ADC Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Updates
ADC Therapeutics reported ZYNLONTA® net sales of $17.0 million for Q4 2021 and $33.9 million for FY 2021 following its May launch. The LOTIS-5 Phase 3 trial combining ZYNLONTA with rituximab has completed its safety lead-in and is now enrolling randomized participants. The company plans to discontinue the LOTIS-3 trial while focusing on the second-line opportunity for ZYNLONTA. R&D expenses dropped to $42.5 million for Q4, whereas net loss was $34.4 million for the quarter, improving from last year. The company aims to expand ZYNLONTA's availability and advance its clinical pipeline in 2022.
- ZYNLONTA generated net sales of $33.9 million in FY 2021 after its launch.
- The LOTIS-5 trial is advancing with no new safety events, supporting the potential for a supplemental BLA.
- Cash and cash equivalents increased to $466.5 million as of December 31, 2021.
- Net loss was $34.4 million for Q4 2021 and $230.0 million for FY 2021.
- R&D expenses increased to $158.0 million for FY 2021, driven by investments in expanding the clinical portfolio.
- Discontinuation of the LOTIS-3 trial may impact future revenue potential.
ZYNLONTA® (loncastuximab tesirine-lpyl) net sales of
Company to host conference call today at
LAUSANNE,
“We are encouraged by the progress of the ZYNLONTA® launch and pleased with its differentiated product profile across the third-line patient spectrum, including patients with hard-to-treat disease, such as double hit/triple hit genetics, primary refractory and post CAR-T. In addition, data from our combination studies suggest that ZYNLONTA may be a valuable combination agent in earlier lines of therapy,” said
Recent Highlights and Developments
ZYNLONTA (loncastuximab tesirine-lpyl)
-
ZYNLONTA generated net sales of
in the fourth quarter of 2021 and$17.0 million in 2021 following the May launch.$33.9 million -
The Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in second-line transplant-ineligible DLBCL patients (
LOTIS-5 ) has cleared the safety lead-in and is now enrolling the randomized portion of the study. The combination of ZYNLONTA and rituximab is well tolerated, there are no new safety events, and the initial data suggest the agents are additive. The Company looks forward to sharing these data at a future meeting and believes this trial will support a supplemental Biologics License Application (BLA) in second-line transplant-ineligible patients. -
The Company will focus on the second-line opportunity with the combination of ZYNLONTA and rituximab as the fastest potential route to a label in second-line therapy for DLBCL and will discontinue the Phase
2 LOTIS-3 trial of ZYNLONTA in combination with ibrutinib in third-line DLBCL and MCL. -
In first-line DLBCL, the Company plans to initiate enrollment in the second half of 2022 for the
LOTIS-9 study of ZYNLONTA in combination with rituximab in first-line unfit or frail DLBCL patients who are not eligible for R-CHOP. This is an important and meaningful subset of first-line patients. These patients have a significant unmet need, and the Company believes the ZYNLONTA profile combined with rituximab provides a potential advantage. -
The Company intends to initiate the
LOTIS-7 trial in the first half of 2022 to study ZYNLONTA in multiple additional combinations. Based on the plans to advanceLOTIS-9 in unfit or frail first-line patients andLOTIS-7 for novel combinations, the Company will not pursue theLOTIS-8 dose-finding trial of ZYNLONTA in combination with R-CHOP in first-line DLBCL. -
The comparator agent in the Phase
2 LOTIS-6 study, idelalisib, was recently withdrawn from the follicular lymphoma market. As such, the Company has voluntarily paused the study and will consult with its clinical advisors and theU.S. Food and Drug Administration (FDA) on the optimal path forward.
Cami (camidanlumab tesirine)
- The 12-month patient follow-up in the pivotal Phase 2 trial of Cami in Hodgkin lymphoma has completed. The Company has submitted the data in an abstract for an upcoming oncology conference and plans to meet with the FDA for a pre-BLA filing meeting.
- The Phase 1b solid tumor trial of Cami in combination with pembrolizumab continues to dose escalate and in parallel has initiated a dose expansion cohort.
ADCT-601 (Targeting AXL)
-
The Company plans to initiate the Phase 1b study of ADCT-601 in solid tumors in the first half of 2022. In
January 2022 , results of a preclinical study that aimed to validate the mode of action and evaluate the efficacy of ADCT-601 in vitro and in vivo were published in Molecular Cancer Therapeutics. The study showed that ADCT-601, targeting AXL, had potent and durable antitumor activity.
ADCT-212 (Targeting PSMA)
-
In
February 2022 , the Company disclosed a new preclinical program, ADCT-212, a second-generation ADC targeting prostate specific membrane antigen (PSMA), a validated target over-expressed in the majority of metastatic castration-resistant prostate cancer. The Company is completing preclinical studies to support an Investigational New Drug (IND) filing for ADCT-212.
Other Solid Tumor Programs
-
In
February 2022 , the Company held a solid tumor pipeline webcast highlighting its ADC platform and five solid tumor programs in clinical and preclinical development.
Corporate Update
Geographic Expansion:
-
In
October 2021 , the Company received validation of its Marketing Authorization Application (MAA) from theEuropean Medicines Agency (EMA). -
In
January 2022 , the Company entered into an exclusive license agreement withMitsubishi Tanabe Pharma Corporation to develop and commercialize ZYNLONTA inJapan . The Company received an upfront payment of and is eligible to receive up to an additional$30 million in milestones if certain development and commercial events are achieved. The Company will also receive royalties ranging in percentage from the high teens to the low twenties based on net sales of the product in$205 million Japan .
Upcoming Expected Milestones
Hematology Franchise
ZYNLONTA
-
Continue to enroll the randomized portion of the
LOTIS-5 confirmatory trial in combination with rituximab -
Initiate the
LOTIS-9 trial of ZYNLONTA + rituximab in 1L unfit/frail DLBCL patients in 2H 2022 -
Initiate the
LOTIS-7 trial of ZYNLONTA in multiple combinations in NHL in 1H 2022 -
Overland ADCT BioPharma continues enrollment in the pivotal Phase 2 trial in
China of ZYNLONTA in r/r DLBCL
Cami
- Report topline results for the Phase 2 trial in HL in 1H 2022
- Meet with FDA for pre-BLA meeting in 2H 2022
ADCT-602 (targeting CD22)
- Continue to enroll the Phase 1 trial in acute lymphoblastic leukemia (ALL)
Solid Tumor Franchise
Cami (targeting CD25)
- Continue to advance the Phase 1b solid tumor trial of Cami in combination with pembrolizumab
ADCT-901 (targeting KAAG1)
- Continue to enroll the Phase 1 study in multiple solid tumors
ADCT-601 (targeting AXL)
- Initiate the Phase 1b combination study in multiple solid tumors in 1H 2022
ADCT-701 (targeting DLK1)
- Continue to work with the NCI for completion of preclinical studies to support an IND filing
ADCT-212 (targeting PSMA)
- Continue completion of preclinical studies to support an IND filing
Fourth Quarter and Full Year 2021 Financial Results
Product Revenue
Product revenue (net) was
Cash and Cash Equivalents
Cash and cash equivalents were
Research and Development (R&D) Expenses
R&D expenses were
Selling and Marketing (S&M) Expenses
S&M expenses were
G&A Expenses
G&A expenses were
Income Tax Benefit (Expense)
The Company recorded an income tax benefit of
Net Loss and Adjusted Net Loss
Net loss was
In addition to the items noted above, net loss for the quarter and year ended
Adjusted net loss was
Conference Call Details
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
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’ 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,
ZYNLONTA® is a registered trademark of
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:
- Adjusted net loss
- Adjusted net loss per share
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 may occur occasionally and are not normal, recurring operating expenses, cash or non-cash, 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 and generally represent items that, either as a result of their nature or significance, management would not anticipate occurring as part of our normal business on a regular basis. 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, the gain recognized in connection with the receipt of the
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 for the three- and twelve-month periods ended
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, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, planned commercialization activities, research and development costs, 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
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||||||||
Condensed Consolidated Statement of Operations (Unaudited) |
||||||||
(in KUSD except for share and per share data) |
||||||||
For the Three Months Ended
|
|
For the Twelve Months Ended
|
||||||
2021 |
|
2020 |
|
2021 |
|
2020 |
||
Product revenues, net | 17,010 |
- |
33,917 |
- |
||||
Cost of product sales | (770) |
- |
(1,393) |
- |
||||
Research and development expenses | (42,492) |
(48,552) |
(158,002) |
(142,032) |
||||
Selling and marketing expenses | (18,603) |
(9,353) |
(64,780) |
(22,101) |
||||
General and administrative expenses | (17,926) |
(20,096) |
(71,462) |
(55,130) |
||||
Total operating expense | (79,791) |
(78,001) |
(295,637) |
(219,263) |
||||
Loss from operations | (62,781) |
(78,001) |
(261,720) |
(219,263) |
||||
Financial expense | (9,520) |
(2,047) |
(18,340) |
(4,926) |
||||
Financial income | 20 |
100 |
66 |
832 |
||||
Non-operating income (expense) | 15,929 |
24,145 |
28,489 |
(22,606) |
||||
Total other income (expense) | 6,429 |
22,198 |
10,215 |
(26,700) |
||||
Loss before taxes | (56,352) |
(55,803) |
(251,505) |
(245,963) |
||||
Income tax benefit (expense) | 21,971 |
(126) |
21,479 |
(327) |
||||
Net loss | (34,381) |
(55,929) |
(230,026) |
(246,290) |
||||
Net loss attributable to: | ||||||||
Owners of the parent | (34,381) |
(55,929) |
(230,026) |
(246,290) |
||||
Loss per share | ||||||||
Basic and diluted loss per share (in USD) | (0.45) |
(0.73) |
(3.00) |
(3.77) |
|
|||
Condensed Consolidated Balance Sheet (Unaudited) |
|||
(in KUSD) |
|||
ASSETS | |||
Current assets | |||
Cash and cash equivalents | 466,544 |
439,195 |
|
Accounts receivable, net | 30,218 |
- |
|
Inventory | 11,122 |
- |
|
Other current assets | 17,298 |
11,255 |
|
Total current assets | 525,182 |
450,450 |
|
Non-current assets | |||
Property, plant and equipment | 4,066 |
1,629 |
|
Right-of-use assets | 7,164 |
3,129 |
|
Intangible assets | 13,582 |
10,179 |
|
Interest in joint venture | 41,236 |
47,908 |
|
Deferred tax asset | 26,049 |
- |
|
Other long-term assets | 693 |
397 |
|
Total non-current assets | 92,790 |
63,242 |
|
Total assets | 617,972 |
513,692 |
|
LIABILITIES AND EQUITY | |||
Current liabilities | |||
Accounts payable | 12,080 |
5,279 |
|
Other current liabilities | 50,497 |
30,375 |
|
Lease liabilities, short-term | 1,029 |
1,002 |
|
Current income tax payable | 3,754 |
149 |
|
Convertible loans, short-term | 6,575 |
3,631 |
|
Total current liabilities | 73,935 |
40,436 |
|
Non-current liabilities | |||
Convertible loans, long-term | 87,153 |
34,775 |
|
Convertible loans, derivatives | 37,947 |
73,208 |
|
Deferred royalty obligation, long-term | 218,664 |
- |
|
Deferred gain of joint venture | 23,539 |
23,539 |
|
Lease liabilities, long-term | 6,994 |
2,465 |
|
Defined benefit pension liabilities | 3,652 |
3,543 |
|
Other non-current liabilities | - |
221 |
|
Total non-current liabilities | 377,949 |
137,751 |
|
Total liabilities | 451,884 |
178,187 |
|
Equity attributable to owners of the parent | |||
Share capital | 6,445 |
6,314 |
|
Share premium | 981,827 |
981,056 |
|
(128) |
(4) |
||
Other reserves | 102,646 |
42,753 |
|
Cumulative translation adjustments | 183 |
245 |
|
Accumulated losses | (924,885) |
(694,859) |
|
Total equity attributable to owners of the parent | 166,088 |
335,505 |
|
Total liabilities and equity | 617,972 |
513,692 |
|
|||||||
Reconciliation of IFRS Measures to Non-IFRS Measures (Unaudited) |
|||||||
(in KUSD except for share and per share data) |
|||||||
Three Months Ended |
|
Twelve Months Ended |
|||||
in KUSD (except for share and per share data) | 2021 |
|
2020 |
|
2021 |
|
2020 |
Net loss | (34,381) |
(55,929) |
(230,026) |
(246,290) |
|||
Adjustments: | |||||||
Share-based compensation expense (i) | 13,539 |
15,416 |
60,555 |
42,928 |
|||
Convertible loans, derivatives, change in fair value (income) expense (ii) | (18,614) |
18 |
(34,893) |
45,411 |
|||
Convertible loans, first and second tranche, derivative, transaction costs (iii) | - |
- |
148 |
1,571 |
|||
Effective interest expense on convertible loans (iv) | 3,025 |
1,975 |
10,418 |
4,756 |
|||
Deferred royalty obligation financial expense and cumulative catch-up adjustment (v) | 6,442 |
- |
7,688 |
- |
|||
Gain on intellectual property contributed to joint venture (vi) | - |
(24,501) |
- |
(24,501) |
|||
Adjusted net loss | (29,989) |
(63,021) |
(186,110) |
(176,125) |
|||
Net loss per share, basic and diluted | (0.45) |
(0.73) |
(3.00) |
(3.77) |
|||
Adjustment to net loss per share, basic and diluted | 0.06 |
(0.09) |
0.58 |
1.08 |
|||
Adjusted net loss per share, basic and diluted | (0.39) |
(0.82) |
(2.42) |
(2.69) |
|||
Weighted average shares outstanding, basic and diluted | 76,801,875 |
76,719,090 |
76,748,204 |
65,410,292 |
(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. 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 as well as the gain recognized in connection with the receipt of the |
|
(iii) |
The transaction costs allocated to the convertible loan first and second tranche derivatives 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. |
|
|
|
|
(v) |
Deferred royalty obligation financial 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, respectively. |
|
|
|
|
(vi) |
Gain related to the Company’s contribution of intellectual property for its equity interest in the Overland ADCT BioPharma joint venture. This accounting entry had no cash impact. |
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Investors
Eugenia.Litz@adctherapeutics.com
+44 7879 627205
amanda.hamilton@adctherapeutics.com
+1 917-288-7023
maryann.ondish@adctherapeutics.com
+1 914-552-4625
EU Media
amu@dynamicsgroup.ch
+41 (0) 43 268 3231
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FAQ
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