0001171843-16-010050.txt : 20160513 0001171843-16-010050.hdr.sgml : 20160513 20160513170016 ACCESSION NUMBER: 0001171843-16-010050 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160510 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160513 DATE AS OF CHANGE: 20160513 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ROCKWELL MEDICAL, INC. CENTRAL INDEX KEY: 0001041024 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 383317208 STATE OF INCORPORATION: MI FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23661 FILM NUMBER: 161649230 BUSINESS ADDRESS: STREET 1: 30142 S WIXOM RD CITY: WIXOM STATE: MI ZIP: 48393 BUSINESS PHONE: 2489609009 MAIL ADDRESS: STREET 1: 30142 S WIXOM RD CITY: WIXOM STATE: MI ZIP: 48393 FORMER COMPANY: FORMER CONFORMED NAME: ROCKWELL MEDICAL TECHNOLOGIES INC DATE OF NAME CHANGE: 20120530 FORMER COMPANY: FORMER CONFORMED NAME: ROCKWELL MEDICAL, INC. DATE OF NAME CHANGE: 20120525 FORMER COMPANY: FORMER CONFORMED NAME: ROCKWELL MEDICAL TECHNOLOGIES INC DATE OF NAME CHANGE: 19970722 8-K 1 f8k_051316.htm FORM 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): May 10, 2016

 

 

ROCKWELL MEDICAL, INC.
(Exact name of registrant as specified in its charter)

 

 

Michigan   000-23661   38-3317208
(State or other jurisdiction    (Commission   (IRS Employer
of incorporation)   File Number)      Identification No.)

 

 

30142 Wixom Road, Wixom, Michigan    48393
(Address of principal executive offices)         (Zip Code)

 

Registrant's telephone number, including area code          (248) 960-9009                 

 

 

  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 (see General Instruction A.2. below):

 

[ ] 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))

 

 

 

Item 2.02      Results of Operations and Financial Condition.

 

On May 10, 2016, the Company issued the press release attached hereto as Exhibit 99.1, announcing its financial results for the quarter ended March 31, 2016.

 

A transcript of the call relating to the May 10, 2016 release announcing financial results for the quarter ended March 31, 2016 is attached hereto as Exhibit 99.2. The transcript includes a brief discussion of the Company’s operating results for the period excluding the effect of the foreign taxes associated with the execution of the Wanbang Agreement (a non-GAAP measure). The Company’s reported earnings are prepared in accordance with GAAP and represent earnings as reported to the Securities and Exchange Commission. The Company’s management believes that the disclosure of GAAP earnings adjusted for the effect of this item, which item is not indicative of the Company’s core operations, provides additional information that is useful to investors in understanding the Company’s underlying performance and helps to facilitate period to period comparisons. However, non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.

 

(in millions) Three Months Ended March 31,
  2016 2015
Reported Net Loss (GAAP) ($4.8) ($3.7)
Cost of Sales (.3) -
Income Tax Expense (.4)        -
Adjusted Net Loss (Non-GAAP) ($4.1) ($3.7)

 

 

Item 9.01      Financial Statements and Exhibits.

 

The following exhibits are furnished with this Form 8-K:

 

  Exhibit   Description
       
  99.1   Press Release dated May 10, 2016.
  99.2   Transcript of May 10, 2016 earnings call.

 

 

 2 

 

 

SIGNATURES

 

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.
       
       
May 13, 2016 By:  /S/ Thomas E. Klema  
    Thomas E. Klema  
    Its: Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 3 

 

 

EXHIBIT INDEX

 

 

  Exhibit   Description
       
  99.1   Press Release dated May 10, 2016.
  99.2   Transcript of May 10, 2016 earnings call.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4

 

 

EX-99.1 2 exh_991.htm EXHIBIT 99.1 EdgarFiling

EXHIBIT 99.1

Rockwell Medical Reports First Quarter Results

WIXOM, Mich., May 10, 2016 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported results for the first quarter of 2016.

Q1 2016 Financial Highlights

  • Sales were $13.6 million, compared to $13.9 million in Q1 2015, or 1.9% less than Q1 2015.
  • Dialysis concentrate sales increased $0.2 million while contract manufacturing sales decreased $0.5 million.
  • Gross profit was $1.7 million compared to $2.3 million in Q1 2015.
    • Gross profit was impacted by a one-time $0.3 million value add tax related to the Wanbang Triferic license agreement payment of $4 million.
  • SG&A expense was $5.0 million compared $5.3 million in Q1 2015.
  • R&D expense was $1.3 million compared to $0.8 million in Q1 2015.
  • Income tax expense was $0.4 million, related to the $4 million Wanbang license payment.
  • Net loss was ($4.8) million or ($0.10) per share compared to ($3.7) million or ($0.07) per share in Q1 2015.
    • Net loss was impacted by a one-time $0.7 million charge related to the Wanbang Triferic license agreement payment of $4 million.
  • Cash and investments were $69.4 million as of March 31, 2016.


2016 
YTD Corporate Highlights

  • Received FDA approval to market Triferic® powder packet presentation, which is a more convenient package for customers that reduces storage space and requires fewer reorders to maintain inventory.
  • Signed exclusive license and manufacturing supply agreement with Wanbang Biopharma for the rights to commercialize Triferic and Calcitriol in the People's Republic of China. The agreement calls for up to $39 million in milestone payments and ongoing profit on commercial product sales following drug approval in China.


Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell, stated, "We completed two key objectives in our growth strategy during the first few months of 2016. We secured our first major international partnership, signing a license and supply agreement for the rights to commercialize Triferic and Calcitriol in the People's Republic of China. We expect China will become the largest dialysis market in the world over the next several years. Also, we received our second FDA approval for Triferic, with the April approval of the Triferic powder packet. Gaining this approval is a significant advancement, and it will provide both production and distribution efficiencies for Triferic.”  Mr. Chioini further stated, “We continue to make solid progress on our marketing and reimbursement initiatives with Triferic. This spring we have exhibited at several conferences and as expected there has been high interest in Triferic across the spectrum of stakeholders. We also continue to make progress to obtain transitional add-on reimbursement for Triferic, which we believe will provide a positive catalyst for providers in adopting Triferic as it will offset their cost of conversion to an innovative therapy that benefits their patients.”

Conference Call Information
Rockwell Medical will be hosting a conference call to review its fourth quarter 2015 results on Tuesday, May 10, 2016 at 4:30 pm ET.  Investors are encouraged to call a few minutes in advance at (877) 548-7915, or for international callers (719) 325-4748, passcode # 9698841 or to listen to the call via webcast at the Rockwell Medical IR web page: http://ir.rockwellmed.com/

About Triferic
Triferic is a unique iron replacement product that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is added to the bicarbonate concentrate on-site at the dialysis clinic. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. In completed clinical trials, Triferic has demonstrated that it can effectively deliver sufficient iron to the bone marrow and maintain hemoglobin, without increasing iron stores (ferritin). Please visit www.triferic.com or call Rockwell Medical at 800-449-3353 for more information.

About Rockwell Medical
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis.

Rockwell’s recent FDA approved drug Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials, Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market.

Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market.

Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three manufacturing/distribution facilities located in the U.S.

Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to sell and market Calcitriol and Triferic. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “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. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter 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.

ROCKWELL MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS
For the three months ended March 31, 2016 and March 31, 2015
(Unaudited)
    
  Three Months EndedThree Months Ended
   March 31, 2016   March 31, 2015
 Sales$13,627,048  $  13,883,961 
 Cost of Sales 11,932,122   11,571,618 
 Gross Profit 1,694,926   2,312,343 
 Selling, General and Administrative 4,986,741   5,325,761 
 Research and Product Development   1,314,430     799,591 
 Operating Income (Loss) (4,606,245)  (3,813,009)
 Interest and Investment Income, net 186,562   113,815 
 Interest  Expense   -     - 
 Income (Loss)  Before  Income Taxes (4,419,683)  (3,699,194)
 Income Tax Expense   404,527     -  
 Net Income (Loss)$  (4,824,210) $  (3,699,194)
    
 Basic Income (Loss) per Share$(0.10) $(0.07)
    
    
 Diluted Income (Loss)  per Share$(0.10) $(0.07)



ROCKWELL MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
As of March 31, 2016 and December 31, 2015
(Unaudited)
 
ASSETS
March 31,
2016

 
December 31,
2015

Cash and  Cash Equivalents$  30,007,500  $  31,198,182 
Investments Available for Sale 39,435,500   39,482,732 
Accounts Receivable, net of a reserve of $35,000 in 2016 and $75,000 in 2015 6,223,520   5,046,733 
Inventory 9,163,932   7,871,780 
Other Current Assets 931,774   1,026,889 
Total Current Assets 85,762,226   84,626,316 
   
Property and Equipment, net 1,690,116   1,646,568 
Intangible Assets 123,944   165,657 
Goodwill 920,745   920,745 
Other Non-current Assets   600,687     462,839 
Total Assets$  89,097,718  $  87,822,125 
   
   
LIABILITIES AND SHAREHOLDERS' EQUITY
  
Accounts Payable$  4,420,468  $  3,995,216 
Accrued Liabilities 3,494,794   3,831,356 
Customer Deposits   93,646     264,879 
Total Current Liabilities   8,008,908     8,091,451 
   
Deferred License Revenue 20,883,712   17,410,852 
   
   
Shareholders’ Equity:  
Common Shares, no par value, 51,526,877 and 51,501,877shares  issued and outstanding 260,530,213    257,773,494 
Accumulated Deficit (199,362,386)  (194,538,176)
Accumulated Other Comprehensive Income   (962,729)    (915,496)
Total Shareholders’ Equity   60,205,098     62,319,822 
Total Liabilities And Shareholders' Equity$
  89,097,718  $
  87,822,125 


ROCKWELL MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the three months ended March 31, 2016 and March 31, 2015
(Unaudited)
 
  2016    2015 
   
Cash Flows From Operating Activities:  
Net (Loss)$  (4,824,210)  $  (3,699,194)
Adjustments To Reconcile Net Loss To Net Cash Used In  
Operating Activities:  
Depreciation and Amortization 200,089    207,858 
Share Based Compensation- Employees 2,679,468    3,292,584 
Restricted Stock Tendered in Satisfaction of Tax Liabilities -    (1,463,601)
Loss on Disposal of Assets 506    2,424 
   
Changes in Assets and Liabilities:  
(Increase) in Accounts Receivable (1,176,787)   (193,829)
(Increase) in Inventory (1,292,152)   (1,275,821)
(Increase) in Other Assets (42,733)   (226,301)
Increase (Decrease) in Accounts Payable 425,252    (156,661)
Increase (Decrease) in Other Liabilities   (507,795)     691,984 
Deferred License Revenue   3,472,860      (493,227)
Changes in Assets and Liabilities   878,645      (1,653,855)
Cash (Used In) Operating Activities   (1,065,502)     (3,313,784)
   
Cash Flows From Investing Activities:  
Purchase of Equipment   (202,430)     (77,705)
Proceeds from Sale of Assets   -      4,800 
Cash Provided By (Used In) Investing Activities (202,430)   (72,905)
   
Cash Flows From Financing Activities:  
Proceeds from the  Issuance of Common Shares and Purchase  Warrants   77,250      918,884 
Cash Provided By Financing Activities 77,250    918,884 
   
Increase (Decrease) In Cash (1,190,682)   (2,467,805)
Cash At Beginning Of Period   31,198,182      65,800,451 
Cash At End Of Period$  30,007,500   $  63,332,646 

 

Michael Rice, Investor Relations; 646-597-6979

EX-99.2 3 exh_992.htm EXHIBIT 99.2

EXHIBIT 99.2

 

 

THOMSON REUTERS STREETEVENTS

 
 

EDITED TRANSCRIPT

   
  RMTI - Q1 2016 Rockwell Medical Inc Earnings Call
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   

 

 

 

 

 

 

 

 

 

 

EVENT DATE/TIME: MAY 10, 2016 / 08:30PM GMT

 

  1

 

MAY 10, 2016 / 08:30PM GMT, RMTI - Q1 2016 Rockwell Medical Inc Earnings Call

 

 

CORPORATE PARTICIPANTS

Paul Arndt LifeSci Advisors - IR

Rob Chioini Rockwell Medical, Inc. - Founder, Chairman, CEO

Tom Klema Rockwell Medical, Inc. - CFO

 

 

CONFERENCE CALL PARTICIPANTS

Charles Haff Craig-Hallum Capital Group - Analyst

 

 

PRESENTATION

 

 

 

Operator

 

Good day, and welcome, everyone, to the Rockwell Medical first-quarter 2016 earnings call. Today's conference is being recorded. At this time I would like to turn the conference over to Paul Arndt. Please go ahead, sir.

 

 

Paul Arndt - LifeSci Advisors - IR

 

Thank you Cecilia, and good afternoon, everyone. Thank you for attending Rockwell Medical's first-quarter 2016 financial results conference call. I am Paul Arndt, Managing Director of LifeSci Advisors. On the call this afternoon are Rob Chioini, Founder, Chairman and CEO, and Tom Klema, Chief Financial Officer.

 

Before we begin, I would like to remind everyone that various remarks about future expectations, plans and prospects constitute forward-looking statements for purposes of safe harbor provisions under the Private Securities Litigation Reform Act of 1995.

 

Rockwell cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. Among the factors that could cause actual results to differ materially include risks and uncertainties related to Triferic, including the Company's ability to successfully commercialize Triferic, manufacturing capabilities, and other risk factors identified from time to time in reports filed with the Securities and Exchange Commission. Any forward-looking statements made on this conference call speak only as of today's date, Tuesday, May 10, 2016, and the Company does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today's date.

 

This conference call is being recorded for audio re-broadcast on Rockwell Medical's website at www.rockwellmed.com. All participants on this call will be listen-only. The call will be followed by a brief question-and-answer session.

 

I will now turn the call over to Rob Chioini, Founder, Chairman and CEO of Rockwell Medical. Go ahead, Rob.

 

 

Rob Chioini - Rockwell Medical, Inc. - Founder, Chairman, CEO

 

Thank you, Paul. Good afternoon. Thank you for joining us on the call. Our quarterly results are similar to last year, plus a couple one-time charges. Tom will provide you with more detail in a few minutes on that.

 

I want to share with everyone on this call today why we are extremely excited about the future of Rockwell Medical. We believe we are on the cusp of a new multi-year growth phase that will be driven by the commercial success of our proprietary platform drug, Triferic.

 

Our initial FDA approval for this one-of-a-kind drug is to replace iron during every dialysis treatment and maintain hemoglobin in the hemodialysis patient. Triferic addresses a very significant unmet need in treating iron deficiency in these patients.

 

There is no other drug like it in the world. The worldwide market potential for treating hemodialysis patients with Triferic is approximately $1 billion. The market potential for the other therapeutic indications we are beginning to pursue could be an additional $1 billion or more.

 

  2

 

MAY 10, 2016 / 08:30PM GMT, RMTI - Q1 2016 Rockwell Medical Inc Earnings Call

 

 

We have worked extremely hard over the last 10 years to get to this point. Now, there is always more work to be done, but the heavy lifting has been completed and the foundation has been laid. Our immediate efforts are focused on two areas -- continuing to educate the market on Triferic's significant clinical and economic benefits for dialysis patients and dialysis providers, respectively; and obtaining the proper reimbursement for Triferic.

 

No matter how great the product, it still has to be sold. With Triferic, which is a revolutionary way to replace iron, we continue to educate our customers, the docs, the nurses, technicians, administrators -- all the stakeholders this product touches.

 

This educational process is ongoing, and the response continues to be exceptional. Potential users become extremely excited when they learn about Triferic's unique mode of action -- how it's able to bind iron immediately to transferrin, which is something current therapy cannot do.

 

Regarding reimbursement, we continue to work diligently to obtain separate reimbursement outside of the bundled payment. As I've mentioned before, it's called transitional add-on payment. To provide clarity, transitional add-on payment allows for reimbursement of a drug to be set at approximately 106% of the average sale price for approximately 2 years.

 

This reimbursement to dialysis providers covers their cost associated with acquiring and using a new and innovative therapy such as Triferic for their patients in their clinics. The 2-year transitional period enables CMS to determine the average sale price and utilization rate over that time, while also collecting other clinical data. After the transitional period ends, a calculation is made based on the average sale price to arrive at a dollar amount that is then added onto the bundled payment, which is to cover the drug's cost going forward. So, for example, after 2 years, CMS could add $5 to the bundle of $245 to cover reimbursement for Triferic.

 

Because we are deep into the process, and because of the sensitive nature of it, I am limited in what I can say. But I can assure you that we continue to make solid progress.

 

There are many reasons Triferic should be granted add-on status. One of the most important is that congressional action in 2014 gave direction to CMS to approve transitional add-on payment for new drugs. Congress took specific action in the rule for calendar year 2016 to address new, innovative drugs by directing CMS to create a process for including new injectable and intravenous products into the bundled payment. Triferic falls squarely into this direction for action by Congress.

 

From a pragmatic standpoint, Triferic is an innovative therapy that did not exist before the bundle reimbursement went into effect in 2011. There was no way to set its price in the bundle. It clearly fits the pathway of an innovative therapy, where CMS itself has noted that it needs to make exceptions for these types of therapies under the current bundle.

 

And Triferic is good for dialysis patients. It addresses the significant unmet need in treating their anemia. It is able to improve clinical outcomes in a beneficial way that no other drug can. Making innovative therapies like Triferic accessible to patients to improve their lives is one of the most important initiatives CMS is tasked with, and it's the right thing to do. Obtaining add-on payment for Triferic is a top priority of our entire management team, and we continue to work for it with relentless sense of urgency.

 

As I mentioned prior, this process is fluid. There's no way to predict the exact timing of receiving add-on payment. We hope to have finality on it very soon. In the meantime, we continue educating the market on Triferic's clinical benefits and economic benefits.

 

We are also very excited about obtaining FDA approval to market Triferic in powder packet form. We received this FDA approval 2 weeks ago, consistent with our guidance on our last call.

 

The Triferic powder packet is similar to the size of a packet of sugar. It's much smaller and lighter than the current Triferic liquid ampule. It enables us to place 100 packets in a carton versus 24 liquid ampules. This presentation is much more convenient for customers. It reduces storage space, and requires fewer reorders to maintain inventory. We expect it to be commercially available very soon.

 

And we are excited about our ongoing business development efforts as well. Coming off our significant license agreement with Wanbang Biopharma for the rights to Triferic and Calcitriol for all of China, we continue to make good progress on other territories with potential partners.

 

You can appreciate there's little we can say until the discussions for the next partnership have been finalized. But I can say we are very active, and we look forward to giving an update at the appropriate time.

 

Before I turn the call over to Tom, I want to mention the issue we experienced last week with Calcitriol, our FDA-approved generic vitamin D injection. As we stated, we were informed by our CMO that an [in]active ingredient in the finished product fell out of specification for stability. The timing of this was obviously not ideal, but these things occur on occasion in manufacturing.

 

  3

 

MAY 10, 2016 / 08:30PM GMT, RMTI - Q1 2016 Rockwell Medical Inc Earnings Call

 

 

Our technical experts along with our CMO's technical experts are working to identify and implement corrective and preventative actions, and we expect to have this issue resolved and to be able to offer Calcitriol for commercial sale as soon as possible.

 

I will now turn the call over to Tom Klema, our CFO.

 

 

Tom Klema - Rockwell Medical, Inc. - CFO

 

Well, thank you, Rob, and good afternoon. I'll be covering the financial results for the first quarter. I want to start today by addressing a transaction that might be somewhat confusing in reviewing our reported results.

 

As you know, we completed a very significant transaction this quarter with the completion of the Wanbang license and supply agreement. We received a $4 million upfront payment in consideration of the license and other deliverables. That payment created a taxable event in China. We had to pay an income tax in China and a value-add tax for China as well, and as a result we netted $3.3 million in cash.

 

From an accounting standpoint, the accounting rules require us to recognize that upfront payment of $4 million over the term of the license agreement. That is why we do not show a $4 million increase in sales on the P&L. Accounting rules also require us to expense the foreign taxes paid, with $300,000 in cost of sales for the value-added tax and $400,000 in income taxes on the income tax expense line. The total tax expense recognized related to the Wanbang transaction was $700,000.

 

We will be able to offset the income tax paid in China as the credit against future US income taxes on our overall business. As a result of the Wanbang transaction, our reported income was reduced by $700,000 for these foreign taxes, which accounts for the majority of the increase in our loss for our first quarter this year versus last year, and represents over half of the change in the loss per share.

 

The accounting rules may seem a bit counterintuitive and confusing, so I want to reemphasize that we received a net of $3.3 million in cash after taxes from the license agreement, but due to the accounting rules we had to record a net expense of $700,000 for the quarter.

 

I also want to point out that had we done a deal in, say, United States, which would have created US taxable income here, we would have used a portion of our net operating loss carryforwards to offset US income tax liabilities, and we would not have had to recognize the income taxes; but because the taxes were paid to a foreign government, we had to recognize those foreign taxes in our results.

 

Next, I will cover our business operations. And on sales, our dialysis concentrate sales make up the majority of our sales. The first-quarter total sales were $13.6 million, which were $300,000 or 1.9% less than in the first quarter of 2015.

 

International dialysis concentrate revenue in the first quarter of 2016 was $100,000 lower, while domestic dialysis concentrate revenue increased $300,000. Contract manufacturing sales were $0.5 million lower as a result of completion of a contract where the customer discontinued the product line.

 

On our gross profit, the gross profit in the first quarter was $1.7 million, $600,000 less than the first quarter of last year. We were required to recognize $300,000 from the value-add tax in conjunction with the $4 million payment we received from Wanbang. Gross profit was also reduced by lower contract manufacturing sales compared to the first quarter of 2015.

 

Our SG&A expenses for the quarter were $5 million compared to $5.3 million in the first quarter last year. The decrease in expense was primarily due to a $600,000 decrease in non-equity compensation of $2.7 million. We had an increase in expenses for personnel, marketing, drug business administration and other intellectual property of approximately $300,000, which partially offset the decrease.

 

Our research and development expense was in the range we had anticipated. R&D was $1.3 million in the first quarter compared to $800,000 in the first quarter last year. R&D was higher than the first quarter last year due to work on the additional indications and regulatory approvals. However, R&D expense over the last four quarters has averaged about the same level as the first quarter of 2016.

 

On income tax expense, we recognized approximately $400,000 income tax expense in the first quarter, compared to no income tax expense in last year's first quarter. Our income tax expense pertains to foreign income taxes paid related to license payments received under the Wanbang agreement. The amount of foreign income tax paid can be credited against future US tax liabilities and carried forward to offset future US income tax liabilities.

 

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MAY 10, 2016 / 08:30PM GMT, RMTI - Q1 2016 Rockwell Medical Inc Earnings Call

 

 

Our net loss for the quarter was $4.8 million compared to $3.7 million in the first quarter of 2015. As I mentioned earlier, the taxes related to the Wanbang license agreement represented $700,000 of the difference in loss.

 

Without this one-time transaction, the overall operating results were approximately $400,000 less than in the first quarter last year. Reduction in income was due to lower gross profit of $300,000 and higher R&D cost of $500,000, partially offset by lower SG&A expense of $400,000.

 

Our loss per share was $0.10 compared to $0.07 last year in the first quarter.

 

On liquidity and capital resources, our cash position is solid. We have adequate cash resources to support development of our drug business operations and the associated working capital. At March 31 we had current assets of $85.8 million; net working capital of $77.8 million. We have approximately $69.4 million in cash and investments. Our uses of cash have been primarily for marketing, research and product development, investments in inventory to support our product launches, and for operating expenses.

 

Cash flow from operations used $1.1 million in the first quarter of 2016, which included R&D expense of $1.3 million and an increase of $1.3 million in inventory. We also received $3.3 million net of tax pursuant to the Wanbang Agreement. Our capital expenditures were $200,000, and were roughly equivalent to our depreciation and amortization costs.

 

We anticipate that we will increase our inventory and accounts receivable as we increase our drug product sales. While we also expect to invest in research and product development in 2016, spending on these indications is expected to be minor in relation to our current cash resources. We have adequate capital resources to make these investments in accounts receivable, inventory and research and product development.

 

I'll now turn the call back to our operator, Cecilia, for some Q&A.

 

QUESTION AND ANSWER

 

 

Operator

 

(Operator Instructions). Charles Haff, Craig-Hallum.

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

Question for you on Triferic. In terms of incremental new pilots or new commercialization efforts, have you been doing anything new on the ampule side while you've been working on the powder formation? Anything to report there in terms of new development on the customer side?

 

 

Rob Chioini - Rockwell Medical, Inc. - Founder, Chairman, CEO

 

Well, we haven't been doing anything new on the ampule side. If you're asking me about the product specifically, the product that's in use now in a handful of clinics is the ampule.

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

Okay. And then on the Calcitriol, since you've put out the press release, do you have any other refinements to the timing and how long it may take to fix this manufacturing issue?

 

 

Rob Chioini - Rockwell Medical, Inc. - Founder, Chairman, CEO

 

Well, I mean, nothing's changed since last week. The -- it's called an excipient -- it's an inactive ingredient -- was out on stability.

 

And what you have happen when something like that happens, is just some analysis takes place, and a determination is made. Was it a lab error? Was it something in the process? Product has been made prior to that and we didn't have that result, so it's something that's correctable.

 

 

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MAY 10, 2016 / 08:30PM GMT, RMTI - Q1 2016 Rockwell Medical Inc Earnings Call

 

 

We certainly don't feel like it's a major issue that would prevent us from getting the product to the market. It's, for lack of a better word, more unfortunately run-of-the-mill. But the analysis has to take place. We've got to make certain we know why it occurred and -- so it doesn't occur with the next commercial batch.

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

Okay. And then, I haven't heard you guys talk about CitraPure for a while. Wondering if you could kind of give us an update on where the penetration of CitraPure stands relative to your overall dialysate business.

 

 

Rob Chioini - Rockwell Medical, Inc. - Founder, Chairman, CEO

 

I think, off the cuff here, it's probably about 80%, 85% of our customers use the product CitraPure. We continue to sell it. New customers continue to go on it. If there's any existing, sooner or later they convert to it.

 

Personally, I was at a conference not this weekend, the weekend before, and we had a lot of activity at the booth. Most of it obviously was Triferic; but still, some really good activity on CitraPure. So, it's -- we don't see it -- I don't believe that the industry's ever going to change and go back to an acetate product.

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

Okay. And I think originally you were kind of thinking there would be a price premium, and you saw that. Has that price premium kind of dissipated or are you able to maintain that with some accounts?

 

 

Rob Chioini - Rockwell Medical, Inc. - Founder, Chairman, CEO

 

Well, keep in mind we have an agreement with Baxter now. And up until that agreement, we continued to get higher prices on CitraPure, I think in combination with just raising prices on an annual basis or a contractual basis, as they rolled over. But we -- that was going on. I believe that Baxter is pricing to end users very much like we were, where prices are higher for the product.

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

Okay. And then that's a good segue for -- I wanted to ask you about the Baxter agreement, now that that's been up and running for a little while now. I know when you announced it, you were talking about maybe building a new facility west of the Rockies, and just wanted to kind of get any color in terms of progress, and how that arrangement has been going, and what -- if there are some plans for expansion of that relationship.

 

 

Rob Chioini - Rockwell Medical, Inc. - Founder, Chairman, CEO

 

Yes. I mean, the process has been going good. The expansion -- we actually have identified some facilities on the West Coast and are doing some work on choosing a facility. And our expectation, without giving any kind of drop-dead date, would be that -- at least today I can tell you on the call, our expectation is to break ground on a facility before the end of this year.

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

Oh, that's great.

 

 

Rob Chioini - Rockwell Medical, Inc. - Founder, Chairman, CEO

 

That can change, but today, as we sit here on the phone, that's the plan.

 

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MAY 10, 2016 / 08:30PM GMT, RMTI - Q1 2016 Rockwell Medical Inc Earnings Call

 

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

Okay. And my last question is for Tom. Tom, on gross margin, do you think this is kind of a steady-state gross margin that we should expect for the remaining quarters of the year, or do you think that might fluctuate here and there?

 

 

Tom Klema - Rockwell Medical, Inc. - CFO

 

I think -- obviously, the taxes related to the Wanbang transaction would not recur. And then -- and so, I think if you back out that $300,000, that could probably put you at the base that we're at right now. And to the extent we add the drug sales in future quarters, then obviously the margins will go up from there.

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

Okay. Oh, sorry I lied. I have one more. The $2.7 million of stock comp for this quarter -- is that -- are you expecting similar levels for the remaining quarters as well?

 

 

Tom Klema - Rockwell Medical, Inc. - CFO

 

Were you asking about R&D? I'm sorry. I missed (inaudible).

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

No, stock comp. Stock compensation.

 

 

Tom Klema - Rockwell Medical, Inc. - CFO

 

Oh, yes. I would expect it to be about the same level as it is in this quarter.

 

 

Charles Haff - Craig-Hallum Capital Group - Analyst

 

Okay. Great. Thanks for taking my questions.

 

 

Operator

 

And with no further questions, I'd like to turn the conference back over to Rob Chioini for any additional or closing remarks.

 

 

Rob Chioini - Rockwell Medical, Inc. - Founder, Chairman, CEO

 

Well, we have appreciate your continued support and we look forward to updating you on the next call. Thank you.

 

 

Operator

 

And that does conclude today's conference. We appreciate everyone's participation.

 

 

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