0001193125-21-237030.txt : 20210805 0001193125-21-237030.hdr.sgml : 20210805 20210805075035 ACCESSION NUMBER: 0001193125-21-237030 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20210730 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210805 DATE AS OF CHANGE: 20210805 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Athenex, Inc. CENTRAL INDEX KEY: 0001300699 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 431985966 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38112 FILM NUMBER: 211146375 BUSINESS ADDRESS: STREET 1: 1001 MAIN STREET STREET 2: SUITE 600 CITY: BUFFALO STATE: NY ZIP: 14203 BUSINESS PHONE: 716-898-8625 MAIL ADDRESS: STREET 1: 1001 MAIN STREET STREET 2: SUITE 600 CITY: BUFFALO STATE: NY ZIP: 14203 FORMER COMPANY: FORMER CONFORMED NAME: Kinex Pharmaceuticals, Inc. DATE OF NAME CHANGE: 20131223 FORMER COMPANY: FORMER CONFORMED NAME: Kinex Pharmaceuticals LLC DATE OF NAME CHANGE: 20040817 8-K 1 d37907d8k.htm 8-K 8-K
false 0001300699 0001300699 2021-07-30 2021-07-30

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 30, 2021

 

 

ATHENEX, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38112   43-1985966
(State or other jurisdiction
of incorporation)		   (Commission
File Number)		   (IRS Employer
Identification No.)

 

1001 Main Street, Suite 600, Buffalo, New York   14203
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (716) 427-2950

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

  ☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  ☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

Title of each class

  

Trading Symbol(s)

  

Name of each exchange on which registered

Common Stock, par value $0.001 per share   ATNX   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 2.02

Results of Operations and Financial Condition.

On August 5, 2021, Athenex, Inc. (the “Company”) issued a press release to report financial results for the quarter ended June 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information furnished pursuant to this Item 2.02, including Exhibit 99.1, 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 under such section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act.

 

Item 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On July 30, 2021, Randoll Sze, the Company’s Chief Financial Officer and the principal financial and accounting officer, notified the Company of his decision to step down effective August 13, 2021.

On August 3, 2021, the Company appointed Steven Adams as Interim Chief Accounting Officer of the Company and to act as the Company’s principal financial officer and principal accounting officer for Securities and Exchange Commission reporting purposes. Mr. Adams, age 53, has been serving as the Company’s Corporate Controller since December 2013. Prior to his employment with the Company, Mr. Adams worked with cfoSOLUTIONSplus providing accounting management consulting services, a position he held since May 2007. One of the clients that he provided consulting services to, while he was with cfoSOLUTIONSplus, was Athenex. Prior to his time with cfoSOLUTIONSplus, Mr. Adams held a variety of accounting positions in both corporate and public accounting, this included positions at KPMG and Sodexo. Mr. Adams is certified public accountant licensed in New York.

In connection with his appointment, the Board approved (i) a one-time $35,000 cash bonus payable over 6 months, and (ii) two milestone based cash bonuses for service as interim Chief Accounting Officer, the first being $15,000 paid May 2021 and the second being $20,000 payable January 2022. Additionally, on August 3, 2021, the Board granted Mr. Adams an award pursuant to the Company’s Amended and Restated 2017 Omnibus Incentive Plan of 12,500 stock options at an exercise price of $3.80 per share, which vest in four equal annual installments beginning on the anniversary of the date of grant, and 12,500 restricted stock units.

There is no arrangement or understanding with any person pursuant to which Mr. Adams was selected as Interim Chief Accounting Officer, and there are no family relationships between Mr. Adams and any director or executive officer of the Company.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits

 

Exhibit No.

   

Description

99.1    Press release issued by the Company on August 5, 2021
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)

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 hereunto duly authorized.

 

      ATHENEX, INC.
Date: August 5, 2021      

/s/ Randoll Sze

      Name:   Randoll Sze
      Title:     Chief Financial Officer
 EX-99.1 2 d37907dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

Athenex Provides Second Quarter 2021 Corporate and Financial Update

Updated investors on FDA Type A Meeting for oral paclitaxel

Klisyri® approved by the European Commission in July 2021

KUR-501 GD2 CAR-NKT Phase 1 data in neuroblastoma presented at ASGCT 2021

Abstract for oral paclitaxel + pembrolizumab Phase 1 combination study accepted for ESMO Congress 2021

Management to host conference call and webcast today at 8:00 a.m. ET

Buffalo, N.Y., August 5, 2021 (GLOBE NEWSWIRE) – Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today provided a corporate and financial update for the second quarter ended June 30, 2021.

“During the second quarter, we held a Type A meeting with the FDA to discuss the path forward for oral paclitaxel and encequidar in metastatic breast cancer and the deficiencies that were raised in the Complete Response Letter (CRL) we received in February,” said Johnson Lau, Chief Executive Officer of Athenex. “The FDA has indicated that a well-designed and well-conducted trial may adequately address these deficiencies. We are now evaluating the optimal design for a new clinical study which we plan to present to the FDA in the fourth quarter of 2021. We are continuing to advance oral paclitaxel in angiosarcoma towards registration.”

“Our acquisition of Kuur Therapeutics and its innovative allogeneic CAR-NKT technology was a strategically important development for Athenex and we believe it has the potential to unlock tremendous value,” continued Dr. Lau. “Kuur’s technology, combined with our TCR program, could propel us into a leadership position in cell therapy. We are pleased with the smooth integration of the Kuur team and operations to date and look forward to providing further updates as the programs advance.”

Second Quarter 2021 and Recent Business Highlights

Clinical Programs

Oral Paclitaxel and Encequidar

 

•  

Athenex held a Type A meeting with the US Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for oral paclitaxel in metastatic breast cancer during second quarter 2021. The Company is evaluating the optimal design for a new clinical study which it plans to present to the FDA in 4Q 2021.

 

•  

An abstract “Phase 1 Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of oral paclitaxel + encequidar in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies” has been accepted for e-Poster presentation at the European Society for Medical Oncology (ESMO) Congress 2021.

Cell Therapy

 

•  

Presented data from a Phase 1 study (GINAKIT2) of KUR-501 in neuroblastoma at the annual meeting of the American Society of Gene and Cell Therapy (ASGCT) 2021. The data showed one complete response and one partial response out of 11 evaluable and heavily pre-treated pediatric neuroblastoma patients. The therapy was well tolerated with only one Grade 2 CRS.

•  

Continued to enroll patients in a Phase 1 study (ANCHOR) evaluating KUR-502 in patients with relapsed/refractory CD19 positive malignancies including B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL).

 

•  

Received IRB approval to conduct a Phase 1 trial of TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 positive solid tumors).

Commercial Update

Klisyri® (tirbanibulin)

 

•  

Almirall, S.A. (BLM: ALM), Athenex’s partner, received marketing authorization of Klisyri® from the European Commission in July 2021 for the topical treatment of actinic keratosis (AK) on the face or scalp in adults. The approval followed receipt of a positive opinion from the CHMP of the European Medicines Agency in May 2021.

 

•  

Athenex entered into license agreements for tirbanibulin with Seqirus (a subsidiary of CSL Limited) and AVIR Pharma, expanding its international commercial partnerships for tirbanibulin in Australia and New Zealand, and Canada, respectively.

Specialty Pharmaceutical Business

 

•  

Athenex Pharmaceutical Division (APD) currently markets a total of 34 products with 61 SKUs.

 

•  

Athenex Pharma Solutions (APS) currently markets 4 products with 16 SKUs.

 

•  

503B operations at the Dunkirk Facility expected to commence in Q4 2021.

Corporate Update

 

•  

Athenex has accepted the resignation of its Chief Financial Officer, Randoll Sze, effective August 13, 2021. Mr. Steven Adams, the company’s current Corporate Controller, will take on the role of Interim Chief Accounting Officer until a permanent CFO is appointed.

Key Anticipated Milestones

 

•  

Plan to discuss the design of a new clinical study for oral paclitaxel in metastatic breast cancer with the FDA in Q4 2021

 

•  

Launch of Klisyri® in a major European market in 2H 2021

 

•  

Abstract on the ANCHOR Phase 1 study submitted to ASH 2021

 

•  

Phase 1 trial to evaluate TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 solid tumors) to initiate enrollment in 3Q 2021

 

•  

Results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 expected in 2022

Second Quarter 2021 Financial Highlights

Revenues from product sales decreased to $21.4 million for the three months ended June 30, 2021, from $40.2 million for the three months ended June 30, 2020, a decrease of $18.8 million or 47%. This decrease was attributable to a decline in APD product sales of $20.4 million primarily as the result of a decrease in demand for COVID-19 related drugs from the prior year, including some significant non-recurring orders of approximately $14.1 million. In addition, in the first half of 2021, we experienced significant COVID-related challenges in our Indian supply

chain and to a lesser extent in China. As a result, we were not able to receive some inventory from our partners located in these regions for a certain period of time. The Company also experienced a higher amount of product sales in 2020 as we started fulfilling demand for certain drugs used to treat patients hospitalized with COVID and demand for FDA shortage products. As a result, the product revenues in the second quarter of last year were particularly high, given the COVID pandemic had just started. Fluctuations in the infection rate and the spread of the global health pandemic and market demand may continue to significantly affect our product sales in the future. These were partially offset by an increase in 503B and contract manufacturing revenue of $1.5 million and $0.4 million, respectively.

License fees and other revenue increased by $0.5 million for the three months ended June 30, 2021. This increase was primarily due to $0.2 million grant revenue and $0.2 million in royalties received from Almirall for the sales of Klisyri® after the product launch in the U.S. in February 2021.

Cost of sales for the three months ended June 30, 2021 totaled $19.7 million, a decrease of $13.3 million, or 40%, as compared to $33.0 million for the three months ended June 30, 2020. The decrease was primarily due to a decrease of $13.1 million in cost of APD product sales, generally in-line with the decrease in the product sales revenue. Additionally, cost of sales related to royalties for license income decreased by $1.2 million from the royalty payment incurred in 2020 on the license revenue from Xiangxue. Cost of 503B product sales increased by $1.3 million as production levels increased.

R&D expenses for the three months ended June 30, 2021 totaled $21.1 million, a decrease of $0.9 million, or 4%, as compared to $22.0 million for the three months ended June 30, 2020. This was primarily due to a decrease in regulatory costs, clinical operations, and preclinical operations. The decrease in these items was partially offset by increases in oral paclitaxel and encequidar API costs in preparation for product launch, together with increases in drug licensing costs, R&D related compensation expenses, and costs related to 503B and cell therapy development.

SG&A expenses for the three months ended June 30, 2021 totaled $21.2 million, an increase of $3.7 million, or 21%, as compared to $17.5 million for the three months ended June 30, 2020. This was primarily due to increase in professional fees and other expenses related to the acquisition of Kuur, increases in compensation related costs, change in fair value of contingent consideration and operating costs including insurance costs and IT costs. These increases were partially offset by a decrease in costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and slowed upon receipt of the CRL in February 2021.

Interest expense totaled $5.7 million and $1.6 million for the three months ended June 30, 2021 and 2020, respectively. Interest expense in the current period was incurred from the Senior Credit Agreement with Oaktree, while interest expense in the prior period was primarily incurred from debt under a former credit agreement with Perceptive Advisors LLC and its affiliates.

Income tax benefit for the three months ended June 30, 2021 amounted to $11.0 million, compared to income tax expense of $0.1 million for the same period in 2020. The income tax benefit in the current year is primarily the result of taxable temporary difference due to the deferred tax liability recognized for the indefinite lived intangible assets acquired in connection with the acquisition of Kuur’s IPR&D. This taxable temporary difference is considered a source of taxable income to support the realization of deferred tax assets from the acquirer which resulted in a reversal of our valuation allowance.

Net loss attributable to Athenex for the three months ended June 30, 2021 was $34.3 million, or ($0.33) per diluted share, compared to a net loss of $40.5 million, or ($0.50) per diluted share, in the same period last year.

As of June 30, 2021, the Company had cash and cash equivalents of $76.9 million, restricted cash of $16.5 million, and short-term investments of $53.3 million.

For further details on the Company’s financial results, including the results for the six months ended June 30, 2021, refer to the Form 10Q to be filed with the SEC.

Financial Guidance

In terms of product sales guidance, the Company is limiting financial guidance to the existing Athenex product portfolio only. In 2020, the Company recorded a significant amount of revenues from international customers as a result of the global pandemic. However, it does not see these revenues as recurring in nature. The Company continues to expand its product portfolio. The Company is affirming the guidance it provided on May 6, 2021, as it currently expects its product sales in 2021, excluding any royalties from Klisyri®, to be in line with 2020 levels.

Cash Conservation Update

As of June 30, 2021, the Company had cash and cash equivalents, restricted cash and short-term investments of $146.7 million. Given uncertainty stemming from the CRL for oral paclitaxel, the Company identified and adopted certain cash conservation measures. Considering these initial measures, and based on our current operating plan, the Company now expects that its cash and cash equivalents, restricted cash and short-term investments as of June 30, 2021, will enable it to meet its current operational liquidity needs and fund operations into 4Q 2022.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Thursday, August 5, 2021, at 8:00 am Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

Domestic: (877) 407-0784

International: (201) 689-8560

Passcode: 13720461

The live conference call and replay can also be accessed by audio webcast here and also under “Events and Presentations” at the Investor Relations section of the Company’s website, located at https://ir.athenex.com.

About Athenex, Inc.

Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different technologies: (1), based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. For more information, please visit www.athenex.com.

Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to agree with the FDA on a new clinical study for oral paclitaxel that is capital and time efficient; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to our ability to successfully integrate the business of Kuur into our existing businesses, including uncertainties associated with maintaining relationships with customers, vendors and employees, as well as differences in operations, cultures, and management philosophies that may delay successful integration and our ability to support the added cost burden of Kuur’s business; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its ongoing impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facilities as well as our ability to find alternative sources of supply to meet our obligations and requirements; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.

Contacts

Investors:

Daniel Lang, MD

Athenex, Inc.

Email: danlang@athenex.com

Tim McCarthy

LifeSci Advisors, LLC

Email: tim@lifesciadvisors.com

ATHENEX, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

     June 30,     December 31,  
     2021     2020  
     (In thousands)  

Selected Balance sheet data:

     

Cash, cash equivalents, and restricted cash

    $ 93,441     $ 86,087  

Short-term investments

      53,283       138,636  

Goodwill

      69,216       38,891  

Working capital(1)

      150,168       229,820  

Total assets

      408,957       384,329  

Long-term debt

      149,996       148,587  

Total liabilities

      239,077       218,981  

Non-controlling interests

      (15,321 )      (14,427 ) 

Total stockholders’ equity

    $ 169,880     $ 165,348  

 

*

working capital: total current assets less total current liabilities

ATHENEX, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

(unaudited)

 

     Three months ended June 30,     Six months ended June 30,  
     2021     2020     2021     2020  
     (in thousands)     (in thousands)     (in thousands)     (in thousands)  

Revenue

         

Product sales, net

    $ 21,385     $ 40,167     $ 41,745     $ 58,714  

License and other revenue

      538       5       21,203       28,393  
  

 

 

    

 

 

    

 

 

    

 

 

  

Total revenue

      21,923       40,172       62,948       87,107  
  

 

 

    

 

 

    

 

 

    

 

 

  

Cost of sales

      (19,663 )      (33,006 )      (36,068 )      (52,578 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Gross profit

      2,260       7,166       26,880       34,529  
  

 

 

    

 

 

    

 

 

    

 

 

  

Research and development expenses

      (21,127 )      (22,015 )      (44,197 )      (39,207 ) 

Selling, general, and administrative expenses

      (21,231 )      (17,486 )      (43,351 )      (43,234 ) 

Interest income

      132       185       161       598  

Interest expense

      (5,684 )      (1,565 )      (10,592 )      (3,238 ) 

Loss on extinguishment of debt

      —         (7,230 )      —         (7,230 ) 

Income tax benefit (expense)

      11,035       (106 )      10,881       (2,987 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Net loss

      (34,615 )      (41,051 )      (60,218 )      (60,769 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Less: net loss attributable to non-controlling interests

      (341 )      (600 )      (894 )      (889 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Net loss attributable to Athenex, Inc.

    $ (34,274 )    $ (40,451 )    $ (59,324 )    $ (59,880 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted

    $ (0.33 )    $ (0.50 )    $ (0.60 )    $ (0.73 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Weighted-average shares used in computing net loss per share attributable to Athenex, Inc. common stockholders, basic and diluted

      103,370,268       81,564,441       98,427,561       81,551,995  
  

 

 

    

 

 

    

 

 

    

 

 

  
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