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 September 30, 2018 and
provided a business update.
“Our third quarter 2018 results are the first
full quarter under our newly integrated management team and we are
pleased with our improved financial performance,” said John Amos,
Chief Executive Officer at VIVUS. “Earlier this year, we announced
a set of initiatives geared toward executing on our business
strategy to improve our financial structure and commercial
opportunities. During the quarter, we continued to implement these
initiatives with a focus on growing product revenues and recurring
EBITDA. The repayment of $8.574 million of convertible debt, saving
us approximately $2 million of principal and interest through May
2020, and regaining Nasdaq listing compliance are recent
achievements. Going forward, our primary areas of focus are
relaunching PANCREAZE under the VIVUS brand, improving sales and
marketing for Qsymia, identifying capital and development partners
for VI-0106, pursuing cash flow generating acquisitions, and
continuing to address our financial structure.”
Recent Business Highlights
- Addition of two new members to the Board of
DirectorsIn October 2018, VIVUS announced the appointments
of Karen Ferrell and Edward A. Kangas to VIVUS’ board of directors.
With these appointments, VIVUS’ board of directors expands to nine
members in total.
- Retirement of $8.574 million of its Convertible Notes
due 2020In October 2018, VIVUS repurchased $8.574 million
of its convertible notes due May 2020 at a discount to par plus
accrued and unpaid interest. The repurchase of the notes is
expected to save the Company approximately $2 million in principal
and interest between the transaction date and the due date.
- 1-for-10 reverse stock split and regaining compliance
with Nasdaq Listing RequirementsIn September 2018, VIVUS’
stockholders approved the Company’s 1-for-10 reverse stock split
and shares began trading on a split adjusted basis on September 11,
2018. In addition, Nasdaq notified the Company that it had achieved
compliance with the minimum bid price rule and is in compliance
with other applicable requirements required for continued listing
on The Nasdaq Capital Market.
Financial Results
Revenue consisted of the following:
|
|
(In
thousands)Three Months Ended |
|
|
|
September 30, |
|
|
|
2018 |
|
2017 |
|
Qsymia net product revenue |
|
$ |
9,737 |
|
$ |
9,911 |
|
PANCREAZE net product revenue |
|
|
6,747 |
|
|
-- |
|
License and milestone revenue |
|
|
-- |
|
|
2,500 |
|
Supply revenue |
|
|
478 |
|
|
2,133 |
|
Royalty revenue |
|
|
1,126 |
|
|
649 |
|
Total revenue |
|
$ |
18,088 |
|
$ |
15,193 |
|
Total revenue for the third quarter of 2018 was
$18.1 million, an increase of 19% compared to $15.1 million during
the same period in 2017.
Qsymia net product revenue was $9.7 million and
$9.9 million in the third quarters of 2018 and 2017, respectively.
The slight decrease was primarily due to a decrease in shipments to
86,000 units in the third quarter of 2018 as compared to 92,000
units in 2017. Approximately 89,000 and 97,000 Qsymia prescriptions
were dispensed in the third quarters of 2018 and 2017,
respectively. Sales of Qsymia tend to be significantly impacted by
seasonality and future sales of Qsymia could differ materially from
third quarter results.
PANCREAZE net product revenue was $6.7 million
in the third quarter of 2018. VIVUS acquired PANCREAZE in June 2018
and the third quarter of 2018 represents the Company’s first full
quarter of PANCREAZE revenue. During this period, the Company
shipped 34,000 units of PANCREAZE. Future PANCREAZE net product
revenues will be negatively impacted by higher fees as VIVUS takes
over supply chain management and potential promotional strategies,
including the issuance of discount coupons.
Total cost of goods sold excluding amortization
was $3.5 million and $3.4 million in the third quarters of 2018 and
2017, respectively.
Amortization of intangible assets was $3.6
million and $91,000 in the third quarters of 2018 and 2017,
respectively. The increase was due to the amortization of costs
capitalized with the acquisition of PANCREAZE.
Research and development expense was $2.1
million and $0.9 million in the third quarters of 2018 and 2017,
respectively. Research and development expenses were impacted by
increased development efforts of VI-0106 for the treatment of
pulmonary arterial hypertension, specifically the Phase 1
pharmacokinetic study and continued formulation efforts. VIVUS also
assumed post marketing requirements from Janssen as part of the
acquisition of PANCREAZE. VIVUS expects research and development
expenses to increase in connection with initiation of enrollment in
the Qsymia adolescent safety and efficacy study (OB-0403) beginning
in the first quarter of 2019.
General and administrative expense was $5.4
million and $5.6 million for the third quarters of 2018 and 2017,
respectively. The decrease was primarily due to control of expenses
and financial discipline. VIVUS expects general and administrative
expenses to slightly increase as the Company continues the
integration of PANCREAZE activities.
Selling and marketing expense for the
commercialization of Qsymia totaled $3.1 million and $2.8 million
in the third quarters of 2018 and 2017, respectively. The small
increase was due to the refinement of the company’s marketing and
promotional programs. VIVUS expects to increase commercialization
efforts for PANCREAZE, including potential additions to its field
force and potential administrative, partnering and promotional
activities.
Total interest and other expense was $9.6
million and $8.4 million for the third quarters of 2018 and 2017,
respectively. On an annual basis, after our October repurchase of
$8.574 million of convertible notes, we will make payments of
approximately $19.6 million on our convertible and senior secured
notes.
Net loss for the third quarter of 2018 was $9.2
million, as compared to $6.0 million in the third quarter of 2017.
Cash, cash equivalents and available-for-sale securities were
$115.1 million at September 30, 2018.
Non-GAAP EBITDA for the third quarter of 2018
was $4.8 million, as compared to $0.8 million, excluding one-time
license fees, in the third quarter of 2017.
Conference Call Details
VIVUS will hold a conference call and an
audio webcast to provide a business update and to discuss the 2018
third quarter financial results today, November 1, 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
3792846. 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,
including our ability to identify capital and development partners;
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)
|
|
|
|
|
|
|
September
30, |
|
December 31, |
|
2018 |
|
|
2017 |
|
ASSETS |
|
Unaudited |
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
58,022 |
|
|
$ |
66,392 |
|
Available-for-sale securities |
|
57,096 |
|
|
|
159,943 |
|
Accounts receivable, net |
|
23,625 |
|
|
|
12,187 |
|
Inventories |
|
21,603 |
|
|
|
17,712 |
|
Prepaid expenses and other current assets |
|
7,744 |
|
|
|
7,178 |
|
Total current assets |
|
168,090 |
|
|
|
263,412 |
|
Property and equipment, net |
|
381 |
|
|
|
542 |
|
Intangible and other non-current assets |
|
137,918 |
|
|
|
1,014 |
|
Total assets |
$ |
306,389 |
|
|
$ |
264,968 |
|
LIABILITIES AND STOCKHOLDERS’
DEFICIT |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
4,483 |
|
|
$ |
10,072 |
|
Accrued and other liabilities |
|
31,924 |
|
|
|
21,475 |
|
Deferred revenue |
|
2,159 |
|
|
|
2,075 |
|
Current portion of long-term debt |
|
-- |
|
|
|
5,147 |
|
Total current liabilities |
|
38,566 |
|
|
|
38,769 |
|
Long-term debt, net of current portion |
|
300,182 |
|
|
|
230,536 |
|
Deferred revenue, net of current portion |
|
3,686 |
|
|
|
4,674 |
|
Non-current accrued and other liabilities |
|
258 |
|
|
|
327 |
|
Total liabilities |
|
342,692 |
|
|
|
274,306 |
|
Commitments and contingencies |
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
Preferred stock; $.001 par value; 5,000 shares
authorized; no shares issued and outstanding at September
30, 2018 and December 31, 2017 |
|
— |
|
|
|
— |
|
Common stock; $.001 par value; 200,000 shares
authorized; 10,628 and 10,603 shares issued and outstanding at
September 30, 2018 and December 31, 2017, respectively |
|
11 |
|
|
|
11 |
|
Additional paid-in capital |
|
840,100 |
|
|
|
834,824 |
|
Accumulated other comprehensive loss |
|
(399 |
) |
|
|
(608 |
) |
Accumulated deficit |
|
(876,015 |
) |
|
|
(843,565 |
) |
Total stockholders’ deficit |
|
(36,303 |
) |
|
|
(9,338 |
) |
Total liabilities and stockholders’ deficit |
$ |
306,389 |
|
|
$ |
264,968 |
|
VIVUS, INC.CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS(In thousands, except per
share data)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
September 30, |
|
September 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
Net product revenue |
$ |
16,484 |
|
$ |
9,911 |
|
$ |
39,366 |
|
$ |
36,049 |
License and milestone revenue |
|
-- |
|
|
2,500 |
|
|
-- |
|
|
7,500 |
Supply revenue |
|
478 |
|
|
2,133 |
|
|
3,203 |
|
|
8,064 |
Royalty revenue |
|
1,126 |
|
|
649 |
|
|
2,379 |
|
|
1,819 |
Total revenue |
|
18,088 |
|
|
15,193 |
|
|
44,948 |
|
|
53,432 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization) |
|
3,484 |
|
|
3,423 |
|
|
9,400 |
|
|
12,798 |
Amortization of intangible assets |
|
3,638 |
|
|
91 |
|
|
5,002 |
|
|
453 |
Selling, general and administrative |
|
8,456 |
|
|
8,388 |
|
|
30,235 |
|
|
31,449 |
Research and development |
|
2,102 |
|
|
865 |
|
|
5,547 |
|
|
4,059 |
Total operating expenses |
|
17,680 |
|
|
12,767 |
|
|
50,184 |
|
|
48,759 |
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
408 |
|
|
2,426 |
|
|
(5,236) |
|
|
4,673 |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense and other expense, net |
|
9,595 |
|
|
8,412 |
|
|
27,162 |
|
|
25,112 |
Loss before income taxes |
|
(9,187) |
|
|
(5,986) |
|
|
(32,398) |
|
|
(20,439) |
Provision for (benefit from) income taxes |
|
36 |
|
|
8 |
|
|
52 |
|
|
(3) |
Net loss |
$ |
(9,223) |
|
$ |
(5,994) |
|
$ |
(32,450) |
|
$ |
(20,436) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share: |
$ |
(0.87) |
|
$ |
(0.57) |
|
$ |
(3.06) |
|
$ |
(1.93) |
Shares used in per share computation: |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
10,628 |
|
|
10,583 |
|
|
10,617 |
|
|
10,567 |
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 |
|
Nine Months
Ended |
|
September 30, |
|
September 30, |
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Net loss |
$ |
(9,223 |
) |
|
$ |
(5,994 |
) |
|
$ |
(32,450 |
) |
|
$ |
(20,436 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Interest expense and other expense, net |
|
9,595 |
|
|
|
8,412 |
|
|
|
27,162 |
|
|
|
25,112 |
|
Depreciation of fixed assets |
|
64 |
|
|
|
64 |
|
|
|
195 |
|
|
|
203 |
|
Amortization of intangible assets |
|
3,638 |
|
|
|
91 |
|
|
|
5,002 |
|
|
|
453 |
|
Share-based compensation expense |
|
676 |
|
|
|
753 |
|
|
|
2,650 |
|
|
|
2,221 |
|
Provision for (benefit from) income taxes |
|
36 |
|
|
|
8 |
|
|
|
52 |
|
|
|
(3 |
) |
Non-GAAP EBITDA |
$ |
4,786 |
|
|
$ |
3,334 |
|
|
$ |
2,611 |
|
|
$ |
7,550 |
|
Non-recurring revenue |
|
-- |
|
|
|
(2,500 |
) |
|
|
-- |
|
|
|
(7,500 |
) |
Non-GAAP Recurring EBITDA |
$ |
4,786 |
|
|
$ |
834 |
|
|
$ |
2,611 |
|
|
$ |
50 |
|
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. We define non-GAAP
Recurring EBITDA as non-GAAP EBITDA adjusted for certain
non-recurring revenues and expenses, such as non-recurring
milestone revenues and non-recurring restructuring costs.
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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