Le Lézard
Classified in: Health, Science and technology, Business
Subjects: EARNINGS, Conference Call, Webcast, Business Update

ADC Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Updates


ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the second quarter ended June 30, 2022 and provided business updates.

"The ZYNLONTA® launch is advancing steadily as we continue to increase awareness and advocacy. There is significant opportunity ahead and we have a focused plan in place to achieve continued growth in the coming quarters," commented Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Our pipeline of hematology and solid tumor programs is progressing well with impressive Cami Phase 2 data in Hodgkin lymphoma presented at the EHA Congress in June. Our recent license agreement with Sobi® in Europe gives us worldwide access for ZYNLONTA. We have a strong cash runway extending into early 2025 which makes us well-positioned to execute on our key objectives."

Recent Highlights and Developments

Corporate Update

Hematology Franchise

ZYNLONTA (loncastuximab tesirine-lpyl)

Cami (camidanlumab tesirine) in Hodgkin lymphoma

Solid Tumor Franchise

ADCT-601 (targeting AXL)

Upcoming Expected Milestones

Hematology Franchise

ZYNLONTA

Cami

Solid Tumor Franchise

Cami (targeting CD25)

ADCT-901 (targeting KAAG1)

Second Quarter Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $376.8 million as of June 30, 2022, compared to $466.5 million as of December 31, 2021.

Product Revenue

Product revenue (net) was $17.3 million for the quarter, compared to $3.8 million for the same quarter in 2021. Net revenues are for U.S. sales of ZYNLONTA, which received accelerated approval from the FDA on April 23, 2021.

Cost of product sales

Cost of product sales was $2.3 million for the quarter, compared to $0.1 million for the same quarter in 2021, an increase of $2.1 million associated with $1.9 million of impairment charges primarily related to the manufacturing of antibodies that was not within the Company's specifications. The specification issues did not, and are not expected to, impact the Company's ability to supply commercial product. In addition, cost of product sales increased due to a full second quarter of sales activity in 2022 as compared to the same period in 2021 due to the commencement of ZYNLONTA sales in May 2021.

Research and Development (R&D) Expenses

R&D expenses were $48.5 million for the quarter ended June 30, 2022, compared to $39.5 million for the same quarter in 2021. As a result of FDA approval of ZYNLONTA in April 2021, the Company reversed $6.8 million of previously recorded impairment charges during the three months ended June 30, 2021, relating to inventory costs incurred for the manufacture of product prior to FDA approval. In addition, R&D expenses increased due to clinical activities to expand ZYNLONTA's potential market opportunities in earlier lines of therapy and advance the Company's portfolio of solid tumor programs.

Selling and Marketing (S&M) Expenses

S&M expenses were $17.7 million for the quarter ended June 30, 2022, as compared to $15.2 million for the same quarter in 2021. The increase in S&M expenses is related to the ongoing launch of ZYNLONTA.

G&A Expenses

G&A expenses were $18.2 million for the quarter ended June 30, 2022, compared to $19.4 million for the same quarter in 2021. G&A expenses decreased primarily due to lower share-based compensation expense.

Net Loss and Adjusted Net Loss

Net loss was $64.4 million, or a net loss of $0.84 per basic and diluted share, for the quarter ended June 30, 2022. This compares to a net loss of $72.6 million, or a net loss of $0.95 per basic and diluted share, for the same quarter in 2021. The decrease in net loss for the quarter ended June 30, 2022, as compared to the same period in 2021, was primarily due to higher product revenue, partially offset by the increase in cost of product sales, R&D and S&M expenses. In addition, net loss decreased for the second quarter of 2022 as a result of income arising from changes in the fair value of derivatives associated with our Deerfield Facility Agreement, partially offset by higher interest expense associated with the deferred obligation with Healthcare Royalty Partners.

Adjusted net loss was $56.3 million, or an adjusted net loss of $0.73 per basic and diluted share, for the quarter ended June 30, 2022. This compares to $53.7 million, or an adjusted net loss of $0.70 per basic and diluted share, for the same quarter in 2021.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss second quarter 2022 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at www.ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

About ZYNLONTA® (loncastuximab tesirine-lpyl)

ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

About ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large b-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a pivotal Phase 2 trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

ZYNLONTA® is a registered trademark of ADC Therapeutics SA.

Use of Non-IFRS Financial Measures

In addition to financial information prepared in accordance with IFRS, this document also contains certain non-IFRS financial measures based on management's view of performance including:

Management uses such measures internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic decisions regarding the allocation of capital. We believe that these adjusted financial measures provide useful information to investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate operating performance comparability across both past and future reporting periods. These non-IFRS measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with IFRS. When preparing these supplemental non-IFRS measures, management typically excludes certain IFRS items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these IFRS items to be normal, recurring cash operating expenses; however, these items may not meet the IFRS definition of unusual or non-recurring items. Since non-IFRS financial measures do not have standardized definitions and meanings, they may differ from the non-IFRS financial measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other IFRS financial measures.

The following items are excluded from adjusted net loss and adjusted net loss per share:

Shared-Based Compensation Expense: We exclude share-based compensation expense from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation expense has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy.

Certain Other Items: We exclude certain other significant items that we believe do not represent the performance of our business, from our adjusted financial measures. Such items are evaluated by management on an individual basis based on both quantitative and qualitative aspects of their nature. While not all-inclusive, examples of certain other significant items excluded from our adjusted financial measures would be: changes in the fair value of derivatives and the effective interest expense associated with the Facility Agreement with Deerfield, transaction costs associated with debt or equity issuances that are expenses pursuant to IFRS, and the effective interest expense and a cumulative catch-up adjustment associated with the deferred royalty obligation under the royalty purchase agreement with HealthCare Royalty Partners.

See the attached Reconciliation of IFRS Measures to Non-IFRS Measures for explanations of the amounts excluded and included to arrive at the non-IFRS financial measures.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business and commercialization strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, projected revenues and expenses and the timing of revenues and expenses, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

ADC Therapeutics SA
Condensed Consolidated Interim Statement of Operations (Unaudited)
(in KUSD except for share and per share data)
       
  For the Three Months Ended
June 30,
  For the Six Months Ended
June 30,
 

2022

 

2021

 

2022

 

2021

Product revenues, net

           17,291

 

                  3,760

 

                33,789

 

           3,760

License revenue

                  -  

 

                       -  

 

                30,000

 

                -  

Total revenue

           17,291

 

                  3,760

 

                63,789

 

           3,760

               
Operating expense              
Cost of product sales

            (2,266)

 

                   (121)

 

                (2,795)

 

            (121)

Research and development expenses

          (48,537)

 

               (39,533)

 

              (97,489)

 

        (78,705)

Selling and marketing expenses

          (17,659)

 

               (15,221)

 

              (36,029)

 

        (29,132)

General and administrative expenses

          (18,240)

 

               (19,367)

 

              (37,251)

 

        (36,949)

Total operating expense

          (86,702)

 

               (74,242)

 

            (173,564)

 

      (144,907)

Loss from operations

          (69,411)

 

               (70,482)

 

            (109,775)

 

      (141,147)

               
Other income (expense)              
Financial income

                  16

 

                       15

 

                18,324

 

               30

Financial expense

            (8,801)

 

                 (2,555)

 

              (18,018)

 

         (4,555)

Non-operating income (expense)

           12,875

 

                     693

 

                26,317

 

         21,923

Total other income (expense)

             4,090

 

                 (1,847)

 

                26,623

 

         17,398

Loss before taxes

          (65,321)

 

               (72,329)

 

              (83,152)

 

      (123,749)

Income tax benefit (expense) 

                947

 

                   (240)

 

                 2,117

 

            (347)

Net loss

          (64,374)

 

               (72,569)

 

              (81,035)

 

      (124,096)

               
Net loss attributable to:              
Owners of the parent

          (64,374)

 

               (72,569)

 

              (81,035)

 

      (124,096)

               
Net loss per share, basic and diluted

              (0.84)

 

                  (0.95)

 

                  (1.05)

 

           (1.62)

ADC Therapeutics SA
Condensed Consolidated Interim Balance Sheet (Unaudited)
(in KUSD)
   
  June 30,
2022
  December 31,
2021
ASSETS      
Current assets      
Cash and cash equivalents

               376,778

 

                           466,544

Accounts receivable, net

                 20,863

 

                             30,218

Inventory

                 14,650

 

                             11,122

Other current assets

                 12,151

 

                             17,298

Total current assets

               424,442

 

                           525,182

Non-current assets      
Property, plant and equipment

                  3,596

 

                               4,066

Right-of-use assets

                  6,094

 

                               7,164

Intangible assets

                 14,575

 

                             13,582

Interest in joint venture

                 36,817

 

                             41,236

Deferred tax asset

                 34,040

 

                             26,049

Other long-term assets

                     899

 

                                 693

Total non-current assets

                 96,021

 

                             92,790

       
Total assets

               520,463

 

                           617,972

       
LIABILITIES AND SHAREHOLDERS' EQUITY      
Current liabilities      
Accounts payable

                 13,019

 

                             12,080

Other current liabilities

                 52,384

 

                             50,497

Lease liabilities, short-term

                     909

 

                               1,029

Current income tax payable

                     799

 

                               3,754

Convertible loans, short-term

                  6,573

 

                               6,575

Total current liabilities

                 73,684

 

                             73,935

Non-current liabilities      
Convertible loans, long-term

                 89,844

 

                             87,153

Convertible loans, derivatives

                  7,637

 

                             37,947

Deferred royalty obligation, long-term

               204,423

 

                           218,664

Deferred gain of joint venture

                 23,539

 

                             23,539

Lease liabilities, long-term

                  5,990

 

                               6,994

Defined benefit pension liabilities

                       -  

 

                               3,652

Total non-current liabilities

               331,433

 

                           377,949

       
Total liabilities

               405,117

 

                           451,884

       
Equity attributable to owners of the parent      
Share capital

                  6,445

 

                               6,445

Share premium

               981,818

 

                           981,827

Treasury shares

                    (119)

 

                                (128)

Other reserves

               133,480

 

                           102,646

Cumulative translation adjustments

                    (358)

 

                                 183

Accumulated losses

           (1,005,920)

 

                          (924,885)

Total equity attributable to owners of the parent

               115,346

 

                           166,088

   
Total liabilities and equity

               520,463

 

                           617,972

ADC Therapeutics SA
Reconciliation of IFRS Measures to Non-IFRS Measures (Unaudited)
(in KUSD except for share and per share data)
     
 

    Three Months Ended June 30,     

 

      Six Months Ended June 30,

in KUSD (except for share and per share data)

2022

 

2021

 

2022

 

2021

Net loss

         (64,374)

 

         (72,569)

 

       (81,035)

 

      (124,096)

Adjustments:    
Share-based compensation expense (i)

          13,818

 

          18,267

 

        27,728

 

         32,218

Convertible loans, derivatives, change in fair value income (ii)

         (14,455)

          (2,053)

 

       (30,310)

 

        (23,222)

Convertible loans, first and second tranche, derivatives, transaction costs (iii)

                 -  

 

               148

 

               -  

 

              148

Effective interest expense on convertible loans (iv)

            3,126

            2,450

 

          6,148

 

           4,432

Deferred royalty obligation interest expense (v)

            5,545

 

                 -  

 

        11,687

 

                -  

Deferred royalty obligation cumulative catch-up adjustment income (v)

                 -  

                 -  

 

       (18,288)

 

                -  

Adjusted net loss

         (56,340)

 

         (53,757)

 

       (84,070)

 

      (110,520)

               
Net loss per share, basic and diluted

            (0.84)

 

            (0.95)

 

           (1.05)

 

           (1.62)

Adjustment to net loss per share, basic and diluted

               0.11

 

               0.25

 

           (0.04)

 

              0.18

Adjusted net loss per share, basic and diluted

            (0.73)

 

            (0.70)

 

           (1.09)

 

           (1.44)

Weighted average shares outstanding, basic and diluted

    76,911,713

 

    76,728,714

 

  76,866,968

 

   76,725,210

(i)

Share-based compensation expense represents the cost of equity awards issued to our directors, management and employees. The fair value of awards is computed at the time the award is granted, including any market and other performance conditions, and is recognized over the vesting period of the award by a charge to the income statement and a corresponding increase in other reserves within equity. See note 15, "Share-based compensation" to the unaudited condensed consolidated interim financial statements. These accounting entries have no cash impact.

 

 

(ii)

Change in the fair value of the convertible loan derivatives results from the valuation at the end of each accounting period of the derivatives associated with the convertible loans. See note 14, "Convertible loans" to the unaudited condensed consolidated interim financial statements. There are several inputs to these valuations, but those most likely to result in significant changes to the valuations are changes in the value of the underlying instrument (i.e., changes in the price of our common shares) and changes in expected volatility in that price. These accounting entries have no cash impact.

 

 

(iii)

The transaction costs allocated to the convertible loan first and second tranche derivative represent actual costs. These are not expected to recur on an ongoing basis.

 

 

(iv)

Effective interest expense on convertible loans relates to the increase in the value of our convertible loans in accordance with the effective interest method. See note 14, "Convertible loans" to the unaudited condensed consolidated interim financial statements.

 

 

(v)

Deferred royalty obligation interest expense and cumulative catch-up adjustment relates to the accretion expense on our deferred royalty obligation pursuant to the royalty purchase agreement with HCR and changes in the expected payments to HCR based on a periodic assessment of our underlying revenue projections. See note 16, "Deferred royalty obligation" to the unaudited condensed consolidated interim financial statements. 

 


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