The Medicines Company Reports Third Quarter and First Nine Months 2014 Results
Nine Month Net Revenues Rise 6% year over year
Company Reports Progress with Product Candidates
Financial highlights for the third quarter of 2014:
Worldwide net revenue was
-
Worldwide Angiomax® (bivalirudin)/Angiox® (bivalirudin) revenue was
down 2% to
$151.0 million in 2014 compared to$153.6 million in 2013, sales inthe United States increased to$143.6 million in 2014 from$138.5 million in 2013. -
Recothrom® Thrombin topical (recombinant) sales were
$16.8 million in the US in the third quarter of 2014, as compared to$17.0 million in the third quarter of 2013. -
Other products including Argatroban RTU, Cleviprex® (clevidipine),
Minocin® (minocycline) for injection and PreveLeak recorded sales in
the third quarter of 2014 of
$4.6 million , as compared to$3.7 million in the third quarter of 2013.
Net loss for the third quarter of 2014 was
Adjusted net income(1) for the third quarter of 2014 was
Financial highlights for the nine months ended
Worldwide net revenue increased by 6% to
-
Worldwide Angiomax/Angiox revenue was up 5% to
$469.8 million in 2014 from$447.6 million in 2013, driven byUnited States growth (up to$442.0 million in 2014 from$407.8 million in 2013). -
Recothrom sales were
$46.5 million inthe United States in the first nine months of 2014. Sales during the first nine months of 2013 were$43.5 million , after the Company began selling Recothrom in the US inFebruary 2013 . -
Other products including Argatroban RTU, Cleviprex, Minocin and
PreveLeak recorded sales in the first nine months of 2014 of
$17.1 million , as compared to$11.7 million in the first nine months of 2013.
Net loss for the nine months ended
Adjusted net income(1) for the first nine months of 2014 was
Business, Research and Development Update
The company today announced the launch of ORBACTIVTM and
MINOCIN IV and an increase in selling resources for CLEVIPREX® in
The company also reports progress for KANGREAL, IONSYS, RAPLIXA and ORBACTIV which together constitute seven new drug applications under active review with either the United States FDA or the European EMA.
The company also reports the status of its research and development
programs. Clinical phase III development for Carbavance, an
investigational antibacterial agent for resistant gram negative
infections is underway and two potential registration trials are
expected to begin enrollment shortly. The company also reports progress
in its partnership with Alnylam developing a PCSK9 RNA interference
compound for lowering cholesterol which will shortly begin clinical
trials using subcutaneous dosing. In addition, the company reports that
new data will be presented for ApoA1-
“We are making considerable and rapid progress with launches, with our
ongoing NDA programs in US and
(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.
Conference Call Information
There will be a conference call with management today at
Domestic Dial In: +1 (877) 359-9508
International Dial In: +1 (224) 357-2393
Passcode for both dial in numbers: 18355946
Replay is available from
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,
development milestone payment, non-cash interest, one time impairment
charge, loss on equity 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 nine 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.
About The
The
Forward Looking Statements
Statements contained in this press release about The
The Medicines Company | ||||||||
Consolidated Statements of Income | ||||||||
(unaudited) | ||||||||
(in thousands, except per share data) | Three months ended September 30, | |||||||
2014 | 2013 | |||||||
Net revenue | $ | 172,401 | $ | 174,282 | ||||
Operating expenses: | ||||||||
Cost of revenue | 69,076 | 65,794 | ||||||
Research and development | 33,314 | 23,187 | ||||||
Selling, general and administrative | 82,662 | 62,528 | ||||||
Total operating expenses | 185,052 | 151,509 | ||||||
(Loss) income from operations | (12,651 | ) | 22,773 | |||||
Co-promotion income and profit share | 2,864 | 4,423 | ||||||
Loss in equity investment | (1,184 | ) |
- |
|||||
Interest expense | (3,958 | ) | (3,765 | ) | ||||
Investment impairment | (7,500 | ) |
- |
|||||
Other (expense) income | (53 | ) | 383 | |||||
(Loss) income before income taxes | (22,482 | ) | 23,814 | |||||
Benefit (provision) for income taxes | 5,693 | (16,068 | ) | |||||
Net (loss) income | (16,789 | ) | 7,746 | |||||
Net loss attributable to non-controlling interest | 53 | 47 | ||||||
Net (loss) income attributable to The Medicines Company | $ | (16,736 | ) | $ | 7,793 | |||
(Loss) earnings per common share attributable to The Medicines Company: | ||||||||
Basic | $ | (0.26 | ) | $ | 0.13 | |||
Diluted | $ | (0.26 | ) | $ | 0.12 | |||
Weighted average number of common shares outstanding: | ||||||||
Basic | 64,534 | 59,231 | ||||||
Diluted | 64,534 | 63,173 | ||||||
The Medicines Company | ||||||||
Consolidated Statements of Income | ||||||||
(unaudited) | ||||||||
(in thousands, except per share data) | Nine months ended September 30, | |||||||
2014 | 2013 | |||||||
Net revenue | $ | 533,410 | $ | 502,861 | ||||
Operating expenses: | ||||||||
Cost of revenue | 221,630 | 186,446 | ||||||
Research and development | 105,638 | 108,408 | ||||||
Selling, general and administrative | 235,928 | 178,954 | ||||||
Total operating expenses | 563,196 | 473,808 | ||||||
(Loss) income from operations | (29,786 | ) | 29,053 | |||||
Co-promotion income and profit share | 16,210 | 12,241 | ||||||
Loss in equity investment | (1,184 | ) |
- |
|||||
Interest expense | (11,710 | ) | (11,143 | ) | ||||
Investment impairment | (7,500 | ) |
- |
|||||
Other (expense) income | (24 | ) | 1,186 | |||||
(Loss) income before income taxes | (33,994 | ) | 31,337 | |||||
Benefit (provision) for income taxes | 7,026 | (17,163 | ) | |||||
Net (loss) income | (26,968 | ) | 14,174 | |||||
Net loss attributable to non-controlling interest | 79 | 140 | ||||||
Net (loss) income attributable to The Medicines Company | $ | (26,889 | ) | $ | 14,314 | |||
(Loss) earnings per common share attributable to The Medicines Company: | ||||||||
Basic | $ | (0.42 | ) | $ | 0.25 | |||
Diluted | $ | (0.42 | ) | $ | 0.24 | |||
Weighted average number of common shares outstanding: | ||||||||
Basic | 64,363 | 56,296 | ||||||
Diluted | 64,363 | 60,510 | ||||||
Balance Sheet Items | |||||||
(in thousands) | September 30, | December 31, | |||||
2014 | 2013 | ||||||
(unaudited) | |||||||
Cash and cash equivalents | $ | 356,239 | $ | 376,727 | |||
Total assets | $ | 1,829,384 | $ | 1,741,282 | |||
Convertible senior notes (due 2017) | $ | 243,976 | $ | 236,088 | |||
The Medicines Company total stockholders' equity | $ | 910,572 | $ | 892,161 | |||
The Medicines Company | ||||||||||||||||
Reconciliation of GAAP to Adjusted Net Income and Adjusted Earnings Per Share | ||||||||||||||||
(unaudited) | ||||||||||||||||
(in thousands, except per share data) | Three months ended | Nine months ended | ||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Net (loss) income attributable to The Medicines Company - GAAP | $ | (16,736 | ) | $ | 7,793 | $ | (26,889 | ) | $ | 14,314 | ||||||
Before tax adjustments: | ||||||||||||||||
Cost of revenue: | ||||||||||||||||
Share based compensation expense | (1) | 149 | 43 | 351 | 147 | |||||||||||
Amortization of acquired intangible assets | (6) | 6,236 | 5,076 | 32,852 | 13,894 | |||||||||||
Restructuring charges | (2) |
- |
- |
- |
581 | |||||||||||
Research and development: | ||||||||||||||||
Stock based compensation expense | (1) | 1,629 | 924 | 4,442 | 2,630 | |||||||||||
Restructuring charges | (2) |
- |
- |
- |
1,252 | |||||||||||
Upfront collaboration payments | (3) |
- |
- |
- |
25,000 | |||||||||||
One time license payment |
- |
- |
8,429 |
- |
||||||||||||
Selling, general and administrative: | ||||||||||||||||
Stock based compensation expense | (1) | 6,636 | 4,492 | 19,943 | 12,850 | |||||||||||
Amortization of acquired intangible assets | (6) | 1,414 | 1,136 | 4,243 | 3,408 | |||||||||||
Change in contingent value rights | (7) | 9,114 | 5,480 | 28,731 | (168 | ) | ||||||||||
Restructuring charges | (2) |
- |
- |
- |
4,525 | |||||||||||
Milestone Payment | (10) | 2,500 |
- |
2,500 |
- |
|||||||||||
Expenses incurred for certain transactions | (4) |
- |
2,907 | 566 | 7,076 | |||||||||||
Arbitration award | (5) |
- |
- |
- |
5,000 | |||||||||||
Other: | ||||||||||||||||
Non-cash interest expense | (8) | 3,012 | 2,820 | 8,874 | 8,307 | |||||||||||
Investment impairment | (11) | 7,500 |
- |
7,500 |
- |
|||||||||||
Loss in equity investment | (12) | 1,184 |
- |
1,184 |
- |
|||||||||||
Net income tax adjustments | (9) | (11,062 | ) | (1,381 | ) | (38,454 | ) | (22,319 | ) | |||||||
Net income attributable to The Medicines Company - Adjusted | $ | 11,576 | $ | 29,290 | $ | 54,272 | $ | 76,497 | ||||||||
Net income per share attributable to The Medicines Company - Adjusted | ||||||||||||||||
Basic | $ | 0.18 | $ | 0.49 | $ | 0.84 | $ | 1.36 | ||||||||
Diluted | (13) | $ | 0.18 | $ | 0.47 | $ | 0.82 | $ | 1.29 | |||||||
Weighted average number of common shares outstanding: | ||||||||||||||||
Basic | 64,534 | 59,231 | 64,363 | 56,296 | ||||||||||||
Diluted - adjusted | (13) | 66,067 | 61,960 | 66,262 | 59,271 | |||||||||||
Explanation of Adjustments:
(1) Exclude share based compensation of
(2) Exclude restructuring charges relating to headcount reduction of
(3) Exclude upfront payments for research and development collaboration arrangements.
(4) Exclude charges related to the acquisition of Incline, ProFibrix and license of Recothrom during 2013 and acquisition of Tenaxis during 2014.
(5) Exclude one time arbitration award to Eagle.
(6) Exclude amortization of intangible assets and other charges resulting from transactions with Nycomed, CSL, APP, Teva, BMS, Rempex and Tenaxis.
(7) Exclude changes in contingent value rights due to shareholders of Targanta, Incline, ProFibrix, Rempex and Tenaxis.
(8) Exclude non-cash interest expense related to convertible senior notes.
(9) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other
non-operating tax adjustments.
(10) Excludes milestone payment for product approval
(11) Excludes write off of impaired investment
(12) Excludes loss on equity
(13) Reflects impact of note hedge transactions on outstanding diluted share amounts associated with 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.
Source: The
The Medicines Company
Investor Relations, +1 973-290-6400
[email protected]
or
Media:
Robert
Laverty, +1 973-290-6162
Vice President Communications
[email protected]