• by Les Luchter , August 8, 2023

America’s first over-the-counter birth control pill, Opill, will be supported later this year with pre-launch investments that will include building “large quantities of marketing and advertising plans,” Eduardo Bezerra, Perrigo’s chief financial officer, told analysts on a Q2 earnings call Tuesday morning.

Perrigo says that Opill, approved last month by the Food and Drug Administration, will hit retail shelves in early 2024.

“It’s a complex sell to consumers because of the nature of the category,” explained Patrick Lockwood-Taylor, who joined Perrigo as chief executive officer last month after running Bayer’s North American consumer health business for the past five years.

“We’re doing a lot of work on the awareness-to-trial conversion process, what consumer touchpoints are required, and how long that takes,” Lockwood-Taylor said in response to a question from JP Morgan analyst Chris Schott.

With those issues up in the air, Lockwood-Taylor said he couldn’t make any sales predictions at this point. As with any branded CPG product launch, he noted, Opill isn’t expected to contribute to corporate earnings for one or two years.

Lockwood-Taylor did say that Opill would “break down traditional barriers” for 64 million U.S. women, with “broad potential” for the uninsured, those “new to the category using less effective methods,” and those who “choose to switch from the prescription to the OTC product.”

Like Bayer, Perrigo is one of the increasingly rare number of companies in both the pharma and OTC spaces, and Taylor said that products switching to OTC from prescription “can be a very effective pathway to brand-building.” That’s largely due to strong retailer support, he said, mentioning news reports that “two leading drug chain stores have disclosed that they expect to offer Opill.”

A year ago, Perigo launched its first RX-to-OTC product with the allergy medication, Nasonex.

Opill is a direct result of Perrigo’s $1.9 billion 2022 acquisition of HRA Pharma and its prescription generic, norgestrel, which has now transformed into Opill.

In addition to such drugs as Nasonex and Opill, Perrigo -- which reported second quarter sales of $1.2 billion, up 6.4% year-over-year – is a leading player in private-label OTC store brands.

Lockwood-Taylor boasted that Perrigo has had more OTC ANDAs than other company. An ANDA is an FDA-approved Abbreviated New Drug Application, and Perrigo most recently used one to launch a store-brand equivalent to Pfizer’s AdvilDual Action Tablets “the day after the national brand’s exclusivity expired.”

“This innovation and speed-to-market enables our retail partners to truly differentiate their brands on the shelf,” he said.

Stating that “store brands are indeed branded self-care,” Lockwood-Taylor pointed out that “more consumers are choosing store brands as compared to national brands, evidenced by store brands’ volume share growth of 7 basis points over the last 13 weeks.”