argenx SE

Good morning. My name is Rob, and I will be your conference operator today. At this time, I would like to welcome everyone to the call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, followed by the number 1 on your telephone keypad. If you would like to withdraw your question, again press star 1. Thank you. I'd like to introduce Beth Diljaco, Vice President of Corporate Communications and Investor Relations. You may now begin your conference.

Thank you, Operator. A press release was issued earlier today with our first half 2022 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. Argenix is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Hauermeren, Chief Executive Officer. Carl Gubitz, Chief Financial Officer, and Keith Woods, Chief Operating Officer. I'll now turn the call over to Tim.

Thank you, Beth, and welcome, everyone. We are just halfway through 2022, and it has already been a year of incredible execution by our team outlined on slide number three. We are delivering on two commercial launches, one in the United States and one in Japan, and are now looking ahead to broaden the global reach of VidGuard. We had two positive phase three data readouts in the first half and are positioned for the series of trial starts and additional data readouts over the next 18 months. And we were able to finance our ambitious business plan in a difficult market environment. We live by our reputation for execution, so I want to start by saying thank you to the Argenix colleagues for their thorough preparation and steadfast determination to achieve our goals. and to our stakeholders, our shareholders, our physician partners, and of course, our patients. To begin, the second quarter of our safeguard launch showed significant growth from the first quarter with global net product sales of $75 million. It will expand on our progress across our patient, physician, and payer segments later in the call, but at a high level, I'm really happy with the team's hard work. They were well prepared going into approval with carefully crafted strategies and continued to execute on them. A few highlights to point out on slide number four. Our market access team delivered what they promised and secured broad coverage in the first two quarters of launch. This was crucial in converting physician prescriptions to patients on therapy. We are getting regular feedback from physicians and patients on their experience with VivGuard, which, while anecdotal, aligns with data from the ADAPT trial, including on the fast onset of action and minimum symptom expression. MSC was an exploratory endpoint in our trial, but a metric that is growing in importance amongst neurologists because of its practical meaning for patients. This feedback is also in line with what we hear from GMG patients and their advocates on the significant unmet need that still exists. We have learned firsthand, and through our outcomes research, what a devastating and debilitating disease GMG can be. With its novel mechanism of action, DriftCard has the potential to transform the treatment landscape and significantly improve patients' lives. Hearing stories from patients who are already experiencing this benefit has been the most rewarding part of the last six months. I am equally very proud of our ongoing commitment to be leaders in FCRN, not only from the commercial side, but also the scientific. Our approach starts with solid science and is backed by strong data, and we continue to draw on this to further elucidate FCRN biology and how best to modulate it. We believe our science-based approach will remain a powerful tool as we engage with our key stakeholders. Beyond the goodness of our launch, we have had other accomplishments this year across our F-Gratigma program. Our ambition is to reach many more patients suffering from autoimmune diseases through our sub-Q product launch and label expansions. Slide five, in March, we delivered positive phase three data from our ADAPT sub-Q trial. Recall that we had to show non-inferiority of sub-Q to IV based on IgG reduction and meet safety database requirements. We have accomplished both, putting us firmly on track to file the BLA by end of the year. Slide six, in May, we announced positive phase three data from our advanced IV trial. we met a very difficult primary endpoint in a highly refractory ITP patient population. In ITP, Avgatigamot showed a consistent response profile, as we've seen in other indications, a fast onset of action and patients with sustained responses who were able to switch to every-other-week dosing. We have gotten feedback from physicians on the data, and continue to hear about the importance of the IWG score in how they treat patients. We saw a 51% response rate on the IWG scale, where patients had to show a sustained platelet count over 30,000, and in the absence of any bleeding events, for two separate consecutive weekly visits. Day-to-day profile of VivCard in this chronic dosing setting was also consistent with previous clinical trials. Slide seven, we promised that we would look at key learnings from advance and apply them to our ongoing advanced sub-Q study. We did this and have made a database decision to adjust our powering assumptions and expand enrollment in the SC trial. This pushes the timing of top-line data to the second half of 2023, which we believe is in the best interest of ITP patients. We are set up for a very busy 2023. We expect top-line CIDP data in the first quarter and PV and ITP data in the second half. Before I turn the call over to Carl for our financial results, I want to briefly talk about OncoVerity on slide eight. We announced this morning in our press release that we decided to take the company creation approach to advance development of fusotuzumab in the AML patients. Here is why we think this is the right decision for us, for the drug, and for patients. We have the unique and exciting opportunity to take the novel translational biology insights from Dr. Clayton Smith at the University of Colorado and combine them with our first-in-class asset, Cusatuzumab. Dr. Smith and team, have uncovered important insights on the role of the CD70-CD27 pathway in AML, and more specifically in venetoclax non-responsiveness or resistance, which we think will complement the encouraging data we have already demonstrated in newly diagnosed AML patients unfit for chemotherapy. We believe the data we have shown to date warrant further development of Cusartuzumab, and through OncoVerity, This work will happen in an organization that has the expertise and the bandwidth to devote the right time and resources to this opportunity. This is the best decision for EML patients. OncoVarity is also the fourth company to emerge of our discovery engine, where we have built a company around the promising assets while taking a stake in the development. This strategy requires minimal financial commitment and allows us to maintain significant value creation potential for our shareholders. Between our commercial launch, our progress in R&D, and our commitment to immunology innovation, we are off to a strong start for 2022. Our focus going forward will be about continued execution and sustained growth and expansion. With that, I will turn the call over to Carl. Thank you, Tim. Our first half and second quarter 2022 results are detailed in our press release from this morning, so I will only highlight the key points here on slide nine. For the second quarter, our global net product revenues from the WebCard launch were $74.8 million, which includes $1.5 million from Japan and some named patient sales from Israel. Together with the $21 million from the first quarter, this puts our year-to-date global product revenues at $96 million. Inventory in the channel at quarter end was well managed and reflects less than two weeks' worth of hours. Total revenues for the quarter were $85.2 million, which also includes $10 million in collaboration revenue and other operating income. Cost of sales for the quarter were approximately $5 million. Total R&D and SG&A expenses for the second quarter were approximately $126.9 million and $127.8 million, respectively. These can mainly be attributed to FCAR TIGIMOD and other pipeline research expenses, as well as marketing and headcount expenses related to our global launch. On our cash, we ended the second quarter with $2.6 billion in cash, cash equivalents, and current financial assets. This includes net proceeds of $761 million from our March financing. We continue to believe that our net cash burn this year will be up to $1 billion, which will specifically support the rollout of our global launch clinical development of F-card tigimod in 10 indications and organics 117 in 2 indications, investment in the global supply chain, and pipeline expansion through our immunology innovation program. Our business plan is an ambitious one, so we were very happy to be able to bring in the additional capital earlier this year to sustain our ability to drive considerable value for our shareholders. You can find additional details behind these numbers in the press release we issued this month. I'll now hand the call to Keith for a commercial update.