Full Press Release Details
Vanda Pharmaceuticals Reports Third Quarter 2019 Financial Results
WASHINGTON November 6, 2019 Vanda Pharmaceuticals Inc. (Vanda)
(Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2019.
These results affirm
Vanda s corporate strategy, and continue to demonstrate our ability to grow our commercial assets and expand our pipeline of products, said Mihael H. Polymeropoulos, M.D., Vanda s President and CEO. I am proud of the progress
we have made in our research and development programs, with several new filings expected to be submitted within the next two years. Furthermore, Vanda has put in place a proactive regulatory strategy to better support our patients and
Key Financial Highlights:
Key Research and Development Highlights:
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
VTR-297 (histone deactetylase
Corporate Highlights:
GAAP Financial Results
$100.4 million for the third quarter of 2019, or $1.88 per share, compared to net income of $7.2 million, or $0.14 per share, for the third quarter of 2018.
The income tax benefit of $88.1 million reflected in the financial results for the third quarter of 2019 includes the favorable impact of the release of
Vanda s deferred tax asset valuation allowance.
Income before income taxes was $12.3 million in the third quarter of 2019, a 69% increase
compared to $7.3 million in the third quarter of 2018.
2019 Financial Guidance
Vanda reiterates its 2019 net product sales guidance and expects results in the upper half of the range. In addition, Vanda provides an update to Year-end 2019 Cash and expects to achieve the following financial objectives in 2019:
| Full Year 2019 Financial Objectives | Full Year 2019 Guidance | |
| Combined net product sales from both HETLIOZ and Fanapt | $215 to $225 million 1 | |
| HETLIOZ net product sales | $137 to $143 million 1 | |
| Fanapt net product sales | $78 to $82 million 1 | |
| Year-end 2019 Cash | Greater than $295 million as compared to prior guidance of Greater than $275 million |
Vanda has scheduled a conference call
for today, Wednesday, November 6, 2019, at 4:30 PM ET. During the call, Vanda s management will discuss the third quarter 2019 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816
(international) and use passcode 5377942. A replay of the call will be available on Wednesday, November 6, 2019, beginning at 7:30 PM ET and will be accessible until Wednesday, November 13, 2019, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5377942.
The conference call will be broadcast simultaneously on Vanda s website, www.vandapharma.com. Investors should click on the Investors tab and are
advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda s website for a period of 30 days.
About Vanda Pharmaceuticals Inc.
global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, but not limited to, the guidance provided under 2019 Financial Guidance above, are
forward-looking statements under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual
results to differ materially from those reflected in Vanda s forward-looking statements include, among others, Vanda s assumptions regarding its ability to continue to grow its business in the U.S., Vanda s ability to complete the
clinical development and obtain regulatory approval of tradipitant for the treatment of motion sickness, gastroparesis and/or chronic pruritus in atopic dermatitis, the outcome of the lawsuit initiated by Vanda against the FDA relating to
tradipitant, Vanda s discussion and potential resolution of the deficiencies that the FDA believes are contained in the sNDA for HETLIOZ for the treatment of Jet Lag Disorder and
Vanda s ability to obtain marketing approval for the use of HETLIOZ in the treatment of Jet Lag Disorder following any such resolution, Vanda s ability to complete the clinical
development, submit an sNDA and obtain regulatory approval of tasimelteon for the treatment of sleep disorders in patients with Smith-Magenis Syndrome and other factors that are described in the Risk Factors and Management s
Discussion and Analysis of Financial Condition and Results of Operations sections of Vanda s annual report on Form 10-K for the fiscal year ended December 31, 2018 and quarterly report on Form 10-Q for the quarter ended June 30, 2019, which are on file with the SEC and available on the SEC s website at www.sec.gov. Additional factors may be described in those sections of Vanda s
quarterly report on Form 10-Q for the quarter ended September 30, 2019, to be filed with the SEC in the fourth quarter of 2019. In addition to the risks described above and in Vanda s annual report
on Form 10-K and quarterly reports on Form 10-Q, other unknown or unpredictable factors also could affect Vanda s results. There can be no assurance that the actual
results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such
forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Vanda or any person acting
on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The
information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new
information, future events or otherwise.
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except for share and per share amounts)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30 | September 30 | September 30 | September 30 | |||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product sales, net | $ | 37,589 | $ | 29,923 | $ | 104,381 | $ | 83,391 | ||||||||
| Fanapt product sales, net | 21,896 | 19,212 | 61,877 | 56,686 | ||||||||||||
| Total revenues | 59,485 | 49,135 | 166,258 | 140,077 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold excluding amortization | 6,782 | 5,068 | 18,263 | 14,841 | ||||||||||||
| Research and development | 11,347 | 11,390 | 35,575 | 30,672 | ||||||||||||
| Selling, general and administrative | 30,221 | 26,047 | 92,718 | 80,829 | ||||||||||||
| Intangible asset amortization | 376 | 397 | 1,135 | 1,147 | ||||||||||||
| Total operating expenses | 48,726 | 42,902 | 147,691 | 127,489 | ||||||||||||
| Income from operations | 10,759 | 6,233 | 18,567 | 12,588 | ||||||||||||
| Other income | 1,517 | 1,030 | 4,651 | 2,440 | ||||||||||||
| Income before income taxes | 12,276 | 7,263 | 23,218 | 15,028 | ||||||||||||
| Provision (benefit) for income taxes | (88,147 | ) | 92 | (88,119 | ) | 180 | ||||||||||
| Net income | $ | 100,423 | $ | 7,171 | $ | 111,337 | $ | 14,848 | ||||||||
| Net income per share, basic | $ | 1.88 | $ | 0.14 | $ | 2.10 | $ | 0.30 | ||||||||
| Net income per share, diluted | $ | 1.84 | $ | 0.13 | $ | 2.03 | $ | 0.28 | ||||||||
| Weighted average shares outstanding, basic | 53,297,298 | 52,389,012 | 53,052,521 | 50,321,640 | ||||||||||||
| Weighted average shares outstanding, diluted | 54,541,625 | 54,709,749 | 54,803,851 | 52,315,642 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30 2019 (1) | December 31 2018 (1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 39,208 | $ | 61,005 | ||||
| Marketable securities | 198,577 | 196,355 | ||||||
| Accounts receivable, net | 26,824 | 28,780 | ||||||
| Inventory | 1,019 | 994 | ||||||
| Prepaid expenses and other current assets | 14,382 | 11,998 | ||||||
| Total current assets | 280,010 | 299,132 | ||||||
| Marketable securities, non-current | 61,827 | |||||||
| Property and equipment, net | 4,156 | 4,417 | ||||||
| Operating lease right-of-use assets | 11,436 | |||||||
| Intangible assets, net | 23,407 | 24,542 | ||||||
| Deferred tax assets | 89,072 | |||||||
| Non-current inventory and other | 4,541 | 4,039 | ||||||
| Total assets | $ | 474,449 | $ | 332,130 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 26,992 | $ | 21,584 | ||||
| Product revenue allowances | 33,004 | 31,231 | ||||||
| Milestone obligations under license agreements | 200 | |||||||
| Total current liabilities | 59,996 | 53,015 | ||||||
| Operating lease non-current liabilities | 12,793 | |||||||
| Other non-current liabilities | 753 | 3,693 | ||||||
| Total liabilities | 73,542 | 56,708 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 53 | 52 | ||||||
| Additional paid-in capital | 625,524 | 611,587 | ||||||
| Accumulated other comprehensive income | 211 | 1 | ||||||
| Accumulated deficit | (224,881 | ) | (336,218 | ) | ||||
| Total stockholders equity | 400,907 | 275,422 | ||||||
| Total liabilities and stockholders equity | $ | 474,449 | $ | 332,130 |
Chief Corporate Affairs and Communications Officer
Vanda Pharmaceuticals Inc.
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals Inc.