Protalix BioTherapeutics Reports 2018 Full Year Results and Provides Corporate Update
March 18 2019 - 6:50AM
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 full-year
ended December 31, 2018 and provided a corporate update.
“Throughout 2018 and into early 2019, we significantly advanced
our clinical development program for PRX-102 and, as of today, have
enrolled 127 Fabry disease patients across all of our PRX-102
clinical trials. Most recently, we had a very productive
meeting with the U.S. Food and Drug Administration (FDA) to discuss
the potential filing of an application for accelerated approval
and, at the FDA’s request, we intend to hold a follow up meeting by
the end of the second quarter of 2019 to discuss the data and
content of the potential filing for accelerated approval. We
are very pleased with the collaborative manner our engagement with
the FDA has been to date and cautiously optimistic about the
prospects of our discussions with the agency,” said Mr. Moshe
Manor, Protalix’s President and Chief Executive Officer. “We
are very excited as we move forward into 2019 which could be a
transformational year for us, including the read outs from our
Fabry trials and the potential for establishing the path for
accelerated approval for PRX-102 with the FDA.”
2018 Clinical and Corporate Highlights
Pegunigalsidase alfa (PRX-102) for the treatment of Fabry
Disease
- Recently the Company held a very productive meeting with the
FDA regarding the potential path for accelerated BLA approval for
PRX-102.
- The FDA confirmed that the Company’s PRX-102 program could rely
on surrogate endpoints as part of the basis for a potential
accelerated BLA approval.
- The FDA urged the Company to apply for a follow up Type C
meeting as soon as possible to review with the agency the data and
content of such potential accelerated filing application.
- The discussion with the FDA revolved around the data the
Company has generated from all of its PRX-102 clinical trials to
date, primarily the kidney biopsy results and the eGFR data, that
could be included in the potential application for accelerated
approval.
- In January 2018, the Company received fast track designation
from the FDA for PRX-102.
- In May 2018, the Company reported on the baseline
characteristics for its BALANCE phase III clinical trial for the
treatment of Fabry disease highlighting that PRX-102 is less
inhibited by preexisting neutralizing antibodies compared to
Fabrazyme®, and, therefore, has the potential to attenuate renal
decline and/or stabilize renal function in patients who have not
had an optimal clinical response to Fabrazyme.
- In July 2018, the Company expanded its partnership with Chiesi
Farmaceutici S.p.A., or Chiesi, to include exclusive U.S. rights
for the development and commercialization of PRX-102. The
terms of the agreement include an up-front payment of
$25 million, up to $20 million in development costs, up
to $760 million, in the aggregate, in regulatory and
commercial milestone payments and tiered royalties ranging from 15
to 40%.
- In October 2018, the Company presented positive preliminary
data from its BRIDGE phase III clinical trial for the treatment of
Fabry disease indicating a significant improvement in kidney
function in patients switched from agalsidase alfa (Replagal®) to
PRX-102 at the 1st Canadian Symposium on Lysosomal Diseases.
- In December 2018, the enrollment for the BRIDGE phase III
clinical trial for the treatment of Fabry disease was
completed.
- As of today, the BALANCE trial is over 80% enrolled and the
BRIGHT trial is over 90% enrolled.
- Based on the FDA discussion during our recent meeting we
believe that the potential filing for accelerated approval might be
based on data the Company has already generated in its clinical
trials of PRX-102.
- Currently, substantially all patients treated in the BRIGHT
trial have remained on the once-monthly 2mg/kg dosing
regimen. All of the 13 patients that have completed the
12-month study have opted, together with their treating physician’s
advice, to continue with once-monthly dosing in an extension study
rather than switching back to the 1mg/kg every two weeks
regimen.
Oral antiTNF (OPRX-106) for Ulcerative Colitis
- Throughout 2018, the Company reported positive results from its
phase II clinical trial of OPRX-106 for the treatment of ulcerative
colitis. Final results demonstrated as follows:°
clinical response in 67% of patients and clinical remission in 28%
of patients;° mucosal improvement in 61% of patients, with
33% achieving mucosal healing; and° 89% of the patients
experienced a reduction in Mayo Score, and 61% of the patients
experienced a reduction in endoscopic sub score.
- The Company is evaluating the best path forward which could
include initiating next-stage development internally or collaborate
with potential parties.
Alidornase alfa (PRX-110) for the treatment of Cystic
Fibrosis
- In 2018, the Company received valuable feedback on PRX-110 from
potential partners. While the data generated to date is very
encouraging, further analysis will likely be required to maximize
the potential value of this asset. Given the Company’s
focused cash utilization, it does not plan to conduct further
development of PRX-110 at this time.
Full-Year 2018 Financial Results
- During the preparation of the 2018 annual report, the Company
reevaluated its revenue recognition policies and determined that
certain revenues generated under the Company’s license agreements
should be recognized for accounting purposes. Previously, the
Company did not recognize those revenues.
- The Company recognized revenues from license and R&D
services equal to $2.2 million, $2.8 million and
$11.7 million over the first, second and third quarters of
2018, respectively. The restatement is expected to decrease
the Company’s loss for each of those periods.
- The Company recorded total revenues of $34.2 million
during the year ended December 31, 2018, which was comprised
of $9.0 million from selling goods and $25.2 million from
license revenues, compared to $19.2 million from selling
goods, and $1.8 million from license and R&D services for
the same period of 2017.
- Research and development expenses for the year
ended December 31, 2018, were $33.3 million,
compared to $28.8 million for the same period of 2017.
Selling, general and administrative expenses for the year
ended December 31, 2018 were $10.9 million, compared to
$11.5 million incurred during the same period of 2017.
- Operating loss for the year ended December 31, 2018 was
$19.3 million compared to $34.5 million for the year
ended December 31, 2017.
- For the year ended December 31, 2018, the Company reported
a net loss of $26.5 million, or $0.18 per share, basic and
diluted, compared to $45.4 million, excluding a one-time,
non-cash net charge of $38.1 million in connection with the
remeasurement of a derivative, or $0.35 per share, basic and
diluted, for the same period of 2017.
- On December 31, 2018, the Company had $37.8 million
of cash and cash equivalents, compared to $51.2 million on
December 31, 2017, which is currently projected to fund
operations into mid-2020. As of December 31, 2018, a
total of $57.9 million aggregate principal amount of the Company’s
7.5% convertible notes due November 2021 was outstanding.
Conference Call and Webcast Information
The Company will host a conference call on Monday,
March 18, 2019, 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 9583103.
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 and the final results of a clinical trial may
be different than the preliminary findings for the clinical
trial. Factors that might cause material differences include,
among others: 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 amount and sufficiency
of our cash and cash equivalents; 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 Nanus, Managing Director Solebury Trout 646-378-2927
mnanus@soleburytrout.com
PROTALIX BIOTHERAPEUTICS, INC. CONSOLIDATED
BALANCE SHEETS (U.S. dollars in thousands, except share
and per share amounts) |
|
|
|
December 31, |
|
2017 |
|
2018 |
ASSETS |
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
Cash and cash
equivalents |
$ |
51,163 |
|
|
$ |
37,808 |
|
Accounts
receivable – Trade |
|
1,721 |
|
|
|
4,729 |
|
Other
assets |
|
1,934 |
|
|
|
1,877 |
|
Inventories |
|
7,833 |
|
|
|
8,569 |
|
Total
current assets |
|
62,651 |
|
|
|
52,983 |
|
|
|
|
|
|
|
NON-CURRENT
ASSETS: |
|
|
|
|
|
Funds in
respect of employee right upon retirement |
|
1,887 |
|
|
|
1,758 |
|
Property
and equipment, net |
|
7,676 |
|
|
|
6,390 |
|
Total
assets |
$ |
72,214 |
|
|
$ |
61,131 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES NET
OF CAPITAL DEFICIENCY |
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable and accruals: |
|
|
|
|
|
Trade |
$ |
7,521 |
|
|
$ |
5,211 |
|
Other |
|
9,310 |
|
|
|
10,274 |
|
Contracts
liability |
|
|
|
9,868 |
|
Convertible notes |
|
5,921 |
|
|
|
|
|
Total
current liabilities |
|
22,752 |
|
|
|
25,353 |
|
|
|
|
|
|
|
|
|
|
LONG TERM
LIABILITIES: |
|
|
|
|
|
Convertible notes |
|
46,267 |
|
|
|
47,966 |
|
Contracts
liability |
|
25,015 |
|
|
|
33,027 |
|
Liability
for employee rights upon retirement |
|
2,586 |
|
|
|
2,374 |
|
Other
long term liabilities |
|
5,051 |
|
|
|
5,292 |
|
Total
long term liabilities |
|
78,919 |
|
|
|
88,659 |
|
Total
liabilities |
|
101,671 |
|
|
|
114,012 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
|
|
|
|
CAPITAL
DEFICIENCY: |
|
|
|
|
|
Common
Stock, $0.001 par value: |
|
|
|
|
|
Authorized - as of December 31, 2017 and 2018, 250,000,000
shares; issued and outstanding, respectively - as of
December 31, 2017 and 2018, 143,728,797 shares and 148,382,299
shares, respectively |
|
144 |
|
|
|
148 |
|
Additional paid-in capital |
|
266,495 |
|
|
|
269,524 |
|
Accumulated deficit |
|
(296,096 |
) |
|
|
(322,553 |
) |
Total
capital deficiency |
|
(29,457 |
) |
|
|
(52,881 |
) |
Total
liabilities net of capital deficiency |
$ |
72,214 |
|
|
$ |
61,131 |
|
|
|
|
|
|
|
|
|
|
PROTALIX
BIOTHERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF
OPERATIONS (U.S. dollars in thousands, except share and
per share amounts) |
|
Year ended December 31, |
|
2016 |
|
2017 |
|
2018 |
REVENUES FROM
SELLING GOODS |
$ |
9,199 |
|
|
$ |
19,242 |
|
|
$ |
8,978 |
|
REVENUES FROM
LICENSE AND R&D SERVICES |
|
|
|
1,836 |
|
|
|
25,262 |
|
COST OF GOODS
SOLD |
|
(8,398 |
) |
|
|
(15,231 |
) |
|
|
(9,302 |
) |
RESEARCH AND
DEVELOPMENT EXPENSES |
|
(30,412 |
) |
|
|
(32,170 |
) |
|
|
(35,534 |
) |
Less –
grants |
|
5,804 |
|
|
|
3,336 |
|
|
|
2,204 |
|
RESEARCH AND
DEVELOPMENT EXPENSES, NET |
|
(24,608 |
) |
|
|
(28,834 |
) |
|
|
(33,330 |
) |
SELLING,
GENERAL AND ADMINISTRATIVE EXPENSES |
|
(9,356 |
) |
|
|
(11,530 |
) |
|
|
(10,916 |
) |
OPERATING
LOSS |
|
(33,163 |
) |
|
|
(34,517 |
) |
|
|
(19,308 |
) |
FINANCIAL
EXPENSES |
|
(4,192 |
) |
|
|
(9,725 |
) |
|
|
(7,685 |
) |
FINANCIAL
INCOME |
|
589 |
|
|
|
188 |
|
|
|
536 |
|
LOSS FROM
CHANGE IN FAIR VALUE OF CONVERTIBLE NOTES EMBEDDED
DERIVATIVE |
|
(6,473 |
) |
|
|
(38,061 |
) |
|
|
|
|
|
(LOSS) GAIN ON
EXTINGUISHMENT OF CONVERTIBLE NOTES |
|
14,063 |
|
|
|
(1,325 |
) |
|
|
|
|
|
FINANCIAL (EXPENSES) INCOME – NET |
|
3,987 |
|
|
|
(48,923 |
) |
|
|
(7,149 |
) |
LOSS FROM
CONTINUING OPERATIONS |
|
(29,176 |
) |
|
|
(83,440 |
) |
|
|
(26,457 |
) |
LOSS
FROM DISCONTINUED OPERATIONS |
|
(189 |
) |
|
|
|
|
|
|
|
|
|
|
NET LOSS FOR
THE YEAR |
$ |
(29,365 |
) |
|
$ |
(83,440 |
) |
|
$ |
(26,457 |
) |
|
|
|
|
NET LOSS PER
SHARE OF COMMON STOCK – BASIC AND DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
continuing operations |
$ |
(0.29 |
) |
|
$ |
(0.64 |
) |
|
$ |
(0.18 |
) |
Loss from
discontinued operations |
|
(0.00 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share
of common stock |
$ |
(0.29 |
) |
|
$ |
(0.64 |
) |
|
$ |
(0.18 |
) |
WEIGHTED
AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER
SHARE OF COMMON STOCK, BASIC AND DILUTED |
|
101,387,704 |
|
|
|
131,085,958 |
|
|
|
147,135,182 |
|
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