Full Press Release Details
Vanda Pharmaceuticals Reports Third Quarter 2021 Financial Results
Q3 2021 total revenues were $70.1 million, a 16% increase compared to Q3 2020
Total revenues for the first nine months of 2021 were $200.7 million, an 11% increase compared to the first nine months of 2020
Enrollment of the Phase III clinical study of tradipitant in gastroparesis is complete and results are expected by the end of 2021
WASHINGTON - November 3, 2021 PRNewswire - Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq VNDA) today announced financial and operational results for the third quarter ended September 30, 2021.
"Vanda is approaching another pivotal moment in its 18-year history with the upcoming completion of the Phase III study of tradipitant in gastroparesis and anticipated results by the end of this year. We believe that tradipitant has the potential to become the first new product in 40 years for the treatment of gastroparesis, a serious and debilitating disorder that severely impacts the lives of many people. Additionally, the launch of HETLIOZ and HETLIOZ LQ for nighttime sleep disturbances in people with Smith-Magenis Syndrome is progressing well as we are beginning our broad awareness campaign. Across all of our programs, patient access to innovative treatments remains a key goal of Vanda. We are currently working to address the escalating reimbursement delays for HETLIOZ , which are especially impacting Non-24 patients with light perception, and we are confident in our ability to drive positive outcomes for patients. I am proud of the Vanda team for continuing to advance Vanda's innovation objectives and creating value for patients and all of the company's stakeholders," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.
Financial Highlights
Third Quarter of 2021
Total net product sales from HETLIOZ and Fanapt were $70.1 million in the third quarter of 2021, a 16% increase compared to $60.3 million in the third quarter of 2020.
HETLIOZ net product sales were $45.6 million in the third quarter of 2021, a 15% increase compared to $39.6 million in the third quarter of 2020.
Fanapt net product sales were $24.5 million in the third quarter of 2021, an 18% increase compared to $20.7 million in the third quarter of 2020.
Income before taxes was $10.7 million in the third quarter of 2021 compared to $8.4 million in the third quarter of 2020.
First Nine Months of 2021
Total net product sales from HETLIOZ and Fanapt were $200.7 million in the first nine months of 2021, an 11% increase compared to $180.5 million in the first nine months of 2020.
HETLIOZ net product sales were $129.5 million in the first nine months of 2021, an 11% increase compared to $116.5 million in the first nine months of 2020.
Fanapt net product sales were $71.2 million in the first nine months of 2021, an 11% increase compared to $64.0 million in the first nine months of 2020.
Income before taxes was $33.8 million in the first nine months of 2021 compared to $20.7 million in the first nine months of 2020.
Cash, cash equivalents and marketable securities (Cash) was $406.0 million as of September 30, 2021, representing an increase to Cash of $57.4 million compared to September 30, 2020.
| Third Quarter | ||||||||||||||
| (in thousands) | September 30 2021 | September 30 2020 | $ Change | % Change | ||||||||||
| HETLIOZ net product sales | $ | 45,615 | $ | 39,618 | $ | 5,997 | 15 | % | ||||||
| Fanapt net product sales | 24,480 | 20,690 | 3,790 | 18 | % | |||||||||
| Total revenues | $ | 70,095 | $ | 60,308 | $ | 9,787 | 16 | % |
| First Nine Months | ||||||||||||||
| (in thousands) | September 30 2021 | September 30 2020 | $ Change | % Change | ||||||||||
| HETLIOZ net product sales | $ | 129,467 | $ | 116,515 | $ | 12,952 | 11 | % | ||||||
| Fanapt net product sales | 71,196 | 64,000 | 7,196 | 11 | % | |||||||||
| Total revenues | $ | 200,663 | $ | 180,515 | $ | 20,148 | 11 | % |
Key Operational Highlights
Enrollment of the randomized portion of the Phase III clinical study of tradipitant in gastroparesis is complete. The randomized portion of the study is a 12-week study of approximately 200 patients with idiopathic or diabetic gastroparesis. Results are expected by the end of 2021. Enrollment of the open label portion of the study is ongoing with more than 250 patients enrolled.
HETLIOZ (tasimelteon)
Reimbursement challenges with HETLIOZ prescriptions for patients with Non-24 have increased significantly. While Vanda is working to address these challenges and is confident in its ability to successfully navigate the current environment, Vanda is revising its HETLIOZ net product sales guidance to $170 to $190 million from the prior HETLIOZ net product sales guidance of $180 to $200 million.
In December 2020, the FDA approved HETLIOZ capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).1 To date, more than 90 patients with SMS have been prescribed HETLIOZ or HETLIOZ LQ and a broad awareness campaign is expected to begin during the fourth quarter of 2021.
A Phase III clinical study of HETLIOZ in delayed sleep phase disorder (DSPD) is currently enrolling patients. The study has a 28-day randomized evaluation period and plans to enroll approximately 300 patients. DSPD is likely the most prevalent circadian-rhythm sleep disorder, affecting approximately 1% of the population, and there is no FDA approved treatment at this time.2
Fanapt (iloperidone)
A Phase III clinical study of Fanapt in acute bipolar mania disorder is currently enrolling. The study is a placebo controlled four-week evaluation of approximately 400 patients at sites in the U.S. and Europe.
A repeat-dose clinical pharmacology study of the long acting injectable (LAI) formulation of Fanapt is ongoing. A Phase III study of the LAI formulation for the treatment of acute schizophrenia is planned to follow the pharmacology study.
Evaluation of P88, the active metabolite of iloperidone, has been initiated. P88 has the potential to improve the clinical profile of Fanapt and create sustained, long-term value in the treatment of psychiatric disorders.
GAAP Financial Results
Income before taxes was $10.7 million in the third quarter of 2021 compared to $8.4 million in the third quarter of 2020. Net income was $7.8 million in the third quarter of 2021 compared to net income of $5.9 million in the third quarter of 2020. Diluted net income per share was $0.14 in the third quarter of 2021 compared to diluted net income per share of $0.11 in the third quarter of 2020.
Income before taxes was $33.8 million in the first nine months of 2021 compared to $20.7 million in the first nine months of 2020. Net income was $26.1 million in the first nine months of 2021 compared to net income of $15.1 million in the first nine months of 2020. Diluted net income per share was $0.46 in the first nine months of 2021 compared to diluted net income per share of $0.28 in the first nine months of 2020.
2021 Financial Guidance
Vanda is updating its 2021 financial guidance and expects to achieve the following financial objectives in 2021
| Full Year 2021 Financial Objectives | Revised Full Year 2021 Guidance | Prior Full Year 2021 Guidance |
| Total revenues | $260 to $290 million | $270 to $300 million |
| HETLIOZ net product sales | $170 to $190 million | $180 to $200 million |
| Fanapt net product sales | $90 to $100 million | $90 to $100 million |
| Year-end 2021 Cash | Greater than $400 million | Greater than $400 million |
Vanda has scheduled a conference call for today, Wednesday, November 3, 2021, at 4 30 PM ET. During the call, Vanda's management will discuss the third quarter 2021 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5961858. A replay of the call will be available on Wednesday, November 3, 2021, beginning at 7 30 PM ET and will be accessible until Wednesday, November 10, 2021 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 5961858.
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.
1.Refer to Company press release titled FDA Approves HETLIOZ (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome issued on December 1, 2020. https vandapharmaceuticalsinc.gcs-web.com node 14306 pdf
2.P.J. Murphy, Delayed Sleep-Phase Type, Encyclopedia of Sleep, Academic Press, 2013, Pages 22-25, ISBN 9780123786111, https doi.org 10.1016 B978-0-12-378610-4.00268-0
About Vanda Pharmaceuticals Inc.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not limited to, the guidance provided under "2021 Financial Guidance" above and statements regarding the clinical development timelines for tradipitant and Fanapt LAI, the therapeutic and commercial potential of tradipitant and P88, and Vanda's ability to address reimbursement challenges 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 its ability to continue to grow its business in the U.S., Vanda's ability to complete the clinical development for tradipitant in the treatment of gastroparesis and Fanapt LAI in the treatment of acute schizophrenia, Vanda's ability to obtain regulatory approval of tradipitant in the treatment of gastroparesis, the ability of P88 to improve the clinical profile of Fanapt , and Vanda's ability to improve patient access to HETLIOZ . 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, 2020, 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)
| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30 2021 | September 30 2020 | September 30 2021 | September 30 2020 | ||||||||||||
| Revenues | |||||||||||||||
| HETLIOZ net product sales | $ | 45,615 | $ | 39,618 | $ | 129,467 | $ | 116,515 | |||||||
| Fanapt net product sales | 24,480 | 20,690 | 71,196 | 64,000 | |||||||||||
| Total revenues | 70,095 | 60,308 | 200,663 | 180,515 | |||||||||||
| Operating expenses | |||||||||||||||
| Cost of goods sold excluding amortization | 6,797 | 5,898 | 19,393 | 16,952 | |||||||||||
| Research and development | 19,653 | 12,298 | 56,032 | 40,728 | |||||||||||
| Selling, general and administrative | 32,456 | 34,001 | 90,600 | 104,939 | |||||||||||
| Intangible asset amortization | 370 | 369 | 1,109 | 1,108 | |||||||||||
| Total operating expenses | 59,276 | 52,566 | 167,134 | 163,727 | |||||||||||
| Income from operations | 10,819 | 7,742 | 33,529 | 16,788 | |||||||||||
| Other income (expense) | (97) | 659 | 225 | 3,943 | |||||||||||
| Income before income taxes | 10,722 | 8,401 | 33,754 | 20,731 | |||||||||||
| Provision for income taxes | 2,951 | 2,454 | 7,680 | 5,584 | |||||||||||
| Net income | $ | 7,771 | $ | 5,947 | $ | 26,074 | $ | 15,147 | |||||||
| Net income per share, basic | $ | 0.14 | $ | 0.11 | $ | 0.47 | $ | 0.28 | |||||||
| Net income per share, diluted | $ | 0.14 | $ | 0.11 | $ | 0.46 | $ | 0.28 | |||||||
| Weighted average shares outstanding, basic | 55,668,156 | 54,666,128 | 55,467,528 | 54,325,832 | |||||||||||
| Weighted average shares outstanding, diluted | 57,040,736 | 55,209,032 | 56,818,295 | 55,054,772 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30 2021 | December 31 2020 | ||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 50,522 | $ | 61,031 | |||
| Marketable securities | 355,446 | 306,709 | |||||
| Accounts receivable, net | 41,496 | 30,036 | |||||
| Inventory | 902 | 1,280 | |||||
| Prepaid expenses and other current assets | 13,442 | 10,089 | |||||
| Total current assets | 461,808 | 409,145 | |||||
| Property and equipment, net | 3,318 | 4,136 | |||||
| Operating lease right-of-use assets | 9,580 | 10,459 | |||||
| Intangible assets, net | 20,450 | 21,559 | |||||
| Deferred tax assets | 76,105 | 81,516 | |||||
| Non-current inventory and other | 8,506 | 6,641 | |||||
| Total assets | $ | 579,767 | $ | 533,456 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities | |||||||
| Accounts payable and accrued liabilities | $ | 31,820 | $ | 31,509 | |||
| Product revenue allowances | 40,177 | 34,427 | |||||
| Total current liabilities | 71,997 | 65,936 | |||||
| Operating lease non-current liabilities | 10,457 | 11,497 | |||||
| Other non-current liabilities | 3,992 | 2,757 | |||||
| Total liabilities | 86,446 | 80,190 | |||||
| Stockholders' equity | |||||||
| Common stock | 56 | 55 | |||||
| Additional paid-in capital | 664,408 | 650,300 | |||||
| Accumulated other comprehensive income | 111 | 239 | |||||
| Accumulated deficit | (171,254) | (197,328) | |||||
| Total stockholders' equity | 493,321 | 453,266 | |||||
| Total liabilities and stockholders' equity | $ | 579,767 | $ | 533,456 |
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals Inc.