HemaCare Corporation (OTCMKTS: HEMA), a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cellular process development, today announced operational highlights and financial results for the six months ended June 30, 2019.

First Half 2019 Operational Highlights

  • Product and services revenue growth was primarily due to customized cell isolation, processing and cryopreservation, specialized collection of leukopaks and mobilized peripheral blood. No revenues have been attributed to GMP clean room operations, although ~$500,000 of clean room one-time only startup costs were incurred during the reporting period.
  • Further enabled scalability by launching automated systems to support and streamline Quality Assurance, Purchasing, and Human Resources.
  • In January, at the Phacilitate Cell & Gene Therapy World Conference, HemaCare partnered with Hitachi Chemical Advanced Therapeutics Solutions (HCATS) on a presentation titled, “Improved Stability and Quality of Donor Starting Material.” This was followed up in February with a joint webinar hosted with HCATS titled, “Managing Starting Material Stability to Maximize Manufacturing Flexibility & Downstream Efficiency.”
  • In February, HemaCare executed a strategic collaboration with a long-time global distributor, Tissue Solutions. This strategic collaboration expands the disease state product portfolio for HemaCare clients and leverages Tissue Solutions’ expertise in sourcing these critical materials.
  • On April 4, 2019, HemaCare executed a lease for an additional 13,300 square feet of contiguous space to accommodate GMP project management and Quality Assurance personnel necessary to support GMP project demand.
  • In May, HemaCare executed a distributor agreement with FujiFilm (Wako Pure Chemical Corporation) for distribution of its cryopreserved products in Japan. This agreement will further drive growth in this rapidly expanding research market.
  • In July, HemaCare announced a branding initiative around HemaPrime™(research use) and GMPrime™(GMP-compliant) cells and tissues, providing clients with access to the premium quality materials needed to support research from bench to commercialization.

Financial Results

  • For the six months ended June 30, 2019, total revenues of $19.5 million, compared to $13.1 million for the six months ended June 30, 2018, representing an increase of $6.4 million, or approximately 49%.
  • Gross profit for the six months ended June 30, 2019 of $10.2 million, or 53% of net revenues, compared to $7.4 million, or 57% of net revenues, for the six months ended June 30, 2018. The decrease in year-over-year margin is attributed to HemaCare’s new facility relocation and resulting increased depreciation and amortization of property and equipment and one-time only GMP related clean room startup costs.
  • EBITDA, a non-GAAP measurement, for the six months ended June 30, 2019 of $4.7 million compared with $3.1 million for the same period in 2018, representing an increase of $1.6 million or 51%.
  • Net income for the six months ended June 30, 2019, increased to $4.5 million, as compared to $2.1 million for the prior-year period, including an income tax net benefit of $353,000 primarily derived from a corporate tax deduction for the exercise of non-qualified stock options which offsets tax expense.
  • Capital expenditures increased by $900,000 for the six months ended June 30, 2019 primarily due to investment in HemaCare’s Donor Center and Biorepository.
  • As of June 30, 2019, HemaCare had $10.9 million in cash and cash equivalents compared to $10.3 million at June 30, 2018.

For complete unaudited First Half 2019 Financial Statements, please click here.

Pete van der Wal, HemaCare’s President and Chief Executive stated: “We continue to strengthen our position as the trusted brand and global leader in the production and customization of the highest quality human-derived cellular products for research, drug discovery, development and commercial production of cell and gene therapies.”

“HemaCare is committed to the highest levels of quality and regulatory compliance in the industry. We maintain rigorous ongoing training programs for our team, and comprehensive validation programs of our facility, equipment, and processes to ensure customers receive consistent, high-quality products and services. Our quality system is based on strict regulatory requirements and industry best practices,” said van der Wal.

HEMACARE CORPORATION
BALANCE SHEETS
       
ASSETS
 (unaudited)   (audited)
 June 30, 2019   December 31, 2018
CURRENT ASSETS      
Cash and cash equivalents  

$

10,913,000

   

$

10,274,000

 

Accounts receivable, net  

 

6,768,000

   

 

4,776,000

 

Product inventories and supplies, net  

 

3,954,000

   

 

3,299,000

 

Prepaid expenses  

 

316,000

   

 

239,000

 

Other current assets  

 

939,000

   

 

141,000

 

       
TOTAL CURRENT ASSETS  

 

22,890,000

   

 

18,729,000

 

       
OTHER ASSETS      
Property and equipment, net  

 

9,764,000

   

 

9,502,000

 

Deferred income taxes  

 

116,000

   

 

-

 

       
TOTAL NONCURRENT ASSETS  

 

9,880,000

   

 

9,502,000

 

       
TOTAL ASSETS  

$

32,770,000

   

$

28,231,000

 

       
LIABILITIES AND SHAREHOLDERS' EQUITY
       
CURRENT LIABILITIES      
Accounts payable  

$

1,815,000

   

$

2,184,000

 

Accrued payroll and payroll taxes  

 

1,578,000

   

 

1,979,000

 

Other accrued expenses  

 

127,000

   

 

123,000

 

Current portion of capital lease obligations  

 

185,000

   

 

201,000

 

       
TOTAL CURRENT LIABILITIES  

 

3,705,000

   

 

4,487,000

 

       
LONG-TERM LIABILITIES      
Deferred rent  

 

2,534,000

   

 

2,409,000

 

Deferred income taxes  

 

-

   

 

35,000

 

Long-term portion of capital lease obligations  

 

84,000

   

 

176,000

 

       
TOTAL LONG-TERM LIABILITIES  

 

2,618,000

   

 

2,620,000

 

       
TOTAL LIABILITIES  

 

6,323,000

   

 

7,107,000

 

       
       
SHAREHOLDERS' EQUITY      
Common stock, no par, 40,000,000 shares authorized,      
13,657,206 and 12,860,956 shares issued and outstanding, respectively  

 

23,909,000

   

 

23,060,000

 

Retained earnings (accumulated deficit)  

 

2,538,000

   

 

(1,936,000

)

       
TOTAL SHAREHOLDERS' EQUITY  

 

26,447,000

   

 

21,124,000

 

       
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY  

$

32,770,000

   

$

28,231,000

 

HEMACARE CORPORATION

STATEMENTS OF INCOME

(unaudited)

       
 Six months ended   Six months ended
 June 30, 2019   June 30, 2018
       
REVENUE  

$

19,454,000

   

$

13,070,000

 

       
COST OF REVENUE  

 

9,236,000

   

 

5,638,000

 

       
GROSS PROFIT  

 

10,218,000

   

 

7,432,000

 

       
GENERAL AND ADMINISTRATIVE EXPENSES  

 

6,148,000

   

 

4,509,000

 

       
OTHER INCOME (EXPENSE)  

 

51,000

   

 

(3,000

)

       
INCOME BEFORE INCOME TAX BENEFIT (EXPENSE)  

 

4,121,000

   

 

2,920,000

 

       
Income tax benefit (expense)  

 

353,000

   

 

(790,000

)

       
NET INCOME  

$

4,474,000

   

$

2,130,000

 

       

About HemaCare

HemaCare is a global leader in the customization of human-derived biological products and services for biomedical research, drug discovery, and cellular therapy process development. The company’s network of FDA-registered, GMP/GTP-compliant collection centers ensure fresh donor material is available to customers and for use within HemaCare’s isolation laboratory. Human biological material including peripheral blood, bone marrow, and cord blood is isolated into various primary cells types for fresh and frozen distribution. For over 40 years, HemaCare has developed an extensive registry of repeat donors and provides human-derived primary blood cells and tissues for biomedical and drug discovery research and cell therapy clinical trials, and supports commercialization with apheresis collections, directly enabling customers to advance both autologous and allogeneic cellular therapies.

For more information please visit www.hemacare.com.

Forward Looking Statements

This press release contains forward-looking statements. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, including, without limitation, the following: the ability of our donors to provide sufficient quality source material; our ability and the ability of our suppliers to maintain compliance with cGMP and other regulatory obligations; the results of regulatory inspections; adverse developments in our customer-base or the markets we serve; results of the Company’s collaboration with strategic partners; adverse changes in regulatory, social and political conditions affecting our industry; our ability to timely and effectively implement 2019 staffing, operations, and product menu changes; our ability to manage growth; and general market, economic and business conditions. Forward-looking statements are made as of the date of this release, and we expressly disclaim any obligation or undertaking to update forward-looking statements.