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Let’s pretend we have 300 million shares out fully diluted
Let’s say B is bringing in 1 billion a year.
What is the market cap in regards to traditional Bios?
25 million in cash in bank as well. No other products.
GO!
NOW THIS IS MEAT! EXPECTATIONS!!!$$$$ $600 million to $1.2 billion in first 3 years!
Brilacidin – Competitive Positioning, Market Opportunity for Oral Mucosit
Competitive Positioning
Based on our preliminary estimates, the total Brilacidin oral mucositis market opportunity in Head and Neck Cancer annually in the U.S. and Europe would be approximately $600 million to $1.2 billion.
In follow-up to today’s Press Release, the Company wanted to provide shareholders with additional perspectives on the competitive positioning and market opportunity of Brilacidin oral rinse for use in Head and Neck Cancer (HNC) patients undergoing chemoradiation. Compared to other oral mucositis (OM) drug candidates being evaluated in clinical testing, Innovation Pharmaceuticals believes its drug candidate, Brilacidin oral rinse, occupies a leadership position as preparations move forward for its planned Phase 3 program. Most potential competitor drug candidates target minimizing symptoms and not prevention, and/or are disadvantaged by not having as patient-friendly modes of delivery (IV) in comparison to our easily-administered oral rinse. For detailed comparative analysis, please see our Company blog post on the topic, linked below:
http://www.ipharminc.com/new-blog/2018/9/24/brilacidin-for-oral-mucositis-at-a-glance-comparative-data-presentation-with-other-investigational-om-drugs
Market Opportunity (HNC-Only, US and Europe)
According to published statistics, and based on other data sources, oral mucositis accompanies chemoradiation treatment in almost all Head and Neck Cancer patients undergoing treatment. The annual incidence of HNC in the US and Europe is approximately 150,000 (worldwide approximately 750,000 cases). Approximately 60 to 70% of these patients will develop Severe Oral Mucositis (SOM) (WHO Grade > 3) (confirmed in our own clinical study). Because it cannot be predicted which patients will get SOM, all patients would begin Brilacidin as soon as starting chemoradiation and continue until completion (typically a seven-week course). Given that Brilacidin is administered as a convenient and patient-friendly oral rinse (swish and spit, 3x daily), we believe that our market penetration could realistically approach 80 percent within the first three years following market introduction. This would translate into a targeted 120,000 treated HNC patients in the U.S. and Europe per year according to the anticipated label indication. Moreover, following regulatory approval in HNC, we would anticipate the potential to expand the label to capture a broadened market—patients experiencing OM across various cancer indications, estimated to include as many as 650,000 people annually (25% to 60% of all cancer patients receiving chemotherapy experience OM).
We believe most other competitor products in development, with less patient-friendly modes of delivery (e.g., IV), would be less able to reach this broader OM market. An additional factor that should help to expedite market adoption of Brilacidin oral rinse includes the potential to avoid incremental inpatient costs incurred in those SOM patients requiring hospitalization, estimated to be between $18,000 and $25,000 per incident. Private and government payers would thus be incentivized to adopt preventative treatment due to large potential cost-savings. We anticipate being able to price Brilacidin at $5,000 to $10,000 per full course of treatment based on the large unmet need as well based on initial pricing for the only other OM drug ever approved (Palifermin, hematopoietic stem cell transplantation, HSCT). Based on our preliminary estimates, the total Brilacidin oral rinse market opportunity annually in the U.S. and Europe would be approximately $600 million to $1.2 billion.
For additional insight into the Brilacidin market opportunity for oral mucositis, refer to additional Company blog posts, linked below:
http://www.ipharminc.com/new-blog/2017/10/17/the-market-opportunity-in-oral-mucositis
http://www.ipharminc.com/new-blog/2018/5/4/brilacidin-om-in-the-news-oral-mucositis-market-untappedframed-as-blue-sky-opportunity
http://www.ipharminc.com/new-blog/2017/12/11/brilacidin-om-called-a-top-contender-in-oral-mucositis-market
http://www.ipharminc.com/new-blog/2017/8/7/brilacidin-for-oral-mucositis
http://www.ipharminc.com/new-blog/2017/5/17/on-the-unmet-need-in-oral-mucositis-and-brilacidin-as-a-promising-one-of-a-kind-treatment
I’d still love to know WHAT ARE NEXT STEPS if they plan on using sachets for OM in phase 3? Anyone?
Let’s fire up the program again!!!
Agree. Goal was to get moving in early summer. Still on track if as you believe....everything comes together with protocol and deal.
This also loops in Leo’s comments to Kelt...that the plan is to move forward a program that was put on hold due to financing very soon.
It may all come together soon. IMO.
That’s why we are here
Bravo! Science is key. Manufacturing is key. Both look good and we know the Govt is behind the possibility of this cost saving prevention drug. Let’s get a partner inked and cash in the bank to get back to $4 land
Thx for sharing Leo’s email. I would think money is on its way if they are starting up a program they put to bed due to financing. B-Absssi, eye and ear, IBD, Acne, Kevetrin, etc.....many programs ;)
You said they are going out of business on March 31st.....lol. So Leo and team will meet with EMA IN 3 weeks for no reason at all?
You are all so desperate.
Also that 90 days to meeting after filing does not look to be true. Again so so desperate.
Moving along and strong! Good job ipix.
That would be phenomenal. The goal was to get going in March/April to fire up the trials by early summer.
At this point I’d make a deal with heavier back end milestones for a first time ILL SHOW YOU type of deal. If we have the goods....it will work out and we reap the pay day in the end.
The issue here is that I believe IBD is involved so looking at market deals in that sector we are looking at very big numbers.....that means more time spent crossing Ts and dotting Is to come to a deal. B is just too versatile and complex. IMO.
For all you peeps private messaging me. I’m saying LEO: show us! Don’t tell us, show us. Progress is being made and I can see that but to move Lightspeed ahead he has to show us how we are getting there.
Negotiations are happening in the background but he can’t show us that until a deal is finalized....so we wait and take on uncertainty which easily fuels negativity.
I believe Leo and Art have had a dozen or more conversations with companies they have no interest in....with intentions to better understand the market. IMO. It’s a long game, and after 2-3 years of strong negotiations, I’m hopeful we see a very valuable outcome. We do know, there is major money available.
Im not sure people who have been brain washed here can understand what happens on DEAL DAY.
Everything that they know of and have been told will fly away. All of the screaming there is no hope just vanishes and actually becomes the polar opposite. All of a sudden our pipeline for OM phase 3 looks like a billion dollar blockbuster. The IBD train will be full speed to a 40 plus billion market, Kevetrin Oral May become the first oral frontline cancer therapy for 50% of ALL cancers.
People just can’t see and I don’t blame them. It’s LEOs job to SHOW us.
Same here Wild. I believe in ipix and Leo and I will stick up for my investment. I’d like to hear more from Leo on exact plans but he is stuck lips sealed until this deal closes and they can move all products forward. It’s been a rough couple years but it’s time to get this back into mid dollars - !!!! News tomorrow is always my hope.
Crazy numbers. Lol. Have a great weekend!
I know this number means nothing, but the past weeks in the 70-80’s is interesting. Our time will come, need to move the needle and start some trials. Let’s goIPIX!
Gracias. Much welcomed
So I’m real world discussion: What does this mean for IPIX in regards to market potential? Are they assuming market acceptance and getting ahead by tackling EMA and FDA? Do some companies just stay with FDA and then sell off to BP who then performs trials abroad or gain regulatory acceptance after?
How big is this and what corners are we cutting by doing this now?
Innovation Pharmaceuticals Requesting European Medicines Agency (EMA) Input for International Phase 3 Brilacidin Oral Mucositis Program
Brilacidin
BEVERLY, Mass., March 14, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that necessary documentation has been completed for the European Medicines Agency (EMA) March 15, 2019 submission cycle requesting Scientific Advice to advance Brilacidin oral rinse in a Phase 3 program for the prevention of severe Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation. The documentation is being submitted to the EMA through IPIX Pharma, Ltd., the Innovation Pharmaceuticals Irish subsidiary.
As is customary, the Company is seeking Phase 3 scientific guidance from the EMA regarding the Brilacidin OM program. In December, Innovation Pharmaceuticals completed an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA), during which an acceptable Phase 3 development pathway was agreed upon to advance Brilacidin.
For the Phase 3 program, the Company anticipates international clinical trial enrollment, with participating sites located in the U.S. and in Europe. EMA advice is integral to this plan by helping to ensure that the program meets European standards.
“Our Company is now at an inflection point, emerging as a global leader in new OM therapies. The combination of scientific advice from the FDA and the EMA will leave us well positioned to move forward into Phase 3 development with the goal of Brilacidin becoming the first effective and conveniently administered drug approved by both agencies for decreasing the incidence of OM in HNC patients,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals.
Something smells more like a cat with you and less lemon. I can't put my finger on it. However, everyone has an opinion right.
First I do want to point out: that verbiage is in all filings regarding going concern - first quote. The second with the specific date is a fact. they have stated their plan of operations in the near term and to be honest it is busting at the seam on how much they plan to accomplish. That is what it says.........they need additional funding to support the current "OPERATING PLAN" and they need that financing by end of quarter to move forward with all of these trials they have laid out in PR's over the past 6 months.
Thanks. Looking forward to it!
Where is this countdown coming from?
Cash infusion of over 20 million on top of paid trials and formulation will go a long way. Dollarland is near. We have all seen deals take bios from pennies to multiple dollar land before. I expect to see it here.
Making a ton of cash on a tiny 3+% gain is fortunate. Imagine when a 400 million plus milestone deal hits...multiple times from multiple partners? I would still be in the 10-20 k range of shares if this take down never happened. Thank you for your efforts!
I plan on seeing dollar increases in the future. I’ve seen sub to 20$ plus and I think this stock is that undervalued. Brilacidin is a multi blockbuster drug. Let’s just get 3rd party validation and quit the mofo dilution.
One way or another....this is going to shed the past years of slander. I have been fortunate to accumulate 100’s of thousands of shares over those years all while IPIX science has moved forward to recognize what we hope to be several blockbuster indications. Adding 50-100 million shares to the company OS over 7 years is normal business to pass 7 human trials to get here. ANte up BP’s! We need to spotlight!
Huge Month....an a green one ahead! Love me some Green Beer! It’s the luck of the Irish
Dud - check this article out about IRELAND! Big names love the island!
https://www.siliconrepublic.com/careers/biotech-pharma-companies-ireland
FOMO. It’s paying the bills. Huge spikes recently and going no where, so I think it’s our friends at the FOMO.
Boom time. Laying the foundation to a multi billion bio! Thanks
1 Year for ADVANCED DISCUSSIONS is not long at all. We could be waiting longer honestly...but the fact that OM is placed directly in the GOLD RUSH era, I believe we see something sooner than later as all the check boxes are being checked off and it's time to move fast. IMO.
Again - for all the people that do not understand NEGOTIATIONS and ADVANCED DISCUSSIONS, here is a real life example. FALL OF 2016 Discussions began with 4 BP's and the end result of MERGER occurred in APRIL 2018................ Now imagine with almost 20 CDA's for IPIX how much work could be going into day to day for MGMT! All while running trials and doing all the ADMIN work for patents and international DD, etc.... We know we have met with CEO's and top Scientists........of BP's. This stuff takes time but I have feeling with OM and IBD, it's time to hit pay dirt.
GOOD LUCK REAL INVESTORS!
___________________________________________
https://www.bamsec.com/filing/104746918002890?cik=1652923
Background of the Merger Agreement
The following chronology summarizes the key meetings and events that led to the signing of the Merger Agreement. The following chronology does not purport to catalogue every conversation among the Board or the representatives of AveXis and other parties.
The Company's management and the Board regularly review the Company's performance and prospects in light of its business and developments in the biotechnology and pharmaceutical industries. These reviews have included consideration, from time to time, of potential partnerships, collaborations and other strategic transactions to enhance stockholder value, including potential sale transactions.
In early 2015, prior to the Company's initial public offering, the Company engaged in discussions with Company A regarding a business combination transaction with Company A. After negotiations, the Company and Company A were not able to reach agreement on the terms of a potential combination and Company A terminated discussions. None of the members of Company management at the time of these discussions have a current relationship with the Company.
Beginning in the fall of 2016, following the Company's release of an update on interim data from its ongoing Phase 1 clinical trial of AVXS-101 for the treatment of SMA Type 1, the Company was contacted by several biotechnology and pharmaceutical companies, including Company B, to discuss the Company's business and potential opportunities for various transactions or collaborations. Over the course of the next year, the Company had general discussions from time to time with Company B and other interested biotechnology and pharmaceutical companies.
On June 21, 2017, Mr. Sean P. Nolan, the Company's President and Chief Executive Officer, met over dinner with the Chief Executive Officer and Chief Operating Officer of Company B. At this dinner, the representatives of Company B expressed an interest in submitting an offer to acquire the Company.
On June 29, 2017, the Company received an unsolicited letter from Company B containing a non-binding proposal to acquire 100% of the Company's equity for $112.00 per share, which offer price consisted of 40% cash and 60% Company B common stock (the "June 29 Proposal"). On June 28, 2017, the last trading day prior to the June 29 Proposal, the closing price for shares of the Company's common stock was $81.69.
On July 7, 2017, the Board, along with representatives of Goldman Sachs & Co. LLC ("Goldman Sachs"), which had been engaged as the Company's financial advisor, and Cravath, Swaine & Moore LLP ("Cravath"), which had been engaged as outside counsel to the Company, met to discuss, among other topics, the June 29 Proposal. At the meeting, a representative of Cravath reviewed with the members of the Board their fiduciary duties and obligations in the context of an unsolicited offer to acquire the Company, as well as other legal matters, and representatives of Goldman Sachs discussed with the Board its preliminary financial analyses of the June 29 Proposal. Representatives of the Company's management reviewed with the Board the Company's key upcoming regulatory and clinical milestones relating to the approval and commercial launch of AVXS-101 and the Board considered the risks to the Company of pursuing a transaction during a critical period in the Company's regulatory review process. At this meeting, the Board discussed with the Company's senior management and the representatives of Goldman Sachs the preliminary financial model for the Company prepared by the Company's management, the Company's prospects generally, AVXS-101 and the Company's pipeline. Following discussion, the Board determined to seek improved terms from Company B as a condition to allowing Company B to conduct due diligence or otherwise further exploring a transaction, including,
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among other things, an increase in the offer price, an increase in the cash portion of the consideration and a clear understanding from Company B of the need for closing certainty and the allocation of certain regulatory and clinical risks to Company B at signing.
On July 11, 2017, Mr. Nolan spoke telephonically with representatives of Company B and conveyed the Board's views about the necessary parameters that an offer would be required to include in order for the Board to consider engaging in a transaction with Company B or to permit Company B to conduct due diligence, including an increase in the offer price and agreement in advance on the allocation of regulatory and clinical risks to Company B upon signing of a transaction.
On July 20, 2017, representatives of Company B called Mr. Nolan to deliver a revised proposal to acquire all of the outstanding equity of the Company for $118.00 per share, consisting of $59.00 in cash and a fixed value of $59.00 of Company B common stock (subject to a 10% symmetrical collar), which offer was subsequently delivered to the Company in writing (the "July 20 Proposal"). The July 20 Proposal also stated that Company B was prepared to assume certain clinical and regulatory risks between signing and closing.
On July 21, 2017, the Board, along with representatives of Goldman Sachs and Cravath, met to consider and discuss the July 20 Proposal. The Board determined to seek improved terms from Company B as a condition to permitting Company B to conduct due diligence or otherwise further exploring a transaction. Following the Board meeting, Mr. Nolan spoke telephonically with representatives of Company B and explained that Company B would only be permitted to conduct due diligence if Company B improved its offer, including with respect to price, the consideration mix, the elimination of the collar on the stock portion of the consideration and closing certainty.
On July 24, 2017, Mr. Nolan and representatives of Company B spoke telephonically regarding Company B's perspectives as to how it might improve its offer to acquire the Company. Representatives of Company B emphasized that Company B was prepared to move quickly to execute and consummate a transaction.
On July 25, 2017, Messrs. Nolan and Dee met with representatives of Company B for dinner in Chicago. Company B's CEO stated that Company B would be willing to raise its offer price to $130.00 per share, consisting of 55% cash and 45% Company B common stock, and that the stock portion of the consideration would not be subject to a collar (the "July 25 Proposal").
On July 26, 2017, Mr. Nolan electronically transmitted to representatives of Company B a proposed definition of "material adverse effect" and certain other materials summarizing the Company's position on the allocation of regulatory and clinical risks in a potential transaction and indicated that alignment with Company B on approach with respect to these matters would be necessary in order for the Company to continue discussions with Company B at this stage of the Company's regulatory process. Also on July 26, 2017, the Company received a revised offer letter from Company B confirming the July 25 Proposal in which Company B confirmed that it would agree to bear certain regulatory and clinical risks upon singing of a definitive agreement.
On July 27, 2017, the Board, along with representatives of Goldman Sachs and Cravath, met to consider and discuss the July 25 Proposal. Following the discussion, the Board determined that, in light of Company B's improved offer and indication that it would accept certain key risk allocation and transaction certainty terms, it would permit Company B to conduct limited due diligence to enable it to further improve its offer price as well as to increase the cash portion of the consideration. Following the Board meeting, Mr. Nolan conveyed the Board's decision to a representative of Company B.
On July 28, 2017, Cravath sent a draft confidentiality agreement to Company B's legal counsel, the terms of which were negotiated over the next several days. On July 31, 2017, the Company and Company B executed the confidentiality agreement and the Company provided Company B with access to a virtual data room in order for Company B to perform its due diligence investigation. During the
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following weeks, Company B conducted its due diligence investigation of the Company and representatives of each of the Company and Company B met to discuss certain diligence items.
On August 9, 2017, the Board held a regularly scheduled meeting at which the Company's management reviewed with the Board the status of discussions with Company B. After considering the impact of the due diligence process and transaction discussions on the Company in light of near-term clinical regulatory milestones, the Board determined to request that Company B provide improved terms by the close of business on August 16, 2017.
On August 15, 2017, representatives of Company B informed Mr. Nolan that Company B would be unable to meet the Board's August 16, 2017 deadline for submission of a revised proposal. Following a discussion with the Board, Mr. Nolan spoke telephonically with representatives of Company B and informed them that the Board had agreed to extend the deadline for Company B to submit its final offer to August 23, 2017.
On August 23, 2017, following several weeks of due diligence, in-person meetings and technical discussions, representatives of Company B informed Mr. Nolan that Company B had determined, in light of, among other things, the strong performance of the Company's common stock, the significant premium that would be required to acquire the Company and the stage of development of AVXS-101, to discontinue its exploration of a transaction. Company B's CEO also informed Mr. Nolan that Company B would continue to monitor the Company's performance and would be prepared to reengage following the Company's upcoming meetings with the U.S. Food and Drug Administration (the "FDA").
On September 29, 2017, the Company announced that the FDA had notified the Company that the Company was permitted to initiate its planned pivotal trial of AVXS-101 in spinal muscular atrophy type 1 using the intravenous formulation produced by the Company's commercial manufacturing process.
On December 5, 2017, representatives of the Company met with the FDA for an end-of-Phase 1 meeting, the purpose of which was to review non-clinical, clinical and Chemistry, Manufacturing and Controls (CMC) data that had been generated by the Company, and to align with the FDA on next steps leading to the Company's Biologics License Application ("BLA") submission.
On December 13, 2017, the Company announced that the FDA had notified the Company that the Company was permitted to initiate its planned phase 1 clinical trial of AVXS-101 in spinal muscular atrophy type 2 using the intrathecal route of administration, using material produced by the Company's commercial manufacturing process.
In December 2017, Dr. Charles Bailey, Novartis's Head of Business Development & Licensing, Neuroscience, contacted Mr. R.A. Session II, the Company's Senior Vice President, Corporate Strategy & Business Development, to make an introduction, and invited Mr. Session to meet at the upcoming JP Morgan Healthcare Conference (the "JPM Conference") in January 2018. Although the two were unable to meet at the JPM Conference, a teleconference was arranged for February 2, 2018 with Dr. Bailey and Neil Johnston, Novartis's Global Head of Business Development & Licensing, participating from Novartis and Mr. Session participating from the Company. Mr. Johnston and Dr. Bailey outlined interest in working together with the Company and noted Novartis's commitment to gene therapy as evidenced by the recent licensing transaction with Spark Therapeutics. Mr. Session stated the Company's commitment to its development program. On February 7, 2018, in an email to Mr. Session, Mr. Johnston conveyed the interest of Dr. Vasant Narasimhan, M.D., Chief Executive Officer of Novartis, to speak with Mr. Nolan. Subsequently, a call between Dr. Narasimhan and Mr. Nolan was scheduled for February 16, 2018.
On January 4, 2018, the Company announced alignment with the FDA on next steps toward BLA submission for AVXS-101 following the receipt of minutes from its end-of-Phase 1 meeting with the
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FDA. Following the end-of-Phase 1 meeting and this announcement, the Company received inbound interest from several companies in the biotechnology and pharmaceutical industries regarding a potential strategic transaction with the Company, including Novartis and Company C.
On January 8, 2018, the Company and REGENXBIO Inc. ("REGENXBIO") announced the expansion of their relationship through an amended license agreement for the development and commercialization of treatments for spinal muscular atrophy. The amended license agreement provided for, among other things, the modification of the assignment provision in the parties' original license agreement to permit assignment by the Company without REGENXBIO's consent in the event of a change of control of the Company.
On February 12, 2018, Mr. Nolan and Dr. Brian K. Kaspar, Senior Vice President, Chief Scientific Officer of the Company, met with representatives of Company C over dinner in Rosemont, Illinois, during which the representatives of Company C indicated that Company C had a significant interest in the Company.
On February 13, 2018, the Company engaged Centerview Partners LLC ("Centerview") as a financial advisor to assist the Company to explore potential strategic transactions involving the Company.
On February 16, 2018, Mr. Nolan spoke telephonically with Dr. Narasimhan and Mr. Nigel Sheail, Head of Mergers & Acquisitions and Business Development & Licensing of Novartis. Dr. Narasimhan expressed a strong interest in acquiring the Company and indicated that he had the support of Novartis's chairman to submit a proposal to acquire the Company for $190.00 per share in cash. Mr. Nolan emphasized the Company's intent to continue its focus on its business as a stand-alone company given its upcoming regulatory and clinical milestones but stated that he would provide any proposal made by Novartis to the Board for consideration.
On February 19, 2018, the Company received an offer letter from Novartis containing a preliminary and non-binding proposal to acquire all of the outstanding shares of common stock of the Company for $190.00 per share in cash (the "February 19 Proposal"). The offer letter noted that Novartis was prepared to move quickly to announce and execute a transaction and requested a period of exclusivity to negotiate the terms of a definitive agreement.
On February 22, 2018, the Board held a meeting with members of senior management, representatives of Cravath, and, for portions of the meeting, representatives of Goldman Sachs and Centerview, to discuss the February 19 Proposal and certain other topics. At the meeting, the representatives of Cravath reviewed with the members of the Board their fiduciary duties in the context of an unsolicited offer to acquire the Company and representatives of Goldman Sachs and Centerview reviewed with the Board their respective preliminary financial analyses of Novartis's proposal. The Board discussed its view that the Company needed to maintain its focus on its business and preparation for approval and commercial launch of AVXS-101 and the risks that consideration of a transaction could pose to the Company, including the potential for distraction at a crucial point in the regulatory process and that the potential timing of a transaction could impede the Company's ability to successfully launch AVXS-101. The Board discussed, in particular, the Company's near-term need to begin to hire a sales force to execute the launch of AVXS-101. At this meeting, the Board discussed with senior management the Company's prospects generally and assumptions relating to launch dates and pricing models in respect of AVXS-101 made by senior management. Finally, a representative of Cravath discussed with the Board potential regulatory risks relevant to the Board's consideration of a transaction with Novartis. The Board determined to engage in discussions with Novartis and seek, among other things, an increase in the offer price and a clear understanding and agreement from Novartis of the need for closing certainty and the allocation of certain regulatory, manufacturing and clinical risks to Novartis for the period between signing and closing. The Board also determined to reject Novartis' request for a period of exclusivity. The Board also directed management and
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representatives of Goldman Sachs and Centerview to engage in discussions with Company C to explore its interest in an acquisition of the Company.
On February 28, 2018, Mr. Nolan spoke telephonically with Dr. Narasimhan. During the call, Mr. Nolan informed Dr. Narasimhan that the Board had rejected Novartis' request for a period of exclusivity, but that the Board was willing to engage in discussions with Novartis regarding a potential transaction, with the expectation that Novartis would increase its offer price following a targeted due diligence review. Mr. Nolan also informed Dr. Narasimhan about the importance to the Board of certain key risk allocation and transaction certainty terms, including with respect to Novartis's commitment to obtain regulatory approvals in respect of the transaction, and reiterated the Board's concern that discussions regarding a potential transaction could interfere with the Company's business and its preparation for approval and launch of AVXS-101. Mr. Nolan and Dr. Narasimhan also discussed certain next steps regarding the due diligence process.
On March 1, 2018, the Company provided a confidentiality agreement to Novartis, which was negotiated over the next several days among representatives of the Company, Novartis, Cravath and Hogan Lovells US LLP, Novartis's legal counsel ("Hogan Lovells"), and executed on March 5, 2018. Also on March 1, 2018, Novartis provided a diligence request list and a number of diligence questions to the Company. Access to the Company's online data room was granted to Novartis on March 5, 2018.
On March 6, 2018, Mr. Nolan emailed Dr. Narasimhan to emphasize the Board's view that Novartis would need to provide a high degree of closing certainty, including committing to take any and all actions required to obtain regulatory approvals in respect of a potential transaction and assuming the risk with respect to certain key regulatory and clinical developments between signing and closing of a transaction and Mr. Nolan and Dr. Narasimhan further discussed these matters telephonically on March 7, 2018.
Also on March 6, 2018, representatives of Cravath spoke with representatives of Hogan Lovells regarding such key risk allocation and closing certainty terms.
On March 8, 2018, representatives of Goldman Sachs and Centerview spoke telephonically with representatives of Company C, who confirmed Company C's interest in exploring a potential acquisition of the Company. Following this conversation, at the direction of the Board, representatives of Goldman Sachs and Centerview provided a confidentiality agreement to Company C, which agreement was negotiated over the next several days and executed on March 10, 2018.
On March 9, 2018, representatives of Cravath spoke telephonically with representatives of Hogan Lovells and Freshfields Bruckhaus Deringer LLP ("Freshfields"), Novartis's outside regulatory counsel, regarding the importance of closing certainty to the Board and various regulatory considerations relevant to a potential acquisition of the Company by Novartis.
On March 10, 2018, representatives of the Company met in-person with representatives of Novartis to discuss, among other things, the Company's manufacturing process and certain safety, efficacy, regulatory, commercial and other matters, including the Company's Rett syndrome and amyotrophic lateral sclerosis programs.
On March 12, 2018, representatives of Cravath sent a draft merger agreement to representatives of Hogan Lovells.
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On March 12 and 13, 2018, representatives of the Company and Novartis discussed, as part of Novartis's diligence review, various matters related to AVXS-101 clinical trials.
In addition, during the period between March 14, 2018 and March 18, 2018, Novartis continued its diligence review of the Company. During this period, the Company continued to make available additional diligence information and materials, and representatives of the Company and Novartis conducted frequent diligence calls.
On March 14, 2018, Mr. Nolan spoke telephonically with a representative of Company C and expressed the Board's view that, in light of the Company's upcoming clinical and regulatory milestones, a potential transaction would need to provide a high degree of closing certainty.
On March 16, 2018, representatives of the Company met in-person with representatives of Company C to discuss, among other things, the Company's manufacturing process and certain clinical, regulatory, commercial, legal, human resources and other matters.
On March 16, 2018, representatives of Cravath discussed with representatives of Company C's outside counsel certain key transaction terms relating to closing certainty and the allocation of certain regulatory and clinical risks between signing and closing. Following such discussion, representatives of Cravath sent a draft merger agreement to representatives of Company C's outside counsel.
Also on March 16, 2018, representatives of Hogan Lovells sent a revised draft merger agreement to representatives of Cravath.
On March 18, 2018, representatives of Cravath and Hogan Lovells discussed certain terms of the revised draft merger agreement provided by Hogan Lovells, including the provisions relating to closing certainty and certain risk allocation provisions that had been previously discussed among the Company, Novartis, Cravath and Hogan Lovells. Also on March 18, 2018, Mr. Michael B. Johannesen, Senior Vice President, General Counsel and Chief Compliance Officer of the Company, informed representatives of Novartis that the Company had decided to postpone a proposed site visit by Novartis of the Company's manufacturing facility and, among other things, delay further diligence in light of the lack of alignment between the Company and Novartis with respect to such closing certainty and risk allocation terms.
During the weeks of March 19 and March 26, 2018, representatives of the Company continued to speak telephonically and meet in-person with representatives of Company C to discuss certain diligence items.
On March 21, 2018, Mr. Nolan spoke with a representative of Company C. During the call, the representative of Company C provided a preliminary indication of interest to acquire the Company for $175.00 per share in cash and stated that Company C was investigating potential sources of additional value.
On March 22, 2018, representatives of Company C's outside counsel sent a revised draft merger agreement to representatives of Cravath.
On March 23, 2018, Mr. Nolan spoke telephonically with Dr. Narasimhan and Mr. Sheail to discuss certain key closing certainty and risk allocation terms proposed by Novartis, including the proposed outside date for the transaction, the commitments Novartis was prepared to make in order to obtain regulatory approvals for the transaction and the allocation of certain regulatory and clinical risks between signing and closing.
On March 25, 2018, representatives of Cravath spoke telephonically with representatives of each of Hogan Lovells and Company C's outside counsel regarding various provisions of the draft merger agreements.
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On March 26, 2018, representatives of Cravath sent a revised merger agreement to representatives of each of Hogan Lovells and Company C's outside counsel.
Also on March 26, 2018, Mr. Sheail, Ms. Keren Haruvi and Mr. Augusto Lima, Global Head of Mergers & Acquisitions at Novartis and Head of Legal Transactions at Novartis, respectively, had a telephonic meeting with Mr. Johannesen and Mr. Session regarding various post-closing employee retention matters and certain matters related to the diligence process.
On March 27, 2018, Mr. Sheail, Mr. Nolan and Mr. Johannesen held a telephonic discussion regarding certain key employees.
On March 28, 2018, Mr. Nolan spoke telephonically with a representative of Company C. During the call, the representative of Company C provided an improved proposal to acquire the Company for $185.00 per share in cash and reiterated that Company C was investigating potential sources of additional value.
On March 30, 2018, Mr. Nolan spoke with Dr. Narasimhan and Mr. Sheail. Dr. Narasimhan provided an improved offer price of $200.00 per share in cash and proposed, among other things, a "reverse termination fee" of 5.0%, a 3.5% Company termination fee, in each case based on the fully diluted transaction equity value calculated using the proposed offer price, and an initial outside date of eight months with a possible four month extension. During the call, Dr. Narasimhan also requested that the Company enter into an exclusivity agreement with Novartis at this stage. Mr. Nolan then informed Dr. Narasimhan and Mr. Sheail that the Company was also engaged in discussions with another counterparty regarding a potential acquisition of the Company. The parties then engaged in a discussion of the relative merits of Novartis's revised proposal, including with respect to antitrust matters and proposed outside dates.
Also on March 30, 2018, Hogan Lovells provided a further revised draft of the merger agreement to Cravath. Additionally, representatives from Hogan Lovells and representatives from Cravath held a telephonic meeting to discuss certain terms of the transaction, including the treatment of Company employee equity awards, whether the parties would enter into exclusivity, the outside date for the completion of the transaction and the treatment of the Company's employee equity awards.
On March 31, 2018, at the direction of Company management, representatives of Goldman Sachs and Centerview spoke telephonically with representatives of Novartis and Dyal Co. LLC, Novartis's financial advisor, and discussed, among other things, the Company's expectations regarding timing, price and certain contractual terms regarding a potential transaction. The representatives from Goldman Sachs and Centerview indicated that the potential third party bidder had recently provided a competitive proposal to acquire the Company and had committed to a "hell-or-high-water" antitrust efforts standard, and that the Company expected that a transaction with such third party would be consummated in less than three months following the execution of a definitive merger agreement. Additionally, at the direction of Company management, the Goldman Sachs and Centerview representatives stated that the Company would be seeking final proposals from Novartis and the third party bidder on April 6, 2018 and that they would be sending out a process letter on April 2, 2018 that would provide information confirming the expectation of final proposal submission, including timing requirements.
Also on March 31, 2018, at the direction of Company management, representatives of Goldman Sachs and Centerview spoke telephonically with a representative of Company C and discussed, among other things, the Company's expectations regarding timing, the fact that Company C's latest offer price was not the highest price currently proposed and certain contractual terms.
On April 2, 2018, the Board held a meeting with representatives of Cravath and members of senior management, and, for portions of the meeting, representatives of Goldman Sachs and Centerview. A representative of Cravath reminded the Board of its earlier discussion relating to its
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fiduciary duties and reviewed the key legal terms of the draft merger agreement with each of Novartis and Company C. The Board discussed, among other things, the ongoing process and negotiations with each of Novartis and Company C and the Company's operations and upcoming regulatory and clinical milestones. Management and representatives of Cravath also discussed with the Board the potential regulatory review process in respect of a transaction with Novartis relative to Company C.
Also on April 2, 2018, Mr. Nolan spoke telephonically with Dr. Narasimhan regarding certain key terms contained in the draft merger agreement, including the proposed outside date for the transaction. On the same day, at the direction of Company management, representatives of Goldman Sachs and Centerview sent a process letter to each of Novartis and Company C requesting that it submit a revised draft merger agreement by April 4, 2018 and a final proposal, including offer price and a revised merger agreement, by noon Eastern Time on April 6, 2018. Later that day, representatives of Cravath provided further revised draft merger agreements to each of Hogan Lovells and Company C's outside counsel.
In the late evening of April 2, 2018, Mr. Nolan received a phone call from a representative of Company C. The representative informed Mr. Nolan that Company C was uncomfortable increasing its offer price, especially in light of the stage of approval regarding AVXS-101.
On April 3, 2018, representatives of Centerview spoke telephonically with a representative of Company C. The representative of Company C emphasized Company C's strong interest in an acquisition of the Company, but confirmed that Company C was not in a position to increase its offer price at this point in the Company's development stage and that Company C was therefore withdrawing from the process.
Also on April 3, 2018, representatives of AveXis hosted a visit for representatives of Novartis at the manufacturing facility of AveXis in Libertyville, Illinois. Subject matter areas of discussion included manufacturing, quality control, engineering and health and safety.
Also on April 3, 2018, Mr. Johannesen emailed Mr. Sheail and Mr. Lima regarding certain terms of the draft merger agreement, including the proposed outside date for the transaction.
On April 4, 2018, representatives of Hogan Lovells sent a revised draft merger agreement to representatives of Cravath.
On April 5, 2018, various representatives of the Company and Novartis spoke telephonically regarding certain outstanding contractual terms. On the same day, Cravath provided a revised draft of the merger agreement to Hogan Lovells.
On April 6, 2018, the Company received a final proposal from Novartis that had been approved by Novartis' Board, which outlined the acquisition of the Company for $218.00 per share in cash and an initial outside date for the transaction of three months, subject to an increase to $225.00 per share in cash in the event Novartis decided to extend the outside date in accordance with the terms of the Merger Agreement. The final proposal also provided for a termination fee that may be required to be paid by the Company under specified circumstances, including termination of the Merger Agreement by the Company to accept a Superior Proposal, equal to $284 million and a "reverse termination fee" equal to $437 million required to be paid by Novartis under specified antitrust-related circumstances, which fee would increase by an additional $105 million to $542 million if the merger agreement is terminated within 30 calendar days after the initial outside date, by an additional $195 million to $632 million if the merger agreement is terminated between 31 and 60 calendar days after the initial outside date or by an additional $285 million to $722 million if the merger agreement is terminated more than 60 days after the initial outside date. Throughout the course of the day on this date, representatives of Hogan Lovells and representatives of Cravath discussed and exchanged comments to the draft merger agreement. At the conclusion of these discussions, the parties had agreed on the final form of merger agreement.
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Shortly thereafter, the Board held a meeting with representatives of Cravath, and, for portions of the meeting, members of senior management and representatives of Goldman Sachs and Centerview. Representatives from Cravath reviewed with the Board their fiduciary duties as well as certain key legal terms of the Merger Agreement. Representatives from Goldman Sachs reviewed with the Board the key financial terms of the Merger Agreement and Goldman Sachs' financial analysis of the Offer Price of $218.00 per Share, and rendered to the Board Goldman Sachs' oral opinion, which was subsequently confirmed by delivery of a written opinion dated April 6, 2018, that, subject to the factors and assumptions set forth therein, the Offer Price of $218.00 per Share to be paid to the holders (other than Novartis and its affiliates) of Shares pursuant to the Merger Agreement was fair from a financial point of view to such holders. Representatives from Centerview reviewed with the Board the key financial terms of the Merger Agreement and its financial analysis of the Offer Price of $218.00 per Share, and rendered to the Board its oral opinion, which was subsequently confirmed by delivery of a written opinion dated April 6, 2018, that, based upon and subject to the various assumptions made, procedures followed, matters considered, and qualifications and limitations upon the review undertaken in preparing its opinion, the Offer Price of $218.00 per Share to be paid to the holders of Shares (other than Excluded Shares (as defined herein)) pursuant to the Merger Agreement is fair, from a financial point of view, to such holders. For a detailed discussion of Goldman Sachs' Opinion and Centerview's Opinion, please see below in "—Financial Analyses and Opinions". The written opinions delivered by Goldman Sachs and Centerview are attached to this Schedule 14D-9 as Annex A and Annex B, respectively. Following additional discussion and consideration of the Merger Agreement and the Offer, the Merger and the other transactions contemplated by the Merger Agreement, the Board unanimously (i) approved the Merger Agreement and declared that the Merger Agreement, the Offer, the Merger and the other transactions contemplated by the Merger Agreement were advisable and fair to, and in the best interests of, the Company and its stockholders and (ii) resolved to recommend that the stockholders of the Company accept the Offer and tender their shares of Company Common Stock pursuant to the Offer. The Compensation Committee of the Board also approved certain employment compensation, severance and other employee benefit arrangements with respect to the employees of the Company.
Later in the day on April 6, 2018, Mr. Nolan called Dr. Narasimhan and Mr. Johannesen called Mr. Sheail, in each case, to inform Novartis that the Company's Board had unanimously approved and declared advisable the proposed transaction with Novartis and thereafter on April 6, 2018, the Company, Novartis, and Purchaser executed the Merger Agreement.
Before the opening of trading on The Nasdaq Stock Market LLC (the "Nasdaq") on April 9, 2018, the Company issued a press release announcing the execution of the Merger Agreement and the forthcoming commencement of a tender offer by Purchaser to acquire all of the outstanding Shares at the Offer Price.
On April 17, 2018, Purchaser commenced the Offer and the Company filed this Schedule 14D-9.
Nope. Just a bunch of investors with 7 digits invested with ears to the ground in the industry. I believe what some of them say and also know a few have been wrong on the science. (Prurisol) Every drug in ipix pipeline could flop. It’s not proven until it hits the market.
But one has suggested there is a goal to be rocking a trial by summer. That gives us 5 months. This is nothing more than people saying ipix is going BK by April. All opinions. Who you believe is the difference.
What if this Patent was key to some ink? What if March comes along and a very detailed deal is done and BP owns the trial and can move it towards Lightspeed with fda.
Tides will turn. IMO. I will pick up another 60k shares because I believe in this company. That is why I’m here.
They have $700K. Stock was at $1 with 35K in bank and no financing.
Here is Dr B ; “We are active in advanced discussions with a variety of pharmaceuticals companies. Our goal remains to secure a partner for advanced clinical development of Brilacidin as a new therapeutic for Oral Mucositis and Inflammatory Bowel Disease. At that time, we intend to focus our resources on the next stages of development for Brilacidin, notably dermatologic indications, and Kevetrin as a novel anti-cancer agent to build upon the completed studies.”
They have a plan and it’s about to go down baby
From my sources, a phase 3 trial is to begin in May/June and that is the goal. How do you think that is going to happen that fast? Big muscle coming from behind. There is a race for OM...BP is aware. IMO.
A deal will happen. Not a 300 million buyout is all I’m saying. IMO.
Add Designations which could add 3-7 additional years. Big money coming.
I’m against this talk. Watch what happens when ipix inks it’s first mega deal for OM and IBD. Everyone will be talking about 20-30 plus valuations.... The mojo is coming here folks. 3 years of down trend and the scraping of P has owned the night. OM is untapped and estimates have it between 1-2 billion a year. I’ll take an instant 300-400 million per year upon approval and work up to a billion in first 5 years on market. An approved PREVENTATIVE swish and spit drug will be prescribed to every HM cancer patient under CR. Big big money ahead of us.
IBD on the other hand.......many of many billions if B works as it suggests.
300 million is a slap in the face for a buyout. Leo would never accept that. IMO.
Good things take time. Negotiations back in action per Art and he said there is PLENTY OF INTEREST IN B
I’m with you on short term. Everything changes with ink
Acne on tap once partner commits.
IBD is a 40 billion plus market come 2020