Turning to cash flow and return of capital, $56.1 million of cash was generated from operations in the quarter and our net investment in capital expenditures was $9.6 million. In the first quarter, we continued to build on our leading position in the small to midsized Specialty segment. Yeah, Andy, thanks for the question. The companys 10-K for fiscal year 2022 identifies certain factors that could cause the companys actual results to differ materially from those projected in the forward-looking statements made during this call. We also continue to evaluate additional potential combination opportunities with novel agents. It is well established that these cells contribute to an immunosuppressive environment in these tumors. And congrats on a nice start to the year. Please go ahead. And you'd expand that to go through 2023 as well, it's not a kind of a when [inaudible]. As you heard from Chuck earlier, the double-digit growth was broad-based throughout this segment with spatial biology accelerating at high teens organic growth and our exosome diagnostic prostate test really now in hyper growth mode, with a Medicare reimbursement and COVID headwinds behind it. These values reflect our increasingly diverse, inclusive and equitable culture, which continues to fuel our growth and success. Important clinical updates for XL092 at EORTC and XB002 at ENA highlight recent progress to lay the foundation from moving these compounds into late-stage development. Was there another question? To ensure this doesnt happen in the future, please enable Javascript and cookies in your browser. Can you talk about what we should be looking for in the STELLAR-002 data at SITC as you build on the expectations that were set with the initial STELLAR-001 data you presented at ESMO? I also mentioned that there has been choppiness over the last year or so going from $8 million to $17 million in any given quarter. Moving onto the performance of our proteomic analytical tools, where we also faced a challenging year-over-year comparison as the business grew over 25% in the same quarter last fiscal year. I am exceptionally proud of the talent within the Hanover and our employees drive to make a difference in our industry for the benefit of all our stakeholders. From a fixed income portfolio valuation perspective, this was a particularly impactful quarter due to the sharp increase in rates. Select historical financial information for 2019 through 2021 is available in the Investors section of our website, along with a supplemental presentation on our new reporting segments and additional descriptions and definitions. Our portfolio of proteomic research reagents and analytical tools are critical components of scientific research, are key to unlocking the full promise of the proteomic revolution currently underway, and are positioned to enable the oncoming bio-wave of cell and gene therapies. Just if you could provide an update, and when do you think that options agreement could materialize? Dose escalation continues in the once weekly cohort, and cohort expansion is ongoing at 45 mg per meter squared in the three consecutive days every three weeks cohort. I'm just trying to think about the longer term profile of revenues as we go through the balance of the decade with the decisions that you're making now in the BD front? If you have an ad-blocker enabled you may be blocked from proceeding. Sairopa is developing a monoclonal antibody, ADU-1805, targeting SIRPalpha, one of the ligands for CD47. As commented, we're still really in dose escalation on one of the schedules, which is the once weekly schedule. And how do you think about the potential of this antibody in other cancers outside cervical, for example, perhaps where TF may be expressed? and/or cause actual results to differ materially from those anticipated. So Asthika, from a gross to net perspective, as I mentioned on the call, we came in around 26.1% for Q3. This represents an expansion of our approach to addressing the myeloid macrophage component of the tumor microenvironment. So between various businesses and also accident years, there was no particular business that squeezed a lot of it out. Yeah. But we do hope to initiate that one by the end of the year. We have the ability to take the asset on. We look forward to evaluating this novel combination across multiple solid tumors. Access Roche's financial and non-financial reports for the latest updates on Roche's performance. Definitely had some pull forwards there. The next question will come from Do Kim with Piper Sandler. Sjgren's syndrome is an autoimmune disease that is often undiagnosed and misdiagnosed with an estimated 4 million Americans currently living with the condition, but 2.5 million undiagnosed. What we saw in the 9ER trial is patients -- PFS of the ballpark of a year and a half. I guess, first question for me, if you could just kind of speak to maybe the balance of the R&D spend step up in the full year guidance sort of beyond the funds you indicated for the two deals announced today. We are still on a track--we added 300 people net last year, Id be shocked if we didnt add 300 net this year, to be honest, so. Obviously, we'll continue to monitor closely for dose-limiting toxicities before we establish a recommended phase 2 dose. Thank you, operator. This decrease in gross to net deductions in the third quarter 2022 is primarily related to lower PHS, Medicare Part D and co-pay assistance. With regards to looking forward, I think Europe is still the biggest question mark. And so we -- as I mentioned on the prepared remarks, too, that was -- that decline was really driven by lower PHS, Medicare Part D and then also co-pay assistance. Dose escalation is ongoing for the combination of XB002 with nivolumab, and we expect to initiate dose escalation in combination with bevacizumab before the end of the year. However, our differentiated distribution approach enabled us to stay focused on the superior opportunities presented by our product offerings and consolidation efforts. Got it. XB002 very encouraging signal, no neuropathy or bleeding events, very, very -- after a great start. Thank you. The 10-K as well as the companys other SEC filings are available on the companys website within its Investor Relations section. Sairopa is really more of a best-in-class opportunity. But you know, SPD is good, and were going after it eventually, more pathology with automation, and theyre not the only game in town at Akoya. We recently expanded our RNAscope portfolio with the launch of new automated co-detection assays specifically designed for the Roche Discovery Ultra platform, enabling simultaneous detection of RNA and protein on the same tissue section. We continued to drive healthy price increases of 9.7% across our Core Commercial Book with rate up 6.3% for the quarter and retention near record levels. So we do look forward to these results, which as I said will be -- we'll have in hand before the end of the year. And we are highly confident that the strong foundation we have built, coupled with the continued execution of our long-term strategy will result in strong, sustainable financial performance enabling us to deliver enhanced returns to our shareholders in the quarters and years ahead. In this market environment, it is more important than ever to have a well-diversified book of business with risks deliberately spread by geography, product line and market segments. On U.S. and ex-U.S. expansion, so from a U.S. perspective, as Vicki talked about we're expanding in King of Prussia and we'll eventually have a larger building there with both office for the development organization and other G&A type organizations, but also labs for discovery. Please go ahead. The numbers are going up dramatically. Please go ahead, ma'am. However, I could share with you that more than 70% of our business comes from key Hanover agents that have large relationships with our Core Commercial business. Also during Q1, we returned capital to shareholders by way of $19.6 million in stock buybacks and $12.5 million in dividends. But first, Id like to highlight the corporate sustainability report we recently issued, which details the significant progress we continue to make advancing our environmental, social and governance initiatives. In addition, we are leaning into our agency partnerships and organizational agility to make the necessary pricing and property valuation adjustments, while maintaining stability in our book of business. The data showed how Maurice Flex addresses the labor intensive and time consuming challenges of using legacy methods, including ion exchange chromatography for fractionation. Peter, I hope you're feeling OK. We have followed the Global Reporting Initiative (GRI) G4 guidelines since 2014, and have transitioned to the GRI Standards in 2017. Moving to investment performance; our net investment income was $76.9 million for the quarter, in line with the prior year as both periods benefited from similar levels of strong partnership income. Fixed income securities and cash represent 85% of the total $9 billion portfolio. I will cut to the chase right now about September was strong, October is remaining strong. developments. You talk about exosome as a platform that could be a billion revenue unicorn. It is very lumpy still - we dont have a lot of large, large customers, and there was some timing in some of that, and Wilson Wolf has seen some of that as well, as well as issues around clinical and finding patients, so things have softened a little but still more or less on track for what our schedule was for them. Thank you for joining us for our first quarter conference call. Great. Listen, we are quite proud of the fact that our team is remaining very disciplined on our rate and overall pricing in Core Commercial. But I think on a case to case basis, our view is that the overall approach with CBX-12 gets us into a game, if you will, that allows us to target any tumor potentially without having to have an address as you would normally see with an ADC. OK. Great. Any comments you could share on the next indications you intend to pursue in the pivotal study? We have been looking at a lot of late pre-clinical early clinical deals and we're going to continue to do that. So yes, strong, proteins for sure, antibodies for sure, assays for sure. The next question will come from Peter Lawson with Barclays. Its the best its ever been both here and the U.S., and our teams--and believe me, weve had some very detailed, we call QBRs, our quarterly business reviews, and theyre adamant that the funnel and the pipeline looks great and demand is solid. We continue to penetrate the burgeoning cell therapy opportunity with our portfolio of GMP proteins and are seeing continued momentum in the regenerative medicine, or regen med market. Prescription trends remained strong in Q3 2022. But there just has to be that confluence of us having feeling as a solid scientific rationale, compelling clinical data have been generated to date, there's a good clinical and commercial future for the asset. We have an option to license CBX-12 after reviewing the totality of the data from the completion of the ongoing once-weekly dose escalation trial, four phase 1b monotherapy expansion cohorts of about 40 patients in each major solid tumor type at the recommended phase 2 dose and completion of a dose escalation combination cohort with pembrolizumab. If theyre not growing, theyre going to need less people. Initial tumor biopsy assessments show delivery of CBX-12 and exatecan into the tumor. So in general, we look broadly at a lot of things, small molecules and biologics. Are you in charge of the data release or is that a Roche decision? I would like to I am sorry, we still have one more question that just popped in and that is from Bob Farnam with Boenning and Scattergood. Sure. So we think that that sort of choppiness will continue going forward in future quarters. In the case of the BI antibody, patients must be homozygous for the V1 allele to enroll in their currently recruiting clinical trials. [Operator Instructions] Our first question comes from Matt Carletti with JMP. Please go ahead, sir. Bio-Techne Corporation (NASDAQ:TECH) Q1 2023 Earnings Conference Call November 1, 2022 9:00 AM ET, Chuck Kummeth - President, Chief Executive Officer, Jim Hippel - Executive Vice President, Chief Financial Officer, David Clair - Vice President, Investor Relations. So I am just kind of curious what we should expect from that line? Can you just talk about the margin cadence as we work our way through the year here? Youre reading a free article with opinions that may differ from The Motley Fools Premium Investing Services. Were seeing strong performance here early in October, but obviously the macro picture there is a bit cloudy for everyone, and thats something were keeping our eyes on that could--you know, that would be the one flag that could deter us from achieving double digit, if anything. The team has done an extraordinary job strategically implementing price increases across the portfolio to offset the impact of inflation. For CONTACT-01, the phase 3 pivotal study sponsored by Roche, which is evaluating cabozantinib in combination with atezolizumab versus docetaxel in patients with metastatic non-small cell lung cancer who have been previously treated with an immune checkpoint inhibitor and platinum-containing chemotherapy, the final analysis of the primary end point of overall survival is on track to occur before the end of this year. Thanks Dave and good morning everyone. Great. All participants will be in listen-only mode. Ellas wide dynamic range and high precision ensures users get the high quality data required to meet regulatory standards for AA titration throughout bio-protection workflows. [Operator Instructions] The next question is from Grace Carter with Bank of America. About six things: multi-variable, theres a bunch of things I wont get into, but we can one-on-one, so weve got a strong hopper. Cabo franchise revenue grew 39% year over year compared to third quarter 2021, marking its eighth consecutive quarter of growth. In North America, consistent execution across the portfolio drove low double digit revenue growth for the quarter, driven by a continued strong bio-pharma end market. Then maybe just thinking--taking that commentary and then applying it to the expense growth that youre expecting for the year, how are you thinking about hiring, and then also has the employment market eased up here a bit or is it still pretty tight for talent? Thank you. Europe is improving, but how could it not improve, so. We have our next question from the line of Patrick Donnelly with Citi. How you think about that increase in exposure and what might act as rate and what might act as kind of increased exposure in the true sense? It is getting better, as you commented and you asked about, much better. Thank you very much. We achieved the 15.7% operating return on equity and operating earnings per share of $3.26. Prior year reserve development was favorable in the quarter by $6 million, stemming from Specialty and Core Commercial. We have the next question from the line of Dan Leonard with Credit Suisse. So we are very much talking to our franchise agents, but we are doing it in a more kind of specialized expert-to-expert experience. During the quarter, we drew down approximately $100 million on our line of credit to fund the Namocell acquisition, which was partially offset by applying the proceeds of our ChemoCentryx investment sale to our debt balance. In response, we remain thoughtful in our underwriting philosophy and pricing actions and certainly in our prudent reserving processes. In view of a more sustained inflationary environment, we have now accelerated our rate actions, filing rate increases in nine states in Q1 and Q2, representing 70% of our homeowners premium. It's come down as you -- as we've come through the year, it was higher in Q1 and come down in Q2 and come down in Q3. And I would assume that the next steps would be similar to what Cybrexa communicated, which was a phase 2 ovarian breast and non-small cell lung cancer as next steps, but just curious if you can elaborate there. Since normal tissues have low or no expression of the selected target, they do not take up the payload, minimizing side effects. But importantly, in a sort of tumor target agnostic way, you don't need to express a particular tumor target in this case, which means they could be broadly applicable as a platform. Please go ahead. SG&A expense was the primary driver of the decrease in total operating expenses, which was primarily related to lower legal and employee-related expenses. And I think in some ways, may be outperforming the market, because of the discipline that we are showing and maintaining very high retention ratios, while we push for that rate. Thanks, Vicki. Now turning to progress on our pipeline molecules. Just wondering when you can expect the next update on the dose escalation. Our agreement with Sairopa provides us with another potential way of addressing this potentially impactful mechanism of action. With that overview, I'll now discuss our first quarter financial highlights and recent business performance, starting with Core Commercial. PDF. Test volume in our ExoDx Prostate, or EPI test increased over 70% while associated revenue grew over 100% in the quarter. Hey, it's Mike. I know you just spoke to Dan about the European summer vacations, but do you think any of the weakness there in the bulk purchase side is just related to just being less dollars out there for biotech projects? In keeping with our prior strategy, we continue to take a measured approach to renewals, protecting profitable business while pricing new business more fully. They did present a little bit of data that was encouraging, certainly showing pretty reasonable free exatecan levels in some tumor biopsies. You can look back 10 years and say we said so. Moving onto the diagnostics and genomic segment operating margin at 12.4%, this segments operating margin increased 20 basis points compared to the prior year. I think if you just think of most competitors are suggesting that they have kind of a high watermark in their renewal retention rates and then some of the more distressed business is making its way into the E&S market. They are helping more out, the whole scale ready team, from a proteins point of view because were going to be adding more and more proteins to our factory. Collectively, our RUO reagents grew nearly 30% in Q1 last year, again highlighting how difficult this quarters comp was. Theyjust revealed what they believe are thetenbest stocksfor investors to buy right now and Exelixiswasn't one of them! Thanks for taking my questions, and congrats on the quarter. So I just wonder if you could expand on it without giving too many of the secrets away. For CONTACT-02, our phase 3 study in combination with atezolizumab in metastatic castrate-resistant prostate cancer, we are projecting that enrollment will be completed in the first half of next year. We look forward to having the opportunity pending data and approval to bring CABOMETYX to many more patients in need of additional treatment options. There's no well defined standard of care. I think were still looking at near the end of Q3, in that range, so. Just a couple of questions, simple ones here. Its a great example of things we can launch and get out there. I think what was actually encouraging there is if you looked at the data, you would've seen that the partial response in breast was actually on the once weekly dose schedule. What would that be based on -- what kind of clinical data might you consider encouraging enough for you to advance that acquisition? Before we begin, let me briefly cover our Safe Harbor statement. I think really what it would come down to is the specific details of the toxicity profiles of the competitive environment, so to speak, or the standard of care in that particular setting. Tumor-associated macrophages, along with other myeloid cells, represent a significant and often major component of the solid tumor microenvironment and is prominent in tumors such as colorectal cancer, ovarian cancer, hepatocellular cancer, renal and breast carcinomas, for example. We've been very prudent with our loss picks over the last year plus just to make sure that the profitability - reduced rates that people are getting what that we are prepared for. It is interesting that we have a double-digit quarter in our diagnostic reagents division but there are no questions. So our view is, we're doing BD on a pretty aggressive scale based upon the conviction we have in the asset pool that's available broadly within oncology, small midcap biopharma. Adjusted SG&A in Q4 was 27.3% of revenue compared to 25.1% in the prior year, while R&D expense in Q1 was 8.9%. Yeah. So it is an important area of unmet need. In addition, the stability of the attached payload varies between ADCs with liberation of free payload contributing to our adverse events. Thats the big event waiting for the rest of the big guys out there in insurance. Our combined ratio, excluding catastrophes, improved 1.1 points to 88.9% from 90% in the first quarter of 2021. We're happy that things are opened up with regards to offices and medical meetings, etc. So with respect to the overall survival from COSMIC-313 and just sort of a quick reminder on the study design here. And finally, clinical trial sales have historically been choppy between quarters, and we expect this to continue in future quarters. Okay, thats helpful. The next question will come from Chris Shibutani with Goldman Sachs. I wanted to expand on that softness in bulk purchasing that you mentioned, Chuck. Hi, guys. Awesome. This resulted in a meaningful unfavorable change of about $380 million after tax in our net unrealized position. I would say overall, I know our cell and gene therapy and our gene proteins, we didnt have a 50%-plus quarter like wed been doing. Specifically, the grants donations and sponsorship (GSD) data collection process is detailed here. Full-Year ; 9M; Half-Year; Q1; Roche has published its First Quarter Sales results for 2022 prior to the opening of the Swiss Stock Exchange on Monday, 25 April 2022. You guys always give great kind of stats every quarter on kind of pure renewal rate change, as well as premium price change. They wont all be done by us. And then just one other question. Thanks, Yaron. And frankly, even as we build out our technology and our capabilities like our customer service center, all of that is expanding our capabilities for the agents that we have longstanding and large relationships with. Please. The factory the remainder of this year, the fiscal year, were going to add six more products, which by far will be the largest menu out there in GMP proteins for both regen and cell and gene therapy, so thats all a really good story. Thinking about rate in Core Commercial, I was wondering if we could just get kind of any more color on the rate being achieved across different lines of business and I guess just the how you see the gap between the rate being achieved and loss cost trends? Before I wrap up, it's important to acknowledge that we believe it's unlikely many of the headwinds stemming from this unpredictable economic environment will subside imminently. Our team remains highly focused and motivated to compete every day to bring the benefit of CABOMETYX to all eligible patients as we continue to build the franchise and serve patients. We have made significant investments over the years to build our catalog of over 40,000 RNAscope ISH probes available in over 400 species and remain committed to protecting these investments and defending our intellectual property rights in our spatial biology business and more broadly throughout the portfolio. So really looking for maximizing that opportunity and looking for rapid path to registration across multiple tumor types.
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