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Neurocrine Biosciences Inc. Reports Operating Results (10-K)

February 09, 2012 | About:
NurseB911

10qk

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Neurocrine Biosciences Inc. (NBIX) filed Annual Report for the period ended 2011-12-31.

Neurocrine Biosciences Inc. has a market cap of $517.7 million; its shares were traded at around $9.37 with a P/E ratio of 13.6 and P/S ratio of 15.5.

Highlight of Business Operations:

Under the terms of the agreement, Abbott is responsible for all development, marketing and commercialization costs. We will receive funding for certain internal collaboration expenses which includes reimbursement from Abbott for internal and external expenses related to the GnRH Compounds, which reimbursement includes up to approximately $24 million in personnel funding through the end of 2012. We will be entitled to a percentage of worldwide sales of GnRH Compounds for the longer of ten years or the life of the related patent rights. Under the terms of our agreement with Abbott, the collaboration effort between the parties to advance the GnRH compounds toward commercialization is governed by a joint development committee with representatives from both Neurocrine and Abbott; provided, however, that final decision making authority rests with Abbott. Abbott may terminate the collaboration at its discretion upon 180 days written notice to us. In such event, we would be entitled to specified payments for ongoing clinical development and related activities and all GnRH Compound product rights would revert to us. Our participation in the joint development committee has been determined to be a substantive deliverable under the contract, and therefore, the upfront payment has been deferred and is being recognized over the estimated term of the joint development committee, which is expected to be through the end of 2012. For the years ended December 31, 2011 and 2010, we recorded revenues of $29.0 million and $16.9 million in amortization of up-front license fees, respectively, and $9.1 million and $10.1 million in sponsored development revenue, respectively, under the Abbott collaboration agreement. Additionally, during 2011 we recorded $30.0 million in milestone revenue, $10.0 million of which was related to advancing elagolix into Phase II clinical trials for uterine fibroids and $20.0 million of which was related to the outcome of an elagolix pre-Phase III meeting with the FDA for endometriosis. At December 31, 2011, we had $29.0 million of deferred revenue related to the Abbott agreement, which is being amortized over the estimated remaining collaborative development period.

approximately $3 million in additional preclinical milestone payments and $223 million in clinical development and commercial event based payments. We have assessed milestones under the revised authoritative guidance for research and development milestones and determined that the preclinical milestone payments, as defined in the agreement, meet the definition of a milestone as they are 1) events that can only be achieved in part on our past performance or upon the occurrence of a specific outcome resulting from our performance, 2) there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and 3) they result in additional payments being due to us. Clinical development and commercial milestone payments, however, currently do not meet this criteria as their achievement is solely based on the performance of Boehringer Ingelheim. No milestone payments have been recognized to date. We will be entitled to a percentage of any future worldwide sales of GPR119 agonists resulting from the collaboration. Under the terms of the agreement, the collaboration effort between the parties to identify and advance GPR119 agonist candidates into preclinical development is governed by a steering committee with representatives from both Neurocrine and Boehringer Ingelheim; provided, however, that the final decision making authority rests with Boehringer Ingelheim. Boehringer Ingelheim may terminate the agreement at its discretion upon prior written notice to us. In such event, we may be entitled to specified payments and product rights would revert to us. Our participation in the steering committee has been determined to be a substantive deliverable under the contract, and therefore, the upfront payment has been deferred and is being recognized over the estimated term of the steering committee, which is expected to be through June 2012. For the years ended December 31, 2011 and 2010, we recorded revenues of $5.0 million and $2.7 million in amortization of up-front license fees and $1.3 million and $0.8 million in sponsored research related to the Boehringer Ingelheim agreement, respectively. At December 31, 2011, we had $2.3 million of deferred license fees that will be amortized over the estimated remaining collaborative research period of the agreement.

(including elagolix) and GPR119 programs, respectively. During 2010, we recognized revenue of $19.6 million from amortization of up-front license fees and $10.9 million resulting from sponsored research and development reimbursement under these two collaboration agreements.

Net cash used in investing activities during 2011 was $3.5 million compared to $54.7 million and net cash provided of $12.1 million in 2010 and 2009, respectively. The fluctuation in net cash provided by (used in) investing activities resulted primarily from the timing differences in investment purchases, sales and maturities, and the fluctuation of our portfolio mix between cash equivalents and short-term investment holdings. The average term to maturity in our investment portfolio is less than one year.

We believe that our existing capital resources, together with investment income and future payments due under our strategic alliances, will be sufficient to satisfy our current and projected funding requirements for at least the next 12 months. However, we cannot guarantee that our existing capital resources and anticipated revenues will be sufficient to conduct and complete all of our research and development programs as planned.

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