41 unchanged sentences
AND SUBSIDIARIES
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: Three Months Ended March 31,
+Added: CONDENSED CONSOLIDATED
+Added: STATEMENTS OF OPERATIONS
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Cost of product revenue
18 unchanged sentences
AND SUBSIDIARIES
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
−Removed: STOCKHOLDERS’
−Removed: EQUITY (Unaudited)
−Removed: For the Three Months Ended March 31, 2023
+Added: CONDENSED CONSOLIDATED
+Added: STATEMENTS OF CHANGES IN
+Added: STOCKHOLDERS’ EQUITY (Unaudited)
+Added: For the Three and Six Months Ended June 30, 2023
Stockholders’
6 unchanged sentences
( 484,805,486
−Removed: For the Three Months Ended March 31, 2022
+Added: Stock-based compensation
+Added: Vesting of Restricted Stock Units, net of shares withheld for taxes
+Added: Warrants issued in connection with note payable
+Added: Cashless exercise of warrants
+Added: Exercise of stock options
+Added: Balance at June 30, 2023
+Added: ( 491,176,193
+Added: For the Three and Six Months Ended June 30, 2022
Stockholders’
6 unchanged sentences
( 437,120,578
+Added: Stock-based compensation
+Added: Vesting of Restricted Stock Units, net of shares withheld for taxes and retired
+Added: Balance at June 30, 2022
+Added: ( 450,885,484
The accompanying notes are an integral part of these condensed consolidated financial statements.
2 unchanged sentences
CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: Three Months Ended March 31,
+Added: Six Months Ended June 30,
CASH FLOWS FROM OPERATING ACTIVITIES:
25 unchanged sentences
Payments on finance lease obligations
+Added: Proceeds from the exercise of stock options
Payment of deferred financing fees
24 unchanged sentences
collection business with ten plasma collection facilities
−Removed: located throughout the U.S., eight of which hold an approved license with the FDA.
+Added: located throughout the U.S., nine of which hold an approved license with the FDA.
The Company has three FDA-approved products, all of which are currently marketed and commercially available:
−Removed: (i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”) product indicated for the
−Removed: treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity, and for which the Company received FDA approval on May 9, 2019 and commenced commercial sales in
−Removed: (ii) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI, for which the Company received FDA approval on April 1, 2019 and commenced first commercial sales in October
−Removed: and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen (“HBsAg”) and other listed exposures to Hepatitis B.
−Removed: In addition to its
−Removed: commercially available immunoglobulin products, the Company provides contract manufacturing and laboratory services for certain clients and generates revenues from the sale of intermediate by-products that result from the immunoglobulin
−Removed: production process.
−Removed: The Company seeks to develop a pipeline of plasma-derived therapeutics, and its products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at
−Removed: risk for certain infectious diseases.
−Removed: As of March 31, 2023, the Company had working capital of $ 227.4 million, including $ 69.2 million of cash and cash
−Removed: Based upon the Company’s current projected revenue and expenditures, including capital expenditures and continued implementation of the Company’s commercialization and expansion activities, the Company’s management currently
−Removed: believes that its cash, cash equivalents, projected revenue and accounts receivable will be sufficient to fund ADMA’s operations, as currently conducted, through the end of the second quarter of 2024, by which time the Company believes it
−Removed: will have begun generating positive cash flow from operations.
−Removed: These estimates may change based upon several factors, including the success of the Company’s commercial efforts with respect to the sale of its products, whether or not the
−Removed: assumptions underlying the Company’s projected revenues and expenses are correct and the acceptability of ADMA’s immune globulin products by physicians, patients or payers.
−Removed: There can be no assurance that the Company’s approved products will
−Removed: be commercially viable, or that plant capacity expansion or other capital improvements will be successfully completed or that any product developed in the future will be approved.
−Removed: The Company is subject to risks common to companies in the
−Removed: biologics, biotechnology and pharmaceutical manufacturing industries including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key
−Removed: personnel, inflationary pressures, supply chain constraints, protection of proprietary technology and compliance with FDA and other governmental regulations and approval requirements.
−Removed: Company continues to evaluate a variety of strategic alternatives through its ongoing engagement with Morgan Stanley.
−Removed: The exploration of value-creating opportunities remains a top corporate priority for ADMA.
+Added: (i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”)
+Added: product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity, and for which the Company received FDA approval on May 9, 2019 and commenced
+Added: commercial sales in August 2019;
+Added: (ii) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI, for which the Company received FDA approval on April 1, 2019 and commenced first
+Added: commercial sales in October 2019;
+Added: and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen (“HBsAg”) and other listed exposures to Hepatitis
+Added: In addition to its commercially available immunoglobulin products, the Company provides contract manufacturing and laboratory services for certain clients and generates revenues from the sale of intermediate by-products that result from
+Added: the immunoglobulin production process.
+Added: The Company seeks to develop a pipeline of plasma-derived therapeutics, and its products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised
+Added: patients with or at risk for certain infectious diseases.
+Added: As of June 30, 2023, the Company had working capital of $ 224.3 million, including $ 62.5 million of cash
+Added: and cash equivalents.
+Added: Based upon the Company’s current projected revenue and expenditures, including capital expenditures and continued implementation of the Company’s commercialization and expansion activities, the Company’s management
+Added: currently believes that its cash, cash equivalents, projected revenue and accounts receivable will be sufficient to fund ADMA’s operations, as currently conducted, through the end of the third quarter of 2024, by which time the Company
+Added: believes it will have been generating positive cash flow from operations.
+Added: These estimates may change based upon several factors, including the success of the Company’s commercial efforts with respect to the sale of its products, whether or
+Added: not the assumptions underlying the Company’s projected revenues and expenses are correct and the continued acceptability of ADMA’s immune globulin products by physicians, patients or payers.
+Added: There can be no assurance that the Company’s
+Added: approved products will be commercially viable, or that plant capacity expansion or other capital improvements will be successfully completed or that any product developed in the future will be approved.
+Added: The Company is subject to risks common
+Added: to companies in the biologics, biotechnology and pharmaceutical manufacturing industries including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations,
+Added: dependence on key personnel, inflationary pressures, supply chain constraints, protection of proprietary technology and compliance with FDA and other governmental regulations and approval requirements.
+Added: continues to evaluate a variety of strategic alternatives.
+Added: While the exploration of value-creating opportunities remains a top corporate priority for the Company, ADMA has terminated its financial advisory agreement with Morgan Stanley.
ADMA BIOLOGICS, INC.
19 unchanged sentences
In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and
−Removed: assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2023 and its results of operations, changes in stockholders’ equity and cash flows for the three months
−Removed: ended March 31, 2023 and 2022.
−Removed: During the three months ended March 31, 2023 and 2022, comprehensive loss was equal to the net loss amounts
−Removed: presented for the respective periods in the accompanying condensed consolidated statements of operations.
−Removed: Operating results for interim periods are not necessarily indicative of the results that may be expected for the full fiscal year.
+Added: assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position as of June 30, 2023, its results of operations and changes in stockholders’ equity for the three and six months ended
+Added: June 30, 2023 and its cash flows for the six months ended June 30, 2023 and 2022.
+Added: During the three and six months ended June 30, 2023 and 2022, comprehensive loss was equal to the net loss
+Added: amounts presented for the respective periods in the accompanying condensed consolidated statements of operations.
+Added: Operating results for interim periods are not necessarily indicative of the results that may be expected for the full fiscal
Use of Estimates
11 unchanged sentences
Accounts receivable is reported at realizable value, net of allowances for contractual credits and doubtful accounts in
−Removed: the amount of $ 0.1 million at March 31 , 2023 and December 31, 2022, respectively, which are recognized in the period the related revenue is recorded.
−Removed: Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history.
−Removed: Evaluations of the financial condition, payment history and associated credit risk of customers are performed on an
−Removed: ongoing basis.
+Added: the amount of $ 0.2 million and $ 0.1
+Added: million at June 30 , 2023 and December 31, 2022, respectively, which
+Added: are recognized in the period the related revenue is recorded.
+Added: The Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history.
+Added: Evaluations of
+Added: the financial condition, payment history and associated credit risk of customers are performed on an ongoing basis.
Based on these evaluations, the Company has concluded that its credit risk is minimal.
−Removed: At March 31 , 2023, five customers accounted for an aggregate of 98 % of the Company’s total accounts receivable, and at December 31, 2022, two customers accounted for approximately 92 % of the Company’s total
−Removed: accounts receivable.
+Added: At June 30 , 2023, three customers accounted for an aggregate of 94 % of the Company’s total
+Added: accounts receivable, and at December 31, 2022, two customers accounted for approximately 92 % of the Company’s total accounts receivable.
ADMA BIOLOGICS, INC.
19 unchanged sentences
Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company.
−Removed: at March 31 , 2023 and December 31, 2022 was $ 3.5 million.
+Added: June 30 , 2023 and December 31, 2022 was $ 3.5 million.
All of the Company’s goodwill is attributable to its ADMA BioManufacturing business segment and is related to the Biotest
7 unchanged sentences
The Company’s annual
−Removed: goodwill impairment test as of October 1, 2022 did not result in a goodwill impairment charge, and the Company did no t record any impairment charges related to goodwill for the three months
−Removed: ended March 31 , 2023 and 2022.
+Added: goodwill impairment test as of October 1, 2022 did not result in a goodwill impairment charge, and the Company did no t record any impairment charges related to goodwill for the three and six
+Added: months ended June 30 , 2023 and 2022.
Impairment of Long-Lived Assets
4 unchanged sentences
Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results.
−Removed: three months ended March 31 , 2023 and 2022, the Company
+Added: three and six months ended June 30 , 2023 and 2022, the Company
determined that there was no impairment of its long-lived assets.
3 unchanged sentences
Revenue Recognition
−Removed: Revenues for the three months ended March 31 , 2023
+Added: Revenues for the three and six months ended June 30 , 2023
and 2022 are comprised of (i) revenues from the sale of the Company’s immunoglobulin products, BIVIGAM, ASCENIV and Nabi-HB, (ii) product revenues from the sale of human plasma collected through the
19 unchanged sentences
Product revenues are recognized at the time of delivery if the Company retains control of the product during shipment.
−Removed: For the three months ended March 31 , 2023 , three customers represented an aggregate of 76 % of the Company’s consolidated revenues.
−Removed: For the three months ended March 31 , 2022, three customers represented an aggregate
−Removed: of 83 % of the Company’s consolidated revenues.
+Added: For the six months ended June 30 , 2023 , two customers represented an aggregate of 68 % of the Company’s consolidated revenues.
+Added: For the six months ended June 30 , 2022, two customers represented an aggregate of
+Added: 73 % of the Company’s consolidated revenues.
Cost of Product Revenue
13 unchanged sentences
a net loss for all periods presented.
−Removed: For the three months ended March 31 , 2023 and 2022, the
+Added: For the six months ended June 30 , 2023 and 2022, the
following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive effects:
−Removed: For the Three Months Ended March 31,
+Added: For the Six Months Ended June 30,
Stock options
24 unchanged sentences
Based on its analysis, the Company
−Removed: has determined that it has no t incurred any liability for unrecognized tax benefits as of March 31, 2023 and December 31,
−Removed: 2022, and during the three months ended March 31, 2023 and 2022, the Company recognized no
+Added: has determined that it has no t incurred any liability for unrecognized tax benefits as of June 30, 2023 and December 31,
+Added: 2022, and during the six months ended June 30, 2023 and 2022 the Company recognized no
adjustments for uncertain tax positions.
6 unchanged sentences
These materials will be consumed in the production of goods expected to be available for sale or otherwise have alternative uses that provide a probable future benefit.
−Removed: All other activities and materials associated with the production of
−Removed: inventories used in research and development activities are expensed as incurred.
Work-in-process inventory primarily consists of bulk drug substance and unlabeled filled vials of the Company’s
6 unchanged sentences
INTANGIBLE ASSETS
−Removed: Intangible assets at March 31, 2023 and December 31, 2022 consist of the following:
−Removed: March 31, 2023
+Added: Intangible assets at June 30, 2023 and December 31, 2022 consist of the following:
+Added: June 30, 2023
December 31, 2022
1 unchanged sentence
Rights to intermediates
−Removed: All of the Company’s intangible assets were acquired in the Biotest Transaction.
−Removed: Amortization expense
−Removed: related to these intangible assets was $ 0.2 million for the three months ended March 31, 2023 and 2022.
−Removed: Estimated future
−Removed: aggregate amortization expense is expected to be as follows:
+Added: All of the Company’s intangible assets were acquired in the
+Added: Biotest Transaction.
+Added: Amortization expense related to these intangible assets was $ 0.2 million for the three months ended June 30,
+Added: 2023 and 2022, and $ 0.4 million for the six months ended June 30, 2023 and 2022.
+Added: Estimated future aggregate amortization expense is expected to be as follows:
Remainder of 2023
1 unchanged sentence
Property and equipment and related accumulated depreciation are summarized as
−Removed: March 31, 2023
+Added: June 30, 2023
December 31, 2022
15 unchanged sentences
The Company recorded depreciation expense on property and equipment for the three
−Removed: months ended March 31, 2023 and 2022 of $ 1.9 million and $ 1.4 million, respectively.
−Removed: ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
−Removed: Accrued expenses and other current liabilities at March 31, 2023 and December 31, 2022 are as follows:
+Added: months ended June 30, 2023 and 2022 of $ 1.9 million and $ 1.5
+Added: million , respectively , and for the six months ended June 30, 2023 and 2022 of $ 3.8 million and $ 3.0 million, respectively .
ADMA BIOLOGICS, INC.
1 unchanged sentence
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: March 31, 2023
+Added: ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
+Added: Accrued expenses and other current liabilities at June 30, 2023 and December 31, 2022 are as follows:
+Added: June 30, 2023
December 31, 2022
6 unchanged sentences
A summary of outstanding senior notes payable is as follows:
−Removed: March 31, 2023
+Added: June 30, 2023
December 31, 2022
24 unchanged sentences
redemption premium paid to Perceptive.
−Removed: Borrowings under the Hayfin Credit Agreement bear interest, at the Company’s election, at either (a) a base rate (equal to the highest of (i) the rate of interest per annum
−Removed: last quoted by The Wall Street Journal as the “Prime Rate” in the United States, (ii) the federal funds rate in effect on such day plus 0.50 %
−Removed: and (iii) adjusted Term Secured Overnight Financing Rate (“SOFR”) for a one-month tenor in effect on such day plus 1.00 %), plus an applicable margin of 8.5 %,
−Removed: or (b) adjusted Term SOFR for either a one-month or three-month tenor, as elected by the Company, and subject to a floor of 1.25 %,
−Removed: plus an applicable margin of 9.5 % (the “Applicable Margin”);
−Removed: provided, however, that upon, and during the continuance of, an
−Removed: Event of Default, the Applicable Margin increases by an additional 3 % per annum.
−Removed: On the last day of each calendar month or
−Removed: quarter during the term of the Hayfin Credit Facility, the Company will pay accrued interest to Hayfin.
−Removed: The rate of interest in effect as of March 31,2023 and December 31, 2022 was 14.4 % and 13.9 %, respectively.
−Removed: The Company is also
−Removed: permitted to pay “in kind” a portion of the interest on the Hayfin Loans for each monthly or quarterly interest period in an amount equal to 2.5 %
+Added: From the time of the Hayfin Closing Date through May 1, 2023, borrowings under the Hayfin Credit Agreement bore interest, at the Company’s election, at either (a) a base rate
+Added: (equal to the highest of (i) the rate of interest per annum last quoted by The Wall Street Journal as the “Prime Rate” in the United States, (ii) the federal funds rate in effect on such day plus 0.50 % and (iii) adjusted Term Secured Overnight Financing Rate (“SOFR”) for a one-month tenor in effect on such day plus 1.00 %), plus an applicable margin of 8.5 %, or (b) adjusted Term SOFR for either a one-month
+Added: or three-month tenor, as elected by the Company, and subject to a floor of 1.25 %, plus an applicable margin of 9.5 % (the
+Added: “Applicable Margin”);
+Added: provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin increases by an additional 3 % per annum.
+Added: On the last day of each calendar month or quarter during the term of the Hayfin Credit Facility, the Company pays accrued interest to Hayfin.
+Added: The rate of interest in effect as of June 30,2023
+Added: and December 31, 2022 was 13.7 % and 13.9 %, respectively.
+Added: The Company is also permitted to pay “in kind” a portion of the interest on the Hayfin Loans for each monthly or quarterly interest period in an amount equal to
2.5 % per annum, which is added to the principal amount of the outstanding debt under the Hayfin Credit Facility.
−Removed: For the three months ending March 31,2023, approximately $ 1.0 million of interest was paid in kind and added to the balance of the outstanding Hayfin Loans.
+Added: For the six months ending June
+Added: 30,2023, approximately $ 2.0 million of interest was paid in kind and added to the balance of the outstanding Hayfin Loans.
ADMA BIOLOGICS, INC.
4 unchanged sentences
This exit fee is recorded separately as a
−Removed: non-current liability on the accompanying consolidated balance sheets as of March 31,2023 and December 31,2022.
+Added: non-current liability on the accompanying consolidated balance sheets as of June 30,2023 and December 31,2022.
Prior to the Hayfin Maturity Date, there are no scheduled principal payments on the Hayfin Loans.
−Removed: The Company may prepay outstanding principal on the Hayfin Loans at any time and from time to time upon five business days’ prior written notice, subject to the payment to Hayfin of, (A) any accrued but unpaid interest on the prepaid principal amount plus (B) an early
−Removed: prepayment fee in the amount equal to (i) 7.0 % of the prepaid principal amount, if prepaid on or prior to the first anniversary
−Removed: of the Hayfin Closing Date, (ii) 3.0 % of the prepaid principal amount, if prepaid after the first anniversary of the Hayfin
−Removed: Closing Date and on or prior to the second anniversary of the Hayfin Closing Date, or (iii) 1.0 % of the prepaid principal
−Removed: amount, if prepaid after the second anniversary of the Hayfin Closing Date and on or prior to the third anniversary of the Hayfin Closing Date.
−Removed: In addition, for any prepayments of principal or payment of principal on the Hayfin Maturity
−Removed: Date, the Company is also required to pay the exit fee.
All of the Company’s obligations under the Hayfin Credit Agreement are secured by a first-priority lien and security interest in substantially all of the Company’s tangible
17 unchanged sentences
30, 2022 to $ 250.0 million for the fiscal quarter ended December 31, 2026.
−Removed: As of March 31, 2023, the Company was in compliance
+Added: As of June 30, 2023, the Company was in compliance
with all of the covenants contained in the Hayfin Credit Agreement.
4 unchanged sentences
The Hayfin Warrants were valued by the Company at approximately $ 9.6 million as of the Hayfin Closing Date and have an expiration date of March 23, 2029 .
+Added: 1, 2023, the Company entered into a second amendment to the Hayfin Credit Agreement (the “Hayfin Second Amendment”) whereby the Applicable Margin for adjusted Term SOFR Loans was reduced from 9.5 % to 8.5 %.
+Added: The Hayfin Second Amendment also
+Added: extended the obligation of the lenders to make the Hayfin Delayed Draw Loan from June 30, 2023 to December 31, 2023.
+Added: the terms of the Hayfin Second Amendment, in the event the Company elects to prepay all or any portion of the outstanding principal on the Hayfin Loans, the Company will be subject to an early prepayment fee in the amount equal to (i) 7.0 % of the prepaid principal amount, if prepaid on or prior to the first anniversary of the Hayfin Second Amendment, (ii) 3.0 % of the prepaid principal amount, if prepaid after the first anniversary of the Hayfin Second Amendment and on or prior to the second
+Added: anniversary of the Hayfin Second Amendment, or (iii) 1.0 % of the prepaid principal amount, if prepaid after the second
+Added: anniversary of the Hayfin Second Amendment and on or prior to the third anniversary of the Hayfin Second Amendment.
+Added: For any prepayments of principal or payment of principal on the Hayfin Maturity Date, the Company is also required to
+Added: pay the exit fee.
+Added: In addition, the Hayfin Second Amendment provides for a 50 % reduction to the foregoing early prepayment
+Added: fees if the Hayfin Loans are prepaid in connection with a change in control of the Company or other strategic transactions as further described in the Hayfin Second Amendment.
+Added: In connection with the Hayfin Second Amendment, the Company issued additional warrants to the lenders to purchase 2,391,244
+Added: shares of the Company’s common stock at an exercise price of $ 3.2619 per share (the “ Hayfin Second Amendment Warrants”).
+Added: Second Amendment Warrants were valued at approximately $ 5.6 million and have an expiration date of May 1, 2030.
As a result of the upfront fee and exit fee paid or payable to Hayfin, the expenses incurred by the Company in connection with this transaction and the value of the Hayfin
−Removed: Warrants, the Company recognized an aggregate discount on the Hayfin Loans in the amount of $ 13.9 million.
−Removed: The Company records
−Removed: debt discount as a reduction to the face amount of the debt, and the debt discount is amortized as interest expense over the life of the debt using the interest method.
−Removed: Based on the fair value of the Hayfin Warrants and the aggregate amount
−Removed: of fees and expenses associated with obtaining the Hayfin Credit Facility, the effective interest rate on the Hayfin Loans as of March 31,2023 and December 31, 2022 was approximately 16.6 % and 16.1 %, respectively.
−Removed: See Note 14 for discussion of an additional amendment to the Hayfin Credit Facility.
+Added: Warrants and Hayfin Second Amendment Warrants, the Company recognized an aggregate discount on the Hayfin Loans in the amount of $ 19.5
+Added: The Company records debt discount as a reduction to the face amount of the debt, and the debt discount is amortized as interest expense over the life of the debt using the interest method.
+Added: Based on the fair value of the Hayfin
+Added: Warrants and the aggregate amount of fees and expenses associated with obtaining the Hayfin Credit Facility, the effective interest rate on the Hayfin Loans as of June 30,2023 and December 31, 2022 was approximately 17.4 % and 16.1 %, respectively.
ADMA BIOLOGICS, INC.
4 unchanged sentences
The Company is currently authorized to issue up to 10 million shares of preferred stock, $ 0.0001 , par value per share.
−Removed: There were no shares of preferred stock outstanding at March 31, 2023 and December 31, 2022.
−Removed: As of March 31, 2023 and December 31, 2022, the Company was authorized to issue 300,000,000 shares of its common stock, $ 0.0001
−Removed: par value per share, and 222,262,588 and 221,816,930 shares of common stock were outstanding as of March 31, 2023 and December 31, 2022, respectively.
−Removed: After giving effect to the 48,356,592 shares reserved for outstanding warrants and awards issued or reserved for future issuance under the Company’s equity incentive plans, as of March 31, 2023
−Removed: there were 29,380,820 shares of common stock available for issuance.
−Removed: In connection with the Hayfin Credit Agreement that the Company entered into on March 23, 2022 (see Note 7), the
−Removed: Company issued the Hayfin Warrants to purchase 9,103,047 shares of the Company’s common stock.
−Removed: The Hayfin Warrants were valued at
−Removed: $ 9.6 million using the Black-Scholes option-pricing model assuming an expected term of seven years , a volatility of 68.1 %, a dividend yield of 0 % and a risk-free rate of interest of 2.36 %.
−Removed: At March 31, 2023 and December 31,2022, the Company had outstanding warrants to purchase an aggregate of 13,525,148 shares of
−Removed: common stock, with a weighted-average exercise price of $ 1.99 per share with expiration dates ranging between May 2023 and
−Removed: December 2030 (see Note 14).
+Added: There were no shares of preferred stock outstanding at June 30, 2023 and December 31, 2022.
+Added: As of June 30, 2023 and December 31, 2022, the Company was authorized to issue 300,000,000 shares of its common stock, $ 0.0001 par
+Added: value per share, and 224,526,748 and 221,816,930
+Added: shares of common stock were outstanding as of June 30, 2023 and December 31, 2022, respectively.
+Added: After giving effect to the 46,940,501
+Added: shares reserved for outstanding warrants and awards issued or reserved for future issuance under the Company’s equity incentive plans, as of June 30, 2023 there were 28,532,751 shares of common stock available for issuance.
+Added: In connection with the Hayfin Credit Agreement that the Company entered into on March 23, 2022 (see Note 7), the Company
+Added: issued the Hayfin Warrants to purchase 9,103,047 shares of the Company’s common stock.
+Added: The Hayfin Warrants were valued at $ 9.6 million using the Black-Scholes option-pricing model assuming an expected term of seven years , a volatility of 68.1 %, a dividend yield of 0 % and a risk-free rate of interest of 2.36 %.
+Added: On May 1, 2023 the Company issued the Hayfin Second Amendment Warrants, which were valued at $ 5.6
+Added: million using the Black-Scholes option-pricing model assuming an expected term of seven years , a volatility of 67.8 %, a dividend yield of 0 %
+Added: and a risk-free rate of interest of 3.62 %.
+Added: On May 13, 2023, warrants to purchase 24,800 shares of
+Added: the Company’s common stock held by a former noteholder of the Company expired in accordance with their terms.
+Added: On June 16, 2023, various entities affiliated with Hayfin exercised 3,388,686 Hayfin Warrants in a cashless exercise transaction resulting in the Company issuing 1,967,847 shares of its common stock to such entities.
+Added: At June 30, 2023 and December 31, 2022, the Company had outstanding warrants to purchase an aggregate of 12,502,906 and 13,525,148 shares,
+Added: respectively, of common stock, with weighted-average exercise prices of $ 2.32 and $ 1.99 per share, respectively, with expiration dates ranging between December 2024 and December 2030.
Equity Incentive Plans
−Removed: The fair value of stock options granted under the Company’s equity incentive plans was determined on the
−Removed: date of grant using the Black-Scholes option valuation model.
−Removed: The Black-Scholes model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable.
−Removed: option valuation models require the input of certain subjective assumptions including the expected stock price volatility.
−Removed: The stock options granted to employees and directors have characteristics significantly different from those of
−Removed: traded options, and changes in the subjective input assumptions can materially affect the fair value estimate.
−Removed: The following assumptions were used to determine the fair value of options granted during the three months ended March 31, 2023 and 2022:
−Removed: Three Months Ended March 31,
+Added: The fair value of stock options granted under t he Company’s equity incentive plans w as determined on the date of grant using the Black-Scholes option valuation model.
+Added: The Black-Scholes model was
+Added: developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable.
+Added: In addition, option valuation models require the input of certain subjective assumptions including the
+Added: expected stock price volatility.
+Added: The stock options granted to employees and directors have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair
+Added: value estimate.
+Added: The following assumptions were used to determine the fair value of options granted during the six months ended June 30, 2023 and 2022:
+Added: ADMA BIOLOGICS, INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Six Months Ended June 30,
Expected term
3 unchanged sentences
Risk-free interest rate
−Removed: On June 21, 2022, the
−Removed: Company’s stockholders approved the ADMA Biologics, Inc.
−Removed: 2022 Compensation Plan (the “2022 Equity Plan”), which replaced the ADMA Biologics, Inc.
+Added: On June 21, 2022, the Company’s stockholders approved the ADMA Biologics, Inc.
+Added: 2022 Compensation Plan (the “2022 Equity
+Added: Plan”), which replaced the ADMA Biologics, Inc.
2014 Omnibus Incentive Compensation Plan.
−Removed: Approval of the 2022 Equity Plan resulted in
−Removed: approximately 18 million additional shares of the Company’s common stock being reserved for future awards.
−Removed: three months ended March 31, 2023 and 2022, the Company granted options to purchase an aggregate of 1,727,510 and 1,194,032 shares of common stock, respectively, to its directors and employees.
−Removed: The weighted average remaining contractual life of stock options
−Removed: outstanding and expected to vest at March 31, 2023 is 6.6 years.
−Removed: The weighted average remaining contractual life of stock
−Removed: options exercisable at March 31, 2023 is 5.3 years.
−Removed: the three months ended March 31, 2023, options to purchase 5,416 shares of common stock were exercised in a cashless transaction
−Removed: resulting in the issuance of 2,443 shares of common stock.
+Added: Approval of the 2022 Equity Plan resulted in approximately 18 million additional shares of the Company’s common stock being reserved for future awards.
+Added: During the six months ended June 30, 2023 and 2022, the
+Added: Company granted options to purchase an aggregate of 1,727,510 and 1,194,032 shares of common stock, respectively, to its directors and employees.
+Added: The weighted average remaining contractual life of stock options outstanding and expected to vest at June
+Added: 30, 2023 is 6.2 years.
+Added: The weighted average remaining contractual life of stock options exercisable at June 30, 2023 is 5.0 years.
+Added: During the six months ended June 30, 2023, options to purchase 178,829 shares of common stock were exercised and the Company received aggregate exercise proceeds of $ 0.5 million.
+Added: Also during the six months ended June 30, 2023, options to purchase 5,416
+Added: shares of common stock were exercised in a cashless transaction resulting in the issuance of 2,443 shares of common stock.
A summary of the Company’s option activity under the Company’s equity incentive plans and related information is as
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Exercise Price
Options outstanding, vested and expected to vest at December 31, 2022
−Removed: Options outstanding, vested and expected to vest at March 31, 2023
+Added: Options outstanding, vested and expected to vest at June 30, 2023
Options exercisable
−Removed: As of March 31, 2023, the Company had $ 5.6 million of unrecognized compensation expense related to options granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average
−Removed: period of 3.0 years.
−Removed: During the three months ended March 31, 2023 and 2022, the Company granted RSUs representing an aggregate
−Removed: of 2,666,260 and 1,059,266
−Removed: shares, respectively, to certain employees of the Company and to members of its Board of Directors .
+Added: As of June 30, 2023, the Company had $ 4.9 million of unrecognized compensation expense related to options granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period
+Added: of 2.9 years.
+Added: During the six months ended June 30, 2023 and 2022, the Company granted RSUs representing an aggregate of 2,976,260 and 1,109,266 shares,
+Added: respectively, to certain employees of the Company and to members of its Board of Directors.
These RSUs generally vest annually over a period of four years for employees and semi-annually over a period of one year for directors.
−Removed: During the three months ended March 31, 2023 , an aggregate of 628,283
−Removed: shares of common stock vested in connection with grants of RSUs.
−Removed: With respect to these vested RSUs, 185,068 shares valued at
−Removed: approximately $ 0.6 million were withheld by the Company to cover employees’ tax liabilities.
−Removed: These shares were no longer
−Removed: outstanding as of March
−Removed: summary of the Company’s unvested RSU activity and related information is as follows:
+Added: During the six months ended
+Added: June 30, 2023, an aggregate of 806,781 shares of common stock vested in connection with grants of RSUs.
+Added: With respect to these
+Added: vested RSUs, 246,082 shares valued at approximately $ 0.9 million were withheld by the Company to cover employees’ tax liabilities.
+Added: These shares were no longer outstanding as of June 30, 2023.
+Added: A summary of the
+Added: Company’s unvested RSU activity and related information is as follows:
+Added: ADMA BIOLOGICS, INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Average Grant
1 unchanged sentence
Balance at December 31, 2022
−Removed: Balance at March 31, 2023
−Removed: As of March 31, 2023 , the Company had $ 12.0 million of unrecognized compensation expense related to unvested RSUs granted under the Company’s equity incentive plans, which is expected to be recognized over a
−Removed: weighted-average period of 3.4 years.
+Added: Balance at June 30, 2023
+Added: As of June 30, 2023, the Company had $ 11.6 million of unrecognized compensation expense related to unvested RSUs granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average
+Added: period of 3.2 years.
Total stock-based compensation expense for all awards granted under the Company’s equity incentive plans for the three
−Removed: months ended March 31, 2023 and 2022 is as follows:
−Removed: Three Months Ended March 31,
+Added: and six months ended June 30, 2023 and 2022 is as follows:
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
Research and development
7 unchanged sentences
effective as of January 1, 2016, as amended from time to time , and pays monthly rent on this facility in the amount of $ 10,000 through December 31, 2026 .
−Removed: Rent expense for the three months ended March 31, 2023 and 2022 amounted to $ 30,000 (see Note 12).
−Removed: Areth is a company controlled by Dr.
+Added: Rent expense for the three and six months ended June 30, 2023 and 2022 amounted to $ 30,000 and $ 60,000 , respectively .
+Added: company controlled by Dr.
Grossman, the Vice Chairman of the Company’s Board of Directors, and Adam S.
−Removed: Grossman, the Company’s President and Chief Executive
−Removed: The Company also reimburses Areth for office and building-related (common area) expenses, equipment and certain other operational expenses, which were not material to the condensed consolidated financial statements for the three months
−Removed: ended March 31, 2023 and 2022.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: During the three months ended March 31, 2023 and 2022, the Company purchased certain specialized medical equipment and
−Removed: services primarily related to the Company’s plasma collection centers, as well as personal protective equipment, from GenesisBPS and its affiliates (“Genesis”), aggregating to $ 0.1 million and $ 43,000 , respectively.
+Added: Grossman, the Company’s President and Chief Executive Officer.
+Added: The Company also reimburses Areth for office and building-related
+Added: (common area) expenses, equipment and certain other operational expenses, which were not material to the condensed consolidated financial statements for the six months ended June 30, 2023 and 2022.
+Added: During the six months ended June 30, 2023 and 2022, the Company purchased certain specialized medical equipment and
+Added: services primarily related to the Company’s plasma collection centers, as well as personal protective equipment, from GenesisBPS and its affiliates (“Genesis”), aggregating to $ 0.2 million and $ 0.1 million, respectively.
Genesis is owned by Dr.
−Removed: Grossman and Adam Grossman.
+Added: and Adam Grossman.
See Note 7 for a discussion of the Company’s former credit facility and related
−Removed: transactions with Perceptive, a holder of more than 5 % of the Company’s common stock during the three months ended March 31, 2022.
+Added: transactions with Perceptive, a holder of more than 5 % of the Company’s common stock during the six months ended June 30, 2022.
There were no transactions with Perceptive
−Removed: during the three months ended March 31, 2023.
+Added: during the six months ended June 30, 2023.
COMMITMENTS AND CONTINGENCIES
3 unchanged sentences
Management does not expect that the outcome of any such claims or actions will have a material effect on the Company’s liquidity, results of operations or financial condition.
+Added: ADMA BIOLOGICS, INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: IT Systems Disruption
+Added: On June 19, 2023, the Company experienced an IT systems disruption, which rendered certain of the Company’s IT
+Added: technology systems inaccessible for less than one week.
+Added: The Company’s investigation of the disruption remains ongoing with the
+Added: assistance of third-party consultants.
+Added: As no definitive root cause has been identified, the Company believes, theoretically, this IT systems disruption may have been caused by a third-party who may have gained access to the system.
+Added: no original financial systems or other data loss or any evidence of files exfiltrated due to this disruption.
+Added: Normal course operations have resumed across the Company’s business units.
+Added: At the time of the disruption, the Company was in
+Added: production of two batches of BIVIGAM, and after a prolonged hold time, it was deemed to be a prudent GMP quality decision to
+Added: discard these two in-process production batches as these batches were no longer viable for further production or had any
+Added: alternative use.
+Added: As a result, the Company recorded a one-time, non-recurring charge of $ 2.1 million for this inventory, which is
+Added: reflected in Cost of product revenue in the accompanying consolidated statements of operations.
+Added: In addition, the Company believes that its Plasma center operating expenses were adversely impacted by approximately $ 0.7 million due to the temporary closing of the Company’s plasma collection centers while their IT systems were restored.
+Added: The Company carries appropriate insurance for these types of instances, and while there can be no assurances
+Added: ADMA will be reimbursed for the insurance claims made pertaining to these charges, the Company is actively working with its insurance broker and carriers.
COVID-19 Pandemic
14 unchanged sentences
or review of pending applications or submissions.
−Removed: Although the Company has received FDA approvals for five of its plasma collection centers since January 1, 2022 and received several other FDA approvals while two FDA inspections of the Boca Facility were completed during the year ended December 31, 2021, no assurances can be provided as to the timing for completion of any
−Removed: future regulatory submissions or applications that may be impacted by restrictions related to COVID-19.
−Removed: During the three months ended March 31, 2023 and 2022, revenue attributable to international customers was
−Removed: approximately 7 % and 6 %,
−Removed: respectively, of the Company’s total revenues.
−Removed: As the Company seeks to grow this aspect of its business, it may also be subject to the impacts of the COVID-19 pandemic in locations outside the United States.
+Added: Although the Company has received FDA approvals for six of its plasma collection centers since January 1, 2022 and received several other FDA approvals while two FDA inspections of the Boca Facility were completed during the year ended December 31, 2021, no assurances can be provided as to the timing for completion of any future regulatory
+Added: submissions or applications that may be impacted by restrictions related to COVID-19.
+Added: During the six months ended June 30, 2023 and 2022, revenue attributable to international customers was
+Added: approximately 7 % of the Company’s total revenues.
+Added: As the Company seeks to grow this aspect of its business, it may also be
+Added: subject to the impacts of the COVID-19 pandemic in locations outside the United States.
+Added: Notwithstanding the foregoing, the COVID-19 pandemic to date has not had a material impact on the Company’s financial
+Added: condition or results of operations, and the Company does not believe that its production operations at the Boca Facility, the Company’s contract fill/finishers or its plasma collection facilities have been significantly impacted by the
+Added: COVID-19 pandemic.
+Added: As a result, the Company does not anticipate and has not experienced any material impairments with respect to any of its long-lived assets, including the Company’s property and equipment, goodwill or intangible assets.
ADMA BIOLOGICS, INC.
1 unchanged sentence
NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Notwithstanding the foregoing, the COVID-19 pandemic to date has not had a material impact on the Company’s financial
−Removed: condition or results of operations, and the Company does not believe that its production operations at the Boca Facility, the Company’s contract fill/finishers or its plasma collection facilities have been significantly impacted by the COVID-19
−Removed: As a result, the Company does not anticipate and has not experienced any material impairments with respect to any of its long-lived assets, including the Company’s property and equipment, goodwill or intangible assets.
Although the COVID-19 pandemic has not, to date, materially adversely impacted the Company’s capital and financial
12 unchanged sentences
2027, after which it may be renewed for two additional five-year periods if agreed to by the parties.
−Removed: On December 10, 2018, BPC assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations
−Removed: Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019.
−Removed: On January 1, 2019, Grifols and the Company entered into an additional amendment to the 2011 Plasma Purchase Agreement for the purchase of source plasma containing
−Removed: antibodies to RSV from Grifols.
−Removed: Pursuant to this amendment, until January 1, 2022, the Company could purchase RSV plasma from Grifols from the two
−Removed: plasma collection centers that were transferred to BPC on January 1, 2019 at a price equal to cost plus five percent ( 5 %) (without any additional increase due to inflation).
−Removed: Effective January 1, 2022, RSV plasma purchased from these two plasma collection centers are subject to the pricing terms in effect for RSV plasma purchased from other plasma collection centers owned by
+Added: On December 10, 2018, BPC assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide
+Added: Operations Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019.
+Added: On January 1, 2019, Grifols and the Company entered into an additional amendment to the 2011 Plasma Purchase Agreement for the purchase of source plasma
+Added: containing antibodies to RSV from Grifols.
+Added: Pursuant to this amendment, until January 1, 2022, the Company could purchase RSV plasma from Grifols from the two plasma collection centers that were transferred to BPC on January 1, 2019 at a price equal to cost plus five percent ( 5 %) (without any additional increase due to inflation).
+Added: Effective January 1, 2022, RSV plasma purchased
+Added: from these two plasma collection centers are subject to the pricing terms in effect for RSV plasma purchased from other plasma
+Added: collection centers owned by Grifols.
On June 6, 2017, the Company and BPC entered into a Plasma Supply Agreement pursuant to which BPC supplies, on an
8 unchanged sentences
pursuant to which ADMA BioManufacturing purchases normal source plasma (“NSP”) from BPC at agreed upon annual quantities and prices.
−Removed: On July 19, 2018, the Company and BPC entered into an amendment to the 2017 Plasma Purchase Agreement to, among
−Removed: other things, provide agreed upon amounts of normal source plasma to be supplied by BPC to ADMA BioManufacturing in calendar year 2019 at a specified price per liter, provided that ADMA BioManufacturing delivers a valid purchase order to BPC.
−Removed: Additionally, pursuant to the amendment to the 2017 Plasma Purchase Agreement, BPC agreed that, for calendar years 2020 and 2021, it shall supply no less than a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts,
−Removed: provided that such requested NSP amounts are within an agreed range, at a price per liter to be mutually determined.
−Removed: Furthermore, pursuant to the amendment to the 2017 Plasma Purchase Agreement, in the event BPC fails to supply ADMA
−Removed: BioManufacturing with at least a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, BPC shall promptly reimburse ADMA BioManufacturing the difference in price ADMA BioManufacturing incurs due to BPC’s election not to
−Removed: supply NSP to ADMA BioManufacturing in such amounts as requested.
−Removed: On December 10, 2018, BPC assigned its rights and obligations under the Plasma Purchase Agreement to Grifols, effective January 1, 2019.
+Added: The 2017 Plasma Purchase Agreement has an initial term of five years after which the 2017 Plasma Purchase Agreement may be renewed for additional two terms of two years each upon the mutual written consent of the
+Added: On July 19, 2018, the Company and BPC entered into an amendment to the 2017 Plasma Purchase Agreement to, among other things, provide agreed upon amounts of normal source plasma to be supplied by BPC to ADMA
+Added: BioManufacturing in calendar year 2019 at a specified price per liter, provided that ADMA BioManufacturing delivers a valid purchase order to BPC.
+Added: Additionally, pursuant to the amendment to the 2017 Plasma Purchase Agreement, BPC agreed that,
+Added: for calendar years 2020 and 2021, it shall supply no less than a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, provided that such requested NSP amounts are within an agreed range, at a price per liter to be
+Added: mutually determined.
+Added: Furthermore, pursuant to the amendment to the 2017 Plasma Purchase Agreement, in the event BPC fails to supply ADMA BioManufacturing with at least a high double-digit percentage of ADMA BioManufacturing’s requested NSP
+Added: amounts, BPC shall promptly reimburse ADMA BioManufacturing the difference in price ADMA BioManufacturing incurs due to BPC’s election not to supply NSP to ADMA BioManufacturing in such amounts as requested.
+Added: On December 10, 2018, BPC assigned
+Added: its rights and obligations under the Plasma Purchase Agreement to Grifols, effective January 1, 2019.
ADMA BIOLOGICS, INC.
10 unchanged sentences
Company purchased substantially all of its raw material plasma from Grifols.
−Removed: For the three months ended March 31, 2023, plasma purchases from Grifols totaled $ 11.6 million, or approximately 40 % of the Company’s total inventory
−Removed: For the three months ended March 31, 2022, plasma purchases from Grifols totaled approximately $ 15.5 million, representing
−Removed: approximately 75 % of the Company’s total inventory purchases.
+Added: For the six months ended June 30, 2023, plasma purchases from Grifols totaled $ 5.2 million, or approximately 26 % of the Company’s total inventory purchases.
+Added: For the six months
+Added: ended June 30, 2022, plasma purchases from Grifols totaled $ 22.8 million, representing approximately 66 % of the Company’s total inventory purchases.
Post-Marketing Commitments
−Removed: In connection with
−Removed: the approval of the BLA for BIVIGAM, on December 19, 2012, Biotest committed to perform two additional post-marketing studies, a pediatric study to evaluate the efficacy and safety of BIVIGAM in children and adolescents, and a
−Removed: post-authorization safety study to further assess the potential risk of hypotension and hepatic and renal impairment in BIVIGAM-treated patients with primary humoral immunodeficiency.
−Removed: The pediatric study for BIVIGAM has been completed, and the safety study has been completed pending a clinical study report to
−Removed: ADMA has assumed the remaining obligations, and the costs of the studies will be expensed as incurred as research and development expenses.
−Removed: For the three months ended March 31, 2023 and 2022, the Company incurred expenses
−Removed: related to these studies of $ 0.4 million.
−Removed: The Company currently expects to incur expenses of approximately $ 1.5 million to $ 2.0 million to
−Removed: complete the safety study, which is required to be completed by June of 2023.
−Removed: In connection with
−Removed: the FDA’s approval of ASCENIV on April 1, 2019, the Company is required to perform a pediatric study to evaluate the safety and efficacy of ASCENIV in children and adolescents.
−Removed: For the three months ended March 31, 2023 and 2022, the Company
−Removed: incurred expenses related to these studies in the amount of $ 0.2 million and $ 0.1 million, respectively.
−Removed: The Company expects to incur expenses of approximately $ 1.5 million to complete this study, which is currently required to be completed by June of 2023.
−Removed: The Company has submitted an extension request to the FDA.
+Added: In connection with the approval of the BLA for BIVIGAM, on December 19, 2012, Biotest committed to perform two
+Added: additional post-marketing studies, a pediatric study to evaluate the efficacy and safety of BIVIGAM in children and adolescents, and a post-authorization safety study to further assess the potential risk of hypotension and hepatic and renal
+Added: impairment in BIVIGAM-treated patients with primary humoral immunodeficiency.
+Added: These studies were required to be completed by June of 2023 and both studies have been completed and the study reports have been submitted to the FDA.
+Added: assumed the remaining obligations, and the costs of the studies have been expensed as incurred as research and development expenses.
+Added: For the six months ended June 30, 2023 and 2022, the Company incurred expenses related to these studies of $ 1.4 million and $ 0.9 million,
+Added: respectively.
+Added: In connection with the FDA’s approval of ASCENIV on April 1, 2019, the Company is required to perform a
+Added: pediatric study to evaluate the safety and efficacy of ASCENIV in children and adolescents.
+Added: For the six months ended June 30, 2023 and 2022, the Company incurred expenses related to this study in the amount of $ 0.4 million and $ 0.2 million,
+Added: respectively.
+Added: The Company expects to incur expenses of approximately $ 1.5 million to complete this study, which is required to be
+Added: completed by June of 2026.
Employment Contracts
2 unchanged sentences
Chief Financial Officer and General Manager, ADMA BioCenters.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Other Commitments
3 unchanged sentences
The Company’s maximum exposure under these arrangements is
−Removed: unknown as of March 31, 2023.
+Added: unknown as of June 30, 2023.
The Company does not anticipate recognizing any significant losses relating to these arrangements.
−Removed: The Company is engaged in the manufacture, marketing and development of specialty plasma-derived biologics.
−Removed: Company’s ADMA BioManufacturing segment reflects the Company’s immunoglobulin manufacturing, commercial and development operations in Boca Raton, FL.
−Removed: The Plasma Collection Centers segment consists of ten operational plasma collection facilities located throughout the U.S., eight of which currently hold FDA licenses .
+Added: ADMA BIOLOGICS, INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: The Company is engaged in the manufacture, marketing and development of specialty plasma-derived
+Added: The Company’s ADMA BioManufacturing segment reflects the Company’s immunoglobulin manufacturing, commercial and development operations in Boca Raton, FL.
+Added: The Plasma Collection Centers segment consists of ten operational plasma collection facilities located throughout the U.S., nine of which currently hold FDA licenses .
The Corporate segment includes general and administrative overhead expenses.
−Removed: The Company defines its segments as those business units whose operating results are regularly reviewed by the chief operating decision maker (“CODM”) to analyze
−Removed: performance and allocate resources.
+Added: The Company defines its segments as those
+Added: business units whose operating results are regularly reviewed by the chief operating decision maker (“CODM”) to analyze performance and allocate resources.
The Company’s CODM is its President and Chief Executive Officer.
Summarized financial information concerning reportable segments is shown in the following tables:
−Removed: Three Months Ended March 31, 2023
+Added: Three Months Ended June 30, 2023
+Added: BioManufacturing
Plasma Collection
+Added: Cost of product revenue
+Added: Income (loss) from operations
+Added: Interest and other (expense) income, net
+Added: Net income (loss)
+Added: Depreciation and amortization expense
+Added: Three Months Ended June 30, 2022
+Added: Plasma Collection
BioManufacturing
Cost of product revenue
+Added: Loss from operations
+Added: Interest and other expense, net
+Added: Depreciation and amortization expense
+Added: ADMA BIOLOGICS, INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Six Months Ended June 30, 2023
+Added: Plasma Collection
+Added: BioManufacturing
+Added: Cost of product revenue
Income (loss) from operations
3 unchanged sentences
Depreciation and amortization expense
−Removed: Three Months Ended March 31, 2022
+Added: Six Months Ended June 30, 2022
Plasma Collection
6 unchanged sentences
Depreciation and amortization expense
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Net revenues according to geographic area, based on the location of where the product is shipped, is as follows:
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
United States
6 unchanged sentences
or material restrictive covenants.
+Added: ADMA BIOLOGICS, INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The Company determines if an arrangement is an operating lease at inception.
10 unchanged sentences
straight-line basis over the lease term and is reflected in Plasma center operating expenses and Selling, general and administrative expenses.
−Removed: Aggregate lease expense for the Company’s leases for the three months ended March 31, 2023 and 2022
−Removed: was approximately $ 0.6 million and $ 0.4
−Removed: million, respectively.
−Removed: Cash paid for the Company’s leases for the three months ended March 31, 2023 and 2022 was approximately $ 0.6
−Removed: million and $ 0.4 million, respectively.
−Removed: Including a finance lease the Company entered into in June 2018, the Company has aggregate lease
−Removed: liabilities of $ 11.4 million and $ 11.6
−Removed: million as of March 31, 2023 and December 31, 2022, respectively, which are comprised primarily of the leases for the Company’s plasma collection centers and a warehouse lease for raw material storage related to the Company’s immunoglobulin
−Removed: manufacturing operations.
−Removed: The Company’s operating leases have a weighted average remaining term of 8.3 years.
−Removed: Scheduled payments under the
−Removed: Company’s lease obligations are as follows:
+Added: Aggregate lease expense for the Company’s leases for the three months ended June 30, 2023 and 2022 was approximately $ 0.6 million and $ 0.5 million, respectively, and aggregate
+Added: lease expense for the six months ended June 30, 2023 and 2022 was $ 1.2 million and $ 0.9 million, respectively.
+Added: Cash paid for the Company’s leases for the three months ended June 30, 2023 and 2022 was approximately $ 0.6 million and $ 0.4 million,
+Added: respectively, and cash paid for the six months ended June 30, 2023 and 2022 was approximately $ 1.1 million and $ 0.8 million, respectively.
+Added: The Company has aggregate lease liabilities of $ 11.2 million and $ 11.6 million as of June 30, 2023 and December 31, 2022,
+Added: respectively, which are comprised primarily of the leases for the Company’s plasma collection centers and a warehouse lease for raw material storage related to the Company’s immunoglobulin manufacturing operations.
+Added: The Company’s operating
+Added: leases have a weighted average remaining term of 8.1 years.
+Added: Scheduled payments under the Company’s lease obligations are as follows:
Remainder of 2023
3 unchanged sentences
Current portion
−Removed: Balance at March 31, 2023
+Added: Balance at June 30, 2023
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
−Removed: Supplemental cash flow information for the three months ended March 31, 2023 and 2022 is as follows:
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO (UNAUDITED) CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Supplemental cash flow information for the six months ended June 30, 2023 and 2022 is as follows:
SUPPLEMENTAL CASH FLOW INFORMATION:
2 unchanged sentences
Equipment acquired reflected in accounts payable and accrued liabilities
+Added: Right-to-use assets in exchange for lease obligations
Warrants issued in connection with notes payable
−Removed: SUBSEQUENT EVENT
−Removed: On May 1, 2023, the Company entered into a second amendment (the “Hayfin Second Amendment”) to the
−Removed: Hayfin Credit Agreement (see Note 7) whereby the Applicable Margin for adjusted Term SOFR Loans was reduced from 9.5 % to 8.5 %.
−Removed: The Hayfin Second Amendment also extended the obligation of the lenders to make the Hayfin Delayed Draw Loan from June 30, 2023 to December 31,
−Removed: Under the terms of the Hayfin Second Amendment, in the event the Company elects to prepay all or any
−Removed: portion of the outstanding principal on the Hayfin Loans, the Company will be subject to an early prepayment fee in the amount equal to (i) 7.0 %
−Removed: of the prepaid principal amount, if prepaid on or prior to the first anniversary of the Hayfin Second Amendment, (ii) 3.0 % of the prepaid
−Removed: principal amount, if prepaid after the first anniversary of the Hayfin Second Amendment and on or prior to the second anniversary of the Hayfin Second Amendment, or (iii) 1.0 % of the prepaid principal amount, if prepaid after the second anniversary of the Hayfin Second Amendment and on or prior to the third anniversary of the Hayfin Second Amendment.
−Removed: addition, the Hayfin Second Amendment provides for a 50 % reduction to the foregoing early prepayment fees if the Hayfin Loans are prepaid
−Removed: in connection with a change in control of the Company or other strategic transactions as further described in the Hayfin Second Amendment.
−Removed: In connection with the Hayfin Second Amendment, the Company issued additional warrants to the lenders
−Removed: to purchase 2,391,244 shares of the Company’s common stock at an exercise price of $ 3.2619 per share (“the Hayfin Second Amendment Warrants”).
−Removed: The Hayfin Second Amendment Warrants were valued at approximately $ 5.6 million and have an expiration date of May 1, 2030.
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.