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:
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 February 20, 2020, TherapeuticsMD, Inc. (the "Company") issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 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 2.03 | Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet |
Arrangement of a Registrant.
On February 18, 2020, the Company completed the draw-down of the first additional tranche of $50 million (the “Additional Tranche”) under its previously announced $300 million term loan facility with TPG Specialty Lending, Inc., as administrative agent, various lenders from time to time party thereto, and certain of the Company’s subsidiaries party thereto from time to time as guarantors, dated as of April 24, 2019, as amended (the “Financing Agreement”). The Additional Tranche became available to the Company upon the Company achieving $11 million in net revenues from the Company’s IMVEXXY®, BIJUVA®, and ANNOVERA® products for the fourth quarter of 2019.
Summaries of the material terms of the Financing Agreement are included in Item 1.01 of the Company’s Current Reports on Form 8-K, filed on April 25, 2019 and December 30, 2019, and are incorporated herein by reference.
| Item 7.01 | Regulation FD Disclosure. |
On February 20, 2020, the Company issued a press release announcing the Company’s financial results for its fourth quarter and full year ended December 31, 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 February 20, 2020, entitled "TherapeuticsMD Announces Fourth Quarter and Full-Year 2019 Financial Results." | |
| 99.2 | TherapeuticsMD, Inc. Presentation dated February 20, 2020.
| |
| 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: | February 20, 2020 | By: | /s/ Daniel A. Cartwright |
Name: |
Daniel A. Cartwright | ||
| Title: | Chief Financial Officer | ||
Exhibit 99.1
FOR IMMEDIATE RELEASE
TherapeuticsMD Announces Fourth Quarter and Full-Year 2019 Financial Results
- 4Q19 Total Net Product Revenue of $15.9 Million Exceeded the Company’s Financial Guidance-
- Full-Year 2019 Total Net Product Revenue of $34.1 Million at the Top End of Financial Guidance-
-Company Launched ANNOVERA, a Novel, Long-Lasting Contraceptive-
- Company Expects Full-Year 2020 Net Product Revenue of $90 Million to $110 Million -
- Conference Call Scheduled for 8:30 a.m. ET Today -
BOCA RATON, Fla. – February 20, 2020 – TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the full-year and fourth quarter ended December 31, 2019 and provided 2020 financial guidance.
“I am very pleased with our commercial team’s execution in 2019, which has put us in a strong position for 2020. We ended the year exceeding our fourth quarter net revenue guidance and achieved the top end of our full-year guidance,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. “Our goal is to build on this momentum as we make additional investments in our products to generate a significant revenue inflection point in 2020.”
Fourth Quarter & Recent Highlights
|
|
● |
Net product revenue for the fourth quarter of 2019 increased 94% to $15.9 million compared to the third quarter of 2019. |
|
|
● |
ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system) achieved net revenue of $5.8 million for the fourth quarter of 2019 from sales to wholesalers and pharmacies with an average net revenue per unit of approximately $1,350. |
|
|
● |
ANNOVERA has already achieved market access for the majority of lives under commercial plans with 75% commercial coverage. |
|
|
● |
IMVEXXY® (estradiol vaginal inserts) fourth quarter 2019 net revenue increased by 33% to $6.3 million compared to the third quarter of 2019. In the fourth quarter of 2019, approximately 123,000 IMVEXXY prescriptions were dispensed and paid for by patients. Average calculated net revenue per unit was approximately $51 for the fourth quarter of 2019. Strong IMVEXXY refill rates continued with patients adhering to therapy at an average rate of 4.4 fills through December 2019. Those patients on IMEXXY for one year averaged over six fills. |
|
|
● |
IMVEXXY has market access for the majority of lives under commercial plans with 72% unrestricted commercial coverage. IMVEXXY is now covered by all of the top ten commercial payors of vulvar and vaginal atrophy (VVA) products. Three of the top six Medicare Part D payors of VVA products cover IMVEXXY. Additional Medicare coverage is expected when the 2020 decisions are made for this class of products. |
|
|
● |
BIJUVA® (estradiol and progesterone) capsules fourth quarter 2019 net revenue increased 147% to $1.2 million compared to the third quarter of 2019. In the fourth quarter of 2019, approximately 22,000 prescriptions were dispensed and paid for by patients. Average calculated net revenue per unit was $56 for the fourth quarter of 2019. |
|
|
● |
BIJUVA has market access for the majority of lives under commercial plans with 56% commercial coverage. BIJUVA is covered by seven of the top ten commercial payors of vasomotor symptoms (VMS) products. |
Fourth Quarter and Full-Year Revenue Performance
For the year ended December 31, 2019, net product revenue increased 112% to $34.1 million compared to $16.1 million for the prior year. Net product revenue for the fourth quarter of 2019 increased 94% to $15.9 million compared to $5.1 million for the prior year’s quarter.
|
|
|
Three Months |
|
|
Twelve Months |
|
||||||||||
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
||||
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|||||||
|
Prenatal vitamins |
|
$ |
2,576,319 |
|
|
$ |
4,243,398 |
|
|
$ |
9,885,493 |
|
|
$ |
15,041,259 |
|
|
IMVEXXY |
|
|
6,347,301 |
|
|
|
846,125 |
|
|
|
16,252,045 |
|
|
|
1,058,201 |
|
|
BIJUVA |
|
|
1,211,456 |
|
|
|
— |
|
|
|
1,836,443 |
|
|
|
— |
|
|
ANNOVERA |
|
|
5,766,604 |
|
|
|
— |
|
|
|
6,166,556 |
|
|
|
— |
|
|
License revenue |
|
|
— |
|
|
|
— |
|
|
|
15,506,400 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue |
|
$ |
15,901,680 |
|
|
$ |
5,089,523 |
|
|
$ |
49,646,937 |
|
|
$ |
16,099,460 |
|
Net product revenue increased primarily due to an increase in sales of $15.2 million of IMVEXXY for the year ended December 31, 2019, partially offset by a decrease in prenatal vitamin sales of $5.2 million. Product revenue for the year ended December 31, 2019 also included sales of BIJUVA of $1.8 million and sales of ANNOVERA of $6.2 million. The decrease in revenue related to our prenatal vitamins was primarily affected by a lower number of units sold as compared to the prior year period.
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. The company expects net product revenue to improve as commercial and Medicare payor coverage increases, and plans complete the process needed to adjudicate IMVEXXY, BIJUVA and ANNOVERA prescriptions at pharmacies.
Expense, EPS and Related Information
Research and development (R&D) expenses for the full-year 2019 decreased to $19.8 million, compared with $27.3 million for the prior year. R&D expenses for the fourth quarter of 2019 were $4.4 million compared with $6.8 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 for the full-year 2019 increased to $174.1 million compared with $116.0 million for the prior year. SG&A expenses increased to $52.7 million for the fourth quarter of 2019 compared with $35.4 million for the prior year’s quarter. The increase in SG&A expenses for full-year and fourth 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.
Net loss for the full-year 2019 was $176.1 million, or $0.72 per basic and diluted share, compared with $132.6 million, or $0.59 per basic and diluted share, for full-year 2018. For the fourth quarter of 2019, net loss increased to $49.4 million, or $0.19 per basic and diluted share, compared with $39.4 million, or $0.17 per basic and diluted share, for the fourth quarter of 2018.
Balance Sheet
As of December 31, 2019, the company’s cash on hand totaled approximately $160.8 million, compared with approximately $161.6 million at December 31, 2018.
Total outstanding debt, net of issuance costs, was approximately $194.6 million as of December 31, 2019.
On February 18, 2020, the company received the second tranche of funding under its financing agreement with TPG Specialty Lending, Inc. in the amount of $50 million following the company’s achievement of $11 million in net revenues from IMVEXXY, BIJUVA, and ANNOVERA for the fourth quarter of 2019.
2020 Financial Guidance
The company projects that product net revenue for 2020 will be between $90 million to $110 million. The company projects that product net revenue during the second half of the year will be significantly larger than the first half with the majority of 2020 product net revenue coming from ANNOVERA and IMVEXXY. The company anticipates high deductible and annual copay resets will impact first quarter of 2020 revenue for its menopause products and expects first quarter 2020 product net revenue to come in below fourth quarter 2019 product net revenue.
Conference Call and Webcast Details
TherapeuticsMD will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss these financial results and provide a business update.
|
Date: |
Thursday, February 20, 2020 |
|
Time: |
8:30 a.m. ET |
|
Telephone Access (US): |
866-665-9531 |
|
Telephone Access (International): |
724-987-6977 |
|
Access Code for All Callers: |
7359398 |
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: 7359398.
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 |
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 an additional tranche thereunder and whether the lender will make such tranche available; 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; whether the FDA will approve the efficacy supplement for the lower dose of BIJUVA; 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 ability of the company’s marketing contractors to market ANNOVERA; 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
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 160,829,713 | $ | 161,613,077 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $904,040 and $596,602, respectively | 24,395,958 | 11,063,821 | ||||||
| Inventory | 11,860,716 | 3,267,670 | ||||||
| Other current assets | 11,329,793 | 10,834,693 | ||||||
| Total current assets | 208,416,180 | 186,779,261 | ||||||
| Fixed assets, net | 2,507,775 | 472,683 | ||||||
| Other Assets: | ||||||||
| License rights, net | 39,221,308 | 20,000,000 | ||||||
| Intangible assets, net | 5,258,211 | 4,092,679 | ||||||
| Right of use asset | 10,109,154 | — | ||||||
| Other current assets | 473,009 | 639,301 | ||||||
| Total other assets | 55,061,682 | 24,731,980 | ||||||
| Total assets | $ | 265,985,637 | $ | 211,983,924 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 19,181,212 | $ | 22,743,841 | ||||
| Other current liabilities | 33,823,613 | 18,334,948 | ||||||
| Total current liabilities | 53,004,825 | 41,078,789 | ||||||
| Long-Term Liabilities: | ||||||||
| Long-term debt | 194,634,643 | 73,381,014 | ||||||
| Operating lease liability | 9,145,049 | — | ||||||
| Total liabilities | 256,784,517 | 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: 271,177,076 and 240,462,439 issued and outstanding, respectively | 271,177 | 240,463 | ||||||
| Additional paid-in capital | 704,351,222 | 616,559,938 | ||||||
| Accumulated deficit | (695,421,279 | ) | (519,276,280 | ) | ||||
| Total stockholders’ equity | 9,201,120 | 97,524,121 | ||||||
| Total liabilities and stockholders’ equity | $ | 265,985,637 | $ | 211,983,924 | ||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||||||
| 2019 | 2018 | 2019 | 2018 | 2017 | ||||||||||||||||
| Product revenues, net | $ | 15,901,680 | $ | 5,089,523 | $ | 34,140,537 | $ | 16,099,460 | $ | 16,777,713 | ||||||||||
| License revenue | — | — | 15,506,400 | — | — | |||||||||||||||
| 15,901,680 | 5,089,523 | 49,646,937 | 16,099,460 | 16,777,713 | ||||||||||||||||
| Cost of goods sold | 2,878,590 | 950,750 | 6,334,585 | 2,737,652 | 2,636,943 | |||||||||||||||
| Gross profit | 13,023,090 | 4,138,773 | 43,312,352 | 13,361,808 | 14,140,770 | |||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Sales, general, and administrative | 52,734,093 | 35,410,875 | 174,112,612 | 115,988,954 | 57,703,370 | |||||||||||||||
| Research and development | 4,432,224 | 6,753,190 | 19,792,212 | 27,299,138 | 33,852,993 | |||||||||||||||
| Depreciation and amortization | 248,830 | 95,341 | 612,786 | 293,886 | 213,117 | |||||||||||||||
| Total operating expenses | 57,415,147 | 42,259,406 | 194,517,610 | 143,581,978 | 91,769,480 | |||||||||||||||
| Operating loss | (44,392,057 | ) | (38,120,633 | ) | (151,205,258 | ) | (130,220,170 | ) | (77,628,710 | ) | ||||||||||
| Other (expense) income | ||||||||||||||||||||
| Loss on extinguishment of debt | — | — | (10,057,632 | ) | — | — | ||||||||||||||
| Miscellaneous income | 621,126 | 823,027 | 2,500,106 | 2,280,844 | 695,631 | |||||||||||||||
| Interest expense | (5,664,583 | ) | (2,093,375 | ) | (17,382,215 | ) | (4,677,834 | ) | — | |||||||||||
| Accreted interest | — | — | — | — | 7,699 | |||||||||||||||
| Total other (expense) income | (5,043,457 | ) | (1,270,348 | ) | (24,939,741 | ) | (2,396,990 | ) | 703,330 | |||||||||||
| Loss before income taxes | (49,435,514 | ) | (39,390,981 | ) | (176,144,999 | ) | (132,617,160 | ) | (76,925,380 | ) | ||||||||||
| Provision for income taxes | — | — | — | — | — | |||||||||||||||
| Net loss | $ | (49,435,514 | ) | $ | (39,390,981 | ) | $ | (176,144,999 | ) | $ | (132,617,160 | ) | $ | (76,925,380 | ) | |||||
| Loss per share, basic and diluted: | ||||||||||||||||||||
| Net loss per share, basic and diluted | $ | (0.19 | ) | $ | (0.17 | ) | $ | (0.72 | ) | $ | (0.59 | ) | $ | (0.37 | ) | |||||
| Weighted average number of common shares outstanding, basic and diluted | 261,752,076 | 238,556,492 | 246,353,318 | 225,026,300 | 205,523,288 | |||||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Year Ended December, 31, | ||||||||||||
| 2019 | 2018 | 2017 | ||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||
| Net loss | $ | (176,144,999 | ) | $ | (132,617,160 | ) | $ | (76,925,380 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Depreciation of fixed assets | 415,193 | 181,412 | 141,601 | |||||||||
| Amortization of intangible assets | 197,593 | 112,474 | 71,516 | |||||||||
| Write off of patent and trademark cost | 78,864 | — | — | |||||||||
| Non-cash operating lease expense | 1,062,318 | — | — | |||||||||
| Provision for doubtful accounts | 307,438 | 216,022 | 4,206 | |||||||||
| Loss of extinguishment of debt | 10,057,632 | — | — | |||||||||
| Share-based compensation | 10,693,662 | 8,661,967 | 6,889,323 | |||||||||
| Amortization of intellectual property license fee | 778,692 | — | — | |||||||||
| Amortization of deferred financing costs | 856,302 | 269,859 | — | |||||||||
| Changes in operating assets and liabilities: | ||||||||||||
| Accounts receivable | (13,639,575 | ) | (6,951,041 | ) | 167,691 | |||||||
| Inventory | (8,593,046 | ) | (1,782,312 | ) | (409,037 | ) | ||||||
| Other assets | (1,880,048 | ) | (2,657,190 | ) | (4,434,130 | ) | ||||||
| Accounts payable | (3,562,629 | ) | 18,646,241 | (3,260,914 | ) | |||||||
| Accrued expenses and other liabilities | 13,675,008 | 9,107,947 | 1,599,510 | |||||||||
| Net cash used in operating activities | (165,697,595 | ) | (106,811,781 | ) | (76,155,614 | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||||
| Payment for intellectual property license | (20,000,000 | ) | (20,000,000 | ) | — | |||||||
| Patent costs | (1,441,989 | ) | (1,105,407 | ) | (765,291 | ) | ||||||
| Purchase of fixed assets | (2,450,285 | ) | (217,040 | ) | (61,817 | ) | ||||||
| Payment of security deposit | (20,420 | ) | (175,410 | ) | — | |||||||
| Net cash used in investing activities | (23,912,694 | ) | (21,497,857 | ) | (827,108 | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||
| Proceeds from exercise of options and warrants | 108,656 | 1,666,208 | 4,011,614 | |||||||||
| Proceeds from sale of common stock, net of costs | 77,031,258 | 89,907,797 | 68,572,635 | |||||||||
| Proceeds from Financing Agreement | 200,000,000 | — | — | |||||||||
| 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 | 188,826,925 | 162,787,087 | 72,584,249 | |||||||||
| (Decrease) increase in cash | (783,364 | ) | 34,477,449 | (4,398,473 | ) | |||||||
| Cash, beginning of period | 161,613,077 | 127,135,628 | 131,534,101 | |||||||||
| Cash, end of period | $ | 160,829,713 | $ | 161,613,077 | $ | 127,135,628 | ||||||
| Supplemental disclosure of cash flow information | ||||||||||||
| Interest paid | $ | 17,787,903 | $ | 1,890,166 | $ | — | ||||||
Exhibit 99.2
Building the Premier Women’s Health Company 4Q 2019 Earnings February 20, 2020
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 our 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 an additional tranche thereunder and whether our lender will make that tranche available ; 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 ; whether the FDA will approve the efficacy supplement for the lower dose of BIJUVA ; 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 ability of the company’s marketing contractors to market ANNOVERA ; 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, including the effect of any sales of common stock by our executive officers or directors, whether in connection with the expiration of stock options or otherwise ; and the concentration of power in our stock ownership . This non - promotional presentation is intended for investor audiences only .
3 Today’s Agenda 2019 Review 2020 Commercial Strategy and Marketing Plans 4Q 2019 Financial Results 2020 Financial Guidance Q&A
4 Foundational Elements to Accelerate Revenue Growth 2020 Portfolio Awareness & Education Broad Payor Access New Distribution Channels All trademarks are the property of their respective owners. VA/Military Public Health Puerto Rico
5 Net Revenue Actual vs Guidance Q2 2019 Q3 2019 Q4 2019 $5,500,000 $7,500,000 $13,000,000 $6,078,865 $8,213,341 $15,901,680 Net Revenue Actual vs Guidance Guidance - Midpointe Net Revenue - Product Sales High End Q3 2019 Q4 2019 $2,550,330 $2,576,319 $490,705 $1,211,456 $4,772,354 $6,347,301 $399,952 $5,766,604 Net Revenue by Product Prenatal Vitamins BIJUVA IMVEXXY ANNOVERA
6 Coverage Today February 20, 2020 Target Coverage Year - end 2020 ANNOVERA Commercial 75%* 80%* IMVEXXY Commercial 72% 75% Part D 29% 70% BIJUVA Commercial 56% 75% Significant Payor Coverage and Growing Source: MMIT February 20, 2020 Awaiting IMVEXXY Part D decisions from Humana, Wellcare and ESI; potential total unrestricted coverage of up to 40% by April 1 st *Annovera coverage includes unrestricted access and coverage with a step edit/prior authorization. Currently 65% unrestricted, 11% step/prior authorization.
PRODUCT OVERVIEW & COMMERCIAL UPDATES
8 Shifted from a clinically innovative company to a commercially successful company 3 Products in Launch Mode Q3 2018 Q2 2019 Q1 2020 COMMERCIAL LAUNCHES
9 Sales Force Redeployed to Provide More Effective Portfolio Coverage 150 Women’s Healthcare Specialists 30 - 40 Menopause Specialists 1 2 3 1 2
10 ANNOVERA – Patient - Controlled and Procedure - Free Long - Lasting Contraception* *ANNOVERA is inserted for 21 continuous days and removed for 7 days for 13 cycles (one year). IUDs Long - Lasting,* Reversible, Patient - Controlled, Procedure - Free Benefits of both long - lasting & short - acting contraception Long - acting benefits but requires a procedure for both insertion and removal ANNOVERA ® Implant Long - acting benefits but requires a procedure for both insertion and removal Short - acting Contraceptives Contraceptive protection with no long - lasting benefits (daily use required) (weekly use required) (monthly use required)
11 Sales Force Focus Consumer Advertising and Public Relations Effort ANNOVERA Growth Levers Lead Product for Spend and Focus 1 ANNOVERA is inserted for 21 continuous days and removed for 7 days for 13 cycles (one year) Expand into New Channels and Populations ▪ Focus on Empowerment and Control 1,2 ▪ Disruptive Consumer Campaign Launching in March ▪ Public Relations Initiatives ▪ Full scale launch planned for March 1 st ▪ Lead product designation for Women’s Healthcare Salesforce ▪ Online Platforms including Pillpack , PlushCare , and Pill Club ▪ WSI to market to the Department of Defense and Veteran’s Administration ▪ Puerto Rico Distribution ▪ Afaxys to meet the needs of public health clinics, college and university health clinics, and city, county, state and federal facilities
12 IMVEXXY Investment Across Multiple Levers *IQVIA data All trademarks are the property of their respective owners. 2020 Goal: surpass Premarin® Vaginal Cream on a monthly prescription basis by year end ▪ Current average monthly TRX of Premarin Vaginal Cream: 80K TRx * ▪ Promoted by all Sales Representatives ▪ 4,200 current heavy writers representing 20% of high volume VVA writers ▪ Goal to increase depth of writing among 20,000 prescribers who have prescribed IMVEXXY ▪ Increased overall funding ▪ Heavier investment in consumer marketing throughout the year Marketing Sales Force
13 Targeted approach supporting BIO - IGNITE 163 pharmacies live A dedicated team of sales reps and the TXMD BIO - IGNITE staff will focus their efforts to grow BIJUVA through BIO - IGNITE partners Menopause Specialist Deployment Potential Second Dose PDUFA November 2020 BIJUVA Targeted Approach in 2020 Preparing for Full Launch in 2021
14 Chris Gish – Sales Lead ▪ Senior Sales Leader with 29 years of experience in pharmaceutical sales leadership ▪ Experience in large and small pharmaceutical companies including Pfizer, Sunovion, Alder - Bio ▪ Have launched 20+ brands over the course of his career ▪ Unique expertise in optimizing pharmaceutical sales organizations Build out of Commercial Expertise Commercial Leadership Team Mike Steelman – Market Access Lead ▪ Senior leader access positions at Pfizer and Sanofi with United States and International responsibility ▪ 22 years of pharma experience with 13 years in access ▪ Was responsible for 1/3 of Pfizer’s National Payor Accounts including government sector Dedra Lyden – Strategic Partnerships ▪ Launched and continues to lead the expansion of Bio - Ignite ▪ 16 years of Pharmaceutical experience across BD, Sales, Sales leadership Tyra Riehl – Training Lead ▪ Senior leader with expertise in sales training and leadership development ▪ 22 years in small and large biotech and pharmaceutical companies including Searle, Sunovion, Quest and Alkermes Kristen Landon – Marketing Lead ▪ Women’s Health commercial leader with prior tenures at Allergan, Radius Health, and Sprout ▪ 24 years’ experience in pharmaceutical marketing, sales, sales leadership, and business development ▪ Category experience in contraception, menopause, osteoporosis, sexual dysfunction, infertility, and infections ▪ Brands include Lo Loestrin , Estrace , Tymlos , Generess , Liletta , ella , Addyi , Crinone , and Solosec Erika Guay – Menopause Brand Lead ▪ Senior leader with over 15 years of marketing experience at Pfizer ▪ Brand experience across multiple categories including, Women’s Health, Depression, Cardiovascular & Dermatology Jerrold McRae - Reproductive Brand Lead ▪ Sales and marketing and strategy leader at Pfizer for 14 years ▪ Brand experience across multiple categories including Women’s Health ( Estring ), Pain (Lyrica), Urology (Detrol LA, Viagra) All trademarks are the property of their respective owners.
FINANCIAL UPDATE
16 Net Revenue Actual vs Guidance Q2 2019 Q3 2019 Q4 2019 $5,500,000 $7,500,000 $13,000,000 $6,078,865 $8,213,341 $15,901,680 Net Revenue Actual vs Guidance Guidance - Midpointe Net Revenue - Product Sales High End
17 * 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% 54% Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 CALCULATED IMVEXXY NET REVENUE PER UNIT IMVEXXY OVERALL ADJUDICATION RATE $51 Trend in Total Net Revenue and Calculated Net Revenue Per Unit Q3 2019 Q4 2019 IMVEXXY $4,772,354 IMVEXXY $6,347,301 Net Revenue by Product Prenatal Vitamins BIJUVA IMVEXXY ANNOVERA
18 * Calculated Net Revenue per Unit = GAAP Net Revenue divided by number of prescriptions filled by patients in period $29 $31 34% 45% 60% Q2 2019 Q3 2019 Q4 2019 CALCULATED BIJUVA NET REVENUE PER UNIT BIJUVA OVERALL ADJUDICATION RATE $56 Q3 2019 Q4 2019 BIJUVA $490,705 BIJUVA $1,211,456 Net Revenue by Product Prenatal Vitamins BIJUVA IMVEXXY ANNOVERA Trend in Total Net Revenue and Calculated Net Revenue Per Unit
19 ANNOVERA Net Revenue Actual Q3 2019 Q4 2019 $399,952 $5,766,604 Prenatal Vitamins BIJUVA IMVEXXY ANNOVERA
20 Financial Summary ▪ Operating expenses – SG&A expenses ▪ Net loss and basic & diluted per share
21 Cash Balance at End of Each Quarter with Equity Raise/Debt Funding Post Quarter End Quarter End Cash Balance $155.33 Quarter End Cash Balance $160.83 Oct. 2019 Equity Raise $77 Feb. 2020 Debt Financing Draw $50 (Millions) Q3 2019 Q4 2019
22 Drive Net Revenues: Control Operating Expenses: ▪ Invest appropriate financial resources to drive net revenue growth for our brands 2020 Cost Containment Measures Goal to reinvest the savings into marketing initiatives ▪ Scrutinized internal cost structure and reduced spend on the following: ▪ Non - revenue generating projects ▪ Headcount optimization / reduction ▪ Eliminated multiple clinical development roles ▪ Paused pipeline development projects
23 Annual Net Revenue Guidance • Company projects 2020 net product revenue to be between $90M to $110M Key Assumptions: • Net product revenue during the second half of the year will be significantly larger than the first half with the majority coming from ANNOVERA and IMVEXXY • High deductible and annual copay resets expected to impact 1Q20 net revenue for the menopause products ‒ Expect 1Q20 net revenue to come in below 4Q19 net revenue ‒ 1Q20 industry wide headwind built into our annual 2020 financial guidance 2020 Financial Guidance * Note: In 2020, the company will utilize Symphony Health IDV national data for reporting prescriptions dispensed to patient’s by pharmacies as we believe Symphony Health data most accurately reflects the data.
24 • Full launch of ANNOVERA for TXMD’s sales force will begin on March 1 st • Leverage new distribution channels to enter new markets that create additional revenue opportunity outside TXMD’s direct sales and marketing efforts • For IMVEXXY, goal is to pass the VVA branded leader, Premarin vaginal cream, on a monthly prescription basis by the end of 2020 • For BIJUVA, utilize menopause specialist sales force to provide the right focus to build the foundation and allow us to scale BIJUVA in the coming years • Become EBITDA positive in 2021 2020 Goals & Milestones
25 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
26 CONTRACEPTION PRENATAL CARE CONTRACEPTION/ FAMILY PLANNING - PERIMENOPAUSE VASOMOTOR SYMPTOMS DYSPAREUNIA (Vulvar & Vaginal Atrophy) REPRODUCTIVE HEALTH MENOPAUSE MANAGEMENT Prenatal Vitamins Q&A