Enable Injections: Optimizing the CFO’s Role in Driving Growth

Episode 75 September 06, 2022 00:51:57
Enable Injections: Optimizing the CFO’s Role in Driving Growth
The Breakout Growth Podcast
Enable Injections: Optimizing the CFO’s Role in Driving Growth

Sep 06 2022 | 00:51:57


Show Notes

In this week’s episode of The Breakout Growth Podcast, brought to you by SAP, the world’s leading ERP provider,  Sean Ellis, and Ethan Garr chat with Tim Flaherty, Chief Financial Officer at Enable Injections.  MedTech is an area we hadn’t explored before, but we often find that going outside of what you know can offer new inspiration and insights for all of us working to drive breakout growth success. 

Enable Injections is developing enFuse®, an innovative device designed to improve the lives of patients who depend on medical infusions. This less disruptive system for delivering life-sustaining medications has the potential to drive step-change quality of life improvements for people living with a variety of conditions. Tim is leading the company as CFO, and believes this technology can have dramatic consequences for people who sometimes have to give up their ambitions just to live life around their infusion schedules.

But what does a CFO really do? Are they administrators who simply ensure that money flows in and out of the business efficiently? Or are they the strategic thinkers working to ensure the financial needs of the business support the mission? Tim certainly ascribes to the latter, and in this discussion, we learn how he brings a passion for patients into his work, and how he must constantly think about the future to ensure the long-term health of the business.

Medtech has its own unique challenges, and everything from fundraising to regulation comes into the growth equation, but ultimately, many of the themes we discuss are applicable across industries and markets.  

Before you jump in, learn more about SAP's cloud solutions for mid-size enterprises at sap.com/sme. If you have ambitious goals, SAP is the technology partner you need to scale and drive innovation. Instead of relying on stitched-together solutions to manage business finances, operations, HR, suppliers, and customer relationships, leverage the flexibility of SAP's cloud-based ERP solution to gain the insights that will help drive your breakout growth success.


Achieve breakout growth success now with SAP at bit.ly/3UUPDxJ

We discussed:

* Real patients: the hardships of living with in-clinic infusions (04:42)


* Big Tech/Big Pharma – The impact of big budgets for CFOs (07:39)


* Fundraising over $400 million to support a long-term strategy (11:01)


* Once approved, we have to take off like a rocketship! 16:28)


* When companies should hire a CFO (35:03)

And much, much, more . . . 

The Breakout Growth Podcast is also on YouTube: https://www.youtube.com/channel/UC-K_CY4-IrZ_auEIs0j97zA/featured


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Episode Transcript

Speaker 1 00:00:08 Welcome to the breakout growth podcast where Sean Ellis and Ethan Gar interview leaders from the world's fastest growing companies to get to the heart of what's really driving their growth. And now here are your hosts, Sean Ellis and Ethan Gar Speaker 2 00:00:27 In this week's episode of the breakout growth podcast, Ethan Gar and I chat with Tim flatty chief financial officer of enable injections. So if you have family or friends who have lived with health conditions that require infusions, and you're probably gonna be aware of how disruptive that can be to their lives, Enable injections is working to change that with this ingenious medical device that could potentially reduce that burden to a simple and effective at home process. So Ethan, what stood out to you from this interview? Speaker 3 00:00:57 You know, Sean MedTech is such a different animal for us. I didn't really know what to expect coming into this, but I feel like when you and I get out of our comfort zone a little bit, we end up learning so much, you know, I was hoping we'd be able to use this time with Tim just to see how the CFO roll through, you know, what it looks like through this other lens. And that that angle would end up being interesting for our listeners. And I think on that front, I think this really delivers. So I think it's it's, it was actually a really fun and interesting conversation. You know, you probably noticed that Tim kept talking about the people who have to live with infusions and how this could change their lives. Really. It was the same thing we always hear with, you know, companies that are really growing fast. The mission is be behind the business is what really counts and just reinforced that regardless of the industry, what matters is the impact you work, you, the impact your work has on other people's lives. Speaker 2 00:01:44 Definitely at the other end of the telescope is a human being and a challenge. Your job is to make their lives better. So if you saw the title of this episode and you thought, oh boy, here we go, CFO equals being counter big. Jan, I think you're gonna be pleasantly surprised. Uh, you know, Tim focuses on designing a financial strategy that ensures that enable injections will remain on sound footing through each phase of the long and complex process of getting a pharmaceutical product to market. They've actually raised more than 400 million. And, uh, that that's really trying to set them up for the rocket ship type growth that they're expecting once they have those regulatory approvals. Speaker 3 00:02:28 Yeah, Tim definitely doesn't make you feel like it's just nuts and bolts and you know, numbers. He, he really brought it to life and you know, this is definitely a different process than what most of the tech companies we talk to usually have, you know, they don't go through this kind of regulatory process and all that, but I think it just shows why the CFO role is just so important in a, in a business and also multifaceted, you know, there are some excellent insights in this conversation on who should hire a CFO when you should hire a CFO, what that role should look like and what that position should achieve over time. And I think that carries across industries and markets, and it'll be really interesting for our listeners, Speaker 2 00:03:03 For sure, in my interim head of growth roles, I often have the opportunity to interface with CFOs and I've learned just how important and, and vital that role is in growth. So if you're starting to get beyond that stage where finances are more than just administrative and you're thinking about who can help you get to the next level, I think you're gonna find this super interesting, but before we jump in with Tim, we wanna invite our listeners to check out this week's sponsor for the breakout growth podcast and it's SAP they're back. It's, uh, it's great to have them back on board as a sponsor. They are the world's leading provider of enterprise application software, enabling hypergrowth companies to scale quickly to achieve their growth ambitions with their agile cost effective, easy to implement cloud solutions. So if you're working to power, breakout growth success in your business, please check out sap.com/sme. Speaker 3 00:03:56 Yeah, for sure. Thanks. Uh, to SAP for rejoining us as a sponsor. And Sean, I think we should probably just, uh, jump right in with Tim. Speaker 2 00:04:03 Yeah, let's do it. Hi Tim. Welcome to the breakout growth podcast. Speaker 4 00:04:16 Hey Sean. Great to be here. Very excited about the opportunity. Speaker 2 00:04:20 Yeah. We're excited to have you on and I'm, I'm joined by my co-host you Ethan are. Hey Ethan. Speaker 3 00:04:24 Hey Sean. Hey Tim. Good to, good to see both of you. Speaker 4 00:04:27 Nice to meet you, Ethan. Thank Speaker 3 00:04:28 You. Speaker 2 00:04:29 Yeah. So, so most of our listeners are not gonna be familiar with enable injections. So, um, would you be able to give us a, a quick overview of the company and, and maybe a bit about what, uh, the products are that you develop? Speaker 4 00:04:42 Sure. So, uh, enable injections is located in Cincinnati, Ohio. We are, we consider ourselves a bio med tech hybrid and we are actually developing a device to revolutionize medicine. And I'll tell a couple stories and I think, um, it'll resonate. So, um, we actually have a friend who has a teenage son who has Crohn's disease. The mom basically told me that every five to six weeks, they have to pull their son outta school to take him to the infusion clinic. So one of the parents has to take off school. They take the sun to the infusion clinic and they will not prepare the drug for the, uh, infusion until you actually arrive. So the drug gets ordered. You have to sit in this cold dreary infusion clinic next to other sick people, waiting for your, um, drug to show up. In addition to that with a COVID pandemic, you can only imagine, um, they've missed some of their treatments because they, they just didn't wanna be in the hospital. Speaker 4 00:05:58 Also, the sun has a needle phobia, so they, the hospital uses a therapy dog to help with that, which you can imagine the therapy dog sometimes gets double booked, um, shows up late. Um, so the timing of this infusion, you know, the time starts to stack up before they actually get their infusion. Uh, if everything goes, according to plan, the, they show up, they start to give the infusion, but then, you know, they have to find a vein. Sometimes it takes two or three tries, and a lot of times this gets delayed and it gets canceled and they have to reschedule. So they're losing, you know, best case, if everything goes okay, you're talking six, eight hours of their day, every five weeks. And sometimes it's multiple, multiple days. And, uh, they're afraid that their son's not even gonna be able to go away to college. Speaker 4 00:06:57 Um, we believe our device will solve this problem. Uh, a couple more stories, so you can relate my wife's, uh, aunt has rheumatoid arthritis, she's retired, she loves to travel. She has to get an infusion every six weeks, eight weeks. She has to schedule her life around an infusion. And we, we know a patient a two year old boy in West Virginia that has a genetic disorder. His parents have to drive him to Cincinnati, Ohio every week and take two days off work so he can get his infusion. And, um, the, the father ended up losing his job because of it, Speaker 3 00:07:39 It sounds like super, like super impactful. If, if your device is able to solve those problems, I mean, obviously, um, the impact, not, you know, it's not just, I think the time and the, and the, you know, the, the, the disruption, but it's also just like, like if you step back from that, it's the quality of life that you're actually trying to solve for people, which I think is, is incredible and really important. And I think so for our listeners, this is probably a bit of a departure, you know, medical and pharmaceutical, not what we're usually talking about, but I think Sean and I have found that when we go out of our comfort zone and talk to companies that were, are different from what we're, we, we sometimes learn a lot. And I thought what would be really interesting would be to dive into your role as chief financial officer, a lot of startups don't start with a chief financial officer. It comes later, but we really think the chief financial officer role can be really important in growth. So I was, I wanted to find out from you, first of all, do you think like the chief financial officer role, whether you're in pharmaceuticals, whether you're in big tech, whether you're in retail businesses, is there a common thread like that makes them it always important in growth? Speaker 4 00:08:44 Well, it's, it's ironic you bring up this subject because, um, you know, big tech and pharma are, you know, they have deep pockets, right? And, and honestly the, the big tech has a, um, larger balance sheet than the pharmaceutical companies. And mainly because of the time to market and the FDA approvals it, you know, you can, uh, explain a pharmaceutical career, uh, being the time it develops a drug to get to market. So the big tech, they can develop technology quicker. And, um, that's why their balance sheets are, you know, three X compared to the pharmaceutical companies. But if you look at the, you look at these areas, the big tech are starting to come into healthcare because they think they can disrupt the digital technology. You know, the global healthcare, market's gonna be a $15 trillion market by 2030, and you're starting to see apple and Google starting to buy up healthcare companies. Speaker 4 00:09:53 And, uh, we're actually developing a Bluetooth technology, which is gonna be a next gen in our device. It's gonna be a bandaid, uh, smart bandaid. So after you put our device on, you'll remove it and the bandaid will stay on your body and we'll be able to see, are you taking your injector injection? Is it going okay? And then by the way, if you're in the clinic and you go home, the doc can read, you know, some of the biometrics. So this is just unbelievable. And then call you on telemedicine and say, you know, Hey, Sean looks like you're, you're, um, having an infection of flare up, you know, you need to come back to the clinic. So we really think that this is gonna be very impactful. And, uh, we're, we're looking at developing that now. So I think it's exciting where the CFO role really has to, I think, play in the future in both areas. And it's a very high tech, uh, high cost, you know, market. Speaker 2 00:11:01 And so is the, is the CFO role part of it, um, helping to, to lead the efforts on, uh, on, on actual fundraising as well, so that you, you keep those coffers full enough to, uh, to not just manage the cash, but, but, but replenished the cash while you bringing new products market. Speaker 4 00:11:19 For sure. So when I started with enable, it was in 2015, we had 10 people. Um, we raised about 8 million in seed capital. Since I've been with the company we've raised over 400 million in funding, 295 in equity, 35 million in non-dilutive venture debt. And then also 90 million in, uh, pharmaceutical milestones because we'll actually develop the product specific for the drug and the pharmaceutical companies will pay us to develop that device. So it's a very expensive market and environment. And, um, you know, since we are a hybrid type business, we have a lot of areas that a, a pharmaceutical company has in a med tech company has. So we have human factors, we support what the clinical trials and the training. And then we also are designing, developing, and manufacturing a device that's never been out there. There's nothing like it in the world. You know, we can infuse biologics from five ML, 2 25 ML. And, uh, a lot of the, the science, they, they did not even believe that you could do anything over three to five ML. And we have successful clinical trials with people getting infused up to 50 ML. And it's funny because some of them are like, your device is not working. And we're like, yes, you're being infused with the drug. Can you imagine that compared to getting an IV? It's just, I mean, it send children. What, Speaker 2 00:13:03 What is the difference? What is the difference between an IV and an infusion? Speaker 4 00:13:07 So I'll, I'll show you. So here's, here's our device. It's, uh, it's a cute little non-intimidating device. And basically what, what we do is we build the device, um, we'll ship it to the pharmaceutical company, they'll fill a syringe or a vial with their drug. They'll package it together. And that will go to like a Walgreens. The patient will go, they'll pick up their, their drug. They'll put it in the refrigerator when they need to use it. They'll pull it out, they'll put it in the injector, they'll fill it up. When they're done, they pull it outta the injector. They put this on the abdomen, they push the button. A small little needle comes out, goes into your abdomen, and then it will infuse the drug. Exactly. And specifically for that drug, because we build it that way. It's very discreet. People don't even know you're doing it. I could be driving to work. I could be sitting in the office and then there's no lights, there's no button or blender type, uh, communication. Some of the other devices, they have motors. And they're just very loud when it's done, you know, the button pops and you can keep it on your abdomen if you're not available to dispose of it. And then when you're ready, you just peel it off and you put it in the sharps container, or you throw it away. It just has adhesive on the back. Just like the bandaid. Speaker 2 00:14:37 Yeah. Most of our, most of our people are listening and, and not watching, but this is a good excuse to, uh, to highlight our, that, that we do, uh, offer our podcast now on YouTube as well. So anyone who, who wants to see the visuals on there, but I think the, the, the explanation was, was pretty clear for people. So the real trade off then is people, uh, sitting in that clinic for a long time and all the travel time to that clinic versus versus more of a kind of just do it yourself solution now to, to achieve, uh, to achieve results. Is that, is that a, a good shorthand or am I missing something? There Speaker 4 00:15:10 It is. So you're giving people their lives back the, the time to go to the clinic, the, the time to, to get the injection, the pain, to get the injection, you know, and, and we we've coined the term anywhere care. So you can do this in the clinic. You can do it at a Walgreens, you can do it at home. And that is really the value proposition. And then, uh, um, with our additional Bluetooth technology, you can incorporate, uh, the telehealth and, and the doc compliance. So, you know, we found through clinical trials that there's adverse event, uh, few adverse events, um, no injection issues, you know, people prefer our device and just think of the healthcare cost and savings of not having to go to an infusion clinic. Speaker 2 00:16:00 Perfect. Yeah. So, so then one, one last kind of question on the, on the product area is, um, you've talked a lot about the, the clinical trial side of things. So is, is the product commercially available yet, or is it still, still going through clinical trials? Speaker 4 00:16:16 So it is, um, we're, we're close to our first partner submission and we're hoping that we could be approved as soon as next year and on the market. Speaker 2 00:16:28 Okay. So, so then from a running the business perspective, uh, you you've touched on this, but, but it's, it's really a series of milestones and things coming out of, of these clinical trials, uh, that, that essentially have opened the door to, to, to the funding that you've been able to, to bring along the way, but it's a, it is such a different growth story than we're used to in terms of, uh, in terms of like, you know, one Mo most of the time is kind of market risk and not, and not, uh, kind of product viability, risk and approval risk. And so, but I think the CFO role is, is then particularly interesting in that, in that place, cuz you, you really, you really wanna want to be able to direct funds toward moving the process along and, and hopefully have some, some fuel in the tank as you, as you get that approval to be able to really bring it to market. But obviously once, uh, once you get the approval, probably that, that unlocks a whole new set of funds. <laugh> Speaker 4 00:17:24 Well, it's interesting because, um, this business is time and money, right? And you're dealing with pharmaceutical, it's a business to business and we can't control a lot of the timelines and we can't control the FDA. So we have to be able to, um, flex when it's according, um, accordingly. So we either have to tighten the belt or invent that drastically because we're talking millions of devices a year for just one drug. So when we hit the market, we have to take off like a rocket ship. So when we go fundraising, we make sure that we have enough to weather the storms and, um, meet the deadlines and invest to scale this business. You know, we've already invested 60 million in our manufacturing capabilities and we're, we've already invested in semi-automated production lines. And we also invested in, you know, the top of the line systems like SAP. So we're FDA compliant and ready to go when we hit the market. Speaker 2 00:18:30 So the, the production investment, sorry, Ethan. I'm I know you need to hit in there, but the production investments are really interesting one. So that, that is, uh, I, I assume you need some production for the clinical trials, but like super scalable production. Um, you, my, it kind of reminds me of, uh, of in the, in the startup world, there's kind of a famous, uh, story around web van. I don't know if you, uh, ever, ever heard that, but it was, uh, I, I think they had, had invested like upwards of a billion dollars in kind of the infrastructure for a, uh, grocery delivery service that ultimately that ultimately once they launched the, the market demand really wasn't there and they'd put so much into the, into the, uh, into kind of the, the infrastructure around it so that the, um, you know, the, yeah, instead of the, kind of the, you know, that that's led to a more lean approach in the, in the, you know, tech startup world where it's like validate market demand, validate need before market demand. Like in your case, you clearly, you clearly have identified need. And, and so again, it's, it's more, uh, product and approval risk there, but, um, I'm, I'm just, I'm curious on why, why the big manufacturing investment at this stage, Speaker 4 00:19:47 Because when we get approved, we're gonna be launching with millions of units. So, you know, if you have a small clinical line and you're doing 20,000, 30,000, it would be fine, but to scale and do millions of devices, you have to be ready to go. Now at our current location, we'll be able to do 3 million units a year and we'll be able to, to, um, ship out of enable. But when we get to millions, we're going to, uh, bring on contract manufacturing. So we'll have business continuity and also that, uh, that scalability, and we'll be able to replicate our, our automated lines at the contract manufacturer. So we are, we are being wise to make sure that we have enough capacity to, you know, launch right out of enable. But, um, the good thing with these timelines, you know, you can think of by time you engage a pharma to launch, it's usually a four year development cycle, and then it's another four years for manufacturing ramp. So there is time to, to put things in place. Speaker 3 00:20:59 What's interesting to me is when I think about, uh, pharmaceuticals typically, um, you know, uh, a Pharmac, a pharmaceutical company is developing a drug. And I would think that it's sort of top down, they're marketing to doctors and doctors are then saying, oh, this looks like the right solution to a problem for my cus for my, uh, my patient. But in this case, the way you've described this, the real value a doctor prescribe prescribing through this mechanism, I'm sure there's savings and things like that. Or, but the clinics aren't gonna love this. This is how they make their, their money. But my, so my question is, as you go to market is a big push for this going to be, to go directly to consumers in the patients in the world and say, Hey, there's now a better way. You can do this to try to work a bottom up approach, to getting them, to push their doctors, to get, to get them your, your product, or is it, or will follow the more traditional means. Speaker 4 00:21:58 So today, usually through clinical trials, a lot of the patients are demanding products like this. And in addition to that, the payers are pushing home healthcare. So you're already seeing healthcare moving from the infusion clinics to the home because of the savings and payer costs. And then in addition to that, you know, the most, most reasons people don't get better is con of, because of compliance and you add in a pandemic. So this is gonna add a ton of compliance. People are gonna adhere to their medications better. They're gonna get their quality of life back. And the, uh, the payers are gonna win in the long run. And so are the patients. And that's why we've coined the term anywhere care, because we believe that we can create more throughput in the clinic because it doesn't take a chair and it doesn't take a nurse to use our device. You could actually go in the clinic and admin could slap it on. You could go in the coffee shop, come back. The doc could peel it off, say, oh, you look good. You can go home. So if we can create more throughput in the clinic, that's good for the docs and, and everyone around because you're not taking up all that capacity and chair time. And there's a Nur nurse shortages now. And, you know, it's just, healthcare is a, a tough place to be these days. Speaker 3 00:23:28 So it seemed to me as a, as a CFO. You're I think you mentioned this already, but like, your job really is, is about not just thinking about the present, but really about the future steps that are gonna make this successful. Is that, is that accurate? That you're, you're thinking about the marketing of this, even though it's not necessarily time to market this. Speaker 4 00:23:49 Exactly. I, as a CFO, you know, I like to say I have to wear a lot of hats. I I'm wearing the compliance hat, the, the strategic visionary hat, the, uh, business partner to the CFO, the shareholders, and this is unchartered waters for all of us. So understanding the market and how we flex is very important because, you know, it's a $568 billion biologics market. And we like to look at ourselves as an index fund. And each of the drugs are at different phases. Um, in their development, some are already subq. They're just using a pump. Some are IV, they need to convert the subq. And some of them are in phase two or three. So we have to be able to manage this index fund based on key inflection points. And when we think the, the, uh, the pharma partners are gonna hit, and as they start to stack up, then you can really see the value take off, but it does take time and money, as I said, so I have to look, I have to look forward. I have to also build a business that doesn't exist. So I have to hire the right people. I have to build a manufacturing capability. I have to create departments that never ever existed. So it's not an easy role by any means to be doing all of this, you know, it's design develop and create manufacturing capability for a product that's never been out there. Um, plus these areas that, you know, companies have never had before. So this hybrid bio med tech is new for everybody, including the FDA. Speaker 2 00:25:36 This week's breakout growth podcast episode is sponsored by SAP. SAP helps businesses increase productivity and achieve real time transparency with a power and flexibility of SAP cloud solutions. Delivering end to end business transformation. If you have ambitious goals and are working to lead markets and industries, then you probably already know how important it is to align with a technology partner who will scale and drive innovation with future industry leaders like yourself. Don't rely on stitch together solutions that don't talk to each other to manage business finances, operations, HR, suppliers, and customer relationships. Instead leverage the flexibility of SAP's cloud based suite of solutions. You can power all these in one place and gain unprecedented insights into the performance of your business from end to end, whether you are on the brink of, or have already achieved breakout growth, success, learn more by visiting sap.com/sme Speaker 3 00:26:33 Sounds very much like the chaos of breakout growth, like when growth is going fast, it's, it's chaotic. And the, the role is always, the roles are always changing, but I, I guess, um, I work with the company and, uh, we tongue in cheek sometimes refer to the, he's not technically the chief financial officer, but the finance guy as the department of no. Um, and I think, uh, and he's actually very much the department of yes. Um, and really trying to, to make things work. But how do you balance, I mean, you have a limited amount of money. It sounds like you've raised quite a bit, but you have a limited amount of money or, and you're budgeting that money for the future in many as we've talked about. So you're thinking these 3, 4, 5, 10 steps ahead. And right now the money's probably all going in one direction and it's not the one you want. How do you, how do you balance that with the needs of all the individuals and teams in your business asking for, for, for funds to do different things, to, to keep the business moving forward? How do you in your role think about those and make the those decisions? Speaker 4 00:27:37 So we have a very, uh, rigorous budgeting process. And I think getting in front of this early is important. And also I have a team that they're not just accountants and finance people, they're business folks, and they really get in and spend time understanding the business. And, um, so when we get through the budgeting process, there is investment in scaling, but there also is day to day, uh, budgeting for the departments. And then there also is infrastructure growth. What's interesting is we're we only know what we know, right. And we're a very fluid business. So being the CFO, I have to be very flexible in, um, what our budget look like today is probably not what it's gonna look like in a month or two, what we are good at is, um, staying within the dollars in our plan, but flexing on where the priorities are as they come up. And, and that's the key here because, you know, we need to make sure that we keep our runway, um, a, a certain amount to, to get us to profitability and sustainability. And, um, and then the pharma partner milestones are, uh, are gravy on top of that, which just help extend our runway from a non-valid standpoint. Speaker 2 00:29:09 So when, when you're, um, kind of looking at the, at the stage that you're at right now, I, I know any, any time it's in kind of the pharmaceutical space that, that so much of it is this big investment in, in developing something that will work and there's protections around that IP to encourage people to make that investment. Um, and, and I know in, in the, or at least I believe that I've, I've heard that in the, in the just pure drug space, that a lot of, it's a kind of a window of a patent on the back end, um, that, uh, that eventually it kind of becomes some of these things open up to, to generics. And so is that, is that part of the reason too, for, for building that manufacturing capacity, so that as soon as you get that approval, you have that, that window to be able to maximize the opportunity or, or, um, is, am I looking at that wrong? Speaker 4 00:30:01 No, no, you're, you're looking at it correctly. So if you think of our device gets approved with the drug, and usually the patent life is 10 to 15 years. So the contracts are very sticky. Once the pharma partner spends tens of millions of dollars on clinical trials, um, you know, they're sort of married to our product and then, you know, their, their precious drugs are, you know, five to 10 billion drugs. So we have to make sure that they're protected in our device, not only from a device standpoint, but, you know, systematically through traceability and SAP. And, um, so that is, uh, you know, definitely part of it. And also we have exclusivity contract. So if you think of this, there's usually four drugs, um, that do the same thing. And we basically partner with one of the, the three or four pharma companies, and they pay us exclusivity and royalties to help differentiate them. So when you go down to see your doc, he says, okay, Sean, you can have this device and do it at home subq, or you have these three that you're gonna have to go get an IB. So there's the value proposition and the sticky contracts, you know, 10 to 15 years, Speaker 2 00:31:31 Mm-hmm <affirmative>. So you, so you really want to, you wanna be having all of that planning ahead of time and, and, uh, with the, yeah, you have to plan for success. You don't, you don't wanna optimize for, you know, if things don't work, then, then there's not really like a, a, a good exit path. Um, but, uh, so, so in planning for that success, it's, it's really, you're, you're, you're going through a lot of, uh, you know, building that growth engine in anticipation of the, of the day it gets released. And so what, or it gets approved. So one of the things that you had talked about is that there's a, there's a big B2B component there. And so are you talking about with the, the B2B component? Is that more the pharmaceutical partner or is that, uh, or is that, uh, clinics or combination? Speaker 4 00:32:21 So that is the pharmaceutical partner. So we, we partner with a pharmaceutical company on a specific drug or molecule. We build the device specific for that molecule and the pharmaceutical company basically spends all the money on the clinical trials. And then, then we will support with training and then we're partnered together as a combination product. And that's really the business, the business, the beauty of our model is we're not spending money on clinical trials, and we're also accepting the pharma partners, uh, container closure. So a lot of, uh, device companies, they have to invest in filling lines and manufacturing lines for the drug. So they have to bring the drug in. They have to make sure they have the sterile environments. We don't do any of that. We basically ship the device to the pharma company. They marry it to the, their drug. It goes to the Walgreens, the patient goes, picks it up, and then they fill it on their own timeline Speaker 2 00:33:27 On the, on the clinical trial side. Like what, what type of volume are you, are you usually looking at like, is there, is there quite a bit of volume that you need to support there and does that require a lot of marketing behind it? Or is it, uh, is it, is it relatively low volume? Speaker 4 00:33:43 So it depends on the drug. And, and honestly it depends on the phase of the drug. So, you know, if the drug's already approved subq and it's already being administered by a pump, all you have to do is prove our, our device does the same thing. So it could be as small as 20 patients, but the time is still long. It could be a year or two. And then some of the drugs that are, they've just gotten approved. And, um, it's, it's a new drug to the market. The clinicals could be hundreds of thousands of devices over two or three years with, you know, hundreds of thousands of patients as well. So again, it just depends on the drug and some drugs are orphan drugs. Some are high volume drugs, some require fewer patients, but what's in common is time and money. It just seems like the trials take long and, and they cost a lot. Speaker 2 00:34:46 So, and how, how big is the overall team just to get kind of an idea of, uh, like the, the dedicated team, cuz I know that, you know, through partnerships it probably extends quite a bit. Speaker 4 00:34:57 When you say overall team, do you mean, uh, total employees in the company? Speaker 2 00:35:01 Exactly. Yeah. Speaker 4 00:35:03 We have about 200 employees. We roughly have seven partners and um, so we divide our workforce, you know, our BD, our quality, our regulatory, um, between the different partners and then finance, uh, county. It we're pretty lean and mean we have about, uh, 10 or 12 folks. Um, but obviously we're preparing for, uh, you know, long term IPOs. So, uh, you know, that could quadruple overnight and, uh, you know, I've just hired a, a, uh, right hand, uh, senior director because, uh, I need to focus on the innovation and evaluation and not so much the, the day to day. So I'm ready to, uh, work with the bankers, the analyst, and, um, get us ready. Speaker 3 00:35:56 I, I was curious the, the last few years obviously upended the world and you've talked about time as being the, you know, time and money. It would obviously you can't make this get approved any faster. So even though this would've been, I'm sure hugely valuable in the middle of a pandemic when people really couldn't go and sit in the clinic safely. Um, does the fact that we went through that help drive, uh, change in your trajectory? Does it change the, does it accelerate things because there's now a different mindset in the world around the importance of being able to have things like this in your home? Speaker 4 00:36:33 What it has done is made awareness of how important being in the home is because when we were marketing the product before the pandemic, people were sort of like, well, so what at home, but now they can really see the value proposition of, you know, if people don't have to go in the hospital, they can do this at home. Wow. Look at the benefit. In addition to that, it's open the eyes of the FDA. So we're definitely seeing expedited approvals and, um, you know, the timelines are being shortened because they know the value of getting these kind of products added into the market. So it's definitely helped Speaker 3 00:37:13 At this point, have the, the biggest headwinds that you're fighting, have they changed for you over the last few years? Or like, what as CFO? Like what are you, what are the big challenges that you're trying to overcome and have those evolved? Speaker 4 00:37:27 So a lot of the headwinds, you know, are, are somewhat the same. You know, we, we really need to get our first approval. The thing is getting as many pharma partners stacked up. So we have, uh, multiple shots on goal because as you were speaking, you know, if one falls off or there's a drastic change in timeline that we can, uh, adjust the levers and, um, bring in different partners, you know, the, the good thing is, you know, our first approval, we, we believe that, you know, it, we can see the light at the end of the tunnel. Again, you know, the company started in 2010. We thought it was gonna be, uh, a lot quicker than, than it is. So we've learned a lot over the time, but, uh, here we are in 2022. And, um, we see, we see, we see the things starting to stack up. So it's very refreshing. Speaker 2 00:38:22 <laugh>, I'm, I'm, I'm curious if you've been on this journey in other pharma companies or what, what was your sort of, what was your background pre joining this company? Speaker 4 00:38:31 Well, it's, it's, it's funny you bring that up. So Mike Hogan, the founder of enable injections, um, he started a, a company called accure and enable medical back in the nineties. And, uh, Mike actually hired me, um, in the early two thousands to work with him at accure. And, uh, I was part of the IPO process with ature and Aures now a 2.3 billion market cap company, and they, uh, they sell devices to treat atrial fibrillation. So Mike is, uh, very successful and, um, you know, he's just, you know, it's unbelievable, uh, you know, his mindset on coming up with new technologies. Speaker 2 00:39:19 So, and do, do you feel like it's, uh, a specialized skill then to be a CFO in, in managing this process? Because clearly, clearly it's, it's very different when you, when you have to stay really lean, but you need to prepare for that, that big milestone, um, is that, does that take a really unique kind of CFO skill? Speaker 4 00:39:42 It's, it's definitely a unique environment. So if you look at my background, you would find that, you know, I've probably managed almost every function in a company, HR, it supply chain, customer service. I've, uh, I'm a very strong accountant by trade also, self-taught on the finance side, a lot of the fundraising. And, um, so you have to have that breadth of experience, financial modeling business partner, where a lot of companies, they have a CFO with one skill set. They're very strong on an audit compliance standpoint or, and an accounting standpoint, or they're very strong at financial modeling and visionary, but in, in our business, you have to be a Jack of all trades and you have to be able to delegate and you have to be able to flex when it's appropriate. And the hard part is, you know, when we had 10 employees, I was the one setting up the computers and doing QuickBooks and now, um, uh, delegating building teams and, you know, raising value for the business. Speaker 3 00:40:59 So with that breadth of skills, if you were, um, advising, you know, a startup really across any industry, but, uh, like, you know, we, we talked to tech startup, you know, high tech startups all the time. Um, is there, if you, what, at what point would you say it's time to really think about hiring a CFO and what would be the core skills that you think would be really important to look for in that, in hiring that role? Speaker 4 00:41:24 So I think it's really when the tipping point is from the day to day bookkeeping and accounting, to more strategic decision making. So, you know, doing strategic planning, starting to do fundraising, starting to look at building market, share, growing the business. That's really when you need to start looking. And, you know, it depends on the type of business, some need to invest in CFOs sooner, some need to, you know, if you're a widget company and you're pretty mature, you know, you, you probably can get away with a very skilled controller unless you're looking for, um, M and a, or, or growth. And in our case, I was hard early, you know, I was number 10 and, and I was the person building a strategic plan from scratch because we just landed our first pharma partner and we wanted to aggressively start one a new business. So it was not about the day to day bookkeeping. It was really about, you know, how do we, how do we take off? Speaker 3 00:42:34 What do you think CFOs get wrong? Like, or, or what do you think companies get wrong in hiring CFOs? Speaker 4 00:42:41 Well, I think what a lot of CFOs get wrong is they they're, they're very much, um, cut cost, stick to the budget. You know, they don't wanna invest. They, they just wanna, you know, manage the purse strings and what a good CFO needs to realize is when to invest. Because if you get behind the curve, in our case, you're talking a $500 billion market, and if we're not ready to go, you can imagine every day delay on a pharmaceutical drug is millions, millions of dollars. And so we don't want a penny pinch, and we don't wanna save a buck here and there on a head count or a manufacturing line. And that's not easy for a lot of, uh, a lot of CFOs, you know, I invested in, in SAP, um, soon after I started and there'd be a lot of, uh, CFOs that would have a hard time spending, you know, $5 million on SAP. They'd be like, well, let's just wait. Let's just wait. Well, an SAP loves us cuz we're one of the first adopters of SAP, but again, we're a highly regulated FDA environment and we have to be ready to go. When we flip the switch, we don't have time to use QuickBooks and, and then figure it out later. So that's where I think a lot of CFOs get it wrong. They, they just, they struggle on taking risk and investing, um, when it might seem too early. Speaker 2 00:44:21 So it's just that, that optimization for success, but balanced again, having enough against having enough runway to, to ultimately, uh, still, still, still be hanging around when that, when that success comes Speaker 4 00:44:35 Well, the beauty of that is, you know, SAP. If I had to do a big bang approach and invest 5 million out of the gate, there's no way I could do it. So SAP now has a phased approach. I've been implementing SAP for five years now and I'm just bringing on the modules as I need them. And I've been able to spread my cash flow, um, based on different fundraising events. So, you know, it's, it's worked out, um, fantastic, but you have to get creative and you have to know what questions to ask and you, you know, to your point, you have to know where to balance the, uh, the checkbook, because some things probably have to give and then others, you gotta take the risk. Speaker 2 00:45:18 So, so one of the questions that we like to wrap up with is, uh, is usually we ask it as what, what do you understand about growth now that you, that you feel like you didn't understand as well a couple of years ago, but I'm, I'm gonna twist it slightly to, um, looking at, you know, having gone through a journey in the, in the previous to a fantastic, um, what were the things that, from that experience that this time Speaker 4 00:45:49 Are so important. And I think a lot of companies underestimate people in, in our business finding the right people, putting 'em in the right seats, on the bus, making sure that you find the, the strategic visionaries to take you to the next step because getting people aligned and having that vision is so important. And I found in the past, you know, and I've, I've learned that, you know, I was sort of, uh, I struggled with onboarding heads and the cost and, you know, I was like, well, you know, we'll hire the resources when we need 'em. I was more focused on the infrastructure, more so than the people. And, and my I've, you know, I'm all about getting the right people as soon as you can and everything else will fall into place. Speaker 2 00:46:45 Well, so my, my big, uh, my big takeaway from this conversation is really, uh, and then I'd love to hear what, what yours is Ethan. But my big takeaway is really that in kind of the, the type of tech companies that Ethan and I have worked with, uh, where it's, you know, whether it's consumer tech or B2B, but, but it's something where, again, you're, you have an idea, you prototype the idea, you get it into people's hands. It's a very incremental, incremental business where EV as you get that validation, you're, you're, you keep turning up the knobs to drive more and more growth, but it's, uh, as a result like you, you wanna make sure you have scalable systems that, that sort of support you as you go along, but it's, uh, it's, it's a little more of a kind of reactive growth process where I think in, in your case, it's, it's so much of like, just preparing for that day where you, so it's so mission driven. Speaker 2 00:47:37 Yeah. I, I hear so much passion as you talk around about the business and preparing for the day where you can really start to make a big dent in the problem that you're solving. And, uh, and, and just laying that whole foundation. So that in, in one day, you're operating at, at mass scale really quickly. And, and it takes a lot of kind of proactive planning and, uh, and, and, uh, just yeah. Preparation for, for that point. That that's, that's kind of my big takeaway. I don't know if you have any, if, if I'm looking at that maybe a bit wrong, uh, you can give that feedback and then I'd love to hear Ethans as well. Speaker 4 00:48:12 You're absolutely right. Uh, you know, the passion of knowing that you're gonna change someone's life, you know, we've had mothers breaking down, crying saying, when can you get this product to market? My kid can finally go away to college. You know, it's more than a job to me. It's, it's being in an industry that is gonna change the world. And that's what I love about it. So, and I get to do what I enjoy, you know, on the financial aspect. And I love growing businesses. I love wearing a lot of hats. And, um, so, you know, define my home in, in, uh, where I grew up and, and, uh, be able to do it here is, is, uh, fantastic. Speaker 3 00:48:58 So I always love hearing the, the human side, like people who are involved in, in businesses like this, talk about their passion for it, because I think, you know, it's easy. Like, you know, people always talk about, oh, the government does this, or the government does that. I'm like, well, you should meet my brother. He works in the government. I think he's, he's really passionate about what he does. And you'll hear, you know, people will talk about big pharma or, you know, big tech and they may get a sense of, you know, but when I talk to you and I hear what you're saying, again, like to Sean's point, it sounds like at the end of the day, you see a person sitting in a clinic having a better life, if you, if you are successful. And I, I, I really, um, I think Sean and I always believe that companies that are mission driven are the ones that succeed. Speaker 3 00:49:37 So it's, it's, it's neat to hear that in, in this, uh, context as well. But I think one of the things that stuck with me from, from this discussion is just as CFO, you know, again, like, you know, people can, can think of the CFO as, you know, the, the, the nuts and bolts, the bookkeeping, the QuickBook side of the, of the business. But you made this point that really your job is to keep the company ahead of the curve. And it's a lot costlier, uh, to fall behind that any of the cuts you might make to save a few bucks here and there. So I think the penny wise pound foolish, uh, cliche, I mean, it seems like the, the CFO role is all about finding the right person who is willing to take risks and willing to push the business forward. But to do that within the context of like, how do we manage from, from point a to point B, how do we manage to success and to growth? So it was really great stuff. I, I really appreciated it. Speaker 4 00:50:33 And it's about finding the right mentors and people that are great business partners that can bring you along. You know, I've learned a lot from my mentors and, you know, I didn't always have these skill sets. So, you know, finding the right person to help you develop and, and become that, you know, well, rounded person is, is important because, you know, coming out of that, uh, you know, glorified controller type accounting mindset is not an easy one to overcome. <laugh> Speaker 2 00:51:10 Absolutely. Well, it's such an awesome story. Thank you, Tim so much for, you know, taking the time to share how, how you're preparing for growth and, and just, uh, uh, navigating the full process with enable injections. And, uh, we're, we're really looking forward to seeing you, uh, continue on that journey and, and hopefully help a lot of people, uh, through the process. So for everyone tuning in, thank you for listening. Speaker 4 00:51:34 Thank you. Speaker 1 00:51:41 Thanks for listening to the breakout growth podcast. Please take a moment to leave us a review on your favorite podcast platform, and while you're at it subscribe. So you never miss a show until next week.

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