Kadmon Reports Upcoming Milestones and Fourth Quarter and Full Year 2017 Financial Results

Published: Mar 06, 2018

NEW YORK--(BUSINESS WIRE)-- Kadmon Holdings, Inc. (NYSE: KDMN) today provided an update on upcoming milestones and recent achievements, and reported financial and operational results for the fourth quarter and full year ended December 31, 2017.

“In the past year, we have delivered on multiple key milestones, including reporting positive clinical results in cGVHD and IPF. Our successes bring us closer to our goal of developing innovative therapies for major unmet medical needs,” said Harlan W. Waksal, M.D., President and Chief Executive Officer at Kadmon. “We are in a strong financial position to continue our programs in these and other diseases, with an emphasis on defining pathways to regulatory approval.”

2018 Anticipated Key Clinical Milestones:

KD025

  • Continue dialogue with the U.S. Food and Drug Administration (FDA) regarding the Company’s regulatory strategy for KD025 in various clinical indications
  • Initiate new Phase 2 clinical trial in cGVHD
  • Initiate new Phase 2 clinical trial in IPF
  • Initiate new Phase 2 clinical trial in scleroderma

KD034

  • Continue dialogue with the FDA regarding its review and potential approval of KD034, the Company’s generic trientine hydrochloride formulation, for the treatment of Wilson’s disease

Fourth Quarter 2017 and Recent Highlights

KD025

  • In October 2017, the FDA granted orphan drug designation to KD025 for the treatment of cGVHD. Throughout 2017 and early 2018, Kadmon reported positive results from the ongoing Phase 2 clinical trial in patients with steroid-dependent or refractory cGVHD, achieving clinical responses in approximately two-thirds of patients, with no treatment-related serious adverse events.
  • In early 2018, Kadmon reported positive findings from the ongoing Phase 2 clinical trial in IPF, showing that KD025 was well tolerated and demonstrated clinical activity, with a median decline in forced vital capacity (FVC), a measure of lung function, of 48 mL at week 24, compared to a median decline of 175 mL with best supportive care, an absolute difference of 127 mL and a relative difference of 73%.
  • Kadmon is designing a Phase 2 clinical trial of KD025 in scleroderma (also known as systemic sclerosis), a disease in which ROCK inhibition has been shown to have significant potential.

Tesevatinib

  • In November 2017, Kadmon initiated a Phase 2, randomized, double-blind, placebo-controlled trial of tesevatinib for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
  • In September 2017, Kadmon initiated a Phase 1 dose-finding clinical trial of tesevatinib for the treatment of autosomal recessive polycystic kidney disease (ARPKD).

KD034

  • In December 2016, Kadmon submitted an ANDA for its bottled generic formulation of trientine hydrochloride. In March 2017, Kadmon submitted a second ANDA for its generic form of trientine hydrochloride in blister packaging that offers room temperature stability. The Company is in dialogue with the FDA regarding the FDA’s review of KD034.

Financial Results

Fourth Quarter 2017 Results

Loss from operations for the three months ended December 31, 2017 was $17.2 million, compared to $19.6 million for the same period in 2016.

Revenue for the three months ended December 31, 2017 was $1.5 million, compared to $4.3 million for the same period in 2016.

Research and development expenses for the three months ended December 31, 2017 were $10.5 million, compared to $8.5 million for the same period in 2016.

Selling, general and administrative expenses for the three months ended December 31, 2017 were $7.9 million, compared to $14.6 million for the same period in 2016.

Full Year 2017 Results

Loss from operations for the year ended December 31, 2017 was $68.6 million, compared to $115.4 million for the same period in 2016.

Revenue for the year ended December 31, 2017 was $12.3 million, compared to $26.1 million for the same period in 2016. The Company does not place significant value on its commercial operations from a revenue-generating standpoint; however, the Company leverages its commercial infrastructure to support the development of its clinical-stage product candidates by providing quality assurance, compliance, regulatory and pharmacovigilance capabilities, among others.

Research and development expenses for the year ended December 31, 2017 were $40.8 million, compared to $35.8 million for the same period in 2016.

Selling, general and administrative expenses for the year ended December 31, 2017 were $37.1 million, compared to $105.9 million for the same period in 2016. The decrease in selling, general and administrative expenses is primarily related to a decrease in share-based compensation of $34.6 million, a decrease in amortization of intangible assets of $15.2 million due to the intangible asset being fully amortized at December 31, 2016, as well as, a reduction in headcount, legal expense primarily related to legal settlements entered into during 2016, and a decrease in royalty expense and consulting fees resulting from the expiration of an advisory agreement entered into in April 2015.

Liquidity and Capital Resources

At December 31, 2017, Kadmon’s cash and cash equivalents totaled $67.5 million, compared to $36.1 million at December 31, 2016.

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