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Eton Pharmaceuticals, Inc. (ETON)

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  • Eton Pharmaceuticals Announces Availability of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) in the United States
    GlobeNewswire

    Eton Pharmaceuticals Announces Availability of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) in the United States

    * ALKINDI® SPRINKLE is now exclusively available through AnovoRx Specialty Pharmacy. To support patient access to ALKINDI® SPRINKLE, Eton has established the Eton Cares Program®. DEER PARK, Ill., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the full availability of ALKINDI® SPRINKLE for sale and distribution in the United States. The U.S. Food and Drug Administration (FDA) has approved ALKINDI® SPRINKLE (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age. ALKINDI® SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children.ALKINDI® SPRINKLE will be available exclusively through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. AnovoRx will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program will complete prescription fulfillment, insurance benefits investigation, educational support, aid qualified patients to obtain financial assistance along with other services designed to help patients access treatment. To enroll patients in the program and prescribe ALKINDI® SPRINKLE, clinicians will need to complete a patient referral form available at www.alkindisprinkle.com.“ALKINDI® SPRINKLE is a very welcome treatment option for children who, for over 60 years, were forced to rely on adult-strength hydrocortisone to treat adrenocortical insufficiency,” said Mitchell Geffner MD, co-director, Congenital Adrenal Hyperplasia (CAH) Comprehensive Care Clinic and Professor of Pediatrics, Keck School of Medicine of University of Southern California. “Low-dose options, as low as 0.5 mg, allow for more accurate and individualized dosing for patients.” The FDA approval of ALKINDI® SPRINKLE was supported by six clinical studies, including the first and only interventional Phase III study of oral hydrocortisone for Pediatric AI in neonates to children under eight years of age. ALKINDI SPRINKLE achieved significant increases in cortisol levels from baseline (P<0.0001) and was found to be well tolerated with no serious adverse events. Prior to the approval of ALKINDI® SPRINKLE, oral hydrocortisone was only FDA-approved in tablet formulations of 5 mg and stronger. Many pediatric patients require significantly lower doses and the flexibility of precision titration. ALKINDI® SPRINKLE will be available in 0.5-mg, 1-mg, 2-mg, and 5-mg strengths, allowing clinicians greater flexibility to individualize dosing based on each patient’s needs in accordance with the instructions for dosage and administration. About Pediatric Adrenocortical Insufficiency Pediatric adrenocortical Insufficiency (AI) is a relatively rare disease characterized by an inability to synthesize and release cortisol, and sometimes aldosterone. When due to congenital adrenal hyperplasia (CAH), the most common form of pediatric AI, there will also be excessive androgens (resulting in masculinized external genitalia in affected females and, without proper treatment, the potential for precocious puberty, premature growth termination, and short stature in both sexes). Patients with primary or central (secondary and tertiary) AI lack appropriate levels of cortisol in their system. Diminished cortisol in the system may result in deadly consequences such as adrenal crisis. To survive, patients with AI must replace the missing cortisol daily. Eton estimates that pediatric AI affects between 5,000 and 11,000 children in the United States. About ALKINDI SPRINKLE ALKINDI® SPRINKLE is an immediate-release oral hydrocortisone granule preparation that has been specifically designed to meet the dosing needs of pediatric patients with adrenocortical insufficiency. Prior to ALKINDI® SPRINKLE’s approval, parent caregivers have had to cut or split higher-strength hydrocortisone tablets to achieve the lower doses required for small children, which could result in inaccurate dosing. ALKINDI® SPRINKLE is manufactured using commercially proven technology in four strengths: 0.5 mg, 1 mg, 2 mg and 5 mg, to give greater dosing flexibility to clinicians. Taste-masking excipients that are acceptable for pediatric use eliminate the bitter taste of hydrocortisone. ALKINDI® SPRINKLE has a shelf -life of three years at ambient temperature and does not require refrigeration.Indications and Usage ALKINDI® SPRINKLE is a corticosteroid indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. Important Safety Information ContraindicationsALKINDI® SPRINKLE is contraindicated in patients with hypersensitivity to hydrocortisone or to any of the ingredients in ALKINDI® SPRINKLE. Anaphylactic reactions have occurred in patients receiving corticosteroids. Warning and Precautions * Adrenal Crisis: Undertreatment or sudden discontinuation of therapy may lead to adrenal insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stress events such as infections or surgery. Increase the dose during periods of stress. Switch patients who are vomiting, severely ill, or unable to take oral medications to parenteral corticosteroid formulations. * Infections: Excessive doses may increase the risks of new infections or exacerbation of latent infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic. Monitor patients for signs and symptoms of infections. Treat all infections seriously and initiate stress-dosing of corticosteroids early. * Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI® SPRINKLE to achieve the desired clinical response and monitor the patient’s growth. * Cushing Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing syndrome. Monitor patients for signs and symptoms of Cushing syndrome every 6 months; pediatric patients under one year of age may require more frequent monitoring. * Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption which may lead to inhibition of bone growth and development of osteoporosis. Use the minimum dosage of ALKINDI® SPRINKLE to achieve desired clinical response. * Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions such as euphoria, mania, psychosis with hallucinations, and delirium or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop. * Ophthalmic Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances and, if they occur, refer them to an ophthalmologist. * Gastrointestinal Adverse Reactions: Increased risk in patients with certain gastrointestinal disorders. Signs and symptoms may be masked. Adverse Reactions The most common adverse reactions from corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, and increased appetite and weight gain. About Eton Pharmaceuticals Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company currently owns or receives royalties from three FDA-approved approved products, including ALKINDI® SPRINKLE, Biorphen®, and Alaway® Preservative Free, and has six additional products that have been submitted to the FDA.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.Company Contact: David Krempa dkrempa@etonpharma.com 612-387-3740

  • Forecast: Analysts Think Eton Pharmaceuticals, Inc.'s (NASDAQ:ETON) Business Prospects Have Improved Drastically
    Simply Wall St.

    Forecast: Analysts Think Eton Pharmaceuticals, Inc.'s (NASDAQ:ETON) Business Prospects Have Improved Drastically

    Celebrations may be in order for Eton Pharmaceuticals, Inc. (NASDAQ:ETON) shareholders, with the analysts delivering a...

  • Eton Pharmaceuticals Announces Third Quarter 2020 Financial Results
    GlobeNewswire

    Eton Pharmaceuticals Announces Third Quarter 2020 Financial Results

    DEER PARK, Ill., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today reported financial results for the third quarter ended September 30, 2020 and provided an update on business progress. “In recent weeks we submitted the last of our nine product candidates to the FDA. This is a tremendous accomplishment by our team after years of hard work. We are now turning our focus to building out a leading orphan drug commercial organization,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “Early interest in ALKINDI SPRINKLE from physicians and caregivers has been very strong and has reiterated the significant need for the product.” Recent Business Milestones * FDA approval of orphan product ALKINDI® SPRINKLE. In September, ALKINDI SPRINKLE was approved by the FDA as a replacement therapy for Adrenocortical Insufficiency in patients under 17 years of age. Eton expects to have the product commercially available by the end of November. * FDA approval of Alaway Preservative Free®. During the quarter, Alaway Preservative Free was approved by the FDA. Bausch Health plans to launch the product by the Spring of 2021 and Eton will receive a royalty on sales of the product. * Four additional NDAs submitted to the FDA. Eton, or its partners, have submitted four NDAs in the second half of 2020. Dehydrated alcohol injection, zonisamide oral suspension, and ephedrine injection have all been accepted for filing and assigned PDUFA dates of May 27, 2021; May 29, 2021; and June 18, 2021, respectively. * Successful completion of equity financing. In October, Eton closed an oversubscribed common stock offering which resulted in gross proceeds of approximately $22.5 million. The proceeds are expected to be sufficient to allow Eton to launch its current pipeline products and reach profitability. ALKINDI SPRINKLEEton anticipates having commercial availability of ALKINDI SPRINKLE by the end of November. The company’s ALKINDI SPRINKLE sales representatives have been hired, fully trained, and have begun engaging with pediatric endocrinologists. Initial interest from physicians, caregivers, and patients has been very strong and Eton expects the product to exceed the company’s original sales forecast for 2021. BiorphenThe company remains on schedule to file a Prior Approval Supplement for Biorphen vials in the fourth quarter of 2020, which should allow for a launch of the vial product in the first half of 2021. Customer feedback continues to show aversion to the ampule format but strong interest in the product in vial form. Pipeline Update ProductRegulatory Status Biorphen®Commercial ALKINDI® SPRINKLEApproved Alaway Preservative Free®Approved Dehydrated Alcohol Inj. (DS-100)Filed Lamotrigine Oral Susp. (ET-105)Filed Zonisamide Oral Susp. (ET-104)Filed Cysteine Inj. (DS-300)Filed Ephedrine Injection (ET-203)Filed Topiramate Oral Soln (ET-101)Submitted Dehydrated Alcohol Injection (DS-100). During the quarter, Eton submitted an NDA for the product and the application was accepted for filing. The application has been assigned a PDUFA date of May 27, 2021.Lamotrigine Oral Suspension (ET-105). The product’s human factors study is ongoing. One of the three requested arms has been completed, and the two remaining arms are ongoing. Eton expects the study to be completed and submitted to the FDA in the coming months, allowing for potential FDA approval as early as the first half of 2021.Zonisamide Oral Suspension (ET-104). During the quarter, Eton submitted an NDA for the product and the application was accepted for filing. The application has been assigned a PDUFA date of May 29, 2021.Cysteine Injection (DS-300). In October, Eton’s Abbreviate New Drug Application received a complete response letter from the FDA with only minor deficiencies. Eton expects to respond to the request in December, which should allow the application to receive tentative approval as early as the first quarter of 2021. The company’s paragraph IV litigation and post grant review (PGR) challenges are ongoing. Eton remains confident the innovator’s patents will be invalidated, and the company believes its product could launch as early as November 2021 if the PGR process is successful or August 2022 when the 30-month stay expires.Ephedrine Injection (ET-203). Eton’s partner submitted the product’s NDA during the quarter and the application has been accepted for filing by the FDA. The NDA has been assigned a PDUFA date of June 18, 2021.Topiramate Oral Solution (ET-101). Eton submitted an NDA for the product in October 2020. If the application is accepted for filing, Eton would expect it to be assigned a PDUFA date of Q3 2021. Financial ResultsRevenue: Eton reported revenue of ($0.2) million for the third quarter of 2020. During the quarter, Eton lowered the list price of Biorphen, which resulted in a $0.2 million reduction to revenue due to a shelf stock adjustment charge tied to inventory on hand with wholesale customers. Eton reported no revenue in the third quarter of 2019.Selling, General, & Administrative (SG&A): SG&A expenses in the third quarter of 2020 were $3.4 million compared with $1.6 million in the prior year period. The increase was driven by higher sales and marketing spending in advance of the ALKINDI SPRINKLE launch, paragraph IV litigation expenses related to the company’s cysteine injection patent challenge, and higher non-cash stock-based compensation in the period.Research & Development (R&D): R&D expenses in the third quarter of 2020 were $2.8 million compared with $3.4 million in the prior year period. The third quarter of 2020 included a $1.5 million NDA filing fee paid to the FDA. The third quarter of 2019 included a $2.0 million licensing payment related to the lamotrigine product.Net Loss: Eton reported a net loss of $6.5 million in the third quarter of 2020 compared to a net loss of $5.0 million for the same period in 2019.Cash Position: As of September 30, 2020, Eton reported cash and cash equivalents of $7.3 million. Subsequent to the quarter end, Eton closed an equity financing which resulted in gross proceeds of approximately $22.5 million. Conference Call and Webcast Information: Eton Pharmaceuticals will host a conference call and webcast today at 4:30 p.m. ET (3:30 p.m. CT). To access the conference call, please dial 1-866-795-8473 (domestic) or 1-470-495-9161 (international) and refer to conference ID 5092872. The webcast can be accessed under “Events & Presentations” in the Investors section of the Company’s website at https://ir.etonpharma.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.About Eton Pharmaceuticals Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases. The company currently owns or receives royalties from three FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, and Alaway Preservative Free®, and has six additional products that have been submitted to the FDA.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. 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,   2020   2019   2020  2019  Revenues:              Product sales, net$(161) $—  $(42) $—  Licensing revenue —   —   —   500  Total revenues  (161)  —    (42)   500                    Cost of product sales (144)  —   (14)  —                   Gross (loss) profit (17)  —   (28)   500                    Operating expenses:                Research and development 2,826   3,418   10,703   11,322  General and administrative 3,429   1,624   8,960   5,123  Total operating expenses  6,255    5,042    19,663    16,445                   Loss from operations (6,272)  (5,042)  (19,691)  (15,945)                  Other (expense) income:                Interest and other (expense) income, net (232)  77   (592)  321                   Loss before income tax expense (6,504)  (4,965)  (20,283)  (15,624)                  Income tax expense —   —   —   —                   Net loss$ (6,504) $ (4,965) $ (20,283) $ (15,624) Net loss per share, basic and diluted$ (0.31) $ (0.28) $ (1.01) $ (0.88) Weighted average number of common shares outstanding, basic and diluted 21,052   17,878   20,070   17,706  Eton Pharmaceuticals, Inc. Condensed Balance Sheets (in thousands, except share and per share amounts)  September 30, 2020  December 31, 2019   (Unaudited)     Assets        Current assets:        Cash and cash equivalents$7,332  $12,066  Accounts receivable, net —   473  Inventory 1,699   380  Prepaid expenses and other current assets 754   2,090  Total current assets 9,785   15,009           Property and equipment, net 854   1,117  Intangible assets, net 612   725  Operating lease right-of-use assets, net 63   160  Other long-term assets, net 81   61  Total assets$11,395  $17,072           Liabilities and stockholders’ equity        Current liabilities:        Accounts payable$2,208  $575  PPP loan, current portion 219   —  Accrued liabilities 792   1,388  Total current liabilities 3,219   1,963           Long-term debt, net of discount and including accrued fees 6,496   4,540  Long-term portion of PPP and EIDL loans 292   —  Operating lease liabilities, net of current portion —   19           Total liabilities 10,007   6,522           Commitments and contingencies (Note 11)                 Stockholders’ equity        Common stock, $0.001 par value; 50,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 20,988,533 and 17,877,486 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 21   18  Additional paid-in capital 85,838   74,720  Accumulated deficit (84,471)  (64,188) Total stockholders’ equity 1,388   10,550           Total liabilities and stockholders’ equity$11,395  $17,072  Eton Pharmaceuticals, Inc. Condensed Statements of Cash Flows (In thousands) (Unaudited)  Nine months ended September 30, 2020  Nine months ended  September 30, 2019  Cash flows from operating activities        Net loss$(20,283) $(15,624)          Adjustments to reconcile net loss to net cash used in operating activities:        Stock-based compensation 1,803   1,387  Common stock issued for product candidate licensing rights 1,264   —  Depreciation and amortization 490   299  Debt discount amortization 85   —  Changes in operating assets and liabilities:        Accounts receivable 473   —  Inventory (1,319)  —  Prepaid expenses and other assets 1,305   426  Accounts payable 1,633   (403) Accrued liabilities (615)  (263) Net cash used in operating activities (15,164)  (14,178)          Cash used in investing activities        Purchases of property and equipment (6)  (1,062)          Cash flows from financing activities        Proceeds from issuance of long-term debt, net of issuance costs 1,965   —  Proceeds from sales of common stock, net of offering costs 7,756   —  Proceeds from PPP and EIDL loans 511   —  Proceeds from employee stock purchase plan and stock option exercises 204   282  Net cash provided by financing activities 10,436   282           Change in cash and cash equivalents (4,734)   (14,958) Cash and cash equivalents at beginning of period 12,066   26,735  Cash and cash equivalents at end of period$7,332  $11,177           Supplemental disclosures of cash flow information        Cash paid for interest$545  $—  Cash paid for income taxes$—  $—           Supplemental disclosure of non-cash financing activity        Relative fair value of common stock warrants issued in connection with debt$94  $—  Investor Contact: David Krempa dkrempa@etonpharma.com 612-387-3740