Exhibit 99.1

 

Picture 3

 

 

Strongbridge Biopharma plc Reports Second Quarter 2019 Financial Results and Provides Corporate Update

 

~ KEVEYIS® (dichlorphenamide) Second Quarter 2019 Revenue of $6.1 Million ~

 

~ Company on Track to Meet Full-Year 2019 KEVEYIS® Revenue Guidance of $18 to $20 Million ~

 

~ Enrollment in Phase 3 LOGICS Study for RECORLEV™ (levoketoconazole) Progressing with Top-Line Data Anticipated at the End of the First Quarter 2020 ~

 

Dublin, Ireland and Trevose, Pa., July 31, 2019

– Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today reported financial results for the second quarter of 2019 and provided a corporate update.

 

“We are encouraged by the quarter-over-quarter revenue growth achieved with KEVEYIS® (dichlorphenamide) during the second quarter of 2019. These results reflect the progress the Company has made in more fully addressing the unmet needs of the primary periodic paralysis community,” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. “Additionally, the knowledge we are gaining from our experience with KEVEYIS will be instrumental as we prepare for the potential approval and launch of RECORLEV™ (levoketoconazole) for endogenous Cushing’s syndrome.”

 

Second Quarter 2019 and Recent Corporate & Financial Highlights

 

Rare Neuromuscular Franchise: KEVEYIS® (dichlorphenamide)

 

·

Achieved KEVEYIS net product sales of $6.1 million during the second quarter of 2019, a 42 percent increase compared to $4.3 million during the second quarter of 2018.

·

Reiterated full-year 2019 revenue guidance for KEVEYIS of $18 to $20 million; based upon current assumptions, the Company anticipates a positive KEVEYIS contribution margin by the end of the first quarter of 2020.

·

In May, Strongbridge presented long-term efficacy results for KEVEYIS at the 71st American Academy of Neurology Annual Meeting. The results demonstrated that long-term treatment with KEVEYIS is efficacious and provides durable reduction in attack frequency and severity in patients with primary periodic paralysis.

 

Rare Endocrine Franchise: RECORLEV™ (levoketoconazole)

 

·

Top-line data from the Phase 3 LOGICS study anticipated at the end of the first quarter of 2020; these data will support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration projected at the end of the third quarter of 2020.

·

In April, Strongbridge presented secondary endpoint results from the Phase 3 SONICS study demonstrating meaningful improvements in the clinical signs and symptoms of Cushing’s syndrome at the 2019 American Association of Clinical Endocrinologists Annual Scientific and Clinical Congress.

 

Corporate:

 

·

In July, Strongbridge was added to the U.S. broad-market Russell 3000® and Microcap® Indexes.

·

In June, Strongbridge announced that it strengthened its senior leadership team with the promotion of Scott Wilhoit to chief commercial officer and the appointment of Marcy Nanus to vice president of corporate affairs.

·

Strongbridge had $86.2 million of cash and cash equivalents and no debt outstanding as of June 30, 2019. The Company believes the combination of existing cash resources, along with anticipated KEVEYIS revenues and payments from Novo Nordisk, are sufficient to fund operations as currently planned at least through the first quarter of 2021.

 

Second Quarter 2019 Financial Results

 

For the three months ended June 30, 2019, basic net loss attributable to ordinary shareholders on a GAAP basis was $8.2 million, or $0.15 per share, compared to a basic net loss attributable to ordinary shareholders of $2.9 million, or $0.06 per share, for the same period in 2018. Net loss for the three months ended June 30, 2019 was higher than the same period in 2018 primarily due to an unrealized gain of $19.0 million on the fair value of warrants recorded in 2018 (compared to an unrealized gain of $8.7 million on the fair value of warrants recorded in the same period of 2019) and higher research and development expenses associated with the continued development of RECORLEV, offset in part by lower selling, general, and administrative expenses primarily due to MACRILEN™ (macimorelin) launch preparation activities in 2018, as well as higher KEVEYIS net revenues for the three months ended June 30, 2019. In addition, during the three months ended June 30, 2018, the Company recorded $3.3 million of interest expense on previously outstanding long-term debt. The debt was fully repaid in the fourth quarter of 2018 and, therefore, the Company recorded no interest expense during the three months ended June 30, 2019.

 

For the three months ended June 30, 2019, non-GAAP basic net loss attributable to ordinary shareholders was $13.1 million, or $0.24 per share, compared to a non-GAAP basic net loss attributable to ordinary shareholders of $16.7 million, or $0.36 per share, for the same period in 2018. The decrease in non-GAAP net loss during the three months ended June 30, 2019 was primarily due to interest expense recorded in 2018, lower selling, general, and administrative expenses in 2019, and higher net revenues from KEVEYIS product sales in 2019, offset in part by higher research and development expenses in 2019.

 

The Company recorded net revenues from sales of KEVEYIS of $6.1 million for the three months ended June 30, 2019, compared to net revenues of $4.3 million for the same period in 2018.  The Company recorded cost of goods sold of $1.0 million for the three months ended June 30, 2019, compared to cost of goods sold of $0.8 million for the same period in 2018.

 

Selling, general and administrative expenses were $12.2 million for the three months ended June 30, 2019, compared to $15.2 million for the same period in 2018.  The decrease during the 2019 period was primarily due to MACRILEN launch preparation activities conducted in 2018.

 

Research and development expenses were $8.7 million for the three months ended June 30, 2019, compared to $5.5 million for the same period in 2018. The increase during the 2019 period was primarily due to expenses related to the RECORLEV LOGICS clinical trial and other RECORLEV development activities.

 

Year-to-Date June 2019 Financial Results

 

For the six months ended June 30, 2019, basic net loss attributable to ordinary shareholders on a GAAP basis was $26.7 million, or $0.49 per share, compared to a basic net loss attributable to ordinary shareholders of $31.6 million, or $0.69 per share, for the same period in 2018. Net loss for the six months ended June 30, 2019 was lower than the same period in 2018 primarily due to $6.2 million of interest expense and a $0.5 million loss on extinguishment of debt recorded during the six months ended June 30, 2018. The debt was fully repaid in the fourth quarter of 2018 and, therefore, the Company recorded no interest expense or loss on extinguishment of debt during the six months ended June 30, 2019. In addition, selling, general, and administrative expenses during the six months ended June 30, 2019 were lower compared to the same period in 2018, primarily due to MACRILEN launch preparation activities in 2018.  Finally, KEVEYIS revenues were higher for the six months ended June 30, 2019 compared to the same period in 2018. This was offset in part by higher research and development expenses recorded for the six months ended June 30, 2019 associated with the continued development of RECORLEV.

 

For the six months ended June 30, 2019, non-GAAP basic net loss attributable to ordinary shareholders was $26.2 million, or $0.48 per share, compared to a non-GAAP basic net loss attributable to ordinary shareholders of $31.0 million, or $0.68 per share, for the same period in 2018. The decrease in non-GAAP net loss during the six months ended June 30, 2019 was primarily due to interest expense recorded in 2018, lower selling, general, and administrative expenses in 2019, and higher net revenues from KEVEYIS product sales in 2019, offset in part by higher research and development expenses in 2019 primarily associated with the continued development of RECORLEV.

 

The Company recorded net revenues from sales of KEVEYIS of $10.4 million for the six months ended June 30, 2019, compared to net revenues of $8.2 million for the same period in 2018.  The Company recorded cost of goods sold of $1.8 million for the six months ended June 30, 2019, compared to cost of goods sold of $1.4 million for the same period in 2018.

 

Selling, general and administrative expenses were $24.3 million for the six months ended June 30, 2019, compared to $27.6 million for the same period in 2018. The decrease during the 2019 period was primarily due to MACRILEN launch preparation activities conducted in 2018. 

 

Research and development expenses were $15.3 million for the six months ended June 30, 2019, compared to $10.3 million for the same period in 2018. The increase during the 2019 period was primarily due to expenses related to the RECORLEV LOGICS clinical trial and other RECORLEV development activities.

 

Conference Call Details

Strongbridge will host a conference call on Wednesday, July 31 at 8:30 a.m. ET. To access the live call, dial 844-285-7153 (domestic) or 478-219-0180 (international) with conference ID 8196543. The conference call will also be audio webcast from the Company’s website at www.strongbridgebio.com under the “Investor/Webcasts and Presentations” section. A replay of the call will be made available for one week following the conference call. To hear a replay of the call, dial 855-859-2056 (domestic) or 404-537-3406 (international) with conference ID 8196543. 

 

About Strongbridge Biopharma

Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge’s rare endocrine franchise includes RECORLEV™ (levoketoconazole), a cortisol synthesis inhibitor currently being studied in Phase 3 clinical studies for the treatment of endogenous Cushing’s syndrome, and veldoreotide extended release, a pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation. Both RECORLEV and veldoreotide have received orphan drug designation from the FDA and the European Medicines Agency. The Company’s rare neuromuscular franchise includes KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis. KEVEYIS has orphan drug exclusivity in the United States.

 

About RECORLEV

RECORLEV™ (levoketoconazole) is an investigational cortisol synthesis inhibitor in development for the treatment of patients with endogenous Cushing’s syndrome, a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. RECORLEV is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. RECORLEV is believed to significantly suppress serum cortisol in healthy subjects and has the potential to be a next-generation cortisol inhibitor.

The Phase 3 program for RECORLEV consists of SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints, demonstrating a statistically significant normalization rate of urinary free cortisol at six months. The ongoing LOGICS study is a double-blind, placebo-controlled randomized-withdrawal study of RECORLEV that is designed to supplement the long-term efficacy and safety information supplied by SONICS.

RECORLEV has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.

 

About KEVEYIS

KEVEYIS® (dichlorphenamide) is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. In clinical studies, the most common side effects of KEVEYIS were a numbness or tingling, difficulty thinking and paying attention, changes in taste, and confusion. These are not all of the possible side effects that you may experience with KEVEYIS. Talk to your doctor if you have any symptoms that bother you or do not go away. You are encouraged to report side effects to Strongbridge Biopharma at 1-855-324-8912, or to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch/. For additional KEVEYIS important safety information and the full prescribing information visit www.keveyis.com.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements, including statements related to the potential advantages of RECORLEV, the anticipated timing for the release of top-line data from the LOGICS study and the submission of an NDA for RECORLEV to the FDA, Strongbridge’s strategy, plans, status and results of clinical trials, outcomes of product development efforts and objectives of management for future operations. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statement, including risks and uncertainties associated with clinical development and the regulatory approval process, the reproducibility of any reported results showing the benefits of RECORLEV, the adoption of RECORLEV by physicians, if approved, as treatment for any disease and the emergence of unexpected adverse events following regulatory approval and use of the product by patients.  Additional risks and uncertainties relating to Strongbridge and its business can be found under the heading “Risk Factors” in Strongbridge’s Annual Report on Form 10-K for the year ended December 31, 2018 and subsequent filings with the SEC. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.

 

Contacts:

 

Corporate and Investor Relations
Strongbridge Biopharma plc
Marcy Nanus
+1 610-263-2252
m.nanus@strongbridgebio.com

 

Media Relations
Elixir Health Public Relations
Lindsay Rocco

+1 862-596-1304
lrocco@elixirhealthpr.com

 

 

STRONGBRIDGE BIOPHARMA plc

Select Consolidated Balance Sheet Information (unaudited)

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

June 30,

 

December 31,

 

    

2019 

    

2018 

 

 

( in thousands)

Consolidated Balance Sheet Data:

 

 

  

 

 

  

Cash and cash equivalents

 

$

86,167 

 

$

122,490 

Total assets

 

 

135,156 

 

 

170,285 

Total liabilities

 

 

43,867 

 

 

57,330 

Total stockholders' equity

 

 

91,289 

 

 

112,955 

 

STRONGBRIDGE BIOPHARMA plc

Consolidated Statement of Operations (unaudited)

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

    

2019

    

2018

    

2019

    

2018

Consolidated Statement of Operations Data:

 

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Net product sales

 

$

6,073 

 

$

4,296 

 

$

10,406 

 

$

8,166 

Royalty revenues

 

 

 

 

— 

 

 

16 

 

 

— 

Total revenues

 

 

6,079 

 

 

4,296 

 

 

10,422 

 

 

8,166 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales (excluding amortization of intangible assets)

 

$

1,022 

 

$

753 

 

$

1,835 

 

$

1,420 

Selling, general and administrative

 

 

12,182 

 

 

15,210 

 

 

24,282 

 

 

27,572 

Research and development

 

 

8,739 

 

 

5,453 

 

 

15,322 

 

 

10,334 

Amortization of intangible assets

 

 

1,255 

 

 

1,872 

 

 

2,511 

 

 

3,641 

Total cost and expenses

 

 

23,198 

 

 

23,288 

 

 

43,950 

 

 

42,967 

Operating loss

 

 

(17,119)

 

 

(18,992)

 

 

(33,528)

 

 

(34,801)

Other income, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income from field services agreement

 

 

1,725 

 

 

— 

 

 

3,741 

 

 

— 

Expense from field services agreement

 

 

(1,758)

 

 

— 

 

 

(3,987)

 

 

— 

Unrealized gain on fair value of warrants

 

 

8,697 

 

 

19,017 

 

 

6,877 

 

 

9,317 

Interest expense

 

 

— 

 

 

(3,289)

 

 

— 

 

 

(6,163)

Loss on extinguishment of debt

 

 

— 

 

 

— 

 

 

— 

 

 

(500)

Other income, net

 

 

608 

 

 

342 

 

 

1,293 

 

 

502 

Total income, net

 

 

9,272 

 

 

16,070 

 

 

7,924 

 

 

3,156 

Loss before income taxes

 

 

(7,847)

 

 

(2,922)

 

 

(25,604)

 

 

(31,645)

Income tax expense

 

 

(400)

 

 

(1)

 

 

(1,077)

 

 

(1)

Net loss

 

 

(8,247)

 

 

(2,923)

 

 

(26,681)

 

 

(31,646)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to ordinary shareholders:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(8,247)

 

$

(2,923)

 

$

(26,681)

 

$

(31,646)

Diluted

 

$

(16,944)

 

$

(21,940)

 

$

(33,558)

 

$

(40,963)

Net loss per share attributable to ordinary shareholders:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.15)

 

$

(0.06)

 

$

(0.49)

 

$

(0.69)

Diluted

 

$

(0.30)

 

$

(0.43)

 

$

(0.60)

 

$

(0.81)

Weighted-average shares used in computing net income (loss) per share attributable to ordinary shareholders:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

54,175,731 

 

 

45,829,600 

 

 

54,165,439 

 

 

45,728,793 

Diluted

 

 

55,781,078 

 

 

50,437,716 

 

 

56,262,936 

 

 

50,363,801 

 

STRONGBRIDGE BIOPHARMA plc

Reconciliation of Non-GAAP Financial Measures (unaudited)

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30, 2019

 

    

Operating
loss

    

Loss
before
income
taxes

    

Net loss
attributable
to ordinary
shareholders

    

Net loss
per share
attributable
to ordinary
shareholders

GAAP

 

$

(17,119)

 

$

(7,847)

 

$

(8,247)

 

$

(0.15)

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangible assets (a)

 

$

1,255 

 

$

1,255 

 

$

1,255 

 

 

 

Stock-based compensation - Research & Development (b)

 

$

592 

 

$

592 

 

$

592 

 

 

 

Stock-based compensation - Selling, General & Admin. (b)

 

$

1,981 

 

$

1,981 

 

$

1,981 

 

 

 

Unrealized gain on fair value of warrants (c)

 

 

— 

 

$

(8,697)

 

$

(8,697)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted

 

$

(13,291)

 

$

(12,716)

 

$

(13,116)

 

$

(0.24)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30, 2018

 

    

Operating
loss

    

Loss
before
income
taxes

    

Net loss
attributable
to ordinary
shareholders

    

Net loss per
share
attributable
to ordinary
shareholders

GAAP

 

$

(18,992)

 

$

(2,922)

 

$

(2,923)

 

$

(0.06)

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangible asset (a)

 

$

1,872 

 

$

1,872 

 

$

1,872 

 

 

 

Stock-based compensation - Research & Development (b)

 

$

463 

 

$

463 

 

$

463 

 

 

 

Stock-based compensation - Selling, General & Admin. (b)

 

$

1,521 

 

$

1,521 

 

$

1,521 

 

 

 

Unrealized gain on fair value of warrants (c)

 

 

— 

 

$

(19,017)

 

$

(19,017)

 

 

 

Non-cash interest expense (d)

 

 

— 

 

$

1,430 

 

$

1,430 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted

 

$

(15,136)

 

$

(16,653)

 

$

(16,654)

 

$

(0.36)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2019

 

    

Operating
loss

    

Loss
before
income
taxes

    

Net loss
attributable
to ordinary
shareholders

    

Net loss per
share
attributable
to ordinary
shareholders

GAAP

 

$

(33,528)

 

$

(25,604)

 

$

(26,681)

 

$

(0.49)

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangible assets (a)

 

$

2,511 

 

$

2,511 

 

$

2,511 

 

 

 

Stock-based compensation - Research & Development (b)

 

$

1,104 

 

$

1,104 

 

$

1,104 

 

 

 

Stock-based compensation - Selling, General & Admin. (b)

 

$

3,792 

 

$

3,792 

 

$

3,792 

 

 

 

Unrealized gain on fair value of warrants (c)

 

 

— 

 

$

(6,877)

 

$

(6,877)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted

 

$

(26,121)

 

$

(25,074)

 

$

(26,151)

 

$

(0.48)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2018

 

    

Operating
loss

    

Loss
before
income
taxes

    

Net loss
attributable
to ordinary
shareholders

    

Net loss per
share
attributable
to ordinary
shareholders

GAAP

 

$

(34,801)

 

$

(31,645)

 

$

(31,646)

 

$

(0.69)

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of intangible asset (a)

 

$

3,641 

 

$

3,641 

 

$

3,641 

 

 

 

Stock-based compensation - Research & Development (b)

 

$

871 

 

$

871 

 

$

871 

 

 

 

Stock-based compensation - Selling, General & Admin. (b)

 

$

2,801 

 

$

2,801 

 

$

2,801 

 

 

 

Unrealized gain on fair value of warrants (c)

 

 

— 

 

$

(9,317)

 

$

(9,317)

 

 

 

Non-cash interest and debt extinguishment expense (d)

 

 

— 

 

$

2,662 

 

$

2,662 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted

 

$

(27,488)

 

$

(30,987)

 

$

(30,988)

 

$

(0.68)

The following information was filed by Strongbridge Biopharma Plc (SBBP) on Wednesday, July 31, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Screenshot taken from Lumber Liquidators 10-K Annual Report
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Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
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Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

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FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
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Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
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Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

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Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
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Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

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Financial Ratios
Available Financial Ratios
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