Marketing and Supply Agreement with Eisai/Ildong | Marketing and Supply Agreement with Eisai In November 2013, our wholly owned subsidiary, Arena Pharmaceuticals GmbH, or Arena GmbH, and Eisai Inc. and Eisai Co., Ltd. (collectively with Eisai Inc., Eisai) entered into the Second Amended and Restated Marketing and Supply Agreement, or Eisai Agreement. The Eisai Agreement expanded Eisai’s exclusive commercialization rights for lorcaserin to all of the countries in the world, except for South Korea, Taiwan, Australia, New Zealand and Israel. Lorcaserin is approved in the United States for chronic weight management in adults who are overweight with a comorbidity or obese, and was made available to patients by prescription in the United States by Eisai in June 2013. In addition to providing commercialization rights, which are subject to applicable regulatory approval, we manufacture and sell lorcaserin to Eisai and provide Eisai with services related to development and regulatory activities. Under the Eisai Agreement, we have received an upfront payment and payments from sales of lorcaserin, and are entitled to receive payments from future sales of lorcaserin, milestone payments based on the achievement of regulatory filings and approvals, one-time purchase price adjustment payments and other payments. Prior to entering into the Eisai Agreement, Arena GmbH and Eisai Inc. entered into the original marketing and supply agreement in July 2010, under which we granted Eisai Inc. exclusive commercialization rights for lorcaserin solely in the United States and its territories and possessions. In May 2012, Arena GmbH and Eisai Inc. amended and restated such agreement by entering into the first amended agreement, which expanded Eisai Inc.’s exclusive commercialization rights to include most of North and South America. The following table summarizes the revenues we recognized under our collaboration with Eisai for the periods presented, in thousands: Three months ended Nine months ended 2015 2014 2015 2014 Net product sales $ 3,274 $ 5,726 $ 11,603 $ 12,137 Amortization of upfront payments 1,886 1,885 5,656 5,745 Reimbursement of development expenses 107 143 1,454 7,456 Milestone payment 0 0 0 500 Reimbursement of patent and trademark expenses 72 105 304 333 Subtotal other Eisai collaborative revenue 2,065 2,133 7,414 14,034 Total $ 5,339 $ 7,859 $ 19,017 $ 26,171 The following table summarizes the deferred revenues under our collaboration with Eisai, in thousands: September 30, 2015 December 31, 2014 Upfront payments $ 88,818 $ 94,474 Net product sales 12,520 7,081 Total deferred revenues attributable to Eisai 101,338 101,555 Less current portion (20,061 ) (14,622 ) Deferred revenues attributable to Eisai, less current portion $ 81,277 $ 86,933 Upfront and Milestone Payments. In connection with entering into the Eisai Agreement, we received from Eisai an upfront payment of $60.0 million . This payment is in addition to the $50.0 million and $5.0 million in upfront payments we received from Eisai in connection with entering into the original agreement and the first amended agreement, respectively. Revenues from these upfront payments were deferred, as we determined that the exclusive rights did not have standalone value without our ongoing development and regulatory activities. Accordingly, these payments are recognized ratably as revenue over the periods in which we expect the services to be rendered, which are approximately 15 years for the Eisai Agreement and first amended agreement and 16 years for the original agreement. In addition to the upfront payments, we have received from Eisai a total of $86.5 million in milestones payments, and we are eligible to receive up to an aggregate of $176.0 million in additional regulatory and development milestone payments. Product Purchase Price and Purchase Price Adjustment Payments. We manufacture lorcaserin at our facility in Switzerland, and sell lorcaserin to Eisai for Eisai’s commercialization in the United States and, subject to applicable regulatory approval, in the other territories under the Eisai Agreement (other than Europe, China and Japan) for a purchase price starting at 31.5% and 30.75% , respectively (and starting at 27.5% in Europe, China and Japan), of Eisai’s aggregate annual net product sales (which are the gross invoiced sales less certain deductions described in the Eisai Agreement), or the Eisai Product Purchase Price, in the respective territory. The Eisai Product Purchase Price will increase on a tiered basis in the United States and the other territories (other than Europe, China and Japan) to as high as 36.5% and 35.75% , respectively, on the portion of Eisai’s annual aggregate net product sales exceeding $750.0 million in all territories other than Europe, China and Japan. The Eisai Product Purchase Price will increase to 35% in Europe, China and Japan on the portion of Eisai’s annual aggregate net product sales exceeding $500.0 million in such territories. The Eisai Product Purchase Price is subject to reduction (for sales in a particular country), including in the event of generic competition in the applicable country. The revenue we recognize for BELVIQ product revenue related to the use of vouchers and product samples is based on our cost of goods sold. In addition to payments for purchases of lorcaserin, we are eligible to receive up to an aggregate of $1.56 billion in one-time purchase price adjustment payments and other payments. These payments include up to an aggregate of $1.19 billion that are based on Eisai’s annual net product sales of lorcaserin in all of the territories under the Eisai Agreement on an aggregate basis, with the first and last amounts payable with annual net product sales of $250.0 million and $2.5 billion , respectively. Of these payments, Eisai will pay us a total of $330.0 million for annual net product sales of up to $1.0 billion . The $1.56 billion also includes $370.0 million in one-time purchase price adjustment payments we are eligible to receive based on annual net product sales in the non-US territories, comprised of $185.0 million based on Eisai’s annual net product sales in the non-US territories in North and South America and $185.0 million based on Eisai’s annual net product sales in the territories outside of North and South America. The first and last amounts are payable upon first achievement of annual net product sales of $100.0 million and $1.0 billion , respectively, with respect to each of the following areas: (i) the non-US territories in North and South America and (ii) the territories outside of North and South America. In addition, we are also eligible to receive certain payments by Eisai if certain annual minimum sales requirements in Mexico, Canada and Brazil are not met during the first ten years after initial commercial sale in such territories. The amount that Eisai pays us for lorcaserin product supply is based on Eisai’s estimated price at the time the order is shipped, which is Eisai’s estimate of the Eisai Product Purchase Price, and is subject to change on April 1 and October 1 of each year. At the end of Eisai’s fiscal year (March 31), the estimated price paid to us for product that Eisai sold to their distributors is compared to the Eisai Product Purchase Price of such product, and the difference is either refunded back to Eisai (for overpayments) or paid to us (for underpayments). On a monthly basis, Eisai provides us the total amount of net product sales for the month, details of the total deductions from gross to net product sales and the sales in units. We recognize our revenues monthly based on our percentage of Eisai’s monthly net product sales figures. When the revenues we recognize differ from the estimated price that Eisai paid us for such product, the difference is reclassified from deferred revenues to a receivable or payable account, as appropriate. We also adjust the deferred revenues balance for the product supply held at Eisai based on the most current net product sales figures provided to us, with the difference reclassified from deferred revenues to a receivable or payable account. The Eisai Product Purchase Price for the product Eisai has sold to date has been lower than the initial estimated price that Eisai has paid us for such product, primarily due to an increase in deductions from savings cards and returns, partially offset by a decrease in vouchers. In January 2015, Eisai announced the launch of a new savings card which enables eligible patients without commercial coverage for BELVIQ to pay no more than $75 for each monthly prescription while those patients with commercial coverage for BELVIQ are able to use the card to obtain additional savings if their copay is greater than $50 per monthly prescription. Subsequent to the end of Eisai’s fiscal year, we refund the portion of these excess payments, which total the $10.6 million classified as Payable to Eisai on our condensed consolidated balance sheet at September 30, 2015 , related to product sold by Eisai to their distributors through March 31. Development Payments. In connection with the US approval of BELVIQ, the US Food and Drug Administration, or FDA, is requiring (i) an evaluation as part of the cardiovascular outcomes trial, or CVOT, of the effect of long-term treatment with BELVIQ on the incidence of major adverse cardiovascular events, or MACE, in overweight and obese patients with cardiovascular disease or multiple cardiovascular risk factors and (ii) the conduct of postmarketing studies to assess the safety and efficacy of BELVIQ for weight management in obese pediatric and adolescent patients. In addition to the FDA-required studies, we and Eisai have prioritized the development and approval of a once-daily formulation of lorcaserin, as well as potentially exploring, including as part of the CVOT, BELVIQ’s effect on conversion to type 2 diabetes and improvements in cardiovascular outcomes. The chart below summarizes the general agreement regarding cost sharing between Eisai and us for significant development activities under the Eisai Agreement. In addition, Eisai or we may from time to time conduct approved development of lorcaserin at such party’s own expense. Eisai Second Amended and Restated Marketing and Supply Agreement: Cost Sharing for Development United States Rest of North and South America Remaining Territories BELVIQ - Pre-approval* Not Applicable General Eisai: 90%; Arena: 10% Certain stability work Eisai: 50%; Arena: 50% Up to a total of $100.0 million - Eisai: 50%; Arena: 50% Thereafter, Eisai: 100% BELVIQ - Post-approval* General Eisai: 90%; Arena 10% Non-FDA required portion of CVOT Up to $80.0 million - Eisai: 50%; Arena: 50% Thereafter, Eisai: 100% Certain pediatric studies Eisai: 50%; Arena: 50% General Eisai: 90%; Arena: 10% Certain stability work Eisai: 50%; Arena: 50% Up to a total of $50.0 million - Eisai: 50%; Arena: 50% Thereafter, Eisai: 90%; Arena: 10% Lorcaserin products other than BELVIQ - Pre-approval Up to a total of $250.0 million (as reduced by up to $80.0 million for non-FDA required portion of CVOT) -Eisai: 50%; Arena: 50% Lorcaserin products other than BELVIQ - Post-approval Up to a total of $100.0 million in the aggregate across all additional products - Eisai: 50%; Arena: 50% Thereafter, Eisai: 90%; Arena: 10% ______________________ * Development required by a regulatory authority, with the exception of the non-FDA required portions of the CVOT. Certain Other Terms. Please refer to our Annual Report on Form 10-K for the year ended December 31, 2014 , for additional information regarding termination, indemnification, product liability, certain limitations and other provisions included in the Eisai Agreement. |