The Medicines Company Reports Second-Quarter and First-Half 2015 Financial Results
- Commercial resources focused on new product launches
- R&D investment in potential blockbusters continues
Company contracts with
Sandozfor launch of authorized generic bivalirudin (Angiomax)
- Company exploring strategic-partnering options to accelerate business development and unlock value
Second-Quarter 2015 Financial Summary
Worldwide net revenue was
The net loss for the second quarter of 2015 was
Included in other income for the second quarter of 2015 is a
First-Half 2015 Financial Summary
Worldwide net revenue was
The net loss for the first half of 2015 was
Included in other income for the first half of 2015 is a
(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 Reconciliation 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.
Approved Product Update:
KengrealTM (cangrelor) – In June, the
U.S. Food and Drug Administration( FDA) approved Kengreal, the first and only intravenous, reversible P2Y12 platelet inhibitor, as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. The Kengreal U.S. launch team includes 85 field sales professionals who are introducing this product to the same cardiac catheterization laboratories in which they promoted Angiomax.
- Orbactiv® (oritavancin)- Formulary adoption programs continue on track, hospitals and infusion centers continue to revise care pathways to enable patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible designated Gram-positive pathogens to be treated using a single infusion. In addition, reimbursement processes are adapting to this single dose treatment approach to ABSSSI patient management.
Minocin® (minocycline) for Injection - On
April 17, 2015, the FDAapproved the sNDA for RPX-602 - a new formulation of Minocin for Injection, which allows for a lower dilution volume range to treat infections due to the susceptible strains of designated organisms, including those caused by Acinetobacter spp. In addition, the FDAdesignated RPX-602 as a qualified infectious disease product (QIDP) under the GAIN Act.
Ionsys® (fentanyl iontophoretic transdermal system) - On
April 30, 2015, the FDAapproved Ionsys, 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. Ionsys became available to the US market as anticipated in mid-July. The dedicated Ionsys U.S. launch team initially includes 65 dedicated field sales professionals. The Ionsys Risk Evaluation and Mitigation Strategy (REMS) Program to mitigate the risks of respiratory depression resulting from accidental exposure to persons for whom Ionsys is not prescribed is underway as required by the FDA.
RaplixaTM (fibrin sealant (human)) - On
April 30, 2015, the FDAapproved Raplixa and the RaplixaSpray (RAPLIXA Delivery Device) as an adjunct to 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. As stated previously, we are scaling manufacturing of Raplixa in preparation for launch.
Please see www.themedicinescompany.com for complete indication and important safety information for these products.
Investigational Product Candidates Update:
ALN-PCSsc (PCSK9) – The Phase 1 clinical study of the investigational
agent ALN-PCSsc in subjects with elevated low-density-lipoprotein
cholesterol (LDL-C) is fully enrolled. The study is examining the
effects of single or multiple subcutaneous doses of ALN-PCSsc on
safety, pharmacokinetics, serum levels of LDL-C and plasma levels.
Data from this study will be presented at the
European Society of Cardiology Congresson August 30th in London.
- MDCO-216 (ApoA-I Milano) – In May, the company presented new data from a Phase 1 clinical study which showed significant remodeling effects on HDL-cholesterol particles which may result in reduced plaque burden in patients with atherosclerotic disease. A clinical study to affirm cholesterol efflux and efflux saturation and to assess ultrasound-measured plaque regression is underway with results anticipated by the first quarter of 2016.
ABP-700 – Data presented at the 2015 Annual
Dutch Society of Anesthesiology Conferenceduring the second quarter showed the compound’s anesthetic effect and potentially advantageous onset and offset attributes as well as promising characteristics related to respiration, blood pressure and heart rate. We expect additional clinical data will be presented at the American Society of Anesthesiologistsannual meeting, October 24-28, 2015, in San Diego.
Carbavance (meropenem/RPX7009) – Patient enrollment is continuing in
the two ongoing Phase 3 TANGO clinical studies to assess the efficacy
and safety of this anti-infective combination therapy in patients with
complicated urinary tract infections including acute pyelonephritis
and in patients with carbapenem-resistant enterobacteriaceae (CRE)
infections. We expect data from multiple studies from the infectious
disease portfolio will be presented at the
American Societyfor Microbiology’s ICAAC 2015 conference in September in San Diego.
Conference Call Information
There will be a conference call with management today at
The conference call will be available via phone and webcast. The dial-in information is listed below:
Domestic Dial In: + 1 (877) 359-9508
International Dial In: + 1 (224) 357-2393
Passcode for both dial-in numbers: 80816169
Replay is available from
This call is being webcast and can be accessed via The
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, share-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 remeasurement of equity
investment, gain on sale of 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 and six months 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.
Statements contained in this press release about The
|The Medicines Company|
|Consolidated Statements of Income|
|(in thousands, except per share data)||Three months ended June 30,||Six months ended June 30,|
|Cost of revenue||36,999||85,687||70,736||152,554|
|Research and development||36,221||41,228||60,170||72,324|
|Selling, general and administrative||96,246||88,745||176,780||153,266|
|Total operating expenses||169,466||215,660||307,686||378,144|
|Loss from operations||(78,994||)||(31,886||)||(90,698||)||(17,135||)|
|Co-promotion and license income||638||7,326||9,026||13,346|
|Gain on remeasurement of equity investment||—||—||22,741||—|
|Gain on sale of investment||19,773||—||19,773||—|
|Loss in equity investment||—||—||(144||)||—|
|Other (expense) income||94||(150||)||203||29|
|Loss before income taxes||(67,837||)||(28,602||)||(57,054||)||(11,512||)|
|Benefit for income taxes||21,298||23,428||15,521||1,333|
|Net loss (income) attributable to non-controlling interest||(53||)||17||(25||)||26|
|Net loss attributable to The Medicines Company||$||(46,592||)||$||(5,157||)||$||(41,558||)||$||(10,153||)|
|Loss per common share attributable to The Medicines Company:|
|Weighted average number of common shares outstanding:|
|Balance Sheet Items|
|(in thousands)||June 30,||December 31,|
|Cash and cash equivalents||$||462,743||$||370,741|
|Convertible senior notes (due 2017 and due 2022*)||$||568,044||$||246,676|
|The Medicines Company stockholders' equity||$||972,241||$||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 June 30,||Six months ended June 30,|
|(in thousands, except per share amounts)||2015||2014||2015||2014|
|Net loss attributable to The Medicines Company - GAAP||$||(46,592||)||$||(5,157||)||$||(41,558||)||$||(10,153||)|
|Before tax adjustments:|
|Cost of revenue:|
|Share-based compensation expense||(1)||227||120||423||202|
|Amortization of acquired intangible assets||(2)||9,584||21,526||15,994||26,616|
|Research and development:|
|Share-based compensation expense||(1)||1,133||1,480||2,064||2,813|
|Development milestone payments||(3)||5,352||8,429||5,352||8,429|
|Selling, general and administrative:|
|Share-based compensation expense||(1)||7,304||7,350||13,795||13,307|
|Amortization of acquired intangible assets||(2)||61||1,282||123||2,829|
|Change in contingent purchase price||(4)||11,826||17,353||13,246||19,617|
|Expenses incurred for certain transactions||(5)||—||566||—||566|
|Non-cash interest expense||(6)||5,920||2,948||11,436||5,862|
|Gain on sale of investment||(7)||(19,773||)||—||(19,773||)||—|
|Gain on remeasurement of equity investment||(8)||—||—||(22,741||)||—|
|Loss in equity investment||(9)||—||—||144||—|
|Net income tax adjustments||(10)||(17,794||)||(35,310||)||(15,581||)||(27,392||)|
|Net (loss) income attributable to The Medicines Company - Adjusted||$||(42,752||)||$||20,587||$||(37,076||)||$||42,696|
|Net (loss) income per share attributable to The Medicines Company - Adjusted|
|Weighted average number of common shares outstanding:|
|Diluted - Adjusted||(11)||65,903||66,061||65,541||66,358|
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 development milestone payments for manufacturing scale up for MDCO-216.
(4) Excludes changes in contingent purchase price due to shareholders of Targanta, Incline Therapeutics, ProFibrix, Rempex, Tenaxis and Annovation.
(5) Excludes charges related to the acquisition of Tenaxis.
(6) Excludes non-cash interest expense related to convertible senior notes.
(7) Excludes gain on sale of investment.
(8) Excludes gain on remeasurement of our equity investment in Annovation.
(9) Excludes loss in equity investment.
(10) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments.
(11) 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
Vice President, Communications