BOCA RATON, Fla.- - (BUSINESS WIRE)- - TherapeuticsMD, Inc. (NYSE MKT:TXMD), an inventive ladies' social insurance organization, today declared its second from last quarter budgetary results for the quarter finished September 30, 2016.
Second from last Quarter and Recent Developments
Declared acknowledgment of a New Drug Application (NDA) by the U.S. Sustenance and Drug Administration (FDA) for TX-004HR (restrictively affirmed exchange name Yuvvexy™), the organization's investigational utensil free estradiol vaginal softgel case for the treatment of direct to-extreme vaginal agony amid sex (dyspareunia), an indication of vulvar and vaginal decay (VVA) because of menopause. The NDA is bolstered by the entire TX-004HR clinical program, including positive stage 3 comes about with each of the three measurements of TX-004HR (4 mcg, 10 mcg and 25 mcg) that were assessed in the Rejoice Trial. The FDA's Prescription Drug User Fee Act (PDUFA) target activity date for the NDA is May 7, 2017.
Envision topline brings about the final quarter of 2016 for the progressing Replenish Trial, a stage 3 clinical trial of the organization's TX-001HR item applicant, which, if endorsed, would be the first and final FDA-affirmed bio-indistinguishable blend of estradiol and progesterone for the treatment of direct to-serious vasomotor manifestations because of menopause.
Net income from the organization's remedy pre-birth vitamin business expanded 7 percent to around $5.5 million for the second from last quarter of 2016, contrasted and roughly $5.2 million for the second from last quarter of 2015.
Net misfortune was roughly $25.0 million for the second from last quarter of 2016, contrasted and around $19.5 million for the second from last quarter of 2015.
Finished the quarter with roughly $147.5 million in real money and no obligation.
Upheld nine presentations at yearly gatherings of the International Menopause Society (IMS) and North American Menopause Society (NAMS), including writes about the positive results from the TX-004HR clinical advancement program and new information that further distinguish ladies' view of VVA and accessible treatment alternatives.
Developed the organization's protected innovation portfolio to a present aggregate of 149 patent filings, including 82 worldwide filings, with 17 issued U.S. licenses.
Fortified associations with therapeutic, drug store, patient and industry associations universally.
"We are gaining brilliant ground this year propelling our pipeline and upgrading our business abilities concentrated on ladies' wellbeing. Amid the quarter, we effectively finished the accommodation of our NDA for TX-004HR as a novel treatment for direct to serious dyspareunia, a manifestation of VVA because of menopause, and we kept progressing pre-commercialization exercises for this imperative item," said TherapeuticsMD CEO Robert G. Finizio. "We now willingly anticipate the topline information from our Replenish Trial for TX-001HR in the final quarter of 2016, our second novel hormone treatment program, which, if endorsed, would be the first and final FDA-affirmed bio-indistinguishable blend of estradiol and progesterone for the treatment of direct to-serious vasomotor side effects because of menopause."
Outline of Third Quarter 2016 Financial Results
Net income from the organization's remedy pre-birth vitamins expanded 7 percent to roughly $5.5 million for the second from last quarter of 2016 from around $5.2 million for the earlier year's quarter.
Cost of merchandise sold was roughly $1.2 million for the second from last quarter of both 2016 and 2015.
Add up to working costs for the second from last quarter of 2016 included innovative work (R&D) costs and deals, general and regulatory costs (SG&A). Research and development costs amid the second from last quarter of 2016 were around $14.7 million contrasted with roughly $16.4 million amid the earlier year's quarter, mirroring a decrease in the organization's clinical trial costs. SG&A costs for the second from last quarter of 2016 were around $14.7 million contrasted and roughly $7.1 million for the earlier year's quarter. Higher SG&A costs amid the second from last quarter of 2016 were principally because of an expansion in the organization's business, advertising and administrative work force to bolster future commercialization of the organization's pipeline items.
Net misfortune for the second from last quarter of 2016 was around $25.0 million, or $0.13 per essential and weakened share, contrasted and roughly $19.5 million, or $0.11 per fundamental and weakened share, for the second from last quarter of 2015.
At September 30, 2016, money available was around $147.5 million, contrasted and roughly $64.7 million at December 31, 2015.
Telephone call Today
As beforehand declared, TherapeuticsMD will have a phone call today to talk about these monetary results and give a business overhaul. Points of interest for the call are:
Date:
Thursday, November 3, 2016
Time:
4:30 p.m. EDT
Phone Access (US):
866-665-9531
Phone Access (International):
724-987-6977
Get to Code for All Callers:
99198056
Also, a live webcast can be gotten to on the organization's site, www.therapeuticsmd.com, in the "Financial specialists and Media" area. A computerized recording of the phone call will be accessible for replay starting two hours after the call's fruition and for no less than 30 days with the dial-in 855-859-2056 or global 404-537-3406 and Conference ID: 99198056.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an imaginative medicinal services organization concentrated on creating and commercializing items solely for ladies. With its SYMBODA™ innovation, TherapeuticsMD is creating propelled hormone treatment pharmaceutical items to empower conveyance of bio-indistinguishable hormones through an assortment of measurements structures and organization courses. The organization's clinical improvement pipeline incorporates two stage 3 items. The organization likewise produces and appropriates marked and non specific remedy pre-birth vitamins and in addition over-the-counter vitamins under the vitaMedMD® and BocaGreenMD® brands. More data is accessible at the accompanying sites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.
Forward-Looking Statements
This official statement by TherapeuticsMD, Inc. may contain forward-looking proclamations. Forward-looking articulations may incorporate, however are not constrained to, explanations identifying with TherapeuticsMD's goals, arrangements and techniques and additionally proclamations, other than verifiable certainties, that address exercises, occasions or advancements that the organization means, expects, extends, accepts or envisions will or may happen later on. These announcements are regularly portrayed by phrasing, for example, "trusts," "trusts," "may," "envisions," "ought to," "means," "arrangements," "will," "expects," "gauges," "ventures," "situated," "methodology" and comparative expressions and depend on suspicions and appraisals made in light of administration's understanding and impression of recorded patterns, current conditions, expected future advancements and different components accepted to be suitable. Forward-looking proclamations in this public statement are made as of the date of this official statement, and the organization embraces no obligation to redesign or modify any such articulations, whether as an aftereffect of new data, future occasions or something else. Forward-looking proclamations are not certifications of future execution and are liable to dangers and vulnerabilities, a hefty portion of which are outside of the organization's control. Vital variables that could bring about genuine results, advancements and business choices to contrast really from forward-looking proclamations are portrayed in the segments titled "Hazard Factors" in the organization's filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and also covers Form 8-K, and incorporate the accompanying: the organization's capacity to keep up or increment offers of its items; the organization's capacity to create and popularize its hormone treatment sedate hopefuls and acquire extra financing vital therefor; whether the FDA will support the organization's new medication application for its TX-004HR item competitor and whether any such endorsement will happen by the PDUFA date; the length, cost and questionable consequences of the organization's clinical trials; the capability of unfavorable symptoms or other dangers that could block the endorsement of the organization's hormone treatment tranquilize applicants; the organization's dependence on outsiders to direct its clinical trials, innovative work and assembling; the accessibility of repayment from government powers and health care coverage organizations for the organization's items; the effect of item obligation claims; the impact of broad and expensive government control; the instability of the exchanging cost of the organization's normal stock and the convergence of force in its stock possession. PDF duplicates of the organization's chronicled official statements and money related tables can be seen and downloaded at its site: www.therapeuticsmd.com/pressreleases.aspx.
Second from last Quarter and Recent Developments
Declared acknowledgment of a New Drug Application (NDA) by the U.S. Sustenance and Drug Administration (FDA) for TX-004HR (restrictively affirmed exchange name Yuvvexy™), the organization's investigational utensil free estradiol vaginal softgel case for the treatment of direct to-extreme vaginal agony amid sex (dyspareunia), an indication of vulvar and vaginal decay (VVA) because of menopause. The NDA is bolstered by the entire TX-004HR clinical program, including positive stage 3 comes about with each of the three measurements of TX-004HR (4 mcg, 10 mcg and 25 mcg) that were assessed in the Rejoice Trial. The FDA's Prescription Drug User Fee Act (PDUFA) target activity date for the NDA is May 7, 2017.
Envision topline brings about the final quarter of 2016 for the progressing Replenish Trial, a stage 3 clinical trial of the organization's TX-001HR item applicant, which, if endorsed, would be the first and final FDA-affirmed bio-indistinguishable blend of estradiol and progesterone for the treatment of direct to-serious vasomotor manifestations because of menopause.
Net income from the organization's remedy pre-birth vitamin business expanded 7 percent to around $5.5 million for the second from last quarter of 2016, contrasted and roughly $5.2 million for the second from last quarter of 2015.
Net misfortune was roughly $25.0 million for the second from last quarter of 2016, contrasted and around $19.5 million for the second from last quarter of 2015.
Finished the quarter with roughly $147.5 million in real money and no obligation.
Upheld nine presentations at yearly gatherings of the International Menopause Society (IMS) and North American Menopause Society (NAMS), including writes about the positive results from the TX-004HR clinical advancement program and new information that further distinguish ladies' view of VVA and accessible treatment alternatives.
Developed the organization's protected innovation portfolio to a present aggregate of 149 patent filings, including 82 worldwide filings, with 17 issued U.S. licenses.
Fortified associations with therapeutic, drug store, patient and industry associations universally.
"We are gaining brilliant ground this year propelling our pipeline and upgrading our business abilities concentrated on ladies' wellbeing. Amid the quarter, we effectively finished the accommodation of our NDA for TX-004HR as a novel treatment for direct to serious dyspareunia, a manifestation of VVA because of menopause, and we kept progressing pre-commercialization exercises for this imperative item," said TherapeuticsMD CEO Robert G. Finizio. "We now willingly anticipate the topline information from our Replenish Trial for TX-001HR in the final quarter of 2016, our second novel hormone treatment program, which, if endorsed, would be the first and final FDA-affirmed bio-indistinguishable blend of estradiol and progesterone for the treatment of direct to-serious vasomotor side effects because of menopause."
Outline of Third Quarter 2016 Financial Results
Net income from the organization's remedy pre-birth vitamins expanded 7 percent to roughly $5.5 million for the second from last quarter of 2016 from around $5.2 million for the earlier year's quarter.
Cost of merchandise sold was roughly $1.2 million for the second from last quarter of both 2016 and 2015.
Add up to working costs for the second from last quarter of 2016 included innovative work (R&D) costs and deals, general and regulatory costs (SG&A). Research and development costs amid the second from last quarter of 2016 were around $14.7 million contrasted with roughly $16.4 million amid the earlier year's quarter, mirroring a decrease in the organization's clinical trial costs. SG&A costs for the second from last quarter of 2016 were around $14.7 million contrasted and roughly $7.1 million for the earlier year's quarter. Higher SG&A costs amid the second from last quarter of 2016 were principally because of an expansion in the organization's business, advertising and administrative work force to bolster future commercialization of the organization's pipeline items.
Net misfortune for the second from last quarter of 2016 was around $25.0 million, or $0.13 per essential and weakened share, contrasted and roughly $19.5 million, or $0.11 per fundamental and weakened share, for the second from last quarter of 2015.
At September 30, 2016, money available was around $147.5 million, contrasted and roughly $64.7 million at December 31, 2015.
Telephone call Today
As beforehand declared, TherapeuticsMD will have a phone call today to talk about these monetary results and give a business overhaul. Points of interest for the call are:
Date:
Thursday, November 3, 2016
Time:
4:30 p.m. EDT
Phone Access (US):
866-665-9531
Phone Access (International):
724-987-6977
Get to Code for All Callers:
99198056
Also, a live webcast can be gotten to on the organization's site, www.therapeuticsmd.com, in the "Financial specialists and Media" area. A computerized recording of the phone call will be accessible for replay starting two hours after the call's fruition and for no less than 30 days with the dial-in 855-859-2056 or global 404-537-3406 and Conference ID: 99198056.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an imaginative medicinal services organization concentrated on creating and commercializing items solely for ladies. With its SYMBODA™ innovation, TherapeuticsMD is creating propelled hormone treatment pharmaceutical items to empower conveyance of bio-indistinguishable hormones through an assortment of measurements structures and organization courses. The organization's clinical improvement pipeline incorporates two stage 3 items. The organization likewise produces and appropriates marked and non specific remedy pre-birth vitamins and in addition over-the-counter vitamins under the vitaMedMD® and BocaGreenMD® brands. More data is accessible at the accompanying sites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.
Forward-Looking Statements
This official statement by TherapeuticsMD, Inc. may contain forward-looking proclamations. Forward-looking articulations may incorporate, however are not constrained to, explanations identifying with TherapeuticsMD's goals, arrangements and techniques and additionally proclamations, other than verifiable certainties, that address exercises, occasions or advancements that the organization means, expects, extends, accepts or envisions will or may happen later on. These announcements are regularly portrayed by phrasing, for example, "trusts," "trusts," "may," "envisions," "ought to," "means," "arrangements," "will," "expects," "gauges," "ventures," "situated," "methodology" and comparative expressions and depend on suspicions and appraisals made in light of administration's understanding and impression of recorded patterns, current conditions, expected future advancements and different components accepted to be suitable. Forward-looking proclamations in this public statement are made as of the date of this official statement, and the organization embraces no obligation to redesign or modify any such articulations, whether as an aftereffect of new data, future occasions or something else. Forward-looking proclamations are not certifications of future execution and are liable to dangers and vulnerabilities, a hefty portion of which are outside of the organization's control. Vital variables that could bring about genuine results, advancements and business choices to contrast really from forward-looking proclamations are portrayed in the segments titled "Hazard Factors" in the organization's filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and also covers Form 8-K, and incorporate the accompanying: the organization's capacity to keep up or increment offers of its items; the organization's capacity to create and popularize its hormone treatment sedate hopefuls and acquire extra financing vital therefor; whether the FDA will support the organization's new medication application for its TX-004HR item competitor and whether any such endorsement will happen by the PDUFA date; the length, cost and questionable consequences of the organization's clinical trials; the capability of unfavorable symptoms or other dangers that could block the endorsement of the organization's hormone treatment tranquilize applicants; the organization's dependence on outsiders to direct its clinical trials, innovative work and assembling; the accessibility of repayment from government powers and health care coverage organizations for the organization's items; the effect of item obligation claims; the impact of broad and expensive government control; the instability of the exchanging cost of the organization's normal stock and the convergence of force in its stock possession. PDF duplicates of the organization's chronicled official statements and money related tables can be seen and downloaded at its site: www.therapeuticsmd.com/pressreleases.aspx.
No comments:
Post a Comment
Note: only a member of this blog may post a comment.