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STSA Satsuma Pharmaceuticals

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product candidate for the acute treatment of migraine. Its product candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, which is designed to be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. DHE products have long been recommended as a first-line therapeutic option for the acute treatment of migraine and have significant advantages over other therapeutics for many patients. However, broad use has been limited by invasive and burdensome administration and/or sub-optimal clinical performance of available injectable and liquid nasal spray products. STS101 is in Phase 3 development and specifically designed to deliver the clinical advantages of DHE while overcoming these shortcomings.

STSA stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

10 Aug 21
18 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
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) 53.86M 53.86M 53.86M 53.86M 53.86M 53.86M
Cash burn (monthly) 16.12M (positive/no burn) 3.94M 3.91M 3.7M 3.24M
Cash used (since last report) 58.61M n/a 14.33M 14.22M 13.45M 11.79M
Cash remaining -4.75M n/a 39.53M 39.64M 40.41M 42.08M
Runway (months of cash) -0.3 n/a 10.0 10.1 10.9 13.0

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
11 Oct 21 Mutya Harsch Stock Option Common Stock Grant Acquire A No No 4.41 40,000 176.4K 40,000
1 Apr 21 Ra Capital Management Common Stock Other Acquire J Yes No 5.91 192,387 1.14M 5,348,241
1 Apr 21 Ra Capital Management Common Stock Other Acquire J Yes No 5.91 566,011 3.35M 566,011
26 Feb 21 Ra Capital Management Common Stock Buy Acquire P Yes No 5.68 1,232,394 7M 5,155,854
3 Dec 20 Rajeev M. Shah Stock Option Common Stock Grant Acquire A No No 4.6 20,000 92K 20,000

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

83.8% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 60 62 -3.2%
Opened positions 12 17 -29.4%
Closed positions 14 3 +366.7%
Increased positions 14 22 -36.4%
Reduced positions 24 14 +71.4%
13F shares
Current Prev Q Change
Total value 182.07M 172.82M +5.4%
Total shares 26.41M 28.78M -8.2%
Total puts 36.5K 0 NEW
Total calls 0 0
Total put/call ratio Infinity
Largest owners
Shares Value Change
Ra Capital Management 5.91M $41.7M 0.0%
NEA Management 3.14M $22.16M +4.8%
Growth Equity Opportunities 17 2.99M $20.83M 0.0%
Shin Nippon Biomedical Laboratories 2.79M $15.87M 0.0%
TPG 1.89M $13.3M 0.0%
Samlyn Capital 1.58M $11.17M +28.5%
Vivo Capital 1.23M $8.69M 0.0%
Citadel Advisors 1.23M $8.63M -0.9%
Ghost Tree Capital 904.23K $6.38M 0.0%
AMP Ameriprise Financial 646.19K $4.56M NEW
Largest transactions
Shares Bought/sold Change
Commodore Capital 0 -2.43M EXIT
AMP Ameriprise Financial 646.19K +646.19K NEW
Point72 Asset Management 0 -528.17K EXIT
BLK Blackrock 125.37K -458.15K -78.5%
Vanguard 644.3K +432.74K +204.5%
Samlyn Capital 1.58M +351.5K +28.5%
MS Morgan Stanley 352.45K -224.57K -38.9%
STT State Street 18.41K -173.48K -90.4%
NEA Management 3.14M +145.28K +4.8%
Millennium Management 141.78K +126.85K +849.7%

Financial report summary

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Competition
AbbvieZosano Pharma
Risks
  • We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future, which, together with our limited operating history, makes it difficult to assess our prospects.
  • We will require substantial additional financing to achieve our goals, and a failure to obtain this capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
  • Our business is entirely dependent on the successful development, regulatory approval and commercialization of STS101, our only product candidate under development.
  • STS101 has recently failed to demonstrate a statistically significant difference as compared to placebo on either of the co-primary endpoints.
  • The ongoing COVID-19 pandemic and outbreak in the United States may adversely affect our business.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome, and delays can occur for a variety of reasons outside of our control.
  • We may be unable to obtain regulatory approval for STS101 under applicable regulatory requirements. The denial or delay of any such approval would delay commercialization of STS101 and adversely impact our potential to generate revenue, our business and our results of operations.
  • If we encounter difficulties with patient enrollment or completion in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • STS101 may cause undesirable side effects or have other properties that could delay or prevent its regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • We may be unable to rely on Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FDCA), which could result in a longer development program and more costly trials than we anticipate.
  • STS101 is a drug-device combination product, which may result in additional regulatory risks.
  • Interim, “topline” and preliminary data from our clinical trials 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.
  • Even if STS101 obtains regulatory approval, it may fail to achieve broad market acceptance.
  • We face, and will continue to face, significant competition in an environment of rapid technological and scientific change and our failure to effectively compete may prevent us from achieving significant market penetration for STS101, if approved. Most of our competitors have significantly greater resources than we have and we may not be able to successfully compete.
  • The successful commercialization of STS101 will depend in part on the extent to which governmental authorities, private health insurers, and other third-party payors provide coverage, adequate reimbursement levels and implement pricing policies favorable for it. Failure to obtain or maintain coverage and adequate reimbursement for STS101, if approved, could limit our ability to market our product and decrease our ability to generate revenue.
  • We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell STS101 effectively in the United States and foreign jurisdictions, if approved, or generate product revenue.
  • We rely, and intend to continue to rely, on qualified third parties to supply all components of STS101. As a result, we are dependent on several third parties, most of which are sole source suppliers, for the manufacture of STS101 and our supply chain, and if we experience problems with any of these suppliers, or they fail to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, it would materially and adversely affect our business.
  • We rely, and intend to continue to rely, on third-party suppliers for materials used in the manufacture of STS101, and the loss of third-party suppliers or their inability to supply us with adequate key materials could harm our business.
  • We rely, and intend to continue to rely, on third parties in the conduct of all of our clinical trials. If these third parties do not successfully carry out their contractual duties, fail to comply with applicable regulatory requirements or meet expected deadlines, we may be unable to obtain regulatory approval for STS101.
  • The terms of our loan agreement place restrictions on our operating and financial flexibility.
  • We will need to increase the size of our organization, and we may experience difficulties in managing growth.
  • If we fail to attract and retain senior management and key scientific personnel, our business may be materially and adversely affected.
  • We may conduct additional clinical trials and consider additional headache indications for STS101 to enhance its commercial potential; however, these trials may not produce results necessary to enable additional commercial potential or enhancement of its label.
  • Any future collaboration arrangements that we may enter into, may not be successful, which could significantly limit the likelihood of receiving the potential economic benefits of the collaboration and adversely affect our ability to develop and commercialize STS101.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • We or the third parties upon which we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • The lives of our patents may not be sufficient to effectively protect STS101 and our business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Our rights to develop and commercialize STS101 are subject in part to the terms and conditions of a license granted to us by SNBL. The patent protection, prosecution and enforcement for STS101 may be dependent on third parties.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful. Further, issued patents relating to STS101 could be found invalid or unenforceable if challenged in court.
  • We may fail to comply with our obligations under the SNBL License or any future agreements pursuant to which we may license or otherwise acquire intellectual property rights or technology, which could result in the loss of rights or technology that are material to our business.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • Even if we obtain regulatory approval for STS101, STS101 will remain subject to regulatory scrutiny.
  • If STS101 obtains regulatory approval, competitors could enter the market with generic versions, which may result in a material decline in sales of affected products.
  • The successful commercialization of STS101 will depend in part on the extent to which governmental authorities, private health insurers, managed care plans and other third-party payors provide coverage, adequate reimbursement levels and implement pricing policies favorable for STS101. Failure to obtain or maintain coverage and adequate reimbursement for STS101, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize STS101 and may affect the prices we may set.
  • Changes in and failures to comply with U.S. and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance.
  • Our stock price may be volatile and you may not be able to resell shares of our common stock at or above the price you paid.
  • An active, liquid and orderly market for our common stock may not develop.
  • We are an “emerging growth company” and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our common stock may be less attractive to investors.
  • We incur increased costs as a result of operating as a public company, and our management devotes substantial time to compliance initiatives. We may fail to comply with the rules that apply to public companies, including Section 404, which could result in sanctions or other penalties that would harm our business.
  • If we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our stock price may decline.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide for an exclusive forum in the Court of Chancery of the State of Delaware for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
  • Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations.
  • Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Changes in patent law in the U.S. or in other countries could diminish the value of patents in general, thereby impairing our ability to protect STS101.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock or business, our stock price and trading volume could decline.
Management Discussion
  • Research and development expenses decreased by $0.4 million, or 4%, from the three months ended June 30, 2020 to the three months ended June 30, 2021. The decrease in research and development expenses was primarily due to a decrease of $0.4 million in clinical trial costs, which was the net of a $4.5 million decrease in EMERGE efficacy trial costs, as that trial has concluded, offset by increases of $1.5 million for the SUMMIT efficacy trial, $1.4 million for the STS101 Phase 1 trial, and $1.2 million for the ASCEND safety trial, and a $0.3 million decrease in manufacturing fees, partly offset by increases of $0.2 million in payroll and personnel expenses, and $0.1 million in other expenses.
  • General and administrative expenses increased by $0.7 million, or 27%, from the three months ended June 30, 2020 to the three months ended June 30, 2021. The increase in general and administrative expenses was primarily due to an increase of $0.1 million of payroll and personnel expenses, including salaries, benefits and stock-based compensation expenses, an increase of $0.5 million of professional fees for legal, consulting, accounting, tax and other services, and an increase of $0.1 million in marketing expenses due to pre-commercialization activities.
  • Interest income decreased by $0.3 million, or 87%, from the three months ended June 30, 2020 to the three months ended June 30, 2021, which was primarily due to a decrease in average balances of our cash, cash equivalents and marketable securities and as a result of the lower interest yields.
Content analysis
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Legalese
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Readability
H.S. junior Avg
New words: ACSEND, running
Removed: China, Contingency, headcount, home, par, scheduling, standalone, telemedicine, visit, Wuhan