SteadyMed Provides Corporate Update and Reports Second Quarter 2018 Financial Results
August 14 2018 - 6:00AM
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 second quarter ended June 30, 2018.
Summary Corporate Update:
- On July 31, 2018, SteadyMed announced that its
shareholders voted to approve the previously announced acquisition
of the company by United Therapeutics Corporation (Nasdaq:
UTHR) at an extraordinary general meeting of shareholders held
on July 30, 2018. The merger is expected to close in the third
quarter, 2018.
- On July 20, 2018, SteadyMed and United Therapeutics announced
the termination of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 relating to United
Therapeutics' previously announced acquisition
of SteadyMed.
- On April 30, 2018, SteadyMed announced the signing of 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®, which is in development for the treatment of Pulmonary
Arterial Hypertension (PAH). The transaction, including
the $75 million in contingent consideration, is valued
at $216 million.
“We are delighted about the merger prospect with
United Therapeutics and believe it will help us realize our
commitment to bring Trevyent to market to improve the lives of
patients with PAH,” said Jonathan M.N. Rigby President & CEO.
“In addition, the validation and verification work on our lead drug
product candidate Trevyent, is ongoing and the Trevyent NDA
remains on track for resubmission to the FDA before the
end of 2018,”
Second Quarter 2018 Financial Results
Compared to Second Quarter 2017 Financial Results
SteadyMed did not record any revenues in the
second quarter of 2018, as it had previously recognized all of the
revenue associated with the $3 million upfront payment received in
2015 from Cardiome. In the second quarter of 2017, the Company
recognized revenues of $319,000 from the Cardiome payment.
For the second quarter ended June 30, 2018,
SteadyMed reported a net loss of $10 million, or $0.38 per share,
compared to a net loss of $8.1 million, or $0.33 per share for the
second quarter ended June 30, 2017. The current quarter calculation
of loss per share is based on 26,596,407 weighted-average shares
outstanding versus 24,335,774 shares outstanding in the prior-year
period.
Total operating expenses for the second quarter
ended June 30, 2018 were $7.3 million, compared to $5.1 million for
the second quarter ended June 30, 2017. The increase in operating
expenses was primarily attributable to increases in general and
administrative (G&A) and research and development (R&D)
expenses offset by a decrease in sales and marketing (S&M)
expenses.
R&D expenses for the second quarter of 2018
were $4.0 million, compared to $3.5 million for the second quarter
of 2017. The increase in R&D expenses was primarily due to an
increase in sub-contractors and materials costs associated with the
preparations for the resubmission of the Trevyent NDA.
G&A expenses for the second quarter of 2018
were $3.2 million, compared to $1.2 million for the second quarter
of 2017. The increase in G&A expenses was primarily due to an
increase in legal fees, consulting and other expenses related to
the recently-announced Merger Agreement with United
Therapeutics.
S&M expenses for the second quarter of 2018
were $0.1 million compared to $0.4 million for the second quarter
of 2017. The decrease in S&M was primarily due to a decrease in
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.
Financial expenses, net for the second quarter
of 2018 was $2.8 million compared to $3.2 million for the second
quarter of 2017. The decrease was primarily due to $0.4 million in
warrant issuance expenses incurred in Q2 2017 related to the April
2017 private placement.
As of June 30, 2018, SteadyMed had cash and cash
equivalents of $21.1 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 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 August 14, 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 ended June 30, |
|
Six months ended June 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
Unaudited |
|
Unaudited |
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
- |
|
$ |
319 |
|
$ |
- |
|
$ |
634 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
3,981 |
|
$ |
3,530 |
|
$ |
7,902 |
|
$ |
7,631 |
Sales and
marketing |
|
|
130 |
|
|
363 |
|
|
266 |
|
|
951 |
General and
administrative |
|
|
3,179 |
|
|
1,226 |
|
|
5,202 |
|
|
2,542 |
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
7,290 |
|
|
5,119 |
|
|
13,370 |
|
|
11,124 |
|
|
|
|
|
|
|
|
|
Total operating
loss |
|
|
7,290 |
|
|
4,800 |
|
|
13,370 |
|
|
10,490 |
|
|
|
|
|
|
|
|
|
Financial expenses,
net |
|
|
2,755 |
|
|
3,207 |
|
|
6,914 |
|
|
15,929 |
|
|
|
|
|
|
|
|
|
Loss before taxes on
income |
|
|
10,045 |
|
|
8,007 |
|
|
20,284 |
|
|
26,419 |
|
|
|
|
|
|
|
|
|
Taxes on income |
|
|
25 |
|
|
139 |
|
|
141 |
|
|
287 |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
10,070 |
|
$ |
8,146 |
|
$ |
20,425 |
|
$ |
26,706 |
|
|
|
|
|
|
|
|
|
Net loss per
share: |
|
|
|
|
|
|
|
|
Basic and diluted net
loss per Ordinary Share |
|
$ |
0.38 |
|
$ |
0.33 |
|
$ |
0.77 |
|
$ |
1.20 |
Weighted-average number
of Ordinary Shares used to compute basic and diluted net loss
per share |
|
|
26,596,407 |
|
|
24,335,774 |
|
|
26,584,628 |
|
|
22,249,391 |
CONSOLIDATED BALANCE SHEETS |
|
U.S. dollars in thousands |
|
|
|
|
June 30,2018 |
|
December 31,2017 |
|
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
21,129 |
|
$ |
32,453 |
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
6,134 |
|
|
5,307 |
|
|
|
|
|
|
|
Other
assets |
|
|
567 |
|
|
731 |
|
|
|
|
|
|
|
Total
assets |
|
$ |
27,830 |
|
$ |
38,491 |
|
|
|
|
|
|
|
|
|
Liabilities and shareholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
4,475 |
|
|
2,756 |
|
|
|
|
|
|
|
|
|
Liability
related to warrants |
|
|
18,436 |
|
|
11,343 |
|
|
|
|
|
|
|
|
|
Other
non-current liabilities |
|
|
601 |
|
|
581 |
|
|
|
|
|
|
|
|
|
Shareholders' equity |
|
|
4,318 |
|
|
23,811 |
|
|
|
|
|
|
|
|
|
Total
liabilities and shareholders' equity |
|
$ |
27,830 |
|
$ |
38,491 |
|
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