$LQDA deja vu all over again
Q2 done and we should have 4500 patient starts on over $180m revs.
salesforce on 30% steroids hitting the road
$1B fwd runrate by end of Q3
Whatchoo Gonna Do Brother? LFG!!
$LQDA 77.35 as I type
I have been investing in biotech since the 1990's.
LQDA has actually graduated into a commercial stage pharma in a niche.
Over that time I have been in many companies and watched others run up. Those runups looked like decent selling points.
Were they?
It depends on two factors. Valuation and buyouts.
LQDA is still cheap on a valuation basis. It is also a buyout stock.
Buyout stocks routinely run into the buyout becoming public. On a few occasions, I sold in those runs only to be disappointed when the stock jumped another 40% when the buyout was announced.
Those experiences have hardened my commitment to owning good stocks despite runs, until they get bought out.
I see no reason that LQDA should not get bought out. I can imagine that some of the potential bidders will want the patent case decided at the trial level before they buy the company.
$LQDA $5B in peak sales is 250k GTN x 20k patients
Market Size: PH 40k & PH-ILD 80k
Only requires a 17% penetration rate
Inhaled Treprostinil as a whole is 14k patients already including Tyvaso (10k)
We are capturing >100% of market growth. Over a 5 year churn period we should own all 14k.
Not including Oral and IV switching which is 10k & 4k respectively.
Capturing 40% of this market is another 6k. (40% of switches are oral today)
We get to 20k patients just by converting the existing mkt on current trajectory.
Then we include PH-ILD mkt growth say 20% addressable. Another 16k patients as a buffer if the above doesn’t work out. We got 36k all up.
Now apply a 4x peak sales premium to reflect scarcity and you have a $20B valuation or $200 a share
$OCUL $EYPT Marketing the Products
Durability Values:
I hold that Axpaxli is likely to receive a 12-month duration label from the FDA with approval in the summer of 2027.
(In SOL-1, 65.9% of AXPAXLI-treated patients maintained vision for 52 weeks.)
Eylea HD has a 5-month duration label.
(The language is: "up to every 20 weeks for patients with wet age-related macular degeneration . . . following one year of successful response based on visual and anatomic outcomes." This was based of a study in which 47% of patients reached 20 weeks without rescue injections.)
Duravyu by $EYPT could get a 6 month label. It is possible, the label is only 24 weeks based on their studies.
$EYPT has stated that their goal is a 6-month label. Could they convince the FDA to give them a 1-year label based on their phase 2 study? The phase 2 study used 2mg and 3mg dosing with 47% and 52% having 12-month durability. Yet, the phase 3 studies use a 2.7mg version and only looks at 24-week dosing. It seems quite unlikely that the FDA grants a label beyond 6 months given the dose change.
Marketing:
With a 12-month label, $OCUL can make marketing statements like: "With duration up to 1 year, Axpaxli now offers double the labeled durability of any comparable Wet AMD treatment . Clinical studies have found that it is superior to Eylea 2mg in measures of disease control."
Imagine you were given the task of writing ads and other marketing materials for Duravyu in this context as it has come to market up against Axpaxli.
Maybe you write: "Our studies show we are just as effective as Eylea 2mg. Your doctor probably wants to see you every 6 months, so 6 months is long enough."
(All of this presumes that Duravyu gets strong results from their phase 3 studies.)
The Case Could Get Stronger:
The marketing statements for Axpaxli have the potential to get even stronger as more study results are available. They may be able to claim superiority over Eylea HD. They may have data to show how well Axpaxli protects against fibrosis and atrophy.
The Bottom Line
Axpaxli and Duravyu might be fairly similar drugs, yet the data supporting these drugs is quite different. $OCUL took more risks in their study designs. They made innovative changes to studies while preserving a SPA with the FDA.
Before these changes and outcomes, it was reasonable to conclude that the Wet AMD market is a big one and there was room for both products. The marketing challenges for Duravyu are now a huge issue.
Based on the current stock prices for $OCUL and $EYPT, the market has not recognized the changes to the Wet AMD market. My view is that this presents an opportunity.
(There are other issues beyond marketing for Duravyu with this kind of Axpaxli advantage. The primary one is that it can be more difficult to get payer coverage. Also, payers who offer approval may require significantly lower pricing.)
It is reasonable to assume that $EYPT could conduct a study establishing 1-year durability. The time required to recruit and conduct the study and submit to the FDA would mean adding about 2 years to the timeline. That could mean a 3-year head start for Axpaxli. How do you entice doctors to prefer Duravyu if they have 3 years of experience using Axpaxli? There would need to strong evidence that Duravyu is better.
@JialiangLiang@zipjet That's the whole point. You want to prove that ax works for six months and more while hd does not. Patients benefit from effective less frequent treatment/doc visits.
@SamENole Its idiotic. GD motive makes for more attractive football. Leagues that employ it vs h2h are more fun to watch. Best league in the world -Premier-, GD. Infantino has been a disaster. From ad breaks to 5 subs, he'll leave no wine in the water.