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Thank you, Thermo.
Priority review would be a plus :)
I may be getting monies on a company liquidity event here at my work. depending on the timing of the event and PPS at the time, I'm thinking of investing more in OTLK. Your thoughts are greatly appreciated!
Best of luck with your investments.
My understanding is we should see something around the end of this month +/-. There's a decent change we get a Priority Review, which will signal FDA's view of the importance of Lytenava.
I'm thinking about investing more money. My preferred approach is a direct negotiated investment (I'm not in talks now and, if I was, I couldn't mention it). We're in a bear market, so attractive terms are a requirement, but we'll see what happens.
Hi Thermo,
Would you have any insight as to the acceptance of the BLA by the FDA (not the approval, but that acceptance of the filing / they are OK to work with it to set up a PDUFA)? The filing was announced on March 31, 2022.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-submits-biologics-license-application-us
I understand if you can't divulge certain information.
Best of luck with your investments!
OTLK - Corporate Presentation MAY 2022
Good News all as planned
U.S. FDA BLA submitted March 2022 with anticipated approval to follow 9-12 months later.
Sufficient capital through the anticipated approval of the ONS-5010 BLA.
SOURCE:
https://ir.outlooktherapeutics.com/static-files/7590f061-6751-4f3e-89a3-c2101f211735
OTLK - Corporate Presentation MAY 2022
Good News all as planned
U.S. FDA BLA submitted March 2022 with anticipated approval to follow 9-12 months later.
Sufficient capital through the anticipated approval of the ONS-5010 BLA.
SOURCE:
https://ir.outlooktherapeutics.com/static-files/7590f061-6751-4f3e-89a3-c2101f211735
OTLK - Corporate Presentation MAY 2022
Good News all as planned
U.S. FDA BLA submitted March 2022 with anticipated approval to follow 9-12 months later.
Sufficient capital through the anticipated approval of the ONS-5010 BLA.
SOURCE:
https://ir.outlooktherapeutics.com/static-files/7590f061-6751-4f3e-89a3-c2101f211735
OTLK - They Started to Build the Sales Team
Executive Director, Provider Market Access
Job ID 2022-1788 Job Locations US-Remoted
Executive Director, Payer Market Access
Job ID 2022-1787 Job Locations US-Remote
Senior Vice President, Sales
Job ID 2022-1784 Job Locations US-Remote
(See more information about OTLK at r/OTLK_Investors)
Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop and launch ONS-5010 / LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, Greater China and other markets. Outlook Therapeutics expects to submit ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway during the first calendar quarter of 2022.
SOURCE:
https://careers-outlooktherapeutics.icims.com/jobs/search?ss=1
Thanks pfelgueiras!
As guesses go, this one some merit!
1) 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
Posted by VMLG17 on this board.
2) I have seen in the last 10 years of looking at biotech BO's after BLA and before PDUFA
3) That PR you provided states "The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder. "
A BO is at least conceivable. I wonder if the current PPS is ripe for it and what the Buyer would be willing to go on top of the current pps.
Best of luck with your investments.
BioLexis is doing Tax Planning to minimize tax payments selling OTLK shares in a Buyout.
With the agreement among BioLexis, GMS Ventures & Investments (GMS V&I), and certain GMS affiliates on April 21, 2022.
GMS V&I (Venture and Investments) has taken direct ownership of all the shares of Outlook Therapeutics, ...
....that were indirectly owned by GMS Holdings through BioLexis and certain GMS affiliates.
GMS Venture & Investments is a company incorporated under the laws of Cayman Island.
I think they expect to receive a lot of money from the sale of OTLK shares in a Buyout, and are already doing tax planning to minimize tax payments.
Caymen Island is Tax haven for the ultra wealthy and where big business deals happen. They are definitely prepping for something to happen within this year. Count on it !
(See more information about OTLK at r/OTLK_Investors)
Macular Degeneration is a growing health cost for medical systems across the globe. Injecting pharmaceuticals into the eye is not the best way to achieve a high level of patient compliance.
Medicare and Medicaid really needs to find an efficacious treatment to slow the progression of Age-Related Macular Degeneration (AMD) that is cost effective--and easy to deliver.
Eyedrop formulations of Metformin, the broadly used diabetes drug, apparently holds some promise --according to the National Eye Institute which just entered into a clinical trial agreement with a small biotech company (CUBT).
But there is a major push in this field for the NIH to fund clinical trials in this huge market. It cost infinitely more to pay for caregivers of blind pagients vs. slowing the progression to blindness.
OTLK - BioLexis Reorganization Results in GMS Holdings as Largest Shareholder in Outlook Therapeutics ("BUYOUT ON THE WAY?")
April 22, 2022
SINGAPORE and ISELIN, N.J., April 22, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, and BioLexis Pte Ltd. (“BioLexis”), a strategic shareholder in Outlook Therapeutics, today announced that BioLexis is being reorganized.
The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder.
Pursuant to an agreement among BioLexis, GMS Ventures & Investments (“GMS V&I”), and certain of GMS V&I’s affiliates (GMS V&I and its affiliates, “GMS Holdings”), on April 21, 2022, GMS V&I has taken direct ownership of all of the shares of Outlook Therapeutics that were indirectly owned by GMS Holdings through BioLexis.
As the next step in the reorganization, GMS Holdings will cease to be a shareholder in BioLexis and BioLexis will be renamed “Tenshi Healthcare Pte Limited” (or such other name as may be approved by the regulatory authorities in Singapore).
GMS Holdings does not have an economic interest in, or voting rights with respect to, the shares of Outlook Therapeutics that are held by BioLexis. BioLexis directly holds the shares beneficially owned by the minority shareholder in BioLexis, Tenshi Life Sciences Private Limited and Tenshi Life Sciences Pte Limited.
Since the initial investment by BioLexis in 2017, Outlook Therapeutics has undergone a significant transformation and has successfully completed three clinical trials which recently culminated in a BLA submission to the U.S. FDA on March 30, 2022. As the largest investor, GMS Holdings actively supported Outlook Therapeutics by leading and participating in multiple capital raises to support the Outlook Therapeutics growth strategy.
“The submission of a Biologics License Application (BLA) for ONS-5010 / LYTENAVA ™ (bevacizumab-vikg) with FDA is a significant milestone to achieve and places Outlook Therapeutics on a path to potential marketing approval for a very promising therapy,” said Faisal Sukhtian, Executive Director of GMS Holdings and a member of the Board of Directors of BioLexis. “With this milestone accomplished, the shareholders of BioLexis have fully realized their intended objectives for the joint venture.
This reorganization will see the existing partners translate their joint ownership positions in Outlook Therapeutics into direct stakes.”
“We appreciate the longstanding support we have received from BioLexis and look forward to executing on our priorities to create value for all shareholders,” added Russell Trenary, President and CEO of Outlook Therapeutics.
In connection with the reorganization, Outlook Therapeutics and GMS Holdings entered into an Amended and Restated Investor Rights Agreement, which replaces the previous Investor Rights Agreement among Outlook Therapeutics, BioLexis and GMS V&I.
BioLexis no longer has any rights under the Amended and Restated Investor Rights Agreement.
SOURCE: https://ir.outlooktherapeutics.com/node/10356/pdf
OTLK @ Eyecelerator / ASCRS 2022
The Outlook Therapeutics team will be at Eyecelerator @ ASCRS 2022 today in DC. See you there! For more information on $OTLK's ONS-5010 ophthalmic bevacizumab, visit https://t.co/UDq2ox30fb #WashingtonDC #wetAMD #Eyecelerator @Eyecelerator #ASCRS2022 pic.twitter.com/q0x1V8Zvwo
— Outlook Therapeutics (@OutlookTx) April 21, 2022
Many thanks H2R,
I also wish you good profits on your investments, I hope you include OTLK.
I invite you to join r/OTLK_Investors, it was created by me, and I am the moderator.
You can see there a lot of information and opinions about OTLK.
I wish you a Happy Easter.
All the best for you.
Pedro Felgueiras
Thanks pfelgueiras, Great video, it sums up in a nutshell the company's outlook (yeah, I know) for approval.
Best of luck with your investments!
OTLK - Interview about confidence in the FDA approval process for BLA
“Usually to pass FDA you want to have a 95% confidence level that you drug is working…we have in OTLK 99.5% confidence level.”
See the interview with C. Russell Trenary III (OTLK-President & Chief Executive Officer) on Proactive in the link below
Wong board. Sorry about that post on this board. Moderators, please remove Post 468, on the other company.
SA Article
https://seekingalpha.com/article/4499176-cryoport-risky-investment-upside-potential
A few charts comparing PPS with net income, revenue, debt, total assets...
Best of luck with your investments!
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?
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