NEWARK, Calif., April 2, 2015 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) today announced that it has closed the acquisition of the U.S. rights to the NUCYNTA franchise from Janssen Pharmaceuticals, Inc. for $1.05 billion. The NUCYNTA franchise includes: NUCYNTA® ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment; NUCYNTA®(tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults; and NUCYNTA (tapentadol) oral solution, an approved oral form of tapentadol that has not been launched. NUCYNTA is now the flagship asset in Depomed's growing portfolio of pain and neurology specialty pharmaceuticals. Full product labelling including Boxed Warnings for NUCYNTA ER and NUCYNTA is available at www.Nucynta.com.
- Depomed will begin shipping NUCYNTA the week of April 6, reflecting a price adjustment made after closing the deal
- Quintiles, the contract sales organization that promoted the NUCYNTA franchise for Janssen, will continue to support these products for Depomed from now until re-launch in June
- Depomed expects its expanded sales force supporting NUCYNTA, Gralise, Cambia and Zipsor to be fully deployed at re-launch
- Depomed will introduce new product positioning and marketing support focusing on the uniqueness of the molecule and its dual mechanism of action (MOA)
- The $575 million loan to complete financing of the transaction closed as expected, with no dilution to shareholders
- The company plans to update 2015 guidance inclusive of NUCYNTA sales as part of the first quarter financial report in May
"With the closing of the NUCYNTA transaction, the transformation of Depomed into a leader in the pain and central nervous system market is now complete. We closed the deal ahead of our original schedule and will re-launch NUCYNTA with Depomed's expanded sales and marketing resources in June," said Jim Schoeneck, President and Chief Executive Officer of Depomed. "The structure of the flexible loan agreement to complete the related financing avoided any dilution to our shareholders, provides an ability to prepay, and provides the opportunity to continue to pursue the acquisition of additional assets that fit within our strategy."
Depomed paid Janssen $1.05 billion in cash at closing. Depomed assumed the U.S. license and related royalty obligations for NUCYNTA to Grunenthal, the originator of tapentadol. At signing in January, Depomed placed $500 million into an escrow account which was released to Janssen upon closing of the transaction. In addition, Depomed used the net proceeds of the $575 million loan committed by Deerfield and Pharmakon Advisors in March 2015 to fund the balance of the purchase price.
New Product Positioning, Sales Coverage have Potential to Accelerate Growth
Depomed intends to re-launch NUCYNTA and NUCYNTA ER in June with an enhanced focus on the molecule's unique dual mechanism of action, and on NUCYNTA ER's approved indications based on studies in both nociceptive and neuropathic pain states. NUCYNTA ER is the only opioid FDA-approved for both chronic pain and neuropathic pain associated with diabetic peripheral neuropathy (DPN). NUCYNTA ER has not been fully launched for the DPN indication and Depomed believes the product's clinical benefits may not be fully appreciated in the US.
Depomed has also indicated that it expects NUCYNTA to benefit from synergies with the company's expanded commercial infrastructure. Depomed's current sales force overlaps approximately 70% of the NUCYNTA prescriber base, allowing the company to capitalize on well-established relationships with key prescribers. The expanded sales force for NUCYNTA of over 250 representatives, is over 3 times the size of the prior sales effort and will cover an even higher percentage of the prescribers.
NUCYNTA Performance, Impact of Acquisition
The NUCYNTA brands generated U.S. net sales of approximately $44 million in the fourth quarter of 2014 (unaudited) and $172 million for the year ended December 2014. NUCYNTA has composition of matter patent protection to August 2022, a potential pediatric extension into 2023 and additional patents beyond that timeframe.
Depomed expects the acquisition to be immediately accretive to non-GAAP EPS in 2015 and to provide significant growth in net sales, EBITDA, non-GAAP earnings and cash flow in future years. Return on invested capital is estimated to exceed cost of capital by 2016.
Morgan Stanley & Co. LLC acted as financial advisor to Depomed on the transaction. Baker Botts L.L.P. acted as legal advisor to Depomed.
Depomed is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. Our NUCYNTA® franchise includes NUCYNTA® ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, and NUCYNTA® (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise and various partner product candidates are formulated with Depomed's proven, proprietary Acuform® drug delivery technology. Additional information about Depomed may be found atwww.depomed.com.
Forward Looking Statements
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the Company's post-acquisition strategy, plans, objectives, expectations (financial or otherwise) and intentions relating to NUCYNTA, future financial results and growth potential and other statements that are not historical facts. Other risks are detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2014. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
August J. Moretti
Canale Communications for Depomed
SOURCE Depomed, Inc.