Amicus Therapeutics Announces First Quarter 2023 Financial Results and Corporate Updates


1Q23 Revenue Growth of 14% at CER to $86.3M


On Track to Deliver Full-Year 2023 Galafold Revenue Growth of 12%-17% at CER


U.S. FDA Pre-approval Inspection for AT-GAA Complete; Approval Expected 3Q 2023


European Launch of Pombiliti



®



+Opfolda



®



Expected 3Q 2023


Non-GAAP Profitability Projected in 2H 2023


Conference Call and Webcast Today at 8:30 a.m. ET

PHILADELPHIA, May 10, 2023 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the first quarter ended March 31, 2023.

Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc., stated, “We had an outstanding start to 2023 across our global business. In Q1, Galafold saw strong operational growth primarily driven by robust patient demand in our major markets. We are pleased with the outcome of the U.S. FDA inspection of the WuXi Biologics manufacturing facility and remain highly confident in the anticipated global approvals of AT-GAA as we move towards launch in the three largest Pompe markets this year. Our strategic focus remains on continuing to grow Galafold, securing regulatory approvals and launching of AT-GAA, and achieving non-GAAP profitability in the second half of 2023. Together, we see these driving value for our stakeholders and advancing our mission of delivering high quality medicines for people living with rare diseases.”

Corporate Highlights:

  • Global revenue in the first quarter 2023 was $86.3 million. First quarter revenue represented a year-over-year increase of 10% from total revenue of $78.7 million in the first quarter of 2022. First quarter operational revenue growth measured at constant exchange rates (CER)1 was 14%.
(in thousands) Three Months Ended
March 31,
  Year over Year

% Growth
 
  2023   2022   As
Reported
  at CER

1
 
Net Product Revenues $86,270   $78,715   10%   14%  
  • For the full-year 2023, the Company anticipates double-digit Galafold revenue growth of 12-17% at CER

    1

    . Growth is expected to be driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, label extensions, continued diagnosis of new Fabry patients, and commercial execution across all major markets, including the U.S., EU, U.K., and Japan.
  • The U.S. Food and Drug Administration (FDA) has very recently completed the required pre-approval inspection of the WuXi Biologics manufacturing site in China. The Company believes the comments and observations received at the close of the FDA inspection are all addressable and continues to expect regulatory approval of AT-GAA in the U.S. in the third quarter of 2023.
  • The EU and U.K. AT-GAA regulatory reviews remain on-track with marketing authorization expected in 3Q 2023. In the European Union (EU), the European Commission (EC) granted approval for Pombiliti® (cipaglucosidase alfa), used in combination with miglustat for adults with late-onset Pompe disease. In April, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Opfolda® (miglustat), the enzyme stabilizer component. Full approval of Pombiliti + Opfolda is anticipated in the third quarter of 2023. In the U.K., the regulatory submission process was initiated in December 2022, with final approval expected in the third quarter of 2023.
  • Strategic expansion of Supply and Manufacturing Services Agreement with WuXi Biologics. The long-term agreement further strengthens relationship with WuXi and secures long-term capacity at the new state-of-the-art manufacturing facility of WuXi in Dundalk, Ireland.
  • Expanded access programs continue to meet the growing demand for AT-GAA across multiple countries. In the U.K., under the Early Access to Medicines Scheme (EAMS), multiple physicians have requested access from each of the leading Pompe centers in the country. Many patients with Pompe disease are participating in additional expanded access programs in the U.S., Germany, France, and Japan.
  • Galafold U.S. intellectual property estate strengthened following the issuance of multiple new patents in 2023. Galafold is protected by orphan drug regulatory exclusivities and a broad U.S. intellectual property portfolio of 49 orange book-listed patents, including 8 composition of matter patents, 33 of which provide protection through at least 2038.
  • Full-year 2023 non-GAAP operating expense guidance of $340 million to $360 million, driven by prudent expense management while investing in AT-GAA manufacturing and pre-launch activities.
  • Based on the current operating plan, the timing of AT-GAA approvals, and through prudent management of expenses, the Company is on-track to achieve non-GAAP profitability

    2

    in the second half of 2023.


First Quarter 2023 Financial Results

  • Total revenue in the first quarter 2023 was $86.3 million, a year-over-year increase of 10% from total revenue of $78.7 million in the first quarter 2022. On a constant currency basis, first quarter 2023 total revenue growth was 14%. Compared to the first quarter 2022, reported revenue was offset by a negative currency impact of $3.8 million, or 4%.
  • Cash, cash equivalents, and marketable securities totaled $267.1 million at March 31, 2023, compared to $293.6 million at December 31, 2022.
  • Total GAAP operating expenses of $117.0 million for the first quarter 2023 decreased as compared to $146.5 million for the first quarter 2022.
  • Total non-GAAP operating expenses of $80.6 million for the first quarter 2023 decreased as compared to $109.0 million for the first quarter 2022, primarily reflecting decreased program spend.3
  • Net loss was $52.9 million, or $0.18 per share in the first quarter 2023, and was reduced compared to a net loss of $85.3 million, or $0.30 per share, for the first quarter 2022.


2023 Financial Guidance

  • For the full-year 2023, the Company anticipates total Galafold revenue growth between 12 and 17% at CER1 driven by continued underlying demand from both switch and treatment-naïve patients, geographic expansion, label extensions, the continued diagnosis of new Fabry patients, and commercial execution across all major markets, including the U.S., EU, U.K., and Japan.
  • Non-GAAP operating expense guidance for the full-year 2023 is $340 million to $360 million, driven by prudent expense management offset by continued investment in Galafold, AT-GAA clinical studies and pre-launch activities, in addition to certain non-recurring costs for manufacturing to support the global launch of AT-GAA4.
  • The Company is on-track to achieve non-GAAP profitability2 in the second half of 2023.


Amicus is focused on the following five key strategic priorities in 2023:

  • Sustain double-digit Galafold revenue growth (12-17% at CER1)
  • Secure FDA, EMA, and MHRA approvals for AT-GAA
  • Initiate successful global launches of AT-GAA
  • Advance next generation pipeline programs (Fabry GTx, Fabry Next-Generation Chaperone, Pompe GTx)
  • Maintain strong financial position on path to profitability

1 In order to illustrate underlying performance, Amicus discusses its results in terms of constant exchange rate (CER) growth. This represents growth calculated as if the exchange rates had remained unchanged from those used in the comparative period. Full-year 2023 Galafold revenue guidance utilizes the actual exchange rates at December 31, 2022.
2 Based on projections of Amicus’ non-GAAP Net Income under current operating plans, which includes successful AT-GAA regulatory approvals and continued Galafold growth. Amicus defines non-GAAP Net Income as GAAP Net Income excluding the impact of share-based compensation expense, changes in fair value of contingent consideration, loss on impairment of assets, depreciation and amortization, acquisition related income (expense), loss on extinguishment of debt, restructuring charges and income taxes.
3 Full reconciliation of GAAP results to the Company’s non-GAAP adjusted measures for all reporting periods appear in the tables to this press release.
4 A reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure is not available without unreasonable effort due to high variability, complexity, and low visibility as to the items that would be excluded from the GAAP measure.



Conference Call and Webcast

Amicus Therapeutics will host a conference call and audio webcast today, May 10, 2023, at 8:30 a.m. ET to discuss the first quarter 2023 financial results and corporate updates. Participants and investors interested in accessing the call by phone will need to register using the online registration form. After registering, all phone participants will receive a dial-in number along with a personal PIN number to access the event.

A live audio webcast and related presentation materials can also be accessed via the Investors section of the Amicus Therapeutics corporate website at ir.amicusrx.com. Web participants are encouraged to register on the website 15 minutes prior to the start of the call. An archived webcast and accompanying slides will be available on the Company’s website shortly after the conclusion of the live event.


About Galafold

 

Galafold® (migalastat) 123 mg capsules is an oral pharmacological chaperone of alpha-Galactosidase A (alpha-Gal A) for the treatment of Fabry disease in adults who have amenable galactosidase alpha gene (GLA) variants. In these patients, Galafold works by stabilizing the body’s own dysfunctional enzyme so that it can clear the accumulation of disease substrate. Globally, Amicus Therapeutics estimates that approximately 35 to 50 percent of Fabry patients may have amenable GLA variants, though amenability rates within this range vary by geography. Galafold is approved in more than 40 countries around the world, including the U.S., EU, U.K., and Japan.

U.S. INDICATIONS AND USAGE

Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

U.S. IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

The most common adverse reactions reported with Galafold (≥10%) were headache, nasopharyngitis, urinary tract infection, nausea and pyrexia.

USE IN SPECIFIC POPULATIONS

There is insufficient clinical data on Galafold use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.

It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition.

Galafold is not recommended for use in patients with severe renal impairment or end-stage renal disease requiring dialysis.

The safety and effectiveness of Galafold have not been established in pediatric patients.

To report Suspected Adverse Reactions, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional information about Galafold, including the full U.S. Prescribing Information, please visit https://www.amicusrx.com/pi/Galafold.pdf.


EU Important Safety Information


Treatment with Galafold should be initiated and supervised by specialists experienced in the diagnosis and treatment of Fabry disease. Galafold is not recommended for use in patients with a nonamenable mutation.

  • Galafold is not intended for concomitant use with enzyme replacement therapy.
  • Galafold is not recommended for use in patients with Fabry disease who have severe renal impairment (<30 mL/min/1.73 m2). The safety and efficacy of Galafold in children less than 12 years of age have not yet been established. No data are available.
  • No dosage adjustments are required in patients with hepatic impairment or in the elderly population.
  • There is very limited experience with the use of this medicine in pregnant women. If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take this medicine until you have checked with your doctor, pharmacist, or nurse.
  • While taking Galafold, effective birth control should be used. It is not known whether Galafold is excreted in human milk.
  • Contraindications to Galafold include hypersensitivity to the active substance or to any of the excipients listed in the PRESCRIBING INFORMATION.
  • Galafold 123 mg capsules are not for children (≥12 years) weighing less than 45 kg.
  • It is advised to periodically monitor renal function, echocardiographic parameters and biochemical markers (every 6 months) in patients initiated on Galafold or switched to Galafold.
  • OVERDOSE: General medical care is recommended in the case of Galafold overdose.
  • The most common adverse reaction reported was headache, which was experienced by approximately 10% of patients who received Galafold. For a complete list of adverse reactions, please review the SUMMARY OF PRODUCT CHARACTERISTICS.
  • Call your doctor for medical advice about side effects.

For further important safety information for Galafold, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Galafold available from the EMA website at www.ema.europa.eu.


About Fabry Disease

Fabry disease is an inherited lysosomal disorder caused by deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), which results from mutations in the GLA gene. The primary biological function of alpha-Gal A is to degrade specific lipids in lysosomes, including globotriaosylceramide (referred to here as GL-3 and also known as Gb3). Lipids that can be degraded by the action of alpha-Gal A are called “substrates” of the enzyme. Reduced or absent levels of alpha-Gal A activity lead to the accumulation of GL-3 in the affected tissues, including heart, kidneys, and skin. Accumulation of GL-3 and progressive deterioration of organ function is believed to lead to the morbidity and mortality of Fabry disease. The symptoms can be severe, differ from person to person, and begin at an early age.


About Pompe Disease


Pompe disease is an inherited lysosomal disorder caused by deficiency of the enzyme acid alpha-glucosidase (GAA). Reduced or absent levels of GAA lead to accumulation of glycogen in cells, which is believed to result in the clinical manifestations of Pompe disease. Pompe disease ranges from a rapidly fatal infantile form with significant impacts to heart function, to a more slowly progressive, late-onset form primarily affecting skeletal muscle and progressive respiratory involvement. Late-onset Pompe disease can be severe and debilitating, including progressive muscle weakness throughout the body, particularly the skeletal muscles and muscles controlling breathing, that worsens over time.


About Amicus Therapeutics


Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. For more information please visit the company’s website at www.amicusrx.com, and follow on Twitter and LinkedIn.


Non-GAAP Financial Measures


In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. When we provide our expectation for non-GAAP operating expenses on a forward-looking basis, a reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure generally is not available without unreasonable effort due to potentially high variability, complexity and low visibility as to the items that would be excluded from the GAAP measure in the relevant future period, such as unusual gains or losses. The variability of the excluded items may have a significant, and potentially unpredictable, impact on our future GAAP results.


Forward Looking Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinical trials, the prospects and timing of the potential regulatory approval of our product candidates, commercialization plans, manufacturing and supply plans, financing plans, and the projected revenues and cash position for the Company. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities, including as they are impacted by COVID-19 related disruption, are based on current information. The potential impact on operations from the COVID-19 pandemic is inherently unknown and cannot be predicted with confidence and may cause actual results and performance to differ materially from the statements in this release, including without limitation, because of the impact on general political and economic conditions, including as a result of efforts by governmental authorities to mitigate COVID-19, such as travel bans, shelter in place orders and third-party business closures and resource allocations, manufacturing and supply chain disruptions and limitations on patient access to commercial or clinical product. In addition to the impact of the COVID-19 pandemic, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: the potential that results of clinical or preclinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities, including the FDA, EMA, MHRA, and PMDA, may not grant or may delay approval for our product candidates; the potential that required regulatory inspections may be delayed or not be successful and delay or prevent product approval; the potential that we may not be successful in commercializing Galafold in Europe, Japan, the US and other geographies or AT-GAA if and when approved; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; the potential that we may not be able to manufacture or supply sufficient clinical or commercial products; and the potential that we will need additional funding to complete all of our studies and manufacturing. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results. Statements regarding corporate financial guidance and financial goals and the attainment of such goals. With respect to statements regarding projections of the Company’s revenue and cash position, actual results may differ based on market factors and the Company’s ability to execute its operational and budget plans. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2022, and on Form 10-Q for the quarter ended March 31, 2023, to be filed today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

CONTACT:

Investors:

Amicus Therapeutics
Andrew Faughnan

Vice President, Investor Relations
[email protected]
(609) 662-3809

Media:

Amicus Therapeutics
Diana Moore
Head of Global Corporate Communications

[email protected]

(609) 662-5079

FOLD-G

TABLE 1

Amicus Therapeutics, Inc.

Consolidated Statements of Operations

(Unaudited)

(in thousands, except share and per share amounts) 
  Three Months Ended March 31,
    2023       2022  
Net product sales $ 86,270     $ 78,715  
Cost of goods sold   6,942       7,582  
Gross profit   79,328       71,133  
Operating expenses:      
Research and development   41,499       81,517  
Selling, general, and administrative   73,957       58,116  
Changes in fair value of contingent consideration payable   251          (1,188 )
Loss on impairment of assets         6,616  
Depreciation and amortization   1,257       1,411  
Total operating expenses   116,964       146,472  
Loss from operations   (37,636 )     (75,339 )
Other (expense) income:      
Interest income   2,199       133  
Interest expense   (11,844 )     (8,147 )
Other (expense) income   (5,938 )     1,902  
Loss before income tax   (53,219 )     (81,451 )
Income tax benefit (expense)   287       (3,809 )
Net loss attributable to common stockholders $ (52,932 )   $ (85,260 )
Net loss attributable to common stockholders per common share — basic and diluted $ (0.18 )   $ (0.30 )
Weighted-average common shares outstanding — basic and diluted   291,336,750       288,481,741  

TABLE 2

Amicus Therapeutics, Inc.

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share amounts)   
  March 31,

2023
  December 31,
2022
Assets      
Current assets:      
Cash and cash equivalents $ 160,602     $ 148,813  
Investments in marketable securities   106,507       144,782  
Accounts receivable   68,178       66,196  
Inventories   27,004       23,816  
Prepaid expenses and other current assets   37,406       40,209  
Total current assets   399,697       423,816  
Operating lease right-of-use assets, net   28,483       29,534  
Property and equipment, less accumulated depreciation of $22,901 and $22,281 at March 31, 2023 and December 31, 2022, respectively   31,406       30,778  
Intangible asset, less accumulated depreciation of $36 and $0 at March 31, 2023 and December 31, 2022, respectively   22,964       23,000  
Goodwill   197,797       197,797  
Other non-current assets   20,172       19,242  
Total Assets $ 700,519     $ 724,167  
Liabilities and Stockholders’ Equity      
Current liabilities:      
Accounts payable $ 24,965     $ 15,413  
Accrued expenses and other current liabilities   92,747       93,636  
Contingent consideration payable   12,668       21,417  
Operating lease liabilities   8,005       8,552  
Total current liabilities   138,385       139,018  
Long-term debt   392,658       391,990  
Operating lease liabilities   51,349       51,578  
Deferred reimbursements   5,906       4,656  
Deferred income taxes         4,939  
Other non-current liabilities   9,648       8,939  
Total liabilities   597,946          
Commitments and contingencies      
Stockholders’ equity:      
Common stock, $0.01 par value, 500,000,000 shares authorized, 283,300,585 and 281,108,273 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively   2,820       2,815  
Additional paid-in capital   2,691,836       2,664,744  
Accumulated other comprehensive loss:      
Foreign currency translation adjustment   (6,543 )     (11,989 )
Unrealized loss on available-for-sale securities   (201 )     (116 )
Warrants   83       83  
Accumulated deficit   (2,585,422 )     (2,532,490 )
Total stockholders’ equity   102,573       123,047  
Total Liabilities and Stockholders’ Equity $            700,519     $ 724,167   

TABLE 3

Amicus Therapeutics, Inc.

Reconciliation of Non-GAAP Financial Measures

(in thousands) 
  Three Months Ended March 31,
    2023     2022  
Total operating expenses – as reported GAAP $ 116,964   $ 146,472  
Research and development:      
Stock-based compensation   8,490     9,365  
Selling, general and administrative:      
Stock-based compensation   26,404     21,286  
Loss on impairment of assets       6,616  
Changes in fair value of contingent consideration payable   251     (1,188 )
Depreciation and amortization   1,257     1,411  
Total operating expense adjustments to reported GAAP   36,402     37,490  
Total operating expenses – as adjusted $ 80,562   $ 108,982  



Benson Hill Announces First Quarter 2023 Financial Results

Benson Hill Announces First Quarter 2023 Financial Results

  • Reported revenues increased 104 percent year-over-year to approximately $135 million, including an increase of 80 percent in proprietary revenues.
  • Reported gross profit was $9.5 million ($4.3 million when excluding an approximate $5.2 million impact from open mark-to-market timing differences).
  • The Company improved its 2023 guidance for Adjusted EBITDA and free cash flow.

ST. LOUIS–(BUSINESS WIRE)–Benson Hill, Inc. (NYSE: BHIL, the “Company” or “Benson Hill”), a food tech company unlocking the natural genetic diversity of plants, today announced operating and financial results for the quarter ended March 31, 2023.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230510005306/en/

Benson Hill Announces First Quarter 2023 Financial Results (Graphic: Business Wire)

Benson Hill Announces First Quarter 2023 Financial Results (Graphic: Business Wire)

“Our first quarter results represent a continuation of the momentum created in 2022,” said Matt Crisp, Chief Executive Officer of Benson Hill. “We are confident this year can represent an inflection point for proprietary revenue growth and margin expansion as we lean into the capabilities of our closed-loop model and realize a greater anticipated contribution from partnership and licensing agreements.”

First Quarter Results Compared to the Same Period of 2022

The following financial results exclude the pending divestiture of the Fresh business announced on January 3, 2023, which is now recorded as discontinued operations. The impact of open mark-to-market timing differences on the profit and loss statement and reconciliation of non-GAAP financial measures can be found in the accompanying financial tables.

  • Revenues were $134.6 million, an increase of $68.5 million, or 103.6 percent. Strong demand from customers and greater availability of proprietary soy ingredients, meal and edible oil products resulted in an 80 percent increase in proprietary revenues to $25.3 million. Non-proprietary revenues increased more than 100 percent from a continuation of favorable soy and yellow pea commodity prices and strong operational execution. Reported revenues include a favorable $6.7 million impact from open mark-to-market timing differences.

  • Gross profit was $9.5 million, an increase of $18.5 million. Excluding an approximate $5.2 million favorable impact from open mark-to-market timing differences, gross profit was $4.3 million and gross margins were approximately 3.4 percent. Favorable top line growth, proprietary revenue mix, and contributions from partnership and licensing agreements were partially offset by ongoing inflationary and supply chain pressures.

  • Operating expenses were $28.8 million, a decrease of $3.7 million. The majority of the improvement was from actions associated with the Company’s Liquidity Improvement Plan. Approximately $6.1 million of operating expense in the quarter related to non-cash items primarily stock compensation and depreciation.

    • Selling, general and administrative expenses were $16.2 million, a decrease of $4.1 million or 20.2 percent.

    • R&D expenses were $12.6 million, an increase of $0.3 million or 2.8 percent.

  • Inclusive of open mark-to-market timing differences, net loss from continuing operations was $4.8 million, a decrease in loss of $12.6 million or 72.2 percent. Adjusted EBITDA was a loss of $10.7 million, or an approximate loss of $16.0 million when excluding the impact from open mark-to-market timing differences.

  • Cash, restricted cash, and marketable securities of $131.0 million were on hand as of March 31, 2023.

2023 Outlook

Excludes the Fresh business which is classified as discontinued operations.

Management reaffirmed its guidance for proprietary revenues in the range of $100 million to $110 million, a 40 percent to 50 percent increase over the prior year. Consistent with prior guidance, non-proprietary revenues are expected to decline moderately in favor of proprietary products, which sets the expectation for consolidated revenues to be in the range of $390 million to $430 million.

Consistent with prior guidance, consolidated gross profit is expected to be in the range of $20 million to $30 million driven by anticipated increases in proprietary sales, greater anticipated contribution from partnership and licensing agreements, and favorable soy commodity markets for non-proprietary product sales. This outlook includes assumptions for a continuation of inflationary pressures and challenges in supply chain logistics.

The Company has taken actions to realize an annual run rate cash savings of more than $10 million from its Liquidity Improvement Plan, which is now expected to lower full year operating expenses to a range of $115 million to $120 million. As a result, management has improved its expected net loss from continuing operations to a range of $115 million to $125 million, Adjusted EBITDA loss to a range of $53 million to $58 million, and free cash flow outflow to a range of $110 million to $118 million.

Webcast

A webcast of the earnings conference call will begin at 8:30 a.m. EDT today. The link to participate is available on the Investor Relations page of the Company’s website.

About Benson Hill

Benson Hill moves food forward with the CropOS® platform, a cutting-edge food innovation engine that combines data science and machine learning with biology and genetics. Benson Hill empowers innovators to unlock nature’s genetic diversity from plant to plate, with the purpose of creating nutritious, great-tasting food and ingredient options that are both widely accessible and sustainable. More information can be found at bensonhill.com or on Twitter at @bensonhillinc.

Use of Non-GAAP Financial Measures

In this press release, the Company includes references to non-GAAP performance measures. The Company uses these non-GAAP financial measures to facilitate management’s financial and operational decision-making, including evaluation of the Company’s historical operating results. The Company’s management believes these non-GAAP measures are useful in evaluating the Company’s operating performance and are similar measures reported by publicly listed U.S. competitors, and regularly used by securities analysts, institutional investors, and other interested parties in analyzing operating performance and prospects. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results and the reconciliations to corresponding GAAP financial measures, may provide a more complete understanding of factors and trends affecting the Company’s business. By referencing these non-GAAP measures, the Company’s management intends to provide investors with a meaningful, consistent comparison of the Company’s performance for the periods presented. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. The Company’s definition of these non-GAAP measures may differ from similarly titled measures of performance used by other companies in other industries or within the same industry. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the Company’s condensed consolidated financial statements and publicly filed reports in their entirety.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the tables accompanying this press release.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release may be considered “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance and may be identified by words such as “may,” “should,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” or similar words. These forward-looking statements are based upon assumptions made by the Company as of the date hereof and are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements include, among other things, statements regarding the Company’s current guidance regarding certain expected 2023 financial and operating results, including guidance regarding consolidated, proprietary and non-proprietary revenues, anticipated contribution from partnership and licensing agreements, margins, consolidated gross profit, net loss from continuing operations, Adjusted EBITDA, run rate cash savings, operating expenses, and free cash flow; statements regarding the Company’s current expectations and assumptions regarding the industries and markets in which it operates, and macro-economic trends, including regarding commodity markets and inflationary pressures; projections of market opportunity and supply chain constraints; statements regarding the Company’s Liquidity Improvement Plan, actions to implement such plan, and the anticipated benefits of such plan; expectations regarding revenue and gross profit mix; expectations regarding future costs and uses of free cash flow; expectations regarding the unwinding of mark-to-market timing differences and the Company’s assessment of its futures contracts; any financial or other information based upon or otherwise incorporating judgments or estimates relating to future performance, events or expectations; expectations regarding the Company’s hedging and other risk management strategies, including expectations about future sales and purchases that relate to the Company’s mark-to-market adjustments and the fair valuation of futures contracts; the Company’s strategies, positioning, resources, capabilities, and expectations for future performance; estimates and forecasts of financial and other performance metrics; the Company’s outlook and financial and other guidance. Factors that may cause actual results to differ materially from current expectations and guidance include, but are not limited to: risks associated with the Company’s Liquidity Improvement Plan, including potentially adverse impacts on the Company’s business and prospects even if such plan is successful; the risk that the Company’s actions relating to its Liquidity Improvement Plan may be insufficient to achieve the objectives of such plan; risks associated with the Company’s ability to grow and achieve growth profitably, including continued access to the capital resources necessary for growth; the risk that the Company will be unable to renegotiate or retire any of its existing debt by entering into an amended or new facility in a timely manner, on favorable terms, or at all; risks relating to the failure to realize the anticipated benefits of the Company’s shelf registration statement, including its at-the-market facility, or otherwise fail to raise equity or other capital to supplement its cash needs; risks relating to the Company’s hedging and other risk management strategies, including expectations about future sales and purchases that relate to the Company’s mark-to-market adjustments and the fair valuation of futures contracts; the risk that the Company will not realize the anticipated benefits of the divestiture of the Fresh business, including risks relating to the failure to satisfy the conditions to the consummation of the pending transaction to sell the remaining assets of the Fresh business, and the risk that such transaction may not be completed in a timely manner or at all; risks associated with managing capital resources; risks associated with maintaining relationships with customers and suppliers and developing and maintaining partnering and licensing relationships; risks associated with changing industry conditions and consumer preferences; risks associated with the Company’s ability to generally execute on its business strategy; risks associated with the effects of global and regional economic, agricultural, financial and commodities market, political, social and health conditions; risks associated with the Company’s transition to becoming a public company; the effectiveness of the Company’s risk management strategies; and other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in our filings with the SEC, which are available on the SEC’s website at www.sec.gov. Forward-looking statements are also subject to the risks and other issues described above under “Use of Non-GAAP Financial Measures,” which could cause actual results to differ materially from current expectations included in the Company’s forward-looking statements included in this press release. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved, including without limitation, any expectations about our operational and financial performance or achievements. There may be additional risks about which the Company is presently unaware or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. The reader should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any duty to update these forward-looking statements, except as otherwise required by law.

Benson Hill, Inc.

Material Items Included in Consolidated Revenues and Cost of Sales

(USD In Thousands)

Currently, the Company does not seek cash flow hedge accounting treatment for its derivative financial instruments and thus changes in fair value are reflected in current earnings.

Mark-to-market timing difference comprises the estimated net temporary impact resulting from unrealized period-end gains/losses associated with the fair valuation of futures contracts associated with the Company’s committed future operating capacity. These mark-to-market timing differences are not indicative of the Company’s operating performance.

The Company recorded the fair value of acquired sales and purchase contracts in the acquisition of the Company’s Creston, Iowa location, which are amortized, not marked-to-market, to revenues and cost of sales to the physical contracts.

The table below summarizes the pre-tax gains and losses related to derivatives and contract assets and liabilities:

 

Three Months Ended March 31, 2023

 

 

 

Open Mark-to-Market Timing Differences

Reported

 

Impact

 

Excluding

Revenues

$

134,643

 

 

$

6,725

 

$

127,918

 

Gross profit

$

9,523

 

 

$

5,229

 

$

4,294

 

Total operating expenses

$

28,809

 

 

$

 

$

28,809

 

Net loss from continuing operations

$

(4,845

)

 

$

5,229

 

$

(10,074

)

Adjusted EBITDA

$

(10,733

)

 

$

5,229

 

$

(15,962

)

  • See Adjusted EBITDA reconciliation in the accompanying financial tables.

 

 

Benson Hill, Inc.

Condensed Consolidated Balance Sheets (Unaudited)

(USD In Thousands)

 

March 31,

2023

 

December 31,

2022

Assets

Current assets:

Cash and cash equivalents

$

20,399

 

 

$

25,053

 

Marketable securities

 

89,873

 

 

 

132,121

 

Accounts receivable, net

 

28,986

 

 

 

28,591

 

Inventories, net

 

54,549

 

 

 

62,110

 

Prepaid expenses and other current assets

 

30,490

 

 

 

29,346

 

Current assets held for sale

 

22,832

 

 

 

23,507

 

Total current assets

 

247,129

 

 

 

300,728

 

Property and equipment, net

 

99,366

 

 

 

99,759

 

Finance lease right-of-use assets, net

 

64,860

 

 

 

66,533

 

Operating lease right-of-use assets

 

5,008

 

 

 

1,660

 

Goodwill and intangible assets, net

 

27,189

 

 

 

27,377

 

Other assets

 

5,362

 

 

 

4,863

 

Total assets

$

448,914

 

 

$

500,920

 

 

 

 

 

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

19,794

 

 

$

36,717

 

Current finance lease liabilities

 

3,514

 

 

 

3,318

 

Current operating lease liabilities

 

679

 

 

 

364

 

Current maturities of long-term debt

 

2,244

 

 

 

2,242

 

Accrued expenses and other current liabilities

 

19,010

 

 

 

33,435

 

Current liabilities held for sale

 

13,975

 

 

 

16,441

 

Total current liabilities

 

59,216

 

 

 

92,517

 

Long-term debt

 

103,447

 

 

 

103,991

 

Long-term finance lease liabilities

 

76,087

 

 

 

76,431

 

Long-term operating lease liabilities

 

4,292

 

 

 

1,291

 

Warrant liability

 

9,107

 

 

 

24,285

 

Conversion option liability

 

1,572

 

 

 

8,091

 

Deferred tax liabilities

 

295

 

 

 

283

 

Other non-current liabilities

 

259

 

 

 

129

 

Total liabilities

 

254,275

 

 

 

307,018

 

Stockholders’ equity:

 

Common stock, $0.0001 par value, 440,000 and 440,000 shares authorized, 207,459 and 206,668 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively

 

21

 

 

 

21

 

Additional paid-in capital

 

612,385

 

 

 

609,450

 

Accumulated deficit

 

(411,528

)

 

 

(408,474

)

Accumulated other comprehensive loss

 

(6,239

)

 

 

(7,095

)

Total stockholders’ equity

 

194,639

 

 

 

193,902

 

Total liabilities and stockholders’ equity

$

448,914

 

 

$

500,920

 

 

 

Benson Hill, Inc.

Condensed Consolidated Statements of Operations (Unaudited)

(USD In Thousands, Except Per Share Information)

 

Three Months Ended March 31,

 

2023

 

 

 

2022

 

Revenues

$

134,643

 

 

$

66,126

 

Cost of sales

 

125,120

 

 

 

75,061

 

Gross profit (loss)

 

9,523

 

 

 

(8,935

)

Operating expenses:

 

Research and development

 

12,642

 

 

 

12,295

 

Selling, general and administrative expenses

 

16,167

 

 

 

20,255

 

Total operating expenses

 

28,809

 

 

 

32,550

 

Loss from operations

 

(19,286

)

 

 

(41,485

)

Other (income) expense:

 

Interest expense, net

 

6,372

 

 

 

6,388

 

Loss on extinguishment of debt

 

 

 

Change in fair value of warrants and conversion options

 

(21,696

)

 

 

(31,741

)

Other (income) expense, net

 

868

 

 

 

1,331

 

Total other (income) expense, net

 

(14,456

)

 

 

(24,022

)

Net loss from continuing operations before income tax

 

(4,830

)

 

 

(17,463

)

Income tax expense (benefit)

 

15

 

 

 

(39

)

Net loss from continuing operations, net of tax

 

(4,845

)

 

 

(17,424

)

Net (loss) income from discontinued operations, net of tax

 

1,791

 

 

 

848

 

Net loss

$

(3,054

)

 

$

(16,576

)

 

 

 

 

Net loss per common share:

 

 

 

Basic and diluted net loss per common share from continuing operations

$

(0.03

)

 

$

(0.11

)

Basic and diluted net income per common share from discontinued operations

$

0.01

 

 

$

0.01

 

Basic and diluted net loss per common share

$

(0.02

)

 

$

(0.10

)

Weighted average shares outstanding:

 

Basic and diluted weighted average shares outstanding

 

187,113

 

 

 

160,711

 

 

Benson Hill, Inc.

Condensed Consolidated Statements of Comprehensive Loss (Unaudited)

(USD In Thousands)

 

Three Months Ended March 31,

 

2023

 

 

 

2022

 

Net loss

$

(3,054

)

 

$

(16,576

)

Foreign currency:

 

Comprehensive loss

 

 

 

 

(65

)

 

 

 

 

 

(65

)

Marketable securities:

 

 

 

Comprehensive income (loss)

 

1,906

 

 

 

(3,766

)

Adjustment for net income (losses) realized in net loss

 

(1,050

)

 

 

1,207

 

 

 

856

 

 

 

(2,559

)

Total other comprehensive income (loss)

 

856

 

 

 

(2,624

)

Total comprehensive loss

$

(2,198

)

 

$

(19,200

)

 

 

 

 

 

   

Benson Hill, Inc.

Condensed Consolidated Statements of Cash Flows (Unaudited)

(USD In Thousands)

   

 

Three Months Ended March 31,

 

 

2023

 

 

 

2022

 

Operating activities

 

 

 

 

Net loss

 

$

(3,054

)

 

$

(16,576

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

Depreciation and amortization

 

 

5,263

 

 

 

5,404

 

Stock-based compensation expense

 

 

2,814

 

 

 

5,683

 

Bad debt expense

 

 

(228

)

 

 

156

 

Change in fair value of warrants and conversion option

 

 

(21,696

)

 

 

(31,741

)

Accretion and amortization related to financing activities

 

 

2,018

 

 

 

2,907

 

Other

 

 

1,700

 

 

 

4,026

 

Changes in operating assets and liabilities:

 

 

 

 

Accounts receivable

 

 

(1,188

)

 

 

(3,245

)

Inventories

 

 

11,663

 

 

 

(5,054

)

Other assets and other liabilities

 

 

(1,289

)

 

 

(540

)

Accounts payable

 

 

(18,471

)

 

 

(7,540

)

Accrued expenses

 

 

(15,225

)

 

 

(6,672

)

Net cash used in operating activities

 

 

(37,693

)

 

 

(53,192

)

Investing activities

 

 

 

 

Purchases of marketable securities

 

 

(23,277

)

 

 

(84,991

)

Proceeds from maturities of marketable securities

 

 

25,997

 

 

 

4,575

 

Proceeds from sales of marketable securities

 

 

38,927

 

 

 

73,196

 

Payments for acquisitions of property and equipment

 

 

(2,680

)

 

 

(3,360

)

Payments made in connection with business acquisitions

 

 

 

 

 

(1,034

)

Other

 

 

27

 

 

 

 

Net cash provided/(used) by/in investing activities

 

 

38,994

 

 

 

(11,614

)

Financing activities

 

 

 

 

Contributions from PIPE Investment, net of transaction costs $18 in 2022

 

 

 

 

 

84,967

 

Principal payments on debt

 

 

(843

)

 

 

(1,316

)

Proceeds from issuance of debt, net of issuance costs

 

 

(2,000

)

 

 

4,078

 

Borrowing under revolving line of credit

 

 

 

 

 

5,726

 

Repayments under revolving line of credit

 

 

 

 

 

(3,916

)

Repayments of financing lease obligations

 

 

(794

)

 

 

(290

)

Proceeds from the exercise of stock awards and withholding taxes for the net share settlement

 

 

122

 

 

 

636

 

Net cash (used)/provided in/by financing activities

 

 

(3,515

)

 

 

89,885

 

Effect of exchange rate changes on cash

 

 

 

 

 

(65

)

Net (decrease) increase in cash and cash equivalents

 

 

(2,214

)

 

 

25,014

 

Cash, cash equivalents and restricted cash, beginning of period

 

 

43,321

 

 

 

78,963

 

Cash, cash equivalents and restricted cash, end of period

 

$

41,107

 

 

$

103,977

 

Supplemental disclosure of cash flow information

 

 

 

 

 

 

Cash paid for interest

 

$

4,698

 

 

 

$

2,473

Supplemental disclosure of non-cash activities

 

 

 

 

 

 

PIPE Investment issuance costs included in accrued expenses and other current

 

$

 

 

 

$

4,143

Purchases of property and equipment included in accounts payable and accrued expenses and other current liabilities

 

$

326

 

 

 

$

3,104

Benson Hill, Inc.

Non-GAAP Reconciliation

(USD In Thousands)

This press release contains financial measures not derived in accordance with generally accepted accounting principles (“GAAP”). Reconciliations to the most comparable GAAP measures are provided below. The Company defines Adjusted EBITDA as net loss from continuing operations excluding income taxes, interest, depreciation, amortization, stock-based compensation, change in fair value of warrants and conversion option, and the impact of significant non-recurring items. The Company defines free cash flow as net cash used in (provided by) operating activities minus capital expenditures.

Adjustments to reconcile net loss from our continuing operations to Adjusted EBITDA are as follows:

 

Three Months Ended March 31,

 

 

2023

 

 

 

2022

 

Net loss from continuing operations

$

(4,845

)

 

$

(17,424

)

Interest expense, net

 

6,372

 

 

 

6,388

 

Income tax expense (benefit)

 

15

 

 

 

(39

)

Depreciation and amortization

 

5,263

 

 

 

4,892

 

Stock-based compensation

 

2,814

 

 

 

5,683

 

Change in fair value of warrants and conversion option

 

(21,696

)

 

 

(31,741

)

Other

 

1,344

 

 

 

1,100

 

Total Adjusted EBITDA

$

(10,733

)

 

$

(31,141

)

Adjustments to reconcile estimated 2023 net loss from continuing operations to estimated Adjusted EBITDA are as follows:

 

2023 Estimate*

Net loss from continuing operations

$

(115,000

)

to

$

(125,000

)

Interest expense, net

 

27,000

 

to

 

29,000

 

Depreciation and amortization

 

21,000

 

to

 

23,000

 

Stock-based compensation

 

14,000

 

to

 

15,000

 

Total Adjusted EBITDA

$

(53,000

)

to

 

(58,000

)

Adjustments to reconcile estimated 2023 free cash flow are as follows:

 

2023 Estimate*

Net loss from continuing operations

$

(115,000

)

to

(125,000

)

Depreciation and amortization

 

21,000

 

to

23,000

 

Stock-based compensation

 

14,000

 

to

15,000

 

Changes in working capital

 

(12,000

)

to

(14,000

)

Other

 

2,000

 

to

8,000

 

Net Cash Used in Operating Activities

$

(90,000

)

to

(93,000

)

Payments for acquisition of property and equipment

 

20,000

 

to

25,000

 

Free Cash Flow

$

(110,000

)

to

(118,000

)

* Categories such as income tax expense (benefit) and changes in fair value of warrants and conversion option, and significant non-recurring items may impact the actual full-year non-GAAP reconciliation for both Adjusted EBITDA and Free Cash Flow. These amounts cannot be estimated at this time.

Investors: Ruben Mella: (314) 714-6313 / [email protected]

Media: Christi Dixon: (636) 359-0797 / [email protected]

KEYWORDS: Missouri United States North America

INDUSTRY KEYWORDS: Natural Disasters Agriculture Food Tech Natural Resources Environment Technology Food/Beverage Retail

MEDIA:

Logo
Logo
Photo
Photo
Benson Hill Announces First Quarter 2023 Financial Results (Graphic: Business Wire)

Coya Therapeutics, Inc. Provides Business Update and Reports Q1 2023 Unaudited Financial Results

Coya Therapeutics, Inc. Provides Business Update and Reports Q1 2023 Unaudited Financial Results

HOUSTON–(BUSINESS WIRE)–
Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance the function of Regulatory T Cells (Tregs), today announced its financial results for the first quarter ended March 31, 2023, and provided a clinical and business update.

Q1 2023 and Recent Highlights (Unaudited)

  • Announced positive results from a proof-of-concept, open-label academic clinical study of COYA 302 in Amyotrophic Lateral Sclerosis (ALS) illustrating halting of disease progression at 24 weeks with minimal decline at 48 weeks. Study data were presented at the 2023 Muscle Dystrophy Association Conference;

  • Announced the presentation of results from an academic clinical study in eight patients with mild to moderate Alzheimer’s Disease (AD) with Coya’s COYA 301, its proprietary investigational biologic, evaluating its safety and tolerability, biological activity, blood biomarkers and preliminary efficacy. The presentation will be made at the 2023 Keystone Symposia Neurodegeneration: Biology Guiding the Next Generation of Therapeutic Development, to be held at Whistler, British Columbia, Canada, from May 15-19th, 2023;

  • Appointed Arun Swaminathan, Ph.D. as Chief Business Officer, who negotiated significant licensing transactions with two top-ten global pharmaceutical companies while at Alteogen, Inc.;

  • Entered into a worldwide agreement with Dr. Reddy’s Laboratories Limited. (Dr. Reddy’s)(NYSE: RDY), whereby Coya in-licensed Dr. Reddy’s proposed Abatacept biosimilar, for the development of COYA 302 the Company’s combination product candidate for the treatment of certain neurodegenerative diseases, and out-licensed to Dr. Reddy’s, COYA 301, the Company’s low dose Interleukin 2 (IL-2) product candidate to permit the commercialization by Dr. Reddy’s of COYA 302 in territories not otherwise granted to Coya;

  • Expanded its exclusive worldwide licensing agreement with ARScience Biotherapeutics for the development and commercialization of COYA 301;

  • Reported preclinical data in an animal model of Alzheimer’s disease supporting the role of expanded Regulatory T Cells (Tregs) as a target for development of potential disease modifying treatments for this form of dementia;

  • Closed an Initial Public Offering of common stock and warrants on January 3, 2023 and overallotment option on January 25, 2023, for aggregate gross proceeds of approximately $16.4 million and net proceeds of $14.1 million.

“In Q1, we were pleased to report promising positive clinical data for COYA 302, illustrating that this biologic combination halted disease progression in ALS patients at 24 weeks with minimal decline at 48 weeks,” stated Howard Berman, Ph.D., Chief Executive Officer of Coya. “Subsequent to quarter end, we bolstered our leadership team with the addition of an accomplished Chief Business Officer, Arun Swaminathan, Ph.D. We are excited about the potential for Arun to unlock attractive business development alliances and strategic transactions. We also announced an upcoming presentation in Alzheimer’s Disease (AD) data with COYA 301 at the 2023 Keystone Symposia on Neurodegeneration to be held from May 15 – 19 that we believe may further illustrate the potential benefit of enhancing Tregs in dementia. Looking ahead, we’re excited to deliver more data and execute on milestones to maximize shareholder value,” concluded Dr. Berman.

Anticipated Events and Milestones:

Treg-Enhancing / T Effector and Macrophage Depleting Biologics Combination

COYA 302* for neurodegenerative diseases:

*Proof-of concept clinical data in Amyotrophic Lateral Sclerosis (ALS) has been generated in an investigator-initiated study (IIT) conducted at Houston Methodist Hospital. POC data was presented March 21, 2023.

Dates of Anticipated Milestones:

H2 2023- File IND and initiate well powered and randomized phase 2 trial in ALS patients

H2 2023- Publication of peer-reviewed article on proof of concept IIT POC data

H2 2023- Publication of biomarker data documenting correlative markers associated with Treg therapies in ALS

Treg-Enhancing Biologic

COYA 301

Proof of concept clinical data in eight patients with mild to moderate Alzheimer’s Disease (AD) evaluating its safety and tolerability, biological activity, blood biomarkers and preliminary efficacy has been generated via an investigator-initiated study conducted at Houston Methodist Hospital

May 2023- Results of the proof of concept study in AD will be presented at the Keystone Conference ‘Neurodegeneration: New Biology Guiding the Next Generation of Therapeutic Development’ in Whistler, B.C. Canada

July 2023- Results of the proof of concept study in AD will be presented at the Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands

Antigen-Directed Allogeneic Treg-Derived Exosomes

COYA 206 for undisclosed indications: target and cargo validation (H2 2023).

Financial Results (Unaudited)

As of March 31, 2023, Coya had cash and cash equivalents of $16.3 million.

Research and development (R&D) expenses were $1.2 million for the quarter ended March 31, 2023, compared to $1.0 million for the quarter ended March 31, 2022. The change in research and development expense of approx. $0.2 million was primarily due to increasing Coya’s clinical trial expenses as well as an increase in employee headcount to support the Company’s continued trials. The Company believes that R&D spending in 2023 will increase over 2022 spending levels and will be focused primarily on advancing COYA 301 and 302.

General and administrative expenses were $1.7 million for the quarter ended March 31, 2023, and $0.7 million for the quarter ended March 31, 2022, a change of approximately $1.0 million. The change was primarily due to an increase in personnel related expenses due to increases in employee headcount and an increase in professional fees and consulting fees as the Company expanded its operations. The Company expects general and administrative costs to continue to grow in 2023 as Coya expands its business development activities as well as incurs additional costs associated with being a public company including higher expense for investor and public relations, director and officer insurance, and audit and compliance.

Net loss was $2.7 million for the quarter ended March 31, 2023, compared to net loss of $1.7 million for the quarter ended March 31, 2022. Net loss reflects the changes in operating expenses discussed above as well as $0.2 million of other income for the quarter ended March 31, 2023, principally interest, earned on the Coya’s cash balances.

CONDENSED BALANCE SHEETS 

 

 

March 31,

 

December 31,

 

 

2023

 

2022

 

 

(unaudited)

 

 

Assets

 

 

 

 

Current Assets:

 

 

 

 

Cash and cash equivalents

 

$

16,320,288

 

 

$

5,933,702

 

Prepaids and other current assets

 

 

1,011,969

 

 

 

1,251,264

 

Total current assets

 

 

17,332,257

 

 

 

7,184,966

 

Fixed assets, net

 

 

86,470

 

 

 

93,310

 

Deferred financing costs

 

 

 

 

 

1,117,290

 

Total assets

 

$

17,418,727

 

 

$

8,395,566

 

 

 

 

 

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable

 

$

541,752

 

 

$

1,815,270

 

Accrued expenses

 

 

724,687

 

 

 

2,008,361

 

Total current liabilities

 

 

1,266,439

 

 

 

3,823,631

 

Convertible promissory notes

 

 

 

 

 

12,965,480

 

Total liabilities

 

 

1,266,439

 

 

 

16,789,111

 

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

Series A convertible preferred stock, $0.0001 par value: 10,000,000 shares authorized, none and 7,500,713 issued and outstanding as of March 31, 2023 and December 31, 2022, respectively

 

 

 

 

 

8,793,637

 

Common stock, $0.0001 par value; 200,000,000 shares authorized; 9,947,915 and 2,590,157 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively

 

 

996

 

 

 

259

 

Additional paid-in capital

 

 

36,756,301

 

 

 

681,106

 

Accumulated deficit

 

 

(20,605,009

)

 

 

(17,868,547

)

Total stockholders’ equity (deficit)

 

 

16,152,288

 

 

 

(8,393,545

)

Total liabilities and stockholders’ equity (deficit)

 

$

17,418,727

 

 

$

8,395,566

 

CONDENSED UNAUDITED INTERIM STATEMENTS OF OPERATIONS 

 

Three Months Ended March 31,

 

2023

 

2022

Operating expenses:

 

 

 

Research and development

$

1,231,712

 

 

$

978,804

 

General and administrative

 

1,661,544

 

 

 

717,524

 

Depreciation

 

6,840

 

 

 

4,033

 

Total operating expenses

 

2,900,096

 

 

 

1,700,361

 

Loss from operations

 

(2,900,096

)

 

 

(1,700,361

)

Other income (expense):

 

 

 

Other income (expense), net

 

163,634

 

 

 

(3,017

)

Net loss

$

(2,736,462

)

 

$

(1,703,378

)

 

 

 

 

Per share information:

 

 

 

Net loss per share of common stock, basic and diluted

$

(0.28

)

 

$

(0.66

)

Weighted-average shares of common stock outstanding, basic and diluted

 

9,721,847

 

 

 

2,590,098

 

About Coya Therapeutics, Inc.

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. For more information about Coya, please visit www.coyatherapeutics.com.

Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact

David Snyder

[email protected]

Hayden IR

James Carbonara

(646) 755-7412

[email protected]

Media Contact

Jessica Starman

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Research Mental Health Neurology Genetics Clinical Trials Stem Cells Biotechnology Pharmaceutical Health Science

MEDIA:

Pebblebrook Hotel Trust Completes Sale of The Hotel Monaco Seattle

Pebblebrook Hotel Trust Completes Sale of The Hotel Monaco Seattle

BETHESDA, Md.–(BUSINESS WIRE)–
Pebblebrook Hotel Trust (NYSE: PEB) (the “Company”) announced that on May 9, 2023, it closed on the sale of the 189-room Hotel Monaco Seattle in Seattle, WA for $63.3 million to a third party.

For the trailing twelve months ended March 31, 2023, the hotel’s net operating income was $1.6 million, and its Hotel EBITDA was $2.1 million, with the $63.3 million sales price reflecting a 30.7x EBITDA multiple and a 2.5% net operating income capitalization rate. Based on the hotel’s operating performance for 2019, the $63.3 million sales price reflects an 11.4x EBITDA multiple and a 7.6% net operating income capitalization rate. The net operating income for both periods mentioned above is after an assumed annual capital reserve of 4.0% of total hotel revenues.

Proceeds from the sale of Hotel Monaco Seattle will be used for general corporate purposes, which may include reducing the Company’s outstanding debt and repurchasing common and preferred shares.

About Pebblebrook Hotel Trust

Pebblebrook Hotel Trust (NYSE: PEB) is a publicly traded real estate investment trust (“REIT”) and the largest owner of urban and resort lifestyle hotels and resorts in the United States. The Company owns 48 hotels and resorts, totaling approximately 12,300 guest rooms across 14 urban and resort markets. For more information, visit www.pebblebrookhotels.com and follow us at @PebblebrookPEB.

This press release contains certain “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Reform Act of 1995. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “estimated” and “will” or other similar words or expressions. Forward-looking statements are based on certain assumptions and can include future expectations, future plans and strategies, financial and operating projections and forecasts and other forward-looking information and estimates. The intended use of proceeds is a forward-looking statement. These forward-looking statements are subject to various risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results to differ materially from such statements. These risks and uncertainties include, but are not limited to, the state of the U.S. economy, the operating performance of our hotels and the supply of hotel properties, and other factors as are described in greater detail in the Company’s filings with the Securities and Exchange Commission, including, without limitation, the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Unless legally required, the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

For further information about the Company’s business and financial results, please refer to the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” sections of the Company’s SEC filings, including, but not limited to, its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, copies of which may be obtained at the Investor Relations section of the Company’s website at www.pebblebrookhotels.com.

All information in this press release is as of May 9, 2023. The Company undertakes no duty to update the statements in this press release to conform the statements to actual results or changes in the Company’s expectations.

For additional information or to receive press releases via email, please visit our website at www.pebblebrookhotels.com.

 

Pebblebrook Hotel Trust

Hotel Monaco Seattle

Reconciliation of Hotel Net Income to Hotel EBITDA and Hotel Net Operating Income

March 2023 Trailing Twelve Months

(Unaudited, in millions)

 

 

 

 

 

 

 

Twelve Months Ended March 31,

 

 

 

2023

 
Hotel net income

$0.4

 
Adjustment:
Depreciation and amortization

1.7

 
Hotel EBITDA

$2.1

 
Adjustment:
Capital reserve

(0.5)

 
Hotel Net Operating Income

$1.6

 
 
 
This press release includes certain non-GAAP financial measures as defined under Securities and Exchange Commission (SEC) rules. These measures are not in accordance with, or an alternative to, measures prepared in accordance with U.S. generally accepted accounting principles, or GAAP, and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the hotel’s results of operations determined in accordance with GAAP.

The Company has presented estimated trailing twelve-month hotel EBITDA and estimated trailing twelve-month hotel net operating income after capital reserves because it believes these measures provide investors and analysts with an understanding of the hotel-level operating performance. These non-GAAP measures do not represent amounts available for management’s discretionary use, because of needed capital replacement or expansion, debt service obligations or other commitments and uncertainties, nor are they indicative of funds available to fund the Company’s cash needs, including its ability to make distributions.

The Company’s presentation of the hotel’s estimated trailing twelve-month EBITDA and estimated trailing twelve-month net operating income after capital reserves should not be considered as an alternative to net income (computed in accordance with GAAP) as an indicator of the hotel’s financial performance. The table above is a reconciliation of the hotel’s estimated trailing twelve-month EBITDA and net operating income after capital reserves calculations to net income in accordance with GAAP. Any differences are a result of rounding.

Pebblebrook Hotel Trust

Hotel Monaco Seattle

Reconciliation of Hotel Net Income to Hotel EBITDA and Hotel Net Operating Income

December 2019 Trailing Twelve Months

(Unaudited, in millions)

 

 

 

 

 

 

 

Twelve months ended

December 31,

 

 

 

2019

 
Hotel net income

$3.8

 
Adjustment:
Depreciation and amortization

1.8

 
Hotel EBITDA

$5.6

 
Adjustment:
Capital reserve

(0.8)

 
Hotel Net Operating Income

$4.8

 
 
This press release includes certain non-GAAP financial measures as defined under Securities and Exchange Commission (SEC) rules. These measures are not in accordance with, or an alternative to, measures prepared in accordance with U.S. generally accepted accounting principles, or GAAP, and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the hotel’s results of operations determined in accordance with GAAP.

The Company has presented trailing twelve-month hotel EBITDA and trailing twelve-month hotel net operating income after capital reserves because it believes these measures provide investors and analysts with an understanding of the hotel-level operating performance. These non-GAAP measures do not represent amounts available for management’s discretionary use, because of needed capital replacement or expansion, debt service obligations or other commitments and uncertainties, nor are they indicative of funds available to fund the Company’s cash needs, including its ability to make distributions.

The Company’s presentation of the hotel’s trailing twelve-month EBITDA and trailing twelve-month net operating income after capital reserves should not be considered as an alternative to net income (computed in accordance with GAAP) as an indicator of the hotel’s financial performance. The table above is a reconciliation of the hotel’s trailing twelve-month EBITDA and net operating income after capital reserves calculations to net income in accordance with GAAP. Any differences are a result of rounding.

Pebblebrook Hotel Trust

Historical Operating Data

($ in millions, except ADR and RevPAR)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Historical Operating Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

First Quarter

 

Second Quarter

 

Third Quarter

 

Fourth Quarter

 

Full Year

 

 

 

 

2019

 

2019

 

2019

 

2019

 

2019

 
Occupancy

75%

86%

86%

77%

81%

ADR

$255

$275

$271

$251

$264

RevPAR

$190

$236

$233

$193

$213

 
Hotel Revenues

$321.5

$398.2

$391.2

$339.2

$1,450.0

Hotel EBITDA

$86.1

$141.6

$132.6

$92.0

$452.3

Hotel EBITDA Margin

26.8%

35.6%

33.9%

27.1%

31.2%

 

First Quarter

 

Second Quarter

 

Third Quarter

 

Fourth Quarter

 

Full Year

2022

 

2022

 

2022

 

2022

 

2022

 
Occupancy

49%

69%

73%

59%

62%

ADR

$314

$327

$326

$294

$316

RevPAR

$152

$226

$237

$175

$198

 
Hotel Revenues

$257.1

$388.2

$402.7

$311.2

$1,359.2

Hotel EBITDA

$59.9

$136.0

$128.7

$61.1

$385.7

Hotel EBITDA Margin

23.3%

35.0%

32.0%

19.6%

28.4%

 

First Quarter

2023

 
Occupancy

58%

ADR

$301

RevPAR

$173

 
Hotel Revenues

$298.0

Hotel EBITDA

$58.8

Hotel EBITDA Margin

19.7%

 
 
These historical hotel operating results include information for all of the hotels the Company owned as of May 9, 2023, following the sale of Hotel Monaco Seattle. These historical operating results include periods prior to the Company’s ownership of the hotels. The information above does not reflect the Company’s corporate general and administrative expense, interest expense, property acquisition costs, depreciation and amortization, taxes and other expenses. Any differences are a result of rounding.

The information above has not been audited and has been presented only for comparison purposes.

 

Raymond D. Martz

Chief Financial Officer

Pebblebrook Hotel Trust

(240) 507-1330

KEYWORDS: Maryland United States North America

INDUSTRY KEYWORDS: REIT Lodging Commercial Building & Real Estate Construction & Property Travel

MEDIA:

Logo
Logo

BlackSky Reports First Quarter 2023 Results

BlackSky Reports First Quarter 2023 Results

Q1 Imagery and Analytics Revenue Increases 114% from Prior Year

Won Over a Dozen New Contracts and Renewal Agreements

Amended Existing Debt Facility Extending Maturity to October 2026

HERNDON, Va.–(BUSINESS WIRE)–
BlackSky Technology Inc. (“BlackSky” or the “Company”) (NYSE: BKSY) announced results for the first quarter ended March 31, 2023.

First Quarter Financial Highlights:

  • Revenue of $18.4 million, up 32% from the prior year period

  • Imagery & software analytical services revenue grew 114% over the prior year quarter with substantial operating leverage as cost of sales, as a percent of revenue, decreased to just 23% from 49% in the prior year quarter

“We’re pleased that our high-margin imagery and analytics revenue in the first quarter of 2023 grew 114% year-over-year, and coupled with strong incremental contribution margins, we maintain our trajectory towards achieving positive adjusted EBITDA in Q4 this year,” said Brian E. O’Toole, BlackSky CEO. “Since the beginning of the year, in addition to the $150+ million, multi-year subscription contract award we announced in March, we’ve also won over a dozen new contracts and renewals primarily supporting U.S. and international government agencies. These contract wins continue to demonstrate how BlackSky is increasingly relied upon by important customers around the world to deliver actionable intelligence from space. During the quarter, we also successfully launched two new satellites that provide us with additional capacity and redundancy. These satellites entered revenue-generating operations within 18 hours of launch. With the traction we’re experiencing, we believe the Company is well-positioned to capitalize on the growing demand for geospatial intelligence and are re-affirming our guidance for the year.”

Recent Highlights

  • The Company announced today an amendment to its existing debt facility extending the maturity term to October 2026 and also reducing the level of cash interest payments for the next two years

  • Continued strong sales momentum in the international markets, as BlackSky recently won multi-year, multi-million dollar contracts to provide high-frequency imagery and advanced analytics in support of various international government agencies

  • Received additional orders exercised under the Economic Indicator Monitoring program with the National Geospatial-Intelligence Agency (NGA)

  • Signed contract with a large multinational commercial customer to provide imagery and analytics for supply chain logistics intelligence

  • On March 24, the Company deployed two additional Gen-2 satellites into orbit, which began revenue-generating operations within 18 hours of launch, continuing our industry-leading ability to rapidly deploy and immediately deliver value to our customers

  • Awarded a multi-year contract by the National Reconnaissance Office (NRO) to explore commercial hyperspectral imagery capabilities

Financial Results

Revenues(1)

Total revenue for the first quarter of 2023 was $18.4 million, up $4.5 million, or 32%, from the first quarter of 2022. Imagery and software analytical services revenue was $15.8 million, up 114% over the prior year period, primarily driven by increased demand from new and existing U.S. and international government customers. Professional and engineering services revenue was $2.6 million in the first quarter of 2023 compared to $6.5 million in the prior year period. In the first quarter of 2023, the Company had two research and development programs that were nearing completion and as a result, professional and engineering services revenue was lower than the prior year quarter. Professional and engineering services contracts are milestone-based contracts that have quarter-over-quarter variability in contrast to the high-margin imagery and software analytical services, which are typically recurring subscription-based revenues.

Cost of Sales(1)(2)

Cost of sales as a percent of revenue was 35% for the first quarter of 2023, compared to 79% in the first quarter of 2022. Imagery and software analytical services cost of sales as a percent of revenue was 23% in the first quarter of 2023, compared to 49% in the first quarter of 2022. The year-over-year improvement was primarily driven by greater volumes of imagery and analytical services revenue that inherently have a low fixed-cost structure as a percent of revenue. Cost of sales excludes depreciation and amortization expense.

Operating Expenses

Operating expenses for the first quarter of 2023 were $28.8 million, which included $2.7 million of non-cash stock-based compensation expense, compared to operating expenses of $30.1 million in the first quarter of 2022, which included $9.3 million in non-cash stock-based compensation expense. Excluding stock-based compensation expense from both years, operating expenses increased to $26.1 million in the first quarter of 2023 from $20.8 million in the prior year quarter. The $5.3 million year-over-year increase was primarily due to investments in sales and software talent and higher depreciation expense.

Net Loss

Net loss for the first quarter of 2023 was $17.3 million, compared to a net loss of $20.0 million in the first quarter of 2022.

Adjusted EBITDA(3)

Adjusted EBITDA loss for the first quarter of 2023 was $4.1 million, compared to an adjusted EBITDA loss of $9.5 million in the prior year quarter. The $5.4 million year-over-year improvement was primarily a result of strong operating leverage achieved through increased revenue of high-margin imagery and analytics.

Balance Sheet & Capital Expenditures

As of March 31, 2023, cash and cash equivalents, restricted cash, and short-term investments totaled $71.6 million, which includes the Company’s previously announced private placement financing of approximately $29.5 million. Capital expenditures for the first quarter of 2023 were $15.8 million, driven by final payments for the launch of the two Gen-2 satellites deployed on March 24, 2023, as well as expected payments for Gen-3 satellite production.

2023 Outlook

The Company anticipates strong global demand for BlackSky’s products and services to continue throughout the year. As a result, the Company maintains its full year 2023 revenue outlook of between $90 million and $96 million, a 42% increase over 2022 revenue at the mid-point of this range. The Company remains on track to achieve positive Adjusted EBITDA in the fourth quarter of 2023. In addition, the Company maintains its expectations for full year 2023 capital expenditures to be between $40 million and $45 million.

(1) Effective January 1, 2022, the Company reorganized its classification on the consolidated statements of operations and comprehensive loss to better align the Company’s broad portfolio. As a result, the prior period amounts presented to reflect the impact of the reorganization have been recast.

(2) Cost of sales is defined as imagery and software analytical services costs and professional and engineering services cost, less depreciation and amortization.

(3) Non-GAAP financial measure. See “Non-GAAP Financial Measures” below and reconciliation table at the end of this release.

Investment Community Conference Call

BlackSky will host a conference call and webcast for the investment community this morning at 8:30 AM ET. Senior management will review the results, discuss BlackSky’s business, and answer questions. To access the live webcast or the archived webcast following completion of the call, please visit the Company’s investor relations website at http://ir.blacksky.com and then select “News & Events” for the link to the webcast. A presentation accompanying the webcast can also be found on the investor relations website. To access the conference call, participants should dial 1-877-589-7299 (domestic) or 1-201-689-8778 (international) at least ten minutes prior the start of the call. To listen to a replay of the conference call, please dial 1-877-660-6853 or 1-201-612-7415 using access code 13738351. The audio replay will be available from approximately 12:30 PM ET on May 10, 2023, through May 24, 2023.

About BlackSky Technology Inc.

BlackSky is a leading provider of real-time geospatial intelligence. BlackSky delivers on-demand, high frequency imagery, monitoring and analytics of the most critical and strategic locations, economic assets and events in the world.

BlackSky designs, owns and operates one of the industry’s leading low earth orbit small satellite constellations, optimized to capture imagery cost-efficiently where and when our customers need it. BlackSky’s Spectra AI software platform processes data from BlackSky’s constellation and from other third-party sensors to develop the critical insights and analytics that our customers require.

BlackSky is relied upon by U.S. and international government agencies, commercial businesses, and organizations around the world. BlackSky is headquartered in Herndon, VA, and is publicly traded on the New York Stock Exchange as BKSY. To learn more, visit www.blacksky.com and follow us on Twitter.

Non-GAAP Financial Measures

Adjusted EBITDA is defined as net income or loss attributable to BlackSky before interest income, interest expense, income taxes, depreciation and amortization, as well as significant non-cash and/or non-recurring expenses as our management believes these items are not as useful in evaluating the Company’s core operating performance. These items include, but are not limited to, stock-based compensation expense, unrealized (gain) loss on certain warrants/shares classified as derivative liabilities, severance, income on equity method investment, investment loss on short-term investments, and transaction costs associated with equity instruments accounted for as derivative liabilities.

Adjusted EBITDA is a non-GAAP financial performance measure. It should not be considered in isolation or as an alternative to measures determined in accordance with GAAP. Please refer to the schedule herein and our SEC filings for a reconciliation of Adjusted EBITDA to Net Loss, the most comparable measure reported in accordance with GAAP and for a discussion of the presentation, comparability, and use of Adjusted EBITDA.

Forward-Looking Statements

Certain statements and other information included in this release constitute forward-looking statements under applicable securities laws. Words such as “may”, “will”, “could”, “should”, “would”, “plan”, “potential”, “intend”, “anticipate”, “believe”, “estimate”, “future”, “opportunity”, “will likely result”, or “expect” and other words, terms, and phrases of similar meaning are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements involve estimates, expectations, projections, goals, forecasts, assumptions, risks, and uncertainties, as well as other statements referring to or including forward-looking information included in this release.

Forward-looking statements are subject to various risks and uncertainties, which could cause actual results to differ materially from the anticipated results or expectations expressed in this release. As a result, although BlackSky’s management believes that the expectations and assumptions on which such forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because BlackSky can give no assurance that they will prove to be correct. The risks that could cause actual results to differ materially from current expectations include, but are not limited to, the risk factors discussed in our most recent Annual Report on Form 10-K and other disclosures about BlackSky and its business included in BlackSky’s disclosure materials filed from time to time with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov or on BlackSky’s Investor Relations website at ir.blacksky.com.

The forward-looking statements contained in this release are expressly qualified in their entirety by the foregoing cautionary statements. All such forward-looking statements are based upon data available as of the date of this release or other specified date and speak only as of such date. BlackSky disclaims any intention or obligation to update or revise any forward-looking statements in this release as a result of new information or future events, except as may be required under applicable securities law.

BLACKSKY TECHNOLOGY INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

AND COMPREHENSIVE LOSS

(unaudited)

(in thousands, except per share amounts)

 

 

Three Months Ended

March 31,

 

 

2023

 

 

 

2022

 

Revenue

 

 

 

Imagery & software analytical services

$

15,760

 

 

$

7,370

 

Professional & engineering services

 

2,637

 

 

 

6,526

 

Total revenue

 

18,397

 

 

 

13,896

 

Costs and expenses

 

 

 

Imagery & software analytical service costs, excluding depreciation and amortization

 

3,699

 

 

 

3,578

 

Professional & engineering service costs, excluding depreciation and amortization

 

2,779

 

 

 

7,377

 

Selling, general and administrative

 

18,949

 

 

 

22,540

 

Research and development

 

216

 

 

 

146

 

Depreciation and amortization

 

9,655

 

 

 

7,391

 

Total costs and expenses

 

151,899

 

 

 

154,228

 

Operating loss

 

(16,901

)

 

 

(27,136

)

Gain on derivatives

 

1,531

 

 

 

8,140

 

Income on equity method investment

 

529

 

 

 

257

 

Interest income

 

435

 

 

 

 

Interest expense

 

(1,853

)

 

 

(1,255

)

Other (expense) income, net

 

(943

)

 

 

2

 

Loss before income taxes

 

(17,202

)

 

 

(19,992

)

Income tax expense

 

(113

)

 

 

 

Net loss

 

(17,315

)

 

 

(19,992

)

Other comprehensive income

 

 

 

 

 

Total comprehensive loss

$

(17,315

)

 

$

(19,992

)

 

 

 

 

Basic and diluted loss per share of common stock:

 

 

 

Net loss per share of common stock

$

(0.14

)

 

$

(0.17

)

 

 

 

 

Weighted average common shares outstanding – basic and diluted

 

124,144

 

 

 

115,479

 

Note: Effective January 1, 2022, the Company reorganized its classification on the consolidated statements of operations and comprehensive loss to better align the Company’s broad portfolio. As a result, the prior period amounts presented to reflect the impact of the reorganization have been recast.

BLACKSKY TECHNOLOGY INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands, except par value)

 

 

March 31,

2023

 

December 31,

2022

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

56,964

 

 

$

34,181

 

Restricted cash

 

2,835

 

 

 

2,835

 

Short-term investments

 

11,792

 

 

 

37,982

 

Accounts receivable, net of allowance of $0 and $0, respectively

 

9,059

 

 

 

3,112

 

Prepaid expenses and other current assets

 

4,295

 

 

 

4,713

 

Contract assets

 

6,442

 

 

 

5,706

 

Total current assets

 

91,387

 

 

 

88,529

 

Property and equipment – net

 

87,377

 

 

 

71,584

 

Operating lease right of use assets – net

 

3,343

 

 

 

3,586

 

Goodwill

 

9,393

 

 

 

9,393

 

Investment in equity method investees

 

5,814

 

 

 

5,285

 

Intangible assets – net

 

1,778

 

 

 

1,918

 

Satellite procurement work in process

 

39,581

 

 

 

50,954

 

Other assets

 

2,576

 

 

 

2,841

 

Total assets

$

241,249

 

 

$

234,090

 

Liabilities and stockholders’ equity

 

 

 

Current liabilities:

 

 

 

Accounts payable and accrued liabilities

$

10,571

 

 

$

14,368

 

Amounts payable to equity method investees

 

2,377

 

 

 

3,728

 

Contract liabilities – current

 

3,873

 

 

 

6,783

 

Other current liabilities

 

4,033

 

 

 

2,048

 

Total current liabilities

 

20,854

 

 

 

26,927

 

Liability for estimated contract losses

 

641

 

 

 

714

 

Long-term contract liabilities

 

68

 

 

 

109

 

Operating lease liabilities

 

3,082

 

 

 

3,132

 

Derivative liabilities

 

21,298

 

 

 

5,113

 

Long-term debt – net of current portion

 

76,332

 

 

 

76,219

 

Other liabilities

 

69

 

 

 

2

 

Total liabilities

 

122,344

 

 

 

112,216

 

Stockholders’ equity:

 

 

 

Class A common stock, $0.0001 par value-authorized, 300,000 shares; issued, 139,257 and 121,938 shares; outstanding, 136,839 shares and 119,508 shares as of March 31, 2023 and December 31, 2022, respectively.

 

14

 

 

 

12

 

Additional paid-in capital

 

681,317

 

 

 

666,973

 

Accumulated deficit

 

(562,426

)

 

 

(545,111

)

Total stockholders’ equity

 

118,905

 

 

 

121,874

 

Total liabilities and stockholders’ equity

$

241,249

 

 

$

234,090

 

BLACKSKY TECHNOLOGY INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

 

Three Months Ended March 31,

 

 

2023

 

 

 

2022

 

Cash flows from operating activities:

 

 

 

Net loss

$

(17,315

)

 

$

(19,992

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

Depreciation and amortization expense

 

9,655

 

 

 

7,391

 

Operating lease right of use assets amortization

 

446

 

 

 

389

 

Bad debt expense

 

 

 

 

6

 

Stock-based compensation expense

 

3,012

 

 

 

10,240

 

Amortization of debt discount and issuance costs

 

113

 

 

 

502

 

Gain on equity method investment

 

(529

)

 

 

(257

)

Gain on disposal of property and equipment

 

(22

)

 

 

 

Gain on derivatives

 

(1,531

)

 

 

(8,140

)

Interest income

 

(156

)

 

 

 

Changes in operating assets and liabilities:

 

 

 

Accounts receivable

 

(5,947

)

 

 

(2,868

)

Contract assets – current and long-term

 

(591

)

 

 

(1,187

)

Prepaid expenses and other current assets

 

462

 

 

 

1,220

 

Other assets

 

(8

)

 

 

(5

)

Accounts payable and accrued liabilities

 

(2,966

)

 

 

1,533

 

Other current liabilities

 

1,732

 

 

 

(585

)

Contract liabilities – current and long-term

 

(2,951

)

 

 

694

 

Liability for estimated contract losses

 

(73

)

 

 

(2,428

)

Other liabilities

 

67

 

 

 

811

 

Net cash used in operating activities

 

(16,602

)

 

 

(12,676

)

Cash flows from investing activities:

 

 

 

Purchase of property and equipment

 

(2,874

)

 

 

(1,926

)

Satellite procurement work in process

 

(12,926

)

 

 

(11,499

)

Purchase of short-term investments

 

(11,792

)

 

 

 

Proceeds from maturities of short-term investments

 

38,110

 

 

 

 

Net cash provided by (used in) investing activities

 

10,518

 

 

 

(13,425

)

Cash flows from financing activities:

 

 

 

Proceeds from private placement, net of equity issuance costs

 

29,432

 

 

 

 

Proceeds from options exercised

 

3

 

 

 

17

 

Payments for deferred offering costs

 

(552

)

 

 

 

Payments of transaction costs related to derivative liabilities

 

(16

)

 

 

 

Withholding tax payments on vesting of restricted stock units

 

 

 

 

(3,616

)

Net cash provided by (used in) financing activities

 

28,867

 

 

 

(3,599

)

Net increase (decrease) in cash, cash equivalents, and restricted cash

 

22,783

 

 

 

(29,700

)

Cash, cash equivalents, and restricted cash – beginning of year

 

37,016

 

 

 

168,104

 

Cash, cash equivalents, and restricted cash – end of period

$

59,799

 

 

$

138,404

 

BLACKSKY TECHNOLOGY INC.

RECONCILIATION OF NET LOSS TO ADJUSTED EBITDA

(unaudited)

(in thousands)

 

 

Three Months Ended March 31,

 

 

2023

 

 

 

2022

 

Net loss

$

(17,315

)

 

$

(19,992

)

Interest income

 

(435

)

 

 

 

Interest expense

 

1,853

 

 

 

1,255

 

Income tax expense

 

113

 

 

 

 

Depreciation and amortization

 

9,655

 

 

 

7,391

 

Stock-based compensation expense

 

3,012

 

 

 

10,240

 

Gain on derivatives

 

(1,531

)

 

 

(8,140

)

Income on equity method investment

 

(529

)

 

 

(257

)

Transaction costs associated with derivative liabilities

 

905

 

 

 

 

Severance

 

88

 

 

 

 

Investment loss on short-term investments

 

55

 

 

 

 

Adjusted EBITDA

$

(4,129

)

 

$

(9,503

)

 

Investor Contact

Aly Bonilla

VP, Investor Relations

[email protected]

571-591-2864

Media Contact

Pauly Cabellon

Director, External Communications

[email protected]

571-591-2865

KEYWORDS: Virginia United States North America

INDUSTRY KEYWORDS: Satellite Other Technology Technology Artificial Intelligence Software

MEDIA:

Logo
Logo

Seres Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Seres Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Seres Therapeutics, Inc. (Nasdaq: MCRB) (“Seres” or the “Company”), a leading microbiome therapeutics company, today announced that on May 3, 2023, the Compensation and Talent Committee of Seres’ board of directors granted inducement equity grants covering an aggregate of 19,000 shares of its common stock to four new employees, consisting of stock options to purchase an aggregate of 11,000 shares of common stock and restricted stock units (“RSUs”), covering an aggregate of 8,000 shares of its common stock.

These stock options and inducement RSUs are subject to the terms of the Seres Therapeutics, Inc. 2022 Employment Inducement Award Plan (the “Inducement Plan”).

The Inducement Plan is used exclusively for the grant of equity awards to individuals as an inducement material to their entering into employment with Seres pursuant to Nasdaq Listing Rule 5635(c)(4). The Inducement Plan was adopted by Seres’ board of directors in December 2022.

The stock options have an exercise price of $5.22 per share. Each option will vest as to 25% of the total number of shares subject to the option on the first anniversary of the applicable individual’s date of hire and as to 6.25% of the total number of shares subject to the option upon a completion of each three full months of service to the Company thereafter. The RSUs vest as to 25% of an award on the first 15th day of a calendar month that immediately follows the first anniversary of the applicable individual’s date of hire and as to an additional 6.25% of the award, upon completion of each three full months of service to the Company thereafter.

About Seres Therapeutics

Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. For more information, please visit www.serestherapeutics.com.

IR and PR

Carlo Tanzi, Ph.D.

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health Other Health Other Science Research Science Pharmaceutical Biotechnology

MEDIA:

Acorda Therapeutics to Make June 2023 $6.2 Million Interest Payment on Secured Debt in Cash

Acorda Therapeutics to Make June 2023 $6.2 Million Interest Payment on Secured Debt in Cash

PEARL RIVER, N.Y.–(BUSINESS WIRE)–
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it will make a cash interest payment of approximately $6.2 million due on June 1, 2023 under its Convertible Senior Secured Notes Indenture.

Under the terms of the Indenture, Acorda may elect to make interest payments under the Indenture in cash or shares of the Company’s common stock. The Company will make the interest payment using cash that was placed in escrow when the Notes were issued, which is reported on the Company’s balance sheet as restricted cash. By making this interest payment in cash, the Company has ensured that there will be no dilution to shareholders as a result of this payment. The June 1 payment is the last payment in which the Company has the option to pay in cash or shares. All future payments will be made in cash.

About Acorda Therapeutics

Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

Forward-Looking Statements

This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: we may not be able to successfully market INBRIJA, AMPYRA or any other products under development; the COVID-19 pandemic, including related restrictions on in-person interactions and travel, and the potential for illness, quarantines and vaccine mandates affecting our management, employees or consultants or those that work for other companies we rely upon, could have a material adverse effect on our business operations or product sales; our ability to attract and retain key management and other personnel, or maintain access to expert advisors; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures; risks associated with the trading of our common stock; risks related to the successful implementation of our business plan, including the accuracy of its key assumptions; risks related to our corporate restructurings, including our ability to outsource certain operations, realize expected cost savings and maintain the workforce needed for continued operations; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA or AMPYRA to meet market demand; our reliance on third-party manufacturers for the timely production of commercial supplies of INBRIJA and AMPYRA; third-party payers (including governmental agencies) may not reimburse for the use of INBRIJA or AMPYRA at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; reliance on collaborators and distributors to commercialize INBRIJA and AMPYRA outside the U.S.; our ability to satisfy our obligations to distributors and collaboration partners outside the U.S. relating to commercialization and supply of INBRIJA and AMPYRA; competition for INBRIJA and AMPYRA, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions because, among other reasons, acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of INBRIJA (levodopa inhalation powder) or from other research and development programs, or any other acquired or in-licensed programs; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class-action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third-party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release, except as may be required by law.

Tierney Saccavino

(917) 783-0251

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Biotechnology General Health Neurology Health Pharmaceutical

MEDIA:

Logo
Logo

Bayer and Bicycle Therapeutics Enter Strategic Collaboration for Development of Novel Targeted Radionuclide Therapies in Oncology

Bayer and Bicycle Therapeutics Enter Strategic Collaboration for Development of Novel Targeted Radionuclide Therapies in Oncology

  • Collaboration will leverage Bicycle Therapeutic’s synthetic peptides for the discovery and development of multiple targeted radioconjugates of the company in oncology

  • Advancing the use of bicycle peptides as a novel targeting approach in radiopharmaceuticals

  • Bicycle Therapeutics to receive upfront payment of USD 45 million, and potential future development and commercial-based milestones, up to a total of USD 1.7 billion, plus tiered commercial royalties

BERLIN & CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–
Bayer and Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics by utilizing proprietary bicyclic peptides technology (Bicycle®), today announced that they have entered into a strategic collaboration agreement to discover, develop, manufacture, and commercialize Bicycle radioconjugates for multiple agreed upon oncology targets.

Bicyclic peptides are peptides consisting of 9-20 amino acids that can be synthetically manufactured and bind to targets with high affinity and selectivity, affording high tumor penetration and fast excretion from healthy organs. They are chemically synthesizable, featuring a low molecular weight and tunable pharmacokinetics, with a large surface-area for molecular interactions that allows protein-protein interactions to be targeted. The two companies will jointly use Bicycle’s peptide technology to develop bicyclic peptides for several undisclosed oncology targets. Targeted radiotherapies are an innovative class of cancer therapies. Due to their unique mode of action, they have the potential to unlock a broad opportunity space and serve patients in high-unmet medical need indications.

“At Bayer, we enter strategic collaborations to expand our access to innovation,” said Christian Rommel, Ph.D., Global Head of Research and Development and Member of the Executive Committee, Pharmaceuticals Division, Bayer. “With Bicycle’s proprietary peptide-based technology, we continue to strengthen our oncology development pipeline by adding next-generation targeted radiotherapeutics to address high unmet medical needs of cancer patients.”

“Bayer is a pioneer in the radiopharmaceuticals space and provides new and additional validation of our unique technology,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “We believe our bicyclic peptide platform, coupled with Bayer’s scale and expertise in developing radiopharmaceuticals, has the potential to deliver improved clinical outcomes for patients with cancer. We look forward to collaborating with Bayer to bring forth new potential first-in-class radiopharmaceutical treatments based on Bicycles.”

Under the terms of the agreement, Bayer and Bicycle will collaborate on the development of bicyclic peptides for multiple oncology targets. Bicycle will utilize its proprietary phage platform to discover and develop bicyclic peptides and Bayer will be responsible for, and fully fund, all further preclinical and clinical development, manufacturing, and commercialization activities. Bicycle will receive a $45 million upfront payment and with potential development and commercial-based milestone fees, payments to Bicycle could total up to $1.7 billion. Bicycle will also be eligible to receive mid-single to double-digit tiered royalties on Bicycle-based medicines commercialized by Bayer. The closing of the transaction is subject to clearance of the transaction under the U.K. National Security and Investment Act 2021.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

About Bicycle Therapeutics

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC™) targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA. For more information, visit bicycletherapeutics.com.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycle’s collaboration with Bayer; the discovery, development, manufacture and potential commercialization of potential product candidates using Bicycle’s technology and under the strategic collaboration agreement; the therapeutic potential for Bicycles in oncology and other applications; and the potential to receive milestone payments and royalties under the strategic collaboration agreement. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the risk that Bicycle may not realize the intended benefits of its technology or of the collaboration agreement with Bayer, including that Bicycle and Bayer may not successfully identify, develop, manufacture and commercialize any product candidates; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements and which are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 28, 2023, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Contact for media inquiries Bayer:

Lisa Hennig, phone +49 172 869-3420

Email: [email protected]

Contact for media inquiries Bicycle:

Argot Partners

Sarah Sutton, phone +1 212-600-1902

Email: [email protected]

Contact for investor inquiries Bicycle:

SVP, Capital Markets & Corporate Communications

David Borah, CFA, phone +1 617-203-8300

Email: [email protected]

Find more information at https://pharma.bayer.com/

Follow us on Facebook: http://www.facebook.com/bayer

Follow us on Twitter: @BayerPharma

KEYWORDS: Massachusetts North America United States United Kingdom Europe Germany

INDUSTRY KEYWORDS: Research Clinical Trials Biotechnology Radiology General Health Pharmaceutical Health Science Oncology Other Science

MEDIA:

Logo
Logo

The New York Times Company Reports First-Quarter 2023 Results

The New York Times Company Reports First-Quarter 2023 Results

NEW YORK–(BUSINESS WIRE)–
The New York Times Company (NYSE: NYT) announced today that its first-quarter 2023 financial results are available on The New York Times Company’s investor relations website at investors.nytco.com.

As previously announced, The New York Times Company will host its earnings conference call today at 8:00 a.m. E.T. to discuss these financial results. A live webcast of the earnings conference call will be available at investors.nytco.com. Participants can pre-register for the telephone conference at https://dpregister.com/sreg/10177106/f8d189f90e, which will generate dial-in instructions allowing participants to bypass an operator at the time of the call. Alternatively, to access the call without pre-registration, dial 844-413-3940 (in the U.S.) or 412-858-5208 (international callers).

An archive of the webcast will be available beginning about two hours after the call at investors.nytco.com. An audio replay will be available at 877-344-7529 (in the U.S.) and 412-317-0088 (international callers) beginning approximately two hours after the call until 11:59 p.m. E.T. on Wednesday, May 24. The passcode is 3194525.

About The New York Times Company

The New York Times Company (NYSE: NYT) is a trusted source of quality, independent journalism whose mission is to seek the truth and help people understand the world. With more than 9 million subscribers across a diverse array of print and digital products — from news to cooking to games to sports — The Times has evolved from a local and regional news leader into a diversified media company with curious readers, listeners and viewers around the globe. Follow news about the company at NYTCo.com.

This press release can be downloaded from www.nytco.com.

Investors: Olivia Bloch, 212-556-1325; [email protected]

Media: Danielle Rhoades Ha, 212-556-8719, [email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Media Communications Publishing

MEDIA:

CareMax Reports First Quarter 2023 Results

CareMax Reports First Quarter 2023 Results

  • First Quarter Medicare Advantage Membership of 95,500, up 181% year-over-year
  • First Quarter Total Revenue of $173.0 million, up 26% year-over-year
  • Reaffirming Full Year 2023 Guidance

MIAMI–(BUSINESS WIRE)–
CareMax, Inc. (NASDAQ: CMAX; CMAXW) (“CareMax” or the “Company”), a leading technology-enabled value-based care delivery system, today announced financial results for the first quarter ended March 31, 2023.

“We continued to execute on our national expansion strategy and delivered strong operational performance during the quarter. However, we had two prior period developments that had an unfavorable financial impact on our first quarter results. Looking ahead, we’re encouraged by our run-rates for revenue and adjusted EBITDA exiting the quarter, and are reaffirming our full year 2023 guidance,” said Carlos de Solo, Chief Executive Officer.

First Quarter 2023 Results

  • Total Value-Based Care membership of 268,000, up 274% year-over-year.

  • Medicare Advantage Membership of 95,500, up 181% year-over-year.

  • Total revenue was $173.0 million, up 26% year-over-year.

  • Net loss was $82.1 million, compared to net loss of $16.8 million for the first quarter of 2022.1
  • Adjusted EBITDA was negative $0.1 million, compared to $3.8 million for the first quarter of 2022.2
  • Platform Contribution was $24.7 million, compared to $17.2 million for the first quarter of 2022.2
  • Medical Expense Ratio was 75.2%, compared to 72.6% for the first quarter of 2022.

  • De novo pre-opening costs and post-opening losses for the first quarter of 2023 were $5.9 million.3

Financial Outlook for Full Year 2023

CareMax is reaffirming the following full year 2023 financial guidance:

  • Year-end Medicare Advantage membership of 110,000 to 120,000, up 18% to 28% year-over-year.

  • Total revenue of $700 million to $750 million, up 11% to 19% year-over-year.

  • Adjusted EBITDA of $25 million to $35 million, up 13% to 59% year-over-year, compared to $22 million for the year-ended December 31, 2022. De novo pre-opening costs and post-opening losses are no longer added back to the Company’s calculation of Adjusted EBITDA, and are anticipated to be approximately $25 million in 2023.

1 Net loss in the first quarter of 2023 includes a $98.0 million non-cash goodwill impairment, partially offset by a $36.1 million non-cash gain on remeasurement of contingent earnout liabilities.

2 Adjusted EBITDA and Platform Contribution are non-GAAP financial metrics. A reconciliation of non-GAAP metrics to the most directly comparable GAAP financial measures is included in the appendix to this earnings release.

3 De novo pre-opening costs represent (1) incremental payroll costs from employees specifically associated with the operational, contractual, physical, or regulatory infrastructure for de novo centers, prior to their opening; (2) legal costs incurred directly associated with the de novo centers, prior to their opening, which includes services such as execution of leases, health plan contracts and other agreements; (3) other expenses related to diligence, design, permitting, and other “soft costs” at new sites; and (4) rent and facility expenses prior to center opening. De novo post-opening losses include center-level operating losses recognized at a de novo center until the center breaks even, up to 18 months after opening, which consist of revenue, external provider costs and cost of care allocated for the de novo center.

Conference Call Details

Management will host a conference call at 8:30 am ET today to discuss the results. The conference call can be accessed by dialing (888) 330-2508 for U.S. participants, or (240) 789-2735 for international participants, and referencing conference ID 7874605. A live audio webcast as well as related presentation materials will also be available on the “Events & Presentations” section of CareMax’s investor relations website at ir.caremax.com. Following the live call, a replay will be available on the Company’s website.

About CareMax

Founded in 2011, CareMax is a value-based care delivery system that utilizes a proprietary technology-enabled platform and multi-specialty, whole person health model to deliver comprehensive, preventative and coordinated care for its members. With over 200,000 Medicare Value-Based Care Members across 10 states, and fully integrated, Five-Star Quality rated health and wellness centers, CareMax is redefining healthcare across the country by reducing costs, improving overall outcomes and promoting health equity for seniors. Learn more at www.caremax.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements include statements regarding our future growth, strategy and financial performance. Words such as “anticipate,” “believe,” “budget,” “contemplate,” “continue,” “could,” “envision,” “estimate,” “expect,” “guidance,” “indicate,” “intend,” “may,” “might,” “plan,” “possibly,” “potential,” “predict,” “probably,” “pro forma,” “project,” “seek,” “should,” “target,” or “will,” or the negative or other variations thereof, and similar words or phrases or comparable terminology, are intended to identify forward-looking statements. These forward-looking statements reflect the Company’s expectations, plans or forecasts of future events and views as of the date of this press release. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements.

Important risks and uncertainties that could cause the Company’s actual results and financial condition to differ materially from those indicated in forward-looking statements include, among others, the Company’s ability to integrate acquired businesses, including the ability to implement business plans, forecasts, and other expectations after the completion of the Steward transaction; the failure to realize anticipated benefits of the Steward transaction or to realize estimated pro forma results and underlying assumptions; the impact of COVID-19 or any variant thereof or any other pandemic or epidemic on the Company’s business and results of operation; the Company’s ability to attract new patients; the availability of sites for de novo centers and the costs of opening such de novo centers; changes in market or industry conditions, regulatory environment, competitive conditions, and receptivity to the Company’s services; the Company’s ability to continue its growth, including in new markets; changes in laws and regulations applicable to the Company’s business, in particular with respect to Medicare Advantage and Medicaid; the Company’s ability to maintain its relationships with health plans and other key payers; any delay, modification or cancellation of government contracts; the Company’s future capital requirements and sources and uses of cash, including funds to satisfy its liquidity needs and the Company’s ability to comply with the covenants under the agreements governing its indebtedness; the Company’s ability to address the material weakness in its internal control over financial reporting; the Company’s ability to recruit and retain qualified team members and independent physicians; risks related to future acquisitions; the Company’s ability to develop and maintain proper and effective internal control over financial reporting and the impact of any prior period developments. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s reports filed with the SEC. All information provided in this press release is as of the date hereof, and the Company undertakes no duty to update or revise this information unless required by law, and forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this press release.

Use of Non-GAAP Financial Information

Certain financial information and data contained in this press release is unaudited and does not conform to Regulation S-X. Accordingly, such information and data may not be included in, may be adjusted in, or may be presented differently in, any periodic filing, information or proxy statement, or prospectus or registration statement to be filed by the Company with the SEC. Some of the financial information and data contained in this press release, such as Adjusted EBITDA and Platform Contribution and margin thereof have not been prepared in accordance with United States generally accepted accounting principles (“GAAP”). These non-GAAP measures of financial results are not GAAP measures of our financial results or liquidity and should not be considered as an alternative to net income (loss) as a measure of financial results, cash flows from operating activities as a measure of liquidity, or any other performance measure derived in accordance with GAAP. The Company believes these non-GAAP measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. The Company’s management uses these non-GAAP measures for trend analyses and for budgeting and planning purposes.

The Company believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating projected operating results and trends in and in comparing the Company’s financial measures with other similar companies, many of which present similar non-GAAP financial measures to investors. Management does not consider these non-GAAP measures in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of these non-GAAP financial measures is that they exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management about which expenses and income are excluded or included in determining these non-GAAP financial measures. For this reason, these non-GAAP measures may not be comparable to other companies’ similarly labeled non-GAAP financial measures. In order to compensate for these limitations, management presents non-GAAP financial measures in connection with GAAP results.

A reconciliation for Adjusted EBITDA and Platform Contribution to the most directly comparable GAAP financial measures is included below. A reconciliation of projected 2023 Adjusted EBITDA to the most directly comparable GAAP financial measure is not included in this press release because, without unreasonable efforts, the Company is unable to predict with reasonable certainty the amount or timing of non-GAAP adjustments that are used to calculate this. In addition, the Company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on the Company’s future GAAP results.

Use of Pro Forma Financial Information and Pro Forma Non-GAAP Financial Information

Certain of the information presented in the Non-GAAP Financial Summary and in the reconciliations to non-GAAP financial measures includes pro forma information derived from the unaudited pro forma statements of operations which are provided for informational purposes only and are not necessarily indicative of the operating results or financial position that would have occurred if the acquisitions of IMC and Care Holdings had occurred in the stated historical periods, nor are they indicative of the future results or financial position of the combined company. The unaudited pro forma statements of operations do not give effect to the potential impact of any anticipated synergies, operating efficiencies or cost savings that may result from the acquisitions of IMC and Care Holdings, any integration costs or tax deductibility of transaction costs.

Additionally, Adjusted EBITDA presented on a pro forma basis gives effect to the acquisitions of IMC and Care Holdings as if they had occurred in historical periods. Such non-GAAP financial measures do not necessarily reflect what the Company’s Adjusted EBITDA would have been had the acquisitions occurred on the dates indicated.

CAREMAX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(Unaudited)

 

 

 

March 31,

2023

 

 

December 31,

2022

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

44,222

 

 

$

41,626

 

Accounts receivable, net

 

 

158,989

 

 

 

151,036

 

Risk settlement assets

 

 

858

 

 

 

707

 

Other current assets

 

 

5,928

 

 

 

3,968

 

Total Current Assets

 

 

209,998

 

 

 

197,336

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

22,726

 

 

 

21,006

 

Operating lease right-of-use assets

 

 

115,018

 

 

 

108,937

 

Goodwill, net

 

 

602,643

 

 

 

700,643

 

Intangible assets, net

 

 

118,189

 

 

 

123,585

 

Deferred debt issuance costs

 

 

1,842

 

 

 

1,685

 

Other assets

 

 

27,286

 

 

 

17,550

 

Total Assets

 

$

1,097,701

 

 

$

1,170,743

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

Accounts payable

 

$

8,134

 

 

$

7,687

 

Accrued expenses

 

 

18,602

 

 

 

18,631

 

Risk settlement liabilities

 

 

13,868

 

 

 

14,171

 

Related party debt, net

 

 

31,548

 

 

 

30,277

 

Current portion of third-party debt, net

 

 

274

 

 

 

253

 

Current portion of operating lease liabilities

 

 

3,898

 

 

 

5,512

 

Other current liabilities

 

 

4,103

 

 

 

790

 

Total Current Liabilities

 

 

80,428

 

 

 

77,322

 

Derivative warrant liabilities

 

 

2,868

 

 

 

3,974

 

Long-term debt, net

 

 

260,642

 

 

 

230,725

 

Long-term operating lease liabilities

 

 

106,291

 

 

 

96,539

 

Contingent earnout liability

 

 

98,425

 

 

 

134,561

 

Other liabilities

 

 

9,283

 

 

 

8,075

 

Total Liabilities

 

 

557,938

 

 

 

551,196

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Preferred stock (1,000,000 shares authorized; one share issued and outstanding as of March 31, 2023 and December 31, 2022)

 

 

 

 

 

 

Class A common stock ($0.0001 par value; 250,000,000 shares authorized; 111,360,802 and 111,332,584 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively)

 

 

11

 

 

 

11

 

Additional paid-in-capital

 

 

659,424

 

 

 

657,126

 

Accumulated deficit

 

 

(119,672

)

 

 

(37,590

)

Total Stockholders’ Equity

 

 

539,763

 

 

 

619,547

 

 

 

 

 

 

 

 

Total Liabilities and Stockholders’ Equity

 

$

1,097,701

 

 

$

1,170,743

 

CAREMAX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Revenue

 

 

 

 

 

 

Medicare risk-based revenue

 

$

121,593

 

 

$

107,747

 

Medicaid risk-based revenue

 

 

25,626

 

 

 

20,165

 

Government value-based care revenue

 

 

10,010

 

 

 

 

Other revenue

 

 

15,754

 

 

 

9,008

 

Total revenue

 

 

172,983

 

 

 

136,920

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

External provider costs

 

 

110,673

 

 

 

92,856

 

Cost of care

 

 

38,627

 

 

 

27,349

 

Sales and marketing

 

 

3,765

 

 

 

3,301

 

Corporate, general and administrative

 

 

23,945

 

 

 

18,978

 

Depreciation and amortization

 

 

6,576

 

 

 

5,062

 

Goodwill impairment

 

 

98,000

 

 

 

 

Acquisition related costs

 

 

20

 

 

 

266

 

Total operating expenses

 

 

281,606

 

 

 

147,811

 

Operating loss

 

 

(108,623

)

 

 

(10,890

)

Nonoperating income (expense)

 

 

 

 

 

 

Interest expense, net

 

 

(10,458

)

 

 

(1,728

)

Change in fair value of derivative warrant liabilities

 

 

1,107

 

 

 

(3,536

)

Gain (loss) on remeasurement of contingent earnout liabilities

 

 

36,136

 

 

 

 

Other income (expense), net

 

 

(66

)

 

 

(462

)

 

 

 

26,718

 

 

 

(5,726

)

Loss before income tax

 

 

(81,904

)

 

 

(16,616

)

Income tax expense

 

 

(177

)

 

 

(181

)

Net loss

 

$

(82,082

)

 

$

(16,797

)

 

 

 

 

 

 

 

Weighted-average basic shares outstanding

 

 

111,360,802

 

 

 

87,367,972

 

Weighted-average diluted shares outstanding

 

 

111,360,802

 

 

 

87,367,972

 

Net loss per share

 

 

 

 

 

 

Basic

 

$

(0.74

)

 

$

(0.19

)

Diluted

 

$

(0.74

)

 

$

(0.19

)

CAREMAX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

Net loss

 

$

(82,082

)

 

$

(16,797

)

Adjustments to reconcile net loss to net cash and cash equivalents

 

 

 

 

 

 

Depreciation and amortization expense

 

 

6,576

 

 

 

5,062

 

Amortization of debt issuance costs and discounts

 

 

1,839

 

 

 

378

 

Stock-based compensation expense

 

 

2,298

 

 

 

1,087

 

Income tax provision

 

 

177

 

 

 

181

 

Change in fair value of derivative warrant liabilities

 

 

(1,107

)

 

 

3,536

 

Loss (gain) on remeasurement of contingent earnout liabilities

 

 

(36,136

)

 

 

 

Payment-in-kind interest expense

 

 

2,453

 

 

 

 

Provision for credit losses

 

 

(104

)

 

 

 

Goodwill impairment

 

 

98,000

 

 

 

 

Other non-cash, net

 

 

1,080

 

 

 

21

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(7,850

)

 

 

(10,992

)

Other current assets

 

 

(1,961

)

 

 

(627

)

Risk settlement assets and liabilities

 

 

(454

)

 

 

(84

)

Other assets

 

 

(9,735

)

 

 

(52

)

Operating lease assets and liabilities

 

 

1,445

 

 

 

 

Accounts payable

 

 

(500

)

 

 

1,470

 

Accrued expenses

 

 

(29

)

 

 

3,675

 

Other liabilities

 

 

4,343

 

 

 

1,002

 

Net cash used in operating activities

 

 

(21,746

)

 

 

(12,139

)

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

Purchase of property and equipment

 

 

(2,286

)

 

 

(1,467

)

Net cash used in investing activities

 

 

(2,286

)

 

 

(1,467

)

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

Proceeds from borrowings on long-term debt, net

 

 

27,000

 

 

 

 

Principal payments of debt

 

 

(25

)

 

 

(1,570

)

Payments of debt issuance costs

 

 

(348

)

 

 

 

Net cash provided by (used in) financing activities

 

 

26,627

 

 

 

(1,570

)

 

 

 

 

 

 

 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 

 

2,596

 

 

 

(15,176

)

Cash and cash equivalents – beginning of period

 

 

41,626

 

 

 

47,917

 

CASH AND CASH EQUIVALENTS – END OF PERIOD

 

$

44,222

 

 

$

32,740

 

 

Non-GAAP Financial Summary

Three Months Ended March 31,

 

$ in thousands

2023

 

2022

 

Medicare risk-based revenue

$

121,593

 

$

107,747

 

Medicaid risk-based revenue

 

25,626

 

 

20,165

 

Government value-based care revenue

 

10,010

 

 

 

Other revenue

 

15,754

 

 

9,008

 

Total revenue

 

172,983

 

 

136,920

 

External provider costs

 

110,673

 

 

92,856

 

Cost of care

 

37,627

 

 

26,854

 

Platform contribution

 

24,683

 

 

17,210

 

Platform contribution margin (%)

 

14.3

%

 

12.6

%

 

 

 

 

 

Sales and marketing

$

3,765

 

$

3,301

 

Corporate, general and administrative

 

20,979

 

 

10,139

 

Adjusted operating expenses

 

24,744

 

 

13,440

 

 

 

 

 

 

Adjusted EBITDA

$

(61

)

$

3,769

 

Reconciliation to Adjusted EBITDA

Three Months Ended March 31,

 

(in thousands)

2023

 

2022

 

Net Loss

$

(82,082

)

$

(16,797

)

Interest expense, net

 

10,458

 

 

1,728

 

Depreciation and amortization

 

6,576

 

 

5,062

 

Remeasurement of warrant and contingent earnout liabilities

 

(37,242

)

 

3,536

 

Goodwill impairment

 

98,000

 

 

 

Stock-based compensation

 

2,298

 

 

1,087

 

Business Combination integration costs (1)

 

1,066

 

 

5,114

 

Acquisition and integration related costs (2)

 

622

 

 

3,429

 

Other (3)

 

66

 

 

430

 

Income tax provision (benefit)

 

177

 

 

181

 

Adjusted EBITDA

$

(61

)

$

3,769

 

 

 

 

 

 

Memo:

 

 

 

 

De Novo Pre-Opening Costs

$

1,975

 

$

973

 

De Novo Post-Opening Costs

 

3,885

 

 

1,119

 

(1)

Represents initial costs to set up public company processes, incremental compensation and vendor expenses identified as temporary or duplicative and expected to be rationalized in the short term, and legal and professional expenses outside of the ordinary course of business, which are being incurred as part of the Company’s efforts as it integrates the two privately held companies that were combined in the Business Combination. Significant components of Business Combination integration costs were as follows:

 

Three Months Ended March 31,

 

 

2023

 

2022

 

Consulting and legal fees (a)

$

282

 

$

3,190

 

Compensation costs (b)

 

351

 

 

760

 

Other (c)

 

433

 

 

1,164

 

 

$

1,066

 

$

5,114

 

(a) Represents consulting and legal costs directly associated with efforts related to integration of the two privately held companies that were combined in the Business Combination.

(b) Represents incremental compensation expense directly associated with efforts related to integration of the two privately held companies that were combined in the Business Combination.

(c) Represents primarily vendor expenses identified as temporary or duplicative and/or expenses outside the ordinary course of business and not necessary to run the Company’s business.

(2)

Includes all costs recognized in acquisition related costs in our consolidated statements of operations and incremental payroll compensation expense for employees directly associated with services to achieve synergies related to closed transactions. Significant components of acquisition and integration related costs were as follows:

 

Three Months Ended March 31,

 

 

2023

 

2022

 

Advisor and other professional fees (a)

$

42

 

$

1,622

 

Compensation costs (b)

 

580

 

 

1,808

 

 

$

622

 

$

3,429

 

(a) Includes payments to our third-party transaction advisory firm associated with transaction contracts, including the Steward transaction that was closed in November 2022. Also, costs include legal and accounting fees directly associated with contemplated or closed transactions.

(b) Includes incremental payroll compensation expense for employees directly associated with services to achieve synergies related to closed transactions.

(3)

Components of other were as follows:

 

 

Three Months Ended March 31,

 

(in thousands)

 

2023

 

2022

 

Tax-related costs

 

$

 

$

265

 

Other

 

 

66

 

 

165

 

 

 

$

66

 

$

430

 

 

 

 

 

 

Non-GAAP Operating Metrics

Mar 31, 2023

 

Mar 31, 2022

 

Centers

 

62

 

 

48

 

Markets

 

7

 

 

6

 

Patients (MCREM)*

 

225,100

 

 

50,600

 

Patients in value-based care arrangements (MCREM)

 

99.0

%

 

79.8

%

Platform Contribution ($, millions)

$

24.7

 

$

17.2

 

* MCREM defined as Medicare Equivalent Members, which assumes the level of support received by a Medicare patient is equivalent to that received by three Medicaid or Commercial patients.

 

Reconciliation to Platform Contribution

 

 

Three Months Ended March 31,

 

(in millions)

2023

 

2022

 

Gross profit (a)

$

17.1

 

$

11.2

 

Depreciation and amortization

 

6.6

 

 

5.1

 

Stock-based compensation

 

1.0

 

 

0.4

 

Other adjustments (b)

 

 

 

0.5

 

Platform Contribution

$

24.7

 

$

17.2

 

 

 

 

 

 

(a) Gross profit reflects the reclassification of stock-based compensation expense previously included in corporate, general and administrative expenses, which decreased gross profit by $0.4 million for the three months ended March 31, 2022.

 

 

 

(b) Represents incremental costs relating to one-time operational projects.

 

Calculation of the Medical Expense Ratio

 

Three Months Ended March 31,

 

 

2023

 

2022

 

External provider costs

$

110,673

 

$

92,856

 

Medicare and Medicaid risk-based revenue

 

147,219

 

 

127,912

 

Medical Expense Ratio

 

75.2

%

 

72.6

%

 

Investor Relations

Samantha Swerdlin

(847) 924-8980

[email protected]

Media

Christine Bucan

(305) 542-8855

[email protected]

KEYWORDS: Florida United States North America

INDUSTRY KEYWORDS: Health Consumer Technology Health Technology Seniors Managed Care Software

MEDIA:

Logo
Logo