UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE TO
Tender Offer Statement under Section 14(d)(1) or 13(e)(1)
of the Securities Exchange Act of 1934
AVEXIS, INC.
(Name of Subject Company (Issuer))
NOVARTIS AM MERGER CORPORATION
an indirect wholly-owned subsidiary of
NOVARTIS AG
(Name of Filing Persons (Offerors))
Common Stock, $0.0001 Par Value
(Title of Class of Securities)
05366U100
(CUSIP Number of Class of Securities)
Felix R. Ehrat
Group General Counsel
Novartis AG
Lichstrasse 35
CH-4056 Basel
Switzerland
Telephone: +41-61-324-1111
(Name, Address, and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf
of Filing Persons)
Copy to:
Joseph E. Gilligan
Joseph G. Connolly, Jr.
Hogan Lovells US LLP
555 13th Street, NW
Washington, DC 20002
Telephone: +1 (202) 637-5600
Calculation of Filing Fee
Transaction Valuation |
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Amount of Filing Fee |
Not Applicable |
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Not Applicable |
o Check the box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify the filing with which the offsetting fee was previously paid. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing.
Amount Previously Paid: None |
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Filing Party: N/A |
Form of Registration No.: N/A |
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Date Filed: N/A |
x Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.
Check the appropriate boxes below to designate any transactions to which the statement relates:
x third-party tender offer subject to Rule 14d-1.
o issuer tender offer subject to Rule 13e-4.
o going-private transaction subject to Rule 13e-3.
o amendment to Schedule 13D under Rule 13d-2.
Check the following box if the filing is a final amendment reporting the results of the tender offer. o
If applicable, check the appropriate box(es) below to designate the appropriate rule provision(s) relied upon:
o Rule 13e-4(i) (Cross-Border Issuer Tender Offer)
o Rule 14d-1(d) (Cross-Border Third-Party Tender Offer)
The pre-commencement communication filed under cover of this Tender Offer Statement on Schedule TO is being filed by Novartis AG, a company organized under the laws of Switzerland (Parent), and Novartis AM Merger Corporation (Purchaser), a Delaware corporation and an indirect wholly-owned subsidiary of Parent, pursuant to General Instruction D to Schedule TO related to a planned tender offer by Purchaser for all of the outstanding shares of common stock, par value $0.0001 per share, of AveXis, Inc., a Delaware corporation (the Company). The planned tender offer will be made pursuant to an Agreement and Plan of Merger, dated as of April 6, 2018, by and among Purchaser, Parent and the Company.
Important Information and Where To Find It
This announcement is neither an offer to purchase nor a solicitation of an offer to sell securities. The tender offer for the shares of common stock of the Company described in this announcement has not commenced. At the time the tender offer is commenced, Parent and Purchaser will file, or will cause to be filed, a Schedule TO Tender Offer Statement with the U.S. Securities and Exchange Commission (the SEC) and the Company will file a Schedule 14D-9 Solicitation/Recommendation Statement with the SEC, in each case with respect to the tender offer. The Schedule TO Tender Offer Statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the Schedule 14D-9 Solicitation/Recommendation Statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials and all other documents filed by, or caused to be filed by, Parent and Purchaser and the Company with the SEC will be available at no charge on the SECs website at www.sec.gov. The Schedule TO Tender Offer Statement and related materials also may be obtained for free under the InvestorsFinancial Data section of Parents website at https://www.novartis.com/investors/financial-data/sec-filings. The Schedule 14D-9 Solicitation/Recommendation Statement and such other documents also may be obtained for free from the Company under the Investor + Media section of the Companys website at http://investors.avexis.com/phoenix.zhtml?c=254285&p=irol-IRHome.
Safe Harbor for Forward-Looking Statements
This announcement contains forward-looking statements that can generally be identified by words such as to acquire, to transform, candidate, potential, Breakthrough Therapy Designation, PRIME designation, Sakigake, expected, offers, to accelerate, future, ongoing, would, potentially, believe, can, hopefully, excited, pipeline, Orphan Drug Designation, would, ambition, priorities, to strengthen, opportunity, pending, will, expects, subject to, planned, or similar expressions, or by express or implied discussions regarding the potential outcome of the tender offer for the shares of the Company, to be commenced by Parent and Purchaser, and the potential impact on Parent of the proposed acquisition, including express or implied discussions regarding potential future sales or earnings of Parent, and any potential strategic benefits, synergies or opportunities expected as a result of the proposed acquisition; and regarding potential marketing approvals, new indications or labeling for the potential, investigational or approved products described in this announcement, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. There can be no guarantee that the proposed tender offer or the acquisition described in this announcement will be completed, or that it will be completed as currently proposed, or at any particular time. Neither can there be any guarantee that Parent or any potential products which would be obtained with the Company will achieve any particular future financial results, or that Parent will be able to realize any of potential strategic benefits, synergies or opportunities as a result of the proposed acquisition. Nor can there be any guarantee that the potential, investigational or approved products described in this announcement will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential acquisition described in this announcement, as well as potential regulatory actions or delays with respect to the development of the products described in this announcement; the potential that the strategic benefits, synergies or opportunities expected from the proposed acquisition may not be realized or may take longer to realize than expected; the successful integration of the Company into the Novartis Group subsequent to the closing of the transaction and the timing of such integration; potential adverse reactions to the proposed transaction by customers, suppliers or strategic partners; dependence on key Company personnel and customers; the uncertainties inherent in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; the particular prescribing preferences of physicians and patients; uncertainties regarding actual or potential legal proceedings, including, among others, potential legal proceedings with respect to the proposed acquisition; and other risks and factors referred to in Parents current Form 20-F on file with the US Securities and Exchange Commission. Parent is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
April 9, 2018
Dear AveXis Team,
I wanted to share with you my excitement about the opportunities ahead of us as we announce the signing of an agreement and plan of merger between our two companies.
AveXis has built a team with exceptional depth of experience and shares our aspiration to deliver breakthrough transformative innovation in areas of high unmet medical need. I am very impressed with the tremendous progress you have made in bringing gene therapy out of the lab and into the clinical setting for people suffering from devastating, life-threatening neurological disorders such as SMA, as well as your pipeline of gene therapies and your manufacturing platform.
As a physician-scientist, drug developer, and father of two young boys, I am particularly excited about the great potential AVXS-101 has to improve and extend lives and to bring positive change for children suffering from SMA and their families.
You are a recognized leader in neuroscience, and I commend you on your courage, entrepreneurial spirit and scientific excellence to achieve further breakthroughs in disease areas such as SMA, ALS and Rett Syndrome.
At Novartis, we believe that our people are our greatest asset. We are building a culture that allows everyone to feel inspired by our purpose to reimagine medicine and feel empowered to achieve their personal and professional goals. Science and data are at the core of what we do, and our dedication to bringing transformative innovation to patients around the world is what drives us. AveXis also demonstrates these values.
Imagine the possibilities resulting from the opportunity to combine our cell and gene platforms and neuroscience pipelines, and to leverage your deep expertise together with our 70-year heritage in neuroscience, global reach and resources ultimately enabling us to bring more innovative treatments like AVXS-101 to patients around the world faster.
There are still steps ahead of us to complete our transaction which is expected to close in mid-2018. Until then we will operate as separate and independent companies.
However, I wanted to take the opportunity to share with you how excited we are at Novartis by the opportunity to join forces for a common purpose, in service of patients, scientific innovation and the bright and dedicated people who make both of our companies exceptional and rewarding places to work.
Looking forward to a bright future.
Best regards,
Vas Narasimhan
Legal Disclaimer
In connection with the proposed acquisition, Novartis and an indirect wholly-owned subsidiary of Novartis (Purchaser) will commence a tender offer for the outstanding shares of common stock of Avexis, Inc. (the Company). This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities. The tender offer for the shares of common stock of the Company has not commenced. At the time the tender offer is commenced, Novartis and Purchaser will file, or will cause to be filed, a Schedule TO Tender Offer Statement with the U.S. Securities and Exchange Commission (the SEC) and the Company will file a Schedule 14D-9 Solicitation/Recommendation Statement with the SEC, in each case with respect to the tender offer. The Schedule TO Tender Offer Statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the Schedule 14D-9 Solicitation/Recommendation Statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials and all other documents filed by, or caused to be filed by, Novartis and Purchaser and the Company with the SEC will be available at no charge on the SECs website at www.sec.gov. The Schedule TO Tender Offer Statement and related materials also may be obtained for free under the InvestorsFinancial Data section of Novartis website at https://www.novartis.com/investors/financial-data/sec-filings. The Schedule 14D-9 Solicitation/Recommendation Statement and such other documents also may be obtained for free from the Company under the Investor + Media section of the Companys website at http://investors.avexis.com/phoenix.zhtml?c=254285&p=irol-IRHome.
Client Id: 77 THOMSON REUTERS STREETEVENTS EDITED TRANSCRIPT NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 EVENT DATE/TIME: APRIL 09, 2018 / 6:00AM GMT THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
Client Id: 77 APRIL 09, 2018 / 6:00AM, NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 CORPORATE PARTICIPANTS Harry Kirsch Novartis AG - CFO Janneke van der Kamp Nigel Sheail Samir Shah Novartis AG - Global Head IR Vasant Narasimhan Novartis AG - CEO CONFERENCE CALL PARTICIPANTS Luisa Caroline Hector Exane BNP Paribas, Research Division - Pharma Research Analyst Matthew Weston Crédit Suisse AG, Research Division - MD and Co-Head of European Pharmaceutical Equity Research Michael Leuchten UBS Investment Bank, Research Division - Co-Head of Pharmaceuticals Research of Equity Research Michael Richard Leacock MainFirst Bank AG, Research Division - Director Richard Vosser JP Morgan Chase & Co, Research Division - Senior Analyst PRESENTATION Operator Good morning, and welcome to the Novartis analyst conference call. (Operator Instructions) And the conference is being recorded. (Operator Instructions) A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends. (Operator Instructions) With that, I would like to hand over to Mr. Samir Shah, Global Head of Investor Relations. Please go ahead, sir. Samir Shah - Novartis AG - Global Head IR Thank you very much, and good morning, everybody, and welcome to our analyst and investor call. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Please refer to the company's Form 20-F on file with the U.S. Securities and Exchange Commission for a description of some of these factors. I also want to point out some important information about the planned tender offer. The planned tender offer dismissed today has not yet commenced and our communication is not an offer or solicitation of an offer to purchase any AveXis' securities. On the commencement date of the tender offer, Novartis will file with the U.S. SEC a tender offer statement on schedule together with other materials and AveXis will file a recommendation statement on schedule 14D-9. We urge you to read these materials that contain important information when they become available. And with that, I'll now hand over to Vas Narasimhan, CEO, Novartis. Vasant Narasimhan - Novartis AG - CEO Thank you, Samir, and thank you all for joining today's conference call. We're very excited about the proposed acquisition of AveXis. If you could turn to Slide 3, as I outlined in our Q4 conference call in January, we are on a journey to focus Novartis on an --as a medicines company powered by data and digital. And already this year, we're off to a strong start to realize that goal. In January, we announced the closing of the AAA transaction to strengthen our oncology portfolio as well as a license share agreement with SPARK Therapeutics to market Luxturna outside of the United States as the first gene therapy for an eye disease. Then later in March, we announced the agreement to divest the OTC JV stake with GSK, pending the approval of GSK's shareholders. And today, we announced the agreement to acquire AveXis, which strengthens our neuroscience portfolio and also enables us to build a gene therapy platform. 2 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
Client Id: 77 APRIL 09, 2018 / 6:00AM, NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 Moving to Slide 4. I outlined as well in January, 5 key priorities to shape our future: Being world-class at operational excellence on our launches as well as driving productivity and margin improvement; breakthrough innovation, which is where AveXis will play a critical role as we continue to focus on high-end first-in-class innovation; a pivot to data and digital leadership; continuing to build our trust with the society; and a cultural transformation. The agreement to acquire AveXis is really in line with our vision to deliver transformative innovation to patients. So moving to Slide 5, a little more detail on the strategic rationale for this transaction. First, this is the AVXS-101, the lead molecule --the lead medicine at AveXis is a potentially transformative treatment for SMA. It has the potential to be the first single gene replacement therapy; if approved, and it could save the lives of these children, improve motor function in children with SMA Type 2, and really addresses an area of significant unmet medical need. It also provides us capabilities in gene therapy. We have a robust internal portfolio of gene therapies in ophthalmology and neuroscience in Novartis Institutes for BioMedical Research. And we look forward to using AveXis' capabilities in manufacturing capabilities and technical development capabilities to enable us to advance that portfolio. And finally, it supports our neuroscience strategy and our ability to expand our portfolio of medicines in neuroscience in areas where we have been a leader for over 60 years. Two new programs would enter our portfolio, a gene therapy for Rett Syndrome and a gene therapy for a genetically driven form of ALS, both with the potential to have IND filings later this year. So moving to Slide 6, just a brief overview of AveXis. AveXis is a clinical-stage gene therapy company focused on neurological, rare and life-threatening diseases. It's based in Illinois. I'll go through later on some of the background on AVXS-101 and the impressive array of regulatory notifications they have received, indicating the breakthrough nature of this therapy. And their focus is on an AAV9 technology, scientists at AveXis, including their lead scientists, identified that AAV9 is unique in its ability to address diseases of the central nervous system with a high affinity for central nervous system cells. This enables AAV9 to be, we believe, unique in its ability to address a broad range of neuroscience-related diseases. Now for some of the transaction highlights, I'd like to hand it over to Harry, who'll go through them. Harry? Harry Kirsch - Novartis AG - CFO Thank you, Vas. Good morning, everyone. Thanks for getting up so early with us on this call. Let me just make some brief comments on the financials. As you can see on Slide 7, the consideration is that AveXis' shareholders would get $218 per share in cash. That values the company at about $8.7 billion, fully diluted equity basis. The company has about $0.5 billion cash, so $8.2 billion of enterprise value. Now on financing. We do intend to redeploy the proceeds of the sale of our OTC joint venture stake to fund this acquisition. In terms of the financial benefits, we expect that the acquisition assets will contribute to group sales starting in 2019, and then a significant ramp up as of 2020 on its way to become a multibillion blockbuster peak sales asset. We expect significant accretion to the group core operating income and core EPS as of 2020. In 2018 and 2019, we see a slight dilution in earnings per share and core operating income, mainly to ongoing R&D programs. We estimate this to be around 1% points of core operating income each in 2018 and 2019. We do expect significant returns well in excess of cost of capital. And finally, we expect closing in mid of 2018. And with this, already back to Vas. Vasant Narasimhan - Novartis AG - CEO Thank you, Harry. So what I'd like to do now is walk through some of the natural history of SMA as well as provide some context on the data that AveXis has generated to date. If you move to Slide 8, the natural history of SMA Type 1 is quite severe. 90% of children will not survive until 2 years of life or become ventilator dependent. And when you look at the endpoint-free survival, you can see that there's a rapid deterioration in these children already at 6 months of age and as --once they reach 2 years of age, it's very minimal survival. In addition, most motor milestones that are expected in healthy babies are not met with SMA Type 1. So it is a devastating disease for parents, for families. And so it's one of the leading cause of genetically associated death in infants in the United States and in Europe. So it is a very important disease to address. 3 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
Client Id: 77 APRIL 09, 2018 / 6:00AM, NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 If you move to Slide 9, SMA, as a disease, covers a continuum of different types. We estimate there is currently about 23,500 patients worldwide in established markets. Those --of course, with screening those numbers are variable, and we'll see how they evolve. Type 1 SMA indicates the --a patient has 2 copies of the SMN2 gene. Onset is usually early, before 6 months of age, as I said. And these are the patients, who are over 90%, will die by age 2. In SMA Type 2, again, a very severe form. Patient have 3 copies of the gene. These patients will never be able to walk without support, most will never stand, 32% die before age 25 and most require lifetime support from families as well as the medical --and medical institutions. Type 3 and 4 SMA are less severe. Type 3, in particular, is of note because it could be a future of relevance for these kinds of therapies. The Type 3 SMA has 3 or 4 copies of the gene. Patients can typically stand unassisted and walk independently, but they lose their ability to walk over time. And I think screening, of course, as I said, will increase. Now if you go to Slide 10. We do expect over time that U.S. newborn screening could transform SMA care. You could imagine a world that has therapies like AVXS to become available, there would be newborn screening at birth and then treatment to enable as many neurons to be preserved as possible. And there's clear progress on this at the moment for U.S. federal and state newborn screening. So when you think about how to model a medicine like this, you have the new patients who are incident for the disease, you have the prevalent pool of patients at various age groups who are looking for the best possible treatment to enable a normal life. And then in the future, you have the power of newborn screening to identify as many patients with any SMA --SMN abnormalities in terms of number of gene copies that then you could treat over time. So let me go through a little bit of the mechanism of disease and the therapeutic strategies. Normal individual: There's a primary SMN1 gene that produces this critical protein for neuron function --a motor neuron function and also normal individuals have SMN2 backups, multiple copies of the backup gene. In afflicted individuals, the primary SMN1 gene is not present and patients have variable numbers of the SMN2 backup copies. Now currently, the approved therapeutic strategies are to, in fact, supplement the lack of SMN protein by using various approaches that add SMN protein into the patients over time, but these require chronic treatment because the underlying disease has not been tackled. With gene therapy, AVXS-101, you reintroduce the primary SMN1 gene to enable normal --hopefully, more normal production of the protein, enabling neurons to function appropriately. Moving to Slide 12. AVXS-101, therefore, has the potential to be the first gene replacement therapy for SMA. It consists of an AAV9 capsid shell as well as a self-complementary DNA technology, which was another breakthrough associated with the ability to use AAVs. And the human SMN and 1 transgene, as mentioned, which will enable stable functioning of the SMN gene. Moving to Slide 13. This is the data that was presented last year in the New England Journal of Medicine. On the left-hand inside, you can see the AVXS-101 clinical study results where 100% of patients survived the study period and are --have continued to survive to this day, achieving the vast majority of normal motor milestones, so really a true breakthrough. On the right-hand side, you see data from another available medicine. And you can see the control group, how --typically what you see with these patients as well as our medicines' performance. Important to note, there is a lot of differences in study design, so extremely difficult to make cross-study comparisons depending on the time of treatment and in various endpoints used. But you can see the data here and both datasets are available on --at the New England Journal of Medicine. Now moving to Slide 14. You can see the outstanding performance of the medicine on achieving motor milestones, in particular patients who are treated at 4 months of age or younger achieve all of their major motor milestones and it's largely on track. And this is --as AveXis noted in their Q4 conference call, continues to be the case as they continue to follow-up these patients. Additional long-term data will be presented at AAN on April 25. And AveXis will be releasing that data at the appropriate time. Slide 15. AVXS-101 has an expanded clinical development program. The data we just showed is from CT-101, the first study you see at the top. Ongoing studies include long-term follow-up of the CT-101 study as well as the ongoing STR1VE study. This is an additional study in SMA Type 1 in children less than 8 kilograms with IV dosing. In SMA Type 2, the STRONG study is currently ongoing. This uses intrathecal dosing and single-dose, again, in children who are greater than 8 kilograms and have SMA. Also, planned are presymptomatic SMA Type 1, 2 and 3 to take advantage of the potential of newborn screening, the SPR1NT study as well as an all comers pediatric SMA Type 1, 2, and 3, the REACH study also planned for start later this year. 4 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 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Client Id: 77 APRIL 09, 2018 / 6:00AM, NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 So moving to Slide 16. After a regulatory update in the U.S., the medicine was granted Breakthrough Therapy Designation and with the approval to initiate additional studies. A pre-BLA meeting is planned for Q2 of this year and a BLA submission is planned for the second half of 2018. In the EU, the medicine has received PRIME designation, which is also similar to Breakthrough Therapy Designation. Scientific advise has also been received and the file submission in Europe is planned for the second half of 2019. And finally, in Japan, the medicine achieved a Sakigake designation, which is a designation that indicates, again, a breakthrough therapy in the Japanese context. Pre-submission discussions for the medicine are planned in Q3 of 2018. So Slide 17. One of the other things we were very impressed by was AveXis' significant progress in manufacturing capabilities. They have a impressive facility in Libertyville, Illinois, and they're planning additional facilities for capacity build out. They have manufactured clinical supply, they have executed process validation, they're building commercial launch inventory and they're preparing for their BLA submission and pre-license inspection. We view this as well as an important capability to add to Novartis as we continue to build out our own portfolio of AAV-based therapies. So moving to Slide 18, and building on that point, we believe AveXis offers an attractive gene therapy platform for us. In addition to AveXis' internal programs, which I'll say a word about, we have programs in hearing loss with an AAV5, that's in Phase Ib. Another program in retinitis pigmentosa with an AAV8 also in Phase Ib as well as a range of additional programs through our Homology Medicines collaborations and other collaborations that all take --enable --all require the ability to produce AAVs. So having this manufacturing capacity and expertise, we believe will help us accelerate our entire portfolio of gene therapies in our core therapeutic areas of neuroscience, ophthalmology and oncology. So moving to Slide 19. AveXis also plans to advance 2 new gene therapy products into the clinic in late 2018. AVXS-201 is for Rett Syndrome, this is a rare neuro-developmental genetic disorder. It's caused by an X-linked dominant mutation for CPG with a median age of diagnosis, again, in childhood of 2.7 years. They're well on their way to getting the IND filed for this medicine. As well as AVXS-301 for genetic ALS with a certain mutation type as well. This --of course, as you all know, ALS is a debilitating disease that impacts patients as they progress in life, and just another exciting opportunity. As I mentioned both medicines, the plan is to submit IND applications in late 2018 and early 2019. So closing on Slide 20, our expected next steps. There'll be long-term data for AVXS-101 at the AAN on April 25. The pre-BLA meeting is planned for Q2 2018 with the file submission in the second half of '18. EU file submission, as I mentioned, in the second half of 2019 and the ongoing recruitment of the clinical development programs. As Harry mentioned, Novartis --and Samir as well, is to commence a tender offer for the outstanding shares of common stock of AveXis. We expect closing in mid 2018, subject to success of the tender offer and satisfaction of customary closing conditions. So with that, I will hand it back to the operator and ask for questions. Thank you. QUESTIONS AND ANSWERS Operator (Operator Instructions) And we will take our first question from Richard Vosser with JPMorgan. Richard Vosser - JP Morgan Chase & Co, Research Division - Senior Analyst A few please. Just thinking about the screening program, just thinking about potential costs to health care systems and how do you see it working? Would you think about all newborn babies being tested? Just trying to get at sort of how easy is it to identify these patients today? How easy was it to recruit the clinical trials? You've given us the --second question, you've given us the prevalent population, but the incident population would be useful, if you could give us those numbers as well. Is it for Type --for both Type 1 and Type 2? Are we looking at about 1,000 to 1,500 U.S. or --sorry, those --the geographies you've said for the incident population for Type 1? And then finally, just thinking about your M&A strategy, previously we've been looking at both on this $2 billion to $5 billion, clearly this is a decisive move slightly above that range and a strategic move. Could you just talk about some updated thoughts on the M&A strategy? 5 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. 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Client Id: 77 APRIL 09, 2018 / 6:00AM, NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 Vasant Narasimhan - Novartis AG - CEO Thanks, Richard. In terms of screening programs, this is --this would be a part of routine screening. There's no major or additional costs that we're aware of that are associated with the screening. I mean, this is readily identifiable ones implemented as part of newborn screening, which is normal, of course, in the United States to screen for genetic illnesses. So we do expect over time, especially with therapies now available for newborn screening to be put in place. Our overall strategy for the medicine is to initially launch in SMA Type 1 under 8 kilograms, potentially a broader indication as well pending the discussions with the FDA, expand into greater M&A programs for the older kids who have SMA Type 2, get the indications for newborn screening, which would then enable the medicines to be used for all children who are identified in the U.S., and hopefully, Europe over time. In terms of the epidemiology, I'll hand it over to my colleague, Janneke van der Kamp, who's our Global Head of Marketing for pharmaceuticals. Janneke? Janneke van der Kamp Thank you, Vas. So your question on the incident population. The incidence rate between 1 in 6,000 and 1 in 10,000 newborns. Those are the data coming from the SMA Foundation. So indeed, like Vas said, there is, of course, 1 population that we expect to be treating and then indeed in the established markets, we have the preference population of 23,000 patients. So that's people living with SMA today, and we also expect to treat many of those. Maybe to add 1 point to your question around cost. Of course, you asked about the cost of the screening, but maybe another important point to note around cost is that in the U.S. if we look at patients that are diagnosed relatively early with SMA, the median cost to the system is around $150,000 per year per patient. So that's what's the --an SMA patient's cost today to the system and that's excluding medication cost. Vasant Narasimhan - Novartis AG - CEO Great. Thank you, Janneke. And then, Richard, lastly on M&A strategy. As we said, our goal is to continue to build on our core medicines --as a medicines company powered by data and digital. With the exit of the GSK stake, our intention was to redeploy the capital into our core --in its core therapeutic areas and to build new technology platforms. A deal like this sits right in that sweet spot. It builds our neuroscience pipeline as well as gives us a new capability in gene therapies, which then we can use to expand in our other core therapeutic areas. Looking ahead, we'll continue to look at opportunities that are value-creating for shareholders and the company as well as patients in this kind of bolt-on category. So we'll continue to assess opportunities as they arise, and of course, keep you all informed. Operator We take our next question from Matthew Weston with Crédit Suisse. Matthew Weston - Crédit Suisse AG, Research Division - MD and Co-Head of European Pharmaceutical Equity Research Three questions, if I can, Vas. The first is on the revenue ramp. So Janneke has kindly given us the cost per patient, but obviously, with gene therapy, one of the things that all governments and funding bodies are going to have to come to terms with is, is how to reimburse potentially a one-time treatment that leads to a cure. Now I'm not asking for your pricing strategy, but I'm sure in doing the due diligence for the deal you've thought about the revenue ramp of the product. Looking at consensus, AveXis numbers that seems to be an immediate jump basically to $1 billion of revenue on launch of 101. And I wondered whether or not you are prepared to comment on whether or not you thought that was a reasonable move or whether or not you expected that we needed to think of a more phased revenue ramp as we enter an entire new technology? Secondly, around --following on from Rich's question around M&A strategy. I know you've pitched this as a neuroscience deal, but really it's a move, as we see it, into rare disease. Do you want to comment as to whether or not you see a broader move into rare diseases or whether or not you feel that Novartis' current infrastructure and infrastructure you can build organically is more than enough for you to satisfy your strategic goals? And then the final question is around manufacturing logistics and data. Often times when we see a large cap pharma acquire biotech companies, we see 6 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
Client Id: 77 APRIL 09, 2018 / 6:00AM, NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 that they have to revisit data whether it would be around manufacturing infrastructure, regulatory requirements, and it's whether in your due diligence, your confidence that in this case you can meet the relatively rapid filing and approval goals that are baked into the market? Vasant Narasimhan - Novartis AG - CEO Thanks, Matthew, I appreciate the questions. First on revenue ramp. What we've guided to in our announcement, there is a significant revenue ramp from 2020 forward. In my view when you look at the situation with SMA, the currently marketed medicine is already reimbursed across the United States by private insurers and by Medicaid as well as almost all major European markets. So in this case, given the severity of this disease and the desire to help these patients, payers have already made the decision to invest. And when you look at the amount they're investing over time for the existing medication, it's quite significant already. So we believe, in this case, that decision has already been taken. And I believe over time, the issue here is not payer, payers appreciate that when you deliver a potentially curative therapy that takes out cost out of their health care system and enable people to live, hopefully, a more normal life, they are willing to pay and the key is the value. Our goal will be to take an approach on pricing that's focused on value, so value-based pricing, ensuring we're cost effective, ensuring we have appropriate programs in place to enable access. But again, in this case, we think that the road work has been in --put in place and now we can hopefully with the closure of this deal be able to bring AveXis forward across those markets. In terms of M&A strategy, the way we look at it in certain areas such as neuroscience and ophthalmology, there will be a pivot to rare diseases and gene therapies. We believe the monogenic, genetic disorders, potentially polygenic disorders can be addressed with gene therapies, that's why we made the move with Luxturna to license Luxturna outside the United States for ophthalmology, that's why we made the move here. We believe the science is very profitable, the efficacy is quite significant. So when I think about rare diseases, I try to put it in the lens of, is this in a therapeutic area where we already have a significant presence that we can leverage in both neuroscience, ophthalmology, you can argue with pediatric ALL, and CART, and oncology. These are rare diseases, those diseases that fit into our therapeutic profile. We have a lot of capability in this given our work with Ilaris. Ilaris, of course, is treating CAPS in hereditary periodic fever disorders, has been incredibly successful as well as Sandostatin in some of our rare drugs in oncology. So we have this rare disease capability as well. But I would say, we would assess each opportunity with the lens of, is it a technology that we're interested in? Does it fit in our therapeutic areas to do things and generate value for Novartis patients and our shareholders. And lastly, in terms of manufacturing logistics, we've done a very careful due diligence. We believe the company has done a great job in terms of its work on validating its batches and validating its process, gearing up and being ready for FDA inspection. So we feel comfortable based on all we've seen and where we are. And I think, given our experience in Morris Plains with our CART therapy, we have a pretty good understanding of what it take to get through an FDA inspection for one of these medicines. Operator We take our next question from Michael Leuchten with UBS. Michael Leuchten - UBS Investment Bank, Research Division - Co-Head of Pharmaceuticals Research of Equity Research It's Mike Leuchten from UBS. Two clinical questions, please. One, is your view that the direct administration of the transgene trumps the splicing approach or can you comment on potential combination given you have branaplam in Phase I/II testing in your own pipeline? And then secondly, have you --did you have any view as to whether there is potential for retreatment with the AAV9? And I'm thinking about antibodies here that might deny the ability to do that. Vasant Narasimhan - Novartis AG - CEO Thank you, Michael. In terms of the potential for complementarity, I mean, I think, our view is that this therapy will become the front-line therapy, because of its ability to address the underlying basis of the disease. And then, of course, the patients and parents will have to determine and as well as clinical data --as well as the physicians, most importantly, as well as the clinical data how additional therapies could be used to further augment the patient's overall functioning. We view our current internal oral drug LMI, which is quite early, really it's something that's complementary to this kind of a gene-based approach for patients. The approximate 10% to 15% of patients that have AAV antibodies, alternative therapies are going to be required. And so I think, having something like our LMI molecule will be complementary to what we have here with the gene-based 7 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 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Client Id: 77 APRIL 09, 2018 / 6:00AM, NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 approach. In terms of the retreatment, we don't know how retreatment would work. As I said, we know that there's about 10% to 15% of patients in SMA 1 and 2 that have AAV antibodies. And so those patients will need an alternative approach as well as we also know that pregnant mothers can transfer AAV antibodies, so those antibodies have to be cleared out. So there could be roles for other medicines to bridge to the gene therapy. These are all things, I think, that will be worked out over time as we generate more and more data. Operator We take our next question from Michael Leacock with MainFirst. Michael Richard Leacock - MainFirst Bank AG, Research Division - Director I have 3 brief question, if I may. Firstly, on the follow-up compounds, the Rett and the ALS compounds. I understand that they are licensed in to AveXis rather than owned by AveXis. Is that correct? And will your purchase of AveXis make any difference to that ownership? Secondly, I think there was quite about the 1 in 6,000 to 1 in 10,000 children born with SMA. Is that for all types of SMA? And if so, what proportion of those patients or children would be SMA Type 1? And thirdly, given the innovative nature of the product, how long do you think it would be before the Type 2 development could lead to a product in the marketplace? And so how long would it take for you to get approval for Type 2 following a Type 1 approval? Vasant Narasimhan - Novartis AG - CEO So thanks for the question. On the first question on the licensing into the 2 molecules, I'll hand it over to our Global Head of M&A, Nigel Sheail. Nigel? Nigel Sheail Yes, it's correct that the programs are licensed in, but AveXis have the rights to those programs. I think that's actually also true of AveXis 101. And in our modeling and financial assessment, we've included the relevant costs of royalties and other associated payments with those licenses. Vasant Narasimhan - Novartis AG - CEO Thanks, Nigel. And on the incidence on the split between SMA 1 and 2, I don't know, Janneke, if you have that information handy. Janneke van der Kamp Sure, Vas. That is actually on Slide 9 of the presentation. If you --there's lot of numbers on it, of course, but you can see there in the road assess, incidence split, that's off that incidence number that I just mentioned, about 60% is SMA 1, 27% SMA 2 and 13% SMA 3. Now with the advance of newborn screening, as Vas mentioned, in the U.S., we, of course, expect that there could be growth in that diagnosed rate early --for early patients coming from the Type 2 and Type 3 pool. Vasant Narasimhan - Novartis AG - CEO So --and the last question Michael on SMA Type 2. So the initial filing will be in patients under 8 kilograms, so that's roughly 6 months of age with an IV formulation that's what the clinical trials to date have indicated. There is an ongoing study with single intrathecal, so into the spinal cord administration and that in patients greater than 8 kilograms covering patients regardless of --again, of the SMA type. We expect that study to enable a filing in the 2020 time line. So that's our --how we've currently modeled that coming on board. But we have to, of course, see now, with the discussions with the regulators, how things unfold. 8 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
Client Id: 77 APRIL 09, 2018 / 6:00AM, NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 Operator (Operator Instructions) We will take our next question from Luisa Hector with Exane. Luisa Caroline Hector - Exane BNP Paribas, Research Division - Pharma Research Analyst I just wonder if you could comment any further on the competitive landscape on any of the gene therapy approaches that you're aware of? And then secondly, could you tell us how long the manufacturing process is and whether there's any particularly unusual steps within it? And the final question would be, given the dilution that you now faced your earnings from the consumer exit and a small amount from this AveXis acquisition midterm, will you be doing any incremental buyback to offset that? Vasant Narasimhan - Novartis AG - CEO So thanks for the question. On the competitive landscape, there are, to my knowledge, a few preclinical gene therapies that I think it's too soon to comment on where those gene therapies are and how they might progress. So I think, we'll, of course, keep you updated as we understand the competitive landscape better. In terms of the manufacturing process, I don't know the answer to that of the top of my head, and I'll maybe just ask Nigel. Nigel, do you know by chance the detail of the timing of the manufacturing? Nigel Sheail Sorry, could you repeat the question, I didn't catch the details. Vasant Narasimhan - Novartis AG - CEO The question is what is the --how long does it take to complete the manufacturing process and are there any challenging steps that might be worth noting? Nigel Sheail Yes. So I think the manufacturing process takes about a month from start to finish. There are no critical steps in that process. The LIBERTY fill facility is already been established and is currently running at full capacity and has produced several batches on a very consistent and high-quality basis. There were also... Vasant Narasimhan - Novartis AG - CEO (inaudible) Nigel Sheail As you can say, we --there were also plans to build a second facility, which will further increase capacity. Vasant Narasimhan - Novartis AG - CEO Thanks, Nigel. On the topic of dilution, Harry, do you want to take that? 9 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
Client Id: 77 APRIL 09, 2018 / 6:00AM, NOVN.VX - Novartis AG Acquisition of AveXis Inc - Investor Call 1 Harry Kirsch - Novartis AG - CFO I think --thank you, Luisa. The question was on share buybacks. Now share buybacks will continue to be part of our capital allocation priorities. As you know, first probably being invest in organic business opportunities; the second being a strong and growing dividend of Swiss franc; third being bolt-on acquisitions like this one, for example; And fourth being share buybacks. Now we have not announced an additional share buyback program yet, we expect share buybacks to be continuously part of the mix. But we would basically announce it separately, if it would become, again, part of our capital allocation priority in the near term. And we have an ongoing commitment to always mitigate any dilution from employee participation programs. We don't announce that, we just do that. So there's no dilution from that. But if we would enter another share buyback program to reduce the number of outstanding shares, we would do stand alone or we would do an announcement. Operator It appears we have no further questions at this time. And I would like to hand the call back over to you for any additional or closing remarks. Vasant Narasimhan - Novartis AG - CEO So thank you all, again. I think you can see this is part on target in our strategy of building a focused medicines company as well as on target in our strategy in terms of our desire to bring breakthrough first-in-class medicines in our core therapeutic areas fits with our capital allocation priorities as we've laid them out. So we look forward to keeping you up to date on the progress of the transaction as we move to closing and as well on the progress of AVXS-101 as well as our full pipeline of gene therapies. Thank you all for joining the call. Operator Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect. 10 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. DISCLAIMER Thomson Reuters reserves the right to make changes to documents, content, or other information on this web site without obligation to notify any person of such changes. In the conference calls upon which Event Transcripts are based, companies may make projections or other forward-looking statements regarding a variety of items. Such forward-looking statements are based upon current expectations and involve risks and uncertainties. Actual results may differ materially from those stated in any forward-looking statement based on a number of important factors and risks, which are more specifically identified in the companies' most recent SEC filings. Although the companies may indicate and believe that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate or incorrect and, therefore, there can be no assurance that the results contemplated in the forward-looking statements will be realized. THE INFORMATION CONTAINED IN EVENT TRANSCRIPTS IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE CONFERENCE CALLS. IN NO WAY DOES THOMSON REUTERS OR THE APPLICABLE COMPANY ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY EVENT TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S CONFERENCE CALL ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS. ©2018, Thomson Reuters. All Rights Reserved.
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In connection with the proposed acquisition, Novartis and an indirect wholly-owned subsidiary of Novartis (Purchaser) will commence a tender offer for the outstanding shares of common stock of Avexis, Inc. (the Company). This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities. The tender offer for the shares of common stock of the Company has not commenced. At the time the tender offer is commenced, Novartis and Purchaser will file, or will cause to be filed, a Schedule TO Tender Offer Statement with the U.S. Securities and Exchange Commission (the SEC) and the Company will file a Schedule 14D-9 Solicitation/Recommendation Statement with the SEC, in each case with respect to the tender offer. The Schedule TO Tender Offer Statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the Schedule 14D-9 Solicitation/Recommendation Statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials and all other documents filed by, or caused to be filed by, Novartis and Purchaser and the Company with the SEC will be available at no charge on the SECs website at www.sec.gov. The Schedule TO Tender Offer Statement and related materials also may be obtained for free under the InvestorsFinancial Data section of Novartis website at https://www.novartis.com/investors/financial-data/sec-filings. The Schedule 14D-9 Solicitation/Recommendation Statement and such other documents also may be obtained for free from the Company under the Investor + Media section of the Companys website at http://investors.avexis.com/phoenix.zhtml?c=254285&p=irol-IRHome.
Exhibit (a)(5)(E)
THOMSON REUTERS STREETEVENTS EDITED TRANSCRIPT AVXS - AveXis, Inc., Novartis AG - M&A Call EVENT DATE/TIME: APRIL 09, 2018 / 4:00PM GMT THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
APRIL 09, 2018 / 4:00PM, AVXS - AveXis, Inc., Novartis AG - M&A Call CORPORATE PARTICIPANTS Dan Bar-Zohar Harry Kirsch Novartis AG - CFO Nigel Sheail Samir Shah Novartis AG - Global Head IR Vasant Narasimhan Novartis AG - CEO CONFERENCE CALL PARTICIPANTS Gena Wang Barclays Bank PLC, Research Division - Research Analyst Matthew Weston Crédit Suisse AG, Research Division - MD and Co-Head of European Pharmaceutical Equity Research Michael Leuchten UBS Investment Bank, Research Division - Co-Head of Pharmaceuticals Research of Equity Research Stephen Michael Scala Cowen and Company, LLC, Research Division - MD and Senior Research Analyst PRESENTATION Operator Good morning, and welcome to the Novartis conference call. (Operator Instructions) And the conference is being recorded. (Operator Instructions) A recording of the conference call, including the Q&A session will be available on our website shortly after the call ends. (Operator Instructions) With that, I would like to hand the call over to Mr. Samir Shah, Global Head of Investor Relations. Please go ahead, sir. Samir Shah - Novartis AG - Global Head IR Thank you very much, and good afternoon, everybody. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Please refer to the company's Form 20-F on file with the U.S. Securities and Exchange Commission for a description of some of these factors. It's also important to point out some information about the planned tender offer. The planned tender offer discussed today will have not yet commenced and our communication is not an offer or solicitation of an offer to purchase any of AveXis securities. On the commencement date of the tender offer, Novartis will file with the U.S. SEC a tender offer statement on schedule TO, together with other materials and AveXis will file a recommendation statement schedule 14D-9. We urge you to read these materials that contain important information when they become available. With that, I'll now hand the cross to Vas Narasimhan, CEO of Novartis. Vasant Narasimhan - Novartis AG - CEO Thank you, Samir, and thanks, everyone, for joining today's call. We are very excited about our proposed acquisition of AveXis, which we believe fits with our core strategy of building our presence in innovative medicines, building --bringing forward breakthrough medicines that are first-in-class, strengthening our neuroscience pipeline and becoming a leader in gene therapy. If you go to Slide 3, you can see that what we said in the Q4 conference call is we want to be a focused medicines company powered by data and digital technologies. And this deal along with other recent deals really shows that we're on a track to get there. In January, we announced the acquisition of AAA to strengthen our oncology portfolio as well as a licensing agreement with SPARK for Luxturna, the first gene therapy for retinitis 2 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
APRIL 09, 2018 / 4:00PM, AVXS - AveXis, Inc., Novartis AG - M&A Call --a subtype of retinitis pigmentosa. We also in March announced our agreement pending GSK shareholder approval to divest the OTC JV stake. And then today, we've announced our agreement to acquire AveXis. Now moving to Slide 4. I --also in the Q4 conference call, I described 5 key priorities to shape our future as a company. And one of those was focused on breakthrough innovation that we want to pivot more whenever possible to first-in-class medicines that are transformative in efficacy, that we can build powerful value proposition to payers, patients and society. And we believe that AveXis is fully in line with our Novartis vision to deliver this transformative innovation in areas of high unmet medical needs. So moving on to Slide 5. The strategic rationale for Novartis to do this deal that expands our leadership both in gene therapy and in neuroscience. First, we believe AVXS-101 is potentially a transformative treatment for SMA, and I'll talk more about that in subsequent slides. Second, this acquisition provides capabilities in gene therapy, both related to the AAV9 platform, but also broadly in gene therapy manufacturing and technical expertise that will allow us to advance our internal portfolio of gene therapy assets. And then finally, it supports our neuroscience strategy with the possibility of additional therapies for Rett Syndrome and ALS amongst others that we can build off of this platform. On Slide 6, just a brief overview of AveXis. AveXis is a clinical-stage company that's based in Illinois. They got a range of great milestones already achieved on AVXS-101, and their gene therapy pipeline is broad, as I just described across 3 different molecules. Now going to Slide 7, I'll hand it over to Harry to go through some of the transaction highlights. Harry Kirsch - Novartis AG - CFO Yes. Thank you, Vas, and good morning, good afternoon, everybody. Let me just make some brief comments on the financials. And as you see the consideration, and as you have seen in the press release, is the agreed acquisition price of $218 per share. This values AveXis at approximately $8.7 billion equity value. The company is roughly $0.5 billion cash. So $8.2 billion enterprise value. In terms of financing. We intend to redeploy the proceeds we expect from the OTC joint venture stake sale to fund this acquisition. And in terms of the financial benefits, we expect that the acquisition contributes to group sales in 2019, and shows a significant ramp up as of 2020 on its way to a multibillion blockbuster peak sales. We also expect significantly accretive to core group OpInc and core EPS from 2020 to the group results. And we do expect a slight dilution in EPS in 2018 and 2019 and to core operating income, mainly from ongoing R&D investments. And this is in the range of about 1% point of core operating income in each year. Now the returns we expect to be significantly in excess of our cost of capital. We do expect the closing in the mid of 2018. And with that, I hand back to Vas. Vasant Narasimhan - Novartis AG - CEO Thank you, Harry. So moving to Slide 8. I would like to walk you through some of the details surrounding SMA. So first on the natural history of SMA Type 1. 90% of these children will not survive until 2 years of age or become a ventilator dependent. And so when you look at the endpoint free survival on the natural history curve at the bottom left of the slide, you can see the rapid deteriorations that most of these patients face within 6 months of age, then 12 months of age, and then you can see the 92% of these patients have died by 24 months or by 20 months of age. In addition, these patients typically fail to meet most normal motor milestones that you can see here, a normal development. This in part informs the clinical trial endpoints that we use for SMA Type 1. Now moving to Slide 9. SMA is an area of significant unmet need affecting about, we estimate 23,500 patients worldwide today, the prevalent population that's out there today. There are 4 types of SMA. Type 1, in which patients have 2 of the SMN2 copy number, have onset in early infancy. They represent about 60% of the incidents, the global incidents and about 14% of the global prevalence. There's about 3,300 of these patients today. And as I said, over 90% die or has a significant critical event by age 2. 3 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
APRIL 09, 2018 / 4:00PM, AVXS - AveXis, Inc., Novartis AG - M&A Call In Type 2, they have 3 copies of the SMN2 copy number, and as you can see the statistics follow with respect to incidence split, prevalence split and the estimated worldwide population. 32% of these patients die before age 25, and most will never stand without support. Type 3 is a later onset type of SMA, primarily because there is additional copy numbers in the genome. And you can here see the numbers as well. These patients can stand unassisted but may lose their ability to walk over time. And then finally, Type 4 usually occurs much later on in life, and there is very little we know about Type 4. It's not been studied well, primarily because there's been no treatments available. So when you move to Slide 10, one of the elements we believe that will happen over time as the prevalent patients are treated by AVXS-101, when approved and then as care continues to improve, that there will be U.S. newborn screening in place to transform the care of SMA. You can imagine a world where newborns are screened, a number --a copy number is then determined and then a decision to provide gene therapy can be made at that point in time to enable as many neurons as possible to be preserved and as normal a life as possible for these children to be obtained. So this is something that is already in progress. There's progress in both U.S. federal and state newborn screening. And we know that in the European Union and other countries are also evaluating the potential for newborn screening. So moving to Slide 11. There's an important element of the mechanism of disease to understand. In a normal individual, we need SMN proteins to support our neural development. SMN1 is the primary gene where the SMN protein is produced. And then from an evolutionary standpoint, we've developed a series of backup genes that then enable SMN2 to ensure that we have adequate SMN production. Now in SMA-affected individual, the SMN1 primary gene is lost. And then depending on the number of SMN2 backup genes they have, the clinical course is determined per the earlier slide I showed. Now there's 2 therapeutic strategies to address this. The first is splicing modulators, and some of the existing therapies where the amount of SMN protein is supplemented by a therapeutic that's given either daily or quarterly to try to ensure adequate SMN protein is available. With gene therapy with AVXS-101, we reintroduce the SMN1 primary genes to affect the underlying cause of disease and hopefully enable functional --adequate amount of functional SMN protein to enable individuals to have a normal neurological development. When you move to Slide 12, you can see the structure of the AVXS-101. It is a recombinant AAV9. AAV9 was identified by the scientists at AveXis as having a particularly strong potential for neurological illnesses and a strong affinity for cells in the central nervous and peripheral nervous system. It also have the self complementary DNA technology, which enables the rapid onset of effect, something you want in these patients. And then you can see the other elements of the medicine, both the continuous promoter as well as a SMN1 transgene. Now moving to Slide 13. This is a clinical trial results that we reported in the New England Journal of Medicine. As you can see, with AVXS-101 out to 2 years of follow-up, there was no events, no deaths and no events and the probability of end-free survival was 100%. It's important to note that all of these patients did not receive any of the approved therapies throughout the course of the study and through the follow-up. We do understand that some of the parents in this clinical trial elected to have additional of the license therapy provided just to ensure their child has the best chance of having a normal life. That was the parent decision, but to the knowledge of AveXis, there was no decline in efficacy at that point in time when that therapy was administered. You can see the approved products data on the right-hand side of the slide as well as the differences we have in study design at the bottom. You can see that there were some differences in end points as well as the mean age of the patients in the trial. Nonetheless, I think the data is incredibly compelling and is something that we're very impressed and excited about and look forward to continuing to see further follow-up data published over the course of this year. So on Slide 14, you can see the results from the motor milestone achievement. Patients who has received AVXS-101 from 4 months of age or earlier met nearly all of their milestones, in most cases all the milestones were met. Patients who received it later on in life, particularly you can see for patient 8, because there were less neurons available to save. You can see that not all of the milestones were met, but survival continuous. And so again, a stunning result with this therapy. So on Slide 15, AveXis continues a broad development program at this time along with AVXS-101, the first trial. Now the CT-101 trial, there is now ongoing this --the long-term follow-up of those patients. The STR1VE study, which also is now ongoing, a confirmatory study as well as the STR1VE EU study as well. In SMA2, the STRONG study is currently enrolling to look at the effect of the medicine in SMA Type 2. We have the SPR1NT study ongoing. Our plan to start later this quarter that will tackle looking at presymptomatic SMA treatment to really take advantage of the newborn screening approach. And finally, an All Comers study as well. 4 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
APRIL 09, 2018 / 4:00PM, AVXS - AveXis, Inc., Novartis AG - M&A Call From a regulatory standpoint on Slide 16, in the U.S. Breakthrough Therapy, designation has been granted. A pre-BLA meeting is planned for the Q2 2018 and the BLA submission planned for the second half of 2018. In EU, the medicine has received PRIME designation, scientific advice is completed and there is a file submission in the second half of 2019. And finally, in Japan, the medicine has received Sakigake designation as a true breakthrough and pre-submission discussions are planned for later this year. Going to Slide 17. AveXis has made a really significant progress in advancing its manufacturing capabilities. Our teams were impressed with the quality of the site. The complete build-out is complete and there is actively batch is being produced in preparation for a launch. And also there is additional facility --additional facility planned to increase and ensure there's adequate capacity for the launch. They're preparing for a BLA submission and pre-license inspection. Our due diligence teams have very carefully looked at this and given our experience in Morris Plains, we're confident with the profile of the manufacturing facility at AveXis. Now on Slide 18, another important element of doing this deal was the ability to build a gene therapy platform at Novartis. We have an internal pipeline of assets in hearing loss, using AAV5, CPK850 in retinitis pigmentosa using AAV8 as well as a series of other medicines that we're developing through Homology Medicines collaboration, in addition to the 2 additional programs AveXis would bring. Having a full scale manufacturing capacity to be able to advance these programs, having technical development and manufacturing know-how, will enable us to accelerate these programs, and we believe build a broad portfolio of gene therapies in ophthalmology and in neuroscience, 2 areas where we believe there is a lot of potential to address monogenic diseases using gene therapy. So we're quite excited about the potential to accelerate our internal pipeline with this acquisition. On Slide 19, AveXis as part of building that pipeline brings 2 additional medicines forward. One is AVXS-201 for Rett Syndrome. This is a --this project should be ready for a submission of IND in late 2018 or early 2019 and then AVXS-301 in a genetic form of amyotrophic lateral sclerosis or ALS, which is also on track for IND submission later this year or early 2019. So we expect both of these programs to also be able to enter the clinic in 2019. So on Slide 20, in closing, we're extremely excited about this transaction. Long-term data will be presented at AAN on April 25. The pre-BLA meeting and file submission is on track. The EU file submission is planned, the recruitment of the additional pivotal study is ongoing. And as Harry mentioned, we've commenced --we will commence a tender offer for the outstanding shares of common stock. And we expect closing in mid of 2018. So with that, I will hand it back to the operator, and turn it over for questions. QUESTIONS AND ANSWERS Operator (Operator Instructions) We'll take our first question from Matt Weston with Crédit Suisse. Matthew Weston - Crédit Suisse AG, Research Division - MD and Co-Head of European Pharmaceutical Equity Research Two questions, if I can. One that we've had recurring this morning is, have you actually seen the data as part of your due diligence that will be presented in April at AAN? And then secondly, regarding unexpected events. I know the deal terms have not yet been disclosed, but are you prepared to comment as to what would happen to your offer in the interim period if there were to be an unexpected event in one of the clinical trials that questions the safety potential of the product? And then finally, pushing my luck at third one, another question that we've had on a recurring basis this morning is whether or not this was a competitive process and you feel therefore that you've secured this asset but whether or not this was an individual approach by Novartis, and therefore there are opportunities for overbidders if other people felt that AveXis asset was attractive? 5 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
APRIL 09, 2018 / 4:00PM, AVXS - AveXis, Inc., Novartis AG - M&A Call Vasant Narasimhan - Novartis AG - CEO So thanks for the questions, Matt, and good to hear you again on the call. Yes, we have seen the data for AAN and feel comfortable with the data. On unexpected events and the competitive process, I will hand it to our Global Head of M&A, Nigel Sheail. Nigel? Nigel Sheail So with regard to unexpected events, we do not have an out, if there is an event on this opportunity. We have obviously completed a thorough due diligence during the process, and as a result of the commercial negotiations, we've come to that agreement on risk sharing. And the second question. Yes, it's normal practice for us. We don't comment on the nature of our M&A processes. Obviously, the background to the transaction will be published in due course as part of the regular filings. Operator We'll go next to Steve Scala with Cowen. Stephen Michael Scala - Cowen and Company, LLC, Research Division - MD and Senior Research Analyst I have 3 questions. First, what is the status of the additional capacity to support the launch? Second, is there a potential for combination therapy? Or do you see AVXS-101 being used alone? And then lastly, I could be wrong and maybe this is going to answer Matthew's question, Vas. On Page 13, I thought you said, the data out to 2 years, the graph is out to 1 year. And I thought you said, out to 2 years was 100% survival, that's the data that's coming later this month, so perhaps you can clarify? Vasant Narasimhan - Novartis AG - CEO Yes, thank you, Steve. So on the additional capacity, they have adequate --AveXis has adequate capacity in their Libertyville facility. And in addition, they have plans to build an additional facility, but that won't be required for a launch capacity. We feel comfortable with their capacity that they have. With respect to combination therapy, we believe that AVXS-101 will become the front-line therapy for all patients diagnosed with SMA in which patients have a desire to be treated. They're, of course, given the mechanism, the mechanisms could be complementary to also supplement with, I think, exogenous sources or of other methods of promoting SMN protein production. So certainly there is a potential for combination therapy if physician or patient will ultimately decide that's needed or desirable. And then lastly, on the data point, I'm going to turn it over to Danny Bar-Zohar, our Head of Neuroscience, just to be sure I say something completely accurate. So Danny? Dan Bar-Zohar Yes. No, no, you said it very accurately, Vas, and it's 2 years data, 100% event-free. The data point, it's Slide #13, if it was. It's up to 78 weeks. It's the first primary analysis, but I confirm that this is for 2 years. Vasant Narasimhan - Novartis AG - CEO Next question, operator? Operator And we'll go next to Michael Leuchten with UBS. 6 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
APRIL 09, 2018 / 4:00PM, AVXS - AveXis, Inc., Novartis AG - M&A Call Michael Leuchten - UBS Investment Bank, Research Division - Co-Head of Pharmaceuticals Research of Equity Research Michael Leuchten at UBS. Two questions, please. One, Vas, you mentioned that a number of (inaudible) 15 patients went on to other therapies. I just wondered if you're able to quantify how many patients actually did go on to receiving splicing therapy? And then, what --if that's the way it goes, what that may or may not mean from a pricing perspective given that you think it's going to be transgene that goes first line, but then possibly maintenance therapy somewhere else? And then adverse events, there was a publication in Nature earlier in the year talking about potential liver toxicity with devecta. Just wondering what amount of due diligence you were able to do given the limited number of patients in the study? Vasant Narasimhan - Novartis AG - CEO Yes. Thank you for the questions, Michael. First, on the patients. I know this has been a topic on patients receiving the splicing therapy. Patients were actual completing the study at their option, of course, to do what they thought was best. To our understanding, there was no change in the clinical situation of any of the patients in the study. Certain parents opted to have additional therapy because they wanted the best for their child. I don't think it's been disclosed publicly the number of patients who were in different cohorts, but that will be part of the data that's presented at AAN, where I think there will be better clarity on the performance of the medicine in patients who received no other therapy over time. In terms of the impact on pricing, again, we view this as a first front-line therapy that can provide a, we hope a definitive treatment for these patients given the --when the gene is in place and if there is adequate motor neurons that the gene should continue to produce adequate protein, we expect over time. So it doesn't impact our pricing strategy. We expect that this medicine to be the lead medicine for these patients. In terms of the adverse events profile, because of the adenovirus profile, there is some reaction in the liver that you do see is transient and it fully resolves on steroids. These patients had a transient liver enzyme elevation but then resolved and was not seen again throughout the entire course of the study. So not all patients, some patients had a transient liver enzyme elevation. This has been fully explored by the FDA. We've seen the FDA correspondence regarding this matter and we don't view this as a significant risk. And we feel very comfortable with the safety profile that we've seen thus far in animal studies, in the clinical studies, and importantly, in the correspondence with FDA. Operator And we'll go next to Gena Wang with Barclays. Gena Wang - Barclays Bank PLC, Research Division - Research Analyst Just wondering regarding the timeline closing of around mid-18, what is the assumption behind it? And then, it seems like you incorporate quite a lot of a potential antitrust risk in the timeline. I'm wondering if you can share a little bit more color with us on that? Vasant Narasimhan - Novartis AG - CEO Thank you for the question. Again, I will hand this over to Nigel Sheail, our Global Head of M&A to take these 2 questions. Nigel Sheail So we're very confident of closing in mid-2018. There were basically 2 closing conditions. One is the completion of the antitrust review. And the second one is completion of the tender process. And obviously in line with that, we anticipate that we will complete the antitrust review in time for complete closing in mid-2018. Vasant Narasimhan - Novartis AG - CEO Next question, please? 7 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.
APRIL 09, 2018 / 4:00PM, AVXS - AveXis, Inc., Novartis AG - M&A Call Operator We have no other questions at this time. Vasant Narasimhan - Novartis AG - CEO Okay. I'll make one last call, any further questions from anyone on the line? Okay. So then, Samir, I will hand it back to you. Samir Shah - Novartis AG - Global Head IR Okay. We just want to thank everybody again for listening into the conference call. And with that, I'll say, good afternoon, again. Thank you. Operator That does conclude today's call. We thank you for your participation, you may now disconnect. 8 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2018 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. DISCLAIMER Thomson Reuters reserves the right to make changes to documents, content, or other information on this web site without obligation to notify any person of such changes. In the conference calls upon which Event Transcripts are based, companies may make projections or other forward-looking statements regarding a variety of items. Such forward-looking statements are based upon current expectations and involve risks and uncertainties. Actual results may differ materially from those stated in any forward-looking statement based on a number of important factors and risks, which are more specifically identified in the companies' most recent SEC filings. Although the companies may indicate and believe that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate or incorrect and, therefore, there can be no assurance that the results contemplated in the forward-looking statements will be realized. THE INFORMATION CONTAINED IN EVENT TRANSCRIPTS IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE CONFERENCE CALLS. IN NO WAY DOES THOMSON REUTERS OR THE APPLICABLE COMPANY ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY EVENT TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S CONFERENCE CALL ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS. ©2018, Thomson Reuters. All Rights Reserved.
Legal Disclaimer
In connection with the proposed acquisition, Novartis and an indirect wholly-owned subsidiary of Novartis (Purchaser) will commence a tender offer for the outstanding shares of common stock of Avexis, Inc. (the Company). This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities. The tender offer for the shares of common stock of the Company has not commenced. At the time the tender offer is commenced, Novartis and Purchaser will file, or will cause to be filed, a Schedule TO Tender Offer Statement with the U.S. Securities and Exchange Commission (the SEC) and the Company will file a Schedule 14D-9 Solicitation/Recommendation Statement with the SEC, in each case with respect to the tender offer. The Schedule TO Tender Offer Statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the Schedule 14D-9 Solicitation/Recommendation Statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials and all other documents filed by, or caused to be filed by, Novartis and Purchaser and the Company with the SEC will be available at no charge on the SECs website at www.sec.gov. The Schedule TO Tender Offer Statement and related materials also may be obtained for free under the InvestorsFinancial Data section of Novartis website at https://www.novartis.com/investors/financial-data/sec-filings. The Schedule 14D-9 Solicitation/Recommendation Statement and such other documents also may be obtained for free from the Company under the Investor + Media section of the Companys website at http://investors.avexis.com/phoenix.zhtml?c=254285&p=irol-IRHome.
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