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Strange day so far. And super quiet weekend. Hmmmmmnn
Not sure. Maybe nothing. We will find out soon. By end of month we should have clarity.
I already sent this example to Leo. TIAB - you are doing your best to diminish the potential of the drug Brilacidin but your time is coming to an end here son. start packing up.
As LR posted.....here is something we will see in the PR after the EOP2 meeting. "IF" we have failed to capture BTD, Leo will tell us why just like they did here:
“While the company believes the results of the Phase 2 NASH-CX trial may represent a breakthrough for patients with NASH cirrhosis and believes that the results meet the FDA requirements for Breakthrough Therapy designation, the FDA has not granted breakthrough designation at this time based on the Agency’s current assessment that additional confirmatory data are needed to identify the level of change in HVPG that is reasonably likely to predict clinical outcomes. Although we disagree with FDA’s decision not to grant Breakthrough Therapy designation at this time, we understand their position because our NASH-CX trial is to our knowledge indeed the first randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in HVPG in NASH cirrhosis patients. Importantly, the Phase 3 program will not be impeded by the lack of Breakthrough Designation at this time. The program continues to benefit from Fast Track designation which provides many of the same advantages as Breakthrough Therapy designation, including potential for accelerated approval and priority review.”
http://investor.galectintherapeutics.com/news-releases/news-release-details/galectin-therapeutics-proceeds-phase-3-development-gr-md-02-nash
December is here. FDA meeting in the middle of it! Get your tickets.
Everything since Aug will be replenished and returned and if cold feet...a fee will be delivered. On to the next and onward upward imo. Big news coming. IMO.
Excellent DD. Thanks
I’m with you. I never thought I’d have this many either. And the kicker.....through it all! The OS has been relatively stable in regards to 8 human trials and the purchase of a possible multi billion franchise drug.
I’m thankful for mako, SS, tiab and others as well. As bios from the past have shown......10 cents to 20 dollars can happen in a beat.
BOM prevented SOM by 70+ percent. That is AMAZING. Especially with a simple swish and spit therapy.
Do you realize how many patients are praying each night for this type of drug?
I will continue to support this stock not only for my financial gain, but for those really sick humans. Kevetrin will be next imo.
Not for long. Big boards and big time soon.
Insurance pays. Ipix has already met with congress and doctors to discuss BOM sachets and savings for the healthcare system through this prevention. Very positive steps have been taken already and that is part of the war room and for cda partners to find out more about.
Ipix will prevail.
Check out this oral cancer pill. 32k per month. Only 2-3k patients in US.
Imagine what Kevetrin Oral will do. And be worth!!!! Over 50% of all cancers have p53 mutation. Screw 10 billion. If it works we are talking 100’ billion worldwide.
https://www.forbes.com/sites/matthewherper/2018/11/26/loxo-and-bayers-amazing-drug-has-an-expensive-price/amp/
For a multi billion indication. It’s a good start. Someone is interested.......otherwise there would not be a term sheet
Think about the PRs over the years that have discussed interested parties and how the BPs have expressed what they want to see. We may have completed everything to a T with this final step in anchoring Brilacidin. Term sheet was finalized and non binding in August and 3-4 months later of back and forth and other parties.....maybe it’s our time.
If I were Leo! I would make one of them sign or include penalty if they do not prior to EOP meeting. Let’s get some cash!!!!
Who knows too......part of the already drafted offer could be the partner will pay off the MFO and the percentage to retire the series B shares. That would make some sense to me.....but lets wait and see if I am right for the one time in my life. :)
These DRUGS could be very powerful in the right hands. Hoping for a strong partner soon.
NO - It is called a SC 14D9. Here is the link PIX:
https://www.bamsec.com/filing/104746918002890?cik=1652923
I've read it 100 times and it gets more and more interesting as I piece together the timeline and quotes about "BUSINESS DEVELOPMENT" from IPIX throughout the years.
I think our time is coming and could be as soon as the next few weeks based on EOP 2 Meeting. The leverage is the EOP 2 Meeting and we may see something prior to the meeting if Leo uses this as leverage because we have several interested parties. Now is the time to make a deal and we have the leverage with this meeting IMO.
I'm cooking some popcorn now and hope my DD has pieced this together nicely. A deal will unlock this investment and get us back to a respectable MC and beyond. If IPIX closes this our future is legitimately BLUE SKY!
:). No buyout here. We will license bom and IBD first. Ipix will get to a respectable billion or so MC and then who knows. Kevetrin Oral could push this over 10-20 billion if successful imo. Crazy George numbers but it’s my belief in that drug and the potential. This rough patch will end soon
I found the CDA parts interesting. That part took lawyers and was fairly deep into the process. Leo advised we have around 20 and most likely more. I figured it was deep into the process but after reading this it clicked.
The data room part was interesting too and very deep into process. After cda obviously. Also they denied data room access based on potential interest and offer.
Its really interesting this example. Look around page 15ish...
This company is requiring agreements be made and CDA's to do more DD and would not allow them otherwise. It talks about "MINUTES" from the FDA meeting EOP 1 and how other suitors started jumping in after that meeting.
Very Very interesting. We have had almost 20 CDA's for a while now...just think about all the dinners and discussions with BP CEO's that we have had.
LOL Thanks. Retirement for the moment is many years away. That can change in a heartbeat though :)
Here is a great example of how long a deal can take:
Avexis - Novartis Talks began in 2015, offers began in 2017. Interesting to see the timeline:
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.
What does this mean?
"The minutes of the meeting will be made available by the FDA within 30 days of the meeting and the Company will be free to share them with any interested parties at that point"
I'll go back thru today's post to see the example. I just can't always read thru the dribble here on LEO LUCY garbage.
Pete, I agree. We all know and IPIX know that the next move is going to need to be concrete and bring in non-dilutive capital to move these drugs forward and the more money that is invested the quicker the indications and formulations can move. If we are lucky enough to capture a world leader BP we will also have the muscle to move even quicker.
IMO - Dr. B's plan has now played out and Brilacidin has been anchored and should have the ammo in the FDA meeting to move forward.
I am on the fence whether we received BTD to be honest. I think Leo would have PR'd it if we received it due to the low SP...so my gut is saying we will see a piece in the PR after the EOP meeting explaining why we did not get it. That does not stop forward movement to a phase 3 and we already have Fast Track Designation.
FDA Grants Fast Track Designation to Cellceutix’s Brilacidin-OM for Oral Mucositis
I would like to see the OS stay under 200million by the time we get a partner.
I'd like to see Prurisol also ASAP. I think that data which the management have ZERO inside info on actual numbers/data....could potentially be breakthrough worthy for an oral form. Imagine if we saw something like 40-50% PASI 75. That would be extremely valuable.
That is really harsh to be honest. Leo is a good man. He is trying to do something that almost always fails and that is bring viable drugs to the market. He is not only up against steep odds as drugs are related, but he is also fighting online ghosts who post things like you just did making him sound like he is out to collect a salary and does not care about this company or drugs and that is not fair. I have communicated with Leo and I believe he is an honest CEO and cares for his shareholders and drugs and his own successes. He owns alot of shares, he has lent the company millions and he works hard every day.
Please be careful on what you post as it is your opinion about a good man. I would bet all my shares you have never talked to him or Dr. B.
They have powerful drugs. They have aligned them well to show positive results across the platform and they are working tirelessly to bring a partnership to the table. I would not be surprised at all if we see a deal days after the EOP meeting.
First and foremost, May 2018 was when the final data was analyzed.
Here is a snip:
“Given the notable interest from global and specialty pharmaceutical companies that we have received following recent Brilacidin-OM data releases, we continue to carefully assess all of our potential alliance opportunities—toward cementing the best pathway forward,” said Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals. “The expedient advancement of Brilacidin-OM into later clinical development is a priority, as is the broader expansion of the complete Brilacidin Franchise.”
The email also leads us to believe that B for IBD could be included. We hope this is the case and ipix can move forward with strength from our new partner. Big money to be made here
The end of phase 2 meeting is set for mid December. We are curious if the Term Sheet BP will be attending.
This will be a huge meeting for future direction and dictate the deal terms in our opinion. Exciting times ahead
Happy Thanksgiving! It’s truly a time to be grateful.
The power of Now my friend:)
Ipix will prevail, just not today. The great fact of multiple drugs and multiple indications will allow this to flourish. Back at 120 million shares OS we hit almost 5 dollars per share and since have completed 3-4 additional mid stage trials tapping our cash reserve, but ipix did not fail a trial. Now 50 million additional shares OS later we see .11.
My close network owns atleast 1 million of those 50.
A miracle is coming down with cancer and being told you have 5 months to live to find out in 3 months there is no cancer. That is a miracle.
IPIX has extremely valuable assets that the market cannot see. This is not the first time the market has followed a falling knife trend to be very wrong once caught.
The day we fix the cash issue is the day we all rejoice! Well...most of us;)
There is an instantaneous 400Million per year reward for B-OM for preventative. It will skyrocket as they open up more....it truly is Blue Sky and come Dec the FDA is going to explain how to get there.
Also. They do not have data for P. The false rumors here on bad data and slow rolling is 100% false. They could deliver 95% pasi 75 for all we know still. The money is the issue and will be resolved and then they will deliver P data. Fact.
The falling knife is about to hit the ground and Leo is gonna pick that baby up and carve that fat turkey ;). Let’s roll IPIX.
I received an email from Leo 2 weeks ago. They are working hard on delivering partnership(s)! Get ready for a fun ride. I believe things will move extremely quick for OM to market. Just a wild guess. :)
I assume it is a big one. There are many ways the trial design can go and based on the milestones docs, they were going to have all trials and formulations paid for....so now add IBD, I’d assume they would not change that. Therefore, the way the FDA goes is a huge deal for THE DEAL! IMO.
It will be announced. Just not on your time. There is data that is discussed on how many patients have head and mouth cancer who receive the high doses of cisplatin. The company uses that number and states they can be prescribed B for preventative. What is that dollar amount per region in which they are negotiating. This is the numbers that will decide what type of money is placed down. They also need to know the FDA guidance and trial progression since ipix will need that money to run the phase 3. A lot goes into multiple partners. Imo
Well put! I’m in your camp. There is a deal or deals pending....we just have to watch the pot boil. BP will make so much money on BOM if they throw ipix a bone....it will happen.
Happy thirsty Thursday!
Tomorrow we dance with a few more interested parties. :). Hopefully Dr B and Leo are dressed to the 9’s! Big presentation day for ipix. SHOW THOSE IMAGES AND VIDEOS!
I questioned that as well to IPIX with no response. I do know that Private companies are sometimes quicker on all fronts....less hoops with SEC and more funding in other areas.
I am in the camp that we applied and were asked for more info this summer after final data was out. I think they reapplied in Sept sometime.
I recently communicated with Ipix about this subject and they are tight lipped.
I am hopeful that the end of phase 2 meeting for OM goes well. The main goal is to align with the fda and receive their blessing to move to phase 3 and let’s cross our fingers for an expedited path. From there......let’s see a deal imo.
The story is there. I mean there is absolutely no Bus Dev talk from 2017 K and prior. Add many PRs and emails I received from Leo....it’s clear they are working hard and many angles to secure partner. Imo