SteadyMed Provides Corporate Update and Reports First Quarter 2018 Financial Results
15 Mai 2018 - 2:00PM
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 first quarter ended March 31, 2018.
Summary Corporate Update:
- On April 29, 2018, SteadyMed and United Therapeutics
Corporation (NASDAQ:UTHR) entered into a definitive merger
agreement under which United Therapeutics will acquire SteadyMed
for $4.46 per share in cash at closing and an additional $2.63 per
share in cash upon the achievement of a milestone related to the
commercialization of Trevyent®. The transaction, including the $75
million in contingent consideration, is valued at $216 million.
- The validation and verification work on our lead drug product
candidate Trevyent®,, which is in development for the treatment of
Pulmonary Arterial Hypertension (PAH), is ongoing; the Trevyent NDA
remains on track for resubmission to the FDA before the end of
2018.
- In March 2018, SteadyMed received a notice of allowance for
U.S. Patent Application No. 14/456,416. The patent provides broad
coverage for our PatchPump Drug Delivery Device, including its
ECell displacement generating battery and prefilled drug
reservoir.
“We
are pleased that our progress towards NDA re-submission for
Trevyent is on track for later this year,” said Jonathan Rigby,
President and Chief Executive Officer of SteadyMed. “In addition,
we believe that the proposed merger with United Therapeutics will
help us realize our commitment to bring Trevyent to market to
improve the lives of patients with PAH.”
First Quarter 2018 Financial Results
Compared to First Quarter 2017 Financial Results
SteadyMed recorded no licensing revenues in the
first quarter of 2018, compared to revenues of $315,000 in the
first quarter of 2017. In the fourth quarter 2017, SteadyMed
completed the recognition of revenue associated with the $3 million
upfront payment received from Cardiome in 2015.
For the first quarter ended March 31, 2018,
SteadyMed reported a net loss of $10.4 million, or $0.39 per share,
compared to a net loss of $18.6 million, or $0.92 per share for the
first quarter ended March 31, 2017. The current quarter's
calculation of loss per share is based on 26,572,719
weighted-average shares outstanding compared to 20,139,826 shares
outstanding in the prior-year period.
Total operating expenses for the first quarter
ended March 31, 2018 were $6.1 million, compared to $6.0 million
for the quarter ended March 31, 2017. The increase in operating
expenses was primarily attributable to an increase in general and
administrative (G&A) expenses offset by decreases in research
and development (R&D) expenses and sales and marketing
(S&M) expenses.
R&D expenses for the first quarter of 2018
were $3.9 million, compared to $4.1 million for the first quarter
of 2017. The decrease in R&D expenses was primarily due to a
decrease in use of sub-contractor services, and materials for
Trevyent and our other development programs.
G&A expenses for the first quarter of 2018
were $2.0 million, compared to $1.3 million for the first quarter
of 2017. The increase in G&A expenses was primarily due to an
increase in legal expenses related to the recently-announced merger
agreement with United Therapeutics.
S&M expenses for the first quarter of 2018
were $0.1 million compared to $0.6 million for the first quarter of
2017. The decrease in S&M was primarily due to decreases in
consulting fees and salary expenses associated with the scaling
back of the pre-commercialization plan for Trevyent in response to
the refusal to file letter from the FDA for the Trevyent NDA.
In the first quarter of 2018, the Company
recorded $4.2 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 $12.7 million
in financial expense for the first quarter of 2017 primarily as a
result of the change in the fair value of the warrants issued in
the August 2016 private placement.
As of March 31, 2018, SteadyMed had cash and
cash equivalents of $26.6 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, Canada and the Middle
East. 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 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 Quarterly
Report on Form 10-Q filed on May 15, 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) |
|
|
|
|
|
Three months endedMarch
31, |
|
|
2018 |
|
2017 |
|
|
Unaudited |
|
|
|
|
|
Licensing Revenues |
|
$ |
0 |
|
$ |
315 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
3,921 |
|
$ |
4,101 |
Sales and marketing |
|
|
136 |
|
|
588 |
General and administrative |
|
|
2,023 |
|
|
1,316 |
|
|
|
|
|
Total
operating expenses |
|
|
6,080 |
|
|
6,005 |
|
|
|
|
|
Total
operating loss |
|
|
6,080 |
|
|
5,690 |
|
|
|
|
|
Financial expense, net |
|
|
4,159 |
|
|
12,721 |
|
|
|
|
|
Loss
before taxes on income |
|
|
10,239 |
|
|
18,411 |
|
|
|
|
|
Taxes
on income |
|
|
116 |
|
|
148 |
|
|
|
|
|
Net
loss |
|
$ |
10,355 |
|
$ |
18,559 |
|
|
|
|
|
Net
loss per share: |
|
|
|
|
Basic
and diluted net loss per Ordinary Share |
|
$ |
0.39 |
|
$ |
0.92 |
|
|
|
|
|
Weighted average number of Ordinary Shares used in computing
basic and diluted net loss per share |
|
|
26,572,719 |
|
|
20,139,826 |
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED BALANCE SHEETS |
U.S. dollars in thousands |
|
|
|
|
|
March 31,2018 |
|
December 31,2017 |
|
Unaudited |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
Cash
and cash equivalents |
$ |
26,639 |
|
$ |
32,453 |
|
|
|
|
Property and equipment, net |
|
5,798 |
|
|
5,307 |
|
|
|
|
Other
assets |
|
728 |
|
|
731 |
|
|
|
|
Total
assets |
$ |
33,165 |
|
$ |
38,491 |
|
|
|
|
|
Liabilities and shareholders' equity
(deficit): |
|
|
|
|
|
|
|
|
|
Current liabilities |
|
3,190 |
|
|
2,756 |
|
|
|
|
|
Liability related to warrants |
|
15,544 |
|
|
11,343 |
|
|
|
|
|
Other
non-current liabilities |
|
596 |
|
|
581 |
|
|
|
|
|
Shareholders' equity |
|
13,835 |
|
|
23,811 |
|
|
|
|
|
Total
liabilities and shareholders' equity |
$ |
33,165 |
|
$ |
38,491 |
|
|
|
|
|
|
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