Evolus Reports Fourth Quarter and Full Year 2018 Results
Received U.S. FDA Approval of Jeuveau™ on
Majority of Sales Force Hired with Launch Planned in the Coming Weeks
Hosting Investor & Analyst Day on
Recent Company Highlights:
Received U.S. Food and Drug Administration(“FDA”) approval for Jeuveau™ on February 1, 2019
- Unveiled the TRANSPARENCY global clinical program which includes the largest head-to-head aesthetic pivotal trial versus Botox®, expected to be published in the second quarter of 2019
- Announced Project FUSE which is designed to catapult Jeuveau™ to the number two U.S. market share position within twenty-four months of launch
Crystal MuilenburgVice President, Corporate Communications and Public Relations
- Secured a
$100 millionsenior debt facility with Oxford Finance LLCand drew $75 millionupon close
Mr. Moatazedi continued, “In addition to our U.S. launch, we expect to receive an opinion from the CHMP in the coming weeks. The highly anticipated publication of our U.S. Phase III trial data and EU /
Fourth Quarter and Full Year 2018 Financial Results
Operating expenses for the fourth quarter ended
Non-GAAP operating expense for the fourth quarter ended December 31, 2018 was $11.5 million and was calculated as operating expense excluding stock-based compensation of $1.9 million and a gain of
Net loss for the fourth quarter ended
Total cash was
Conference Call Information
Management will host a conference call and webcast to discuss
A replay of the call will be available following its completion through
A live audio webcast of the call will be available on the Investor Relations page of the
Investor & Analyst Day Information
Interested parties can access management’s slide presentation and a live audio webcast of the event on the Investor Relations page of the
Jeuveau™ (prabotulinumtoxinA-xvfs) is a proprietary 900 kDa purified botulinum toxin type A formulation indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adults. Jeuveau™ is produced under strict quality and safety standards in a state-of-the art facility, specifically built to manufacture Jeuveau™. The safety and efficacy of Jeuveau™ has been evaluated in clinical studies with over 2,100 patients enrolled.
FDA approval of Jeuveau™ was supported by clinical data from two U.S. Phase III randomized, multi-center, double-blind, placebo-controlled clinical trials both of which met the primary endpoint and demonstrated efficacy compared with placebo in the reduction of the severity of glabellar lines, defined as a 2-point composite improvement agreed upon by physician and patient, at Day 30. 67.5% of subjects in study one (EV-001) and 70.4% of subjects in study two (EV-002) met the primary endpoint, compared to 1.2% and 1.3% of patients in each placebo arm respectively.
IMPORTANT SAFETY INFORMATION FOR JEUVEAU™ (prabotulinumtoxinA-xvfs)
JEUVEAU may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of JEUVEAU:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
Do not use JEUVEAU if you: are allergic to any of the ingredients in JEUVEAU (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®/BOTOX® Cosmetic), abobotulinumtoxinA (DYSPORT®), or incobotulinumtoxinA (XEOMIN®); have a skin infection at the planned injection site; or are a child.
Jeuveau dosing units are not the same as, or comparable to, any other botulinum.
Tell your healthcare provider about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, Myasthenia gravis, or Lambert-
Tell your healthcare provider about all your medical conditions, including: any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed (it is not known if JEUVEAU can harm your unborn baby or passes into breast milk).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using JEUVEAU with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received JEUVEAU in the past.
Especially tell your healthcare provider if you: have received any other botulinum toxin product in the past and the last 4 months. and exactly which product you received (such as Botox, Botox Cosmetic, Myobloc, Dysport, or Xeomin).
JEUVEAU may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of treatment with JEUVEAU. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
JEUVEAU can cause other serious side effects including: allergic reactions (such as itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, reduced blinking, and corneal problems). Tell your healthcare provider or get medical emergency help right away if you experience a serious side effect.
The most common side effects include: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count in your blood.
JEUVEAU is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines). The risk information provided here is not complete. For more information about JEUVEAU, the full Prescribing Information including BOXED WARNING, and Medication Guide, visit www.evolus.com or talk to your healthcare provider.
To report side effects associated with use of JEUVEAU, please call 1-877-386-5871. You are encouraged to report negative side effects of prescription drugs to the
About Evolus, Inc.
Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. In 2019, the U.S. Food and Drug Administration approved Jeuveau™ (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Jeuveau™ is powered by Evolus' unique technology platform and is designed to transform the aesthetic market by eliminating the friction points existing for customers today. Visit us at: www.evolus.com.
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “planned,” “expect,” “believes,” “strategy,” “opportunity,” “anticipates,” “outlook,” “designed,” and similar words. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Evolus’ periodic filings with the Securities and Exchange Commission, including factors described in the section entitled ”Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2017 and its Quarterly Report on Form 10-Q for the Quarter ended September 30, 2018, as filed with the Securities and Exchange Commission on March 29, 2018 and November 5, 2018, respectively, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Evolus undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.
Use of Non-GAAP Financial Measures
For a reconciliation of non-GAAP Operating Expense to total operating expenses, the most directly comparable GAAP financial measure, please see “Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense” in the financial schedules below.
Jeuveau™ is a trademark of
Hi-Pure™ is a trademark of
Botox®, Botox® Cosmetic, Myobloc®, Dysport®, and Xeomin® are registered trademarks of their respective owners.
Vice President, Finance, Investor Relations & Treasury
|Statements of Operations and Comprehensive Loss|
|(in thousands, except earnings and loss per share data)|
|Three Months Ended
|Research and development||$||1,184||$||1,208||$||6,487||$||6,689|
|General and administrative||12,222||1,650||29,146||4,819|
|Revaluation of contingent royalty obligation||(900||)||—||10,500||—|
|Depreciation and amortization||2||—||9||218|
|Total operating expenses||12,508||2,858||46,142||11,726|
|Loss from operations||(12,508||)||(2,858||)||(46,142||)||(11,726||)|
|Other income (expense):|
|Loss before taxes||(12,418||)||(2,859||)||(46,802||)||(11,731||)|
|Provision (benefit) for income taxes||24||(7,307||)||65||(7,251||)|
|Net (loss) income and comprehensive (loss) income||$||(12,442||)||$||4,448||$||(46,867||)||$||(4,480||)|
|Net (loss) earnings per share, basic||$||(0.46||)||$||0.25||$||(1.92||)||$||(0.27||)|
|Weighted-average shares outstanding used to compute basic net loss per share||27,325||16,527||24,402||16,527|
|Net (loss) earnings per share, diluted||$||(0.46||)||$||0.24||$||(1.92||)||$||(0.27||)|
|Weighted-average shares outstanding used to compute diluted net (loss) earnings per share||27,325||18,593||24,402||16,527|
|Summary of Balance Sheet Data|
|Balance Sheet Data:|
|Total current liabilities||5,276||212,748|
|Total stockholders’ equity (deficit)||$||84,384||$||(75,543||)|
|Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense|
|Three Months Ended
|GAAP operating expense||$||12,508||$||2,858||$||46,142||$||11,726|
|Revaluation of contingent royalty obligation payable||(900||)||—||10,500||—|
|Non-GAAP operating expense||$||11,548||$||2,744||$||28,671||$||11,140|