...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: RVX AGM 12 Dec 2017 meeting note, Q&A and comments

Acknowledgements first:

 

imtesty - A great big thank you to imtesty for doing the voice to text conversion function on the presentation the morning of 14 Dec. Without that I would not have been able to decipher my cryptic notes in as much detail as I have. Wherever I have quoted I believe it is directly from imtesty’s conversion.

 

Absolutely – Thank for one of the best laughs I have had in a long while. The comment of “The short bald guy sitting near me” from your post at 12:15 on 13 Dec was hilarious. That description was fitting for 7 or 8 guys in the crowd sitting in various places around the room. From my observation they (all of them) along with most people in the room were smiling. What’s even funnier is 10 or 11 years ago when I first started going to the RVX AGM’s all those guys had hair and mostly it wasn’t gray. Thanks again for the laugh.

 

In the Q&A section where there is a * this is where I have verified the point with 2 or 3 other people as I may have missed something or thought I missed something.

 

Setting the stage.

 

The weather in Calgary was beautiful. 12C or about 56F and sunny versus last years freezing blizzardy snow filled day. There were about 100 attendees to the AGM this year. I don’t remember the last time I saw that many people at an AGM. Maybe around the time of the ASSERT trial, 2010 or 2011. In general I would say that the aura of the company employees and management was one of confidence through body and speech whether at the podium, in small groups or talking one on one. 

 

The meeting structure was a little different as the business part started at 1pm then about a 20 minute break followed by the webcast. I believe this happened as a result of the business portion of the meeting going so quickly and then having to wait until 1:30pm to keep on tack for what was the published time of the webcast. This break gave attendees an additional opportunity to speak to management if they desired.

 

The webcast its self is available on the company website or from a link that was posted on this forum so there is no need for me to regurgitate each slide. There was however a number of slides and comments that peeked my curiosity.

 

Slide 4 – The share ownership pie chart. Efung Capital is a new listing on the share ownership pie chart who now owns 1.7% of RVX or about 3 million shares.

 

tada - This is the first time I have heard or seen this name. It was not on the pie chart from the 17 Oct presentation. I don’t see any issue with this just that this is the first I have seen it.

 

Efung Capital is a venture capital firm specializing in early stage and growth capital ventures. It seeks to invest in mainly in healthcare and biopharmaceuticals. It typically invests between RMB 5 million (USD 0.73 million) to RMB 50 million (USD 7.27 million) per transaction. For stock transfer, the firm seeks to exit through the portfolio’s shares transfer, mergers, acquisitions, and back-door listings. For other channels, the firm seeks to exit through shareholders’ buyback and management acquisition. The firm is based in Shenzhen, China. (Taken from Bloomberg, not inclusive)

 

tada – The cash burn rate was stated at just over C$40 mil per year? To me this sounds like the inflation rate on my grocery bill. This past summer their burn rate was stated as $2.8 mil per month, earlier in the fall at $3 mil per month and now this winter just over $40 mil per year or $3.3 mil per month. I understand that it costs money to have more people in the trial but we have only had about 300 patients added to the trial since the beginning of the summer. It is what it is but that is an observation that I had.

 

Slide 5 – Capitalization

 

tada - Don made a comment something to the effect of “the market size and capitalization I did yesterday”. I found this very interesting as the slides presented in a couple of past presentations were apparently put together by a third party contractor which is where some confusion came from. I’ m hoping this now means that we will no longer be subjected to that potential confusion in the future.

 

Slide 6 – Talking about accomplishments in 2017 and specifically the Publications, 5 last year and 5 already known in the works for 2018.

 

tada - This is all about the exposure that many on this forum have talked about both for RVX and epigenetics/BET inhibition specifically. Boys and girls this is happening at a greater pace each year not only for RVX but for the biotech industry in general. Keep up your efforts GAC you are part of this solution.

 

US Patients – “the ability to have US patients in the BETonMACE trial”, “that’s a work in progress”, “we should have our first patients in the trial early next year”

More on this in the Q&A

 

The comment about repaying the loan and institutional funds not being able to own the stock with debt outstanding: DM clearly stated that many of the funds out there in Toronto, New York and other places have “corporate mandates”, one of them being not able to invest in a company with long term debt.

 

tada - My interpretation was; small biotech companies with long term debt. A corporate mandate is very different than a rule as someone on this board may have misunderstood over the last few days.

 

Debt has been repaid; the monkey is now off the back

 

Being the leader in the field is both a beautiful and a horrible place to be because the knowledge curve has not caught up to you yet. More publications equal more credibility. This is happening at a faster rate each year.

 

14 major announcements this year & we will do our best to keep it up for next year.

 

Slide 9 – Apabetalone, proteins may require medication because they are producing too much or too little of what they are suppose to, we believe intently that fixing it at the transcription level is the smart approach. We’re pretty advanced in this, we know what we are talking about and it’s helping us in our discussions in both regional licensing deals and pharma discussions.

 

I highlighted these statements by DM as they were very significant thoughts in a small group talk after the meeting was over. I was not part of the conversation but picked the brains of a couple of people that were in a little get together that evening. In a conversation with Ken Lebiota, SVP Business Development said “the Pharma companies are now getting it”. More on that later.

 

We’re a selective BET inhibitor primarily for BRD4-BD2. We have follow-on compounds that can be selective for just about any one of those (BRD-BD family of targets).

 

My interpretation here is that money is/was the big issue in progressing this science. I have said it before and will again; What ever BP ends up with this technology or the company and all of the IP and is able to put reasonable R&D dollars into it will make fortunes for years to come.

 

Slide 13 – This drug has a very profound and statistically significant impact on MACE reduction, particularly in diabetic patients and those with an inflamed vasculature.

 

Nice to see a third party (Dr Nicoles) confirmation of the data from the ASSURE trial even if it is 4 years after the fact. What blows me away on this slide is the increase in events after the dosing has stopped at 180 days. It will be very interesting to me to see if the same pattern of dramatically increasing events occurs after dosing is completed in this much longer dosing period of the BETonMACE trial where the average time will be 18ish months.

 

Slide 16 – BETonMACE now in 19 countries including the USA. Pretty much an even 50/50 split between atorvastatin and rosuvastatin. In the planning of this trial they were going to run it with rosuvastatin only and almost did but in early discussions with the FDA it was clear that they wanted both statins which is the route that was taken. It is a good thing that both statins were used as FDA approval would not have happened otherwise.

 

There is more on the FDA approval in the Q&A.

 

They have already dosed 1800 patients with apabetalone in all trials so far. They know it’s a good product, is safe and is meeting the criteria they had expected it to. In the last year not only was the US added but also Russia and Taiwan (which was part of the Hepalink deal).

 

Slide 17 – Very interesting, hints of what we may see in the future. Q1 and Q2 2018 look very busy, BETonMACE is ongoing and 2 more clinical trials will hopefully begin recruiting. Here is the exciting part “We have a lot of activity in the clinic right now, more so than we could possibly do ourselves. Some of it we try to partner and some of it we try to get others to pay for. I can tell you that we have some very good success in that coming up.” There are a lot of interested parties in some of the work that RVX is doing. The first 2018 news should be the announcement of the first patient in the US being dosed in the BoM trial and second the launch of the dialysis trial. BoM full enrollment in Q2, maybe Q3, Fabry’s first patient recruited in 2018 and top line data for BoM late next year (2018). The order of starting trials and getting data may be different than stated based on what actually happens in the clinic.

 

My read of these comments; We are going to announce a regional and or partnering deal in Q1. See my comments in the Q&A section about LOI’s.

 

Slide 21 – Regarding CKD - The sick patients had 288 proteins in plasma that were different than the healthy volunteers. After just one dose of apabetalone 152 of those proteins were reregulated, mostly down. What this proved was that by correcting these 152 proteins in the sick

patients, and having very little effect on the healthy patients, “that was the first time that anybody had any really concrete evidence in epigenetics of just how powerful and effective this is.” Bringing the complement back to the “basal” or normal level was also good as it was important in showing a clean safety profile. Infections were always lower in the treated patients in past trials.

 

Slide 25 – Talking about the BETonRENAL trial. “We hope to launch it in Q1. It was a little hard to do on time last year when we were so busy working on $100 million in financing to remove the debt and move forward. It’s a lot easier to maneuver and operate right now.” A list of prominent Drs led by Dr Kam Kalantar put together the clinical advisory board for this trial in conjunction with Ken Lebiota SVP of RVX. This advisory board is the who’s who of nephrology. This group of Drs co-authored the paper that was released this morning. The paper is so new I haven’t read it yet.

 

 

tada - My take on this comment was they need to have the money in hand before they can move forward on any front. We will get more and exciting information on the CKD trial when it happens.

 

Slide 30 – The wrap up – We are a phase III company, a market leader with significant potential, ten million patients in the top 7 markets only with just our lead indication. We are advancing programs in CKD and Fabry’s, and PNH that may or may not work out next year, but if it does work out, it will be early in the year. We have a very well established safety profile with over 1800 patients dosed with apabetalone so far, which is huge.

 

Just before closing the webcast DM says “I’m looking forward to the next steps”

 

Once the webcast was completed the floor was open to questions. I had a hard time hearing most of the questions but got most of the answers so the fallowing is my best shot. For answers that I did not hear clearly I verified with others that were in the room. This will be marked with an *

 

Q: What is the current relationship between RVX and Eastern

A: They are an investor just like every other investor. They have been good investors to deal with.

 

Q: Does Hepalink have the right to participate in all future financings.

A: Hepalink has the option to but not the right to participate in any future financings

 

Q: Can patients currently with CKD on dialysis, can they go off dialysis after being dosed with apabetalone.

A: Answer is unknown

(I didn’t quite understand the question and think maybe DM didn’t either but to my knowledge there are no patients in this BoM trial that are or were on dialysis so it seemed to be a safe answer)

 

Q: When do you anticipate getting the Futility Analysis results (or something to that affect)

A: Ours is not really a true Futility Analysis as with a very successful FA the trial could be over and ALL the patients could be put on apabetalone. I missed the rest of the answer but is was something like – that can’t or wont happen in this trial. (as they need this safety data in order to get the EMA approval). This will be a sample size analysis at 188 patients.

 

Q: What is the enrollment in BoM now.

*A: We are at about 2100 now. We closed down some inactive sites and have some sites maxed out at the 3% of trial total numbers. Other sites are getting close to being maxed. We purposely slowed down enrollment to allow for 300 recruits from the US. Under the new rules we only need 100 patients in the US. Our next meeting with the FDA is in early January. You will be hearing more about this soon. (This answer is not the exact words DM used as I had to check with others to get the full answer that I did not hear. Though I did hear clearly that only 100 US patients would

be needed under the new rules. I will believe this when we hear more in early January after their next meeting with the FDA.)

 

Q: Is there a difference between the approval process for the FDA, EMA and China

*A: The FDA and EMA have their own approval process. Some countries will give the okay if the FDA okays a drug and some countries give approval if the EMA says okay. DM thought the Chinese followed the EMA. The EMA is expected to give approval before the FDA. (I had a hard time keeping up with listening and writing here so I had to check with others.)

 

Q: Is there still an LOI

*A: Yes there are multiple LOI’s. You will hear more about them soon.

 

That’s all I have from the Q&A. I know there was more but I just couldn’t keep up.

 

I really wanted to talk to Dr Kulikowski but each time I had the opportunity she was engaged with someone else. I would so like to have seen her talk briefly at the podium and say to this crowd what she said to those brokers in Feb. “If we were writing this script now we could not write it any better than the way this is playing out now.”

 

I did hear DM confirm with someone that there are multiple LOI’s

 

From a conversation with Ken Lebiota after the Zenith meeting: (I was not there, these comments are what I heard at a get together later that evening) Talking about Hepalink – Li Li gets it. He can see there is an opportunity for them to be the Pfizer of China. The $87 million investment that they made was much larger than they were initially talking about earlier in the year because he could immediately see the bigger picture. There are currently about 150,000,000 people in China with diabetes and that number is growing at over 10% annually. That is a huge market for our product. When you add all of the indications that only apabetalone looks like it will be beneficial to up, the Life of Patent Revenue could be in excess of $300 BILLION. (So lets dwell on this point for just a minute. 1st sales 2021, patent expires 2034, that’s 14 years of sales or patent life, ounce sale start. That equals $21.4 billion in annual sales. This is apparently a conservative number if all indications work out. Last week I replied to a question from JB2 and gave my Low, Medium and High range estimate for a share price and GAC was chastised for repeating my high range which I think was $117/share. Let’s use KL’s numbers just for fun…$300B divided by 14 is $21.4B in annual sales divided by 198 mil shares equals $108/share. The $300B is apparently a conservative number if all indications work out. There is no doubt that the moon and stars need to line up while you’re standing on your head facing North for this to become reality but hay my spitball number is not that far from KL’s after all is said and done.) Ken said that in his discussions with the pharma companies, they are now getting it. It is now a much easier conversation with the right people than it was just a year ago. There should be 1 more independent analyst report out this year, hopefully in the first quarter and 3 other reports updated. There was a whole lot more to that conversation that seems to have escaped me. (Did you know that all of the problems of the world can be resolved while consuming liberal amounts of wine and beer?)

 

After the Q&A for the Zenith presentation was finished(which was cut short) DM said if you have any more questions for Zenith please talk to Henrik over here and if you have any more questions on Resverlogix please talk to Ken Lebiota over there. I have to go to the airport now to talk to some institutions in the east.

 

tada – I found this very interesting. The president of a public company, in front of a very interested crowd that in my estimation held more than 10 million shares left to go and talk to an institution just one week before Christmas. DM did not say he was going to talk to institutional investors, he said he was going to talk to an institution in the east. I really wondered what that actually meant??

 

There were a number of new faces in the crowd this year. At least 3 of them were Drs that I got introduced to. Maybe some of the scientific presentations made in the past year were heard by academics for science sake. It sounded to me like there were some investments made as a result of those presentations.

 

Now my comments and takeaways from the presentation, Q&A and small group talks.

 

I got the distinct impression that the RVX management, board and employees that were present had a very confident aura to them, all of them. There is a lot happening with both companies now and in 2018. I truly believe it is time to strap yourself in for one heck of a ride in 2018. I believe the ride will be up but maybe down. Either way 2018 should blow this baby wide open.

 

I am really wondering if that trip to the east may bring Christmas cheer.

 

tada

 

These are my opinions. This is not investment advice. Where I did not hear the words myself I believe what I heard was from reliable sources. I am long RVX and ZCC. Do your own due diligence. Bolding is mine.

Share
New Message
Please login to post a reply