The Deal: Vivus Considers Next Steps With Big Pharma Partners

NEW YORK ( The Deal) -- Tony Zook is facing major headwinds in his effort to steer the fortunes of Vivus ( VVUS), and crucial to that effort is bringing the right licensing partner on board to help commercialize its weight-loss drug Qsymia.

"A large pharmaceutical partner is critical to realize the full potential of the Qsymia franchise and to build the market. To date we've made good progress in this area," Zook, Vivus' new CEO, said during the company's second quarter sales and earnings conference call with investors held late Tuesday, Aug. 7.

Vivus developed the promising weight-loss drug Qsymia, and received approval for it a little more than a year ago by the Food and Drug Administration. But it had a disappointing launch and this was borne out in its second-quarter financials. While Qsymia prescriptions were up 37% quarter over quarter, they translated into a mere $5.5 million in sales, and Vivus spent $52.5 million during the quarter. All those scripts were filled via its four certified mail-order pharmacies, a burdensome FDA requirement that has since been lifted.

Vivus recently suffered through a mutiny of sorts, a difficult proxy fight that was finally settled in favor of its 9.9% investor First Manhattan Corp. FMC insisted on the ouster of top management and the creation of a new 11-member board including CEO Tony Zook, a former AstraZeneca executive who has successfully commercialized several drugs. The new board was carefully selected, FMC said, to help provide the necessary expertise for the turnaround. Only one of the four non-FMC-chosen board members, Mark Logan, was appointed prior to April, when FMC began its activist campaign.

However, as the proxy fight was raging, Vivus started to make strides in its Qsymia launch. The company has signed up more than 10,000 certified retail pharmacies, including national and retail chains such as Walgreen ( WAG) and Duane Reade. Independent pharmacies will come on board in the fourth quarter, the company said. Along with expanding access to retail outlets, the company has been working with insurers to bring co-pays down to a more consumer-friendly $25 to $35, from the earlier $50 to $65 range.

The reduced co-pays and increased access should make the franchise more palatable to a big pharma partner. Plus, Vivus has increased its prescribing physicians by 39% to about 21,000, with endocrinologists making up the most active prescribers.

Critical to Qsymia's momentum now is primary care practitioners who will prescribe the drug, which is what a partner could bring to the table. The company is continuing its discussions to select a large pharmaceutical company that will offer it the best option for increasing Qsymia commercialization efforts with primary care physicians, according to CFO Tim Morris. "We believe this is critical to maximizing the value of the brand and growing the obesity market."

"I believe potential partners will be impressed with the retail pharmacy uptake," Zook said. "The board and I are personally involved in this process and we're committed to completing these discussions as rapidly as possible," he added.

"Dealing with Vivus' operational issues will be no easy task," according to Cowen and Co. biotechnology analyst Simos Simeonidis. "But we have significantly more confidence in this new board and CEO's ability to: 1) fix the launch, 2) cut expenses, and 3) deliver a pharma partnership," Simeonidis wrote in an Aug. 7 research note. "Despite its disappointing launch we continue to view Qsymia as a very efficacious weight loss agent and expect an eventual pickup in Qsymia scripts in 2H13," he said.

-- Written by Pamela Taulbee in New York

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