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Form 8-K Vanda Pharmaceuticals For: Aug 03

August 3, 2022 4:13 PM EDT

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 3, 2022
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware001-3418603-0491827
(State or other jurisdiction of incorporation)(Commission File No.)(IRS Employer Identification No.)
2200 Pennsylvania Avenue NW
Suite 300E
Washington, DC 20037
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (202) 734-3400
 
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading SymbolName of each exchange on which registered
Common Stock, par value $0.001 per shareVNDAThe Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company  
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨



Item 2.02.Results of Operations and Financial Condition.
On August 3, 2022, Vanda Pharmaceuticals Inc. (“Vanda”) issued a press release and is holding a conference call regarding its results of operations and financial condition for the quarter ended June 30, 2022. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Various statements to be made during the conference call are “forward-looking statements” under the securities laws, including, but not limited to, Vanda’s financial guidance for 2022, and statements regarding Vanda’s commercial products, plans and opportunities, as well as statements about Vanda’s products in development and the related clinical development and regulatory timelines and commercial potential for such products. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “project,” “target,” “goal,” “likely,” “will,” “would,” and “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances 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 the strength of its business in the U.S. and Vanda’s ability to complete the clinical development of, and obtain regulatory approval for, the products in its pipeline. Therefore, no assurance can be given 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. Forward-looking statements made during the call should be evaluated together with the various risks and uncertainties that affect Vanda’s business and market, particularly those identified in the “Cautionary Note Regarding Forward-Looking Statements”, “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, 2021, as updated by Vanda’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
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. The information contained in this Current Report on Form 8-K is intended to be considered in the context of Vanda’s filings with the SEC and other public announcements that Vanda makes, by press release or otherwise, from time to time. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information conveyed on the conference call will be provided only as of the date of the call, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements made during the call after the date thereof, whether as a result of new information, future events or otherwise, except as required by law.
The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01.Financial Statements and Exhibits.
 
(d)Exhibits

Exhibit No.  Description
99.1 
104Cover Page Interactive Data File (embedded within the Inline XBRL document).



SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated:August 3, 2022 VANDA PHARMACEUTICALS INC.
 By: /s/ Timothy Williams
 Name: Timothy Williams
 Title: Senior Vice President, General Counsel and Secretary


Exhibit 99.1
 vandaq32019earningsca_imaga.jpg
Vanda Pharmaceuticals Reports Second Quarter 2022 Financial Results
 
Q2 2022 total revenues were $64.4 million
Total revenues in the first six months of 2022 were $124.6 million
Vanda provides update on pipeline advancements and upcoming milestones
WASHINGTON – August 3, 2022 /PRNewswire/ – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2022.
“During the second quarter we made significant progress towards commercializing our products and improving access to HETLIOZ® for patients with Non-24,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. “We advanced our clinical pipeline, with significant clinical milestones expected in the coming quarters, and we are preparing our NDA for tradipitant in gastroparesis and our sNDA for HETLIOZ® in insomnia.”
Financial Highlights
Second Quarter of 2022 
Total net product sales from HETLIOZ® and Fanapt® were $64.4 million in the second quarter of 2022, a 5% decrease compared to $67.9 million in the second quarter of 2021.
 
HETLIOZ® net product sales were $41.2 million in the second quarter of 2022, a 7% decrease compared to $44.5 million in the second quarter of 2021, due in part to continued reimbursement challenges for prescriptions for patients with Non-24.

Fanapt® net product sales were $23.2 million in the second quarter of 2022, a 1% decrease compared to $23.4 million in the second quarter of 2021.

Net income was $2.6 million in the second quarter of 2022 compared to $9.7 million in the second quarter of 2021.
First Six Months of 2022
Total net product sales from HETLIOZ® and Fanapt® were $124.6 million in the first six months of 2022, a 5% decrease compared to $130.6 million in the first six months of 2021.
 
HETLIOZ® net product sales were $78.2 million in the first six months of 2022, a 7% decrease compared to $83.9 million in the first six months of 2021, due in part to continued reimbursement challenges for prescriptions for patients with Non-24.

Fanapt® net product sales were $46.4 million in the first six months of 2022, a 1% decrease compared to $46.7 million in the first six months of 2021.

Net loss was $3.9 million in the first six months of 2022 compared to net income of $18.3 million in the first six months of 2021.

Cash, cash equivalents and marketable securities (Cash) was $440.9 million as of June 30, 2022, representing an increase to Cash of $44.4 million compared to June 30, 2021.




Key Operational Highlights
HETLIOZ® (tasimelteon)
Clinical trials for HETLIOZ® in delayed sleep phase disorder (DSPD) and sleep disturbances in autism spectrum disorder (ASD) are currently enrolling patients.
Vanda is preparing for the submission of a supplemental New Drug Application (sNDA) for HETLIOZ® in the treatment of insomnia.
Since November 2021, more than 15 states have revised or agreed to revise their Medicaid prior authorization criteria to broaden access to HETLIOZ® for patients with Non-24 and patients with nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).
In July 2022, an Administrative Law Judge struck down a Medicare Part D plan policy that blocked HETLIOZ® coverage for sighted Non-24 patients. Vanda intends to advocate with other Part D plans to challenge similar policies and improve HETLIOZ® access for Non-24 patients.
In January 2022, Vanda settled its HETLIOZ® patent litigation against one of the Abbreviated New Drug Application (ANDA) defendants. The trial for the consolidated lawsuit against the remaining defendants was held in March 2022. A decision is expected from the court by the end of 2022.
Tradipitant
Vanda is continuing to conduct an open-label safety study for tradipitant in gastroparesis and continues to receive requests from patients seeking access to tradipitant through the Expanded Access program that has multiple patients who have taken tradipitant for more than a year.
Vanda recently held a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned New Drug Application (NDA) submission for tradipitant in the short-term treatment of nausea in gastroparesis. Vanda is preparing for the submission of the NDA for this indication.
The Phase III study of tradipitant in the treatment of motion sickness is approximately 30% enrolled.
Fanapt® (iloperidone)
Enrollment of the Phase III clinical study of Fanapt® in acute manic episodes in patients with bipolar disorder is close to being fully enrolled. The study is a placebo controlled four-week evaluation of approximately 400 patients at sites in the U.S. and Europe. Results are expected by the end of 2022.
VQW-765
The Phase II clinical study of a single-dose treatment of VQW-765 to alleviate social/performance anxiety is fully enrolled. Results are expected by the end of 2022.
GAAP Financial Results
Net income was $2.6 million in the second quarter of 2022 compared to net income of $9.7 million in the second quarter of 2021. Diluted net income per share was $0.05 in the second quarter of 2022 compared to diluted net income per share of $0.17 in the second quarter of 2021.
Net loss was $3.9 million in the first six months of 2022 compared to net income of $18.3 million in the first six months of 2021. Diluted net loss per share was $0.07 in the first six months of 2022 compared to diluted net income per share of $0.32 in the first six months of 2021.



2022 Financial Guidance
Vanda expects to achieve the following financial objectives in 2022:

Full Year 2022
Financial Objectives
Full Year 2022
Guidance
Total revenues$240 to $280 million
HETLIOZ® net product sales
$150 to $180 million
Fanapt® net product sales
$90 to $100 million
Year-end 2022 Cash
Greater than $440 million

Conference Call
Vanda has scheduled a conference call for today, Wednesday, August 3, 2022, at 4:30 PM ET. During the call, Vanda’s management will discuss the second quarter 2022 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 4304469. A replay of the call will be available on Wednesday, August 3, 2022, beginning at 8:30 PM ET and will be accessible until Wednesday, August 10, 2022 at 8:30 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 4304469.
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.
Vanda is a leading 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 and follow us on Twitter @vandapharma.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not limited to, the guidance provided under “2022 Financial Guidance” above and statements regarding Vanda’s plans for pursuit of regulatory approval of tradipitant in the treatment of gastroparesis and HETLIOZ® in the treatment of insomnia, Vanda’s strategy for improving access to HETLIOZ® for all Non-24 patients, the timing of the court’s decision with respect to the Company’s HETLIOZ® patent litigation, and the clinical development timelines for Fanapt® and VQW-765 are “forward-looking statements” under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances 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 the strength of its business in the U.S., the FDA’s assessment of the sufficiency of the data packages to be included in Vanda’s planned NDA and sNDA submissions for tradipitant and HETLIOZ®, Vanda’s ability to fully enroll and complete the Phase III clinical study of Fanapt® in bipolar disorder and Vanda’s ability to complete the Phase II clinical study of VQW-765 in social/performance anxiety. Therefore, no assurance can be given that the 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. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda’s business and market, particularly those identified in the “Cautionary Note Regarding Forward-Looking Statements”, “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, 2021, as updated by Vanda’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
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 press release is provided only as of the date of this press 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, except as required by law.



VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except for share and per share amounts)
(unaudited)
 
 Three Months EndedSix Months Ended
 June 30
2022
June 30
2021
June 30
2022
June 30
2021
Revenues:
HETLIOZ® net product sales
$41,188 $44,509 $78,219 $83,852 
Fanapt® net product sales
23,202 23,390 46,363 46,716 
Total revenues64,390 67,899 124,582 130,568 
Operating expenses:
Cost of goods sold excluding amortization6,059 6,566 11,724 12,596 
Research and development21,490 20,248 42,459 36,379 
Selling, general and administrative33,001 28,347 73,849 58,144 
Intangible asset amortization379 369 758 739 
Total operating expenses60,929 55,530 128,790 107,858 
Income (loss) from operations3,461 12,369 (4,208)22,710 
Other income329 235 434 322 
Income (loss) before income taxes3,790 12,604 (3,774)23,032 
Provision for income taxes1,216 2,951 82 4,729 
Net income (loss)$2,574 $9,653 $(3,856)$18,303 

Net income (loss) per share, basic
$0.05 $0.17 $(0.07)$0.33 
Net income (loss) per share, diluted$0.05 $0.17 $(0.07)$0.32 

Weighted average shares outstanding, basic
56,508,533 55,582,916 56,307,999 55,365,558 
Weighted average shares outstanding, diluted56,821,024 56,903,340 56,307,999 56,705,419 



VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
 
June 30
2022
December 31
2021
ASSETS
Current assets:
Cash and cash equivalents$58,226 $52,071 
Marketable securities382,632 380,742 
Accounts receivable, net28,805 32,467 
Inventory1,496 1,025 
Prepaid expenses and other current assets25,736 11,996 
Total current assets496,895 478,301 
Property and equipment, net2,746 3,113 
Operating lease right-of-use assets8,603 9,272 
Intangible assets, net19,323 20,081 
Deferred tax assets72,687 74,878 
Non-current inventory and other8,848 8,147 
Total assets$609,102 $593,792 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities$50,236 $34,438 
Product revenue allowances38,164 39,981 
Total current liabilities88,400 74,419 
Operating lease non-current liabilities9,286 10,055 
Other non-current liabilities2,867 4,390 
Total liabilities100,553 88,864 
Stockholders’ equity:
Common stock57 56 
Additional paid-in capital
677,955 669,223 
Accumulated other comprehensive loss(1,431)(175)
Accumulated deficit(168,032)(164,176)
Total stockholders’ equity508,549 504,928 
Total liabilities and stockholders’ equity$609,102 $593,792 




Corporate Contact:

Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com

Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
SOURCE Vanda Pharmaceuticals Inc.



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