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Why has the pace been so slow in your opinion?
Well, um, yeah. There are literally hundreds of drugs that would be compatible with Enhanz and yet, to say the least, the deals have been few and far between. Are you not even a little concerned about this?
The real question is how the company is going to grow with their apparent inability to foster new partnerships. Those announcements you refer to do not address that concern.
Dew, is Prevnar a once and done vaccine or is it recommended yearly?
Thanks,
-Fritz
I'm always happy to hear opposing opinions based on facts. If you can rebut my detailed post of a few days ago, please share your fact based opinions. Otherwise, personal attacks are not tolerated here.
I confess I'm not aware of the life sciences funds you mentioned.
You are probably right about Blackrock.
I would have a hard time thinking the institutional holders are at all content, but their discontent can take many forms and, as with all of us, can be subject to a certain inertia. No signs of them voting with their feet, at least not yet, so, all things are possible.
I'm not at all certain of this, but I believe there must be certain SEC filings perfected before a heretofore non-activist large shareholder can begin to make an insurgent move. Of course, there may be other, informal conversations with board members to get them to do one's bidding outside the confines of a formal push to gain seats on the BOD.
One can hope, but I see no signs of any shareholder activism brewing.
What leads you to believe that a change is in the wind?
In my opinion it all comes down to bad leadership. There is no other explanation.
Enhanz is a 1st in class product and has, until recently, held the field all to itself.
It should be a cash generating monster, but it has never hit it's full stride under Helen's tenure.
Since Helen's arrival there have been some few key deals and then we have since clearly stalled, despite the clear advantages and superiority of the product she is tasked with selling.
Other than that, she spent the better part of a $1 Billion on share buybacks, stripping the company of
important cash resources.
She bought an under performing asset in Antares.
She admitted in the last investor day that there are no other asset purchases pending, has no idea where the next one will come from, and she doesn't have the cash for any new acquisition anyway. Hence, more share buybacks.
And while I'm ranting, old time investors like me should recall she long ago opened up a fully staffed office in the Bay Area, where she resides, so that she needn't spend her precious time commuting to San Diego where everybody else works. (I'm sure the useless PR/IR department is glad the boss isn't there to watch them while the day away.) I have no idea how much this satellite office costs the company but it's the Bay Area, it's not Cleveland, so there it is.)
Let's not forget that Helen inherited Enhanz when she came on board.
Her only contribution was to shut down the cancer and diabetes pursuits, which were no brainers by the time she arrived.
Besides that, I'm hard pressed to see what value she brings.
Some peope are natural deal makers, some are not able to see beyond their stock options.
Helen is not a deal maker.
We need new leadership and new creative vision.
Interesting. The usual HALO partnership deal is not at all tied to the pps of one or the other partner. It's a straight bargain of licensing HALO's Enhanz technology in exchange for an upfront payment and 4% royalties on the sales of the combined product.
What type of deal are you contemplating in your first paragraph?
All of that is logical and yet the deals are not forthcoming, OJ. Why do you think this is?
Subcutaneous Nivolumab (nivolumab and hyaluronidase) Shows Noninferiority Compared to Intravenous Opdivo (nivolumab) in Advanced or Metastatic Clear Cell Renal Cell Carcinoma in CheckMate -67T Trial
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January 27 2024 - 10:00AM
Business Wire
https://ih.advfn.com/stock-market/NYSE/bristol-myers-squibb-BMY/stock-news/93152294/subcutaneous-nivolumab-nivolumab-and-hyaluronidase
CheckMate -67T is the first Phase 3 trial of the subcutaneous formulation of Opdivo to evaluate and demonstrate noninferior pharmacokinetics, efficacy and safety vs. its intravenous formulation
Subcutaneous nivolumab demonstrated noninferior pharmacokinetics (co-primary endpoints) and objective response rate (key powered secondary endpoint) compared to intravenous Opdivo
Results from the Phase 3 CheckMate -67T trial will be presented in a late-breaking oral presentation at ASCO GU 2024 in the first ever disclosure for subcutaneous formulation of Opdivo
Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy, demonstrating noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo. In addition, subcutaneous nivolumab displayed noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo. These results will be featured in a late-breaking oral presentation (Abstract #LBA360) at the American Society of Clinical Oncology (ASCO) 2024 Genitourinary Cancers Symposium from January 25-27, 2024.
“The data from CheckMate -67T with the subcutaneous formulation of nivolumab co-formulated with recombinant human hyaluronidase represent a groundbreaking advancement in oncology research for physicians and our patients,” said Saby George, M.D., F.A.C.P., professor of Oncology and Medicine, director of Network Clinical Trials, Department of Medicine, Roswell Park Comprehensive Cancer Center. “Having the option to administer immunotherapy subcutaneously could undoubtedly reduce the treatment burden that patients diagnosed with cancer currently face, as well as help maximize efficiencies within healthcare systems. As it stands, intravenous immunotherapy infusion can take precious time, which we know is an important commodity for patients and the doctors who treat them. That’s why these results indicating noninferiority with subcutaneous nivolumab have the potential to be practice-changing and to improve patients’ treatment experience with one injection that can be given in under five minutes and, in some cases, outside of the infusion center.”
In the CheckMate -67T trial investigating subcutaneous nivolumab (n=248) vs. IV Opdivo (n=247) in patients with advanced of metastatic ccRCC:
Cavgd28: Noninferiority of subcutaneous nivolumab to IV Opdivo was shown for the time-averaged serum concentration over the first 28 days, with a geometric mean ratio of 2.098 (90% Confidence Interval [CI]: 2.001 - 2.200).
Cminss: Noninferiority of subcutaneous nivolumab to IV Opdivo was shown for the minimum serum concentration at steady state, with a geometric mean ratio of 1.774 (90% CI: 1.633 - 1.927).
ORR: Noninferiority was also seen in the key powered secondary endpoint of ORR by BICR, with subcutaneous nivolumab demonstrating an ORR of 24.2% vs. 18.2% with IV Opdivo (Relative Risk Ratio [RR] 1.33; 95% CI: 0.94 to 1.87).
PFS: Median PFS by BICR with subcutaneous nivolumab was 7.23 months and 5.65 months with IV Opdivo.
Safety: The safety profile of subcutaneous nivolumab was consistent with the IV formulation. Incidence of local injection site reactions with subcutaneous nivolumab was 8.1%. Additionally, reactions were low grade and transient. Among patients treated with subcutaneous nivolumab (n=247), grade 3-4 adverse events (AEs) occurred in 35.2% of patients vs. 40.8% of patients treated with IV Opdivo (n=245). Treatment-related AEs occurred in 9.7% vs. 14.7% of patients, serious AEs in 21.1% vs. 22.9% of patients and treatment-related serious AEs in 6.5% of patients for both the subcutaneous and IV formulations.
“These results from the CheckMate -67T trial build on our deep scientific expertise in the use of immunotherapy in solid tumor oncology and our commitment to finding ways to help improve quality of life for patients,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. “We are thrilled to present this research for the first time evaluating subcutaneous nivolumab, demonstrating noninferiority compared to intravenous Opdivo and supporting subcutaneous nivolumab as a potential new option to improve healthcare efficiency. Convenience is an important benefit of subcutaneous immunotherapy and we are excited about the potential for this treatment to reduce patient burden and provide greater flexibility to patients and health care providers. We look forward to discussing next steps for subcutaneous nivolumab across multiple tumor types with health authorities.”
Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -67T clinical trial.
About CheckMate -67T
CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. intravenous Opdivo. Objective response rate (ORR) is a key secondary endpoint.
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Clear cell renal carcinoma (ccRCC) is the most common form of RCC, affecting about 7 out of 10 people with RCC. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 14% and five-year disease-free survival (DFS) rates for those with localized disease that can be resected are just over 50%.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.
OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
IMPORTANT SAFETY INFORMATION
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticost
How long are you planning to stick with it? I've completely lost confidence in the current management. Of course they might come up with a big upside surprise but I've wasted too much time waiting for that to happen and the longer I wait, the less likely it will happen in my estimation.
It was always the biggest piece of my portfolio, but that is no longer the case. I've been lightening up and will continue to unwind in a gradual way, absent the usual caveats. What is your position?
Note that the September numbers showed them selling an almost equal number of shares, so this is a recoupment of those shares, likely at a lower price.
IR is a joke. Their website showing active partnership pipeline often so out of date as to be materially misleading.
This stems from poor leadership and Helen owns all of the failures.
OJ, I'm comparing the recent totals in the filing with the last reported totals on the NASDAQ website
https://www.nasdaq.com/market-activity/stocks/halo/institutional-holdings
Chartwise, deathcross is looming. More fun times ahead.
Blackrock added over 500k shares.
https://www.sec.gov/Archives/edgar/data/1159036/000108636424001360/us40637h1095_012324.txt
AFTER this week's call, analysts are all over the map from $40 to $71. Geez.
Benchmark reiterates $50 PT and BUY rating.
JMP raises PT from $66-$72 maintains outperform rating
Thanks for the correction on Goldman's participation. I misheard her ID but did hear the question and Nicole's answer.
I agree that we are, to a large degree, beholden to the interest rate background. It's not a coincidence that HALO's peak pps was at the time when the 10 year bonds were at 2%.
The presentation was good in so far as the IP questions were finally met definitively by Mr. Snyder, Esq. who is clearly an expert in his field and speaks with precision and authority, IMHO.
Everything else was the usual happy talk. The street is now calling them out on that and leadership must be held accountable. There is no place to hide for Helen. We need a new executive team who has a vision for the future.
My post from last Friday, January 12th:
H. C. Wainwright cuts PT from $61-$48, maintains buy rating
The Goldman analyst did not pose a question in the call, FWIW.
Goldman cuts PT from $45-$40, maintains neutral weight.
Interesting point about the earnings projections. I'd rather they under promise and over deliver, but they have not shown a consistency in that regard.
Regarding my points #1-3, you say you are not worried about #1 (diversifying the product line via M&A) but then you rightly talk about Merck not wanting to pay the royalties and thus have gone off on their own. Doesn't that undercut your argument that Halozyme is safe being a one-trick Enhanz-dependent pony? If Merck can walk away, others might also and indeed seem to be doing so more often than not.
Yes, M&A does have some cyclicality to it, but Helen has taken HALO out of the M&A game because it has no cash on hand to be a buyer.
Thus, all we get is more talk of share buybacks "returning value to shareholders" as the pps slides back towards the $20's.
Your confusion regarding the lagging pps is easily clarified if you look beyond Helen's constant happy talk and see the questions that were NOT answered.
Yes, I agree that the patent guy Snyder was excellent and the info provided helped clear up this important nagging issue to a large degree.
The remaining questions weighing on the pps are:
1.) how is Halozyme, Inc. going to grow outside of the Enhanz franchise, particularly when HALO has spent the better part of $1 billion on share buybacks rather than M&A opportunities and ready cash is now, as a consequence, very limited?
2.) why are major partners making subcu deals with other competitors and choosing not to do business with Halozyme?
3.) Why are collaborative deals with new partners not forthcoming, or if they are, why has the pace been so glacial?
What are your thoughts on these topics?
With new leadership, yes.
re: collab partners signing deals with new competitors: nothing but boilerplate language from Helen.
re: new deals promised and not delivered: wait til next month.
re: use of cash flow: same old same old (buybacks are still in the mix - sigh).
Helen just said will refuse to address any questions about the pending pipeline deals in today's call.
Thanks, good find. Did the analyst have any comments on the two recent subcu failures (pemphigus and thrombocytopenia)?
If Helen thinks she can still blow smoke and bedazzle the analysts, this call could really tank the SP next week.
Her rosey chatter is not going to cut it anymore. If she fails to deliver concrete deals as promised (at a minimum!)
we are in for a major setback. Tighten your seatbelts.
SAN DIEGO, Jan. 12, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that it will host an Investor Business Forum and Long-Term Outlook Call on Wednesday, January 17, 2024 at 5:30 a.m. PT / 8:30 a.m. ET.
On the call, Dr. Helen Torley, President and Chief Executive Officer will be joined by Mark Snyder, Chief Legal Officer and Nicole LaBrosse, Chief Financial Officer to present detailed guidance around the patent dynamics that are expected to drive revenue durability of Halozyme's ENHANZE® drug delivery technology. The company will also provide 2024 financial guidance as well as long term financial outlook.
A webcast of the live call can be accessed via link here: https://ow.ly/Zi0050QqaCF. The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and presentation materials related to the call, please visit Halozyme.com.
The conference call may also be accessed with the dial-in information below:
Participant Toll-Free Number: 800-225-9448
Participant Direct/International Number: 203-518-9708
Conference ID: HALO0117
As a strategic fit it makes theoretical sense, but as an active rumor it has no traction, hence the current PPS.
This so-called "rumor" is a great big steaming pile of moose turd pie.