Kadmon Provides Business Update and Reports Second Quarter 2017 Financial Results

NEW YORK--(BUSINESS WIRE)--Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”) today provided a business update and reported financial and operational results for the three and six months ended June 30, 2017.

“This is an exciting time for Kadmon as we execute on clinical milestones for KD025, our ROCK2 inhibitor in Phase 2 development. We recently announced positive clinical data in chronic graft-versus-host disease (cGVHD), with additional milestones expected in the second half of 2017, including further cGVHD data as well as results from an ongoing trial in idiopathic pulmonary fibrosis,” said Harlan W. Waksal, M.D., President and Chief Executive Officer of Kadmon. “In parallel, we continue to focus our development capabilities on our ROCK inhibitor platform for the treatment of autoimmune, fibrotic and neurodegenerative diseases.”

Clinical and Research Update

KD025 in Autoimmune and Fibrotic Diseases

The Company is conducting three ongoing Phase 2 clinical trials as follows:

• Open-label, dose-finding clinical trial in cGVHD – additional study results submitted for presentation at upcoming scientific conferences
• Randomized, open-label clinical trial in idiopathic pulmonary fibrosis – initial data expected Q4 2017
• Randomized, placebo-controlled clinical trial in moderate to severe psoriasis – approximately 50% enrolled

Additional Clinical Updates

In Q3 2017, the Company expects to initiate a randomized, double-blind, placebo-controlled Phase 2 clinical trial of tesevatinib in autosomal dominant polycystic kidney disease (PKD) and a dose-finding Phase 1 clinical trial of tesevatinib in autosomal recessive PKD. Enrollment continues in the Company’s ongoing Phase 2 clinical trials of tesevatinib in glioblastoma and in non-small cell lung cancer with brain or leptomeningeal metastases.

The U.S. Food and Drug Administration (FDA) provided a Generic Drug User Fee Amendments of 2012 (GDUFA) goal date of January 30, 2018, to review the Company’s Abbreviated New Drug Application (ANDA) for KD034, its generic trientine hydrochloride formulation for the treatment of Wilson’s disease, in blister packaging that offers room temperature stability. The Company submitted its first ANDA for its bottled generic trientine hydrochloride formulation in December 2016.

Financial Results

Second Quarter 2017 Results

Loss from operations for the three and six months ended June 30, 2017 was $17.6 million and $31.6 million, respectively, compared to $22.2 million and $42.6 for the respective periods in 2016.

Revenue was $3.0 million and $8.5 million for the three and six months ended June 30, 2017, respectively, compared to $6.4 million and $16.1 million for the respective periods in 2016. The Company expects sales of its ribavirin portfolio of products to contribute insignificantly to revenue in 2017 and beyond.

Research and development expenses were $10.1 million and $18.5 million for the three and six months ended June 30, 2017, respectively, compared to $8.6 million and $17.7 million for the respective periods in 2016.

SG&A expenses were $9.9 million and $20.0 million for the three and six months ended June 30, 2017, respectively, compared to $19.1 million and $42.8 million for the respective periods in 2016. The decrease in SG&A expenses for the second quarter of 2017 is primarily related to a decrease in legal expenses of $2.7 million, salary and salary-related expense of $1.2 million, consulting expense related to an advisory agreement of $0.8 million and amortization of intangible assets of $3.4 million.

Liquidity and Capital Resources

As of June 30, 2017, Kadmon’s cash and cash equivalents totaled $26.2 million, compared to $36.1 million as of December 31, 2016. In March 2017, Kadmon completed a private placement equity financing pursuant to which Kadmon received gross proceeds of approximately $23 million from the issuance of 6,767,855 shares of Kadmon’s common stock, at a price of $3.36 per share, and warrants to purchase 2,707,138 shares of Kadmon’s common stock at an initial exercise price of $4.50 per share for a term of 13 months from the date of issuance. If these warrants are exercised, the Company would receive approximately $12.2 million.

About Kadmon Holdings, Inc.

Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company developing innovative products for significant unmet medical needs. We have a diversified product pipeline focused on autoimmune and fibrotic diseases.