2022 Q3 Form 10-Q Financial Statement

#000155837022011888 Filed on August 03, 2022

View on sec.gov

Income Statement

Concept 2022 Q3 2022 Q2 2022 Q1
Revenue $4.284M $9.066M $1.498M
YoY Change 316.73% 3208.76% 4180.0%
Cost Of Revenue $497.0K $378.0K $230.0K
YoY Change 123.87% 175.91% 5650.0%
Gross Profit $3.787M $8.688M $1.268M
YoY Change 369.85% 6241.61% 3990.32%
Gross Profit Margin 88.4% 95.83% 84.65%
Selling, General & Admin $21.94M $22.33M $21.45M
YoY Change 25.31% 44.38% 47.74%
% of Gross Profit 579.3% 257.0% 1691.56%
Research & Development $21.12M $31.46M $32.51M
YoY Change -23.32% 25.3% 63.28%
% of Gross Profit 557.59% 362.06% 2563.88%
Depreciation & Amortization $442.0K $438.0K $350.0K
YoY Change 40.32% 37.74% 74.13%
% of Gross Profit 11.67% 5.04% 27.6%
Operating Expenses $43.05M $53.78M $53.96M
YoY Change -4.42% 32.57% 56.73%
Operating Profit -$39.27M -$45.10M -$52.69M
YoY Change -11.24% 11.54% 53.18%
Interest Expense $2.144M $95.00K -$73.00K
YoY Change 1453.62% 352.38% -148.67%
% of Operating Profit
Other Income/Expense, Net -$1.594M $95.00K -$73.00K
YoY Change -1255.07% 352.38% -100.07%
Pretax Income -$40.86M -$45.00M -$52.76M
YoY Change -7.35% 11.36% -180.24%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$40.86M -$45.00M -$52.76M
YoY Change 16.39% 27.16% -220.6%
Net Earnings / Revenue -953.8% -496.37% -3522.3%
Basic Earnings Per Share -$0.79 -$0.89 -$1.05
Diluted Earnings Per Share -$0.79 -$0.89 -$1.05
COMMON SHARES
Basic Shares Outstanding 50.72M 50.40M 50.33M
Diluted Shares Outstanding 51.40M 50.40M 50.33M

Balance Sheet

Concept 2022 Q3 2022 Q2 2022 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $347.8M $235.6M $241.0M
YoY Change 5.92% -36.01% -40.47%
Cash & Equivalents $185.1M $113.2M $78.54M
Short-Term Investments $162.7M $122.4M $162.4M
Other Short-Term Assets $10.75M $12.03M $11.62M
YoY Change 47.64% 16.79% 57.07%
Inventory
Prepaid Expenses
Receivables $3.328M $1.707M $862.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $361.9M $249.3M $253.4M
YoY Change 7.82% -34.12% -38.5%
LONG-TERM ASSETS
Property, Plant & Equipment $2.426M $2.559M $2.722M
YoY Change -17.93% -16.13% -9.45%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $15.94M $16.11M $18.68M
YoY Change 46.8% 4812.8% 6128.0%
Total Long-Term Assets $27.74M $28.34M $31.38M
YoY Change 37.42% 185.26% 211.41%
TOTAL ASSETS
Total Short-Term Assets $361.9M $249.3M $253.4M
Total Long-Term Assets $27.74M $28.34M $31.38M
Total Assets $389.6M $277.7M $284.8M
YoY Change 9.5% -28.51% -32.54%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $4.933M $6.012M $12.01M
YoY Change 6.91% 20.02% 31.3%
Accrued Expenses $25.74M $35.61M $25.20M
YoY Change 40.93% 199.71% 252.43%
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 $33.10M $44.57M $47.27M
YoY Change 41.04% 155.28% 180.56%
LONG-TERM LIABILITIES
Long-Term Debt $72.96M $34.27M $0.00
YoY Change
Other Long-Term Liabilities $2.360M $3.204M $1.781M
YoY Change 12.17% 41.9% -25.79%
Total Long-Term Liabilities $75.32M $37.48M $1.781M
YoY Change 3479.9% 1559.74% -25.79%
TOTAL LIABILITIES
Total Short-Term Liabilities $33.10M $44.57M $47.27M
Total Long-Term Liabilities $75.32M $37.48M $1.781M
Total Liabilities $108.4M $82.05M $49.06M
YoY Change 223.06% 123.56% 18.89%
SHAREHOLDERS EQUITY
Retained Earnings -$667.6M -$626.7M -$581.7M
YoY Change 37.34% 38.97% 39.97%
Common Stock $56.00K $50.00K $50.00K
YoY Change 12.0% 0.0% 0.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $281.2M $195.6M $235.8M
YoY Change
Total Liabilities & Shareholders Equity $389.6M $277.7M $284.8M
YoY Change 9.5% -28.51% -32.54%

Cashflow Statement

Concept 2022 Q3 2022 Q2 2022 Q1
OPERATING ACTIVITIES
Net Income -$40.86M -$45.00M -$52.76M
YoY Change 16.39% 27.16% -220.6%
Depreciation, Depletion And Amortization $442.0K $438.0K $350.0K
YoY Change 40.32% 37.74% 74.13%
Cash From Operating Activities -$46.99M -$38.81M -$53.63M
YoY Change 17.0% 21.88% 59.95%
INVESTING ACTIVITIES
Capital Expenditures -$95.00K -$60.00K $127.0K
YoY Change -10.38% -76.0% 958.33%
Acquisitions
YoY Change
Other Investing Activities -$39.60M $36.04M $72.65M
YoY Change -162.97% 161.66% -149.86%
Cash From Investing Activities -$39.70M $35.98M $72.52M
YoY Change -163.23% 166.06% -149.77%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 158.6M 37.50M 399.0K
YoY Change 38293.22% 9820.63% -99.76%
NET CHANGE
Cash From Operating Activities -46.99M -38.81M -53.63M
Cash From Investing Activities -39.70M 35.98M 72.52M
Cash From Financing Activities 158.6M 37.50M 399.0K
Net Change In Cash 71.88M 34.67M 19.29M
YoY Change 212.07% -293.26% -241.23%
FREE CASH FLOW
Cash From Operating Activities -$46.99M -$38.81M -$53.63M
Capital Expenditures -$95.00K -$60.00K $127.0K
Free Cash Flow -$46.89M -$38.75M -$53.76M
YoY Change 17.07% 22.66% 60.27%

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<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 global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases. Rhythm’s precision medicine, IMCIVREE<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">®</sup> (setmelanotide), 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. In the United States, IMCIVREE is approved for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency as determined by U.S. Food and Drug Administration (FDA) approved test demonstrating variants in<i style="font-style:italic;"> POMC</i>, <i style="font-style:italic;">PCSK1</i> or <i style="font-style:italic;">LEPR</i> genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS), or Bardet-Biedl syndrome (BBS).  In the European Union and Great Britain, IMCIVREE is indicated 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. A Type II variation application to the European Medicines Agency seeking regulatory approval and authorization for setmelanotide to treat obesity and control of hunger in adult and pediatric patients 6 years of age and older with BBS also is under review. In July 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to expand the current indication for IMCIVREE to include the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with BBS. The European Commission, which has the authority to grant and expand marketing authorizations for medicinal products in the EU, is anticipated to make a final decision on the application to expand the indication for IMCIVREE in the second half of 2022. In addition, we are advancing a broad clinical development program for setmelanotide in patients with hyperphagia and severe obesity caused by additional rare MC4R pathway diseases to expand the approved indications in the United States and Europe.  In addition to the United States, European Union and United Kingdom, we and our partners are seeking approval for IMCIVREE to treat patients with these MC4R pathway-related obesities in Israel, China, Hong Kong and Macau.</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:#ffffff;">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.  The Company has wholly owned subsidiaries in the United States, Ireland, the United Kingdom, France, Italy, the Netherlands, Germany, Spain and Canada.</span></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:#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;text-align:justify;text-indent:36pt;margin:0pt;">There are many uncertainties regarding the COVID-19 pandemic, and the Company is closely monitoring the impact of the pandemic on all aspects of its business, including how the pandemic may continue to impact its patients, employees, suppliers, vendors, business partners and distribution channels. While the pandemic did not materially affect the Company's financial results and business operations for the three and six months ended June 30, 2022, the Company is unable to predict the impact that COVID-19 will have on its financial position and operating results in future periods </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">due to numerous uncertainties. The Company will continue to assess the evolving impact of the COVID-19 pandemic and will make adjustments to its operations as necessary.</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 June 30, 2022, the Company had an accumulated deficit of $626,704.  The Company has primarily funded these losses through the proceeds from the sales of common and preferred stock, asset sales, royalty financing, out-license arrangements, 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;">At June 30, 2022, the Company had $235,596 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 and cash equivalents and short term investments will be sufficient to fund the Company’s operations into 2024, and that such existing cash and cash equivalents and short term investments, together with the second investment tranche under the Revenue Interest Financing Agreement, or RIFA, entered into with entities managed by HealthCare Royalty Management, LLC expected in the second half of 2022, will be sufficient to fund the Company's operations into at least the second half of 2024.</p>
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Use of Estimates</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 preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. Significant estimates relied upon in preparing these financial statements include estimates related to determining our net product revenue, license revenue, accruals related to research and development expenses, assumptions used to record stock-based compensation expense, interest expense on our deferred royalty obligation, assumptions used to value the embedded derivative in our deferred royalty obligation, assumptions used to value the common stock received from RareStone Group Ltd., or RareStone, and the valuation allowance on the Company's deferred tax assets.  Estimates are periodically reviewed in light of changes in circumstances, facts and experience.  Changes in estimates are recorded in the period in which they become known.  Actual results could differ materially from those estimates.</p>
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