Rockwell Medical Reports Fourth Quarter Results
Q4 2016 Financial Highlights
- Sales were
$13.4 million , or$0.7 million lower than Q4 2015, primarily due to lower domestic and lower contract manufacturing concentrate sales. - Gross profit was
$2.0 million compared to$2.1 million in Q4 2015. - SG&A expense was
$6.0 million compared$6.1 million in Q4 2015. - R&D expense was
$1.2 million compared to$2.0 million in Q4 2015. - Net loss was
$5.1 million or ($0.10 ) per share compared to a$5.8 million loss or ($0.12 ) per share in Q4 2015. Net loss was$0.7 million less year over year primarily due to lower R&D expense of$0.8 million . - Cash and investments were
$57.9 million as ofDecember 31, 2016 . - Net working capital was
$68.4 million as ofDecember 31, 2016 .
2016 Financial Highlights
- Sales were
$53.3 million compared to$55.4 million in 2015, primarily due to lower contract manufacturing sales and lower international concentrate sales. - Gross profit was
$6.8 million compared to$8.9 million in 2015. Gross profit was impacted by increased drug product costs of$1.5 million , lower third party contract manufacturing revenue and a$0.2 million value add tax paid on the$4.0 million received from Wanbang Biopharma. - SG&A expense was
$21.1 million compared$19.1 million in 2015. - R&D expense was
$5.8 million compared to$5.0 million in 2015. - Net loss was
$19.8 million or ($0.39 ) per share versus$14.4 million or ($0.29 ) per share in 2015. - Cash used in operating activities in 2016 was
$12.5 million of which R&D related expense was$5.8 million and investment in Triferic inventory was$6.1 million .
2016 Corporate Highlights
- Made significant progress to secure transitional add-on reimbursement for Triferic.
- Formed wholly owned subsidiary in
India to initiate commercialization activities of Triferic inIndia . - Secured partnership in
Canada for distribution of Triferic. - Advanced clinical development with several new indications for Triferic, including peritoneal dialysis, total parenteral nutrition and orphan indication
IRIDA . - Triferic Phase-1 Healthy Volunteer Intravenous (IV)
Pharmacokinetic Study published in the
September 2016 edition of theJournal of Clinical Pharmacology . - Received
FDA approval to market Triferic powder packet. - Built redundancy into Triferic product supply chain to manage anticipated customer demand.
- Entered into license agreement with ARAM Medical to market Triferic in
Saudi Arabia ,Egypt and Middle Eastern countries. - Partnered with Wanbang Biopharma to commercialize Triferic and Calcitriol in the People's Republic of
China , receiving up to$39 million in milestone payments and ongoing profit on commercial product sales inChina .
Mr.
Conference Call Information
About Triferic
Triferic is the only
About
Rockwell's recent
Rockwell's
Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the
Rockwell's
exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to,
Rockwell's intention to sell and market Calcitriol and Triferic. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan", "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While
Triferic® is a registered trademark of
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES | |||||||||||||||||
CONSOLIDATED INCOME STATEMENTS | |||||||||||||||||
For the three and twelve months ended | |||||||||||||||||
Three Months Ended | Three Months Ended | 2016 | 2015 | ||||||||||||||
Sales | $ | 13,389,786 | $ | 14,132,637 | $ | 53,284,166 | $ | 55,350,702 | |||||||||
Cost of Sales | 11,401,603 | 12,076,489 | 46,531,648 | 46,412,848 | |||||||||||||
Gross Profit | 1,988,183 | 2,056,148 | 6,752,518 | 8,937,854 | |||||||||||||
Selling, General and Administrative | 6,049,663 | 6,089,606 | 21,120,901 | 19,078,867 | |||||||||||||
Research and Product Development | 1,200,729 | 2,029,736 | 5,840,346 | 4,961,313 | |||||||||||||
Operating Income (Loss) | (5,262,209 | ) | (6,063,194 | ) | (20,208,729 | ) | (15,102,326 | ) | |||||||||
Interest and Investment Income | 207,911 | 293,238 | 810,340 | 681,876 | |||||||||||||
Interest (Expense) | — | — | — | — | |||||||||||||
Income (Loss) Before Income Taxes | (5,054,298 | ) | (5,769,956 | ) | (19,398,389 | ) | (14,420,450 | ) | |||||||||
Income Tax Expense | — | — | (404,527 | ) | — | ||||||||||||
Net Income (Loss) | $ | (5,054,298 | ) | $ | (5,769,956 | ) | $ | (19,802,916 | ) | $ | (14,420,450 | ) | |||||
Basic Earnings (Loss) per Share | $ | (0.10 | ) | $ | (0.12 | ) | $ | (0.39 | ) | $ | (0.29 | ) | |||||
Diluted Earnings (Loss) per Share | $ | (0.10 | ) | $ | (0.12 | ) | $ | (0.39 | ) | $ | (0.29 | ) |
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
As of | |||||||||
2016 | 2015 | ||||||||
ASSETS | |||||||||
Cash and Cash Equivalents | $ | 17,180,594 | $ | 31,198,182 | |||||
Investments Available for Sale | 40,759,703 | 39,482,732 | |||||||
Accounts Receivable, net of a reserve of | 6,393,228 | 5,046,733 | |||||||
Inventory | 12,141,072 | 7,871,780 | |||||||
Other Current Assets | 2,034,598 | 1,026,889 | |||||||
Total Current Assets | 78,509,195 | 84,626,316 | |||||||
Property and Equipment, net | 1,391,575 | 1,646,568 | |||||||
Inventory, Non-Current | 1,826,554 | — | |||||||
Intangible Assets | 4,382 | 165,657 | |||||||
920,745 | 920,745 | ||||||||
Other Non-current Assets | 501,187 | 462,839 | |||||||
Total Assets | $ | 83,153,638 | $ | 87,822,125 | |||||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||
Accounts Payable | $ | 5,858,234 | $ | 3,995,216 | |||||
Accrued Liabilities | 4,210,151 | 3,831,356 | |||||||
Customer Deposits | 77,217 | 264,879 | |||||||
Total Current Liabilities | 10,145,602 | 8,091,451 | |||||||
Deferred License Revenue | 20,051,737 | 17,410,852 | |||||||
Shareholders' Equity: | |||||||||
Common Shares, no par value, 51,527,711 and 51,501,877 shares issued and outstanding | 268,199,939 | 257,773,494 | |||||||
Accumulated Deficit | (214,341,092 | ) | (194,538,176 | ) | |||||
Accumulated Other Comprehensive Income | (902,548 | ) | (915,496 | ) | |||||
Total Shareholders' Equity | 52,956,299 | 62,319,822 | |||||||
Total Liabilities And Shareholders' Equity | $ | 83,153,638 | $ | 87,822,125 | |||||
ROCKWELL MEDICAL, INC. AND SUBSIDIARIES | ||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
For the years ended | ||||||||
2016 | 2015 | |||||||
Cash Flows From Operating Activities: | ||||||||
Net (Loss) | $ | (19,802,916 | ) | $ | (14,420,450 | ) | ||
Adjustments To Reconcile Net Loss To | ||||||||
Depreciation and Amortization | 762,368 | 822,294 | ||||||
Share Based Compensation—Employees | 10,346,284 | 8,887,977 | ||||||
Restricted Stock Retained in Satisfaction of Tax Liabilities | — | (2,912,859 | ) | |||||
Loss on Disposal of Assets | 8,168 | 5,281 | ||||||
Loss on Sale of Investments Available for Sale | 26,820 | 58,095 | ||||||
Changes in Assets and Liabilities: | ||||||||
(Increase) in Accounts Receivable | (1,162,469 | ) | (574,731 | ) | ||||
(Increase) in Inventory | (6,095,846 | ) | (3,951,595 | ) | ||||
(Increase) in Other Assets | (1,230,084 | ) | (360,303 | ) | ||||
(Decrease) in Accounts Payable | 1,863,018 | (1,299,299 | ) | |||||
(Decrease) in Other Liabilities | 191,134 | (413,652 | ) | |||||
Increase (decrease) in Deferred License Revenue | (2,065,785 | ) | (2,081,668 | ) | ||||
Increase (decrease) in Deferred Drug License Revenue | 4,706,670 | — | ||||||
Changes in Assets and Liabilities | (3,793,362 | ) | (8,681,248 | ) | ||||
Cash (Used) In Provided By Operating Activities | (12,452,638 | ) | (16,240,910 | ) | ||||
Cash Flows From Investing Activities: | ||||||||
Purchase of Investments Available for Sale | (25,781,853 | ) | (21,800,000 | ) | ||||
Sale of Investments Available for Sale | 24,491,677 | 1,468,656 | ||||||
Purchase of Equipment | (355,264 | ) | (815,002 | ) | ||||
Proceeds on Sale of Assets | 1,000 | 4,800 | ||||||
Cash (Used In) Investing Activities | (1,644,440 | ) | (21,141,546 | ) | ||||
Cash Flows From Financing Activities: | ||||||||
Proceeds from Issuance of Common Shares and Purchase Warrants | 80,161 | 2,780,187 | ||||||
Cash Provided By Financing Activities | 80,161 | 2,780,187 | ||||||
Effects of exchange rate changes | (671 | ) | — | |||||
(Decrease) Increase In Cash | (14,017,588 | ) | (34,602,269 | ) | ||||
Cash At Beginning Of Period | 31,198,182 | 65,800,451 | ||||||
Cash At End Of Period | $ | 17,180,594 | $ | 31,198,182 | ||||
Source:Michael Rice , Investor Relations; 646-597-6979
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