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MacroGenics Provides Update on Corporate Progress, Second Quarter 2024 Financial Results

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MacroGenics (NASDAQ: MGNX) provided an update on its corporate progress and Q2 2024 financial results. Key highlights include:

  • Upcoming poster presentation of TAMARACK Phase 2 mCRPC study data at ESMO in September
  • Receipt of $100 million in milestones from Incyte for ZYNYZ® (retifanlimab-dlwr) advancement
  • Confirmed cash runway guidance into 2026
  • Q2 2024 revenue of $10.8 million, down from $13.1 million in Q2 2023
  • Net loss of $55.7 million for Q2 2024, compared to net income of $57.5 million in Q2 2023
  • Cash position of $140.4 million as of June 30, 2024, not including the $100 million milestone payment

The company continues to advance its proprietary and partnered programs, including vobra duo, lorigerlimab, and MGC028.

MacroGenics (NASDAQ: MGNX) ha fornito un aggiornamento sui suoi progressi aziendali e sui risultati finanziari del secondo trimestre del 2024. I principali punti salienti includono:

  • Presentazione imminente dei dati dello studio TAMARACK di Fase 2 mCRPC all'ESMO di settembre
  • Ricevuti 100 milioni di dollari in traguardi da Incyte per l'avanzamento di ZYNYZ® (retifanlimab-dlwr)
  • Guida confermata per l'orizzonte di cassa fino al 2026
  • Entrate del Q2 2024 di 10,8 milioni di dollari, in calo rispetto ai 13,1 milioni di dollari del Q2 2023
  • Perdita netta di 55,7 milioni di dollari per il Q2 2024, rispetto a un utile netto di 57,5 milioni di dollari nel Q2 2023
  • Posizione di cassa di 140,4 milioni di dollari al 30 giugno 2024, non includendo il pagamento del traguardo di 100 milioni di dollari

L'azienda continua a far progredire i suoi programmi proprietari e in partnership, tra cui vobra duo, lorigerlimab e MGC028.

MacroGenics (NASDAQ: MGNX) proporcionó una actualización sobre su progreso corporativo y los resultados financieros del segundo trimestre de 2024. Los aspectos más destacados incluyen:

  • Próxima presentación de cartel sobre los datos del estudio TAMARACK de Fase 2 mCRPC en ESMO en septiembre
  • Recepción de 100 millones de dólares en hitos de Incyte para el avance de ZYNYZ® (retifanlimab-dlwr)
  • Orientación confirmada de efectivo hasta 2026
  • Ingresos del Q2 2024 de 10,8 millones de dólares, en comparación con los 13,1 millones de dólares del Q2 2023
  • Pérdida neta de 55,7 millones de dólares para el Q2 2024, en comparación con una ganancia neta de 57,5 millones de dólares en el Q2 2023
  • Posición de efectivo de 140,4 millones de dólares al 30 de junio de 2024, sin incluir el pago del hito de 100 millones de dólares

La empresa continúa avanzando en sus programas propios y en asociación, incluidos vobra duo, lorigerlimab y MGC028.

MacroGenics (NASDAQ: MGNX)는 2024년 2분기 재무 결과 및 기업 진행 상황에 대한 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:

  • 9월 ESMO에서 발표될 TAMARACK 2상 mCRPC 연구 데이터 포스터 발표 예정
  • ZYNYZ® (retifanlimab-dlwr) 발전을 위한 Incyte로부터 1억 달러의 마일스톤 수령
  • 2026년까지의 현금 보유 지침 확인
  • 2024년 2분기 수익 1,080만 달러, 2023년 2분기 1,310만 달러에서 감소
  • 2024년 2분기 순손실 5,570만 달러, 2023년 2분기 순이익 5,750만 달러에 비해 감소
  • 2024년 6월 30일 기준 현금 보유액 1억 4,040만 달러, 1억 달러의 마일스톤 지불을 포함하지 않음

회사는 vobra duo, lorigerlimab 및 MGC028을 포함한 자사 및 파트너 프로그램을 계속 발전시키고 있습니다.

MacroGenics (NASDAQ: MGNX) a fourni une mise à jour sur ses progrès d'entreprise et les résultats financiers du deuxième trimestre 2024. Les éléments clés comprennent :

  • Présentation imminente des données de l'étude de Phase 2 mCRPC TAMARACK lors de l'ESMO en septembre
  • Réception de 100 millions de dollars de jalons de la part d'Incyte pour l'avancement de ZYNYZ® (retifanlimab-dlwr)
  • Prévisions de liquidités confirmées jusqu'en 2026
  • Revenus du T2 2024 de 10,8 millions de dollars, en baisse par rapport à 13,1 millions de dollars au T2 2023
  • Perte nette de 55,7 millions de dollars pour le T2 2024, par rapport à un bénéfice net de 57,5 millions de dollars au T2 2023
  • Position de trésorerie de 140,4 millions de dollars au 30 juin 2024, sans inclure le paiement des jalons de 100 millions de dollars

L'entreprise continue de faire avancer ses programmes propriétaires et partenaires, y compris vobra duo, lorigerlimab et MGC028.

MacroGenics (NASDAQ: MGNX) hat ein Update zu seinem Unternehmensfortschritt und den finanziellen Ergebnissen des 2. Quartals 2024 veröffentlicht. Die wichtigsten Highlights umfassen:

  • Bevorstehende Präsentation der Daten der TAMARACK Phase 2 mCRPC-Studie auf der ESMO im September
  • Erhalt von 100 Millionen US-Dollar an Meilensteinen von Incyte für den Fortschritt von ZYNYZ® (retifanlimab-dlwr)
  • Bestätigte Cash-Ressourcen bis 2026
  • Einnahmen im 2. Quartal 2024 von 10,8 Millionen US-Dollar, verglichen mit 13,1 Millionen US-Dollar im 2. Quartal 2023
  • Nettoverlust von 55,7 Millionen US-Dollar für das 2. Quartal 2024, im Vergleich zu einem Nettogewinn von 57,5 Millionen US-Dollar im 2. Quartal 2023
  • Liquidität von 140,4 Millionen US-Dollar zum 30. Juni 2024, ohne die Meilensteinzahlung von 100 Millionen US-Dollar

Das Unternehmen entwickelt weiterhin seine eigenen und Partnerprogramme, darunter vobra duo, lorigerlimab und MGC028.

Positive
  • Received $100 million in milestone payments from Incyte for ZYNYZ® advancement
  • Confirmed cash runway guidance into 2026
  • Upcoming presentation of TAMARACK Phase 2 mCRPC study data at ESMO in September
  • Ongoing enrollment in Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab
  • Anticipates submitting IND application for MGC028 by end of 2024
  • Eligible to receive up to $210 million in remaining development and regulatory milestones from Incyte
  • Receives tiered royalties of 15% to 24% from Incyte on global net sales of retifanlimab
Negative
  • Total revenue decreased to $10.8 million in Q2 2024 from $13.1 million in Q2 2023
  • Net loss of $55.7 million in Q2 2024 compared to net income of $57.5 million in Q2 2023
  • Research and development expenses increased to $51.7 million in Q2 2024 from $43.2 million in Q2 2023
  • Cash position decreased to $140.4 million as of June 30, 2024, from $229.8 million as of December 31, 2023

Insights

MacroGenics' Q2 2024 results reveal a challenging financial position. Revenue decreased to $10.8 million from $13.1 million year-over-year, primarily due to reduced revenue from the Provention Asset Purchase Agreement. The net loss widened to $55.7 million compared to a net income of $57.5 million in Q2 2023, which included a $100 million gain from royalty monetization.

R&D expenses increased by 19.7% to $51.7 million, driven by costs related to MGC028. The cash position declined to $140.4 million from $229.8 million at the end of 2023. However, the subsequent $100 million milestone payment from Incyte significantly bolsters the company's financial outlook, extending the cash runway into 2026.

While the financial results are concerning, the milestone payment and potential future payments from partners provide a lifeline for continued development of key pipeline assets.

MacroGenics' pipeline shows promise, particularly with vobra duo (vobramitamab duocarmazine) in mCRPC. The upcoming ESMO presentation of TAMARACK Phase 2 data is a critical milestone. The study's primary endpoint of 6-month rPFS rate has been reached, with mature efficacy data expected in H2 2024. This could be a potential game-changer in the competitive mCRPC landscape.

The company's diversified B7-H3 directed therapies, including MGC026 and the lorigerlimab program in the LORIKEET study, demonstrate a robust oncology pipeline. The advancement of MGC028, targeting ADAM9, further strengthens their ADC portfolio.

Incyte's positive Phase 3 results for retifanlimab in anal and lung cancer are encouraging, potentially leading to additional milestone payments and royalties. This partnership success validates MacroGenics' technology platform and could attract future collaborations.

MacroGenics' strategy focuses on developing innovative antibody-based therapeutics for cancer treatment. The company's approach of leveraging partnerships while advancing its proprietary pipeline is prudent, balancing risk and potential rewards.

The $100 million milestone from Incyte demonstrates the value of their partnered programs. With potential for up to $540 million in additional milestones plus tiered royalties, this partnership could significantly impact future revenues.

The company's focus on ADCs and bispecific antibodies aligns with current trends in oncology drug development. The diverse pipeline targeting various solid tumors and hematological malignancies provides multiple shots on goal.

However, MacroGenics faces intense competition in the oncology space. The success of vobra duo in mCRPC and other pipeline assets will be important for the company's long-term value proposition. The extended cash runway provides a buffer, but the company needs to deliver clinical success to maintain investor confidence.

  • Upcoming poster presentation of protocol-defined TAMARACK Phase 2 mCRPC study data at ESMO in September
  • Received $100.0 million in milestones related to Incyte’s advancement of ZYNYZ® (retifanlimab-dlwr) subsequent to quarter-end
  • Confirming cash runway guidance into 2026

ROCKVILLE, Md., Aug. 06, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2024.

“We are pleased to have the opportunity to present updated safety and efficacy data from our Phase 2 TAMARACK trial of vobra duo at the upcoming European Society for Medical Oncology (ESMO) Congress in September," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “In addition, we recently solidified our cash position with the receipt of $100.0 million in milestones, following the positive Phase 3 top-line results from Incyte’s registrational studies of retifanlimab in both anal and lung cancer.”

Updates on Proprietary Investigational Programs

Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.

B7-H3-Directed Therapies

  • Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation.
    • The TAMARACK Phase 2 study of vobra duo is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W). MacroGenics completed enrollment of the TAMARACK study in the fourth quarter of 2023, and the study has reached its landmark primary endpoint of 6-month radiographic progression-free survival (rPFS) rate. While mCRPC study participants are no longer being dosed in the study, participants continue to be monitored for adverse events, disease progression and survival.
    • Updated TAMARACK safety and efficacy data, including the study’s primary endpoint, will be presented in a poster session at the ESMO Congress in September 2024. This data will be based on a data cut-off date of July 9, 2024. The abstract submitted to ESMO in May was based on an April 12 data cut off. MacroGenics expects to have the mature efficacy findings, including median rPFS, in the second half of 2024 and plans to present the data at a subsequent medical conference.
    • Following the ESMO poster presentation, the Company plans to host a conference call with investors to discuss the TAMARACK data and potential next steps for vobra duo.
    • MacroGenics continues to enroll a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors. The Company anticipates commencing a dose expansion study of this combination later this year.
  • MGC026 is a clinical B7-H3-targeting ADC that is site-specifically conjugated to exatecan, a topoisomerase I inhibitor payload developed by Synaffix (a Lonza company). With distinct mechanisms of action, vobra duo and MGC026 may address different cancers, tumor stages, or be used in combination with alternate agents — or potentially with one another — to enhance their clinical utility. A Phase 1 dose escalation study of MGC026 in patients with advanced solid tumors is ongoing.

Lorigerlimab

  • Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART® molecule. In addition to the ongoing study of lorigerlimab in combination with vobra duo mentioned above, MacroGenics is enrolling LORIKEET, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current trial design includes a primary study endpoint of rPFS. The Company anticipates completing enrollment of the study in 2024 or early 2025 and providing a clinical update in the first half of 2025.

Emerging ADC Pipeline

  • MGC028 is a preclinical ADC incorporating an ADAM9-targeting antibody and represents the second MacroGenics ADC molecule that incorporates Synaffix’s novel site-specific linker and topoisomerase I inhibitor-based cytotoxic payload. ADAM9 (a disintegrin and metalloprotease domain 9) is a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers, making it an attractive target for cancer treatment. The Company continues to anticipate submitting an investigational new drug (IND) application for MGC028 by the end of 2024 and initiating a Phase 1 clinical study in 2025.

Partnered Programs

  • MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing. MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. Under an October 2022 exclusive option and collaboration agreement, Gilead Sciences, Inc. (Gilead) has the option to license MGD024 at predefined decision points during the Phase 1 study.
  • ZYNYZ® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting PD-1 that the Company licensed to Incyte Corporation (Incyte) in 2017. Incyte recently announced positive Phase 3 top-line results for its registrational studies of retifanlimab in squamous cell carcinoma of the anal canal and non-small cell lung cancer and continues to conduct global studies of retifanlimab across multiple indications.

    Subsequent to June 30, 2024, MacroGenics announced the achievement of $100.0 million in milestones from Incyte related to development progress of retifanlimab, following an agreement on July 24, 2024, pursuant to which certain milestones were deemed to have been met. MacroGenics is further eligible to receive up to a total of $210.0 million in remaining development and regulatory milestones and up to $330.0 million in potential commercial milestones from Incyte. MacroGenics receives tiered royalties of 15% to 24% from Incyte on any global net sales of the product and manufactures a portion of Incyte’s global commercial supply of retifanlimab.

Second Quarter 2024 Financial Results

  • Cash Position: Cash, cash equivalents and marketable securities balance as of June 30, 2024, was $140.4 million, compared to $229.8 million as of December 31, 2023. The June 30, 2024 balance did not include the $100.0 million in milestones subsequently received from Incyte.
  • Revenue: Total revenue was $10.8 million for the quarter ended June 30, 2024, compared to total revenue of $13.1 million for the quarter ended June 30, 2023. The decrease was primarily due to less revenue recognized under the Provention Asset Purchase Agreement and was partially offset by increased revenue from the Company’s collaboration with Gilead and increased contract manufacturing revenue.
  • R&D Expenses: Research and development expenses were $51.7 million for the quarter ended June 30, 2024, compared to $43.2 million for the quarter ended June 30, 2023. The increase was primarily due to manufacturing and IND-enabling costs related to MGC028.
  • SG&A Expenses: Selling, general and administrative expenses were $14.4 million for the quarter ended June 30, 2024, compared to $13.7 million for the quarter ended June 30, 2023.
  • Net Income (Loss): Net loss was $55.7 million for the quarter ended June 30, 2024, compared to net income of $57.5 million for the quarter ended June 30, 2023. Net income for the quarter ended June 30, 2023 included approximately $100.0 million as a component of Other Income related to the sale of the Company’s single-digit royalty interest on global net sales of TZIELD® (teplizumab-mzwv) to DRI Healthcare Acquisitions LP in March 2023.
  • Shares Outstanding: Shares of common stock outstanding as of June 30, 2024 were 62,720,969.
  • Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $140.4 million as of June 30, 2024, plus the $100.0 million in milestones subsequently received from Incyte, in addition to projected and anticipated future payments from partners and product revenues should support its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the Phase 2 LORIKEET study as well as MacroGenics’ other ongoing clinical and preclinical studies.

No Conference Call

Given the embargoed TAMARACK data being presented at the upcoming ESMO presentation, the Company’s management has entered a quiet period and will not be hosting a conference call to discuss its financial results or corporate progress for the quarter ended June 30, 2024. The Company intends to resume its quarterly results conference calls in the future.


MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
 
 June 30, 2024 December 31, 2023
 (unaudited)  
Cash, cash equivalents and marketable securities$140,372  $229,805 
Total assets 201,137   298,418 
Deferred revenue 79,321   80,894 
Total stockholders' equity 57,819   152,613 
        


MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)
(Amounts in thousands, except share and per share data)
 
 Three Months Ended June 30, Six Months Ended June 30,
  2024   2023   2024   2023 
Revenues:       
Collaborative and other agreements$2,065  $6,021  $3,514  $22,708 
Product sales, net 5,248   5,062   10,109   8,552 
Contract manufacturing 2,893   1,587   5,169   5,202 
Royalty revenue 98      258   421 
Government agreements 493   466   851   749 
Total revenues 10,797   13,136   19,901   37,632 
Costs and expenses:       
Cost of product sales 176   258   446   371 
Cost of manufacturing services 2,647   919   4,493   4,329 
Research and development 51,732   43,229   97,760   89,101 
Selling, general and administrative 14,423   13,692   29,133   27,219 
Total costs and expenses 68,978   58,098   131,832   121,020 
Loss from operations (58,181)  (44,962)  (111,931)  (83,388)
Gain on royalty monetization arrangement    100,930      100,930 
Interest and other income 2,523   2,275   5,216   3,348 
Interest and other expense (6)  (774)  (1,139)  (1,430)
Net income (loss) (55,664)  57,469   (107,854)  19,460 
Other comprehensive income (loss):       
Unrealized gain (loss) on investments 11   (80)  (18)  (67)
Comprehensive income (loss)$(55,653) $57,389  $(107,872) $19,393 
        
Net income (loss) per common share:       
Basic$(0.89) $0.93  $(1.73) $0.31 
Diluted$(0.89) $0.92  $(1.73) $0.31 
Weighted average common shares outstanding:       
Basic 62,663,677   61,880,096   62,477,108   61,845,151 
Diluted 62,663,677   62,261,646   62,477,108   62,030,710 
                

About MacroGenics, Inc.

MacroGenics (the Company) is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, MARGENZA and DART are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, including trial design, initiation and enrollment in clinical trials, expected timing of results from clinical trials, discussions with regulatory agencies, commercial prospects of or product revenues from the Company’s products and product candidates, if approved, manufacturing services revenue, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company, as well as future global net sales of TZIELD and the Company’s ability to achieve the milestone payments set forth under the terms of the agreement with DRI (or its successors or assigns with respect to such agreement), the Company’s current cash resources supporting our planned operating expenses and capital requirements into 2026 and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, especially with respect to vobramitamab duocarmazine; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

CONTACTS:
Jim Karrels, Senior Vice President, CFO
1-301-251-5172
info@macrogenics.com


FAQ

What was MacroGenics' revenue for Q2 2024?

MacroGenics reported total revenue of $10.8 million for the second quarter of 2024.

How much did MacroGenics receive in milestone payments from Incyte?

MacroGenics received $100 million in milestone payments from Incyte related to the advancement of ZYNYZ® (retifanlimab-dlwr).

What is MacroGenics' cash runway guidance?

MacroGenics confirmed its cash runway guidance into 2026, based on its current cash position and projected future payments from partners and product revenues.

When will MacroGenics present the TAMARACK Phase 2 study data for vobra duo?

MacroGenics will present updated TAMARACK Phase 2 study data for vobra duo at the ESMO Congress in September 2024.

What was MacroGenics' net income/loss for Q2 2024?

MacroGenics reported a net loss of $55.7 million for the second quarter of 2024.

MacroGenics, Inc.

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