Company to host conference call today at 4:30pm
ET
VIVUS, Inc. (NASDAQ: VVUS) (the "Company"), a specialty
pharmaceutical company committed to the development and
commercialization of innovative therapies focusing on treatments
for patients with serious unmet medical needs, today reported
financial results for the quarter ended June 30, 2018 and provided
a business update.
“The successful completion of the PANCREAZE
acquisition and the transaction with Athyrium Capital Management to
restructure a portion of our debt and access additional capital are
transformative events for VIVUS,” said John Amos, Chief Executive
Officer at VIVUS. “We are now strongly positioned to build a robust
portfolio of cash flow-positive assets that have clinical and
commercial value. Additionally, the positive pharmacokinetic data
reported for VI-0106 support continued evaluation of this novel
formulation of tacrolimus in the treatment of pulmonary arterial
hypertension, a serious disease with no curative therapy. We are
exploring options for advancing this promising program in a manner
consistent with our focus on reducing our debt. I am excited that
we are making tangible progress toward our goal of becoming a
profit-generating specialty pharmaceutical company.”
Recent Business Highlights
- VIVUS closes PANCREAZE® acquisition
and debt restructuring
In June 2018, VIVUS announced that it had met
the closing conditions, including Hart-Scott-Rodino review, related
to the Company’s acquisition of U.S. and Canadian rights to
PANCREAZE (pancrelipase) Delayed-Release Capsules for the treatment
of exocrine pancreatic insufficiency due to cystic fibrosis or
other conditions from Janssen Pharmaceuticals,
Inc. for $135 million in cash. Concurrently, VIVUS
completed a financing agreement with affiliates of Athyrium Capital
Management, L.P., to restructure a portion of the Company’s
debt.
- VIVUS announces positive preliminary Phase 1 VI-0106
results for PAH
In July 2018, VIVUS announced positive
preliminary results from a Phase 1 clinical study evaluating
VI-0106, a proprietary soft capsule formulation of tacrolimus for
the treatment of pulmonary arterial hypertension (PAH). The key
findings from the pharmacokinetic (PK) study involving healthy
volunteers showed that prototype formulations had PK profiles
consistent with earlier in-vitro evaluations, and an increased Area
Under the Curve compared to available immediate release
tacrolimus.
- VIVUS Appoints Kenneth Suh as President
VIVUS recently announced the appointment of Ken
Suh to the position of President. Previously, Mr. Suh was President
and CEO of Willow Biopharma Inc., a wholly-owned subsidiary of
VIVUS, Inc.
Financial Results
Revenue consisted of the following:
|
(In thousands)Three Months
Ended |
|
|
June 30, |
|
|
2018 |
|
2017 |
|
Qsymia net product revenue |
$ |
11,134 |
|
$ |
8,518 |
|
PANCREAZE net product revenue |
|
2,116 |
|
|
- |
|
Supply revenue |
|
1,042 |
|
|
2,119 |
|
Royalty revenue |
|
668 |
|
|
590 |
|
Total revenue |
$ |
14,960 |
|
$ |
11,227 |
|
Qsymia net product revenue increased to $11.1
million in the first quarter of 2018 as compared to $8.5 million in
the second quarter of 2017. The increase was primarily driven by
the increase in shipments to 94,000 units in the second quarter of
2018 as compared to 83,000 units in the same period in 2017.
Approximately 96,000 and 105,000 Qsymia prescriptions were
dispensed in the second quarters of 2018 and 2017,
respectively.
PANCREAZE net product revenue was $2.1 million
in the second quarter and consists of shipments made from the date
of our acquisition of PANCREAZE on June 8, 2018 through June 30,
2018. During this period, we shipped 7,000 units of PANCREAZE.
Total cost of goods sold excluding amortization
was $3.3 million and $3.4 million in the second quarters of 2018
and 2017, respectively. The decrease was primarily a result of
lower shipments of STENDRA/SPEDRA partially offset by higher
shipments of Qsymia and the addition of PANCREAZE product revenue
during the quarter.
Amortization of intangible assets was $1.3
million and $181,000 in the seconds quarters of 2018 and 2017,
respectively. In 2018, the increase was due to the amortization of
costs capitalized associated with the acquisition of PANCREAZE.
Research and development expense was $2.0
million and $1.0 million in the second quarters of 2018 and 2017,
respectively. Research and development expenses were impacted by
increased development efforts of tacrolimus for the treatment of
pulmonary arterial hypertension, specifically the Phase 1
pharmacokinetic study and continued formulation efforts
General and administrative expense was $8.2
million and $6.2 million for the second quarters of 2018 and 2017,
respectively. The increase in general and administrative was
primarily due to one-time expenses of approximately $2.0 million
related to advisory services and expenses related to the
acquisition of PANCREAZE and the restructuring of our debt, in
addition to the additional expense of adding three new members of
our senior leadership team.
Selling and marketing expense for the
commercialization of Qsymia totaled $3.5 million and $5.4 million
in the second quarters of 2018 and 2017, respectively. The decrease
was due to the continued cost control initiatives, including the
realignment of our sales force, and the refinement of our marketing
and promotional programs.
Total interest expense for the second quarter of
2018 was $8.7 million, as compared to $8.5 million in the second
quarter of 2017.
Net loss for the second quarter of 2018 was
$12.6 million, as compared to $13.4 million in the second quarter
of 2017. Cash, cash equivalents and available-for-sale securities
were $123.5 million at June 30, 2018.
Non-GAAP EBITDA for the second quarter of 2018
was ($1.0) million, as compared to ($4.0) in the second quarter of
2017. Excluding the one-time expenses discussed above, VIVUS
generated EBITDA of approximately $1.0 million during the second
quarter of 2018.
Conference Call Details
VIVUS will hold a conference call and an
audio webcast to provide a business update and to discuss the 2018
second quarter financial results today, August 7, 2018,
beginning at 4:30PM Eastern Time. Investors may listen to this
call by dialing toll-free 1-877-359-2916 in the U.S. and
1-224-357-2386 from outside the U.S. The audience passcode is
7977356. A webcast replay will be available for 30 days and may be
accessed at http://ir.vivus.com/events-and-presentations.
About Qsymia
Qsymia is approved in the U.S. and is indicated
as an adjunct to a reduced-calorie diet and increased physical
activity for chronic weight management in adults with an initial
body mass index (BMI) of 30 kg/m2 or greater (obese) or 27
kg/m2 or greater (overweight) in the presence of at least one
weight-related medical condition such as high blood pressure, type
2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity
and mortality has not been established. The safety and
effectiveness of Qsymia in combination with other products intended
for weight loss, including prescription and over-the-counter drugs,
and herbal preparations, have not been established.
For more information about Qsymia, please
visit www.Qsymia.com.
Important Safety Information for
Qsymia
Qsymia® (phentermine and topiramate
extended-release) capsules CIV is contraindicated in pregnancy; in
patients with glaucoma; in hyperthyroidism; in patients receiving
treatment or within 14 days following treatment with monoamine
oxidase inhibitors; or in patients with hypersensitivity to
sympathomimetic amines, topiramate, or any of the inactive
ingredients in Qsymia.
Qsymia can cause fetal harm. Females of
reproductive potential should have a negative pregnancy test before
treatment and monthly thereafter and use effective contraception
consistently during Qsymia therapy. If a patient becomes pregnant
while taking Qsymia, treatment should be discontinued immediately,
and the patient should be informed of the potential hazard to the
fetus.
The most commonly observed side effects in
controlled clinical studies, 5% or greater and at least 1.5 times
placebo, include paraesthesia, dizziness, dysgeusia, insomnia,
constipation, and dry mouth.
About PANCREAZE
PANCREAZE is a prescription medicine used to treat people who
cannot digest food normally because their pancreas does not make
enough enzymes due to cystic fibrosis or other conditions.
PANCREAZE may help your body use fats, proteins, and sugars from
food. PANCREAZE contains a mixture of digestive enzymes including
lipases, proteases, and amylases from pig pancreas. PANCREAZE is
safe and effective in children when taken as prescribed by your
doctor.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know
about PANCREAZE?
- PANCREAZE may increase your chance of having a serious, rare
bowel disorder called fibrosing colonopathy that may require
surgery.
- The risk of having this condition may be reduced by following
the dosing instructions that your healthcare provider gave
you.
Call your doctor right away if you have any unusual
or severe stomach area (abdominal) pain, bloating,
trouble passing stool (having bowel movements), nausea, vomiting,
or diarrhea.
Take PANCREAZE exactly as prescribed by your doctor. Do not take
more or less PANCREAZE than directed by your doctor.
What are the possible side effects of
PANCREAZE?
PANCREAZE may cause serious side effects,
including:
- A rare bowel disorder called fibrosing
colonopathy.
- Irritation of the inside of your mouth. This
can happen if PANCREAZE is not swallowed completely.
- Increase in blood uric acid levels. This
may cause worsening of swollen, painful joints (gout) caused by an
increase in your blood uric acid levels.
- Allergic reactions including trouble with
breathing, skin rashes, or swollen lips.
Call your doctor right away if you have any of these
symptoms.
The most common side effects include pain in your stomach
(abdominal pain) and gas.
Other possible side effects: PANCREAZE and other
pancreatic enzyme products are made from the pancreas of pigs, the
same pigs people eat as pork. These pigs may carry viruses.
Although it has never been reported, it may be possible for a
person to get a viral infection from taking pancreatic enzyme
products that come from pigs.
These are not all the side effects of PANCREAZE. Talk to your
doctor about any side effect that bothers you or does not go
away.
You may report side effects to FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
What should I tell my doctor before taking
PANCREAZE?
Tell your doctor if you:
- are allergic to pork (pig) products.
- have a history of blockage of your intestines, or scarring or
thickening of your bowel wall (fibrosing colonopathy).
- have gout, kidney disease, or high blood uric acid
(hyperuricemia).
- have trouble swallowing capsules.
- have any other medical condition.
- are pregnant or plan to become pregnant.
- are breast-feeding or plan to breast-feed.
Tell your doctor about all the medicines you
take, including prescription and nonprescription
medicines, vitamins, and herbal supplements.
The Product Information and Medication Guide for PANCREAZE is
available at www.pancreaze.com.
About STENDRA/SPEDRA
(Avanafil)
STENDRA® (avanafil) is approved in the U.S.
by the FDA for the treatment of erectile dysfunction.
Metuchen Pharmaceuticals LLC has exclusive marketing rights to
STENDRA in the U.S., Canada, South
America and India.
STENDRA is available through retail and mail
order pharmacies.
SPEDRA™, the trade name for avanafil in the EU,
is approved by the EMA for the treatment of erectile dysfunction in
the EU. VIVUS has granted an exclusive license to
the Menarini Group through its
subsidiary Berlin-Chemie AG to commercialize and promote
SPEDRA for the treatment of erectile dysfunction in over 40
European countries plus Australia and New
Zealand. Avanafil is licensed from Mitsubishi Tanabe
Pharma Corporation (MTPC). VIVUS owns worldwide
development and commercial rights to avanafil for the treatment of
sexual dysfunction, with the exception of certain Asian-Pacific Rim
countries. VIVUS is in discussions with other parties for the
commercialization rights to its remaining territories.
For more information about STENDRA, please
visit www.STENDRA.com.
Important Safety Information for
STENDRA
STENDRA® (avanafil) is prescribed to treat
erectile dysfunction (ED).Do not take STENDRA if you take nitrates,
often prescribed for chest pain, as this may cause a sudden, unsafe
drop in blood pressure.
Discuss your general health status with your
healthcare provider to ensure that you are healthy enough to engage
in sexual activity. If you experience chest pain, nausea, or any
other discomforts during sex, seek immediate medical help.
STENDRA may affect the way other medicines work.
Tell your healthcare provider if you take any of the following;
medicines called HIV protease inhibitors, such as ritonavir
(Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or
Invirase®) or atazanavir (Reyataz®); some types of oral antifungal
medicines, such as ketoconazole (Nizoral®), and itraconazole
(Sporanox®); or some types of antibiotics, such as clarithromycin
(Biaxin®), telithromycin (Ketek®), or erythromycin.
In the rare event of an erection lasting more
than 4 hours, seek immediate medical help to avoid long-term
injury.
In rare instances, men taking PDE5 inhibitors
(oral erectile dysfunction medicines, including STENDRA) reported a
sudden decrease or loss of vision. It is not possible to determine
whether these events are related directly to these medicines or to
other factors. If you experience sudden decrease or loss of vision,
stop taking PDE5 inhibitors, including STENDRA, and call a doctor
right away.
Sudden decrease or loss of hearing has been
rarely reported in people taking PDE5 inhibitors, including
STENDRA. It is not possible to determine whether these events are
related directly to the PDE5 inhibitors or to other factors. If you
experience sudden decrease or loss of hearing, stop taking STENDRA
and contact a doctor right away. If you have prostate problems or
high blood pressure for which you take medicines called alpha
blockers or other anti-hypertensives, your doctor may start you on
a lower dose of STENDRA.
Drinking too much alcohol when taking STENDRA
may lead to headache, dizziness, and lower blood pressure.
STENDRA in combination with other treatments for
ED is not recommended.
STENDRA does not protect against sexually
transmitted diseases, including HIV.
The most common side effects of STENDRA are
headache, flushing, runny nose and congestion.Please see full
patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg)
tablets.
About VIVUS
VIVUS is a specialty pharmaceutical company
committed to the development and commercialization of innovative
therapies that focus on advancing treatments for patients with
serious unmet medical needs. For more information about the
Company, please visit www.vivus.com.
Forward-Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995 and are subject to risks,
uncertainties and other factors, including risks and uncertainties
related to potential change in our business strategy to enhance
long-term stockholder value; risks and uncertainties related to our
ability to address or potentially reduce our outstanding balance of
the convertible notes due in 2020; risks and uncertainties related
to our expected future revenues, operations and expenditures; risks
and uncertainties related to our ability to identify and acquire
development and cash flow generating assets; risks and
uncertainties related to the timing, strategy, tactics and success
of the marketing and sales of PANCREAZE; risks and uncertainties
related to our commercialization of PANCREAZE as a new product and
our recently changed management team initiating the
commercialization of PANCREAZE; risks and uncertainties related to
our, or our partner's, ability to successfully commercialize
Qsymia; risks and uncertainties related to our ability to
successfully develop or acquire a proprietary formulation of
tacrolimus as a precursor to the clinical development process;
risks and uncertainties related to our ability to identify, acquire
and develop new product pipeline candidates; risks and
uncertainties related to our ability to develop a proprietary
formulation and to demonstrate through clinical testing the
quality, safety, and efficacy of our current or future
investigational drug candidates; risks and uncertainties related to
the timing, strategy, tactics and success of the commercialization
of STENDRA (avanafil) by our sublicensees; risks and uncertainties
related to our ability to successfully complete on acceptable
terms, and on a timely basis, avanafil partnering discussions for
territories under our license with MTPC in which we do not have a
commercial collaboration; risks and uncertainties related to the
failure to obtain FDA or foreign authority clearances or
approvals and noncompliance with FDA or foreign authority
regulations; and risks and uncertainties related to the impact, if
any, of changes to our Board of Directors and senior management
team. These risks and uncertainties could cause actual results to
differ materially from those referred to in these forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. Investors should read the risk
factors set forth in VIVUS’ Form 10-K for the year ended December
31, 2017 as filed on March 14, 2018, and as amended by the Form
10-K/A filed on April 26, 2018, and periodic reports filed with the
Securities and Exchange Commission. VIVUS does not undertake
an obligation to update or revise any forward-looking
statements.
VIVUS, Inc. |
Investor Relations: Lazar Partners |
Mark
Oki |
David
Carey |
Chief
Financial Officer
|
dcarey@lazarpartners.com |
oki@vivus.com |
212-867-1768 |
650-934-5200 |
|
VIVUS, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands, except par
value)
|
|
June 30, |
|
December 31, |
|
2018 |
|
2017 |
ASSETS |
|
Unaudited |
|
|
|
Current assets: |
|
|
|
|
|
Cash and
cash equivalents |
$ |
57,181 |
|
|
$ |
66,392 |
|
Available-for-sale securities |
|
66,361 |
|
|
|
159,943 |
|
Accounts
receivable, net |
|
11,071 |
|
|
|
12,187 |
|
Inventories |
|
22,259 |
|
|
|
17,712 |
|
Prepaid
expenses and other current assets |
|
6,399 |
|
|
|
7,178 |
|
Total
current assets |
|
163,271 |
|
|
|
263,412 |
|
Property and equipment,
net |
|
445 |
|
|
|
542 |
|
Intangible and other
non-current assets |
|
141,545 |
|
|
|
1,014 |
|
Total
assets |
$ |
305,261 |
|
|
$ |
264,968 |
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
$ |
4,345 |
|
|
$ |
10,072 |
|
Accrued
and other liabilities |
|
26,879 |
|
|
|
21,475 |
|
Deferred
revenue |
|
1,897 |
|
|
|
2,075 |
|
Current
portion of long-term debt |
|
— |
|
|
|
5,147 |
|
Total
current liabilities |
|
33,121 |
|
|
|
38,769 |
|
Long-term
debt, net of current portion |
|
295,498 |
|
|
|
230,536 |
|
Deferred
revenue, net of current portion |
|
4,243 |
|
|
|
4,674 |
|
Non-current accrued and other liabilities |
|
283 |
|
|
|
327 |
|
Total
liabilities |
|
333,145 |
|
|
|
274,306 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’
deficit: |
|
|
|
|
|
Preferred
stock; $1.00 par value; 5,000 shares authorized; no shares issued
and outstanding at June 30, 2018 and December 31,
2017 |
|
— |
|
|
|
— |
|
Common
stock; $.001 par value; 200,000 shares authorized; 106,187 and
105,977 shares issued and outstanding at June 30, 2018 and December
31, 2017, respectively |
|
106 |
|
|
|
105 |
|
Additional paid-in capital |
|
839,310 |
|
|
|
834,730 |
|
Accumulated other comprehensive loss |
|
(508 |
) |
|
|
(608 |
) |
Accumulated deficit |
|
(866,792 |
) |
|
|
(843,565 |
) |
Total
stockholders’ deficit |
|
(27,884 |
) |
|
|
(9,338 |
) |
Total
liabilities and stockholders’ deficit |
$ |
305,261 |
|
|
$ |
264,968 |
|
VIVUS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except per share
data)(Unaudited)
|
Three Months Ended |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2018 |
|
|
2017 |
2018 |
|
|
2017 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
product revenue |
$ |
13,250 |
|
|
$ |
8,518 |
|
|
$ |
22,882 |
|
|
$ |
26,138 |
|
License
and milestone revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,000 |
|
Supply
revenue |
|
1,042 |
|
|
|
2,119 |
|
|
|
2,725 |
|
|
|
5,931 |
|
Royalty
revenue |
|
668 |
|
|
|
590 |
|
|
|
1,253 |
|
|
|
1,170 |
|
Total
revenue |
|
14,960 |
|
|
|
11,227 |
|
|
|
26,860 |
|
|
|
38,239 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
goods sold (excluding amortization) |
|
3,286 |
|
|
|
3,389 |
|
|
|
5,916 |
|
|
|
9,375 |
|
Amortization of intangible assets |
|
1,273 |
|
|
|
181 |
|
|
|
1,364 |
|
|
|
362 |
|
Selling,
general and administrative |
|
11,711 |
|
|
|
11,630 |
|
|
|
21,779 |
|
|
|
23,061 |
|
Research
and development |
|
2,042 |
|
|
|
1,014 |
|
|
|
3,445 |
|
|
|
3,194 |
|
Total
operating expenses |
|
18,312 |
|
|
|
16,214 |
|
|
|
32,504 |
|
|
|
35,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from
operations |
|
(3,352) |
|
|
|
(4,987 |
) |
|
|
(5,644 |
) |
|
|
2,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense and other expense, net |
|
9,218 |
|
|
|
8,398 |
|
|
|
17,567 |
|
|
|
16,700 |
|
Loss before income
taxes |
|
(12,570 |
) |
|
|
(13,385 |
) |
|
|
(23,211 |
) |
|
|
(14,453 |
) |
Provision for (benefit
from) income taxes |
|
4 |
|
|
|
1 |
|
|
|
16 |
|
|
|
(11 |
) |
Net
loss |
$ |
(12,574 |
) |
|
$ |
(13,386 |
) |
|
$ |
(23,227 |
) |
|
$ |
(14,442 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share: |
$ |
(0.12 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.14 |
) |
Shares used in per
share computation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
106,116 |
|
|
|
105,712 |
|
|
|
106,065 |
|
|
|
105,596 |
|
VIVUS, INC.
GAAP to NON-GAAP
RECONCILIATIONNET LOSS to
EBITDA(In
thousands)(Unaudited)
A reconciliation between net loss on a GAAP
basis and non-GAAP EBITDA is as follows:
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Net loss |
$ |
(12,574 |
) |
|
$ |
(13,386 |
) |
|
$ |
(23,227 |
) |
|
$ |
(14,442 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Interest
expense and other expense, net |
|
9,218 |
|
|
|
8,398 |
|
|
|
17,567 |
|
|
|
16,700 |
|
Depreciation of fixed assets |
|
65 |
|
|
|
68 |
|
|
|
131 |
|
|
|
139 |
|
Amortization of intangible assets |
|
1,273 |
|
|
|
181 |
|
|
|
1,364 |
|
|
|
362 |
|
Share-based compensation expense |
|
1,049 |
|
|
|
741 |
|
|
|
1,974 |
|
|
|
1,468 |
|
Provision
for (benefit from) income taxes |
|
4 |
|
|
|
1 |
|
|
|
16 |
|
|
|
(11 |
) |
Non-GAAP
EBITDA |
$ |
(965 |
) |
|
$ |
(3,997 |
) |
|
$ |
(2,175 |
) |
|
$ |
4,216 |
|
Use of Non-GAAP Financial Measures
We supplement our condensed consolidated
financial statements presented on a GAAP basis by providing an
additional measure which is considered non-GAAP under applicable
SEC rules. We believe that the disclosure of this non-GAAP measure
provides investors with additional information that reflects the
basis upon which our management assesses and operates our business.
This non-GAAP financial measure is not in accordance with GAAP and
should not be viewed in isolation or as a substitute for GAAP net
loss and is not a substitute for, or superior to, measures of
financial performance performed in conformity with GAAP.
We define non-GAAP EBITDA as net loss before
interest and other expense, depreciation of fixed assets,
amortization of intangible assets, share-based compensation expense
and provision for or benefit from income taxes. Management believes
that non-GAAP EBITDA is a meaningful indicator of our performance
and provides useful information to investors regarding our results
of operations and financial condition.
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