1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
For the quarterly period ended
OR
For the transition period from to
Commission file number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
(Zip Code) |
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(Address of principal executive office) |
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Registrant’s telephone number, including area code: (
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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.
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).
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 |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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. ☐
2
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 13, 2024, the Registrant had
i
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q ("Quarterly Report") 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 Quarterly Report are forward-looking statements, including, but not limited to, statements about the commercialization of FUROSCIX, including the timing and progress thereof, the timing or likelihood of regulatory filings and approvals, the expansion of the FUROSCIX indication to include New York Heart Association Class IV heart failure patients, the potential development of an autoinjector and related benefits and timing thereof, including as related to a sNDA application, the potential expansion of the FUROSCIX indication to include treatment of edema in patients with chronic kidney disease, our plans to develop and commercialize our product candidates, the timing of our ongoing or planned clinical trials, the clinical utility of our product candidates, expectations surrounding manufacturing capabilities and supply chain matters, our commercialization capabilities and strategy, the sufficiency of our cash and cash equivalents and our ability to raise additional capital to fund our operations, our ability to remediate any material weakness, our future financial performance, the anticipated impact of 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 Quarterly Report 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, among other things:
i
ii
If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, then 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 Quarterly Report.
ii
iii
SCPHARMACEUTICALS INC.
INDEX
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Item 1. |
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Condensed Consolidated Financial Statements (unaudited) |
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Condensed Consolidated Balance Sheets as of December 31, 2023 and June 30, 2024 |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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30 |
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Item 4. |
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30 |
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Item 1. |
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32 |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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33 |
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34 |
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iii
4
PART I — FINANCIAL INFORMATION
SCPHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
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December 31, |
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June 30, |
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2023 |
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2024 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term investments |
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- |
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Accounts receivable, net |
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Inventory, net |
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Prepaid expenses |
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Deposits and other current assets |
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Total current assets |
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Property and equipment, net |
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Right-of-use lease assets - operating, net |
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Deposits and other assets |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Lease obligation - operating, short-term |
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Other current liabilities |
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Total current liabilities |
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Term loan, long-term |
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Derivative liability |
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Lease obligation - operating, long-term |
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Other liabilities |
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Total liabilities |
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(Note 12) |
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Stockholders’ equity |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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Accumulated other comprehensive income |
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( |
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- |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
5
SCPHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2023 |
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2024 |
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2023 |
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2024 |
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$ |
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$ |
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$ |
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$ |
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Operating expenses: |
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Cost of product revenues |
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Research and development |
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Selling, general and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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Other income (expense) |
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Interest income |
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Interest expense |
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( |
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Net loss |
$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Net loss per share — basic and diluted |
$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Weighted average common shares outstanding — basic and diluted |
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Other comprehensive loss: |
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Unrealized loss on short-term investments |
$ |
( |
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$ |
- |
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$ |
( |
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$ |
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Comprehensive loss |
$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
6
SCPHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands, except share amounts)
(Unaudited)
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ADDITIONAL |
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OTHER |
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TOTAL |
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COMMON STOCK |
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PAID-IN |
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ACCUMULATED |
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COMPREHENSIVE |
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STOCKHOLDERS' |
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SHARES |
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AMOUNT |
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CAPITAL |
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DEFICIT |
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INCOME (LOSS) |
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EQUITY |
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At December 31, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Issuance of common stock upon exercise |
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— |
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— |
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— |
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Vesting of restricted stock |
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— |
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( |
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— |
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— |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized gain on short-term investments |
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— |
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— |
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— |
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— |
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At March 31, 2024 |
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( |
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— |
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Net loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Issuance of common stock through |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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At June 30, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
— |
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$ |
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At December 31, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Issuance of common stock under at-the-market |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized loss on short-term investments |
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— |
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— |
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— |
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— |
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( |
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( |
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At March 31, 2023 |
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( |
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Net loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Issuance of common stock under at-the-market |
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— |
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— |
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— |
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Issuance of common stock upon exercise |
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— |
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— |
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— |
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Issuance of common stock through |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unrealized loss on short-term investments |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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At June 30, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
( |
) |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
7
SCPHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Six Months Ended June 30, |
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2023 |
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2024 |
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Cash flows from operating activities |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to cash used in operating activities |
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Depreciation expense |
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Amortization expense - right-of-use leased assets - operating |
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Accretion on short-term investments |
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( |
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( |
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Allowance for excess, damaged and obsolete inventory |
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— |
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Stock-based compensation |
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Non-cash interest expense |
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Fair value adjustment to derivative liability |
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( |
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( |
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Changes in operating assets and liabilities |
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Accounts receivable |
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( |
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( |
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Inventory |
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( |
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( |
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Prepaid expenses and other assets |
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( |
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Accounts payable, accrued expenses and other liabilities |
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( |
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( |
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Net cash used in operating activities |
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( |
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( |
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Cash flows from investing activities |
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Purchases of property and equipment |
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( |
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- |
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Maturities of short-term investments |
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Purchases of short-term investments |
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( |
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- |
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Net cash provided by investing activities |
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Cash flows from financing activities |
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Proceeds from at-the-market offering, net |
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— |
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Proceeds from employee stock purchase plan |
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Proceeds from the exercise of vested stock options |
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Settlement of restricted stock units for tax withholding obligations |
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— |
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( |
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Net cash provided by financing activities |
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Net increase (decrease) in cash and cash equivalents |
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( |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
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$ |
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$ |
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Supplemental cash flow information |
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Interest paid |
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$ |
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$ |
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Taxes paid |
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$ |
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$ |
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Supplemental disclosure of non-cash activities |
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Transfer of issuance costs from other noncurrent assets to equity |
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$ |
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$ |
— |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
8
SCPHARMACEUTICALS INC.
Notes to Unaudited Condensed Consolidated Financial Statements
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 condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information 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 condensed consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiary, scPharmaceuticals Securities Corporation. Certain information and disclosures normally included in financial statements in accordance with U.S. GAAP have been condensed or omitted. Accordingly, these condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and related notes for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2024. The Company has determined that it operates in one segment.
The accompanying condensed consolidated balance sheet as of June 30, 2024, the condensed consolidated statements of operations and comprehensive loss and stockholders’ equity for the three and six months ended June 30, 2023 and 2024 and condensed consolidated statements of cash flows for the six months ended June 30, 2023 and 2024 are unaudited. The unaudited condensed consolidated financial statements have been prepared on a basis consistent with that used to prepare the Company’s audited annual financial statements and include, in the opinion of management, adjustments, consisting of normal recurring items, necessary for the fair statement of the condensed consolidated financial statements. The operating results for the three and six months ended June 30, 2024 are not necessarily indicative of the results expected for the full year ending December 31, 2024.
Liquidity
As of June 30, 2024, the Company had an accumulated deficit of approximately $
On October 13, 2022, the Company entered into a Credit Agreement and Guaranty (the "Oaktree Agreement") with, among others, the lenders from time to time party thereto and Oaktree Fund Administration, LLC, in its capacity as administrative agent for the lenders (Note 9). On August 9, 2024 (the "Closing Date"), the Company entered into a Credit Agreement and Guaranty (the "Credit Agreement") with, among others, the guarantors from time to time party thereto, the lenders from time to time party thereto (the "Lenders"), and Perceptive Credit Holdings IV, LP, in its capacity as administrative agent for the Lenders (in such capacity, the "Agent") (Note 13). On the Closing Date, the Company also entered into a revenue participation right purchase and sale agreement (the "Revenue Purchase and Sale Agreement") with Perceptive Credit Holdings IV, LP (the "Purchaser") for a purchase price of $
On August 12, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC and TD Securities (USA) LLC, as representatives of the several underwriters named in Schedule A thereto (collectively, the
8
9
“Underwriters”), relating to an underwritten offering of
Historically, the Company has financed its operations to date from proceeds from the sale of common stock, preferred stock and the incurrence of debt. The Company plans to continue to fund its operations through cash and cash equivalents on hand, as well as through future equity offerings, including access to funds pursuant to an at-the-market offering program with Cowen and Company, LLC (Note 10), debt financings and other third-party funding. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to the Company. Even if the Company raises additional capital, it may also be required to modify, delay or abandon some of its plans which could have a material adverse effect on the Company’s business, operating results and financial condition and the Company’s ability to achieve its intended business objectives. Any of these actions could materially harm the Company’s business, results of operations and future prospects.
The Company's existing cash and cash equivalents, including the available proceeds from the Credit Agreement, the Revenue Purchase and Sale Agreement, and the Offering, will be sufficient to meet its cash commitments for at least the next 12 months after the date that the interim condensed consolidated financial statements are issued. Additionally, the Company expects to have access to funds pursuant to an at-the-market offering program with Cowen and Company, LLC (Note 10), or could otherwise seek additional funding through a combination of public or private equity offerings if it believes additional resources are needed. Additional financing may not be available on a timely basis on terms acceptable to the Company, or at all.
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 reported periods. Actual results could differ from those estimates.
Cash and Cash Equivalents
Cash and cash equivalents consists of bank deposits 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’s cash and cash equivalent accounts, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts.
Accounts Receivable
Accounts receivable are recorded net of any estimated expected credit losses. The Company's measurement of expected credit losses is based on relevant information about past events, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The Company does not currently have a material credit loss allowance for uncollectible trade receivables.
Concentration of Credit Risk
Customer and Supplier Concentration
The Company has a limited number of specialty pharmacy customers and distributors. As of December 31, 2023 and June 30, 2024,
9
10
The Company has a limited number suppliers and contract manufacturers utilized in the production of its product. As of December 31, 2023 and June 30, 2024,
The Company depends on suppliers for raw materials, active pharmaceutical ingredients ("API"), and other components that are subject to stringent FDA requirements. Some of these materials may only be available from one or a limited number of sources. Establishing additional or replacement suppliers may take a substantial period of time, as suppliers must be approved by the FDA. If the Company is unable to secure, on a timely basis, sufficient quantities of the materials it depends on to manufacture its products, it could have a materially adverse effect on the Company's business, financial condition and results of operations.
Investments
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. 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.
Debt Issuance Costs
Revenue Recognition
The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Accounting Standards Codification ("ASC") Topic 606, Revenue from Contracts with Customer (“Topic 606”), the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each
10
11
contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. The Company has identified one performance obligation, the delivery of FUROSCIX to its customers. The Company has not incurred any incremental costs associated with obtaining contracts with customers. The Company’s revenues consist solely of the sale of FUROSCIX to customers in the United States.
Product Net Sales
FUROSCIX was approved by the FDA on October 7, 2022. The Company launched sales of FUROSCIX in the first quarter of 2023 and its customers consist of specialty pharmacies (“SPs”) and specialty distributors ("SDs"). The Company recognizes revenue from product sales at a point in time, typically upon receipt of product at the SPs and SDs, the date at which the rights, title, interest and risk of loss are transferred. Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration that result from (a) sales discounts, (b) rebates (c) co-pay assistance, and (d) product returns. Reserves are established for the estimates of variable consideration based on the amounts earned or to be claimed on the related sales. The reserves for variable consideration are reflected as either as a reduction to the related account receivable or as an accrued liability, depending on how the consideration is settled. The amount of variable consideration that is included in the transaction price may be constrained and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results vary from its estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.
Sales Discounts: Sales discounts are agreed-upon discounts, from negotiated contracts, taken directly off the Company’s sales invoices. Sales discounts are recorded as an offset to revenue based on contractual terms at the time revenue from the sale is recognized.
Rebates: Allowance for rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare Part D prescription drug benefit, TRICARE program and contractual rebates with commercial payers. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or statutory requirements. The allowance for rebates is based on contracted or statutory discount rates and expected utilization by benefit plan participants. The Company’s estimates for expected utilization of rebates are based on utilization data received from the SPs since product launch. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for prior quarters’ unpaid rebates. If actual future rebates vary from estimates, the Company may need to adjust prior period accruals, which would affect revenue in the period of adjustment.
Co-Payment Assistance: The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirements. Co-payment assistance is accrued at the time of product sale to SPs based on estimated patient participation and average co-pay benefit to be paid per a claim. The Company’s estimated amounts are compared to actual program participation and co-pay amounts paid using data provided by third-party administrators. If actual amounts differ from the original estimates the assumptions being applied are updated and adjustment for prior period accruals will be adjusted in the current period.
Product Returns: Consistent with industry practice, the Company offers SPs and SDs limited product return rights for damages, shipment errors, and expiring product, provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company does not allow product returns for product that has been dispensed to a patient. As the Company receives inventory reports from the SPs and has the ability to control the amount of product that is sold to the SPs, it is able to make a reasonable estimate of future potential product returns based on this on-hand channel inventory data and sell-through data obtained from the SPs. Currently, sales to SDs are limited and there is no access to on-hand channel inventory or sell through data. As these arrangements mature, the Company will utilize any data that they can provide as part of this analysis. In arriving at its estimate, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry.
Research and Development Costs
11
12
Income Taxes
The Company accounts for income taxes in accordance with the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) 740, Income Taxes. 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 June 30, 2024, the Company had
As part of the Tax Cuts and Jobs Act of 2017 ("TCJA"), beginning with the Company’s fiscal year ended December 31, 2022, the Company is required to capitalize research and development expenses, as defined under section 174 of the Internal Revenue Code of 1986, as amended. For expenses that are incurred for research and development in the United States, the amounts will be amortized over
3. Net Loss per Share
Net Loss per Share Attributable to Common Stockholders
The following table sets forth the computation of basic and diluted net loss per share of common stock (in thousands, except share and per share data):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average shares used in computing net loss per share |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Basic and diluted weighted average shares of common stock outstanding for the three and six months ended June 30, 2024 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 $
The Company’s potentially dilutive securities, which include unexercised stock options outstanding, unexercised warrants and unvested restricted stock units, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect.
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
||||
Stock options to purchase common stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrants to purchase common stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unvested restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
||||
12
13
4. Investments
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.
A summary of the Company’s available-for-sale classified investments as of December 31, 2023 consisted of the following (in thousands):
|
|
At December 31, 2023 |
|
|||||||||||||
Investments - Current: |
|
Cost Basis |
|
|
Accumulated Unrealized Gains |
|
|
Accumulated Unrealized Losses |
|
|
Fair Value |
|
||||
United States Treasury securities |
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
|
|||
Commercial paper |
|
$ |
|
|
$ |
- |
|
|
$ |
( |
) |
|
|
|
||
Corporate bonds |
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
United States Government Agency securities |
|
|
|
|
|
- |
|
|
|
( |
) |
|
|
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
The Company did not have any investments as of June 30, 2024.
5. Inventory
The Company's inventory balance consists of the following (in thousands):
|
|
December 31, |
|
|
June 30, |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work-in-process |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
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. At December 31, 2023 and June 30, 2024, the Company has an allowance for excess, damaged and obsolete inventory in the amount of $
6. Property and Equipment
Purchased property and equipment consist of the following (dollars in thousands):
|
|
ESTIMATED |
|
December 31, |
|
|
June 30, |
|
||
Office equipment |
|
|
$ |
|
|
$ |
|
|||
Office furniture |
|
|
|
|
|
|
|
|||
Computer equipment |
|
|
|
|
|
|
|
|||
Leasehold improvements |
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
||
Less: Accumulated depreciation |
|
|
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
|
|
$ |
|
|
$ |
|
||
Depreciation expense for the three months ended June 30, 2023 and 2024 was $
Depreciation expense for the six months ended June 30, 2023 and 2024 was $
13
14
7. Accrued Expenses
Accrued expenses consist of the following (in thousands):
|
|
December 31, |
|
|
June 30, |
|
||
Employee compensation and related costs |
|
$ |
|
|
$ |
|
||
Sales allowances and related costs |
|
|
|
|
|
|
||
Manufacturing costs |
|
|
|
|
|
|
||
Contract research and development |
|
|
|
|
|
|
||
Consulting and professional service fees |
|
|
|
|
|
|
||
Royalty |
|
|
|
|
|
|
||
Financing costs |
|
|
— |
|
|
|
|
|
Inventory in transit |
|
|
|
|
|
— |
|
|
Other |
|
|
|
|
|
|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
||
8. Fair Value of Financial Instruments
FASB ASC Topic 820, 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 loan payable is considered a reasonable estimate of fair value because the Company’s interest rate is near current market rates for instruments with similar characteristics.
14
15
The following tables summarize the Company’s assets 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, 2023 |
|
|||||||||||||
|
|
TOTAL |
|
|
Quoted Prices |
|
|
Significant |
|
|
Significant |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Total cash equivalents |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
United States Treasury securities |
|
|
|
|
|
|
|
|
- |
|
|
|
— |
|
||
Commercial paper |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Corporate bonds |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
United States Government Agency securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Investments |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Derivative liability |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
As of June 30, 2024 |
|
|||||||||||||
|
|
TOTAL |
|
|
Quoted Prices |
|
|
Significant |
|
|
Significant |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Derivative liability |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Changes in the fair value of the Company's Level 3 derivative liability for the six months ended June 30, 2024 are as follows (in thousands):
At December 31, 2023 |
|
$ |
|
|
|
|
( |
) |
|
At June 30, 2024 |
|
$ |
|
9. Debt
The following table presents the carrying value of the Company's debt balance as of December 31, 2023 and June 30, 2024 (in thousands):
15
16
|
|
December 31, |
|
|
June 30, |
|
||
Face value |
|
$ |
|
|
$ |
|
||
Less: discount |
|
|
( |
) |
|
|
( |
) |
Total |
|
|
|
|
$ |
|
||
Less: current portion |
|
|
— |
|
|
|
— |
|
Long-term portion |
|
$ |
|
|
$ |
|
||
Oaktree Agreement
On October 13, 2022 (“Oaktree 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 $
The first tranche of $
The term loan initially bears interest at the three-month term Secured Overnight Financing Rate (“SOFR”) plus an applicable margin of
In connection with entering into the Oaktree Agreement, the Company granted warrants to Oaktree to purchase up to an aggregate of
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 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 June 30, 2024. 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 $
In connection with the issuance of the term loan, the Company recorded a debt discount of $
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 Oaktree 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
16
17
the Oaktree Agreement, respectively. For the six months ended June 30, 2023 and 2024, the Company recorded $
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 $
As of June 30, 2024, future principal payments due under the Oaktree Agreement were as follows (in thousands):
Year ended: |
|
|
|
|
December 31, 2024 |
|
$ |
— |
|
December 31, 2025 |
|
|
|
|
December 31, 2026 |
|
|
|
|
December 31, 2027 |
|
|
|
|
Total minimum principal payments |
|
|
|
|
Less unamortized discount |
|
|
( |
) |
Carrying value of term loan |
|
$ |
|
|
In conjunction with the closing of the Perceptive Financing (Note 13), the Company used a portion of the proceeds of the term loan to prepay all outstanding loans under the Oaktree Agreement, including the exit fee, on the Closing Date.
10. Stockholders’ Equity
2021 At-the-Market Issuance Sales Agreement
On March 23, 2021, the Company entered into an Open Market Sale Agreement (the “2021 ATM Agreement”) with Cowen and Company, LLC (“Cowen”) with respect to an at-the-market offering 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 $
2024 At-the-Market Issuance Sales Agreement
Pursuant to the 2024 ATM Agreement, the Company could offer and sell shares of its common stock (the “2024 ATM Shares”), having an aggregate offering price of up to $
11. Stock-Based Compensation
Stock Options
The Company’s 2017 Stock Option and Incentive Plan (the “2017 Stock Plan”) became effective in , upon the closing of the Company’s initial public offering and will expire in . Under the 2017 Stock Plan, the Company may grant incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units (“RSUs”) and other stock-based awards. The Company’s 2014 Stock Incentive Plan (the “2014 Stock Plan”) was terminated in effective upon the completion of the Company’s initial public offering and
As of June 30, 2024, there were
17
18
At June 30, 2024, there were
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
Awards granted under the 2017 Stock Plan and the Inducement Plan have a term of
The fair value of options at date of grant was estimated using the Black-Scholes option-pricing model with the following assumptions:
|
|
Six Months Ended |
|
|||||
|
|
2023 |
|
|
2024 |
|
||
Risk-free interest rate |
|
|
|
|
||||
Expected dividend yield |
|
|
|
|
||||
Expected life |
|
|
|
|
||||
Expected volatility |
|
|
|
|
||||
Weighted-average grant date fair value |
|
$ |
|
|
$ |
|
||
The following table summarizes information about stock option activity during the six months ended June 30, 2024 (in thousands, except share and per share data):
|
|
NUMBER OF |
|
|
WEIGHTED- |
|
|
WEIGHTED- |
|
|
AGGREGATE |
|
||||
Outstanding, December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding, June 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and exercisable, June 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Vested and expected to vest, June 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The following table summarizes information about RSU activity during the six months ended June 30, 2024:
|
|
RSUs |
|
|
AVERAGE GRANT |
|
||
RSUs outstanding, December 31, 2023 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Released |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
RSUs outstanding at June 30, 2024 |
|
|
|
|
$ |
|
||
Unrecognized compensation expense related to unvested options as of June 30, 2024 was $
18
19
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 the six months ended June 30, 2024,
The Company recorded stock-based compensation expense in the following expense categories of its accompanying condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 and 2024 (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
12. Commitments and Contingencies
Operating Leases
The Company leases office facilities and equipment under long-term, non-cancelable operating lease agreements. The leases expire at various dates through
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.
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
The following is a maturity analysis of the annual undiscounted cash flows of the operating lease liabilities as of June 30, 2024 (in thousands):
Year ended: |
|
|
|
|
December 31, 2024 |
|
$ |
|
|
December 31, 2025 |
|
|
|
|
December 31, 2026 |
|
|
|
|
December 31, 2027 |
|
|
|
|
December 31, 2028 |
|
|
|
|
Thereafter |
|
|
|
|
Total minimum lease payments |
|
|
|
|
Less imputed interest |
|
|
( |
) |
Total |
|
$ |
|
|
|
|
Six Months Ended |
|
|||||
|
|
2023 |
|
|
2024 |
|
||
Lease cost: |
|
|
|
|
|
|
||
Operating lease cost |
|
$ |
|
|
$ |
|
||
Short-term lease cost |
|
|
|
|
|
|
||
Total lease cost |
|
$ |
|
|
$ |
|
||
Other information |
|
|
|
|
|
|
||
Cash paid for amounts included in the measurement of lease liabilities |
|
$ |
|
|
$ |
|
||
Operating cash flows from operating leases |
|
$ |
( |
) |
|
$ |
|
|
Weighted-average remaining lease term - operating leases |
|
|
|
|
||||
Weighted-average discount rate - operating leases |
|
|
% |
|
|
% |
||
19
20
Research and Development Agreements
As part of the Company’s research and development efforts, the Company enters into research and development agreements with certain 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.
13. 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 July 2024, the Company was notified that inventory was damaged during transport to a contract manufacturing organization. As a result, this inventory is unsaleable. The approximate value of the damaged inventory is $
Perceptive Financing
On August 9, 2024 (the “Closing Date”), the Company entered into the Credit Agreement and Revenue Purchase and Sale Agreement. The Credit Agreement establishes a $
Borrowings under the Term Loan will bear interest at a rate per annum equal to one-month term SOFR (subject to a
On the Closing Date, the Company also entered into the Revenue Purchase and Sale Agreement with the Purchaser. Under the Revenue Purchase and Sale Agreement, in exchange for the Purchaser's payment to the Company of a purchase price of $
FDA Approval of Supplemental Drug Application Expanding the FUROSCIX Indication to Include NYHA Class IV Chronic Heart Failure
On August 12, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application to expand FUROSCIX® for the treatment of congestion due to fluid overload in adults with New York Heart Association Class IV chronic heart failure.
2024 Public Offering
On August 12, 2024, the Company entered into the Underwriting Agreement with the Underwriters, relating to an underwritten offering of
The offering price of the Shares to the public is $
20
21
also granted the Underwriters an option exercisable for
The net proceeds from the Offering are expected to be approximately $
21
22
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q (“Quarterly Report”) and our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 (the “Annual Report”) filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many important factors, including those factors set forth in the “Risk Factors” section in our Annual Report and in this Quarterly Report, our actual results could 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, or West’s, on-body infusor, which delivers an 80 mg/10 mL dose over 5 hours. 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. The commercial launch of FUROSCIX for congestion in patients with chronic heart failure commenced in the first quarter of 2023.
In the third quarter of 2023, we received positive feedback from the FDA on key long-term growth initiatives. The first was for the potential expansion of the FUROSCIX indication to include NYHA Class IV heart failure patients. Based on the feedback, we filed for NYHA Class IV indication expansion in October 2023 with a PDUFA date set for August 10, 2024. The Company received approval of its supplemental drug application expanding the FUROSCIX indication in heart failure on August 9, 2024.
We are in the process of developing an 80mg/1mL autoinjector intended to provide an additional option to the on-body infusor for treatment of congestion due to fluid overload in eligible adult patients who do not require hospitalization. We believe that the development of an autoinjector, if successfully developed and approved, has the potential to significantly reduce manufacturing costs compared to the current on-body infusor and confer certain environmental advantages. We submitted an investigational new drug application (IND) in February 2024, initiated a pharmacokinetic/pharmacodynamic (PK/PD) study in April of 2024, and completed enrollment in May 2024 with data received in August 2024. We are targeting to submit a supplemental new drug application (sNDA) for the autoinjector by the end of 2024.
In early May of 2024 we submitted an sNDA seeking to expand the indication of FUROSCIX to include the treatment of edema due to fluid overload in adult patients with chronic kidney disease (CKD).The agency had previously confirmed that no additional clinical studies would be needed to expand the indication to CKD, provided that we can demonstrate an adequate PK/PD bridge to the listed drug, furosemide injection, 10mg/mL. The application was accepted for filing by the FDA in July 2024. The anticipated Prescription Drug User Fee Act (PDUFA) goal date for our sNDA seeking label expansion in patients with CKD is March 6, 2025.
We estimate that there is a $12.5 billion total addressable market opportunity for FUROSCIX in the United States including both chronic heart failure and CKD. We believe FUROSCIX will allow eligible patients with chronic heart failure and, if approved, chronic kidney disease with worsening symptoms due to fluid overload despite oral diuretics, to receive IV-strength diuresis outside the high-cost hospital setting. At a price of approximately $898 per dose, we estimate the average cost of treatment with FUROSCIX for each episode to be approximately $4,490, which can be significantly lower than the cost of a single hospitalization for worsening heart failure. Prevention of heart failure hospital admissions and reduced readmission rates would result in reducing days patients spend in the hospital each year. By decreasing the number of heart failure admissions and readmissions to hospitals, we believe we can drive significant cost savings to payers and hospitals and improve patients’ quality of life through outpatient management of their fluid overload.
We have secured positive coverage and a preferred formulary decision for FUROSCIX by a top five national commercial health plan, effective June 1, 2023, as well as national Medicaid coverage of FUROSCIX, effective July 1, 2023. In addition, in late October 2023, we reached an agreement with one of the largest closed integrated delivery networks (IDNs) in the United States, providing unrestricted access to FUROSCIX, without prior authorization, to over 8 million lives, at a fixed co-pay of $75 or less per
22
23
prescription. As of November 1, 2023, FUROSCIX is on formulary as a preferred brand with one of the largest government retiree payer formularies, increasing the number of lives with preferred access to FUROSCIX by an additional 1.1 million lives. As of June 30, 2024, there have been approximately 2,700 unique prescribers of FUROSCIX. In the quarter ended June 30, 2024 approximately 9,300 FUROSCIX doses were filled.
In June 2024, another U.S. patent was granted, further strengthening our coverage of concentrated formulations of furosemide. We have progressed our development on multiple formulations described in the patent properties, have identified potential product candidates, and commenced a clinical study with our lead formulation.
Perceptive Financing
On August 9, 2024 (the "Closing Date"), we entered into a Credit Agreement and Guaranty (the "Credit Agreement"), by and among us, the guarantors from time to time party thereto, the lenders from time to time party thereto (the "Lenders"), and Perceptive Credit Holdings IV, LP, in its capacity as administrative agent for the Lenders (in such capacity, the "Agent"). The Credit Agreement establishes a $75.0 million term loan facility, consisting of (i) $50.0 million (the “Tranche A Loan”) funded on the Closing Date, (ii) $25.0 million (the “Tranche B Loan” and, together with the Tranche A Loan, collectively, the “Term Loan”) that the we may borrow in a single borrowing on or prior to March 31, 2026; provided, in the case of the Tranche B Loan, that we and our subsidiaries have obtained certain regulatory approval and achieved certain net sales targets, each as described in the Credit Agreement. The Term Loan has a maturity date of August 9, 2029 (the “Maturity Date”). We will use the proceeds of the Term Loan to (x) on the Closing Date, prepay all outstanding loans under its existing credit facility with Oaktree Fund Administration, LLC, (y) support our commercialization efforts for FUROSCIX and (c) other working capital and general corporate purposes, including the payment of fees and expenses associated with the Credit Agreement.
Borrowings under the Term Loan will bear interest at a rate per annum equal to one-month term SOFR (subject to a 3.25% floor), plus an applicable margin of 6.75%, payable monthly in arrears. There will be no scheduled repayments of outstanding principal on the Term Loan prior to the Maturity Date. We may voluntarily prepay the outstanding Term Loan, subject to a yield protection premium equal to (i) 5.0% of the principal amount of the Term Loan prepaid, if prepaid on or prior to the first anniversary of the Closing Date, (ii) 3.0% of the principal amount of the Term Loan if prepaid after the first anniversary of the Closing Date through and including the second anniversary of the Closing Date, (iii) 1.0% of the principal amount of the Term Loan if prepaid after the second anniversary of the Closing Date through and including the third anniversary of the Closing Date, with no prepayment premium due after the third anniversary of the Closing date through the Maturity Date. On the Closing Date, we are required to issue to the Lenders of such Term Loan warrants to purchase 300,000 of shares of our common stock, in the aggregate (the “Warrant”), at an exercise price of $4.5902. The Warrant is immediately exercisable, and the exercise period will expire 6 years from the date of issuance.
Our obligations under the Credit Agreement and the other Loan Documents (as defined in the Credit Agreement) will be guaranteed by any domestic subsidiaries of ours that become Guarantors (as defined in the Credit Agreement), subject to certain exceptions. The Borrowers’ and the Guarantors’ (collectively, the “Loan Parties”) respective obligations under the Credit Agreement and the other Loan Documents are secured by first priority security interests in substantially all assets of the Loan Parties, subject to certain customary thresholds and exceptions. As of the Closing Date, there are no Guarantors.
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 the Agent of at least $5.0 million at all times after the Closing Date and (ii) meet minimum quarterly net sales targets described in the Credit Agreement.
In addition, the Credit Agreement contains customary events of default that entitle the Agent to cause our indebtedness under the Credit Agreement to become immediately due and payable, and to exercise remedies against the Loan Parties and the collateral securing the Term Loan, including cash. Under the Credit Agreement, an event of default will occur if, among other things, the 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 their 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. Upon the occurrence and for the duration of an event of default, an additional default interest rate equal to 3.0% per annum may apply to all obligations owed under the Credit Agreement.
On the Closing Date, we entered into a revenue participation right purchase and sale agreement (the "Revenue Purchase and Sale Agreement") with Perceptive Credit Holdings IV, LP (the "Purchaser"). Under the terms of the Revenue Purchase and Sale Agreement, in exchange for the Purchaser’s payment to the us of a purchase price of $50.0 million, in the aggregate subject to
23
24
certain conditions at closing (the “Purchase Price”), we have agreed to sell to the Purchaser its right to receive payment in full of a tiered single digit percentage of net sales of FUROSCIX (the “Revenue Payment”) for each calendar quarter commencing on the effective date of the Revenue Purchase and Sale Agreement, subject to adjustments on June 30, 2028 and June 30, 2030 depending on the amount of Revenue Payments received by such dates. The Purchaser’s right to receive the Revenue Payment terminates and we no longer have the obligation to pay Purchaser Revenue Payments once the Purchaser receives 200.0% (subject to reductions on September 30, 2027 and September 30, 2029 depending on the amount of Revenue Payments received by such dates) of the Purchase Price. We may also buy-out the Purchaser’s rights to receive the Revenue Payments by paying Purchaser a tiered multiple on the Purchaser Price.
The Agreement contains various representations and warranties, including with respect to organization, authorization, and certain other matters, certain covenants with respect to payment, reporting, intellectual property, in-licenses, out-licenses, and certain other actions, indemnification obligations and other provisions customary for transactions of this nature.
2024 Public Offering
On August 12, 2024, we entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC and TD Securities (USA) LLC, as representatives of the several underwriters named in Schedule A thereto (collectively, the “Underwriters”), relating to an underwritten offering of 12,000,000 shares (the “Shares”) of our common stock, $0.0001 par value per share (the “Common Stock”), and, in lieu of Common Stock to select investors, pre-funded warrants (the “Pre-funded Warrants”) to purchase 500,000 shares of Common Stock (the “Offering”).
The offering price of the Shares to the public is $4.00 per share, and the offering price of the Pre-funded Warrants to the public is $3.999 per underlying share, which is equal to the price per share of Common Stock being sold in this offering, minus $0.001, which is the exercise price per share of the Pre-funded Warrants. Under the terms of the Underwriting Agreement, we also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 1,875,000 shares of Common Stock at a price of $4.00 per share, less underwriting discounts and commissions. On August 12, 2024, the Underwriters exercised this option in full. The closing of the Offering (including the sale of the Shares subject to the Underwriters’ option to purchase additional shares) took place on August 13, 2024.
The net proceeds from the Offering are expected to be approximately $53.5 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We do not intend to list the Pre-funded Warrants on Nasdaq or any other nationally recognized securities exchange or trading system.
We have funded our operations from inception through June 30, 2024 primarily through the sale of shares of our common stock and incurrence of debt and, prior to that, through the private placement of our preferred stock.
As of June 30, 2024, we had an accumulated deficit of $312.5 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 expanding 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.
As of June 30, 2024, we had an accumulated deficit of approximately $312.5 million and cash and cash equivalents of $38.5 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
Product Revenues
Product revenues, net, consist of net sales of FUROSCIX. We initiated shipments of FUROSCIX to customers in the United States, which include specialty pharmacies, in February 2023. We recognize revenue for product received by our customers net of allowances for customer discounts, service fees, estimated returns and rebates.
Cost of Product Revenues
Cost of product revenues include costs related to the manufacturing of FUROSCIX, including third party manufacturing costs, packaging and freight, in addition to royalty expenses. We began capitalizing inventory upon FDA approval of FUROSCIX. All
24
25
costs related to inventory for FUROSCIX prior to FDA approval were expensed as incurred and therefore not included in cost of revenues.
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:
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:
Selling, General and Administrative Expenses
Selling, general and administrative ("SG&A") expenses consist of employee-related expenses, including salaries, benefits, travel expense and stock-based compensation expense for personnel in executive, finance, commercial, field sales, human resources, facility operations and administrative functions. Other SG&A expenses include 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.
We anticipate that our SG&A expenses will increase as we continue to expand our corporate and commercial infrastructure to support the commercialization activities of FUROSCIX in the United States.
Results of Operations
Comparison of Three Months Ended June 30, 2023 and 2024
25
26
The following table summarizes our results of operations for the three months ended June 30, 2023 and 2024 (in thousands):
|
|
Three Months Ended June 30, |
|
|
Increase |
|
||||||
|
|
2023 |
|
|
2024 |
|
|
(Decrease) |
|
|||
Product revenues, net |
|
$ |
1,638 |
|
|
$ |
8,054 |
|
|
$ |
6,416 |
|
|
|
|
|
|
|
|
|
|
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Cost of product revenues |
|
|
354 |
|
|
|
2,300 |
|
|
|
1,946 |
|
Research and development |
|
|
2,934 |
|
|
|
2,677 |
|
|
|
(257 |
) |
Selling, general and administrative |
|
|
12,096 |
|
|
|
17,508 |
|
|
|
5,412 |
|
Total operating expenses |
|
|
15,384 |
|
|
|
22,485 |
|
|
|
7,101 |
|
|
|
|
|
|
|
|
|
|
|
|||
Loss from operations |
|
|
(13,746 |
) |
|
|
(14,431 |
) |
|
|
685 |
|
Other income (loss) |
|
|
239 |
|
|
|
(1,189 |
) |
|
|
(1,428 |
) |
Interest income |
|
|
1,363 |
|
|
|
664 |
|
|
|
(699 |
) |
Interest expense |
|
|
(2,010 |
) |
|
|
(2,134 |
) |
|
|
124 |
|
Net loss |
|
$ |
(14,154 |
) |
|
$ |
(17,090 |
) |
|
$ |
2,936 |
|
Product revenues. Product revenues were $8.1 million for the three months ended June 30, 2024, compared to $1.6 million for the three months ended June 30, 2023. The increase of $6.4 million was due to an increase in demand of FUROSCIX further into commercial launch.
Cost of product revenues. Cost of product revenues were $2.3 million for the three months ended June 30, 2024, compared to $0.4 million for the three months ended June 30, 2023. Similar to product revenues, the increase of $1.9 million was due to an increase in demand of FUROSCIX further into commercial launch, and related manufacturing costs.
Research and development expenses. R&D expenses were $2.7 million for the three months ended June 30, 2024, compared to $2.9 million for the three months ended June 30, 2023. The decrease of $0.3 million was primarily attributable to a $0.9 million decrease in pharmaceutical development costs. The decrease was partially offset by a $0.5 million increase in clinical study costs, and a $0.1 million increase in employee-related costs.
Selling, general and administrative expenses. SG&A expenses were $17.5 million for the three months ended June 30, 2024, compared to $12.1 million for the three months ended June 30, 2023. The increase of $5.4 million was primarily attributable to a $2.4 million increase in employee-related costs, a $1.4 million increase in commercial costs, a $1.4 million increase in product samples, a $0.3 million increase in patient support, and a $0.1 million increase in legal costs. The increase was partially offset by a $0.1 million decrease in professional service costs and $0.1 million decrease in taxes and insurance.
Other income (loss). Other loss was $1.2 million for the three months ended June 30, 2024, compared to other income of $0.2 million for the three months ended June 30, 2023. The increase in loss of $1.4 million was primarily attributable to the fair value adjustment to the derivative liability and foreign exchange losses in the three months ended June 30, 2024.
Interest income. Interest income was $0.7 million for the three months ended June 30, 2024, compared to $1.4 million for the three months ended June 30, 2023. The decrease of $0.7 million was primarily attributable to lower balances on our financial instruments.
Interest expense. Interest expense was $2.1 million for the three months ended June 30, 2024 compared to $2.0 million for the three months ended June 30, 2023. The increase of $0.1 million was due to amortization of costs associated with the Oaktree Agreement (as defined below).
Comparison of Six Months Ended June 30, 2023 and 2024
26
27
The following table summarizes our results of operations for the six months ended June 30, 2023 and 2024 (in thousands):
|
|
Six Months Ended June 30, |
|
|
Increase |
|
||||||
|
|
2023 |
|
|
2024 |
|
|
(Decrease) |
|
|||
Product revenues, net |
|
$ |
3,701 |
|
|
$ |
14,156 |
|
|
$ |
10,455 |
|
|
|
|
|
|
|
|
|
|
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Cost of product revenues |
|
|
959 |
|
|
|
4,085 |
|
|
|
3,126 |
|
Research and development |
|
|
5,050 |
|
|
|
5,403 |
|
|
|
353 |
|
Selling, general and administrative |
|
|
22,992 |
|
|
|
34,955 |
|
|
|
11,963 |
|
Total operating expenses |
|
|
29,001 |
|
|
|
44,443 |
|
|
|
15,442 |
|
|
|
|
|
|
|
|
|
|
|
|||
Loss from operations |
|
|
(25,300 |
) |
|
|
(30,287 |
) |
|
|
4,987 |
|
Other income |
|
|
1,229 |
|
|
|
1,783 |
|
|
|
554 |
|
Interest income |
|
|
2,678 |
|
|
|
1,541 |
|
|
|
(1,137 |
) |
Interest expense |
|
|
(3,971 |
) |
|
|
(4,235 |
) |
|
|
264 |
|
Net loss |
|
$ |
(25,364 |
) |
|
$ |
(31,198 |
) |
|
$ |
5,834 |
|
Product revenues. Product revenues were $14.2 million for the six months ended June 30, 2024, compared to $3.7 million for the six months ended June 30, 2023. The increase of $10.5 million was due to an increase in demand of FUROSCIX further into commercial launch.
Cost of product revenues. Cost of product revenues were $4.1 million for the six months ended June 30, 2024, compared to $1.0 million for the six months ended June 30, 2023. Similar to product revenues, the increase of $3.1 million was due to an increase in demand of FUROSCIX further into commercial launch, and related manufacturing costs.
Research and development expenses. R&D expenses were $5.4 million for the six months ended June 30, 2024, compared to $5.1 million for the six months ended June 30, 2023. The increase of $0.4 million was primarily attributable to a $0.6 million increase in clinical study costs, a $0.5 million increase in device development costs, a $0.2 million increase in patent costs, and a $0.1 million increase in employee-related costs. The increase was partially offset by a $0.9 million decrease in pharmaceutical development costs, and a $0.1 million decrease in consulting and professional services costs.
Selling, general and administrative expenses. SG&A expenses were $35.0 million for the six months ended June 30, 2024, compared to $23.0 million for the six months ended June 30, 2023. The increase of $12.0 million was primarily attributable to a $6.3 million increase in employee-related costs, a $3.0 million increase in commercial costs, a $2.3 million increase in product samples, and a $0.7 million increase in patient support. The increase was partially offset by a $0.2 million decrease in taxes and insurance and $0.1 million decrease in professional service costs.
Other income. Other income was $1.8 million for the six months ended June 30, 2024, compared to $1.2 million for the six months ended June 30, 2023. The increase in income of $0.6 million was primarily attributable to the fair value adjustment to the derivative liability in the six months ended June 30, 2024, offset by expired financing costs.
Interest income. Interest income was $1.5 million for the six months ended June 30, 2024, compared to $2.7 million for the six months ended June 30, 2023. The decrease of $1.1 million was primarily attributable to lower balances on our financial instruments.
Interest expense. Interest expense was $4.2 million for the six months ended June 30, 2024 compared to $4.0 million for the six months ended June 30, 2023. The increase of $0.3 million was due to amortization of costs associated with the Oaktree Agreement (as defined below).
LIQUIDITY AND CAPITAL RESOURCES
Overview
We have funded our operations from inception through June 30, 2024 primarily through the sale of shares of our common stock, through the private placement of our preferred stock and the incurrence of debt. As of June 30, 2024, 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 previous term loan under the Credit Agreement and Guaranty (the “Oaktree Agreement”) with Oaktree Fund Administration, LLC as administrative agent, and
27
28
the lenders party thereto (collectively “Oaktree”) to borrow up to $100.0 million in three tranches; $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 $15.2 million from the sale of common stock in our 2021 at-the-market offering. As of June 30, 2024, we had cash and cash equivalents of $38.5 million. Our cash and cash equivalents are maintained at a number of financial institutions in amounts that may exceed federally insured limits. Our existing cash and cash equivalents, including the available proceeds from the Credit Agreement, the Revenue Purchase and Sale Agreement, and the underwritten offering, each as described below, will be sufficient to meet its cash commitments for at least the next 12 months after the date that the interim condensed consolidated financial statements are issued.
On March 23, 2021, we entered into an Open Market Sales 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. On March 13, 2024, we amended the 2021 ATM Agreement by issuing a the 2024 ATM Agreement. As of March 13, 2024, we had sold a total of 1,726,043 2021 ATM Shares under the 2021 ATM Program at a weighted average gross selling price of $9.01 per share for net proceeds of $15.2 million.
On March 13, 2024, we amended and restated the 2021 ATM Agreement where we entered into an Open Market Sales Agreement with Cowen with respect to an at-the-market offering program under which we could offer and sell the 2024 ATM Shares, having an aggregate offering price of up to $50.0 million through Cowen as its sales agent (the "2024 ATM Program"). The offering and sale of the 2024 ATM Shares will be made pursuant to the our shelf registration statement of Form S-3, which was declared effective by the SEC on March 22, 2024. There were no shares issued under the 2024 ATM Program as of June 30, 2024. Please see Note 10. Stockholders’ Equity to our condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
On October 13, 2022, we entered into the Oaktree Agreement which established a $100.0 million term loan facility. Our contractual commitments under the Oaktree Agreement as of June 30, 2024 consisted of an aggregate of $68.4 million in repayment obligations, inclusive of related interest amounts and final fee in the amount of $1.0 million. Please see Note 9. Debt to our condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
On August 9, 2024, we entered into the Credit Agreement and Revenue Purchase and Sale Agreement. The Credit Agreement establishes a $75.0 million term loan facility, consisting of (i) $50.0 million funded immediately and (ii) $25.0 million that we may borrow in a single borrowing on or prior to March 31, 2026. Under the Revenue Purchase and Sale Agreement, in exchange for the Purchaser's payment to us of a purchase price of $50.0 million, in the aggregate, we have agreed to sell to the Purchaser its right to receive payment in full of a tiered single digit percentage of net sales of FUROSCIX. In conjunction with the closing of the Credit Agreement financing, we used a portion of the proceeds of the term loan to prepay all outstanding loans under the Oaktree Agreement.
On August 12, 2024, we entered into the Underwriting Agreement with the Underwriters, relating to an underwritten offering of 12,000,000 shares of our common stock, $0.0001 par value per share, and, in lieu of Common Stock to select investors, pre-funded warrants to purchase 500,000 shares of Common Stock. The net proceeds from the Offering are expected to be approximately $53.5 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.
We expect to incur substantial additional expenditures in the near future to support our ongoing activities and commercialization of FUROSCIX. We expect our costs and expenses to increase in the future as we continue U.S. commercialization of FUROSCIX, including the expansion of our 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. Additionally, we continue to incur additional costs as a result of operating as a public company. We plan to continue to fund our operations through cash and cash equivalents on hand. Additionally, we expect to have access to funds pursuant to our at-the-market offering program with Cowen and Company, LLC, or we could otherwise seek additional funding through a combination of public or private equity offerings if we believe additional resources are needed. Our future capital requirements will depend on many factors, including without limitation:
28
29
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 and developments in our industry. 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 and/or instability, including due to war or terrorism, supply chain issues and rising inflation and interest rates.
CASH FLOWS
The following table summarizes our sources and uses of cash for each of the periods presented:
|
|
Six Months Ended |
|
|||||
(in thousands) |
|
2023 |
|
|
2024 |
|
||
Net cash (used in) provided by: |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(30,635 |
) |
|
$ |
(37,928 |
) |
Investing activities |
|
|
16,427 |
|
|
|
29,320 |
|
Financing activities |
|
|
14,315 |
|
|
|
298 |
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
107 |
|
|
$ |
(8,310 |
) |
Net Cash Used in Operating Activities
During the six months ended June 30, 2024, net cash used in operating activities was $37.9 million, consisting primarily of a net loss of $31.2 million and an increase in net operating assets of $8.9 million. This was offset by non-cash charges of $2.2 million. The increase in net operating assets is related to accounts receivable and inventory to support the ongoing commercial operations of FUROSCIX. The non-cash charges primarily consisted of depreciation, amortization related to our right-of-use leased assets, stock-based compensation expense, non-cash interest expense related to amortization of debt discount associated with the Oaktree Agreement, the fair value adjustment to the derivative liability and accretion of premium on investments.
During the six months ended June 30, 2023, net cash used in operating activities was $30.6 million, consisting primarily of a net loss of $25.4 million and an increase in net operating assets of $6.5 million. This was offset by non-cash charges of $1.3 million. The increase in net operating assets is related to accounts receivable and inventory to support the launch of FUROSCIX. The non-cash charges primarily consisted of depreciation, amortization related to our right-of-use leased assets, stock-based
29
30
compensation expense, non-cash interest expense related to amortization of debt discount associated with the Oaktree Agreement, the fair value adjustment to the derivative liability and accretion of premium on investments.
Net Cash Provided by Investing Activities
During the six months ended June 30, 2024, net cash provided by investing activities was $29.3 million, consisting of maturities of short-term investments.
During the six months ended June 30, 2023, net cash provided by investing activities was $16.4 million, consisting primarily of maturities of short-term investments, net of purchases.
Net Cash Provided by Financing Activities
During the six months ended June 30, 2024, net cash provided by financing activities was $0.3 million due to purchases pursuant to our 2017 Employee Stock Purchase Plan and stock option exercises, offset by amounts paid to settle restricted stock unit tax withholding obligations.
During the six months ended June 30, 2023, net cash provided by financing activities was $14.3 million, consisting of proceeds from the 2021 ATM Agreement, purchases pursuant to our 2017 Employee Stock Purchase Plan and stock option exercises.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these 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. Our critical accounting policies are more fully described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates” in our Annual Report. There have been no material changes to that information disclosed in our Annual Report during the six months ended June 30, 2024.
Item 3. 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 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 June 30, 2024, 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 cap on SOFR in our outstanding indebtedness and the current SOFR rate, 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.
Item 4. 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.
30
31
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report, 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 June 30, 2024, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of such date were not effective at a reasonable assurance level due to the continued material weakness in our internal control over financial reporting as described below and in Item 9A, Controls and Procedures, in our Annual Report which was filed on March 13, 2024.
In light of the identified material weakness, we performed additional analysis and other procedures around the review of the calculation performed by our third-party valuation specialist.
Previously Reported Material Weakness in Internal Control over Financial Reporting
As previously disclosed in Item 9A, Controls and Procedures, on Form 10-K filed March 13, 2024, as of and for the year ended December 31, 2023, we identified a deficiency resulting in a material weakness further described below.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. In connection with the preparation of our financial statements our Annual Report on Form 10-K, management identified a material weakness related to the controls, processes and procedures over the fair value accounting associated with the embedded derivative liability in connection with the Oaktree Agreement. Please see Note 9, Debt, to our condensed consolidated financial statements included elsewhere in this Quarterly Report for a description of the Oaktree Agreement. Specifically, the calculation performed by our third-party valuation specialist during the fourth quarter of fiscal 2023 as it relates to fair value accounting for the liability included errors resulting in an overstatement in the fair value of the liability. We made adjustments necessary to properly reflect the fair value of the derivative liability in the financial statements included in our Annual Report. There were no changes to previously released financial results as a result of this material weakness.
Remediation Plan
Management is actively working to remediate the identified material weakness and is committed to remediating the material weakness in a timely manner. Our remediation process is ongoing and includes the following steps, but is not limited to the following:
(a) additional quality control processes implemented by our third-party valuation specialist,
(b) detailed discussions around changes in assumptions used in the valuation and their effect on the valuation, and
(c) more thorough review of sample iterations used in determining the fair value of the derivative.
While the audit committee of our board of directors and senior management are closely monitoring the remediation efforts, until the remediation efforts discussed in this section, including any additional remediation efforts that our senior management identifies as necessary, are complete, tested and determined effective, we will not be able to conclude that the material weakness has been remediated. The material weakness will not be considered remediated until the controls are in place for a period of time and management concludes based on its evaluation that these controls are properly designed and operating effectively.
Changes in Internal Control over Financial Reporting
Other than the material weakness described above, 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 June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
31
32
PART II — OTHER INFORMATION
Item 1. 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.
Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. Information regarding risk factors appears in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023 (the "Annual Report"), which was filed with the SEC on March 22, 2024. There have been no material changes from the risk factors previously disclosed in our Annual Report.
Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
None.
During the three months ended June 30, 2024, no director or officer of the Company
Item 6. Exhibits
32
33
EXHIBIT INDEX
Exhibit Number |
|
Description |
|
|
|
3.1 |
|
|
|
|
|
3.2 |
|
|
|
|
|
3.3 |
|
|
|
|
|
3.4 |
|
|
|
|
|
4.2 |
|
|
|
|
|
4.3 |
|
|
|
|
|
4.4 |
|
|
|
|
|
4.5 |
|
|
|
|
|
10.1 |
|
|
|
|
|
10.2 |
|
|
|
|
|
31.1* |
|
|
|
|
|
31.2* |
|
|
|
|
|
32.1** |
|
|
|
|
|
32.2** |
|
|
|
|
|
101* |
|
Inline XBRL Document Set for the condensed consolidated financial statements and accompanying notes in Part I, Item 1, “Financial Statements” of this Quarterly Report on Form 10-Q. |
|
|
|
104* |
|
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101*). |
* Filed herewith.
** Furnished herewith.
33
34
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
SCPHARMACEUTICALS INC. |
||
|
|
|
|
|
Date: August 14, 2024 |
|
By: |
|
/s/ Rachael Nokes |
|
|
|
|
Rachael Nokes |
|
|
|
|
Chief Financial Officer (Principal Financial Officer) |
34
Exhibit 31.1
CERTIFICATION
I, John H. Tucker, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q for the period ended June 30, 2024 of scPharmaceuticals Inc.;
2. 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;
3. 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;
4. The registrant's other certifying officer 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. 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;
b. 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;
c. 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
d. 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 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. 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
b. 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: August 14, 2024 |
|
|
/s/ John H. Tucker |
|
|
|
John H. Tucker |
|
|
|
President and Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION
I, Rachael Nokes, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q for the period ended June 30, 2024 of scPharmaceuticals Inc.;
2. 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;
3. 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;
4. The registrant's other certifying officer 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. 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;
b. 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;
c. 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
d. 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 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. 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
b. 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: August 14, 2024 |
|
|
/s/ Rachael Nokes |
|
|
|
Rachael Nokes |
|
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Chief Financial Officer |
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(Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of scPharmaceuticals Inc. (the “Company”) for the period ended June 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, John H. Tucker, President and Chief Executive Officer (Principal Executive Officer), hereby 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) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 14, 2024 |
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/s/ John H. Tucker |
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John H. Tucker |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of scPharmaceuticals Inc. (the “Company”) for the period ended June 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Rachael Nokes, Chief Financial Officer (Principal Financial Officer), hereby 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) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 14, 2024 |
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/s/ Rachael Nokes |
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Rachael Nokes |
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Chief Financial Officer |
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(Principal Financial Officer) |