UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported):
(Exact Name of Registrant as Specified in its Charter)
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (IRS
Employer Identification No.) |
| (Address of Principal Executive Office) (Zip Code) |
Registrant’s
telephone number, including area code:
| N/A |
| (Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230-405) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 | Results of Operations and Financial Condition. |
On November 6, 2019, TherapeuticsMD, Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 2019. In addition, the Company will be using a slide presentation during its earnings conference call. A copy of the press release and slide presentation are furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
The information in Item 2.02 of this Current Report on Form 8-K (including the exhibits) is furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in Item 2.02 of this Current Report on Form 8-K (including the exhibits) shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.
The Company does not have, and expressly disclaims, any obligation to release publicly any updates or any changes in its expectations or any change in events, conditions, or circumstances on which any forward-looking statement is based.
| Item 7.01 | Regulation FD Disclosure. |
On November 6, 2019, the Company issued a press release announcing the Company’s financial results for its third quarter ended September 30, 2019. In addition, the Company will be using a slide presentation during its earnings conference call. The information included in this Item 7.01 and in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
Exhibit Index
|
Exhibit Number |
Description | |
|
Press Release from TherapeuticsMD, Inc., dated November 6, 2019, entitled TherapeuticsMD Announces Third Quarter 2019 Financial Results.
| |
| 99.2 | TherapeuticsMD, Inc. Presentation dated November 6, 2019.
| |
| 104 | Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| THERAPEUTICSMD, INC. | ||
| Date: November 6, 2019 | By: | /s/ Daniel A. Cartwright |
| Name: | Daniel A. Cartwright | |
| Title: |
Chief Financial Officer | |
Exhibit 99.1
FOR IMMEDIATE RELEASE
TherapeuticsMD Announces Third Quarter 2019 Financial Results
- 3Q19 Net Revenue (Product and License) Increased to $23.7 Million -
- 3Q19 Product Net Revenue Increased 34% to $8.2 Million Compared to 2Q19-
- The Company Reaffirms 4Q19 Financial Guidance -
- Conference Call Scheduled for 4:30 p.m. ET Today -
BOCA RATON, Fla. – November 6, 2019 – TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the third quarter ended September 30, 2019 and provided a business update.
“We are very pleased with our results for the quarter, which are in-line with our financial guidance, and reaffirm our fourth quarter 2019 financial guidance,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. “This reiterates our confidence that we will be able to access an additional $50 million in capital from our term loan facility when fourth quarter 2019 results are announced. Additionally, we recently completed an equity raise that netted the company approximately $77 million and improved our liquidity. We believe we now have the resources and momentum to continue to fully execute our plans into 2020 and beyond.”
Third Quarter and Recent Developments
| • | IMVEXXY® (estradiol vaginal inserts) third quarter 2019 product net revenue increased by 53% to approximately $4.8 million and prescriptions dispensed and paid for by patients increased 26% to approximately 134,000 as compared to the second quarter of 2019. Strong refill rates continued with patients adhering to therapy at an average rate of four fills per year through September 2019. |
| • | IMVEXXY has market access for the majority of lives under commercial plans with approximately 68% unrestricted commercial access. IMVEXXY is now covered by eight of the ten top commercial payers of vulvar and vaginal atrophy (VVA) products. A ninth top-ten commercial payer will adjudicate beginning in January 2020. Two of the top six Medicare Part D payers of VVA products cover IMVEXXY and additional Medicare coverage decisions are expected by the end of 2019. |
| • | BIJUVA® (estradiol and progesterone) capsules third quarter 2019 product net revenue and prescriptions increased two-fold to approximately $0.5 million and approximately 15,800 prescriptions dispensed and paid for by patients during the third quarter as compared to the second quarter of 2019. |
| • | BIJUVA currently has approximately 55% unrestricted commercial access and is covered by six of the top ten commercial payers. |
| • | ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) generated third quarter product net revenue of approximately $0.4 million. The company is in the “test and learn” market introduction phase of launch for ANNOVERA, the first and only long-lasting, patient-controlled, procedure-free, reversible prescription contraceptive option for women. |
| • | ANNOVERA has already achieved approximately 62% unrestricted commercial access and is covered by six of the top ten commercial payers by commercial payer lives. |
| • | On October 29, 2019, the company received net proceeds of approximately $77.0 million from an underwritten public offering of its common stock to support commercialization efforts for its three FDA-approved products and to maximize ANNOVERA’s consumer-focused commercialization strategy. |
Summary of Third Quarter 2019 Financial Results
Total net revenue increased to approximately $23.7 million, for the third quarter of 2019 compared with net revenue of approximately $3.5 million for the prior year’s quarter. During the third quarter of 2019, the company recognized license revenue of approximately $15.5 million from the upfront fee, a non-refundable payment, under the company’s license agreement with Theramex, which is included in total revenue for the quarter.
Product net revenue increased to approximately $8.2 million, for the three months ended September 30, 2019 compared with approximately $3.5 million for the three months ended September 30, 2018. Product net revenue increased primarily due to increases in sales of approximately $4.5 million of IMVEXXY in the current period, partially offset by a decrease in prenatal vitamin sales of approximately $0.7 million. Product net revenue for the three months ended September 2019 also included sales of BIJUVA of approximately $0.5 million and sales of ANNOVERA of approximately $0.4 million. The revenue decrease related to our prenatal vitamins was primarily affected by a lower number of units sold as compared to the prior year period, partially offset by increased revenue per unit. The company launched IMVEXXY in the third quarter of 2018, BIJUVA in the second quarter of 2019, and ANNOVERA in the third quarter of 2019.
The following table provides information about disaggregated revenue by product mix for the three months ended September 30, 2019 and 2018:
| Three Months Ended September 30, | ||||||||
| 2019 | 2018 | |||||||
| Prenatal vitamins | $ | 2,550,330 | $ | 3,261,459 | ||||
| IMVEXXY | 4,772,354 | 212,076 | ||||||
| BIJUVA | 490,705 | — | ||||||
| ANNOVERA | 399,952 | — | ||||||
| License revenue | 15,506,400 | — | ||||||
| Net revenue | $ | 23,719,741 | $ | 3,473,535 | ||||
Net revenue for IMVEXXY and BIJUVA has been greatly affected by the company’s co-pay assistance programs introduced to provide products at a reasonable cost regardless of insurance coverage. We expect our product revenues to improve as commercial and Medicare payer coverage increases, and plans complete the process needed to adjudicate IMVEXXY, BIJUVA and ANNOVERA prescriptions at pharmacies.
Research and development (R&D) expenses for the third quarter of 2019 decreased to approximately $4.1 million, compared with approximately $6.7 million for the prior year’s quarter. R&D costs decreased primarily as a result of transferring certain costs and activities from R&D expenses to operations as they begin to support commercial and launch efforts after the FDA approval of IMVEXXY and BIJUVA. R&D expenses include costs related to manufacturing validation as well as early development trials and employment costs of personnel involved in R&D activities.
Sales, general and administrative (SG&A) expenses increased for the third quarter of 2019 to approximately $45.1 million, compared with approximately $30.4 million for the prior year’s quarter. The increase of SG&A expenses for third quarter 2019 was primarily a result of increased expenses associated with sales and marketing efforts and personnel costs to support the launch and commercialization of IMVEXXY, BIJUVA, and ANNOVERA including outsourced sales personnel and their related expenses, physician education, 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 and ANNOVERA and continues to support its growing business and commercialization of its products.
For the third quarter of 2019, net loss decreased to approximately $32.0 million, or $0.13 per basic and diluted share, compared with approximately $35.6 million, or $0.16 per basic and diluted share, for the third quarter of 2018.
Balance Sheet
As of September 30, 2019, the company’s cash on hand totaled approximately $155.3 million, compared with approximately $161.6 million at December 31, 2018. On October 29, 2019, the company received net proceeds of approximately $77.0 million from an underwritten public offering of its common stock.
Total outstanding debt, net of issuance costs, was approximately $194.4 million as of September 30, 2019.
Financial Guidance
The company reaffirms its previously announced fourth quarter 2019 financial guidance outlined below:
| • | FDA-approved product net revenue is expected to be in a range of $11 million to $13 million; |
| • | Prescription prenatal vitamin net revenue is expected to be in a range of $1.75 million to $2.25 million; and |
| • | Total product net revenue is expected to be in a range of $12.75 million to $15.25 million. |
Conference Call and Webcast Details
TherapeuticsMD will host a conference call and audio webcast today at 4:30 p.m. ET to discuss these financial results and provide a business update.
| Date: | Wednesday, November 6, 2019 | |
| Time: | 4:30 p.m. ET | |
| Telephone Access (US): | 866-665-9531 | |
| Telephone Access (International): | 724-987-6977 | |
| Access Code for All Callers: | 7045719 |
A 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: 7045719.
Please see the Full Prescribing Information, including indication and Boxed WARNING, for each TherapeuticsMD product as follows:
| • | IMVEXXY (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf |
| • | BIJUVA (estradiol and progesterone) capsules at https://www.bijuva.com/pi.pdf |
| • | ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf |
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading 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 healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.
Forward-Looking Statements
This 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®, ANNOVERA™, BIJUVA® and its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility, including the conditions to draw additional tranches thereunder; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.
# # #
Investor Contact
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| September 30, 2019 | December 31, 2018 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 155,330,050 | $ | 161,613,077 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $691,699 and $596,602, respectively | 15,323,614 | 11,063,821 | ||||||
| Inventory | 10,532,844 | 3,267,670 | ||||||
| Other current assets | 10,578,260 | 10,834,693 | ||||||
| Total current assets | 191,764,768 | 186,779,261 | ||||||
| Fixed assets, net | 2,338,346 | 472,683 | ||||||
| Other Assets: | ||||||||
| License rights, net | 39,984,002 | 20,000,000 | ||||||
| Intangible assets, net | 4,942,151 | 4,092,679 | ||||||
| Right-of-use asset | 10,459,635 | — | ||||||
| Other assets | 473,009 | 639,301 | ||||||
| Total other assets | 55,858,797 | 24,731,980 | ||||||
| Total assets | $ | 249,961,911 | $ | 211,983,924 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 24,133,506 | $ | 22,743,841 | ||||
| Other current liabilities | 43,196,032 | 18,334,948 | ||||||
| Total current liabilities | 67,329,538 | 41,078,789 | ||||||
| Long-Term Liabilities: | ||||||||
| Long-term debt | 194,361,169 | 73,381,014 | ||||||
| Operating lease liability | 9,500,133 | — | ||||||
| Total liabilities | 271,190,840 | 114,459,803 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' Equity: | ||||||||
| Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding | — | — | ||||||
| Common stock - par value $0.001; 350,000,000 shares authorized: 241,277,076 and 240,462,439 issued and outstanding, respectively | 241,277 | 240,463 | ||||||
| Additional paid-in capital | 624,515,559 | 616,559,938 | ||||||
| Accumulated deficit | (645,985,765 | ) | (519,276,280 | ) | ||||
| Total stockholders' (deficit) equity | (21,228,929 | ) | 97,524,121 | |||||
| Total liabilities and stockholders' equity | $ | 249,961,911 | $ | 211,983,924 | ||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Product revenue, net | $ | 8,213,341 | $ | 3,473,535 | $ | 18,238,857 | $ | 11,009,937 | ||||||||
| License revenue | 15,506,400 | — | 15,506,400 | — | ||||||||||||
| Total revenue, net | 23,719,741 | 3,473,535 | 33,745,257 | 11,009,937 | ||||||||||||
| Cost of goods sold | 1,444,308 | 699,118 | 3,455,995 | 1,786,902 | ||||||||||||
| Gross profit | 22,275,433 | 2,774,417 | 30,289,262 | 9,223,035 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales, general, and administrative | 45,126,986 | 30,354,072 | 121,378,519 | 80,578,079 | ||||||||||||
| Research and development | 4,077,738 | 6,708,271 | 15,359,988 | 20,545,948 | ||||||||||||
| Depreciation and amortization | 141,959 | 73,321 | 363,956 | 198,545 | ||||||||||||
| Total operating expenses | 49,346,683 | 37,135,664 | 137,102,463 | 101,322,572 | ||||||||||||
| Operating loss | (27,071,250 | ) | (34,361,247 | ) | (106,813,201 | ) | (92,099,537 | ) | ||||||||
| Other expense | ||||||||||||||||
| Loss on extinguishment of debt | — | — | (10,057,632 | ) | — | |||||||||||
| Miscellaneous income | 703,662 | 809,022 | 1,878,980 | 1,457,817 | ||||||||||||
| Interest expense | (5,599,005 | ) | (2,053,077 | ) | (11,717,632 | ) | (2,584,459 | ) | ||||||||
| Total other expense | (4,895,343 | ) | (1,244,055 | ) | (19,896,284 | ) | (1,126,642 | ) | ||||||||
| Loss before income taxes | (31,966,593 | ) | (35,605,302 | ) | (126,709,485 | ) | (93,226,179 | ) | ||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||
| Net loss | $ | (31,966,593 | ) | $ | (35,605,302 | ) | $ | (126,709,485 | ) | $ | (93,226,179 | ) | ||||
| Loss per share, basic and diluted: | ||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.16 | ) | $ | (0.53 | ) | $ | (0.42 | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | 241,261,299 | 228,107,240 | 241,163,994 | 220,466,673 | ||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2019 | 2018 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (126,709,485 | ) | $ | (93,226,179 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation of fixed assets | 223,750 | 121,423 | ||||||
| Amortization of intangible assets | 140,206 | 77,123 | ||||||
| Write off of patent and trademark cost | 78,864 | — | ||||||
| Non-cash operating lease expense | 711,836 | — | ||||||
| Provision for doubtful accounts | 95,097 | 231,475 | ||||||
| Loss on extinguishment of debt | 10,057,632 | — | ||||||
| Share-based compensation | 7,859,357 | 6,388,635 | ||||||
| Amortization of intellectual property license fee | 15,998 | — | ||||||
| Amortization of deferred financing fees | 582,829 | 149,909 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (4,354,890 | ) | (8,705,325 | ) | ||||
| Inventory | (7,265,174 | ) | (892,863 | ) | ||||
| Other current assets | (1,128,515 | ) | 1,233,482 | |||||
| Accounts payable | 1,389,665 | 7,284,493 | ||||||
| Accrued expenses and other liabilities | 3,402,511 | 8,670,986 | ||||||
| Net cash used in operating activities | (114,900,319 | ) | (78,666,841 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Payment for intellectual property license | — | (20,000,000 | ) | |||||
| Patent costs | (1,068,542 | ) | (748,906 | ) | ||||
| Purchase of fixed assets | (2,089,413 | ) | (66,295 | ) | ||||
| Payment of security deposit | (20,420 | ) | (11,485 | ) | ||||
| Net cash used in investing activities | (3,178,375 | ) | (20,826,686 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from Financing Agreement | 200,000,000 | — | ||||||
| Proceeds from exercise of options and warrants | 108,656 | 1,236,313 | ||||||
| Proceeds from sale of common stock, net of costs | — | 89,907,797 | ||||||
| Proceeds from Credit Agreement | — | 75,000,000 | ||||||
| Payment of deferred financing fees | (6,652,270 | ) | (3,786,918 | ) | ||||
| Repayment of Credit Agreement | (81,660,719 | ) | — | |||||
| Net cash provided by financing activities | 111,795,667 | 162,357,192 | ||||||
| (Decrease) increase in cash | (6,283,027 | ) | 62,863,665 | |||||
| Cash, beginning of period | 161,613,077 | 127,135,628 | ||||||
| Cash, end of period | $ | 155,330,050 | $ | 189,999,293 | ||||
| Supplemental disclosure of cash flow information | ||||||||
| Interest paid | $ | 12,446,792 | $ | 1,759,316 | ||||
| Non-cash investing activity | ||||||||
| Amount accrued for intellectual property license | $ | 20,000,000 | $ | — | ||||
Exhibit 99.2
1 1 3Q 2019 Earnings November 6, 2019 Building a Premier Women’s Health Portfolio
2 2 Forward - Looking Statements This presentation by TherapeuticsMD , Inc . (referred to as “we” and “our”) may contain forward - looking statements . Forward - looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future . These statements are often characterized by terminology such as “believe,” “hope,” “may,” “anticipate,” “should,” “intend,” “plan,” “will,” “expect,” “estimate,” “project,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of our managerial experience and perception of historical trends, current conditions, expected future developments and other factors we believe to be appropriate . Forward - looking statements in this presentation are made as of the date of this presentation, and we undertake 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 may be outside of our 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 our filings with the Securities and Exchange Commission (SEC), including our most recent Annual Report on Form 10 - K and Quarterly Reports on Form 10 - Q, as well as our current reports on Form 8 - K, and include the following : our ability to maintain or increase sales of our products ; our ability to develop and commercialize IMVEXXY, ANNOVERA, BIJUVA and its hormone therapy drug candidates and obtain additional financing necessary therefor ; whether we will be able to comply with the covenants and conditions under our term loan facility, including the conditions to draw additional tranches there under ; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of our current or future approved products or preclude the approval of our future drug candidates ; the length, cost and uncertain results of future clinical trials ; our reliance on third parties to conduct our clinical trials, research and development and manufacturing ; the ability of our licensees to commercialize and distribute our products ; the effects of laws, regulations and enforcement ; the competitive nature of the industries in which we conduct our business ; the availability of reimbursement from government authorities and health insurance companies for our products ; the impact of product liability lawsuits ; the influence of extensive and costly government regulation ; the volatility of the trading price of our common stock ; and the concentration of power in our stock ownership . This non - promotional presentation is intended for investor audiences only .
3 3 Trend in Net Revenue Prenatal Vitamin Prenatal Vitamin Prenatal Vitamin Prenatal Vitamin Prenatal Vitamin IMVEXXY IMVEXXY IMVEXXY IMVEXXY IMVEXXY BIJUVA BIJUVA ANNOVERA Licensing Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Net Revenue Q3 2018 $3.5M Net Revenue Q3 2019 $23.7M Net Revenue Q2 2019 $6.1M
4 4 3Q19 Financial Results - Total Product Revenue Came in at Upper End of Guidance - FDA - Approved Products Net Revenue Prenatal Vitamins Net Revenue Total TXMD Product Net Revenue 3Q2019 Guidance 3Q2019 Financial Results $4.50 - $6.50M $2.25 - $2.50M $6.75 - $9.00M ▪ As our sales force focus shifts to our FDA - approved products and payer headwinds continue to increase for prenatal vitamins, we anticipate prenatal vitamins will continue to become a smaller percentage of overall company revenues $5.7M $2.5M $8.2M
5 5 14,500 46,500 75,100 106,700 135,000 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Net Revenue vs. Sales of Units to Patients IMVEXXY NET REVENUE IMVEXXY TRX 53% 27% 1. Total prescription data is based on IQVIA prescriber level data plus additional unique patient data identified through utiliz ati on of our affordability program. This includes up to two weeks of estimation for the lag in reporting retail data, which can cause minor fluctuations in historical comparisons. IMVEXXY Net Revenue Growth Faster than Unit Growth 55% 42% 137% 61% $2.0M $0.9M $0.2M $4.8M $3.1M
6 6 $134,000 $490,000 4,700 15,800 Q2 2019 Q3 2019 Net Revenue vs. Sales of Units to Patients BIJUVA NET REVENUE BIJUVA TRX BIJUVA Net Revenue Growth Faster than Unit Growth 265% 236% 1. Total prescription data is based on IQVIA prescriber level data plus additional unique patient data identified through utiliz ati on of our affordability program. This includes up to two weeks of estimation for the lag in reporting retail data, which can cause minor fluctuations in historical comparisons.
7 7 ANNOVERA LAUNCH INSIGHTS ▪ ANNOVERA launched late in third quarter with recorded sales of $400,000 ▪ Initial average net revenue of ~$1,250 per unit
8 8 Financial Summary ▪ Operating expenses – SG&A expenses ▪ Net loss and basic & diluted per share
9 9 Cash Balance at End of Each Quarter (Millions) $107.4 $154.4 $190.0 $161.6 $122.9 $182.9 $155.3 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019
10 10 Proforma Cash Balance at End of Each Quarter with Equity Raise (Millions) $107.4 $154.4 $190.0 $161.6 $122.9 $182.9 $155.3 $77.0 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Proforma Cash $232.3M Equity Raise
11 11 Non - Dilutive Term Loan Financing Amount ($) TXMD Company Milestone 1 Contractual Timing Tranche 1 $200M Closing of the facility Completed in April 2019 Tranche 2 $50M Designation of ANNOVERA as a new category of birth control by the U.S. Food and Drug Administration on or prior to December 31, 2019 4Q 2019 Tranche 3 $50M Achieving $11M in net revenues from IMVEXXY, BIJUVA and ANNOVERA for the fourth quarter of 2019 First Quarter of 2020 Audited financials required (Feb/Mar 2020) $200M accessed to date with up to additional $100M through Specific Company Milestones 1. TXMD Company Milestones are draw triggers for additional tranches of funding only and are not affirmative covenants that the company must otherwise meet. Ability to draw additional tranches is also subject to satisfaction (or waiver) of other customary conditions precedent.
12 12 Reaffirm 4Q2019 Financial Guidance FDA - Approved Products Net Revenue Prenatal Vitamins Net Revenue Total TXMD Product Net Revenue 4Q2019 Estimate Important Guidance Notes: ▪ As our sales force focus shifts to our FDA - approved products and payer headwinds continue to increase for prenatal vitamins, we anticipate prenatal vitamins will continue to become a smaller percentage of overall company revenues $11.00 - $13.00M $1.75 - $2.25M $12.75 - $15.25M
13 13 COMMERCIAL UPDATE
14 14 * Calculated Net Revenue per Unit = GAAP Net Revenue divided by number of Prescriptions filled by patients in period $15 $18 $27 $29 $35 15% 21% 26% 34% 38% 52% Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 (Est) CALCULATED IMVEXXY NET REVENUE PER UNIT IMVEXXY OVERALL ADJUDICATION RATE Estimated $48 - $52 IMVEXXY Calculated Net Revenue Per Unit Increases as Adjudication Rates Increases ▪ Start of copay optimization on 10/1/19 increased cost from $35 to $50 for non - covered patients ▪ Cost of copay program anticipated to continue to decrease for fourth quarter as patients with high deductible plans meet their OOP ▪ Overall adjudication rate in October increased 14% over 3Q19
15 15 Improvement in Adjudication Rates 2Q19 3Q19 Sept 2019 Oct 2019 Commercial Adjudication % 50% 55% 62% 72% Medicare Part D Adjudication % 8% 12% 13% 17% Overall % 34% 38% 43% 52% ▪ Addition of CVS in September contributing to overall adjudication rates ▪ Adjudication in Commercial Patients at 72% in October
16 16 BIJUVA Calculated Net Revenue Per Unit Increases as Adjudication Rates Increase $29 $31 34% 45% 56% Q2 2019 Q3 2019 Q4 2019 (Est) CALCULATED BIJUVA NET REVENUE PER UNIT BIJUVA OVERALL ADJUDICATION RATE Estimated $40 - $46 * Calculated Net Revenue per Unit = GAAP Net Revenue divided by number of Prescriptions filled by patients in period ▪ Start of copay optimization on 10/1/19 increased cost from $35 to $50 for non - covered patients ▪ Cost of copay program anticipated to continue to decrease for fourth quarter as patients with high deductible plans meet their OOP ▪ Overall adjudication rate in October increased 11% over Q3
17 17 2Q19 3Q19 Sept 2019 Oct 2019 Commercial Adjudication % 38% 50% 54% 62% Medicare Part D Adjudication % 7% 15% 14% 21% Overall % 34% 45% 49% 56% ▪ Addition of United, OptumRx in August and Cigna in September contributing to overall adjudication rates Improvement in Adjudication Rates
18 18
19 19 ANNOVERA Commercial Payer Update Already Achieved ~62% Unrestricted Access 1 Plan % of Lives 2 Status 3 CVS 16% Adjudicating with no copay as of October 2019 ESI 16% Adjudicating at T3 as of September 2019 United 8% In discussions Anthem 7% Adjudicating at T3, no copay as of August 2019 Prime 6% In discussions OptumRx 6% In discussions Kaiser 5% In discussions Aetna 4% No copay at in network pharmacies for a majority of lives as of October 2019 Cigna 4% Adjudicating at T3 as of August 2019 EnvisionRx 2% Adjudicating as of November 2019 Top 10 Plans Account for ~74% of all Commercial Pharmacy Lives 1 Adjudication of claim by payer: ANNOVERA is on payer formulary as covered product and is being submitted to insurance company for payment by payer to pharmacy. 1 MMIT November 2019 (Account Insights) and CVS Preventative Drug List 2 Plan numbers as of October 2019 3 Adjudication status from MMIT November 2019 and Account Insights New Kaiser Washington covering at no copay New New
20 20 ANNOVERA Status STARTED SOFT - LAUNCH 36 REPS + SALES MANAGEMENT PILLPACK PARTERSHIP LAUNCHED 4Q19 EXPECTED NET REVENUE PER UNIT RANGE $1,250 to $1,400
No Image 21 21 CONTRACEPTION PRENATAL CARE CONTRACEPTION/ FAMILY PLANNING - PERIMENOPAUSE VASOMOTOR SYMPTOMS DYSPAREUNIA (Vulvar & Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT Prenatal Vitamins The Power of a Women’s Health Portfolio
22 22
23 23 APPENDIX
24 24 ANNOVERA Deal Terms ▪ Upon FDA approval: $20M ▪ First commercial batch release: $20M ▪ $200M in cumulative net sales: $40M ▪ $400M in cumulative net sales: $40M ▪ $1B in cumulative net sales: $40M Milestone Payments Royalty % Step structure: ▪ Annual net sales < $50M: 5% ▪ Annual net sales > $50M and < $150M: 10% ▪ Annual net sales > $150M: 15% ▪ TXMD and Population Council jointly responsible for one observational PMR study * Additional Cost Considerations *Costs exceeding $20M to be shared with Population Council
25 25 3Q 2019 Key Performance Metrics ▪ IMVEXXY net revenue totaled $4.8M for 3Q19 (up from $3.1M for 2Q19) ▪ Net revenue continues to grow faster than units due to improving adjudication rates ▪ TRx increased 26% to ~ 134,000 units for 3Q19 (up from106,000 for 2Q19) ▪ Overall adjudication increased to 38% (up from 34% for 2Q19) IMVEXXY ANNOVERA BIJUVA ▪ BIJUVA net revenue totaled $491,000 for 3Q19 (up from $134,000 for 2Q19) ▪ TRx increased to 15,800 units for 3Q19 (up from 4,600 for 2Q19) ▪ Overall adjudication increased to 45% (up from 34% for 2Q19) ▪ ANNOVERA net revenue totaled $400,000 for 3Q19 ▪ Strong initial commercial net revenue of ~$1,250 per unit with the potential for improvement 2 1 $1,250 assumes patients meeting the criteria of 1) commercially insured patient or 2) approved via a Medical Necessity Letter . D oes not include cash pay sales.
26 26 IMVEXXY Launch Metrics Total paid scripts 1 (October 1 - 31, 2019) ~41,500 Total patients (since launch through October 31, 2019) ~103,900 Total prescribers 2 (since launch through October 31, 2019) ~16,400 IMVEXXY October Launch Metrics 1 Total prescription data is based on IQVIA prescriber level data plus additional unique patients identified through utilization of o ur affordability program. This includes up to two weeks of estimation for the lag in reporting retail data, which can cause minor fluctuations in historical comparisons. 2 Total Unique Prescribers that have sent a prescription to a pharmacy for at least 1 patient for IMVEXXY.
27 27 Launch Results Remain Strong References: 1. Total prescription data is based on IQVIA prescriber level data plus additional unique patient data identified through utiliz ati on of our affordability program. This includes up to two weeks of estimation for the lag in reporting retail data, which can cause minor fluctuations in historical comparisons. 2. Osphena and Intrarosa data sourced from Symphony Health Integrated Dataverse . 3. Vagifem data sourced from IQVIA National Prescriber Level Data. 4. Market share data based on IQVIA prescriber level data plus additional unique patient data identified through utilization of our affordability program. All trademarks are the property of their respective owners. *Month 16 for IMVEXXY is October 2019 % Market Share Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12 Month 13 Month 14 Month 15 Month 16 Month 17 Month 18 Imvexxy 200 6,300 8,400 13,300 14,400 19,800 23,500 23,600 28,100 31,200 37,700 37,500 45,500 44,600 44,900 41,500 Vagifem 25mcg 300 3,500 8,800 12,600 17,800 21,000 24,000 26,700 28,700 36,200 37,200 43,200 45,900 47,900 52,600 48,700 57,700 56,500 Osphena 0 700 1,700 2,700 3,500 5,100 6,100 7,300 9,200 10,500 13,300 14,500 16,600 18,100 19,000 19,400 19,800 20,800 Intrarosa 100 1,400 2,400 3,900 5,100 6,300 6,900 7,600 9,700 10,600 12,600 13,800 14,700 16,500 16,100 19,200 19,200 20,600 Market Share 0.0% 1.3% 1.9% 2.7% 3.0% 4.0% 4.9% 5.7% 6.0% 6.6% 7.7% 7.9% 9.0% 8.8% 9.1% 8,400 19,800 28,100 37,500 44,600 44,900 41,500 8,800 21,000 28,700 43,200 47,900 52,600 48,700 57,700 56,500 1.9% 4.0% 6.0% 7.9% 9.1% -4.0% -2.0% 0.0% 2.0% 4.0% 6.0% 8.0% 10.0% 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 Imvexxy TRx Launch Comparison *Month 16 for IMVEXXY is October 2019 % Market Share
28 28 Continued Strong Patient Adherence IMVEXXY: 4.0 fills/yr 3 (through Oct) • Vaginal creams: average 1.5 fills/yr 4 • Vaginal tablets: average 3.5 fills/yr 4 IMVEXXY Patient Adherence 1,2 Month Initial Prescription Filled Average # Fills for Those Patients Maximum Allowable Fills Given the Month of Initial Fill Oct 2019 1 Fill 1 Fill Sep 2019 1.7 Fills 2 Fills Aug 2019 2.3 Fills 3 Fills Jul 2019 2.9 Fills 4 Fills Jun 2019 3.3 Fills 5 Fills May 2019 3.7 Fills 6 Fills Apr 2019 4.3 Fills 7 Fills Mar 2019 4.8 Fills 8 Fills Feb 2019 5.2 Fills 9 Fills Jan 2019 5.7 Fills 10 Fills Dec 2018 6.0 Fills 11 Fills Nov 2018 6.7 Fills 12 Fills Oct 2018 6.8 Fills 13 Fills Sep 2018 7.2 Fills 14 Fills Aug 2018 8.5 Fills 15 Fills 1) Average number of fills per patient is the average number of fills per patient grouped by their initial month on therapy. 2) Total prescription data is based on IQVIA prescriber level data plus additional unique patients identified through utiliza tio n of our affordability program. 3) Average number of fills for all patients is calculated as Total Rx / Total Patients. 4) Total Rx/Patient Count Example of calculation: For patients who filled their initial prescription in November 2018, each of those patients averaged 6.7 fills from November 2018 through October 2019
29 29 Commercial Payer Status Achieved ~68% Unrestricted Commercial Access 1 9 of the Top 10 Commercial Payers Secured Plan % of Lives 2 Status 3 CVS 16% Adjudicating as of September 2019 ESI 16% Adjudicating as of 10/1/18 United 8% Adjudicating as of 3/1/19 Anthem 7% Adjudicating as of August 2018 Prime 6% Adjudicating as of 1/1/19 OptumRx 6% Adjudicating as of 1/1/19 Kaiser 5% In discussions Aetna 4% Adjudicating as of 1/1/2020 on a majority of plan designs Cigna 4% Adjudicating as of 12/15/18 EnvisionRx 2% Adjudicating as of 1/1/19 Top 10 Plans Account for ~74% of all Commercial Pharmacy Lives 1 Adjudication of claim by payer: IMVEXXY is on payer formulary as covered product and is being submitted to insurance company for payment by payer to pharmacy. 1 MMIT November 2019 (Account Insights) 2 Plan numbers as of October 2019 2 Adjudication status from MMIT November 2019 and Account Insights New New
30 30 Medicare Part D Payer Status Additional Decisions Expected This Quarter Plan % of Lives 2 Status 3 United 21% Adjudicating as of 2/1/19 Humana 18% Decision expected 4Q19 CVS Caremark 14% Decision expected 4Q19 Wellcare with Aetna lives 14% Decision expected 4Q19 Express Scripts/ Cigna 8% Decision expected 4Q19 Kaiser 4% Adjudicating maintenance pack as of 10/1/18 and starter pack as of 3/1/19 Anthem 3% Decision expected 4Q19 Envision 1% Decision expected 4Q19 Top 8 Plans Account for ~ 83 % of all Medicare Part D Pharmacy Lives 1 Adjudication of claim by payer: IMVEXXY is on payer formulary as covered product and is being submitted to insurance company for payment by payer to pharmacy. 1 MMIT November 2019 (Account Insights) 2 Plan numbers as of October 2019 3 Adjudication status from MMIT November 2019 and Account Insights
31 31 BIJUVA Update ▪ TXMD plans to submit a New Drug Application (NDA) supplement for the 0.5/100 mg dose of BIJUVA to FDA for approval ▪ After meeting with FDA, TXMD plans to submit an NDA efficacy supplement using existing REPLENISH Phase 3 data with new analyses ▪ Anticipate no new clinical trials required ▪ Plan to submit efficacy supplement in 4Q19 ▪ 10 month PDUFA date expected if the efficacy supplement is accepted for review ▪ Similar to IMVEXXY, TXMD expects vast majority of prescriptions to be the higher dose (1/100 mg) ▪ We believe a subset of healthcare providers would prescribe a lower dose option when titrating patients off of hormone replacement therapy (HRT), specifically in the BIO - IGNITE channel Plan to Submit BIJUVA 0.5/100 mg Dose Reason for Submission
32 32 BIJUVA Commercial Payer Update Additional Coverage Decisions Expected This Quarter Plan % of Lives 2 Status 3 CVS 16% In discussions ESI 16% Adjudicating as of 4/19/19 United 8% Adjudicating as of 8/1/19 Anthem 7% In discussions Prime 6% In discussions OptumRx 6% Adjudicating as of 8/1/19 Kaiser 5% In discussions Aetna 4% Adjudicating as of 4/2019 Cigna 4% Adjudicating as of 9/2019 EnvisionRx 2% Adjudicating as of 11/2019 Top 10 Plans Account for ~74% of all Commercial Pharmacy Lives 1 Adjudication of claim by payer: BIJUVA is on payer formulary as covered product and is being submitted to insurance company for payment by payer to pharmacy. Achieved ~55% Unrestricted Commercial Access 1 6 of the Top 10 Commercial Payers Secured 1 1 MMIT November 2019 and Account Insights 2 Plan numbers as of October 2019 3 Adjudication status from MMIT November 2019 and Account Insights New New
33 33 BIJUVA October Launch Metrics BIJUVA Launch Metrics Total paid scripts dispensed to patients 1 (since launch through October 31, 2019) ~26,900 Total paid scripts (October 1 - 31, 2019) ~6,500 Total patients (since launch through October 31, 2019) ~11,300 Total prescribers 2 (since launch through October 31, 2019) ~4,200 1 Total prescription data is based on IQVIA prescriber level data plus additional unique patients identified through utilization of o ur affordability program. This includes up to two weeks of estimation for the lag in reporting retail data, which can cause minor fluctuations in historical comparisons. 2 Total Unique Prescribers that have sent a prescription to a pharmacy for at least 1 patient for BIJUVA.
34 34 ANNOVERA Commercial Payer Update Already Achieved ~62% Unrestricted Access 1 Plan % of Lives 2 Status 3 CVS 16% Adjudicating with no copay as of October 2019 ESI 16% Adjudicating at T3 as of September 2019 United 8% In discussions Anthem 7% Adjudicating at T3, no copay as of August 2019 Prime 6% In discussions OptumRx 6% In discussions Kaiser 5% In discussions Aetna 4% No copay at in network pharmacies for a majority of lives as of October 2019 Cigna 4% Adjudicating at T3 as of August 2019 EnvisionRx 2% Adjudicating as of November 2019 Top 10 Plans Account for ~74% of all Commercial Pharmacy Lives 1 Adjudication of claim by payer: ANNOVERA is on payer formulary as covered product and is being submitted to insurance company for payment by payer to pharmacy. 1 MMIT November 2019 (Account Insights) and CVS Preventative Drug List 2 Plan numbers as of October 2019 3 Adjudication status from MMIT November 2019 and Account Insights New Kaiser Washington covering at no copay New New
35 35 ANNOVERA Commercial Payer Update Fast Uptake in Regional Plans Selected Regional Plan Coverage Adjudication of claim by payer: ANNOVERA is on payer formulary as covered product and is being submitted to insurance company for payment by payer to pharmacy. 1 Plan numbers as of October 2019 2 MMIT October 2019 and Account Insights Plan % of Lives 1 Status 2 MC - Rx (ProcareRx) 0.64% Adjudicating as of April 2019 Magellan Rx 0.4% Adjudicating as of August 2019 BCBS of Massachusetts 0.47% Adjudicating at no copay as of August 2019 EmblemHealth 0.26% Adjudicating at no copay as of September 2019 Excellus 0.24% Adjudicating as of September 2019 Wellmark 0.23% Adjudicating as of August 2019 Harvard Pilgrim 0.18% Adjudicating at no copay as of August 2019 Independent Health Association 0.06% Adjudicating as of August 2019 Geisinger 0.05% Adjudicating at no copay as of October 2019 BC of Idaho 0.00% Adjudicating at no copay as of September 2019 Summacare 0.00% Adjudicating at no copay as of September 2019 Clear Script PBM 0.00% Adjudicating as of August 2019 Univera Healthcare 0.00% Adjudicating as of August 2019 New
36 36 Total Addressable Birth Control Market NRx: 28M Average Net Revenue / Unit 1.0% 1.5% 2.0% 2.5% $1,000 $280M $420M $560M $700M $1,250 $350M $525M $700M $875M $1,500 $420M $630M $840M $1.05B $1,750 $490M $735M $980M $1.2B Percent of Market Based on Patient Count of 2.3M and 4 fills per year Average Net Revenue / Unit 25% 35% 45% 55% $80 $184M $257.6M $331.2M $404.8M $100 $230M $322M $414M $506M Total Addressable FDA Market : 3.8M Total Addressable Compounding Market : 12M Percent of Addressable Market Average Net Revenue / Unit 25% 35% 45% 55% $80 $316M $442.4M $568.8M $695.2M $100 $395M $553M $711M $869 M The Power of the Portfolio Multiple Paths to $1B of Peak Sales Diversified risk with 3 FDA - approved products, creating multiple paths to $1B peak sales opportunity Example: $230M (IMVEXXY), $395M (BIJUVA) and $420M (ANNOVERA) = $1B peak sales potential