Document
false0001041024 0001041024 2020-08-07 2020-08-07


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


 

FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934


 
Date of Report (Date of earliest event reported):  August 10, 2020
 
ROCKWELL MEDICAL, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
000-23661
38-3317208
(State or other jurisdiction
of incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
 
411 Hackensack Avenue, Suite 501, Hackensack, New Jersey 07601
(Address of principal executive offices, including zip code)
 
(248) 960-9009
(Registrant’s telephone number, including area code)
 
Not Applicable
(Former name or former address, if changed since last report)


  
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of Each Class
 
Trading Symbol
 
Name of Each exchange on which registered
Common Stock, par value $0.0001
 
RMTI
 
Nasdaq Global Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).





 
Emerging growth company 
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
 







Item 2.02        Results of Operations and Financial Condition.

On August 10, 2020, Rockwell Medical, Inc. issued a press release and earnings presentation announcing its financial results for the quarter ended June 30, 2020. The press release and earnings presentation are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8‑K.

As provided in General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibits 99.1 and 99.2 incorporated in this Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall such information or Exhibits 99.1 and 99.2 be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01        Financial Statements and Exhibits.

(d) Exhibits        The following exhibit is being furnished herewith:

EXHIBIT INDEX
 
Exhibit No.
 
Description
 
 
 
99.1
 
99.2
 
104
 
Cover Page Interactive Data File, formatted in INline XBRL and included as Exhibit 101.






SIGNATURE
 
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 hereunto duly authorized.
 
 
ROCKWELL MEDICAL, INC.
 
 
 
Date: August 10, 2020
By: 
/s/ Russell Ellison
 
 
Russell Ellison
 
 
Chief Executive Officer



Exhibit
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Exhibit 99.1

Rockwell Medical, Inc. Provides Second Quarter 2020 Financial and Operational Update

-Q2 2020 revenue of $15.9 million-

-Increase in contracted clinics of 44 percent quarter-over-quarter-

-Reached contracted annualized treatment volume for Triferic Dialysate of over 400,000-

- $40.0 million in cash, cash equivalents and investments available-for-sale as of June 30, 2020-
 
-Q2 2020 conference call and webcast scheduled for today at 4:30 p.m. ET-

- Management/KOL conference call and webcast scheduled for September 24, 2020, to review our prioritization programs for new potential FPC indications-

WIXOM, Mich., August 10, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today reported financial results and a business update for the three months ended June 30, 2020.

“In the second quarter, we continued to make important progress in the commercialization of Triferic Dialysate, despite the challenges of the COVID-19 pandemic. We significantly increased the number of clinics contracted to administer the therapy, and we reached the highest number of contracted patients on therapy and contracted annualized treatment volume since launch,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “We continue to diligently prepare for a successful launch of Triferic AVNU in the United States later this year.”

“Importantly, we value the scientific underpinning of our ferric pyrophosphate citrate technology and the potential this represents in the treatment of iron deficiency and anemia. Approximately 10 million people are iron deficient in the United States, including 5 million who have iron deficiency anemia. We are committed to prudent medical and scientific advancements, and look forward to reviewing our programs for two therapeutic indications that, we believe, represent new opportunities to extend the innovative potential of our platform.”

Second Quarter 2020 Operational Highlights

Triferic Dialysate

The Company signed contracts with 12 additional clinics during the second quarter of 2020, an increase of 44% in contracted clinics as compared to March 31, 2020. An additional eight clinics affiliated with a Medium-Sized Dialysis Organization (MDO) were trained and



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approved for adoption as of June 30, 2020. Substantially all clinics contracted within Q2 2020 signed and began purchasing in June 2020.

There were nearly 2,800 contracted patients on therapy as of June 30, 2020, representing more than 400,000 annualized treatments. This compares to nearly 2,000 contracted patients and over 300,000 annualized treatments as of March 31, 2020.

The Company, as of June 30, 2020, has active or committed Evaluation Programs with independent dialysis clinics and small and medium dialysis chains representing nearly 1,500 patients and 26 clinics.

Triferic net sales were $0.2 million in the second quarter of 2020.

Additional clinics were enrolled in the Company’s Real World Data program.

The Company received regulatory approval for Dialysate Triferic in Chile in June 2020.

China’s National Medical Products Administration (NMPA) approved the protocol for a clinical trial of Triferic Dialysate, to be initiated by its licensee in China, Wanbang Biopharmaceutical, Co., Ltd.

With respect to the COVID-19 pandemic, the Company continues to implement appropriate precautions to reduce the risk of possible exposure by restricting employee travel, adopting new preventative safety measures within its manufacturing facilities, instituting a work-from-home policy for substantially all employees, excluding its 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 an increase in demand for its dialysis concentrates products, believed to be attributed to customers building safety stock and international demand. Additionally, we have experienced an impact in our sales and marketing efforts for Triferic Dialysate due to the restrictions put in place because of COVID-19. This caused us to change the way we interact with our current and potential customers. We intend to initiate a sample evaluation program for Triferic AVNU during the third quarter of 2020 in order to prepare for a commercial launch. We will monitor the evaluation program in relation to the COVID-19 pandemic through the balance of the year.

Triferic AVNU (I.V. Formulation)

The Company filed a New Drug Submission ("NDS") for Triferic AVNU in Canada in May 2020. Health Canada accepted the NDS in June 2020. The Company currently expects regulatory approval in mid-2021.

The Company continues to execute its 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 currently expects to launch evaluation programs during the third quarter of 2020 to allow clinics to gain direct experience with



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Triferic AVNU, and expects Triferic AVNU to be available commercially during the fourth quarter of 2020, following the completion of the initial evaluation programs.

New Indications for FPC

In the second quarter of 2020, based upon analysis of development considerations, economics, pricing, and regimen ergonomics, the Company identified two new potential indications for its Ferric Pyrophosphate Citrate ("FPC") platform:

FPC for the treatment of iron deficiency in patients requiring home infusion therapy, which the Company considers its first priority new indication to pursue; and

FPC to improve cardiac function in hospitalized acute congestive heart failure patients, which is under consideration by the Company.

The Company plans to host a Management and KOL update conference call and webcast on Thursday, September 24, 2020, to discuss further details of its plans to pursue new FPC indications. The Company will provide additional details on accessing the conference call and webcast in the near future.

Second Quarter 2020 Corporate Updates

In June 2020, the Board of Directors appointed industry leader and renowned authority on kidney disease, Allen R. Nissenson, M.D., F.A.C.P., to serve as a director. Dr. Nissenson serves as an Emeritus Professor of Medicine at the David Geffen School of Medicine at University California Los Angeles, Emeritus Chief Medical Officer of DaVita Kidney Care, and a member of the board of directors of Angion Biomedica Corp.

Second Quarter 2020 Selected Financial Highlights

The following discussion and analysis should be read in conjunction with our condensed consolidated financial statements and related notes on Form 10-Q for the second quarter ended June 30, 2020.

Net sales for the second quarter of 2020 were $15.9 million, an increase of 7.1% compared to net sales of $14.8 million for the second quarter of 2019. The increase was primarily due to an increased demand for our dialysis concentrates products. Triferic net sales for the three months ended June 30, 2020 was approximately $0.2 million. Triferic was launched in Q2 2019 via the sample evaluation program and there were nominal revenues for the same period in 2019.

Cost of sales for the second quarter of 2020 was $15.0 million, resulting in gross profit of $0.9 million, compared to cost of sales of $14.1 million and a gross profit of $0.7 million during the second quarter of 2019. Gross profits are primarily related to our Dialysis concentrates products at this time. The Company anticipates that potential future sales of Triferic will impact the mix on our future gross profits.



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Selling and marketing expenses were $2.0 million for the second quarter of 2020 compared to $2.2 million for the second quarter of 2019. The Company has invested in a specialty commercial team and marketing programs to support the launch of Triferic in Q2 of 2019 and the commercial introduction to Triferic AVNU.

General and administrative expenses were $2.9 million for the second quarter of 2020 compared to $5.5 million for the second quarter of 2019. The decrease of $2.6 million was primarily due to a decrease in incentive compensation from forfeited equity awards associated with the departure of our former President and Chief Executive Officer in April 2020, a decrease in legal expense relating to previous litigation that has since been resolved; partially offset by severance pay relating to the same former President and Chief Executive Officer.

Research and product development expenses were $1.6 million for the second quarter of 2020 compared to $3.0 million for the second quarter of 2019. The decrease of $1.4 million was due primarily to the payment for the Triferic AVNU NDA application fee of $1.3 million in Q2 2019. The Company is continuing to invest in its medical and scientific programs to support the global launch of Triferic and the advancement of our ferric pyrophosphate citrate technology platform.

Net loss for the second quarter of 2020 was $6.9 million, or $0.10 per basic and diluted share, compared to a net loss for first quarter of 2019 of $10.3 million, or $0.18 per basic and diluted share.

Cash, cash equivalents, and investments available-for-sale totaled $40.0 million as of June 30, 2020, compared to $48.9 million on March 31, 2020. Working capital was $40.0 million as of June 30, 2020 compared to $46.1 million as of March 31, 2020. Additionally, the Company has a debt facility of $35.0 million of which the first tranche of $22.5 million was funded in March 2020 and is classified as long-term debt on the balance sheet. The Company will be eligible to draw on a second and third tranche of $5.0 million and $7.5 million, respectively, upon achievement of certain milestones. Lastly, the Company has an at-the-market equity offering facility of $40.0 million of which approximately $32.6 million remains available for issuance 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.

As of June 30, 2020, there were 70,156,922 shares of common stock outstanding versus 69,049,102 shares outstanding as of March 31, 2020.

Second Quarter 2020 and Business Update Conference Call and Webcast

Rockwell Medical's management team will host a conference call and audio webcast today at 4:30 p.m. ET to discuss Q2 2020 financial results and provide a business update.

To access the conference call, please dial (877) 383-7438 (local) or (678) 894-3975 (international) at least 10 minutes prior to the start time and refer to conference ID 7990808. A live webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's



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website, https://ir.rockwellmed.com/. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.

About Rockwell Medical

Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company’s initial focus is the treatment of anemia in end-stage kidney disease (ESKD). Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.

About Triferic Dialysate and Triferic AVNU

Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment. Triferic Dialysate and Triferic AVNU have a unique and differentiated mechanism of action, which has the potential to benefit patients and health care economics. Triferic Dialysate and Triferic AVNU represent a potential innovative medical advancement in hemodialysis patient iron management - with the potential to become the future standard of care.

Triferic Dialysate and Triferic AVNU both deliver approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintain hemoglobin without increasing iron stores (ferritin). Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body) upon entry into the blood which is then transported directly to the bone marrow to be incorporated into hemoglobin, with no increase in ferritin (stored iron and inflammation) and no reports of anaphylaxis in over 1,000,000 patient administrations, addressing a significant medical need in overcoming Functional Iron Deficiency (FID) in ESKD patients.

Important Safety Information

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving Triferic in two randomized clinical trials.

Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.

The most common adverse reactions (≥3% and at least 1% greater than placebo) in controlled clinical studies include: procedural hypotension (21.6%), muscle spasms (9.6%), headache (9.2%),



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pain in extremity (6.8%), peripheral edema (6.8%), dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, the impact of COVID-19 on Rockwell Medical’s business and operations, the commercialization of Triferic Dialysate, the launch of Triferic AVNU, the selection of and plans for Rockwell Medical’s FPC pipeline candidates, the initiation of a clinical trial in China, the timeline for receipt of a target action date in Canada and the Company’s expected research and development expenses. Words such as, “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “can,” “would,” “develop,” “plan,” “potential,” “predict,” “forecast,” “project,” “intend” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical’s SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic (including, applicable federal state or local orders) on business and operating results, including our supply chain, dialysis concentrates business and the commercial launch of Triferic AVNU; the challenges inherent in new product development and other indications and therapeutics areas for our products; the success of our commercialization strategy; the success and timing of our commercialization of Triferic Dialysate; the success and timing of international clinical trials for Triferic Dialysate; the success and timing of our evaluation program for Triferic AVNU and our commercial launch of Triferic AVNU in the United States; the success and timing of the development of our FPB pipeline candidates, the risk that topline clinical data and real world results may not be predictive of future results; the anticipated number of future clinics with which we may contract for use of Triferic Dialysate; the expected number of annualized treatments for Triferic Dialysate; anticipated research and development expenses, expected financial performance, including cash flows, revenues, growth, margins, funding, liquidity and capital resources; and those risks more fully discussed in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the period ended June 30, 2020 and of our Annual Report on Form 10-K for the year ended December 31, 2019, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.

Triferic® is a registered trademark of Rockwell Medical, Inc. Triferic AVNU is pending with the U.S. Patent and Trademark Office. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.



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Financial Tables Follow



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ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited)
 
June 30, 2020
 
December 31, 2019
 
 
 
 
ASSETS
 
 
 
Cash and Cash Equivalents
$
26,697,063

 
$
11,794,526

Investments Available-for-Sale
13,258,197

 
14,250,176

Accounts Receivable, net
3,565,292

 
4,202,725

Inventory, net
4,557,177

 
3,646,906

Prepaid and Other Current Assets
3,458,104

 
2,979,504

Total Current Assets
51,535,833

 
36,873,837

Property and Equipment, net
2,306,462

 
2,433,405

Inventory, Non-Current
821,000

 
441,000

Right of Use Assets, net
2,440,115

 
3,212,530

Goodwill
920,745

 
920,745

Other Non-Current Assets
560,588

 
434,935

Total Assets
$
58,584,743

 
$
44,316,452

LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
 
Accounts Payable
$
3,313,240

 
$
3,018,424

Accrued Liabilities
4,437,080

 
4,517,732

Settlement Payable

 
104,000

Lease Liability - Current
1,342,228

 
1,493,394

Deferred License Revenue - Current
2,174,626

 
2,233,640

Insurance Financing Note Payable

 
763,422

Customer Deposits
38,273

 
55,100

Other Current Liability - Related Party
189,600

 
187,849

Total Current Liabilities
11,495,047

 
12,373,561

 
 
 
 
Lease Liability - Long-Term
1,204,210

 
1,780,626

Term Loan, Net of Issuance Costs
20,764,213

 

Deferred License Revenue - Long-Term
8,909,703

 
9,842,762

Total Liabilities
42,373,173

 
23,996,949

 
 
 
 
Stockholders’ Equity:
 
 
 
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; no shares issued and outstanding at June 30, 2020 and December 31, 2019

 

Common Stock, $0.0001 par value; 170,000,000 shares authorized; 70,156,922 and 65,378,890 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively
7,017

 
6,538

Additional Paid-in Capital
337,551,385

 
326,777,250

Accumulated Deficit
(321,392,548
)
 
(306,516,265
)
Accumulated Other Comprehensive Income
45,716

 
51,980

Total Stockholders’ Equity
16,211,570

 
20,319,503

Total Liabilities And Stockholders’ Equity
$
58,584,743

 
$
44,316,452






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ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(unaudited)
 
Three Months Ended March 31, 2020
 
Three Months Ended March 31, 2019
 
Six Months Ended June 30, 2020
 
Six Months Ended June 30, 2019
 
 
 
 
 
 
 
 
Net Sales
$
15,895,971

 
$
14,845,788

 
$
31,752,510

 
$
30,405,227

Cost of Sales
15,015,404

 
14,112,639

 
29,759,017

 
28,661,686

Gross Profit
880,567

 
733,149

 
1,993,493

 
1,743,541

Selling and Marketing
1,996,595

 
2,218,997

 
4,069,393

 
5,321,375

General and Administrative
2,871,013

 
5,496,670

 
8,144,445

 
11,717,169

Settlement Expense

 
430,000

 

 
430,000

Research and Product Development
1,616,393

 
2,958,276

 
3,437,881

 
3,455,552

Operating Loss
(5,603,434
)
 
(10,370,794
)
 
(13,658,226
)
 
(19,180,555
)
 
 
 
 
 
 
 
 
Other Income (Expense)
 
 
 
 
 
 
 
Realized Gain on Investments
2,065

 
4,135

 
3,994

 
18,023

Warrant Modification Expense
(837,322
)
 

 
(837,322
)
 

Interest Expense
(520,604
)
 

 
(622,556
)
 

Interest Income
66,750

 
74,476

 
237,827

 
192,002

Total Other Income
(1,289,111
)
 
78,611

 
(1,218,057
)
 
210,025

 
 
 
 
 
 
 
 
Net Loss
$
(6,892,545
)
 
$
(10,292,183
)
 
$
(14,876,283
)
 
$
(18,970,530
)
 
 
 
 
 
 
 
 
Basic and Diluted Net Loss per Share
$
(0.10
)
 
$
(0.18
)
 
$
(0.22
)
 
$
(0.33
)
Basic and Diluted Weighted Average Shares Outstanding
69,428,574

 
58,216,066

 
68,473,407

 
57,660,947

 
 
 
 
 
 
 
 


CONTACTS
Investors:
Argot Partners
212.600.1902
Rockwell@argotpartners.com

Media:
David Rosen
Argot Partners
212.600.1902
david.rosen@argotpartners.com


rmti2020q2earningsslided
Q2 2020 Financial Results and Business Update August 10, 2020 1


 
Call Participants Russell Ellison, M.D., M.Sc. President and Chief Executive Officer Tim Chole Vice President of Marketing Paul McGarry VP, Corporate Controller and Principal Accounting Officer Marc Hoffman, M.D. Chief Medical Officer 2


 
Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, the impact of COVID-19 on Rockwell Medical’s business and operations, the commercialization of Triferic Dialysate, the launch of Triferic AVNU, the selection of and plans for Rockwell Medical’s FPC pipeline candidates, the initiation of a clinical trial in China, the timeline for receipt of a target action date in Canada and the Company’s expected research and development expenses. Words such as, “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “can,” “would,” “develop,” “plan,” “potential,” “predict,” “forecast,” “project,” “intend” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical’s SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic (including, applicable federal state or local orders) on business and operating results, including our supply chain, dialysis concentrates business and the commercial launch of Triferic AVNU; the challenges inherent in new product development and other indications and therapeutics areas for our products; the success of our commercialization strategy; the success and timing of our commercialization of Triferic Dialysate; the success and timing of international clinical trials for Triferic Dialysate; the success and timing of our evaluation program for Triferic AVNU and our commercial launch of Triferic AVNU in the United States; the success and timing of the development of our FPB pipeline candidates, the risk that topline clinical data and real world results may not be predictive of future results; the anticipated number of future clinics with which we may contract for use of Triferic Dialysate; the expected number of annualized treatments for Triferic Dialysate; anticipated research and development expenses, expected financial performance, including cash flows, revenues, growth, margins, funding, liquidity and capital resources; and those risks more fully discussed in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the period ended June 30, 2020 and of our Annual Report on Form 10-K for the year ended December 31, 2019, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law. Triferic® is a registered trademark of Rockwell Medical, Inc. Triferic AVNU is pending with the U.S. Patent and Trademark Office. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement. 3


 
Today’s Call 1 Our Commitment to Hemodialysis 2 Triferic® Dialysate 3 Triferic® AVNUTM 4 New Indication Opportunities 5 Q2 Financial Update 6 Q&A 4


 
Our Mission and Vision Mission: Transform the treatment of iron deficiency and anemia around the world to improve outcomes for patients Continue to develop into a more medically- and scientifically-driven company Vision: Drive next phase of growth by leveraging the attributes of our ferric pyrophosphate citrate (FPC) technology: • Triferic®: drive adoption and product revenue for two FDA-approved Triferic products in hemodialysis • FPC Platform: strategically identify and pursue applications in other disease states 5


 
Our Commitment to the Hemodialysis Community Concentrates Business Triferic Platform • #2 supplier of dialysis concentrates products in • Two FDA-approved products: Triferic Dialysate the U.S. and Triferic AVNU • $60+ million of annualized sales • Only FDA-approved therapies indicated to • Facilitating nearly 20 million life-saving replace iron and maintain hemoglobin for treatments each year dialysis patients • Maintained supply and distribution chain • Unique mechanism of action throughout the COVID-19 pandemic • Immediate availability of iron to tissues • Safety profile comparable to placebo • Potential for new indications: – Iron deficiency anemia in the home parenteral infusion setting – Iron deficiency in hospitalized patients with acute congestive heart failure 6 6


 
COVID-19 Commentary • COVID-19 has had a unique impact on the dialysis community in the U.S. • Rockwell Medical stands with the dialysis community and we continue our efforts to maintain our high level of service – Employee safety initiatives – Enhanced sanitization protocols in manufacturing facilities – Close coordination with customers • Impact to Rockwell Medical: – No material impact on supply chain for concentrates or Triferic to date – Limitations have affected our Triferic field employees, although certain U.S. geographies have started to re-open – Continue to monitor potential impact of the pandemic on international clinical trial and regulatory timelines 7


 
Q2 2020 Highlights 8


 
Q2 2020 Highlights • Net sales were $15.9 million • Triferic net sales were $0.2 million and $0.5 million for the three and six months ended June 30, 2020 • Nearly 2,800 contracted patients on therapy for Triferic Dialysate, representing >400,000 annualized treatments • Signed contracts with 12 additional clinics, a 44% increase in contracted clinics compared to March 31, 2020 – Additional eight clinics affiliated with an MDO were trained and approved for adoption as of June 30, 2020 – Substantially all clinics contracted during Q2 converted in June • Active or committed Evaluation Programs with independent dialysis clinics and small dialysis chains representing 26 clinics and nearly 1,500 patients • Enrolled additional clinics in our Real World Data program • Appointed Dr. Allen Nissenson to the Board of Directors • NDS accepted by Health Canada for Triferic AVNU • Received regulatory approval for Dialysate Triferic in Chile in June 2020 9


 
Triferic® Dialysate Commercial Metrics 10


 
Summary of Key Metrics Metric 9/30/19 12/31/19 3/31/20 6/30/20 Contracted Patients on Therapy 1,000+ 1,650+ ~2,000 ~2,800 Contracted Annualized Treatment 150,000+ 250,000+ ~300,000 >400,000 U.S. Market Introduction Volume Evaluation Program Patients 1,300+ 600+ 2,250+ ~1,500 Evaluation Program Conversion Rate 75%+ 75% 75% ~75% Centers of Excellence 1 1 1 1 Medical Platform Centers Collecting and Reporting Data 7 8 12 14 KOL Advisory Relationships 10 10 11 13 11


 
Triferic: U.S. Market Introduction Contracted Clinics Evaluation Program Clinics 50 40 47 36 45 35 40 30 26 35 39 25 30 27 20 25 23 15 20 10 10 15 10 5 5 0 12/31/2019 3/31/2020 6/30/2020 0 12/31/2019 3/31/2020 6/30/2020 COVID-19 Impact* * Includes four clinics that were trained for administration and another four that were scheduled for administration training in March. 12


 
Triferic® AVNU 13


 
Triferic AVNU Quarterly Overview Expands U.S. access and provides more access to global markets heavily reliant on on-line bicarb generation • Triferic AVNU received FDA Approval on March 27, 2020 – 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 – Provides access to clinics utilizing dry bicarbonate systems: infused over 3hrs, or divided bolus dose, I.V. • Initiating customer outreach to increase awareness of Triferic AVNU – Reaching out to target customers using dry bicarbonate that have expressed interest in Triferic – Engaging with dialysis organizations that have existing purchase agreements in place for Triferic Dialysate – Preparing the promotional, communications, and education programs for the commercial launch • Currently manufacturing sample and commercial supply • Company expects to launch evaluation programs during Q3 2020 – Leverage success of the Triferic Dialysate Evaluation Program – Triferic AVNU commercial availability expected in the fourth quarter of 2020 following the completion of the initial evaluation programs 14


 
Real-World Data Update 15


 
Real-World Data: Overall Clinical Impact Additional data from USRDS on single clinic shows meaningful outcomes: Rates for all cause and infection-related hospitalization, and mortality for HHD patients, 2016-17* Infectious Deaths Year # of patient- Hospitalizations Inpatient days hospitalizations Infectious inpatient per 1,000 years (PY) at risk PPY PPY PPY days PPY PY Facility using Triferic on 1/1/2017 2016 49 2.85 21.7 0.49 3.86 101 2017 48 1.41 9.25 0.13 0.71 42.0 All Other US Dialysis Facilities 2016 427057 2.12 16.0 0.35 3.05 164 2017 436247 2.12 16.1 0.33 2.96 165 • A reduction of 17.7% and 45.5% in missed treatments for 5th and 6th quarters following Triferic introduction • Mortality rates reduced 58% • Infectious hospital admission reduced 73%; infection-related hospital days reduced 82% *Abstract submitted and under consideration for inclusion in ASN 2020 annual congress. 16


 
Preview of FPC New Indication Opportunities 17


 
1st priority: Home Infusion - Overview • Opportunity: I.V. administration of specialty drugs or nutrients in the home setting • Home and specialty infusion marketplace is experiencing explosive growth • Many patients treated with home infusion therapies suffer from iron deficiency anemia • Traditional I.V. iron is rarely administered at home due to safety concerns • FPC is uniquely suited for home infusion due to its excellent safety and tolerability profile and administration….and the clinical program could be rapid and relatively low cost Comparison of Home Infusion Therapy by Total Patients Served: U.S. patients undergoing the following daily home infusion therapies are known to have a high incidence of iron deficiency and/or iron deficiency 2010: 2019: anemia (30 – 60%): 829,000 3,224,427 Parenteral Nutrition 113,000 patients Hydration 160,000 patients Chemotherapy 132,000 patients Inotropic agents 86,000 patients 18


 
Home Infusion: 1st priority Favorable Market Access and Rapid, Low Cost Clinical Program Market access conditions for FPC as a home infusion therapy are favorable: • Almost 50% of home infusion therapy is reimbursed by commercial payers using a well-established universal approach • Medicare provides favorable coverage for specific eligible drugs through the Part B home infusion benefit* • Payers are increasingly motivated to reimburse home infusion therapy to limit in-office visits and hospitalizations and to reduce costs Clinical Program could be rapid and low cost: • Type C meeting with FDA in 2020 • Phase II studies, 2021: • Total cost: $1.5m-$2.5m • Estimated completion in 13-18 months • Phase III: $5m-$8m, approx. 2 years *Part B Durable Medical Equipment, Prosthetic, Orthotics, and Supplies Benefit 19


 
Under Consideration: Acute Heart Failure - Overview • Opportunity: Heart failure in the U.S. is a large and growing patient population • Prevalence of heart failure grew 6-fold from 2010 – 2018 (now 6.5m patients)1,2 • A significant number of patients are hospitalized each year with acute heart failure • 1.2m patients are hospitalized annually in the U.S. with acute systolic heart failure3 • Cost of 1-day hospitalization for AHF patient = $2,4444 • Re-admission within 30 days costs a hospital $13,4004 • Iron deficiency, independent of anemia, is a recognized complication that decreases cardiac performance • 55-85% of AHF patients are iron deficient5 • Multiple studies with traditional I.V. iron in heart failure outpatients show important clinical benefits • Utility of traditional I.V. iron therapy is limited for hospitalized patients due to safety concerns and delayed availability of iron • FPC may be uniquely suited for treatment of iron deficiency in hospitalized AHF patients • Phase II POC : cardiac bioenergetics study can be completed in 20-24 months: • Objective: Establish mechanistic proof of concept – FPC impact on heart energetics and function 1. https://www.cdc.gov/nchs/products/databriefs/db108.htm 2. https://www.cdc.gov/heartdisease/heart_failure.htm 3. MEDPAR & HCUP 4. www.hcupnet.ahrg.gov – HCUP National Inpatient Sample, 2016 Agency for Healthcare Research and Quality (AHRQ) 5. Enjuanes et al, Okonko et al, Cohen-Solal et al, Nunez et al, Van Aelst et al, multiple peer-reviewed publications on file (2011-2017) 20 20


 
Q2 2020 Financial Results 21


 
Q2 2020: Selected Balance Sheet and Cash Flow Metrics As of As of ($ in millions) 6/30/2020 12/31/2019 Cash, Cash Equivalents & Investments $ 40.0 $ 26.0 Long-Term Debt, net 20.8 - Working Capital 40.0 24.5 Q2 Q2 2020 2019 Cash Flow from Operations - YTD $ (16.2) $ (10.3) Total Change in Cash & Investments (8.9) 7.4 22


 
Q2 2020 : Selected Income Statement Metrics Q2 Q2 % ($ in millions) 2020 2019 Change Net Sales $ 15.9 $ 14.8 7.1% Triferic Net Sales 0.2 0.1 100 Gross Profit 0.9 0.7 20.1 Selling & Marketing Expenses 2.0 2.2 (10.0) General & Administrative Expenses 2.9 5.5 (47.8) Research & Product Development Expenses 1.6 3.0 (45.4) Operating Income (Loss) (5.6) (10.4) (46.0) Net Income (Loss) (6.9) (10.3) (33.0) 23


 
Triferic International Updates 24


 
Q&A 25