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).
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end
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands |
Mar. 31, 2021 |
Dec. 31, 2020 |
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Statement of Financial Position [Abstract] | ||
Accounts Receivable, Allowance for Credit Loss | $ 1,231 | $ 1,118 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 600,000,000 | 600,000,000 |
Common Stock, Shares, Issued | 393,190,000 | 299,765,000 |
Common Stock, Shares, Outstanding | 393,190,000 | 299,765,000 |
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended | |
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Mar. 31, 2021 |
Mar. 31, 2020 |
|
Total revenue, net | $ 19,866 | $ 12,251 |
Cost of goods sold | 4,687 | 2,715 |
Gross profit | 15,179 | 9,536 |
Operating expenses: | ||
Selling, general and administrative | 42,407 | 57,189 |
Research and development | 2,050 | 3,269 |
Total operating expenses | 44,457 | 60,458 |
Loss from operations | (29,278) | (50,922) |
Other (expense) income: | ||
Interest expense and other financing costs | (10,227) | (6,262) |
Other income, net | 122 | 335 |
Other (expense), net | (10,105) | (5,927) |
Loss before income taxes | (39,383) | (56,849) |
Provision for income taxes | 0 | 0 |
Net loss | $ (39,383) | $ (56,849) |
Loss per share, basic and diluted: | ||
Loss per common share, basic and diluted | $ (0.11) | $ (0.21) |
Weighted average common shares, basic and diluted | 347,219 | 271,460 |
Product [Member] | ||
Total revenue, net | $ 19,632 | $ 12,251 |
License [Member] | ||
Total revenue, net | $ 234 |
Basis of presentation and summary of significant accounting policies |
3 Months Ended | ||
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Mar. 31, 2021 | |||
Accounting Policies [Abstract] | |||
Basis of presentation and summary of significant accounting policies |
General TherapeuticsMD, Inc., a Nevada corporation (the “Company”), and its consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q (“10-Q Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 10-Q Report includes our trademarks, trade names and service marks, such as TherapeuticsMD® , vitaMedMD® , BocaGreenMD® , IMVEXXY® , BIJUVA® and ANNOVERA® , which are protected under applicable intellectual property laws and are the property of, or licensed to, our company. Solely for convenience, trademarks, trade names and service marks referred to in this 10-Q Report may appear without the ® , TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties. We are a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products. We also have a portfolio of branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands. Our portfolio of products focused on women’s health allows us to efficiently leverage our sales and marketing plan to grow our recently approved products. Principles of consolidation We prepared the consolidated financial statements included in this 10-Q Report following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“U.S. GAAP”) can be condensed or omitted. Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in this 10-Q Report should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2020 Annual Report on Form 10-K (“2020 10-K Report”). Certain amounts in the consolidated financial statements and accompanying notes may not add due to rounding. All percentages have been calculated using unrounded amounts. Risks and uncertainties related to COVID-19 We continue to be subject to risks and uncertainties in connection with the COVID-19 pandemic. The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict. We continue to provide an uninterrupted supply of our portfolio of products for patients. We believe we have sufficient inventory of finished products to meet anticipated demand in the near future. Additionally, we believe we have sufficient active pharmaceutical ingredients on hand for the continued manufacture of our products. Since the early phase of the COVID-19 pandemic, we have been using substantial virtual options to ensure business continuity. One of our subsidiaries, vitaCare™ Prescription Services, Inc. (“vitaCare Prescription Services”), a Florida corporation, assists patients in obtaining easy and convenient access to their prescriptions for products at a pharmacy of their choice, including via home delivery pharmacy options. We have also partnered with independent community pharmacies and multiple third-party online pharmacies and telemedicine providers that focus on contraception or menopause which provide patients real-time access to both diagnosis and treatment. We continue to support prescribers’ needs with samples and product materials through our sales force. If access is restricted, we have mailing options in place for these materials. We also have business continuity plans and infrastructure in place that allows for live virtual e-detailing of our products. As part of our response to the COVID-19 pandemic, we implemented measures to reduce marketing expenses for 2020. We also implemented cost saving measures in 2020, which included negotiating lower fees or suspending services from third party vendors; implementing a company-wide hiring restriction; delaying or cancelling non-critical information technology projects; and eliminating non-essential travel, entertainment, meeting, and event expenses.The full impact of the COVID-19 pandemic continues to evolve. However, we remain committed to the execution of our corporate goals, despite the ongoing COVID-19 pandemic, as demonstrated in part by the increase in product revenue throughout 2020. As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain. We are continuing to assess the effect of the COVID-19 pandemic on our operations by monitoring the spread of COVID-19 and the various actions implemented to combat the pandemic throughout the world. Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future. While we currently believe that our COVID-19 contingency plan has the ability to mitigate the effect of the COVID-19 pandemic on our business, the severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic, the duration of “social distancing” orders, the ability of our sales force to access healthcare providers to promote our products, increases in unemployment, which could reduce access to commercial health insurance for our patients, thus limiting payer coverage for our products, and the impact of the pandemic on our global supply chain, all of which are uncertain. Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face. Significant accounting policies The significant accounting policies we use for quarterly financial reporting are disclosed in Note 2, Summary of Significant Accounting Policies of the accompanying notes to the consolidated financial statements included in our 2020 10-K Report, and in the section below. Accounting standards issued but not yet adopted There have been no recently issued accounting standards not yet adopted by us which are expected, upon adoption, to have a material impact on our consolidated financial statements or processes. Reclassification Certain amounts reported in prior periods in the financial statements have been reclassified to conform to the current period’s presentation. |
Accounts receivable |
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Receivables [Abstract] | |||||||||||||||||||||||||||||||||||||||||||
Accounts receivable |
We extend credit on an unsecured basis to most of our customers. Our exposure to credit losses may increase if our customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the current COVID-19 pandemic, or other customer-specific factors. While we actively manage our credit exposure and work to respond to both changes in our customers’ financial conditions or macroeconomic events, there can be no guarantee we will be able to mitigate all of these risks successfully. Although we have historically not experienced significant credit losses, it is possible that there could be a material adverse impact from potential adjustments of the carrying amount of trade receivables in the future.W e review accounts receivable for uncollectible accounts and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, reasonable supportable forecasts and existing economic conditions and we record an allowance that presents the net amount expected to be collected. We evaluate trade accounts receivable for delinquency. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required.The following sets forth activities in our allowance for credit losses (in thousands):
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Inventory |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory |
W e have optimized the level of our inventory on hand, and we believe we have sufficient finished products to meet anticipated demand in the near future and sufficient raw materials for the continued manufacture of our finished products. We rely on third parties to manufacture our finished products, and we have entered into long-term supply agreements for the manufacture of ANNOVERA, IMVEXXY, and BIJUVA, however, we do not have a long-term supply agreement for the manufacture of our prescription vitamins. Additionally, we do not have long-term contracts for the supply of the active pharmaceutical ingredients (“API”) used in ANNOVERA and BIJUVA. If any of our third party contract manufacturers or any suppliers of the API experiences any significant difficulties in its respective manufacturing processes, do not comply with the terms of an agreement between us, or do not devote sufficient time, energy, and care to providing our manufacturing needs, we could experience significant interruptions in the supply of our products, which may have a material adverse impact on our revenue, results of operations and financial position. Our inventory consisted of the following (in thousands):
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Prepaid and other current assets |
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Prepaid Expense and Other Assets, Current [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Prepaid and other current assets |
Our prepaid and other current assets consisted of the following (in thousands):
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Fixed assets, net |
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fixed assets, net |
Our fixed assets, net consisted of the following (in thousands):
For the three months ended March 31, 2021 and 2020, we recorded depreciation expense of $ 193 thousand and $ 199 thousand, respectively. |
License rights and other intangible assets, net |
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Goodwill and Intangible Assets Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
License rights and other intangible assets, net |
The following provides information about our license rights and other intangible assets, net (in thousands):
During the three months ended March 31, 2021 and 2020, we recorded $ 756 thousand and $ 746 thousand, respectively, in amortization expense related to an exclusive license agreement (the “Population Council License Agreement”) with Population Council to commercially manufacture and sell ANNOVERA in the U.S., which was recorded as a component of cost of sales. As of March 31, 2021 and December 31, 2020, respectively, we had a total of 79 patents, of which 40 were domestic, and a total of 77 patents, of which 38 were domestic. We recorded $ 70 thousand and $ 63 thousand of amortization expense related to patents for the three months ended March 31, 2021 and 2020, respectively. We use a combination of qualitative and quantitative factors to assess intangible assets for impairment. As a result of performing these assessments, we determined that no impairment existed as of March 31, 2021 and, therefore, recorded no write-downs to any of our intangible assets. |
Accrued expenses and other current liabilities |
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Payables and Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued expenses and other current liabilities |
Other accrued expenses and other current liabilities consisted of the following (in thousands):
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Debt |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt |
W e are party to a Financing Agreement, as amended (the “Financing Agreement”), with Sixth Street Specialty Lending, Inc., as administrative agent (the “Administrative Agent”), various lenders from time to time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors. Interest on amounts borrowed under the Financing Agreement is due and payable quarterly in arrears, and the Financing Agreement matures on March 31, 2024. In January 2021, we entered into Amendment No. 7 to the Financing Agreement (“Amendment No. 7”) pursuant to which, among other amendments, the minimum quarterly product net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA for the fiscal quarters ending March 31, 2021 and June 30, 2021 were reduced, and we paid an amendment financing fee of $5.0 million, which was included as a component of deferred financing fees in long-term debt in the accompany consolidated balance sheets. Additionally, in connection with entering into Amendment No. 7, the warrants issued to the Administrative Agent and the lenders under the Financing Agreement on August 5, 2020 were further amended to provide for an additional adjustment to the exercise price if we conducted certain dilutive issuances prior to March 31, 2021. No such adjustments were made to the exercise price of these warrants prior to the expiration of such period. I n March 2021, we entered into Amendment No. 8 to the Financing Agreement (“Amendment No. 8”) pursuant to which, among other amendments, the minimum quarterly product net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA were revised, the amortization and prepayment terms of the borrowings under the Financing Agreement were revised, and the Administrative Agent consented to a framework for our potential disposition of our vitaCare Prescription Services business. With respect to amortization and prepayment terms of the borrowings under the Financing Agreement, in connection with AmendmentNo. 8, we (i) repaid $ 50.0 million in principal under the Financing Agreement during the three months ended March 31 , 2021 , plus a 5.0% prepayment fee, and (ii) agreed to make additional principal repayments as follows: (x) $ 5.0 million on each of March 31 , 2022 , June 30 , 2022 and September 30 , 2022 ; (y) $ 10.0 million on each of December 31 , 2022 and March 31 , 2023 ; and (z) $ 41.25 million on each of June 30 , 2023 , September 30 , 2023 , December 31 , 2023 and March 31 , 2024 , plus the prepayment fees described in the following sentence. In connection with Amendment No . 8 , the prepayment fees on principal amounts being prepaid under the Financing Agreement were revised as follows: (i) 30.0% of the principal amount being repaid through March 31 , 2022 (excluding the scheduled $ 5.0 million principal repayment on such date, which is subject to a 5.0% prepayment fee); (ii) 5.0% of the principal amount being repaid from April 1 , 2022 through March 31 , 2023 ; (iii) 3.0% of the principal amount being repaid from April 1 , 2023 through March 31 , 2024 ; and (iv) thereafter, none , in each case subject to certain limited exceptions, including with respect to a repayment in full of the obligations under the Financing Agreement. Ou r debt consisted of the following (in thousands):
Interest and financing costs Interest expense and other financing costs consisted of the following (in thousands):
A mendment No. 7 and No. 8 were both accounted for as debt modification in accordance with U.S. GAAP. Accordingly, the unamortized deferred financing fees at each amendment date and the financing fee of $5.0 million for Amendment No. 7 are being deferred. These deferred financing fees are being amortized over the remining term of our Financing Agreement.
Debt covenants compliance The Financing Agreement requires us to have a minimum unrestricted cash balance of $ 60.0million. As of the filing date of this 10-Q Report, our cash balance was above the required minimum balance. Based on our current projections, along with financing that may be available to us under our at-the-market equity offering program relating to shares of our common stock, we anticipate that we will remain in compliance with the minimum cash balance covenant for the next twelve months from the issuance of the consolidated financial statements included in this 10-Q Report. In addition, we have reviewed numerous potential scenarios in connection with the impact of COVID-19 pandemic on our business and we believe that our existing cash reserves are sufficient to meet our cash needs arising in the ordinary course of business for the next twelve months from the issuance of the consolidated financial statements included in this 10-Q Report. However, if we are unsuccessful with the commercialization of IMVEXXY, BIJUVA, or ANNOVERA, if such commercialization is delayed, or if the continued impact of the COVID-19 pandemic on our business is worse than we anticipate, among other circumstances, we may consume funds significantly faster than we currently anticipate and our existing cash reserves would be insufficient to maintain compliance with the Financing Agreement covenants or satisfy our liquidity requirements until we are able to successfully commercialize IMVEXXY, BIJUVA, and ANNOVERA. T he Financing Agreement also requires us to maintain certain minimum quarterly product net revenue requirements and several other restrictive covenants. These and other terms in the Financing Agreement have to be monitored closely for compliance and could restrict our ability to grow our business or enter into transactions that we believe would be beneficial to our business. If we are unable to maintain the minimum unrestricted cash balance, achieve any of the total minimum net revenue requirements or otherwise comply with any other covenant of the Financing Agreement, all or a portion of our obligations under the Financing Agreement may be declared immediately due and payable, which would have an adverse effect on our business, results of operations and financial condition. |
Commitments and contingencies |
3 Months Ended | ||
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Mar. 31, 2021 | |||
Commitments and Contingencies Disclosure [Abstract] | |||
Commitments and contingencies |
Minimum purchase commitments We have manufacturing and supply agreements whereby we are required to purchase from Catalent, Inc. (“Catalent”) a minimum number of units of BIJUVA and IMVEXXY softgels during each respective annual contract year. The annual contract period for BIJUVA and IMVEXXY ends each April and July, respectively. If the minimum order quantities of BIJUVA or IMVEXXY are not met, we are required to pay a minimum commitment fee equal to 50% or 60 %, respectively, of the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of BIJUVA or IMVEXXY during each product’s respective contract year. Additionally, with another third-party manufacturer, we have a manufacturing and supply agreement whereby we are required to purchase a minimum number of units of ANNOVERA during a contract year. The annual contract period for ANNOVERA ends each August. If the minimum order quantities of ANNOVERA are not met, we are required to pay a minimum commitment fee equal to the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of ANNOVERA during the contract year. For each of the three annual contract years ending in 2021, we expect to meet our minimum purchase number of units in all material respects, accordingly, we believe that minimum commitment fees that we may pay, if any, will not have a material impact to our financial position and operating results. For annual contract years ending in 2022 and thereafter, we will continue to evaluate whether we will be able to meet each annual contract year’s respective minimum purchase commitment and will record a liability for estimated minimum commitment fees if we believe that we will not be able to reasonably meet the minimum purchase commitment. Legal Proceedings In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to FDA by Teva Pharmaceuticals USA, Inc. (“Teva”). The ANDA seeks approval from FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY. In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents listed in FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”), are invalid, unenforceable, and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product. The IMVEXXY Patents identified in the IMVEXXY Notice Letter expire in 2032 or 2033. In April 2020, we filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Teva’s ANDA would be a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents. Teva has filed its answer and counterclaim to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed. A trial date has not been set. In March 2020, we received a Paragraph IV certification notice letter (the “BIJUVA Notice Letter”) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals (“Amneal”). The ANDA seeks approval from FDA to commercially manufacture, use, or sell a generic version of BIJUVA. In the BIJUVA Notice Letter, Amneal alleges that TherapeuticsMD patents listed in FDA’s Orange Book that claim compositions and methods of BIJUVA (the “BIJUVA Patents”) are invalid, unenforceable, and/or will not be infringed by Amneal’s commercial manufacture, use, or sale of its proposed generic drug product. The BIJUVA Patents identified in the BIJUVA Notice Letter expire in 2032. In April 2020, we filed a complaint for patent infringement against Amneal in the United States District Court for the District of New Jersey arising from Amneal’s ANDA filing with FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Amneal’s ANDA would be a date no earlier than the expiration of the BIJUVA Patents and equitable relief enjoining Amneal from infringing the BIJUVA Patents. Amneal has filed its answer and counterclaim to the complaint, alleging that the BIJUVA Patents are invalid and not infringed. A trial date has not been set. In February 2021, the District Court entered an order temporarily staying all proceedings in the BIJUVA litigation. The District Court stay also extends the 30-month stay for the period in which the BIJUVA litigation has been stayed. As of March 31, 2021, in the aggregate, we have incurred and recorded paragraph IV legal proceeding costs amounting to $1.9 million in prepaid expenses and other current assets in the accompanying consolidated balance sheets since we believe that we will successfully prevail in these two legal proceedings. Upon the successful conclusion of each of the above legal proceeding, the related capitalized legal costs for that legal proceeding will be reclassified to patents, in license rights, and other intangible assets, net in the accompanying consolidated balance sheets and such costs will be amortized over the remaining useful of the respective patent. If we are unsuccessful in either one of the above legal proceedings, then the related capitalized legal costs and respective unamortized patent costs for that legal proceeding will be immediately expensed in the period in which we become aware of unsuccessful legal proceeding. |
Stockholders' equity (deficit) |
3 Months Ended | ||
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Mar. 31, 2021 | |||
Equity [Abstract] | |||
Stockholders' equity |
Common stock In November 2020, we entered into an at-the-market offering program (the “2020 ATM Program”) relating to shares of our common stock. The 2020 ATM Program permitted us to offer and sell shares of our common stock having an aggregate offering price of up to million from time to time through or to the sales agent under the 2020 ATM Program. Sales of our common stock were permitted to be made from time to time in at-the-market offerings as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”), including by means of ordinary broker’s transactions on the Nasdaq Stock Exchange or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with the sales agent. The sales agent was entitled to compensation at a fixed commission rate of of the aggregate gross sales price per share sold. As of February 8, 2021, sales of shares of our common stock under the 2020 ATM Program were completed when we sold an aggregate total of 28.6 million shares of our common stock at an average sale price of $1.75 per share, and we received net proceeds of $47.3 million, after deducting the underwriting discounts and commissions and estimated offering expenses. In February 2021, we closed on an underwritten public offering of our common stock, pursuant to which we issued an aggregate total of million shares of our common stock at an offering price of $1.85 per share, and we received net proceeds of $96.6 million, after deducting the underwriting discounts and commissions and estimated offering expenses. In March 2021, we entered into an at-the-market offering program (the “2021 ATM Program”) relating to shares of our common stock. The 2021 ATM Program permits us to offer and sell shares of our common stock having an aggregate offering price of up to million from time to time through or to the under the 2021 ATM Program sales agent. Sales of our common stock may be made from time to time in at-the-market offerings as defined in Rule 415 of the Securities Act, including by means of ordinary broker’s transactions on the Nasdaq Stock Exchange or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with the sales agent. The investment bank will be entitled to compensation at a fixed commission rate of of the aggregate gross sales price per share sold. The sales agent is not required to sell any specific number or dollar amounts of securities but will act as sales agent and use commercially reasonable efforts to sell on our behalf all of the shares of common stock requested to be sold by us, consistent with its normal trading and sales practices, on mutually agreed terms between us and the sales agent. Through March 31, 2021, we have sold 4.8 million shares of our common stock at an average sale price of per share and we received estimated net proceeds of $7.0 million, after deducting the underwriting discounts and commissions and estimated offering expenses. Subsequently, and through the date of this 10-Q Report filing, we have not sold any additional shares of our common stock under the 2021 ATM Program. Future sales, if any, under the 2021 ATM Program will depend on a variety of factors, including among others, market conditions, the trading price of our common stock, determinations by us of the appropriate sources of funding, and potential uses of funding available to us. Restricted stock units During the three months ended March 31, 2021, we granted 327 thousand restricted stock units (“RSUs”) at a weighted average grant date fair value of $1.58 per unit. The weighted average vesting life of these RSUs was 2.1 years. Additionally, we settled 52 thousand vested RSUs during the three months ended March 31, 2021 and the weighted average grant date fair value of these RSUs was $1.86 per unit. Furthermore, during the three months ended March 31, 2021, there were 732 thousand RSUs that vested, but were not yet settled as of March 31, 2021, and for which the weighted average grant date fair value was $1.07 per unit. We anticipate that settlement of these RSUs will occur in May 2021. Warrants In March 2021, a warrant holder exercised the holder’s right to purchase an aggregate of 205 thousand shares of our common stock for $50 thousand. Also, in March 2021, warrant holders exercised their rights to purchase an aggregate of 358 thousand shares of common stock pursuant to the warrant’s cashless exercise provision, wherein 298 thousand shares of our common stock were issued. In total, during the three months ended March 31, 2021, warrants to purchase an aggregate of 563 thousand shares of common stock were exercised and the weighted average exercise price of these warrants was $0.24 per share. |
Revenue |
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Disaggregation of Revenue [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue |
The following table provides information about disaggregated revenue by product mix and service (in thousands):
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Operating expenses |
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Operating Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Operating expenses |
The following provides information about operating expenses (in thousands):
Our compensation and employee benefits exclude those employees who perform research & development (“R&D”) related activities. Our R&D costs consist mainly of costs incurred under agreements with contract research organizations (“CROs”) and other third parties that conduct our clinical related studies, compensation and benefit costs related employees engaged in R&D activities, costs to developing our chemistry, manufacturing, and controls capabilities, costs related to manufacturing validation, and costs associated with other research activities and regulatory approvals. With regards to costs of clinical trials, they may vary significantly over the life of a project owing to a variety of factors and we base our expenses related to clinical trials on estimates based on our experience and estimates from CROs and other third parties. R&D expenditures for the drug products will continue after the clinical trial completes for on-going stability and laboratory testing, regulatory submission, and response work. |
Income taxes |
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Mar. 31, 2021 | |||
Income Tax Disclosure [Abstract] | |||
Income taxes |
We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the three months ended March 31, 2021 and 2020, (ii) additional losses expected for the remainder of 2021 or recorded in 2020, or (iii) net operating losses carry forwards from prior years. We recorded a full valuation allowance of the net operating losses for the three months ended March 31, 2021 and 2020. Accordingly, there were no provisions for income taxes for the three months ended March 31, 2021 and 2020. Additionally, as of March 31, 2021 and December 31, 2020, we maintain a full valuation allowance for all deferred tax assets. |
Loss per common share |
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Loss per common share |
The following table sets forth the computation of basic and diluted loss per common share for the periods presented (in thousands, except per share amounts):
S ince we reported a net loss for the three months ended March 31, 2021 and 2020, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per common share and our basic and diluted weighted average common share are the same for the three months ended March 31, 2021 and 2020. The following table sets forth the securities which are not included in the calculation of diluted earnings per common share (in thousands):
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Related parties |
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Mar. 31, 2021 | |||
Related Party Transactions [Abstract] | |||
Related Parties |
A member of our Board of Directors, J. Martin Carrol, is also a director of Catalent. From time to time, we have entered into agreements with Catalent and its affiliates in the normal course of business. Agreements with Catalent have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company. During the three months ended March 31, 2021 and 2020, we were billed by Catalent of $ 772 thousand and $ 1.3 million, respectively, for manufacturing activities. As of March 31, 2021 and December 31, 2020, we have estimated amounts payable to Catalent totaling $ 639 thousand and $ 276 thousand, respectively. In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 9, Commitments and contingencies. A member of our Board of Directors, Karen L. Ling, is an executive vice president and chief human resources officer of American International Group, Inc. (“AIG”). From time to time, we have entered into agreements with AIG in the normal course of business. Agreements with AIG have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company. During the three months ended March 31, 2021 and 2020, we were billed by AIG of $13 thousand and $71 thousand, respectively, for various insurance premiums. As of March 31, 2021 and December 31, 2020, we have no amounts payable to AIG. |
Business concentrations |
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Business concentrations |
We sell our products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. Customers with product revenue equal to or greater than 10% of our total revenue for the periods indicated were as follows:
Customers that accounted for 10% or greater of our accounts receivable as of the periods indicated were as follows:
We rely on third parties for the manufacture and supply of our products, as well as third-party logistics providers. In instances where these parties fail to perform their obligations, we may be unable to find alternatives suppliers or satisfactorily deliver our products to our customers on time, if at all. Vendors with product purchases equal to or greater than 10% of our total purchases for the periods indicated were as follows:
Vendors that accounted for 10% or greater of our accounts payable as of the periods indicated were as follows:
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Basis of presentation and summary of significant accounting policies (Policies) |
3 Months Ended |
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Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
General | General TherapeuticsMD, Inc., a Nevada corporation (the “Company”), and its consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q (“10-Q Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 10-Q Report includes our trademarks, trade names and service marks, such as TherapeuticsMD® , vitaMedMD® , BocaGreenMD® , IMVEXXY® , BIJUVA® and ANNOVERA® , which are protected under applicable intellectual property laws and are the property of, or licensed to, our company. Solely for convenience, trademarks, trade names and service marks referred to in this 10-Q Report may appear without the ® , TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties. We are a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products. We also have a portfolio of branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands. Our portfolio of products focused on women’s health allows us to efficiently leverage our sales and marketing plan to grow our recently approved products. |
Principles of consolidation | Principles of consolidation We prepared the consolidated financial statements included in this 10-Q Report following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“U.S. GAAP”) can be condensed or omitted. Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in this 10-Q Report should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2020 Annual Report on Form 10-K (“2020 10-K Report”). Certain amounts in the consolidated financial statements and accompanying notes may not add due to rounding. All percentages have been calculated using unrounded amounts. |
Risks and uncertainties related to COVID-19 | Risks and uncertainties related to COVID-19 We continue to be subject to risks and uncertainties in connection with the COVID-19 pandemic. The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict. We continue to provide an uninterrupted supply of our portfolio of products for patients. We believe we have sufficient inventory of finished products to meet anticipated demand in the near future. Additionally, we believe we have sufficient active pharmaceutical ingredients on hand for the continued manufacture of our products. Since the early phase of the COVID-19 pandemic, we have been using substantial virtual options to ensure business continuity. One of our subsidiaries, vitaCare™ Prescription Services, Inc. (“vitaCare Prescription Services”), a Florida corporation, assists patients in obtaining easy and convenient access to their prescriptions for products at a pharmacy of their choice, including via home delivery pharmacy options. We have also partnered with independent community pharmacies and multiple third-party online pharmacies and telemedicine providers that focus on contraception or menopause which provide patients real-time access to both diagnosis and treatment. We continue to support prescribers’ needs with samples and product materials through our sales force. If access is restricted, we have mailing options in place for these materials. We also have business continuity plans and infrastructure in place that allows for live virtual e-detailing of our products. As part of our response to the COVID-19 pandemic, we implemented measures to reduce marketing expenses for 2020. We also implemented cost saving measures in 2020, which included negotiating lower fees or suspending services from third party vendors; implementing a company-wide hiring restriction; delaying or cancelling non-critical information technology projects; and eliminating non-essential travel, entertainment, meeting, and event expenses.The full impact of the COVID-19 pandemic continues to evolve. However, we remain committed to the execution of our corporate goals, despite the ongoing COVID-19 pandemic, as demonstrated in part by the increase in product revenue throughout 2020. As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain. We are continuing to assess the effect of the COVID-19 pandemic on our operations by monitoring the spread of COVID-19 and the various actions implemented to combat the pandemic throughout the world. Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future. While we currently believe that our COVID-19 contingency plan has the ability to mitigate the effect of the COVID-19 pandemic on our business, the severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic, the duration of “social distancing” orders, the ability of our sales force to access healthcare providers to promote our products, increases in unemployment, which could reduce access to commercial health insurance for our patients, thus limiting payer coverage for our products, and the impact of the pandemic on our global supply chain, all of which are uncertain. Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face. |
Significant accounting policies | Significant accounting policies The significant accounting policies we use for quarterly financial reporting are disclosed in Note 2, Summary of Significant Accounting Policies of the accompanying notes to the consolidated financial statements included in our 2020 10-K Report, and in the section below. |
Accounting standards issued but not yet adopted | Accounting standards issued but not yet adopted There have been no recently issued accounting standards not yet adopted by us which are expected, upon adoption, to have a material impact on our consolidated financial statements or processes. |
Reclassification | Reclassification Certain amounts reported in prior periods in the financial statements have been reclassified to conform to the current period’s presentation. |
Accounts receivable (Tables) |
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||
Receivables [Abstract] | |||||||||||||||||||||||||||||||||||||||||
Summary of accounts receivable allowance for credit losses | The following sets forth activities in our allowance for credit losses (in thousands):
|
Inventory (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
inventory consisted of the following | W e have optimized the level of our inventory on hand, and we believe we have sufficient finished products to meet anticipated demand in the near future and sufficient raw materials for the continued manufacture of our finished products. We rely on third parties to manufacture our finished products, and we have entered into long-term supply agreements for the manufacture of ANNOVERA, IMVEXXY, and BIJUVA, however, we do not have a long-term supply agreement for the manufacture of our prescription vitamins. Additionally, we do not have long-term contracts for the supply of the active pharmaceutical ingredients (“API”) used in ANNOVERA and BIJUVA. If any of our third party contract manufacturers or any suppliers of the API experiences any significant difficulties in its respective manufacturing processes, do not comply with the terms of an agreement between us, or do not devote sufficient time, energy, and care to providing our manufacturing needs, we could experience significant interruptions in the supply of our products, which may have a material adverse impact on our revenue, results of operations and financial position. Our inventory consisted of the following (in thousands):
|
Prepaid and other current assets (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Prepaid Expense and Other Assets, Current [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
prepaid and other current assets consisted of the following | Our prepaid and other current assets consisted of the following (in thousands):
|
Fixed assets, net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Table Text Block] | Our fixed assets, net consisted of the following (in thousands):
|
License rights and other intangible assets, net (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The following provides information about our license rights and other intangible assets, net | The following provides information about our license rights and other intangible assets, net (in thousands):
|
Accrued expenses and other current liabilities (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule Of Other accrued expenses and other current liabilities | Other accrued expenses and other current liabilities consisted of the following (in thousands):
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Debt (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Out debt consisted of the following | Ou r debt consisted of the following (in thousands):
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Interest expense and other financing costs consisted of the following | Interest expense and other financing costs consisted of the following (in thousands):
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Future estimated amortization of our deferred financing fees | The future estimated amortization of our deferred financing fees is as follows (in thousands):
|
Revenue (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disaggregation of Revenue [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of information about disaggregated revenue by product mix | The following table provides information about disaggregated revenue by product mix and service (in thousands):
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Operating expenses (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Operating Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Information About Operating Expenses | The following provides information about operating expenses (in thousands):
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Loss per common share (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of computation of basic and diluted loss per common share | The following table sets forth the computation of basic and diluted loss per common share for the periods presented (in thousands, except per share amounts):
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Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | The following table sets forth the securities which are not included in the calculation of diluted earnings per common share (in thousands):
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Business Concentrations (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2021 | |||||||||||||||||||||||||||||||||||||||||
Disclosure of Revenue and Purchases [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Summary Of Customers With Product Revenue For The Periods Indicated Were As Follows | Customers with product revenue equal to or greater than 10% of our total revenue for the periods indicated were as follows:
|
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Summary Of Vendors With Product Purchases For The Periods | Vendors with product purchases equal to or greater than 10% of our total purchases for the periods indicated were as follows:
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Accounts Receivable [Member] | |||||||||||||||||||||||||||||||||||||||||
Disclosure of Revenue and Purchases [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Summary Of Customers With Product Revenue For The Periods Indicated Were As Follows | Customers that accounted for 10% or greater of our accounts receivable as of the periods indicated were as follows:
|
||||||||||||||||||||||||||||||||||||||||
Accounts Payable [Member] | |||||||||||||||||||||||||||||||||||||||||
Disclosure of Revenue and Purchases [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Summary Of Vendors With Product Purchases For The Periods | Vendors that accounted for 10% or greater of our accounts payable as of the periods indicated were as follows:
|
Accounts receivable - Summary Of Accounts Receivable Allowance For Credit Losses (Details) $ in Thousands |
3 Months Ended |
---|---|
Mar. 31, 2021
USD ($)
| |
Credit Loss [Abstract] | |
Beginning balance | $ 1,118 |
Charges to provision for credit losses | 230 |
Write-off of uncollectible receivables | (117) |
Ending Balance | $ 1,231 |
Inventory consisted of the following (Details) - USD ($) $ in Thousands |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Raw materials | $ 4,487 | $ 4,423 |
Work in process | 222 | 220 |
Finished products | 2,637 | 3,350 |
Inventory | $ 7,346 | $ 7,993 |
Prepaid and other current assets consisted of the following (Details) - USD ($) $ in Thousands |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|
Prepaid Expense and Other Assets, Current [Abstract] | ||
Insurance | $ 1,522 | $ 2,568 |
Paragraph IV legal proceeding costs | 1,926 | |
Other | 4,912 | 4,975 |
Prepaid and other current assets | $ 8,360 | $ 7,543 |
Fixed assets, net consisted of the following (Details) - USD ($) $ in Thousands |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|
Property, Plant and Equipment [Line Items] | ||
Fixed assets | $ 3,747 | $ 3,683 |
Less: accumulated depreciation and amortization | 1,935 | 1,741 |
Fixed assets, net | 1,812 | 1,942 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | 1,407 | 1,407 |
Computer and office equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | 1,810 | 1,784 |
Computer software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | 450 | 412 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets | $ 80 | $ 80 |
Fixed assets, net (Details Narrative) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 193 | $ 199 |
License rights and other intangible assets, net (Details Narrative) $ in Thousands |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2021
USD ($)
patents
|
Mar. 31, 2020
USD ($)
|
Dec. 31, 2020
patents
|
|
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | patents | 79 | 77 | |
Domestic US Patents | |||
Finite-Lived Intangible Assets [Line Items] | |||
Number of issued patents | patents | 40 | 38 | |
Licensing Agreements [Member] | Cost of Sales [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Amortization of intangible assets | $ | $ 756 | $ 746 | |
Patents [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Amortization of intangible assets | $ | $ 70 | $ 63 |
Accrued expenses and other current liabilities - Other accrued expenses and other current liabilities consisted of the following (Details) - USD ($) $ in Thousands |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|
Payables and Accruals [Abstract] | ||
Payroll and related costs | $ 8,311 | $ 11,179 |
Rebates | 12,691 | 11,011 |
Sales returns and coupons | 5,676 | 7,057 |
Wholesale distributor fees | 4,243 | 2,632 |
Professional fees | 6,198 | 925 |
Other accrued expenses and current liabilities | 8,855 | 5,366 |
Accrued expenses and other current liabilities | $ 45,974 | $ 38,170 |
Debt - Our debt consisted of the following (Details) - USD ($) $ in Thousands |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|
Debt Instrument [Line Items] | ||
Less: deferred financing fees | $ 16,030 | $ 12,302 |
Debt, net | 183,970 | 237,698 |
Current maturities of long-term debt | 5,000 | |
Long-term Debt | 178,970 | 237,698 |
Financing Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Financing Agreement | $ 200,000 | $ 250,000 |
Debt - Interest expense and other financing costs consisted of the following (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Interest Expense and Financing Costs of Debt [Line Items] | ||
Interest expense | $ 6,455 | $ 5,942 |
Interest prepayment fees | 2,500 | |
Financing fees amortization | 1,272 | 320 |
Interest expense and other financing costs | $ 10,227 | $ 6,262 |
Debt - Future estimated amortization of our deferred financing fees is as follows (Details) - USD ($) $ in Thousands |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | $ 16,030 | $ 12,302 |
2021 | ||
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | 4,377 | |
2022 | ||
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | 5,875 | |
2023 | ||
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | 5,078 | |
2024 | ||
Estimated Future Amortization Of Deferred Financing Fee Disclosure [Line Items] | ||
Deferred financing fees | $ 700 |
Commitments and Contingencies (Details Narrative) $ in Millions |
3 Months Ended |
---|---|
Mar. 31, 2021
USD ($)
| |
Prepaid Expenses and Other Current Assets [Member] | Paragraph Four Certification Notice Letter [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Legal proceeding costs | $ 1.9 |
BIJUVA [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Minimum supply commitment fee percentage payable | 50.00% |
IMVEXXY [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Minimum supply commitment fee percentage payable | 60.00% |
Operating Expenses (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Operating Expenses [Line Items] | ||
Research and development | $ 2,050 | $ 3,269 |
Total operating expenses | 44,457 | 60,458 |
Operating Expense [Member] | ||
Operating Expenses [Line Items] | ||
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 |
Total operating expenses | $ 44,457 | $ 60,458 |
Income Tax (Details Narrative) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Income Tax Disclosure [Abstract] | ||
Provision for income taxes | $ 0 | $ 0 |
Loss per common share - Summary of computation of basic and diluted loss per common share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
|
Numerator: | ||
Net loss | $ (39,383) | $ (56,849) |
Denominator: | ||
Weighted average common shares for basic loss per common share | 347,219 | 271,460 |
Effect of dilutive securities | 0 | 0 |
Weighted average common shares for diluted loss per common share | 347,219 | 271,460 |
Loss per common share, basic and diluted | $ (0.11) | $ (0.21) |
Related parties (Details) - USD ($) |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2021 |
Mar. 31, 2020 |
Dec. 31, 2020 |
|
Catalent [Member] | |||
Related Party Transaction [Line Items] | |||
Amount billed | $ 772,000 | $ 1,300,000 | |
Accounts Payable, Related Parties, Current | 639,000 | $ 276,000 | |
American International Group [Member] | |||
Related Party Transaction [Line Items] | |||
Amount billed | 13,000 | $ 71,000 | |
Accounts Payable, Related Parties, Current | $ 0 | $ 0 |
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