Galmed Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Year End 2019 Financial Results
TEL AVIV, Israel, March 12, 2020 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted, oral, SCD1 modulator, currently in a Phase 3 clinical trial for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis provides today a business update and reports financial results for the three and twelve months ended December 31, 2019. The Company will host a conference call and webcast at 08:30 ET today.
Financial Summary - Full Year 2019 vs. Full Year 2018; 4Q19 vs. 4Q18:
-- For the three and twelve months ended December 31, 2019, the Company recorded a net loss of $8.3 and $20.5 million or $0.39 and $0.97 per share, respectively, compared with a net loss of $3.7 million and $9.9 million, or $0.18 and $0.54 per share, for the three and twelve months ended December 31, 2018. -- Research and development expenses were $18.2 million for the twelve months ended December 31, 2019, compared with $8.3 million for the twelve months ended December 31, 2018. For the three months ended December 31, 2019, research and development expenses totaled $7.4 million, which compares with $2.7 million for the same period in 2018. The increase during the three and twelve months is mainly due to the preparation and initiation of the ARMOR study. -- The Company incurred general and administrative expenses of $4.2 million for the twelve months ended December 31, 2019, compared with $4.4 million for the twelve months ended December 31, 2018. For the three months ended December 31, 2018, general and administrative expenses totaled $1.3 million, which compares with $1.5 million for the same period in 2018. The decrease primarily resulted from a decrease in salaries and benefits expenses of approximately $0.5 million due to lower year-end bonuses. -- During the three and twelve months ended December 31, 2019, the Company recognized a net financial income of $0.3 million and $1.9 million, respectively, compared with $0.5 and $0.9 million, respectively, during 2018. The increase during the twelve months ended December 31, 2019 is mainly due to an increase in interest income from marketable debt securities and short-term deposits, as compared to such income in 2018. -- Cash and cash equivalents, restricted cash, short-term deposits and marketable debt securities totaled $75.6 million as of December 31, 2019, compared with $90.2 million as of December 31, 2018. The decrease is mainly attributable to our $14.9 million negative cash flow from operations during the twelve months ended December 31, 2019.
Conference Call & Webcast:
Thursday, March 12(th) @ 8:30am Eastern Time.
Toll Free: 1-877-425-9470 Toll/International: 1-201-389-0878 Israel Toll Free: 1-809-406-247 Conference ID: 13699345 Webcast: http://public.viavid.com/index.php?id=138184
Replay Dial-In Numbers
Toll Free: 1-844-512-2921 Toll/International: 1-412-317-6671 Replay Pin Number: 13699345 Replay Start: Thursday, March 12, 2020, 11:30 AM ET Replay Expiry: Thursday, March 26, 2020, 11:59 PM ET
About Aramchol and Non-alcoholic Steatohepatitis (NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.
NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Our lead compound, Aramchol(TM), a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study.
Forward-Looking Statements:
his press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Galmed's objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Galmed intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause Galmed's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the timing and cost of Galmed's pivotal Phase 3 ARMOR trial, or the ARMOR Study; completion and receiving favorable results of the ARMOR Study for Aramchol or any other pre-clinical or clinical trial; regulatory action with respect to Aramchol by the FDA or the EMA; the commercial launch and future sales of Aramchol or any other future products or product candidates; Galmed's ability to comply with all applicable post-market regulatory requirements for Aramchol in the countries in which it seeks to market the product; Galmed's ability to achieve favorable pricing for Aramchol; Galmed's expectations regarding the commercial market for NASH patients; third-party payor reimbursement for Aramchol; Galmed's estimates regarding anticipated capital requirements and Galmed's needs for additional financing; market adoption of Aramchol by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol; the development and approval of the use of Aramchol for additional indications or in combination therapy; and Galmed's expectations regarding licensing, acquisitions and strategic operations. More detailed information about the risks and uncertainties affecting Galmed is contained under the heading "Risk Factors" included in Galmed's most recent Annual Report on Form 20-F filed with the SEC on March 12, 2020, and in other filings that Galmed has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed's current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
GALMED PHARMACEUTICALS LTD. Consolidated Balance Sheets (Audited) --- U.S. Dollars in thousands, except share data and per share data As of December 31, 2019 2018 Assets Current assets Cash and cash equivalents $ 15,931 $ 24,159 Restricted cash 112 Short-term deposits 27,938 6,067 Marketable debt securities 31,622 59,962 Other accounts receivable 827 218 Total current assets 76,430 90,406 Right of use assets 538 Property and equipment, net 171 194 Total non-current assets 709 194 Total assets $ 77,139 $ 90,600 Liabilities and stockholders' equity Current liabilities Trade payables $ 5,999 $ 1,814 Other accounts payable 935 892 Total current liabilities 6,934 2,706 Non-current liabilities Lease obligation $ 352 $ Total non-current liabilities 352 Stockholders' equity Ordinary shares, par value NIS 0.01 per share; Authorized 58 58 50,000,000 shares; Issued and outstanding: 21,139,385 shares as of December 31, 2019; 21,018,919 shares as of December 31, 2018 Additional paid-in capital 176,696 174,322 Accumulated other comprehensive income (loss) 35 (11) Accumulated deficit (106,936) (86,475) Total stockholders' equity 69,853 87,894 Total liabilities and stockholders' equity $ 77,139 $ 90,600
GALMED PHARMACEUTICALS LTD. Consolidated Statements of Operations (Audited) --- U.S. Dollars in thousands, except share data and per share data Year ended December 31, 2019 2018 2017 Revenue $ $ 2,038 $ 1,085 Research and development expenses 18,180 8,313 9,650 General and administrative expenses 4,196 4,440 3,799 Total operating loss 22,376 10,715 12,364 Financial income, net (1,915) (934) (65) Loss before income taxes 20,461 9,781 12,299 Income taxes 75 Net loss $ 20,461 $ 9,856 $ 12,299 Basic and diluted net loss per share $ 0.97 $ 0.54 $ 0.98 Weighted-average number of shares outstanding 21,114,399 18,137,689 12,487,349 used in computing basic and diluted net loss per share
GALMED PHARMACEUTICALS LTD. Consolidated Statements of Cash Flows (Audited) --- U.S. Dollars in thousands Year ended December 31, 2019 2018 2017 Cash flow from operating activities Net loss for the year $ (20,461) $ (9,856) $ (12,299) Adjustments required to reconcile net loss to net cash used in operating activities: Depreciation and amortization 35 387 239 Amortization of discount/premium on marketable debt securities (105) (144) 21 Loss (gain) on sale of marketable debt securities (9) 12 143 Linked difference of marketable debt securities (167) Interest income from short-term deposits (63) Stock-based compensation expense 2,231 1,783 1,394 Changes in operating assets and liabilities: Decrease in deferred revenue from collaboration agreement (538) (1,085) Decrease (increase) in other accounts receivable (609) (63) 129 Increase (decrease) in trade payables 4,185 (462) (846) Increase (decrease) in other accounts payable (141) (142) 671 Increase (decrease) in related party (267) Net cash used in operating activities (14,937) (9,023) (12,067) Cash flow from investing activities Purchase of property and equipment (12) (90) (12) Investment in securities, available for sale (72,600) (92,279) (3,869) Proceeds from sale of securities, available for sale 101,098 38,421 10,325 Investment in short-term deposits, net (21,808) (6,067) - Net cash provided by (used in) investing activities 6,678 (60,015) 6,444 Cash flow from financing activities Issuance of ordinary shares and warrants, net of issuance costs (*) 79,149 15,017 Proceeds from exercise of options 143 1,027 530 Net cash provided by financing activities 143 80,176 15,547 Increase (decrease) in cash and cash equivalents and restricted cash (8,116) 11,138 9,924 Cash and cash equivalents and restricted cash at the beginning of the year 24,159 13,021 3,097 Cash and cash equivalents and restricted cash at the end of the year $ 16,043 $ 24,159 $ 13,021 Supplemental disclosure of cash flow information: Cash received from interest $ 1,953 $ 865 $ 202 Cash paid for taxes $ $ 75 $ - Non-cash transactions: Recognition of right-of-use asset and lease liabilities from adoption of ASU 2016-02 $ 653 $ $
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SOURCE Galmed Pharmaceuticals Ltd.