BOCA RATON, Fla.--(EON: Enhanced Online News)--TherapeuticsMD, Inc. (NYSE MKT:TXMD), a women’s healthcare company, today announced financial results for the three- and nine-month periods ended September 30, 2013.
Third Quarter 2013 Highlights:
- Net revenue increased to $2.3 million compared with $1.0 million for the third quarter of 2012;
- Net loss increased to $7.7 million as compared with a net loss of $4.3 million for the third quarter of 2012;
- Released results of a 48-patient, 14-day phase 1 clinical study, which indicated that treatment with TX 12-004-HR estradiol VagiCap™ at the 10μg dose improved objective measures of Vulvar and Vaginal Atrophy;
- Received the first-place prize at the North American Menopause Society (NAMS) 2013 Annual Meeting for our poster detailing findings on the first investigational combination 17β-estradiol and progesterone capsule (TX 12-001-HR E+P) that may have overcome the well-recognized difficulties of achieving good bioavailability with oral administration of these hormones in combination;
- Initiated the REPLENISH Trial, a phase 3 clinical trial designed to measure the safety and effectiveness of TX 12-001-HR E+P, in treating the symptoms of menopause;
- Raised approximately $33 million in gross proceeds through an underwritten offering of 13,750,000 shares of common stock; and,
- Appointed Sebastian Mirkin, M.D., a prominent women’s health product development executive with extensive experience in the pharmaceutical industry and clinical research, as Chief Medical Officer, effective November 25, 2013.
Robert G. Finizio, Co-Founder and Chief Executive Officer, stated, “We are pleased with the progress of our clinical initiatives for our three hormone-candidate products and look forward to making continued headway to support our goal of bringing innovative women’s healthcare products to market. The recognition that we received by NAMS for our innovative poster, underscoring the potential benefits of our combination product, the significant hire of Dr. Sebastian Mirkin and a solid balance sheet creates strong, positive momentum for TXMD.”
Third Quarter Results
Net revenue for the third quarter of 2013 totaled $2.3 million compared with net revenue of $1.0 million for the year ago quarter. The increase of approximately $1.3 million, or 121%, was directly attributable to an increase in the number of physicians writing prescriptions for our prenatal products, the increased productivity of our sales force, an increase in the average net sales price of our product, and new prescription products introduced in March, April, May and November 2012. Cost of goods sold increased by $342 thousand, or 111%, for the three months ended September 30, 2013 compared with the prior year quarter. Research and development expenses increased to $4.1 million for the third quarter of 2013 compared with $1.7 million for the third quarter of 2012, due to costs incurred in the development of our new hormone replacement therapy and prescription prenatal products. Sales, general and administrative expenses increased to $4.8 million for the third quarter of 2013 compared with $2.9 million for the third quarter of 2012. As a result, our operating loss was $7.2 million for the third quarter of 2013 compared with $3.9 million for the third quarter of 2012.
Other non-operating expenses increased by approximately $93,000 for the third quarter of 2013 compared with the comparable quarter in 2012. This increase was primarily a result of non-cash financing costs incurred during the current period totaling approximately $448,000, partially offset by a decrease in interest expense of approximately $134,000 and loss on extinguishment of debt of approximately $197,000.
As a result, net loss for the third quarter of 2013 was $7.7 million, or $0.06 per basic and diluted share, compared with a net loss of $4.3 million, or $0.04 per basic and diluted share, for the third quarter of 2012.
Nine Months Results
Net revenue for the nine months ended September 30, 2013 totaled $5.9 million compared with net revenue of approximately $2.6 million for the year ago period. The increase of approximately $3.3 million, or 129%, was directly attributable to an increase in the number of physicians writing prescriptions for our prenatal products, the increased productivity of our sales force, an increase in the average net sales price of our product, and new prescription products introduced in March, April, May and November 2012. Cost of goods sold increased by $477 thousand, or 47%, for the nine months ended September 30, 2013 compared with the prior year period. Research and development expenses increased to $7.7 million for the nine months ended September 30, 2013 compared with $3.1 million for the comparable period in 2012, because of costs incurred in the development of our new hormone replacement therapy and prescription prenatal products. Sales, general and administrative expenses increased to $14.5 million for the nine months ended September 30, 2013 compared with $9.1 million for the prior year period. As a result, our operating loss was $17.8 million for the nine months ended September 30, 2013 compared with $10.8 million for the comparable period in 2012.
Other non-operating expenses decreased by $16.4 million for the nine months ended September 30, 2013 compared with the comparable period in 2012. This decrease resulted primarily from a loss on extinguishment of debt, the beneficial conversion of debt and interest expense incurred during 2012, partially offset by an increase in amortization of financing costs of $1.1 million.
As a result, net loss for the nine months ended September 30, 2013 was $20.0 million, or $0.16 per basic and diluted share, compared with a net loss of $29.4 million, or $0.33 per basic and diluted share, for the comparable period in 2012.
Cash and cash equivalents increased to $59.6 million at September 30, 2013.
As previously announced, Robert G. Finizio, Co-Founder and Chief Executive Officer, and Dan Cartwright, Chief Financial Officer, will host a conference call today to review the results as follows:
|Date||November 4, 2013|
|Time||4:30 p.m. (Eastern Standard Time)|
|Telephone access||800-619-2686 (U.S. and Canada)|
www.therapeuticsmd.com, under the Investor tab
An audio replay will be available on-demand shortly after the completion of the call until November 18, 2013 at 11:59 pm EST at the aforementioned URL, or by dialing 800-633-8284 in the U.S. and Canada, or 402-977-9140 from abroad. The access code for all callers is 21682427.
About Hormone Therapy
Hormone therapy (HT) is the administration of hormones to supplement a lack of naturally occurring hormones. HT options include natural, bioidentical, and non-bioidentical (conjugated) hormones. HT is projected to be the largest growth segment in the overall women’s health market. The potential market for pharmacy-compounded, bioidentical HT products is estimated to be approximately $1.5 billion per year.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD™ brands. We are currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. We are also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.
vitaMedMD® and TherapeuticsMD® are registered trademarks of TherapeuticsMD, Inc. and BocaGreenMD™ is a trademark of TherapeuticsMD, Inc.
Except for the historical information contained herein, the matters set forth in this press release, including statements relating to future events or performance, including statements regarding the company’s performance; the results of the phase 1 clinical study of TX 12-004-HR; the possibility that TX 12-001-HR may have overcome the well-recognized difficulties of achieving good bioavailability with oral administration in combination; the REPLENISH trial; the company’s plans for the clinical initiatives of its three hormone-candidate products; the company’s goal of bringing innovative women’s healthcare products to market; the impact of the recognition the company received at the NAMS annual meeting; the impact of the appointment of Dr. Mirkin; the impact of the increase in sales territories, sales people, and new prescription products; the impact of development of the company’s new hormone replacement therapy and prescription prenatal products; projected growth and the size of the potential market for pharmacy-compounded, bioidentical HT products; the company’s current product pipeline and hormone technology that the company is evaluating are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies and the results thereof; challenges and costs inherent in product marketing; the risks and uncertainties associated with economic and market conditions; risks and uncertainties associated with the Company’s business and finances in general; and other risks detailed in the Company’s filings with the U.S. Securities and Exchange Commission including its annual report on Form 10-K filed on March 12, 2013, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
|THERAPEUTICSMD, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30, 2013||December 31, 2012|
|Cash||$ 59,572,347||$ 1,553,474|
|Accounts receivable, net of allowances|
|of $90,403 and $42,048, respectively||1,793,719||606,641|
|Other current assets||3,419,704||751,938|
|Total current assets||65,933,356||4,527,263|
|Fixed assets, net||47,392||65,673|
|Total other assets||2,496,584||1,225,159|
|Total assets||$ 68,477,332||$ 5,818,095|
|LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)|
|Accounts payable||$ 2,471,951||$ 1,641,366|
|Other current liabilities||2,066,116||725,870|
|Total current liabilities||6,390,339||3,511,988|
|Notes payable, net of debt discount of $0 and $1,102,680, respectively||-||3,589,167|
|Total long-term liabilities||-||3,739,235|
|Commitments and Contingencies|
|Stockholders' Equity (Deficit):|
|Preferred stock - par value $0.001; 10,000,000 shares authorized;|
|no shares issued and outstanding||-||-|
|Common stock - par value $0.001; 250,000,000 shares authorized;|
|144,962,706 and 99,784,982 issued and outstanding, respectively||144,963||99,785|
|Additional paid-in capital||134,095,517||50,580,400|
|Total stockholder' equity (deficit)||62,086,993||(1,433,128)|
|Total liabilities and stockholders' equity (deficit)||$ 68,477,332||$ 5,818,095|
|THERAPEUTICSMD, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Cost of goods sold||648,403||306,843||1,492,355||1,015,337|
|Sales, general, and administration||4,752,062||2,923,242||14,455,839||9,139,894|
|Research and development||4,098,903||1,702,120||7,710,546||3,131,306|
|Depreciation and amortization||32,356||14,839||50,949||43,952|
|Total operating expense||8,883,321||4,640,201||22,217,334||12,315,152|
|Other income (expense):|
|Loan guaranty costs||-||(11,745||)||(2,944||)||(35,235||)|
|Beneficial conversion feature||-||-||-||(6,716,504||)|
|Loss on extinguishment of debt||-||(197,383||)||-||(10,505,247||)|
|Total other income (expense)||(436,004||)||(342,671||)||(2,243,285||)||(18,639,709||)|
|Loss before taxes||(7,673,008||)||(4,253,259||)||(20,040,174||)||(29,392,900||)|
|Provision for income taxes||-||-||-||-|
|Loss per share, basic and diluted:|
|Net loss per share, basic and diluted||$||(0.06||)||$||(0.04||)||$||(0.16||)||$||(0.33||)|
|Weighted average number of common|
|THERAPEUTICSMD, INC. AND SUBSIDIARIES|
|CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS|
|Nine Months Ended|
|CASH FLOWS FROM OPERATING ACTIVITIES|
|Adjustments to reconcile net loss to net cash flows used in|
|Amortization of intangible assets||9,764||22,711|
|Provision for doubtful accounts||48,355||33,213|
|Amortization of debt discount||1,102,680||1,159,375|
|Stock based compensation||1,926,992||1,031,685|
|Amortization of deferred financing costs||1,055,948||-|
|Stock based expense for services||804,878||233,093|
|Loan guaranty costs||2,944||35,235|
|Loss on debt extinguishment||-||10,505,247|
|Beneficial conversion feature||-||6,716,504|
|Changes in operating assets and liabilities:|
|Other current assets||(1,927,156||)||(28,925||)|
|Other current liabilities||1,340,246||(66,087||)|
|Net cash flows used in operating activities||(15,892,725||)||(8,730,667||)|
|CASH FLOWS FROM INVESTING ACTIVITIES|
|Payment of security deposit||(106,358||)||-|
|Purchase of property and equipment||(23,755||)||(68,904||)|
|Net cash flows used in investing activities||(387,746||)||(157,127||)|
|CASH FLOWS FROM FINANCING ACTIVITIES|
|Proceeds from sale of common stock, net||78,984,960||125,001|
|Proceeds from line of credit||500,000||-|
|Proceeds from exercise of options||6,231||190,999|
|Proceeds from notes and loans payable||-||8,700,000|
|Repayment of notes payable||(4,691,847||)||(50,780||)|
|Repayment of line of credit||(500,000||)||-|
|Repayment of notes payable-related party||-||(50,000||)|
|Proceeds from sale of warrants||-||400|
|Net cash flows provided by financing activities||74,299,344||8,915,620|
|Increase in cash||58,018,873||27,826|
|Cash, beginning of period||1,553,474||126,421|
|Cash, end of period||59,572,347||$||154,247|
|SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:|
|Cash paid for interest||$||212,853||$||37,087|
|Cash paid for income taxes||$||-||$||-|
|SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES:|
|Warrants issued for financing||$||1,711,956||$||2,509,537|
|Warrants issued for services||$||462,196||$||1,532,228|
|Warrants issued in exchange for debt and accrued interest||$||-||$||3,102,000|
|Shares issued in exchange for debt and accrued interest||$||-||$||1,054,658|
|Notes payable issued for accrued interest||$||-||$||15,123|