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8-K - FISCAL YEAR 2014 EARNINGS RELEASE 8-K - ThermoGenesis Holdings, Inc.form8-k.htm

Exhibit 99.1
 
THERMOGENESIS CORP. REPORTS SECOND QUARTER FISCAL 2014 RESULTS
 
Company Obtains Approval for Acquisition of TotipotentRX
 
and Achieves Significant Clinical Milestones
 
RANCHO CORDOVA – February 14, 2014 – ThermoGenesis Corp. (NASDAQ: KOOL) (“ThermoGenesis”), a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, today reported financial results for the second quarter of  fiscal 2014.
 
For the quarter ended December 31, 2013, revenues were $4.5 million, compared to $4.8 million for the same period in 2012. The decrease in year-over-year revenues of $334 thousand was primarily attributable to fewer sales of our BioArchive Systems and the absence of ThermoLine revenues as a result of the sale of that product line.  These decreases were partially offset by an increase in sales associated with our bone marrow cell processing devices.  Revenues from our automated cord blood processing devices remained consistently strong when compared to the prior year quarter and have resumed historical levels as a result of the completion of the inventory wind down associated with the termination of the GE distribution agreement.
 
Operating expenses for the quarter ended December 31, 2013 were $3.4 million, compared to $2.5 million for the same period in 2012.  The increase in operating expenses of $858 thousand was primarily attributable to professional fees associated with the acquisition of TotipotentRX, legal diligence associated with patent litigation, and development costs associated with the advancement of our bone marrow cell processing platform that will be used in our AMIRST and CLIRST clinical trials.
 
Adjusted EBITDA loss was $1.3 million for the quarter ended December 31, 2013 compared to $297 thousand for the same period in 2012. Adjusted EBITDA loss increased by $1.0 million compared with the same period in 2012 due to an increase in professional fees associated with the acquisition of TotipotentRX, legal diligence associated with patent defense litigation and a decrease in revenues associated with our BioArchive devices and ThermoLine products.
 

 
Net loss for the quarter ended December 31, 2013 was $1.6 million or $0.10 per share, compared to $563 thousand or $0.03 per share for the same prior year period. The increase in the net loss of $1.0 million was primarily due to professional fees associated with the acquisition of TotipotentRX, legal diligence associated with patent defense litigation and a decrease in revenues associated with our BioArchive devices and ThermoLine products.
 
ThermoGenesis ended the second quarter with $2.3 million in cash compared to $6.9 million at the end of fiscal 2013.  The Company’s product backlog at the end of the second quarter was $505 thousand.  On January 30, 2014, we completed a private placement of 3.3 million shares of common stock, plus 1.7 million warrants, for net proceeds of approximately $6.1 million.
 
“We are very pleased to report our stockholders approval of the acquisition of TotipotentRX through a merger into ThermoGenesis at a Special Meeting of Stockholders yesterday” said Matthew T. Plavan, Chief Executive Officer of ThermoGenesis. “This acquisition represents the most important milestone to date in the transformation of ThermoGenesis into a fully integrated regenerative medicine company focused on bringing point-of-care, autologous cell therapies to market,” continued Plavan.  Incident to the acquisition ThermoGenesis will change its corporate name to Cesca Therapeutics Inc., which stands for Clinical Excellence in Stem Cell Applications.
 
“We are further encouraged to see continued stability in our base cord blood business,” said Plavan.  “Expanding our market share through competitive wins and geographic expansion are an important part of our overall growth strategy.”
 
Also, in January 2014 TotipotentRX and ThermoGenesis released the results of their Phase Ib clinical trial announcing safety and efficacy results treating no-option patients suffering from Critical Limb Ischemia with TotipotentRX’s CLI Rapid Stem Cell Therapy (CLIRST) combination kit product. CLIRST is a proprietary bedside technology platform and method which uses the patient’s own bone marrow stem cells to promote tissue repair through activation of natural stem-cell repair pathways, promotion of new blood vessel formation and prevention of on-going cell death.  “This ground-breaking product and procedure incorporating ThermoGenesis’ cell processing technology demonstrates that our integrated cell therapy successfully produced an amputation free survival rate of 82%, almost 25% higher than alternative therapeutic approaches to date,” said Ken Harris, CEO of TotipotentRX.
 

 
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“We see this as a significant advance in clinical treatments, as all the patients enrolled were scheduled for amputation of their afflicted limb prior to participating in the stem cell intervention,” continued Harris. “The goal of the stem cell therapy is to prevent major limb amputation, improve quality of life, decrease morbidity and mortality rates, and ultimately reduce the total healthcare costs of these patients.  Cesca intends for this study to be advanced to a randomized placebo-controlled Phase II/III clinical trial this summer.”
 
Non-GAAP Measures
 
In addition to the results reported in accordance with US GAAP, we also use a non-GAAP measure, adjusted EBITDA, to evaluate operating performance and to facilitate the comparison of our historical results and trends.  This financial measure is not a measure of financial performance under US GAAP and should not be considered in isolation or as a substitute for loss as a measure of performance.  The calculation of this non-GAAP measure may not be comparable to similarly titled measures used by other companies.
 
Conference Call and Webcast
 
Management will hold a conference call today at 2:00pm Pacific (5:00pm Eastern) to review the second quarter fiscal 2014 financial results.
 
Conference call details:
 
Dial-in (U.S.):
 
1-800-860-2442
 
Dial-in (Internationally):
 
1-412-858-4600
 
Conference Name:
 
“ThermoGenesis”
 

To listen to the audio webcast of the call during or after the event, please visit
http://www.thermogenesis.com/company/investor-relations/webcasts-calls/

An audio replay of the conference call will be available beginning approximately two hours after completion of the call for the following five business days.
To access the replay:
Access number (U.S.):
 
1-877-344-7529
 
Access number (Internationally)
 
1-412-317-0088
 
Conference ID#:
 
385107
 

 
About ThermoGenesis Corp.
 
ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood and bone marrow processing systems and companion disposable products that enable the separation, processing and preservation of cell and tissue therapy products. These include:
 
·  
AXP® AutoXpress® Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP® MarrowXpress® and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood.
 
·  
The MarrowXpress Platform (MXP), a derivative product of the AXP and its accompanying disposable bag set, isolates and concentrates stem cells from bone marrow.  Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood from bone marrow to a user defined volume in 30 minutes, while retaining over 90% of the MNCs.
 
·  
The Res-QTM 60 (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
 
·  
The BioArchive® System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.
 
Forward Looking Statement
 
This press release contains forward-looking statements. Such forward-looking statements include but are not limited to that TotipotentRX and ThermoGenesis will provide unmatched world-class capability and service to their clients and that the proposed merger will be completed. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements.  A more complete description of risks that could cause actual events to differ from the outcomes predicted by ThermoGenesis forward-looking statements is set forth under the caption "Risk Factors" in its annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.
 
ThermoGenesis Corp.
Web site: http://www.thermogenesis.com
Contact: Investor Relations
+1-916-858-5107, or
ir@thermogenesis.com


 
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Financials
 
ThermoGenesis Corp.
Condensed Balance Sheets
(Unaudited)

 
(in thousands, except share and per share amounts)
 
December 31,
2013
 
June 30,
2013
 
 
ASSETS
         
 
Current assets:
         
 
Cash and cash equivalents
 
$2,330
 
$6,884
 
 
Accounts receivable, net
 
5,538
 
4,898
 
 
Inventories
 
4,180
 
4,259
 
 
Prepaid expenses and other currentassets
 
136
 
232
 
             
 
Total current assets
 
12,184
 
16,273
 
             
 
Equipment, net
 
2,106
 
2,208
 
 
Other assets
 
48
 
48
 
             
     
$14,338
 
$18,529
 
 
Current liabilities:
         
 
Accounts payable
 
$2,737
 
$3,106
 
 
Other current liabilities
 
1,900
 
2,042
 
             
 
Total current liabilities
 
4,637
 
5,148
 
             
 
Long-term liabilities
 
69
 
63
 
             
 
Stockholders' equity
 
9,632
 
13,318
 
             
     
$14,338
 
$18,529
 


 
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ThermoGenesis Corp.
Condensed Statements of Operations
(Unaudited)

(in thousands, except share and per share amounts)
Three Months Ended
December 31,
 
Six Month Ended
December 31,
 
   
2013
 
2012
 
2013
 
2012
 
                   
Net revenues
 
$4,468
 
$4,802
 
$8,112
 
$8,924
 
                   
Cost of revenues
 
2,679
 
2,826
 
4,932
 
5,322
 
                   
            Gross profit
 
1,789
 
1,976
 
3,180
 
3,602
 
                   
                   
Expenses:
                 
                   
    Sales and marketing
 
713
 
735
 
1,428
 
1,391
 
                   
    Research and development
 
797
 
714
 
1,630
 
1,552
 
                   
    General and administrative
 
1,882
 
1,085
 
4,024
 
2,225
 
                   
    Gain on sale of product line
 
--
 
--
 
--
 
(2,000)
 
                   
        Total operating expenses
 
3,392
 
2,534
 
7,082
 
3,168
 
                   
Income (loss) from operations
 
(1,603)
 
(558)
 
(3,902)
 
434
 
                   
Interest and other income (expense), net
 
--
 
(5)
 
--
 
(2)
 
Net income (loss)
 
($1,603)
 
($563)
 
($3,902)
 
$432
 
                   
Per share data:
                 
                   
Basic and diluted net income (loss) per
  common share
 
($0.10)
 
($0.03)
 
($0.23)
 
$0.03
 
                   
Weighted average common shares
  outstanding:
                 
                   
Basic
 
16,682,730
 
16,522,310
 
16,672,811
 
16,519,078
 
                   
Diluted
 
16,682,730
 
16,522,310
 
16,672,811
 
16,519,654
 




 
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ThermoGenesis Corp.
Condensed Statements of Cash Flows
(Unaudited)

 
(in thousands)
Six Months Ended
December 31,
 
   
2013
 
2012
 
 
Cash flows from operating activities:
       
 
    Net income (loss)
($3,902)
 
$432
 
 
    Adjustments to reconcile net loss to net cash used
       in operating activities:
       
 
         Depreciation and amortization
327
 
266
 
 
         Stock based compensation expense
284
 
272
 
 
         Loss on disposal of equipment
--
 
7
 
 
         Gain on sale of product line
--
 
(2,000)
 
 
         Net change in operating assets and liabilities:
       
 
              Accounts receivable, net
(640)
 
(797)
 
 
              Inventories
7
 
710
 
 
              Prepaid expenses and other current assets
96
 
(82)
 
 
              Accounts payable
(369)
 
(1,087)
 
 
              Accrued payroll and related expenses
54
 
(168)
 
 
              Deferred revenue
--
 
(135)
 
 
              Other liabilities
(190)
 
87
 
           
 
         Net cash used in operating activities
(4,333)
 
(2,495)
 
 
Cash flows from investing activities:
       
 
     Capital expenditures
(153)
 
(314)
 
 
     Proceeds from sale of product line
--
 
2,000
 
 
     Proceeds from prepayment from sale of product line
--
 
500
 
           
 
         Net cash provided by (used in) investing activities
(153)
 
2,186
 
           
 
Cash flows from financing activities:
       
 
     Repurchase of common stock
(68)
 
(54)
 
           
 
         Net cash used in financing activities
(68)
 
(54)
 
           
 
Net decrease in cash and cash equivalents
(4,554)
 
(363)
 
           
 
Cash and cash equivalents at beginning of period
6,884
 
7,879
 
 
Cash and cash equivalents at end of period
$2,330
 
$7,516
 
           
 
Supplemental non-cash financing and investing information:
       
 
Transfer of inventories to equipment
$57
 
$214
 



 
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ThermoGenesis Corp.
Adjusted EBITDA
(Unaudited)

 
(in thousands)
 
Three Months Ended
December 31,
 
Six Months Ended
December 31,
 
     
2013
 
2012
 
2013
 
2012
 
 
Loss from operations
 
($1,603)
 
($558)
 
($3,902)
 
$434
 
                     
 
Add (subtract):
                 
                     
 
Depreciation and amortization
 
171
 
132
 
327
 
266
 
                     
 
Stock-based compensation expense
 
115
 
129
 
284
 
272
 
                     
 
Gain on sale of product line
 
--
 
--
 
--
 
(2,000)
 
                     
 
Adjusted EBITDA loss
 
($1,317)
 
($297)
 
($3,291)
 
($1,028)
 

 

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