Outlook Therapeutics Inc (OTLK)

[Mionaer1]

I know my base scenario is pretty conservative.

[HyperPhoenix1]

I think targeting only 30% of total off label is very low, notably if off-label is prohibited. You can play with the attached model. I think that you should make an assumption on the total market as some doctors will switch from current approved drug (lucentis, vabysmo, Eylea, ...) to Lytenava when approved (Norse 2 show that Lytenave is even better than Lucentis)

https://1drv.ms/x/s!AhwuZfSEtm_qgoFBxevZmhLFSe7lUA?e=v1QBjZ

The input data are % of the total market share per location and price per injection

Model show that stock price above $150 is achievable

[exwannabe]

The recruitment status is a mandatory 30(?) day update. The estimated completion is not.

Regardless, this is not really anything that matters. The trial is clearly on schedule and the results (and BLA amendment submission) will be about as what they have guided.

[H2R]

un bémol:

The primary completion is estimated to be September 2024. Each patient must have a 3 months treatment. We are at the end of July and the study still says Recruiting. Something does not quite add up.

I guess it's possible that they enrolled 400 patients and are enrolling some 'extra' patients to avoid the "Lost To Follow Up" (LTFU), but it's only a 3 months treatment.

I would expect the 'Recruiting' or the 'Primary Completion Date' to change soon on the clinical trials site. Otherwise, something does not add up. And yes, I'm still bullish (very much so).

My 2 cents.

Best of luck with your investments!

[H2R]

Clinical Trials 'Update': Keeping to the estimated dates.

The latest update, dated 2024-07-23 , is simply ... the date of the update, nothing else has changed.

In particular, the estimated primary completion date and study completion date remain the same as it's been since the trial was first entered in Clinical Trials.

I take that as a sign that enrollment continues as planned and that the Company keeps executing to the plan for an FDA submittal at the end of 2024.

Looking good!

Best of luck with your investments!

[Mionaer1]

My base case for LYTENAVA.

Injections off label: 2.8M (Europe) + 3.5M (USA) = 6.3M

Market share: 33% (conservative) = 2.079M

Average Price: $400 means sales $831.6M

Market Cap: 831.6*4 (conservative multiple) = $3.326,4M

FD Shares: 40M (Thermo 800-850 before R/S)

My target price/PPS: $83

OTLK is a potential tenbagger IMO

[exwannabe]

UK and NICE. In the UK the NICE guidance establishes how the NHS will pay for and use drugs.

Read through the most recent guidance for wet AMD. In short, it does not pay for bavi because it is not approved for the indication. It also says generic Lucentis should be used as first choice (because it is cheaper than branded).

What does this mean for Lytevana when they go to NICE to update the guidance?

First, there is no price pressure form the off label bavi. That is very good.

Second, I would guess that they would basically try to split the non branded market with generic Lucentis,

IMO, this is good. My concern with markets like the UK has been they will force the price down close to the off label bavi. And that does not look to be the case.

Have no clue about all the other dozens of EU states,.

[H2R]

Hello HyperPhoenix1,

Your guess as to why the PPS is not rising more rapidly would be as good as any.

Mine is caution after the FDA CRL last year. I believe that Norse 8 will lead to US approval in mid-2025 and that may be what 'the Market' is looking at, together with the first quarter of sales in Germany and the UK. In other words, the Market sense may be that there is time to invest at this point. From my perspective, I see it as an opportunity to add.

Once sales kick in, I do not see the PPS going lower, and as a few of us on this board (including you) are 'guestimating', the PPS could rise quite significantly to warrant a serious investment. I don't need a specific PPS target on a calendar date. I need to know the business model makes sense and the probability for executing on the plan is high.

Best of luck with your investments!

[HyperPhoenix1]

Thank you. If you play with the model, you will see that in all scenarios, the upside is huge. Even without FDA approval, x7 to x10 on current stock price seams easily achievable. I cannot understand that the market did not value the european and now UK market authorization. Have a nice week end

[H2R]

I took a closer look, I really like the structure you put together. I may play with slightly different numbers on my free time. You put together a really nice and clear model.
Thanks so much!

Best of luck with your investments!

[H2R]

Hello HyperPhoenix,

Thank you for clarifying the basis for the hypothesis, that makes sense.

Très cordialement,

H2R

Best of luck with your investments!

[HyperPhoenix1]

... and to answer more precisely to your question, the number of injections in the model are all brand, including off label for wet AMD only

[HyperPhoenix1]

When I have prepared this spreadsheet, OTLK did not communicate precisely on the number of injections in europe, UK and in the US. So I have estimated myself the total number of injections based on the information I have found (I started with french healthcare database as I am french, and extrapolate based on weight of each country population). Since then, OTLK gave more precise informations on many aspects of the market (off label injections, total injections, ...). My figures are consistent with final OTLK data, so I did not change that in my model, but you can change if you whish. Final outcome will not be very different. Russ is focussing on the share he will take on off-label injections. My model is different. I assume a certain percentage of market share on the global market (35% for Europe, 50% for the USA). Lytenava being even better than Lucentis, certainly with a cheaper entry point. So I imagine OTLK could grab some % of market share on the other premium brand.

[H2R]

Hello HyperPhoenix,

Thank you for putting together this work sheet, very appreciated.

The assumptions are taken from the XL :

Number Injections, 2024
France 1,032,783 Based FrenchHealth Database (2016) plus market growth
Europe 6,905,772 Pro Rata based on the french propulation vs EC
UK 1,032,783 UK has same population than France
USA 9,139,783 I used the ratio of treated patients (US/Europe) according to OTLK ppt

Russ Trenary talked about 2.8M injections of bevacizumab in the EU, and 3.5M in the US. That is what I believe OTLK's target market is, provided US approval.

Is your overall assumption that OTLK is targeting the entire market, including all other therapies and the number of injections is the above? Or ONS-5010 will capture more than the current Wet AMD?

I am optimistic about the future of OTLK and the PPS (see my simple/back of the envelope aspirational revenue target). I want to better understand where you are coming from.

Thank you!

Best of luck with your investments!

[HyperPhoenix1]

Hello all OTLK investors
I have prepared this comprehensive model for the valuation of OTLK (click on the link and play with the excel model)
It is easy to modify the hypothesis, which are pricing points in Europe, UK and USA and the related market share.
The model factors the upcoming dilution, deferred tax, and included a 11% discount rate on future cash flow. No inflation hypothesis, as it is likely that price will decrease over time because of competition with other product and biosimilars. Even with reasonable assumptions, we have x30 vs my average stock price (8.6). Without US, x10 ! enjoy

https://1drv.ms/x/s!AhwuZfSEtm_qgoFBxevZmhLFSe7lUA?e=v1QBjZ

[Golden Bear 86]

Thermo, Could certainly use your analysis on this question…. is there a way to estimate a share price of the company if they did not get approved in the US and they were a standalone business in Europe/UK?

[H2R]

OTLK hitting again a planned date, here ahead of time.

This Company has a great track record of executing along announced planned dates and hitting those dates.
During the June 18th presentation, Russ Trenary said they could have a decision from the UK in the next 30 to 60 days. It took even less time.

Best of luck with your investments!

[H2R]

ONS-5010 v. "risk of rare but potentially devastating endophthalmitis" of compounds

Thanks for highlighting this paragraph OGBritBox!

The full sentence from King's College London to be read in light of the legal aspects of approved ONS-5010 v. un-approved Bevacizumab:

" Additionally, a well-controlled pharmaceutical manufacturing operation will allay concerns that compounding pharmacies increase the risk of rare but potentially devastating endophthalmitis."

Who wants to be liable for potential damage to the eye when compound should not be used after approval from a legal standpoint?

Best of luck with your investments!

[H2R]

UK Approval PR

ISELIN, N.J., July 08, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the UK. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK.

Professor Tim Jackson, PhD, FRCOphth, Consultant Ophthalmic Surgeon, King's College Hospital and Professor of Retinal Research, King’s College London, commented, “We have waited a long time for a brand of bevacizumab that is authorized for eye use, and it is good news that LYTENAVA™ has now entered the market. This occurs subsequent to Outlook Therapeutic's clinical trial meeting its endpoint. To date, many ophthalmologists have been hesitant to use an off-label bevacizumab, when licensed products are available. We value being able to utilize products that meet the standards required for marketing authorization. Additionally, a well-controlled pharmaceutical manufacturing operation will allay concerns that compounding pharmacies increase the risk of rare but potentially devastating endophthalmitis.”

This approval comes after Outlook Therapeutics was recently granted Marketing Authorization for LYTENAVA™ (bevacizumab gamma) by the European Commission for the same therapeutic indication. The Marketing Authorization Application (MAA) submission to the MHRA was completed under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the European Medicines Agency’s CHMP concerning an application for granting marketing authorization for the same product in the EU in the MHRA’s authorization decision.

“We are pleased to receive UK approval on the heels of marketing authorization in the EU for LYTENAVA™ (bevacizumab gamma). This milestone achievement is the final regulatory step towards our expected commercial launch in the EU and UK in the first calendar quarter of 2025. Our team continues to make a concerted effort to bring to the UK market the first and only authorized ophthalmic bevacizumab for the treatment of wet AMD. We are grateful to all the patients, researchers, clinical sites and the MHRA for the research, drug development, and regulatory efforts that led to this approval,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics.

Jedd Comiskey, Senior VP – Head of Europe for Outlook Therapeutics, added, “MHRA approval represents a very important milestone for Outlook in the execution of our commercial launch plans for LYTENAVA™ (bevacizumab gamma) in the UK. Our team continues to work hand in hand with our commercialization partner, Cencora, to support our launches in the EU and UK anticipated in the first calendar quarter of 2025, and we are looking forward to an exciting year ahead.”

As part of a multi-year planning process, Outlook Therapeutics entered a strategic collaboration with Cencora (NYSE: COR) (formerly AmerisourceBergen) to support the commercial launch of LYTENAVA™ globally following regulatory approvals.

Cencora will provide comprehensive launch support in the EU and the UK including pharmacovigilance, regulatory affairs, quality management, market access support, importation, third-party logistics (3PL), distribution and field solutions. The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA™ to benefit all stakeholders, including retina specialists, providers and patients.

“We have been working closely with Outlook Therapeutics to develop and execute a global launch strategy and are thrilled to help them bring this therapy to market in the UK and the EU,” said Cencora’s John W. Arena, interim president of Global Pharma Services and senior vice president of Enterprise Strategy & Solutions. “We will continue to leverage our infrastructure and pharmaceutical services to support a successful commercial launch of LYTENAVA™ and ensure healthcare providers have timely and reliable access to the therapy.”

Best of luck with your investments!

[H2R]

UK MHRA Marketing Authorization of LYTENAVA™

That's one news I was hoping for !

* UK MHRA marketing authorization follows recent European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) in the EU for the treatment of wet AMD

* Initial commercial launches of LYTENAVA™ (bevacizumab gamma) in the EU and UK anticipated in calendar Q1 2025

* Strategic partnership with Cencora (formerly AmerisourceBergen) to support the planned commercial launches of LYTENAVA in UK and EU

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-uk-mhra-marketing-authorization

Best of luck with your investments!

[H2R]

Thanks Thermo,

Consistent information from BTIG, the Company keeps executing on a clear plan, and additional information (for me anyways) around Compound Pharmacies, starting with

Compounding will become a question of supply, not just demand once ONS-5010 is available. Only two compound pharmacists, Fagron (FSE: FAGR.BR, Not Rated) and Leiters (Private), obtain bevacizumab via distributors. These two pharmacies are unable to ramp up production meaningfully if needed due to the thin margins on bevacizumab. Other compound pharmacists, such as Pine (Private) (responsible for producing almost half of all off-label bevacizumab injections), receive bevacizumab through drop-shipments from physicians. If physicians choose not to ship IV bevacizumab to compounders, we expect the manufacture of off-label bevacizumab as a whole will start to decrease. We are already starting to see physicians shift away from off-label bevacizumab. Mgmt. shared that KOLs are already starting to acknowledge the shortcomings of off-label bevacizumab in reaching ophthalmologic standards. With greater education and increased awareness, mgmt. expects more physicians will opt for an approved product and stop facilitating the manufacture of off-label bevacizumab.

The legal aspect has been made clear for a while now. The question of supply is interesting and adds to what could be a momentum to move to ONS-5010. Plus the other 'real world' paragraph you posted.

Thanks Thermo!

Best of luck with your investments!

[thermo]

Outlook Therapeutics (OTLK) / BTIG Research / JULY 8, 2024

NDR Recap: We See a Straight Path to BLA Resubmission ~YE24. NORSE EIGHT Enrollment Completion Later in 3Q24 Should Confirm the Timeline.

WHAT YOU SHOULD KNOW:

We hosted meetings this past week with OTLK mgmt where discussions focused on the remaining steps to BLA resubmission, pre-commercial efforts in Europe (EU marketing authorization received in May, launch expected in calendar 1Q25), and how compounded bevacizumab could fall out of favor when LYTENAVA (fka ONS-5010) becomes commercially available. The market opportunities for LYTENAVA in the US and Europe are both large and currently correspond to ~3.5 million and ~2.8 million compounded bevacizumab injections per year, respectively. Since compounded bevacizumab is not held to the same strict regulatory standards as an approved ophthalmic formulation, we think liability associated with off-label use could become more of a concern when a more carefully regulated product (i.e., LYTENAVA) becomes commercially available (Exhibit 1). We also recognize that LYTENAVA's recent marketing authorization in Europe de-risks the upcoming CMC review by the FDA. Remaining steps to BLA resubmission look straightforward to us, with NORSE EIGHT enrollment completion expected later in 3Q24, followed by topline data in 4Q24, BLA resubmission ~YE24, and potential US launch in 2H25.

NORSE EIGHT mirrors the first 3 months of NORSE TWO. NORSE EIGHT involves the same doses of ONS-5010 and ranibizumab as the first 3 months of the previously completed NORSE TWO trial, which showed ONS-5010 numerically outperforming ranibizumab on BVCA as early as 30 days and greater separation at later timepoints (Exhibit 2). We currently assume a 90% probability of success.

NORSE EIGHT in detail, is a 3mo non-inferiority study of ONS-5010 vs. ranibizumab with an abbreviated 2mo primary efficacy endpoint (BVCA; 3.5 letter non-inferiority margin) that plans to enroll ~400 treatment-naive wet AMD patients. Mgmt. previously confirmed that the FDA did not take issue with the design or results of NORSE TWO but rather with the fact that the initial ONS-5010 BLA contained 1 pivotal efficacy trial instead of 2. The FDA has provided written agreement for NORSE EIGHT under an SPA, which provides reassurance that the trial will be sufficient as a second study to support potential approval. Enrollment is underway and is proceeding at an encouraging pace (30% complete as of 5/15/24; target enrollment is 400 treat). Since >90% of sites were active at the start of April (vs. ~50% in March), we see a good chance of the enrollment proceeding in a typical "hockey stick" trajectory from here.

EU approval helps to provide some confidence around the CMC package. Mgmt. noted that both the EMA and the FDA received the same CMC package for review. According to mgmt., the questions around CMC included in the CRL were similar to those often included in information requests during a drug’s review process. Furthermore, the prescriptive nature of the CMC questions supports straightforward resolution of these open items. Mgmt. is continuing to meet with the FDA in scheduled Type C and D meetings to go over the CMC data and has signaled confidence in the ability to resolve the open CMC questions by the time of the expected BLA resubmission (YE24). We think the ongoing engagement with the FDA and approval in the EU based on the same CMC data help remove risk around CMC, and do not see CMC issues as a large concern going forward.

Europe represents the second-largest market for wet AMD, and we expect pricing and reimbursement advantages for LYTENAVA similar to those in the US. While the US is the bigger market opportunity in Outlook’s mind (roughly 3x the size of the Europe opportunity), the overall dynamics driving off-label bevacizumab use are similar. Off-label bevacizumab represents ~40% of the injections in the EU compared to ~50% in the US. In addition, although prices are generally lower in Europe than in the US, branded and biosimilars are still priced at premiums multiples higher than off-label bevacizumab, providing a wide window for Lytenava. Mgmt.’s decision to target Germany and the UK first in pricing conversations make sense to us, given these two countries have the highest prices for anti-VEGFs and are associated with tougher pricing processes. If Lytenava can benefit from the higher ceiling on price in these markets, we think this could act as a good benchmark for other Europe countries as well. Approval in the UK is expected in 3Q24 and mgmt. is planning to launch in both Germany and the UK in 1Q25.

Compounded bevacizumab likely falls out of favor if ONS-5010 is approved by the FDA. OTLK mgmt. believes that compound pharmacists that choose to continue making compounded bevacizumab after ONS-5010 becomes commercially available could put their entire operations at risk. Laws and regulations aside, high particulate counts, less than ideal storage conditions, and lack of reachable/extractable testing are well-known shortcomings of compounded bevacizumab that ONS-5010 significantly improves upon with higher manufacturing standards. Management has also noted that repackaging leads to protein shearing and reaggregation, which likely is another source of high batch-to-batch variability in current off-label bevacizumab use. Interestingly, OMIC (Private), the largest ophthalmic medical malpractice insurer in the US, has indicated that if a patient is being treated with off-label bevacizumab in one eye, they are not going to provide medical malpractice coverage for the second eye. OTLK is also optimistic that state pharmacy boards and the ethics committees at large academic medical centers (many have their own compound bevacizumab operations, currently) will be motivated to seek alignment with current regulations.

Compounding will become a question of supply, not just demand once ONS-5010 is available. Only two compound pharmacists, Fagron (FSE: FAGR.BR, Not Rated) and Leiters (Private), obtain bevacizumab via distributors. These two pharmacies are unable to ramp up production meaningfully if needed due to the thin margins on bevacizumab. Other compound pharmacists, such as Pine (Private) (responsible for producing almost half of all off-label bevacizumab injections), receive bevacizumab through drop-shipments from physicians. If physicians choose not to ship IV bevacizumab to compounders, we expect the manufacture of off-label bevacizumab as a whole will start to decrease. We are already starting to see physicians shift away from off-label bevacizumab. Mgmt. shared that KOLs are already starting to acknowledge the shortcomings of off-label bevacizumab in reaching ophthalmologic standards. With greater education and increased awareness, mgmt. expects more physicians will opt for an approved product and stop facilitating the manufacture of off-label bevacizumab.

Real-world quality of compounded bevacizumab appears much lower than what was studied in the CATT trial. A highly referenced study on compounded bevacizumab's efficacy was conducted by the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group, which enrolled 1,185 patients with wAMD to compare compounded bevacizumab and ranibizumab. The study found that ranibizumab and compounded bevacizumab are equivalent in efficacy, although endophthalmitis was observed with compounded bevacizumab at two times the rate vs. ranibizumab (0.07% vs. 0.04%, respectively). Furthermore, the rate of serious systemic AEs, primarily hospitalizations, was higher among bevacizumab-treated patients than among ranibizumab-treated patients (24.1% vs. 19.0%, p=0.04). There are many who argue that the results were generated from batches of compounded bevacizumab that were of higher quality than what is typically encountered in the real-world setting. On this point, an article was published in JAMA in 2014 detailing how variable the quality of compounded bevacizumab can be in the real-world setting.

Real-world bevacizumab contains lower drug concentrations, leaving efficacy on the table. In the 2014 JAMA study that looked at protein concentration in samples taken from 11 different compounding pharmacies in the US, all samples were found to have protein concentrations lower than the bevacizumab control taken from Genentech (RHHBY, Not Rated). 81% of these samples (n=17/21) had significantly lower protein concentrations with a mean of 22.2mg/mL across compounded pharmacy samples (vs. 25mg/mL for Genentech's sample, p<0.05). Protein concentrations of the compounded samples varied and this inconsistency and overal lower levels of drug concentration could explain why over 40% of patients switch to a branded anti-VEGF by the third year of treatment. An approved product is expected to be held to more rigorous standards of drug manufacturing, so we see a good chance ONS-5010 is a better product based on having higher, more consistent levels of protein concentration.

Compounded bevacizumab falls short of FDA standards for ophthalmologic drugs. Compounded bevacizumab is currently made from Avastin, a drug approved for oncology indications and delivered through IV infusion. Avastin, as an injection, is expected to comply with USP <788> standards which limits particulates of ≥10µm to 6,000 per container. Opthalmologic formulations are held to a high standard and are expected to comply with USP <789> which limits particulates of ≥10µm to only 50 per mL. On top of that, since compounded bevacizumab is derived from an oncology product, it has not been designed to meet ophthalmic standards for bacterial toxicity, shelf-life stability and potency, and specifications related to pH and osmolarity. Mgmt. pointed out that doctors could start to associate liability with using an off-label product that does not comply with FDA-recognized USP standards if an approved product with the same API is also available.

ONS-5010 would likely have significant pricing and reimbursement advantages, if approved. OTLK mgmt. has indicated that there is a wide pricing window that could leave ONS-5010 attractive from both competition and commercial opportunity standpoints. For reference, the price of QM Lucentis is ~$2k/injection while Eylea is comparable but at half the injection frequency in maintenance dosing, putting it more in line with Lucentis biosimilars yet still likely multiples higher than the price point Outlook will arrive at for ONS-5010. Although compounded bevacizumab is estimated to cost less than $100/injection, mgmt. estimates that the adjusted cost ends up closer to $1k/injection when switching is accounted for. OTLK’s conversations with payors representing over 270 million lives indicate a high degree of willingness to support a shift away from widespread use of compounded bevacizumab. Outside of payors, most doctors do not earn a profit by prescribing off-label bevacizumab. If OTLK's eventual pricing strategy can allow doctors to profit more from ONS-5010 vs. compounded bevacizumab, we think this could be an additional pull factor to opt for ONS-5010 rather than an off-label product.

Today, compounded bevacizumab is the reluctantly preferred 1L Tx for wAMD. ~70% of retinal specialists use compounded bevacizumab as a 1L regimen for their wAMD patients before proceeding to brand-name and biosimilar Tx options. This is largely owing to its attractive price point compared to other anti-VEGF therapies (~$55-$75 per injection vs. ~$2,000 for Eylea and Lucentis vs. ~$1,200 for biosimilar Lucentis) and well-established non-inferior efficacy vs. Lucentis. During a call we hosted last year with Dr. Szilard Kiss (recap HERE), he noted that despite the appeal on price and "equivalent efficacy" vs. ranibizumab (contended by Dr. Kiss), compounded bevacizumab leaves much to be desired, as there are prevailing concerns surrounding manufacturing quality with implications ranging from diminished efficacy to potentially life-changing adverse events (e.g., endophthalmitis).

[OGBritbox]

Professor Tim Jackson, PhD, FRCOphth, Consultant Ophthalmic Surgeon, King's College Hospital and Professor of Retinal Research, King’s College London, commented, “We have waited a long time for a brand of bevacizumab that is authorized for eye use, and it is good news that LYTENAVA™ has now entered the market. This occurs subsequent to Outlook Therapeutic's clinical trial meeting its endpoint. To date, many ophthalmologists have been hesitant to use an off-label bevacizumab, when licensed products are available. We value being able to utilize products that meet the standards required for marketing authorization. Additionally, a well-controlled pharmaceutical manufacturing operation will allay concerns that compounding pharmacies increase the risk of rare but potentially devastating endophthalmitis.

[exwannabe]

I certainly agree that out licensing the EU (in some form) is the way to go.

[thermo]

I don't want to minimize EU value. It's significant.

[thermo]

True, business value in the EU is not as attractive as the US. But you'd prefer to have it than not (positive NPV) and one's assessment of US probabilities should have shifted some post the EU decision. Outlicensing is the best move here.

[exwannabe]

EU launches are State by State and take a long time, Sometimes BP can use their resources to get it done "quickly", but still can be years for the entire market.

Nothing at all surprising to see an estimated 2025 for launches.

[H2R]

Hi Tex18,

Best is to listen to the latest presentation, available from here:
https://ir.outlooktherapeutics.com/news-and-events/event-calendar

For your question, start around minute 17 . In summary:
* Labeling
* Production ramp up / supply
* Pricing / Government discussions
* Access to payers / insurances / country by country

They might be able to start during the holiday period (might), but they prefer not to launch during that time.

Best of luck with your investments!

[Tex18]

Thermo, Board,

Any thoughts on why the launch in EU is delayed till 2025? Seems a touch excessively long. Would think Q4 be more reasonable to begin a slow ramp/onboard.

Is it simply to gain approvals in individual member states and/or ramp supply? Or is it something else like education/adoption?

Regards in advance.

[Mionaer1]

Thanks Thermo.

[thermo]

Revenues exceeding $2 Billion are possible. It's consistent with the aspirational numbers I've heard from some of the management (not guidance or a forecast, just what's possible).

I use $500 Million currently and that's all I need to own the stock at this point. If the US launch goes well, expectations will rise easily.

[Mionaer1]

Your calculation is plausible. Termo's sales estimate of $500M seems rather conservative to me based on Russ Trenary's statements.

[thermo]

OMG, are we friends again?

[exwannabe]

Thanks.

[thermo]

Norse 8 powering is 95%.

I'm less familiar with the EU as well. Even though the company is talking (and planning) for EU launch, it's more likely they out license, in my view.

[H2R]

Aspirational revenue of $2.5B

The following is a simple back of the envelope estimate of aspirational revenue and MC.

Russ Trenary clearly stated the market OTLK is after all current off-label bevacizumab injections in the EU and the US. He provided the following numbers.
* 3.5M injections in the US
* 2.8M injections in the EU

He also gave us a few clues on the pricing over a few presentations
My guess is that it will end up around
* $500 in the US
* $300 in the EU

So the top possible revenue (in a few years, after FDA approval, etc.) would be:

 
 * 300 * 2.8M for the EU = $0.84B 
 * 500 * 3.5M for the US = $1.75B 
                           ===== 
 * Total Possible Revenue: $2.59B		 
 

Typical biotechs valuations go around 10 times revenue. I don't think that would be the case here.
Let's say it's 4 times.

The aspirational market cap in the full possible market capture would be greater than $10B.

Say they only achieve half of that market: $5B MC.
Today, the MC is below $200M. 25 times the MC in say 4 years.

You can play on the price per injections and the % of the bevacizumab off-label injections OTLK will capture.
The number of off-label injections is now a known entity: we can use that as a solid estimation data point.
The moral of this exercise is that the upside can be very large over the medium term.

Best of luck with your investments!

[exwannabe]

Simple thesis to US approval (EU already in hand): known therapeutic profile + SPA

Agreed. There is still some chance of trial failure on pure bad luck. I have not seen the powering assumptions, but if powered at 85-90% then there is a 10-15% chance of S*** happens. Other than that, hard to see what can go wrong for the FDA.

Then one needs to develop a view on revenue, which is also a fairly simple exercise since we know that off label bevacizumab is widely used and, if an approved product is available, regulations prohibit the use of an off-label product*.

Tell that to AMRN longs

I do think it does well in the US though for obvious reasons. If I was a patient I would certainly prefer the FDA approved version to one some chemist put together in the back room. And for insurance companies, a no brainer to prefer it over the high priced VEGFs,.

Not sure about EU. I admit I do not know enough about those markets (as it is country by country), but do know that pricing issues can be messy.

[H2R]

Norse 8 Current Planning:
* Full enrollment Q3 2024
* Topline Q4 2024

Last month, enrollment was at 30%, so on track.

Russ Trenary during the June 18th investor presentation!

https://ir.outlooktherapeutics.com/news-and-events/event-calendar

[H2R]

UK: in the next month or 2

Could have a decision from the UK on ONS-5010 in the next 30-60 days
Russ Trenary during the June 18th investor presentation!

https://ir.outlooktherapeutics.com/news-and-events/event-calendar

[H2R]

"Ringing the cash register in Europe in 2025" [Russ Trenary during the June 18th investor presentation]

Q1 2025: launch in high pricing countries to set the tone on pricing for other countries, then expand to more EU countries throughout 2025.

OTLK is targeting the entire current Avastin injections, so about 3 million / year in EU and about the same in the US. That's the goal; I had not heard it this clearly thus far.

Payors in the US are looking at the overall cost when starting with off-label and switching to high priced treatments and compare it with ONS-5010 is patients stay on it. That's of interest to payors.



https://ir.outlooktherapeutics.com/news-and-events/event-calendar

[H2R]

And now 60 recruiting sites (out of 60 planned!)

The latest (last?) one is Oakland, California, United States, 94611

The investor's presentation, slide 18, indicates OTLK was planning on 60 recruiting sites:

400 treatment naïve, wet AMD subjects to be
enrolled at 60 US sites

https://ir.outlooktherapeutics.com/static-files/2cfae876-3be2-46cb-aa75-aca673544481

The update to cliniclaltrials does not change the estimated dates, which indicates the planning is being kept:
* Study Start2024-01-24 [Actual]
* Primary Completion2024-09 [Estimated]
* Study Completion2024-10 [Estimated]

OTLK continues to execute on their plan.

Best of luck with your investments!

The 60 sites:

Arcadia, California, United States, 91006
Bakersfield, California, United States, 93309
Beverly Hills, California, United States, 90210
Huntington Beach, California, United States, 92647
Laguna Hills, California, United States, 92653
Long Beach, California, United States, 90807
Modesto, California, United States, 95356
Oakland, California, United States, 94611
Pasadena, California, United States, 91107
Poway, California, United States, 92064
Sacramento, California, United States, 95841
Colorado Springs, Colorado, United States, 80909
Lakewood, Colorado, United States, 80228
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Stuart, Florida, United States, 34994
Oak Forest, Illinois, United States, 60452
Oak Park, Illinois, United States, 03440
Lenexa, Kansas, United States, 66215
Lexington, Kentucky, United States, 40509
Hagerstown, Maryland, United States, 21740
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Teaneck, New Jersey, United States, 07666
Albuquerque, New Mexico, United States, 87109
Liverpool, New York, United States, 13088
Oceanside, New York, United States, 11572
Rochester, New York, United States, 14620
Westbury, New York, United States, 11590
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Wake Forest, North Carolina, United States, 27587
Winston-Salem, North Carolina, United States, 27103
Edmond, Oklahoma, United States, 73013
Charleston, South Carolina, United States, 29414
Florence, South Carolina, United States, 29501
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Rapid City, South Dakota, United States, 57701
Germantown, Tennessee, United States, 38138
Abilene, Texas, United States, 79606
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Beaumont, Texas, United States, 77707
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75231
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78240
San Antonio, Texas, United States, 78251
The Woodlands, Texas, United States, 77384
Willow Park, Texas, United States, 79606
Salt Lake City, Utah, United States, 84107
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Bellevue, Washington, United States, 98004
Silverdale, Washington, United States, 98383

[H2R]

June 13, 2924 Seeking Alpha Article

Conclusion:

Making money by investing in clinical stage biotechs is notoriously difficult. No matter how good you may view the setup, unexpected hiccups often seem to arise.

In order to make out you have to do well enough on your winners to pay off your losers. I am pegging Outlook with its paltry <$200 million market cap and its chance to share a meaningful chunk of a $15.9 billion market as one of those potential big time winners. I am rating it a strong buy.

Best of luck with your investments!

[H2R]

June 18th webcast

Live video webcast on Tuesday, June 18th at 12:00 PM ET

ISELIN, N.J., June 11, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the commercialization and development of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, today announced that it will present at the Virtual Investor Pitch Conference on June 18, 2024 at 12:00 PM ET.

As part of the event, Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, will provide an “elevator pitch” and outline the Company’s upcoming milestones. Additionally, investors and interested parties will have the opportunity to submit questions live during the event. Participating companies will answer as many questions as possible in the time allowed.

A live video webcast of the presentation will be available on the Events page of the Investors section of the Outlook Therapeutics website (outlooktherapeutics.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

Best of luck with your investments!

[H2R]

Thanks Thermo,

I've liked your projections and the details on Reddit from another poster.

* https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173887120
* https://www.reddit.com/r/OTLK_Investors/comments/18sfaok/otlkbuyout_my_view_of_profits_at_december_22_2023

I'm a bit cagey when it comes to revenue projections, payors, price point, etc. On my side, I see a significant upside given the current MC at less than $200M and I'm good with that. Even with Europe only, the MC should improve on launch/revenue/country by country, so I'm staying invested. It may take 'a while', which in the biotech world is longer than in other industries :)

Then there is the possibility of a buy out. That would not surprise me a bit.

I'm looking forward to read more of your insights. You are one of my favorite posters on IHub.

Have a great day!

Best of luck with your investments!

[thermo]

Good summary H2R. Simple thesis to US approval (EU already in hand): known therapeutic profile + SPA

Then one needs to develop a view on revenue, which is also a fairly simple exercise since we know that off label bevacizumab is widely used and, if an approved product is available, regulations prohibit the use of an off-label product*.


* there may be low usage, but it's a pretty strong deterrent.

[Zadie420]

Thanks for great detail explanation. Interesting FDA had CRL regarding the effectiveness of ONS-5010 but EU has approved this drug last month. This shows how corrupt FDA is.

[H2R]

Hi Zadie420,

After the CRL from the FDA last year, OTLK passed an SPA (semi binding agreement) with the FDA around Norse 8.
"A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)"

OTLK is planning on recruiting about 400 patients from 60 sites (that's why I'm tracking the site numbers) in order to achieve the powering of the study.

IF (a big IF, but really, that's what I'm expecting) Norse 8 is successful, OTLK will submit Norse 8 as the basis for approval of ONS-5010 in the US. This submittal has been and is still planned for the end of the year. (There is planning, then there is reality). Then it's up to the FDA to finally deliver an approval or reject it.

Now, OTLK has been accepted in Europe on the basis of previous trials (which to me should have been sufficient for the FDA as well. I think the FDA is not quite straight with OTLK, but that's my own take), and the 3 months Norse 8 should confirm that (again, my opinion).

So I'm tracking a couple of things on the US side:
* The number of recruiting sites: 59 for now, they may not need 60, but they planned on it, so maybe one more
* The change in status from Recruiting to another status, like "Active, not recruiting" which might indicate all 400 patients (or a bit more) have been enrolled.

On the status change milestone, you know that the trial has 3 more months to unfold, then data collection, etc., leading to submittal.

Best of luck with your investments!

[Zadie420]

H2R- I forgot what these sites for study? Is OTLK going after another indication

[H2R]

1 more site, so 59 sites now

* Oceanside, New York, United States, 11572

See: https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1#contacts-and-locations

They had planned for 60, again, not sure they'll need all, but that's 1 to go if so.

Minor good non-news: Even though the update is dated 5/30 or 6/3 depending on how you read it, the estimate dates remain the same:
* Study Start: January 24, 2024
* Primary Completion: September 2024 [Anticipated]
* Study Completion: October 2024 [Anticipated]

The current list of recruiting sites:

Arcadia, California, United States, 91006
Bakersfield, California, United States, 93309
Beverly Hills, California, United States, 90210
Huntington Beach, California, United States, 92647
Laguna Hills, California, United States, 92653
Long Beach, California, United States, 90807
Modesto, California, United States, 95356
Pasadena, California, United States, 91107
Poway, California, United States, 92064
Sacramento, California, United States, 95841
Colorado Springs, Colorado, United States, 80909
Lakewood, Colorado, United States, 80228
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Stuart, Florida, United States, 34994
Oak Forest, Illinois, United States, 60452
Oak Park, Illinois, United States, 03440
Lenexa, Kansas, United States, 66215
Lexington, Kentucky, United States, 40509
Hagerstown, Maryland, United States, 21740
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Teaneck, New Jersey, United States, 07666
Albuquerque, New Mexico, United States, 87109
Liverpool, New York, United States, 13088
Oceanside, New York, United States, 11572
Rochester, New York, United States, 14620
Westbury, New York, United States, 11590
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Wake Forest, North Carolina, United States, 27587
Winston-Salem, North Carolina, United States, 27103
Edmond, Oklahoma, United States, 73013
Charleston, South Carolina, United States, 29414
Florence, South Carolina, United States, 29501
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Rapid City, South Dakota, United States, 57701
Germantown, Tennessee, United States, 38138
Abilene, Texas, United States, 79606
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Beaumont, Texas, United States, 77707
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75231
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78240
San Antonio, Texas, United States, 78251
The Woodlands, Texas, United States, 77384
Willow Park, Texas, United States, 79606
Salt Lake City, Utah, United States, 84107
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Bellevue, Washington, United States, 98004
Silverdale, Washington, United States, 98383

Best of luck with your investments!

[OGBritbox]

Almost as if they want retail to sell.