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BLA SUBMITTED!!! LYTENAVA™ is brand name
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-submits-biologics-license-application-us
They did keep their timeline. The PR is what was expected:
I believe BLA submission news before 4/1.
BLA submission planned for Q1: a few days left
The March investor presentation kept the BLA submittal for Q1 2022:
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!
A follow-up to my prior comment.
I'm not a cheerleader for my investments. I will be honest with people about both the promise and the peril. So, if anyone took my last comment as unduly negative, I want to be clear. OTLK is one of my favorite longs.
The pricing risk in wAMD is nothing new. I considered it when I first established my position at $1 and I don't think the pricing risk is evolving differently than I first expected.
My target is still $10. If I believed what management is telling me about their hopes/expectations my target would be higher.
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!
I've heard from docs that faricimab is quite good and they expect to transition many of their patients currently on Eylea to faricimab.
So, Eylea will be pressured by faricimab and biosimilars. Pricing will come down. Biosimilars will price at 60% - 70% of Eylea, or around $1000 or perhaps $800.
But the need for cost control in healthcare isn't going away (e.g. the use of step edit protocols). The regulations that will cause doctors to stop prescribing an off-label drug when a comparable on-label is available isn't going away. These are the key realities behind my OTLK forecast.
I ask myself, what's my margin of safety with OTLK? How wrong can I be on my forecast and still be right on the stock? I find that to be, still, a very wide margin.
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!
Could be $3-$4+ after BLA announcement.
Company said to file BLA Q1 2022. So I think it will happen in next 3 weeks.
got it... an OTLK buy-out is possible. I think there have been discussions before and, for a strategic that already has the right sales force, the economics of adding a high margin product will be compelling.
We could see something before an FDA decision but, if early sales ramp as I expect, OTLK will be hard to ignore.
My peak rev assumption is $1B but it is possible to get to a $2B number if the stars align.
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!
H2R, sorry I didn’t respond… I haven’t been on these boards for a month.
I think it’s too early for buyout negotiations. Although I can see a very large potential market for DCVax, I can also see other questions that have to be answered before large pharma steps in. They are very risk adverse. That said, I’m not bothered by that at all. I really never think about buyouts. They happen when everything is going well but I just focus on if a company is trending toward doing well, which is certainly the case with NWBO.
W.R.T. 9 meters biopharma. I own it but I’m not buying more down here. Once I have a relationship with management (which is the case here), I tend to keep a least a small position and stay in touch in management. If something changes, I’ll notice and scale up.
Glad to see you here in OTLK. Institutional investors are skeptical, thinking ONS 5010 won’t get much penetration, but management very optimistic. Step edit programs / health care cost issues aren’t going away and the next innovation isn’t changing that.
Thanks H2R
All the best also for your investments.
Best Regards
Pedro Felgueiras
Thanks pfelgueiras, I do like insiders buying at those prices.
Best of luck with your investments!
HILZINGER KURT J. report that he bought more 47.160 OTLK shares, now he have 245.409 OTLK shares.
Another INSIDER BUY in OTLK!
HILZINGER KURT J. , report on SEC FORM 4 that he bought more 47.160 OTLK shares, now he have 245.409 OTLK shares.
On February 24, 2022 bought 41,160 OTLK shares at $1,46
On February 28, 2022 bought 6,000 OTLK shares at $1,60
SOURCE: https://ir.outlooktherapeutics.com/static-files/25d8b5d5-77c5-445a-9c66-334215960ccd
"OTLK It's not a Trade, it's a Project. Becoming a Millionaire takes work!"
also:
"THE BIG MONEY IS NOT IN THE BUYING AND THE SELLING, BUT IN THE WAITING"
See more information about OTLK at r/OTLK_Investors
pfelg, you were close, but a little more time is needed until the pps reaches $2. As OTLK management has stated, the BLA should be completed by end of 1Q 2022, or any day now, and the corresponding PR should also boost the share price with FDA approval being very possible before the end of the year. Hopefully, that momentum will be maintained headed into 2023.
Hilzinger, Director: purchase 175k shares for $256,970
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!
OTLK I believe Price above $2 end of February 2022!
Today OTLK was GREEN and Price UP +7,1%, was a good day for OTLK!
Also After Market the OTLK Price continues to go UP.
The Form 25 is regarding OTLKW Series A Warrants going Away on is exercisable date Feb 18, 2022. (See FROM 25 SEC).
Source: https://ir.outlooktherapeutics.com/static-files/bb95874b-d49f-4a22-847b-e733a25d2932
Can be one more step to the Buyout!
(See more information about OTLK at r/OTLK_Investors)
Cash/cash equivalents: $70.2 million on 12/31/2021
Upcoming Milestones / PR 2022-02-14
OTLK is looking for Director of Financial Planning and Analysis
"(Maybe hire someone else from AmerisourceBergen to plan and organize the Buyout)"
Opportunity and Summary of Position:
Director of Financial Planning and Analysis will oversee the budget and finances of the company.
Reporting Relationships:
The Director of Financial Planning and Analysis at Outlook Therapeutics’ reports to the Financial Controller.
Position Responsibilities:• Forecasting, budgeting and long-range planning.• Decision support on initiatives and investments.• Performance analysis and management reporting.• Identify and drive profitability and cash flow improvements.• Preparing revenue projections and forecasting expenditure.• Link revenue forecasts with margin expectations.• Develop mid and long-range strategic plans.• Ensure investment strategies support cost savings.• Evaluate resource investments and provide recommendations.• Track business case results with closed loop to forecast and budget• Produce KPIs with scorecards for each cost category.• Perform analysis on all operating metrics and KPIs.• Results v budget with variance analysis and explanation. Evaluation of gap closure initiatives with tracking• Support Business unit and product profitability. Business Unit and Product margin views• Synergy and integration tracking. Drive process and organizational efficiency initiatives• Creates and implements business plans, projections, budgets, and other single and multi-year analysis projects.• Collaborates with other departments and senior leadership to establish an effective budget for the organization.• Provides relevant financial information to executive management team.• Communicates with management on behalf of the Chief Financial Officer.• Collaborates with the Chief Financial Officer and Financial Controller and assists as needed for all matters related to the organization’s financial, planning, and budget programs.• Performs other related duties as assigned.
**Candidate Qualifications:**The company is seeking an individual with the following qualifications and who is willing to make a long-term commitment to the organization:
Education/Certificationo Bachelor’s degree in accounting, finance or business required; MBA and/or CPA preferred.o Bachelor’s degree with 10-15+ years of experience in Finance and Business management roles, preferably FP&A.o Strong presentation, interpersonal, and written skills.o Leadership experience in people management, program management and a strong track record of effectiveness in execution, time management, and influencing to deliver objectives.o Strong execution orientation and ability to inspire action.
Qualifications and Skillso Exceptional verbal and written communication skills.o Excellent organizational skills and attention to detail.o Ability to prioritize and delegate tasks.o Ability to analyze and evaluate budgets and financial models.o Ability to create and present ideas and budgets in a variety of formats.o Ability to maintain confidential records.o Proficient with Microsoft Office Suite or related software as needed to create and analyze budgets.
CompensationAn attractive compensation package will be offered to the successful candidate. It will include a competitive base salary and incentive bonus. A benefits package customary to the position will also be provided including 401k match, medical and dental.Outlook Therapeutics is an equal opportunity employer.
Interested applicants can send resumes to: HR@outlooktherapeutics.com
Source: https://outlooktherapeutics.com/director-fpa/
only the shareprice isn´t going where it should be :)
OTLK - Corporate Presentation February 2022
Everything goes as planned!
Source: https://ir.outlooktherapeutics.com/static-files/b4e4a969-af03-4f17-9680-882c1c84239d
Upcoming Milestones
From today's PR:
http://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-corporate-update-and-business
Top 10 Hedge Funds Holding OTLK
In total we count 55 hedge funds holding OTLK as of their latest 13F filing, but among those we've sorted out just the top ten hedge funds holding OTLK by largest position size, and presented them here in slideshow format.
#1. BlackRock Inc.
#2. Vanguard Group Inc
#3. LVW Advisors LLC
#4. State Street Corp
#5. Geode Capital Management LLC
#6. Millennium Management LLC
#7. Northern Trust Corp
#8. Stelac Advisory Services LLC
#9. Two Sigma Advisers LP
#10. Nuveen Asset Management LLC
See more information about OTLK at r/OTLK_Investors
Source: By Holdings Channel Staff, updated Tuesday, January 25, 2:24 AM
Appreciate it.
Id also rather it happen sooner than years later
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!
Question;
If they are seeking a buyer, wouldn't that lower the value of the company especially if they are in a hurry?
Is this the norm with them?
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 :
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:
Bullish Jan. 21, 2022 Seeking Alpha article: https://seekingalpha.com/article/4480794-outlook-therapeutics-fda-approval-possible-buyout?mailingid=26453681&messageid=must_reads&serial=26453681.108183&utm_campaign=Must%2BRead%2BJanuary%2B22%2C%2B2022&utm_content=seeking_alpha&utm_medium=email&utm_source=seeking_alpha&utm_term=must_reads
Bought another OTLK slice, could not resist Mr. Market latest offer :)
Best of luck with your investments!
$OTLK Buyout?
Where will NOVARTIS spend the $20.7B from Roche stake sale?
Novartis pharma division’s chief financial officer Mukul Mehta highlighted eye and respiratory diseases as possible areas for bolt-on deals, Welford noted in a Wednesday note after talking to the executive.
Novartis is getting a huge influx of cash from selling its 20-year stake in Roche, triggering speculation about where the Swiss pharma will spend the money $20,7B
What will it be next NOVARTIS M&A move? ...OTLK?
Another large acquisition could be next, with a familiar face now reportedly on the shopping list.
Buy on rumors, sell on news!
See more information about OTLK at r/OTLK_Investors
Oncology belongs to a different division at Novartis.
OTLK - The pre-offer of a Buyout has started? (More opinions I read regarding a OTLK Buyout)
"I Think the pre-offer buying of OTLK Buyout has started!"
A buyout will be based on the value to the buyer, not the share price.
A low share price means a potential buyer may try to buy up as many shares pre-offer as possible.
Let's say you offer $30/share.
If you accumulated 10MM shares before the offer was made, you saved $300MM dollars.
If someone beats your offer, you still sell those 10MM shares for a profit.
I think this is why we are seeing bear raids and FUD accounts.
I think the pre-offer buying has started.
I expect an offer to be announced around the time the FDA accepts the BLA.
Any offer will be based on the buyer's valuation.
Whoever has the highest valuation will make the highest offer.
Share price won't matter a lick.
So a $30/share offer is reasonable, if a buyer thinks the value is there.
This is why I keep saying that none of us has enough information to know what the offer will be.
But I think it will be $8-$12MMM . Or less. Probably not more. I would be amazed if it's less than $5MMM
For more information about OTLK, see at r/OTLK_Investors
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!
for me that way is not working but Itried it otherwise and now it´s working. thanks for the link anyway. :)
$OTLK JTC Team to Host Virtual Investor 2022 Top Picks Conference on January 25th
PITTSTOWN, NJ / ACCESSWIRE / January 12, 2022 /JTC Team ("JTC"), a fully integrated corporate communications and investor relations firm, today announced it will host the Virtual Investor 2022 Top Picks Conference January 25-27, 2022. As part of the virtual event, JTC partnered companies will provide a corporate presentation, followed by an interactive Q&A session.
The schedule for the event is as follows:
Tuesday, January 25, 2022
3:00 PM ET: Outlook Therapeutics, Inc. (Nasdaq:OTLK) - WEBCAST
- Access the event and schedule of presenting companies at virtualinvestorco.com -
- Live video webcast presentations of participating companies followed by interactive Q&A session -
Its working.
I copy r/OTLK_Investors to google and works.
OTLK - Corporate Presentation January 2022
Good news, ...everything is progressing as planned.
For more information about OTLK see at r/OTLK_Investors
Source:
https://ir.outlooktherapeutics.com/static-files/8a3fe36f-d7e7-4453-806b-2ffbfeb502c3
r/OTLK_Investors that is not working. there seems to be missed something?? thx
BO at $40 at some point would be great.
If you want to see more information about OTLK and also about a potential Buyout, take a look at r/OTLK_Investors
Very good posts there.
Hi VML, thanks for the reply. Good to see another investor still watching ;) long term it´s looking very good, just frustrating what we looking at right now. I thought with an average of 1.33 I am good... lol Have a nice week!
GFTB, Thanks for all the OTLK MB posts. I've got many OTLK shares and down 35% as I bought right before the recent financings last year. I watched the HCW event this morning and liked what the CEO had to say. The trail was designed in coordination with the FDA, BLA submission to FDA this quarter, and a good chance of FDA approval before YE 2022. They also have a pipeline so the stock should go higher than the 12-month price target of $7-8 pps in '23 and beyond. It also sounds like they are going it alone vs. BO with mention of a sales force to launch revenues.
The video webcast can now be seen.. Link below in the PR from Jan. 4th
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-present-hc-wainwright-bioconnect-conference
did everybody sell here? no communication - only me alone ?
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