Mayne Pharma Group Limited (MYX) Earnings Call Transcript & Summary

Good day, and welcome to Mayne Pharma Group Limited Full Year Results Call. At this time, I would like to turn the conference over to Mr. Scott Richards. Please go ahead.

Thank you, operator. Good morning, everybody. Thank you for joining us today to discuss Mayne Pharma's full year results for 2021. Joining me on the call is Peter Paltoglou, our Chief Financial Officer. As with past practice, I will provide an overview of the results and our key strategic priorities, and Peter will provide further details on the financial results, and then we will open up the call to questions. On Slide 4, we outlined some of the key operational and financial features of our results. In terms of the numbers, our results were impacted significantly by foreign exchange. On a current -- on a constant currency basis, revenue was $401 million, down 3% versus last year. Reported EBITDA was $66 million, down 5% and underlying EBITDA was $75 million, down 10%, excluding NEXTSTELLIS setup costs. A key feature of the result was the significant spend reductions with operating expenses decreasing $26 million or $18 million on a constant currency basis. And at the bottom line, we reported a net loss after tax due to a noncash intangible asset impairment of the generic portfolio that was reported in the first half. Whilst these results are not at all where we want our business to be, we have made strong progress on our strategy to reposition our company for growth. We achieved the first pass FDA approval for NEXTSTELLIS and established a new women's health platform in the U.S. We significantly expanded our dermatology and women's health portfolio, adding 11 new products and continue to grow our contract services businesses both in the U.S. and in Australia. Both CDMO businesses grew double digits in their base currency and the number of development projects grew 17% versus last year. In terms of COVID, our specialty products business was the most impacted across the year with reduced web access to physician offices compounded by either office closures or offices operating at significantly reduced capacity, which collectively drove down prescribing. As we've emerged through the post-vaccine era in the U.S., we've seen improved physical access to prescribers over the past quarter, running at around 80% of pre-COVID levels. I would note, though, that there are different levels of access at different -- in different parts of the country, and we have recently seen a stalling of positive trends here with the emergence of the Delta variant. Internally, we continue to be focused on protecting the health and safety of our employees and ensuring an uninterrupted supply of medicines to our customers. To that end, we maintained strong throughput at our manufacturing site with volumes up 30%, and we have seen minimal disruption through our third-party supply chains. While the ongoing challenges in the U.S. generic sector are well documented and our retail generic business continues to negatively impact our group results, I'm encouraged by the performance of our other business segments. Contract services delivered double-digit growth in U.S. dollar terms as the revenue, gross profit and operating profit line. Specialty products, which includes our dermatology, women's health and the infectious disease portfolio has delivered strong operating profit growth. And our international business or MPI, delivered double-digit growth at the gross profit line. Slide 6 of the results presentation shows our gross profit broken down into dermatology, women's health, contract service, international and the U.S. retail generics business. Excluding the U.S. retail generic business, the remainder of the business now accounts for 82% of gross profit, up from 56% 2 years ago, highlighting the rebalance of our company into what we believe are more durable and predictable businesses where we have a strategic basis to compete effectively. Moving now to operational highlights. Mayne Pharma achieved its first-ever NCE or new chemical entity approval for NEXTSTELLIS in April this year. This is the first approved product containing Estetrol or E4 in the United States and the first new estrogen introduced for contraceptive use in the U.S. for over 50 years. As a reminder, E4 is a low-impact estrogen with a unique mechanism of action that offers potential advantages over other estrogens. More than 10 million American women use short-acting contraceptives with more than 99% containing ethinyl estradiol, which is a synthetic modified estrogen. E4 is a naturally occurring estrogen now produced from a plant source. Slide 8 outlines the key features of NEXTSTELLIS, but essentially, this contraceptive offers a predictable menstrual cycle with an excellent bleeding profile and a low rate of typical adverse events such as acne and weight gain. NEXTSTELLIS was launched in late June following the recruitment and training of a new 70-person women's health sales team. The new team has now been in the field for 7 weeks and has made over 20,000 calls for high decile prescribers and held almost 2,000 educational promotional launches. In this short time, we've reached in person more than 60% of our target audience, which is ahead of plan. Our marketing strategy at this early stage is focused on building awareness of NEXTSTELLIS amongst key health care providers that write branded contraceptives, which are typically OB/GYNs and allied nurse practitioners. We recently received the results of our first market survey of prescriber since launch and are encouraged that 47% are aware of E4 and 68% are aware of NEXTSTELLIS. This compares with 2% and 15% awareness, respectively, at baseline following the approval in April. This awareness is translating into outcomes with 24% of those that are aware of NEXTSTELLIS reporting that they are writing prescriptions and 36% reporting the intention to prescribe over the next 6 months. Slide 10 of the presentation outlines the principal NEXTSTELLIS performance metrics we track internally. Gaining commercial insurance coverage is key in ensuring women can access NEXTSTELLIS at an affordable price. The vast majority of the oral contraceptive market flows through the commercial channel, and we are making very good progress with top payors and are currently sitting at 50% commercial coverage, of which 38% is unrestricted. Our goal by the end of this year is to have 60% unrestricted access, which has been a solid base from which to shift our marketing focus to the consumer. As NEXTSTELLIS is an NCE, there is a heavy sample focused initially. Over 30,000 samples have been distributed to physician offices, and our modeling indicates approximately 5,000 women are currently trialing the product. We have good visibility on prescription data and can track gross scripts written, scripts that are in the process of being dispensed, and scripts that are dispensed through the retail channel or through our specialty pharmacy partner, where more than half of that dispensed prescription volume is today. There are over 1,000 prescriptions that have been written since launch. The majority of which are in the process of dispensing due to women still using up their samples. As a reminder, NEXTSTELLIS participates in the combined hormonal contraceptive market, which is valued at USD 3.5 billion. Our business plan for NEXTSTELLIS is targeting peak net sales of more than USD 200 million, which represents 2% of the market by unit volume. Women's health is a core therapeutic area for Mayne, and we plan to create a leadership position in this market over time through the addition of novel therapy in areas of unmet need. We also want to leverage our generic portfolio of contraceptives, which covers more than 75% of the U.S. oral contraceptive market and includes pipeline products such as the generic version of NUVARING, which is pending at the FDA. Our second key therapeutic area is our dermatology business, which represents 29% of our gross profit. Over the last 2 years, this portfolio has faced challenging market conditions with COVID and decline in commercial insurance coverage. We've responded to these market dynamics by continuing to adapt our go-to-market strategy together with restructuring our sales team, which has included operating expenses declining by USD 9 million versus the prior year, which has significantly improved operating profitability. Today, the dermatology sales team promotes more than a dozen branded and generic products with support from an extensive network of independent specialty pharmacies across the U.S. We believe our dermatology platform offers advantages in terms of greater convenience and price transparency for patients, reduce administration for the physician and improved economics for the dispensing pharmacy. The last few months have been very active in dermatology on the business development front with 4 new supply agreements signed with leading pharmaceutical companies, including Sandoz, TYME, Cosette and Upsher-Smith to add 11 dermatology products to our portfolio. The interest we are seeing from other pharma companies in partnering with Mayne has grown substantially over the last 12 months and validates our innovative business model. The 2 largest pipeline products have combined IQVIA sales of USD 300 million with limited competition and are expected to be meaningful contributors to our business this fiscal year. We expect all of these products to launch across fiscal '22 with strong contribution to sales and earnings from this half. I now want to make a few comments about our U.S. contract services and the international business. Metrics contract services has demonstrated a solid track record of double-digit growth over the last 8 years and remains one of only a few U.S.-based CDMOs capable of early-stage development through the commercialization from a single contiguous site. It has over 100 clients and supports 13 of the top 20 global pharma companies. In the last year, the business delivered strong results, with sales up 10% and gross profit up 18% in U.S. dollar terms, driven by new commercial manufacturing revenues. The second half performance was even stronger with sales up 20% on the first half. We continue to see favorable dynamics in the CDMO market with the growth of compounds in clinical development and growing outsourcing trends. Our capability to focus on high potent oral solid dose processes, which is very aligned to the growth we are seeing in new molecule programs in the oncology space. Going forward, metrics has a buoyant pipeline of development projects across the pharmaceutical value chain, including 22 projects in Phase I, 20 projects in Phase II and a dozen projects in Phase III. In fiscal '22, 5 metrics clients are expected to file NDAs with the FDA. MPI or our international business, also has a demonstrated track record of growth since fiscal '15. The international business operates out of the Salisbury, South Australia facility, which is the largest Australian-owned full-service solid dose site manufacturing both TGA and FDA registered products. In fiscal '22, the business benefited from strong sales growth in CDMO unit, which grew 11% and Australian product sales were up 6%. At the gross profit line, MPI achieved double-digit growth, benefiting from record volumes at our Salisbury plant, which were up 60% on the prior corresponding period. The outlook for the international segment is very positive with a solid pipeline of new product launches expected to support growth of the Australian products business. SOLARAZE gel and ACTIKERALL topical solution were recently added to the Australian portfolio. Both products are indicated for the treatment of actinic keratosis. And these will be promoted by our existing sales team, focusing on dermatologists and general practitioners that specialize in skin cancer. And next year, we have the potential launches of NEXTSTELLIS and FABIOR in Australia, which are both pending at the TGA. With that, I'll now hand over to Pete, and he'll go into further details about the results.

Thanks, Scott, and good morning, everyone. I will take a few minutes to provide a brief overview of our financial results for the year. On Slide 21, you will see that foreign exchange has clearly had a material negative impact this year on our results with the average AUD-U.S. dollar strengthening over 10% from $0.67 in the prior corresponding period to $0.75 in financial year '21. At the top line, reported revenues were $401 million, down $56 million versus the prior period, with a weaker U.S. dollar accounting for $40 million of the sales decline. On a constant currency basis, revenue was down 3%. The balance of the sales decline was due to further erosion of the retail generics segment of GPD. Reported gross profit was $182 million, down 5% on a constant currency basis, and the gross margin of 45.4% was essentially flat. Reported EBITDA was $66 million, which steps up to $76 million on a constant currency basis, representing a 5% decline versus the prior period. We have provided 2 versions of underlying EBITDA in the documents today, 1 excluding NEXTSTELLIS setup costs as we did in the first half, and 1 including these costs to be consistent with how analysts have treated NEXTSTELLIS in their research reports. The total FX impact to the EBITDA line was around $10 million, as noted earlier, which includes the translation FX impact of $7 million, a transaction currency impact of $1 million and the balance from the revaluation of trading assets. Slide 22 of the presentation outlines the underlying adjustments to EBITDA. The 2 key ones are the noncash credit of $20.6 million arising from a decrease in the fair value of earn-out liabilities and $15 million of restructuring costs comprising organizational changes we implemented across our global business throughout the year, and the discontinuation of certain nonviable generic products and development programs. These changes are expected to drive annual cost savings of up to USD 10 million in financial year '22. At the bottom line, we reported a net loss of $208 million. A key component of this result is the noncash impairment of our generic intangible assets, which was taken in the first half. In terms of our operating businesses, Scott has already talked about and the international segments. I will now make a few high-level comments on the specialty and generics businesses. The specialty products segment, U.S. dollar sales and gross profit were essentially flat versus pcp. Operating profit, however, was up 66% due to the significant reduction in marketing expenses following the restructure of the dermatology platform and refresh of our go-to-market strategy in this segment. Dermatology sales were down by USD 3 million with COVID affecting access to physicians as well as a tougher managed care environment with increased rebating required for commercial coverage. SPD benefited from the launch of NEXTSTELLIS and SOLTAMOX, which contributed USD 3.5 million in sales. NEXTSTELLIS sales in June were driven by inventory stocking into key wholesalers. Going forward, we expect limited sales of NEXTSTELLIS in the first quarter of the fiscal year, with the second quarter expected to see sales revenue more closely track prescription demand. GPD revenue was down 10% versus pcp, impacted by ongoing pricing pressure across the portfolio as wholesaler bidding activity stepped up. Two new competitors launched on liothyronine in the second half, impacting sales of this product, which were down over 50% versus the first half. While this represented a significant headwind in our financial year '21 results, further rationalization is occurring across the generics industry in the U.S., driving incremental new opportunities in select product markets, which we continue to carefully monitor. Across the period, more than 10 products were transferred into our own facilities or into new manufacturing sites, which will provide a stronger basis for competing in the coming year. Future performance of the generics segment will continue to be heavily influenced by the timing of FDA approvals and the competitive intensity of key product markets. We continue to optimize the performance of our generic portfolio, including discontinuing unprofitable products, reducing stock obsolescence and streamlining our cost base through realignment of supply chain activities with raw material suppliers and CMOs. Moving to expenses. Our OpEx cost base reduced in total by $26 million or $18 million on a constant currency basis. This excludes NEXTSTELLIS setup costs. Within OpEx, marketing and distribution costs were down by $16 million or $11 million FX adjusted, reflecting the restructure undertaken last year in the dermatology business, both to reduce costs and improve alignment with our business model. Admin and other expenses were down $13 million, but this includes a number of noncash and nonoperating items. Note 4 of the accounts provides a detailed disclosure on our admin expenses. Excluding these noncash and nonoperating items, admin and other expenses were down $10 million or $7 million FX adjusted. In terms of the other key expense buckets, gross R&D spend, including both capitalized and expensed amounts, was $26 million, down $9 million on pcp, whilst net R&D expense was $22 million, down $3 million on pcp. The R&D capitalization rate fell from 31% to 18%, reflecting the reduced generic R&D spend, as we continue to pivot our development activities towards specialty products. Total finance expenses increased by $1 million, although this includes interest expense and the number of noncash items, such as the discount unwind on earn-out liabilities. This item increased $5 million in financial year '21 due to the full year effect of the NEXTSTELLIS earn-out liability. Interest expense related to our debt facilities was $11 million, down $3 million from the prior period, benefiting from an improved cost of funds with the average interest cost declining from 4.1% in financial year '20 to 3.7% in the current financial year. In terms of cash flow, operating cash flow represented an inflow of $59 million for the year. Whilst down significantly from financial year '20, the prior year benefited from a $50 million release of working capital. Adjusting for these working capital changes and additional favorable cash tax impacts, operating cash flow was $62 million versus $65 million in the pcp. This year, there has been a small investment in working capital due to a number of factors, including the launch of NEXTSTELLIS, sourcing decisions related to API and finished dose manufacturing, and supply continuity of key products during COVID. We note that our supply interactions with Teva have largely wound down with ostensibly all manufacturing activities now moved to their final destination sites. The key cash flow investing items were $17 million of CapEx spent on our 2 manufacturing facilities, $24 million of earn-out payments, $3 million on product acquisitions and $5 million for capitalized R&D. Included in the investing cash flows was the FDA approval milestone of USD 11 million paid to license partner, Mithra, in April earlier this year. After investing cash flows, the company produced free cash flow of $10 million, enabling net debt to fall by that corresponding amount. In terms of bank covenants, our bank leverage ratio was 2.6x versus a covenant of 3.75x, and interest cover was 7.9x versus the covenant of 3x. The shareholders' fund covenant continues to remain in compliance with shareholders' funds of over $770 million. Looking forward, we remain focused on generating free cash flow, deleveraging the balance sheet and prudently controlling our spending. Capital efficiency and allocation will be a key area of emphasis in financial year '22 as we continue to look for further opportunities across our balance sheet to optimize returns to our shareholders. We have a significant asset base across both key geographies, which provides optionality as to further nondilutive funding to support our growth strategy across the group. We have many programs underway to further improve our cost base, strengthen our supply chain and reduce product manufacturing costs. We anticipate upsizing our receivables financing facility this year to fund the working capital investments. We expect for a number of new product launches on the dermatology side and also to support the ramp-up of NEXTSTELLIS. And with that, I will now hand back to Scott.

Thanks, Peter. So look, in summary, Mayne Pharma's key priorities for the coming year is the successful commercialization of NEXTSTELLIS in the United States. The launch of more than a dozen dermatology and women's health products also in the United States. Accelerating the growth of metrics contract services and our international business, whilst, of course, continuing to drive an efficient operational cost base across the company. And with that, I'll now hand back to the operator, and we can take questions.

[Operator Instructions] We will take our first question from our participant. [Operator Instructions]

It's Saul Hadassin at Barrenjoey Capital. Can you hear me, Scott?

Yes. I can, Saul.

Scott, just the first one, and Peter might have covered this, I might have missed this in his remarks about NEXTSTELLIS sales through FY '22. But can you give us any sense of your expectations, just noting that inventory build into the back end of FY '21. Any rough guess of where those sales might end up through FY '22?

Yes. Look, Saul, we haven't provided any specific guidance on sales for FY '22. Obviously, it's a critical year. The launch ramp is critical for our ultimate destination with more than $200 million in peak sales. I think we'll have a better idea, and we'll be able to provide probably more color on that once we get through this sampling phase with patients. But as I said earlier, in my opening comments, every key performance metric we're tracking today is either on plan or ahead of plan, and our plan is consistent with our ultimate destination. As you know, peak sales will be -- as we've always said, peak sales will be in 3 to 4 years' time.

Yes. Understood, Scott. And just another one, the slide where you talk about the dermatology products that have been licensed with partners in the generics space. Can you just confirm -- you mentioned most of them don't have significant competition. Where -- talk to the number of approved dermatology products by partner, are they current -- the drugs currently in existence in the market? Are you adding to those numbers with entry in terms of the level of competition across those products?

Yes. So we are partnering with companies that have -- either have an existing presence in the market, but we are their exclusive distributor in our independent specialty channel, where, as I think you realize, dermatology products have a significant distribution presence. So in some cases -- in most cases, there is an existing product of that partner, but it's not in the channel of business that we are in, because that's where we have expertise as opposed to, say, in the retail channel. So that's the basis of the partnerships, generally speaking. And further, 2 of the products, in particular, are significant in size. As I mentioned, USD 300 million. They are products that are meaningful in terms of their potential for us in our channel and both have limited competition, and both have, if you like, some intrinsic barriers to entry as well.

Great. And just last quick one for Peter maybe. Peter, just looking at those covenants that you have, and I guess particularly focusing on the shareholder capital base or shareholder funds base. I guess the headroom there is somewhat limited if there was to be, say, for example, further impairments in the generics business. What's your sense as to whether that's likely to occur? Or if you think you've now reached a floor in terms of those -- the write-down in that division?

Saul, we had 2 CGUs that are related to our generic assets in the U.S. One of those we classify as GPD other, and that has a relatively small amount of intangible value that remains ascribed to that CGU, whilst GPD women's health, our other generics CGU, has a slightly higher number, both as you will see in Note 13 of the accounts have reasonable headroom from a recoverable value sense to their carrying value. So we feel reasonably comfortable that we're in a good position on both of those CGUs going forward.

We will take our next question from our next participant.

It's Gretel Janu from Credit Suisse here. First question, just on specialty brands. So second half performance on a constant currency basis was actually below first half, just when I look at it on a half-on-half basis. So what happened in second half to drive that lower revenue performance?

Yes. Thanks, Gretel. Well, look, 2 things or 2 or 3 things. One, there were some ongoing -- as I said in my opening comments, there's been ongoing pressure on commercial insurance coverage on some of our dermatology brands. That's part of the story. The other part is there is a significant difference between first half and second half, and you'll see that in the prior year. If you look at the prior year across our dermatology brands, there was a significant downturn in the second half versus the first half. And in fact, the second half of the year we've just had is quite comparable to the second half of the previous financial year. And the reason for that, as I think I've talked about before, is that in January, there's basically everybody's insurance program. Those people that are on a high deductible insurance program, which is an ever-increasing number of Americans get their deductible reset. So as a result, we're covering more patients with their co-pay card, and therefore, our net selling prices effectively are dropping. That then recovers through the year. So there's always a pretty significant half-on-half, January to June versus July to December effect as those deductibles have burned through and the co-pay card support that we provide starts to come off. So I would encourage you to look at the dermatology business half-to-half versus pcp, if that makes sense. I mean COVID, of course, continues to be in effect. COVID was in effect, of course, in the first half, that is what -- and there's also -- there was a significant COVID effect in the first quarter of this calendar year, as I said in my remarks, it's been getting better in terms of access to physician offices in the second quarter, but beginning to stall a little bit again right now.

Understood. So I guess just in terms of the exit run rate then for the specialty brands, I guess, how much recovery have we seen from that COVID downturn, and should we be expecting stronger growth into FY '22?

Yes. Look, you should certainly be seeing -- I mean there's 2 elements of growth. I mean, certainly, the half-on-half phenomenon around high deductible plan resets and then patients meeting their deductible and the manufacturer taking less of the burden, that will be an ongoing phenomenon as per our brands, from the first half of this calendar year to the second half, as we've seen in every other prior year. Of course, with the restructuring of our sales force, not only have we taken operating costs out that we had the benefit of, of course, in fiscal '21. But we've also changed quite radically our go-to-market model with the remaining team. And look, I can say at this early juncture, we're already beginning to see some of the benefits of that in terms of our underlying prescription data on key products. So I think those 2 things, just the time of the year on the high deductible piece, and the benefits coming from the sales force effectiveness are going to be tailwinds we should enjoy. And then, of course, I mentioned the addition of 11 dermatology products, of which all of them are important, because we're building a portfolio approach here. But 2 of them in particular could be material to the dermatology business across fiscal '22. And one of them is going to launch very shortly. And the other, hopefully, in the not-too-distant future, and both have limited competition. And of course, the way we sell these products, even though they're generics, we don't really sell them as generics. We're dealing with physicians. We're dealing with our specialty pharmacies. We're dealing with patients. We provide support to patients so they pay a reproducible price. And as a result, we can command a premium over the retail channel. So this is quite a captive market, and it's the reason why and in our ability because of our sales team and our relationship with the specialty pharmacies and our relationship with doctors gives us the ability to drive a segment of business that generic companies can't. And that's why we've been successful at partnering with a number of companies that we've just announced.