Protalix BioTherapeutics Reports 2018 Third Quarter Results and Provides Corporate Update
November 07 2018 - 7:00AM
Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a
biopharmaceutical company focused on the development and
commercialization of recombinant therapeutic proteins expressed
through its proprietary plant cell-based expression system,
ProCellEx®, today announced its financial results for the three
months and nine months ended September 30, 2018, and provided a
corporate update.
“In the third quarter we achieved two important milestone events
for pegunigalsidase alfa, or PRX-102, our differentiated enzyme
replacement therapy in development for the treatment of Fabry
disease. First, we expanded our partnership with Chiesi
Farmaceutici S.p.A. to include exclusive rights to commercialize
and develop PRX-102 in the United States, which significantly
strengthened our financial position. Second, we reported
positive preliminary results from our BRIDGE study on key kidney
function,” commented Moshe Manor, Protalix’s President and Chief
Executive Officer. “Based on the promising preliminary BRIDGE
study results, and taking into account the newly issued guidance
from the U.S. Food and Drug Administration (FDA), we plan to engage
with the FDA during the first half of 2019 to discuss the most
optimal regulatory path forward for PRX-102. While we
continue to enroll patients in all of our currently ongoing Fabry
disease studies, we believe that with over 110 Fabry patients
enrolled across the studies included in our PRX-102 clinical
program to date, we have a sufficient number of patients for
expedited review, including filing an application for accelerated
approval,” continued Mr. Manor.
2018 Third Quarter Highlights
- Presented preliminary positive data from the BRIDGE study
showing Improvement in kidney function in patients switched from
agalsidase alfa (Replagal®) to pegunigalsidase alfa and further
showing the reversal of a deterioration trend in kidney function to
an improvement trend when switched.
- Expanded partnership with Chiesi Farmaceutici S.p.A., or
Chiesi, to include U.S. rights for the development and
commercialization of PRX-102. Terms of the agreement included
an up-front payment of $25 million, up to $20 million in
development costs and tiered royalties ranging from 15-40% of net
sales.
- Expanded our Board of Directors with the addition of Mr. David
Granot as an independent director.
- Continued exploring the potential for partnership opportunities
mainly for OPRX-106, and for PRX-110. In parallel, the
Company is exploring the option of conducting a controlled phase
IIb study of OPRX-106 for the treatment of ulcerative colitis in
order to maximize the value of this asset in a manner that will
best serve the stockholders’ interest.
Financial Results for the Nine Months ended September
30, 2018
- The Company reported a net loss of $36.2 million, or $0.25
per share, basic and diluted for the nine-month period ended
September 30, 2018 compared to a net loss of
$32.1 million, or $0.25 per share, basic and diluted for the
same period of 2017 excluding remeasurement of a derivative.
- The Company recorded total revenues of $7.2 million for
the nine-month period ended September 30, 2018, compared to
$16.8 million for the same period of 2017. The decrease
resulted primarily from decreased shipments of alfataliglicerase to
Brazil despite the increase in the number of patients treated with
alfataliglicerase, and decreased sales of drug substance to
Pfizer.
- The $25.0 million in proceeds received from Chiesi during the
three-month period ended September 30, 2018 as an upfront
payment were not recorded as revenues, and were deferred according
to the revenue recognition rules of U.S. generally accepted
accounting principles. Such proceeds should be recorded upon
the commencement of commercial manufacturing. The same
accounting treatment was applied to the $25.0 million upfront
payment received by the Company in the fourth quarter of 2017, and
the $11.8 million of research and development reimbursement
payments the Company has received from Chiesi to date.
- Research and development expenses were $23.8 million for
the nine-month period ended September 30, 2018, compared to
$19.8 million for the same period of 2017.
- Selling, general and administrative expenses were
$7.3 million for the nine-month period ended
September 30, 2018 compared to $8.2 million for the same
period of 2017.
- As of September 30, 2018, the Company had
$41.9 million of cash and cash equivalents. With the
expected decrease in cash consumption resulting primarily from the
Company’s U.S. license transaction with Chiesi, the Company expects
the cash balance to fund the Company through significant regulatory
achievements of PRX-102.
Conference Call and Webcast Information
The Company will host a conference call on Wednesday,
November 7, 2018 at 8:30 am ET to review the clinical,
corporate and financial highlights.
To participate in the conference call, please dial the following
numbers prior to the start of the call: United States:
+1-844-358-6760; International: +1-478-219-0004. Conference
ID number 8567317.
The conference call will also be broadcast live and available
for replay for two weeks on the Company's website,
www.protalix.com, in the Events Calendar of the Investors
section. Please access the Company's website at least 15
minutes ahead of the conference to register, download, and install
any necessary audio software.
About Protalix BioTherapeutics,
Inc.
Protalix is a biopharmaceutical company focused on the
development and commercialization of recombinant therapeutic
proteins expressed through its proprietary plant cell-based
expression system, ProCellEx®. Protalix’s unique expression
system presents a proprietary method for developing recombinant
proteins in a cost-effective, industrial-scale manner.
Protalix’s first product manufactured by ProCellEx, taliglucerase
alfa, was approved for marketing by the U.S. Food and Drug
Administration (FDA) in May 2012 and, subsequently, by the
regulatory authorities of other countries. Protalix has
licensed to Pfizer Inc. the worldwide development and
commercialization rights for taliglucerase alfa,
excluding Brazil, where Protalix retains full rights.
Protalix’s development pipeline includes the following product
candidates: pegunigalsidase alfa, a modified version of the
recombinant human alpha-GAL-A protein for the treatment of Fabry
disease; OPRX-106, an orally-delivered anti-inflammatory treatment;
alidornase alfa for the treatment of Cystic Fibrosis; and
others. Protalix has partnered with Chiesi Farmaceutici
S.p.A., both in the United States and outside the United States,
for the development and commercialization of pegunigalsidase
alfa.
Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, all such statements are forward-looking, and
are made pursuant to the safe-harbor provisions of the Private
Securities Litigation Reform Act of 1995. The terms “expect,”
“anticipate, “believe,” “estimate,” “project,” “plan,” “should” and
“intend” and other words or phrases of similar import are intended
to identify forward-looking statements. These forward-looking
statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ
materially from the statements made. These statements are
based on our current beliefs and expectations as to such future
outcomes. Drug discovery and development involve a high
degree of risk. Factors that might cause material differences
include, among others: failure or delay in the commencement or
completion of our preclinical and clinical trials which may be
caused by several factors, including: risks that the FDA will not
accept an application for accelerated approval of PRX-102 with the
data generated to date or will request additional data or other
conditions of our submission of any application for accelerated
approval of PRX-102; slower than expected rates of patient
recruitment; unforeseen safety issues; determination of dosing
issues; lack of effectiveness during clinical trials; inability to
monitor patients adequately during or after treatment; inability or
unwillingness of medical investigators and institutional review
boards to follow our clinical protocols; and lack of sufficient
funding to finance clinical trials; the risk that the results of
the clinical trials of our product candidates will not support our
claims of superiority, safety or efficacy, that our product
candidates will not have the desired effects or will be associated
with undesirable side effects or other unexpected characteristics;
risks related to our ability to maintain and manage our
relationship with Chiesi Farmaceutici and any other collaborator,
distributor or partner; risks related to the ultimate purchase by
Fundação Oswaldo Cruz of alfataliglicerase pursuant to
the stated purchase intentions of the Brazilian Ministry of
Health of the stated amounts, if at all; risks related to the
successful conclusion of our negotiations with the Brazilian
Ministry of Health regarding the purchase of alfataliglicerase
generally; risks related to our commercialization efforts for
alfataliglicerase in Brazil; risks relating to the compliance
by Fundação Oswaldo Cruz with its purchase obligations
and related milestones under our supply and technology transfer
agreement; risks related to the amount and sufficiency of our cash
and cash equivalents; risks related to the amount of our future
revenues, operations and expenditures; the risk that despite the
FDA’s grant of fast track designation for pegunigalsidase alfa for
the treatment of Fabry disease, we may not experience a faster
development process, review or approval compared to applications
considered for approval under conventional FDA procedures; risks
related to the FDA’s ability to withdraw the fast track designation
at any time; risks relating to our ability to make scheduled
payments of the principal of, to pay interest on or to refinance
our outstanding notes or any other indebtedness; our dependence on
performance by third party providers of services and supplies,
including without limitation, clinical trial services; delays in
our preparation and filing of applications for regulatory approval;
delays in the approval or potential rejection of any applications
we file with the FDA or other health regulatory
authorities, and other risks relating to the review process; our
ability to identify suitable product candidates and to complete
preclinical studies of such product candidates; the inherent risks
and uncertainties in developing drug platforms and products of the
type we are developing; the impact of development of competing
therapies and/or technologies by other companies and institutions;
potential product liability risks, and risks of securing adequate
levels of product liability and other necessary insurance coverage;
and other factors described in our filings with the U.S.
Securities and Exchange Commission. The statements in this
press release are valid only as of the date hereof and we disclaim
any obligation to update this information, except as may be
required by law.
Investor Contact
Marcy NanusSolebury Trout 646-378-2927
mnanus@soleburytrout.com
PROTALIX BIOTHERAPEUTICS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in
thousands) |
|
|
|
September 30,
2018 |
|
|
December 31,
2017 |
|
|
|
(Unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
41,868 |
|
|
$ |
51,163 |
|
Accounts receivable – Trade |
|
|
4,894 |
|
|
|
1,721 |
|
Other assets |
|
|
2,619 |
|
|
|
1,934 |
|
Inventories |
|
|
7,959 |
|
|
|
7,833 |
|
Total current assets |
|
$ |
57,340 |
|
|
$ |
62,651 |
|
DEFERRED ASSET |
|
$ |
1,450 |
|
|
|
|
|
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON
RETIREMENT |
|
|
1,779 |
|
|
|
1,887 |
|
PROPERTY AND EQUIPMENT, NET |
|
|
6,628 |
|
|
|
7,676 |
|
Total assets |
|
$ |
67,197 |
|
|
$ |
72,214 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES NET OF CAPITAL DEFICIENCY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accruals: |
|
|
|
|
|
|
|
|
Trade |
|
$ |
4,388 |
|
|
$ |
7,521 |
|
Other |
|
|
10,163 |
|
|
|
9,310 |
|
Convertible notes |
|
|
|
|
|
|
5,921 |
|
Total current liabilities |
|
$ |
14,551 |
|
|
$ |
22,752 |
|
|
|
|
|
|
|
|
|
|
LONG TERM LIABILITIES: |
|
|
|
|
|
|
|
|
Convertible notes |
|
|
47,320 |
|
|
|
46,267 |
|
Deferred revenues |
|
|
61,780 |
|
|
|
26,851 |
|
Liability for employee rights upon retirement |
|
|
2,386 |
|
|
|
2,586 |
|
Other long term liabilities |
|
|
6,154 |
|
|
|
5,051 |
|
Total long term liabilities |
|
$ |
117,640 |
|
|
$ |
80,755 |
|
Total liabilities |
|
$ |
132,191 |
|
|
$ |
103,507 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CAPITAL DEFICIENCY |
|
|
(64,994 |
) |
|
|
(31,293 |
) |
Total liabilities net of capital deficiency |
|
$ |
67,197 |
|
|
$ |
72,214 |
|
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S.
dollars in thousands, except share and per share data)
(Unaudited) |
|
Nine Months Ended |
Three Months Ended |
|
September 30, 2018 |
September 30, 2017 |
September 30, 2018 |
September 30, 2017 |
REVENUES |
$ |
7,222 |
|
$ |
16,773 |
|
$ |
663 |
|
$ |
7,526 |
|
COST OF
REVENUES |
|
(7,024 |
) |
|
(13,677 |
) |
|
(1,917 |
) |
|
(6,066 |
) |
GROSS PROFIT
(LOSS) |
|
198 |
|
|
3,096 |
|
|
(1,254 |
) |
|
1,460 |
|
RESEARCH AND
DEVELOPMENT EXPENSES (1) |
|
(25,565 |
) |
|
(22,389 |
) |
|
(10,803 |
) |
|
(7,118 |
) |
Less – grants |
|
1,810 |
|
|
2,545 |
|
|
732 |
|
|
729 |
|
RESEARCH AND
DEVELOPMENT EXPENSES,
NET |
|
(23,755 |
) |
|
(19,844 |
) |
|
(10,071 |
) |
|
(6,389 |
) |
SELLING,
GENERAL AND ADMINISTRATIVE EXPENSES
(2) |
|
(7,294 |
) |
|
(8,187 |
) |
|
(2,638 |
) |
|
(2,836 |
) |
OPERATING
LOSS |
|
(30,851 |
) |
|
(24,935 |
) |
|
(13,963 |
) |
|
(7,765 |
) |
FINANCIAL
EXPENSES |
|
(5,824 |
) |
|
(8,809 |
) |
|
(1,811 |
) |
|
(3,680 |
) |
FINANCIAL
INCOME |
|
437 |
|
|
1,670 |
|
|
230 |
|
|
8 |
|
LOSS FROM
CHANGE IN FAIR VALUE OF |
|
|
|
|
|
|
CONVERTIBLE NOTES EMBEDDED DERIVATIVE |
|
|
|
|
(38,061 |
) |
|
|
|
|
|
|
FINANCIAL
EXPENSES, NET |
|
(5,387 |
) |
|
(45,200 |
) |
|
(1,581 |
) |
|
(3,672 |
) |
NET LOSS FOR
THE PERIOD |
|
(36,238 |
) |
|
(70,135 |
) |
|
(15,544 |
) |
|
(11,437 |
) |
NET LOSS PER
SHARE OF COMMON STOCK |
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED |
$ |
(0.25 |
) |
$ |
(0.55 |
) |
$ |
(0.10 |
) |
$ |
(0.09 |
) |
WEIGHTED
AVERAGE NUMBER OF SHARES OF |
|
|
|
|
|
|
|
|
|
|
|
|
COMMON STOCK USED IN COMPUTING |
|
|
|
|
|
|
|
|
|
|
|
|
LOSS PER SHARE – BASIC AND |
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
146,752,355 |
|
|
128,223,722 |
|
|
148,187,513 |
|
|
132,549,001 |
|
(1) Includes share-based compensation |
$ |
54 |
|
$ |
163 |
|
$ |
14 |
|
$ |
43 |
|
(2) Includes share-based compensation |
$ |
42 |
|
$ |
128 |
|
$ |
8 |
|
$ |
32 |
|
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