Good day, welcome to the Mayne Pharma Group Limited results half-year call. At this time, I would like to turn the conference over to CEO, Mr. Scott Richards. Please go ahead, sir. Thank you very much, good morning, everybody. Thank you for joining us today to discuss Mayne Pharma's half year 2021 financial results. Joining me on the call is Peter Paltoglou, our Group CFO. As with past practices, I will provide an overview of the results, our key strategic priorities, how our operating segments have performed, and Peter will provide some additional detail on the financials, and then we'll open up the call for questions. Firstly, I'd like to give a quick update on COVID. Transmission still remains very high here in the U.S. and the communities in which we operate. The health and safety of our employees remains a key focus, and we continue to adapt to the evolving environment. Pleasingly, our manufacturing output has continued to grow inside our facilities, and we've seen minimal disruption to our third-party supply chain or prosecution of our R&D programs. Further, our dermatology sales team has performed very well, despite on average a 50% drop in in-person office calls through effective utilization of various virtual engagement platforms, which have allowed us to maintain overall reach and frequency metrics close to the pre-COVID levels. Moving to the group results. Reported revenue and gross profit were down from the prior corresponding period, impacted largely by FX and weaker performance from our retail generics business. On a constant currency basis, the decline was 3% at the top line and underlying EBITDA was AUD 44 million, down 7% on the prior corresponding period. At the bottom line, we reported a net loss after tax due to a non-cash intangible asset impairment of the generic portfolio. Whilst this is obviously disappointing, it reflects our latest view on trends in what remains a highly competitive U.S. retail generics segment. Operating cash flow was solid at AUD 46 million ahead of EBITDA and helped us to reduce net debt by AUD 40 million over the half. Whilst ongoing challenges in our retail generics business continue to impact our group results, we are encouraged by the performance of our other business segments during this difficult operating environment. Slide six of the results presentation shows our gross profit broken down into U.S. retail generics, contract services, dermatology, women's health, and our rest of world business. Excluding the U.S. retail generics segment, the remaining business grew 70% on a constant currency basis at the gross profit line, and these categories now account for 77% of gross profit for the group, up from 46% two years ago. Going forward, we expect to see a further reduction in the retail generics business as a percentage of the group and women's health will become the largest category following the launch of key pipeline products such as NEXTSTELLIS and generic NuvaRing. We also realized significant spending reductions this half. OpEx and gross R&D spend decreased by AUD 19 million, made up of an AUD 12 million decrease in OpEx and an AUD 7 million decrease in gross R&D spend as we wind back development spending on retail generics and focus on progressing our proprietary or branded pipeline. Moving to the operational highlights. Our key near-term priority is of course the commercialization of NEXTSTELLIS, our novel oral contraceptive with a new estrogen, estetrol or E4. The product is pending at both the FDA and the Australian TGA. In the U.S., the product was accepted for filing in June 2020 and has a target action date with the FDA in April of this year. We've had two positive meetings with the FDA in September and January as part of the dossier review, with no substantive issues identified to date. Subject to regulatory approval, we're planning to launch NEXTSTELLIS in the U.S. market around the end of this half and early next calendar year in Australia. Slide eight outlines some of the key features of NEXTSTELLIS. If approved, E4 or estetrol will be the first new estrogen introduced in the U.S. for contraceptive use in 50 years. E4 is a low-impact estrogen with a unique mechanism of action that offers potential advantages over other estrogens. Our marketing strategy is focused on building awareness of NEXTSTELLIS amongst key stakeholder groups, such as healthcare providers or prescribers, payers, and consumers. In 2020, we conducted four advisory board meetings in the U.S. There was strong interest in the science, E4's mode of action, and the clinical data from phase II and phase III trials that were conducted in over 4,000 women. In terms of the NEXTSTELLIS commercial team, we've made a number of key management appointments, as outlined on page 10. Many of these new appointments have significant experience in leading women's health companies such as AbbVie, Allergan, and Bayer. The new team will be supported by a field force of approximately 75 people who will be focused on reaching high-prescribing OB-GYNs. If approved at our April target action date, the NEXTSTELLIS launch costs, covering sales force, medical education, and marketing activities, are expected to be approximately $10 million in the second half of this financial year. As a reminder, NEXTSTELLIS will participate in the combined hormonal contraceptives market, which is valued at $4 billion. The largest branded product by revenue in this market is Lo Loestrin Fe generating $500 million in annual net sales. Our business case for NEXTSTELLIS is targeting peak net sales of $200 million, which represents just 2% of the market by units. Other key highlights this year include the launch of four new products in the U.S. Two branded products, sulfacetamide sodium solution, and a new dose strength of DORYX and two generic products. Since the beginning of this calendar year, we've also launched three further oral contraceptive products that were sourced from our new partnership with Novast Laboratories. Two of the products are generic versions of the top two prescribed contraceptive products in the U.S. today, Ortho Cyclen and Ortho Tri-Cyclen. In dermatology, we continue to actively assess further opportunities to license certain generic products to expand our portfolio in the specialty pharmacy channel. We do believe our go-to-market dermatology platform can offer a more effective distribution model that provides advantages in terms of greater convenience and price transparency for patients, reduced administration for the prescriber, and improved economics for the dispensing pharmacy. We're currently in active discussions with partners for another eight generic products to add to our growing portfolio. In terms of our pipeline products, we continue to advance our key programs with the FDA. We expect to respond to our generic NuvaRing CRL by the end of this quarter and have another five products pending approval, plus three other products that have been approved, which we are targeting to launch this calendar year. These nine pipeline products have combined IQVIA sales of $1.5 billion, of which NuvaRing represents $800 million. Moving to the operating segments. Starting with Metrics Contract Services. This business performed well in the half, with USD sales up 6% and gross profit up 12%, benefiting from new commercial manufacturing revenues and improved business mix. Commercial manufacturing grew strongly and now represents 14% of MCS sales versus 3% in the prior corresponding period. Metrics has five commercial clients, including two top 10 global pharma companies, and is now approved as a manufacturer in 40 countries. Growth in the commercial business reflects the capital investments we've made at the Greenville, North Carolina facility. Most recently, we invested a further $10 million to expand capacity and support the pipeline committed business. We continue to see favorable market dynamics in this segment, and it's benefiting from an increase in outsourcing just generally in development and manufacturing and the growing number of oncology compounds in clinical development, which the Greenville facility is well suited for. The market continues to grow in the mid-single digits, well above the broader pharmaceutical industry, and many businesses have been sold in this space for trailing 12-month EBITDA multiples in the mid-to-high teens. Also, publicly traded contract services companies like Catalent, Lonza, Siegfried, and Recipharm also trade on significantly higher multiples in the broader pharma sector. Moving to our Specialty Products Division. USD sales were down 6% from the first half versus TCT, but pleasingly, were up 32% on the second half of fiscal 2020, benefiting from some improvement in COVID-related access and underlying demand, and also improved gross and net performance. The last few years have seen a significant increase in managed care costs as PBMs have consolidated and they've leveraged their market position to demand higher rebates in return for commercial coverage. This dynamic effectively reduces the net selling price of branded products and shifts the burden to manufacturers like Mayne Pharma to ensure patients can get their medicines at an affordable price. We've responded to these dynamics by making proactive co-pay card changes, restructuring the dermatology sales force, and changing how we market our products. Direct operating expenses, which capture the sales team marketing and distribution costs, have decreased by $5 million or 28% this half, while prescription performance across the total dermatology portfolio of brands and generics has remained steady. Pleasingly, the direct operating profit from Specialty Products Division, which was disclosed on page 20 of the presentation, has increased 40% versus the prior corresponding period as a result of these initiatives. Today, the dermatology sales team work with an extensive network of specialty pharmacies and provide access to more than a dozen branded and generic dermatology products, and more than 85% of this segment's sales are through this specialty pharmacy channel. TOLSURA, our improved formulation of itraconazole, has faced a very challenging 2020, impacted more significantly by COVID-19 than our other businesses, given many of our key customers and prescribers are hospital-based. Despite that, we're beginning to see signs of growth again in the final quarter of 2020, with sales, units, and dispensed prescriptions above all prior quarters since launch. We're also making further investments this half in the field team footprint and various marketing initiatives to drive further awareness and growth in anticipation of emerging from COVID restrictions this year. We do remain very confident in the potential of this product to capture a meaningful share of the itraconazole market. We also see broader application of this product in other fungal infections such as valley fever and as a potential anti-cancer treatment, with our most advanced program being in basal cell carcinoma and Gorlin syndrome. Moving to generic products. USD revenue was down 8% on the prior corresponding period, impacted by ongoing pricing pressure across the portfolio and limited benefit from new product launches. Product performance was mixed, with growth in budesonide and carbidopa/levodopa offset by weaker performance of butalbital, metoclopramide, and aminoglutethimide. The future performance of the generics segment will continue to be heavily influenced by the timing of FDA approvals and any competitor launches and withdrawals of key products. We continue to rationalize the generic portfolio and discontinue unprofitable products. We're reducing stock obsolescence, and we're optimizing the cost base through the realignment of our supply chain with more material suppliers and contract manufacturers, such as Novast Laboratories, where we've secured supply on more favorable terms for eight contraceptive products. Over FY 2021, 12 product transfers are expected to be completed into our own facilities or into new contract manufacturers, which is expected to improve our product cost base. The aggregate impact of these initiatives and new product launches will continue to offset expected ongoing price erosion in the base retail generic business. To underscore this last point, our largest retail generic product, lidocaine, saw a new competitive launch recently. Moving to our last segment, Mayne Pharma International. Our rest-of-world business recorded sales growth of 10%, driven by strong income from providing development and manufacturing services to third parties. This third-party income increased 35% from the prior corresponding period and benefited from seven new development projects and growth in contract manufacturing revenues. The stronger gross margin reflects overhead recovery benefits at our Salisbury site, with dose volumes up almost 50%. With that, I'll now hand over to Peter, who will go into further details about the results. Thanks, Scott. Good morning, everyone. I will now provide a high-level overview of the result and take you through the key profit and loss balance sheet and cash flow movements this half. FX has had a material negative impact this half, with the average AUD dollar exchange rate relative to the USD strengthening AUD 0.04 from AUD 0.685 in the prior corresponding period to AUD 0.723 in the current period. FX has several impacts on the P&L, which I'll discuss in further detail as we work through these results. At the top line, reported revenues were AUD 209 million, down AUD 18 million versus the prior period. The softer revenues were a result of both the weaker US dollar, which accounted for $11 million of the sales decline, along with continued challenges in the retail generics segment of GPD. On a constant currency basis, revenue was down 3%. Reported gross profit was AUD 96 million, down AUD 10 million, and the gross margin of 46.5% was essentially flat versus the prior corresponding period. Underlying EBITDA, on a constant currency basis, was AUD 44 million, down 7% on PCP, with FX impacting this by AUD 4 million. This FX loss comprised three components: the revaluation of trading assets of AUD 1.4 million, a translation FX impact of AUD 2 million, and a transaction currency effect for the balance. Reported EBITDA was AUD 40 million, up AUD 6 million or 16% versus PCP. Slide five of the presentation outlines the underlying adjustments to EBITDA. There are two adjustments that I wanted to call out. A non-cash credit of AUD 5.6 million arising from a decrease in fair value of earn-out liabilities, and we also added back AUD 1.4 million of set-up costs for the establishment of the women's health platform for NEXTSTELLIS. This is consistent with the approach we adopted when we acquired DORYX and set up our branded dermatology platform and related organizational infrastructure. We will have a further adjustment taken up at the full year for these pre-launch activities, which will enable better look-through to underlying business performance for fiscal year 2021. Once approved, NEXTSTELLIS operating costs will be included in the underlying result. At bottom line, we reported a net loss of AUD 181 million, which was largely due to the AUD 215 million non-cash impairment of our generic intangible assets. This impairment was driven by the revised outlooks for the generics business due to increased competitive pressures in certain on-market and pipeline products, along with additional pricing headwinds more generally across the retail generics portfolio. Moving to expenses. Pleasingly, our cost base continues to be effectively managed, with OpEx reducing AUD 12 million or 18% versus PCP. Within OpEx, marketing and distribution costs were down AUD 11 million, reflecting the restructure undertaken last year in the dermatology business, both to reduce costs and improve alignment with our go-to-market business model in this segment. Admin and other expenses were down AUD 5 million to AUD 56 million, although this includes a number of non-cash and non-operating items. Note three of the accounts provides a detailed disclosure on our admin expenses. Excluding these non-cash items, admin and other expenses were down AUD 1 million versus PCP. Gross R&D spend, including both capitalized and expensed amounts, was AUD 13 million. Down AUD 7 million on PCP, whilst net R&D expense was AUD 10 million, down AUD 2 million on PCP. The R&D capitalization rate fell from 37% to 20%, reflecting the reduced generic R&D spend as we continue to pivot our development activities towards Specialty Products. Total finance expenses increased by AUD 5 million, although this was due to the non-cash discount unwind effect from the earn-out revaluation associated with the NEXTSTELLIS earn-out liabilities. This will continue to be a component of our results given the structure of the NEXTSTELLIS product license with Mithra Pharmaceuticals. Interest expense in the P&L, which captures the cash costs of the debt facility, was AUD 6 million, down AUD 1.2 million from PCP, benefiting from an improved cost of funds with lower LIBOR BBSY rates, reducing the average interest cost from 3.7% PCP to 3.3%. In terms of cash flow, operating cash flow was another healthy result with an inflow of AUD 46 million, which was above underlying EBITDA, demonstrating strong cash conversion across the business. We've now had seven consecutive halves in which operating cash flow has been above AUD 45 million. The key investing items this half were AUD 6 million of CapEx spent on our two manufacturing facilities, AUD 8 million of earn-out payments, and AUD 5 million on product acquisitions and capitalized R&D. After investing cash flows, the company produced free cash of AUD 28 million, almost double the prior corresponding period. This was a strong outcome and has helped us further improve our balance sheet position across the first half. A key highlight of this result is the improvement in net debt, which has fallen by AUD 40 million due to the production of this free cash and the strengthening Australian dollar. Our bank leverage ratio was two times for the half versus a covenant of 3.75 times, falling from 2.5 times as at the end of June 2020. In December 2020, we completed a restructure of our debt facilities, creating more balance sheet flexibility. We extended the AUD 100 million syndicated bullet facility by four years to November 2024, and also improved covenant terms, including the reduction of the shareholders' fund covenant to AUD 600 million. It is worth highlighting that over the last two years, we have generated almost AUD 200 million of operating cash flow, of which AUD 90 million was free cash flow, and reduced our net debt position by 30% or AUD 90 million. During this period, we have internally funded various important growth initiatives, including site expansion, key R&D programs, and selected business development activities. We've invested more than AUD 60 million in R&D, AUD 60 million in product acquisitions and licensing activity, and AUD 20 million in our manufacturing facilities to set up the business for a more sustainable future in our selected markets. Looking forward, we will continue to remain focused on generating strong cash flows, further reducing our debt position, and prudently controlling our spending. We have many programs underway to further strengthen our supply chain, reduce product manufacturing costs, and optimize costs that sit between gross sales and net sales. We have 12 tech transfer programs expected to be completed this year, a number of programs underway to secure more efficiently priced API, and we also have process improvement programs at our plants to increase overhead recovery benefits, and initiatives to further reduce stock obsolescence returns and the cost of co-pay cards. With that, I will now hand back to Scott. Thanks, Pete. Look, in summary, Mayne Pharma's key priorities have not changed. We remain focused on the successful commercialization of the novel oral contraceptive, NEXTSTELLIS, which is getting closer to our launch and is expected to be the key near-term transformational event for our company. We'll also continue to expand our dermatology and women's health portfolio through business development and R&D activity. We'll continue to accelerate our global contract services platforms. We'll continue to maximize the severe itraconazole franchise with TOLSURA, and also continue to optimize our cost base with a particular focus on our generic portfolio product costs. With that, I'll now hand back to the operator, and we're open for questions. If you would like to ask a question, please signal by pressing *1 on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. A voice prompt on the phone line will indicate when your line is open. Again, press star one to ask a question. We can go ahead with our first question. That is from Saul Hadassin with UBS. Please go ahead, sir. Thanks very much. Good morning, Scott and Peter. Scott, just a question from me regarding NEXTSTELLIS and the impending decision by the FDA. You mentioned sort of the aspirational revenue target. I'm just wondering if you can give us a sense as to, realistically, just timing for those revenues to ramp, particularly, I guess, in the COVID environment in the U.S. extending through this part of this calendar year, your ability to get out of market into specialist rooms and, I guess, yeah, just a timeframe as to how long it might take to get to that AUD 200 million in sales. Yeah. Thanks, Saul. Just in terms of access to physician offices. We see the OB-GYNs, they used to be similar to dermatology. In dermatology we have good access, 50%, 60%, 70%, depending on which part of the country you're in. That is getting better every day now. Further to that, when we can't be there in person, we're finding virtual engagement to be quite effective. The vast majority of our dermatology physicians, we have access to, and that's reflected in some of the comments I made about our underlying demand and performance in the SPV area. We expect a similar situation in the OB-GYNs space. Given that the majority of the sales team that we'll be hiring will come from that space, they'll have the advantage of those existing relationships as well. In terms of the AUD 200 million headline number, that'll be generated over a number of years. We haven't been absolutely specific about that. The trajectory will depend upon, obviously, the effectiveness of our sales team. It'll also depend upon the effectiveness of our interactions with managed care. We do expect this segment, based on other analogs, to be very well covered, certainly better covered than in dermatology that I referenced earlier today. We don't expect headwinds there. Look, it'll be a build, but classic brands like this, I would expect us to be getting somewhere towards peak sales in year three or thereabout. Great. Thanks for that. Just one other from me. Just on NuvaRing and noting again your comments, as it relates to the feedback that you're anticipating. We've seen another generic entrant. Just your thoughts on that market as it stands today and your ability to compete, even when you do get a product into market in the U.S. I guess, what have you seen in terms of the genericization of NuvaRing to date from the brand and just your expectations on your ability to compete once you are able to play in that space? Thanks. Yeah. Well, look, obviously there's an additional approval. From an internal business case standpoint, we did expect to be behind Teva. Look, we think we'll still be able to compete, and we'll be able to compete in two ways. One, this is a very big market. Our ability to strike decent share, I think is still very valid. That's our expectation. Clearly, an additional competitor versus not having an additional competitor does make this market smaller. It's coming off obviously a very high base at over $800 million. The second thing to note here is, unlike any of our generic competitors, we will have a front-end women's health sales team, obviously focused on NEXTSTELLIS, but we do have a very large portfolio, which will then be complemented by NuvaRing of branded generic contraceptives. You should expect to see from Mayne Pharma, a game plan here where we'll compete in the retail space with the other generic companies in a classic way, but we will also compete in alternative channels using our direct relationships with physicians in this space, which these other generic companies don't have. A bit like what we've done over the last four or five years in dermatology. Great. Thanks very much. That's all I had. Thanks, Saul. We will go to our next question from Gretel Janu with Credit Suisse. Thanks. Good morning. Firstly, just in terms of underlying EBITDA, I think at the AGM trading update, you did make the comment that underlying EBITDA was marginally ahead of the PCP. It did end up down 7% from a constant currency perspective. I guess what happened in November and December, for it to be quite a different result between what we're saying in the AGM? Yeah. Look, I'll let Pete add something here, but if I can just say to start. It'd be fair to say that we didn't see some of the wholesaler buying patterns that you traditionally see, as you enter the Christmas, New Year holiday period. Usually, there's an extra week or two of buying, which is not insignificant in our generic business. That didn't happen this year.