Replay:
https://edge.media-server.com/mmc/p/osyakame
Let's start with plenty of useful insights during presentation:2 min: Lantheus accelerates growth, diversifies its portfolio, and continues to be the category leader
121.4% Y-to-Y revenue increase for 2022 Q2, led by Pylarify
27 June: in Europe, Curium Announced The Submission Of Its Marketing Authorization Application For [18F]-DCFPyL To The European Medicines Agency
In the US, Curium Initiated ECLIPSE, a Phase 3 Clinical Trial For Its Investigational Lu 177 PSMA I&T
Pylarify will now be included in the vast majority of late-stage U.S. trials for PSMA-targeted therapeutics
Pylarify AI received new FDA clearance, deep learning stuff to detect and quantify patient disease, with one of the largest databases PSMA-PET images in the world, also presented by Jeremie Calais at SNMMI in June
7 min: Recent pipeline advancements => 1095 (enrolment just completed) & NM-01 (phase I presented at SNMMI in June)
"We continue to seek ways to further expand our portfolio, evaluation several opportunities to collaborate, in-licenses or acquire strategic assets that match our priorities. We are particularly focused on late-stage diagnostic therapeutic product opportunities in oncology that complement our existing portfolio."
"In addition, early stage opportunities also aligned with our strategy that drive our pharmacist business. For example, we recently entered into a collaboration agreement with Radiopharm Theranostic. Radiopharm is an Australian-based developer of a platform of radiopharmaceutical products, for both diagnostic and therapeutic uses. Radiopharm plans to initiate a phase I therapeutic trial for patients with PD-L1 positive non-small cell lung cancer (NSCLC) in Australia. Lantheus will supply our diagnostic product candidate NM-01, to Radiopharm for their clinical trial, to be used as a clinical research tool to detect PD-L1 expression in patient selection. We have also retained the option to extend our partnership for the rest of Radiopharm pipeline."
10 min: Paul Blanchfield has been promoted to Chief Operating Officer (COO) in June
11 min: Operational update by Paul Blanchfield
Net sales of USD $130m for Q2 vs. 93m Q1.
US geographic footprint expanded, with the addition of 4 additional PET Manufacturing Facilities (PMFs): New York, West Virginia, Colorado, Florida, where they had previously flying doses
Agreement reach with a key PMF partner to double the number of PMF and extend the partnership through 2027 = enhanced capacities
Adding new customers: hospitals, image centers, government facilities > now 900 customers across 45 states actively ordering, vs. 700 last quarter, even with the availability of competitive PSMA agents on the market
Several commercial payers, including Humana, Aetna, Anthem, Blue Cross Blue Shield, have updated their policies to reflect an agnostic approach to the choice of imaging agents
These advancements, combined with USD $130m of sales this quarter, speak to the clinical benefit of Pylarify, its scalable manufacturing network, and our operational capabilities
We continued to install Pylarify AI at leading institutions and incorporate it into PSMA-targeted therapeutic trials
15 min: key takeaways from investor presentation in May
First-mover advantage for Lantheus
We believe that TAM could increase by another 100'000 scans from its existing 250'000 scans that we highlighted in April, from two primary areas:
1. we believe there could be additional scans for metastatic resistant cancers in the 1st and 2nd line, and for which PSMA therapeuties are currently being studies
2. PET scan imaging may expand over time, due to change in regulations and intermediate population
This would take TAM to $1.5 bn USD, vs. 1.1 as of today, according to our forecasts.
19 min: financial update by CFO
25 min: Key Takeways by Mary Anne Heino
Pylarify solidified as THE PSMA PET imaging agent of choice for the US prostate cancer community
Now the Q&A including some unfriendly comments addressed by President & CEO Mary Anne Heino to Telix:
Question (Analyst): considerations regarding the expanded TAM forecasts
Answer (Paul): our assumptions based on per patient per scan basis, by physicians and so on, and increasingly in the therapeutic space Physicians and guidelines will continue to catch up.
Question (Analyst): with regards to the revenue guidance, given that you have so much capacity, and new PMFs online, is there any reason why that not would continue to step up sequentially?
Answer: you know, the maths demonstrate that it should be sequentially improved, if I look at the first half of the year vs. total second half, in terms of Pylarify revenues, I show that it should be 20 to 50% greater, but you know, there's still competition, that is just entering the marketplace at this juncture, you know, SMALL, but still competition that is there, and we will continue to make sure that we watch the marketplace [...] anyway last year we were at $42m USD and now Pylarify is going to account for up to $500m of our revenues so, we're very pleased where we're going.
Question (Analyst): and also you mentioned that you have another competitor, that is like more residual in the marketplace, with the gallium radioisotope, how do you update your guidance for competition/what do you seek in the market now that, you know, they are out there and have some reimbursment.Answer (Mary Anne): so we want to continue to see is adoption of the PSMA based tech imaging, that is the wonderful innovation that has been brought to the prostate cancer community, and where our focus has been. Anyone who knows me knows that my typical approach to doing things, I'm talking about Lantheus and the way we are doing things, but I'm going to step aside for a moment here, and talk about competition here because I think it's important, I think it's important that accurate information be offered out to the analyst community but also to shareholders for making decisions.
So I'm going to correct what I think is some fairly inaccurate information that has been said into this market eval. One of the reasons that has been the entrance of the two Ga 68 PSMA-11 agents. So we all know there has been four Ga 68 PSMA-11 agents in the market. Two of them were the academic, they have been approved in late 2020, or they were approved prior to 2020, and they're kinda geographically restricted. More recently, we have to approved PSMA 11 agents and ONE OF THESE TWO COMPANIES HAS BEEN FAIRLY VOCAL AND PUBLIC IN CLAIMING THAT THEY HAVE HAD A MORE SUCCESSFUL LAUNCH EXECUTION THAN PYLARIFY. So I'm just gonna take a look into that.
This is a company for whom (TELIX??) their product MISSED its original launch date by 3 months, and then if you look at what happed post-approval, what was finally the late-approval and you look at revenue proceeds, GENERATING NO REVENUE, its first full quarter on the market. And this was to be compared with PYLARIFY's first quarter on the market for which we generated revenue and reported USD $7.4 million of revenue. For the second quarter, PYLARIFY reported USD $35.4 million of revenue.
This other product (ILLUCCIX??), even though it was, I'd say, RIDDDDING THE WAAAAAAVE (note: she insists on WAAAVEEES with an ironic tone again), OF THE MOMENTUM THAT HAS BEEN BUILT BY US (note: LANTHEUS), with PSMA market, has coming to report USD $13 million (note: it's definitely Illuccix then...).
So I'm GOING TO STAND FIRM ON WHAT REPRESENTS A SUCCESSFUL LAUNCH AND TAKE THAT VICTORY AND TAKE THAT CLAIM FOR LANTHEUS. THE SALES NUMBERS AND EVERYTHING ELSE THAT WE'VE DONE IN THE MARKET, AS FAR AS BUILDING OUR CAPACITY, AS FAR AS BUILDING MARKET ACCESS, PUTTING TRUST AND BUILDING AWARENESS, I'm going to say we feel terrific about it, and for what it has done for patients and physicians in making this product available.
(20min delay)