0001193125-15-404240.txt : 20151216 0001193125-15-404240.hdr.sgml : 20151216 20151216073500 ACCESSION NUMBER: 0001193125-15-404240 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20151216 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20151216 DATE AS OF CHANGE: 20151216 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: 151289882 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 d73537d8k.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): December 16, 2015

 

 

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 7.01. Regulation FD Disclosure

On December 16, 2015, CareDx, Inc. (the “Company”) issued a press release announcing a tender offer to acquire the shares of Allenex AB. In the press release, the Company also announced that it would be holding a conference call on December 16, 2015 to discuss the tender offer. The full text of the press release is attached hereto as Exhibit 99.1 and the script for the conference call is attached hereto as Exhibit 99.2, and are incorporated herein by reference.

On December 16, 2015, the Company also issued a press release in Sweden announcing the recommended public offer to acquire the shares of Allenex AB. The full text of the press release is attached hereto as Exhibit 99.3 and is incorporated herein by reference.

 

ITEM 9.01 Financial Statements and Exhibits

(d) Exhibits

 

Exhibit No.

  

Description

99.1    Press release issued by CareDx, Inc. dated December 16, 2015
99.2    Script for conference call on December 16, 2015
99.3    Press release issued by CareDx, Inc. dated December 16, 2015


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: December 16, 2015    
   

By: /s/ Ken Ludlum

    Ken Ludlum
    Chief Financial Officer


EXHIBIT INDEX

 

Exhibit No.

  

Description

99.1    Press release issued by CareDx, Inc. dated December 16, 2015
99.2    Script for conference call on December 16, 2015
99.3    Press release issued by CareDx, Inc. dated December 16, 2015
EX-99.1 2 d73537dex991.htm EXHIBIT 99.1 Exhibit 99.1

Exhibit 99.1

 

LOGO

CareDx Announces Agreement to Purchase 78 Percent of the Outstanding Shares of Allenex AB

and Plans to Launch Tender for Remaining Shares in First Quarter 2016

Combination Creates an International Transplantation Diagnostics Company with Expanded

Distribution and Growth Potential

BRISBANE, CA, December 16, 2015: CareDx, Inc. (Nasdaq: CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant patients, today announced an agreement to acquire approximately 78% of the outstanding shares of Allenex AB (Stockholm: ALNX, S+) from its three principal shareholders, and plans to launch a tender offer for the remaining 22% of the shares of Allenex in the first quarter of 2016. The Allenex Board of Directors has unanimously recommended that Allenex shareholders accept the tender offer. Completion of the tender offer is expected by the end of March 2016. The total purchase price of Allenex will be approximately $35 million consisting of a combination of cash and stock in CareDx.

Allenex is a transplant diagnostics company based in Stockholm, Sweden that develops, manufactures, markets and sells products that match donor organs with potential recipients prior to transplantation.

The combination of CareDx and Allenex will create an international transplantation diagnostics company with product offerings along the pre-/post-transplant continuum. The Olerup SSP line, which addresses Human Leukocyte Antigen, or HLA, testing, and AlloMap are foundational diagnostics which are well recognized by the transplant community. The combined company will have a presence and direct distribution channels in the US and Europe.

The terms of the tender offer include an all cash alternative or a mixed consideration alternative consisting of cash and stock. If the offer is accepted in its entirety under the mixed consideration alternative, 1,560,807 shares of common stock will be issued by CareDx in the transaction, which will represent approximately 11.6% of the outstanding shares of CareDx after completion of the acquisition. The three principal shareholders of Allenex have agreed to the mixed consideration alternative, and a portion of their cash payments will be subject to certain commercial and financial milestones in the fourth quarter of 2015 and over the course of 2016.

CareDx has secured a loan commitment from Oberland Capital SA Davos LLC (“Oberland Capital”) pursuant to which Oberland Capital will lend up to $50 million. $16 million of the loan will be used to pay down CareDx’s existing loan with East West Bank. An additional $16.5 million will be used to fund a portion of the acquisition. CareDx will finance the remainder of the acquisition through its existing cash resources. Drawdowns under the loan commitment are subject to certain conditions being satisfied or waived by Oberland Capital.


The leadership of both organizations offered the following comments:

“Allenex is an ideal strategic fit for CareDx. Both organizations have well-established products, strong relationships with transplant centers in key regions and a long tenure in transplant care,” said Peter Maag, PhD Chief Executive Officer and President of CareDx. “Through this acquisition, we are executing on our growth strategy. The combined company will offer the opportunity for new product development and growth in a complex and costly area of healthcare. We are excited by the prospect of leveraging our shared cultures of patient centricity and continued innovation. The combined company will have outstanding talent with deep expertise in transplantation”, Mr. Maag concluded.

“Allenex is a leader in HLA testing led by our flagship Olerup test to match transplant recipients with donor organs. I am thrilled by the opportunity to combine Allenex with CareDx”, said Anders Karlsson, CEO of Allenex. “The focus of CareDx on improving the lives of transplant recipients through non-invasive surveillance testing like AlloMap compliments well with our products. Our combination will offer patients and clinicians a broader range of transplant diagnostic offerings, which should strengthen the ability to provide long term and truly personalized patient care.”

Further details of the offer can be found here: http://news.cision.com/caredx--inc-/r/caredx-announces-a-recommended-public-offer-to-all-shareholders-in-allenex,c9885632

Conference Call

CareDx will host a conference call to discuss the Offer on 16 December 2015 at 5:00 a.m. Pacific Standard Time (14:00 Central European Time). Interested parties may join the conference call by dialing +1 855-420-0616 (within the U.S.) or +1 678-304-6848 (outside of the U.S.). The participant passcode is 6934784. The Audio Webcast will also be available on the investor relations section of the CareDx website at: www.caredx.com.

A replay of the call will be available beginning 16 December 2015 at 7:00 a.m. Pacific Standard Time (16:00 Central European Time). To access the replay, dial +1 855-859-2056 or +1 404-537-3406 and reference Conference ID: 6934784.

About Allenex AB

Allenex AB, headquartered in Stockholm, is a life sciences company that develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between the donor and the recipient of stem cells and organs. Allenex AB currently markets two key products; Olerup SSP, a set of HLA typing used prior to hematopoietic stem cell/bone marrow transplantation and organ transplantation, and XM-ONE®, the first standardized test that quickly identifies the patient’s antigens against HLA Class I, Class II or antibodies against the donor’s endothelium.

About CareDx

CareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, diagnostic surveillance solutions for transplant patients. The Company has commercialized AlloMap®, a gene expression test that aids clinicians in identifying heart transplant recipients with stable graft function who have a low probability of moderate/severe acute cellular rejection. CareDx is also pursuing the development of additional products for post-transplant monitoring. For more information, please visit: www.CareDx.com.


About Oberland Capital

Oberland Capital is an investment firm focused on the healthcare industry specializing in flexible, non-dilutive investment structures customized to meet the specific capital requirements and strategic objectives of transaction partners globally. The firm offers a broad suite of financing solutions including the monetization of royalty streams, acquisition of future product revenues, creation of project-based financing structures, and investment in debt and equity securities. For more information, please visit www.oberlandcapital.com.

Forward Looking Statements

This press release contains forward-looking statements including, but not limited to statements regarding the Company’s expectations regarding future potential, development and commercial activities. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward looking statements, including CareDx’s limited operating history and experience with developing new markets; that closing conditions may not be satisfied and the transaction may not be completed; that the business acquired in the acquisition will not be integrated successfully; that the benefits of complementary product portfolios may not be realized; that products launched by the combined company will not be successfully commercialized or commercialization efforts may be slower than anticipated; that the combined company is not able to maintain current revenue levels; risk relating to new partnerships and commercialization of those relationships, as well as other risks stated in CareDx’s filings with the SEC located at www.sec.gov. CareDx disclaims any obligation to publicly update or revise any forward looking statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

Media Contact    Investor Contact
Molly Martell, CareDx, Inc.    Leigh J. Salvo, Westwicke Partners, LLC
T: +1 415-287-2397    T: +1 415-513-1281
E: mmartell@caredx.com    E: leigh.salvo@westwicke.com
EX-99.2 3 d73537dex992.htm EXHIBIT 99.2 Exhibit 99.2

Exhibit 99.2

CareDx Allenex Conference Call

Wednesday, December 16, 2015

5:00 a.m. PT/2:00 p.m. CET

 

Operator

Good morning, and welcome to CareDx’s conference call to announce the agreement to acquire Allenex. My name is             and I’ll be your coordinator operator for the call today. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today’s call. As a reminder, this conference is being recorded today, December 16, 2015. I would now like to turn the conference over to Leigh Salvo, Investor Relations. Please go ahead.

 

Leigh Salvo

Thank you for participating in today’s call. Joining me from CareDx are Peter Maag, President and Chief Executive Officer and Ken Ludlum, Chief Financial Officer.

Earlier today CareDx announced a Public Offer to acquire Allenex. The release is currently available on the company’s website at www.caredx.com.

Before we begin, I’d like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements. All forward-looking statements, including, without limitation, our examination of

 

Page 1


historical operating trends and our future financial expectations, are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please see our filings with the SEC.

CareDx disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of today’s live broadcast.

I will now turn the call over to Peter Maag. Peter?

 

Peter Maag

Thanks, Leigh.

Good morning to those of you in the U.S. and good afternoon to those of you in Europe. Thank you all for joining us. We are excited to share the news that we have made an offer to acquire Allenex, a global diagnostics company that develops, manufactures, markets and sells high quality products that facilitate stem cell and solid organ transplantation. This combination allows us to accelerate on our strategy to provide transplant patients access to better care along the pre-/-post transplant continuum.

 

Page 2


This announcement really delivers on our strategic growth objectives laid out in the beginning of the year: Grow AlloMap, Develop AlloSure and add inorganic growth.

While both companies have been working successfully independently, largely in different geographies, in many ways, we have also been working in parallel—both dedicated to providing physicians and transplant patients better solutions. As you will hear today, this exciting transformational transaction maximizes the strengths and leadership positions of both companies. We share the same core values on patient centricity and leading with innovation.

On our call today, I’ll first lay out who Allenex is and what they do in order to provide context on this compelling combination. Then, I will outline the strategic merits of this transaction and frame how Allenex fits in our portfolio and our broader vision. Our CFO, Ken Ludlum, will describe the offering to Allenex shareholders and provide some high level commentary on the potential implications to our financials and finally, we will open it up for your questions.

Allenex, headquartered in Stockholm, is a diagnostics company that develops, manufactures, markets and sells high quality products that increase the chance of carrying out successful transplants by facilitating a better match between the donor and the recipient of blood stem cells and organs. The company was founded in 1992 by transplantation physician Olle Olerup. Their current CEO Anders Karlson is an experienced leader in the healthcare industry – we actually know each other from our previous lives at Novartis.

 

Page 3


Allenex is a leader in Human Leukocyte Antigen or HLA testing, which detects a genetic marker used to confirm tissue and stem cell compatibility between donors and recipients. The brand is extremely strong in HLA laboratories around the world. The global HLA transplant diagnostics market is currently estimated to be $500 million per year.

Allenex currently has a core product offering in the area; Olerup SSP, a set of HLA typing products used prior to hematopoietic stem cell/bone marrow transplantation and organ transplantation. Allenex also markets XM-ONE®, the first standardized test that quickly identifies the patient’s antigens against HLA Class I, Class II or antibodies against the donor’s endothelium.

Allenex has announced that it will launch QTYPE, an HLA typing solution based on real-time PCR technology (RT-PCR). The solution allows for an automated HLA typing process that is quicker than SSP, allows for faster handling and potentially increased chances of successful transplantation. The value proposition is fast turnaround time and cost effectiveness on a limited number of samples – which is especially important in the solid organ transplantation setting and for small to midsized labs.

Allenex sells its products to Transplant laboratories with a strong focus on Europe and has recently made great efforts to expanding its presence in the US and in international Markets, including emerging growth markets like India and Brazil. It draws on a successful mix of direct and distributor based presence in these markets. The relationships with these labs is deep and has been built over decades.

Allenex has roughly 55 employees with sales conducted through direct sales in Vienna, Austria and West Chester, PA as well as through distributors in close to forty countries. Allenex is a public company traded on the OMX exchange in Stockholm, traded under the ticker symbol ALNX.ST.

 

Page 4


Bottom line - Allenex is an ideal strategic fit; complementing CareDx’s strength in transplant patient focus diagnostics and the development of new assays.

So how did this transaction come about? As we have communicated for some time now, one of our strategic goals has been to add momentum through realizing inorganic growth opportunities. Allenex is a natural partner, given their presence and strong reputation in transplantation.

In our many discussions with Allenex, it became clear that we had a lot in common.

 

    Both organizations have strong relationships with leading transplant centers. With a complementary call points. Where CareDx calls on the clinician and the patient – Allenex is focused on the laboratories associated with the same transplant centers.

 

    Both organizations have a deep understanding of Genomic information in transplant patients. Allenex approaches the pre-transplant HLA matching while we focus on the post-transplant surveillance through gene-expression and next generation sequencing applications.

 

    What will glue the companies together is the increasing need for bioinformatic solutions in transplant centers. Providing insights on longitudinal data of the individual patient that spans the pre-post transplant continuum is the future since it is needed to improve long-term outcome in these patients.

 

Page 5


While each company has a track record of successful execution on its own, the product and international diversification brings both entities scale and new opportunities to drive growth and create value than either could achieve on its own. Our combined annual revenue is expected to approach $50M in 2016, giving us greater scale and operating leverage. Moreover, the combination drives numerous benefits, and together, we expect to accomplish several key initiatives:

Let me focus on three key value drivers:

First, our complementary product portfolio and product development pipeline will enable us to expand our addressable markets. The pre-transplant market, which Allenex’s solutions address, is estimated to be approximately $500M and the post-transplant market, which CareDx addresses, is estimated to be greater than $1B. So combined, we have a bigger than $1.5B market opportunity.

As a combined entity, we have core products with the Ollerup SSP line and AlloMap that build the foundation of our transplant presence. The clinical value and brands of these products are well established.

With QType and AlloSure we have 2 launch products based on exciting new technologies (PCR and clinical grade Next Generation Sequencing). While the Allenex team has done a laudable job with launch preparation, with our existing PCR expertise at CareDx, we believe we can add substantial value to the launch of QType on the instrumentation and software side.

Second value driver – is something that we are really excited about: how we will be able to connect these products and their output data together through bioinformatics. Allenex has built a relationship with Conexio, a leading provider of Bioinformatics in transplantation. We hope to foster and elevate this relationship to a completely

 

Page 6


different level. CareDx’s long standing relationship in Next Generation Sequencing with Illumina could be helpful as well. I am confident that the combined entity will be a much more sought after partner in the field of transplantation, further driving the Transplant Eco-system that John Sninsky, our Chief Scientific Officer has outlined in previous communications.

The third value driver is obvious: The combined entity expands the commercial infrastructure with established direct and distributor networks and geographic diversification to support cross selling opportunities for our core and future launch products throughout North America and Europe, including an extensive distributor channel distribution network in Asia, Latin America and the Middle East.

As have become more familiar with the team at Allenex we also feel that there is a tremendous cultural fit between the organization, centered around the dedication to patient management solutions and cohesion that you find in smaller, dedicated companies. Even combined, the 150 or so staff, will maintain this entrepreneurial spirit and patient focus.

Furthermore with our combined capabilities in clinical and regulatory, we expect to rapidly advance these opportunities and continue to innovate. We are adding to our Lab Service model an expertise of supplying ready-made kits in an environment that will be most likely exempt from the upcoming LDT/CLIA/FDA regulations. We see this as an opportunity to provide a unique value proposition to patients, clinicians and transplant labs.

 

Page 7


Finally, the combined company will have an improved financial profile from day one with anticipated pro forma revenues approaching $50 million in 2016. Since Allenex has been a profitable enterprise, we anticipate an acceleration of our operating profitability. Our operating cash flow development will depend on the launch success of QType and AlloSure – with QType offering a faster road to profitability then AlloSure as we are still investing into significant clinical trials.

All of this translates into a company with enhanced flexibility to support future growth opportunities.

Personally, I have lived through a few integration experiences and have learned a lot from them. What is nice here, that we really have complementary companies so the need for realizing synergies and having new headcount targets is not needed. The opposite might be the case – we might develop a series of partnerships that allow us to leverage the combined capabilities in a new way.

You will see from the deal structure that we are adding 3 significant shareholders to the CareDx shareholder list and potentially add an international shareholder component to our mix. We welcome the strengthening of our shareholder base very much and are excited to see the company grow from that perspective as well.

In summary, we are in excited and confident that the combination of our two companies will enhance our leadership position in the field of transplantation, enabling us to now address an international market along the entire pre- /- post-transplant continuum. We share a focused innovation platform to exploit market opportunities, accelerate product development and improve pre- and post-transplant patient outcomes.

 

Page 8


I will now turn the call over to Ken to provide a summary of the offering and some general financial implications to CareDx.

 

Ken Ludlum

Thank you, Peter.

The terms of the offer include an agreement with the three major shareholders of ALLENEX that collectively own about 78% of the shares of ALLENEX. These shareholders have agreed to sell their shares as part of a formal tender offer to all ALLENEX shareholders, which is planned for February in Sweden. In exchange for their shares, these majority shareholders have agreed to sell their shares of Allenex for a combination of cash and stock of CareDx, with a portion of their cash payments to be contingent on the Company reaching certain commercial and financial milestones.

With this purchase agreement now in place, we will proceed to file a formal prospectus with the Swedish Financial Supervisory Authority, in mid-January. After approval, the tender offer can commence and should be completed by the end of February. Final closing should occur in March.

The purchase price of ALLENEX will be made in Swedish Kroner at the equivalent of approximately $35 million U.S. dollars. ALLENEX minority shareholders will have a choice between receiving all cash consideration or a consideration mix of cash and stock of CareDx. If all of the minority shareholders choose to receive the cash consideration alternative, CareDx expects to pay 77% of the total consideration in cash and 23% in shares of CareDx common stock, or $23 million dollars and approximately two million shares of common stock.

 

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Because Allenex minority shareholders will have also a choice to receive all cash consideration, the exact amounts of cash and stock will be determined by the response to the tender offer.

After the closing of this transaction, which we expect to occur towards the end of March, CareDx expects to have about $15 million in the treasury. CareDx will finance this acquisition with a debt facility of up to $50 million provided by Oberland Capital. $16 million of those proceeds will be used to pay down our existing term loan with East West Bank. The remainder will be used to finance the transaction. So the $16.5 million remaining from the new loan together with cash from our balance sheet will be used to pay for the cash portion of the purchase.

ALLENEX had the equivalent of approximately $15 million in product sales in 2014 and $11.8 million in product sales for the first nine months of 2015.

Allenex is a profitable company. Net Earnings were $1 million for 2014 and approximately $1.1 million for the first nine months of 2015 with an operating margin of 15%. This compares to CareDx’s 2014 product sales of almost $26 million and nine months revenues of $21.5 million. If you annualize each company’s nine month results, combined annual revenues would be $45 million.

We expect management at ALLENEX will stay in place and we are looking forward to putting in place plans and strategies to capitalize on cross selling and expanding each company’s presence in their respective European and U. S. markets. Given the complementarity of the business this acquisition will not require cost reductions to achieve efficiencies. It rather builds on each company’s existing presence, as well as people and strengths which will be used to help the other expand into new geographic markets and strengthen the overall presence in transplant centers around the world.

 

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CareDx common shares outstanding will increase from 12 million to approximately 13.3 million, causing a dilution of about 11% to existing holders. In exchange, combined revenues of CareDx increase roughly 50%, and the net loss should decrease. Obviously leverage will increase and interest costs are expected to be approximately $3.5 million a year. ALLENEX does have about $11 million in debt that is staying in place, most of it from Danske Bank, at very favorable terms and interest costs, mostly about 3%.

With that, I’d like to turn the call back to Peter.

 

Peter Maag

We have great respect for the Allenex team and all that they have accomplished. We recognize that achieving all of the benefits of this combination will take careful planning, execution and leadership – and we look forward to working together to achieve that.

I want to close by again expressing how excited I am by this combination which offers an opportunity to deliver longitudinal clinical data and comprehensive patient surveillance solutions. Today’s announcement represents a significant team effort by many individuals within CareDx and Allenex, and I’d like to recognize and thank all involved in getting us this far. We are excited about the opportunity for our expanded team to begin working together to capitalize on the many significant opportunities I’ve described. We look forward to the results of these efforts and the benefit to our physician customers, the patients they serve and to our shareholders.

 

Page 11


With that, we’d now like to open the call up to questions. Operator?

AFTER Q&A:

 

Peter Maag

Thank you, we look forward to updating you on our progress.

 

Page 12

EX-99.3 4 d73537dex993.htm EXHIBIT 99.3 Exhibit 99.3

Exhibit 99.3

The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

PRESS RELEASE, 16 December 2015 (CET)

CareDx Announces a Recommended Public Offer to All Shareholders in Allenex — creating an international pre- and post-transplantation diagnostics company with strong presence and direct distribution in both US and Europe

CareDx, Inc. (NASDAQ: CDNA) – CareDx, Inc. (“CareDx”), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value surveillance solutions for transplant patients, announces a recommended public offer to the shareholders of Allenex AB (“Allenex”) to tender all their shares in Allenex (the “Offer”). Allenex shares are listed on Nasdaq Stockholm (OMX).

The combination of CareDx and Allenex will create an international transplantation diagnostics company with product offerings along the pre-post transplantation continuum. The Ollerup SSP line and AlloMap are foundational diagnostics which are well recognized by the transplant community. The combined company will have presence and direct distribution channels in the US and Europe.

The offer in brief

 

    The shareholders in Allenex, other than Midroc Invest AB, FastPartner AB and Xenella Holding AB, controlling approximately 78 percent of the shares in Allenex, (the “Majority Shareholders”) are offered an all cash alternative (the “All Cash Alternative”) or a mixed consideration alternative (the “Mixed Consideration Alternative”). The Majority Shareholders are offered and have agreed to sell their shares in Allenex in the offer for a mixed consideration alternative which includes a contingent deferred cash component which if paid in full is identical to the consideration offered in the Mixed Consideration Alternative (the “Deferred Consideration Alternative”).

 

    All Cash Alternative: CareDx offers each shareholder in Allenex, other than the Majority Shareholders, a cash consideration of SEK 2.50 per Allenex share. The All Cash Alternative corresponds to a total offer value of approximately SEK 300.7 million.1

 

1  Based on 120,288,448 outstanding Allenex shares.

 

1


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

 

    Mixed Consideration Alternative: CareDx offers each shareholder in Allenex, other than the Majority Shareholders, a cash consideration of SEK 1.731 per Allenex share and 0.01298 CareDx Shares per Allenex share. The Mixed Consideration Alternative values each Allenex share at approximately SEK 2.42 and corresponds to a total offer value of approximately SEK 291.1 million.2

 

    Deferred Consideration Alternative: CareDx offers the Majority Shareholders, and the Majority Shareholders have agreed to sell their shares in Allenex in the offer for (i) 0.01298 CareDx Shares per Allenex share and (ii) an initial cash payment of 1.191 per Allenex Share (the “Initial Cash Payment”) and (iii) up to SEK 0.540 per Allenex share as potential additional cash payments based on the achievement of certain commercial and financial milestones (the “Milestones”) in the fourth quarter 2015 and over the course of 2016 (the “Contingent Cash Payments”)3.

 

    The agreement by the Majority Shareholders to sell their shares in Allenex in the offer is subject only to the Offer being declared unconditional no later than on 8 April 2016.

 

    The price offered for the shares based on the All Cash Alternative represents a premium of approximately 24 percent compared to the closing share price of SEK 2.02 for the Allenex share on Nasdaq Stockholm on 15 December 2015, the last trading day prior to the announcement; and 17 percent compared to the volume-weighted average trading price over the 30 calendar days ending on 15 December 2015 of SEK 2.14.

 

    The price offered for the shares implied by the Mixed Consideration Alternative represents a premium of approximately 20 percent compared to the closing price of SEK 2.02 for the Allenex share on Nasdaq Stockholm on 15 December 2015, the last trading day prior to the announcement; and 13 percent compared to the volume-weighted average trading price over the 30 calendar days ending on 15 December 2015 of SEK 2.14.

 

2  The implied offer value of SEK 2.42 per Allenex share and total offer value of SEK 291.1 million are based on i) a SEK/USD exchange rate of 8.4990 as of 15 December 2015, ii) the closing price for CareDx shares of USD 6.25 as of 15 December 2015 (the last trading day prior to announcement of the Offer), and iii) 120,288,448 outstanding Allenex shares.
3  The total value of the Initial Cash Payment and the Contingent Cash Payments together will not under any circumstances exceed 1.731 per Allenex share but may be lower, should one or more Milestones not be achieved. Thus, the value of the Deferred Consideration Alternative will as a maximum correspond to the value of the Mixed Offer Consideration Alternative.

 

2


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

 

    The Allenex Board of Directors unanimously recommends that Allenex shareholders accept the Offer.4

 

    The Offer is not subject to any financing conditions. CareDx will fund the cash portion of the Offer by utilizing available cash.

 

    The Offer does not require pre-clearance filing with competition authorities.

 

    The initial acceptance period of the Offer is expected to run from 10 February 2016 – 2 March 2016.

Comments from CareDx

Allenex is an ideal strategic fit for CareDx. Both organizations have well established products, strong relationships with transplant centers in key regions and a long tenure in transplant care,” said Peter Maag, PhD, Chief Executive Officer and President of CareDx. “Through this acquisition, we are executing on our growth strategy. The combined company will offer the opportunity for new product development in a complex and costly area of healthcare. We are excited by the prospect of leveraging our shared cultures of patient centricity and continued innovation. The combined company will have outstanding talent with deep expertise in transplantation from both organizations,” Mr. Maag concluded.

Comments from Allenex and the Majority Shareholders

Allenex is a leader in HLA testing led by our flagship Olerup test to match transplant recipients with donor organs. I am thrilled by the opportunity to combine Allenex with CareDx”, said Anders Karlsson, CEO of Allenex. “CareDx’ focus on improving the lives of transplant recipients through surveillance testing like AlloMap complements well with our products. Our combination will offer patients and clinicians a broader range of transplant diagnostic offerings, which should strengthen the ability to provide long-term and truly personalized patient care.

The Board of Directors of Allenex has unanimously decided to recommend the offer from CareDx. It is our assessment that Allenex and CareDx complement each other well, both geographically and in terms of product portfolios. We have also, in our overall assessment, considered the prospects for Allenex to operate as an independent company and the risks associated therewith. We have concluded that the combination of the two companies will allow Allenex to best realize its potential,” said Anders Williamsson, chairman of the Allenex Board.

 

4  Since the Majority Shareholders have agreed to sell their shares in connection with the Offer (please see “Undertaking to accept the Offer” below), Oscar Ahlgren, Director of the Board of Directors of Midroc Invest AB and Xenella Holding AB, and Sven-Olof Johansson, CEO and main shareholder of Fastpartner AB and Director of the Board of Directors of Xenella Holding AB, have, due to conflict of interests, based on the above mentioned commitments, not participated in the preparations and issues related to the Offer in the Allenex Board of Directors. All other members of the Board of Directors of Allenex, all of which are independent of the company, the management and the major shareholders in the company, have participated in the handling of the issue and the Board of Directors has therefore been quorate.

 

3


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

We believe in the long-term strategic rationale and industrial logic of the combination of Allenex and CareDx, creating a stronger global company in transplant diagnostics,” stated Oscar Ahlgren, Director of the Board of Directors of Midroc Invest AB and Xenella Holding AB, and Sven-Olof Johansson, CEO and main shareholder of Fastpartner AB and Director of the Board of Directors of Xenella Holding AB.

Background and reasons

The combination of CareDx and Allenex will create an international transplantation diagnostics company with strong presence and direct distribution in both the US and Europe. It is anticipated that CareDx’ and Allenex’ complementary geographies and product portfolios create a pre-post transplantation continuum, giving the combined company a strategic advantage to address the breadth of the international transplantation diagnostics market.

 

    The combination will create commercial channel synergies with opportunities to cross-sell CareDx’ and Allenex’ products since the product portfolios often address the same organ transplant patient and the same hospital transplant centers.

 

    Furthermore, the combined company will share a strong technology and innovation platform within both traditional sequencing and Next-Generation Sequencing (“NGS”), which would allow for the development of new outcome-oriented personalized patient management solutions.

 

    The goal is to create an international transplant diagnostics company with the vision to transform long-term patient care by offering personalized management solutions building on insights from clinical diagnostics.

Management and employees

CareDx recognizes the skills and capabilities of the management and employees of Allenex and does not intend to make any material changes to Allenex’ employees or to Allenex’ existing organization and operations, including the terms of employment and locations of the business.

The Offer

All Cash Alternative

Shareholders in Allenex, other than the Majority Shareholders, will be able to tender their shares for an all cash consideration of SEK 2.50 per Allenex share.

 

4


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

The Mixed Consideration Alternative

Alternatively, CareDx offers each shareholder in Allenex, other than the Majority Shareholders, the following:

 

    SEK 1.731 per Allenex share (the “Cash Component”); and

 

    0.01298 CareDx Shares per Allenex share (the “Common Stock Component”).

This Mixed Consideration Alternative values each Allenex share at SEK 2.42.5

The Deferred Consideration Alternative

The Majority Shareholders are offered, and have accepted to sell their shares in Allenex in the offer, for:

 

    The Initial Cash Payment of SEK 1.191 per Allenex share;

 

    The Contingent Cash Payments of up to SEK 0.540 per Allenex share, subject to achieving certain commercial and financial milestones in the fourth quarter of 2015 and over the course of 2016; and

 

    0.01298 CareDx Shares per Allenex share.

The consideration under the Deferred Consideration Alternative, assuming all Milestones are achieved, is identical to the Mixed Consideration Alternative and therefore values each Allenex share at SEK 2.426.

If Allenex pays dividends, or makes any other distributions to its shareholders, with a record date occurring prior to the settlement of the Offer, the Offer consideration will be reduced accordingly.

If the Offer is accepted in its entirety under the Mixed Consideration Alternative and together with the Deferred Consideration Alternative, 1,561,344 CareDx Shares will be issued under the Offer, corresponding to approximately 13.1 percent of the CareDx shares outstanding. Following completion of the Offer, if accepted by the non-Majority Shareholders under the Mixed Consideration Alternative in its entirety and by the Majority Shareholders under the Deferred Consideration Alternative, former Allenex shareholders will hold CareDx Shares representing approximately 11.6 percent of the outstanding shares of and voting power in the combined company.7

 

5  The implied offer value of SEK 2.42 per Allenex share is based on i) a SEK/USD exchange rate of 8.4990 as of 15 December 2015, ii) the closing price for CareDx shares of USD 6.25 as of 15 December 2015 (the last trading day prior to announcement of the Offer), and iii) 120,288,448 outstanding Allenex shares.
6  See note 5.
7  Based on 120,288,448 outstanding shares in Allenex and 11,902,363 outstanding shares in CareDx.

 

5


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

Only whole CareDx Shares will be delivered to Allenex shareholders who accept the Offer. Fractions of shares will be combined and sold on the NASDAQ Global Select Market on behalf of the Allenex shareholders concerned, and the average net proceeds will thereafter be distributed among such shareholders in relation to the size of each shareholder’s fraction of a CareDx Share.

CareDx has not paid any cash dividends on its common stock and does not currently intend to pay any cash dividends on common stock in the near future.8

No commission will be charged in respect of the settlement of the Allenex shares tendered to CareDx under the Offer.

For the Allenex shares that are tendered for the Common Stock Component under the Mixed Consideration Alternative, no immediate Swedish tax consequences should arise for individual shareholders of Allenex under certain roll-over relief provisions. Provided that these provisions apply, the tax basis of the divested shares in Allenex will be carried over to the shares in CareDx (i.e., the shares in CareDx will for tax purposes be deemed to have been acquired for an amount equal to the tax basis in the divested shares in Allenex). No immediate Swedish tax consequences should arise for limited liability companies for the Common Stock Component under the Mixed Consideration Alternative, or for the sale of Allenex shares in exchange for CareDx shares pursuant to the Deferred Consideration Alternative, under certain tax deferral provisions. Provided that these provisions apply, a limited liability company may claim a tax deferral of a gain realized on the divestment of Allenex shares in exchange for CareDx shares. For the Allenex shares that are tendered i) for the Cash Component under the Mixed Consideration Alternative and the Initial Cash Payment and Contingent Cash Payments in the Deferred Consideration Alternative or ii) for cash under the All Cash Alternative, the sale of shares in Allenex will be a taxable event that may give rise to a capital gain or a loss. For individuals taxable in Sweden the tax rate for capital income is 30 percent. For limited liability companies capital income is generally taxed as business income at a rate of 22 percent. Allenex shareholders should consult their own tax advisors regarding the Swedish or other tax consequences of electing either alternative, including the consequences of any proposed change in applicable laws.

The Offer is not subject to any financing conditions. CareDx will fund the cash portion of the Offer by utilizing available cash. CareDx has received a binding loan commitment from Oberland Capital SA Davos LLC (“Oberland Capital”) pursuant to which Oberland Capital will lend up to USD 16 million to enable CareDx to repay certain outstanding debt that may be required to be refinanced in connection with the consummation of the Offer.

Drawdowns under the loan commitment with Oberland Capital are subject to the conditions of the Offer being satisfied or waived, which waivers require consent from Oberland Capital, and to certain other customary conditions, such as CareDx not being insolvent. Besides

 

8  Should at some future date a dividend be paid on CareDx’ common stock, the CareDx Shares issued as consideration under the Offer would carry equal rights with respect to such dividend as the CareDx Shares already issued and entitled to dividends, provided that the record date for such dividend occurs after the settlement of the Offer.

 

6


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

these conditions, the loan commitment is not subject to any conditions that CareDx does not control. These other conditions include, in all material respects, that CareDx utilizes the loan to refinance certain outstanding debt, that CareDx perfects security interests, that CareDx’ and its subsidiaries’ aggregated indebtedness does not exceed a certain agreed amount, that CareDx has not breached or violated certain identified limited undertakings in respect of itself or certain material obligations, and that CareDx has complied with its obligations in the loan commitment (including having paid all applicable fees)

At the time of this announcement CareDx does not hold any Allenex shares or any financial instruments that give financial exposure to Allenex shares, nor has CareDx acquired or agreed to acquire (other than pursuant to the agreements with the Majority Shareholders; please see “Undertaking to accept the Offer” below) any Allenex shares or any financial instruments that give financial exposure to Allenex shares during the six months preceding the announcement of the Offer.

Offer value and premium

The All Cash Alternative values each Allenex share at SEK 2.50 and corresponds to a total offer value of approximately SEK 300.7 million.9

The All Cash Alternative represents a premium of:

 

    approximately 24 percent compared to the closing share price of SEK 2.02 for the Allenex share on Nasdaq Stockholm on 15 December 2015, the last trading day prior to announcement of the Offer;

 

    approximately 17 percent compared to the one month volume-weighted average share price of SEK 2.14 for the Allenex share on Nasdaq Stockholm, up to and including 15 December 2015, the last trading day prior to announcement of the Offer;

 

    approximately 16 percent compared to the three month volume-weighted average share price of SEK 2.16 for the Allenex share on Nasdaq Stockholm, up to and including 15 December 2015, the last trading day prior to announcement of the Offer; and

 

    approximately 12 percent compared to the six month volume-weighted average share price of SEK 2.23 for the Allenex share on Nasdaq Stockholm, up to and including 15 December 2015, the last trading day prior to announcement of the Offer.

 

9  120,288,448 outstanding Allenex shares and based on the terms for the All Cash Alternative.

 

7


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

The Mixed Consideration Alternative values each Allenex share at approximately SEK 2.42 and corresponds to a total offer value of approximately SEK 291.1 million.10

The Mixed Consideration Alternative represents a premium of:

 

    approximately 20 percent compared to the closing share price of SEK 2.02 for the Allenex share on Nasdaq Stockholm on 15 December 2015, the last trading day prior to announcement of the Offer;

 

    approximately 13 percent compared to the one month volume-weighted average share price of SEK 2.14 for the Allenex share on Nasdaq Stockholm, up to and including 15 December 2015, the last trading day prior to announcement of the Offer;

 

    approximately 12 percent compared to the three month volume-weighted average share price of SEK 2.16 for the Allenex share on Nasdaq Stockholm, up to and including 15 December 2015, the last trading day prior to announcement of the Offer;

 

    approximately 9 percent compared to the six month volume-weighted average share price of SEK 2.23 for the Allenex share on Nasdaq Stockholm, up to and including 15 December 2015, the last trading day prior to announcement of the Offer.

Recommendation from the Allenex Board of Directors

The Allenex Board of Directors unanimously recommends that Allenex’ shareholders accept the Offer.11

Undertaking to accept the Offer

On 15 December 2015, CareDx signed an agreement with each of the Majority Shareholders Midroc Invest AB, FastPartner AB and Xenella Holding AB, controlling approximately 78 percent of the shares in Allenex, pursuant to which the Majority Shareholders agreed to sell their shares in connection with the Offer for the Deferred Consideration Alternative (and not the All Cash Alternative or the Mixed Consideration Alternative), provided that the Offer is declared unconditional no later than on 8 April 2016.

 

10  See note 2
11  Since the Majority Shareholders have agreed to sell their shares in connection with the Offer (please see “Undertaking to accept the Offer” below), Oscar Ahlgren, Director of the Board of Directors of Midroc Invest AB and Xenella Holding AB, and Sven-Olof Johansson, CEO and main shareholder of Fastpartner AB and Director of the Board of Directors of Xenella Holding AB, have, due to conflict of interests, based on the above mentioned commitments, not participated in the preparations and issues related to the Offer in the Allenex Board of Directors. All other members of the Board of Directors of Allenex, all of which are independent of the company, the management and the major shareholders in the company, have participated in the handling of the issue and the Board of Directors has therefore been quorate.

 

8


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

Conditions to the Offer

In addition to the above, the completion of the Offer would be subject to the following conditions:

 

  (i) the Offer being accepted to such an extent that CareDx becomes the owner of Allenex shares representing not less than 78% of the shares in Allenex;

 

  (ii) no circumstance or circumstances, which CareDx did not have knowledge of at the time of the announcement of the Offer, having occurred which, individually or in the aggregate, would have or could reasonably be expected to have a material adverse effect on the sales, results, liquidity, equity ratio, equity or assets of Allenex and its subsidiaries, taken as a whole;

 

  (iii) neither the Offer, nor the acquisition of Allenex being rendered wholly or partially impossible or significantly impeded as a result of legislation or other regulation, any decision by court or public authority, or any other similar circumstance which is actual or can reasonably be expected, and which CareDx could not reasonably have foreseen at the time of the announcement of the Offer;

 

  (iv) Allenex not taking any action that is likely to impair the prerequisites for making or completing the Offer; and

 

  (v) no information made public by Allenex or disclosed by Allenex to CareDx prior to the time of the announcement of the Offer being materially inaccurate, incomplete or misleading, and Allenex having made public all material information which should have been made public by it.

CareDx reserves the right to withdraw the Offer in the event that it becomes clear that one or more of the conditions is or are not or cannot be satisfied, provided that, in respect of conditions (ii)-(v), such withdrawal will only be made if the non-satisfaction, individually or in the aggregate, is of material importance to CareDx’ acquisition of Allenex shares.

CareDx also reserves the right to waive, in whole or part, any conditions to the completion of the Offer.

Brief description of CareDx

CareDx, based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high value diagnostic surveillance solutions for transplant recipients. The Company has commercialized AlloMap, a gene expression test that aids clinicians in identifying heart transplant recipients with stable graft function who have a low probability of moderate/severe acute cellular rejection. CareDx is also pursuing the development of additional products for post-transplant monitoring.

 

9


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

AlloMap currently addresses a USD 100 million+ market in the U.S. The company is developing a similar monitoring test for kidney transplant recipients. The U.S. kidney transplant market opportunity represents approximately USD 1 billion or ~10x the U.S. heart transplant market.

As of 30 September 2015, CareDx had a total of 91 employees. Total revenue was USD 27 million in 2014 and USD 21 million for the first 9 months in 2015.

CareDx was listed in July 2014 and the shares are traded on Nasdaq Global Markets. CareDx’ market capitalization as of 15 December 2015 was approximately USD 74 million.

Financial effects for CareDx

The below unaudited financial information relates to information taken from each company’s reported financial results. CareDx reports in accordance with U.S. GAAP while Allenex reports in accordance with IFRS and differences in accounting policies may occur. The financial information is only an aggregation of financial information for the various businesses for the relevant time periods in order to provide an illustration of the combined company’s sales and earnings under the assumption that the activities were conducted within the same group from the beginning of each period presented.

 

Full year 2014 (SEKm)12

   CareDx      Allenex      Adjustments      The
combined
company
 

Revenue

     232.1         135.5         —           367.6   

Operating profit

     10.6         22.9         —           33.5   

Net income

     6.6         15.2         —           21.8   

Employees (no.)

     68         55         —           123   

The aggregation should not be viewed as pro forma since adjustments have not been made for the effects of future acquisitions analyses, differences in accounting policies and transaction costs. Pro forma financial information for the combined company under U.S. GAAP will be included in the offer document relating to the Offer, and may vary significantly from the combined financial information contained herein.

 

12  All USD amounts have been converted into SEK based on a USD/SEK exchange rate of 8.1970.

 

10


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

Due diligence

CareDx has conducted a due diligence review customary and appropriate in connection with the preparation of the Offer. Allenex has advised CareDx that, CareDx has not received any non-public price-sensitive information in connection with the due diligence review. In addition, Allenex has performed a customary and appropriate due diligence review of certain business, financial and legal information relating to CareDx, in accordance with applicable Swedish rules.

Statement from the Swedish Securities Council in relation to the Offer

The Swedish Securities Council (Sw. Aktiemarknadsnämnden) has approved an extension of the period for preparing and filing the offer document with the Swedish Financial Supervisory Authority (the “SFSA”) (Sw. Finansinspektionen) from four weeks after the announcement of the Offer, to six weeks after such date. The reasons for the extension are the time-consuming process of preparing pro forma financial statements, including converting Allenex’ financial statements from IFRS to U.S. GAAP (see ruling AMN 2015:42). CareDx may request an additional extension if necessary. In addition, the Swedish Securities Council has, inter alia, granted CareDx an exemption from the rule set out in provision II.10 of the Takeover Rules according to which the same compensation per share shall be offered to all shareholders of the same kind with regards to Majority Shareholders only being offered the Deferred Consideration Alternative. The Swedish Securities Council also stated that it is not contrary to good stock exchange practice to exclude information in the offer documentation regarding the specific content of the Milestones and the size of individual Contingent Cash Payments (see ruling AMN 2105:42).

Indicative timetable

 

    9 February 2016: Estimated date for publication of the Offer document

 

    10 February – 2 March 2016: Estimated acceptance period

 

    9 March 2016: Estimated date of settlement

CareDx reserves the right to extend the acceptance period as well as to postpone the date of settlement. CareDx will announce any extension of the acceptance period and/or postponement of the date of settlement by a press release in accordance with applicable laws and regulations.

The Offer does not require pre-clearance filing with competition authorities.

Compulsory acquisition and delisting

If CareDx becomes the owner of more than 90 percent of the shares of Allenex, CareDx intends to initiate a compulsory acquisition procedure with respect to the remaining shares in Allenex under the Swedish Companies Act (Sw. aktiebolagslagen (2005:551)). Furthermore, CareDx intends to promote a delisting of the Allenex shares from Nasdaq Stockholm following closing of the transaction.

 

11


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

Applicable law and disputes

The Offer, as well as the agreements entered into between CareDx and the Allenex shareholders as a result of the Offer, shall be governed and construed in accordance with substantive Swedish law. Any dispute regarding the Offer, or which arises in connection therewith, shall be exclusively settled by Swedish courts, and the City Court of Stockholm (Sw. Stockholms tingsrätt) shall be the court of first instance.

The Takeover Rules and the Swedish Securities Council’s (Sw. Aktiemarknadsnämnden) rulings and statements on the interpretation and application of the Takeover Rules, including, where applicable, the Swedish Securities Council’s rulings and statements on the interpretation and application of the formerly applicable Rules on Public Offers for the Acquisition of Shares issued by the Swedish Industry and Commerce Stock Exchange Committee (Sw. Näringslivets Börskommitté), are applicable to the Offer. Furthermore, CareDx has, in accordance with the Swedish Takeover Act (Sw. lag (2006:451) om offentliga uppköpserbjudanden på aktiemarknaden), on 15 December 2015 contractually undertaken towards Nasdaq Stockholm to comply with said rules, rulings and statements and to submit to any sanctions that can be imposed on CareDx by Nasdaq Stockholm in the event of a breach of the Takeover Rules. On 16 December 2015, CareDx informed the SFSA of the Offer and the abovementioned undertakings towards Nasdaq Stockholm.

Advisers

CareDx has retained ABG Sundal Collier AB as financial adviser; Baumgarten Byström Rooth & Tallavaara Advokater AB as Swedish legal adviser; and Wilson Sonsini Goodrich & Rosati as U.S. legal adviser in connection with the Offer.

 

 

Brisbane, California, USA 16 December 2015 (CET)

CareDx, Inc.

The Board of Directors

CareDx discloses the information provided herein pursuant to the Takeover Rules. The information was submitted for publication on 16 December 2015, 07:30 a.m. CET.

 

 

 

12


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

Information about the Offer

Information about the Offer is made available at: www.caredx.com.

CareDx will host a conference call to discuss the Offer on 16 December 2015 at 08:00 a.m. Eastern Standard Time (2:00 p.m. Central European Time). Interested parties may join the conference call by dialing 855-420-0616 (within the U.S.) or +1 678-304-6848 (outside of the U.S.). The participant passcode is 6934784. The Audio Webcast will also be available at www.caredx.com.

For further information, please contact:

 

Media (Europe):

Publik – Catarina Wigén

+46 706 775 937

catarina.wigen@publik.se

 

Media (US):

CareDx – Molly Martell

+1 415 287 2397

mmartell@caredx.com

  

Investors (Europe):

ABG Sundal Collier – Sebastian Alexanderson

+46 856 628 679

sebastian.alexanderson@abgsc.se

 

Investors (US):

Westwicke – Leigh Salvo

+1 415 513 1281

leigh.salvo@westwicke.com

Important information

This is a translation of the original Swedish language press release. In the event of discrepancies, the original Swedish wording shall prevail.

The Offer, pursuant to the terms and conditions presented in this press release, is not being made to persons whose participation in the Offer requires that an additional offer document be prepared or registration effected or that any other measures be taken in addition to those required under Swedish and regulations.

This press release and any related Offer documentation are not being distributed and must not be mailed or otherwise distributed or sent in or into any country in which the distribution or offering would require any such additional measures to be taken or would be in conflict with any law or regulation in such country, any such action will not be permitted or sanctioned by CareDx. Any purported acceptance of the Offer resulting directly or indirectly from a violation of these restrictions may be disregarded.

 

13


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the U.S. Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

The Offer is not being and will not be made, directly or indirectly, in or into, or by use of mail or any other means or instrumentality of interstate or foreign commerce of, or any facilities of a national securities exchange of, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa. This includes, but is not limited to facsimile transmission, electronic mail, telex, telephone, the internet and other forms of electronic transmission. The Offer cannot be accepted and shares may not be tendered in the Offer by any such use, means, instrumentality or facility of, or from within Australia, Hong Kong, Japan, Canada, New Zealand or South Africa or by persons located or resident in Australia, Hong Kong, Japan, Canada, New Zealand or South Africa. Accordingly, this press release and any related Offer documentation are not being and should not be mailed or otherwise transmitted, distributed, forwarded or sent in or into Australia, Hong Kong, Japan, Canada, New Zealand or South Africa or to any Australian, Hong Kong, Japanese, Canadian, New Zealand or South African persons or any persons located or resident in Australia, Hong Kong, Japan, Canada, New Zealand or South Africa.

Any purported tender of shares in an Offer resulting directly or indirectly from a violation of these restrictions will be invalid and any purported tender of shares made by a person located in Australia, Hong Kong, Japan, Canada, New Zealand or South Africa or any agent fiduciary or other intermediary acting on a non-discretionary basis for a principal giving instructions from within Australia, Hong Kong, Japan, Canada, New Zealand or South Africa will be invalid and will not be accepted. Each holder of shares participating in the Offer will represent that it is not an Australian, Hong Kong, Japanese, Canadian, New Zealand or South African person, is not located in Australia, Hong Kong, Japan, Canada, New Zealand or South Africa and is not participating in such Offer from Australia, Hong Kong, Japan, Canada, New Zealand or South Africa or that it is acting on a non-discretionary basis for a principal that is not an Australian, Hong Kong, Japanese, Canadian, New Zealand or South African person, that is located outside Australia, Hong Kong, Japan, Canada, New Zealand or South Africa and that is not giving an order to participate in such offer from Australia, Hong Kong, Japan, Canada, New Zealand or South Africa. CareDx will not deliver any consideration from the Offer into Australia, Hong Kong, Japan, Canada, New Zealand or South Africa.

This press release is not being, and must not be, sent to shareholders with registered addresses in Australia, Hong Kong, Japan, Canada, New Zealand or South Africa. Banks, brokers, dealers and other nominees holding shares for persons in Australia, Hong Kong, Japan, Canada, New Zealand or South Africa must not forward this press release or any other document received in connection with the Offer to such persons.

 

14


The Offer is not being made, and this press release may not be distributed, directly or indirectly, in or into, nor will any tender of shares be accepted from or on behalf of holders in, Australia, Hong Kong, Japan, Canada, New Zealand or South Africa, or any other jurisdiction in which the making of the Offer, the distribution of this press release or the acceptance of any tender of shares would contravene applicable laws or regulations or require further offer documents, filings or other measures in addition to those required under Swedish law.

The issuance of shares in connection with the Offer have not been registered under the U.S. Securities Act of 1933, as amended, or the securities laws of any state of the United States, and will be issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933, as amended, provided by Rule 802 thereunder. The Company will furnish to the Securities and Exchange Commission a Form CB in respect of the offer and sale of such shares. The Offer will otherwise be made in accordance with the applicable regulatory requirements in Sweden.

 

The acceptance period for the Offer for shares of Allenex described in this communication has not commenced.

In connection with the proposed combination of CareDx and Allenex, an offer document related to the Offer will be filed with and published by the SFSA. Shareholders of Allenex should read the above referenced documents and materials carefully when such documents and materials become available, as well as other documents filed with the SFSA, because they will contain important information about the transaction.

Forward-looking information

Statements in this press release relating to future events, status and circumstances, including statements regarding future financial or operating performance, development, commercial activities, growth and other projections as well as benefits of the Offer, are forward-looking statements. These statements may generally, but not always, be identified by the use of words such as “anticipates,” “expects,” “believes,” continue,” “intends,” “target,” “projects,” “contemplates,” “plans,” “seeks,” “estimates,” “could,” “should,” “feels,” “will,” “would,” “may,” “can,” “potential” or similar expressions or variations, or the negative of these terms. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. There can be no assurance that actual results will not differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, many of which are outside the control of CareDx. These risks and uncertainties include the risk that the closing conditions are not satisfied, and that the transaction may not close; that Allenex’ and CareDx’ businesses will not be integrated successfully; that synergies will not be realized or realized to the extent anticipated; that the combined company will not realize its financing or operating strategies; that products launched by the combined company are not successfully commercialized or commercialization efforts are slower than anticipated; that the benefits of complementary product portfolios are not be realized; that litigation in respect of either company or the transaction could arise; that disruption caused by the combined company make it difficult to maintain certain strategic relationships; and that interest in current product offerings is not sustained and the combined company is unable to maintain current revenue levels. These risks and uncertainties also include those risks and uncertainties stated in CareDx’ filings with the U.S. Securities and Exchange Commission located at www.sec.gov and that will be discussed in the offer document to be filed with the SFSA at a future date by CareDx. CareDx cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. Any forward-looking statements contained in this press release speak only as of the date on which they were made and CareDx has no obligation (and undertakes no such obligation) to update or revise any of them, whether as a result of new information, future events or otherwise, except for in accordance with applicable laws and regulations.

 

15

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