BSTC BioSpecifics Technologies Corp

51.94
-0.44  -1%
Previous Close 52.38
Open 52.14
52 Week Low 42
52 Week High 69.73
Market Cap $381,496,963
Shares 7,344,955
Float 6,206,130
Enterprise Value $282,650,038
Volume 21,186
Av. Daily Volume 32,290
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
QWO
Edematous fibrosclerotic panniculopathy (“cellulite”)
Approved
Approved
FDA Approval announced July 6, 2020.
XIAFLEX
Uterine fibroids
Phase 1
Phase 1
Phase 1 data released March 2019.
XIAFLEX
Adhesive Capsulitis (“Frozen Shoulder syndrome”)
Phase 2b
Phase 2b
Phase 2b trial did not meet endpoint. Endo is currently performing a commercial assessment.
XIAFLEX
Human lipomas
Phase 2
Phase 2
Phase 2 topline data released June 2016 - endpoints met

Latest News

  1. WILMINGTON, Del., Sept. 14, 2020 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ:BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX® in North America, today announced that Joseph Truitt, Chief Executive Officer, will present at the virtual Oppenheimer & Co. Fall Healthcare Life Sciences and MedTech Summit on Monday, September 21, 2020 at 4:10 p.m. ET.

    A live webcast of the presentations may be accessed by visiting the Events and Presentations section of the BioSpecifics website at https://investors.biospecifics.com.  An archived replay of the webcast will be available on the Company's website for approximately 90 days following the presentation.

    About BioSpecifics Technologies Corp.

    BioSpecifics Technologies Corp. is a commercial-stage biopharmaceutical company. The Company discovered and developed a proprietary form of injectable collagenase (CCH), which is currently marketed by the Company's partner, Endo International plc (Endo), as XIAFLEX® in North America for the treatment of Dupuytren's contracture and Peyronie's disease. Endo announced that it received FDA approval of CCH for the treatment of moderate to severe cellulite in the buttocks of adult women; Qwo™ is expected to be available commercially in the U.S. starting in the first half of 2021.  The CCH research and development pipeline includes several additional potential indications including adhesive capsulitis and plantar fibromatosis. For more information, please visit www.biospecifics.com.

    Forward-Looking Statements 

    This press release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company's strategy, future operations, projected prospects, plans and objectives of management, future strategic opportunities, the effect of recent management and board leadership changes, the timing and occurrence of commercial launches, potential indications, research and development plans, indications in development, and the assumptions underlying or relating to such statements, are "forward-looking statements." In some cases, these statements can be identified by forward-looking words such as "expect," "plan," "anticipate," "potential," "estimate," "can," "will," "continue," "believe," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on the Company's current expectations and the Company's projections about future events and various assumptions. There can be no assurance that the Company will realize its expectations or that the Company's beliefs will prove correct. There are a number of important factors that could cause the Company's actual results to differ materially from those indicated by such forward-looking statements, including, but not limited to: the timing of regulatory filings and action; the ability of Endo to achieve its objectives for XIAFLEX®  and Qwo™; the market for XIAFLEX®  in, and timing, initiation, and outcome of clinical trials for, additional indications, which will determine the amount of milestone, royalty, mark-up on cost of goods sold, license, and sublicense income that the Company may receive; the potential of XIAFLEX® to be used in additional indications; Endo modifying its objectives or allocating resources other than to XIAFLEX® and Qwo™; the impacts of the novel coronavirus (COVID-19) global pandemic; and other risk factors identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, and  otherwise in its filings and reports filed with the Securities and Exchange Commission. All forward-looking statements included in this press release are made as of the date hereof, are expressly qualified in their entirety by the cautionary statements included in this press release and, except as may be required by law, the Company assumes no obligation to update these forward-looking statements.

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  2. WILMINGTON, Del., Sept. 8, 2020 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ:BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX® in North America, today announced that Joseph Truitt, Chief Executive Officer, will present at the H.C. Wainwright Virtual Healthcare Conference on Monday, September 14, 2020 at 3:00 p.m. ET.

    A live webcast of the presentations may be accessed by visiting the Events and Presentations section of the BioSpecifics website at https://investors.biospecifics.com.  An archived replay of the webcast will be available on the Company's website for approximately 90 days following the presentation.

    About BioSpecifics Technologies Corp.

    BioSpecifics Technologies Corp. is a commercial-stage biopharmaceutical company. The Company discovered and developed a proprietary form of injectable collagenase (CCH), which is currently marketed by the Company's partner, Endo International plc (Endo), as XIAFLEX® in North America for the treatment of Dupuytren's contracture and Peyronie's disease. Endo announced that it received FDA approval of CCH for the treatment of moderate to severe cellulite in the buttocks of adult women; Qwo™ is expected to be available commercially in the U.S. starting in the first half of 2021.  The CCH research and development pipeline includes several additional potential indications including adhesive capsulitis and plantar fibromatosis. For more information, please visit www.biospecifics.com.

    Forward-Looking Statements 

    This press release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company's strategy, future operations, projected prospects, plans and objectives of management, future strategic opportunities, the effect of recent management and board leadership changes, the timing and occurrence of commercial launches, potential indications, research and development plans, indications in development, and the assumptions underlying or relating to such statements, are "forward-looking statements." In some cases, these statements can be identified by forward-looking words such as "expect," "plan," "anticipate," "potential," "estimate," "can," "will," "continue," "believe," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on the Company's current expectations and the Company's projections about future events and various assumptions. There can be no assurance that the Company will realize its expectations or that the Company's beliefs will prove correct. There are a number of important factors that could cause the Company's actual results to differ materially from those indicated by such forward-looking statements, including, but not limited to: the timing of regulatory filings and action; the ability of Endo to achieve its objectives for XIAFLEX®  and Qwo™; the market for XIAFLEX®  in, and timing, initiation, and outcome of clinical trials for, additional indications, which will determine the amount of milestone, royalty, mark-up on cost of goods sold, license, and sublicense income that the Company may receive; the potential of XIAFLEX® to be used in additional indications; Endo modifying its objectives or allocating resources other than to XIAFLEX® and Qwo™; the impacts of the novel coronavirus (COVID-19) global pandemic; and other risk factors identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, and  otherwise in its filings and reports filed with the Securities and Exchange Commission. All forward-looking statements included in this press release are made as of the date hereof, are expressly qualified in their entirety by the cautionary statements included in this press release and, except as may be required by law, the Company assumes no obligation to update these forward-looking statements.

    IR Contact:

    Stern Investor Relations, Inc.

    Sarah McCabe

     

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  3. WILMINGTON, Del., Aug. 10, 2020 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ:BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX® in North America, today announced its financial results for the second quarter ended June 30, 2020.

    "While we anticipated an impact on second quarter 2020 royalty revenue due to COVID-19, our cash position remains strong, and we are projecting a rebound in XIAFLEX® royalties in the second half of 2020. With the recent addition of Alex Monteith as our CBO, the approval of Qwo™, or CCH-aaes, by the FDA and the initiation of patient dosing for XIAFLEX® in plantar fibromatosis and adhesive capsulitis, we are well positioned to continue to execute on our strategic initiatives of expanding the uses of the XIAFLEX platform and adding additional assets to the BioSpecifics portfolio," said Joseph Truitt, Chief Executive Officer of BioSpecifics.

    Second Quarter 2020 Financial Results

    As of June 30, 2020, BioSpecifics had cash and cash equivalents and investments of $119.8 million, compared to $105.8 million as of December 31, 2019.

    BioSpecifics reported GAAP net income of $0.1 million for the second quarter ended June 30, 2020, or $0.02 per basic share and $0.02 per share on a fully diluted basis, compared to GAAP net income of $6.4 million, or $0.88 per basic share and $0.87 per share on a fully diluted basis, for the same period in 2019.

    BioSpecifics reported non-GAAP net income of $0.8 million for the second quarter ended June 30, 2020, or $0.11 per basic share and $0.11 per share on a fully diluted basis, compared to non-GAAP net income of $6.5 million, or $0.89 per basic share and $0.89 per share on a fully diluted basis, for the same period in 2019.

    Total revenue for the second quarter ended June 30, 2020 was $3.9 million, compared to $8.9 million for the same period in 2019. Revenues decreased 56% year-over-year in the second quarter ended June 30, 2020, and 60% from the first quarter ended March 31, 2020, due to the impacts of the COVID-19 pandemic, including, without limitation, the effect of significant office closures and less office visits for physician-administered products.

    GAAP research and development expenses were $0.2 million for both the second quarter ended June 30, 2020 and for the same period in 2019. Non-GAAP research and development expenses for the second quarter ended June 30, 2020 were $0.1 million, compared to $0.2 million for the same period in 2019.

    GAAP general and administrative expenses for the second quarter ended June 30, 2020 were $4.0 million, compared to $1.7 million for the same period in 2019. Non-GAAP general and administrative expenses for the second quarter ended June 30, 2020 were $3.2 million, compared to $1.6 million for the same period in 2019.

    Provision for income taxes for the second quarter ended June 30, 2020 were $24,000, compared to $1.1 million for the same period in 2019.

    As of June 30, 2020, BioSpecifics had 7,344,955 shares of common stock outstanding.

    XIAFLEX® Franchise Highlights

    • BioSpecifics' royalty revenues from the XIAFLEX® commercial franchise down 56% year-over-year: Royalty revenue from XIAFLEX® for the second quarter was down as a result of the impacts of the COVID-19 pandemic, including, without limitation, physician office closures and a decline in patients electing to be treated. Endo expects quarter-over-quarter revenue growth in the third quarter of 2020 to be in the mid to high 40 percent range as physician and patient activities continue returning toward pre-COVID-19 levels.
    • Qwo™ (collagenase clostridium histolyticum-aaes), the first and only U.S Food and Drug Administration (FDA)-approved injectable treatment for cellulite: In July 2020, CCH-aaes was approved by the FDA for the treatment of cellulite. Endo's commercial launch is expected to occur in the first half of 2021.
    • New studies for plantar fibromatosis and adhesive capsulitis initiated in June and July 2020, respectively: Endo dosed the first patient in a clinical trial in plantar fibromatosis in June 2020 and adhesive capsulitis in July 2020. Plantar fibromatosis is a non-malignant thickening of the feet's deep connective tissue or fascia that occurs in five to 11 percent of the adult population in the U.S. Adhesive capsulitis, also known as frozen shoulder, is an inflammation and thickening of the shoulder capsule due to collagen which causes decreased motion in the shoulder that occurs in two to five percent of the adult population in the U.S. There are currently no FDA-approved pharmaceutical therapies available to treat either condition.

    Corporate Highlights

    • Alex Monteith appointed Chief Business Officer: In July 2020, BioSpecifics announced the appointment of Alex Monteith as Senior Vice President and Chief Business Officer. Mr. Monteith has extensive business development experience and industry knowledge, and last served as Vice President of Business Development for Deerfield Management, LLC.

    Non-GAAP Financial Information

    This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per share, non-GAAP research and development expense, and non-GAAP general and administrative expense, because such measures exclude stock-based compensation, restructuring expense and separation costs.

    These measures supplement BioSpecifics' financial results prepared in accordance with GAAP. BioSpecifics utilizes these financial measures, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. Additionally, the Company believes that non-GAAP financial measures will be used by certain investors to measure the Company's operating results. In management's opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance of BioSpecifics and its future outlook.  Such measures should not be deemed to be an alternative to GAAP requirements or a measure of BioSpecifics' liquidity. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures.

    About BioSpecifics Technologies Corp.

    BioSpecifics Technologies Corp. is a commercial-stage biopharmaceutical company that discovered and developed a proprietary form of injectable collagenase (CCH), which is currently marketed by the Company's partner, Endo International plc (Endo), as XIAFLEX® in North America for the treatment of Dupuytren's contracture and Peyronie's disease. Following U.S. Food and Drug Administration approval of CCH-aaes for the treatment of moderate to severe cellulite in the buttocks of adult woman in July 2020, Endo expects Qwo™ to be commercially available in the first half of 2021. The XIAFLEX® research and development pipeline includes several additional potential indications including adhesive capsulitis and plantar fibromatosis, which are currently in clinical development by Endo. For more information, please visit www.biospecifics.com.

    Forward-Looking Statements 

    This press release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, and objectives of management, shareholder value, the effect of recent management leadership changes, the timing and occurrence of commercial launches, potential indications, research and development plans, indications in development, and the assumptions underlying or relating to such statements, are "forward-looking statements." These forward-looking statements include statements regarding the commercial launch of CCH-aaes for the treatment of cellulite, as well as the impacts of the novel coronavirus (COVID-19) global pandemic. In some cases, these statements can be identified by forward-looking words such as "expect," "plan," "anticipate," "potential," "estimate," "can," "will," "continue," "believe," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on our current expectations and our projections about future events and various assumptions. There can be no assurance that we will realize our expectations or that our beliefs will prove correct. There are a number of important factors that could cause the Company's actual results to differ materially from those indicated by such forward-looking statements, including, but not limited to: the timing of regulatory filings and action; the ability of Endo to achieve its objectives for XIAFLEX® and Qwo™; the market for XIAFLEX® in, and timing, initiation, and outcome of clinical trials for, additional indications, which will determine the amount of milestone, royalty, mark-up on cost of goods sold, license, and sublicense income that the Company may receive; the potential of XIAFLEX® to be used in additional indications; Endo modifying its objectives or allocating resources other than to XIAFLEX® and Qwo™; the impacts of the novel coronavirus (COVID-19) global pandemic; and other risk factors identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, and otherwise in its filings and reports filed with the Securities and Exchange Commission. All forward-looking statements included in this press release are made as of the date hereof, are expressly qualified in their entirety by the cautionary statements included in this press release and, except as may be required by law, the Company assumes no obligation to update these forward-looking statements.

    BioSpecifics Technologies Corporation

    and Subsidiaries

    Consolidated Statements of Operations

    (unaudited)



















    Three months ended



    Six months ended



    June 30



    June 30



    2020



    2019



    2020



    2019

    Revenues:















         Royalties

    $  3,903,402



    $    8,852,986



    $13,572,069



    $16,982,127

            Total revenues

    3,903,402



    8,852,986



    13,572,069



    16,982,127

















    Costs and expenses:















         Research and development

    160,461



    161,321



    282,431



    310,857

         General and administrative

    3,993,861



    1,728,125



    7,161,907



    4,635,284

         Restructuring expense

    -



    -



    1,146,045



    -

            Total cost and expenses

    4,154,322



    1,889,446



    8,590,383



    4,946,141

















    Operating income

    (250,920)



    6,963,540



    4,981,686



    12,035,986

















    Other income:















          Interest Income

    390,888



    517,156



    870,597



    966,580

















    Income before income tax expense

    139,968



    7,480,696



    5,852,283



    13,002,566

         Provision for income tax expense

    (24,172)



    (1,054,236)



    (1,237,681)



    (2,159,511)

















    Net income

    $     115,796



    $    6,426,460



    $  4,614,602



    $10,843,055

















































    Basic net income per share

    $          0.02



    $            0.88



    $          0.63



    $          1.49

















    Diluted net income per share

    $          0.02



    $            0.87



    $          0.63



    $          1.48

































    Shares used in computation of basic net income per share

    7,337,460



    7,308,268



    7,337,564



    7,292,663

















    Shares used in computation of diluted net income per share

    7,361,764



    7,349,696



    7,361,256



    7,344,008

     

    BioSpecifics Technologies Corporation

    and Subsidiaries

    Reconciliation of GAAP to Non-GAAP Financial Information

    (unaudited)



















    Three months ended



    Six months ended



    June 30



    June 30



    2020



    2019



    2020



    2019

















    GAAP net income

    $     115,796



    $    6,426,460



    $  4,614,602



    $10,843,055

















    Non-GAAP adjustments:















         Stock-based compensation

    162,464



    118,678



    472,338



    260,466

         Restructuring expense (1)

    -



    -



    1,146,045



    -

         Separation costs

    672,025



    -



    672,025



    290,439

         Tax effect of adjustments

    (144,116)



    (16,722)



    (484,421)



    (91,505)

















    Non-GAAP net income

    $     806,168



    $    6,528,416



    $  6,420,588



    $11,302,455

















































    Basic net income per share

    $          0.11



    $            0.89



    $          0.88



    $          1.55

















    Diluted net income per share

    $          0.11



    $            0.89



    $          0.87



    $          1.54

































    Shares used in computation of basic net income per share

    7,337,460



    7,308,268



    7,337,564



    7,292,663

















    Shares used in computation of diluted net income per share

    7,361,764



    7,349,696



    7,361,256



    7,344,008

















    Notes to the Reconciliation of GAAP to Non-GAAP Financial Information:

    (1) Restructuring expense includes $190,433 of stock-based compensation expense.

















    Research and development expense reconciliation:















    GAAP research and development expenses

    $     160,461



    $       161,321



    $     282,431



    $     310,857

      Separation costs

    (31,053)



    -



    (31,053)



    -

    Non-GAAP research and development expenses

    $     129,408



    $       161,321



    $     251,378



    $     310,857

















    General and Administrative expense reconciliation:















    GAAP general and administrative expenses

    $  3,993,861



    $    1,728,125



    $  7,161,907



    $  4,635,284

      Stock-based compensation

    (162,464)



    (118,678)



    (472,338)



    (260,466)

      Separation costs

    (640,972)



    -



    (640,972)



    (290,439)

    Non-GAAP general and administrative expenses

    $  3,190,425



    $    1,609,447



    $  6,048,597



    $  4,084,379

     

    BioSpecifics Technologies Corp.

    Selected Condensed Consolidated Balance Sheet Data





    (Unaudited)









    June 30,



    December 31,





    2020



    2019 (1)



    Cash and cash equivalents

    $16,871,522



    $    4,999,183



    Investments

    102,972,062



    100,808,942



    Accounts receivable

    11,696,598



    19,065,919



    Working capital

    108,217,625



    107,848,984



    Total assets

    133,781,785



    126,653,268



    Deferred tax liabilities

    395,858



    572,660



    Total stockholders' equity

    129,417,438



    124,491,102























    (1)The selected consolidated balance sheet information for the year ended December 31, 2019 have been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

     

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  4. WILMINGTON, Del., July 20, 2020 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ:BSTC) (the "Company"), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX® in North America, today announced the appointment of Alex Monteith as Senior Vice President and Chief Business Officer.

    "As we seek to execute our corporate strategy, including exploring the potential of new XIAFLEX® indications and expanding our portfolio beyond our existing assets, I am confident that Alex's extensive business development experience and strategic insights will prove invaluable in the next stage of our growth," said Joe Truitt, Chief Executive Officer.

    Mr. Monteith was most recently Vice President of Business Development for Deerfield Management, LLC, where he helped establish and lead the business development function as part of the Operations Team. Previously, he served as Vice President of Business Development & Alliance Management for Achillion Pharmaceuticals, Inc. ("Achillion"), a clinical-stage biopharmaceutical company. Prior to Achillion, he was the Head of U.S. Business Development for Helsinn Therapeutics, Inc. and held a number of other business development roles at Signum Biosciences, Inc., Alpharma Pharmaceuticals, LLC, and UCB, Inc. Mr. Monteith began his pharma career at Merck & Co., Inc.as a chemist, and later held positions in finance. He holds an M.B.A. from Carnegie Mellon University and a B.S. in Biology from James Madison University.

    About BioSpecifics Technologies Corp.

    BioSpecifics Technologies Corp. is a commercial-stage biopharmaceutical company. The Company discovered and developed a proprietary form of injectable collagenase (CCH), which is currently marketed by the Company's partner, Endo International plc (Endo), as XIAFLEX® in North America for the treatment of Dupuytren's contracture and Peyronie's disease. Endo announced that it received FDA approval of CCH for the treatment of moderate to severe cellulite in the buttocks of adult women; Qwo™ is expected to be available commercially in the U.S. starting in the first half of 2021.  The CCH research and development pipeline includes several additional potential indications including adhesive capsulitis and plantar fibromatosis. For more information, please visit www.biospecifics.com.

    Forward-Looking Statements 

    This press release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company's strategy, future operations, projected prospects, plans and objectives of management, future strategic opportunities, the effect of recent management and board leadership changes, the timing and occurrence of commercial launches, potential indications, research and development plans, indications in development, and the assumptions underlying or relating to such statements, are "forward-looking statements." In some cases, these statements can be identified by forward-looking words such as "expect," "plan," "anticipate," "potential," "estimate," "can," "will," "continue," "believe," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on the Company's current expectations and the Company's projections about future events and various assumptions. There can be no assurance that the Company will realize its expectations or that the Company's beliefs will prove correct. There are a number of important factors that could cause the Company's actual results to differ materially from those indicated by such forward-looking statements, including, but not limited to: the timing of regulatory filings and action; the ability of Endo to achieve its objectives for XIAFLEX®  and Qwo™; the market for XIAFLEX®  in, and timing, initiation, and outcome of clinical trials for, additional indications, which will determine the amount of milestone, royalty, mark-up on cost of goods sold, license, and sublicense income that the Company may receive; the potential of XIAFLEX® to be used in additional indications; Endo modifying its objectives or allocating resources other than to XIAFLEX® and Qwo™; the impacts of the novel coronavirus (COVID-19) global pandemic; and other risk factors identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, and  otherwise in its filings and reports filed with the Securities and Exchange Commission. All forward-looking statements included in this press release are made as of the date hereof, are expressly qualified in their entirety by the cautionary statements included in this press release and, except as may be required by law, the Company assumes no obligation to update these forward-looking statements.

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  5. WILIMINGTON, Del., May 11, 2020 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ:BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX® in North America, today announced its financial results for the first quarter ended March 31, 2020.  

    "Our royalty revenue from XIALFLEX® was up 19% over last year, and while XIAFLEX® had a strong first quarter of 2020, we expect to start to see an impact from COVID-19 in the second quarter due to office closures and patients not electing to be treated. While we don't yet know the far reaching implications of this pandemic, the focus remains on patients and how they can best be served by XIAFLEX® and the future potential of the CCH development pipeline," said Joseph Truitt, Chief Executive Officer of BioSpecifics. "In my new role as CEO, I am very confident in the deep value of the company and the many growth opportunities and I look forward to building an even greater future for BioSpecifics."

    First Quarter 2020 Financial Results
    BioSpecifics reported net income of $4.5 million for the first quarter ended March 31, 2020, or $0.61 per basic share and $0.61 per share on a fully diluted basis, compared to net income of $4.4 million, or $0.61 per basic share and $0.60 per share on a fully diluted basis, for the same period in 2019.

    Total revenue for the first quarter ended March 31, 2020 was $9.7 million, compared to $8.1 million for the same period in 2019. The increase in total revenues for the quarterly period was primarily due to increased royalties from sales of both Peyronie's disease and Dupuytren's contracture.

    Research and development expenses for the first quarter ended March 31, 2020 were $0.1 million compared to $0.1 million for the same period in 2019.

    General and administrative expenses for the first quarter ended March 31, 2020 were $3.2 million, compared to $2.9 million for the same period in 2019.

    Restructuring charges related to the relocation of the Company's headquarters and the separation of certain employees were $1.1 million for the first quarter ended March 31, 2020.

    Provision for income taxes for the first quarter ended March 31, 2020 were $1.2 million, compared to $1.1 million for the same period in 2019.

    As of March 31, 2020, BioSpecifics had cash and cash equivalents and investments of $113.6 million, compared to $105.8 million as of December 31, 2019.

    As of March 31, 2020, BioSpecifics had 7,337,511 shares of common stock outstanding.

    Collagenase Clostridium Histolyticum (CCH) Commercial & Pipeline Highlights

    • BioSpecifics' royalty revenues from the XIAFLEX® commercial franchise grew by 19% year-over-year: XIAFLEX® royalty revenue growth was attributable to royalties associated with higher net sales of XIAFLEX® by BioSpecifics' partner Endo International plc (Endo), for Dupuytren's contracture and Peyronie's disease.
    • Endo's Biologics License Application (BLA) filing for CCH for the treatment of cellulite under U.S. Food and Drug Administration (FDA) review: The Prescription Drug User Fee Act (PDUFA) date for CCH for the treatment of cellulite is July 6, 2020. Endo's anticipated commercial launch has been delayed in connection with the impacts of COVID-19, and is now expected to occur in the first quarter of 2021.
    • Initiation of CCH studies for plantar fibromatosis and adhesive capsulitis in second half of 2020: Endo expects to initiate clinical trials in adhesive capsulitis and plantar fibromatosis in the second half of 2020. Adhesive capsulitis, also known as frozen shoulder, is an inflammation and thickening of the shoulder capsule due to collagen which causes decreased motion in the shoulder. Plantar fibromatosis is a non-malignant thickening of the feet's deep connective tissue or fascia. There are currently no FDA-approved pharmaceutical therapies available to treat either condition.

    Recent Corporate Highlights

    • Joseph Truitt appointed Chief Executive Officer: Today, BioSpecifics announced the appointment of Joseph Truitt as Chief Executive Officer. Mr. Truitt has a strong track record of clinical, commercial and operational leadership. Mr. Truitt had served as the Company's interim Chief Executive Officer since April 6, 2020.
    • Strengthened the Board of Directors with new independent directors Mike Sherman and Corey Fishman: In April 2020, BioSpecifics announced the appointments of Mike Sherman and Corey Fishman to the Board of Directors. Mr. Sherman serves on the Audit Committee and as financial expert, and also on the Strategy Committee and Corey serves on the Audit Committee and as Chair of the Strategy Committee. Mr. Sherman is currently Chief Executive Officer of Chimerix, Inc. Mr. Fishman has served as Chief Executive Officer and Director of Iterum Therapeutics plc, since he founded the company in 2015.

    Anticipated Impact of COVID-19

    • XIAFLEX® revenues are expected to decline in the second quarter of 2020 due to significant office closures and less office visits for physician-administered products.
      • Endo expects to see a gradual increase in demand beginning in the second half of 2020.
    • Full year 2020 XIAFLEX® revenues are expected to be lower than full year revenues in 2019.
    • The Company's partner, Endo, has withdrawn its financial guidance for 2020.
    • Endo's anticipated commercial launch for CCH for cellulite, pending FDA approval, is now expected in the first quarter of 2021. This delay decision was made in connection with the anticipated impact of COVID-19 on medical aesthetics physician office closures and decreased consumer spending.
    • Endo currently anticipates modest delays in patient recruitment and site selection for new clinical trials and ongoing studies.

    About BioSpecifics Technologies Corp.
    BioSpecifics Technologies Corp. is a commercial-stage biopharmaceutical company. The Company discovered and developed a proprietary form of injectable collagenase (CCH) which is currently marketed by BioSpecifics' partner, Endo International plc (Endo), as XIAFLEX® in North America for the treatment of Dupuytren's contracture and Peyronie's disease. Endo expects a commercial launch in the first quarter of 2021 for a third CCH indication, cellulite, subject to U.S. Food and Drug Administration approval, which is expected in the second half of 2020. The CCH research and development pipeline includes several additional potential indications; adhesive capsulitis, plantar fibromatosis and uterine fibroids. For more information, please visit www.biospecifics.com.

    Forward-Looking Statements 
    This report includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, and objectives of management, shareholder value, the effect of recent management and board leadership changes, and the assumptions underlying or relating to such statements, are "forward-looking statements." These forward-looking statements include statements regarding the timing of, the approval by the FDA, and the commercial launch of CCH for the treatment of cellulite, as well as the impacts of the novel coronavirus (COVID-19) global pandemic. In some cases, these statements can be identified by forward-looking words such as "expect," "plan," "anticipate," "potential," "estimate," "can," "will," "continue," "believe," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on our current expectations and our projections about future events and various assumptions. There can be no assurance that we will realize our expectations or that our beliefs will prove correct. There are a number of important factors that could cause BioSpecifics' actual results to differ materially from those indicated by such forward-looking statements, including, but not limited to: the timing of regulatory filings and action; the ability of Endo and its partners to achieve their objectives for XIAFLEX® in their applicable territories; the market for XIAFLEX® in, and timing, initiation, and outcome of clinical trials for, additional indications, which will determine the amount of milestone, royalty, mark-up on cost of goods sold, license, and sublicense income that BioSpecifics may receive; the potential of XIAFLEX® to be used in additional indications; Endo modifying its objectives or allocating resources other than to XIAFLEX®; the strength of BioSpecifics' intellectual property portfolio; and other risk factors identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 (the "2019 Annual Report"), specifically in Part I, Item IA under the heading "Risk Factors" of the 2019 Annual Report and risk factors identified in our other filings with the Securities and Exchange Commission. All forward-looking statements included in this report are made as of the date hereof, are expressly qualified in their entirety by the cautionary statements included in this report and, except as may be required by law, we assume no obligation to update these forward-looking statements.

    BioSpecifics Technologies Corp.



    Condensed Consolidated Income Statement





    (Unaudited)






















    Three months ended







    March 31,







    2020


    2019







    Revenues:











       Royalties


    $    9,668,667


    $     8,129,141







            Total Revenues


    9,668,667


    8,129,141


















    Costs and expenses:











       Research and development


    121,970


    149,536







       General and administrative


    3,168,046


    2,907,160







       Restructuring expense


    1,146,045


    -







            Total costs and expenses


    4,436,061


    3,056,696


















    Operating income


    5,232,606


    5,072,445


















    Other income:











       Interest income


    479,709


    449,425









    479,709


    449,425


















    Income before income tax expense


    5,712,315


    5,521,870







    Provision for income tax expense


    (1,213,509)


    (1,105,275)


















    Net income


    4,498,806


    4,416,595


















    Earnings per share:











    Basic


    $             0.61


    $               0.61







    Diluted


    $             0.61


    $               0.60


















    Shares used in calculation of earnings per share:











    Basic


    7,337,368


    7,276,885







    Diluted


    7,361,533


    7,338,128








































    BioSpecifics Technologies Corp.





    Selected Condensed Consolidated Balance Sheet Data














    (Unaudited)











    March 31,


    December 31,









    2020


    2019 (1)





    Cash and cash equivalents




    $    19,134,304


    $     4,999,183





    Investments




    94,470,647


    100,808,942





    Accounts receivable




    17,750,829


    19,065,919





    Working capital




    119,522,031


    107,848,984





    Total assets




    133,246,787


    126,653,268





    Deferred tax liabilities




    484,259


    572,660





    Total stockholders' equity




    129,269,183


    124,491,102



























    (1)The selected consolidated balance sheet information for the year ended December 31, 2019 have been derived from the audited
    financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in
    the United States for complete financial statements.



     

     

     

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