CCXI reports 2nd quarter results. Stock down 13%
August 9, 2018 4:05 PM
CHEMOCENTRYX REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS AND RECENT HIGHLIGHTS
-- Completed patient enrollment in Phase III ADVOCATE trial of avacopan in ANCA-associated vasculitis --
-- Ongoing clinical trials with avacopan in C3 Glomerulopathy (C3G) and CCX140 in Focal Segmental Glomerulosclerosis (FSGS), diseases with no approved therapies --
-- Launch of clinical development of avacopan in Hidradenitis Suppurativa (HS), an orphan dermatological disease, remains on track for 2018 --
-- Conference call today at 5:00 p.m. Eastern Time --
MOUNTAIN VIEW, Calif., Aug. 09, 2018 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq:CCXI), today announced financial results for the second quarter ended June 30, 2018 and provided an overview of the Company's recent corporate highlights.
"A most important milestone has recently been achieved at ChemoCentryx: we completed enrollment of over 300 patients in our landmark ADVOCATE Phase III trial in ANCA-associated vasculitis,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “We’re targeting the fourth quarter of 2019 for the release of top-line data from ADVOCATE, and expect that successful trial results would form the basis of our new drug application to the FDA. Our very healthy balance sheet also enables us to simultaneously pursue other high unmet need, high value disease indications. Specifically, controlled clinical trials are underway for avacopan in C3G and for our other innovative kidney asset, CCX140 in FSGS. These are all orphan renal diseases with no approved therapies. Our plan to expand into orphan dermatological disease is also progressing extremely well. We intend to launch a large controlled clinical trial of avacopan in hidradenitis suppurativa later this year. In sum, 2018 is shaping up to be a watershed year for the Company, and we believe our momentum is building.”
Recent Highlights
ChemoCentryx has completed enrollment of 316 patients in the Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA-associated vasculitis. The trial will evaluate the safety and efficacy of avacopan following 52 weeks of treatment.
Expanded commercial alliance with Vifor Pharma to provide Vifor with commercialization rights in China for avacopan and CCX140, in exchange for upfront cash payments to ChemoCentryx totaling $21.5 million, plus tiered royalties between the teens and mid-twenties on potential net future sales in the Vifor territories.
Surpassed 45% of the patient enrollment target in the Company’s clinical trial evaluating avacopan for C3G. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with relapsing disease common. There is no approved effective treatment.
Reported $91.5MM in cash receipts year-to-date; current balance sheet >$200MM in cash and equivalents.
Developed plan to launch clinical trials by the end of 2018 of avacopan in HS, an inflammatory and chronic skin disease characterized by recurrent, painful, boil-like nodules under the skin.
Launched clinical development of CCR2 inhibitor CCX140 in two sub-populations of primary FSGS, an orphan kidney disease with no approved treatment option.
Second Quarter 2018 Financial Results
Cash, cash equivalents and investments totaled approximately $201.8 million at June 30, 2018. In the first six months of 2018, ChemoCentryx received $91.5 million in cash from milestone and upfront payments and credit facility advances. Cash utilized for the first six months of the year was $25MM. For the full year, the Company expects to utilize cash and investments between $60 million and $70 million.
Revenue was $15.0 million for the second quarter of 2018, compared to $8.9 million for the same period in 2017. Revenue recognized represents amortization of the upfront license fee commitments, milestone payments and collaboration funding from Vifor pursuant to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement. The increase from 2017 to 2018 was primarily due to the Company’s adoption of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers effective January 1, 2018.
Research and development expenses were $17.8 million for the second quarter of 2018, compared to $14.3 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to the patient enrollment of the avacopan Phase II clinical trial in patients with C3G and start-up expenses related to the CCX140 Phase II clinical trials in patients with FSGS.
General and administrative expenses were $4.7 million for the second quarter of 2018, compared to $4.2 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, partially offset by a decrease in professional fees.
Net loss for the second quarter of 2018 was $6.9 million, compared to $9.2 million for the same period in 2017.
Total shares outstanding at June 30, 2018 were approximately 50.3 million shares.
Conference Call and Webcast
The Company will host a conference call and webcast today, August 9, 2018 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 6238899. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.ChemoCentryx.com. The archived webcast will remain available on the Company's website for fourteen (14) days following the conference call.
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