Rockwell Medical, Inc. Reports Second Quarter 2019 Financial Results
– Company Records First Commercial Sales of Dialysate Triferic®; FDA Accepts New Drug Application for I.V. Triferic with PDUFA date of
Recent Business and Financial Highlights:
- Launched the initial product in the Triferic (ferric pyrophosphate citrate) portfolio, Dialysate Triferic, on
May 6, 2019and recorded its first commercial sales. The Company’s goal for 2019 is to drive adoption by providing medical education to healthcare providers, while increasing awareness and understanding of Triferic’s potential benefits.
- Submitted a New Drug Application (“NDA”) for I.V. Triferic in the U.S. during the second quarter and received notice of acceptance for filing from the
U.S. Food and Drug Administration(“FDA”) on August 2, 2019with a PDUFA date of March 28, 2020.
- Announced positive results of two clinical pharmacology trials of Triferic in
China. Rockwell Medicaland its partner in Chinaexpect to request a meeting with the National Medical Products Administration(“NMPA”) to review the results of these studies and discuss whether these studies are sufficient to support a submission for regulatory approval for Dialysate Triferic.
- Received a new J-Code from the
Centers for Medicare and Medicaid Services(“CMS”), effective July 1, 2019, for the powder packet formulation of Dialysate Triferic.
- Intends to provide comments supporting eligibility of I.V. Triferic for TDAPA in response to the recently announced CMS ESRD Proposed Rule for 2020.
- Sales were
$14.8 millionand $30.4 millionfor the three and six months ended June 30, 2019, a decrease of 0.5% and increase of 1.8% over the same periods last year, respectively. The Company’s sales during the quarter and to date have substantially consisted of sales of dialysis concentrate products to DaVita, Baxter and international customers. The Company recently signed a new Products Purchase Agreement with DaVitawith an initial term through December 31, 2023and supplies approximately 25% of the U.S. market for dialysis concentrates.
- Completed a public offering of common stock, with gross proceeds of
- As of
June 30, 2019, the Company had cash, cash equivalents and investments available-for-sale of $35.2 million. Additionally, the Company has approximately $38 millionremaining under its at-the-market equity offering facility, pursuant to which the Company may sell, at such times and amounts as it deems appropriate, shares of common stock to support its business plan, subject to certain restrictions on use.
“During the second quarter, we accomplished two critical milestones: commercializing Dialysate Triferic and submitting our NDA for the I.V. Triferic formulation. We are pleased with the progress we have made in a relatively short time. Through our medical education, sales and marketing efforts, we have begun the process of converting U.S. dialysis clinics to commercial use of Dialysate Triferic, and we believe these efforts will support our launch of I.V. Triferic next year, if approved by the FDA,” stated
“Our recent financing strengthens our balance sheet and supports our global commercialization and research and development efforts around Triferic. And, while we are disappointed with CMS’s proposed revisions as set forth in the ESRD Proposed Rule for 2020, we remain confident about Triferic’s future and potential to change the standard of care in anemia management for hemodialysis patients,” continued Mr. Paul.
Second Quarter 2019 Financial Results
Net loss for the second quarter of 2019 was $10.3 million, or
Net sales for the second quarter of 2019 were
Cost of sales for the second quarter of 2019 was
Selling and marketing expenses were
General and administrative expenses were
Settlement expense, net of reimbursement, was
Research and product development expenses were
Other income, net, for the three months ended
The Company encourages shareholders to also review its Form 10-Q for the quarter ended
Key Objectives for 2019
- Drive adoption of Dialysate Triferic in the U.S. by raising awareness in the dialysis community of its unique benefits.
- Gather and analyze real-world data to support medical education and commercial efforts for Triferic.
- Interact with the
FDAto support potential approval of I.V. Triferic in March 2020and begin preparation for potential launch of I.V. Triferic.
- Use results from recently completed clinical pharmacology studies in
Chinato support future regulatory submission to NMPA (formerly, the CFDA).
- Advance international opportunities for the Triferic portfolio through strategic partnerships and licensing agreements.
- Expand and improve operating margin for the Company’s concentrates business.
As previously announced,
|Date||Thursday, August 8, 2019|
|Time||4:30 PM EDT|
|Telephone U.S:||(877) 383-7438|
|Webcast (live and archive)||https://edge.media-server.com/mmc/p/w4hd4fhc|
Triferic is the only
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell Medical’s intention to bring to market Triferic, and I.V. Triferic. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "plan," "potential," "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
Financial Tables Follow
|ROCKWELL MEDICAL, INC. AND SUBSIDIARIES|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Cash and Cash Equivalents||$||21,417,159||$||22,713,980|
|Investments Available-for -Sale||13,816,079||10,818,059|
|Accounts Receivable, net||5,388,858||6,979,514|
|Prepaid and Other Current Assets||3,667,605||1,903,682|
|Total Current Assets||48,262,338||46,825,230|
|Property and Equipment, net||2,563,428||2,638,293|
|Right of Use Assets, net||3,329,481||—|
|Other Non-current Assets||555,222||536,516|
|LIABILITIES AND SHAREHOLDERS’ EQUITY|
|Lease Liability - Current||1,637,481||—|
|Deferred License Revenue - Current||2,243,256||2,252,868|
|Insurance Financing Note Payable||1,908,554||—|
|Other Current Liability - Related Party||350,000||850,000|
|Total Current Liabilities||14,834,588||13,204,511|
|Lease Liability - Long-Term||1,690,310||—|
|Deferred License Revenue - Long-Term||10,959,577||12,076,399|
|Preferred Shares, no par value, no shares issued and outstanding at June 30, 2019 and December 31, 2018||—||—|
|Common Shares, no par value, 63,398,704 and 57,034,154 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively||320,882,946||299,601,960|
|Accumulated Other Comprehensive Income||67,557||63,148|
|Total Shareholders’ Equity||29,591,739||27,276,874|
|Total Liabilities And Shareholders’ Equity||$||57,076,214||$||52,557,784|
|ROCKWELL MEDICAL, INC. AND SUBSIDIARIES|
|Condensed Consolidated Statements of Operations|
|Three Months Ended June 30, 2019||Three Months Ended June 30, 2018||Six Months Ended June 30, 2019||Six Months Ended June 30, 2018|
|Cost of Sales||14,112,639||18,930,371||28,661,686||34,599,442|
|Gross Profit (Loss)||733,149||(4,017,008||)||1,743,541||(4,737,499||)|
|Selling and Marketing||2,218,997||164,374||5,321,375||379,457|
|General and Administrative||5,496,670||5,526,575||11,717,169||8,643,449|
|Settlement Expense, net||430,000||1,030,000||430,000||1,030,000|
|Research and Product Development||2,958,276||1,558,946||3,455,552||3,225,302|
|Realized Gain (Loss) on Investments||4,135||(122,095||)||18,023||(124,987||)|
|Total Other Income||78,611||66,111||210,025||235,394|
|Basic and Diluted Net Loss per Share||$||(0.18||)||$||(0.24||)||$||(0.33||)||$||(0.35||)|
|Basic and Diluted Weighted Average Shares Outstanding||58,216,066||51,288,424||57,660,947||51,288,424|
Source: Rockwell Medical, Inc.