Total net product sales from HETLIOZ and Fanapt were $41.3M in the third quarter of 2017, a 2% decrease compared to $42.1M in the second quarter of 2017 and a 7% increase compared to $38.5M in the third quarter of 2016.
-- Total net product sales were $41.3 million in the third quarter of 2017
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| [07-November-2017] |
| WASHINGTON, Nov. 7, 2017 /PRNewswire/ -- Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) today announced financial and operational results for the third quarter ended September 30, 2017. “During the third quarter of 2017, Vanda demonstrated the importance of the diverse set of ongoing initiatives to advance our growth strategy,” said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. “The tradipitant results in atopic dermatitis, early trends from the HETLIOZ to psychiatrists initiative and the resolution of the HETLIOZ pricing negotiation in Germany, all represent significant potential drivers of growth.” Key Highlights:
HETLIOZ® (tasimelteon)
Fanapt® (iloperidone)
Research and Development Tradipitant
HETLIOZ®
VTR-297 (histone deactetylase (HDAC) inhibitor)
Cash, cash equivalents and marketable securities (Cash) were $139.9 million as of September 30, 2017, representing an increase to Cash of $2.8 million during the third quarter of 2017. Non-GAAP Financial Results For the third quarter of 2017, Non-GAAP net loss was $1.3 million, or $0.03 per share, compared to a Non-GAAP net income of $4.6 million, or $0.11 per share, for the third quarter of 2016. Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled “Non-GAAP Financial Information” and “Reconciliation of GAAP to Non-GAAP Financial Information.” 2017 Financial Guidance Vanda is updating its 2017 financial guidance and expects to achieve the following financial objectives in 2017: Fourth Quarter 2017 Fourth Quarter Financial Objectives 2017 Guidance --- -------- Combined net product sales from both HETLIOZ(R) and Fanapt(R) $42 to $48 million ------------------------------------------------------------ ------------------ HETLIOZ(R) net product sales $24 to $27 million ---------------------------- ------------------ Fanapt(R) net product sales $18 to $21 million --------------------------- ------------------ Full Year 2017 Revised Full Year Prior Full Year Financial Objectives 2017 2017 Guidance Guidance --- -------- -------- Combined net product sales from both HETLIOZ(R) and Fanapt(R) $163 to $169 million $165 to $175 million ------------------------------------------------------------ ------------------- -------------------- HETLIOZ(R) net product sales $89 to $92 million $88 to $93 million ---------------------------- ------------------ ------------------ Fanapt(R) net product sales $74 to $77 million $77 to $82 million --------------------------- ------------------ ------------------ Non-GAAP Operating expenses, excluding Cost of goods sold(1) $150 to $157 million $162 to $172 million ----------------------------------------------------------- ------------------- -------------------- Intangible asset amortization $1.7 million $1.7 million ----------------------------- ------------ ------------ Stock-based compensation $9 to $12 million $9 to $12 million ------------------------ ----------------- ----------------- Year-end 2017 Cash $131 to $141 million $121 to $141 million ------------------ ------------------- -------------------- (1) Non-GAAP Operating expenses, excludes cost of goods sold, intangible asset amortization and stock-based compensation.
Conference Call Vanda has scheduled a conference call for today, Tuesday, November 7, 2017, at 4:30 PM ET. During the call, Vanda’s management will discuss the third quarter 2017 financial results and other corporate activities. Investors can call 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 45886211. A replay of the call will be available on Tuesday, November 7, 2017, beginning at 7:00 PM ET and will be accessible until Tuesday, November 14, 2017, at 11:59 PM ET. The replay call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers. The passcode number is 45886211. The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investor Relations 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. Non-GAAP Financial Information Vanda believes that the Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda’s business and reflect how it manages the business internally and sets operational goals. Vanda’s “Non-GAAP Selling, general and administrative expenses” and “Non-GAAP Research and development expenses” exclude stock-based compensation. Vanda’s “Non-GAAP Net income (loss),” “Non-GAAP Net income (loss) per share” and “Non-GAAP Operating expenses excluding Cost of goods sold” exclude stock-based compensation and intangible asset amortization. Vanda believes that excluding the impact of these items better reflects the recurring economic characteristics of its business, as well as Vanda’s use of financial resources and its long-term performance. This press release includes a projection of 2017 Non-GAAP Operating expenses, excluding Cost of goods sold, a forward-looking Non-GAAP financial measure under the heading “2017 Financial Guidance.” This Non-GAAP financial measure is determined by excluding cost of goods sold, stock-based compensation and intangible asset amortization. Vanda is unable to reconcile this Non-GAAP guidance to GAAP because it is difficult to predict the future impact of these adjustments. These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies since not all companies may calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies. The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda’s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial guidance in connection with its GAAP guidance. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure. About Vanda Pharmaceuticals Inc. Vanda is a 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 www.vandapharma.com. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this release, including, but not limited to, the guidance provided under “2017 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. through the HETLIOZ® to Psychiatrists Initiative, among other means, Vanda’s ability to complete the clinical development and obtain regulatory approval of tradipitant for the treatment of atopic dermatitis, Vanda’s ability to successfully commercialize HETLIOZ® in Europe 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, 2016 and quarterly report on Form 10-Q for the fiscal quarter ended June 30, 2017, 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 fiscal quarter ended September 30, 2017, to be filed with the SEC in the fourth quarter of 2017. 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) (unaudited) Three Months Ended Nine Months Ended ------------------ ----------------- September 30 September 30 September 30 September 30 2017 2016 2017 2016 ---- ---- ---- ---- Revenues: HETLIOZ(R)product sales, net $22,279 $18,715 $64,968 $52,376 Fanapt(R)product sales, net 19,057 19,767 55,839 55,397 Total revenues 41,336 38,482 120,807 107,773 Operating expenses: Cost of goods sold excluding amortization 4,525 6,990 13,057 19,440 Research and development 10,178 7,294 28,393 21,542 Selling, general and administrative 31,124 21,908 92,792 75,880 Intangible asset amortization 432 2,943 1,318 8,828 Total operating expenses 46,259 39,135 135,560 125,690 ------ ------ ------- ------- Loss from operations (4,923) (653) (14,753) (17,917) Other income 396 223 1,073 511 Loss before income taxes (4,527) (430) (13,680) (17,406) Provision for income taxes 23 - 49 - Net loss $(4,550) $(430) $(13,729) $(17,406) ======= ===== ======== ======== Net loss per share, basic and diluted $(0.10) $(0.01) $(0.31) $(0.40) Weighted average shares outstanding, basic and diluted 44,885,287 43,515,404 44,669,201 43,275,074
VANDA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) September 30 December 31 2017 2016 ---- ---- ASSETS Current assets: Cash and cash equivalents $22,586 $40,426 Marketable securities 117,295 100,914 Accounts receivable, net 18,179 20,268 Inventory 921 779 Prepaid expenses and other current assets 10,738 11,788 ------ ------ Total current assets 169,719 174,175 Property and equipment, net 5,448 5,015 Intangible assets, net 26,501 27,819 Non-current inventory and other 4,038 3,365 Total assets $205,706 $210,374 ======== ======== LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable and accrued liabilities $18,921 $16,196 Accrued government and other rebates 25,615 34,124 Milestone obligations under license agreements 27,000 - Total current liabilities 71,536 50,320 Milestone obligation under license agreement - 25,000 Other non- current liabilities 3,701 3,724 Total liabilities 75,237 79,044 Stockholders’ equity: Common stock 45 44 Additional paid- in capital 489,939 477,087 Accumulated other comprehensive income 73 58 Accumulated deficit (359,588) (345,859) Total stockholders’ equity 130,469 131,330 ------- ------- Total liabilities and stockholders’ equity $205,706 $210,374 ======== ========
VANDA PHARMACEUTICALS INC. Reconciliation of GAAP to Non-GAAP Financial Information (in thousands, except for share and per share amounts) (unaudited) Three Months Ended Nine Months Ended ------------------ ----------------- September 30 September 30 September 30 September 30 2017 2016 2017 2016 ---- ---- ---- ---- Net loss $(4,550) $(430) $(13,729) $(17,406) Adjustments: Stock-based compensation 2,771 2,100 7,683 6,440 Intangible asset amortization 432 2,943 1,318 8,828 Non-GAAP Net income (loss) $(1,347) $4,613 $(4,728) $(2,138) ======= ====== ======= ======= Non-GAAP Net income (loss) per share, basic $(0.03) $0.11 $(0.11) $(0.05) Weighted average shares outstanding, basic 44,885,287 43,515,404 44,669,201 43,275,074 Operating expenses $46,259 $39,135 $135,560 $125,690 Adjustments: Cost of goods sold excluding amortization (4,525) (6,990) (13,057) (19,440) Stock-based compensation (2,771) (2,100) (7,683) (6,440) Intangible asset amortization (432) (2,943) (1,318) (8,828) Non-GAAP Operating expenses excluding Cost of goods sold $38,531 $27,102 $113,502 $90,982 Research and development $10,178 $7,294 $28,393 $21,542 Adjustment: Stock-based compensation (264) (539) (958) (1,552) Non-GAAP Research and development $9,914 $6,755 $27,435 $19,990 ====== ====== ======= ======= Selling, general and administrative $31,124 $21,908 $92,792 $75,880 Adjustment: Stock-based compensation (2,507) (1,561) (6,725) (4,888) Non-GAAP Selling, general and administrative $28,617 $20,347 $86,067 $70,992 ======= ======= ======= =======
COMPANY CONTACT: View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-third-quarter-2017-financial-results-300551228.html SOURCE Vanda Pharmaceuticals Inc. | ||
Company Codes: NASDAQ-NMS:VNDA |
