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We are stuck in this rut of underperformance and instead are given financial card tricks to keep us distracted instead of real meat on the bone momentum. Helen came aboard at a similar point in the company's development and re-focused the strategic plan with good results. Kudos for that, but I've come to believe another CEO is now necessary to move us forward. She's had ample time to demonstrate what she can do. She was good for a time but it's time to get some fresh blood. Glad to see Elaine gone, but this is only a start. All in my humble opinion.
I'd like to see new leadership. Hopefully the BOD has enough independence from Helen to make a good assessment. That is never something to be assumed, though, in today's corporate governance milieu.
The other thing that stands out about her departure is that it happened just 2 weeks before the Q and the conference call. The timing is a little odd there, but again, just reading the tea leaves.
I disagree only to the extent that the wording is not a lie if she tenders her resignation, albeit under duress. That's the leverage over every professional in such cases. Resign and walk away with your dignity and reputation intact, or insist on getting fired publicly. Most take option one.
What do you think? It's definitely an unexpected and unusual turn of events, or so it seems to me.
She walked in the door less than 24 months ago (can't remember exactly). She was compensated generously with options, bonuses(!!!) and salary, and I don't see any announcement of her new position anywhere.
Her furious spinning of wheels and financial shell games gutted the share price. I think it's likely that she was asked to leave, but I'm speculating based on my sour assessment of her time here.
I would not be shocked it the BOD also invites Helen to pursue new opportunities in the coming months.
It does feel like a sector reversal.
Blackrock reports 13.8% stake. I'd wager that they paid a lot less than our CFO has for their shares.
I think this latest pullback is all just broad market weakness in the Biotech space so in that sense I'm not really stunned. We were here just a few short weeks ago. Once biotech comes back into favor we'll show some life but I've no idea when that will happen. In the meantime, we should hold the line hereabouts, which is where the bleeding stopped the last time.
As for the buyback plan, I have no confidence in the CFO's idea nor in her execution, so I'd not be surprised that she pulled the trigger at $41. She may have been the buyer who got to $41 in the first place. LMAO!
As usual, Helen left many questions unanswered and succeded in muddying the waters. I'm betting that the patents are issued, because she is giving extremely specific expiry dates. Patents are easier to obtain even on a theoretical basis, because the concept doesn't have to be approved for use by other regulatory bodies, e.g. FDA, with different jurisdictions.
As for the requirement for new trials, my gut is that there will be some such requirement but it may be streamlined, since the original product has a demonstrably safe track record. This is not more than a guess though.
What do you think about the "new" product and the IP extension? I didn't get to listen to Helen on that topic today just yet.
Is it a done deal, i.e. have the patents been issued already or are they saying that it's in the works?
Anticipated 2022 Key Events:
Projected growth of approximately 50% in the Company's high-margin, recurring revenue stream from royalties to approximately $300 million driven by continued uptake of wave 2 launch products, subcutaneous DARZALEX® (daratumumab) and Phesgo® (pertuzumab, trastuzumab and hyaluronidase) utilizing ENHANZE® technology;
At least five new Phase 2/3 starts for existing ENHANZE® programs;
At least four new products utilizing ENHANZE® entering Phase 1 development by the Company's collaboration partners resulting in at least 20 products in development by end of 2022, compared to 16 at the end of 2021;
Data from ENHANZE® collaboration partner argenx SE for Phase 3 study of efgartigimod SC utilizing ENHANZE® technology in myasthenia gravis expected in the first half of 2022;
Investments to further drive revenue growth and extend revenue durability, including:
New, higher yield ENHANZE® API;
New rHuPH20, with extended room temperature stability, and with patent protection to 2032 in Europe and 2034 in the US;
At least one new global collaboration and license agreement for ENHANZE®, which is included in Company revenue guidance;
Up to $250 million in share repurchases, inclusive of $150 million accelerated share repurchase announced in December 2021, as part of the $750 million three-year share repurchase plan authorized by Halozyme's board of directors in December 2021 demonstrating the Company's continued commitment to a balanced capital allocation strategy.
If I read it correctly the PR says there is another deal completed but not yet identified and it is already included in the income estimates for 2022.
HALO's original 6/2021 PR on the ViiV partnership:
ViiV Healthcare and Halozyme enter global collaboration and license agreement for ENHANZE® drug delivery technology to enable development of "ultra-long-acting" medicines for HIV
06/22/2021
Halozyme's drug delivery technology provides the opportunity to administer large volume subcutaneous injections that may enable dosing intervals of every three months and up to six months or longer for ViiV's pipeline of HIV medicines
LONDON and SAN DIEGO, June 22, 2021 /PRNewswire/ -- ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, and Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced a global collaboration and license agreement that gives exclusive access to Halozyme's ENHANZE® drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV.
Under the terms of the agreement, ViiV Healthcare will make an upfront payment of $40 million to Halozyme for the exclusive license to four HIV small and large molecule targets and is obligated to make potential future payments of up to $175 million in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialised medicines using the technology.
The PH20 enzyme breaks down a substance called hyaluronan (HA) that is found in the body's subcutaneous space (under the skin) that acts as a barrier to the flow of fluid. By breaking down HA locally at the injection site and temporarily removing that barrier, large amounts of fluid can be injected into the subcutaneous space and dispersed. This facilitates the rapid delivery of large volume fluids by subcutaneous injection, potentially reducing the treatment burden of injectable drugs and providing optimised treatment options to patients. The HA is restored under the skin via normal processes within 24-48 hours.
Halozyme's technology provides ViiV Healthcare with more opportunities to develop ultra-long acting medicines (dosing intervals of three months or longer) with its long-acting portfolio and pipeline products. Plans are underway to initiate the first experiments with the technology by the end of 2021 for investigational, long-acting cabotegravir for prevention of HIV, which is currently administered every two months.
"Many people living with HIV and those vulnerable to HIV tell us that for a variety of reasons, taking medicine every day is a challenge, and we have listened to them," said Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare. "We believe long-acting medicines are the future of HIV therapies and will help address these unmet needs. Our collaboration with Halozyme will keep us at the forefront of developing additional, innovative new options for HIV treatment and prevention as we work towards reducing the burden of HIV treatment."
"We are excited to partner with ViiV Healthcare to create new delivery options for innovative medicines for HIV," said Helen Torley, M.B. Ch. B., M.R.C.P., president and chief executive officer, Halozyme. "This collaboration demonstrates the potential value of our technology to facilitate rapid, large volume subcutaneous injections of not only more traditional medicines but also long-acting injectables, including small molecules, which in turn may further extend dosing intervals for people taking medicines for the treatment and prevention of HIV."
The license gives ViiV exclusive use of Halozyme's proprietary rHuPH20 technology for four, specific HIV medicine targets that will expand opportunities for development of nearly all of ViiV's pipeline assets. These assets are integrase inhibitors, reverse transcriptase inhibitors limited to nucleoside reverse transcriptase inhibitors (NRTI) and nucleoside reverse transcriptase translocation inhibitors (NRTTIs), capsid inhibitors and broadly neutralising monoclonal antibodies (bNAbs), that bind to the gp120 CD4 binding site.
Halozyme has licensed its technology to 11 pharmaceutical and biotechnology companies, for potential use in oncology, autoimmune disease, rare disease and infectious disease with products currently approved in oncology and immune deficiency indications. In addition, Halozyme currently has a Cooperative Research and Development Agreement with the National Institute of Allergy and Infectious Diseases' Vaccine Research Center in the US, which includes a bNAb, N6LS, that ViiV Healthcare licensed from the National Institutes of Health in 2019.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially validated solution has touched more than 500,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics and ViiV Healthcare. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/en-gb/about-us/.
ViiV anti-HIV drug approved by FDA. I'm not sure if this is one of the targets they named in the recent deal with HALO.
https://www.prnewswire.com/news-releases/fda-approves-first-injectable-treatment-for-hiv-pre-exposure-prevention-301448538.html
No biotech and no M&A experience. They are clearly pulling in their horns with regard to buying another platform. This was made pretty evident by the use of the cash hoard to finance the second round of stock buy-backs just announced, and now confirmed by this new hire, IMHO.
I'm ok with that, as long as new deals keep coming and at a faster pace. I was worried that Helen would go off and overpay for some new venture, but that seems off the table right now. Stick to your knitting. This company hit $55 when the narrative was simple, i.e. that HALO was a cash generator.
Straightening out the IP worries and and removing the fear of HALO buying a new unknown technology should get us back on track.
And also maybe he can help Helen answer these persistent questions more clearly when they are put to her.
The new guy has intellectual property and licensing experience but no biotech or M&A experience, so it's hard to say. Since the issue of patent rolloffs is a constant refrain, maybe he can bring more expertise in that arena and help negotiate better deals going forward.
SAN DIEGO, Dec. 13, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Mark Snyder has been appointed senior vice president, general counsel, chief compliance officer and corporate secretary, effective January 3, 2022. Mr. Snyder will succeed Masaru Matsuda, who is stepping down to pursue another opportunity.
Mr. Snyder brings almost thirty years of legal and business experience to Halozyme. Over his career he has led and played key roles in a broad range of intellectual property, licensing, regulatory, anti-trust and litigation matters. Most recently Mr. Snyder served as senior vice president, deputy general counsel, litigation for Qualcomm Incorporated, a large, public, multinational wireless technology company with more than 40,000 employees. In that role Mr. Snyder led litigation strategy for hundreds of cases worldwide, winning key licensing, antitrust, intellectual property and business-related cases. In addition, Mr. Snyder managed Qualcomm's antitrust, legal operations and intellectual property advocacy teams. Prior to working at Qualcomm, Mr. Snyder served in leadership roles at several companies leading legal teams that included overseeing IP strategy development and prosecution. Mr. Snyder received his J.D. from Boston College Law School and M.B.A from Boston College Carroll School of Management. He also holds a B.S. in chemical engineering from the University of Rochester.
"I am delighted to welcome Mark, an accomplished legal and business leader, to our leadership team," said Dr. Helen Torley, president and chief executive officer. "We look forward to Mark's contributions as we benefit from his deep expertise and insights, as we grow the company with the goal of delivering additional value to shareholders. On behalf of the Board, I want to thank Mas for his contributions to Halozyme and wish him all the best in his future endeavors."
"I am pleased to join the outstanding leadership team at Halozyme at such an exciting time in the growth of the company. I look forward to leading the legal team to support that growth," said Mark Snyder.
Is efga decision due today?
XBI yes, but HALO might be another story.
Personally I wouldn't think that the General Counsel would leave "for other opportunities" if something good was in the works.
I take this as a sign that we are still stagnating in regards to any significant deals for the foreseeable future. I hope that I am wrong.
Agree on all points. I'd add that this company needs a fundamental change in leadership. Right now it appears that the leader is the CFO and she's out of ideas.
I wish it was in the 70's now and I'd be a happy man.
But the chart shows exactly what the broader market thinks of these financial engineering moves. It's undeniable that the downhill slide started exactly when the first convertible refi was announced and I expect no substantial change with this new buyback plan.
It shows the company has no forward game plan and no strategic vision. If the buybacks were in conjunction with a broader comprehensive approach I'd be a little more neutral about them.
A steady string of partnerships, followed by an announcement of a dividend, that would be the key.
Ask yourself, what if they find a new technology in a small company that they want to buy and suddenly see they are short of cash to make it happen. They'll issue MORE shares again in exchange for cash. At this time, under these circumstances, it's just plain stupid to spend another half billion dollars on this nowhere buyback plan. All my humble opinion of course.
Keep to the facts and opinions and you'll be ok. The minute you make a personal attack the post gets taken down. Simple.
Agreed on both points, but with caveats.
Well over 90% of the OS is held by institutions and thus the float is small and prone to exaggerated moves, especially to the downside when selling is sometimes forced by margin calls or stop limits. (Buying is rarely forced, but in an index it would be to a degree.)
Rebalancing has had an effect from time to time, but not so much here since in a rebalance scenario selliing would normally be provoked by profit taking when the position in a portfolio gets over-sized and needs trimming. Not the case here obviously.
I do think and hope it was a pre-arranged deal with an appropriately cheap pps. We'll likely find out at the next conference call.
A very unimpressive response to the big announcement. No surprise there. CFO ain't fooling anybody except Helen and the BOD.
Interesting, thanks. Do you think it was wise to announce in advance? Seems like it just made the buybacks more expensive. Hopefully the price had already been established before the announcement.
@ ~$33 pershare this would be a repurchase of ~7 million shares. There are only a handful of institutions that hold enough shares to enter into such a transaction.
https://www.nasdaq.com/market-activity/stocks/halo/institutional-holdings
You may be right but the plain language interpretation of the PR sounds like they are making a deal to buy from one seller.
The Company plans to enter into an accelerated share repurchase (ASR) program transaction with a financial institution in the coming week, subject to market conditions.
I wonder who the "institution" is that is the seller.
If Helen soon inks a couple of big partnerships then we'll be fine. If this
financial shell game is all they have in the tool box, then the stock price will continue the current ugly trajectory.
Ya gotta laugh....
The text of the PR:
HALOZYME ANNOUNCES $750 MILLION THREE-YEAR SHARE REPURCHASE PROGRAM
12/09/2021
- Company Plans to Purchase up to $250 Million Worth of Shares by the End of 2022 Starting with Entering into a $150 Million Accelerated Share Repurchase Program Transaction in the Coming Week -
- New Share Repurchase Authorization Follows Recent Completion of Three-year $550 Million Share Buyback -
SAN DIEGO, Dec. 9, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that its Board of Directors has approved a new share repurchase program effective immediately, which authorizes the Company to purchase up to $750 million of the Company's outstanding common stock over the next three years. The Company plans to enter into an accelerated share repurchase (ASR) program transaction with a financial institution in the coming week, subject to market conditions. The Company plans to purchase up to $250 million worth of shares by the end of 2022, including the $150 million ASR, pending market conditions and other factors.
"Our second share repurchase authorization demonstrates Halozyme's commitment to a balanced capital allocation strategy that includes investing in our operations, capital return and potential M&A," said Dr. Helen Torley, president and chief executive officer. "We are pleased that our strong cash generation and balance sheet enables us to return capital to investors while maintaining our ability to invest in our future to sustainably grow our business."
This share repurchase program follows the recent completion of the Company's prior $550 million three-year share repurchase program, which was completed in less than two years.
The amount and timing of shares repurchased under the share repurchase program will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements. Repurchases may be commenced or suspended at any time or from time-to-time at the Company's discretion without prior notice. Repurchases may be made through both public market and private transactions. The Company plans to fund repurchases from its existing cash balance. The Company's Board of Directors will regularly review this capital return policy in connection with a balanced capital allocation strategy focused on funding growth.
I also believe the stock buybacks were a big mistake. The current round is complete and I hope they refrian from any further such mindlessness.
They are all forced to make assumptions about probabilites that are unknowable at this stage of the game, thus the wide array, IMHO.
On the other side of things, hopefully the tax loss selling is about over and we see a modest turnaround a 3 or 4 weeks into the new year. Looks like a bottom hereabouts unless our crack CFO comes up with another financial engineering trick. LOL!
I have no idea what the inderlined phrase means. Can someone interpret that?
Between co-formulation patents, and corporation relation patent opportunities, the company may be able to extend the life of its flagship technology.
Your estimates look reasonable, and as you say, maybe even a little optimistic. So by 2026 halfway to a $Billion. Where does the other half come from in Helen's estimation?
Personally I'm getting the nasty feeling that these PTs are issued so their clients can continue to lighten their positions.
Agreed and I wonder what the text of the recent analyst reports actually says about all of these concerns. At least two (Wells and JMP) have PTs at $58 and $55 respectively (per Benzinga). How do they address the rosy PT outlook in the face of these real uncertainties?
We all know the potential, the question is, where are the deals? We get one every other year when we should be getting one every other month.