Cipher Pharmaceuticals Inc. (CPH) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the Cipher Pharmaceuticals Quarterly Conference Call for the company's Full Year and Q4 2024 results. [Operator Instructions] As a reminder, this conference call is being recorded today, Wednesday, March 19, 2025. On behalf of the speakers that follow, listeners are cautioned that today's presentation and the responses to questions may contain forward-looking statements within the meaning of the safe harbor provisions of the Canadian provincial securities laws. Forward-looking statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are implied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. For additional information about factors that could cause results to vary, please refer to the risks identified in the company's annual information form and other filings with Canadian regulatory authorities. Except as required by Canadian securities laws, the company does not undertake to update any forward-looking statements. Such statements speak only as of the date made. I would now like to turn the call over to Mr. Craig Mull, Interim Chief Executive Officer of the company. Please go ahead, Mr. Mull.

Good morning, everyone, and thank you for joining us today. Before I begin, I would like to remind everyone that all figures discussed on today's call are based in U.S. dollars, unless otherwise specified. I would first like to provide an update on Cipher's base business comprising of product revenue in Canada and licensing revenue in the U.S. Revenue from the base business for the year ended December 31, 2024, came in higher than in 2023. Product revenue in 2024, led by sales of Epuris was $2.1 million or 17% higher than the prior year. However, licensing revenue had a mostly offsetting effect, whereby licensing revenue in 2024, largely driven by the Absorica portfolio was $1.9 million or 22% lower than prior year. Epuris in Canada is the isotretinoin market leader and continues to gain market share, whereas Absorica in the U.S. competes in a highly competitive genericized market. Further, product shipments of Absorica to our partner on which Cipher earns revenue were lower in 2024 than in 2023.  Licensing revenues from Absorica for the second half of 2024 were also impacted by a contractual royalty rate decline. Overall, our base business continues to be a reliable source of cash flow. Next, I will provide an update on our Natroba business in the U.S., which now forms a substantial portion of our overall business and provides a platform for further growth for Cipher. We acquired the Natroba business from the former owner, ParaPRO, at the end of July 2024. Natroba business is comprised of the global product rights for Natroba, its authorized generic Spinosad and the U.S.-based commercial infrastructure headquartered in Carmel, Indiana. During the approximately 5 months of 2024, where we own the Natroba business, the business delivered meaningful additional revenue and earnings for the company. We believe the business also provides growth potential with respect to its existing products, Natroba and the authorized generic Spinosad and as a platform for future growth in the U.S. market. Since acquiring the Natroba business, we have been focusing our efforts on integrating the business with our existing team, developing strategies such as the recent expanded indication of the product in the treatment of scabies in the U.S. market as well as exploring and pursuing opportunities to bring Natroba to other markets outside of the U.S., which I will touch on later in my remarks. Integration activities for the Natroba business included executing on plans to directly commercialize the product entirely and winding down a co-promotion partner contract historically in place in certain regions in the U.S. In doing so, we are now benefiting from streamlined efficient selling costs for the product, but also, we are benefiting from the reduced distribution costs where the former co-promotion partner additionally earned a fee. This transition was completed at the end of 2024. And in 2025, Cipher is now selling and distributing directly across the United States. We are very excited about our growth potential moving forward, including expanding our market share in the indication of scabies, which was a key strategic objective of the business acquisition. As we indicated in our third quarter earnings call, the co-promotion partner transition had a near-term temporary impact on lower sales and earnings in comparison to historical sales and from our expectations for the business towards the end of 2024. However, I'm happy to announce the transition is now complete. Entering 2025, our U.S. Natroba business is positioned to benefit strongly from this initiative with our commercial efforts directly under our control as well as in positioning the business to grow sales, expand margins and deliver strong earnings in the future. Additionally, we continue to believe the infrastructure we acquired in the Natroba acquisition provides Cipher with a strong platform to expand upon for our U.S. business. There are opportunities to cross-pollinate our existing portfolio of products as well as to in-license new products that fit well into our expertise in dermatology and infectious diseases. Cipher's business strategy includes both organic growth through increasing sales of Natroba for the scabies indication as well as inorganic growth through further acquisitions, and we intend to acquire complementary dermatology products to add to our combined North American platform. Accordingly, in addition to a focus on growth of Natroba, we are also putting significant focus into our efforts on pursuing other strategic business development opportunities, including acquiring or in-licensing products that are complementary to our existing portfolio and company acquisitions that are either accretive or that have a specific strategic purpose. Our Chief Business Officer, who joined us in October of 2024, is focused on identifying, evaluating and pursuing various business development opportunities to provide additional avenues of growth to Cipher. Since October, we've evaluated over 30 in-licensing and acquisition opportunities, and we are in active discussions with several of those parties. As I mentioned earlier in my remarks, Cipher is pursuing opportunities for Natroba outside of the U.S. market, which includes directly marketing and distributing the product in Canada as well as out-licensing the product to partners in markets outside of North America. Cipher is currently in the process of preparing submissions to Health Canada for approval of Natroba in Canada, a natural step in our growth of the Natroba brand given Cipher's existing footprint in the Canadian market with its business -- with its base business. We are targeting the second quarter of 2025 for a pre-meeting with Health Canada related to our new drug submission. In bringing Natroba to Canada, we are able to leverage our Canadian sales strategy. Natroba will fit well with our dermatology product portfolio in Canada, including Epuris, the Canadian market leader for the treatment of severe acne. We have established relationships in dermatology in Canada, which we believe will be a natural fit for Natroba. We will continue to provide updates on Natroba in Canada as developments occur. In terms of opportunities for Natroba globally, we currently have ongoing out-licensing discussions with 8 parties that are interested in Natroba in different territories. Natroba is particularly well suited in warm climate regions where there is a high unmet need for a highly effective product like Natroba to address licensed scabies indications. Similar to Natroba in Canada, we will continue to provide updates on growth for Natroba globally as developments occur. The final item I would like to comment on is in respect to the company's share price. We believe the current price of Cipher's common shares do not fully reflect their inherent value. Accordingly, the company intends to file with the Toronto Stock Exchange a notice of its intention to commence a normal course issuer bid or NCIB. Cipher also intends to utilize block purchases in addition to the daily repurchases under the NCIB to repurchase its common shares. We believe that share repurchases at the present pricing levels are an effective allocation of our capital and provides value to our shareholders. We will continue to balance the need for growth capital with returns of capital to our shareholders as we have demonstrated previously. Repurchases of Cipher's common shares are expected to begin immediately. Following, firstly, the successful approval by the TSE of Cipher's notice of intention to commence an NCIB; and secondly, the company being permitted to do so following the expiry of any blackout periods in effect due to customary regulatory restrictions. We will provide an update on this item by way of a press release once Cipher has filed its application for approval of the NCIB with the TSE. To wrap up my commentary, I briefly summarized the main items. Our base business was steady and ahead of prior year. And despite a decline in licensing revenue in the U.S., the Epuris product revenue in Canada experienced growth, and our base business continues to be a reliable source of cash flow. We have put significant focus on integration activities and identifying efficiencies within the Natroba business, which positions us strongly entering 2025. We are also advancing our pipeline of opportunities to both organically and inorganically build our North American platform comprised of the existing Canadian business and then the Natroba business in the U.S. We do not expect a significant impact on our business at this time from tariffs and trade policies. However, we're continuing to monitor developments. Finally, as our shareholders expect, we will continue to make wise choices in capital allocation. And as such, we intend to file with the Toronto Stock Exchange a notice of intention to commence an NCIB as well as intend to utilize block purchases to repurchase larger quantities of common shares. I thank you for your time this morning and look forward to answering your questions after our prepared remarks. I will now pass the call over to our CFO, Ryan Mailling, for an overview of our financial results. Ryan, please go ahead.

Thank you, Craig, and good morning, everyone. As a reminder, all amounts provided during this call are in U.S. dollars, unless otherwise noted. Today, Cipher Pharmaceuticals is reporting results from the company's fourth quarter of 2024 being the 3-month period ended December 31 -- full fiscal year. I will first discuss the highlights from our fourth quarter results, then turn my comments to our 2024 annual results. Highlights from our fourth quarter include, total net revenue for the fourth quarter of 2024 was $11.8 million, which represents an increase of $6.9 million or 141% compared to the same quarter in the prior year. This increase was attributable to an increase in product revenue, partially offset by a slight decline in licensing revenue. Product revenue was $10.5 million for the fourth quarter of 2024 compared to $3.4 million in the prior year. This represents an increase of $7.1 million or 209% compared to the same period in the prior year. Contributing to this increase in product revenue for the fourth quarter of 2024 was revenue of $6.5 million from Natroba in its authorized generic Spinosad, which Cipher acquired the global product rights for during the third quarter of 2024. Additionally, product revenue from Epuris in Canada was $3.5 million for the fourth quarter of 2024, an increase of $600,000 or 21% compared to $2.9 million during the same period in the prior year. In constant currency, product revenue from Epuris in the fourth quarter of 2024 increased by $700,000 or 27% compared to the same period in the prior year. Market share for Epuris has increased by 2.7% to 47.7% at December 31, 2024, up from 45% market share at December 31, 2023, according to IQVIA market data, contributing to an overall increase in sales volumes. Overall, licensing revenue was $1.4 million for the fourth quarter of 2024, which decreased by $0.1 million or 7% compared to $1.5 million in the prior year. Licensing revenue from the Absorica portfolio in the U.S. was $900,000 in the fourth quarter of 2024, representing a decrease of $100,000 or 10% for the quarter compared to the same period in 2023. This decrease in Absorica licensing revenue was primarily attributable to lower net sales earned on the products by Cipher's distribution partner on which Cipher earns a net sales royalty, combined with a contractual reduction in royalty rates on the Absorica portfolio, which began in the third quarter of 2024. Market share for the overall Absorica portfolio has decreased by 0.9% to 6% as of December 31, 2024, compared to 6.9% market share at December 31, 2023, according to Symphony Health market data. We have experienced an increase in gross margin on product revenue of 5% to 77% gross margin for the fourth quarter of 2024, excluding noncash fair value adjustments on acquired inventory in connection with the acquisition of the Natroba business. This increase in gross margin is in comparison to 72% for the same period in the prior year due to Natroba and Spinosad authorized generic products, which had a combined gross margin of 81% in the fourth quarter of 2024. Selling, general and administrative expenses were $5.7 million for the fourth quarter of 2024, an increase of $4.4 million for the same period in the prior year. The increase is primarily attributable to the Natroba business, including acquisition, restructuring, and other costs incurred in connection with the acquisition of this business as well as incremental operating costs associated with the ongoing operations of the acquired business. Also included within acquisition, restructuring, and other costs during the fourth quarter of 2024 were transition costs associated with the contractual windup from a co-promotion and distribution partner in the Natroba business as previously described in Craig's remarks. Further, contributing to the increase in selling, general and administrative expenses for the fourth quarter of 2024 was $900,000 legal costs incurred as part of the company's base business in connection with the contractual arbitration process commenced by Cipher. I would also like to highlight an item in connection with the acquisition of the Natroba business, which impacts our reported financial results and gross profits for 2024. Accounting standards surrounding accounting for the acquisitions that involve inventory require that fair value adjustments be made. By applying these required accounting standards, it has resulted in a $2.7 million noncash adjustment to cost of products sold, which had an impact on our financial results for the fourth quarter and full year of 2024, including, but not limited to, the cost of products sold, gross profit, net income and earnings per share. Additionally, as this is a noncash required accounting treatment, it has been included as an adjustment to reconcile net income to adjusted EBITDA. Adjusted EBITDA for the fourth quarter of 2024 was $5 million compared to $2.9 million for the comparable period in 2023. The increase in adjusted EBITDA of 73% was largely attributable to the addition of the Natroba business during 2024, partially offset by legal costs incurred in the company's base business, as previously mentioned. Our business generated $8.3 million in cash during the fourth quarter of 2024, ending the quarter with $17.8 million in cash on hand. In addition to continued strong cash flows from our base business, the Natroba business has contributed to additional operating cash flows during the fourth quarter of 2024. I will now turn your attention to our results for the full year of 2024. Total net revenue for the full year of 2024 was $33.4 million, which represents an increase of $12.2 million or 58% compared to 2023. Revenue in 2024 increased as a result of additions to our product revenue portfolio as well as revenue growth from existing products, which was partially offset by a decline in licensing revenue. Product revenue was $26.7 million for the year ended December 31, 2024, compared to $12.7 million in the prior year. This represents an increase of $14 million or 111% compared to 2023. Contributing to this increase in product revenue for the year ended December 31, 2024, was revenue of $12 million from Natroba and its authorized generic Spinosad. Additionally, product revenue from Epuris in Canada was $13 million for the year ended December 31, 2024, an increase of $2.2 million or 20% compared to $10.8 million in the prior year. The increase in revenue from Epuris was attributable to higher sales volumes and on a constant currency basis, Epuris grew by 22%. Overall licensing revenue was $6.6 million for the year ended December 31, 2024, which decreased by $1.9 million or 22% compared to $8.5 million in the prior year. Licensing revenue from the Absorica portfolio in the U.S. was $4.5 million for the year ended December 31, 2024, representing a decrease of $1.6 million compared to the year ended December 31, 2023. This decrease in Absorica licensing revenue was primarily attributable to greater generic competition experienced in the U.S. market and lower product shipments in 2024 compared to 2023. The company earns revenue from supplying product to its distribution partner, of which the volume and value of these shipments was higher in 2023 due to additional demand for the product in the third quarter of 2023. Also contributing to the reduced licensing revenue from the Absorica portfolio in 2024 were lower net sales realized by Cipher's distribution partner on which Cipher earns a net sales royalty. This was also combined with a contractual reduction in royalty rates on the Absorica portfolio effective the beginning of the third quarter of 2024. Licensing revenue from Lipofen and Lipofen authorized generic was $2 million for the year ended December 31, 2024, compared to $2.2 million in 2023. The decrease of $200,000 or 10% during 2024 was due to lower sales volumes and net sales realized by Cipher's distribution partner on these products on which the company earns a royalty. Gross margin on our product revenue, excluding noncash fair value adjustments on acquired inventory in connection with the acquisition of the Natroba business has increased by 8% to 76% gross margin for 2024 compared to 68% in the prior year. The gross margin increase results from the addition of the Natroba and Spinosad authorized generic products during 2024, which had a combined gross margin of 83% in 2024. Selling, general and administrative expenses was $15 million for the year ended December 31, 2024, an increase of $9.3 million compared to $5.7 million in the prior year. The increase is primarily attributable to the Natroba business, including acquisition, restructuring and other costs incurred in connection with the acquisition of this business as well as incremental operating costs associated with the ongoing operations of the acquired business, which includes salaries and benefits costs for the team of sales representatives. Also included within acquisition, restructuring and other costs for the year ended December 31, 2024, were costs associated with the transition of the prior Spinosad authorized generic co-promotion and distribution partner that was in place under the former owner of the Natroba business, as we previously discussed. The incremental operating costs associated with the Natroba business includes salary and benefits costs for the sales team, selling and marketing costs of $1.2 million, supporting the commercial activities and other general and administrative costs of $500,000. Further contributing to the increase in selling, general and administrative expenses for the year ended December 31, 2024, was $1.6 million in legal costs related to a contractual arbitration process commenced by Cipher, resulting in an arbitration hearing in the first quarter of 2025. The arbitration is expected to be decided in the second quarter of 2025. Adjusted EBITDA for the year ended December 31, 2024, was $15.7 million compared to $12.7 million for 2023. The increase in adjusted EBITDA of 23% was largely attributable to the addition of approximately 5 months of the acquired Natroba business during 2024, partially offset by the legal costs incurred in the company's base business, as previously mentioned. In 2024, Cipher continued to generate strong cash flows overall. Cipher's base business generated $8.2 million of cash prior to completing the Natroba acquisition at the end of July 2024, representing a 20% increase in cash on hand during the 7-month period. The addition of the Natroba business has further contributed to Cipher's operating cash flows with a total increase in cash of $9.9 million or 123% during the remaining 5 months of the year post acquisition. Our business philosophy continues to be one of growth while maintaining strong earnings and cash-generating business. We'll not lose focus on this philosophy. Post-acquisition, Cipher generates meaningful free cash flows from both Cipher's base business and the acquired Natroba business. Looking ahead, our strong cash generative business, combined with the undrawn portion of our recently secured credit facility with the National Bank of Canada, which is at favorable market terms and whereby we continue to maintain a low leverage profile, provide the company with a substantial capital available to deploy as we continue to execute on our growth strategy and provide further value to our shareholders. We will now open up the call to questions.

[Operator Instructions] And with that, our first question comes from the line of Andre Uddin with Research Capital.

Now that your Natroba co-promote is done, how many sales reps and MSLs do you currently have?

Go ahead, Brian.

So after we completed the co-promotion transition, we had a complement of 30 outside reps at the end of the year, we call external reps, 12 inside sales reps and about 5 management employees.

And based on targeting high permethrin prescribers, how do they view Natroba? Like what sort of feedback has your sales force received?

The reception is very strong when it comes to Natroba because the product really sells itself. As you might know, permethrin is a product that was innovate -- like it was released 40 years ago. And there's been nothing else in a physician's toolkit to prescribe if they end up indicating that's what a patient has, which is scabies. So, when you're a physician and you've had nothing in your toolkit, except for something new, and it got designated as a complete cure in one treatment and it's done, the reception when our reps get to those physicians is pretty strong.

Andre, just to add to that, the resistance issue with permethrin is well known. And doctors are often searching for something that will work. And just to add to some of the comments that Brian made, Natroba has got a significant share of the head lice market and it's well known in that -- for that particular indication. We have found that it's not so well known for scabies. And we see that as a real opportunity because as we've told you before, the Natroba product has a complete cure rate designation from the FDA for scabies and no other product has that. So that's where I think that we can make a lot of headway is in the scabies market, and that is a very clear focus for us at the moment.

And just one last one. I know business development is always hard to time, but can you maybe elaborate a little bit on how out-licensing of Natroba is going in terms of timing?

I think that we're on schedule for that, Andre. Again, we're continuing to have discussions with at least 8 separate parties in 8 different regions. I'd say that we've got considerable interest from a potential partner in China, and those discussions are probably more advanced than other areas. We also have a strong indication from a Middle Eastern company that spans a number of countries. And those discussions are well beyond any CDA. I would put them both in the categories as advanced, and we're quite optimistic that we'll get a deal there being the first of a series of deals.

And your next question comes from the line of Justin Keywood with Stifel.

Nice to see the results. Just on some of the nonrecurring items, will the fees related to the M&A, will that roll off next quarter? Or are there still some onetime expenses? And same question related to the fair value adjustment of inventory.

Yes. So those will roll off. We'll have some impact in Q1 of 2025 for both of those items, but that should be the extent of it.

But far reduced.

Yes. That will be at a far reduced level than what we were seeing in the past two quarters.

Are you able to quantify that the onetime items expected?

Unfortunately, I can't really quantify that number for you right now, but it will be reduced over what we were seeing.

Okay. Great. And then very healthy cash generation in the quarter. I assume there's some use of tax loss credits. Are you able to break out what was generated for the business organically, if that's the way you look at it and what contributed from the tax loss balance? And what would be that remaining balance to potentially be used going forward?

Yes. So remaining tax losses going forward, and this is in U.S. dollars. So, $154 million of tax losses before any tax effect, obviously, on that.

And in the quarter, what was -- are you able to quantify what was utilized of that tax loss balance?

Yes. So about $11 million would have been utilized.

Great. And there's the ability to use that tax loss balance into the U.S., obviously?

Correct. Yes. We, the way we've structured the businesses, we're able to apply those losses for both sides, the Canadian and the U.S. business.

Okay. And then just on the market share of Natroba in the press release, it mentioned 23%. The incumbent, which has become ineffective has 75%. Is there a target market share, I guess, level that you're looking to get to in this year or next year? Or how should we be looking at that?

Justin, it's Brian here. We -- certainly, our current market share is at 23%, and we're seeing that very steady. We're commercializing and gaining ground and gaining physician demand, whereas nobody promotes a 40-year-old product like permethrin. So, for those reasons, we're very strong on being able to gain market share. In terms of how much we'll be able to get on an annualized basis, that's a difficult number to target, but we think about it as just total script growth. And our script growth targets are in kind of the low double-digit to mid-double-digit range. So that's the way we kind of take a look at the script growth that we're expecting to see from the business.

And again, Justin, just the -- we have a significant share of the head lice market, but scabies is low. The 23% that you're looking at is for the entire antiparasitic market. So, we think that we, and we're very focused on this, is gaining share in scabies segment of the business.

And by total size of the markets, I understand that scabies is much larger. Are you able to quantify that magnitude?

The total market of TRx for the antiparasitic market is about 1.1 million scripts and the scabies portion of that is somewhere in the range of 500 to 600 TRxs.

And I believe that the market size is around $165 million. Is that correct?

Yes.

[Operator Instructions] And I'm showing no further questions at this time. I would like to turn it back to Mr. Craig Mull for closing remarks.

Thank you. Before signing off, I'd like to take this opportunity to thank everyone for joining us today. We look forward to providing further updates on Cipher's continued growth. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.