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And estimates will go up because of Phesgo, which I believe got approved almost 4 months early:
"We are excited that HER2-positive breast cancer patients in the U.S. will now have the option to receive this important therapy in a meaningfully shorter period of time," said Dr. Helen Torley, president and chief executive officer. "This subcutaneous delivery was shown to be preferred to IV administration by 85% of patients in the PHranceSCa study due to less time in the clinic and more comfortable treatment administration. Phesgo™ is the second product to receive FDA approval this year, and the first demonstrating the ability to combine two monoclonal antibodies, utilizing our ENHANZE® technology."
https://finance.yahoo.com/news/halozyme-announces-roche-receives-fda-165400171.html
$30 as fair value right now makes sense. Earnings avg. estimates are 0.76 (2020) and 1.44 (2021) and I think they will soon go up significantly.
TTO: Which patients would you recommend subcutaneous daratumumab for?
Landgren: Being that it is FDA approved as a subcutaneous drug, in my mind, that indicates should immediately be implemented and replace the IV drug. It gives us access to a good drug for more patients because it’s easier to give and we can give it anywhere. You don’t have the long infusion time in the beginning, which we used to have with the IV formulation.
https://www.targetedonc.com/view/ease-of-use-with-subcutaneous-daratumumab-supplants-the-intravenous-formulation-as-standard-of
https://ih.advfn.com/stock-market/NASDAQ/halozyme-therapeutics-HALO/stock-news/82702586/halozyme-to-receive-10-million-milestone-payment
"The milestone payment is associated with the first commercial sale in the European Union of Janssen's subcutaneous formulation of DARZALEX® (daratumumab) utilizing ENHANZE®, which was recently granted marketing authorization by the European Commission."
This is encouraging especially since the FDA acted a few weeks earlier than the European Commission. Perhaps Helen will start talking about revising revenue guidance on tomorrow's conference call.
Very happy to be wrong if the rally I've been expecting begins today instead of mid July.
The Goldman Sachs analyst asked the JNJ executive on the recent conference call several questions about Darzalex FasPro. Comments were very positive but the answers on the conversion rate from IV to SC were rather noncommittal. She said that it will depend on the market, new patients vs existing patients, frontline vs second and third line, etc. I believe she did say "we've already got some usage and the launch is going as well as we expected.", or words to that effect.
Lack of visibility to the launch is one of the reasons why we don't have a lot of buying or selling imo. I still think the stock will rally after JNJ's next earnings call.
https://www.cnbc.com/2020/06/08/lockdowns-prevented-nearly-5-million-us-coronavirus-cases-study-says.html
“During the early stages of an epidemic, a large proportion of the population remains susceptible to the virus, and if the spread of the virus is left uninhibited by policy or behavioral change, exponential growth continues until the fraction of the susceptible population declines meaningfully,” the researchers wrote."
It appears 1532 June 19 $22 calls were traded yesterday and 1184 June $21 calls on 6/2. Perhaps someone is accumulating shares buying in the money calls?
I think the FDA will move more quickly but the whole process will probably still take at least 3 or 4 years, though for Covid-related therapeutics it could go even faster.
In the meantime, perhaps the stock will get a little boost from this:
https://www.globenewswire.com/news-release/2020/06/04/2043780/0/en/Genmab-Announces-European-Marketing-Authorization-for-the-Subcutaneous-Formulation-of-DARZALEX-daratumumab-for-the-Treatment-of-Patients-with-Multiple-Myeloma.html
IMHO, this kind of news would not move the stock in a big way. It's taken an average of 6 years to develop an Enhanze formulation. They may be able to move faster now but within a year or so, perhaps much sooner, there will likely be better treatments and a vaccine for Covid-19.
What we need is accelerated revenue growth, more phase 3 trials and, ideally, more huge deals like the one with BMY.
"Early discussions" most likely means there is nothing concrete to report. On the other hand, Darzalex FasPro is real and for sale throughout US. SC Perjeta/Herceptin will be approved soon and I think the stock is consolidating, gearing up for a major breakout and begin a multiyear rally in the next 4/6 weeks. If I am wrong, it probably means the market knows something I don't and I will start thinking about reducing my position.
Some interesting information I had not heard about in this long interview with Dr. Mateos, who I think was involved with one of the trials. Just one doctor's opinion, and she may have a conflict of interest, but she is very positive on Darzalex FasPro.
ASCO, JNJ's and HALO's earnings calls will hopefully move the stock higher and higher.
https://www.onclive.com/podcasts/fda-approval-insights-subcutaneous-daratumumab-in-multiple-myeloma
All of the above, plus a new deal, 3 phase 3 trial starts, SC Perjeta/Herceptin approval by October, hopefully sooner, and we may see $40 by the end of the year. I think many investors (and analysts) still need to be reassured that this time (with Darzalex and perjeta/herceptin) it will be different.
Approval was expected and we went from $13.90 on March 18 to about $25 in the last couple of days. Some investors hedge after this type of move. Also, the stock price is close to analysts' consensus estimates:
"The current consensus among 7 TipRanks analysts is for a Moderate Buy rating of shares in Halozyme, with an average price target of $26.86.
The analysts price targets range from a high of $39 to a low of $13."
https://finance.yahoo.com/news/barclays-sticks-hold-rating-halozyme-071837426.html
Enthusiastic comments about Darzalex FASPRO on the next JNJ and GMAB earnings calls and a revised guidance from Halo in August may take us $30, perhaps higher, depending on how bullish the guidance is, imho.
It looks like there was a block trade of about 315K shares at 12:06PM ET that caused the PPS to drop. I guess a battle between bulls and bears is raging. We have analysts' PTs at $34, $35 and $39 but also as low as $23 (JP Morgan) and perhaps lower, I think.
Given the fact that Darzalex FASPRO is available starting from today, I was a little disappointed, and I think several analysts were too, that they did not revise their guidance. Hope I'm wrong and we get some upgrades anyway.
Interesting comments on Darzalex FASPRO from the May 6, 2020 GMAB earnings call:
Wimal Kapadia -- Sanford C. Bernstein & Co., LLC -- Analyst
Great. Thanks very much for taking my question. Wimal Kapadia from Bernstein. Just following on from Trung's question. I just want to get your thoughts on the subcu launch during the pandemic. Is it -- is the impact from COVID-19 negative given that it's harder to get new patient starts? Or would you argue that actually the ability to get patients out of the clinic, hospitals quicker will increase the launch trajectory? So I'm just trying to think about the impact in totality. Maybe near term, it's a delay, but longer term, for the rest of 2020, it actually may be beneficial. Just to get some thoughts will be great.
Jan G. J. van de Winkel -- President & Chief Executive Officer
Thanks, Wimal, for the question. I will start off with this answer, and then see whether Anthony Mancini can give further color.
Let me start off with the question on the launch. Janssen is, of course, doing a completely virtual launch. In this era, it's impossible to have salespeople on the floor, basically, for launching DARZALEX FASPRO. But we have already heard from bigger medical centers, Wimal, that they are training nurses right now in the United States. Actually, the nurses have been trained to actually visit patients at their homes and actually inject them at home with DARZALEX FASPRO. This is initiated by the major medical centers in the U.S. And that could actually be a very significant positive impact on the use of DARZALEX because, as Anthony Pagano has already said in his introduction remarks, these patients need to be treated.
I mean when you don't treat a multiple myeloma patient, Wimal, it doesn't end positively for the patient. I mean they really need to be treated with drugs like daratumumab. And I think by having available a very rapid three- to five-minute injection, this can potentially be even given at home to patients, is a huge advantage because one -- if one considers that these patients are definitely many times in the risk category or being immuno-compromised, they are elderly patients, because that is the population which gets multiple myeloma, Wimal, I think it is a huge advantage to potentially give it in a short time and at home.
And as I already said in my introductory remarks, the safety is just excellent of DARZALEX FASPRO. It seems to be better. Administration-related reactions are roughly 2 times [Phonetic] less basically than what they are with IV, so I think this could actually be a benefit in the end.
But let me ask Anthony Mancini to see whether he can add further color on the launch of DARZALEX FASPRO in this era with coronavirus and infections threatening us all. Anthony?
Anthony Mancini -- Executive Vice President & Chief Operating Officer
Thanks. Thanks, Jan, and thanks, Wimal, for the question. I think Jan covered it pretty thoroughly. I think we're really enthusiastic about the potential for DARZALEX FASPRO particularly in an environment where infusion centers are -- have limitations. So I think Jan covered the key point, which is relative to sitting through a several-hour infusion, being able to give a fixed-dose, three- to five-minute injection, we think, presents significant advantages in addition to the consistent efficacy that DARZALEX FASPRO has with the IV formulation. So I think those are the key advantages.
The couple of things that I would add are related to what Janssen has been able to do in terms of launch readiness and enabled practices across the U.S. to really flexibly learn about DARZALEX FASPRO. And whether they choose to do that through representatives, MSLs or nurse educators or whether they choose to do that through non-personal approaches, the team is ready. And the product, as Jan mentioned, will be available as early as next week.
And the other thing that Janssen has done is they've amended all company-sponsored clinical studies of daratumumab to allow patients to switch from the IV formulation to the subcutaneous formulation if there is a patient and physician desire to do so. And that will enable the team to collect really important safety data and patient preference data in these studies. So that's, I think, where I'll leave it, Jan.
....
I mean the second question was, of course, the conversion to the subcu formulation. What we understand is that Janssen believes that many patients will actually be switching to the subcu in time. To give actual numbers is very, very difficult, especially given the coronavirus era, Kennen, but I think that could actually accelerate the conversion rate to subcu DARZALEX. The pricing is roughly similar, as we have heard from Janssen. But I think the convenience and the potential even better safety of the subcu formulation can really, really help, especially in times like this, to really accelerate that conversion rate. But we prefer not to give you percentages here. So you have to do your own modeling, Kennen, and then -- and we will happily read that tomorrow.
I am especially looking forward to her explaining which indications Darzalex FASPRO has not been approved for and how prevalent they are.
A pretty significant benefit of SC Darzalex I had not read about is the following:
"because it is administered as a fixed dose from the first treatment, it reduces preparation time and chances of error by eliminating the need for dose calculations.”
https://www.businesswire.com/news/home/20200430005934/en/CHMP-Grants-Positive-Opinion-DARZALEX®?-daratumumab-Subcutaneous
Label in Europe may be a little broader than in US.
Morgan Stanley
Following CHMP recommendation, EMA likely to approve subcutaneous Darzalex in both frontline and R/R Multiple Myeloma: The Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), has issued a positive opinion for subcutaneous Darzalex for the treatment of Multiple Myeloma in both the frontline and relapsed/refractory setting. Approvals in the EU typically occur ~1/2 months after a positive CHMP recommendation. This decision is based on results from the PhIII COLUMBA and PhII PLEIADES studies. The recommendation for approval of the SubQ formulation includes a broad label, with all indications for which the IV drug is already approved. Further, we note the approval comes early. Original expectations for a regulatory response in the EU were mid-2020. We expect a response from FDA on potential approval in the U.S. by midyear. Overall, we see the recommendation of SubQ Darzalex with a broad label as a positive, and if approved, likely to drive growth in uptake in the near term.
If you are right, even just one new collaboration a year could add $100M in upfront and milestone payments. With operating expenses coming down and royalties going up, this would go straight to the bottom line.
We will see what kind of revenue/earnings estimates analysts come up with in the next couple of weeks and we may learn more on the next JNJ, GMAB earnings calls in July. I don't think the market expected SC Darzalex to be available for patients on May 11. If Roche moves just as quickly after the SC Perjeta/Herceptin approval expected in October, the 2021 High Revenue and Earnings estimates ($475M, $2.14) I see on Yahoo Finance may turn out to be conservative.
I'm hoping that trials haven't been delayed and we will still have 3 new phase 3 trial starts in 2020. It would give Halo leverage in potential buyout talks.
I hope so. But don't you think big pharma and biotechs have known about Enhanze for a long time at this point?
I thought so too, especially since I seem to remember Helen saying that it would not be available until perhaps 2021, or at least that royalties to Halo would not be significant until then.
From the Janssen press release:
"Based on its favorable profile, we are accelerating the development of DARZALEX FASPRO and evaluating its potential in multiple ongoing studies.”
I'm not clear what this means but apparently Darzalex Fasbro is not approved for all the indications granted for IV Darzalex . From Halozyme's press release:
""We are also pleased with the breadth of indications granted to DARZALEX FASPRO™, which includes the majority of the indications granted for the IV DARZALEX® formulation."
Press release from Janssen:
"DARZALEX FASPROTM will be available to patients and physicians as soon as the week of May 11, 2020."
https://johnsonandjohnson.gcs-web.com/static-files/65c8f0c9-6c40-4143-95e5-f65bb03bae9f
Press release from Genmab:
“The approval of the subcutaneous formulation of daratumumab, DARZALEX FASPRO, is a landmark event in the development of daratumumab. Not only is it now the first and only subcutaneous CD38 antibody approved for the treatment of multiple myeloma, the subcutaneous administration of DARZALEX FASPRO considerably reduces treatment burden, as the fixed-dose injection is administered in approximately three to five minutes, offering patients a more convenient treatment experience. As seen in the pivotal study supporting the approval, this reduction in infusion time from hours to minutes led to higher satisfaction levels for patients and in addition, infusion-related reactions were both mild and significantly reduced with this formulation of daratumumab. We are very much looking forward to the launch of DARZALEX FASPRO in the U.S. and the potential for positive impact it will have on the lives of the patients receiving the drug,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
https://ir.genmab.com/news-releases/news-release-details/genmab-announces-us-fda-approval-subcutaneous-formulation
Pretty subdued response to SC Darzalex approval, though only Halo had a press release and, as far as I can tell, less than an hour before closing. Of course, S&P and XBI being down almost 3% did not help.
I guess we will get a better sense of whether the market thinks the good news was priced in already in the next few weeks.
Yes! Very happy I was wrong about thinking it may happen in July.
FDA and EMA submissions were both in July 2019. If EMA approval will probably happen in 60 days, I'm assuming FDA's might come around the same time.
https://ir.genmab.com/news-releases/news-release-details/chmp-issues-positive-opinion-recommending-subcutaneous
FDA approval is then more likely to be in July as well, not May. I hope I'm wrong.
Not sure if this has been posted already.
"Total deaths in seven states that have been hard hit by the coronavirus pandemic are nearly 50 percent higher than normal for the five weeks from March 8 through April 11, according to new death statistics from the Centers for Disease Control and Prevention. That is 9,000 more deaths than were reported as of April 11 in official counts of deaths from the coronavirus."
https://www.nytimes.com/interactive/2020/04/28/us/coronavirus-death-toll-total.html?action=click&module=Spotlight&pgtype=Homepage
Thanks. I thought JNJ had already filed everywhere but still good news.
Could the chart be starting to trace a cup and handle formation? I have no idea. I'm just wondering if traders may be thinking the chart is looking good.
On second thought and after checking the IBB and XBI charts, I have to say that even though Halo has outperformed in the past few trading days, both IBB and XBI are near all time highs. The whole sector has had an amazing rally in the past 5 weeks, so maybe we need to curb our enthusiasm a little.
Still, we do have two significant catalysts in the next 6 months and halo's stock has not always been among the stronger biotechs.
I am certainly no expert on ETFs but the strength of the sector and forced buying is no doubt part of Halo's strong recent stock action. On the other hand, I don't see Halo as one of the top holdings in IBB or XBI and Halo's outperformance has been significant in the past 5 days.
I just don't know if this is the case, but if both potential buyers and Halo think royalties will get to at least $500M by 2027 and to $300 much sooner, a buyout price - let's say in the next 6-9 months - somewhere between $40 and $50 seems reasonable to me. According to Yahoo Finance, earnings estimates for 2021 are between 0.92 and 2.14. I would think they could be much higher as early as 2022 if analysts and Helen are right that 80% of patients/doctors will choose to use SC Darzalex, pretty much from the get-go.
https://finance.yahoo.com/quote/HALO/chart?p=HALO#eyJpbnRlcnZhbCI6NSwicGVyaW9kaWNpdHkiOjEsInRpbWVVbml0IjoibWludXRlIiwiY2FuZGxlV2lkdGgiOjIuOTYzNDQ2NDc1MTk1ODIyNSwidm9sdW1lVW5kZXJsYXkiOnRydWUsImFkaiI6dHJ1ZSwiY3Jvc3NoYWlyIjp0cnVlLCJjaGFydFR5cGUiOiJsaW5lIiwiZXh0ZW5kZWQiOmZhbHNlLCJtYXJrZXRTZXNzaW9ucyI6e30sImFnZ3JlZ2F0aW9uVHlwZSI6Im9obGMiLCJjaGFydFNjYWxlIjoicGVyY2VudCIsInBhbmVscyI6eyJjaGFydCI6eyJwZXJjZW50IjoxLCJkaXNwbGF5IjoiSEFMTyIsImNoYXJ0TmFtZSI6ImNoYXJ0IiwiaW5kZXgiOjAsInlBeGlzIjp7Im5hbWUiOiJjaGFydCIsInBvc2l0aW9uIjpudWxsfSwieWF4aXNMSFMiOltdLCJ5YXhpc1JIUyI6WyJjaGFydCIsInZvbCB1bmRyIiwi4oCMdm9sIHVuZHLigIwiXX19LCJzZXRTcGFuIjp7Im11bHRpcGxpZXIiOjUsImJhc2UiOiJkYXkiLCJwZXJpb2RpY2l0eSI6eyJpbnRlcnZhbCI6NSwicGVyaW9kIjoxLCJ0aW1lVW5pdCI6Im1pbnV0ZSJ9fSwibGluZVdpZHRoIjoyLCJzdHJpcGVkQmFja2dyb3VuZCI6dHJ1ZSwiZXZlbnRzIjp0cnVlLCJjb2xvciI6IiMwMDgxZjIiLCJzdHJpcGVkQmFja2dyb3VkIjp0cnVlLCJldmVudE1hcCI6eyJjb3Jwb3JhdGUiOnsiZGl2cyI6dHJ1ZSwic3BsaXRzIjp0cnVlfSwic2lnRGV2Ijp7fX0sImN1c3RvbVJhbmdlIjpudWxsLCJzeW1ib2xzIjpbeyJzeW1ib2wiOiJIQUxPIiwic3ltYm9sT2JqZWN0Ijp7InN5bWJvbCI6IkhBTE8iLCJxdW90ZVR5cGUiOiJFUVVJVFkiLCJleGNoYW5nZVRpbWVab25lIjoiQW1lcmljYS9OZXdfWW9yayJ9LCJwZXJpb2RpY2l0eSI6MSwiaW50ZXJ2YWwiOjUsInRpbWVVbml0IjoibWludXRlIiwic2V0U3BhbiI6eyJtdWx0aXBsaWVyIjo1LCJiYXNlIjoiZGF5IiwicGVyaW9kaWNpdHkiOnsiaW50ZXJ2YWwiOjUsInBlcmlvZCI6MSwidGltZVVuaXQiOiJtaW51dGUifX19LHsic3ltYm9sIjoiWEJJIiwic3ltYm9sT2JqZWN0Ijp7InN5bWJvbCI6IlhCSSJ9LCJwZXJpb2RpY2l0eSI6MSwiaW50ZXJ2YWwiOjUsInRpbWVVbml0IjoibWludXRlIiwic2V0U3BhbiI6eyJtdWx0aXBsaWVyIjo1LCJiYXNlIjoiZGF5IiwicGVyaW9kaWNpdHkiOnsiaW50ZXJ2YWwiOjUsInBlcmlvZCI6MSwidGltZVVuaXQiOiJtaW51dGUifX0sImlkIjoiWEJJIiwicGFyYW1ldGVycyI6eyJjb2xvciI6IiM3MmQzZmYiLCJ3aWR0aCI6MiwiaXNDb21wYXJpc29uIjp0cnVlLCJzaGFyZVlBeGlzIjp0cnVlLCJjaGFydE5hbWUiOiJjaGFydCIsInN5bWJvbE9iamVjdCI6eyJzeW1ib2wiOiJYQkkifSwicGFuZWwiOiJjaGFydCIsImZpbGxHYXBzIjpmYWxzZSwiYWN0aW9uIjoiYWRkLXNlcmllcyIsInN5bWJvbCI6IlhCSSIsImdhcERpc3BsYXlTdHlsZSI6InRyYW5zcGFyZW50IiwibmFtZSI6IlhCSSIsIm92ZXJDaGFydCI6dHJ1ZSwidXNlQ2hhcnRMZWdlbmQiOnRydWUsImhlaWdodFBlcmNlbnRhZ2UiOjAuNywib3BhY2l0eSI6MSwiaGlnaGxpZ2h0YWJsZSI6dHJ1ZSwidHlwZSI6ImxpbmUiLCJzdHlsZSI6InN0eF9saW5lX2NoYXJ0IiwiaGlnaGxpZ2h0IjpmYWxzZX19LHsic3ltYm9sIjoiSUJCIiwic3ltYm9sT2JqZWN0Ijp7InN5bWJvbCI6IklCQiJ9LCJwZXJpb2RpY2l0eSI6MSwiaW50ZXJ2YWwiOjUsInRpbWVVbml0IjoibWludXRlIiwic2V0U3BhbiI6eyJtdWx0aXBsaWVyIjo1LCJiYXNlIjoiZGF5IiwicGVyaW9kaWNpdHkiOnsiaW50ZXJ2YWwiOjUsInBlcmlvZCI6MSwidGltZVVuaXQiOiJtaW51dGUifX0sImlkIjoiSUJCIiwicGFyYW1ldGVycyI6eyJjb2xvciI6IiNhZDZlZmYiLCJ3aWR0aCI6MiwiaXNDb21wYXJpc29uIjp0cnVlLCJzaGFyZVlBeGlzIjp0cnVlLCJjaGFydE5hbWUiOiJjaGFydCIsInN5bWJvbE9iamVjdCI6eyJzeW1ib2wiOiJJQkIifSwicGFuZWwiOiJjaGFydCIsImZpbGxHYXBzIjpmYWxzZSwiYWN0aW9uIjoiYWRkLXNlcmllcyIsInN5bWJvbCI6IklCQiIsImdhcERpc3BsYXlTdHlsZSI6InRyYW5zcGFyZW50IiwibmFtZSI6IklCQiIsIm92ZXJDaGFydCI6dHJ1ZSwidXNlQ2hhcnRMZWdlbmQiOnRydWUsImhlaWdodFBlcmNlbnRhZ2UiOjAuNywib3BhY2l0eSI6MSwiaGlnaGxpZ2h0YWJsZSI6dHJ1ZSwidHlwZSI6ImxpbmUiLCJzdHlsZSI6InN0eF9saW5lX2NoYXJ0IiwiaGlnaGxpZ2h0IjpmYWxzZX19XSwic3R1ZGllcyI6eyJ2b2wgdW5kciI6eyJ0eXBlIjoidm9sIHVuZHIiLCJpbnB1dHMiOnsiaWQiOiJ2b2wgdW5kciIsImRpc3BsYXkiOiJ2b2wgdW5kciJ9LCJvdXRwdXRzIjp7IlVwIFZvbHVtZSI6IiMwMGIwNjEiLCJEb3duIFZvbHVtZSI6IiNGRjMzM0EifSwicGFuZWwiOiJjaGFydCIsInBhcmFtZXRlcnMiOnsid2lkdGhGYWN0b3IiOjAuNDUsImNoYXJ0TmFtZSI6ImNoYXJ0IiwicGFuZWxOYW1lIjoiY2hhcnQifX0sIuKAjHZvbCB1bmRy4oCMIjp7InR5cGUiOiJ2b2wgdW5kciIsImlucHV0cyI6eyJpZCI6IuKAjHZvbCB1bmRy4oCMIiwiZGlzcGxheSI6IuKAjHZvbCB1bmRy4oCMIn0sIm91dHB1dHMiOnsiVXAgVm9sdW1lIjoiIzAwYjA2MSIsIkRvd24gVm9sdW1lIjoiI2ZmMzMzYSJ9LCJwYW5lbCI6ImNoYXJ0IiwicGFyYW1ldGVycyI6eyJ3aWR0aEZhY3RvciI6MC40NSwiY2hhcnROYW1lIjoiY2hhcnQiLCJwYW5lbE5hbWUiOiJjaGFydCJ9fX19
So, if they've found a buyer, what will the buyout price be? I guess it will depend on how confident both Halo and the buyer are in Helen's projections. I kind of doubt they are realistic but maybe I'm wrong.
In the meantime, stock is stronger than the market and XBI again today, for now. It sure feels like we'll get some type of good news next week.
I still don't want to jinx it...
Eventually, JNJ and Roche bidding against each other would be the best and perhaps most likely scenario.
This move of course could be due to a lot of other reasons. The whole biotech sector has been very strong and perhaps another huge deal is in the works, more doctors are forced to use SC formulations because hospitals are overwhelmed, etc., but my best guess is still that SC Darzalex is about to be approved.
MRUS: very high volume yesterday (1.35M) and up 8% today for now.
Any news that you know of? I've also had a small position for a long time.
I don't want jinx it but stock is even stronger today. I wonder if they will reveal something at the annual meeting on April 30. Something good seems to be brewing.
That may help some and I also hope Halo bought a ton of shares when the stock crashed.
But I think royalties will be flat at best, some trials have probably been delayed, and it's really all about SC Darzalex at this point. SC Herceptin/Perjeta in October, so in the not too distant future, is also something investors are probably looking forward to. I'm assuming these are the main reasons Artisan bought a lot of shares recently. Their timing appears to have been good and hopefully other institutions are buying too.
Stock is green right now with SPY and XBI down more than 2%.
Best case scenario is that the pdufa date for SC Darzalex is May 12. It feels like the stock may break out just around then.
A silver lining to Covid: it's giving the pharmaceutical industry an opportunity to improve its reputation and there seem to be more supporters than haters right now. From the NYT:
"Given the stakes involved, it seems perverse not to root for Gilead’s success. Just as there are no atheists in foxholes, there should be no big-pharma haters in pandemics. Last year, Elizabeth Warren wrote that “giant drug companies only care about one thing: raking in profits on the backs of patients.” I wonder if the Massachusetts senator would have the nerve to say that to Dr. Brainard and every other private-sector scientist laboring to find cures under the intense strain of this global emergency.
It’s also worth asking what this story says about the notion that the pandemic somehow proves Bernie Sanders right. Medicare For All, achieved through wrenching changes at ruinous expense, might provide “coverage” for every American, including the millions of newly unemployed.
But that’s of little help without effective diagnostic tests, therapies and vaccines, which typically emerge from profit-seeking companies operating in fiercely competitive and well-regulated marketplaces. Whatever the fate of remdesivir or any other drug, one lesson from this pandemic is how dependent we are for our survival on an innovative and robust pharmaceutical industry. Maybe we should do more as a country to cultivate it than tear it down."
https://www.nytimes.com/2020/04/17/opinion/remdesivir-coronavirus.html?action=click&module=Opinion&pgtype=Homepage
FDA approves SGEN's Tucatinib four months early.
https://finance.yahoo.com/news/seattle-genetics-announces-u-fda-182700831.html