Protalix BioTherapeutics Reports Second Quarter 2019 Results and Provides Corporate Update
August 08 2019 - 6:05AM
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 six-month
period ended June 30, 2019 and provided a corporate update.
“We are very optimistic about our interactions with
the U.S. Food and Drug Administration over the second quarter
of 2019, which resulted in our decision to, together with our
partner Chiesi Farmaceutici, begin preparing a biologics license
application for pegunigalsidase alfa for the treatment of Fabry
disease, which we expect to submit in the first quarter of 2020
through the FDA’s Accelerated Approval pathway,” said Mr. Dror
Bashan, Protalix’s President and Chief Executive Officer. “We
are now focused on completing the anticipated filing.”
Second Quarter 2019 and Recent Clinical and
Corporate Highlights
- The Company, together with its collaboration partner, Chiesi
Farmaceutici S.p.A, or Chiesi, announced that, following a series
of meetings and correspondence with the U.S. Food and Drug
Administration (FDA), they plan to file a biologics license
application (BLA) for pegunigalsidase alfa, or PRX-102, for the
treatment of Fabry disease via the FDA’s Accelerated Approval
pathway.
- The Company and Chiesi have initiated preparations for the BLA
submission based on data from the completed Phase I/II
clinical trials of pegunigalsidase alfa and the ongoing
Phase III BRIDGE clinical trial, and expect to hold a pre-BLA
meeting with the FDA in the fourth quarter of 2019.
- Enrollment completed in the Phase III BRIGHT clinical
trial of pegunigalsidase alfa for the treatment of Fabry disease,
via intravenous (IV) infusions of 2 mg/kg administered every 4
weeks.
- To date, substantially all patients enrolled in the BRIGHT
clinical trial remain on the 4‑week dosing regimen, and all of the
patients that completed the study opted, with the advice of the
treating physician, to continue treatment under the 4‑week dosing
regimen in a long-term extension study.
- The Company’s Phase III BALANCE clinical trial of
pegunigalsidase alfa for the treatment of Fabry disease is
currently 95% enrolled.
- To date, more than 55 patients are being treated in the
Company’s various extension studies after opting to continue
treatment with pegunigalsidase alfa after completion of an initial
study.
- Results from the Company’s Phase I/II clinical trial of
pegunigalsidase alfa were published in an article in the May 2019
edition of the Journal of Inherited Metabolic Disease.
Financial Results for the Six Months Ended
June 30, 2019
- The Company recorded total revenues of $22.7 million for
the six-month period ended June 30, 2019, compared
to $11.6 million for the same period of 2018. The
increase is primary attributable to the recognition of
$15.7 million of license revenues for the six-month period
ended June 30, 2019 compared to the recognition of
$5.0 million in the same period of 2018.
- Research and development expenses, net were $25.0 million
for the six months ended June 30, 2019, compared to $13.7
million for the same period in 2018. The increase is mainly
due to advancement of the Phase III studies in PRX-102.
- Selling, general and administrative expenses for the six months
ended June 30, 2019 were $4.3 million, compared to
$4.7 million for the same period in 2018.
- Net loss for the six months ended June 30, 2019 was
$15.0 million, or $0.10 per share, basic and diluted, compared
to a net loss of $15.7 million, or $0.11 per share, basic and
diluted, for the six months ended June 30, 2018.
- On June 30, 2019, the Company had $25.1 million of
cash and cash equivalents.
- If the BLA submitted for pegunigalsidase alfa is approved by
the FDA, the Company will be entitled to a milestone payment, which
is currently expected to be payable around the fourth quarter of
2020 or first quarter of 2021.
- Based on the Company’s current cash resources and commitments,
the Company believes it may not be able to maintain its current
planned development activities and the corresponding level of
expenditures for at least 12 months from the date of approval of
the financial statements as of June 30, 2019 in the absence of
a refinancing or restructuring of its existing obligations.
These factors raise substantial doubt as to the Company’s ability
to continue as a going concern. Additional information will
be included in Note 1(a) and other parts of the Company’s Quarterly
Report on Form 10-Q which will be filed the day of the
earnings call. The Company is evaluating various financing
alternatives and related transactions.
- The Company’s management is in the process of evaluating
refinancing and restructuring alternatives, including a
restructuring of its outstanding convertible notes, and related
transactions. However, there is no certainty about the
Company’s ability to obtain such funding.
Conference Call and Webcast Information
The Company will host a conference call on Thursday,
August 8, 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 1497319.
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; risks related to our ability to continue as a
going concern absent access to sources of capital we will need to
finance future research and development activities, general and
administrative expenses and working capital; risks related to any
capital raising transactions we may effect in the public or private
equity markets to raise capital to finance future research and
development activities, general and administrative expenses and
working capital; 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
Alan Lada, Vice President Solebury Trout 617-221-8006
alada@soleburytrout.com
PROTALIX BIOTHERAPEUTICS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(U.S. dollars in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2019(Unaudited) |
|
|
|
December 31,
2018 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
25,096 |
|
|
$ |
37,808 |
|
Accounts receivable – Trade |
|
|
7,256 |
|
|
|
4,729 |
|
Other assets |
|
|
2,248 |
|
|
|
1,877 |
|
Inventories |
|
|
6,998 |
|
|
|
8,569 |
|
Total current assets |
|
$ |
41,598 |
|
|
$ |
52,983 |
|
|
|
|
|
|
|
|
|
|
FUNDS IN RESPECT OF
EMPLOYEE RIGHTS UPON RETIREMENT |
|
$ |
1,871 |
|
|
$ |
1,758 |
|
PROPERTY AND
EQUIPMENT, NET |
|
|
5,917 |
|
|
|
6,390 |
|
OPERATING LEASE RIGHT
OF USE ASSETS |
|
|
5,856 |
|
|
|
- |
|
Total assets |
|
$ |
55,242 |
|
|
$ |
61,131 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES NET OF
CAPITAL DEFICIENCY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
|
|
|
|
Accounts payable and accruals: |
|
|
|
|
|
|
|
|
Trade |
|
$ |
6,728 |
|
|
$ |
5,211 |
|
Other |
|
|
10,496 |
|
|
|
10,274 |
|
Operating lease
liabilities |
|
|
1,227 |
|
|
|
- |
|
Contracts
liability |
|
|
7,542 |
|
|
|
9,868 |
|
Total current liabilities |
|
$ |
25,993 |
|
|
$ |
25,353 |
|
|
|
|
|
|
|
|
|
|
LONG TERM
LIABILITIES: |
|
|
|
|
|
|
|
|
Convertible notes |
|
$ |
49,401 |
|
|
$ |
47,966 |
|
Contracts liability |
|
|
34,911 |
|
|
|
33,027 |
|
Liability for employee rights upon retirement |
|
|
2,508 |
|
|
|
2,374 |
|
Operating lease liabilities |
|
|
4,566 |
|
|
|
- |
|
Other long term liabilities |
|
|
5,348 |
|
|
|
5,292 |
|
Total long term liabilities |
|
$ |
96,734 |
|
|
$ |
88,659 |
|
Total liabilities |
|
$ |
122,727 |
|
|
$ |
114,012 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CAPITAL
DEFICIENCY |
|
$ |
(67,485 |
) |
|
$ |
(52,881 |
) |
Total liabilities net of capital deficiency |
|
$ |
55,242 |
|
|
$ |
61,131 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROTALIX BIOTHERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(U.S. dollars in thousands, except per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
Three Months Ended |
|
|
|
June 30,
2019 |
|
|
June 30, 2018 |
|
|
June 30,
2019 |
|
|
June 30, 2018 |
|
REVENUES FROM SELLING GOODS |
|
$ |
6,960 |
|
|
$ |
6,559 |
|
|
$ |
3,430 |
|
|
$ |
2,006 |
|
REVENUES FROM LICENSE
AND |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D
SERVICES |
|
|
15,726 |
|
|
|
4,993 |
|
|
|
8,817 |
|
|
|
2,832 |
|
COST OF GOODS
SOLD |
|
|
(4,740 |
) |
|
|
(5,107 |
) |
|
|
(2,695 |
) |
|
|
(2,183 |
) |
RESEARCH AND
DEVELOPMENT |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES (1) |
|
|
(25,024 |
) |
|
|
(14,762 |
) |
|
|
(13,323 |
) |
|
|
(7,476 |
) |
Less -
grants |
|
|
3 |
|
|
|
1,078 |
|
|
|
|
|
|
|
235 |
|
RESEARCH AND
DEVELOPMENT |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES, NET |
|
|
(25,021 |
) |
|
|
(13,684 |
) |
|
|
(13,323 |
) |
|
|
(7,241 |
) |
SELLING, GENERAL
AND |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ADMINISTRATIVE EXPENSES (2) |
|
|
(4,298 |
) |
|
|
(4,656 |
) |
|
|
(2,068 |
) |
|
|
(2,158 |
) |
OPERATING
LOSS |
|
|
(11,373 |
) |
|
|
(11,895 |
) |
|
|
(5,839 |
) |
|
|
(6,744 |
) |
FINANCIAL
EXPENSES |
|
|
(3,827 |
) |
|
|
(4,013 |
) |
|
|
(1,907 |
) |
|
|
(1,793 |
) |
FINANCIAL
INCOME |
|
|
193 |
|
|
|
207 |
|
|
|
3 |
|
|
|
75 |
|
FINANCIAL
EXPENSES, NET |
|
|
(3,634 |
) |
|
|
(3,806 |
) |
|
|
(1,904 |
) |
|
|
(1,718 |
) |
NET LOSS FOR
THE PERIOD |
|
$ |
(15,007 |
) |
|
$ |
(15,701 |
) |
|
$ |
(7,743 |
) |
|
$ |
(8,462 |
) |
NET LOSS PER
SHARE OF COMMON |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCK-BASIC
AND DILUTED |
|
$ |
(0.10 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.06 |
) |
WEIGHTED AVERAGE
NUMBER OF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHARES OF
COMMON STOCK |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
USED IN
COMPUTING LOSS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PER SHARE –
BASIC AND DILUTED |
|
|
148,382,299 |
|
|
|
145,985,445 |
|
|
|
148,382,299 |
|
|
|
146,644,450 |
|
(1) Includes
share-based compensation |
|
$ |
316 |
|
|
$ |
40 |
|
|
$ |
138 |
|
|
$ |
(2 |
) |
(2) Includes
share-based compensation |
|
$ |
87 |
|
|
$ |
34 |
|
|
$ |
(25 |
) |
|
$ |
14 |
|
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