Stung by a court decision late last year that invalidated its patents for its second best-selling drug, Allergan said it will eliminate 1400 jobs—1000 now-filled and 400 open positions—in a restructuring designed to cut costs.
Employees to be laid off, Allergan said in a regulatory filing yesterday, are in commercial positions that “primarily focus on products and categories subject to loss of exclusivity”—a category that includes Allergan’s number-two drug, the dry-eye treatment Restasis® (cyclosporine ophthalmic emulsion).
Allergan said it expects to incur approximately $125 million in costs related to its restructuring, primarily due to severance, with most of the expense to be recorded with the company’s fourth-quarter 2017 results. That expense does not include charges related to potential building closures, contract terminations, and unspecified other items.
“Overall operating expense savings from this internal restructuring are expected to be in the range of $300 to $400 million as compared to the fiscal year 2017,” Allergan stated in a Form 8-K filing.
The filing came three months after the U.S. District Court for the Eastern District of Texas invalidated four key Allergan patents for Restasis, ruling that they covered intellectual property that was unpatentable because it was obvious.
Allergan is appealing the decision, which included criticism by U.S. Circuit Judge William C. Bryson of the company for a September 2017 deal through which it sought to protect the patents—namely paying the Saint Regis Mohawk Tribe to take ownership of the patents, then leasing them back from the Native American tribe.
“Sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities,” Judge Bryson wrote in a 135-page opinion filed October 16.
Allergan responded in part by taking against third-quarter 2017 earnings a
Warning of Cost Cuts
And in discussing Q3 results November 1 on the company’s quarterly conference call, Allergan chairman, president, and CEO Brenton L. (Brent) Saunders warned analysts that the company would respond to its loss-of-exclusivity challenges by swinging the proverbial axe.
“Those challenges are manageable, and we will deal with them head-on. We know how to take costs out of our company while maintaining the right level of investment to drive future growth. We've done this before,” Saunders said, according to published transcripts.
“This business will generate significant cash flow even if we were to lose Restasis, and we will deploy that cash flow to create value for our shareholders,” Saunders added.
Restasis generated $1.059 billion in net revenues during the first three quarters of 2017, up 3.2% from $1.026 billion in Q1–Q3 2016. For all of 2016, Restasis racked up $1.488 billion in net revenues, accounting for about 10% of Allergan’s total revenues. The dry-eye treatment is Allergan’s top-selling drug after Botox®.
Restasis is a calcineurin inhibitor immunosuppressant that is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
Back in November, Saunders also said Allergan faces potential generic competition for some of its other treatments—including Estrace® cream (estradiol vaginal cream, USP, 0.01%) for vaginal dryness, itching, and burning in or around the vagina due to menopause; Namenda XR® (memantine HCI) once-a-day extended release capsules for moderate to severe Alzheimer's disease); Delzicol® (mesalamine) for mildly to moderately active ulcerative colitis; and acne treatment Aczone® (dapsone).