Nuvo Pharmaceuticals Inc. (OTCQX:MRVFF) Q2 2022 Earnings Conference Call August 15, 2022 11:00 AM ET
Company Participants
Jesse Ledger – President and Chief Executive Officer
Mary-Jane Burkett – Vice President and Chief Financial Officer
Conference Call Participants
David Martin – Bloom Burton
Operator
Good morning, ladies and gentlemen, and welcome to the Miravo Healthcare Q2 2022 Results Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct the question and answer session. [Operator Instruction] This call is being recorded on Monday, August 15, 2022.
I would now like to turn the conference over to Jesse Ledger. Please go ahead.
Jesse Ledger
Great. Thank you. Good morning, everyone, and thank you for joining our call today. On the call with me this morning from Miravo is Mary-Jane Burkett, Miravo’s Vice President and 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 urge you to review the cautionary statements and other information contained in the company’s filing on SEDAR, including the company’s Q2 2022 financial statements and MD&A and the annual information form for fiscal 2021, which identifies certain factors and risks 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.
Today’s presentation also includes reference to certain financial measures that do not have a standardized meeting under IFRS. These measures include adjusted total revenue, adjusted EBITDA and cash value of loans. Miravo believes that shareholders, investment analysts and other readers find such measures helpful in understanding Miravo’s financial performance and the company’s Deerfield loans. For a description of how Miravo defines these non-IFRS financial measures as well as the reconciliation of these measures, please refer to Slides 18 and 22 of this presentation, which is posted on the Miravo website as well as Miravo’s management discussion and analysis filed on SEDAR.
The Miravo business boasts a diversified revenue-generating product portfolio. Our three growth assets: the Blexten franchise, Cambia and Suvexx continue to perform well, resulting in a 34% growth in revenue related to these products over the second quarter of 2021. We are continuing to see organic growth of our key promoted brands through market share expansion and have also recently launched or anticipate launching in the near future new products, both in Canada and in international markets. Our scalable commercial infrastructure is ready to accommodate new products, which we are actively pursuing to complement our current business. In May of 2022, a generic version of Pennsaid 2% was approved in the United States and launched at-risk shortly thereafter.
Subsequent to this at-risk generic launch, in August 2022, Miravo’s U.S. partner for Pennsaid 2%, Horizon Therapeutics, announced it would be winding down the business segment that currently promotes and sells Pennsaid 2% in the United States in response to the market erosion resulting from this generic launch. As most of you know, Pennsaid 2% is exclusively manufactured at Miravo’s manufacturing facility in Varennes, Québec. Our U.S. Pennsaid 2% business contributed approximately $1.5 million or 68% and $2.8 million or 70% of total revenue for Miravo’s manufacturing facility during the 3 and 6 months ended June 30, 2022.
Since the at-risk generic launch occurred, Miravo has conducted a thorough evaluation of its manufacturing operations, and we’ve determined that the continued operation of our manufacturing facility is no longer viable as a result of this lost revenue stream. Miravo is exploring strategic alternatives to monetize our manufacturing facility and related intellectual property while winding down our manufacturing operations. Miravo estimates that prior to any recoveries, restructuring charges related to the wind-down of our manufacturing operations will be $2 million to $2.5 million. We anticipate that a wind down of our manufacturing operations may take 9 to 12 months depending on various factors, some of which are beyond our control. We remain committed to enhancing profitability and cash flow generation while advancing our strategic growth objectives.
Exiting our involvement with direct manufacturing will improve our gross profit margins and better focus the company’s efforts and resources on advancing the key growth engines of our business, our commercial business segment and our international licensing and royalty business segments.
Mary-Jane Burkett, Miravo’s Vice President and Chief Financial Officer, will now take you through our financial results for the second quarter of 2022.
Mary-Jane Burkett
Thanks, Jesse. Adjusted total revenue was $23.3 million and $39.1 million for the 3 and 6 months ended June 30, 2022, compared to $19.9 million and $34.5 million for the 3 and 6 months ended June 30, 2021. The $3.4 million increase in adjusted total revenue in the current quarter was attributable to a $2.4 million increase in revenue attributable to the commercial business segment, a $2.3 million increase in adjusted total revenue attributable to the company’s licensing and royalty business segment, offset by a $1.3 million decrease in revenue from the production and service business segment. Revenue attributable to the commercial business segment increased during the 3 months ended June 30, 2022, due to a $3.3 million increase in sales of the company’s promoted products, offset by a $0.8 million decrease in sales of the company’s mature products. Revenue attributable to the commercial business segment increased during the 6 months ended June 30, 2022, due to a $5.5 million increase in sales of the company’s promoted products, slightly offset by a decrease in sales in the segment’s mature products.
The production and service business segment revenue decreased during the 3 and 6 months ended June 30, 2022, primarily due to a decrease in the company’s Pennsaid 2% product sales. For the 3 months ended June 30, 2022, the $2.3 million increase in adjusted total revenue in the licensing and royalty business segment was primarily the result of an increase of a USD 1.8 million Yosprala-related milestone billed to the company’s Japanese licensee. Adjusted EBITDA was $10.3 million for the 3 months ended June 30, 2022, compared to $7.4 million for the comparative quarter. During the 3 months ended June 30, 2022, a $2.1 million increase in gross profit from the commercial business segment and a $2.2 million increase in amounts billed to customers for existing contract assets was offset by a $0.5 million increase in sales and marketing expenses and a $0.8 million decrease in gross profit contribution from the company’s production and services segment. Adjusted EBITDA was $13.4 million for the 6 months ended June 30, 2022, compared to $11.7 million for the 6 months ended June 30, 2021.
During the 6 months ended June 30, 2022, a $3 million increase in gross profit from the commercial business segment and a $2.2 million increase in amounts billed to customers for existing contract assets was offset by a $0.3 million decrease in contribution from the company’s license and royalty business segment and a $1.6 million decrease in contribution from the production and service business segment, a $0.5 million increase in sales and marketing expenses and a $1 million increase in G&A expenses. During the 3 months ended June 30, 2022, the company repaid USD 2.5 million of the amortization loan to Deerfield reducing its cash value of loans outstanding to USD 83.1 million. Since the inception of the Deerfield financing on December 31, 2018, the company has repaid USD 35.4 million towards Deerfield loan. The interest rate for both the amortization loan and convertible loan is a fixed 3.5%. The company anticipates making a USD 2.5 million payment to Deerfield this week.
As at August 11, 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, of which 14.1 million are currently classified as flexible exercise shares. The company’s convertible loan may be converted into common shares of the company at Deerfield’s option at a USD 2.70 per share conversion. Miravo shares closed at $0.68 per share on August 11. The company’s amortization and convertible loans mature and outstanding warrants expire on December 31, 2024.
As at June 30, 2022, the company had cash on hand of $28.6 million with an enterprise value of $86.2 million.
Jesse will now continue with our business update.
Jesse Ledger
Thanks, Mary-Jane. Blexten demonstrated continued year over prior year quarter growth of total prescriptions, or TRx and TRx market share. Blexten Q2 and year-to-date 2022 TRx increased 17% and 18% over the same period in 2021. Blexten Q2 2021 TRx market share increased to 20.9% compared to 18.9% for the comparable quarter in 2021. We expect ongoing year-over-year growth and market share gains in the prescription antihistamine market in the quarters to come. And I’ll remind everyone that Blexten enjoys market exclusivity in Canada through October 2024.
Turning to our second key growth product, Cambia. Cambia’s Q2 and year-to-date 2022 TRx increased 6% and 4% over the comparative period in 2021. Cambia’s Q2 2022 TRx market share was 5.2%, which was consistent with the comparable quarter in 2021. Cambia also benefits from patent protection in Canada through mid-2026.
Our third growth product is the acute migraine treatment, Suvexx. If you recall, Suvexx was commercially launched in Canada in September 2020. So we are now into our second full year of commercial activity. Suvexx’s Q2 and year-to-date 2022 TRx increased 85% and 100% over the comparative periods in 2021. Suvexx’s Q2 2022 TRx market share was 1% compared to 0.5% in the comparable quarter in 2021.
We have a targeted growth strategy that follows two pathways to enhance the value of our business. First, we are focused on the continued organic growth of our existing products, Blexten, Cambia and Suvexx. This will be achieved through disciplined investment in sales and marketing activities that grow our market share in these therapeutic areas. Our Blexten franchise has now achieved a record 20.9% market share as measured by total prescriptions as of the end of Q2 2022, and our number one competitor still controls roughly 50% of this market. There’s significant market share to gain in the coming quarters.
Our second pathway to growth is through inorganic business development opportunities. We are actively seeking to in-license new and innovative products that leverage our existing infrastructure, looking to acquire complementary on-market brands that bolt-on to this commercial infrastructure and to identify and acquire businesses that provide opportunities to realize synergies on integration into our infrastructure. We achieved concrete value drivers in 2022. Earlier this year, we launched Lexin in Pediatric after obtaining Health Canada approval in August of last year. Lexin Pediatric is indicated for the treatment of seasonal allergic riots and chronic spontaneous urticaria in children as young as four years of age and includes two new dosage formats, an oral solution and a quick melt tablet, a quick melt tablet, is a unique offering in the Rx allergy market and differentiates us from our competition by making it easy to administer pediatric formulation available as a prescription alternative.
During the second quarter, we filed U.S. Canadian, European and global PCT patent applications for our reformulated and improved version of results. This new formulation maintains the original claims but is now enhanced with a 100% effectiveness claim for killing nits. Those are the lice eggs in addition to head lice. We believe this enhanced efficacy against nits adds value to existing results partners as well as other companies active in the headlight category globally who may be interested in licensing our technology.
We began the partnering process for this new IP during the second quarter. In June, our European partner, Orion, received marketing authorization for Suvexx packaged in bottles in Denmark, Estonia, Finland, Hungary, Lithuania, Latvia and Sweden with reviews continuing in the remaining 2 markets, Norway and Poland. Orion intends to launch Suvexx in the EU markets throughout 2023, once marketing authorization for a blister pack format has been obtained in each jurisdiction, and we anticipate this will occur before the end of the year. That’s 2022. Suvexx will benefit from 10 years of data exclusivity in connection with the grant of marketing authorization in the European Union.
We continue to be in the process of preparing a resubmission for Pennsaid 2% increase, which is one of the historical markets for original Pennsaid, and look forward to filing this regulatory submission later in the year. This activity will continue even with the planned closure of our manufacturing facility in Varennes. In the second half of the year, we anticipate regulatory approval decisions in Poland, Norway and South Korea for Suvexx. Miravo’s diversified product portfolio, scalable commercial infrastructure and experienced management team provides a strong platform for the next phase of our growth story. The $28.6 million of cash on hand provides us with capital for new business development deals and our quarterly earnings continued to be robust, driven by the growth of our commercial business segment and the new international partnering arrangements.
This ends our formal remarks. We are now pleased to answer questions that you may have with respect to the company, its financial statements and its operations during the quarter and year-to-date.
Question-and-Answer Session
Operator
[Operator Instructions] First question comes from David Martin at Bloom Burton.
David Martin
You and I discussed the transfer of manufacturing of the original Pennsaid to a contract manufacturer. I’m assuming Pennsaid 2% is going to go that way as well. So you can continue to supply Gebro and other potential approvals?
Jesse Ledger
Yes. So we’re in the process right now of working on transitioning manufacturing to other service providers to ensure continued supply of the product to our partners. So that’s work that’s ongoing right now for the two Pennsaid products that are manufactured in our facility today.
David Martin
Is there a chance you would keep manufacturing both of those in your facility and sell the facility to someone who wants to keep manufacturing those along with other products they might bring in? Or is it definitely you’re going to be transferring to another manufacturer?
Jesse Ledger
Yes. The plan is definitely to wind down the operations at the Varennes manufacturing facility. And so whether the products end up at a CMO or a partner or some other outcome, they won’t be manufactured at our facility anymore.
David Martin
So will the facility potentially be sold as a manufacturing facility? Or what will be sold if you can potentially sell it?
Jesse Ledger
Sure. Well, there are a variety of different opportunities that we’re looking at this point. Obviously, the most important thing for us right now is ensuring the consistent supply to our existing partners. So that’s the priority. And then in parallel, of course, we’re looking at what we can monetize from the facility, including the property, the equipment the building itself.
So we’re evaluating all opportunities over the coming months.
Operator
[Operator Instructions] There are no further questions. You may proceed.
Jesse Ledger
Very good. Well, thank you for your questions. Of course, if we are unable to answer a question that you had or you weren’t able to call in or you prefer to reach out to us after the meeting or after the call, please reach out the IR contact information on our website. Thanks, everyone, for listening to our second quarter 2022 earnings call, and thank you for your continued support. Have a great day.
Bye for now.
Operator
Ladies and gentlemen, this concludes your conference call for today. We thank you for participating, and we ask that you please disconnect your lines.
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