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SCPH scPharmaceuticals

scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are 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 the outpatient care of select acute conditions. The Company's lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA.

Company profile

SCPH stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

11 Aug 21
24 Oct 21
31 Dec 21
Quarter (USD)
Jun 21 Mar 21 Dec 20 Sep 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 75.15M 75.15M 75.15M 75.15M 75.15M 75.15M
Cash burn (monthly) 289.33K 324.25K 2.15M 2.4M 2.09M 2.41M
Cash used (since last report) 1.11M 1.24M 8.23M 9.18M 7.99M 9.2M
Cash remaining 74.04M 73.91M 66.92M 65.97M 67.16M 65.95M
Runway (months of cash) 255.9 227.9 31.1 27.5 32.1 27.4

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
8 Jun 21 William Tober Abraham Stock Option Common Stock Grant Acquire A No No 5.7 16,300 92.91K 16,300
8 Jun 21 Bonstein Sara Stock Option Common Stock Grant Acquire A No No 5.7 16,300 92.91K 16,300
8 Jun 21 Hudson Frederick M. Stock Option Common Stock Grant Acquire A No No 5.7 16,300 92.91K 16,300
8 Jun 21 Veitinger Klaus R DR Stock Option Common Stock Grant Acquire A No No 5.7 16,300 92.91K 16,300
8 Jun 21 Schaeffer Leonard D Stock Option Common Stock Grant Acquire A No No 5.7 16,300 92.91K 16,300

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

70.5% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 39 47 -17.0%
Opened positions 5 4 +25.0%
Closed positions 13 5 +160.0%
Increased positions 4 17 -76.5%
Reduced positions 23 14 +64.3%
13F shares
Current Prev Q Change
Total value 116.72M 136.76M -14.7%
Total shares 19.28M 20.41M -5.5%
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners
Shares Value Change
Orbimed Advisors 4.8M $29.31M 0.0%
5AM Venture Management 3.83M $23.41M 0.0%
5AM Ventures IV 3.25M $17.21M 0.0%
Ra Capital Management 2.73M $16.69M 0.0%
Ikarian Capital 1.1M $6.69M -16.3%
J. Goldman & Co 720.88K $4.41M +263.3%
AIGH Capital Management 642.15K $3.92M -24.9%
Vanguard 608.95K $3.72M -5.4%
Renaissance Technologies 216.49K $1.32M +13.1%
Russell Investments 194.24K $1.19M NEW
Largest transactions
Shares Bought/sold Change
GS Goldman Sachs 115.26K -533.51K -82.2%
J. Goldman & Co 720.88K +522.45K +263.3%
Alyeska Investment 0 -355.69K EXIT
BLK Blackrock 62.2K -266.97K -81.1%
Ikarian Capital 1.1M -213.68K -16.3%
AIGH Capital Management 642.15K -212.99K -24.9%
Russell Investments 194.24K +194.24K NEW
STT State Street 0 -104.12K EXIT
NTRS Northern Trust 49.89K -64.99K -56.6%
Millennium Management 57.72K +57.72K NEW

Financial report summary

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Risks
  • We are heavily dependent on the success of our product candidates and, in particular, our lead product candidate, FUROSCIX. We cannot give any assurance that we will receive regulatory approval for this product candidate or any other product candidates, which is necessary before they can be commercialized.
  • If we are not able to obtain required regulatory approvals, we will not be able to commercialize FUROSCIX, and our ability to generate revenue will be materially impaired. There is no assurance that, if approved, 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.
  • We intend to utilize the 505(b)(2) pathway for the regulatory approval of FUROSCIX. Final marketing approval of FUROSCIX or any of our other product candidates by the FDA or other regulatory authorities may be delayed, limited, or denied, any of which would adversely affect our ability to generate operating revenues.
  • Additional time may be required to obtain regulatory approval for our product candidates because they are combination products.
  • Even if we obtain 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.
  • The commencement and completion of clinical trials can be delayed or prevented for a number of reasons.
  • Clinical failure may occur at any stage of clinical development, and the results of our clinical trials may not support our proposed indications for our product candidates.
  • Our 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.
  • Our failure to successfully identify, develop and market additional product candidates could impair our ability to grow.
  • The commercial success of FUROSCIX and any other 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 lead product candidate, FUROSCIX, if approved, we may be unable to generate any revenue.
  • 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 our product candidates, if approved.
  • 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 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.
  • If we fail to produce FUROSCIX in the volumes that we require on a timely basis, we may face delays in our commercialization efforts, if it is approved.
  • Even if we successfully obtain approval for, 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.
  • 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 have not generated any 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.
  • 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.
  • If we are unable to achieve and maintain coverage and adequate levels of reimbursement for our product candidates, if approved, their commercial success may be severely hindered.
  • If the FDA or other applicable regulatory authorities approve generic products that compete with any of our product candidates, the sales of our product candidates, if approved, could be adversely affected.
  • An NDA submitted under 505(b)(2) may subject us to a patent infringement lawsuit that would delay or prevent the review or approval of FUROSCIX.
  • 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.
  • Any of our product candidates for which we obtain marketing approval in the future will be subject to ongoing requirements and continued regulatory review, could be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products following approval.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize FUROSCIX and may affect the prices we may obtain.
  • 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.
  • Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.
  • 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 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.
  • 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.
  • Use of third parties to manufacture our 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.
  • If our third-party manufacturers of our product candidates are unable to increase the scale of their production of our product candidates, or increase the product yield of manufacturing, then our costs to manufacture the product may increase and commercialization may be delayed.
  • 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.
  • We only have a limited number of employees to manage and operate our business.
  • 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.
  • Our business and operations would suffer in the event of computer system failures.
  • Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our 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.
  • We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards.
  • 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 an “emerging growth company,” as defined in the JOBS Act and a “smaller reporting company,” as defined in the Exchange Act, and the reduced disclosure requirements applicable to emerging growth companies and 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.
  • Future sales of our common stock into the market could cause the market price of our common stock to decline significantly, even if our business is doing well.
  • If securities or industry analysts do not continue to publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.
  • An active trading market for our common stock may not be sustainable. If an active trading market is not sustained, our ability to raise capital in the future may be impaired.
  • Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management or hinder efforts to acquire a controlling interest in us.
  • Our bylaws designate specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us.
Management Discussion
  • Research and development expenses. R&D expenses were $3.8 million for the three months ended June 30, 2021, compared to $5.1 million for the three months ended June 30, 2020. The decrease of $1.3 million was primarily attributable to a decrease of $1.7 million in device development costs. The decrease was partially offset by a $0.1 million increase in pharmaceutical development costs, a $0.1 million increase in contract services for medical affairs, and a $0.1 million increase in employee-related costs.
  • General and administrative expenses. G&A expenses were $2.6 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020. The increase of $0.1 million was primarily attributable to a $0.2 million increase in consulting fees and a $0.1 million increase in director and officer’s insurance. The increase was partially offset by a $0.2 million decrease in legal costs.
  • Other (expense) income. Other income was $33,000 for the three months ended June 30, 2021, compared to other expense of $1,000 for the three months ended June 30, 2020. The increase in income of $34,000 was primarily attributable to income from a rental arrangement.
Content analysis
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Legalese
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Readability
H.S. freshman Avg
New words: arm, batch, bench, dramatically, evolving, fourth, HEOR, matched, pharmacoeconomic, prespecified, statistical, statistically
Removed: district, IL, Pharma, Phase, SmartDose, Standard, system, trademark, wearable