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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Kadmon Holdings Inc | NYSE:KDMN | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 3.53 | 0 | 01:00:00 |
-- Continuing to Streamline Operations While Advancing Clinical Pipeline --
Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”) today provided a business update and reported financial and operational results for the three months ended March 31, 2017.
“We have further streamlined our operations and reduced costs, allowing us to focus our resources towards rapidly advancing our clinical pipeline,” said Harlan W. Waksal, M.D., President and Chief Executive Officer at Kadmon. “We look forward to executing on our multiple clinical milestones in the second half of 2017, which include data readouts from our ongoing Phase 2 studies evaluating our ROCK2 inhibitor, KD025.”
Clinical and Research Update
KD025
The Company expects to report data from its three ongoing Phase 2 clinical trials as follows:
Tesevatinib
KD034
Operations Update
Kadmon continues to implement operational changes to increase efficiency and to prioritize the development of its clinical pipeline and drug discovery efforts:
Financial Results
First Quarter 2017 Results
Loss from operations was $13.9 million for the three months ended March 31, 2017, compared to $20.5 million for the same period in 2016.
Revenue was $5.6 million for the three months ended March 31, 2017, compared to $9.7 million for the same period in 2016. The Company expects sales of its ribavirin portfolio of products to contribute insignificantly in 2017 and beyond.
Research and development expenses were $8.4 million for the three months ended March 31, 2017, compared to $9.1 million for the same period in 2016.
SG&A expenses were $10.1 million for the three months ended March 31, 2017, compared to $23.7 million for the same period in 2016. The decrease in SG&A expenses for the first quarter of 2017 is primarily related to a decrease in salary and salary-related expense of $3.4 million, consulting expense related to an advisory agreement of $2.3 million and amortization of intangible assets of $5.6 million.
Liquidity and Capital Resources
As of March 31, 2017, Kadmon’s cash and cash equivalents totaled $43.0 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 in autoimmune and fibrotic diseases, oncology and genetic diseases.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, clinical trials, plans, and objectives of management, are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Kadmon cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. There are a number of important factors that could cause Kadmon’s actual results to differ materially from those indicated or implied by its forward-looking statements. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) our reliance on the success of our product candidates; (iv) the timing or likelihood of regulatory filings and approvals; (v) our ability to expand our sales and marketing capabilities; (vi) the commercialization of our product candidates, if approved; (vii) the pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in the United States, Europe and other jurisdictions; (xiii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xv) our ability to maintain and establish collaborations or obtain additional grant funding; (xvi) the rate and degree of market acceptance of our product candidates; (xvii) developments relating to our competitors and our industry, including competing therapies; (xviii) our ability to effectively manage our anticipated growth; (xix) our ability to attract and retain qualified employees and key personnel; (xx) our ability to achieve anticipated cost savings and other benefits from our efforts to streamline our operations and to not harm our business with such efforts; (xxi) our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act; (xxii) statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and share performance; (xxiii) litigation, including costs associated with prosecuting or defending pending or threatened claims and any adverse outcomes or settlements, whether or not covered by insurance; (xxiv) our expected use of proceeds from our initial public offering, March 2017 private placement and other sources of liquidity; (xxv) the future trading price of the shares of our common stock and impact of securities analysts’ reports on these prices; and/or (xxvi) other risks and uncertainties. More detailed information about Kadmon and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including, without limitation, the Company’s prospectus filed pursuant to Rule 424(b) under the Securities Act with the SEC on July 27, 2016 and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Kadmon Holdings, Inc. Consolidated Statements of Operations - Unaudited (in thousands, except per share data) Three Months Ended March 31, 2017 2016 Revenues Net sales $ 2,336 $ 6,192 License and other revenue 3,230 3,471 Total revenue 5,566 9,663 Cost of sales 567 1,085 Write-down of inventory 370 135 Gross profit 4,629 8,443 Operating expenses: Research and development 8,447 9,083 Selling, general and administrative 10,118 23,686 Gain on settlement of payable — (3,875) Total operating expenses 18,565 28,894 Loss from operations (13,936) (20,451) Total other expense 3,315 12,407 Income tax expense 316 315 Net loss $ (17,567) $ (33,173) Deemed dividend on convertible preferred stock 469 — Net loss attributable to common stockholders $ (18,036) $ (33,173) Basic and diluted net loss per share of common stock $ (0.39) $ (4.00) Weighted average basic and diluted shares of common stock outstanding 46,507,435 8,302,635 Kadmon Holdings, Inc. Condensed Consolidated Balance Sheets (in thousands) March 31, December 31, 2017 2016 (unaudited) Cash and cash equivalents $ 43,049 $ 36,093 Other current assets 5,516 4,194 Other noncurrent assets 19,383 22,269 Total assets $ 67,948 $ 62,556 Current liabilities $ 23,741 $ 24,746 Other long term liabilities 32,799 34,325 Secured term debt – non-current, net 31,023 28,677 Total liabilities 87,563 87,748 Total stockholders’ deficit (19,615) (25,192) Total liabilities and stockholders’ deficit $ 67,948 $ 62,556
View source version on businesswire.com: http://www.businesswire.com/news/home/20170515005546/en/
Kadmon Holdings, Inc.Ellen Tremaine, 646-490-2989Investor Relationsellen.tremaine@kadmon.comorMaeve Conneighton, 212-600-1902maeve@argotpartners.com
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