Revance Therapeutics Inc [NASDAQ: RVNC]

[Michael Scally MD]

Revance Therapeutics Inc [NASDAQ: RVNC]
RVNC : Summary for Revance Therapeutics, Inc. - Yahoo Finance

Revance Announces Ground-Breaking Data Presentations at Leading International Neurotoxin Conference
Revance Announces Ground-Breaking Data Presentations at Leading International Neurotoxin Conference | Revance Therapeutics, Inc.

· Revance’s long-acting neuromodulator RT002, along with its unique proprietary peptide and formulation technology, will be featured in 11 podium and poster presentations at the TOXINS 2019 conference in Denmark -

Revance Announces Proposed Public Offering of Common Stock
Revance Announces Proposed Public Offering of Common Stock | Revance Therapeutics, Inc.

NEWARK, Calif.--(BUSINESS WIRE)--Jan. 15, 2019-- Revance Therapeutics, Inc. (Nasdaq:RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions (“Revance” or the “Company”), today announced a proposed underwritten public offering in which it will issue and sell approximately $100 million of shares of its common stock. Revance expects that the underwriters will be granted a 30-day option to purchase from the Company up to an additional 15% of the shares of its common stock.

The Company intends to use the net proceeds received from its offering of common stock for working capital and general corporate purposes, including clinical trial and related expenses, research and development expenses, general and administrative expenses, and capital investments. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Goldman Sachs & Co. LLC, Cowen and Piper Jaffray are acting as book-running managers for the proposed offering.

 

[Michael Scally MD]

RVNC sells 6.76M* shares @$17—a 15.8% discount to Tuesday’s close:
Revance Announces Pricing of Public Offering of Common Stock | Revance Therapeutics, Inc.

The fully-diluted share count* is now 48.0M, up from 41.2, an increase of 16.5%.

RVNC’s pro forma cash balance* is now about $300M, which is enough to comfortably cover operating expenses through the expected RT002 launch in 1H20, given the expected slowdown in R&D spending following the completion of the (very expensive) SAKURA-3 study.

The offering’s discount of 15.8% (relative to Tuesday’s close) is on the high side for a company of RVNC’s stature, so it’s reasonable to surmise that the execution could’ve been better; however, this offering is certainly not a deal-breaker for the investment thesis.

To the contrary, RVNC’s enterprise value (based on today’s anticipated price range) is barely more than $500M, which I would characterize as dirt cheap for a company that has completed phase-3 trials with a large, blemish-free dataset and has a product candidate that is very likely to become the best-in-class treatment in a rapidly expanding global market for both aesthetic and therapeutic indications.

*Assuming exercise of $15M underwriter’s option.

 

[Michael Scally MD]

Revance risk/reward attractive into RT002 launch, says Piper Jaffray
Revance risk/reward attractive into RT002 launch, says Piper Jaffray RVNC - The Fly

Revance Therapeutics has enough cash to commercialize RT002 in the aesthetics setting following last week's capital raise, Piper Jaffray analyst David Amsellem tells investors in a research note. The company will be launching RT002 into a "consumer-focused, promotion-intensive landscape where it will be up against a well-entrenched competitor," adds the analyst.

However, Amsellem continues to believe that the body of data surrounding RT002 in glabellar lines points to the product gaining a "significant foothold." He believes peak sales for RT002 could be well in excess of $1B, making for an attractive risk/reward profile on shares of Revance. The analyst reiterates an Overweight rating on the stock with a $50 price target.

 

[Michael Scally MD]

(RVNC) — 4Q18 worldwide Botox sales=$945.9M, +12% YoY (+7.5% QoQ*):
http://phx.corporate-ir.net/Externa...yfFBhcmVudElEPTUyNzcwMDh8Q2hpbGRJRD03MDM1MTE=

• US therapeutic: $433.3M (+13 YoY)
• US cosmetic: $258.1.0M (+13% YoY)
• Ex-US therapeutic: $96.7 (+7 YoY in constant currency)
• Ex-US cosmetic: $157.8M (+9% YoY in constant currency)

All told, 73% of Botox sales were in the US, where the therapeutic/cosmetic split was 63/37; 27% of Botox sales were ex-US, where the therapeutic/cosmetic split was 38/62.


*The large 4Q18 increase relative to 3Q18 was expected; Botox is seasonally stronger in the second and fourth quarters of the calendar year.

 

[Michael Scally MD]

RVNC- Wellington Management Group LLP discloses 11.66% ownership in RVNC / Revance Therapeutics, Inc.
SEC Filing | Revance Therapeutics, Inc.


Wellington Management Group LLP
Home | Wellington Management

 

[Michael Scally MD]

Revance Releases Fourth Quarter and Full Year 2018 Results
Revance Releases Fourth Quarter and Full Year 2018 Results | Revance Therapeutics, Inc.
SEC Filing | Revance Therapeutics, Inc.

NEWARK, Calif., February 26, 2019 - Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions, today announced results for the fourth quarter and full year ended December 31, 2018 and provided a business update.

Recent Highlights for DaxibotulinumtoxinA for Injection (DAXI) and Upcoming Company Milestones

• DAXI demonstrated unprecedented efficacy and duration in alleviating moderate-to-severe glabellar (frown) lines in the SAKURA 3 Phase 3 open-label, long-term safety study. DAXI consistently produced long duration and high response rates and was well tolerated in over 3,800 treatments.
• Completed a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) in December of 2018, and is on-track to submit a Biologics Licensing Application (BLA) in the first half of 2019 for DAXI for the treatment of glabellar (frown) lines.
• Initiated two separate Phase 2 trials of DAXI for the management of plantar fasciitis, and for the treatment of adult upper limb spasticity. Expects to complete enrollment for both Phase 2 trials and its Phase 3 trial for cervical dystonia during the second half of 2019.
• Announced license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. to commercialize DAXI in mainland China, Hong Kong and Macau. Received upfront payment of $30 million, and is eligible to receive additional development and sales milestone payments, as well as tiered double-digit royalty payments on future net sales.
• Revance and Mylan recently had a Biosimilar Initial Advisory Meeting with the FDA on a proposed biosimilar to BOTOX®. In this meeting, the FDA provided guidance on their expectations for a development program to establish biosimilarity to BOTOX®. Based on the agency’s feedback, the companies believe that a 351(k) pathway for the development of a biosimilar to onabotulinumtoxinA is viable and provides the opportunity to develop and commercialize a biosimilar product for all 11 currently approved indications of BOTOX® and BOTOX® Cosmetic.

“The unprecedented results from our SAKURA Phase 3 trials for DAXI supplied us a with comprehensive data package for our BLA submission and provides a powerful springboard for our anticipated product launch to treat frown lines in 2020. Based on our unique peptide technology, only Revance is able to deliver the first true innovation in a neuromodulator by addressing the number one unmet need desired by physicians and patients alike -- longer duration,” said Dan Browne, president and chief executive officer at Revance. “We are taking steps to address the largest segments of the estimated $4.5 billion global neuromodulator opportunity and believe we can expand this fast-growing market by attracting new users and generating new approved uses. In facial aesthetics, we are commencing additional studies in the upper face, adding to our robust clinical data set. In therapeutics, we are advancing a sizable neuroscience pipeline. The combination of our DAXI long-acting and the biosimilar short-acting formulations uniquely position Revance to significantly expand the use of neuromodulators.”

Summary Financial Results

Cash, cash equivalents and short-term investments as of December 31, 2018 were $175.8 million. The same balance as of January 31, 2019 was $295.5 million, including the upfront payment from the Fosun license agreement and the net proceeds from the recent public stock offering.

 

[Michael Scally MD]

Why You Should Be Watching Revance Therapeutics
Why You Should Be Watching Revance Therapeutics - Allergan plc (NYSE:AGN) | Seeking Alpha

Summary
· Over the past couple of months Allergan's Botox injection has come under pressure.
· Evolus just obtained FDA approval within the month, and Revance seems to be in hot pursuit.
· Evolus has a large molecule the may be able to take cosmetic market share from Allergan, but Revance is positioning to gouge therapeutic and cosmetic share.
· Revance's RT002 (DAXI) promises longer time between injections and potentially faster onset with greater symptomatic reduction in movement disorders.
· By the end of FY-2019 Revance aims to submit RT002 for approval to treat frown lines, and finish enrollment of phase 2/3 studies for treatment of cervical dystonia.

 

[Michael Scally MD]

[RVNC] Botox Rivals Create New Wrinkles for Allergan
New pricing and new claims to longer-lasting effects from Botox competitors could entice beauty treatment customers to try something new
Botox Rivals Create New Wrinkles for Allergan

Allergan AGN 0.19% PLC’s multibillion-dollar Botox franchise is once again under attack from new competitors, threatening a core business at a time when the drugmaker is already battling other challenges.

The anti-wrinkle treatment, approved for cosmetic use in 2002, helped create an $8 billion-plus global market for beauty-enhancing drugs. Its ballooning sales propelled Allergan up the ranks of drugmakers. Botox’s world-wide sales of $3.6 billion last year contributed more than a fifth of Allergan’s total revenue.

Those sales are now at risk: A longstanding rival recently rejiggered its marketing to spur sales. A newly approved wrinkle treatment is expected to launch soon. And a third company is trying to develop its own frown-line therapy that lasts longer than Botox.

The volleys come at a challenging time for Allergan, whose shares have fallen about 40% since a recent peak in July 2017, partly because the company’s No. 2-selling product—a dry-eye drug called Restasis, with more than $1 billion in sales—is losing patent protection. Allergan has also faced a series of setbacks in new-drug development.

…

Dr. Waibel said she is using more Dysport because of attractive prices and is open to other options too. “Give me something that changes the game,” she said. “Give me something that lasts longer. Give me something like that, and I’m really excited.”

…

A bigger challenge, doctors and analysts say, could come from a longer-acting frown-line treatment under development. The drug Daxi maintained either none or only mild wrinkles in about a third of patients after about six months, according to a late-stage study sponsored by Revance Therapeutics Inc. That is longer than Botox’s claim of up to four months.

 

[Michael Scally MD]

Evolus ...

Rzany B-J, Denfeld R, Gross JE, et al. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects. 2019. Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

Background - PrabotulinumtoxinA is a 900 kDa botulinum toxin type A produced by Clostridium botulinum.

Objective - To investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines.

Methods - This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult subjects (n=540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (GLS, 0=no lines, 1=mild, 2=moderate, 3=severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Subjects were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n=245), 20 U onabotulinumtoxinA (n=246) or placebo (n=49). The primary efficacy endpoint was the proportion of responders (subjects with a GLS score of 0 or 1 at maximum frown by investigator assessment) on Day 30.

Results - Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4%; 95% CI (-1.9, 10.8). Given that the lower bound of the 95% CI for the difference was > -10.0%, non-inferiority of prabotulinumtoxinA versus onabotulinumtoxinA was concluded. Five subjects (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events; none were study-drug related.

Conclusion - A single treatment of 20 U prabotulinumtoxinA was safe and effective and non-inferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.

 

[Michael Scally MD]

Revance Appoints Former Allergan Marketing Veteran Taryn Conway as Vice President of Marketing
Revance Appoints Former Allergan Marketing Veteran Taryn Conway as Vice President of Marketing | Revance Therapeutics, Inc.

NEWARK, Calif.--(BUSINESS WIRE)--Apr. 9, 2019-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions, today announced a pivotal addition to its leadership team with the appointment of Taryn Conway as Vice President, Marketing, effective April 8, 2019. As the company transitions from clinical-stage development to commercialization, Ms. Conway will be an integral architect of product launch strategies and implementation, reporting to Head of Commercial - Aesthetics and Therapeutics, Dustin Sjuts.

“We’re thrilled that Taryn will be leading our marketing efforts as we approach the anticipated launch of our first-in-class, long-lasting neuromodulator, DaxibotulinumtoxinA for Injection (DAXI),” said Dustin Sjuts, Head of Commercial - Aesthetics and Therapeutics, for Revance. “Taryn is a highly experienced and talented marketer, who has expertise in building and developing billion-dollar brands with flawless execution across both the professional and consumer channels. Her competitive drive, innovative thinking and leadership skills will be the perfect addition to our growing commercial infrastructure.”

Ms. Conway is a leader in the global specialty pharmaceutical arena, with more than 20 years of marketing and commercial experience. She joins Revance from Allergan, Inc., where during her 16-year tenure, she held increasingly responsible roles in product and strategic marketing. She was most recently an Associate Vice President in Marketing, leading the creation and implementation of innovative product launch strategies to drive growth in a highly competitive marketplace. Ms. Conway holds a Bachelor of Arts in Law and Society from the University of California, Santa Barbara. She is an active advisory board member of the Healthcare Businesswomen’s Association in Orange County, California.

 

[Michael Scally MD]

Allergan 360° Aesthetics Report™ Reveals Evolving Beauty Perceptions and Diverse Priorities Around the World
Digital Boom and Millennials are Growing the Category, Wellness and Self-Care are New Key Drivers, Interest is in Eyes and Body Contouring [Dr. Sabrina Guillen-Fabi]
Allergan 360° Aesthetics Report™ Reveals Evolving Beauty Percep


SAKURA 3 Trial Results Presented on Podium at World’s Largest Medical Aesthetic Conference
SAKURA 3 Trial Results Presented on Podium at World’s Largest Medical Aesthetic Conference | Revance Therapeutics, Inc.

· Unprecedented clinical results for DaxibotulinumtoxinA for Injection (DAXI), Revance’s long-acting neuromodulator, were highlighted at the 17thAesthetics & Anti-Aging Medical World Congress in Monte-Carlo –

NEWARK, Calif.--(BUSINESS WIRE)--Apr. 8, 2019-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions, today announced podium and poster presentations of its SAKURA 3 Phase 3 open-label, long-term safety study of DaxibotulinumtoxinA for Injection (DAXI) for the treatment of glabellar (frown) lines at the 17th Aesthetics & Anti-Aging Medical World Congress (AMWC).

The leading international conference was held April 4 - 6 in Monte-Carlo, Monaco. SAKURA 3 was the culmination of the largest aesthetic clinical program of an aesthetic neuromodulator, which consistently demonstrated unprecedented efficacy, safety and duration across 65 sites and 3,800 treatments. The SAKURA 3 trial was specifically designed to evaluate the long-term safety of DAXI following both single and repeat treatment administration in adults 18 years of age and over.

“I was excited to present the SAKURA 3 study data on DAXI at the largest aesthetics meeting in the world, with more than 2,000 people in attendance,” said cosmetic dermatologic surgeon Sabrina Guillen-Fabi, MD, of Cosmetic Laser Dermatology in San Diego, Calif. “Colleagues were impressed with the consistent and predictable response rates, the safety profile and, most importantly, the duration of effect.”

SAKURA 3 Podium Presentation - Results of a large open-label safety study of DaxibotulinumtoxinA for Injection in glabellar lines (Session: Botulinum Toxin: From Fundamental to Expert Practice).
Presenter: Dr. Sabrina Guillen-Fabi

SAKURA 3 Poster Presentation - Results of a large open-label safety study of DaxibotulinumtoxinA for Injection in glabellar lines.
Sabrina Guillen-Fabi, MD, Jeremy B Green, MD, Yan Liu, Roman G Rubio, Conor J Gallagher

SAKURA 1 and 2 Pivotal Phase 3 Trial Poster Presentation - Pooled results from two Phase 3 pivotal studies of DaxibotulinumtoxinA for Injection in glabellar lines
Joely Kaufmann-Janette, MD, Nowell Solish, MD, Yan Liu, Roman G Rubio, Conor J Gallagher

"We were delighted to have Dr. Sabrina Guillen-Fabi share the exceptional results from the SAKURA 3 trial with a worldwide audience of aesthetic and anti-aging experts," said Dan Browne, president and chief executive officer at Revance. “We will continue to share these results at aesthetics conferences and through major medical journals while we await potential U.S. regulatory approval next year. Revance plans to launch DAXI as not only a premium product, but the first major innovation in neuromodulators in 30 years, delivering enduring frown line reduction with just two treatments a year.”

 

[Michael Scally MD]

Revance: A Wrinkle-Inducing Year Creates An Opportunity
https://seekingalpha.com/article/4275579-revance-wrinkle-inducing-year-creates-opportunity

Summary
· Revance's share price has been battered over the past year.
· While it's unclear if DAXI can be considered a long-acting formulation based on glabellar lines data alone, it does generate a durable response.
· Results in cervical dystonia lend credence to the long-acting claim as it seems to increase duration of response without increasing adverse events.
· A look into Revance's enterprise value seems to suggest that it has been heavily discounted.

…

Concluding Remarks

Although RVNC may have a unique product on its hands, it seems that it has fallen out of favor with the market. While the extended response duration in glabellar lines may not necessarily be unique, DAXI has been able to show strong positive results.

As such, while it may not have an advantage (e.g. extended labeling), at least it will not be disadvantaged. In contrast, its CD results do seem to suggest DAXI could be a long-acting formulation, as it appeared to have a long duration of response without compromising AEs.

Given that DAXI could be unique and is intended for both therapeutic and aesthetic indications, it seems that RVNC is undervalued, especially when we compare it against EOLS, which is bringing a Botox "me-too" to the market for aesthetics only.

Hopefully, a timely BLA filing and catalysts in 2020 will bring some life back to RVNC. Otherwise, it may spend some more time floundering around.

 

[Michael Scally MD]

RVNC 2Q19 results—6/30/19 cash=$241.9M:
Revance Reports Second Quarter 2019 Financial Results, Provides Corporate Update | Revance Therapeutics, Inc.

Guidance for the glabellar-lines BLA submission remains “fall 2019.”
2019 cash-burn guidance remains $148-158M.