SteadyMed Reports Second Quarter 2017 Financial Results and Provides Corporate Update
August 11 2017 - 8:30AM
Submitted New Drug Application for
Trevyent for the Treatment of Pulmonary Arterial
Hypertension
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 reported financial
results for the second quarter ended June 30, 2017.
Second Quarter 2017 and Recent Corporate
Highlights Include:
- In June, SteadyMed submitted its New Drug Application (NDA) to
the Food and Drug Administration (FDA) for Trevyent® for the
treatment of Pulmonary Arterial Hypertension (PAH). Designed to
address the limitations of existing PAH therapies, Trevyent
combines SteadyMed’s preservative-free, parenteral treprostinil
formulation with the Company’s proprietary PatchPump, in a sterile,
pre-filled, pre-programmed, single use disposable infusion system
capable of delivering treprostinil subcutaneously or intravenously.
- In April, SteadyMed was successful in raising additional
capital with $28.1 million in net proceeds in a private placement
led by institutional healthcare investors Adage Capital, OrbiMed,
Deerfield Management and Kingdon Capital Management. This
additional capital is expected to fund pre- and post- launch
commercial activities, distribution network establishment and
manufacture of commercial Trevyent inventory aimed at a mid-2018
commercial launch in the U.S., subject to NDA approval, as well as
working capital and general corporate purposes.
- In May, SteadyMed raised an additional $4.8 million in capital
when a large institutional shareholder exercised its warrants to
purchase additional ordinary shares of the Company.
- In July, SteadyMed appointed Jeff Myers, M.D., Ph.D. as Vice
President, Medical Affairs. Dr. Myers, who joined the Company from
Gilead Sciences, brings significant experience in the
cardio-pulmonary space, including direct experience with PAH
products. At SteadyMed, he will be responsible for scientific and
medical affairs in support of Trevyent.
“SteadyMed has had a very successful year to
date, culminating in the June 30, 2017 submission of an NDA for our
lead drug candidate, Trevyent. PAH is a serious, life threatening
disease, and currently, the administration of high dose
prostacyclins to help these patients has some serious challenges.
Trevyent has been developed with the aim of addressing these
challenges,” said Jonathan Rigby, President and Chief Executive
Officer of SteadyMed. “We completed the second quarter with a
strong cash position of $43.5 million. We believe this provides the
necessary foundation to execute on our next major milestones for
the Company through the launch of Trevyent in the U.S., which is
anticipated in mid-2018, subject to FDA approval.”
Second Quarter 2017 Financial Results
Compared to Second Quarter 2016 Financial Results
SteadyMed recorded licensing revenues of $319
thousand in the second quarter of 2017, compared to $94 thousand in
the second quarter of 2016. The increase in recorded revenues was
attributable to the adjustment to the estimated performance
obligations period in the second quarter of 2016.
For the second quarter of 2017, SteadyMed
reported a net loss of $8.1 million, or $0.33 per share, compared
to a net loss of $7.2 million, or $0.53 per share for the second
quarter of 2016. The current quarter's calculation of loss per
share is based on 24,335,774 weighted-average shares outstanding,
versus 13,585,810 outstanding shares in the prior-year period.
Total operating expenses for the second quarter
of 2017 were $5.1 million, compared to $7.2 million for the second
quarter of 2016. The decrease in total operating expenses was
primarily attributable to a decrease in Research and Development
(R&D) expenses of $1.8 million and a decrease in Sales and
Marketing (S&M) expenses of $0.2 million.
R&D expenses for the second quarter of 2017
were $3.5 million, compared to $5.3 million for the second quarter
of 2016. The decrease in R&D expenses was primarily due to a
decrease of $1.8 million in subcontractors and materials costs.
S&M expenses for the second quarter of 2017
were $0.4 million, compared to $0.6 million for the second quarter
of 2016. The decrease was primarily due to a decrease of $0.5
million in consulting fees and costs related to the
pre-commercialization plan for Trevyent, offset by a $0.2 million
increase in salary expenses mainly due to increase in
headcount.
General and administrative (G&A) expenses
for the second quarter of 2017 and 2016 were $1.2 million.
Financial expenses, net, amounted to $3.2
million during the second quarter of 2017, were mainly due to an
increase in the fair value of warrants to purchase Ordinary Shares
in the amount $2.8 million and $0.4 million of warrant issuance
costs. The fair value of the warrants increased as a result of the
increase in the trading price of the Ordinary Shares of the Company
on Nasdaq during the second quarter of 2017. Interest income of
$0.07 million was offset by interest expense on bank debt, bank
fees and foreign currency translation adjustments. Financial
income, net, amounted to $0.014 million during the second quarter
of 2016.
As of June 30, 2017, SteadyMed had cash and cash
equivalents of $43.5 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 pre-filled, sterile,
single use, disposable, PatchPump® infusion system, 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.
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 or approval is delayed by patent
litigation, that Trevyent is not granted orphan drug exclusivity,
the risk that drug development involves a lengthy and expensive
process with uncertain outcome, that the company will not satisfy
the milestone and other closing conditions to call the second
tranche of its July 2016 private placement, that the company will
continue to need additional funding, and that the company may be
unable to raise capital when needed, which would force the company
to delay, reduce or eliminate its product candidate development
programs and potentially cease operations. There can be no
assurance that the company will be able to complete the offering on
the terms described herein or in a timely manner, if at all. 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 11, 2017. 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.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS |
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U.S. dollars in
thousands (except share data) |
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Three months ended
June 30, |
|
Six months ended
June 30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
Unaudited |
|
Unaudited |
Revenues |
|
$ |
319 |
|
|
$ |
94 |
|
|
$ |
634 |
|
|
$ |
469 |
|
|
|
|
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|
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|
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|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
3,530 |
|
|
$ |
5,304 |
|
|
$ |
7,631 |
|
|
$ |
10,268 |
|
Sales and
marketing |
|
|
363 |
|
|
|
611 |
|
|
|
951 |
|
|
|
823 |
|
General
and administrative |
|
|
1,226 |
|
|
|
1,246 |
|
|
|
2,542 |
|
|
|
2,680 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
5,119 |
|
|
|
7,161 |
|
|
|
11,124 |
|
|
|
13,771 |
|
|
|
|
|
|
|
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|
|
|
|
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|
Total operating
loss |
|
|
4,800 |
|
|
|
7,067 |
|
|
|
10,490 |
|
|
|
13,302 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Financial expenses
(income), net |
|
|
3,207 |
|
|
|
(14 |
) |
|
|
15,929 |
|
|
|
(83 |
) |
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|
|
|
|
|
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|
|
|
|
|
|
Loss before taxes on
income |
|
|
8,007 |
|
|
|
7,053 |
|
|
|
26,419 |
|
|
|
13,219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on income |
|
|
139 |
|
|
|
102 |
|
|
|
287 |
|
|
|
211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
8,146 |
|
|
$ |
7,155 |
|
|
$ |
26,706 |
|
|
$ |
13,430 |
|
Net loss per
share: |
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Basic and diluted net
loss per Ordinary Share |
|
$ |
(0.33 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.20 |
) |
|
$ |
(0.99 |
) |
Weighted-average number
of Ordinary Shares used to compute basic and diluted net loss per
share |
|
|
24,335,774 |
|
|
|
13,585,810 |
|
|
|
22,249,391 |
|
|
|
13,585,810 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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CONSOLIDATED BALANCE SHEETS |
|
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|
U.S. dollars in
thousands |
|
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|
|
|
|
|
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|
June 30, 2017 |
|
December
31, |
|
|
|
|
2016 |
|
|
Unaudited |
|
|
|
|
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Assets: |
|
|
|
|
|
|
|
|
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Cash and
cash equivalents |
|
$ |
43,544 |
|
$ |
23,215 |
|
|
|
|
|
|
|
Other
assets |
|
|
5,431 |
|
|
4,943 |
|
|
|
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|
Total
assets |
|
$ |
48,975 |
|
$ |
28,158 |
|
|
|
|
|
|
|
Liabilities and shareholders' equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
$ |
4,338 |
|
$ |
6,357 |
|
|
|
|
|
|
|
Liability
related to warrants |
|
|
24,391 |
|
|
7,078 |
|
|
|
|
|
|
|
Other
non-current liabilities |
|
|
445 |
|
|
412 |
|
|
|
|
|
|
|
Shareholders' equity |
|
|
19,801 |
|
|
14,311 |
|
|
|
|
|
|
|
Total
liabilities and shareholders' equity |
|
$ |
48,975 |
|
$ |
28,158 |
|
|
|
|
|
|
|
Contacts:
Marylyn Rigby
Senior Director, Investor Relations and Marketing
925-272-4999
mrigby@steadymed.com
The Ruth Group
Lee Roth
(646) 536-7012
lroth@theruthgroup.com
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