Rockwell Medical, Inc. Provides First Quarter 2020 Financial and Operational Update and Top-line Real-World Triferic Data
-Q1 2020 revenue of
-Received FDA Approval of Triferic® AVNUTM-
-Significant expansion of Triferic (ferric pyrophosphate citrate) Dialysate Evaluation Programs during Q1 2020-
-Retrospective real-world analysis over 18 months shows reduction in
-Strengthened financial position with
-Conference call and webcast scheduled for today at
“In my new role, my charge is to maximize the commercial potential of our two FDA-approved products, Triferic Dialysate and Triferic AVNU, while developing
First Quarter 2020 Operational Highlights
- 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.
- 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.
- Nearly 2,000 contracted patients on therapy as of
March 31, 2020, representing over 300,000 annualized treatments.
- Triferic net sales were
$0.3 millionin the first quarter of 2020.
- Entered into exclusive license and supply agreements with Sun Pharma for the rights to commercialize Triferic Dialysate in
India. Rockwell Medicalreceived an upfront fee and will be eligible for milestone payments and royalties on net sales.
- 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 Medicalin instances where other suppliers have not been able to meet demand.
Triferic AVNU (IV Formulation)
March 27, 2020, Rockwell Medicalannounced that the FDA approved its New Drug Application for Triferic AVNU, its intravenous formulation of Triferic.
- 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.
- 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.
Triferic Real-World Data
Today, the Company announced the top-line results from a retrospective analysis of Triferic Dialysate clinical use. The analysis included patient outcomes from an independent dialysis clinic with approximately 65 patients, from a baseline period of 3 months prior to the adoption of Triferic Dialysate through 18 months post-adoption.
“Today’s results, while a snapshot from a single clinic, demonstrate meaningful clinical and real-world trends observed following the adoption of Triferic Dialysate,” said
Findings from the analysis include:
- A more than 23% reduction in ESAs utilized per patient, per week during the sixth quarter after Triferic Dialysate administration vs. baseline.
- 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.
- Stable to increasing hemoglobin levels, with consistent hemoglobin control throughout the observation period.
- A meaningful reduction in missed treatments of nearly one-fifth and one-half for the 5th and 6th quarters, respectively.
- Improvements in key quality of life indicators as measured by KDQOLTM-36.
The Company is evaluating potential publication and/or presentation of the full results of the findings at a future medical meeting.
First Quarter 2020 Corporate Updates
- 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.
- The Company announced the appointment of
Robert S. Radieto its Board of Directors, effective March 31, 2020. Mr. Radiebrings 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.
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 millionin term loans. The first $22.5 milliontranche was funded on March 16, 2020. The Company will be eligible to draw on a second tranche of $5.0 millionfollowing the completion of certain milestones, which includes the FDA approval of Triferic AVNU, and a third tranche of $7.5 millionupon the achievement of certain additional milestones, including the achievement of certain Triferic sales thresholds.
- The Company completed the pricing of an underwritten public offering of the Company’s common stock in
February 2020for gross proceeds of approximately $8.1 million, before deducting issuance costs.
First Quarter 2020 Financial Results
Net sales for the first quarter of 2020 were
Cost of sales for the first quarter of 2020 was
Selling and marketing expenses were
General and administrative expenses were
Research and product development expenses were
Net loss for the first quarter of 2020 was
Cash, cash equivalents, and investments available-for-sale totaled
First Quarter 2020 and Business Update Conference Call and Webcast
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 9391556. A live webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's 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 Triferic Dialysate and Triferic AVNU
Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the
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 ESRD 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%), 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%).
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 commercialize Triferic Dialysate, and Triferic AVNU. 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
Triferic® is a registered trademark of
Financial Tables Follow
Condensed Consolidated Balance Sheets
|Cash and Cash Equivalents||$||37,399,801||$||11,794,526|
|Investments Available-for -Sale||11,456,285||14,250,176|
|Accounts Receivable, net||4,586,748||4,202,725|
|Prepaid and Other Current Assets||1,758,002||2,979,504|
|Total Current Assets||59,493,604||36,873,837|
|Property and Equipment, net||2,430,113||2,433,405|
|Right of Use Assets, net||2,797,759||3,212,530|
|Other Non-current Assets||560,588||434,935|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Lease Liability - Current||1,351,348||1,493,394|
|Deferred License Revenue - Current||2,179,383||2,233,640|
|Insurance Financing Note Payable||190,855||763,422|
|Other Current Liability -
|Total Current Liabilities||13,357,168||12,373,561|
|Lease Liability - Long-Term||1,559,749||1,780,626|
|Term Loan, Net of Issuance Costs||20,683,704||—|
|Deferred License Revenue - Long-Term||9,450,983||9,842,762|
|Additional paid-in capital||336,216,422||326,777,250|
|Accumulated Other Comprehensive Income||50,881||51,980|
|Total Stockholders’ Equity||21,774,205||20,319,503|
|Total Liabilities And Stockholders’ Equity||$||66,825,809||$||44,316,452|
Condensed Consolidated Statements of Operations
|Three Months Ended
||Three Months Ended
|Cost of Sales||14,743,613||14,549,047|
|Selling and Marketing||2,072,798||3,102,378|
|General and Administrative||5,273,433||6,220,499|
|Research and Product Development||1,821,488||497,276|
|Other Income (Expense)|
|Realized Gain on Investments||1,929||13,888|
|Total Other Income||71,055||131,414|
|Basic and Diluted Net Loss per Share||$||(0.12||)||$||(0.15||)|
|Basic and Diluted Weighted Average Shares Outstanding||67,518,240||57,098,947|
Source: Rockwell Medical, Inc.