VIVUS, Inc. (Nasdaq: VVUS) (the “Company”), a
biopharmaceutical company, today reported financial results for the
quarter and fiscal year ended December 31, 2019 and provided a
business update.
“Fiscal year 2019 represents our first full year
of operating results as a fully integrated business and clinical
team,” said John Amos, VIVUS’ Chief Executive Officer. “In
2019, our team delivered nearly $70 million of revenue, a 7%
increase compared to 2018, increased adjusted EBITDA 7% compared to
2018 and reduced our net loss by $5.5 million, a 15%
decrease. VIVUS is now six quarters through a 10-quarter
turnaround, and we are pleased with our progress towards achieving
our goals.”
Recent Business Highlights
- Completes Enrollment of
Phase 4 Safety and Efficacy Study of
Qsymia® in AdolescentsIn
March 2020, completed patient enrollment in VIVUS’ Phase 4 clinical
study designed to evaluate the safety and efficacy of Qsymia
(phentermine and topiramate extended-release) capsules CIV in obese
adolescents between the ages of 12 and 17 years.
- Qsymia Launches in South
KoreaIn February 2020, VIVUS announced that its Korean
marketing partner, Alvogen Malta Operations (ROW) Ltd., has
launched Qsymia in the Republic of Korea. VIVUS will receive a $2
million payment tied to the commercial launch of Qsymia.
- Results of “Toolbox Trial”
Demonstrating Qsymia’s Effectiveness Are PublishedIn
January 2020, The University of Colorado announced the publication
of new results from its Toolbox Trial, a real-world clinical trial
conducted in urban safety-net primary care clinics offering
patients a “toolbox” of cost-effective weight management tools. The
study, published in the Journal of General Internal Medicine,
found that a higher proportion of subjects who initially selected
Qsymia from the toolbox or added it to their weight management
plans during the study period achieved at least a 5% weight loss
compared with subjects who never used Qsymia.
- New Clinical Data Released
Demonstrating that Qsymia is Effective at Reducing Binge Eating in
Patients with Binge-Eating Disorder or Bulimia NervosaIn
November 2019, the results of a clinical study were published
demonstrating that patients with binge-eating disorder or bulimia
nervosa receiving Qsymia had a significant reduction in binge day
frequency compared with placebo over four weeks and was well
tolerated in these patient populations. The study results appear
online in the International Journal of Eating Disorders.
- FDA Approves Improved
PANCREAZE FormulationIn February 2020, the U.S. Food and
Drug Administration (FDA) approved the supplemental New Drug
Application (sNDA) for an improved formulation of PANCREAZE®
(pancrelipase) Delayed Release Capsules that extends the shelf life
to 36 months across all PANCREAZE dosages.
Fourth Quarter 2019 vs Third Quarter
2019 Financial Results
Revenue consisted of the following:
|
|
(In thousands)Three Months
Ended |
|
|
|
December 31,2019 |
|
September 30,2019 |
|
Qsymia net product revenue |
|
$ |
9,750 |
|
$ |
9,583 |
|
PANCREAZE/PANCREASE MT, net product revenue |
|
|
5,849 |
|
|
5,266 |
|
Milestone revenue |
|
|
— |
|
|
2,500 |
|
Supply revenue |
|
|
1,186 |
|
|
64 |
|
Royalty revenue |
|
|
469 |
|
|
557 |
|
Total revenue |
|
$ |
17,254 |
|
$ |
17,970 |
|
Qsymia net product revenue was $9.8 million and
$9.6 million in the fourth and third quarters of 2019,
respectively. The Company continues to migrate Qsymia patients from
the traditional retail pharmacy model to the Qsymia Advantage
Program that improves access to Qsymia through, among other things,
direct-to-patient distribution and improved pricing. During the
fourth quarter of 2019, 31% of Qsymia scripts were dispensed
through the Qsymia Advantage Program’s Direct-to-Patient model, up
from 22% and 8% in the third and second quarters of 2019,
respectively. In the fourth quarter of 2019, the Company
experienced a seasonal drop in scripts to 83,116 compared to 85,899
in the third quarter of 2019, a decrease of 3%. This compares to a
7% decrease between the same periods in 2018.
PANCREAZE® net product revenue was $5.8 million
and $5.3 million in the fourth and third quarters of 2019,
respectively. The results in the fourth and third quarters of 2019
included $0.9 million and $0.1 million of Canadian sales of
PANCREASE® MT, respectively. The Company began to recognize sales
revenue from Canadian sales in the third quarter of 2019. Total
U.S. scripts were 5,735 and 5,777 during the fourth and third
quarters of 2019, respectively. In the U.S., the Company has a
dedicated 10-person sales force, sampling program, full patient
support program, a plan for investigator-sponsored trials in
oncology, and a digital marketing campaign strategy, along with
several other enhancements.
Milestone revenue in the third quarter of 2019
represented the payment received related to Alvogen, VIVUS’ Korean
marketing partner, obtaining marketing approval for Qsymia from the
South Korea Ministry of Food and Drug Safety.
Supply revenue in the fourth quarter of 2019
consisted of sales of Qsymia to Alvogen to support the recent
launch of Qsymia in South Korea. Prior to the fourth quarter,
supply revenue consisted of sales of STENDRA®/SPEDRATM to the
Company’s licensees for sales in the EU and U.S. Supply revenue
varies based on the timing of orders from the Company’s licensees
and consists of minimum order requirements and such purchases do
not correspond to end user demand.
Royalty revenue was $0.5 million and $0.6
million in the fourth and third quarters of 2019, respectively.
These amounts consisted of royalties earned on SPEDRA European
revenues.
Total cost of goods sold, excluding
amortization, was $4.0 million and $3.0 million in the fourth and
third quarters of 2019, respectively. The increase was primarily
due to the increase in Qsymia and PANCREAZE product sales as well
as the increase in supply revenue over the third quarter.
Amortization of intangible assets was $3.6
million in both the fourth and third quarters of 2019. The amount
primarily consisted of amortization expense of costs capitalized
related to the acquisition of PANCREAZE.
Selling, general and administrative expense was
$10.9 million and $9.2 million in the fourth and third quarters of
2019, respectively, and included selling and marketing expense of
$4.3 million and $4.5 million, respectively. The increase in
general and administrative costs was primarily due to the Company
incurring $1.9 million of severance costs associated with the
elimination of two officers.
Research and development expense was $2.4
million and $3.3 million in the fourth and third quarters of 2019,
respectively. In 2019, research and development efforts primarily
consisted of activities related to the Qsymia adolescent and
efficacy study (OB-0403), PANCREAZE post-marketing requirements
assumed from Janssen and PANCREAZE product improvement
initiatives.
Total interest and other expense was $2.9
million and $9.9 million in the fourth and third quarters of 2019,
respectively. The decrease in interest expense in the fourth
quarter was primarily a result of prepayment premiums related to
the reduction in debt balances incurred in the third quarter.
Net loss for the fourth and third quarters of
2019 was $6.5 million and $11.1 million, respectively. Cash and
cash equivalents were $32.6 million at December 31, 2019.
Non-GAAP EBITDA for the fourth and third
quarters of 2019 was $0.6 million and $3.0 million, respectively.
Recurring non-GAAP EBITDA was $2.3 million and $1.2 million for the
fourth and third quarters of 2019, respectively. In the fourth
quarter, non-GAAP EBITDA was adjusted to remove the severance
expense related to the elimination of two officers during the
quarter and the third quarter was adjusted to exclude the Qsymia
milestone revenue and certain professional fees related to the
Company’s debt buyback.
Conference Call Details
VIVUS will hold a conference call and an
audio webcast to provide a business update and to discuss fourth
quarter 2019 financial results today, March 3, 2020, beginning
at 4:30 PM Eastern Time.
To listen via webcast, please visit
http://ir.vivus.com/, or by clicking here.
To listen via phone, please use the dial in
information provided below.
Dial in Details:Toll-Free: (877)
359-2916International: (224) 357-2386Passcode: 6791889
The webcast replay and slide presentation will
be available in the Events and Presentations section on
the VIVUS website for 30 days.
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 subsidiaries 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 biopharmaceutical 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 our outstanding balance of the
convertible notes due in May 2020; risk and uncertainties related
to the timing, strategy, structure and success of our capital
raising efforts; 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, including our ability to improve
patient access to PANCREAZE; risks and uncertainties related to our
commercialization of PANCREAZE as a new product and our 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, including
our ability to improve patient and physician access to Qsymia;
risks and uncertainties related to the impact of promotional
programs for Qsymia on our net product revenue and net income
(loss) in future periods; risks and uncertainties related to our
ability to sell through the Qsymia retail pharmacy network and the
Qsymia Advantage Program; risks and uncertainties related to the
timing of initiation and completion of the post-approval clinical
studies required as part of the approval of Qsymia by the U.S. Food
and Drug Administration (“FDA”), including the Phase 4
post-marketing study of Qsymia in obese adolescents; risks and
uncertainties related to the response from FDA to any data and/or
information relating to post-approval clinical studies required for
Qsymia; risks and uncertainties related to the impact of any
possible future requirement to provide further analysis of
previously submitted clinical trial data; risks and uncertainties
related to the design and outcome of any clinical study required by
FDA to expand the Qsymia label; 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
demonstrate through clinical testing the quality, safety, and
efficacy of our current or future investigational drug candidates
or approved products; 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 certain
concerned member states in Europe relating to the pending
decentralized Marketing Authorization Application, the timing and
scope of the assessment by such Concerned Member State health
authorities of our Marketing Authorization Application, and
ultimately the decision of such Concerned Member State health
authorities whether to grant Marketing Authorization for Qsymia in
such EU countries; 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, 2019 as filed on March 3, 2020, 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.Mark OkiChief Financial
Officeroki@vivus.com650-934-5200
Investor Relations: Lazar FINN PartnersDavid
CareySenior Partnerdavid.carey@finnpartners.com212-867-1768
|
|
|
|
|
|
VIVUS, INC.CONDENSED CONSOLIDATED
BALANCE SHEETS(In thousands, except par
value) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
2019 |
|
2018 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
32,649 |
|
|
$ |
30,411 |
|
Available-for-sale securities |
|
— |
|
|
|
80,838 |
|
Accounts receivable, net |
|
22,338 |
|
|
|
25,608 |
|
Inventories |
|
33,679 |
|
|
|
23,132 |
|
Prepaid expenses and other current assets |
|
8,134 |
|
|
|
7,538 |
|
Total current assets |
|
96,800 |
|
|
|
167,527 |
|
Property and equipment,
net |
|
233 |
|
|
|
341 |
|
Right-of-use assets |
|
1,135 |
|
|
|
— |
|
Intangible and other
non-current assets |
|
120,140 |
|
|
|
134,279 |
|
Total assets |
$ |
218,308 |
|
|
$ |
302,147 |
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
7,726 |
|
|
$ |
8,921 |
|
Accrued and other liabilities |
|
32,398 |
|
|
|
33,044 |
|
Deferred revenue |
|
1,249 |
|
|
|
1,235 |
|
Current portion of lease liability |
|
767 |
|
|
|
— |
|
Current portion of long-term debt |
|
183,006 |
|
|
|
— |
|
Total current liabilities |
|
225,146 |
|
|
|
43,200 |
|
Long-term debt, net of current portion |
|
58,721 |
|
|
|
294,446 |
|
Deferred revenue, net of current portion |
|
3,063 |
|
|
|
4,290 |
|
Lease liability, net of current portion |
|
602 |
|
|
|
— |
|
Non-current accrued and other liabilities |
|
— |
|
|
|
234 |
|
Total liabilities |
|
287,532 |
|
|
|
342,170 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
Preferred stock; $.001 par value; 5,000 shares authorized; no
shares issued and outstanding at December 31, 2019 and
December 31, 2018, respectively |
|
— |
|
|
|
— |
|
Common stock; $.001 par value; 200,000 shares
authorized; 10,643 and 10,636 shares issued and outstanding at
December 31, 2019 and 2018, respectively |
|
11 |
|
|
|
11 |
|
Additional paid-in capital |
|
842,808 |
|
|
|
840,751 |
|
Accumulated other comprehensive loss |
|
(35 |
) |
|
|
(270 |
) |
Accumulated deficit |
|
(912,008 |
) |
|
|
(880,515 |
) |
Total stockholders’ deficit |
|
(69,224 |
) |
|
|
(40,023 |
) |
Total liabilities and stockholders’ deficit |
$ |
218,308 |
|
|
$ |
302,147 |
|
|
VIVUS, INC.CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS(In thousands, except per
share data)(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended |
|
December 31,2019 |
|
September 30, 2019 |
Revenue: |
|
|
|
|
|
Net product revenue |
$ |
15,599 |
|
|
$ |
14,849 |
|
Milestone revenue |
|
— |
|
|
|
2,500 |
|
Supply revenue |
|
1,186 |
|
|
|
64 |
|
Royalty revenue |
|
469 |
|
|
|
557 |
|
Total revenue |
|
17,254 |
|
|
|
17,970 |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Cost of goods sold (excluding amortization) |
|
3,970 |
|
|
|
3,016 |
|
Amortization of intangible assets |
|
3,638 |
|
|
|
3,638 |
|
Selling, general and administrative |
|
10,944 |
|
|
|
9,207 |
|
Research and development |
|
2,380 |
|
|
|
3,266 |
|
Total operating expenses |
|
20,932 |
|
|
|
19,127 |
|
|
|
|
|
|
|
Loss from operations |
|
(3,678 |
) |
|
|
(1,157 |
) |
|
|
|
|
|
|
Interest expense and other expense, net |
|
2,852 |
|
|
|
9,911 |
|
Loss before income taxes |
|
(6,530 |
) |
|
|
(11,068 |
) |
Provision for income
taxes |
|
17 |
|
|
|
4 |
|
Net loss |
$ |
(6,547 |
) |
|
$ |
(11,072 |
) |
|
|
|
|
|
|
Basic and diluted net loss per
share: |
$ |
(0.61 |
) |
|
$ |
(1.04 |
) |
Shares used in per share
computation: |
|
|
|
|
|
Basic and diluted |
|
10,646 |
|
|
|
10,643 |
|
|
VIVUS, INC.GAAP to NON-GAAP
RECONCILIATIONNET LOSS to EBITDA and RECURRING
EBITDA(In
thousands)(Unaudited) |
|
A reconciliation between net loss on a GAAP basis, non-GAAP EBITDA
and non-GAAP recurring EBITDA for the fourth and third quarters of
2019 is as follows: |
|
|
Three Months Ended |
|
December
31, |
|
September 30, |
2019 |
2019 |
Net loss |
$ |
(6,547 |
) |
|
$ |
(11,072 |
) |
Adjustments: |
|
|
|
|
|
Interest expense and other expense, net |
|
2,852 |
|
|
|
9,911 |
|
Depreciation of fixed assets |
|
40 |
|
|
|
36 |
|
Amortization of intangible assets |
|
3,638 |
|
|
|
3,638 |
|
Share-based compensation expense |
|
608 |
|
|
|
483 |
|
Provision for income taxes |
|
17 |
|
|
|
4 |
|
Non-GAAP EBITDA |
$ |
608 |
|
|
$ |
3,000 |
|
Milestone revenue |
|
— |
|
|
|
(2,500 |
) |
Fees from debt buy down |
|
— |
|
|
|
656 |
|
Severance expense |
|
1,645 |
|
|
|
— |
|
Non-GAAP recurring EBITDA |
$ |
2,253 |
|
|
$ |
1,156 |
|
|
VIVUS, INC.GAAP to NON-GAAP
RECONCILIATIONNET LOSS to ADJUSTED
EBITDA(In
thousands)(Unaudited) |
|
A reconciliation between net loss on a GAAP basis and adjusted
non-GAAP EBITDA for the years ended December 31, 2019 and 2019 is
as follows: |
|
|
Year Ended December 31, |
|
2019 |
|
2018 |
Net
loss |
$ |
(31,503 |
) |
|
$ |
(36,950 |
) |
Adjustments: |
|
|
|
|
|
Interest expense and other expense, net |
|
20,513 |
|
|
|
33,419 |
|
Gain on extinguishment of debt |
|
— |
|
|
|
1,427 |
|
Depreciation of fixed assets |
|
150 |
|
|
|
235 |
|
Amortization of intangible assets |
|
14,552 |
|
|
|
8,640 |
|
Share-based compensation expense |
|
2,026 |
|
|
|
3,285 |
|
Provision for income taxes |
|
21 |
|
|
|
52 |
|
Non-GAAP EBITDA |
$ |
5,759 |
|
|
$ |
10,108 |
|
|
|
|
|
|
|
Non-recurring and discretionary spending |
|
|
|
|
|
Milestone revenue |
|
(2,500 |
) |
|
|
— |
|
One-time expenses |
|
2,301 |
|
|
|
2,034 |
|
Gain on extinguishment of debt |
|
— |
|
|
|
(1,427 |
) |
Incremental sales and marketing |
|
3,998 |
|
|
|
— |
|
Research and development |
|
5,680 |
|
|
|
3,563 |
|
Adjusted Non-GAAP EBITDA |
$ |
15,238 |
|
|
$ |
14,278 |
|
|
|
|
|
|
|
|
|
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 expense 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. We define Adjusted non-GAAP
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 and discretionary incremental sales and
marketing expenses and discretionary research and development
expenses.
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