FDA sets PDUFA Date for I.V. Triferic Drug on March 28, 2020

As the current healthcare crisis rages on, millions of patients for other conditions still require the attention and innovation of professionals in the space to come to their aid.

While there are calls from leaders to fast-track drug approvals¹ to mitigate the crisis, organizations such as the US Food and Drug Administration (FDA) still have potential drugs for other deadly conditions in need of review.

One new drug could potentially come as a relief to more than a billion people worldwide… VERY soon.

After going through all the necessary lead-up phases for FDA approval², the drug’s future is hinged on what’s known as the ever-important PDUFA date³.

For this particular drug, that PDUFA date is ever so near…. March 28th, to be exact.

So… MARK YOUR CALENDARS, because that date could be the breakthrough for Rockwell Medical Inc. (NASDAQ:RMTI) that investors have been looking for. The company generated $61.3 million in revenue in FY 2019 and with the potential for the next approval so close, 2020 could turn out to be a fantastic year for the company.

This drug is named I.V. TRIFERIC®is attempting to tackle a very serious condition that the CDC acknowledges was the cause of 5,382 deaths (1.7 people per 100,000 population) in 2017.⁴

The condition is… anemia.

It’s an iron deficiency disorder—often associated with diabetes mellitus or Type 2—that affects more than 2.8 million Americans1 and over 1.62 billion people worldwide⁵.

And with the growing prevalence of diabetes, which is projected to increase by 54% to more than 54.9 million Americans between 2015 and 2030, and increased societal costs related to the disease to increase at roughly the same rate to more than $622 billion by 2030⁶… this new drug if approved is clearly very needed.

It’s time to take an in-depth look at a company possibly on the cusp of a major drug approval, that’s here to protect those with anemia and kidney disease.

Rockwell Medical Inc. (NASDAQ:RMTI)

Meet Rockwell Medical Inc. (NASDAQ:RMTI) a commercial-stage company with a platform drug technology designed to transform anemia management in a wide variety of disease states across the globe, with an initial focus on ESRD.

Their drug, TRIFERIC, is now before the FDA in the final days ticking down to its PDUFA date of March 28, 2020… the result of which could make or break the company.

Recent activities from the company show that they’re poised to roll with the platform, including having secured a war chest of $35 Million in debt financing, and a MASSIVE partnership with a +$11-Billion company for the rights to commercialize TRIFERIC in India.

The Rockwell Medical Inc. (NASDAQ:RMTI) team consists of winners from within the pharmaceutical sector, including a President and CEO who served as Corporate Officer and VP of Abbott Laboratories, leading its largest global business unit with $600 million of revenues.

Now it’s the potential for Rockwell Medical through Triferic to capture market potential in excess of $1 billion. This potential has not been ignored by the analysts currently covering and targeting Rockwell Medical Inc. (NASDAQ:RMTI).

Rockwell’s analyst coverage has been very favorable:

• IFS SECURITIES – STRONG BUY
• PIPER SANDLER – STRONG BUY
• H C Wainwright – STRONG BUY

The potential for upside if the drug is approved this week could be massive.

CLOCK TICKING ON THE PDUFA DATE

In August 2019, Rockwell Medical Inc. (NASDAQ:RMTI) announced that the US Food and Drug Administration (FDA) had accepted the company’s New Drug Application (NDA) for its Intravenous formulation of TRIFERIC with a PDUFA (Prescription Drug User Fee Act) date of March 28, 2020⁸.

It’s actually quite rare for new drugs to get to this stage of the approval process. Only a select few per year are even deemed eligible for this level approval.

If a company gets its breakthrough drug FDA approved, its stock typically is likely to climb as a result.

Knowing that a PDUFA date is imminent can give investors an edge and help them time their upcoming stock purchases.

STANDOUT COMMERCIAL-STAGE BIOTECH PLAY

What must be taken into account, is that Rockwell Medical Inc. (NASDAQ:RMTI) is already a commercial-stage company, with a platform technology that’s designed to transform anemia management as we know it—with the initial focus on end-stage renal disease (ESRD).

Through its flagship proprietary platform TRIFERIC, Rockwell Medical has already launched into sales and distribution in the USA, in May 2019 with revenues exceeding $61.3 million in FY 2019.

Over this campaign, the company has been collecting real-world data from seven sites totaling 500+ patients—the initial data readout is expected to be delivered in Q1 2020.

For new clinics (clients), that Rockwell Medical Inc. (NASDAQ:RMTI) has launched a 3-month Evaluation Program, which has already resulted in a 75% conversion rate since launch.

FIRST and ONLY FDA-APPROVED PRODUCT

TRIFERIC is one of the most innovative advancements in iron management over the last two decades.

It’s a novel therapy that addresses the daily iron needs of dialysis patients and avoids iron toxicity.

To date, it’s the FIRST and ONLY FDA-approved product indicated to maintain hemoglobin in HD-dependent CKD patients.

The company’s global intellectual property portfolio includes an Orange Book listed patent with expiry in 2029.

Rockwell Medical Inc. (NASDAQ:RMTI) has developed two formulations: Dialysate Triferic – launched May 2019: and I.V. Triferic – PDUFA date: March 28, 2020

The platform replaces recurring iron loss during dialysis, and maintains hemoglobin without increasing ferritin levels.

It’s a unique, physiologic mechanism of action that donates iron directly to transferrin for red blood cell production mimicking the body’s natural process of iron absorption.

What makes TRIFERIC different from traditional I.V. iron?

• • It’s taken up by reticuloendothelial cells first
  • Induces increase in ferritin and hepcidin levels
  • High ferritin and hepcidin levels increase iron storage and reduce iron uptake by transferring -> less efficient RBC production
  • Side effects may include: oxidative stress, iron overload, infection and cardiovascular disease

 MAMMOTH SIZED MARKET POTENTIAL

The opportunity that Rockwell Medical Inc. (NASDAQ:RMTI) has targeted is substantial. There are over two million people worldwide who receive hemodialysis annually.⁹

This equates to +250 million estimated annual hemodialysis treatments, with growth occurring due to increased rates of diabetes, obesity, and hypertension.

Once they’ve started, patients typically require dialysis for life, at a rate of at least 3x weekly.

The overall hemodialysis and peritoneal dialysis market is projected to reach US$99.2 billion by 2024—up from US$74.2 billion in 2019, at a CAGR of 6.0%.¹⁰

As early as 2015, Rockwell Medical Inc. (NASDAQ:RMTI) projected the global market potential for TRIFERIC to be in excess of $1 billion.¹¹

And in May of 2019, that’s when the company started sales of its TRIFERIC platform.

Positive Comparables

By looking at the other comparables in the space, it’s worth noting that the market is currently giving Rockwell Medical Inc. (NASDAQ:RMTI) the lowest market cap valuation vs revenue.

Within the USA, Rockwell Medical observed a TRIFERIC US Market Overview, that includes more than $4 billion spent on anemia management therapies annually in a concentrated provider market.¹⁷

TOP-TIER RELATIONSHIPS WITH LEADING DIALYSIS PLAYERS

Rockwell Medical Inc. (NASDAQ:RMTI) is the #2 supplier of dialysis concentrates in the US; relationships with leading dialysis players.

And earlier this year in January, the company secured a MASSIVE deal with a wholly-owned subsidiary of +$11-Billion pharma giant Sun Pharmaceutical Industries Ltd.—the largest pharmaceutical company in India, with more than $4 billion in annual sales globally.

Sun Pharma will leverage its market leading nephrology franchise to promote TRIFERIC to nephrologists in India.

Domestically, back home in the USA, the upcoming FDA PDUFA date decision could lead to a similarly large partner (or partners) wanting a piece of the action.

TRIFERIC is the FIRST and ONLY FDA-approved therapy indicated to replace iron and maintain hemoglobin levels in adult hemodialysis patients, and it already generates +$60M revenue annually.

The biggest players have already realized the potential of the TRIFERIC platform.

The company is now building upon its long-established existing relationships with other leaders in dialysis… namely Baxter, DaVita.

Backed by the experience of manufacturing and selling dialysis concentrates since the 1990s, Rockwell Medical Inc. (NASDAQ:RMTI) has a stepwise plan to establish TRIFERIC as the new standard of care.

Now with a newly minted cash supply of $35 million in funding on hand, through a debt financing agreement with Innovatus Capital Partners, the company is in a fantastic position moving forward.

“We are pleased to partner with Innovatus on this transaction. This financing will provide flexibility as we continue our mission to advance our novel therapeutic, TRIFERIC, and to transform the way anemia is managed around the world.”

– Stuart Paul, President and Chief Executive Officer of Rockwell Medical

Stacked Management Team with Deep Renal and Pharma Commercial Experience

Stuart Paul – President and CEOStuart Paul has +25 years of healthcare industry operating experience, with a successful track record of executing commercialization strategies both domestically and internationally. Previously, Stuart served as Corporate Officer and VP of Abbott Laboratories, leading its largest global business unit with $600 million of revenues. Prior to that, he served as the VP and General Manager of Quest Diagnostics’ U.S. East Region, and worked within private equity at Gambro AB, where he was responsible for leading and profitably expanding a variety of businesses.

Angus Smith – Chief Financial OfficerAngus Smith is a seasoned professional with expertise in debt and equity financings, mergers and acquisitions, licensing agreements, joint ventures and strategic partnerships. He oversees all financial operations and investor relations for the company. Prior to joining Rockwell, he most recently served as Senior Vice President, Chief Business Officer and Principal Financial Officer for Pernix Therapeutics, and prior to that as both their VP of Business Development and Strategic Planning, and VP of M&A and Corporate Finance.

Marc Hoffman, M.D. – Chief Medical OfficerDr. Hoffman has extensive experience in global drug development, medical affairs, pharmacovigilance and regulatory affairs, and has a proven track record in building, managing and globalizing medical teams for pharmaceutical companies; through both in-house roles at companies such as Baxter and Hospira and in senior leadership positions at various global contract research organizations (CROs), including Covance and, Parexel.

Ajay Gupta, M.D. – Chief Scientific OfficerPrior to serving as Rockwell’s Chief Scientific Officer Dr. Gupta was an Associate Professor of Medicine at UCLA and Charles Drew University Schools of Medicine. He’s the inventor of several patents for drugs, medical devices, methods and diagnostic tests, including delivering soluble ferric pyrophosphate parenterally including by slow continuous intravenous infusion, via the dialysate in hemodialysis and peritoneal dialysis patients, and as an additive to parenteral nutrition admixtures.

Ray Pratt, M.D. – Chief Development OfficerDr. Pratt has managed 10 different drugs through all stages of global development for renal and other indications, bringing extensive experience appearing before the FDA. Prior to serving as Rockwell Medical’s Chief Development Officer, he worked at Shire, serving as VP of R&D, Scientific Leader of Emerging Business and Renal Business Units, VP of Global Clinical Medicine and Global Clinical Affairs and Head of U.S. Clinical Development. While at Shire, he was instrumental in the FDA approval of Fosrenol ESRD indication and CKD non-dialysis indication in the European Union and United States

Jim McCarthy – Senior VP of Business and Corporate DevelopmentSeasoned business development executive Jim McCarthy has +30 years of life sciences industry experience, including a 25-year career with Bristol-Myers Squibb. He’s served in numerous roles assisting life science companies in a wide-range of therapeutic areas with strategic and commercial planning, venture financing, commercial initiatives and deal support on a global basis. In addition, he has significant domestic and international corporate business development experience and has executed a broad range of transactions including licensing deals, strategic alliances and acquisitions.

Anne Boardman – VP of Sales and Strategic AccountsAnne Boardman’s experience includes +30 years in renal, biotech and medical sales, sales management and large corporate account management. Additionally, she has significant experience in the renal space, with a strong understanding of the renal provider and reimbursement landscape. Previously, she served as Director of Integrated Health Systems at Baxter Healthcare and Vice President of Strategic Accounts at Gambro AB. Earlier in her career, she worked at a variety of specialty pharmaceutical and healthcare companies including Genzyme Therapeutics, OrthoBiotech and Watson Nephrology.

Michael DeYoun – VP of OperationsMichael DeYoung oversees Rockwell’s manufacturing operations, logistics and company-wide strategy deployment, specifically for the launch of Triferic® in the U.S. and globally. He brings +25 years’ experience in operations and finance, including roles as CFO of ZDHF Holdings, Group Director of Moog Medical Device Group. At Gambro AB, he contributed to the company’s successful exit and sale, led operational initiatives, and was responsible for the full integration of the company’s renal operations in Latin America.

—

Rockwell Medical Inc. (NASDAQ:RMTI) is a biopharmaceutical company dedicated to transforming 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 renal disease (ESRD). Rockwell Medical’s exclusive renal drug therapy, Triferic (ferric pyrophosphate citrate), is the only FDA-approved therapeutic 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.

9 Reasons
to Examine Rockwell Medical Inc. (NASDAQ:RMTI)

1

FDA Approval in final stage with PDUFA Date of March 28th:

presenting a rare moment in the sector of a company getting an official yes or no on their drug I.V. TRIFERIC®.

2

Commercial-stage company

with platform technology extremely close to potential approval that’s designed to transform anemia management across the globe.

3TRIFERIC is one of the most innovative advancements in iron management over the last two decades, and is the FIRST and ONLY FDA-approved product indicated to maintain hemoglobin in HD-dependent CKD patients.

4

Global TRIFERIC market has massive potential:

with a growing number of diabetes patients worldwide, set to reach nearly 55 million people by 2030 in the US alone.

5

Major exclusive license and supply agreement:

in India secured with the country’s largest pharmaceutical company with a market cap worth more than $11 billion.

6

Recent $35M debt financing

has the company well-equipped with a suitable war chest, in order to pursue the next stages of the TRIFERIC story.

7Company’s global intellectual property portfolio includes Orange Book listed patent with expiry in 2029.

8

#2 supplier of dialysis concentrates in the US;

relationships with leading dialysis players, generating $61M+ revenue annually.

9

Stellar management,

board and advisors with deep renal and pharma commercial experience.

___________________________________

1 https://cheddar.com/media/trump-pushes-fda-to-fast-track-antiviral-therapy-best-known-for-treating-malaria
2 https://www.drugs.com/fda-approval-process.html
3 https://www.fool.com/knowledge-center/what-is-a-pdufa-date.aspx
4 https://www.cdc.gov/nchs/fastats/anemia.htm
5 https://www.who.int/vmnis/anaemia/prevalence/summary/anaemia_data_status_t2/en/
6 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278808/
7 https://www.globenewswire.com/news-release/2019/08/06/1897380/0/en/Rockwell-Medical-Inc-Announces-Acceptance-by-FDA-of-New-Drug-Application-for-I-V-TRIFERIC.html
8 https://www.globenewswire.com/news-release/2019/08/06/1897380/0/en/Rockwell-Medical-Inc-Announces-Acceptance-by-FDA-of-New-Drug-Application-for-I-V-TRIFERIC.html
9 For selected countries listed in United States Renal Data System 2018 Annual Data Report. Table N.7.a “Yearly counts of all patients treated with in-center hemodialysis as of the end of the calendar year, 2003-2016.” and European Renal Association.
10 https://www.globenewswire.com/news-release/2020/01/21/1973338/0/en/The-hemodialysis-and-peritoneal-dialysis-market-is-projected-to-reach-USD-99-2-billion-by-2024-from-USD-74-2-billion-in-2019-at-a-CAGR-of-6-0.html
11 https://www.macrotrends.net/stocks/charts/RMTI/rockwell-medical/revenue
12 https://www.timesunion.com/business/article/FibroGen-4Q-Earnings-Snapshot-15099541.php
13 https://craft.co/acceleron-pharma
14 https://www.reuters.com/article/us-astrazeneca-revenue/drugmaker-astrazeneca-forecasts-faster-return-to-growth-idUSBREA0D0E620140114
15 https://www.gsk.com/en-gb/media/press-releases/gsk-delivers-2019-sales-of-338-billion-plus10-aer-plus8-cer-pro-forma-plus4-cerstar/
16 http://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2019-financial
17 Nephrology News and Issues, September 2018, Mark E Newman, Table 1: The largest dialysis providers in 2018.

Rockwell Medical Inc. (RMTI)

$ 2.11-0.10 | -4.52%R

Bid: 2.11 x 300Ask: 2.17 x 400

March 20, 2020 4:00 PMEDTVolume: 1,645,767

After Hours: $ 2.11  0.00 | 0.00%March 20, 2020 7:59 PMEDTVolume: 3,504

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