BioCryst to Report Fourth Quarter and Full Year 2020 Financial Results on February 25

On February 11, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its fourth quarter and full year 2020 financial results on Thursday, February 25, 2021 (Press release, BioCryst Pharmaceuticals, FEB 11, 2021, View Source [SID1234574896]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 6779206. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 6779206.

Soligenix to Present at the 2021 BIO CEO & Investor Digital Conference

On February 11, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will deliver a corporate presentation at the BIO CEO & Investor Digital Conference taking place February 16-18, 2021 (Press release, Soligenix, FEB 11, 2021, View Source [SID1234574895]). The presentation will be available to registered conference attendees for on-demand viewing beginning February 15, 2021 at 9:00 AM EST via the virtual conference link. Alternatively, an audio webcast of the Soligenix corporate presentation is available on the Company’s website via this link.

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Key members of Soligenix management will hold one-on-one meetings throughout the conference. Registered conference attendees may schedule a meeting with Soligenix via the conference scheduling link.

"On the heels of our recent SGX301 Commercialization Investor Webcast Event, the BIO CEO conference comes at an opportune time as we advance toward new drug application submission to the FDA, while continuing to highlight SGX301’s unique commercial value proposition for the treatment of cutaneous T-cell lymphoma in the U.S.," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We remain focused on advancing our rare disease pipeline and look forward to meeting with high caliber investment funds and potential pharmaceutical partners during the conference."

Labcorp Announces 2020 Fourth Quarter and Full Year Results and Provides 2021 Guidance

On February 11, 2021 Labcorp (NYSE: LH), a leading life sciences company, reported results for the fourth quarter and year ended December 31, 2020, and full year 2021 guidance (Press release, LabCorp, FEB 11, 2021, View Source [SID1234574894]).

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"Labcorp’s science and innovation throughout the pandemic led to strong performance in the quarter and for the full year. In addition to our leadership in testing, our capabilities are being leveraged to identify variants to the virus through genetic sequencing and to support biotechnology and pharmaceutical companies in developing new therapies and vaccines to fight COVID-19," said Adam Schechter, chairman and CEO, Labcorp.

"We are encouraged about the future of our base business. In the fourth quarter, our base diagnostics business continued to improve as more people focused on managing their health and chronic conditions. Our drug development business also grew and delivered strong quarterly performance, with a book-to-bill of 1.43 on a trailing twelve-month basis driven by strong demand across therapeutic areas.

I want to thank our over 75,000 employees worldwide who have tirelessly served our clients and patients during the pandemic. We are entering 2021 with a renewed commitment to advancing health on a global basis."

Labcorp made substantial progress on its strategic priorities in 2020, which was a transformational year for the company:

Accelerated growth through the power of our platform: Brought Labcorp’s combined science, technology and innovation capabilities to market quickly. Labcorp was the first to receive an FDA Emergency Use Authorization ("EUA") to launch several COVID-19 PCR tests, including the Pixel by Labcorp at-home COVID-19 specimen collection kit for PCR testing, which also received the first EUA to be available through retail without a prescription, and helped bring multiple treatments and vaccines to market in record time. Our science and technology are also being leveraged to genetically sequence thousands of virus samples each week to identify variants that can inform future vaccines and treatments.
Advanced our leadership position in oncology: Expanded Labcorp’s leadership through strategic partnerships in oncology testing, major customer wins in late-stage clinical trials and the addition of leaders in the field to further build our Enterprise Oncology team.
Integrated artificial intelligence, data, digitization and analytics across our business: Increased COVID-19 testing capacity through the use of robotics and technology, and developed proprietary insight and analytics capabilities for clients to improve their operations, guide patient care and support clinical trials across a larger number of programs and therapeutic areas.
Put customers at the center of all that we do: Broadened access of COVID-19 testing to millions of people through hospitals, pharmacies, employers, physicians, drive thrus, and our Pixel by Labcorp at-home collection kit; responded to customer demand by rapidly increasing testing capacity to 275,000 COVID-19 PCR tests per day; delivered test results quickly and more easily through our websites and patient apps; and made testing affordable, charging no upfront out-of-pocket costs to consumers who needed a COVID-19 test.
Evaluated and executed on high-growth opportunities: Focused on deploying shareholder capital to grow the company’s business in diagnostic testing through targeted lab acquisitions, and accelerated wins in clinical trials with the addition of digital and mobile technology capabilities through the acquisitions of GlobalCare and SnapIOT.
Consolidated Results

Fourth Quarter Results

Revenue for the quarter was $4.49 billion, an increase of 52.0% over $2.95 billion in the fourth quarter of 2019. The increase in revenue was due to organic growth of 50.1%, acquisitions of 0.9%, and favorable foreign currency translation of 1.0%. The 50.1% increase in organic revenue includes a 46.4% contribution from COVID-19 Testing and a 3.7% increase in the company’s organic Base Business. "Base Business" includes the company’s business operations except for PCR and antibody COVID-19 testing ("COVID-19 Testing"). The increase in organic Base Business includes the negative impact from lower Medicare and Medicaid pricing as a result of PAMA of (0.6%).

Operating income for the quarter was $1,293.2 million, or 28.8% of revenue, compared to $336.4 million, or 11.4%, in the fourth quarter of 2019. The increase in operating income and margin was primarily due to COVID-19 Testing, organic Base Business growth, acquisitions, and LaunchPad savings, partially offset by the negative impact from PAMA of ($18.3) million and higher personnel costs. The company recorded amortization, restructuring charges, and special items, which together totaled $136.3 million in the quarter, compared to $85.6 million during the same period in 2019. This increase was primarily due to COVID-19 related costs and increased amortization. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $1,429.5 million, or 31.8% of revenue, compared to $422.0 million, or 14.3%, in the fourth quarter of 2019.

Net earnings for the quarter were $938.3 million, compared to $227.1 million in the fourth quarter of 2019. Diluted EPS were $9.54 in the quarter, up from $2.32 in the same period in 2019. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $10.56 in the quarter, up from $2.86 in the fourth quarter of 2019.

Operating cash flow for the quarter was $774.6 million, compared to $569.8 million in the fourth quarter of 2019. The increase in operating cash flow was due to higher cash earnings, partially offset by higher working capital to support growth. In addition, operating cash flow for the fourth quarter of 2020 was reduced by $132.1 million due to the company’s decision to return the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Provider Relief Funds that the company received during the second and third quarters of 2020. Capital expenditures totaled $99.4 million, down from $128.2 million a year ago, despite the expenditures associated with the increase in COVID-19 Testing capacity. As a result, free cash flow (operating cash flow less capital expenditures) was $675.2 million, up from $441.6 million in the fourth quarter of 2019.

At the end of the quarter, the company’s cash balance and total debt were $1.3 billion and $5.8 billion, respectively. During the quarter, the company invested $58.8 million on acquisitions. As of December 31, 2020, the company had $800.0 million of authorization remaining under its share repurchase program.

Full Year Results

Revenue was $13.98 billion, an increase of 21.0% over $11.55 billion last year. The increase in revenue was due to organic growth of 19.0%, acquisitions of 1.8%, and favorable foreign currency translation of 0.4%, partially offset by the disposition of a business of (0.2%). The 19.0% increase in organic revenue includes the 24.1% contribution from COVID-19 Testing, partially offset by the (5.1%) reduction in the company’s organic Base Business due to the pandemic. The decline in organic Base Business includes the negative impact from PAMA of (0.6%).

Operating income was $2.45 billion, or 17.5% of revenue, compared to $1.33 billion, or 11.5%, in 2019. The increase in operating income and margin was primarily due to COVID-19 Testing and LaunchPad savings, partially offset by the negative impact from the pandemic (including the impairments to goodwill and other assets), higher personnel costs, and ($72.1) million from PAMA. The company recorded amortization, restructuring charges, special items, and impairments, which together totaled $886.5 million, compared to $380.6 million in 2019. This increase includes the $437.4 million of COVID-19 related impairments on goodwill and other assets that the company recorded in the first quarter of 2020. In addition, the company recorded $63.9 million of other COVID-19 related costs. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) was $3.33 billion, or 23.8% of revenue, compared to $1.71 billion, or 14.8%, in 2019. The $1.62 billion increase in adjusted operating income and 900 basis point increase in adjusted operating margin were primarily due to the increase in COVID-19 Testing and LaunchPad savings, partially offset by the reduction in the Base Business (due to the pandemic) and higher personnel costs.

Net earnings in 2020 were $1,556.1 million, or $15.88 per diluted share, compared to $823.8 million, or $8.35 per diluted share, in 2019. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $23.94, an increase of 111.5% over $11.32 in 2019.

Operating cash flow was $2.14 billion, compared to $1.44 billion in 2019. The increase in operating cash flow was due to higher cash earnings, partially offset by higher working capital to support growth. Capital expenditures totaled $381.7 million, down from $400.2 million in 2019, despite the expenditures associated with the increase in COVID-19 Testing capacity. As a result, free cash flow (operating cash flow less capital expenditures) was $1.75 billion, compared to $1.04 billion in 2019.

During the year, the company invested $267.6 million on acquisitions, repurchased $100.0 million of stock representing approximately 0.6 million shares, and paid down $412.2 million of debt.

Fourth Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses. The segments that are now referred to as Diagnostics and Drug Development were formerly referred to as LabCorp Diagnostics and Covance Drug Development.

Diagnostics

Revenue for the quarter was $3.15 billion, an increase of 79.5% over $1.76 billion in the fourth quarter of 2019. The increase in revenue was due to organic growth of 78.5%, acquisitions of 0.9%, and favorable foreign currency translation of 0.1%. The 78.5% increase in organic revenue was due to a 78.0% contribution from COVID-19 Testing and a 0.5% increase in the Base Business, which includes the negative impact from PAMA of (1.0%). This represents the first quarter of 2020 with organic Base Business revenue growth versus prior year.

Total volume (measured by requisitions) increased by 33.9% as organic volume increased by 33.3% and acquisition volume contributed 0.6%. The organic volume growth was due to the 41.0% contribution from COVID-19 Testing demand, partially offset by a (7.7%) reduction in the Base Business volume due to the pandemic. Price / mix increased by 45.5% primarily due to COVID-19 Testing of 37.0% and organic Base Business of 8.2%, which includes the negative impact from PAMA of (1.0%). In the fourth quarter, Diagnostics achieved its highest contribution from COVID-19 Testing volume, as well as the strongest year-over-year volume in the Base Business since the pandemic began in March 2020.

Adjusted operating income for the quarter was $1,234.4 million, or 39.1% of revenue, compared to $277.1 million, or 15.8%, in the fourth quarter of 2019. The $957.3 million increase in adjusted operating income and 2,340 basis point increase in adjusted operating margin were primarily due to the increase in COVID-19 Testing and LaunchPad savings, partially offset by the negative impact from PAMA of ($18.3) million and 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. The company continues to develop and execute new LaunchPad programs to support profitable growth in Diagnostics.

Drug Development

Revenue for the quarter was $1.40 billion, an increase of 16.4% over $1.20 billion in the fourth quarter of 2019. The increase in revenue was due to organic growth of 13.1%, acquisitions of 0.9%, and favorable foreign currency translation of 2.3%. The 13.1% increase in organic revenue was due to an 8.4% increase in the Base Business and a 4.7% contribution from COVID-19 Testing performed through its Central Laboratories business. While continuing to be negatively impacted by the pandemic, Drug Development achieved its highest quarter of organic Base Business growth in 2020, benefiting from broad-based demand across all service lines, including COVID-19 vaccine and therapeutic work.

Adjusted operating income for the quarter was $248.4 million, or 17.8% of revenue, compared to $183.2 million, or 15.2%, in the fourth quarter of 2019. The $65.2 million increase in adjusted operating income and 250 basis point increase in adjusted operating margin were primarily due to COVID-19 Testing, organic Base Business demand, and LaunchPad savings, partially offset by higher personnel costs. The company achieved its goal to deliver approximately $150 million of net savings from its three-year Drug Development LaunchPad initiative. While the target was achieved, the company continues to develop and execute new LaunchPad programs to support profitable growth in Drug Development.

Net orders and net book-to-bill during the trailing twelve months were $6.96 billion and 1.43, respectively. Backlog at the end of the quarter was $13.76 billion, compared to $12.46 billion last quarter, and the company expects approximately $4.5 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2021

The following guidance assumes foreign exchange rates effective as of December 31, 2020 for the full year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions and share repurchases.

(1) 2021 Guidance includes a benefit from foreign currency translation of 0.9%.

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

(3) 2021 Guidance includes a benefit from foreign currency translation of 0.1%.

(4) 2021 Guidance includes a benefit from foreign currency translation of 2.2%.

(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 7378794. A telephone replay of the call will be available through Feb. 25, 2021, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The conference ID for the replay is 7378794. A live online broadcast of Labcorp’s quarterly conference call on Feb. 11, 2021, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through Jan. 28, 2022.

Ipsen delivered sales growth and margin expansion in 2020 – Focused on executing new strategy and delivering financial objectives in 2021

On February 11, 2021 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its financial results for the full year 2020 (Press release, Ipsen, FEB 11, 2021, View Source [SID1234574893]).

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Solid full year 2020 financial results in a COVID-19 environment
Group sales of €2,592 million, growing by 3.0%1 at constant currency or 0.6% as reported, driven by Specialty Care sales growth of 5.9%1, reflecting a resilient oncology portfolio, while Consumer Healthcare sales were down 21.3%1 mostly due to the impact of COVID-19.
Core Operating margin at 32.0% of the sales, up 1.6 points. IFRS Operating margin at 20.1% of the sales, up 21.4 points.
Core consolidated net profit of €610.5 million, with fully diluted Core EPS growing by 8.4% to reach €7.31. IFRS Consolidated net profit showing a gain of €548.9 million, with IFRS net earnings per share of €6.57.
Sound financial structure, with a closing Net Debt of €525.3 million and a Net Debt to EBITDA ratio of 0.6x. Strong Free Cash Flow at €646.4 million, up 38%, mainly driven by higher Operating Cash Flow.
Advancing solid pipeline in H2 2020
Cabometyx (cabozantinib) in combination with nivolumab for 1L renal cell carcinoma (RCC) filing with EMA based on successful Phase 3 CheckMate -9ER;
Onivyde (irinotecan liposome injection) received Fast Track designation from the FDA for 2L Small Cell Lung Cancer (SCLC);
Palovarotene on track for NDA and MAA submissions for fibrodysplasia ossificans progressiva (FOP).
Proposed dividend of €1.00 per share2 for the 2020 financial year, consistent with the prior year.
2021 guidance3 of Group sales growth greater than 4.0% at constant currency and Core Operating margin greater than 30.0% of the sales.
Executing on new strategy presented in December 2020: Together. For patients and society.

David Loew, Chief Executive Officer of Ipsen, stated: "I am truly proud of Ipsen’s performance in 2020. We met our financial objectives, delivering steady top-line growth, significant core operating margin expansion and strong cash flow generation to fund our external innovation strategy. The fact these achievements took place against the backdrop of the pandemic is remarkable and speaks to the dedication and patient-centricity of our highly motivated employees. We made encouraging pipeline progress, especially in Oncology. In December we announced our new strategy which will drive long-term value for all our stakeholders: Focus. Together. For patients & society. While the world continues to face uncertain business conditions in 2021, I am confident that Ipsen will build on its strong foundations and execute on its strategy to deliver another successful year."

New Strategy
Ipsen is executing on the four key pillars of its new strategy presented in December 2020:

The Group is focused on maximizing the value of its current Specialty Care product portfolio through commercial excellence and geographic expansion. It aims to maximize its core brands and capture the full potential of its innovative oncology products. A strategic review of the Consumer Healthcare business is proceeding.
Ipsen’s priority is to build a sustainable pipeline to drive long-term growth. Recent initiatives have prioritized the pipeline on the highest potential opportunities and progressed the transformation of the R&D organization. Ipsen is strengthening its external innovation efforts by targeting differentiated medicines in its three core therapeutics areas of Oncology, Rare Disease and Neuroscience, with a broader disease and modality scope than previously defined, and across all stages of clinical development.
The company is committed to generating efficiencies through a focused and agile operating model. Leveraging smart spending, streamlined operations, manufacturing efficiencies and optimizing digitalization, the Group will be able to reinvest in R&D and external innovation to fuel future growth.
Patients and society are at the core of Ipsen’s mission, starting with fully engaged employees and a culture of accountability to perform and compete in the long term. Ipsen is highly committed to its corporate social responsibility (CSR) initiatives which are centered around employees, community and the environment, as reflected throughout the organization and in the inclusion of responsibility metrics in management compensation.

2021 Financial guidance
The Group has set the following financial targets for the current year, assuming a progressive recovery from COVID-19 by H2 2021:

Group sales growth year-on-year greater than 4.0% at constant currency1, with an expected negative 3.0% impact of currency based on the level of exchange rates at the end of January 2021;
Core Operating margin greater than 30.0% of the sales, excluding any potential impact of incremental investments from external innovation.
This guidance assumes a phased launch of lanreotide generic in Europe by mid-2021 and a limited impact in case of a potential launch of octreotide or lanreotide generics in the U.S.

Group sales reached €2,591.6 million, up 3.0%1 year-on-year.

Specialty Care sales reached €2,381.1 million, up 5.9%1, driven by the continued strong growth of Somatuline (lanreotide) and Cabometyx. Somatuline growth of 13.1%1 was driven by continued positive momentum in North America with a double-digit growth (17.0%1) and solid performance throughout Europe despite the availability of the octreotide generic. Dysport (botulinum toxin type A) down by 3.4%1, was impacted in most geographies by the closure of treatment centers resulting from COVID-19 despite a faster recovery in the aesthetics market. Decapeptyl (triptorelin) sales reflected good volume growth across Major European countries offset by lower volumes in China.

Consumer Healthcare sales reached €210.6 million, down 21.3%1, mainly due to a decline in Smecta (diosmectite) sales impacted by COVID-19, the implementation of hospital central procurement in China and lower performance in France.

Core Operating Income reached €829.3 million in 2020, compared to €782.6 million in 2019, a growth of 6.0%, driven by sales growth, Group-wide efficiencies and costs savings with less travel, medical and marketing expenses due to COVID-19 partially offset by continued investment in R&D to advance key programs in Oncology, Rare Disease and Neuroscience.

Core Operating margin reached 32.0% of the sales, up 1.6 points compared to 2019.

Core consolidated net profit was €610.5 million in 2020, an increase of 8.4% versus €563.4 million in 2019, driven by higher Core Operating Income.

Fully diluted Core EPS (earnings per share) grew by 8.4% to reach €7.31, compared to €6.74 in 2019.

IFRS Fully diluted EPS was a net profit per share amounting to €6.57 versus a net loss of €0.61 in 2019.

Free Cash Flow reached €646.4 million, up by €178.7 million, mainly driven by higher Operating Cash Flow thanks to a lower level of capital expenditures and working capital partly offset by higher cash out from restructuring costs, financial result and current income tax.

Closing net debt reached €525.3 million at the end of 2020, as compared to closing net debt in 2019 of €1,115.6 million.

Conference call
Ipsen will hold a conference call Thursday, 11 February 2021 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately five to ten minutes prior to its start. No reservation is required to participate in the conference call.

Pulmatrix Announces $40 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

On February 11, 2021 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported that it has entered into definitive agreements with healthcare-focused institutional investors for the purchase and sale of 20,000,000 shares of the Company’s common stock, at a purchase price of $2.00 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Pulmatrix, FEB 11, 2021, View Source [SID1234574892]). The closing of the offering is expected to occur on or about February 16, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to Pulmatrix from this offering are expected to be $40,000,000, before deducting the placement agent’s fees and other offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The shares of common stock (are being offered by Pulmatrix pursuant to a "shelf" registration statement on Form S-3 (File No. 333-230225) previously filed with the Securities and Exchange Commission (the "SEC") on March 12, 2019 and declared effective by the SEC on March 15, 2019. The offering of the securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at .

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