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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2022
OR
For the transition period from- to
Commission File Number 001-38293
SCPHARMACEUTICALS INC.
(Exact name of registrant as specified in its Charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
2400 District Avenue, Suite 310
Burlington, Massachusetts
(Address of principal executive offices)
46-5184075
(I.R.S. Employer
Identification No.)
01803
(Zip Code)
Registrant’s telephone number, including area code: (617) 517-0730
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common stock, par value $0.0001
Trading Symbol(s)
SCPH
Name of each exchange on which registered
The Nasdaq Global Select Market
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ NO ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ NO ☒
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Non-accelerated filer
☐
☒
Accelerated filer
Smaller reporting company
Emerging growth company
☐
☒
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the
effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by
the registered public accounting firm that prepared or issued its audit report. ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the
correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the
registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
The aggregate market value of the registrant’s voting and non-voting common equity held by non-affiliates of the registrant computed by reference to the price at which the
common equity was last sold as of the last business day of the registrant’s most recently completed second fiscal quarter (June 30, 2022) was $75,626,427. The number of
shares of the registrant’s common stock, par value $0.0001 per share, outstanding as of March 21, 2023 was 35,769,073.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive proxy statement relating to its 2023 annual meeting of stockholders are incorporated by reference into Part III of this Annual Report on Form
10-K where indicated. The registrant’s definitive proxy statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year
ended December 31, 2022.
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Item 16.
Table of Contents
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Reserved
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
Exhibits, Financial Statement Schedules
Form 10-K Summary
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Summary of the Material and Other Risks Associated with Our Business
Our business is subject to numerous material and other risks and uncertainties that you should be aware of in evaluating our business.
These risks include, but are not limited to, the following:
• We are heavily dependent on the success of our product candidates and our approved product, FUROSCIX® (furosemide
injection). We have only one approved product and we cannot give any assurance that we will receive regulatory approval for any
other product candidates, which is necessary before they can be commercialized.
If we fail to produce FUROSCIX in the volumes that we require on a timely basis, we may face delays in our commercialization
efforts.
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
FUROSCIX, we may be unable to generate any revenue.
•
•
•
• 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 success.
• 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 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.
Our success depends on our ability to manufacture, or the ability of third parties to deliver, sufficient quantities of supplies,
components and drug product for commercialization of FUROSCIX or any of our product candidates, if approved, including our
ability to monitor quality control issues related to the production of FUROSCIX and on-body infusors in the volumes that will be
required on a timely basis.
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.
If we fail to comply with our obligations under our existing and any future intellectual property license with third parties, we could
lose license rights that are important to our business.
• We may be subject to product liability lawsuits related to our products and product candidates, if approved, which could divert our
•
resources, result in substantial liabilities and reduce the commercial potential of our products and product candidates.
The ongoing and evolving COVID-19 pandemic may materially and adversely affect our business and our financial results, including
the activities supporting our commercial launch of FUROSCIX.
Our failure to successfully identify, develop and market additional product candidates could impair our ability to grow.
•
• We depend heavily on our executive officers, directors and principal consultants and the loss of their services would materially harm
our business.
The material and other risks summarized above should be read together with the text of the full risk factors set forth in Part I, Item 1A. “Risk
Factors” and in the other information set forth in this Annual Report on Form 10-K, including our consolidated financial statements and the
related notes, as well as in other documents that we file with the SEC. If any such material and other risks and uncertainties actually occur,
our business, prospects, financial condition and results of operations could be materially and adversely affected. The risks summarized
above or described in full below are not the only risks that we face. Additional risks and uncertainties not currently known to us, or that we
currently deem to be immaterial may also materially adversely affect our business, prospects, financial condition and results of operations.
1
FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains express or implied forward-looking statements within the meaning of the safe harbor provisions of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the
Exchange Act. All statements other than statements of historical fact contained in this Annual Report are forward-looking statements,
including, but not limited to, statements about the marketing and commercialization of FUROSCIX, the timing or likelihood of regulatory filings
and approvals, our plans to develop and commercialize our product candidates, the timing of our ongoing or planned clinical trials, the clinical
utility of FUROSCIX or our product candidates, expectations surrounding the pricing, reimbursement or pharmacoeconomic benefit of
FUROSCIX, expectations surrounding manufacturing capabilities and supply chain matters, our commercialization capabilities and strategy,
the sufficiency of our cash, cash equivalents, restricted cash and short-term investments and our ability to raise additional capital to fund our
operations, our future financial performance, the anticipated impact of the COVID-19 pandemic and general economic conditions on our
business, and the plans and objectives of management for future operations, capital needs and capital expenditures. In some cases, forward-
looking statements can be identified by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology.
The forward-looking statements in this Annual Report on Form 10-K are only predictions. We have based these forward-looking statements
on our management’s beliefs and assumptions and on information currently available to our management. Although we believe that the
expectations reflected in these forward-looking statements are reasonable, you should not place undue reliance on forward-looking
statements because they relate to future events or our future operational or financial performance, and involve known and unknown risks,
uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by these forward-looking statements. Important factors that may cause actual
results to differ materially from current expectations include those described under Part I, Item 1A. “Risk Factors” in this Annual Report on
Form 10-K. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results
may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of
future performance. While we may elect to update these forward-looking statements at some point in the future, we have no current intention
of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as
representing our views as of any date subsequent to the date of this Annual Report on Form 10-K.
As used in this Annual Report on Form 10-K, unless otherwise stated or the context requires otherwise, references to “scPharmaceuticals
Inc.,” the “Company,” “we,” “us,” and “our,” refer to scPharmaceuticals Inc. and its subsidiary on a consolidated basis.
2
Item 1. Business.
OVERVIEW
PART I
We are 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. Our strategy is designed to enable the subcutaneous administration of
therapies 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 technology 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 dose. On October 10, 2022, we announced that the
U.S. Food and Drug Administration, or FDA, approved FUROSCIX for the treatment of congestion due to fluid overload in adults with New
York Heart Association, or NYHA, Class II/III chronic heart failure. FUROSCIX is the first and only FDA-approved subcutaneous loop diuretic
that delivers IV equivalent diuresis at home. IV equivalence was established in a clinical study in which FUROSCIX demonstrated 99.6%
bioavailability (90% CI: 94.8%-104.8%) and 8-hour urine output of 2.7 L which was similar to subjects receiving intravenous furosemide. We
estimate that there is a $6.9 billion total market opportunity for FUROSCIX in the United States. The commercial launch of FUROSCIX
commenced in the first quarter of 2023.
Heart failure affects 7.2 million adults in the United States who collectively experience approximately 4 million heart failure events annually.
An estimated 59% of hospital admissions for heart failure are directly attributable to volume overload. Approximately 80% of heart failure
patients discharged from hospital schedule a follow-up appointment and 25-30% of patients are readmitted to hospital post-discharge within
30 days. Repeat hospitalization for heart failure has been associated with increased mortality, with first-time discharges having a median
survival (50% mortality) of 2.4 years, decreasing to 0.6 years following a fourth hospitalization. Our proprietary formulation of furosemide
administered subcutaneously via an on-body infusor, which we refer to together as FUROSCIX, is intended to help alleviate the signs and
symptoms associated with congestion due to fluid retention in patients with NYHA Class II/III chronic heart failure, such as fatigue and
shortness of breath. FUROSCIX is designed to offer alternative outpatient intervention for heart failure patients who display reduced
responsiveness to oral diuretics in non-emergency situations and do not require hospitalization.
We believe FUROSCIX will allow heart failure patients to receive IV-strength diuresis outside the high-cost hospital setting. At a price of $822
per dose, we estimate the average cost of treatment with FUROSCIX for each heart failure exacerbation (comprising four doses of
FUROSCIX) to be approximately $3,300. Prevention of hospital admission and reduced readmission rates would result in reducing the
estimated 15 million days patients with heart failure spend in the hospital each year. By decreasing the number of admissions and
readmissions to hospitals, we believe we can drive significant cost savings to payers and hospitals.
We are leveraging our subcutaneous formulation expertise to potentially develop additional product candidates that we believe can
significantly decrease the cost of treatment by moving treatment away from the hospital setting and can improve patient quality of life by
eliminating the need for IV catheters. In this area, we have conducted additional development work to develop a proprietary, subcutaneously
administered formulation of ceftriaxone, a parenteral cephalosporin that is typically administered intravenously or intramuscularly. Based on
IMS Health data, each year in the United States, there are 15 million outpatient days of ceftriaxone therapy to treat various types of
infections, including pneumonia, urinary tract infections, and Lyme Disease. The current outpatient treatment option for these patients,
Outpatient Parenteral Antimicrobial Therapy requires the placement of a long-term venous access device, known as a peripherally inserted
central catheter, or PICC, and coordination of home infusion or office-based infusion services for patients to receive antibiotics outside of the
hospital, which places significant burdens on the patients. We believe subcutaneous administration of ceftriaxone represents an opportunity
to reduce costs to the overall health care system and improve the quality of care by reducing the complications and serious health risks
associated with IV catheters and increasing patient mobility and convenience. We have conducted a pharmacokinetic study with
subcutaneous ceftriaxone and intend to conduct additional clinical trials to advance its development.
Beyond furosemide and ceftriaxone, we aim to leverage our subcutaneous formulation expertise to develop and seek approval of additional
product candidates.
3
OUR PLATFORM AND OTHER PIPELINE PROGRAMS
FUROSCIX to Treat Congestion in Patients with Heart Failure
Heart failure is a chronic disease resulting from impairment of the heart’s ability to pump blood and is one of the most common causes of
hospital admissions in patients over 65 with at least 1-2 million hospitalizations in the United States annually. Patients with heart failure are
prone to retaining sodium and water in their blood stream and, as this accumulates, it can distribute to tissues. This extra fluid settling in the
lungs, ankles and abdomen can cause symptoms ranging from weight gain, mild swelling and shortness of breath while walking to more
severe symptoms, such as weakness, severe fatigue and difficulty breathing when sitting or lying down. Congestion is the most common
cause of hospitalization for patients with heart failure.
Oral loop diuretics, such as furosemide, are the mainstay for the management and prevention of congestion in patients with heart failure.
However, during periods of worsening congestion in heart failure, the bioavailability of oral furosemide is reduced and becomes highly
variable. To overcome the limitation of oral furosemide in this setting, two strategies are typically employed. First, the furosemide dose is
typically doubled, and/or additional oral diuretics (thiazide diuretics) are incorporated to attempt to overcome the blunted pharmacological
response to these agents. Second, if this fails, clinicians often rely on giving IV diuretics, either in the hospital, an outpatient heart failure
clinic or an infusion center, if available. Approximately 800,000 patients with symptoms of heart failure are admitted to the hospital by an
emergency physician annually and we believe 50% of these admissions may be potentially avoided if patients could receive timely, effective
treatment for symptomatic congestion outside of the hospital setting.
In addition to potentially unnecessary hospitalizations, it has been estimated that up to 50% of patients hospitalized for an episode of acute
decompensated heart failure are discharged on oral diuretics with persistent signs and symptoms of congestion. The presence of congestion
at discharge has been associated with an increased risk of 30-day all-cause mortality and rehospitalization for heart failure. The American
College of Cardiology Foundation and the American Heart Association Task Force on Practice guidelines recommend that patients
hospitalized for heart failure have a post discharge follow up visit within 14 days of hospital discharge. Since symptoms of congestion
generally worsen over several days or weeks, patients with heart failure may receive FUROSCIX at discharge when congestion has not fully
resolved or at the first signs of worsening congestion post hospitalization.
FUROSCIX therefore offers an alternative outpatient route of administration of furosemide for NYHA Class II/III chronic heart failure patients
to alleviate the signs and symptoms associated with congestion when responsiveness to oral diuretics is reduced and hospitalization is not
indicated in order to potentially avoid unnecessary hospitalizations.
FUROSCIX is our novel formulation of furosemide contained in a pre-filled, Crystal Zenith® cartridge and self- administered subcutaneously
via a single-use, disposable and wearable on-body delivery system. The user inserts the pre-filled cartridge into the wearable device, secures
it to the abdomen via a medical-grade adhesive, and a subcutaneous infusion of FUROSCIX is administered through a pre-programmed,
biphasic delivery profile with 30 mg administered over the first hour, followed by 12.5 mg per hour for the subsequent 4 hours (a total dose of
80 mg (10 mL) over 5 hours).
We believe that FUROSCIX provides a safe and effective solution that will enable IV-strength diuresis outside of the high-cost hospital
setting. We believe FUROSCIX can potentially reduce the estimated 15 million days per year that heart failure patients spend in the hospital
and thus reduce overall health care costs by decreasing both admissions and readmissions.
We believe subcutaneous FUROSCIX has the potential to:
•
Reduce hospital admission rates: Since symptoms of congestion generally worsen over several days or weeks, there is a
window of opportunity to intervene. We believe FUROSCIX could in certain instances avoid a hospitalization by providing IV-
strength diuresis in an outpatient setting such as the physician’s office, a heart failure clinic or at home. It is estimated that 90%
of patients presenting to the emergency department with worsening heart failure are admitted to the hospital and approximately
50% of those patients could potentially be safely discharged after demonstrating effective diuresis with parenteral therapy during
a brief period of observation.
4
•
Reduce patient readmission: We believe FUROSCIX could reduce the incidence of readmission for heart failure patients by
providing IV-strength diuresis in the home post-hospital discharge. It is estimated that 30-50% of patients that are hospitalized
for acute decompensated heart failure that are transitioned to oral furosemide prior to being discharged from the hospital have
persistent symptoms of congestion at discharge. Persistent congestion may reduce the absorption of oral furosemide reducing
the diuretic effect. As a result, patients are often readmitted to the hospital to receive IV furosemide. We believe FUROSCIX can
break this cycle by providing IV-strength diuresis to patients shortly after discharge to reduce the rate of readmissions for
decompensated heart failure.
FUROSCIX offers an outpatient therapeutic option to deliver IV-strength furosemide to potentially avoid the need for unnecessary, expensive
hospitalizations which in turn could improve patients’ quality of life with minimal interruption of daily living.
Clinical Development of FUROSCIX
On October 10, 2022, we announced that the FDA approved FUROSCIX for the treatment of congestion due to fluid overload in adults with
New York Heart Association Class II/III chronic heart failure. FUROSCIX is not indicated for emergency situations or in patients with acute
pulmonary edema. FUROSCIX is a drug-device combination product and was approved pursuant to Section 505(b)(2) of the Federal Food,
Drug and Cosmetic Act, or FDCA, in reliance on the FDA’s previous findings of safety and efficacy for the Listed Drug Furosemide (Injection,
USP, 10 mg/mL; NDA 18667; Hospira, Inc.), which is indicated for intravenous (IV) and intramuscular (IM) injection for the treatment of
edema in adult patients with congestive heart failure, cirrhosis of the liver and renal disease, including nephrotic syndrome. FUROSCIX is
the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home.
FUROSCIX (Furosemide Injection, 80 mg/10 mL) is a novel, pH neutral formulation of furosemide that is administered via a subcutaneous
infusion using a proprietary, wearable, pre-programmed on-body drug delivery system. Other currently available furosemide injection
products are alkaline, with a pH of 8.0 – 9.3. Subcutaneous administration of IV/IM furosemide, USP formulation has been associated with
local skin reactions, some severe, requiring discontinuation of treatment and local treatment of the complication which has been attributed to
the alkaline pH of the furosemide formulation, volume of fluid administered and the rapid injection.
Pharmacokinetic/Pharmacodynamic (PK/PD) Study
We conducted a pivotal, randomized, open-label crossover study from April to September 2015 to assess the relative bioavailability of
FUROSCIX in 17 patients with heart failure. In this study, FUROSCIX was delivered subcutaneously via the B. Braun Perfusor Space
Infusion Pump. This study also evaluated diuresis and the urinary sodium excretion over eight hours and 24 hours post-dosing as the
pharmacodynamic endpoints.
Treatment arms
In this study, the reference treatment was IV furosemide with two bolus injections of 40 mg dosed over two minutes, two hours apart. Our test
treatment was FUROSCIX with 80 mg infused subcutaneously, with 30 mg over the first hour followed by 12.5 mg per hour over the
subsequent four hours.
Comparative pharmacokinetic results
This study demonstrated bioequivalence in the concentration of drug delivered over time based upon the area under the curve, or AUC,
between our subcutaneous formulation of furosemide and IV furosemide. Although the maximum concentration, or Cmax, of furosemide
achieved was four-fold higher with IV injection compared to subcutaneous infusion, the bioavailability of subcutaneous infusion relative to
intravenous injection was 99.6%, with a 90% confidence interval of 94.8% to 104.8%, thus meeting the FDA’s defined bioequivalence criteria
limit of 80% to 125%. We believe that the observed difference in Cmax between IV injection and subcutaneous furosemide is attributable to
the two bolus IV injections administered at the initiation of IV therapy. Nevertheless, the 5-hour infusion of FUROSCIX resulted in nearly
complete bioavailability compared to two bolus IV injections of furosemide.
Comparative pharmacodynamic results
5
Total mean urine outputs for subcutaneous versus IV administration were 102% (2654 mL vs 2641 mL; p = 0.83) and 103% (3630 mL vs
3538 mL; p = 0.71) at 8 and 24 hours, respectively. Total mean urine sodium excretion for subcutaneous versus IV administration were
97.3% (284 mmol vs 292 mmol; p = 0.78) and 97.4% (341 mmol vs 350 mmol; p = 0.80), at 8 and 24 hours, respectively. The total urine
sodium excretion and urine output were comparable between our subcutaneous formulation of furosemide and IV furosemide.
Human Factors Summary
We conducted a human factors validation study for the West on-body infusor from October 21, 2019 to November 14, 2019. The study
included 60 subjects made up of 30 heart failure patients, 15 caregivers and 15 healthcare practitioners. Half of the patients were trained,
while the remaining patients, all caregivers and all HCPs were untrained.
Participants performed extremely well across all user groups and training conditions. All participants but one successfully setup and started
the infusion without experiencing any use errors related to critical tasks which would delay dosing or harm the patient.
All participants successfully noticed, identified, and articulated how to respond to an alarm experienced during an infusion without any use
errors.
All participants successfully allowed the infusion to carry out, noticed when it completed and performed all steps required to remove and
dispose of the on-body infusor without any use errors.
Overall, the study, which was designed to measure eight observational use metrics, across 900 tasks including setup, starting of the infusion,
responding to the on-body infusor alarm and finishing the procedure after the infusion demonstrated a user success rate of 99%.
Participants also performed well during the knowledge and reading comprehension tasks. Thirty-seven knowledge and comprehension tasks
related to critical information were evaluated. Overall, across all 2,220 knowledge and comprehension tasks, participants experienced a user
success rate of over 99.5%.
FREEDOM-HF - Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure
FREEDOM-HF was a health economic study designed to support the commercial reimbursement of FUROSCIX. Further, this multicenter,
prospective adaptive clinical trial was designed to evaluate differences in heart failure and overall costs between subjects receiving
FUROSCIX outside the hospital and patients receiving intravenous furosemide in the hospital setting for 30-days after being discharged from
the emergency department. Differences in costs were determined from a propensity-matched control arm derived from Truven Health
Analytics Market Scan databases. The study was designed to enroll up to 75 subjects in the FUROSCIX cohort to detect a statistically
significant difference in 30-day overall and heart-failure related costs. The study began enrollment in the fourth quarter of 2020 and
completed enrollment in May 2021.
Based on the results from a planned, prespecified interim analysis conducted to confirm the final sample size, and following input from
statisticians, principal investigators, payer advisors and Health Economics and Outcomes Research experts, enrollment was closed on May
17, 2021, prior to the enrollment target of 34 patients. This decision was made due to the statistically significant reduction observed in 30-day
heart failure-related costs in patients who received FUROSCIX in the interim analysis. The final analysis included 24 subjects treated with
FUROSCIX and 66 matched comparators based on seven variables associated with hospitalization. On July 13, 2021, we announced
preliminary top-line results from FREEDOM-HF, demonstrating that average 30-day heart failure-related costs were reduced by $17,753 per
study subject in the FUROSCIX arm compared to historically matched comparators (p < 0.0001). In September 2021, we announced
additional results from FREEDOM-HF, demonstrating that average 30-day total healthcare costs were reduced by $30,568 per study subject
in the FUROSCIX arm compared to historically matched comparators (p < 0.0001). Since the price for FUROSCIX was not established at the
time of study completion, the difference in costs did not include the cost of FUROSCIX. These results support our hypothesis that treating
heart failure patients presenting to the emergency department with worsening congestion with FUROSCIX outside of the hospital setting has
the potential to dramatically reduce the significant costs associated with hospital admissions and readmissions.
6
We conducted an analysis of additional secondary endpoints in FREEDOM-HF which provided additional insights into the clinical
effectiveness of FUROSCIX. In this analysis, it was determined that patients who received FUROSCIX had a median reduction of heart
failure peptide biomarkers from study entry to first visit, and to last visit, of 42.3% and 28%, respectively (p <0.01). In addition, patients who
received FUROSCIX had a 12.8-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Summary Score 30 days
after study entry.
These results have been presented at the Heart Failure Society of America Annual meeting in September 2021 in Denver, Colorado and at
the Technology and Heart Failure Therapeutics Conference in February 2022 in New York, NY.
AT HOME-HF PILOT - Avoiding Treatment in the Hospital with Furoscix for the Management of Congestion in Heart Failure – A Pilot Study
AT-HOME-HF PILOT was a multicenter, randomized pilot clinical trial designed to evaluate the clinical outcomes and safety of FUROSCIX
compared to a “treatment as usual” approach in patients presenting to a heart failure clinic with chronic heart failure and fluid overload
requiring augmented diuretic therapy. The objective of this pilot study was to evaluate prospective endpoints that could inform the design
and sample size of a clinical trial that could be used to seek expansion of the indication for FUROSCIX to include a reduction of
hospitalizations for heart failure or inclusion in treatment guidelines. The primary endpoint was a 30-day hierarchal composite of
cardiovascular death, heart failure hospitalizations, emergency department visits for heart failure and % change of NT-proBNP at day seven
from baseline, utilizing the Finkelstein-Schoenfeld win ratio. The Finkelstein-Schoenfeld win ratio is a statistical method used to compare
composite outcomes for every pair in a clinical trial from the treatment and control group. Pre-defined secondary endpoints were evaluated
from baseline across the 30-day study period and included the number of days alive and heart failure event free, global assessment via
visual analog scale, composite clinical congestion score, 5- and 7-point Likert dyspnea scores, health-related quality of life measured by the
Kansas City Cardiomyopathy Questionnaire, or KCCQ-12, serum creatinine, weight, six-minute walk test and ReDS® (Remote Dielectric
Sensing) lung fluid measurement. The study compared FUROSCIX to a “treatment as usual” approach, was descriptive only and did not
include a powered statistical hypothesis test. The study completed enrollment in the first quarter of 2022. The study enrolled 51 subjects, of
which 34 received FUROSCIX and 17 received “treatment as usual”.
In July 2022, we announced top-line results from the AT HOME-HF Phase 2 Pilot study demonstrating a positive trend in the Finkelstein-
Schoenfeld win ratio in the FUROSCIX group compared to the “treatment as usual” group across multiple analysis populations. Subjects
randomized to FUROSCIX had a 37% reduction in the risk of a heart failure hospitalization relative to patients randomized to “treatment as
usual” at day 30. All pre-defined secondary endpoints measuring symptoms of congestion, quality of life and functional status favored the
FUROSCIX group and included a two kilogram greater weight loss at day three and a 12-point increase in the KCCQ-12 summary score at
day 7 and day 30. There were 11 subjects that experienced 21 adverse events during the 30-day study period that were determined by the
investigator to be related to FUROSCIX. The most common related adverse event was infusion site pain that was mild in severity. There was
one serious adverse event (dehydration) that was assessed by the investigator as possibly related to FUROSCIX, which resolved. During the
30-day study period, there was one death (sudden cardiac death) in the FUROSCIX group which occurred on study day 30 and was
assessed by the investigator to be not related to FUROSCIX.
In September 2022, we announced that subjects in the AT HOME-HF study who received FUROSCIX demonstrated augmented
decongestion compared with patients receiving enhanced oral diuretics as demonstrated by:
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Improved diuresis as measured by a greater reduction in body weight from baseline at study day 3 (2.8 kg vs 0.8 kg, p=0.035);
Improvement from baseline in mean 5-point dyspnea score at day 3 (-0.5 vs. 0.1, p=0.019);
Greater number of patients with markedly or moderately better shortness of breath based on 7-point dyspnea at day 3 (44% vs
6%, p=0.006);
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Clinically relevant improvement from baseline in quality of life as measured by Kansas City Cardiomyopathy questionnaire – 12
(KCCQ-12) summary score at study days 7 and 30 of 8.9 points and 9.3 points, respectively; and
An increase of 55.8 meters in the average six-minute walk distance at day 30 (36.7 vs -19.1 meters, p=.012).
The win-ratio for the hierarchical endpoint of cardiovascular death, heart failure hospitalization, urgent ED/clinic visit for heart failure and the
percentage change in NT-proBNP from baseline at day seven was 1.11 (95% Confidence Interval: 0.48-2.50) favoring the FUROSCIX group.
During the 30-day study period, subjects in the FUROSCIX group spent an average of 23.2 days heart failure event free compared to 14.3 in
subjects receiving enhanced oral diuretics.
In the FUROSCIX group, 14.7% of subjects had a serum potassium level that was less than 3.5 mEq/L during the 30-day study and was
managed effectively with oral potassium supplements.
The results of the AT HOME-HF study showed that subjects receiving subcutaneous FUROSCIX demonstrated augmented decongestion, as
evidenced by a greater reduction in body weight, better dyspnea scores, greater exercise capacity and improvement of health-related quality
of life compared with patients receiving enhanced oral diuretics, or standard treatment, in a Phase 2 pilot study.
Commercialization
The commercial launch of FUROSCIX commenced in the first quarter of 2023. We plan to commercialize FUROSCIX in the United States by
building and utilizing our own commercial infrastructure. We currently intend to focus our commercial efforts on the United States market,
which we believe represents the largest market opportunity for FUROSCIX. In addition, we plan to seek collaborations with third-party
partners outside of the United States to distribute our products in foreign markets, if approved by the relevant foreign regulatory authorities.
We believe that we can effectively commercialize FUROSCIX in the United States with an initial specialty sales force of approximately 40
field-based sales representatives. We intend to initially pursue a highly-concentrated target market, which consists of approximately 400
hospitals, associated clinics and office-based practices that, collectively account for approximately 40% of all IV furosemide administered to
heart failure patients based on current IMS Drug Distribution Data. We also plan to target the top ten Medicare Part D plans, which cover
80% of Medicare Part D patients. We conducted payer research on 14 payers, representing 22 to 29 million total Medicare lives. We found
that reducing readmissions and increasing patient comfort were ranked as important potential attributes of FUROSCIX by the health plans
and pharmacy benefit managers that were surveyed.
We intend to build a highly concentrated commercial infrastructure focused on distribution, promotion and customer support to healthcare
providers in our key hospital targets and in office-based practices. Our target call points within these hospitals and practices will include heart
failure specialists, cardiologists, emergency room doctors and heart failure nurse practitioners. To date, our market research with 309
healthcare professionals has indicated that 93% of our target prescribers would adopt FUROSCIX, with 80% intending to adopt FUROSCIX
in the first six months of product availability. Furthermore, within the prescriber group of heart failure specialists, cardiologists and nurse
practitioners that we intend to target, the intent to adopt is 93%, 96% and 94%, respectively, and 89%, 88% and 86%, respectively, of those
prescribers intend to adopt in the first six months of product availability. Based on our market research, healthcare professionals perceive the
top potential advantages of FUROSCIX as the ability to treat in the home setting, prevention of hospitalization, and avoidance of IV
placement, while the lowest perceived barriers to adoption identified in the survey were the preference to monitor in a hospital setting,
sufficiency of current medications and hospital guidelines or protocols. In addition, based on a last two patient exercise conducted in our
quantitative market research with healthcare professionals, when given the option to change their prior treatment choice to FUROSCIX, 65%
of healthcare practitioners in a clinic setting and 40% in a hospital setting responded that they would prescribe our product candidate. We
expect to supplement our outside sales force with inside sales representatives and people in the medical science, nursing and
reimbursement fields to support the proper training and utilization of FUROSCIX.
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As part of our commercialization strategy, we plan to educate hospitals, healthcare practitioners, patients and caregivers of the benefits of
FUROSCIX and its proper use. We plan to work with national associations, such as the Heart Failure Society of America and the American
Association of Heart Failure Nurses, hospital networks and individual hospitals to update treatment and issue guidelines to include
subcutaneous furosemide outpatient treatment plans. These guidelines are intended to provide information to hospitals and healthcare
practitioners regarding treatment of outpatient heart failure patients with subcutaneous furosemide.
Eligible patients with heart failure may receive FUROSCIX at the initial worsening signs and symptoms when the response to oral diuretics is
not adequate. In addition, patients can receive FUROSCIX after discharge, if they still are exhibiting some signs and symptoms of
congestion despite their oral diuretic regimen. FUROSCIX is packaged as individual, single use only on-body infusor kits. In April 2016, we
held a meeting with the Centers for Medicare and Medicaid Services, or CMS, at which CMS stated that coverage and reimbursement of
FUROSCIX may be available under Medicare Part D as a transition of care drug.
By educating patients on the proper use of FUROSCIX shortly after discharge followed by a face-to-face visit, health care professionals can
ensure proper training, initiate treatment at the point of care, and ensure that patients can receive additional days of treatment in the home
setting.
Our Pipeline Programs
Beyond our initial focus on heart failure, our strategy is to identify and develop additional product candidates that we believe, if successfully
developed and approved, could provide effective and convenient subcutaneous therapy that may benefit patients, caregivers and payers.
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scCeftriaxone: We have submitted an investigational new drug application, or IND, for a subcutaneous form of Ceftriaxone, an
antibiotic currently used intravenously for the treatment of infections caused by gram-positive and gram-negative organisms. To
date, we have completed a PK study for our Ceftriaxone formulation, which we refer to as scCeftriaxone. We are currently
evaluating a suitable on-body delivery system to administer scCeftriaxone.
scCarbapenem: We have completed several IND-enabling studies for our subcutaneous Carbapenem program, which we refer
to as scCarbapenem, an antibiotic currently used intravenously for the treatment of infections caused by gram-negative
organisms.
Ceftriaxone
Many patients with an infection requiring IV antibiotics are admitted to the hospital, and a portion of these patients will require subsequent
outpatient treatment with IV administration requiring insertion of a PICC line catheter. Ceftriaxone is a parenteral antibiotic commonly used to
treat various types of infections, including pneumonia, bone and joint infections, blood stream infections, urinary tract infections and Lyme
Disease. According to 2015 data from Arlington Medical Resources, ceftriaxone is the second most utilized antibiotic in the hospital setting
and second most utilized IV antibiotic at hospital discharge. Based on Option Care data from August 2016, ceftriaxone represents the largest
segment of antibiotics prescribed in the outpatient setting, accounting for 19% of all outpatient prescriptions. Each year, there are
approximately 15 million outpatient days of ceftriaxone therapy in the United States based on IMS Health data, with 50% of outpatient
ceftriaxone administered to Medicare patients who do not have coverage for home infusion services and frequently must drive to a hospital
clinic, emergency room or physician’s office or be admitted to a skilled nursing facility or hospital to receive IV antibiotics. Subcutaneous
antibiotics, including ceftriaxone, have the potential to reduce the length of hospital stay by facilitating transition of care and eliminating the
risks of complications from long term IV catheters. Such antibiotics could also enhance convenience and independence of patients and
caregivers and potentially reduce the economic burden to payers, particularly in Medicare, by reducing payments for outpatient infusion
services.
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Under an IND we conducted a randomized, partially blinded crossover study of 18 patients to evaluate the PK and bioavailability of a
commercial formulation of ceftriaxone administered subcutaneously as compared to IV administration. In this study, we observed that the
bioavailability of subcutaneous ceftriaxone was 108% of that of IV ceftriaxone. In a PD model based on subcutaneous pharmacokinetics
observed in this study, the T>MIC for the first 24 hours for the ceftriaxone 1-gram subcutaneous infusion was observed to be not inferior to
the 1-gram IV infusion (98.5% vs 100%). The most common adverse event observed with subcutaneous ceftriaxone administration was pain,
with a median pain score of two on a scale of zero to ten (with zero being no pain and ten being the worst possible pain). There were no
serious adverse events reported in this study.
We intend to identify a suitable on-body delivery system for the administration of ceftriaxone subcutaneously, conduct additional studies to
evaluate optimal delivery for ceftriaxone and to evaluate the skin safety of subcutaneous administration of ceftriaxone.
Additional Product Programs
We are leveraging our know-how for use in other clinical settings where subcutaneous delivery can improve IV treatments to develop a suite
of product candidates that, like FUROSCIX, we believe can decrease the cost of treatment by moving treatment out of the hospital setting
and eliminating the need for IV catheters. We expect to pursue the development of a subcutaneous carbapenem to treat infections caused by
gram-negative infections and have completed initial feasibility work on a potential candidate. We also intend to identify other opportunities
where subcutaneous delivery can improve patient treatment and reduce healthcare costs. We intend to evaluate market criteria to
systematically choose potential product programs for our pipeline. We plan to look for product candidates that we believe allow us to clearly
demonstrate value to patients and the healthcare system and that have large market potential and a concentrated specialty physician
prescribing base. We expect to leverage our FUROSCIX sales force to promote additional products that we develop and commercialize.
Our FUROSCIX On-Body Infusor
The FUROSCIX On-Body Infusor is a drug-device combination product consisting of FUROSCIX (furosemide injection, 80 mg per 10 mL), a
novel, pH neutral furosemide formulation optimized for subcutaneous administration and contained in a prefilled, Crystal Zenith® cartridge,
and a proprietary wearable, pre-programmed on-body delivery system, the FUROSCIX On-Body Infusor, based on West's proprietary on-
body infusor. The FUROSCIX On-Body Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion
of FUROSCIX through a pre-programmed, biphasic delivery profile over 5 hours.
MANUFACTURE OF OUR PRODUCTS AND PRODUCT CANDIDATES
We use a network of qualified suppliers or contract manufacturing organizations, or CMOs, to produce, manufacture, sterilize and assemble
the component parts of FUROSCIX and our product candidates. Our suppliers produce these component parts to our designs and
specifications. Certain processes utilized in the manufacture and test of our product candidates have been verified and validated as required
by the FDA and other regulatory bodies. The manufacturing facilities of our suppliers are subject to periodic inspection by the FDA and
certain corresponding state agencies, and we regularly audit our suppliers’ processes in an effort to ensure conformity with the specifications,
policies and procedures for our product candidates.
We believe that our current third-party manufacturers have capacity of FUROSCIX in quantities sufficient to meet our expected commercial
needs and to accommodate the manufacturing of materials for future clinical trials of candidates in our pipeline.
In order to meet projected global demand for FUROSCIX, we plan to support an increase in production capacity at West’s and our
pharmaceutical manufacturing partners' facilities.
INTELLECTUAL PROPERTY
Proprietary protection
Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our drug candidates, manufacturing
and process discoveries and other know-how, to operate without infringing the proprietary rights of others, and to prevent others from
infringing on our proprietary rights. We and our partners have been building and continue to build our intellectual property portfolio relating to
our product candidates and
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technology. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and certain foreign patent
applications related to our proprietary technology, inventions and improvements that are important to the development and implementation of
our business. We also intend to rely on trade secrets, know-how, continuing technological innovation, and potential in-licensing opportunities
to develop and maintain our proprietary position. We cannot be sure that patents will be granted with respect to any of our pending patent
applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any
patents that may be granted to us or our partners in the future will be commercially useful in protecting our technology.
Patent rights
Patent life determination depends on the date of filing of the application and other factors as promulgated under the patent laws. In most
countries, including the United States, the patent term is generally 20 years from the earliest claimed filing date of a non-provisional patent
application in the applicable country.
Furosemide formulations
As of February 8, 2023, we own a patent family directed to the composition of matter of our subcutaneous formulation of furosemide and
methods of treating edema, hypertension or heart failure using the formulation of furosemide having a concentration of about 2 mg/mL to
about 20 mg/mL. This patent family includes U.S. Patent Nos. 9,884,039 and 11,433,044, directed to methods of treatment, U.S. Patent No.
10,272,064, directed to liquid pharmaceutical formulations, one pending U.S. patent application, one granted patent in each of Canada,
China and Europe, two granted patents in Japan, one pending patent application in Europe, and seven granted patents and five pending
patent applications in other countries outside of the United States. Patents that issue from this patent family are generally expected to expire
in 2034, excluding any additional term in the United States for patent term adjustment. U.S. Patent Nos. 9,884,039; 10,272,064; and
11,433,044 are scheduled to expire in April 2034.
We also own a patent family directed to compositions of matter of liquid pharmaceutical formulations containing an increased concentration
of furosemide and methods of treating congestion, edema, fluid overload, or hypertension using these formulations of furosemide. This
patent family includes U.S. Patent Nos. 11,497,755; 11,559,535; and 11,571,434 directed to liquid pharmaceutical formulations, two pending
U.S. patent applications, one pending patent application in each of Canada, China, Europe and Japan, and 12 pending patent applications in
other countries outside of the United States. Patents that issue from this patent family are generally expected to expire in 2040, excluding
any additional term in the United States for patent term adjustment. U.S. Patent Nos. 11,497,755; 11,559,535; and 11,571,434 are scheduled
to expire in January 2040.
Trade secret and other protection
In addition to patented intellectual property, we also rely on trade secrets and proprietary know-how to protect our technology and maintain
our competitive position, especially when we do not believe that patent protection is appropriate or can be obtained. Our policy is to require
each of our employees, consultants and advisors to execute a confidentiality and inventions assignment agreement before beginning their
employment, consulting or advisory relationship with us. The agreements generally provide that the individual must keep confidential and not
disclose to other parties any confidential information developed or learned by the individual during the course of the individual’s relationship
with us except in limited circumstances. These agreements generally also provide that we shall own all inventions conceived by the individual
in the course of rendering services to us.
Other intellectual property rights
We file trademark applications and pursue registrations in the United States and abroad when appropriate. We own trademark registrations
in the U.S. and E.U. for the marks SCPHARMACEUTICALS and FUROSCIX.
From time to time, we may find it necessary or prudent to obtain licenses from third-party intellectual property holders.
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COMPETITION
Our industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. We face
competition and potential competition from a number of sources, including pharmaceutical and biotechnology companies, generic drug
companies, drug delivery companies and academic and research institutions. Some of these companies are developing therapies that are
directly competitive to our approach, and others are more generally developing therapies to treat heart failure. These companies include but
are not limited to: Abbott Laboratories, Amgen, AstraZeneca, Bayer, Bioheart, Boston Scientific, Boehringer Ingelheim, GlaxoSmithKline,
Johnson & Johnson, Eli Lilly and Company, Merck & Co., Medtronic, Novartis, Pfizer, Roche, Sanofi, Sarfez Pharmaceuticals, Servier
Pharmaceuticals, SQ Innovation and Takeda Pharmaceutical Company. We believe the key competitive factors that will affect the
development and commercial success of our product candidates include ease of administration and convenience of dosing, therapeutic
efficacy, safety and tolerability profiles and cost. Many of our potential competitors have substantially greater financial, technical and human
resources than we do, as well as more experience in the development of product candidates, obtaining FDA and other foreign regulatory
approvals of products, and the commercialization of those products. Consequently, our competitors may develop similar products for the
treatment of heart failure or for other indications we may pursue in the future, and such competitors’ products may be more effective, better
tolerated and less costly than our product candidates. Our competitors may also be more successful in manufacturing and marketing their
products than we are. We will also face competition in recruiting and retaining qualified personnel and establishing clinical trial sites and
patient enrollment in clinical trials.
GOVERNMENT REGULATION
Government authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among other
things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion,
advertising, distribution, marketing and export and import of products such as those we are developing.
U.S. drug development process
In the United States, the FDA regulates drugs, medical devices and drug-device combination products under the FDCA and its implementing
regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and local statutes
and regulations require the expenditure of substantial time and financial resources. The process required by the FDA before a drug may be
marketed in the United States generally involves the following:
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completion of preclinical laboratory tests, animal studies and formulation studies in accordance with Good Laboratory Practice
regulations, or GLPs, and other applicable regulations;
submission to the FDA of an IND, which must become effective before human clinical trials may begin;
approval by an independent institutional review board, or IRB or ethics committee at each clinical site before each trial may be
initiated;
performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practice regulations, or
GCPs, to evaluate the safety and efficacy of the product candidate for its intended use;
submission to the FDA of a New Drug Application, or NDA, after completion of all pivotal trials;
satisfactory completion of an FDA advisory committee review, if applicable;
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess
compliance with current Good Manufacturing Practice requirements, or cGMPs to assure that the facilities, methods and
controls are adequate to preserve the drug’s identity, strength, quality and purity, and of potential inspection of selected clinical
investigation sites to assess compliance with GCPs; and
FDA review and approval of the NDA to permit commercial marketing of the product for particular indications for use in the
United States.
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Once a product candidate is identified for development, it enters the preclinical testing stage. Preclinical tests include laboratory evaluations
of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical tests,
together with manufacturing information and analytical data, to the FDA as part of an IND. An IND is a request for authorization from the FDA
to administer an investigational drug product to humans. An IND will also include a protocol detailing, among other things, the objectives of
the clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, if the trial includes an efficacy
evaluation. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after
receipt by the FDA, unless the FDA, within the 30-day time period, places the clinical trial on a clinical hold. In such a case, the IND sponsor
and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any
time before or during clinical trials due to safety concerns about on-going or proposed clinical trials or non-compliance with specific FDA
requirements, and the trials may not begin or continue until the FDA notifies the sponsor that the hold has been lifted.
All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCPs, which include the
requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials must be
conducted under protocols detailing the objectives of the trial, dosing procedures, subject selection and exclusion criteria and the safety and
effectiveness criteria to be evaluated. Each protocol must be submitted to the FDA as part of the IND, and a separate submission to the
existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol
amendments. While the IND is active, progress reports summarizing the results of the clinical trials and nonclinical studies performed since
the last progress report, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be
submitted to the FDA and investigators for serious and unexpected suspected adverse events, findings from other studies suggesting a
significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to
humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or
investigator brochure.
Furthermore, an independent IRB at each institution participating in the clinical trial must review and approve each protocol before a clinical
trial commences at that institution and must also approve the information regarding the trial and the consent form that must be provided to
each trial subject or his or her legal representative, monitor the study until completed and otherwise comply with IRB regulations. The FDA or
the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being
exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical
trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to
patients. In addition, some clinical trials are overseen by an independent group of qualified experts organized by the sponsor, known as a
data safety monitoring board or committee. Depending on its charter, this group may determine whether a trial may move forward at
designated check points based on access to certain data from the trial. There are also requirements governing the reporting of ongoing
clinical studies and clinical study results to public registries, including clinicaltrials.gov.
Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
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Phase 1: The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance,
absorption, metabolism, distribution and excretion and, if possible, to gain an early indication of its effectiveness.
Phase 2: The product candidate is administered to a limited patient population with a specified disease or condition to identify
possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product candidate for specific targeted
diseases and to determine dosage tolerance and appropriate dosage.
Phase 3: The product candidate is administered to an expanded patient population to further evaluate dosage, to provide
substantial evidence of efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.
These clinical trials are intended to establish the overall risk-benefit ratio of the product candidate and provide an adequate
basis for product labeling.
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Post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval. These trials are used to
gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate
the performance of Phase 4 clinical trials as a condition of approval of an NDA.
During the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior to
submission of an IND, at the end of Phase 2, and before an NDA is submitted. Meetings at other times may be requested. These meetings
can provide an opportunity for the sponsor to share information about the data gathered to date, for the FDA to provide advice, and for the
sponsor and the FDA to reach agreement on the next phase of development.
Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the
chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in
accordance with cGMPs. The manufacturing process must be capable of consistently producing quality batches of the product candidate
and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug. In
addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product
candidate does not undergo unacceptable deterioration over its shelf life.
U.S. review and approval process
The results of product development, preclinical and other non-clinical studies and clinical trials, along with descriptions of the manufacturing
process, analytical tests conducted on the chemistry of the drug, proposed labeling and other relevant information are submitted to the FDA
as part of an NDA requesting approval to market the product. The submission of an NDA is subject to the payment of substantial user fees; a
waiver of such fees may be obtained under certain limited circumstances.
The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing, to determine
whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA
for filing. In this event, the NDA must be resubmitted with the additional information. The resubmitted application also is subject to review
before the FDA accepts it for filing. Once filed, the FDA reviews an NDA to determine, among other things, whether a product is safe and
effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality
and purity. Under the Prescription Drug User Fee Act, or PDUFA, guidelines that are currently in effect, the FDA has a goal of ten months
from the date of “filing” of a standard NDA for a new molecular entity to review and act on the submission, or ten months from the date of
receipt for a drug that is not a new molecular entity.
The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts,
including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should
be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such
recommendations carefully when making decisions. Before approving an NDA, the FDA will typically inspect the facility or facilities where the
product is manufactured. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance
with GCPs.
After the FDA evaluates an NDA and conducts inspections of manufacturing facilities where the investigational product and/or its drug
substance will be produced, the FDA may issue an approval letter or a Complete Response Letter, or CRL. An approval letter authorizes
commercial marketing of the drug with prescribing information for specific indications. A CRL indicates that the review cycle of the application
is complete, and the application will not be approved in its present form. A CRL usually describes the specific deficiencies in the NDA
identified by the FDA and may require additional clinical data, such as an additional clinical trial or other significant and time-consuming
requirements related to clinical trials, nonclinical studies or manufacturing. If a CRL is issued, the sponsor must resubmit the NDA or,
addressing all of the deficiencies identified in the letter, or
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withdraw the application. Even if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for
approval.
If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use
may otherwise be limited, which could restrict the commercial value of the product. In addition, the FDA may require a sponsor to conduct
Phase 4 testing, which involves clinical trials designed to further assess a drug’s safety and effectiveness after NDA approval, and may
require testing and surveillance programs to monitor the safety of approved products which have been commercialized. The FDA may also
place other conditions on approval including the requirement for a risk evaluation and mitigation strategy, or REMS, to assure the safe use of
the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS. The FDA will not approve the
NDA without an approved REMS, if required. A REMS could include medication guides, physician communication plans or elements to
assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. Any of these limitations on
approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products.
In addition, the Pediatric Research Equity Act, or PREA, requires a sponsor to conduct pediatric clinical trials for most drugs, for a new active
ingredient, new indication, new dosage form, new dosing regimen or new route of administration. Under PREA, original NDAs and
supplements must contain a pediatric assessment unless the sponsor has received a deferral or waiver. The required assessment must
evaluate the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing
and administration for each pediatric subpopulation for which the product is safe and effective. The sponsor or FDA may request a deferral of
pediatric clinical trials for some or all of the pediatric subpopulations. A deferral may be granted for several reasons, including a finding that
the drug is ready for approval for use in adults before pediatric clinical trials are complete or that additional safety or effectiveness data needs
to be collected before the pediatric clinical trials begin. The FDA must send a non-compliance letter to any sponsor that fails to submit the
required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation.
Regulation of Combination Products in the United States
Certain products may be comprised of components, such as drug components and device components that would normally be regulated
under different types of regulatory authorities, and frequently by different centers at the FDA. These products are known as combination
products. Specifically, under regulations issued by the FDA, a combination product may be:
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a product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and
produced as a single entity;
two or more separate products packaged together in a single package or as a unit and comprised of drug and device products,
device and biological products, or biological and drug products;
a drug, or device, or biological product packaged separately that according to its investigational plan or proposed labeling is
intended for use only with an approved individually specified drug, or device, or biological product where both are required to
achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved
product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or
significant change in dose; or
any investigational drug, or device, or biological product packaged separately that according to its proposed labeling is for use
only with another individually specified investigational drug, device, or biological product where both are required to achieve the
intended use, indication, or effect.
Under the FDCA and its implementing regulations, the FDA is charged with assigning a center with primary jurisdiction, or a lead center, for
review of a combination product. The designation of a lead center generally eliminates the need to receive approvals from more than one
FDA component for combination products, although it does not preclude consultations by the lead center with other components of the FDA.
The determination of which center will be the lead center is based on the “primary mode of action” of the combination product. Thus, if the
primary mode of action of a drug-device combination product is attributable to the drug product, the FDA center responsible for premarket
review of the drug product would have primary jurisdiction for the combination
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product. The FDA has also established an Office of Combination Products to address issues surrounding combination products and provide
more certainty to the regulatory review process. That office serves as a focal point for combination product issues for agency reviewers and
industry. It is also responsible for developing guidance and regulations to clarify the regulation of combination products, and for assignment
of the FDA center that has primary jurisdiction for review of combination products where the jurisdiction is unclear or in dispute.
A combination product with a drug primary mode of action generally would be reviewed and approved pursuant to the drug approval
processes under the FDCA. In reviewing the NDA or 505(b)(2) application for such a product, however, FDA reviewers in the drug center
could consult with their counterparts in the device center to ensure that the device component of the combination product met applicable
requirements regarding safety, effectiveness, durability and performance. In addition, under FDA regulations, combination products are
subject to cGMP requirements applicable to both drugs and devices, including the Quality System Regulations, or QSRs, applicable to
medical devices.
Orphan drug designation
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug intended to treat a rare disease or condition, which is a disease
or condition that affects fewer than 200,000 individuals in the United States or, if it affects more than 200,000 individuals in the United States,
there is no reasonable expectation that the cost of developing and making a drug product available in the United States for this type of
disease or condition will be recovered from sales of the product. Orphan designation must be requested before submitting an NDA. After the
FDA grants orphan designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan
designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.
If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such
designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to
market the same drug for the same disease or condition for seven years, except in limited circumstances, such as a showing of clinical
superiority to the product with orphan exclusivity or inability to manufacture the product in sufficient quantities. The designation of such drug
also entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee
waivers. However, competitors, may receive approval of different products for the indication for which the orphan product has exclusivity or
obtain approval for the same product but for a different indication for which the orphan product has exclusivity. Orphan exclusivity also could
block the approval of a competing product for seven years if a competitor obtains approval of the “same drug,” as defined by the FDA, or if a
product candidate is determined to be contained within the competitor’s product for the same disease or condition. In addition, if an orphan
designated product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan
exclusivity.
Expedited development and review programs
The FDA has a number of programs intended to expedite the development or review of a marketing application for a new drug. For example,
the fast track designation program is intended to expedite or facilitate the process for developing and reviewing product candidates that meet
certain criteria. Specifically, investigational drugs are eligible for fast track designation if they are intended to treat a serious or life-threatening
disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. The sponsor of a fast track
product candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and,
once an NDA is submitted, the product candidate may be eligible for priority review. With regard to a fast track product candidate, the FDA
may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a
schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is
acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.
A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy
designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if preliminary clinical
evidence indicates that the product candidate, alone or in combination with one or more other drugs or biologics, may demonstrate
substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects
observed early in clinical development. The designation includes all of the fast track program features, as well as more intensive
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FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of
the product candidate, including involvement of senior managers.
Any product candidate submitted to the FDA for approval, including a product candidate with a fast track designation or breakthrough
designation, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority review and
accelerated approval. An NDA is eligible for priority review if the product candidate is designed to treat a serious condition, and if approved,
would provide a significant improvement in safety or efficacy compared to marketed products. The FDA will attempt to direct additional
resources to the evaluation of an application for a new drug designated for priority review in an effort to facilitate the review. The FDA
endeavors to review applications with priority review designations within six months of the filing date as compared to ten months for review of
new molecular entity NDAs under its current PDUFA review goals. For non-new molecular entity NDAs, these six- and ten-month review
periods are measured from the date that the FDA receives the application.
In addition, a product candidate may be eligible for accelerated approval. Drug products intended to treat serious or life-threatening diseases
or conditions may be eligible for accelerated approval upon a determination that the product candidate has an effect on a surrogate endpoint
that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or
mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the
severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may
require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled confirmatory clinical trials. Drugs
receiving accelerated approval may be subject to expedited withdrawal procedures if the sponsor fails to conduct the required confirmatory
trials in a timely manner or if such trials fail to verify the predicted clinical benefit. In addition, the FDA currently requires as a condition of
accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.
Fast track designation, breakthrough therapy designation, priority review, and accelerated approval do not change the standards for approval
but may expedite the development or approval process. Even if a product candidate qualifies for one or more of these programs, the FDA
may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval
will not be shortened.
Post-approval requirements
Any products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA,
including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product
sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as
adding new indications, certain manufacturing changes and additional labeling claims, are subject to further FDA review and approval. Drug
manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments
with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for
compliance with cGMPs and other laws and regulations. Changes to the manufacturing process are strictly regulated, and, depending on the
significance of the change, may require prior FDA approval before being implemented. Accordingly, manufacturers must continue to expend
time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory
compliance.
The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the
product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated
severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the
approved labeling to add new safety information; imposition of requirements for post-market studies or clinical studies to assess new safety
risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among
other things:
•
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product
recalls;
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•
•
•
•
•
•
•
•
fines, warning letters, or untitled letters;
clinical holds on clinical studies;
refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of
product approvals;
product seizure or detention, or refusal to permit the import or export of products;
consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;
mandated modification of promotional materials and labeling and the issuance of corrective information;
the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or
other safety information about the product; or
injunctions or the imposition of civil or criminal penalties.
In addition, the FDA closely regulates the marketing, labeling, advertising and promotion of drug products. A company can make only those
claims relating to safety and efficacy that are consistent with FDA approved labeling. The FDA and other agencies actively enforce the laws
and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things,
adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available
products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-
label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients
in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict
manufacturer’s communications on the subject of off-label use of their products.
Marketing exclusivity
Market exclusivity provisions under the FDCA can delay the submission or the approval of certain marketing applications. The FDCA
provides a five-year period of non-patent data exclusivity within the United States to the first applicant to obtain approval of an NDA for a new
chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active
moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept
for review an abbreviated new drug application, or ANDA, or an NDA submitted under Section 505(b)(2), or 505(b)(2) NDA, submitted by
another company for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as
the original innovative drug or for another indication, where the applicant does not own or have a legal right of reference to all the data
required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-
infringement to one of the patents listed with the FDA by the innovator NDA holder.
The FDCA alternatively provides three years of marketing exclusivity for an NDA, or supplement to an existing NDA if new clinical
investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential
to the approval of the application, for example new indications, dosages or strengths of an existing drug. This three-year exclusivity covers
only the modification for which the drug received approval on the basis of the new clinical investigations and does not prohibit the FDA from
approving ANDAs or 505(b)(2) NDAs for drugs containing the active agent for the original indication or condition of use. Five-year and three-
year exclusivity will not delay the submission or approval of a full NDA. However, an applicant submitting a full NDA would be required to
conduct, or obtain a right of reference to, all of the preclinical studies and adequate and well-controlled clinical trials necessary to
demonstrate safety and effectiveness.
Pediatric exclusivity is another type of marketing exclusivity available in the United States. Pediatric exclusivity provides for an additional six
months of marketing exclusivity attached to another period of exclusivity if a sponsor
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conducts clinical trials in children in response to a written request from the FDA. The issuance of a written request does not require the
sponsor to undertake the described clinical trials.
Other U.S. Healthcare Laws and Compliance Requirements
In the United States, our current and future operations are subject to regulation by various federal, state and local authorities in addition to
the FDA, including but not limited to, CMS, other divisions of the U.S. Department of Health and Human Services, or HHS (such as the Office
of Inspector General, Office for Civil Rights and the Health Resources and Service Administration), the U.S. Department of Justice, or DOJ,
and individual U.S. Attorney offices within the DOJ, and state and local governments. These laws include but are not limited to, the Anti-
Kickback Statute, the federal False Claims Act, the federal Physician Payments Sunshine Act, and other state and federal laws and
regulations.
The Anti-Kickback Statute makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf) to
knowingly and willfully solicit, receive, offer, or pay any remuneration that is intended to induce the referral of business, including the
purchase, order, or prescription of a particular drug, for which payment may be made under a federal healthcare program, such as Medicare
or Medicaid. Violations of this law are punishable by up to five years in prison, criminal fines, administrative civil money penalties, and
exclusion from participation in federal healthcare programs. In addition, a person or entity does not need to have actual knowledge of the
statute or specific intent to violate it in order to have committed a violation.
The federal False Claims Act prohibits anyone from knowingly presenting, or causing to be presented, for payment to federal programs
(including Medicare and Medicaid) claims for items or services, including drugs, that are false or fraudulent, claims for items or services not
provided as claimed, or claims for medically unnecessary items or services. Although we would not submit claims directly to payors,
manufacturers can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example,
providing inaccurate billing or coding information to customers or promoting a product off-label. In addition, our future activities relating to the
reporting of wholesaler or estimated retail prices for our products, the reporting of prices used to calculate Medicaid rebate information and
other information affecting federal, state, and third-party reimbursement for our products, and the sale and marketing of our products, are
subject to scrutiny under this law. Moreover, the government may assert that a claim including items or services resulting from a violation of
the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.
In addition, the Civil Monetary Penalties Law prohibits, among other things, the offering or giving of remuneration, which includes, without
limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid
beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services
reimbursable by a federal or state governmental program.
HIPAA also created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to
execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or
promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer
(e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any
materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare
matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific
intent to violate it in order to have committed a violation. Many states also have similar fraud and abuse statutes or regulations that apply to
items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.
Additionally, there has been a recent trend of increased foreign, federal, and state regulation of payments and transfers of value provided to
health care professionals or entities. The federal Physician Payments Sunshine Act imposes annual reporting requirements on certain drug,
biologics, medical supplies and device manufacturers for which payment is available under Medicare, Medicaid or CHIP for payments and
other transfers of value provided by them, directly or indirectly, to physicians (defined to include doctors, dentists, optometrists, podiatrists
and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse
anesthetists, anesthesiologist assistants and certified nurse midwives), and teaching hospitals, as well as ownership and investment interests
held by physicians and their immediate family members. Certain foreign countries and U.S. states also mandate implementation of
commercial compliance programs,
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impose restrictions on device manufacturer marketing practices and require tracking and reporting of gifts, compensation and other
remuneration to health care professionals and entities.
Violations of any of such laws or any other governmental regulations that apply may result in penalties, including, without limitation,
administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, reporting obligations
and integrity oversight, exclusion from participation in federal and state healthcare programs and imprisonment.
Coverage and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any product candidate for which we obtain regulatory approval.
In the United States and markets in other countries, sales of any product candidates for which we receive regulatory approval for commercial
sale will depend, in part, on the availability of coverage and reimbursement from third-party payers. Third-party payers include government
authorities, managed care providers, private health insurers and other organizations. Our ability to commercialize any products successfully
also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be
available from third-party payers. Third-party payers decide which therapeutics they will pay for and establish reimbursement levels.
Coverage and reimbursement by a third-party payer may depend upon a number of factors, including the third-party payer’s determination
that use of a therapeutic is:
•
•
•
•
•
a covered benefit under its health plan;
safe, effective and medically necessary;
appropriate for the specific patient;
cost-effective; and
neither experimental nor investigational.
The process for determining whether a payer will provide coverage for a product may be separate from the process for setting the
reimbursement rate that the payer will pay for the product. Third-party payers may limit coverage to specific products on an approved list, or
formulary, which might not include all of the FDA-approved products for a particular indication. A decision by a third-party payer not to cover
our product candidates could reduce physician utilization of our products, if approved, and have a material adverse effect on our sales,
results of operations and financial condition. Moreover, a payer’s decision to provide coverage for a product does not imply that an adequate
reimbursement rate will be approved. Adequate third-party reimbursement may not be available to enable us to maintain price levels
sufficient to realize an appropriate return on our investment in product development.
In addition, coverage and reimbursement for products can differ significantly from payer to payer. One third-party payer’s decision to cover a
particular medical product or service does not ensure that other payers will also provide coverage for the medical product or service, or will
provide coverage at an adequate reimbursement rate. As a result, the coverage determination process will require us to provide scientific and
clinical support for the use of our products to each payer separately and will be a time-consuming process.
Third-party payers are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products
and services, in addition to their safety and efficacy. Obtaining reimbursement for our products may be particularly difficult because of the
higher prices often associated with branded drugs and drugs administered under the supervision of a physician. We may need to conduct
expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to
the costs required to obtain FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. Obtaining
coverage and reimbursement approval of a product from a government or other third-party payer is a time-consuming and costly process that
could require us to provide to each payer supporting scientific, clinical and cost-effectiveness data for the use of our product on a payer-by-
payer basis, with no assurance that coverage and adequate reimbursement will be obtained. A third-party payer’s decision to provide
coverage for a product does not imply that an adequate reimbursement rate will be approved. Further, in the United States, no uniform policy
of coverage and reimbursement for products exists among third-party payers. Private third-party payers tend to follow Medicare coverage
and reimbursement limitations to a substantial degree, but also have their own methods and approval process apart from Medicare
determinations. Therefore, one payer’s determination to provide coverage for a product does not assure that other payers will also provide
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coverage for the product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize
an appropriate return on our investment in product development. If reimbursement is not available or is available only at limited levels, we
may not be able to successfully commercialize any product candidate that we successfully develop.
Outside of the United States, the pricing of pharmaceutical products and medical devices is subject to governmental control in many
countries. For example, in the EU, pricing and reimbursement schemes vary widely from country to country. Some countries provide that
products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional
studies that compare the cost-effectiveness of a particular therapy to currently available therapies or so-called health technology
assessments, in order to obtain reimbursement or pricing approval. Other countries may allow companies to fix their own prices for products,
but monitor and control product volumes and issue guidance to physicians to limit prescriptions. Efforts to control prices and utilization of
pharmaceutical products and medical devices will likely continue as countries attempt to manage healthcare expenditures.
The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if third-party payers fail
to provide coverage and adequate reimbursement. In addition, emphasis on managed care, the increasing influence of health maintenance
organizations, and additional legislative changes in the United States has increased, and we expect will continue to increase, the pressure on
healthcare pricing. The downward pressure on the rise in healthcare costs in general, particularly prescription medicines, medical devices
and surgical procedures and other treatments, has become very intense. Coverage policies and third-party reimbursement rates may change
at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory
approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
Healthcare Reform
A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third-party payers have
attempted to control costs by limiting coverage and the amount of reimbursement for particular medical products. For example, in March
2010, the ACA was enacted, which, among other things, increased the minimum Medicaid rebates owed by most manufacturers under the
Medicaid Drug Rebate Program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate
Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; extended the Medicaid Drug Rebate Program to
utilization of prescriptions of individuals enrolled in Medicaid managed care plans; imposed mandatory discounts for certain Medicare Part D
beneficiaries as a condition for manufacturers’ outpatient drugs coverage under Medicare Part D; subjected drug manufacturers to new
annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs; imposed a new federal excise tax on the
sale of certain medical devices; created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in and conduct
comparative clinical effectiveness research, along with funding for such research; and established the Center for Medicare and Medicaid
Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending.
Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA. On June 17, 2021, the
U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the
“individual mandate” was repealed by Congress. Thus, the ACA will remain in effect in its current form. Further, prior to the U.S. Supreme
Court ruling, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance
coverage through the ACA marketplace from February 15, 2021 through August 15, 2021. The executive order instructed certain
governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others,
reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary
barriers to obtaining access to health insurance coverage through Medicaid or the ACA.
Other legislative changes have been proposed and adopted since the ACA was enacted. On March 11, 2021, the American Rescue Plan Act
of 2021 was signed into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer
price, or AMP, beginning January 1, 2024. Moreover, there has recently been heightened governmental scrutiny over the manner in which
manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries, and proposed and enacted
legislation designed, among other things, to bring more transparency to product pricing, review the relationship
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between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. Most
recently, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law. Among other things, the IRA requires
manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject
to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);
and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025). The IRA permits the Secretary
of the Department of Health and Human Services (HHS) to implement many of these provisions through guidance, as opposed to regulation,
for the initial years. For that and other reasons, it is currently unclear how the IRA will be effectuated.
Payment methodologies may also be subject to changes in healthcare legislation and regulatory challenges. For example, in order for a drug
product to receive federal reimbursement under the Medicaid or Medicare Part B programs or to be sold directly to U.S. government
agencies, the manufacturer must extend discounts to entities eligible to participate in the 340B drug pricing program. For the 2018 and 2019
fiscal years, CMS altered the reimbursement formula from Average Sale Price, or ASP, plus 6 percent to ASP minus 22.5 percent on
specified covered outpatient drugs, or SCODs, but did so without issuing a formal notice of proposed rulemaking, which was subsequently
challenged in court. In June 2022, the U.S. Supreme Court held that although the Department of Health and Human Services, or HHS, has
authority to set reimbursement rates based on average price and discretion to “adjust” the price up or down, HHS may not vary the
reimbursement rates by hospital group unless it conducts a survey of hospitals’ acquisition costs. Accordingly, the U.S. Supreme Court held
that HHS’s changes to the 2018 and 2019 reimbursement rates for 340B hospitals were unlawful. Based on the foregoing, CMS issued a
final rule, effective January 1, 2023, pursuant to which CMS will pay 340B hospitals under Medicare Part B for certain outpatient drugs at the
drug’s ASP, plus 6%, the same rate used for non-340B hospitals. It is unclear how future changes to the payment methodology may affect
pharmaceutical manufacturers and hospitals who purchase their products now and in the future.
Individual states in the United States have also increasingly passed legislation and implemented regulations designed to control
pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and
marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk
purchasing.
We expect that the other healthcare reform measures that may be adopted in the future, may result in additional reductions in Medicare and
other healthcare funding, more rigorous coverage criteria, lower reimbursement, and new payment methodologies. This could lower the price
that we receive for any approved product. Any denial in coverage or reduction in reimbursement from Medicare or other government-funded
programs may result in a similar denial or reduction in payments from private payors, which may prevent us from being able to generate
sufficient revenue, attain profitability or commercialize our product candidates, if approved.
Data Privacy and Security Laws
Numerous state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and security of
health-related and other personal information, and could apply now or in the future to our operations or the operations of our partners. In the
United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and
security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other
personal information. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data. Privacy
and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts,
and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data
processing.
Cybersecurity
In the normal course of business, we may collect and store personal information and certain sensitive company information, including
proprietary and confidential business information, trade secrets, intellectual property, information regarding trial participants in connection
with clinical trials, sensitive third-party information and employee information. While we have certain cybersecurity measures in place, our
security measures cannot guarantee that a significant cyberattack will not occur. A successful attack on our information technology systems
could have significant consequences to the business. While we devote resources to our security measures to protect our systems and
information, these measures cannot provide absolute security. See “Risk Factors –
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General Risk Factors” for additional information about the risks to our business associated with a breach or compromise to our information
technology systems.
Human Capital Management
As of March 21, 2023, we had 96 full-time employees, including 10 in technical operations and product development, 14 in clinical
development and medical affairs, regulatory affairs, and quality assurance, 20 in commercial, 40 sales representatives and 12 in finance,
general administrative and executive administration. All of our employees are located in the U.S., and none are represented by a labor union
or are parties to a collective bargaining agreement. We believe our efforts in managing our workforce have been effective.
Recruitment, Retention and Culture
We recognize that our future success depends on our ability to attract, develop and retain key personnel, maintain our strong company
culture, and ensure diversity and inclusion in our Board of Directors, management and broader workforce. We launched FUROSCIX in
February 2023 after successfully building an experienced commercial team and expanded commercial organization to support our future
growth. During this period of expansion, we remain committed to our core values and key human capital-related objectives including
effectively recruiting, retaining, incentivizing and integrating our existing and new employees, maintaining and growing a diverse and
inclusive workforce, and ensuring a robust culture of compliance. A testament to our strong culture is our third year in a row earning a spot in
the Boston Business Journal’s Best Places to Work list for companies of our size.
Diversity, Equity and Inclusion (DEI)
Diversity, equity and inclusion are fundamental to our success and future innovation. We are intentional about including diverse points of
view, perspectives, experiences, backgrounds and ideas in our decision-making and hiring processes and practices. For example, the
consideration of individuals from underrepresented groups was a key hiring factor during the expansion of the commercial part of our
organization.
As of March 21, 2023, approximately 33% of our Board of Directors self-identified as female. As of March 21, 2023, approximately 11% of
our Board of Directors were individuals from underrepresented groups, i.e., those self-identifying as Black or African American, Hispanic or
Latinx, Asian, or being of two or more races. Two members of our Board of Directors are military veterans.
Compensation and Benefits
We have designed a broad-based compensation and benefits program that is designed to attract, retain and motivate our employees and
believe that our efforts have been successful in this regard. In addition to base salaries and annual bonuses, these programs include a
401(k) plan with generous eligibility and matching features, healthcare and insurance benefits, equity awards, educational assistance and an
employee stock purchase plan. Furthermore, benefits are extended to domestic partners.
We are committed to ensuring fair and equitable pay for all of our employees including across genders and underrepresented groups. Our
Board of Directors and senior leadership team strongly support this commitment.
Corporate Information
We were formed as a limited liability company under the laws of the State of Delaware in February 2013 under the name scPharmaceuticals
LLC and we converted to a corporation under the laws of the State of Delaware in March 2014 under the name scPharmaceuticals Inc. Our
website address is www.scpharmaceuticals.com.
Available Information
We file electronically with the Securities and Exchange Commission, or SEC, our annual reports on Form 10-K, quarterly reports on Form 10-
Q, current reports on Form 8-K, proxy statements and other information. Our SEC filings are available to the public over the Internet at the
SEC's website at www.sec.gov. We make available on our website at www.scpharmaceuticals.com, under “Investor Relations,” free of
charge, copies of these reports as soon as reasonably practicable after filing or furnishing these reports with the SEC. The information
contained in
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the websites referenced in this Annual Report on Form 10-K is not incorporated by reference into this Annual Report on Form 10-K.
INFORMATION ABOUT OUR EXECUTIVE OFFICERS AND DIRECTORS
The following information with respect to our Board of Directors and executive officers is presented as of the date of this Annual Report on
Form 10-K:
Name
Executive Officers
John H. Tucker
Rachael Nokes
Non-Employee
Directors
Jack A. Khattar
Age
Position at scPharmaceuticals
Principal Employment
60
President, Chief Executive Officer and
Same
Director
48
Chief Financial Officer
Same
61
Chairman of the Board and Director
William T. Abraham, M.D. 63
Director
Mette Kirstine Agger
58
Director
Minnie Baylor-Henry
75
Director
Sara Bonstein
42
Director
Frederick Hudson
Leonard D. Schaeffer
77
77
Director
Director
Klaus Veitinger, M.D., Ph.
D.
61
Director
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President and Chief Executive Officer of Supernus
Pharmaceuticals, a public pharmaceutical company
Chief Medical Officer of V-Wave Ltd., a privately held
medical device company, and College of Medicine
Distinguished Professor at The Ohio State University
Chief Executive Officer and Strategic Advisor of Ersum
Biotech
President of B-Henry & Associates, a regulatory and
compliance strategy consulting company
Chief Financial Officer of Insmed Incorporated, a public
biopharmaceutical company
Former Partner of KPMG, LLP
Partner of North Bristol Partners LLC, a privately held
consulting company
Venture Partner of OrbiMed Advisors LLC, a healthcare
investment firm
Item 1A. Risk Factors.
Investing in our common stock involves a high degree of risk. You should carefully consider the following risks and uncertainties, together
with all other information in this Annual Report on Form 10-K, including our consolidated financial statements and related notes and
“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before investing in our common stock. Any of the
risk factors we describe below could adversely affect our business, financial condition or results of operations. The market price of our
common stock could decline if one or more of these risks or uncertainties actually occur, causing you to lose all or part of the money you paid
to buy our common stock. Additional risks that we currently do not know about or that we currently believe to be immaterial may also impair
our business. Certain statements below are forward-looking statements. See “Forward-Looking Statements” in this Annual Report on Form
10-K.
Risks Related to our Products and Product Candidates
Risks Related to Approval and Commercialization of 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.
To date, we have expended significant time, resources and effort on the development of our product candidates and our approved product,
FUROSCIX, which we announced in October 2022 was approved by the U.S. Food and Drug Administration, or FDA. A substantial majority
of our resources have also been focused on the commercial launch of FUROSCIX in the United States, which commenced in the first quarter
of 2023. Our business and future success are substantially dependent on our ability to successfully commercialize FUROSCIX for the
treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure. All of our product
candidates are in early stages of development and subject to the risks of failure inherent in developing drug products. Accordingly, our ability
to generate significant product revenues in the near term will depend almost entirely on our ability to successfully commercialize FUROSCIX.
We are not permitted to market any of our product candidates in the United States until we receive approval of a new drug application, or
NDA, from the U.S. Food and Drug Administration, or FDA, or in any foreign jurisdiction until we receive the requisite approvals from such
jurisdiction. There can be no assurance that the FDA will approve any of our product candidates, which is necessary before they can be
commercialized. Satisfaction of regulatory requirements can be protracted, is dependent upon the type, complexity and novelty of the product
candidate and requires the expenditure of substantial resources. The time required to obtain approval by the FDA and comparable foreign
regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon
numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and
amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary
among jurisdictions. The FDA has substantial discretion in the drug approval process, including the ability to delay, limit or deny approval of a
product candidate for many reasons. We cannot predict whether we will obtain regulatory approval to commercialize any of our product
candidates, and we cannot, therefore, predict the timing of any future revenues from these product candidates, if any. Any further delay or
setback in the regulatory approval or commercialization of any of these product candidates will adversely affect our business.
Even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications
than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly
post-marketing clinical trials, may impose distribution or use restrictions, or may approve a product candidate with a label that does not
include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing
scenarios could materially harm the commercial prospects for our product candidates.
In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive
compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to
the FDA or other foreign regulatory authorities. The FDA or other foreign regulatory authorities may conclude that a financial relationship
between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA or other
regulatory authorities may therefore question the integrity of the data generated at the applicable clinical trial site and the
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utility of the clinical trial itself may be jeopardized. This could result in a delay in approval or rejection of our marketing applications by the
FDA or other foreign regulatory authorities, as the case may be, and may ultimately lead to the denial of marketing approval of one or more
of our product candidates.
We expect to rely on third-party consultants to assist us in filing and supporting the applications necessary to gain marketing approvals.
Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory
authorities for each therapeutic indication to establish a product candidate’s safety and efficacy for that indication. Securing marketing
approval also requires the submission of information about the manufacturing process to, and inspection of manufacturing facilities by, the
regulatory authorities. If we cannot successfully obtain approval of our product candidates, our business will be materially harmed and the
price of our common stock will be adversely affected.
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.
FUROSCIX and the activities associated with its development and commercialization, including its design, research, testing, manufacture,
safety, efficacy, recordkeeping, labeling, packaging, storage, approval, advertising, promotion, sale and distribution, are subject to
comprehensive regulation by the FDA and other regulatory agencies in the United States and similar foreign regulatory authorities outside
the United States. Failure to obtain marketing approval for FUROSCIX outside the United States will prevent us from commercializing it in
those jurisdictions.
Our ability to successfully commercialize FUROSCIX and any of our products candidates, if approved, will depend, among other things, on
our ability to:
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receive marketing approvals from the FDA and similar foreign regulatory authorities;
produce, through a validated process, sufficiently large quantities of our product candidates to permit successful
commercialization;
establish and maintain commercial manufacturing arrangements with third-party manufacturers;
build and maintain sales, distribution and marketing capabilities sufficient to launch commercial sales of our product candidates;
successfully complete our clinical trials for our product candidates under clinical development;
establish collaborations with third parties for the commercialization of our product candidates in countries outside the United
States and such collaborators’ ability to obtain regulatory and reimbursement approvals in such countries;
secure acceptance of our product candidates from physicians, healthcare payers, patients and the medical community; and
manage our spending as costs and expenses increase due to clinical trials, regulatory approvals and commercialization.
There are no guarantees that we will be successful in completing these tasks. If we are unable to successfully complete these tasks, we may
not be able to successfully commercialize FUROSCIX or any of our product candidates, if approved, in a timely manner, or at all, in which
case we may be unable to generate sufficient revenues to sustain and grow our business.
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.
In order to market products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements
on a country-by-country basis regarding safety and efficacy. Approval by the FDA in the United States does not ensure approval by
regulatory authorities in other countries or jurisdictions. In addition, the clinical standards of care may differ significantly such that clinical
trials conducted in one country may not be accepted by healthcare providers, third-party payers or regulatory authorities in other countries,
and regulatory approval in one country does not guarantee regulatory approval in any other country. Approval processes vary among
countries and can involve additional drug testing and validation and additional administrative review periods. Seeking foreign regulatory
approval could result in difficulties and costs for us and require additional preclinical studies or clinical trials which could be costly and time
consuming. Regulatory
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requirements can vary widely from country to country and could delay or prevent the introduction of our products in those countries. We do
not have any product candidates approved for sale in any jurisdiction, including in international markets, and we do not have experience in
obtaining regulatory approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain
and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our
ability to realize the full market potential of any drug we develop will be unrealized.
Risks Related to Clinical Development
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.
Before obtaining approval from regulatory authorities for the commercialization of any of our product candidates, we must conduct extensive
clinical trials to demonstrate the safety and efficacy of the product candidate in humans. Preclinical and clinical drug development is
expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the preclinical
study or clinical trial process. Despite promising preclinical or clinical results, any product candidate can unexpectedly fail at any stage of
preclinical or clinical development. The historical failure rate for product candidates in our industry is high.
The results from preclinical studies or early clinical trials of a product candidate may not predict the results of later clinical trials of the product
candidate, and interim results of a clinical trial are not necessarily indicative of final results. Product candidates in later stages of clinical trials
may fail to show the desired safety and efficacy characteristics despite having progressed through preclinical studies and initial clinical trials.
It is not uncommon to observe results in clinical trials that are unexpected based on preclinical studies and early clinical trials, and many
product candidates fail in clinical trials despite very promising early results. Moreover, preclinical and clinical data are often susceptible to
varying interpretations and analyses. A number of companies in the pharmaceutical and biotechnology industries have suffered significant
setbacks in clinical development even after achieving promising results in earlier studies.
Before we can initiate clinical trials for any product candidates, we must submit the results of preclinical studies to the FDA or comparable
foreign regulatory authorities along with other information, including information about product candidate chemistry, manufacturing and
controls and our proposed clinical trial protocol, as part of an Investigational New Drug Application, or IND, or similar regulatory submission.
The FDA or comparable foreign regulatory authorities may require us to conduct additional preclinical studies for any product candidate
before it allows us to initiate clinical trials under any IND or similar regulatory submission, which may lead to delays and increase the costs of
our preclinical development programs. Moreover, even if we commence clinical trials, issues may arise that could cause regulatory
authorities to suspend or terminate such clinical trials. Any such delays in the commencement or completion of our ongoing and planned
clinical trials for our product candidates could significantly affect our product development timelines and product development costs and harm
our financial position.
We do not know whether our planned clinical trials will begin on time or be completed on schedule, if at all. The commencement, data
readouts and completion of clinical trials can be delayed for a number of reasons, including delays related to:
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inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of
clinical trials;
Obtaining allowance or approval from regulatory authorities to commence a trial or reaching a consensus with regulatory
authorities on trial design;
the FDA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials;
any failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to extensive
negotiation and may vary significantly among different CROs and trial sites;
delays in identifying, recruiting and training suitable clinical investigators;
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obtaining approval from one or more institutional review boards, or IRBs, or ethics committees at clinical trial sites;
IRBs refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional
subjects, or withdrawing their approval of the trial;
changes or amendments to the clinical trial protocol;
clinical sites deviating from the trial protocol or dropping out of a trial;
failure by our CROs to perform in accordance with Good Clinical Practice, or GCP, requirements or applicable regulatory rules
and guidelines in other countries;
manufacturing sufficient quantities of our product candidates, or obtaining sufficient quantities of combination therapies for use
in clinical trials;
subjects failing to enroll or remain in our trials at the rate we expect, or failing to return for post-treatment follow-up, including
subjects failing to remain in our trials;
patients choosing an alternative product for the indications for which we are developing our product candidates, or participating
in competing clinical trials;
lack of adequate funding to continue a clinical trial, or costs being greater than we anticipate;
subjects experiencing severe or serious unexpected drug-related adverse effects;
occurrence of serious adverse events in trials of the same class of agents conducted by other companies that could be
considered similar to our product candidates;
selection of clinical endpoints that require prolonged periods of clinical observation or extended analysis of the resulting data;
transfer of manufacturing processes to larger-scale facilities operated by a contract manufacturing organization, or CMO, delays
or failure by our CMOs or us to make any necessary changes to such manufacturing process, or failure of our CMOs to produce
clinical trial materials in accordance with current Good Manufacturing Practice, or cGMP, regulations or other applicable
requirements; and
third parties being unwilling or unable to satisfy their contractual obligations to us in a timely manner.
In addition, disruptions caused by the COVID-19 pandemic may increase the likelihood that we encounter such difficulties or delays in
initiating, enrolling, conducting or completing our planned and ongoing clinical trials.
Clinical trials must be conducted in accordance with the FDA and other applicable regulatory authorities’ legal requirements, regulations and
guidelines, and remain subject to oversight by these governmental agencies and ethics committees or IRBs at the medical institutions where
such clinical trials are conducted. We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the
institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or comparable foreign
regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct
the clinical trial in accordance with regulatory requirements or applicable clinical trial protocols, adverse findings from inspections of clinical
trial sites by the FDA or comparable foreign regulatory authorities, unforeseen safety issues or adverse side effects, failure to demonstrate a
benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to
continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial
protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to regulators or to IRBs for
reexamination, which may impact the costs, timing or successful completion of a clinical trial.
Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive
compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to
the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial
relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The
FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site
and the utility of the clinical trial itself may be jeopardized. This could result in a delay
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in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may
ultimately lead to the denial of marketing approval of one or more of our product candidates.
In addition, many of the factors that cause, or lead to, the termination suspension of, or a delay in the commencement or completion of,
clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Any resulting delays to our clinical trials
could shorten any period during which we may have the exclusive right to commercialize our product candidates. In such cases, our
competitors may be able to bring products to market before we do, and the commercial viability of our product candidates could be
significantly reduced. Any of these occurrences may harm our business, financial condition and prospects.
In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials may change and additional government
regulations may be enacted. For instance, the regulatory landscape related to clinical trials in the EU, recently evolved. The EU Clinical Trials
Regulation, or CTR, which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022.
While the Clinical Trials Directive required a separate clinical trial application, or CTA, to be submitted in each member state, to both the
competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the
submission of a single application to all member states concerned. The CTR allows sponsors to make a single submission to both the
competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment
procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate
assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member
state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may
proceed. Clinical trials for which an application was submitted (i) prior to January 31, 2022 under the Clinical Trials Directive, or (ii) between
January 31, 2022 and January 31, 2023 and for which the sponsor has opted for the application of the Clinical Trials Directive remain
governed by said Directive until January 31, 2025. After this date, all clinical trials (including those which are ongoing) will become subject to
the provisions of the CTR. Compliance with the CTR requirements by us and our third-party service providers, such as CROs, may impact
our developments plans.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials,
our development plans may be impacted
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.
Patient enrollment is a significant factor in the timing of clinical trials, and the timing of our clinical trials depends, in part, on the speed at
which we can recruit patients to participate in our trials, as well as completion of required follow-up periods. We may not be able to initiate or
continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in
these trials to such trial’s conclusion as required by the FDA or other comparable regulatory authorities. The eligibility criteria of our clinical
trials, once established, may further limit the pool of available trial participants.
Patient enrollment for any of our clinical trials may be affected by other factors, including:
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size and nature of the targeted patient population;
severity of the disease or condition under investigation;
availability and efficacy of approved therapies for the disease or condition under investigation;
patient eligibility criteria for the trial in question as defined in the protocol;
perceived risks and benefits of the product candidate under study;
clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other
available therapies, including any products that may be approved for, or any product candidates under investigation for, the
indications we are investigating;
efforts to facilitate timely enrollment in clinical trials;
patient referral practices of physicians;
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the ability to monitor patients adequately during and after treatment;
proximity and availability of clinical trial sites for prospective patients;
continued enrollment of prospective patients by clinical trial sites;
the risk that patients enrolled in clinical trials will drop out of such trials before completion; and
delays or difficulties in enrollment and completion of studies due to the COVID-19 pandemic.
Additionally, other pharmaceutical companies targeting these same diseases are recruiting clinical trial patients from these patient
populations, which may make it more difficult to fully enroll our clinical trials. We also rely on, and will continue to rely on, CROs and clinical
trial sites to ensure proper and timely conduct of our clinical trials and preclinical studies. Though we have entered into agreements
governing their services, we will have limited influence over their actual performance. Our inability to enroll a sufficient number of patients for
our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment delays in
our clinical trials may result in increased development costs for our product candidates and jeopardize our ability to obtain regulatory
approval for the sale of our product candidates. Furthermore, even if we are able to enroll a sufficient number of patients for our clinical trials,
we may have difficulty maintaining enrollment of such patients in our clinical trials.
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.
Undesirable side effects that may be caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt
clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign
authorities. The most common adverse events observed in clinical trials of FUROSCIX included the following administration site and skin
reactions: erythema, bruising, edema and infusion site pain. Results of our trials could reveal a high and unacceptable severity and
prevalence of these or other side effects. It is possible that there may be side effects associated with our other product candidates’ use. In
such an event, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us to cease
further development of or deny approval of our product candidates for any or all targeted indications. The drug-related side effects could
affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Clinical trials by
their nature utilize a sample of the potential patient population. With a limited number of patients and limited duration of exposure, rare and
severe side effects of our product candidates may only be uncovered with a significantly larger number of patients exposed to the product
candidate.
If our product candidates receive marketing approval and we or others identify undesirable side effects caused by such products (or any
other similar products) after such approval, a number of potentially significant negative consequences could result, including:
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regulatory authorities may withdraw or limit their approval of such products;
regulatory authorities may require the addition of labeling statements, such as a Risk Evaluation or Mitigation Strategy, or
REMS, “boxed” warning or a contraindication;
we may be required to change the way such products are distributed or administered, conduct additional clinical trials or
change the labeling of the products;
we may be subject to regulatory investigations and government enforcement actions;
we may decide to recall or remove such products from the marketplace; or
we could be sued and held liable for injury caused to individuals exposed to or taking our product candidates; or
we may fail to secure acceptance of our product candidates from physicians, healthcare payers, patients and the medical
community; and
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our reputation may suffer.
We believe that any of these events could prevent us from achieving or maintaining market acceptance of the affected products, and could
substantially increase the costs of commercializing our products and significantly impact our ability to successfully commercialize our
products and generate revenues. Any of these occurrences may harm our business, financial condition and prospects.
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.
From time to time, we may publicly disclose interim, topline, or preliminary data from our clinical trials and preclinical studies, which is based
on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more
comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and
conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a
result, the interim, topline, or preliminary results that we report may differ from future results of the same studies or trials, or different
conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline and preliminary
data also remain subject to audit and verification procedures that may result in the final data being materially different from the topline or
preliminary data we previously published. As a result, topline and preliminary data should be viewed with caution until the final data are
available.
Interim data from clinical trials that we may complete are further subject to the risk that one or more of the clinical outcomes may materially
change as patient enrollment continues and more patient data become available. Adverse differences between interim, topline, or preliminary
data and final data could significantly harm our business prospects. Further, disclosure of such data by us or by our competitors could result
in volatility in the price of our common stock.
Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or
analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability
or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to
publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not
agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine
not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a
particular product candidate or our business. If the interim, topline, or preliminary data that we report differ from actual results, or if others,
including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product
candidates may be harmed, which could harm our business, operating results, prospects or financial condition
Our failure to successfully identify, develop and market additional product candidates could impair our ability to grow.
As part of our growth strategy, we intend to identify, develop and market additional products beyond FUROSCIX. We are exploring various
therapeutic opportunities for our pipeline and product programs for use with West's proprietary on-body infusor. We may spend several years
completing our development of any particular current or future internal product candidates, and failure can occur at any stage. The product
candidates to which we allocate our resources may not end up being successful. In addition, because our internal research capabilities are
limited, we may be dependent upon pharmaceutical companies, academic scientists and other researchers to sell or license product
candidates, approved products or the underlying technology to us. The success of this strategy depends partly upon our ability to identify,
select, discover and acquire promising product candidates and products.
The process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and
complex. Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for the
license or acquisition of product candidates and approved products. We have limited resources to identify and execute the acquisition or in-
licensing of third-party
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products, businesses and technologies and integrate them into our current infrastructure. Moreover, we may devote resources to potential
acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts. We may
not be able to acquire the rights to additional product candidates on terms that we find acceptable, or at all.
In addition, future acquisitions may entail numerous operational and financial risks, including:
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exposure to unknown liabilities;
disruption of our business and diversion of our management’s time and attention to develop acquired products or technologies;
incurrence of substantial debt, dilutive issuances of securities or depletion of cash to pay for acquisitions;
higher than expected acquisition and integration costs;
difficulty in combining the operations and personnel of any acquired businesses with our operations and personnel;
increased amortization expenses;
impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and
ownership; and
inability to motivate key employees of any acquired businesses.
Further, any product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive
clinical testing and approval by the FDA and other foreign regulatory authorities.
Risks Related to Acceptance, Sales, Marketing and Competition
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.
Even if our current and future product candidates are approved for commercialization by the appropriate regulatory authorities, physicians
may not prescribe our approved product candidates, in which case we would not generate the revenues we anticipate. Market acceptance of
FUROSCIX or any of our product candidates by physicians, patients, third-party payers and the medical community depends on, among
other things:
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our ability to provide acceptable evidence of safety and efficacy, at least equivalent to IV-level treatments;
perceived advantages of FUROSCIX or our product candidates over alternative treatments, such as oral and IV formulations;
relative convenience as well as ease of administration of FUROSCIX or our product candidates compared to existing
treatments;
any labeling restrictions placed upon FUROSCIX or any product candidate in connection with its approval;
the prevalence and severity of the adverse side effects of FUROSCIX or our product candidates;
the clinical indications for which FUROSCIX or any of our product candidates is approved, including any potential additional
restrictions placed upon each product candidate in connection with its approval;
prevalence of the disease or condition for which FUROSCIX or any product candidate is approved;
the cost of treatment in relation to alternative treatments, including generic products;
the extent to which each product is approved for use at, or included on formularies of, hospitals and managed care
organizations;
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any negative publicity related to our or our competitors’ products or other formulations of products that we administer
subcutaneously, including as a result of any related adverse side effects;
the effectiveness of our or any current or future collaborators’ sales, marketing and distribution strategies;
pricing and cost effectiveness; and
the availability of coverage and adequate reimbursement by third parties.
Successful commercialization will also depend on whether we can adequately protect against and effectively respond to any claims by
holders of patents and other intellectual property rights that our products infringe upon their rights, whether any unanticipated adverse effects
or unfavorable publicity develops in respect of our products, as well as the emergence of new or existing products as competition, which may
be proven to be more clinically effective and cost-effective.
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 any revenue.
We are in the process of establishing sufficient infrastructure for the sales, marketing or distribution of FUROSCIX and for our product
candidates, and the cost of establishing and maintaining such an organization may exceed the benefits of doing so. In order to market
FUROSCIX, we must continue to build our sales, marketing, managerial, and other non-technical capabilities or make arrangements with
third parties to perform these services.
We have established an initial sales force to promote FUROSCIX to hospital networks, healthcare providers and third-party payers in the
United States. There are significant expenses and risks involved with establishing our own sales and marketing capabilities, including our
ability to hire, retain and appropriately incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and
marketing personnel, and effectively manage a geographically dispersed sales and marketing team.
We cannot be sure that we will be able to hire a sufficient number of sales representatives or that they will be effective at promoting
FUROSCIX. In addition, we will need to commit significant additional management and other resources to establish and grow our sales
organization. We may not be able to achieve the necessary development and growth in a cost-effective manner or realize a positive return on
our investment. We will also have to compete with other companies to recruit, hire, train and retain sales and marketing personnel.
Factors that may inhibit our efforts to commercialize FUROSCIX and our product candidates, if approved, on our own include:
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our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
the inability of sales personnel to obtain access to physicians in order to educate physicians about our product candidates,
once approved; and
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
If we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, our
business, results of operations, financial condition and prospects will be materially adversely impacted.
Beyond FUROSCIX, we intend to leverage the sales and marketing capabilities that we establish for FUROSCIX to commercialize additional
product candidates, if approved by the FDA, in the United States. If we are unable to do so for any reason, we would need to expend
additional resources to establish commercialization capabilities for those product candidates, if approved.
In addition, we intend to establish collaborations to commercialize our product candidates, if approved by the relevant regulatory authorities,
outside of the United States. Therefore, our future success will depend, in part, on our ability to enter into and maintain collaborative
relationships for such efforts, the collaborator’s strategic interest in the product and such collaborator’s ability to successfully market and sell
the product. We cannot assure you
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that we will be able to establish or maintain such collaborative arrangements, or if able to do so, that they will have effective sales forces. To
the extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third
parties, and there can be no assurance that such efforts will be successful.
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.
We face and will continue to face competition from other companies in the pharmaceutical and medical device industries. We believe our
technology and approach of developing proprietary formulations of medicines to be delivered subcutaneously will compete with the efforts of
other companies seeking to develop similar therapies. These and other pharmaceutical companies are applying significant resources and
expertise to the challenges of drug delivery. Some of these current and potential future competitors may be addressing the same therapeutic
areas or indications as we are. Many of our current and potential future competitors have significantly greater research and development
capabilities than we do, have substantially more marketing, manufacturing, financial, technical, human and managerial resources than we do,
and have more institutional experience than we do.
As a result of these factors, our competitors may obtain regulatory approval of their products more rapidly than we are able to or may obtain
patent protection or other intellectual property rights that allow them to develop and commercialize their products before us and limit our
ability to develop or commercialize our product candidates. Our competitors may also develop drugs or devices that are more effective, more
widely used and less costly than ours, and they may also be more successful than us in manufacturing and marketing their products.
If the FDA approves a competitor’s application for a product candidate or drug-device combination product before our application for a similar
product candidate or drug-device combination product, and grants such competitor a period of exclusivity, the FDA may take the position that
it cannot approve our 505(b)(2) application for a similar product candidate until the exclusivity period expires. Additionally, even if our 505(b)
(2) application for any of our product candidates is approved first, we may still be subject to competition from other producers of heart failure
and infectious disease therapies with approved products or approved 505(b)(2) NDAs for different conditions of use that would not be
restricted by any grant of exclusivity to us.
The widespread acceptance of currently available therapies with which FUROSCIX and our product candidates will compete may limit market
acceptance of FUROSCIX and our product candidates even if commercialized. Oral medication and IV drug delivery are currently available
treatments for heart failure and are widely accepted in the medical community and have a long history of use. For example, the use of IV
furosemide to treat decompensation in heart failure patients is well-established and has received widespread market acceptance. These
treatments will compete with FUROSCIX and the established use of IV furosemide may limit the potential for FUROSCIX to receive
widespread acceptance.
Risks Related to the COVID-19 Pandemic
The ongoing and evolving COVID-19 pandemic may materially and adversely affect our business and our financial results,
including the activities supporting our commercial launch of FUROSCIX.
The ongoing and evolving COVID-19 pandemic may continue to have a negative impact on the global economy which could impact our
business and results of operations. The continued spread of COVID-19, and any current or new variants of the virus, could adversely impact
our operations. For instance, the COVID-19 pandemic may negatively affect the operations of third-party suppliers, which could result in
delays or disruptions in the supply of FUROSCIX and our product candidates. Furthermore, COVID-19 may delay enrollment in any future
clinical trials due to prioritization of hospital resources toward the pandemic and restrictions in travel. Some patients may be unwilling to
enroll in future clinical trials or be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or
interrupt healthcare services. In addition, any governmental measures that are implemented to control the spread of the virus, including
quarantines, travel restrictions and business shutdowns, could negatively affect our business. For instance, encouraging all employees to
work remotely may disrupt our operations or increase the risk of a cybersecurity incident. COVID-19 has also caused volatility in the global
financial markets and a slowdown in the global economy, which may negatively affect our ability to raise additional capital on attractive terms
or at all.
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The extent to which COVID-19 may impact our business will depend on future developments, which are highly uncertain and cannot be
predicted with confidence, such as the duration or potential resurgence of the pandemic, the severity of new variants of COVID-19 or the
effectiveness of actions to contain and treat COVID-19. To date, the third parties that perform our manufacturing, assembly, packaging and
testing of our products have experienced delays relating to supply chain logistics but have remained operational. An extended period of
global supply chain and economic disruption may continue to impact us and could materially affect our business, results of operations,
access to sources of liquidity and financial condition. We cannot presently predict the scope and severity of any potential business
shutdowns or disruptions. If we or any of the third parties with whom we engage, however, were to experience shutdowns or other business
disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively
affected, which could have a material adverse impact on our business and our 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.
The ability of the FDA and foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including
government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s or foreign regulatory authorities’ ability to hire and
retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory
authorities’ ability to perform routine functions. Average review times at the FDA and foreign regulatory authorities have fluctuated in recent
years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to
the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies, such as the EMA following its
relocation to Amsterdam and resulting staff changes, may also slow the time necessary for new drugs, medical devices and biologics or
modifications to approved drugs, and biologics to be reviewed and/or approved by necessary government agencies, which would adversely
affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory
agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.
Separately, in response to the global COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing
facilities at various points. Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the
FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the
firms it regulates as it adapts to the evolving COVID-19 pandemic, and any resurgence of the virus or emergence of new variants may lead to
further inspectional delays. Regulatory authorities outside the United States may adopt similar policy measures in response to the COVID-19
pandemic. If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory
authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA
or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our
business
Risks Related to Manufacturing, Supply and Use
If we fail to produce FUROSCIX in the volumes that we require on a timely basis, we may face delays in our commercialization
efforts.
We do not currently own or operate manufacturing facilities for the production of FUROSCIX or any of our product candidates. We currently
depend on third parties to manufacture our product candidates, including the drug formulation and device components for FUROSCIX, and
continue to rely on such third parties to produce the final commercial product. Any future curtailment in the availability of materials could
result in production or other delays with consequent adverse effects on us. In addition, because regulatory authorities must generally approve
raw material sources for pharmaceutical products, changes in raw material suppliers may result in production delays or higher raw material
costs.
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The manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced
manufacturing techniques and process controls. Pharmaceutical companies often encounter difficulties in production, particularly in scaling
up production, of their products. These problems include manufacturing difficulties relating to production costs and yields, quality control,
including stability of the product and quality assurance testing, shortages of qualified personnel, as well as compliance with federal, state and
foreign regulations. Any delays in the manufacturing of finished drug product or device components could delay our commercial supply,
which could delay, prevent or limit our ability to generate revenue and continue our business. Moreover, if we are unable to demonstrate
stability in accordance with commercial requirements, or if our manufacturers were to encounter difficulties or otherwise fail to comply with
their obligations to us, our ability to obtain FDA or foreign regulatory authorities approval and market our product candidates would be
jeopardized. In addition, any delay or interruption in the supply of clinical trial supplies could delay or prohibit the completion of our
bioequivalence and/or clinical trials, increase the costs associated with conducting our bioequivalence and/or clinical trials and, depending
upon the period of delay, require us to commence new trials at significant additional expense or to terminate a trial.
Manufacturers of drug-device combination products need to comply with both pharmaceutical current good manufacturing practice
requirements, or cGMPs, and the FDA’s cGMP requirements for medical devices, known as the Quality System Regulation, or QSR, which is
enforced by the FDA through its facilities inspection programs. These requirements include, among other things, quality control, quality
assurance and the maintenance of records and documentation. Manufacturers of FUROSCIX and our product candidates may be unable to
comply with these cGMP and QSR requirements and with other FDA and foreign regulatory requirements. For certain commercial
prescription drug products, manufacturers and other parties involved in the supply chain must also meet chain of distribution requirements
and build electronic, interoperable systems for product tracking and tracing and for notifying the FDA of counterfeit, diverted, stolen and
intentionally adulterated products or other products that are otherwise unfit for distribution in the United States. A failure to comply with these
requirements may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or
recall, or withdrawal of product approval. If the safety of FUROSCIX or any of our product candidates is compromised due to failure to adhere
to applicable laws or for other reasons, we may not be able to successfully commercialize FUROSCIX or such product candidate, and we
may be held liable for any injuries sustained as a result. Any of these factors could cause a delay in the commercialization of FUROSCIX or
our product candidates, entail higher costs or even prevent us from effectively commercializing FUROSCIX or our product candidates.
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.
While we believe FUROSCIX can be self-administered by patients, caregivers and healthcare practitioners in a clinic and home environment,
we cannot control the successful use of the product by patients, caregivers and healthcare professionals. We make use of packaging and
instructions for use to provide guidance to users of FUROSCIX, but we cannot ensure that the product will be used properly.
For example, in our Phase 3 product design clinical validation study, there were four cases in which the FUROSCIX administered doses fell
below the predefined criteria. One case was determined to be a dispensing failure, and the remaining three cases were determined to be
caused by an undetected incomplete filling of our first generation device, likely due to user errors. As a result, the study did not meet its
specified primary endpoints. If we are not successful in promoting the proper use of FUROSCIX by patients, healthcare professionals and
caregivers, we may not be able to achieve market acceptance or effectively commercialize FUROSCIX.
Even in the event of proper use of FUROSCIX by patients, healthcare professionals and caregivers, individual devices may fail.
We have increased manufacturing capabilities for production of FUROSCIX, but increasing scale of production inherently creates increased
risk of manufacturing errors. We may not be able to adequately inspect every device that is produced, and it is possible that individual
devices may fail to perform as designed. Manufacturing errors could negatively impact market acceptance of FUROSCIX, result in negative
press coverage, or increase the risk that we may be sued.
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Risks Related to Our Financial Position and Capital Requirements
Risks Related to Past Financial Condition
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 do not expect to generate revenue or profitability that is necessary to finance our operations in the short term. We incurred net losses of
$28.0 million and $36.8 million for the years ended December 31, 2021 and 2022, respectively. In addition, our accumulated deficit as of
December 31, 2022 was $226.5 million. Absent the realization of sufficient revenues from product sales, if any, of FUROSCIX or our current
or future product candidates, if approved, we may never attain profitability in the future. We have devoted substantially all of our financial
resources and efforts to date to research and development, including preclinical studies and our clinical trials, and preparation for
commercialization of FUROSCIX.
We anticipate that our expenses will increase substantially if and as we:
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build our sales, marketing, distribution and other commercial infrastructure and manufacture commercial inventory of
FUROSCIX;
initiate and continue research, preclinical and clinical development efforts for any current or future product candidates;
seek to identify additional product candidates;
seek regulatory and marketing approvals for product candidates that successfully complete clinical trials;
manufacture larger quantities of product candidates for clinical development and, potentially, commercialization;
maintain, expand and protect our intellectual property portfolio;
hire and retain additional personnel, such as clinical, quality control, commercial, scientific and sales and marketing personnel;
add operational, financial and management information systems and personnel, including personnel to support our product
development and help us comply with our obligations as a public company; and
add equipment and physical infrastructure to support our research and development.
Our ability to become and remain profitable depends on our ability to generate revenue. We do not expect to generate significant revenue
until we are able to successfully commercialize FUROSCIX or any other product candidates that we may develop. Successful
commercialization will require achievement of key milestones, including completing clinical trials of our product candidates that are under
clinical development, obtaining marketing approval for our product candidates, manufacturing, marketing and selling those products for which
we, or any of our future collaborators, may obtain marketing approval, satisfying any post-marketing requirements and obtaining
reimbursement for our products from private insurance or government payers. Because of the uncertainties and risks associated with these
activities, we are unable to accurately predict the timing and amount of revenues, and if or when we might achieve profitability. We and any
future collaborators may never succeed in these activities and, even if we or any future collaborators do, we may never generate revenues
that are large enough for us to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability
on a quarterly or annual basis.
Our failure to become and remain profitable would depress the market price of our common stock and could impair our ability to raise capital,
expand our business, diversify our product offerings or continue our operations. If we continue to suffer losses as we have in the past,
investors may not receive any return on their investment and may lose their entire investment.
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 commenced operations in 2013. Our operations to date have been limited to financing and staffing our company, developing our
technology and conducting preclinical research and clinical trials for our product
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candidates. We have not yet demonstrated an ability to manufacture a commercial-scale product, or arrange for a third party to do so on our
behalf, or conduct sales and marketing activities necessary for successful product commercialization.
We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business
objectives. We will need to transition from a company with a development focus to a company capable of supporting commercial activities.
We may not be successful in such a transition.
In addition, we expect our financial condition and operating results to continue to fluctuate significantly from quarter to quarter and year to
year due to a variety of factors, many of which are beyond our control.
We may not generate substantial revenue from FUROSCIX and may never be profitable.
Our ability to become profitable depends upon our ability to generate revenue. Our commercial launch of FUROSCIX commenced in the first
quarter of 2023, and there is no assurance that we will generate substantial revenues from FUROSCIX.
Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to:
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continue to obtain commercial quantities of FUROSCIX at acceptable cost levels;
obtain third-party coverage or adequate reimbursement for FUROSCIX;
achieve market acceptance of FUROSCIX in the medical community and with third-party payers, including placement in
accepted clinical guidelines for the conditions for which FUROSCIX is intended to target; and
delay the introduction by third parties of alternate versions of FUROSCIX.
We expect to incur significant sales and marketing costs as we commercialize FUROSCIX. Even if we expend these costs, FUROSCIX may
not be a commercially successful device-drug combination. We may not achieve profitability soon after generating product sales, if ever. If we
are unable to generate substantial product revenue, we will not become profitable and may be unable to continue operations without
continued funding.
Risks Related to Future Financial Condition
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.
Developing our product programs is a time-consuming, expensive and uncertain process that takes years to complete. In addition, we may
incur significant commercialization expenses for FUROSCIX or any of our product candidates, if approved, related to product sales,
marketing, manufacturing and distribution. Accordingly, we will need to obtain substantial additional funding in connection with our continuing
operations. If we are unable to raise capital when needed or on attractive terms, we may be forced to delay, reduce or eliminate our research
and development programs or any commercialization efforts.
We plan to continue to use our existing unrestricted cash primarily for development activities related to the advancement and
commercialization of FUROSCIX, automation necessary to increase capacity for our delivery technology, research and development, and for
working capital and other general corporate purposes. We will be required to expend significant funds in order to commercialize FUROSCIX,
as well as other product candidates we may seek to develop. In any event, our existing unrestricted cash may not be sufficient to fund all of
the efforts that we plan to undertake, including the development of any of our product candidates. Accordingly, we may be required to obtain
further funding through public or private equity offerings, debt financings, royalty-based financing arrangements, collaborations and licensing
arrangements or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise
capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. In
addition, we maintain our cash and cash equivalents at a number of financial institutions, and our deposits at one or more of these institutions
may exceed federally insured limits. Market conditions can impact the viability of one or more of these institutions and, in the event of failure
of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we will be able to
access uninsured funds in a timely manner or at all.
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Our future funding requirements, both short-term and long-term, will depend on many factors, including:
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the outcome, timing and costs of completing development and seeking regulatory approvals for product candidates that we
may develop;
the costs of commercialization activities for FUROSCIX and any of our product candidates that receive marketing approval,
including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;
revenue, if any, received from commercial sales of FUROSCIX or any of our current and future product candidates;
the pricing and reimbursement of FUROSCIX and of any of our product candidates that may be approved;
the number of future product candidates that we pursue and their development requirements;
the scope, progress, timing, costs and results of clinical trials of, and research and preclinical development efforts for, our other
product candidates;
our ability to enter into, and the terms and timing of, any collaborations, licensing or other arrangements;
our headcount growth and associated costs as we establish a commercial infrastructure and continue our research and
development activities;
the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights
including enforcing and defending intellectual property related claims;
costs associated with any adverse market conditions or other macroeconomic factors; and
the costs of operating as a public company.
The terms of our credit 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.
In October 2022, we entered into a Credit Agreement and Guaranty, or the Credit Agreement, with, among others, funds managed by
Oaktree Capital Management, L.P., or Oaktree. The Credit Agreement establishes a $100.0 million term loan facility, consisting of (i) $50.0
million, or the Tranche A Loan, funded at closing, (ii) $25.0 million, or the Tranche B Loan, that we may borrow in up to two draws on or prior
to September 30, 2024, and (iii) $25.0 million, or the Tranche C Loan, that we may borrow on or prior to December 31, 2024; provided, in the
case of the Tranche B Loan and the Tranche C Loan, that we have achieved certain net sales revenue milestone targets described in the
Credit Agreement. We used a portion of the proceeds from the Tranche A Loan to prepay all outstanding loans under our prior loan and
security agreement with SLR Investment Corp. (f/k/a Solar Capital Ltd.) and Silicon Valley Bank. All obligations under our secured credit
facility are secured by substantially all of our existing property and assets (including our intellectual property assets), subject to certain
exceptions. This debt financing may create additional financial risk for us, particularly if our business or prevailing financial market conditions
are not conducive to paying off or refinancing our outstanding debt obligations at maturity.
The Credit Agreement contains customary representations, warranties and affirmative and negative covenants, including financial covenants
requiring us to (i) maintain certain levels of cash and cash equivalents in accounts subject to a control agreement in favor of Oaktree of at
least $15.0 million at all times commencing from November 13, 2022 and increasing to $20.0 million of cash and cash equivalents in such
controlled accounts after we borrow the Tranche B Loan, and (ii) meet minimum quarterly net sales revenue targets described in the Credit
Agreement. In addition, the Credit Agreement contains customary events of default that entitle Oaktree to accelerate our indebtedness under
the Credit Agreement to become immediately due and payable. Under the Credit Agreement, an event of default will occur if, among other
things, we fail to make payments under the Credit Agreement (subject to specified periods), we or our subsidiaries breach any of the
covenants under the Credit Agreement (subject to specified cure periods with respect to certain breaches), a material adverse change
occurs, we, our subsidiaries or our respective assets become subject to certain legal proceedings, such as bankruptcy proceedings, we
and/or our subsidiaries are unable to pay our debts as they become due or default on contracts with third parties which would permit the
holder of indebtedness in excess of a certain threshold to accelerate the maturity of such indebtedness or that could cause a material
adverse change..
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Failure to satisfy our current and future debt obligations, including covenants to take or avoid specific actions, under our secured credit facility
could result in an event of default and, as a result, our lenders could accelerate all of the amounts due. In the event of an acceleration of
amounts due under our secured credit facility as a result of an event of default, we may not have sufficient funds or may be unable to arrange
for additional financing to repay our indebtedness while still pursuing our current business strategy. In addition, our lenders could seek to
enforce their security interests in any collateral securing such indebtedness.
Risks Related to Government Regulation
Risks Related to Ongoing Regulatory Obligations
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.
The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution
of our products and product candidates are subject to extensive regulation by the FDA in the U.S. and by comparable foreign regulatory
authorities in foreign markets. In the U.S., we are not permitted to market our product candidates in the U.S. until we receive regulatory
approval of an NDA from the FDA. The process of obtaining such regulatory approval is expensive, often takes many years following the
commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved,
as well as the target indications and patient population. Approval policies or regulations may change, and the FDA and comparable
regulatory have substantial discretion in the approval process, including the ability to delay, limit or deny approval of a product candidate for
many reasons. Despite the time and expense invested in clinical development of product candidates, regulatory approval of a product
candidate is never guaranteed. Of the large number of drugs in development, only a small percentage successfully complete the FDA or
foreign regulatory approval processes and are commercialized.
Prior to obtaining approval to commercialize a product candidate in the U.S. or abroad, we must demonstrate with substantial evidence from
adequate and well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product
candidates are safe and effective for their intended uses. Results from nonclinical studies and clinical trials can be interpreted in different
ways. Even if we believe available nonclinical or clinical data support the safety or efficacy of our product candidates, such data may not be
sufficient to obtain approval from the FDA and comparable foreign regulatory authorities. The FDA or comparable foreign regulatory
authorities, as the case may be, may also require us to conduct additional preclinical studies or clinical trials for our product candidates either
prior to or post-approval, or may object to elements of our clinical development program.
The FDA or comparable foreign regulatory authorities can delay, limit or deny approval of a product candidate for many reasons, including:
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such authorities may disagree with the design or execution of our clinical trials;
negative or ambiguous results from our clinical trials or results may not meet the level of statistical significance required by the
FDA or comparable foreign regulatory agencies for approval;
serious and unexpected drug-related side effects may be experienced by participants in our clinical trials or by individuals using
drugs similar to our product candidates;
the population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full population for
which we seek approval;
such authorities may not accept clinical data from trials that are conducted at clinical facilities or in countries where the standard
of care is potentially different from that of their own country;
we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
such authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
such authorities may not agree that the data collected from clinical trials of our product candidates are acceptable or sufficient to
support the submission of an NDA or other submission or to obtain
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regulatory approval in the U.S. or elsewhere, and such authorities may impose requirements for additional preclinical studies or
clinical trials;
such authorities may disagree with us regarding the formulation, labeling and/or the product specifications of our product
candidates;
approval may be granted only for indications that are significantly more limited than those sought by us, and/or may include
significant restrictions on distribution and use;
such authorities may find deficiencies in the manufacturing processes or facilities of the third-party manufacturers with which we
contract for clinical and commercial supplies; or
such authorities may not accept a submission due to, among other reasons, the content or formatting of the submission.
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With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional
product testing, administrative review periods and agreements with pricing authorities.
Additionally, the FDA regulates FUROSCIX as a combination product that consists of both a drug and a medical device, and we may develop
product candidates that are similarly regulated as combination products. Developing and obtaining regulatory approval for combination
products can pose unique challenges because they involve components that are regulated under different types of regulatory requirements
and potentially by different FDA centers. As a result, such product candidates may raise regulatory, policy and review management
challenges. Differences in regulatory pathways for each component of a combination product can impact the regulatory processes for all
aspects of product development and management, including clinical investigation, marketing applications, manufacturing and quality control,
adverse event reporting, promotion and advertising, user fees and post approval modifications. Although the FDA and similar foreign
regulatory agencies have systems in place for the review and approval of combination products such as ours, we may experience delays in
the development and commercialization of our product candidates due to regulatory timing constraints and uncertainties in the product
development and approval process.
Even if we eventually complete clinical trials and receive approval of a NDA or comparable foreign marketing application for any of our
product candidates, the FDA or comparable foreign regulatory authority may grant approval contingent on the performance of costly
additional clinical trials and/or the implementation of a REMS, which may be required because the FDA believes it is necessary to ensure
safe use of the product after approval. Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent
commercialization of that product candidate and would materially adversely impact our business and prospects
Even though FDA has approved FUROSCIX, we will remain subject to significant post-marketing regulatory requirements and
oversight.
In October 2022, the FDA approved FUROSCIX for the treatment of congestion due to fluid overload in adults with NYHA Class II/III chronic
heart failure. In connection with this approval, or any other approvals we may obtain for any of our product candidates, we are required to
submit reports to regulatory authorities and surveillance to monitor the safety and efficacy of the product. In addition, approved labeling for
our products may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or
contraindications, and may include burdensome post-approval study or risk management requirements. For example, the approved labeling
for FUROSCIX includes contraindications for patients with anuria, hypersensitivity to furosemide and hepatic cirrhosis or ascites, and is not
approved for use in emergency situations or in patients with acute pulmonary edema. The FDA may also require a REMS in order to approve
a product candidate, which could entail requirements for a medication guide, physician training and communication plans or additional
elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
In addition, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import,
export and recordkeeping for our products are subject to extensive and ongoing regulatory requirements. These requirements include
submissions of safety and other post-marketing information and reports, registration, as well as on-going compliance with current good
manufacturing practices, or cGMPs, and GCPs for any clinical trials that we conduct post-approval. In addition, manufacturers of drug
products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory
authorities for compliance with cGMP regulations and standards. If we or a regulatory authority
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discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the
facilities where the product is manufactured, a regulatory authority may impose restrictions on that product, the manufacturing facility or us,
including requiring recall or withdrawal of the product from the market or suspension of manufacturing.
In addition, failure to comply with FDA and other comparable foreign regulatory requirements may subject our company to administrative or
judicially imposed sanctions, including:
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delays in or the rejection of product approvals;
restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;
restrictions on the products, manufacturers or manufacturing process;
• warning or untitled letters;
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civil and criminal penalties;
injunctions;
suspension or withdrawal of regulatory approvals;
product seizures, detentions or import bans;
voluntary or mandatory product recalls and publicity requirements;
total or partial suspension of production; and
imposition of restrictions on operations, including costly new manufacturing requirements.
The occurrence of any event or penalty described above may inhibit our ability to commercialize FUROSCIX and generate revenue and
could require us to expend significant time and resources in response and could generate negative publicity. In addition, the FDA’s and other
regulatory authorities’ policies may change, and additional government regulations may be enacted that could impair our business. If we are
slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain
regulatory compliance, we may be subject to enforcement action, and we may not achieve or sustain profitability.
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.
Successful sales of FUROSCIX and any product candidates that receive regulatory approval depend on the availability of adequate coverage
and reimbursement rates from third-party payers, including governmental healthcare programs, such as Medicare and Medicaid, commercial
payers, and health maintenance organizations. Patients who are prescribed medications for the treatment of their conditions generally rely on
third-party payers to reimburse all or part of the costs associated with their prescription drugs. Coverage and adequate reimbursement rates
from governmental healthcare programs and commercial payers is critical to new product acceptance. Coverage decisions may depend upon
clinical and economic standards that disfavor new products when more established or lower cost therapeutic alternatives are already
available or subsequently become available. Even if we obtain coverage for a given product, the resulting reimbursement rates might not be
sufficient to achieve or sustain profitability or may require co-payments that patients find unacceptably high, thereby discouraging their use of
our products. Additionally, third-party payers may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required
following the use of our product candidates. Patients are unlikely to use our products unless coverage is provided and reimbursement is
adequate to cover a significant portion of the cost of our products.
In addition, the market for FUROSCIX and any product candidates that we attempt to commercialize will depend significantly on access to
third-party payers’ drug formularies, or lists of medications for which third-party payers provide coverage. The industry competition to be
included in such formularies often leads to downward pricing
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pressures on pharmaceutical companies. Also, third-party payers may refuse to include a particular branded drug in their formularies, or may
apply formulary controls (e.g., prior authorization or step therapy requirements, higher co-payments) to restrict patient access to a branded
drug when a less costly generic equivalent or other alternative is available.
Third-party payers, whether foreign or domestic, and whether governmental or commercial, are developing increasingly sophisticated
methods of controlling healthcare costs. In the United States, no uniform policy for coverage and reimbursement of products exists among
third-party payers. The Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human
Services, or HHS, decides whether and to what extent products will be covered and reimbursed under Medicare. Third-party payers often
rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. Reimbursement by a
third-party payer may depend upon a number of factors, including the third-party payer’s determination that a medication is safe, effective
and medically necessary; appropriate for the specific patient; cost-effective; supported by peer-reviewed medical journals; included in clinical
practice guidelines; and neither cosmetic, experimental nor investigational. Therefore, coverage of and reimbursement rates for products can
differ significantly from payer to payer. As a result, the coverage determination process is often a time-consuming and costly process that will
require us to provide scientific, clinical, and cost-effectiveness data for the use of our products to each payer separately, with no assurance
that coverage will be applied consistently or obtained in the first instance.
There may also be delays in obtaining coverage for newly approved drugs, and coverage may be more limited than the indications for which
the drug is approved by the FDA or comparable foreign regulatory authorities. Moreover, eligibility for reimbursement does not imply that any
drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution.
Reimbursement rates may vary, for example, according to the use of the product and the clinical setting in which it is used. Reimbursement
rates may also be based on reimbursement levels already set for lower cost drugs or may be incorporated into existing payments for other
services. We may also increasingly be required to provide discounts on our products to governmental healthcare programs, commercial
payers and health maintenance organizations.
Further, we believe that future coverage and reimbursement rates will likely be subject to increased restrictions both in the United States and
in international markets. Third-party coverage for our product candidates for which we may receive regulatory approval may not be available
or adequate in either the United States or international markets, which could have a material adverse effect on our business, results of
operations, financial condition and prospects.
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.
In October 2022, the FDA approved our NDA for FUROSCIX through the Section 505(b)(2) regulatory pathway, and we plan to develop
additional product candidates for which we plan to seek approval under the 505(b)(2) regulatory pathway, The Drug Price Competition and
Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, added Section 505(b)(2) to the FDCA. Section 505(b)(2)
permits the submissions of an NDA where at least some of the information required for approval comes from studies that were not conducted
by or for the applicant and for which the applicant has not obtained a right of reference. Section 505(b)(2), if applicable to us under the
FDCA, would allow an NDA we submit to the FDA to rely in part on data in the public domain or the FDA’s prior conclusions regarding the
safety and effectiveness of approved compounds, which could expedite the development program for our future product candidates by
potentially decreasing the amount of nonclinical and/or clinical data that we would need to generate in order to obtain FDA approval.
If the FDA does not allow us to pursue the Section 505(b)(2) regulatory pathway for our product candidates, we may need to conduct
additional nonclinical studies and/or clinical trials, provide additional data and information, and meet additional standards for regulatory
approval. If this were to occur, the time and financial resources required to obtain FDA approval for such product candidates, and
complications and risks associated with such product candidates, would likely substantially increase. Moreover, inability to pursue the Section
505(b)(2) regulatory pathway could result in new competitive products reaching the market more quickly than any product candidates we
developed, which could adversely impact our competitive position and prospects. Even if we are
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allowed to pursue the Section 505(b)(2) regulatory pathway, we cannot assure you that any product candidates we develop will receive the
requisite approval for commercialization.
In addition, notwithstanding the approval of a number of products by the FDA under Section 505(b)(2), certain pharmaceutical companies
and others have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA’s interpretation of Section 505(b)(2) is successfully
challenged, the FDA may change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA
that we submit under Section 505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are
subject to certain requirements designed to protect the patent rights of sponsors of previously approved drugs that are referenced in a
Section 505(b)(2) NDA. These requirements may give rise to patent litigation and mandatory delays in approval of our NDAs for up to 30
months or longer depending on the outcome of any litigation. It is not uncommon for a manufacturer of an approved product to file a citizen
petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If
successful, such petitions can significantly delay, or even prevent, the approval of a new product. Even if the FDA ultimately denies such a
petition, the FDA may substantially delay approval while it considers and responds to the petition. In addition, even if we are able to utilize the
Section 505(b)(2) regulatory pathway, there is no guarantee this would ultimately lead to streamlined product development or earlier
approval.
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.
Once an NDA, including a Section 505(b)(2) application, is approved, the product covered becomes a “listed drug” which can be cited by
potential competitors in support of approval of an abbreviated new drug application, or ANDA. FDA regulations and other foreign regulations
and policies provide incentives to manufacturers to create modified versions of a drug to facilitate the approval of an ANDA or other
application for similar substitutes. If these manufacturers demonstrate that their product has the same active ingredient(s), dosage form,
strength, route of administration, and conditions of use, or labeling, as FUROSCIX or any of our product candidates, they might only be
required to conduct a relatively inexpensive study to show that their generic product is absorbed in the body at the same rate and to the
same extent as, or is bioequivalent to, FUROSCIX or our product candidate (and in some cases even this limited bioequivalence testing can
be waived by the FDA). Competition from generic equivalents to FUROSCIX or any of our product candidates could substantially limit our
ability to generate revenues and therefore to obtain a return on the investments we have made in FUROSCIX and our product candidates.
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 are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the
handling, use, storage, treatment and disposal of hazardous materials and wastes. From time to time and in the future, our operations may
involve the use of hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste
products. Even if we contract with third parties for the disposal of these materials and waste products, we cannot completely eliminate the
risk of contamination or injury resulting from these materials. In the event of contamination or injury resulting from the use or disposal of our
hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur
significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.
We maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting
from the use of hazardous materials, but this insurance may not provide adequate coverage against potential liabilities. However, we do not
maintain insurance for environmental liability or toxic tort claims that may be asserted against us.
In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.
Current or future environmental laws and regulations may impair our research, development or production efforts. In addition, failure to
comply with these laws and regulations may result in substantial fines, penalties or other sanctions.
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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.
Any name we intend to use for our product candidates will require approval from the FDA regardless of whether we have secured a
trademark registration from the U.S. Patent and Trademark Office, or USPTO. The FDA typically conducts a review of proposed product
names, including an evaluation of potential for confusion with other product names. The FDA may object to any product name we submit if it
believes the name inappropriately implies medical claims. If the FDA objects to any of our proposed product names, we may be required to
adopt an alternative name for our product candidates. If we adopt an alternative name, we would lose the benefit of any existing trademark
applications for such product candidate, and may be required to expend significant additional resources in an effort to identify a suitable
product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the
FDA. We may be unable to build a successful brand identity for a new trademark in a timely manner or at all, which would limit our ability to
commercialize our product candidates.
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.
If we expand our operations outside of the United States, we must dedicate additional resources to comply with numerous laws and
regulations in each jurisdiction in which we plan to operate. The Foreign Corrupt Practices Act, or FCPA, prohibits offering, promising, giving,
or authorizing others to give anything of value, either directly or indirectly, to a non-United States government official in order to influence
official action, or otherwise obtain or retain business. The FCPA also obligates companies whose securities are listed in the United States to
comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all
transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting
controls for international operations.
Our business is heavily regulated and therefore involves significant interaction with public officials, which may in the future include officials of
non-United States governments. Additionally, in many other countries, the healthcare providers who prescribe pharmaceuticals are employed
by their government, and the purchasers of pharmaceuticals are government entities; therefore, our dealings with these prescribers and
purchasers would be subject to regulation under the FCPA. Recently the Securities and Exchange Commission, or SEC, and Department of
Justice have increased their FCPA enforcement activities with respect to biotechnology and pharmaceutical companies. There is no certainty
that all of our employees, agents, suppliers, manufacturers, contractors, or collaborators, or those of our affiliates, will comply with all
applicable laws and regulations, particularly given the high level of complexity of these laws.
Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with
certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to
those products. If we expand our presence outside of the United States, it will require us to dedicate additional resources to comply with
these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside of
the United States, which could limit our growth potential and increase our development costs.
The failure to comply with anti-bribery and anti-corruption laws, and other laws governing international business practices, may result in
substantial fines, criminal sanctions against us, our officers, or our employees, the closing down of facilities, including those of our suppliers
and manufacturers, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of
heightened monitoring by governmental authorities, and prohibitions on the conduct of our business. The SEC also may suspend or bar
issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.
Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
In some countries, such as the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental
control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing
approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement
levels, including as part of cost
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containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing
negotiations may continue after coverage and reimbursement have been obtained. Reference pricing used by various countries and parallel
distribution or arbitrage between low-priced and high-priced countries, can further reduce prices. To obtain reimbursement or pricing approval
in some countries, we, or any future collaborators, may be required to conduct a clinical trial that compares the cost-effectiveness of our
product candidates to other available therapies, which is time-consuming and costly. If reimbursement of our product candidates is
unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed.
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.
The FDA strictly regulates marketing, labeling, advertising and promotion of prescription drugs. These regulations include standards and
restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving the
internet and off-label promotion. Any regulatory approval that the FDA grants is limited to those specific diseases and indications for which a
product is deemed to be safe and effective by the FDA. For example, the FDA-approved label for FUROSCIX is limited to the treatment of
congestion due to fluid overload in adults with NYHA Class II/III chronic heart failure, and includes limitations prohibiting use in emergency
situations or patients with pulmonary edema.
Our promotional materials and training methods must comply with the FDA and other applicable laws and regulations, including laws and
regulations prohibiting marketing claims that promote the off-label use of our products or that omit material facts or make false or misleading
statements about the safety or efficacy of our products. Healthcare providers may use our products, if approved, off-label, as the FDA does
not restrict or regulate a physician’s choice of treatment within the practice of medicine. The FDA also could conclude that a claim is
misleading if it determines that there are inadequate nonclinical and/or clinical data supporting the claim, or if a claim fails to reveal material
facts about the safety or efficacy of our products. If the FDA determines that our promotional labeling or advertising materials promote an off-
label use or make false or misleading claims, it could request that we modify our promotional materials or training content or subject us to
regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fines and criminal
penalties.
It is also possible that other federal, state or foreign enforcement authorities might take action if they determine that our promotional or
training materials promote an unapproved use or make false or misleading claims, which could result in significant fines or penalties. The
FDA or another regulatory agency could disagree with the manner in which we advertise and promote our products. Violations of the FDCA
may also lead to investigations alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection
laws, which may lead to costly penalties and may adversely impact our business. Recent court decisions have impacted FDA’s enforcement
activity regarding off-label promotion in light of First Amendment considerations; however, there are still significant risks in this area, in part
due to the potential for False Claims Act exposure. In addition, the off-label use of our products may increase the risk of product liability
claims. Product liability claims are expensive to defend and could result in substantial damage awards against us and harm our reputation.
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.
In the United States and many foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes
regarding the healthcare system that could prevent or delay marketing approval of any of our product candidates, restrict or regulate post-
approval activities and affect our ability to profitably sell FUROSCIX or any product candidates for which we obtain marketing approval.
Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example:
(i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our
products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation
of our business.
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Among policy makers and payers in the United States and elsewhere, there is significant interest in promoting changes in healthcare
systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the
pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. The
Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, collectively referred to
as the ACA, is a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending,
enhance remedies against fraud and abuse, add new transparency requirements for the healthcare and health insurance industries, impose
new taxes and fees on the health industry and impose additional health policy reforms.
Among the provisions of the ACA of importance to our products and product candidates are the following:
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an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic
agents, apportioned among these entities according to their market share in certain government healthcare programs;
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for
certain drugs and biologics that are inhaled, infused, instilled, implanted or injected;
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1%
and 13.0% of the average manufacturer price for branded and generic drugs, respectively;
expansion of potential liability under federal healthcare fraud and abuse laws, including the False Claims Act, or FCA, and the
Anti-Kickback Statute, or AKS;
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (70% as of January
1, 2019 due to the Bipartisan Budget Act of 2018, or the BBA) point-of-sale discounts off negotiated prices of applicable brand
drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be
covered under Medicare Part D;
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid
managed care organizations;
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to
additional individuals, thereby potentially increasing manufacturers’ Medicaid rebate liability;
expansion of the entities eligible for discounts under the 340B drug pricing program;
new requirements to annually report to CMS certain data on payments and other transfers of value to physicians and teaching
hospitals;
a requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical
effectiveness research, along with funding for such research.
There have been a number of significant changes to the ACA and its implementation, as well as judicial, executive and Congressional
challenges to certain aspects of the ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the
ACA brought by several states without specifically ruling on the constitutionality of the ACA. Prior to the Supreme Court’s decision, President
Biden issued an executive order to initiate a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of
obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to
review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid
demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining
access to health insurance coverage through Medicaid or the ACA.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate
reductions to Medicare payments to providers pursuant to the Budget Control Act of
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2011, which began in 2013, and due to subsequent legislative amendments to the statute, will remain in effect through 2032, with the
exception of a temporary suspension from May 1, 2020 through March 31, 2022 due to the COVID-19 pandemic. The American Taxpayer
Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals and cancer treatment
centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
These laws and similar future initiatives may result in additional reductions in Medicare and other healthcare funding, which could have an
adverse effect on customers for FUROSCIX or our product candidates, if approved, and, accordingly, our financial operations.
There also has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices.
Specifically, there have been several recent U.S. Congressional inquiries and proposed federal and state legislation designed to, among
other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between
pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. In March 2021, the
American Rescue Plan Act of 2021 was signed into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a
drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024. In August 2022, the
Inflation Reduction Act of 2022, or IRA, was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage
in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare
Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap
discount program with a new discounting program (beginning in 2025). The IRA permits the Secretary of the Department of Health and
Human Services to implement many of these provisions through guidance, as opposed to regulation, for the initial years. For that and other
reasons, it is currently unclear how the IRA will be effectuated, or the impact of the IRA on our business.
In addition, there have been several changes to the 340B drug pricing program, which imposes ceilings on prices that drug manufacturers
can charge for medications sold to certain health care facilities. For the 2018 and 2019 fiscal years, CMS altered the reimbursement formula
from Average Sale Price, or ASP, plus 6 percent to ASP minus 22.5 percent on specified covered outpatient drugs, or SCODs, but did so
without issuing a formal notice of proposed rulemaking, which was subsequently challenged in court. In June 2022, the U.S. Supreme Court
held that although the Department of Health and Human Services, or HHS, has authority to set reimbursement rates based on average price
and discretion to “adjust” the price up or down, HHS may not vary the reimbursement rates by hospital group unless it conducts a survey of
hospitals’ acquisition costs. Accordingly, the U.S. Supreme Court held that HHS’s changes to the 2018 and 2019 reimbursement rates for
340B hospitals were unlawful. Based on the foregoing, CMS issued a final rule, effective January 1, 2023, pursuant to which CMS will pay
340B hospitals under Medicare Part B for certain outpatient drugs at the drug’s ASP, plus 6%, the same rate used for non-340B hospitals. It
is unclear how future changes to the payment methodology may affect pharmaceutical manufacturers and hospitals who purchase their
products now and in the future.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and
biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and
marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk
purchasing.
We expect that other healthcare reform measures may be adopted in the future, result in additional reductions in Medicare and other
healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we
receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar
reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us
from being able to generate revenue, attain profitability, or commercialize our products.
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.
Healthcare providers, including physicians, and third-party payers will play a primary role in the recommendation and prescription of any
products for which we obtain marketing approval. Our future arrangements with principal investigators, healthcare professionals, consultants,
third-party payers and customers, if any, will subject us to
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broadly applicable fraud and abuse and other healthcare laws and regulations. These laws and regulations may constrain the business or
financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute
any products for which we obtain marketing approval. The laws that will affect our operations include, but are not limited to, the following:
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the federal Anti-Kickback Statute, which makes it illegal for any person, including a prescription drug manufacturer (or a party
acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the
referral of business, including the purchase, order or prescription of a particular drug for which payment may be made under a
federal healthcare program, such as Medicare or Medicaid. A person or entity does not need to have actual knowledge of this
statute or specific intent to violate it to have committed a violation;
False claims laws, which prohibit anyone from knowingly and willfully presenting or causing to be presented for payment to third-
party payers, including government payers, claims for reimbursed drugs or services that are false or fraudulent, claims for items
or services that were not provided as claimed, or claims for medically unnecessary items or services. Cases have been brought
under false claims laws alleging that off-label promotion of pharmaceutical products or the provision of kickbacks has resulted in
the submission of false claims to governmental healthcare programs. In addition, the government may assert that a claim,
including items or services resulting from a violation of the federal Anti-Kickback Statute, constitutes a false or fraudulent claim
for purposes of the false claims laws. Further, private individuals have the ability to bring actions on behalf of the government
under the federal False Claims Act;
the Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits persons or entities from knowingly
and willfully executing a scheme to defraud any healthcare benefit program, including private payers, or knowingly and willfully
falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in
connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti- Kickback
Statute, a person or entity does not need to have actual knowledge of these statutes or specific intent to violate them to have
committed a violation;
federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer of remuneration to
a Medicare or state healthcare program beneficiary if the person knows, or should know, it is likely to influence the beneficiary’s
selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program,
unless an exception applies;
federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that
potentially harm consumers;
the federal physician sunshine requirements under ACA, which requires certain manufacturers of drugs, devices, biologics, and
medical supplies to report annually to the U.S. Centers for Medicare & Medicaid Services information related to payments and
other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain
non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse
anesthetists, anesthesiologist assistants, and certified nurse midwives), and teaching hospitals, and ownership and investment
interests held by physicians and their immediate family members;
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items
or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical
companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance
guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and
other potential referral sources; and state laws that require drug manufacturers to report information related to payments and
other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; and
European and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and
payments to healthcare providers.
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Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that
our business practices, including our arrangements with physicians and other healthcare providers, some of whom received stock options as
compensation for services provided, may be subject to challenge under current or future statutes, regulations, agency guidance or case law
involving applicable fraud and abuse or other healthcare laws and regulations. Law enforcement authorities are increasingly focused on
enforcing fraud and abuse laws, and it is possible that some of our practices may be challenged under these laws. Efforts to ensure that our
business arrangements with third parties, and our business generally, will comply with applicable healthcare laws and regulations will involve
substantial costs. The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully
interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. If our operations are found
to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil,
criminal and administrative penalties, damages, fines, individual imprisonment, exclusion from government funded healthcare programs,
such as Medicare and Medicaid, disgorgement, additional reporting requirements and oversight if we become subject to a corporate integrity
agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, diminished profits and future
earnings, reputational harm, and the curtailment or restructuring of our operations. Defending against any such actions can be costly, time-
consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such
actions that may be brought against us, our business may be impaired. Further, if any of the physicians or other healthcare providers or
entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or
administrative sanctions, including exclusions from government funded healthcare programs.
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.
The global data protection landscape is rapidly evolving, and we are or may become subject to numerous state, federal and foreign laws,
requirements and regulations governing the collection, use, disclosure, retention, and security of personal information. Implementation
standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future
laws, regulations, standards, or perception of their requirements may have on our business. This evolution may create uncertainty in our
business, affect our ability to operate in certain jurisdictions or to collect, store, transfer use and share personal information, necessitate the
acceptance of more onerous obligations in our contracts, result in liability or impose additional costs on us. Any failure or perceived failure by
us to comply with federal, state or foreign laws or regulations, our internal policies and procedures or our contracts governing our processing
of personal information could result in negative publicity, government investigations and enforcement actions, claims by third parties and
damage to our reputation, any of which could have a material adverse effect on our business, results of operation, and financial condition.
In the U.S., the Health Insurance Portability and Accountability Act, as amended by the Health Information Technology for Economic and
Clinical Health Act of 2009, and regulations implemented thereunder, or collectively HIPAA, imposes privacy, security and breach notification
obligations on certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as their business
associates that perform certain services that involve creating, receiving, maintaining or transmitting individually identifiable health information
for or on behalf of such covered entities, and their covered subcontractors. Most healthcare providers, including research institutions from
which we obtain patient health information, are subject to privacy and security regulations promulgated under HIPAA. While we do not
believe that we are currently acting as a covered entity or business associate under HIPAA and thus are not directly regulated under HIPAA,
any person may be prosecuted under HIPAA’s criminal provisions either directly or under aiding-and-abetting or conspiracy principles.
Consequently, depending on the facts and circumstances, we could face substantial criminal penalties if we knowingly receive individually
identifiable health information from a HIPAA-covered healthcare provider or research institution that has not satisfied HIPAA’s requirements
for disclosure of individually identifiable health information.
Certain states have also adopted comparable privacy and security laws and regulations, which govern the privacy, processing and protection
of health-related and other personal information. Such laws and regulations will be subject to interpretation by various courts and other
governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. For
example, the California
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Consumer Privacy Act of 2018, or CCPA went into effect on January 1, 2020. The CCPA creates individual privacy rights for California
consumers and increases the privacy and security obligations of entities handling certain personal information. The CCPA provides for civil
penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. Further, the
California Privacy Rights Act, or CPRA, passed in California, and it significantly amends the CCPA. It imposes additional data protection
obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for
higher risk data, and opt outs for certain uses of sensitive data. It also creates a new California data protection agency authorized to issue
substantive regulations and could result in increased privacy and information security enforcement. The majority of the provisions went into
effect on January 1, 2023, and additional compliance investment and potential business process changes may be required. Similar laws have
passed in Virginia, Colorado, Connecticut and Utah, and have been proposed in other states and at the federal level, reflecting a trend
toward more stringent privacy legislation in the United States. The enactment of such laws could have potentially conflicting requirements
that would make compliance challenging. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic
privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial
condition.
Furthermore, the Federal Trade Commission, or FTC, and many state Attorneys General continue to enforce federal and state consumer
protection laws against companies for online collection, use, dissemination and security practices that appear to be unfair or deceptive. For
example, according to the FTC, failing to take appropriate steps to keep consumers’ personal information secure can constitute unfair acts or
practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act. The FTC expects a company’s data
security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and
complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.
We are also or may become subject to rapidly evolving data protection laws, rules and regulations in foreign jurisdictions. For example, in
Europe, the European Union General Data Protection Regulation, or GDPR, went into effect in May 2018 and imposes strict requirements for
processing the personal data of individuals within the European Economic Area, or EEA. Companies that must comply with the GDPR face
increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines
for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. Among other
requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries that have not been found to provide
adequate protection to such personal data, including the United States; in July 2020, the Court of Justice of the European Union, or CJEU
limited how organizations could lawfully transfer personal data from the European Union, or EU, and the EEA to the United States by
invalidating the Privacy Shield for purposes of international transfers and imposing further restrictions on the use of standard contractual
clauses, or SCCs. In March 2022, the US and EU announced a new regulatory regime intended to replace the invalidated regulations;
however, this new EU-US Data Privacy Framework has not been implemented beyond an executive order signed by President Biden on
October 7, 2022 on Enhancing Safeguards for United States Signals Intelligence Activities. European court and regulatory decisions
subsequent to the CJEU decision of July 16, 2020 have taken a restrictive approach to international data transfers. As supervisory authorities
issue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or start taking
enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to
transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our
services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.
Since the beginning of 2021, after the end of the transition period following the United Kingdom’s departure from the EU, we are also subject
to the United Kingdom data protection regime, which imposes separate but similar obligations to those under the GDPR and comparable
penalties, including fines of up to £17.5 million or 4% of a noncompliant company’s global annual revenue for the preceding financial year,
whichever is greater. As we continue to expand into other foreign countries and jurisdictions, we may be subject to additional laws and
regulations that may affect how we conduct business.
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Risks Related to Our Intellectual Property
Risks Related to Protecting 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.
Our success depends in large part on our ability to obtain and maintain patent protection and trade secret protection in the United States and
other countries with respect to our proprietary products and product candidates. If we do not adequately protect our intellectual property
rights, competitors may be able to erode or negate any competitive advantage we may have, which could harm our business and ability to
achieve profitability. To protect our proprietary position, we file patent applications in the United States and abroad related to our novel
products and product candidates that are important to our business; we also may license or purchase patent applications filed by others. The
patent application and approval process is expensive and time-consuming. We may not be able to file and prosecute all necessary or
desirable patent applications at a reasonable cost or in a timely manner.
Agreements through which we license patent rights may not give us control over patent prosecution or maintenance, so that we may not be
able to control which claims or arguments are presented and may not be able to secure, maintain, or successfully enforce necessary or
desirable patent protection from those patent rights. We have not had and do not have primary control over patent prosecution and
maintenance for certain of the patents and patent applications we license, and therefore cannot guarantee that these patents and
applications will be prosecuted or maintained in a manner consistent with the best interests of our business. We are reliant on patents and
patent applications that we license for our product candidates and failure by owners of this intellectual property to enforce claims could have
a negative impact on our business. We cannot be certain that patent prosecution and maintenance activities by our licensors have been or
will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents.
If the scope of the patent protection we or our licensors obtain is not sufficiently broad, we may not be able to prevent others from developing
and commercializing technology and products similar or identical to ours. The degree of patent protection we require to successfully compete
in the marketplace may be unavailable or severely limited in some cases and may not adequately protect our rights or permit us to gain or
keep any competitive advantage. We cannot provide any assurances that any of our licensed patents have, or that any of our pending
licensed patent applications that mature into issued patents will include, claims with a scope sufficient to protect our current and future
products and product candidates or otherwise provide any competitive advantage, nor can we assure you that our licenses are or will remain
in force. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Furthermore,
patents have a limited lifespan. In the United States, the natural expiration of a patent is generally twenty years after it is filed. Various
extensions may be available; however, the life of a patent, and the protection it affords, is limited. Given the amount of time required for the
development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly
after such candidates are commercialized. As a result, our licensed patent portfolio may not provide us with adequate and continuing patent
protection sufficient to exclude others from commercializing products similar to our products and product candidates. In addition, the patent
portfolio licensed to us is, or may be, licensed to third parties, such as outside our field, and such third parties may have certain enforcement
rights. Thus, patents licensed to us could be put at risk of being invalidated or interpreted narrowly in litigation filed by or against another
licensee or in administrative proceedings brought by or against another licensee in response to such litigation or for other reasons.
Even if they are unchallenged, our owned and licensed patents and pending patent applications, if issued, may not provide us with any
meaningful protection or prevent competitors from designing around our patent claims to circumvent our or our licensors’ patents by
developing similar or alternative technologies or therapeutics in a non-infringing manner. For example, a third party may develop a
competitive therapy that provides benefits similar to one or more of our product candidates but that uses a formulation and/or a device that
falls outside the scope of our patent protection or license rights. If the patent protection provided by the patents and patent applications we
hold or pursue with respect to our products and product candidates is not sufficiently broad to impede such competition, our ability to
successfully commercialize our products and product candidates could be negatively affected, which would harm our business. Similar risks
would apply to any patents or patent applications that we may own or in-license in the future.
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We, or any future partners, collaborators, or licensees, may fail to identify patentable aspects of inventions made in the course of
development and commercialization activities before it is too late to obtain patent protection on them. Therefore, we may miss potential
opportunities to strengthen our patent position.
It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for
example, with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. If we or our partners,
collaborators, licensees, or licensors, whether current or future, fail to establish, maintain or protect such patents and other intellectual
property rights, such rights may be reduced or eliminated. If our partners, collaborators, licensees, or licensors, are not fully cooperative or
disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there
are material defects in the form, preparation, prosecution, or enforcement of our patents or patent applications, such patents may be invalid
and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to
prevent competition from third parties, which may have an adverse impact on our business.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain. No consistent policy regarding the breadth
of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United States or in many foreign jurisdictions. In
addition, the determination of patent rights with respect to pharmaceutical compounds commonly involves complex legal and factual
questions, which has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and
commercial value of our patent rights are highly uncertain.
Moreover, because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, our patents or pending
patent applications may be challenged in the courts or patent offices in the United States and abroad. There is no assurance that all of the
potentially relevant prior art relating to our patents and patent applications has been found. If such prior art exists, it may be used to
invalidate a patent, or may prevent a patent from issuing from a pending patent application. For example, such patent filings may be subject
to a third-party preissuance submission of prior art to the USPTO or to other patent offices around the world.
Patent applications are generally maintained in confidence until publication. In the United States, for example, patent applications are
typically maintained in secrecy for up to 18 months after their filing date. Similarly, publication of discoveries in scientific or patent literature
often lags behind actual discoveries. Consequently, we cannot be certain that we were the first to file patent applications on our products and
product candidates. Any of the foregoing could harm our competitive position, business, financial condition, results of operations, and
prospects.
Alternately or additionally, we may become involved in post-grant review procedures, oppositions, derivations proceedings, reexaminations,
inter partes review or interference proceedings, in the United States or elsewhere, challenging patents or patent applications in which we
have rights, including patents on which we rely to protect our business. An adverse determination in any such challenges may result in loss
of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop
others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our
technology and products.
Pending and future patent applications may not result in patents being issued which protect our business, in whole or in part, or which
effectively prevent others from commercializing competitive products. Changes in either the patent laws or interpretation of the patent laws in
the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. In addition, the laws
of foreign countries may not protect our rights to the same extent or in the same manner as the laws of the United States. For example,
patent laws in various jurisdictions, including significant commercial markets such as Europe, restrict the patentability of methods of
treatment of the human body more than United States law does.
The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our future
development partners will be successful in protecting our products and product candidates by obtaining and defending patents. These risks
and uncertainties include the following:
•
the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary,
fee payment and other provisions during the patent process. There are situations in which noncompliance can result in
abandonment or lapse of a patent or patent
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•
•
•
•
•
application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might
be able to enter the market earlier than would otherwise have been the case;
patent applications may not result in any patents being issued;
patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked, circumvented, found to be
unenforceable or otherwise may not provide any competitive advantage;
our competitors, many of whom have substantially greater resources and many of whom have made significant investments in
competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to
make, use, and sell our potential product candidates;
there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent
protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy
regarding worldwide health concerns; and
countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts,
allowing foreign competitors a better opportunity to create, develop and market competing product candidates in such
countries.
Issued patents that we have or may obtain or license may not provide us with any meaningful protection, prevent competitors from competing
with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our or our licensors’ patents by
developing similar or alternative technologies or products in a non-infringing manner. Our competitors may also seek approval to market their
own products similar to or otherwise competitive with our products. Alternatively, our competitors may seek to market generic versions of any
approved products by submitting ANDAs to the FDA in which they claim that patents owned or licensed by us are invalid, unenforceable or
not infringed. In these circumstances, we may need to defend or assert our patents, or both, including by filing lawsuits alleging patent
infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid or unenforceable, or
that our competitors are competing in a non-infringing manner. Thus, even if we have valid and enforceable patents, these patents still may
not provide protection against competing products or processes sufficient to achieve our business objectives.
Pursuant to the terms of potential license agreements with third parties, some of our third-party licensors may have the right, but not the
obligation in certain circumstances to control enforcement of our licensed patents or defense of any claims asserting the invalidity of these
patents. Even if we are permitted to pursue such enforcement or defense, we will require the cooperation of our licensors, and cannot
guarantee that we would receive it and on what terms. We cannot be certain that our licensors will allocate sufficient resources or prioritize
their or our enforcement of such patents or defense of such claims to protect our interests in the licensed patents. If we cannot obtain patent
protection, or enforce existing or future patents against third parties, our competitive position and our financial condition could suffer.
In addition, we rely on the protection of our trade secrets and proprietary know-how. Although we have taken steps to protect our trade
secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and
inventions agreements with employees, consultants and advisors, we cannot provide any assurances that all such agreements have been
duly executed, and there is a risk that third parties may still obtain this information or may come upon this or similar information
independently. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse
against third parties for misappropriating our trade secrets. If any of these events occurs or if we otherwise lose protection for our trade
secrets or proprietary know-how, our business may be harmed.
It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their
protection.
Our commercial success will depend, in part, on obtaining and maintaining patent protection and trade secret protection for the formulations
and compounds of our products and product candidates, the methods used to manufacture them, and associated methods of treatment as
well as on successfully defending these patents against potential third-party challenges. Our ability to protect our products and product
candidates from unauthorized making, using, selling, offering to sell or importing by third parties is dependent on the extent to which we have
rights under valid and enforceable patents that cover these activities.
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The patent positions of pharmaceutical, biotechnology and other life sciences companies can be highly uncertain and involve complex legal
and factual questions for which important legal principles remain unresolved. Changes in either the patent laws or in interpretations of patent
laws in the United States and other countries may diminish the value of our intellectual property. Further, the determination that a patent
application or patent claim meets all of the requirements for patentability is a subjective determination based on the application of law and
jurisprudence. The ultimate determination by the USPTO or by a court or other trier of fact in the United States, or corresponding foreign
national patent offices or courts, on whether a claim meets all requirements of patentability cannot be assured. We have not conducted
searches for third-party publications, patents and other information that may affect the patentability of claims in our various patent
applications and patents, so we cannot be certain that all relevant information has been identified. Accordingly, we cannot predict the breadth
of claims that may be allowed or enforced in our patents or patent applications, in our licensed patents or patent applications or in third-party
patents.
We cannot provide assurances that any of our patent applications will be found to be patentable, including over our own prior art patents, or
will issue as patents. Neither can we make assurances as to the scope of any claims that may issue from our pending and future patent
applications nor to the outcome of any proceedings by any potential third parties that could challenge the patentability, validity or
enforceability of our patents and patent applications in the United States or foreign jurisdictions. Any such challenge, if successful, could limit
patent protection for our product candidates and/or materially harm our business.
The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not
adequately protect our rights or permit us to gain or keep our competitive advantage. For example:
•
•
•
•
•
•
we may not be able to generate sufficient data to support full patent applications that protect the entire breadth of
developments in one or more of our programs;
it is possible that one or more of our pending patent applications will not become an issued patent or, if issued, that the
patent(s) will not: (a) be sufficient to protect our technology, (b) provide us with a basis for commercially viable products or (c)
provide us with any competitive advantages;
we may not be the first to make the inventions covered by each of our patents and pending patent applications;
we may not be the first to file patent applications for these inventions;
if our pending applications issue as patents, they may be challenged by third parties as not infringed, invalid or unenforceable
under U.S. or foreign laws; or
if issued, the patents under which we hold rights may not be valid or enforceable.
In addition, to the extent that we are unable to obtain and maintain patent protection for one of our product candidates or in the event that
such patent protection expires, it may no longer be cost-effective to extend our portfolio by pursuing additional development of a product
candidate for follow-on indications.
We also may rely on trade secrets to protect our technologies or product candidates, especially where we do not believe patent protection is
appropriate or obtainable. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets,
there is a risk that our employees, consultants, contractors, outside scientific collaborators and other advisers may unintentionally or willfully
disclose our information to competitors. Enforcing a claim that a third-party entity illegally obtained and is using any of our trade secrets is
expensive and time-consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to
protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
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.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and patent applications are required
to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the
patents and applications. The USPTO and various
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non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar
provisions during the patent application process and after a patent has issued. There are situations in which non-compliance can result in
abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
Under the terms of some of our licenses, we do not have the ability to maintain or prosecute patents in the portfolio, and must therefore rely
on third parties to comply 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.
Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such
candidates might expire before or shortly after such candidates are commercialized. We expect to seek extensions of patent terms in the
United States, if available, and, if available, in other countries where we are prosecuting patents. In the United States, the Drug Price
Competition and Patent Term Restoration Act of 1984 (or Hatch-Waxman Act) permits a patent term extension of up to five years beyond the
normal expiration of the patent, which is limited to the approved indication. However, the applicable authorities, including the FDA and the
USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such
extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If this
occurs, our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and
preclinical data and launch their product earlier than might otherwise be the case.
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.
As is the case with other biotechnology and pharmaceutical companies, our success is heavily dependent on intellectual property, particularly
patents. Obtaining and enforcing patents in the biotechnology and pharmaceutical industries involves both technological and legal complexity
and is therefore costly, time consuming and inherently uncertain. Recent patent reform legislation in the United States, including the Leahy-
Smith America Invents Act, or the America Invents Act, could increase those uncertainties and costs. The America Invents Act was signed
into law on September 16, 2011, and many of the substantive changes became effective on March 16, 2013. The America Invents Act
reforms United States patent law in part by changing the U.S. patent system from a “first-to-invent” system to a “first-inventor-to-file” system,
expanding the definition of prior art, and developing a post-grant review system. This legislation changes United States patent law in a way
that may weaken our ability to obtain patent protection in the United States for those applications filed after March 16, 2013.
Further, the America Invents Act created new procedures to challenge the validity of issued patents in the United States, including post-grant
review and inter partes review proceedings, which some third parties have been using to cause the cancellation of selected or all claims of
issued patents. For a patent with an effective filing date of March 16, 2013 or later, a petition for post-grant review can be filed by a third party
in a nine month window from issuance of the patent. A petition for inter partes review can be filed immediately following the issuance of a
patent if the patent has an effective filing date prior to March 16, 2013. A petition for inter partes review can be filed after the nine month
period for filing a post-grant review petition has expired for a patent with an effective filing date of March 16, 2013 or later. Post-grant review
proceedings can be brought on any ground of invalidity, whereas inter partes review proceedings can only raise an invalidity challenge based
on published prior art including patents. In these adversarial actions, the USPTO reviews patent claims without the presumption of validity
afforded to U.S. patents in lawsuits in U.S. federal courts and uses a lower burden of proof than used in litigation in U.S. federal courts.
Therefore, it is generally considered easier for a competitor or third party to have a U.S. patent invalidated in a USPTO post-grant review or
inter partes review proceeding than invalidated in litigation in a U.S. federal court. If any of our or our licensors’ patents are challenged by a
third party in such a USPTO proceeding, there is no guarantee that we or our licensors or collaborators will be successful in defending the
patent, which would result in a loss of the challenged patent rights to us.
Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the
laws and regulations governing patents could change in unpredictable ways that
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would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.
For example, a European Unified Patent Court (UPC) is scheduled to come into force during 2023. The UPC will be a common patent court
to hear patent infringement and revocation proceedings effective for member states of the European Union. This could enable third parties to
seek revocation of any of our European patents in a single proceeding at the UPC rather than through multiple proceedings in each of the
jurisdictions in which the European patent is validated. Any such revocation and loss of patent protection could have a material adverse
impact on our business and our ability to commercialize or license our technology and products. Moreover, the controlling laws and
regulations of the UPC will develop over time and may adversely affect our ability to enforce our European patents or defend the validity
thereof. We may decide to opt out our European patents and patent applications from the UPC. If certain formalities and requirements are
not met, however, our European patents and patent applications could be challenged for non-compliance and brought under the jurisdiction
of the UPC. We cannot be certain that our European patents and patent applications will avoid falling under the jurisdiction of the UPC, if we
decide to opt out of the UPC.
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.
In addition to the protection afforded by patents, we also rely on trade secret protection for certain aspects of our intellectual property. We
seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to
them, such as our employees, consultants, independent contractors, advisors, contract manufacturers, suppliers and other third parties. We
also enter into confidentiality and invention or patent assignment agreements with employees and certain consultants. There is a risk that any
party with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including our
trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or
misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. Additionally, if the steps taken to
maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating such trade
secrets. Further, if any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right
to prevent such third party, or those to whom they communicate such technology or information, from using that technology or information to
compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our business and
competitive position could 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 trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other
marks. We rely on both registration and common law protection for our trademarks. We may not be able to protect our rights to these
trademarks and trade names or may be forced to stop using these names, which we need for name recognition by potential partners or
customers in our markets of interest. During the trademark registration process, we may receive Office Actions from the USPTO objecting to
the registration of our trademark. Although we would be given an opportunity to respond to those objections, we may be unable to overcome
such rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to
oppose pending trademark applications and/or to seek the cancellation of registered trademarks. Opposition or cancellation proceedings may
be filed against our trademarks, and our trademarks may not survive such proceedings. If we are unable to establish name recognition based
on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected.
An NDA submitted under 505(b)(2) may subject us to a patent infringement lawsuit that would delay or prevent product candidate
review or approval.
Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes from preclinical
studies and/or clinical trials that were not conducted by, or for, the applicant and for which the applicant has not obtained a right of reference.
An NDA under 505(b)(2) would enable us to reference published literature and/or the FDA’s previous findings of safety and effectiveness for
a previously approved drug.
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For NDAs submitted under section 505(b)(2), the patent certification and related provisions of the Hatch-Waxman Act apply. Accordingly, if
we rely for approval on the safety or effectiveness information for a previously approved drug, referred to as a listed drug, we will be required
to include patent certifications in the 505(b)(2) NDA regarding any patents covering the listed drug. If there are patents listed in the FDA
publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for the listed drug,
and we seek to obtain approval prior to the expiration of one or more of those patents, we will be required to submit a Paragraph IV
certification indicating our belief that the relevant patents are invalid, unenforceable or will not be infringed by the manufacture, use or sale of
the product that is the subject of the 505(b)(2) NDA. Otherwise, a 505(b)(2) application cannot be approved by the FDA until the expiration of
any patents listed in the Orange Book for the listed drug.
In addition, a 505(b)(2) application will not be approved until any non-patent exclusivity listed in the Orange Book for the listed drug, or for
any other drug with the same, protected conditions of approval as the product candidate, has expired. These factors, among others, may limit
our ability to gain approval of or successfully commercialize our product candidates.
Risks Related to Intellectual Property Claims or Litigation
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.
Our commercial success depends in large part on our avoiding infringement of the patents and proprietary rights of third parties for existing
approved drug products. Because we utilize the 505(b)(2) regulatory approval pathway for the approval of our product candidates, we rely in
whole or in part on studies conducted by third parties related to those approved drug products. As a result, upon filing with the FDA for
approval of our product candidates, we will be required to certify to the FDA that either: (1) there is no patent information listed in the Orange
Book for the listed drug; (2) the patents listed in the Orange Book have expired; (3) the listed patents have not expired, but will expire on a
particular date and approval is sought after patent expiration; or (4) the listed patents are invalid or will not be infringed by the manufacture,
use or sale of our proposed drug product. We can avoid certifying to a method-of-use patent if we do not seek approval of the patented
condition of use. If we certify to the FDA that a patent is invalid or not infringed, or a Paragraph IV certification, a notice of the Paragraph IV
certification must also be sent to the patent owner and NDA holder shortly after our 505(b)(2) NDA is accepted for filing by the FDA. The third
party may then initiate a lawsuit against us asserting infringement of the patents identified in the notice. The filing of a patent infringement
lawsuit within 45 days of receipt of the notice automatically prevents the FDA from approving our 505(b)(2) application until the earliest of 30
months or the date on which the patent expires, the lawsuit is settled, or the court reaches a decision in the infringement lawsuit in our favor.
If the third party does not file a patent infringement lawsuit within the required 45-day period, our application will not be subject to the 30-
month stay. However, even if the third party does not sue within the 45-day time limit, thereby invoking the 30-month stay, it may still
challenge our right to market our product upon FDA approval; therefore, some risk of an infringement suit remains even after the expiry of the
45-day limit.
We may not be able to enforce our intellectual property rights throughout the world.
Filing, prosecuting, enforcing and defending patents on our products and product candidates in all countries throughout the world would be
prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in
the United States. The requirements for patentability may differ in certain countries, particularly in developing countries; thus, even in
countries where we do pursue patent protection, there can be no assurance that any patents will issue with claims that cover our products
and product candidates.
Moreover, our ability to protect and enforce our intellectual property rights may be adversely affected by unforeseen changes in foreign
intellectual property laws. Additionally, laws of some countries outside of the United States and Europe do not afford intellectual property
protection to the same extent as the laws of the United States and Europe. Many companies have encountered significant problems in
protecting and defending intellectual property rights in certain foreign jurisdictions. The legal systems of some countries, including India,
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China and other developing countries, do not favor the enforcement of patents and other intellectual property rights. This could make it
difficult for us to stop the infringement of our patents or the misappropriation of our other intellectual property rights. For example, many
foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. Consequently, we may not
be able to prevent third parties from practicing our inventions in certain countries outside the United States and Europe. Competitors may use
our technologies in jurisdictions where we have not obtained patent protection to develop and market their own products and, further, may
export otherwise infringing products to territories where we have patent protection, if our ability to enforce our patents to stop infringing
activities is inadequate. These products may compete with our products, and our patents or other intellectual property rights may not be
effective or sufficient to prevent them from competing.
Agreements through which we license patent rights may not give us sufficient rights to permit us to pursue enforcement of our licensed
patents or defense of any claims asserting the invalidity of these patents (or control of enforcement or defense) of such patent rights in all
relevant jurisdictions as requirements may vary.
Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our
efforts and resources from other aspects of our business. Moreover, such proceedings could put our patents at risk of being invalidated or
interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not
prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful.
Furthermore, while we intend to protect our intellectual property rights in major markets for our products, we cannot ensure that we will be
able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our products. Accordingly, our efforts to protect
our intellectual property rights in such countries may be inadequate.
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.
A third party may claim an ownership interest in one or more of our or our licensors’ patents or other proprietary or intellectual property rights.
A third party could bring legal actions against us and seek monetary damages and/or enjoin clinical testing, manufacturing and marketing of
the affected product or products. While we are presently unaware of any claims or assertions by third parties with respect to our patents or
other intellectual property, we cannot guarantee that a third party will not assert a claim or an interest in any of such patents or intellectual
property. If we become involved in any litigation, it could consume a substantial portion of our resources, and cause a significant diversion of
effort by our technical and management personnel. If any of these actions are successful, in addition to any potential liability for damages, we
could be required to obtain a license to continue to manufacture or market the affected product, in which case we may be required to pay
substantial royalties or grant cross-licenses to our patents. We cannot, however, assure you that any such license will be available on
acceptable terms, if at all. Ultimately, we could be prevented from commercializing a product candidate, or be forced to cease some aspect of
our business operations as a result of claims of patent infringement or violation of other intellectual property rights, Further, the outcome of
intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance, including the demeanor and
credibility of witnesses and the identity of any adverse party. This is especially true in intellectual property cases that may turn on the
testimony of experts as to technical facts upon which experts may reasonably disagree.
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.
Our commercial success depends, in part, on our ability to develop, manufacture, market and sell our product candidates without infringing
the intellectual property and other proprietary rights of third parties. Third parties may have U.S. and non-U.S. issued patents and pending
patent applications relating to compounds, formulations, methods of manufacturing compounds and/or formulations, and/or methods of use
for the treatment of the disease indications for which we are developing our product candidates. If any third-party patents or patent
applications are found to cover our products or product candidates or their methods of use or manufacture, we may not be free to
manufacture or market our product candidates as planned without obtaining a license, which may not be available on commercially
reasonable terms, or at all.
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There is a substantial amount of intellectual property litigation in the biotechnology and pharmaceutical industries, and we may become party
to, or threatened with, litigation or other adversarial proceedings regarding intellectual property rights with respect to our product candidates,
including interference and post-grant proceedings before the USPTO. There may be third-party patents or patent applications with claims to
materials, formulations, methods of manufacture or methods for treatment related to the formulations, use or manufacture of our product
candidates. We cannot guarantee that any of our patent analyses including, but not limited to, the scope of patent claims or the expiration of
relevant patents are complete or thorough, nor can we be certain that we have identified each and every patent and pending application in
the United States and abroad that is relevant to or necessary for the commercialization of our products and product candidates in any
jurisdiction. Because patent applications can take many years to issue, there may be currently pending patent applications which may later
result in issued patents that our products or product candidates may be accused of infringing. In addition, third parties may obtain patents in
the future and claim that use of our technologies infringes upon these patents. Accordingly, third parties may assert infringement claims
against us based on intellectual property rights that exist now or arise in the future. The outcome of intellectual property litigation is subject to
uncertainties that cannot be adequately quantified in advance. The pharmaceutical and biotechnology industries have produced a significant
number of patents, and it may not always be clear to industry participants, including us, which patents cover various types of products or
methods of use or manufacture. The scope of protection afforded by a patent is subject to interpretation by the courts, and the interpretation
is not always uniform. If we were sued for patent infringement, we would need to demonstrate that our products or product candidates, or
methods of use or of making either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or
unenforceable, and we may not be able to do this. Proving invalidity is difficult. For example, in the United States, proving invalidity requires a
showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in
these proceedings, we may incur substantial costs and the time and attention of our management and scientific personnel could be diverted
in pursuing these proceedings, which could significantly harm our business and operating results. In addition, we may not have sufficient
resources to bring these actions to a successful conclusion.
If we are found to infringe a third party’s intellectual property rights, we could be forced, including by court order, to cease developing,
manufacturing or commercializing the infringing product or product candidate. Alternatively, we may be required to obtain a license from such
third party in order to use the infringing technology and continue developing, manufacturing or marketing the infringing product or product
candidate. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to
obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us; alternatively or
additionally, it could include terms that impede or destroy our ability to compete successfully in the commercial marketplace. In addition, we
could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent.
A finding of infringement could prevent us from commercializing our products or product candidates or force us to cease some of our
business operations, which could harm our business. Claims that we have misappropriated the confidential information or trade secrets of
third parties could have a similar negative impact on our business.
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.
Many of our current and former employees, including our senior management, were previously employed at universities or at other
biotechnology or pharmaceutical companies, including some which may be competitors or potential competitors. Some of these employees,
including each member of our senior management, executed proprietary rights, non-disclosure and non-competition agreements, or similar
agreements, in connection with such previous employment. Although we try to ensure that our employees do not use the proprietary
information or know-how of others in their work for us, we may be subject to claims that we or these employees have used or disclosed
intellectual property, including trade secrets or other proprietary information, of any such third party. Litigation may be necessary to defend
against such claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual
property rights or personnel or sustain damages. Such intellectual property rights could be awarded to a third party, and we could be required
to obtain a license from such third party to commercialize our technology, products or product candidates. Such a license may not be
available on commercially reasonable terms or at all. Even if we are successful in defending against such claims, litigation could result in
substantial costs and be a distraction to management.
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In addition, while we typically require our employees, consultants and contractors who may be involved in the development of intellectual
property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with
each party who in fact develops intellectual property that we regard as our own, which may result in claims by or against us related to the
ownership of such intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we
may lose valuable intellectual property rights. Even if we are successful in prosecuting or defending against such claims, litigation could
result in substantial costs and be a distraction to our senior management and scientific personnel.
We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive,
time consuming and unsuccessful.
Competitors may infringe our patents, trademarks, copyrights or other intellectual property. To counter infringement or unauthorized use, we
may be required to file infringement claims, which can be expensive and time consuming and divert the time and attention of our
management and scientific personnel. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims
against us alleging that we infringe their patents, in addition to counterclaims asserting that our patents are invalid or unenforceable, or both.
In any patent infringement proceeding, there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in
part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of
such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from
using the invention at issue on the grounds that our patent claims do not cover the invention. An adverse outcome in a litigation or
proceeding involving one or more of our patents could limit our ability to assert those patents against those parties or other competitors, and
may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Similarly, if we assert
trademark infringement claims, a court may determine that the marks we have asserted are unenforceable, that the alleged infringing mark
does not infringe our trademark rights, or that the party against whom we have asserted trademark infringement has superior rights to the
marks in question. In this last instance, we could ultimately be forced to cease use of such trademarks.
Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only
monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in
connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure
during litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments.
If securities analysts or investors perceive these results to be negative, it could adversely affect the price of shares of our common stock.
Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims,
which typically last for years before they are concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation and
the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the
proceedings.
Additionally, for certain of our in-licensed patent rights, we do not have the right to bring suit for infringement and must rely on third parties to
enforce these rights for us. If we cannot or choose not to take action against those we believe infringe our intellectual property rights, we may
have difficulty competing in certain markets where such potential infringers conduct their business, and our commercialization efforts may
suffer as a result.
Risks Related to Our Reliance on Third Parties
Risks Related to Third Party Performance
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 do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our products and product
candidates, and we lack the resources and the capabilities to do so. As a result, we currently rely on third parties for supply of the active
pharmaceutical ingredients, or API, in our products and product candidates, and our furosemide formulation, as well as the device
components of our drug-device combination products and product candidates. Our current strategy is to outsource all manufacturing of our
product candidates and products to third parties.
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We currently engage third-party manufacturers to manufacture FUROSCIX and related supplies and packaging. For example, we have
engaged a third-party manufacturer for the manufacture of the furosemide formulation used in FUROSCIX and we have engaged a third
party designer and manufacturer to develop and manufacture the on-body infusor for FUROSCIX. There is no guarantee that we can
maintain our relationships with these manufacturers and we may incur added costs and delays in identifying and qualifying any replacements
for such manufacturers. There is no assurance that we will be able to timely secure further needed supply arrangements on satisfactory
terms, or at all. Our failure to secure these arrangements as needed could have a material adverse effect on our ability to commercialize
FUROSCIX. There may be difficulties and delays in scaling up to commercial quantities of FUROSCIX and the costs of manufacturing could
be prohibitive. Beyond FUROSCIX, third parties also manufacture the materials that we require for the development of our product
candidates, and our reliance on these manufacturers for these activities carries similar risks as our reliance on third-party manufacturers in
connection with FUROSCIX.
Reliance on third-party manufacturers entails additional risks, including:
•
•
•
•
reliance on third parties for manufacturing process development, regulatory compliance and quality assurance;
limitations on supply availability resulting from capacity and scheduling constraints of third parties;
the possible breach of manufacturing agreements by third parties because of factors beyond our control; and
the possible termination or non-renewal of the manufacturing agreements by the third party, at a time that is costly or
inconvenient to us.
If we do not maintain our key manufacturing relationships or if our third-party manufactures fail to comply with applicable regulations, we may
need to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain
regulatory approval for our product candidates. If we do find replacement manufacturers, we may not be able to enter into agreements with
them on terms and conditions favorable to us and there could be a substantial delay before new facilities could be qualified and registered
with the FDA and other foreign regulatory authorities.
If any third-party manufacturer with whom we contract fails to perform its obligations, we may be forced to manufacture the materials
ourselves, for which we may not have the capabilities or resources, or enter into an agreement with a different third-party manufacturer,
which we may not be able to do on reasonable terms, if at all. In either scenario, our product supply could be delayed significantly as we
establish alternative supply sources. In some cases, the technical skills required to manufacture our products or product candidates may be
unique or proprietary to the original third-party manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting
us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all. In addition, if we are
required to change third-party manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and
procedures that comply with quality standards and with all applicable regulations, and may need to obtain prior FDA approval with respect to
any manufacturing changes for any approved products. We will also need to verify, such as through a manufacturing comparability study, that
any new manufacturing process will produce our product candidate according to the specifications previously submitted to the FDA or
another foreign regulatory authority. The delays associated with the verification of a new manufacturer could negatively affect our ability to
develop product candidates or commercialize our products in a timely manner or within budget. Furthermore, a third-party manufacturer may
possess technology related to the manufacture of our product candidate that such manufacturer owns independently. This would increase
our reliance on such third-party manufacturer or require us to obtain a license from such manufacturer in order to have another third party
manufacture our products and product candidates. In addition, changes in manufacturers often involve changes in manufacturing procedures
and processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of
any new manufacturer. We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of
additional clinical trials.
Our approved product, FUROSCIX, is a drug-device combination product that is regulated under the drug regulations of the FDA based on its
primary mode of action as a drug. Third-party manufacturers may not be able to comply with the cGMP requirements applicable to drug-
device combination products, including applicable provisions of the FDA’s drug cGMP regulations, device cGMP requirements embodied in
the QSR or similar
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regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable
regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or
withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of
which could significantly affect supplies of our product candidates.
We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with
cGMPs and QSR requirements or comparable foreign regulatory requirements. If our contract manufacturers cannot successfully
manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or other foreign regulatory
authorities, they will not be able to secure and/or maintain regulatory approval for the use of their manufacturing facilities for our products. In
addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and
qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our
product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which could
cause significant delays in our operating timelines and would significantly impact our ability to develop, obtain regulatory approval for or
market our product candidates, if approved. Contract manufacturers may face manufacturing or quality control problems causing drug
substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable
cGMP and QSR requirements. Any failure to comply with cGMP or QSR requirements or other FDA, EMA and comparable foreign regulatory
requirements could adversely affect our clinical research activities and our ability to develop our product candidates and market our products
following approval.
The FDA and other foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding
foreign regulators also inspect these facilities to confirm compliance with applicable cGMPs and QSR requirements and comparable foreign
regulatory requirements. Contract manufacturers may face manufacturing or quality control problems causing drug substance or device
component production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable
cGMP or QSR requirements or comparable foreign regulatory requirements. Any failure to comply with cGMP or QSR requirements or other
FDA and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our
product candidates and market our products following approval.
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 do not independently conduct clinical trials of any of our product candidates. We rely on third parties, such as CROs, clinical data
management organizations, medical institutions and clinical investigators, to conduct these clinical trials and expect to rely on these third
parties to conduct clinical trials of any other product candidate that we develop. Any of these third parties may terminate their engagements
with us under certain circumstances. We may not be able to enter into alternative arrangements or do so on commercially reasonable terms.
In addition, there is a natural transition period when a new CRO begins work. As a result, delays would likely occur, which could negatively
impact our ability to meet our expected clinical development timelines and harm our business, financial condition and prospects.
Further, although our reliance on these third parties for clinical development activities limits our control over these activities, we remain
responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific
standards. For example, notwithstanding the obligations of a CRO for a trial of one of our product candidates, we remain responsible for
ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover,
the FDA and foreign regulatory authorities require us to comply with standards, commonly referred to as Good Clinical Practices, or GCPs,
for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that
the rights, integrity and confidentiality of trial participants are protected. The FDA enforces these GCPs through periodic inspections of trial
sponsors, principal investigators, clinical trial sites and IRBs. Similar requirements apply in other jurisdictions, such as the EU. If we or our
third-party contractors fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the
FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our product candidates,
which would delay the marketing approval process. We cannot be certain that, upon inspection, the FDA or comparable foreign regulatory
authorities will determine that
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any of our clinical trials comply with GCPs. We are also required to register clinical trials and post the results of completed clinical trials on a
government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil
and criminal sanctions.
Furthermore, the third parties conducting clinical trials on our behalf are not our employees, and except for remedies available to us under
our agreements with such contractors, we cannot control whether or not they devote sufficient time, skill and resources to our ongoing
development programs. These contractors may also have relationships with other commercial entities, including our competitors, for whom
they may also be conducting clinical trials or other drug development activities, which could impede their ability to devote appropriate time to
our clinical programs. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our
clinical trials in accordance with regulatory requirements or our stated protocols, we may not be able to obtain, or may be delayed in
obtaining, marketing approvals for our product candidates. If that occurs, we will not be able to, or may be delayed in our efforts to,
successfully commercialize our product candidates. In such an event, our financial results and the commercial prospects for any product
candidates that we seek to develop could be harmed, our costs could increase and our ability to generate revenues could be delayed,
impaired or foreclosed.
Risks Related to Third Party Contracts
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.
In the normal course of business, we periodically enter into academic, commercial, service, collaboration, licensing, consulting and other
agreements that contain indemnification provisions. With respect to our academic and other research agreements, we typically indemnify the
institution and related parties from losses arising from claims relating to the products, processes or services made, used, sold or performed
pursuant to the agreements for which we have secured licenses, and from claims arising from our or our sublicensees’ exercise of rights
under the agreement. With respect to our commercial agreements, we indemnify our vendors from any third-party product liability claims that
could result from the production, use or consumption of the product, as well as for alleged infringements of any patent or other intellectual
property right by a third party.
Should our obligation under an indemnification provision exceed applicable insurance coverage or if we were denied insurance coverage, our
business, financial condition and results of operations could be adversely affected. Similarly, if we are relying on a collaborator to indemnify
us and the collaborator is denied insurance coverage or the indemnification obligation exceeds the applicable insurance coverage and does
not have other assets available to indemnify us, our business, financial condition and results of operations could be adversely affected.
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 expect to seek one or more collaborators for the development and commercialization of one or more of our product candidates. For
example, we started collaborating with West in 2019 for development of an on-body infusor. Likely collaborators may include large and mid-
size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies. In addition, if we are able to
obtain marketing approval for product candidates from foreign regulatory authorities, we intend to enter into strategic relationships with
international biotechnology or pharmaceutical companies for the commercialization of such product candidates outside of the United States.
We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for a collaboration will
depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed
collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the potential differentiation of our
product candidate from competing product candidates, design or results of clinical trials, the likelihood of approval by the FDA or comparable
foreign regulatory authorities and the regulatory pathway for any such approval, the potential market for the product candidate, the costs and
complexities of manufacturing and delivering the product to patients and the potential of competing products. The collaborator may also
consider alternative product candidates or technologies for similar indications that may be available for collaboration and whether such a
collaboration could be more attractive than
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the one with us for our product candidate. If we elect to increase our expenditures to fund development or commercialization activities on our
own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient
funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.
Collaborations are complex and time-consuming to negotiate and document. Further, there have been a significant number of recent
business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Any
collaboration agreements that we enter into in the future may contain restrictions on our ability to enter into potential collaborations or to
otherwise develop specified product candidates. We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at
all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate,
reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce
the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our
own expense.
Risks Related to Employee Matters, Managing Growth and Business Operations
Risks Related to Employee Matters
We only have a limited number of employees to manage and operate our business.
As of March 21, 2023, we had 96 full-time employees. Our focus on the development and commercialization of FUROSCIX has required us
to optimize cash utilization and to manage and operate our business in a lean manner. There can be no assurance that we will be able to hire
and/or retain adequate staffing levels to commercialize FUROSCIX or run our operations and/or to accomplish all of the objectives that we
otherwise would seek to accomplish.
We depend heavily on our executive officers, directors, and principal consultants and the loss of their services would materially
harm our business.
Our success depends, and will likely continue to depend, upon our ability to hire, retain the services of our current executive officers,
directors, principal consultants and others. In addition, we have established relationships with universities and research institutions which
have historically provided, and continue to provide, us with access to research laboratories, clinical trials, facilities and patients. Our ability to
compete in the biotechnology and pharmaceuticals industries depends upon our ability to attract and retain highly qualified managerial,
scientific and medical personnel.
Our industry has experienced a high rate of turnover of management personnel in recent years. Any of our personnel may terminate their
employment at will. If we lose one or more of our executive officers or other key employees, our ability to implement our business strategy
successfully could be seriously harmed. Departed personnel have sought to compete with us historically and may continue to do so in the
future. Furthermore, replacing executive officers or other key employees may be difficult and may take an extended period of time because of
the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain marketing approval of and
commercialize products successfully.
Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these additional key employees on
acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also
experience competition for the hiring of scientific and clinical personnel from universities and research institutions.
We rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and
commercialization strategy. Our consultants and advisors may be employed by other entities and may have commitments under consulting or
advisory contracts with those entities that may limit their availability to us. If we are unable to continue to attract and retain highly qualified
personnel, our ability to develop and commercialize our products and product candidates will be limited.
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Our company lacks experience commercializing products, which may have a material adverse effect on our business.
We are transitioning from a company with a development focus to a company capable of supporting commercial activities. We have
completed building our initial sales force and began the commercial launch of FUROSCIX in February 2023. Since FUROSCIX is our first
commercial product approved, we have not yet demonstrated an ability to commercialize a product candidate or to obtain marketing approval
for a product candidate outside of the U.S. Therefore, our clinical development, and commercialization processes and our regulatory
approval process in the U.S. or countries outside of the U.S. may involve more inherent risk, take longer, and cost more than it would if we
were a company with a more significant operating history and had experience obtaining approval and marketing approval for and
commercializing a product candidate.
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 are exposed to the risk that our employees, independent contractors, consultants, collaborators, contract research organizations,
principal investigators, suppliers and vendors may engage in fraud or other misconduct, including intentional, reckless and/or negligent
conduct that fails to comply with FDA regulations or similar regulations of comparable non-U.S. regulatory authorities, to provide true,
complete and accurate information to the FDA or comparable non-U.S. regulatory authorities, to comply with manufacturing standards we
have established, to comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations
established and enforced by comparable non-U.S. regulatory authorities, to report financial information or data accurately or to disclose
unauthorized activities to us. Such misconduct could also involve the improper use or misrepresentation of information obtained in the course
of clinical trials, creating fraudulent data in our preclinical studies or clinical trials or illegal misappropriation of product materials, which could
result in regulatory sanctions and serious harm to our reputation.
We have adopted a Code of Business Conduct and Ethics to aid our directors, officers, employees and certain designated agents in making
ethical and legal decisions when conducting business on our behalf and performing their day-to-day duties. However, it is not always possible
to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown
or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be
in compliance with such laws, standards or regulations. Additionally, we are subject to the risk that a private person or governmental agency
could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in
defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including
the imposition of significant fines or other sanctions.
Risks Related to Business Operations and Growth
We expect to expand our organization and, as a result, we may encounter difficulties in managing our growth, which could disrupt
our operations.
We expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of drug
manufacturing, regulatory affairs and sales, marketing and distribution, as well as to support our public company operations. To manage
these growth activities, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities
and continue to recruit and train additional qualified personnel. Our management may need to devote a significant amount of its attention to
managing these growth activities. Moreover, our expected growth could require us to relocate to a different geographic area of the country.
Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated
growth, we may not be able to effectively manage the expansion or relocation of our operations, retain key employees, or identify, recruit and
train additional qualified personnel. Our inability to manage the expansion or relocation of our operations effectively may result in
weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced
productivity among remaining employees. Our expected growth could also require significant capital expenditures and may divert financial
resources from other projects, such as the commercialization and development of FUROSCIX or additional product candidates. If we are
unable to effectively manage our expected growth, our expenses may increase more than expected, our ability to generate
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revenues could be reduced and we may not be able to implement our business strategy, including the successful commercialization of our
products and product candidates.
We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax
credit carryforwards.
As of December 31, 2022, we had federal net operating loss carryforwards of $17.5 million, which expire at various dates through 2037, and
$64.6 million, which may be carried forward indefinitely. At December 31, 2022, we had available state net operating loss carryforwards of
$72.6 million, which expire at various dates through 2042 and $300,000, which may be carried forward indefinitely. If not utilized, the net
operating loss carryforwards will expire. At December 31, 2022, we had federal and state research and development tax credit carryforwards
of $4.3 million and $1.0 million, respectively. If not utilized, the research and development credits expire at various dates through 2042. Our
ability to use our U.S. federal and state net operating loss and tax credit carryforwards to offset potential future taxable income and related
income taxes that would otherwise be due is dependent upon our generation of future taxable income. These net operating loss and tax
credit carryforwards could expire unused and be unavailable to offset future income tax liabilities. In addition, under Section 382 of the
Internal Revenue Code of 1986, as amended, or the Code, and corresponding provisions of state law, if a corporation undergoes an
“ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the
corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change
income may be limited.
In 2017 we experienced an ownership change that we believe under Section 382 of the Code will result in limitations in our ability to utilize
net operating losses and credits. In addition, we may experience future ownership changes as a result of future offerings or other changes in
ownership of our stock. As a result, the amount of the net operating loss and tax credit carryforwards presented in our consolidated financial
statements could be limited and may expire unutilized.
General Risk Factors
Our business and operations may suffer in the event of information technology system failures, cyberattacks or deficiencies in our
cybersecurity.
We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on
information technology systems and infrastructure to operate our business. In the ordinary course of our business, we collect, store and
transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information of
customers and our employees and contractors. It is critical that we do so in a secure manner to maintain the confidentiality and integrity of
such confidential information.
Our information technology systems and those of our third-party service providers, strategic partners and other contractors or consultants are
vulnerable to attack and damage or interruption from computer viruses and malware (e.g. ransomware), malicious code, natural disasters,
terrorism, war, telecommunication and electrical failures, hacking, cyberattacks, phishing attacks and other social engineering schemes,
employee theft or misuse, human error, fraud, denial or degradation of service attacks, sophisticated nation-state and nation-state-supported
actors or unauthorized access or use by persons inside our organization, or persons with access to systems inside our organization. We
have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could
have access to our confidential information.
Further, attacks upon information technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and
are being conducted by sophisticated and organized groups and individuals with a wide range of motives and expertise. As a result of the
COVID-19 pandemic, we may also face increased cybersecurity risks due to our reliance on internet technology and the number of our
employees who are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities. Furthermore,
because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until
launched against a target, we may be unable to anticipate these techniques or implement adequate preventative measures. We may also
experience security breaches that may remain undetected for an extended period. Even if identified, we may be unable to adequately
investigate or remediate
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incidents or breaches due to attackers increasingly using tools and techniques that are designed to circumvent controls, to avoid detection,
and to remove or obfuscate forensic evidence.
We and certain of our service providers are from time to time subject to cyberattacks and security incidents. While we do not believe that we
have experienced any significant system failure, accident or security breach to date, if such an event were to occur and cause interruptions in
our operations, it could result in a material disruption of our development programs and our business operations, whether due to a loss,
corruption or unauthorized disclosure of our trade secrets, personal information or other proprietary or sensitive information or other similar
disruptions. If a security breach or other incident were to result in the unauthorized access to or unauthorized use, disclosure, release or
other processing of personal information, it may be necessary to notify individuals, governmental authorities, supervisory bodies, the media
and other parties pursuant to privacy and security laws. We could also incur liability, including litigation exposure, penalties and fines, and we
could become the subject of regulatory action or investigation. Our competitive position could be harmed and the further development and
commercialization of our products and services could be delayed. We maintain cyber liability insurance; however, this insurance may not be
sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems.
Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our
products and product candidates.
The risk that we may be sued on product liability claims is inherent in the development of drug formulation and device products. We face a
risk of product liability exposure related to the testing of our current and future product candidates in clinical trials and will face even greater
risks upon any commercialization by us of our products and product candidates. Product liability claims might be brought against us by
consumers, healthcare providers or others coming into contact with our products and product candidates. These lawsuits may divert our
management from pursuing our business strategy and may be costly to defend. In addition, if we are held liable in any of these lawsuits, we
may incur substantial liabilities and may be forced to limit or forego further commercialization of one or more of our products which could
adversely affect our stock price and our operations.
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.
Any disputes with such third parties that lead to litigation or similar proceedings may result in us incurring legal expenses, as well as facing
potential legal liability. Such disputes, litigation or other proceedings are also time consuming and may cause delays in our development and
commercialization efforts. If we fail to resolve these disputes quickly and on favorable terms, our business, results of operations, and financial
condition may be harmed.
Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and
share price.
The global economy, including credit and financial markets, has recently experienced extreme volatility and disruptions, including, for
example, severely diminished liquidity and credit availability, rising interest and inflation rates, crises involving banking and financial
institutions, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about
economic stability. If the equity and credit markets continue to deteriorate, or the United States enters a recession, it may make any
necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive. In addition,
there is a risk that one or more of our CROs, suppliers, CMOs, or other third-party providers may not survive an economic downturn or
recession. As a result, our business, results of operations and price of our common stock may be adversely affected.
Risks Related to Ownership of Our Common Stock
The trading price of our common stock may be highly volatile and fluctuate substantially.
Our stock price is likely to be highly volatile. The stock market in general and the market for smaller pharmaceutical and biotechnology
companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular
companies. The market price for our common stock may be influenced by many factors, including:
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regulatory actions with respect to our product candidates, including any delays related to COVID-19;
the pricing, reimbursement and commercialization of FUROSCIX and of other product candidates that may be approved;
regulatory actions with respect to our competitors’ products and product candidates;
the success of existing or new competitive products or technologies;
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or
capital commitments;
the timing and results of clinical trials of our pipeline product candidates;
commencement or termination of collaborations for our development programs;
failure or discontinuation of any of our development programs;
results of clinical trials of product candidates of our competitors;
regulatory or legal developments in the United States and other countries;
developments or disputes concerning patent applications, issued patents or other proprietary rights, including proprietary rights
that we in-license from third parties;
the recruitment or departure of key personnel;
the level of expenses related to any of our products or product candidates or clinical development programs;
the results of our efforts to develop additional product candidates or products;
actual or anticipated changes in estimates as to financial results or development timelines;
announcement or expectation of additional financing efforts;
sales of our common stock by us, our insiders or other stockholders;
variations in our financial results or those of companies that are perceived to be similar to us;
changes in estimates or recommendations by securities analysts, if any, that cover our stock;
changes in the structure of healthcare payment systems;
market conditions in the pharmaceutical and biotechnology sectors;
general economic, industry and market conditions; and
the other factors described in this “Risk Factors” section.
Additionally, in the past, securities class action litigation has often been brought against a company following a decline in the market price of
its securities. This risk is especially relevant for us because pharmaceutical companies have experienced significant stock price volatility in
recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which
could harm our business.
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 expect our expenses to increase in connection with our planned operations. To the extent that we raise additional capital through the sale
of common stock, convertible securities or other equity securities, the ownership percentages of all our stockholders may be diluted, and the
terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of
our stockholders. In addition, royalty-based financing or debt financing, if available, may result in our relinquishing rights to valuable future
revenue streams or fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take
specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming stock or declaring dividends, that
could adversely impact our ability to conduct our business. In addition, securing financing could require a substantial amount of time and
attention
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from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely
affect our management’s ability to oversee the commercialization of FUROSCIX and the development of our product candidates.
If we raise additional funds through collaborations or marketing, distribution or licensing, or royalty-based financing arrangements with third
parties, we may have to relinquish valuable rights to our technologies, future revenue streams, products or product candidates or grant
licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit,
reduce or terminate our product development or commercialization efforts or grant rights to develop and market products or product
candidates that we would otherwise prefer to develop and market ourselves.
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.
We have never declared nor paid cash dividends on our capital stock. We currently plan to retain all of our future earnings, if any, to finance
the operation, development and growth of our business. In addition, the terms of any of our existing, and potentially future, debt or credit
agreements will restrict or preclude us from paying dividends. For example, under our Credit Agreement with Oaktree, we are restricted from
paying any dividends or making any distributions on account of our capital stock if we are in, or expected to be, in default. As a result, capital
appreciation, if any, of our common stock will be the sole source of gain for our stockholders for the foreseeable future.
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.
Based upon shares outstanding as of December 31, 2022, our executive officers and directors, combined with our stockholders who own
more than 5% of our outstanding common stock and their affiliates, in the aggregate, beneficially own shares representing approximately
61.7% of our common stock. As a result, if these stockholders were to choose to act together, they would be able to control all matters
submitted to our stockholders for approval, as well as our management and affairs. For example, these persons, if they choose to act
together, would control the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets. This
concentration of ownership control may:
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entrench our management or the board of directors; or
impede a merger, consolidation, takeover or other business combination involving us that other stockholders may desire.
Some of these persons or entities may have interests that are different than those of other stockholders. For example, because many of
these stockholders purchased their shares at prices substantially below the price at which shares were sold in our initial public offering and
have held their shares for a longer period, they may be more interested in selling our company to an acquirer than other investors or they
may want us to pursue strategies that deviate from the interests of other stockholders.
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.
We are a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act. We may take
advantage of certain of the scaled disclosures available to smaller reporting companies until the fiscal year following the determination that
our voting and non-voting common stock held by non-affiliates is more than $250.0 million measured on the last business day of our second
fiscal quarter, or our annual revenues are more than $100.0 million during the most recently completed fiscal year and our voting and non-
voting common stock held by non-affiliates is more than $700.0 million measured on the last business day of our second fiscal quarter, which
we refer to as a low-revenue smaller reporting company.
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Our independent registered public accounting firm will not be required to provide an attestation report on the effectiveness of our internal
control over financial reporting so long as we qualify as a low-revenue smaller reporting company, which may increase the risk that material
weaknesses or significant deficiencies in our internal control over financial reporting go undetected. Likewise, so long as we qualify as a
smaller reporting company we may elect not to provide you with certain information, including certain financial information and certain
information regarding compensation of our executive officers, that we would otherwise have been required to provide in filings we make with
the SEC, which may make it more difficult for investors and securities analysts to evaluate our company. We cannot predict if investors will
find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as
a result, there may be a less active trading market for our common stock, and our stock price may be more volatile and may decline.
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.
As a result of operating as a public company, compliance with the Sarbanes-Oxley Act of 2002, as well as other rules and regulations
promulgated by the SEC and the Nasdaq Stock Market LLC, or Nasdaq, results in significant legal, accounting, administrative and other
costs and expenses. The listing requirements of the Nasdaq Global Select Market require that we satisfy certain corporate governance
requirements relating to director independence, distributing annual and interim reports, stockholder meetings, approvals and voting, soliciting
proxies, conflicts of interest and a code of conduct. Our management and other personnel will need to continue to devote a substantial
amount of time to ensure that we continue to comply with all of these requirements.
We are subject to Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, and the related rules of the SEC that generally require our
management and independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting.
Section 404 requires an annual management assessment of the effectiveness of our internal control over financial reporting. However, for so
long as we remain a low-revenue smaller reporting company, we intend to take advantage of certain exemptions from various reporting
requirements that are applicable to public companies that are not smaller reporting companies, including, but not limited to, not being
required to comply with the auditor attestation requirement of Section 404. Once we are no longer a low-revenue smaller reporting company
or, if before such date, we opt to no longer take advantage of the applicable exemption, we will be required to include an opinion from our
independent registered public accounting firm on the effectiveness of our internal control over financial reporting.
During the course of our review and testing of our internal controls, we may identify deficiencies and be unable to remediate them before we
must provide the required reports. Furthermore, if we have a material weakness in our internal control over financial reporting, we may not
detect errors on a timely basis and our financial statements may be materially misstated, especially for so long as our independent registered
public accounting firm is not required to provide an attestation report on the effectiveness of such internal controls over financial reporting.
We or our independent registered public accounting firm may not be able to conclude on an ongoing basis that we have effective internal
control over financial reporting, which could harm our operating results, cause investors to lose confidence in our reported financial
information and cause the trading price of our stock to fall. In addition, as a public company we are required to timely file accurate quarterly
and annual reports with the SEC under the Exchange Act. Any failure to report our financial results on an accurate and timely basis could
result in sanctions, lawsuits, delisting of our shares from the Nasdaq Global Select Market or other adverse consequences.
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.
Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in
the market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market price of our common
stock. Persons who were our stockholders prior to our IPO continue to hold a substantial number of shares of our common stock that many
of them are now able to sell in the public market. If these pre-IPO shares are sold, or if it is perceived that they will be sold, in the public
market, the trading price of our common stock could decline.
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Moreover, certain holders of securities issued prior to our IPO have rights, subject to conditions, to require us to file registration statements
covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders.
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.
The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or
our business. We do not have any control over these analysts. In the event one or more analysts downgrade our stock or change their
opinion of our stock, our share price would likely decline. In addition, if one or more analysts cease coverage of our company or fail to
regularly publish reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to
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.
We completed our initial public offering in November 2017. Prior to this time, there was no public market for our common stock. Although we
have completed our initial public offering and shares of our common stock are listed and trading on the Nasdaq Global Select Market, an
active trading market for our shares may not be sustained. If an active market for our common stock is not sustained, it may be difficult for
our stockholders to sell shares of our common stock without depressing the market price for the shares or at all. An inactive trading market
may also impair our ability to raise capital to continue to fund operations by selling shares and may impair our ability to acquire other
companies or technologies by using our shares as consideration.
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.
Provisions in our corporate charter and our bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us
that stockholders may consider favorable. These provisions could also limit the price that investors might be willing to pay in the future for
shares of our common stock, thereby depressing the market price of our common stock. In addition, because our board of directors is
responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our
stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of
directors. Among other things, these provisions:
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establish a classified board of directors such that all members of the board are not elected at one time;
allow the authorized number of our directors to be changed only by resolution of our board of directors;
limit the manner in which stockholders can remove directors from the board;
establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can
be acted on at stockholder meetings;
require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders
by written consent;
limit who may call a special meeting of stockholders;
authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a
“poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that
have not been approved by our board of directors; and
require the approval of the holders of at least two-thirds of the votes that all our stockholders would be entitled to cast to amend
or repeal certain provisions of our charter or bylaws.
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General Corporation Law of
the State of Delaware, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with
us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock,
unless the merger or combination is approved in a prescribed manner. This could discourage, delay or prevent someone from acquiring us or
merging with us, whether or not it is desired by, or beneficial to, our stockholders. This could also have the
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effect of discouraging others from making tender offers for our common stock. These provisions may also prevent changes in our
management or limit the price that investors are willing to pay for our stock.
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.
Pursuant to our bylaws, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware
is the sole and exclusive forum for state law claims for any state law claim for (1) any derivative action or proceeding brought on our behalf;
(2) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers, or other employees to us or our
stockholders; (3) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law or our certificate of
incorporation or bylaws; or (4) any action asserting a claim governed by the internal affairs doctrine, or the Delaware Forum Provision. The
Delaware Forum Provision will not apply to any causes of action arising under the Securities Act or the Exchange Act. Our bylaws further
provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America
are the sole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, or the Federal
Forum Provision, or the rules and regulations promulgated thereunder, and of all suits in equity and actions at law brought to enforce any
liability or duty created by the Securities Act or the rules and regulations thereunder. In addition, our bylaws provide that any person or entity
purchasing or otherwise acquiring any interest in shares of our Common Stock is deemed to have notice of and consented to the foregoing
Delaware Forum Provision and Federal Forum Provision; provided, however, that stockholders cannot and will not be deemed to have
waived our compliance with the U.S. federal securities laws and the rules and regulations thereunder.
The Delaware Forum Provision and the Federal Forum Provision may impose additional litigation costs on stockholders in pursuing any such
claims. Additionally, these forum selection clauses may limit our stockholders’ ability to bring a claim in a judicial forum that they find
favorable for disputes with us or our directors, officers or employees, which may discourage the filing of lawsuits against us and our directors,
officers and employees even though an action, if successful, might benefit our stockholders. While the Delaware Supreme Court and other
states have upheld the validity of federal forum selection provisions purporting to require claims under the Securities Act be brought in federal
court, there is uncertainty as to whether other courts will enforce our Federal Forum Provision. If the Federal Forum Provision is found to be
unenforceable, we may incur additional costs with resolving such matters. The Federal Forum Provision may also impose additional litigation
costs on us and/or our stockholders who assert that the provision is invalid or unenforceable. The Court of Chancery of the State of Delaware
or the federal district courts of the United States of America may also reach different judgments or results than would other courts, including
courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments may be
more or less favorable to us than our stockholders.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
Our principal executive offices are located in a 13,066 square foot facility in Burlington, Massachusetts. The term of the lease for our facility
extends through November 2023. We lease 2,037 square feet in Salem, New Hampshire. The term of the lease for our Salem, New
Hampshire facility extends through August 2023. 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 3. 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.
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Item 4. Mine Safety Disclosures.
Not applicable.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information and Holders
Our common stock is traded on the Nasdaq Global Select Market under the symbol “SCPH”.
As of March 21, 2023, there were 24 holders of record of our common stock, which excludes stockholders whose shares were held in
nominee or street name by brokers.
Dividend Policy
We have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available funds and any future
earnings, if any, to fund the development and expansion of our business and we do not anticipate paying any cash dividends in the
foreseeable future. Any future determination to pay cash dividends will be made at the discretion of our board of directors. In addition, the
terms of our outstanding indebtedness restrict our ability to pay cash dividends, and any future indebtedness that we may incur could
preclude us from paying cash dividends.
Securities Authorized for Issuance Under Equity Compensation Plans
Information about our equity compensation plans and the securities authorized for issuance thereunder is set forth in Part III, Item 12 of this
Annual Report on Form 10-K.
Recent Sales of Unregistered Securities
None.
Issuer Purchases of Equity Securities
None.
Item 6. [RESERVED]
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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated
financial statements and the related notes appearing at the end of this Annual Report on Form 10-K. This discussion includes forward-looking
statements that involve risks, uncertainties and assumptions such as our plans, objectives, expectations and intentions. You should read the
“Forward-Looking Statements” and “Risk Factors” sections of this Annual Report on Form 10-K for a discussion of important factors that
could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the
following discussion and analysis.
OVERVIEW
We are 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. Our strategy is designed to enable the subcutaneous administration of
therapies 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 technology 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 on-body infusor, which delivers an 80 mg dose. On October 10, 2022, we announced that the U.S. Food and
Drug Administration, or FDA, approved FUROSCIX for the treatment of congestion due to fluid overload in adults with New York Heart
Association Class II/III chronic heart failure. FUROSCIX is the first and only FDA-approved subcutaneous loop diuretic that delivers IV
equivalent diuresis at home. IV equivalence was established in a clinical study in which FUROSCIX demonstrated 99.6% bioavailability (90%
CI: 94.8%-104.8%) and 8-hour urine output of 2.7 L which was similar to subjects receiving intravenous furosemide. We estimate that there is
a $6.9 billion total market opportunity for FUROSCIX in the United States. The commercial launch of FUROSCIX commenced in the first
quarter of 2023.
We have funded our operations from inception through December 31, 2022 primarily through the sale of shares of our common stock and the
incurrence of debt and, prior to that, through the private placement of our preferred stock. Our first product, FUROSCIX, was approved for
sale in October 2022 and we had not generated any revenue from product sales as of December 31, 2022.
For the years ended December 31, 2021 and 2022, our net losses were $28.0 million and $36.8 million, respectively. We have not been
profitable since inception, and as of December 31, 2022, our accumulated deficit was $226.5 million. We expect to continue to incur net
losses for the foreseeable future as we support the commercialization efforts of FUROSCIX in the United States, including building our sales
and marketing organization, continuing research and development efforts, engaging in scale-up manufacturing and seeking regulatory
approval for new product candidates and enhancements. Our financial results may fluctuate from quarter to quarter and will depend on,
among other factors, the net sales of FUROSCIX, the scope and progress of our research and development efforts and timing of certain
expenses.
COMPONENTS OF OUR RESULTS OF OPERATIONS
Research and Development Expenses
Research and development ("R&D") expenses consist of the cost of engineering, clinical trials, regulatory and medical affairs and quality
assurance associated with developing our proprietary technology and product candidates. R&D expenses consist primarily of:
•
•
•
•
•
employee-related expenses, including salaries, benefits, travel expense and stock-based compensation expense;
cost of outside consultants who assist with technology development, regulatory affairs, clinical trials and medical affairs, and
quality assurance;
cost of clinical trial activities performed by third parties;
cost of pre-approval pharmaceutical batch manufacturing; and
cost of facilities and supplies used for internal research and development and clinical activities.
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We expense R&D costs as incurred. Given the emphasis to date on our approved product FUROSCIX, our R&D expenses have not been
allocated on a program-specific basis. In the future, we expect R&D expenses to increase in absolute dollars as we continue to develop new
products and enhance existing products and technologies. We anticipate that our expenses will increase significantly as we:
•
•
•
•
•
continue to advance our pipeline programs beyond FUROSCIX;
continue our current research and development activity;
seek to identify additional research programs and additional product candidates;
initiate preclinical testing and clinical trials for any product candidates we identify and develop, maintain, expand and protect our
intellectual property portfolio; and
hire additional research, clinical and scientific personnel.
General and Administrative Expenses
General and administrative ("G&A") expenses consist of employee-related expenses, including salaries, benefits, travel expense and stock-
based compensation expense for personnel in executive, finance, commercial, human resources, facility operations and administrative
functions. Other G&A expenses include pre-approval promotional activities, marketing, conferences and trade shows, professional services
fees, including legal, audit and tax fees, insurance costs, general corporate expenses and allocated facilities-related expenses.
With the approval of FUROSCIX, we anticipate that our G&A expenses will increase as we continue to build our corporate and commercial
infrastructure to support the commercial launch of FUROSCIX in the United States.
RESULTS OF OPERATIONS
Comparison of Years Ended December 31, 2021 and 2022
The following table summarizes our results of operations for the years ended December 31, 2021 and 2022 (in thousands):
(in thousands)
Operating expenses:
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income
Interest income
Interest expense
Net loss
YEAR ENDED
DECEMBER 31,
2021
2022
INCREASE
(DECREASE)
$
$
16,039 $
9,784
25,823
(25,823 )
315
49
(2,575 )
(28,034 ) $
15,533 $
20,624
36,157
(36,157 )
1,418
1,203
(3,302 )
(36,838 ) $
(506 )
10,840
10,334
10,334
1,103
1,154
727
8,804
Research and development expenses. R&D expenses decreased $0.5 million to $15.5 million during the year ended December 31, 2022,
compared to $16.0 million during the year ended December 31, 2021. This decrease was primarily attributable to a $2.3 million decrease in
contract services for clinical and medical affairs, a $0.6 million decrease in quality and regulatory consulting costs and a $0.3 million
decrease in device development costs. The decrease was partially offset by a $1.6 million increase in pharmaceutical development costs, a
$0.9 million increase in employee-related costs, and a $0.2 million increase in patent costs.
General and administrative expenses. G&A expenses increased $10.8 million to $20.6 million during the year ended December 31, 2022,
compared to $9.8 million during the year ended December 31, 2021. This increase was primarily attributable to a $6.8 million increase in
employee-related costs, a $3.5 million increase in commercial preparation costs, and a $0.5 million increase in legal and public company
related costs.
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Other income. Other income was $1.4 million for the year ended December 31, 2022, compared to $0.3 million during the year ended
December 31, 2021. The increase in income of $1.1 million was primarily attributable to the fair value adjustment to the derivative liability in
2022.
Interest income. Interest income increased $1.2 million to $1.2 million during the year ended December 31, 2022 compared to $49,000
during the year ended December 31, 2021. This increase was primarily attributable to higher interest rates on and larger investment balances
in our financial instruments during the year ended December 31, 2022.
Interest expense. Interest expense increased $727,000 from the year ended December 31, 2021 to $3.3 million during the year ended
December 31, 2022. This increase was due to higher term loan balances in the fourth quarter of 2022 as a result of the Oaktree Agreement
(as defined below), combined with the amortization of the debt discount associated with the instrument.
LIQUIDITY AND CAPITAL RESOURCES
Overview
We have funded our operations from inception through December 31, 2022 primarily through the sale of shares of our common stock,
through the private placement of our preferred stock and the incurrence of debt. From inception through December 31, 2022, we had
received net cash proceeds of $92.7 million from our initial public offering; $56.7 million from sales of our preferred stock; $48.6 million from
borrowings under our previous term loan with SLR Investment Corp. and Silicon Valley Bank and our current term loan under the Oaktree
Agreement in 2022, net; $13.5 million from sales of convertible notes; $50.2 million from our public offering of common stock in 2020; $46.6
million from our public offering of common stock in 2022; $14.4 million from the sale of common stock in our 2019 at-the-market offering; and
$1.1 million from the sale of common stock in our 2021 at-the-market offering. As of December 31, 2022, we had cash, cash equivalents and
restricted cash of $71.2 million and short-term investments of $47.1 million. Our cash and cash equivalents are maintained at a number of
financial institutions in amounts that may exceed federally insured limits.
On March 23, 2021, we entered into an Open Market Sale Agreement (the "2021 ATM Agreement") with Cowen and Company LLC
("Cowen") to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $50.0 million, through an at-
the-market equity offering program under which Cowen will act as our sales agent. As of December 31, 2022, we had received $1.1 million of
net proceeds from the sale of shares of common stock pursuant to the 2021 ATM Agreement.
On October 13, 2022, we entered into the Oaktree Agreement which established a $100.0 million term loan facility, consisting of (i) $ 50.0
million funded immediately, (ii) $25.0 million that we may borrow in up to two draws on or prior to September 30, 2024 and (iii) $25.0 million
that we may borrow on or prior to December 31, 2024.
We expect to incur substantial additional expenditures in the near future to support our ongoing activities and our commercialization of
FUROSCIX. We believe our existing unrestricted cash is sufficient to fund our operations through at least the next 12 months from the date of
this Annual Report on Form 10-K. We expect our costs and expenses to increase in the future as we continue U.S. commercialization of
FUROSCIX, including the development of a direct sales force, and as we continue to make substantial expenditures on research and
development, including to increase our manufacturing capacity and for conducting clinical trials of our product candidates. In connection with
such development plans and activities, if we determine that we need additional cash resources, we would seek to access such funds either
pursuant to our 2021 ATM Agreement or through a combination of public or private equity offerings or debt financings. Additionally, we
continue to incur additional costs as a result of operating as a public company. Our future capital requirements will depend on many factors,
including:
•
•
•
•
the costs and expenses of establishing our U.S. sales and marketing infrastructure;
the degree of success we experience in commercializing FUROSCIX;
the revenue generated by sales of FUROSCIX and of other product candidates that may be approved;
the pricing and reimbursement of FUROSCIX and of other product candidates that may be approved;
78
•
•
•
•
•
•
the costs, timing and outcomes of clinical trials and regulatory reviews associated with our product candidates;
the emergence of competing or complementary technological developments;
the extent to which FUROSCIX is adopted by the healthcare community;
the number and types of future products we develop and commercialize;
the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-
related claims; and
the extent and scope of our general and administrative expenses.
Additional financing may not be available on a timely basis on terms acceptable to us, or at all. We may raise funds in equity, royalty-based
or debt financings or enter into additional credit facilities in order to access funds for our capital needs. If we raise additional funds through
further issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution in their percentage
ownership of our company, and any new equity securities we issue could have rights, preferences and privileges senior to those of holders of
our common stock. If we raise additional funds through royalty-based financing arrangements, we will likely agree to relinquish rights to
potentially valuable future revenue streams and may agree to covenants that restrict our operations or strategic flexibility. Any debt financing
obtained by us in the future would cause us to incur additional debt service expenses and could include restrictive covenants relating to our
capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and
pursue business opportunities. If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it, we
may terminate or delay the development of one or more of our products, delay clinical trials necessary to market our products, or delay
establishment or expansion of sales and marketing capabilities or other activities necessary to commercialize our products. For example, the
trading prices for our and other biopharmaceutical companies’ securities have been highly volatile as a result of macroeconomic conditions,
developments in our industry and the COVID-19 pandemic. As a result, we may face difficulties raising capital through sales of our securities
and any such sales may be on unfavorable terms. Additionally, our ability to raise capital may be further impacted by global macroeconomic
conditions including, for example, as a result of international political conflict, supply chain issues and rising inflation and interest rates.
Oaktree Loan and Security Agreement
On October 13, 2022 (the "Closing Date"), we entered into a Credit Agreement and Guaranty (the “Oaktree Agreement”) with, among others,
the lenders from time to time party thereto (the “Lenders”) and Oaktree Fund Administration, LLC, in its capacity as administrative agent for
the Lenders (in such capacity, the “Agent”). The Oaktree Agreement establishes a $ 100.0 million term loan facility, consisting of (i) $50.0
million (the “Tranche A Loan”) funded immediately, (ii) $25.0 million (the “Tranche B Loan”) that we may borrow in up to two draws on or prior
to September 30, 2024 and (iii) $25.0 million (the “Tranche C Loan” and, together with the Tranche A Loan and the Tranche B Loan,
collectively, the “Term Loan”) that we may borrow on or prior to December 31, 2024; provided, in the case of the Tranche B Loan and the
Tranche C Loan, that we have achieved certain net sales revenue milestone targets described in the Oaktree Agreement. The Term Loan
has a maturity date of October 13, 2027 (the “Maturity Date”). We used a portion of the proceeds of the Term Loan to prepay all outstanding
loans under our existing credit facility with SLR Investment Corp. and Silicon Valley Bank and intend to use the remainder of the proceeds to
support our commercialization efforts for FUROSCIX and other working capital and general corporate purposes, including the payment of
fees and expenses associated with the Oaktree Agreement.
Borrowings under the Term Loan will bear interest at a rate per annum equal to three-month term Secured Overnight Financing Rate
("SOFR") (subject to a 1.00% floor and a 3.00% cap), plus an applicable margin of 8.75%, payable monthly in arrears. From and after
achieving $100.0 million in trailing 12-month net sales of FUROSCIX, the applicable margin shall be reduced from 8.75% to 8.25% through
the Maturity Date. For the first two years, we may elect to pay up to 3.00% of interest in-kind. We are also permitted to make quarterly
interest-only payments until the third anniversary of the Closing Date, after which we will be required to make quarterly payments of interest,
plus repay 5.00% of the outstanding principal of the Term Loan in quarterly installments until maturity (subject to certain exceptions).
The Oaktree Agreement contains customary representations, warranties and affirmative and negative covenants, including financial
covenants requiring us to (i) maintain certain levels of cash and cash equivalents in accounts
79
subject to a control agreement in favor of the Agent of at least $15.0 million at all times commencing from 30 days after the Closing Date and
increasing to $20.0 million of cash and cash equivalents in such controlled accounts after we borrow the Tranche B Loan and (ii) meet
minimum quarterly net sales revenue targets described in the Oaktree Agreement.
In connection with the Oaktree Agreement, we issued the Lenders warrants to purchase an aggregate of 516,345 shares of our common
stock at an exercise price of $5.40 per share. The warrants are immediately exercisable, and the exercise period will expire 7 years from the
date of issuance.
Prepayments of the loan, in whole or in part, will be subject to a prepayment fee which declines each year until the fourth anniversary date of
the Closing Date, after which no prepayment fee is required. We are also required to pay an exit fee upon any payment or prepayment equal
to 2.0% of the aggregate principal amount of the loans funded under the Oaktree Agreement.
In addition, the Oaktree Agreement contains customary events of default that could cause our indebtedness to become immediately due and
payable. The lenders could declare the Company in default under its debt obligation upon the occurrence of any event that the lenders
interpret as having a material adverse effect as defined under the Oaktree Agreement. Upon the occurrence and for the duration of an event
of default, an additional interest rate equal to 2.0% per annum could apply to all obligations owed under the Oaktree Agreement. Among
other loan covenant requirements, the Oaktree Agreement also requires the Company to provide an audit opinion of its annual financial
statements not subject to any "going concern" or like qualification or exception.
SLR Investment Corp. and Silicon Valley Bank Term Loan
In May 2017, we entered into a loan and security agreement (the “2017 Loan Agreement”), with SLR Investment Corp (f/k/a Solar Capital
Ltd.) and Silicon Valley Bank (together, the “Lenders”), for $10.0 million. The 2017 Loan Agreement had a maturity date of May 1, 2021. Debt
issuance costs for the 2017 Loan Agreement were to be amortized to interest expense over the remaining term of the 2017 Loan Agreement
using the effective-interest method.
In September 2019, we replaced the 2017 Loan Agreement with a new $20.0 million term loan with the Lenders (the “2019 Loan
Agreement”). The restructured four-year term loan facility allowed for an expansion of the 2017 Loan Agreement. Some of the proceeds from
the 2019 Loan Agreement were used to pay off the 2017 Loan Agreement including the final fee of $325,000. The 2019 Loan Agreement
extended the term of the credit facility until September 17, 2023.
The interest rate under the 2019 Loan Agreement was the higher of (i) LIBOR plus 7.95% or (ii) 10.18% and there was an interest-only
period until September 30, 2021. The rate at December 31, 2021 was 10.18%. Pursuant to the 2019 Loan Agreement, we provided a first
priority security interest in substantially all of our assets, including intellectual property, subject to certain exceptions.
We entered into an Exit Agreement in connection with the 2019 Loan Agreement which provided for an aggregate payment of 4% of the loan
commitment, or $800,000, to the lenders upon the occurrence of an exit event (the “Exit Fee”). We paid the Exit Fee during the year ended
December 31, 2020 in conjunction with our public offering, which was deemed to be an exit event pursuant to the Exit Agreement.
The 2019 Loan Agreement allowed us to voluntarily prepay all (but not less than all) of the outstanding principal at any time. A prepayment
premium of 3% or 1% through the one-year anniversary and the two-year anniversary, respectively, would be assessed on the outstanding
principal. After the two-year anniversary, a 0.5% prepayment premium would be assessed on the outstanding principal. A final payment fee
of $500,000 was due upon the earlier to occur of the maturity date or prepayment of such borrowings.
In connection with the Oaktree Agreement, we paid off all unpaid borrowings under the 2019 Loan Agreement on October 13, 2022, including
the $500,000 final fee and a prepayment premium of $46,000.
2021 At-the-Market Issuance Sales Agreement
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On March 23, 2021, we entered into the 2021 ATM Agreement with Cowen with respect to an at-the-market offering program (the "2021 ATM
Program") under which we could offer and sell shares of our common stock (the "2021 ATM Shares"), having an aggregate offering price of
up to $50.0 million through Cowen as our sales agent.
The offering and sale of 2021 ATM Shares are made pursuant to our shelf registration statement on Form S-3, which was declared effective
by the SEC on April 29, 2021 (the “2021 Registration Statement”). We agreed to pay Cowen a commission up to 3.0% of the gross sales
proceeds of such 2021 ATM Shares.
During the year ended December 31, 2022, we sold a total of 181,553 2021 ATM Shares under the 2021 ATM Program, in the open market,
at a weighted average gross selling price of $6.33 per share for net proceeds of $1.1 million.
Sale of Common Stock
In November 2022, we completed an underwritten public offering of 6,620,000 shares of our common stock (the “2022 Offering Shares”),
pursuant to the 2021 Registration Statement. The 2022 Offering Shares were sold at an offering price of $5.25 per share. In addition, a
prefunded warrant to purchase up to 2,905,000 shares of common stock at a purchase price of $5.249 per underlying share was issued as
part of the transaction. Net proceeds of the offering were $46.6 million, after deducting underwriting discounts, commissions and offering
expenses.
CASH FLOWS
The following table summarizes our sources and uses of cash for each of the periods presented:
(in thousands)
Net cash (used in) provided by:
Operating activities
Investing activities
Financing activities
Net increase (decrease) in cash, cash equivalents
and restricted cash
YEAR ENDED
DECEMBER 31,
2021
2022
$
$
(27,151 ) $
32,130
(2,530 )
2,449 $
(34,577 )
(45,859 )
77,229
(3,207 )
Net Cash Used in Operating Activities
During the year ended December 31, 2022, net cash used in operating activities was $34.6 million, consisting primarily of a net loss of $36.8
million and a $0.4 million increase in net operating assets. This was offset by non-cash charges of $2.6 million. The non-cash charges
primarily consisted of stock-based compensation expense, amortization of right-of-use leased assets, the fair value adjustment to the
derivative liability and non-cash interest expense related to amortization of debt discount associated with the 2019 Loan Agreement and
Oaktree Agreement.
During the year ended December 31, 2021, net cash used in operating activities was $27.2 million, consisting primarily of a net loss of $28.0
million and a $2.6 million increase in net operating assets. This was offset by non-cash charges of $3.5 million. The non-cash charges
primarily consisted of stock-based compensation expense, amortization of right-of-use leased assets and non-cash interest expense related
to amortization of debt discount associated with the 2019 Loan Agreement.
Net Cash Provided By (Used in) Investing Activities
During the year ended December 31, 2022, net cash used in investing activities was $45.9 million, consisting primarily of purchases of short-
term investments, net of maturities.
During the year ended December 31, 2021, net cash provided by investing activities was $32.1 million, consisting primarily of maturities of
short-term investments, net of purchases.
Net Cash (Used in) Provided by Financing Activities
During the year ended December 31, 2022, net cash provided by financing activities was $77.2 million, consisting primarily of net proceeds of
$47.3 million from the Oaktree Agreement, $46.6 million from the November 2022
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public offering, net proceeds of $1.1 million from the 2021 ATM Program and $0.2 million in proceeds from stock option exercises and
purchases of shares through the employee stock purchase plan. The proceeds were offset by the $18.0 million payment on the 2019 Loan
Agreement, including the final fee, and $54,000 in tax obligations from the settlement of restricted stock units.
During the year ended December 31, 2021, net cash used in financing activities was $2.5 million, consisting primarily of principal payments
on the 2019 Loan Agreement.
CONTRACTUAL OBLIGATIONS
The following table summarizes our contractual obligations as of December 31, 2022 and the effects that such obligations are expected to
have on our liquidity and cash flows in future periods.
(in thousands)
Operating lease obligations
Term loan
Total
(1)
TOTAL
2023
PAYMENTS DUE BY PERIOD
2024 and 2025
2026 and 2027
After 2027
$
$
606 $
51,000
51,606 $
596 $
—
596 $
10 $
2,500
2,510 $
— $
48,500
48,500 $
—
—
—
(1)
Consists of obligations under multi-year, non-cancelable building and equipment leases for our facilities in Salem, New Hampshire,
and Burlington, Massachusetts. The building leases expire on August 31, 2023 and November 30, 2023, respectively.
We have drawn down an aggregate of $50.0 million from the Oaktree Agreement as of December 31, 2022. Our contractual commitments
under the Oaktree Agreement as of December 31, 2022 consist of an aggregate of $78.3 million in repayment obligations, inclusive of related
interest amounts and final fee in the amount of $1.0 million. See “—Oaktree Loan and Security Agreement” for additional information
regarding the Oaktree Agreement.
We enter into contracts in the normal course of business with clinical trial sites and manufacturing organizations and with vendors for
preclinical studies, research supplies and other services and products for operating purposes. These contracts generally provide for
termination after a notice period, and, therefore, are cancelable contracts and not included in the table above.
Due to the discontinuation of use of our first generation device in 2019, we have received notice of termination costs related to the program.
Certain of our vendors have claimed or billed for additional costs for which we believe we are not obligated. At this time, we have determined
that the possibility of additional costs is remote.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements,
which have been prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. The preparation of these
consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue,
expenses and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are
reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and
liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or
conditions and any such differences may be material.
While our significant accounting policies are more fully described in the notes to our consolidated financial statements appearing elsewhere
in this Annual Report on Form 10-K, we believe the following discussion addresses our most critical accounting policies, which are those that
are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments.
Stock-Based Compensation Expense
We are required to determine the fair value of equity incentive awards and recognize compensation expense for all equity incentive awards,
including employee stock options and restricted stock units. We recognize this
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expense over the requisite service period. In addition, we recognize stock-based compensation expense in the statements of operations
based on awards expected to vest and, therefore, the amount of expense has been reduced for estimated forfeitures. We use the ratable
straight-line method for expense attribution.
The valuation model we used for calculating the fair value of stock options for stock-based compensation expense is the Black-Scholes
option-pricing model, or the Black-Scholes model. The Black-Scholes model requires us to make assumptions and judgments about the
variables used in the calculation, including:
•
•
•
•
•
•
Expected term. We do not believe we are able to rely on our historical exercise and post-vesting termination activity to provide
accurate data for estimating the expected term for use in determining the fair value-based measurement of our options.
Therefore, we have opted to use the “simplified method” for estimating the expected term of options, which is the average of the
weighted-average vesting period and contractual term of the option.
Expected volatility. Due to the lack of a public market for the trading of our common stock prior to our IPO and a lack of
company specific historical volatility, we have determined the share price volatility for options granted based on an analysis of
the volatility of a peer group of publicly traded companies. In evaluating similarity, we consider factors such as stage of
development, risk profile, enterprise value and position within the industry.
Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for zero-
coupon U.S. Treasury notes with remaining terms similar to the expected term of the options.
Dividend rate. We assumed the expected dividend to be zero as we have never paid dividends and have no current plans to do
so.
Expected forfeiture rate. We estimate forfeitures at the time of grant and revise those estimates in subsequent periods if actual
forfeitures differ from those estimates. We use historical data to estimate pre-vesting option forfeitures and record share-based
compensation expense only for those awards that are expected to vest.
Service period. We amortize all stock-based compensation over the requisite service period of the awards, which is generally
the same as the vesting period of the awards. We amortize the stock-based compensation cost on a straight-line basis over the
expected service periods.
Restricted stock units are valued at the fair market value per share of our common stock on the date of grant.
Research and Development Expenses
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued R&D expenses as of each
balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify
services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the
service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly
in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance
sheet date based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service
providers and make adjustments if necessary. The significant estimates in our accrued R&D expenses include the costs incurred for services
performed by our vendors in connection with R&D activities for which we have not yet been invoiced.
We base our expenses related to R&D activities on our estimates of the services received and efforts expended pursuant to quotes and
contracts with vendors that conduct R&D on our behalf. The financial terms of these agreements are subject to negotiation, vary from
contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed
the level of services provided and result in a prepayment of the R&D expense. In accruing service fees, we estimate the time period over
which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or
the level of effort varies from our estimate, we adjust the accrual or prepaid accordingly. Advance payments for goods and services that will
be used in future R&D activities are expensed when the activity has been performed or when the goods have been received rather than
when the payment is made.
83
Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of
services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that are too high or
too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts
actually incurred.
Derivative Liability
We evaluate our financial instruments for embedded features and bifurcate those features from the host instrument that meet the definition of
a derivative if (i) the economic characteristics and risks of the embedded feature are not clearly and closely related to the host instrument, (ii)
the hybrid instrument that embodies both the embedded feature and the host contract is not remeasured at fair value under otherwise
applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (iii) a separate
instrument with the same terms as the embedded feature would be considered a derivative instrument subject to
the accounting requirements of derivative instruments.
We use judgment in determining the fair value of embedded features that are bifurcated from the host instrument and accounted for as
derivative instruments at the date of issuance and at every balance sheet date thereafter. The valuation method used in the determination of
fair value is based on the type of derivative instrument. At each balance sheet date, we remeasure our derivative instruments at fair value
with adjustments to fair value recognized within other income (expense).
In connection with the Oaktree Agreement, we identified a number of derivatives that required bifurcation from the term loan as a compound
derivative liability. The fair value of the embedded derivative liability was estimated using a hybrid between the discounted cash flow and
Monte Carlo simulation methods, which required significant judgement. Assumptions included estimates of volatility, market yield, probability
and timing of change in control, probability and timing of a going concern qualification, and net sales projections. We recorded an initial fair
value of approximately $8.9 million at inception of the Oaktree Agreement and a fair value of $7.5 million as of December 31, 2022. The
change in fair value of $1.3 million between inception and December 31, 2022 was recognized as a gain within other income on our
consolidated statement of operations and comprehensive loss.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risks related to changes in foreign currency exchange rates and interest rates.
We contract with vendors in foreign countries. As such, we have exposure to adverse changes in exchange rates of foreign currencies,
principally the Swiss franc and the EU euro, associated with our foreign transactions. We believe this exposure to be immaterial. We
currently do not hedge against this exposure to fluctuations in exchange rates.
Our exposure to market risk also relates to interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. As
of December 31, 2022, our aggregate outstanding indebtedness was $50.0 million, which bears interest per annum equal to three-month
term SOFR (subject to a 1.00% floor and a 3.00% cap), plus applicable margin of 8.75%. Due to the short-term duration of our indebtedness,
an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our debt instruments.
We do not believe that inflation has had a material effect on our business. However, if our costs, in particular costs related to manufacture
and supply, were to become subject to significant inflationary pressures, it may adversely impact our business, operating results and financial
condition.
84
Item 8. Consolidated Financial Statements and Supplementary Data.
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Financial Statements:
Consolidated Balance Sheets as of December 31, 2021 and 2022
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2021 and 2022
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2021 and 2022
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021 and 2022
Notes to Consolidated Financial Statements
PAGE
86
88
89
90
91
92
85
To the Stockholders and the Board of Directors of scPharmaceuticals Inc.
Report of Independent Registered Public Accounting Firm
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of scPharmaceuticals Inc. and its subsidiary (the Company) as of
December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash
flows for the years then ended, and the related notes to the consolidated financial statements (collectively, the financial statements). In our
opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and
2021, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally
accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the
Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting
Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The
Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our
audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or
fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the
amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was
communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the
financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit
matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical
audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Accounting Assessment and Valuation of Derivative Liability
On October 13, 2022, the Company entered into a $100.0 million term loan consisting of $50.0 million of debt funded immediately with
additional borrowings in up to two draws of $25.0 million each, as described in Notes 9 and 10 to the consolidated financial statements. The
Company concluded that the term loan contained embedded derivatives and determined that the embedded derivatives required bifurcation
as one compound derivative liability. The Company recorded the derivative liability on its consolidated balance sheet at its fair value of
approximately $8.9 million on October 13, 2022 and $7.5 million as of December 31, 2022. The Company also recorded a gain on its
consolidated statement of operations and comprehensive loss of approximately $1.3 million to reflect the change in fair value of the derivative
liability during the year ended December 31, 2022. To estimate the fair value of the derivative liability at both October13, 2022 and December
31, 2022, the Company utilized a combination of a valuation model that discounts forecasted future cash flows expected to be generated and
a valuation model that reflects the use of multiple probabilities.
86
We identified the initial accounting assessment and the valuation of the derivative liability as a critical audit matter because of the complexity
of evaluating the accounting for the embedded derivatives and the complexity of the valuation models, including the judgements made by
management in estimating the fair value of the derivative liability. The valuation models used in determining the fair value of the derivative
liability include inputs subject to management's judgment, including estimates of volatility, market yield, probability of a change of control or
fundamental change, probability of a going concern qualification and net sales projections. This required subjective auditor judgment and an
increased level of effort when performing audit procedures, including the involvement of valuation professionals with specialized skills and
knowledge.
Our audit procedures related to the Company’s evaluation and valuation of the derivative liability included the following, among others:
•
•
•
•
Inspected the terms of all relevant term loan legal documents supporting the transaction and ensured agreement to the source
data used by management in determining the appropriate accounting treatment for the embedded features and the resulting
derivative valuation
Assessed the Company’s technical accounting assessment regarding the existence of embedded derivatives that may require
separate accounting under the applicable accounting guidance
Evaluated significant assumptions used to calculate the fair value of the derivative liability including the estimate of the
probability of a change of control or fundamental change, probability of a going concern qualification and net sales projections
With the assistance of our fair value specialists, we tested the appropriateness of the methodology used in estimating the fair
value of the embedded derivatives, including evaluating the reasonableness of the estimates for volatility and market yield and
tested the mathematical accuracy of the resulting valuations
/s/ RSM US LLP
We have served as the Company's auditor since 2015.
Boston, Massachusetts
March 22, 2023
87
SCPHARMACEUTICALS INC.
Consolidated Balance Sheets
(in thousands, except share and per share data)
DECEMBER 31,
2021
DECEMBER 31,
2022
Assets
Current assets
Cash and cash equivalents
Short-term investments
Restricted cash
Inventory
Prepaid expenses
Deposits and other current assets
Total current assets
Property and equipment, net
Right-of-use lease assets - operating, net
Deposits and other assets
Total assets
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable
Accrued expenses
Term loan, short-term
Lease obligation - operating, short-term
Other current liabilities
Total current liabilities
Term loan, long-term
Derivative liability
Lease obligation - operating, long-term
Other liabilities
Total liabilities
Commitments and contingencies (Note 13)
Stockholders’ Equity
Preferred stock, $0.0001 par value; 10,000,000 shares authorized
and no shares issued and outstanding
Common stock; $0.0001 par value; 150,000,000 shares
authorized at December 31, 2022; 27,366,707 and
34,257,916 shares issued and outstanding at December 31,
2021 and December 31, 2022, respectively
Additional paid-in capital
Accumulated deficit
Accumulated other comprehensive (loss) income
Total stockholders’ equity
Total liabilities and stockholders’ equity
$
$
$
$
74,268 $
1,010
182
—
2,791
24
78,275
69
410
283
79,037 $
544 $
3,995
9,805
476
26
14,846
7,354
—
—
367
22,567
71,061
47,125
182
1,230
2,282
1,428
123,308
54
566
267
124,195
1,518
5,289
—
567
42
7,416
36,794
7,517
7
28
51,762
—
—
3
246,166
(189,698 )
(1 )
56,470
79,037 $
3
298,934
(226,536 )
32
72,433
124,195
The accompanying notes are an integral part of these consolidated financial statements.
88
SCPHARMACEUTICALS INC.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
Operating expenses:
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income
Interest income
Interest expense
Net loss
Net loss per share, basic and diluted
Weighted—average common shares outstanding, basic and
diluted
Other comprehensive loss:
Unrealized (loss) gain on short-term investments
Comprehensive loss
FOR THE YEAR ENDED DECEMBER 31,
2021
2022
$
$
$
$
$
16,039 $
9,784
25,823
(25,823 )
315
49
(2,575 )
(28,034 ) $
(1.02 ) $
15,533
20,624
36,157
(36,157 )
1,418
1,203
(3,302 )
(36,838 )
(1.30 )
27,351,730
28,358,502
(2 ) $
(28,036 ) $
33
(36,805 )
The accompanying notes are an integral part of these consolidated financial statements.
89
SCPHARMACEUTICALS INC.
Consolidated Statements of Stockholders’ Equity
(in thousands, except share data)
COMMON STOCK
ADDITIONA
L
At December 31, 2020
Net loss
Issuance of common stock upon exercise
of stock options
Issuance of common stock purchased through
employee stock purchase plan
Vesting of restricted stock
Stock-based compensation
Unrealized loss on short term investments
At December 31, 2021
Net loss
Issuance of common stock under at-the-market
offering, net of issuance costs (Note 11)
Issuance of common stock and pre-funded warrants in
common stock offering, net of issuance costs (Note 11)
Issuance of common stock upon exercise
of stock options
Issuance of common stock purchased through
employee stock purchase plan
Vesting of restricted stock
Issuance of warrants (Note 11)
Stock-based compensation
Unrealized gain on short term investments
At December 31, 2022
SHARES
AMOUNT
27,325,959
—
2,501
11,253
26,994
—
—
27,366,707
—
181,553
6,620,000
11,756
45,938
31,962
—
—
—
3
—
—
—
—
—
—
3
—
—
—
—
—
—
—
—
—
34,257,916
$
3
$
PAID-IN
CAPITAL
ACCUMULATE
D
DEFICIT
243,830
—
(161,664 )
(28,034 )
9
42
(81 )
2,366
—
—
—
—
—
—
246,166
—
(189,698 )
(36,838 )
1,114
46,645
44
173
(54 )
2,008
2,838
—
298,934 $
—
—
—
—
—
—
—
—
(226,536 ) $
OTHER
COMPREHENSI
VE INCOME
(LOSS)
TOTAL
STOCKHOLDER
S’
EQUITY
1
—
—
—
—
—
(2 )
(1 )
—
—
—
—
—
—
—
—
33
32 $
82,170
(28,034 )
9
42
(81 )
2,366
(2 )
56,470
(36,838 )
1,114
46,645
44
173
(54 )
2,008
2,838
33
72,433
The accompanying notes are an integral part of these consolidated financial statements.
90
SCPHARMACEUTICALS INC.
Consolidated Statements of Cash Flows
(in thousands)
Cash flows from operating activities
Net loss
Adjustments to reconcile net loss to net cash used in
operating activities
Depreciation expense
Amortization expense - right-of-use leased assets -
operating
Accretion on short-term investments
Stock-based compensation
Non-cash interest expense
Fair value adjustment to derivative liability
Changes in operating assets and liabilities
Inventory
Prepaid expenses and other assets
Accounts payable, accrued expenses and other liabilities
Net cash flows used in operating activities
Cash flows from investing activities
Purchases of property and equipment
Maturities of short-term investments
Purchases of short-term investments
Net cash flows provided by (used in) investing activities
Cash flows from financing activities
Proceeds from common stock offering, net of underwriter discounts
and offering costs
Proceeds from at-the-market offering, net
Proceeds from the exercise of stock options
Proceeds from employee stock purchase plan
Proceeds from term loan
Principal payments on term loan
Payment of term loan final fee
Settlement of restricted stock units for tax withholding obligations
Net cash flows (used in) provided by financing activities
Net increase (decrease) in cash
Cash, cash equivalents and restricted cash, beginning of year
Cash, cash equivalents and restricted cash, end of year
Supplemental cash flow information
Interest paid
Taxes paid
Supplemental disclosure of non-cash activities
Transfer of issuance costs from other noncurrent assets to equity
FOR THE YEAR ENDED DECEMBER 31,
2021
2022
$
(28,034 ) $
(36,838 )
34
404
124
2,366
554
—
—
(234 )
(2,365 )
(27,151 )
(9 )
41,150
(9,011 )
32,130
—
—
9
42
—
(2,500 )
—
(81 )
(2,530 )
2,449
72,001
74,450 $
2,043 $
206
—
37
431
(244 )
2,838
884
(1,335 )
(1,230 )
(887 )
1,767
(34,577 )
(21 )
21,700
(67,538 )
(45,859 )
46,645
1,120
44
173
47,301
(17,500 )
(500 )
(54 )
77,229
(3,207 )
74,450
71,243
2,555
190
6
$
$
The accompanying notes are an integral part of these consolidated financial statements.
91
SCPHARMACEUTICALS INC.
Notes to Consolidated Financial Statements
For the Years Ended December 31, 2021 and 2022
1. Description of Business and Basis of Presentation
Description of Business
scPharmaceuticals LLC was formed as a Limited Liability Company under the laws of the State of Delaware on February 19, 2013. On March
24, 2014, scPharmaceuticals LLC was converted to a Delaware Corporation and changed its name to scPharmaceuticals Inc. (“the
Company”). The Company is 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. The Company’s strategy is designed to enable
the subcutaneous administration of therapies that have previously been limited to intravenous (“IV”) delivery. The Company’s headquarters
and primary place of business is Burlington, Massachusetts.
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the
United States (“U.S. GAAP”) and have been prepared on a basis which assumes that the Company will continue as a going concern, which
contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The consolidated
financial statements reflect the operations of the Company and its wholly-owned subsidiary, scPharmaceuticals Securities Corporation. All
significant intercompany balances and transactions have been eliminated in consolidation.
Liquidity
At December 31, 2022, the Company had cash, cash equivalents, restricted cash and investments of $118.4 million and working capital of
$115.9 million. During the year ended December 31, 2022, the Company incurred a net loss totaling $36.8 million and used cash in operating
activities totaling $34.6 million. The Company expects to continue to incur losses and use cash in operating activities in 2023.
In October 2022, the Company entered into a Credit Agreement and Guaranty (the "Oaktree Agreement") with, among others, the lenders
from time to time party thereto (the "Lenders") and Oaktree Fund Administration, LLC, in its capacity as administrative agent for the Lenders
(Note 10). In November 2022, the Company completed an underwritten public offering with net proceeds of $46.6 million (Note 11). In
addition, the Company currently has an at-the-market offering program with Cowen and Company, LLC that has $48.9 million in capacity
remaining at December 31, 2022 (Note 11).
The Company believes that, based on its current development plans and activities, its resources will be sufficient to satisfy its liquidity
requirements for more than one year from the issuance date of these consolidated financial statements.
2. Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and
the reported amounts of expenses during the reporting periods. Significant items subject to such estimates and assumptions include the
determination of fair value of financial instruments, accruals related to development costs and clinical activities, and the establishment of the
tax valuation allowance. Actual results could differ from those estimates.
92
Foreign Currency Transactions
The functional currency of the Company is the U.S. dollar. Accordingly, gains and losses resulting from translating transactions denominated
in currencies and balances of assets and liabilities outstanding at the balance sheet date, other than U.S. dollars, are included in net loss in
the Statements of Operations and Comprehensive Loss.
Cash, Cash Equivalents and Restricted Cash
Cash, cash equivalents and restricted cash consists of bank deposits, certificates of deposit and money market accounts with financial
institutions. Cash equivalents are carried at cost which approximates fair value due to their short-term nature and which the Company
believes do not have a material exposure to credit risk. The Company considers all highly liquid investments with maturities of three months
or less from the date of purchase to be cash equivalents. The Company places its cash and cash equivalents with institutions with high credit
quality. However, at certain times such cash and cash equivalents may be in excess of Federal Deposit Insurance Corporation and Securities
Investor Protection Corporation insurance limits. The Company has not experienced any losses with respect to these accounts.
As of December 31, 2021 and 2022, the Company classified $182,000 as restricted cash related to a letter of credit issued as a security
deposit in connection with the Company’s lease of its corporate office facilities (Note 13). Cash, cash equivalents and restricted cash consists
of the following (in thousands):
Cash and cash equivalents
Restricted cash
Cash, cash equivalents and restricted cash
December 31,
2021
December 31,
2022
$
$
74,268 $
182
74,450 $
71,061
182
71,243
Concentration of Credit Risk
Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents and short-term investments. The
Company maintains its cash and cash equivalent balances with high-quality financial institutions and, consequently, the Company believes
that such funds are subject to minimal credit risk. The Company’s short-term investments consist of commercial paper, United States
Treasury securities and United States Government Agency securities. The Company has adopted an investment policy that limits the
amounts the Company may invest in any one type of investment and requires all investments held by the Company to hold a minimum rating,
thereby reducing credit risk exposure.
Investments
The Company invests excess cash balances in available-for-sale debt securities. The Company determines the appropriate classification of
these securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. The
Company reports available-for-sale investments at fair value at each balance sheet date and includes any unrealized gains and losses in
accumulated other comprehensive income (loss), a component of stockholders’ equity. Realized gains and losses are determined using the
specific identification method and are included in other income (expense). If any adjustment to fair value reflects a decline in the value of the
investment, the Company considers all available evidence to evaluate the extent to which the decline is “other than temporary,” including the
intention to sell and, if so, marks the investment to market through a charge to the Company’s consolidated statements of operations and
comprehensive loss.
Inventory
Inventory is stated at the lower of cost and net realizable value and consists of raw materials, work-in-process and finished goods. The
Company began capitalizing inventory costs following U.S. Food and Drug Administration ("FDA") approval of FUROSCIX on October 7,
2022. Inventory is sold on a first in, first out ("FIFO") basis. The Company periodically reviews inventory for expiry and obsolescence and
writes it down accordingly, if necessary.
93
Prior to FDA approval of FUROSCIX, the Company expensed all inventory-related costs, including that used for clinical development, to
research and development ("R&D") costs in the period incurred.
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use (“ROU”) lease assets,
current portion of lease obligations, and long term lease obligations on the Company’s balance sheets.
ROU lease assets represent the Company’s right to use an underlying asset for the lease term and lease obligations represent the
Company’s obligation to make lease payments arising from the lease. Operating ROU lease assets and obligations are recognized at the
commencement date based on the present value of lease payments over the lease term. As most of the Company’s leases do not provide an
implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining
the present value of lease payments. The ROU lease asset excludes lease incentives. The Company’s lease terms include options to extend
or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is
recognized on a straight-line basis over the lease term.
Debt Issuance Costs
Debt issuance costs are amortized to interest expense using the effective interest rate method over the term of the debt. Debt issuance costs
paid to the lender and third parties are reflected as a discount to the debt in the consolidated balance sheets.
Research and Development Costs
Research and development costs are expensed as incurred. Nonrefundable advance payments, if any, for goods or services used in
research and development are initially recorded as an asset and then recognized as an expense as the related goods are delivered or
services are performed. Research and development expenses include contract services, consulting, salaries, materials and supplies and
overhead.
Income Taxes
The Company accounts for income taxes in accordance with Accounting Standard Codification (“ASC”) 740 Income Taxes (“ASC 740”).
Deferred tax assets and liabilities are recorded to reflect the impact of temporary differences between amounts of assets and liabilities for
financial reporting purposes and such amounts as measured under enacted tax laws. A valuation allowance is required to offset any net
deferred tax assets if, based upon the available evidence, it is more likely than not that some or all of the deferred tax asset will not be
realized.
The Company provides reserves for potential payments of tax to various tax authorities related to uncertain tax positions. The tax benefits
recorded are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is “more
likely than not” to be realized following resolution of any uncertainty related to the tax benefit, assuming that the matter in question will be
raised by the tax authorities. Potential interest and penalties associated with such uncertain tax positions are recorded as a component of
income tax expense. At December 31, 2021 and 2022, the Company had no such accruals.
Stock-Based Compensation
Stock-based compensation expense for stock options is recognized based on the grant-date fair value using the Black-Scholes valuation
model. Restricted stock units are valued at the fair market value per share of the Company’s common stock on the date of grant. The
Company recognizes compensation expense only for those stock-based awards expected to vest after considering expected forfeitures.
Cumulative compensation expense is at least equal to the compensation expense for vested awards. Stock-based compensation is
recognized on a straight-line basis over the service period of each award.
94
Segments
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for
evaluation by the chief operating decision-maker (“CODM”) in making decisions regarding resource allocation and assessing performance.
The Company’s chief executive officer is the CODM, and he uses consolidated financial information in determining how to allocate resources
and assess performance. The Company has determined that it operates in one segment.
Recently Issued Accounting Standards
In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update ("ASU") 2016-13, Financial
Instruments-Credit Losses : Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"), which requires the measurement and
recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment
model with an expected loss methodology, which will result in more timely recognition of credit losses. The ASU will be effective for the
Company's fiscal year beginning January 1, 2023. The Company is currently evaluating the impact of the adoption of ASU 2016-13 and does
not expect adoption to have a material effect on the Company’s consolidated financial statements or disclosures.
3. Net Loss per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding
during the period without consideration of dilutive common stock equivalents. Diluted net loss per share is the same as basic net loss per
common share, since the effects of potentially dilutive securities are anti-dilutive. Basic and diluted weighted average shares of common
stock outstanding for the year ended December 31, 2022 include the weighted average effect of outstanding pre-funded warrants for the
purchase of shares of common stock for which the remaining unfunded exercise price is $0.001 per share.
Dilutive common stock equivalents are comprised of unexercised stock options outstanding under the Company’s equity plan, unexercised
warrants and unvested restricted stock.
The following table sets forth the computation of basic and diluted net loss per share of common stock (in thousands, except shares and per
share data):
Net loss
Weighted—average common shares
outstanding, basic and diluted
Net loss per share, basic and diluted
For the year ended
December 31,
2021
December 31,
2022
(28,034 ) $
(36,838 )
27,351,730
(1.02 ) $
28,358,502
(1.30 )
$
$
The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per
share because their inclusion would be anti-dilutive (in common stock equivalent shares):
Stock options to purchase common stock
Warrants to purchase common stock
Unvested restricted stock
4. Investments
For the year ended
December 31,
2021
December 31,
2022
2,662,752
—
42,250
2,705,002
4,008,177
516,345
—
4,524,522
Cash in excess of the Company’s immediate requirements is invested in accordance with the Company’s investment policy that
primarily seeks to maintain adequate liquidity and preserve capital.
95
A summary of the Company’s available-for-sale classified investments as of December 31, 2021 and 2022 consisted of the following (in
thousands):
Investments - Current:
Corporate debt securities
Total
Investments - Current:
Commercial paper
United States Treasury securities
United States Government Agency securities
Total
At December 31, 2021
Accumulated
Unrealized
Gains
Accumulated
Unrealized
Losses
Fair Value
Cost Basis
$
$
1,011 $
1,011 $
- $
- $
(1 ) $
(1 ) $
1,010
1,010
At December 31, 2022
Accumulated
Unrealized
Gains
Accumulated
Unrealized
Losses
Cost Basis
$
$
16,741 $
15,768
14,584
47,093 $
- $
7
25
32 $
- $
-
-
- $
Fair Value
16,741
15,775
14,609
47,125
The amortized cost and fair value of the Company’s available-for-sale investments, by contract maturity, as of December 31, 2022 consisted
of the following (in thousands):
Due in one year or less
Total
5. Inventory
The Company's inventory balance consists of the following (in thousands):
Raw materials
Work-in-process
Finished goods
Amortized Cost
Fair Value
$
$
47,093 $
47,093 $
47,125
47,125
As of December 31,
2021
2022
—
—
—
—
$
$
1,201
29
—
1,230
$
$
Inventory is stated at the lower of cost and net realizable value and consists of raw materials, work-in-process and
finished goods. The Company began capitalizing inventory costs following FDA approval of FUROSCIX in October 2022 and has not
recorded any significant inventory write-downs since that time. The Company currently uses a limited number of third-party contract
manufacturing organizations ("CMOs") to produce its inventory.
6. Property and Equipment
Purchased property and equipment consist of the following as of December 31, 2021 and 2022 (in thousands):
Office equipment
Office furniture
Computer equipment
Leasehold improvements
Less: Accumulated depreciation
Property and equipment, net
ESTIMATED
USEFUL LIFE
5 years
7 years
3 years
Life of lease
$
$
2021
2022
10 $
126
8
95
239
(170 )
69 $
6
126
15
95
242
(188 )
54
Depreciation expense for the years ended December 31, 2021 and 2022 was $34,000 and $37,000, respectively.
96
7. Accrued Expenses
Accrued expenses at December 31, 2021 and 2022 consist of (in thousands):
Employee compensation and related costs
Contract research and development
Consulting and professional service fees
State taxes
Financing related costs
Interest
Other
Total accrued expenses
2021
2022
1,152 $
2,350
265
5
60
154
9
3,995 $
2,754
1,827
603
49
29
16
11
5,289
$
$
8. Income Taxes
The Company accounts for income taxes in accordance with ASC 740, which requires an asset and liability approach for measuring deferred
taxes based on temporary differences between the financial statement and tax bases of assets and liabilities existing at each balance sheet
date using enacted tax rates for the years in which taxes are expected to be paid or recovered. The tax benefit arising from the Company’s
net loss has been offset by an increase in the valuation allowance.
Accordingly, the Company had no net income tax provision or benefit during the years ended December 31, 2021 and 2022. Components of
the net deferred tax assets at December 31, 2021 and 2022 are as follows (in thousands):
Deferred tax assets:
Federal net operating loss carryforwards
State net operating loss carryforwards
Research and development tax credits
Accrued liabilities
Stock-based compensation
Depreciation and amortization
Capitalized research and development costs
Lease liabilities
Other
Total deferred tax assets
Deferred tax liabilities:
Right-of-use lease assets
Other
Total deferred tax liabilities
Valuation allowance
Net deferred tax assets
97
2021
2022
12,813 $
3,630
3,719
327
1,087
247
29,529
129
29
51,510
(111 )
—
(111 ) $
(51,399 ) $
— $
17,252
4,585
4,214
677
1,329
324
30,976
146
—
59,503
(144 )
(273 )
(417 )
(59,086 )
—
$
$
$
$
At December 31, 2022, the Company had available federal net operating loss carryforwards of $17.5 million, which expire at various dates
through 2037, and $64.6 million, which may be carried forward indefinitely. At December 31, 2022, the Company had available state net
operating loss carryforwards of $72.6 million, which expire at various dates through 2042, and $300,000, which may be carried forward
indefinitely. In assessing the realizability of net deferred tax assets, management considers whether it is more likely than not that the net
deferred tax assets will be realized. The ultimate realization of net deferred tax assets is dependent upon the generation of future taxable
income during the periods in which temporary differences representing future deductible amounts become deductible. Management has
established a full valuation allowance against the net deferred tax assets at December 31, 2021 and 2022 since it is more likely than not that
these future tax benefits will not be realized. During 2022, the valuation allowance increased by $7.7 million.
At December 31, 2022, the Company had federal and state research and development credit carryforwards of $4.3 million and $1.0 million,
respectively. The net credit carryforwards may be used to offset future income taxes and expire at various dates through 2042. Changes in
the Company’s ownership, as defined in the U.S. Internal Revenue Code, may limit the Company’s ability to utilize the tax credit and net
operating loss carryforwards.
A reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the consolidated
financial statements at December 31, 2021 and 2022 are as follows:
Federal income tax at statutory rate
State income tax, net of federal benefit
Research and development credits
Book compensation related to stock options
Change in income tax rate
Other
Increase in valuation allowance
Effective tax rate
2021
2022
21.00 %
5.97 %
3.16 %
0.03 %
0.45 %
(0.93 )%
(29.68 )%
— %
21.00 %
4.28 %
1.39 %
(0.80 )%
(4.93 )%
(0.09 )%
(20.87 )%
(0.02 )%
The Company files tax returns in the United States, Massachusetts and other states. The tax years 2018 through 2022 remain open to
examination by major taxing jurisdictions to which the Company is subject, which are primarily the United States federal and Massachusetts.
Carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service or state tax
authorities if they have or will be used in a future period. The Company is currently not under examination by the Internal Revenue Service or
any other jurisdictions for any tax years. The Company recognizes both accrued interest and penalties related to unrecognized benefits in
income tax expense. The Company has not recorded any interest or penalties on any unrecognized tax benefits since its inception.
A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands):
Beginning uncertain tax benefits
Prior year - increases
Current year - decreases
Current year - increases
Ending uncertain tax benefits
$
$
2021
2022
774 $
—
—
203
977 $
977
—
—
129
1,106
98
9. Fair Value of Financial Instruments
The FASB ASC Topic, Fair Value Measurements and Disclosures (“ASC 820”), provides a fair value hierarchy, which classifies fair value
measurements based on the inputs used in measuring fair value. Observable inputs are inputs that market participants would use in pricing
the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect
the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on
the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the
reported fair value of the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are
described below:
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the
ability to access at the measurement date.
Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant
inputs are observable, either directly or indirectly.
Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value
measurement and observable.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair
value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for
instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that
is significant to the fair value measurement.
The carrying values of the Company’s cash and restricted cash, prepaid expenses and deposits approximate their fair values due to their
short-term nature. The carrying value of the Company’s term loan payable was considered a reasonable estimate of fair value because the
Company’s interest rate is near current market rates for instruments with similar characteristics.
99
The following tables summarize the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the
level of the fair value hierarchy utilized to determine such fair values (in thousands):
As of December 31, 2021
Quoted Prices
in Active
Markets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
TOTAL
Assets:
Cash equivalents
Total cash equivalents
Corporate debt securities
Investments
$
72,449 $
72,449
72,449 $
72,449
— $
—
1,010
1,010
—
—
1,010
1,010
Total
$
73,459 $
72,449 $
1,010 $
—
—
—
—
—
As of December 31, 2022
Quoted Prices
in Active
Markets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
TOTAL
Assets:
Cash equivalents
Total cash equivalents
Commercial Paper
United States Treasury securities
United States Government Agency securities
Investments
Total
Liabilities:
Derivative liability
Total
$
$
$
$
65,875 $
65,875
65,875 $
65,875
— $
—
16,741
15,775
14,609
47,125
—
15,775
—
15,775
16,741
—
14,609
31,350
113,000 $
81,650 $
31,350 $
—
—
—
—
—
—
—
7,517 $
7,517 $
— $
— $
— $
7,517
— $
7,517
Changes in the fair value of the Company’s Level 3 derivative liability for the year ended December 31, 2022 are as follows:
At December 31, 2021
Initial fair value of derivative liability
Change in fair value of derivative liability
At December 31, 2022
$
$
—
8,852
(1,335 )
7,517
The Oaktree Agreement contains embedded derivatives requiring bifurcation as a derivative instrument. The derivative liability related to the
term loan is recorded and accounted for separately in the consolidated financial statements as one compound derivative liability, see Note 10
for additional details. The fair value of the embedded derivative liabilities associated with the term loan was estimated using a hybrid between
the discounted cash flow and Monte Carlo simulation methods. This involves significant Level 3 inputs and assumptions including (i) the
estimated probability and timing of a change in control and (2) the probability-weighted net sales of FUROSCIX.
100
A summary of quantitative information about significant unobservable inputs (Level 3 inputs) used in measuring the Company's derivative
liability that are categorized within Level 3 of the fair value hierarchy is as follows:
Net sales discount rate
Net sales volatility
Risk-free rate
Recovery rate
10. Debt
October 13,
2022
23.3%
80.0%
4.2%
80.0%
December 31,
2022
22.3%
80.0%
4.0%
80.0%
The following table presents the carrying value of the Company's debt balance as of December 31, 2021 and 2022 (in thousands):
Face value of term loans
Unamortized debt discount
Total debt, net
Less: short-term debt
Long-term debt
Oaktree Agreement
DECEMBER 31,
2021
DECEMBER 31,
2022
$
$
$
17,500 $
(341 )
17,159 $
(9,805 )
7,354 $
50,000
(13,206 )
36,794
—
36,794
On October 13, 2022 (“Closing Date”), the Company entered into a Credit Agreement and Guaranty (the “Oaktree Agreement”) with Oaktree
Fund Administration, LLC as administrative agent, and the lenders party thereto (collectively “Oaktree”) to borrow up to $100.0 million in
three tranches with a maturity date of October 13, 2027.
The first tranche of $50.0 million was drawn immediately, with $9.8 million of the proceeds used to repay in full the outstanding loan and fees
under the 2019 Loan Agreement with SLR Investment Corp. and Silicon Valley Bank and $2.7 million in fees and expenses incurred in
connection with the financing, leaving $37.5 million in available proceeds from the first tranche. The ability to draw the remaining $50.0
million is contingent upon reaching certain net sales revenue milestone targets prior to September 30, 2024 and December 31, 2024,
respectively.
The term loan initially bears interest at the three-month term Secured Overnight Financing Rate (“SOFR”) plus an applicable margin of 8.75%
(with a SOFR floor of 1.00% and a 3.00% cap). Once FUROSCIX achieves at least $100.0 million in trailing 12-month net sales, the
applicable margin will step down to 8.25%. The Company is required to make quarterly interest-only payments until the third anniversary of
the Closing Date, after which the Company is required to make quarterly amortizing payments, with the remaining balance of the principal
plus accrued and unpaid interest due at maturity.
In connection with entering into the Oaktree Agreement, the Company granted warrants to Oaktree to purchase up to an aggregate of
516,345 shares of the Company’s common stock at an exercise price of $5.40 per share. Upon inception, the Company evaluated the
warrants and determined that they met all the requirements for equity classification under ASC 815. This transaction was accounted for as a
detachable warrant at its fair value, using the relative fair value method, which is based on a number of unobservable inputs and is recorded
as an increase to additional paid-in-capital on the consolidated statement of stockholder’s equity. The relative fair value of the warrants, $2.0
million, was reflected as a discount to the term loan and will be amortized over the life of the term loan using the effective interest method.
The Company used the Black-Scholes option pricing model to determine the fair value of the warrants. Assumptions included the fair market
value per share of common stock on the valuation date of $5.50, the exercise price per warrant equal to $5.40, the expected volatility of 77%,
the risk-free interest rate of 4.11%, the expected term of 7 years and the absence of a dividend. The warrants are immediately exercisable
and the exercise period expires on October 13, 2029.
The Company identified a number of embedded derivatives that require bifurcation from the term loan and that were separately accounted for
in the consolidated financial statements as one compound derivative liability. Certain of these embedded features include contingent interest
rate reset upon event of default, contingent put options, including change in control and going concern provisions, and additional costs as a
result of changes in
101
law. These embedded features met the criteria requiring these to be bifurcated because they were not clearly and closely related to the host
instrument in accordance with ASC 815-15 and the derivative liability is presented separately in the condensed consolidated balance sheet
as of December 31, 2022. The fair value of the embedded derivative liabilities associated with the term loan was estimated using a hybrid
between the discounted cash flow and Monte Carlo simulation methods. This involves significant Level 3 inputs and assumptions including
an estimated probability and timing of a change in control. The Company re-evaluates this assessment each reporting period and any
changes in estimated fair value is recorded as other income (expense). The initial recognition of the embedded derivative liability upon
issuance of the Term Loan was $8.9 million. At December 31, 2022, the fair value of the embedded derivative liability was $7.5 million.
In connection with the issuance of the term loan, the Company recorded a debt discount of $13.6 million, inclusive of debt issuance costs, the
derivative liability and the relative fair value of the warrants. The discount will be amortized over the life of the term loan using the effective
interest method. For the year ended December 31, 2022, the Company recorded $383,000 related to the amortization of the debt discount
associated with the Oaktree Agreement.
Prepayments of the term loan, in whole or in part, will be subject to a prepayment fee which declines each year until the fourth anniversary
date of the Closing Date, after which no prepayment fee is required. The Company is also required to pay an exit fee upon any payment or
prepayment equal to 2.0% of the aggregate principal amount of the loans funded under the Oaktree Agreement. The Company recorded an
additional debt discount of $1.0 million related to the exit fee. For the year ended December 31, 2022, the Company recorded $28,000
related to the amortization of the exit fee associated with the Oaktree Agreement.
The Oaktree Agreement contains customary representations, warranties and affirmative and negative covenants, including financial
covenants requiring the Company to (i) maintain unrestricted cash of at least $15.0 million at all times, increasing to $20.0 million upon
accessing the second tranche of the term loan and (ii) meet minimum quarterly net sales revenue targets.
In addition, the Oaktree Agreement contains customary events of default that could cause the Company’s indebtedness to become
immediately due and payable. The lenders could declare the Company in default under its debt obligation upon the occurrence of any event
that the lenders interpret as having a material adverse effect as defined under the Oaktree Agreement. Upon the occurrence and for the
duration of an event of default, an additional interest rate equal to 2.0% per annum could apply to all obligations owed under the Oaktree
Agreement. Among other loan covenant requirements, the Oaktree Agreement also requires the Company to provide an audit opinion of its
annual financial statements not subject to any "going concern" or like qualification or exception.
SLR Investment Corp. and Silicon Valley Bank Term Loan
In May 2017, the Company entered into a loan and security agreement (the “2017 Loan Agreement”), with SLR Investment Corp. (f/k/a Solar
Capital Ltd.) and Silicon Valley Bank, (together, the “Lenders”) for $10.0 million. The 2017 Loan Agreement had a maturity date of May 1,
2021. Debt issuance costs for the 2017 Loan Agreement were to be amortized to interest expense over the remaining term of the 2017 Loan
Agreement using the effective-interest method.
In September 2019, the Company replaced the 2017 Loan Agreement with a new $20.0 million term loan with the Lenders (the "2019 Loan
Agreement"). The restructured four-year term loan facility allowed for an expansion of the 2017 Loan Agreement. Some of the proceeds from
the 2019 Loan Agreement were used to pay off the 2017 Loan Agreement including the final fee of $325,000. The 2019 Loan Agreement
extended the term of the credit facility until September 17, 2023. The payoff of the 2017 Loan Agreement was treated as a modification of
the debt. Debt issuance costs for the 2019 Loan Agreement, including unamortized issuance costs for the 2017 Loan Agreement, would be
amortized to interest expense over the remaining term of the 2019 Loan Agreement using the effective-interest method.
The interest rate under the 2019 Loan Agreement was the higher of (i) LIBOR plus 7.95% or (ii) 10.18% and there was an interest-only
period until September 30, 2021. The rate at December 31, 2022 was 10.18%. Pursuant to the 2019 Loan Agreement, the Company
provided a first priority security interest in substantially all of the Company’s assets, including intellectual property, subject to certain
exceptions.
102
The Company entered into the Exit Agreement in connection with the 2019 Loan Agreement which provided for an aggregate payment of 4%
of the loan commitment, or $800,000, to the Lenders upon the occurrence of an exit event (the "Exit Fee"). The Company concluded that the
exit payment obligation met the definition of a derivative that was required to be accounted for as a separate unit of accounting. The
Company recorded the issuance-date fair value of the derivative liability of $763,000 as a debt discount and as a derivative liability in the
Company’s balance sheet. The derivative liability was re-measured at each balance sheet date and any changes in estimated fair value was
recorded as other income (expense). The Company paid the Exit Fee during the year ended December 31, 2020 in conjunction with the
Company’s public offering, which was deemed to be an exit event pursuant to the Exit Agreement. Prior to its public offering in 2020, the
Company recorded $30,000 in non-cash expense as a fair value adjustment to the derivative liability.
The 2019 Loan Agreement allowed the Company to voluntarily prepay all (but not less than all) of the outstanding principal at any time. A
prepayment premium of 3% or 1% through the one-year anniversary and the two-year anniversary, respectively, would be assessed on the
outstanding principal. After the two-year anniversary, a 0.5% prepayment premium would be assessed on the outstanding principal. A final
payment fee of $500,000 was due upon the earlier to occur of the maturity date or prepayment of such borrowings.
In connection with the Oaktree Agreement, the Company paid off all unpaid borrowings under the 2019 Loan Agreement on October 13,
2022, including the $500,000 final fee and a prepayment premium of $46,000. For the years ended December 31, 2021, and 2022, the
Company recorded $392,000 and $341,000, respectively, related to the amortization of the debt discount associated with the 2019 Loan
Agreement. For the years ended December 31, 2021, and 2022, the Company recorded $162,000 and $132,000 related to the amortization
of the final payment fee associated with the 2019 Loan Agreement.
As of December 31, 2022, future principal payments due under the Oaktree Agreement are as follows (in thousands):
Year ended:
December 31, 2023
December 31, 2024
December 31, 2025
December 31, 2026
December 31, 2027
Total minimum principal payments
$
$
-
-
2,500
10,000
37,500
50,000
11. Stockholders’ Equity
Common Stock
At December 31, 2021 and 2022, the Company had 150,000,000 shares of common stock authorized with a par value of $0.0001. There
were 27,366,707 and 34,257,916 shares issued and outstanding at December 31, 2021 and 2022, respectively. Voting, dividend and
liquidation rights of the holders of the common stock are subject to the Company’s articles of incorporation, corporate bylaws and underlying
shareholder agreements.
Reserved Shares
The Company has reserved 4,008,177 shares of common stock for the exercise of outstanding options to purchase common stock.
2021 At-the-Market Issuance Sales Agreement
On March 23, 2021, the Company entered into an Open Market Sale AgreementSM (the “2021 ATM Agreement”) with Cowen and Company,
LLC (“Cowen”) with respect to an at-the-market offering program (the “2021 ATM Program”) under which the Company could offer and sell
shares of its common stock (the “2021 ATM Shares”), having an aggregate offering price of up to $50.0 million through Cowen as its sales
agent. The offering and sale
103
of 2021 ATM Shares are made pursuant to the Company’s shelf registration statement on Form S-3, which was declared effective by the
SEC on April 29, 2021 (the “2021 Registration Statement”).
The Company agreed to pay Cowen a commission up to 3.0% of the gross sales proceeds of such 2021 ATM Shares. The Company
incurred $273,000 of legal, accounting, and other costs to establish and activate the 2021 ATM Program.
During the year ended December 31, 2022, the Company sold a total of 181,553 2021 ATM Shares under the 2021 ATM Agreement, in the
open market, at a weighted average gross selling price of $6.33 per share for net proceeds of $1.1 million. The Company charged $6,000 in
costs related to establishing and activating the program against additional paid in capital upon issuance of shares in 2022.
Sale of Common Stock
In November 2022, the Company completed an underwritten public offering of 6,620,000 shares of its common stock (the “2022 Offering
Shares”), pursuant to the 2021 Registration Statement. The 2022 Offering Shares were sold at an offering price of $5.25 per share. In
addition, a prefunded warrant to purchase up to 2,905,000 shares of common stock at a purchase price of $5.249 per underlying share was
issued as part of the transaction. The pre-funded warrants were accounted for as equity instruments. Net proceeds of the offering were $46.6
million, after deducting underwriting discounts, commissions and offering expenses.
Preferred Stock
At December 31, 2021 and 2022, the Company had 10,000,000 shares of preferred stock authorized with a par value of $0.0001 and no
shares of preferred stock were issued or outstanding.
12. Stock-Based Compensation
Stock Options
In October 2017, the board of directors approved the 2017 Stock Option and Incentive Plan (the “2017 Stock Plan”) which became effective
in November 2017, upon the closing of the Company’s IPO. The 2017 Stock Plan will expire in October 2027. Under the 2017 Stock Plan,
the Company may grant incentive stock options, non-statutory stock options, restricted stock awards, RSUs and other stock-based awards.
The Company’s 2014 Stock Incentive Plan (the “2014 Stock Plan”) terminated in November 2017 effective upon the completion of the
Company’s IPO. No additional options will be granted under the 2014 Stock Plan. At December 31, 2022, there were 598,411 options
outstanding under the 2014 Stock Plan.
At December 31, 2022, there were 6,105,147 shares of the Company’s common stock authorized for issuance under the 2017 Stock Plan,
including 359,860 options that have been forfeited from the 2014 Stock Plan.
At December 31, 2022, there were 2,655,289 options available for issuance and 3,409,766 options outstanding under the 2017 Stock Plan.
Awards granted under the 2017 Stock Plan have a term of ten years. Vesting of awards under the 2017 Stock Plan is determined by the
compensation committee of the board of directors but is generally over one to four-year terms.
The fair value of options at date of grant was estimated using the Black-Scholes option-pricing model with the following assumptions:
Risk-free interest rate
Expected dividend yield
Expected life
Expected volatility
Weighted-average grant date
fair value
2021
0.50%—1.25%
0%
5.5—6.7 years
72%—74%
2022
1.67%—4.18%
0%
5.5—6.7 years
70%—84%
$
4.18 $
3.18
104
Due to the lack of a public market for the trading of the Company’s common stock prior to its initial public offering and the lack of company-
specific historical volatility, volatility was estimated using historical volatilities of similar companies. The expected life of the awards is
estimated based on the simplified method, which calculates the expected life based upon the midpoint of the term of the award and the
vesting period. The Company uses the simplified method because it does not have sufficient option exercise data to provide a reasonable
basis upon which to estimate the expected term. The Company has no history of paying dividends nor does management expect to pay
dividends over the contractual terms of these options. The risk-free interest rates are based on the United States Treasury yield curve in
effect at the time of grant, with maturities approximating the expected life of the stock options.
The following table summarizes information about stock option activity during 2021 and 2022 (in thousands, except share and per share
data):
Outstanding, December 31, 2020
Granted
Exercised
Forfeited
Outstanding, December 31, 2021
Granted
Exercised
Forfeited
Outstanding, December 31, 2022
Vested and exercisable, December 31, 2022
Vested and expected to vest, December 31, 2022
WEIGHTED-
AVERAGE
EXERCISE
PRICE
WEIGHTED-
AVERAGE
REMAINING
CONTRACT
UAL
TERM
AGGREGATE
INTRINSIC
VALUE
NUMBER OF
SHARES
2,224,913 $
953,506
(2,501 )
(513,166 )
2,662,752 $
1,455,594
(11,756 )
(98,413 )
4,008,177 $
1,982,329 $
3,489,134 $
6.26
6.57
3.81
6.72
6.28
4.86
3.71
6.73
5.76
6.15
5.81
7.47 $
6.01 $
7.25 $
7,147
3,436
6,226
The following table summarizes information about RSU activity during 2021 and 2022:
RSUs outstanding, December 31, 2020
Granted
Vested
Forfeited
RSUs outstanding, December 31, 2021
Granted
Vested
Forfeited
RSUs outstanding, December 31, 2022
105
AVERAGE GRANT
DATE FAIR VALUE
(IN DOLLARS PER
SHARE)
RSUs
80,450 $
—
(38,200 )
—
42,250
—
(42,250 )
—
— $
3.25
—
3.25
—
3.25
—
3.25
—
—
The number of RSUs vested includes shares of common stock withheld on behalf of employees to satisfy the minimum statutory tax
withholding requirements.
During 2021 and 2022, the Company received $9,000 and $44,000, respectively, upon exercise of stock options. The intrinsic value of the
options exercised in 2021 and 2022 was $7,000 and $18,000, respectively.
Unrecognized compensation expense related to unvested options as of December 31, 2022 was $4.2 million and will be recognized over the
remaining vesting periods of the underlying awards. The weighted-average period over which such compensation is expected to be
recognized is 2.5 years.
Employee Stock Purchase Plan
In October 2017, the board of directors approved the 2017 Employee Stock Purchase Plan (“the ESPP”) which became effective in
November 2017, upon the closing of the Company’s IPO. As part of the ESPP, eligible employees may acquire an ownership interest in the
Company by purchasing common stock, at a discount, through payroll deductions. Eligible employees who elected to participate were able to
participate in the ESPP beginning September 1, 2021.
During 2021 and 2022, 11,253 and 45,938 shares of common stock were issued under the ESPP, respectively. As of December 31, 2022,
there were 1,142,691 shares of common stock available for issuance under the ESPP.
The Company recorded stock-based compensation expense in the following expense categories of its accompanying condensed
consolidated statements of operations and comprehensive loss for employees, directors and non-employees during the years ended
December 31, 2021 and 2022 as follows (in thousands):
Research and development
General and administrative
Total
13. Commitments and Contingencies
Operating Leases
2021
2022
$
$
947 $
1,419
2,366 $
1,050
1,788
2,838
The Company entered into noncancelable operating leases for office facilities located in Lexington, Massachusetts and Burlington,
Massachusetts through December 31, 2022 and November 30, 2023, respectively. Rent expense under the operating leases totaled $0.5
million and $0.5 million for the years ended December 31, 2021 and 2022, respectively.
Certain leases provide for increases in future minimum annual rental payments as defined in the lease agreements. The leases generally
also include real estate taxes and common area maintenance charges in the annual rental payments.
Pursuant to the terms of its lease agreement for the Company’s headquarters in Burlington, Massachusetts, the Company obtained a letter of
credit in the amount of approximately $182,000 as security on the lease obligation. The letter of credit is listed as restricted cash on the
Company’s consolidated balance sheets.
Short-term leases are leases having a term of twelve months or less. The Company recognizes short-term leases on a straight-line basis and
does not record a related lease asset or liability for such leases.
The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as
of December 31, 2022 (in thousands):
106
Year ended:
December 31, 2023
December 31, 2024
December 31, 2025
Total minimum lease payments
Less imputed interest
Total
Lease cost:
Operating lease cost
Short-term lease cost
Sublease income
Total lease cost
Other information
Cash paid for amounts included in the
measurement of liabilities
Operating cash flows from operating leases
Weighted-average remaining lease term -
operating leases
Weighted-average discount rate -
operating leases
$
$
596
9
1
606
(32 )
574
2021
2022
$
$
$
$
482 $
20
(51 )
451 $
530 $
(60 ) $
505
37
(47 )
495
551
(57 )
0.9 years
0.9 years
10.1 %
10.1 %
In July 2021, the Company signed a lease agreement for a new office facility located in Salem, New Hampshire. The lease commenced on
September 1, 2021 and had an initial term of 12 months with an optional extension term through August 2023. In June 2022, the Company
exercised the lease option. The lease is considered short-term and is being recognized on a straight-line basis.
Research and Development Agreements
As part of the Company’s research and development efforts, the Company enters into research and development agreements with unrelated
companies. These agreements contain varying terms and provisions which include fees and milestones to be paid by the Company. Some of
these agreements also contain provisions which require the Company to make payments for exclusivity in the development of products in the
area of loop diuretics.
Contingencies
The Company follows subtopic 450-20 of the FASB ASC to report accounting for contingencies.
Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to the Company but which will only
be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment
inherently involves an exercise of judgment.
If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be
estimated, then the estimated liability would be accrued in the Company’s financial statements. If the assessment indicates that a potential
material loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent
liability, and an estimate of the range of possible losses, if determinable and material, would be disclosed. Loss contingencies considered
remote are generally not disclosed unless they involve guarantees, in which case the guarantees would be disclosed.
Due to the discontinuation of use of the first generation device in 2019, the Company has received notice of termination costs related to the
program. Certain of the Company’s vendors have claimed or billed for additional costs for which the Company believes it is not obligated.
The Company has evaluated this contingent liability in accordance with ASC 450, Contingencies, and determined that the possibility of
additional costs is remote and no longer probable.
107
14. 401(k) Savings Plan
In July 2014, the Company established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code covering all of
its employees. Employees may make contributions by withholding a percentage of their salary. The plan includes an employer match equal to
100% on the first 3% of deferred compensation and an additional 50% on the next 2% of deferred compensation. During the years ended
December 31, 2021 and 2022, the Company has recognized compensation expense of $198,000 and $340,000, respectively, for the
employer match contribution.
15. Subsequent Events
The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to
provide additional evidence relative to certain estimates or to identify matters that require additional disclosure.
In the period beginning January 1, 2023 through the date of this Annual Report on Form 10-K, the Company issued and sold an additional
1,511,157 shares of its common stock under the 2021 ATM Agreement at a weighted average gross selling price of $9.30 per share for net
proceeds of $13.7 million.
On February 1, 2023, the Board of Directors of the Company adopted the 2023 Employment Inducement Award Plan (the "Inducement
Plan") and, subject to the adjustment provisions of the Inducement Plan, reserved 500,000 shares of the Company’s Common Stock for
issuance pursuant to equity awards granted under the Inducement Plan.
108
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design
of disclosure controls and procedures must reflect the fact that there are resource constraints, and that management is required to apply
judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive and financial officer, evaluated, as of the end of the period covered by this
Annual Report on Form 10-K, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Exchange Act). Based on that evaluation of our disclosure controls and procedures as of December 31, 2022, our principal
executive and financial officer concluded that our disclosure controls and procedures as of such date are effective at the reasonable
assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in
Rule 13a-15(f) and 15d-15(f) under the Exchange Act. Our management assessed the effectiveness of our internal control over financial
reporting as of the end of the period covered by this Annual Report on Form 10-K. In making this assessment, management used the criteria
set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013
framework). Based on its assessment, management concluded that, as of December 31, 2022, our internal control over financial reporting
was effective based on those criteria.
Attestation Report of the Independent Registered Public Accounting Firm
This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm because we are a non-
accelerated filer.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or
15d-15(d) of the Exchange Act during the quarter ended December 31, 2022 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
109
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Certain information relating to our executive officers and directors is included in Part I, Item 1, of this Annual Report on Form 10-K. The
remaining information with respect to this item will be contained in our definitive proxy statement to be filed with the SEC in connection with
the 2023 Annual Meeting of Stockholders within 120 days after the conclusion of our fiscal year ended December 31, 2022, or the Proxy
Statement, and is incorporated in this Annual Report on Form 10-K by reference.
Item 11. Executive Compensation.
The information required by this item will be contained in the Proxy Statement and is incorporated in this Annual Report on Form 10-K by
reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this item will be contained in the Proxy Statement and is incorporated in this Annual Report on Form 10-K by
reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item will be contained in the Proxy Statement and is incorporated in this Annual Report on Form 10-K by
reference.
Item 14. Principal Accounting Fees and Services.
Our independent public accounting firm is RSM US LLP, Boston, MA, PCAOB Auditor ID 49.
The information required by this item will be contained in the Proxy Statement and is incorporated in this Annual Report on Form 10-K by
reference.
110
Item 15. Exhibits, Financial Statement Schedules.
(a) Documents filed as a part of this Report:
PART IV
(1) Consolidated Financial Statements—Included in Item 8 of this Annual Report on Form 10-K.
Report of Independent Registered Public Accounting Firm
Consolidated Financial Statements:
Consolidated Balance Sheets as of December 31, 2021 and 2022
Consolidated Statement of Operations and Comprehensive Loss for the Years Ended December 31, 2021 and 2022
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2021 and 2022
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021 and 2022
Notes to Consolidated Financial Statements
86
88
89
90
91
92
(2) Financial Statement Schedules
All financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the
financial statements or the notes thereto.
(3) Index to Exhibits.
Exhibit
Number
Description
3.1
Second Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the
Registrant’s Current Report on Form 8-K (File No. 001-38293) filed on November 21, 2017)
3.2
Amended and Restated By-laws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report
on Form 8-K (File No. 001-38293) filed on November 21, 2017)
3.3
Amendment No. 1 to the Company’s Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the
Registrant’s Current Report on Form 8-K (File No. 001-38293) filed on June 10, 2020)
3.4
Amendment No. 2 to the Company’s Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the
Registrant’s Current Report on Form 8-K (File No. 001-38293) filed on March 12, 2021)
4.1
Amended and Restated Investors’ Rights Agreement among the Registrant and certain of its stockholders, dated December
22, 2016 (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-
221077) filed on October 23, 2017)
4.2
Form of Warrant, dated October 13, 2022, issued by the Registrant to certain lenders, together with a schedule of warrant
holders (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-38293) filed
on October 14, 2022)
4.3
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File
No. 001-38293) filed on November 23, 2022)
4.4
Description of Registered Securities (incorporated by reference to the Registrant's Annual Report on Form 10-K (File No.
001-38293) filed on March 23, 2021)
10.1#
2014 Stock Incentive Plan, as amended, and forms of award agreements thereunder (incorporated by reference to the
Registrant’s Registration Statement on Form S-1 (File No. 333-221077) on October 23, 2017)
111
10.2#
2017 Stock Option and Incentive Plan and forms of award agreements thereunder (incorporated by reference to the
Registrant’s Registration Statement on Form S-1/A (File No. 333-221077) filed on November 7, 2017)
10.3#
Senior Executive Cash Incentive Bonus Plan (incorporated by reference to the Registrant’s Registration Statement on Form
S-1/A (File No. 333-221077) filed on November 7, 2017)
10.4#
2017 Employee Stock Purchase Plan (incorporated by reference to the Registrant’s Registration Statement on Form S-1/A
(File No. 333-221077) filed on November 7, 2017)
10.5*#
10.6*#
2023 Employment Inducement Award Plan and form of award agreement thereunder
Amended and Restated Non-Employee Director Compensation Policy
10.7#
Form of Indemnification Agreement (incorporated by reference to Exhibit 10.5 to the Registrant’s Registration Statement on
Form S-1/A (File No. 333-221077) filed on November 7, 2017)
10.8
Office Lease Agreement, dated as of June 2, 2017, by and between the Registrant and NEEP Investors Holdings LLC
(incorporated by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form S-1 (File No. 333-221077) filed
on October 23, 2017)
10.9
Amendment No. 1, dated April 11, 2022, to the Office Lease Agreement, dated as of June 2, 2017, by and between the
Registrant and NEEP Investors Holdings LLC (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report
on Form 10-Q (File No. 001-38293) filed on May 16, 2022)
10.10
Credit Agreement and Guaranty, dated October 13, 2022, by and among the Registrant, the subsidiary guarantors from time
to time party thereto, the lenders from time to time party thereto and Oaktree Fund Administration, LLC, as administrative
agent (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-38293) filed on
October 14, 2022)
10.11*#
Amended and Restated Employment Agreement, by and between the Registrant and John H. Tucker
10.12#
Employment Agreement, by and between the Registrant and Rachael Nokes (incorporated by reference to Exhibit 10.9 to the
Registrants Annual Report on Form 10-K (File No. 00138293) filed on March 24, 2020)
10.13†
Development Agreement, by and between the Registrant and West Pharmaceutical Services, Inc., dated January 28, 2019
(incorporated by reference to Exhibit 10.2 to the Registrants Quarterly Report on Form 10-Q (File No. 00138293) filed on
May 8, 2019)
10.14†
Supply Agreement, dated August 15, 2020, by and between West Pharmaceutical Services, Inc. and the Registrant
(incorporated by reference to Exhibit 10.1 to the Registrants Quarterly Report on Form 10-Q (File No. 00138293) filed on
November 16, 2020)
21.1
Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to the Registrant's Annual Report on Form 10-K (File
No. 001-38293) filed on March 22, 2022)
23.1*
31.1*
Consent of RSM US LLP, Independent Registered Public Accounting Firm
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of
1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of
1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
32.2**
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
101.INS*
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags
are embedded with the Inline XBRL document
112
101.SCH*
Inline XBRL Taxonomy Extension Schema Document
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in
Exhibits 101.*)
* Filed herewith.
† Portions of this exhibit have been omitted. Certain identified information has been excluded from the exhibit because it is both (i) not
material and (ii) would be competitively harmful if publicly disclosed.
# Indicates a management contract or any compensatory plan, contract or arrangement.
** This certification will not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that
section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or
the Exchange Act, except to the extent specifically incorporated by reference into such filing.
Item 16. Form 10-K Summary.
Not applicable.
113
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused
this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
SCPHARMACEUTICALS INC.
Date: March 22, 2023
By:
/s/ John H. Tucker
John H. Tucker
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following
persons on behalf of the Registrant in the capacities and on the dates indicated.
Name
Title
Date
/s/ John H. Tucker
John H. Tucker
/s/ Rachael Nokes
Rachael Nokes
/s/ Jack A. Khattar
Jack A. Khattar
Director, President, and Chief Executive Officer (Principal Executive
Officer)
March 22, 2023
Chief Financial Officer (Principal Financial and Accounting Officer)
March 22, 2023
Chairman of the Board
March 22, 2023
/s/ Mette Kirstine Agger
Mette Kirstine Agger
Director
/s/ Sara Bonstein
Sara Bonstein
Director
/s/ Minnie V. Baylor-Henry
Minnie V. Baylor-Henry
Director
/s/ Leonard D. Schaeffer
Leonard D. Schaeffer
Director
/s/ Klaus Veitinger, M.D., Ph.D.
Klaus Veitinger, M.D., Ph.D.
Director
/s/ Frederick Hudson
Frederick Hudson
Director
/s/ William T. Abraham, M.D.
William T. Abraham, M.D.
Director
114
March 22, 2023
March 22, 2023
March 22, 2023
March 22, 2023
March 22, 2023
March 22, 2023
March 22, 2023
SCPHARMACEUTICALS INC.
2023 EMPLOYMENT INDUCEMENT AWARD PLAN
Exhibit 10.5
SECTION 1.
GENERAL PURPOSE OF THE PLAN; DEFINITIONS
The name of the plan is the scPharmaceuticals Inc. 2023 Employment Inducement Award Plan (the “Plan”). The purpose of the Plan purpose is
to enhance the ability of scPharmaceuticals Inc. (the “Company”) to attract, retain and motivate persons who are expected to make important contributions
to the Company by providing these individuals with equity ownership opportunities..
The following terms shall be defined as set forth below:
“Act” means the Securities Act of 1933, as amended, and the rules and regulations thereunder.
of the compensation committee.
“Administrator” means either the Board or the compensation committee of the Board or a similar committee performing the functions
“Award” or “Awards,” except where referring to a particular category of grant under the Plan, shall include Non-Qualified Stock
Options, Stock Appreciation Rights, Restricted Stock Units, Restricted Stock Awards, Unrestricted Stock Awards, Cash-Based Awards, Performance Share
Awards and Dividend Equivalent Rights.
under the Plan. Each Award Certificate is subject to the terms and conditions of the Plan.
“Award Certificate” means a written or electronic document setting forth the terms and provisions applicable to an Award granted
“Board” means the Board of Directors of the Company.
“Cash-Based Award” means an Award entitling the recipient to receive a cash-denominated payment.
“Code” means the Internal Revenue Code of 1986, as amended, and any successor Code, and related rules, regulations and
interpretations.
“Director” means a member of the Board.
“Dividend Equivalent Right” means an Award entitling the grantee to receive credits based on cash dividends that would have been
paid on the shares of Stock specified in the Dividend Equivalent Right (or other award to which it relates) if such shares had been issued to and held by the
grantee.
“Effective Date” means the date on which the Plan becomes effective as set forth in Section 21.
”Eligible Individual” means any individual who was not previously an Employee or Director hired as a new Employee or rehired as an
Employee following a bona fide period of interruption of employment if such person is granted an Award as a material inducement to his or her entering
into employment with the Company or a Subsidiary (within the meaning of the NASDAQ Rule 5635(c)(4)).
“Employee” means any employee of the Company or its Subsidiaries.
“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder.
Administrator; provided, however, that if the Stock is admitted to quotation on the
“Fair Market Value” of the Stock on any given date means the fair market value of the Stock determined in good faith by the
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1
National Association of Securities Dealers Automated Quotation System (“NASDAQ”), NASDAQ Global Market or another national securities exchange,
the determination shall be made by reference to market quotations. If there are no market quotations for such date, the determination shall be made by
reference to the last date preceding such date for which there are market quotations; provided further, however, that if the date for which Fair Market Value
is determined is the first day when trading prices for the Stock are reported on a national securities exchange, the Fair Market Value shall be the “Price to
the Public” (or equivalent) set forth on the cover page for the final prospectus relating to the Company’s Initial Public Offering.
the Code.
“Incentive Stock Option” means any Stock Option designated and qualified as an “incentive stock option” as defined in Section 422 of
“Independent Director” means a Director who qualifies as “independent” within the meaning of NASDAQ Rule 5635(c)(4), or any successor
rule, as such rule may be amended from time to time.
“Initial Public Offering” means the first underwritten, firm commitment public offering pursuant to an effective registration statement
under the Act covering the offer and sale by the Company of its equity securities, or such other event as a result of or following which the Stock shall be
publicly held.
authority thereunder, as such rule, guidance and other authority may be amended from time to time.
“NASDAQ Rule 5635(c)(4)” means NASDAQ Rule 5635(c)(4), or any successor rule, and all guidance and other interpretative
“Non-Employee Director” means a member of the Board who is not also an Employee.
“Non-Qualified Stock Option” means any Stock Option that is not an Incentive Stock Option.
“Option” or “Stock Option” means any option to purchase shares of Stock granted pursuant to Section 5.
“Performance Criteria” means the criteria that the Administrator selects for purposes of establishing the Performance Goal or
Performance Goals for an individual for a Performance Cycle. The Performance Criteria (which shall be applicable to the organizational level specified by
the Administrator, including, but not limited to, the Company or a unit, division, group, or Subsidiary of the Company) that will be used to establish
Performance Goals are limited to the following: research and development, publication, clinical and/or regulatory milestones, total shareholder return,
earnings before interest, taxes, depreciation and amortization, net income (loss) (either before or after interest, taxes, depreciation and/or amortization),
changes in the market price of the Stock, economic value-added, sales or revenue, coverage decisions, acquisitions or strategic transactions, operating
income (loss), cash flow (including, but not limited to, operating cash flow and free cash flow), return on capital, assets, equity, or investment, return on
sales, gross or net profit levels, productivity, expense, margins, operating efficiency, customer satisfaction, working capital, earnings (loss) per share of
Stock, sales or market shares and number of customers, any of which may be measured either in absolute terms or as compared to any incremental increase
or as compared to results of a peer group. The Administrator may appropriately adjust any evaluation performance under a Performance Criterion to
exclude any of the following events that occurs during a Performance Cycle: (i) asset write-downs or impairments, (ii) litigation or claim judgments or
settlements, (iii) the effect of changes in tax law, accounting principles or other such laws or provisions affecting reporting results, (iv) accruals for
reorganizations and restructuring programs, and (v) any item of an unusual nature or of a type that indicates infrequency of occurrence, or both, including
those described in the Financial Accounting Standards Board’s authoritative guidance and/or in management’s discussion and analysis of financial
condition of operations appearing the Company’s annual report to stockholders for the applicable year.
“Performance Cycle” means one or more periods of time, which may be of varying and overlapping durations, as the Administrator
may select, over which the attainment of one or more Performance Criteria will be measured for the purpose of determining a grantee’s right to and the
payment of a Restricted Stock Award, Restricted Stock Units, Performance Share Award or Cash-Based Award, the vesting and/or payment of which is
subject to the attainment of one or more Performance Goals.
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Performance Cycle based upon the Performance Criteria.
“Performance Goals” means, for a Performance Cycle, the specific goals established in writing by the Administrator for a
Performance Goals.
“Performance Share Award” means an Award entitling the recipient to acquire shares of Stock upon the attainment of specified
Company’s right of repurchase.
“Restricted Shares” means the shares of Stock underlying a Restricted Stock Award that remain subject to a risk of forfeiture or the
determine at the time of grant.
“Restricted Stock Award” means an Award of Restricted Shares subject to such restrictions and conditions as the Administrator may
at the time of grant.
“Restricted Stock Units” means an Award of stock units subject to such restrictions and conditions as the Administrator may determine
“Sale Event” shall mean (i) the sale of all or substantially all of the assets of the Company on a consolidated basis to an unrelated
person or entity, (ii) a merger, reorganization or consolidation pursuant to which the holders of the Company’s outstanding voting power and outstanding
stock immediately prior to such transaction do not own a majority of the outstanding voting power and outstanding stock or other equity interests of the
resulting or successor entity (or its ultimate parent, if applicable) immediately upon completion of such transaction, (iii) the sale of all of the Stock of the
Company to an unrelated person, entity or group thereof acting in concert, or (iv) any other transaction in which the owners of the Company’s outstanding
voting power immediately prior to such transaction do not own at least a majority of the outstanding voting power of the Company or any successor entity
immediately upon completion of the transaction other than as a result of the acquisition of securities directly from the Company.
stockholders, per share of Stock pursuant to a Sale Event.
“Sale Price” means the value as determined by the Administrator of the consideration payable, or otherwise to be received by
“Section 409A” means Section 409A of the Code and the regulations and other guidance promulgated thereunder.
“Stock” means the Common Stock, par value $0.0001 per share, of the Company, subject to adjustments pursuant to Section 3.
“Stock Appreciation Right” means an Award entitling the recipient to receive shares of Stock having a value equal to the excess of the
Fair Market Value of the Stock on the date of exercise over the exercise price of the Stock Appreciation Right multiplied by the number of shares of Stock
with respect to which the Stock Appreciation Right shall have been exercised.
either directly or indirectly.
“Subsidiary” means any corporation or other entity (other than the Company) in which the Company has at least a 50 percent interest,
“Unrestricted Stock Award” means an Award of shares of Stock free of any restrictions.
SECTION 2.
ADMINISTRATION OF PLAN; ADMINISTRATOR AUTHORITY TO SELECT GRANTEES AND DETERMINE AWARDS
(a)
(b)
Administration of Plan. The Plan shall be administered by the Administrator.
Powers of Administrator. The Administrator shall have the power and authority to grant Awards consistent with the terms of the Plan,
including the power and authority:
(i)
to select the Eligible Individuals to whom Awards may from time to time be granted;
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(ii)
to determine the time or times of grant, and the extent, if any, of Non-Qualified Stock Options, Stock
Appreciation Rights, Restricted Stock Awards, Restricted Stock Units, Unrestricted Stock Awards, Cash-Based Awards, Performance Share Awards and
Dividend Equivalent Rights, or any combination of the foregoing, granted to any one or more grantees;
(iii)
(iv)
to determine the number of shares of Stock to be covered by any Award;
to determine and modify from time to time the terms and conditions, including restrictions, not inconsistent with
the terms of the Plan, of any Award, which terms and conditions may differ among individual Awards and grantees, and to approve the forms of Award
Certificates;
exercised;
(v)
(vi)
(vii)
to accelerate at any time the exercisability or vesting of all or any portion of any Award;
subject to the provisions of Section 5(c), to extend at any time the period in which Stock Options may be
to adopt procedures from time to time that are intended to ensure that an individual is an Eligible Individual prior
to the granting of any Awards to such individual (including without limitation a requirement that each such individual certify to the Company prior to the
receipt of an Award that he or she is not currently employed by the Company or a Subsidiary and, if previously so employed, has had a bona fide period of
interruption of employment, and that the grant of Awards is an inducement material to the Eligible Individual's agreement to enter into employment with
the Company or a Subsidiary); and
(viii)
at any time to adopt, alter and repeal such rules, guidelines and practices for administration of the Plan and for its
own acts and proceedings as it shall deem advisable; to interpret the terms and provisions of the Plan and any Award (including related written
instruments); to make all determinations it deems advisable for the administration of the Plan; to decide all disputes arising in connection with the Plan; and
to otherwise supervise the administration of the Plan.
All decisions and interpretations of the Administrator shall be binding on all persons, including the Company and Plan grantees.
Award Certificate. Awards under the Plan shall be evidenced by Award Certificates that set forth the terms, conditions and limitations
for each Award which may include, without limitation, the term of an Award and the provisions applicable in the event employment or service terminates.
(c)
(d)
Indemnification. Neither the Board nor the Administrator, nor any member of either or any delegate thereof, shall be liable for any
act, omission, interpretation, construction or determination made in good faith in connection with the Plan, and the members of the Board and the
Administrator (and any delegate thereof) shall be entitled in all cases to indemnification and reimbursement by the Company in respect of any claim, loss,
damage or expense (including, without limitation, reasonable attorneys’ fees) arising or resulting therefrom to the fullest extent permitted by law and/or
under the Company’s articles or bylaws or any directors’ and officers’ liability insurance coverage which may be in effect from time to time and/or any
indemnification agreement between such individual and the Company.
(e)
Foreign Award Recipients. Notwithstanding any provision of the Plan to the contrary, in order to comply with the laws in other
countries in which the Company and its Subsidiaries operate or have employees or other individuals eligible for Awards, the Administrator, in its sole
discretion, shall have the power and authority to: (i) determine which Subsidiaries shall be covered by the Plan; (ii) determine which Eligible Individuals
outside the United States are eligible to participate in the Plan; (iii) modify the terms and conditions of any Award granted to individuals outside the United
States to comply with applicable foreign laws; (iv) establish subplans and modify exercise procedures and other terms and procedures, to the extent the
Administrator determines such actions to be necessary or advisable (and such subplans and/or modifications shall be attached to this Plan as appendices);
provided, however, that no such subplans and/or modifications shall increase the share limitations contained in Section 3(a) hereof; and (v) take any action,
before or after an Award is made, that the Administrator determines to
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be necessary or advisable to obtain approval or comply with any local governmental regulatory exemptions or approvals. Notwithstanding the foregoing,
the Administrator may not take any actions hereunder, and no Awards shall be granted, that would violate the Exchange Act or any other applicable United
States securities law, the Code, or any other applicable United States governing statute or law.
SECTION 3.
STOCK ISSUABLE UNDER THE PLAN; MERGERS; SUBSTITUTION
(a)
Stock Issuable. The maximum number of shares of Stock reserved and available for issuance under the Plan shall be 500,000 (the
“Share Limit”), subject to adjustment as provided in Section 3(b). For purposes of this limitation, the shares of Stock underlying any Awards that are
forfeited, canceled, held back upon exercise of an Option or settlement of an Award to cover the exercise price or tax withholding, reacquired by the
Company prior to vesting, satisfied without the issuance of Stock or otherwise terminated (other than by exercise) under each of the Plan shall be added
back to the shares of Stock available for issuance under the Plan. Subject to such overall limitations, shares of Stock may be issued up to such maximum
number pursuant to any type or types of Award. The shares available for issuance under the Plan may be authorized but unissued shares of Stock or shares
of Stock reacquired by the Company.
(b)
Changes in Stock. Subject to Section 3(c) hereof, if, as a result of any reorganization, recapitalization, reclassification, stock dividend,
stock split, reverse stock split or other similar change in the Company’s capital stock, the outstanding shares of Stock are increased or decreased or are
exchanged for a different number or kind of shares or other securities of the Company, or additional shares or new or different shares or other securities of
the Company or other non-cash assets are distributed with respect to such shares of Stock or other securities, or, if, as a result of any merger or
consolidation, sale of all or substantially all of the assets of the Company, the outstanding shares of Stock are converted into or exchanged for securities of
the Company or any successor entity (or a parent or subsidiary thereof), the Administrator shall make an appropriate or proportionate adjustment in (i) the
maximum number of shares reserved for issuance under the Plan, including the maximum number of shares that may be issued in the form of Incentive
Stock Options, (ii) the number of Stock Options or Stock Appreciation Rights that can be granted to any one individual grantee and the maximum number
of shares that may be granted under a Performance-Based Award, (iii) the number and kind of shares or other securities subject to any then outstanding
Awards under the Plan, (iv) the repurchase price, if any, per share subject to each outstanding Restricted Stock Award, and (v) the exercise price for each
share subject to any then outstanding Stock Options and Stock Appreciation Rights under the Plan, without changing the aggregate exercise price (i.e., the
exercise price multiplied by the number of Stock Options and Stock Appreciation Rights) as to which such Stock Options and Stock Appreciation Rights
remain exercisable. The Administrator shall also make equitable or proportionate adjustments in the number of shares subject to outstanding Awards and
the exercise price and the terms of outstanding Awards to take into consideration cash dividends paid other than in the ordinary course or any other
extraordinary corporate event. The adjustment by the Administrator shall be final, binding and conclusive. No fractional shares of Stock shall be issued
under the Plan resulting from any such adjustment, but the Administrator in its discretion may make a cash payment in lieu of fractional shares.
(c)
Mergers and Other Transactions. In the case of and subject to the consummation of a Sale Event, the parties thereto may cause the
assumption or continuation of Awards theretofore granted by the successor entity, or the substitution of such Awards with new Awards of the successor
entity or parent thereof, with appropriate adjustment as to the number and kind of shares and, if appropriate, the per share exercise prices, as such parties
shall agree. To the extent the parties to such Sale Event do not provide for the assumption, continuation or substitution of Awards, upon the effective time
of the Sale Event, the Plan and all outstanding Awards granted hereunder shall terminate. In such case, except as may be otherwise provided in the relevant
Award Certificate, all Options and Stock Appreciation Rights that are not exercisable immediately prior to the effective time of the Sale Event shall become
fully vested and nonforfeitable as of the effective time of the Sale Event, and all Awards with conditions and restrictions relating to the attainment of
performance goals may become vested and nonforfeitable in connection with a Sale Event in the Administrator’s discretion or to the extent specified in the
relevant Award Certificate. In the event of such termination, (i) the Company shall have the option (in its sole discretion) to make or provide for a
payment, in cash or in kind, to the grantees holding Options and Stock Appreciation Rights, in exchange for the cancellation thereof, in an amount equal to
the difference between (A) the Sale Price multiplied by the number of shares of Stock subject to outstanding Options and Stock Appreciation Rights (to the
extent then exercisable at prices not in excess of the Sale Price) and (B) the aggregate exercise price of all such outstanding Options and Stock
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Appreciation Rights; or (ii) each grantee shall be permitted, within a specified period of time prior to the consummation of the Sale Event as determined by
the Administrator, to exercise all outstanding Options and Stock Appreciation Rights (to the extent then exercisable) held by such grantee. The Company
shall also have the option (in its sole discretion) to make or provide for a payment, in cash or in kind, to the grantees holding other Awards in an amount
equal to the Sale Price multiplied by the number of vested shares of Stock under such Awards.
SECTION 4.
ELIGIBILITY
Grantees under the Plan will be limited to solely Eligible Individuals as are selected from time to time by the Administrator in its sole discretion.
SECTION 5.
STOCK OPTIONS
(a)
Award of Stock Options. The Administrator may grant Stock Options under the Plan. Any Stock Option granted under the Plan shall
be in such form as the Administrator may from time to time approve.
Stock Options granted under the Plan shall only be Non-Qualified Stock Options. No Incentive Stock Options may be granted under the Plan.
Stock Options granted pursuant to this Section 5 shall be subject to the following terms and conditions and shall contain such additional terms
and conditions, not inconsistent with the terms of the Plan, as the Administrator shall deem desirable. If the Administrator so determines, Stock Options
may be granted in lieu of cash compensation at the optionee’s election, subject to such terms and conditions as the Administrator may establish.
(b)
Exercise Price. The exercise price per share for the Stock covered by a Stock Option granted pursuant to this Section 5 shall be
determined by the Administrator at the time of grant but shall not be less than 100 percent of the Fair Market Value on the date of grant.
(c)
Option Term. The term of each Stock Option shall be fixed by the Administrator, but no Stock Option shall be exercisable more than
ten years after the date the Stock Option is granted.
(d)
Exercisability; Rights of a Stockholder. Stock Options shall become exercisable at such time or times, whether or not in installments,
as shall be determined by the Administrator at or after the grant date. The Administrator may at any time accelerate the exercisability of all or any portion
of any Stock Option. An optionee shall have the rights of a stockholder only as to shares acquired upon the exercise of a Stock Option and not as to
unexercised Stock Options.
(e)
Method of Exercise. Stock Options may be exercised in whole or in part, by giving written or electronic notice of exercise to the
Company, specifying the number of shares to be purchased. Payment of the purchase price may be made by one or more of the following methods except
to the extent otherwise provided in the Option Award Certificate:
(i)
(ii)
In cash, by certified or bank check or other instrument acceptable to the Administrator;
Through the delivery (or attestation to the ownership following such procedures as the Company may prescribe)
of shares of Stock that are not then subject to restrictions under any Company plan. Such surrendered shares shall be valued at Fair Market Value on the
exercise date;
(iii)
By the optionee delivering to the Company a properly executed exercise notice together with irrevocable
instructions to a broker to promptly deliver to the Company cash or a check payable and acceptable to the Company for the purchase price; provided that in
the event the optionee chooses to pay the purchase price as so provided, the optionee and the broker shall comply with such procedures and enter into such
agreements of indemnity and other agreements as the Company shall prescribe as a condition of such payment procedure; or
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issuable upon exercise by the largest whole number of shares with a Fair Market Value that does not exceed the aggregate exercise price.
(iv)
By a “net exercise” arrangement pursuant to which the Company will reduce the number of shares of Stock
Payment instruments will be received subject to collection. The transfer to the optionee on the records of the Company or of the transfer agent of the shares
of Stock to be purchased pursuant to the exercise of a Stock Option will be contingent upon receipt from the optionee (or a purchaser acting in his stead in
accordance with the provisions of the Stock Option) by the Company of the full purchase price for such shares and the fulfillment of any other
requirements contained in the Option Award Certificate or applicable provisions of laws (including the satisfaction of any withholding taxes that the
Company is obligated to withhold with respect to the optionee). In the event an optionee chooses to pay the purchase price by previously-owned shares of
Stock through the attestation method, the number of shares of Stock transferred to the optionee upon the exercise of the Stock Option shall be net of the
number of attested shares. In the event that the Company establishes, for itself or using the services of a third party, an automated system for the exercise
of Stock Options, such as a system using an internet website or interactive voice response, then the paperless exercise of Stock Options may be permitted
through the use of such an automated system.
SECTION 6.
STOCK APPRECIATION RIGHTS
(a)
Award of Stock Appreciation Rights. The Administrator may grant Stock Appreciation Rights under the Plan. A Stock Appreciation
Right is an Award entitling the recipient to receive shares of Stock having a value equal to the excess of the Fair Market Value of a share of Stock on the
date of exercise over the exercise price of the Stock Appreciation Right multiplied by the number of shares of Stock with respect to which the Stock
Appreciation Right shall have been exercised.
(b)
Exercise Price of Stock Appreciation Rights. The exercise price of a Stock Appreciation Right shall not be less than 100 percent of the
Fair Market Value of the Stock on the date of grant.
(c)
Grant and Exercise of Stock Appreciation Rights. Stock Appreciation Rights may be granted by the Administrator independently of
any Stock Option granted pursuant to Section 5 of the Plan.
(d)
Terms and Conditions of Stock Appreciation Rights. Stock Appreciation Rights shall be subject to such terms and conditions as shall
be determined on the date of grant by the Administrator. The term of a Stock Appreciation Right may not exceed ten years. The terms and conditions of
each such Award shall be determined by the Administrator, and such terms and conditions may differ among individual Awards and grantees.
SECTION 7.
RESTRICTED STOCK AWARDS
(a)
Nature of Restricted Stock Awards. The Administrator may grant Restricted Stock Awards under the Plan. A Restricted Stock Award
is any Award of Restricted Shares subject to such restrictions and conditions as the Administrator may determine at the time of grant. Conditions may be
based on continuing employment (or other service relationship) and/or achievement of pre-established performance goals and objectives.
(b)
Rights as a Stockholder. Upon the grant of the Restricted Stock Award and payment of any applicable purchase price, a grantee shall
have the rights of a stockholder with respect to the voting of the Restricted Shares and receipt of dividends; provided that if the lapse of restrictions with
respect to the Restricted Stock Award is tied to the attainment of performance goals, any dividends paid by the Company during the performance period
shall accrue and shall not be paid to the grantee until and to the extent the performance goals are met with respect to the Restricted Stock Award. Unless
the Administrator shall otherwise determine, (i) uncertificated Restricted Shares shall be accompanied by a notation on the records of the Company or the
transfer agent to the effect that they are subject to forfeiture until such Restricted Shares are vested as provided in Section 7(d) below, and (ii) certificated
Restricted Shares shall remain in the possession of the Company until such Restricted Shares are vested as provided in Section 7(d) below, and the grantee
shall be required, as a condition of the grant, to deliver to the Company such instruments of transfer as the Administrator may prescribe.
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(c)
Restrictions. Restricted Shares may not be sold, assigned, transferred, pledged or otherwise encumbered or disposed of except as
specifically provided herein or in the Restricted Stock Award Certificate. Except as may otherwise be provided by the Administrator either in the Award
Certificate or, subject to Section 18 below, in writing after the Award is issued, if a grantee’s employment (or other service relationship) with the Company
and its Subsidiaries terminates for any reason, any Restricted Shares that have not vested at the time of termination shall automatically and without any
requirement of notice to such grantee from or other action by or on behalf of, the Company be deemed to have been reacquired by the Company at its
original purchase price (if any) from such grantee or such grantee’s legal representative simultaneously with such termination of employment (or other
service relationship), and thereafter shall cease to represent any ownership of the Company by the grantee or rights of the grantee as a stockholder.
Following such deemed reacquisition of Restricted Shares that are represented by physical certificates, a grantee shall surrender such certificates to the
Company upon request without consideration.
(d)
Vesting of Restricted Shares. The Administrator at the time of grant shall specify the date or dates and/or the attainment of pre-
established performance goals, objectives and other conditions on which the non-transferability of the Restricted Shares and the Company’s right of
repurchase or forfeiture shall lapse. Subsequent to such date or dates and/or the attainment of such pre-established performance goals, objectives and other
conditions, the shares on which all restrictions have lapsed shall no longer be Restricted Shares and shall be deemed “vested.”
SECTION 8.
RESTRICTED STOCK UNITS
(a)
Nature of Restricted Stock Units. The Administrator may grant Restricted Stock Units under the Plan. A Restricted Stock Unit is an
Award of stock units that may be settled in shares of Stock upon the satisfaction of such restrictions and conditions at the time of grant. Conditions may be
based on continuing employment (or other service relationship) and/or achievement of pre-established performance goals and objectives. The terms and
conditions of each such Award shall be determined by the Administrator, and such terms and conditions may differ among individual Awards and grantees.
Except in the case of Restricted Stock Units with a deferred settlement date that complies with Section 409A, at the end of the vesting period, the
Restricted Stock Units, to the extent vested, shall be settled in the form of shares of Stock. Restricted Stock Units with deferred settlement dates are subject
to Section 409A and shall contain such additional terms and conditions as the Administrator shall determine in its sole discretion in order to comply with
the requirements of Section 409A.
(b)
Rights as a Stockholder. A grantee shall have the rights as a stockholder only as to shares of Stock acquired by the grantee upon
settlement of Restricted Stock Units; provided, however, that the grantee may be credited with Dividend Equivalent Rights with respect to the stock units
underlying his Restricted Stock Units, subject to the provisions of Section 13 and such terms and conditions as the Administrator may determine.
(c)
Termination. Except as may otherwise be provided by the Administrator either in the Award Certificate or, subject to Section 18
below, in writing after the Award is issued, a grantee’s right in all Restricted Stock Units that have not vested shall automatically terminate upon the
grantee’s termination of employment (or cessation of service relationship) with the Company and its Subsidiaries for any reason.
SECTION 9.
UNRESTRICTED STOCK AWARDS
Grant or Sale of Unrestricted Stock. The Administrator may grant (or sell at par value or such higher purchase price determined by the
Administrator) an Unrestricted Stock Award under the Plan. An Unrestricted Stock Award is an Award pursuant to which the grantee may receive shares of
Stock free of any restrictions under the Plan. Unrestricted Stock Awards may be granted in respect of past services or other valid consideration, or in lieu
of cash compensation due to such grantee.
SECTION 10.
CASH-BASED AWARDS
Grant of Cash-Based Awards. The Administrator may grant Cash-Based Awards under the Plan. A Cash-Based Award is an Award that entitles
the grantee to a payment in cash upon the attainment of specified
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Performance Goals. The Administrator shall determine the maximum duration of the Cash-Based Award, the amount of cash to which the Cash-Based
Award pertains, the conditions upon which the Cash-Based Award shall become vested or payable, and such other provisions as the Administrator shall
determine. Each Cash-Based Award shall specify a cash-denominated payment amount, formula or payment ranges as determined by the Administrator.
Payment, if any, with respect to a Cash-Based Award shall be made in accordance with the terms of the Award and may be made in cash.
SECTION 11.
PERFORMANCE SHARE AWARDS
(a)
Nature of Performance Share Awards. The Administrator may grant Performance Share Awards under the Plan. A Performance Share
Award is an Award entitling the grantee to receive shares of Stock upon the attainment of performance goals. The Administrator shall determine whether
and to whom Performance Share Awards shall be granted, the Performance Goals, the periods during which performance is to be measured, which may not
be less than one year except in the case of a Sale Event, and such other limitations and conditions as the Administrator shall determine.
(b)
Rights as a Stockholder. A grantee receiving a Performance Share Award shall have the rights of a stockholder only as to shares of
Stock actually received by the grantee under the Plan and not with respect to shares subject to the Award but not actually received by the grantee. A
grantee shall be entitled to receive shares of Stock under a Performance Share Award only upon satisfaction of all conditions specified in the Performance
Share Award Certificate (or in a performance plan adopted by the Administrator).
(c)
Termination. Except as may otherwise be provided by the Administrator either in the Award agreement or, subject to Section 18
below, in writing after the Award is issued, a grantee’s rights in all Performance Share Awards shall automatically terminate upon the grantee’s termination
of employment (or cessation of service relationship) with the Company and its Subsidiaries for any reason.
SECTION 12.
PERFORMANCE-BASED AWARDS
(a)
Performance-Based Awards. The Administrator may grant one or more Performance-Based Awards in the form of a Restricted Stock
Award, Restricted Stock Units, Performance Share Awards or Cash-Based Award payable upon the attainment of Performance Goals that are established by
the Administrator and relate to one or more of the Performance Criteria, in each case on a specified date or dates or over any period or periods determined
by the Administrator. The Administrator shall define the manner of calculating the Performance Criteria it selects to use for any Performance Cycle.
Depending on the Performance Criteria used to establish such Performance Goals, the Performance Goals may be expressed in terms of overall Company
performance or the performance of a division, business unit, or an individual. Each Performance-Based Award shall comply with the provisions set forth
below.
(b)
Grant of Performance-Based Awards. With respect to each Performance-Based Award, the Administrator shall select the Performance
Criteria for such grant, and the Performance Goals with respect to each Performance Criterion. Each Performance-Based Award will specify the amount
payable, or the formula for determining the amount payable, upon achievement of the various applicable performance targets. The Performance Criteria
established by the Administrator may be (but need not be) different for each Performance Cycle and different Performance Goals may be applicable to
Performance-Based Awards to different grantees.
(c)
Payment of Performance-Based Awards. Following the completion of a Performance Cycle, the Administrator shall meet to review
and certify in writing whether, and to what extent, the Performance Goals for the Performance Cycle have been achieved and, if so, to also calculate and
certify in writing the amount of the Performance-Based Awards earned for the Performance Cycle. The Administrator shall then determine the actual size
of each grantee’s Performance-Based Award.
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SECTION 13.
DIVIDEND EQUIVALENT RIGHTS
(a)
Dividend Equivalent Rights. The Administrator may grant Dividend Equivalent Rights under the Plan. A Dividend Equivalent Right
is an Award entitling the grantee to receive credits based on cash dividends that would have been paid on the shares of Stock specified in the Dividend
Equivalent Right (or other Award to which it relates) if such shares had been issued to the grantee. A Dividend Equivalent Right may be granted hereunder
to any grantee as a component of an award of Restricted Stock Units or Performance Share Award or as a freestanding award. The terms and conditions of
Dividend Equivalent Rights shall be specified in the Award Certificate. Dividend equivalents credited to the holder of a Dividend Equivalent Right may be
paid currently or may be deemed to be reinvested in additional shares of Stock, which may thereafter accrue additional equivalents. Any such reinvestment
shall be at Fair Market Value on the date of reinvestment or such other price as may then apply under a dividend reinvestment plan sponsored by the
Company, if any. Dividend Equivalent Rights may be settled in cash or shares of Stock or a combination thereof, in a single installment or installments. A
Dividend Equivalent Right granted as a component of an Award of Restricted Stock Units or Performance Share Award shall provide that such Dividend
Equivalent Right shall be settled only upon settlement or payment of, or lapse of restrictions on, such other Award, and that such Dividend Equivalent
Right shall expire or be forfeited or annulled under the same conditions as such other Award.
(b)
Termination. Except as may otherwise be provided by the Administrator either in the Award Certificate or, subject to Section 18
below, in writing after the Award is issued, a grantee’s rights in all Dividend Equivalent Rights shall automatically terminate upon the grantee’s termination
of employment (or cessation of service relationship) with the Company and its Subsidiaries for any reason.
SECTION 14.
TRANSFERABILITY OF AWARDS
(a)
Transferability. Except as provided in Section 14(b) below, during a grantee’s lifetime, his or her Awards shall be exercisable only by
the grantee, or by the grantee’s legal representative or guardian in the event of the grantee’s incapacity. No Awards shall be sold, assigned, transferred or
otherwise encumbered or disposed of by a grantee other than by will or by the laws of descent and distribution or pursuant to a domestic relations order.
No Awards shall be subject, in whole or in part, to attachment, execution, or levy of any kind, and any purported transfer in violation hereof shall be null
and void.
(b)
Administrator Action. Notwithstanding Section 14(a), the Administrator, in its discretion, may provide either in the Award Certificate
regarding a given Award or by subsequent written approval that the grantee may transfer his or her Non-Qualified Stock Options to his or her immediate
family members, to trusts for the benefit of such family members, or to partnerships in which such family members are the only partners, provided that the
transferee agrees in writing with the Company to be bound by all of the terms and conditions of this Plan and the applicable Award. In no event may an
Award be transferred by a grantee for value.
(c)
Family Member. For purposes of Section 14(b), “family member” shall mean a grantee’s child, stepchild, grandchild, parent,
stepparent, grandparent, spouse, former spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-
in-law, including adoptive relationships, any person sharing the grantee’s household (other than a tenant of the grantee), a trust in which these persons (or
the grantee) have more than 50 percent of the beneficial interest, a foundation in which these persons (or the grantee) control the management of assets, and
any other entity in which these persons (or the grantee) own more than 50 percent of the voting interests.
(d)
Designation of Beneficiary. To the extent permitted by the Company, each grantee to whom an Award has been made under the Plan
may designate a beneficiary or beneficiaries to exercise any Award or receive any payment under any Award payable on or after the grantee’s death. Any
such designation shall be on a form provided for that purpose by the Administrator and shall not be effective until received by the Administrator. If no
beneficiary has been designated by a deceased grantee, or if the designated beneficiaries have predeceased the grantee, the beneficiary shall be the grantee’s
estate.
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SECTION 15.
TAX WITHHOLDING
(a)
Payment by Grantee. Each grantee shall, no later than the date as of which the value of an Award or of any Stock or other amounts
received thereunder first becomes includable in the gross income of the grantee for Federal income tax purposes, pay to the Company, or make
arrangements satisfactory to the Administrator regarding payment of, any Federal, state, or local taxes of any kind required by law to be withheld by the
Company with respect to such income. The Company and its Subsidiaries shall, to the extent permitted by law, have the right to deduct any such taxes
from any payment of any kind otherwise due to the grantee. The Company’s obligation to deliver evidence of book entry (or stock certificates) to any
grantee is subject to and conditioned on tax withholding obligations being satisfied by the grantee.
(b)
Payment in Stock. Subject to approval by the Administrator, a grantee may elect to have the Company’s minimum required tax
withholding obligation satisfied, in whole or in part, by authorizing the Company to withhold from shares of Stock to be issued pursuant to any Award a
number of shares with an aggregate Fair Market Value (as of the date the withholding is effected) that would satisfy the withholding amount due. The
Administrator may also require Awards to be subject to mandatory share withholding up to the required withholding amount. For purposes of share
withholding, the Fair Market Value of withheld shares shall be determined in the same manner as the value of Stock includible in income of the
Participants.
SECTION 16.
SECTION 409A AWARDS
To the extent that any Award is determined to constitute “nonqualified deferred compensation” within the meaning of Section 409A (a “409A
Award”), the Award shall be subject to such additional rules and requirements as specified by the Administrator from time to time in order to comply with
Section 409A. In this regard, if any amount under a 409A Award is payable upon a “separation from service” (within the meaning of Section 409A) to a
grantee who is then considered a “specified employee” (within the meaning of Section 409A), then no such payment shall be made prior to the date that is
the earlier of (i) six months and one day after the grantee’s separation from service, or (ii) the grantee’s death, but only to the extent such delay is necessary
to prevent such payment from being subject to interest, penalties and/or additional tax imposed pursuant to Section 409A. Further, the settlement of any
such Award may not be accelerated except to the extent permitted by Section 409A.
SECTION 17.
TERMINATION OF EMPLOYMENT, TRANSFER, LEAVE OF ABSENCE, ETC.
(a)
Termination of Employment. If the grantee’s employer ceases to be a Subsidiary, the grantee shall be deemed to have terminated
employment for purposes of the Plan.
(b)
For purposes of the Plan, the following events shall not be deemed a termination of employment:
one Subsidiary to another; or
(i)
a transfer to the employment of the Company from a Subsidiary or from the Company to a Subsidiary, or from
(ii)
an approved leave of absence for military service or sickness, or for any other purpose approved by the Company,
if the Employee’s right to re-employment is guaranteed either by a statute or by contract or under the policy pursuant to which the leave of absence was
granted or if the Administrator otherwise so provides in writing.
SECTION 18.
AMENDMENTS AND TERMINATION
The Board may, at any time, amend or discontinue the Plan and the Administrator may, at any time, amend or cancel any outstanding Award for
the purpose of satisfying changes in law or for any other lawful purpose, but no such action shall adversely affect rights under any outstanding Award
without the holder’s consent. Except as provided in Section 3(c) or 3(d), without prior stockholder approval, in no event may the Administrator exercise its
discretion to reduce the exercise price of outstanding Stock Options or Stock Appreciation Rights or effect repricing through cancellation and re-grants or
cancellation of Stock Options or Stock Appreciation Rights in exchange for
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cash or other Awards. Nothing in this Section 18 shall limit the Administrator’s authority to take any action permitted pursuant to Section 3(c) or 3(d).
SECTION 19.
STATUS OF PLAN
With respect to the portion of any Award that has not been exercised and any payments in cash, Stock or other consideration not received by a
grantee, a grantee shall have no rights greater than those of a general creditor of the Company unless the Administrator shall otherwise expressly determine
in connection with any Award or Awards. In its sole discretion, the Administrator may authorize the creation of trusts or other arrangements to meet the
Company’s obligations to deliver Stock or make payments with respect to Awards hereunder, provided that the existence of such trusts or other
arrangements is consistent with the foregoing sentence.
SECTION 20.
GENERAL PROVISIONS
(a)
Stockholder Approval Not Required. It is expressly intended that approval of the Company’s stockholders not be required as a
condition of the effectiveness of the Plan, and the Plan’s provisions shall be interpreted in a manner consistent with such intent for all purposes.
Specifically, NASDAQ Rule 5635(c) generally requires stockholder approval for equity compensation plans adopted by companies whose securities are
listed on the NASDAQ Stock Market that provide for the delivery of equity securities to any employees, directors or other service providers of such
companies as compensation for services. NASDAQ Rule 5635(c)(4) provides an exemption in certain circumstances for employment inducement awards.
Notwithstanding anything to the contrary herein, in accordance with NASDAQ Rule 5635(c)(4), Awards may only be granted as material inducements to
Eligible Individuals being hired or rehired as Employees, as applicable, and must be approved by (a) the Board, acting through a majority of the Company’s
Independent Directors or (b) the independent Compensation Committee of the Board. Accordingly, pursuant to NASDAQ Rule 5635(c)(4), the issuance of
Awards and the Shares issuable upon exercise or vesting of such Awards pursuant to the Plan is not subject to the approval of the Company’s stockholders
(b)
Action Required Upon Grant of Award. Promptly following the grant of an Award, the Company shall, in accordance with NASDAQ
Rule 5635(c), (a) issue a press release disclosing the material terms of the Award, including the recipient(s) of the Award and the number of Shares
involved and(b) provide written notice to the NASDAQ of the grant.
(c)
No Distribution. The Administrator may require each person acquiring Stock pursuant to an Award to represent to and agree with the
Company in writing that such person is acquiring the shares without a view to distribution thereof.
(d)
Delivery of Stock Certificates. Stock certificates to grantees under this Plan shall be deemed delivered for all purposes when the
Company or a stock transfer agent of the Company shall have mailed such certificates in the United States mail, addressed to the grantee, at the grantee’s
last known address on file with the Company. Uncertificated Stock shall be deemed delivered for all purposes when the Company or a Stock transfer agent
of the Company shall have given to the grantee by electronic mail (with proof of receipt) or by United States mail, addressed to the grantee, at the grantee’s
last known address on file with the Company, notice of issuance and recorded the issuance in its records (which may include electronic “book entry”
records). Notwithstanding anything herein to the contrary, the Company shall not be required to issue or deliver any certificates evidencing shares of Stock
pursuant to the exercise of any Award, unless and until the Administrator has determined, with advice of counsel (to the extent the Administrator deems
such advice necessary or advisable), that the issuance and delivery of such certificates is in compliance with all applicable laws, regulations of
governmental authorities and, if applicable, the requirements of any exchange on which the shares of Stock are listed, quoted or traded. All Stock
certificates delivered pursuant to the Plan shall be subject to any stop-transfer orders and other restrictions as the Administrator deems necessary or
advisable to comply with federal, state or foreign jurisdiction, securities or other laws, rules and quotation system on which the Stock is listed, quoted or
traded. The Administrator may place legends on any Stock certificate to reference restrictions applicable to the Stock. In addition to the terms and
conditions provided herein, the Administrator may require that an individual make such reasonable covenants, agreements, and representations as the
Administrator, in its discretion, deems necessary or advisable in order to comply with any such laws, regulations, or requirements. The Administrator shall
have the right to require any individual to comply with any
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12
timing or other restrictions with respect to the settlement or exercise of any Award, including a window-period limitation, as may be imposed in the
discretion of the Administrator.
(e)
Stockholder Rights. Until Stock is deemed delivered in accordance with Section 20(b), no right to vote or receive dividends or any
other rights of a stockholder will exist with respect to shares of Stock to be issued in connection with an Award, notwithstanding the exercise of a Stock
Option or any other action by the grantee with respect to an Award.
(f)
Other Compensation Arrangements; No Employment Rights. Nothing contained in this Plan shall prevent the Board from adopting
other or additional compensation arrangements, including trusts, and such arrangements may be either generally applicable or applicable only in specific
cases. The adoption of this Plan and the grant of Awards do not confer upon any Employee any right to continued employment with the Company or any
Subsidiary.
(g)
Trading Policy Restrictions. Option exercises and other Awards under the Plan shall be subject to the Company’s insider trading
policies and procedures, as in effect from time to time.
(h)
Clawback Policy. Awards under the Plan shall be subject to the Company’s clawback policy, as in effect from time to time.
SECTION 21.
EFFECTIVE DATE OF PLAN
Unless earlier terminated by the Board, the Plan will become effective on the date it is approved by the Board and will remain in effect until the
tenth anniversary of such date, but Awards previously granted may extend beyond that date in accordance with the Plan. No Awards may be granted under
the Plan during any suspension period or after Plan termination.
SECTION 22.
GOVERNING LAW
This Plan and all Awards and actions taken thereunder shall be governed by, and construed in accordance with, the laws of the State of Delaware,
applied without regard to conflict of law principles.
DATE APPROVED BY BOARD OF DIRECTORS: February 1, 2023
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13
NON-QUALIFIED STOCK OPTION AGREEMENT
UNDER THE SCPHARMACEUTICALS INC.
2023 EMPLOYMENT INDUCEMENT PLAN
Exhibit 10.5
Name of Optionee:
No. of Option Shares:
Option Exercise Price per Share: $
Grant Date:
Expiration Date:
Pursuant to the scPharmaceuticals Inc. 2023 Employment Inducement Award as amended through the date hereof (the “Plan”),
scPharmaceuticals Inc. (the “Company”) hereby grants to the Optionee named above an option (the “Stock Option”) to purchase on or prior to the
Expiration Date specified above all or part of the number of shares of Common Stock, par value $0.0001 per share (the “Stock”) of the Company specified
above at the Option Exercise Price per Share specified above subject to the terms and conditions set forth herein and in the Plan. This Stock Option is not
intended to be an “incentive stock option” under Section 422 of the Internal Revenue Code of 1986, as amended. This Stock Option is intended to
constitute an “employment inducement award” under NASDAQ Rule 5635(c)(4) that is exempt from the requirements of shareholder approval of equity
compensation plans under NASDAQ Rule 5635(c)(4). This Agreement and the terms and conditions of the Stock Option will be interpreted consistent with
such intent.
1.
Exercisability Schedule. No portion of this Stock Option may be exercised until such portion shall have become exercisable. Except
as set forth below, and subject to the discretion of the Administrator (as defined in Section 2 of the Plan) to accelerate the exercisability schedule hereunder,
this Stock Option shall be exercisable with respect to the following number of Option Shares on the dates indicated so long as Optionee remains an
employee of the Company or a Subsidiary on such dates:
See attached vesting schedule.
Once exercisable, this Stock Option shall continue to be exercisable at any time or times prior to the close of business on the Expiration Date,
subject to the provisions hereof and of the Plan.
2.
Manner of Exercise.
(a)
The Optionee may exercise this Stock Option only in the following manner: from time to time on or prior to the
Expiration Date of this Stock Option, the Optionee may give written notice to the Administrator of his or her election to purchase some or all of the Option
Shares purchasable at the time of such notice. This notice shall specify the number of Option Shares to be purchased.
Payment of the purchase price for the Option Shares may be made by one or more of the following methods: (i) in cash, by certified or bank
check or other instrument acceptable to the Administrator; (ii) through the delivery (or attestation to the ownership) of shares of Stock that have been
purchased by the Optionee on the open market or that are beneficially owned by the Optionee and are not then subject to any restrictions under any
Company plan and that otherwise satisfy any holding periods as may be required by the Administrator; (iii) by the Optionee delivering to the Company a
properly executed exercise notice together with irrevocable instructions to a broker to promptly deliver to the Company cash or a check payable and
acceptable to the Company to pay the option purchase price, provided that in the event the Optionee chooses to pay the option purchase price as so
provided, the Optionee and the broker shall comply with such procedures and enter into such agreements of indemnity and other agreements as the
Administrator shall prescribe as a condition of such payment procedure; (iv) by a “net exercise” arrangement pursuant to which the Company will reduce
the number of shares of Stock issuable upon exercise by
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the largest whole number of shares with a Fair Market Value that does not exceed the aggregate exercise price; or (v) a combination of (i), (ii), (iii) and (iv)
above. Payment instruments will be received subject to collection.
The transfer to the Optionee on the records of the Company or of the transfer agent of the Option Shares will be contingent upon (i) the
Company’s receipt from the Optionee of the full purchase price for the Option Shares, as set forth above, (ii) the fulfillment of any other requirements
contained herein or in the Plan or in any other agreement or provision of laws, and (iii) the receipt by the Company of any agreement, statement or other
evidence that the Company may require to satisfy itself that the issuance of Stock to be purchased pursuant to the exercise of Stock Options under the Plan
and any subsequent resale of the shares of Stock will be in compliance with applicable laws and regulations. In the event the Optionee chooses to pay the
purchase price by previously-owned shares of Stock through the attestation method, the number of shares of Stock transferred to the Optionee upon the
exercise of the Stock Option shall be net of the Shares attested to.
(b)
The shares of Stock purchased upon exercise of this Stock Option shall be transferred to the Optionee on the
records of the Company or of the transfer agent upon compliance to the satisfaction of the Administrator with all requirements under applicable laws or
regulations in connection with such transfer and with the requirements hereof and of the Plan. The determination of the Administrator as to such
compliance shall be final and binding on the Optionee. The Optionee shall not be deemed to be the holder of, or to have any of the rights of a holder with
respect to, any shares of Stock subject to this Stock Option unless and until this Stock Option shall have been exercised pursuant to the terms hereof, the
Company or the transfer agent shall have transferred the shares to the Optionee, and the Optionee’s name shall have been entered as the stockholder of
record on the books of the Company. Thereupon, the Optionee shall have full voting, dividend and other ownership rights with respect to such shares of
Stock.
(c)
The minimum number of shares with respect to which this Stock Option may be exercised at any one time shall
be 100 shares, unless the number of shares with respect to which this Stock Option is being exercised is the total number of shares subject to exercise under
this Stock Option at the time.
after the Expiration Date hereof.
(d)
Notwithstanding any other provision hereof or of the Plan, no portion of this Stock Option shall be exercisable
3.
Termination of Employment. If the Optionee’s employment by the Company or a Subsidiary (as defined in the Plan) is terminated, the
period within which to exercise the Stock Option (to the extent exercisable) may be subject to earlier termination as set forth below.
(a)
Termination Due to Death. If the Optionee’s employment terminates by reason of the Optionee’s death, any
portion of this Stock Option outstanding on such date, to the extent exercisable on the date of death, may thereafter be exercised by the Optionee’s legal
representative or legatee for a period of 12 months from the date of death or until the Expiration Date, if earlier. Any portion of this Stock Option that is
not exercisable on the date of death shall terminate immediately and be of no further force or effect.
(b)
Termination Due to Disability. If the Optionee’s employment terminates by reason of the Optionee’s disability (as
determined by the Administrator), any portion of this Stock Option outstanding on such date, to the extent exercisable on the date of such termination of
employment, may thereafter be exercised by the Optionee for a period of 12 months from the date of disability or until the Expiration Date, if earlier. Any
portion of this Stock Option that is not exercisable on the date of disability shall terminate immediately and be of no further force or effect.
(c)
Termination for Cause. If the Optionee’s employment terminates for Cause, any portion of this Stock Option
outstanding on such date shall terminate immediately and be of no further force and effect. For purposes hereof, “Cause” shall mean, unless otherwise
provided in an employment agreement between the Company and the Optionee, a determination by the Administrator that the Optionee shall be dismissed
as a result of (i) any material breach by the Optionee of any agreement between the Optionee and the Company; (ii) the conviction of, indictment for or
plea of nolo contendere by the Optionee to a felony or a crime involving moral turpitude; or (iii) any material misconduct or willful and deliberate non-
performance (other than by reason of disability) by the Optionee of the Optionee’s duties to the Company.
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(d)
Other Termination. If the Optionee’s employment terminates for any reason other than the Optionee’s death, the
Optionee’s disability or Cause, and unless otherwise determined by the Administrator, any portion of this Stock Option outstanding on such date may be
exercised, to the extent exercisable on the date of termination, for a period of three months from the date of termination or until the Expiration Date, if
earlier. Any portion of this Stock Option that is not exercisable on the date of termination shall terminate immediately and be of no further force or effect.
The Administrator’s determination of the reason for termination of the Optionee’s employment shall be conclusive and binding on the Optionee
and his or her representatives or legatees.
4.
Incorporation of Plan. Notwithstanding anything herein to the contrary, this Stock Option shall be subject to and governed by all the
terms and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms in this Agreement shall
have the meaning specified in the Plan, unless a different meaning is specified herein.
5.
Transferability. This Agreement is personal to the Optionee, is non-assignable and is not transferable in any manner, by operation of
law or otherwise, other than by will or the laws of descent and distribution. This Stock Option is exercisable, during the Optionee’s lifetime, only by the
Optionee, and thereafter, only by the Optionee’s legal representative or legatee.
6.
Tax Withholding. The Optionee shall, not later than the date as of which the exercise of this Stock Option becomes a taxable event for
Federal income tax purposes, pay to the Company or make arrangements satisfactory to the Administrator for payment of any Federal, state, and local taxes
required by law to be withheld on account of such taxable event. The Company shall have the authority to cause the minimum required tax withholding
obligation to be satisfied, in whole or in part, by withholding from shares of Stock to be issued to the Optionee a number of shares of Stock with an
aggregate Fair Market Value that would satisfy the minimum withholding amount due.
7.
No Obligation to Continue Employment. Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this
Agreement to continue the Optionee in employment and neither the Plan nor this Agreement shall interfere in any way with the right of the Company or
any Subsidiary to terminate the employment of the Optionee at any time.
8.
Integration. This Agreement constitutes the entire agreement between the parties with respect to this Stock Option and supersedes all
prior agreements and discussions between the parties concerning such subject matter.
9.
Data Privacy Consent. In order to administer the Plan and this Agreement and to implement or structure future equity grants, the
Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process any and all personal or professional
data, including but not limited to Social Security or other identification number, home address and telephone number, date of birth and other information
that is necessary or desirable for the administration of the Plan and/or this Agreement (the “Relevant Information”). By entering into this Agreement, the
Optionee (i) authorizes the Company to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy
rights the Optionee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information in
electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies consider appropriate. The
Optionee shall have access to, and the right to change, the Relevant Information. Relevant Information will only be used in accordance with applicable
law.
10.
Notices. Notices hereunder shall be mailed or delivered to the Company at its principal place of business and shall be mailed or
delivered to the Optionee at the address on file with the Company or, in either case, at such other address as one party may subsequently furnish to the other
party in writing.
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SCPHARMACEUTICALS INC.
By:
Title:
The foregoing Agreement is hereby accepted and the terms and conditions thereof hereby agreed to by the undersigned. Electronic acceptance of this
Agreement pursuant to the Company’s instructions to the Optionee (including through an online acceptance process) is acceptable.
Dated:
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Optionee’s Signature
Optionee’s name and address:
4
SCPHARMACEUTICALS INC.
AMENDED AND RESTATED
NON-EMPLOYEE DIRECTOR COMPENSATIONPOLICY
Exhibit 10.6
The purpose of this Amended and Restated Non-Employee Director Compensation Policy (this “Policy”) of scPharmaceuticals
Inc. (the “Company”), is to provide a total compensation package that enables the Company to attract and retain, on a long-term
basis, high-caliber directors who are not employees or officers of the Companyor its subsidiaries (each, a “Non-Employee
Director”). In furtherance of the purpose stated above, all Non-Employee Directors shall be paidcompensation for services
provided to the Company asset forth below, unless such Non-Employee Director declines the receipt of such cash or equity
compensation by written notice to the Company:
Cash Retainers
Annual Retainer for Board Membership: $40,000 for general availability and participation in meetings and conference calls
of our Board of Directors.
Additional Annual Retainer for Non-Executive Chair of the Board: $35,000
Additional Retainers for Committee Membership:
Audit Committee Chair: $20,000
Audit Committee member:
$10,000
Compensation Committee Chair:
$15,000
Compensation Committee member:
$7,500
Nominating and Corporate Governance Committee Chair:
$10,000
Nominating and Corporate Governance Committee member:
$5,000
Note: Chair and committee member retainers are in addition to retainers for members of the Board of Directors.
All retainers are paid quarterly in arrears, pro-rated based on the number of actual days served by the director during such
calendar quarter.
Equity Retainers
Initial Award: An initial, one-time equity award (the “Initial Award”) of an option to purchase 34,600 shares of the Company's
common stock, par value $0.0001 per share (“Common Stock”), to each new Non-Employee Director (who is initially elected
or appointed to the Board of Directors after the Effective Date (as defined below)) upon his or her election or
appointment to the Board of Directors, which shall vest 33% on first anniversary of grant, then the remainder shall vest ratably
monthly, provided, however, that all vesting shall cease if the director resigns from the Board of Directors or otherwise ceases
to serve as a director of the Company. Such stock option shall have a per share exercise price equal to the Fair Market Value
(as defined in the Company’s 2017 Stock Option and Incentive Plan (the “Plan”)) of the Company’s Common Stock on the
date of grant.
Annual Award: On each date of the Company’s Annual Meeting of Stockholders following the Effective Date (the “Annual
Meeting”), each continuing Non-Employee Director, other than a director receiving an Initial Award at such Annual Meeting,
will receive an annual equity award (the “Annual Award”) of an option to purchase 17,300 shares of Common Stock, which
shall vest in full upon the earlier to occur of the first anniversary of the date of grant or the date of the next Annual Meeting;
provided, however, that all vesting shall cease if the director resigns from the Board of Directors or otherwise ceases to serve as
a director, unless the Board of Directors determines that the circumstances warrant continuation of vesting. Such stock option
shall have a per share exercise price equal to the Fair Market Value (as defined in the Plan) of the Company’s Common Stock
on the date of grant.
Limits on Non-Employee Director Compensation
The limits on Non-Employee Director compensation contained in the Plan or in any other documents or policy, if any, shall
govern the compensation to be provided under this Policy. To the extent the compensation to be paid or provided under this
Policy to a Non-Employee Director would exceed such limits, the compensation shall be automatically reduced to the extent
necessary to ensure it complies with such limits.
Expenses
The Company will reimburse reasonable travel and related business expenses that an Non-Employee Director incurs for
attendance at all meetings of the Board and applicable meetings of committees, to the extent incurred and substantiated in
accordance with the policies, practices and procedures of the Company as in effect from time to time.
This Policy has been amended and restated in its entirety, effective as of January 1, 2023 (“Effective Date”).
SCPHARMACEUTICALS INC.
EMPLOYMENT AGREEMENT
Exhibit 10.11
This Employment Agreement (“Agreement”) is made as of the 16th day of November, 2017, between
scPharmaceuticals Inc., a Delaware corporation (the “Company”), and John H. Tucker (the “Executive”) and is effective as
of the closing of the Company’s first underwritten public offering of its equity securities pursuant to an effective
registration statement under the Securities Act of 1933, as amended (the “Effective Date”).
WHEREAS, the Company and the Executive are parties to an offer letter, dated January 16, 2017, as amended and
restated on January 24, 2017, and a Nondisclosure, Noncompetition, and Assignment of Intellectual Property Agreement,
dated as of February 2, 2017 (collectively, the “Prior Agreements”); and
WHEREAS, the parties intend to replace the Prior Agreements with this Agreement, effective as of the Effective
Date.
NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained and other good and
valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:
1.
Employment.
(a)
Term. The term of this Agreement shall commence on the Effective Date and continue until
terminated in accordance with the provisions hereof (the “Term”). The Executive’s employment with the Company will
continue to be “at will,” meaning that the Executive’s employment may be terminated by the Company or the Executive at
any time and for any reason subject to the terms of this Agreement.
(b)
Position and Duties. During the Term, the Executive shall serve as the Chief Executive Officer of
the Company, and shall have supervision and control over and responsibility for the day-to-day business and affairs of the
Company and shall have such other powers and duties as may from time to time be prescribed by the Board of Directors of
the
Company (the “Board”) or other authorized executive. The Executive shall devote his full working time and efforts to the
business and affairs of the Company. Notwithstanding the foregoing, the Executive may serve on other boards of directors,
with the approval of the Board, or engage in religious, charitable or other community activities as long as such services and
activities are disclosed to the Board and do not materially interfere with the Executive’s performance of his duties to the
Company as provided in this Agreement.
2.
Compensation and Related Matters.
(a)
Base Salary. During the Term, the Executive’s annual base salary shall be
$481,000. The Executive’s base salary shall be reviewed annually by the Board or the Compensation Committee of the Board
(the “Compensation Committee”). The base salary in
effect at any given time is referred to herein as “Base Salary.” The Base Salary shall be payable in a manner that is consistent
with the Company’s usual payroll practices for executive officers.
(b)
Incentive Compensation. During the Term, the Executive shall be eligible to receive cash incentive
compensation as determined by the Board or the Compensation Committee from time to time. The Executive’s initial target
annual incentive compensation shall be 50 percent of his Base Salary (the “Target Annual Incentive Compensation”). Except
as otherwise provided herein, to earn incentive compensation, the Executive must be employed by the Company on the day
such incentive compensation is paid.
(c)
Expenses. The Executive shall be entitled to receive prompt reimbursement for all reasonable
expenses incurred by him during the Term in performing services hereunder, in accordance with the policies and procedures
then in effect and established by the Company for its executive officers.
Other Benefits. During the Term, the Executive shall be eligible to participate in or receive
benefits under the Company’s employee benefit plans in effect from time to time, subject to the terms of such plans.
(d)
(e)
Vacations. During the Term, the Executive shall be entitled to paid vacation in accordance with the
Company’s policies and procedures. The Executive shall also be entitled to all paid holidays given by the Company to its
executive officers.
3.
Termination. During the Term, the Executive’s employment hereunder may be terminated without any
breach of this Agreement under the following circumstances:
death.
(a)
Death. The Executive’s employment hereunder shall terminate upon his
(b)
Disability. The Company may terminate the Executive’s employment if
he is disabled and unable to perform the essential functions of the Executive’s then existing position or positions under this
Agreement with or without reasonable accommodation for a period of 180 days (which need not be consecutive) in any 12-
month period. If any question shall arise as to whether during any period the Executive is disabled so as to be unable to
perform the essential functions of the Executive’s then existing position or positions with or without reasonable
accommodation, the Executive may, and at the request of the Company shall, submit to the Company a certification in
reasonable detail by a physician selected by the
Company to whom the Executive or the Executive’s guardian has no reasonable objection as to whether the Executive is so
disabled or how long such disability is expected to continue, and such certification shall for the purposes of this Agreement be
conclusive of the issue. The Executive shall cooperate with any reasonable request of the physician in connection with such
certification. If such question shall arise and the Executive shall fail to submit such certification, the Company’s
determination of such issue shall be binding on the Executive. Nothing in this Section 3(b) shall be construed to waive the
Executive’s rights, if any, under existing law including, without limitation, the Family and Medical Leave Act of 1993, 29
U.S.C. §2601 et seq. and the Americans with Disabilities Act, 42 U.S.C. §12101 et seq.
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(c)
Termination by Company for Cause. The Company may terminate the Executive’s employment
hereunder for Cause. For purposes of this Agreement, “Cause” shall mean: (i) conduct by the Executive constituting a material
act of misconduct in connection with the performance of his duties, including, without limitation, misappropriation of funds or
property of the Company or any of its subsidiaries or affiliates other than the occasional, customary and de minimis use of
Company property for personal purposes; (ii) the commission by the Executive of any felony or a misdemeanor involving
moral turpitude, deceit, dishonesty or fraud, or any conduct by the Executive that would reasonably be expected to result in
material injury or reputational harm to the Company or any of its subsidiaries or affiliates if he were retained in his position;
(iii) continued non-performance by the Executive of his duties hereunder (other than by reason of the Executive’s physical or
mental illness, incapacity or disability)
which has continued for more than 30 days following written notice of such non-performance from the Board; (iv) a breach by
the Executive of any of the provisions contained in Section 7 of this Agreement; (v) a material violation by the Executive of
the Company’s written employment policies; or (vi) failure to cooperate with a bona fide internal investigation or an
investigation by regulatory or law enforcement authorities, after being instructed by the Company to cooperate, or the willful
destruction or failure to preserve documents or other materials known to be relevant to such investigation or the inducement of
others to fail to cooperate or to produce documents or other materials in connection with such investigation.
(d)
Termination Without Cause. The Company may terminate the Executive’s employment
hereunder at any time without Cause. Any termination by the
Company of the Executive’s employment under this Agreement which does not constitute a termination for Cause under
Section 3(c) and does not result from the death or disability of the Executive under Section 3(a) or (b) shall be deemed a
termination without Cause.
(e)
Termination by the Executive. The Executive may terminate his employment hereunder at any time
for any reason, including but not limited to Good Reason. For purposes of this Agreement, “Good Reason” shall mean that
the Executive has complied with the “Good Reason Process” (hereinafter defined) following the occurrence of any of the
following events: (i) a material diminution in the Executive’s responsibilities, authority or duties; (ii) a material diminution in
the Executive’s Base Salary except for across-the-board salary reductions based on the Company’s financial performance
similarly affecting all or substantially all senior management employees of the Company; (iii) a material change in the
geographic location at which the Executive provides services to the Company; or (iv) the material breach of this Agreement
by the Company. “Good Reason Process” shall mean that (i) the Executive reasonably determines in good faith that a “Good
Reason” condition has occurred;
(ii) the Executive notifies the Company in writing of the first occurrence of the Good Reason condition within 60 days of the
first occurrence of such condition; (iii) the Executive cooperates in good faith with the Company’s efforts, for a period not less
than 30 days following such notice (the “Cure Period”), to remedy the condition; (iv) notwithstanding such efforts, the Good
Reason condition continues to exist; and (v) the Executive terminates his employment within 60 days after the end of the Cure
Period. If the Company cures the Good Reason condition during the Cure Period, Good Reason shall be deemed not to have
occurred.
Executive’s employment by the Company or any such termination
(f)
Notice of Termination. Except for termination as specified in Section 3(a), any termination of the
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by the Executive shall be communicated by written Notice of Termination to the other party hereto. For purposes of this
Agreement, a “Notice of Termination” shall mean a notice which shall indicate the specific termination provision in this
Agreement relied upon.
(g)
Date of Termination. “Date of Termination” shall mean: (i) if the Executive’s employment is
terminated by his death, the date of his death; (ii) if the Executive’s employment is terminated on account of disability under
Section 3(b) or by the Company for Cause under Section 3(c), the date on which Notice of Termination is given; (iii) if the
Executive’s employment is terminated by the Company under Section 3(d), the date on which a Notice of Termination is
given; (iv) if the Executive’s employment is terminated by the Executive under Section 3(e) without Good Reason, 30 days
after the date on which a Notice of Termination is given, and (v) if the Executive’s employment is terminated by the
Executive under Section 3(e) with Good Reason, the date on which a Notice of Termination is given after the end of the Cure
Period. Notwithstanding the foregoing, in the event that the Executive gives a Notice of Termination to the Company, the
Company may unilaterally accelerate the Date of Termination and such acceleration shall not result in a termination by the
Company for purposes of this Agreement.
4.
Compensation Upon Termination.
(a)
Termination Generally. If the Executive’s employment with the Company is terminated for any
reason, the Company shall pay or provide to the Executive (or to his authorized representative or estate) (i) any Base Salary
earned through the Date of Termination, unpaid expense reimbursements (subject to, and in accordance with, Section 2(c) of
this Agreement) and unused vacation that accrued through the Date of Termination on or before the time required by law but
in no event more than 30 days after the Executive’s Date of Termination; and (ii) any vested benefits the Executive may have
under any employee benefit plan of the Company through the Date of Termination, which vested benefits shall be paid and/or
provided in accordance with the terms of such employee benefit plans (collectively, the “Accrued Benefit”).
(b)
Termination by the Company Without Cause or by the Executive with Good Reason. During the
Term, if the Executive’s employment is terminated by the Company without Cause as provided in Section 3(d), or the
Executive terminates his employment for Good Reason as provided in Section 3(e), then the Company shall pay the Executive
his Accrued Benefit. In addition, subject to the Executive signing a separation agreement containing, among other provisions,
a general release of claims in favor of the Company and related persons and entities, confidentiality, return of property and
non-disparagement, in a form and manner satisfactory to the Company (the “Separation Agreement and Release”) and the
Separation Agreement and Release becoming irrevocable and fully effective, all within 60 days after the Date of Termination
(or such shorter time period provided in the Separation Agreement and Release):
the Company shall pay the Executive an amount equal to the sum of (A) the Executive’s
Base Salary plus (B) the Executive’s Average Incentive Compensation (the “Severance Amount”). For purposes of
this Agreement, “Average Incentive Compensation” shall mean the average of the Target Annual Incentive
(i)
4
Compensation received by the Executive for the three immediately preceding fiscal years. In no event shall “Average
Incentive Compensation” include any sign-on bonus, retention bonus or any other special bonus. Notwithstanding the
foregoing, if the Executive breaches any of the provisions contained in Section 7 of this Agreement, all payments of the
Severance Amount shall immediately cease;
(ii)
[Reserved];
(iii)
if the Executive was participating in the Company’s group health plan immediately prior to
the Date of Termination and elects COBRA health continuation, then the Company shall pay to the Executive a
monthly cash payment for 12 months or the Executive’s COBRA health continuation period, whichever ends earlier,
in an amount equal to the monthly employer contribution that the Company would have made to provide health
insurance to the Executive if the Executive had remained employed by the Company; and
(iv)
the amounts payable under Section 4(b)(i) and (iii) shall be paid out in substantially equal
installments in accordance with the Company’s payroll practice over 12 months commencing within 60 days after the
Date of Termination; provided, however, that if the 60-day period begins in one calendar year and ends in a second
calendar year, the Severance Amount shall begin to be paid in the second calendar year by the last day of such 60-day
period; provided, further, that the initial payment shall include a catch-up payment to cover amounts retroactive to the
day immediately
following the Date of Termination. Each payment pursuant to this Agreement is intended to constitute a separate
payment for purposes of Treasury Regulation Section 1.409A- 2(b)(2).
5.
Change in Control Payment. The provisions of this Section 5 set forth certain terms of an agreement
reached between the Executive and the Company regarding the Executive’s rights and obligations upon the occurrence of a
Change in Control of the Company. These provisions are intended to assure and encourage in advance the Executive’s
continued attention and dedication to his assigned duties and his objectivity during the pendency and after the occurrence of
any such event. These provisions shall apply in lieu of, and expressly supersede, the provisions of Section 4(b) regarding
severance pay and benefits upon a
termination of employment, if such termination of employment occurs within 12 months after the occurrence of the first event
constituting a Change in Control. These provisions shall terminate and be of no further force or effect beginning 12 months after
the occurrence of a Change in Control.
(a)
Change in Control. During the Term, if within 12 months after a Change in Control, the
Executive’s employment is terminated by the Company without Cause as provided in Section 3(d) or the Executive
terminates his employment for Good Reason as provided in Section 3(e), then, subject to the signing of the Separation
Agreement and Release by the Executive and the Separation Agreement and Release becoming irrevocable and fully
effective, all within 60 days after the Date of Termination (or such shorter time period provided in the Separation Agreement
and Release):
5
(i)
the Company shall pay the Executive a lump sum in cash in an amount equal to one and
a half (1.5) times the sum of (A) the Executive’s current Base Salary (or the Executive’s Base Salary in effect
immediately prior to the Change in
Control, if higher) plus (B) the Executive’s Average Incentive Compensation;
notwithstanding anything to the contrary in any applicable option agreement or stock-based
award agreement, all time-based stock options and other time- based stock-based awards held by the Executive shall
immediately accelerate and become fully exercisable or nonforfeitable as of the Date of Termination;
(ii)
(iii)
if the Executive was participating in the Company’s group health plan immediately prior to
the Date of Termination and elects COBRA health continuation, then the Company shall pay to the Executive a
monthly cash payment for 18 months or the Executive’s COBRA health continuation period, whichever ends earlier,
in an amount equal to the monthly employer contribution that the Company would have made to provide health
insurance to the Executive if the Executive had remained employed by the Company; and
(iv)
The amounts payable under Section 5(a)(i) and (iii) shall be paid or commence to be paid
within 60 days after the Date of Termination; provided, however, that if the 60-day period begins in one calendar year
and ends in a second calendar year, such payment shall be paid or commence to be paid in the second calendar year by
the last day of such 60-day period.
(b)
Additional Limitation.
(i)
Anything in this Agreement to the contrary notwithstanding, in the event that the amount of
any compensation, payment or distribution by the Company to or for the benefit of the Executive, whether paid or
payable or distributed or distributable pursuant to the terms of this Agreement or otherwise, calculated in a manner
consistent with Section 280G of the Internal Revenue Code of 1986, as amended (the “Code”) and the applicable
regulations thereunder (the “Aggregate Payments”), would be subject to the excise tax imposed by Section 4999 of
the Code, then the Aggregate Payments shall be reduced (but not below zero) so that the sum of all of the Aggregate
Payments shall be
$1.00 less than the amount at which the Executive becomes subject to the excise tax imposed by Section 4999 of the
Code; provided that such reduction shall only occur if it would result in the Executive receiving a higher After Tax
Amount (as defined below) than the Executive would receive if the Aggregate Payments were not subject to such
reduction. In such event, the Aggregate Payments shall be reduced in the following order, in each case, in reverse
chronological order beginning with the Aggregate Payments that are to be paid the furthest in time from
consummation of the transaction that is subject to Section 280G of the Code: (1) cash payments not subject to
Section 409A of the Code; (2) cash payments subject to Section 409A of the Code; (3) equity-
based payments and acceleration; and (4) non-cash forms of benefits; provided that in the case of all the foregoing
Aggregate Payments all amounts or payments that are not subject to calculation under Treas. Reg. §1.280G-1, Q&A-
24(b) or (c) shall be reduced
6
before any amounts that are subject to calculation under Treas. Reg. §1.280G-1, Q&A- 24(b) or (c).
(ii)
For purposes of this Section 5(b), the “After Tax Amount” means the amount of the
Aggregate Payments less all federal, state, and local income, excise and employment taxes imposed on the Executive
as a result of the Executive’s receipt of the Aggregate Payments. For purposes of determining the After Tax Amount,
the Executive shall be deemed to pay federal income taxes at the highest marginal rate of federal income taxation
applicable to individuals for the calendar year in which the determination is to be made, and state and local income
taxes at the highest marginal rates of individual taxation in each applicable state and locality, net of the maximum
reduction in federal income taxes which could be obtained from deduction of such state and local taxes.
(iii)
The determination as to whether a reduction in the Aggregate Payments shall be made
pursuant to Section 5(b)(i) shall be made by a nationally recognized accounting firm selected by the Company (the
“Accounting Firm”), which shall provide detailed supporting calculations both to the Company and the Executive
within 15 business days of the Date of Termination, if applicable, or at such earlier time as is reasonably requested
by the Company or the Executive. Any determination by the Accounting Firm shall be binding upon the Company
and the Executive.
(c)
Definitions. For purposes of this Section 5, the following terms shall have the following meanings:
“Change in Control” shall mean any of the following:
(i)
any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange
Act of 1934, as amended (the “Act”) (other than the Company, any of its subsidiaries, or any trustee, fiduciary or
other person or entity holding securities under any employee benefit plan or trust of the Company or any of its
subsidiaries), together with all “affiliates” and “associates” (as such terms are defined in Rule 12b-2 under the Act) of
such person, shall become the “beneficial owner” (as such term is defined in Rule 13d-3 under the Act), directly or
indirectly, of securities of the Company representing 50 percent or more of the combined voting power of the
Company’s then outstanding securities having the right to vote in an election of the Board (“Voting Securities”) (in
such case other than as a result of an acquisition of securities directly from the Company); or
(ii)
the date a majority of the members of the Board is replaced during any 12-month period by
directors whose appointment or election is not endorsed by a majority of the members of the Board before the date
of the appointment or election; or
(iii)
the consummation of (A) any consolidation or merger of the Company where the
stockholders of the Company, immediately prior to the consolidation or merger, would not, immediately after the
consolidation or merger, beneficially own (as such term is defined in Rule 13d-3 under the Act), directly or indirectly,
shares representing in the aggregate more than 50 percent of the voting shares of the Company
7
issuing cash or securities in the consolidation or merger (or of its ultimate parent corporation, if any), or (B) any sale
or other transfer (in one transaction or a series of transactions contemplated or arranged by any party as a single plan)
of all or substantially all of the assets of the Company.
Notwithstanding the foregoing, a “Change in Control” shall not be deemed to have occurred for purposes of the
foregoing clause (i) solely as the result of an acquisition of securities by the Company which, by reducing the number of shares
of Voting Securities outstanding, increases the proportionate number of Voting Securities beneficially owned by any person to
50 percent or more of the combined voting power of all of the then outstanding Voting Securities; provided, however, that if
any person referred to in this sentence shall thereafter become the beneficial owner of any additional shares of Voting
Securities (other than pursuant to a stock split, stock dividend, or similar transaction or as a result of an acquisition of
securities directly from the Company) and immediately thereafter beneficially owns 50 percent or more of the combined voting
power of all of the then outstanding Voting Securities, then a “Change in
Control” shall be deemed to have occurred for purposes of the foregoing clause (i).
6.
Section 409A.
(a)
Anything in this Agreement to the contrary notwithstanding, if at the time of the Executive’s
separation from service within the meaning of Section 409A of the Code, the Company determines that the Executive is a
“specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit
that the Executive becomes entitled to under this Agreement on account of the Executive’s separation from service would be
considered deferred compensation otherwise subject to the 20 percent additional tax imposed pursuant to Section 409A(a) of
the Code as a result of the application of Section 409A(a)(2)(B)(i) of the Code, such payment shall not be payable and such
benefit shall not be provided until the date that is the earlier of (A) six months and one day after the Executive’s separation
from service, or (B) the Executive’s death. If any such delayed cash payment is otherwise payable on an installment basis, the
first payment shall include a catch-up payment covering amounts that would otherwise have been paid during the six-month
period but for the application of this provision, and the balance of the installments shall be payable in accordance with their
original schedule.
(b)
All in-kind benefits provided and expenses eligible for reimbursement under this Agreement shall be
provided by the Company or incurred by the Executive during the time periods set forth in this Agreement. All
reimbursements shall be paid as soon as administratively practicable, but in no event shall any reimbursement be paid after the
last day of the taxable year following the taxable year in which the expense was incurred. The amount of
in-kind benefits provided or reimbursable expenses incurred in one taxable year shall not affect the in-kind benefits to be
provided or the expenses eligible for reimbursement in any other taxable year (except for any lifetime or other aggregate
limitation applicable to medical expenses). Such right to reimbursement or in-kind benefits is not subject to liquidation or
exchange for another benefit.
deferred compensation” under Section 409A of the Code, and to the
(c)
To the extent that any payment or benefit described in this Agreement constitutes “non-qualified
8
extent that such payment or benefit is payable upon the Executive’s termination of employment, then such payments or
benefits shall be payable only upon the Executive’s “separation from service.” The determination of whether and when a
separation from service has occurred shall be made in accordance with the presumptions set forth in Treasury Regulation
Section
1.409A-1(h).
(d)
The parties intend that this Agreement will be administered in accordance with Section 409A of the
Code. To the extent that any provision of this Agreement is ambiguous as to its compliance with Section 409A of the Code,
the provision shall be read in such a manner so that all payments hereunder comply with Section 409A of the Code. Each
payment pursuant to this Agreement is intended to constitute a separate payment for purposes of Treasury Regulation Section
1.409A-2(b)(2). The parties agree that this Agreement may be amended, as reasonably requested by either party, and as may
be necessary to fully comply with Section 409A of the Code and all related rules and regulations in order to preserve the
payments and benefits provided hereunder without additional cost to either party.
The Company makes no representation or warranty and shall have no liability to the Executive or
any other person if any provisions of this Agreement are determined to constitute deferred compensation subject to Section
409A of the Code but do not satisfy an exemption from, or the conditions of, such Section.
(e)
7.
Confidential Information, Noncompetition and Cooperation.
(a)
Confidential Information. As used in this Agreement, “Confidential Information” means information
belonging to the Company which is of value to the Company in the course of conducting its business and the disclosure of
which could result in a competitive or other disadvantage to the Company. Confidential Information includes, without
limitation, financial information, reports, and forecasts; inventions, improvements and other intellectual property; trade
secrets; know-how; designs, processes or formulae; software; market or sales information or plans; customer lists; and
business plans, prospects and opportunities (such as possible acquisitions or dispositions of businesses or facilities) which
have been discussed or considered by the management of the Company. Confidential Information includes information
developed by the Executive in the course of the Executive’s employment by the Company, as well as other information to
which the Executive may have access in connection with the Executive’s employment. Confidential Information also includes
the confidential information of others with which the Company has a business relationship. Notwithstanding the foregoing,
Confidential Information does not include information in the public domain, unless due to breach of the Executive’s duties
under Section 7(b).
(b)
Confidentiality. The Executive understands and agrees that the Executive’s employment creates a
relationship of confidence and trust between the Executive and the Company with respect to all Confidential Information. At
all times, both during the Executive’s employment with the Company and after its termination, the Executive will keep in
confidence and trust all such Confidential Information,and will not use or disclose any such Confidential Information
without the written consent of the Company, except as may be necessary in the ordinary course of performing the
Executive’s duties to the Company. For avoidance of doubt, nothing in this Agreement shall be interpreted or applied to
prohibit the
9
Executive from making any good faith report to any governmental agency or other governmental entity concerning any act or
omission that the Executive reasonably believes constitutes a possible violation of federal or state law or making other
disclosures that are protected under the anti-retaliation or whistleblower provisions of applicable federal or state law or
regulation. In addition, for the avoidance of doubt, pursuant to the federal Defend Trade Secrets Act of 2016, the Executive
shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that
(i) is made (A) in confidence to a federal, state or local government official, either directly or indirectly, or to an attorney and
(B) solely for the purpose of reporting or investigating a suspected violation of law; or (ii) is made in a complaint or other
document filed in a lawsuit or other proceeding, if such filing is made under seal.
(c)
Documents, Records, etc. All documents, records, data, apparatus, equipment and other physical
property, whether or not pertaining to Confidential Information, which are furnished to the Executive by the Company or are
produced by the Executive in connection with the Executive’s employment will be and remain the sole property of the
Company. The Executive will return to the Company all such materials and property as and when requested by the Company.
In any event, the Executive will return all such materials and property immediately upon termination of the Executive’s
employment for any reason. The Executive will not retain with the Executive any such material or property or any copies
thereof after such termination.
(d)
Noncompetition and Nonsolicitation. During the Executive’s employment with the Company and
for 12 months thereafter, regardless of the reason for the termination, the Executive (i) will not, directly or indirectly, whether
as owner, partner, shareholder, consultant, agent, employee, co-venturer or otherwise, engage, participate, assist or invest in
any Competing Business (as hereinafter defined); (ii) will refrain from directly or indirectly employing, attempting to employ,
recruiting or otherwise soliciting, inducing or influencing any person to leave employment with the Company (other than
terminations of employment of subordinate employees undertaken in the course of the Executive’s employment with the
Company); and (iii) will refrain from soliciting or encouraging any customer or supplier to terminate or otherwise modify
adversely its business relationship with the Company. The Executive understands that the restrictions set forth in this Section
7(d) are intended to protect the Company’s interest in its Confidential Information and established employee, customer and
supplier relationships and goodwill, and agrees that such restrictions are reasonable and appropriate for this purpose. For
purposes of this Agreement, the term “Competing Business” shall mean a business conducted anywhere which is competitive
with any business which the Company or any of its affiliates conducts or proposes to conduct at any time during the
employment of the Executive. Notwithstanding the foregoing, the Executive may own up to one percent (1%) of the
outstanding stock of a publicly held corporation which constitutes or is affiliated with a Competing Business.
(e)
Third-Party Agreements and Rights. The Executive hereby confirms that the Executive is not
bound by the terms of any agreement with any previous employer or other party which restricts in any way the Executive’s
use or disclosure of information or the Executive’s engagement in any business. The Executive represents to the Company
that the Executive’s execution of this Agreement, the Executive’s employment with the Company and the performance of the
Executive’s proposed duties for the Company will not violate any
10
obligations the Executive may have to any such previous employer or other party. In the Executive’s work for the Company,
the Executive will not disclose or make use of any information in violation of any agreements with or rights of any such
previous employer or other party, and the Executive will not bring to the premises of the Company any copies or other
tangible embodiments of non-public information belonging to or obtained from any such previous employment or other party.
(f)
Litigation and Regulatory Cooperation. During and after the Executive’s employment, the
Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or
which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired
while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or
actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as
a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the
Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or
local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the
Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket
expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).
(g)
Relief. The Executive agrees that it would be difficult to measure any damages caused to the
Company which might result from any breach by the Executive of the promises set forth in this Section 7, and that in any
event money damages would be an inadequate remedy for any such breach. Accordingly, subject to Section 8 of this
Agreement, the Executive agrees that if the Executive breaches, or proposes to breach, any portion of this Agreement, the
Company shall be entitled, in addition to all other remedies that it may have, to an injunction or other appropriate equitable
relief to restrain any such breach without showing or proving any actual damage to the Company. In addition, in the event the
Executive breaches this Section 7 during a period when he is receiving severance payments pursuant to Section 4 or Section 5
hereof, the Company shall have the right to suspend or terminate such severance payments. Such suspension or termination
shall not limit the Company’s other options with respect to relief for such breach and shall not relieve the Executive of his
duties under this Agreement.
(h)
Protected Disclosures and Other Protected Action. Nothing contained in this Agreement limits the
Executive’s ability to communicate with any federal, state or local governmental agency or commission, including to
provide documents or other information, without notice to the Company.
8.
Arbitration of Disputes. Any controversy or claim arising out of or relating to this Agreement or the breach
thereof or otherwise arising out of the Executive’s employment or the termination of that employment (including, without
limitation, any claims of unlawful employment discrimination whether based on age or otherwise) shall, to the fullest extent
permitted by law, be settled by arbitration in any forum and form agreed upon by the parties or, in the absence of such an
agreement, under the auspices of the American Arbitration Association (“AAA”) in Boston, Massachusetts in accordance with
the Employment Dispute Resolution
11
Rules of the AAA, including, but not limited to, the rules and procedures applicable to the selection of arbitrators. In the event
that any person or entity other than the Executive or the Company may be a party with regard to any such controversy or
claim, such controversy or claim shall be submitted to arbitration subject to such other person or entity’s agreement.
Judgment upon the award rendered by the arbitrator may be entered in any court having jurisdiction thereof. This Section 8
shall be specifically enforceable. Notwithstanding the foregoing, this Section 8 shall not preclude either party from pursuing a
court action for the sole purpose of obtaining a temporary restraining order or a preliminary injunction in circumstances in
which such relief is appropriate; provided that any other relief shall be pursued through an arbitration proceeding pursuant to
this Section 8.
9.
Consent to Jurisdiction. To the extent that any court action is permitted consistent with or to enforce
Section 8 of this Agreement, the parties hereby consent to the jurisdiction of the Superior Court of the Commonwealth of
Massachusetts and the United States District Court for the District of Massachusetts. Accordingly, with respect to any such
court action, the Executive (a) submits to the personal jurisdiction of such courts; (b) consents to service of process; and (c)
waives any other requirement (whether imposed by statute, rule of court, or otherwise) with respect to personal jurisdiction or
service of process.
10.
Integration. This Agreement constitutes the entire agreement between the parties with respect to the subject
matter hereof and supersedes all prior agreements between the parties concerning such subject matter, including the Prior
Agreements.
11.
Withholding. All payments made by the Company to the Executive under this Agreement shall be net
of any tax or other amounts required to be withheld by the Company under applicable law.
12.
Successor to the Executive. This Agreement shall inure to the benefit of and be enforceable by the
Executive’s personal representatives, executors, administrators, heirs, distributees, devisees and legatees. In the event of the
Executive’s death after his termination of employment but prior to the completion by the Company of all payments due to
him under this Agreement, the Company shall continue such payments to the Executive’s beneficiary designated in writing to
the Company prior to his death (or to his estate, if the Executive fails to make such designation).
13.
Enforceability. If any portion or provision of this Agreement (including, without limitation, any portion or
provision of any section of this Agreement) shall to any extent be declared illegal or unenforceable by a court of competent
jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than
those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of
this Agreement shall be valid and enforceable to the fullest extent permitted by law.
14.
Survival. The provisions of this Agreement shall survive the termination of this Agreement and/or the
termination of the Executive’s employment to the extent necessary to effectuate the terms contained herein.
12
15.
Waiver. No waiver of any provision hereof shall be effective unless made in writing and signed by the
waiving party. The failure of any party to require the performance of any term or obligation of this Agreement, or the waiver
by any party of any breach of this Agreement, shall not prevent any subsequent enforcement of such term or obligation or be
deemed a waiver of any subsequent breach.
16.
Notices. Any notices, requests, demands and other communications provided for by this Agreement shall
be sufficient if in writing and delivered in person or sent by a nationally recognized overnight courier service or by registered
or certified mail, postage prepaid, return receipt requested, to the Executive at the last address the Executive has filed in
writing with the Company or, in the case of the Company, at its main offices, attention of the Board.
17.
Amendment. This Agreement may be amended or modified only by a written instrument signed by the
Executive and by a duly authorized representative of the Company.
18.
Governing Law. This is a Massachusetts contract and shall be construed under and be governed in all
respects by the laws of the Commonwealth of Massachusetts, without giving effect to the conflict of laws principles
thereof.
19.
Counterparts. This Agreement may be executed in any number of counterparts, each of which when so
executed and delivered shall be taken to be an original; but such counterparts shall together constitute one and the same
document.
20.
Successor to Company. The Company shall require any successor (whether direct or indirect, by purchase,
merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company expressly to assume and
agree to perform this Agreement to the same extent that the Company would be required to perform it if no succession had
taken place. Failure of the Company to obtain an assumption of this Agreement at or prior to the effectiveness of any
succession shall be a material breach of this Agreement.
21.
Gender Neutral. Wherever used herein, a pronoun in the masculine gender shall be considered as
including the feminine gender unless the context clearly indicates otherwise.
13
IN WITNESS WHEREOF, the parties have executed this Agreement effective on the date and year first above written.
By: /s/ Troy Ignelzi
Name: Troy lgnelzi
Its: Chief Financial Officer
EXECUTIVE
/s/ John H. Tucker
John H. Tucker
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the Registration Statements (Nos. 333-263762, 333-254636, 333-237361, 333-229122, 333-
227071 and 333-221677) on Forms S-8 and the Registration Statement (No. 333-254637) on Form S-3 of scPharmaceuticals Inc. of our
report dated March 22, 2023, relating to the consolidated financial statements of scPharmaceuticals Inc., appearing in this Annual Report on
Form 10-K of scPharmaceuticals Inc. for the year ended December 31, 2022.
Exhibit 23.1
/s/ RSM US LLP
Boston, Massachusetts
March 22, 2023
CERTIFICATION
Exhibit 31.1
I, John H. Tucker, certify that:
1.
2.
3.
4.
I have reviewed this Annual Report on Form 10-K of scPharmaceuticals Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under
our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on
such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the
equivalent functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date: March 22, 2023
By:
/s/ John H. Tucker
John H. Tucker
President and Chief Executive Officer (Principal Executive
Officer)
CERTIFICATION
Exhibit 31.2
I, Rachael Nokes, certify that:
1.
2.
3.
4.
I have reviewed this Annual Report on Form 10-K of scPharmaceuticals Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under
our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on
such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the
equivalent functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date: March 22, 2023
By:
/s/ Rachael Nokes
Rachael Nokes
Chief Financial Officer (Principal Financial Officer)
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the Annual Report of scPharmaceuticals Inc. (the “Company”) on Form 10-K for the year ended December 31, 2022
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted
pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
(1)
(2)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
Date: March 22, 2023
By:
/s/ John H. Tucker
* This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of
that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
John H. Tucker
President and Chief Executive Officer (Principal Executive
Officer)
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with the Annual Report of scPharmaceuticals Inc. (the “Company”) on Form 10-K for the year ended December 31, 2022
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted
pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
(1)
(2)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
Date: March 22, 2023
By:
/s/ Rachael Nokes
Rachael Nokes
Chief Financial Officer (Principal Financial Officer)
* This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of
that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.