scPharmaceuticals Inc. Reports – GuruFocus.com

FDA assigns PDUFA action date of October 8, 2022

Continue accelerating commercial readiness activities ahead of the planned launch of FUROSCIX® in Q4 2022, if approved

Ended the first quarter with cash, cash equivalents, restricted cash and investments of $65.6 million

BURLINGTON, Mass., May 16, 2022 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (SCPH), a pharmaceutical company focused on developing and commercializing products that can optimize the delivery of infusion therapies, advance patient care, patients and reduce healthcare costs, today announced financial results for the first quarter ended March 31, 2022 and provided a business update.

Company update

  • announced that the U.S. Food and Drug Administration (FDA) has accepted for review its new New Drug Application (NDA) submission for FUROSCIX, a proprietary formulation of furosemide delivered via an infuser to the body for the treatment of congestion in patients with worsening heart failure, and has set a target action date for the Prescription Drug User-Fee Act (PDUFA) of October 8, 2022. The company expects commercial launch in the fourth quarter of 2022, if it is approved.
  • Continued to advance commercial readiness activities, including:
    • Finalize research on physicians, payers and prices;
    • Communicate FUROSCIX data, including FREEDOM-HF, to pharmacy benefit managers and health plans through its product dossier;
    • Finalization of FUROSCIX distribution partners; and
    • Maintaining the commercial workforce.
  • Accepted for presentation three abstracts at upcoming heart failure medical meetings, including the European Society of Cardiology for Heart Failure 2022 and the 18th Annual Meeting of the American Association of Heart Failure Nurses (AAHFN).
  • Ended the first quarter with cash, cash equivalents, restricted cash and investments of $65.6 million.

“The resubmission and acceptance of our NDA FUROSCIX was a significant achievement for our company and potentially gives us the opportunity to transition to a commercial-stage company,” said John Tucker, Managing Director of scPharmaceuticals. “We believe the NDA addresses all concerns and questions raised in the comprehensive response letter we received from the FDA in December 2020. Accordingly, we are preparing for a commercial launch of FUROSCIX, if approved, in the fourth quarter of this year. .”

First quarter 2022 financial results and financial forecasts

scPharmaceuticals ended the first quarter of 2022 with $65.6 million in cash, cash equivalents, restricted cash and investments, compared to $75.5 million as of December 31, 2021. The Company estimates that its cash, cash equivalents cash, restricted cash and investments are sufficient to fund operations in 2023.

scPharmaceuticals reported a net loss of $7.7 million for the first quarter of 2022, compared to $7.1 million for the comparable period in 2021.

Research and development expenses were $4.3 million for the first quarter of 2022, compared to $4.0 million for the comparable period of 2021. The increase in research and development expenses for the quarter ended March 31, 2022 is mainly due to an increase in clinical study activity, regulatory advisory costs, supplies, personnel costs, device development costs and preclinical study costs, offset by a decrease in pharmaceutical development and clinical consulting costs.

General and administrative expenses were $2.9 million for the first quarter of 2022, compared to $2.7 million for the comparable period of 2021. The increase in general and administrative expenses for the quarter ended March 31, 2022 is mainly attributable to an increase in employee-related expenses. fees and costs related to commercial preparations.

Based on its current operating plan, the Company reiterates its guidance for 2022 and expects a net loss of $43-48 million. As of March 31, 2022, the total number of scPharmaceuticals shares outstanding was 27,371,488.

About FUROSCIX® (furosemide injection) for subcutaneous injection

FUROSCIX is a proprietary, investigational furosemide solution formulated at neutral pH, designed to allow subcutaneous infusion via a portable, pre-programmed drug delivery system on the body, for self-administration on an outpatient basis. FUROSCIX is currently in development for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure who exhibit a reduced response to oral diuretics and which do not require hospitalization. If approved, FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

About scPharmaceuticals

scPharmaceuticals is a pharmaceutical company focused on the development and commercialization of products designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance ambulatory care of certain acute illnesses. The Company’s primary programs focus on subcutaneous self-administration of IV strength treatments in heart failure and infectious diseases. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.

Forward-looking statement

This 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 timing and results of the NDA’s review by the FDA; the significance and potential impact of the FREEDOM-HF clinical trial results and clinical data; the Company’s planned efforts to prepare for the commercialization of FUROSCIX, the timing of the commercial launch and the success of this commercialization, if approved; and the potential benefits, anticipated costs and future plans and expectations for FUROSCIX, if approved; and the company’s financial forecast, including the projected annual loss. All forward-looking statements contained in this press release are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. statements. These risks and uncertainties include, but are not limited to, the risk that the results of a clinical study will not necessarily predict the final results and that one or more of the clinical results could change materially as a result of examinations. more complete data and as patients become available, the risk that the results of a clinical study will be subject to interpretation and that additional analyzes will be necessary and/or may contradict these results, the risk of the capacity of the pump FUROSCIX On-Body to properly administer the treatment, the receipt of regulatory approval for the FUROSCIX On-Body Infusor or any of our other product candidates or, if approved, the successful commercialization of these products, the risk cessation or delay of any of the ongoing or planned clinical trials and/or the development of our product candidates, the risk that the results of previously conducted studies will not be are not repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact device validation, drug stability testing and other research operations. the society. For a discussion of other risks and uncertainties, and other important factors, each of which could cause our actual results to differ materially from those contained in the forward-looking statements, see the section entitled “Risk Factors” in its annual report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission, available on the Securities and Exchange Commission’s website at www.sec.gov, along with Risk Discussions potentials, uncertainties and other important factors within the Company’s subsequent filings with the Securities and Exchange Commission. All information contained in this press release is as of the date of publication, and the Company assumes no obligation to update such information except as required by law.

Katherine Tauvin
scPharmaceuticals Inc., 781-301-6706
[email protected]

Investors:
Hans Vitzthum
LifeSci Advisors, 617-430-7578
[email protected]

scPharmaceuticals Inc.
Unaudited Consolidated Statements of Income
(in thousands, except per share and per share data)
THREE MONTHS ENDED MARCH 31
2021 2022
Operating costs :
Research and development $ 4,009 $ 4,347
general and administrative 2,732 2,893
Total operating expenses 6,741 7,240
Operating loss (6,741 ) (7,240 )
Other income 255 14
interest income 20 13
Interest expense (636 ) (518 )
Net loss and comprehensive loss $ (7,102 ) $ (7,731 )
Net loss per share, basic and diluted $ (0.26 ) $ (0.28 )
Weighted average common shares outstanding, basic and diluted 27,336,724 27,368,354
scPharmaceuticals Inc.
Unaudited consolidated balance sheet data
(in thousands) THE 31ST OF DECEMBER, MARCH, 31ST,
2021 2022
Cash, cash equivalents, restricted cash and investments $ 75,460 $ 65,600
Working capital 63,429 54,051
Total assets 79,037 68,893
term loan 17,159 14,739
Accumulated deficit (189,698 ) (197,429 )
Full shareholder equity 56,470 49,393

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