-- Five-fold increase in net sales of TAVNEOS® (avacopan) quarter-over-quarter with
-- Marked growth in key performance indicators (Q1 2022 to Q4 2021 comparison):
- 195% TAVNEOS new Patient Start Forms
- 275% Unique Prescribers
- 308% Patients on Drug --
-- Global expansion continues with approvals in
-- Positive Phase I data on pharmacokinetics (PK) and pharmacodynamics (PD) including evidence of immune activation for once daily, orally administered PD-L1 inhibitor, CCX559 --
-- Well capitalized with approximately
-- Conference call today at 5:00 p.m. Eastern Time --
“Strong performance was evident in the first quarter,” said
Beyond TAVNEOS, compelling data now is emerging from the Phase I study of our orally administered PD-L1 immune checkpoint inhibitor, CCX559. The PK and PD data presented at the recent
Key First Quarter 2022 Highlights and Recent Developments
- TAVNEOS® (avacopan) Commercial Progress
- Commercial Execution: TAVNEOS generated net product sales of approximately
$5.4 million during the first quarter of 2022 from US commercial sales.- 248 new patient start forms (PSFs) received for TAVNEOS during the first quarter of 2022.
- 281 unique prescribers to date.
- 277 patients on drug (POD) as of
March 31, 2022 .
- Continued Traction Ex-US: TAVNEOS was approved in the
European Union (EU) inJanuary 2022 , followed by an additional approval inCanada inApril 2022 for the treatment of ANCA-associated vasculitis.- ChemoCentryx’s partner, Vifor Pharma, recently initiated marketing activities for TAVNEOS in
Germany during February followed byAustria in March, and expects to launch in other markets in 2022. Vifor will payChemoCentryx royalties in the teens to the mid-20s percent on aggregate net sales from the Vifor territories outside the US. The EU approval triggered a non-refundable$45 million milestone payment from Vifor. The cash payment has been received in full and is included in the Company’s reported cash balance. Collaboration revenue (distinct from product sales) will be recognized in the future as underlying development activities occur, in accordance with ASC606, which is currently estimated to be over a four year period, subject to adjustment from time to time.
- ChemoCentryx’s partner, Vifor Pharma, recently initiated marketing activities for TAVNEOS in
- Commercial Execution: TAVNEOS generated net product sales of approximately
- TAVNEOS® (avacopan) Clinical Development:
- Lupus nephritis (LN): ChemoCentryx expects to receive feedback from the FDA mid-year 2022 regarding the clinical development plan for TAVNEOS in LN, which it plans to initiate during the second half of 2022.
- Severe hidradenitis suppurativa (HS): The Company plans to meet with the FDA to discuss the Phase III development of TAVNEOS in patients with Hurley Stage III (severe) HS late in the second quarter, with the goal of initiating a Phase III clinical trial in those patients in the second half of 2022.
- C3 glomerulopathy (C3G): The Company anticipates meeting with the FDA during the second half of the year to discuss the dataset from the ACCOLADE Phase II clinical trial of TAVNEOS in the very rare disorder of C3G, for which there are no FDA approved therapies.
CCX559 Clinical Development :- CCX559 is a novel, orally administered PD-L1 checkpoint inhibitor being developed for the treatment of various cancers, currently being evaluated in a Phase I dose escalation study. An orally administered small molecule inhibitor of PD-L1 could have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors, reduced immunogenicity, lack of Fc-mediated side effects and convenience of oral administration.
- At the
American Association for Cancer Research (AACR) Annual Meeting 2022 in April,ChemoCentryx reported preclinical data along with pharmacokinetic (PK) and pharmacodynamic (PD) data available from patients with advanced cancer who were enrolled in the first three dose cohorts of the ongoing Phase I study. Data show CCX559 is pharmacologically active in cancer patients and exhibits immune system activating properties. ChemoCentryx intends to present additional clinical data, including further escalating dose level data, at major oncology conferences through 2022. The Company is on track to initiate a Phase Ib/II clinical trial to measure anti-tumor effects of CCX559 more directly during the second half of 2022.
- Cash Position: The Company maintained a strong balance sheet with cash, cash equivalents and investments of approximately
$371.8 million as ofMarch 31, 2022 . This includes a$45 million milestone received from Vifor Pharma in the first quarter of 2022 following the EU approval of TAVNEOS.
First Quarter 2022 Financial Results
TAVNEOS US net product sales were
Collaboration revenue is recognized ratably in proportion to actual costs incurred as a percentage of total program budgeted costs as the Company completes its performance obligations under its alliance agreements. The
Cost of sales for the first quarter ended March 31, 2022, was $0.2 million. Costs incurred for manufacturing campaigns initiated prior to the
Research and development expenses were
Selling, general and administrative expenses were
Net loss for the first quarter of 2022 was
Total shares outstanding as of
Cash, cash equivalents and investments totaled approximately
Conference Call and Webcast
The Company will host a conference call and webcast today,
INDICATION
TAVNEOS® (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the excipients
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease.
Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established.
Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation and consult with experts before resuming.
Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common.
ADVERSE REACTIONS
The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased and paresthesia.
DRUG INTERACTIONS
Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.
Please see Full Prescribing Information and Medication Guide for TAVNEOS.
About TAVNEOS® (avacopan)
TAVNEOS (avacopan), approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. TAVNEOS’s selective inhibition of only the C5aR is believed to leave the beneficial C5a pathway through the C5L2 receptor functioning normally.
About ANCA-Associated Vasculitis
ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.
About
TAVNEOS® is a registered trademark of
Forward-Looking Statements
Contacts
Investors:
Vice President, Investor Relations & Corporate Communications
650.210.2970
bslattery@chemocentryx.com
Media:
408.234.1279
media@chemocentryx.com
Condensed Consolidated Financial Statements Data | |||||||
(in thousands, except per share data) | |||||||
Three Months Ended | |||||||
2022 | 2021 | ||||||
(unaudited) | |||||||
Condensed Consolidated Statements of Operations Data: | |||||||
Revenue: | |||||||
Product sales, net | $ | 5,353 | $ | — | |||
Collaboration and license revenue from related party | 106 | 10,223 | |||||
Grant revenue | — | 130 | |||||
Total revenue | 5,459 | 10,353 | |||||
Operating expenses: | |||||||
Cost of sales | 205 | — | |||||
Research and development | 17,476 | 23,418 | |||||
Selling, general and administrative | 26,011 | 16,262 | |||||
Total operating expenses | 43,692 | 39,680 | |||||
Loss from operations | (38,233 | ) | (29,327 | ) | |||
Other expense, net | (375 | ) | (384 | ) | |||
Net loss | $ | (38,608 | ) | $ | (29,711 | ) | |
Basic and diluted net loss per common share | $ | (0.55 | ) | $ | (0.43 | ) | |
Shares used to compute basic and diluted net loss per common share | 70,835 | 69,608 | |||||
2022 | 2021 | ||||||
(unaudited) | |||||||
Condensed Consolidated Balance Sheets Data: | |||||||
Cash, cash equivalents and investments | $ | 371,836 | $ | 362,348 | |||
Working capital | 282,825 | 206,160 | |||||
Total assets | 440,453 | 425,652 | |||||
Long-term debt, net | 23,682 | 23,635 | |||||
Accumulated deficit | (655,705 | ) | (617,097 | ) | |||
Total stockholders’ equity | 258,719 | 286,120 | |||||
Source:
2022 GlobeNewswire, Inc., source