Tinnitus

Generated 4Q 2023 net FUROSCIX® revenue of $6.1 million, at the upper end of the range provided in January and representing sequential growth of 61% from $3.8 million in 3Q 2023 Generated full-year net FUROSCIX® revenue of $13.6 million, at the upper end of the range provided in January Ended 2023 with cash, cash equivalents and short-term investments of $76 million 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, up 61% sequentially as compared to $3.8 million in the third quarter of 202313,542 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 20234,592 written doses payer cleared or pending 5.9 doses per prescription1,696 unique prescribers of FUROSCIX from launch through end of the year, up 52% from 1,119 from launch through the end of the third quarter2,331 FUROSCIX in-services completed from launch through end of the year, up from 1,806 from launch through the end of the third quarterGross-to-net discount of 18% from launch through the end of the year, as compared to 21% from launch through the end of third quarterInventory levels at specialty pharmacy partners remained consistent from September 30, 2023 levels 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 61%, which we believe reflects growing awareness and acceptance of FUROSCIX as a key component of a new heart failure treatment paradigm,” stated John Tucker, President, and Chief Executive Officer of scPharmaceuticals. “Our reported gross-to-net discount of 18% declined from launch through the end of Q4 as compared to 21% from launch through the end of Q3. However, we continue to anticipate that the GTN discount will increase over time as our contracting efforts continue to evolve and mature.” “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 $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023. Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022. The increase in research and development expenses for the quarter ended December 31, 2023, was primarily due to an increase in device and pharmaceutical development costs and clinical study costs. The increase was partially offset by a decrease in employee related costs. Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022. The increase in selling, general and administrative expenses for the quarter ended December 31, 2023, was primarily due to an increase in employee related costs and commercial costs. scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022. Full-Year 2023 Product revenues were $13.6 million, and cost of product revenues were $3.8 million for the full-year 2023. Research and development expenses were $11.8 million for the full-year 2023, compared to $15.5 million for the full-year 2022. The decrease in research and development expenses for the full-year 2023 was primarily due to a decrease in clinical study and medical affairs costs, employee related costs, quality and regulatory consulting costs, and patent costs. The decrease was partially offset by an increase in pharmaceutical development costs. Selling, general and administrative expenses were $53.4 million for the full year 2023, compared to $20.6 million for the full-year 2022. The increase in selling, general and administrative expenses for the full-year 2023 was primarily due to an increase in employee related costs and commercial preparation costs, operations, quality and regulatory costs, and legal costs. The increase was partially offset by a decrease in insurance related costs. scPharmaceuticals reported a net loss of $54.8 million for the full-year 2023, compared to $36.8 million for the full-year 2022. scPharmaceuticals ended 2023 with $76 million in cash, cash equivalents and short-term investments, compared to $118.4 million as of December 31, 2022. 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 MirandascPharmaceuticals Inc., 781-301-6869kmiranda@scpharma.com Investors:PJ KelleherLifeSci Advisors, 617-430-7579pkelleher@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

Acquisition adds four digital treatment programs targeting significant populations to Mahana’s growing digestive health portfolio Combined company now has global reach with Cara Care’s IBS program currently being prescribed and reimbursed in Germany Mahana positioned to be the partner of choice for autoimmune and gastroenterology focused biopharmaceutical companies seeking to improve patient outcomes with complementary treatments SAN FRANCISCO--(BUSINESS WIRE)-- Mahana Therapeutics, a leading provider of digital chronic condition management programs, announced today that it has acquired Berlin-based HiDoc Technologies GmbH, operating as Cara Care, a leader in digital digestive healthcare. This combination creates a global company offering the most comprehensive digestive health portfolio currently addressing Irritable Bowel Syndrome (IBS), Irritable Bowel Disorder (IBD), Celiac Disease and Heartburn, with an exciting pipeline focused on Tinnitus, Pruritus, and Vulvodynia. The acquisition of Cara Care is expected to accelerate Mahana’s market entry in Europe where the reimbursement of digital programs is outpacing the United States. Cara Care’s IBS prescription-based digital program is currently being prescribed, and reimbursed, to thousands of patients in Germany. The combined entity is now poised to expand its commercialization efforts beyond Germany to France and the United Kingdom as reimbursement of digital programs continues to improve across Europe. Mahana’s and Cara Care's self-guided, digital chronic condition management programs employ a proprietary cognitive behavioral therapy (CBT) platform that complements consumer health and pharmacological treatments to address high unmet needs associated with digestive, hearing, dermatology, and women’s health chronic conditions. When used with standard of care treatments, these programs can dramatically improve outcomes, patient treatment satisfaction, quality of care and overall patient quality of life while reducing associated provider workload burden. "The combination of Mahana and Cara Care is an incredible opportunity to bring together our complementary expertise in chronic digestive health conditions and create a one-of-a-kind global offering of digital programs across the Digestive, Hearing, Dermatology, and Women’s Health markets. The transaction will accelerate our mission of reaching the millions of patients suffering from these chronic conditions including through partnerships, such as our ongoing collaboration with Bayer,” said Simon Levy, CEO. “Our ability to pair our digital programs with conventional treatment options will improve overall outcomes, patient satisfaction and has the potential to greatly enhance the lifetime patient value for our consumer health and biopharmaceutical partners.” “Cara Care is delighted to join the Mahana team to accelerate the expansion of our products within Germany and across other European markets. We see this as a great opportunity to leverage Mahana’s unique distribution and partnership model and to expand our compelling offering in Digestive Health to the US marketplace with minimal overlap,” said Jim Mapes, CEO of HiDoc Technologies. The combined company operates across the United States, Germany, and the United Kingdom with both FDA-cleared and digital wellness programs for IBS and Tinnitus currently prescribed or offered by thousands of healthcare providers and used by tens of thousands of patients worldwide, and an exciting pipeline to reach the millions of patients suffering from IBD, Heartburn, Celiac Disease, Pruritus and Vulvodynia. Mahana is backed by prominent investors including JAZZ Venture Partners, Lux Capital, Gurnet Point Capital, Main Street Advisors, KKCG, and Asabys Partners. Financial terms of the acquisition were not disclosed. About Mahana Therapeutics Mahana Therapeutics is a leading developer of digital chronic condition management programs that are designed to empower patients with chronic conditions to live fuller lives. The company’s first product, Mahana IBS, was the first digital therapeutic to receive FDA clearance for the treatment of IBS and provides cognitive behavioral therapy (CBT) to adults with IBS. More information is available at . About HiDoc Technologies, GmBH Berlin-based digital health company HiDoc Technologies GmbH, dba Cara Care, offers the Cara Care digital therapeutic app for digestive diseases, which spans medication management as well as dietary and mental health interventions to improve gastrointestinal health. The Cara Care app – available for iOS and Android – helps fill the gaps between doctor visits for gastrointestinal disease patients. For more information, visit . View source version on businesswire.com: Contacts Justin Zamirowski press@mahanatx.com Colin Sanford colin@bioscribe.com Source: Mahana Therapeutics View this news release online at:

High-dose glucocorticoid regimes do not improve outcomes compared to standard dose but carry greater risk of side effects Glucocorticoid treatment does not result in complete recovery in 60% of patients New treatment options for sudden hearing loss patients are urgently needed BERLIN--(BUSINESS WIRE)-- High-dose glucocorticoids are no more effective than the standard-dose in treating patients with sudden hearing loss. They are also associated with more side effects and significantly worse outcomes for speech recognition and tinnitus perception. Additionally, 60% of patients treated with the standard dose had not fully recovered by the end of the study. This clinical study, led by Prof. Stefan Plontke from the University Medicine Halle, evaluated the efficacy of different doses of glucocorticoids in over 300 sudden hearing loss patients and is published in NEJM Evidence. These results raise the possibility that glucocorticoids may not be sufficiently effective in treating this condition. This press release features multimedia. View the full release here: Prof. Stefan Plontke, principal investigator of the study at the University Medical Center Halle (Photo: University Medicine Halle). Sudden hearing loss can drastically impair speech understanding and affect a patient’s daily life. Glucocorticoids are prescribed worldwide as the standard-of-care. However, in certain circumstances their side effects can be severe, and it remains unclear whether they provide meaningful improvement for patients. "These drugs have been used globally for 50 years as the standard of care for sudden hearing loss, still there is no reliable scientific evidence for this practice.", explains study leader Stefan Plontke, underscoring the increasing need for new treatments. Many companies are exploring alternatives. However, there is currently only one clinical trial with a new active substance in which patients can participate: The compound AC102 outperformed the widely used cortisone-like dexamethasone in preclinical models of hearing loss, likely because it specifically targets damaged sensory cells and the auditory nerve. Clinical trials are now testing whether this effect is comparable in humans. "We are not surprised by the HODOKORT study results. Glucocorticoids as anti-inflammatory drugs are a good treatment option for many conditions. However, there is no convincing mode-of-action for the treatment of sudden hearing loss with steroids, as our own research has shown," says Dr. Reimar Schlingensiepen, CEO of AudioCure Pharma. After 50 years of treating sudden hearing loss with glucocorticoids, a new and effective drug for this condition would represent a much-needed paradigm shift. Original Study: Plontke, et al. NEJM Evid 2024;3(1) DOI:10.1056/EVIDoa2300172 View source version on businesswire.com: Contacts AudioCure Pharma GmbH Frauke Luers Phone: +49 30 2218 397-0 E-Mail: pr@ac-clinical.com Web: Source: AudioCure Pharma GmbH Smart Multimedia Gallery Photo Prof. Stefan Plontke, principal investigator of the study at the University Medical Center Halle (Photo: University Medicine Halle). Logo View this news release and multimedia online at: