VIVUS Reports Fourth Quarter and Year-End 2013 Financial Results
MOUNTAIN VIEW, Calif., Feb. 24, 2014 (GLOBE NEWSWIRE) -- VIVUS, Inc.
(Nasdaq:VVUS), a biopharmaceutical company commercializing Qsymia^®
(phentermine and topiramate extended-release) capsules CIV for the treatment
of obesity, today provided a business update and reported its financial
results for the fourth quarter and year ended December 31, 2013.
*On November 13, 2013, we announced that the United States Patent and
Trademark Office had issued U.S. Patent Nos. 8,580,298, covering
compositions of Qsymia, and 8,580,299, covering methods for effecting
weight loss using Qsymia. The newly issued patents are assigned to VIVUS
and are expected to extend patent exclusivity for Qsymia in the U.S. to
*On November 21, 2013, we announced our support for new clinical practice
guidelines developed by the American Heart Association, American College
of Cardiology and The Obesity Society, in conjunction with the National
Heart, Lung and Blood Institute, urging healthcare providers to take an
active role in helping overweight or obese patients achieve and maintain a
healthy body weight. The guidelines also state that obesity medication can
be considered as an adjunct to lifestyle intervention to help appropriate
patients (individuals with BMI ≥30 or BMI ≥27 with at least one
obesity-associated comorbid condition) achieve their weight loss goals. A
concurrent publication in the Journal of the American Medical Association
by researchers from the National Institutes of Health found that
medications approved for long-term obesity treatment, when used as an
adjunct to lifestyle intervention, lead to an increased likelihood of
achieving clinically meaningful weight loss.
*On December 12, 2013, we announced a License and Commercialization
Agreement with Sanofi to commercialize avanafil on an exclusive basis in
Africa, the Middle East, Turkey, and the Commonwealth of Independent
States (CIS) including Russia. Sanofi will be responsible for obtaining
regulatory approval in its territories. Under the terms of the agreement,
VIVUS is eligible to receive up to $61 million in upfront payments,
regulatory and sales milestones. VIVUS will also receive escalating
royalties based on net sales over the life of the agreement.
*On January 2, 2014, we disclosed that we had entered into a Rebate
Agreement with CaremarkPCS Health, LLC, a pharmacy benefit manager, under
which Qsymia will be available as either a preferred brand (tier-2) or
non-preferred brand (tier-3) with copayments ranging from $15.00 to $75.00
for those members of Caremark whose benefit design includes obesity drug
coverage. This agreement helped to increase to 43% the percentage of U.S.
commercial lives with access to Qsymia at tier-3 or better.
*On January 14, 2014, we announced a collaboration with Aetna, one of the
nation's leading diversified health care benefits companies, to integrate
Qsymia into a pilot program designed to evaluate the benefits of
prescription medication combined with lifestyle support for weight loss.
The pilot program is currently being offered to self-insured plan
sponsors, and includes outreach to appropriate members and health care
providers regarding covered options. It is expected to provide insight
regarding impact on health outcomes, workplace productivity and the
potential for reductions in medical costs. The program is projected to run
through year-end 2014.
*On January 21, 2014, we announced that the U.S. Food and Drug
Administration had accepted a supplemental application that proposes to
revise the STENDRA™ (avanafil) prescribing information with efficacy and
safety information from Study TA-501, entitled "A Randomized,
Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand
Treatment of Men with Erectile Dysfunction." VIVUS had previously
announced positive results from this multicenter, placebo-controlled study
designed to assess the efficacy of two dosage strengths of STENDRA
approximately 15 minutes after dosing. The PDUFA date for the supplemental
filing is September 20, 2014.
"The market for obesity pharmacotherapeutics is developing, and we are making
progress in key areas such as physician education, reimbursement coverage and
guidelines for treatment," stated Seth H. Z. Fischer, chief executive officer.
"While our financial results for this most recent quarter and for 2013 overall
were disappointing, we believe in the long-term prospects for this market as
we continue our efforts to make Qsymia the drug of choice for patients that
are obese or overweight with weight-related medical conditions."
Fourth Quarter Financial Results
For the fourth quarter of 2013, total net product revenue was $9.2 million, of
which $7.7 million was from sales of Qsymia and the remaining amount was from
STENDRA and SPEDRA. In addition, we recognized $34.8 million in license
revenue under our commercialization agreements with Auxilium and Sanofi
related to STENDRA or SPEDRA. In September 2012, we began distributing Qsymia
to the certified home delivery pharmacies in our network, and Qsymia became
available in retail pharmacies in July 2013. For the fourth quarter of 2012,
net product revenue from sales of Qsymia was approximately $2.0 million.
For the fourth quarter of 2013, net loss was $17.2 million, or $0.17 net loss
per share, as compared to a net loss of $56.7 million, or $0.56 net loss per
share, during the fourth quarter of 2012. The decreased net loss for the
fourth quarter of 2013, as compared to the fourth quarter of 2012, was
primarily attributable to license revenue from the commercialization
agreements with Auxilium and Sanofi related to STENDRA and SPEDRA, higher net
product revenue, and a decrease of $13.7 million in selling, general and
administrative expenses during the quarter, offset by increased net interest
and other expense of $8.4 million and $8.0 million of non-recurring charges
during the fourth quarter of 2013 related to the previously announced cost
For the fourth quarter of 2013, there were approximately 124,000 Qsymia
prescriptions dispensed, an increase of approximately 14% compared to the
third quarter of 2013. Prescription volume for the fourth quarter was impacted
by the holidays in November and December.
Year End 2013 Financial Results
For the year ended December 31, 2013, total net product revenue was $25.2
million, of which $23.7 million was from sales of Qsymia and the remaining
amount was from STENDRA. Total license revenue was $55.8 million from the
license and commercialization agreements for STENDRA and SPEDRA.
For the year ended December 31, 2013, net loss was $174.5 million, or $1.72
net loss per share, as compared to a net loss of $139.9 million, or $1.42 net
loss per share, for the year ended December 31, 2012. The increase in net loss
was primarily attributable to higher selling, general and administrative
expenses related to commercialization activities for Qsymia. Included in the
net loss for the year ended December 31, 2013 was $32.7 million in
non-recurring charges related to the proxy contest in connection with our 2013
Annual Meeting of Stockholders and associated severance charges, including
$14.1 million of non-cash share-based compensation expense, a total charge of
$10.2 million for Qsymia inventories on hand in excess of demand, plus a
purchase commitment fee for Qsymia, and $20.2 million of net interest and
other expense primarily related to the long-term debt incurred in April and
May of 2013.
Cash, Cash Equivalents and Available-for-Sale Securities
Cash, cash equivalents and available-for-sale securities (cash) totaled $343.3
million at December 31, 2013, as compared to $214.6 million at December 31,
2012. The increase of $128.7 million includes cash provided by financing
activities, including net proceeds of $48.4 million from the Senior Secured
Notes with BioPharma and $241.8 million from the Convertible Notes, less cash
used to purchase capped calls of $34.7 million, in addition to $61.6 million
in net upfront payments received from the three license and commercialization
agreements for STENDRA and SPEDRA, partially offset by cash used in operating
and investing activities.
Note to Investors
As previously announced, VIVUS will hold a conference call and an audio
webcast to discuss the fourth quarter and year ended December 31, 2013
financial results today, February 24, 2014, beginning at 1:30PM Pacific Time.
Investors may listen to this call by dialing 1-877-359-2916 in the U.S. and
++224-357-2386 outside the U.S. A webcast replay will be available for 30 days
and may be accessed at http://ir.vivus.com/.
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.
Important Safety Information
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 (MAOIs); or in patients with hypersensitivity to
sympathomimetic amines, topiramate, or any of the inactive ingredients in
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
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.
STENDRA (avanafil) is approved in the U.S. by the FDA for the treatment of
erectile dysfunction. Auxilium Pharmaceuticals, Inc. has exclusive marketing
rights to STENDRA in the U.S. and Canada.
STENDRA will be available through retail and mail order pharmacies. Auxilium
plans to offer programs that will help patients with out-of-pocket costs.
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.
VIVUS has granted an exclusive license to Sanofi to commercialize avanafil in
Africa, the Middle East, Turkey, and the Commonwealth of Independent States
(CIS) including Russia.
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
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
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
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
Please see full patient prescribing information for STENDRA (50 mg, 100 mg,
200 mg) tablets.
VIVUS is a biopharmaceutical company commercializing and developing
innovative, next-generation therapies to address unmet needs in obesity, sleep
apnea, diabetes and sexual health. For more information about the company,
please visit www.vivus.com.
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 the extension of patent exclusivity for Qsymia in the
U.S.; risks and uncertainties related to upfront payments, regulatory and
sales milestones, as well as royalties, under the License and
Commercialization Agreement with Sanofi; risks and uncertainties related to
the insight provided by the Aetna pilot program on the impact on health
outcomes, workplace productivity and the potential for reductions in medical
costs, including the timing of the program; risks and uncertainties related to
the FDA acceptance of a supplemental application that proposes to revise the
STENDRA prescribing information to include recent study results; and risk and
uncertainties related to the long-term prospects for the obesity market, as
well as our continuing efforts to make Qsymia the drug of choice in this
market. 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's Form 10-K for the year
ending December 31, 2012, as amended by the Form 10-K/A filed on April 30,
2013 and by the Form 10-K/A filed on June 12, 2013, and periodic reports filed
with the Securities and Exchange Commission. VIVUS does not undertake an
obligation to update or revise any forward-looking statements.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three Months Ended Years Ended
December 31 December 31 December 31 December 31
2013 2012 2013 2012*
(unaudited) (unaudited) (unaudited)
Net product revenue $9,219 $1,971 $25,244 $2,012
License and other 34,838 -- 55,838 --
Total revenue 44,057 1,971 81,082 2,012
Cost of goods sold 3,165 183 4,868 187
Inventory impairment -- -- 10,225 0
and commitment fee
Research and 4,994 7,758 29,677 32,065
Selling, general and 36,569 50,314 158,235 109,665
Non-recurring charges 8,024 -- 32,691 --
Total operating 52,752 58,255 235,696 141,917
Loss from operations (8,695) (56,284) (154,614) (139,905)
Interest and other 8,418 (69) 20,235 (199)
expense (income), net
Loss from continuing
operations before (17,113) (56,215) (174,849) (139,706)
Provision for income 51 14 97 27
Loss from continuing (17,164) (56,229) (174,946) (139,733)
(Loss) income from -- (430) 490 (148)
Net loss $(17,164) $(56,659) $(174,456) $(139,881)
Basic and diluted net
income (loss) per
Continuing operations $(0.17) $(0.56) $(1.72) $(1.42)
Discontinued operations -- -- -- --
Net loss per share $(0.17) $(0.56) $(1.72) $(1.42)
Shares used in per
Basic and diluted 102,379 100,626 101,174 98,289
*The Condensed Consolidated Statement of Operations at December 31, 2012 has
been derived from the Company's audited financial statements at that date.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value amount)
December 31 December 31
Cash and cash equivalents $103,262 $58,605
Available-for-sale securities 240,024 155,981
Accounts receivable, net 12,214 2,778
Inventories 48,503 25,353
Prepaid expenses and other assets 19,938 19,159
Total current assets 423,941 261,876
Property and equipment, net 1,954 1,951
Non-current assets 5,901 287
Total assets $431,796 $264,114
Accounts payable $10,759 $25,375
Accrued and other liabilities 23,993 14,680
Deferred revenue 17,255 1,150
Total current liabilities 52,007 41,205
Long term debt 213,106 --
Deferred revenue-net of current portion 10,360 --
Non-current accrued and other liabilities 2,954 --
Total liabilities 278,427 41,205
Commitments and contingencies
Common stock and additional paid-in capital 813,905 709,022
Accumulated other comprehensive income 66 33
Accumulated deficit (660,602) (486,146)
Total stockholders' equity 153,369 222,909
Total liabilities and stockholders' equity $431,796 $264,114
*The Condensed Consolidated Balance Sheet at December 31, 2012 has been
derived from theCompany's audited financial statements at that date.
CONTACT: VIVUS, Inc.
Dana B. Shinbaum
Corporate Development &
Investor Relations: The Trout Group
Senior Vice President
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