The Medicines Company Reports First Quarter 2015 Financial Results and Operational Developments
Company records six regulatory approvals in US and EU in 2015
IONSYS® – on
April 30, 2015, the FDAapproved IONSYS® (fentanyl iontophoretic transdermal system), the first needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital.
Raplixa™ - on
April 30, 2015the FDAapproved RAPLIXA™ (fibrin sealant) and the RaplixaSpray™ (Raplixa™ Delivery Device) to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.
RPX-602 – on
April 17, 2015, the FDAapproved the sNDA for a new formulation of MINOCIN® (minocycline) for Injection. In addition, the FDAdesignated RPX-602 as a qualified infectious disease product (QIDP) under the GAIN Act.
Kengreal™ (cangrelor) – on
April 15, 2015, the FDA Advisory Committeerecommended by a vote of 9-2 (with one abstention) that the FDAapprove the investigational intravenous antiplatelet agent cangrelor as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural thrombotic events such as myocardial infarction (MI), stent thrombosis (ST) and ischemia-driven revascularization. The PDUFA date is June 23, 2015.
March 2015, the European Commissiongranted marketing authorization for three of The Medicines Company’s hospital acute care products – Kengrexal™ (cangrelor), Orbactiv®, and Raplixa™.
February 2015, the Company completed its acquisition of Annovation BioPharma, Inc., a company focused on creating more effective, safer therapies for anesthesia and critical care. Based on technology licensed from Massachusetts General Hospital, Annovation is developing ABP-700, a novel intravenous anesthetic which in Phase 1 clinical studies has demonstrated potent and rapidly reversible anesthetic effects.
February 2015, the Company completed its acquisition of Recothrom® Thrombin, topical (recombinant) from Bristol-Myers Squibb Company.
Financial highlights for the first quarter of 2015:
Worldwide net revenue decreased by 29% to
Worldwide Angiomax® (bivalirudin)/Angiox® (bivalirudin) revenue, was
down 35% to
$100.7in the first quarter of 2015 compared to $155.7 millionin the first quarter of 2014, with revenue in the United Statesdecreasing to $95.1 millionin the first quarter of 2015 from $146.2 millionin the first quarter of 2014.
Recothrom® Thrombin, topical (recombinant) sales increased 21% to
$16.3 millionin the United Statesin the first quarter of 2015, as compared to $13.5 millionin the first quarter of 2014.
Other products including Cleviprex® (clevidipine), Argatroban RTU,
Minocin® (minocycline) for injection, Orbactiv® and
PreveLeakTM recorded sales of
$9.6 millionduring first quarter of 2015, compared to $8.0 millionin the first quarter of 2014.
- Excluding Angiomax, the Company recorded an increase of 20% in GAAP revenue.
In January, the Company completed an offering of
$400Min principal amount of 2.50% convertible senior notes due 2022.
Included in other income for the first quarter of 2015 is a
Net income for the first quarter of 2015 was
Adjusted net income(1) for the first quarter of 2015 was
(1) Adjusted net income and adjusted earnings per share are non-GAAP financial performance measures with no standardized definitions under US GAAP. For further information and a detailed reconciliation, refer to the Non-GAAP Financial Performance Measures and Reconciliations of GAAP to Adjusted Net income sections of this release for explanations of the amounts excluded and included to arrive at adjusted net income and adjusted earnings per share amounts.
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NON-GAAP FINANCIAL PERFORMANCE MEASURES
In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted net income and adjusted earnings per share measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information.
Adjusted net income excludes upfront collaboration payments,
amortization of acquired intangible assets and other charges, deal
related charges, restructuring charges, stock-based compensation
expense, changes in contingent consideration, arbitration award,
milestone payments, non-cash interest, impairment charges, gain on
settlement, loss on equity investment, gain on re-measurement of equity
investment, and net income tax adjustments. See the attached
Reconciliations of GAAP to Adjusted Net Income and Adjusted Earnings Per
Share for explanations of the amounts excluded and included to arrive at
adjusted net income and adjusted earnings per share amounts for the
three month ended
These adjusted measures are non-GAAP and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways.
Forward Looking Statements
Statements contained in this press release about The
|The Medicines Company|
|Consolidated Statements of Income|
|(in thousands, except per share data)||Three months ended March 31,|
|Cost of revenue||33,737||66,867|
|Research and development||23,949||31,096|
|Selling, general and administrative||80,534||64,521|
|Total operating expenses||138,220||162,484|
|Loss (income) from operations||(11,704||)||14,751|
|Co-promotion and license income||8,388||6,020|
|Gain on re-measurement of equity investment||22,741||—|
|Loss in equity investment||(144||)||—|
|Income before income taxes||10,783||17,090|
|Provision for income taxes||(5,777||)||(22,095||)|
|Net income (loss)||5,006||(5,005||)|
|Net loss attributable to non-controlling interest||28||9|
|Net income (loss) attributable to The Medicines Company||$||5,034||$||(4,996||)|
|Earnings (loss) per common share attributable to The Medicines Company:|
|Weighted average number of common shares outstanding:|
|Balance Sheet Items|
|(in thousands)||March 31,||December 31,|
|Cash and cash equivalents||$||607,073||$||370,741|
|Convertible senior notes (due 2017 and due 2022*)||$||562,725||$||246,676|
|The Medicines Company stockholders' equity||$||1,001,879||$||920,565|
* Convertible senior notes due 2022 issued on
|The Medicines Company|
|Reconciliation of GAAP to Adjusted Net Income and Adjusted Earnings Per Share|
|Three months ended March 31,|
|Net income (loss) attributable to The Medicines Company - GAAP||$||5,034||$||(4,996||)|
|Before tax adjustments:|
|Cost of revenue:|
|Share-based compensation expense||(1)||196||82|
|Amortization of acquired intangible assets||(2)||6,410||5,090|
|Research and development:|
|Share-based compensation expense||(1)||931||1,333|
|Selling, general and administrative:|
|Share-based compensation expense||(1)||6,491||5,957|
|Amortization of acquired intangible assets||(2)||62||1,547|
|Change in contingent purchase price||(3)||1,420||2,264|
|Non-cash interest expense||(4)||5,516||2,914|
|Gain on remeasurement of equity investment||(5)||(22,741||)||—|
|Loss in equity investment||(6)||144||—|
|Net income tax adjustments||(7)||2,213||7,918|
|Net income attributable to The Medicines Company - Adjusted||$||5,676||$||22,109|
|Net income per share attributable to The Medicines Company - Adjusted|
|Weighted average number of common shares outstanding:|
|Diluted - Adjusted||(8)||66,873||66,654|
Explanation of Adjustments:
(1) Excludes share-based compensation of
(2) Excludes amortization of intangible assets and other charges resulting from transactions with Nycomed, CSL, APP, Teva, Targanta, BMS, Rempex and Tenaxis.
(3) Excludes changes in contingent purchase price due to shareholders of Targanta, Incline Therapeutics, ProFibrix, Rempex, Tenaxis and Annovation.
(4) Excludes non-cash interest expense related to convertible senior notes.
(5) Excludes gain on remeasurement of our equity investment in Annovation.
(6) Excludes loss in equity investment.
(7) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments.
(8) Reflects impact of note hedge transactions on outstanding diluted share amounts and net income per share associated with 2017 convertible senior notes.
In addition to the financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted measures should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways.
Neera Dahiya Ravindran, MD, +1 973-290-6044
Vice President, Investor Relations & Strategic Planning
Bob Laverty, +1 973-290-6162
Cell: +1 609-558-5570
Vice President, Communications