scPharmaceuticals Inc. Reports First Quarter 2019 Financial Results and Provides Business Update
May 08 2019 - 8:00AM
scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company
focused on developing and commercializing products that have the
potential to optimize the delivery of infused therapies, advance
patient care, and reduce healthcare costs, today announced
financial results for the first quarter ended March 31, 2019 and
provided a business update.
“We enter 2019 with good momentum and an increasingly clear line
of sight on what we need to accomplish to refile our NDA for
FUROSCIX in 2020,” said John Tucker, president and chief executive
officer of scPharmaceuticals. “We look forward to working with the
FDA in June to solidify refiling requirements. In the interim, we
anticipate initiating our first human factors study using our next
generation delivery device, the West Pharmaceutical Services, Inc.
(West) SmartDose® drug delivery system with FUROSCIX. In addition,
we continue to advance new development work with furosemide, the
active drug in FUROSCIX, and have filed additional formulation
patents for FUROSCIX, with patent protection extending to 2040.
With a strong balance sheet to support the work required to refile
the NDA for FUROSCIX, we remain committed to our focus of
transforming the treatment of heart failure to improve patient
care, reduce hospitalizations, and lessen healthcare costs.”
Business Highlights
- Regulatory update on FUROSCIX. The Company
submitted a meeting package to the FDA and has scheduled a Type C
Meeting that will take place in June 2019. This Type C Meeting will
be the first meeting the Company has had with the FDA since the
Company elected to expedite the advancement of a next-generation
infusor, which includes a pre-filled cartridge and other device
features expected to address prior FDA requirements. The Company
believes the upcoming meeting with the FDA will solidify plans for
the refiling of FUROSCIX in 2020. FUROSCIX is scPharmaceuticals’
lead product being developed for the treatment of congestion, or
fluid overload, in patients with heart failure.
- The Company plans to initiate and complete first human
factors study in the second quarter of 2019. On January
29, 2019, the Company signed a development agreement with West to
incorporate West’s SmartDose drug delivery system with the
Company’s subcutaneous formulation of furosemide, as the FUROSCIX
Infusor. As part of the transition to the SmartDose system, the
Company is required to conduct a series of human factors studies
under the current 505(b)(2) approval pathway for FUROSCIX. The
human factors studies are designed to evaluate FUROSCIX’s use in a
real world setting to determine if the product is being used
correctly and safely by the intended users of the product. The
Company plans to include the outcome of the human factors studies
in the NDA resubmission.
- Filed provisional patent of FUROSCIX that could extend
protection through 2040. The Company recently filed a
provisional composition of matter patent on a liquid pharmaceutical
formulation containing an increased concentration of furosemide.
Additional method patents were filed on ways of treating
congestion, fluid overload, or hypertension using these
formulations of furosemide. Development work around a new,
increased concentration of furosemide in FUROSCIX offers the
potential to enable greater dosing flexibility.
First Quarter 2019 Financial Results and Financial
Guidance
scPharmaceuticals reported a net loss of $8.7 million in the
first quarter ended March 31, 2019, compared to $8.7 million for
the comparable period in 2018.
Research and development expenses were $6.5 million for the
first quarter ended March 31, 2019, compared to $4.0 million for
the comparable period in 2018. The increase in research and
development expenses for the quarter was primarily due to costs
associated with the transition to the SmartDose system.
General and administrative expenses were $2.3 million for first
quarter ended March 31, 2019, compared to $4.7 million for the
comparable period in 2018. The decrease in general and
administrative expenses for the quarter was primarily due to the
restructuring of the Company’s commercial organization.
scPharmaceuticals ended the first quarter of 2019 with $83.6
million in cash, cash equivalents and restricted cash compared to
$89.7 million as of December 31, 2018. This change reflects the
ongoing investment in product development.
Based on its current operating plan, scPharmaceuticals continues
to forecast 2019 expenditures of $8 - $10 million per quarter,
consistent with prior guidance.
About FUROSCIXFUROSCIX is a proprietary
furosemide solution formulated to a neutral pH to allow for
subcutaneous infusion via a wearable, subcutaneous infusor with
an integrated drug delivery system, for outpatient
self-administration. FUROSCIX is being developed for treatment of
congestion, or fluid overload, in patients with heart failure.
FUROSCIX has the potential to provide an outpatient alternative for
the treatment of worsening heart failure due to congestion.
About scPharmaceuticalsscPharmaceuticals is a
clinical-stage pharmaceutical company focused on developing and
commercializing products that reduce healthcare costs and improve
health outcomes. The Company develops, internally and through
strategic partnerships, products for the subcutaneous,
self-administration of IV-strength treatments in heart failure and
infectious disease. scPharmaceuticals is headquartered in
Burlington, MA. For more information, please visit
scPharmaceuticals.com.
Forward-Looking StatementThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to,
statements regarding the advancement of, and potential timing of
regulatory filings for, FUROSCIX with the West SmartDose drug
delivery system as a next-generation infusor technology; the
Company’s plans with respect to its Type C Meeting with the FDA to
discuss the regulatory path for FUROSCIX and the timing and outcome
of the Company’s human factors studies for FUROSCIX. Any
forward-looking statements in this press release are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to, the Company
conducting the ability of the West SmartDose drug delivery system
to appropriately deliver therapy, the receipt of regulatory
approval for FUROSCIX with the West SmartDose drug delivery system
or any of our other product candidates or, if approved, the
successful commercialization of such products, the risk of
cessation or delay of any of the ongoing or planned clinical trials
and/or our development of our product candidates, and the risk that
the results of previously conducted studies will not be repeated or
observed in ongoing or future studies involving our product
candidates. For a discussion of other risks and uncertainties, and
other important factors, any of which could cause our actual
results to differ from those contained in the forward-looking
statements, see the section entitled “Risk Factors” in the
Company’s most recent Annual Report on Form 10-K on file with the
Securities and Exchange Commission, as well as discussions of
potential risks, uncertainties and other important factors in the
Company’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and the Company undertakes no duty to update this
information unless required by law.
Contacts:Katherine Taudvin, scPharmaceuticals
Inc.781-301-6706ktaudvin@scpharma.com
Christopher F. Brinzey, Westwicke, an ICR
Company339-970-2843chris.brinzey@westwicke.com
scPharmaceuticals Inc. |
|
|
Unaudited
Consolidated Statements of Operations and Comprehensive
Loss |
|
|
(in thousands, except share and per share
data) |
|
|
|
THREE MONTHS ENDED MARCH 31, |
|
|
2018 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
4,048 |
|
|
$ |
6,524 |
|
General and administrative |
4,651 |
|
|
2,323 |
|
Total operating expenses |
8,699 |
|
|
8,847 |
|
Loss from operations |
(8,699 |
) |
|
(8,847 |
) |
Other expense |
(42 |
) |
|
(8 |
) |
Interest income |
351 |
|
|
490 |
|
Interest expense |
(342 |
) |
|
(354 |
) |
Net loss and comprehensive loss |
$ |
(8,732 |
) |
|
$ |
(8,719 |
) |
Net loss per share, basic and diluted |
$ |
(0.47 |
) |
|
$ |
(0.47 |
) |
Weighted—average common shares outstanding, basic and diluted |
18,535,432 |
|
|
18,575,726 |
|
scPharmaceuticals Inc. |
Unaudited
Consolidated Balance Sheet Data |
(in thousands) |
|
DECEMBER 31, 2018 |
|
MARCH 31, 2019 |
Cash, cash equivalents and restricted cash |
$ |
89,660 |
|
|
$ |
83,560 |
|
Working capital |
|
85,220 |
|
|
|
75,715 |
|
Total assets |
|
93,755 |
|
|
|
87,587 |
|
Term loan |
|
9,637 |
|
|
|
9,684 |
|
Accumulated deficit |
|
(96,459 |
) |
|
|
(105,178 |
) |
Total stockholders’ equity |
|
78,744 |
|
|
|
70,398 |
|
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