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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Correvio Pharma Corporation | NASDAQ:CORV | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.4199 | 0.4311 | 0.35 | 0 | 01:00:00 |
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 May 2019
COMMISSION FILE Number. 000-29338
CORREVIO 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
Form 20-F ☐ | 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 May 8, 2019 | |
Exhibit 99.1 of this report on Form 6-K is incorporated by reference into the Company’s registration statement on Form F-10 (File No. 333-225852) and registration statements on Form S-8 (File No. 333-225015 and File No. 333-225014).
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.
CORREVIO PHARMA CORP. | ||
(Registrant) | ||
Date: May 8, 2019 | By: | /s/ Justin Renz |
Name: Justin Renz | ||
Title: President and Chief Financial Officer |
Exhibit 99.1
Correvio Reports First Quarter 2019 Financial Results
Mark H.N. Corrigan, MD Commences Role as CEO, effective March 14, 2019
Company on Track to Resubmit Brinavess NDA in Q2 2019
Management to Host Conference
Call and Webcast Today,
May 8, 2019 at 8:30 a.m. Eastern (5:30 a.m. Pacific)
NASDAQ: CORV TSX: CORV
VANCOUVER, May 8, 2019 /CNW/ - Correvio Pharma Corp. (NASDAQ: CORV / TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today reported financial results for its first quarter ended March 31, 2019 and commented on recent accomplishments and plans.
"2019 is off to a strong start with first quarter revenues up 16% year-over-year in local currencies," commented Mark H.N. Corrigan, MD, CEO of Correvio. "Our first quarter revenues from Xydalba and Zevtera doubled year-over-year. Looking ahead, we remain on track to resubmit the New Drug Application seeking approval in the U.S. for BrinavessTM as a new treatment for adult patients with recent onset atrial fibrillation during the second quarter of 2019."
First Quarter 2019 and Recent Highlights
Zevtera®/Mabelio® and Xydalba™
Brinavess®
Corporate and Financial
First Quarter 2019 Financial 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).
Correvio recorded a net loss of $9.0 million (basic loss per share of $0.23) for the three months ended March 31, 2019, compared to a net loss of $8.5 million (basic loss per share of $0.24) for the three months ended March 31, 2018. The increase in net loss was due primarily to an increase in interest expense and foreign exchange losses, partially offset by an increase in revenue.
Revenue for the three months ended March 31, 2019 was $7.3 million, compared to revenue of $6.5 million for the three months ended March 31, 2018. The 11% increase in revenue was primarily due to increased antibiotic product sales. Xydalba and Zevtera combined for approximately $2.6 million in revenue in the first quarter of 2019, compared to approximately $1.3 million in the first quarter of 2018. Direct market sales for the three months ended March 31, 2019, increased by approximately 17% year-over-year from $3.8 million to $4.4 million. Distributor sales for the three months ended March 31, 2019, increased by approximately 2% year-over-year.
Cost of goods sold ("COGS") for the three months ended March 31, 2019 was $2.2 million, compared to COGS of $2.3 million for the three months ended March 31, 2018.
SG&A expense for the three months ended March 31, 2019 was $11.2 million, compared to $10.9 million for the three months ended March 31, 2018. The increase in SG&A expense was due to an increase in stock-based compensation expense.
Interest expense was $1.7 million for the three months ended March 31, 2019, compared to $1.1 million for the three months ended March 31, 2018. The increase was due to interest being accrued on a higher long-term debt principal amount under the CRG Term Loan during the three months ended March 31, 2019 as well as an increase in the accretion of our long-term debt under the effective interest method which is recorded as interest expense.
Liquidity and Outstanding Share Capital
At March 31, 2019, the Company had cash and cash equivalents of $16.0 million. As of May 7, 2019, there were 39,854,667 common shares issued and outstanding, and 4,562,374 common shares issuable upon the exercise of outstanding stock options (of which 2,989,861 were exercisable) at a weighted average exercise price of CAD $5.10 per share, and 128,402 restricted share units outstanding.
Conference Call
Correvio will hold a teleconference and webcast on May 8, 2019 at 8:30 a.m. Eastern (5:30 a.m. Pacific). To access the conference call, please dial 416-764-8688 or 888-390-0546 and use conference ID 06912690. The webcast can be accessed through the following link:
https://event.on24.com/wcc/r/1990156/ED2B6FC2DB221FB04C9C654C8CA75B2B
Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through May 22, 2019. Please dial 416-764-8677 or 888-390-0541 and enter code 912690 # to access the replay.
About Correvio Pharma Corp.
Correvio Pharma Corp. is a 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, Correvio 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, excluding ventilator-associated pneumonia, VAP); Brinavess®TM (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 betablocker used to control rapid heart rate in a number of cardiovascular indications. Correvio's pipeline of product candidates includes Trevyent®, a drug device combination that is designed to deliver treprostinil, the world's leading treatment for pulmonary arterial hypertension.
Correvio is traded on the NASDAQ Capital Market (CORV) and the Toronto Stock Exchange (CORV). For more information, please visit our web site www.correvio.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 or "forward-looking information" under applicable Canadian securities legislation (collectively, "forward-looking statements"). Forward-looking statements include statements that may relate to our plans, objectives, goals, strategies, future events, future revenue or performance, capital expenditures, financing needs and other information that may not be based on historical fact. Forward-looking statements can often be identified by the use of terminology such as "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect", "look forward to" and similar expressions. Forward-looking statements are necessarily based on estimates and assumptions made by us based on our experience and perception of historical trends, current conditions and expected future developments, as well as other factors we believe are appropriate.
By their very nature, 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. These forward-looking statements include, but are not limited to, our possible regulatory path forward with Brinavess in the U.S., including the resubmission of a New Drug Application and the timing of such resubmission. A detailed discussion of the risks and uncertainties facing Correvio are discussed in the annual report and detailed from time to time 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. In particular, we direct your attention to Correvio's Annual Report on Form 40-F for the year ended December 31, 2018. All of the risks and certainties disclosed in those filings are hereby incorporated by reference in their entirety into this news release.
While Correvio makes these forward-looking statements in good faith, given these risks, uncertainties and factors, you are cautioned not to place undue reliance on any forward-looking statements made in this press release. All forward-looking statements made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements to reflect subsequent events or circumstances, except as required by law. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to their inherent uncertainty.
Correvio® and the Correvio Logo
are the proprietary trademarks of Correvio Pharma Corp.
Aggrastat® and Brinavess®TM are trademarks owned by Correvio and its affiliates worldwide.
Xydalba™ is a trademark of Allergan Pharmaceuticals International Limited, and used under license.
Zevtera® and Mabelio® are trademarks owned by Basilea Pharmaceutica Ltd. and its affiliates, 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 Ltd. and used under license.
All other trademarks are the property of their respective owners.
CORREVIO PHARMA CORP.
(formerly Cardiome Pharma Corp.)
Interim Consolidated Balance Sheets
(In thousands of U.S. dollars, except share amounts)
March 31, 2019 |
December 31, 2018 | |||
Assets | ||||
Current assets: | ||||
Cash and cash equivalents | $ | 15,962 | $ | 15,596 |
Restricted cash | 1,939 | 1,974 | ||
Accounts receivable, net of allowance for doubtful accounts of $95 (2018 - $102) |
7,988 | 7,723 | ||
Inventories | 4,460 | 4,158 | ||
Prepaid expenses and other assets | 2,723 | 841 | ||
33,072 | 30,292 | |||
Property and equipment | 539 | 512 | ||
Right-of-use assets from operating leases | 2,294 | - | ||
Intangible assets | 25,047 | 26,469 | ||
Long-term inventories | 1,668 | 1,663 | ||
Goodwill | 318 | 318 | ||
Deferred income tax assets | 369 | 383 | ||
$ | 63,307 | $ | 59,637 | |
Liabilities and Stockholders' Equity | ||||
Current liabilities: | ||||
Accounts payable and accrued liabilities | $ | 11,093 | $ | 9,403 |
Current operating lease liabilities | 726 | - | ||
11,819 | 9,403 | |||
Long-term debt, net of unamortized debt issuance costs | 42,315 | 41,517 | ||
Deferred revenue | 1,228 | 1,252 | ||
Long-term operating lease liabilities | 1,816 | - | ||
Other long-term liabilities | 4 | 555 | ||
57,182 | 52,727 | |||
Stockholders' equity: | ||||
Common stock | 367,350 | 359,295 | ||
Authorized - unlimited number without par value | ||||
Issued and outstanding – 39,854,169 (2018 – 36,233,162) | ||||
Additional paid-in capital | 40,952 | 40,456 | ||
Deficit | (418,740) | (409,744) | ||
Accumulated other comprehensive income | 16,563 | 16,903 | ||
6,125 | 6,910 | |||
$ | 63,307 | $ | 59,637 |
CORREVIO PHARMA CORP.
(formerly Cardiome Pharma Corp.)
Interim Consolidated Statements of Operations and Comprehensive Loss
For the three months ended March 31, 2019 and 2018
(In thousands of U.S. dollars, except share and per share amounts)
(Unaudited)
March 31, 2019 |
March 31, 2018 | |||||
Revenue: | ||||||
Product and royalty revenues | $ | 7,251 | $ | 6,518 | ||
Licensing and other fees | - | 25 | ||||
7,251 | 6,543 | |||||
Cost of goods sold | 2,241 | 2,301 | ||||
Gross margin | 5,010 | 4,242 | ||||
Expenses: | ||||||
Selling, general and administration | 11,191 | 10,902 | ||||
Amortization and depreciation | 984 | 955 | ||||
12,175 | 11,857 | |||||
Operating loss | (7,165) | (7,615) | ||||
Other expense: | ||||||
Interest expense | (1,690) | (1,063) | ||||
Other expense | (98) | (113) | ||||
Foreign exchange (loss) gain | (16) | 386 | ||||
(1,804) | (790) | |||||
Loss before income taxes | (8,969) | (8,405) | ||||
Income tax expense | (27) | (55) | ||||
Net loss | $ | (8,996) | $ | (8,460) | ||
Other comprehensive loss: | ||||||
Foreign currency translation adjustments | (340) | 145 | ||||
Comprehensive loss | $ | (9,336) | $ | (8,315) | ||
Loss per common share | ||||||
Basic and diluted | $ | (0.23) | $ | (0.24) | ||
Weighted average common shares outstanding | ||||||
Basic and diluted | 38,819,002 | 34,653,514 | ||||
CORREVIO PHARMA CORP.
(formerly Cardiome Pharma Corp.)
Interim Consolidated Statements of Cash Flows
For the three months ended March 31, 2019 and 2018
(In thousands of U.S. dollars)
(Unaudited)
March 31, 2019 |
March 31, 2018 | |||
Operating activities: | ||||
Net loss | $ | (8,996) | $ | (8,460) |
Items not affecting cash: | ||||
Amortization and depreciation | 984 | 955 | ||
Accretion of long-term debt | 373 | (241) | ||
Interest paid in-kind on long-term debt | 425 | 408 | ||
Stock-based compensation expense | 618 | 395 | ||
Write-down of inventory | 50 | 118 | ||
Unrealized foreign exchange loss (gain) | 317 | (528) | ||
Changes in operating assets and liabilities: | ||||
Accounts receivable | (595) | (890) | ||
Inventories | (419) | 312 | ||
Prepaid expenses and other assets | (1,882) | (177) | ||
Deferred revenue | - | (25) | ||
Accounts payable and accrued liabilities | 1,534 | (387) | ||
Other long-term liabilities | (20) | (8) | ||
Net cash used in operating activities | (7,611) | (8,528) | ||
Investing activities: | ||||
Proceeds of disposal of Canadian Operations | 190 | - | ||
Purchase of property and equipment | (68) | (202) | ||
Purchase of intangible assets | (12) | - | ||
Net cash provided by (used in) investing activities | 110 | (202) | ||
Financing activities: | ||||
Issuance of common stock | 8,347 | - | ||
Share issue costs | (405) | - | ||
Issuance of common stock upon exercise of stock options | - | 258 | ||
Income tax withholdings on vesting of restricted share units | - | (21) | ||
Financing fees on issuance of long-term debt | - | (21) | ||
Net cash provided by financing activities | 7,942 | 216 | ||
Increase (decrease) in cash, cash equivalents, and restricted cash | 441 | (8,514) | ||
during the period | ||||
Effect of foreign exchange rate changes on cash, cash equivalents, | (110) | 91 | ||
and restricted cash | ||||
Cash, cash equivalents, and restricted cash, beginning of period | 17,570 | 24,181 | ||
Cash, cash equivalents, and restricted cash, end of period | $ | 17,901 | $ | 15,758 |
Supplemental cash flow information: | ||||
Interest paid | $892 | $897 | ||
Cash paid for income taxes | - | 16 |
View original content:http://www.prnewswire.com/news-releases/correvio-reports-first-quarter-2019-financial-results-300846074.html
SOURCE Correvio Pharma Corp
View original content: http://www.newswire.ca/en/releases/archive/May2019/08/c7460.html
%CIK: 0001036141
For further information: Justin Renz, President & CFO, Correvio Pharma Corp., 604.677.6905 ext. 128, 800.330.9928, jrenz@correvio.com; Argot Partners: Michelle Carroll/Claudia Styslinger, 212.600.1902, michelle@argotpartners.com, claudia@argotpartners.com
CO: Correvio Pharma Corp
CNW 08:00e 08-MAY-19
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