|View printer-friendly version|
Announced FDA marketing approval of FUROSCIX® (furosemide injection), the first and only self-administered, subcutaneous loop diuretic for the at-home treatment of congestion in chronic heart failure
Entered into a secured debt financing agreement for up to
Continued to advance commercial readiness activities in support of upcoming FUROSCIX commercial launch planned in Q1 2023
Company to host inaugural investor call and webcast today,
October 2022, announced U.S. Food and Drug Administration(FDA) marketing approval of FUROSCIX.
October 2022, entered into a secured debt financing agreement for up to $100 millionwith funds managed by Oaktree Capital Management. The Company used a portion of the proceeds to prepay all outstanding loans under its existing credit facility and intends to use the remaining available funds, together with cash on-hand, to support its commercialization efforts for FUROSCIX and other working capital and general corporate purposes.
- Continued to advance a multi-faceted launch and commercial preparedness plan, including active outreach to the largest Medicare Part D payers resulting in securing Pharmacy & Therapeutics (P&T) committee meetings to review FUROSCIX in Q4 2022.
- Presented two posters at the
Heart Failure Society of America2022 Annual Scientific Meeting highlighting the significant potential benefits – both to patients and payers – of an alternative approach to the management of congestion in patients with heart failure outside of the hospital.
- Announced positive results from the AT HOME-HF Phase 2 pilot study in chronic heart failure patients presenting to a heart failure clinic with worsening congestion and requiring augmented diuresis. The results favor FUROSCIX over a “treatment as usual” approach in a composite primary endpoint and all secondary endpoints. Notably, subjects randomized to FUROSCIX had a 37% reduction in the risk of a heart failure hospitalization compared to patients randomized to “treatment as usual” at day 30.
- Ended the third quarter with cash, cash equivalents, restricted cash and investments of $45.4 million. Subsequent to the end of the third quarter, the Company drew down the initial
$50 milliontranche from Oaktree per the debt financing agreement announced on October 10.
“The FDA approval of FUROSCIX represents a potential game changer within the heart failure treatment paradigm by allowing patients, for the first time, to self-administer IV equivalent diuresis at home either pre-admission or post discharge from the hospital,” said
“With access to the funds available through our debt financing agreement with Oaktree, we are well financed for the initial launch. We believe that we have developed an effective commercialization plan that will get FUROSCIX to patients as quickly as possible and should enable us to maximize the value of this asset for our company,”
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.
Third Quarter 2022 Financial Results and Financial Guidance
scPharmaceuticals ended the third quarter 2022 with
scPharmaceuticals reported a net loss of
Research and development expenses were
General and administrative expenses were
Based on its current operating plan, the Company has adjusted its 2022 net loss to
Conference call and Webcast Information
scPharmaceuticals’ management will host a conference call and webcast to review the Company’s third quarter results today,
Following the live webcast, a replay of the event will be archived on scPharmaceuticals’ website for one year.
FUROSCIX® (furosemide injection) 80 mg/10mL for subcutaneous use
FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with
FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema. The On-Body Infusor will deliver only an 80-mg dose of FUROSCIX.
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.
The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.
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.
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 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 for and timing of the planned commercial launch of FUROSCIX and the success of such commercialization, the potential benefits, expected costs and future plans and expectations for FUROSCIX, the expected use of proceeds from the debt facility with Oaktree, and the Company’s expected net loss for the year ending
scPharmaceuticals Inc., 781-301-6706
|Unaudited Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|THREE MONTHS ENDED
||NINE MONTHS ENDED
|Research and development||$||3,694||$||3,718||$||11,509||$||13,207|
|General and administrative||2,211||6,277||7,593||13,448|
|Total operating expenses||5,905||9,995||19,102||26,655|
|Loss from operations||(5,905||)||(9,995||)||(19,102||)||(26,655||)|
|Other income (expense)||10||(22||)||298||55|
|Net loss per share, basic and diluted||$||(0.24||)||$||(0.37||)||$||(0.76||)||$||(1.01||)|
|Weighted—average common shares outstanding, basic and diluted||27,355,454||27,401,060||27,349,279||27,382,760|
|Unaudited Consolidated Balance Sheet Data|
|Cash, cash equivalents, restricted cash and investments||$||75,460||$||45,368|
|Total stockholders’ equity||56,470||31,110|