Savara Reports First Quarter 2020 Financial Results and Provides Business Update

On May 7, 2020 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the first quarter ending March 31, 2020 and provided a business update (Press release, Savara, MAY 7, 2020, View Source [SID1234557408]).

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"With the recent clarity around the IMPALA 2 study design, along with the expansion of our pipeline with the Phase 3 Apulmiq development program, 2020 has kicked off with a strong start," said Rob Neville, Chief Executive Officer, Savara. "We are now working diligently to get these two studies initiated as soon as possible."

Recent Developments

Molgradex for autoimmune pulmonary alveolar proteinosis (aPAP)

Based on discussions with the U.S. Food and Drug Administration (FDA), the Company believes the second Phase 3 study will be a randomized, double-blind, placebo-controlled study of Molgradex 300 µg administered once daily continuously compared to matching placebo over 48 weeks. The primary endpoint will be change from baseline to week 24 in diffusion capacity of the lungs (DLCO) percent predicted. Secondary endpoints will be change in baseline to week 24 in St. George’s Respiratory Questionnaire (SGRQ) Total Score, SGRQ Activity Component, and exercise capacity using a treadmill test.
Apulmiq for non-cystic fibrosis bronchiectasis (NCFB)

Obtained the global rights to develop and commercialize Apulmiq (inhaled ciprofloxacin).
The Company expects to work with the FDA to plan a confirmatory Phase 3 study that will be based on key learnings from previous studies of inhaled antibiotics for NCFB.
AeroVanc for methicillin-resistant Staphylococcus aureus (MRSA) lung infection

Due to COVID-19 concerns, the Company closed enrollment in the Phase 3 AVAIL study. Total target enrollment was 200 patients. Enrollment in the adult population completed, with 55 patients out of a target of 50. One hundred and thirty-three patients were enrolled in the primary analysis population (younger patients between 6-21 years of age) out of a target of 150. Top line results are still expected in early 2021.
Molgradex for nontuberculous mycobacterial (NTM) lung infection

Due to COVID-19 concerns, the Company closed enrollment in the Phase 2a ENCORE study. Fourteen patients out of a target of ~30 were enrolled. Despite closing enrollment early, data from the enrolled patients will provide useful information on the safety, and potential efficacy, of Molgradex in people living with cystic fibrosis who have NTM lung infection.
First Quarter Financial Results (Unaudited)

Savara’s net loss attributable to common stockholders for the three months ended March 31, 2020 was $15.4 million, or $(0.27) per share, compared with a net loss attributable to common stockholders of $12.1 million, or $(0.34) per share, for the three months ended March 31, 2019.

Research and development expenses were $13.2 million for the three months ended March 31, 2020, compared with $10.0 million for the three months ended March 31, 2019. The increase was primarily due to approximately $5.4 million equal to the aggregate of the fair value of Savara common stock to be issued and cash remunerated to the licensor under the development and commercialization licensing rights to Apulmiq. The upfront license payment expenses were offset by decreased development costs associated with the development of Molgradex and AeroVanc in the amount of $1.7 million and $0.5 million, respectively.

General and administrative expenses for the three months ended March 31, 2020 were $3.0 million, compared with $2.8 million for the three months ended March 31, 2019. The increase was primarily due to increased noncash stock-based compensation charges, personnel costs, and corporate insurance costs for the three months ended March 31, 2020.

As of March 31, 2020, Savara had debt of approximately $25.0 million and cash, cash equivalents, and short-term investments of approximately $105 million. Under the current operating plan, the Company believes this is sufficient capital to fund planned operations into 2022.

Conference Call/Webcast

Savara management will host a conference call/webcast today at 4:30 p.m. Eastern Time (ET) / 1:30 p.m. Pacific Time (PT). Shareholders and other interested parties may access the call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and requesting the "Savara Inc." call. A live webcast of the call can be accessed on the Investors page of Savara’s website at View Source

Approximately one hour after the call, a telephone replay will be available and will remain available through May 14, 2020 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10143130. A webcast replay will be available on the Investors page of Savara’s website and will remain available for 30 days.

Ascentage Pharma’s Core Drug Candidate HQP1351 Granted Fast Track Designation by the US FDA, Marking Another Milestone in Its Development

On May 7, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the US Food and Drug Administration (FDA) has granted HQP1351, the Company’s core drug candidate, a Fast Track Designation (FTD) for the treatment of patients with chronic myeloid leukemia (CML) with certain genetic mutations who have failed to respond to treatments with existing tyrosine kinase inhibitors (TKIs) (Press release, Ascentage Pharma, MAY 7, 2020, View Source [SID1234557407]). This is the first FTD obtained by Ascentage Pharma, and it marks another milestone for HQP1351 following its recent Orphan Drug Designation by FDA.

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FTD is designed by FDA to expedite the development and review of drug candidates to treat serious disease/conditions that present urgent unmet clinical needs. This FTD for HQP1351 will lead to a series of benefits that could accelerate the clinical development and review for this drug candidate, including more frequent communications and meetings with FDA during the clinical development; and being allowed to enter Rolling Review, a process that allows the company to submit New Drug Applications (NDAs) by sections, rather than waiting until all required materials become available. This FTD also paves the way for HQP1351 to be qualified for Accelerated Approval and Priority Review designations in the future.

A key factor in determining FTD for a drug candidate is its ability to address an unmet medical need with additional clinical benefits to patients. To qualify for FTD, a drug candidate needs to demonstrate its potential to treat a condition with no existing therapies, offer significant clinical advantages over current treatment options, or bring clinical benefits to patients intolerant to existing therapies or with poor responses to them. This FTD represents FDA’s recognition of HQP1351’s potential in addressing some of these unmet medical needs.

CML is a rare hematologic malignancy with an annual incidence rate of approximately 1.9 cases/100,000. BCR-ABL tyrosine kinase inhibitors (TKIs) have significantly improved clinical management of CML. However, despite clinical benefits offered by the first-generation BCR-ABL inhibitor imatinib (Gleevec), and several second-generation TKIs, many patients develop drug resistance. Such acquired resistance to TKIs is a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with the T315I mutation are resistant to both first- and second-generation BCR-ABL inhibitors, hence presenting an urgent unmet medical need for next-generation BCR-ABL inhibitors to more effectively target the T315I mutation. Although a third-generation TKI has already been approved in the United States, there are remaining concerns about its safety As a result, patients who failed to respond to existing TKI therapies continue to present an urgent unmet clinical need for safer and more effective therapies.

HQP1351 is a novel, orally active, potent third-generation BCR-ABL inhibitor designed to effectively target BCR-ABL mutants, including T315I, and it is being developed for the treatment of patients with CML resistant to first- and second-generation TKIs. HQP1351 is the first China-developed third-generation BCR-ABL inhibitor targeting drug-resistant CML. The drug candidate is currently being evaluated in pivotal Phase II studies in China, and Ascentage Pharma plans to submit an NDA for HQP1351 this year. In July 2019, HQP1351 was cleared by FDA to enter a Phase Ib study. Data from the Phase I clinical study of HQP1351 were selected for oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meetings two years in a row and was nominated as "Best of ASH (Free ASH Whitepaper)" research in 2019. Early data from studies of HQP1351 have demonstrated promising efficacy as well as favorable safety and tolerability profiles.

"Drug resistance to earlier-generation TKI represents an urgent unmet clinical need globally. HQP1351 is a novel, orally active, and potent third-generation BCR-ABL inhibitor being developed by an innovative biopharmaceutical company in China. In our Phase I study with a large sample size of more than 100 patients, HQP1351 demonstrated promising efficacy and a favorable safety profile, with clinical responses in many patients with relapsed or refractory CML who had no effective treatment option," Professor Xiaojun Huang, Director of the Institute of Hematology, Peking University, and the principal investigator of HQP1351 in China. "HQP1351 has the potential of becoming a new option in the clinical management of drug-resistant CML, symbolizing the great advances in biopharmaceutical R&D in China. This FTD by FDA signifies global recognition of the clinical data from China studies, and will hopefully soon benefit patients with CML worldwide. We look forward to further progress in the clinical development of HQP1351."

"HQP1351 is a China-developed third-generation BCR-ABL inhibitor. With this Fast Track Designation, received right after the recent Orphan Drug Designation by FDA, Ascentage Pharma has reached another major milestone in the global development of HQP1351," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "These two designations for HQP1351 indicate the urgency for addressing the unmet clinical need in the treatment of CML, and a recognition of HQP1351’s promising efficacy and safety profile by an ex-China health authority as supported by existing data. This FTD will help strengthen our communications and collaboration with FDA in future clinical development and expedite the development and review of HQP1351 in the US. Staying committed to the mission of addressing unmet clinical needs in China and around the world, we will further accelerate the clinical development of HQP1351 to hopefully soon provide a safer and more effective treatment option to patients with CML."

Palatin Technologies, Inc. to Report Third Quarter Fiscal Year 2020 Results; Teleconference and Webcast to be held on May 12, 2020

On May 7, 2020 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its third quarter fiscal year 2020 operating results on Tuesday, May 12, 2020 before the open of the U.S. financial markets (Press release, Palatin Technologies, MAY 7, 2020, View Source [SID1234557406]).

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Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on May 12, 2020 at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

Schedule for the Operating Results Press Release, Conference Call / Audio Webcast

Q3 Fiscal Year 2020 Financial Results Press Release

5/12/2020 at 7:30 a.m. ET

Q3 Fiscal Year 2020 Conference Call-Live

5/12/2020 at 11:00 a.m. ET

US/Canada Dial-In Number:

1-888-204-4368

International Dial-In Number:

1-323-994-2082

Conference ID:

8845359

Q3 Fiscal Year 2020 Conference Call-Replay

5/12/2020-5/19/2020

US/Canada Dial-In Number:

1-888-203-1112

International Dial-In Number:

1-719-457-0820

Replay Passcode:

8845359
Audio Webcast Live and Replay Access

View Source

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source.

Evogene Financial Results and Earnings Announcement Schedule for the First Quarter of 2020

On May 7, 2020 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN.TA), a leading biotechnology company aiming to revolutionize the development of novel products for life-science based industries by utilizing cutting edge computational biology technologies, reported that it will release its financial results for the first quarter 2020 on Tuesday, May 26, 2020 (Press release, Evogene, MAY 7, 2020, View Source [SID1234557405]).

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On the day of the announcement, the Company’s management will host a conference call to discuss the results at 09:00 AM Eastern time, 16:00 Israel time. To access the conference call, please dial 1-888-668-9141 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

A replay of the conference call will be available approximately three hours following the completion of the call. To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5904 internationally. The replay will be accessible through May 28th, 2019, and an archive of the webcast will be available on the Company’s website for the following 30 days.

Heska Corporation Reports First Quarter 2020 Results

On May 7, 2020 Heska Corporation (NASDAQ: HSKA; "Heska" or "Company"), a leading provider of advanced veterinary diagnostic and specialty products, reported financial results for its first quarter ended March 31, 2020 (Press release, Heska, MAY 7, 2020, View Source [SID1234557404]). The Company reports two segments: Core Companion Animal ("CCA") and Other Vaccines & Pharmaceuticals ("OVP"). The Company forecast provided during the February 25, 2020 release is referred to as "2020 Outlook".

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(1) "PVD" is Pharmaceuticals, Vaccines and Diagnostic, and includes Tri-Heart heartworm. (2) "bps" is basis points. (3) See "Use of Non-GAAP Financial Measures" and the related reconciliations provided below.
Note: Numbers may not foot due to rounding.

Kevin Wilson, Heska’s Chief Executive Officer and President, commented, "It is with mixed emotions that I report that the first quarter of 2020 was a strong start to the year for Heska. By grace alone, our extended Heska family in North America, Europe, Australia, and Malaysia is safe, employed and healthy. We are filled with thanks for our unmerited good fortune and we grieve for those who have been directly and tragically affected by COVID-19. Our business concerns pale in comparison to their health and value. It is with sincere humility that we give thanks for own good fortune and health and we carry on with our professional and personal duties each day.

In the first quarter, Heska grew revenue, expanded margins, achieved major strategic milestones, reaffirmed the benefits of a secure subscriptions model, improved our balance sheet, added to our cash position, and advanced our research and development projects. In the face of a global COVID-19 crisis, our accomplishment in nearly all key areas met or exceeded our goals in the quarter.

Heska strongly performed in our most important Point of Care ("POC") Lab Consumables business, which was up 15.7% over the prior year period.
Heska completed the on-time acquisition of scil animal care company GmbH ("scil") for $110 million dollars, when most global M&A transactions were paused or terminated.
Heska adjusted exceptionally well to the COVID-19 crisis by protecting employees and their families, pets and their families, veterinary teams and their families, and Heska’s commercial capacity, brand and culture. Our business continuity plans are working well."
Mr. Wilson continued, "Risks properly identified and pressure thoughtfully managed can produce opportunities for prepared growth companies like Heska during times of crisis. We believe Heska is well prepared and positioned. Our end markets remain fundamentally healthy and our supply chain is intact. Our balance sheet is in great shape and our cash on-hand projections, even in severely down-market scenarios, confirm our long-term ability to simultaneously perform financially and pursue growth strategies. With these foundations in place, Heska accomplished a great deal in the first period of 2020 and we continue to expect positive progress throughout the balance of the year."

Impact of COVID-19 Pandemic on Our People.

In the latter half of the quarter, we experienced modest impact from government restrictions on the movement of people, goods, and services. Fortunately, those we serve, veterinarians and herd animal health experts, are deemed essential services in areas of government mandated restrictions. To service them safely and efficiently, Heska teams quickly adjusted to a targeted, remote workforce posture and put the care and health of people and our brand first. Heska has not laid off or furloughed employees nor reduced the salaries they and their families depend upon, because the data and business fundamentals have not supported the need for such measures. We have been fortunate. Our investment in people has been both the right thing to do and also good for business. Our associates and customers have responded to our support by showing great care for each other and Heska through strong loyalty and increased performance in key business and relational areas; these benefits have continued into the second quarter.

Impact of COVID-19 Pandemic on Our Business.

Because of social distancing measures, on-site installations of POC Lab and Imaging equipment will experience intermittent delays. While not significant to the overall results of the first quarter, on-site installations of equipment were impacted in March. We anticipate the impact to on-site installations and capital equipment expenditures to continue for at least the remainder of 2020.

While we have experienced some intermittent delays in receiving supply, Heska’s supply chain has not been significantly impacted and we do not expect material changes to current supply availability trends over the remaining months of 2020.

Our major research and development projects are continuing to progress substantially as planned, but we have experienced sporadic delays receiving validation samples and device components as well as inefficiencies in remote collaboration and field-testing. We anticipate these delays to result in slippage of 90 to 120 days in our new products’ commercial roll-out schedules. While these delays are unfortunate, we are taking the additional time to improve product features and benefits.

We do not know how long COVID-19 related challenges will continue. The ultimate impact on our business will depend on many factors substantially beyond our control and difficult to predict. In the near-term and with asynchronous variation across geographies, we anticipate some veterinary hospitals will temporarily: (1) realize lower average diagnostics use as a result of deferred and elective patient visits, and (2) delay capital equipment investments as a result of heightened conservatism and the effects of social distancing on in-clinic demonstrations and installations. Despite these headwinds, we believe we are well positioned; (1) our customers and products are essential, (2) our main POC Lab business continues to show healthy consumables use and margin, (3) our subscriptions model metrics continue to show solid performance, (4) our vaccines and pharmaceuticals business continues to track our 2020 Outlook, (5) our balance sheet is strong, and (6) our employees, logistics, supply chain, and operations continue to operate well in the current environment and they are prepared for both a staged return and an instant-on return to full capacity.

International Expansion

scil animal care company, Germany. Heska worked diligently throughout the first quarter to finalize the acquisition of scil. This represents a transformative milestone in the Company’s long-term strategic plan. scil is a proven European based leader in veterinary point of care laboratory and imaging diagnostics, with a significant, longstanding base of loyal customers, a top three market position in Germany, France, Italy, Spain and Canada, and a growing presence in the United Kingdom, Scandinavia, Eastern Europe, Latin America and Malaysia. Heska’s combination with scil creates a unified and difficult-to-replicate global veterinary diagnostics company with critical market share leadership in key countries to service millions of pets through tens of thousands of veterinarians and active point of care analyzers around the world.

Summary

"I believe that properly prepared companies, in structurally sound industries, that invest in their people and capabilities during difficult times like these will be in a position for above market performance when uncertainty recedes. Heska intends to be one of these companies. Our capabilities and end markets are intact. While no business will be left untouched by COVID-19, we are well positioned. We will continue to secure past wins, pressure test and adjust to risks, invest for long-term gain, and build the strengths of our team and end markets. Our balance sheet is strong, our end markets are fundamentally healthy, our addressable geographies and customers have recently doubled, our innovation pipeline is packed and progressing for major launches in 2020 and 2021, and we are positioned well to grow. Pet healthcare broadly and Heska specifically are wonderful places in which to invest for the future, especially in uncertain times, and I am excited to prudently continue to do so," concluded Mr. Wilson.

Financial Results

Revenue

2020 first quarter revenue was $30.7 million, a 3.9% increase from $29.5 million in the first quarter of 2019. CCA segment revenue increased 10.5% to $27.3 million, from $24.7 million in the first quarter of 2019. The $2.6 million increase was driven by a 15.7% increase in POC Lab Consumables and a $1.9 million increase in PVD related to the contract manufactured heartworm preventive, Tri-Heart, which had reduced channel demand in 2019. These increases were partially offset by a 22.3% decrease in capital lease placements and outright sales of POC Lab Instruments and a 10.3% decrease in POC Imaging sales.

OVP segment revenue decreased 30.2% to $3.3 million in the first quarter of 2020, compared to $4.8 million in the first quarter of 2019. The decrease was driven primarily by reduced customer requirements compared to the first quarter of 2019.

Gross Profit

Gross profit increased 7.2% to $13.4 million in the first quarter of 2020, compared to $12.5 million in the first quarter of 2019. Gross margin increased to 43.9% in the first quarter of 2020, compared to 42.5% in the first quarter of 2019. The increase in both gross profit and gross margin percentage was driven primarily by favorable product mix related to increased revenue from consumable sales.

Operating Expenses

Total operating expenses in the first quarter of 2020 were $18.1 million (58.9% of sales), compared to $12.6 million (42.8% of sales) in the prior year. The increase is driven primarily by $3.9 million of one-time acquisition and restructuring costs related to the acquisition of scil. The remaining variance is related to increased investments in research and development of $0.8 million relating to our new product initiatives. Finally, the increase in sales and marketing is as a result of international expansion, both organic and inorganic.

Net Loss Attributable to Heska and EPS

Net loss attributable to Heska was $5.3 million for the three months ended March 31, 2020, compared to net income attributable to Heska of $0.8 million in the prior year period. Net loss per diluted share for the first quarter 2020 was $0.70 compared to net income per diluted share for the first quarter of 2019 of $0.10. Net income is lower in the three months ended March 31, 2020 as compared to the three months ended March 31, 2019 due to increases operating expenses as discussed above, as well as cash interest and amortization charges relating to the Convertible Notes issued in the third quarter of 2019.

Adjusted EBITDA and Non-GAAP EPS

Adjusted EBITDA for the first quarter 2020 was $0.9 million (3.0% adjusted EBITDA margin) compared to $2.2 million (7.6% adjusted EBITDA margin) in the first quarter 2019. Non-GAAP EPS was a loss of $0.14 per diluted share for the first quarter 2020 compared to earnings of $0.09 per diluted share in the first quarter 2019. The decline in both metrics is due to purposeful investment in research and development and international expansion of sales and marketing. Refer to ‘Reconciliation of GAAP to Non-GAAP’ included with this release.

Balance Sheet

For the three months ended March 31, 2020, we had $191.2 million of cash and cash equivalents and working capital of $223.8 million. Net cash used in operating activities was $4.8 million in the three months ended March 31, 2020 compared to net cash provided by operating activities of $0.7 million for the three months ended March 31, 2019. Net cash used in investing activities was $14.6 million in the first quarter 2020 compared to $0.5 million in the first quarter of 2019 driven by $14.4 million payment of consideration for the December 2019 acquisition of CVM Diagnostico Veterinario, S.L. and CVM Ecografía, S.L. (referred to collectively as "CVM"). Net cash provided by financing activities was $121.6 million in the first quarter 2020 compared to net cash used in financing activities of $4.6 million for the first quarter 2019. The change was driven by an $122.0 million increase in proceeds from the issuance of preferred stock in anticipation of the acquisition of scil. Approximately $111.0 million was used subsequent to the first quarter for consideration in the acquisition of scil.

2020 Combined Outlook

As previously discussed, Heska currently anticipates that its operations, for at least the remainder of 2020, will be adversely impacted by the current economic environment and COVID-19 social distancing strategies, especially as it relates to on-site installation and sale of capital equipment. Considering the impact and the potential impact resulting from COVID-19 on Heska’s organic growth as well as on the recently acquired scil European (primarily) business, we have revised the Company’s consolidated 2020 Outlook.

The table below introduces fiscal year 2020 guidance ranges ("2020 Combined Outlook") for revenue and adjusted EBITDA margin for Heska Corporation compared to previous Heska Corporation stand-alone guidance presented in the February 25, 2020 Earnings Release. Among the factors and metrics considered in Heska’s 2020 Combined Outlook, Heska stand-alone net customer acquisition forecast decreased approximately 50-60% due to updated COVID-19 related scenario assumptions.

Excludes estimates for taxes, interest, depreciation and amortization, acquisition and other one-time costs, and stock-based compensation.

Excludes impact of scil acquisition.

Heska is unable to provide a reconciliation of the non-GAAP guidance measure to the corresponding GAAP measure on a forward-looking basis without unreasonable effort due to the high variability and low visibility of most of the excluded items. Material changes to any one of these items could have a significant impact on future GAAP results. Heska believes the non-GAAP presentation is more in-line with future ongoing operating performance.

2020 Investor and Analyst Day and Multi-Year Outlook

The Company plans to host an Analyst and Investor Day on November 12, 2020 (formerly September 2020) in New York City, pending evaluation of the then-current COVID-19 situation, to discuss the Company’s growth strategy, consolidated performance including its recent major acquisitions, Element UF demonstration, and multi-year outlook. Details surrounding the event will be forthcoming.

Investor Conference Call

Management will conduct a conference call on May 7, 2020 at 9 a.m. MT (11 a.m. ET) to discuss the first quarter 2020 financial results. To participate, dial 1-866-548-4713 (domestic) or 1-323-794-20933 (international) and reference conference call access number 3918137. The conference call will also be broadcast live over the Internet at www.heska.com. To listen, simply log on to the web at this address at least ten minutes prior to the start of the call to register and download and install any necessary audio software. Telephone replays of the conference call will be available for playback until May 21, 2020. The telephone replay may be accessed by dialing 1-844-512-2921 (domestic) or 1-412-317-6671 (international). The replay access number is 3918137. The webcast will also be archived on www.heska.com for 90 days.