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As used in this Current Report on Form 8-K, or this current report, Revance Therapeutics, Revance, the Company,
we, us and our refer to Revance Therapeutics, Inc., a Delaware corporation, and its subsidiaries on a consolidated basis. This current report includes trademarks, service marks and trade names owned by us or other
companies. All trademarks, service marks and trade names included in this current report are the property of their respective owners.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This current report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that
involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this current report, including statements regarding our future financial condition, business strategy and plans and objectives of
management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as believe, will, may, estimate, continue,
anticipate, intend, should, plan, expect, predict, could, potentially or the negative of these terms or other similar expressions. We have based these
forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These
forward-looking statements include, but are not limited to, statements concerning the following:
These forward-looking statements are subject to a number of risks, uncertainties and assumptions
described under the section titled Risk Factors and elsewhere in this current report and our filings with the SEC. We also operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not
possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or
implied by, any forward-looking statements. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances described in this current report and our other filings with the SEC may not occur and actual results
could differ materially and adversely from those anticipated or implied in the forward-looking statements contained in this current report.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in
the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur. These
forward-looking statements represent our estimates and assumptions only as of the date of the document containing the applicable statement. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for
any reason to conform these statements to actual results or to changes in our expectations.
You should read this current report and our
filings with the SEC with the understanding that our actual future results, levels of activity, performance and achievements may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary
OUR COMPANY AND RECENT DEVELOPMENTS
Revance Therapeutics, Inc. is a clinical-stage specialty biopharmaceutical company focused on the development, manufacturing, and
commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic indications. We are leveraging our proprietary portfolio of botulinum toxin type A compounds, combined with our patented TransMTS peptide delivery system, to address unmet needs in large and growing neurotoxin markets. Our proprietary TransMTS technology enables delivery of botulinum toxin type A through two investigational
drug product candidates, RT001, also referred to as RTT150 (Botulinum Toxin Type A) Topical Gel, and RT002, or RTT150 (Botulinum Toxin Type A) for Injection. We are pursuing clinical development for RT001 and RT002 in a broad spectrum of aesthetic
and therapeutic indications. We hold worldwide rights for all indications of RT001, RT002, and our TransMTS technology platform.
has the potential to be the first commercially available non-injectable dosage form of botulinum toxin type A. We are studying RT001 for aesthetic indications, such as crow s feet (wrinkles around the eyes, also known as lateral canthal lines),
and therapeutic indications, such as hyperhidrosis (excessive sweating). RT002 is a novel, injectable formulation of botulinum toxin type A designed to be a targeted and long-lasting injectable botulinum toxin type product. We are studying
injectable RT002 for aesthetic indications, such as glabellar (frown) lines, and therapeutic uses, such as muscle movement disorders, including cervical dystonia. Both products may have the potential to expand into additional aesthetic and
therapeutic indications in the future.
We are developing RT002, an injectable formulation of botulinum toxin type A, for indications where deep delivery of the botulinum toxin is
required and a long-lasting effect is desired. We believe RT002 may provide targeted delivery of botulinum toxin to intended treatment sites, while reducing the unwanted spread of botulinum toxin to adjacent areas. We believe, and our preclinical
and clinical studies indicate, that this targeted delivery, enabled by our proprietary peptide technology, may permit safe administration of higher doses of botulinum toxin and may result in long-lasting effect. We have demonstrated these properties
in preclinical studies and have tested RT002 in a four-cohort, dose escalating, open-label Phase 1/2 clinical trial outside of the United States for the treatment of glabellar lines, the vertical lines between the eyebrows and above the nose. Data
from this clinical trial indicated that RT002 appears to be well tolerated and met efficacy endpoints at all four doses. We also reported duration of effect of seven months from the last cohort of this trial, the only cohort for which duration of
effect was measured. Based upon the results to date, we are further developing RT002 for the treatment of glabellar lines and reported interim results from BELMONT, a Phase 2 active comparator clinical trial against the market leader BOTOX Cosmetic, on October 29, 2015.
The ongoing BELMONT trial involves treatment for glabellar lines in 268 subjects at nine
investigational sites in Canada. The trial compares the safety, efficacy and duration of effect of three doses of RT002 against placebo and current market leader, BOTOX Cosmetic/VISTABEL in a
randomized 1:1:1:1:1 trial design. A total of 77 subjects were excluded from the per protocol population across all cohorts in accordance with the trial protocol. The topline interim data from the trial showed that RT002 achieved its primary
efficacy measurement at four weeks for all doses of RT002. The study demonstrated six-month RT002 median duration of effect based upon at least 1-point improvement in glabellar lines at maximum frown on the Investigator Global Assessment-Facial
Wrinkle Severity, or IGA-FWS, scale. The four week primary efficacy measurement of at least 1-point improvement in glabellar lines based on the IGA-FWS scale for all three doses (20 Units, 40 Units and 60 Units) of RT002 was highly statistically
significant (p<0.001) as compared to placebo for all three doses. All doses of RT002 achieved a 100 percent response rate of at least 1-point improvement in glabellar lines, based on the IGA-FWS scale, at four weeks versus a 95 percent response
rate for BOTOX Cosmetic. In the trial, RT002 40U achieved statistically significant six-month duration of effect. Additionally, RT002 40U was statistically significant in duration compared to BOTOX Cosmetic for all definitions on the IGA-FWS scale
by both Intent to Treat, or ITT, and Per Protocol, or PP, populations. RT002 40U also achieved statistical significance compared to BOTOX Cosmetic on all three responder definitions for the IGA-FWS median duration of effect. On the IGA-FWS duration
of response, RT002 demonstrated a 23.6-week median duration versus BOTOX Cosmetic with an 18.8-week median duration (p=0.020). More than twice as many subjects receiving 40 Units and 60 Units of RT002 in the study maintained none or mild wrinkles on
the IGA-FWS scale, as compared to BOTOX Cosmetic at Week 16 (p 0.002). Outcomes reported by subjects were consistent with investigator findings of duration and efficacy of RT002. Across all cohorts, RT002
appeared to be generally safe and well tolerated. Adverse events were generally mild, localized and transient. No subjects receiving two of the doses evaluated, 20 Units and 40 Units of RT002, experienced ptosis (eyelid droop). There were no serious
adverse events or evidence of any systemic exposure at any of the three doses evaluated. We plan to report final results from our BELMONT trial and conduct an End-of-Phase 2 meeting with the United States Food and Drug Administration, or FDA, in the
first half of 2016. We then expect to begin Phase 3 clinical studies of RT002 for the treatment of glabellar lines in the second half of 2016.
Botulinum toxin treatment of glabellar lines is the largest proportion of cosmetic neurotoxin sales in the United States and, according to the
American Society for Aesthetic Plastic Surgery, botulinum toxin treatment is the number one nonsurgical cosmetic procedure in the United States. We believe RT002 has the potential to satisfy significant unmet needs in this market. According to
market research we conducted in April 2015, which involved a quantitative study with eighty dermatologists and plastic surgeons, 60% of the physicians surveyed stated that longer duration is a significant unmet need in the market for the botulinum
toxin treatment of glabellar lines and 75% stated that they are likely or very likely to use RT002 based on both injectable data available during the study and the RT002 product concept.
We have also initiated a Phase 2 dose-escalating, open-label clinical study of RT002 in the therapeutic indication of cervical dystonia, an
indication for which botulinum toxin is already approved as a treatment. The Phase 2 study will evaluate safety, preliminary efficacy, and duration of effect of RT002 for injection in subjects with moderate-to-severe isolated cervical dystonia
symptoms of the neck. We expect to release interim results in 2016. The category of muscle movement disorders, which includes cervical dystonia, accounted for approximately half of the estimated $1.8 billion neurotoxin therapeutic sales globally in
We are developing and plan to commercialize RT001 for indications where topical application provides a meaningful advantage over injectable
administration. RT001 is designed to have primary advantages, which include painless topical administration, no bruising, ease of use and limited dependence on administration technique by physicians and medical staff. We believe these potential
advantages may improve the experience of patients undergoing botulinum toxin procedures and make RT001 suitable for multiple indications.
The first indications we are pursuing are in the fields of dermatology and plastic surgery. If approved, we believe RT001 can expand the
overall botulinum toxin aesthetic market by appealing to new patients who would prefer a needle-free approach to treatment. The aesthetic dermatology market is attractive because we believe that patients in this market tend to be open to trying new
products and are willing to pay for aesthetic procedures out of pocket, reducing reliance on reimbursement. We are focused on this market not only because of its size and growth potential but also because, in the United States and Europe, this
market can be easily accessed by a specialty sales force and distributor network.
We are in a Phase 3 development program of RT001 in
North America for the treatment of crow s feet. During the third quarter of 2015, we initiated REALISE 1, a pivotal Phase 3 clinical trial designed to evaluate the safety and efficacy of a single, bilateral administration of RT001 topical gel
compared to placebo in subjects with moderate to severe crow s feet. We expect to report efficacy data from this study in the first half of 2016. To date, we have conducted seventeen clinical trials with RT001 for the treatment of crow s
feet, with a total of over 1,600 subjects. In two of our Phase 2b clinical trials, RT001 demonstrated a statistically significant and clinically meaningful reduction in crow s feet visible to both physicians and subjects. After completing our
Phase 2b clinical trials, we modified the formulation of the RT001 diluent. We then conducted a Phase 3 clinical trial with this new diluent formulation to evaluate the efficacy and safety of RT001. Data generated from this clinical trial were
inconsistent with the data from our previous three Phase 2b clinical trials for the treatment of crow s feet. Specifically, we observed no improvement from baseline in either the placebo or RT001 group. We initiated two open-label studies to
further assess our RT001 investigational topical drug product candidate. Following analysis of the data available from these open-label studies, taken together with our analysis of prior studies and early data from newly developed clinical methods,
we decided to proceed with a RT001 U.S. Phase 3 clinical trial for the treatment of crow s feet. Our clinical and other studies have consistently indicated that RT001 appears to be well tolerated with no serious adverse events related to the
study drug or study treatment procedures or other safety concerns.
We are also developing RT001 for therapeutic applications where
botulinum toxin has shown efficacy and that are particularly well suited for needle-free treatments. We have completed initial Phase 2 clinical trials for the treatment of primary axillary, or underarm, hyperhidrosis, and for the prevention of
chronic migraine headache. In the third quarter of 2015, we initiated an additional randomized, double-blinded, dose-ranging, placebo-controlled Phase 2 clinical trial designed to evaluate the safety and efficacy of a single, bilateral application
of RT001 Topical Gel for the treatment of primary axillary hyperhidrosis and expect to report interim results later in the fourth quarter of 2015.
Since commencing operations in 2002, we have devoted substantially all our efforts to identifying and developing product candidates for the
aesthetic and therapeutic markets, recruiting personnel and raising capital. We have devoted predominantly all of our resources to the preclinical and clinical development of, and manufacturing capabilities for, RT001 and RT002. We have retained all
rights to develop and commercialize RT001 and RT002 worldwide. We have not filed for approval with the FDA for the commercialization of RT001 or RT002 and we have not generated any revenue from product sales for RT001 or RT002.
As of September 30, 2015, we had cash, cash equivalents, and investments of $144.2 million.
Through September 30, 2015, we have funded substantially all of our operations through the sale and issuance of our common stock, preferred stock, venture debt and convertible debt. In March 2015, we entered into an At-The-Market, or ATM, sales
agreement, or the ATM agreement, with Cowen and Company, LLC, or Cowen, under which we may offer and sell our common stock having aggregate proceeds of up to $50.0 million from time to time. As of September 30, 2015, we sold 352,544 shares of
our common stock under the ATM agreement at a weighted average price of $30.76 per share, resulting in net proceeds of approximately $10.1 million, after underwriting discounts, commissions and other offering expenses. On June 19, 2014, we
completed a follow-on public offering, pursuant to which we issued 4,600,000 shares of common stock at $30.50 per share, including the exercise of the underwriters option to purchase 600,000 additional shares of common stock, for net proceeds
of $131.3 million, after underwriting discounts, commissions and other offering expenses. On February 6, 2014, we completed our initial public offering, or IPO, for sale of 6,900,000 shares of common stock at $16.00 per share, including the
exercise of the underwriters option to purchase an additional 900,000 shares of common stock, for net proceeds of $98.6 million, after underwriting discounts, commissions and other offering expenses. We also raised $23.7 million through the
issuance of convertible notes in the fourth quarter of 2013 and January 2014.
On October 31, 2015, we entered into a separation agreement
with Arthur P. Bertolino, M.D., Ph.D., our Chief Medical Officer and Executive Vice President, pursuant to which he resigned his employment with the Company, effective as of December 31, 2015, to pursue opportunities outside of the Company. Dr.
Bertolino was previously granted options to purchase an aggregate of 152,570 shares of the Company s common stock and restricted stock awards for an aggregate of 45,453 shares. In connection with the separation and transition, the Company
agreed to accelerate the vesting of a portion of his outstanding equity awards. If he remains employed with the Company through November 15, 2015, then his option grants and restricted stock awards will have vested with respect to an aggregate
of 76,286 shares and 23,740 shares, respectively. If he remains employed with the Company through December 31, 2015, then his option grants and restricted stock awards will have vested with respect to an aggregate of 114,428 shares and 35,610
shares, respectively. Dr. Bertolino will not be entitled to cash severance payments in connection with his departure. The terms of the separation agreement further provide for a general release and other customary provisions.
Our Corporate Information
incorporated in Delaware in August 1999 under the name Essentia Biosystems, Inc. We commenced operations in June 2002 and, in April 2005, changed our name to Revance Therapeutics, Inc. Our principal executive offices are located at 7555 Gateway
Boulevard, Newark, California 94560, and our telephone number is (510) 742-3400. Our website address is www.revance.com. The information contained in, or that can be accessed through, our website is not part of this current report.
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012. As an emerging growth company we
are eligible for exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the
Sarbanes-Oxley Act of 2002 and reduced disclosure obligations regarding executive compensation. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the
closing of our initial public offering in February 2014, (b) in which we have total annual gross revenue of at least $1.0 billion or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common