- Inclisiran’s pivotal Phase 3 LDL-C lowering clinical trials
program successfully completed, and each study met all primary and
secondary endpoints
- Phase 3 data reinforced durable, potent efficacy and excellent
safety
- ORION-11 results presented at ESC Congress 2019
- ORION-9 and ORION-10 topline results announced, with detailed
data presentations to occur at the upcoming American Heart
Association Scientific Sessions 2019
- Validation of manufacturing batches completed
The Medicines Company (NASDAQ: MDCO) today reported financial
results for the third quarter that ended September 30, 2019.
Third-quarter highlights included successful completion of pivotal
Phase 3 LDL cholesterol (LDL-C) lowering clinical trials for
inclisiran with presentation of efficacy and safety data for
ORION-11 at the European Society of Cardiology’s ESC Congress 2019
and announcement of topline results for ORION-9 and ORION-10. Each
study met all primary and secondary endpoints, showing durable and
potent efficacy with twice-yearly dosing of inclisiran and
excellent safety with no treatment-related liver or renal
laboratory abnormalities.
“Flawless execution defined our performance in the third
quarter, as outstanding progress for our pivotal Phase 3 clinical
trials moves us closer to our goal of realizing the intrinsic value
of inclisiran,” said Mark Timney, Chief Executive Officer of The
Medicines Company. “Clinical data confirm inclisiran’s highly
differentiated profile and reinforce its potential to transform the
treatment of cardiovascular disease for millions of patients with
significant unmet needs.”
During the quarter, the company completed validation of
manufacturing batches for inclisiran, enabling commercial scale
manufacturing and also supporting anticipated regulatory
submissions in the U.S. in the fourth quarter of 2019 and in Europe
in the first quarter of 2020.
Clinical Development Highlights
The ORION program is studying the efficacy and safety of
inclisiran in patients with atherosclerotic cardiovascular disease
(ASCVD) and familial hypercholesterolemia (FH), with ORION-9,
ORION-10 and ORION-11 comprising the pivotal Phase 3 LDL-C lowering
studies.
The company presented results of the ORION-11 study of patients
with ASCVD or ASCVD-risk equivalents during a late-breaking science
session at the ESC Congress 2019 in Paris (click here). For the
primary endpoints of ORION-11, inclisiran delivered
placebo-adjusted LDL-C reductions of 54% (p<0.0001) at day 510
and demonstrated time-averaged placebo-adjusted LDL-C reductions of
50% (p<0.0001) from days 90 through 540.
The company announced topline results of the ORION-9 study
(click here) in heterozygous FH (HeFH) patients and the ORION-10
study (click here) in ASCVD patients. Data from ORION-10 will be
presented at the American Heart Association Scientific Sessions in
Philadelphia on Saturday, November 16, 11:06 am EST, during Late
Breaking Science I: Outside the Box: New Approaches to CVD Risk
Reduction. The company will present data from ORION-9 on Monday,
November 18, 9:24am EST, during Late Breaking Science VI: New
Frontiers in Lipid Therapy.
“Three Phase 3 study read-outs in quick succession and the
completion of manufacturing validation are exceptional
achievements,” said Peter Wijngaard, Ph.D., Chief Development
Officer of The Medicines Company. “These critical milestones allow
us to proceed toward planned regulatory filings as we
simultaneously prepare submission of manuscripts to peer-reviewed
medical journals for publication of ORION-9, -10 and -11 data.”
Patients who have completed their respective Phase 3 studies are
now enrolling into ORION-8, an open-label, long-term extension
study where patients completing ORION-9, ORION-10 and ORION-11 will
receive inclisiran for three years to evaluate the efficacy and
safety of long-term dosing of inclisiran.
Third-Quarter 2019 Financial Summary from Continuing
Operations
On a GAAP basis, loss from continuing operations in the third
quarter of 2019 was $74.0 million, or $0.92 per share, compared to
a loss of $51.6 million, or $0.70 per share, in the third quarter
of 2018. On a non-GAAP basis, adjusted loss1 from continuing
operations in the third quarter of 2019 was $58.1 million, or $0.72
1 per share, compared to a loss of $51.5 million, or $0.70 1 per
share, in the third quarter of 2018.
At September 30, 2019, the company had $265.9 million in cash
and cash equivalents, compared to $238.3 million at the end of
2018.
First Nine Months 2019 Financial Summary from Continuing
Operations
On a GAAP basis, loss from continuing operations in the first
nine months of 2019 was $193.9 million, or $2.55 per share,
compared to a loss of $190.9 million, or $2.60 per share, in the
first nine months of 2018. On a non-GAAP basis, adjusted loss 1
from continuing operations in the first nine months of 2019 was
$151.4 million, or $1.99 1 per share, compared to a loss of $154.2
million, or $2.10 1 per share, in the first nine months of
2018.
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 2019 Conference Call and Webcast
Information
The Company will host a conference call and webcast today,
October 30, 2019, at 8:30 a.m., EDT, to discuss its third-quarter
2019 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) 389-0899
Conference ID:
13696004
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:
13696004
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, the first and only cholesterol-lowering therapy in
the siRNA (small-interfering RNA) class, is The Medicines Company’s
investigational twice-yearly therapy in Phase 3 clinical
development to evaluate its ability to reduce low-density
lipoprotein cholesterol (also known as LDL-C). As a siRNA,
inclisiran harnesses the body’s natural process of RNA interference
to specifically prevent production of the PCSK9 protein in the
liver, which enhances the liver’s ability to remove LDL-C from the
bloodstream, thereby lowering LDL-C levels. Inclisiran is not yet
approved by the FDA or any other regulatory authority. The
Medicines Company obtained global rights to develop, manufacture
and commercialize inclisiran under a license and collaboration
agreement with Alnylam Pharmaceuticals.
Commercial Opportunity
Nearly 60 million people with ASCVD or FH across the U.S., the
largest European countries, China and Japan are currently treated
with lipid-lowering therapies to manage cardiovascular risk. More
than 70% of these patients are not achieving LDL-C treatment goals
with current therapies, and approximately two-thirds of patients do
not adhere to available first-line cholesterol-lowering treatments
after one year. This implies a population of more than 40 million
people who could potentially benefit from the investigational
candidate inclisiran in the aforementioned countries alone.
Inclisiran is the first cholesterol-lowering siRNA with the
potential to deliver potent and durable lowering of LDL-C levels
via twice-yearly dosing that can help address two critical unmet
needs – additional LDL-C lowering and poor adherence to
therapy.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is a biopharmaceutical
company with a singular, relentless focus on addressing the
greatest global healthcare challenge and burden today –
cardiovascular disease. Our purpose is to halt the deadly
progression of atherosclerosis and the cardiovascular risk created
by high levels of LDL-C, or bad cholesterol. The Company is
headquartered in Parsippany, New Jersey. For more information,
please visit www.themedicinescompany.com and follow us on Twitter
@MDCONews and LinkedIn.
Forward-Looking Statements
Statements contained in this press release that are not purely
historical, including, but not limited to, statements about the
Company, the proposed offering described herein and the use of
proceeds therefrom, are 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 SEC, including,
without limitation, the risk factors detailed in the Company's
Quarterly Report on Form 10-Q filed with the SEC on July 24, 2019.
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, 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, 2019 and 2018.
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 COMPANY
CONSOLIDATED STATEMENTS OF
OPERATIONS
UNAUDITED
(In thousands, except per share
amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Net revenues
$
—
$
(3,300)
$
—
$
6,138
Operating expenses:
Cost of revenues
—
890
—
6,558
Asset impairment charges
—
5,073
—
5,073
Research and development
42,770
32,736
97,893
103,396
Selling, general and administrative
18,599
6,826
55,470
56,790
Total operating expenses
61,369
45,525
153,363
171,817
Loss from operations
(61,369
)
(48,825
)
(153,363
)
(165,679
)
Co-promotion and license income
4,402
271
4,402
753
Loss on short-term investment
(1,893)
(7,953
)
(102)
(41,416
)
Interest expense
(16,212
)
(12,313
)
(48,027
)
(36,498
)
Other income
1,088
1,119
3,196
4,541
Loss from continuing operations before
income taxes
(73,984
)
(67,701
)
(193,894
)
(238,299
)
(Provision for) benefit from income
taxes
(10
)
16,066
(20
)
47,375
Loss from continuing operations
(73,994
)
(51,635
)
(193,914
)
(190,924
)
Income from discontinued operations, net
of tax
—
(3,999)
—
110,242
Net loss
$
(73,994
)
$
(55,634
)
$
(193,914
)
$
(80,682
)
Basic loss per common share:
Loss from continuing operations
$
(0.92
)
$
(0.70
)
$
(2.55
)
$
(2.60
)
Earnings from discontinued operations
—
(0.05)
—
1.50
Basic loss per share
$
(0.92
)
$
(0.75
)
$
(2.55
)
$
(1.10
)
Diluted loss per common share:
Loss from continuing operations
$
(0.92
)
$
(0.70
)
$
(2.55
)
$
(2.60
)
Earnings from discontinued operations
—
(0.05)
—
1.50
Diluted loss per share
$
(0.92
)
$
(0.75
)
$
(2.55
)
$
(1.10
)
Weighted average number of common shares
outstanding:
Basic
80,129
73,544
75,928
73,564
Diluted
80,129
73,544
75,928
73,564
THE MEDICINES COMPANY
BALANCE SHEET ITEMS
UNAUDITED
(In thousands)
September 30, 2019
December 31, 2018
Cash and cash equivalents
$
265,850
$
238,310
Short-term investment
$
2,525
$
2,627
Total assets
$
897,270
$
841,686
Convertible senior notes (due 2022, 2023
and 2024)
$
827,303
$
792,752
Stockholders' deficit
$
(59,540)
$
(22,264
)
THE MEDICINES COMPANY
RECONCILIATIONS OF GAAP TO
ADJUSTED LOSS FROM CONTINUING OPERATIONS AND ADJUSTED LOSS PER
SHARE
UNAUDITED
(In thousands, except per share
amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Loss from continuing operations
$
(73,994
)
$
(51,635
)
$
(193,914
)
$
(190,924
)
Before tax adjustments:
Cost of product revenues:
Share-based compensation expense
(1)
—
42
—
111
Inventory adjustments
(2)
—
—
—
(407
)
Restructuring charges
(3)
—
(196)
—
565
Asset impairment charges
Asset impairment
(4)
—
5,073
—
5,073
Research and development:
Share-based compensation expense
(1)
1,891
1,389
5,005
3,568
Restructuring charges
(3)
(12
)
(548
)
(105
)
3,100
Selling, general and administrative:
Share-based compensation expense
(1)
2,638
2,743
9,718
9,569
Restructuring charges
(3)
(12
)
137
4
7,132
Changes in contingent purchase price
(5)
—
—
—
(258
)
Gain on sale of assets
(6)
—
(7,025
)
—
(7,025
)
Legal settlements
(7)
—
—
—
3,550
Other:
Non-cash interest expense
(8)
9,549
6,995
27,762
20,526
Change in short-term investments
(9)
1,882
7,541
102
38,642
Net loss tax adjustments
(10)
—
(16,065
)
—
(47,407
)
Loss from continuing operations -
Adjusted
$
(58,058
)
$
(51,549
)
$
(151,428
)
$
(154,185
)
Loss from continuing operations per share
- Adjusted
Basic
$
(0.72
)
$
(0.70
)
$
(1.99
)
$
(2.10
)
Diluted
$
(0.72
)
$
(0.70
)
$
(1.99
)
$
(2.10
)
Weighted average number of common shares
outstanding:
Basic
80,129
73,544
75,928
73,564
Diluted
80,129
73,544
75,928
73,564
Explanation of Adjustments:
(1) Excludes share-based compensation of $4,529 and $4,174 for
the three months ended September 30, 2019 and 2018 and $14,723 and
$13,248 for the nine months ended September 30, 2019 and 2018
because these expenses are substantially dependent on changes in
the market price of the Company's common stock.
(2) Excludes all non-cash inventory adjustments.
(3) Excludes restructuring charges related to workforce
reorganization initiated in the first quarter 2018.
(4) Excludes non-cash asset impairment charges associated with
the early stage infectious disease products.
(5) Excludes changes in fair value of the contingent price
related to the acquisition of Rempex Pharmaceuticals, Inc. that
were not included in the sale to Melinta.
(6) Excludes gain from the sale of the Angiomax business.
(7) Excludes net loss from one-time legal settlements in
2018.
(8) Excludes non-cash interest expense, which is in excess of
the actual interest expense paid on the convertible senior
notes.
(9) Excludes changes in fair value of our investment in Melinta
net of guaranteed payment accretion associated with the sale of our
infectious disease business.
(10) Excludes the estimated non-cash income tax expense.
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/20191030005119/en/
Investor Relations Krishna Gorti, M.D. Investor Relations
+1 973 290 6122 krishna.gorti@themedco.com
Media Inquiries Michael Blash Communications +1 973 290
6100 michael.blash@themedco.com
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