VIVUS Inc. (NASDAQ:VVUS) Q2 2016 Earnings Conference Call August 4, 2016 4:30 PM ET
Mark Oki - Chief Financial Officer
Seth Fischer - Chief Executive Officer
Ryan Brinkman - JP Morgan
Good day, ladies and gentlemen and welcome to the VIVUS 2016 Second Quarter Financial Results and Business Update Teleconference. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder this teleconference is being recorded.
And now I will turn the program over to Mr. Mark Oki, Chief Financial Officer.
Thank you, Operator. Good afternoon everyone and welcome to today’s teleconference. Joining me today is Seth Fischer, VIVUS' Chief Executive Officer.
During this call, VIVUS will make certain statements that are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as anticipate, believe, estimate, expect, forecast, intend, likely, may, opportunity, plan, potential, predict and should, among others.
These forward-looking statements are based on VIVUS' current expectations, and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. Investors are advised to read the risk factors set forth in the VIVUS Form 10-K for the year ended December 31, 2015, as filed on March 9, 2016 and as amended by the Form 10-K/A filed on April 22, 2016, and periodic reports filed with the Securities and Exchange Commission, such as VIVUS Form 10-Q filed earlier today. VIVUS does not undertake an obligation to update or revise any forward-looking statements made on this call.
I’ll now turn the call over to Seth Fischer to provide a business update.
Thank you, Mark. Good afternoon and thank you for joining us. On our last call, I’ll update you on our business strategy evaluation, provide an update on our Qsymia commercialization activities and provide some perspective on obesity pharmacotherapy market.
In January, we engaged an advisor to assist us in an evaluation of our business strategy, most importantly the disposition of a commercialization right for STENDRA. In late 2015, Auxilium- Endo notified us of their intention of returning STENDRA to us effective June 30, 2016. We recently announced that we and Endo agreed to delay the transition of STENDRA, back to us until August 31, 2016.
We’ve worked closely with Endo and our consultants to understand STENDRA’s commercialization history, the competitive landscape in the erectile dysfunction or ED market, how STENDA’s clinical profile fits into this landscape and the market potential of STENDRA when actively promoted.
We learned that the ED market is promotionally sensitive and when STENDRA is actively promoted, supported by digital and print advertising, STENDRA was able to significantly increase its market share.
However, when the promotion ends, it quickly will lose any gains made. In interviews with healthcare providers that treat ED, we were in that STENDRA’s 15 minute of onset, the high selectivity STENDRA, resulting at lower side effects, the ability to be taken with food and drink and STENDRA’s lower pricing uniquely addresses unmet need among the patients being treated with competitive products.
We believe that STENDRA’s proven responsiveness to active promotion demonstrates its revenue potential and when commercialized through an efficient sales and marketing program can deliver significant value to the organization. We’re concurrently preparing to commercialize STENDRA in the U.S., while maintaining discussions to license or sell STENDRA’s U.S. commercialization rights.
On September 1, when the U.S. commercial rights are returned to us, we or a third party will assume STENDRA’s promotion activities from Auxilium. Our business strategy review has also outlined the importance of building a diverse company with a pipeline portfolio. As a result, we’re exploring opportunities to drive stockholder value through identifying both commercial and development stage products that leverage our know how and the infrastructure.
We continue to work closely with Menarini, our commercial alliance partner in Europe and Sanofi, our commercial alliance partner in the Middle East, Africa and the CIS countries to ensure the supply of Avanafil and provide assistance with their clinical, regulatory and commercial efforts.
SPEDRA, as Avanafil is known in the EU and other parts of the world, is available in Europe and retail pharmacies in 25 countries within the Menarini territory. Menarini has also secured the commercial rights from Mitsubishi Tanabe for certain parts of Asia.
We’re exploring our options to maximize the value of STENDRA commercial rights to territories we have yet partner, specifically Latin America and India. On June 30, 2106, we received notice from Hetero USA Inc. that has filed an Abbreviated New Drug Application or ANDA with the FDA for generic versions of all strengths of STENDRA tablets.
The notice from Hetero included a paragraph IV certification with respect to all of the patents listed for STENDRA in the FDA’s Orange Book on the date of the Company’s receipt of the notice. A paragraph IV certification is a certification by a generic applicant that patents covering the branded product are invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of the generic product.
On June 27, under provisions of the Hatch-Waxman Act, we filed a patent infringement suit against Hetero. With this filing a stay of approval of up to 30 months will be imposed by the FDA on Hetero’s ANDA. We intend to vigorously enforce its intellectual property rights, but cannot predict the outcome of this matter.
In the second quarter of 2016, the U.S. anti-obesity pharmaceutical market grew by 6% when compared to the first quarter of 2016, largely fueled by phentermine generics. During the same period, the U.S. branded anti-obesity segment including Qsymia remained flat.
On June 3, we launched our upgraded Qsymia patient savings offer to bring more new patients into the brand and support their weight loss effort for the long-term. In the new program, all new patients are eligible to receive $95 benefit at their first prescription of Qsymia. It may be used for 14 day free trial of the starting dose or $95 savings for 30 days’ supply of any dose. A subsequent monthly savings of $65 will continue for an extended savings benefit up to 36 months.
Our digital campaign is designed to direct inform consumers to productive Qsymia writers. Our enhanced web based strategies continue to deliver clear and compelling communications to potential patients, when they’re the most motivated to start a weight loss effort.
In the second quarter of 2016, the Qsymia site has seen 22% in repeat visitors versus the same period of 2015. Repeat visitors prove to be highly motivated to initiate Qsymia therapy as one in five download the Qsymia savings offer in preparation for starting their weight loss effort after visit to a physician.
On July 20, the United States District Court for the District of New Jersey issued a claim construction or Markman ruling governing patent litigation brought by VIVUS against Actavis and Teva. The lawsuits were filed in response to ANDAs filed by both Actavis and Teva. In these applications, Actavis and Teva seek to market and sell a generic version of the currently approved doses of Qsymia capsules, prior to the expiration of U.S. Patents listed in the FDA's Orange Book. There are 10 VIVUS patents asserted in the litigation, the last of which expires in 2029.
VIVUS filed the lawsuits on the basis that Actavis' and Teva's proposed generic products infringe the VIVUS patents. In the ruling, the Court’s adopted VIVUS' proposed constructions for all but one of the disputed claim terms and adopted a compromise construction that was acceptable to VIVUS for the final claim term. The next phase of the ongoing litigation with Actavis will be expert discovery. The Teva case remains in fact discovery. No trial date has been scheduled in either case.
As we’ve discussed in the past, we have post-marketing requirement for Qsymia to perform a cardiovascular outcomes trial or CVOT. To date, there have been no indications throughout the Qsymia clinical development program nor our post-marketing experience to have any increase in adverse cardiovascular event.
Given this historical information, along with the established safety profiles of phentermine and topiramate, we continue to believe that Qsymia poses no true cardiovascular safety risk. Representatives from VIVUS met with the FDA in May 2015 to discuss alternative strategies for obtaining CV outcomes data that would substantially more feasible and ensure timely collection of data to better inform on the CV safety of Qsymia.
As a part of addressing the FDA comments from this meeting, we are now working with cardiovascular and epidemiology experts in exploring alternate solutions to demonstrate the long-term cardiovascular safety of Qsymia. This current effort is focused on the conduct of a retrospective observational study to evaluate CV outcomes associated with Qsymia, phentermine and topiramate.
Although we and consulted experts believe there is no overt signal for CV risk to justify the CVOT, VIVUS is committed to working with FDA to reach a resolution. There is no assurance however that FDA will accept any measures, short of those specified in the CVOT to satisfy this requirement. As for the EU, even if FDA were to accept alternatives for traditional CVOT, there would be no assurance that EMAA would accept the same.
I will now turn the call back to Mark to discuss our financial results for the quarter ended June 30, 2016. I also refer you to the financial results and recent business updates included in our press release issued earlier today in our quarterly report on Form 10-Q filed earlier today.
Thank you, Seth. Total revenue was $13.8 million in the second quarter of 2016, compared to $23 million in the second quarter of 2015. Qsymia net product revenue was 12.7 million and 14.0 million for the second quarters of 2016 and 2015 respectively. These amounts represent approximately 116,000 and 152,000 prescriptions for the second quarters of 2016 and 2015 respectively, of which approximately 63.9% and 64% represent either a free or discounted offer respectively.
The net revenue per prescription excluding free trial offers was approximately $126 and $114 for the second quarters of 2016 and 2015 respectively. As a reminder, we recorded revenue for sales of Qsymia on a sell-through model, whereby revenue is recognized when a prescription is dispensed to a patient. As of June 30, 2016 our deferred revenue related to gross sales of Qsymia was $18 million, which represents product shipped to the wholesaler, but not yet dispensed to patient.
Avanafil supply revenue was nil and $8.1 million for the second quarters of 2016 and 2015 respectively. The variations in supply revenue are a result of the timing of orders placed by our partners that may or may not reflect end user demand for STENDRA and SPEDRA. Avanafil currently has a 48-month expiration date.
Royalty revenue earned on our partners’ net sales of Avanafil was approximately $1 million and $0.9 million in the second quarters of 2016 and 2015 respectively. As Seth mentioned previously U.S. and Canadian STENDRA commercial rates will return to us on September 1, 2016. As a result we will not receive royalty revenue from the U.S. for STENDRA moving forward without entering into a new licensing agreement.
Total cost of goods was $2.6 million and $9.9 million for the second quarters of 2016 and 2015 respectively. Gross margin percentages as a percentage of net Qsymia product revenue and net Avanafil supply revenue were 79.2% and 55.4% for the second quarters of 2016 and 2015. The change in gross margin percentages, were primarily due to the sales mix between Qsymia and Avanafil during the period.
Total research and development expense was 1.1 million and 2.6 million for the second quarters of 2016 and 2015 respectively. The variance was primarily due to the timing of clinical projects supportive of Qsymia post-marketing requirements.
During the second quarter of 2016, we focused our efforts on the development and feasibility assessments of our Qsymia retrospective cohort study. The Qsymia adolescent pharmacokinetic and pharmacodynamic study, and the protocol development of our Qsymia adolescent, efficacy and safety study.
Total selling and marketing expense was $6 million and $15.3 million for the second quarters of 2016 and 2015 respectively. The decrease in 2016 was due primarily to the realignment of our sales force, refinement of our marketing and promotional programs and cost control initiatives implemented in 2015.
General and administrative expenses were $7.7 million and $6.9 million for the second quarters of 2015 and 2016 respectively. The increase was primarily due to higher Qysmia litigation expense. Cash, cash equivalent and available for sale securities totaled $220.2 million at June 30t, 2016, as compared to $241.6 million at December 31, 2015. The decrease was primarily due to cashes in operating activities and debt service requirement.
I will now turn the call to Seth for closing comments.
Thank you, Mark. We at VIVUS remain confident on our two approved product. STENDRA’s 15 minute onset of action, high selectivity, resulting at lower side effects, ability to be taken with food and drink and STENDRA’s lower pricing uniquely addresses unmet needs for ED patients. We are equally prepared to commercialize STENDRA ourselves utilizing our existing infrastructure or licensing the right to a third party, whichever provides the greatest benefits to patients, healthcare providers and our stockholders.
Obesity continues to be a health care epidemic in the U.S. and around the world. Qsymia provides patients and their health care providers with a proven first line once a day therapeutic option. Obese patients using the standard dose of Qsymia along with diet and exercise, on average lose 10% of their body weight, 24pounds and four inches off their waist.
In the June 14, 2016 edition of JAMA, an article was published evaluating the efficacy and safety profiles of five currently marketed anti-obesity medications using a systematic review and meta-analysis. The study concluded that Qsymia was one of two therapies with the entire therapeutic class that was associated with the highest odds of achieving at least 5% weight loss. The publication again underscores Qsymia’s strong efficacy and safety profile.
The areas of focus for VIVUS for the second half of 2016 are to ensure a smooth transition of STENDRA from Endo, if we choose to self-commercialize, to integrate STENDRA into our current commercial infrastructure in an efficient and effective manner, maximize the value of the Avanafil commercialization rights for Canada, Latin America and India.
Manage our Avanafil alliances with Menarini and Sanofi to help ensure the commercial success of this important erectile dysfunction medication around the world, continues to compete effectively in the anti-obesity market by highlighting the benefits of Qsymia for this population. To advance our efforts to address in a cost effective manner, the remaining Qsymia regulatory post-marketing requirements evaluate potential in licensing opportunities to build our portfolio, products and product candidates and effectively manage our cost structure.
We are now happy to take your questions.
[Operator Instructions] And our first question comes from the line of Jessica Fye with JP Morgan. Your line is now open.
Hey guys, this is Ryan on for Jess. Appreciate you taking the question. I guess given that we are approaching that the transition date for STENDRA, can you talk a little bit more about - are you preparing the sales - are your sales force to train, to market the drug yourself or how do we think about sort of the timelines for self-commercialization versus waiting for securing a partnership?
We are moving down the path to commercialize the product that on our own, but also running down a parallel path as part of the strategic process to look at bringing on a potential out licensed partner and those are both actually running parallel. So we are in fact training our own people along with running the other process.
Okay. And can you give us any updates about the communication timelines for discussing with the FDA, sort of the design for the CVOT study?
So the discussions with FDA are actually ongoing. So they're not necessarily face to face, there's been correspondences going both ways between us and FDA over the last several months and we believe if there is something to further update the market on, we will definitely do that.
Okay. Thank you very much.
Thank you and I'm not showing any further questions at this time. I would now like to hand the call back to Mr. Seth Fischer, Chief Executive Officer for closing remarks.
Thank you operator and thank you all for calling in today, and we will look forward to updating you in the future.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone have a great day.
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