UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
Report
of Foreign Private Issuer
Pursuant to Rule 13A-16
or 15d-16 of
The
Securities Exchange Act of 1934
For
the month of August 2017
COMMISSION
FILE Number.
000-29338
CARDIOME
PHARMA CORP.
(Translation
of registrant’s name into English)
1441
Creekside Drive, 6th floor
Vancouver,
British Columbia, V6J 4S7, CANADA
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS REPORT
Exhibit |
|
Description |
|
|
|
99.1 |
|
News Release dated August 8, 2017 - Cardiome Reports Second Quarter 2017 Financial Results |
|
|
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
|
CARDIOME
PHARMA CORP. |
|
(Registrant) |
|
|
|
Date: August 8, 2017 |
By: |
/s/
Justin Renz |
|
|
Name: Justin Renz |
|
|
Title: Chief Financial Officer |
Exhibit 99.1
Cardiome Reports Second Quarter 2017 Financial Results
NASDAQ: CRME TSX: COM
Management to Host Conference Call and
Webcast Today,
August 8, 2017 at 4:30 p.m. ET (1:30 p.m. PT)
VANCOUVER, Aug. 8, 2017 /CNW/ - Cardiome Pharma Corp. (NASDAQ:
CRME / TSX: COM) today reported financial results for the second quarter ended June 30, 2017 and commented on recent accomplishments
and plans.
"Our second quarter was marked by several business development
and regulatory accomplishments which pave the way for increased access to our products internationally," commented William
Hunter, MD, CEO and President of Cardiome. "Our commercial launch of BRINAVESS® in Canada continues to
expand our geographic footprint, and we look forward to making additional products available to our Canadian sales force as we
work alongside the provincial formularies. These efforts are expected to be supplemented by targeting Canadian NDS filings for
TREVYENT® and XYDALBA™ later this year. These achievements are important steps as we continue to
build a commercial portfolio of differentiated hospital products that address patient needs, and make these products available
through our global distribution capabilities."
Second Quarter 2017 and Recent Highlights
| · | Cardiome received authorization from Health Canada
to commercialize BRINAVESS® (vernakalant hydrochloride, IV) in Canada. The product is currently available on the
Ontario formulary, with a broader launch across multiple provincial formularies anticipated in the third quarter of 2017 and early
2018. |
| · | 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. |
| · | Cardiome's partner SteadyMed submitted a New Drug
Application to the U.S. Food and Drug Administration for TREVYENT® (treprostinil injection) for the treatment of
pulmonary arterial hypertension. This filing will assist Cardiome in preparing submissions for TREVYENT in both the European Union
and Canada before the end of 2017. |
| · | Cardiome signed an exclusive license and distribution
agreement with Tzamal Medical Ltd. to support the planned commercialization of XYDALBA™ (dalbavancin hydrochloride) in Israel,
anticipating a timely registration and launch within the next 18 months. |
| · | Cardiome announced changes to its senior management
team, including the appointment of Justin Renz as Chief Financial Officer, Jennifer Archibald as Chief Business Operations Officer,
David Dean as Chief Business Development Officer, and Hugues Sachot as Chief Commercial Officer. |
| · | Cardiome expanded its term loan agreement with CRG-managed
funds, providing the Company with up to $50 million of available borrowing capacity. |
| · | Cardiome's partner SteadyMed completed a TREVYENT®
(treprostinil injection) clinical validation study successfully demonstrating dose accuracy and precision of the PatchPump delivery
system. |
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 $8.5 million (basic loss per
share of $0.26) for the three months ended June 30, 2017, compared to a net loss of $7.5 million (basic loss per share of $0.37)
for the three months ended June 30, 2016. On a year-to-date basis, Cardiome recorded a net loss of $14.8 million (basic loss per
share of $0.46) for the six months ended June 30, 2017 compared to a net loss of $8.7 million (basic loss per share of $0.43) for
the six months ended June 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 June 30, 2017 was $5.8
million compared to revenue of $5.9 million for the three months ended June 30, 2016. Revenue for the six months ended June 30,
2017 and 2016 was $11.0 million and $13.0 million, respectively. The decrease in revenue for the six months ended June 30, 2017
was due to the timing of distributor sales. During the six months ended June 30, 2016, Cardiome recorded revenue of $1.7 million
from an annual order to a distributor. The annual order for 2017 from that distributor will be split into two orders and
Cardiome expects that at least one shipment will be shipped and recorded in the third quarter of this year.
Gross margin for the three and six months ended June 30, 2017
was 70.1% and 69.4%, respectively, compared to 71.5% and 76.1% for the three and six months ended June 30, 2016. The fluctuation
in gross margin is primarily due to changes in customer mix. A significant portion of Cardiome's sales during the three and six
months ended June 30, 2017 was to a distributor with lower margins.
SG&A expense for the three months ended June 30, 2017
was $9.6 million compared to $8.0 million for the three months ended June 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 six months ended June 30, 2017 was $17.8 million compared
to $14.2 million for the six months ended June 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.
Additionally, there was an increase of $1.6 million to the Company's stock-based compensation expense as a result of market fluctuations
in Cardiome's share price.
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 $1.4 million during the three and six months ended June 30, 2017.
Interest expense was $1.2 million for the three months ended
June 30, 2017, compared to $0.4 million for the three months ended June 30, 2016. The increase was due to an increase in long-term
debt in the second quarter of 2017 as the Company amended the terms of the CRG term loan agreement. On a year-to-date basis, interest
expense for the six months ended June 30, 2017 was $2.0 million compared to $0.9 million for the six months ended June 30, 2016.
The increase was due to interest being accrued on a higher long-term debt principal amount during the six months ended June 30,
2017.
Liquidity and Outstanding Share Capital
At June 30, 2017, the Company had cash and cash equivalents
of $28.4 million. As of August 7, 2017, there were 33,801,015 common shares issued and outstanding, and 2,919,557 common shares
issuable upon the exercise of outstanding stock options (of which 1,461,093 were exercisable) at a weighted average exercise price
of CAD $5.40 per share, and 108,673 restricted share units outstanding.
Conference Call
Cardiome will hold a conference call and webcast on Tuesday,
August 8, 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 72064400. The webcast can be accessed through Cardiome's website at www.cardiome.com or through the following link:
https://event.on24.com/wcc/r/1467066/DC894F8190C6D4AEF9EB1B450D4BF071
Webcast and telephone replays of the conference call will
be available approximately two hours after the completion of the call through September 8, 2017. Please dial 416-764-8677 or 888-390-0541
and enter code 064400 # to access the replay.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a specialty pharmaceutical company
dedicated to the development and commercialization of innovative therapies that will improve the quality of life and health of
patients suffering from disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESS® (vernakalant
IV), approved in Europe, Canada, and other countries for the rapid conversion of recent onset atrial fibrillation to sinus rhythm
in adults, and AGGRASTAT® (tirofiban hydrochloride) a reversible GP IIb/IIIa inhibitor indicated for use in patients
with acute coronary syndrome. Cardiome also commercializes ESMOCARD® and ESMOCARD LYO® (esmolol hydrochloride),
a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications, on behalf of their partner
Amomed in select European markets. Cardiome has also licensed: XYDALBA™ (dalbavancin hydrochloride), a second
generation, semi-synthetic lipoglycopeptide approved in the EU for the treatment of acute bacterial skin and skin structure infections
(ABSSSI) in adults for select European and Middle Eastern countries and Canada from Allergan; and TREVYENT®, a development
stage drug device combination that is under development for Pulmonary Arterial Hypertension for Europe, the Middle East and for
Canadian markets from SteadyMed Therapeutics.
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 May 15, 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 PHARMA CORP.
Interim Consolidated Balance Sheets
(Expressed in thousands of U.S. dollars, except share amounts)
|
June 30,
2017 |
December 31,
2016 |
|
|
Assets |
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
28,383 |
$ |
26,758 |
|
Restricted cash |
2,883 |
2,547 |
|
Accounts receivable, net of allowance for doubtful accounts of $110 (2016 - $97) |
5,397 |
6,154 |
|
Inventories |
6,366 |
4,618 |
|
Prepaid expenses and other assets |
1,214 |
1,302 |
|
|
44,243 |
41,379 |
|
|
Property and equipment |
480 |
548 |
Intangible assets |
23,717 |
24,352 |
Goodwill |
318 |
318 |
Deferred income tax assets |
461 |
460 |
|
$ |
69,219 |
$ |
67,057 |
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued liabilities |
$ |
7,333 |
$ |
8,021 |
|
|
Current portion of deferred consideration |
1,670 |
2,815 |
|
|
Current portion of deferred revenue |
197 |
182 |
|
|
|
9,200 |
|
11,018 |
|
|
|
|
Long-term debt, net of unamortized debt issuance costs and discount |
28,448 |
19,391 |
Deferred revenue |
2,479 |
2,381 |
Other long-term liabilities |
228 |
243 |
|
40,355 |
33,033 |
|
|
|
Stockholders' equity: |
|
|
|
Common stock |
352,390 |
344,928 |
|
|
|
Authorized - unlimited number without par value |
|
|
|
|
|
Issued and outstanding – 33,800,860 (2016 – 31,884,420) |
|
|
|
|
Additional paid-in capital |
37,508 |
35,812 |
|
|
Deficit |
(377,899) |
(363,054) |
|
|
Accumulated other comprehensive income |
16,865 |
16,338 |
|
|
|
|
28,864 |
|
34,024 |
|
|
|
$ |
69,219 |
$ |
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 |
Six months ended |
|
June 30,
2017 |
June 30,
2016 |
June 30,
2017 |
June 30,
2016 |
Revenue: |
|
|
|
|
|
Product and royalty revenues |
$ |
5,705 |
$ |
5,864 |
$ |
10,858 |
$ |
12,907 |
|
Licensing and other fees |
49 |
47 |
95 |
94 |
|
5,754 |
5,911 |
10,953 |
13,001 |
Cost of goods sold |
1,721 |
1,685 |
3,357 |
3,110 |
Gross margin |
4,033 |
4,226 |
7,596 |
9,891 |
Expenses: |
|
|
|
|
|
Selling, general and administration |
9,576 |
7,977 |
17,796 |
14,245 |
|
Amortization |
842 |
750 |
1,677 |
1,278 |
|
|
10,418 |
8,727 |
19,473 |
15,523 |
Operating loss |
(6,385) |
(4,501) |
(11,877) |
(5,632) |
|
|
|
|
|
Other expense: |
|
|
|
|
|
Loss on extinguishment of long-term debt |
- |
1,402 |
- |
1,402 |
|
Other expense on modification of long-term debt |
1,422 |
- |
1,422 |
- |
|
Interest expense |
1,247 |
445 |
2,034 |
850 |
|
Other expense |
29 |
111 |
107 |
335 |
|
Foreign exchange (gain) loss |
(559) |
961 |
(626) |
392 |
|
2,139 |
2,919 |
2,937 |
2,979 |
Loss before income taxes |
(8,524) |
(7,420) |
(14,814) |
(8,611) |
Income tax expense (recovery) |
(12) |
94 |
31 |
137 |
Net loss |
$ |
(8,512) |
$ |
(7,514) |
$ |
(14,845) |
$ |
(8,748) |
Other comprehensive income (loss): |
|
|
|
|
|
Foreign currency translation adjustments |
441 |
660 |
527 |
366 |
Comprehensive loss |
$ |
(8,071) |
$ |
(6,854) |
$ |
(14,318) |
$ |
(8,382) |
Loss per common share |
|
|
|
|
|
|
Basic |
$ |
(0.26) |
$ |
(0.37) |
$ |
(0.46) |
$ |
(0.43) |
|
|
Diluted |
$ |
(0.26) |
$ |
(0.37) |
$ |
(0.46) |
$ |
(0.46) |
Weighted average common shares
outstanding |
|
|
|
|
|
|
Basic |
32,441,211 |
20,358,724 |
32,168,840 |
20,329,011 |
|
|
Diluted |
32,441,211 |
20,358,724 |
32,168,840 |
20,404,593 |
|
|
|
|
|
|
CARDIOME PHARMA CORP.
Interim Consolidated Statements of Cash Flows
(Unaudited)
(Expressed in thousands of U.S. dollars)
|
|
|
|
|
|
|
Three months ended |
Six months ended |
|
June 30,
2017 |
June 30,
2016 |
June 30,
2017 |
June 30,
2016 |
Operating activities: |
|
|
|
|
Net loss |
$ |
(8,512) |
$ |
(7,514) |
$ |
(14,845) |
$ |
(8,748) |
Items not affecting cash: |
|
|
|
|
|
Amortization |
842 |
750 |
1,677 |
1,278 |
|
Amortization of deferred financing fees |
41 |
57 |
87 |
146 |
|
Accretion of long-term debt |
41 |
- |
41 |
- |
|
Write-down of inventory |
- |
- |
70 |
- |
|
Loss on extinguishment of long-term debt |
- |
1,402 |
- |
1,402 |
|
Stock-based compensation expense (recovery) |
937 |
420 |
1,330 |
(293) |
|
Unrealized foreign exchange gain (loss) |
(800) |
539 |
(972) |
353 |
Changes in operating assets and liabilities: |
|
|
|
|
|
Restricted cash |
2 |
3 |
(194) |
(295) |
|
Accounts receivable |
447 |
810 |
1,176 |
(512) |
|
Inventories |
(351) |
6 |
(1,482) |
(29) |
|
Prepaid expenses and other assets |
285 |
- |
102 |
(503) |
|
Accounts payable and accrued liabilities |
(411) |
1,946 |
(1,259) |
459 |
|
Deferred revenue |
(49) |
(47) |
(95) |
(94) |
|
Other long-term liabilities |
268 |
(7) |
260 |
(15) |
Net cash used in operating activities |
(7,260) |
(1,635) |
(14,104) |
(6,851) |
|
|
|
|
|
Investing activities: |
|
|
|
|
|
Purchase of property and equipment |
(5) |
- |
(5) |
(9) |
|
Purchase of intangible assets |
(1) |
(5,596) |
(13) |
(5,611) |
Net cash used in investing activities |
(6) |
(5,596) |
(18) |
(5,620) |
|
|
|
|
|
Financing activities: |
|
|
|
|
|
Issuance of common stock |
6,890 |
- |
6,890 |
841 |
|
Share issue costs |
(342) |
(7) |
(342) |
(30) |
|
Issuance of common stock upon exercise of stock options |
364 |
- |
384 |
- |
|
Income tax withholdings on vesting of restricted share units |
(47) |
(129) |
(49) |
(131) |
|
Proceeds from issuance of long-term debt |
10,000 |
20,000 |
10,000 |
20,000 |
|
Financing fees on issuance of long-term debt |
(150) |
(662) |
(150) |
(690) |
|
Repayment of long-term debt |
- |
(9,000) |
- |
(10,000) |
|
Payment of fees on extinguishment of long-term debt |
- |
(1,146) |
- |
(1,146) |
|
Payment of deferred consideration |
(547) |
(521) |
(1,145) |
(1,029) |
Net cash provided by financing activities |
16,168 |
8,535 |
15,588 |
7,815 |
|
|
|
|
|
Increase (decrease) in cash and cash equivalents during the period |
8,902 |
1,304 |
1,466 |
(4,656) |
Effect of foreign exchange rate changes on cash and cash equivalents |
108 |
43 |
159 |
(121) |
Cash and cash equivalents, beginning of period |
19,373 |
11,537 |
26,758 |
17,661 |
Cash and cash equivalents, end of period |
$ |
28,383 |
$ |
12,884 |
$ |
28,383 |
$ |
12,884 |
|
|
|
|
|
Supplemental cash flow information: |
|
|
|
|
Interest paid |
$ |
889 |
$ |
389 |
$ |
1,636 |
$ |
709 |
Net income taxes paid (received) |
35 |
(49) |
(353) |
(15) |
SOURCE Cardiome Pharma Corp.
View original content: http://www.newswire.ca/en/releases/archive/August2017/08/c8868.html
%CIK: 0001036141
For further information: Justin Renz, CFO, Cardiome Pharma
Corp., 604.677.6905 ext. 128, 800.330.9928, jrenz@cardiome.com
CO: Cardiome Pharma Corp.
CNW 16:00e 08-AUG-17
This regulatory filing also includes additional resources:
ex991.pdf
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