On November 4, 2021 Kadmon Holdings, Inc. (NASDAQ:KDMN) reported financial and operational results for the third quarter of 2021 (Press release, Kadmon, NOV 4, 2021, View Source [SID1234594495]).
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"The third quarter was an exceptional period for Kadmon culminating in the availability of REZUROCK to patients living with cGVHD and the significant milestones that were achieved in the months following our strategic commercial launch," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "Our previously-announced merger with Sanofi is expected to close as soon as November 9, 2021, with a special meeting of stockholders scheduled for November 5, 2021. We are pleased that Sanofi has recognized the value of belumosudil and, pending the close of the merger, look forward to leveraging their expertise and resources to continue to build on our momentum."
Dr. Waksal added, "In addition to our commercial efforts, our clinical and preclinical work in other therapeutic areas remain underway. We continue to advance belumosudil forward in systemic sclerosis and continue to dose patients with KD033, our anti-PD-L1/IL-15 fusion protein. Our research and development efforts have also moved forward two product candidates (KD050 and KD045) that we anticipate will be in the clinic in 2022. I am so proud of the work taking place at Kadmon, and look forward to seeing the programs developed here continuing to progress."
2021 Program Updates and Milestones:
Sanofi Acquisition
On September 7, 2021, Kadmon entered into a definitive merger agreement with Sanofi:
The acquisition supports Sanofi’s strategy to continue to grow its General Medicines core assets and will immediately add REZUROCK to its transplant portfolio
Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis)
The acquisition remains subject to satisfaction or waiver of certain conditions to closing, as set forth in the definitive merger agreement
The Sanofi and Kadmon Boards of Directors unanimously approved the transaction and the transaction is expected to close in the fourth quarter of 2021
REZUROCK (belumosudil)
On August 19, 2021 REZUROCK became commercially available for shipment to prescribed patients in the United States through a network of rare hematology/oncology specialty pharmacies and distributors
Execution of commercial launch remain underway, with a focus on generating awareness of REZUROCK’s differentiated clinical value and facilitating market access
Experienced field team call on all target accounts, including engagement with 100% of the top 80 transplant centers, where ~90% of chronic graft-versus-host disease (cGVHD) patients in the U.S. are treated
Strong sales performance and demand during initial launch period; $12.2 million net sales achieved in 3Q 2021
The Company plans to present data on belumosudil at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 11 – 14, 2021
Pipeline
Belumosudil in SSc (systemic sclerosis)
Present initial data from the open-label Phase 2 clinical trial of belumosudil in patients with SSc (KD025-215) by year-end 2021
Continue enrollment in ongoing placebo-controlled Phase 2 clinical trial in SSc (KD025-209)
KD033
Enrollment is ongoing in Cohort 5 (200 µg/kg) in the dose-escalation, Phase 1 clinical trial of KD033, Kadmon’s anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors (KD033-101)
The Company plans to present data from KD033-101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, to be held November 10 – 14, 2021
KD050
Continue ongoing Investigational New Drug Application (IND)-enabling activities of KD050, Kadmon’s anti-PD1/IL15 fusion molecule; IND target for 1H 2022
KD045
Continue ongoing Investigational New Drug Application (IND)-enabling activities of KD045, Kadmon’s next-generation ROCK inhibitor, for the treatment of fibrotic diseases; IND target for 4Q 2021
Financial Results
Third Quarter 2021 Results
Net sales for the three and nine months ended September 30, 2021 were $12.2 million and $12.6 million, respectively, compared to $0.3 million and $1.2 million for the same periods in 2020. The increases are attributable to the approval and commercialization of REZUROCK in the United States, which generated approximately $12.2 million of net sales for the three and nine months ended September 30, 2021.
Other revenues for the three and nine months ended September 30, 2021 were $2.5 million and $2.9 million, respectively, compared to $0.2 million and $6.4 million for the same periods in 2020. Other revenues during the three and nine months ended September 30, 2021 include $2.0 million in one-time license revenues related to the BioNova strategic partnership and other revenues during the nine months ended September 30, 2020 include $6.0 million in one-time license revenues related to the Meiji strategic partnership.
Operating expenses increased by approximately $12.3 million and $23.5 million for the three and nine months ended September 30, 2021, respectively, as compared to 2020, primarily related to REZUROCK commercial launch activities, non-cash stock compensation expenses and direct external research and development costs of developing our preclinical product candidates from our immuno-oncology platform.
Liquidity, Capital Resources and Cash Runway
At September 30, 2021, the Company’s cash, cash equivalents and marketable debt securities totaled $251.6 million, compared to $123.9 million at December 31, 2020. The Company expects its current financial position to be sufficient to fund its operations and capital expenditures into 2023.
About REZUROCK (belumosudil)
REZUROCK (belumosudil) is the first and only approved therapy targeting Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and pro-fibrotic processes. REZUROCK is approved in the United States for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy. For more information, visit www.REZUROCK.com.
Kadmon is also developing belumosudil for the treatment of systemic sclerosis. The FDA has granted Orphan Drug Designation to belumosudil for the treatment of systemic sclerosis.
INDICATIONS AND USAGE
REZUROCK is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
SELECT IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception.
Adverse Reactions
The most common (≥20%) adverse reactions, including laboratory abnormalities, in patients receiving REZUROCK were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension.
To report suspected adverse reactions, contact Kadmon at 1-877-377-7862 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
Use in Specific Populations
Lactation: Advise not to breastfeed.
Please visit www.REZUROCK.com to see the full Prescribing Information for REZUROCK.