Lexicon Pharmaceuticals to Host Second Quarter 2021 Financial Results Conference Call and Webcast on July 30, 2021

On July 29, 2021 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that it will release its second quarter 2021 financial results on Friday, July 30, 2021 before the markets open. Management will conduct a conference call and live webcast at 8:00 a.m. ET (7:00 a.m. CT) that day to discuss the financial results and to provide a business update (Press release, Lexicon Pharmaceuticals, JUL 29, 2021, View Source [SID1234585300]).

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The dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.

Evelo Biosciences Reports Second Quarter 2021 Financial Results and Business Highlights

On July 29, 2021 Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, reported financial results and business highlights for the second quarter 2021 (Press release, Evelo Biosciences, JUL 29, 2021, View Source [SID1234585357]).

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"We have demonstrated in multiple cohorts in a Phase 1b clinical trial the potential of our platform to create medicines that control systemic inflammation and immunity that are well-tolerated and easily administered. Over the next 6-12 months, we have a series of catalysts that will bring us closer to our mission of delivering on this promise to patients, beginning with data from our EDP1815 Phase 2 trial in psoriasis and the start of our EDP1815 Phase 2 trial in atopic dermatitis, both expected in 3Q 2021," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "Importantly, our efforts with EDP1815 and dermatological diseases are only the beginning. Consistent with our strategy and understanding of the breadth of our platform, we continue to explore ways to enhance and extend the applications of SINTAX-based medicines. We are progressing our next-generation extracellular vesicle (EV) candidates into the clinic next year. And, as we look ahead to later-stage development, we strengthened our team with the addition of Mark Plinio as Chief Commercial Officer. We have the resources and leadership in place to advance and expand our broad portfolio of product candidates that have the potential to be safe, well-tolerated, and affordable therapies for hundreds of millions of people around the world."

Second Quarter 2021 Highlights and Recent Progress

EDP1815 Phase 2 Trial in Atopic Dermatitis

Evelo announced that it has finalized the design of the EDP1815 Phase 2 clinical trial in atopic dermatitis.
The trial will be a 12-week, double-blind, placebo-controlled, multiple cohort trial in patients with mild, moderate, and severe atopic dermatitis.
Approximately 198 patients will be randomized to receive EDP1815, and 66 patients will be randomized to receive placebo. Patients will receive either 1 capsule once daily, 2 capsules once daily, or 1 capsule twice daily.
The primary endpoint will be the mean difference between EDP1815 and placebo in the percentage change from baseline in Eczema Area and Severity Index (EASI) score at week 12.
Secondary endpoints will include a number of physician-reported outcomes, such as Investigators Global Assessment (IGA), Body Surface Area (BSA), along with numerous patient-reported outcomes, such as Dermatology Life Quality Index (DLQI), itch using the daily peak pruritus numerical rating scale, and Patient Oriented Eczema Measure (POEM).
All trial participants who complete the 12-week trial will be eligible to enroll into an open-label extension trial where they will receive EDP1815.
EDP2939 in Inflammatory Diseases

In May 2021, Evelo presented preclinical data for its extracellular vesicle (EV) product candidate, EDP2939, for the treatment of inflammatory diseases, at Virtual IMMUNOLOGY2021, the 104th Annual Meeting of the American Association of Immunologists (AAI).
In the preclinical study, mice undergoing a delayed-type hypersensitivity (DTH) reaction against keyhole limpet hemagglutinin (KLH) were treated with EDP2939, EDP2939 in combination with different antibodies, or with placebo.
These data suggest that EDP2939 requires the stimulation of both the TLR2 receptor and the IL-10 receptor, in addition to lymphocyte homing to the intestinal lymphoid tissue.
Also, in-vitro, EDP2939 induces TLR2-dependent release of IL-10. Fluorescent biodistribution analysis showed that EDP2939 was not detected outside the gastrointestinal tract.
The data suggest that treatment with EDP2939 resulted in broad-based resolution of inflammation and the establishment of immune homeostasis, with no apparent adverse safety or tolerability effects preclinically, providing key insights into the pharmacologic effects, mechanism of action, and biodistribution of EDP2939.
Business Highlights

In June 2021, Evelo announced the appointment of Mark Plinio as Chief Commercial Officer and a member of the Evelo Leadership Team.
Upcoming Key Milestones
EDP1815 – Psoriasis; data anticipated to be reported in 3Q 2021

Data from Phase 2b dose-ranging trial
Data from Phase 1b cohorts with tablets and capsules
EDP1815 – Atopic Dermatitis

Start of Phase 2 trial in 3Q 2021
Data from Phase 2 trial anticipated in 3Q 2022
EDP1867 – Atopic Dermatitis

Interim data from Phase 1b trial anticipated in 4Q 2021
EDP2939 – Inflammation

Initiation of clinical development in 2022
EDP1908 – Oncology

Initiation of clinical development in 2022
Second Quarter 2021 Financial Results

Cash Position: As of June 30, 2021, cash and cash equivalents were $123.3 million, as compared to cash and cash equivalents of $68.9 million as of December 31, 2020.
Research and Development Expenses: R&D expenses were $20.7 million for the three months ended June 30, 2021, compared to $15.2 million for the three months ended June 30, 2020. The $5.5 million increase was primarily due to increased costs related to Evelo’s inflammation clinical development programs, personnel and R&D platform costs, partially offset by decrease in oncology program costs.
General and Administrative Expenses: G&A expenses were $7.0 million for the three months ended June 30, 2021, compared to $5.1 million for the three months ended June 30, 2020. The $1.9 million increase was primarily due to increased personnel, facility, and other costs.
Net Loss: Net loss was $31.6 million for the three months ended June 30, 2021, or $0.59 per basic and diluted share, as compared to a net loss of $20.7 million for the three months ended June 30, 2020, or $0.63 per basic and diluted share.
Conference Call
Evelo will host a conference call and webcast at 8:30 a.m. ET today. To access the call please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 1658301. A live webcast of the event will also be available under "News and Events" in the Investors section of Evelo’s website at View Source The archived webcast will be available on Evelo’s website approximately two hours after the completion of the event and will be available for 30 days following the call.

GlycoMimetics to Report Second Quarter Financial Results on August 5, 2021

On July 29, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that it will host a conference call and webcast to report its second quarter financial results on Thursday, August 5, 2021, at 8:30 a.m. ET (Press release, GlycoMimetics, JUL 29, 2021, View Source [SID1234585373]).

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The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 9977599. Participants are encouraged to connect 15 minutes in advance of the call to ensure they are able to connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, with participant code 9977599.

Labcorp Announces 2021 Second Quarter Results

On July 29, 2021 Labcorp (NYSE: LH), a leading life sciences company, reported results for the second quarter ended June 30, 2021, and raised full-year guidance (Press release, LabCorp, JUL 29, 2021, View Source [SID1234585389]).

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"Our strategy focusing on science, innovation and technology led to strong second quarter results as we continued to advance health care and patient experiences," said Labcorp Chairman and CEO Adam Schechter. "Patients and pharmaceutical clients accelerated their return to normal health care and business activities, which drove 46% revenue growth in our base business. In light of our second quarter performance and improved outlook, we are raising full-year financial guidance."

Labcorp continues to further scientific advancements and make progress on its five-pillar strategy. As an example, in July the company signed an agreement to acquire the outreach laboratory business of Minnesota-based North Memorial Health and provide management services to its inpatient lab. Additionally, the company made significant strides in oncology, introducing capabilities that bring together its leading diagnostic testing and comprehensive drug development services. By doing so, Labcorp can deliver targeted solutions by leveraging breakthrough science and insights from clinical data to aid better treatment decisions and improved patient outcomes. The company also acquired the remaining ownership interest in OmniSeq, a pioneer in solid tumor profiling, after the quarter ended. This addition enhances Labcorp’s growing portfolio of diagnostic tests and clinical trial opportunities for people with cancer.

Separately, the company continued its critical contributions to the ongoing pandemic response, working with state and federal governments to expand testing access and facilitate vaccinations, and supporting the development of COVID-19 vaccines and therapies. To date, the company has performed over 50 million COVID-19 tests.

Consolidated Results

Second Quarter Results

Revenue for the quarter was $3.84 billion, an increase of 38.7% over $2.77 billion in the second quarter of 2020. The increase was due to organic Base Business growth of 35.5%, acquisitions of 1.2%, and favorable foreign currency translation of 2.0%. COVID-19 PCR and antibody testing (COVID-19 Testing) revenue of $444.0 million was flat compared to last year. Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $704.1 million, or 18.3% of revenue, compared to $297.7 million, or 10.8%, in the second quarter of 2020. The company recorded amortization, restructuring charges, and special items, which together totaled $135.8 million in the quarter, compared to $83.0 million during the same period in 2020. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $839.9 million, or 21.9% of revenue, compared to $380.7 million, or 13.8%, in the second quarter of 2020. The increase in operating income and margin was primarily due to organic Base Business growth, acquisitions, and LaunchPad savings, partially offset by higher personnel costs.

Net earnings for the quarter were $467.4 million, compared to $231.6 million in the second quarter of 2020. Diluted EPS were $4.76 in the quarter, up from $2.37 in the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $6.13 in the quarter, up from $2.57 in the second quarter of 2020.

Operating cash flow for the quarter was $487.2 million, compared to $370.7 million in the second quarter of 2020. The increase in operating cash flow was due to favorable working capital, partially offset by lower cash earnings. Capital expenditures totaled $97.2 million, compared to $98.5 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $390.0 million, up from $272.2 million in the second quarter of 2020.

At the end of the quarter, the company’s cash balance and total debt were $2.0 billion and $5.4 billion, respectively. During the quarter, the company repurchased $300.0 million of stock representing approximately 1.1 million shares.

Year-To-Date Results

Revenue was $8.00 billion, an increase of 43.1% from $5.59 billion in the first half of 2020. The increase was due to organic growth of 40.3%, acquisitions of 1.1%, and favorable foreign currency translation of 1.7%. The organic revenue increase includes a 23.8% contribution from the company’s organic Base Business and a 16.6% increase in COVID-19 Testing.

Operating income was $1,762.0 million, or 22.0% of revenue, compared to $105.1 million, or 1.9%, in the first half of 2020. The company recorded amortization, restructuring charges, special items, and impairments, which together totaled $259.8 million in the first half of 2021, compared to $641.5 million during the same period in 2020. This decrease was primarily due to the goodwill impairment recorded in the first quarter of 2020. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) was $2,021.8 million, or 25.3% of revenue, compared to $746.6 million, or 13.3%, in the first half of 2020. The increase in operating income and margin was primarily due to organic Base Business growth, acquisitions, and LaunchPad savings, partially offset by higher personnel costs.

Net earnings (losses) in the first half of 2021 were $1,237.0 million, compared to ($85.6) million in the first half of 2020. Diluted EPS were $12.58 in the first half of 2021 compared to ($0.88) in the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $14.92 in the first half of 2021 compared to $4.94 in the first half of 2020.

Operating cash flow was $1,644.8 million, compared to $574.5 million in the first half of 2020. The increase in operating cash flow was due to higher cash earnings and favorable working capital. Capital expenditures totaled $192.6 million, compared to $205.1 million during the same period in 2020. As a result, free cash flow (operating cash flow less capital expenditures) was $1,452.2 million, up from $369.4 million in the first half of 2020.

Second Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics

Revenue for the quarter was $2.37 billion, an increase of 39.7% over $1.69 billion in the second quarter of 2020. The increase was due to organic Base Business growth of 37.8%, acquisitions of 1.1%, and favorable foreign currency translation of 0.9%. COVID-19 Testing revenue of $444.0 million was flat versus last year.

Total volume (measured by requisitions) increased by 39.6% as organic volume increased by 38.7% and acquisition volume contributed 0.9%. The organic volume growth was due to a 39.4% increase in Base Business, partially offset by a (0.7%) decrease in COVID-19 Testing. Price / mix increased by 0.1% due to currency of 0.9%, COVID-19 Testing of 0.7%, and acquisitions of 0.2%, partially offset by organic Base Business of (1.7%) due to the volume recovery. Organic Base Business volume was up 48.2% while price was up 3.1%.

Adjusted operating income for the quarter was $663.2 million, or 28.0% of revenue, compared to $308.8 million, or 18.2%, in the second quarter of 2020. The increase in adjusted operating income and adjusted operating margin was primarily due to organic Base Business growth and LaunchPad savings, partially offset by higher personnel costs. The company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Drug Development

Revenue for the quarter was $1.50 billion, an increase of 36.7% over $1.09 billion in the second quarter of 2020. The increase was due to organic Base Business growth of 32.1%, acquisitions of 1.3%, and favorable foreign currency translation of 3.7%, partially offset by lower COVID-19 Testing performed through its Central Laboratories business of (0.3%). Drug Development’s Base Business benefited from broad-based demand, including COVID-19 vaccine and therapeutic work.

Adjusted operating income for the quarter was $221.1 million, or 14.8% of revenue, compared to $112.7 million, or 10.3%, in the second quarter of 2020. The increase in adjusted operating income and adjusted operating margin was primarily due to organic Base Business growth and LaunchPad savings, partially offset by higher personnel costs. The company continues to develop and execute LaunchPad programs to support profitable growth in Drug Development.

Net orders and net book-to-bill during the trailing twelve months were $7.86 billion and 1.41, respectively. Backlog at the end of the quarter was $14.28 billion, compared to $13.97 billion last quarter, and the company expects approximately $4.87 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2021

Labcorp is raising 2021 full year guidance to reflect its strong second quarter performance and improved full year outlook. The following guidance assumes foreign exchange rates effective as of June 30, 2021 for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions and share repurchases.

(1) 2021 Updated Guidance includes a benefit from foreign currency translation of 1.0%, Previous 2021 Guidance was 0.7%

(2) Enterprise level revenue is presented net of intersegment transaction eliminations, including Drug Development COVID-19 Testing revenue

(3) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.4%, Previous 2021 Guidance was 0.3%

(4) 2021 Updated Guidance includes a benefit from foreign currency translation of 2.0%, Previous 2021 Guidance was 1.4%

(5) Free Cash Flow consists of operating cash flow less capital expenditures

Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by dialing 877-898-8036 (720-634-2811 for international callers). The conference ID is 1789612. A telephone replay of the call will be available through August 12, 2021, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The conference ID for the replay is 1789612. A live online broadcast of Labcorp’s quarterly conference call on July 29, 2021, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through July 15, 2022.

MaxCyte Announces Pricing of Upsized Offering and Approval to List on the Nasdaq Global Select Market

On July 29, 2021 MaxCyte, Inc., (LSE: MXCT, MXCN), a leading provider of cell-engineering platform technologies, reported the pricing of its upsized offering of 13,500,000 shares of common stock at an initial offering price of US$13.00 per share (the "Offering") (Press release, MaxCyte, JUL 29, 2021, View Source [SID1234585406]).

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Highlights

Anticipated gross proceeds of approximately US$175,500,000 (or US$201,825,000 if the underwriters exercise their option to purchase additional shares of common stock in full), before deducting underwriting discounts and commissions and estimated offering expenses payable by MaxCyte
MaxCyte intends to use the net proceeds from the Offering for research and development initiatives, to expand its manufacturing capabilities and invest in manufacturing automation, to expand its sales and marketing, business development and field application scientist teams, and for working capital and general corporate purposes
Shares of common stock are expected to commence trading on the Nasdaq Global Select Market ("Nasdaq") on July 30, 2021 under the symbol "MXCT"
MaxCyte has granted the underwriters a 30-day option to purchase up to 2,025,000 additional shares of common stock at the initial offering price per share of common stock less underwriting discounts and commissions.

The closing of the Offering is expected to occur on August 3, 2021, subject to customary closing conditions.

MaxCyte’s common stock will continue to be admitted to trading on the AIM market of the London Stock Exchange (the "AIM") under the symbols "MXCT" and "MXCN." Application is being made for the shares of common stock to be issued at the closing of the Offering to be admitted to trading on AIM under the symbol "MXCT" and it is expected that admission will become effective and dealings in the shares of common stock will commence at 8:00 a.m. (BST) on August 4, 2021.

Cowen, Stifel and William Blair are acting as joint book-running managers for the Offering and as representatives of the underwriters for the Offering. BTIG and Stephens Inc. are also acting as co-managers of the Offering.

A registration statement, including a prospectus, relating to these securities has been filed by MaxCyte and was declared effective by the Securities and Exchange Commission on July 29, 2021. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov. The Offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to and describing the terms of the Offering may be obtained from the offices of Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, USA, Attn: Prospectus Department, by telephone at +1 (833) 297-2926 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, USA, by telephone at +1 (415) 364-2720 or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, USA, by telephone at +1 (800) 621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of any such state or jurisdiction.

Related party transaction

Casdin Partners Master Fund, L.P. ("Casdin") has indicated an interest in purchasing 1,800,000 shares of common stock at the same price and on the same terms as all other participants in the Offering. Immediately following issuance, Casdin would hold a total of 13,971,334 shares of common stock representing, in aggregate, approximately 14% of MaxCyte’s outstanding shares following closing of the Offering.

The participation by Casdin in the Offering constitutes a related party transaction for the purposes of the AIM Rules for Companies. The independent directors for the purposes of the Offering (being the all of the members of MaxCyte’s board of directors), having consulted with MaxCyte’s nominated adviser, Panmure Gordon, consider that the terms of the related party transaction are fair and reasonable insofar as MaxCyte’s shareholders are concerned.

Amendments to the Bylaws

In connection with the Offering, MaxCyte has adopted amended and restated Bylaws (the "Bylaws"), which will take effect immediately before the closing of the Offering. As before, certain rights have been incorporated into the Bylaws which the Company believes stockholders would expect to see in a company whose shares are admitted to trading on a U.S. listed exchange. A copy of the Bylaws will be publicly filed and made available to both Nasdaq and AIM shareholders upon closing of the Offering.