Global Negative Pressure Wound Therapy Market with Covid-19 Impact Analysis | Industry Business Outlook, Revenue, Trends and Forecasts 2024 – Owned

Global Negative Pressure Wound Therapy Market Analysis to 2024 is a focused and comprehensive study of the Negative Pressure Wound Therapy industry with a focus on the global market trend. The information mentioned in the Global Negative Pressure Wound Therapy Market research report presents an overview of the latest trends observed in the global market. Besides, this report emphases on the latest events such as the technological developments and the product launches and their consequences on the Market. The research report delivers the global market revenue, parent market trends along with market attractiveness per market segment.

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Top Players of Negative Pressure Wound Therapy Market are:

Acelity (KCI) Smith & Nephew Cardinal Health Devon Medela Triage Meditech WuHan VSD Talley Group Regional Negative Pressure Wound Therapy Market (regional production, demand and forecast by country):

The main goals of the research report elegant the overall market overview on Negative Pressure Wound Therapy market dynamics, historic volume and value, robust market methodology, Latest and future trends, Porters Five Forces Analysis, new technological development, cost structure, government policies and regulations, etc. Major companies, company overview, financial data, products and services, strategy analysis, key developments market competition, industry competition structure analysis, SWOT Analysis, etc.

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KEY MARKET SEGMENTS

On the basis of types, the Negative Pressure Wound Therapy Market is primarily split into:

Conventional NPWT Devices Disposable NPWT Devices On the basis of applications, the Negative Pressure Wound Therapy Market covers:

Hospitals Clinics Homecare

Which market factors are explained in the report?

Study Coverage:Covers significant companies, vital market segments, the scope of the products offered in the global Negative Pressure Wound Therapy market, the years considered and the study objectives.

Executive Summary:It contains a summary of the most important studies, the Negative Pressure Wound Therapy market growing rate, modest conditions, market drivers, trends and problems as well as macroscopic indicators.

Production by region:This Negative Pressure Wound Therapy report provides information on imports and exports, production, sales and key players in all examined regional markets.

Manufacturer Profile:Each Company defined in this section is screened based on a SWOT analysis, products, value, their capacity and other important factors.

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Table of Contents

1 Negative Pressure Wound Therapy Market Overview

2 Global Negative Pressure Wound Therapy Competition by Manufacturers

3 Global Negative Pressure Wound Therapy Capacity, Revenue (Value) by Region)

4 Global Negative Pressure Wound Therapy Supply (Production), Export, Import by Region

5 Global Negative Pressure Wound Therapy Market Revenue (Value), Price Trend by Type

6 Global Negative Pressure Wound Therapy Market by Application

7 Global Negative Pressure Wound Therapy Company Profiles

8 Industrial Chain, Sourcing Strategy and Downstream Buyers

9 Negative Pressure Wound Therapy Market Effect Factors Analysis

10 Global Negative Pressure Wound Therapy Market Forecast

11 Research Findings and Conclusion

12 Appendix

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Global Negative Pressure Wound Therapy Market with Covid-19 Impact Analysis | Industry Business Outlook, Revenue, Trends and Forecasts 2024 - Owned

The fight to end intersex surgeries at a top hospital took a deep toll on activists – PBS NewsHour

This story was published by The 19th. You can find the original article here.

Eugene Robinson recovered from his double mastectomy on a hospital porch in Durham, North Carolina. It was August 1956, and as a Black child in the Jim Crow South, Robinson wasnt allowed to heal next to White patients.

Sarah Robinson, Eugenes mother, brought a daughter to the hospital. She returned home with a son. It was his third of four surgeries. Two of his nine siblings had undergone similar operations, but his relatives never talked about the fact that androgen insensitivity syndrome, a genetic intersex condition, ran in the family.

Nearly 65 years later, Sean Saifa Wall, 41, sifts through Robinsons medical records, looking for answers about his uncles story that might shed light on his own. Wall, like Robinson, is intersex.

Intersex is an umbrella term for people with variations in sex characteristics that dont fit neatly in the binary of male or female. Some intersex people are born with varying reproductive anatomy or sex traits some develop them later in life. About 1.7 percent of people are born intersex, according to a 2000 report by Dr. Anne Fausto-Sterling.

A letter discusses the various surgeries performed on children in the Robinson family. Eugene Robinson had four intersex surgeries as a child. THE 19TH/KATE SOSIN

Since the 1960s, medical convention has been that intersex variations should be corrected, often through a combination of painful surgeries and hormone therapy starting from infancy or before a child can consent. But on July 28, the Ann and Robert H. Lurie Childrens Hospital of Chicago became the first hospital in the United States to suspend the operations. The news comes after a three-year campaign against the hospital led by Wall and Pidgeon Pagonis, co-founders of the Intersex Justice Project.

Activists have been protesting intersex surgeries since 1996, when a group demonstrated outside the American Academy of Pediatrics convention in Boston. Since then, the UN has condemned the surgeries which remain legal in almost every country in the world as irreversible and unnecessary procedures that can cause permanent infertility and lifelong pain, incontinence, loss of sexual sensation, and mental suffering.

Wall knows that pain intimately.

Wall came out as gay at age 14. Then, he came out as transgender. In both cases, his mom lost it, he said. She was like, why do you want to wear mens clothes, mens underwear?

But Walls oldest aunt reminded his mom about his intersex uncle, now deceased. His aunt said do you not remember playing with Queen Esther as a child?

And my mom was like, Whos that? And shes like Thats Gene.

Wall says the memory blew my moms mind for seven years she had a sister. Looking back, she did remember Esther.

Eight of his family members were intersex, Wall says. The more that Wall started to talk about himself, the more his family opened up about their own histories.

Up until the time he was 13, Walls mom resisted doctors insistence that he have surgery to remove undescended testes, he says. She saw his older intersex siblings suffer through their own operations and thought they were unnecessary.

They told my mom that the testes were cancerous, Wall said. So his mom agreed to the surgery. Wall never had cancer.

He had spent two years under the care of a doctor that he says studied him, asking him questions about whether or not hormones made him less gay. Still, it wasnt until college, while doing a Yahoo internet search, that Wall pieced together that he is intersex.

I was so angry, he said. I was like, Oh, this is not fair. Its not right. I didnt talk about it for a while. I would tell people here and there, but I didnt talk about it publicly because I had so much shame.

I would tell people here and there, but I didnt talk about it publicly because I had so much shame.

When he was 25, he started taking testosterone, something he wanted to do as a trans person to confirm his gender. But he wasnt metabolizing the testosterone the way most people on the hormone do.

I think I felt really suicidal, he said, referring to people constantly misgendering him. But I knew that if I took my own life, that no one would ever know what happened to me, and no one would ever know my side of the story.

Thats when Wall decided to start organizing for intersex rights.

For 19 years, Lurie patient Pidgeon Pagonis also believed they had survived ovarian cancer. The surgeries and exams started before Pagonis could remember, at 6 months old. They had another operation when they were 3 or 4 years old, and another when they were 10.

Since I was like 11 they would always just lift my shirt off, touch my chest and then pull my pants down and look at my vulva area, Pagonis recalls. And then theyd ask me questions like, How are you? How are your grades?

Pagonis thought that because of the cancer, they would never be able to have a baby. In truth, Pagonis never had cancer. Years of intersex surgeries to make their body conform to the idea of the female sex had left them unable to feel most sexual sensation.

They spent 18 years in and out of Lurie for surgeries, hormones and exams. Doctors would ask Pagonis if they had questions. Pagonis wanted to know why they were experiencing puberty differently than other kids.

I didnt know I had a vaginoplasty, and I didnt know I was intersex, Pagonis said. I did not know I had a castration, and I did not know I had a clitorectomy at that point. I thought I survived cancer.

Pagonis attended college practically in the shadow of the hospital at DePaul University, watching doctors come and go as they studied for finals. It wasnt until they learned about intersex issues at DePaul that they realized that all those visits to Lurie hadnt been about cancer at all.

I just thought these were my doctors that I had to go to because I had cancer when I was a kid, Pagonis said. And also, I was so unlucky that I had this urethra problem.

No other major U.S. hospital has ever stated that they dont perform intersex surgeries, so Lurie was far from the only institution performing such procedures. However, Lurie has enjoyed a sterling reputation among LGBTQ+ people since 2013, when it opened one of the first pediatric gender clinics in the nation under the leadership of Dr. Robert Garofalo, a nationally-renowned expert in transgender health. Under Garofalos leadership in the Gender & Sex Development Program, Lurie became the first hospital in the United States to adopt a trans-inclusive policy for its young patients.

That prestige made Lurie a prime target for a campaign to end intersex surgeries. Intersex activists have long pointed to a disconnect between the gender-affirming care for trans and non-binary youth at the hospital and surgeries done on intersex children without their knowledge or consent.

The truth of the matter is they are very distinct and separate populations in many ways, said Garofalo. But there are areas where there are some overlaps.

And those cast a pall on the gender clinic as calls to end the surgeries overwhelmed its social media channels.

The Intersex Justice Project Pagonis and Walls organization of intersex activists of color led its first protests against Lurie in 2017 and again in 2018, when the Androgen Insensitivity Syndrome-Differences of Sex Development Support Group held its conference in Chicago. About 70 people showed up to protest outside Lurie. Since that time, Lurie has been the target of a relentless campaign to end the surgeries, and protests outside the hospital have only grown.

In July, Pose star Indya Moore excoriated the hospital for using their image to promote LGBTQ+ inclusion. You cannot stand W/ trans ppl & step ON intersex ppl! Moore wrote on Twitter. The tweet set off a firestorm of bad press for the hospital as an old petition against the surgeries at Lurie racked up 45,000 signatures.

Pidgeon Pagonis, the co-founder of the Intersex Justice Project at a protest in 2017. SARAH-JI, INTERSEX JUSTICE PROJECT

Garofalo said the hospital has long been revising its polices on intersex care, but it had never apologized for the harm those surgeries had caused.

I mean, the truth of the matter is that it has been uncomfortable for me at times, conceded Garofalo, who does not oversee intersex care at the hospital.

On July 28, the same day the hospital announced it was suspending the surgeries, the hospital apologized.

We empathize with intersex individuals who were harmed by the treatment that they received according to the historic standard of care and we apologize and are truly sorry, the hospital stated in a letter signed by President and CEO Dr. Thomas Shanley. When it comes to surgery, we are committed to reexamining our approach.

A number of staffers within Lurie pushed for an end to the surgeries, most notably transgender research coordinator Dr. Ellie Kim, who publicly criticized the practice.

I really owe Ellie a debt of gratitude for really stepping forward and not being shy about her thoughts on the matter, Garofalo said. And to that extent, Im really proud to be where Im at.

Luries end to intersex surgeries marks a watershed moment for intersex rights. Lurie is ranked among the top pediatric hospitals in the nation, and intersex rights activists hope that other hospitals follow suit.

Lurie is ranked among the top pediatric hospitals in the nation, and intersex rights activists hope that other hospitals follow suit.

But for advocates like Wall, the campaign has also taken a deep toll. Pagonis and Wall garnered support and educated the public by sharing intimate personal stories. Its largely considered disrespectful for reporters to ask transgender people about their surgeries or genitalia. Intersex activists dont have that luxury yet, says Hans Lindahl, director of communications for youth intersex organization InterAct.

Something that we say a lot is that we have not yet had our Laverne Cox moment, said Lindahl. Were still so under the purview of being medicalized that I think theres a pressure that we almost have to tell these stories at this point in our movement in order to get people to listen.

For Pagonis and Wall, that has meant revealing details about their own traumas, sexual experiences, anatomy and family histories.

And largely lost in this moment is the history of intersex surgery itself. Intersex operations were born out gynecology, a practice developed by James Marion Sims, who performed brutal experiments on enslaved Black women without anesthesia. Although intersex surgeries were popularized in the 1960s, doctors had been doing them for years before, as Walls family history shows.

Wall says his family was already harassed as a Black family in the segregated South. But a Black family with three kids whose sex characteristics varied meant they were tormented endlessly.

So for me, my intersex story comes out of this legacy thats rooted in the South, thats rooted in North Carolina, Wall said. By the time this intersex variation appeared in my family, there was knowledge and awareness of it, but people didnt talk about it, because there was shame and stigma and secrecy.

See the article here:
The fight to end intersex surgeries at a top hospital took a deep toll on activists - PBS NewsHour

Edited Transcript of CLVS.OQ earnings conference call or presentation 6-Aug-20 8:30pm GMT – Yahoo Finance

Boulder Aug 7, 2020 (Thomson StreetEvents) -- Edited Transcript of Clovis Oncology Inc earnings conference call or presentation Thursday, August 6, 2020 at 8:30:00pm GMT

Clovis Oncology, Inc. - VP of IR

Clovis Oncology, Inc. - Executive VP & CFO

Clovis Oncology, Inc. - Executive VP of Clinical, Preclinical Development & Pharmacovigilance and Chief Medical Officer

* Patrick J. Mahaffy

Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director

RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research

Ladies and gentlemen, thank you for standing by, and welcome to the Clovis Oncology Second Quarter 2020 Financial Results Webcast and Conference Call. (Operator Instructions) I would now like to hand the conference over to your speaker today, Anna Sussman, VP of Investor Relations. Thank you. Please go ahead.

Anna Sussman, Clovis Oncology, Inc. - VP of IR [2]

Thank you, Judy. Good afternoon, everyone, and welcome to the Clovis Oncology Second Quarter 2020 Conference Call. And thank you for joining us. You've likely seen this afternoon's news release. If not, it's available on our website. As a reminder, this conference call is being recorded and webcast.

Our remarks may be accessed live on our website during the call and will be available on our archive for the next several weeks. Today's agenda includes the following: Pat Mahaffy, our President and CEO, will review the highlights of today's corporate update; then Dan Muehl, our Chief Financial Officer, will cover the quarter's financial results in greater detail. Pat will make a few closing remarks, and then we'll open the call for Q&A, during which time, Lindsey Rolfe, our Chief Medical Officer, will also be available to answer questions.

Before we begin, please note that during today's conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans.

All these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.

Our actual results could differ materially due to a number of factors, including the extent and duration of the effects of the COVID-19 pandemic. Please refer to our completion filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made, and Clovis undertakes no obligation to update or revise any forward-looking statements. Additionally, please note that we'll be discussing cash burn, a non-GAAP financial measure, during today's conference call.

Required disclosures related to this are in today's news release, which can be found on our website. Now I'll turn the call over to Pat.

Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [3]

Thank you, Anna. Welcome, everybody. Appreciate your time. All that was new and unfamiliar at the time of our last call has now become all too familiar for most of us as we continue to try to adjust to the new normal. I hope that all of you on the call or webcast are safe and well. I'll also note that we are each of us doing this from home. And you may well hear a dog bark or the sound of the child and from the looks out my window, a thunderstorm. So I apologize in advance for that.

We remain tremendously grateful to the health care professionals on the frontline of this global pandemic. Also want to acknowledge the tremendous effort being made by our investigators and prescribers to maintain enrollment and safely manage ongoing patients in our clinical trials. And for their efforts to continue to prescribe and manage Rubraca commercial patients during the significant upheaval to their clinics and practices during the second quarter due to COVID-19.

And I'll begin with the quarter's commercial update for Rubraca. Last quarter, I described the advantages of Rubraca as an oral oncology treatment in the COVID-19 era, which we believe provides benefit for patients and practices.

Our global net revenue for the second quarter of 2020 was $39.9 million. This represents a 21% increase from Q2 2019 and still up slightly over Q4 2019. In the second quarter, however, it is evident that COVID-19 headwinds negatively affected revenues, largely related to reduced new patient starts due to fewer diagnosis and office visits, as oncology practices and patients adjusted to the impact of the virus in the United States and Europe.

Our sales reps began their virtual efforts beginning in mid-March in the United States, and we continue to adapt our marketing efforts and activities in order to engage with U.S. physicians during this period.

With the resurgence of cases occurring across several large U.S. markets, it is unclear how long access may remain restricted at least regionally. It is important to note that in many territories, our reps are beginning to make some in office visits. And while we hope this becomes more of a trend, predicting the course of this virus, of course, remains very difficult.

In Europe, access to hospitals and clinics was challenging throughout the second quarter and remain so today, although certain countries are permitting more access. When we look at the impact of COVID-19 on U.S. paid new patient starts, we saw no clear trend through May, but we saw a meaningful decline in June. In July, we saw a recovery back toward the previous levels, aided, of course, by prostate new patient starts. We are also seeing positive progress in the EU including our best sales performance in the EU coming in the month of July of this year.

Obviously, the COVID-19 situation remains quite fluid, and it is still too early to declare any trend in either the United States or Europe.

In addition to seeking Rubraca as the maintenance treatment option of choice in recurrent ovarian cancer, we also look forward to establishing Rubraca in the U.S. in advanced mutant BRCA-positive cancer, prostate cancer, which brings us to the third and newest indication for Rubraca in the prostate cancer setting. On May 15, the FDA-approved Rubraca as monotherapy treatment for patients with BRCA1/2 mutant recurrent metastatic castrate-resistant prostate cancer. The approval was based on data from the TRITON2 clinical program in advanced prostate cancer and addresses the approximately 12% of men with metastatic CRPC who have a mutation of BRCA in the tumor.

We commenced an all virtual U.S. launch upon the receipt of this approval. As noted earlier, access to oncology clinics and physicians has been challenging. A different non COVID-19 environment, our commercial team would be leading in person and engaging with the primary clinicians in prostate-focused oncology and urology practices. That, obviously, is not possible today.

Historically, BRCA testing has not been common in the prostate cancer treatment setting. Recent PARP inhibitor approvals and related disease education efforts should ultimately result in greater awareness of the importance of testing and its potential benefits for patients.

One issue affecting our prostate cancer marketing is that our partner, Foundation Medicine has not yet received FDA approval for the companion plasma-based diagnostic for Rubraca. While other plasma-based testings are available, we cannot actively promote them. We are not in a position to remark on the confidential discussions ongoing between FMI and FDA. But our understanding is that FMI is in the later stages of the review process, and they are prepared to launch FoundationOne Liquid CDx so that it will be available to physicians and patients promptly upon FDA approval.

It was very encouraging to see the rapid update of the clinical practice guidelines in oncology for prostate cancer by NCCN shortly after approval, which now include Rubraca as a Category 2A recommendation for patients with BRCA-mutant tumors or mutant CRPC under second line and subsequent therapy.

Now I'll briefly discuss our clinical pipeline for Rubraca and lucitanib as well as our plans for FAP-2286.

On the development front, the effects of COVID-19 in our clinical trial enrollment has been minimal. We, of course, adhere to the regulatory guidance that FDA and other agencies have provided regarding clinical trial conduct during COVID-19, and we are grateful to our clinical teams and investigators who work tirelessly to assure the safety of trial participants and investigators while maintaining compliance with good clinical practice and minimize risk to the integrity of our trials. We successfully completed target enrollment in ATHENA, our Phase III 1,000-patient study in front-line newly diagnosed advanced ovarian cancer maintenance in June. Target enrollment of 1,000 patients was achieved in less than 2 years, and we could not have achieved this milestone without the active involvement of the Gynecologic Oncology Group, or GOG, and the European Network for Gynaecological Oncological Trial, or ENGOT, 2 of the largest cooperative groups in the U.S. and Europe dedicated to the treatment of gynecological cancers, and to them, we are grateful.

The LODESTAR study, our Phase II pan-tumor study to evaluate Rubraca in homologous

recombination repair genes, including BRCA, across tumor types, continues to enroll patients. The study will evaluate Rubraca in patients with recurrent solid tumors associated with a deleterious homologous recombination repair, or HRR gene mutation. Based on our interactions with FDA, the study may be registration-enabling for a targeted gene and tumor-agnostic label. And we could potentially file for approval in the United States for these indications next year.

The newest Phase III clinical trial for Rubraca is the CASPER study, which is sponsored by the Alliance for Clinical Trials in Oncology, which itself is a part of the National Cancer Institute. CASPER is a Phase III study comparing enzalutamide and Rubraca to enzalutamide and placebo as a novel therapy in all-comer frontline metastatic CRPC. The study, which is expected to begin enrolling in September, will enroll approximately 1,000 patients.

Next, I'll briefly highlight our combination studies with Bristol-Myers Squibb for both Rubraca and lucitanib and then discuss our newest compound, FAP-2286. We remain enthusiastic about our ongoing clinical collaboration with Bristol-Myers Squibb, and I'll take a moment to review certain of our combination studies for both Rubraca and lucitanib with nivolumab. I'll begin with Rubraca.

As I mentioned in our highlights for the quarter, we successfully completed target enrollment in the Clovis-sponsored ATHENA study, our Phase III 1,000-patient study in front-line newly diagnosed advanced ovarian cancer maintenance in June. With ATHENA, we believe we are uniquely positioned to evaluate Rubraca in terms of 2 outcomes. First, as monotherapy versus placebo in the frontline maintenance setting in the HRD population, inclusive of BRCA and in the all-comers or intent-to-treat population as well as any potential advantage of the combination of Rubraca and Opdivo in the same patient populations. ATHENA is the first frontline switch maintenance study designed to show both PARP monotherapy and PARP PD-1 combination therapy in 1 study design.

I'll take a moment to remind everybody of the statistical analysis plan. First, expected in the second half of next year, we will see the results of Rubraca monotherapy versus placebo in all study populations. And then probably a year or more later, we will see the results of Rubraca plus Opdivo versus Rubraca in all study populations. In each of these analyses, we will first evaluate outcomes in the HRD population, including BRCA, and then step down to the entire intent-to-treat population. We believe this study, therefore, offers an opportunity to truly differentiate Rubraca in the frontline maintenance setting.

Beyond ATHENA, FRACTION-GC is a Bristol-Myers Squibb-sponsored multi-arm Phase II study evaluating the combinations of each of Opdivo and Yervoy with Rubraca as well as Opdivo, Yervoy and Rubraca in combination with the treatment of advanced gastric cancer. This is the first sponsored study to explore this triplet combination.

Now I'll turn to lucitanib. Lucitanib, of course, is our investigational inhibitor of tyrosine kinases, including VEGF receptors 1 through 3, PDGF receptors alpha and beta and FGF receptors 1 through 3. In addition to the Rubraca and Opdivo combos being evaluated, our clinical collaboration with Bristol-Myers Squibb includes both ongoing and plan combinations of Opdivo with lucitanib.

The Clovis-sponsored LIO study is a Phase Ib/II study evaluating lucitanib in combination with Opdivo. As we announced earlier this week, the Phase II portion of the LIO-1 study in gynecological cancers is now open for enrollment, and the first patient in the trial has been treated. I'm pleased to say that 2 abstracts related to LIO-1 were accepted as posters for the upcoming ESMO Virtual Meeting next month, including the initial data from the Phase Ib portion of the study as well as a Trial in Progress poster for the Phase II study.

As you may know or may infer from the name, the Trial in Progress poster does not contain study data but describe study design to build awareness for clinicians in support of study enrollment. It has long been our objective to present these initial clinical data at our fall 2020 medical meeting, and I'm grateful to the patients, clinicians and lucitanib team for their continued enthusiasm for this study during this challenging time.

We remain very enthusiastic about our peptide-targeted radiopharmaceutical therapy program, and in particular, our lead program or compound, FAP-2286. FAP is highly expressed in cancer-associated fibroblasts, or CAFs, which are found in the majority of cancer types, potentially making it a suitable target across a wide array of solid tumors. It is highly expressed in many epithelial cancers, including more than 90% of breast, lung, colorectal and pancreatic carcinomas. We believe that recent preclinical data for FAP-2286 in animal models, which will be the subject of a poster at the upcoming ESMO Virtual Meeting is very encouraging, and we look forward to sharing it with you next month.

In addition, we and 3BP, our partner, are collaborating on a discovery program directed at 3 additional targets for radionuclide therapy, to which we have global rights. We regarded to this program for many reasons, including, of course, the opportunity to be a leader in the emerging field of targeted radiotherapy for the treatment of solid tumors. In this case, we have the opportunity to be the first to clinically develop an FAP-targeted radionuclide. And we are also enthusiastic about the targets that are the subject of our ongoing discovery collaboration.

Clovis currently plans to submit 2 INDs applications for FAP-2286 in a relatively close succession during the fourth quarter of 2020 to evaluate FAP-2286 for use as both imaging and treatment agent, respectively. Upon activation of the INDs by the FDA, we intend to initiate a Phase I study to determine the dose and tolerability of the FAP targeting therapeutic agent with expansion cohorts planned in multiple tumor types as part of the global development program. The FAP targeted -- targeting imaging agent will be utilized to identify tumors that contain FAP for treatment in the Phase I study.

This fall, we also expect a leading U.S. academic institution to sponsor and initiate a separate imaging-only study with FAP-2286 to evaluate FAP expression and multiple tumor types. Results from this study, along with other preclinical data we are generating, will help direct our Phase II expansion cohorts to tumors with high FAP expression. And with that, I'll turn the call over to Dan to discuss second quarter financial results.

--------------------------------------------------------------------------------

Daniel W. Muehl, Clovis Oncology, Inc. - Executive VP & CFO [4]

--------------------------------------------------------------------------------

Thanks, Pat, and hello, everyone. We reported net product revenue for Rubraca of $39.9 million for Q2 2020, which included U.S. net product revenue of $36.7 million and ex-U. S. net product revenue of $3.2 million. This includes a modest amount of net revenue from our new prostate indication in the U.S. for the 6 weeks following the May 15 approval.

Second quarter 2020 net revenue represents a 21% increase over Q2 2019, in which we reported net revenue of $33 million including net product revenues in the U.S. of $32.7 million and ex U.S. of $0.3 million. The second quarter of 2019 represented the first quarter of Rubraca sales outside of the U.S.

For the first half of 2020, we reported net product revenue for Rubraca of $82.5 million compared to $66.1 million in the first half of 2019, an increase of 25%. Net product revenue decreased 6% sequentially from Q1 to Q2 2020, and we attribute this to the effects of COVID-19 during the quarter, principally due to reduced paid U.S. new patient starts as a result of fewer diagnoses and office visits.

The effects of COVID-19 on our business and operating results are difficult to assess or predict, in particular, given the increase in cases in major markets in the U.S. We may continue to see an impact on revenues related to COVID-19 for the remainder of 2020. Gross to net adjustments totaled 19.4% in Q2 2020 compared to 22.6% in Q1 2020.

The sequential decrease in gross to net adjustments reflects primarily a decrease in activity in the U.S. contracting and government-related programs. We expect gross to net adjustments to remain in the low 20% range, depending on revenue and distribution mix for the U.S. and Europe. The decrease in gross to net adjustments was mostly offset by an increase in our free goods percentage, which increased from 12.4% in Q1 to 16.2% in Q2 or $7.1 million in commercial value.

Distributor inventory was only slightly higher at the end of Q2 versus Q1, indicating minimal change in distributor inventory as a reaction to COVID-19. We currently have no issues with either drug supply or distribution of drug to the patient. We have described product supply cost as a meaningful part of our cash spend over the last couple of years as we transition to a new manufacturing facility and have significant supply available.

Turning now to a discussion of cash. As of June 30, we had $261.4 million in cash and equivalents. This includes the $82.8 million in net proceeds raised in an equity offering of 11.1 million shares of common stock in May 2020. Through the end of the second quarter, we have reduced our total outstanding convertible debt by $145.1 million and outstanding principal amount.

And as of June 30, we had drawn approximately $68 million under the TPG ATHENA clinical trial financing and had up to $107 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

Based on the company's anticipated revenues, spending, available sources -- financing sources and existing cash and cash equivalents, we believe we have sufficient cash and cash equivalents to fund our operations into early 2022, including any cash repayment, unless refinanced earlier, of the remaining $64.4 million, an aggregate principal amount of the 2.5% convertible notes at their maturity in September 2021.

Net cash used in operating activities was significantly lower at $59.9 million for Q2 2020 compared to $98 million for Q2 2019. Similarly, net cash used in operating activities for the first half of 2020 was $142.4 million compared with $196.5 million for the same period in 2019.

Borrowings under the TPG ATHENA financing provided $17.7 million in cash in Q2 2020, and we paid a milestone payment to Pfizer of $8 million for the U.S. mCRPC approval. Cash burn in Q2 2020 was $50.1 million, a 25% decline from the Q1 2020 cash burn of $66.9 million.

We continue to manage cash carefully to extend our runway into 2022. And we expect cash burn to decrease in the second half of 2020 compared to the first half of 2020 and for the full year 2021 compared to 2020.

We reported a net loss of Q2 -- for Q2 2020 of $92.2 million or $1.15 per share compared to a net loss for the second quarter of 2019 of $120.4 million or $2.27 per share. We reported a net loss for the first half of 2020 of $191.6 million or $2.52 per share compared to a net loss of $206.9 million or $3.91 per share in the comparable period in 2019. Net loss for the second quarter and the first half of 2020 included share-based compensation of $13.3 million and $26.3 million compared to $14.1 million and $27.8 million for the same periods in 2019.

Research and development expense totaled $69.9 million for Q2 2020 compared to $70.7 million for the second quarter of 2019. R&D in the first half of 2020 totaled $138.1 million compared to $132.8 million in the first half of 2019. We expect research and development expenses to be lower than the full year 2021 compared to 2020.

Selling, general and administrative expenses totaled $41.9 million for Q2 2020 compared to $48 million for Q2 2019.

SG&A for the first half of 2020 was $84.85 million -- $84.5 million compared to $95.8 million for the first half of 2019. Selling, general and administrative expenses decreased during the second quarter and the first half of 2020, partly resulting from savings due to the COVID-19 situation globally and overall cost reduction efforts.

We continue to expect savings in selling, general and administrative expenses as a result of the COVID-19 situation globally.

As noted, we expect our R&D expenses to decrease in 2021 compared to 2020, SG&A expenses should continue approximately at this lower Q2 2020 level during the upcoming quarters through 2021. These factors, along with planned revenue, should contribute to a reduction in quarterly cash burn into and through 2021.

I'll turn the call back over to Pat.

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [5]

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Thanks, Dan. In summary, we made progress in a difficult quarter despite the near-term headwinds that COVID-19 presents. We believe that Rubraca offers significant advantages as a maintenance therapy of choice for recurrent ovarian cancer patients and as a new therapeutic option for BRCA-mutant recurrent metastatic castrate-resistant patients in the evolving chronic COVID-19 environment as physicians continue to seek to reduce patient visits for clinics. As access remains challenging, we will continue to adapt our efforts to engage with clinicians during this period, which, of course, may be extended as resurgences of the virus continue in the U.S. and Europe.

I'm very pleased that we've completed target enrollment in the ATHENA study, which is the first frontline switch maintenance study designed to evaluate PARP monotherapy and PARP PD-1 combination therapy in 1 study design, for which we anticipate initial monotherapy data in the second half of 2021.

Organization is looking forward to next month's ESMO Virtual Congress, at which data for all 3 of our commercial or development stage products will be presented.

We also remain focused on continuing to manage our net cash utilized in operations. As an example of this commitment, even with a modest decline in sales compared to Q1, we reduced our cash burn by 25% in Q2 compared to Q1. And as Dan described, we believe we have sufficient resources today to fund our operations in the early 2022.

With that, I'll be happy to answer any questions you may have.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Our first question comes from the line of Kennen MacKay of RBC Capital Markets.

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Kennen B. MacKay, RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research [2]

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Maybe sort of 2 commercial questions. In ovarian, wondering if from your perspective, you do think things are beginning to come back to normal now that sort of a national lockdown has been eased, even if it is a little bit of sort of a voluntary rolling lockdown in various geographies across the country. And then second, in prostate, first off, congrats on the NCCN Category 2A listing, wondering if you can help us understand the current prescribing and reimbursement dynamic. What diagnostic is currently being used to prescribe Rubraca?

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [3]

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Yes. So returning to normal in ovarian. Kennen, I'd say it's -- adaptations are being made in a new normal. Patient visits and diagnoses were down considerably in Q2 compared to Q1. But we do see evidence that -- and it's regional, that it is getting better. But I wouldn't say it's -- we are not, in our opinion, at sort of December-January levels yet. And the clinics are managing the patients far differently than they did before. Things you may have done in other or seen in other therapeutic areas. Patients waiting in their cars, getting a text to come in, doing their best to get them out of the clinic as fast as they can. So I wouldn't call it returning to normal. And definitely, normal would require a high amount of sales rep access. And while territory by territory, region by region, we do see some clinics open to this type of participation, I'm actually going to one of our sales leader's territories next week, and I will be making some office visits. So there will be some regions, territories where office visits are occurring. But as you read in the paper every day, there are parts of this country that are really struggling. And in most of those locations, there has not been a return to normal, and there's not a good amount of access.

With regard to prostate, reimbursement is no problem, but it's early days and only so many patients so far, but we have not had and do not anticipate an issue with reimbursement. There are germline tests, commercially available that can be used -- that are blood test, but that would only capture about 0.5% of our target population. To remind you, about half of our BRCA prostate cancer patients have a germline mutation, about half have a somatic mutation. And there are sort of CLIA lab like tests available, including from Foundation and including from a company called Guardant, also a very good company, but we can't promote to them. And so it's not the easiest dialogue they have. It has to be physicians who have experience with either of those organizations. The med onc community who is treating prostate is more likely to have done so. The urology community will not have had any experience with either Guardant or Foundation. So there -- it's a little tough with urologists right now.

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Kennen B. MacKay, RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research [4]

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Got it. And maybe just to expand on that, can you just remind us, in your current metastatic indication -- post chemo metastatic indications, what percent of targeted prescribers are urologists versus medical oncologist?

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Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [5]

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It's probably around 20% are urologists and about 80% are med onc. It could be more like 25%, urologist. But right now we would say around 20% urologists.

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Edited Transcript of CLVS.OQ earnings conference call or presentation 6-Aug-20 8:30pm GMT - Yahoo Finance

Researchers Using Models To Understand COVID-19, Other News – Bio-IT World

August 7, 2020 |Researchers are continuing to analyze COVID-19 through several models. A new mouse model is being developed in China to test and confirm the efficacy of a potential vaccine, while a researcher in the US is using computer models to understand the structure of the virus.

Literature Updates

Researchers in China have developed anew mouse modelof COVID-19 infection that may help facilitate testing of vaccines and therapeutics. The model, which has been used to test and confirm the protective efficacy of a COVID-19 vaccine candidate, is described in a recent article published in Science. Efforts to study virus infection and evaluate vaccines in mice have up to now required mice to be engineered to express human ACE2. This represents a new approach where a strain of SARS-CoV-2 seen in the clinic is adapted in the mouse respiratory tractto develop a mutant version that was able to replicate and cause disease in young and aged mice; both groups showed pneumonia and inflammatory responses after intranasal infection, clinical features seen in human patients. DOI: 10.1126/science.abc4730

In an article in Research Ideas and Outcomes, a researcher at The Catholic University of America(Washington, D.C.) details how he has used computer models to understand the structure of the SARS-CoV-2 virus on the molecular level and try to figure out how the virus functions. It describes how antibodies found in the first SARS outbreak in 2002 (80R and m396) were reengineered to fit the new virus using computer simulation, and points to the discovery that sequence differences prevent 80R and m396 from binding to COVID-19which could pave the way to engineering new antibodies that are effective. Docking experiments utilizing supercomputers at the Texas Advanced Computing Centerand Pittsburgh Supercomputer Centershowed that amino acid substitutions in 80R and m396 should increase binding interactions between the antibodies and SARS-CoV-2. The in-silico analysis could fast-track passive immunity that could prevent infection for several months. DOI: 10.3897/rio.6.e55281

Researchers at the Institute of Organic Chemistry and Biochemistry of the Czech Academy of Scienceshave used X-ray crystallography to determine and analyze the precise structure of the complex of the Nsp16 and Nsp10 coronavirus proteins. They report in Nature Communications that theyve identified a deep canyon on the surface of the protein complex where binding of the viral RNA occurs, and a cap is installed. A cap is a special structure of SARS-CoV-2 that allows the virus to infect the human body and multiply within it. Targeting the canyon by inhibitors that suppress the activity of the Nsp16 and Nsp10 protein complex may, in the future, serve as drugs to combat many coronaviruses. DOI: 10.1038/s41467-020-17495-9

Researchers from the Perelman School of Medicine at the University of Pennsylvaniahave identified a protein called histone deacetylase 3 (HDAC3) as the orchestrator of the immune system's inflammation response to infection. This has implications for COVID-19 as well as other diseases such as cancer, heart disease and diabetes where the rise-and-fall in inflammatory factors go unchecked. Using both specially cultured cells and small animal models, HDAC3 was found to be directly involved in the production of agents that help kill off harmful pathogens as well as the restoration of homeostasis. Their work, published in Nature, shows that some of the methods being tested to fight harmful inflammation that target molecules like HDAC3 could have unintended and deadly consequences. The non-enzymatic functions of HDAC3, which have been previously under-appreciated, are responsible for the production of cytokine storma highly lethal phenomenon widely reported in patients infected with COVID-19. DOI: 10.1038/s41586-020-2576-2

Virologists in the College of Veterinary Medicine at Kansas State Universityhave published a study in Science Translational Medicineshowing a possible therapeutic treatment for COVID-19. It reveals how small molecule protease inhibitors show potency against human coronaviruses, including SARS-CoV-2 and Middle East respiratory syndrome coronavirus (MERS-CoV). These coronavirus 3C-like proteases (aka 3CLpro) are strong therapeutic targets, they say, because they play vital roles in coronavirus replication. In their study, optimized coronavirus 3CLpro inhibitors blocked replication of the human coronaviruses MERS-CoV and SARS-CoV-2 in cultured cells and in a mouse model for MERS. Co-collaborators on the research are at Wichita State University, the University of Iowa and the University of Kansas. DOI: 10.1126/scitranslmed.abc5332

Brazilian researchers have shown that artificial intelligence can increase the effectiveness of drug repositioning or repurposing research for psychiatric and neurological disorders, and the novel drug screening approachwill now be used in another study with the aim of repurposing drugs to treat COVID-19. In a study published back in May in Translational Psychiatry, they correlated information on genes associated with these disorders and drugs approved for use in treating other diseases that might potentially inhibit or activate these genes. That study identified 63 drugs targeting 31 genes and potential candidates for testing against Alzheimer's disease, Parkinson's disease, Huntington's disease, depression, anxiety, bipolar disorder, schizophrenia and autism. A total of 1,588 genes were correlated with 722 drugs. They used a machine learning approach known as network medicinean emerging field that combines systems biology and network science to understand how genes interact in disease and healthto investigate the molecular characteristics and mechanisms of the psychiatric and neurological disorders. The group used IBM Watson for Drug Discoveryas well as programs developed in their own laboratory to mine information in more than 20 million scientific articles published over the last 50 years. DOI: 10.1038/s41398-020-0827-5

One of the immune system's oldest branches, called complement, may be influencing the severity of COVID disease, according to researchers at Columbia UniversityIrving Medical Center. Among other findings linking complement to COVID, the researchers found that people with age-related macular degenerationa disorder caused by overactive complementare at greater risk of developing severe complicationsand dying from COVID. The connection with complement suggests that existing drugs that inhibit the complement system could help treat patients with severe disease. The study published in Nature Medicine. The authors also found evidence that clotting activity is linked to COVID severity and that mutations in certain complement and coagulation genes are associated with hospitalization of COVID patients. Findings stem from an earlier finding that coronaviruses are masters of viral mimicry, particularly with proteins involved in coagulation and proteins that make up complement. DOI: 10.1038/s41591-020-1021-2

SARS-CoV-2presents at least six strainsand, despite its mutations, shows little variability (approximately seven mutations per sample, less than half that of common influenza)good news for the researchers working on a viable vaccine, which was shared by scientists at the University of Bologna (Italy) in Frontiers in Microbiology. Results drew from an analysis of 48,635 coronavirus genomes that were isolated by researchers in labs across the world. They then mapped the spread and mutations of the virus during its journey to all continents. Treatments under development, including a vaccine, might be effective against all the virus strains, the authors conclude. DOI: /10.3389/fmicb.2020.01800

Researchers affiliated with the Optics and Photonics Research Center(Brazil) advocate for photodynamic therapy to combat secondary infections in COVID-19 patientsin an article published in Photodiagnosis and Photodynamic Therapy. The technique combines light and a photosensitizing chemical substance to kill microorganisms in the respiratory tract. The compounds interact with light to produce a highly reactive oxygen species that kills viruses and bacteria by oxidizing their membranes. When the patient inhales these substances, the drug can be activated with extracorporeal light, which then attacks pathogens in the airways. Photodynamic therapy cannot be used to attack SARS-CoV-2 directly but it can be used as a treatment for COVID-19 coinfections caused by bacteria and other viruses, they argue. Several studies have already been conducted on the use of photodynamic therapy to treat pneumonia, skin cancer, and other diseases, and a new study is about to begin in partnership with researchers at the University of Torontoin Canada that will evaluate its use in cases of pneumonia in pigs. DOI: 10.1016/j.pdpdt.2020.101804

Luring SARS-CoV-2 with a decoyan engineered, fee-floating receptor proteinbinds the virus and blocks infection, suggests a study published in Science. Administering a decoy based on ACE2, the receptor protein on the surface of the cell to which the coronavirus binds, might neutralize infection as well as rescue lost ACE2 activity and directly treat aspects of COVID-19, the researchers say. As a potential therapeutic agent, a decoy receptor would have an advantage over other drugs because to evade it the virus would have to mutate in a way that makes it less infectious. The decoy, unlike ACE2, would be optimized for the binding role. After examining more than 2,000 ACE2 mutations and creating cells with the mutant receptors on their surfaces, researchers found a combination of three mutations that created a receptor that bound to the virus 50 times more strongly. They then made a soluble version of the engineered receptor. The strong affinity between the virus and the decoy receptorrivaling the best antibodies identified to datehas been verified by the U.S. Army Medical Research Institute of Infectious Diseasesas well as at the University of Illinois. The decoy receptor is now being tested in mice and exploring how it bonds to other coronaviruses with potential to become future pandemics if they cross from bats to humans. DOI: 10.1126/science.abc0870

In another study published in Science, scientists show that memory helper T cells that recognize common cold coronaviruses also recognize matching sites on SARS-CoV-2. That may explain why some people have milder COVID-19 cases than others, they speculate. Immune reactivity may translate to different degrees of protection, with those having a strong T cell response afforded the opportunity to mount a much quicker and better response. The work builds on previous reports from around the globe that many people never exposed to SARS-CoV-2 had T cells that reacted to the virus. For this study, researchers found that unexposed individuals can produce a range of memory T cells that are equally reactive against SARS-CoV-2 and four types of common cold coronaviruses. They additionally found that pre-existing immune memory was directed not only at the SARS-CoV-2's spike protein, which most vaccine candidates are targeting, but also other SARS-CoV-2 proteins. It might therefore be possible to take advantage of this cross-reactivity with multiple viral targets to further enhance vaccine potency. DOI: 10.1126/science.abd3871

Researchers at Yale University School of Medicine have developed a new mouse modelto study SARS-CoV-2 infection and disease, aiding in the discovery that key antiviral signaling proteinsmay not protect the lungs but rather cause much of the tissue damage associated with COVID-19. To create their alternative mouse model, the animals were first infected with a different, harmless virus carrying the human ACE2 gene that enabled the SARS-CoV-2 to replicate and induced an inflammatory response like that observed in COVID-19 patients. The infected mice also rapidly developed neutralizing antibodies against SARS-CoV-2. When the mice lacking the key components of the type I interferon pathway were infected, they were no worse at controlling SARS-CoV-2 infection, but they also recruited fewer inflammatory immune cells into their lungs. This indicates that type I interferonscurrently being used as a treatment for COVID-19dont restrict SARS-CoV-2 replication and may play a pathological role in COVID-19 respiratory inflammation. The early timing of interferon-based treatment will be important for it to provide protection and benefit, they say. Results published in the Journal of Experimental Medicine. DOI: 10.1084/jem.20201241

Genes thought to play a role in how the SARS-CoV-2 virus infects human cells are active in embryos as early as the second week of pregnancy, say scientists at the University of Cambridgeand the California Institute of Technology. The researchers say this could mean embryos are susceptible to COVID-19 if the mother gets sick, potentially affecting the chances of a successful pregnancy. To examine the risks, they cultured human embryos through the stage they normally implant in the body of the mother to look at the expression of key genes. Findings included patterns of expression of ACE2 (providing the genetic code for the SARS-CoV-2 receptor) and TMPRSS2 (providing the code for a molecule that cleaves both the viral spike protein and the ACE2 receptor), allowing infection to occur. These genes were expressed during key stages of the embryo's development, and in parts of the embryo that go on to develop into tissues that interact with the maternal blood supply for nutrient exchange. The study, published in Open Biology, reports the finding of the RNA messengers. Researchers emphasize the importance of women planning for a family to try to reduce their risk of infection. DOI: 10.1098/rsob.200162

Initial data from mice suggest thatSARS-CoV-2 might not be targeting taste buds, as has been suspected due to reports of some COVID-19 patients losing their sense of smell and/or taste. University of Georgia researchers report in ACS Pharmacology & Translational Sciencethat they found ACE2 (a receptor on the surface of some cells, including those of the human tongue) was enriched in cells that give the tongue its rough surface, but couldn't be found in most taste bud cells. That means the virus probably doesnt cause taste loss through direct infection of these cells. Instead, taste buds might be damaged by inflammation caused by the infection. They also showed that other viruses that affect taste, including the flu virus, might affect different tongue cell types. Based on an analysis of mice at different developmental stages and previous studies in humans, it also appears possible that fetuses have distinct susceptibilities to SARS-CoV-2 infection at different stages. DOI: 10.1021/acsptsci.0c00062

The latest paper about the Moderna-NIH vaccine mRNA-1273 that recently entered phase 3 human trials published in Nature, describing both preclinical resultsand the carefully engineered spike protein that mimics the infection-spreading part of the SARS-CoV-2 virus. The investigational vaccine induced neutralizing antibodies in mice when given as two intramuscular injections of a 1-microgram (mcg) dose three weeks apart; mice given two injections of the 1-mcg dose and later challenged with SARS-CoV-2 virus either five or 13 weeks after the second injection were protected from viral replication in the lungs and nose. Importantly, mice challenged seven weeks after only a single dose of 1 mcg or 10 mcg of mRNA-1273 were protected against viral replication in the lung. The investigational vaccine also induced robust CD8 T-cell responses. Years of earlier research into coronaviruses was critical for the fastest-ever progression (66 days) from virus genome sequencing to vaccine testing in humans. The spike protein is a shapeshifter, changing its structure before and after fusing with cells. The immune system responds best when the spike protein is in its prefusion shape, so researchers reengineered the protein in two key places to lock it into that shape. Using small genetic modifications to the gene sequence that encodes for the protein, they essentially made part of the spring-loaded portion of the molecule more rigidthe same tactic successfully used back in 2017 to stabilize the shape-shifting spike protein for MERS-CoV. The protein engineering work was led by a team at The University of Texasat Austin. Other collaborating institutions on the preclinical work were the University of North Carolina at Chapel Hill and Vanderbilt University Medical Centerin Nashville. DOI: /10.1038/s41586-020-2622-0

A team of chemists from HSE University and the Zelinsky Institute of Organic Chemistry(Russia) used molecular modelling to find out that two well-known medicationsdisulfiram (for alcoholism) and neratinib (experimental drug for breast cancer)can be used to fight SARS-CoV-2, as reported in Mendeleev Communications. The classical docking process used for molecular modeling doesnt work in SARS-CoV-2, so they instead used an on-top docking method that they invented shortly before the pandemic. It involved investigating the entire surface of the Mpro target protein with many medications and hoping big calculation powers would return useful dockings. The potential drugs were taken from a database of FDA-approved medications and the research team's own algorithms were used for modelling. In tests performed at Reaction Biology Corp., a certified laboratory in the U.S., both disulfiram and neratinib were found to inhibit Mpro, although the latter was deemed insufficient for clinical use. The main achievement is demonstration of the new on-top docking approach in returning realistic and controllable results. DOI: 10.1016/j.mencom.2020.07.004

In Molecular Systems Biology, researchers at Uppsala University(Sweden) have described the presence of angiotensin I converting enzyme 2 (ACE2)thought to be the key protein used by the SARS-CoV-2 virus for host cell entry and development of COVID-19throughout the human body. In contrast to previous studies, theirs shows that no or very little ACE2 protein is present in the normal respiratory system. The article presents a large-scale, systematic evaluation of ACE2 expression in more than 150 cell types, at both messenger RNA (mRNA) and protein levels. The fact that ACE2 has limited expression in respiratory epithelial cells highlights the need for further study of the biological mechanisms responsible for COVID-19 infection and disease progression, they say. The expression profiles in previous studies indicating that ACE2 is highly expressed in the human lung have not been reliably presented along with tissues and organs from the entire human body or based on several different datasets at mRNA and protein levels. For this study, immunohistochemical analysis of 360 normal lung samples from an extended patient cohort was based on the Human Protein Atlas resource. Two different antibodies, which were stringently validated, were used. DOI: 10.15252/msb.20209610

Industry Updates

Oxford Nanoporelaunched its novel LamPORE SARS-CoV-2 test and announced an agreement with the UKs Department of Health and Social Care, to make an initial 450,000 LamPORE tests available for use by a number of NHS testing laboratories. As well as providing a large number of tests for existing labs, the program will help the UK to understand the different use cases for the technology, for example the potential asymptomatic screening of frontline staff. Because of its scalability, LamPORE has the potential to provide both large-scale screening to detect the virus in broader populations, and rapid, focused, localized analysis. LamPORE is designed to be deployed on Oxford Nanopores desktop device (GridION) or palm-sized device (MinION Mk1C), providing the capacity of processing up to 15,000 saliva or swab RNA samples a day or 2,000 samples a day respectively. It is well suited to use in a central laboratory for high-throughput sample processing, or near-community pop-up lab. LamPORE results can be generated in under two hours. Oxford Nanopore is currently also developing LamPORE to test for multiple pathogens within a single sample, including influenza A (H1N1 and H3N2), influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2. This is intended to allow healthcare professionals to distinguish between these infections, better manage expected winter pressures on the NHS and guide public health and clinical management of these diseases at a time of traditionally heightened pressure on health services. Press release.

The AI-powered nonprofit startup Reboot Rx has launched the Reboot: COVID-Cancer Project, a free, publicly accessible resource for researchers and physicians to quickly find and review data on COVID-19 and cancer. Cancer patients are among those with the highest risk of dying from COVID-19. From over 170,000 published studies and registered clinical trials, Reboot Rx has identified the 850 that are most relevant for cancer patients with COVID-19. The Reboot: COVID-Cancer Project provides crucial insights into treatment responses and mortality rates to understand how cancer patients are uniquely vulnerable to COVID-19. Through this effort, Reboot Rx is helping researchers and physicians pursue the most effective treatments. Press release.

Thermo Fisher Scientific has launched a new, highly automated, real-time PCR solution designed to analyze up to 6,000 samples in a single day to meet increasing global demand for COVID-19 testing. The Thermo Fisher Scientific Amplitude Solution is a molecular diagnostic testing system that leverages the company's Applied Biosystems QuantStudio 7 Flex Real-time PCR instruments along with liquid handling products from Tecan Group, a global leader in laboratory automation and liquid handling. The modular solution delivers test results in a four-step process requiring minimal hands-on time, laboratory space and staffing resources. The Amplitude Solution utilizes Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, a fast, highly sensitive multiplex diagnostic test that contains the assays and controls needed for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19. The company will submit this new end-to-end solution to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA) and plans to secure additional authorizations globally. Press release.

P33, Open Commons Consortium(OCC) and MATTER have launched the Chicagoland COVID-19 Data Commons(CCC), a centralized data platform created in partnership with regional healthcare providers, to help clinicians, researchers and community advocates understand how the disease behaves within the Chicagoland population. P33, a private-sector led initiative promoting inclusive tech growth in Chicagoland; the OCC, a builder of data commons and data-sharing ecosystems; and MATTER, healthcare startup incubator, partnered to create the Chicagoland COVID-19 Data Commons to understand the pandemic, measure Chicagoland's regional response and build a helpful decision-making tool for local government. COVID-19 has already had a devastating impact on our communities. In Chicago, there have been almost 60,000+ cases of COVID-19 identified residents and almost 140,000+ in Illinois. The impact has been particularly hard on black and Latinx communities. The OCC, MATTER and P33 are engaging hospitals and nonprofits in Chicagoland that are serving patients impacted by the disparities of COVID to include their clinical data in the CCC, ensuring accurate representation of the data across all zip codes in Chicago. Participating health systems and hospitals include Rush University Hospital, University of Chicago, University of Illinois Chicago, St Anthony Hospital, Sinai Health System, Medical Home Network, NorthShore University Health Systems, Community Health, and Illinois Association of Free and Charitable Clinics. Press release.

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Researchers Using Models To Understand COVID-19, Other News - Bio-IT World

Dr Mukesh Batra: The alternative medicine man – Livemint

After a 3-hour Zoom interview with Dr Batra, the comparison seems to hold good on many counts. He is easily the best-known, most commercially successful homoeopath from India. His network, spanning six countries, is managed by a team of 400 doctors across 225 clinics. In FY18, his company reported 225 crore in revenue. Like the actor, Dr Batras full head of hair defies his age69. But it would be strange if it didnt. After all, his company built a fortune mainly on the back of hair- and skin-care treatments.

In person, Dr Batra is all wit and charm. Think of (our business) as papad," he says. Lots of housewives made papad in India. Then Lijjat came and institutionalized it." Thats what he did with homoeopathy in India, he says: We formalized and corporatized it."

The chat took place over two sittings, with an hours break at lunchtime. Considerable time was spent discussing the efficacy of his treatments. For, homoeopathy hasnt found acceptance amongst the scientific community. Some go so far as to describe it as hokum, offering hope when there isnt any. Over the past decade, regulatory bodies in several countries have declared their reservations. France has announced it will stop reimbursing citizens for homoeopathic treatment expenses from 2021, theres a growing demand in the UK to follow suit. In 2015, a landmark Australian study analysing over 1,800 papers on homoeopathy concluded there was no good quality evidence to support the claim that homoeopathy is effective in treating health conditions".

Dr Batra, however, has a ready retort. A lot of these studies are biased and we shouldnt get carried away by them," he says. Homoeopathy does have its limitations, he accepts: There isnt much it can do for a gunshot wound, for example. But in many chronic psychosomatic cases, it plays a very good role."

But then, he adds, hes used to sceptics. Back in the 1980s, when I would go to a party and say I am a doctor, people would say, Oh very good. When I would tell them I am a homoeopath, they would do a namaste and then say their bye-byes and thank yous."

In recent years though, homoeopathy has found greater public acceptance and political backing in India. And after the covid-19 outbreak in January, the Union ministry of Ayush (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) recommended Arsenicum Album 30 as an immunity booster". In the following weeks, Dr Batras network, like numerous politicians, businessmen and members of civil society, distributed the pills in large numbers. There are no clinical trials proving its efficacy against covid-19, Dr Batra agrees. But if a proper trial is done, he adds, you can give the world scientific evidence on the basis of which homoeopathy works for various diseases".

In a normal world, it would have been possible to meet Dr Batra at his clinic off Chowpatty in Mumbai. Its a small office behind Wilson College, where he set up his first clinic with the first electronic medical software in the world". But concessions have to be made for the pandemic.

So, one afternoon, my laptop lit up to the living room of a 150-year-old Portuguese mansion in Aldona, Goa. Dr Batra was sitting on a wooden chair, wearing a cool blue polo-neck. A vintage dining set formed the backdrop, a chandelier suspended above it.

His family had flown to Goa in March for a break from the city, Dr Batra says, agreeing that its not a bad place to be stuck in. Plus, we have a mango tree, so we get the best local mangoes. They are not Alphonsos but they are fabulous."

Dr Batra retired from active practice five years ago. His son Akshay, also a homoeopath, runs the day-to-day operations now. Dr Batra continues to be the face of the brand but more as the chairman emeritus". Meaning, I give advice when asked. If not asked, I keep my mouth shut." Lately, he has been spending time in charity work, photography and on penning his biography.

The story begins in Lucknow. Dr Batras parents were doctors. His father, a homoeopath, was the principal at a local college and mother, an allopath, worked as the deputy health secretary with the Uttar Pradesh government. My parents were busy people," he says. I experienced how medicine was all-consuming and decided that I wont become a doctor at all."

In the late 1950s, Dr Batras father landed a job as the principal of the Bombay Homoeopathy College in Vile Parle, now known as Smt Chandaben Mohanbhai Patel Homoeopathic Medical College. He was just 7 when they moved to Mumbai. After he finished high school, a trustee from his fathers college offered him a seat at the institution. He told me homoeopathy was growing, it will be good for you.... I thought, some people mortgage their land and jewellery with the ambition that their child would become a doctor. Here, I was getting an invitation." Was there no entrance exam? It was a relatively new college, says Dr Batra. They wanted people from good homes."

He didnt start off as a serious" student. But he soon had a change of heart. During my college days, I had developed 28 warts on my face. I had the annual day coming up and was supposed to go up on stage for an address." At his fathers suggestion, he used homoeopathic medicines.Within two days, he says, the warts fell off. There were no scars. It was magical."

After a bachelors degree in homoeopathy, he got another in psychology from Pune University. His first job was at a charitable hospital in Malabar Hill, at age 23. Within a few years, he had gained a reputation as a hard-working, enterprising doctor. In 1982, he set up his first clinic, at Chowpatty.

The next decade was a blur. Between consulting patients, paying off loans and raising two children with his now ex-wife Nalini, he was heading for a burn-out. In 1996, he decided to turn his general practice into a super-speciality. He hired a market research agency, surveyed his patients and identified 14 segments where his treatments had shown good results. Once he stopped general consultation, his patient load fell from 150 to two a day. He had more time to research and spend on each diagnosis. Two years on, he rebranded Positive Health Clinic" to Dr Batras Positive Health Clinic".

It was around this time that Dr Batras association with hair loss and skincare treatment began. He hadnt planned on it, he says. The Drugs and Cosmetics Act has a list of diseases one cant advertise for. Hair and skin are an open category. So we started advertising." Later, Akshay, who also became president of the The Trichological Society, UK, drove a targeted outreach for Dr Batras hair-related treatments. Today, says Dr Batra, over 45% of their 80,000 patients are seeking treatment for hair loss.

In business, he says, he followed the Raj Kapoor model: If his movie did well, put the money in a new one." Soon, he set up a second clinic in Bengaluru. Once successful, he set up more, hiring and training a fleet of doctors, expanding to more cities and later, countries. It has only been onward and upwards since.

For all his success, Dr Batra hasnt escaped bad press. Quora and Reddit threads are littered with criticism of him, trashing the 96.6% treatment success rate" he advertises. One of the most commented threads reads, How big a scam is Dr Batras?"

It pains me a lot to see it happening," he says. But its usually the unhappy customers talking about it, not the happy ones."

Between 2013-18, the Advertising Standards Council of India, an independent watchdog, pulled up Dr Batras several times for misleading advertisements and exaggerated claims. In 2014, it was for claiming to have won an award for being Indias only trusted brand in homoeopathy". In 2017, it was for advertising cures for diseases in violation of the Drugs and Cosmetics Act and Drugs and Magic Remedies (Objectionable Advertisements) Act. In 2018, for advertising a certain gene-targeted therapy that could predict and prevent diseases 15-20 years before they show up".

Dr Batra is convinced it boils down to competition, jealousies". Beyond a point, you cant argue. Its a quasi (judicial) body, not legal. So should I waste my time in controversies or get on with my life?" Dr Batras, he adds, is governed by the food and drugs administration (FDA) and the Central Council of Homoeopathy. We have had no complaints so far."

Asked about the resistance to homoeopathy in the West, he says: The (British) royal family uses homoeopathy. I can send a list of important people in the world who do too."

Popular isnt necessarily effective, is it?

The way homoeopathy medicine is administered in the West differs from India, says Dr Batra. There are more than 300 double-blinded randomized control trials (RCTs) done on asthma, arthritis, etc," he adds. While Mint couldnt independently confirm this claim, several reviews of RCTs in homoeopathy have questioned the procedural rigour and quality of evidence. Dr Batra does agree that for homoeopathy to be established as a scientific system, many more trials are needed.

Today, people are looking at holistic healing. The side effects of allopathy are making a move.... And we have government support too, which we didnt have for so many years. As these things keep evolving, you will see the benefit more and more. And just like we took yoga to the world, we will take homoeopathy too."

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Dr Mukesh Batra: The alternative medicine man - Livemint

Pompe Disease Treatment Market Supply Demand Report, Top Companies, Research Forecast, Analysis and (Volume and Value) and Growth to 2025 Shared in…

Global Pompe Disease Treatment Market report comprehensively analyzes the Global Pompe Disease Treatment market status, supply, sales, and production. The Pompe Disease Treatment market shares of production and sales are evaluated along with the review of the production, capacity, sales, and revenue. Various aspects such as Pompe Disease Treatment import or export, price, gross margin, consumption, and cost are also analyzed. On the whole, the report covers the Pompe Disease Treatment market view and its growth probability for upcoming years.

Get a sample copy of the report https://www.marketreportsworld.com/enquiry/request-sample/14139380

Pompe Disease Treatment Market report briefs all challenges and opportunities in the Pompe Disease Treatment market. The study discusses Pompe Disease Treatment market key events, new innovations, and top players strategies. The user gets wide knowledge and deep perceptive of Pompe Disease Treatment restraints, distinct drivers, and factors impacting the industry. So that they can plan their growth map of the Pompe Disease Treatment industry for the coming years.

Pompe Disease Treatment Market Research Report Global Forecast till 2025

Global Pompe Disease Treatment Market: Information by Type (Late-Onset Pompe Disease, Classic Infantile-Onset Pompe Disease, Non-Classic Infantile-Onset Pompe Disease), by Therapy (Enzyme Replacement Therapy (ERT) and Gene Therapy), End User (Hospitals & Clinics and Research & Academic Institutes) and Region (Americas, Europe, Asia-Pacific and the Middle East & Africa) Forecast till 2025

Market analysis

Pompe disease is a genetic metabolic disorder that is usually seen in infants. This disease is caused due to the mutations in the GAA gene which produces the acid, alpha-glucosidase enzyme, that translates glycogen into a simple form. The absence or mutation in the GAA gene results in the accumulation of glycogen that creates heart problems, muscle weakness, and liver harm that can lead to early death in newborns. Factors such as limited awareness about treatment methods and the high cost of therapy hinder market growth. The key factors that drive the Pompe disease treatment market are increasing government initiatives and increasing R&D by manufacturers. The Global Pompe Disease Treatment Market is likely to register a CAGR of 2.6% to attain USD 1,414.1 Million by the year 2025. The Orphan Products Grants funded 18 new grants from a total of 92 grant applications in 2015, to support around 67 ongoing clinical studies that are related to rare diseases as the government has been taking continuous initiatives for the progress and manufacture of advanced products for the diagnosis and treatment of rare diseases such as Pompe disease. Additionally, the governments of various countries such as Sweden, India, the Netherlands, and South Korea are focusing on approving guidelines for the reimbursement of patients enduring enzyme replacement therapy (ERT) for the treatment of Pompe disease. The State Government of Karnataka along with the Employee State Insurance Corporation provides free of cost ERT to patients with lysosomal storage disorders. Additionally, the Union Ministry of Health and Family Welfare has been taking active initiatives for producing a fund of an amount of 13,940 USD million for the treatment of rare diseases, including lysosomal storage disorders. These growing government initiatives for promoting and advancing Pompe disease treatment solutions are widely expected to spur growth of the global Pompe disease treatment market.

Market segmentation

Global Pompe Disease Treatment Market has been segmented on the different basis. Based on Type the market has been segmented into Late-Onset Pompe Disease, Classic Infantile-Onset Pompe Disease and Non-Classic Infantile-Onset Pompe Disease. Based on Therapy, the Global Pompe Disease Treatment Market has been segmented into Enzyme Replacement Therapy (ERT) and Gene Therapy. Based on End User the market has been segmented into hospitals & Clinics and Research & Academic Institutes. Based on region the market has been segmented into different regions like Americas covering North America ( US and Canada) and South America, Europe covering Germany, UK, France, Spain, Italy and Rest of Europe, Asia-Pacific covering China, India, Japan, Australia & New Zealand, Southeast Asia and Rest of Asia-Pacific, Middle East & Africa. The acid alpha-glucosidase is responsible for breaking glycogen, a complex form of sugar, into its simple form. The absence or mutation in the GAA gene leads to the accumulation of glycogen and damages the cells and Pompe disease is a infrequent genetic condition, caused due to the mutation in the GAA gene, which is responsible for making an enzyme called acid alpha-glucosidase. tissues. There are three chief segmentation of Pompe disease, each differing based on age and severity. These different segments are late-onset Pompe disease, non-classic infantile-onset Pompe disease, and classic infantile-onset Pompe disease. The treatment of Pompe disease is disease-specific and depends on the symptoms of the disease. The global Pompe disease treatment market on the basis of therapy has been divided into, enzyme replacement therapy (ERT), gene therapy, and others. The enzyme replacement therapy (ERT) segment captures the maximum share of the total market as it is the only Food and Drug Administration (FDA) approved therapy for the treatment of Pompe diseases. The Pompe disease treatment market has been fragmented, on the basis of end user, into hospitals & clinics and research & academic institutes. The hospitals & clinics segment was valued at USD 860.8 million in the year 2018, and the research & academic institutes segment accounted for a value of USD 320.7 million in 2018 and are expected to exhibit a CAGR of 2.3% during the forecast period.

Regional analysis

Geographically, the global Pompe disease treatment market, based on region, has been split into different regions like Americas, Europe, Asia-Pacific, and the Middle East & Africa.The Americas is responsible for the major share in the global Pompe disease treatment market owing to the grow in the number of patients with Pompe disease. As per the National Organization for Rare Disorders, the anticipated frequency of the occurrence Pompe disease is approximately 1 in 40,000 in the US. European Pompe disease treatment market is second largest market followed by Asia-Pacific. Europe responsible for the second-major market share in the Pompe disease treatment market owing to factors such as the growing research and development initiatives, support by government for the healthcare sector, and development in settlement policies have improved the market growth. Asia-Pacific is expected to be the fastest-growing region in the global Pompe disease treatment market during the forecast period. increasing healthcare expenditures, growing awareness among patients regarding rare disorders, and improved healthcare are factors which is affecting the the growth of the market. Due to low per capita income and absence of suitable healthcare infrastructure support, the Middle East & Africa responsible for a comparatively lesser market share in the year 2018

Major players

The proposed spectators in global Pompe disease treatment market are hospitals, medical devices companies, Research and academic institutes, software companies Governments, associations, industrial bodies, etc. The major companies functioning in the global Pompe disease treatment market are concentrating on firming their global ways by entering into untouched markets. The projected onlookers of the global Pompe disease treatment market are Market research and consulting service providers, Medical research laboratories and Academic medical institutes and universities, Drug Suppliers, Research and development (R&D) companies, Government research laboratories, Independent research laboratories, Government and independent regulatory authorities. Oxyrane, Valerion Therapeutics, AVROBIO, Inc., and CENTOGENE AG., Amicus Therapeutics, Inc., Genzyme Corporation, Audentes Therapeutics are some of major players in the global Pompe disease treatment market. The players operating in the global Pompe disease treatment market is focusing on product launches, along with expanding their global footprints by entering untapped markets.

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Key Features of Pompe Disease Treatment Market Research Report:

Geographically, this report is segmented into several key regions, with sales, revenue, market share and growth Rate of Pompe Disease Treatment in these regions, from 2015 to 2023, covering

Pompe Disease Treatment Market Research/Analysis Report Contains Answers to your following Questions

Purchase this Report (Price 4450 USD for Single User License) https://www.marketreportsworld.com/purchase/14139380

Lastly, this report covers the market landscape and its growth prospects over the coming years, the Report also brief deals with the product life cycle, comparing it to the relevant products from across industries that had already been commercialized details the potential for various applications, discussing about recent product innovations and gives an overview on potential regional market shares.

Total Chapters in Pompe Disease Treatment Market Report are:

Chapter 1 Overview of Pompe Disease Treatment Market

Chapter 2 Global Market Status and Forecast by Regions

Chapter 3 Global Market Status and Forecast by Types

Chapter 4 Global Market Status and Forecast by Downstream Industry

Chapter 5 North America Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 6 Europe Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 7 Asia Pacific Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 8 Latin America Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 9 Middle East and Africa Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 10 Market Driving Factor Analysis of Low End Servers

Chapter 11 Pompe Disease Treatment Market Competition Status by Major Manufacturers

Chapter 12 Pompe Disease Treatment Major Manufacturers Introduction and Market Data

Chapter 13 Upstream and Downstream Market Analysis of Pompe Disease Treatment Market

Chapter 14 Cost and Gross Margin Analysis of Pompe Disease Treatment Market

And Continued

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Market Reports Worldis the Credible Source for Gaining the Market Reports that will Provide you with the Lead Your Business Needs. Market is changing rapidly with the ongoing expansion of the industry. Advancement in the technology has provided todays businesses with multifaceted advantages resulting in daily economic shifts. Thus, it is very important for a company to comprehend the patterns of the market movements in order to strategize better. An efficient strategy offers the companies with a head start in planning and an edge over the competitors.

CONTACT US

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Email: [emailprotected]

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Molecular Diagnostics Market Economic Impact 2020: Key Trends, Challenges and Standardization, Research, Key Players with Market Dynamics and Forecast…

Global Molecular Diagnostics Market report comprehensively analyzes the Global Molecular Diagnostics market status, supply, sales, and production. The Molecular Diagnostics market shares of production and sales are evaluated along with the review of the production, capacity, sales, and revenue. Various aspects such as Molecular Diagnostics import or export, price, gross margin, consumption, and cost are also analyzed. On the whole, the report covers the Molecular Diagnostics market view and its growth probability for upcoming years.

Get a sample copy of the report https://www.marketreportsworld.com/enquiry/request-sample/14139383

Molecular Diagnostics Market report briefs all challenges and opportunities in the Molecular Diagnostics market. The study discusses Molecular Diagnostics market key events, new innovations, and top players strategies. The user gets wide knowledge and deep perceptive of Molecular Diagnostics restraints, distinct drivers, and factors impacting the industry. So that they can plan their growth map of the Molecular Diagnostics industry for the coming years.

Molecular Diagnostics Market Research Report: Information by Product (Reagents & Kits, Instruments and Services & Software), by Technique (Polymerase Chain Reaction (PCR), Isothermal Amplification, Hybridization, Sequencing, Microarray and others), by Application (Infectious Diseases, Oncology, Genetic Tests and others), by End User (Hospitals & Clinics, Diagnostic Laboratories and others) and by Region (Americas, Europe, Asia-Pacific and the Middle East & Africa) Global Forecast till 2025

Market analysis

Generally, Molecular diagnostic tests have begun a transformation in the diagnosis and checking of infectious diseases over the past several years. Various molecular diagnostic tests such as microbial phenotypic characteristics, chromatographic profiles, bio typing, and vulnerability assessment are most generally used in laboratories for the exposure and diversity of infectious illnesses. But nucleic acid practices and polymerase chain reaction (PCR) are most usually used to carry out testing for communicable diseases. As delineated, molecular analytic is a anthology of skills used to investigate biological markers in genome and proteome. It improves to diagnose and monitor diseases and helps determine which therapy should be administered to the patient. However, the growing frequency of the infectious virus, increasing awareness regarding molecular diagnostic techniques, and development in molecular diagnostics are the primary factors responsible for market growth during the projection period. PCR-based systems are used to detect the etiologic agents of disease directly from clinical samples without the use of culture media. This system is useful in the quick detection of unculturable or fastidious microorganisms. Other significant advances include the determination of viral load and the direct exposure of genes or gene changes accountable for drug resistance. Increased use of automation and user-friendly molecular diagnostic software makes these knowledges more broadly accessible in the marketplace. As a soaring prevalence of infectious disease is detected, the call for molecular diagnostic scanning is also increasing. Overall there has been a notable increase in the number of new and ongoing molecular diagnostic tests as linked to earlier years. Hence, the demand for molecular diagnostics is projected to grow in the future.

Market segmentation

The Global Molecular Diagnostics Market has been segmented into product, technique, application, end user and by region. In June 2019, company QIAGEN and McKesson penetrated a delivery contract for the supply of QIAstat-Dx Syndromic Testing Solution to smaller hospitals and other end users in the US. This augmented the delivery network of QIAGEN and McKesson. Additional company in the report can be provided are Bio-Rad Laboratories Inc., Alere, Inc., Bayer AG, Danaher, Sysmex Corporation. Based on application, the market has been bifurcated into infectious disorders, oncology, genetic tests, and others. In January 2019, Hologic, Inc., accepted the US Food and Drug Administration (FDA) approval for the Aptima Mycoplasma Genitalium Assay, used to detect ordinary sexually communicated diseases (STIs). The Aptima assay offered by Hologic, Inc., has helped to thwart the STIs in the US. By end user, the market has been categorized as hospitals & clinics, diagnostic laboratories, and others. The hospitals & clinics segment settled for a market worth of USD 4.078.09 million in 2018. By product, the market has been segregated into reagents & kits, instruments, and services & software. Based on the technique, the market has been divided into a polymerase chain reaction (PCR), isothermal amplification, hybridization, sequencing, microarray, and others. In May 2019, Clonit launched the Quanty Usutu Kit for the identification and quantification of Usutu virus. With this, the company has finalized its range of Arbovirus molecular scans.

Regional analysis

Geographically, Global Molecular Diagnostics Market is split in regions like North & Latin America, Europe, Asia-Pacific, Middle east and Africa and Rest of the world. the companies operating in the market are mainly focusing on mergers & purchase, which is likely to support market progress. Asia-Pacific is anticipated to be the sharpest-expanding market owing to emerging nations such as China, India, and South Korea emerging as major purposes for the subcontracting of clinical trials, drug production, and pathology assessment. In addition to this, improving healthcare infrastructure has increased the researches being conducted in the region. Additionally, in Asia-Pacific, China settled for a market share of 21.4% in 2018. The molecular diagnostics market in the Middle East & Africa is projected to witness steady growth during the evaluation period due to a lack of understanding of healthcare amenities. In Addition, the global molecular diagnostics market, based on region, has been apportioned into the Americas, Europe, Asia-Pacific, and the Middle East & Africa. The Americas is estimated to dominate the global molecular diagnostics market for the duration of the prediction period. This is attributed to the increasing geriatric population and the availability of advanced healthcare amenities in the region. The Europe market for molecular diagnostics is projected to be the second biggest during the projection period. The accessibility of assets for research & development and rising support from the government for the life science sector are anticipated to improve the expansion of the market in this province.

Major players

The proposed spectators in the Global Molecular Diagnostics Market are Medical device manufacturers and distributors, Retailers, distributors, wholesalers, Investors and trade experts, Governments, associations, industrial bodies, etc. The major companies functioning in the Global Molecular Diagnostics Market are concentrating on firming their global ways by entering into untouched markets. The projected onlookers in the Global Molecular Diagnostics Market are companies like Hologic, Inc.; QIAGEN; Becton, Dickinson and Company; Abbott Laboratories; Cepheid; F. Hoffmann-La Roche Ltd Thermo Fisher Scientific; Agilent Technologies and Siemens. The key strategies followed by the players operating in the global molecular diagnostics market were innovation, product development, acquisition, and expansion.

Enquire before purchasing this report https://www.marketreportsworld.com/enquiry/pre-order-enquiry/14139383

Key Features of Molecular Diagnostics Market Research Report:

Geographically, this report is segmented into several key regions, with sales, revenue, market share and growth Rate of Molecular Diagnostics in these regions, from 2015 to 2023, covering

Molecular Diagnostics Market Research/Analysis Report Contains Answers to your following Questions

Purchase this Report (Price 4450 USD for Single User License) https://www.marketreportsworld.com/purchase/14139383

Lastly, this report covers the market landscape and its growth prospects over the coming years, the Report also brief deals with the product life cycle, comparing it to the relevant products from across industries that had already been commercialized details the potential for various applications, discussing about recent product innovations and gives an overview on potential regional market shares.

Total Chapters in Molecular Diagnostics Market Report are:

Chapter 1 Overview of Molecular Diagnostics Market

Chapter 2 Global Market Status and Forecast by Regions

Chapter 3 Global Market Status and Forecast by Types

Chapter 4 Global Market Status and Forecast by Downstream Industry

Chapter 5 North America Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 6 Europe Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 7 Asia Pacific Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 8 Latin America Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 9 Middle East and Africa Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 10 Market Driving Factor Analysis of Low End Servers

Chapter 11 Molecular Diagnostics Market Competition Status by Major Manufacturers

Chapter 12 Molecular Diagnostics Major Manufacturers Introduction and Market Data

Chapter 13 Upstream and Downstream Market Analysis of Molecular Diagnostics Market

Chapter 14 Cost and Gross Margin Analysis of Molecular Diagnostics Market

And Continued

Browse complete table of contents at https://www.marketreportsworld.com/TOC/14139383

About Us:

Market Reports Worldis the Credible Source for Gaining the Market Reports that will Provide you with the Lead Your Business Needs. Market is changing rapidly with the ongoing expansion of the industry. Advancement in the technology has provided todays businesses with multifaceted advantages resulting in daily economic shifts. Thus, it is very important for a company to comprehend the patterns of the market movements in order to strategize better. An efficient strategy offers the companies with a head start in planning and an edge over the competitors.

CONTACT US

Name: Ajay More

Email: [emailprotected]

Phone: US +1 424 253 0807 /UK +44 203 239 8187

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Edited Transcript of TECH.OQ earnings conference call or presentation 4-Aug-20 1:00pm GMT – Yahoo Finance

Minneapolis Aug 4, 2020 (Thomson StreetEvents) -- Edited Transcript of Bio-Techne Corp earnings conference call or presentation Tuesday, August 4, 2020 at 1:00:00pm GMT

* Charles R. Kummeth

Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst

Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst

SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst

Good morning, and welcome to the Bio-Techne Earnings Conference Call for the Fourth Quarter of Fiscal Year 2020.

I would now like to turn the call over to David Blair -- David Claire, Bio-Techne's Senior Director, Investor Relations and Corporate Development.

David Clair, Bio-Techne Corporation - Senior Director of IR & Corporate Development [2]

Good morning, and thank you for joining us. On the call with me this morning are Chuck Kummeth, Chief Executive Officer; and Jim Hippel, Chief Financial Officer of Bio-Techne.

Before we begin, let me briefly cover our safe harbor statement. Some of the comments made during this conference call may be considered forward-looking statements including beliefs and expectations about the company's future results as well as the potential impact of the COVID-19 pandemic on our operations and financial results. The company's 10-K for fiscal year 2019 identifies certain factors that could cause the company's actual results to differ materially from those projected in the forward-looking statements made during this call. The company does not undertake to update any forward-looking statements as a result of any new information or future events or developments. The 10-K as well as the company's other SEC filings are available on the company's website within its Investor Relations section.

During the call, non-GAAP financial measures may be used to provide information pertinent to ongoing business performance. Tables reconciling these measures to most comparable GAAP measures are available in the company's press release issued earlier this morning on the Bio-Techne Corporation website at http://www.bio-techne.com. I will now turn the call over to Chuck.

Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [3]

Thanks, Dave, and good morning, everyone. Thank you for joining us for our fourth quarter conference call.

With the COVID-19 pandemic in full swing, we just finished the most challenging quarter in my tenure at Bio-Techne and perhaps the most challenging in the history of the company. Despite the challenges that COVID-19 has brought to all our stakeholders, namely our customers and employees, we persevered through the last quarter of our fiscal 2020 year by outperforming the expectations we set 1 quarter ago and maintaining a high level of profitability and positive cash flow, all while pivoting a large number of our technical resources toward developing products that will help our customers and society at large, eventually defeat this virus.

I'll cover the highlights of these initiatives in a moment, but first, a high-level review of our overall results for the quarter and the fiscal year. In Q4, our organic revenue decreased by 8%, outperforming our initial expectations for a decline of somewhere between 10% and 20%. We estimate COVID-related products provided a 5% tailwind during the quarter. This tailwind came from products produced by every division in the company, which play a key role in enabling researchers to better understand COVID-19, develop therapies and vaccines to combat the virus as well as screen and diagnose infected patients.

Overall, business trends improved as Q4 progressed with sales declines in the low to mid-teens for the month of April and May and then improving quite significantly in June to low single digit declines. However, the swings by end markets and regions were more pronounced. For example, academic end markets experienced a much more severe trough early in the quarter and have been slower to come back to normal. While from a regional perspective, Europe bounced back towards the end of the quarter ahead of the U.S., this makes sense given that Europe experienced a worse of the economic shutdown before the U.S., and so far seems to have more effectively contained the virus spread. As we all know, the spread of the virus and the containment techniques that go along with it, is a very fluid situation. So we are not out of the woods yet, but I'm encouraged by the improving business trends we experienced exiting the quarter and into July.

Given these challenging and uncertain business conditions, we kept our expenses in check, balancing our spending on growth initiatives and our commitment to keeping the Bio-Techne team intact with strict attention to discretionary spending. This financial discipline enabled us to finish the quarter with an adjusted operating margin of 31.1%, clearly not what we expect long-term but respectable given the current environment. We view the virus impact on our business as transitory and remain confident in our ability to return to at least 40% adjusted operating margins as COVID-related headwinds subside, and we execute on our long-term strategic plan.

Prior to the pandemic, we were on track to deliver another year of double-digit organic growth in fiscal 2020. But with COVID, we finished the year with 4% organic growth. However, when our customers all eventually returned to their labs and clinics, our growth pillars, namely, Cell and Gene Therapy, Exosome Diagnostics, Genomics RNAscope and our portfolio of ProteinSimple branded instruments position Bio-Techne to return quickly to a double-digit organic growth profile. And now layering in the potentially long-term tailwinds from our new COVID portfolio gives us incremental confidence in our ability to return to our targeted growth trajectory.

Before I update you on our key strategic growth and COVID-related activities, I do want to highlight our performance in China. As you know, COVID impacted China most severely back in February and March when government-mandated lockdowns were enforced. You will remember from our last earnings call that our China business still managed to grow in the mid-single digits during that very difficult environment. While I couldn't be happier to report that in Q4 organic growth in China was back over 20%, our China team has done a phenomenal job adopting to the new normal, leveraging webinars and online meeting tools to stay in front of their customers and drive the business forward as the country emerges from the pandemic. As we started fiscal '21, we could see growth slow a bit from its Q4 pace as resurgence of the virus has flared up in places like Beijing and Hong Kong, but over the long term, our China business remains in the early innings of its growth trajectory, and there is runway for many more years of 20% annual growth ahead.

Now an update on our growth in COVID-19 initiatives, starting with the Protein Sciences segment and our core reagents. Our team quickly recognized the need to help our customers conduct their research in all aspects of COVID-19 and responded by ramping production of related proteins, antibodies, small molecules and assays already found in our catalog. They also developed dozens of new products to support research of this novel virus and are continuing to do so. Within our instruments portfolio, production of our Simple Plex platform was also ramped to meet the soaring demand for Ella instruments and its highly sensitive automated immunoassays that are being used to manage patient care associated with the cytokine storm syndrome often found in severely infected patients. With year-on-year growth approaching 100% for this platform in Q4, our operating teams did an outstanding job keeping up with the demand. Also, our biologics platform continued to grow exceedingly well with solid double-digit growth both in Q4 and the full year. We have high-growth expectations for this platform as it continues to expand its application base from traditional biological drug production quality and control into Cell and Gene Therapy applications. Our Biologics portfolio with its subvisible particle characterization analytical capabilities is also seeing strong interest from vaccine developers, enabling them to better understand their manufacturing and [profitability] processes. Speaking of Cell and Gene Therapy, we continued to make progress on the construction of our newly dedicated GMP protein factory. Construction of the facility remains on track provide GMP proteins in large-scale to our Cell and Gene Therapy customers by the second half of fiscal 2021. In the meantime, our GMP protein portfolio continues to expand at a very rapid pace, nearly 100% in Q4, which now includes a number of immune cytokines typically used to grow cells for clinical trials. During the quarter, we also launched GMP ProDots. This disruptive product allows still addition of our renowned R&D systems GMP proteins to culture vessels and Cell and Gene Therapies. As a reminder, earlier this year, we entered into a commercial consortium with Wilson Wolf and Fresenius Kabi that Offers easier access to a complete and simplified Cell and Gene Therapy workflow solution using products from all 3 parties. This workflow includes Fresenius Kabi's logo instrument for leukophoresis, Wilson Wolf GRx bioreactor, and Bio-Techne's cloud cell activation, TcBuster (inaudible) and GMP proteins. During Q4, the JV made additional progress establishing a unified sales structure, a customer-facing website and point-of-sale and creating more impactful marketing collateral, featuring all 3 parents offerings. We believe the JV is well positioned to take share in this emerging therapeutic market.

Moving on to our Diagnostics and Genomics segment, where I'm happy to report that we managed not to decline in revenue this past quarter despite the COVID shutdown headwinds. I'm even more pleased to report that the segment actually expanded operating margins over last year by more than 200 basis points and increased operating profit by 20%. While our genomics products were severely impacted by the closure of academic labs, our team was able to partially mitigate this shortfall by producing and selling hundreds of RNAscope probes for COVID-19 virus detection and tissue, allowing researchers to confirm the organs that are successful to this virus.

Our Diagnostics research division was able to deliver a solid mid single-digit growth in the quarter despite customer delays in ordering controls and calibrators used for routine diagnostics tests used by clinicians. Our team was able to more than offset this shortfall by supplying specialty diagnostic antibodies and other raw materials to COVID-19 testing manufacturers.

And in Exosome Diagnostics, we validated and launched the COVID-19 realtime qPCR test in our labs, both in Waltham, Massachusetts and Munich, Germany. Following the implementation of processes and instruments to automate the test, we will be able -- we will be capable of scaling testing capacity to several hundred samples per day. This lab-developed test will provide rapid and reliable detection of patients with active COVID-19 infections, especially in the Boston area. However, Exosome Diagnostics also experienced headwinds related to COVID-19 as ExoDx prostate test volume was severely impacted by the near complete shutdown of urologist offices.

As we announced last quarter, the team responded by launching an at-home collection kit in Q4 for our ExoDx prostate test, enabling men unable to visit their urologist office to have access to a test and the knowledge of whether a biopsy should be prioritized. The at-home collection kit was launched with a patient-targeted marketing strategy, including search engine optimization, a Facebook campaign and webinars to drive awareness that patients do not need to go into the urologist office to have access to this valuable test. We believe the flexibility of providing a year-end sample at the convenience of the patient will be yet another key differentiator of the ExoDx prostate test from the competition. The response to our at-home collection kit has been very positive with both patients and urologists, and already consists of more than 10% of our current test volume. The impact of the at-home test collection kit, our push-pull cart marking strategy and the gradual reopening of urologist offices, has had a positive impact on our EPI test volume since it bottomed in April, with June daily test counts approximately 75% of pre COVID test monthly run rate and continue to show improvement in July.

Before I turn the call over to Jim for his financial review, I want to provide an update on what could be our biggest COVID-19-related initiative to date, our co-branded R&D system, Mount Sinai COVID serology assay test. During the quarter, we announced a collaboration with Kantaro Biosciences, a Mount Sinai led joint venture to manufacture and commercialize the serology assay based on Mount Sinai's test. This was a tremendous effort by both the Bio-Techne and Mount Sinai teams, convincing the typical 18-month ELISA kit development time frame to just 6 weeks. This 2-step serology test is a truly differentiated offering going beyond the qualitative information provided by other COVID serology assays on the market, with the second step providing a tighter or measurement of the antibodies present to neutralize the virus. This second step completely eliminates false positives, with Mount Sinai's assay having a 100% positive predictive value, or PPV, and 99.6% negative predictive value, or NPV. To date, diagnostic activity is focused on PCR or antigen based test to detect active COVID-19 infections. We believe serology test volumes will increase as the second wave of testing emerges focusing on the surveillance activities necessary to reopen the economy and to help better manage vaccination programs once available.

Yesterday, Kantaro Biosciences submitted a request to the FDA for an emergency use authorization, or EUA, for quantitative use of our serological assay. We anticipate the EUA process to be complete in mid- to late August. Kantaro and Bio-Techne have joined forces to develop marketing materials, a branding and go-to-market strategy for the assay, highlighting the unique quantitative information provided as well as the best-in-class performance of the assay. We are ready to launch this assay upon receipt of the EUA and have the capacity to produce millions of tests per month as needed.

Also yesterday, we announced the launch of a COVID sero index, a research use only, or RUO version of the 2 step serology assay. This assay is designed to meet the current vaccine developer needs for an objective measurement of immune response to a vaccine, making the test ideal for identifying the most potent vaccine candidates determining optimal dosing, identifying the appropriate vaccine schedule and when boosters may be needed.

In summary, I'm extremely proud of the way the team responded to a challenging business environment in the fourth quarter. Our end market showed steady improvement as the quarter progressed and has continued to improve in July with our academic and biopharma end markets reopening and our COVID-related products seeing continued traction. We are on the cusp of launching the first commercial quantitative IgG COVID-19 serology assay, which has potential to answer many of the important questions necessary to reopen our economies further and push the best vaccines forward.

We are entering fiscal 2021 in a positive -- sorry, in a position of financial strength, with a portfolio of best-in-class products targeting high-growth and underpenetrated market opportunities. We are ready to continue to execute on our long-term strategic plan. With that, I will turn the call over to Jim.

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James T. Hippel, Bio-Techne Corporation - Senior VP of Finance & CFO [4]

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Thanks, Chuck. I'll provide an overview of our Q4 fiscal 2020 financial performance for the total company, provide some additional color on the performance of each of our segments and give some initial thoughts on the pace of business recovery from the pandemic in the near term.

Starting with the overall fourth quarter performance. Adjusted EPS was $1 versus $1.25 1 year ago, with foreign exchange negatively impacting EPS by $0.01. GAAP EPS for the quarter was $1.48 compared to $0.42 the prior year. The biggest driver for the increase in GAAP EPS was unrealized gains on our investment in ChemoCentryx this year compared to unrealized ChemoCentryx losses in the prior year.

Q4 revenue was $175.8 million, a decrease of 8% year-over-year on a reported and organic basis. Foreign exchange translation and acquisitions had an immaterial impact on our revenue. For the full year fiscal 2020, revenue was $738.7 million, an increase of 4% on a reported and organic basis. By geography in Q4, the U.S. declined approximately 20% while Europe declined approximately 4% as European customers shut down their labs earlier than the U.S. and then reopened them faster later in the quarter.

As Chuck mentioned, China had a remarkable quarter with organic growth increasing 24%. As for the rest of Asia, organic growth declined mid-single digits, with almost all countries in some way being negatively impacted by the pandemic. By end market, biopharma declined mid-single digits, while academic sales decreased by nearly 30%.

Moving on to the detail of the P&L. Total company adjusted gross margin was 69.5% in the quarter compared to 71.9% in the prior year. The decrease was due to unfavorable volume leverage and mix. Adjusted SG&A in Q4 was 28.9% of revenue, a 60 basis point increase compared to the prior year due to unfavorable volume leverage. I do want to point out that our adjusted SG&A spend was down nearly $3.5 million from the prior year, highlighting our discipline on discretionary spend while keeping our teams intact with no furloughs or reductions enforced. For GAAP reporting, SG&A expense in the current period also reflects an approximately $7 million gain on settlement of the escrow balance associated with the Exosome acquisition. This is accounted for as a reduction in SG&A in Q4 of fiscal year '20.

R&D expense in Q4 was 9.5% of revenue, 100 basis points higher than the prior year due to unfavorable volume leverage and investments in COVID-19-related product development. Here, our adjusted spending was about $0.5 million higher than the prior year, emphasizing our conviction to continue to invest in the business for the long term. The resulting adjusted operating margin for Q4 was 31.1%, a decrease of 400 basis points from the prior year period.

Looking at the numbers below operating income. Net interest expense in Q4 was $4.4 million, decreasing $0.8 million compared to the prior year period. The decrease was due to a substantial reduction of our bank debt during fiscal 2020. Our bank debt on the balance sheet as of the end of Q4 stood at $357 million.

Other adjusted nonoperating income was $0.5 million for the quarter compared to $0.1 million from Q4 last year, primarily reflecting the foreign exchange impact related to our cash pulling arrangements. For GAAP reporting, other nonoperating income includes unrealized gains from our investment in ChemoCentryx.

Moving further down the P&L. Our adjusted effective tax rate in Q4 was 21.4%, similar to the prior year in what we expect for the foreseeable future.

Turning to cash flow and return of capital. $44.8 million of cash was generated from operations in the quarter, down 20% over Q4 of last year and consistent with our adjusted earnings. In Q4, our net investment in capital expenditures was $17.3 million, primarily driven by construction of our new GMP protein factory, which remains on schedule for completion by the end of the calendar year. During Q4, we returned capital to shareholders with $12.3 million of dividends. We finished the fiscal year with 39.7 million average diluted shares outstanding.

For the full fiscal year, cash flow from operations was $205.2 million, up 13% from our fiscal 2019 result. Our net investment in capital expenditures was $51.7 million, consisting of $24.1 million in baseline CapEx and a $27.6 million investment in our GMP protein facility.

Our balance sheet remains very strong with $270.9 million in cash and short-term available for (inaudible) investments and the total leverage ratio of well under 1x EBITDA. Our total leverage is at the lowest level since before the 2014 acquisition of ProteinSimple.

Next, I'll discuss the performance of our reporting segments, starting with Protein Sciences. Q4 reported sales were $127.3 million, with reported revenue decreasing 11%. Organic growth also decreased 11% with foreign exchange and acquisitions having a negligible impact on revenue growth. Within this segment, product lines with higher academic exposure, namely our reagent solutions portfolio, experienced significant headwinds. As Chuck mentioned, we had an exceptional quarter in both the Biologics and Simple Plex instrument platforms, which partially offset the impact of lab closures due to the pandemic. Operating margin for the Protein Sciences segment was 38.9%, a decrease of 650 basis points year-over-year due primarily to the unfavorable volume leverage and to a lesser extent, unfavorable product mix.

Turning to the Diagnostics and Genomics segment. Q4 reported sales were $48.7 million, relatively flat with the prior year results. Organically, revenues grew 1%, with foreign exchange translation having an unfavorable 1% impact on revenue. Within this segment, our Diagnostic Reagent division increased mid-single digits with strong COVID-19-related raw material tailwinds benefiting the business. Meanwhile, our Genomics division, which like our Research Solutions division and Protein Sciences, has a large exposure to the academic market and took the biggest COVID-related hit in the segment with a double-digit percentage decline in sales in Q4. However, as labs gradually started to open throughout the quarter and into July, we've also seen Genomics performance dramatically improve. Additionally, we anticipate the launch of micro RNAscope, increased penetration of high-plex and continued adoption of RNAscope for COVID-19 applications to positively contribute to growth going forward.

Finally, Exosome Diagnostics' Q4 revenue increased over 80% from last year, with higher collections from Medicare, private payers and patients as well as progress with biopharma partnerships driving the year-over-year increase. Keep in mind that Exosome is still on a cash basis for revenue recognition, so collections from pre pandemic test helped the recorded sales in the quarter.

Moving on to operating margin for the Diagnostics and Genomics segment, at 12.4%, the segment's operating margin improved from 10.3% reported in the prior year. The increase reflects [stable] volume leverage in our Diagnostics Reagents division, less dilution from Exosome Diagnostics as well as strong cost management.

Before we turn the call over to Q&A, I will share our current perspective of our view ahead. First and most importantly, our strategic financial goals for the next 3 to 5 years remain unchanged. Our novel automated protein analytical capabilities, our cutting-edge tissue and liquid biopsy technologies, our toolkit of Cell and Gene Therapy manufacturing solutions, together with our core world-class protein reagents, are as well positioned ever to help our customers advance the study of life sciences. And we believe in a post-COVID world, the need to advance the study of life sciences will be greater than ever before. This gives us even greater confidence in achieving our long-term financial goals. But first, our customers, namely life science researchers and diagnostic practitioners, need to all get back to work. This is starting to happen as our monthly pacing of sales recovery within Q4 made clear. However, there are still too many unknowns about what the impact of the pandemic and any potential vaccines will have on our lives this fall and winter. This uncertainty prevents us from giving a view on our full fiscal year '21 financial performance with any sort of confidence [intervals]. So we are managing our outlook month-by-month, quarter-by-quarter, staying nimble to deploy resources for the needs of our customers as they arise. As a reminder, our first quarter of fiscal year '20 was very strong and will likely be the toughest comparable for the upcoming year. Thus, holding flat year-over-year in Q1 on both the top and bottom line, we see as the right trajectory to keep us on track to our long-term plan. The downside risk of this trajectory would be a pause or reversal in our customers going back to work due to a worsening of the pandemic. An upside of this trajectory would be regulatory approval of our quantitive COVID serology assay test, coupled with an early successful commercial launch.

That concludes my prepared comments, and with that, I'll turn the call back over to the operator to open the line for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Our first question comes from Puneet Souda with SVB Leerink.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [2]

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So first question is on guide, if you can just elaborate a little bit on the first quarter scenario here that you're presenting flat. Just trying to get a better understanding of what sort of trends are you seeing in July that give you this view? Or is there -- one would have expected the academic labs to continue to improve. And if we do so -- slightly better than flat, is that not something that is doable despite the tough comps here. This is my first question and I have a few follow-ups.

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [3]

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Sure. Well, first and foremost, we finished this last quarter still down 8% and it could have been worse than that. We did have a tailwind. THe tailwind's improving. We're seeing a resurgence in July, not -- towards this summer we saw with China coming back. So July numbers are a very good start, as Jim alluded to. But there's 2 months to go, and we have a 13% comp from last year to cover. So that's the big one. So coming back from negative coming this quarter in a tough comp, we think flat, we could give a range. We were 9% or 10% minus 20% last quarter. We talked about saying something from 0 to 10% or something or a minus 5% to plus 5%. But I think the best thing is to keep this tight as we can. We think flat's the right trajectory for us. And if there are upsides -- now if we stay with what we see in July, continue into the whole quarter, I think there'll be upside. I agree we did see it in China. We saw things level off, and expect to see things level out here, too. I mean, we're seeing a really strong start in the quarter. And it's just probably not plausible. Not to mention there are hotspots and resurgence going on, and they're just very unpredictable what's going to happen. I know that I looked at the numbers this morning and looks very encouraging in the U.S. for the numbers this week but who is to say it. So I think on top of the comp, I think flat is right. Europe continues to progress to be a little bit ahead of us. U.K. is the only real out liar here, and we'll have to watch and see what happens there. And in China, it's actually a little bit going the wrong direction right now, right? So if that gets worse, we'll see. India and others are not as bad as I would have thought, given their population and their ability to actually deal with this, but that's a good thing. And then on top of all this, there's upside on our COVID, right? So if we get our EUA in 2 to 4 weeks, and we get a solid month of coming out with this product, that's really not in our numbers, in this forecast. So there's upside. We have other COVID products as well. Simple Plex, we talked about had just an amazing quarter, and it's looking like it's going to continue maybe not quite at 100% growth, but darn good growth I guarantee you. So we need academia to come back, we need urologists to come back, and the progression has started, but it's not -- they're not all the way back even at the end of this quarter, we don't think so. We're going to stay cautious. We don't officially give guidance. This is the closest we've ever come, and we're talking about staying flat against a strong comp, that's all. That gives you something, Puneet.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [4]

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I appreciate the details there. And my next question is serology. I think this is a question that we've been getting from investors as well. What is your expectation here for contribution from serology in fiscal year '21? And I'm asking that because COVID serology market has lagged significantly behind the PCR market given that PCRs more has essentially more diagnostic capabilities. Obviously, serology is only giving you a snapshot in time. So -- and some of the peer companies have also lowered their expectations in serology significantly going into the next quarter. So I'm wondering what are you baking in for serology? And what gives you confidence that you can grow sort of above the market here in serology?

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [5]

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Sure. Well, I want to give you some comments here, and they're really meant for everybody, not just you. So (inaudible) cover the same ground here, and then questions later and that we will get this out kind of to all of you at once just to be really careful. We've invested a lot in our test. We have submitted a one hell of a dossier to the FDA, let me tell you. And it is an incredible data package. We have gone far and beyond, really what the FDA requires for something like this. As you know, it's a 2 step. When we decided to go fully quantitative a couple of months ago and take a step back and take some extra time, the FDA, first of all, was starting to get clogged up with an awful lot of request; two, being we're talking about asking for a fully quantitative EUA and nobody else has done that. And they really, really asked for an awful lot of extra stuff, extra data, extra testing. We have complete sensitivity data done. We did crossed reactivity test against 14 major diseases. We have stats on all this that are phenomenal. We know of nothing out there that compares, but we don't maybe know everything that's coming out either. So we're only (inaudible) there now. We do also know and the FDA, regrettably so, knows that they've issued a lot of preliminary EUAs that they probably regret and a lot of these initial qualitative tests have become a tarnish to the whole serology potential. And we have to overcome that. But we're very sure and we're very clear on the fact there's a need for a quantitative serology test that really can identify the level of immunity in a patient. And this is going to be important. More and more important as these vaccines come in the market, and patients who want to know, are they having a response or not. And so we see a surveillance side of this, it's going to only grow, and it's not going away in a year. So will it match the -- are you sick now testing environment to PCR, maybe not. But it's going to be a very large market, and we're not a very big company, and we're going to have the best test, at least for a while. So we're very confident that we're going to be treated very fairly by the FDA, and we'll be out there before this quarter end, hopefully. But there's no guarantee. This is the FDA, and there are hundreds of tests out there, trying to get in, in all different forms. We know of nothing else out there that can match us. We had incredible partners with Kantaro and then Mount Sinai. They are managing most of the bureaucracy here being -- we're not that experienced at it. And we've got great consultants on the staff through Kantaro as well who've really taken control of our dossier and our package, our data, everything. Our team here at Bio-Techne has worked around the clock for months now and has really fulfilled their mission, we feel. And we're ready to go. And we're not kidding, we're ready to go at millions per month, if not millions per week. So -- but you're right. Right now, it's kind of a 10% kind of market demand compared to [PCR], but we think it'll improve. And it will improve with the test getting better with vaccines coming on the market and the economy is opening up, and people want to go back to work, and knowing they're safe to go back to work. So we're ready. We've been waiting for this, and we're ready.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [6]

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That's very helpful. And my last one is on Cell and Gene Therapy. This is obviously an important growth driver in new market opening for you here for the next few years. So when is the earliest we can see the revenue in that? And maybe if you can provide some details or anything we should be modeling? And how should we be looking for that in 2021? And if you could also provide any updated thoughts on the level of interest you're seeing and early commitments to -- for the capacity that you are building out in the first year? If you could provide some color there, that would be helpful.

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [7]

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Well, as you know, we're selling GMP proteins now. We're just not selling in larger batches. So our GMP protein business is growing and growing near 100%. So we'll be moving all of that over to the facility once we are able to. So we're on schedule, on budget. We'll be opening the facility in late September, qualifying for the rest of this calendar year and be open for business for scaled out production revenue, probably in January or something. We have a one completed, signed up large customer, and we are in negotiations with half a dozen others. And behind that are a lot more others on preclinicals and testing and people getting ready to check us out. So it's hard to guess right now what that first year revenue will be coming out of the factory, but it's certainly going to be significant. We will fill not show our capacity for first year. We've never said we would be. Probably say, it could take as long as 5 years to a full $140 million. We don't think it will take that long, but it could. Our models don't go beyond that. So it'll only be upside. So we're ready to expand it to a $200 million model. And it takes about a 6-month to 1 year window to do that. So we think we have ample time. We've got ample room in the building. We've got ample green space. So no issues there. Equipment is all here. The site looks phenomenal. We're going to have a fantastic viewing quarter for the processes. Our local Minnesota Science Museum, who is the world or the country leader in exhibition design, they say this is for sale, they're going to help us design how to exhibit and how to show the processes. So it will be a great venue for customers to come in and see what they can expect. And it's going to be fun. So everything is on track. The numbers don't -- haven't changed since we've told you before really, so.

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James T. Hippel, Bio-Techne Corporation - Senior VP of Finance & CFO [8]

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Puneet, the other thing I'll add with regards to the GMP factory itself in terms of the revenue generated from it. Aside from just the growth in our normal clinical business, as Chuck mentioned, where it's growing at 100% for GMP proteins, these large customer deals that we either signed or are in negotiations with right now, they're all in various phases of [clinicals] right now. They are not commercializing themselves yet. So the reality is until they get through their Phase III and commercialize, we really won't have a good view of the timing of when we'll see that major step-up in revenue from those customers.

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [9]

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And these are ones that aren't really out there out or coming out. As you know, there's an awful lot of viral vector based cell therapies coming out the next year or 2. And we're not really -- we're not in those clinicals. But being we're not part of the drug, it would take just equivalency testing to actually move over our protein if it's deemed to be a better value, better quality, et cetera. So we expect, as we open, we'll get more and more interest from dozens and dozens of cell therapies that will be coming over the next 2 to 3 years. That's our angle anyway.

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Operator [10]

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Our next question comes from Catherine Schulte with Baird.

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Catherine Walden Ramsey Schulte, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [11]

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I guess, first, just on China, great to see that strong return to growth in the quarter. You talked about seeing that reverse to some extent. I guess what's implied for China and the flat overall guide for the first quarter?

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Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [12]

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The rest is here:
Edited Transcript of TECH.OQ earnings conference call or presentation 4-Aug-20 1:00pm GMT - Yahoo Finance

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Chapters Define in TOC (Table of Content) of the Report: Chapter 1: Market Overview, Drivers, Restraints and Opportunities, Segmentation Overview Chapter 2: COVID Impact Chapter 3: Market Competition by Manufacturers Chapter 4: Production by Regions Chapter 5: Consumption by Regions Chapter 6: Production, By Types, Revenue and Market share by Types Chapter 7: Consumption, By Applications, Market share (%) and Growth Rate by Applications Chapter 8: Complete profiling and analysis of Manufacturers Chapter 9: Manufacturing cost analysis, Raw materials analysis, Region-wise Manufacturing expenses Chapter 10: Industrial Chain, Sourcing Strategy and Downstream Buyers Chapter 11: Marketing Strategy Analysis, Distributors/Traders Chapter 12: Market Effect Factors Analysis Chapter 13: Market Forecast Chapter 14: Precision Cancer Therapies Research Findings and Conclusion, Appendix, methodology and data source To check the complete Table of Content click here: @ https://cognitivemarketresearch.com/medical-devicesconsumables/precision-cancer-therapies-market-report#table_of_contents

The qualitative contents for geographical analysis will cover market trends in each region and country which includes highlights of the key players operating in the respective region/country, PEST analysis of each region which includes political, economic, social and technological factors influencing the growth of the market. The research report includes specific segments by Type and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2015 to 2027.

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In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Precision Cancer Therapies Market Report 2020 Key Players Abbott Laboratories,...

Hemophilia Treatment Market 2020 By End-User Demand, Emerging Trend, New Innovations, Future Prospect, Detailed Analysis and Forecast 2027 – MR…

Hemophilia Treatment Market In-Depth Analysis, Regional Outlook

Hemophilia is a condition where blood does not clot, and this condition is normally inherited. The condition is caused due to defects in a gene of the X chromosome, which is a clotting factor. Generally, the diseases are widely seen in males as the X chromosome is inherited from mother to baby boy. The disease is widely treated with replacement therapy and gene therapy. The other treatment which is used is medication. However, there are ways to reduce the risk of the condition, which include regular exercise and others. The condition can be prevented by taking preventive treatment by injection of clotting factor VIII for hemophilia A, or IX for hemophilia B.

The hemophilia treatment market was valued at US$ 14,454.81 million in 2019 and is expected to grow at a CAGR of 15.9% from 2020 to 2027 to reach US$ 44,089.71 million by 2027.

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Some of the key players profiled in the study areBayer AG, Sanofi, F. Hoffmann-la Roche Ltd., Kedrion S.P.A., CSL Limited, Biotest AG, Pfizer Inc., Novo Nordisk A/S, Octapharma AG, Baxter International Inc., etc.

Hemophilia Treatment Market Trends, Growth, Future Scope

Based on end user, the hemophilia treatment market is segmented into hospitals & clinics, hemophilia treatment centers, and ambulatory surgical centers. The hospitals and clinics held the largest share of end user segment in the global market. Moreover, the same segment is expected to grow at the fastest rate during the coming years. The hospital is a complex organization or an institute that provides health to people through complicated but specialized scientific equipment. The team of trained staff in the hospital, educated in the problems of modern medical science. They are all coordinated together for the common goal of restoring and maintain good health. Medical research is constantly pushing the boundaries of health care and redefining what is and isnt possible. The hospitals offer advanced treatment options as a resource for patients for chronic and hard-to-heal wounds and surgeries to treat them. Most of the surgeries are being performed in hospitals, owing to continuous patient care and monitoring. Also, increasing government funding in the hospitals and rising hospital research drives the market growth.

The research provides answers to the following key questions:

The report profiles the key players in the industry, along with a detailed analysis of their individual positions against the global landscape. The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the Hemophilia Treatment market. The researcher provides an extensive analysis of the Hemophilia Treatment market size, share, trends, overall earnings, gross revenue, and profit margin to accurately draw a forecast and provide expert insights to investors to keep them updated with the trends in the market.

Competitive scenario:

The study assesses factors such as segmentation, description, and applications of Hemophilia Treatment industries. It derives accurate insights to give a holistic view of the dynamic features of the business, including shares, profit generation, thereby directing focus on the critical aspects of the business.

Global Hemophilia Treatment Market By Product

Global Hemophilia Treatment Market By Disease

Global Hemophilia Treatment Market By Treatment Type

Global Hemophilia Treatment Market By Therapy

Global Hemophilia Treatment Market By End User

Global Hemophilia Treatment Market By Geography

Major highlights of the report:

All-inclusive evaluation of the parent market

Evolution of significant market aspects

Industry-wide investigation of market segments

Assessment of market value and volume in past, present, and forecast years

Evaluation of market share

Study of niche industrial sectors

Tactical approaches of market leaders

Lucrative strategies to help companies strengthen their position in the market

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Hemophilia Treatment Market 2020 By End-User Demand, Emerging Trend, New Innovations, Future Prospect, Detailed Analysis and Forecast 2027 - MR...