Funds to be used to facilitate U.S. commercial launch of FUROSCIX®
BURLINGTON, Mass., Oct. 10, 2022 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), 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, today announced that the company has entered into a binding term sheet with respect to a $100 million secured debt facility with funds managed by Oaktree Capital Management, L.P. (“Oaktree”). The potential transaction is subject to the parties’ execution of definitive agreements and customary closing conditions to be stipulated therein. The definitive agreements are expected to be signed by mid-October. Cowen acted as exclusive financial advisor to scPharmaceuticals on this transaction.
scPharmaceuticals plans to use these available funds, together with cash on-hand, to repay indebtedness under its existing loan and security agreement and to execute on the launch of FUROSCIX, which received marketing approval from the U.S. Food and Drug Administration (FDA) on October 7, 2022.
Per the terms of the binding term sheet, Oaktree is expected to provide scPharmaceuticals with $50 million immediately upon signing of the definitive agreements. The remaining $50 million would be made available in two additional $25 million tranches based upon the achievement of pre-specified commercial milestones. The debt facility is expected to carry an interest rate equal to the three month secured overnight financing rate (SOFR) plus 8.75%, with the interest rate capped at 11.75% per annum. Following the achievement of $100 million in trailing twelve-month U.S. net sales of FUROSCIX, the interest rate margin will be lowered to 8.25%. The debt facility is expected to mature five years from funding and carry a 36 month interest-only period.
“With FUROSCIX now approved for marketing in the U.S., we have transitioned to a commercial stage company and combined with our current cash balances, this flexible financing provided by Oaktree will provide us with the resources to help drive a very robust commercial launch in the near term,” stated John Tucker, chief executive officer of scPharmaceuticals. “We firmly believe that FUROSCIX will fundamentally change the treatment paradigm for worsening heart failure due to congestion by significantly reducing the complications and costs associated with hospital admissions, a significant percentage of which are unnecessary. We will work tirelessly to make FUROSCIX available to patients who can benefit from it as expeditiously as possible.”
“We are pleased to be partnering with scPharmaceuticals during this transformatory period marked by the recent approval and upcoming launch of FUROSCIX,” said Steve DeNelsky, Managing Director, Life Sciences Lending at Oaktree. “After a lack of innovation for several decades in the management of congestion due to fluid overload in heart failure patients, FUROSCIX represents an innovative breakthrough that now enables subcutaneous delivery of furosemide outside the hospital. Through this extension of capital, Oaktree looks forward to supporting the Company’s leadership team in making this novel therapy available to adult patients across the United States.”
scPharmaceuticals reported $56.0 million of cash, cash equivalents, restricted cash and investments on June 30, 2022.
FUROSCIX® (furosemide injection) 80 mg/10 mL for subcutaneous use
INDICATIONS AND LIMITATIONS OF USE
FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use is a loop diuretic indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.
FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema. FUROSCIX Infusor will deliver only an 80-mg dose.
IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide or medical adhesives and in patients with hepatic cirrhosis or ascites.
Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.
Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.
In patients with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital.
Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued.
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.
In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.
Please see FUROSCIX full prescribing information at FUROSCIX.com/prescribing-information.pdf and Instructions for Use at FUROSCIX.com/instructions-for-use.pdf.
About scPharmaceuticals
scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.
About Oaktree
Oaktree is a leader among global investment managers specializing in alternative investments, with $159 billion in assets under management as of June 30, 2022. The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to investments in credit, private equity, real assets and listed equities. The firm has over 1,000 employees and offices in 20 cities worldwide. For additional information, please visit Oaktree’s website at www.oaktreecapital.com.
Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the availability, timing and terms of the anticipated new debt facility, the significance and potential impact of the results of clinical trials and clinical data; the interpretation and analyses of the results from clinical trials; expectations regarding the potential market impact of FUROSCIX; the preparation and timing of commercial launch and the success of such commercialization; and the potential benefits, expected costs and future plans and expectations for FUROSCIX. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that definitive agreements for the new debt facility are not entered into on the expected timing or anticipated terms or at all, or results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the risk of the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the receipt of regulatory approval for any of our product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, risks related to manufacturing and quality assurances processes, and the risk that the current COVID-19 pandemic will impact the Company’s device validation, drug stability testing, and other operations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Company’s Annual Report on Form 10-K for the year ended December 31, 2021 on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
Katherine Taudvin
scPharmaceuticals Inc., 781-301-6706
ktaudvin@scpharma.com
Investors:
Hans Vitzthum
LifeSci Advisors, 617-430-7578
hans@lifesciadvisors.com
