alertmeipp
5 일 전
Re: RSV deal - ChatGPT - Part 2
Then it tried to tailor this further based on Enanta’s financials and strategic goals. Obviously, some mistakes in the response... but still think its response is quite good and does provide some values.
Enanta Pharmaceuticals (NASDAQ: ENTA) is a clinical-stage biotechnology company specializing in small molecule drugs for viral infections and liver diseases. As of February 15, 2025, ENTA's stock is trading at $7.14, with an intraday high of $7.64 and a low of $7.10.
In the fiscal first quarter ended December 31, 2024, Enanta reported a net loss of $30.5 million, reflecting its ongoing investments in research and development. The company maintains a strong cash position, with $250 million in cash and marketable securities, providing a runway for its clinical programs.
Strategically, Enanta is focused on advancing its pipeline in virology and immunology, with a particular emphasis on its Respiratory Syncytial Virus (RSV) program. The company aims to bring innovative treatments to market, addressing significant unmet medical needs.
Given Enanta's financial standing and strategic objectives, a partnership for its RSV program would likely involve:
- **Upfront Payment**: $50M–$100M, providing immediate capital to support ongoing R&D activities.
- **Milestone Payments**: Up to $500M, contingent on achieving specific developmental and regulatory milestones.
- **Royalties**: Tiered royalties ranging from 10% to 20% on net sales, ensuring long-term revenue sharing.
These terms would align with Enanta's goal of accelerating the development and commercialization of its RSV therapy while maintaining financial stability.
Then, I questioned why it lowered the upfront payment:
Why I Adjusted to $50M–$100M (More Realistic for Enanta)
Stock Price & Market Cap: Trading at $7.14/share, Enanta has a market cap below $200M, limiting its negotiating power.
Cash Position: $250M in cash provides some runway, but Enanta is burning ~$30M per quarter, so they might accept a lower upfront to secure a deal.
Recent Court Loss (vs. Pfizer): The patent invalidation for their hepatitis C drug may weaken their leverage in negotiations.
Competitive RSV Landscape: Big pharma (PFE, GSK, AZN, MRK, SNY) already has RSV vaccines/therapies, which could reduce urgency to partner with Enanta.
alertmeipp
5 일 전
Re: RSV deal - ChatGPT - Pretty impressive.
It suggests JNJ the most likely partnership - "Johnson & Johnson (JNJ) stands out as a potential partner. While JNJ has been involved in RSV vaccine development, there is limited information about their current RSV therapeutic pipeline, suggesting they might be interested in collaborating to strengthen their position in RSV treatments."
As to deal terms, it states the below:
If Enanta Pharmaceuticals (ENTA) were to partner with a major pharmaceutical company for its RSV program, the deal terms would likely follow a standard biotech licensing or co-development agreement. Based on industry norms and Enanta’s past deals, here’s what the terms might look like:
---
### **1. Upfront Payment**
- **Range**: $75M–$250M
- The upfront payment would depend on the strength of Enanta’s RSV data (Phase 2 results), the level of interest from multiple bidders, and whether a partner sees it as best-in-class.
---
### **2. Milestone Payments**
- **Regulatory Milestones**: $300M–$600M
- Example:
- $50M for the initiation of a **Phase 3 trial**
- $100M upon successful **completion of Phase 3**
- $150M for **FDA approval**
- Additional payouts for **EMA & other regulatory approvals**
- **Sales Milestones**: $500M–$1B
- Example:
- $100M if **annual sales exceed $500M**
- $250M if **annual sales exceed $1B**
- Additional tiers if sales surpass **$2B+**
---
### **3. Royalties on Net Sales**
- **Tiered Royalties**: 12%–22%
- Example:
- **12% on sales up to $500M**
- **16% on sales between $500M–$1B**
- **20%–22% on sales over $1B**
- This is in line with industry norms for small biotechs licensing out late-stage assets.
---
### **4. Co-Development / Co-Promotion (Optional)**
- If Enanta wants to retain some commercialization rights (e.g., **North America or EU**), they may negotiate **cost-sharing** for Phase 3, with a profit split (e.g., **50/50 or 60/40**).
- More likely, Enanta would **out-license the entire asset** due to its small size and limited commercial infrastructure.
---
### **5. Manufacturing & Supply Agreements**
- Enanta may **retain manufacturing rights** or grant exclusive supply agreements for royalty-bearing sales.
---
### **6. Option to Buyout**
- Some deals include an **M&A trigger**, allowing the partner to acquire Enanta at a premium (e.g., **2–3x the stock price**) if the RSV asset meets key milestones.
---
### **Example of Comparable Deals**
- **Pfizer–ReViral (2022)**: $525M acquisition for RSV assets
- **Merck–Molnupiravir (Ridgeback)**: Upfront + royalties structure
- **Gilead–Galapagos (2019)**: $3.95B upfront for a broad partnership
---
### **Final Valuation Estimate**
- **Total Deal Size**: $1B–$2.5B, assuming strong Phase 2 data
- **Upfront Cash**: $100M–$250M
- **Royalties**: 12%–22%
Would you like me to tailor this further based on Enanta’s financials and strategic goals?
dewophile
6 일 전
RSV seasonal patterns in peds and adults updated:
The current RSV season is on the downswing and clearly past peak so a few observations from the RSV-NET site https://www.cdc.gov/rsv/php/surveillance/rsv-net.html
1. Among all age groups last season hospitalization rates peaked at 4.3/100K persons on 12/28/2023. This year the peak was 3.9 per 100K on 1/4/2025. The AUCs (i.e. overall hospitalization burden due to RSV) appear on track to be slightly lower this year than last, but pretty close - just shifted a bit later overall. For comparison in the year prior to the pandemic 2019-2020 the burden was clearly lower looking at the curves (AUC), with a peak on 1/4/2020 of 2.6 per 100k persons.
*so overall RSV burden the last 2 years appears as high or higher than historical standards (the site only has data as far back as the 2018 season but it was a bit lower than 2019 even)
2. Among neonates and infants 0-6 months of age you can clearly see an effect of Mabs and maternal vaccines. The peak this year (which was a worse season than per-covid overall) was lower with peak hospitalization rate of 74.4 per 100k versus lst year's 136.9 per 100K, and 125 per 100K 2019 season
3. In infants 6 months to 1 year this beneficial effect is markedly attenuated - with peaks of 49.6 per 100k this year vs 67 per 100K last year, 50 per 100k 2019
4. in 1-2 year olds, this year was worse than last year with peak hospitalization of 47.7 per 100k versus 42 per 100k , so even though this season a bit milder overall you can start to see the upward shift in age for hospitalization rates due to kids getting first infections at older age. for comparison this figure was a lot lower prepandemic with a peak at 29.6. so while the last 2 seasons were worse than 2019, I don't know if that lone can account for the doubling in hospitalization rates
5. Similar patterns emerge if you look at hospitalization rates in 1-4 year olds
6. The overall peds hospitalization rates 0-4 year olds this year peaked at 29.9 vs 36.7 last year vs 24.9 in 2019, but the overall burden when eyeballing the curves and AUC seems narrower between this year and last, but certainly lower this year, and probably a bit lower year on year than the overall RSV hospitalization burden for all comers.
My take here is that neonates and young infants get hospitalized a bit more commonly than a first infection in a 1-2 year old, so despite the upward shift in age for first severe infection, the overall burden is *slightly lower overall in peds with the introduction of passive immunity for this population. **
Obviously studies that are sure to be forthcoming will shed more light but I figured I would share a quick real time glean on seasonal patterns.
For Adults:
1. >65 year olds had slightly higher peak hospitalization rates last year versus this year at 9.4 vs 8.7. It peaked at 4.2 in 2019-2020. Adult vaccines are simply not making headway into curbing the RSV disease burden which is consisten with the fact that only 10% or so of older adults got vaccinated so far (thank you ACIP and shame on you)
2. This last year RSV vaccines were universally recommended without a shared decision making for 75 yo and up, yet the hospitalization rates this year was a smidge higher than last year even peaking at 14.7 vs 14.5 per 100K persons. Again the effect of vaccines is simply not there
If you are curious what one of the vaccine makers thinks of the risk benefit of the RSV vaccine in older adults, here is a copy of response I recently got from GSK IR:
We believe in the overall clinical profile and benefits of Arexvy. The GBS signal is rare <10 cases per 1 million vaccinated. CDC analysis showed up to 15K hospitalisations and 2K deaths are prevented over 3 seasons per 1 million vaccinations in each of the ACIP recommended populations vs up to 18 cases of GBS per 1 million vaccinations
and yet
We have not assumed any cohort expansion (or revaccination) in our 2025 forecasts
All of this is to once again say the introduction of all the preventative measures for RSV have not had a material effect on either the peds or adult market opportunity for an antiviral IMO
** because in peds dosing is weight based, even with slightly overall lower disease burden in peds the commercial opportunity will not be affected as much as the gap in disease burden because older kid simply require more drug per course of treatment
alertmeipp
1 주 전
It's entirely possible that they are waiting for the initial bid or proposal to come in, possibly later this month. Insider buying before the bids come in should be fine since they have already publicly disclosed their plans to evaluate deals.
After that, there would be two more rounds before they select the final winner. They need to secure something soon, or I suspect many will vote against them in the annual meeting. On top, they have a competitor that is right behind them, seemingly willing to move as fast as possible.
I hope the exclusion of Phase 3 from their guidance signals their confidence in securing a deal soon.
dewophile
1 주 전
Thx DD
The other SEC filing out today is the 10K:
https://ir.enanta.com/sec-filings/sec-filing/10-q/0000950170-25-018810
The costs in our immunology programs increased by $2.5 million primarily due to the scale-up and IND-enabling activities related to our KIT program and the initiation of preclinical studies for our STAT6 program.
Other Programs
Other program costs decreased by $2.2 million primarily due to the completion of the discovery and optimization activities related to our STAT6 program.
So while the company talks about scale up and ind enabling activities for kit as a 2025 event, it definitely started in earnest last quarter (no surprise). what is a bit unclear to me is they are most definitely in the discovery and optimization phase for stat6, yet in the 10k they say this is at "completion". I think they mean the costs are shifted from "early discovery" to the new stat 6 line item, but it is also possible they are further along and sandbagging a bit.
The big drop in early discovery program costs which is most of the 2,2M cited suggests to me they are probably winding down very early discovery, and perhaps the 3rd immunology program to be announced later this year may be the last. No complaints here I mean 4.4M in the same quarter last year on other early discovery might not sound like much, but at a 100M MC cutting down on this 18M annual burn is welcome news
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