Form 8-K ROCKWELL MEDICAL, INC. For: Aug 15
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 15, 2022
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction|
|(Commission File Number)||(IRS Employer|
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
(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|
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 15, 2022, Rockwell Medical, Inc. issued a press release and earnings presentation announcing its financial results for the quarter ended June 30, 2022. The press release and earnings presentation are furnished as Exhibit 99.1 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 Exhibit 99.1 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 Exhibit 99.1 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:
|104||Cover Page Interactive Data File, formatted in INline XBRL and included as Exhibit 101.|
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 15, 2022||By:||/s/ Mark Strobeck|
|Chief Executive Officer|
Rockwell Medical Announces Second Quarter 2022 Results
•Revenue was $18.7 million for the second quarter 2022, a 16% increase over the first quarter 2022, representing the highest quarterly revenue to-date for Rockwell
•Gross profit was $1.7 million in the second quarter 2022 compared to gross loss of $786,000 in the first quarter 2022
•Cash used in operating activities was $5.8 million for the second quarter 2022, a 40% decrease over the first quarter of 2022
•Completed $30 million financing and stabilized the business
Wixom, Michigan, August 15, 2022 – Rockwell Medical, Inc. (Nasdaq: RMTI), a commercial healthcare company focused on providing life-sustaining products for patients suffering from blood disorders and diseases associated with the kidney, today announced its operational and financial updates for the second quarter ended June 30, 2022.
SECOND QUARTER 2022 FINANCIAL HIGHLIGHTS
•Rockwell raised $30 million during the second quarter 2022, including a $15 million investment in the Company’s convertible preferred stock by DaVita, Inc.
•As of June 30, 2022, Rockwell had cash and cash equivalents of $30.8 million and 9,407,296 shares outstanding and 9,056,377 pre-funded warrants. In addition, the Company lowered its outstanding debt from $20.6 million at December 31, 2021 to $16.5 million at June 30, 2022.
•Revenue for the three months ended June 30, 2022 was $18.7 million. This represents a 16% increase quarter-over-quarter compared to $16.1 million for the three months ended March 31, 2022, and a 24% increase year-over-year compared to $15.1 million for the three months ended June 30, 2021.
•For the second quarter of 2022, gross profit was $1.7 million. This is compared to a gross loss of $0.8 million for the first quarter of 2022 and a gross loss of $0.3 million for the second quarter of 2021.
•Cash used in operating activities for the three months ended June 30, 2022 was $5.8 million, compared to $9.8 million for the three months ended March 31, 2022, representing a 40% decrease quarter-over-quarter.
•Rockwell effected a 1-for-11 reverse split of the Company’s issued and outstanding common stock on May 13, 2022.
•Rockwell regained compliance with Nasdaq listing requirements on May 31, 2022.
SECOND QUARTER 2022 OPERATING HIGHLIGHTS
•Rockwell appointed Mark Strobeck, Ph.D. as President and Chief Executive Officer.
•Rockwell expanded its hemodialysis concentrates partnership with DaVita, one of the leading providers of kidney care services in the United States.
•Rockwell has begun to right-size its business to improve the financial performance of its concentrates business and other business lines.
•Rockwell’s partner in South Korea, Jeil Pharmaceutical, commercially launched TRIFERIC® in South Korea subsequent to the second quarter 2022. Rockwell signed an exclusive license agreement with Jeil in September 2020 under which Jeil will be the exclusive development and commercialization partner for TRIFERIC® in South Korea. In consideration for the license, Rockwell received an upfront fee and will be eligible for milestone payments and royalties on net sales.
•Rockwell’s partner in China, Wanbang Biopharmaceuticals, a subsidiary of Shanghai Fosun Pharmaceutical, enrolled the final patient six months ahead of schedule, totaling 442 patients, in its pivotal Phase 3 clinical trial for TRIFERIC®.
•Rockwell has begun to address requests from the U.S. Food and Drug Administration for additional microbial and stability data for Rockwell’s FPC formulation for treatment of patients in the Home Infusion setting.
“In the second quarter, we took a number of important steps to stabilize our business, and are now in a better position to unlock the value that has been created by the Company,” said Mark Strobeck, Ph.D., President and CEO at Rockwell Medical. “Our improved relationships with our partners and our improved financial position afford us the ability to deliver more life-sustaining products to patients suffering from blood disorders and diseases associated with the kidney longer-term. Going forward, Rockwell’s focus will be to drive profitability for our overall business, to continually assess our strategic priorities and capital structure to manage cash and place Rockwell on firmer financial footing; and to develop our FPC programs to key value milestones consistent with a prudent capital deployment strategy. We expect to have more to say about these changes in the coming months,” concluded Dr. Strobeck.
CONFERENCE CALL AND WEBCAST DETAILS
Please call 10 minutes prior to the call to register.
Date: Monday, August 15, 2022
Time: 8:00am ET
Live Number: (888) 660-6347 // (International) 1 (929) 201-6594
Replay Number: (800) 770-2030 // (International) 1 (647) 362-9199
Access Code: 4944610
Speakers: Mark Strobeck, Ph.D., President and Chief Executive Officer; and Russell Skibsted, Chief Financial Officer and Chief Business Officer
Format: Discussion of second quarter 2022 operational and financial results followed by Q&A.
A replay will be available via the replay number and webcast through September 14, 2022.
About Rockwell Medical
Rockwell Medical is a commercial healthcare company focused on providing life-sustaining products for patients suffering from blood disorders and diseases associated with the kidney. Rockwell is the second largest supplier of acid and bicarbonate concentrates for dialysis patients in the United States. The Company is developing and commercializing a next-generation, proprietary parenteral iron technology platform, Ferric Pyrophosphate Citrate (“FPC”), which has the potential to transform treatment options for iron deficiency in multiple disease states, reduce healthcare costs and improve patients' lives. Rockwell has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. Rockwell is also advancing its FPC platform by developing FPC for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving medications in the home infusion setting. For more information, visit www.RockwellMed.com.
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend," "look forward to," "remain confident" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. There can be no assurance that Rockwell Medical will be able to maintain timing for planned clinical trials and regulatory filings, achieve planned cost savings to operate its concentrates business profitability, or that Rockwell Medical will be able to satisfy the funding conditions for the second tranche of the DaVita investment. 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 those risks more fully discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2021, 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.
Heather R. Hunter
Financial Tables Follow
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