Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, our principal executive and principal financial officers, respectively, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended, as of the end of the period covered by this Annual Report on Form 10-K. Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective (a) to ensure that information that we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms and (b) to include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in reports filed or submitted under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Exchange Act. Under the supervision and with the participation of senior management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of our internal control over financial reporting based on the framework in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 2013. Based on the evaluation under that framework and applicable SEC rules, our management concluded that our internal control over financial reporting was effective as of December 31, 2020 .
Our internal control over financial reporting as of December 31, 2020 has been audited by Ernst & Young, LLP, an independent registered public accounting firm, as stated in their report appearing below.
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2020, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act).
Inherent Limitations of Internal Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management overriding of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Amphastar Pharmaceuticals, Inc.
Opinion on Internal Control Over Financial Reporting
We have audited Amphastar Pharmaceuticals, Inc. internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), (the COSO criteria). In our opinion, Amphastar Pharmaceuticals, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2020, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2020 and 2019, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2020, and the related notes and our report dated March 15, 2021 expressed an unmodified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control Over Internal Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
Irvine, California
March 15, 2021
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Item 9B. Other Information.
None.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Information required by this item will be included in our Proxy Statement for our 2021 Annual Meeting of Stockholders to be filed within 120 days after our fiscal year end of December 31, 2020, or 2021 Proxy Statement, and is incorporated by reference into this Annual Report on Form 10-K.
Item 11. Executive Compensation.
Information required by this item will be included in our 2021 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Information required by this item will be included in our 2021 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
RELATED PERSON TRANSACTIONS
Policies and Procedures for Related Party Transactions
As set forth in our audit committee charter, our audit committee is primarily responsible for reviewing and approving related-party transactions, which consist of all transactions and series of similar transactions to which we were a party or will be a party and in which any of our directors, executive officers and holders of more than 5% of our voting securities and their respective affiliates has a direct or indirect material interest. As used in this section, the terms “related person” and “transaction” have the meanings set forth in Item 404(a) of Regulation S-K under the Securities Act. In the course of its review and approval of transactions with related persons, the audit committee considers:
● the nature of the related person’s interest in the transaction;
● the material terms of the transaction, including the amount involved and the type of the transaction;
● the importance of the transaction to the related person and to Amphastar;
● whether the transaction would impair the judgment of a director or executive officer to act in our best interest and the best interest of our stockholders; and
● any other matters the audit committee deems appropriate.
Any member of the audit committee or, if applicable, our board of directors, who is a related person with respect to a transaction under review will not be able to participate in the discussions or vote on the approval or ratification of the transaction, other than to provide all material information regarding the transaction, including information regarding the extent of the member’s interest in the transaction, to the audit committee. Any material changes to the terms of, or any renewal of, any of these transactions will also require the same approval. If a related party transaction will be ongoing, the audit committee may establish guidelines or other parameters or conditions relating to our participation in the transaction. The audit committee may from time to time pre-approve types or categories of transactions by related persons.
Related Person Transactions
We describe below transactions and series of similar transactions, since the beginning of our last fiscal year, or not
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previously disclosed, to which we were a party or will be a party, in which:
● the amounts involved exceeded or will exceed $120,000; and
● any of our directors, nominees for director, executive officers or holders of more than 5% of our outstanding capital stock, or any immediate family member of, or person sharing the household with, any of these individuals or entities, had or will have a direct or indirect material interest.
Employment of Related Persons
James Luo
James Luo, the brother of Dr. Mary Luo, our Chairman of the Board, Chief Operating Officer and Chief Scientist, and the brother-in-law of Dr. Jack Zhang, our Chief Executive Officer, President, Chief Scientific Officer and director, was employed by us from 2003 until his retirement in 2020, most recently as our Senior Vice President of New Engineering Research Center, and President of Amphastar France Pharmaceuticals. In connection with his retirement in 2020, Mr. Luo received a retirement package that included $992,000 of cash payments over a three year period beginning in 2021 as well as $118,000 of health insurance payments over a six year period. In addition, Mr. Luo’s total compensation since 2014, the year of our initial public offering, was as follows:
Year
Salary
Bonus
Restricted Stock Awards (1)
Option Awards (1)
All Other Compensation (2)
Total
2020
$
347,000
$
—
$
150,500
$
150,500
$
50,400
$
698,400
2019
$
385,000
$
$62,300
$
144,000
$
144,000
$
8,300
$
743,600
2018
$
368,300
$
$76,200
$
121,500
$
121,500
$
8,200
$
695,700
2017
$
352,000
$
$94,000
$
149,500
$
111,500
$
8,000
$
715,000
2016
$
338,500
$
$64,900
$
108,500
$
108,500
$
7,700
$
628,100
2015
$
322,400
$
$69,400
$
96,500
$
96,500
$
5,300
$
590,100
2014
$
313,000
$
$56,200
$
49,700
$
92,300
$
5,200
$
516,400
(1) This amount reflects the aggregate grant fair value computed in accordance with ASC Topic 718.
(2)
All years include a company contribution under our 401(K) plan. In addition, 2020 includes a payment of $40,800 for travel incentives in accordance with our travel policy, which had been earned but not paid during the previous five years.
We believe that Mr. Luo’s compensation, including his retirement payment, is comparable with compensation paid to other employees with similar levels of responsibility and years of experience.
Henry Zhang
Henry Zhang (Haoning Zhang), the son of Dr. Jack Zhang and Dr. Mary Luo, is employed by us as the General Manager of Amphastar Nanjing Pharmaceuticals (ANP) and has been employed in that role since 2009. Mr. Zhang’s compensation since 2014, the year of our initial public offering, was as follows:
Year
Salary
Bonus
Restricted Stock Awards (1)
Option Awards (1)
Total
2020
$
192,600
$
104,300
$
—
$
617,400
$
914,300
2019
$
180,000
$
141,300
$
—
$
535,000
$
856,300
2018
$
150,000
$
99,200
$
79,500
$
422,100
$
750,800
2017
$
114,800
$
74,700
$
66,000
$
66,000
$
321,500
2016
$
113,800
$
62,900
$
60,500
$
60,500
$
297,700
2015
$
108,000
$
60,700
$
55,500
$
55,500
$
279,700
2014
$
102,900
$
44,500
$
—
$
101,000
$
248,400
(1) This amount reflects the aggregate grant fair value computed in accordance with ASC Topic 718.
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Mr. Zhang’s compensation was approved by the board of directors of ANP beginning in 2018. Prior to that it was set by our management and was comparable with compensation paid to other general managers of our facilities.
Other Employment Relationships
Qingqing Chen, who married Henry Zhang in 2012, was employed by ANP until January 2015, when she resigned. Ms. Chen served in an administrative role and her total annual compensation never exceeded $10,000.
Chongqing Zhang, the brother of Dr. Jack Zhang and the brother-in-law of Dr. Mary Luo, has worked for ANP since 2009, initially as a facilities manager, then as a support manager, and more recently, serving as labor union chairman. At no time has his total annual compensation exceeded $80,000.
ANP Private Placement
As previously disclosed, in July 2018, ANP completed a private placement of its equity to accredited investors for aggregate gross proceeds of approximately $56.3 million. In connection with the private placement, all of our executive officers at that time, including current executive officers Dr. Mary Luo, Dr. Jack Zhang, Bill Peters, Rong Zhou, and Jacob Liawatidewi, and our independent directors Howard Lee and Richard Koo and former director Stephen Shohet, entered into subscription agreements for the indirect investment in ANP (the “ANP Private Placement”). Both Mr. Lee and Mr. Koo invested, in whole or in part, through other immediate family members. These subscription agreements were transacted either through an investment in Amphastar Cayman LLC, a Cayman Islands limited liability company, or Qianqia, a Chinese partnership.
In addition, certain immediate family members of Dr. Jack Zhang and Dr. Mary Luo invested indirectly in the ANP Private Placement as set forth below:
Investor
Relationship to Dr. Jack Zhang and Dr. Mary Luo
Investment
Henry Zhang and Qingqing Chen
Son and daughter-in-law, respectively
$
9,956,000
Chongqing Zhang
Brother of Dr. Jack Zhang, brother-in-law of Dr. Mary Luo
$
400,000
Bill Zhang
Son
$
3,200,000
Lu Zhang
Daughter
$
2,500,000
James Luo
Brother of Dr. Mary Luo, brother-in-law of Dr. Jack Zhang
$
100,000
The total aggregate gross proceeds received from such executive officers, directors and related parties were approximately $36.4 million. After the private placement, we retained approximately 58% of the equity interest of ANP immediately after the private placement.
Huilu Health Products LLC
Lu Zhang and Guohui Zhang, the daughter and son-in-law of Dr. Jack Zhang and Dr. Mary Luo, are the owners of Huilu Health Products LLC, or Huilu. In 2020, Huilu resold our Primatene Mist product on Amazon.com pursuant to a distribution arrangement on terms consistent with those we have entered into with other similar-sized distribution partners. In connection with this arrangement, we recognized revenue of $224,000 in 2020 relating to Huilu’s purchase of our Primatene Mist product, the pricing of which was negotiated in good faith and was consistent with the price at which we sold to other distribution partners.
Nanjing Baiziya Biotechnology Co., Ltd.
Henry Zhang, the son of Dr. Jack Zhang and Dr. Mary Luo, holds a majority interest in Baiziya, which was formed and organized in 2019. In 2020, Baiziya entered into a series of transactions with ANP through which ANP supplied non-prescription healthcare products and cosmetics to Baiziya. We believe that the pricing agreed to with Baiziya was negotiated in good faith. The net total of the transactions in 2020, after giving effect to certain cancellations, was $90,000.
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Other Transactions
We have granted stock options and RSUs to our executive officers and certain of our directors.
We have entered into employment agreements with certain of our executive officers that, among other things, provides for certain severance and change in control benefits.
Additional information related to these transactions will be set forth in our 2021 Proxy Statement which is incorporated by reference in Part III, Item 11 of this Annual Report on Form 10-K.
Indemnification Agreements
We have entered into indemnification agreements with each of our directors and executive officers. The indemnification agreements, our amended and restated certificate of incorporation and our amended and restated bylaws require us to indemnify our directors to the fullest extent permitted by Delaware law.
Item 14. Principal Accountant Fees and Services.
Information required by this item will be included in our 2021 Proxy Statement and is incorporated by reference into this Annual Report on Form 10-K.
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PART IV
Item 15. Exhibits and Financial Statement Schedules.
(a) (1) Financial Statements filed as part of this report are listed in Part II, Item 8 of this report.
(2) No other financial schedules have been included because they are not applicable, not required or because required information is included in the consolidated financial statements or notes thereto.
(b) The following exhibits are filed as part of, or incorporated by reference into, this Annual Report on Form 10-K.
HIDDEN_ROW
Exhibit
No.
Description
3.1
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 1, 2014)
3.2
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.4 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
4.1
Specimen common stock certificate (incorporated by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on June 5, 2014)
4.2
Description of Securities Registered Under Section 12 of the Exchange Act
10.1+
Amended and Restated 2005 Equity Incentive Award Plan (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.2+
Form of Stock Option Grant Notice and Stock Option Agreement under the Amended and Restated 2005 Equity Incentive Award Plan (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.3+
Form of Deferred Stock Unit Notice of Grant and Deferred Stock Unit Agreement under the Amended and Restated 2005 Equity Incentive Award Plan (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.4
Business Loan Agreement, dated December 31, 2010, between International Medication Systems, Limited and East West Bank, as amended (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.5
Revolving Loan and Security Agreement, dated April 10, 2012, between Amphastar Pharmaceuticals, Inc. and Cathay Bank (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.6◊
Transfer Contract for the Right to the Use of State-owned Land, dated December 29, 2009, between Amphastar Nanjing Pharmaceuticals Co., Ltd. and Nanjing Xingang Hi-Tech Company Limited (incorporated by reference to Exhibit 10.13 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.7◊
Investment Agreement, dated July 5, 2010, between Amphastar Nanjing Pharmaceuticals Co., Ltd. and the Management Committee of the Nanjing Economic and Technological Development Zone (incorporated by reference to Exhibit 10.14 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.8◊
Transfer Contract for the Right to the Use of State-owned Land, dated December 31, 2010, between Amphastar Nanjing Pharmaceuticals Co., Ltd. and Nanjing Xingang Hi-Tech Company Limited. (incorporated by reference to Exhibit 10.15 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.9+
2014 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.17 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.10
Asset Purchase Agreement, dated April 30, 2014, among Diosynth France, Amphastar France Pharmaceuticals SAS and Schering-Plough (incorporated by reference to Exhibit 10.18 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
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10.11
Loan Agreement, dated April 22, 2014, between Amphastar Pharmaceuticals, Inc. and Cathay Bank (incorporated by reference to Exhibit 10.19 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.12
Promissory Note, dated April 22, 2014, by Amphastar Pharmaceuticals, Inc. payable to Cathay Bank in the original principal sum of $21,900,000 (incorporated by reference to Exhibit 10.20 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.13+
Employment Agreement, dated May 19, 2014, between Amphastar Pharmaceuticals, Inc. and Jack Zhang (incorporated by reference to Exhibit 10.21 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.14+
Employment Agreement, dated May 19, 2014, between Amphastar Pharmaceuticals, Inc. and Mary Luo (incorporated by reference to Exhibit 10.22 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.15+
Employment Agreement, dated March 11, 2014, between Amphastar Pharmaceuticals, Inc. and William Peters (incorporated by reference to Exhibit 10.25 to the Company’s Registration Statement on Form S-1 filed with the SEC on May 20, 2014)
10.16†
Supply Agreement, dated July 31, 2014, between MannKind Corporation and Amphastar France Pharmaceuticals, S.A.S. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2014)
10.17
First Amendment to Supply Agreement, dated October 31, 2014, by and between MannKind Corporation, Amphastar France Pharmaceuticals, S.A.S., and Amphastar Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2014)
10.18
Business Loan Agreement, dated January 28, 2016, between Amphastar Pharmaceuticals, Inc. and East West Bank in the original principal sum of $3,724,841. (incorporated by reference to Exhibit 10.28 to the Company’s Annual Report on Form 10-K filed with the SEC on March 15, 2016)
10.19
Equipment Line of Credit Agreement, dated March 7, 2016, between International Medication Systems, Limited and East West Bank in the principal sum of $5,000,000. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 10, 2016)
10.20
Fifth Modification to the Revolving Line of Credit Agreement, dated March 7, 2016, between International Medication Systems, Limited and East West Bank in the principal sum of $15,000,000. (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 10, 2016)
10.21
Fourth Modification to the Revolving Line of Credit Agreement, dated June 23, 2016, between Amphastar Pharmaceuticals, Inc. and Armstrong Pharmaceuticals, Inc. and Cathay Bank in the principal sum of $20,000,000. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2016)
10.22
Business Loan Agreement, dated September 8, 2016, between Amphastar Pharmaceuticals, Inc. and East West Bank in the original principal sum of $3,591,250. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2016)
10.23†
Second Amendment to Supply Agreement, dated November 9, 2016, by and between MannKind Corporation, Amphastar France Pharmaceuticals, S.A.S., and Amphastar Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.34 to the Company’s Annual Report on Form 10-K filed with the SEC on March 15, 2017)
10.24
Business Loan Agreement, dated May 11, 2017, between International Medication Systems, Limited and East West Bank in the original principal sum of $5,000,000. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2017)
10.25
Business Loan Agreement, dated May 18, 2017, between Amphastar Pharmaceuticals, Inc. and East West Bank in the original principal sum of $9,000,000. (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2017)
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10.26
Sixth Modification to the Revolving Line of Credit Agreement, dated May 3, 2017, between International Medication Systems, Limited and East West Bank in the principal sum of $15,000,000. (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2017)
10.27
Equipment Line of Credit, dated June 28, 2017, between International Medication Systems, Limited and East West Bank in the original principal sum of $8,000,000. (incorporated by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2017)
10.28
Business Loan Agreement, dated August 14, 2017, between Armstrong Pharmaceuticals, Inc. and Cathay Bank in the original principal sum of $7,865,000. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2017)
10.29
Partnership Agreement by and between Zhang Chongqing, Bill Zhang and Applied Physics & Chemistry Laboratories, Inc. dated July 27, 2018. (incorporated by reference to Exhibit 10.9 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2018)
10.30
Fourth Amendment to Supply Agreement, dated December 24, 2018, by and between MannKind Corporation and Amphastar Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.45 to the Company’s Annual Report on Form 10-K filed with the SEC on March 15, 2018)
10.31
Equipment Line of Credit, dated January 8, 2019, between International Medication Systems, Limited and East West Bank in the original principal sum of $10,000,000. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 10, 2019)
10.32
First Modification to the Loan Agreement, dated April 22, 2019, between Amphastar Pharmaceuticals, Inc. and Cathay Bank. (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 10, 2019)
10.33
Ninth Amendment to the Acquisition Loan, dated July 19, 2019 between Amphastar Pharmaceuticals, Inc. and Cathay Bank. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2019)
10.34*
Fifth Amendment to the Supply Agreement by and between MannKind Corporation and Amphastar Pharmaceuticals, Inc., dated August 2, 2019. (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 9, 2019)
10.35
Amphastar Pharmaceuticals, Inc. Employee Deferred Compensation Plan, effective December 1, 2019. (incorporated by reference to Exhibit 10.39 to the Company’s Annual Report on Form 10-K filed with the SEC on March 16, 2020)
10.36 +
Separation Agreement and General Release of Claims by and between the Amphastar Pharmaceuticals, Inc. and Jason Shandell dated as of April 13, 2020. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 7, 2020)
10.37
Eighth Modification to the Revolving Line of Credit Agreement, dated June 15, 2020, between Amphastar Pharmaceuticals, Inc. and Armstrong Pharmaceuticals, Inc. and Cathay Bank in the principal sum of $20,000,000. (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 7, 2020)
10.38
Equipment Line of Credit, dated September 1, 2020, between International Medication Systems, Limited and East West Bank in the original sum of $10,000,000. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 6, 2020)
10.39+
Amphastar Pharmaceuticals, Inc. 2015 Equity Incentive Plan, as amended and restated effective as of November 3, 2020 (incorporated by reference to Exhibit 99.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 6, 2020)
10.40
Eight Modification to the Revolving Line of Credit Agreement, dated March 7, 2016, between International Medication Systems, Limited and East West Bank in the principal sum of $15,000,000.
21.1
Subsidiaries of the Company
23.1
Consent of Independent Registered Public Accounting Firm
24.1
Power of Attorney (included in signature pages hereto)
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31.1
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1#
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2#
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
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101.SCH
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Cover Page Interactive File (formatted as Inline XBRL and contained in Exhibit 101)
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The information in Exhibits 32.1 and 32.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act (including this Report), unless the registrant specifically incorporates the foregoing information into those documents by reference.
*
Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10).
+
Indicates a management contract or compensatory plan or arrangement.
◊ English translation of original Chinese document.
†
Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and file separately with the SEC.
Item 16. Form 10-K Summary.
None.
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Table of Contents
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
AMPHASTAR PHARMACEUTICALS, INC.
(Registrant)
By:
/s/ JACK Y. ZHANG
Jack Y. Zhang
Chief Executive Officer
(Principal Executive Officer)
Date: March 15, 2021
AMPHASTAR PHARMACEUTICALS, INC.
(Registrant)
By:
/s/ WILLIAM J. PETERS
William J. Peters
Chief Financial Officer
(Principal Financial and Accounting Officer)
Date: March 15, 2021
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Table of Contents
POWER OF ATTORNEY
Each person whose signature appears below constitutes and appoints Jack Y. Zhang and William J. Peters, and each of them, as his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their or his substitutes, may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the date indicated:
Signature
Title
Date
/s/ JACK Y. ZHANG
Chief Executive Officer, President, and Director
March 15, 2021
Jack Yongfeng Zhang
(Principal Executive Officer)
/s/ MARY Z. LUO
Chairman, Chief Operating Officer
March 15, 2021
Mary Z. Luo
and Director
/s/ WILLIAM J. PETERS
Chief Financial Officer (Principal
March 15, 2021
William J. Peters
Financial and Accounting Officer)
/s/ RICHARD KOO
Director
March 15, 2021
Richard Koo
/s/ HOWARD LEE
Director
March 15, 2021
Howard Lee
/s/ FLOYD PETERSEN
Director
March 15, 2021
Floyd Petersen
/s/ RICHARD PRINS
Director
March 15, 2021
Richard Prins
/s/ DIANE G. GERST
Director
March 15, 2021
Diane G. Gerst
/s/ MICHAEL A. ZASLOFF
Director
March 15, 2021
Michael A. Zasloff
/s/ DAVID MARIS
Director
March 15, 2021
David Maris
151