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143,301,550 shares of the Company's common stock outstanding as of May 5, 2021.
Looks like we'll be stuck in a holding pattern until at least Q3 or with the advent of some positive news.
Thanks for passing that along.
I think there is zero chance of analyst upgrades with the status quo. If Helen doesn't impress in the next call we may even see some dopwngrades to "Hold" or worse. The most she has acomplished in the last few years is to put HALO $800 million in debt with nothing to show for it. (And, in anticipation of what some others may say, no, it's not "free money" so don't even try that with me. LOL!)
Very discouraging. No wind in our sails at this time.
That's a great summary and calls into question the HALO guidance of $1 billion in royalties by 2027.
The one thing I'd be able to add is that you are on to something regarding how darzalex was a perfect alignment of interests. The fact is that many IV drugs are not necessarily going to switch to subcu. For example, the Lilly MAB for Covid-19 only takes an hour or less, so will there be a strong market incentive to adopt a subcu version? I doubt it. So the market for Enhanz might not be as great as once thought.
Add to that the alternative subcu formulations that appear to be quietly percolating and we have a worrisome stage set while we await the next shoe to drop in this long saga.
You've nailed it as far as I'm concerned. What do you think is the heart of the problem regarding Enhanze partnerships?
I'm less certain of that nowadays, but lt's hope you're right. It's definitely within the realm of possibility.
I'm terrible at timing ins and outs so I'm stickiing with my current position. I have a large position (for me) and I'm waitng to see what the next shoe to drop is before updating my plan. I was originally going to wait until we hit $100 and cash out but with the new change in direction I'm uncertain, which I hate being.
That sounds accurate. I'm personally assuming a small end of year beat at $200 million from all sources. That would put us into the $60's by years's end.
I'm certain it's not 3%. That's just not a within the acceptable definition of "mid-single digits" and would be a materially misleading statement. I've never seen any evidence, on the other hand, that would point to them ever cracking 5%. So I thing 4% is a good conservative working hypothesis.
I've been predicting Roche buys HALO since 2006. LOL!
Still waiting and hoping, but not holdiing my breath.
I've always assumed "mid single digit royalties" translate to 4%.
If royalties are as you predict (I think you're a little optimistic but I'll go with almost $50 million for argument's sake) that translates to about $1.40 per share annually. That might get us back into the mid 50's.
The company guidance undoubtedly includes darzalex, so you can't just add on like that.
With HALO's newly inflated share count that amounts to about $.35 per share.
Sub-penny again? Oops! They did it again!
IMHO as long as working Americans continue to reject trade unions, inflation will never be a real issue.
This is really old news, so the PPS would be unlikely to be affected by it now.
Since Roche has a long-standing relationship with Enhanz (literally the longest of any partner) I find it disturbing that Enhanz is evidently not in the Covid mix.
How do you know Enhanz is in this formula?
Roche/REGN now has subcu version of Covid-19 MAB but Enhanz not mentioned in PR.
-------------------------------------------------------------
Media & Investor Release
Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%
Among individuals who still experienced symptomatic infections, those who received casirivimab and imdevimab were able to clear the virus faster and had much shorter symptom duration
In a cohort of recently-infected asymptomatic patients, casirivimab and imdevimab reduced the overall risk of progressing to symptomatic COVID-19 by 31%
Detailed results will be shared with regulatory authorities including the EMA and the FDA
Basel, 12 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The trial, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), met its primary and key secondary endpoints. It showed that the subcutaneous administration of casirivimab and imdevimab reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. In addition, individuals treated with casirivimab and imdevimab who still experienced a symptomatic infection resolved their symptoms on average within one week, compared to three weeks with placebo. No new or serious safety signals were observed.
“Today’s data confirm the potential dual value of casirivimab and imdevimab to reduce household COVID-19 infections and to decrease the disease burden in those who do become infected, when given as a subcutaneous option,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Although vaccinations are increasing globally, there remains a critical unmet need worldwide to prevent infections and provide immediate protection from COVID-19 between close contacts. This is why we are excited to bring this data to health authorities with the goal of making the combination available to more people as soon as possible.”
The phase III, double-blind, placebo-controlled trial assessed the effect of casirivimab and imdevimab on individuals without SARS-CoV-2 antibodies or any COVID-19 symptoms, who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days. It included 1,505 people who were not infected with SARS-CoV-2 at baseline and received either one dose of casirivimab with imdevimab (1,200 mg) or placebo, administered as subcutaneous injections.
In addition, the multi-part study evaluated the antibody cocktail in a cohort of 204 recently infected asymptomatic patients randomised to receive either one dose of casirivimab and imdevimab (1,200 mg subcutaneous administration) or placebo. In this cohort, casirivimab and imdevimab reduced the overall risk of progressing to symptomatic COVID-19 by 31%.
Detailed results from the trial will be shared with regulatory authorities as soon as possible. Regeneron will share new data with the United States (U.S.) Food and Drug Administration (FDA) and Roche and Regeneron will continue to work with the European Medicines Agency (EMA) and other health authorities across the globe.
The antibody cocktail continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalised and certain hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the UK. As of April 2021, more than 25,000 people have participated in clinical trials involving casirivimab and imdevimab.
In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic.
Table 1: Key results from phase III prevention cohort in uninfected individuals*
Casirivimab and imdevimab
(1,200 mg subcutaneous dose)
Placebo
n=753
n=752
Proportion of subjects with symptomatic SARS-CoV-2 infections through day 29 (primary endpoint)
Risk reduction
81%
(p<0.0001)
# of patients with events
11 (1.5%)
59 (7.8%)
Symptoms and viral load
Total weeks with symptoms
Reduction
93%
(p<0.0001)
Total # of weeks (cumulative for all individuals in each arm)
13
188
# of weeks with symptoms (mean) in symptomatic individuals
1.2
3.2
Total weeks with high viral load (>104 copies/mL)
Reduction
90%
(p<0.0001)
Total # of weeks (cumulative for all individuals in each arm)
14
136
# of weeks with high viral load (mean) in qPCR positive subjects
0.4
1.3
*Individuals without any COVID-19 symptoms who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days. Based on the seronegative modified Full Analysis Set population, which includes all randomized subjects without evidence of current or prior SARS-CoV-2 infection (i.e., a negative RT-qPCR test and a negative antibody test) at randomization.
Adverse events (AEs) occurred in 20% (n=265 out of 1,311) of REGEN-COV participants and 29% (n=379 out of 1,306) of placebo participants, and serious AEs occurred in 1% (n=10) of REGEN-COV participants and 1% (n=15) of placebo participants. There were 0 REGEN-COV participants and 4 placebo participants who were either hospitalized or visited the emergency room because of COVID-19 during the 29-day efficacy assessment period. Injection site reactions, all of which were grades 1-2, occurred in 4% (n=55) of REGEN-COV participants and 2% (n=19) of placebo participants. No individuals from either group withdrew from the trial due to AEs, and none of the deaths in the trial (2 REGEN-COV, 2 placebo) were attributed to COVID-19 or study drug.
Table 2: Key results from phase III treatment cohort in asymptomatic infected individuals
Casirivimab and imdevimab
(single 1,200 mg dose)
Placebo
n=100
n=104
Proportion of subjects with symptomatic SARS-CoV-2 infections through day 29 (primary endpoint)
Risk reduction
31%
(p=0.0380)
# of patients with events (cumulative for all individuals in each arm)
29 (29%)
44 (42%)
Symptoms, viral load and COVID-19 related events
Total weeks with symptoms
Reduction
45%
(p=0.0273)
Total # of weeks (cumulative for all individuals in each arm)
90
170
Total weeks with high viral load (>104 copies/mL)
Reduction
40%
(p=0.001)
Total # of weeks
48
82
Based on the seronegative modified Full Analysis Set population, which includes all randomized asymptomatic patients who were SARS-CoV-2 positive but had no evidence of prior infection (i.e., a positive RT-qPCR test and a negative antibody test) at randomization
Adverse events (AEs) occurred in 34% (n=52 out of 155) of REGEN-COV patients and 48% (n=75 out of 156) of placebo patients, and serious AEs occurred in 0% (n=0) of REGEN-COV patients and 3% (n=4) of placebo patients. Injection site reactions, all of which were grades 1-2, occurred in 4% (n=6) of REGEN-COV patients and 1% (n=1) of placebo patients. No patients from either group withdrew from the trial due to AEs, and there were no deaths.
About REGN-COV 2069
REGN-COV 2069 is a phase III, randomised, double-blind, placebo-controlled multi-part study assessing the efficacy and safety of casirivimab and imdevimab in preventing symptomatic infection in household contacts of individuals infected with COVID-19.
In January 2021, initial data from the trial showed that there was a reduction in overall infections seen with casirivimab and imdevimab within the first week, with approximately 50% lower overall rates of infection (symptomatic and asymptomatic) and 100% prevention of symptomatic infections. Casirivimab and imdevimab showed efficacy when administered via a low-dose (1,200 mg) subcutaneous route.
In the safety assessment of these patients, adverse events occurred more frequently in participants on placebo during the efficacy analysis period (12% in the casirivimab and imdevimab group and 18% in the placebo group) and during the follow-up period (11% in the casirivimab and imdevimab group and 20% in the placebo group).
About casirivimab and imdevimab
Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. They evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.
The two potent, virus-neutralising antibodies casirivimab and imdevimab are believed to bind non-competitively to the critical receptor binding domain of the virus's spike protein, which is hypothesised to diminish the ability of mutant viruses to escape treatment and to protect against spike variants that may arise in the human population, as detailed in Science publications.
The cocktail of casirivimab and imdevimab has not been granted a marketing authorisation by any health authority. In November 2020, the antibody cocktail was authorised by the United States (U.S.) Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalisation. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.
In February 2021, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a scientific opinion under Article 5(3) of Regulation 726/2004 supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The scientific opinion can be considered by EU member states when making decisions on the use of medicines at a national level before a formal authorisation is issued. The review under Article 5(3) was separate, but ran in parallel to the rolling review of casirivimab and imdevimab, which is currently ongoing by the EMA.
Casirivimab and imdevimab’s development, manufacturing and clinical trials have been funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services under OT number: HHSO100201700020C.
About U.S. FDA EUA status
Casirivimab and imdevimab have not been Food and Drug Administration (FDA) cleared or approved in the United States (US). It has been authorised by the FDA under an Emergency Use Authorization (EUA) during the current public health emergency for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalisation. Please see the Fact Sheet for Healthcare Providers for more information, including important safety information. The cocktail is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorisation revoked sooner.
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in their fight against COVID-19 and minimising its impact. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection, as well as providing digital support to healthcare systems. We also continue to identify, develop and support potential therapies which can play a role in treating the disease.
The impact of COVID-19 goes beyond those who contract it. That is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure patients continue to receive the tests, treatment and care they need during these challenging times. Building on a longstanding tradition of partnerships, we are working together with governments and others to make healthcare stronger and more sustainable in the future.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic and Roche has so far launched 16 diagnostics solutions to help minimise the impact of COVID-19. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work. On 13 March 2020 we became the first company to receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a high-volume molecular test to detect the virus. Since then, we have continued to add a range of diagnostics solutions to our global portfolio to help in the fight against COVID-19. In addition to the gold standard PCR test, we have developed antigen tests to help diagnose the virus in settings where there is limited molecular laboratory infrastructure, rapid antigen where the virus can be detected on the spot, tests that can test for both flu and COVID-19 at the same time, both high throughput and at the point of care, and tests that can detect virus antibodies that can help monitor the spread of the virus and can also support in vaccine development. On 16 March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations.
Aside from these tests we have also looked at how we can support care for patients who have COVID-19, receiving an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, a digital algorithm that could help simplify the screening, diagnosis and monitoring of respiratory-compromised patients with COVID-19. Roche is working closely with governments and health authorities around the world, and has significantly increased production to support availability of tests globally.
Roche is actively involved in understanding the potential of the existing portfolio and is researching options for the future. In 2020, Roche entered into a number of new partnerships, including with Gilead, Regeneron and Atea, to develop, manufacture and distribute molecules that can potentially both treat and prevent COVID-19.
In October, Roche announced a partnership with Atea Pharmaceuticals to jointly develop the investigational compound AT-527. If approved, Atea will distribute AT-527 in the United States (US) and Roche will be responsible for global manufacturing and distribution outside the US. Atea’s compound has the potential to be the first oral antiviral to treat COVID-19 patients outside the hospital setting as well as in the hospital. Its anticipated formulation (pill) could allow for large-scale manufacturing and may help to facilitate access to a broad patient population.
In November, our partner Regeneron received FDA EUA for casirivimab and imdevimab, its investigational antiviral antibody combination, for the treatment of recently diagnosed patients with mild to moderate COVID-19 who are at high risk of progressing to severe COVID-19 and/or hospitalisation. The antibody cocktail is currently being studied in two phase I-III adaptive clinical trials for the treatment of COVID-19 and in a phase III trial for the prevention of the disease. As part of the global partnership with Regeneron, we are committing a significant amount of manufacturing capacity and are working to expand supply of this antibody combination beyond the US to as many people as possible.
In addition, we are exploring the potential of our investigational molecules and existing portfolio: For example, Roche has initiated three global phase III clinical trials investigating the safety and efficacy of Actemra/RoActemra in COVID-19 associated pneumonia (COVACTA, EMPACTA and REMDACTA). Following initial interactions with health authorities, Roche will continue to monitor the evolving clinical evidence for Actemra/RoActemra in this setting.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
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Maumar, off the top of your head, do you know how many new HALO shares will be printed if and when the note holders exercise their privileges at $77?
These will be in addition to the almost 10 million shares given to close out the previous note.
-Fritz
Was 95% institutionally owned. We can't be sure of that after this debacle.
I'm not happy but I'm not a seller, yet.
I don't understand your math. If HALO was trading at a 15 PE the share price would be in the $20's.
I think I've been pretty consistent in my complaints since this deal came to light:
$800 million in debt,
~10 million new shares printed and dumped on the market,
Enhanze deals few and far between,
Violation of Helen's assurances that no new financings were on the horizon.
This is not the clearly defined business model that caused institutions to buy over 90% of HALO and run it up to the mid $50's.
If you are convinced that we'll meet your prophecy of advancing into the high $70's your'll have to explain to me how that will be accomplished beyond pointing to past precedent which doesn't apply today.
Wrong. Im talking about the ~10 million shares (worth ~$40 million today) issued to the earlier debenture holders to buy them out of the deal.
Yes, the other shares you mention pertain to the new obligation and do have that favorable conversion price.
Go on pretending we just went into 800 million in debt by getting free money. The reality is the $40 million dollars worth of shares equates to 5%
cost of capital. Not as cheap now is it? And that doesn't include the actual interest rate.
The market has spoken and will continue to vote thumbs down until they come up with a clear partnership deal that will put the wheels back this thing.
The only reason this stock is not trading at triple zeroes is because of multiple reverse splits. Scam Scam Scam.
You neglected to mention the 10 million additional shares granted to the original convertible holders to entice them out of their position.
I'm not talking about the first round.
I think the answer to your question #4 is that the new CFO has Helen's ear and is mesmerizing her with flimflam "financial engineering" practices. I still don't know why Laurie left, but it was concerning to me at the time and even more so now that I've seen the new one's big ideas.
We'll see prices dip into the $30's now because management is totally off its game.
"...with buybacks is not dilutive."
C'mon, man, that is a stretch. Almost 10 million shares added now, plus millions more convertible shares will come online if/when the price hits ~$77. One can't ignore these just because there is a simultaneous buyback program in place.
The "expected" acquisition is only a supposition (and one which Helen talked down in the last call) while the phase three trials were entirely predictable. Thus the former is not reflected in the pps but the latter most certainly are.
And it must be said that the dilution is only a part of the story of this drop. The other part is that they violated their assurances that financings
were a thing of the past, AND, they took a clearly understandable and hugely successful business model and blew it up by creating vast uncertainty, muddying the waters about what the future holds. We know what the market feels about uncertainty. Confidence in the current management, and the wisdom of their future plans, formerly very high, is badly shaken. So, that's the story in total. In weeks and months to come, we'll languish hereabouts absent material news, and if the news involves a questionable and expensive acquisition, that will surely open a hole in the earth and sink HALO for a long time. This really sucks.
The drop was due to the dilution primarily, so the acquisition will be the next shoe to drop, IMHO.
I disagree. These are all baked in. The question is, what's next? If HALO drops a billion dollars on some acquisition, watch out below.
Good luck!
-Fritz
Not a peep from all the analysts who were taken in by Helen's lies about no new financing. They are hiding from embarrassment.
Could have just been the options expiry.