsequently accepted by the FDA and granted Priority Review designation. The FDA also indicated in its BLA filing communication letter that it did not plan to hold an advisory committee meeting to discuss the application. On April 28, 2021, the Company, together with its development and commercialization partner for PRX-102, Chiesi Farmaceutici S.p.A. (“Chiesi”), announced that they received a Complete Response Letter (CRL) from the FDA regarding the BLA. The CRL did not report any concerns relating to the potential safety or efficacy of PRX-102 in the submitted data package.

In the CRL, the FDA noted that an inspection of Protalix’s manufacturing facility in Carmiel, Israel, including the FDA’s subsequent assessment of any related FDA findings, is required before the FDA can approve the BLA. Due to travel restrictions, the FDA was unable to conduct the required inspection during the review cycle. The FDA explained in the letter that it will continue to monitor the public health situation as well as travel restrictions, and is actively working to define an approach for scheduling outstanding inspections. With respect to the third-party facility in Europe at which fill and finish processes are performed for PRX-102, due to the novel coronavirus disease, or COVID-19, the FDA reviewed records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act in lieu of a pre-licensing inspection. In the CRL, the FDA stated that it will communicate remaining issues to the facility in order to seek prompt resolution of any pending items.

In addition to the foregoing, in the CRL, the FDA noted that agalsidase beta (Fabrazyme^®), a therapy used to treat Fabry patients, was recently converted to full approval which must be addressed in the context of any potential resubmission seeking accelerated approval of PRX-102. The Company intends to work collaboratively with the FDA to identify the most expeditious pathway to approval, including accelerated approval. Protalix remains confident that it will be able to work with the FDA to resolve these issues and provide a new, alternative drug to Fabry patients. The Company intends to request a Type-A meeting with the FDA, and will provide further updates on next steps after this meeting; however, the Company cannot anticipate the timing of such a meeting nor the additional steps that may be required in connection with any potential resubmission.

In addition to PRX-102, the Company’s product pipeline currently includes, among other candidates:

(1)

alidornase alfa, or PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, which is subject to an exclusive worldwide license agreement with SarcoMed USA, Inc. (“SarcoMed”) for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery;

(2)

PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat refractory gout; and

(3)

PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate being designed to elongate half-life in the circulation for NETs-related diseases.

Obtaining marketing approval with respect to any product candidate in any country is dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals. The Company cannot reasonably predict the outcome of these activities.

On February 10, 2021, the Company entered into an exclusive worldwide license agreement with SarcoMed with respect to PRX-110 for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery. Under the terms of the agreement, SarcoMed will be responsible for the identification and selection of pharmaceutical candidates under the license, and the clinical research and development of such candidates. The Company is entitled to an initial cash payment of $3.5 million, subject to certain conditions, and to additional regulatory and commercial milestone payments and tiered royalties on net sales of products that are commercialized under the license agreement. In addition to the foregoing, the parties agreed to commence negotiation of clinical and commercial supply agreements for alidornase alfa. As part of the arrangement, the parties agreed to negotiate and sign a supply agreement within 60 days of the execution of the license agreement, and SarcoMed has the right to terminate the license agreement if the parties do not successfully do so.

On February 17, 2021, the Company issued and sold 8,749,999 shares of its common stock, par value $0.001 per share (the “Common Stock”), in an underwritten public offering raising gross proceeds of approximately $40.2 million at a price equal to $4.60 per share, before deducting the underwriting discount and estimated expenses of the offering. BofA Securities, Inc. (“BofA Securities”) acted as book-running manager for the offering with Oppenheimer & Co. acting as co-manager.

On March 29, 2021, the Company made a payment of approximately $4.0 million to Pfizer Inc. (“Pfizer”) satisfying the outstanding promissory note payable to Pfizer in full.

On October 1, 2020, the Company entered into an ATM Equity Offering^SM Sales Agreement (the “Sales Agreement”) with BofA Securities as the Company’s sales agent (the “Agent”). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time through the Agent shares of Common Stock having an aggregate offering price of up to $30.0 million (the “ATM Shares”). During 2021 to date, the Company sold 1,867,552 ATM Shares for gross proceeds of $8.8 million. As of the issuance date of the financial statements, the Company has the right to raise an additional $16.2 million of capital under the Sales Agreement.

On October 19, 2017, Protalix Ltd. and Chiesi entered into an Exclusive License and Supply Agreement (the “Chiesi Ex-US Agreement”) pursuant to which Protalix Ltd. granted to Chiesi an exclusive license for all markets outside of the United States to commercialize pegunigalsidase alfa. On July 23, 2018, Protalix Ltd. entered into an Exclusive License and Supply Agreement with Chiesi (the “Chiesi US Agreement”) with respect to the commercialization of pegunigalsidase alfa in the United States.

Under each of the Chiesi Ex-US Agreement and the Chiesi US Agreement (collectively, the “Chiesi Agreements”), Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of each agreement. In addition, under the Chiesi Ex-US Agreement, Protalix Ltd. is entitled to additional payments of up to $25.0 million in pegunigalsidase alfa development costs, capped at $10.0 million per year, and to receive additional payments of up to $320.0 million, in the aggregate, in regulatory and commercial milestone payments. Under the Chiesi US Agreement, Protalix Ltd. is entitled to payments of up to a maximum of $20.0 million to cover development costs for pegunigalsidase alfa, subject to a maximum of $7.5 million per year, and to receive additional payments of up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments. To date, Protalix Ltd. has received the complete amount of development costs to which it is entitled under the Chiesi Agreements.

Under the terms of both of the Chiesi Agreements, Protalix Ltd. will manufacture all of the pegunigalsidase alfa needed under the agreements, subject to certain exceptions, and Chiesi will purchase pegunigalsidase alfa from Protalix, subject to certain terms and conditions. Under the Chiesi Ex-US Agreement, Chiesi is required to make tiered payments of 15%

to 35% of its net sales, depending on the amount of annual sales outside of the United States, as consideration for product supply. Under the Chiesi US Agreement, Chiesi is required to make tiered payments of 15% to 40% of its net sales, depending on the amount of annual sales in the United States, as consideration for product supply.

Subsequent to March 31, 2021, the Company signed a binding term sheet with Chiesi, pursuant to which the parties reached certain agreements including a $10.0 million payment by Chiesi prior to June 30, 2021 in exchange for the reduction of a longer-term regulatory milestone payment set forth in the Chiesi EX-US Agreement by $25.0 million. All other regulatory and commercial milestone payments remain unchanged.

Since its approval by the FDA, taliglucerase alfa has been marketed by Pfizer in accordance with the Pfizer Agreement. In October 2015, Protalix Ltd. and Pfizer entered into an amended exclusive license and supply agreement (the “Amended Pfizer Agreement”) pursuant to which the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso. As part of the sale, the Company agreed to transfer its rights to Elelyso in Israel to Pfizer while gaining full rights to it in Brazil. Under the Amended Pfizer Agreement, Pfizer is entitled to all of the revenues, and is responsible for 100% of expenses globally for Elelyso, excluding Brazil where the Company is responsible for all expenses and retains all revenues.

On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the “Brazil Agreement”) with Fundação Oswaldo Cruz (“Fiocruz”), an arm of the Brazilian Ministry of Health (the “Brazilian MoH”), for taliglucerase alfa. Fiocruz’s purchases of BioManguinhos alfataliglicerase to date have been significantly below certain agreed-upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the termination right, the Company is, at this time, continuing to supply BioManguinhos alfataliglicerase to Fiocruz under the Brazil Agreement, and patients continue to be treated with BioManguinhos alfataliglicerase in Brazil.

COVID-19, which was declared by the World Health Organization to be a global pandemic on March 11, 2020, has had numerous adverse effects on the global economy. To date, the Company’s clinical trials have not been adversely affected by COVID-19, although certain practices the Company has adopted in its offices and facilities in an effort to promote social distancing have resulted in minor delays in the performance of administrative activities outside of the clinical programs. We continue to face uncertainty as to the degree and duration of that impact going forward. The Company does not know the length of time that the pandemic and related disruptions will continue, the impact of governmental regulations or easement of regulations in response to the strengthening or weakening of the pandemic, or the degree of overall potentially permanent changes in consumer behavior that may be caused by the pandemic.

The Company believes that its cash and cash equivalents and bank deposits as of March 31, 2021 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued. The Company expects that such cash and cash equivalents and bank deposits will be sufficient to satisfy the full payment of the principal amount of the Company’s 7.50% convertible secured promissory notes due November 15, 2021 equal to $57.9 million, unless the notes are refinanced, restructured or converted before that date.

Basis of presentation

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year.

These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2020, filed by the Company with the U.S. Securities and Exchange Commission (the “Commission”). The comparative balance sheet at December 31, 2020 has been derived from the audited financial statements at that date. There have been no material changes in our significant accounting policies as described in our consolidated financial statements for the year ended December 31, 2020.

Earnings (loss) per share

Basic and diluted loss per share (“LPS”) are computed by dividing net loss by the weighted average number of shares of the Company’s Common Stock attributable to common stockholders outstanding for each period. The calculation of diluted LPS does not include 10,694,517 and 26,769,693 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of outstanding convertible notes and outstanding warrants for the three months ended March 31, 2020 and 2021, respectively, because their effect would be anti-dilutive.

Revenue recognition

The Company accounts for revenue pursuant to Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, a contract with a customer exists only when: the parties to the contract have approved it and are committed to perform their respective obligations, the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”), the Company can determine the transaction price for the goods or services to be transferred, the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer.

Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer.

Revenues from selling products

The Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery).

Revenue from Chiesi Agreements

The Company has identified two performance obligations in Chiesi agreements as follows: (1) the license and research and development services and (2) the contingent performance obligation regarding future manufacturing.

The Company determined that the license together with the research and development services should be combined into single performance obligation since Chiesi cannot benefit from the license without the research and development services. The research and development services are highly specialized and are dependent on the supply of the drug.

The future manufacturing is contingent on regulatory approvals of the drug and the Company deems these services to be separately identifiable from other performance obligations in the contract. Manufacturing services post-regulatory approval are not interdependent or interrelated with the license and research and development services.

The transaction price was comprised of fixed consideration and variable consideration (capped research and development reimbursements). Under ASC 606, the consideration to which the Company would be entitled upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. The Company estimates variable consideration using the most likely method. Amounts included in the transaction price are recognized only when it is probable that a significant reversal of cumulative revenues will not occur. Prior to recognizing revenue from variable consideration, the Company uses significant judgment to determine the probability of significant reversal of such revenue.

Since the customer benefits from the research and development services as the entity performs the service, revenue from granting the license and the research and development services is recognized over time using the cost-to-cost method. The Company used significant judgment when it determined the costs expected to be incurred upon satisfying the identified performance obligation.

Revenue from additional research and development services ordered by Chiesi, is recognized over time using the cost-to-cost method.

Revenue from R&D services

Revenue from the research and development services is recognized over time using the cost-to-cost method since the customer benefits from the research and development services as the entity performs the service.

FAIR VALUE MEASUREMENT

3 Months Ended

Mar. 31, 2021

FAIR VALUE MEASUREMENT

FAIR VALUE MEASUREMENT

NOTE 3 – FAIR VALUE MEASUREMENT

The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received from the sale of an asset, or paid to transfer a liability, in an orderly transaction between market participants at the measurement date.

The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.

Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.

The fair value of the financial instruments included in the working capital of the Company is usually identical or close to their carrying value.

As of March 31, 2021, the carrying amounts of short-term deposits approximate their fair values due to the stated interest rates, which approximate market rates.

The fair value of the $57.9 million aggregate principal amount of the Company’s outstanding 7.50% 2021 Notes as of March 31, 2021 is approximately $59.8 million based on a Level 3 measurement.

The Company prepared a valuation of the fair value of the Company’s outstanding 2021 Notes (a Level 3 valuation) as of March 31, 2021. The value of these notes was estimated by implementing the binomial model. The liability component was valued based on the Income Approach. The following parameters were used:


	2021 Notes
Stock price (USD)	4.46
Expected term	0.63
Risk free rate	0.05	%
Volatility	71.89	%
Yield	11.54	%

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2021

SIGNIFICANT ACCOUNTING POLICIES

General

In addition to PRX-102, the Company’s product pipeline currently includes, among other candidates:

(1)

(2)

PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat refractory gout; and

(3)

PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate being designed to elongate half-life in the circulation for NETs-related diseases.

On March 29, 2021, the Company made a payment of approximately $4.0 million to Pfizer Inc. (“Pfizer”) satisfying the outstanding promissory note payable to Pfizer in full.

Basis of presentation

Earnings (loss) per share

Revenue recognition

Revenue recognition

Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer.

Revenues from selling products

The Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery).

Revenue from Chiesi Agreements

Revenue from additional research and development services ordered by Chiesi, is recognized over time using the cost-to-cost method.

Revenue from R&D services

SIGNIFICANT ACCOUNTING POLICIES (Details)						1 Months Ended		3 Months Ended
SIGNIFICANT ACCOUNTING POLICIES (Details)	May 14, 2021 USD ($)	Mar. 29, 2021 USD ($)	Feb. 17, 2021 USD ($) $ / shares shares	Feb. 10, 2021 USD ($)	Oct. 01, 2020 USD ($)	Sep. 30, 2020 USD ($)	Oct. 31, 2015	Mar. 31, 2021 USD ($) agreement $ / shares shares	Mar. 31, 2020 $ / shares shares	Dec. 31, 2020 USD ($)	Jul. 23, 2018 USD ($)	Oct. 19, 2017 USD ($)
Significant Accounting Policies [Line Items]
Number of shares issued (in shares) \| shares			8,749,999
Common Stock, Par or Stated Value Per Share \| $ / shares			$ 0.001					$ 0.001	$ 0.001
Gross proceeds			$ 40,200,000					$ 8,575,000
Additional capital that the company can raise								37,625,000
Shares Issued, Price Per Share \| $ / shares			$ 4.60
Payment for promissory note								4,086,000
Convertible Debt, Current								$ 55,372,000		$ 54,427,000
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount \| shares								26,769,693	10,694,517
ATM Shares
Significant Accounting Policies [Line Items]
Gross proceeds								$ 8,800,000
Issuance of common stock under the Sales Agreement, net (in shares) \| shares								1,867,552
Sale of stock, maximum offering price					$ 30,000,000.0
ATM Shares \| Scenario, Plan [Member]
Significant Accounting Policies [Line Items]
Additional capital that the company can raise								$ 16,200,000
Seven Point Five Percentage Convertible Notes [Member] \| Convertible Notes Payable [Member]
Significant Accounting Policies [Line Items]
Interest rate (as a percent)								7.50%
Debt Instrument, Face Amount								$ 57,900,000
Amended Pfizer Agreement [Member]
Significant Accounting Policies [Line Items]
Payment for promissory note		$ 4,000,000.0				$ 430,000
Amended Pfizer Agreement [Member] \| Protalix Bio Therapeutics Incorporation [Member] \| Brazil [Member]
Significant Accounting Policies [Line Items]
Collaborative Arrangement Revenues and Expenses Sharing Percentage							100.00%
Chiesi Agreements [Member]
Significant Accounting Policies [Line Items]
Revenue, Performance Obligation, Number \| agreement								2
Chiesi US Agreement [Member]
Significant Accounting Policies [Line Items]
Additional Amounts Payable To Cover Development Costs											$ 20,000,000.0
Maximum Entitlement Of Development Costs To Cover Per Year											7,500,000
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones											760,000,000.0
Chiesi US Agreement [Member] \| Minimum [Member]
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage								15.00%
Chiesi US Agreement [Member] \| Maximum [Member]
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage								40.00%
Chiesi Ex US Agreement [Member]
Significant Accounting Policies [Line Items]
Additional Amounts Payable To Cover Development Costs												$ 25,000,000.0
Maximum Entitlement Of Development Costs To Cover Per Year												10,000,000.0
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones												320,000,000.0
Chiesi Ex US Agreement [Member] \| Subsequent Event [Member]
Significant Accounting Policies [Line Items]
Agreement Amendment Payment Receivable	$ 10,000,000.0
Change In Amount Receivable For Achievement Of Regulatory And Commercial Milestones	$ (25,000,000.0)
Chiesi Ex US Agreement [Member] \| Minimum [Member]
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage								15.00%
Chiesi Ex US Agreement [Member] \| Maximum [Member]
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage								35.00%
SarcoMed USA, Inc. Agreement [Member]
Significant Accounting Policies [Line Items]
License Agreement, Initial Cash Payment				$ 3,500,000
Term to sign supply agreement				60 days
Chiesi US Agreement and Chiesi Ex US Agreement [Member]
Significant Accounting Policies [Line Items]
Upfront Nonrefundable Non-Creditable Payment Receivable											$ 25,000,000.0	$ 25,000,000.0

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Cost of Sales [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	$ 109
Research and Development Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	210	$ 78
Selling, General and Administrative Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	$ 497	$ 353

INVENTORIES (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
INVENTORIES
Raw materials	$ 3,427	$ 3,347
Work in progress	2,273	2,887
Finished goods	8,215	6,848
Total inventory	$ 13,915	$ 13,082

FAIR VALUE MEASUREMENT - The liability component was valued based on the Income Approach (Details) - 2021 Notes [Member] - Fair Value, Inputs, Level 3 [Member]	Mar. 31, 2021 $ / shares
Measurement Input, Share Price [Member]
Debt Instrument, Measurement Input	4.46
Measurement Input, Expected Term [Member]
Debt Instrument, Measurement Input	0.63
Measurement Input, Risk Free Interest Rate [Member]
Debt Instrument, Measurement Input	0.05
Measurement Input, Price Volatility [Member]
Debt Instrument, Measurement Input	71.89
Measurement Input, Yield [Member]
Debt Instrument, Measurement Input	11.54

FAIR VALUE MEASUREMENT - Additional Information (Details) - Fair Value, Inputs, Level 3 [Member] - Seven Point Five Percentage Convertible Notes [Member] $ in Millions	Mar. 31, 2021 USD ($)
Long-term Debt, Gross	$ 57.9
Debt Instrument, Interest Rate, Stated Percentage	7.50%
Convertible Debt, Fair Value Disclosures	$ 59.8

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) (Parenthetical) - $ / shares	Mar. 31, 2021	Mar. 31, 2020
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKOLDERS' EQUITY (CAPITAL DEFICIENCY)
Common Stock, Par or Stated Value Per Share	$ 0.001	$ 0.001
Common Stock, Shares Authorized	120,000,000	120,000,000

REVENUES - Company's disaggregation of revenues (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Revenues	$ 11,320	$ 21,646
Goods [Member]
Revenues	4,511	5,031
Goods [Member] \| Pfizer [Member]
Revenues	4,511	2,016
Goods [Member] \| Brazil [Member]
Revenues		3,015
License and R&D Services [Member]
Revenues	$ 6,809	16,615
License and R&D Services [Member] \| Chiesi US Agreement and Chiesi Ex US Agreement [Member] \| Change in Accounting Method Accounted for as Change in Estimate [Member]
Revenues		$ 6,700

PROMISSORY NOTE (Details) - USD ($)		1 Months Ended	3 Months Ended
PROMISSORY NOTE (Details) - USD ($)	Mar. 29, 2021	Sep. 30, 2020	Mar. 31, 2021	Dec. 31, 2020
Promissory note				$ 4,086,000
Repayments of Notes Payable			$ 4,086,000
Amended Pfizer Agreement [Member]
Promissory note		$ 4,300,000
Repayments of Notes Payable	$ 4,000,000.0	$ 430,000