0001193125-16-580958.txt : 20160506 0001193125-16-580958.hdr.sgml : 20160506 20160506080302 ACCESSION NUMBER: 0001193125-16-580958 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20160506 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160506 DATE AS OF CHANGE: 20160506 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CareDx, Inc. CENTRAL INDEX KEY: 0001217234 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 943316839 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36536 FILM NUMBER: 161625916 BUSINESS ADDRESS: STREET 1: 3260 BAYSHORE BOULEVARD CITY: BRISBANE STATE: CA ZIP: 94005 BUSINESS PHONE: 415-287-2300 MAIL ADDRESS: STREET 1: 3260 BAYSHORE BOULEVARD CITY: BRISBANE STATE: CA ZIP: 94005 FORMER COMPANY: FORMER CONFORMED NAME: XDx, Inc. DATE OF NAME CHANGE: 20071010 FORMER COMPANY: FORMER CONFORMED NAME: EXPRESSION DIAGNOSTICS INC DATE OF NAME CHANGE: 20030203 8-K 1 d157692d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 6, 2016

 

 

CAREDX, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36536   94-3316839

(State or other jurisdiction

of incorporation)

 

(Commission

File No.)

 

(IRS Employer

Identification Number)

3260 Bayshore Boulevard

Brisbane, California 94005

(Address of principal executive offices)

(415) 287-2300

(Registrant’s telephone number, including area code)

 

 

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))

 

 

 


ITEM 2.02. Results of Operations and Financial Conditions

On May 6, 2016, CareDx, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2016. In the press release, the Company also announced that it would be holding a conference call on May 6, 2016 to discuss its financial results for the quarter ended March 31, 2016. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

On May 6, 2016, Allenex AB (“Allenex”), having recently been acquired by the Company, also issued a press release announcing its financial results for the quarter ended March 31, 2016. In the press release, Allenex also announced that it would participate in Company’s conference call on May 6, 2016 and discuss its financial results for the quarter ended March 31, 2016. The full text of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

In addition to historical information, the Allenex press release contains forward-looking statements with respect to Allenex’s business, research, development and commercialization efforts and anticipated future financial results. These forward-looking statements are based upon information that is currently available to Allenex and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including the risk that its revenue may not be as high as anticipated, risks related to a successful integration following its acquisition by the Company, risks relating to its dependence on distribution agreements –and the cooperation required from those distribution partners—in various global locations, risks of increased competition from other market participants, many of whom have substantially greater resources than Allenex and the Company, and risks related to the development and commercialization of additional genomic HLA typing solutions in an evolving marketplace. These factors, together with those that are described in greater detail in Allenex’s press releases, including the Allenex Annual Report for the fiscal year ended December 31, 2015, may cause its actual results, performance or achievements to differ materially and adversely from those anticipated or implied by its forward-looking statements. Allenex and the Company expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements. Allenex’s results for the most recent reporting period are not necessarily indicative of its operating results for any future periods.

This information is intended to be furnished under Item 2.02 and Item 9.01 of Form 8-K, “Results of Operations and Financial Condition” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

ITEM 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit
No.

  

Description

99.1    Press release issued by CareDx, Inc. dated May 6, 2016
99.2    Press release issued by Allenex AB dated May 6, 2016


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.

 

    CAREDX, INC.
Date: May 6, 2016      
    By:  

/s/ Charles Constanti

      Charles Constanti
      Chief Financial Officer


EXHIBIT INDEX

 

Exhibit
No.

  

Description

99.1    Press release issued by CareDx, Inc. dated May 6, 2016
99.2    Press release issued by Allenex AB dated May 6, 2016
EX-99.1 2 d157692dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

CareDx, Inc. Reports First Quarter 2016 Financial Results

Brisbane, CA — May 6, 2016—CareDx, Inc. (Nasdaq: CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today reported financial results for the first quarter ended March 31, 2016.

Recent Highlights

 

    Total revenue for the first quarter of 2016 was $6.6 million

 

    Completed acquisition of Allenex AB, creating an international transplant diagnostics company

 

    Increased AlloMap patient results volume by 8% in the first quarter of 2016 compared with the same period in 2015

 

    Built further momentum on AlloMap Variability with 41 centers now receiving longitudinal test results on a regular basis

 

    Expanded AlloMap registry (OAR) now established in 28 centers

 

    Participated at the International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting with a total of 8 clinical abstracts

 

    Continued progress on the development of cell-free DNA with DART with 359 patients enrolled at 14 centers

 

    Raised $14 million gross proceeds in a private placement with an additional $8 million committed

“We’ve accomplished much to start 2016, highlighted by the closing of the acquisition of Allenex. This combination positions us as a leader across the pre-to post-transplant continuum,” said Peter Maag, CareDx President and Chief Executive Officer. “We are pleased with the underlying AlloMap test growth and are focused on execution of our initiatives to reverse the timing lag in our reimbursement collections.”

First Quarter Financial Results

Revenue for the three months ended March 31, 2016 was $6.6 million, compared with $7.2 million in the same period in 2015. Test volume increased approximately 8% for the first quarter of 2016 compared with the first quarter of 2015. The revenue trend reflects a continued lag in collections, which impacted revenue recognized on a cash basis following the transition of billings and collections from an outside vendor to an in-house team.


For the first quarter of 2016, the net loss was $9.8 million compared to net loss of $2.3 million in the first quarter of 2015. Basic and diluted net loss per share was $0.81 in the first quarter of 2016, compared to basic and diluted net loss per share of $0.19 in the first quarter of 2015. The increase in the year-over-year net loss reflects acquisition costs, financing charges, and our investment in the development of AlloSure™, a next-generation sequencing–based test to detect donor-derived cell-free DNA after transplantation.

With the acquisition of Allenex AB in April 2016, CareDx has become a significantly larger and more complex Company that will be subject to acquisition accounting and has incurred and will continue to incur costs connected with completing the acquisition, integration and management of a global company. As described and defined below under the caption, “Use of Non-GAAP Financial Measures”, management has begun to use non-GAAP information internally for its operating, budgeting and financial planning purposes. Management is herein reporting non-GAAP financial measures and believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx’s GAAP financial statements.

For the first quarter of 2016, the non-GAAP net loss was $4.4 million compared to net loss of $2.2 million in the first quarter of 2015. The non-GAAP basic and diluted net loss per share was $0.37 in the first quarter of 2016, compared to basic and diluted earnings per share of $0.19 in the first quarter of 2015. The increase in the year-over-year non-GAAP net loss reflects our investment in the development of AlloSure™, a next-generation sequencing–based test to detect donor-derived cell-free DNA after transplantation. For additional information regarding non-GAAP financial measures discussed herein, please see “Use of Non-GAAP Financial Measures” and “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

Cash and cash equivalents were $23.8 million as of March 31, 2016.

2016 Guidance

For the full year 2016, we expect revenue to grow by low- to mid-single digits on a pro forma basis, assuming that the Allenex acquisition closed at the beginning of 2016. Actual reported results will only include Allenex results subsequent to the close of the acquisition on April 14, 2016, and we expect reported revenue for the full year 2016 to be in the range of $40 million to $42 million.

Conference Call

Management will host a conference call today beginning at 5:30am PT/8:30am ET. Individuals interested in listening to the conference call may do so by dialing (855) 420-0616 for domestic callers or (678) 304-6848 for international callers. Please reference Conference ID 96537271. To listen to a live webcast, please visit the investor relations section of CareDx’s website at: www.CareDx.com.


A replay of the call will be available beginning May 6, 2016 at 8:30am PT/11:30am ET through 8:30 pm PT/11:30pm ET on May 7, 2016. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 96537271. The webcast will also be available on CareDx’s website for one year following the completion of the call.

About CareDx

CareDx, Inc., headquartered in Brisbane, California, is a global molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients. The Company markets AlloMap®, a gene expression test that aids clinicians in identifying heart transplant patients with stable graft function who have a low probability of moderate to severe acute cellular rejection. CareDx is pursuing the development of additional products for transplant monitoring using a variety of technologies, including AlloSure™, a next-generation sequencing–based test to detect donor-derived cell-free DNA after transplantation.

CareDx’s, with its presence through Olerup AB, also develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. Olerup SSP®, a set of HLA typing is used prior to hematopoietic stem cell/bone marrow transplantation and organ transplantation; and XM-ONE®, the first standardized test that quickly identifies a patient’s antigens against HLA Class I, Class II or antibodies against a donor’s endothelium. For more information, please visit: www.CareDx.com.

Forward Looking Statements

In addition to the historical information, this press release contains forward-looking statements with respect to our business, research, development and commercialization efforts and anticipated future financial results. These forward-looking statements are based upon information that is currently available to us and our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including the risk that our revenue or non-GAAP financial metrics may not be as high as anticipated, risks related to the successful integration of Allenex AB and Olerup SSP into our product line, risks relating to our dependence on the sales of one test, AlloMap, for substantially all of our current revenue, our dependence on Medicare for a substantial portion of our revenue, our dependence on health insurers and other third-party payers to provide coverage for our current test and future tests, if any, risks of increased competition from other market participants, many of whom have substantially greater resources than us and risks related to our development and commercialization of additional diagnostic solutions. These factors, together with those that are described in our filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2015 filed by us with the SEC on March 29, 2016, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation,


except as required by law, or undertaking to update or revise any such forward-looking statements. Additional information will also be set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. Our results for the most recent reporting period are not necessarily indicative of our operating results for any future periods.

Use of Non-GAAP Financial Measures

CareDx has presented certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis in this release, including non-GAAP net loss and non-GAAP basic and diluted net loss per share. We define non-GAAP net loss and per share results as the GAAP net loss and per share results excluding the impacts of stock-based compensation, changes in estimated fair value of contingent consideration, costs involved with completing an acquisition, and certain financing charges. We are presenting these non-GAAP financial measures to assist investors in assessing our operating results through the eyes of management, and because we believe that these measures provide an additional tool for investors to use in comparing our core business operating results over multiple periods. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of CareDx’s operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly-titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables.

 

Media Contacts – CareDx   Media Contacts - Investor
Molly Martell, Senior Director, Marketing   Jamar Ismail, Vice President
T: +1 415-728-6307   Westwicke Partners, LLC
E: mmartell@caredx.com   T: +1 415-513-1282
  E: jamar.ismail@westwicke.com


CareDx, Inc.

Condensed Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

     Three Months Ended March 31,  
     2016     2015  

Revenue:

    

Testing revenue

   $ 6,452      $ 7,096   

Collaboration, license and other revenue

     110        120   
  

 

 

   

 

 

 

Total revenue

     6,562        7,216   

Operating expenses:

    

Cost of testing

     2,772        2,711   

Research and development

     3,159        1,421   

Sales and marketing

     1,737        2,023   

General and administrative

     5,676        2,705   

Change in estimated fair value of contingent consideration

     (213     (253
  

 

 

   

 

 

 

Total operating expenses

     13,131        8,607   
  

 

 

   

 

 

 

Loss from operations

     (6,569     (1,391

Interest expense

     (266     (827

Other (expense) income, net

     (2,917     (54
  

 

 

   

 

 

 

Net loss

   $ (9,752   $ (2,272
  

 

 

   

 

 

 

Net loss per share:

    

Basic and diluted

   $ (0.81   $ (0.19
  

 

 

   

 

 

 

Weighted average shares used to compute net loss per share:

    

Basic and diluted

     11,969,714        11,814,467   
  

 

 

   

 

 

 


CareDx, Inc.

Condensed Balance Sheets

(Unaudited)

(In thousands, except share and per share data)

 

     March 31, 2016     December 31, 2015 (1)  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 23,752      $ 29,888   

Accounts receivable

     2,512        2,367   

Inventory

     595        766   

Prepaid and other assets

     807        1,341   
  

 

 

   

 

 

 

Total current assets

     27,666        34,362   

Property and equipment, net

     2,346        2,425   

Intangible assets, net

     6,650        6,650   

Goodwill

     12,005        12,005   

Restricted cash

     147        147   

Other noncurrent assets

     20        49   
  

 

 

   

 

 

 

Total assets

   $ 48,834      $ 55,638   
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 2,536      $ 1,644   

Accrued payroll liabilities

     1,609        2,366   

Accrued and other liabilities

     5,298        2,892   

Accrued royalties

     232        242   

Deferred revenue

     137        142   

Current portion of long-term debt

     4,419        2,866   
  

 

 

   

 

 

 

Total current liabilities

     14,231        10,152   

Deferred rent, net of current portion

     1,347        1,426   

Deferred revenue, net of current portion

     693        703   

Long-term debt, net of current portion

     11,368        12,887   

Contingent consideration

     735        948   

Other liabilities

     —          28   
  

 

 

   

 

 

 

Total liabilities

     28,374        26,144   

Stockholders’ equity:

    

Common stock

     12        12   

Additional paid-in capital

     203,284        202,564   

Accumulated deficit

     (182,836     (173,082
  

 

 

   

 

 

 

Total stockholders’ equity

     20,460        29,494   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 48,834      $ 55,638   
  

 

 

   

 

 

 

 

(1) The condensed balance sheet at December 31, 2015 has been derived from audited financial statements.


CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands, except share and per share data)

 

     Three Months Ended March 31,  
     2016     2015  

Cost of testing reconciliation:

    

GAAP cost of testing

   $ 2,772      $ 2,711   

Stock-based compensation expense

     (28     (14
  

 

 

   

 

 

 

Non-GAAP cost of testing

   $ 2,744      $ 2,697   
  

 

 

   

 

 

 

Research and development expenses reconciliation:

    

GAAP research and development expenses

   $ 3,159      $ 1,421   

Stock-based compensation expense

     (113     (49
  

 

 

   

 

 

 

Non-GAAP research and development expenses

   $ 3,046      $ 1,372   
  

 

 

   

 

 

 

Sales and marketing expenses reconciliation:

    

GAAP sales and marketing expenses

   $ 1,737      $ 2,023   

Stock-based compensation expense

     (28     (18
  

 

 

   

 

 

 

Non-GAAP sales and marketing expenses

   $ 1,709      $ 2,005   
  

 

 

   

 

 

 

General and administrative expenses reconciliation:

    

GAAP general and administrative expenses

   $ 5,676      $ 2,705   

Acquisition related fees and expenses

     (2,259     —     

Stock-based compensation expense

     (277     (199
  

 

 

   

 

 

 

Non-GAAP general and administrative expenses

   $ 3,140      $ 2,506   
  

 

 

   

 

 

 

Change in estimated fair value of contingent consideration reconciliation:

    

GAAP change in estimated fair value of contingent consideration

   $ (213   $ (253

Revaluation gain of contingent consideration

     213        253   
  

 

 

   

 

 

 

Non-GAAP change in estimated fair value of contingent consideration

   $ —        $ —     
  

 

 

   

 

 

 

Other (expense) income, net reconciliation:

    

GAAP other (expense) income, net

   $ (2,917   $ (54

Debt financing related fees and expenses

     2,879        —     
  

 

 

   

 

 

 

Non-GAAP other (expense) income, net

   $ (38   $ (54
  

 

 

   

 

 

 

Net loss reconciliation:

    

GAAP net loss

   $ (9,752   $ (2,272

Acquisition related fees and expenses

     2,259        —     

Debt financing related fees and expenses

     2,879        —     

Stock-based compensation expenses

     446        280   

Revaluation gain of contingent consideration

     (213     (253
  

 

 

   

 

 

 

Non-GAAP net loss

   $ (4,381   $ (2,245
  

 

 

   

 

 

 

Basic and diluted net loss per share reconciliation:

    

GAAP basic and diluted net loss per share

   $ (0.81   $ (0.19

Acquisition related fees and expenses

     0.19        —     

Debt financing related fees and expenses

     0.24        —     

Stock-based compensation expenses

     0.03        0.02   

Revaluation gain of contingent consideration

     (0.02     (0.02
  

 

 

   

 

 

 

Non-GAAP basic and diluted net loss per share

   $ (0.37   $ (0.19
  

 

 

   

 

 

 

Non-GAAP adjustment summary:

    

Cost of testing adjustments

   $ 28      $ 14   

Research and development expenses adjustments

     113        49   

Sales and marketing expenses adjustments

     28        18   

General and administrative expenses adjustments

     2,536        199   

Change in estimated fair value of contingent consideration adjustments

     (213     (253

Other expense adjustments

     2,879        —     
  

 

 

   

 

 

 

Total Non-GAAP adjustment summary:

   $ 5,371      $ 27   
  

 

 

   

 

 

 
EX-99.2 3 d157692dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

LOGO

ALLENEX AB (PUBL)

INTERIM REPORT JANUARY - MARCH 2016

For the January-March period

 

    Net sales for the period totaled SEK 32.6 million (33.7).

 

    Operating profit (EBIT) for the period was SEK 1.7 million (5.8).

 

    Operating margin for the period was 5 percent (17).

 

    Earnings after tax for the period amounted to SEK 0.4 million (5.5).

 

    Earnings per share, basic and diluted for the period was SEK 0.00 (0.05).

Significant events in the first quarter and after the end of the reporting period

 

    On February 9, 2016, CareDx, Inc. announced revised terms of its offer to the shareholders of Allenex AB. The Board of Directors’ recommendation to the shareholders of Allenex to accept the offer remained unchanged.

 

    On April 8, 2016, CareDx, Inc. announced that the offer to the shareholders of Allenex AB had been accepted by shareholders representing a total of 118 207 862 shares, equivalent to around 98.3 percent of the number of outstanding shares, and that the offer is unconditional. CareDx intends to initiate compulsory acquisition of the remaining shares in the company and in conjunction with this will push for the share to be delisted from NASDAQ Stockholm.

President and CEO Anders Karlsson’s commentary on the first quarter 2016:

“We continue to see an increase in sales in the USA, which was up more than 10 percent in the first quarter compared to last year. It is gratifying that the investments in market development that we initiated two years ago continue to drive sales in the company’s single largest market. Although revenues and EBIT were down overall, it should be noted that the first quarter 2015 was unusually strong and that Easter this year was in the month of March. After the end of the reporting period, CareDx Inc. completed the acquisition of Allenex. The combined company will be able to offer a strong portfolio of diagnostic products benefitting transplantation both before and after the transplant.”

 

For more information, please contact:

Anders Karlsson, CEO, tel:+46(0)70 918 00 10 or email: anders.karlsson@allenex.se

 

1 (11)


LOGO

 

OPERATIONS

Allenex is a life science company that develops, manufactures, markets and sells products on the global market that facilitate safer transplantation of blood stem cells and organs. Allenex is listed on NASDAQ OMX Stockholm, Small Cap, (ticker: ALNX). On April 14, 2016, Allenex became a subsidiary of CareDx Inc. There are 57 persons employed in Allenex including subsidiaries.

SALES

Net sales for the first quarter amounted to SEK 32.6 million (33.7), corresponding to a decrease of around three percent compared to the same period last year. The assessment is that this discrepancy is caused by variability between different quarters, both this year and last year.

 

 

LOGO

North American continues to increase in importance for Allenex, accounting for 30 percent of Allenex total sales for the quarter, while the corresponding figure for the first quarter 2015 was 25.5 percent. Growth in this region is primarily driven by new customers in the SBT segment, however, sales of SSP products also contributed positively. Sales in North America in the first quarter increased by 11 percent in local currency (USD) compared to the same period last year.

Sales in Europe decreased by seven percent in local currency compared to the first quarter 2015, which was unusually strong. However, in Poland, Belgium and Turkey, for example, the first quarter 2016 was strong, particularly for traditional SSP products, while other countries, such as Italy and Germany had a somewhat weaker start to the year. India and China, both developing markets, showed lower sales for the quarter than the same period last year.

The validation process tends to be relatively long, usually taking from 6 to 15 months. At the period end, 44 laboratories had converted, partially or fully, to SBT Resolver™ (25 in North American and 19 in Europa/Asia), and a number of laboratories at the validation stage.

LOGO

Allenex products are distributed via direct sales through a proprietary sales organization in key markets such as the USA, Germany and in the Nordic region. They are also distributed via partnerships with local distributors in other markets. Registration processes are ongoing for the company’s products in a number of countries, with work underway to secure strong local sales/distribution partners in these markets. This has intensified in that the competitors One Lambda and Life Technologies, which were acquired by Thermo Fisher Scientific in recent years, have now chosen to consolidate their operations to one distributor in certain markets.

CUSTOMER GROUPS

Allenex customers largely constitute laboratories active in transplantation diagnostics. Today, there are three different technologies on the market for HLA typing (SSP, SSO and SBT), where the most common typing method globally, in terms of volume, is SSO. However, most laboratories use SSP typing, either as a primary or supplementary method. The size of the laboratory and its level of automation determines to what extent the respective methods are used. Today, the largest laboratories mainly utilize automated solutions (SBT and SSO) as their primary technology, while smaller laboratories generally prefer SSP typing. Subsequently, the choice of typing technology is a key parameter for customer categorization.

In the USA, in particular, there are larger laboratories where SBT typing is used for clinical typing. In total, around 70 of the 200 HLA laboratories use SBT technology clinically, and of these, 25 laboratories (around 36 percent) have so far chosen Allenex as SBT supplier. Of the 70 laboratories that use SBT technology, around 10 - 15 of them type over 1 500 tissue samples each per year, with a few typing even more than that. These are the laboratories that Allenex has initially chosen to target, as they hold high value as reference customers, which is important in this segment. Among these large laboratories, Allenex currently has four customers. In Europe, the trend is that larger laboratories or consortiums of laboratories are becoming more active. This is the case in particular in Germany, where a few really large laboratories are taking a more extensive hold of the typing market.

 

 

2 (11)


LOGO

 

MARKET PERFORMANCE

Traditional SSP typing is still a key technology in the vast majority of HLA laboratories worldwide. Although the technology has been around for 25 years, it still generates steady sales in most markets and in this market Allenex SSP products continue to win an increasingly larger share of the market. The technology is easily adapted to meet today’s needs and thanks to this flexibility Allenex continues to regard it as an important part of the company’s product mix for the foreseeable future. Despite this, there are of course challenges to address, in particular from the more automated technologies such as SSO, SBT and real-time PCR.

Allenex strategy is to introduce SBT Resolver™ to the largest and most automated HLA laboratories in the U.S. and Europe, to then, in a second phase, focus on converting mid-sized laboratories from competing products. A number of the largest laboratories have very high volumes as they conduct tests for national or regional typing registers. Major register typing laboratories conduct HLA typing tests on more than 5 000 individuals per year and are very careful in their evaluation of new suppliers.

In recent years, two new advanced technologies have been tested. These are Next Generation Sequencing (NGS), which primarily targets laboratories that conduct register typing, and real-time PCR (also called qPCR), which is mainly used for typing deceased donors prior to an organ transplant. To date, these two technologies are used on a limited scale, however usage is expected to increase in the coming years. It is believed that NGS will primarily compete with SSO and SBT, while Real-Time PCR is expected to mainly compete with SSP and SSO.

PRODUCT DEVELOPMENT

Allenex SSP products are updated on an ongoing basis and the strategy is to offer as close to total solutions as possible. Product development is also done on a continuous basis, enabling the company to maintain its leading position in the SSP market. Allenex continues to develop the current product line to secure high performance SSP typing. The company is also reviewing solutions tailored to laboratories looking for SSP technology with the option of increased automation that can be used as a complement to SSO and SBT technologies. In 2012, Allenex introduced Olerup SSP® Add-ons, a complement to the automated technologies (SSO and SBT). In 2014, additional Olerup SSP® products were introduced with the aim of meeting customer demands for improved HLA typing with traditional SSP technology.

In 2014, active development began at Allenex on a completely new product group for HLA typing based on real-time PCR (q-PCR) methodology. The starting point for the development work is SSP technology, which is at the core of the Allenex product range today. The new product QTYPE® will primarily focus on low-resolution typing in conjunction with organ

transplantation and typing that either requires ease of administration and expedient results, or where high-resolution typing is not a requirement, such as in family donor screenings prior to stem cell transplants. Allenex new product is based on hydrolysis probes, commonly referred to as TAQMAN® technology, and differs from the existing products on the market. This technology has a number of significant advantages over melt curve technology. Among other benefits, there is greater opportunity to update the products as new alleles are identified. Furthermore, typing with TaqMan® technology is significantly faster.

QTYPE® will initially compete with traditional SSP typing, a sector where Allenex has products today, as well as with existing real-time solutions, but also with SSO. In SSP, the company expects to challenge other suppliers and win market share. Great opportunity to win market share is also seen in the SSO segment where One Lambda is dominant today. When transplanting organs from deceased donors it is of key importance to be able to expediently carry out HLA typing to find an appropriate recipient. Real-time PCR is a more automated method that provides faster results with a lesser proportion of manual work compared to SSP. Typing with QTYPE® will take around one hour compared to the up to three hours it takes to do traditional SSP typing. In this context, SSO typing is relatively slow, taking 5 - 7 hours to conduct. Besides organ transplantation, the method has applications in other types of medical conditions.

QTYPE® was introduced at the end of April 2015 at the European HLA congress, EFI, in Geneva. At the end of September 2015, QTYPE® was also presented to the American market at the corresponding American HLA congress, ASHI, in Savannah, Georgia. It is currently estimated that the new product will start generating sales in the early third quarter 2016.

The distribution agreement between Conexio Genomics and Allenex subsidiary Olerup SSP AB runs through April 2018. In addition to the distribution of SBT Resolver™, the contract with Conexio Genomics includes two new products for Next Generation Sequencing (NGS), reagents and software. Also included is Gamma Type™, a product for typing of the Gamma block, an area that previously was not possible to analyze using traditional methods. The introduction of Gamma Type™ began during the first six months of 2015 and the plan is to successively introduce the NGS portfolio over the next two years.

SIGNIFICANT EVENTS IN ALLENEX

Significant events in the first quarter

 

    On February 9, 2016, CareDx, Inc. announced revised terms of its offer to the shareholders of Allenex AB. The Board of Directors’ recommendation to the shareholders of Allenex to accept the offer remains unchanged.
 

 

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Significant events after the period end

 

    On April 8, 2016, CareDx, Inc. announced that the offer to the shareholders of Allenex AB had been accepted by shareholders representing a total of 118 207 862 shares, equivalent to around 98.3 percent of the number of outstanding shares, and that the offer is unconditional. CareDx intends to initiate compulsory acquisition of the remaining shares in the company and in conjunction with this will push for the share to be delisted from NASDAQ Stockholm.

OPERATING RESULTS

Consolidated operating profit for the first three months amounted to SEK 1.7 million (5.8). The Swedish krona strengthened against USD during the first quarter, while weakening against EUR mid-quarter. These effects offset each other and currency fluctuations during the quarter have not had any substantial impact on net revenues. In the corresponding period in 2015, currency fluctuations had a positive effect on revenues resulting from a weaker Swedish krona.

Unrealized currency gains included in other expenses are substantially lower compared to the first quarter 2015, amounting to SEK 0 million (3.2). Realized currency effects, resulting from the purchase of raw materials and consumables in USD and EUR, are also substantially lower compared to the first quarter 2015, and are included in other expenses at SEK -0.2 million (0.9). Currency effects impacting net financial items is substantially lower compared to the first quarter 2015, amounting to SEK 0 million (2.1). Costs for other external services are included in other expenses and have increased compared to the first quarter 2015, amounting to SEK 2.1 million (1.8), at the same time employee remuneration costs have decreased compared to the first quarter 2015, amounting to SEK 12.1 million (12.6).

FINANCIAL POSITION, CASH FLOW AND FINANCING

New product development expenses of SEK 2.3 million (3.0), were capitalized during the period, leaving a closing balance on March 31, 2016 of SEK 17.9 million (5.8). The capitalization concerns the development QTYPE® a new product for HLA typing based on real-time PCR (qPCR) methodology.

The operations of Allenex are financed by shareholders’ equity and loans. Interest-bearing liabilities amounted to SEK 107.6 million (110.9). The consolidated equity/assets ratio was 57 percent (58). Consolidated equity was SEK 210.2 million (201.1), corresponding to SEK 1.75 per share (1.67). Equity increased by SEK 0.7 million in the first quarter 2016. Equity decreased by SEK 20 million in the corresponding period in 2015, mainly due to the acquisition of the minority holdings in the group. Cash and cash equivalents amounted to SEK 3.1 million (6.1).

Cash flow from operating activities for the first quarter was SEK 3.1 (3.4). Investing activities includes investments in capitalized assets of SEK 2.3 million. Financing activities included loan amortization of SEK 5.5 million and SEK 4 million in loans raised.

RISKS AND UNCERTAINTIES

Allenex has long been a well-established business with well-known products in the field of genomic HLA typing based on SSP technology, with a significant market share. At the same time, the company faces market risk in the form of competition from other manufacturers, the transition to more automated typing processes as well as new technologies, which may make it difficult for the company to maintain market share and margins.

Operational risk is primarily tied to the company’s ability to constantly update its product range and to produce continually updated HLA test kits in pace with market demand.

Products sold and distributed on the basis of cooperation agreements with other companies increase the opportunity of strengthening market position and profitability, while they also carry increased risk due to commitments in terms of resource investments and costs resulting from such agreements. In particular, the SBT products from the Australian company Conexio Genomics are expected to achieve significant sales. At the same time, this involves significant competition and market risk. The ability to deliver the right quality on time has both a short- and long-term significance for the business. For example, the inability of the partner to deliver due to production downtime could have a substantial negative effect on sales. Under the terms of the agreement with Conexio, Allenex has committed to a minimum purchase level.

In 2014 and 2015 significant development work was conducted on the new product QTYPE® based on real-time PCR methodology. It is expected that the product will successively generate significant sales. There is a risk that this will take longer than previously planned and that the product will not achieve the success expected. This in turn may have a negative impact on the value of intangible and other assets.

The transplantation test XM-ONE® is predominantly established as a research product for larger medical centers. Work is underway to get the product established in broader clinical use. This has proven to take longer than planned and there is a risk that the product may not attain the success anticipated. This in turn could have a negative on the value of the company’s intangible and other assets. To date, XM-ONE® is virtually alone in its field and has significant patent protection. However, work is ongoing at the company’s competitors to establish similar testing methods. There is a risk, therefore, that the company’s competitors may challenge the position that XM-ONE® has on the market.

 

 

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Allenex has a significant exposure to exchange rate fluctuations due to the fact that most of the company’s revenues are in EUR and USD, while costs are partly in SEK. This entails a currency risk for the company. Allenex does not conduct currency hedging activities.

Attracting and maintaining qualified personnel for development, production, marketing, sales, logistics and administration is essential to group performance.

The value of the company is partly dependent on its ability to maintain and protect patents, other intellectual property rights and specific expertise. Patent protection for medical, medtech and biotech products can be uncertain and involve complex legal and technical issues. Patents must usually be sought and maintained in several jurisdictions, and issued patents may be challenged, invalidated and circumvented. For Allenex, or its subsidiaries, this may mean the loss of or shortened patent protection, which in turn may mean that the company cannot prevent competitors from marketing similar products. The uncertainty associated with patents and patent litigation and other patent processes, may have a negative impact on the competitiveness of Allenex and its subsidiaries, which in turn may have a negative effect on their business.

Both clinical trials and the marketing and sales of products pose a significant risk in terms of product liability. When deemed necessary, the company obtains product liability insurance. No assurance can be given that insurance will cover future claims against Allenex or its subsidiaries.

In certain cases, the company is dependent on approval through clinical trials or decisions from public authorities. There are no guarantees that the company will achieve satisfactory results in such trials, or that the required regulatory approval will be granted

The group’s customer relations are stable and long-term, with historically low credit losses. Credit evaluations are carried out on new customers. Credit risk is currently assessed as low, but any change in a negative direction could impact the company’s results and financial position.

Part of the financing was raised at variable interest rates, therefore rising interest rates could lead to lower returns for the company, which in turn could affect the company’s results and financial position.

Based on the current circumstances, Allenex is of the opinion that it has sufficient liquidity to conduct its operations according to current plans. There is a risk that market conditions and sales will develop negatively, which may have a negative effect on liquidity. The group’s ability to refinance maturing loans may also be adversely impacted by group performance and overall conditions in the financial markets.

The company’s cash and cash equivalents are placed in liquid assets with low credit risk.

No significant changes in risk assessment have been made compared to the annual report 2015, pages 27-28.

FINANCIAL INSTRUMENTS

Allenex financial instruments consist of trade account receivable, cash and cash equivalents, trade accounts payable, accrued supplier expenses and interest-bearing liabilities. Liabilities to credit institutions have variable interest rates. Liabilities to shareholders and SSP Primers AB have fixed interest rates, which essentially correspond to current market rates. Other financial assets and liabilities have short life spans. The fair value of all financial instruments is deemed to approximate the book value. Allenex has not netted any financial assets or liabilities and has not entered into any offset agreements.

TRANSACTIONS WITH RELATED PARTIES

Transactions with related parties are shown in Note 10 of the Allenex 2015 Annual Report. No substantial changes occurred in the content or scope of these transactions for the period.

PARENT COMPANY

Revenues for the period amounted to SEK 0.7 million (0.7). Operating loss for the quarter was SEK 3.0 million (-3.2). The company’s long-term intragroup receivables amounted to SEK 161.7 million (88.1). Cash and cash equivalents totaled SEK 0.8 million (1.1). Cash flow from operations was SEK 0.1 million (-3.2). At the period end, the parent company had 4 employees (4).

SHARE AND SHAREHOLDERS

 

PRINCIPAL OWNERS, MARCH 31, 2016

   NO. SHARES      OWNERSHIP
STAKE %
 

Midroc Invest AB

     43 678 850         36.3   

Ålandsbanken ABP (Finland)

     38 945 781         32.4   

Xenella Holding AB *)

     11 174 755         9.3   

Handelsbanken Liv

     6 816 152         5.7   

Avanza Bank AB

     4 838 585         4.0   

Nordnet Pensionsförsäkring AB

     2 427 292         2.0   

Other

     12 407 033         10.3   
  

 

 

    

 

 

 

TOTAL

     120 288 448         100.0   
  

 

 

    

 

 

 

 

*) Xenella Holding AB is jointly owned by Midroc Invest AB and FastPartner AB (publ).

ACCOUNTING PRINCIPLES

Allenex applies International Financial Reporting Standards (IFRS) as adopted by the EU and the Swedish Annual Accounts Act. This interim report was prepared in accordance with IAS 34 and the Annual Accounts Act for the group and for the parent company. The accounting principles and methods of calculation applied for the group and the parent company are consistent with those used in the preparation of the most recent Annual Report, with the exception of the impairment of intangible assets, which previously were written down in pace with sales. These are now amortized on a straight line basis over the remaining useful life.

 

 

 

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  ANNUAL GENERAL MEETING
  The Allenex General Meeting will take place on Thursday, May 19, 2016 at Allenex, Franzéngatan 5, Stockholm.
  Stockholm, May 6, 2016
Anders Karlsson  
Chief Executive Officer  
  The information in this interim report is such that Allenex AB (publ) is required to disclose under the Securities Market Act and/or the Financial Instruments Trading Act. This report and earlier financial reports are available on www.allenex.com
  This yearend report has not been subject to review by the auditors of Allenex.
 
 

 

This information was released for publication on May 6, 2016 at 12.30 CET

 

 

 

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Consolidated statement of comprehensive income summary

 

     2016      2015      2015  

In SEK thousand

   JAN-MARCH      JAN-MARCH      JAN-DEC  

Net sales

     32 612         33 701         134 548   

Change in inventories

     -1 084         -1 390         4 092   

Capitalized work for own account

     700         490         2 354   

Other revenues

     656         1 095         3 481   
  

 

 

    

 

 

    

 

 

 
     32 885         33 896         144 475   

Raw materials and consumables

     -7 703         -7 759         -29 272   

Other expenses

     -10 342         -6 728         -38 323   

Cost of employee remuneration

     -12 050         -12 582         -48 582   

Depreciation/Amortization

     -1 109         -1 006         -4 130   
  

 

 

    

 

 

    

 

 

 

Operating results

     1 681         5 821         24 168   

Other financial expenses and income

     -1670         830         -5 421   
  

 

 

    

 

 

    

 

 

 

Results after financial items

     11         6 651         18 927   

Taxes

     407         -1 105         -3 795   
  

 

 

    

 

 

    

 

 

 

Net income for the period

     417         5 546         15 132   
Other comprehensive results for the period                     

Components that will not be reclassified to net results

     —           —           —     

Components that will be reclassified to net results

     —           —           —     

Translation differences for the period

     300         -6 003         -7 139   
  

 

 

    

 

 

    

 

 

 

Comprehensive results for the period

     717         -457         7 993   

Results for the period attributable to:

        
  

 

 

    

 

 

    

 

 

 

Owners of the parent company

     417         5 546         15 132   

Non-controlling interests

     0         0         —     
  

 

 

    

 

 

    

 

 

 

Comprehensive results for the period attributable to:

        

Owners of the parent company

     717         -457         7 993   

Non-controlling interests

     0         0         —     
  

 

 

    

 

 

    

 

 

 

Earnings per share, basic and diluted, SEK

     0.00         0.05         0.13   

Average number of outstanding shares, basic and diluted

     120 288 448         120 288 448         120 288 448   

Number of shares at the period end

     120 288 448         120 288 448         120 288 448   

 

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Consolidated statement of financial position

 

     2016      2015      2015  

In SEK thousand

   MARCH 31      MARCH 31      DEC 31  

Assets

        

Goodwill

     215 041         215 086         214 962   

Other intangible assets

     75 896         66 896         74 340   

Tangible assets

     3 656         3 141         3 481   

Deferred tax assets

     3 796         2 992         2 935   
  

 

 

    

 

 

    

 

 

 

Total non-current assets

     298 389         288 115         295 718   

Inventories

     44 376         35 810         41 269   

Current receivables

     20 038         17 909         18 593   

Cash and cash equivalents

     3 108         6 097         4 294   
  

 

 

    

 

 

    

 

 

 

Total current assets

     67 521         59 816         64 156   

Total assets

     365 910         347 931         359 874   

Equity and liabilities

        

Equity

     210 220         201 053         209 503   

Interest-bearing non-current liabilities

     97 500         95 937         87 870   

Deferred tax liabilities

     16 733         14 123         16 394   

Interest-bearing current liabilities

     10 173         14 961         21 113   

Non-interest bearing current liabilities

     31 283         21 857         24 994   
  

 

 

    

 

 

    

 

 

 

Total equity and liabilities

     365 910         347 931         359 874   
Consolidated statement of changes in equity         
     2016      2015      2015  

In SEK thousand

   MARCH 31      MARCH 31      DEC 31  

Opening balance

     209 503         220 480         220 480   

Dividends paid to non-controlling interests

     —           —           —     

Acquisition of minority holdings in subsidiaries

     —           -18 970         -18 970   

Comprehensive results for the period

     717         -457         7 993   
  

 

 

    

 

 

    

 

 

 

Closing balance

     210 220         201 053         209 503   

Of which attributable to:

        
  

 

 

    

 

 

    

 

 

 

Owners of the parent company

     210 220         201 053         209 503   

Non-controlling interests

     0         0         —     
  

 

 

    

 

 

    

 

 

 
Consolidated statement of cash flows         
     2016      2015      2015  

In SEK thousand

   JAN-MARCH      JAN-MARCH      JAN-DEC  

Operating income

     1681         5 821         24 168   

Adjustment for items not included in the cash flow

     1 134         -1 712         -503   

Financial items

     -686         -650         -3 181   

Taxes paid

     -168         -371         -1 565   
  

 

 

    

 

 

    

 

 

 

Cash flow from operations before changes in working capital

     1 960         3 088         18 919   

Increase (-)/Decrease(+) in inventories

     -3 189         1 390         -3 053   

Increase (-)/Decrease(+) in operating receivables

     -1 410         -669         -641   

Increase (-)/Decrease(+) in operating liabilities

     5 803         -400         -528   
  

 

 

    

 

 

    

 

 

 

Cash flow from operating activities

     3 164         3 409         14 697   

Cash flow from investing activities 1)

     -2 799         -9 077         -14 045   

Cash flow from financing activities 1)

     -1 533         4 500         -3 715   
  

 

 

    

 

 

    

 

 

 

Cash flow for the period

     -1 168         -1 168         -3 063   

Cash and cash equivalents at the start of the period

     4 294         7 323         7 323   

Exchange rate differences in cash and cash equivalents

     -18         -58         -34   
  

 

 

    

 

 

    

 

 

 

Cash and cash equivalents at the period end

     3 108         6 097         4 294   

 

1)  In 2016, investing activities includes investments in capitalized assets of SEK 2.3 million as well as the acquisition of tangible fixed assets of SEK 0.5 million. In 2016, financing activities includes a newly raised shareholder loan of SEK 4 million and SEK 5.5 million in amortization payments. In 2015, investing activities included the acquisition of minority holdings for SEK 20 million less a debt to SSP Primers of SEK 14 million, net SEK 6 million, and investments in capitalized assets of SEK 3.0million. In 2015, financing activities included a new bank loan of SEK 10 million, amortization of SEK 1.5 million as well as the repayment of a loan of SEK 4 million to SSP Primers.

 

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Parent company income statement

 

     2016      2015      2015  

In SEK thousand

   JAN-MARCH      JAN-MARCH      JAN-DEC  

Revenues

     687         687         2 749   

Other external costs

     -1 943         -1 893         -8 186   

Personnel costs

     -1 728         -1 992         -8 281   

Depreciation/amortization

     -29         -27         -112   
  

 

 

    

 

 

    

 

 

 

Operating results

     -3 013         -3 225         -13 830   

Other financial expenses and income

     -591         -463         -2 135   
  

 

 

    

 

 

    

 

 

 

Results after financial items

     -3 604         -3 688         -15 965   

Appropriations

        

Group contributions received

     —           —           22 959   

Group contributions paid

     —           —           -2 762   
  

 

 

    

 

 

    

 

 

 

Results before tax

     -3 604         -3 688         4 232   

Taxes

     0         0         0   
  

 

 

    

 

 

    

 

 

 

Results for the year

     -3 604         -3 688         4 232   

Parent company statement of comprehensive income

        

Results for the period

     -3 604         -3 688         4 232   

Other comprehensive results for the period

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Comprehensive results for the period

     -3 604         -3 688         4 232   

Parent company balance sheet

 

     2016      2015  

In SEK thousand

   MARCH 31      DEC 31  

Assets

     

Tangible assets

     84         84   

Participations in group companies

     77 378         77 378   

Non-current intra-group receivables

     161 650         159 656   

Deferred tax assets

     1 626         1 626   
  

 

 

    

 

 

 

Total non-current assets

     240 738         238 744   

Current receivables

     12 853         11 502   

Cash and bank

     808         2 144   
  

 

 

    

 

 

 

Total current assets

     13 661         13 646   

Total assets

     254 399         252 390   

Equity and liabilities

     

Equity

     165 770         169 375   

Non-current liabilities

     31 000         31 870   

Current liabilities

     57 630         51 145   
  

 

 

    

 

 

 

Total equity and liabilities

     254 399         252 390   

Changes in equity, parent company

     
  

 

 

    

 

 

 

Opening balance

     169 375         165 143   

Results for the period

     -3 604         4 232   
  

 

 

    

 

 

 

Closing balance

     165 771         169 375   

 

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Key figures, Group

 

     2016      2015  
     JAN-MARCH      JAN-MARCH  

Net sales, SEK thousand

     32 612         33 701   

Operating income, SEK thousand

     1 681         5 821   

Earnings after tax, SEK thousand

     417         5 546   

Earnings per share, basic and diluted, SEK

     0.0         0.0   

Equity per share, SEK

     1.75         1.67   

Equity/assets ratio, %

     57         58   

Return on equity, %

     0         0   

Average number of employees

     57         55   

Number of shares outstanding at the period end

     120 288 448         120 288 448   

Average number of shares outstanding

     120 288 448         120 288 448   

Share price at the period-end, SEK

     2.5         2.1   

Market cap, SEK thousand

     300 721         252 606   

Definitions:

 

Earnings per share    Earnings after tax attributable to the owners of the parent company divided by the average number of outstanding shares.
Equity per share    Equity divided by the number of outstanding shares at the period end.
Equity/assets ratio    Equity at the period-end in relation to total assets.
Return on equity    Results attributable to parent company shareholders divided by equity attributable to the owners of the parent.
Operating margin    Earnings before financial items divided by net sales

For a more detailed glossary see annual report 2015 page 66

 

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Allenex and subsidiaries

 

PRODUCTION AND R&D COMPANIES

 

 

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SALES & DISTRIBUTION COMPANIES

 

 

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Olerup SSP AB is world leading in the development of kits for genomic HLA typing, based on SSP technology. The product is used prior to a transplantation to match the donor and recipient. The better the match the lower the risk of complications following transplantation. HLA typing is a standard procedure prior to hematopoietic stem cell transplantation (bone marrow transplantation) and is also used in conjunction with organ transplants (kidney, lung, heart, etc.). In 2011, Olerup SSP entered into an exclusive global agreement (excl. Australia, New Zealand and Taiwan) with Conexio Genomics, Perth, Australia. The agreement runs through April 2018, at least. Allenex ownership stake in Olerup SSP AB is 100 percent. For more information visit www.olerup-ssp.com

Olerup GmbH, based in Vienna, is responsible for sales, distribution and logistics in Europe and the rest of the world excluding North, Central and South America as well as the Nordic region. Sales encompass Olerup SSP’s HLA typing products and AbSorber’s XM-ONE® transplantation test. Furthermore, from mid-year 2011, the company also sells and distributes products from the Australian company Conexio Genomics. Sales are conducted by a proprietary sales team in Germany, Austria, Belgium, the Netherlands and Slovenia. Sales in other markets are handled by distributors. The company is owned by Olerup International AB, a wholly-owned company of Allenex AB. For more information visit www.olerup.com

 

 

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AbSorber develops products that facilitate successful transplantation. AbSorber’s transplantation test XM-ONE®, identifies antibodies that play a key role in rejection reactions. The company’s research portfolio also includes a patented AB0 column for transplantations between people of different blood groups and an AB0 diagnostic test that measures the occurrence of blood group antibodies. Allenex ownership stake of AbSorber is 100 percent. For more information visit www.absorber.se

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Olerup Inc., domiciled in West Chester, PA, USA, is responsible for the sales, distribution and logistics of Olerup SSP and AbSorber products. Furthermore, since mid-2011, the company sells and distributes products from the Australian company Conexio Genomics. The company has its own sales organization in the US, while sales in Canada and Central and South America are handled by distributors. Olerup Inc., is a wholly-owned company of AbSorber AB. For more information visit www.olerup.com

 

 

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