Relypsa CEO John Orwin: Fast-Track Funds?

1 00:00:06,950 --> 00:00:09,410 why am I so focused on the biotech space for your 2 00:00:09,410 --> 00:00:12,800 because in an environment where what's happening in the rest the world can 3 00:00:12,800 --> 00:00:14,660 question or markets on a day-to-day basis 4 00:00:14,660 --> 00:00:17,660 he's biotech companies have no real economic sense to the 5 00:00:17,660 --> 00:00:21,490 what so ever do not bother the Swiss franc and i'm bob with Japanese 6 00:00:21,490 --> 00:00:22,539 deflation their 7 00:00:22,539 --> 00:00:26,380 immunize against the forces that slammed the average speak these are businesses 8 00:00:26,380 --> 00:00:28,939 where if you do the homework and fall what's happening at the individual 9 00:00:28,939 --> 00:00:29,619 companies 10 00:00:29,619 --> 00:00:33,449 you may be surprised by disappointing clinical trial results 11 00:00:33,449 --> 00:00:37,460 or maybe a shock incision from the FDA but Chuck be blindsided by the European 12 00:00:37,460 --> 00:00:40,670 Central Bank with that in mind let me introduce you to 13 00:00:40,670 --> 00:00:46,840 relapse or L Y P that is a 1.15 billion dollar by a cat focused on developing 14 00:00:46,840 --> 00:00:49,460 treatment for kidney cardiovascular metabolic disorders 15 00:00:49,460 --> 00:00:53,520 specific you specifically relapse is getting closer to the finish line 16 00:00:53,520 --> 00:00:58,379 with upper tier amor are its treatment for hypercalcemia 17 00:00:58,379 --> 00:01:02,789 or high potassium levels in plain English a serious medical problem need 18 00:01:02,789 --> 00:01:04,089 some modern solutions 19 00:01:04,089 --> 00:01:07,590 as the best run calmly on the mark was approved in 1958 20 00:01:07,590 --> 00:01:11,029 are the FDA is expected to make its decision on procurement 21 00:01:11,029 --> 00:01:15,240 by late October and early this month we learned that it doesn't plan to convene 22 00:01:15,240 --> 00:01:18,990 Advisory Committee drug meeting on the drug and that got a that's really Bosh 23 00:01:18,990 --> 00:01:22,999 the question now is how big is the market selects a plan to talk in 24 00:01:22,999 --> 00:01:25,208 patients with heart failure and chronic kidney disease 25 00:01:25,209 --> 00:01:28,189 publisher millions which could potentially make this a blockbuster drug 26 00:01:28,189 --> 00:01:28,840 in short order 27 00:01:28,840 --> 00:01:32,499 however new drug wants to be complicated special just relax a as potential 28 00:01:32,499 --> 00:01:35,189 competitor that's less than a year behind them in a development cycle 29 00:01:35,189 --> 00:01:39,849 short spectrum's stock a lot of upside potential major risk let's dig deeper 30 00:01:39,849 --> 00:01:42,149 with John or win the presidency overlaps a 31 00:01:42,149 --> 00:01:44,460 to hear more about his company and where 10 32 00:01:44,460 --> 00:01:49,170 storm welcome at my thank you very much jim is a delight to be on the show 33 00:01:49,170 --> 00:01:52,640 thank you for SAR nothing since 1958 34 00:01:52,640 --> 00:01:56,860 I mean that's got to be one of the most unmet needs out there it is a very 35 00:01:56,860 --> 00:02:00,960 significant unmet need and to the point you may be for about the size of the 36 00:02:00,960 --> 00:02:02,060 population 37 00:02:02,060 --> 00:02:06,030 there are between 14 and 15 million patients with 38 00:02:06,030 --> 00:02:09,449 clinically significant chronic kidney disease and 39 00:02:09,449 --> 00:02:13,109 love those patients approximately 20 percent or upward of 40 00:02:13,110 --> 00:02:17,820 three million patients will suffer from moderate to severe hyperkalemia 41 00:02:17,820 --> 00:02:21,950 and as you point out this is an important medical condition to treat 42 00:02:21,950 --> 00:02:26,260 these patients are at six significantly increased risk 43 00:02:26,260 --> 00:02:30,820 have cardiac arrhythmia and cardiac death bought one of the things that I 44 00:02:30,820 --> 00:02:32,320 thought that was that 45 00:02:32,320 --> 00:02:38,410 I to people know that they had they actually don't typically now 46 00:02:38,410 --> 00:02:41,770 it's largely a symptomatic on which is 47 00:02:41,770 --> 00:02:44,980 something that makes it that much more frightening I think on 48 00:02:44,980 --> 00:02:49,780 but positions will typically now because they're measuring patients blood counts 49 00:02:49,780 --> 00:02:53,010 on a regular basis whenever patients are seen 50 00:02:53,010 --> 00:02:57,510 I so a physician will usually know that a patient has an hi 51 00:02:57,510 --> 00:03:01,010 an elevated potassium but your point there haven't been any 52 00:03:01,010 --> 00:03:04,040 new treatment options in like sixty-two years 53 00:03:04,040 --> 00:03:07,950 and that the all option that exists is really not a good one it's not very well 54 00:03:07,950 --> 00:03:10,220 tolerated it hasn't been shown to be 55 00:03:10,220 --> 00:03:14,720 I effective in in clinical trials are subjected to the kind of scrutiny that 56 00:03:14,720 --> 00:03:17,750 I'm a new product like ours would be 57 00:03:17,750 --> 00:03:22,100 so it's really important to have new treatment options for these patients and 58 00:03:22,100 --> 00:03:24,330 treatment options that are well tolerated enough 59 00:03:24,330 --> 00:03:27,430 that they can be given on a daily basis because after all 60 00:03:27,430 --> 00:03:30,600 chronic kidney disease is a chronic disease 61 00:03:30,600 --> 00:03:34,970 right so quiet disease chronic treatment take your polymer in a power for meat 62 00:03:34,970 --> 00:03:35,550 week 63 00:03:35,550 --> 00:03:39,320 that's right now you'd actually take it daily 64 00:03:39,320 --> 00:03:42,640 patients in clinical trials took a tear Mar twice daily 65 00:03:42,640 --> 00:03:46,800 it's a powder that you mix with a very small volume of water 66 00:03:46,800 --> 00:03:47,710 and 67 00:03:47,710 --> 00:03:51,710 and you swallow it and the way it works is that as it goes through the digestive 68 00:03:51,710 --> 00:03:52,560 tract 69 00:03:52,560 --> 00:03:57,900 it actually binds to potassium and so it's taking potassium excess potassium 70 00:03:57,900 --> 00:04:01,470 and removing it from the body at 71 00:04:01,470 --> 00:04:04,750 potassium is a very important electrolyte for 72 00:04:04,750 --> 00:04:08,230 cardiac function and in fact I'm for human life 73 00:04:08,230 --> 00:04:13,250 the issue is that your body needs to control potassium within a relatively 74 00:04:13,250 --> 00:04:14,720 narrow range 75 00:04:14,720 --> 00:04:18,738 we all take in far more potassium than we need in our diets 76 00:04:18,739 --> 00:04:22,570 and physiologically normal healthy folks 77 00:04:22,570 --> 00:04:25,880 you just excrete the excess potassium through your kidneys 78 00:04:25,880 --> 00:04:29,480 but as the name would suggest chronic kidney disease patients 79 00:04:29,480 --> 00:04:34,180 have a compromised kidney function and therefore a compromise the ability to 80 00:04:34,180 --> 00:04:35,900 actually excrete potassium 81 00:04:35,900 --> 00:04:39,690 and that's why these patients are in need of something that they can take on 82 00:04:39,690 --> 00:04:40,810 a daily basis 83 00:04:40,810 --> 00:04:44,620 that will remove excess potassium really keep them in what we call the normal 84 00:04:44,620 --> 00:04:45,720 Kaylee mid-range 85 00:04:45,720 --> 00:04:49,650 where they're not at that elevated risk and that's exactly what our product us 86 00:04:49,650 --> 00:04:52,960 now what I took it is very bullish that the FDA 87 00:04:52,960 --> 00:04:57,530 did not are ask for an invite convening advisory committee meeting is obviously 88 00:04:57,530 --> 00:05:01,370 I think that means that the FDA wants to get something for these people if your 89 00:05:01,370 --> 00:05:02,050 drug works 90 00:05:02,050 --> 00:05:05,060 faster then typically that i've seen 91 00:05:05,060 --> 00:05:08,360 well my experience 92 00:05:08,360 --> 00:05:12,910 working with the FDA has been very constructive and productive one 93 00:05:12,910 --> 00:05:18,060 on its it's probably not good to true try to read into everything that they do 94 00:05:18,060 --> 00:05:22,050 but we're certainly encouraged by the fact that they decided at least for now 95 00:05:22,050 --> 00:05:22,610 that 96 00:05:22,610 --> 00:05:27,190 they don't need to convene a panel I think the way the product works and what 97 00:05:27,190 --> 00:05:28,900 it does is pretty straightforward 98 00:05:28,900 --> 00:05:32,650 and I think our team put together a very 99 00:05:32,650 --> 00:05:37,990 quality submission and also we conducted very rigorous clinical trials 100 00:05:37,990 --> 00:05:42,140 I in hundreds of patients to demonstrate both at the product 101 00:05:42,140 --> 00:05:45,520 I is effective in removing potassium but also that 102 00:05:45,520 --> 00:05:50,229 and what we saw was a tolerability profile suggesting that it could be used 103 00:05:50,230 --> 00:05:53,570 on a chronic daily basis so all those things I think 104 00:05:53,570 --> 00:05:56,900 are important and I think the FDA's decision 105 00:05:56,900 --> 00:05:58,910 at least for now not to hold the panel 106 00:05:58,910 --> 00:06:02,190 is encouraging on white one last quick question 107 00:06:02,190 --> 00:06:05,800 yeah I got punched for a house which where I heard that too much salt is bad 108 00:06:05,800 --> 00:06:08,690 and that you get a heart attack or you get high blood pressure from too much 109 00:06:08,690 --> 00:06:09,180 salt 110 00:06:09,180 --> 00:06:12,850 you said listen most people can live within a band but is a possible that 111 00:06:12,850 --> 00:06:14,790 your drugs much bigger than we think because 112 00:06:14,790 --> 00:06:18,150 a market each too much sugar in America eats too much saw 113 00:06:18,150 --> 00:06:21,970 could jurors be the answer for those of us who are being addicted to salt and 114 00:06:21,970 --> 00:06:25,020 just desired all the time even though we know it's bad for us 115 00:06:25,020 --> 00:06:29,820 well many of these patients are sodium restricted in so they can't 116 00:06:29,820 --> 00:06:33,520 take a lot of salt and that's why we designed our product 117 00:06:33,520 --> 00:06:36,830 to exchange calcium for potassium rather than sodium 118 00:06:36,830 --> 00:06:40,190 hide it or not introducing any new sodium impatience 119 00:06:40,190 --> 00:06:43,580 are but it's going to be important that they continue to 120 00:06:43,580 --> 00:06:47,370 I am limit the amount of sodium that they take in their diet 121 00:06:47,370 --> 00:06:51,240 particularly those patients with chronic kidney disease and patients with 122 00:06:51,240 --> 00:06:54,370 with heart conditions all this just makes a time a sense to me and I totally 123 00:06:54,370 --> 00:06:56,710 understand why your stock has been strong 124 00:06:56,710 --> 00:07:01,229 ot its if there's nothing since 1958 is a lifesaver certainly like to do 125 00:07:01,229 --> 00:07:04,229 John Owen president/ceo a burlap sack R L Y P 126 00:07:04,229 --> 00:07:07,530 thank you so much my pleasure thank you by guys 127 00:07:07,530 --> 00:07:10,850 understand the sole we come show you things there's 128 00:07:10,850 --> 00:07:13,960 unmet needs out there their companies to work in the summit needs 129 00:07:13,960 --> 00:07:18,050 and the when they strike gold you win and they save lives 130 00:07:18,050 --> 00:07:20,590 to which of course is far more important stick with me

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