SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company
focused on the development of drug product candidates to treat
orphan and high-value diseases with unmet parenteral delivery
needs, today provided a corporate update and announced its
financial results for the fourth quarter and full year ended
December 31, 2017.
Summary Q4 2017 and Recent Corporate
Update:
- In November 2017, SteadyMed held an in-person Type A meeting
with the Food and Drug Administration (FDA) regarding the necessary
steps leading to a re-submission of its New Drug Application (NDA)
for its lead drug candidate Trevyent, that is in development
for the treatment of Pulmonary Arterial Hypertension (PAH). The
Company believes the meeting was collaborative and constructive and
has agreed to a path forward with FDA that it expects will allow
for the resubmission and acceptance of its Trevyent NDA before the
end of 2018.
- In November 2017, the U.S. Court of Appeals affirmed the ruling
by the Patent Trial and Appeal Board of the USPTO invalidating U.S.
Patent No. 8,497,393 (the '393 patent) owned by United
Therapeutics. The ‘393 patent related to a product made by a
process to purify prostacyclin derivatives, such as treprostinil,
the active pharmaceutical ingredient used in United Therapeutics'
Remodulin® and SteadyMed's lead drug candidate Trevyent.
- In October, 2017, SteadyMed received a notice of allowance for
its European patent application No. 13720085.3 relating to enhanced
reduction of infusion-site pain for drug delivery
devices.
- In March, 2018, the SteadyMed received a notice of allowance
for U.S. Patent Application No. 14/456,416. The patent covers our
PatchPump Drug Delivery Device broadly, including its ECell
displacement generating battery and prefilled drug reservoir.
“I am pleased that we ended 2017 with clarity
from the FDA on the steps necessary for re-submission of our
Trevyent NDA. The pre-design verification (pre-DV) testing of our
Trevyent product is progressing to plan and we remain on track to
re-submit our NDA and, subject to review by FDA, have it accepted
for filing by the end of 2018,” said Jonathan Rigby, President and
Chief Executive Officer of SteadyMed. “In addition, we ended 2017
with a cash balance of $32.5 million, bolstered by the proceeds of
our successful April 2017 Private Placement and a warrant exercise
by a large institutional shareholder. Overall, we believe that we
are well positioned to execute on our primary strategic and
operational objectives in 2018, and look forward to sharing updates
of our progress with our shareholders.”
Fourth Quarter 2017 Financial Results
Compared to Fourth Quarter 2016 Financial Results
SteadyMed recorded licensing revenues of
$109,000 in the fourth quarter of 2017, compared to revenues of
$320,000 in the fourth quarter of 2016. The recorded revenues were
attributable to the recognition of revenue from the $3 million
upfront payment received from Cardiome during 2015, in connection
with the license of rights to Trevyent in Europe, the Middle East
and Canada. During the fourth quarter of 2017, SteadyMed completed
its obligations to provide services associated with the $3 million
upfront payment and completed the recognition of revenue associated
with the payment.
For the fourth quarter ended December 31, 2017,
SteadyMed reported a net loss of $5.9 million, or $0.22 per share,
compared to a net loss of $2.4 million, or $0.12 per share for the
fourth quarter ended December 31, 2016. The loss for the fourth
quarter of 2016 would have been greater than the current period
loss but for financial income of $4.1 million from the revaluation
of warrants. The current quarter's calculation of loss per share is
based on 26,599,494 weighted-average shares outstanding, versus
20,139,826 outstanding shares in the prior-year period.
Total operating expenses for the fourth quarter
ended December 31, 2017 were $5.0 million, compared to $6.7 million
for the quarter ended December 31, 2016. Research and development
(R&D), general and administrative (G&A), and sales and
marketing (S&M) expenses decreased during the quarter primarily
resulting from cash conservation measures instituted by the Company
in response to receiving the Refuse to File letter from the FDA at
the end of August.
R&D expenses for the fourth quarter of 2017
were $3.2 million, compared to $4.6 million for the fourth quarter
of 2016. The decrease in R&D expenses was primarily due to a
decreased use of sub-contractor services and materials for Trevyent
and our other development programs offset by an increase in
depreciation and impairment of property and equipment.
G&A expenses for the fourth quarter of 2017
were $1.3 million, compared to $1.5 million for the fourth quarter
of 2016. The decrease in G&A expenses was primarily due to a
decrease in legal and intellectual property expenses partially
offset by an increase in personnel related costs.
S&M expenses for the fourth quarter of 2017
were $0.4 million compared to $0.7 million for the fourth quarter
of 2016. The decrease in S&M was primarily due to a decrease in
consulting fees related to pre- commercialization of Trevyent
offset by an increase in personnel related costs.
In the fourth quarter of 2017, the Company
recorded $1.0 million in financial expense primarily as a result of
the change in the fair value of the warrants issued in the April
2017 and August 2016 private placements compared to $4.0 million in
financial income for the fourth quarter of 2016 primarily as a
result of the change in the fair value of the warrants issued in
the August 2016 private placement.
Year Ended December 31, 2017 Financial
Results Compared to Year Ended December 31, 2016 Financial
Results
For the year ended December 31, 2017, SteadyMed
recorded licensing revenues of $1,065,000, same as the year ended
December 31, 2016. The recorded revenues were attributable to the
recognition of revenue from the $3 million upfront payment received
from Cardiome during 2015, as discussed above.
For the year ended December 31, 2017, SteadyMed
reported a net loss of $23.2 million, or $0.95 per share, compared
to a net loss of $25.9 million, or $1.59 per share for the year
ended December 31, 2016. The current year’s calculation of loss per
share is based on 24,421,288 weighted-average shares outstanding,
versus 16,253,975 outstanding shares in the prior-year period.
Total operating expenses for the year ended
December 31, 2017 were $21.5 million, compared to $28.5 million for
the year ended December 31, 2016. While all operating expense
categories decreased in the current year period, R&D led the
decrease resulting from activities and projects in the department
winding down as the Company prepared and filed the Trevyent NDA
with the FDA in June.
R&D expenses for the year ended December 31,
2017 were $14.6 million, compared to $20.9 million for the year
ended December 31, 2016. The decrease in R&D expenses was
primarily due to decreases in use of sub-contractor services and
materials for Trevyent and travel offset by increases in personnel
related costs and depreciation and impairment of property and
equipment.
G&A expenses for the year ended December 31,
2017 were $5.2 million, compared to $5.6 million for the year ended
December 31, 2016. The decrease in G&A expenses was primarily
due to decreases in legal and intellectual property expenses and
other G&A consultants.
S&M expenses for the year ended December 31,
2017 were $1.7 million compared to $1.9 million for the year ended
December 31, 2016. The decrease in S&M was primarily due to a
decrease in consulting fees related to pre-commercialization of
Trevyent offset by an increase in personnel related costs.
For the year ended December 31, 2017, the
Company recorded $2.8 million in financial expense primarily as a
result of the change in the fair value of the warrants issued in
the April 2017 and August 2016 private placements and issuance
costs allocated to those warrants. For the year ended December 31,
2016, the Company recorded $1.9 million in financial income
primarily as a result of the change in the fair value of the
warrants issued in the August 2016 private placement net of
issuance costs allocated to those warrants.
As of December 31, 2017, SteadyMed had cash and
cash equivalents of $32.5 million.
About SteadyMed
SteadyMed Ltd. is a specialty pharmaceutical
company focused on the development of drug products to treat orphan
and high value diseases with unmet parenteral delivery needs. The
company's lead drug product candidate is Trevyent®, a development
stage drug product that combines SteadyMed's PatchPump® technology
with treprostinil, a vasodilatory prostacyclin analogue to treat
pulmonary arterial hypertension (PAH). SteadyMed intends to
commercialize Trevyent in the U.S. and has signed an exclusive
license and supply agreement with Cardiome Pharma Corp. for the
commercialization of Trevyent in Europe and the Middle East. In
March 2018, Cardiome sublicensed its rights to sell Trevyent in
Canada to Cipher Pharmaceuticals. SteadyMed has offices in San
Ramon, California and Rehovot, Israel. For additional information
about SteadyMed please visit www.steadymed.com.
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include, among
others, statements about the company's ability to advance its
development-stage product candidates, including Trevyent,
statements about the potential benefits of our development-stage
product candidates and our PatchPump technology, statements about
the potential outcome of Inter Partes Review of U.S. Patent No.
8,497,393, statements about the potential benefits of orphan drug
designation, and statements about our ability to obtain and
maintain regulatory approval of our development-stage product
candidates. Forward-looking statements reflect the company's
current views with respect to certain current and future events and
are subject to various risks, uncertainties and assumptions that
could cause actual results to differ materially. Risks and
uncertainties include, but are not limited to, the risk that
Trevyent does not demonstrate clinical superiority to existing
parenteral treprostinil products, that Trevyent is not approved for
commercialization by the FDA, that Trevyent is not granted orphan
drug exclusivity, and the risk that drug development involves a
lengthy and expensive process with uncertain outcome. The risks,
uncertainties and assumptions referred to above are discussed in
detail in our reports filed with the Securities and Exchange
Commission, including our Annual Report on Form 10-K filed on March
30, 2018. The company does not undertake to publicly update or
revise any forward-looking statements to reflect events or
circumstances that may arise after the date hereof except as may be
required by law.
Contacts:
Marylyn RigbySenior Director, Investor Relations
and Marketing925-272-4999mrigby@steadymed.com
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS |
|
|
|
U.S. dollars in
thousands (except share data) |
|
|
|
|
|
|
|
|
|
Year endedDeccember 31, |
|
|
|
2017 |
|
|
|
2016 |
|
Licensing Revenues |
$ |
1,065 |
|
|
$ |
1,065 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
$ |
14,605 |
|
|
$ |
20,902 |
|
Marketing |
|
1,741 |
|
|
|
1,921 |
|
General
and administrative |
|
5,154 |
|
|
|
5,640 |
|
Total operating
expenses |
|
21,500 |
|
|
|
28,463 |
|
Total operating
loss |
|
20,435 |
|
|
|
27,398 |
|
Financial expense
(income), net |
|
2,764 |
|
|
|
(1,901 |
) |
Loss before taxes on
income |
|
23,199 |
|
|
|
25,497 |
|
Taxes on income |
|
6 |
|
|
|
372 |
|
Net loss |
$ |
23,205 |
|
|
$ |
25,869 |
|
Net loss per share: |
|
|
|
Basic and diluted net
loss per Ordinary Share |
$ |
(0.95 |
) |
|
$ |
(1.59 |
) |
Weighted average number of Ordinary Shares
used in computing basic and diluted net loss per share |
|
24,421,288 |
|
|
|
16,253,975 |
|
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
U.S. dollars in
thousands |
|
|
December 31, |
|
2017 |
2016 |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
Cash and
cash equivalents |
$ |
32,453 |
|
$ |
23,215 |
Property
and equipment, net |
|
5,307 |
|
|
4,549 |
Other
assets |
|
731 |
|
|
394 |
Total
assets |
$ |
38,491 |
|
$ |
28,158 |
Liabilities and
shareholders' equity (deficit): |
|
|
|
|
|
Current
liabilities |
|
2,756 |
|
|
5,291 |
Deferred
revenues |
|
-- |
|
|
1,066 |
Liability
related to warrants |
|
11,343 |
|
|
7,078 |
Other
non-current liabilities |
|
581 |
|
|
412 |
Shareholders' equity (deficit) |
|
23,811 |
|
|
14,311 |
Total
liabilities and shareholders' equity (deficit) |
$ |
38,491 |
|
$ |
28,158 |
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