A few, like Savella and Teflaro, will achieve more modest sales. But,
for example, Bystolic, launched several years ago, with sales of $108
million this last quarter, an increase of 20.1% over the previous year,
with its growth to be significantly augmented by the combination with
valsartan, presently in Phase III, is likely to be another one of our
largest products in coming years.
"The launch of every product requires major effort. It is costly financially and in human effort, and two in one quarter is especially demanding. Each involves sales force training and each involves a costly launch meeting with additional training and motivational presentations involving nearly two thousand sales and marketing personnel at each meeting. Most of those expenses were incurred in the last quarter for both products, including increased production costs for launch quantities, which were not compensated by initial stocking sales. Our marketing department and sales force membership and management exceeded even their usual impressive performance. It always takes a little while for the expense dust to clear, and to see the sales and profits generated by each new product.
"During the quarter we and our partner Gedeon Richter were pleased to announce that we have submitted the NDA to the FDA for cariprazine, a potent D3/D2 receptor partial agonist with preferred binding to D3 receptors, for the treatment of schizophrenia and Bipolar I Disorder. Schizophrenia and Bipolar I Disorder are serious medical conditions requiring treatment that affects millions of adult patients in the U.S. We are also studying cariprazine for the treatment of bipolar depression, and for treatment resistant depression. In addition, earlier this year we announced submission of our NDA for levomilnacipran for the treatment of major depressive disorder.
"In addition, we announced two important business development transactions during the quarter. In October we were pleased to announce that we entered into a broad strategic alliance with Moksha8 in Latin America. Moksha8 is a leader in the commercialization of CNS medicines in Latin America. Our alliance includes an exclusive license from Forest to Moksha8 to commercialize Viibryd, and potentially other Forest products and also provides us with an opportunity to acquire Moksha8 in two years under certain conditions. In November we were pleased to announce that we entered into an agreement with Adamas Pharmaceuticals for the development and commercialization of a fixed dose combination of Namenda XR and donepezil as a once-daily therapy for the treatment of moderate and severe dementia of the Alzheimer's type.
"The portfolio of our nine new products will cover six major therapeutic areas -- anti-infective, cardiovascular, central nervous system, gastrointestinal, respiratory and pain. Several of these products are already being developed in logical combination with other drugs, i.e. Bystolic and valsartan, Namenda XR and donepezil, Tudorza and formoterol, and Teflaro with avibactam. And there will be more to come as we continue to execute our business development strategy to find new product opportunities.
"We believe that we are well on our way to realizing the fruits of success from our new product portfolio that could ultimately generate significant levels of sales and earnings to more than replace the expiring products and secure long-term growth for our Company."
Use of Non-GAAP Financial Information
Non-GAAP earnings per share information adjusted to exclude certain costs, expenses and other specified items are summarized in the table below. This information is intended to enhance an investor's overall understanding of the Company's past financial performance and prospects for the future. This information is not intended to be considered in isolation or as a substitute for earnings per share prepared in accordance with GAAP.
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