The Medicines Company (NASDAQ:MDCO) today reported its financial
results for the third quarter ended September 30, 2018.
“During the third quarter of 2018, we continued to advance
inclisiran through Phase III trials and other, key development
steps,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer
of The Medicines Company. “We continue to be impressed by the
blinded safety data emerging from the Phase III trials, and expect
our clinical momentum to continue into 2019, moving toward
anticipated clinical data readout early in the second half of 2019,
as well as NDA and MAA submissions in late 2019 and early 2020,
respectively.”
Third quarter 2018 highlights and recent developments include
the following:
- In late September, the Independent Data
Monitoring Committee (IDMC) for the ongoing inclisiran Phase III
clinical trials conducted its fourth planned review of un-blinded
safety and efficacy data from the trials, and recommended that they
continue as designed and conducted, without modification. At the
time of the IDMC’s review, more than 1,899 patient years of safety
data had been accumulated, with substantially all randomized
patients having received two doses of inclisiran or placebo, and
more than 648 patients having received their third dose. To date,
more than 2,900 patients have received three of four planned doses
in the ORION-9, -10 and -11 Phase III trials, and more than 2,100
patient years of safety data for inclisiran have been
accumulated.
- In October, the Company, together with
Oxford University in the United Kingdom and the TIMI Study Group in
the United States, commenced the ORION-4 cardiovascular outcomes
trial to assess whether inclisiran, compared to placebo, reduces
recurrent major adverse cardiovascular events in approximately
15,000 patients with atherosclerotic cardiovascular disease
(ASCVD). ORION-4 is a double-blind, randomized, multinational trial
in subjects aged 55 years or older with pre-existing ASCVD at
approximately 150 clinical sites in the United Kingdom and the
United States. Trial participants will receive inclisiran sodium
300 mg or matching placebo (given by subcutaneous injection on
Day-1, at Day-90 and then every six months thereafter) in a 1:1
ratio for a planned median duration of 5 years, with a planned
interim analysis for efficacy occurring at a median follow-up of 4
years. The primary objective of the ORION-4 trial is to evaluate
the effect of inclisiran treatment on the incidence of
cardiovascular events in patients with high risk ASCVD and not at
their LDL-C goal. The primary endpoint is a composite of coronary
heart disease (CHD) death, Myocardial infarction (MI), fatal or
non-fatal ischemic stroke, and urgent coronary revascularization
procedures. The key secondary endpoints are cardiovascular
mortality and a composite of CHD death or MI. The trial will
include robust safety monitoring throughout its duration.
- In October, the Company received an
issue notification from the U.S. Patent and Trademark Office
indicating that the Company’s composition of matter patent for
inclisiran will be issued on November 13, 2018. This patent is
expected to be the principal U.S. patent covering inclisiran and,
when issued, will run through December 2033, with potential patent
term extension and pediatric exclusivity likely to further extend
market exclusivity.
Third-Quarter 2018 Financial Summary from Continuing
Operations
On a GAAP basis, loss from continuing operations in the third
quarter of 2018 was $51.6 million, or $0.70 per share, compared to
a loss of $7.2 million, or $0.10 per share, in the third
quarter of 2017. Included in loss from continuing operations for
the third quarter of 2018 was a non-cash, mark-to-market reduction
in fair value of approximately $8.0 million associated with the
Company’s common stock ownership in Melinta Therapeutics, Inc.
(Melinta); a $3.3 million charge related to changes in estimated
net sales reserves related to Angiomax chargebacks and returns as a
result of the accounting for the sale of the Company’s rights to
branded Angiomax in the United States to Sandoz Inc. (Sandoz); a
$5.1 million non-cash impairment charge related to fixed
assets associated with the early-stage infectious disease products;
partially offset by a $7.0 million gain from the sale of the
Company’s rights to branded Angiomax in the United States to
Sandoz. On a non-GAAP basis, adjusted loss(1) from continuing
operations in the third quarter of 2018 was $51.5 million, or
$0.70(1) per share, compared to a loss of $59.3 million, or
$0.82(1) per share, in the third quarter of 2017.
First Nine Months 2018 Financial Summary from Continuing
Operations
On a GAAP basis, loss from continuing operations in the first
nine months of 2018 was $190.9 million, or $2.60 per share,
compared to a loss of $448.3 million, or $6.25 per share, in the
first nine months of 2017. Included in loss from continuing
operations for the first nine months of 2018 was a non-cash,
mark-to-market reduction in fair value of approximately $41.4
million associated with the Company's common stock ownership in
Melinta; restructuring charges of $10.8 million; and a $5.1 million
non-cash impairment charge related to fixed assets associated with
the early-stage infectious disease products; partially offset by a
$7.0 million gain from the sale of the Company’s rights to branded
Angiomax in the United States to Sandoz. On a non-GAAP basis,
adjusted loss(1) from continuing operations in the first nine
months of 2018 was $154.2 million, or $2.10(1) per share, compared
to a loss of $164.6 million, or $2.29(1) per share, in the first
nine months of 2017.
First Nine Months 2018 Financial Summary from Discontinued
Operations
In the first quarter of 2018, the Company completed the sale of
its infectious disease business, consisting of the products
Vabomere™, Orbactiv® and Minocin® IV, as well as line extensions of
those products, for $270 million in upfront consideration
(including Melinta common stock) and guaranteed payments, tiered
royalty payments of 5% to 25% on worldwide net sales of Vabomere,
Orbactiv and Minocin IV, and the assumption by Melinta of all
royalty, milestone and other payment obligations relating to those
products.
Net income from discontinued operations in the first nine months
of 2018 was $110.2 million, compared to a net loss of $81.8 million
in the first nine months of 2017. Net income from discontinued
operations in the first nine months of 2018 included a pre-tax gain
of approximately $169.0 million from the sale of the Company's
infectious disease business to Melinta.
At September 30, 2018, the Company had $118.7 million in cash
and cash equivalents, compared to $151.4 million at the end of
2017.
(1) Adjusted net loss and adjusted loss per share from
continuing operations are non-GAAP financial performance measures
with no standardized definitions under U.S. GAAP. For further
information and a detailed reconciliation, refer to the “Non-GAAP
Financial Performance Measures” and “Reconciliations of GAAP to
Adjusted Loss From Continuing Operations and Adjusted Loss per
Share” sections of this press release.
Third-Quarter 2018 Conference Call and Webcast
Information
The Company will host a conference call and webcast today,
November 8, 2018, at 8:30 a.m., Eastern Standard Time, to discuss
its third-quarter 2018 financial results and provide clinical and
operational updates. The dial-in information to access the call is
as follows:
U.S./Canada: (877) 407-0312 International:
(201) 389-0905 Conference ID: 13684654
A taped replay of the conference call will be available after
the call concludes, and may be accessed by telephone as
follows:
U.S./Canada: (877) 660-6853 International:
(201) 612-7415 Conference ID: 13684654
A live audio webcast of the conference call may be accessed in
the “Investors” section of The Medicines Company website. An
archived webcast will be available after the call concludes.
About Inclisiran
Inclisiran is an investigational GalNAc-conjugated RNA
interference therapeutic, which inhibits the synthesis of PCSK9
protein in liver cells, thereby reducing liver cell LDL receptor
turnover, and lowering plasma LDL-C.
The Medicines Company and Alnylam Pharmaceuticals, Inc. are
collaborating in the advancement of inclisiran pursuant to their
2013 agreement. Under the terms of the agreement, Alnylam completed
certain pre-clinical studies and the Phase I clinical study, with
The Medicines Company leading and funding the development of
inclisiran from Phase II forward, as well as potential
commercialization.
About The Medicines Company
The Medicines Company is a biopharmaceutical company driven by
an overriding purpose – to save lives, alleviate suffering and
contribute to the economics of healthcare. The Company’s goal is to
create transformational solutions to address the most pressing
healthcare needs facing patients, physicians and providers in
cardiovascular care. The Company is headquartered in Parsippany,
New Jersey.
Forward-Looking Statements
Statements contained in this press release about The Medicines
Company that are not purely historical, and all other statements
that are not purely historical, may be deemed to be forward-looking
statements for purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995. Without limiting
the foregoing, the words “believes," “anticipates,” “plans,”
“expects,” “should,” and “potential,” and similar expressions, are
intended to identify forward-looking statements. These
forward-looking statements involve known and unknown risks and
uncertainties that may cause the Company's actual results, levels
of activity, performance or achievements to be materially different
from those expressed or implied by these forward-looking
statements. Important factors that may cause or contribute to such
differences include the ability of the Company to effectively
develop inclisiran; whether inclisiran will advance in the clinical
trials process on a timely basis or at all, or succeed in achieving
its specified endpoints; whether the Company will make regulatory
submissions for inclisiran on a timely basis; whether its
regulatory submissions will receive approvals from regulatory
agencies on a timely basis or at all; the extent of the commercial
success of inclisiran, if approved; the strength, durability and
life of the Company’s patent protection for inclisiran and whether
the Company will be successful in extending exclusivity; and such
other factors as are set forth in the risk factors detailed from
time to time in the Company's periodic reports and registration
statements filed with the Securities and Exchange Commission (SEC),
including, without limitation, the risk factors detailed in the
Company's Quarterly Report on Form 10-Q filed with the SEC on
August 2, 2018, which are incorporated herein by reference. The
Company specifically disclaims any obligation to update these
forward-looking statements.
NON-GAAP FINANCIAL PERFORMANCE MEASURES
In addition to financial information prepared in accordance with
U.S. GAAP, this press release also contains adjusted loss from
continuing operations and adjusted loss per share from continuing
operations attributable to The Medicines Company. The Company
believes these measures 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 loss from continuing operations excludes share-based
compensation expense, amortization of acquired intangible assets,
asset impairment charges, inventory adjustments, restructuring
charges, charges and gains associated with product discontinuance,
changes in contingent purchase price, legal settlements, changes in
short-term investments and non-cash interest expense. The Company
believes these non-GAAP financial measures help indicate underlying
trends in the Company’s business and are important in comparing
current results with prior period results and understanding
projected operating performance. Non-GAAP financial measures
provide the Company and its investors with an indication of the
Company’s baseline performance before items that are considered by
the Company not to be reflective of the Company’s ongoing results.
See the attached “Reconciliations of GAAP to Adjusted Loss from
Continuing Operations and Adjusted Loss per Share” for explanations
of the amounts excluded and included to arrive at adjusted net loss
and adjusted loss per share amounts for the three- and nine-months
ended September 30, 2018 and 2017.
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. The Company strongly encourages
investors to review its consolidated financial statements and
publicly-filed reports in their entirety and cautions investors
that the non-GAAP measures used by the Company may differ from
similar measures used by other companies, even when similar terms
are used to identify such measures.
THE MEDICINES COMPANYCONSOLIDATED
STATEMENTS OF OPERATIONSUNAUDITED(In thousands, except
per share amounts)
Three Months
EndedSeptember 30, Nine Months EndedSeptember
30, 2018 2017 2018
2017 Net revenues $ (3,300 ) $ 7,868 $
6,138 $ 36,194 Operating expenses: Cost of revenues 890 4,287 6,558
26,755 Asset impairment charges 5,073 — 5,073 329,097 Research and
development 32,736 33,077 103,396 82,770 Selling, general and
administrative 6,826 33,765 56,790 102,581
Total operating expenses 45,525 71,129 171,817
541,203 Loss from operations (48,825 ) (63,261 )
(165,679 ) (505,009 ) Co-promotion and license income 271 769 753
2,283 Loss on short-term investment (7,953 ) — (41,416 ) — Interest
expense (12,313 ) (11,810 ) (36,498 ) (36,753 ) Other income 1,119
448 4,541 1,592 Loss from continuing
operations before income taxes (67,701 ) (73,854 ) (238,299 )
(537,887 ) Benefit (provision) for income taxes 16,066
66,636 47,375 89,608 Loss from continuing
operations (51,635 ) (7,218 ) (190,924 ) (448,279 ) (Loss) income
from discontinued operations, net of tax (3,999 ) (22,957 ) 110,242
(81,834 ) Net Loss $ (55,634 ) $ (30,175 ) $ (80,682 ) $
(530,113 ) Basic (loss) earnings per common share: Loss from
continuing operations $ (0.70 ) $ (0.10 ) $ (2.60 ) $ (6.25 )
(Loss) earnings from discontinued operations (0.05 ) (0.32 ) 1.50
(1.14 ) Basic loss per share $ (0.75 ) $ (0.42 ) $ (1.10 ) $
(7.39 ) Diluted (loss) earnings per common share: Loss from
continuing operations $ (0.70 ) $ (0.10 ) $ (2.60 ) $ (6.25 )
(Loss) earnings from discontinued operations (0.05 ) (0.32 ) 1.50
(1.14 ) Diluted loss per share $ (0.75 ) $ (0.42 ) $ (1.10 )
$ (7.39 ) Weighted average number of common shares
outstanding: Basic 73,544 72,286 73,564 71,763 Diluted 73,544
72,286 73,564 71,763
THE MEDICINES COMPANYBALANCE SHEET
ITEMSUNAUDITED(In thousands)
September 30, 2018 December 31, 2017 Cash and cash
equivalents $ 118,708 $ 151,359 Short-term investment $ 13,089 $ —
Total assets $ 733,737 $ 872,983 Convertible senior notes (due 2022
and 2023) $ 669,724 $ 649,198 The Medicines Company stockholders'
(deficit) equity $ (26,564 ) $ 24,914
THE MEDICINES COMPANYRECONCILIATIONS
OF GAAP TO ADJUSTED LOSS FROM CONTINUING OPERATIONS AND ADJUSTED
LOSS PER SHAREUNAUDITED(In thousands, except per share
amounts)
Three Months
EndedSeptember 30, Nine Months EndedSeptember
30, 2018 2017 2018
2017 Loss from continuing operations $
(51,635 ) $ (7,218 ) $ (190,924 ) $ (448,279 ) Before tax
adjustments: Cost of product revenues: Share-based compensation
expense (1) 42 206 111 613 Amortization of acquired intangible
assets (2) — — — 4,486 Inventory adjustments (3) — (348 ) (407 )
(3,313 ) Restructuring charges (4) (196 ) 18 565 (48 ) Market
withdrawal of Ionsys (5) — — — 8,458 Asset impairment charges Asset
Impairment (6) 5,073 — 5,073 — Market withdrawal of Ionsys (5) — —
— 264,097 Discontinuance of MDCO 700 (7) — — — 65,000 Research and
development: Share-based compensation expense (1) 1,389 824 3,568
2,350 Restructuring charges (4) (548 ) (36 ) 3,100 360 Market
withdrawal of Ionsys (5) — — — 1,032 Selling, general and
administrative: Share-based compensation expense (1) 2,743 6,337
9,569 19,554 Restructuring charges (4) 137 1,110 7,132 1,006
Changes in contingent purchase price (8) — — (258 ) 692 Gain on
sale of assets (9) (7,025 ) — (7,025 ) — Legal settlements (10) — —
3,550 — Market withdrawal of Ionsys (5) — — — 3,434 Discontinuance
of MDCO 700 (7) — — — (14,701 ) Other: Non-cash interest expense
(11) 6,995 6,504 20,526 20,326 Change in short-term investments
(12) 7,541 — 38,642 — Net loss tax adjustments (13) (16,065 )
(66,713 ) (47,407 ) (89,702 ) Loss from continuing operations -
Adjusted $ (51,549 ) $ (59,316 ) $ (154,185 ) $ (164,635 )
Loss per share - Adjusted Basic $ (0.70 ) $ (0.82 ) $ (2.10 ) $
(2.29 ) Diluted $ (0.70 ) $ (0.82 ) $ (2.10 ) $ (2.29 ) Weighted
average number of common shares outstanding: Basic 73,544 72,286
73,564 71,763 Diluted 73,544 72,286 73,564 71,763
Explanation of Adjustments:
(1) Excludes share-based compensation of $4,174 and $7,367 for
the three months ended September 30, 2018 and 2017 and $13,248 and
$22,517 for the nine months ended September 30, 2018 and 2017
because these expenses are substantially dependent on changes in
the market price of the Company's common stock.
(2) Excludes amortization of intangible assets resulting from
the Incline Therapeutics transaction.
(3) Excludes all non-cash inventory adjustments.
(4) Excludes restructuring charges related to workforce
reorganization initiated in the first quarter 2018 and the sale of
the non-core cardiovascular products.
(5) Excludes charges associated with the voluntary
discontinuation and withdrawal of Ionsys from the market in the
United States and cessation of related commercial activities in
2017.
(6) Excludes non-cash asset impairment charges associated with
the early stage infectious disease products.
(7) Excludes costs associated with the decision to discontinue
the MDCO-700 program.
(8) Excludes changes in fair value of the contingent price
related to the acquisitions of Rempex that were not included in the
sale to Melinta.
(9) Excludes gain from the sale of the Angiomax business.
(10) Excludes net loss from one-time legal settlements in
2018.
(11) Excludes non-cash interest expense which is in excess of
the actual interest expense paid on the Convertible Senior
Notes.
(12) Excludes changes in fair value with our investment in
Melinta net of guaranteed payment accretion associated with the
sale of our infectious disease business.
(13) Excludes the estimated non-cash tax effect related to
adjustments above.
In addition to the financial information prepared in accordance
with U.S. GAAP, this press release also contains adjusted financial
measures that the Company believes 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. The Company
strongly encourages investors to review its consolidated financial
statements and publicly filed reports in their entirety and
cautions investors that the non-GAAP measures used by the Company
may differ from similar measures used by other companies, even when
similar terms are used to identify such measures.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181108005288/en/
Investor RelationsKrishna
Gorti, M.D.Vice President, Investor Relations(973)
290-6122krishna.gorti@themedco.com
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From Apr 2024 to May 2024
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From May 2023 to May 2024