Hydrocortisone

Reported total revenue of $10.3 million and GAAP Net Income of $0.6 million, or $0.02 per diluted shareEntered into an asset purchase agreement to acquire Increlex® (mecasermin injection)Q3 2024 product sales increased 40% over Q3 2023, representing 15th straight quarter of sequential product sales growthProduced positive quarterly GAAP net income from product sales for first time in company historyGenerated cash from operations of $2.9 million in Q3 2024Granted additional patent for ET-400Management to hold conference call today at 4:30pm ET DEER PARK, Ill., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended September 30, 2024. “Our strong product revenue growth in the third quarter allowed us to achieve positive GAAP net income from product revenue for the first time in the Company’s history and we’re pleased to reach this important milestone one quarter ahead of our original goal. We are proud of our ability to continue delivering exceptional growth, as demonstrated by our 15th straight quarter of sequential growth in product revenue, while managing the bottom line,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “This milestone is just the beginning of Eton’s growth story. With the upcoming close of the Increlex acquisition and our ET-400 PDUFA date approaching, 2025 is shaping up to be a transformational year for Eton. We are very excited about what we can achieve in the coming quarters and years,” concluded Brynjelsen. Third Quarter and Recent Business Highlights Delivered 15th straight quarter of sequential growth in product sales and reported positive GAAP net income. Eton reported third quarter 2024 product sales of $9.8 million, representing 40% growth over the prior year period, and 8% over the second quarter of 2024, driven primarily by the ongoing growth of ALKINDI SPRINKLE® and Carglumic Acid. During the quarter, Eton produced positive GAAP net income for the first time in Company history from product revenue alone. Entered into an asset purchase agreement to acquire Increlex® (mecasermin injection) from Ipsen S.A. The transaction, which was announced in October, will add a high-value biologic product to the Company’s commercial portfolio. The product is synergistic with Eton’s existing pediatric endocrinology call point, and the acquisition is expected to be accretive to 2025 earnings. The Company anticipates the transaction closing near year-end 2024. New Drug Application (NDA) for ET-400 accepted by the U.S. Food and Drug Administration (FDA). In July, the FDA accepted Eton’s NDA for ET-400, its proprietary patented formulation of hydrocortisone oral solution and assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025. Eton expects to manufacture product inventory in the fourth quarter of 2024 to enable a commercial launch promptly after the expected approval in 2025. The Company believes the introduction of ET-400 will enable it to capture a greater percentage of the oral hydrocortisone market and, together with ALKINDI SPRINKLE, the two products are expected to achieve combined peak sales of more than $50 million annually. Granted additional patent for ET-400. On November 5, Eton was granted an additional patent for ET-400 by the United States Patent & Trademark Office (USPTO), further strengthening the IP protection for the product. The patent, which expires in 2043, covers hydrocortisone oral liquid formulations and is expected to be listed in the FDA’s Orange Book upon ET-400’s approval. Strong growth of ALKINDI SPRINKLE and the Company’s metabolic portfolio. ALKINDI SPRINKLE reported 55% year-over-year revenue growth in Q3 2024. Carglumic Acid also reported another quarter of strong sequential and year-over-year growth. The commercial availability of Betaine Anhydrous, Nitisinone, and PKU GOLIKE® has helped increase the frequency of the Company’s interactions with potential Carglumic Acid prescribers. Initiation of ET-600 pivotal study. ET-600’s pivotal bioequivalence study has been initiated. ET-600 is under development for the treatment of the pediatric endocrinology condition diabetes insipidus. If the study results are positive, Eton anticipates submitting an NDA for the product in the first quarter of 2025. Third Quarter Financial Results Net Revenue: Net sales for the third quarter of 2024 were $10.3 million compared to $7.0 million in the prior year period. Net sales in the current year period included $0.5 million of licensing payments received from out-licensing of the company’s DS-200 product. Product sales and royalty revenue were $9.8 million for the third quarter of 2024, an increase of 40% compared to $7.0 million in the prior year period, and an increase of 8% over the second quarter of 2024. The year-over-year increase in product sales revenue was primarily driven by growth in ALKINDI SPRINKLE and Carglumic Acid. Gross Profit: Gross profit for the third quarter of 2024 was $6.3 million compared to $4.4 million in the prior year period. Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2024 were $0.5 million compared to $0.6 million in the prior year period as a result of decreased expenses associated with ET-400 project development activities. General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2024 were $5.3 million compared to $4.3 million in the prior year period, mainly due to increased sales and marketing activities, legal expenses, and employee-related expenses. Net Income: Net income for the third quarter of 2024 was $0.6 million or $0.02 per basic and diluted share. In the prior year period, net loss was $0.6 million, or $0.02 per basic and diluted share. Cash Position: As of September 30, 2024, Eton had cash and cash equivalents of $20.3 million. The Company generated $2.9 million of operating cash flow during the quarter. The Company expects to generate positive cash flow in the fourth quarter and to fund its acquisition of Increlex with cash on hand and an expansion of its existing credit facility. Conference Call and Webcast Information As previously announced, Eton Pharmaceuticals will host a its third quarter 2024 conference call as follows: Date November 12, 2024Time 4:30 p.m. ET (3:30 p.m. CT)Dial in Toll-free: 888-596-4144 Non-toll free: 646-968-2525 Access Code: 1144771Webcast: Click Here In addition to taking live questions from participants on the conference call, management will be answering emailed questions from investors. Investors can email questions to: investorrelations@etonpharma.com. The live webcast can also be accessed on the Investors section of Eton’s website at https://ir.etonpharma.com/. An archived webcast will be available on Eton’s website approximately two hours after the completion of the event and for 30 days thereafter. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com Eton Pharmaceuticals, Inc.Condensed Statements of Operations(In thousands, except per share amounts)(Unaudited) For the three months ended For the nine months ended September 30, September 30, September 30, September 30, 2024 2023 2024 2023 Revenues: Licensing revenue $500 $— $500 $5,500 Product sales and royalties 9,824 7,028 26,864 18,829 Total net revenues 10,324 7,028 27,364 24,329 Cost of sales: Licensing revenue 270 — 270 — Product sales and royalties 3,752 2,625 10,159 6,898 Total cost of sales 4,022 2,625 10,429 6,898 Gross profit 6,302 4,403 16,935 17,431 Operating expenses: Research and development 505 615 4,126 2,275 General and administrative 5,288 4,336 16,035 14,355 Total operating expenses 5,793 4,951 20,161 16,630 Income (loss) from operations 509 (548) (3,226) 801 Other income (expense): Other income — — — 800 Interest expense, net (8) (31) (71) (281)Total other income (expense) (8) (31) (71) 519 Income (loss) before income tax expense 501 (579) (3,297) 1,320 Income tax expense (benefit) (126) — (72) — Net income (loss) $627 $(579) $(3,225) $1,320 Net income (loss) per share, basic $0.02 $(0.02) $(0.12) $0.05 Weighted average number of common shares outstanding, basic 25,900 25,719 25,814 25,613 Net income (loss) per share, diluted $0.02 $(0.02) $(0.12) $0.05 Weighted average number of common shares outstanding, diluted 26,550 25,719 25,814 26,002 Eton Pharmaceuticals, Inc.Condensed Balance Sheets(in thousands, except share and per share amounts) September 30, 2024 December 31, 2023 (Unaudited) Assets Current assets: Cash and cash equivalents $20,261 $21,388 Accounts receivable, net 5,591 3,411 Inventories 1,938 911 Prepaid expenses and other current assets 1,959 1,129 Total current assets 29,749 26,839 Property and equipment, net 33 58 Intangible assets, net 5,854 4,739 Operating lease right-of-use assets, net 193 92 Other long-term assets, net 12 12 Total assets $35,841 $31,740 Liabilities and stockholders’ equity Current liabilities: Accounts payable $2,684 $1,848 Debt, net of unamortized discount 4,125 5,380 Accrued Medicaid rebates 8,047 3,627 Other accrued liabilities 4,878 5,386 Total current liabilities 19,734 16,241 Operating lease liabilities, net of current portion 126 22 Total liabilities 19,860 16,263 Commitments and contingencies (Note 11) Stockholders’ equity Common stock, $0.001 par value; 50,000,000 shares authorized; 25,836,204 and 25,688,062 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 26 26 Additional paid-in capital 123,250 119,521 Accumulated deficit (107,295) (104,070)Total stockholders’ equity 15,981 15,477 Total liabilities and stockholders’ equity $35,841 $31,740 Eton Pharmaceuticals, Inc.Condensed Statements of Cash Flows(In thousands)(Unaudited) Nine months ended Nine months ended September 30, 2024 September 30, 2023Cash flows from operating activities Net Income (loss) $(3,225) $1,320 Adjustments to reconcile net income (loss) to net cash from operating activities: Stock-based compensation 2,383 2,387 Depreciation and amortization 791 576 Non-cash lease expense 53 50 Debt discount amortization 70 90 Changes in operating assets and liabilities: Accounts receivable (2,179) (1,643)Inventories (1,027) (494)Prepaid expenses and other assets 171 749 Accounts payable 836 (52)Accrued Medicaid rebates 4,420 2,342 Other accrued liabilities (559) 1,103 Net cash from operating activities 1,734 6,428 Cash flows from investing activities Purchases of product license rights (1,868) — Purchases of property and equipment (14) — Net cash from investing activities (1,882) — Cash flows from financing activities Repayment of long-term debt (1,155) (770)Proceeds from employee stock purchase plan and stock option exercises 176 288 Payment of tax withholding related to net share settlement of stock option exercises — (181)Net cash from financing activities (979) (663) Change in cash and cash equivalents (1,127) 5,765 Cash and cash equivalents at beginning of period 21,388 16,305 Cash and cash equivalents at end of period $20,261 $22,070 Supplemental disclosures of cash flow information Cash paid for interest $525 $638 Cash paid for income taxes $181 $— Right-of-use assets and liabilities obtained due to lease renewal $153 $29 Supplemental disclosures of non-cash transactions in investing and financing activities Relative fair value of warrants issued in connection with debt $1,170 $—

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )-- Spruce Biosciences, Inc . (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for endocrine and neurological disorders with significant unmet medical need, today reported financial results for the third quarter ended September 30, 2024 and provided corporate updates. “ We remain on track to report primary efficacy and safety data plus interim data from the open-label extension of the CAHmelia-204 study of tildacerfont in adult CAH patients in December 2024. At the same time, we will also report topline dose-ranging efficacy and safety data from the CAHptain-205 study of tildacerfont in adult and pediatric CAH patients,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce. “ It is an honor to continue partnering with the CAH community to open a new chapter in the management of CAH. We recognize the potentially transformative impact of tildacerfont, and we have a strong sense of urgency to deliver on our commitment to CAH patients.” Corporate Updates CAHmelia-204 Study of Tildacerfont in Adult CAH : CAHmelia-204 is a Phase 2b, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of tildacerfont in reducing supraphysiologic glucocorticoid (GC) usage, a potentially registrational endpoint, in 90 adults with classic CAH on supraphysiologic doses of GCs with normal or near normal levels of androstenedione (A4) at baseline. In the first part of the clinical trial, patients were randomized to receive 200mg of tildacerfont once-daily (QD) or placebo for 24 weeks. During the second part of the clinical trial, all patients received 200mg of tildacerfont QD for 52 weeks. Throughout the trial, tapering of GCs is guided according to a pre-specified algorithm and continue to physiologic replacement levels, as long as patients remain well controlled based on standard biomarkers and clinical assessments. The primary endpoint of this clinical trial is the absolute change in daily GC dose in hydrocortisone equivalents (HCe) from baseline through week 24. CAHptain-205 Study of Tildacerfont in Adult and Pediatric CAH : CAHptain-205 is a Phase 2 open-label clinical trial, which utilizes a sequential nine cohort design, to evaluate the safety, efficacy, and pharmacokinetics of tildacerfont in adults and children between two and 17 years of age. Cohorts 1-3 evaluated weight-adjusted doses of tildacerfont between 50mg QD and 200mg QD in pediatric CAH patients between two and 17 years of age, and assessed changes in androgen levels over 12 weeks of treatment as well as the ability to reduce daily GC dose based on A4 normalization. Cohorts 4-9 are evaluating weight-adjusted doses of tildacerfont of 200mg twice-daily (BID) and 400mg BID in adults and children between two and 17 years of age and is assessing changes in androgen levels over four weeks of treatment. An optional open-label extension period will provide additional open-label treatment with tildacerfont to provide long-term safety data for up to two years. Anticipated Upcoming Milestones Topline results from the CAHmelia-204 clinical trial of tildacerfont 200mg QD in adult classic CAH patients on supraphysiologic doses of GCs with normal or near normal levels of A4 anticipated in December 2024 Topline results from the CAHptain-205 clinical trial of tildacerfont 200mg BID and 400mg BID adult and pediatric cohorts anticipated in December 2024 End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration anticipated in the first half of 2025 Third Quarter 2024 Financial Results Cash and Cash Equivalents: Cash and cash equivalents as of September 30, 2024 were $60.1 million. Cash and cash equivalents are expected to allow the company to fund its current operating plan through the end of 2025. Collaboration Revenue: Collaboration revenue was $0.6 million and $4.2 million for the three and nine months ended September 30, 2024, respectively, compared to $3.1 million and $7.2 million for the same periods in 2023. The collaboration revenue reflects the partial recognition of the $15.0 million upfront payment the company received in April 2023 in connection with the collaboration and license agreement with Kaken Pharmaceutical. Research and Development (R&D) Expenses: R&D expenses for the three and nine months ended September 30, 2024 were $6.6 million and $25.0 million, respectively, compared to $13.5 million and $38.3 million for the same periods in 2023. The overall decrease in R&D expenses was primarily driven by the decrease in clinical development and manufacturing expenses related to the termination of the CAHmelia-203 study, completion of enrollment in the company’s CAHmelia-204 study, and completion of the Phase 2 POWER study in polycystic ovary syndrome, offset by an increase in expenses related to the ongoing CAHptain-205 study. General and Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2024 were $3.5 million and $11.3 million, respectively, compared to $3.2 million and $9.7 million for the same periods in 2023. Total Operating Expenses: Total operating expenses for the three and nine months ended September 30, 2024 were $10.0 million and $36.3 million, respectively, compared to $16.7 million and $48.0 million for the same periods in 2023. Operating expenses include non-cash stock-based compensation expenses of $1.1 million and $4.4 million for the three and nine months ended September 30, 2024, respectively, compared to $1.1 million and $3.4 million for the same periods in 2023. Net Loss: Net loss for the three and nine months ended September 30, 2024 was $8.7 million and $29.5 million, respectively, compared to $12.4 million and $38.0 million for the same periods in 2023. Upcoming Investor Conferences Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer, will present at the Guggenheim Securities Healthcare Innovation Conference on November 11, 2024, at 3:30 p.m. ET. Interested parties can access the live webcast here . An archived copy of the webcast will be available on the events section of the company’s investor relations website for approximately 90 days. About Spruce Biosciences Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for endocrine and neurological disorders with significant unmet medical need. Spruce is developing its product candidate, tildacerfont, an oral, second-generation CRF 1 receptor antagonist, for the treatment of congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS) and major depressive disorder (MDD). To learn more, visit www.sprucebio.com and follow us on X , LinkedIn , Facebook and YouTube . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the design, results, conduct, progress and timing of Spruce’s clinical trials; Spruce’s expectations regarding reporting results of its clinical trials in 2024; Spruce’s plans to meet with the FDA to discuss the potential registrational path forward of tildacerfont for adult and pediatric classic CAH; and Spruce’s product candidate, strategy and regulatory matters. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “continue,” “will,” “potential,” “on track,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. SPRUCE BIOSCIENCES, INC. CONDENSED BALANCE SHEETS (unaudited) (in thousands, except share and per share amounts) September 30, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents $ 60,055 $ 96,339 Prepaid expenses 2,658 3,876 Other current assets 860 1,968 Total current assets 63,573 102,183 Right-of-use assets 998 1,181 Other assets 531 582 Total assets $ 65,102 $ 103,946 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 1,799 $ 3,332 Accrued expenses and other current liabilities 7,740 14,600 Term loan, current portion 1,622 1,622 Deferred revenue, current portion 697 4,911 Total current liabilities 11,858 24,465 Lease liabilities, net of current portion 809 1,019 Term loan, net of current portion 524 1,717 Other liabilities 273 236 Total liabilities 13,464 27,437 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued or outstanding as of September 30, 2024 and December 31, 2023 — — Common stock, $0.0001 par value; 200,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 41,302,599 and 41,029,832 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 4 4 Additional paid-in capital 278,343 273,737 Accumulated deficit (226,709 ) (197,232 ) Total stockholders’ equity 51,638 76,509 Total liabilities and stockholders’ equity $ 65,102 $ 103,946 SPRUCE BIOSCIENCES, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except share and per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Collaboration revenue $ 602 $ 3,073 $ 4,214 $ 7,202 Operating expenses: Research and development 6,554 13,494 24,961 38,332 General and administrative 3,456 3,237 11,330 9,699 Total operating expenses 10,010 16,731 36,291 48,031 Loss from operations (9,408 ) (13,658 ) (32,077 ) (40,829 ) Interest expense (71 ) (119 ) (251 ) (377 ) Interest income and other expense, net 808 1,423 2,851 3,237 Net loss (8,671 ) (12,354 ) (29,477 ) (37,969 ) Other comprehensive gain, net of tax: Unrealized gain on available for sale securities — 52 — 555 Total comprehensive loss $ (8,671 ) $ (12,302 ) $ (29,477 ) $ (37,414 ) Net loss per share, basic and diluted $ (0.21 ) $ (0.30 ) $ (0.72 ) $ (1.01 ) Weighted-average shares of common stock outstanding, basic and diluted 41,302,599 40,710,692 41,187,766 37,751,865