MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical
company bringing innovative therapies to address unmet needs in
severe burn and wound management, reports financial results for the
three months ended March 31, 2017.
Highlights of the first quarter of 2017
and recent weeks include:
- Total revenues for the first quarter of 2017 were $0.54
million, a 113% increase from $0.25 million in the first quarter of
2016, underscoring the continuous growth of NexoBrid® sales;
- Obtained U.S. Food and Drug Administration (FDA) concurrence
that complete debridement will be the primary endpoint of the U.S.
pivotal program for EscharEx®;
- An independent cost analysis review utilizing NexoBrid in
severe burn management was published in BioMed Research
International and showed that NexoBrid reduced average treatment
costs per patient by more than €5,000 compared with
standard-of-care (SOC);
- Multiple presentations at the American Burn Association (ABA)
Annual Meeting highlighted the positive results achieved by
clinicians using NexoBrid as an enzymatic debridement for
severe burns and EscharEx for debridement of chronic wounds;
- A "Meet the Expert" panel comprised of seven leading burn
specialists from across Europe and the U.S. was convened at the ABA
and shared outcomes from their use of NexoBrid for the
debridement of severe burns and provided insight into the role of
NexoBrid as a potential part of the U.S. SOC;
- Multiple presentations at the Symposium on Advanced Wound Care
(SAWC) Spring 2017 highlighted the positive results achieved by
clinicians using NexoBrid as an enzymatic debridement for
severe burns and EscharEx for debridement of chronic wounds;
and
- Successful completion of a Good Manufacturing Practice (GMP)
audit of the Company's facility in Yavne, Israel by the Israeli
Ministry of Health (IMOH) granting a compliance certificate for
additional three years.
Management Commentary
“We continued to make progress with our
commercial strategy to increase NexoBrid revenue in Europe and
promote NexoBrid globally through distribution agreements while
advancing our clinical programs for NexoBrid and EscharEx in the
U.S.,” stated Gal Cohen, President and Chief Executive Officer of
MediWound. “We are pleased to report revenue growth that more
than doubled compared with the 2016 first quarter and to have an
independent cost analysis published that showed NexoBrid
significantly reduces the average cost of treatment per patient by
more than €5,000 compared with SOC. These data, along with
other independent cost effectiveness studies being conducted,
strongly support our goal to turn NexoBrid into the new SOC in
severe burn treatment. Moreover, published data such as these
highlight our value proposition and support our reimbursement
efforts worldwide.
“We were delighted to report final results from
our Phase 2 EscharEx study in chronic wounds and to have the data
presented at this year’s SAWC. These highly encouraging
results reinforce our belief that EscharEx has the potential to
become a first-in-class topical debridement pharmaceutical
product. There is a great unmet medical need to effectively
debride chronic wounds in a non-surgical and prompt manner, as
debriding is a critical first step for subsequent wound
management. In tandem, we advanced the second cohort of
patients in the study to demonstrate safety over extended periods
of application to enhance convenience and compliance and plan to
report top-line data from this cohort around mid-2017. Based
on the compelling clinical activity and safety data EscharEx
demonstrated, particularly in diabetic foot ulcers (DFUs) and
venous leg ulcers (VLUs), and the magnitude of the commercial
opportunity as affirmed by extensive market research conducted with
more than 200 healthcare professionals, we look forward to
advancing the clinical development of EscharEx.
“Following discussions with the FDA regarding
the pivotal program for EscharEx to treat chronic and hard-to-heal
wounds, we were able to obtain FDA concurrence that complete
debridement will be the primary endpoint of the studies and wound
closure will be measured as a safety outcome to document that
EscharEx has no deleterious effect on wound closure. This design
was used in our recently reported successful second Phase 2 study
as well as in our on-going NexoBrid U.S. Phase 3 study.
Following this meeting with the Agency, we are working to finalize
and initiate our U.S. pivotal program.
“Once again, the ABA was an outstanding venue
for further enhancing the awareness of NexoBrid and increasing the
interest in NexoBrid among US and international burn care
specialists. In addition to more than a dozen poster
presentations highlighting the merits of NexoBrid, the ‘Meet the
Experts’ panel provided great insight into the use of NexoBrid in
Europe, its potential role in the management of burn mass casualty
events and the future integration of NexoBrid as part of the U.S.
SOC for severe burns.
“As a fully integrated company, manufacturing is
a core competency of MediWound and is critical for our R&D and
commercial success. We take great pride in maintaining the highest
quality standards and are particularly pleased that the IMOH is
granting us a compliance certificate for sterile manufacturing for
three years rather than the customary two years for the second
consecutive time. This underscores the viability, quality and
high standards MediWound upholds in the manufacture of our
proteolytic enzyme therapeutics for commercial and clinical use in
compliance with rigorous international standards," concluded Mr.
Cohen.
First Quarter Financial
Results
Revenues for the first quarter of 2017 were
$540,000, more than double revenues of $254,000 for the first
quarter of 2016.
Operating loss for the first quarter of 2017 was
$3.7 million, down 9% from $4.0 in the first quarter of 2016. The
decrease was primarily due to gross profit generated in 2017 of
$0.2 million compared with gross loss of $0.2 in the first quarter
of 2016.
Research and development expenses, net of
participation, for the first quarter of 2017 were $1.8 million, in
line with the Company's budget, compared with $1.0 million for the
first quarter of 2016. The increase was primarily due to an
increase of $0.2 million related to NexoBrid and EscharEx clinical
trials and a decrease of $0.5 million of participation from the
Israeli Innovation Authority, which resulted from revaluation of a
contingent liability in 2016.
Selling, general and administrative expenses in the first
quarter of 2017 decreased $0.8 million to $2.1 million from $2.9
million in the first quarter of 2016.
For the first quarter of 2017, the Company’s net
loss was $4.3 million, or $0.20 per share, compared with a net loss
of $3.8 million, or $0.17 per share, for the first quarter of 2016.
The increase was primarily due to net financial expenses, which
were largely comprised of non-cash revaluation of contingent
liabilities and changes in foreign currency exchange rates.
Adjusted EBITDA, as defined below, for the first
quarter of 2017 was a loss of $3.2 million, compared with a loss of
$3.0 million for the first quarter of 2016.
Balance Sheet Highlights
As of March 31, 2017 the Company had cash and
short-term deposits of $25.2 million, compared with cash and
short-term deposits of $30.0 million as of December 31, 2016.
The Company remained on budget and utilized $4.8 million in cash to
fund operating activities during the first quarter of 2017.
Throughout 2017, the Company will continue to
invest primarily in research and development efforts for NexoBrid,
which is predominantly funded by the Biomedical Advanced Research
and Development Agency (BARDA), and EscharEx for chronic wounds, as
well as in our commercialization efforts. As a result, cash
use for 2017 is expected to remain within our guidance for 2017 in
the range of $15.0 million to $17.0 million.
Conference Call
MediWound management will host a conference call
for investors May 8, 2017 beginning at 8:30 a.m. Eastern time to
discuss these results and answer questions. Shareholders and
other interested parties may participate in the call by dialing
(877) 602-7189 (domestic) or (678) 894-3057 (international) and
entering passcode 4551719. The call also will be broadcast
live on the Internet on the Company’s website at
www.mediwound.com.
A replay of the call will be accessible two
hours after its completion through May 14, 2017 by dialing (855)
859-2056 (domestic and international) or and entering passcode
4551719. The call will also be archived on the Company website for
90 days at www.mediwound.com.
Non-IFRS Financial Measures
To supplement consolidated financial statements
prepared and presented in accordance with IFRS, the Company has
provided a supplementary non-IFRS measure to consider in evaluating
the Company’s performance. Management uses Adjusted EBITDA, which
it defines as earnings before interest, taxes, depreciation and
amortization, impairment, one-time expenses, restructuring and
stock-based compensation expenses.
Although Adjusted EBITDA is not a measure of
performance or liquidity calculated in accordance with IFRS, we
believe the non-IFRS financial measures we present provide
meaningful supplemental information regarding our operating results
primarily because they exclude certain non-cash charges or items
that we do not believe are reflective of our ongoing operating
results when budgeting, planning and forecasting and determining
compensation, and when assessing the performance of our business
with our senior management.
However, investors should not consider these
measures in isolation or as substitutes for operating income, cash
flows from operating activities or any other measure for
determining the Company’s operating performance or liquidity that
is calculated in accordance with IFRS. In addition, because
Adjusted EBITDA is not calculated in accordance with IFRS, it may
not necessarily be comparable to similarly titled measures employed
by other companies. The non-IFRS measures included in this press
release have been reconciled to the IFRS results in the tables
below.
About MediWound Ltd.
MediWound is a fully-integrated
biopharmaceutical company focused on developing, manufacturing and
commercializing novel therapeutics based on its patented
proteolytic enzyme technology to address unmet needs in the fields
of severe burns, chronic and other hard-to-heal wounds. MediWound’s
first innovative biopharmaceutical product, NexoBrid®, received
marketing authorization from the European Medicines Agency as well
as the Israeli and Argentinian Ministries of Health, for removal of
dead or damaged tissue, known as eschar, in adults with deep
partial and full-thickness thermal burns and was launched in Europe
and Israel, with plans for a launch in Argentina.
NexoBrid® represents a new paradigm in burn care management,
and clinical trials have demonstrated, with statistical
significance, its ability to non-surgically and rapidly remove the
eschar earlier and, without harming viable tissues.
MediWound's second innovative product, EscharEx®
is a topical biological drug being developed for debridement of
chronic and other hard-to-heal wounds and is complementary to the
large number of existing wound healing products, which require a
clean wound bed in order to heal the wound. EscharEx® contains the
same proteolytic enzyme technology as NexoBrid®, and benefits from
the wealth of existing development data on NexoBrid®. In two
Phase 2 studies, EscharEx® has demonstrated safety and efficacy in
the debridement of chronic and other hard-to-heal wounds, within a
few daily applications. For more information, please visit
www.mediwound.com.
Cautionary Note Regarding
Forward-Looking Statements
This release includes forward-looking statements
within the meaning of Section 27A of the U.S. Securities Act of
1933, as amended, Section 21E of the US Securities Exchange Act of
1934, as amended, and the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995. Forward-looking
statements are statements that are not historical facts, such as
statements regarding assumptions and results related to the
regulatory authorizations and launch dates. In some cases, you
can identify forward-looking statements by terminology such as
“believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,”
“should,” “plan,” “expect,” “predict,” “potential,” or the negative
of these terms or other similar expressions. Forward-looking
statements are based on MediWound’s current knowledge and its
present beliefs and expectations regarding possible future events
and are subject to risks, uncertainties and assumptions. Actual
results and the timing of events could differ materially from those
anticipated in these forward-looking statements as a result of
several factors. In particular, you should consider the risks
discussed under the heading “Risk Factors” in our annual report on
Form 20-F for the year ended December 31, 2016 and information
contained in other documents filed with or furnished to the
Securities and Exchange Commission. You should not rely upon
forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that
future results, levels of activity, performance and events and
circumstances reflected in the forward-looking statements will be
achieved or will occur. The forward-looking statements made herein
speak only as of the date of this announcement and MediWound
undertakes no obligation to update publicly such forward-looking
statements to reflect subsequent events or circumstances, except as
otherwise required by law.
Contacts: |
|
Anne Marie Fields |
Sharon Malka |
|
Senior Vice
President |
Chief Financial and
Operations Officer |
|
LHA |
MediWound |
|
212-838-3777 |
ir@mediwound.co.il |
|
afields@lhai.com |
Tables to Follow
CONDENSED CONSOLIDATED BALANCE
SHEETS |
U.S. dollars in thousands |
|
|
|
March 31, |
|
December 31, |
|
|
2017 |
|
2016 |
|
2016 |
|
|
Unaudited |
|
|
Cash, cash equivalents
and short term deposits |
|
25,229 |
|
41,591 |
|
30,029 |
Accounts and other
receivable |
|
3,276 |
|
3,283 |
|
2,739 |
Inventories |
|
991 |
|
1,534 |
|
844 |
|
|
29,496 |
|
46,408 |
|
33,612 |
Long term deposits |
|
44 |
|
135 |
|
103 |
Property, plant and
equipment, net |
|
1,357 |
|
1,267 |
|
1,276 |
Intangible assets,
net |
|
729 |
|
874 |
|
773 |
|
|
2,130 |
|
2,276 |
|
2,152 |
|
|
31,626 |
|
48,684 |
|
35,764 |
Trade payables and
accrued expenses |
|
2,732 |
|
2,666 |
|
3,320 |
Other payables |
|
2,355 |
|
2,293 |
|
2,060 |
|
|
5,087 |
|
4,959 |
|
5,380 |
Deferred
revenues |
|
995 |
|
- |
|
1,023 |
Liabilities in respect
of Israeli Innovation Authority grants net of current
maturities |
|
6,997 |
|
7,019 |
|
6,839 |
Contingent
consideration for the purchase of shares net of current
maturities |
|
14,540 |
|
16,041 |
|
14,533 |
Severance pay
liability, net |
|
226 |
|
101 |
|
219 |
|
|
22,758 |
|
23,161 |
|
22,614 |
|
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY |
|
3,781 |
|
20,564 |
|
7,770 |
|
|
31,626 |
|
48,684 |
|
35,764 |
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR
LOSS AND OTHER COMPREHENSIVE LOSS
(UNAUDITED) |
U.S. dollars in thousands (except share
and loss per share) |
|
|
Three months ended |
March 31, |
|
2017 |
|
2016 |
|
|
|
|
Revenues |
540 |
|
|
254 |
|
Cost
of revenues |
340 |
|
|
404 |
|
Gross profit (loss) |
200 |
|
|
(150 |
) |
Operating expenses: |
|
|
|
Research and development, gross |
3,441 |
|
|
3,230 |
|
Participation by BARDA & IIA |
(1,670 |
) |
|
(2,237 |
) |
Research and development, net of participations |
1,771 |
|
|
993 |
|
Selling, general & administrative |
2,092 |
|
|
2,861 |
|
Operating loss |
(3,663 |
) |
|
(4,004 |
) |
Financial income (expenses), net |
(651 |
) |
|
230 |
|
Loss for the period |
(4,314 |
) |
|
(3,774 |
) |
|
|
|
|
Foreign currency translation adjustments |
(3 |
) |
|
(6 |
) |
Total comprehensive loss |
(4,317 |
) |
|
(3,780 |
) |
|
|
|
|
Net loss per share |
(0.20 |
) |
|
(0.17 |
) |
|
|
|
|
|
|
Weighted average number of ordinary shares used in the
computation of basic and diluted loss per share: |
21,930 |
|
|
21,850 |
|
RECONCILIATION OF NET LOSS TO ADJUSTED EBITDA
(UNAUDITED) |
U.S. dollars in thousands |
|
March 31, |
|
2017 |
|
2016 |
Loss
for the period |
(4,314 |
) |
|
(3,774 |
) |
Adjustments: |
|
|
|
Financial (expenses) income, net |
(651 |
) |
|
230 |
|
Depreciation and amortization |
(156 |
) |
|
(123 |
) |
Share-based compensation expenses |
(328 |
) |
|
(874 |
) |
Total
adjustments |
(1,135 |
) |
|
(767 |
) |
Adjusted EBITDA |
(3,179 |
) |
|
(3,007 |
) |
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