Tuesday, August 12, 2014

Transcript of today's R&D and Business Results for Second Quarter and First Half of 2014 convference call available on Seeking Alpha






Transcript of today's R&D and Business Results for Second Quarter and First Half of 2014 convference call available on Seeking Alpha (Click Here).

http://seekingalpha.com/article/2415655-international-stem-cell-isco-q2-2014-results-earnings-call-transcript?uprof=25






International Stem Cell Corporation Provides R&D and Business Results for Second Quarter and First Half of 2014

CARLSBAD, CA. - (Marketwired - August 12, 2014), International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell based therapies and biomedical products today provided a business update and announced financial results for the three and six months ended June 30, 2014.

“We’ve taken another important step forward in our Parkinson’s Disease program in completing the acute toxicity study,” said Dr. Andrey Semechkin, the Company’s CEO and Co-Chairman. “Also encouraging are the signs of behavioral improvements after six months in the primate study. Both of these studies are pivotal to a successful IND submission and it’s good to be able to report solid progress. We expect to give a more complete update on our Parkinson’s disease program before the end of this quarter.”

“As I suggested in last quarter’s update, our revenues have continued with the eighth consecutive quarter of growth on a year over year basis. The increase in our cash burn is also as anticipated reflecting the substantial increase in R&D spending. I recognize that our cash position remains challenging, but I continue to be committed to supporting the company until such a time as we can bring in additional investment on appropriate terms,” concluded Dr. Semechkin.

Highlights:
  • Reported behavioral improvements after six months in the ongoing IND-enabling pharmacology/toxicology Parkinson’s disease study in primates using human neural stem cells (hpNSC) derived from ISCO’s unique, proprietary parthenogenetic stem cell platform. These results were presented at the 66th American Academy of Neurology Annual Meeting in Philadelphia.
  • Announced the completion of the hpNSC acute toxicity study an important part of the Investigational New Drug application. The study transplanted hpNSC into rodents and showed that the human cells are well tolerated even at high doses up to the equivalent of 2.2 billion cells in humans.
  • Entered into a research agreement with Rohto Pharmaceutical Company Ltd, a global Japanese pharmaceutical company in early July. Under the agreement Rohto will evaluate ISCO’s human stem cells in a number of pre-clinical animal models as a precursor to potentially signing a definitive license agreement.
  • Lifeline Skin Care signed a distribution agreement with Mexico's largest distributor of aesthetic and reconstructive products. Grupo Venta Internacional now offers Lifeline’s breakthrough stem cell skin care products to health care professionals throughout Mexico, the second largest market for aesthetic skin care in Central and South America. 
  • Revenues up 18% year-over-year to $3.24 million for the six months ended June 30, 2014.
Lifeline Cell Technology (LCT) contributed $842,000 for the three months ended June 30, 2013compared to $748,000 for the same period of 2013. The increase of $94,000 or 13% in LCT revenue was driven primarily by higher sales to OEM customers and international distributors. Lifeline Skin Care (LSC) contributed $746,000 for the three months ended June 30, 2014, compared to $709,000 for the same period of 2013. The increase of $37,000 or 5% in LSC’s revenue is due to our strategic efforts to expand and diversify sources of revenue across all channels. We saw the greatest sales growth in website sales and professional accounts. LCT contributed $1.69 million in the six months ended June 30, 2014, compared to $1.38 million for the six months ended June 30, 2013. LCT’s revenue increased by $305,000 or 22%, primarily due to higher sales to OEM customers and international distributors. LSC’s revenue of $1.55 million in the six months ended June 30, 2014, compared to $1.36 million in the six months ended June 30, 2013. The increase of $190,000 or 14% in LSC’s revenue was a result of our strategic efforts to expand and diversify our sources of revenue.

Cost of sales for the three months ended June 30, 2014 was $409,000 or 26% of revenue, compared to $329,000 or 23% of revenue for the three months ended June 30, 2013. Cost of sales for the six months ended June 30, 2014 was $848,000 or 26% of revenue, compared to $663,000 or 24% of revenue for the same period in 2013. These increases are primarily due to a shift in sales mix from higher margin products to lower margin products in LCT and a slightly lower portion of sales recorded from ecommerce compared with other sales channels for LSC for the periods in question.

Research and development expenses were $1.41 million for the three months ended June 30, 2014, compared to $974,000 for the same period in 2013. The increase of $437,000 or 45% is primarily due to increased stem cell line research and testing expenses. Research and development expenses for the six months ended, June 30, 2014 were $2.37 million, compared to $1.70 million for the same period in 2013. The increase of $674,000 or 40% was primarily due to higher stem cell line research and testing expenses of $816,000.

Selling and marketing expenses for the three months ended June 30, 2014 were $679,000, approximating the same amount as the corresponding period in 2013. Selling and marketing expenses for the six months ended June 30, 2014 were $1.35 million, compared to $1.19 million in the six months ended June 30, 2013 reflecting an increase of $157,000 or 13%. The increase in spending was primarily due to increased employee-related spending, consulting expenses, and expenses for marketing materials, samples and printing related to the Lifeline Skincare subsidiary.

General and administrative expenses for the three months ended June 30, 2014 were $1.33 million, reflecting a decrease of $333,000 or 20%, compared to $1.67 million for the same period in 2013. General and administrative expenses for the six months ended June 30, 2014 were $2.98 million, reflecting a decrease of $117,000 or 4%, compared to $3.10 million for the same period in 2013.

As of June 30, 2014, our cash and cash equivalents totaled $748,000, compared to $2.24 million as of December 31, 2013. At June 30, 2014, we had a working capital balance of $1.17 million, compared to a $2.40 million deficit as of December 31, 2013. The positive change in our working capital from a deficit at December 31, 2013 is primarily due to removal of the fair value of warrant liability from our balance sheet as of the end of the current quarter upon the exchange of warrants for common stock with investors.

Net cash provided by financing activities was $2.42 million for the six months ended June 30, 2014, compared to $3.27 million in the same period in 2013. Approximately $1.42 million of the net proceeds of $2.42 million received in 2014 was attributable to the issuance of 8.2 million shares of common stock, net of stock issuance costs of $169,000 under the purchase agreement with Lincoln Park Capital, LLC (“Lincoln Park”), which we entered into in December 2013. In addition, we received net proceeds of $1.1 million from the sale of 8.8 million shares to Dr. Andrey Semechkin, our Co-Chairman and Chief Executive Officer and Dr. Ruslan Semechkin our Chief Scientific Officer and a director.

Management is currently evaluating various financing sources and options to raise working capital to help fund our current research and development programs and operations. We will need to obtain significant additional capital from sources including equity and/or debt financings, license arrangements, grants and/or collaborative research arrangements to sustain our operations and develop products. Thereafter, we will need to raise additional working capital.

Date: Tuesday, August 12, 2014
Time: 11:00 a.m. Eastern Time
Conference Number (U.S.): 1-888-572-7034
International Dial-In: 1-719-325-2455
Conference ID: 3065653
Webcast: http://public.viavid.com/player/index.php?id=110446

Please dial in at least 10-minutes before the call to ensure timely participation.

A playback of the call will be available from 08/12/14 at 2:00 pm ET until 08/26/14 at 11:59 pm ET. To listen, call 1-877-870-5176 within the United States or 1-858-384-5517 when calling internationally. Please use the replay pin number 3065653.

About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

Forward-looking Statements
Statements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.




Contacts:
International Stem Cell Corporation
Dr. Simon Craw, Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com

Mr. Jay Novak, Chief Financial Officer
Phone: 760-940-6383
Email: jnovak@intlstemcell.com


International Stem Cell Corporation and Subsidiaries             
                   Condensed Consolidated Balance Sheets                    
                     (in thousands, except share data)                      

                                                   June 30,    December 31, 
                                                     2014          2013     
                                                 ------------  ------------ 
                                                  (Unaudited)               
Assets                                                                      
  Cash and cash equivalents                      $        748  $      2,243 
  Accounts receivable, net of allowance for                                 
   doubtful accounts of $19 at June 30, 2014 and                            
   December 31, 2013                                      406           306 
  Inventory, net                                        1,470         1,369 
  Prepaid expenses and other current assets               539           658 
  Restricted cash                                          50            50 
                                                 ------------  ------------ 
    Total current assets                                3,213         4,626 
  Property and equipment, net                             847           830 
  Intangible assets, net                                2,522         2,250 
  Deposits and other assets                                33            33 
                                                 ------------  ------------ 
    Total assets                                 $      6,615  $      7,739 
                                                 ============  ============ 
Liabilities, Redeemable Preferred Stock and                                 
 Stockholders' Deficit                                                      
  Accounts payable                               $        798  $        532 
  Accrued liabilities                                     960         1,290 
  Deferred revenue                                          -             3 
  Related party payable                                    31            21 
  Advances                                                250           250 
  Fair value of warrant liability                           -         4,925 
                                                 ------------  ------------ 
    Total current liabilities                           2,039         7,021 
                                                 ------------  ------------ 
Convertible Redeemable Series G Preferred stock,                            
 $0.001 par value, 5,000,000 shares authorized,                             
 issued and outstanding at June 30, 2014 and                                
 December 31, 2013, liquidation preference of                               
 $5,000 at June 30, 2014 and December 31, 2013          4,941         4,941 
Commitments and contingencies                                               
Stockholders' Deficit                                                       
Series D Preferred stock, $0.001 par value, 50                              
 shares authorized, 43 issued and outstanding at                            
 June 30, 2014 and December 31, 2013, with                                  
 liquidation preference of $4,320 at June 30,                               
 2014 and December 31, 2013                                 -             - 
Series B Preferred stock, $0.001 par value,                                 
 5,000,000 shares authorized, 300,000 issued and                            
 outstanding at June 30, 2014 and December 31,                              
 2013, with liquidation preferences of $412 and                             
 $403 at June 30, 2014 and December 31, 2013,                               
 respectively                                               -             - 
Common stock, $0.001 par value, 600,000,000 and                             
 300,000,000 shares authorized, 213,590,669 and                             
 151,175,053 shares issued and outstanding at                               
 June 30, 2014 and December 31, 2013,                                       
 respectively                                             214           151 
Additional paid-in capital                             87,537        77,897 
Accumulated deficit                                   (88,116)      (82,271)
                                                 ------------  ------------ 
    Total stockholders' deficit                          (365)       (4,223)
                                                 ------------  ------------ 
    Total liabilities, redeemable preferred                                 
     stock and stockholders' deficit             $      6,615  $      7,739 
                                                 ============  ============ 





           International Stem Cell Corporation and Subsidiaries             
              Condensed Consolidated Statements of Operations               
                   (in thousands, except per share data)                    
                                (Unaudited)                                 

                                  Three Months Ended     Six Months Ended   
                                       June 30,              June 30,       
                                 --------------------  -------------------- 
                                    2014       2013       2014       2013   
                                 ---------  ---------  ---------  --------- 
Revenues                                                                    
  Product sales                  $   1,588  $   1,457  $   3,237  $   2,742 
                                 ---------  ---------  ---------  --------- 
    Total revenue                    1,588      1,457      3,237      2,742 
                                 ---------  ---------  ---------  --------- 
Expenses                                                                    
  Cost of sales                        409        329        848        663 
  Research and development           1,411        974      2,369      1,695 
  Selling and marketing                679        679      1,348      1,191 
  General and administrative         1,332      1,665      2,980      3,097 
                                 ---------  ---------  ---------  --------- 
    Total expenses                   3,831      3,647      7,545      6,646 
                                 ---------  ---------  ---------  --------- 
Loss from operating activities      (2,243)    (2,190)    (4,308)    (3,904)
                                 ---------  ---------  ---------  --------- 
Other income (expense)                                                      
  Change in fair value of                                                   
   warrant liability                 1,271          -      1,894          - 
  Warrant exchange inducement                                               
   expense                          (3,445)         -     (3,445)         - 
  Miscellaneous expense                  -        (18)         -        (20)
  Interest expense                      (1)        (1)        (2)        (2)
  Sublease income                        8          9         16         13 
                                 ---------  ---------  ---------  --------- 
    Total other income                                                      
     (expense), net                 (2,167)       (10)    (1,537)        (9)
                                 ---------  ---------  ---------  --------- 
Loss before income taxes            (4,410)    (2,200)    (5,845)    (3,913)
Provision for income taxes               -          -          -          - 
                                 ---------  ---------  ---------  --------- 
    Net loss                     $  (4,410) $  (2,200) $  (5,845) $  (3,913)
                                 =========  =========  =========  ========= 

Net loss applicable to common                                               
 stockholders                    $  (4,410) $  (2,200) $  (5,845) $  (3,913)
                                 =========  =========  =========  ========= 

Net loss per common share-basic                                             
 and diluted                     $   (0.03) $   (0.02) $   (0.04) $   (0.04)
                                 =========  =========  =========  ========= 

Weighted average shares-basic                                               
 and diluted                       170,632    112,410    162,108    108,013 
                                 =========  =========  =========  ========= 


International Stem Cell Corporation Launches Stroke Program with Tulane University

CARLSBAD, CA - (Marketwired, August 5, 2014) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based biotechnology company developing novel stem cell based therapies, announced today that it has launched a new Stroke Program.  Together with Tulane University, ISCO will study the impact of human parthenogenetic neural stem cells (hpNSC) transplantation in a pre-clinical rodent model of ischemic stroke as a first step toward the clinical development of a potential stroke treatment. The proof-of-concept study will be done in the laboratory of Dr. Jean-Pyo Lee, a well-known expert in the field of regenerative medicine.
“Evaluating our human neural stem cells for treatment of stroke is a logical next step,” said Dr. Andrey Semechkin, ISCO’s Co-Chairman and CEO, “as it should allow us to get a lot of additional value from the safety studies performed for the Parkinson’s disease program and advance the possibility of treating another largely unmet medical need. We expect to provide an update on the stroke study in Q4 2014. At the same time, our Parkinson’s disease program of course remains our top priority.”
Although stroke is known to cause long-term neurological disability, there is evidence that transplantation of NSC may improve patient outcomes as an adjunctive therapeutic strategy.  ISCO’s new stroke program will use the same cellular product as the Parkinson’s disease program.  There is significant overlap in the safety datasets and manufacturing methods that would be required to file an IND for stroke, making it a logical follow-on indication. hpNSC generated from ISCO’s propriety human parthenogenetic stem cells using a cGMP method based on the published protocol are already under development for the treatment of Parkinson’s disease.  The Company has a considerable amount of safety data on hpNSC from the previously discussed studies in the Parkinson’s program that are designed to support the planned IND filing, including evidence from the primate studies that these cells can reduce brain inflammation.  
According to the National Stroke Association stroke is a leading cause of death In the United States, killing nearly 130,000 people each year, and a leading cause of serious, long-term adult disability.  Approximately 795,000 strokes will occur each year, one occurring every 40 seconds, and taking a life approximately every four minutes.  About 87% of strokes are ischemic.  Approximately two million brain cells die every minute during stroke, increasing the risk of permanent brain damage, disability or death.  The estimated direct and indirect cost of stroke in the United States in 2010 is $73.7 billion. 
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCellTM. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell
Contacts:
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383

Dr. Ruslan Semechkin
Chief Scientific Officer
Phone: 760-940-6383

Email: ras@intlstemcell.com