Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the
“Company”), a biopharmaceutical company dedicated to improving
outcomes for patients with anemia, with an initial focus on
end-stage renal disease (ESRD), today reported business highlights
and financial results for the three- and nine-months ended
September 30, 2019.
“Our mission is to transform anemia management
in a wide variety of disease states across the globe while
improving patients’ lives. We believe Triferic is one of the most
innovative advancements in patient iron management over the last
two decades. Accordingly, we are building the foundation to become
a leading medical and commercial organization in the field of
dialysis, which we believe will enable Triferic to become, over
time, the standard of care for ESRD patients. We are pleased with
the early progress we are making with the commercialization of our
Triferic portfolio,” stated Stuart Paul, President and Chief
Executive Officer of Rockwell Medical.
Recent Business and Financial
Highlights:
- Key highlights for the Dialysate
Triferic U.S. market introduction include:○ 1,000+ patients
on therapy at 13 contracted clinics as of September 30,
2019;○ 1,300+ patients on therapy at 15 clinics enrolled in
the Evaluation Program;○ Since launch, experienced 75%
conversion rate of clinics in Evaluation Program; and○ The
Company entered into its first contract with a Center of
Excellence1 (“COE”) for the purchase of Dialysate Triferic.
- Appointed industry veteran John P.
McLaughlin as Chairman of the Board of Directors, bringing over 30
years of executive and board experience in the biopharmaceutical
industry;
- Continued to engage with the U.S.
Food and Drug Administration (“FDA”) on review activities regarding
the I.V. Triferic New Drug Application (“NDA”), with a PDUFA date
of March 28, 2020;
- Committed to enhancing the
Company’s medical capabilities to build a leading medical platform
in the field of dialysis;
- Sales were $15.4 million and $45.8
million for the three and nine months ended September 30, 2019,
respectively, including sales of Dialysate Triferic of
approximately $98,000 and $112,000, respectively; and
- As of September 30, 2019, the
Company had approximately $29.0 million of cash and cash
equivalents and investments available-for-sale.
“We recognize that transforming to a new therapy
from a well-entrenched approach takes time. As we build the
foundation to achieve our mission, both in the U.S. and
internationally, we are off to a promising start, and will continue
to dedicate our resources to ensuring that hemodialysis patients
have access to this innovative therapeutic,” concluded Paul.
_____________________________1 The Company
defines Centers of Excellence as leading independent academic
institutions that operate their own clinics or leading nephrology
practices that are recognized as thought leaders in dialysis.
Third Quarter 2019 Financial
Results
Net loss for the third quarter of 2019 was $7.9
million, or $0.12 per basic and diluted share, compared to a net
loss of $5.0 million, or $0.10 per basic and diluted share, in the
third quarter of 2018. The increase in net loss for the third
quarter of 2019 compared to the third quarter of 2018 primarily
reflects investments in the Company’s medical and commercial
platform in the field of dialysis to support the commercialization
and continued development of Triferic as Rockwell Medical executes
on its business plans.
Net sales for the third quarter of 2019 were
$15.4 million compared to sales of $16.7 million during the three
months ended September 30, 2018. Net sales of hemodialysis
concentrates to dialysis providers and distributors in the U.S. and
abroad were $15.2 million for the three months ended September 30,
2019 compared to $16.6 million for the three months ended September
30, 2018. The decrease of $1.4 million was primarily due to lower
sales to international customers, offset by an increase in sales
pursuant to the Company’s contract with DaVita Inc. Net sales
of Triferic were $166,000 for the three months ended September 30,
2019 compared to $68,000 for the three months ended September 30,
2018. For each of the three months ended September 30, 2019 and
September 30, 2018, Triferic net sales included approximately
$68,000 of deferred revenue recognized under the Company’s license
in the People’s Republic of China with Wanbang Biopharmaceutical.
Triferic net sales for the three months ended September 30, 2019
also included approximately $98,000 of Triferic product sales to
U.S. customers.
Cost of sales during the three months ended
September 30, 2019 was $15.4 million compared to cost of sales of a
$14.7 million during the three months ended September 30, 2018.
Cost of sales for the three months ended September 30, 2019
included $14.3 million of manufacturing and distribution costs
associated with the Company’s concentrates products, and $1.1
million of inventory reserve expenses and product costs for
Triferic, compared to $14.6 million and $0.1 million, respectively,
for the three months ended September 30, 2018. Gross loss for the
three months ended September 30, 2019 was approximately $16,000
compared to gross profit of $2.0 million for the three months ended
September 30, 2018. Gross profit (loss) for the three months ended
September 30, 2019 consisted of a gross loss from Triferic of $0.9
million, partially offset by gross profit of $0.9 million for the
Company’s concentrates products, compared to a gross loss of $0.1
million and gross profit of $2.0 million, respectively, for the
three months ended September 30, 2018.
Selling and marketing expenses were $1.8 million
during the three months ended September 30, 2019 compared with $0.1
million during the three months ended September 30, 2018. The
increase of $1.7 million was due to investments the Company is
making in developing a commercial platform to support the
commercial launch of Triferic.
General and administrative expenses were $4.6
million during the three months ended September 30, 2019 compared
with $6.0 million during the three months ended September 30, 2018.
The decrease of $1.4 million is primarily due to a decrease in
legal and related costs associated with various matters, including
litigation activities, related to the departure of certain
executives and directors during 2018, partially offset by increases
in insurance premiums.
Research and product development expenses were
$1.5 million for the three months ended September 30, 2019 compared
with $0.8 million during the three months ended September 30, 2018.
The increase was due to the Company’s commitment to investing in
and building the medical capabilities mentioned above, including
generating data from studies and real-world use of Triferic to
support medical education and development efforts, as well as the
expansion of the Company’s internal medical affairs staff. The
Company expects its research and product development expenses to
increase in the future due to additional clinical development of
Dialysate and I.V. Triferic, including the pediatric clinical trial
for Triferic, expenses associated with real-world data collection
and analysis for Triferic, and an increase in headcount to support
medical education efforts for Triferic.
Other income for the three months ended
September 30, 2019 was $0.1 million, consisting primarily of
interest income. Other income for the three months ended September
30, 2018 was approximately $29,000, consisting of $0.13 million of
interest income, offset by $0.1 million of realized gains on
investments.
The Company encourages shareholders to also
review its Form 10-Q for the quarter ended September 30, 2019, as
filed by the Company with the United States Securities and Exchange
Commission (“SEC”).
Conference Call
As previously announced, Rockwell Medical management will host
its third quarter 2019 conference call as follows:
Date |
Monday, November 11, 2019 |
Time |
4:30 PM EST |
Telephone |
|
U.S: |
|
(877) 383-7438 |
|
|
International: |
|
(678) 894-3975 |
Webcast (live and archive) |
https://edge.media-server.com/mmc/p/kxajr6w6 |
|
|
About Rockwell Medical Rockwell Medical is a
biopharmaceutical company dedicated to improving outcomes for
patients with anemia, with an initial focus on end-stage renal
disease (ESRD). Rockwell Medical's exclusive renal drug therapy,
Triferic, supports disease management initiatives to improve the
quality of life and care of dialysis patients and is intended to
deliver safe and effective therapy, while decreasing drug
administration costs and improving patient convenience. The Company
has developed multiple formulations of Triferic: (1) Dialysate
Triferic; and (2) I.V. Triferic. Dialysate Triferic is the only
FDA-approved therapeutic indicated for iron replacement and
maintenance of hemoglobin in hemodialysis patients. The Company’s
strategy is to bring its therapeutics to market in the United
States and to utilize partners to develop and commercialize such
therapeutics in international markets. 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. Please visit
www.rockwellmed.com for more information.
About Triferic Triferic is the only
FDA-approved therapy indicated to replace iron and maintain
hemoglobin in hemodialysis patients via dialysate during each
dialysis treatment. Triferic delivers approximately 5-7 mg iron
with every hemodialysis treatment to the bone marrow and maintains
hemoglobin without increasing iron stores (ferritin). Unlike
traditional IV iron products, Triferic donates iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood and 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. The Company has developed multiple formulations of
Triferic: (1) FDA-approved Dialysate Triferic; and (2) I.V.
Triferic, for which the Company filed a New Drug Application in May
2019 with a PDUFA date of March 28, 2020. Please visit
www.triferic.com to view the Triferic mode-of-action (MOA) video
and for more information.
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%).
For more information, including full prescribing information,
visit: http://www.triferic.com.
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, 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 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: statements about the issuance of a
unique J code for our Triferic Powder Packet; timing and regulatory
approval process for Dialysate Triferic in China; timing and
regulatory approval process of our NDA filing for I.V. Triferic as
filed with the FDA; the potential market opportunity and
commercialization of Dialysate Triferic in China; potential market
opportunity for I.V. Triferic, as well as other Rockwell Medical
products; pricing and reimbursement status for I.V. Triferic and
other Rockwell Medical products, CMS’ recently announced final rule
regarding eligibility for TDAPA; liquidity and capital resources;
expected duration of Rockwell Medical's existing working capital;
the progress and success with regard to our recently announced
commercialization of Dialysate Triferic; and timing and success of
our efforts to maintain, grow and improve the profit margin of the
Company’s concentrate business. Rockwell Medical expressly
disclaims any obligation to update or alter any statements whether
as a result of new information, future events or otherwise, except
as required by law.
Triferic® is a registered trademark of Rockwell Medical,
Inc.
Contact Investor Relations: Lisa M. Wilson,
In-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
Source: Rockwell Medical, Inc.
Financial Tables Follow
|
ROCKWELL
MEDICAL, INC. AND SUBSIDIARIES |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
|
September
30, |
|
December
31, |
|
|
2019 |
|
2018 |
|
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
Cash and Cash Equivalents |
|
$ |
14,421,394 |
|
|
$ |
22,713,980 |
|
Investments
Available-for -Sale |
|
|
14,575,589 |
|
|
|
10,818,059 |
|
Accounts
Receivable, net |
|
|
5,122,453 |
|
|
|
6,979,514 |
|
Insurance
Receivable |
|
|
— |
|
|
|
371,217 |
|
Inventory |
|
|
3,583,452 |
|
|
|
4,038,778 |
|
Prepaid and
Other Current Assets |
|
|
2,861,708 |
|
|
|
1,903,682 |
|
Total Current Assets |
|
|
40,564,596 |
|
|
|
46,825,230 |
|
Property and
Equipment, net |
|
|
2,506,093 |
|
|
|
2,638,293 |
|
Inventory,
Non-Current |
|
|
528,000 |
|
|
|
1,637,000 |
|
Right of Use
Assets, net |
|
|
3,011,805 |
|
|
|
— |
|
Goodwill |
|
|
920,745 |
|
|
|
920,745 |
|
Other
Non-current Assets |
|
|
555,933 |
|
|
|
536,516 |
|
Total Assets |
|
$ |
48,087,172 |
|
|
$ |
52,557,784 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
Accounts
Payable |
|
$ |
3,194,039 |
|
|
$ |
4,492,071 |
|
Accrued
Liabilities |
|
|
3,916,069 |
|
|
|
5,129,761 |
|
Settlement
Payable |
|
|
270,000 |
|
|
|
416,668 |
|
Lease
Liability - Current |
|
|
1,482,441 |
|
|
|
— |
|
Deferred
License Revenue - Current |
|
|
2,238,450 |
|
|
|
2,252,868 |
|
Insurance
Financing Note Payable |
|
|
1,145,133 |
|
|
|
— |
|
Customer
Deposits |
|
|
48,163 |
|
|
|
63,143 |
|
Other
Current Liability - Related Party |
|
|
100,000 |
|
|
|
850,000 |
|
Total Current Liabilities |
|
|
12,394,295 |
|
|
|
13,204,511 |
|
|
|
|
|
|
|
|
Lease
Liability - Long-Term |
|
|
1,589,098 |
|
|
|
— |
|
Deferred
License Revenue - Long-Term |
|
|
10,401,166 |
|
|
|
12,076,399 |
|
Total Liabilities |
|
|
24,384,559 |
|
|
|
25,280,910 |
|
|
|
|
|
|
|
|
Shareholders’ Equity: |
|
|
|
|
|
|
Preferred
Shares, $.0001 par value, no shares issued and outstanding at
September 30, 2019and December 31, 2018 |
|
|
— |
|
|
|
— |
|
Common
Shares, $.0001 par value; 170,000,000 shares authorized; 63,887,384
and 57,034,154 shares issued and outstanding at September 30, 2019
and December 31, 2018, respectively |
|
|
6,389 |
|
|
|
5,703 |
|
Additional
paid-in capital |
|
|
322,837,353 |
|
|
|
299,596,257 |
|
Accumulated
Deficit |
|
|
(299,213,836 |
) |
|
|
(272,388,234 |
) |
Accumulated
Other Comprehensive Income |
|
|
72,707 |
|
|
|
63,148 |
|
Total Shareholders’ Equity |
|
|
23,702,613 |
|
|
|
27,276,874 |
|
Total Liabilities And Shareholders’ Equity |
|
$ |
48,087,172 |
|
|
$ |
52,557,784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ROCKWELL
MEDICAL, INC. AND SUBSIDIARIES |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember 30,
2019 |
|
Three Months EndedSeptember 30,
2018 |
|
Nine Months EndedSeptember 30,
2019 |
|
Nine Months EndedSeptember 30,
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales |
|
$ |
15,407,248 |
|
|
$ |
16,672,416 |
|
|
$ |
45,812,475 |
|
|
$ |
46,534,358 |
|
Cost of
Sales |
|
|
15,423,612 |
|
|
|
14,703,606 |
|
|
|
44,085,298 |
|
|
|
49,303,048 |
|
Gross Profit (Loss) |
|
|
(16,364 |
) |
|
|
1,968,810 |
|
|
|
1,727,177 |
|
|
|
(2,768,690 |
) |
Selling and
Marketing |
|
|
1,827,473 |
|
|
|
121,874 |
|
|
|
7,148,848 |
|
|
|
716,414 |
|
General and
Administrative |
|
|
4,623,503 |
|
|
|
6,037,267 |
|
|
|
16,340,672 |
|
|
|
14,465,634 |
|
Settlement
Expense |
|
|
— |
|
|
|
— |
|
|
|
430,000 |
|
|
|
1,030,000 |
|
Research and
Product Development |
|
|
1,474,735 |
|
|
|
808,192 |
|
|
|
4,930,287 |
|
|
|
4,033,494 |
|
Operating Loss |
|
|
(7,942,075 |
) |
|
|
(4,998,523 |
) |
|
|
(27,122,630 |
) |
|
|
(23,014,232 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income |
|
|
|
|
|
|
|
|
|
|
|
|
Realized
Gain (Loss) on Investments |
|
|
6,268 |
|
|
|
(97,027 |
) |
|
|
24,292 |
|
|
|
(222,014 |
) |
Interest
Income, net |
|
|
80,735 |
|
|
|
125,918 |
|
|
|
272,736 |
|
|
|
486,301 |
|
Total Other Income |
|
|
87,003 |
|
|
|
28,891 |
|
|
|
297,028 |
|
|
|
264,287 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(7,855,072 |
) |
|
$ |
(4,969,632 |
) |
|
$ |
(26,825,602 |
) |
|
$ |
(22,749,945 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Loss per Share |
|
$ |
(0.12 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.45 |
) |
|
$ |
(0.44 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Weighted Average
SharesOutstanding |
|
|
63,796,723 |
|
|
|
51,288,537 |
|
|
|
59,728,446 |
|
|
|
51,288,462 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Apr 2023 to Apr 2024