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BLA submission planned for Q1: a few days left
The March investor presentation kept the BLA submittal for Q1 2022:
"U.S. FDA BLA submission targeted for calendar Q1 2022 with anticipated
approval to follow 9-12 months later"
Hi Thermo,
Your posts have that honesty and rational ring to them. I appreciate your sharing your thoughts with others. And I bet I am far from the only one.
Compared with a number of other biotechs with high potential, the OTLK story is more straightforward.
I hope they continue to keep their planned timeline and that we hear about the BLA submission within the next couple weeks or so, as per their Feb. 14th PR "With the registration clinical trials completed, Outlook Therapeutics plans to submit a new BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022. "
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-financial-results-first-quarter-0
Best of luck with your investments!
Thanks dennisdave!
That's quite encouraging.
Cheers!
Hi Thermo,
A friend of mine was at the New Orleans SECO (I think that's the one) conference and talked to the exhibitors, including the folks at Eylea.
She asked about a number of things including their pricing and the reps said they did not see any price changes for Eylea in the near future.
(They also said they had 80% of the market, so what should we believe).
Anyways, one data point on the pricing.
And Vabysmo is going to be highly priced too:
https://www.fiercepharma.com/pharma/nod-hand-can-genentech-roche-challenge-regeneron-s-eyela-vabysmo
(Another nice PPS action today :)
Best of luck with your investments!
Board's confidence in business model and outlook
At this stage in the company, I believe the board's confidence is warranted.
Jerrell Shelton, Cryoport CEO, said, "The authorization of the repurchase program reflects our constant focus on shareholder return and effective capital allocation. The authorization of this repurchase program demonstrates the Board's confidence in our business model and outlook, our financial performance, and our commitment to delivering value to our stakeholders. We plan to opportunistically repurchase shares of our common stock and convertible senior notes, while maintaining ample liquidity to support our growth organically and through potential acquisitions."
$100M Repurchase Program
Cryoport Authorizes $100 Million Repurchase Program
NASHVILLE, Tenn., March 11, 2022 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or the "Company"), a global leader in temperature-controlled supply chain solutions for the life sciences industry, today announced its Board of Directors has unanimously authorized a repurchase program, under which Cryoport may repurchase up to $100 million of its outstanding common stock and/or convertible senior notes.
Jerrell Shelton, Cryoport CEO, said, "The authorization of the repurchase program reflects our constant focus on shareholder return and effective capital allocation. The authorization of this repurchase program demonstrates the Board's confidence in our business model and outlook, our financial performance, and our commitment to delivering value to our stakeholders. We plan to opportunistically repurchase shares of our common stock and convertible senior notes, while maintaining ample liquidity to support our growth organically and through potential acquisitions."
Repurchases may be made from time to time on the open market or otherwise, in such quantities, at such prices, and in such manner as determined by management at its discretion and will depend on a number of factors, including the market price of Cryoport's common stock, general market and economic conditions, and applicable legal requirements. The repurchase program will expire on December 31, 2025 and may be extended, suspended, modified or discontinued at any time. The company does not expect to incur debt to fund the repurchase program.
Hi Thermo,
I stumbled upon this article:
https://www.healio.com/news/ophthalmology/20220131/fda-approves-vabysmo-for-treatment-of-wet-amd-dme
https://www.fiercepharma.com/pharma/nod-hand-can-genentech-roche-challenge-regeneron-s-eyela-vabysmo
I don't get answers from OTLK's IR.
Do you have a sense of the impact on the overall market (Wet AMD...) by any chance? And OTLK's potential with this new player?
Thanks!
Hi Thermo,
Thanks for taking the time.
I was not thinking of NWBO's BO, I was thinking of OTLK, and if the steps you outlined for "that other company" would be applicable to OTLK, especially given what seems to be incentive to do so for the C-Suite.
Whichever way (BO or commercial), I am very bullish on OTLK.
Thanks again!
Best of luck with your investments!
Thanks pfelgueiras, I do like insiders buying at those prices.
Best of luck with your investments!
Hilzinger, Director: purchase 175k shares for $256,970
Insider Buy: Outlook Therapeutics
BY MT Newswires
05:45 PM EST, 02/23/2022 (MT Newswires) -- Kurt J Hilzinger, Director, on February 22, 2022, executed a purchase for 175,132 shares in Outlook Therapeutics ( OTLK) for $256,970. Following the Form 4 filing with the SEC, Hilzinger has control over a total of 198,249 shares of the company, with 198,249 shares held directly. The market value of the direct and indirect holding, based on the transaction price, is approximately $285,479.
Increasing capacity to meet strong demand
One of the take-away for me during the CC was the obvious demand fueled by the continued investments in biotech industry which leads directly to feeding the pipeline. That demand requires more capacity to simply address it and the demand is not projected to stop. It's a moving train.
That is shown in turn in the number of clinical trials in the pipeline as of now.
http://ir.cryoport.com/~/media/Files/C/Cryoport-IR/reports-and-presentations/fourth-quarter-2021-in-review.pdf
The CC did a good job at highlighting this point.
Best of luck with your investments!
$628M in cash/cash equivalents/short term investments
http://ir.cryoport.com/~/media/Files/C/Cryoport-IR/reports-and-presentations/fourth-quarter-2021-in-review.pdf
Best of luck with your investments!
Hi Flipper44,
I hope to see more posts from you, maybe once the company starts to communicate on the data.
You are one of the most knowledgeable posters on this board and lots of longs will miss you, you can put me in this category.
Whatever you decide, thank you for your invaluable contributions; best wishes Flipper 44!
Best of luck to Patients, NWBO, and Longs!
Scotty, wrong again.
Don't hate NWBO Scotty, it aims at curing cancer. Not a bad goal in life.
Nov 16, 2021 Roundtable Event
From the OTLK Website
https://ir.outlooktherapeutics.com/events/event-details/outlook-therapeutics-present-virtual-investor-roundtable-event
Is very convincing, especially when hearing what the two doctors have to say in their own practice, the % of off-label avastin used (pretty much the typical 50% noted in OTLK's presentations), the issues with that off-label usage, them looking forward to a safer/more predictable alternative.
Then hearing from the commercial side, really reassuring. They have a good team.
It's about one hour, but very much worth it. I added another slice yesterday based on that presentation.
It may take a year, maybe two, (or much faster if BO of course), but I'm even more confident in OTLK today.
I watched a couple more presentations, but when it's only from the company's CEO, I find it less effective. My personal slant.
Best of luck with your investments!
Do you know what color red is? Or do you enjoy being wrong every day?
Cash/cash equivalents: $70.2 million on 12/31/2021
Financial Highlights for the Fiscal First Quarter Ended December 31, 2021
For the fiscal first quarter ended December 31, 2021, Outlook Therapeutics reported a net loss attributable to common stockholders of $14.5 million, or $0.08 per basic and diluted share, compared to a net loss attributable to common stockholders of $14.5 million, or $0.12 per basic and diluted share, for the same period last year.
In November 2021, Outlook Therapeutics closed a $57.5 million gross proceeds equity offering, including full exercise of underwriter’s option to purchase additional shares, which is expected to provide funding to the anticipated approval of the ONS-5010 BLA expected in the first calendar quarter of 2023.
At December 31, 2021, Outlook Therapeutics had cash and cash equivalents of $70.2 million.
Upcoming Milestones / PR 2022-02-14
* Planned submission of new BLA to the FDA in the first calendar quarter of 2022;
* Ongoing pre-launch commercial planning underway in anticipation of potential approval for ONS-5010 within the next 12 months;
* Completion of the NORSE SEVEN study evaluating Outlook Therapeutics’ vial delivery system versus a pre-filled syringe of ONS-5010 in calendar 2022; and
* Continued preparation for NORSE FOUR (BRVO) and NORSE FIVE and NORSE SIX (DME) evaluating ONS-5010 for additional ophthalmic indications in calendar 2023.
Got it. Thanks Am813.
Cheers!
Hi Newman,
Credit goes to Am813 who had a phone call with Dr. Prins.
Cheers!
Best of luck to Patients, NWBO, and Longs.
Interesting response from Dr. Prins.
He couldn’t tell me anything about the data or what fda was going to do but he did say the paper is written and submitted to a journal.
CYRX to Resume Production at New Prague Facility
NASHVILLE, Tenn., Feb. 9, 2022 /PRNewswire/ -- Cryoport, Inc. (Nasdaq: CYRX) ("Cryoport" or the "Company"), a global leader in temperature-controlled supply chain solutions for the life sciences industry, today provided an update on resumption of activities at the New Prague facility. As previously announced, a fire occurred in a portion of the MVE Biological Solutions manufacturing facility located in New Prague, Minnesota on January 25, 2022, causing production to be temporarily curtailed. The New Prague facility manufactures aluminum dewars and is one of MVE Biological Solutions' three global manufacturing facilities.
Cryoport expects to resume production at the New Prague facility during the week of February 14th and ramp up to full production during the first quarter of 2022. The Company anticipates the revenue impact of $4 to $5 million to be limited to the first quarter. Furthermore, the Company expects its insurance to cover the majority of the costs to restore and re-open the facility, as well as related business interruption losses.
(PDUFA) target action date of November 30, 2022
https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-fda-acceptance-new-drug-application
Cheers!
CYTK: FDA accepts NDA application for OMECAMTIV MECARBIL
Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil that enrolled over 8,000 patients in 35 countries across 945 sites.
Got myself another slide this week in small chunks. The PPS is not far from the yearly low.
Looking forward to the upcoming events (preBLA is they even announce it, BLA submittal, Acceptance of BLA, maybe journal publication...). I hope they don't take another year, it's been long enough.
Best of luck with your investments!
Wait, you have not sold yet?? It's pretty easy, put in the order. Done.
Sell the 'many' shares you have. Quick, before it collapses. Hurry up.
Best of luck to Patients, NWBO, and Longs!
Fire at the New Prague Facility
http://ir.cryoport.com/news-releases/2022/01-31-2022-223509366
I had been wondering why the crazy drop for CYRX until I saw this article.
While Cryoport anticipates that the reduced operations at the New Prague facility will adversely affect Cryoport's financial results for the first, and possibly second quarter of 2022, Cryoport does expect that a significant share of the loss resulting from the fire damage will be covered by its property and business interruption insurances.
Cryoport partners with Cell Matters to provide cryopreservation services
http://ir.cryoport.com/news-releases/2022/01-27-2022-133147012
Key aspects of the partnership:
* Cell Matters and Cryoport Systems will launch a joint service to support the development, the optimization, and the actual cryopreservation of leukopaks for preclinical, clinical, and commercial use. The partnership will solve the main challenge of cell therapy manufacturers which is the timely supply of high-quality manufacturing-ready leukopaks;
*Cryoport Systems and Cell Matters will provide clients with a new comprehensive suite of cryopreservation solutions.
Cell Matters, a Belgian based company, enhances cell therapy productivity by turning cryopreservation into a competitive advantage, offering an integrated set of GMP services, in line with regulatory, quality and GMP requirements of the cell therapy industry. The Company uniquely combines expertise in cryobiology, cell therapy production, and bio-logistics. Further, Cell Matters has launched a cryopreservation platform dedicated to the cryopreservation of leukopaks with the first international cell therapy customers currently onboarding.
Upcoming Milestones
From today's PR:
http://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-corporate-update-and-business
* Planned submission of new BLA to the FDA in the first calendar quarter of 2022;
* Execution of the NORSE SEVEN study evaluating Outlook Therapeutic’s vial delivery system versus a pre-filled syringe of ONS-5010;
* Ongoing pre-launch commercial planning underway in anticipation of potential ONS-5010 approval; and
*Continued progress on preparation for NORSE FOUR (BRVO) and NORSE FIVE AND SIX (DME) evaluating ONS-5010 for additional ophthalmic indications.
If the BLA is approved as anticipated in the first quarter of calendar 2023, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.
Hi Glider,
I'm not versed in the BO negotiations which may or may not happen (esp. post BLA acceptance). My guess is that OTLK is in a great position to negotiate, i.e. they do not have to sell. They are strongly incentivized (see the SA article), but that's not the only way forward. It may also depend on the interested parties. If a few potential buyers are vying for OTLK, that makes their lives easier.
If a BO occurs though, the return may not be as big as what it could be in 2-3-4 years, but it would be a lot faster. Either way, the percentage of success/great return is high, be it with or without a BO.
I'm just a regular retail investor. I try not to extrapolate too much.
Best of luck with your investments!
Hi Thermo,
I read all your posts since you became 'thermo' (I think you lost an 'o' in some IHub accident :) and posted on 10/27/2016. Lots to learn!
If I may, a couple of questions for you, if that's appropriate.
1) To BO or not to BO: In one post regarding BO (on the NWBO board) when it was a topic at the time (yes, a bit of a manic-depressive board :), you wrote the following steps would :
Remember, NW is still blinded to the data, so any acquirer is blinded to the data, so there is no (near term) acquisition offer.
Data lock => analysis => topline => controversy re top line => strategics (maybe) kick the tires => FDA BLA acceptance =>
C Suite BO Incentives
Thanks, VMLG17 for the SA article, lots of good info.
After analyzing some of the CEO COO CFO ... compensation, this is what the author writes:
The point of analyzing all these executive compensation structures is to see the common theme of high incentivization for the whole board to find a buyer for Outlook.
Bought another OTLK slice, could not resist Mr. Market latest offer :)
Best of luck with your investments!
Hi pgsd,
This is the quote from Lykiri's message:
I asked the London Neurosurgery Partnership about the availability of DCVax-L.
13 neurosurgeons / London Neurosurgery Partnership
The whole email is big.
This partnership in particular means a bigger 'footprint' to share the info around DCVax internally in the partnership and externally in their respective pratice/hospitals/patients.
I'll echo the sentiment of many longs on this board: You the man!
Best of luck to Patients, NWBO, and Longs!
Consistent timelines, BLA this Quarter!
Thanks pfelgueiras for the updated company presentation, https://ir.outlooktherapeutics.com/static-files/8a3fe36f-d7e7-4453-806b-2ffbfeb502c3, https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167475302
My favorite slide:
Looking forward to the BLA submission PR this quarter.
Best of luck with your investments!
Positive Outlook @ JP Morgan Presentation
1) The acquisition to continue to fuel growth
2) The 2022 outlook
https://ir.criver.com/static-files/f92d7468-bf01-4c5f-9bdb-7015940ab25a
Following the strategy, this looks good medium term/long term.
Best of luck in your investments!
Thanks Reefrad,
They keep executing on their strategy. It takes time but the steps are clear and the manufacturing step is now complete (without FW). It's consistent.
Best of luck to Patients, NWBO, and Longs!
It was a simple question Sushifishman. I'll still say thank you for your opinion, even if your tone is disrespectul. And FYI, i don't post on that other board.
Cheers