Xencor, MorphoSys and Incyte Enter into Global Development Collaboration for Tafasitamab in Combination with Plamotamab

Xencor, MorphoSys and Incyte Enter into Global Development Collaboration for Tafasitamab in Combination with Plamotamab

MONROVIA, Calif. & PLANEGG/MUNICH, Germany & WILMINGTON, Del.–(BUSINESS WIRE)–
Xencor (NASDAQ: XNCR), MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and Incyte (NASDAQ: INCY) today announced a clinical collaboration to investigate the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL, and relapsed or refractory follicular lymphoma (FL).

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‟Xencor is pleased to partner with MorphoSys and Incyte to advance the development of plamotamab, our CD20 x CD3 XmAb® bispecific antibody that has demonstrated encouraging clinical activity as a monotherapy in non-Hodgkin lymphoma,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Plamotamab, which redirects T cells to tumors, and tafasitamab, a CD19-directed XmAb antibody, combine powerful and distinct immune pathways, and this collaboration is designed to enable us to generate new clinical insights and accelerate development timelines for patients who may need additional therapeutic options. It builds upon many years of partnership between Xencor and MorphoSys following MorphoSys’ in-licensing of tafasitamab in 2010.”

‟Tafasitamab in combination with lenalidomide is an important new relapsed/refractory DLBCL treatment option for appropriate patients in the United States today, and its mechanism of action, efficacy and safety profile make it an attractive combination partner,” said Jean-Paul Kress, M.D., chief executive officer of MorphoSys. “We believe that tafasitamab as a backbone can add value to new combinations such as with CD20 x CD3 bispecifics, and we are excited about this collaboration with Xencor and Incyte aiming to help more patients in areas of unmet need.”

‟This collaboration has the potential to advance patient care and Incyte is proud to join Xencor and MorphoSys in evaluating this new combination approach for these serious cancers,” said Hervé Hoppenot, chief executive officer of Incyte.

Xencor’s plamotamab is a tumor-targeted bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). Tafasitamab is MorphoSys’ CD19-directed antibody which was recently approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Under the terms of the agreement, the companies plan to initiate a Phase 1/2 study evaluating the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory DLBCL. Additionally, the companies are planning to evaluate the combination in relapsed or refractory FL and first-line DLBCL in multiple Phase 1b studies. MorphoSys and Incyte will provide tafasitamab for the studies, which will be sponsored and funded by Xencor and are planned to be conducted in North America, Europe and Asia-Pacific.

The collaboration is effective immediately upon the execution of the agreement.

About Plamotamab (XmAb®13676)

Plamotamab (XmAb®13676) is a tumor-targeted bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3), which is currently in a Phase 1 clinical study for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). An XmAb Bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on plamotamab. CD20 is highly expressed on B-cell tumors, including NHL and CLL. Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi® is a registered trademark of MorphoSys AG.

XmAb® is a registered trademark of Xencor, Inc.

About Xencor

Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases. Currently, 18 candidates engineered with Xencor’s XmAb® technology are in clinical development internally and with partners. Xencor’s XmAb antibody engineering technology enables small changes to the structure of monoclonal antibodies resulting in new mechanisms of therapeutic action. For more information, please visit www.xencor.com.

About MorphoSys

MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya®, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys’ proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com or www.morphosys-us.com.

Monjuvi® is a registered trademark of MorphoSys AG.

Tremfya® is a registered trademark of Janssen Biotech, Inc.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

Xencor Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of applicable securities laws, including, but not limited to, the quotations from Xencor’s president and chief executive officer; the outcome of the collaboration with MorphoSys and Incyte, including the ability of the collaboration to generate new clinical insights, accelerate development timelines and advance patient care; the ability of the proposed combination treatment to improve response rates and address more patients in areas of unmet need; and the timing and success of the Phase 1/2 study and multiple Phase 1b studies contemplated by the agreement. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor’s public securities filings. For a discussion of these and other factors, please refer to Xencor’s annual report on Form 10-K for the year ended December 31, 2019 as well as Xencor’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements are based on Xencor’s current information and belief as well as assumptions made by Xencor. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

MorphoSys Forward-Looking Statements

This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi’s ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would,” “could,” “potential,” “possible,” “hope” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys’ expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys’ business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys’ ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys’ reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys’ Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

Incyte Forward-looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding expectations regarding Monjuvi’s ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, and the development of tafasitamab-cxix in combination with plamotamab, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by regulatory authorities; the efficacy or safety of Incyte’s or its collaborators’ products; the acceptance of Incyte’s products and the products of its collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2020. Incyte disclaims any intent or obligation to update these forward-looking statements.

Xencor, Inc.

Charles Liles

[email protected]

Jason I. Spark

Canale Communications

Tel: +1 619-849-6005

[email protected]

MorphoSys AG

Media Contacts:

Jeanette Bressi

Director, US Communications

Tel: +1 617-404-7816

[email protected]

Sophie Petersen

Senior Specialist

Tel: +49 (0)89 / 899 27 26033

[email protected]

Investor Contact:

Dr. Julia Neugebauer

Director

Tel: +49 (0)89 / 899 27 179

[email protected]

Incyte Corporation

Catalina Loveman

Executive Director, Public Affairs

Tel: +1 302 498 6171

[email protected]

Dr. Michael Booth

Division Vice President, Investor Relations & Corporate Responsibility

Tel: +1 302 498 5914

[email protected]

Christine Chiou

Senior Director, Investor Relations

Tel: +1 302 274 4773

[email protected]

KEYWORDS: California Delaware Germany Europe United States North America

INDUSTRY KEYWORDS: Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology

MEDIA:

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Green Thumb Industries Reports Revenue of $157.1 Million and Positive Net Income of $9.6 Million or $0.04 Per Share for Third Quarter 2020

  • Adjusted
    Operating
    EBITDA increased 50
    .2
    % to $53
    .2
    million
    ,
    or 3
    3.9
    % of revenue
    ,
    quarter-over-quarter driven by continued operational scale and increased operating leverage
  • R
    evenue
    increased
    31
    .3
    % quarter-over-quarter and 1
    31
    .1
    % year-over-year
    to $157
    .1
    million
  • N
    ew milestone of positive net income of $
    9.6
    million or $0.0
    4
    per basic and diluted share
  • P
    ositive cash flow from operations
    for the
    third consecutive
    quarter
  • Strong balance sheet and financial flexibility
    will
    support
    continued growth
    in 2021

CHICAGO and VANCOUVER, British Columbia, Nov. 11, 2020 (GLOBE NEWSWIRE) — Green Thumb Industries Inc. (“Green Thumb,” or the “Company”) (CSE: GTII) (OTCQX: GTBIF), a leading national cannabis consumer packaged goods company and owner of Rise™ retail stores, today reported its financial results for the third quarter ended September 30, 2020. Financial results are reported in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and all currency is in U.S. dollars.

“This was an excellent quarter for Green Thumb as we delivered substantial revenue growth and our ‘Enter, Open, Scale’ strategy is generating meaningful operating leverage across our business. We expanded gross margins and EBITDA margins quarter-over-quarter while delivering positive net income for the first time. This was driven by the execution of our capital projects in Illinois, New Jersey, Pennsylvania and Ohio, and the rebound in our Nevada and Massachusetts markets following the initial impact of COVID-19. We are poised to further benefit from the strong tailwinds driving a robust, multi-billion-dollar marketplace*,” said Green Thumb Chairman, Founder and Chief Executive Officer Ben Kovler.

Kovler continued, “Momentum remains strong across the country and in our business. The national election saw a green wave sweep across the country with five states – New Jersey, Montana, South Dakota, Arizona and Mississippi – all legalizing their respective cannabis programs. New Jersey is great news for us as we think that legal market has the potential to mirror Illinois – a single state, multi-billion dollar legal cannabis market about to be born. There was resounding support for our mission to promote well-being through cannabis and we remain bullish on our strategic position and the long-term prospects of our business.”

Financial Highlights

  • Revenue: Revenue for the third quarter 2020 increased 31.3% quarter-over-quarter and 131.1% year-over-year to $157.1 million. Revenue growth was driven primarily by the increased scale in the Company’s Consumer Packaged Goods and Retail businesses.
  • Gross Margin: Gross margin for the third quarter 2020 was 55.4% compared to 53.2% for the prior quarter.
  • Net Income
    Attributable to G
    reen Thumb
    : Net income attributable to the Company for the third quarter 2020 was $9.6 million or $0.04 per basic and diluted share.
  • Adjusted Operating
    EBITDA: Adjusted Operating EBITDA(1), which is a non-GAAP financial measure as described below and in an accompanying financial table in this release, increased 50.2% to $53.2 million or 33.9% of revenue for the third quarter 2020 compared to $35.4 million or 29.6% of revenue for the prior quarter.
  • Balance Sheet: As of September 30, 2020, current assets totaled $159.1 million and included cash and cash equivalents of $78.1 million. Total debt outstanding was $97.1 million, $0.3 million of which is due within 12 months. 

    (1) EBITDA refers to earnings before income, taxes, depreciation and amortization. EBITDA and Adjusted Operating EBITDA are non-GAAP financial measures. Please see the “Supplemental Information (Unaudited) Regarding Non-GAAP Financial Measures” at the end of this press release for a reconciliation of non-GAAP to GAAP measures.

Additional Management Commentary

Kovler added, “As we near the close of 2020, Green Thumb is positioned to win. We remain focused on distributing our consumer brands at scale and delivering superior consumer experiences while giving back to our communities. Our focus, along with our strong balance sheet, underlying fundamentals and prudent capital allocation, will continue to provide the flexibility to capitalize on the growth opportunities ahead. We remain laser focused on delivering shareholder value in everything we do.”

Consumer Packaged Goods Business Develo
pment

  • As of September 30, 2020, Green Thumb’s family of consumer brands are produced, distributed, and available in retail locations in eleven states: California, Colorado, Connecticut, Florida, Illinois, Maryland, Massachusetts, Nevada, New Jersey, Ohio and Pennsylvania.
  • Gross branded product sales grew sequentially by approximately 32.6% quarter-over-quarter, driven primarily by expanded product distribution.
  • Green Thumb completed the initial phase of construction of its manufacturing facility in Oglesby, Illinois and began producing and distributing its brand portfolio from that facility during the third quarter. The Company also added branded-product production and distribution capabilities to two new markets, New Jersey and Ohio.
  • Green Thumb continued to develop its brand portfolio with the launch of Snoozzzeberry gummies under the incredibles brand in Illinois and Nevada.

Retail Business Development

  • Green Thumb’s third quarter revenue included sales from 48 retail stores across ten states: Connecticut, Florida, Illinois, Maryland, Massachusetts, Nevada, New Jersey, New York, Ohio and Pennsylvania.
  • Comparable sales growth (stores opened at least 12 months) exceeded 65.0% on a base of 25 stores, driven primarily by increased transactions. Sequential quarter-over-quarter comparable sales were up 17.9% on a base of 42 stores.
  • Retail revenue increased sequentially by 27.9% quarter-over-quarter, primarily driven by increased foot traffic in established stores.
  • Subsequent to the quarter end, in October, Green Thumb expanded retail service in Pennsylvania and Illinois:
    • Pennsylvania: Opened Rise™ Monroeville, bringing total open stores in the state to 13.
    • Illinois: Began adult-use sales in Naperville with the opening of Rise™ Naperville (a rebrand of 3C Compassionate Care Center which previously only serviced registered medical cardholders), the city’s first adult-use cannabis store. The Company has a total of eight open stores in the state with the ability to open two additional stores for a total of ten stores.

Corporate Development

  • Green Thumb announced the launch of the License Education Assistance Program (LEAP) New Business Accelerator, a cannabis business incubator intended to help promote opportunity and success for new social equity entrepreneurs in Illinois.
  • Green Thumb partnered with Last Prisoner Project (“LPP”), a coalition of cannabis industry leaders, executives and artists dedicated to bringing restorative justice to the cannabis industry, on an integrated marketing campaign, including a short documentary (“Waiting to Breathe”) to raise awareness and funds for LPP.

Third
Q
uarter
2020
Financial Overview

Total revenue for the third quarter 2020 was $157.1 million, up 131.1% from $68.0 million for the third quarter 2019, driven by growth from both the Consumer Packaged Goods and Retail businesses, particularly in Illinois and Pennsylvania. Key year-over-year performance drivers were the expanded distribution of Green Thumb’s branded products, 15 new store openings and increased traffic to the Company’s 48 open and operating retail stores.

Gross profit for the third quarter 2020 was $87.0 million or 55.4% of revenue as compared to $32.1 million or 47.3% of revenue for the third quarter 2019.

Total selling, general and administrative expenses for the third quarter were $49.7 million or 31.7% of revenue, as compared to $30.8 million or 45.2% of revenue for the third quarter 2019. Improved operating costs as a percentage of revenue was driven primarily by cost controls and increased operating leverage in the Company’s Consumer Packaged Goods and Retail businesses.

Total other income was $2.0 million for the third quarter 2020 and primarily reflected favorable fair value adjustments on the Company’s equity investments net of interest and warrant expense associated with the Company’s senior secured notes.

EBITDA for the third quarter 2020 was $48.7 million or 31.0% of revenue as compared to $9.1 million or 13.3% of revenue for the third quarter 2019. Adjusted Operating EBITDA for the third quarter 2020, which excluded only non-cash stock-based compensation of $4.4 million, was $53.2 million or 33.9% of revenue as compared to $13.8 million or 20.3% of revenue for the third quarter 2019. The significant improvement in EBITDA and Adjusted Operating EBITDA was driven primarily by revenue growth from both the Consumer Packaged Goods and Retail businesses. For additional information on these non-GAAP financial measures, see below under “Non-GAAP Financial Information.”

Net income attributable to Green Thumb for the third quarter 2020 was $9.6 million or $0.04 per basic and diluted share as compared to a net loss of $14.6 million or ($0.07) per basic and diluted share for the third quarter 2019.

Balance Sheet and Liquidit
y

As of September 30, 2020, current assets were $159.1 million, including cash and cash equivalents of $78.1 million. The Company had $97.1 million of total debt.

Total basic and diluted weighted average shares outstanding for the three months ended September 30, 2020 were 211,990,405 and 214,212,292, respectively.

Capital Markets & Financing

Subsequent to the quarter end, in October Green Thumb amended its previously announced sale and leaseback transaction with Innovative Industrial Properties for its Toledo, Ohio manufacturing facility, securing an additional $25.0 million in funding for the construction of a cultivation facility at the property for total investment value of $32.2 million.

Non-GAAP Financial Information

This press release includes certain non-GAAP financial measures as defined by the SEC. Reconciliations of these non-GAAP financial measures to the most directly comparable financial measure calculated and presented in accordance with GAAP are included in the financial schedules attached to this press release. This information should be considered as supplemental in nature and not as a substitute for, or superior to, any measure of performance prepared in accordance with GAAP.  

*Source: Cowen research report “Cowen’s Cannabis Catalyst Series Part 7 – Alcohol Implications” dated October 22, 2020 estimates the U.S. cannabis total addressable market to reach $100 billion by 2030.

Definition
s

EBITDA
: Earnings before interest, taxes, other income or expense and depreciation and amortization.

Adjusted Operating EBITDA: Earnings before interest, taxes, depreciation, and amortization, adjusted for other income, non-cash share-based compensation, one-time transaction related expenses, or other non-operating costs.

Conference Call and Webcast

Green Thumb will host a conference call on Wednesday, November 11, 2020 at 5:00 pm ET to discuss its financial results for the third quarter ended September 30, 2020. The conference call may be accessed by dialing 833-502-0470 (Toll-Free) or 236-714-2182 (International) with conference ID: 5079863. A live audio webcast of the call will also be available on the Investor Relations section of Green Thumb’s website at https://investors.gtigrows.com and will be archived for replay.

About Green Thumb Industries
:

Green Thumb Industries Inc., a national cannabis consumer packaged goods company and retailer, promotes well-being through the power of cannabis while giving back to the communities in which it serves. Green Thumb manufactures and distributes a portfolio of branded cannabis products including Beboe, Dogwalkers, Dr. Solomon’s, incredibles, Rythm and The Feel Collection. The Company also owns and operates rapidly growing national retail cannabis stores called Rise™ and Essence. Headquartered in Chicago, Illinois, Green Thumb has 13 manufacturing facilities, licenses for 96 retail locations and operations across 12 U.S. markets. Established in 2014, Green Thumb employs over 2,000 people and serves hundreds of thousands of patients and customers each year. The company was named a Best Workplace 2018 by Crain’s Chicago Business and MG Retailer magazine in 2018 and 2019. More information is available at GTIgrows.com.

Cautionary Note Regarding Forward-Looking Information

This press release contains statements that we believe are, or may be considered to be, “forward-looking statements.” All statements other than statements of historical fact included in this document regarding the prospects of our industry or our prospects, plans, financial position or business strategy may constitute forward-looking statements. In addition, forward-looking statements generally can be identified by the use of forward-looking words such as “may,” “will,” “expect,” “intend,” “estimate,” “foresee,” “project,” “anticipate,” “believe,” “plan,” “forecast,” “continue” or “could” or the negative of these terms or variations of them or similar terms. Furthermore, forward-looking statements may be included in various filings that we make with the Securities and Exchange Commission (the “SEC”), or oral statements made by or with the approval of one of our authorized executive officers. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot assure you that these expectations will prove to be correct. These forward-looking statements are subject to certain known and unknown risks and uncertainties, as well as assumptions that could cause actual results to differ materially from those reflected in these forward-looking statements. These known and unknown risks include, without limitation: marijuana remains illegal under federal law, and enforcement of cannabis laws could change; the Company may face limitations on ownership of cannabis licenses; the Company may become subject to U.S. Food and Drug Administration or the U.S. Bureau of Alcohol, Tobacco and Firearms; the Company may face difficulties acquiring additional financing; the Company operates in a highly regulated sector and may not always succeed in complying fully with applicable regulatory requirements in all jurisdictions where we carry on business; the Company is subject to general economic risks; the Company may be negatively impacted by challenging global economic condition
s
; the Company is subject to risks arising from epidemic diseases, such as the recent outbreak of the COVID-19 illness; the Company may face difficulties in enforcing its contracts; the Company is subject to taxation in Canada and the United States; cannabis businesses are subject to unfavorable tax treatment; cannabis businesses may be subject to civil asset forfeiture; the Company is subject to proceeds of crime statutes; the Company faces security risks; our use of joint ventures may expose us to risks associated with jointly owned investments; competition for the acquisition and leasing of properties suitable for the cultivation, production and sale of medical and adult use cannabis may impede our ability to make acquisitions or increase the cost of these acquisitions, which could adversely affect our operating results and financial condition; the Company faces risks related to its products; the Company is dependent on the popularity of consumer acceptance of the Company’s brand portfolio; the Company faces risks related to its insurance coverage and uninsurable risks; the Company is dependent on key inputs, suppliers and skilled labor; the Company must attract and maintain key personnel or our business will fail; the Company’s business is subject to the risks inherent in agricultural operations; the Company’s sales are difficult to forecast; the Company’s products may be subject to product recalls; the Company may face unfavorable publicity or consumer perception;
the Company faces intense competition; the Company’s voting control is concentrated; the Company’s capital structure and voting control may cause unpredictability; and additional issuances of Super Voting Shares, Multiple Voting Shares or Subordinate Voting Shares may result in dilution. Further information on these and other potential factors that could affect the Company’s business and financial condition and the results of operations are included in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, and elsewhere in the Company’s filings with the SEC, which are available on the SEC’s website or at https://investors.gtigrows.com. Readers are cautioned not to place undue reliance on any forward-looking statements contained in this document, which reflect management’s opinions only as of the date hereof. Except as required by law, we undertake no obligation to revise or publicly release the results of any revision to any forward-looking statements. You are advised, however, to consult any additional disclosures we make in our reports to the SEC. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements contained in this document.

Coronavirus Pandemic

In March 2020, the World Health Organization categorized coronavirus disease 2019 (“COVID-19”) as a pandemic. COVID-19 continues to spread throughout the U.S. and other countries across the world, and the duration and severity of its effects are currently unknown. The Company continues to implement and evaluate actions to strengthen its financial position and support the continuity of its business and operations in the face of this pandemic and other events.
The Company’s unaudited interim condensed consolidated financial statements presented herein reflect estimates and assumptions made by management that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited interim condensed consolidated financial statements and reported amounts of revenue and expenses during the periods presented. Such estimates and assumptions affect, among other things, the Company’s goodwill, long-lived asset and intangible assets; operating lease right of use assets and operating lease liabilities; assessment of the annual effective tax rate; valuation of deferred income taxes; the allowance for doubtful accounts; assessment of our lease and non-lease contract expenses; and measurement of compensation cost for bonus and other compensation plans. While
the Company’s
revenue, gross profit and operating income were not impacted during the first
nine
months of 2020, the uncertain nature of the spread of COVID-19 may impact
the Company’s
business operations for reasons including the potential quarantine of
the Company’s
employees or those of
the Company’s
supply chain partners. The estimates and assumptions used in the unaudited interim condensed consolidated financial statements, which include but are not limited to certain judgmental reserves requiring management to makes estimates based on current information, the carrying value of the Company’s goodwill and other long-lived assets, for the three and
nine
months ended
September
30, 2020 may change in future periods as the expected impacts from COVID-19 are revised, resulting in further potential impacts to the Company’s financial statements.

The Canadian Securities Exchange does not accept responsibility for the adequacy or accuracy of this release.

Investor Contact: Media Contact:
   
Jennifer Dooley
Chief Strategy Officer
[email protected]  
310-622-8257
Linda Marsicano
VP, Corporate Communications
[email protected] 
773-354-2004

Source: Green Thumb Industries

 
 
Green Thumb Industries Inc.
Highlights from Unaudited Interim Condensed Consolidated Statements of Operations
Three Months Ended September 30, 2020, June 30, 2020 and September 30, 2019
(Amounts Expressed in United States Dollars, Except for Share Amounts)
             
             
             
    Three Months Ended
    September 30, 2020   June 30, 2020   September 30, 2019
    (Unaudited)   (Unaudited)   (Unaudited)
                         
Revenues, net of discounts   $ 157,103,841     $ 119,639,924     $ 67,990,907  
Cost of Goods Sold, net     (70,146,676 )     (55,946,010 )     (35,849,783 )
                         
Gross Profit     86,957,165       63,693,914       32,141,124  
                         
Expenses:                        
Selling, General, and Administrative     49,745,979       49,643,211       30,764,406  
                         
Total Expenses     49,745,979       49,643,211       30,764,406  
                         
Income (Loss) From Operations     37,211,186       14,050,703       1,376,718  
                         
Other Income (Expense):                        
Other Income (Expense), net     6,432,883       (5,717,427 )     (6,585,540 )
Interest Income, net     5,397       16,410       407,509  
Interest Expense, net     (4,460,125 )     (4,734,908 )     (5,912,290 )
                         
Total Other Income (Expense)     1,978,155       (10,435,925 )     (12,090,321 )
                         
Income (Loss) Before Provision for Income Taxes And Non-Controlling Interest     39,189,341       3,614,778       (10,713,603 )
                         
Provision For Income Taxes     28,436,332       15,378,715       3,624,333  
                         
Net Income (Loss) Before Non-Controlling Interest     10,753,009       (11,763,937 )     (14,337,936 )
                         
Net Income Attributable To Non-Controlling Interest     1,109,080       1,145,568       252,857  
                         
Net Income (Loss) Attributable To Green Thumb Industries Inc.   $ 9,643,929     $ (12,909,505 )   $ (14,590,793 )
                         
Net Income (Loss) per share – basic   $ 0.04     $ (0.06 )   $ (0.07 )
                         
Net Income (Loss) per share – diluted   $ 0.04     $ (0.06 )   $ (0.07 )
                         
Weighted average number of shares outstanding – basic     211,990,405       209,902,732       204,709,085  
                         
Weighted average number of shares outstanding – diluted     214,212,292       209,902,732       204,709,085  
                         

Green Thumb Industries Inc.     
Highlights from Unaudited Interim Condensed Consolidated Balance Sheets    
(Amounts Expressed in United States Dollars)    
         
         
    September 30,   December 31,
     2020    2019
    (Unaudited)   (Unaudited)
             
Cash and Cash Equivalents   $ 78,091,073   $ 46,667,334
Other Current Assets     80,968,164     62,395,277
Property and Equipment, Net     177,725,092     155,596,675
Right of Use Assets, Net     99,447,497     63,647,812
Intangible Assets, Net     409,655,517     435,246,898
Goodwill     373,081,716     375,084,991
Other Long-term Assets     35,645,388     28,897,637
             
Total Assets   $ 1,254,614,447   $ 1,167,536,624
             
Total Current Liabilities   $ 105,898,809   $ 111,367,255
Notes Payable, Net of Current Portion and Debt Discount     96,758,233     91,140,194
Lease Liability, Net of Current Portion     102,408,462     61,115,737
Other long-Term Liabilities     69,472,643     60,704,762
Total Equity     880,076,300     843,208,676
             
Total Liabilities and Equity   $ 1,254,614,447   $ 1,167,536,624
             

Green Thumb Industries Inc.
Supplemental Information (Unaudited) Regarding Non-GAAP Financial Measures
 
 
EBITDA, and Adjusted Operating EBITDA are non-GAAP measures and do not have standardized definitions under GAAP. We define each term as follows:
 
(1) EBITDA is defined as earnings before interest, taxes, other income or expense and depreciation and amortization.
(2) Adjusted Operating EBITDA is defined as earnings before interest, taxes, depreciation, and amortization, adjusted for other income, non-cash share-based compensation, one-time transaction related expenses, or other non-operating costs.
 
The following information provides reconciliations of the supplemental non-GAAP financial measures, presented herein to the most directly comparable financial measures calculated and presented in accordance with GAAP. The Company has provided the non-GAAP financial measures, which are not calculated or presented in accordance with GAAP, as supplemental information and in addition to the financial measures that are calculated and presented in accordance with GAAP. These supplemental non-GAAP financial measures are presented because management has evaluated the financial results both including and excluding the adjusted items and believe that the supplemental non-GAAP financial measures presented provide additional perspective and insights when analyzing the core operating performance of the business. These supplemental non-GAAP financial measures should not be considered superior to, as a substitute for or as an alternative to, and should be considered in conjunction with, the GAAP financial measures presented.
 
 
Adjusted Operating EBITDA
(Amounts Expressed in United States Dollars)
    Three Months Ended


             
    September 30,
2020



  June 30,
2020



  September 30,
2019



    (Unaudited)


  (Unaudited)


  (Unaudited)


                         
Net Income (Loss) Before Noncontrolling Interest (GAAP)   $ 10,753,009     $ (11,763,937 )   $ (14,337,936 )
Interest Income, net     (5,397 )     (16,410 )     (407,509 )
Interest Expense, net     4,460,125       4,734,908       5,912,290  
Income Taxes     28,436,332       15,378,715       3,624,333  
Other (Income) Expense, net     (6,432,883 )     5,717,427       6,585,540  
Depreciation and Amortization     11,534,876       14,239,915       7,685,428  
                         
Earnings Before Interest, Taxes, Depreciation and Amortization          
(EBITDA) (non-GAAP measure)   $ 48,746,062     $ 28,290,618     $ 9,062,146  
             
Share-based Compensation, Non-Cash     4,435,634       5,700,144       3,564,095  
Acquisition, Transaction, and Other Non-Operating Costs         1,421,949       1,160,150  
             
Adjusted Operating EBITDA (non-GAAP measure) $ 53,181,696     $ 35,412,711     $ 13,786,391