scPharmaceuticals Inc. Reports Fourth Quarter and Year Ended 2018 Financial Results and Provides Business Update
March 21 2019 - 8:00AM
Signed development agreement with West
Pharmaceutical Services for next-generation FUROSCIX® On-Body
Infusor
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 fourth quarter and year ended December 31, 2018 and
provided a business update.
“Based on our interactions with the FDA since June 2018, we have
directed our attention to the activities required to refile a New
Drug Application (NDA) for FUROSCIX, incorporating the
next-generation SmartDose® drug delivery system. We look forward to
2019 being an important year for the Company as we make this
transition,” said John Tucker, president and chief executive
officer of scPharmaceuticals. “We believe transitioning to a
next-generation FUROSCIX Infusor can maximize FUROSCIX’s value to
the underserved heart failure market. With a strong balance
sheet to support the work required to refile an NDA for FUROSCIX
with the FDA, we remain committed to our mission of transforming
infused therapies.”
Business Highlights
- Provided regulatory update on FUROSCIX. The
Company held a Type C Meeting with the FDA in January 2019 to
discuss refiling requirements that were initially discussed in its
Type A Post-Action Meeting, held in October 2018. Based on
its interactions with the FDA since June 2018, including
clarification on an additional dose validation study and proposed
device modifications necessary to advance FUROSCIX using the
existing delivery technology, the Company decided to expedite the
advancement of a next-generation infusor. The new infusor includes
a pre-filled cartridge and other device features expected to
address FDA concerns.
- Announced development agreement with West
Pharmaceutical Services for next-generation FUROSCIX
Infusor. On January 29, 2019, the Company signed a
development agreement with West Pharmaceutical Services, Inc.
(West) to incorporate West’s SmartDose drug delivery system with
FUROSCIX. The SmartDose technology platform, previously
approved by the FDA for use in the U.S. with another combination
product, offers a wearable, subcutaneous injector with
an integrated drug delivery system that adheres to the body
for hands-free, outpatient, self-administration, with the potential
to improve the overall patient experience with FUROSCIX.
- Completed preliminary feasibility studies with
next-generation infusor. scPharmaceuticals recently
completed preliminary feasibility studies on the West SmartDose
drug delivery system, confirming its ability to successfully
deliver the defined volume (10ml) of FUROSCIX.
scPharmaceuticals’ feasibility testing included drug stability in
the pre-filled cartridge, drug compatibility, and overall
performance within FUROSCIX delivery specifications. West has
developed this wearable technology with extensive human factors
testing and analysis to understand the interaction between the
patient and the delivery system.
- Anticipate FUROSCIX NDA to be refiled with the FDA in
2020. The Company plans to request a meeting with the FDA
to define the regulatory path and discuss refiling an NDA for
FUROSCIX with the next-generation infusor. The Company
anticipates refiling the FUROSCIX NDA in 2020.
Fourth Quarter and Year End 2018 Financial Results and
Financial Guidance
scPharmaceuticals reported a net loss of $5.1 million in the
fourth quarter ended December 31, 2018, compared to $6.9 million
for the comparable period in 2017. Research and development
expenses were $3.1 million for the fourth quarter ended December
31, 2018, compared to $3.7 million for the comparable period in
2017. The decrease in research and development expenses for the
quarter ended December 31, 2018 was primarily due to reduced
clinical study activity and drug manufacturing costs in the fourth
quarter of 2018. General and administrative expenses were $2.1
million for fourth quarter ended December 31, 2018, compared to
$3.0 million for the comparable period in 2017. The decrease in
general and administrative expenses for the quarter ended December
31, 2018 was primarily due to the restructuring of the Company’s
commercial organization.
scPharmaceuticals reported a net loss of $29.4 million for the
year ended December 31, 2018, compared to $23.8 million for the
comparable period in 2017. Research and development expenses were
$15.9 million for the year ended December 31, 2018, compared to
$14.3 million for the comparable period in 2017. The increase in
research and development expenses for the year ended December 31,
2018 was largely due to increased headcount and costs associated
with the Company’s clinical and medical affairs program, as well as
pharmaceutical development costs. General and administrative
expenses were $13.7 million for the year ended December 31, 2018,
compared to $9.1 million for the comparable period in 2017. The
increase in general and administrative expenses for the year ended
December 31, 2018 was primarily due to commercial launch
preparation and costs incurred as a public company.
scPharmaceuticals ended the fourth quarter of 2018 with $89.7
million in cash, cash equivalents and restricted cash compared to
$118.5 million as of December 31, 2017. This change reflects the
ongoing investment in product and clinical development, as well as
the costs incurred in the Company’s transition to a public company
and costs associated with preparing for the potential
commercialization of FUROSCIX.
Based on its current operating plan, scPharmaceuticals forecasts
2019 expenditures of $8 - $10 million per quarter, consistent with
prior guidance.
About FUROSCIX
FUROSCIX is a proprietary furosemide solution formulated to a
neutral pH to allow for subcutaneous infusion via a wearable,
subcutaneous injector 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 scPharmaceuticals
scPharmaceuticals 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 to meet with the FDA to discuss the regulatory path
for FUROSCIX with the West SmartDose drug delivery system; the
ability of the SmartDose drug delivery system to successfully
deliver FUROSCIX to patients and improve the patient experience;
and the Company’s financial condition and results of operations for
the fiscal year 2019. 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
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scPharmaceuticals Inc. |
|
Consolidated Statements of Operations and Comprehensive
Loss |
(in thousands, except share and per share data) |
|
|
THREE MONTHS ENDEDDECEMBER 31, |
|
YEAR ENDEDDECEMBER 31, |
|
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|
2017 |
|
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2018 |
|
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|
2017 |
|
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2018 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
3,716 |
|
|
$ |
3,149 |
|
|
$ |
14,331 |
|
|
$ |
15,948 |
|
|
General
and administrative |
|
|
2,992 |
|
|
|
2,074 |
|
|
|
9,105 |
|
|
|
13,719 |
|
|
Total
operating expenses |
|
|
6,708 |
|
|
|
5,223 |
|
|
|
23,436 |
|
|
|
29,667 |
|
|
Loss
from operations |
|
|
(6,708 |
) |
|
|
(5,223 |
) |
|
|
(23,436 |
) |
|
|
(29,667 |
) |
|
Other
(expense) income |
|
|
(7 |
) |
|
|
2 |
|
|
|
75 |
|
|
|
(56 |
) |
|
Interest
income |
|
|
171 |
|
|
|
491 |
|
|
|
341 |
|
|
|
1,712 |
|
|
Interest
expense |
|
|
(336 |
) |
|
|
(370 |
) |
|
|
(797 |
) |
|
|
(1,432 |
) |
|
Net loss
and comprehensive loss |
|
$ |
(6,880 |
) |
|
$ |
(5,100 |
) |
|
$ |
(23,817 |
) |
|
$ |
(29,443 |
) |
|
Net loss
per share, basic and diluted |
|
$ |
(0.80 |
) |
|
$ |
(0.27 |
) |
|
$ |
(8.04 |
) |
|
$ |
(1.59 |
) |
|
Weighted—average common shares outstanding, basic and diluted |
|
|
8,565,779 |
|
|
|
18,569,289 |
|
|
|
2,962,859 |
|
|
|
18,556,126 |
|
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scPharmaceuticals Inc. |
Consolidated Balance Sheet Data |
(in
thousands) |
|
AS OF DECEMBER 31, |
|
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|
|
|
2017 |
|
|
|
2018 |
|
|
|
|
|
Cash,
cash equivalents and restricted cash |
|
$ |
118,480 |
|
|
$ |
89,660 |
|
|
|
|
|
Working
capital |
|
|
114,672 |
|
|
|
85,220 |
|
|
|
|
|
Total
assets |
|
|
122,048 |
|
|
|
93,755 |
|
|
|
|
|
Term
loan |
|
|
9,419 |
|
|
|
9,637 |
|
|
|
|
|
Accumulated deficit |
|
|
(67,016 |
) |
|
|
(96,459 |
) |
|
|
|
|
Total
stockholders’ equity |
|
|
105,997 |
|
|
|
78,744 |
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