What changed in this filing

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Item 1. Financial Statements

2021-11-08 compared with 2021-08-06 · 104 added, 72 removed, 424 unchanged (29% of the section changed)

3 unchanged sentences

(in thousands, except share and per share amounts)

September 30,

Current assets:

24 unchanged sentences

Stockholders’ equity:

Common stock, $ 0.001 par value per share ( 175,000,000 shares authorized, 142,873,795 and 140,617,606 shares issued, 142,832,486 and 140,576,297 shares outstanding at June 30, 2021 and December 31, 2020, respectively)

Common stock, $ 0.001 par value per share ( 175,000,000 shares authorized, 142,984,448 and 140,617,606 shares issued, 142,943,139 and 140,576,297 shares outstanding at September 30, 2021 and December 31, 2020, respectively)

Additional paid-in capital

Treasury stock, at cost, 41,309 shares at June 30, 2021 and December 31, 2020

Treasury stock, at cost, 41,309 shares at September 30, 2021 and December 31, 2020

Accumulated deficit

7 unchanged sentences

Three months ended

Six months ended

Nine months ended

September 30,

Product revenue, net

26 unchanged sentences

Issuance of restricted stock

Warrants issued with debt financing

Forfeiture of restricted stock

Issuance of common stock in public offering (net of offering costs of $0.2 million)

Offering costs paid

Compensation in respect of restricted stock granted to employees, directors and consultants

Balance at March 31, 2021

( 1,071,225 )

Issuance of common stock in connection with exercise of options

Issuance of common stock in connection with conversion of notes payable

Issuance of restricted stock

Forfeiture of restricted stock

Issuance of common stock in public offering

Issuance of common stock in public offering (net of offering costs of $ 10.9 million)

Issuance of common stock in At-the-Market offerings (net of offering costs of $ 1.4 million)

1 unchanged sentence

Balance at June 30, 2021

( 1,149,722 )

Issuance of common stock in connection with exercise of options

Issuance of restricted stock

Forfeiture of restricted stock

Offering costs paid

Compensation in respect of restricted stock and options granted to employees, directors and consultants

Balance at September 30, 2021

( 1,235,359 )

*Amount less than one thousand dollars

The accompanying notes are an integral part of the condensed consolidated financial statements.

Treasury Stock

3 unchanged sentences

Forfeiture of restricted stock

Offering costs paid

Compensation in respect of restricted stock granted to employees, directors and consultants

Balance at March 31, 2020

( 1,071,225 )

Issuance of common stock in connection with exercise of options

1 unchanged sentence

Forfeiture of restricted stock

Issuance of common stock in public offering

Issuance of common stock in At-the-Market offerings (net of offering costs of $ 0.5 million)

Compensation in respect of restricted stock granted to employees, directors and consultants

Balance at June 30, 2020

( 1,149,722 )

*Amount less than one thousand dollars

The accompanying notes are an integral part of the condensed consolidated financial statements.

Issuance of common stock in connection with exercise of options

Issuance of restricted stock

Forfeiture of restricted stock

Issuance of common stock in offerings (net of offering costs of $ 10.9 million)

Issuance of common stock in At-the-Market offerings (net of offering costs of $ 2.0 million)

Compensation in respect of restricted stock granted to employees, directors and consultants

Balance at September 30, 2020

TG Therapeutics, Inc.

1 unchanged sentence

(in thousands)

Six months ended

Nine months ended

September 30,

CASH FLOWS FROM OPERATING ACTIVITIES

10 unchanged sentences

Increase in accounts receivable

Increase (decrease) in accounts payable and accrued expenses

Increase in accounts payable and accrued expenses

Decrease in lease liabilities

Decrease in other liabilities

Decrease in other current liabilities

Decrease in deferred revenue

3 unchanged sentences

Investment in held-to-maturity securities

Purchases of equipment

Purchases of PPE

Net cash (used in) provided by investing activities

21 unchanged sentences

TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases.

In addition to an active research pipeline including five investigational medicines across these therapeutic areas, UKONIQ received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapies.

Currently, we have three programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development.

In addition to an active research pipeline including five investigational medicines across these therapeutic areas, UKONIQ received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory FL who have received at least three prior lines of systemic therapies.

Currently, we have three programs in Phase 3 development for the treatment of patients with RMS and patients with CLL and several investigational medicines in Phase 1 clinical development.

We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.

6 unchanged sentences

The accompanying condensed December 31, 2020 balance sheet has been derived from these statements.

The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.

The results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.

In December 2018, the Company created an Australian corporation, TG Therapeutics AUS Pty Ltd.

6 unchanged sentences

We have incurred operating losses since our inception and expect to continue to incur operating losses for the foreseeable future and may never become profitable.

As of June 30, 2021, we have an accumulated deficit of $ 1.1 billion.

As of September 30, 2021, we have an accumulated deficit of $ 1.2 billion.

Our major sources of cash have been proceeds from private placements and public offerings of equity securities.

6 unchanged sentences

We may continue to incur substantial operating losses even as we begin to generate revenues from our drug candidates.

As of June 30, 2021, we had $ 456.2 million in cash and cash equivalents, and investment securities.

We anticipate that our cash and cash equivalents, and investment securities as of June 30, 2021 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Quarterly Report on Form 10-Q.

As of September 30, 2021, we had $ 381.4 million in cash and cash equivalents, and investment securities.

We anticipate that our cash and cash equivalents, and investment securities as of September 30, 2021 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Quarterly Report on Form 10-Q.

The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our UKONIQ commercialization efforts, preparations for the potential commercialization of our other drug candidates, and the timing, design and conduct of clinical trials for our drug candidates.

2 unchanged sentences

Summary of Significant Accounting Policies

Our significant accounting policies are described in Note 1 of Notes to Consolidated Financial Statements included in our 2020 Annual Report on Form 10-K, except as it relates to revenue recognition, accounts receivable, inventory, cost of product revenue, and the adoption of new accounting standards during the six months ended June 30, 2021, as discussed below.

Our significant accounting policies are described in Note 1 of Notes to Consolidated Financial Statements included in our 2020 Annual Report on Form 10-K, except as it relates to revenue recognition, accounts receivable, inventory, cost of product revenue, and the adoption of new accounting standards during the nine months ended September 30, 2021, as discussed below.

Revenue Recognition

6 unchanged sentences

The Company records product revenue reserves, which are classified as a reduction in product revenues, to account for the components of variable consideration.

Variable consideration includes the following components:

chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance, which are described below.

These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against to the Company's customer account) or a liability (if the amount is expected to be settled with a cash payment).

Variable consideration includes the following components, which are described below:

chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance.

These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against the Company's customer account) or a liability (if the amount is expected to be settled with a cash payment).

The Company's estimates of reserves established for variable consideration are calculated based upon a consistent application of the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts.

11 unchanged sentences

For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe a rebate under the Medicare Part D program.

GPO and Payor Rebates:

the Company contracts with various private payor organizations and group purchasing organizations (GPO), primarily insurance companies, pharmacy benefit managers and clinics, for the payment of rebates with respect to utilization of our product.

The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.

Trade Discounts and Allowances:

11 unchanged sentences

● product that the Company, at its sole discretion, has specified can be returned for credit.

As of June 30, 2021, the Company has not received any returns.

As of September 30, 2021, the Company has not received any returns.

Co-Payment Assistance Programs:

5 unchanged sentences

We analyze accounts that are past due for collectability, and regularly evaluate the creditworthiness of our customers so that we can properly assess and respond to changes in their credit profiles.

As of June 30, 2021, we determined an allowance for expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances.

As of September 30, 2021, we determined an allowance for

expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances.

Cost of Product Revenue

Cost of product revenue consists primarily of materials, third-party manufacturing costs, as well as freight and royalties owed to our licensing partner for UKONIQ sales.

Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, the manufacturing costs of UKONIQ units recognized as revenue during the three and six months ended June 30, 2021 were expensed prior to receipt of FDA approval on February 5, 2021, and therefore are not included in costs of product revenue during the current period.

Cost of product revenue consists primarily of materials and third-party manufacturing costs, as well as freight and royalties owed to our licensing partner for UKONIQ sales.

Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, the manufacturing costs of UKONIQ units recognized as revenue during the three and nine months ended September 30, 2021 were expensed prior to receipt of FDA approval on February 5, 2021, and therefore are not included in costs of product revenue during the current period.

Prior to regulatory approval, we expense costs relating to the production of inventory as research and development expense in the period incurred.

6 unchanged sentences

Diluted net loss per share of common stock is the same as basic net loss per share of common stock since potentially dilutive securities from stock options, stock warrants and convertible preferred stock would have an antidilutive effect either because we incurred a net loss during the period presented or because such potentially dilutive securities were out of the money and should the Company realize net income during the period presented.

The cumulative amounts of potentially dilutive securities excluded from the calculation were 13,255,355 securities and 10,535,748 securities for the six months ended June 30, 2021 and 2020, respectively.

The cumulative amounts of potentially dilutive securities excluded from the calculation were 13,126,038 securities and 11,103,701 securities for the nine months ended September 30, 2021 and 2020, respectively.

The following outstanding shares of potentially dilutive securities were excluded from the computation of net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive:

Six Months Ended

Nine Months Ended

September 30,

Unvested restricted stock

20 unchanged sentences

We record our best estimate of sales discounts and allowances to which customers are likely to be entitled.

The reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments was as follows for the three and six months ended June 30, 2021:

The reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments was as follows for the three and nine months ended September 30, 2021:

(in thousands)

Three months ended

Six months ended

June 30, 2021

Nine months ended

September 30, 2021

Gross product revenue

6 unchanged sentences

Net product revenue

(1) As of June 30, 2021 approximately $ 0.2 million of estimated gross-net-accruals have been recorded as a reduction of accounts receivable, net and within accounts payable and accrued expenses on the condensed consolidated balance sheets.

(1) As of September 30, 2021 approximately $ 0.4 million of estimated gross-net-accruals have been recorded as a reduction of accounts receivable, net and within accounts payable and accrued expenses on the condensed consolidated balance sheets.

NOTE 3 INVESTMENT SECURITIES

Our investments as of June 30, 2021 and December 31, 2020 are classified as held-to-maturity.

Our investments as of September 30, 2021 and December 31, 2020 are classified as held-to-maturity.

Held-to-maturity investments are recorded at amortized cost.

The following table summarize our investment securities at June 30, 2021 and December 31, 2020:

June 30, 2021

The following table summarize our investment securities at September 30, 2021 and December 31, 2020:

September 30, 2021

(in thousands)

2 unchanged sentences

Short-term investments:

Obligations of domestic governmental agencies (maturing between July 2021 and April 2022) (held-to-maturity)

Obligations of domestic governmental agencies (maturing between October 2021 and April 2022) (held-to-maturity)

Long-term investments:

14 unchanged sentences

● Level 3 unobservable inputs that are not corroborated by market data.

As of June 30, 2021 and December 31, 2020, the fair values of cash and cash equivalents, restricted cash, and notes and interest payable, approximate their carrying values.

The following tables provide the fair value measurements of applicable financial liabilities as of June 30, 2021 and December 31, 2020:

Financial liabilities at fair value as of June 30, 2021

As of September 30, 2021 and December 31, 2020, the fair values of cash and cash equivalents, restricted cash, and notes and interest payable, approximate their carrying values.

The following tables provide the fair value measurements of applicable financial liabilities as of September 30, 2021 and December 31, 2020:

Financial liabilities at fair value as of September 30, 2021

(in thousands)

3 unchanged sentences

Cash, cash equivalents, accounts payable and debt are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature.

The following table summarizes the changes in Level 3 instruments during the six months ended June 30, 2021:

The following table summarizes the changes in Level 3 instruments during the nine months ended September 30, 2021:

(in thousands)

2 unchanged sentences

Change in fair value of Level 3 liabilities

Balance at June 30, 2021

Balance at September 30, 2021

The change in the fair value of the Level 3 liabilities is reported in other (income) expense in the accompanying condensed consolidated statements of operations.

13 unchanged sentences

The 2021 ATM has replaced the 2020 ATM as the only active ATM program.

We had no activity on the 2021 ATM during the six months ended June 30, 2021.

We had no activity on the 2021 ATM during the nine months ended September 30, 2021.

The 2019 WKSI Shelf is currently our only active shelf-registration statement.

4 unchanged sentences

Amended and Restated 2012 Incentive Plan (the 2012 Incentive Plan) was approved by stockholders in June 2020.

As of June 30, 2021, 12,110,206 shares of restricted stock and 2,479,622 options were outstanding and up to an additional 1,845,268 shares may be issued under the 2012 Incentive Plan.

Stock-based compensation expense included in the condensed consolidated statements of operations was $ 16.3 million and $ 7.4 million for the three months ended June 30, 2021 and 2020, respectively, and $ 32.9 million and $ 18.4 million for the six months ended June 30, 2021 and 2020, respectively.

The following table summarizes the activity for stock options and restricted stock for the six months ended June 30, 2021:

As of September 30, 2021, 11,992,744 shares of restricted stock and 2,467,537 options were outstanding and up to an additional 1,746,700 shares may be issued under the 2012 Incentive Plan.

Stock-based compensation expense included in the condensed consolidated statements of operations was $ 14.0 million and $ 28.3 million for the three months ended September 30, 2021 and 2020, respectively, and $ 46.9 million and $ 46.8 million for the nine months ended September 30, 2021 and 2020, respectively.

The following table summarizes the activity for stock options and restricted stock for the nine months ended September 30, 2021:

(in thousands)

3 unchanged sentences

Changes during the year:

Exercised/ vested

Exercised or vested

Expired or Forfeited

Equity awards outstanding, end of period

As of June 30, 2021, total compensation cost related to unvested awards not yet recognized and the weighted-average periods over which the awards are expected to be recognized were as follows:

As of September 30, 2021, total compensation cost related to unvested awards not yet recognized and the weighted-average periods over which the awards are expected to be recognized were as follows:

(in thousands)

21 unchanged sentences

In addition, a final payment equal to 3.5 % of the aggregate principal amount of the loan extended by Hercules is due on the maturity date.

As of June 30, 2021, we have paid approximately $ 7.2 million of the principal loan balance due to Hercules.

The Term Loan repayment schedule continues with monthly principal payments ranging from approximately $ 2.4 to $ 2.7 million per month through March 1, 2022.

As of September 30, 2021, we have paid approximately $ 14.6 million of the principal loan balance due to Hercules.

The Term Loan repayment schedule continues with monthly principal payments ranging from approximately $ 2.5 million to $ 2.7 million per month through March 1, 2022.

The Term Loan is secured by a lien on substantially all of our assets, other than intellectual property, and contains customary covenants and representations.

As of June 30, 2021 and through the filing date of this report, the Company has been in compliance with all covenants.

As of September 30, 2021 and through the filing date of this report, the Company has been in compliance with all covenants.

The Loan Agreement contains several events of default, which we are in compliance with all terms.

14 unchanged sentences

The debt issuance costs are being amortized over the term of the debt using the straight-line method, which approximates the effective interest method, and are included in interest expense in the Company’s unaudited condensed consolidated statements of operations.

Amortization of debt issuance costs was $ 0.2 million for each of the three months ended June 30, 2021 and 2020, respectively, and $ 0.5 million for each of the six months ended June 30, 2021 and 2020, respectively.

At June 30, 2021, the remaining unamortized balance of debt issuance costs was $ 0.6 million.

The loan payable as of June 30, 2021 and December 31, 2020 is as follows:

Amortization of debt issuance costs was $ 0.3 million and $ 0.2 million for each of the three months ended September 30, 2021 and 2020, respectively, and $ 0.7 million for each of the nine months ended September 30, 2021 and 2020, respectively.

At September 30, 2021, the remaining unamortized balance of debt issuance costs was $ 0.4 million.

The loan payable as of September 30, 2021 and December 31, 2020 is as follows:

September 30,

(in thousands)

12 unchanged sentences

At January 1, 2019, we recognized a lease liability and corresponding Right-of-Use (ROU) asset of $ 9.5 million and $ 8.1 million, respectively, based on the present value of the remaining lease payments for all of our leased office spaces, the majority of which is comprised of our New York City office space.

The present values of our lease liability and corresponding ROU asset are $ 11.7 million and $ 9.0 million, respectively, as of June 30, 2021.

The present values of our lease liability and corresponding ROU asset are $ 11.5 million and $ 8.8 million, respectively, as of September 30, 2021.

Our leases have remaining lease terms of 2 years to 10 years .

2 unchanged sentences

We and FBIO currently determine actual office space utilization annually and if our utilization differs from the amount we have been billed, we will either receive credits or be assessed incremental utilization charges.

As of June 30, 2021, the allocation rate is 65 % and will be evaluated again in August 2021 for the following rent year.

As of September 30, 2021, the allocation rate is 65 % and will be evaluated again in November 2021 for the following rent year.

Also in connection with this lease, we have pledged $ 1.2 million to secure a line of credit as a security deposit for the Office Agreement, which has been recorded as restricted cash in the accompanying condensed consolidated balance sheets.

2 unchanged sentences

We took possession of this space in October 2019, with rental payments beginning in November 2019.

We incurred rent expense of $ 0.1 million for the six months ended June 30, 2021.

The following components of lease expense are included in the Company’s condensed consolidated statements of operations for the three and six months ended June 30, 2021 and 2020:

We incurred rent expense of $ 0.2 million for the nine months ended September 30, 2021.

The following components of lease expense are included in the Company’s condensed consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020:

Three months ended

Six months ended

Nine months ended

September 30,

(in thousands)

1 unchanged sentence

Net lease cost

As of June 30, 2021, the weighted-average remaining operating lease term was 7.5 years and the weighted-average discount rate for operating leases was 10.25 %.

Cash paid for amounts included in the measurement of operating lease liabilities during the six months ended June 30, 2021 was $ 1.0 million.

As of September 30, 2021, the weighted-average remaining operating lease term was 7.4 years and the weighted-average discount rate for operating leases was 10.25 %.

Cash paid for amounts included in the measurement of operating lease liabilities during the nine months ended September 30, 2021 was $ 1.5 million.

The balance sheet classification of lease liabilities was as follows:

September 30,

(in thousands)

2 unchanged sentences

Total lease liability

As of June 30, 2021, the maturities of lease liabilities were as follows:

As of September 30, 2021, the maturities of lease liabilities were as follows:

(in thousands)

10 unchanged sentences

An upfront payment of $ 2.0 million, which was received in December 2012, net of $ 0.3 million of income tax withholdings, is being recognized as license revenue on a straight-line basis over the life of the agreement, which is through the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated, and represents the estimated period over which we will have certain ongoing responsibilities under the sublicense agreement.

We recorded license revenue of approximately $ 38,000 for each of the three months ended June 30, 2021 and 2020, and approximately $ 76,000 for each of the six months ended June 30, 2021 and 2020, and at June 30, 2021 and December 31, 2020, have deferred revenue of approximately $ 0.7 million and $ 0.8 million, respectively, associated with this $ 2 million payment (approximately $ 0.2 million of which has been classified in current liabilities at June 30, 2021 and December 31, 2020).

We recorded license revenue of approximately $ 38,000 for each of the three months ended September 30, 2021 and 2020, and approximately $ 114,000 for each of the nine months ended September 30, 2021 and 2020, and at September 30, 2021 and December 31, 2020, have deferred revenue of approximately $ 0.6 million and $ 0.8 million, respectively, associated with this $ 2.0 million payment (approximately $ 0.2 million of which has been classified in current liabilities at September 30, 2021 and December 31, 2020).

We may receive up to an additional $ 5.0 million in payments upon the achievement of pre-specified milestones.

2 unchanged sentences

Under the license agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab.

As of June 30, 2021 we have incurred approximately $ 7.0 million and accrued approximately $ 3.0 million related to milestones.

As of September 30, 2021 we have incurred and paid approximately $ 10.0 million related to milestones.

LFB Group is eligible to receive payments of up to an aggregate of approximately $ 31.0 million upon our successful achievement of certain clinical development, regulatory, and sales milestones, in addition to royalty payments on net sales of ublituximab at a royalty rate that escalates from mid-single digits to high-single digits.

3 unchanged sentences

Prior to this, we had been jointly developing umbralisib in a 50:50 joint venture with Rhizen.

During the six months ended June 30, 2021, we paid Rhizen $ 12.0 million as part of a primary indication approval milestone for launch of product in the US in accordance with the terms of the Umbralisib License.

During the nine months ended September 30, 2021, we paid Rhizen $ 12.0 million as part of a primary indication approval milestone for launch of product in the US in accordance with the terms of the Umbralisib License.

Rhizen will be eligible to receive additional approval and sales-based milestone payments in the aggregate of approximately $ 175 million payable upon approval in multiple jurisdictions for up to two oncology indications and one non-oncology indication and attaining certain sales milestones.

1 unchanged sentence

Additionally, Rhizen receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib and any New Product.

During the three and six months ended June 30, 2021, the Company recorded $ 0.1 million and $ 0.2 million, respectively, related to the worldwide royalty due under the Umbralisib License in cost of product revenue based on U.S.

sales of UKONIQ and as of June 30, 2021, $ 0.1 million in royalties were payable under the Umbralisib License.

During the three and nine months ended September 30, 2021, the Company recorded $ 0.1 million and $ 0.3 million, respectively, related to the worldwide royalty due under the Umbralisib License in cost of product revenue based on U.S.

sales of UKONIQ and as of September 30, 2021, $ 0.1 million in royalties were payable under the Umbralisib License.

Rhizen will also be eligible to participate in sublicensing revenue, if any, based on a percentage that decreases as a function of the number of patients treated in clinical trials following the exercise of the license option.

4 unchanged sentences

(Checkpoint) for the development and commercialization of anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies.

The Collaboration Agreement was amended in June 2019 and in March of 2020 we achieved the first milestone event for which we incurred expenses of zero for each of the three months ended June 30, 2021 and 2020, respectively, and zero and approximately $ 0.9 million for the six months ended June 30, 2021 and 2020, respectively.

The Collaboration Agreement was amended in June 2019 and in March of 2020 we achieved the first milestone event for which we incurred expenses of zero for each of the three months ended September 30, 2021 and 2020, and zero and approximately $ 0.9 million for the nine months ended September 30, 2021 and 2020, respectively.

In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui Medicine Co.

6 unchanged sentences

Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses.

We incurred expenses of approximately $ 4.1 million and $ 0.9 million for the three months ended June 30, 2021 and 2020, respectively, and $ 4.9 million and $ 1.8 million for the six months ended June 30, 2021 and 2020, respectively, the majority of which relates to manufacturing expenses of BTK.

We incurred expenses of approximately $ 4.2 million and $ 0.3 million for the three months ended September 30, 2021 and 2020, respectively, and $ 9.0 million and $ 0.6 million for the nine months ended September 30, 2021 and 2020, respectively, the majority of which relates to manufacturing expenses of BTK.

The relevant expenses are recorded in other research and development in the accompanying unaudited condensed consolidated statement of operations.

4 unchanged sentences

Pursuant to the agreement, in June 2018 we paid Novimmune an upfront payment of $ 3.0 million in our common stock recorded to noncash stock expense associated with in-licensing agreements in our consolidated statement of operations.

As of June 30, 2021, we have incurred approximately $ 2.0 million in milestone expense related to patient enrollment.

As of September 30, 2021, we have incurred approximately $ 2.0 million in milestone expense related to patient enrollment.

Further milestone payments will be paid based on early clinical development, and the Company will be responsible for the costs of clinical development of the product through the end of the Phase 2 clinical trials, after which the Company and Novimmune will be jointly responsible for all development and commercialization costs.

3 unchanged sentences

This Shared Services Agreement requires us to pay our respective share of services utilized.

In connection with the Shared Services Agreement, we incurred expenses of approximately $ 0.2 million for each of the three months ended June 30, 2021 and 2020, and expenses of approximately $ 0.4 million for each of the six months ended June 30, 2021 and 2020, primarily related to shared personnel.

In connection with the Shared Services Agreement, we incurred expenses of approximately $ 0.2 million for each of the three months ended September 30, 2021 and 2020, and expenses of approximately $ 0.6 million for each of the nine months ended September 30, 2021 and 2020, primarily related to shared personnel.

Please refer to Note 7 - Leases for details regarding the Office Agreement with FBIO, as well as Note 8 - License Agreements for details regarding the Collaboration Agreement with Checkpoint.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements