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Edited Transcript of MRV.TO earnings conference call or presentation 8-Mar-21 4:00pm GMT

·24 min read

Q4 2020 Nuvo Pharmaceuticals Inc Earnings Call MISSISSAUGA Mar 8, 2021 (Thomson StreetEvents) -- Edited Transcript of Nuvo Pharmaceuticals Inc earnings conference call or presentation Monday, March 8, 2021 at 4:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Jesse F. Ledger Nuvo Pharmaceuticals Inc. - President & CEO * Kelly Demerino Nuvo Pharmaceuticals Inc. - Interim CFO ================================================================================ Conference Call Participants ================================================================================ * David C. Martin Bloom Burton & Co., Research Division - MD & Head of Equity Research ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good morning, ladies and gentlemen, and welcome to the Miravo Healthcare Fourth Quarter Results 2020 Conference Call. (Operator Instructions) This call is being recorded on Monday, March 8, 2021. I'd now like to turn the conference over to Jesse Ledger. Please go ahead. -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [2] -------------------------------------------------------------------------------- Thank you. Good morning, everyone, and thank you for joining our call today. On the call with me this morning from Miravo is Kelly Demerino, Miravo's Interim Chief Financial Officer; and Tina Loucaides, Miravo's Vice President, Secretary and General Counsel. This morning's call makes reference to a presentation on our website that should be viewed concurrently. If you have not downloaded this presentation, I would invite you to do so now by visiting miravohealthcare.com, and scrolling down to the bottom of the page. You can then click on the link. Before we begin, I would like to remind everyone that some of the statements made during this presentation may be considered forward looking. The company cautions investors that results of future operations may differ from those anticipated. We ask you to review the cautionary statements and other information contained in the company's filing on SEDAR, including our annual information form for fiscal 2020, which identifies certain factors that could cause actual results to differ materially from those projected in any forward-looking statements made during the meeting. Copies of the annual information form and other filings are available online. This is our first quarterly call since we rebranded as Miravo Healthcare on December 18, 2020. Miravo consolidates the Nuvo and Aralez brands under one common name. We've not changed our legal name. And for legal purposes, we are recognized as Nuvo Pharmaceuticals Inc., doing business as Miravo Healthcare. The agenda for today's discussion is as follows: I'll provide an overview of the company's investment highlights; Kelly is going to discuss the financial results for the fourth quarter and year, which were announced earlier today, as well as provide a cash and capital structure update. And I will end things off with a business update. Our Commercial Business segment continues to grow organically through the efforts of our commercial sales and marketing team and with the introduction of new products like Suvexx and our 2 new formats of NeoVisc in Canada. Our Licensing and Royalty segment has also expanded, with with recent new license agreements signed for Suvexx in the Nordic Baltic region of Europe and Resultz in the United States. During 2021, we will also begin to see new Manufacturing and Services segment revenues coming from the recent Pennsaid 2% launch in Switzerland and the Resultz launched in Germany. Miravo continues to generate strong revenue and profit returns with cash provided by operating activities of $24 million for the year. This cash flow is not only allowing us to manage our low interest debt facility, but also allows us to fund additional business development opportunities, which will build out our pipeline in the short term and enhance the value of our business long term. 2020 was a challenging year as we learned to navigate the impact of the COVID-19 pandemic on our employees and their families and those we service. We made changes in our approach to business as a result of these restrictions imposed to help stop the spread of COVID-19. Despite the challenges presented by COVID-19, we have continued to realize our business expansion objectives, both domestically and internationally. I anticipate this will continue throughout 2021. Kelly will now take you through our financial results for the fourth quarter and year. -------------------------------------------------------------------------------- Kelly Demerino, Nuvo Pharmaceuticals Inc. - Interim CFO [3] -------------------------------------------------------------------------------- Thanks, Jesse. Today's presentation includes reference to certain financial measures that don't have a standardized meaning under IFRS. These measures include adjusted total revenue and adjusted EBITDA. Nuvo believes that shareholders, investment analysts and other readers find such measures helpful in understanding Nuvo's financial performance. For a description of how Miravo defined these non-IFRS financial measures as well as the reconciliation of these measures, please refer to Slides 29 and 30 of the presentation, which is posted on the Miravo website as well as Miravo's management's discussion and analysis filed on SEDAR. For your reference, Slides 5, 6 and 7 outline the products and the related revenue streams that comprise each of the company's business segments, which are referenced throughout the presentation. Adjusted total revenue was $17.3 million and $71 million for the 3 months and year ended December 31, 2020, compared to $19.6 million and $74.7 million for the comparative period. The $3.7 million decrease in adjusted total revenue in the current year was due to a decrease of $5.4 million of revenue in the Production and Service business segment, combined with a decrease of $2.2 million in the Licensing and Royalty business segment, partially offset by a $3.9 million increase in revenue from the Commercial Business segment. The Commercial Business segment revenue had continued organic growth of its key promoted products, Blexten and Cambia. The decrease in the Licensing and Royalty business segment was primarily due to a reduction of $5 million in the U.S. and rest of world net sales of Vimovo, partially offset by milestone and royalty revenues related to the Yosprala intellectual property in Japan of $3 million. The reduction in the U.S. net sales of Vimovo was due to the launch of a generic version of Vimovo in March 2020, which resulted in the company no longer receiving a guaranteed minimum annual royalty payment of USD 7.5 million, which is USD 1.9 million per quarter from Horizon Therapeutics. The company now receives a royalty of 10% based on U.S. net sales of Vimovo by Horizon and the related authorized generic version sold by Lupin. The Production and Service Business segment revenue decreased as a result of the decrease in the company's Pennsaid 2% product sales. Adjusted EBITDA was $6.2 million and $28.4 million for the 3 months and the year ended December 31, 2020, compared to $8.6 million and $27.2 million for the comparative period. The increase in the current year was primarily due to a decrease in sales and marketing and general and administrative expenses, partially offset by a decrease in gross profit of $4.2 million, which is net of revenue recognized upon recognition of contract assets amounts bill to customers for existing contract assets and inventory step-up expenses. The decline in gross profit was due to a decrease in adjusted total revenue, partially offset by an increase in gross margin percentage on product sales due to the receipt of the Canada Emergency Wage Subsidy and changes in product mix. Gross profit on total revenue was $11.4 million or 66%, and $50.5 million or 68% for the 3 months and year ended December 31, 2020, compared to $13.1 million or 67% and $43.1 million or 62% for the 3 months and year ended December 31, 2019. The increase in gross profit for the current year was primarily due to an increase in license revenue as the U.S. Vimovo royalty stream is no longer considered a contract asset, and gross margin on product sales. The increase in gross margin was the result of the reduction in inventory step-up expense due to the Aralez transaction and changes in product mix. This will be the last quarter in which the inventory step-up expense will have a material impact on our gross margins. As at December 31, 2020, the company had cash on hand of $23.8 million. In January 2020, the company repaid the outstanding balance of the bridge loan, a component of the Deerfield financing, which carried a coupon interest rate of 12.5%. The company's remaining loans, the USD 46.7 million amortization loan and the USD 52.5 million convertible loan each carry a coupon interest rate of 3.5%. During 2020, the company repaid $22.4 million, which is USD 16.8 million of debt in accordance with the Deerfield financing agreement and associated amendment. In our financial statements are required to report our amortization and convertible loan value as well as the interest payable in accordance with IFRS standards. This next slide provides a reconciliation between the IFRS accounting value under the amortized cost method of our outstanding debt compared to the actual cash value of the debt. As at December 31, 2020, the cash value, which represents the remaining principal payments of the amortization loan and convertible loan was $59.4 million and $66.8 million, respectively, or USD 46.7 million and USD 52.5 million. Since November 2019, we've repaid 29% of the original combined value of the USD 6 million bridge loan, which is now entirely repaid and the USD 60 million amortization loan. The USD 52.5 million convertible loan remains outstanding and is not prepayable. As of December 31, 2020, the company has repaid the outstanding balance of the bridge loan in the amount of $4.5 million and paid $17.9 million towards the amortization loan, or USD 3.5 million and USD 13.3 million, respectively. As at March 5, the company had 11.4 million shares outstanding. Attached to the company's amortization loan are 25.6 million warrants issued to Deerfield at a CAD 3.53 strike price. The company's convertible loan may be converted into common shares of the company at Deerfield's option at USD 2.7 per share conversion. Miravo shares closed at $1.71 a share on March 5. The company's amortization loans and convertible loans mature and outstanding warrants expire on December 31, 2024. Jesse will now continue with our business update. -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [4] -------------------------------------------------------------------------------- Thanks, Kelly. Our growth strategy is driven by 5 key elements: first, we are focused on the continued organic growth of our existing products and targeted in-licensing or acquisition of accretive growth-oriented products, which leverage the company's in-house commercial, scientific and manufacturing infrastructure. Second, we plan to further expand our Canadian business with the commercial launch of new products like Suvexx, which launched in September, and 2 new line extensions of NeoVisc launched in early January of this year. Third, our international business continues to grow through our license and distribution partnerships worldwide. We remain focused on business development activities, and we'll continue to evaluate new and synergistic opportunities. Fourth, our manufacturing facility in Varennes, Québec has developed and will continue to refine processes to enhance the quality and efficiency of manufacturing operations. And finally, the company holds over 100 patents globally and has several patent applications pending. We continue to develop a strong patent portfolio to protect our products. Suvexx is our prescription medication indicated for the acute treatment of migraine attacks with or without aura in adults. We launched this innovative and clinically differentiated treatment for acute migraine in the approximately $130 million Canadian acute migraine treatment market in September of last year. As a result of the COVID pandemic, we were forced into a virtual launch. To date, the Suvexx launch has been well received with very positive feedback from both physicians and patients, who now have access to this new and innovative medicine. Our experience from virtual sales rep activities for Blexten and Cambia, which have been in place since March 2020, are certainly making our virtual launch much easier to manage. We continue to advance our product pipeline towards commercialization. We filed the Blexten Pediatric registration dossier with Health Canada in June of last year, and the dossier was accepted for review in October with an anticipated regulatory decision by late summer 2021. Blexten Pediatric is anticipated to be indicated for the treatment of seasonal allergic rhinitis and chronic spontaneous urticaria in children and will help to further strengthen our relationships with allergists, dermatologists and primary care physicians, who treat allergy and urticaria patients. NeoVisc is an injectable viscosupplement used to replenish the synovial fluid in the joint patients with osteoarthritis. 2 new SKUs of NeoVisc were issued a medical device licensed by Health Canada in September 2020, and were commercially launched in Canada in January 2021. The line extensions include a low volume single injection presentation called NeoVisc One and a new triple injection presentation called NeoVisc+. Our orthopedics and sports medicine focused sales force is now actively promoting and selling NeoVisc across Canada. Our key growth assets, Blexten and Cambia, have continued to perform as expected during the fourth quarter in spite of COVID-19 impacts. Blexten's fourth quarter performance reflects the traditional seasonal decline in the oral antihistamine market at the end of the year as colder weather reduces seasonal allergens. Blexten demonstrated continued year-over-year growth of total prescriptions or TRx and TRx market share during the quarter. Blexten's Q4 and full year 2020 TRx increased 28% and 35% over the same periods in 2019. Blexten's Q4 2020 TRx market share increased to 16.2% compared to 13.6% for the comparable period in 2019. Blexten continues to capture the market share of our #1 competitor, cetirizine or reactant. Our sales force is doing an excellent job of expanding the prescriber base for Blexten, and we expect ongoing year-over-year growth and market share gains in the prescription antihistamine market in the quarters to come. Blexten will enjoy market exclusivity in Canada through October 2024. Turning to our second key growth product, Cambia, an innovative prescription treatment for acute migraine. Cambia, which is the only prescription NSAID, approved in Canada to treat acute migraine, acts fast and begins to work in as little as 15 minutes. Cambia's Q4 and full year 2020 TRx increased 16% and 17% over the comparative periods in 2019. Cambia Q4 2020 TRx market share increased to 5% compared to 4.4% in the comparable quarter in 2019. We anticipate continued prescription growth of Cambia, consistent with historical trends, and Cambia will also benefit from patent protection in Canada through mid-2026. In February 2021, Miravo Ireland entered into an exclusive license and supply agreement with The Mentholatum Company for the exclusive right to commercialize the results formula and technology in the United States under the Mentholatum brand. The Mentholatum Company will manage all U.S.-specific commercial activities, and Miravo Ireland will earn revenue from The Mentholatum Company pursuant to the supply of finished product under the license agreement. It is anticipated that The Mentholatum Company will launch results during the summer of 2021, which is the typical peak head lice season. Resultz is currently manufactured by our contract manufacturing partner in Europe. We are excited to partner with The Mentholatum Company and to leverage the brand equity they have developed in the Mentholatum brand over the past 100 years. The Mentholatum Company has launched many successful national brands, including Mentholatum rub, OXY skin care products, Softlips lip care products and other brands in a variety of consumer health categories. The licensee for Pennsaid 2% in Switzerland, Gebro Pharma, launched the product in early January. Resultz, branded as Lausbub in Germany, was launched in this important market in October 2020. This launch is in the early days now, but we are encouraged by the significant effort put into the commercial launch effort by our partner, Heumann, including social media, e-commerce and full online infrastructure to provide parents with the information they need to use Resultz and to treat their children's head lice infestations. Miravo will earn royalty revenue from each of these partnerships. These commercial launches are also anticipated to have a positive impact on our production and service business segment as our partners grow their market share and place follow-on orders for finished product supply. Our manufacturing facility in Varennes, Québec is producing the finished Pennsaid 2% product for Switzerland. Manufacturing for our Resultz business in Europe and the upcoming U.S. launch is handled by our European-based contract manufacturing partner. Miravo earns revenue on the supply of finished product to our partners for Pennsaid 2% and Resultz. In December 2020, Miravo Ireland entered into an exclusive license and supply agreement for Suvexx with Orion Corporation for select European Union markets, primarily in the Nordic and Baltic regions. Orion will be responsible for obtaining and maintaining the marketing authorizations for Suvexx, and will also manage commercial activities for the EU markets covered under the agreement. Miravo will earn royalties on net sales of Suvexx in the Orion territories, starting in 2022, subject to regulatory approval. Miravo and our partner, Orion, anticipate that Suvexx will enjoy at least 10 years of market exclusivity in the Orion territories upon approval. We've achieved some important milestones during the fourth quarter and during the first 2 months of 2021 as we continue to meet our growth strategy objectives. While our business has had to adjust the way we operate in order to deal with the COVID pandemic, this adjustment has not slowed us down from completing the value-creating activities we set out to accomplish. In addition, we are hard at work bringing new products and opportunities to our pipeline through targeted business and commercial development opportunities. That ends our formal remarks. And before I open the floor for questions, I'd like to take a moment to recognize and thank Kelly for the amazing job she has done over the course of last year as our Interim CFO. Kelly, over the last 12 months, we have experienced unprecedented challenges as a result of COVID-19. Throughout this entire period, you've not missed a beat, you took on all the challenges headfirst, you persevered and you succeeded. You've been a key part of our success in 2020, and I want to thank you again for a job well done. I also look forward to welcoming back Mary-Jane Burkett from her maternity leave, for the next quarterly earnings call later this spring. Mary-Jane's timing for having her baby was impeccable, and it will be great to welcome her back into the fold. We are now pleased to answer questions that you may have with respect to the company, its financial results and its operations. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Your first question comes from David Martin from Bloom Burton. -------------------------------------------------------------------------------- David C. Martin, Bloom Burton & Co., Research Division - MD & Head of Equity Research [2] -------------------------------------------------------------------------------- A couple of questions. First one, your international product sales and international license revenue exceeded our forecast by a fairly wide amount. I'm wondering were there stocking shipments to Heumann or Gebro during the fourth quarter? -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [3] -------------------------------------------------------------------------------- No, there weren't. The Heumann stocking order was earlier in the year, and Gebro was -- there was -- it was in the third quarter. So... -------------------------------------------------------------------------------- Kelly Demerino, Nuvo Pharmaceuticals Inc. - Interim CFO [4] -------------------------------------------------------------------------------- And they're both for Q4. -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [5] -------------------------------------------------------------------------------- Yes. I guess just as you know, Dave, our Production and Service revenue on a quarter-by-quarter basis is somewhat lumpy, just sometimes it's just the timing of when shipments go out, especially when it comes to some of the international business for original Pennsaid and shipments decrease in Italy and even in Canada. But -- so I think it's just our typical lumpiness. -------------------------------------------------------------------------------- David C. Martin, Bloom Burton & Co., Research Division - MD & Head of Equity Research [6] -------------------------------------------------------------------------------- Okay. On the flip side of things, the U.S. Pennsaid revenues were down sequentially, but you had a very strong Q3. I think Horizon may be stocked up then. Where do you expect these U.S. Pennsaid revenues to level out? And is the expected trajectory still moderately down or has Voltaren Gel going OTC created a situation in which you can maybe get Pennsaid 2% to start growing again in the U.S.? -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [7] -------------------------------------------------------------------------------- Good question. And I think when we look at the prescription trends that we see for Pennsaid 2% in the U.S., it's pretty much stabilized over the course of the year. And I know you've got a Bloomberg terminal. So you can see that data, and you guys publish that on a regular basis. It's been pretty flat. And so really, obviously, Horizon has their own strategies in terms of supply chain management and the connection between prescriptions and what we manufacture and supply. There's a bit of a gap there. But I think our perspective is that, that business has stabilized. And that there -- we're not really seeing an impact, at least from a prescription and a demand standpoint, as a result of OTC, which has actually also gone generic. And so I think the business, from our perspective, has stabilized. But of course, we're always at the whim of Horizon supply chain management, and that's something that we've got limited visibility and control over. -------------------------------------------------------------------------------- David C. Martin, Bloom Burton & Co., Research Division - MD & Head of Equity Research [8] -------------------------------------------------------------------------------- Okay. Do you see with Voltaren Gel going OTC an opportunity to actually grow prescriptions of Pennsaid 2%, though? -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [9] -------------------------------------------------------------------------------- Ultimately, that's a question for Horizon. They obviously control the commercial, the sales and marketing opportunities. And it would seem on the surface like an opportunity to take advantage, but they've obviously got their own priorities in terms of what they're focusing their time and effort on. -------------------------------------------------------------------------------- David C. Martin, Bloom Burton & Co., Research Division - MD & Head of Equity Research [10] -------------------------------------------------------------------------------- All right. Blexten and Cambia scripts were pretty much in line with our forecast, but you beat on the revenues from those 2 products. So I'm wondering was there stocking up in the channel in the quarter? -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [11] -------------------------------------------------------------------------------- In the fourth quarter, so we did take a price increase at the end of the year, which we typically do, which could have resulted in a bit of forward buying as the wholesalers take advantage of buying some lower-priced products before the price increase is implemented. So that was likely part of that, but -- and otherwise, we didn't really see any other sort of rush on demand like we saw in the first quarter of the year. And I think one of the things that we saw as the year sort of progressed was -- you saw the tremendous demand in Q1, you saw the world in Q2 sort of go into lockdown with the uncertainty of COVID and so demand waned. And then the summertime, the world kind of went to normal -- back to normal, but I don't know how many patients went to see doctors. And then in the final quarter of the year or the fall and the early winter, things started to come back to normal. So it was a bit of a wonky year from a timing of revenue standpoint. But certainly, the price increase at the end of the year always has some impact on driving additional wholesaler and pharmacy demand. -------------------------------------------------------------------------------- David C. Martin, Bloom Burton & Co., Research Division - MD & Head of Equity Research [12] -------------------------------------------------------------------------------- Okay. U.S. license revenue ticked up, but despite the genericization of Vimovo. I'm wondering, was there any shipment of Resultz to Mentholatum or was this just Vimovo? And if it's just Vimovo, was that a temporary blip or are there reasons to believe your Vimovo revenues might stabilize here or start to move up? -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [13] -------------------------------------------------------------------------------- Yes. There was not a shipment for Mentholatum that we'd be expecting to ship some product in 2021 in anticipation of that commercial launch in the summer. We did see slightly stronger results on Vimovo and the authorized generic in the U.S. I think all I can say is that the one generic, the Dr. Reddy's generic really has not been sort of performing as we would have expected in terms of their ability to take market share. And as a result, the authorized generic, which is sold by Lupin and the Horizon brand product, Vimovo, are performing better than we would have anticipated. It's very difficult to sort of predict what might happen with that business. And if Dr. Reddy's decides to change their strategy or do something different where they can take more market share, it's -- that part of the business is definitely performing better than we would have anticipated. But if I had to take a guess of what would happen moving forward is that the generic business will continue to erode market share from the brand and the authorized generic. And I would be expecting the revenue to continue to decrease. But again, you never know what happens with the strategies that the generic companies are taking, and Dr. Reddy's, in this case, certainly has not performed the way that we would have anticipated. -------------------------------------------------------------------------------- David C. Martin, Bloom Burton & Co., Research Division - MD & Head of Equity Research [14] -------------------------------------------------------------------------------- Are they short on supply or is supply not an issue and it's just they haven't been able to sell what they have? -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [15] -------------------------------------------------------------------------------- I can't really comment on that. I don't have visibility into Dr. Reddy's supply chain. There certainly hasn't been anything that's been put out into the public domain. So I'm not sure what is causing their inability to take market share. -------------------------------------------------------------------------------- David C. Martin, Bloom Burton & Co., Research Division - MD & Head of Equity Research [16] -------------------------------------------------------------------------------- Okay. And my last question. You're going to be selling more Resultz, I'm wondering what's your thoughts as far as bringing the manufacturing in-house? -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [17] -------------------------------------------------------------------------------- Yes. So it's one of those things that we're still working on. Obviously, when you're -- I suppose, one of the benefits of having a contract manufacturer that's ready and able to produce the product is that there's no gap in the supply chain in terms of being able to launch in a relatively short period of time. And that's what's happening with the U.S. business. We've got a pretty short-term window to get the launch out this summer. And so the anticipation or the expectation is that in the future, we would bring that production in-house. The timing right now is being worked on. We do have the ability to manufacture results in-house. But obviously, before we can do that for the U.S., there's certain data, technical data, stability data, things like that, that would need to be generated. And so in order to accelerate the time line for getting the product on the market, take advantage of the remaining patent life and to start establishing market and brand equity, we felt in discussions with Mentholatum that it would make sense to proceed with the existing contract manufacturer and then work at bringing in an alternate site at an appropriate time in the near future, which obviously would be our manufacturing facility in Varennes. -------------------------------------------------------------------------------- Operator [18] -------------------------------------------------------------------------------- (Operator Instructions) Okay. It appears there's no further questions at this time. Please proceed. -------------------------------------------------------------------------------- Jesse F. Ledger, Nuvo Pharmaceuticals Inc. - President & CEO [19] -------------------------------------------------------------------------------- Okay. Well, as always, thanks, everyone, for listening in, participating and appreciate your continued support for what we're doing and look forward to talking about Q1 in a few months' time. So take care. Thank you. -------------------------------------------------------------------------------- Operator [20] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.