Full Press Release Details
Conference call scheduled for 4:30 p.m. ET today
SAN DIEGO, March 13, 2019 -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced its financial results for the fourth quarter and year ended December 31, 2018, and provided an update on its clinical pipeline and other corporate developments.
Highlights from the Quarter, and Subsequent to December 31, 2018:
"The past year has been a transformative period for Viking, and we are excited to continue this momentum in 2019," stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "We were particularly pleased in 2018 to have presented positive Phase 2 data from our novel thyroid receptor beta agonist VK2809 in non-alcoholic fatty liver disease at the AASLD conference, and honored that these results were featured in the Best of AASLD conference highlights. We plan to present additional, new results from this study at the upcoming EASL conference in April, and remain on-track to file an IND to initiate a study in biopsy-confirmed NASH later this year. In addition, pre-IND work for our second thyroid receptor agonist VK0214 continues to progress, and we plan to file an IND to initiate clinical development by the end of the year. Thanks to successful fundraising efforts in 2018, we ended the year with more than $300 million on our balance sheet, and are now capitalized to reach major inflection points for multiple programs. Entering 2019, we are focused on executing our operating plans and enthusiastic about the future development of our pipeline."
Pipeline and Corporate Highlights
31st Annual ROTH Conference
Updated Time/Date: 12:00 p.m. PT on Monday, March 18, 2019 (webcast available)
Location: Ritz-Carlton Laguna Niguel, Dana Point, CA
Room: Pink - Salon 5
Oppenheimer's 29th Annual Healthcare Conference
Time/Date: 11:30 a.m. ET on Wednesday, March 20, 2019
Location: Westin New York Grand Central Hotel, New York
Room: Consulate Room
Q4 and Full-Year 2018 Financial Highlights
Fourth Quarter Ended December 31, 2018 and 2017
Research and development expenses for the three months ended December 31, 2018 were $5.1 million compared to $3.0 million for the same period in 2017. The increase was primarily due to increased pre-clinical study efforts, manufacturing expenses related to our drug candidates, use of third party consultants and stock-based compensation, partially offset by a decrease in clinical study expenses.
General and administrative expenses for the three months ended December 31, 2018 were $1.9 million compared to $1.4 million for the same period in 2017. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, and legal and patent expenses.
For the three months ended December 31, 2018, Viking reported a net loss of $5.2 million, or $0.07 per share, compared to a net loss of $4.1 million, or $0.14 per share, in the corresponding period in 2017. The increase in net loss for the three months ended December 31, 2018 was primarily due to the increase in research and development expenses noted previously, partially offset by an increase in other income related to the increase in interest income. The decrease in net loss per share for the three months ended December 31, 2018 is primarily driven by the additional shares outstanding at December 31, 2018 versus those outstanding at December 31, 2017, given the additional shares issued by the Company during 2018, primarily through public equity offerings.
Twelve Months Ended December 31, 2018 and 2017
Research and development expenses for the twelve months ended December 31, 2018 were $19.0 million compared to $13.7 million for the same period in 2017. The increase was primarily due to increased expenses related to pre-clinical study efforts, use of third
party consultants, stock-based compensation, and manufacturing related to our drug candidates, partially offset by a decrease in clinical study expenses.
General and administrative expenses for the twelve months ended December 31, 2018 were $7.1 million compared to $5.3 million for the same period in 2017. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, professional services, use of third party consultants, insurance, legal and patent expenses, and franchise taxes.
For the twelve months ended December 31, 2018, Viking reported a net loss of $22.1 million, or $0.38 per share, compared to a net loss of $20.6 million, or $0.79 per share, in the corresponding period in 2017. The increase in net loss for the twelve months ended December 31, 2018 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously offset by an increase in other income related to the decrease in the fair value of the debt conversion feature liability, as well as an increase in interest income. The decrease in net loss per share for the twelve months ended December 31, 2018 is primarily driven by the additional shares outstanding at December 31, 2018 versus those outstanding at December 31, 2017, given the additional shares issued by the Company during 2018, primarily through public equity offerings.
Balance Sheet as of December 31, 2018
At December 31, 2018, Viking held cash, cash equivalents and short-term investments totaling $301.5 million. As of February 28, 2019, Viking had 71,986,022 shares of common stock outstanding.
Management will host a conference call to discuss the company's fourth quarter and year-end 2018 financial results today at 4:30 pm Eastern. To participate on the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until March 20, 2019 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 10128574. Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Viking's website at www.vikingtherapeutics.com. An archive of the webcast will be available for 30 days on the company's website at www.vikingtherapeutics.com.
About Viking Therapeutics, Inc.
Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, orally available, first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. The company's clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, including non-alcoholic steatohepatitis (NASH). In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and
elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company is also developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of X-linked adrenoleukodystrophy (X-ALD).
Viking's other programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator. In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared with patients who received placebo. Other programs also include VK0612, a first-in-class, orally available drug candidate in Phase 2 development for the treatment of type 2 diabetes as well as two earlier-stage programs targeting metabolic diseases and anemia. The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
Follow Viking on Twitter @Viking_VKTX.
Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones, as well as the company's goals and plans regarding VK2809, VK5211 and VK0214 and their respective prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2809, VK5211, and VK0214; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2017, and our next Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law.
Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,089 | 3,033 | 19,040 | 13,741 | ||||||||||||
| General and administrative | 1,948 | 1,394 | 7,121 | 5,329 | ||||||||||||
| Total operating expenses | 7,037 | 4,427 | 26,161 | 19,070 | ||||||||||||
| Loss from operations | (7,037 | ) | (4,427 | ) | (26,161 | ) | (19,070 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of debt conversion feature liability | - | 633 | 1,398 | 345 | ||||||||||||
| Amortization of debt discount | - | (258 | ) | (404 | ) | (1,283 | ) | |||||||||
| Amortization of financing costs | (30 | ) | (34 | ) | (120 | ) | (571 | ) | ||||||||
| Interest income, net | 1,839 | 2 | 3,236 | 1 | ||||||||||||
| Realized loss on investments | (12 | ) | - | (12 | ) | - | ||||||||||
| Total other income (expense) | 1,797 | 343 | 4,098 | (1,508 | ) | |||||||||||
| Net loss | (5,240 | ) | (4,084 | ) | (22,063 | ) | (20,578 | ) | ||||||||
| Other comprehensive loss, net of tax: | ||||||||||||||||
| Unrealized loss on securities | (306 | ) | (16 | ) | (403 | ) | (13 | ) | ||||||||
| Comprehensive loss | $ | (5,546 | ) | $ | (4,100 | ) | $ | (22,466 | ) | $ | (20,591 | ) | ||||
| Basic and diluted net loss per share | $ | (0.07 | ) | $ | (0.14 | ) | $ | (0.38 | ) | $ | (0.79 | ) | ||||
| Weighted-average shares used to compute basic and diluted net loss per share | 71,340 | 29,872 | 57,580 | 25,978 |
Viking Therapeutics, Inc.
(In thousands, except share and per share amounts)
| December 31, 2018 (unaudited) | December 31, 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 24,779 | $ | 8,988 | ||||
| Short-term investments - available for sale | 276,741 | 11,587 | ||||||
| Prepaid clinical trial and preclinical study costs | 335 | 887 | ||||||
| Prepaid expenses and other current assets | 278 | 389 | ||||||
| Total current assets | 302,133 | 21,851 | ||||||
| Deferred public offering and other financing costs | 150 | 270 | ||||||
| Deposits | 29 | - | ||||||
| Total assets | $ | 302,312 | $ | 22,121 | ||||
| Liabilities, convertible notes and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 959 | $ | 1,529 | ||||
| Other accrued liabilities | 3,591 | 2,257 | ||||||
| Accrued interest | - | 22 | ||||||
| Convertible notes payable, current portion (net of discount of $0 and $404 at December 31, 2018 and 2017, respectively) | - | 3,451 | ||||||
| Debt conversion feature liability | - | 1,398 | ||||||
| Total current liabilities | 4,550 | 8,657 | ||||||
| Deferred rent | 12 | - | ||||||
| Total long-term liabilities | 12 | - | ||||||
| Total liabilities | 4,562 | 8,657 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.00001 par value: 10,000,000 shares authorized at December 31, 2018 and 2017; no shares issued and outstanding at December 31, 2018 and 2017 | - | - | ||||||
| Common stock, $0.00001 par value: 300,000,000 shares authorized at December 31, 2018 and 2017; 71,742,043 shares issued and outstanding at December 31, 2018 and 35,817,104 shares issued and outstanding at December 31, 2017 | 1 | - | ||||||
| Additional paid-in capital | 401,090 | 94,339 | ||||||
| Accumulated deficit | (102,918 | ) | (80,855 | ) | ||||
| Accumulated other comprehensive loss | (423 | ) | (20 | ) | ||||
| Total stockholders' equity | 297,750 | 13,464 | ||||||
| Total liabilities and stockholders' equity | $ | 302,312 | $ | 22,121 |
Vida Strategic Partners
Stephanie Diaz (Investors)