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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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77-0551645
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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7555 Gateway Boulevard
Newark, California 94560
(510) 742-3400
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
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Title of Each Class
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Name of Exchange on Which Registered
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Common Stock, par value $0.001 per share
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The NASDAQ Stock Market LLC
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Large accelerated filer
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¨
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Accelerated filer
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¨
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Non-accelerated filer
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x
(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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Page
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Item 1
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Item 1A
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Item 1B
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Item 2
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Item 3
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Item 4
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Item 5
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Item 6
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Item 7
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Item 7A
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Item 8
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Item 9
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Item 9A
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Item 9B
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Item 10
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Item 11
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Item 12
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Item 13
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Item 14
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Item 15
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•
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our expectations regarding the results and the timing of clinical trials in our development of DaxibotulinumtoxinA Topical Gel (RT001), or RT001 topical, for the treatment of crow’s feet, hyperhidrosis or other indications;
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our expectations regarding the results and the timing of clinical trials of DaxibotulinumtoxinA for Injection (RT002), or RT002 injectable, for the treatment of glabellar lines, cervical dystonia or other indications;
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our expectations regarding our future development of RT001 topical and RT002 injectable for other indications, including therapeutic indications;
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our expectation regarding the timing of our regulatory submissions for approval of RT001 topical for the treatment of crow’s feet, hyperhidrosis, and other indications in the United States, Europe and other countries;
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our expectation regarding the timing of our regulatory submissions for approval of RT002 injectable for the treatment of glabellar lines, cervical dystonia, and other indications in the United States, Europe and other countries;
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the potential for commercialization of RT001 topical and RT002 injectable, if approved, by us;
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our expectations regarding the potential market size, opportunity and growth potential for RT001 topical and RT002 injectable, if approved for commercial use;
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our belief that RT001 topical and RT002 injectable can expand the overall botulinum toxin market;
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our ability to build our own sales and marketing capabilities, or seek collaborative partners including distributors, to commercialize our product candidates, if approved;
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our ability to transfer manufacturing from third parties to our facility and to scale up our manufacturing capabilities;
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estimates of our expenses, future revenue, capital requirements and our needs for additional financing;
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the timing or likelihood of regulatory filings and approvals;
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our ability to advance product candidates into, and successfully complete, clinical trials;
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the implementation of our business model, strategic plans for our business, product candidates and technology;
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the initiation, timing, progress and results of future preclinical studies and clinical trials, and our research and development programs;
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
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our ability to establish collaborations or obtain additional funding on acceptable terms, if at all;
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our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act;
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our financial performance; and
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developments and projections relating to our competitors and our industry.
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ITEM 1.
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BUSINESS
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PIPELINE
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PRE-CLINICAL
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PHASE 1
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PHASE 2
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PHASE 3
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2016 PLANNED MILESTONES
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RT001 TOPICAL PRODUCT CANDIDATE
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Lateral Canthal Lines
(Crow’s Feet)
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Report US Phase 3 pivotal study efficacy results -1H 2016.
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Hyperhidrosis
(Excessive Sweating)
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Complete current Phase 2 study - 1H 2016.
Initiate additional Phase 2 study.
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Other Therapeutic Indications
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RT002 INJECTABLE PRODUCT CANDIDATE
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Glabellar (Frown) Lines
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Conduct End-of-Phase 2 Meeting with FDA - 1H 2016. Initiate Phase 3 program - 2H 2016.
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Cervical Dystonia
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Report interim Phase 2 study results - 1H 2016.
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Other Therapeutic Indications
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RT002 injectable may permit longer lasting effect of 6 months.
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RT002 injectable may provide targeted delivery of botulinum toxin to intended treatment sites while potentially reducing the unwanted spread of botulinum toxin to adjacent areas.
This could potentially decrease unwanted side effects like eyelid ptosis (droopy eyelids) and patient dissatisfaction.
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RT002 injectable may be simple to use and consistent with administration of currently available marketed products.
Minimal training is required because administration would be similar to currently available marketed products.
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RT002 injectable may lead to more sustained patient satisfaction between treatments, which is critical for self-pay procedures.
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RT002 injectable could potentially expand their practices by appealing to consumers (particularly men) who are not willing to come in multiple times per year to sustain the benefits of treatment.
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Physicians may be willing to pay more for RT002 injectable compared to currently available neurotoxins as they believe that they could easily pass that cost along to their patients, who would be willing to pay for increased duration of effect.
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In phase 2 studies, RT002 injectable appeared to be well-tolerated with no significant safety concerns.
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96% of subjects were rated with None or Mild wrinkle severity at maximum frown 4 weeks post-treatment using the GLSS as assessed by the clinical investigator.
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83% of subjects assessed themselves as achieving None or Mild wrinkles at maximum frown at the same time point.
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In the final cohort, the only one where duration of effect was measured, RT002 injectable achieved a median duration of 29.4 weeks or seven months based on both investigator and subject assessments.
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In this final cohort, 60% of subjects maintained None or Mild wrinkle severity at 6 months.
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RT002 injectable was well-tolerated, and there was no evidence of spread beyond the treatment site at any dose; additionally, adverse event rates did not change in frequency, severity, or type with increasing doses.
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The RT001 topical procedure is painless and has not shown any evidence of bruising, swelling or any of the other adverse events associated with injections
. The RT001 topical procedure consists of a clear gel applied to the skin, remaining on the skin for 30 minutes and then removed with a series of gentle cleansing wipes.
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RT001 topical relaxes the crow’s feet wrinkles appearance at “rest,” when the face is in a neutral expression, while still allowing a natural smile
. Data from our Phase 2b clinical trials indicate that RT001 topical improves the appearance of crow’s feet at rest. This improvement is visible to both the consumer and the physician. By targeting only the muscles necessary to achieve this effect, treatment with RT001 topical allows for natural expression at smile. In comparison, injection involves a broader array of muscles, which can lead to an unwanted frozen face appearance even at smile.
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Consumers distinguish between products that are injected into the body and those that are placed on the skin
. Of the participants surveyed in consumer market research performed by a third party on our behalf in 2012, a majority of those who responded that they have not received injectable botulinum toxin treatments in the past but who did find the RT001 topical product concept appealing, listed their aversion to needles as the reason why they have not previously tried the injectable botulinum toxin treatments. The responses in this survey, including open-ended questions, suggest that 63% of consumers in the group surveyed are more likely to use RT001 topical over injectable options.
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RT001 topical has been shown to be well-tolerated with no significant safety concerns
. There has been no report of the spread of botulinum toxin away from treatment site.
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RT001 topical is simple to use and results are not technique dependent. RT001 topical comes in a pre-filled applicator that contains the proper dose for the treatment of crow’s feet
. A physician or medical staff applies droplets of the gel from our pre-filled applicator to the treatment area and uses a gloved finger to ensure that the entire area is covered. In contrast, a great deal of physician skill is required to accurately and precisely inject current needle-based botulinum toxin products into smaller, more superficial muscles to achieve a natural looking appearance in the crow's feet area. According to our market research data collected by a third-party research organization in 2009 through internet-based surveys and interviews: 82% of the 204 physicians surveyed with existing cosmetic revenues said that they were either “extremely interested” or “very interested” in purchasing the RT001 topical product concept for use in their patients; and 76% of the 204 physicians surveyed mentioned the benefits of topical administration, including no need for needles and easy and convenient administration, as why they liked the RT001 topical product concept.
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RT001 topical is very appealing to both key physicians and practice groups who perform the majority of cosmetic procedures in the United States and physicians who have less injectable botulinum toxin experience
. We believe that RT001 topical can expand the use of botulinum toxin to a wider range of physicians and allow those physicians who currently perform botulinum toxin procedures to do so on a larger number of patients. RT001 topical can also improve the profitability of practices by increasing the number of procedures a given patient receives per visit. Importantly, this expansion can come without any increase in the number of patients that the physician has in their practice. In addition, because the RT001 topical procedure for the treatment of crow’s feet would be paid for directly by patients, consistent with current aesthetic treatments, physicians would not be encumbered by managed care and government payor reimbursement restrictions applicable in the United States and similar reimbursement-related constraints outside the United States.
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Over-the-counter antiperspirants (78%)
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Prescription antiperspirants (77%)
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Oral medication (53%)
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Botulinum Toxin Injections (41%)
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Iontophoresis, or the use of electrical current on skin (38%)
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Surgery (13%)
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Other (10%)
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The peptide backbone core is a sequence of consecutive lysine residues that are positively charged under physiologic conditions. The purpose of this positively charged core is to form a non-covalent (electrostatic) bond with the negatively charged macromolecule to be transported across the skin.
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The second part of the peptide is a Protein Transduction Domain, or PTD, which is responsible for delivering the macromolecule to the target site. There are two identical PTDs at each end of the peptide.
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hyperhidrosis;
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chronic migraine headache;
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urinary incontinence and overactive bladder;
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movement disorders, such as cervical dystonia and upper and lower limb spasticity; and
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uncontrolled blinking.
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Advance RT002 Injectable Clinical Development.
In the first half of 2016, we plan to complete the BELMONT Phase 2 active comparator against the market leader, BOTOX® Cosmetic, for the treatment of glabellar lines and have an End of Phase 2 meeting with the FDA. Following the End of Phase 2 meeting with the FDA, we plan to initiate a Phase 3 program in the second half of 2016. In muscle movement disorders, we plan to continue our Phase 2 trial for the treatment of cervical dystonia.
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Complete Development And Seek Regulatory Approval for RT001 Topical
. We are in the advanced stages of our development process of RT001 topical for the treatment of crow's feet. We expect to report results from the first of two U.S. Phase 3 pivotal clinical trials in the first half of 2016 and plan to initiate additional Phase 3 pivotal clinical trials in the United States and Europe subsequently. We expect to file for regulatory approvals for the treatment of crow's feet in the United States and Europe. We chose to focus on these markets not only because of their size and growth potential but also because, in the United States and Europe, the market can be easily accessed by a specialty sales force.
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Advance Future Therapeutic Indication for RT001 Topical
. We expect to initiate a second Phase 2 clinical study using RT001 topical for the treatment of axillary hyperhidrosis in the second half of 2016. In the future, we expect to continue developing RT001 topical for therapeutic indications where injection-based botulinum toxin dose forms are poorly tolerated, or have higher risk of adverse events. We believe that the commercial potential of RT001 topical in therapeutic indications could be substantial given the number of indications that we could pursue and the significant advantages of a painless, topical approach.
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Build Our Own Sales And Marketing Capabilities To Commercialize RT001 Topical and RT002 Injectable in North America.
If RT001 topical is approved
for the treatment of crow's feet or RT002 injectable is approved for the treatment of glabellar lines by the FDA, we intend to build our own sales force and commercial organization to launch in North America. Specifically, we plan to build a specialty sales force to target key physicians who perform the majority of aesthetic procedures, including dermatologists, plastic surgeons, facial plastic surgeons, and oculo-plastic surgeons.
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Expand The Global Market For Botulinum Toxin Products
. We believe RT001 topical can expand the overall botulinum toxin market beyond the current patient base by bringing in new patients who would prefer a needle-free approach to treatment and a more tolerable procedure. RT001 topical's profile may also make it preferable for aesthetic indications where the risk of toxin spreading to adjacent muscles can cause undesired outcomes such as bruising, droopy eye and unwanted frozen face. We believe RT002 injectable also has the ability to expand the botulinum toxin market by appealing to patients who seek a longer lasting effect.
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Establish Selective Strategic Partnerships To Maximize The Commercial Potential Of Our Product Candidates and TransMTS® Delivery Technology Platform
. Outside of North America, we plan to evaluate whether to
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Maximize The Value Of Our Botulinum Toxin Cell Line And Manufacturing Assets
. We have developed an integrated manufacturing, analytics, research and development facility that is capable of producing proprietary forms of botulinum toxin combined with TransMTS® peptide for Revance and any future partners.
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BOTOX
®
and BOTOX Cosmetic®, marketed by Allergan, Inc., since its original approval by the FDA in 1989, has been approved for multiple indications, including glabellar lines, crow’s feet, hyperhidrosis, upper and lower limb spasticity, cervical dystonia, strabismus, blepharospasm, chronic migraine, incontinence, and overactive bladder. In November 2015, Pfizer Inc. and Allergan entered into a merger agreement set to close in 2016. This creates a leading global pharmaceutical company with significant research, discovery, and delivery capabilities.
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Myobloc
®
, a neuromodulator currently marketed by US WorldMeds and approved by the FDA in 2000.
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Dysport
®
, an injectable botulinum toxin for the treatment of cervical dystonia, and glabellar lines and upper limb spasticity, which is marketed by Ipsen Ltd., or Ipsen, and Galderma, a Nestle company. Galderma acquired rights to market the product in the United States and Canada from Valeant Pharmaceuticals International, Inc. in 2014. Dysport® was approved by the FDA in 2009. Ipsen had previously received marketing authorization for a cosmetic indication for Dysport
®
in Germany in 2006 and, in 2007, Ipsen granted Galderma an exclusive
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Xeomin
®
, marketed by Merz Pharma, or Merz, and approved by the FDA in 2010 for cervical dystonia and blepharospasm in adults previously treated with Botox
®
. In the third quarter of 2011, Xeomin
®
was approved by the FDA and in Korea for glabellar lines. In the fourth quarter of 2015, Xeomin
®
was approved by the FDA for the treatment of upper limb spasticity. Xeomin
®
is also currently approved for therapeutic indications in most countries in the European Union as well as Canada and certain countries in Latin America and Asia. Bocouture
®
(rebranded from Xeomin
®
), marketed by Merz and received approval for glabellar lines in Germany in 2009. In 2010, Bocouture
®
was approved in significant markets within the European Union. Xeomin
®
is also approved for glabellar lines in Argentina and Mexico.
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completion of preclinical laboratory tests, animal studies and formulation studies performed in accordance with the FDA’s current good laboratory practices, or GLP, regulations;
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submission to the FDA of an IND which must become effective before human clinical trials in the United States may begin;
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approval by an institutional review board, or IRB, at each clinical trial site before each trial may be initiated;
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performance of adequate and well-controlled human clinical trials in accordance with the FDA’s current good clinical practices, or GCP, regulations to establish the safety and efficacy of the product candidate for its intended use;
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submission to the FDA of a BLA;
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satisfactory completion of an FDA inspection, if the FDA deems it as a requirement, of the manufacturing facility or facilities where the product is produced to assess compliance with the FDA’s current good manufacturing practice standards, or cGMP, regulations to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity, as well as compliance with applicable Quality System Regulations, or QSR, for devices;
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potential audits by the FDA of the nonclinical and clinical trial sites that generated the data in support of the BLA;
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potential review of the BLA by an external advisory committee to the FDA, whose recommendations are not binding on the FDA; and
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FDA review and approval of the BLA prior to any commercial marketing or sale.
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Phase 1.
The product candidate is initially introduced into a limited population of healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for some diseases, or when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients with the disease or condition for which the product candidate is intended to gain an early indication of its effectiveness.
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Phase 2.
The product candidate is evaluated in a limited patient population, but larger than in Phase 1, to identify possible adverse events and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted indications and to assess dosage tolerance, optimal dosage and dosing schedule.
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Phase 3.
Clinical trials are undertaken to further evaluate dosage, and provide substantial evidence of clinical efficacy and safety in an expanded patient population, such as several hundred to several thousand, at geographically dispersed clinical trial sites. Phase 3 clinical trials are typically conducted when Phase 2 clinical trials demonstrate that a dose range of the product candidate is effective and has an acceptable safety profile. These trials typically have at least 2 groups of patients who, in a blinded fashion, receive either the product or a placebo. Phase 3 clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of a BLA.
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ITEM 1A.
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RISK FACTORS
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timely completion of, or need to conduct additional, clinical trials, including our clinical trials for RT001 topical, RT002 injectable and any future product candidates, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the number and design of such trials and the accurate and satisfactory performance of third-party contractors;
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our ability to demonstrate the effectiveness and duration of effect of our products on a consistent basis as compared to existing or future therapies;
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our ability to demonstrate to the satisfaction of the FDA, the safety and efficacy of RT001 topical, RT002 injectable or any future product candidates through clinical trials;
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whether we are required by the FDA or other similar foreign regulatory agencies to conduct additional clinical trials to support the approval of RT001 topical, RT002 injectable or any future product candidates;
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the acceptance of parameters for regulatory approval, including our proposed indication, primary endpoint assessment and primary endpoint measurement relating to our lead indications of RT001 topical;
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our success in educating physicians and patients about the benefits, administration and use of RT001 topical, RT002 injectable or any future product candidates, if approved;
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the prevalence and severity of adverse events experienced with our product candidates or future approved products;
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the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;
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the ability to raise additional capital on acceptable terms and in the time frames necessary to achieve our goals;
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achieving and maintaining compliance with all regulatory requirements applicable to RT001 topical, RT002 injectable or any future product candidates or approved products;
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the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments;
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the effectiveness of our own or our future potential strategic collaborators’ marketing, sales and distribution strategy and operations;
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our ability to manufacture clinical trial supplies of RT001 topical, RT002 injectable or any future product candidates and to develop, validate and maintain a commercially viable manufacturing process that is compliant with current good manufacturing practices, or cGMP;
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our ability to successfully commercialize RT001 topical, RT002 injectable or any future product candidates, if approved for marketing and sale, whether alone or in collaboration with others;
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our ability to enforce our intellectual property rights in and to RT001 topical, RT002 injectable or any future product candidates;
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our ability to avoid third-party patent interference or intellectual property infringement claims;
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acceptance of RT001 topical, RT002 injectable or any future product candidates, if approved, as safe and effective by patients and the medical community; and
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the continued acceptable safety profile of RT001 topical, RT002 injectable or any future product candidates following approval.
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our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory body that RT001 topical, RT002 injectable or any future product candidates are safe and effective for the requested indication;
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the FDA’s or the applicable foreign regulatory agency’s disagreement with our trial protocol or the interpretation of data from preclinical studies or clinical trials;
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our inability to demonstrate that clinical and other benefits of RT001 topical, RT002 injectable or any future product candidates outweigh any safety or other perceived risks;
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the FDA’s or the applicable foreign regulatory agency’s requirement for additional preclinical or clinical studies;
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the FDA’s or the applicable foreign regulatory agency’s non-approval of the formulation, labeling or the specifications of RT001 topical, RT002 injectable or any future product candidates;
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the FDA’s or the applicable foreign regulatory agency’s failure to approve our manufacturing processes or facilities, or the manufacturing processes or facilities of third-party manufacturers with which we contract; or
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the potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval.
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the results of our clinical trials for RT001 topical and RT002 injectable;
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the timing of, and the costs involved in, obtaining regulatory approvals for RT001 topical, RT002 injectable or any future product candidates;
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the number and characteristics of any additional product candidates we develop or acquire;
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the scope, progress, results and costs of researching and developing RT001 topical, RT002 injectable or any future product candidates, and conducting preclinical and clinical trials;
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the cost of commercialization activities if RT001 topical, RT002 injectable or any future product candidates are approved for sale, including marketing, sales and distribution costs;
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the cost of manufacturing RT001 topical, RT002 injectable or any future product candidates and any products we successfully commercialize and maintaining our related facilities;
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our ability to establish and maintain strategic collaborations, licensing or other arrangements and the terms of and timing such arrangements;
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the degree and rate of market acceptance of any future approved products;
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the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments;
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any product liability or other lawsuits related to our products;
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the expenses needed to attract and retain skilled personnel;
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any litigation, including litigation costs and the outcome of such litigation;
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the costs associated with being a public company;
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the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and
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the timing, receipt and amount of sales of, or royalties on, future approved products, if any.
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the effectiveness and duration of effect of our product as compared to existing therapies;
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physician willingness to adopt a new therapy to treat crow’s feet, hyperhidrosis, glabellar lines, cervical dystonia or other aesthetic or therapeutic indications;
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overcoming any biases physicians or patients may have toward injectable procedures for the treatment of crow’s feet, hyperhidrosis or other indications;
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patient satisfaction with the results and administration of our product and overall treatment experience;
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patient demand for the treatment of crow’s feet, hyperhidrosis, glabellar lines, cervical dystonia or other aesthetic or therapeutic indications; and
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the revenue and profitability that our product will offer a physician as compared to alternative therapies.
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the safety and efficacy of the product as demonstrated in clinical trials;
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the clinical indications for which the product is approved;
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acceptance by physicians, major operators of clinics and patients of the product as a safe and effective treatment;
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proper training and administration of our products by physicians and medical staff;
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the potential and perceived advantages of our products over alternative treatments;
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the cost of treatment in relation to alternative treatments and willingness to pay for our products, if approved, on the part of physicians and patients;
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the willingness of patients to pay for RT001 topical, RT002 injectable and other aesthetic treatments in general, relative to other discretionary items, especially during economically challenging times;
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the willingness of third-party payors to reimburse physicians for RT001 topical, RT002 injectable and any future products we may commercialize;
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relative convenience and ease of administration;
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the prevalence and severity of adverse events; and
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the effectiveness of our sales and marketing efforts.
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obtain regulatory approval to commence a trial;
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reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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obtain institutional review board, or IRB, approval at each site;
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recruit suitable subjects to participate in a trial;
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have subjects complete a trial or return for post-treatment follow-up;
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ensure clinical sites observe trial protocol or continue to participate in a trial;
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address any patient safety concerns that arise during the course of a trial;
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address any conflicts with new or existing laws or regulations;
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add a sufficient number of clinical trial sites; or
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manufacture sufficient quantities of product candidate for use in clinical trials.
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the success of any sales and marketing programs that we, or any third parties we engage, undertake, and as to which we have limited experience;
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the extent to which physicians recommend RT001 topical or RT002 injectable to their patients;
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the extent to which RT001 topical or RT002 injectable satisfies patient expectations;
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our ability to properly train physicians in the use of RT001 topical or RT002 injectable such that their patients do not experience excessive discomfort during treatment or adverse side effects;
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the cost, safety and effectiveness of RT001 topical or RT002 injectable versus other aesthetic treatments;
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consumer sentiment about the benefits and risks of aesthetic procedures generally and RT001 topical or RT002 injectable in particular;
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the success of any direct-to-consumer marketing efforts we may initiate; and
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•
|
general consumer confidence, which may be impacted by economic and political conditions.
|
•
|
manage our clinical trials and manufacturing operations effectively;
|
•
|
identify, recruit, retain, incentivize and integrate additional employees;
|
•
|
manage our internal development efforts effectively while carrying out our contractual obligations to third parties; and
|
•
|
continue to improve our operational, financial and management controls, reporting systems and procedures.
|
•
|
decreased demand for RT001 topical, RT002 injectable or any future product candidates or products we develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants or cancellation of clinical trials;
|
•
|
costs to defend the related litigation;
|
•
|
a diversion of management’s time and our resources;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
•
|
loss of revenue; and
|
•
|
the inability to commercialize any products we develop.
|
•
|
the research methodology used may not be successful in identifying potential product candidates;
|
•
|
competitors may develop alternatives that render our product candidates obsolete or less attractive;
|
•
|
product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights;
|
•
|
a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
|
•
|
a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;
|
•
|
a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable; and
|
•
|
intellectual property rights of third parties may potentially block our entry into certain markets, or make such entry economically impracticable.
|
•
|
warning letters;
|
•
|
civil and criminal penalties;
|
•
|
injunctions;
|
•
|
withdrawal of approved products;
|
•
|
product seizure or detention;
|
•
|
product recalls;
|
•
|
total or partial suspension of production; and
|
•
|
refusal to approve pending BLAs or supplements to approved BLAs.
|
•
|
a product candidate may not be deemed safe, effective, pure or potent;
|
•
|
FDA officials may not find the data from preclinical studies and clinical trials sufficient;
|
•
|
the FDA might not approve our third-party manufacturers’ processes or facilities; or
|
•
|
the FDA may change its approval policies or adopt new regulations.
|
•
|
restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
|
•
|
fines, warning letters or holds on clinical trials;
|
•
|
refusal by the FDA to approve pending applications or supplements to approved applications filed by us or our strategic collaborators, or suspension or revocation of product license approvals;
|
•
|
product seizure or detention, or refusal to permit the import or export of products; and
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
changes to manufacturing methods;
|
•
|
recall, replacement, or discontinuance of one or more of our products; and
|
•
|
additional recordkeeping.
|
•
|
regulatory or legal developments in the United States and foreign countries;
|
•
|
results from or delays in clinical trials of our product candidates, including our Phase 3 clinical program for RT001 topical and our Phase 2 clinical program for RT002 injectable;
|
•
|
announcements of regulatory approval or disapproval of RT001 topical, RT002 injectable or any future product candidates;
|
•
|
FDA or other U.S. or foreign regulatory actions or guidance affecting us or our industry;
|
•
|
introductions and announcements of new products by us, any commercialization partners or our competitors, and the timing of these introductions and announcements;
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
announcements by us or our competitors of significant acquisitions, licenses, strategic partnerships, joint ventures or capital commitments;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors and issuance of securities analysts’ reports or recommendations;
|
•
|
quarterly variations in our results of operations or those of our future competitors;
|
•
|
changes in financial estimates or guidance, including our ability to meet our future revenue and operating profit or loss estimates or guidance;
|
•
|
sales of substantial amounts of our stock by insiders and large stockholders, or the expectation that such sales might occur;
|
•
|
general economic, industry and market conditions;
|
•
|
additions or departures of key personnel;
|
•
|
intellectual property, product liability or other litigation against us;
|
•
|
expiration or termination of our potential relationships with customers and strategic partners; and
|
•
|
other factors described in this “Risk Factors” section.
|
•
|
only one of our three classes of directors will be elected each year;
|
•
|
no cumulative voting in the election of directors;
|
•
|
the ability of our board of directors to issues shares of preferred stock and determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval;
|
•
|
the exclusive right of our board of directors to elect a director to fill a vacancy or newly created directorship;
|
•
|
stockholders will not be permitted to take actions by written consent;
|
•
|
stockholders cannot call a special meeting of stockholders;
|
•
|
stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings;
|
•
|
the ability of our board of directors, by a majority vote, to amend the bylaws; and
|
•
|
the requirement for the affirmative vote of at least 66 2/3% or more of the outstanding common stock to amend many of the provisions described above.
|
•
|
We will indemnify our directors and officers for serving us in those capacities, or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.
|
•
|
We may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law.
|
•
|
We are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
|
•
|
We will not be obligated pursuant to our amended and restated bylaws to indemnify a person with respect to proceedings initiated by that person against us or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce a right to indemnification.
|
•
|
The rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons.
|
•
|
We may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.
|
ITEM 1B.
|
UNRESOLVED STAFF COMMENTS
|
ITEM 2.
|
PROPERTIES
|
ITEM 3.
|
LEGAL PROCEEDINGS
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
ITEM 5.
|
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
|
|
High
|
|
Low
|
||||
2015
|
|
|
|
||||
First Quarter
|
$
|
21.35
|
|
|
$
|
14.10
|
|
Second Quarter
|
$
|
35.72
|
|
|
$
|
19.25
|
|
Third Quarter
|
$
|
33.71
|
|
|
$
|
24.82
|
|
Fourth Quarter
|
$
|
42.41
|
|
|
$
|
25.57
|
|
|
|
|
|
||||
2014
|
|
|
|
||||
First Quarter (from February 6, 2014 to March 31, 2014)
|
$
|
39.86
|
|
|
$
|
21.00
|
|
Second Quarter
|
$
|
36.98
|
|
|
$
|
25.06
|
|
Third Quarter
|
$
|
34.01
|
|
|
$
|
18.82
|
|
Fourth Quarter
|
$
|
21.14
|
|
|
$
|
14.02
|
|
Company/Index
|
2/6/2014
|
3/31/2014
|
6/30/2014
|
9/30/2014
|
12/31/2014
|
3/31/2015
|
6/30/2015
|
9/30/2015
|
12/31/2015
|
Revance Therapeutics, Inc.
|
$100.00
|
$117.32
|
$126.63
|
$71.99
|
$63.09
|
$77.21
|
$119.11
|
$110.84
|
$127.23
|
NASDAQ Biotechnology Index
|
$100.00
|
$99.80
|
$108.67
|
$115.72
|
$128.67
|
$145.74
|
$156.71
|
$128.61
|
$143.81
|
NASDAQ Composite Index
|
$100.00
|
$103.67
|
$109.18
|
$111.62
|
$117.98
|
$122.45
|
$124.94
|
$116.08
|
$126.20
|
ITEM 6.
|
SELECTED FINANCIAL DATA
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Consolidated Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue
|
$
|
300
|
|
|
$
|
383
|
|
|
$
|
617
|
|
|
$
|
717
|
|
|
$
|
557
|
|
Total operating expenses
|
$
|
72,617
|
|
|
$
|
52,433
|
|
|
$
|
38,842
|
|
|
$
|
43,903
|
|
|
$
|
28,290
|
|
Loss from operations
|
$
|
(72,317
|
)
|
|
$
|
(52,050
|
)
|
|
$
|
(38,225
|
)
|
|
$
|
(43,186
|
)
|
|
$
|
(27,738
|
)
|
Interest expense
|
$
|
(1,190
|
)
|
|
$
|
(10,672
|
)
|
|
$
|
(15,164
|
)
|
|
$
|
(28,959
|
)
|
|
$
|
(17,790
|
)
|
Net and comprehensive loss
|
$
|
(73,476
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
(52,448
|
)
|
|
$
|
(58,259
|
)
|
|
$
|
(44,863
|
)
|
Net income (loss) attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
(1)
|
$
|
(73,476
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
258
|
|
|
$
|
(58,259
|
)
|
|
$
|
(44,863
|
)
|
Diluted
(1)
|
$
|
(73,476
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
1,083
|
|
|
$
|
(58,259
|
)
|
|
$
|
(44,863
|
)
|
Net income (loss) per share attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
(1)
|
$
|
(3.02
|
)
|
|
$
|
(3.24
|
)
|
|
$
|
1.17
|
|
|
$
|
(290.48
|
)
|
|
$
|
(226.06
|
)
|
Diluted
(1)
|
$
|
(3.02
|
)
|
|
$
|
(3.24
|
)
|
|
$
|
1.05
|
|
|
$
|
(290.48
|
)
|
|
$
|
(226.06
|
)
|
Weighted-average number of shares used in computing net income (loss) per share attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
(1)
|
24,340,466
|
|
|
19,391,523
|
|
|
220,220
|
|
|
200,560
|
|
|
198,456
|
|
|||||
Diluted
(1)
|
24,340,466
|
|
|
19,391,523
|
|
|
1,029,150
|
|
|
200,560
|
|
|
198,456
|
|
(1)
|
Net income per share for all periods presented reflects the one-for-fifteen reverse stock split effected on February 3, 2014.
|
|
As of December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents
|
$
|
201,615
|
|
|
$
|
171,032
|
|
|
$
|
3,914
|
|
|
$
|
4,083
|
|
|
$
|
29,621
|
|
Working capital surplus (deficit)
|
$
|
241,926
|
|
|
$
|
162,495
|
|
|
$
|
(42,747
|
)
|
|
$
|
(112,530
|
)
|
|
$
|
21,264
|
|
Total assets
|
$
|
275,822
|
|
|
$
|
192,469
|
|
|
$
|
22,645
|
|
|
$
|
13,423
|
|
|
$
|
39,928
|
|
Capital lease, net of current portion
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5
|
|
|
$
|
944
|
|
Convertible notes, net of current portion
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
45,062
|
|
Note payable, net of current portion
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,632
|
|
|
$
|
10,995
|
|
|
$
|
18,430
|
|
Financing obligation, net of current portion
|
$
|
5,346
|
|
|
$
|
598
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Convertible preferred stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
123,982
|
|
|
$
|
95,433
|
|
|
$
|
95,433
|
|
Accumulated deficit
|
$
|
(332,273
|
)
|
|
$
|
(258,797
|
)
|
|
$
|
(195,880
|
)
|
|
$
|
(218,326
|
)
|
|
$
|
(160,067
|
)
|
ITEM 7.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
salaries and related expenses for personnel in research and development functions, including stock-based compensation;
|
•
|
expenses related to the initiation and completion of clinical trials for RT001 topical and RT002 injectable, including expenses related to production of clinical supplies;
|
•
|
fees paid to clinical consultants, clinical trial sites and vendors, including CROs in conjunction with implementing and monitoring our preclinical and clinical trials and acquiring and evaluating preclinical and clinical trial data, including all related fees, such as for investigator grants, patient screening fees, laboratory work and statistical compilation and analysis;
|
•
|
the fair value of technology rights reacquired as part of our settlement with Medicis, as discussed below;
|
•
|
other consulting fees paid to third parties;
|
•
|
expenses related to establishment of our own manufacturing facilities;
|
•
|
expenses related to license fees and milestone payments under in-licensing agreements;
|
•
|
expenses related to compliance with drug development regulatory requirements in the United States, the European Union and other foreign jurisdictions; and
|
•
|
depreciation and other allocated expenses.
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
Consolidated Statements of Operations Data:
|
|
|
|
|
|
||||||
Revenue
|
$
|
300
|
|
|
$
|
383
|
|
|
$
|
617
|
|
|
|
|
|
|
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
(1)
|
47,529
|
|
|
33,390
|
|
|
27,831
|
|
|||
General and administrative
(1)
|
25,088
|
|
|
19,043
|
|
|
11,011
|
|
|||
Total operating expenses
|
72,617
|
|
|
52,433
|
|
|
38,842
|
|
|||
Loss from operations
|
(72,317
|
)
|
|
(52,050
|
)
|
|
(38,225
|
)
|
|||
Interest income
|
231
|
|
|
44
|
|
|
2
|
|
|||
Interest expense
|
(1,190
|
)
|
|
(10,672
|
)
|
|
(15,164
|
)
|
|||
Change in fair value of derivative liabilities associated with convertible notes
|
—
|
|
|
4,032
|
|
|
2,660
|
|
|||
Change in fair value of derivative liabilities associated with the Medicis settlement
|
127
|
|
|
(320
|
)
|
|
47
|
|
|||
Change in fair value of common stock warrant liability
|
—
|
|
|
(2,151
|
)
|
|
(621
|
)
|
|||
Change in fair value of convertible preferred stock warrant liability
|
—
|
|
|
(210
|
)
|
|
(743
|
)
|
|||
Loss on settlement of preferred stock warrant
|
—
|
|
|
(1,356
|
)
|
|
—
|
|
|||
Other income (expense), net
|
(327
|
)
|
|
(234
|
)
|
|
(404
|
)
|
|||
Loss before income taxes
|
(73,476
|
)
|
|
(62,917
|
)
|
|
(52,448
|
)
|
|||
Benefit from income taxes
|
—
|
|
|
—
|
|
|
—
|
|
|||
Net loss
|
$
|
(73,476
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
(52,448
|
)
|
Unrealized loss on available for sale securities
|
(40
|
)
|
|
—
|
|
|
—
|
|
|||
Comprehensive loss
|
(73,516
|
)
|
|
(62,917
|
)
|
|
(52,448
|
)
|
|
(1)
|
Results above include stock-based compensation as follows:
|
|
Year Ended
December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
(In thousands)
|
||||||||||
Stock-Based Compensation:
|
|
|
|
|
|
||||||
Research and development
|
$
|
6,511
|
|
|
$
|
2,357
|
|
|
$
|
194
|
|
General and administrative
|
5,877
|
|
|
4,173
|
|
|
354
|
|
|||
Total stock-based compensation
|
$
|
12,388
|
|
|
$
|
6,530
|
|
|
$
|
548
|
|
|
Years Ended December 31,
|
|
2015 vs. 2014
|
|
2014 vs. 2013
|
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
%
|
|
%
|
||||||||
|
(In thousands, except percentages)
|
||||||||||||||||
Relastin Product
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
150
|
|
|
N/A
|
|
|
(100
|
)%
|
Relastin Royalty
|
300
|
|
|
300
|
|
|
300
|
|
|
—
|
%
|
|
—
|
%
|
|||
License
|
—
|
|
|
83
|
|
|
167
|
|
|
(100
|
)%
|
|
(50
|
)%
|
|||
Total revenue
|
$
|
300
|
|
|
$
|
383
|
|
|
$
|
617
|
|
|
(22
|
)%
|
|
(38
|
)%
|
|
Year Ended December 31,
|
|
2015 vs. 2014
|
|
2014 vs. 2013
|
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
%
|
|
%
|
||||||||
|
(In thousands, except percentages)
|
||||||||||||||||
Research and development
|
$
|
47,529
|
|
|
$
|
33,390
|
|
|
$
|
27,831
|
|
|
42
|
%
|
|
20
|
%
|
General and administrative
|
25,088
|
|
|
19,043
|
|
|
11,011
|
|
|
32
|
%
|
|
73
|
%
|
|||
Total operating expenses
|
$
|
72,617
|
|
|
$
|
52,433
|
|
|
$
|
38,842
|
|
|
38
|
%
|
|
35
|
%
|
|
Years Ended December 31,
|
|
2015 vs. 2014
|
|
2014 vs. 2013
|
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
%
|
|
%
|
||||||||
|
(In thousands, except percentages)
|
||||||||||||||||
Interest income
|
$
|
231
|
|
|
$
|
44
|
|
|
$
|
2
|
|
|
425
|
%
|
|
2,100
|
%
|
Interest expense
|
(1,190
|
)
|
|
(10,672
|
)
|
|
(15,164
|
)
|
|
(89
|
)%
|
|
(30
|
)%
|
|||
Change in fair value of derivative liabilities associated with convertible notes
|
—
|
|
|
4,032
|
|
|
2,660
|
|
|
(100
|
)%
|
|
52
|
%
|
|||
Change in fair value of derivative liabilities associated with the Medicis settlement
|
127
|
|
|
(320
|
)
|
|
47
|
|
|
(140
|
)%
|
|
(781
|
)%
|
|||
Change in fair value of common stock warrant liability
|
—
|
|
|
(2,151
|
)
|
|
(621
|
)
|
|
(100
|
)%
|
|
246
|
%
|
|||
Change in fair value of convertible preferred stock warrant liability
|
—
|
|
|
(210
|
)
|
|
(743
|
)
|
|
(100
|
)%
|
|
(72
|
)%
|
|||
Loss on settlement of preferred stock warrant
|
—
|
|
|
(1,356
|
)
|
|
—
|
|
|
(100
|
)%
|
|
N/A
|
|
|||
Other expense, net
|
(327
|
)
|
|
(234
|
)
|
|
(404
|
)
|
|
40
|
%
|
|
(42
|
)%
|
|||
Total other expense
|
$
|
(1,159
|
)
|
|
$
|
(10,867
|
)
|
|
$
|
(14,223
|
)
|
|
(89
|
)%
|
|
(24
|
)%
|
|
Years Ended December 31,
|
|
2015 vs. 2014
|
|
2014 vs. 2013
|
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
%
|
|
%
|
||||||||
|
(In thousands, except percentages)
|
||||||||||||||||
Interest expense
|
|
|
|
|
|
|
|
|
|
||||||||
Cash related interest expense
(1)
|
$
|
(802
|
)
|
|
$
|
(1,182
|
)
|
|
$
|
(1,590
|
)
|
|
(32
|
)%
|
|
(26
|
)%
|
|
|
|
|
|
|
|
|
|
|
||||||||
Non-cash interest expense
|
|
|
|
|
|
|
|
|
|
||||||||
Non-cash interest expense — debt issuance costs
|
(39
|
)
|
|
(203
|
)
|
|
(490
|
)
|
|
(81
|
)%
|
|
(59
|
)%
|
|||
Non-cash interest expense — warrant and derivative related debt discounts
|
(5
|
)
|
|
(650
|
)
|
|
(4,128
|
)
|
|
(99
|
)%
|
|
(84
|
)%
|
|||
Non-cash interest expense — convertible notes
|
—
|
|
|
(1,250
|
)
|
|
(9,409
|
)
|
|
(100
|
)%
|
|
(87
|
)%
|
|||
Loss on extinguishment of 2013 Notes
|
—
|
|
|
(8,331
|
)
|
|
—
|
|
|
(100
|
)%
|
|
N/A
|
|
|||
Non-cash interest expense - financing obligation
|
(344
|
)
|
|
(28
|
)
|
|
—
|
|
|
1,129
|
%
|
|
N/A
|
|
|||
Capitalized interest expense
(2)
|
—
|
|
|
972
|
|
|
453
|
|
|
(100
|
)%
|
|
115
|
%
|
|||
Total non-cash interest expense
|
$
|
(388
|
)
|
|
$
|
(9,490
|
)
|
|
$
|
(13,574
|
)
|
|
(96
|
)%
|
|
(30
|
)%
|
|
|
|
|
|
|
|
|
|
|
||||||||
Total interest expense
|
$
|
(1,190
|
)
|
|
$
|
(10,672
|
)
|
|
$
|
(15,164
|
)
|
|
(89
|
)%
|
|
(30
|
)%
|
|
(1)
|
Cash related interest expense included interest payments to Hercules and the Essex Capital Facility.
|
(2)
|
Interest expense capitalized pursuant to
Accounting Standards Codification Topic 835, Interest
.
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Net cash used in operating activities
|
$
|
(55,669
|
)
|
|
$
|
(55,073
|
)
|
|
$
|
(47,758
|
)
|
Net cash used in investing activities
|
(56,340
|
)
|
|
(6,900
|
)
|
|
(6,402
|
)
|
|||
Net cash provided by financing activities
|
142,592
|
|
|
229,091
|
|
|
53,991
|
|
•
|
the results of our clinical trials for RT001 topical and RT002 injectable;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for RT001 topical, RT002 injectable or any future product candidates;
|
•
|
the number and characteristics of any additional product candidates we develop or acquire;
|
•
|
the scope, progress, results and costs of researching and developing RT001 topical, RT002 injectable or any future product candidates, and conducting preclinical and clinical trials;
|
•
|
the cost of commercialization activities if RT001 topical, RT002 injectable or any future product candidates are approved for sale, including marketing, sales and distribution costs;
|
•
|
the cost of manufacturing RT001 topical, RT002 injectable or any future product candidates and any products we successfully commercialize, and maintaining our related facilities;
|
•
|
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the terms of and timing such arrangements;
|
•
|
the degree and rate of market acceptance of any future approved products;
|
•
|
the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments;
|
•
|
any product liability or other lawsuits related to our products;
|
•
|
the expenses needed to attract and retain skilled personnel;
|
•
|
any litigation, including litigation costs and the outcome of such litigation;
|
•
|
the costs associated with being a public company;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and
|
•
|
the timing, receipt and amount of sales of, or royalties on, future approved products, if any.
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Expected term (in years)
|
6.0
|
|
|
6.0
|
|
|
6.0
|
|
Expected volatility
|
62.2
|
%
|
|
57.4
|
%
|
|
59.1
|
%
|
Risk-free interest rate
|
1.6
|
%
|
|
1.9
|
%
|
|
1.3
|
%
|
Dividend rate
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
•
|
Expected term
— The expected term represents the period that our options are expected to be outstanding and is calculated using the simplified method. The Company qualifies for the simplified method as its stock options have the following characteristics: (i) granted at-the-money; (ii) exercisability is conditioned upon service through the vesting date; (iii) termination of service prior to vesting results in forfeiture; (iv) limited exercise period following termination of service; and (v) options are non-transferable and non-hedgeable, or “plain vanilla” options, and the Company has limited history of exercise data.
|
•
|
Expected volatility
— Because our common stock has only been publicly traded for a short time, the expected volatility was derived from the average historic volatilities of several unrelated public companies within our industry that we considered to be comparable to our business over a period equivalent to the expected term of the option.
|
•
|
Risk-free interest rate
— The risk-free interest rate is based on the U.S. Treasury constant maturity rates approximately equal to the option’s expected term.
|
•
|
Dividend rate
— The expected dividend was assumed to be zero as we have never paid dividends and have no current plans to do so.
|
|
February 5, 2014
|
|
|
Upon conversion
|
|
Remaining contractual term (in years)
|
5.9
|
|
Expected volatility
|
55
|
%
|
Risk-free interest rate
|
1.8
|
%
|
Expected dividend rate
|
0
|
%
|
|
Payments Due by Period
|
||||||||||||||||||
Contractual Obligations:
|
Total
|
|
Year 1
|
|
Years 2 to 3
|
|
Years 4 to 5
|
|
More than
5 Years
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Operating lease obligations
(1)
|
$
|
48,548
|
|
|
$
|
5,222
|
|
|
$
|
10,972
|
|
|
$
|
11,710
|
|
|
$
|
20,644
|
|
Other long-term liabilities reflected on our balance sheet under GAAP
(2)
|
9,102
|
|
|
4,217
|
|
|
4,885
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
57,650
|
|
|
$
|
9,439
|
|
|
$
|
15,857
|
|
|
$
|
11,710
|
|
|
$
|
20,644
|
|
|
(1)
|
Operating lease agreements represent our obligations to make payments under non-cancelable lease agreements for our facilities.
|
(2)
|
Other long-term liabilities reflected on our balance sheet under GAAP represents our financing obligation to make lease payments under the Loan and Lease Agreement with Essex Capital.
|
ITEM 7A.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
ITEM 8.
|
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
|
ITEM 9.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
ITEM 9A.
|
CONTROLS AND PROCEDURES
|
ITEM 9B.
|
OTHER INFORMATION
|
ITEM 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
•
|
appointing and retaining an independent registered public accounting firm to serve as independent auditor to audit our Consolidated Financial Statements, overseeing the independent auditor’s work and determining the independent auditor’s compensation;
|
•
|
approving in advance all audit services and non-audit services to be provided to us by our independent auditor;
|
•
|
establishing procedures for the receipt, retention and treatment of complaints received by us regarding accounting, internal accounting controls, auditing or compliance matters, as well as for the confidential, anonymous submission by our employees of concerns regarding questionable accounting or auditing matters;
|
•
|
reviewing and discussing with management and our independent auditor the results of the annual audit and the independent auditor’s review of our quarterly Consolidated Financial Statements; and
|
•
|
conferring with management and our independent auditor about the scope, adequacy and effectiveness of our internal accounting controls, the objectivity of our financial reporting and our accounting policies and practices.
|
ITEM 11.
|
EXECUTIVE COMPENSATION
|
•
|
L. Daniel Browne, President and Chief Executive Officer;
|
•
|
Lauren P. Silvernail, Chief Financial Officer and Chief Business Officer; and
|
•
|
Abhay Joshi, Ph.D., Chief Operating Officer.
|
Name and Principal Position
|
Year
|
Salary($)
|
|
Bonus($)
|
|
Stock Awards
|
Option
Awards($)
(2)
|
Nonequity Incentive Plan Compensation
(1)
|
All Other
Compensation($)
|
|
Total($)
|
L. Daniel Browne
|
2015
|
$482,000
|
|
$—
|
|
$706,005
|
$2,309,582
|
$278,355
|
$—
|
|
$3,775,942
|
President and Chief
Executive Officer
|
2014
|
$452,352
|
|
$—
|
|
$3,093,120
|
$5,207,855
|
$158,323
|
$44,003
|
(6)
|
$8,955,653
|
Lauren P. Silvernail
|
2015
|
$362,505
|
|
$—
|
|
$118,317
|
$387,054
|
$150,780
|
$67,392
|
(5)
|
$1,086,048
|
Chief Financial Officer and Chief Business Officer
|
2014
|
$323,440
|
|
$—
|
|
$451,080
|
$757,058
|
$124,524
|
$67,461
|
(7)
|
$1,723,563
|
Abhay Joshi, Ph.D.
|
2015
|
$21,718
|
(3)
|
$—
|
(4)
|
$1,248,500
|
$4,340,387
|
$—
|
$—
|
|
$5,610,605
|
Chief Operating Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Amounts shown in this column represent cash bonus awards granted to our NEOs under our annual incentive plan. Such bonuses are tied to achievement against clinical and financial goals that are set in the first quarter of the applicable fiscal year, with payouts determined after the close of the year and primarily based on our level of achievement against those goals.
|
(2)
|
The dollar amounts in this column represent the aggregate grant date fair value of all option awards granted during the indicated year. These amounts have been calculated in accordance with FASB ASC Topic 718, or ASC 718, using the Black-Scholes option-pricing model and excluding the effect of estimated forfeitures. For a discussion of valuation assumptions, see Note 16 to our financial statements and the discussion under “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Estimates — Stock-Based Compensation” included elsewhere in this Form 10-K. These amounts do not necessarily correspond to the actual value that may be recognized from the option awards by the NEOs.
|
(3)
|
Dr. Joshi's annual base salary for 2015 was $440,000. The amount shown reflects the salary earned from his date of hire in December 2015 through December 31, 2015.
|
(4)
|
A $200,000 signing bonus will be paid in installments in 2016.
|
(5)
|
Represents taxable fringe benefits for housing and travel.
|
(6)
|
Includes payout of $43,494 for excess vacation and $509 in other taxable benefits.
|
(7)
|
Includes taxable fringe benefits of $66,887 for housing and travel and $574 in other taxable benefits.
|
|
Option Awards
|
Stock Awards
|
||||||||||||
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Option
Exercise
Price ($)
|
Option
Expiration
Date
|
Number of Shares that Have Not Vested
|
Market Value of Shares That Have Not Vested
|
||||||||
L. Daniel Browne
|
20,000
|
|
—
|
|
$
|
2.55
|
|
4/29/2018
|
|
—
|
|
—
|
|
|
|
24,621
|
|
—
|
|
$
|
2.55
|
|
7/20/2020
|
|
—
|
|
—
|
|
|
|
192,942
(1)
|
|
105,808
|
|
$
|
8.70
|
|
5/26/2023
|
|
—
|
|
—
|
|
|
|
49,791
(2)
|
|
49,792
|
|
$
|
9.15
|
|
12/16/2023
|
|
—
|
|
—
|
|
|
|
117,087
(3)
|
|
178,713
|
|
$
|
32.22
|
|
5/18/2024
|
|
—
|
|
—
|
|
|
|
56,489
(4)
|
|
190,011
|
|
$
|
16.23
|
|
1/27/2025
|
|
—
|
|
—
|
|
|
|
—
|
|
—
|
|
$
|
—
|
|
—
|
|
64,000
(5)
|
|
$
|
2,186,240
|
|
|
—
|
|
—
|
|
$
|
—
|
|
0
|
|
43,500
(6)
|
|
$
|
1,485,960
|
|
Lauren P. Silvernail
|
66,256
(7)
|
|
30,117
|
|
$
|
8.70
|
|
5/23/2023
|
|
—
|
|
—
|
|
|
|
17,020
(3)
|
|
25,980
|
|
$
|
32.22
|
|
5/18/2024
|
|
—
|
|
—
|
|
|
|
9,466
(4)
|
|
31,844
|
|
$
|
16.23
|
|
1/27/2025
|
|
—
|
|
—
|
|
|
|
—
|
|
—
|
|
$
|
—
|
|
—
|
|
9,334
(5)
|
|
$
|
318,849
|
|
|
—
|
|
—
|
|
$
|
—
|
|
—
|
|
7,290
(6)
|
|
$
|
249,026
|
|
Abhay Joshi, Ph.D.
|
666
|
|
—
|
|
$
|
6.60
|
|
9/18/2016
|
|
—
|
|
—
|
|
|
|
666
|
|
—
|
|
$
|
4.20
|
|
4/28/2019
|
|
—
|
|
—
|
|
|
|
666
|
|
—
|
|
$
|
2.55
|
|
4/29/2018
|
|
—
|
|
—
|
|
|
|
—
|
|
206,250
(8)
|
|
$
|
36.32
|
|
12/13/2025
|
|
—
|
|
—
|
|
|
|
—
|
|
—
|
|
$
|
—
|
|
—
|
|
34,375
(9)
|
|
$
|
1,174,250
|
|
|
(1)
|
This option was granted on May 27, 2013. The shares subject to the stock option vest over a four year period, with one-forty-eighth of the shares vesting each month, subject to providing continued service to us through each vesting date.
|
(2)
|
This option was granted on December 17, 2013. The shares subject to the stock option vest over a four year period, with one-forty-eighth of the shares vesting each month, subject to providing continued service to us through each vesting date.
|
(3)
|
This option was granted on May 19, 2014. The shares subject to the stock option vest over a four year period, with one-forty-eighth of the shares vesting each month, subject to providing continued service to us through each vesting date.
|
(4)
|
This option was granted on January 28, 2015. The shares subject to the stock option vest over a four year period, with one-forty-eighth of the shares vesting each month, subject to providing continued service to us through each vesting date.
|
(5)
|
This restricted stock award was granted on May 19, 2014. The shares subject to the stock award vest over a three year period, with one-third of the shares vesting each year, subject to providing continued service to us through each vesting date.
|
(6)
|
This restricted stock award was granted on January 28, 2015. The shares subject to the stock award vest over a three year period, with one-third of the shares vesting each year, subject to providing continued service to us through each vesting date.
|
(7)
|
This option was granted on May 24, 2013. The shares subject to the stock option vest over a four year period, with 25% vesting on March 18, 2014 and the balance vesting each month over the remaining three-year period, subject to providing continued service to us through each vesting date.
|
(8)
|
This option was granted on December 14, 2015. The shares subject to the stock option vest over a four year period, with 25% vesting on December 14, 2016 and the balance vesting each month over the remaining three-year period, subject to providing continued service to us through each vesting date.
|
(9)
|
This restricted stock award was granted on December 14, 2015. The shares subject to the stock award vest over a four year period, with one-fourth of the shares vesting each year, subject to providing continued service to us through each vesting date.
|
Name
|
Fees Earned ($)
|
Stock
Options
($)*
|
|
Total ($)
|
Robert Byrnes
|
63.75
|
86.77
|
(1)
|
150.52
|
Ronald W. Eastman
|
44.37
|
86.77
|
(2)
|
131.13
|
Phyllis Gardner, M.D.
|
46.61
|
86.77
|
(3)
|
133.37
|
James Glasheen, Ph.D.
|
47.00
|
86.77
|
(4)
|
133.77
|
Mark A. Prygocki
|
59.50
|
86.77
|
(5)
|
146.27
|
Angus C. Russell
|
72.00
|
86.77
|
(6)
|
158.77
|
Jonathan Tunnicliffe
|
41.61
|
86.77
|
(7)
|
128.37
|
Philip J. Vickers, Ph.D.
|
38.62
|
248.70
|
(8)
|
287.32
|
Ronald Wooten
|
39.50
|
86.77
|
(9)
|
126.27
|
|
*
|
The dollar amounts in this column represent the grant date fair value of the stock option award. These amounts have been calculated in accordance with ASC 718 using the Black-Scholes option-pricing model and excluding the effect of estimated forfeitures. For a discussion of valuation assumptions, see Note 16 to our financial statements and the discussion under “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Estimates — Stock-Based Compensation” included elsewhere in this Form 10-K. These amounts do not necessarily correspond to the actual value that may be recognized from the option awards by the applicable directors.
|
(1)
|
As of December 31, 2015, Mr. Byrnes had options to purchase 50,332 shares of our common stock.
|
(2)
|
As of December 31, 2015, Mr. Eastman had options to purchase 16,000 shares of our common stock.
|
(3)
|
As of December 31, 2015, Dr. Gardner had options to purchase 21,333 shares of our common stock.
|
(4)
|
As of December 31, 2015, Dr. Glasheen had options to purchase 16,000 shares of our common stock.
|
(5)
|
As of December 31, 2015, Mr. Prygocki had options to purchase 26,000 shares of our common stock.
|
(6)
|
As of December 31, 2015, Mr. Russell had options to purchase 26,000 shares of our common stock.
|
(7)
|
As of December 31, 2015, Mr. Tunnicliffe had options to purchase 16,000 shares of our common stock.
|
(8)
|
Dr. Vickers joined our board of directors in February 2015. As of December 31, 2015, Dr. Vickers had options to purchase 26,000 shares of our common stock.
|
(9)
|
As of December 31, 2015, Mr. Wooten had options to purchase 16,000 shares of our common stock.
|
|
Member
Annual Service
Retainer
|
|
Chairman Additional
Annual Service
Retainer
|
||||
Board of Directors
|
$
|
39,500
|
|
|
$
|
34,500
|
|
Audit Committee
|
7,500
|
|
|
12,500
|
|
||
Compensation Committee
|
5,000
|
|
|
7,250
|
|
||
Nominating and Corporate Governance Committee
|
4,500
|
|
|
3,500
|
|
||
Science & Technology Committee
|
5,000
|
|
|
7,250
|
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
Plan Category
|
Number of securities to be
issued upon exercise
of outstanding options,
warrants and rights
(a)
|
|
Weighted-average exercise
price of outstanding options,
warrants and rights
(b)
(3)
|
|
Number of securities
remaining available for issuance under
equity compensation plans (excluding
securities reflected in column (a))
(c)
|
||||
Equity compensation plans approved by security holders:
(1)
|
2,103,261
|
|
|
$
|
18.36
|
|
|
670,608
(4)
|
|
Equity compensation plans not approved by security holders:
(2)
|
316,844
|
|
|
$
|
31.46
|
|
|
449,889
|
|
Total
|
2,420,105
|
|
|
$
|
20.08
|
|
|
1,120,497
|
|
(1)
|
Includes securities issuable under the 2002 Equity Incentive Plan, the 2012 Equity Incentive Plan, the 2014 Equity Incentive Plan, or the 2014 plan, and the 2014 Employee Stock Purchase Plan, or the 2014 ESPP.
|
(2)
|
Includes securities issuable under the 2014 Inducement Plan adopted exclusively for grants of awards to individuals that were not previously our employees or directors, as an inducement material to the individual’s entry into employment with us within the meaning of Rule 5635(c)(4) of the NASDAQ Listing Rules.
|
(3)
|
The weighted average exercise price excludes restricted stock awards, which have no exercise price.
|
(4)
|
Includes (i) 273,948 shares of common stock available for issuance under our 2014 plan and (ii) 396,660 shares of common stock available for issuance under our 2014 ESPP. The number of shares of our common stock reserved for issuance under the 2014 plan automatically increases on January 1st of each year, starting on January 1, 2015 and continuing through January 1, 2024, by 4% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, or such lesser number of shares of common stock as determined by our Board of Directors. The maximum number of shares that may be issued pursuant to the exercise of incentive stock options under the 2014 plan is 2,000,000 shares. The number of shares of our common stock reserved under the 2014 ESPP for issuance automatically increases on January 1st each year, starting January 1, 2015 and continuing through January 1, 2024, in an amount equal to the lower of (i) 1% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, and (ii) 300,000 shares of common stock, or such lesser number of shares of common stock as determined by our Board of Directors. If a purchase right granted under our 2014 ESPP terminates without having been exercised, the shares of our common stock not purchased under such purchase right will be available for issuance under our 2014 ESPP.
|
|
Beneficial Ownership
|
|||
Name of Beneficial Owner
|
Number of
Shares
|
Percentage
of Total
|
||
Named Executive Officers and Directors:
|
|
|
||
L. Daniel Browne
(1)
|
719,207
|
|
2.50
|
%
|
Abhay Joshi
(2)
|
36,373
|
|
*
|
|
Lauren P. Silvernail
(3)
|
123,026
|
|
*
|
|
Robert Byrnes
(4)
|
44,998
|
|
*
|
|
Ronald W. Eastman
(5)
|
4,142,962
|
|
14.64
|
%
|
Phyllis Gardner, M.D.
(6)
|
13,333
|
|
*
|
|
James Glasheen, Ph.D.
(7)
|
734,014
|
|
2.59
|
%
|
Mark A. Prygocki
(8)
|
18,000
|
|
-
|
|
Angus C. Russell
(9)
|
18,000
|
|
*
|
|
Jonathan Tunnicliffe
(10)
|
3,112,650
|
|
11.00
|
%
|
Philip J. Vickers, Ph.D.
(11)
|
18,000
|
|
*
|
|
Ronald Wooten
(10)
|
3,112,650
|
|
11.00
|
%
|
Directors and officers as a group (total of 13 persons)
(12)
|
9,066,324
|
|
31.15
|
%
|
Greater than 5% Stockholders:
|
|
|
||
Entities affiliated with Essex VIII
(5)
|
4,142,962
|
|
14.64
|
%
|
Entities affiliated with NovaQuest
(10)
|
3,112,650
|
|
11.00
|
%
|
Entities affiliated with Franklin Resources
(13)
|
3,178,895
|
|
11.24
|
%
|
Entities affiliated with JPMorgan Chase & Co.
(14)
|
2,937,142
|
|
10.38
|
%
|
Entities affiliated with The Bank of New York Mellon Corporation
(15)
|
2,009,567
|
|
7.10
|
%
|
Entities affiliated with BlackRock, Inc.
(16)
|
1,564,691
|
|
5.53
|
%
|
|
(1)
|
Consists of 218,677 shares of common stock and 500,121 shares of common stock underlying options that are vested and exercisable within 60 days of January 15, 2016 and 409 shares of common stock held by the Dan and Brenda Browne Living Trust. Mr. Browne is a Trustee of the Dan and Brenda Browne Living Trust.
|
(2)
|
Consists of 34,375 shares of common stock and 1,998 shares of common stock underlying options that are vested and exercisable within 60 days of January 15, 2016.
|
(3)
|
Consists of 22,758 shares of common stock and 100,268 shares of common stock underlying options that are vested and exercisable within 60 days of January 15, 2016.
|
(4)
|
Consists of 2,666 shares of common stock and 42,332 shares of common stock underlying options that are vested and exercisable within 60 days of January 15, 2015.
|
(5)
|
Consists of 8,000 shares of common stock underlying options held by Mr. Eastman that are vested and exercisable within 60 days of January 15, 2016, 3,747,332 shares of common stock held by Essex Woodlands Health Ventures Fund VIII, L.P. (“Essex Fund VIII”), 270,172 shares of common stock held by Essex Woodlands Health Ventures Fund VIII-A, L.P. (“Essex Fund VIII-A”) and 117,458 shares of common stock held by Essex Woodlands Health Ventures Fund VIII-B, L.P. (“Essex Fund VIII-B”). Essex Woodlands Health Ventures VIII, LLC, the general partner of Essex Fund VIII, Essex Fund VIII-A and Essex Fund VIII-B, may be deemed to have sole power to vote and sole power to dispose of shares directly owned by Essex Fund VIII, Essex Fund VIII-A and Essex Fund VIII-B. Ronald W. Eastman, one of our directors, is a managing member of Essex Woodlands Health Ventures VIII, LLC and may be
|
(6)
|
Consists of 13,333 shares of common stock underlying options that are vested and exercisable within 60 days of January 15, 2016.
|
(7)
|
Consists of 8,000 shares of common stock underlying options held by Mr. Glasheen that are vested and exercisable within 60 days of January 15, 2016, 16,852 shares of common stock held by Technology Partners Affiliates VII, L.P. (“TPA”) and 709,162 shares of common stock held by Technology Partners Fund VII, L.P. (“TPF”). TP Management VII, L.L.C., the general partner of TPA and TPF, may be deemed to have sole power to vote and sole power to dispose of shares directly owned by TPA and TPF. James Glasheen, one of our directors, is a managing member of TP Management VII, L.L.C. and may be deemed to have shared voting power and shared power to dispose of the shares held by TPA and TPF. The address for Technology Partners is 550 University Avenue, Palo Alto, California 94301.
|
(8)
|
Consists of 18,000 shares of common stock underlying options that are vested and exercisable within 60 days of January 15, 2016.
|
(9)
|
Consists of 18,000 shares of common stock underlying options that are vested and exercisable within 60 days of January 15, 2016.
|
(10)
|
Consists of 8,000 shares of common stock underlying options held by Mr. Tunnicliffe that are vested and exercisable within 60 days of January 15, 2016, 8,000 shares of common stock underlying options held by Mr. Wooten that are vested and exercisable within 60 days of January 15, 2016, and 3,096,650 shares of common stock held by NovaQuest Pharma Opportunities Fund III, L.P. (“NovaQuest”). Under NovaQuest's partnership agreement, Messrs. Tunnicliffe and Wooten are deemed to hold the options for the benefit of NovaQuest, and must exercise the options solely upon the direction of NovaQuest, which is entitled to the shares issued upon exercise. NQ HCIF General Partner, L.P., as the general partner of NovaQuest (the “NovaQuest GP”), has the power to vote and dispose of shares directly owned by NovaQuest, and NQ HCIF GP Ltd., as the general partner of the NovaQuest GP (the “NovaQuest GP Ltd.”), has the power to direct the NovaQuest GP as to such voting and disposition. Decisions with respect to the voting and disposition of the shares held by NovaQuest are made by an investment committee of the NovaQuest GP Ltd., on which Jonathan Tunnicliffe and Ronald Wooten, two of our directors, each serve. Ronald Wooten also serves on the board of directors of the NovaQuest GP Ltd. Pursuant to these positions, Jonathan Tunnicliffe and Ronald Wooten may be deemed to have shared voting power and shared power to dispose of the shares held by NovaQuest. The NovaQuest GP, the NovaQuest GP Ltd., each member of the investment committee, Mr. Tunnicliffe and Mr. Wooten disclaims beneficial ownership of the shares held by NovaQuest except to the extent of his or its pecuniary interest therein. The address for each of the foregoing persons and entities is 4208 Six Forks Road, Suite 920, Raleigh, North Carolina 27609.
|
(11)
|
Consists of 18,000 shares of common stock underlying options that are vested and exercisable within 60 days of January 15, 2016.
|
(12)
|
Includes shares beneficially owned by all current executive officers and directors of the company. Consists of 8,254,538 shares of common stock and 811,786 shares of common stock underlying options that are vested and exercisable within 60 days of January 15, 2016.
|
(13)
|
The indicated ownership is based on a Schedule 13G filed with the SEC by the reporting persons on February 10, 2016, reporting beneficial ownership as of December 31, 2015. According to the Schedule 13G, the reporting persons beneficially own a total of 3,178,895 shares of Common Stock held by Franklin Resources, Inc. (“FRI”), Franklin Advisers, Inc., Charles B. Johnson and Rupert H. Johnson, Jr. The Schedule 13G filed by the reporting persons provides information only as of December 31, 2015, and, consequently, the beneficial ownership of the above-mentioned reporting persons may have changed between December 31, 2015 and January 15, 2016. The address for each of the foregoing persons and entities is One Franklin Parkway, San Mateo, CA 94403.
|
(14)
|
The indicated ownership is based on a Schedule 13G/A filed with the SEC by the reporting persons on January 21, 2016, reporting beneficial ownership as of December 31, 2015. According to the Schedule 13G/A, the reporting persons beneficially own a total of 2,937,142 shares of Common Stock held by JPMorgan Chase & Co. and its wholly owned subsidiaries JPMorgan BankChase, National Association, J.P. Morgan Investment Management Inc., JPMorgan Asset Management (UK) Limited and J.P. Morgan Securities LLC. The Schedule 13G/A filed by the reporting persons provides information only as of December 31, 2015, and, consequently, the beneficial ownership of the above-mentioned reporting persons may have changed between December 31, 2015 and January 15, 2016. The address for each of the foregoing persons and entities is 270 Park Ave. New York, NY 10017.
|
(15)
|
The indicated ownership is based on a Schedule 13G filed with the SEC by the reporting persons on January 26, 2016, reporting beneficial ownership as of December 31, 2015. According to the Schedule 13G, the reporting persons beneficially own a total of 2,009,567 shares of Common Stock held by The Bank of New York Mellon Corporation and its following affiliates: The Bank of New York Mellon, The Boston Company Asset Management LLC, The Dreyfus Corporation (parent holding company of MBSC Securities Corporation), Mellon Capital Management Corporation, MAM (MA) Holding Trust (parent holding company of Standish Mellon Asset Management Company
|
(16)
|
The indicated ownership is based on a Schedule 13G filed with the SEC by the reporting persons on January 28, 2016, reporting beneficial ownership as of December 31, 2015. According to the Schedule 13G, the reporting persons beneficially own a total of 1,564,691 shares of Common Stock held by BlackRock Inc. and its subsidiaries BlackRock Advisors, LLC, BlackRock Asset Management Canada Limited, BlackRock Asset Management Ireland Limited, BlackRock Asset Management Schweiz AG, BlackRock Fund Advisors, BlackRock Institutional Trust Company, N.A. and BlackRock Investment Management, LLC. The Schedule 13G filed by the reporting persons provides information only as of December 31, 2015, and, consequently, the beneficial ownership of the above-mentioned reporting persons may have changed between December 31, 2015 and January 15, 2016. The address for each of the foregoing persons and entities is 55 East 52nd Street, New York, NY 10055.
|
ITEM 13.
|
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
|
ITEM 14.
|
PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
|
2015
|
|
2014
|
||||
Audit Fees
(1)
|
$
|
906,482
|
|
|
$
|
1,266,360
|
|
|
(1)
|
Audit Fees consist of professional services rendered in connection with the audit of our Consolidated Financial Statements and review of our quarterly Consolidated Financial Statements. Fees for fiscal 2014 also include fees associated with our IPO completed in February 2014, which included review of our quarterly Consolidated Financial information included in our registration statement on Form S-1 filed with the SEC, as well as delivery of comfort letters, consents and review of documents filed with the SEC. Fees for fiscal 2015 and 2014 also include fees associated with our follow on offerings completed in November 2015 and June 2014, respectively, which included delivery of comfort letters, consents and review of documents filed with the SEC.
|
•
|
Audit services
. Audit services include work performed for the audit of our financial statements and the review of financial statements included in our quarterly reports, as well as work that is normally provided by the independent registered public accounting firm in connection with statutory and regulatory filings.
|
•
|
Audit-related services
. Audit-related services are for assurance and related services that are reasonably related to the performance of the audit or review of our financial statements and are not covered above under “audit services.”
|
•
|
Tax services
. Tax services include all services performed by the independent registered public accounting firm’s tax personnel for tax compliance, tax advice and tax planning.
|
•
|
Other services
. Other services are those services not described in the other categories.
|
ITEM 15.
|
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
|
|
Page
|
F-2
|
|
Consolidated Financial Statements:
|
|
F-3
|
|
F-4
|
|
F-5
|
|
F-12
|
|
F-14
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Revenue
|
$
|
300
|
|
|
$
|
383
|
|
|
$
|
617
|
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
47,529
|
|
|
33,390
|
|
|
27,831
|
|
|||
General and administrative
|
25,088
|
|
|
19,043
|
|
|
11,011
|
|
|||
Total operating expenses
|
72,617
|
|
|
52,433
|
|
|
38,842
|
|
|||
Loss from operations
|
(72,317
|
)
|
|
(52,050
|
)
|
|
(38,225
|
)
|
|||
Interest income
|
231
|
|
|
44
|
|
|
2
|
|
|||
Interest expense
|
(1,190
|
)
|
|
(10,672
|
)
|
|
(15,164
|
)
|
|||
Change in fair value of derivative liabilities associated with the convertible notes
|
—
|
|
|
4,032
|
|
|
2,660
|
|
|||
Changes in fair value of derivative liabilities associated with Medicis settlement
|
127
|
|
|
(320
|
)
|
|
47
|
|
|||
Change in fair value of common stock warrant liability
|
—
|
|
|
(2,151
|
)
|
|
(621
|
)
|
|||
Change in fair value of convertible preferred stock warrant liability
|
—
|
|
|
(210
|
)
|
|
(743
|
)
|
|||
Loss on settlement of preferred stock warrant
|
—
|
|
|
(1,356
|
)
|
|
—
|
|
|||
Other expense, net
|
(327
|
)
|
|
(234
|
)
|
|
(404
|
)
|
|||
Net loss
|
(73,476
|
)
|
|
(62,917
|
)
|
|
(52,448
|
)
|
|||
Unrealized loss on available for sale securities
|
(40
|
)
|
|
—
|
|
|
—
|
|
|||
Comprehensive loss
|
$
|
(73,516
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
(52,448
|
)
|
Net income (loss) attributable to common stockholders (Note 15):
|
|
|
|
|
|
||||||
Basic
|
$
|
(73,476
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
258
|
|
Diluted
|
$
|
(73,476
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
1,083
|
|
Net income (loss) per share attributable to common stockholders:
|
|
|
|
|
|
||||||
Basic
|
$
|
(3.02
|
)
|
|
$
|
(3.24
|
)
|
|
$
|
1.17
|
|
Diluted
|
$
|
(3.02
|
)
|
|
$
|
(3.24
|
)
|
|
$
|
1.05
|
|
Weighted-average number of shares used in computing net income (loss) per share attributable to common stockholders:
|
|
|
|
|
|
||||||
Basic
|
24,340,466
|
|
|
19,391,523
|
|
|
220,220
|
|
|||
Diluted
|
24,340,466
|
|
|
19,391,523
|
|
|
1,029,150
|
|
|
Convertible Preferred
Stock |
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Other Accumulated
Comprehensive Income (Loss) |
|
Accumulated Deficit
|
|
Total
Stockholders’ Equity (Deficit) |
||||||||||||||||||
|
Shares
|
|
Amount
|
Shares
|
|
Amount
|
|
|||||||||||||||||||||||
Balance — December 31, 2012
|
1,517,381
|
|
|
$
|
95,433
|
|
|
|
204,024
|
|
|
$
|
—
|
|
|
$
|
1,599
|
|
|
$
|
—
|
|
|
$
|
(218,326
|
)
|
|
$
|
(216,727
|
)
|
Stock-based compensation expense related to stock options
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
548
|
|
|
—
|
|
|
—
|
|
|
548
|
|
||||||
Conversion of Series A and B convertible preferred stock into Series E-1 convertible preferred stock
|
—
|
|
|
(11,256
|
)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11,256
|
|
|
11,256
|
|
||||||
Conversion of Series C convertible preferred stock into Series E-2 convertible preferred stock
|
—
|
|
|
(39,000
|
)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
39,000
|
|
|
39,000
|
|
||||||
Conversion of Series D convertible preferred stock into Series E-3 convertible preferred stock
|
607,476
|
|
|
(24,638
|
)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
24,638
|
|
|
24,638
|
|
||||||
Conversion of 2011 Notes into Series E-4 convertible preferred stock
|
4,748,484
|
|
|
66,954
|
|
|
|
—
|
|
|
—
|
|
|
32,008
|
|
|
—
|
|
|
—
|
|
|
32,008
|
|
||||||
Issuance of Series E-5 convertible preferred stock for cash at $22.50 per share in February through May 2013, net of issuance costs of $132
|
1,810,441
|
|
|
36,375
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of Series E-5 convertible preferred stock as a deemed dividend
|
7,911
|
|
|
177
|
|
|
|
—
|
|
|
—
|
|
|
(177
|
)
|
|
—
|
|
|
—
|
|
|
(177
|
)
|
||||||
Issuance of common stock warrants in connection with Series E-5 convertible preferred stock financing
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
4,272
|
|
|
—
|
|
|
—
|
|
|
4,272
|
|
||||||
Expiration of note payable from stockholder, Series E-1
|
(1,694
|
)
|
|
(63
|
)
|
|
|
—
|
|
|
—
|
|
|
63
|
|
|
—
|
|
|
—
|
|
|
63
|
|
||||||
Exercise of stock options at $2.55 per share
|
—
|
|
|
—
|
|
|
|
4,284
|
|
|
—
|
|
|
11
|
|
|
—
|
|
|
—
|
|
|
11
|
|
||||||
Exercise of common stock warrants at $0.15 per share
|
—
|
|
|
—
|
|
|
|
52,481
|
|
|
—
|
|
|
7
|
|
|
—
|
|
|
—
|
|
|
7
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(52,448
|
)
|
|
(52,448
|
)
|
||||||
Balance — December 31, 2013
|
8,689,999
|
|
|
123,982
|
|
|
|
260,789
|
|
|
—
|
|
|
38,331
|
|
|
—
|
|
|
(195,880
|
)
|
|
(157,549
|
)
|
||||||
Issuance of common stock relating to employee stock purchase plan
|
—
|
|
|
—
|
|
|
|
25,339
|
|
|
—
|
|
|
349
|
|
|
—
|
|
|
—
|
|
|
349
|
|
||||||
Stock-based compensation expense related to stock options, restricted stock awards, and employee stock purchase plan
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
6,513
|
|
|
—
|
|
|
—
|
|
|
6,513
|
|
||||||
Conversion of preferred stock to common stock in connection with initial public offering
|
(8,689,999
|
)
|
|
(123,982
|
)
|
|
|
8,689,999
|
|
|
9
|
|
|
123,972
|
|
|
—
|
|
|
—
|
|
|
123,981
|
|
||||||
Conversion of preferred stock warrants to common stock warrants in connection with initial public offering
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
1,441
|
|
|
—
|
|
|
—
|
|
|
1,441
|
|
||||||
Issuance of common stock in connection with initial public offering, net of underwriting discounts, commissions and issuance costs of $11,800
|
—
|
|
|
—
|
|
|
|
6,900,000
|
|
|
7
|
|
|
98,637
|
|
|
—
|
|
|
—
|
|
|
98,644
|
|
||||||
Issuance of common stock upon conversion of 2013 convertible notes in connection with initial public offering
|
—
|
|
|
—
|
|
|
|
1,637,846
|
|
|
2
|
|
|
26,204
|
|
|
—
|
|
|
—
|
|
|
26,206
|
|
||||||
Issuance of common stock upon net exercise of common stock warrants and related extinguishment of warrant liability in connection with initial public offering
|
—
|
|
|
—
|
|
|
|
1,158,443
|
|
|
1
|
|
|
6,489
|
|
|
—
|
|
|
—
|
|
|
6,490
|
|
||||||
Issuance of common stock in connection with the 2014 follow on offering, net of underwriting discounts, commissions and issuance costs of $9,000
|
—
|
|
|
—
|
|
|
|
4,600,000
|
|
|
5
|
|
|
131,330
|
|
|
—
|
|
|
—
|
|
|
131,335
|
|
||||||
Issuance of common stock upon net exercise of warrant
|
—
|
|
|
—
|
|
|
|
10,613
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of common stock upon exercise of stock options
|
—
|
|
|
—
|
|
|
|
239,000
|
|
|
—
|
|
|
1,422
|
|
|
—
|
|
|
—
|
|
|
1,422
|
|
||||||
Issuance of restricted stock awards, net of repurchase
|
—
|
|
|
—
|
|
|
|
251,325
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of common stock warrants
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
379
|
|
|
—
|
|
|
—
|
|
|
379
|
|
||||||
Issuance of common stock at $15.45 per share for services rendered
|
—
|
|
|
—
|
|
|
|
1,111
|
|
|
—
|
|
|
17
|
|
|
—
|
|
|
—
|
|
|
17
|
|
||||||
Termination of repurchase rights related to vesting of common stock issued pursuant to early exercises
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
58
|
|
|
—
|
|
|
—
|
|
|
58
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(62,917
|
)
|
|
(62,917
|
)
|
||||||
Balance — December 31, 2014
|
—
|
|
|
—
|
|
|
|
23,774,465
|
|
|
24
|
|
|
435,142
|
|
|
—
|
|
|
(258,797
|
)
|
|
176,369
|
|
||||||
Issuance of common stock relating to employee stock purchase plan
|
—
|
|
|
—
|
|
|
|
15,745
|
|
|
—
|
|
|
318
|
|
|
—
|
|
|
—
|
|
|
318
|
|
||||||
Stock-based compensation expense related to stock options, restricted stock awards, and employee stock purchase plan
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
12,388
|
|
|
—
|
|
|
—
|
|
|
12,388
|
|
||||||
Issuance of common stock in connection with At-The-Market offering, net of issuance costs
|
—
|
|
|
—
|
|
|
|
352,544
|
|
|
—
|
|
|
10,021
|
|
|
—
|
|
|
—
|
|
|
10,021
|
|
||||||
Issuance of common stock in connection with the 2015 follow-on offering, net of issuance costs
|
—
|
|
|
—
|
|
|
|
3,737,500
|
|
|
4
|
|
|
126,226
|
|
|
—
|
|
|
—
|
|
|
126,230
|
|
||||||
Issuance of common stock upon net exercise of warrants
|
—
|
|
|
—
|
|
|
|
68,993
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of common stock upon exercise of stock options
|
—
|
|
|
—
|
|
|
|
205,735
|
|
|
—
|
|
|
2,435
|
|
|
—
|
|
|
—
|
|
|
2,435
|
|
||||||
Issuance of restricted stock awards, net of repurchase
|
—
|
|
|
—
|
|
|
|
169,562
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Vested restricted stock awards used to pay for taxes
|
—
|
|
|
—
|
|
|
|
(36,080
|
)
|
|
—
|
|
|
(993
|
)
|
|
—
|
|
|
—
|
|
|
(993
|
)
|
||||||
Unrealized loss on available for sale securities
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(40
|
)
|
|
—
|
|
|
(40
|
)
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(73,476
|
)
|
|
(73,476
|
)
|
||||||
Balance — December 31, 2015
|
—
|
|
|
$
|
—
|
|
|
|
28,288,464
|
|
|
$
|
28
|
|
|
$
|
585,537
|
|
|
$
|
(40
|
)
|
|
$
|
(332,273
|
)
|
|
$
|
253,252
|
|
|
Year Ended
December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
||||||
Net loss
|
$
|
(73,476
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
(52,448
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation
|
1,995
|
|
|
2,051
|
|
|
1,881
|
|
|||
Amortization of premium on investments
|
601
|
|
|
—
|
|
|
—
|
|
|||
Amortization of discount on debt and capital leases
|
5
|
|
|
1,250
|
|
|
4,128
|
|
|||
Amortization of debt issuance cost
|
39
|
|
|
203
|
|
|
217
|
|
|||
Change in fair value of derivative liabilities associated with convertible notes
|
—
|
|
|
(4,032
|
)
|
|
(2,660
|
)
|
|||
Change in fair value of derivative liabilities associated with the Medicis settlement
|
(127
|
)
|
|
320
|
|
|
(47
|
)
|
|||
Change in fair value of common stock warrant liability
|
—
|
|
|
2,151
|
|
|
621
|
|
|||
Change in fair value of convertible preferred stock warrant liability
|
—
|
|
|
210
|
|
|
(425
|
)
|
|||
Extinguishment of warrant liability upon exercise of put option by warrant holder
|
—
|
|
|
1,356
|
|
|
—
|
|
|||
Convertible preferred stock warrant modification remeasurement adjustment
|
—
|
|
|
—
|
|
|
1,168
|
|
|||
Loss on extinguishment of 2013 Notes
|
—
|
|
|
8,331
|
|
|
—
|
|
|||
Stock-based compensation expense
|
12,388
|
|
|
6,530
|
|
|
548
|
|
|||
Interest on convertible notes converted to convertible preferred stock
|
—
|
|
|
—
|
|
|
9,220
|
|
|||
Interest for 2013 Notes and Essex Notes upon issuance, non-cash
|
—
|
|
|
271
|
|
|
273
|
|
|||
Capitalized interest
|
—
|
|
|
(972
|
)
|
|
(453
|
)
|
|||
Fair value of common stock warrants issued
|
—
|
|
|
379
|
|
|
—
|
|
|||
Effective interest on financing obligations
|
344
|
|
|
28
|
|
|
—
|
|
|||
Loss on disposal of fixed assets
|
38
|
|
|
—
|
|
|
—
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Prepaid expenses and other current assets
|
(192
|
)
|
|
(999
|
)
|
|
422
|
|
|||
Other non-current assets
|
29
|
|
|
(1,621
|
)
|
|
(2,770
|
)
|
|||
Accounts payable
|
(692
|
)
|
|
(3,399
|
)
|
|
3,193
|
|
|||
Accruals and other current liabilities
|
3,179
|
|
|
2,311
|
|
|
(3,832
|
)
|
|||
Payments against Medicis liabilities
|
—
|
|
|
(7,073
|
)
|
|
(6,927
|
)
|
|||
Deferred rent
|
200
|
|
|
549
|
|
|
133
|
|
|||
Net cash used in operating activities
|
(55,669
|
)
|
|
(55,073
|
)
|
|
(47,758
|
)
|
|||
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(3,328
|
)
|
|
(6,975
|
)
|
|
(6,477
|
)
|
|||
Proceeds from maturities of investments
|
1,000
|
|
|
—
|
|
|
—
|
|
|||
Purchases of investments
|
(54,087
|
)
|
|
—
|
|
|
—
|
|
|||
Change in restricted cash
|
75
|
|
|
75
|
|
|
75
|
|
|||
Net cash used in investing activities
|
(56,340
|
)
|
|
(6,900
|
)
|
|
(6,402
|
)
|
|||
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
||||||
Proceeds from issuance of common stock, net of deferred 2015 follow-on offering costs
|
126,230
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from issuance of common stock, net of deferred at-the-market offering costs
|
10,021
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from failed sale-leaseback financings
|
9,831
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from the exercise of stock options, employee stock purchase plan, and common stock warrants
|
2,753
|
|
|
1,771
|
|
|
18
|
|
|||
Net settlement of restricted stock awards to settle employee taxes
|
(993
|
)
|
|
—
|
|
|
—
|
|
|||
Principal payments made on capital leases and financing obligations
|
(2,598
|
)
|
|
(228
|
)
|
|
(982
|
)
|
|||
Principal payments made on notes payable
|
(2,652
|
)
|
|
(12,316
|
)
|
|
(7,594
|
)
|
|||
Proceeds from issuance of common stock, net of deferred 2014 follow-on public offering costs
|
—
|
|
|
131,880
|
|
|
—
|
|
|||
Proceeds from issuance of common stock, net of deferred initial public offering costs
|
—
|
|
|
102,672
|
|
|
—
|
|
|||
Proceeds from issuance of convertible notes and notes payable
|
—
|
|
|
6,750
|
|
|
21,903
|
|
|||
Payments to settle warrants
|
—
|
|
|
(1,438
|
)
|
|
—
|
|
|||
Proceeds from issuance of convertible preferred stock, net
|
—
|
|
|
—
|
|
|
40,646
|
|
|||
Net cash provided by financing activities
|
142,592
|
|
|
229,091
|
|
|
53,991
|
|
|||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
30,583
|
|
|
167,118
|
|
|
(169
|
)
|
|||
CASH AND CASH EQUIVALENTS — Beginning of period
|
171,032
|
|
|
3,914
|
|
|
4,083
|
|
|||
CASH AND CASH EQUIVALENTS — End of period
|
201,615
|
|
|
171,032
|
|
|
3,914
|
|
|||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
|
|
|
|
|
|
||||||
Cash paid for interest
|
802
|
|
|
1,182
|
|
|
1,590
|
|
|||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION:
|
|
|
|
|
|
||||||
Conversion of Series E-1, E-2, E-3, E-4 and E-5 preferred stock into common stock
|
—
|
|
|
123,982
|
|
|
—
|
|
|||
Conversion of 2013 Notes into common stock
|
—
|
|
|
26,206
|
|
|
—
|
|
|||
Issuance of common stock upon net exercise of common stock warrants in connection with IPO
|
—
|
|
|
6,490
|
|
|
—
|
|
|||
Fair value in excess of debt host for derivative liabilities associated with convertible notes
|
—
|
|
|
1,050
|
|
|
5,750
|
|
|||
Deferred initial public offering costs
|
—
|
|
|
4,028
|
|
|
2,490
|
|
|||
Deferred follow-on public offering costs
|
—
|
|
|
546
|
|
|
—
|
|
|||
Conversion of preferred stock warrants to common stock warrants
|
—
|
|
|
1,441
|
|
|
—
|
|
|||
Conversion of Essex Notes into financing obligations
|
—
|
|
|
1,095
|
|
|
—
|
|
|||
Termination of stock option repurchase right
|
—
|
|
|
58
|
|
|
—
|
|
|||
Capital contribution on the extinguishment of the prior convertible preferred stock
|
—
|
|
|
—
|
|
|
74,894
|
|
|||
Capital contribution on the extinguishment of the 2011 Notes
|
—
|
|
|
—
|
|
|
32,008
|
|
|||
Deemed dividend on issuance of Series E-5 convertible preferred stock
|
—
|
|
|
—
|
|
|
177
|
|
|||
Issuance of common stock warrants in connection with Series E-5 convertible preferred stock financing
|
—
|
|
|
—
|
|
|
4,272
|
|
|||
Issuance of common stock warrants in connection with the 2013 Notes
|
—
|
|
|
981
|
|
|
2,737
|
|
|||
Property and equipment purchases included in accounts payable and accruals and other current liabilities
|
487
|
|
|
1,348
|
|
|
2,285
|
|
|||
Issuance of convertible preferred stock warrants
|
—
|
|
|
80
|
|
|
139
|
|
|||
Fair value of common stock warrants issued
|
—
|
|
|
379
|
|
|
—
|
|
|
Level 1
|
—
|
Observable inputs, such as quoted prices in active markets for identical assets or liabilities.
|
|
|
|
|
|
Level 2
|
—
|
Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
|
|
|
|
|
Level 3
|
—
|
Valuations based on unobservable inputs to the valuation methodology and including data about assumptions market participants would use in pricing the asset or liability based on the best information available under the circumstances.
|
|
December 31, 2015
|
|
December 31, 2014
|
||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
|
Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
||||||||||||||||
Money market funds
|
$
|
145,747
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
145,747
|
|
|
$
|
166,038
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
166,038
|
|
U.S. government agency obligations
|
52,479
|
|
|
—
|
|
|
(40
|
)
|
|
52,439
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Total cash equivalents and available-for-sale securities
|
$
|
198,226
|
|
|
$
|
—
|
|
|
$
|
(40
|
)
|
|
$
|
198,186
|
|
|
$
|
166,038
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
166,038
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Classified as:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Cash equivalents
|
|
|
|
|
|
|
$
|
145,747
|
|
|
|
|
|
|
|
|
$
|
166,038
|
|
||||||||||||
Short-term investments
|
|
|
|
|
|
|
50,688
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||||
Long-term investments
|
|
|
|
|
|
|
1,751
|
|
|
|
|
|
|
|
|
—
|
|
||||||||||||||
Total cash equivalents and available-for-sale securities
|
|
|
|
|
|
|
$
|
198,186
|
|
|
|
|
|
|
|
|
$
|
166,038
|
|
|
December 31,
|
||
|
2015
|
|
2014
|
Due within one year
|
$50,688
|
|
$—
|
Due between one and two years
|
1,751
|
|
—
|
Total
|
$52,439
|
|
$—
|
|
As of December 31, 2015
|
||||||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
145,747
|
|
|
$
|
145,747
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. government agency obligations
|
52,439
|
|
|
—
|
|
|
52,439
|
|
|
$
|
—
|
|
|||
Total assets measured at fair value
|
$
|
198,186
|
|
|
$
|
145,747
|
|
|
$
|
52,439
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Derivative liabilities associated with the Medicis settlement
|
$
|
1,414
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,414
|
|
Total liabilities measured at fair value
|
$
|
1,414
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,414
|
|
|
As of December 31, 2014
|
||||||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
166,038
|
|
|
$
|
166,038
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets measured at fair value
|
$
|
166,038
|
|
|
$
|
166,038
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Derivative liabilities associated with the Medicis settlement
|
$
|
1,541
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,541
|
|
Total liabilities measured at fair value
|
$
|
1,541
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,541
|
|
|
|
Derivative
Liability
Associated with
the Medicis
Settlement
|
||
Fair value as of December 31, 2014
|
|
1,541
|
|
|
Change in fair value
|
|
(127
|
)
|
|
Fair value as of December 31, 2015
|
|
$
|
1,414
|
|
|
As of December 31,
|
||||||
|
2015
|
|
2014
|
||||
Research equipment
|
$
|
12,053
|
|
|
$
|
10,914
|
|
Computer equipment
|
879
|
|
|
477
|
|
||
Furniture and fixtures
|
604
|
|
|
534
|
|
||
Leasehold improvements
|
4,164
|
|
|
3,833
|
|
||
Construction in progress
|
13,480
|
|
|
13,422
|
|
||
Total property and equipment
|
31,180
|
|
|
29,180
|
|
||
Less: accumulated depreciation and amortization
|
(11,472
|
)
|
|
(9,906
|
)
|
||
Property and equipment, net
|
$
|
19,708
|
|
|
$
|
19,274
|
|
|
As of December 31,
|
||||||
|
2015
|
|
2014
|
||||
Prepaid expenses
|
$
|
1,200
|
|
|
$
|
1,085
|
|
Accounts receivable and other receivables
|
158
|
|
|
300
|
|
||
Other current assets
|
267
|
|
|
239
|
|
||
Total prepaid expenses and other current assets
|
$
|
1,625
|
|
|
$
|
1,624
|
|
|
As of December 31,
|
||||||
|
2015
|
|
2014
|
||||
Accrued compensation
|
$
|
3,282
|
|
|
$
|
2,088
|
|
Accrued professional service fees
|
471
|
|
|
577
|
|
||
Accrued manufacturing and quality control costs
|
207
|
|
|
361
|
|
||
Accrued clinical trial expenses
|
1,300
|
|
|
322
|
|
||
Accrued fixed assets
|
262
|
|
|
266
|
|
||
Accrued construction-in-progress obligations
|
25
|
|
|
60
|
|
||
Accrued interest on notes payable
|
—
|
|
|
23
|
|
||
Other current liabilities
|
698
|
|
|
448
|
|
||
Total accruals and other current liabilities
|
$
|
6,245
|
|
|
$
|
4,145
|
|
Year Ending December 31,
|
|
|
2016
|
4,217
|
|
2017
|
3,936
|
|
2018
|
949
|
|
Total payments
|
9,102
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Interest expense
|
|
|
|
|
|
||||||
Cash related interest expense (1)
|
$
|
(802
|
)
|
|
$
|
(1,182
|
)
|
|
$
|
(1,590
|
)
|
|
|
|
|
|
|
||||||
Non-cash interest expense
|
|
|
|
|
|
||||||
Non-cash interest expense — debt issuance costs
|
(39
|
)
|
|
(203
|
)
|
|
(490
|
)
|
|||
Non-cash interest expense — warrant and derivative related debt discounts
|
(5
|
)
|
|
(650
|
)
|
|
(4,128
|
)
|
|||
Non-cash interest expense — convertible notes
|
—
|
|
|
(1,250
|
)
|
|
(9,409
|
)
|
|||
Loss on extinguishment of 2013 Notes
|
—
|
|
|
(8,331
|
)
|
|
—
|
|
|||
Effective interest on financing obligation
|
(344
|
)
|
|
(28
|
)
|
|
—
|
|
|||
Capitalized interest expense (2)
|
—
|
|
|
972
|
|
|
453
|
|
|||
Total non-cash interest expense
|
(388
|
)
|
|
(9,490
|
)
|
|
(13,574
|
)
|
|||
|
|
|
|
|
|
||||||
Total interest expense
|
$
|
(1,190
|
)
|
|
$
|
(10,672
|
)
|
|
$
|
(15,164
|
)
|
(1)
|
Cash related interest expense included interest payments to Hercules Notes Payable and Essex Notes.
|
(2)
|
Interest expense capitalized pursuant to Accounting Standards Codification Topic 835,
Interest
.
|
|
As of December 31,
|
||||
|
2015
|
|
2014
|
||
Issuances under stock incentive plans
|
273,948
|
|
|
91,634
|
|
Issuances upon exercise of common stock warrants
|
61,595
|
|
|
198,662
|
|
Issuances under employee stock purchase plan
|
396,660
|
|
|
174,661
|
|
Issuances under inducement plan
|
449,889
|
|
|
141,500
|
|
|
1,182,092
|
|
|
606,457
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Net loss
|
$
|
(73,476
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
(52,448
|
)
|
Capital contribution on the extinguishment of prior convertible preferred stock
|
—
|
|
|
—
|
|
|
74,894
|
|
|||
Deemed dividend on the issuance of Series E-5 convertible preferred stock
|
—
|
|
|
—
|
|
|
(177
|
)
|
|||
Noncumulative dividend on Series E convertible preferred stock
|
—
|
|
|
—
|
|
|
(13,878
|
)
|
|||
Undistributed earnings allocated to preferred stockholders
|
—
|
|
|
—
|
|
|
(8,133
|
)
|
|||
Net income (loss) attributable to common stockholders, basic
|
(73,476
|
)
|
|
(62,917
|
)
|
|
258
|
|
|||
Adjustments to net income (loss) for dilutive securities
|
—
|
|
|
—
|
|
|
825
|
|
|||
Net income (loss) attributable to common stockholders, diluted
|
$
|
(73,476
|
)
|
|
$
|
(62,917
|
)
|
|
$
|
1,083
|
|
Net income (loss) per share attributable to common stockholders
|
|
|
|
|
|
||||||
Basic
|
$
|
(3.02
|
)
|
|
$
|
(3.24
|
)
|
|
$
|
1.17
|
|
Diluted
|
$
|
(3.02
|
)
|
|
$
|
(3.24
|
)
|
|
$
|
1.05
|
|
Weighted-average shares used in computing net income (loss) per share attributable to common stockholders:
|
|
|
|
|
|
||||||
Basic
|
24,340,466
|
|
|
19,391,523
|
|
|
220,220
|
|
|||
Stock options
|
—
|
|
|
—
|
|
|
167,655
|
|
|||
Warrants to purchase common stock
|
—
|
|
|
—
|
|
|
641,275
|
|
|||
Diluted
|
24,340,466
|
|
|
19,391,523
|
|
|
1,029,150
|
|
|
As of December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Stock options
|
2,420,105
|
|
|
1,818,323
|
|
|
—
|
|
Convertible preferred stock
|
—
|
|
|
—
|
|
|
8,689,999
|
|
Convertible preferred stock warrants
|
—
|
|
|
—
|
|
|
184,486
|
|
Common stock warrants
|
61,595
|
|
|
198,662
|
|
|
—
|
|
Unvested restricted stock awards
|
315,600
|
|
|
251,325
|
|
|
—
|
|
|
Number of
Shares
Available
for Grant
|
|
Number of
Shares
Underlying
Outstanding
Options
|
|
Weighted
Average
Exercise
Price Per
Share
|
|
Weighted
Average
Remaining
Contractual
Life (in
Years)
|
|
Aggregate
Intrinsic
Value
|
|||||||
|
|
|
|
|
|
|
|
|
(In thousands)
|
|||||||
Balance as of December 31, 2012
|
32,985
|
|
|
306,317
|
|
|
$
|
3.45
|
|
|
—
|
|
|
$
|
—
|
|
Additional shares reserved
|
1,080,661
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||
Options granted
|
(992,213
|
)
|
|
992,213
|
|
|
8.80
|
|
|
|
|
|
||||
Options exercised
|
—
|
|
|
(4,340
|
)
|
|
2.55
|
|
|
|
|
|
||||
Options cancelled/forfeited
|
81,125
|
|
|
(81,125
|
)
|
|
6.42
|
|
|
|
|
|
||||
Balance as of December 31, 2013
|
202,558
|
|
|
1,213,065
|
|
|
7.65
|
|
|
|
|
|
||||
Additional shares reserved
|
1,000,000
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||
Options granted
|
(728,349
|
)
|
|
728,349
|
|
|
30.21
|
|
|
|
|
|
||||
Awards granted
|
(212,450
|
)
|
|
212,450
|
|
|
—
|
|
|
|
|
|
||||
Options exercised
|
—
|
|
|
(238,999
|
)
|
|
5.96
|
|
|
|
|
|
||||
Options cancelled/forfeited
|
14,600
|
|
|
(14,600
|
)
|
|
26.89
|
|
|
|
|
|
||||
Awards forfeited
|
4,500
|
|
|
(4,500
|
)
|
|
—
|
|
|
|
|
|
||||
Shares cancelled/retired under 2002/2012 plans
|
(189,225
|
)
|
|
(9,617
|
)
|
|
—
|
|
|
|
|
|
||||
Balance as of December 31, 2014
|
91,634
|
|
|
1,886,148
|
|
|
17.90
|
|
|
|
|
|
||||
Additional shares reserved
|
950,978
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||
Options granted
|
(747,338
|
)
|
|
747,338
|
|
|
18.94
|
|
|
|
|
|
||||
Awards granted
|
(169,336
|
)
|
|
169,336
|
|
|
—
|
|
|
|
|
|
||||
Options exercised
|
—
|
|
|
(205,735
|
)
|
|
11.84
|
|
|
|
|
|
||||
Options cancelled/forfeited
|
116,540
|
|
|
(116,540
|
)
|
|
21.33
|
|
|
|
|
|
||||
Awards forfeited
|
24,306
|
|
|
(24,306
|
)
|
|
—
|
|
|
|
|
|
||||
Awards released
|
—
|
|
|
(74,755
|
)
|
|
—
|
|
|
|
|
|
||||
Shares cancelled/retired under 2002/2012 plans
|
(19,276
|
)
|
|
—
|
|
|
—
|
|
|
|
|
|
||||
Shares traded for taxes
|
26,440
|
|
|
—
|
|
|
—
|
|
|
|
|
|
||||
Balance as of December 31, 2015
|
273,948
|
|
|
2,381,486
|
|
|
$
|
18.36
|
|
|
8.1
|
|
|
$
|
33,274
|
|
Options vested and expected to vest as of December 31, 2015
|
|
|
2,070,287
|
|
|
$
|
18.28
|
|
|
8.0
|
|
|
$
|
32,926
|
|
|
Exercisable as of December 31, 2015
|
|
|
870,911
|
|
|
$
|
16.30
|
|
|
7.4
|
|
|
$
|
15,558
|
|
|
Number of
Shares Available for Grant |
|
Number of
Shares Underlying Outstanding Options and Awards |
|
Weighted
Average Exercise Price Per Share |
|
Weighted
Average Remaining Contractual Life (in Years) |
|
Aggregate
Intrinsic Value |
|||||||
|
|
|
|
|
|
|
|
|
(In thousands)
|
|||||||
Shares reserved
|
325,000
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
Options granted
|
(140,125
|
)
|
|
140,125
|
|
|
$
|
22.52
|
|
|
|
|
|
|||
Restricted stock awards granted
|
(43,375
|
)
|
|
43,375
|
|
|
$
|
—
|
|
|
|
|
|
|||
Outstanding as of December 31, 2014
|
141,500
|
|
|
183,500
|
|
|
$
|
22.52
|
|
|
|
|
$
|
—
|
|
|
Additional shares reserved
|
500,000
|
|
|
|
|
|
|
|
|
|
||||||
Options granted
|
(206,250
|
)
|
|
206,250
|
|
|
$
|
36.32
|
|
|
|
|
|
|||
Restricted stock awards granted
|
(34,375
|
)
|
|
34,375
|
|
|
—
|
|
|
|
|
|
||||
Option forfeitures
|
29,531
|
|
|
(29,531
|
)
|
|
$
|
22.97
|
|
|
|
|
|
|||
Award forfeitures
|
9,843
|
|
|
(9,843
|
)
|
|
$
|
—
|
|
|
|
|
|
|||
Awards released
|
—
|
|
|
(30,532
|
)
|
|
$
|
—
|
|
|
|
|
|
|||
Traded for taxes
|
9,640
|
|
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|||
Outstanding as of December 31, 2015
|
449,889
|
|
|
354,219
|
|
|
$
|
31.46
|
|
|
7.2
|
|
|
$
|
1,300
|
|
Options vested and expected to vest as of December 31, 2015
|
|
|
314,221
|
|
|
$
|
31.49
|
|
|
7.1
|
|
|
$
|
1,281
|
|
|
Exercisable as of December 31, 2015
|
|
|
95,469
|
|
|
$
|
22.77
|
|
|
0.9
|
|
|
$
|
1,088
|
|
|
Number of
Awards Available for Grant |
|
Weighted-Average Grant-Date Fair Value
|
|
Aggregate
Intrinsic Value |
|||||
|
|
|
|
|
(In thousands)
|
|||||
Outstanding as of December 31, 2013
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Granted
|
255,825
|
|
|
29.47
|
|
|
—
|
|
||
Vested
|
—
|
|
|
—
|
|
|
—
|
|
||
Forfeited
|
(4,500
|
)
|
|
26.89
|
|
|
—
|
|
||
Outstanding as of December 31, 2014
|
251,325
|
|
|
$
|
29.51
|
|
|
—
|
|
|
Granted
|
203,711
|
|
|
21.55
|
|
|
—
|
|
||
Vested
|
(105,287
|
)
|
|
27.79
|
|
|
—
|
|
||
Forfeited
|
(34,149
|
)
|
|
22.77
|
|
|
—
|
|
||
Outstanding as of December 31, 2015
|
315,600
|
|
|
$
|
25.67
|
|
|
$
|
10,781
|
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Expected term (in years)
|
6.0
|
|
|
6.0
|
|
|
6.0
|
|
Expected volatility
|
62.2
|
%
|
|
57.4
|
%
|
|
59.1
|
%
|
Risk-free interest rate
|
1.6
|
%
|
|
1.9
|
%
|
|
1.3
|
%
|
Expected dividend rate
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Expected term (in years)
|
8.2
|
|
|
7.3
|
|
|
9.0
|
|
Expected volatility
|
73.0
|
%
|
|
56.1
|
%
|
|
58.8
|
%
|
Risk-free interest rate
|
2.0
|
%
|
|
2.1
|
%
|
|
2.7
|
%
|
Expected dividend rate
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
Year Ended December 31,
|
||||
|
2015
|
|
2014
|
||
Expected term (in years)
|
0.5
|
|
|
0.5
|
|
Expected volatility
|
63.4
|
%
|
|
46.8
|
%
|
Risk-free interest rate
|
0.2
|
%
|
|
0.1
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
Year Ended December 31,
|
||||||||||
2015
|
|
2014
|
|
2013
|
|||||||
Research and development
|
$
|
6,511
|
|
|
$
|
2,357
|
|
|
$
|
194
|
|
General and administrative
|
5,877
|
|
|
4,173
|
|
|
354
|
|
|||
Total stock-based compensation expense
|
$
|
12,388
|
|
|
$
|
6,530
|
|
|
$
|
548
|
|
|
Year Ended December 31,
|
||||||
|
2015
|
|
2014
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carryforward
|
$
|
115,949
|
|
|
$
|
92,859
|
|
Accruals and reserves
|
2,371
|
|
|
2,458
|
|
||
Stock based compensation
|
3,367
|
|
|
1,602
|
|
||
Tax credits
|
3,311
|
|
|
2,623
|
|
||
Fixed and intangible assets
|
4,935
|
|
|
5,223
|
|
||
Valuation Allowance
|
(129,933
|
)
|
|
(104,765
|
)
|
||
Total deferred tax assets
|
—
|
|
|
—
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Debt discount
|
—
|
|
|
—
|
|
||
Total deferred tax liabilities
|
—
|
|
|
—
|
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Tax (benefit) at statutory federal rate
|
$
|
(24,982
|
)
|
|
$
|
(21,392
|
)
|
|
$
|
(17,832
|
)
|
State Tax (benefit) — net of federal benefit
|
—
|
|
|
79
|
|
|
849
|
|
|||
Permanent differences
|
224
|
|
|
660
|
|
|
3,931
|
|
|||
Debt discount
|
—
|
|
|
756
|
|
|
2,888
|
|
|||
Research and development credits
|
(516
|
)
|
|
3,137
|
|
|
(642
|
)
|
|||
Other
|
607
|
|
|
537
|
|
|
284
|
|
|||
Change in valuation allowance
|
$
|
24,667
|
|
|
$
|
16,226
|
|
|
$
|
10,522
|
|
Provision for taxes
|
$
|
—
|
|
|
$
|
3
|
|
|
$
|
—
|
|
|
Unrecognized tax benefits
|
||
Balance as of December 31, 2012
|
2,012
|
|
|
Additions for current tax positions
|
276
|
|
|
Balance as of December 31, 2013
|
2,288
|
|
|
Decrease for prior tax positions
|
(1,216
|
)
|
|
Additions for current tax positions
|
196
|
|
|
Balance as of December 31, 2014
|
1,268
|
|
|
Additions for prior tax positions
|
10
|
|
|
Additions for current tax positions
|
$
|
259
|
|
Balance as of December 31, 2015
|
$
|
1,537
|
|
|
For the Quarters Ended
|
||||||||||||||
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
|
2015
|
||||||||||||||
Revenue
|
$
|
75
|
|
|
$
|
75
|
|
|
$
|
75
|
|
|
$
|
75
|
|
Net loss
|
$
|
(15,402
|
)
|
|
$
|
(16,805
|
)
|
|
$
|
(19,175
|
)
|
|
$
|
(22,094
|
)
|
Net income (loss) attributable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(15,402
|
)
|
|
$
|
(16,805
|
)
|
|
$
|
(19,175
|
)
|
|
$
|
(22,094
|
)
|
Diluted
|
$
|
(15,402
|
)
|
|
$
|
(16,805
|
)
|
|
$
|
(19,175
|
)
|
|
$
|
(22,094
|
)
|
Net income (loss) per share attributable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.65
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(0.81
|
)
|
|
$
|
(0.83
|
)
|
Diluted
|
$
|
(0.65
|
)
|
|
$
|
(0.71
|
)
|
|
$
|
(0.81
|
)
|
|
$
|
(0.83
|
)
|
|
|
|
|
|
|
|
|
||||||||
|
2014
|
||||||||||||||
Revenue
|
$
|
158
|
|
|
$
|
75
|
|
|
$
|
75
|
|
|
$
|
75
|
|
Net loss
|
$
|
(21,426
|
)
|
|
$
|
(13,302
|
)
|
|
$
|
(13,977
|
)
|
|
$
|
(14,212
|
)
|
Net income (loss) attributable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(21,426
|
)
|
|
$
|
(13,302
|
)
|
|
$
|
(13,977
|
)
|
|
$
|
(14,212
|
)
|
Diluted
|
$
|
(21,426
|
)
|
|
$
|
(13,302
|
)
|
|
$
|
(13,977
|
)
|
|
$
|
(14,212
|
)
|
Net income (loss) per share attributable to common stockholders:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(1.93
|
)
|
|
$
|
(0.69
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
(0.60
|
)
|
Diluted
|
$
|
(1.93
|
)
|
|
$
|
(0.69
|
)
|
|
$
|
(0.60
|
)
|
|
$
|
(0.60
|
)
|
REVANCE THERAPEUTICS, INC.
|
||
|
|
|
By:
|
|
/s/ L. Daniel Browne
|
|
|
L. Daniel Browne
|
|
|
President and Chief Executive Officer
|
Signatures
|
Title
|
Date
|
|
|
|
/s/ L. Daniel Browne
|
President, Chief Executive
|
March 4, 2016
|
L. Daniel Browne
|
Officer and Director
|
|
|
(Principal Executive Officer)
|
|
|
|
|
/s/ Lauren P. Silvernail
|
Chief Financial Officer and
|
March 4, 2016
|
Lauren P. Silvernail
|
Chief Business Officer
|
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
/s/ Angus C. Russell
|
Director, Chairman
|
March 4, 2016
|
Angus C. Russell
|
|
|
|
|
|
/s/ Robert Byrnes
|
Director
|
March 4, 2016
|
Robert Byrnes
|
|
|
|
|
|
/s/ Ronald W. Eastman
|
Director
|
March 4, 2016
|
Ronald W. Eastman
|
|
|
|
|
|
/s/ Phyllis Gardner
|
Director
|
March 4, 2016
|
Phyllis Gardner, M.D.
|
|
|
Signatures
|
Title
|
Date
|
|
|
|
/s/ James Glasheen
|
Director
|
March 4, 2016
|
James Glasheen, Ph.D.
|
|
|
|
|
|
/s/ Mark A. Prygocki, Sr.
|
Director
|
March 4, 2016
|
Mark A. Prygocki, Sr.
|
|
|
|
|
|
/s/ Jonathan Tunnicliffe
|
Director
|
March 4, 2016
|
Jonathan Tunnicliffe
|
|
|
|
|
|
/s/ Philip J. Vickers
|
Director
|
March 4, 2016
|
Philip J. Vickers, Ph.D.
|
|
|
|
|
|
/s/ Ronald Wooten
|
Director
|
March 4, 2016
|
Ronald Wooten
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Form
|
|
File No.
|
|
Incorporated
by
Reference
|
|
Exhibit Filing Date
|
|
Filed
Herewith
|
3.1
|
|
Amended and Restated Certificate of Incorporation
|
|
8-K
|
|
001-36297
|
|
3.1
|
|
February 11, 2014
|
|
|
3.2
|
|
Amended and Restated Bylaws
|
|
S-1
|
|
333-193154
|
|
3.4
|
|
December 31, 2013
|
|
|
4.1
|
|
Amended and Restated Investor Rights Agreement, effective as of February 5, 2014, among Revance Therapeutics, Inc. and certain of its stockholders
|
|
S-1/A
|
|
333-193154
|
|
4.3
|
|
January 27, 2014
|
|
|
4.2
|
|
Form of Common Stock Certificate
|
|
S-1/A
|
|
333-193154
|
|
4.4
|
|
February 3, 2014
|
|
|
10.1 *
|
|
Revance Therapeutics, Inc. 2002 Equity Incentive Plan
|
|
S-1
|
|
333-193154
|
|
10.1
|
|
December 31, 2013
|
|
|
10.2 *
|
|
Form of Stock Option Agreement and Option Grant Notice for Revance Therapeutics, Inc. 2002 Equity Incentive Plan
|
|
S-1
|
|
333-193154
|
|
10.2
|
|
December 31, 2013
|
|
|
10.3 *
|
|
Revance Therapeutics, Inc. Amended and Restated 2012 Equity Incentive Plan
|
|
S-1
|
|
333-193154
|
|
10.3
|
|
December 31, 2013
|
|
|
10.4 *
|
|
Form of Stock Option Agreement and Option Grant Notice for Revance Therapeutics, Inc. Amended and Restated 2012 Equity Incentive Plan
|
|
S-1
|
|
333-193154
|
|
10.4
|
|
December 31, 2013
|
|
|
10.5 *
|
|
Revance Therapeutics, Inc. 2014 Equity Incentive Plan
|
|
S-1/A
|
|
333-193154
|
|
10.5
|
|
January 27, 2014
|
|
|
10.6 *
|
|
Form of Restricted Stock Unit Award Agreement and Grant Notice for Revance Therapeutics, Inc. 2014 Equity Incentive Plan
|
|
|
|
|
|
|
|
|
|
X
|
10.7*
|
|
Form of Stock Option Agreement and Grant Notice for Revance Therapeutics, Inc. 2014 Equity Incentive Plan
|
|
10-Q
|
|
001-36297
|
|
10.3
|
|
November 10, 2015
|
|
|
10.8*
|
|
Form of Restricted Stock Bonus Agreement and Grant Notice for Revance Therapeutics, Inc. 2014 Equity Incentive Plan
|
|
|
|
|
|
|
|
|
|
X
|
10.9*
|
|
Revance Therapeutics, Inc. 2014 Employee Stock Purchase Plan
|
|
S-1/A
|
|
333-193154
|
|
10.7
|
|
January 27, 2014
|
|
|
10.10*
|
|
Form of Indemnity Agreement by and between Revance Therapeutics, Inc. and each of its officers and directors
|
|
S-1/A
|
|
333-193154
|
|
10.8
|
|
January 27, 2014
|
|
|
10.11
|
|
Lease Agreement dated March 31, 2008 by and between Revance Therapeutics, Inc. and BMR-Gateway Boulevard LLC
|
|
S-1
|
|
333-193154
|
|
10.9
|
|
December 31, 2013
|
|
|
10.12
|
|
First Amendment to Office Lease dated April 7, 2008 by and between Revance Therapeutics, Inc. and BMR-Gateway Boulevard LLC
|
|
S-1
|
|
333-193154
|
|
10.1
|
|
December 31, 2013
|
|
|
10.13
|
|
Second Amendment to Office Lease and Lease dated May 17, 2010 by and between Revance Therapeutics, Inc. and BMR-Gateway Boulevard LLC
|
|
S-1
|
|
333-193154
|
|
10.11
|
|
December 31, 2013
|
|
|
10.14
|
|
Third Amendment to Lease, dated February 26, 2014 by and between Revance Therapeutics, Inc. and BMR-Gateway Boulevard LLC
|
|
8-K
|
|
001-36297
|
|
10.35
|
|
March 4, 2014
|
|
|
10.15+
|
|
License and Service Agreement dated February 8, 2007 between Revance Therapeutics, Inc. and List Biological Laboratories, Inc.
|
|
S-1
|
|
333-193154
|
|
10.15
|
|
December 31, 2013
|
|
|
10.16+
|
|
First Addendum to the License and Service Agreement dated April 21, 2009 between Revance Therapeutics, Inc. and List Biological Laboratories, Inc.
|
|
S-1
|
|
333-193154
|
|
10.16
|
|
December 31, 2013
|
|
|
10.17+
|
|
Development, Manufacturing and Supply Agreement dated April 30, 2010 between Revance Therapeutics, Inc. and Duoject Medical Systems Inc.
|
|
S-1
|
|
333-193154
|
|
10.17
|
|
December 31, 2013
|
|
|
10.18+
|
|
First Amendment to Development, Manufacturing and Supply Agreement dated April 30, 2010 between Revance Therapeutics, Inc. and Duoject Medical Systems Inc.
|
|
10-Q
|
|
001-36297
|
|
10.4
|
|
May 14, 2015
|
|
|
10.19+
|
|
Development and Supply Agreement dated December 11, 2009 between Revance Therapeutics, Inc. and Hospira Worldwide, Inc.
|
|
S-1
|
|
333-193154
|
|
10.18
|
|
December 31, 2013
|
|
|
10.20+
|
|
First Amendment to Development and Supply Agreement dated May 29, 2013 between Revance Therapeutics, Inc. and Hospira Worldwide, Inc
|
|
S-1
|
|
333-193154
|
|
10.2
|
|
December 31, 2013
|
|
|
10.21+
|
|
Second Amendment to Development and Supply Agreement dated August 31, 2015 between Revance Therapeutics, Inc. and Hospira Worldwide, Inc.
|
|
10-Q
|
|
001-36297
|
|
10.1
|
|
November 10, 2015
|
|
|
10.22+
|
|
Manufacture and Development Agreement dated May 20, 2013 between Revance Therapeutics, Inc. and American Peptide Company, Inc.
|
|
S-1
|
|
333-193154
|
|
10.19
|
|
December 31, 2013
|
|
|
10.23
|
|
Loan and Lease Agreement dated as of December 20, 2013 by and between Revance Therapeutics, Inc. and Essex Capital Corporation
|
|
S-1
|
|
333-193154
|
|
10.21
|
|
December 31, 2013
|
|
|
10.24
|
|
First Amendment to Loan and Lease Agreement, dated December 17, 2014, by and between Revance Therapeutics, Inc. and Essex Capital Corporation
|
|
8-K
|
|
001-36297
|
|
10.1
|
|
December 22, 2014
|
|
|
10.25
|
|
Second Amendment to Loan and Lease Agreement, dated February 26, 2015, by and between Revance Therapeutics, Inc. and Essex Capital Corporation
|
|
10-Q
|
|
001-36297
|
|
10.4
|
|
May 14, 2015
|
|
|
10.26*
|
|
Revance Therapeutics, Inc. Amended and Restated Executive Severance Benefit Plan
|
|
8-K
|
|
333-193154
|
|
10.1
|
|
May 13, 2015
|
|
|
10.27*
|
|
Revance Therapeutics, Inc. Amended and Restated Non-Employee Director Compensation Policy
|
|
|
|
|
|
|
|
|
|
X
|
10.28*
|
|
Revance Therapeutics, Inc. 2016 Management Bonus Plan
|
|
|
|
|
|
|
|
|
|
X
|
10.29*
|
|
Revance Therapeutics, Inc. Amended and Restated 2014 Inducement Plan
|
|
8-K
|
|
001-36297
|
|
99.1
|
|
December 14, 2015
|
|
|
10.30*
|
|
Form of Stock Option Agreement and Grant Notice under Amended and Restated Revance Therapeutics, Inc. 2014 Inducement Plan
|
|
10-Q
|
|
001-36297
|
|
10.5
|
|
November 10, 2015
|
|
|
10.31*
|
|
Form of Restricted Stock Agreement and Grant Notice under Amended and Restated
Revance Therapeutics, Inc. 2014 Inducement Plan
|
|
|
|
|
|
|
|
|
|
X
|
10.32*
|
|
Executive Employment Agreement dated December 30, 2013 by and between Revance Therapeutics, Inc. and L. Daniel Browne
|
|
S-1/A
|
|
333-193154
|
|
10.25
|
|
January 27, 2014
|
|
|
10.33*
|
|
Executive Employment Agreement dated December 31, 2013 by and between Revance Therapeutics, Inc. and Lauren Silvernail
|
|
S-1/A
|
|
333-193154
|
|
10.27
|
|
January 27, 2014
|
|
|
10.34*
|
|
Executive Employment Agreement dated December 14, 2015 by and between Revance Therapeutics, Inc. and Abhay Joshi.
|
|
|
|
|
|
|
|
|
|
X
|
21.1
|
|
List of Subsidiaries of the Registrant
|
|
|
|
|
|
|
|
|
|
X
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm
|
|
|
|
|
|
|
|
|
|
X
|
24.1
|
|
Power of Attorney (contained in the signature page to this Annual Report on Form 10-K)
|
|
|
|
|
|
|
|
|
|
X
|
31.1
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) promulgated under the Exchange Act
|
|
|
|
|
|
|
|
|
|
X
|
31.2
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) promulgated under the Exchange Act
|
|
|
|
|
|
|
|
|
|
X
|
32.1†
|
|
Certification of the Chief Executive Officer pursuant to18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
|
|
|
|
X
|
32.2†
|
|
Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
|
|
|
X
|
101.INS**
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
X
|
101.SCH**
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
|
X
|
101.CAL**
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.DEF**
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.LAB**
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.PRE**
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
*
|
Indicates a management contract or compensatory plan or arrangement.
|
+
|
Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
†
|
The certifications attached as Exhibit 32.1 and 32.2 that accompany this Annual Report on Form 10-K are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Revance Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-K, irrespective of any general incorporation language contained in such filing.
|
**
|
Users of this data are advised that, pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability under these sections.
|
Issuance Schedule:
|
|
Subject to any change on a Capitalization Adjustment, one share of Common Stock will be issued for each Restricted Stock Unit that vests at the time set forth in Section 6 of the Award Agreement.
|
R
EVANCE
T
HERAPEUTICS
, I
NC
.
|
||
|
|
|
By:
|
|
|
|
|
Signature
|
|
|
|
Title:
|
|
|
|
|
|
Date:
|
|
|
COMPANY:
|
|
Revance Therapeutics, Inc.
|
|
|
Attn: Stock Administrator
|
|
|
7555 Gateway Boulevard
|
|
|
Newark, CA 94560
|
|
|
|
PARTICIPANT:
|
|
Your address as on file with the Company
|
|
|
at the time notice is given
|
|
|
|
|
|
|
|
|
Participant:
|
|
|
|
|
Date of Grant:
|
|
|
|
|
Vesting Commencement Date:
|
|
15th day of the calendar month immediately following the month in which this Award is granted
|
|
|
Number of Shares Subject to Award:
|
|
|
|
|
Consideration:
|
|
Participant’s Services
|
|
|
|
|
|
R
EVANCE
T
HERAPEUTICS
, I
NC
.
|
||
|
|
|
By:
|
|
|
|
|
Signature
|
|
|
|
Title:
|
|
|
|
|
|
Date:
|
|
|
COMPANY:
|
Revance Therapeutics, Inc
|
|
7555 Gateway Boulevard
|
|
Newark, California 94560
|
|
Attn: [General Counsel]
|
|
|
RECIPIENT:
|
_________________________________
|
|
_________________________________
|
|
_________________________________
|
|
_________________________________
|
|
|
ESCROW AGENT:
|
Revance Therapeutics, Inc
|
|
7555 Gateway Boulevard
|
|
Newark, California 94560
|
|
Attn: Corporate Secretary
|
|
|
Very truly yours,
|
||
|
|
|
|
|
|
|
REVANCE THERAPEUTICS, INC
|
||
|
|
|
|
|
|
|
By:
|
|
|
|
|
|
|
|
|
|
RECIPIENT
|
||
|
|
|
|
|
|
|
______________________________________________________
|
||
|
|
|
|
|
|
|
Name:____________________________________________
|
||
|
|
|
|
|
ESCROW AGRENT:
|
|
|
|
|
|
|
|
|
|
____________________________________
|
|
|
|
Dated:___________________________
|
|
|
|
|
|
|
|
|
|
|
|
Signatures:_________________________________________
|
||
|
|
[Participant's Name], Recipient
|
1.
|
Annual Board Service Retainer
:
|
3.
|
Annual Committee Chair Service Retainer (including Committee Member Service Retainer)
:
|
Participant:
|
__________________________________________________________
|
Date of Grant:
|
__________________________________________________________
|
Vesting Commencement Date:
|
15th day of the calendar month immediately following the month in which this award is granted
|
Number of Shares Subject to Award
|
__________________________________________________________
|
Consideration
|
Participant's Future Services
|
REVANCE THERAPEUTICS, INC.
|
PARTICIPANT:
|
|
|
By:__________________________________________
|
[Name]
|
Signature
|
|
|
|
Title:_________________________________________
|
_____________________________________________
|
|
Signature
|
|
|
Date:_________________________________________
|
Date:_________________________________________
|
COMPANY:
|
Revance Therapeutics, Inc
|
|
7555 Gateway Boulevard
|
|
Newark, California 94560
|
|
Attn: [General Counsel]
|
|
|
RECIPIENT:
|
_________________________________
|
|
_________________________________
|
|
_________________________________
|
|
_________________________________
|
|
|
ESCROW AGENT:
|
Revance Therapeutics, Inc
|
|
7555 Gateway Boulevard
|
|
Newark, California 94560
|
|
Attn: Corporate Secretary
|
|
|
Very truly yours,
|
||
|
|
|
|
|
|
|
REVANCE THERAPEUTICS, INC
|
||
|
|
|
|
|
|
|
By:
|
|
|
|
|
|
|
|
|
|
RECIPIENT
|
||
|
|
|
|
|
|
|
______________________________________________________
|
||
|
|
|
|
|
|
|
Name:____________________________________________
|
||
|
|
|
|
|
ESCROW AGRENT:
|
|
|
|
|
|
|
|
|
|
____________________________________
|
|
|
|
Dated:___________________________
|
|
|
|
|
|
|
|
|
|
|
|
Signature:_________________________________________
|
||
|
|
[Participant's Name], Recipient
|
|
|
REVANCE THERAPEUTICS, INC
|
||
|
|
|
|
|
|
|
By:
/s/Dan Browne____________________________
|
||
|
|
Dan Browne
|
|
|
|
|
President & Cheif Executive Officer
|
||
|
|
|
|
|
|
|
EXECUTIVE
|
||
|
|
|
|
|
|
|
/s/ Abbay Joshi________________________________
|
||
|
|
Abbay Joshi, PhD, MBA
|
/s/ L. Daniel Browne
|
|
L. Daniel Browne
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
/s/ Lauren P. Silvernail
|
|
Lauren P. Silvernail
|
|
Chief Financial Officer and Chief Business Officer
|
|
(Principal Financial Officer)
|
|
1.
|
The Company’s Annual Report on Form 10-K for the period ended December 31, 2015 (the “Annual Report”), to which this Certification is attached as Exhibit 32.1, fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
|
2.
|
The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ L. Daniel Browne
|
|
L. Daniel Browne
|
|
President and Chief Executive Officer
|
|
1.
|
The Company’s Annual Report on Form 10-K for the period ended December 31, 2015 (the “Annual Report”), to which this Certification is attached as Exhibit 32.2, fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
|
2.
|
The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Lauren P. Silvernail
|
|
Lauren P. Silvernail
|
|
Chief Financial Officer and Chief Business Officer
|
|