Replies to post #202006 on Biotech Values

[linhdtu]

It's a buying op lol. all that is needed is patience and guts .

i set my limits too low last nite, so i bought at 4K at 14 this morning

[DewDiligence]

RVNC will start two phase-3 trials of RT002 in glabellar lines during 2016:

http://investors.revance.com/releasedetail.cfm?ReleaseID=979658

Revance Therapeutics, Inc…today announced the completion of its Type B / pre-IND / pre-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) regarding DaxibotulinumtoxinA for Injection (RT002) for the treatment of glabellar (frown) lines. Based upon the discussion with the FDA and the minutes received following the meeting, Revance is moving forward with an Investigational New Drug (IND) submission for the Phase 3 clinical program for RT002 in glabellar lines and other supportive studies required for Biologics License Application (BLA) filing. Revance expects to initiate its Phase 3 clinical trials in the second half of 2016.

The company's Phase 3 program will include two placebo-controlled pivotal studies conducted at multiple sites in the US and Canada.

The primary endpoint of these studies will be a composite of the proportion of subjects who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity on investigator assessment (IGS-FWS) and patient assessment (PFWS) scales, at maximum contraction (frown), at Week 4. [Emphasis added.]

Duration of the reduction of severity of the glabellar lines will be assessed as a secondary endpoint in the Phase 3 pivotal studies. In addition, the Phase 3 program will include a long-term, open-label safety study. Revance plans to announce additional details on the study designs when the company begins dosing patients.

All of the above—including the open-label safety study—is consistent with prior expectations.

[DewDiligence]

Ipsen reports €$76M 2Q16 Dysport sales, +6% YoY:

http://finance.yahoo.com/news/ipsen-first-half-2016-results-050000679.html

[DewDiligence]

RVNC:

Added2 $RVNC today.

— Roy Friedman (@DewDiligence) August 3, 2016

[Bickema]

and the later is marketed by a small private company (Merz) who doesn't have what it takes to compete effectively.

Hey Dew, why hasn't a larger player with the necessary resources stepped in an acquired Merz?

P.S. started a small position today at 13.99, thank you for all your work

[DewDiligence]

RVNC closed +10.5% on no news I’m aware of.

(A dirt-cheap valuation can be a strong catalyst in its own right.)

[DewDiligence]

RVNC addendum re RT002 pricing (in reply to a question on another board):

There are no pricing considerations in (#msg-123290722). Do we know if… the cost expected to manufacture the product is similar to that of Botox?

Manufacturing cost is a very low (<10%) proportion of the price of Botox and other commercial botulinum toxins, so whatever difference there might be between RT002 and Botox in manufacturing cost is immaterial in the overall scheme of things.

On pricing, I expect RT002 to sell at a par with Botox if RT002 ends up getting a label with a slightly longer duration of action than Botox in certain indications. If RT002’s label is essentially the same as Botox’s with respect to duration of action, I expect RT002 will sell at a 10-15% discount to Botox in order to counter Botox’s strong brand awareness.

[DewDiligence]

Added RVNC today @$12.90-13.10 (eom).

[DewDiligence]

RVNC +20%. Will Trump's use of Botox increase male participation in the botulinum-toxin market?

Currently, the cosmetic portion* of the worldwide botulinum-toxin market is overwhelmingly female.

*The cosmetic portion of the market is about 45% of the total (#msg-126265588).

[marthambles]

RVNC - if Xeomin is non-inferior to Botox, why hasn't an acquirer emerged? Why hasn't the commercial opportunity been recognized by a pharmaceutical firm with the capability to properly market it and make it a worthy competitor? Given the size of the market, it would seem like a slam dunk.

[DewDiligence]

RVNC +63% since US presidential election (eom).

[DewDiligence]

Cover story of Time—>good for RVNC:

Replace "botox" by "botulinum toxin"...good story4 $RVNC: https://t.co/jqgSwDMCgE

— Roy Friedman (@DewDiligence) January 5, 2017

http://time.com/4623409/botox-drug-treating-everything

[DewDiligence]

(RVNC)—Global botulinum-toxin market to reach $7.3B in 2025, says market-research firm:

http://finance.yahoo.com/news/global-botulinum-toxin-market-size-100000839.html

I think they’re actually a little on the low side given the double-digit growth rate and the strong demographic tailwind (see bold-faced portion of #msg-123290722).

[DewDiligence]

Quiz: On RVNC’s 4Q16 CC, the CEO was asked how confident RVNC is in its CMC expertise, given that “peers have faltered in that section.”

Which company was the questioner referring to? (Hint: The answer has nothing to do with Copaxone.)

[DewDiligence]

(RVNC)—US spending on cosmetic surgery and non-invasive cosmetic procedures grew 11% YoY in 2016:

http://www.reuters.com/article/us-usa-plasticsurgery-idUSKBN16M3B1