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 March 31, 2019 and provided
a business update.
“The first quarter of 2019 represents the
completion of the third quarter of our ten-quarter turnaround,”
said John Amos, Chief Executive Officer at VIVUS. “After
successfully stabilizing the business in the third and fourth
quarters of 2018, we made important progress in the first quarter
of 2019 toward establishing a solid base for future growth.
This included the re-launch of Qsymia and PANCREAZE and,
while early in the re-launch process, leading indicators suggest
that we will see improved financial performance for both products
in the third quarter of 2019. We are pleased with our progress to
date on our ten-quarter turnaround and look forward to building on
this momentum over the coming quarters.”
Mr. Amos continued, “Over the past three
quarters, VIVUS has made multiple strategic investments into the
business, including one-time expenses of approximately $6
million. The investments include product enhancements for
PANCREAZE, implementation of a PANCREAZE sampling program,
preparation of the Phase 4 adolescent Qsymia safety and efficacy
study, development of VIVUS Health Platform, which includes the
PANCREAZE Advantage and Qsymia Advantage programs, and other
one-time investments that are expected to drive long-term
performance and stockholder value.”
Recent Business Highlights
- Launching PANCREAZE Under the VIVUS BrandIn
February 2019, VIVUS completed the transition of the supply chain
for PANCREAZE Delayed-Release Capsules in the United States from
Janssen Pharmaceuticals, Inc. to VIVUS. Concurrent with this
transition, the Company successfully re-launched PANCREAZE under
the VIVUS brand.
- Announcing Marketing Approval of Avanafil in the
Russian FederationIn March 2019, the Ministry of Health of
the Russian Federation approved 50 mg, 100 mg and 200 mg tablets of
avanafil for the treatment of erectile dysfunction (ED). The
product will be marketed in the Russian Federation under the brand
name RAZATUS.
- Receiving Marketing Approval of Avanafil in the United
Arab EmiratesIn February 2019, the Ministry of Health
& Prevention of the United Arab Emirates approved 100 mg and
200 mg tablets of avanafil. The product will be marketed in the
United Arab Emirates under the brand name SPEDRA.
- Publishing of Data Supporting the Cardiovascular Safety
of QsymiaIn February 2019, results from a new
retrospective study evaluating the cardiovascular safety of
Qsymia® (phentermine and topiramate extended-release) capsules
CIV were published in The Journal of Clinical Endocrinology
& Metabolism and are currently
available online. The new findings indicate that the
combined risk of major adverse cardiovascular events (MACE) was not
elevated in patients currently taking Qsymia, or concurrently
taking both phentermine and topiramate, compared with former users
of these medications. The number of MACE events (3 events during
3,245 person-years of follow-up) was too few to draw a definitive
conclusion from the data.
First Quarter Financial
Results
Revenue consisted of the following:
|
|
|
(In thousands)Three Months
Ended |
|
|
|
|
March 31, |
|
|
|
|
2019 |
|
2018 |
|
|
Qsymia net product
revenue |
|
$ |
8,423 |
|
$ |
9,632 |
|
|
PANCREAZE net product revenue |
|
|
5,074 |
|
|
— |
|
|
Supply revenue |
|
|
1,604 |
|
|
1,683 |
|
|
Royalty revenue |
|
|
1,045 |
|
|
585 |
|
|
Total revenue |
|
$ |
16,146 |
|
$ |
11,900 |
|
|
|
|
|
|
|
|
|
|
Total revenue for the first quarter of 2019 was
$16.1 million, an increase of 36% compared to $11.9 million during
the same period in 2018.
Qsymia net product revenue was $8.4 million and
$9.6 million in the first quarters of 2019 and 2018, respectively.
Shipments were approximately 75,000 and 83,000 units in the
first quarters of 2019 and 2018, respectively. The decrease
in shipments was primarily due to lower script volumes and supply
chain management by wholesalers. Approximately 82,000 and 92,000
Qsymia prescriptions were dispensed in the first quarters of 2019
and 2018, respectively. The Company made a number of changes
to the Qsymia business in an effort to improve commercial
performance, primarily allowing patients to migrate from a
traditional retail pharmacy model to the Qsymia Advantage model
that is expected to improve access to Qsymia through, among other
things, direct-to-patient distribution and improved pricing.
The Company anticipates that this transfer, which started in
February of 2019 with the re-launch, will be one of the key drivers
of brand performance in the second half of 2019 and full year 2020.
During the first quarter, Qsymia generated a modest increase
in prescription numbers under the Direct-to-Patient model despite
the limited rollout of the program.
PANCREAZE net product revenue was $5.1 million
in the first quarter of 2019. While VIVUS acquired PANCREAZE in
June 2018, VIVUS started shipping VIVUS branded product in the
first quarter of 2019. During this period, the Company shipped
approximately 26,000 units of PANCREAZE. As expected, the first
quarter PANCREAZE revenue was negatively impacted by the marketing
under a new label, fully burdened expenses, and market
change. The Company views first quarter 2019 PANCREAZE
revenues as the true first quarter of brand performance.
VIVUS now has a dedicated 10-person sales force, sampling program,
full patient support program, plan for investigator sponsored
trials in oncology, digital marketing campaign strategy, and a
number of other enhancements. PANCREAZE new patient starts in the
first quarter of 2019, the most important key performance indicator
for a re-launched brand, were up by approximately 10% from four
weeks prior to the re-launch.
Total cost of goods sold excluding amortization
was $4.3 million and $2.6 million in the first quarters of 2019 and
2018, respectively. The growth was primarily due to the addition of
PANCREAZE revenue in 2018.
Amortization of intangible assets was $3.6
million and $91,000 in the first quarters of 2019 and 2018,
respectively. The increase was due to the amortization of costs
capitalized with the acquisition of PANCREAZE.
General and administrative expense was $5.3
million and $5.8 million for the first quarters of 2019 and 2018,
respectively. The decrease was primarily due to lower business
development efforts in 2019 compared to 2018. VIVUS expects general
and administrative expenses to fluctuate with business development
activities.
Selling and marketing expense totaled $4.5
million and $4.3 million in the first quarters of 2019 and 2018,
respectively. The increase was primarily due to
commercialization efforts for PANCREAZE, including additions to its
field force that supported the re-launch in the first quarter of
2019, and promotional activities.
Research and development expense was $2.5
million and $1.4 million in the first quarters of 2019 and 2018,
respectively. Research and development expenses were impacted by
the activities related to the Qsymia adolescent safety and efficacy
study (OB-0403), PANCREAZE post-marketing requirements assumed from
Janssen and ongoing PANCREAZE product improvement initiatives.
Total interest and other expense was $3.9
million and $8.3 million for the first quarters of 2019 and 2018,
respectively. The decrease is due to the pay down of debt in 2018,
partially offset by the additional debt issued in June 2018. On an
annual basis, VIVUS will make cash interest payments of
approximately $19.6 million on its convertible and senior secured
notes.
Net loss for the first quarter of 2019 was $7.9
million, as compared to $10.7 million in the first quarter of
2018. Cash, cash equivalents and available-for-sale
securities were $104.7 million at March 31, 2019.
Non-GAAP EBITDA for the first quarter of 2019
was $0.1 million, as compared to EBITDA of negative $1.2 million in
the first quarter of 2018.
Conference Call Details
VIVUS will hold a conference call and an
audio webcast to provide a business update and to discuss first
quarter 2019 financial results today, April 30, 2019,
beginning at 4:30 PM 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 4079554. 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 for PANCREAZE
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 our ability to execute on 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 cash flow generating assets and opportunities;
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 current or potential partner's, ability to successfully
commercialize Qsymia; risks and uncertainties related to our
ability to successfully develop or acquire a proprietary
formulation of tacrolimus; 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
launches and commercialization of STENDRA/SPEDRA (avanafil) by our
current or potential collaborators; 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 our ability to
work with FDA to significantly reduce or remove the requirements of
the clinical post-approval cardiovascular outcomes trial (“CVOT”);
risks and uncertainties related to our dialog with the European
Medicines Agency (“EMA”) relating to the U.S.-based CVOT for
Qsymia, and the resubmission of an application for the grant of a
marketing authorization to EMA, the timing and scope of such
resubmission, if any, the results of any required CVOT, the
assessment by EMA of the application for marketing authorization,
and their agreement with the data from any required CVOT and
ultimately the decision of the European Commission whether to grant
marketing authorization for Qsymia in the EU; 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 our ability to successfully integrate
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, 2018 as filed on February 26, 2019, 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)
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2019 |
|
2018 |
ASSETS |
|
Unaudited |
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash
equivalents |
$ |
23,021 |
|
|
$ |
30,411 |
|
Available-for-sale securities |
|
81,632 |
|
|
|
80,838 |
|
Accounts
receivable, net |
|
24,554 |
|
|
|
25,608 |
|
Inventories |
|
21,946 |
|
|
|
23,132 |
|
Prepaid
expenses and other current assets |
|
6,568 |
|
|
|
7,538 |
|
Total
current assets |
|
157,721 |
|
|
|
167,527 |
|
Property and equipment,
net |
|
325 |
|
|
|
341 |
|
Right-of-use
assets |
|
1,496 |
|
|
|
— |
|
Intangible and other
non-current assets |
|
130,641 |
|
|
|
134,279 |
|
Total
assets |
$ |
290,183 |
|
|
$ |
302,147 |
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
$ |
3,615 |
|
|
$ |
8,921 |
|
Accrued
and other liabilities |
|
33,391 |
|
|
|
33,044 |
|
Deferred
revenue |
|
1,255 |
|
|
|
1,235 |
|
Current
portion of lease liability |
|
705 |
|
|
|
— |
|
Total
current liabilities |
|
38,966 |
|
|
|
43,200 |
|
Long-term
debt, net of current portion |
|
293,396 |
|
|
|
294,446 |
|
Deferred
revenue, net of current portion |
|
3,975 |
|
|
|
4,290 |
|
Lease
liability, net of current portion |
|
1,091 |
|
|
|
— |
|
Non-current accrued and other liabilities |
|
— |
|
|
|
234 |
|
Total
liabilities |
|
337,428 |
|
|
|
342,170 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’
deficit: |
|
|
|
|
|
Preferred
stock; $.001 par value; 5,000 shares authorized; no shares issued
and outstanding at March 31, 2019 and December 31,
2018 |
|
— |
|
|
|
— |
|
Common
stock; $.001 par value; 200,000 shares authorized; 10,637 and
10,636 shares issued and outstanding at March 31, 2019 and December
31, 2018, respectively |
|
11 |
|
|
|
11 |
|
Additional paid-in capital |
|
841,219 |
|
|
|
840,751 |
|
Accumulated other comprehensive loss |
|
(21 |
) |
|
|
(270 |
) |
Accumulated deficit |
|
(888,454 |
) |
|
|
(880,515 |
) |
Total
stockholders’ deficit |
|
(47,245 |
) |
|
|
(40,023 |
) |
Total
liabilities and stockholders’ deficit |
$ |
290,183 |
|
|
$ |
302,147 |
|
VIVUS, INC.CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS(In thousands, except per
share data)(Unaudited)
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
March 31, |
|
2019 |
|
2018 |
Revenue: |
|
|
|
|
|
|
|
Net
product revenue |
$ |
13,497 |
|
|
$ |
9,632 |
|
Supply
revenue |
|
1,604 |
|
|
|
1,683 |
|
Royalty
revenue |
|
1,045 |
|
|
|
585 |
|
Total
revenue |
|
16,146 |
|
|
|
11,900 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of
goods sold (excluding amortization) |
|
4,308 |
|
|
|
2,630 |
|
Amortization of intangible assets |
|
3,638 |
|
|
|
91 |
|
Selling,
general and administrative |
|
9,818 |
|
|
|
10,068 |
|
Research
and development |
|
2,469 |
|
|
|
1,403 |
|
Total
operating expenses |
|
20,233 |
|
|
|
14,192 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(4,087 |
) |
|
|
(2,292 |
) |
|
|
|
|
|
|
|
|
Interest
expense and other expense, net |
|
3,870 |
|
|
|
8,349 |
|
Loss before income
taxes |
|
(7,957 |
) |
|
|
(10,641 |
) |
(Benefit) provision for
income taxes |
|
(8 |
) |
|
|
12 |
|
Net
loss |
$ |
(7,949 |
) |
|
$ |
(10,653 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share: |
$ |
(0.75 |
) |
|
$ |
(1.00 |
) |
Shares used in per
share computation: |
|
|
|
|
|
|
|
Basic and
diluted |
|
10,637 |
|
|
|
10,601 |
|
|
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 |
|
March 31, |
|
2019 |
|
|
2018 |
|
Net loss |
$ |
(7,949 |
) |
|
$ |
(10,653 |
) |
Adjustments: |
|
|
|
|
|
Interest
expense and other expense, net |
|
3,870 |
|
|
|
8,349 |
|
Depreciation of fixed assets |
|
37 |
|
|
|
66 |
|
Amortization of intangible assets |
|
3,638 |
|
|
|
91 |
|
Share-based compensation expense |
|
468 |
|
|
|
925 |
|
Provision
for (benefit from) income taxes |
|
(8 |
) |
|
|
12 |
|
Non-GAAP
EBITDA and Non-GAAP recurring EBITDA |
$ |
56 |
|
|
$ |
(1,210 |
) |
|
|
|
|
|
|
|
|
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, non-recurring restructuring and transaction
costs and the one-time impact of changes in accounting estimates or
the impact of new accounting standards. 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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