Dr. Raymond Urbanski

Valencia-based MannKind Corp. has appointed Dr. Raymond Urbanski as its Chief Medical Officer, the company announced Monday. As Chief Medical Officer, Dr. Urbanski will lead MannKind’s overall drug development activities and will be a member of the Executive Leadership Team.

“Dr. Urbanski is a terrific addition to our team and I am very pleased to have a person of his caliber as part of the organization,” said MannKind’s Chief Executive Officer, Hakan Edstrom. “Ray’s experience in drug development across multiple therapeutic areas, combined with his proven leadership capabilities, will be invaluable to us as we drive growth through our product technology platforms.”

Dr. Urbanski has more than 25 years of research, clinical and pharmaceutical industry experience developing numerous new drugs and indications across oncology, rheumatology, cardiology, endocrinology, and immunology. He has held CMO roles at Mylan and Metabolix. Previously he was Vice President at Pfizer, and Vice President and CMO at Suntory Pharmaceuticals. He earned both his MD and Ph.D., Pharmacology and Toxicology from the University of Medicine and Dentistry of New Jersey – New Jersey Medical School.

—

Valencia-based MannKind Corp. reported financial results Monday for the second quarter ended June 30, 2015.

For the three and six months ended June 30, 2015, product shipments of Afrezza, our novel rapid-acting inhaled insulin therapy, were $5.9 million and $13.0 million, respectively, which we recorded as deferred product sales from our collaboration with Sanofi. For the quarter ended June 30, 2015, our portion of the loss sharing arrangement with Sanofi related to Afrezza was $12.8 million, which we subsequently financed by way of an advance under the loan facility with an affiliate of Sanofi after June 30, 2015. The amount currently outstanding under the Sanofi loan facility is now $28.4 million, which includes $0.2 million in paid-in-kind interest.

For the second quarter of 2015, total operating expenses decreased from $69.8 million to $24.1 million, a decline of 65.5% compared to the same quarter in 2014, primarily due to Afrezza having moved out of clinical development into the commercial market. Additionally, non-cash stock compensation from the non-recurring achievement of performance and modification events in 2014 decreased in the second quarter of 2015 as compared to the second quarter of 2014. Research and development expenses decreased from $37.3 million to $7.7 million, a decrease of 79.4%, reflecting the transition from development to commercial activities. General and administrative expenses decreased from $32.5 million to $10.6 million, a reduction of 67.4%, mainly due to the decrease in non-cash stock compensation expense. Offsetting the total decrease of $51.5 million in R&D and G&A for the second quarter of 2015 was product manufacturing costs of $5.7 million. We did not recognize any product manufacturing costs in the second quarter of 2014 as we had not yet commenced commercialization of Afrezza.

For the first six months of 2015, operating expenses were $45.8 million, a decline of 58.8% compared to the same period in 2014. Total research and development expenses for the six months ended June 30, 2015 were $17.1 million, a decline of 73.1% compared to the same period in 2014, primarily due to reduced non-cash stock compensation expense resulting from the non-recurring achievement of performance and modification events in 2014 and in the first quarter of 2015. General and administrative expenses for the six months ended June 30, 2015 were $21.1 million, a decrease of 55.9% compared to the same period in 2014, primarily due to reduced non-cash stock compensation expense resulting from the non-recurring achievement and modification events in 2014 and in the first quarter of 2015.

The net loss for the second quarter of 2015 was $28.9 million, or $0.07 per share, based on 401.0 million weighted average shares outstanding, compared with a net loss of $73.4 million, or $0.19 per share, based on 380.8 million weighted average shares outstanding for the second quarter of 2014. The number of common shares outstanding at June 30, 2015 was 412.3 million.

Cash and cash equivalents were $107.2 million at June 30, 2015, compared to $120.8 million in the first quarter of 2015. During the second quarter of 2015, we received $6.7 million in proceeds from warrant and option exercises, $5.5 million in payments from Sanofi for product shipments, and $2.1 million in proceeds from our at-the-market sales facility. Currently, $30.1 million remains available to borrow under our amended loan arrangement with The Mann Group.
About MannKind Corporation

MannKind Corporation (MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.