"We are very proud of the achievements of our team, especially the record commercial performance, even in the face of the challenges presented by the pandemic. We are also very excited with the progress of the HETLIOZ® SMS applications as we get closer to providing a therapeutic solution to patients with SMS," said
Key Financial and Corporate Highlights
- Total revenues from HETLIOZ® and Fanapt® were
$62.2 million in the second quarter of 2020, a 5% increase compared to$59.1 million in the second quarter of 2019. - HETLIOZ® net product sales were
$41.6 million in the second quarter of 2020, a 10% increase compared to$37.8 million in the second quarter of 2019. - Fanapt® net product sales were
$20.6 million in the second quarter of 2020, a 3% decrease compared to$21.2 million in the second quarter of 2019. - Cash, cash equivalents and marketable securities (Cash) were
$339.8 million as ofJune 30, 2020 , representing an increase to Cash of$47.2 million compared toJune 30, 2019 . - Net income was
$8.7 million in the second quarter of 2020 compared to net income of$11.5 million in the second quarter of 2019.
Key Product and Pipeline Highlights
Products
Vanda is encouraged by its record commercial performance during the second quarter of 2020. Vanda continues to implement marketing and sales strategies aimed at supporting continued growth and minimizing the impact of disruptions caused by the COVID-19 pandemic, including the launch of a Fanapt® for schizophrenia direct-to-consumer campaign at the end of the second quarter of 2020.
Pipeline
The COVID-19 pandemic has impacted clinical research globally, including Vanda's previously reported clinical trials. The tradipitant gastroparesis and motion sickness programs have resumed, while recruitment for the tradipitant atopic dermatitis program, as well as the HETLIOZ® delayed sleep phase disorder study and Fanapt® bipolar disorder and long acting injectable studies, is currently on hold.
Tradipitant
- An Individual Patient Expanded Access protocol (VP-VLY-686-3303) for tradipitant in gastroparesis was approved by the
U.S. Food and Drug Administration (FDA) and the patient was enrolled inJuly 2020 . Under this protocol, this patient will receive tradipitant treatment for a period of up to six months, which may be extended upon review by the FDA. - The gastroparesis Phase III clinical study (VP-VLY-686-3301) resumed recruitment. Enrollment in this 200-person study is expected to be completed in the first half of 2021 with a New Drug Application (NDA) filing projected for later that year.
- The protocol for the pivotal Phase III motion sickness study was discussed with the FDA at the end of Phase II meeting, and the FDA agrees with the adequacy of the program design to support an application. Preparations for this study have begun with the boat trip portion of the study expected to commence as soon as local restrictions are lifted.
- Patient enrollment in the Phase III clinical study (ODYSSEY VLY-686-3501) of tradipitant in COVID-19 Acute Respiratory Distress Syndrome (ARDS) is ongoing and an interim analysis will be conducted to determine next steps.
HETLIOZ® (tasimelteon)
- The Smith-Magenis Syndrome (SMS) marketing authorization applications were accepted by the FDA for priority review with a Prescription Drug User Fee Act (PDUFA-VI) target action date of
December 1, 2020 .1 - The FDA appeals process related to the sNDA for HETLIOZ® for the treatment of jet lag disorder is ongoing.
- The article "Efficacy and Safety of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial" was accepted for publication in the
July 2020 issue of Gastroenterology.2 - The article "Efficacy of Tasimelteon (HETLIOZ®) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial" was published in the
July 2020 issue of Frontiers in Neurology.3
GAAP Financial Results
Net income was
2020 Financial Guidance
Vanda will continue to assess the impact of the evolving pandemic on its business and operations and will provide future updates to its financial guidance as necessary. The financial guidance previously communicated by Vanda is shown below. In addition, Vanda provides an update to Year-end 2020 Cash.
Full Year 2020 Financial Objectives |
Full Year 2020 Guidance
|
Total revenues
|
|
HETLIOZ® net product sales
|
|
Fanapt® net product sales
|
|
Year-end 2020 Cash |
Greater than |
Conference Call
Vanda has scheduled a conference call for today,
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.
References:
1 Refer to Company press release titled "FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ® (tasimelteon) in the Treatment of Smith-Magenis Syndrome" issued on
2 Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao, C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H., & Polymeropoulos, M. H. (2020). Efficacy and safety of tradipitant in patients with diabetic and idiopathic gastroparesis in a randomized, placebo-controlled trial. Gastroenterology. Advance online publication. https://doi.org/10.1053/j.gastro.2020.07.029
3 Polymeropoulos, C. M., Mohrman, M. A., Keefe, M. S., Brzezynski, J. L., Wang, J., Prokosch, L. S., Polymeropoulos, V. M., Xiao, C., Birznieks, G., & Polymeropoulos, M. H. (2020). Efficacy of tasimelteon (Hetlioz®) in the treatment of jet lag disorder evaluated in an 8-h phase advance model; a multicenter, randomized, double-blind, placebo-controlled trial. Frontiers in Neurology, 11, 611. https://doi.org/10.3389/fneur.2020.00611
About
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
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not limited to, the guidance provided under "2020 Financial Guidance" above and statements regarding Vanda's ability to make HETLIOZ® available to patients with SMS, Vanda's marketing and sales strategies, the Individual Patient Expanded Access protocol for tradipitant, recruitment for the gastroparesis, motion sickness and ODYSSEY studies and clinical development and regulatory timelines for tradipitant and HETLIOZ® 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
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except for share and per share amounts) (unaudited) |
|||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
|
|
|
|
||||||||||||
Revenues: |
|||||||||||||||
HETLIOZ® net product sales |
$ |
41,561 |
$ |
37,835 |
$ |
76,897 |
$ |
66,792 |
|||||||
Fanapt® net product sales |
20,646 |
21,225 |
43,310 |
39,981 |
|||||||||||
Total revenues |
62,207 |
59,060 |
120,207 |
106,773 |
|||||||||||
Operating expenses: |
|||||||||||||||
Cost of goods sold excluding amortization |
5,847 |
6,368 |
11,054 |
11,481 |
|||||||||||
Research and development |
12,903 |
10,950 |
28,430 |
24,228 |
|||||||||||
Selling, general and administrative |
33,917 |
31,468 |
70,938 |
62,497 |
|||||||||||
Intangible asset amortization |
369 |
379 |
739 |
759 |
|||||||||||
Total operating expenses |
53,036 |
49,165 |
111,161 |
98,965 |
|||||||||||
Income from operations |
9,171 |
9,895 |
9,046 |
7,808 |
|||||||||||
Other income |
1,918 |
1,649 |
3,284 |
3,134 |
|||||||||||
Income before income taxes |
11,089 |
11,544 |
12,330 |
10,942 |
|||||||||||
Provision for income taxes |
2,375 |
18 |
3,130 |
28 |
|||||||||||
Net income |
$ |
8,714 |
$ |
11,526 |
$ |
9,200 |
$ |
10,914 |
|||||||
|
$ |
0.16 |
$ |
0.22 |
$ |
0.17 |
$ |
0.21 |
|||||||
Net income per share, diluted |
$ |
0.16 |
$ |
0.21 |
$ |
0.17 |
$ |
0.20 |
|||||||
|
54,501,308 |
53,101,499 |
54,153,812 |
52,928,101 |
|||||||||||
Weighted average shares outstanding, diluted |
55,081,397 |
54,579,982 |
54,975,771 |
54,932,932 |
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) |
|||||||
|
|
||||||
ASSETS |
|||||||
Current assets: |
|||||||
Cash and cash equivalents |
$ |
95,305 |
$ |
45,072 |
|||
Marketable securities |
244,544 |
267,057 |
|||||
Accounts receivable, net |
24,587 |
26,367 |
|||||
Inventory |
1,384 |
1,140 |
|||||
Prepaid expenses and other current assets |
15,041 |
14,500 |
|||||
Total current assets |
380,861 |
354,136 |
|||||
Property and equipment, net |
3,744 |
3,864 |
|||||
Operating lease right-of-use assets |
10,601 |
11,180 |
|||||
Intangible assets, net |
22,298 |
23,037 |
|||||
Deferred tax assets |
85,558 |
87,680 |
|||||
Non-current inventory and other |
3,569 |
3,851 |
|||||
Total assets |
$ |
506,631 |
$ |
483,748 |
|||
|
|||||||
Current liabilities: |
|||||||
Accounts payable and accrued liabilities |
$ |
28,398 |
$ |
27,590 |
|||
Product revenue allowances |
33,194 |
31,915 |
|||||
Total current liabilities |
61,592 |
59,505 |
|||||
Operating lease non-current liabilities |
11,720 |
12,455 |
|||||
Other non-current liabilities |
1,735 |
843 |
|||||
Total liabilities |
75,047 |
72,803 |
|||||
Stockholders' equity: |
|||||||
Common stock |
55 |
54 |
|||||
Additional paid-in capital |
642,398 |
631,307 |
|||||
Accumulated other comprehensive income |
596 |
249 |
|||||
Accumulated deficit |
(211,465) |
(220,665) |
|||||
Total stockholders' equity |
431,584 |
410,945 |
|||||
Total liabilities and stockholders' equity |
$ |
506,631 |
$ |
483,748 |
Corporate Contact:
AJ Jones II
Chief Corporate Affairs and Communications Officer
202-734-3400
pr@vandapharma.com
Head of Corporate Affairs
202-734-3400
pr@vandapharma.com
View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-second-quarter-2020-financial-results-301106946.html
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