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8-K - 8-K - Kadmon Holdings, Inc.c142-20160907x8k.htm

Exhibit 99.1



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KADMON REPORTS FINANCIAL AND OPERATIONAL RESULTS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2016



NEW YORK, September 7, 2016Kadmon Holdings, Inc. (NYSE: KDMN), a fully integrated biopharmaceutical company engaged in the discovery, development and commercialization of small molecules and biologics to address disease areas of significant unmet medical need, today reported its financial and operational results for the three and six months ended June 30, 2016.



“Kadmon has achieved several key clinical and corporate milestones in 2016, including the recent successful completion of our initial public offering,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “As we continue to rapidly advance our pipeline, we have strengthened operational efficiency and cost-saving measures within the Company to prioritize data delivery from our ongoing and planned clinical studies.”  



Recent Developments



Corporate Conversion

On July 26, 2016, in connection with the pricing of Kadmon’s initial public offering (“IPO”), Kadmon Holdings, LLC filed a certificate of conversion, whereby Kadmon Holdings, LLC effected a corporate conversion from a Delaware limited liability company to a Delaware corporation and changed its name to Kadmon Holdings, Inc. All of the Company’s outstanding Class A, Class B, Class C and Class D units, and Class E redeemable convertible units converted into common stock and gave effect to a 1-for-6.5 reverse split.



Completion of IPO and Debt Conversion

On August 1, 2016, Kadmon completed its IPO, whereby it issued 6,250,000 shares of common stock at an offering price of $12.00 per share. Aggregate net proceeds received by the Company from the offering were $66.7 million, net of underwriting discounts and commissions of $5.3 million and offering expenses of $3.1 million. Upon the closing of the IPO, 19,034,467 shares of the Company’s common stock were issued as result of the conversion of the Company’s senior secured convertible credit agreement and second‑lien convertible paid-in-kind notes.



Financial Results



Second Quarter 2016 Results

Loss from operations for the three months ended June 30, 2016, was $21.9 million compared to a loss from operations of $21.8 million for the same period in 2015. For the six months ended June 30, 2016, the


 

Company’s loss from operations was $42.0 million compared to a loss from operations of $44.2 million for the same period in 2015. 



Revenue totaled $6.4 million and $8.8 million for the three months ended June 30, 2016 and 2015, respectively. Revenue totaled $16.1 million and $16.5 million during the six months ended June 30, 2016 and 2015, respectively.



Research and development expenses for the three months ended June 30, 2016, totaled $8.5 million compared to $7.1 million for the same period in 2015. For the six months ended June 30, 2016, research and development expenses totaled $17.6 million compared to $14.9 million for the same period in 2015.



General and administrative expenses for the three months ended June 30, 2016, totaled $18.9 million compared to $21.8 million for the same period in 2015. For the six months ended June 30, 2016, general and administrative expenses totaled $42.3 million compared to $43.0 million for the same period in 2015.



Liquidity and Capital Resources

As of June 30, 2016, Kadmon’s cash and cash equivalents totaled $5.5 million compared to $21.5 million as of December 31, 2015.  



About Kadmon Holdings, Inc.

Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company engaged in the discovery, development and commercialization of small molecules and biologics to address disease areas of significant unmet medical need. Kadmon is developing product candidates within 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; and (xix) our ability to attract and retain qualified employees and key personnel. 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 Quarterly Report on Form 10-Q for the period ended June 30, 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.

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except per share data)



 

 

 

 

 

 

 

 

 

 

 

 

   

 

Three Months Ended

 

Six Months Ended



 

June 30,

 

June 30,



 

2016

 

2015

 

2016

 

2015



 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

4,967 

 

$

7,304 

 

$

11,159 

 

$

13,774 

License and other revenue

 

 

1,453 

 

 

1,475 

 

 

4,924 

 

 

2,723 

Total revenue

 

 

6,420 

 

 

8,779 

 

 

16,083 

 

 

16,497 

Cost of sales

 

 

880 

 

 

879 

 

 

1,965 

 

 

1,838 

Writedown of inventory

 

 

 

 

821 

 

 

137 

 

 

926 

Gross profit

 

 

5,538 

 

 

7,079 

 

 

13,981 

 

 

13,733 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

8,544 

 

 

7,065 

 

 

17,584 

 

 

14,905 

Selling, general and administrative

 

 

18,869 

 

 

21,815 

 

 

42,269 

 

 

43,011 

Gain on settlement of other milestone payable

 

 

 

 

 

 

(3,875)

 

 

Total operating expenses

 

 

27,413 

 

 

28,880 

 

 

55,978 

 

 

57,916 

Loss from operations

 

 

(21,875)

 

 

(21,801)

 

 

(41,997)

 

 

(44,183)

Other expense (income)

 

 

14,837 

 

 

(19,276)

 

 

27,244 

 

 

(13,650)

Income tax expense

 

 

 —

 

 

 —

 

 

315 

 

 

 —

Net loss

 

$

(36,712)

 

$

(2,525)

 

$

(69,556)

 

$

(30,533)



 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share of common stock

 

$

(4.42)

 

$

(0.31)

 

$

(8.38)

 

$

(3.83)

Weighted average basic and diluted shares of common stock outstanding

 

 

8,304,334 

 

 

8,122,691 

 

 

8,303,484 

 

 

7,976,210 




 







 

 

 

 

 

 

Kadmon Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands)



 

 

 

 

 

 



 

June 30,

 

December 31,

  

 

2016

 

2015



 

(unaudited)

 

 

Cash and cash equivalents

 

$

5,544 

 

$

21,498 

Other current assets

 

 

7,689 

 

 

11,243 

Other noncurrent assets

 

 

32,639 

 

 

51,396 

Total assets

 

$

45,872 

 

$

84,137 



 

 

 

 

 

 

Current liabilities

 

 

46,654 

 

 

49,686 

Other long term liabilities

 

 

33,735 

 

 

36,783 

Secured term debt – net of current portion and discount

 

 

25,381 

 

 

26,264 

Convertible debt, net of discount

 

 

196,720 

 

 

183,457 

Total liabilities

 

 

302,490 

 

 

296,190 

Commitments and contingencies

 

 

82,565 

 

 

58,856 

Total stockholders’ deficit

 

 

(339,183)

 

 

(270,909)

Total liabilities, commitments and contigencies, and stockholders’ deficit

 

$

45,872 

 

$

84,137 





Contact Information

Ellen Tremaine, Investor Relations

646.490.2989

ellen.tremaine@kadmon.com