Item 1. Financial Statements
PROTALIX
BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
(Unaudited)
|
|
March 31, 2016
|
|
|
December 31, 2015
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
66,669
|
|
|
$
|
76,374
|
|
Other assets
|
|
|
2,945
|
|
|
|
1,667
|
|
Inventories
|
|
|
5,737
|
|
|
|
5,767
|
|
Assets of discontinued operation
|
|
|
918
|
|
|
|
2,073
|
|
Total current assets
|
|
|
76,269
|
|
|
|
85,881
|
|
|
|
|
|
|
|
|
|
|
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT
|
|
|
1,731
|
|
|
|
1,628
|
|
PROPERTY AND EQUIPMENT, NET
|
|
|
9,310
|
|
|
|
9,744
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
87,310
|
|
|
$
|
97,253
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accruals:
|
|
|
|
|
|
|
|
|
Trade
|
|
$
|
3,890
|
|
|
$
|
3,629
|
|
Other
|
|
|
4,757
|
|
|
|
5,534
|
|
Deferred revenues
|
|
|
504
|
|
|
|
504
|
|
Liabilities of discontinued operation
|
|
|
128
|
|
|
|
1,568
|
|
Total current liabilities
|
|
|
9,279
|
|
|
|
11,235
|
|
|
|
|
|
|
|
|
|
|
LONG TERM LIABILITIES:
|
|
|
|
|
|
|
|
|
Convertible notes
|
|
|
67,906
|
|
|
|
67,796
|
|
Deferred revenues
|
|
|
744
|
|
|
|
744
|
|
Liability for employee rights upon retirement
|
|
|
2,430
|
|
|
|
2,304
|
|
Promissory note
|
|
|
4,301
|
|
|
|
4,301
|
|
Total long term liabilities
|
|
|
75,381
|
|
|
|
75,145
|
|
Total liabilities
|
|
|
84,660
|
|
|
|
86,380
|
|
COMMITMENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’ EQUITY
|
|
|
2,650
|
|
|
|
10,873
|
|
Total liabilities and shareholders’ equity
|
|
$
|
87,310
|
|
|
$
|
97,253
|
|
The accompanying notes are an integral
part of the condensed consolidated financial statements.
PROTALIX
BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
|
|
Three Months Ended
|
|
|
|
March 31, 2016
|
|
|
March 31, 2015
|
|
|
|
|
|
|
|
|
REVENUES
|
|
$
|
679
|
|
|
$
|
1,692
|
|
COST OF REVENUES
|
|
|
(523
|
)
|
|
|
(282
|
)
|
GROSS PROFIT
|
|
|
156
|
|
|
|
1,410
|
|
RESEARCH AND DEVELOPMENT EXPENSES (1)
|
|
|
(7,334
|
)
|
|
|
(6,100
|
)
|
Less – grants
|
|
|
1,309
|
|
|
|
1,128
|
|
RESEARCH AND DEVELOPMENT EXPENSES, NET
|
|
|
(6,025
|
)
|
|
|
(4,972
|
)
|
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2)
|
|
|
(1,995
|
)
|
|
|
(1,822
|
)
|
OPERATING LOSS
|
|
|
(7,864
|
)
|
|
|
(5,384
|
)
|
FINANCIAL EXPENSES
|
|
|
(904
|
)
|
|
|
(1,157
|
)
|
FINANCIAL INCOME
|
|
|
242
|
|
|
|
28
|
|
FINANCIAL EXPENSES – NET
|
|
|
(662
|
)
|
|
|
(1,129
|
)
|
LOSS FROM CONTINUING OPERATIONS
|
|
|
(8,526
|
)
|
|
|
(6,513
|
)
|
Income
(LOSS) FROM DISCONTINUED OPERATIONS
|
|
|
(72
|
)
|
|
|
541
|
|
NET LOSS FOR THE PERIOD
|
|
$
|
(8,598
|
)
|
|
$
|
(5,972
|
)
|
NET LOSS PER SHARE OF COMMON STOCK – BASIC AND DILUTED
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(0.09
|
)
|
|
$
|
(0.07
|
)
|
Income from discontinued operations
|
|
|
(0.00
|
)
|
|
|
0.01
|
|
Net loss per share of common
stock
|
|
$
|
(0.09
|
)
|
|
$
|
(0.06
|
)
|
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE-BASIC AND DILUTED
|
|
|
99,715,625
|
|
|
|
93,200,739
|
|
(1) Includes share-based compensation
|
|
|
238
|
|
|
|
126
|
|
(2) Includes share-based compensation
|
|
|
137
|
|
|
|
293
|
|
The accompanying
notes are an integral part of the condensed consolidated financial statements.
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
CHANGES IN SHAREHOLDERS’ EQUITY (CAPITAL DEFICIENCY)
(U.S. dollars in thousands, except share
data)
(Unaudited)
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
Common
|
|
|
Common
|
|
|
paid–in
|
|
|
Accumulated
|
|
|
|
|
|
|
Stock (1)
|
|
|
Stock
|
|
|
capital
|
|
|
deficit
|
|
|
Total
|
|
|
|
Number of
shares
|
|
|
Amount
|
|
Balance at December 31, 2014
|
|
|
93,603,819
|
|
|
$
|
94
|
|
|
$
|
185,633
|
|
|
$
|
(241,328
|
)
|
|
$
|
(55,601
|
)
|
Changes during the three-month period ended March 31, 2015:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation related to stock options
|
|
|
|
|
|
|
|
|
|
|
202
|
|
|
|
|
|
|
|
202
|
|
Share-based compensation related to restricted stock award, net of forfeitures of 1,667 shares
|
|
|
(1,667
|
)
|
|
|
|
|
|
|
217
|
|
|
|
|
|
|
|
217
|
|
Net loss from continuing operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,513
|
)
|
|
|
(6,513
|
)
|
Net income from discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
541
|
|
|
|
541
|
|
Balance at March 31, 2015
|
|
|
93,602,152
|
|
|
|
94
|
|
|
|
186,052
|
|
|
|
(247,300
|
)
|
|
|
(61,154
|
)
|
Balance at December 31, 2015
|
|
|
99,800,397
|
|
|
$
|
100
|
|
|
$
|
194,064
|
|
|
$
|
(183,291
|
)
|
|
$
|
10,873
|
|
Changes during the three-month period ended March 31, 2016:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation related to stock options
|
|
|
|
|
|
|
|
|
|
|
327
|
|
|
|
|
|
|
|
327
|
|
Share-based compensation related to restricted stock award
|
|
|
7,843
|
|
|
|
|
|
|
|
48
|
|
|
|
|
|
|
|
48
|
|
Net loss from continuing operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,526
|
)
|
|
|
(8,526
|
)
|
Net loss from discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(72
|
)
|
|
|
(72
|
)
|
Balance at March 31, 2016
|
|
|
99,808,240
|
|
|
|
100
|
|
|
|
194,439
|
|
|
|
(191,889
|
)
|
|
|
2,650
|
|
* Represents an amount less than $1.
(1) Common Stock, $0.001 par value; Authorized – as
of March 31, 2016 and 2015 - 150,000,000 shares.
The accompanying
notes are an integral part of the condensed consolidated financial statements.
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(U.S. dollars in thousands)
(Unaudited)
|
|
Three Months Ended
|
|
|
|
March 31, 2016
|
|
|
March 31, 2015
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,598
|
)
|
|
$
|
(5,972
|
)
|
Income (loss) from discontinued operations
|
|
|
(72
|
)
|
|
|
541
|
|
Loss from continuing operations
|
|
|
(8,526
|
)
|
|
|
(6,513
|
)
|
Adjustments required to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Share based compensation
|
|
|
375
|
|
|
|
419
|
|
Depreciation
|
|
|
516
|
|
|
|
616
|
|
Financial expenses, net (mainly exchange differences)
|
|
|
(130
|
)
|
|
|
284
|
|
Changes in accrued liability for employee rights upon retirement
|
|
|
43
|
|
|
|
(4
|
)
|
Gain on amounts funded in respect of employee rights upon retirement
|
|
|
(1
|
)
|
|
|
(1
|
)
|
Amortization of debt issuance costs and debt discount
|
|
|
110
|
|
|
|
110
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Increase in deferred revenues
|
|
|
|
|
|
|
181
|
|
Increase in accounts receivable and other assets
|
|
|
(1,215
|
)
|
|
|
(803
|
)
|
Decrease in inventories
|
|
|
30
|
|
|
|
16
|
|
Decrease in accounts payable and accruals (including long term )
|
|
|
(470
|
)
|
|
|
(472
|
)
|
Net cash used in continuing operations
|
|
|
(9,268
|
)
|
|
|
(6,167
|
)
|
Net cash used in discontinued operations
|
|
|
(357
|
)
|
|
|
(254
|
)
|
Net cash used in operating activities
|
|
$
|
(9,625
|
)
|
|
$
|
(6,421
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
$
|
(251
|
)
|
|
$
|
(99
|
)
|
Amounts funded in respect of employee rights upon retirement, net
|
|
|
(42
|
)
|
|
|
|
|
Net cash used in investing activities
|
|
$
|
(293
|
)
|
|
$
|
(99
|
)
|
|
|
|
|
|
|
|
|
|
EFFECT OF EXCHANGE RATE CHANGES ON CASH
|
|
$
|
213
|
|
|
$
|
(289
|
)
|
NET DECREASE IN CASH AND CASH EQUIVALENTS
|
|
|
(9,705
|
)
|
|
|
(6,809
|
)
|
BALANCE OF CASH AND CASH EQUIVALENTS
AT BEGINNING OF PERIOD
|
|
|
76,374
|
|
|
|
54,767
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD
|
|
$
|
66,669
|
|
|
$
|
47,958
|
|
The accompanying
notes are an integral part of the condensed consolidated financial statements.
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(U.S. dollars in thousands)
(Unaudited)
(Continued) - 2
|
|
Three Months Ended
|
|
|
|
March 31, 2016
|
|
|
March 31, 2015
|
|
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
$
|
320
|
|
|
$
|
194
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$
|
1,553
|
|
|
$
|
1,553
|
|
The accompanying
notes are an integral part of the condensed consolidated financial statements.
PROTALIX BIOTHERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
Protalix BioTherapeutics, Inc.
(collectively with its subsidiaries, the “Company”), and its wholly-owned subsidiaries, Protalix Ltd. and Protalix
B.V. (“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 Uplyso
TM
in Brazil and
certain other Latin American countries and Elelyso
TM
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 current strategy is to develop proprietary
recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications.
The Company’s product pipeline
currently includes, among other candidates:
(1) PRX-102, or alpha-GAL-A, a
therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder;
(2) PRX-106, the Company’s
oral antiTNF product candidate which is being developed as an orally-delivered anti inflammatory treatment using plant cells as
a natural capsule for the expressed protein; and
(3) PRX-110, a proprietary plant
cell recombinant human Deoxyribonuclease 1, or DNase, under development for the treatment of cystic fibrosis, to be administered
by inhalation.
Obtaining marketing approval
with respect to any product candidate in any country is directly dependent on the Company’s ability to comply
with all regulatory requirements to obtain such approvals. The Company cannot reasonably predict the outcome of these
activities.
Since its approval by the
U.S.
Food and Drug Administration
, taliglucerase alfa has been marketed mainly in the United States by Pfizer Inc. (“Pfizer”),
as provided in the exclusive license and supply agreement by and between Protalix Ltd. and Pfizer, which is referred to herein
as the Pfizer Agreement. In October 2015, the Company entered into an Amended and Restated Exclusive License and Supply Agreement
(the “Amended Pfizer Agreement”) which amends and restates the Pfizer Agreement in its entirety. Pursuant to the Amended
Pfizer Agreement, the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization
of Elelyso in exchange for a cash payment equal to $36.0 million. 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 Pfizer Agreement, Pfizer and the Company shared
revenues and expenses for the development and commercialization of Elelyso on a 60%/40% basis globally, excluding Israel and Brazil.
Under the Amended Pfizer Agreement, Pfizer is entitled to all of the revenues, and 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 for taliglucerase alfa.
PROTALIX BIOTHERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued)
:
Fiocruz’s purchases of Uplyso
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 low purchase amounts, the Company is, at this time, continuing to supply Uplyso to Fiocruz
under the Brazil Agreement, and patients continue to be treated with Uplyso in Brazil. The Company is discussing with Fiocruz potential actions that Fiocruz may take to
comply with its purchase obligations and, based on such discussions, the Company will determine what it believes to be the course
of action that is in the best interest of the Company.
Based on its current cash resources and commitments,
the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures
for at least 12 months, although no assurance can be given that it will not need additional funds prior to such time. If there
are unexpected increases in general and administrative expenses or research and development expenses, the Company may need to
seek additional financing.
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, 2015, filed by the Company with the U.S. Securities and Exchange Commission.
The comparative balance sheet at December 31, 2015 has been derived from the audited financial statements at that date.
|
c.
|
Net 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, par value $0.001
per share (the “Common Stock”) outstanding for each period.
Diluted LPS is calculated in
continuing operations. The calculation of diluted LPS does not include 19,380,543 and 19,648,577 shares of Common Stock
underlying outstanding options and restricted shares of Common Stock and shares issuable upon conversion of the convertible
notes (issued in September 2013) for the three months ended March 31, 2015 and 2016, respectively, because the effect would
be anti-dilutive.
PROTALIX BIOTHERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 2 - INVENTORIES
Inventory at March 31, 2016 and December 31,
2015 consisted of the following:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
|
(
U.S. dollars in thousands)
|
|
Raw materials
|
|
$
|
1,635
|
|
|
$
|
1,180
|
|
Finished goods
|
|
|
4,102
|
|
|
|
4,587
|
|
Total inventory
|
|
$
|
5,737
|
|
|
$
|
5,767
|
|
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.
The fair value of the convertible notes as of March
31, 2016 is approximately $46 million based on a level 2 measurement.
NOTE 4 – DISCONTINUED OPERATIONS
The Company accounted for the termination
of the Pfizer Agreement and the sale of the license as a discontinued operation, in accordance with ASU No. 2014-08. The
following assets and liabilities associated with the Company’s discontinued operations, have been segregated and classified
as assets and liabilities of discontinued operations, as appropriate, in the consolidated balance sheets as of December 31,
2015 and March 31, 2016, respectively:
PROTALIX BIOTHERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 4 – DISCONTINUED OPERATIONS
(continued)
:
|
|
March 31, 2016
|
|
|
December 31, 2015
|
|
|
|
(
U.S. dollars in thousands)
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
Accounts receivable - Trade
|
|
$
|
918
|
|
|
$
|
1,993
|
|
Inventories
|
|
|
|
|
|
|
80
|
|
Total current assets of discontinued operation
|
|
|
918
|
|
|
|
2,073
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts payable and accruals:
|
|
|
|
|
|
|
|
|
Other
|
|
$
|
128
|
|
|
$
|
1,568
|
|
Total current liabilities of discontinued operation
|
|
$
|
128
|
|
|
$
|
1,568
|
|
The following summarizes financial information related
to the Company’s discontinued operations in the Company’s consolidated statements of operations for the fiscal quarters
ended March 31, 2015 and March 31, 2016:
|
|
Three Months ended March 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
|
(
U.S. dollars in thousands)
|
|
REVENUES
|
|
$
|
209
|
|
|
$
|
2,700
|
|
COMPANY’S SHARE IN COLLABORATION AGREEMENT
|
|
|
|
|
|
|
705
|
|
COST OF REVENUES
|
|
|
(206
|
)
|
|
|
(2,118
|
)
|
GROSS PROFIT
|
|
|
3
|
|
|
|
1,287
|
|
RESEARCH AND DEVELOPMENT EXPENSES
|
|
|
|
|
|
|
(662
|
)
|
Less –reimbursements
|
|
|
|
|
|
|
7
|
|
RESEARCH AND DEVELOPMENT EXPENSES, NET
|
|
|
|
|
|
|
(655
|
)
|
SELLING, GENERAL AND ADMINISTRATIVE
EXPENSES
|
|
|
(75
|
)
|
|
|
(91
|
)
|
NET INCOME (LOSS) FOR THE YEAR FROM DISCONTINUED
OPERATIONS
|
|
$
|
(72
|
)
|
|
$
|
541
|
|
Item 2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations
You should read the following discussion
and analysis of our financial condition and results of operations together with our financial statements and the consolidated financial
statements and the related notes included elsewhere in this Form 10-Q and in our Annual Report on Form 10-K for the year ended
December 31, 2015. Some of the information contained in this discussion and analysis, particularly with respect to our plans and
strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You
should read “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 for a discussion
of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking
statements contained in the following discussion and analysis.
Overview
We are a biopharmaceutical company focused on the development
and commercialization of recombinant therapeutic proteins based on our proprietary ProCellEx
®
protein expression
system, or ProCellEx. We developed our first commercial drug product, Elelyso
TM
, using our ProCellEx system and we are
now focused on utilizing the system to develop a pipeline of proprietary, clinically superior versions of recombinant therapeutic
proteins that primarily target large, established pharmaceutical markets and that in most cases rely upon known biological mechanisms
of action. With our experience to date, we believe ProCellEx will enable us to develop additional proprietary recombinant proteins
that are therapeutically superior to existing recombinant proteins currently marketed for the same indications. We are now also
applying the unique properties of our ProCellEx system for the oral delivery of therapeutic proteins.
On May 1, 2012, the U.S. Food and Drug Administration, or the
FDA, approved for sale our first commercial product, taliglucerase alfa for injection, an enzyme replacement therapy, or ERT, for
the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. Subsequently, taliglucerase alfa
was approved for marketing by the regulatory authorities of other countries. Taliglucerase alfa is being marketed under the name
Uplyso
TM
in Brazil and certain other Latin American countries, and as Elelyso in
all other territories.
Since
its approval by the FDA, taliglucerase alfa has been marketed mainly in the United States by Pfizer, as provided in the exclusive
license and supply agreement by and between Protalix Ltd., our wholly-owned subsidiary, and Pfizer, which we refer to as the Pfizer
Agreement. In
October 2015, we entered into an Amended and Restated Exclusive License and Supply Agreement, or the Amended
Pfizer Agreement, which amends and restates the Pfizer Agreement in its entirety. Pursuant to the Amended Pfizer Agreement, we
sold to Pfizer our share in the collaboration created under the initial Pfizer Agreement for the commercialization of Elelyso in
exchange for a cash payment equal to $36.0 million. As part of the sale, we agreed to transfer our rights to Elelyso in Israel
to Pfizer, while gaining full rights to Elelyso in Brazil. We will continue to manufacture drug substance for Pfizer, subject to
certain terms and conditions. Under the initial Pfizer Agreement, Pfizer shared revenues and expenses for the development and commercialization
of Elelyso with us on a 60%/40% basis globally, excluding Israel and Brazil. Under the Amended Pfizer Agreement, Pfizer is responsible
for 100% of expenses, and entitled to all revenues globally for Elelyso, excluding Brazil, where we are responsible for all expenses
and retain all revenues.
For the first 10-year period after the execution of the Amended
Pfizer Agreement, we have agreed to sell drug substance to Pfizer for the production of Elelyso, and Pfizer maintains the right
to extend the supply period for up to two additional 30-month periods subject to certain terms and conditions. Any failure to comply
with our supply commitments may subject us to substantial financial penalties, which will have a material adverse effect on our
business, results of operations and financial condition. The Amended Pfizer Agreement also includes customary provisions regarding
cooperation for regulatory matters, patent enforcement, termination, indemnification and insurance requirements.
On
June 18, 2013, we entered into a Supply and Technology Transfer Agreement, or the Brazil Agreement, with
Fiocruz, an arm
of the Brazilian Ministry of Health,
for taliglucerase alfa.
Fiocruz’s purchases of Uplyso to date have been significantly
below certain agreed upon purchase milestones and, accordingly, we have the right to terminate the Brazil Agreement. Notwithstanding
the low purchase amounts, we are, at this time, continuing to supply Uplyso to Fiocruz under the Brazil Agreement, and patients
continue to be treated with Uplyso in Brazil. We are discussing with Fiocruz potential actions that Fiocruz may take to comply
with its purchase obligations and, based on such discussions, we will determine what we believe to be the course of action that
is in the best interest of our company.
We are developing an innovative product pipeline using our ProCellEx
protein expression system. Our product pipeline currently includes, among other candidates:
(1)
PRX-102, or
alpha-GAL-A
, a therapeutic protein candidate for the
treatment of Fabry disease, a rare, genetic lysosomal disorder in humans, currently in an ongoing phase I/II clinical trial. We
expect to commence phase III clinical trials of PRX-102 during the first half of 2016 shortly after we finalize the ongoing special
protocol assessment (SPA) process with the FDA in connection with our proposed protocol for the trial.
(2) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease
1, or AIR DNase
TM
, under development for the treatment of cystic fibrosis, to be administered by inhalation. We have
commenced a phase I clinical trial of AIR DNase in healthy volunteers and intend to initiate a proof of concept efficacy study
in patients in mid year, 2016.
(3)
OPRX-106,
our oral antiTNF product candidate
which is being developed
as
an orally-delivered anti-inflammatory treatment using plant cells as a natural capsule for the expressed protein. We
concluded the phase I clinical trial, which demonstrated that the drug
was safe and well tolerated, showing biological activity in the gut and inducement of regulatory T cells
. We expect to initiate
a
proof of concept efficacy study
in Ulcerative Colitis in mid-year,
2016.
Except
for the rights to commercialize taliglucerase alfa worldwide (other than Brazil), which we licensed to Pfizer, we hold the worldwide
commercialization rights to all of our proprietary development
candidates.
In addition, we continuously evaluate potential strategic marketing partnerships as well as collaboration programs with biotechnology
and pharmaceutical companies and academic research institutes.
Critical Accounting Policies
Our significant accounting policies are more fully described
in Note 1 to our consolidated financial statements appearing in this Quarterly Report. There have not been any changes to
our significant accounting policies since the Annual Report on Form 10-K for the year ended December 31, 2015.
The discussion and analysis of our financial condition and results
of operations is based on our financial statements, which we prepared in accordance with U.S. generally accepted accounting principles.
The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of
assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well
as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments,
including those described in greater detail below. We base our estimates on historical experience and on various other factors
that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates
under different assumptions or conditions.
Discontinued Operations
Pursuant to the Amended Pfizer Agreement,
we sold to Pfizer our share in the collaboration created under the initial Pfizer Agreement for the commercialization of Elelyso.
As part of the sale, we agreed to transfer our rights to Elelyso in Israel to Pfizer while gaining full rights to Elelyso in Brazil.
Under the Amended Pfizer Agreement, Pfizer is responsible for 100% of expenses, and entitled to all of the revenues, globally,
for Elelyso, excluding Brazil where we are responsible for all expenses and retain all revenues. The Amended Pfizer Agreement eliminates
Pfizer’s entitlement to annual payments of up to $12.5 million in relation to commercialization of Elelyso in Brazil. For
further details please see notes 1 and 4 to the financial statements.
Results of Operations
Three months ended March 31, 2016 compared to the three
months ended March 31, 2015
Revenues
We recorded revenues of $679,000 during the three months ended
March 31, 2016, a decrease of $1.0 million, or 60%, from revenues of $1.7 million for the three months ended March 31, 2015.
The decrease resulted primarily from a decrease in the amount of products sold in Brazil.
Cost of Revenues
Cost of revenues was $523,000 for the three months ended March
31, 2016, an increase of $241,000, or 85%, from cost of revenues of $282,000 for the three months ended March 31, 2015.
Research and Development Expenses, Net
Research and development expenses were $6.0 million for
the three months ended March 31, 2016, an increase of $1.0 million, or 21%, from $5.0 million for the three months ended March
31, 2015. The increase resulted primarily from an increase of $495,000 in materials used in our development programs.
We expect research and development expenses
for our various development programs to continue to be our primary expense.
Selling, General and Administrative Expenses
Selling, general and administrative expenses
were $2.0 million for the three months ended March 31, 2016, an increase of $173,000, or 9%, from $1.8 million for the
three months ended March 31, 2015.
Financial Expenses and Income
Financial expenses net were $662,000 for the
three months ended March 31, 2016 compared to financial expenses net of $1.1 million for the three months ended March 31, 2015.
Financial expenses is composed primarily from interest expense of $776,000 for each three-month period for the 4.5% convertible
notes described below.
Liquidity and Capital Resources
Sources of Liquidity
As a result of our significant research and
development expenditures which supersedes our product sales revenue, we have not been profitable and have generated operating losses
from our continuing operations since our inception. To date, we have funded our operations primarily with proceeds equal to $31.3 million
from the sale of shares of convertible preferred and ordinary shares of Protalix Ltd., and an additional $14.1 million in
connection with the exercise of warrants issued in connection with the sale of such shares, through December 31, 2008. In addition,
on October 25, 2007, we generated gross proceeds of $50 million in connection with an underwritten public offering of our
common stock and on each of March 23, 2011 and February 22, 2012, we generated gross proceeds of $22.0 million and $27.2 million,
respectively, in connection with underwritten public offerings of our common stock.
In addition to the foregoing, on September 18, 2013, we completed
a private placement of $69.0 million in aggregate principal amount of 4.50% convertible notes due 2018, or the Notes, including
$9.0 million aggregate principal amount of Notes related to the offering’s initial purchaser’s over-allotment option,
which was exercised in full.
Pfizer
paid Protalix Ltd. $60.0 million as an upfront payment in connection with the execution of the Pfizer Agreement and subsequently
paid to Protalix Ltd. an additional $5.0 million upon Protalix Ltd.’s meeting a certain milestone. Protalix Ltd. also received
a milestone payment of $25.0 in connection with the FDA’s approval of taliglucerase alfa in May 2012.
Pfizer has also
paid Protalix Ltd. $8.3 million in connection with the successful achievement of certain milestones under a clinical development
agreement between Pfizer and Protalix Ltd. In connection with the execution of the Amended Pfizer Agreement, we received a $36.0
million payment from Pfizer, and Pfizer purchased 5,649,079 shares of our common stock for $10.0 million.
We believe that our existing cash and cash
equivalents will be sufficient for at least 12 months. We have based this estimate on assumptions that are subject to change and
may prove to be wrong, and we may be required to use our available capital resources sooner than we currently expect. Because of
the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable
to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical
trials.
Cash Flows
Net cash used in operations was $9.6 million
for the three months ended March 31, 2016. The net loss for the three months ended March 31, 2016 of $8.6 million was further increased
by an increase of $1.2 million in accounts receivable and a decrease of $470,000 in accounts payable, but was partially offset
by depreciation expenses of $516,000. Net cash used in investing activities for the three months ended March 31, 2016 was $293,000
and consisted primarily of purchases of property and equipment.
Net cash used in operations was $6.4 million
for the three months ended March 31, 2015. The net loss for the three months ended March 31, 2015 of $6.0 million was further increased
by an increase of $803,000 in accounts receivable, but was partially offset by depreciation expenses of $616,000. Net cash used
in investing activities for the three months ended March 31, 2015 was $99,000 and consisted primarily of purchases of property
and equipment.
Future Funding Requirements
We expect to continue to incur significant
expenditures in the near future, including significant research and development expenses related primarily to the clinical trials
of PRX-102 and the advancement of our other product candidates into anticipated later stage clinical trials.
Our future capital requirements will depend
on many factors, including our progress in commercializing Uplyso in Brazil, the progress and results of our clinical trials, the
duration and cost of discovery and preclinical development and laboratory testing and clinical trials for our product candidates,
the timing and outcome of regulatory review of our product candidates, the costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing patent claims and other intellectual property rights, the number and development requirements of other
product candidates that we pursue and the costs of commercialization activities, including product marketing, sales and distribution.
We may need to finance our future cash needs
through corporate collaboration, licensing or similar arrangements, public or private equity offerings or debt financings. We currently
do not have any commitments for future external funding. We may need to raise additional funds more quickly if one or more of our
assumptions prove to be incorrect or if we choose to expand our product development efforts more rapidly than we presently anticipate.
We may also decide to raise additional funds even before we need them if the conditions for raising capital are favorable. Any
sale of additional equity or debt securities will likely result in dilution to our shareholders. The incurrence of indebtedness
would result in increased fixed obligations and could also result in covenants that would restrict our operations. Additional equity
or debt financing, grants or corporate collaboration and licensing arrangements may not be available on acceptable terms, if at
all. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate our research and development
programs, reduce our planned commercialization efforts or obtain funds through arrangements with collaborators or others that may
require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize independently.
Effects of Inflation and Currency Fluctuations
Inflation generally affects us by increasing
our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect on our results of operations
during the three months ended March 31, 2016 and March 31, 2015.
Currency fluctuations could affect us through
increased or decreased acquisition costs for certain goods and services. We do not believe currency fluctuations have had a material
effect on our results of operations during the three months ended March 31, 2016 and March 31, 2015.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements
as of each of March 31, 2016 and March 31, 2015.