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Roche and Foundation Medicine announced today that they will enter into a broad and strategic collaboration in the field of molecular information in oncology.
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The Collaboration leverages both companies’ strengths to advance the progress of personalized treatments for patients with cancer.
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Roche to acquire a majority interest in Foundation Medicine (FMI) of up to 56.3% on a fully diluted basis through a tender and acquisition of newly issued shares.
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Roche will tender for approximately 15.6 million Foundation Medicine shares at USD 50 per share with an aggregate tender value of approximately USD 780 million.
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Roche will also invest USD 250 million in Foundation Medicine by acquiring 5 million newly issued shares at USD 50 per share.
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Partnership includes both a broad R&D collaboration with the potential for more than USD 150 million funding by Roche to accelerate FMI’s new product development initiatives, optimize treatments for oncology patients, and better design and understand the results of clinical trials based on molecular information, as well as commercial collaboration agreements aimed at expanding the global sales efforts for FMI’s current and future products.
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Michael J. Pellini, MD, FMI’s president and CEO, and FMI’s management team, will continue to lead FMI post-closing.
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Company will maintain operational independence.
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Roche to obtain minority representation on the expanded FMI Board of Directors. Roche and FMI Boards of Directors have unanimously approved the transaction.
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1.
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Why is Roche entering into a partnership with Foundation Medicine?
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2.
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What are the terms of the deal?
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The transaction consists of a broad, strategic collaboration in the field of molecular information and genomic analysis between Foundation Medicine and Roche. The collaboration will enhance Roche’s oncology clinical development efforts across multiple areas including cancer immunology, leveraging both companies’ strengths to advance the progress of personalized treatments for cancer patients, and standardize Roche’s clinical trial data collection and analysis.
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As part of this transaction Roche will also acquire majority ownership in Foundation Medicine through a combination of a capital increase (providing Foundation Medicine with USD 250 million in cash) and a tender offer, resulting in ownership of up to 56.3% of the fully diluted (including the capital increase) Foundation Medicine shares.
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The collaboration as well as the capital increase are dependent upon the successful outcome of the tender offer and shareholder vote. They are all cross-conditional and become effective at once.
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3.
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What benefits will Roche receive by paying such a significant premium in light of the fact that Roche will not gain operational control of the target?
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4.
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What are the collaborative efforts Roche and Foundation Medicine will be undertaking and how unique are they?
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5.
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Couldn’t Roche have just entered into a separate collaboration agreement to receive the strategic benefits of access to Foundation Medicine capabilities/expertise without the need to pay a premium?
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The envisaged collaborations between Roche and Foundation Medicine are broad and deep and will require significant resources, commitments and investments. Therefore it is important for Roche to build a strong relationship with Foundation Medicine. The deal provides Roche with majority ownership of Foundation Medicine.
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6.
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Why did Roche agree to a minority in the Foundation Medicine’ Board of Directors despite agreeing to such a large control premium with a 50%+ financial ownership? What is the reason for not obtaining operational control?
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7.
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Will you eventually fully take over Foundation Medicine?
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The proposed structure supports Foundation Medicine’ current business model and further fosters its pioneering and entrepreneurial approach to molecular information and genomics analysis. Roche has vast experience in terms of flexible and creative deal structures.
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8.
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If concern over a full acquisition is losing the innovation and nimbleness that exist today at Foundation Medicine, how will that be different in 3 years when you can buy the remainder of the company?
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Foundation Medicine business model is in a new and rapidly evolving field of molecular information in oncology. This proposed structure supports Foundation Medicine by assuring the company maintains the agility and flexibility needed to develop their business. The majority ownership of Roche will allow Roche to participate in the future success of Foundation Medicine as we believe in the future importance of molecular information.
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Legal restrictions usually come with time limitations and the cessation of the stand-still provision does not necessarily mean that Roche would acquire Foundation Medicine in full or divest its holdings.
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9.
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Can you explain what relationship Roche has had with Foundation Medicine so far?
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Roche has been working with Foundation Medicine through the Lung Cancer Master Protocol, or Lung-MAP (SWOG S1400), which is a multi-drug, multi-arm, biomarker-driven squamous cell lung cancer clinical trial that uses cutting-edge genomic profiling to match patients to investigational treatments that may target the genomic alterations, or mutations, found to be driving the growth of their cancer.
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10.
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Who are the financial advisors?
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Roche has been advised by Citibank. Foundation Medicine has been advised by Goldman Sachs.
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11.
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Who are the legal advisors?
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Foundation Medicine in general
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12.
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What is Foundation Medicine?
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13.
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How many people does Foundation Medicine employ? Where?
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14.
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What impact does this partnership have on current employees of Foundation Medicine?
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Foundation Medicine will continue to be operationally independent.
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15.
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Are there any option programs being implemented for retention of key personnel?
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There is no retention program. Foundation Medicine, as an operationally independent company, will continue granting options and RSUs in the ordinary course of business.
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16.
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Will Foundation Medicine be integrated into Roche?
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17.
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Will Foundation Medicine become a part of the Pharmaceutical or the Diagnostics Division of Roche? Or is this the beginning of a third Division for the Roche Group?
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18.
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Will you retain the Foundation Medicine name?
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Foundation Medicine remains a listed company under the Foundation Medicine name.
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Commercial aspects/Technology
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19.
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What is the product or service that Foundation Medicine offers?
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The key Foundation Medicine products are the next generation sequencing panels FoundationOne and FoundationOne Heme for solid and hematologic malignancies respectively as well as the Interactive Cancer Explorer.
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20.
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Who are Foundation Medicine’ customers? Is Roche already a customer of Foundation Medicine?
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21.
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Although Foundation Medicine will be able to continue to collaborate/partner outside of the defined “field of operation,” other non-Roche pharma players may be concerned about Roche learning competitively sensitive information. How will Roche/Foundation Medicine protect against these concerns which could potentially negatively impact value?
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22.
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If collaborations with other pharma companies are protected through a ‘firewall’ as you do successfully at Ventana, why can’t you take full control of Foundation Medicine?
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23.
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What is the contingency plan for the Roche / Foundation Medicine collaboration in the event Illumina refuses to sell its sequencers to Foundation Medicine as a result of Illumina viewing Foundation Medicine as a potential competitor in the field of cancer diagnostics?
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24.
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Are there panels that are being developed exclusively for Roche use?
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25.
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Did you choose the right company? Who are the competitors? What is the advantage of Foundation Medicine vs. Competitors?
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26.
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What role do Roche’s own technologies like Genia and/or PacBio have in this deal?
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Roche Diagnostics is committed to developing an integrated genomics portfolio that provides our customers with a complete testing solution. At the moment it is too early to speculate on any potential future relevance with regards to Foundation Medicine.
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27.
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Is the Roche (Genia) sequencing technology compatible with Foundation Medicine panels and technology?
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28.
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Roche recently announced the acquisition of Ariosa which also has a CLIA lab-based operation. Is this a strategic shift of Roche towards CLIA-lab based genomic analysis and molecular information?
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The key driver for the deal between Roche and Foundation Medicine is the importance of molecular information to characterize a tumor. This is critical in Roche’s ability to develop the best therapies for patients, as well as to determine the best combinations for clinical development.
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29.
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Are there compliance restrictions to how Pharma or DIA at Roche can promote these tests?
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At the moment, Foundation Medicine operates as a CLIA lab and sells a service. Foundation Medicine markets the service without highly-specific clinical claims. The workflow that Foundation Medicine has developed is considered a lab developed test, and as such, neither Roche nor Foundation Medicine can promote the service or the “test” with any specific clinical claims. The lab developed test is governed by the new FDA guidance, and all promotional claims for these high-risk tests must be substantiated with submitted data via the FDA submission process.
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30.
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Will you use Foundation Medicine’ brand ex-US?
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31.
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What is the regulatory environment for such panels in the US? Ex-US?
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32.
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How will you gain reimbursement?
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33.
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How much do the tests provided by Foundation Medicine cost?
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The list price of FoundationOne is $5,200. The list price of FoundationOne Heme is $ 7,200.
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34.
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You mention clinical practice – how are these tests accepted in clinical practice/guidelines today? In the future?
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35.
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What is in Foundation Medicine’ pipeline?
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36.
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What is the anticipated timing of the coverage decision by Medicare?
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37.
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Other than the Illumina platform, what other platforms has Foundation Medicine developed these tests on?
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38.
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How far is the company in developing kit versions of the tests?
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Foundation Medicine is still exploring the proper format for kit versions of the tests.
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Impact on Roche
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39.
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How does this fit with Roche’s existing offering including tissue testing?
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The Foundation Medicine technology is complementary to Roche’s current offerings. Foundation Medicine technology provides Roche with a comprehensive genomic profile of a tumor whereas tissue diagnostics analyses expression markers needed to provide a better overall view of the tumor. Currently, Roche Tissue Diagnostics products are registered and marketed for clinical diagnostics purposes while Foundation Medicine is intended to be used in translational research and medicine. At the moment, Foundation Medicine operates as a CLIA lab and sells a service. Foundation Medicine markets the service without highly-specific clinical claims. The lab developed test is governed by the new FDA guidance, and all promotional claims for these high risk tests must be substantiated with submitted data via the FDA submission process. In the US, Foundation Medicine will seek FDA approval of its existing platforms. The FoundationOnce test already has CE marking.
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40.
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In the future, will PCR and other tissue diagnostics still be needed? Does Foundation Medicine cannibalize existing technology at Roche?
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Roche views PCR, Tissue Diagnostics and Sequencing as synergistic. The market and medical community are continuing to determine the clinical value and rate of reimbursement for large sequencing panels currently used in a research setting. There is a clear place for Foundation Medicine panels in clinical trials and clinical research. IVD approved PCR will continue to be the gold standard for Companion Diagnostics in the near future and the significance of tumor heterogeneity is not fully understood at this time. Tissue morphology will remain to be an important part of tumor diagnosis and therefore we see current tissue diagnostics to be complementary to genetic sequencing of the tissue.
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41.
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How will the company be consolidated in the financial reporting of Roche? Pharma? DIA? Group?
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42.
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Does this impact guidance for 2015?
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43.
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What is the impact on cash flow and margins?
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44.
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Does this change your M&A strategy going forward?
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This is part of Roche’s M&A strategy. Roche will continue to seek access to external innovation and technologies through partnering as well as small to mid-sized acquisitions.
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45.
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How will you finance the deal?
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46.
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If you take majority ownership but not operational management, how do you protect the interests of Roche shareholders?
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Roche and Foundation Medicine have agreed that Foundation Medicine should remain operationally independent, as this will give Foundation Medicine the necessary autonomy to navigate and adapt in the emerging molecular information market. Roche is well experienced and was able to prove success with somewhat similar deal structures (Chugai, Genentech).
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47.
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Will the collaboration with Foundation Medicine be relevant to all oncology clinical trials of Roche going forward?
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48.
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Will this collaboration be extended beyond oncology?
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49.
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Does the partnership extend to all R&D units of the Roche Group including Chugai?
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50.
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What does this mean for Roche’s sequencing strategy?
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51.
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Is an Illumina bid off the table now?
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We do not comment on potential acquisitions.
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Tender offer
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52.
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Does Roche already own any shares in Foundation Medicine?
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The Roche Venture fund is currently holding 414’823; this represents 1.1% on a fully diluted basis (calculated post intended capital increase).
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53.
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Please describe the details of the transaction. What are the terms and conditions? What are the timelines?
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54.
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Who will be on the board of Foundation Medicine?
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Upon the closing, Foundation Medicine’ board of directors will be increased to 9 directors and will include three designees of Roche (including Daniel O’Day), 5 venture capital representatives and independent directors and Michael Pellini, MD, who will remain as Chief Executive Officer. The other board members will be announced in due course.
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55.
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Why is Roche acquiring a minimum of 52.4% and a maximum of 56.3%? What is the rationale for these specific figures?
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Roche and Foundation Medicine have agreed contractual arrangements that will generally maintain Roche’s majority ownership, subject to Roche’s decision to sell-down following three years from
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56.
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What agreements are there exactly, that form part of the deal and what do they stipulate?
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There are two areas, the Collaboration and Transaction aspects. The Collaboration has two key components: a Research & Development agreement and a Commercial agreement:
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a.
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R&D agreement that includes:
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b.
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Commercial agreement that includes:
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c.
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An ex US commercial agreement under which Roche has the right to commercialize Foundation Medicine' current and certain future clinical diagnostic commercial products outside of the United States.
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Transaction Agreement: setting forth the terms and conditions of the transaction including primary investment and tender offer
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Investor Rights Agreement: setting forth the governance of Foundation Medicine and the rights and obligations of the parties following closing of the transaction
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Tender and Support Agreement: setting forth the support, voting and tender obligations of certain current venture capital shareholders of Foundation Medicine
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57.
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Can you precisely explain what the agreed stand-still provision will foresee?
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The agreed stand-still provision addresses Roche’s ability to potentially later buy-out Foundation Medicine’ minority shareholders. Roche generally cannot increase its ownership position within the first three years following closing. During the following two years Roche can acquire the remaining shares of Foundation Medicine only with the support of Foundation Medicine directors unaffiliated with Roche and a majority of the non-Roche shareholders. After the fifth anniversary of closing Roche would be free to make an offer subject to acceptance by the majority of Foundation
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58.
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Will you increase the price of your offer?
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The conditions of the offer have been approved by both parties’ Boards of Directors. The Foundation Medicine’ Board of Directors has unanimously recommended to Foundation Medicine’ shareholders that they accept the offer. We believe the offered terms are full and fair.
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Further information will be filed with the SEC/be publicly available.
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59.
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Please explain why you are willing to pay this substantial premium for Foundation Medicine?
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The conditions of the offer have been approved by both parties’ Boards of Directors and we believe the offered terms are full and fair for both parties.
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60.
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Who are the key shareholders of Foundation Medicine?
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The largest shareholders are:
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Third Rock (17%)
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Fidelity (11%)
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Gilder Gagnon Howe (11%)
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Kleiner Perkins (10%)
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Google Ventures (4%)
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61.
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Have you spoken to the key shareholders of Foundation Medicine? Are they willing to tender their shares?
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62.
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What do you recommend shareholders of Foundation Medicine to do? Tender their shares for what you state is an attractive (“full and fair”) offer, or to keep their shares for the long run to realize on the long-term promise of this transaction?
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This transaction has received the unanimous Foundation Medicine Board of Directors approval and support of the transaction and the unanimous recommendation to Foundation Medicine’ shareholders to tender the shares.
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63.
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How long do you expect the tender offer to last? By when shall it be concluded?
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The tender offer will be open initially for 20 business days, but may be extended until all of the conditions (including receipt of Foundation Medicine shareholder approval) have been satisfied. All
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64.
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What conditions need to be met for this transaction to be completed? When will the deal close?
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65.
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Do you anticipate any hurdles (such as SEC and/or anti-trust authorities) in this transaction?
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