Private company
scPharmaceuticals (United States)
American pharmaceutical preparations company based in Boston, founded in 20131
In its 2025 annual report the company says: “We are a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations while developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care and reduce healthcare costs. Our approved product, FUROSCIX, consists of our novel formulation of furosemide delivered via West Pharmaceutical Services, Inc.'s, or West’s, on-body infusor, which delivers an 80 mg/10 mL dose over 5 hours.”4
Last updated Oct 20, 2026.
Overview
- IndustryPharmaceutical Preparations1
- HeadquartersBoston1
- Websitewww.scpharmaceuticals.com
- Incorporated inDE3
- Business address25 Burlington Mall Road, Suite 203, Burlington, Ma 018033
- Filer categoryNon-accelerated filer, Smaller reporting company3
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We are a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations while developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care and reduce healthcare costs. Our strategy is to develop therapies for subcutaneous administration that have previously been limited to intravenous, or IV, delivery. By moving delivery away from the high-cost healthcare settings typically required for IV administration, we believe our strategy has the potential to reduce overall healthcare costs and advance the quality and convenience of care. Our approved product, FUROSCIX, consists of our novel formulation of furosemide delivered via West Pharmaceutical Services, Inc.'s, or West’s, on-body infusor, which delivers an 80 mg/10 mL dose over 5 hours. On October 10, 2022, we announced tha…4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Cost of revenue10¢$11.4M
- Research and development11¢$12.1M
- Selling, general and admin71¢$77.6M
- Interest7¢$7.6M
Out of $36.3M in revenue.5 The company lost money this year.
Financial statements
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Revenue | $13.6M5 | $36.3M5 | |||||
| Cost of revenue | $3.8M5 | $11.4M5 | |||||
| Research and development | $15.9M6 | $24.6M7 | $18.1M8 | $16.0M9 | $15.5M10 | $11.8M5 | $12.1M5 |
| Selling, general and admin | $20.6M10 | $53.4M5 | $77.6M5 | ||||
| Operating expenses | $25.8M9 | $36.2M9 | |||||
| Operating income | -$29.7M6 | -$32.9M7 | -$29.9M8 | -$25.8M9 | -$36.2M10 | -$55.4M5 | -$64.8M5 |
| Interest | $1.4M6 | $1.8M7 | $2.6M8 | $2.6M9 | $3.3M10 | $8.1M5 | $7.6M5 |
| Income tax | $06 | $07 | $08 | $09 | $010 | $05 | $05 |
| Net income | -$29.4M6 | -$33.0M7 | -$32.2M8 | -$28.0M9 | -$36.8M10 | -$54.8M5 | -$85.1M5 |
| Earnings per share | -$1.029 | -$1.3010 | -$1.425 | -$1.915 | |||
| Earnings per share (diluted) | -$1.029 | -$1.3010 | -$1.425 | -$1.915 | |||
| Shares (weighted, basic) | 27.4M shares9 | 28.4M shares10 | 38.5M shares5 | 44.5M shares5 | |||
| Shares (weighted, diluted) | 27.4M shares9 | 28.4M shares10 | 38.5M shares5 | 44.5M shares5 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash | $89.5M6 | $72.6M7 | $71.8M8 | $74.3M9 | $71.1M10 | $46.8M5 | $75.7M5 |
| Receivables | $4.5M5 | $11.7M5 | |||||
| Inventory | $1.2M10 | $8.8M5 | $13.9M5 | ||||
| Current assets | $91.9M6 | $75.6M7 | $107.8M8 | $78.3M9 | $123.3M10 | $92.9M5 | $105.8M5 |
| Property, plant and equipment | $69.0K9 | $54.0K10 | $58.0K5 | $56.0K5 | |||
| Total assets | $93.8M6 | $77.3M7 | $109.0M8 | $79.0M9 | $124.2M10 | $94.5M5 | $107.5M5 |
| Accounts payable | $544.0K9 | $1.5M10 | $4.0M5 | $3.9M5 | |||
| Short-term debt | $9.8M9 | ||||||
| Current liabilities | $6.7M6 | $5.2M7 | $9.3M8 | $14.8M9 | $7.4M10 | $13.1M5 | $14.9M5 |
| Long-term debt | $6.8M6 | $18.9M7 | $16.9M8 | $7.4M9 | $36.8M10 | $38.8M5 | $51.4M5 |
| Total liabilities | $15.0M6 | $25.9M7 | $26.9M8 | $22.6M9 | $51.8M10 | $57.3M5 | $94.2M5 |
| Retained earnings | -$189.7M9 | -$226.5M10 | -$281.3M5 | -$366.5M5 | |||
| Shareholders’ equity | $78.7M7 | $51.4M8 | $82.2M9 | $56.5M10 | $72.4M5 | $37.2M5 | $13.3M5 |
| Shares outstanding | 18.6M shares6 | 19.4M shares7 | 27.3M shares8 | 27.4M shares9 | 34.3M shares10 | 36.0M shares5 | 50.1M shares5 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$28.8M6 | -$30.4M7 | -$27.7M8 | -$27.2M9 | -$34.6M10 | -$59.2M5 | -$70.5M5 |
| Stock-based compensation | $2.4M9 | $2.8M10 | $4.9M5 | $5.4M5 | |||
| Capital spending | $9.0K9 | $21.0K10 | $40.0K5 | $21.0K5 | |||
| Free cash flow | -$27.2M | -$34.6M | -$59.3M | -$70.6M | |||
| Cash from investing | $32.1M9 | -$45.9M10 | $20.0M5 | $29.3M5 | |||
| Cash from financing | -$2.5M9 | $77.2M10 | $14.8M5 | $70.1M5 |
Compare scPharmaceuticals (United States) with another company
Corporate structure
scPharmaceuticals (United States) sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of scPharmaceuticals (United States)
- Weiss Asset Management LP Filed SCHEDULE 13G/A on scPharmaceuticals (United States), latest Feb 11, 2026 (2 filings since Nov 12, 2025)
- Laurence W. Lytton Filed SCHEDULE 13G/A on scPharmaceuticals (United States), latest Nov 14, 2025 (3 filings since Apr 29, 2024)
- Orin Hirschman Filed SCHEDULE 13G/A on scPharmaceuticals (United States), latest Nov 10, 2025 (5 filings since Nov 25, 2022)
- TUDOR INVESTMENT CORP ET AL Filed SCHEDULE 13G on scPharmaceuticals (United States), latest Oct 14, 2025
- KING LUTHER CAPITAL MANAGEMENT CORP Filed SCHEDULE 13G/A on scPharmaceuticals (United States), latest Oct 8, 2025 (8 filings since May 20, 2024)
- GLAZER CAPITAL, LLC Filed SCHEDULE 13G on scPharmaceuticals (United States), latest Sep 10, 2025
- Invest A/s Lundbeckfond Filed SC 13G/A on scPharmaceuticals (United States), latest Nov 14, 2024
- ORBIMED ADVISORS LLC Filed SC 13D/A on scPharmaceuticals (United States), latest Aug 15, 2024 (2 filings since Nov 29, 2022)
- 5AM Ventures IV, L.P. Filed SC 13G/A on scPharmaceuticals (United States), latest Feb 14, 2024 (2 filings since Feb 14, 2023)
- ARMISTICE CAPITAL, LLC Filed SC 13G/A on scPharmaceuticals (United States), latest Feb 14, 2024 (2 filings since Feb 14, 2023)
- Rubric Capital Management LP Filed SC 13G on scPharmaceuticals (United States), latest Feb 12, 2024
- Cowen Financial Products LLC Filed SC 13G/A on scPharmaceuticals (United States), latest Feb 2, 2024 (2 filings since Feb 27, 2023)
- scPharmaceuticals (United States) Boston
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What scPharmaceuticals (United States) reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $136.0K5 Dec 31, 2024 | $119.0K5 Dec 31, 2023 | +14.3% |
| Accumulated depreciation | $80.0K5 Dec 31, 2024 | $61.0K5 Dec 31, 2023 | +31.1% |
| Property and equipment, net | $56.0K5 Dec 31, 2024 | $58.0K5 Dec 31, 2023 | −3.4% |
| Operating-lease assets (leased space) | $1.3M5 Dec 31, 2024 | $1.4M5 Dec 31, 2023 | −9.1% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $75.7M5 Dec 31, 2024 | $46.8M5 Dec 31, 2023 | +61.6% |
| Marketable securities, current | $05 Dec 31, 2024 | $29.2M5 Dec 31, 2023 | −100.0% |
| Debt securities available for sale | $29.2M5 Dec 31, 2023 | $47.1M10 Dec 31, 2022 | −38.0% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $13.9M5 Dec 31, 2024 | $8.8M5 Dec 31, 2023 | +57.3% |
| Raw materials | $4.8M5 Dec 31, 2024 | $4.3M5 Dec 31, 2023 | +12.4% |
| Work in process | $7.0M5 Dec 31, 2024 | $4.2M5 Dec 31, 2023 | +67.4% |
| Finished goods | $2.1M5 Dec 31, 2024 | $396.0K5 Dec 31, 2023 | +432.1% |
Properties, in its own words
Our principal executive offices are located in a 9,342 square foot facility in Burlington, Massachusetts. Pursuant to a sublease entered into in August 2023, the term of the lease for our facility extends through August 2029. We lease 1,855 square feet in Salem, New Hampshire. The term of the lease for our Salem, New Hampshire facility extends through August 2026. Our facilities house our research and development, sales, marketing, finance and
administrative activities. We believe that our current facilities are adequate to meet our needs for the foreseeable future and that suitable additional space will be available as and when needed.
Item 2 of the 10-K filed Mar 19, 2025.4
Leadership
Who has led scPharmaceuticals (United States), and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerJohn H. Tucker Nov 16, 2017 to now13
- PresidentJohn H. Tucker Nov 16, 2017 to now13
- Chief financial officerRachael Nokes Jan 3, 2024 to now14
- Chief financial officerTroy A. Ignelzi Nov 16, 2017 to Jan 19, 201815
- Chief operating officerAbraham Ceesay Nov 16, 2017 to Jan 19, 201816
Board members and other officers (13)
- OfficerRachael Nokes Mar 6, 2019 to Jan 23, 202317
- Board memberSara Bonstein Jul 13, 2020 to now18
- Board memberFrederick M. Hudson Jun 21, 2018 to now19
- Board memberMason Freeman Jul 24, 2018 to Jun 11, 202020
- Board memberMinnie Baylor-Henry Jul 24, 2018 to now21
- Board memberAbhay Gandhi Nov 16, 2017 to Nov 16, 201722
- Board memberDorothy Coleman Nov 16, 2017 to Jun 11, 202023
- Board memberJack A. Khattar Nov 16, 2017 to now24
- Board memberJohn H. Tucker Nov 16, 2017 to now13
- Board memberJonathan Silverstein Nov 16, 2017 to Nov 21, 201725
- Board memberKush Parmar Nov 16, 2017 to Jun 21, 201826
- Board memberMette Kirstine Agger Nov 16, 2017 to now27
- Board memberKlaus R. Veitinger Dr. Nov 21, 2017 to now28
Timeline
- Oct 7, 20258-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer29
- Sep 24, 20258-K Entered a material agreement; New debt or obligation30
- Aug 25, 20258-K Entered a material agreement31
- Aug 25, 20258-K Entered a material agreement; Regulation FD disclosure32
- Aug 7, 20258-K Results of operations33
- Jun 9, 20258-K Shareholder vote34
- May 14, 20258-K Results of operations35
- Mar 19, 20258-K Results of operations36
- Jan 10, 20258-K Results of operations; Other events37
- Dec 11, 20248-K Regulation FD disclosure38
- Nov 13, 20248-K Results of operations39
- Aug 14, 20248-K Results of operations40
- Nov 16, 2017New chief executive John H. Tucker becomes CEO13
- 2013Founded Founded1
Calendar
When it reported results
- Aug 7, 2025Reported quarterly or annual results33
- May 14, 2025Reported quarterly or annual results35
- Mar 19, 2025Reported quarterly or annual results36
- Jan 10, 2025Reported quarterly or annual results37
- Nov 13, 2024Reported quarterly or annual results39
- Aug 14, 2024Reported quarterly or annual results40
- Aug 12, 2024Reported quarterly or annual results41
- May 14, 2024Reported quarterly or annual results42
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
207 filings to the SEC since October 2021: 4 annual reports, 13 quarterly reports, 39 major events, 66 insider forms, 36 large holders, 49 other. The latest 20:
- Feb 11, 2026SCHEDULE 13G/A EDGAR
- Nov 19, 2025EFFECT EDGAR
- Nov 19, 2025EFFECT EDGAR
- Nov 19, 2025EFFECT EDGAR
- Nov 14, 2025SCHEDULE 13G/A EDGAR
- Nov 12, 2025SCHEDULE 13G EDGAR
- Nov 10, 2025SCHEDULE 13G/A EDGAR
- Oct 17, 202515-12G EDGAR
- Oct 14, 2025SCHEDULE 13G EDGAR
- Oct 8, 2025SCHEDULE 13G/A EDGAR
- Oct 7, 20254 EDGAR
- Oct 7, 20254 EDGAR
- Oct 7, 20254 EDGAR
- Oct 7, 20254 EDGAR
- Oct 7, 20254 EDGAR
- Oct 7, 20254 EDGAR
- Oct 7, 20254 EDGAR
- Oct 7, 20254 EDGAR
- Oct 7, 20254 EDGAR
- Oct 7, 20254 EDGAR
The 207 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
9 open-market trades by officers, directors and large owners since October 2021: 4 buys and 5 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 13, 2024 | OrbiMed Capital GP VI LLC10% owner | Buy | 500,000 | $4.00 | $2.0M | Form 4 |
| Nov 25, 2022 | ORBIMED ADVISORS LLC10% owner | Buy | 762,380 | $5.25 | $4.0M | Form 4 |
| Oct 10, 2022 | DIEKMAN JOHN D10% owner | Sale | 562,466 | $4.09 | $2.3M | Form 4 |
| Oct 6, 2022 | DIEKMAN JOHN D10% owner | Sale | 37,534 | $5.02 | $188.4K | Form 4 |
| Sep 7, 2022 | 5AM Partners IV, LLC10% owner | Sale | 200,000 | $4.75 | $950.0K | Form 4 |
| Sep 6, 2022 | 5AM Partners IV, LLC10% owner | Sale | 26,622 | $5.52 | $147.0K | Form 4 |
| Apr 11, 2022 | 5AM Opportunities I (GP), LLC10% owner | Sale | 270,000 | $5.00 | $1.4M | Form 4 |
| Dec 3, 2021 | Khattar Jack A.Director | Buy | 5,000 | $3.91 | $19.6K | Form 4 |
| Dec 3, 2021 | Tucker John HPresident and CEO | Buy | 10,000 | $3.96 | $39.6K | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Weiss Asset Management LPSCHEDULE 13G/A, 2 filings Nov 12, 2025 to Feb 11, 202643
- Laurence W. LyttonSCHEDULE 13G/A, 3 filings Apr 29, 2024 to Nov 14, 202544
- Orin HirschmanSCHEDULE 13G/A, 5 filings Nov 25, 2022 to Nov 10, 202545
- TUDOR INVESTMENT CORP ET ALSCHEDULE 13G, 1 filing Oct 14, 202546
- KING LUTHER CAPITAL MANAGEMENT CORPSCHEDULE 13G/A, 8 filings May 20, 2024 to Oct 8, 202547
- GLAZER CAPITAL, LLCSCHEDULE 13G, 1 filing Sep 10, 202548
- Invest A/s LundbeckfondSC 13G/A, 1 filing Nov 14, 202449
- ORBIMED ADVISORS LLCSC 13D/A, 2 filings Nov 29, 2022 to Aug 15, 202450
- 5AM Ventures IV, L.P.SC 13G/A, 2 filings Feb 14, 2023 to Feb 14, 202451
- ARMISTICE CAPITAL, LLCSC 13G/A, 2 filings Feb 14, 2023 to Feb 14, 202452
- Rubric Capital Management LPSC 13G, 1 filing Feb 12, 202453
- Cowen Financial Products LLCSC 13G/A, 2 filings Feb 27, 2023 to Feb 2, 202454
- MILLENNIUM MANAGEMENT LLCSC 13G/A, 2 filings Mar 13, 2023 to Jan 12, 202455
- RA CAPITAL MANAGEMENT, L.P.SC 13G/A, 3 filings Feb 14, 2022 to Aug 15, 202256
- Ikarian Capital, LLCSC 13G/A, 1 filing Feb 14, 202257
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | John H. Tucker | 62 | $663.8K | $2.4M58 |
| 2024 | Rachael Nokes | 50 | $439.9K | $1.1M58 |
| 2023 | President and Chief Executive Officer | $603.5K | $1.8M58 | |
| 2023 | Chief Financial Officer | $400.0K | $724.2K58 |
SEC filer profile
How scPharmaceuticals (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARscPharmaceuticals Inc.2
- CIK0001604950
- Employer ID (EIN)46-51840754
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 312
- Industry code (SIC)2834 Pharmaceutical Preparations2
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
- Business address25 Burlington Mall Road, Suite 203, Burlington, MA 018032
- Phone617-517-07302
- Shares outstanding53,298,296 as of Aug 6, 202512
- Public float$118.3B as of Jun 28, 20244
- AuditorRSM US LLP, Boston, Massachusetts PCAOB ID 49; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceApr 7, 20142
- Filings421 in all: 4 (122), 8-K (84), 10-Q (23), 3 (23), SC 13G/A (21), SC 13G (12), S-8 (10), S-8 POS (10)2
All 44 form types
10-K (8), 424B5 (8), DEF 14A (8), DEFA14A (8), SCHEDULE 13G/A (8), EFFECT (7), SC 13D/A (7), CORRESP (6), D (5), SC 14D9/A (5), SC TO-T/A (5), UPLOAD (4), 4/A (3), POS AM (3), S-3 (3), SCHEDULE 13G (3), S-1/A (2), SC 13D (2), SC TO-C (2), SC14D9C (2), SEC STAFF LETTER (2), 10-Q/A (1), 15-12G (1), 25-NSE (1), 424B4 (1), 8-A12B (1), CERTNAS (1), CT ORDER (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), PRE 14A (1), S-1 (1), SC 14D9 (1), SC TO-T (1)
- Latest filingsAnnual report (10-K) Mar 19, 2025
Quarterly report (10-Q) Aug 7, 2025
Proxy statement (DEF 14A) Apr 21, 2025
Latest 8-K (8-K) Oct 7, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common stock, par value $0.0001 | SCPH | The Nasdaq Global Select Market |
From the cover page of the 10-K filed Mar 19, 2025 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks scPharmaceuticals (United States) names in Item 1A of its 10-K filed Mar 19, 2025: 72 risks under these headings, as written.4
- Risks Related to our Products and Product Candidates
- We are heavily dependent on the success of our product candidates and our approved product, FUROSCIX. We cannot give any assurance that we will receive regulatory approval for any product candidates, which is necessary before they can be commercialized.
- There is no assurance that our commercialization efforts with respect to FUROSCIX will be successful or that we will be able to generate revenues at the levels or within the timing we expect or at the levels or within the timing necessary to support our goals.
- Even though we obtained FDA approval for FUROSCIX in the United States, we may never obtain approval for or commercialize it in any other jurisdiction, which would limit our ability to realize its full market potential.
- Clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome. Any difficulties or delays in the commencement or completion, or the termination or
- suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
- We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- Our products and product candidates may have serious adverse, undesirable or unacceptable side effects which may delay or prevent marketing approval. If such side effects are identified during the development of our product candidates or following approval, if any, we may need to abandon our development of such product candidates, the commercial profile of any approved label may be limited, or we may be subject to other significant negative consequences following marketing approval, if any.
- Interim, “topline” and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- Our failure to successfully identify, develop and market additional product candidates could impair our ability to grow.
- The commercial success of FUROSCIX and any product candidates, if approved, depends upon attaining market acceptance by hospital networks, physicians, patients, third-party payers and the medical community.
- If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our approved product, FUROSCIX, we may be unable to generate adequate revenue.
The other 61 risks
- We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do, or limit the market potential of FUROSCIX and our product candidates, if approved.
- If we fail to produce FUROSCIX in the volumes that we require on a timely basis, we may face delays in our commercialization efforts.
- Even if we successfully produce and distribute FUROSCIX, its success will be dependent on the proper use of FUROSCIX by patients, healthcare professionals and caregivers.
- Even in the event of proper use of FUROSCIX by patients, healthcare professionals and caregivers, individual devices may fail.
- Risks Related to Our Financial Position and Capital Requirements
- We have a history of significant operating losses and expect to incur significant and increasing losses for the foreseeable future; we may never achieve or maintain profitability.
- We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability.
- We may not generate substantial revenue from FUROSCIX and may never be profitable.
- We may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts.
- The terms of our credit facility and revenue participation financing facility place restrictions on our operating and financial flexibility, and we may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due.
- Risks Related to Government Regulation
- The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
- Even though the FDA has approved FUROSCIX, we will remain subject to significant post-marketing regulatory requirements and oversight.
- If we are unable to achieve and maintain coverage and adequate levels of reimbursement for FUROSCIX and any of our product candidates, if approved, their commercial success may be severely hindered.
- If the FDA does not conclude that our product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for such product candidates under Section 505(b)(2) are not as we expect, the approval pathway for those product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
- If the FDA or other foreign regulatory authorities approve generic products that compete with FUROSCIX or any of our product candidates, the sales of FUROSCIX or our product candidates, if approved, could be adversely affected.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
- We will need to obtain FDA approval of any proposed product names, and any failure or delay associated with such approval may adversely impact our business.
- Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the United States and require us to develop and implement costly compliance programs.
- Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
- We may be liable if the FDA or other U.S. enforcement agencies determine we have engaged in the off-label promotion of our products or have disseminated false or misleading labeling, advertising or promotional materials.
- Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of any product candidates and commercialize FUROSCIX and may affect the prices we may obtain.
- If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in which we participate, we could be subject to additional
- reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
- Our relationships with customers and payers will be subject to applicable anti-kickback, fraud and abuse, transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
- Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
- Disruptions at the FDA, the SEC and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed, reviewed, approved or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Risks Related to Our Intellectual Property
- Our success depends on our ability to protect our intellectual property and proprietary technology, as well as the ability of our collaborators to protect their intellectual property and proprietary technology.
- It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time and if we do not obtain protection under the Hatch-Waxman Act and similar non-U.S. legislation for extending the term of patents covering each of our products and product candidates, our business may be materially harmed.
- Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
- If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be negatively impacted and our business would be harmed.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.
- A NDA submitted under 505(b)(2) may subject us to a patent infringement lawsuit that would delay or prevent product candidate review or approval.
- Our drug development strategy relies heavily upon the 505(b)(2) regulatory approval pathway, which requires us to certify that we do not infringe upon third-party patents covering approved drugs that we rely upon for approval if we want to obtain approval prior to patent expiry. Such certifications typically result in third-party claims of intellectual property infringement, the defense of which would be costly and time consuming, and an unfavorable outcome in any litigation may prevent or delay our development and commercialization efforts which would harm our business.
- We may not be able to enforce our intellectual property rights throughout the world.
- Others may claim an ownership interest in our intellectual property which could expose us to litigation and have a significant adverse effect on our prospects.
- If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
- Risks Related to Our Reliance on Third Parties
- Use of third parties to manufacture our products and product candidates may increase the risk that we will not have sufficient quantities of our product candidates, products, or necessary quantities at an acceptable cost.
- We rely on third parties to conduct our preclinical studies and clinical trials. If they do not perform satisfactorily or fail to meet expected deadlines, our business could be harmed.
- We enter into various contracts in the normal course of our business in which we indemnify the other party to the contract. In the event we have to perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations.
- We expect to seek to establish collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
- Risks Related to Employee Matters, Managing Growth and Business Operations
- We will need to develop and expand our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.
- We depend heavily on our executive officers, directors, and principal consultants and the loss of their services would materially harm our business.
- Our company lacks experience commercializing products, which may have a material adverse effect on our business.
- Our employees, independent contractors, consultants, collaborators and contract research organizations may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
- We expect to expand our organization and, as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
- We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards.
- Our business could be adversely impacted by climate change, extreme weather conditions and natural disasters.
- General Risk Factors
- Our business and operations may suffer in the event of information technology system failures, cyberattacks or deficiencies in our cybersecurity.
- Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products and product candidates.
- We may become involved in litigation or other proceedings with third parties, which may be time consuming, costly and could result in delays in our development and commercialization efforts.
- Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
- Increased scrutiny of, and evolving expectations regarding, sustainability and environmental, social, and governance (“ESG”) matters could increase our costs, harm our reputation and adversely impact our financial results.
- Risks Related to Ownership of Our Common Stock
- The trading price of our common stock may be highly volatile and fluctuate substantially.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
- We do not anticipate paying any cash dividends on our capital stock in the foreseeable future. Accordingly, stockholders must rely on capital appreciation, if any, for any return on their investment.
- Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.
- We are a “smaller reporting company,” as defined in the Exchange Act, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
- As a public company, we must comply with public company reporting and other obligations. Continued compliance with these requirements will increase our costs and require additional management resources, and do not ensure that we will be able to satisfy them.
Legal proceedings
From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. We are not currently aware of any such proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations.
The opening of Item 3, Legal Proceedings.4
Links
- Websitewww.scpharmaceuticals.com1
- WikidataQ30269296
- SEC EDGARCIK 1604950
Sources
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- 17SEC EDGARRachael Nokes, Officer
- 18SEC EDGARSara Bonstein, Board member
- 19SEC EDGARFrederick M. Hudson, Board member
- 20SEC EDGARMason Freeman, Board member
- 21SEC EDGARMinnie Baylor-Henry, Board member
- 22SEC EDGARAbhay Gandhi, Board member
- 23SEC EDGARDorothy Coleman, Board member
- 24SEC EDGARJack A. Khattar, Board member
- 25SEC EDGARJonathan Silverstein, Board member
- 26SEC EDGARKush Parmar, Board member
- 27SEC EDGARMette Kirstine Agger, Board member
- 28SEC EDGARKlaus R. Veitinger Dr., Board member
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- 31SEC EDGAREntered a material agreement
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- 33SEC EDGARResults of operations
- 34SEC EDGARShareholder vote
- 35SEC EDGARResults of operations
- 36SEC EDGARResults of operations
- 37SEC EDGARResults of operations; Other events
- 38SEC EDGARRegulation FD disclosure
- 39SEC EDGARResults of operations
- 40SEC EDGARResults of operations
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