With $112.5 million in hand from the sale of its wet, age-related macular degeneration (AMD) therapy Visudyne, QLT Inc. faced questions regarding payouts to shareholders and the fate of the company's oral retinoid program.
But, after accepting analysts' congratulations on the Visudyne (verteporfin) deal with Valeant Pharmaceuticals International Inc., QLT board chairman, Jason Aryeh, put off specific answers to those questions during a conference call.
"Right now, it's just premature," Aryeh said, noting that the board has "gone at a fairly blistering pace here, the first three and a half months [of mulling options], and frankly this deal went at such a pace as well." The board is slated to meet again today.
Vancouver, British Columbia-based QLT collected from Valeant, of Montreal, $112.5 million in cash. Of that amount, $62.5 million is for the Visudyne business in the U.S., and $50 million is for the right to royalties on Visudyne sales outside of the U.S., under a license agreement with Basel, Switzerland-based Novartis Pharma AG.
Under the terms, QLT also could get as much as $5 million in contingent payments relating to the development of its laser program in the U.S., plus up to $15 million relating to the Novartis non-U.S. royalties and a royalty on net sales of new indications for Visudyne, if any should be approved.
In July, QLT reduced staff from 214 to 68 and sent packing CEO Robert Butchofsky along with three other managers. (See BioWorld Today, July 10, 2012.)
Plans are in the works to divest the company's punctal-plug delivery system, too, since it's clearly a device and does not fit QLT's focus on therapeutics, Aryeh said. "I think there are others that can more efficiently and effectively maximize the value of that program," he said, though a buyer has not surfaced yet.
QLT091001, a synthetic oral retinoid that has reached Phase Ib studies, could prove worthy in Leber congenital amaurosis and retinitis pigmentosa. Aryeh said the board will evaluate that program's fate "in the most efficient manner possible."
He added that board has "tremendous respect for the asset and for the fact that [QLT091001] belongs to our shareholders. It's a program that our organization can absolutely run. We'll weigh it" like the board weighed Visudyne, he said. In March, trials against retinitis pigmentosa showed the drug gained rapid, statistically significant and clinically meaningful changes in visual fields from baseline values, as well as improvements in visual acuity
Although QLT is capable of advancing the retinoid, partnering is a possibility. "Everything strategic needs to be on the table every day," Aryeh said. "I would never dismiss something out of hand, if the right opportunity came up and the terms were right for our shareholders."
The FDA approved Visudyne in 2000, but the advent of VEGF inhibitor Macugen (pegaptanib sodium injection), cleared by the agency for AMD in 2005, meant a slide in market share. Valeant bought Macugen's owner, Eyetech Inc., of Palm Beach Gardens, Fla., in July for an undisclosed up-front payment and potential future milestones of less than two times sales.
After Macugen's approval came Basel, Switzerland-based Roche AG's VEGF inhibitor Lucentis (ranibizumab) and newcomer Eylea (aflibercept) from Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., both of which made QLT's competitive plight worse. (See BioWorld Today, Dec. 21, 2004, July 5, 2006, Jan. 18, 2008, and Nov. 22, 2011.)
Deciding how the shareholders will be rewarded best in the wake of the Visudyne deal is "a more complicated process, frankly, than I had hoped," Aryeh said. "There are reasons we have not acted to return capital yet. Our objective is not to sit on shareholders' money for the purpose of sitting on the shareholders' money."
The search for a new CEO was put on hold while QLT is revamped, Aryeh said.
"We needed to see as a board where we came out with this strategic process," Aryeh said. "It's clearly a very different company today than it was last week," and more decisions are yet to be made, he added, calling the result "a smaller company, a more acutely focused company and a developmental company with, fortunately, a tremendous balance sheet." When the smoke clears, the board will "reassess what that [CEO] position should look like," Aryeh said.
QLT's stock (NASAQ:QLTI) closed Monday at $8.14, up 50 cents. Valeant's shares (NYSE:VRX) ended the day at $54.98, down 13 cents.