scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update
- Strong net FUROSCIX revenue of $6.1 million in Q4 2023, a 61% sequential growth
- Full-year net FUROSCIX revenue reached $13.6 million
- Ended 2023 with $76 million in cash, cash equivalents, and short-term investments
- Plans to expand FUROSCIX indications with a pivotal PK study and sNDA submission to the FDA
- Reported a net loss of $13.8 million in Q4 2023 and $54.8 million for the full year 2023
- Net loss of $13.8 million in Q4 2023 and $54.8 million for the full year 2023
- Increase in selling, general, and administrative expenses compared to the previous year
- Decrease in cash, cash equivalents, and short-term investments from $118.4 million in 2022 to $76 million in 2023
Insights
The reported fourth-quarter revenue growth of 61% for scPharmaceuticals' FUROSCIX is a strong indicator of the product's market acceptance and growing sales momentum. The sequential increase from $3.8 million in the third quarter to $6.1 million in the fourth quarter suggests robust demand and effective market penetration strategies. The gross-to-net discount improvement from 21% to 18% indicates a favorable pricing dynamic, which could lead to improved margins over time. However, the expectation of an increasing discount due to contracting efforts may temper the margin expansion outlook.
Investors should note the increase in selling, general and administrative expenses, which more than doubled from the previous year, reflecting heightened commercial activity and possibly an expanded workforce. While necessary for growth, this increase in expenses has contributed to a net full-year loss of $54.8 million, deepening from $36.8 million in the previous year. The company's cash position of $76 million, while lower than the previous year-end, appears sufficient to support ongoing operations and R&D efforts in the near term.
scPharmaceuticals' strategic focus on lifecycle management and expansion of FUROSCIX's indications, such as the potential inclusion for NYHA Class IV heart failure patients and chronic kidney disease, is an important aspect for investors to consider. The initiation of a pivotal pharmacokinetic study for an 80mg/1mL auto-injector represents innovation in drug delivery systems, potentially enhancing patient adherence and expanding the addressable market. The sNDA submissions and formulary inclusion with a large government retiree payer are key regulatory and market access milestones that could significantly impact future revenue streams.
It is also critical to monitor the clinical and regulatory developments, such as the FDA's review of the sNDA for expanding FUROSCIX's indication. Positive outcomes in these areas could further validate the product's efficacy and safety, leading to broader market adoption and potentially impacting stock valuation positively.
The reported metrics such as the number of FUROSCIX doses written and filled, the increase in unique prescribers and completed in-services provide a quantitative measure of market engagement and adoption among healthcare providers. The 44% sequential increase in filled doses and the 52% increase in unique prescribers from the previous quarter are particularly encouraging, as they suggest a growing prescriber base and user acceptance. The addition of 1.1 million lives with preferred access to FUROSCIX through formulary placement is a significant market expansion that can drive future revenue growth.
Furthermore, the company's sales to integrated delivery networks, including a large order to one of the largest closed IDNs in the United States, demonstrates the product's penetration into key healthcare networks, which is often a critical factor for sustained growth in the pharmaceutical sector.
Generated 4Q 2023 net FUROSCIX® revenue of
Generated full-year net FUROSCIX® revenue of
Ended 2023 with cash, cash equivalents and short-term investments of
Company to host investor conference call and webcast today, Wednesday, March 13, at 4:30pm ET
BURLINGTON, Mass., March 13, 2024 (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 financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update.
Business Update
- For the fourth quarter ended December 31, 2023, scPharmaceuticals reports:
- Net FUROSCIX revenue of
$6.1 million , up61% sequentially as compared to$3.8 million in the third quarter of 2023 - 13,542 total FUROSCIX doses written, up
56% sequentially as compared to 8,676 in the third quarter of 2023- 7,016 FUROSCIX doses filled, up
44% sequentially from 4,861 in the third quarter of 2023 - 4,592 written doses payer cleared or pending
- 7,016 FUROSCIX doses filled, up
- 5.9 doses per prescription
- 1,696 unique prescribers of FUROSCIX from launch through end of the year, up
52% from 1,119 from launch through the end of the third quarter - 2,331 FUROSCIX in-services completed from launch through end of the year, up from 1,806 from launch through the end of the third quarter
- Gross-to-net discount of
18% from launch through the end of the year, as compared to21% from launch through the end of third quarter - Inventory levels at specialty pharmacy partners remained consistent from September 30, 2023 levels
- Net FUROSCIX revenue of
- Reported that, as of November 1, 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.
- Continued to see sales of FUROSCIX to integrated delivery networks (IDNs), including a large direct order in late Q4 to one of the largest closed IDN in the United Sates.
- On track to initiate a pivotal pharmacokinetic (PK) study in Q2 to support development of an 80mg/1mL auto-injector. If successful, scPharmaceuticals plans to submit a New Drug Application (NDA) to the FDA by the end of 2024.
- Advanced plans to submit an sNDA to the FDA next month seeking expansion of the FUROSCIX indication to include patients suffering from chronic kidney disease (CKD).
- Announced that the Company’s sNDA submission to the FDA seeking to expand the FUROSCIX indication to include New York Heart Association Class IV heart failure patients is currently under review by the FDA.
- Ended the fourth quarter of 2023 with cash, cash equivalents and short-term investments of
$76.0 million .
“We ended 2023 on a strong note, generating net FUROSCIX sequential revenue growth of
“Our reported gross-to-net discount of
“Also, during the fourth quarter, we continued to advance the life cycle management and long-term growth initiatives for FUROSCIX that we previewed last quarter. These include the potential expansion of the FUROSCIX indication to include NYHA Class IV heart failure patients, which is currently under review by FDA, an additional indication in chronic kidney disease, for which we plan to file with the FDA next month , and the development of an auto-injector that would complement the current on-body infusor, a PK study for which we plan to initiate in the next few weeks. We continue to advance these initiatives while at the same time successfully driving uptake of FUROSCIX, and both our fourth quarter results and leading indicators confirm that FUROSCIX acceptance and utilization among heart failure specialists is accelerating,” Mr. Tucker concluded.
Fourth Quarter and Full-Year 2023 Financial Results and Financial Guidance
Fourth Quarter 2023
Product revenues were
Research and development expenses were
Selling, general and administrative expenses were
scPharmaceuticals reported a net loss of
Full-Year 2023
Product revenues were
Research and development expenses were
Selling, general and administrative expenses were
scPharmaceuticals reported a net loss of
scPharmaceuticals ended 2023 with
As of December 31, 2023, scPharmaceuticals’ total shares outstanding was 35,968,510.
Conference call and webcast information
scPharmaceuticals’ management will host a conference call and webcast to review the Company’s fourth quarter and full-year 2023 results today, Wednesday, March 13, at 4:30 p.m. ET. Participants should dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) with the conference code 13744172.
To access the Call me™ feature, which avoids having to wait for an operator, click here.
A link to the live webcast can be found here.
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 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. 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.
For more details, please read the 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.
Forward-Looking Statements
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 potential market impact and benefits of FUROSCIX and the success of the commercialization of FUROSCIX, the trial initiation, anticipated results, clinical design, potential regulatory submissions, approvals and timing thereof of the PK study, the potential expansion of the FUROSCIX indication to include NYHA Class IV heart failure patients and the timing thereof, the potential for continued sales of FUROSCIX to IDNs, the potential expansion of the FUROSCIX indication to include treatment of edema in patients with chronic kidney disease, and participation in upcoming events and presentations. 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, our dependence on the commercial success of FUROSCIX and, if approved, our other product candidates, risks related to the receipt of regulatory approval for our product candidates, risks related to our ability to manufacture, or the ability of third parties to deliver, sufficient product for commercialization of FUROSCIX or any of our product candidates, if approved , risks related to our history of operating losses, and the risk that global economic factors and uncertainties will impact the Company’s 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 sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, 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 Miranda
scPharmaceuticals Inc., 781-301-6869
kmiranda@scpharma.com
Investors:
PJ Kelleher
LifeSci Advisors, 617-430-7579
pkelleher@lifesciadvisors.com
| scPharmaceuticals Inc. | |||||||||||||||
| Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| THREE MONTHS ENDED DECEMBER 31, | YEAR ENDED DECEMBER 31, | ||||||||||||||
| 2022 | 2023 | 2022 | 2023 | ||||||||||||
| Product revenues, net | $ | - | $ | 6,096 | $ | - | $ | 13,593 | |||||||
| Operating expenses: | |||||||||||||||
| Cost of product revenues | $ | - | $ | 1,773 | $ | - | $ | 3,811 | |||||||
| Research and development | 2,326 | 3,338 | 15,533 | 11,809 | |||||||||||
| Selling, general and administrative | 7,176 | 16,242 | 20,624 | 53,369 | |||||||||||
| Total operating expenses | 9,502 | 21,353 | 36,157 | 68,989 | |||||||||||
| Loss from operations | (9,502 | ) | (15,257 | ) | (36,157 | ) | (55,396 | ) | |||||||
| Other (expense) income | 1,363 | 2,412 | 1,418 | 3,605 | |||||||||||
| Interest income | 850 | 1,125 | 1,203 | 5,104 | |||||||||||
| Interest expense | (1,959 | ) | (2,092 | ) | (3,302 | ) | (8,123 | ) | |||||||
| Net loss | $ | (9,248 | ) | $ | (13,812 | ) | $ | (36,838 | ) | $ | (54,810 | ) | |||
| Net loss per share, basic and diluted | $ | (0.30 | ) | $ | (0.35 | ) | $ | (1.30 | ) | $ | (1.42 | ) | |||
| Weighted—average common shares outstanding, basic and diluted | 31,253,909 | 38,786,956 | 28,358,502 | 38,513,747 | |||||||||||
| scPharmaceuticals Inc. | ||||||||
| Consolidated Balance Sheet Data | ||||||||
| (in thousands) | AS OF DECEMBER 31, | |||||||
| 2022 | 2023 | |||||||
| Cash, cash equivalents, restricted cash and investments | $ | 118,368 | $ | 76,013 | ||||
| Working capital | 115,892 | 79,804 | ||||||
| Total assets | 124,195 | 94,479 | ||||||
| Term loan | 36,794 | 38,811 | ||||||
| Accumulated deficit | (226,536 | ) | (281,346 | ) | ||||
| Total stockholders’ equity | 72,433 | 37,218 | ||||||
FAQ
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