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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?


To: Machaon who wrote (28490)3/9/1999 3:46:00 PM
From: Cheryl Galt  Read Replies (3) | Respond to of 32384
 
>> " ... however, the return of Targretin rights will now permit us to rapidly generate revenues from distribution agreements pending in territories in which we will not directly market Targretin in oncology and dermatology" said Ligand Chairman, President and CEO David E. Robinson. "We expect these opportunities plus potential milestone revenue from the second generation compounds will contribute to our march to profitability this year and next," he continued <<

Bob, I still think that the TOP sentence is a difficult one to decipher. So how can I hold Robinson to any particular meaning?
(And i do NOT think this confusion is intentional, or devious. In 25 years, I've seen too many hastily written, confusing corporate memos authored by nice, honest people to be surprised at seeing another one.)

While I have ZERO experience in sales and marketing, I tend to agree with Henry's interpretation of Sentence #1. Right NOW, Ligand gets some kind of fee paid to them by their distributors -- who will be selling (hopefully) the already-for-sale Ontak and Panretin gel. If the distributor thinks he'll eventually get to handle bigger quantities of merchandise because of Targretin, then Ligand might get a better deal right NOW on some current cut. Anyway, that's as good a guess as any.

THIS revenue, pieced together with any milestone revenue from partners is welcome -- until the Targretin thing comes together, hopefully before the $70m line of credit from Elan is spent.
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As to criticism that the *Company* has made over-optimistic claims, I don't really buy that. It's hard to keep separate in my head what Ligand has said (and when), and what we've said on our thread and heard sell-side and newsletter "analysts" say. (I myself have made two mistakes here -- that I'm aware of.)

As to Ligand making overly hopeful statements? Maybe in the fall of 1996 and 1997 (I've been reading the old press releases). But NOT lately, imo. "March toward profitability" is vague, says nothing except the direction. The only excitable claims lately have been for the PRE-clinical Targretin results -- any number of press releases about that, each saying essentially the same thing, but cumulatively creating a euphoric mood.

In the S8 that they filed with the SEC back in January, they completely re-wrote the LONG "disclaimer" section. I put it in one window, and the comparable section from the 3Q 10Q in another window, and scrolled.

The contents were parallel, but the S8 was a major re-write -- with some material removed and others added. The new version is clear, a terrific job of editing. (Every bit of muddled passive voice was excised, for example.) It was so clear, that I remember thinking, 'WOW they've protected themselves from any potential shareholders' suit!!' One of our regulars posted a message that we should read that S8, and was promptly told it was just boilerplate.

"... potential milestone revenue from the second generation compounds will contribute to our march to profitability this year and next," he continued."

This is hardly hype, unless we want to read optimism between the lines.
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>> "Targretin opportunities" to rapidly contribute towards 1999-2000 revenues. <<

I don't think Robinson or the press release said that.
The words are from two different sentences of the press release.
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I have to fix someone lunch.
Will look more at this sometime later.
(The hazzards of having kids ... <g>
They think i'm running a 24-hour deli ... )

Cheryl



To: Machaon who wrote (28490)3/9/1999 4:28:00 PM
From: Cheryl Galt  Respond to of 32384
 
Back from the ranch ... Questions, no answers ...

You ask << can we "expect" significant and positive Targretin announcements shortly? <<
----------------------

First, i sure hope that many of the 180 women get their lives extended in reasonably comfortable fashion. That is what the multi-arm trial is all about. The trial *design* looks *terrific* to me (an amateur <g>). And we shall see ...

Targretin worked terrific in rats. We're BETTING on this;
but it's the big positive UNKNOWN in our risk/reward equation.
----------------------

As to SPEED of feedback to us, well, it IS Open Labeled, and that helps.
But, in order to guess what to "expect" ...

Lets all look at how fast we've gotten feedback from OTHER trials. Let's go through some press releases, and jot down dates of trial initiation and first interim results.
I did that. Learned a lot.
---------------

As to THIS trial:

On 11/23/98 Ligand announced the protocol for a 3-arm, open-label Ph II multi-center study.

In observing Ligand and other biotechs for over two years, what have WE learned about how long it takes centers to get going on such studies? (They generally have monthly planning meetings, to work out clinic assignment and schedules, strategize for doing accruals... )

How long does it take to accrue 180 patients that fit three specific arms, and meet other protocal criteria?

How long does it take to PUBLICIZE the patient requirements -- get the protocol listed in NIH's PDQ database and/or other such databases? How long after that can they get the patients, have them consult with their doctors, fill out the consent forms, evaluate the returned forms, med-check the patients to see if they fit the criteria?
(Keep in mind that TWO new drugs for ABC came out in 1998 -- Herceptin and Xeloda -- so that all eligible patients may not spring for this trial.)

Then the test starts, and the patients take their first pills.
The November press release said, "All patients will be evaluated every eight weeks for the first six months of the study and every 12 weeks thereafter"
(Does this sound like at least a one-year study?)

**IF** they got going TODAY, we might hear word of 6-month results on August 9th -- unless they need time to evaluate the 6-months of data -- coming from *multiple* centers -- before doing a press release.
--------------------

After 2 years of watching biotechs, I have an altered understanding of the meaning of "rapid progress." In other words, I now have realistic expectations, and other people's euphoria washes right over, so that I rarely feel disappointed or sense any "delay."
--------------------

Regards,
Cheryl

PS - I hope my writing doesn't have an "edge" to it.
If so, kindly excuse.
I'm sorting this stuff out, and going fast, because I have to leave soon, for a class,
AND I still have to get supper going. That darn 24-hour deli ... <G>
Everybody's on a different schedule these days ...
And they think I'm June Cleaver. Where'd they get THAT idea ???




To: Machaon who wrote (28490)3/9/1999 4:56:00 PM
From: Cheryl Galt  Read Replies (1) | Respond to of 32384
 
I emailed two main questions to IR on March first,
At that time, Pam Wallace immediately responded,
"I have forwarded questions 2 and 3 to the office of Dr. Steven Reich, Senior Vice President, Clinical Research."
----------------

Here's my Question #3:

Ligand has said they plan to file an NDA application for Targretin for CTCL
early this year.

o Is that still the plan?
o Has the FDA granted Ligand Orphan Drug status for Targretin for CTCL?

I checked the FDA's list of Orphan Drug designates at fda.gov
and Targretin was not on the list.

o Is this an oversight on the part of the FDA?
---------------------

Today, Ms Wallace responded:

"We plan to file Targretin capsules for CTCl in the first part of this year.
We do not at this time have Orphan Drug Status."

---------------------

Had I been phoning, I'd have asked if they expected to file for it, or if they expected instead, to try to get expedited handling of Targretin for ABC.

If any of you phone IR, please ask.

Cheryl



To: Machaon who wrote (28490)3/9/1999 7:10:00 PM
From: Cheryl Galt  Respond to of 32384
 
Here's my Question #2 to IR:

I am very interested in your Phase II trial of Targretin for advanced breast cancer.

I've looked for announcements of this trial protocol
- in NIH's PDQ database - cancernet.nci.nih.gov
- at CenterWatch - centerwatch.com
- and at NABCO's List of BC trials - nabco.org
So far nothing has turned up in those places (although I did see a reference to it at the U of Virginia).

o Are you planning to announce the trial in any of the above databases?
o Do you have a list of centers that are conducting the test?
o How is accrual coming along?
o Is it progressing well in all three arms?
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Response from IR:

The breast cancer study will be posted on PDQ only.

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That's all I've got, except that Ms Wallace also said,

"Our earnings release date will be in the last week of March.
No definite date yet."
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