Summary of Significant Accounting Policies (Polices) | 12 Months Ended |
Dec. 31, 2014 |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation |
The Company’s financial statements as of December 31, 2014, and 2013 and for the years then‑ended have been prepared in accordance with accounting principles generally accepted in the United States. |
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Reverse Stock Split and Conversion of Preferred Stock | Reverse Stock Split and Conversion of Preferred Stock |
On November 1, 2013, our board of directors and the requisite holders of our voting stock authorized the filing of a certificate of amendment to our amended and restated certificate of incorporation for the purposes of effecting a 3.1‑for‑1 reverse split of the common stock. The certificate of amendment was filed on November 1, 2013 and the stock split became effective as of that date. Accordingly, all references to numbers of common shares, including the number of common shares on an as‑if‑converted basis, per‑share data and share prices and exercise prices in the accompanying financial statements have been adjusted to reflect the reverse stock split on a retroactive basis. |
Each 3.1 shares of convertible preferred stock was convertible, at the stockholder’s option, into one share of common stock. Additionally, each share of convertible preferred stock was automatically converted into common stock, at the then‑effective conversion rate upon the effective date of a registration statement filed with the SEC under the Securities Act or Exchange act. |
On December 3, 2013, our registration statement on Form S‑1 related to our initial public offering became effective and 49,671,392 shares of Series A‑1 preferred stock converted into 16,022,915 shares of common stock and 1,851,814 shares of Series A‑2 preferred stock converted into 597,359 shares of common stock. |
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Use of Estimates | Use of Estimates |
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. |
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Recent Accounting Pronouncements | Recent Accounting Pronouncements |
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In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers, which establishes principles for reporting revenue and cash flows arising from an entity’s contracts with customers. The new pronouncement is effective for reporting periods beginning after December 15, 2016 and will replace most of the existing revenue recognition guidance within the United States GAAP. The new pronouncement permits the use of either the retroactive or cumulative effect transition method. Early adoption is not permitted. |
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The Company is evaluating the effect that ASU 2014-09 will have on its financial statements and related disclosures. |
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Revenue Recognition | Revenue Recognition |
We have, to date, earned revenue from research collaborations, which may include research and development services, licenses of our internally‑developed technologies, or a combination of both. We recognize revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; transfer or access of technology has been completed or services have been rendered; our price to the customer is fixed or determinable and collectability is reasonably assured. |
The terms of our license and research and development agreements generally include nonrefundable upfront payments, research funding, license fees and, milestone and other contingent payments to us for the achievement of defined collaboration objectives and certain clinical, regulatory and sales‑based events, as well as royalties on sales of any commercialized products. |
The terms of our licensing agreements include non‑refundable upfront fees, annual licensing fees, and contractual payment obligations for the achievement of pre‑defined preclinical, clinical, regulatory and sales‑based events by our partners. The licensing agreements also include royalties on sales of any commercialized products by our partners. |
Multiple‑Element Revenue Arrangements. Certain of our collaboration and license agreements represent multiple‑element revenue arrangements. To account for such transactions, we determine the elements, or deliverables, included in the arrangement and determine which deliverables are separate units for accounting purposes. We consider delivered items to be separate units of accounting if the delivered items have stand‑alone value to the customer. If the delivered items are separate units we allocate the consideration received or due under the arrangement to the various elements based on each elements’ relative selling price. The identification of individual elements in a multiple‑element arrangement and the estimation of the selling price of each element involve significant judgment, including consideration as to whether each delivered element has standalone value to the customer. We determine the estimated selling price for deliverables within each arrangement using vendor‑specific objective evidence (VSOE) of selling price, if available, or third‑party evidence of selling price if VSOE is not available, or our best evidence of selling price if neither VSOE nor third‑party evidence is available. |
Determining the best estimate of selling price for a deliverable requires significant judgment. We use our best estimate of selling price to estimate the selling price for licenses to our technologies and product candidates, since we do not have VSOE or third‑party evidence of selling for these deliverables. The basis of our estimate of selling price is the arm’s length negotiation with the licensee that occurs in each transaction. The potential value of our technology to a licensee in a transaction depends on a variety of factors unique to each transaction. Factors that impact the negotiation and hence that we consider in our estimates center on the specific product candidate and include: the product candidate’s potential market size, the product candidate’s stage of development, the existence of competitive technologies that could be substituted for ours by the licensee and the scientific assessment of the product candidate’s likelihood of success at various development stages. The most common deliverable is the commercial license for our technology in the product candidate, and frequently a research license with an option for commercial license. The upfront payments, annual license fees, contingent payments, milestones and royalties relate to these licenses and/or options and depend on the product‑specific factors described above. The other significant deliverable is research and development services and the price for these depends on estimates for our personnel and supply costs and the costs of third‑party contract research organizations necessary to support the services. |
We recognize consideration allocated to an individual element when all other revenue recognition criteria are met for that element. Our multiple‑element revenue arrangements may include the following: |
| · | | License arrangements. The deliverables under our collaboration and license agreements generally include exclusive or non‑exclusive licenses to one or more of our technologies. The technologies can be applied to a collaborator’s product candidates for discovery, development, manufacturing and commercialization. We will also enter into agreements for the exclusive or non‑exclusive licenses to our internally developed product candidates. To account for this element of the arrangement, we evaluate whether the exclusive or non‑exclusive license has standalone value apart from the undelivered elements to the collaboration partner, which may include research and development services or options for commercial licenses, based on the consideration of the facts and circumstances of each arrangement, including the research and development capabilities of the collaboration partner and other market participants. We recognize arrangement consideration allocated to licenses upon delivery of the license, if the facts and circumstances indicate the license has standalone value apart from the undelivered elements. If facts and circumstances indicate that the delivered license does not have standalone value from the undelivered elements, we recognize the revenue as a combined unit of accounting. In those circumstances we recognize revenue from non‑refundable upfront fees in the same manner as the undelivered item(s), which is generally the period over which we provide research and developments services. | | | | | | | | | | |
| · | | Research and Development Services. The deliverables under our collaboration and license arrangements may include research and development services we perform on behalf of or with the collaboration partner. As the provision of research and development services is an integral part of our operations and we may be principally responsible for the performance of these services under the agreements, we recognize revenue on a gross basis for research and development services as we perform those services. Additionally, we recognize research related funding under collaboration research and development efforts as revenue as we perform or deliver the related services in accordance with contract terms. | | | | | | | | | | |
Milestone Revenue. Our collaboration and license agreements generally include contingent contractual payments related to achievement of specific research, development and regulatory milestones and sales‑based milestones that are based solely upon the performance of the licensor or collaborator. Research, development and regulatory contingent contractual payments and milestone payments are typically payable under our collaborations when our collaborator selects a compound, or initiates or advances a covered product candidate in preclinical or clinical development, upon submission for marketing approval of a covered product with regulatory authorities, upon receipt of actual marketing approvals of a covered product or for additional indications, or upon the first commercial sale of a covered product. Sales‑based contingent contractual payments are typically payable when annual sales of a covered product reach specific levels. |
At the inception of each arrangement that includes contingent contractual payments, we evaluate whether each potential payment and milestone is substantive and at risk to both parties based on the basis of the contingent nature of the milestone event. We evaluate factors such as scientific, regulatory, commercial and other risks that we must overcome to achieve the respective milestone event, whether the contractual payments due at each milestone event is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment and whether the contingent contractual payment relates solely to past performance. Additionally, certain of our product development and technology license arrangements may include milestone payments related to the achievement of specific research and development milestones, which are achieved in whole or in part on our performance. |
We recognize any payment that is contingent upon the achievement of a substantive milestone entirely in the period in which the milestone is achieved. A milestone is defined as an event that can only be achieved based in whole or in part either on our performance, or the performance of our collaborators, or the occurrence of a specific outcome resulting from our past performance for which there is a substantive uncertainty at the date the arrangement is entered into that the event will be achieved. |
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Collaborative Research and Licensing Agreements | Collaborative Research and Licensing Agreements |
Novo Nordisk A/S |
In December 2014, we entered into a Collaboration and License Agreement with Novo Nordisk A/S (Novo). Under the terms of the agreement, we granted Novo a research license to use certain Xencor technologies including our bispecific, IIb, Xtend and others during a two year research term. We will provide research support for four FTE’s in collaboration with Novo to apply our technologies to Novo provided targets to identify compounds with improved properties. Novo has an option to extend the research term for another twelve months upon written notice to us and payment of another year of research funding. At the end of the research term, Novo will have a commercial license to develop and commercialize any new targets identified during the research term. |
Under the agreement, in January 2015, we received an upfront payment of $2.5 million and we will receive research funding of $1.6 million per year over the research term. We are also eligible to receive $2.0 million in milestone payments upon the successful completion of certain projects during the research term. In addition, if Novo identifies a compound from the collaboration to advance into clinical development, we are eligible to receive future development, regulatory and commercial milestone payments and royalties. The potential future milestones total $167.3 million and include $36.3 million in development milestones, $51.0 million in regulatory milestones and $80.0 million in sales milestones. |
We determined that the deliverables under the arrangement were the research license to our technologies and the research support. We believe that the research support and the technologies are integral to each other and are not separate units of accounting. The commercial license did not have standalone value at inception of the arrangement due to the uncertainty of identifying a commercial target. |
At inception of the arrangement, we determined that consideration under the agreement is represented by the upfront payment and the research funding and we are recognizing the $2.5 million upfront payment as income over the two year research term. The research funding is being recognized into income over the period that the services are being provided. We determined that future milestone payments were substantive and contingent and we did not allocate any of the upfront consideration to these milestones. |
During the year ended December 31, 2014 we recognized $0.1 million in revenue related to the arrangement; as of December 31, 2014 we have $2.9 million in deferred revenue related to the agreement. |
MorphoSys Ag |
In June 2010, we entered into a Collaboration and License Agreement with MorpohSys AG (MorphoSys), which we subsequently amended in March 2012. The agreement provided us an upfront payment of $13.0 million in exchange for an exclusive worldwide license to our patents and know‑how to research, develop and commercialize our XmAb5574 product candidate (subsequently renamed MOR208) with the right to sublicense under certain conditions. Under the agreement, we agreed to collaborate with MorphoSys to develop and commercialize XmAb5574/MOR208. We determined that the arrangement was one with multiple deliverables and we identified the multiple elements in the agreement as the license of XmAb5574/MOR208 and the research and development services provided by us for the initial Phase 1 clinical trial. If certain developmental, regulatory and sales milestones are achieved, we are eligible to receive future milestone payments and royalties. We determined that the future milestone payments were substantive and contingent and we did not allocate any of the upfront consideration to these milestones. Our responsibility with respect to the collaboration services is limited to completion of the Phase 1 clinical trial. MorphoSys is responsible all further development of XmAb5574/MOR208. |
Under the terms of the amendment, we received additional proceeds for the additional research and development services related to extension of the Phase 1 clinical trial. During 2012, we recognized $0.4 million of revenue related to the additional services provided. |
In April and May 2013, MorphoSys initiated two Phase II clinical trials under the arrangement and we received a milestone payment of $3.0 million. We have recognized the payment as revenue in the period that the milestone event occurred. |
The total revenue recognized under this arrangement was zero, $3.0 million and $2.0 million for the years ended December 31, 2014, 2013 and 2012, respectively. As of December 31, 2014, we have no deferred revenue related to this agreement. |
Alexion Pharmaceuticals, Inc. |
In January 2013, we entered into an option and license agreement with Alexion Pharmaceuticals, Inc. (Alexion). Under the terms of the agreement, we granted to Alexion an exclusive research license, with limited sublicensing rights, to make and use our Xtend technology to evaluate and advance compounds against six different target programs during a five‑year research term under the agreement, up to completion of the first multi‑dose human clinical trial for each target compound. Alexion may extend the research term for an additional three years upon written notice to us and payment of an extension fee of $2.0 million. Alexion is responsible for conducting all research and development activities under the agreement at its own expense. |
In addition, we granted to Alexion an exclusive option, on a target‑ by‑target basis, to obtain an exclusive commercial, worldwide, royalty‑ bearing license, with sublicensing rights, under our Xtend technology to develop and commercialize products that contain the target for which the option is exercised. In order to exercise this option, Alexion must pay a $4.0 million option fee with respect to each target for which the option is exercised. Alexion may exercise this option at any time during the research term but must exercise it prior to initiating a second clinical trial with a target that includes our technology. |
Under the agreement, we received an upfront payment of $3.0 million. Alexion is also required to pay an annual maintenance fee of $0.5 million during the research term of the agreement and $1.0 million during any extension of the research term. In addition, if certain development, regulatory and commercial milestones are achieved, we are eligible to receive up to $66.5 million for the first product to achieve such milestones on a target‑by‑target basis. If licensed products are successfully commercialized, we are also entitled to receive royalties based on a percentage of net sales of such products sold by Alexion, its affiliates or its sublicensees, which percentage is in the low single digits. Alexion’s royalty obligations continue on a product‑by‑product and country‑by‑ country basis until the expiration of the last‑to‑expire valid claim in a licensed patent covering the applicable product in such country. |
Absent early termination, the term of the agreement will continue until the expiration of Alexion’s royalty payment obligations or until the expiration of the research term if Alexion has not exercised its option for a product license under the agreement. Either party may terminate the agreement for a material breach of the agreement by the other party if such breach remains uncured for 60 days, or 30 days in the case of a non‑payment breach. Alexion may terminate the agreement without cause on a target‑by‑target basis upon 90 days’ advance written notice to us. |
The total revenue recognized under this arrangement was $1.0 million and $0.9 million for the years ended December 31, 2014 and 2013 respectively. As of December 31, 2014 we have deferred revenue related to this agreement of $1.6 million. |
Amgen, Inc. |
In December 2010, we entered into a Collaboration and Option Agreement with Amgen, Inc. (Amgen), pursuant to which we agreed to collaborate with Amgen to research, develop and commercialize XmAb5871 and products based thereon. Under the agreement, we granted to Amgen an option to acquire an exclusive license to research, develop, manufacture and commercialize XmAb5871 and certain related products worldwide, which option is exercisable by Amgen only after Amgen’s (1) notification to us that it is electing to exercise the option and (2) payment of an option exercise fee to us during the option period under the agreement. The term of the option began at the effective date of the Agreement and expires 90 days after delivery of the data from a Phase 2 proof‑of‑concept (POC) clinical trial. During the option period and prior to Amgen exercising its option under the agreement, we retain ownership of the compound and are responsible for all clinical development of the compound through completion of the Phase 2 POC clinical trial and delivery of the clinical study data for the POC clinical trial. We received a nonrefundable upfront payment of $11.0 million upon execution of the agreement and a $2.0 million payment in January 2013 upon initiation of a Phase 1b trial. We determined that substantially all of the future milestones and related payments were substantive and contingent and we did not allocate any of the upfront consideration to the milestones. |
We determined that the arrangement is one with multiple deliverables and we identified the multiple elements at the inception of the agreement. We determined that the deliverables under the arrangement were the research and development services and the option to acquire the rights to XmAb5871. Since the option is a contingent and a substantive element, no portion of the upfront fee was allocated to it. The upfront payment was allocated to the research and development services and is being recognized ratably over the estimated service period to complete the Phase 2 POC trial and delivery of the clinical study reports to Amgen. We have estimated that the term of the service period to be 72 months from inception of the agreement through completion of the POC trial. |
In October 2014, we entered into an agreement with Amgen to terminate the Collaboration Agreement pursuant to which all worldwide rights to develop and commercialize XmAb5871 reverted back to us. Our obligations to continue development of XmAb5871 under the terms of the Collaboration Agreement terminated effective as of the date of the termination agreement. As a result of and effective as of the date of the termination agreement, all of Amgen’s rights to XmAb5871 terminated including the right to exercise an exclusive option to acquire the worldwide rights to XmAb5871. Amgen’s obligations to make any further payments to us are also terminated. In connection with the termination, we granted Amgen a right of first negotiation (ROFN) to obtain an exclusive license to develop and commercialize any XmAb5871 product. |
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The ROFN requires us to notify Amgen if we decide to pursue a licensing transaction with a third party involving XmAb5871. Upon receipt of the notification, Amgen will have a limited time to review the data from XmAb5871 and enter into negotiations to obtain an exclusive license to develop and commercialize any future XmAb5871 product. The ROFN will expire upon the earlier of: (1) October 27, 2019, (2) initiation by us of a Phase 3 clinical trial with XmAb5871 or (3) the transfer or sale to a third party of substantially all of our business. |
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We have determined that the termination results in a cancellation of all our obligations to Amgen under the Collaboration Agreement. We have evaluated the terms of the ROFN and determined that it has de minimis value because Amgen’s rights under the ROFN are limited to an exclusive negotiating period of a short duration and there is no bargain element in the ROFN. As a result of the termination, we have recognized $5.2 million of income which represents the balance of the deferred revenue related to the agreement at the time of the termination. |
The total revenue recognized under this arrangement was $6.9 million, $2.2 million and $1.8 million for the years ended December 31, 2014, 2013 and 2012, respectively. As of December 31, 2014 we have no deferred revenue related to this agreement. |
MedImmune LLC |
In December 2012, we entered into a Cross‑License Agreement with MedImmune, LLC (MedImmune). Under the agreement we provided MedImmune with a non‑exclusive research license to certain technology and options to acquire commercial licenses to a limited number of compounds. In exchange, MedImmune provided us with a worldwide, non‑exclusive, royalty‑free license and sub‑license to certain U.S. patent rights granted to MedImmune. We determined that the exchange is a non‑monetary transaction as provided under ACS 845‑10, Non‑Monetary Transactions. The transaction did not include any cash proceeds and only the exchange of intellectual property rights between the two companies. |
We estimated the fair value of the license and options transferred to be $0.75 million. Our estimate was based on the risk adjusted discounted cash flow that is associated with the research license and options to commercial licenses transferred to MedImmune. We recognized licensing revenue on the exchange of $0.75 million for the year ended December 31, 2012 equal to the fair value of the assets transferred. We also recorded an asset of $0.75 million to reflect the licensing rights that we acquired from MedImmune in the exchange; the capitalized rights are being amortized over the shorter of the remaining patent term or the estimated useful life of the license. |
MedImmune Ventures, Inc., an affiliate of MedImmune, was one of our 5% stockholders and has a designee on our Board of Directors as of December 31, 2012. As a result of our Initial Public Offering that became effective December 2013, MedImmune was no longer a 5% stockholder. |
Boehringer Ingelheim International GmbH |
In 2007 we entered into a Research Licensee and Collaboration Agreement with Boehringer Ingelheim International GmbH (BI). Under the agreement, we provided BI with a three‑year research license to one of our technologies and commercial options. We identified the deliverables under the agreement at inception as the research licenses and options to acquire commercial licenses to up to two compounds. Upon exercise of an option to a commercial license, we are eligible to receive future milestone payments and royalties. We determined that the future milestones and related payments were substantive and contingent and we did not allocate any of the upfront consideration to the milestones. The upfront payment and the annual license fees are being recognized ratably into income over the research license term which expired in 2011 and payments for the commercial options were recognized in the period the commercial option was exercised since the options were contingent and substantive. During 2012, BI advanced a compound that incorporates our technology into clinical development and we received a milestone payment of $1.2 million and recognized the payment as revenue in the period the milestone event occurred. No revenue related to this arrangement was recognized in 2014 or 2013. There is no deferred revenue related to this agreement at December 31, 2104. |
Janssen, Research & Development, LLC |
In 2009 we entered into a Research License and Option Agreement with Janssen, Research & Development, LLC (Janssen). Under the agreement, we provided Janssen with non‑exclusive research license and options for exclusive commercial licenses to apply our technology to their compounds. We identified the deliverables under the agreement at inception as the research licenses and options to acquire commercial licenses to up to three compounds. Upon exercise of an option, we are eligible to receive future milestone and royalty payments. We determined that the options and future milestones and related payments were substantive and contingent and we did not allocate any of the upfront consideration to the options or milestones. The upfront payment of $1.0 million received at inception and the annual research license renewal payments are being recognized as revenue recorded ratably over the two‑year term of the research license. During 2012, we recognized total revenue of $1.4 million consisting of $0.9 million in research license revenue and $0.5 million for the exercise of a commercial option. No revenues related to this arrangement were recognized in 2014 and 2013. There is no deferred revenue related to this agreement at December 31, 2104. |
CSL Limited |
In 2009 we entered into a Research License and Commercialization Agreement with CSL Limited (CSL-2009). Under the agreement, we provided CSL with a research license to one of our technologies and up to five commercial options. The upfront payment of $0.75 million received at inception and the annual research license renewal payments were recognized as revenue ratably over the five‑year term of the research license. During 2012, we recognized total revenue of $1.8 million consisting of $0.3 million in annual research license revenue and $1.5 million in milestone payments. We identified the deliverables under the agreement at inception as the five‑year research licenses and options to acquire commercial licenses. |
In May 2013, we entered into an amendment to a February 2009 Research License and Commercialization Agreement with CSL, which eliminated a contingent milestone payment requirement and reduced the royalty rate on net sales for a product in development. The amendment provided for a payment upon signing of $2.5 million. We determined that the amendment was a material modification to the original agreement and evaluated the remaining deliverables at the date of the amendment. We determined that the remaining deliverables were the research license which expires in February 2014 and four additional options to take commercial licenses through the term of the research period. The options were considered to be substantive and contingent and we did not allocate any of the proceeds received in the amendment to the options. The amendment proceeds were recognized into income over the remaining period of the research term. Total revenue recognized for the years ended December 31, 2014, 2013 and 2012 was $0.7 million, $2.4 million and $1.8 million respectively. As of December 31, 2014 we have no deferred revenue related to this agreement. |
In March 2013, we entered into a License Agreement with CSL Limited (CSL-2013). Under the terms of the agreement, we provided CSL with a non‑exclusive commercial license to apply our technology to one of their compounds. The agreement provided for upfront payment of $0.5 million and we are eligible to receive future milestones as CSL advances the compound into clinical development. We determined that the deliverables under this agreement were the non‑exclusive commercial license. We determined that the future milestones and related payments were substantive and contingent and we did not allocate any of the upfront consideration to the milestones. We recognized zero and $0.5 million of revenue related to this agreement for the year ended December 31, 2014 and 2013, respectively. There is no deferred revenue related to this agreement at December 31, 2014. |
Merck Sharp & Dohme Corp. |
In July 2013, we entered into a License Agreement with Merck Sharp & Dohme Corp (Merck). Under the terms of the agreement, we provided Merck with a non‑exclusive commercial license to certain patent rights to our Fc domains to apply to one of their compounds. We also provided Merck with contingent options to take additional non‑exclusive commercial licenses. The contingent options provide Merck an opportunity to take non‑exclusive commercial licenses at an amount less than the amount paid for the original license. The agreement provided for an upfront payment of $1.0 million and annual maintenance fees totaling $0.5 million. We are also eligible to receive future milestones and royalties as Merck advances the compound into clinical development. |
We determined that the deliverables under this agreement were the non‑exclusive commercial license and the options. The options are considered substantive and contingent and no amount of the upfront payment was allocated to these options. We also determined that the future milestones and related payments were substantive and contingent and did not allocate any of the upfront payment to the milestones. |
In the first quarter of 2014, Merck initiated a Phase 1 clinical trial which triggered a $0.5 million milestone payment to us. For the years ended December 31, 2014 and 2013 total revenue recognized was $0.6 million and $1.0 million respectively. As of December 31, 2014, we had deferred revenue of $0.1 million related to this agreement. |
As of December 31, 2014, the Company may be eligible to receive the following maximum payments from its collaborative partners and licensees based upon contractual terms in the agreements assuming all options are exercised and all milestones are achieved: |
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| | Potential Milestones (in millions) (1) | |
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Partner | | Development-based | | Regulatory-based | | Sales-based | | Milestones | |
MorphoSys | | $ | 62.0 | | $ | 187.0 | | $ | 50.0 | | $ | 299.0 | |
Alexion | | | 51.0 | | | 168.0 | | | 180.0 | | | 399.0 | |
BI | | | 9.0 | | | 6.0 | | | 12.0 | | | 27.0 | |
CSL 2009 | | | 6.0 | | | 4.0 | | | 5.0 | | | 15.0 | |
CSL 2013 | | | 8.0 | | | 4.0 | | | 24.5 | | | 36.5 | |
Merck | | | 3.5 | | | 6.0 | | | — | | | 9.5 | |
Novo Nordisk | | | 36.3 | | | 51.0 | | | 80.0 | | | 167.3 | |
Janssen | | | 6.0 | | | — | | | 4.0 | | | 10.0 | |
Total | | $ | 181.8 | | $ | 426.0 | | $ | 355.5 | | $ | 963.3 | |
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| -1 | | The payments are solely dependent upon activities of the collaborative partner or licensee. | | | | | | | | | | |
The $9.5 million, $10.2 million and $9.5 million of revenue recorded for the years ended December 31, 2014, 2013 and 2012, respectively was earned principally from the following licensees (in millions): |
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| | Year Ended | | | |
| | December 31, | | | |
| | 2014 | | 2013 | | 2012 | | | | |
Amgen | | $ | 6.9 | | $ | 2.2 | | $ | 1.8 | | | | |
MorphoSys | | | — | | | 3.0 | | | 2.0 | | | | |
Janssen | | | — | | | — | | | 1.4 | | | | |
Merck | | | 0.6 | | | 1.0 | | | — | | | | |
Alexion | | | 1.0 | | | 0.9 | | | — | | | | |
CSL | | | 0.7 | | | 2.9 | | | 1.8 | | | | |
BI | | | — | | | — | | | 1.2 | | | | |
Other | | | 0.3 | | | 0.2 | | | 1.3 | | | | |
Total | | $ | 9.5 | | $ | 10.2 | | $ | 9.5 | | | | |
As of December 31, 2014 and 2013 our accounts receivable included $3.0 million and $0.1 million from Novo Nordisk A/S and MorphoSys AG respectively. |
A substantial portion of our revenue is earned from collaboration partners outside the United States. Non‑U.S. revenue is denominated in U.S. dollars. A breakdown of our revenue from U.S. and Non‑U.S. sources for the years ended December 31, 2014, 2013 and 2012 is as follows (in millions): |
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| | Year Ended | | | | |
| | December 31, | | | | |
| | 2014 | | 2013 | | 2012 | | | | |
U.S. Revenue | | $ | 8.6 | | $ | 4.2 | | $ | 4.4 | | | | |
Non-U.S. Revenue | | | 0.9 | | | 6.0 | | | 5.1 | | | | |
Total | | $ | 9.5 | | $ | 10.2 | | $ | 9.5 | | | | |
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Deferred Revenue | | | | | | | | | | | | | | |
| | Year Ended | | | | |
| | December 31, | | | | |
| | 2014 | | 2013 | | 2012 | | | | |
U.S. Revenue | | $ | 8.6 | | $ | 4.2 | | $ | 4.4 | | | | |
Non-U.S. Revenue | | | 0.9 | | | 6.0 | | | 5.1 | | | | |
Total | | $ | 9.5 | | $ | 10.2 | | $ | 9.5 | | | | |
Deferred Revenue |
Deferred revenue arises from payments received in advance of the culmination of the earnings process. We have classified deferred revenue expected to be recognized within the next 12 months as a current liability. We recognize deferred revenue as revenue in future periods when the applicable revenue recognition criteria have been met. The total amounts reported as deferred revenue were $4.6 million and $9.7 million for the years ended December 31, 2014 and 2013, respectively. |
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Research and Development Expenses | Research and Development Expenses |
Research and development expenses include costs we incur for our own and for our collaborators research and development activities. Research and development costs are expensed as incurred. These costs consist primarily of salaries and benefits, including associated stock‑based compensation, laboratory supplies, facility costs, and applicable overhead expenses of personnel directly involved in the research and development of new technology and products, as well as fees paid to other entities that conduct certain research development activities on our behalf. We estimate preclinical study and clinical trial expenses based on the services performed pursuant to the contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on our behalf based on the actual time and expenses incurred by them. Further, we accrue expenses related to clinical trials based on the level of patient enrollment and activity according to the related agreement. We monitor patient enrollment levels and related activity to the extent reasonably possible and adjust estimates accordingly. During 2014, 2013 and 2012 we expensed $18.5 million, $17.0 million and $12.7 million, respectively, for research and development. |
We capitalize acquired research and development technology licenses and third‑party contract rights and amortize the costs over the shorter of the license term or the expected useful life. We review the license arrangements and the amortization period on a regular basis and adjust the carrying value or the amortization period of the licensed rights if there is evidence of a change in the carrying value or useful life of the asset. See “Patents, licenses and other intangible assets.” |
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Cash and Cash Equivalents | Cash and Cash Equivalents |
We consider cash equivalents to be only those investments which are highly liquid, readily convertible to cash and which mature within three months from the date of purchase. |
The primary objectives for our investment portfolio are liquidity and safety of principal. Investments are made to achieve the highest rate of return for us, while maintaining consistency with these two objectives. |
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Concnetrations of Risk | Concentrations of Risk |
Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. We have never experienced any losses related to these balances. Amounts on deposit in excess of federally insured limits at December 31, 2014 and 2013 approximated $54.0 million and $77.5 million, respectively. |
We have payables with one service provider that represents 47% of our total payables and five service providers that represented 57% of our total payables for the years ended December 31, 2014 and 2013, respectively. We rely on two critical suppliers for the manufacture of our drug product for use in our clinical trials. While we believe that there are alternative vendors available, a change in manufacturing vendors could cause a delay in the availability of drug product and result in a delay of conducting and completing our clinical trials. No other vendor accounted for more than 10.0% of payables at December 31, 2014 and 2013. |
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Fair Value of Financial Instruments | Fair Value of Financial Instruments |
Our financial instruments primarily consist of cash, money market funds, trade accounts receivable, accounts payable, accrued expenses and convertible notes payable. The fair value of cash, money market funds, trade accounts receivable, accounts payable and accrued expenses closely approximate their carrying value due to their short maturities. The carrying amounts of convertible notes payable approximate their fair value, as the interest rates, in consideration of the conversion feature, approximate the interest rates presently available to us. |
We determine the fair value of the principal amount of financial and nonfinancial assets and liabilities using the fair value hierarchy, which describes three levels of inputs that may be used to measure fair value, as follows: |
Level 1—Quoted prices in active markets for identical assets or liabilities; |
Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and |
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
There are no fair value assets or liabilities. |
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Property and Equipment | Property and Equipment |
Property and equipment are recorded at cost and depreciated using the straight‑line method over the estimated useful lives of the assets, ranging from three to seven years, or the lease term, whichever is shorter. Expenditures for repairs and maintenance are charged to expense as incurred while renewals and improvements are capitalized. Useful lives by asset category are as follows: |
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Computers, software and equipment | | 3 - 5 years | | | | | | | | | | | |
Furniture and fixtures | | 5 - 7 years | | | | | | | | | | | |
Leasehold improvements | | 5 - 7 years or remaining | | | | | | | | | | | |
| | lease term, whichever is less | | | | | | | | | | | |
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Patents, Licenses, and Other Intangible Assets | Patents, Licenses, and Other Intangible Assets |
The cost of acquiring licenses is capitalized and amortized on the straight‑ line basis over the shorter of the term of the license or its estimated economic life, ranging from five to 25 years. Third‑party costs incurred for acquiring patents are capitalized. Capitalized costs are accumulated until the earlier of the period that a patent is issued or we abandon the patent claims. Cumulative capitalized patent costs are amortized on a straight‑line basis from the date of issuance over the shorter of the patent term or the estimated useful economic life of the patent, ranging from 13 to 20 years. Our senior management, with advice from outside patent counsel, assesses three primary criteria to determine if a patent will be capitalized initially: i) technical feasibility, ii) magnitude and scope of new technical function covered by the patent compared to the company’s existing technology and patent portfolio, particularly assessing the value added to our product candidates or licensing business, and iii) legal issues, primarily assessment of patentability and prosecution cost. We review our intellectual property on a regular basis to determine if there are changes in the estimated useful life of issued patents and if any capitalized costs for unissued patents should be abandoned. Capitalized patent costs related to abandoned patent filings are charged off in the year of the decision to abandon. During 2014, 2013 and 2012, we abandoned previously capitalized patent and licensing related charges of $509,000, $205,000 and $388,000, respectively. |
The carrying amount and accumulated amortization of patents, licenses, and other intangibles is as follows (in thousands): |
| | | | | | | | | | | | | |
| | December 31, | | | | | | | |
| | 2014 | | 2013 | | | | | | | |
Patents, definite life | | $ | 5,720 | | $ | 4,834 | | | | | | | |
Patents, pending issuance | | | 3,654 | | | 3,515 | | | | | | | |
Licenses and other amortizable intangible assets | | | 1,797 | | | 1,917 | | | | | | | |
Nonamortizable intangible assets (trademarks) | | | 400 | | | 369 | | | | | | | |
Total gross carrying amount | | | 11,571 | | | 10,635 | | | | | | | |
Accumulated amortization—patents | | | -1,776 | | | -1,395 | | | | | | | |
Accumulated amortization—licenses and other | | | -679 | | | -426 | | | | | | | |
Total intangible assets, net | | $ | 9,116 | | $ | 8,814 | | | | | | | |
Amortization expense for patents, licenses, and other intangible assets was $694,000, $598,000 and $373,000 for the years ended December 31, 2014, 2013 and 2012, respectively. |
Future amortization expense for patents, licenses, and other intangible assets recorded as of December 31, 2014, and for which amortization has commenced, is as follows: |
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| | Years ending | | | | | | | | | | |
| | December 31, | | | | | | | | | | |
| | (in thousands) | | | | | | | | | | |
2015 | | $ | 535 | | | | | | | | | | |
2016 | | | 538 | | | | | | | | | | |
2017 | | | 538 | | | | | | | | | | |
2018 | | | 527 | | | | | | | | | | |
2019 | | | 515 | | | | | | | | | | |
Thereafter | | | 2,408 | | | | | | | | | | |
Total | | $ | 5,061 | | | | | | | | | | |
The above amortization expense forecast is an estimate. Actual amounts of amortization expense may differ from estimated amounts due to additional intangible asset acquisitions, impairment of intangible assets, accelerated amortization of intangible assets, and other events. As of December 31, 2014, the Company has $3.7 million of intangible assets which are in‑process and have not been placed in service and, accordingly amortization on these assets has not commenced. |
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Long-Lived Assets | Long‑Lived Assets |
Management reviews long‑lived assets which include fixed assets and certain identifiable intangibles for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset (or asset group) may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Fair value for our long‑lived assets is determined using the expected cash flows discounted at a rate commensurate with the risks involved. |
As of December 31, 2014, we determined that our continuing losses from operations triggered a review of the carrying value of our long‑lived assets including our capitalized patent and licensing costs. We conducted an impairment analysis of the assets in accordance with ASC 360 by estimating the future undiscounted cash flows as of December 31, 2014, by patent family, which included granted and pending patents and related licenses. For purposes of the analysis, we grouped our patents into the four primary technology groups, IIb, ADCC, Xtend and, bi‑specific, and compared the carrying value of the group to the undiscounted cash flows expected to be received from the patents in each group. We determined that the fair value of the potential future cash flows using this method was in excess of the carrying value of the intangible assets as of December 31, 2014. The patent groups assessed for impairment were the IIb, ADCC, Xtend and bi‑specific patent families and represented the lowest level of cash flows for evaluation. These four patent families cover all of our current product candidates and our current license agreements. We modeled the cash flows from our internal product development program XmAb7195 and licensed programs that use each particular category of patent asset. We used multiple published sources of pharmaceutical product development stage failure rates to estimate failure rates at each stage of clinical development in order to probability weight the cash flows for each internal and licensed program. We did not recognize a loss from impairment for the years ended December 31, 2014, 2013 or, 2012. |
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Income Taxes | Income Taxes |
We account for income taxes in accordance with accounting guidance which requires an asset and liability approach to financial accounting and reporting for income taxes. Deferred income tax assets and liabilities are computed annually for differences between the financial statement and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable or refundable for the period plus or minus the change during the period in deferred tax assets and liabilities. |
We assess our income tax positions and record tax benefits for all years subject to examination based upon our evaluation of the facts, circumstances and information available at the reporting date. For those tax positions where there is greater than 50% likelihood that a tax benefit will be sustained, we have recorded the largest amount of tax benefit that may potentially be realized upon ultimate settlement with a taxing authority that has full knowledge of all relevant information. For those income tax positions where there is a 50% or less likelihood that a tax benefit will be sustained, no tax benefit has been recognized in the financial statements. |
Our policy is to recognize interest and penalties on taxes, if any, as a component of income tax expense. We did not have any uncertain tax positions at December 31, 2014 or 2013. |
We are potentially subject to tax authority audits for the years 2011 and onwards for U.S. federal purposes and 2010 and onwards for state purposes. |
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Stock-Based Compensation | Stock‑Based Compensation |
We recognize compensation expense using a fair‑value‑based method for costs related to all share‑based payments, including stock options and shares issued under our Employee Stock Purchase Plan (“ESPP”). Stock‑based compensation cost related to employees and directors is measured at the grant date, based on the fair‑value—based measurement of the award using the Black‑Scholes method, and is recognized as expense over the requisite service period on a straight‑line basis. We are required to estimate forfeitures at the time of grant and revise those estimates in subsequent period if actual forfeitures differ from those estimates. We use historical data and industry published statistics to estimate pre‑vesting option forfeitures and record stock‑based compensation expense only for those awards that are expected to vest. We recorded stock‑based compensation (benefit) and expense for stock‑based awards to employees, directors and consultants of approximately $1.8 million, $198,000 and $29,000 for the years ended December 31, 2014, 2013 and 2012, respectively. Included in the 2014 total compensation expense is $172,000 under our ESPP. |
Options granted to individual service providers that are not employees or directors are accounted for at estimated fair value using the Black‑Scholes option‑pricing method and are subject to periodic re‑measurement over the period during which the services are rendered. |
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Net Loss Per Share | Net Loss Per Share |
Basic net loss per common share is computed by dividing the net loss by the weighted‑average number of common shares outstanding during the period. Potentially dilutive securities consisting of stock options at December 31, 2014, 2013 and 2012, and convertible preferred stock and convertible promissory notes at December 31, 2012 and 2011 were not included in the diluted net loss per common shares calculation because the inclusion of such shares would have had an antidilutive effect. |
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| | Year Ended | | | | | | | |
| | December 31, | | | | | | | |
| | 2014 | | 2013 | | 2012 | | | | | | | |
| | (in thousands) | | | | | | | |
Convertible preferred stock | | — | | — | | 12,188 | | | | | | | |
Convertible promissory notes | | — | | — | | 2,800 | | | | | | | |
Options to purchase common stock | | 2,827 | | 1,794 | | 1,305 | | | | | | | |
Employee stock purchase plan shares | | 25 | | — | | — | | | | | | | |
Total | | 2,852 | | 1,794 | | 16,293 | | | | | | | |
The loss for the period ended December 31, 2013 was adjusted, for purposes of the diluted net income per share calculation, to reflect the deemed contribution of $144.8 million. This reflects a deemed contribution of $148.1 million from the exchange of convertible preferred stock, a deemed dividend of $1.0 million for the difference between the fair value of the shares of Series A‑1 convertible preferred stock and the price at which shares were sold in June 2013, and an additional deemed dividend of $2.3 million for the difference between the fair value of the shares of Series A‑1 convertible preferred stock and the price at which additional shares were sold in the subsequent Series A‑1 closing in September 2013. |
For 2013, the diluted loss per share calculation assumes the conversion of outstanding shares of convertible preferred stock into common stock using the as‑if converted method. |
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| | Year Ended December 31 | | |
| | 2014 | | 2013 | | 2012 | | |
| | (in thousands, except | | |
| | per share data) | | |
Basic | | | | | | | | | | | |
Numerator: | | | | | | | | | | | |
Net loss | | $ | -16,422 | | $ | -60,259 | | $ | -8,594 | | |
Deemed contribution | | | — | | | 144,765 | | | — | | |
Net income (loss) attributable to common stockholders for basic income per share | | $ | -16,422 | | $ | 84,506 | | $ | -8,594 | | |
Denominator: | | | | | | | | | | | |
Weighted-average common shares outstanding | | | 31,390,631 | | | 2,472,581 | | | 72,302 | | |
Basic net income (loss) per common share | | $ | -0.52 | | $ | 34.18 | | $ | -118.86 | | |
Diluted: | | | | | | | | | | | |
Numerator: | | | | | | | | | | | |
Net income (loss) attributable to common stockholders for basic net loss per share | | $ | -16,422 | | $ | 84,506 | | $ | -8,594 | | |
Deemed contribution | | | — | | | -144,765 | | | — | | |
Net loss attributable to common stockholders for diluted net loss per share | | $ | -16,422 | | $ | -60,259 | | $ | -8,594 | | |
Denominator: | | | | | | | | | | | |
Weighted average number of common shares outstanding used in computing basic net (loss) income per common share | | | 31,390,631 | | | 2,472,581 | | | 72,302 | | |
Dilutive effect of conversion of convertible preferred stock | | | — | | | 13,173,208 | | | — | | |
Weighted-average number of common shares outstanding used in computing net loss per common share | | | 31,390,631 | | | 15,645,789 | | | 72,302 | | |
Diluted net loss per common share | | $ | -0.52 | | $ | -3.85 | | $ | -118.86 | | |
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Segment Reporting | | | | | | | | | | | | |
| | Year Ended December 31 | | |
| | 2014 | | 2013 | | 2012 | | |
| | (in thousands, except | | |
| | per share data) | | |
Basic | | | | | | | | | | | |
Numerator: | | | | | | | | | | | |
Net loss | | $ | -16,422 | | $ | -60,259 | | $ | -8,594 | | |
Deemed contribution | | | — | | | 144,765 | | | — | | |
Net income (loss) attributable to common stockholders for basic income per share | | $ | -16,422 | | $ | 84,506 | | $ | -8,594 | | |
Denominator: | | | | | | | | | | | |
Weighted-average common shares outstanding | | | 31,390,631 | | | 2,472,581 | | | 72,302 | | |
Basic net income (loss) per common share | | $ | -0.52 | | $ | 34.18 | | $ | -118.86 | | |
Diluted: | | | | | | | | | | | |
Numerator: | | | | | | | | | | | |
Net income (loss) attributable to common stockholders for basic net loss per share | | $ | -16,422 | | $ | 84,506 | | $ | -8,594 | | |
Deemed contribution | | | — | | | -144,765 | | | — | | |
Net loss attributable to common stockholders for diluted net loss per share | | $ | -16,422 | | $ | -60,259 | | $ | -8,594 | | |
Denominator: | | | | | | | | | | | |
Weighted average number of common shares outstanding used in computing basic net (loss) income per common share | | | 31,390,631 | | | 2,472,581 | | | 72,302 | | |
Dilutive effect of conversion of convertible preferred stock | | | — | | | 13,173,208 | | | — | | |
Weighted-average number of common shares outstanding used in computing net loss per common share | | | 31,390,631 | | | 15,645,789 | | | 72,302 | | |
Diluted net loss per common share | | $ | -0.52 | | $ | -3.85 | | $ | -118.86 | | |
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Segment Reporting |
The Company determines its segment reporting based upon the way the business is organized for making operating decisions and assessing performance. The Company has only one operating segment related to the development of pharmaceutical products. |
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