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Organogenesis Reports Fourth Quarter 2023 and Fiscal Year 2023 Financial Results; Introduces Fiscal Year 2024 Guidance

February 29, 2024 | Last Trade: US$4.05 0.03 0.75

CANTON, Mass., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the fourth quarter and the year ended December 31, 2023.

Fourth Quarter 2023 Financial Results Summary:

  • Net revenue of $99.7 million for the fourth quarter of 2023, a decrease of 14% compared to net revenue of $115.5 million for the fourth quarter of 2022. Net revenue for the fourth quarter of 2023 consists of:
    • Net revenue from Advanced Wound Care products of $93.2 million, a decrease of 14% from the fourth quarter of 2022.
    • Net revenue from Surgical & Sports Medicine products of $6.5 million, a decrease of 3% from the fourth quarter of 2022.
  • Net loss of $0.6 million for the fourth quarter of 2023, compared to net income of $7.5 million for the fourth quarter of 2022, a decrease of $8.1 million.
  • Adjusted net income1 of $1.9 million for the fourth quarter of 2023, compared to adjusted net income of $8.9 million for the fourth quarter of 2022, a decrease of $7.0 million.
  • Adjusted EBITDA of $7.5 million for the fourth quarter of 2023, compared to Adjusted EBITDA of $14.1 million for the fourth quarter of 2022, a decrease of $6.6 million.

Fiscal Year 2023 Financial Results Summary:

  • Net revenue of $433.1 million for the year ended December 31, 2023, a decrease of 4% compared to net revenue of $450.9 million for the year ended December 31, 2022. Net revenue for the year ended December 31, 2023 consists of:
    • Net revenue from Advanced Wound Care products of $405.5 million, a decrease of 4% year-over-year.
    • Net revenue from Surgical & Sports Medicine products of $27.6 million, a decrease of 4% year-over-year.
  • Net income of $4.9 million for the year ended December 31, 2023, compared to net income of $15.5 million for the year ended December 31, 2022, a decrease of $10.5 million.
  • Adjusted net income1 of $12.7 million for the year ended December 31, 2023, compared to an adjusted net income of $26.2 million for the year ended December 31, 2022, a decrease of $13.5 million.
  • Adjusted EBITDA of $42.6 million for the year ended December 31, 2023, compared to an adjusted EBITDA of $49.3 million for the year ended December 31, 2022, a decrease of $6.7 million.

“We are building positive momentum with the many commercial support programs implemented to enhance existing customer relationships and regain lost accounts in a uniquely challenging operating environment”, said Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis. "Despite the expected operating environment challenges, we delivered revenues within the lower end of our guidance. Looking ahead to 2024, we expect to return to revenue growth through continued demonstration of value to our customers and new product launches in both our Advanced Wound Care and Surgical & Sports Medicine markets broadening our portfolio of differentiated treatment options.”

Mr. Gillheeney, Sr. continued: “We continue to make progress with the ReNu program, which we believe, represents a significant value driver by addressing a critical unmet need in treating the symptoms of knee osteoarthritis. We remain confident in the long-term opportunity for Organogenesis and expect to continue to lead in our space with highly innovative products that deliver on our mission to provide integrated healing solutions that substantially improve outcomes while lowering the overall cost of care.”

1Defined as GAAP net income adjusted to exclude the effect of amortization, restructuring charges, LCD legal fees and sales retention, write-off of certain assets, facility construction project pause, GPO settlement fee and the resulting income taxes on these items.

Fourth Quarter 2023 Financial Results:

  Three Month Ended December 31,  Change 
  2023  2022  $  % 
  (in thousands, except for
percentages)
       
Advanced Wound Care $93,165  $108,836  $(15,671)  (14%)
Surgical & Sports Medicine  6,486   6,680   (194)  (3%)
Net revenue $99,651  $115,516  $(15,865)  (14%)

Net revenue for the fourth quarter of 2023 was $99.7 million, compared to $115.5 million for the fourth quarter of 2022, a decrease of $15.9 million, or 14%. The decrease in net revenue was driven by a decrease of $15.7 million, or 14% in net revenue of Advanced Wound Care products and a decrease of $0.2 million, or 3% in net revenue of Surgical & Sports Medicine products.

Gross profit for the fourth quarter of 2023 was $71.9 million, or 72% of net revenue, compared to $88.4 million or 77% of net revenue, for the fourth quarter of 2022, a decrease of $16.5 million, or 19%.

Operating expenses for the fourth quarter of 2023 were $73.2 million, compared to $79.7 million for the fourth quarter of 2022, a decrease of $6.5 million, or 8%. R&D expenses were $11.8 million for the fourth quarter of 2023, compared to $11.4 million in the fourth quarter of 2022, an increase of $0.4 million, or 3%. Selling, general and administrative expenses were $61.4 million, compared to $68.3 million in the fourth quarter of 2022, a decrease of $6.9 million, or 10%.

Operating loss for the fourth quarter of 2023 was $1.3 million, compared to operating income of $8.7 million for the fourth quarter of 2022, a decrease of $10.0 million.

Total other expense, net, for the fourth quarter of 2023 was $0.5 million, compared to other income, net of less than $0.1 million for the fourth quarter of 2022, a decrease of approximately $0.6 million.

Net loss for the fourth quarter of 2023 was $0.6 million, or $(0.00) per share, compared to net income of $7.5 million, or $0.06 per share, for the fourth quarter of 2022, a decrease of $8.1 million, or $0.06 per share.

Adjusted net income was $1.9 million for the fourth quarter of 2023, compared to adjusted net income of $8.9 million for the fourth quarter of 2022, a decrease of $7.0 million, or 78%.

Adjusted EBITDA was $7.5 million for the fourth quarter of 2023, compared to $14.1 million for the fourth quarter of 2022, a decrease of $6.6 million, or 47%.

As of December 31, 2023, the Company had $104.3 million in cash, cash equivalents and restricted cash and $66.2 million in term loan debt obligations, compared to $103.3 million in cash, cash equivalents and restricted cash and $70.8 million in term loan debt obligations, as of December 31, 2022.

Fiscal Year 2023 Results

The following table represents net revenue by product grouping for the year ended December 31, 2023 and December 31, 2022, respectively:

  Year Ended December 31,  Change 
  2023  2022  $  % 
  (in thousands, except for
percentages)
       
Advanced Wound Care $405,514  $422,231  $(16,717)  (4%)
Surgical & Sports Medicine  27,626   28,662   (1,036)  (4%)
Net revenue $433,140  $450,893  $(17,753)  (4%)

Net revenue for the year ended December 31, 2023 was $433.1 million, compared to $450.9 million for the year ended December 31, 2022, a decrease of $17.8 million, or 4%. The decrease in net revenue was driven by a decrease of $16.7 million, or 4% in net revenue of Advanced Wound Care products and a decrease of $1.0 million, or 4% in net revenue of Surgical & Sports Medicine products.

Gross profit for the year ended December 31, 2023 is $326.7 million, or 75% of net revenue, compared to $345.9 million, or 77% of net revenue, for the year ended December 31, 2022, a decrease of $19.2 million, or 6%.

Operating expenses for the year ended December 31, 2023 were $314.1 million, compared to $323.6 million for the year ended December 31, 2022, a decrease of $9.4 million, or 3%. R&D expenses were $44.4 million for the year ended December 31, 2023, compared to $39.8 million for year ended December 31, 2022, an increase of $4.6 million, or 12%. Selling, general and administrative expenses were $269.8 million for year ended December 31, 2023, compared to $283.8 million year ended December 31, 2022, a decrease of $14.1 million, or 5%.

Operating income for the year ended December 31, 2023 was $12.5 million, compared to an operating income of $22.3 million for the year ended December 31, 2022, a decrease of $9.8 million.

Total other expense, net, for the year ended December 31, 2023 was $2.1 million, compared to $2.0 million for the year ended December 31, 2022, a decrease of $0.1 million.

Net income of $4.9 million for the year ended December 31, 2023 or $0.04 per share, compared to net income of $15.5 million, or $0.12 per share for the year ended December 31, 2022, a decrease of $10.5 million, or $0.08 per share.

Adjusted net income for the year ended December 31, 2023 was $12.7 million., compared to $26.2 million for the year ended December 31, 2022, a decrease of $13.5 million, or 52%.

Adjusted EBITDA of $42.6 million for the year ended December 31, 2023, compared to Adjusted EBITDA of $49.3 million for the year ended December 31, 2022, a decrease of $6.7 million, or 14%.

Fiscal Year 2024 Guidance:

For the year ending December 31, 2024, the Company expects:

  • Net revenue between $445.0 million and $470.0 million, an increase of approximately 3% to 9% year-over-year, as compared to net revenue of $433.1 million for the year ended December 31, 2023.
    • The 2024 net revenue guidance range assumes:
      • Net revenue from Advanced Wound Care products between $415.0 million and $435.0 million, an increase of approximately 2% to 7% year-over-year as compared to net revenue of $405.5 million for the year ended December 31, 2023.
      • Net revenue from Surgical & Sports Medicine products between $30.0 million and $35.0 million, an increase of approximately 9% to 27% year-over-year as compared to net revenue of $27.6 million for the year ended December 31, 2023.
  • Net income (loss) between ($10.6) million and $4.6 million and adjusted net income (loss) between ($8.1) million and $7.1 million.
  • EBITDA between $5.8 million and $25.0 million and Adjusted EBITDA between $15.8 million and $35.0 million.

Earnings Conference Call:

Financial results for the fourth fiscal quarter and year ended December 31, 2023 will be reported after the market closes on Thursday, February 29th. Management will host a conference call at 5:00 p.m. Eastern Time on February 29th to discuss the results of the quarter, and provide a corporate update with a question and answer session. Those who would like to participate may access the live webcast here, or access the teleconference here. A live webcast of the call will also be provided on the investor relations section of the Company's website at investors.organogenesis.com.

For those unable to participate, the webcast will be archived at investors.organogenesis.com for approximately one year.

ORGANOGENESIS HOLDINGS INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
 
  
  December 31, 
  2023  2022 
Assets      
Current assets:      
Cash and cash equivalents $103,840  $102,478 
Restricted cash  498   812 
Accounts receivable, net  81,999   89,450 
Inventories  28,253   24,783 
Prepaid expenses and other current assets  10,454   5,086 
Total current assets  225,044   222,609 
Property and equipment, net  116,228   102,463 
Intangible assets, net  15,871   20,789 
Goodwill  28,772   28,772 
Operating lease right-of-use assets, net  40,118   43,192 
Deferred tax asset, net  28,002   30,014 
Other assets  5,990   1,520 
Total assets $460,025  $449,359 
       
Liabilities and Stockholders’ Equity      
Current liabilities:      
Current portion of term loan $5,486  $4,538 
Current portion of finance lease obligations  1,081    
Current portion of operating lease obligations - related party  3,140   3,001 
Current portion of operating lease obligations  10,004   8,707 
Accounts payable  30,724   32,330 
Accrued expenses and other current liabilities  30,074   26,447 
Total current liabilities  80,509   75,023 
Term loan, net of current portion  60,745   66,231 
Finance lease obligations, net of current portion  1,888    
Operating lease obligations, net of current portion - related party  17,227   20,367 
Operating lease obligations, net of current portion  19,780   20,947 
Other liabilities  1,213   1,122 
Total liabilities  181,362   183,690 
Commitments and contingencies (Note 18)      
Stockholders’ equity:      
Preferred stock, $0.0001 par value; 1,000,000 shares authorized; none issued      
Common stock, $0.0001 par value; 400,000,000 shares authorized; 132,044,944 and 131,647,677 shares issued; 131,316,396 and 130,919,129 shares outstanding at December 31, 2023 and 2022, respectively.  13   13 
Additional paid-in capital  319,621   310,957 
Accumulated deficit  (40,971)  (45,301)
Total stockholders' equity  278,663   265,669 
Total liabilities and stockholders' equity $460,025  $449,359 

 

ORGANOGENESIS HOLDINGS INC.
UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME

(amounts in thousands, except share and per share data)
 
  
  Three Months Ended December 31,  Year Ended December 31, 
  2023  2022  2023  2022 
Net revenue $99,651  $115,516  $433,140  $450,893 
Cost of goods sold  27,769   27,110   106,481   105,019 
Gross profit  71,882   88,406   326,659   345,874 
Operating expenses:            
Selling, general and administrative  61,381   68,293   269,754   283,808 
Research and development  11,770   11,395   44,380   39,762 
Total operating expenses  73,151   79,688   314,134   323,570 
Loss (income) from operations  (1,269)  8,718   12,525   22,304 
Other expense, net:            
Interest expense, net  (502)  30   (2,190)  (2,009)
Other income (expense), net  (25)  6   57   (13)
Total other expense, net  (527)  36   (2,133)  (2,022)
Net income before income taxes  (1,796)  8,754   10,392   20,282 
Income tax (expense) benefit  1,228   (1,268)  (5,447)  (4,750)
Net (loss) income and comprehensive (loss) income $(568) $7,486  $4,945  $15,532 
Net income, per share:            
Basic $(0.00) $0.06  $0.04  $0.12 
Diluted $(0.00) $0.06  $0.04  $0.12 
Weighted-average common shares outstanding            
Basic  130,916,950   128,661,435   131,231,317   130,070,231 
Diluted  131,857,509   133,348,995   132,746,727   132,383,152 

 

ORGANOGENESIS HOLDINGS INC.
UNAUDITED CONSOLIDATED
STATEMENT OF CASH FLOWS
(amounts in thousands, except share and per share data)
 
  
  Year Ended December 31, 
  2023  2022  2021 
Cash flows from operating activities:         
Net income $4,945  $15,532  $94,202 
Adjustments to reconcile net income to net cash provided by operating activities:         
Depreciation  10,448   5,845   5,781 
Amortization of intangible assets  4,918   4,883   4,949 
Amortization of operating lease right-of-use assets  8,083   7,303   5,946 
Non-cash interest expense  427   434   346 
Deferred interest expense  490   501   1,493 
Deferred tax expense (benefit)  2,012   1,980   (31,976)
Loss on disposal of property and equipment  235   4,482   1,407 
Loss on lease termination  559       
Provision recorded for credit losses  1,297   1,781   2,999 
Adjustment for excess and obsolete inventories  6,580   9,648   12,079 
Stock-based compensation  8,996   6,552   3,864 
Loss on extinguishment of debt        1,883 
Change in fair value of earnout liability        (3,985)
Changes in operating assets and liabilities:         
Accounts receivable  5,539   (8,770)  (28,654)
Inventories  (8,179)  (9,410)  (9,302)
Prepaid expenses and other current and other assets  (10,115)  (378)  (34)
Operating leases  (8,439)  (7,006)  (6,156)
Accounts payable  (108)  3,260   3,847 
Accrued expenses and other current liabilities  3,138   (11,850)  9,354 
Other liabilities  91   72   (6,065)
Net cash provided by operating activities  30,917   24,859   61,978 
Cash flows from investing activities:         
Purchases of property and equipment  (24,364)  (33,898)  (31,220)
Net cash used in investing activities  (24,364)  (33,898)  (31,220)
Cash flows from financing activities:         
Line of credit repayments under the 2019 Credit Agreement        (10,000)
Term loan repayments under the 2019 Credit Agreement        (60,000)
Proceeds from term loan under the 2021 Credit Agreement, net of debt discount and issuance cost        73,174 
Term loan repayments under the 2021 Credit Agreement  (4,688)  (2,813)  (938)
Principal repayments of finance lease obligations  (485)  (200)  (2,630)
Proceeds from the exercise of stock options     2,070   2,198 
Payments of withholding taxes in connection with RSUs vesting  (332)  (648)  (737)
Payments of deferred acquisition consideration     (608)  (483)
Payment to extinguish debt        (1,620)
Net cash used in financing activities  (5,505)  (2,199)  (1,036)
Change in cash, cash equivalents and restricted cash  1,048   (11,238)  29,722 
Cash, cash equivalents, and restricted cash, beginning of year  103,290   114,528   84,806 
Cash, cash equivalents, and restricted cash, end of year $104,338  $103,290  $114,528 
Supplemental disclosure of cash flow information:         
Cash paid for interest $5,436  $2,649  $5,787 
Cash paid for income taxes $3,052  $1,201  $607 
Supplemental disclosure of non-cash investing and financing activities:         
Cumulative effect adjustment for adoption of ASU No. 2016-13 (Note 2) $615  $  $ 
Deferred acquisition consideration and earnout liability recorded for business acquisition $  $828  $ 
Purchases of property and equipment in accounts payable and accrued expenses $841  $1,928  $3,750 
Right-of-use assets obtained through operating lease obligations $5,869  $1,350  $53,793 
Right-of-use assets obtained through finance lease obligations $3,454  $  $ 

Non-GAAP Financial Measures

Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA and adjusted net income to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA and adjusted net income help identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA and adjusted net income provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making.

The following table presents a reconciliation of GAAP net income to non-GAAP EBITDA and non-GAAP Adjusted EBITDA, for each of the periods presented:

  Three Months Ended December 31,  Year Ended December 31, 
($, in thousands) 2023  2022  2023  2022 
Net (loss) income $(568) $7,486  $4,945  $15,532 
Interest expense, net  502   (30)  2,190   2,009 
Income tax expense (benefit)  (1,228)  1,268   5,447   4,750 
Depreciation  2,982   1,514   10,448   5,845 
Amortization  1,229   1,221   4,918   4,883 
EBITDA  2,917   11,459   27,948   33,019 
Stock-based compensation expense  2,366   1,855   8,996   6,552 
Restructuring charge (1)  1,918   750   3,796   2,268 
Write-off of certain assets (2)           4,200 
Settlement fee (3)           2,600 
Facility construction project pause (4)           632 
Legal fees (5)        1,182    
Sales retention (6)  272      694    
Adjusted EBITDA $7,473  $14,064  $42,616  $49,271 

(1) Amounts reflect employee retention and benefits as well as other exit costs associated with the Company’s restructuring activities.

(2) Amount reflects the disposal of certain equipment related to the same facility.

(3) Amounts reflect the fee the Company paid to a GPO to settle previously disputed GPO fees.

(4) Amount reflects the cancellation fees incurred in connection with the Company’s decision to pause one of its manufacturing facility construction projects.

(5) Amount represents the legal fees incurred related to the recently published and withdrawn local coverage determinations, or LCDs.

(6) Amount represents the compensation expenses related to retention for those sales employees impacted by the LCDs.

The following table presents a reconciliation of GAAP net income to non-GAAP adjusted net income, for each of the periods presented:

  Three Months Ended December 31,  Year Ended December 31, 
($, in thousands) 2023  2022  2023  2022 
Net (loss) income $(568) $7,486  $4,945  $15,532 
Amortization  1,229   1,221   4,918   4,883 
Restructuring charge (1)  1,918   750   3,796   2,268 
Write-off of certain assets (2)           4,200 
Settlement fee (3)           2,600 
Facility construction project pause (4)           632 
Legal fees (5)        1,182    
Sales retention (6)  272      694    
Tax on above  (923)  (527)  (2,859)  (3,898)
Adjusted net income $1,928  $8,930  $12,676  $26,217 

(1) Amounts reflect employee retention and benefits as well as other exit costs associated with the Company’s restructuring activities.

(2) Amount reflects the disposal of certain equipment related to the same facility.

(3) Amounts reflect the fee the Company paid to a GPO to settle previously disputed GPO fees.

(4) Amount reflects the cancellation fees incurred in connection with the Company’s decision to pause one of its manufacturing facility construction projects.

(5) Amount represents the legal fees incurred related to the recently published and withdrawn local coverage determinations, or LCDs.

(6) Amount represents the compensation expenses related to retention for those sales employees impacted by the LCDs.

The following table presents a reconciliation of projected GAAP net income (loss) to projected non-GAAP EBITDA and projected non-GAAP Adjusted EBITDA included in our guidance for the year ending December 31, 2024:

  Year Ended December 31, 
($, in thousands) 2024L  2024H 
Net (loss) income $(10,565) $4,616 
Interest expense, net  3,000   2,200 
Income tax expense (benefit)  308   5,061 
Depreciation  9,680   9,680 
Amortization  3,400   3,400 
EBITDA  5,823   24,957 
Stock-based compensation expense  10,000   10,000 
Restructuring charge  -   - 
Adjusted EBITDA  15,823   34,957 

The following table presents a reconciliation of projected GAAP net income (loss) to projected non-GAAP adjusted net income included in our guidance for the year ending December 31, 2024:

  Year Ended December 31, 
($, in thousands) 2024L  2024H 
Net (loss) income $(10,565) $4,616 
Amortization  3,400   3,400 
Restructuring charge      
Tax on above  (918)  (918)
Adjusted net (loss) income $(8,083) $7,098 

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the Company’s expected revenue, net income, adjusted net income, EBITDA, and Adjusted EBITDA for fiscal 2024 and the breakdown of expected revenue in both its Advanced Wound Care and Surgical & Sports Medicine categories. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company’s products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred losses in prior years and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) any resurgence of the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; (11) the impact of the suspension of commercialization of: (a) ReNu and NuCel in connection with the expiration of the FDA’s enforcement grace period for HCT/Ps on May 31, 2021 and (b) Dermagraft in the second quarter of 2022 pending transition of manufacturing to a new manufacturing facility or a third-party manufacturer; and (12) other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2023 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

About Organogenesis Holdings Inc.

Organogenesis Holdings Inc. is a leading regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’s comprehensive portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

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