ADC Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates
ADC Therapeutics reported Q4 2022 net sales of $19.8 million for ZYNLONTA, a 16.5% increase year-over-year, and $74.9 million for the full year 2022. The company anticipates double-digit growth in net sales for FY 2023, with a potential revenue increase of $500 million to $1 billion in the future.
The cash runway is expected to extend into mid-2025. The company also announced milestones for pipeline developments and new leadership appointments. Net loss improved to $24.2 million in Q4 2022, a reduction from $34.4 million in Q4 2021, attributed to higher revenues and reduced operating expenses.
- Q4 net sales of ZYNLONTA increased by 16.5% year-over-year.
- Revenue potential for ZYNLONTA projected at $500 million to $1 billion in the future.
- Expected growth in FY 2023 net sales by a double-digit percentage.
- Improved net loss of $24.2 million in Q4 2022 from $34.4 million in Q4 2021.
- Sequential decline in Q4 net sales by 7.0% compared to Q3 2022.
ZYNLONTA® (loncastuximab tesirine-lpyl) net sales of
FY 2023 ZYNLONTA net sales expected to grow by a double-digit percentage year-over-year
Multiple data catalysts expected in the next 12 to 18 months supported by cash runway expected into mid-2025
Company to host conference call today at
LAUSANNE,
“We made good progress across the business in 2022, including laying the crucial groundwork for the ongoing ZYNLONTA launch. This year, we expect to grow ZYNLONTA net product sales by a double-digit percentage year-over-year. Beyond the 3L+ setting, ZYNLONTA’s differentiated product profile positions it as an attractive combination partner in earlier lines of therapy. This potential is actively being explored in numerous company-sponsored and independent trials, which, if successful, will help serve patients with unmet medical needs and could increase ZYNLONTA’s annual revenue potential to a range of
“I believe our strengthened senior leadership team with substantial commercial and drug development experience will be critical in our transition to the next phase of growth and unlocking the tremendous value of the Company over time. Supported by a cash runway that is expected to extend into mid-2025, we believe we are well-positioned to execute our strategic imperatives in 2023 and beyond.”
Recent Highlights and Developments
ZYNLONTA (loncastuximab tesirine-lpyl)
-
Revenue from the net sales of ZYNLONTA in the fourth quarter of 2022 increased to
, a$19.8 million 16.5% increase over the same quarter in 2021, and for the full year 2022, partially offset by higher gross-to-net sales deductions. The sequential third quarter to fourth quarter slight decline of$74.9 million 7.0% in net sales was due to higher gross-to-net and individual ordering account fluctuations. -
The
European Commission (EC) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for the use of ZYNLONTA (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). -
The Company entered into a collaboration and clinical supply agreement with Roche to evaluate ZYNLONTA in combination with glofitamab and mosunetuzumab in addition to polatuzumab in the Phase
1 LOTIS-7 trial.
Cami (camidanlumab tesirine)
- Based on the positive pivotal Phase 2 data, the Company is actively seeking a partner to progress this program.
Pipeline
- ADCT-901 (targeting KAAG1): Dose escalation in the Phase 1 single-agent trial is progressing. The Company is amending the protocol to explore different dosing schedules to optimize the potential clinical outcomes for patients and in preparation for regulatory interactions.
- ADCT-601 (targeting AXL): Dose escalation in the Phase 1b trial is progressing and the IHC assay is under final validation. The study is comprised of a monotherapy arm including patients with sarcoma, non-small cell lung cancer and those with AXL gene amplification and a combination arm with gemcitabine in patients with sarcoma.
-
ADCT-602 (targeting CD22): Initial data showing encouraging clinical activity from the Phase 1 study of ADCT-602 for patients with relapsed or refractory acute lymphoblastic leukemia were released in an oral presentation at the 64th
American Society of Hematology (ASH) Annual Meeting byThe University of Texas MD Anderson Cancer Center .
Corporate Update
-
Mohamed Zaki , MD, PhD, was appointed the Company’s new Chief Medical Officer (CMO), effectiveJanuary 3, 2023 .Dr. Zaki is a pharmaceutical industry veteran with over 20 years of experience in oncology and hematology drug development. Most recently, he served as Vice President & Global Head ofOncology Development at AbbVie.Dr. Zaki worked on ibrutinib, venetoclax, lenalidomide and pomalidomide, among many other notable therapies. -
Jose “Pepe” Carmona was appointed the Company’s new Chief Financial Officer (CFO), effective
December 19, 2022 .Mr. Carmona is a seasoned CFO with over 20 years of financial leadership optimizing capital formation, developing and implementing capital allocation strategies, managing multibillion-dollar international commercial businesses and executing partnerships in the pharmaceutical and biotech industry, both in theU.S. and internationally.
Guidance
The Company has set the following guidance based on its current business plan:
-
Expected to grow ZYNLONTA FY 2023 net product sales by a double-digit percentage year-over-year. This includes a gross-to-net increase as compared to 2022 of:
- Approximately 2 to 3 percentage points related to Group Purchasing Organization (GPO) contracting
-
Mid- to high-single-digit percentage points resulting from the
Infrastructure Investment and Jobs Act’s requirement for manufacturers of certain single-source drugs separately paid for under Medicare Part B and marketed in single-dose containers to provide annual refunds for unused drug, effectiveJanuary 1, 2023
- Anticipated decrease in total operating expenses in 2023 and 2024 as compared to 2022
- Expected cash runway extended into the middle of 2025
Upcoming Expected Milestones
ZYNLONTA
- Grow ZYNLONTA net sales by a double-digit percentage year-over-year and achieve commercial brand profitability in 2023
- European phased launch by partner Sobi in 2Q 2023
-
Complete enrollment of the
LOTIS-5 study in 2024 -
Preliminary safety and efficacy data from the
LOTIS-9 study in 2024 -
Preliminary safety and efficacy data from the
LOTIS-7 study in 2024
Pipeline
ADCT-901 (targeting KAAG1)
- Preliminary data from Phase 1 dose escalation study in 1H 2024
ADCT-601 (targeting AXL)
- Preliminary data from Phase 1 dose escalation/expansion study in 1H 2024
ADCT-212 (targeting PSMA)
- Initiate Phase 1 study in 1H 2024
ADCT-602 (targeting CD22)
- Complete Phase 1 dose expansion study in 1H 2024
ADCT-701 (targeting DLK-1)
- Initiate Phase 1 study in 2H 2023
Fourth Quarter and Full Year Financial Results
Cash and Cash Equivalents
Cash and cash equivalents were
Product Revenue
Net product revenue was
License Revenue
License revenue was
Cost of Product Sales
Cost of product sales was
Research and Development (R&D) Expenses
R&D expenses were
Selling and Marketing (S&M) Expenses
S&M expenses were
General and Administrative (G&A) Expenses
G&A expenses were
Net Loss and Adjusted Net Loss
Net loss was
Adjusted net loss, which is a non-IFRS financial measure, was
The decrease in net loss and adjusted net loss for the quarter and year ended
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. In addition to ZYNLONTA,
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 and income
- Adjusted net loss and income 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 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 warrant obligations and the effective interest expense associated with the Facility Agreement with
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 forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the Company’s ability to achieve the 2023 net product sales guidance for ZYNLONTA® and the decrease in total operating expenses for 2023 and 2024, the expected cash runway into the middle of 2025, the Company’s ability to continue to commercialize ZYNLONTA® in
Condensed Consolidated Statement of Operations (Unaudited) (in KUSD except for per share data) |
||||||||
|
|
For the Three Months Ended
|
|
For the Years Ended
|
||||
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Product revenues, net |
|
19,798 |
|
17,010 |
|
74,908 |
|
33,917 |
License revenue |
|
50,000 |
|
— |
|
135,000 |
|
— |
Total revenue |
|
69,798 |
|
17,010 |
|
209,908 |
|
33,917 |
|
|
|
|
|
|
|
|
|
Operating expense |
|
|
|
|
|
|
|
|
Cost of product sales |
|
(489) |
|
(770) |
|
(4,579) |
|
(1,393) |
Research and development expenses |
|
(48,733) |
|
(42,492) |
|
(187,898) |
|
(158,002) |
Selling and marketing expenses |
|
(16,176) |
|
(18,603) |
|
(69,052) |
|
(64,780) |
General and administrative expenses |
|
(15,138) |
|
(17,926) |
|
(72,006) |
|
(71,462) |
Total operating expense |
|
(80,536) |
|
(79,791) |
|
(333,535) |
|
(295,637) |
Loss from operations |
|
(10,738) |
|
(62,781) |
|
(123,627) |
|
(261,720) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Financial income |
|
1,627 |
|
20 |
|
17,970 |
|
66 |
Financial expense |
|
(9,804) |
|
(9,520) |
|
(36,924) |
|
(18,340) |
Non-operating (expense) income |
|
(1,275) |
|
15,929 |
|
(12,080) |
|
28,489 |
Total other (expense) income |
|
(9,452) |
|
6,429 |
|
(31,034) |
|
10,215 |
Loss before taxes |
|
(20,190) |
|
(56,352) |
|
(154,661) |
|
(251,505) |
Income tax (expense) benefit |
|
(3,967) |
|
21,971 |
|
(1,139) |
|
21,479 |
Net loss |
|
(24,157) |
|
(34,381) |
|
(155,800) |
|
(230,026) |
|
|
|
|
|
|
|
|
|
Net loss attributable to: |
|
|
|
|
|
|
|
|
Owners of the parent |
|
(24,157) |
|
(34,381) |
|
(155,800) |
|
(230,026) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
(0.30) |
|
(0.45) |
|
(1.99) |
|
(3.00) |
Condensed Consolidated Balance Sheet (Unaudited) (in KUSD) |
||||
|
|
|
|
|
ASSETS |
|
|
|
|
Current assets |
|
|
|
|
Cash and cash equivalents |
|
326,441 |
|
466,544 |
Accounts receivable, net |
|
72,971 |
|
30,218 |
Inventory |
|
18,564 |
|
11,122 |
Other current assets |
|
28,039 |
|
17,298 |
Total current assets |
|
446,015 |
|
525,182 |
Non-current assets |
|
|
|
|
Property, plant and equipment |
|
3,261 |
|
4,066 |
Right-of-use assets |
|
6,720 |
|
7,164 |
Intangible assets |
|
14,360 |
|
13,582 |
Interest in joint venture |
|
31,152 |
|
41,236 |
Deferred tax asset |
|
26,757 |
|
26,049 |
Other long-term assets |
|
903 |
|
693 |
Total non-current assets |
|
83,153 |
|
92,790 |
|
|
|
|
|
Total assets |
|
529,168 |
|
617,972 |
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
12,351 |
|
12,080 |
Other current liabilities |
|
73,035 |
|
50,497 |
Lease liabilities, short-term |
|
1,097 |
|
1,029 |
Current income tax payable |
|
— |
|
3,754 |
Senior secured term loans, short-term |
|
12,474 |
|
— |
Convertible loans, short-term |
|
— |
|
6,575 |
Total current liabilities |
|
98,957 |
|
73,935 |
Non-current liabilities |
|
|
|
|
Senior secured term loans, long-term |
|
97,240 |
|
— |
Convertible loans, long-term |
|
— |
|
87,153 |
Convertible loans, derivatives |
|
— |
|
37,947 |
Warrant obligations |
|
1,788 |
|
— |
Deferred royalty obligation, long-term |
|
212,353 |
|
218,664 |
Deferred gain of joint venture |
|
23,539 |
|
23,539 |
Lease liabilities, long-term |
|
6,564 |
|
6,994 |
Defined benefit pension liabilities |
|
— |
|
3,652 |
Total non-current liabilities |
|
341,484 |
|
377,949 |
|
|
|
|
|
Total liabilities |
|
440,441 |
|
451,884 |
|
|
|
|
|
Equity attributable to owners of the parent |
|
|
|
|
Share capital |
|
7,312 |
|
6,445 |
Share premium |
|
1,007,452 |
|
981,827 |
|
|
(679) |
|
(128) |
Other reserves |
|
155,683 |
|
102,646 |
Cumulative translation adjustments |
|
(356) |
|
183 |
Accumulated losses |
|
(1,080,685) |
|
(924,885) |
Total equity attributable to owners of the parent |
|
88,727 |
|
166,088 |
|
|
|
|
|
Total liabilities and equity |
|
529,168 |
|
617,972 |
Reconciliation of IFRS Measures to Non-IFRS Measures (Unaudited) (in KUSD except for share and per share data) |
|||||||
|
For the Three Months
|
|
For the Years Ended
|
||||
in KUSD (except for share and per share data) |
2022 |
|
2021 |
|
2022 |
|
2021 |
Net loss |
(24,157) |
|
(34,381) |
|
(155,800) |
|
(230,026) |
Adjustments: |
|
|
|
|
|
|
|
Share-based compensation expense (i) |
8,344 |
|
13,539 |
|
50,637 |
|
60,555 |
Convertible loans, derivatives, change in fair value income (ii) |
— |
|
(18,614) |
|
(25,650) |
|
(34,893) |
Convertible loans, second tranche, derivatives, transaction costs (iii) |
— |
|
— |
|
— |
|
148 |
Loss on extinguishment (iv) |
— |
|
— |
|
42,114 |
|
— |
Senior secured term loans, warrants, change in fair value income (ii) |
(419) |
|
— |
|
(2,962) |
|
— |
Effective interest expense on convertible loans (v) |
— |
|
3,025 |
|
7,684 |
|
10,418 |
|
(2,086) |
|
— |
|
(11,504) |
|
— |
Senior secured term loan facility, warrants, transaction costs (iii) |
— |
|
— |
|
245 |
|
— |
Effective interest expense on senior secured term loan facility (v) |
3,912 |
|
— |
|
5,845 |
|
— |
Deferred royalty obligation interest expense (vi) |
5,844 |
|
5,506 |
|
23,200 |
|
6,752 |
Deferred royalty obligation cumulative catch-up adjustment expense (income) (vi) |
631 |
|
936 |
|
(15,482) |
|
936 |
Adjusted net loss |
(7,931) |
|
(29,989) |
|
(81,673) |
|
(186,110) |
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
(0.30) |
|
(0.45) |
|
(1.99) |
|
(3.00) |
Adjustment to net loss per share, basic and diluted |
0.20 |
|
0.06 |
|
0.94 |
|
0.58 |
Adjusted net loss per share, basic and diluted |
(0.10) |
|
(0.39) |
|
(1.05) |
|
(2.42) |
Weighted average shares outstanding, basic and diluted |
80,463,306 |
|
76,801,875 |
|
78,152,964 |
|
76,748,204 |
(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 statement of operations 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, senior secured term loan facility warrants and the |
|
(iii) |
The transaction costs allocated to the convertible loan second tranche derivative as well as the senior secured term loan facility warrant obligation represent actual costs. We do not believe that these costs reflect the performance of our ongoing business. |
|
(iv) |
As a result of the exchange agreement entered into on |
|
(v) |
Effective interest expense on convertible loans and senior secured term loans relates to the increase in the value of our loans in accordance with the amortized cost method. |
|
(vi) |
Deferred royalty obligation interest expense relates to the accretion expense on our deferred royalty obligation pursuant to the royalty purchase agreement with HCR and cumulative catch-up adjustment expense (income) relates to changes in the expected payments to HCR based on a periodic assessment of our underlying revenue projections. |
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Investors
Eugenia.Litz@adctherapeutics.com
+44 7879 627205
amanda.loshbaugh@adctherapeutics.com
+1 917-288-7023
Media
maryann.ondish@adctherapeutics.com
+1 914-552-4625
Source:
FAQ
What were the Q4 2022 financial results for ADC Therapeutics (ADCT)?
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What is the future revenue potential of ZYNLONTA?
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