DUBLIN and WESTLAKE VILLAGE, Calif., June 17, 2015 — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH), a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market, today announced that they 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 U.S. 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 U.S. 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 percent of consumers are bothered by submental fullness.i
KYTHERA is executing a training-led launch in the U.S. 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 U.S. began in June 2015. KYBELLA™ physician training programs will initiate in late summer. Qualified injectors in the U.S. 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.
J.P. 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.
About KYBELLA™
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.
Important Safety Information
KYBELLA should only be administered by a trained healthcare professional.
KYBELLA is contraindicated in the presence of infection at the injection sites.
Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage.
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported during clinical trials. To avoid the potential for nerve injury, KYBELLA should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days).
Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of KYBELLA in these patients as current or prior history of dysphagia may exacerbate the condition.
In clinical trials, 72% of subjects treated with KYBELLA experienced injection site hematoma/bruising. KYBELLA should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.
To avoid the potential of tissue damage, KYBELLA should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles.
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan’s website at www.allergan.com.
About KYTHERA®
KYTHERA Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. In addition to its lead product KYBELLA™, KYTHERA also licensed the worldwide rights to setipiprant (KYTH-105), an early-stage potential treatment for hair loss. KYTHERA’s longer-term strategy is to leverage its biotechnology and aesthetics experience to expand its product portfolio and pipeline. KYTHERA has submitted regulatory filings for ATX-101 in Canada, Switzerland and Australia. Find more information at www.kythera.com.
Leave a Reply
You must be logged in to post a comment.