Delaware
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000-23661
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38-3317208
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)
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Title of Each Class
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Trading Symbol
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Name of Each exchange on which registered
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Common Stock, par value $0.0001
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RMTI
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Nasdaq Global Market
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Exhibit No.
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Description
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99.1
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ROCKWELL MEDICAL, INC.
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Date: May 11, 2020
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By:
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/s/ Russell Ellison
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Russell Ellison
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Chief Executive Officer
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Exhibit 99.1
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•
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The Company currently has active or committed Evaluation Programs with independent dialysis clinics and small dialysis chains representing more than 2,250 patients and 36 clinics, a 260% increase from December 31, 2019.
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•
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Signed contracts with four additional clinics during the first quarter of 2020, and an additional eight clinics that are affiliated with MDO were trained and approved for adoption as of March 31, 2020.
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•
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Nearly 2,000 contracted patients on therapy as of March 31, 2020, representing over 300,000 annualized treatments.
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•
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Triferic net sales were $0.3 million in the first quarter of 2020.
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•
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Entered into exclusive license and supply agreements with Sun Pharma for the rights to commercialize Triferic Dialysate in India. Rockwell Medical received an upfront fee and will be eligible for milestone payments and royalties on net sales.
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•
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With respect to the COVID-19 pandemic, the Company has implemented precautions to reduce the risk of possible exposure by restricting employee travel, adopting new preventative safety measures within our manufacturing facilities, instituting a work-from-home policy for substantially all employees, excluding our essential manufacturing and distribution employees, and leveraging virtual technology for the sales force to use in its communications with customers. The Company has experienced no material impact on its supply chain to date, and has experienced a small increase in demand for its dialysis concentrates products, believed to be attributed to customers building safety stock and turning to Rockwell Medical in instances where other suppliers have not been able to meet demand.
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•
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On March 27, 2020, Rockwell Medical announced that the FDA approved its New Drug Application for Triferic AVNU, its intravenous formulation of Triferic.
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•
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With this approval, Triferic AVNU joins Triferic Dialysate as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.
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The Company has initiated a commercial strategy to leverage the experience gained from the 2019 launch of Triferic Dialysate and lay the groundwork for the commercial introduction of Triferic AVNU. The Company expects to launch evaluation programs during the third quarter of 2020 to allow clinics to gain direct experience with Triferic AVNU, and expects Triferic AVNU to be available commercially during the fourth quarter of 2020, following the completion of the initial evaluation programs.
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•
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A more than 23% reduction in ESAs utilized per patient, per week during the sixth quarter after Triferic Dialysate administration vs. baseline.
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A 74% reduction in traditional IV iron (ferric gluconate) utilization per patient, per week, beginning at month 3 and continuing through the observation period vs. baseline.
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Stable to increasing hemoglobin levels, with consistent hemoglobin control throughout the observation period.
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A meaningful reduction in missed treatments of nearly one-fifth and one-half for the 5th and 6th quarters, respectively.
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Improvements in key quality of life indicators as measured by KDQOLTM-36.
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The Company announced the appointment of Russell H. Ellison, M.D., M.Sc., as President and Chief Executive Officer, effective April 20, 2020. Dr. Ellison, who will continue to serve as a member of the Board of Directors for Rockwell Medical, brings broad medical, clinical development and leadership experience to the role.
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The Company announced the appointment of Robert S. Radie to its Board of Directors, effective March 31, 2020. Mr. Radie brings more than three decades of industry experience, working in senior executive roles with both public and private pharmaceutical and biotech companies across a range of therapeutic areas.
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On March 17, 2020, the Company entered into a debt financing agreement with an affiliate of Innovatus Capital Partners, LLC ("Innovatus") to provide the Company with up to $35.0 million in term loans. The first $22.5 million tranche was funded on March 16, 2020. The Company will be eligible to draw on a second tranche of $5.0 million following the completion of certain milestones, which includes the FDA approval of Triferic AVNU, and
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•
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The Company completed the pricing of an underwritten public offering of the Company’s common stock in February 2020 for gross proceeds of approximately $8.1 million, before deducting issuance costs.
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March 31, 2020
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December 31, 2019
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ASSETS
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Cash and Cash Equivalents
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$
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37,399,801
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$
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11,794,526
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Investments Available-for-Sale
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11,456,285
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14,250,176
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Accounts Receivable, net
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4,586,748
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4,202,725
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Inventory
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4,292,768
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3,646,906
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Prepaid and Other Current Assets
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1,758,002
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2,979,504
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Total Current Assets
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59,493,604
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36,873,837
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Property and Equipment, net
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2,430,113
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2,433,405
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Inventory, Non-Current
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623,000
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441,000
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Right of Use Assets, net
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2,797,759
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3,212,530
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Goodwill
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920,745
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920,745
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Other Non-Current Assets
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560,588
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434,935
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Total Assets
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$
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66,825,809
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$
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44,316,452
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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Accounts Payable
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$
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3,123,181
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$
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3,018,424
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Accrued Liabilities
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6,160,047
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4,517,732
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Settlement Payable
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57,000
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104,000
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Lease Liability - Current
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1,351,348
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1,493,394
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Deferred License Revenue - Current
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2,179,383
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2,233,640
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Insurance Financing Note Payable
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190,855
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763,422
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Customer Deposits
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146,831
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55,100
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Other Current Liability - Related Party
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148,523
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187,849
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Total Current Liabilities
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13,357,168
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12,373,561
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Lease Liability - Long-Term
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1,559,749
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1,780,626
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Term Loan, Net of Issuance Costs
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20,683,704
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—
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Deferred License Revenue - Long-Term
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9,450,983
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9,842,762
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Total Liabilities
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45,051,604
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23,996,949
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Stockholders’ Equity:
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Preferred Stock, $0.0001 par value, no shares issued and outstanding at March 31, 2020 and December 31, 2019
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—
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—
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Common Stock, $0.0001 par value; 170,000,000 shares authorized; 69,049,102 and 65,378,890 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
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6,905
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6,538
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Additional Paid-in Capital
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336,216,422
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326,777,250
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Accumulated Deficit
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(314,500,003
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)
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(306,516,265
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)
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Accumulated Other Comprehensive Income
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50,881
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51,980
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Total Stockholders’ Equity
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21,774,205
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20,319,503
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Total Liabilities And Stockholders’ Equity
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$
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66,825,809
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$
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44,316,452
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Three Months Ended March 31, 2020
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Three Months Ended March 31, 2019
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Net Sales
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$
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15,856,539
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$
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15,559,439
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Cost of Sales
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14,743,613
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14,549,047
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Gross Profit
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1,112,926
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1,010,392
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Selling and Marketing
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2,072,798
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3,102,378
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General and Administrative
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5,273,433
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6,220,499
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Research and Product Development
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1,821,488
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497,276
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Operating Loss
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(8,054,793
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)
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(8,809,761
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)
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Other Income (Expense)
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Realized Gain on Investments
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1,929
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13,888
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Interest Expense
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(101,951
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)
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—
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Interest Income
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171,077
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117,526
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Total Other Income
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71,055
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131,414
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Net Loss
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$
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(7,983,738
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)
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$
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(8,678,347
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Basic and Diluted Net Loss per Share
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$
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(0.12
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)
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$
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(0.15
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Basic and Diluted Weighted Average Shares Outstanding
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67,518,240
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57,098,947
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