2021 Q4 Form 10-Q Financial Statement

#000155837021014043 Filed on November 02, 2021

View on sec.gov

Income Statement

Concept 2021 Q4 2021 Q3 2020 Q3
Revenue $1.817M $1.028M $0.00
YoY Change
Cost Of Revenue $236.0K $222.0K
YoY Change
Gross Profit $1.581M $806.0K
YoY Change
Gross Profit Margin 87.01% 78.4%
Selling, General & Admin $21.00M $17.51M $11.29M
YoY Change 60.03% 55.08% 7.16%
% of Gross Profit 1328.02% 2172.08%
Research & Development $31.57M $27.54M $23.00M
YoY Change 43.85% 19.76% -13.46%
% of Gross Profit 1997.09% 3416.75%
Depreciation & Amortization $325.0K $315.0K $170.0K
YoY Change 80.56% 85.29% -10.53%
% of Gross Profit 20.56% 39.08%
Operating Expenses $52.57M $45.05M $34.28M
YoY Change 49.9% 31.39% -7.61%
Operating Profit -$50.99M -$44.24M -$34.28M
YoY Change 29.04% -7.61%
Interest Expense $134.0K $138.0K $470.0K
YoY Change -25.56% -70.64% -57.27%
% of Operating Profit
Other Income/Expense, Net $0.00 $138.0K $466.0K
YoY Change -70.39% -57.79%
Pretax Income -$50.86M -$44.10M -$33.82M
YoY Change 45.72% 30.4% -6.06%
Income Tax -$7.989M -$8.995M
% Of Pretax Income
Net Earnings -$42.87M -$35.11M -$33.82M
YoY Change 22.83% 3.81% -6.07%
Net Earnings / Revenue -2359.16% -3415.08%
Basic Earnings Per Share -$0.70
Diluted Earnings Per Share -$852.6K -$698.7K -$766.2K
COMMON SHARES
Basic Shares Outstanding 50.27M 50.23M 44.12M
Diluted Shares Outstanding 50.25M

Balance Sheet

Concept 2021 Q4 2021 Q3 2020 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $294.9M $328.4M $201.8M
YoY Change 70.63% 62.71% 24.26%
Cash & Equivalents $59.25M $92.37M $67.67M
Short-Term Investments $235.6M $236.0M $134.1M
Other Short-Term Assets $4.103M $7.282M $8.100M
YoY Change 34.61% -10.1% -3.57%
Inventory $111.0K
Prepaid Expenses
Receivables $1.025M
Other Receivables $0.00
Total Short-Term Assets $308.4M $335.6M $209.9M
YoY Change 69.75% 59.89% 22.83%
LONG-TERM ASSETS
Property, Plant & Equipment $2.813M $2.956M $3.289M
YoY Change -11.96% -10.12% -45.18%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $12.14M $10.86M $400.0K
YoY Change 2935.75% 2615.25% -42.86%
Total Long-Term Assets $21.14M $20.19M $5.563M
YoY Change 291.05% 262.88% -15.71%
TOTAL ASSETS
Total Short-Term Assets $308.4M $335.6M $209.9M
Total Long-Term Assets $21.14M $20.19M $5.563M
Total Assets $329.5M $355.8M $215.5M
YoY Change 76.15% 65.13% 21.4%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $5.737M $4.614M $3.793M
YoY Change 17.08% 21.65% -50.74%
Accrued Expenses $30.08M $18.27M $11.54M
YoY Change 139.54% 58.33% -34.08%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $43.43M $23.47M $15.85M
YoY Change 141.34% 48.08% -37.11%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $1.945M $2.104M $2.700M
YoY Change -25.19% -22.07% -15.63%
Total Long-Term Liabilities $1.945M $2.104M $2.700M
YoY Change -25.19% -22.07% -15.63%
TOTAL LIABILITIES
Total Short-Term Liabilities $43.43M $23.47M $15.85M
Total Long-Term Liabilities $1.945M $2.104M $2.700M
Total Liabilities $45.37M $33.56M $18.54M
YoY Change 120.84% 81.01% -34.72%
SHAREHOLDERS EQUITY
Retained Earnings -$528.9M -$486.1M -$424.4M
YoY Change 15.16% 14.52%
Common Stock $50.00K $50.00K $44.00K
YoY Change 13.64% 13.64%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $284.2M $322.3M $196.9M
YoY Change
Total Liabilities & Shareholders Equity $329.5M $355.8M $215.5M
YoY Change 76.15% 65.13% 21.4%

Cashflow Statement

Concept 2021 Q4 2021 Q3 2020 Q3
OPERATING ACTIVITIES
Net Income -$42.87M -$35.11M -$33.82M
YoY Change 22.83% 3.81% -6.07%
Depreciation, Depletion And Amortization $325.0K $315.0K $170.0K
YoY Change 80.56% 85.29% -10.53%
Cash From Operating Activities -$40.47M -$40.16M -$27.03M
YoY Change 38.98% 48.58% -19.58%
INVESTING ACTIVITIES
Capital Expenditures -$68.00K -$106.0K -$130.0K
YoY Change -15.0% -18.46% -50.0%
Acquisitions
YoY Change
Other Investing Activities $7.316M $62.89M $35.04M
YoY Change -88.2% 79.47% -16.03%
Cash From Investing Activities $7.248M $62.78M $34.91M
YoY Change -88.29% 79.83% -15.82%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 100.0K 413.0K 700.0K
YoY Change -76.19% -41.0% 0.0%
NET CHANGE
Cash From Operating Activities -40.47M -40.16M -27.03M
Cash From Investing Activities 7.248M 62.78M 34.91M
Cash From Financing Activities 100.0K 413.0K 700.0K
Net Change In Cash -33.12M 23.03M 8.580M
YoY Change -199.8% 168.45% 0.23%
FREE CASH FLOW
Cash From Operating Activities -$40.47M -$40.16M -$27.03M
Capital Expenditures -$68.00K -$106.0K -$130.0K
Free Cash Flow -$40.40M -$40.05M -$26.90M
YoY Change 39.13% 48.9% -19.34%

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">Rhythm Pharmaceuticals, Inc.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:12pt;margin-left:0pt;margin-top:0pt;overflow:hidden;position:relative;"><span style="padding-bottom:2.0pt;padding-right:2.0pt;position:relative;text-indent:0pt;z-index:1;background:white;"><span style="display:inline-block;width:20.86%;"> </span><b style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:bold;text-align:left;">Notes to Unaudited Condensed Consolidated Financial Statements</b></span><span style="display:block;height:1px;position:absolute;width:100%;z-index:0;">‌</span><span style="float:right;padding-left:2.0pt;position:relative;text-indent:0pt;z-index:1;background:white;"/></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;white-space:pre-wrap;"> (In thousands, except share and per share information)</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">1. Nature of Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">Rhythm Pharmaceuticals, Inc. (the “Company” or “we”) is a commercial-stage biopharmaceutical company focused on changing the paradigm for the treatment of rare genetic diseases of obesity, which are characterized by early-onset, severe obesity and an insatiable hunger or hyperphagia.  Our lead product candidate is IMCIVREE<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">®</sup> (setmelanotide), a potent melanocortin-4 receptor, or MC4R, agonist for the treatment of rare genetic diseases of obesity. We believe IMCIVREE, for which we have exclusive worldwide rights, has the potential to restore dysfunctional MC4R signaling due to impaired MC4R pathway function. MC4R pathway deficiencies result in the disruption of satiety signals and energy homeostasis in the body, which, in turn, leads to intense feelings of hunger and to obesity. IMCIVREE has been approved by the U.S. Food and Drug Administration, or FDA, for chronic weight management in adult and pediatric patients six years of age and older with obesity due to proopiomelanocortin, or POMC, proprotein convertase subtilisin/kexin type 1, or PCSK1, or leptin receptor, or LEPR, deficiency confirmed by genetic testing.  IMCIVREE also has been approved by the European Commission  for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. IMCIVREE is now commercially available in the United States, and we are pursuing an international strategy to establish access and reimbursement for IMCIVREE in the European Union, or EU, and Great Britain.  We also have completed and submitted a supplemental New Drug Application, or sNDA, to the U.S. Food and Drug Administration or FDA, and a Type II variation marketing authorization application, or MAA, to the EMA for IMCIVREE for the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with Bardet-Biedl syndrome, or BBS, or Alström syndrome.  </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">The Company is a Delaware corporation organized in February 2013 under the name Rhythm Metabolic, Inc., and as of October 2015, under the name Rhythm Pharmaceuticals, Inc. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">The Company’s continued development efforts are focused on obesity related to several single gene-related, or monogenic, MC4R pathway deficiencies: Bardet-Biedl and Alstrom syndromes; obesity due to a genetic variant in one of the two alleles of the POMC, PCSK1 or LEPR gene, or heterozygous POMC, PCSK1 or LEPR obesity (collectively HETs); obesity due to steroid receptor coactivator 1, or SRC1, deficiency; obesity due to SH2B adapter protein 1, or SH2B1, deficiency; hypothalamic obesity; and MC4R deficiency obesity.  In addition, we have expanded our development program to explore setmelotide’s potential efficacy in patients with severe obesity which may be due to variants in an additional 31 genes that are related to the MC4R pathway.  There are additional diseases being studied as part of investigator-initiated protocols. Currently, there are no effective or approved treatments for these MC4R pathway-related diseases. The Company believes that the MC4R pathway is a compelling target for treating these genetic diseases because of its critical role in regulating appetite and weight by promoting satiety and weight control, and that peptide therapeutics are uniquely suited for activating this target. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;"> <span style="background-color:#ffffff;">The Company is subject to risks and uncertainties common to commercial-stage companies in the biotechnology industry, including but not limited to risks associated with the commercialization of approved products, completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Commercialization of approved products will require significant resources and in order to market IMCIVREE, the Company must continue to build its sales, marketing, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Liquidity</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">The Company has incurred operating losses and negative cash flows from operations since inception.  As of September 30, 2021, the Company had an accumulated deficit of $486,073.  The Company has primarily funded these losses through the proceeds from the sales of common and preferred stock, asset sales as well as capital contributions received from the former parent company, Rhythm Holdings LLC. To date, the Company has minimal product revenue and management expects operating losses to continue for the foreseeable future. The Company has devoted substantially all of its resources to its drug development efforts, comprising of research and development, manufacturing, conducting clinical trials for its product candidates, protecting its intellectual property, pre-commercialization activities and general and administrative functions relating to these operations. The future success of the Company is dependent on its ability to develop its product candidates and ultimately upon its ability to attain profitable operations.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">In February 2021, the Company completed the sale of a Rare Pediatric Disease Priority Review Voucher, or PRV, that it received in connection with the approval of IMCIVREE for $100,000. As the PRV did not have a carrying value, the gain recognized within Other income (loss) was equal to the gross proceeds received, with costs related to the sale of the voucher recorded within selling, general and administrative expenses. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">At September 30, 2021, the Company had $328,354 of cash and cash equivalents and short-term investments on hand.  In the future, the Company will be dependent on obtaining funding from third parties, such as proceeds from the issuance of debt, sale of equity, product sales and funded research and development programs to maintain the Company's operations and meet the Company's obligations. There is no guarantee that additional equity or other financings will be available to the Company on acceptable terms, or at all. If the Company fails to obtain additional funding when needed, the Company would be forced to scale back, terminate its operations or seek to merge with or be acquired by another company. Management believes that the Company's existing cash resources will be sufficient to fund the Company's operations into at least the second half of 2023.</p>
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