Full Press Release Details
TherapeuticsMD, Inc. 8-K
Announces Fourth Quarter and Full-Year 2018 Financial Results
Launch of IMVEXXY , Strong Positive
Continue for Prescriptions and Patient Refills-
Commercial Launch on Track for the Second Quarter of 2019-
Commercial Launch planned as Early as the Third Quarter of 2019-
Call Scheduled for 4:30 p.m. ET Today-
RATON, Fla. - February 21, 2019 - TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women's
healthcare company, today announced its commercial and corporate update for the fourth quarter and full-year ended December 31,
2018, we completed our most successful year to date and transformed into a leading women's
healthcare company," said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. "As we begin 2019,
we are focused on executing the next phases of our commercialization strategy. IMVEXXY continues to deliver strong growth in prescriptions
and in patient refill activity. Its success has laid the foundation for the upcoming launches of BIJUVA in the second quarter
of this year and ANNOVERA as early as the third quarter of this year. We are enthusiastic about expanding our BIO-IGNITESM
program with our compounding pharmacy partners that represent a large and important channel for physicians and patients
in hormone therapy."
Launch Continues to Highlight Successful Launch Execution
company commenced the U.S. commercial launch of IMVEXXY (estradiol vaginal inserts) 10-mcg dose in August 2018 and the 4-mcg dose
in September 2018 with the support of 150 sales representatives. IMVEXXY is currently available in major U.S. pharmacy chains
and through BIO-IGNITE compounding pharmacy partners.
| o | Approximately 47,500 prescriptions of IMVEXXY were dispensed to approximately 22,200 patients during the fourth quarter of 2018. The 3-fold increase in prescription volume for the fourth quarter of 2018 as compared to our launch during the third quarter of 2018. | |
| o | From launch through December 31, 2018, approximately 62,400 prescriptions were dispensed to approximately 25,500 patients and approximately 7,300 prescribers had a filled prescription for the product. | |
| o | Strong refill rates suggest women are having a positive experience with IMVEXXY. Patients who began treatment in August 2018 have obtained an average of 4.9 refills through January 2019, out of a possible 6 refills. | |
| o | Through December 31, 2018, the company achieved unrestricted coverage with six of the top ten commercial payers, with three of them adjudicating on January 1, 2019. This includes two commercial payers that were added in the fourth quarter of 2018, which was a large contributor to the 4-fold increase in net revenue growth for IMVEXXY for the fourth quarter of 2018 as compared to our launch during the third quarter of 2018. |
| o | After year end, the company came to agreement for commercial coverage of IMVEXXY with United Healthcare, the third largest commercial payer in the U.S, to begin adjudication on March 1, 2019. Additionally, the company secured coverage from United Healthcare and Kaiser (limited to only the maintenance pack) for their Medicare Part D plans. | |
| o | IMVEXXY prescription growth continues into 2019 as highlighted by a record month in January 2019. | |
| o | IMVEXXY average weekly prescription volume for the first two weeks of February 2019 increased to approximately 5,800 as compared to average weekly volume of approximately 5,300 in January 2019. |
Expected Events in 2019
2019 - Speaker medical education programs throughout the United States highlighting the clinical and physical attributes of IMVEXXY
2019 through 3Q 2019 - Expand IMVEXXY Part D coverage
2019 - Expand sales force by 25% to 200 sales representatives to increase reach of IMVEXXY and launch BIJUVA
2019 - Begin direct-to-consumer marketing for IMVEXXY
2019 - U.S. commercial launch of BIJUVA (estradiol and progesterone) capsules and draw second $75 million debt tranche with
MidCap Financial Trust
(targeting 3Q) 2019 - U.S. commercial launch of ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)
2019 - Debt funding for ANNOVERA
2019 - Company to hold Analyst Day
4Q 2019 - BIJUVA 6-month "new to market" payer block expected to end
year 2019 - Oral presentations and posters related to clinical benefits of IMVEXXY, BIJUVA and ANNOVERA at medical meetings
2019 - Continue to expand BIO-IGNITE with a fuller expansion towards the end of 2019 when the six-month payer block for BIJUVA
of Fourth Quarter and Full Year 2018 Financial Results
the year ended December 31, 2018, net revenues were approximately $16.1 million compared with approximately $16.8 million for
the prior year. Net revenues for the fourth quarter of 2018 were approximately $5.1 million compared with net revenues of approximately
$4.1 million for the prior year's quarter. Net revenues from the company's prescription prenatal vitamin business
were approximately $4.2 million for the fourth quarter of 2018, compared with approximately $4.1 million for the fourth quarter
of 2017. Net revenues for IMVEXXY for the fourth quarter of 2018 were approximately $0.9 million and were greatly affected by
our co-pay assistance program introduced to launch IMVEXXY, which is a maximum $35 out-of-pocket copay assistance program that
allows eligible patients to access the product for a reasonable cost regardless of the insurance coverage. The decrease in full-year
2018 net revenues related to lower prenatal vitamins revenues of approximately $1.6 million, primarily due to a lower number of
units sold and higher utilization of coupons offered to customers in 2018 as compared to the prior year, partially offset by approximately
$1.1 million in net revenues for IMVEXXY. Net revenues for IMVEXXY were greatly affected by our co-pay assistance program. The
company expects the net revenues for IMVEXXY to improve as commercial payer coverage for IMVEXXY increases and insurance plans
complete the process needed to adjudicate IMVEXXY prescriptions at pharmacies.
and development (R&D) expenses for the full-year 2018 decreased to approximately $27.3 million, compared with approximately
$33.9 for the prior year. R&D expenses for the fourth quarter of 2018 were approximately $6.8 million compared with approximately
$11.0 million for the prior year's quarter. The decrease in full-year 2018 R&D expenses was primarily as a result of
the completion of the REPLENISH Trial for BIJUVA and FDA approval of IMVEXXY and BIJUVA, partially offset by scale-up and manufacturing
activities for BIJUVA before FDA approval as well as increased pre-clinical work to support our product pipeline.
general and administrative (SG&A) expenses for the full-year 2018 increased to approximately $116.0 million, compared with
approximately $57.7 million for the prior year. SG&A expenses for the fourth quarter of 2018 were approximately $35.4 million
compared with approximately $14.2 million for the prior year's quarter. The increase in full-year 2018 sales and marketing
expenses was primarily a result of increased expenses associated with sales and marketing efforts to support launch and commercialization
of IMVEXXY and BIJUVA, including costs related to outsourced sales personnel and their related expenses, physician education and
product samples, advertising and travel expenses related to product commercialization. The company expects sales and marketing
expenses to continue to increase as it continues the launch of BIJUVA, prepares for the launch of ANNOVERA and continues to support
its growing business and commercialization of its products.
loss for the full-year 2018 was approximately $132.6 million, or $0.59 per basic and diluted share, compared with approximately
$76.9 million, or $0.37 per basic and diluted share, for the full-year of 2017. Net loss for the fourth quarter of 2018 was approximately
$39.4 million, or $0.17 per basic and diluted share, compared with approximately $21.4 million, or $0.10 per basic and diluted
share, for the fourth quarter of 2017.
of December 31, 2018, the company's cash on hand totaled approximately $161.6 million, compared with approximately $127.1
million at December 31, 2017. Total outstanding debt, net of issuance costs, was approximately $73.4 million as of December 31,
Call and Webcast Details
will host a conference call and audio webcast today, at 4:30 p.m. ET to discuss these financial results and provide a business
| Date: | Thursday, February 21, 2019 |
| Time: | 4:30 p.m. ET |
| Telephone Access (US): | 866-665-9531 |
| Telephone Access (International): | 724-987-6977 |
| Access Code for All Callers: | 3494187 |
live webcast and audio archive for the event may be accessed on the home page or from the "Investors & Media"
section of the TherapeuticsMD website at www.therapeuticsmd.com. Please connect to the website prior to the start of the presentation
to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will
be archived on the website for at least 30 days. In addition, a digital recording of the conference call will be available for
replay beginning two hours after the call's completion and for at least 30 days with the dial-in 855-859-2056 or international
404-537-3406 and Conference ID: 3494187.
see the Full Prescribing Information, including indication and Boxed WARNING, for each TherapeuticsMD product as follows:
| IMVEXXY at https://imvexxy.com/pi.pdf | ||
| BIJUVA at https://www.bijuva.com/pi.pdf | ||
| ANNOVERA at www.annovera.com/pi.pdf |
About TherapeuticsMD,
Inc. is an innovative healthcare company focused on developing and commercializing novel products exclusively for women.
Our products are designed to address the unique changes and challenges women experience
through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management.
The company is committed to advancing the health of women and championing awareness of their
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press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include,
but are not limited to, statements relating to TherapeuticsMD's objectives, plans and strategies as well as statements,
other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes
or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes,"
"hopes," "may," "anticipates," "should," "intends," "plans,"
"will," "expects," "estimates," "projects," "positioned," "strategy"
and similar expressions and are based on assumptions and assessments made in light of management's experience and perception
of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking
statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or
revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are
not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company's
control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking
statements are described in the sections titled "Risk Factors" in the company's filings with the Securities
and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports
on Form 8-K, and include the following: the company's ability to maintain or increase sales of its products; the company's
ability to develop and commercialize IMVEXXY , ANNOVERATM, BIJUVATM and its hormone therapy