Allergan plc, a leading global pharmaceutical company, and biopharmaceutical company, Kythera Biopharmaceuticals, Inc. have entered into a definitive agreement under which Allergan has agreed to acquire Kythera in a cash and equity transaction valued at $75 per Kythera share, or approximately $2.1 billion, subject to the fulfillment of certain customary conditions summarized below. The fixed-value transaction consideration will be payable 80 percent in cash and 20 percent in new AGN shares issued to Kythera shareholders.
Allergan's 2015 earnings-per-share forecast provided on May 11, 2015 is unchanged as a result of the acquisition. The acquisition is expected to be breakeven in 2016 and accretive thereafter. The Company remains committed to de-levering to below 3.5x debt to Adjusted EBITDA by the end of the first quarter of 2016.
The acquisition of Kythera immediately enhances Allergan's global facial aesthetics portfolio with the addition of Kybella (deoxycholic acid) injection, the first and only approved non-surgical treatment for contouring moderate to severe submental fullness, commonly referred to as double chin. Kybella was approved by the US Food and Drug Administration (FDA) on April 29, 2015. Kybella injection is also being developed for potential introduction into international markets; Kythera has submitted Kybella injection for regulatory approval in Switzerland, Canada and Australia, with other market applications to follow. The acquisition will also add Kythera's development product setipiprant (KYTH-105), a novel compound for the prevention of male pattern baldness, as well as additional early-stage development candidates.
"The acquisition of Kythera is a strategic investment that strengthens our leading global position in aesthetics and continues to position us for long-term growth," said Brent Saunders, CEO and president of Allergan. "Kybella is an exciting new product that offers patients the first and only clinically-proven, non-surgical treatment for submental fullness (excess fat under the chin). As a leader in aesthetics, we know our customers are looking to offer their patients new options beyond traditional facial aesthetics. Kybella will do that while complementing our market leading facial aesthetics portfolio, which includes Botox, Juvederm XC, Juvederm Voluma XC, Latisse and Skinmedica. Kybella is also a pivotal entry point for expanding the use of facial aesthetic products in men, while Kythera's setipiprant (hair-loss) development program can drive additional long-term value."
"Allergan's world-class medical aesthetics, global footprint, history and commitment to developing leading aesthetic products makes them ideally suited to realize the maximum commercial potential of Kybella," said Keith Leonard, CEO and President of Kythera. "I am deeply appreciative of the commitment and dedication of our Kythera team that worked so tirelessly to bring Kybella from early development through approval and launch. We look forward to working with Allergan to ensure a successful US launch of Kybella, as well as to secure additional approvals globally."
Submental fullness is a common yet undertreated condition that can detract from an otherwise balanced and harmonious facial appearance - leading to an older and heavier look. Submental fullness can affect adults - both women and men - of all ages, weight and gender. Influenced by multiple factors including aging and genetics, submental fullness is often resistant to diet and exercise. According to a 2015 survey by the American Society for Dermatologic Surgery, 67 per cent of consumers are bothered by submental fullness.
Kythera is executing a training-led launch in the US supported by a training program designed to educate physicians and qualified injectors on the safe use of Kybella and its approved indication. Physician faculty education in the US began in June 2015. Kybella physician training programs will initiate in late summer. Qualified injectors in the US will be able to purchase Kybella and treat their patients after they have been trained.
Allergan's acquisition of Kythera is subject to approval by the shareholders of Kythera, expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and fulfillment of certain other customary conditions to closing. Pending such approvals and fulfillment of other conditions, Allergan currently anticipates closing the transaction in the third quarter of 2015.
JP Morgan is serving as financial advisor to Allergan and Covington & Burling LLP is serving as Allergan's lead legal counsel. Goldman Sachs is serving as financial advisor to Kythera and Latham & Watkins LLP is serving as Kythera's lead legal counsel.
Kybella is the first and only approved non-surgical treatment for contouring moderate to severe submental fullness, commonly referred to as double chin. Kybella is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat. When injected into subcutaneous fat, Kybella causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.
Kybella (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
The safe and effective use of Kybella for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
Kythera Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market.