NASDAQ: CRME TSX: COM
Management to Host Conference Call and Webcast
Today,
November 14, 2017 at 4:30 p.m. ET (1:30 p.m.
PT)
VANCOUVER, Nov. 14, 2017 /PRNewswire/ - Cardiome Pharma
Corp. (NASDAQ: CRME / TSX: COM), a revenue-generating, specialty
pharmaceutical company focused on commercializing patent-protected
hospital drugs, today reported financial results for the third
quarter ended September 30, 2017 and
commented on recent accomplishments and plans.
"We are extremely positive about strategic developments to date
in 2017, especially the recent licensing transaction with Basilea
which brought in Zevtera®/Mabelio®, a
high-value asset with rapid bactericidal activity against a wide
range of Gram-positive and Gram-negative bacteria, and a
complementary fit alongside Xydalba™," commented William Hunter, MD, CEO and President of
Cardiome. "Looking ahead to the remainder of the year, we
will continue to work diligently to lay the regulatory and
commercial groundwork for these high-value products, which we
expect will have increasingly positive impact during the remainder
of this year and into 2018, in which we are targeting meaningful
year over year revenue growth."
Third Quarter 2017 and Recent Highlights
- Cardiome signed a distribution and license agreement with
Basilea for the antibiotic Zevtera®/Mabelio®
(ceftobiprole medocaril sodium) a cephalosporin antibiotic for the
treatment of community- and hospital-acquired pneumonia in 34
European countries and Israel.
- Cardiome announced the commercial launch of Xydalba™
(dalbavancin hydrochloride) in Sweden, Finland and the Republic of Ireland, and has commenced
marketing the drug to hospitals in these countries. Xydalba is
approved by the European Medicines Agency (EMA) for the treatment
of Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in
adults.
- Cardiome received approval from Health Canada for the
Aggrastat® (tirofiban hydrochloride) high dose bolus
(HDB) regimen, better aligning the Canadian, United States, and European product
labels.
- Clinical data highlighting the clinical benefit of
Brinavess® was presented at the European Society of
Cardiology Congress (ESC) 2017. The retrospective data analysis
showed that administration of Brinavess® led to faster
restoration of sinus rhythm and shorter hospital stays when
compared to the same results for electrical cardioversion ("ECV").
While ECV was more effective in the cardioversion of recent onset
AF (94.0% vs. 66.5% respectively), longer-term there was
statistically significant reduction in AF recurrence in patients
treated with Brinavess® relative to ECV after 365
days.
- Trevyent licensor SteadyMed held an in-person Type A meeting
with the FDA on November 1, 2017,
following a RTF letter received in August
2017. SteadyMed believes the meeting was collaborative and
constructive and has agreed to a path forward with FDA that it
expects will allow for the resubmission and acceptance of
SteadyMed's Trevyent U.S. NDA. SteadyMed has stated its intention
to provide further details and guidance when meeting minutes are
received from the FDA in the near future.
Summary Results
Amounts, unless specified otherwise, are expressed in U.S.
dollars and in accordance with generally accepted accounting
principles used in the United States of
America (U.S. GAAP).
Cardiome recorded a net loss of $6.6
million (basic loss per share of $0.20) for the three months ended September 30, 2017 compared to a net loss of
$5.3 million (basic loss per share of
$0.19) for the three months ended
September 30, 2016. On a
year-to-date basis, Cardiome recorded a net loss of $21.5 million (basic loss per share of
$0.66) for the nine months ended
September 30, 2017 compared to a net
loss of $14.0 million (basic loss per
share of $0.61) for the nine months
ended September 30, 2016. The
increase in net loss on a year-to-date basis was due primarily to
an increase in selling, general and administration ("SG&A")
expense and a decrease in revenue.
Revenue for the three months ended September 30, 2017 was $6.0 million, a year-over-year increase of 15.0%,
compared to revenue of $5.2 million
for the three months ended September 30,
2016. The increase in revenue for the third quarter
was primarily attributable to the global commercial rollout of
Xydalba™ and higher sales of Aggrastat® in the Middle
East. Revenue for the nine months ended September 30, 2017 and 2016 was $17.0 million and $18.2
million, respectively. The decrease in revenue for the
nine months ended September 30, 2017
was due to the timing of distributor sales.
Gross margin for the three and nine months ended September 30, 2017 was 75.3% and 71.5%,
respectively, compared to 74.4% and 75.6% for the three and nine
months ended September 30, 2016.
The fluctuation in gross margin is primarily due to changes
in customer and product mix.
SG&A expense for the three months ended September 30, 2017 was $8.5 million compared to $7.2 million for the three months ended
September 30, 2016. The
increase in SG&A expense was primarily due to expansion of
Cardiome's direct sales force in Europe related to the launch of Xydalba™ and
to the initiation of a Canadian sales force. On a
year-to-date basis, SG&A expense for the nine months ended
September 30, 2017 was $26.3 million compared to $21.4 million for the nine months ended
September 30, 2016. The
increase in SG&A expense was due to the same factors as the
quarterly change. Additionally, there was an increase of
$1.7 million to the Company's
stock-based compensation expense as the Company had a stock-based
compensation recovery during the nine months ended September 30, 2016.
In the second quarter of 2017, the Company amended the terms of
its term loan agreement with CRG-managed funds. As a result,
Cardiome incurred investment banking, legal and other expenses of
$1.5 million during the nine months
ended September 30, 2017.
Interest expense was $1.8 million
for the three months ended September 30,
2017 compared to $0.9 million
for the three months ended September 30,
2016. The increase was due to an increase in long-term
debt in the third quarter of 2017 as the Company drew a third
tranche of $10.0 million under the
CRG term loan agreement. On a year-to-date basis, interest
expense for the nine months ended September
30, 2017 was $3.8 million
compared to $1.7 million for the nine
months ended September 30,
2016. The increase was due to interest being accrued on a
higher long-term debt principal amount during the nine months ended
September 30, 2017. Additionally, in
the second quarter of 2017, the Company began amortizing the
discount on the amended CRG term loan agreement in connection with
the warrants issued. This discount is being amortized to interest
expense.
Liquidity and Outstanding Share Capital
At September 30, 2017, the Company
had cash and cash equivalents of $27.2
million. As of November 13,
2017, there were 34,628,842 common shares issued and
outstanding, and 2,900,057 common shares issuable upon the exercise
of outstanding stock options (of which 1,762,582 were exercisable)
at a weighted average exercise price of CAD $5.51 per share, and 103,801 restricted share
units outstanding.
Financial Outlook
- Cardiome expects its 2017 revenues to be in the range of
$24-26 million.
- Cardiome repaid the remaining deferred consideration balance in
full in connection with the November
2013 acquisition of Correvio LLC.
- Based on its current operating plans, Cardiome expects that its
existing cash and cash equivalents will be sufficient to fund its
operations for at least the next 12 months.
- There are no share price or market capitalization covenants
relating to the Company's term loan agreement with CRG-managed
funds.
Conference Call
Cardiome will hold a conference call and webcast on Tuesday, November 14, 2017 at 4:30pm ET (1:30pm
PT). To access the conference call, please dial
416-764-8688 or 888-390-0546 and use conference ID 66802456. The
webcast can be accessed through Cardiome's website at
www.cardiome.com or through the following link:
https://event.on24.com/wcc/r/1532852/0B1B089E794F8F2B4346C40360FC4807
Webcast and telephone replays of the conference call will be
available approximately two hours after the completion of the call
through December 12, 2017.
Please dial 416-764-8677 or 888-390-0541 and enter code
802456 # to access the replay.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a revenue-generating, specialty
pharmaceutical company focused on providing innovative,
high-quality brands that meet the needs of acute care physicians
and patients. With a commercial presence and distribution
network covering over 60 countries worldwide, Cardiome develops,
acquires and commercializes brands for the in-hospital, acute care
market segment. The Company's portfolio of approved and
marketed brands includes: Xydalba™ (dalbavancin hydrochloride), for
the treatment of acute bacterial skin and skin structure infections
(ABSSSI); Zevtera®/Mabelio® (ceftobiprole
medocaril sodium), a cephalosporin antibiotic for the treatment of
community- and hospital-acquired pneumonia (CAP, HAP);
Brinavess® (vernakalant IV) for the rapid conversion of
recent onset atrial fibrillation to sinus rhythm;
Aggrastat® (tirofiban hydrochloride) for the reduction
of thrombotic cardiovascular events in patients with acute coronary
syndrome, and Esmocard® and Esmocard Lyo®
(esmolol hydrochloride), a short-acting beta-blocker used to
control rapid heart rate in a number of cardiovascular
indications. Cardiome's pipeline of product candidates
includes Trevyent®, a drug device combination that is
designed to deliver Remodulin® (treprostinil) the
world's leading treatment for pulmonary arterial hypertension.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the
Toronto Stock Exchange (COM). For more information, please visit
our web site at www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain
statements in this news release contain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 or forward-looking information under applicable Canadian
securities legislation that may not be based on historical fact,
including without limitation statements containing the words
"believe", "may", "plan", "will", "estimate", "continue",
"anticipate", "intend", "expect" and similar expressions. Forward-
looking statements may involve, but are not limited to, comments
with respect to our objectives and priorities for 2017 and beyond,
our strategies or future actions, our targets, expectations for our
financial condition and the results of, or outlook for, our
operations, research and development and product and drug
development. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause the
actual results, events or developments to be materially different
from any future results, events or developments expressed or
implied by such forward-looking statements. Many such known risks,
uncertainties and other factors are taken into account as part of
our assumptions underlying these forward-looking statements and
include, among others, the following: general economic and business
conditions in the United States,
Canada, Europe, and the other regions in which we
operate; market demand; technological changes that could impact our
existing products or our ability to develop and commercialize
future products; competition; existing governmental legislation and
regulations and changes in, or the failure to comply with,
governmental legislation and regulations; availability of financial
reimbursement coverage from governmental and third-party payers for
products and related treatments; adverse results or unexpected
delays in pre-clinical and clinical product development processes;
adverse findings related to the safety and/or efficacy of our
products or products; decisions, and the timing of decisions, made
by health regulatory agencies regarding approval of our technology
and products; the requirement for substantial funding to expand
commercialization activities; and any other factors that may affect
our performance. In addition, our business is subject to certain
operating risks that may cause any results expressed or implied by
the forward-looking statements in this presentation to differ
materially from our actual results. These operating risks include:
our ability to attract and retain qualified personnel; our ability
to successfully complete pre-clinical and clinical development of
our products; changes in our business strategy or development
plans; intellectual property matters, including the
unenforceability or loss of patent protection resulting from
third-party challenges to our patents; market acceptance of our
technology and products; our ability to successfully manufacture,
market and sell our products; and the availability of capital to
finance our activities;These and other risks are described in the
Form 40F and associated documents filed March 29, 2017 (see for example, "Risk Factors"
in the Annual Information Form for the year ended December 31, 2016), in the Form 6-K filed
August 10, 2017, and in our other
filings with the Securities and Exchange Commission ("SEC")
available at www.sec.gov and the Canadian securities regulatory
authorities at www.sedar.com. Given these risks,
uncertainties and factors, you are cautioned not to place undue
reliance on such forward-looking statements and information, which
are qualified in their entirety by this cautionary statement. All
forward-looking statements and information made herein are based on
our current expectations and we undertake no obligation to revise
or update such forward-looking statements and information to
reflect subsequent events or circumstances, except as required by
law.
Cardiome® and the Cardiome Logo are the proprietary
trademarks of Cardiome Pharma Corp.
Aggrastat® and Brinavess® are trademarks
owned by Cardiome and its affiliates worldwide.
Xydalba® is a trademark of Durata Therapeutics Holding
C.V., and used under license.
Zevtera® and Mabelio® are trademarks owned by
Basilea Pharmaceutica International Ltd., and used under
license.
Esmocard® and Esmocard Lyo® are trademarks
owned by Orpha-Devel Handels und Vertriebs GmbH, and used under
license.
Trevyent® is a trademark of SteadyMed and used under
license.
All other trademarks are the property of their respective
owners.
CARDIOME PHARMA CORP.
Interim Consolidated Balance
Sheets
(Expressed in thousands of U.S. dollars, except share amounts)
|
September
30,
2017
|
December 31,
2016
|
|
|
|
Assets
|
|
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
27,182
|
$
|
26,758
|
|
Restricted
cash
|
1,943
|
2,547
|
|
Accounts receivable,
net of allowance for doubtful accounts of $114 (2016 -
$97)
|
6,262
|
6,154
|
|
Inventories
|
6,294
|
4,618
|
|
Prepaid expenses and
other assets
|
1,525
|
1,302
|
|
43,206
|
41,379
|
|
|
|
Property and
equipment
|
451
|
548
|
Intangible
assets
|
28,445
|
24,352
|
Goodwill
|
318
|
318
|
Deferred income tax
assets
|
462
|
460
|
|
$
|
72,882
|
$
|
67,057
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
7,629
|
$
|
8,021
|
|
Current portion of
deferred consideration
|
-
|
2,815
|
|
Current portion of
deferred revenue
|
204
|
182
|
|
7,833
|
11,018
|
|
|
|
Long-term debt, net
of unamortized debt issuance costs and discount
|
39,014
|
19,391
|
Deferred
revenue
|
2,514
|
2,381
|
Other long-term
liabilities
|
220
|
243
|
|
49,581
|
33,033
|
|
|
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
352,711
|
344,928
|
|
|
Authorized -
unlimited number without par value
|
|
|
|
|
Issued and
outstanding – 33,940,715 (2016 – 31,884,420)
|
|
|
|
Additional paid-in
capital
|
38,074
|
35,812
|
|
Deficit
|
(384,522)
|
(363,054)
|
|
Accumulated other
comprehensive income
|
17,038
|
16,338
|
|
23,301
|
34,024
|
|
$
|
72,882
|
$
|
67,057
|
CARDIOME PHARMA CORP.
Interim Consolidated Statements
of Operations and Comprehensive Loss
(Unaudited)
(Expressed in thousands of U.S. dollars, except share and per share
amounts)
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
Nine months
ended
|
|
|
September
30, 2017
|
September
30, 2016
|
September
30, 2017
|
September
30, 2016
|
Revenue:
|
|
|
|
|
|
|
Product and royalty
revenues
|
|
$
|
5,970
|
$
|
5,186
|
$
|
16,828
|
$
|
18,093
|
|
Licensing and other
fees
|
|
51
|
51
|
146
|
145
|
|
|
6,021
|
5,237
|
16,974
|
18,238
|
Cost of goods
sold
|
|
1,488
|
1,342
|
4,845
|
4,452
|
Gross
margin
|
|
4,533
|
3,895
|
12,129
|
13,786
|
Expenses:
|
|
|
|
|
|
|
Selling, general and
administration
|
|
8,481
|
7,170
|
26,277
|
21,415
|
|
Amortization
|
|
890
|
853
|
2,567
|
2,131
|
|
|
9,371
|
8,023
|
28,844
|
23,546
|
Operating
loss
|
|
(4,838)
|
(4,128)
|
(16,715)
|
(9,760)
|
|
|
|
|
|
|
Other
expense:
|
|
|
|
|
|
|
Loss on
extinguishment of long-term debt
|
|
-
|
-
|
-
|
1,402
|
|
Other expense on
modification of long-term debt
|
|
29
|
-
|
1,451
|
-
|
|
Interest
expense
|
|
1,762
|
865
|
3,796
|
1,715
|
|
Other expense
(income)
|
|
175
|
(6)
|
282
|
329
|
|
Foreign exchange loss
(gain)
|
|
(255)
|
209
|
(881)
|
601
|
|
|
1,711
|
1,068
|
4,648
|
4,047
|
Loss before income
taxes
|
|
(6,549)
|
(5,196)
|
(21,363)
|
(13,807)
|
Income tax
expense
|
|
74
|
88
|
105
|
225
|
Net loss
|
|
$
|
(6,623)
|
$
|
(5,284)
|
$
|
(21,468)
|
$
|
(14,032)
|
Other comprehensive
loss:
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
|
173
|
149
|
700
|
515
|
Comprehensive
loss
|
|
$
|
(6,450)
|
$
|
(5,135)
|
$
|
(20,768)
|
$
|
(13,517)
|
Loss per common
share
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.20)
|
$
|
(0.19)
|
$
|
(0.66)
|
$
|
(0.61)
|
|
Diluted
|
|
$
|
(0.20)
|
$
|
(0.19)
|
$
|
(0.66)
|
$
|
(0.62)
|
Weighted average
common shares outstanding
|
|
|
|
|
|
|
Basic
|
|
33,835,677
|
28,376,143
|
32,730,558
|
23,034,503
|
|
Diluted
|
|
33,878,190
|
28,433,016
|
32,772,179
|
23,101,263
|
CARDIOME PHARMA CORP.
Interim Consolidated Statements
of Cash Flows
(Unaudited)
(Expressed in thousands of U.S. dollars)
|
|
|
|
|
|
|
Three months
ended
|
Nine months
ended
|
|
September
30, 2017
|
September
30, 2016
|
September 30,
2017
|
September 30,
2016
|
Operating
activities:
|
|
|
|
|
Net
loss
|
$
|
(6,623)
|
$
|
(5,284)
|
$
|
(21,468)
|
$
|
(14,032)
|
Items not affecting
cash:
|
|
|
|
|
|
Amortization
|
890
|
853
|
2,567
|
2,131
|
|
Accretion of
long-term debt
|
567
|
56
|
970
|
202
|
|
Interest paid in-kind
on long-term debt
|
366
|
-
|
366
|
-
|
|
Write-down of
inventory
|
163
|
-
|
233
|
-
|
|
Loss on
extinguishment of long-term debt
|
-
|
-
|
-
|
1,402
|
|
Stock-based
compensation expense (recovery)
|
311
|
209
|
1,641
|
(84)
|
|
Unrealized foreign
exchange gain (loss)
|
(445)
|
122
|
(1,417)
|
475
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
Restricted
cash
|
1,006
|
-
|
812
|
(295)
|
|
Accounts
receivable
|
(703)
|
2,435
|
473
|
1,923
|
|
Inventories
|
70
|
(87)
|
(1,412)
|
(116)
|
|
Prepaid expenses and
other assets
|
(305)
|
180
|
(203)
|
(323)
|
|
Accounts payable and
accrued liabilities
|
492
|
(2,900)
|
(767)
|
(2,441)
|
|
Deferred
revenue
|
(51)
|
21
|
(146)
|
(73)
|
|
Other long-term
liabilities
|
(8)
|
(8)
|
(23)
|
(23)
|
Net cash used in
operating activities
|
(4,270)
|
(4,403)
|
(18,374)
|
(11,254)
|
|
|
|
|
|
Investing
activities:
|
|
|
|
|
|
Purchase of property
and equipment
|
-
|
-
|
(5)
|
(9)
|
|
Purchase of
intangible assets
|
(5,206)
|
(8,017)
|
(5,219)
|
(13,628)
|
Net cash used in
investing activities
|
(5,206)
|
(8,017)
|
(5,224)
|
(13,637)
|
|
|
|
|
|
Financing
activities:
|
|
|
|
|
|
Issuance of common
stock
|
237
|
34,500
|
7,127
|
35,341
|
|
Share issue
costs
|
(10)
|
(2,722)
|
(352)
|
(2,752)
|
|
Issuance of common
stock upon exercise of stock options
|
-
|
-
|
384
|
-
|
|
Income tax
withholdings on vesting of restricted share units
|
(9)
|
(5)
|
(58)
|
(136)
|
|
Proceeds from
issuance of long-term debt
|
10,000
|
-
|
20,000
|
20,000
|
|
Financing fees on
issuance of long-term debt
|
(368)
|
(23)
|
(518)
|
(713)
|
|
Repayment of
long-term debt
|
-
|
-
|
-
|
(10,000)
|
|
Payment of fees on
extinguishment of long-term debt
|
-
|
-
|
-
|
(1,146)
|
|
Payment of deferred
consideration
|
(1,670)
|
(726)
|
(2,815)
|
(1,755)
|
Net cash provided by
financing activities
|
8,180
|
31,024
|
23,768
|
38,839
|
|
|
|
|
|
Increase (decrease)
in cash and cash equivalents during the period
|
(1,296)
|
18,604
|
170
|
13,948
|
Effect of foreign
exchange rate changes on cash and cash equivalents
|
95
|
46
|
254
|
(75)
|
Cash and cash
equivalents, beginning of period
|
28,383
|
12,884
|
26,758
|
17,661
|
Cash and cash
equivalents, end of period
|
$
|
27,182
|
$
|
31,534
|
$
|
27,182
|
$
|
31,534
|
|
|
|
|
|
Supplemental cash
flow information:
|
|
|
|
|
Interest
paid
|
$
|
843
|
$
|
815
|
$
|
2,479
|
$
|
1,524
|
Net income taxes paid
(received)
|
25
|
46
|
(328)
|
31
|
SOURCE Cardiome Pharma Corp.