CAMPBELL, CA --(Marketwired - May 03, 2017) - VIVUS,Inc. (NASDAQ: VVUS) (the "Company"), a biopharmaceutical company committed to the development and commercialization
of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today reported its
financial results for the quarter ended March 31, 2017 and provided a business update. Net loss for the 2017 first quarter was
$1.1 million, as compared to a net loss of $12.7 million in the first quarter of 2016. Cash, cash equivalents and
available-for-sale securities were $260.2 million at March 31, 2017.
"We continue our efforts to reshape VIVUS' business model," said Seth H. Z. Fischer, VIVUS' Chief Executive Officer. "We have
begun the formulation phase of our development program for tacrolimus as a treatment of Pulmonary Arterial Hypertension and
expect to submit our request for a pre-IND meeting with FDA in the second half of 2017."
Mr. Fischer continued, "In addition, we are evaluating other product development opportunities to utilize our cash resources,
which could come in the form of a license, a co-development agreement, a merger or acquisition or other form."
Business Update
- In March 2017, VIVUS reacquired the commercial rights for STENDRA in Africa, the Middle East, Turkey and the Commonwealth
of Independent States, including Russia, from Sanofi.
- In March 2017, VIVUS engaged Aquilo Partners to assist us with our strategic process in identifying, evaluating and
acquiring new product pipeline programs.
- In January 2017, VIVUS acquired exclusive, worldwide rights for the development and commercialization of tacrolimus and
ascomycin for the treatment of Pulmonary Arterial Hypertension (PAH) and related vascular diseases from Selten Pharma, Inc. For
2017, our goals for this program will be to develop or in-license a proprietary formulation for tacrolimus and have a pre-IND
meeting with FDA to obtain an IND and identify a potential clinical pathway to approval.
- In January 2017, VIVUS granted a license to Hetero to manufacture and commercialize the generic version of STENDRA
described in Hetero's ANDA filing in the United States effective no earlier than October 29, 2024.
- In January 2017, VIVUS promoted Deborah Larsen to the newly created position of Chief Commercial Officer.
Financial Results
Total revenue, net for the first quarters of 2017 and 2016, was $27.0 million and $15.3 million, respectively. Revenue
consisted of the following:
|
|
Three Months Ended |
|
|
March 31, |
|
|
2017 |
|
2016 |
Qsymia, net product revenue |
|
$ |
17,620 |
|
$ |
12,412 |
License and milestone revenue |
|
|
5,000 |
|
|
- |
STENDRA/SPEDRA supply revenue |
|
|
3,812 |
|
|
1,526 |
STENDRA/SPEDRA royalty revenue |
|
|
580 |
|
|
1,386 |
|
Total revenue |
|
$ |
27,012 |
|
$ |
15,324 |
In the first quarter of 2017, we changed our revenue recognition methodology for Qsymia sales from a "sell-through" method to
a "sell-in" method. This change resulted in the Company recognizing $7.3 million of net product revenue related to units of
Qsymia shipped prior to January 1, 2017.
Approximately 102,000 and 116,000 Qsymia prescriptions were dispensed in the first quarters of 2017 and 2016, respectively.
Due to our switch to a "sell-in" model, revenue will be based on units shipped to the wholesaler rather than prescriptions
dispensed in a given period. In the first quarter of 2017, we shipped approximately 89,000 units of Qsymia to the wholesalers.
The "sell-in" model could result in higher volatility of Qsymia sales compared to those historically reported.
In the first quarter of 2017, we also recognized revenue related to a one-time $5.0 million payment for a license to certain
clinical data.
Total cost of goods sold, excluding inventory impairment, was $6.2 million and $3.7 million in the first quarters of 2017 and
2016, respectively. The change in cost of goods sold was due to changes in net product and supply revenue in the respective
periods and the sales mix between Qsymia and STENDRA/SPEDRA.
General and administrative expense was $6.0 million and $7.5 million for the first quarters of 2017 and 2016, respectively.
The decrease was primarily due to VIVUS' continued cost control efforts.
Selling and marketing expense for the commercialization of Qsymia totaled $5.5 million and $7.6 million in the first quarters
of 2017 and 2016, respectively. The total decrease was the result of the realignment of our sales force, refinement of our
marketing and promotional programs, and continued cost control initiatives.
Research and development expense was $2.2 million and $1.0 million in the first quarters of 2017 and 2016, respectively. The
increase was due primarily to the license fees paid to Selten for the development of tacrolimus and ascomycin for the treatment
of PAH.
Note to Investors
As previously announced, VIVUS will hold a conference call and an audio webcast to discuss the quarter ended March 31, 2017
financial results and to provide a business update today, May 3, 2017, beginning at 4:30PM Eastern Time. Investors may listen to
this call by dialing toll-free (877) 359-2916 in the U.S. and (224) 357-2386 from outside the U.S. The webcast link is: http://edge.media-server.com/m/p/76esnfqz. The audience passcode
is 9384 6816. A webcast replay will be available for 30 days and may be accessed at http://ir.vivus.com/.
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.
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; 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 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
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.
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, including the evaluation of development opportunities;
risks and uncertainties related to our ability to successfully commercialize Qsymia; risks and uncertainties related to our
ability to successfully develop or acquire a proprietary formulation of tacrolimus as a precursor to the clinical development
process; risks and uncertainties related to our ability to identify, acquire and develop new product pipeline candidates; risks
and uncertainties related to 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,
including the former Sanofi territories; risks and uncertainties related to Sanofi Chimie's ability to undertake manufacturing of
the avanafil active pharmaceutical ingredient and Sanofi Winthrop Industrie's ability to undertake manufacturing of the tablets
for avanafil; risks and uncertainties related to our ability to manage the supply chain for STENDRA/SPEDRA for our collaborators;
risks and uncertainties related to the ability of our partners to maintain regulatory approvals to manufacture and adequately
supply our products to meet demand; 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
protect our intellectual property and litigation in which we are involved or may become involved. 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, 2016 as filed on March 8, 2017, and as amended by the Form 10-K/A filed on April 26, 2017, 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. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
(In thousands, except per share data) |
(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2017 |
|
2016 |
Revenue: |
|
|
|
|
|
Net product revenue |
|
$ |
17,620 |
|
$ |
12,412 |
|
License and milestone revenue |
|
|
5,000 |
|
|
- |
|
Supply revenue |
|
|
3,812 |
|
|
1,526 |
|
Royalty revenue |
|
|
580 |
|
|
1,386 |
|
|
Total revenue |
|
|
27,012 |
|
|
15,324 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
|
6,167 |
|
|
3,704 |
|
Selling, general and administrative |
|
|
11,431 |
|
|
15,122 |
|
Research and development |
|
|
2,180 |
|
|
1,029 |
|
|
Total operating expenses |
|
|
19,778 |
|
|
19,855 |
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
7,234 |
|
|
(4,531) |
|
|
|
|
|
|
|
Interest expense and other expense, net |
|
|
8,302 |
|
|
8,161 |
Loss before income taxes |
|
|
(1,068) |
|
|
(12,692) |
(Benefit from) provision for income taxes |
|
|
(12) |
|
|
16 |
|
Net loss |
|
$ |
(1,056) |
|
$ |
(12,708) |
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.01) |
|
$ |
(0.12) |
Shares used in per share computation: |
|
|
|
|
|
|
|
Basic and diluted |
|
|
105,479 |
|
|
104,071 |
|
|
VIVUS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2017 |
|
2016* |
ASSETS |
|
(Unaudited) |
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
67,753 |
|
$ |
84,783 |
|
Available-for-sale securities |
|
|
192,477 |
|
|
184,736 |
|
Accounts receivable, net |
|
|
11,443 |
|
|
9,478 |
|
Inventories |
|
|
17,190 |
|
|
16,186 |
|
Prepaid expenses and other assets |
|
|
4,505 |
|
|
8,251 |
|
|
Total current assets |
|
|
293,368 |
|
|
303,434 |
Property and equipment, net |
|
|
738 |
|
|
788 |
Non-current assets |
|
|
1,379 |
|
|
1,554 |
|
|
Total assets |
|
$ |
295,485 |
|
$ |
305,776 |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,907 |
|
$ |
4,707 |
|
Accrued and other liabilities |
|
|
20,313 |
|
|
15,686 |
|
Deferred revenue |
|
|
1,505 |
|
|
19,174 |
|
Current portion of long-term debt |
|
|
9,311 |
|
|
8,708 |
|
|
Total current liabilities |
|
|
36,036 |
|
|
48,275 |
|
Long-term debt, net of current portion |
|
|
234,866 |
|
|
232,610 |
|
Deferred revenue, net of current portion |
|
|
6,232 |
|
|
6,449 |
|
Non-current accrued and other liabilities |
|
|
370 |
|
|
257 |
|
|
Total liabilities |
|
|
277,504 |
|
|
287,591 |
Commitments and contingencies |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
Common stock and additional paid-in capital |
|
|
832,582 |
|
|
831,855 |
|
Accumulated other comprehensive (loss) income |
|
|
(491) |
|
|
(616) |
|
Accumulated deficit |
|
|
(814,110) |
|
|
(813,054) |
|
|
Total stockholders' equity |
|
|
17,981 |
|
|
18,185 |
|
|
Total liabilities and stockholders' equity |
|
$ |
295,485 |
|
$ |
305,776 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* The Condensed Consolidated Balance Sheets have been derived from the Company's audited
financial statements at that date, as adjusted. |
|