QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol |
Name of each exchange on which registered | ||
Large Accelerated Filer | ☐ | Accelerated filer | ☐ | |||
☒ | Smaller reporting company | |||||
Emerging growth company |
Page |
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Item. 1. |
Financial Statements (Unaudited) | |||||
Consolidated Balance Sheets | 1 | |||||
Consolidated Statements of Operations | 2 | |||||
Consolidated Statements of Stockholders’ Equity (Deficit) | 3 | |||||
Consolidated Statements of Cash Flows | 4 | |||||
Notes to Unaudited Consolidated Financial Statements | 5 | |||||
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 15 | ||||
Item 3. |
Quantitative and Qualitative Disclosures about Market Risk | 23 | ||||
Item 4. |
Controls and Procedures | 23 | ||||
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Item 1. |
Legal Proceedings | 24 | ||||
Item 1A. |
Risk Factors | 24 | ||||
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds | 24 | ||||
Item 3. |
Defaults Upon Senior Securities | 24 | ||||
Item 4. |
Mine Safety Disclosures | 24 | ||||
Item 5. |
Other Information | 24 | ||||
Item 6. |
Exhibits | 24 | ||||
26 |
March 31, 2021 |
December 2020 |
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(Unaudited) | ||||||||
Assets: |
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Current assets: |
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Cash |
$ | $ | ||||||
Accounts receivable, net of allowance of credit losses of $ |
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Inventory |
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Prepaid and other current assets |
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Total current assets |
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Fixed assets, net |
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License rights and other intangible assets, net |
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Right of use assets |
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Other non-current assets |
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Total assets |
$ | $ | ||||||
Liabilities and stockholders’ equity (deficit): |
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Current liabilities: |
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Current maturities of long-term debt |
$ | $ | — | |||||
Accounts payable |
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Accrued expenses and other current liabilities |
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Total current liabilities |
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Long-term debt, net |
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Operating lease liabilities |
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Total liabilities |
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Commitments and contingencies (Note 9) |
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Stockholders’ equity (deficit): |
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Preferred stock, par value $ |
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Common stock, par value $ and outstanding as of March 31, 2021 and December 31, 2020, respectively |
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Additional paid-in capital |
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Accumulated deficit |
( |
) | ( |
) | ||||
Total stockholders’ deficit |
( |
) | ( |
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Total liabilities and stockholders’ equity (deficit) |
$ | $ | ||||||
Three Months Ended March 31, |
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2021 | 2020 | |||||||
Product revenue, net |
$ | $ | ||||||
License revenue |
— | |||||||
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Total revenue, net |
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Cost of goods sold |
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Gross profit |
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Operating expenses: |
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Selling, general and administrative |
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Research and development |
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Total operating expenses |
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Loss from operations |
( |
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Other (expense) income: |
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Interest expense and other financing costs |
( |
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Other income, net |
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Other (expense), net |
( |
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Loss before income taxes |
( |
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Provision for income taxes |
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Net loss |
$ | ( |
) | $ | ( |
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Loss per common share, basic and diluted |
$ | ( |
$ | ( |
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Weighted average common shares, basic and diluted |
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Common Stock |
Additional Paid in Capital |
Accumulated Deficit |
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Shares |
Amount |
Total |
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Balance, January 1, 2021 |
$ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
Shares issued for sale of common stock, net of cost |
— | |||||||||||||||||||
Shares issued for exercise of warrants |
— | — | ||||||||||||||||||
Shares issued for vested restricted stock units |
— | — | — | — | ||||||||||||||||
Share-based compensation |
— | — | — | |||||||||||||||||
Net loss |
— | — | — | ( |
) | ( |
) | |||||||||||||
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Balance, March 31, 2021 |
$ | $ | $ | ( |
) | $ | ( |
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Balance, January 1, 2020 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
Shares issued for exercise of options |
— | — | ||||||||||||||||||
Shares issued for vested restricted stock units |
— | — | — | — | ||||||||||||||||
Share-based compensation |
— | — | — | |||||||||||||||||
Net loss |
— | — | — | ( |
) | ( |
) | |||||||||||||
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Balance, March 31, 2020 |
$ | $ | $ | ( |
) | $ | ( |
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Three Months Ended March 31, |
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2021 | 2020 | |||||||
Cash flows from operating activities: |
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Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Charges (credits) to provision for doubtful accounts |
( |
) | ||||||
Inventory charge |
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Debt financing fees |
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Non-cash operating lease expense |
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Share-based compensation |
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Changes in operating assets and liabilities |
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Accounts receivable |
( |
) | ||||||
Inventory |
( |
) | ||||||
Prepaid and other current assets |
( |
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Accounts payable |
( |
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Accrued expenses and other current liabilities |
( |
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Total adjustments |
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Net cash used in operating activities |
( |
) | ( |
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Cash flows from investing activities: |
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Payment of patent related costs |
( |
) | ( |
) | ||||
Purchase of fixed assets |
( |
) | ( |
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Net cash used in investing activities |
( |
) | ( |
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Cash flows from financing activities: |
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Proceeds from sale of common stock, net of costs |
— | |||||||
Proceeds from exercise of options and warrants |
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Repayments of debt |
( |
) | — | |||||
Borrowings of debt |
— | |||||||
Payment of debt financing fees |
( |
) | ( |
) | ||||
Net cash provided by financing activities |
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Net increase in cash |
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Cash, beginning of period |
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Cash, end of period |
$ | $ | ||||||
Supplemental disclosure of cash flow information: |
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Interest paid |
$ | $ | ||||||
1. |
Basis of presentation and summary of significant accounting policies |
2. |
Accounts receivable |
Total | ||||
Balance as of January 1, 2021 |
$ | |||
Charges to provision for credit losses |
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Write-off of uncollectible receivables |
( |
) | ||
Balance as of March 31, 2021 |
$ | |||
3. |
Inventory |
March 31, 2021 |
December 31, 2020 |
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Raw materials |
$ | $ | ||||||
Work in process |
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Finished products |
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Inventory |
$ | $ | ||||||
4. |
Prepaid and other current assets |
March 31, 2021 |
December 31, 2020 |
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Insurance |
$ | $ | ||||||
Paragraph IV legal proceeding costs |
— | |||||||
Other |
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Prepaid and other current assets |
$ | $ | ||||||
5. |
Fixed assets, net |
March 31, 2021 |
December 31, 2020 |
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Furniture and fixtures |
$ | $ | ||||||
Computer and office equipment |
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Computer software |
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Leasehold improvements |
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Fixed assets |
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Less: accumulated depreciation and amortization |
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Fixed assets, net |
$ | $ | ||||||
6. |
License rights and other intangible assets, net |
March 31, 2021 |
December 31, 2020 |
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Gross Carrying Amount |
Accumulated Amortization |
Net |
Gross Carrying Amount |
Accumulated Amortization |
Net |
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Intangible assets subject to amortization |
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License rights agreement |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
Hormone therapy drug patents |
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Hormone therapy drug patents applied and pending approval |
— | — | ||||||||||||||||||||||
Intangible assets not subject to amortization Trademarks/trade name rights |
— | — | ||||||||||||||||||||||
$ | $ | $ | $ | $ | $ | |||||||||||||||||||
7. |
Accrued expenses and other current liabilities |
March 31, 2021 |
December 31, 2020 |
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Payroll and related costs |
$ | $ | ||||||
Rebates |
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Sales returns and coupons |
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Wholesale distributor fees |
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Professional fees |
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Other accrued expenses and current liabilities |
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Accrued expenses and other current liabilities |
$ | $ | ||||||
8. |
Debt |
March 2021 |
December 31, 2020 |
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Financing Agreement |
$ | $ | ||||||
Less: deferred financing fees |
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Debt, net |
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Current maturities of long-term debt |
— | |||||||
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Long-term debt |
$ | $ | ||||||
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Three Months Ended March 31, |
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2021 | 2020 | |||||||
Interest expense |
$ | $ | ||||||
Interest prepayment fees |
— | |||||||
Financing fees amortization |
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Interest expense and other financing costs |
$ | $ | ||||||
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Year Ended December 31, |
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2021 (9 months) |
$ | |||
2022 |
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2023 |
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2024 |
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$ | ||||
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9. |
Commitments and contingencies |
10. |
Stockholders’ equity (deficit) |
11. |
Revenue |
Three Months Ended March 31, |
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2021 | 2020 | |||||||
ANNOVERA |
$ | $ | ||||||
IMVEXXY |
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BIJUVA |
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Prescription vitamin |
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Product revenue, net |
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License revenue |
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Total revenue, net |
$ | $ | ||||||
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12. |
Operating expenses |
Three Months Ended March 31, |
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2021 | 2020 | |||||||
Compensation and employee benefits |
$ |
$ |
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Selling and marketing |
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General and administrative |
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Research and development |
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Total operating expenses |
$ |
$ |
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13. |
Income taxes |
14. |
Loss per common share |
Three Months Ended March 31, |
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2021 |
2020 |
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Numerator: |
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Net loss |
$ |
( |
) |
$ |
( |
) | ||
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Denominator: |
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Weighted average common shares for |
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basic loss per common share |
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Effect of dilutive securities |
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Weighted average common shares for |
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diluted loss per common share |
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Loss per common share, basic and diluted |
$ |
( |
) |
$ |
( |
) | ||
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Three Months Ended March 31, |
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2021 |
2020 |
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Stock options |
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RSUs |
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PSUs |
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Warrants |
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15. |
Related parties |
16. |
Business concentrations |
Three Months Ended March 31, | ||||
2021 |
2020 | |||
Customer A |
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Customer B |
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Customer C |
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Customer D |
* |
* |
Less than |
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March 31, 2021 |
December 31, 2020 | ||
Customer A |
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Customer B |
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Customer C |
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Customer D |
* |
* |
Balance was less than |
Three Months Ended March 31, | ||||
2021 |
2020 | |||
Catalent |
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Vendor A |
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Vendor B |
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Vendor C |
* | |||
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* |
Less than |
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March 31, 2021 |
December 31, 2020 | ||
Vendor D |
* | |||
Vendor E |
* | |||
Vendor F |
* | |||
Vendor G |
* |
* |
Balance was less than |
Three Months Ended March 31, |
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2021 | 2020 | |||||||
ANNOVERA |
$ | 8,750 | $ | 2,273 | ||||
IMVEXXY |
7,012 | 6,392 | ||||||
BIJUVA |
2,445 | 1,112 | ||||||
Prescription vitamin |
1,425 | 2,474 | ||||||
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Product revenue, net |
19,632 | 12,251 | ||||||
License revenue |
234 | — | ||||||
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|
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Total revenue, net |
19,866 | 12,251 | ||||||
Cost of goods sold |
4,687 | 2,715 | ||||||
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Gross profit |
$ | 15,179 | $ | 9,536 | ||||
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Three Months Ended March 31, |
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2021 | 2020 | |||||||
Compensation and employee benefits |
$ | 19,891 | $ | 18,018 | ||||
Selling and marketing |
13,865 | 29,742 | ||||||
General and administrative |
8,651 | 9,429 | ||||||
Research and development |
2,050 | 3,269 | ||||||
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|
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Total operating expenses |
$ | 44,457 | $ | 60,458 | ||||
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Three Months Ended March 31, |
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2021 | 2020 | |||||||
Net cash used in operating activities |
$ | (38,380 | ) | $ | (39,111 | ) | ||
Net cash used in investing activities |
$ | (438 | ) | $ | (443 | ) | ||
Net cash provided by financing activities |
$ | 95,949 | $ | 48,822 |
Item 1. |
Legal Proceedings |
Item 1A. |
Risk Factors |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
Item 3. |
Defaults Upon Senior Securities |
Item 4. |
Mine Safety Disclosures |
Item 5. |
Other Information |
Item 6. |
Exhibits |
Exhibit No. |
Description | |
10.4 | ||
10.5 | ||
10.6 | Controlled Equity OfferingSM Sales Agreement, dated March 3, 2021, by and between TherapeuticsMD, Inc. and Cantor Fitzgerald & Co.(6) | |
31.1* | ||
31.2* | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) | |
32.1** | Section 1350 Certification of Chief Executive Officer | |
32.2** | Section 1350 Certification of Chief Executive Officer | |
101* | Inline XBRL Document Set for the condensed consolidated financial statements and accompanying notes in Part I, Item 1, “Financial Statements” of this Quarterly Report on Form 10-Q | |
104* | Inline XBRL for the cover page of this Quarterly Report on Form 10-Q, included in the Exhibit 101 Inline XBRL Document Set |
* | Filed herewith. |
** | Furnished herewith. |
(1) |
Filed as Exhibit 10.24 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 4, 2021 and incorporated herein by reference (SEC File No. 001-00100). |
(2) |
Filed as Exhibit 10.12 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 4, 2021 and incorporated herein by reference (SEC File No. 001-00100). |
(3) |
Filed as Exhibit 10.25 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 4, 2021 and incorporated herein by reference (SEC File No. 001-00100). |
(4) |
Filed as Exhibit 10.14 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 4, 2021 and incorporated herein by reference (SEC File No. 001-00100). |
(5) |
Filed as Exhibit 10.16 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 4, 2021 and incorporated herein by reference (SEC File No. 001-00100). |
(6) |
Filed as Exhibit 1.2 to the Company’s Registration Statement on Form S-3 filed with the Securities and Exchange Commission on March 4, 2021 and incorporated herein by reference (SEC File No. 333-253851). |
Date: May 6, 2021 | TherapeuticsMD, Inc. | |||
/s/ Robert G. Finizio | ||||
Robert G. Finizio Chief Executive Officer | ||||
/s/ James C. D’Arecca | ||||
James C. D’Arecca Chief Financial Officer |
Exhibit 31.1
Certification of Chief Executive Officer
I, Robert G. Finizio, certify that:
(1) | I have reviewed this quarterly report on Form 10-Q of TherapeuticsMD, Inc.; |
(2) | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
(3) | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
(4) | The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
(5) | The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: May 6, 2021
/s/ Robert G. Finizio |
Robert G. Finizio Chief Executive Officer |
Exhibit 31.2
Certification of Chief Financial Officer
I, James C. DArecca, certify that:
(1) | I have reviewed this quarterly report on Form 10-Q of TherapeuticsMD, Inc.; |
(2) | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
(3) | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
(4) | The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
(5) | The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: May 6, 2021
/s/ James C. DArecca |
James C. DArecca Chief Financial Officer |
Exhibit 32.1
Section 1350 Certification of Chief Executive Officer
In connection with the quarterly report of TherapeuticsMD, Inc. (the Company) on Form 10-Q for the quarterly period ended March 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Robert G. Finizio, Chief Executive Officer of the Company, certify, to my best knowledge and belief, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a) or 78o(d)); and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
Date: May 6, 2021
/s/ Robert G. Finizio |
Robert G. Finizio Chief Executive Officer |
The foregoing certification is being furnished as an exhibit to the Report pursuant to Item 601(b)(32) of Regulation S-K and Section 906 of the Sarbanes-Oxley Act of 2002 and, accordingly, is not being filed with the Securities and Exchange Commission as part of the Report and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Securities Exchange Act of 1934 (whether made before or after the date of the Report, irrespective of any general incorporation language contained in such filing).
Exhibit 32.2
Section 1350 Certification of Chief Financial Officer
In connection with the quarterly report of TherapeuticsMD, Inc. (the Company) on Form 10-Q for the quarterly period ended March 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, James C. DArecca, Chief Financial Officer of the Company, certify to my best knowledge and belief, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a) or 78o(d)); and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
Date: May 6, 2021
/s/ James C. DArecca |
James C. DArecca Chief Financial Officer |
The foregoing certification is being furnished as an exhibit to the Report pursuant to Item 601(b)(32) of Regulation S-K and Section 906 of the Sarbanes-Oxley Act of 2002 and, accordingly, is not being filed with the Securities and Exchange Commission as part of the Report and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Securities Exchange Act of 1934 (whether made before or after the date of the Report, irrespective of any general incorporation language contained in such filing).