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Business Overview</b></font></p> <p style="FONT-FAMILY: times;"><font size="2"><i>Overview</i></font></p> <p style="FONT-FAMILY: times;"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;The Company manufactures, markets, sells and distributes medical imaging products globally with operations in the United States ("U.S."), Puerto Rico, Canada and Australia and distribution relationships in Europe, Asia Pacific and Latin America. The Company provides medical imaging products, primarily focused on cardiovascular diagnostic imaging, to nuclear physicians, cardiologists, radiologists, internal medicine physicians, independent delivery networks, group purchasing organizations and technologists/sonographers working in a variety of clinical settings.</font></p> <p style="FONT-FAMILY: times;"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;The Company's principal products include:</font></p> <ul> <li style="LIST-STYLE-TYPE: none;"> <dl compact="compact"> <dt style="MARGIN-BOTTOM: -11pt; FONT-FAMILY: times;"><font size="2">&#8226;</font></dt> <dd style="FONT-FAMILY: times;"><font size="2">DEFINITY&#8212;an ultrasound contrast agent;</font> <font size="2"><br /> <br /></font></dd> <dt style="MARGIN-BOTTOM: -11pt; FONT-FAMILY: times;"><font size="2">&#8226;</font></dt> <dd style="FONT-FAMILY: times;"><font size="2">TechneLite&#8212;a generator that provides the radioisotope used to radiolabel Cardiolite and other radiopharmaceuticals;</font> <font size="2"><br /> <br /></font></dd> <dt style="MARGIN-BOTTOM: -11pt; FONT-FAMILY: times;"><font size="2">&#8226;</font></dt> <dd style="FONT-FAMILY: times;"><font size="2">Cardiolite&#8212;a myocardial perfusion imaging agent; and</font> <font size="2"><br /> <br /></font></dd> <dt style="MARGIN-BOTTOM: -11pt; FONT-FAMILY: times;"><font size="2">&#8226;</font></dt> <dd style="FONT-FAMILY: times;"><font size="2">Xenon&#8212;a radiopharmaceutical inhaled gas to assess pulmonary function and evaluate blood flow, particularly in the lungs.</font></dd></dl></li></ul> <p style="FONT-FAMILY: times;"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;In the U.S., the Company's nuclear imaging products are primarily distributed through radiopharmacy chains, with a small portion of the sales of these products also made through the Company's direct sales force to hospitals and clinics that maintain their own in-house radiopharmacies. In the U.S., sales of the Company's contrast agents are made through a direct sales force. Outside of the U.S., the Company owns five radiopharmacies in Canada and two radiopharmacies in each of Puerto Rico and Australia. The Company also maintains a direct sales force in each of these countries. In the rest of the world, the Company relies on third-party distributors to sell both nuclear imaging and contrast agent products.</font></p> <p style="FONT-FAMILY: times;"><font size="2"><i>Basis of Consolidation and Presentation</i></font></p> <p style="FONT-FAMILY: times;"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;The financial statements have been prepared in United States dollars, in accordance with accounting principles generally accepted in the United States of America ("U.S.&#160;GAAP"). The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.</font></p> <p style="FONT-FAMILY: times;"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;In the opinion of the Company's management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company's financial statements for interim periods in accordance with U.S.&#160;GAAP. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S.&#160;GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). The information included in this Quarterly Report on Form&#160;10-Q should be read in conjunction with the Company's consolidated financial statements and the accompanying notes included in the Company's Annual Report on Form&#160;10-K for the year ended December&#160;31, 2012 ("2012 Form&#160;10-K"). The Company's accounting policies are described in the "Notes to Consolidated Financial Statements" in the 2012 Form&#160;10-K and updated, as necessary, in this Form&#160;10-Q. There were no changes to the Company's accounting policies since December&#160;31, 2012. The year-end condensed consolidated balance sheet data presented for comparative purposes was derived from audited financial statements, but does not include all disclosures required by U.S.&#160;GAAP. 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BVL resumed manufacturing DEFINITY in the second quarter of 2012 and released product to the Company at the end of the second quarter of 2012. BVL has also resumed manufacturing Cardiolite products. The Company currently believes that Neurolite will again become available from BVL in the latter half of 2013.</font></p> <p style="FONT-FAMILY: times;"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;The Company continues to expedite a number of its technology transfer programs to secure and qualify production of its BVL-manufactured products with alternate contract manufacturer sites. In February 2013, the FDA informed the Company that the Jubilant HollisterStier ("JHS") facility was approved to manufacture DEFINITY, and the Company is now shipping JHS-manufactured DEFINITY to customers. The Company also has on-going technology transfer activities at JHS for its Cardiolite product supply and Neurolite but is not certain as to when that technology transfer will be completed and when the Company will actually receive supply of Cardiolite products and Neurolite from JHS. In the meantime, the Company also has an alternate manufacturer for a portion of its Cardiolite sales demand. The Company is also pursuing new manufacturing relationships to establish and secure additional long-term or alternative suppliers of its key products but is uncertain of the timing as to when any other supply arrangements would provide meaningful quantities of products to the Company.</font></p> <p style="FONT-FAMILY: times;"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;During the first quarter of 2012, the Company received $30.0&#160;million from BVL to compensate the Company for its business losses associated with the lack of product supply during the outage pursuant to a Transition Services Agreement. This payment is included within operating income as proceeds from manufacturer. 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If the Company is not successful in achieving its forecasted results, which include assumptions that BVL and JHS will manufacture and release adequate product supply on a timely and consistent basis, the Company is successful with the remainder of the JHS technology transfer programs for Cardiolite product and Neurolite and the Company is able to continue to grow DEFINITY sales, the Company could be in non-compliance with one or more of the financial ratio covenants in the Facility in the next twelve months. If this were to occur, the Company would either seek&#160;an additional amendment to the Facility or a waiver or consent in connection with the appropriate financial covenants to eliminate such potential default or seek to secure an alternative financing arrangement. There can be no assurance that the Company would be able to obtain an amendment, waiver or consent from its lenders.</font></p> <p style="FONT-FAMILY: times;"><font size="2">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;The Company has taken actions during March 2013 to substantially reduce its discretionary spending. In particular, the Company began to implement a strategic shift in how it will fund its research and development ("R&amp;D") programs. The Company will reduce during 2013 its internal R&amp;D resources, while at the same time seeking to engage one or more strategic partners to assist in the further development and commercialization of its development candidates, including flurpiridaz F&#160;18, 18F LMI 1195 and LMI 1174. The Company will complete its 301 trial for flurpiridaz F&#160;18 with internal funding while seeking to engage strategic partners to assist with the further development and possible commercialization of the agent. 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