RD Expenses: Research and development (RD) expenses were $41.0 million for the three months ended March 31, 2019, compared to $75.6 million for the three months ended March 31, 2018. The decrease of $34.6 million was primarily due to the upfront payment to BMS in the three months ended March 31, 2018 of $50.0 million, partially offset by increases in direct costs of $6.3 million for the BHV-3500 program, $3.4 million in personnel costs, including non-cash share-based compensation, $3.4 million in direct costs for the troriluzole program, and $2.0 million in direct costs for the rimegepant program. The increases in direct costs for the BHV-3500 and troriluzole programs were primarily due to an increase in the number of clinical trials, and the cost of operating later-stage trials, for the three months ended March 31, 2019 as compared to the same period in 2018. The increase in personnel-related costs, including non-cash share-based compensation, was a result of hiring additional research and development personnel. Headcount in RD increased to 43 as of March 31, 2019, compared to 29 as of March 31, 2018. Non-cash share-based compensation expense, included in personnel-related costs, was $3.7 million for the three months ended March 31, 2019, an increase of $2.3 million as compared to the same period in 2018.
GA Expenses: General and administrative (GA) expenses were $13.5 million for the three months ended March 31, 2019, compared to $7.9 million for the three months ended March 31, 2018. The increase of $5.6 million was primarily due to increases in personnel-related costs, including non-cash share-based compensation, due to the hiring of additional personnel in GA functions, preparation for commercialization activities, professional fees supporting ongoing business operations, and additional fees to comply with being a public company. Headcount, outside of RD, increased to 30 as of March 31, 2019, compared to 20 as of March 31, 2018. Non-cash share-based compensation expense, included in personnel-related costs, was $3.6 million for the three months ended March 31, 2019, an increase of $2.0 million as compared to the same period in 2018.
Net Loss: The Company reported a net loss attributable to common shareholders of $62.3 million or $1.41 per share for the three months ended March 31, 2019, compared to $85.5 million, or $2.32 per share, for the three months ended March 31, 2018.
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven’s lead development programs include multiple compounds across its CGRP receptor antagonist and glutamate modulator platforms. The Company’s common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is available at www.biohavenpharma.com.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal 2018 generated approximately $2.5 billion in annual revenue. Zydis® is a registered trademark of Catalent. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company’s management. All statements, other than statements of historical facts, included in this press release regarding the Company’s business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected commencement and completion of clinical trials, the anticipated timing of availability of data from those trials, the timing of expected regulatory submissions and approvals, the efficacy and safety profiles of the Company’s product candidates and their expected benefits compared to other treatment options, and other statements regarding the Company’s plans and objectives, expectations and assumptions of management. The use of certain words, including the words “expect,” “anticipate,” “will,” “potential,” “plan,” “might” and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by the forward-looking statements including risks and uncertainties related to the timing of initiating, enrolling and completing clinical trials; the commencement or completion of enrollment in any clinical trial does not guarantee the continuation or successful outcome of the trial, or the acceptance by the FDA of a regulatory package for the drug candidate being tested; the submission of an IND does not guarantee that the FDA will permit clinical trials to begin; and those factors described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019 and the Company’s other filings with the Securities and Exchange Commission. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
For further information, contact Dr. Vlad Coric, Chief Executive Officer, at Vlad.Coric@biohavenpharma.com
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